MX7/MX7T/Vaus7/Zeus/ME7/Anesus

ME7/Anesus ME7T/MX7P/MX7W/MX8/
MX8T/Vaus8/ME8
Diagnostic Ultrasound System
Operator’s Manual
[Basic Volume]
 ©2024 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All Rights Reserved.
For this Operator’s Manual, the issue date is 2024-01.

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called
Mindray) owns the intellectual property rights to this Mindray product and this manual. This
manual may refer to information protected by copyright or patents and does not convey any license
under the patent rights or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential information. Disclosure of
the information in this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaptation, translation or any other
derivative work of this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden.

is the trademarks, registered or otherwise, of Mindray in China and other countries. All
other trademarks that appear in this manual are used only for informational or editorial purposes.
They are the property of their respective owners.
This posting serves as notice under 35 U.S.C.§287(a) for Mindray patents:
http://www.mindrayna.com/patents.

Responsibility on the Manufacturer Party

Contents of this manual are subject to change without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be liable for
errors contained herein or for incidental or consequential damages in connection with the
furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product, only if:
• all installation operations, expansions, changes, modifications and repairs of this product are
conducted by Mindray authorized personnel;
• the electrical installation of the relevant room complies with the applicable national and local
requirements; and
• the product is used in accordance with the instructions for use.

NOTE:
This equipment must be operated by skilled/trained clinical professionals.

WARNING
It is important for the hospital or organization that employs this equipment to
carry out a reasonable service/maintenance plan. Neglect of this may result in
machine breakdown or personal injury.

I
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or other
charges or liability for direct, indirect or consequential damages or delay resulting from the
improper use or application of the product or the use of parts or accessories not approved by
Mindray or repairs by people other than Mindray authorized personnel.
This warranty shall not extend to:
• Malfunction or damage caused by improper use or man-made failure.
• Malfunction or damage caused by unstable or out-of-range power input.
• Malfunction or damage caused by force majeure such as fire and earthquake.
• Malfunction or damage caused by improper operation or repair by unqualified or unauthorized
service people.
• Malfunction of the instrument or part whose serial number is not legible enough.
• Others not caused by instrument or part itself.

Customer Service Department

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address: Mindray Building, Keji 12th Road South, High-tech industrial park,
Nanshan, Shenzhen 518057, P.R.China
Website: www.mindray.com
E-mail Address: service@mindray.com
Tel: +86 755 81888998
Fax: +86 755 26582680

Manufacturer: Mindray DS USA, Inc.

Address: 800 MacArthur Blvd.
Mahwah, NJ 07430-0619 USA
Tel: +1(201) 995-8000
Toll Free: +1 (800) 288-2121
Fax: +1 (800) 926-4275

Important Information
• It is the customer’s responsibility to maintain and manage the system after delivery.
• The warranty does not cover the following items, even during the warranty period:

II
 – Damage or loss due to misuse or abuse.
– Damage or loss caused by Acts of God such as fires, earthquakes, floods, lightning, etc.
– Damage or loss caused by failure to meet the specified conditions for this system, such as
inadequate power supply, improper installation or environmental conditions.
– Damage or loss due to use of the system outside the region where the system was
originally sold.
– Damage or loss involving the system purchased from a source other than Mindray or its
authorized agents.
• This system shall not be used by persons other than fully qualified and certified medical
personnel.
• DO NOT make changes or modifications to the software or hardware of this system.
• In no event shall Mindray be liable for problems, damage, or loss caused by relocation,
modification, or repair performed by personnel other than those designated by Mindray.
• The purpose of this system is to provide physicians with data for clinical diagnosis. The
physician is responsible for the results of diagnostic procedures. Mindray shall not be liable for
the results of diagnostic procedures.
• Important data must be backed up on external memory media.
• Mindray shall not be liable for loss of data stored in the memory of this system caused by
operator error or accidents.
• This manual contains warnings regarding foreseeable potential dangers, but you shall also be
continuously alert to dangers other than those indicated. Mindray shall not be liable for
damage or loss resulting from negligence or ignorance of the precautions and operating
instructions described in this operator’s manual.
• If a new manager takes over this system, be sure to hand over this operator’s manual to the new
manager.

About This Manual

This operator’s manual describes the operating procedures for this diagnostic ultrasound system
and the compatible probes. To ensure safe and correct operation, carefully read and understand the
manual before operating the system.

Meaning of Signal Words

In this manual, the signal words DANGER, WARNING, CAUTION, NOTE
and TIP are used regarding safety and other important instructions. The signal words and their
meanings are defined as follows. Please understand their meanings clearly before reading this
manual.

Signal word Meaning

Indicates an imminently hazardous situation that, if not avoided, will
DANGER
result in death or serious injury.
Indicates a potentially hazardous situation that, if not avoided, could
WARNING
result in death or serious injury.
Indicates a potentially hazardous situation that, if not avoided, may
CAUTION
result in minor or moderate injury.
NOTE Indicates a potentially hazardous situation that, if not avoided, may
result in property damage.

III
 Signal word Meaning
TIP Important information that helps you to use the system more effectively.

Hardcopy Manuals
• Operator’s Manual [Basic Volume]
Describes the basic functions and operations of the system, safety precautions, exam modes,
imaging modes, preset, maintenance and acoustic output, etc.
• Operator’s Manual [Advanced Volume]
• Operator’s Manual [Acoustic Power Data and Surface Temperature Data]
Contains data tables of acoustic output for transducers.
• Quick Reference Guide
Contains a quick reference guide for basic system operations.
The accompanying manuals may vary depending on the specific system you purchased. Please refer
to the packing list.

Software Interfaces in this Manual

Depending on the software version, preset settings and optional configuration, the actual interfaces
may be different from those in this manual.

Conventions
In this manual, the following conventions are used to describe the buttons on the control panel,
items in the menus, buttons in the dialog boxes and some basic operations:
• <Buttons>: angular brackets indicate buttons, knobs and other controls on the control panel or
on the keyboard.
• [Items in menu or buttons in dialog box]: square brackets indicate items in menus, on the soft
menu or buttons in dialog boxes.
• Click [Items or Buttons]: move the cursor to the item or button and press <Set> or use the soft
key corresponding to the soft menu.
• [Items in menu] > [Items in submenu]: select a submenu item following the path.

Notification of Adverse Events

As a health care provider, you may report the occurrence of certain events to SHENZHEN
MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., and possibly to the competent authority
of the Member state in which the user and / or patient is established.
These events, include device-related death and serious injury or illness. In addition, as part of our
Quality Assurance Program, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,
LTD. requests to be notified of device failures or malfunctions. This information is required to
ensure that SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. provides only
the highest quality products.

Operator’s Manuals
You may receive multi-language manuals on compact disc or paper. Please refer to the English
manual for the latest information and registration information.
The content of the operator manual, such as screens, menus or descriptions, may be different from
what you see in your system. The content varies depending on the software version, options and
configuration of the system.

IV
Contents

Intellectual Property Statement ................................................................................................ I

Responsibility on the Manufacturer Party ............................................................................... I
Warranty ................................................................................................................................. II
Exemptions ....................................................................................................................... II
Customer Service Department .......................................................................................... II
Important Information ............................................................................................................. II
About This Manual ................................................................................................................ III
Meaning of Signal Words ................................................................................................ III
Hardcopy Manuals ......................................................................................................... IV
Software Interfaces in this Manual ................................................................................. IV
Conventions .................................................................................................................... IV
Notification of Adverse Events ...................................................................................... IV
Operator’s Manuals ........................................................................................................ IV

1 Safety Precautions ...............................................................................................1 - 1

1.1 Meaning of Safety Symbols ........................................................................................... 1 - 1
1.2 Safety Precautions .......................................................................................................... 1 - 1
1.3 Latex Alert ..................................................................................................................... 1 - 7
2 System Overview .................................................................................................2 - 1
2.1 Intended Use .................................................................................................................. 2 - 1
2.2 Contraindication ............................................................................................................. 2 - 1
2.3 Safety Classifications ..................................................................................................... 2 - 1
2.4 Product Specifications ................................................................................................... 2 - 2
2.4.1 Power supply ....................................................................................................... 2 - 2
2.4.2 Environmental Conditions ................................................................................... 2 - 2
2.4.3 Dimensions and Weight ...................................................................................... 2 - 2
2.5 Product Differences ....................................................................................................... 2 - 2
2.6 System Configuration .................................................................................................... 2 - 3
2.6.1 Standard Configuration ....................................................................................... 2 - 3
2.6.2 Probes and Needle-guided Brackets Available ................................................... 2 - 4
2.6.3 Options ................................................................................................................ 2 - 4
2.6.4 Peripherals Supported .......................................................................................... 2 - 6
2.6.5 Parts that can be used within patient environment .............................................. 2 - 7
2.7 Introduction of Each Unit .............................................................................................. 2 - 8
2.8 U-Bank Overview .......................................................................................................... 2 - 9
2.8.1 Parts and Names ................................................................................................ 2 - 10
2.8.2 Installing the U-Bank ........................................................................................ 2 - 11
2.9 ECG Module Overview ............................................................................................... 2 - 12
2.10 Control Panel ............................................................................................................. 2 - 13
2.11 Exam Main Menu Screen ........................................................................................... 2 - 16
2.12 Monitor Display ......................................................................................................... 2 - 17
2.13 Basic Operations ........................................................................................................ 2 - 18

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Contents

2.13.1 Dialog Box ....................................................................................................... 2 - 18

2.13.2 Touch Screen ................................................................................................... 2 - 18
2.13.3 Voice Recognition ........................................................................................... 2 - 22
2.14 Warning Labels .......................................................................................................... 2 - 23
2.15 Symbols ...................................................................................................................... 2 - 23

3 System Preparation ............................................................................................. 3 - 1

3.1 Move/Position the System .............................................................................................. 3 - 1
3.2 Connecting the Power Cord ........................................................................................... 3 - 1
3.2.1 Connecting Power ................................................................................................ 3 - 1
3.2.2 Powered by Batteries ........................................................................................... 3 - 1
3.3 Power ON/OFF .............................................................................................................. 3 - 2
3.3.1 Check before Powering ON ................................................................................. 3 - 3
3.3.2 Power the System ON .......................................................................................... 3 - 3
3.3.3 Check the system after it is powered on .............................................................. 3 - 4
3.3.4 Power the System Off .......................................................................................... 3 - 5
3.3.5 Standby ................................................................................................................ 3 - 5
3.4 Monitor Brightness/Contrast Adjustment ...................................................................... 3 - 6
3.5 Connecting/Disconnecting a Probe ................................................................................ 3 - 6
3.5.1 Connecting a Probe .............................................................................................. 3 - 6
3.5.2 Disconnecting a probe ......................................................................................... 3 - 7
3.6 Connecting USB Devices ............................................................................................... 3 - 7
3.7 Connecting the Footswitch ............................................................................................. 3 - 8
3.8 Installing a Printer .......................................................................................................... 3 - 8
3.8.1 Connecting a Graph/Text Printer ......................................................................... 3 - 8
3.8.2 Connecting a Video Printer ................................................................................. 3 - 9
3.8.3 Connecting a Wireless Printer ........................................................................... 3 - 10
4 Setup ..................................................................................................................... 4 - 1
4.1 System Preset ................................................................................................................. 4 - 2
4.1.1 Region .................................................................................................................. 4 - 2
4.1.2 General ................................................................................................................. 4 - 2
4.1.3 Image Preset ......................................................................................................... 4 - 4
4.1.4 Application .......................................................................................................... 4 - 5
4.1.5 OB ........................................................................................................................ 4 - 7
4.1.6 Key Probe ............................................................................................................ 4 - 9
4.1.7 Key Configuration ............................................................................................. 4 - 10
4.1.8 Gesture ............................................................................................................... 4 - 11
4.1.9 Output ................................................................................................................ 4 - 11
4.1.10 Access Control ................................................................................................. 4 - 12
4.1.11 Scan Code Preset ............................................................................................. 4 - 16
4.2 Exam Mode Preset ....................................................................................................... 4 - 18
4.3 Measurement Preset ..................................................................................................... 4 - 19
4.3.1 General Measurement Preset ............................................................................. 4 - 19
4.3.2 Application Measurement Preset ....................................................................... 4 - 21
4.3.3 Report Preset ...................................................................................................... 4 - 26
4.4 Comment Preset ........................................................................................................... 4 - 27
4.4.1 Comment Configure .......................................................................................... 4 - 27
4.4.2 Comment Group Define .................................................................................... 4 - 28

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4.5 iWorks Preset ............................................................................................................... 4 - 28

4.5.1 Protocol Management ........................................................................................ 4 - 28
4.5.2 View Management ............................................................................................ 4 - 29
4.5.3 Create a New Protocol ....................................................................................... 4 - 29
4.6 Stress Echo Preset ........................................................................................................ 4 - 29
4.6.1 Protocol Edit ...................................................................................................... 4 - 29
4.6.2 Maintenance ...................................................................................................... 4 - 30
4.7 DICOM/HL7 ................................................................................................................ 4 - 31
4.7.1 DICOM Local Preset ......................................................................................... 4 - 31
4.7.2 DICOM Service Preset ...................................................................................... 4 - 32
4.8 Network Preset ............................................................................................................. 4 - 38
4.8.1 Network Settings ............................................................................................... 4 - 38
4.8.2 iStorage Preset ................................................................................................... 4 - 39
4.8.3 MedTouch/MedSight Preset .............................................................................. 4 - 40
4.8.4 Remote Maintenance ......................................................................................... 4 - 40
4.8.5 Q-Path Preset ..................................................................................................... 4 - 40
4.8.6 eGateway Preset ................................................................................................ 4 - 41
4.9 Print Preset ................................................................................................................... 4 - 43
4.9.1 Print Setting ....................................................................................................... 4 - 43
4.9.2 Image Settings ................................................................................................... 4 - 43
4.10 Maintenance ............................................................................................................... 4 - 43
4.10.1 Option .............................................................................................................. 4 - 44
4.10.2 Exporting Setup Data ...................................................................................... 4 - 44
4.10.3 Importing Setup Data ...................................................................................... 4 - 44
4.10.4 Probe Check .................................................................................................... 4 - 44
4.10.5 Other Settings .................................................................................................. 4 - 44
4.11 Security ...................................................................................................................... 4 - 45
4.11.1 Drive Encryption/Secure Data Wipe ............................................................... 4 - 45
4.11.2 Anti-Virus ........................................................................................................ 4 - 46
4.11.3 Transmission Encryption ................................................................................. 4 - 46
4.12 System Information .................................................................................................... 4 - 46

5 Exam Preparation ...............................................................................................5 - 1

5.1 Patient Information ........................................................................................................ 5 - 1
5.1.1 New Patient Information ..................................................................................... 5 - 1
5.1.2 Retrieve Patient Information ............................................................................... 5 - 2
5.2 Activate& Continue an Exam ........................................................................................ 5 - 3
5.2.1 Activate an Exam ................................................................................................ 5 - 3
5.2.2 Continue an Exam ............................................................................................... 5 - 3
5.3 Pause & End an Exam .................................................................................................... 5 - 4
5.3.1 Pause an Exam ..................................................................................................... 5 - 4
5.3.2 End an Exam ....................................................................................................... 5 - 4
6 Image Acquisition ................................................................................................6 - 1
6.1 B Mode ........................................................................................................................... 6 - 1
6.1.1 B-mode Image Scanning ..................................................................................... 6 - 1
6.1.2 B-mode Image Parameters .................................................................................. 6 - 1
6.2 Color Mode .................................................................................................................... 6 - 4
6.2.1 Color Mode Image Scanning ............................................................................... 6 - 4

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Contents

6.2.2 Color Mode Image Parameters ............................................................................ 6 - 5

6.3 Power Mode ................................................................................................................... 6 - 7
6.3.1 Power Mode Image Scanning .............................................................................. 6 - 7
6.3.2 Power Mode Image Parameters ........................................................................... 6 - 7
6.4 M Mode ......................................................................................................................... 6 - 7
6.4.1 M Mode Image Scanning ..................................................................................... 6 - 7
6.4.2 M Mode Image Parameters .................................................................................. 6 - 8
6.5 Color M Mode (CM) ...................................................................................................... 6 - 8
6.5.1 CM Image Scanning ............................................................................................ 6 - 9
6.5.2 CM Image Parameters ......................................................................................... 6 - 9
6.6 Anatomical M Mode ...................................................................................................... 6 - 9
6.6.1 Linear Anatomical M (Free Xros M) ................................................................... 6 - 9
6.6.2 Free Xros CM (Curved Anatomical M-Mode) .................................................. 6 - 10
6.6.3 Anatomical M Mode Parameters ....................................................................... 6 - 11
6.7 PW/CW Mode .............................................................................................................. 6 - 11
6.7.1 PW/CW Mode Image Scanning ......................................................................... 6 - 11
6.7.2 PW/CW Mode Image Parameters ...................................................................... 6 - 11
6.8 TDI ............................................................................................................................... 6 - 13
6.8.1 TDI Mode Image Scanning ............................................................................... 6 - 14
6.8.2 TDI Mode Image Parameters ............................................................................. 6 - 14
6.8.3 TDI Quantitative Analysis ................................................................................. 6 - 14
6.9 iScape ........................................................................................................................... 6 - 17
6.9.1 Basic Procedures for iScape Imaging ................................................................ 6 - 18
6.9.2 Image Review .................................................................................................... 6 - 19
6.9.3 Evaluate image quality ...................................................................................... 6 - 19
6.9.4 Cine Review ....................................................................................................... 6 - 19
6.10 R-VQS ........................................................................................................................ 6 - 20
6.11 Smart B-line ............................................................................................................... 6 - 21
6.11.1 Basic Procedures for Smart B-line .................................................................. 6 - 22
6.11.2 Overview .......................................................................................................... 6 - 23
6.12 Smart VTI ................................................................................................................... 6 - 23
6.13 Smart IVC .................................................................................................................. 6 - 25
6.14 RIMT (Real-time Intima-Media Thickness) .............................................................. 6 - 27
6.15 Tissue Tracking Quantitative Analysis ...................................................................... 6 - 28
6.15.1 Basic Procedures for Tissue Tracking QA ...................................................... 6 - 28
6.15.2 Screen Display of Tissue Tracking QA ........................................................... 6 - 29
6.15.3 Select Image and Cardiac Cycle ...................................................................... 6 - 30
6.15.4 Myocardial Boundary Tracing ......................................................................... 6 - 30
6.15.5 Basic Operations of TTQA .............................................................................. 6 - 31
6.15.6 Bulleye ............................................................................................................. 6 - 33
6.15.7 Measurement/Comment ................................................................................... 6 - 33
6.15.8 Data Export ...................................................................................................... 6 - 33
6.16 Auto GA ..................................................................................................................... 6 - 33
6.17 Auto DFR ................................................................................................................... 6 - 34
6.18 Smart FHR OB1 ......................................................................................................... 6 - 34
6.19 AutoEF ....................................................................................................................... 6 - 35
6.20 Smart Bladder ............................................................................................................. 6 - 36
6.21 iWorks (Auto Workflow Protocol) ............................................................................ 6 - 37

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6.21.1 Screen Display ................................................................................................. 6 - 38

6.21.2 View Operation ............................................................................................... 6 - 38
6.21.3 Manual Examination ....................................................................................... 6 - 39
6.21.4 Insert ................................................................................................................ 6 - 39
6.22 Quickly Saving Image Settings .................................................................................. 6 - 39

7 Smart 3D ..............................................................................................................7 - 1
7.1 Overview ........................................................................................................................ 7 - 1
7.1.1 Terms ................................................................................................................... 7 - 1
7.1.2 ROI and VOI ....................................................................................................... 7 - 2
7.1.3 Render Mode ....................................................................................................... 7 - 3
7.1.4 MPR .................................................................................................................... 7 - 3
7.1.5 Wire cage ............................................................................................................. 7 - 4
7.2 Note before Use ............................................................................................................. 7 - 4
7.2.1 Smart 3D Image Acquisition ............................................................................... 7 - 6
7.2.2 Smart 3D Image Viewing .................................................................................... 7 - 7

8 Strain Elastography ............................................................................................8 - 1

8.1 Basic Procedure for Strain Elastography ....................................................................... 8 - 1
8.2 Image Parameters ........................................................................................................... 8 - 2
8.3 Mass Measurement ........................................................................................................ 8 - 2
9 Contrast Imaging .................................................................................................9 - 1
9.1 Basic Procedures for Contrast Imaging ......................................................................... 9 - 1
9.2 Left Ventricular Opacification ....................................................................................... 9 - 2
9.3 Low MI Contrast Imaging ............................................................................................. 9 - 2
9.4 Image Parameters ........................................................................................................... 9 - 2
9.5 Image Saving ................................................................................................................. 9 - 4
9.6 Micro Flow Enhancement .............................................................................................. 9 - 4
9.7 Contrast Imaging QA ..................................................................................................... 9 - 4
10 Physiological Unit Signal ................................................................................10 - 1
10.1 ECG ............................................................................................................................ 10 - 1
10.2 Respiratory Wave ....................................................................................................... 10 - 3
10.3 ECG Review .............................................................................................................. 10 - 3
10.3.1 Review Principle ............................................................................................. 10 - 3
10.3.2 Linked Review of Waveforms, M/D Images and 2D Images ......................... 10 - 3
10.4 Parameter Description ................................................................................................ 10 - 4
11 Stress Echo ....................................................................................................... 11 - 1
11.1 Stress Echo Acquisition Procedure ............................................................................ 11 - 1
11.2 Selecting Preferred Stress Echo Loops (Select Mode) .............................................. 11 - 2
11.3 Review/WMS Mode .................................................................................................. 11 - 4
11.3.1 Enter review mode ........................................................................................... 11 - 4
11.3.2 Wall Motion Scoring ....................................................................................... 11 - 5
11.4 Saving Stress Echo Data ............................................................................................ 11 - 6
11.5 Exiting the Stress Echo Feature ................................................................................. 11 - 6
11.6 Measurement and Report ........................................................................................... 11 - 6
12 Display & Cine Review ...................................................................................12 - 1

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12.1 Splitting Display ......................................................................................................... 12 - 1

12.2 Image Magnification .................................................................................................. 12 - 1
12.2.1 Spot Zoom ....................................................................................................... 12 - 1
12.2.2 Pan Zoom ......................................................................................................... 12 - 1
12.2.3 iZoom (Full-screen Zooming) ......................................................................... 12 - 2
12.3 Freeze/Unfreeze the Image. ........................................................................................ 12 - 2
12.3.1 Imaging Mode Switching When Frozen .......................................................... 12 - 2
12.4 Cine Review ............................................................................................................... 12 - 2
12.4.1 Entering/Exiting Cine Review ......................................................................... 12 - 3
12.4.2 2D Cine Review ............................................................................................... 12 - 3
12.4.3 Cine Review in M/PW/CW/TVD Mode .......................................................... 12 - 4
12.4.4 Linked Cine Review ........................................................................................ 12 - 5
12.5 Image Compare .......................................................................................................... 12 - 5
12.5.1 Image Compare in Review Mode .................................................................... 12 - 5
12.5.2 Frame Compare ............................................................................................... 12 - 6
12.6 Cine Saving ................................................................................................................ 12 - 6
12.6.1 Live Capture .................................................................................................... 12 - 6
12.6.2 Frozen image storage ....................................................................................... 12 - 7
12.7 Setting Cine Length .................................................................................................... 12 - 7
12.7.1 Live capture ..................................................................................................... 12 - 7
12.7.2 Freeze storage setting ...................................................................................... 12 - 7
13 Measurement, Comments and Body Mark ................................................... 13 - 1
13.1 Measurement .............................................................................................................. 13 - 1
13.2 Comments ................................................................................................................... 13 - 3
13.2.1 Adding Comments ........................................................................................... 13 - 3
13.2.2 Moving Comments .......................................................................................... 13 - 4
13.2.3 Editing Comments ........................................................................................... 13 - 5
13.2.4 Deleting Comments ......................................................................................... 13 - 5
13.2.5 Setting the Start Position ................................................................................. 13 - 6
13.3 Body Mark .................................................................................................................. 13 - 6
13.3.1 Adding Body Mark .......................................................................................... 13 - 6
13.3.2 Moving Body Marks ........................................................................................ 13 - 6
13.3.3 Deleting Body Marks ....................................................................................... 13 - 7

14 Patient Data Management .............................................................................. 14 - 1

14.1 Image File Management ............................................................................................. 14 - 1
14.1.1 Storage Media .................................................................................................. 14 - 1
14.1.2 Image File Formats .......................................................................................... 14 - 1
14.1.3 Image Storage Setting ...................................................................................... 14 - 2
14.1.4 Quickly Saving Images to the System ............................................................. 14 - 2
14.1.5 Saving Images to USB Flash Drive ................................................................. 14 - 2
14.1.6 Exporting Cine File to USB Flash Drive ......................................................... 14 - 2
14.1.7 Auxiliary Output Function ............................................................................... 14 - 3
14.1.8 Thumbnails ...................................................................................................... 14 - 3
14.1.9 Image Review and Analysis ............................................................................ 14 - 3
14.1.10 Sending Image File ........................................................................................ 14 - 4
14.2 Report Management ................................................................................................... 14 - 5
14.2.1 Report storage .................................................................................................. 14 - 5

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14.2.2 Importing, exporting and sending a report ...................................................... 14 - 5

14.3 Patient Data Management (iStation) .......................................................................... 14 - 5
14.3.1 Searching a Patient .......................................................................................... 14 - 6
14.3.2 Patient Data View & Management .................................................................. 14 - 6
14.4 Recycle bin ................................................................................................................. 14 - 7
14.5 iStorage ...................................................................................................................... 14 - 8
14.6 Print ............................................................................................................................ 14 - 8
14.6.1 Image Print ...................................................................................................... 14 - 8
14.6.2 Report Printing ................................................................................................ 14 - 8
14.7 Back up Files using the DVD Drive .......................................................................... 14 - 8
14.8 Patient Task Management .......................................................................................... 14 - 9
14.9 V-Access .................................................................................................................. 14 - 10
14.10 Q-Path .................................................................................................................... 14 - 10
15 DICOM/HL7 ....................................................................................................15 - 1
15.1 DICOM Storage ......................................................................................................... 15 - 1
15.1.1 Send images on iStation/Review/main screens ............................................... 15 - 1
15.1.2 To send images using a shortcut key ............................................................... 15 - 2
15.1.3 To send images to storage after an exam ends ................................................ 15 - 2
15.1.4 Encapsulate PDF ............................................................................................. 15 - 2
15.1.5 Unload DCM file ............................................................................................. 15 - 2
15.2 DICOM Print ............................................................................................................. 15 - 2
15.2.1 Print images on iStation/Review/Main screen ................................................ 15 - 2
15.2.2 To send images to DICOM Print after an exam ends ...................................... 15 - 3
15.3 Worklist ...................................................................................................................... 15 - 3
15.4 MPPS ......................................................................................................................... 15 - 4
15.5 Storage Commitment ................................................................................................. 15 - 4
15.5.1 Storage commitment after sending images on the iStation screen .................. 15 - 5
15.5.2 To send storage commitment automatically after an exam ends ..................... 15 - 5
15.6 Query/Retrieve ........................................................................................................... 15 - 5
15.7 DICOM Media Storage (DICOMDIR Review) ......................................................... 15 - 6
15.7.1 Media Storage .................................................................................................. 15 - 6
15.7.2 Media review ................................................................................................... 15 - 6
15.7.3 Data Restore .................................................................................................... 15 - 7
15.8 Structured Report ....................................................................................................... 15 - 7
16 Probes and Biopsy ...........................................................................................16 - 1
16.1 Probes ......................................................................................................................... 16 - 1
16.1.1 Probe Functions by Part .................................................................................. 16 - 3
16.1.2 Orientation of the Ultrasound Image and the Probe Head .............................. 16 - 4
16.1.3 Procedures for Operating ................................................................................. 16 - 5
16.1.4 Wearing the Probe Sheath ............................................................................... 16 - 7
16.1.5 Probes Cleaning and Disinfection/Sterilization ............................................ 16 - 10
16.1.6 Cleaning the probe cable and connector ........................................................ 16 - 14
16.1.7 Probe Environmental Conditions .................................................................. 16 - 15
16.1.8 Storage and Transportation ........................................................................... 16 - 16
16.2 Biopsy Guide ........................................................................................................... 16 - 17
16.2.1 Needle-guided Brackets Available ................................................................ 16 - 19
16.2.2 Needle-Guided Bracket Inspection and Installation ...................................... 16 - 20

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16.2.3 Verifying the Biopsy Guide Line .................................................................. 16 - 41

16.2.4 Starting the biopsy procedure ........................................................................ 16 - 42
16.2.5 Clean and Sterilize the Needle-Guided Bracket ............................................ 16 - 42
16.2.6 Storage and Transportation ............................................................................ 16 - 45
16.2.7 Disposal ......................................................................................................... 16 - 45
16.3 Middle Line .............................................................................................................. 16 - 45
16.4 eSpacial Navi ............................................................................................................ 16 - 46
16.4.1 Interface ......................................................................................................... 16 - 47
16.4.2 Preset .............................................................................................................. 16 - 48
16.4.3 Preparation Before Needle Guidance ............................................................ 16 - 49
16.4.4 Procedure ....................................................................................................... 16 - 50
16.4.5 Magnetizer Cleaning and Disinfection .......................................................... 16 - 50
16.4.6 Storage and Transportation ............................................................................ 16 - 52
16.4.7 Disposal ......................................................................................................... 16 - 52

17 DVR Recording ............................................................................................... 17 - 1

17.1 Start Recording ........................................................................................................... 17 - 1
17.2 Send Image ................................................................................................................. 17 - 1
17.3 DVR Video Replay .................................................................................................... 17 - 2
17.3.1 Replay on PC ................................................................................................... 17 - 2
17.3.2 Replay on the ultrasound system ..................................................................... 17 - 2
18 System Maintenance ....................................................................................... 18 - 1
18.1 Daily Maintenance ..................................................................................................... 18 - 1
18.1.1 Cleaning the System ........................................................................................ 18 - 1
18.1.2 Disinfecting the Main Unit .............................................................................. 18 - 4
18.1.3 Cleaning the peripherals .................................................................................. 18 - 4
18.1.4 Checking the Probe .......................................................................................... 18 - 5
18.1.5 Checking the Power Cable and Plug ............................................................... 18 - 5
18.1.6 Checking Appearance ...................................................................................... 18 - 5
18.1.7 System Hard Drive Backup ............................................................................. 18 - 5
18.2 Troubleshooting ......................................................................................................... 18 - 5

A Barcode Reader ................................................................................................. A - 1

A.1 1-D Barcode Reader ..................................................................................................... A - 1
A.1.1 Setting Up the Reader (Take LS2208 as an example) ....................................... A - 2
A.1.2 Setting ................................................................................................................ A - 2
A.1.3 Scanning in Hand-Held Mode ........................................................................... A - 4
A.1.4 Scanning in Hands-Free Mode .......................................................................... A - 5
A.2 2D Barcode Reader (Take DS4308 as an example) ..................................................... A - 7
A.2.1 Overview ............................................................................................................ A - 7
A.2.2 Setting Up the Digital Imager Reader ................................................................ A - 8
A.2.3 Setting ................................................................................................................ A - 8
A.2.4 Scanning in Hand-Held Mode ......................................................................... A - 10
A.3 Maintenance ............................................................................................................... A - 12
A.4 Parameter Defaults ..................................................................................................... A - 12

B Trolley and Accessories ..................................................................................... B - 1

B.1 Accessories ................................................................................................................... B - 1
B.2 Introduction of Each Unit ............................................................................................. B - 2

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 Contents

C Electrical Safety Inspection ..............................................................................C - 1

C.1 Power Cord Plug ...........................................................................................................C - 1
C.1.1 The Power Plug ...................................................................................................C - 1
C.2 Device Enclosure and Accessories ................................................................................C - 2
C.2.1 Visual Inspection ................................................................................................C - 2
C.2.2 Contextual Inspection .........................................................................................C - 2
C.3 Device Labeling ............................................................................................................C - 2
C.4 Protective Earth Resistance ...........................................................................................C - 2
C.5 Earth Leakage Test ........................................................................................................C - 2
C.6 Enclosure Leakage Test ................................................................................................C - 3
C.7 Patient Leakage Current ................................................................................................C - 3
C.8 Mains on Applied Part Leakage ....................................................................................C - 4
C.9 Patient Auxiliary Current ..............................................................................................C - 4
D Wireless LAN .....................................................................................................D - 1
D.1 Use the Wireless feature .............................................................................................. D - 1
D.2 IP Configure ................................................................................................................. D - 2
D.3 EAP Network ............................................................................................................... D - 2
E iScanHelper ........................................................................................................ E - 1
E.1 Use iScanHelper for Reference .....................................................................................E - 1
E.2 Use iScanHelper for Learning or Training ....................................................................E - 1
E.3 Basic Screen and Operation ...........................................................................................E - 2
E.3.1 View Selecting Area ...........................................................................................E - 2
E.3.2 Single/quad-window Display ..............................................................................E - 2
F iVision .................................................................................................................. F - 1
F.1 Demonstration item ....................................................................................................... F - 1
F.2 Demonstration catalog ................................................................................................... F - 1
F.2.1 Demo Catalog ...................................................................................................... F - 1
F.2.2 Customize Catalog .............................................................................................. F - 1
F.3 Copy the file .................................................................................................................. F - 2
F.4 Demonstration mode ...................................................................................................... F - 2
F.5 Option of Demo ............................................................................................................. F - 2
G List of Vocal Commands ...................................................................................G - 1
H Acoustic Output .................................................................................................H - 1
H.1 Concerns with Bioeffects ............................................................................................. H - 1
H.2 Prudent Use Statement ................................................................................................. H - 1
H.3 ALARA Principle (As Low As Reasonably Achievable) ............................................ H - 1
H.4 MI/TI Explanation ........................................................................................................ H - 2
H.4.1 Basic Knowledge of MI and TI ......................................................................... H - 2
H.4.2 MI/TI Display .................................................................................................... H - 3
H.5 Acoustic Power Setting ................................................................................................ H - 3
H.6 Acoustic Power Control ............................................................................................... H - 4
H.7 Acoustic Output ........................................................................................................... H - 4
H.7.1 Derated Ultrasonic Output Parameters .............................................................. H - 4
H.7.2 Limits of Acoustic Output ................................................................................. H - 5

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H.7.3 Differences between Actual and Displayed MI and TI ..................................... H - 5

H.8 Measurement Uncertainty ............................................................................................ H - 6
H.9 References for Acoustic Power and Safety .................................................................. H - 6
I EMC Guidance and Manufacturer’s Declaration ............................................ I - 1
J Indications for Use .............................................................................................. J - 1

x Operator’s Manual
1 Safety Precautions

1.1 Meaning of Safety Symbols

Symbol Description
Type-BF applied part
The ultrasound probes connected to this system are type-BF applied parts.
The ECG leads within this system is type-BF applied part.
Caution!

General warning sign.

Patient injury or tissue damage from ultrasonic radiation. The ALARA

principle must be practiced when operating the ultrasound system.

1.2 Safety Precautions

Please observe the following precautions to ensure patient and operator’s safety when using this
system.

CAUTION
U.S.A. Federal Law restricts this device to sale by or on the order of a
physician.

DANGER
Do not operate this system and probes in an atmosphere containing flammable
gases or liquids such as anesthetic gases, hydrogen, and ethanol, because
there is danger of explosion.

WARNING
• Do not connect the three-wire cable of the system with a two-wire plug
without protective grounding; otherwise, electric shock may result.
• Do connect the power plug of this system to wall receptacles that meet the
ratings indicated on the rating nameplate. If adapters or multi-functional

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1 Safety Precautions

receptacles are used, it may cause the leakage current to exceed the
safety requirement.
• In the environment that patient is 1.5 meters around, connect peripherals to
the auxiliary power outlet, or power the peripherals by auxiliary output
cable or isolation transformer complied with IEC60601-1 or the power input
of the same safety level.
• DO NOT use power supply of different phases to power peripherals, like
power supply of air-conditioning.
• When using peripherals not powered by the auxiliary output of the
ultrasound system, or using peripherals other than permitted by Mindray,
make sure the overall leakage current of peripherals and the ultrasound
system meets the requirement of the local medical device electrical
regulation (like enclosure leakage current should be no more than 500 uA
of IEC60601-1), and the responsibility is held by the user.
• Connect the grounding conductor before turning ON the system.
Disconnect the grounding cable after turning OFF the system. Otherwise,
electric shock may result.
• For the connection of power and grounding, follow the appropriate
procedures described in this operator's manual. Otherwise, there is risk of
electric shock. Do not connect the grounding cable to a gas pipe or water
pipe; otherwise, improper grounding may result or a gas explosion may
occur.
• Before cleaning the system, disconnect the power cord from the outlet.
System failure and electric shock may result.
• This system is not water-proof designed. Do Not use this system in any
place where water or any liquid leakage may occur. If any water is sprayed
on or into the system, electric shock may result or the system may be
damaged. If water is accidentally sprayed on or into the system, contact
Mindray Customer Service Department or sales representative.
• DO NOT use a probe that has a damaged, scratched surface, or exposed
wiring of any kind. Immediately stop using the probe and contact Mindray
Customer Service Department or sales representative. There is risk of
electric shock if using a damaged or scratched transducer.
• Do not allow the patient to contact the live parts of the ultrasound system or
other devices, e.g. signal I/O ports. Electric shock may occur.
• Do not use an aftermarket probe other than those specified by Mindray.
The probes may damage the system causing a profound failure, e.g. a fire
in the worst case.
• Do not subject the transducers to knocks or drops. Use of a defective
transducer may cause an electric shock.
• Do not open the covers and front panel of the system. Short circuit or
electric shock may result when the system hardware is exposed and
powered on.
• Do not use the system with the patient when the system is being serviced
or maintained.

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 1 Safety Precautions

• Do not use this system when any digital device such as a high-frequency
electrotome, high-frequency therapeutic device or defibrillator is applied
already. Otherwise, there is a risk of electric shock to the patient.
• Only use the ECG leads provided with the physiology module; otherwise,
electric shock may be resulted.
• When moving the system, you should first fold the LCD display, disconnect
the system from other devices (including probes) and disconnect the
system from the power supply.
• The auxiliary power output outlet in the system is used to supply power for
the recommended peripheral devices. Do not connect other devices to the
outlet, otherwise, the rated output power may be exceeded and failure may
be resulted.
• Accessory equipment (analog or digital) connected to the ultrasound
system must comply with the relevant IEC standards (e.g., IEC 60950
information technology equipment safety standard and IEC 60601-1
medical equipment standard). Furthermore, all configurations must comply
with the standard IEC60601-1. It is the responsibility of the person, who
connects additional equipment to the signal input or output ports and
configures a medical system, to verify that the system complies with the
requirements of IEC60601-1. If you have any questions regarding these
requirements, consult your vendor.
• Prolonged and repeated use of keyboards may result in hand or arm nerve
disorders for some individuals. Observe the local safety or health
regulations concerning the use of keyboards.
• When using intra-cavity transducers, do not activate the transducer outside
the patient’s body.
• It is not allowed for the operator to have contact with other patients and the
electronic parts (such as the input/output terminal of the signal) of other
devices that are connected to the system. Otherwise, it may produce the
electrical shock to the patient.
• The operator SHOULD NOT touch Signal Input Ports/Signal Output Ports
and the patient at the same time.
• DO NOT block the cooling vent of the system.
• Do not expose the device to a magnetic resonance (MR) environment.

CAUTION
• Precautions concerning clinical examination techniques:
– This system must be used only by qualified medical professionals.
– This operator’s manual does not describe clinical examination
techniques. The clinician should select the proper examination
techniques based on specialized training and clinical experience.
• Malfunctions due to radio wave:

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1 Safety Precautions

– If a radio wave emitting device is used in the proximity of this system, it

may interfere with operations. Do not use or take any devices
transmitting RF signals (such as cellular phones, transceivers and radio
controlled products) in the room placing the system.
– If a person brings a device that generates radio waves near the
system, ask him/her to immediately turn OFF the device.
• Precautions concerning movement of the system:
– When you place the system on the mobile trolley and move them
together, you must secure all objects on the mobile trolley to prevent
them from falling. Otherwise you should separate the system from the
mobile trolley and move them individually.
When you have to move the system with the mobile trolley upward or
downward the stairs, you must separate them first and then move them
individually.
– Object placed on the monitor may fall and injure an individual when
moving.
– Confirm that there is no peripheral device connected to the system
before moving the system. Otherwise, peripheral device may fall and
injure an individual.
• If the circuit protector is tripped, it indicates that the system or a peripheral
device was improperly shut down and the system is unstable. You cannot
repair the system under this circumstance and must call the Mindray
Customer Service Department or sales representative.
• There is no risk of high-temperature burns during normal ultrasound
examinations. It is possible for the surface temperature of the transducer to
exceed the body temperature of a patient due to environmental
temperature and exam type combinations. Do not apply the transducer to
the same region on the patient for a long time. Apply the transducer only for
a period of time required for the purpose of diagnosis.
• Do not use the system to examine a fetus for a long period of time.
• Except accessories that have been stated as sterile, the system and its
accessories are not disinfected or sterilized prior to delivery. The operator
is responsible for the cleaning and disinfection of probes and sterilization of
biopsy brackets according to the manuals, prior to the use. All items must
be thoroughly processed to completely remove harmful residual chemicals,
which will not only harmful to the human body, but also damage the
accessory.
• It is necessary to end the current scan that is in progress and clear the
current Patient Information field. Otherwise, new patient data may be
combined with the previous patient data.
• Do not connect or disconnect the system’s power cord or its accessories
(e.g., a printer or a recorder) without turning OFF the system power first.
This may damage the system and its accessories or cause electric shock.
• If the system is powered off improperly during operation, it may result in
data damage of the system’s hard disk or system failure.

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 1 Safety Precautions

• Do not use a USB memory device (e.g., a USB flash drive, removable hard
disk) which has unsafe data. Otherwise, system damage may result.
• It is recommended to only use the video devices specified in this manual.
• Do not use gel, disinfectant, probes, probe sheath or needle-guided
brackets that are not compatible with the system.
• The applied contrast agency should be compliant with the relevant local
regulations.
• Read the Acoustic Output Principle in the operation manual carefully before
operating this system on clinical examination.
• The cover contains natural rubber that can cause allergic reactions in some
individuals.
• Please use the ultrasound gel compliant with the relevant local regulations.
• DO NOT expose the system to excessive vibration through transportation.
Mechanical damage may result.
• Always keep the system dry. Avoid transporting this system quickly from a
cold place to a warm place; otherwise condensation or water droplets may
form allowing a short circuit and possible electric shock.

NOTE:
• DO NOT use the system in the vicinity of strong electromagnetic field (such as a transformer),
which may affect the performance of the system.
• Do not use the system in the vicinity of high-frequency radiation source (e.g. cellular phones),
which may affect the performance of the system or even lead to failure.
• When using or placing the system, keep the system horizontal to avoid imbalance.
• To avoid damaging the system, do not use it in following environment:
– Locations exposed to direct sunlight.
– Locations subject to sudden changes in environmental temperature.
– Dusty locations.
– Locations subject to vibration.
– Locations near heat generators.
– Locations with high humidity.
• Turn ON the system only after the power has been turned OFF for a while. If the system is
turned ON immediately after being turned OFF, the system may not be rebooted properly and
could malfunction.
• Use the Freeze key to freeze an image or turn off the power of the system before connecting or
disconnecting a probe.
• Remove the ultrasound gel from the face of the transducer when the examination is completed.
Water in the gel may enter the acoustic lens and adversely affect the performance and safety of
the transducer.
• You should properly back up the system to a secure external storage media, including system
configuration, settings and patient data. Data stored to the system’s hard drive may be lost due
to system failure, improper operation or accident.
• Do not apply external force to the control panel. Otherwise, the system may be damaged.

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1 Safety Precautions

• If the system is used in a small room, the room temperature may rise. Please provide proper
ventilation and free air exchange.
• To dispose of the system or any part, contact Mindray Customer Service Department or sales
representative. Mindray is not responsible for any system content or accessories that have been
discarded improperly.
• Electrical and mechanical performance may be degraded due to long usage (such as current
leakage or distortion and abrasion); the image sensitivity and precision may become worse too.
To ensure optimal system operations, it is recommended that you maintain the system under a
Mindray service agreement.
• Refer replacing job to Mindray service engineers or engineers authorized by Mindray only.
• Do not turn OFF the power supply of the system during printing, file storage or invoking other
system operations. An interrupted process may not be completed, and can become lost or
corrupted.
• Ensure that the current exam date and time are the same as the system date and time.
• Use detachable power supply cord as mains power breaking device. DO NOT set equipment in
place where difficult for disconnection of detachable power supply cord.

Please read the following precautions carefully to ensure the safety of the patient and the operator
when using the probes.

WARNING
• The ultrasound probe is only for use with the specified ultrasound
diagnostic system.
• The ultrasound probe must be used only by qualified professionals.
• Confirm that the transducer and probe cable are normal before and after
each examination. A defective probe may cause electric shock to the
patient.
• Do not subject the probe to shock. A defective probe may cause electric
shock to the patient.
• Do not disassemble the probe to avoid the possibility of electric shock.
• Never immerse the probe connector into liquids such as water or
disinfectant because the connector is not waterproof. Immersion may
cause electric shock or malfunction.
• A transducer sheath must be installed over the transducer before
performing examination.
• When using a probe, pay attention to the status of the ultrasound image.
Do not use the probe to perform image acquisition when the image is
frozen.

CAUTION
• When using the probe, wear sterile gloves to prevent infection.
• Be sure to use sterile ultrasound gel. Please use the ultrasound gel com-
pliant with the relevant local regulations. And manage the ultrasound gel
properly to ensure that it does not become a source of infection.

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 1 Safety Precautions

• In normal diagnostic ultrasound mode, there is no danger of a normal-

temperature burn; however, keeping the probe on the same region of the
patient for a long time may cause such a burn.
• Do not use the carrying case for storing the transducer. If the carrying case
is used for storage, it may become a source of infection.
• It is required to practice ALARA when operating ultrasound system.
Minimize the acoustic power without compromising the quality of images.
• The probe and accessories supplied with it are not delivered disinfected or
sterilized. Sterilization (or high-level disinfect) before use is required.
• Disposable components should be packaged sterile and for single-use
only. Do not use if integrity of packaging violated or if expiration date has
passed. Please use the disposable components compliant with the relevant
local regulations.
• Please use the disinfection or sterilization solution recommended in this
operator's manual; otherwise Mindray will not be liable for damage caused
by other solutions. If you have any questions, please contact Mindray
Customer Service Department or sales representative.
• Do not use pre-lubricated condoms as a sheath. Lubricant may not be
compatible with the probe material and damage may result.
• The damage of the transducer may be caused by the contact of improper
gel or cleaner:
– DO NOT dip the transducer in the strong polar solution of ethanol,
chloride of lime, ammonium chloride, acetone and formaldehyde.
– DO NOT contact the transducer with solution or ultrasound gel
containing oily medium such as mineral oil or lanoline.

NOTE:
• Read the following precautions to prevent the probe from malfunction:
– Before connecting or disconnecting the probe, freeze or turn off the diagnostic ultrasound
system.
– Clean and disinfect the probe before and after each examination.
– After the examination, wipe off the ultrasound gel thoroughly. Otherwise, the ultrasound
gel may solidify and the image quality would be degraded.
• Repeated disinfection will eventually damage the probe, please check the probe performance
periodically.

1.3 Latex Alert

When choosing a probe sheath, it is recommended that you directly contact CIVCO for obtaining
information regarding probe sheaths, pricing, samples and local distribution.
For CIVCO information, please contact the following:
CIVCO Medical Instruments
Tel: 1-800-445-6741

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1 Safety Precautions

www.civco.com

WARNING
Allergic reactions in patients sensitive to latex (natural rubber) may range from
mild skin reactions (irritation) to fatal anaphylactic shock, and may include
difficulty breathing (wheezing), dizziness, shock, swelling of the face, hives,
sneezing, or itching of the eyes (FDA Medical Alert on latex products, “Allergic
Reactions to Latex-containing Medical Devices”, issued on March 29, 1991).

1-8 Operator’s Manual

2 System Overview

2.1 Intended Use

NOTE:
The system is not intended for central cardiovascular or central nervous system use.

Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and
neonates.It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ(breast,
thyroid, testes), neonatal cephalic,adult cephalic,trans-rectal, trans-vaginal, musculo-
skeletal(conventional), musculo- skeletal(superficial), thoracic/pleural, cardiac adult, cardiac
pediatric, peripheral vessel and urology, intra-operative(abdominal, thoracic, and vascular) , trans-
esoph(Cardiac) exams.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined
mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic
Imaging, iScape, TDI, color M, Smart 3D, Strain Elastography, Contrast imaging (Contrast agent
for LVO), Contrast imaging (Contrast agent for Liver).

2.2 Contraindication
For FDA region: None.
For Canada region: Ophthalmic use is only permitted by probes with an ophthalmic indication.

2.3 Safety Classifications

• According to the type of protection against electric shock:
Class I equipment + internally powered equipment
• According to the degree of protection against electric shock:
Type-BF applied part
• According to the degree of protection against harmful ingress of water:
– The main unit is rated as IPX0
– The probes are rated as IPX7
– The foot switch (can be applied in the operating room) is rated as IPX8
– The power adapter is rated as IP22
• According to the disinfection and sterilization method(s) recommended by manufacturer:
Equipment with disinfection and sterilization method(s) recommended by manufacturer.
• According to the degree of safety of application in the presence of a FLAMMABLE
ANESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE
EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC
MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE

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2 System Overview

• According to the mode of operation:

Continuous operation
• According to the installation and use:
Portable equipment
Mobile equipment (when the system is installed on the mobile trolley)
• Does the equipment has any defibrillation-proof applied parts:
Non-defibrillation-proof applied part
• Permanently installed equipment or non-permanently installed equipment:
Non-permanently installed equipment

2.4 Product Specifications

NOTE:
The functions described in the operator’s manual may vary depending on the specific system
purchased.

2.4.1 Power supply

• Voltage: 100 V - 240 V AC
• Frequency: 50/60 Hz
• Power input: 2.0-1.0A; Trolley power input: 4.4-2.5A
• Battery voltage: 14.4 V

2.4.2 Environmental Conditions

• Operating conditions
– Ambient temperature: 0 °C ~ 40 °C
– Relative humidity: 20% ~ 85% (no condensation)
– Atmospheric pressure: 700 hPa ~ 1060 hPa
• Storage and transportation conditions
– Ambient temperature: -20 °C ~ 55 °C
– Relative humidity: 20% ~ 95% (no condensation)
– Atmospheric pressure: 700 hPa ~ 1060 hPa

WARNING
Do not use this system in conditions other than those specified.

2.4.3 Dimensions and Weight

• Dimensions (D×W×H, unit: mm): (322±5) × (364±5) × (44±3)
• Weight (including batteries): <4.0 kg

2.5 Product Differences

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 2 System Overview

Model Histogr Profile Color Double- Spline Parallel Cross Appearance

am Vel Dist length line
MX7 √ √ √ √ √ √ √ Blue
MX7T √ × √ √ √ √ √
Vaus7 × × √ √ √ √ √
Zeus √ √ × × √ √ √
ME7 √ √ √ √ √ × √
Anesus √ × √ √ √ × √
ME7
Anesus × × √ √ √ × √
ME7T
MX7P √ × × √ × √ √
MX7W √ √ × × × √ √
MX8 √ √ √ √ √ √ √ Gray
MX8T √ × √ √ √ √ √
Vaus8 × × √ √ √ √ √
ME8 × × × √ √ √ ×

NOTE:
• Histogram - measures and counts the gray distribution of ultrasonic echo signals within a
closed region.
• Profile - measures the gray distribution of ultrasonic echo signals on a line.
• Color Vel - measures the velocity of blood flow on the Color Mode image.
• Double-Dist - measures the lengths of line segments A and B perpendicular to each other.
• Spline length - measures the length of a curve on the image.
• Parallel line - measures the distance between every two line segments of five parallel line
segments, namely, four distances in total.
• Only MX7, MX7T, ME7, MX8 and ME8 are available in Canada.

2.6 System Configuration

2.6.1 Standard Configuration
• Main unit
• Power adapter
• Built-in batteries
• System software
• Travelling case
• Accessories
– Operator’s manuals
– User-defined label

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2 System Overview

– Cables

2.6.2 Probes and Needle-guided Brackets Available

Please see “16 Probes and Biopsy”.

2.6.3 Options

Item Remarks
Mobile Trolley Power supply, retractable cable
Power supply, without retractable cable
Without power supply, without retractable cable
ECG module /
Multilingual controls overlay /
Dust-proof cover /
WiFi module /
ECG cables ECG module should be configured
DC-IN cable ECG module should be configured
U-Bank (2 Batteries or 4 Batteries) /
Ultrasound gel /
Magnetizer package /
Main unit cover /
Display cover /
Special imaging iScape View /
Free Xros M /
Free Xros CM /
Tissue Doppler Imaging Cardiology Package should be configured.
TDI QA TDI should be configured.
CW /
Contrast imaging /
Contrast Imaging QA Contrast Imaging should be configured.
LVO Cardiology Package should be configured.
Low MI Contrast Cardiology Package should be configured.
Strain Elastography /
Stress Echo Cardiology Package should be configured.
Tissue Tracking QA Cardiology Package should be configured.
Smart 3D /

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 2 System Overview

Item Remarks
DICOM DICOM Basic DICOM Basic, including:
• Verify (SCU and SCP)
• Task management
• DICOM Storage
• DICOM Print
• DICOM Storage Commitment
• DICOM Media Storage (including DICOM DIR)
DICOM Worklist DICOM Basic should be configured.
DICOM MPPS
DICOM Query/Retrieve
DICOM OB/GYN SR
DICOM Vascular SR
DICOM Cardiac SR
DICOM Breast SR
DICOM Abdomen SR

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2 System Overview

Item Remarks
Application Abdomen/General /
packages Package
Obstetrics Package /
Smart OB Obstetrics package should be configured.
Smart NT Obstetrics package should be configured.
Gynecology Package /
Cardiology Package /
Small Parts Package /
Urology Package /
Vascular Package /
Pediatrics Package /
Nerve Package /
Emergency&Critical /
Package
RIMT Vascular Package should be configured.
AutoEF Cardiology Package should be configured.
R-VQS Vascular Package should be configured.
Smart B-line /
Smart VTI Cardiology Package should be configured.
Smart IVC /
CPP /
Smart FHR OB1 /
Smart Bladder /
Auto DFR /
Auto GA /
Others iWorks /
iNeedle /
eSpacial Navi /
iVocal /
McAfee /
DVR Module /

2.6.4 Peripherals Supported

Item Model
Black/ white video printer MITSUBISHI P95DW-N
(digital)

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 2 System Overview

Item Model
Black/ white video printer SONY UP-X898MD
(analog)
Digital color video printer SONY UP-D25MD
iVocal SAMSON XPD1 Headset
SAMSON XPD1 Presentation
PYLE PUSBMIC43
External DVD R/W drive DVDRW HP GP60NB60
Barcode reader DS4308
LS2208
JADAK HS-1M
JADAK HS-1R
Honeywell HH1800
Footswitch 971-SWNOM (2-pedals)
971-SWNOM (3-pedals)
FS-81-SP-2 (1-pedal)

2.6.5 Parts that can be used within patient environment

• The ultrasound system
• Video Printers

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2 System Overview

2.7 Introduction of Each Unit

Figure 2-1 Overview

2
3
4
5
6
7
8

10

11

12
13

No. Name Description

1. Display Displays the images and parameters during scanning.
2. Touch screen Screen-touching operator-system interface or control.
3. Power button/Power Used for turning on/ off the power.
indicator The indicator lights up when the system is powered on.
4. S-Video S-Video signal output. Used for separate video output, and
connecting projector, ultrasound workstation video capture card,
etc.
5. Network port Used for connecting router, ultrasound workstation, server, etc.
6. HDMI High definition multimedia interface. Used for connecting TV,
projector, ultrasound workstation video capture card, etc.‘
7. USB ports Used for connecting storage device such as USB disk, bar code
reader, printer, footswitch, DVD recorder, etc.

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 2 System Overview

No. Name Description

8. Secondary Display Displays battery capacity, AC power status and product model, etc.
NOTE:
The actual remaining time of the battery varies depending on
the actual operating modes.
9. Handle Used for carrying the system.
10. Control Panel Operator-system interface or control.
NOTE:
The buttons and knobs on the control panel may be different for
different product models. Please refer to the control panel of the
product for the actual buttons and knobs.
11. Probe port Connects a probe to the main unit; or connects a probe extend
module.
12. Probe locking lever Locks or unlocks the probe connected with the main unit:
• : locked symbol.
• : unlocked symbol.
13. Power input port Connects the power adapter.

2.8 U-Bank Overview

WARNING
• Only technical professionals from Mindray or engineers authorized by
Mindray after training can perform batteries in the U-Bank installation and
uninstallation.
• If you need to change the batteries in the U-Bank, please contact your
sales representative.

Specifications are as follows:

• Voltage: 19V DC
• Capacity: 26400 mAh or 13200 mAh
Under power off or standby status, charging time of the battery from capacity 0 to 100% takes
about 5 hours.
U-Bank environmental conditions are as follows:
• Operating conditions
– Ambient temperature: 0 °C ~ 35 °C
– Relative humidity: 20% ~ 85% (no condensation)
– Atmospheric pressure: 700 hPa ~ 1060 hPa
• Storage and transportation conditions
– Ambient temperature: -20 °C ~ 55 °C
– Relative humidity: 20% ~ 95% (no condensation)
– Atmospheric pressure: 700 hPa ~ 1060 hPa

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 2 System Overview

2.8.1 Parts and Names

Figure 2-2 U-Bank

1 2 3 4 5 6

L1 L2 L3 L4 L5

No. Name Description

1. Power connector Connects to the power input port of the system.
2. Tabs Used for fixing the U-Bank to the system.
3. Charging input port Connects the power adapter.
4. Capacity indicators (L1~L5) Indicates the power of the U-Bank.
• The L1-L5 indicators remain on: fully charged or >
80%.
• The L1-L4 indicators remain on: 60% < remaining
capacity ≤ 80%.
• The L1-L3 indicators remain on: 40% < remaining
capacity ≤ 60%.
• The L1-L2 indicators remain on: 20% < remaining
capacity ≤ 40%
• The L1 indicator remains on: 10% < remaining
capacity ≤ 20%
• The L1 indicator blinks: remaining capacity ≤ 10%

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 2 System Overview

No. Name Description

5. Baterry status indicator Indicates the charge/discharge status of the U-Bank.
• When the battery is charging:
Not fully charged: the indicator lights in orange.
Fully charged: the indicator lights in green.
• When the battery is discharging:
The remaining capacity ≥ 20%: the indicator lights in
green.
The remaining capacity < 20%: the indicator blinks in
orange.
The remaining capacity ≤ 5%: the indicator blinks in
orange quickly.

NOTE:
When the U-Bank is charging or when you are pressing
the power button, the indicator blinks in orange for 5s,
and other indicators remain off. It indicates that the U-
Bank may have malfunction. Please stop using the U-
Bank and contact the Mindray service engineers or
your sales representative.
6. Power button Used for checking the U-Bank power status.
7. Detach levers Used for detaching the U-Bank from the system.
One is located at front side, and the other is located at the
bottom.
NOTE:
Press the two levers at the same time to detach the U-
Bank from the system. When the U-Bank is placed on a
flat platform, just use the front lever to detach.
8. Lock/Release tabs Used for fixing the U-Bank to the system.
Release the U-Bank from the system by using the detach
lever(s).

2.8.2 Installing the U-Bank

1. Place U-Bank to a flat and solid platform.

2. Align the grooves of the system with the tabs of U-Bank.

Operator’s Manual 2 - 11
 2 System Overview

3. Push the system in the arrow direction as shown in the figure above until the system is locked
in place.

TIP:
To remove the U-Bank from the system, press the detach lever of U-Bank and lift up slightly the
system by holding the system’s handle.

2.9 ECG Module Overview

Figure 2-3 ECG module

No. Name Description

1. USB cable Connects to the USB port of the system.
NOTE:
• Ensure the system is powered off before connecting the
ECG module.
• The ECG module is only for use with the specified
system.
2. ECG lead port Used for ECG signal input.

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 2 System Overview

2.10 Control Panel

Figure 2-4 Control panel configured with trackball

1 2 3 4 5 6 7 8 9 10 11 12

13
24

14
23
22 15
21
20 16
19 18 17

Figure 2-5 Control panel configured with trackpad

1 2 3 4 5 6 7 8 9 10 11 12

13
24

14
23
22 15
21
20 16
19 18 17

No. Name English Name Description

1. TDI TDI mode button Enters TDI mode.
P4 User-defined key Undefined button, set by the user in preset.
2. CW CW mode button Enters CW mode.
iTouch iTouch button • Press to enter iTouch mode.
• Long press to exit iTouch mode.
3. M M mode button Press to enter M mode.
4. PW PW mode button Press to enter PW mode.
5. Measure Measure button Press to enter/exit application measurement.

Operator’s Manual 2 - 13
 2 System Overview

No. Name English Name Description

6. Update button Switching key: Press to change the currently
active window.
Start or end capturing the image in iScape/Smart
3D.
7. Caliper Caliper button Press to enter/exit general measurement.
8. C Color mode button Press to enter Color mode.
9. B B mode button Press to enter B mode.
10. P Power mode button Press to enter Power mode.
11. Dual-split window Press to enter the Dual mode from another mode.
button Press to switch between the two windows in the
Dual mode.
12. Image zoom Press to enter or exit zoom status.

13. iTouch/Gain Gain and iTouch Adjust the gain of the image in various modes.
knob • Press to enter iTouch mode.
• Long press to exit iTouch mode.
Gain Gain knob Adjust the gain of the image in various modes.
14. Depth Depth adjustment Adjust the depth parameter when the indicator is
button and on.
functional interface
15. Save static image Save images in a preset way.
button

16. Freeze button Press to freeze or defreeze the image.

17. / Confirm key (right Press to confirm the operation.

<Set> key)
18. / Trackball To move the cursor.
/ Trackpad To move the cursor; tap to confirm the operation.
19. / Confirm key (left Press to confirm the operation.
<Set> key)

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 2 System Overview

No. Name English Name Description

20. Standby status Standby indicator.
indicator Standby: blinking in orange.
Other status: light off.
Hard disk read Hard disk status indicator.
indicator The indicator blinks in green when hard disk is
running.
The indicator is off on the other status.
NOTE:
DO NOT move the machine when the
indicator blinking in green. Otherwise the hard
disk may be damaged by sudden shake.
Battery indicator Battery status indicator.
• Charging status:
It illuminates in orange when batteries are
charging;
It illuminates in green when batteries are
charged fully.
• Discharging status:
It illuminates in green color when the power of
the batteries is sufficient;
It illuminates in orange color for low battery
power.
21. Clear Clear button Press to clear off the comments or measurement
calipers on the screen.
22. Cursor button Press to show/hide the cursor.

23. Body mark/ • Press to enter/ exit the body mark/textual

/Angle/ Comment/Angle/ comment mode.
Multi- Multi-functional • Rotate to adjust probe marker orientation of
functional knob body mark.
knob • Rotate to adjust image parameters or direction
of comment arrows.
Angle/Multi- Angle/Multi- • Rotate to adjust probe marker orientation of
functional functional knob body mark.
knob • Rotate to adjust image parameters or direction
of comment arrows.
24. P3/P2/P1 User-defined keys Undefined buttons, set by the user in preset.

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 2 System Overview

2.11 Exam Main Menu Screen

Figure 2-6 Exam Main Menu

1 2 3 4 5 6 7

10 9 8

No. Icon Name Description

1. >/< Exam Main Menu Tap to enter exam main menu/return to the previous
switch bar screen.
2. Patient Information Tap to enter the Patient information screen.
button
3. Probe/exam mode Tap to switch probe and exam mode.
switch button
4. Scan button Tap to enter B imaging mode.

5. Patient data Tap to enter or exit patient information system.

management system
button
6. Image review button Tap to review the stored images.

7. Report button Tap to open/ close the exam report.

8. Screen Lock button Tap to lock the system for 10 seconds.

9. Setup button Tap to enter/exit Setup.

10. End exam button Tap to end an exam.

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 2 System Overview

2.12 Monitor Display

Figure 2-7 Monitor Display

9
1

4
5
6 7

No. Item Description

1. System Information Displays the manufacturer’s logo and product model.
Area
2. Parameters Area Displays the image parameters for the active window. If there
are more than one imaging modes, the parameters are displayed
by each mode.
3. Image Area Displays the ultrasound images, ECG waveforms, probe mark
(or active window mark), time line (in M or PW mode),
coordinate axis (including depth, time, velocity/frequency),
besides, the comments, bodymark, measurement calipers, color
bar/grayscale bar are also displayed here.
4. Hint (trackball/trackpad Displays the current functions of trackball/trackpad and <Set>
and <Set> key function keys.
indications)
5. User-defined Keys Area Displays the functions for the user-defined keys.
6. Help Information Area Displays various help information items or the progress bar in
the current status.
7. System Icons Area Displays the relevant system icons, such as USB memory
device, printer, network, and current system time, etc.
8. Clip board/Thumbnails Displays the thumbnail images stored under the current patient.
Area • When there are more than one page images have been stored,
you can turn to the next or preview page by or
respectively.
• Click to enter review screen.

Operator’s Manual 2 - 17
 2 System Overview

No. Item Description

9. Patient Information Displays the hospital name, the exam time, patient information,
Area the probe model, the exam mode, etc.
To preset which kind of patient information is displayed, see
“4.1.2 General”

2.13 Basic Operations

2.13.1 Dialog Box
Take the patient information screen as an example.

User Interface Controls

A dialog box screen consists of title, tab pages, contents and buttons, etc.
• Title bar
The title bar is used to give a description of the content and function of the screen.
• Tab page
For some screens, the contents are distributed across several pages. Use the <Set> key to open/
close the available pages.
• Content
– Radio box: click to select the item.
– Check box: click to check or uncheck the item.
– Text box: enter characters manually via the keyboard.
– Drop-down list box: click [▼] to show the list and select an item.
• Standard buttons
When the operation of a screen is completed, click the [OK] or [Cancel] button to save or
cancel the operation, and close the screen.

To reposition a dialog box

1. Use the trackball/trackpad to move the cursor onto the title bar of the dialog box.
At this time the cursor becomes a , then press <Set> key.
2. Use the trackball/trackpad and position the rectangular graphic to the new desired location.
3. Release <Set> key, and the dialog box is moved to the desired position.

2.13.2 Touch Screen

Select Exam Mode and Probe

CAUTION
If the exam mode is changed during a measurement, all measurement calipers
on the image will be cleared. The data of general measurements will be lost,
but the data of application measurements will be stored in the reports.

Connect proper probes to the system, and tap [Probe] on the touch screen, the touch screen displays
the following dialog box.

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 2 System Overview

Imaging Mode Screen

The layout of the touch screen varies with the applications or modes. Flip the touch screen to go to
another page. Learn the interface display and operations by referring to related chapters.
8 7 6

2 3 4 5
12 11

9 10

No. Item Description

1. Exam Procedure Display the exam procedure menu. see “4.1.2 General” to set
Group Touchpad Display after Ending Exams.

Operator’s Manual 2 - 19
 2 System Overview

No. Item Description

2. Parameter adjusting Displays the parameters in the current imaging mode or function.
area • Parameter magnitude setting: Tap the left/right part of the
parameter button, or tap to select the parameter button and rotate
the multi-functional knob to increase/decrease the value.
• ON/OFF setting: some of the parameters only can be set at ON or
OFF, ON is to activate the function, and when the function is
activated, the key is highlighted.
• Parameter submenu: tap to pop-up the submenu to select the
desired value.
NOTE:
If the parameters cover more than two pages, tap and slide the
area to left or right to find more.
3. Quick Adjustment Tap to quickly adjust the TGC sliders.
4. Restore button Tap to restore TGC to the original status.
5. Setup button Tap to enter TGC setup page.
6. Other application Displays the available application modes related, click to enter the
mode entrance modes.
7. Page-turning If there is more than one page of parameters for the current imaging
mode, you can slide to view more.
8. Mode displaying Displays the current modes, tap to enter the corresponding mode.
area (or main
functional tabs)
9. User Preset Displays user preset TGC slides.
10. Standard Preset The Standard Preset area provide standard TGC slides.
11. Exit button Tap to exit TGC setup page.
12. Save as button Select the desired slider position in the “Standard preset” or “User
Preset” column, make adjustment of the sliders manually if
necessary, and then touch [Save as] to select among Save as User1,
Save as User2, and Save as User3.

Bodymark and Comments

For products equipped with the trackpad, set user-defined keys for comments (text, arrow and trace)
and bodymark. Press (Body Mark)/<ABC> button or the user-defined keys to enter bodymark/
comment status.

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 2 System Overview

1
2 14
3
4

13
12
11
5 10
9
8
7

No. Item Description

1. Advanced setting Tap to change comment property:
button • To change font size, active text color and fix text color.
• To change arrow size and arrow style.
2. Bodymark tab Tap to enter bodymark status.
3. Comment tab Tap to enter text/arrow comment status.
4. Page If there is more than one page of comment texts for the current exam
mode, you can slide to view more.
5. Comment Tap to directly mark the position. Move the cursor onto the
position button comment item to be modified, and then tap the button to change the
already-added comment position.
6. Delete Word Tap to delete the latest comment.
button
7. Exit button Tap to exit the comment status.
8. Show/Hide Tap to display or hide the comments.
button
9. Keyboard button Tap to activate the soft keyboard to type the alphanumeric
characters.
10. Set Home button Set the start point of the comment cursor.
11. Home button Tap to return the cursor to the set home location.
12. Language button /
13. Arrow button Tap to add an arrow comment to the image.
14. Library Tap to pop up and select the library.

Controls on the touch screen

Tap and hold the screen to enter control editing stage.
You can not enter the stage from cine review mode or when there is a dialog box on the screen.

Operator’s Manual 2 - 21
 2 System Overview

Function Operations
Adding a control Tap to select a button to add and tap [Confirm].
Add a user-defined In comment and body mark editing status, tap and then tap [Custom] to
control bring out the dialog box for adding user-defined controls. Enter the control
name and tap [Confirm].
Delete a control Tap of the target control and tap [Confirm] to delete.
Change the control Tap and drag the control to the desired position.
position

2.13.3 Voice Recognition

TIP:
Currently, only wireless microphone devices can be inserted to the system for inputting vocal
commands.

Figure 2-8 Voice Control Panel

1 2 3

No. Description
1. Click to speak to the microphone (the system recognizes the vocal order). The
system conducts the operations after recognizing the voice.
2. Click to stop the voice Recognition.
3. Click to open the help information.

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 2 System Overview

2.14 Warning Labels

The warning labels are attached to this system in order to call your attention to potential hazards.
The warning labels use the same signal words as those used in the operator’s manual. Read
operator’s manual carefully before using the system.
The name, pattern and meaning of each warning label are described as follows:

No. Warning Labels Meaning

1. Read this information carefully before using the
system.

2. The following labels are 1. Do not place the system with the mobile trolley
available when the system works on a sloped surface. Otherwise the system may
with the mobile trolley. slide, resulting in personal injury or the system
malfunction. Two persons are required to move
 the system over a sloped surface.
2. DO NOT sit on the trolley.
3. When the casters are locked, DO NOT push the
  trolley.

3. Non-ionizing radiation

4. MR Unsafe – the system is not intended to be used

within magnetic resonance (MR) environment.

2.15 Symbols
This system uses the symbols listed in the following table. Their meanings are explained as follows:

Symbol Description
Type-BF applied part

Caution!

Standby

Operator’s Manual 2 - 23
 2 System Overview

Symbol Description
Transducer sockets

Used for s-video output.

Network port

HDMI port

USB port

AC (Alternating current)

Standby indicator

Harddisk indicator

Battery indicator

Unlock position

Lock position

Dust-proof mesh

ECG lead port

Equipotentiality

Product serial number

Manufacture date

Manufacturer

Temperature limit

Humidity limitation

2 - 24 Operator’s Manual
 2 System Overview

Symbol Description
Atmospheric pressure limitation

Main unit release button on the trolley

Main unit tray release button on the trolley

Maximum load for small storage bin on the

MT3 trolley
Maximum load for big storage bin on the MT3
trolley
Maximum load for main unit tray on the MT3
trolley
MT3 Trolley AC output

MT3 Trolley DC output

MT3 Trolley input

Power adapter bracket on the MT3 trolley

Maximum load for the storage bin on the MT2

trolley

Power consumption

Federal law restricts this device to sale by or on

the order of a licensed healthcare practitioner
(USA).
CONFORMS TO AAMI STD ES60601-1, IEC
STD 60601-2-37, IEC STD 60601-1-6;
CERTIFIED TO CSA STD C22.2 NO. 60601-1,
60601-2-37, 60601-1-6

Operator’s Manual 2 - 25
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3 System Preparation

3.1 Move/Position the System

Read and understand the safety precautions before positioning the system to ensure the safety of
both the operator and the devices.
1. Switch off the power, and pull out the power plug.
2. Disconnect all cables from off-board peripheral devices.
3. Place the system in a desired location.
Leave at least 20 cm at the back and both sides of the system.

CAUTION
Maintain a generous, free air flowing space around the back and both sides of the
system. Not doing so may result in failure due to the increased rise in the system's
operating temperature.

3.2 Connecting the Power Cord

This system can work normally only when it is connected to the external power supply or the
battery capacity is sufficient.

3.2.1 Connecting Power

1. Connect the connector of the power adapter to the adapter port in the system.
2. Use a three-wire cable to connect the adapter with the external power supply.
If you have any question about the power adapter, please contact your sales representative.

NOTE:
• You must use the specified power adapter.
• Do not use this power adapter in the conditions other than those specified.

3.2.2 Powered by Batteries

When connected to the external power supply, the system is powered by the external power. The
lithium ion batteries inside it are in the charging status, the indicator turns off when the capacity is
full.
When disconnected from the external power supply, the system is powered by the lithium ion
batteries.

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3 System Preparation

WARNING
• The battery is inside the machine. Only Mindray technical professionals or
engineers authorized by Mindray following training can perform battery
installation and uninstallation.
• If you need to change the battery or buy a new one, contact your sales
representative.
• The replacement of lithium batteries by inadequately trained personnel
could result in a HAZARD (such as excessive temperatures, fire or
explosion).
• The lithium-ion battery has a service life of five years. Replace your battery
when it reaches the end of its service life.

Battery Performance
Under power off or standby status, charging time of the battery from capacity 0 to 100% takes less
than 4 hours.

NOTE:
Power off the system if it will not be used for a long period of time (including storage/transportation
condition). Do not leave the system in standby status, otherwise the batteries will be discharged and
permanently damaged.

Battery specification
• Voltage: 14.4 V
• Capacity: 6600 mAh (single battery)

Battery Status Indicator

The battery status indicator is located in the bottom-right corner of the screen, indicating the battery
capacity.
• : Indicates the battery capacity is nearly empty.
• : Indicates the battery capacity is full.

NOTE:
When the battery power drops to 6%, a window will pop up warning and force the shutdown
process. You can exit the shutdown process after connecting the power adapter.

3.3 Power ON/OFF

CAUTION
To ensure safe and effective system operation, you must perform daily
maintenance and checks. If the system begins to function improperly,
immediately stop scanning. If the system continues to function improperly, fully
shut down the system and contact the Mindray Customer Service Department

3-2 Operator’s Manual

 3 System Preparation

or a sales representative. If you use the system in a persistent improperly

functioning state, you may harm the patient or damage the equipment.

3.3.1 Check before Powering ON

Check before the system is powered on:
• The temperature, relative humidity and atmospheric pressure meet the requirements of the
operating conditions, for details see “2.4.2 Environmental Conditions”.
• There is no condensation.
• There is no distortion, damage or dirt on the system and peripheral devices.
If any dirt is found, cleaning shall be performed, see “18 System Maintenance”.
• There are no loose screws on the monitor, control panel or the trolley.
• There is no cable damage (e.g., power cord). Maintain secure connections to the system at all
times.
• The probes and probe cables are free from damage or stains.
For details of probe cleaning and disinfection, see “16.1.5 Probes Cleaning and Disinfection/
Sterilization”.
• No miscellaneous odds and ends are attached or affixed to the control panel.
• Ensure that all connections are free from damage and remain clear of foreign object blockages.
There are no obstacles around the system and its air vent.
• Probe cleaning and disinfection.
• The entire scanning environment and field must be clean.
• The locking mechanism of the casters (if there is a trolley) works normally.

3.3.2 Power the System ON

Press the power button to power the system on.
If access control has been set by the system administrator, you can access data in the system only
after logging onto the system. For details, see “4.1.10 Access Control”.
You must log in again after system restart or dormancy.

To login onto the system

Perform the following procedure:
1. Select the login type (Local or LDAP), and user name in the drop-down list.
2. Enter the password and click [Login].
When the user has logged onto the system, is visible in the bottom-right corner of the
screen.

To change users
Perform the following procedure:
1. To log out the current user and change to another user, click in the bottom-right corner of
the screen to bring up the following dialog box

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3 System Preparation

2. Click [Change User] to bring up the Login dialog box.

3. Select the login type, and user name in the drop-down list.
4. Enter the password and click [Login].

To modify password
General operators and administrators can modify the password.
Perform the following procedure:
1. Click in the bottom-right corner to bring up the Session Manage dialog box where you can
see the current user’s information.
2. If you want to modify the current password, click [Change Password] to bring up the Change
Password dialog box.
3. Enter both the previous and new passwords, and confirm the new password in the dialog box.
4. Click [OK] to exit.

To lock the system

Perform the following procedure:
1. Click the in the bottom-right corner of the screen to bring up the dialog box.
2. Select [Lock Machine] and the system is locked.
You must log on before using the system.

3.3.3 Check the system after it is powered on

Check after the system is powered on:
• There are no unusual sounds or smells indicating possible overheating.
• There are no persistently displayed system error messages.
• There is no evident excessive noise, or discontinuous, absent or black items in the B mode
image.
• Check whether there is abnormal heat on the surface of the probe during an ultrasound
procedure. If you use a probe which is giving off excessive heat, it may burn the patient.
• The control panel keys and knobs are fully functional.
• The date and time are displayed correctly.

WARNING
• If you use a probe giving off excessive heat, it may burn the patient.
• If you find anything not functioning properly, this may indicate that the
system is defective. In this case, shut down the system immediately and
contact Mindray Customer Service Department or sales representative.

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 3 System Preparation

NOTE:
When you start the system or switch between transducers, you will hear clicking sounds – this is
expected behavior.

3.3.4 Power the System Off

You must follow the correct procedures to power the system off. Also, after you upgrade the
software or when the system is down, you need to power off and restart it.
If you will not use the system for a long period of time, you shall:
• Disconnect the power adapter.
• Disconnect the mains power.
• Turn off powers of all peripherals connected to the system.

To power the system off

Perform the following procedure:
1. Press the power button to see the option:
– Shutdown: to power the system off normally.
– Standby: to enter standby status.
– Cancel: to cancel the operation.
2. Select [Shutdown] to power the system off.

NOTE:
• Press and hold the power button for a long time and the system will power off without
displaying the “Shutdown Confirm” screen. However, shutting down the system this way may
destroy the data.
• DO NOT rush direct shutdown of the system. It may damage the data.
• After the system is upgraded, use [Shutdown] to power the system off to make the upgraded
data effective.

3.3.5 Standby
NOTE:
• Power off the system if you will not use the system for a long period of time (including
storage/ transportation condition), and you should not allow the system in standby status,
otherwise the batteries will be out of power and permanently damaged.
• If the system will not be used for a long period of time, you should disconnect the power
adapter, disconnect the mains power, and turn off the power to all peripherals connected to the
system.

To enter standby
• Fully fold the LCD display and wait for 30 seconds, then the system enters the standby status.
• Set the time for screen saver and standby, see “4.1.2 General”. If the system is not carrying out
an operation, the screensaver appears after the screensaver delay period. If there is still no
operation, the system enters standby after the standby delay period.
• Press the power button and select “Standby”.

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To exit standby
• Unfold the LCD display.
• Press the power button.

3.4 Monitor Brightness/Contrast Adjustment

Monitoring the brightness and contrast adjustment is one of the most important factors for proper
image qualities. If set incorrectly, the gain, TGC, dynamic range or even acoustic output have to be
changed more often than necessary to compensate.
For details about adjustment, see “4.1.2 General”.

NOTE:
On the monitor, the brightness adjustment comes before contrast. After readjusting the monitor’s
contrast and brightness, adjust all preset and peripheral settings.

3.5 Connecting/Disconnecting a Probe

CAUTION
• Press <Freeze> to freeze an image or turn off the power of the system
before connecting/disconnecting the probe. Otherwise, system or probe
failure may occur.
• When connecting or disconnecting a probe, place it in the proper position to
prevent the probe from falling off or becoming damaged.
• Only use probes provided by Mindray. Aftermarket probes may result in
damage or cause a fire.

3.5.1 Connecting a Probe

WARNING
The probes, cables and connectors should be in proper operating order and
free from surface defects, cracks and peeling. Otherwise, this may lead to
electrical shock.

NOTE:
Before inserting the connector into the probe port, inspect the connector pin. If the pin is bent, do
not use the probe until it has been inspected/repaired/replaced.

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Perform the following procedure:

1. Keep the cable end of the transducer to the front side of the system, insert the connector into
the system port, then press in fully.
2. Toggle the locking lever to the lock position.
3. Position the probe properly to avoid it being treaded on or becoming wrapped around other
devices. DO NOT allow the probe head to hang free.

3.5.2 Disconnecting a probe

Perform the following procedure:

1. Toggle the locking lever to the unlock position.
2. Pull the transducer connector straight out vertically.

3.6 Connecting USB Devices

WARNING
DO NOT directly remove a USB memory device, as the USB device and/or the
system may become damaged.

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3 System Preparation

• When connecting a USB memory device to the ultrasound system via a USB port, a sound is
heard if it is connected successfully and the symbol appears in the bottom-right corner of
the screen.
• To remove the USB device: click to open the [Remove USB Device] screen. Select the
device to be removed and click [OK]. A sound is heard when removing the USB memory
device.
• The system supports option of external DVD R/W drive. The DVD R/W drive is connected to
the ultrasound system via USB port.

NOTE:
• When connecting an external DVD R/W drive, connect the two cables of the drive to the
ultrasound system if the drive provides 2 USB power cables. In this way, the DVD R/W drive
can work more normally.
• If the USB disk cannot be recognized by the system, please try disconnecting and then
connecting again several times, or try another USB disk. If the problem still exists, please
contact Mindray service engineer.

3.7 Connecting the Footswitch

The system supports USB port-type foot switches.
The function of the foot switch can be preset. For details, see “4.1.7 Key Configuration”.

3.8 Installing a Printer

TIP:
• Printers listed in Section 2.6.4 have drivers installed already.
• If the printer driver is required, please contact Mindray Customer Service Department or sales
representative.
• Please refer to the accompanying manuals of the printers for more details.

3.8.1 Connecting a Graph/Text Printer

As shown in the figure below, a graph/text printer has a power cord and data cable. The power cord
shall be directly connected to a wall receptacle as required.

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 3 System Preparation

2
1

1 Power supply cable Connect to power supply.

2 Data cable Connect to the USB port of this system.

Perform the following procedure:

1. Connect the data cable to USB port of the ultrasound device.
2. Power on the system and the printer.
3. Preset the default report printer and its attribute:
a. Open [Setup] > [Print] screen.
b. Select the “Report Print” column in the Service Type list.
c. In the “Property” frame, select printer from the driver list next to “Printer” in the lower
screen and set the items.
d. Click [Save] after you have finished setting.

3.8.2 Connecting a Video Printer

The digital video printers that system supports consist of the B/W printers and color printers.
Perform the following procedure:
1. Place the printer appropriately.
2. Connect the power cord of the printer to a receptacle. Connect the USB port of the system to
the USB port of the printer with USB cable.
3. Load a paper roll and turn on the system and printer.
4. Add a print service:
a. Open [Setup] > [Print] screen.
b. Click [Add Service] to enter the page.

c. Select the service type and enter the service name manually.
d. Click [OK] to return to the page.

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e. Select the target printer from the drop-down list in the “Property” box and set other
printing properties.
f. Click [OK] to complete.

3.8.3 Connecting a Wireless Printer

The system supports the wireless graph/text printer for the report print.
Perform the following procedure:
1. Plug the printer power cord to an appropriate outlet.
2. Power on the system and the printer.
3. Make sure the ultrasound machine and the printer are connected to a same LAN, and turned on
the W-LAN function of the printer.
4. Select [Setup] > [Print] to choose the report to be printed. Select the printer from the wireless
printer list, and set the printer.
5. Click [Save] to exit the preset and make the settings effective.

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4 Setup

The Setup function is designed to set the configuration parameters of operating the system and
maintaining user workflow setup data. The setup data of the user and system are stored to the hard
drive, and should be backed up to CD/DVD or USB memory device.

CAUTION
When the preset data is changed, be sure to save the preset data according to
the methods described in this chapter. Mindray is not responsible for the loss of
preset data.

• To enter Setup:
Tap [Setup] on the exam main screen of the touch screen.

• To exit Setup:
– Select [OK] in the Setup menu. The parameter settings are saved.
– Select [Cancel] in the Setup menu to close the Setup menu.
When you change the system language and click [OK] in the Setup menu, the system
automatically shuts down to make the modification effective.
• Basic operations
The commonly-used setting types are:
– Text box: position the cursor over the corresponding field box. Enter the desired value
using the soft keyboard on the soft menu.
– Radio button: click the button to select an item.
– Check box: click the checkbox to select one or more options.
– Drop-down list: click the arrow beside the list to select an item.

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4 Setup

4.1 System Preset

4.1.1 Region
Set the hospital name, language, time zone, time format and system date/time.

Item Description
Hospital Information To set the hospital-relevant information such as name, address,
telephone, and so on.
Language To select a language (input) for the system.
Load Logo Import image for logo loading.
NOTE:
For a better display effect, please try to use an BMP image with
400*400 pixels and 8/24/32 bitdepth.
Time Zone To select the time zone.
Time Format To select the time format.
Date Format To set the date format.
System Date To set the date for the system.
System Time Move the cursor over the corresponding field and enter the time
manually using the keyboard, or, move the cursor over the time segment
and press <Set>, then increase or decrease the required value by
clicking the icons on the right side.
Time Synch To assign a time server and make the time of the ultrasound machine
consistent with the server.

4.1.2 General
Set patient information, exam setup, patient management, storage, system dormancy, auxiliary
output setting and so on.

Type Item Description

PATIENT INFO Patient Banner To select whether to display the available patient
Display Content information items on the screen.
H&W Unit To set the unit for calculating patient height and weight.
Surface Formula To set the surface formula.
Font Size (For To set the font size in the Patient Banner Display
Storage) Content for storage.
Status after freeze To set the system state after the image is frozen.
Storage Beep Set the key volume for saving single /multi-frame
Volume image.

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 4 Setup

Type Item Description

EXAM SETUP Status after exam To set the system status when an exam ends.
ends
Touchpad Display To set the touchpad display when an exam ends.
after Ending
Exams
Auto Screenshot of After selected, perform measure application and save
Report Page by single frame image, then end the patient exam, the
Page system will save the report image in iStation.
Sending/printing Select whether to automatically archive the exam data
after Ending to the DICOM server for storage/print.
Exams
Send SR after Select whether to automatically send structure report to
Ending Exams the DICOM server.
Speed up the Select whether to speed up the export of exams after
export of exams prospective saving the cine.
Maximum number To set the maximum number of exams to be kept. If the
of exams to be kept actual number is larger than the preset number, the
latest exam will replace the earliest exam.
NOTE:
The patient exams which exceed the preset
maximum will be deleted and unrecoverable, it is
recommended to perform patient data backup before
enabling this function to avoid data loss.
Exam cannot be To set the time when the exam can be activated after the
activated after end of the exam.
NOTE:
• The default value is 1 day. Only exams within 24
hours can be activated by default.
• If not set, all the ended exams can be activated.
• The patient information can be added or modified
after activating the exam.
• The exam image can be added after activating
the exam, without affecting the previously saved
exam image.

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4 Setup

Type Item Description

SCREEN SAVER ScreenSaver Select the different saver methods to the system.
After enabling the screen saver, check “Select Picture-
Mindray” to select the image from the system. Or click
[Review] to select the image on your own; you can set
the interval time for the screen saver slideshow in the
drop-down list beside “Interval”.
To set the waiting time before the system enters
dormancy status in the drop-down list beside “Wait”.
The system enters screen saver automatically if the
system waiting time exceeds the screen saver already
set.
Standby The system enters screen saver automatically if the
system waiting time exceeds the screen saver already
set and standby time.
CoverOff-Standby After folding down the monitor, the system enters
standby mode automatically if the waiting time exceeds
the CoverOff-Standby time.
DISPLAY Brightness auto To set the brightness/contrast of the main screen and the
adjustment touch screen according to the conditions.
LCD To set the brightness and the contrast of the main
screen, or restore to the default.
TouchPanel After selection, the system restores the touch screen
settings back to factory.
IVOCAL Automatically shut To set the delay before voice recording stops
down waiting time. automatically.
Enable Voice After it is ticked, the system will repeat recorded voice
Response commands automatically.

4.1.3 Image Preset

Controls are as follows:

Type Item Description

RESET CONFIG Probe To set the default probe model for the system
from the drop-down list.
The default parameters are applied to the new
probe if checking “Use the default setting
when start a new exam.”
Image size Set the standard for saving the image or using
the digital/graph printer.

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 4 Setup

Type Item Description

PARAMETER Steer To set the steer mode in B + Color + PW/CW
imaging mode.
• C&(PW/CW): select to adjust the sample
volume in color mode and sample line in
PW or CW mode together.
• C/(PW/CW): select to adjust the sample
volume in color mode and sample line in
PW or CW mode separately.
Auto Invert The spectrum can automatically invert when
the color flow is steered to a certain angle, thus
accommodating the operator’s wish to
distinguish the flow direction.
iScape Ruler Display To set whether to display the iScape ruler in
iScape imaging mode.
B+Color Refresh with PW/ To set whether to turn on the function that
CW Sampling Line when moving PW/CW sampling line, B+Color
Movement image is activated under B+Color+PW/CW
mode.
Uninterruptible image saving Adjusting reprocessing parameters will not
when reprocessing interrupt image/cine saving.
parameters are changed
Color And PW/CW Adjust preprocessing parameter, refresh 2D/
Synchronize Invert M/Doppler cine.
Color And PW/CW To set whether to invert Color Map and PW/
Synchronize Invert CW spectrum synchronously
Display Transducer SN To set whether to display the transducer SN.
B+Color+PW UnFreeze To set whether to retain PW images when
keeping PW unfrozen under B+Color+PW mode.
TOUCH Touchpad Layout Design To set the layout style of the touch screen.
SCREEN
TISSURE Segment Model To set the cardiac segment model: 16 or 17.
TRACKING QA

4.1.4 Application
Set the measurement ruler, measurement setting, follicle method, left ventricular setting, comment
setting and so on.

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4 Setup

Measure Ruler
Controls are as follows:

Item Description
Cursor Type Type of cursor displayed on the measurement caliper and results
window. Value options:
• Number: the cursor always displays as “+” while different
measurements are marked with numbers.
• Symbol: the cursor displays sequentially in 8 symbols to identify
different measurements.
Cursor Size The size of the cursor.
Heart Beat The number of cardiac cycles in the heart rate calculation. (In heart rate
measurement, the number of cardiac cycles should match the preset
number.)
Cursor Line Display If unselected, the connecting line between the measuring ends will be
hidden after measurement.
Ellipse Cross Line If unselected, the measuring axis within the ellipse area will be hidden
Display after measurement.
Clear results while Uncheck. The image is unfrozen or the image mode is changed after the
deleting caliper measurement is completed. The measurement results are saved if the
caliper is cleared.
Unit Setting To set the measurement unit.

LV Cube/Teichholz/Gibsom
Set the tools used in the Cube/Teichholz/Gibson study.

Follicle
Set the method for calculating the follicle.

PW Measure
PW measure velocity displays absolute value.
All measurement results in PW mode are absolute values based on the unit of velocity after
checking this item.

Comment
Set whether to clear comments and bodymark:

Item Description
Clear comments while unfreezing To set whether to clear comments while unfreezing image
image or changing probe/exam or changing probe/exam.
Clear Bodymark upon unfreeze To set whether to clear bodymark whiling unfreezing
image.
Press comment/bodymark key enter To set enter comment mode after pressing comment/
comment mode bodymark key.

Intelligent Input
Set to enable the Input Method Association.

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 4 Setup

ICA/CCA && RAR

Set the measurement properties of ICA, CCA, Renal A and Aorta.

CARDIAC VALUE RANGE DISPLAY

Set whether to display the EMINCA study.

Item Description
7he number of decimal places of It is selected by default. When it is not selected, the
measurement data in SR report is measurement data in the SR report uses the same number
consistent with those displayed in the of decimal places as the original measurement data.
system.
The number of decimal places of Sets the number of decimal places of measurement result
measurement result that is displayed that is displayed in millimeters. One decimal place is set
in millimeters by default.

4.1.5 OB
Set the relevant information regarding the fetal gestational age, fetal growth formula and fetal
weight.

To set the default formula

Perform the following procedure:
1. On the [Fetal Gestational Age], [Fetal Growth] or [Fetal Weight] page, select an OB Item in
the left column.
2. Select a formula in the right column.
3. Click [Default].
The default formula is marked with a √.

To set the fetal weight display

Perform the following procedure:
1. Enter the [Fetal Calc] page.
2. Select the [Fetal Weight Unit].
Select Metric, English or English & Metric from the drop-down list.
3. Select the formula for calculating the weight percentile.
Select the formula from the drop-down list of [EFW-GP].

To import/export an OB Table or Formula

TIP:
Only imported user-defined tables can be exported.

Perform the following procedure:

1. Select [Import] or [Export] on the Fetal Gestational Age or Fetal Growth page.
2. Select the drive and file path where the data is located.
3. Select the data file to load or export, click [OK] to confirm.

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4 Setup

The imported user-defined table for FG and GA must be a *.csv file. The format of the *.csv
file is described as follows:
– FG table

Table Type Author Name SD Type Meas Value SD Unit

Unit
FG The author name Value of standard Unit of the Unit of the
deviation measurement standard deviation
value

Row Num Row number (N)

of the table
No. GA Min Meas Value Max
1 GA value Minimum value Measurement Maximum value
value
2 … … … …
… … … … …
N … … … …

NOTE:
• Fill in the table according to the actual clinical values, except for those cells with bold
text.
• Value of standard deviation. Select from one of the following: None, ±1SD, ±2SD,
3%~97%, 5%~95%, 10%~90%.
• Unit of the measurement value: according to the table to import, select from mm, cm, g,
kg, cm² or mm².
• Row number (N) of the table: the maximum row number N in the column “No.”
• The third row is empty.
• GA value, Minimum value, Measurement value, Maximum value: enter the number of
days without the unit.
– GA table

Table Type Author Name SD Type Meas Value

Unit
GA The author name Value of standard Unit of the
deviation standard deviation

Row Num Row number (N)

of the table
No. Meas Value SD(-) GA SD(+)
1 Measurement Standard GA value Standard deviation
value deviation (-) (+)
2 … … … …
… … … … …

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 4 Setup

N … … … …

NOTE:
• Fill in the table according to the actual clinical values, except for those cells with bold
text.
• Value of standard deviation. Select from one of the following: None, ±1SD, ±2SD,
3%~97%, 5%~95%, 10%~90%.
• Unit of the measurement value: according to the table to import, select from mm, cm, g,
kg, cm² or mm².
• Row number (N) of the table: the maximum row number N in the column “No.”
• The third row is empty.
• Measurement value, Standard deviation (-), GA value, Standard deviation (+): enter the
number of days without the unit.

User-defined OB Items

NOTE:
The calculation results of the user-defined OB formulae are used for reference rather than clinical
diagnosis.

You can add user-defined formulae for items (obstetric tools) that are not included in the GA and
FG table.
1. Select [More OB Items] on the Fetal Gestational Age or Fetal Growth page.
2. Select an item and click [OK].
3. The new item appears in the left column and the system asks if to add a formula.
4. Click [OK] to select the *.csv file (formula file) for the item. Or add a formula for the new item
by clicking [Import].

Measure Result
EDD display: the EDD is displayed in the result window after checking.

GA Cycle For EDD

• Normal Cycle: GA is calculated according to 40 weeks after checking (EDD=LMP+287(40
weeks)).
• French Cycle: GA is calculated according to 41 weeks after checking (EDD=LMP+287(41
weeks)).

Display EFW GA in report

Estimate GA according to EFW data after checking.

4.1.6 Key Probe

Assign functions to the key probe buttons.

Item Description
K1 To set the function of K1 button.
K2 To set the function of K2 button.
K3 To set the function of K3 button.

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 4 Setup

Item Description
Enable Key Probe Key After it is ticked, the key function of Key probe is enabled.
Function

4.1.7 Key Configuration

Assign functions to the foot switch and user-defined keys.

Key function setting

You can set the functions for <Save> and user-defined keys.
To assign a function to a key:
1. Click to select the desired key in the Key Function column on the left side of the page.
2. Click to select a function in the Function area. You can see the available functions selected on
the right side.
3. Click [OK] to complete the function setting.

Footswitch Function Setting

You can assign a function to the left/middle/right key of the foot switch. The method is similar to
setting key functions. See the steps above.

Trackball Speed
Set the speed of the trackball when using the trackball.

Key Volume
Set the key volume level.

Key Brightness
Set the brightness for the keys.

Trackball Light
Set the light color for the trackball.

Touchscreen Volume
Set button volume level on the touch screen.

Auxiliary Output Function

For the following three functions, the system provides auxiliary output function setting: “Save
Image”, “Save Cine (Retrospective)” and “Save Cine (Prospective)”. When the corresponding user-
defined key is pressed, the system can perform multiple operations one by one as per the preset.
• Save the single-frame image:
– Send image to DICOM storage
– Send image to DICOM print
– Send image to USB disk
– Send image to iStorage
– Send image to local printer
• Retrospective/prospective saving cine:
– Send cine to DICOM storage
– Send cine to USB disk

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 4 Setup

– Send cine to iStorage

Setting method (taking “Save Image” as an example, add the auxiliary functions “Send Image to
DICOM Storage” and “Send Image to USB disk”):
1. Select a key in the Key Function field on the left side and select “Save Image” in the Output
page of Function field on the right side.
2. Click [Add] in the middle part of the screen, then there will be “Function 2: NULL” under the
key function in the Key Function Field on the left side, and at the same time, “Output” column
on the right side will show the available auxiliary functions for current key. Select “Send
Image to DICOM Storage” in the “Output” column on the right side. Then the Function 2 on
the left side turns into “Send Image to DICOM Storage”.
3. Click [Add] again, then there will be “Function 3: NULL” under the key function in the Key
Function Field on the left side. Select “Send Image to USB disk” in the “Output” column on
the right side. Then the Function 3 on the left side turns into “Send Image to USB disk”.
4. Click [OK] to confirm.
5. Scan and freeze the image
6. Press the user-defined key, then the system will perform three steps:
a. Save the image to the local hard disk.
b. Send image to DICOM Storage server.
c. Send the image to USB disk.

TIP:
Repeat step 3 will continue adding auxiliary functions; you can add 6 functions at most.

4.1.8 Gesture
The gesture setting is the same with the settings of other keys, see “4.1.7 Key Configuration”.

4.1.9 Output
Set the output format, the range and the resolution for the image.

Type Item Description

AVI ENCODE Encode Quality To set the image quality of unloaded AVI. The system
unloads according to the settings.
The higher the image quality is, the clearer the
unloaded image is. The unloading speed become
slower with the larger space.
Operating System To set the unloading format of the AVI. The system
Compatibility unloads according to the settings.
If checking “Mac OS”, saving CIN files to USB flash
drive as “MP4 Video”.
Send To Frame Rate To set whether to enable/disenable compression of
images.
Analog Output To set the format to output/separate the video format:
Mode NTSC or PAL.
COLTEMP To set screen color temperature: Warm or Cold.

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 4 Setup

Type Item Description

DIGITAL Output Size Select VGA, HDMI output image range.
OUTPUT
Resolution Select VGA, HDMI output image resolution.
DVR OUTPUT Output Size Select DVR recording area.
DIALOG White background To set the white background for dialog storage.
STORAGE for dialog storage

4.1.10 Access Control

The system supports two types of users: administrator and operator.
• Administrator
The system administrator can access all function modules, and view all patient data, such as
patient information, images and reports, etc. Only one administrator is configured by default.
The administrator can add or delete operators.
• Operator
The operator can only access the function modules with assigned privileges. The operator can
only view exam information saved in the system and operated by him or herself, such as
patient information, images and reports, etc.

Enabling Access Control

The system administrator can preset the access controls, that is, whether an operator has the right to
access data in the system.
Access control only can be set by the system administrator.
Open the “Access Control” page:
• If “Enable User Account Control” is selected, you must be authorized before accessing the
data, and you can configure password policy and LDAP, and change password. If unselected,
you can access all the data without authorization, and you cannot configure password policy
and LDAP, and change password.
• If “Enable Emergency User” is selected, the administrator can edit privileges for emergency
users. If unselected, the administrator cannot edit privileges for emergency users.

Adding a User/Assigning privilege

Turn on the access control function and log in to the system as Administrator before you add the
user.
1. Click [Add] to bring up the dialog box.
2. Enter the user name and password, confirm password.
3. Select or deselect the check box from the privilege list.
Users can only access the function module with assigned privilege.
4. Click [OK] to confirm the setting and exit the dialog box.
The new user and the privilege will appear in the User List.

Deleting a User
Turn on the access control function and log in to the system as Administrator before you delete the
user.
Select the user to be deleted in the User List. Click [Delete] to delete the selected user.

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Editing Privilege
Turn on the access control function and log in to the system as Administrator before you edit
privileges.
1. Select a user, click [Edit Privilege] to enter the “Edit user privilege” dialog box.
2. Select or deselect the check box from the privilege list.
3. Click [OK] to confirm the editing and exit the dialog box.
The edited privileges will appear in the User List.

Modify Passwords
The system administrator can modify all user passwords. The administrator password is empty by
factory default. You can set this password.
An operator can only modify his/her own password.
1. Select the user name to be modified in User List.
2. Click [Change Password] to open the dialog box.
3. Enter current password, new password and confirm new password, then click [OK].

Configure Password Policy

Turn on the access control function and log in to the system as Administrator before you configure
the password policy.
Click [Password Policy Config]:

Item Description Remark

Lockout Set the maximum time that a user can input the For example, assume that the
Threshold wrong password. If you exceed the maximum “Lockout Threshold” is set
times, your account will be locked. to 5, the “Reset Account
Lockout Threshold after” is
Reset Account Set the duration allowed for a user to
set to 60, and the “Lockout
Lockout continuously input the wrong password.
Duration” is set to 60. That
Threshold after
is, a user inputs the wrong
Lockout Duration Set the duration after an account is locked. password for 5 times within
60 minutes, the account is
locked, and the user can log
in to the system only after 60
minutes. Other users with
unlocked accounts can still
log in to the system
normally.
Reset all lockout Reset all locked accounts. /

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 4 Setup

Item Description Remark

Enable strong Enable strong password to improve security. /
password • If the strong password is enabled and you
log in to the system with the account that is
added before the strong password is
enabled, the system prompts a warning
message to inform you whether your
password conforms to the password policy.
The administrator can change password for
administrator or operator.
• If the strong password is enabled and you
add a new user account, the system prompt
an error message to inform you that the
password is too weakplease modify the
password according to the error message.

LDAP Privilege Management

Turn on the access control function and log in to the system as Administrator before you edit
privileges for the LDAP (Lightweight Directory Access Protocol) users.
Click [LDAP Config]:

Item Description
LDAP Type To set the type of LDAP.
Service Address Enter the server address in the field box after accessing the network
Test LDAP Server To test whether the LDAP server is accessible. If the LDAP is
accessible, the system prompts the following message “Server test
succeeded.”
Root DN It is automatically displayed after the server is successfully tested.
Default Domain The default domain is the DC name in the Root DN. For example, if
DC=security1, then input "security1" in the field box of the "Default
Domain"
Days to keep cached Set days to keep the cached passwords in the local system.
password Users can log in to the server even without accessing the network
within the setting days.
• Empty: the passwords are kept in the local system permanently.
• 0: no passwords are kept in the local system.
• ≥1: for example, if it is set to 5, the passwords are kept in the local
system for 5 days.
Member of filter/Privilege • Enter the member name, and select or deselect privileges from the
drop-down list of “Privilege”.
• Click [Add], and the new members and privileges will appear in
the Member of filter list.
• Select a member to be deleted, and click [Delete].
• Select a member to be modified, modify the member name, and
select or deselect privileges from the drop-down list of
“Privilege”. Click [Modify], and the modified member name and
privileges will appear in the Member of filter list.

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Item Description
Logon Test 1. Enter the User name and password in the field boxes of the
Authentication test area.
2. Click [Logon Test] to test whether the user is authenticated.
User field name Select [Use user field name] to customize the user field name. After
that, the members and privileges cannot be edited.
Enter the user field name in the field box of the “User field name”
(the user field names are configured in the LDAP server. For details,
please refer to the LDAP server manual).
The user field name corresponding to privileges are as follows:
• iStation Access: 1
• Save Exam: 2
• Export Exam: 4
• Network Settings: 8
• Maintenance Menus: 16
• System Settings: 32
• Workflow Settings: 64
• Worklist Access: 128
NOTE:
The privilege items can be combined randomly. For example, if
user A is assigned with all the above 8 privileges, the user field
name for user A is 1+2+4+8+16+32+64+128=255.

Auto Lock Machine

To set the waiting time before the system enters locked status in the drop-down list beside “Wait”.
The system will be locked automatically if the system waiting time exceeds the duration already
set.

Scene Preset Management

The system can manage preset data under different scene applications. When the feature is turned
on, you can use different preset data for print, DICOM, iStorage and eGateway services.
To enable the function:
1. Check the checkbox next to “Enable Preset Scence Mangement”.
2. Click [OK] to confirm.
3. Switch different scenarios:
a. In non-preset screen, press <Cursor> to show the cursor and move the cursor to the
bottom-right corner of the screen. Click icon to see the scene management list.

b. Position the cursor on the target scene and press <Set> to switch.

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4. Configure scenes:
a. In non-preset screen, press <Cursor> to show the cursor and move the cursor to the
bottom-right corner of the screen. Click icon to see the scene management list.
b. Click [Configure] to see the following dialog box.

c. Add scenes: click [Add] and enter the scene name in the Add Scene dialog box and then
click [OK].
d. Click to select the target scene name in the Scene Name list on the left side.
e. Click to select a desired preset service on the right to open the screen.
f. Set necessary parameters and click [Save] to exit.
g. Click [Exit] to exit configuration.

4.1.11 Scan Code Preset

Set the code parameters for barcode reader.

1-dimension barcode reader (1D)

Item Description
Scan Item After scanning 1D bar code, the regular expression is matched in the priority
order: “Patient ID > Other ID > First name > Last name > Middle name >
Accession# > Operator > Diagnostician”. If the regular expression is
matched successfully, the data of 1D bar code will be displayed in this item
in Patient page automatically.
Example: The data of the bar code is 123 after scanning 1D bar code. The
regular expression is matched in the priority order: “Patient ID > Other ID >
First name > Last name > Middle name > Accession# > Operator >
Diagnostician”. If the regular expression of “Other ID” is matched
successfully, “123” will be displayed in “Other ID” item in Patient page
automatically.
Regular Set the regular expression according to the bar code format.
Expression

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Item Description
Append Options The information of operator or diagnostician can be appended after selecting
the check box.
For example, after scanning a 1D barcode of an operator or diagnostician, the
obtained data is A, and A will be displayed in “Operator” or “Diagnostician”
item in Patient page automatically.
After scanning a 1D barcode of an operator or diagnostician for a second
time, the obtained data is B, and A will be appended by B in “Operator” or
“Diagnostician” item in Patient page automatically.
Default Item If the default item is set to “No”, and both the 2D and 1D barcodes fail to be
matched, the obtained data of the barcode is input as a string of characters.
After selecting a default item from the drop down list of “Default Item”, the
obtained data of the scanned barcode will be displayed in the corresponding
selected default item.
For example, if the default item is set to “Patient ID”, and both the 2D and
1D barcodes fail to be matched, the obtained data is displayed in the “Patient
ID” item in Patient page automatically.
Move Up/Down Move up or Move down a selected item.
Add/Delete Add or delete a selected item. (Only the default item can be added or
deleted.)
Load default Restore the parameter value to the default value.
Worklist Options • Select “Worklist server” from the drop-down list, and the system searches
the Worklist server according to the scanned data.
• Select “No” from the drop-down list, and the system creates a new exam
in the Patient page according to the scanned data.
Worklist Default • Select a default item for searching the Worklist server.
For example, users select “Patient ID” from the drop down list of
“Worklist Default”, and the system searches Patient ID in the Worklist
server.
• Select “No”, and the system searches the Worklist server in the priority
order: “Patient ID” > “Last name” > “Accession #”.
NOTE:
The matching priority order is 2D item, 1D item, and Default Item, after
the 1D/2D and default items are configured.
Import/Export Import and export configuration files to preset the barcode. For details,
please contact the Mindray service engineer.

2-dimension barcode reader (2D)

• General Analysis Mode
Select “General” from “Analysis Mode” drop-down list: The scan codes consist of Patient ID,
Other ID, Patient Name, Birth, etc.

Item Description
Scan Barcode Example Input a barcode example, barcode example is separated by separators
(the separator is used to set the start and end position of each item), and
the barcode data is displayed in the following items in turn.

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Item Description
Parameters • Input a barcode example, and you can change the information of
Patient ID, Other ID, First Name, Last Name, Middle Name, Birth
(Day), Birth (Month), Birth (Year), Age, Gender and etc. in the
“Content” list.
Note: Ignore item is used to add one line below the selected item to
hide unimportant patient information.
• Set the start and end position of each item via separators. After
inputting a barcode example, you can select item separators from the
drop-down list of the Separator. (Only separators that are input in the
field box of the Scan Barcode Example can be displayed in the drop-
down list of the Separator.)
Note: You can customize the age unit of Birth (Day), Birth (Month),
Birth (Year) in the Content column. If the DOB provided by the patient
contains only digit, the system displayed an auto-generated age.
Age Unit Select an age unit from the drop-down list of the “Age Unit”: Year,
Month, or Day.
Male/Female Input the customized gender symbol besides the Male and Female field
box, such as Male (M) or Female (F).

• Advanced Analysis Mode

Select “Advanced” from “Analysis Mode” drop-down list: user enters scan barcode example
and regular expression and click [Match], the system will match scan barcode example with
regular expression automatically, and if which is matched successfully, the scan item will
display the barcode by separators.

4.2 Exam Mode Preset

You can assign available exam modes for probes.
Perform the following procedure:
1. To select a probe, move the cursor over the Probe column and select the probe model using the
drop-down list.
2. Select/delete exam modes:
On the left side, you can view all the available exam modes in the exam library for the probe.
On the right side of the screen, you can view the current exam modes assigned to the probe.
– Click [>]: add a selected exam mode in the [Exam mode Library] to the [Probe and Exam
mode] list.
– Click [<]: add a selected exam mode in the [Probe and Exam Mode] to the [Exam Mode
Library] list.
– Click [>>]: add all exam modes in the library to the [Probe and Exam Mode] list.
– Click [<<]: add all probe and exam modes in the library to the [Exam Mode Library] list.
– Click [Delete] to delete a user-defined exam in the Exam Mode Library area.
– Click [Default] to set a selected exam mode as the default exam mode. The default exam
mode is marked by a “√”.

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4.3 Measurement Preset

“Exam Mode XX” on the upper left side refers to the currently configured exam mode. The
configured general/application menus are only related to the current exam mode.
There are three kinds of measurement items.

Measurement
Results of measurements are directly obtained via the measurement tools, which are indicated by
“ ” in the preset screen.
For example, “Distance” in the 2D general measurement or “HC” in the OB measurement.
On the touch screen, measurement tools are displayed using square button.

Calculation
Results of calculations are automatically derived by the system using other measured or calculated
values as parameters, they are indicated by “ ” in the preset screen.
For example, EFW (Estimated Fetal Weight) in the OB measurement.
If all measurements related to a calculation tool are completed, the system will automatically
calculate the result. If some measurement tools are performed again, the system will automatically
update the calculation result using the latest measurement results.
On the touch screen, calculation tools are displayed using square button.

Study
A group of measurements and/or calculations for a specific clinical application, which are indicated
by “ ” in the preset screen.
For example, AFI in the OB measurement.
Fold/unfold the study to hide/show the measurement or calculation items included.
On the touch screen, study items are displayed with an arrow indicating the tools to be selected.

4.3.1 General Measurement Preset

You can preset the General Measurement packages for 2D (B/Color/Power Mode), M Mode, or
Doppler (PW/CW) Mode respectively.
Perform the following procedure:
1. Select the [Caliper] on the [Measure] page.
2. Select the [2D], [M] or [Doppler] tab to go to the corresponding preset menu.
– [Available Items]: general measurement tools configured by the system in the current
scanning mode which are available but not assigned yet.
– [Selected Items]: displays the tools to be added to the menu.
3. Add/Remove the general measurement item using the following buttons:
– [>]: To add the selected tool from the [Available Items] to the [Selected Items].
– [>>]: To add all tools in the [Available Items] to the [Selected Items].
– [<]: To remove the selected tool from the [Selected Items] to the [Available Items].
– [<<]: To remove all tools from the [Selected Items] to the [Available Items]. You do not
need to select any items before removing.
4. Set the default item.
Select an item from the [Selected Items], then click [Default]. The item is marked with a √.
The default item is activated automatically when entering this general measurement menu.

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5. Adjust the item position.

Select an item from the right column and click [Up]/[Down] to adjust the sequence in which
the items are arranged in the corresponding general measurement menu (touch screen display).
6. Modify the properties of a measurement item.
The following takes D trace as an example to show how to set the properties of a measurement
tool.
a. Select the [Doppler] tab to go to the corresponding preset menu.
b. Select [D Trace] from the [Selected Items] and click [Property] to bring up the following
dialog box.

Descriptions of the attributes are shown in the following table:

Item Description
Item Name & Result Results obtained from D trace are listed. The selected items will be
displayed in the results window after measurement.
• If PV is selected, other results become deselected (except the
temporary result “velocity”).
• Some results, such as PS and ED, can be derived via a simple
method (e.g., Velocity), but others, such as TAMAX, can only be
derived via complicated methods such as Manual, Spline, Auto, etc.
• Only Vel. is available in [Method] if only PS or ED is selected.
• Methods for obtaining PS and TAMAX simultaneously (trace, spline
and auto) should be chosen if both PS and TAMAX are selected
(TAMEAN should use auto method).
Unit Select the measurement unit.
Click “Unit” column of each item to select.
CalcMethod Select the measurement method for the tool.
Click “CalcMethod” column of each item to select.

c. Click [OK] to confirm the setting.

7. Select the measurement sequence.
– [Repeat]: after the current measurement is completed, the system automatically activates
the current tool again.

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– [Next]: after the current measurement is completed, the system automatically activates the
next tool in the menu.
– [None]: after the current measurement is completed, the cursor can be moved over the
whole screen. And the cursor will automatically return to the menu of the corresponding
measurement.
8. Click [OK] to confirm.

4.3.2 Application Measurement Preset

Measurement Package Preset
During measurement, the preset package displays on the touch screen. Items in the package can be
preset and may belong to different application regions.
You may configure more than one measurement package for current exam mode. Under actual
measurement status, switch the measurement library if necessary.
Click [Advanced] on the [Measure] page to enter the “Add New Package” page.
• [Available Items]: shows application packages configured in the system but not yet assigned to
the current mode.
• [Selected Items]: shows application packages assigned to the current exam mode. If more than
one package is assigned to the current exam mode, you can rotate the knob under the [Library]
button on the touch screen or clicking menu title in the measuring status.
Package editing includes Creating Packages, Add/Remove Items, Deleting Measurement Packages,
Setting Default Packages, Adjusting Package Positions.
• Creating Packages: Click [New] and enter a name for the new package in the dialog box pop-
up. Click [OK] to confirm, the new package displays in the [Available Items] list.
• Adding/Removing Packages: Add/remove the package by clicking [>], [>>], [<] and [<<].
• Deleting Packages: Select a package from the [Available Items] list, click [Delete]. To delete
an item from [Selected Items], you need to move it to the [Available Items] first.
• Setting Default Packages: Select a package from the [Selected Items] list, then click [Default].
The default package is marked with a √.
The default package displays when entering the [Measure] page.
The measurement menu of the default package (corresponding to the exam mode) displays
when entering the measuring status.
• Adjusting Package Positions: Select a package from the [Selected Items] and click [Move Up]/
[Move Down] to adjust the sequence that the packages in the menu are arranged in.

Measurement Menu Preset

The following operations are available.
• Adding/Removing Items: Add/Remove the general measurement item using the [>], [>>], [<]
and [<<].
• Setting Default Items: Select an item from the [Selected Items] list, click [Default]. The
defaulted item is marked with a √.
To deselect the default tool, select it and click [Default] or set another item as the default.
If a particular item is set as the default item, it automatically displays the submenu of the study
when entering this measurement menu.
• Adjusting Item Positions: Select an item from the [Selected Items], click [Move Up]/[Move
Down].
The order in the list is also the item position in the menu.

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User-defined Measurement/Calculation/Study

NOTE:
• Please ensure the correctness and validity of the defined formula, otherwise Mindray will not
be liable for damage caused by improper definition of the formula.
• Trigonometric functions are in degrees, not radians.
• PI is accurate to 7 digits.
• Adding B-Hist or B-Profile to the study is not supported.
• Click [Export Custom] in the measurement preset window to export the user-defined
measurement.

User-defined Measurement
Perform the following procedure:
1. In Measure page, select [New], the “Measurement Custom Wizard” dialog box appears.
2. Enter the Name in the “Measurement Custom Wizard” dialog box, and select Add Meas.
The “Measurement Custom Wizard” dialog box appears, as shown in the following figure.

3. Select [Next] to Step 2. Select the [Tool Type], [App Region] and the Measurement Result.
Descriptions of the attributes in the dialog box are shown in the following table.

Attributes Descriptions
App Region Select the application region for the user-defined item.
Tool Type General measurement tool type of the user-defined item. E.g. Select
Dist. if you want to add a new item to measure the distance.
Has Left-Right If selected, you can choose left or right side in the measurement menu.
Has Prox-Mid-Dist If selected, you can choose proximal, middle or distal in the
measurement menu.
Measurement Result Choose the results to be displayed in the results window. The result
name can be changed.
Move the cursor over an item, then enter the name in the text box.

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Attributes Descriptions
Unit Select the measurement unit.
Select “Unit” column of each item to select.

4. Select [Complete] to finish setting. The user-defined measurement item is listed in the
“Selected Items” menu and in the “User-defined” category of “Available Items.” An asterisk
appears after the user-defined item for identification.
In the meantime, the user-defined item will be added automatically to the “Selected Items” in
the Report template. If the item is completed in an exam, the results will be displayed in the
report.

User-defined Calculations
User-defined calculations are derived from arithmetic operations in which the parameters are
measurement, calculation or study results obtained in measurement items which exist in the system
or are user-defined.
Perform the following procedure:
1. In Measure page, select [New], the “Measurement Custom Wizard” dialog box appears.
2. Enter the Name in the “Measurement Custom Wizard” dialog box, and select Add Calc.
3. Select [Next] to Step 2. Select the [App Region] and edit the formula.
Descriptions of the attributes in the dialog box are shown in the following table.

Attributes Descriptions
Formula Displays the user-defined formula.
Verify Used to verify if the formula is valid.
Application Region Select the application region for the user-defined item.
Measurement Item All available measurement items of the application region selected in
the previous step.
Calculator/Function You can select from measurement/calculation/study items in 2D/M/
Doppler mode.
Unit Used to enter numbers and functions in the formula.

For example, to create a user-defined measurement item (HC/AC):

a. Enter name for the item, such as “calculation 1.”
b. In Region select “Obstetric,” then select the measurement tool sources “2D” and
“Measurement.”
c. Find HC in the “Item Name” list, click to select it, then double-click HC in the Result
Name box on the right side. The index is added to the formula.
d. In the Calculator, click “/” and it is added to the formula.
e. Find AC in the “Item Name” list, click to select it, then double-click AC in Result Name
box on the right side. The index is added to the formula.
The function description is as follows:

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Function Method Parameter Number Function Description

sin sin(a) 1 Sine (the ratio of the opposite to the
hypotenuse)
cos cos(a) 1 Cosine (the ratio of the adjacent to
the hypotenuse)
tan tan(a) 1 Tangent (the ratio of the opposite to
the adjacent)
atan atan(a) 1 Arctangent (the result is expressed in
radian.)
min min(a,b,...) ≥2 Minimum
max max(a,b,...) ≥2 Maximum
sqrt sqrt(a) 1 Square root
pow pow(a,b) 2 Calculate b power of a
exp exp(a) 1 Exponential function with natural
constant e as the base
ln ln(a) 1 Logarithm with natural constant e as
the base
log log(a) 1 Logarithm with 10 as the base
avg avg(a,...) ≥1 Average value
abs abs(a) 1 Absolute value
PI PI / Constant π, 3.1415926
NOTE:
The letter “a” and “b” in the “Method” Column are parameters.

The following physiological indicators can be added to the formula.

Name Definition Unit

Age Age day

BSA Body surface area m2
PSA Prostate specific antigen ng/ml
PPSA Coefficient PPSA Coefficient ng/ml2
RAP Right atrial pressure mmHg
GA Gestational age day
Height Height cm
Weight Weight kg
Heart Rate Heart rate bpm
High BP(CAR) High blood pressure (Cardiac) mmHg
Low BP(CAR) Low blood pressure (Cardiac) mmHg
High BP(VAS Left) High blood pressure (Left Vessel) mmHg

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Name Definition Unit

Low BP(VAS Left) Low blood pressure (Left Vessel) mmHg

High BP(VAS Right) High blood pressure (Right Vessel) mmHg
Low BP(VAS Right) Low blood pressure (Right Vessel) mmHg

4. Verify the formula, select the unit of the result, then select [Complete]. The user-defined
calculation item is listed in the “User-defined” category of “Available Items.”
In the meantime, the user-defined item will be added automatically to the “Selected Items” in
the Report template. If the item is completed in an exam, the results will be displayed in the
report.

User-defined Study Items

Perform the following procedure:
1. In Measure page, select [Add Study].
2. Enter the study name in the dialog box that appears.
3. Select [OK] and the item will be added to the “Selected Items.”
4. Select a measurement/calculation item from the “Available Items” and select [>] to add the
item to the user-defined study.

Add a Study
You can add or remove user-defined study items in the [Selected Items] column.
Perform the following procedure:
1. Select the [Measure] tab page.
2. Click [Add Study] on the right.
3. Enter the study name in the dialog box that appears.
4. Click [OK] and the item will be added to the “Selected Items.”
5. Select a measurement/calculation item from the “Available Items” and click [>] to add the item
to the user-defined study.
6. Repeat the step 5 to add more items if necessary.
7. Move the cursor to click on the study and click [Property] on the right to edit the measure
sequence.

Edit User-defined Items

Select the target defined item in the “Available Items”, and click [Edit].

Remove User-defined Items

• Remove Measurement/Calculation
a. Select “User Defined” in the “Available Items”, and select the desired item.
b. Click [Delete].
• Remove Study
Select a user-defined study, click [<].

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4.3.3 Report Preset

NOTE:
• Deleting is not supported in IVF, IMT and EM reports.
• Watch the layout when setting the patient information layout of the report template. Do not set
too many characters in one line; otherwise it may affect the display of the report.

Creating Report Templates

Perform the following procedure:
1. Select the [Report] on the [Measure] page.
2. Click [New] to bring up the following dialog box.
3. Select template: click the drop-down list under “Application Region” to select the template
and click [OK] to confirm the template layout and exit the dialog box.
4. Enter the name for the user-defined report template in the box after “Report Template Name”.
5. Click [Measurement] to select measurement results to be displayed in the report:
a. Select an application category from the drop-down list beside “Available Items”.
b. Select Measurement, Calculate, Study or All from the drop-down list beside “Available
Items”. The corresponding items appear in the list.
c. Use the [>] or [>>] buttons to add items to the “Selected” list.
Only tools which appear in the right column and are completed in the ultrasound exam
can be displayed in the report.
In cardiac mode, if result items of only one formula are selected, only results of that one
formula will be displayed after measurement. (For e.g., if only items suffixed with
Teicholz are selected, not with Gibson or Cube, then only results suffixed with Teicholz
after measurement are displayed.)
d. Add the study.
Click [Add Study] and enter the study name in the dialog box which appears, then click
[OK].
The new added study appears in the “Selected” list.
e. Adjust the item position.
Select an item from the “Selected” list, click [Up]/[Down] to adjust the position of the
item in the list, as well as in the report template.
f. Click [OK] to save the settings and exit the dialog box.
6. Set the module display in the report: click [Setting] to make a selection;
– Tick the check box in front of the module name to display the module in the report;
– Click [OK] to save the setting and exit.
7. Change the patient information layout in the report template:
– Change the template used in the report layout: click [New Layout] to select another
template.
– Double click the information lines to be edited in “Report body”. The dialog box of font
setting appears. Set the font size, font weight or hidden key words.
– Double click the blank of a module in “Report Body”. The dialog box of editing the
content appears. Select the content to be displayed at current position.
– Press left <Set> key on the blank of a module in “Report Body”. Choose to add or delete
the line, or add the table, etc.

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8. Click [Save] to save the setting.

9. Click [Close] to quit the template.

Deleting Report Templates

Perform the following procedure:
1. Select the [Report] on the [Measure] page.
2. Select the template to be deleted from the list.
3. Click [Delete] > [Yes] to delete the selected template.
4. Click [OK] to confirm the settings.

Editing Report Templates

Perform the following procedure:
1. Select the [Report] on the [Measure] page.
2. Select the template to be modified from the list.
3. Select [Edit] to enter the [Measurement Report Preset] dialog box.
4. Click [OK] to confirm the settings.

Setting Default Templates

Perform the following procedure:
1. Select the [Report] on the [Measure] page.
2. Select a report template from the list.
3. Click [Default].
4. Click [OK] to confirm.

4.4 Comment Preset

You can preset the custom comments library for current exam mode. The comments in the library
are provided by the system or user-defined ones.

4.4.1 Comment Configure

Add a user-defined item
Directly enter user-defined comment texts: posit the cursor in the field box above [Add Comment],
enter the text comment through the soft keyboard, and then click [Add Comment]. Then the
directly-entered comment will be added to the Selected Items.

Select available items

Perform the following procedure:
1. Select available items:
a. Select a comment library in the drop-down list below “Application”.
b. Select a comment type in the drop-down list below “Type”.
All items will be displayed below “Available Items”.
2. Click [>], [>>], [<] and [<<] to add the item in Available Items on the left into Selected Items
on the right.

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TIP:
You can only delete the user-defined items rather than the items in the system library. After a user-
defined item is deleted, it will not be available.

Change position of the selected items

Select an item on the right side box and click [Up], [Down], [Left] or [Right] button to change the
position of the item.

4.4.2 Comment Group Define

Add user-defined group
Enter user-defined group name in the name text box below [Lists Name] through the soft keyboard,
click [Add Group]. The entered group name will be added to the Group Lists.

Add comment items to the user-defined group

Perform the following procedure:
1. Select a user-defined comment group from the “Group Lists”.
2. Do one of following to add comment items:
– Select a comment library in the drop-down list below “Application”: Select a comment
item, click [>] to add it into Selected Items on the right; click [>>] to add all items into
Selected Items on the right directly
– Add user-defined comment item: Enter user-defined comment in the name text box above
[Add Comment] through the soft keyboard, click [Add Comment]. The entered comment
item will be added to the Selected Items.

Change position of the selected items

Select an item and click [Up], [Down] button to change the position of the item.

Delete a comment item from user-defined group

Select an item in the Selected Items, click [<].

TIP:
You can only delete the user-defined items rather than the items in the system library. After a user-
defined item is deleted, it will not be available.

4.5 iWorks Preset

You can customize the protocols and views in the iWorks preset screen.

4.5.1 Protocol Management

• Click to select the protocol in the list. The protocol type can be checked on the right.
• Click [Add Protocol] to create a new protocol. It can be customized.
• Click to select a protocol in the list on the left and click [Copy]. A protocol named
“XXX_Copy1” is created with the copied views, which can be customized.
• Select a view with “Left”, “Lt”, “Right” or “Rt” in its name in the list on the left, and click
[Copy L<>R]. The selected view is copied onto a new view in which bodymarks, annotations
and measurement items are reversed to the opposite side.

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• Click [Delete] to delete a user-defined protocol.

• Click [Up] or [Down] to move the selected protocol.
• Click [Move to Top]/[Move to Bottom] to move the selected protocol to the top or bottom of
the list.

4.5.2 View Management

• Click to select the views in the list. The image, annotation, body mark and measurement
settings can be checked on the right.
• Click to select a user-defined protocol in the list. Click [Add View] to add a view template to
the protocol.

4.5.3 Create a New Protocol

You can create user-defined protocols and customize the automated procedure.
Perform the following procedure:
1. In the iWorks preset screen, click [Add Protocol] to create a new protocol.
Or, select an existing protocol and click [Copy] to customize the protocol based on the
previous template.
2. Enter the protocol name, type and select the application region.
3. Click [Add View] to enter the view name and perform image settings.
– To set PW Angle Correction, you can select [Default/Last Use] to keep the angle of a
newly-created view the same as that of the last view.
– In the measurement setting, if “Measurement on next section” is selected, the system will
save two section images after finishing the section operation. One of the two sections will
include the measurement result.
– Select the checkbox of “Disable Protocol Body Marks” for body mark display settings.

4.6 Stress Echo Preset

4.6.1 Protocol Edit
You can create, edit, delete, copy, export and load the Stress Echo protocols using the Protocol
Editor dialog box.

Item Description
Protocol Name Enter the protocol name.
Trigger Set the trigger type.
WMS model Set the chamber segment division method.
Loop usage Displays the acquired loop number as well as the total usable loop number.
View Set the views for each stage.
Standard Views Set the standard view.
Load Import a protocol.
Export Export a protocol.
New Protocol Create a new protocol.

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Item Description
Copy Protocol Create a new protocol with an existing one.
Delete Protocol Delete the protocol.
New stage Create a stage for the current protocol.

Creating a Stress Echo Protocol

Perform the following procedure:
1. Click the [New Protocol] to the right of the Protocol Editor dialog box.
2. Enter the protocol name in the Protocol Name box at the top.
3. For each view (all views display for each phase):
a. Select “New View” in the View list.
b. Select a standard view from the Standard View list. Or you can customize the view name.
4. For each phase in the protocol:
a. Select “New Stage” in the Stage list.
b. Enter a phase name.
– Select “Auto Select”, the system jumps to Select Mode after retrospective acquisition.
– Select the required option from the Clip Capture drop-down list.
– Select the number of loops to acquire (per view in the selected phase) in the Loops list (for
non-continuous stages).
– Select the type: exercise or drug.
5. Click [OK] to save changes and quit.

Editing a Stress Echo Protocol

Perform the following procedure:
1. Click a user-defined protocol on the Select Protocol screen.
2. Edit the protocol as described in the create protocol.

Deleting a Stress Echo Protocol

Click an user-defined protocol on the Select Protocol screen, click [Delete Protocol].

4.6.2 Maintenance

Item Description
Acquire mode Set the type of ROI: manual ROI or full-screen.
Overlay Select the items to be labeled on each loop.
WMS score type Set the chamber segment division method.
QT-Time table To customize the length of systolic duration acquired for a specific heart
rate, it will store the clip duration. You can add and remove entries in
this table. You can also load the factory defaults.
Heart rate Enter the heart rate.
Syst. duration Enter the systolic duration.
Load factory To reset the QT time table.

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4.7 DICOM/HL7
4.7.1 DICOM Local Preset
TIP:
• AE Title should be the same with the SCU AE Title preset in the server (PACS/RIS/HIS), for
example, if the AE Title of the server preset in the storage server is Storage, and the AE Title of
the accepted SCU is preset as Machine, then in the figure above, the AE Title of Local should
be Machine, and the AE Title of storage server should be Storage.
• The device name is random. If the server name is same with that in the DICOM server list, the
information “the server added already exits”, click [OK] to retype the name.
• IP address should be the address of the remote server.

DICOM local preset items are described as follows:

Item Description
Local Host AE Title Application Entity title.
DICOM
Port Communication port, DICOM communication port.
service
property PDU Maximum PDU data package size (not need to change),
ranging from 16384 to 65536; if the value is less than
16384 or greater than 65536, the system automatically
sets it to the value 32768.
DICOM output Select an character set for DICOM output according to
charasets the local PACS workstation.
Transcoding elements Set what DICOM element(s) will be transcoded.
TLS Port Set the TLS port.
TLS Server Setting Import the encryption key/certificate.
TLS Client Setting • After importing TLS certificates, and selecting Verify
Certificate check box, the system verifies the
effectiveness of the TLS function in the DICOM
storage, print, and worklist services.
• Import trusted certificates, or delete certificates.
Server Setting Device Name of the device supporting DICOM services.
IP Address IP address of the server.
Ping You can ping the other machines after you entered the
correct IP address.
Besides, you can select a server in the Device list to ping
it.
Device List Displays the added device.
Set DICOM Service Provides server settings of DICOM service, for details,
please refer to the following chapters.
Set DICOM Strategy Click to enter the configure the strategy screen.
Log Level For engineer use only.
Capture

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Add a Server
Perform the following procedure:
1. Enter the server device name and IP address.
2. Click [Ping] to check the connection.
3. Click [Add] to add the server to the device list, and its name and address are displayed in the
list.

Delete a Server
Select a server in the device list, and then click [Delete].

Set DICOM Strategy

TIP:
• The DICOM strategy must be configured by qualified personnel with good knowledge of
DICOM standards.
• The qualified personnel must ensure the validity of the DICOM strategy.

Perform the following procedure:

1. Click [Set DICOM Strategy].
2. Edit the DICOM strategy:
– Add: Enter strategy name and description, and click [Add] to add a new strategy. Then the
added strategy will be added to the Strategy List.
– Delete: Select a strategy from the Strategy List, and click [Delete].
– Update: Select a strategy from the Strategy List, re-enter strategy name or description, and
click [Update].
3. Configure the item:
Select a strategy name from the Strategy List, and assign strategy items to the selected strategy.
– Add: Set the function from the drop-list box, enter the parameter 1 and parameter 2, and
click [Add]. Then the added strategy item will be added to the Strategy Items List.
– Delete: Select a strategy item from the Strategy Items List, and click [Delete].
– Update: Select a strategy from the Strategy Items List, reselect the function or re-enter the
parameter 1/2, and click [Update].
4. Import/Export strategy:
– Import: Click [Import], browse the desired strategy file and operate according to the
screen prompts to import.
The imported file for DICOM strategy must be a *.xml file.
– Export: Select a strategy from the Strategy List, click [Export] and then select the export
path and type the file name.
E drive is default, and the file type is .xml.

4.7.2 DICOM Service Preset

The DICOM Service screen is used to set attributes for DICOM service.
When the system is configured with DICOM basic function module, and installed with DICOM
modules, the corresponding preset can be found in DICOM Service screen.

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TIP:
Not all SCPs can support verification. See the SCP properties to confirm whether the SCP can
support this service. If not, the verification will not be successful.

Perform the following procedure:

1. Click [Set DICOM Service] on the DICOM/HL7 screen.
2. Select the DICOM service tab to enter the corresponding settings screen.
3. Enter the correct AE Title, port, etc.
– Click [Add] to add the service to the Service List.
– Select an item in the service list, change the parameters in the above area, and click
[Update] to update the item in the service list.
– Click to delete the selected service in the service list.
– Select an item in the service list, click [Default] and you can see “Y” in the Default
column.
4. Click [Verify] to verify that the two DICOM application entities are properly connected.
If the verification is successful, the system displays “xxx Verify Succeed.” Otherwise, it
displays “xxx Verify Failed.”
If verification failed, possible causes may be: wrong IP address, not able to access IP address,
remote DICOM server is not running, wrong port, incorrect application name.

Storage Service Preset

DICOM storage preset items are described as follows:

Item Description
Device After you set the server (s) in DICOM Preset screen, the name (s) will
appear in the drop-down list, select the name of the storage server.
Service Name Default is xxx-Storage, user-changeable.
AE Title Application Entity title, here, it should be consistent with that of the storage
server.
Port DICOM communication port, 104 is default. Here, the port should be
consistent with that of the storage server port.
Maximum Retries Set the maximum retries (0-9). The default value is 3. If the DICOM task
sending to the server fails, the retry times should be 3.
Interval Time(s) Interval time.
Timeout Refers to the amount of time after which the system will stop trying to
establish a connection to the service.
TLS Transport Layer Security. Select whether to encrypt the data during network
transportation.
Cine Zoom Mode Select the cine zoom mode during image file storage.
Compression Mode Select the compression mode: original data (uncompressed), RLE (the
image not compressed), JPEG, and JPEG2000.
Compression Ratio Select the JPEG compression ratio: lossless, low, medium, and high.
The compression ratio is inversely proportional to the image quality
(reserved function).

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Item Description
Color Mode Select the color mode.
If you choose the mix or the grey, RLE/JPEG is unavailable.
The image uses 24 bit when sending the image from the ultrasound device to
the server; it depends on the image when choosing the mix. The image use 8
bit if the image is captured in color mode or the image has the tint. All
images use 8 bit when choosing the grey.
Allow Multiframe If SCP supports this function, then select it.
Max Frame Rate Set the frame range of transferring cin file into DCM multi-frame file. It is
editable to the user.
3D/4D Set the 3D/4D image transfer mode.
Set the transfer mode for the 3D/4D cine sending.
• Normal: use the way that 2D image adopts to send;
• Volume: use Enhanced US Volume Storage IOD to send;
• Data source: used to obtain 3D/4D image for 4D Viewer.
SR Storage Option To enable or disenable structured reporting sending.
Encapsulated PDF Select if to encapsulate PDF format report in DICOM standard.
It becomes available if SCP supports the function.
Doppler audio Set to save the audio of PW mode.
Storage mode Set the storage mode for image and cine file:
• Parallel file: save the current file, and is ready for the storage of the next
file.
• Parallel frame: send the current frame, and is ready for sending the next
frame.
TransducerTracking Files of images that are saved in DCM format through DICOM or
DICOMDIR contain transducer serial number information.
Strategy Name Set the DICOM strategy.

TIP:
• If the server software supports the compression algorithm, select JPEG, RLE, JPEG2000.
Otherwise, original data should be used (RLE is the default method).
• RLE, JPEG and JPEG2000 are not supported by all SCPs. Refer to the SCP’s DICOM
CONFORMANCE STATEMENT electronic file to check whether SCP supports it or not. Do
not select these compression modes if the storage server does not support them.
• Images of PW/M/TVM/TVD mode (B image is not frozen) and images other than PW/M/
TVM/TVD mode: if “Max Frame rate” is not “Full” and the actual frame rate is larger than the
set value, the system will save the image files in a frame rate of the set value, and transfer in a
frame rate of B mode.
• Images of PW/M/TVM/TVD mode (B image is frozen), the system will save/transfer the
images files in frame rate of 6.

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Print Service Preset

DICOM print preset items are described as follows:

Item Description
Device After you set the server (s) in DICOM Preset screen, the name (s) will
appear in the drop-down list, select the name of the print server.
Service Name Default is xxx-Print, user-changeable.
AE Title Application Entity title, here, it should be consistent with that of the
print server.
Port DICOM communication port, 104 is default. Here, the port should be
consistent with that of the print server port.
Maximum Retries It starts retrying if it fails to send DICOM task to the server. The retry
entry times should be this value.
Interval Time (s) Reserved time.
Timeout Refers to the amount of time after which the system will stop trying to
establish a connection to the service.
TLS Transport Layer Security. Select whether to encrypt the data during
network transportation.
Copies Refer to copies of printed files. You can select among 1 through 5, or
directly enter the numeral.
Settings The system supports RGB (color printing) and MONOCHROME2
(black and white printing). Please select the type the printer supports.
Film Orientation Select between LANDSCAPE and PORTRAIT.
Priority Specify printing task priority among HIGH, MED and LOW.
Film Size Select film size among the selections listed in the drop-down list.
Display Format Specify quantity of printed files, e.g. STANDARD\2, 3 indicates 6
images are printed for each page.
Medium Type Specify print medium: Paper, Clear Film, Blue Film; select Blue Film
or Clear Film for black and white printing; select Paper for color
printing.
Trim Specify whether you want a trim box to be printed around each image
on the film: Yes or No.
Configuration Info Enter configuration information in the field.
Min Density Enter the minimum density of the film.
Max Density Enter the maximum density of the film.
Destination Specify where the file is exposed: MAGAZINE (stored in the
magazine), or, PROCESSOR (exposed in the processor).
Magnification Type Select how the printer magnifies an image to fit the film.
• Replicate: interpolated pixels belong to duplicate of adjacent pixels);
• Bilinear: interpolated pixels are generated from bilinear
interpolations between adjacent pixels;
• Cubic: interpolated pixels are generated from cubic interpolations
between adjacent pixels;
• None: without interpolation.

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Item Description
Strategy Name Set the DICOM strategy.

Worklist Setting
DICOM service setting for Worklist is described as follows:

Item Description
Device Name After you set the server (s) in DICOM Server Setting screen, the name
(s) will appear in the drop-down list, select the name of the Worklist
server.
Service Name Default is server-Worklist, and it can be modified.
AE Title Application Entity title. It is consistent with that of the Worklist server.
Port DICOM communication port, 104 by default. The port should be
consistent with that of the Worklist server port.
Maximum Retries Reserved feature.
Interval Time(s) Reserved feature.
Timeout Refers to time after which the system will stop trying to establish a
connection to the service.
TLS Transport Layer Security. Select whether to encrypt the data during
network transportation.
Strategy Name Set the DICOM strategy.
Remove Attributes(0) Set what DICOM element(s) that will not be used in worklist query.

MPPS Preset
MPPS setting items are described as follows:

Item Description
Device Name After you set the server (s) in DICOM Server Setting, the name (s) will
appear in the drop-down list, select the name of the MPPS server.
Service Name Default is server-MPPS, and it can be modified.
AE Title Application Entity title. It should be consistent with that of the MPPS
server.
Port DICOM communication port, 104 by default. The port should be
consistent with that of the MPPS server.
Maximum Retries It starts retrying if it fails to send DICOM task to the server. The retry
entry times should be this value.
Interval Time(s) Reserved feature.
Timeout Refers to the amount of time after which the system will stop trying to
establish a connection to the service.
TLS Transport Layer Security. Select whether to encrypt the data during
network transportation.

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TIP:
Set the MPPS service as the default when using the MPPS.

Storage Commitment Setting

DICOM storage commitment setting items are described as follows:

Name NOTE
Device Name After you set the server (s) in DICOM Server Setting, the name (s) will
appear in the drop-down list, select the name of the storage commitment
server.
DICOM Service Name Default is server-SC, and it can be modified.
AE Title Application Entity title. Here, it should be consistent with that of the
storage commitment server.
Port DICOM communication port, 104 by default. Here, the port should be
consistent with that of the storage commitment server port.
Maximum Retries Reserved feature.
Interval Time(s) Reserved feature.
Timeout Refers to the amount of time after which the system will stop trying to
establish a connection to the service.
Associated Storage The associated storage server is preset before storage commitment, only
Service after the exam is sent out, can storage commitment be created.
TLS Transport Layer Security. Select whether to encrypt the data during
network transportation.

Query/Retrieve
DICOM query/retrieve setting items are described as follows:

Item Description
Device Name Select the name of a device that can be added (including the local).
Service Name Default is server-queryRetrieve, and it can be modified.
AE Title Application Entity title.Here, it should be consistent with that of the
storage commitment server.
Port DICOM communication port, 104 by default.Here, the port should be
consistent with that of the storage commitment server port.
Maximum Retries Reserved feature.
Interval Time(s) Reserved feature.
Timeout Refers to the amount of time after which the system will stop trying to
establish a connection to the service.
TLS Transport Layer Security. Select whether to encrypt the data during
network transportation.

HL7 Query Service Preset

The protocol version that the ultrasound system supports: V2.3, V2.4, V2.5, V2.6.

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HL7 service setting for Worklist is described as follows:

Item Description
Device Name After you set the server (s) in DICOM Server Setting screen, the name
(s) will appear in the drop-down list, select the name of the Worklist
server.
Service Name Default is server-HL7Query, and it can be modified.
AE Title Application Entity title.here, it should be consistent with that of the
HL7 server.
Port DICOM communication port, 104 by default.Here, the port should be
consistent with that of the HL7 server port.
Maximum Retries Reserved feature.
Interval Time(s) Reserved feature.
Timeout Refers to the amount of time after which the system will stop trying to
establish a connection to the service.
Listen mode This function enables the ultrasound system to use the listen port for
data receiving.
Listen port Port for ultrasound system to receive data after the listen mode function
is activated. Here, the port should be consistent with that of the HL7
server port.
For details of listen port setting, refer to settings in the server.

4.8 Network Preset

4.8.1 Network Settings
Transmission Encryption
After accessing the network, click [VPN Config] to enter the “VPN Config” interface.

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Item Description
Status • No driver: click [SetupDriver] to enter the “TAP-Windows 9.21.2
Setup” interface, and do as instructed.
• Ready: the VPN is ready for use.
• Advance: VPN Advance Configuration
• Connected: VPN is successfully connected.
• Disconnected: VPN is disconnected.
• Error: error connection.
Server IP /
Group /
User Name /
Password /
Hide characters The password is displayed as *.
Connect/ Disconnect Connect or disconnect VPN.
Advance Enters the “VPN Advance Config” interface.
• Reset: if the system does not respond after you click [Config], click
[Reset].
• Config: enters the “OpenConnect-GUI VPN client” interface. For
details about the settings, please refer to the TAP manual.
NOTE:
After exiting the “VPN Advance Config” interface, you need to
reboot the system; otherwise, you cannot connect VPN normally.
Close Close the “VPN Advance Config” interface.

Turn on Wi-Fi function

1. Select [Network Settings] page in Network Preset screen.
2. Confirm the Wi-Fi is enabled: [Disable Wifi] appears on the screen.

Turn on hosted network function

Reserved.

4.8.2 iStorage Preset

You can send exam data or images to the iStorage server and perform analysis using UltraAssist.
For details about this feature, see the UltraAssist manual.

Item Description
Service Name The name of the iStorage service.
IP Address IP address of the iStorage service device.
Port Port for transmitting.
Charset Set the character set.

Add an iStorage service

Perform the following procedure:

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1. Set the iStorage server properties as described above.

2. Click [Connect] to verify connection.
3. Click [Add] to add the service to the Service list.

Edit a network service

Perform the following procedure:
1. Select the service to be updated in the service list.
2. You can see properties in the Configure Service area.
3. Do one of the following to edit the network service:
– Modify the properties and click [Update] to update the setting.
– Click [Default] to set as the default service.
– Click [Delete] to delete it from the service list.

4.8.3 MedTouch/MedSight Preset

You can set environment for MedTouch/MedSight here and then use the MedTouch/MedSight
function by mobile phone or tablet computers. See MedTouch/MedSight manual for details.

4.8.4 Remote Maintenance

NOTE:
• After the remote maintenance permission is enabled, it indicates that the ultrasound equipment
permits remote access from the remote controller to upgrade the equipment, transmit files, or
check and download logs.
• Once enabled, the remote maintenance permission is enabled by default after restarting the
ultrasound equipment.

Perform the following procedure:

1. Select [Remote Maintenance Permission].
2. Select [Upload logs to remote server] to upload logs to the remote server, Mindray service
engineers can acquire and handle those log.
Check the process in “Task Management” screen.

4.8.5 Q-Path Preset

You can use the ultrasound system to check data on browser directly. After you have ordered
storage service of a network website service, you can check data using the website, authorized
account and password (provided by the service vendor). You can open the browser (Q-View) to
review previously sent DICOM data.
Q-path is a network server provided by Telexy Healthcare Inc. for digital image storage. Q-View is
a client viewing tool for the server. Telexy Healthcare developed technology and a command
structure that allows any Q-view enabled ultrasound system to access Q-path directly from the
ultrasound system using a single control. The primary purpose for Q-view is to provide remote
access to Q-path from the ultrasound system to complete the exam report on the ultrasound system
and submit for QA.
To access Q-Path on the system, the user just opens the Q-View first and then enters the URL, user
account and password provided by Telexy Healthcare, and the system software system will call Q-
View tool then for user Q-Path application.
For details, please contact Q-Path service provider.

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Q-Path Basic Preset

Item Description
Advanced Sets the sub URLs of “QView full” and “QView lite”.
The sub URL is set by default. Users can modify the sub URL and click
[Apply] to exit the “QView sub URL setting” window.
Enable Direct Report Sets whether to open the Q-Path server through the [Report] key.
Worksheet Only Sets whether to directly enter the Worksheet interface after opening the
Q-Path server.
Password On Worksheet Sets whether to display the Signature field box in a worksheet.
Tap [Report] > [WorkSheet] or tap [Review] > [Report] > [WorkSheet],
enter the worksheet password in the field box, and click [OK].
Users can query the corresponding worksheet by searching the
worksheet password in the Q-Path server.
Password On End Exam Sets whether to input the worksheet password after ending an exam.
Password Visible Sets whether the password is visible.
Import Imports a user-defined worksheet template from the USB storage
(downloaded from the Q-Path server).
Backup Backs up worksheets to the USB storage.
Restore Restores the backup worksheet template from the USB storage to the
ultrasound system.
Delete Deletes a worksheet template.
Restore Factory Restores the worksheet template to the default state.

Perform the following procedure:

1. Select “Enable Q-Path”.
2. Enter the website, account and password of the target service.
3. Select user type: Personal User or Default User.
– Personal User: the personal user needs to enter the user name and password in every-time
login.
– Default User: after the default user enters the user name and password in the field box of
the “User Name” and “Password”, and click [OK], no login is required to access the Q-
Path server later.
4. Select an appropriate item from the drop-down list of “Available Items”.
5. Select an exam mode in the left “Exam Mode” column.
6. Select a worksheet in the right “Worksheets” column.
7. Click [OK] to exit, and the system will shut down.

4.8.6 eGateway Preset

Before using eGateway, the system should be in the same network segment with the eGateway
server, and ensure that the eGateway software version is 7.1 or later versions.
For details of eGateway installation and configuration, see eGateway manual.

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eGateway Query

Item Description
Service Name The name of the eGateway service.
IP Address Input the ADT Source IP address in the eGateway Server configuration
interface.
Port Input the MAQ Server Port in the eGateway Server configuration
interface.
Clear Click to cancel the parameter setting.
Add Click to add the Network service to the service list.
Update Select an item in the service list, change the parameters in the above
area, and click [Update] to update the item in the service list.
Delete Click to delete the selected service in the service list
Default Set the eGateway server as the default.
Select an item in the service list, click [Default] and you can see “Y” in
the Default column.
Connect Click to verify whether the connection is normal.

To add an eGateway service

1. Set the eGateway server properties as described above.
2. Tap [Add] to add the service to the service list.
To modify a network service
1. Select the service to be updated in the service list.
2. Modify the parameters in the upper part of the screen and tap [Update] to update the setting.

eGateway Store
Before using the eGateway storage, ensure the Send Mode is set to “MDM with Reference” in the
eGateway Server configuration interface.

Type Item Description

Configure Service Service Name The name of the eGateway service.
MultiBackend IP Address Input the ADT Source IP address in the eGateway
Server configuration interface.
Port /
DocServer IP Address Input the ADT Source IP address in the eGateway
Server configuration interface.
Port Input the Document Sharing SSL Port in the
eGateway Server configuration interface.
Image/Cine/PDF Set the shared document content.
Report

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Type Item Description

/ Clear Click to cancel the parameter setting.
Add Click to add the Network service to the service list.
Update Select an item in the service list, change the
parameters in the above area, and click [Update] to
update the item in the service list.
Delete Click to delete the selected service in the service list
Default Set the eGateway server as the default.
Select an item in the service list, click [Default] and
you can see “Y” in the Default column.
Connect Click to verify whether the connection is normal.

To add an iStorage service

1. Set the iStorage server properties as described above.
2. Tap [Add] to add the service to the service list.
To modify a network service
1. Select the service to be updated in the service list.
2. Modify the parameters in the upper part of the screen and tap [Update] to update the setting.

4.9 Print Preset

This screen is used to set up the printer and image printing.

4.9.1 Print Setting

Item Description
Add Service Click to begin adding print services.
Remove Service Click to delete the selected print service.
Rename Service Click to rename the selected print service.
Property Preset print service properties.

4.9.2 Image Settings

Click [Image Setting] to enter the page, you can set the brightness, contrast and saturation of image
printing, or you can use the default values.

4.10 Maintenance
In the Setup menu, select [Maintenance] to enter the screen.
The [Maintenance] function is designed for you to import or export user data, restore factory setting
and export log. You may also execute self-test and option installation/trial through the maintenance
menu. Furthermore, you can set the factory preset, export the register data, and etc.

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If you require other maintenance functions, please contact Mindray Customer Service Department
or sales representative.

4.10.1 Option
The system enters the Option page after entering the Maintenance screen. In the Option list, the
system lists all the system-supported options and their installation status (not installed or installed).
To install and uninstall:
• Click [Install] to begin installing a disabled option.
• Click [Uninstall] to begin uninstalling a previously-installed option.
Please contact the Mindray Customer Service Department or a sales representative for details.

4.10.2 Exporting Setup Data

This function is used to write all setup data of the system into a disk for backup.
Perform the following procedure:
1. Select the target module.
2. Click [Export] to open the [Export Data] screen.
3. Select the path to save the data.
4. Select the exported file and type as PDP and click [OK].

4.10.3 Importing Setup Data

This function is used to import the existing setup data to the setup data memory of the system. The
system will reset and operate according to the setup preferences that were imported.
Perform the following procedure:
1. Click [Import] to open the Load Data screen.
2. Select the imported file.
3. Click [OK], a progress bar will appear and the setup data is imported to the specified path.
4. To restore the factory setup data, click [Load Factory] on the right side of the screen.

4.10.4 Probe Check

This function is used to check the condition of transducer elements to evaluate the probe
performance.
Before performing the probe check, ensure the probe head must be clean and the probe is in non-
scanning state.
Click [Probe Check] to enter the Probe Check screen:
• If a transducer element is in malfunction, it is displayed as a red spot.
• If a transducer element functions well, it is displayed as a green spot.
You can export the result image to the external device.

4.10.5 Other Settings

Other preset settings are described as follows:

Item Description
Load Factory Local factory default settings.

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Item Description
Setup Export Log Export the log.
Self Test Perform system self-test and restart the machine.
Recover To recover the system.
Enter Windows For password, please contact your service engineer.
Prepay Installment Display the prepay installment information.
Start/Stop WinProxy Cursor debug interface.
Touch Screen To calibrate the touch screen.
Calibration
Needles List Replace Update the list of needles that support eSpacial Navi function.
NOTE:
The list of needles must be release version provided by
Mindray.
Needles List Recover Restore the list of needles that support eSpacial Navi function
to the last version.
Needles List Factory Restore the list of needles that support eSpacial Navi function
to the factory version.
Enable Tracking Enable the transducer and patient tracking function:
• Find transducers used with a patient by patient ID.
• Find patients who used a transducer by transducer SN.
After enabling the tracking function, you can set the maximum
number of days the data can be retained.
Fast Startup To speed up the startup process.
NOTE:
If McAfee has been installed, please disable this function
to avoid McAfee failure.

If you have any questions, please contact the service engineer or your sales representative.

4.11 Security
4.11.1 Drive Encryption/Secure Data Wipe
Encrypt the patient data stored in the hard disk. The system provides two encryption methods:
Factory Default and User Define.
• Factory Default: the system is in factory state by default.
• User Define: add a user-defined password.
Perform the following procedure:
1. Select [User Define].
2. If no patient data are stored in the hard disk, click [Confirm], input the password and click
[Confirm] to finish the password setting
If the patient data are already stored in the hard disk, the system will pop-up prompts, follow
the steps below:

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 4 Setup

a. Click [OK].
b. Click [Wipe] and operate according to the screen prompts to clear patient data.
c. Select [User Define] again, and click [Confirm].
d. Input the password and click [Confirm] to finish the password setting.

NOTE:
• If you want to switch to Factory Default, perform steps above again. The password is the same
as that of the User Define.
• When you set password, multi-language and Chinese characters are not supported.

4.11.2 Anti-Virus
The system provides two anti-virus software: Windows Defender and McAfee. They can
effectively prevent the ultrasound system from being attacked by virus, spyware, or other malware.
• Windows Defender is already installed on the system.
• The McAfee software is an option. If you want to buy McAfee, contact the service engineer or
your sales representative.

NOTE:
McAfee cannot be uninstalled after successful installation.

4.11.3 Transmission Encryption

After accessing the network, click [VPN Config] to enter the “VPN Config” interface, see
“4.8.1 Network Settings”.

4.12 System Information

Click [About] on the Setup menu to enter the system information screen.
This screen displays the system software version and other versions of devices. You cannot edit the
information, only view them. The information varies depending on the system configurations and
version.

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You can start a patient exam in the following situations:

• New patient information: to start a new patient exam, patient information must first be entered.
• New exam: to start a new exam for patient who is already registered, the recorded information
can be obtained through either iStation or Worklist.
• Activate exam: to select an exam that has been completed within 24 hours, continue the exam
with imported patient information and exam data.
• Continue an exam: to select an exam that has been paused within 24 hours, continue the exam
with imported patient information and exam data.

5.1 Patient Information

5.1.1 New Patient Information
CAUTION
Before examining a new patient, tap the [End] on the touch screen to end the
exam of the previous patient, update the patient ID and information, to avoid
mixing data of the next new patient.

To start a new patient exam, it is better to type the detailed patient information. The system will set
up a unique information database for each patient based on the patient information entered, so that
the information of one patient will not be confused with that of another patient.
1. Tap [Info] on the touch screen to enter the patient information page.
Place the cursor onto the targeted box. The field box is highlighted and a flashing cursor
appears. Information can be entered or selected from the options
NOTE:
• Patient ID is generated automatically by the system after starting a new patient, and can
be modified manually.The characters “\”, “*”, “ ” are not permitted.
• You can either enter the patient’s date of birth manually, or click to select the date,
and click [Confirm] to finish.
• The age unit can be “Years”, “Months” or “Days.” If the age is less than one year, the
system will automatically calculate the age in months or days.
2. Exam Type
– Select the exam type tab to enter exam-specific information.
– Input general information/operating Information
3. Functional keys
– [New Patient]: click to clear the current patient information in the patient information
screen in order to input new patient information.

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– [New Exam]: click to clear the current exam information in order to create a new exam for
the current patient.
– [Pause Exam]: to pause the current exam due to some special causes or system power off.
– [Cancel Exam]: to cancel the current exam.
The cancelled exam can’t be restored.
– [Quick Register]: to save the patient information quickly and return to the main screen.
– [OK]: click to save the patient data entered and exit the screen.
– [Cancel]: click to cancel the patient data entered and exit the screen.

5.1.2 Retrieve Patient Information

iStation
The patient data can be obtained in iStation from the system hardware or USB memory device. You
can enter the searching conditions for the patient.
1. Do one of the following to enter iStation screen:
– Tap [iStation] on the touch screen.
– Click [iStation] in the “Patient Info” screen.
– Click [iStation] in the Review screen.

2. Select the data source.

Select the data source in the drop-down list of “Data Source”.
3. Input the searching condition.
The default condition is name. Select a searching condition from the drop-down list, enter a
keyword or select the period in accordance with the condition selected.
Select “Find in results”, the system will search the keyword based on the existed searched
results.
4. Select the desired patient information in the list, and the system pops up the shortcut menu.

Review Image Click to enter the Review screen.

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Patient Infor Click to enter the Patient Info screen.

Review Report Enter diagnostic report screen.
Delete Exam Delete the selected record.
Backup Exam Click to back up the selected patient record to media supported.
Restore Exam Click to import the patient data from an external media.
Send Exam Click to send the selected patient data to external device, storage
server or printer.
Activate Exam Click to continue an exam that has been finished within 24 hours.
Continue Exam Click to continue an exam that has been paused within 24 hours.
Annotation Exam Click to add annotations to the selected exam, or view the history
annotations of the selected exam.

5. Click [New Exam] to enter the Patient Info screen.

The corresponding patient information is also imported to the new exam simultaneously. After
editing the patient information in the Patient Info screen, select [OK] to start a new exam.

WorkList/HL7 Enquiry

TIP:
Worklist is an optional function. Configure DICOM Basic and DICOM WorkList first.

When the DICOM basic package is configured and the Worklist server has been set, click
[Worklist] in the “Patient Info” screen to query or import the patient data. For details, see
“15.3 Worklist”.

5.2 Activate& Continue an Exam

5.2.1 Activate an Exam
In iStation screen, select the exam record finished within 24 hours, and click [Activate Exam] from
the menu popped up; or, click [Active Exam] in iStation or Review screen to activate the exam.

NOTE:
• The system can automatically load the patient information and exam data to continue the
exam.
• If you want to continue an exam which data lies in an external memory database, you have to
first allow the system to load the patient data to the system’s patient database.
• For an only one re-activated exam, you can modify patient ID.

5.2.2 Continue an Exam

In iStation screen, select an exam record paused within 24 hours, click [Resume Exam] from the
menu popped up to continue the exam.
If you want to select a patient data in an external memory database, you have to first allow the
system to load the patient data to the system’s patient database.
The patient ID can be modified for the exam only with one exam record and being activated again.

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5.3 Pause & End an Exam

5.3.1 Pause an Exam
Sometimes, you have to stop an uncompleted exam due to some special causes.When the exam is
paused, the system can begin other exams.
1. Tap [Info] on the touch screen to enter the patient information page.
2. Click [Pause Exam].
If the system is powered off during scanning, the exam status turns “paused” after the system
restart.
When an exam is paused, the system will:
– Save the exam-related images, reports and measurement data, modify the status as
“Paused”.
– Save the exam information, including report, imaging mode, exam mode, image
parameters, operation mode, and imaging/measurement data and so on.

5.3.2 End an Exam

Before examining a new patient, tap [End] to end the exam of the previous patient, update the
patient ID and information, to avoid mixing data of the next new patient.
To end an exam, do one of the following:
• Tap [End] on the touch screen to finish the current exam.
• Click [New Patient] on the Patient Info screen to end the last patient exam and clear the patient
information.
• Click [New Exam] on the Patient Info screen (or iStation screen, or Review screen) to end the
last exam and clear the exam data.

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WARNING
• The images displayed in this system are only reference for diagnosis.
Mindray is not responsible for the correctness of diagnostic results.
• In Dual-B imaging mode, the measurement results of the merged image
may be inaccurate. Therefore, the results are provided for reference only,
not for confirming a diagnosis.

TIP:
Operations for switching between different image modes and optimizing images, see “2.13 Basic
Operations”.

6.1 B Mode
B mode is the basic imaging mode that displays real-time views of anatomical tissues and organs.

6.1.1 B-mode Image Scanning

Press <B> on the control panel to enter B mode.
If the system is in other imaging mode, press <B> to return B mode.
Adjust parameters to optimize the image.

6.1.2 B-mode Image Parameters

Image Quality
Used for switching B/THI and adjusting the frequency. The real-time value of frequency is
displayed in the image parameter area, and if harmonic frequency is used, “F H” is displayed as
harmonic frequency value.
The system provides a THI function using harmonics of echoes to optimize the image. Harmonic
imaging enhances near field resolution and reduces low-frequency and large amplitude noise, so as
to improve small parts imaging.
Please select the frequency according to the detection depth and current tissue features.

Gain
To adjust the gain of the whole receiving information in B mode. The real-time gain value is
displayed in the image parameter area.

Depth
This function is used to adjust the display depth of sampling, the real-time value of which is
displayed in the image parameter area.

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Depth increase will cause a decrease in the frame rate.

TGC
The system compensates the signals from deeper tissue by segments to optimize the image.
There are 8-segment TGC sliders corresponding to the areas in the image.
Adjust the signal gain for the certain image area to get a balanced image.

Quick TGC Adjustment

The system provides “User preset” or “Standard preset” to quickly adjust the TGC sliders.
Touch the desired icon in the “User preset” or “Standard preset” column on the touch screen to
adjust TGC sliders.
Tap the icon on the touch screen to restore TGC to the original status.

TGC User Preset

Users can preset the TGC sliders to the desired position.
Tap the icon on the touch screen to enter TGC user preset screen. Select the desired slider
position in the “Standard preset” or “User Preset” column, make adjustment of the sliders manually
if necessary, and then touch [Save as] to select among Save as User1, Save as User2, and Save as
User3.

Acoustic Power
Refers to the power of ultrasonic wave transmitted by the probe, the real-time value of which is
displayed in the upper left corner of the screen.

TIP:
You should perform exams according to actual situation and follow the ALARA Principle.

Scan range and FOV position

More information can be obtained without moving the probe or changing the sampling position.

TIP:
• The FOV position/range is available only for the convex and phased probes.
• When the scan range is adjusted to the widest, the FOV position cannot be changed.

Steer
To steer the beam the probe transmits.

TIP:
Steer is available only for linear probes.

Line Density
The function determines the quality and information of the image.
The higher the line density is, the higher the resolution becomes.

Dynamic Range
Adjusts contrast resolution of an image, compresses or expands gray display range.
The real-time dynamic range value is displayed on the image parameter area.

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The more the dynamic range, the more specified the information, and the lower the contrast with
more noise.

Smooth
This feature is used to reject the noise and smooth the image.

iClear
The function is used to enhance the image profile so as to distinguish the image boundary for
optimization.

Persistence
Used to superimpose and average adjacent B images, so as to optimize the image and remove
noises.

Rotation/Flip
This function provides a better observation for image display.
The “M” mark indicates the orientation of the image; the M mark is located on the top of the
imaging area by default.

iBeam
This function is used to superimpose and average images of different steer angles to obtain image
optimization.

TIP:
The phased probe does not support iBeam. iBeam is unavailable when ExFov is enabled.

Auto Merge
In the Dual-split mode, when the images of the two windows have the same probe type, depth,
invert status, rotation status and magnification factor, the system will merge the two images so as to
extend the field of vision.

TIP:
Only for linear probes.

Gray Map
Adjusting grayscale contras to optimize the image.

Tint Map
This function provides an imaging process based on color difference rather than gray distinction.

TSI
The TSI function is used to optimize the image by selecting acoustic speed according to tissue
characteristics.

HD Scope
The image inside the ROI is clearer than these outside when the function is enabled.
The function is disabled in frozen state.
The optimize speed is ended when saving the image in real-time.

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iTouch
To optimize image parameters as per the current tissue characteristics for a better image effect.
It is available for all real-time imaging in B mode.

H Scale
Display or hide the width scale (horizontal scale).
The scale of the horizontal scale is the same as that of vertical scale (depth), they change together in
zoom mode, or when the number of the image window changes.The H Scale will be inverted when
image is turned upwards/downwards.

Dual Live
Display different image effects of one probe for a better observation.
Two pages of adjustable parameters are displayed on the touch screen as well; where, shared
parameters and left window parameters are displayed in the B (L) page, while right window
parameters are displayed in the B(R) page.
In the image parameter area, parameters of the both windows are displayed.
It supports the magnification of the image.

LGC
Adjust the gain along the scan line to improve the lateral resolution of the image.

TIP:
The system provides several preset parameters for imaging.

Echo Boost
The contrast is increased and the noise is decreased with the clear boundary after generating the
function.

TIP:
Use phased probe to activate the function in cardiac mode.

6.2 Color Mode

The Color mode is used to detect color flow, and the color is designed to judge the direction and
speed of blood flow.
Generally, the color above the color bar indicates the flow towards the probe, while the color below
the color bar indicates the flow away from the probe; the brighter the color is, the faster the flow
speed becomes; while the darker the color is, the slower the flow speed becomes.

TIP:
In Color Mode, acoustic power is synchronous with that of B Mode. Adjustment of the depth or
zoom to the B Mode image will lead to corresponding changes in Color Mode image.

6.2.1 Color Mode Image Scanning

Perform the following procedure:
1. Select a premium image during B mode scan, and adjust to place the area of interest in the
center of the image.

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2. Press <C> to enter B+Color mode.

3. Use the trackball/trackpad and <Set> to change position and size of the Region of Interest
(ROI).
4. Adjust the image parameters during scan to obtain optimized images.

6.2.2 Color Mode Image Parameters

Color Gain
Refers to the overall sensitivity to flow signals. The real-time gain value is displayed in the image
parameter area.
Increasing the gain will increase the flow signal presented as well as noise, while the signals may be
missing when the gain is adjusted too low.

Image Quality
Refers to the transmitting frequency in Doppler mode of the probe, the real-time value of which is
displayed in the image parameter area.

B/C Align
To set and constrain the maximum width of the B mode image to that of the Color ROI.

Dual Live
This function is used to display B image and Color image synchronously.

Steer
The feature is used to adjust the ROI of color flow with different angles with immobility of the
probe.
This function is used to adjust the scan angle of linear probes, so as to change the angle between the
transmitting beam and flow direction.

TIP:
Steer is available only for linear probes.

Line Density
The function determines the quality and information of the image.
The higher the line density is, the higher the resolution becomes.

Packet Size
This function is an indication of the ability to detect flow, which is used to adjust the accuracy of
color flow.
The higher the sensitivity is, the more sensitive indication for low-velocity flow becomes.

Flow State
Refers to optimizing the various flow states.

Persistence
This function is to adjust the temporal smooth to optimize the image.

Smooth
This feature is used to reject the noise and smooth the image.

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Scale
This function is used to adjust the speed range of color flow, which is adjusted through PRF in the
system. The real-time PRF value is displayed in the image parameter area.
Aliasing may occur if low velocity scale is used and high velocities are encountered.
Low velocities may not be identified when a high velocity scale is used.

Baseline
Refers to the area where the velocity is zero in the scale. Adjust according to the actual situation so
as to get an optimum flow display.

Invert
To set the display mode of the color flow, the color scale will be inverted when the function is
activated.

TIP:
It is available only for linear probes.

Color Map
This function is a combination of several image parameters, which indicates the display effect of
color image.

WF (Wall Filter)
It filters out low-velocity signals to provide effective information, and this function is used to adjust
the filtered frequency. The real-time value (WF) is displayed in the image parameter area.

Smart Track
To optimize image parameters as per the current tissue characteristics for a better image effect. The
angle and the position of the ROI are adjusted after the function is enabled. The area is tracked
without being affected by the dynamic moves.

TIP:
The linear probes for Upper Ext Artery, Upper Ext Vein, Lower Ext Artery, Lower Ext Vein,
carotid, EM Vascular exam supports the smart track.

Priority
This function is used to set levels of the flow display, to display the grayscale signal or color signal.
The color image is preferred with higher value; while grayscale signals are displayed with the lower
value.

Velocity Tag
This function is used to mark the specified velocity range in flow to check the flow function or
specific flow velocity value.
Enable this function, the green mark appears on the color scale. Use trackball/trackpad and <Set> to
set the marking range and marking position.

iTouch
To optimize image parameters as per the current tissue characteristics for a better image effect.

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6.3 Power Mode

Power mode provides a non-directionally display of blood flow in the form of intensity as opposed
to flow velocity.
DirPower (Directional Power Mode) provides the additional information of flow direction towards
or away from the probe.

TIP:
In Power mode, the acoustic power is synchronous with that of B mode. Adjustment of the depth to
the B mode image will lead to corresponding changes in Power mode image.

6.3.1 Power Mode Image Scanning

Perform the following procedure:
1. Select a premium image during B mode or B+ Color scan, and adjust to place the area of
interest in the center of the image.
2. Press <P> to enter B+Power mode.
3. Use the trackball/trackpad and <Set> to change position and size of the Region of Interest
(ROI).
4. Adjust the image parameters during scan to obtain optimized images.

6.3.2 Power Mode Image Parameters

Because both are based on Doppler color imaging, the adjustments of Power mode are same with
these of Color mode’s. Hence, only the adjustments of Power mode are introduced.

Power Gain
Refers to the overall sensitivity to flow signals, and this function is used to adjust the gain in Power
mode. The real-time gain value is displayed in the image parameter area.

Color Map
This feature indicates the display effect of power image. The maps in Power mode image are
grouped into two categories: Power maps and Directional Power maps.
• The Power maps provide information of blood flow, which are highly sensitive to the low-
velocity flows.
• The Directional Power maps provide information of flow direction.

Dynamic Range
This function is to adjust the transformation of echo intensity into color signal.
Increasing dynamic range will lead to higher sensitivity to low-power signals, thus enhances the
range of signals to display.

6.4 M Mode
6.4.1 M Mode Image Scanning
Perform the following procedure:
1. Select a premium image during B mode or B+ Color scan, and adjust to place the area of
interest in the center of the image.

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2. Press <M> on the control panel, and use the trackball/trackpad to adjust the sampling line.
3. Press <M> on the control panel again or <Update> to enter M mode, and then you can observe
the tissue motion along with anatomical images of B mode. During the scanning process, you
can also adjust the sampling line accordingly when necessary.
4. Adjust the image parameters to obtain optimized images.

6.4.2 M Mode Image Parameters

Gain
To adjust the gain of M mode image, the real-time gain value is displayed in the image parameter
area.
Increasing the gain will brighten the image and you can see more received signals. However, noise
may also be increased.

Display Format
To set the display format of B mode image and M mode image.
Adjust according to the actual situation and obtain a desired analysis through comparison.

Speed
This function is used to set the scan speed of M mode imaging, and the real-time speed value is
displayed in the image parameter area.

Tint Map
This function provides an imaging process based on color difference rather than gray distinction.

Gray Map
Adjusting grayscale contrast to optimize the image.

Edge Enhance
This function is used to increase image profile, so as to distinguish the image boundary.
Larger edge enhance may lead to noise increase.

Dynamic Range
Adjusts contrast resolution of an image, compresses or expands gray display range. The real-time
dynamic range value will be displayed on the image parameter area on the top of the screen.

M Soften
This feature is used to process the scan lines of M images to reject noise, making the image details
to be clearer.

6.5 Color M Mode (CM)

To know the cardiac motion state, CM is overlaid with flow based on M mode, which is more
sensitive to the instantaneous signal changes. Then, it shows the diagnosis information in detail.

TIP:
Linear probe does not support Color M mode.

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6.5.1 CM Image Scanning

Perform the following procedure:
1. To enter CM mode:
– In B+M mode, press <C>.
– In B+Color, press <M>.
2. Adjust the image parameters to obtain optimized images.

6.5.2 CM Image Parameters

In CM mode, parameters that can be adjusted are in accordance with those in B, M and Color
modes; please refer to relevant sections of B, Color and M mode for details.
The ROI size and position determine the size and position of the color flow displayed in the color
M mode image.

6.6 Anatomical M Mode

For an image in the traditional M mode, the M-mark line goes along the beams transmitted from the
probe. Thus it is difficult to obtain a good plane for difficult-to-image patients who cannot be
moved easily. However, in the Anatomical M mode, you can manipulate the M-mark line and move
it to any position at desired angles. The system supports anatomical M scanning (including Free
Xros M mode and Free Xros CM mode) in 2D imaging modes (B, Color, Power and TVI mode).

CAUTION
Anatomical M Mode and Color Anatomical M mode images are provided for
reference only, not for confirming diagnoses. Compare the image with those of
other machines, or make diagnoses using non-ultrasound methods.

TIP:
Free Xros M imaging and Free Xros CM imaging are options.

6.6.1 Linear Anatomical M (Free Xros M)

Free Xros M imaging is supported on frozen B image, B+M image and B+Power/Color/TVI image.
Perform the following procedure:
1. Adjust the probe and image to obtain the desired plane in real-time B mode or M mode.
Or select the B mode cine file to be observed.
2. Tap [Free Xros M] on the touch screen to enter Free Xros M mode or press the user-defined
key to enter Free Xros M mode.
There are 3 M-mark lines available, each with a symbol of “A”, “B” or “C” at one end as
identification.
3. Adjust the sampling line (single line or couple of lines) to obtain optimized images and
necessary information.
– Tap [Show A], [Show B] or [Show C] on the touch screen to adjust the sampling line. The
corresponding sampling line and the Free Xros M image appear on the screen. Then,
activate the sampling line.

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– Tap [Display Cur.] or [Display All] on the touch screen to select whether to display the
image of the current M-mark line or all.
You can choose to display the sampling line on the current image or all.
– Press <Set> to switch among the sampling lines and press <Cursor> to show the cursor.
4. Adjust the image parameters to obtain optimized images.
5. Press <B> to return to real-time B mode.

6.6.2 Free Xros CM (Curved Anatomical M-Mode)

In Free Xros CM mode, the distance/time curve is generated from the sample line manually
depicted anywhere on the image. Free Xros CM is used for TVI and TEI modes.

CAUTION
Curved anatomical M image in the operator’s manual that it is provided for
reference, not for confirming a diagnosis. Generally it should be compared with
other device or make a diagnosis by non-ultrasonic methods.

TIP:
Only phased probe supports Free Xros CM.

Perform the following procedure:

1. In real-time 2D mode, adjust the probe and image to obtain the desired plane.
2. Press <TDI> to obtain the image.
3. Tap [Free Xros CM] on the touch screen to enter the mode.
4. Use the trackball/trackpad to define the start point of the sampling line on the 2D image.
The cursor displays as +, and can be moved within the 2D image only.
5. Press <Set> to fix the start point, and the digital number “1” is marked beside the point.
6. Define the next point using the trackball/trackpad and <Set> key (tap [Undo] on the touch
screen to cancel the current point and activate the preview point). The system updates the time-
motion curve in real time, and each point is marked with a number in sequence.
7. Repeat Step 6 to finish the sampling line.
8. Double press <Set> to finish the editing.
9. You can edit the curve if needed:
a. After finishing the sampling line, tap [Edit] on the touch screen. The cursor becomes the
icon .
b. Move the cursor over the curve, press <Set> to activate the spot.
c. Move the cursor to change the shape of the curve.
d. Double press <Set> to finish the editing.
NOTE:
Tap [Delete] on the touch screen to remove the curve, and tap [Edit] to re-edit the curve.
10. Adjust the parameters to obtain the desired tissue of Free Xros CM image. Then, save the
image.
11. Tap [Free Xros CM] or press the user-defined key for “Free Xros CM”, or press <B> to exit.

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6.6.3 Anatomical M Mode Parameters

In anatomical M mode, adjustable parameters are similar with these in M mode.

6.7 PW/CW Mode

PW (Pulsed Wave Doppler) mode or CW (Continuous Wave Doppler) mode is used to provide
blood flow velocity and direction utilizing a real-time spectral display. The horizontal axis
represents time, while the vertical axis represents Doppler frequency shift.
PW mode provides a function to examine flow at one specific site for its velocity, direction and
features; while CW mode proves to be much more sensitive to high velocity flow display. Thus, a
combination of both modes will contribute to a much more accurate analysis.
CW module is optional.

6.7.1 PW/CW Mode Image Scanning

Perform the following procedure:
1. Select a premium image during B mode or B+ Color (Power) scan, and adjust to place the area
of interest in the center of the image.
2. Press <PW>/<CW> or the user-defined key to adjust the sampling line.
The sampling status will be displayed in the image parameter area.
3. Set the position of the sample line and the SVD by using the trackball/trackpad, and adjust the
angle and SV size according to the actual situation.
4. Press <PW>/<CW> or the user-defined key again or <Update> to enter PW/CW mode and
perform the examination.
Observe and calculate the data based on B mode or Color mode image. You can also adjust the
SV size, angle and depth in the real-time scan.
5. Adjust the image parameters to obtain optimized images.

6.7.2 PW/CW Mode Image Parameters

Gain
This function is intended to adjust the gain of spectrum map. The real-time gain value is displayed
in the image parameter area.

PW Sampling Gate
Adjusts the SV position and size of sampling in PW mode, the real-time value of SV and SVD are
displayed in the image parameter area, in which SV represents the size of the sampling gate, and
SVD represents the sampling depth.

CW Focus Position
To adjust the focus position of CW mode. The real-time focus position value is displayed on the
image parameter area in SVD.

Image Quality
Refers to the transmitting frequency in Doppler mode of the probe, the real-time value of which is
displayed in the image parameter area.

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Scale
This function is used to adjust the speed range of color flow, which is adjusted through PRF in the
system. The real-time PRF value is displayed in the image parameter area.
To provide a much clearer color flow image.
Use low PRF to observe low-velocity flows, and use high PRF to observe high-velocity flows.

iTouch
To optimize image parameters as per the current tissue characteristics for a better image effect.

Auto Calculation
This function is used to trace the spectrum and calculate the PW/CW mode image parameters. The
results are displayed in the results window.
In real-time scanning, the results displayed are derived from the calculation of the latest cardiac
cycle.
In the freeze and cine status, the results displayed are calculated from the current selected area.
• Auto Calculation Parameter: To set the calculation results to display.
• Auto Calculation Cycle: To set the heart cycle number for auto-calculation.
• Trace Area: To set the trace area of the Doppler wave in the spectrum map, applicable for auto
calculation, V Max and V Mean display.
• Trace Smooth: To set the smooth level when tracing.
• Trace Sensitivity: This function is used to set the sensitivity of tracing in the spectrum.

Invert
This function is used to set the display manner of spectrum.

TIP:
It is available only for linear probes.

Speed
This function is used to set the scan speed of PW mode imaging.

T/F Res
Adjusts for a balance between time resolution and spatial resolution.

WF (Wall Filter)
To display the image accurately, it adjusts the cut-off used in the wall filter, and filters out the flow
noise which is produced by vessel wall vibration. The real-time value is displayed in the image
parameter area.

Tint Map
This function provides an imaging process based on color difference rather than gray distinction.

Gray Map
Selects among post processing map curves to optimize grayscale images.

Display Format
Sets the display proportion of PW mode image and B mode image.

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Duplex/Triplex
This function is used to set if B image or B+Color image (Power) is scanned synchronously.

HPRF
HPRF mode is used when detected velocities exceed the processing capabilities of the currently
selected PW Doppler scale or when the selected anatomical site is too deep for the selective PW
Doppler scale.

Baseline
Refers to the area where the velocity in zero in the spectrum. The map changes after being edited.

Angle
This function is used to adjust the angle between Doppler vector and flow to make the velocity
more accurate.
The real-time adjusting angle value is displayed in the image parameter area.

Quick Angle
Adjusts the angle faster in increments of 60°, and the real-time value of which is displayed in the
image parameter area.

Dynamic Range
The dynamic range conveys the information that being transformed from echo intensity to gray
scale.

Audio
Adjusts the output audio in spectrum Doppler.

Steer
Adjusts the scan angle in PW mode, so as to change the angle between the transmitting beam and
flow direction.
Obtain more information with immobility of the probe.
Values of steer angles vary with the probe.

TIP:
Steer is available only for linear probes.

6.8 TDI
TDI mode is intended to provide information of low-velocity and high-amplitude tissue motion,
specifically for cardiac movement.
There are 4 types of TDI mode available:
• Tissue Velocity Imaging (TVI): This imaging mode is used to detect tissue movement with
direction and speed information. Generally the warm color indicates the movement towards
the transducer, while the cool color indicates the movement away from the transducer.
• Tissue Energy Imaging (TEI): This imaging mode reflects the status of cardiac movement by
providing the energy information, the larger the energy is, the brighter the color becomes.
• Tissue Velocity Doppler Mode (TVD): This imaging mode provides direction and speed
information of the tissue.

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• Tissue Velocity M Mode (TVM): This function assists to observe the cardiac motion through a
direct angle.

TIP:
TDI is optional.

6.8.1 TDI Mode Image Scanning

Perform the following procedure:
1. Press <TDI> or the user-defined key to enter the TDI mode.
– In B or B+Color mode: to enter TVI Mode, parameters of TVI mode will be displayed on
the touch screen.
– In Power mode: to enter TEI Mode, parameters of TEI mode will be displayed on the
touch screen.
– PW mode: Press <TDI> or the user-defined key and then press <PW> or <Update> to
enter TVD. The parameters of TCD are displayed on the touch screen.
– M mode: Press <TDI> or the user-defined key and then press <M> or <Update> to enter
TVM. The parameters of TVM are displayed on the touch screen.
2. Adjust the image parameters to obtain optimized images.
3. Press <TDI> or the user-defined key to exit from TDI mode and enter general imaging modes.
Or, press <B> on the control panel to return to B mode.

6.8.2 TDI Mode Image Parameters

In each TDI mode, the parameters that can be adjusted are similar to those in the color flow modes
(Color, PW, and Power). See the relevant sections for details. The following introduces the specific
items in TDI mode.

Tissue State
This function is used for fast image optimization.

6.8.3 TDI Quantitative Analysis

CAUTION
TDI is provided for reference, not for confirming a diagnosis.

NOTE:
To perform the strain and strain curve, the ECG curve is in need in case of the deviation in curve.

TIP:
• TDI quantitative analysis is an option.
• The current image (in frozen state) and the saved image can be used in the quantitative
analysis.
• Only after the user chooses the image review, the quantitative analysis is available.If the user
chooses the static image (only one frame), the quantitative analysis is not available.

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It is about analyzing the data of TVI imaging and measuring the velocity of the myocardium with
the cardiac cycle.
Here are three types of curves to perform the quantitative analysis:
• Velocity-time curve
• Strain-time curve
• Strain rate-time curve
– Strain: Deformation and displacement of the tissue within the specified time.
– Strain rate: speed of the deformation, as myocardial variability will result in velocity
gradient, strain rate is used commonly to evaluate how fast the tissue is deforming.

Figure 6-1 Quantitative analysis display (taking velocity-time curve as the example)

1 TDI review Sampling area: indicates the sampling position of the curve. The
sampling lines are marked with color numbers. It can mark 8
ROIs at most.
2 2D grey image review • Use the trackball/trackpad; the images in TDI review
window and 2D review window are reviewed synchronously,
since the two images are frozen at the same time.
• ROI movement is linked between the TDI (Tissue Doppler
Imaging) review window and the 2D imaging reviewing
window.

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3 Display analysis curve • Y-axis represents the velocity (unit: cm/s) [in strain-time
curve, Y-axis represents the strain (%); in strain-time curve,
Y-axis represents the strain (unit: 1/s)].
• X-axis represents time (s);
• Frame mark: a white straight line perpendicular to the X-
axis, and can be moved left and right by using the trackball/
trackpad.
• Click the check box in front of the ROI to display or hide the
analysis curve.
• You can get the current X/Y axis value by moving the cursor
onto one point on the curve; and if you press <Set> at this
time, the frame marker will move to the spot.
4 ECG display area /

Perform the following procedure:

1. Scan the image with the moves of myocardium on, freeze the image and select the scan scope,
or open the image which includes the myocardium moves already.
NOTE:
• The current image (in frozen state) and the saved image can be used in the quantitative
analysis.
• Only after the user chooses the image review, the quantitative analysis is available. If
the user chooses the static image (only one frame), the quantitative analysis is not
available.
2. Tap [TDI QA] or press the user-defined key for “TDI QA” to enable the function.
3. Mark the interested myocardium area.
One image can save 8 ROIs at most, and draw the corresponding curve in image area. Each
ROI has different color; the corresponding curve is painted with each color.
ROI settings:
a. Tap [Standard ROI]/[Ellipse ROI] to select a ROI method.
The cursor moves into the review area (TDI review window or 2D grey review window.
b. Review to the desired frame.
c. Move the cursor to one cine review window.
d. Add a ROI.
When selecting “Standard ROI”: Add ROI automatically after capturing the area. ROI
size is decided by “Standard Height/Width/Angle”.
When selecting “Ellipse ROI”: Press <Set> to confirm the start point, and use the
trackball/trackpad and press <Set> to confirm the next point; then use the trackball/
trackpad to adjust the size and press <Set> to complete the drawing.
You can press <Clear> to remove the last ROI.
4. Select the curve: Tap [Speed], [Strain] or [Strain Rate].
For [Strain] or [Strain Rate], tap [Strain Dist.] on the touch screen to select the corresponding
value for Strain – Time curve or Strain Rate – Time curve.
If needed, tap [ROI Tracking] to enable the function. This function provides a motion
compensated ROI as precise time-intensity information can be acquired using active tracking.
It can enhance the calculation accuracy as reducing the impact of probe or patient respiratory
movement.

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NOTE:
Elliptical ROIs can be positioned in any manner that keeps their center within the image
boundaries. In the case that part of the ROI is outside the image boundary, only data from
within the image boundary is used for calculating the mean intensity value.
5. Adjust the curve display:
– X Scale: Choose different value, so that the X scale display manner will be changed. This
function can be used to track detailed tissue information.
– Smooth: Adjust the smooth feature of the curves.
6. Save the curves, and export the curve data, parameter data.
a. Tap [Export] on the touch screen.
The dialog box appears.
b. Select the storage path and type the file name.
E drive is default; and the file type is .CSV.
c. Click [OK] to complete the export.
After being exported successfully, a BMP. file shows on the thumbnail area.
The exported data include:
– Current image;
– Analysis curve data;
– Analysis parameter.
7. Tap [Exit] to exit the quantitative analysis.

6.9 iScape
The iScape panoramic imaging feature extends your field of view by piecing together multiple B
images into a single, extended B image. Use this feature, for example, to view a complete hand or
thyroid.
When scanning, move the probe linearly and acquire a series of B images. The system pieces these
images together into a single, extended B image in real time. The system also supports out-and-
back image piecing.
After obtaining the extended image, you can rotate it, move it linearly, magnify it, add comments or
body marks, or perform measurements on the extended image.
The system provides a color iScape function, so you can get more information from extended
images.

CAUTION
• It is provided for reference, not for confirming a diagnosis.
• iScape panoramic imaging constructs an extended image from individual
image frames. The quality of the resulting image is user-dependent and
requires operator skill and additional practice to become fully proficient.
Therefore, the measurement results can be inaccurate. Exercise caution
when you perform measurements in iScape mode. A smooth and even
speed will help produce optimal image results.

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NOTE:
• Guidance and precautions for even movement:
– Make sure there is enough coupling gel along the scan path.
– Always move the probe slowly and steadily.
– Continuous contact is required throughout the length of the extended image. Do not lift
the probe from the skin's surface.
– Always keep the probe perpendicular to the skin's surface. Do not rock, rotate or tilt the
probe during the scan.
– The system accommodates a reasonable range of motion velocity. Do not make abrupt
changes in motion speed.
• Deeper scans generally require reduced acquisition speed.

NOTE:
• iScape is an option.
• Needle mark cannot be displayed in iScape imaging mode.

6.9.1 Basic Procedures for iScape Imaging

Perform the following procedure:
1. Connect an appropriate iScape compatible probe. Make sure there is enough coupling gel
along the scan path.
2. Press the user-defined key for “iScape View” or tap [iScape View] on the touch screen (it is
available after enter Power/Color mode).
3. Optimize the 2D mode image:
In the capture preparation status, tap [B] ([Power]/[Color]) page tab to go for the B mode
image optimization. Do measurement or add comment/bodymark to the image if needed.
4. Tap [iScape View] page tab to enter the iScape acquisition preparation status.
5. Tap [Start Capture] or press <Update> on the control panel to begin the capture.
The system enters into image review status when the acquisition is completed. You can
perform operations such as parameter adjusting.
6. Scan slowly to obtain a single extended field of view image. You can also erase and retrace if
the image is not satisfactory.
– During image acquisition, none of the parameters are adjustable, and functions such as
measurement, comments and body marks are not available.
– A green box on the image indicating the boundary between the merged images and the
unfinished images.
– During image slicing, the system gives feedback on the probe’s moving speed in the form
of colors and words. The meanings are as follows:

Status ROI Color Tip

Speed too low Blue Moving speed of the probe is too low.
Appropriate Green /
Speed too high Red Moving speed of the probe is too high.

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7. Do one of following to end image capture:

– Tap [Stop Capture] on the touch screen.
– Press <Update>.
– Wait until the acquisition completes automatically.
After the acquisition is completed, the panoramic image will be displayed and the system
enters iScape viewing mode.

6.9.2 Image Review

After the acquisition is completed, the panoramic image will be displayed and the system enters
iScape viewing mode.

6.9.3 Evaluate image quality

Many variables may affect the overall image quality. It is important to evaluate the image content
and quality before an image is used for diagnosis or measurements.

NOTE:
• iScape panoramic imaging is intended for use by well-trained ultrasound operators or
physicians. The operator must recognize image items that will produce a sub-optimal or
unreliable image.
• If the image quality cannot satisfy the following criteria, you shall remove the image and
capture it again.
– The Image must be continuous (no part of an image moves suddenly or disappears.)
– No shadow or absent signal along the scan plane.
– Clear profile of anatomy through the entire scan plane without distortion.
– Skin line is continuous.
– The images are captured from the same plane.
– There are no large black areas in the image.

6.9.4 Cine Review

Tap [Review Cine] on the touch screen in panoramic image viewing status to enter cine reviewing
mode. In cine reviewing mode, a frame marker indicates the sequence of the currently reviewed
images in the panoramic image on the left-hand side of screen.
In cine review status:
• Use the trackball/trackpad to review the captured images frame by frame.
• Tap [Auto Play] to start or end auto play.
• In auto play mode, tap [Auto Play] on the touch screen, or press/rotate the corresponding knob
to change the play speed. When the speed is off, the system exits auto play mode.
• Review to a certain image. Tap [Set Begin] to set the start point. Review to another image. Tap
[Set End] to set the end point. In auto play mode, the review region is confined to the set start
point and end point.
• Tap [iScape View] > [Overview] on the touch screen to exit cine review mode. The panoramic
image displays.
• In cine review mode, press <Freeze> on the control panel to return to the acquisition
preparation status.

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6.10 R-VQS
R-VQS (RF-data based quantification on arterial stiffness) tracks movements of the upper and
lower vessel walls and measures vessel diameter, displacement, coefficient of hardness and PWV
(dimensionless pulse wave velocity).
Hardness coefficient: Arterial stiffness is changed with the blood pressure changing. The bigger the
value the higher the stiffness.
PWV (dimensionless pulse wave velocity) represents the transmit speed of pulse wave. The bigger
the stiffness parameter the higher the PWV.

NOTE:
• Vascular Package should be configured.
• R-VQS is an option.
• Only linear probe under Carotid exam mode supports this feature.

Perform the following procedure:

1. Select a probe and carotid exam mode. Perform B real-time imaging and search for carotid
vessel. Try to place the vessel on the image horizontally.
2. Tap [R-VQS] and use the trackball/trackpad to locate the ROI box on the target area.
Dotted line of the ROI lies in the middle of the vessel and divides the vessel upper wall and
lower wall. Use <Set> key and trackball/trackpad to change ROI size and position.
Note that ROI should include the upper and lower wall of the vessel.
3. Tap [Start Calc] to start tracking. Upper wall and lower wall are marked by the line in the ROI
box.
Motion curve of vessel walls display under the image in real time. 6 cardiac cycles are
calculated in total with each results display in the result window on the left synchronously.
Where,
Dist = [maximum diameter within 1 s] – [minimum diameter within 1 s]
Diam: Vessel diameter refers to maximum diameter within 1 s.
6 R-VQS (RF-data based quantification on arterial stiffness) values (6 cardiac cycles are
calculated in total), standard deviation SD and ROI length will be displayed in the result
window on the left.

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4. Adjust parameters.
– Speed: Adjust refresh speed of vessel wall motion curve.
– Position: Adjust the location of the motion curve upwards and downwards.
– Curve Disp (Min)/Curve Disp (Max): Adjust amplitude of vessel wall motion curve.
5. Tap [Stop Calc] or press <Freeze> to freeze the image and stop updating motion curve and
result data.
6. Use the trackball/trackpad to review the cine file and select desired frame.
– Tap [Accept Result] to update the result window data to the report.
Save the single-frame and multi-frame image if necessary.
– Tap [Cancel Result] to recalculate and perform step 3-5 if necessary.
7. Tap [Report] to check report.
Only the last result data will be saved.
If pressure is entered in the patient information page or the report page, Hardness coefficient
and PWV result will be displayed on the report.
For details about report operation, refer to Advanced Volume.

6.11 Smart B-line

The lung acoustic impedance difference increases with the increase of lung liquids. The ultrasound
waves produce strong reverberations in the lung at different depth. After multiple reflections, the
comet tail sign is formed, which is perpendicular to the pleura plane. Starting from the pleura line,
the comet tail sign moves along with the lung and extends to the far field. The reverberation line
perpendicular to the pleura plane is called Smart B-line.
Smart B-line is used to detect the B line of the lung in B mode. It supports B-line detecting in both
real-time and freeze modes.

TIP:
• Smart B-line is only available in Single B imaging mode.
• It supports single-frame and multi-frame image file detection in B mode.

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• Smart B-line is an option.

6.11.1 Basic Procedures for Smart B-line

Perform the following procedure:
1. Select an appropriate probe and exam mode. The system enters the B mode by default.
2. Adjust the image parameters to obtain optimized images.
For details about image parameter adjustment, see “6.1 B Mode”.
3. Tap [Smart B-line] on the touch screen or the user-defined key to enter Smart B-line mode.
Tap [Scanning Areas] to select different zone combinations for examination.
4. Select a desired zone, and tap [Auto Calc].
The system automatically starts tracing the B line sampling area, and automatically recognizes
and traces the B line in frame.
If necessary, use the trackball/trackpad and <Set> keys to adjust the B line sampling area.
5. Press the <Freeze> key to freeze the image.
The system automatically calculates the quantitative index, and the calculation results are
displayed on the screen.

– B Lines: indicates the number of B lines of the current frame. The number can be 1, 2, 3,
4, or ≥5. When the number is equal to or greater than 5, the system does not display a
specific number.
– Percent: indicates the percent of the B lines area against the total sampling area.
– Score: the score is among 0 to 3.
Normal: when there are a lung sliding sign and A line, or isolated B lines (<3), it is
marked as N in the brackets and the score is 0.
Moderate: when there are multiple clearly-distributed B lines, it is marked as B1 in the
brackets and the score is 1.
Severe: when there are intensively fused B lines, it is marked as B2 in the brackets and the
score is 2.
Lung consolidation: when the lung has a symptom that is similar to the liver lesion
structure and air bronchogram, it is marked as C in the brackets and the score is 3. When

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the lung consolidation and pleural effusion occur at the same time, it is marked as C/P in
the brackets and the score is 3.
– Dist n (B Line distance): indicates the distance between the 2 neighboring lines and is
measured in the pleura line area, among which, n corresponds to the number between the
2 B lines.
– Avg Dist (B Line average distance): indicates the average distance of all B lines.
According to the quantitative index calculated by the system, you can add image and diagnosis
information. Tap the check box under the [Image] or [Diagnosis] tab to select items:

6. Press the <Save> key to save the single-frame image and B line calculation results.
If necessary, press the <Freeze> key again to unfreeze the image. Repeat steps 4-6 to finish
calculating other points.
7. Tap [Report], and select “Fluid Management” from the drop list box of [Report Type] to check
report.
For details about report operation, refer to Advanced Volume.

6.11.2 Overview
After capturing images, tap [Overview] to enter the Overview screen. The Smart B-line supports
displaying two types of lung overviews in the main screen. You can switch the two lung overviews
using the corresponding buttons on the touch screen.
• Image Map: Displays the ultrasound images of all zones, so as to check the overall lung
condition. Ever lung zone displays the ultrasound image with the highest percent of the B line
area by default.
If a zone saves multiple ultrasound images, tap the point corresponds to this zone, and tap [Pre
Item] and [Next Item] to switch the image.
• Color Map: Displays the color map of the lung and ultrasound image of a zone. The color map
uses different colors to mark the ultrasound image analysis result of every lung zone. This
analysis result is calculated from the ultrasound image with the highest percent of B line area.
Tap a point on the touch screen to check the calculation result of the zone related to this point.

6.12 Smart VTI

Smart VTI (Velocity-Time Integral) is used to calculate the CO (cardiac output) of the LVOT (left
ventricular output tract), so as to quickly evaluate the cardiac function.

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TIP:
• The cardiac package should be configured in advance.
• Smart VTI is an option.
• Smart VTI supports B mode image calculation in real time.

Perform the following procedure:

1. Select a phased probe and “Adult Cardiac” exam mode.
2. Move the probe to capture an appropriate image of the long axis view of the left ventricular
near the sternum.
3. Press the <Measure> key to enter the application measurement. Select the “LVOT Diam” item
and the measurement cursor is displayed on the main screen.
a. Move the cursor to the starting point and press <Set> to confirm.
b. Move the cursor to the end point.
Press <Clear> to cancel setting the starting point for measurement and <Update> to
switch the active end and fixed end of the caliper.
c. Press <Set> to set the end point.
For more information about measurement, see Advanced Volume.
4. Press the <Freeze> key to unfreeze the image. Move the probe to capture an appropriate image
of the apical five chamber view.
5. Tap [Smart VTI] on the touch screen or the user-defined key to enter the Smart VTI mode.
The system will:
– Automatically trace the color VOI, and PW sampling line and sampling volume.
– Automatically recognize the cardiac cycle: when there are ECG inputs, the ECG signals
are preferred; when there are no ECG signals, the system automatically starts calculation.
– Trace the LVOT spectrum in a cardiac cycle in real time to gain the VTI, HR, and CO
results of the LVOT.
6. If necessary, adjust the color VOI, and PW sampling line and sampling volume:
– Use the trackball/trackpad and <Set> keys to adjust the color VOI position and size, and
the PW sampling line position.
– Tap the PW tab to enter the PW mode, and adjust the PW sampling volume.
After adjustment, the LVOT spectrum tracing and calculation results display in real time.
7. Press the <Freeze> key to freeze the image, and check the Smart VTI calculation results.
If necessary, you can edit the LOVT spectrum manually:
a. Tap [Edit VTI] on the touch screen.
b. Press the <Cursor> key to activate the cursor.
c. Move the cursor to the spectrum tracing line and press the <Set> key.
d. Use the trackball/trackpad to trace a line.
After tracing, the calculation results display in real time.
8. Tap [Save VTI] to save the Smart VTI calculation results of the current cardiac cycle to the
report.
9. Tap [Graph] to check the quantitative index trend curve.
VTI, SV, and CO have different trend curves and are differentiated by colors. A maximum of 6
sets of Smart VTI results can be saved and displayed.

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10. Tap [Report], and select “Fluid Management” from the drop list box of [Report Type] to check
report.
For details about report operation, refer to Advanced Volume.

6.13 Smart IVC

Smart IVC is used to automatically measure the IVC inner diameter and calculate the change rate in
the B mode image. Measure the IVC (Inferior Vena Cava) in real time, and the system
automatically tracks and measures the changes of IVC inner diameter. It can be used to assist in
treatments, such as volume estimation and fluid infusion.

TIP:
• Smart IVC is an option.
• Smart IVC supports calculation in both real time and freeze modes.
– Enable Smart IVC in real time. The calculation starts from the current frame and ends
after the image is frozen.
– Enable Smart IVC in freeze mode or from the cine file. The calculation starts from the
current frame and ends at the last frame. If the cine length is no longer than 10 seconds, it
is allowed to calculate in retrospective from the current frame after the cine length reaches
10 seconds.

Perform the following procedure:

1. Select an appropriate probe and exam mode.
2. Move the probe to gain an appropriate IVC long axis image.
3. Tap [Smart IVC] on the touch screen or the user-defined key to enter Smart IVC mode and
start calculation.
a. Tap to select a breath type: Spontaneous Breath or Mechanical Ventilation.
b. Select [Change Resp time] > [Resp Time] to set a respiratory time.
The system measures the IVC inner diameter of the image in every frame, calculates the
maximum and minimum IVC diameters, and draws a quantitative index change curve in real
time.
4. If necessary, you can adjust the IVC sampling line manually:
a. Tap [Edit Line] on the touch screen.

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b. Use [Angle] on the touch screen to adjust the sampling line angle, and use the trackball/
trackpad to adjust the sampling line position.
c. Press the <Update> key to start calculating IVC again.
5. Press the <Freeze> key to freeze the image and finish calculating IVC.
The calculation results and quantitative trend curve are displayed on the main screen. Tap the
diagnostic Information item on the touch screen to add diagnostic information to the image
quickly.

6
1

2
Volume
responsiveness 5

1 B Mode Image /
2 IVC CI Corresponds to the selected breath type:
(Collapsibility • Spontaneous Breath: displays the IVC CI curve.
Index), DI • Mechanical Vent: displays the IVC DI curve and IVCV curve.
(Distensibility
Index), IVCV trend
curve
3 IVC Sampling Line /
4 IVC Trending Line The horizontal axis represents the time, which is displayed in the
below Free Xros M image, and is traced along the IVC vessel wall.
5 Diagnostic Displays the added diagnostic information.
Information
6 Calculation Results Displays the calculation results within the current calculation range.
Window • Dmax: indicates the maximum IVC inner diameter within a
respiratory cycle.
• Dmin: indicates the minimum IVC inner diameter within a
respiratory cycle.
• IVC CI = (Dmax-Dmin)/Dmax
• IVC DI = (Dmax-Dmin)/Dmin
• IVCV = (Dmax-Dmin)/[(Dmax+Dmin)/2]

6. Tap [Save Data] to save the calculating IVC results to the report.
7. Tap [Report], and select “Fluid Management” from the drop list box of [Report Type] to check
report.
For details about report operation, refer to Advanced Volume.

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6.14 RIMT (Real-time Intima-Media Thickness)

RIMT early detects and prevents coronary heart disease, artery vessel from being pathological, and
estimates the therapeutic effects. RIMT detects the changes of the vascular intima in real time, and
monitors and calculates the thickness of the carotid intima automatically.

TIP:
• RIMT is an option.
• It is merely available to enter RIMT imaging mode in B single window and dual window when
adopting linear probe for carotid exam.
• Do not press the probe after entering RIMT imaging mode when scanning the image in real
time.

Perform the following procedure:

1. Select the probe first. Perform B mode in carotid exam mode. Detect the patient’s carotid in B
mode. Keep the acoustic beam vertical with the anterior and the posterior of the vascular and
make the anterior and the posterior of the intima visible at the carotid stenosis to obtain a
premium image.
2. Tap [RIMT] to activate the function. Use [Side] on the touch screen to select left or right
carotid.
3. Use the trackball/trackpad to locate ROI over the target area. The dotted line of the ROI is in
the middle of the blood vessel. Press <Set> to confirm the position and size of the ROI.
4. Tap [Start Calc] to measure RIMT of left carotid and right carotid. 6 RIMT values (each RIMT
value represents maximum IMT value within one cardiac cycle), RIMT average value
(arithmetic mean value of the 6 RIMT values), SD (standard deviation of the 6 RIMT values)
and ROI length are displayed in the result pane.
– Tap [Accept Result] or press <Set>, the image is frozen. You may save single frame image
and results to the result pane.
– Tap [Cancel Result] to recalculate RIMT. Perform step 4 to reset the RIMT.
5. Tap [Report] to view the report. Only last acceptable data, including RIMT on left and right
carotid, is in the data sheet.
You can perform:
– Deleting data: select RIMT data from the data sheet. Tap [Delete Rows] to remove the
RIMT data of the left and the right carotid.
– Viewing graphic: tap [IMT Trend] to view the RIMT graphic. The data on the graphic is
same with these in data list. The RIMT average value, SD and ROI length of the exams
are displayed at the bottom of the graphic (including the current exam).
– Previewing the report: tap [Preview] to show IMT. The RIMT average value, SD and ROI
length of the exams are displayed.
For details about report operation, refer to Advanced Volume.
6. Tap [RIMT] again to exit.

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6.15 Tissue Tracking Quantitative Analysis

CAUTION
Tissue Tracking Quantitative Analysis images are provided for reference only,
not for confirming diagnoses.

Apart from TDI imaging function, the system also provides tissue tracking QA function for
myocardial movement evaluation.
By tissue tracking QA function, the ultrasound system will scan each pixel position by frame within
the cardiac cycle, and then use region matching method and auto-correlation searching method to
trace each spot and calculate the movement, so as to determine myocardial motion in a more
quantitative way.
Tissue tracking quantitative analysis is an option.

NOTE:
Only use the probes that support stress echo function under the cardiac mode to start Tissue
Tracking QA function.

6.15.1 Basic Procedures for Tissue Tracking QA

Perform the following procedure:
1. Open a saved B mode cardiac cine file.
A cin. format file which contains more than 1 cardiac cycle (with 2 R waves) and ECG signal.
2. Tap [Tissue Tracking QA] or press the user-defined key to activate the function:
– You can determine the image of interest by previewing the image.
– Use [Cycle] to select and find the image of interest.
3. Select the corresponding section name and locate one frame image with good image effect by
cine play. Use the cursor to set the reference point:
– Long axis section: use the “3-point” method or “Manual” method to set.
– Short axis section: enter multiple points (at least 6 points) using the cursor manually to
set.
4. After reference points are set, the system will display the boundary of the endocardium and
epicardium. Adjust the thickness if necessary.
If the traced result is poor, tap [Reload] to re-trace the reference points, or make fine
adjustments to the points using the cursor.
If the cycles are not adequate to provide the information, switch to another cycle to trace.
5. Tap [Start Tracking] on the soft menu to start the tracking function. Adjust the parameters if
necessary.
Tap [Edit] on the soft menu to display the cursor. Use the trackball/trackpad and press <Set> to
re-select the trace reference points (inner dots of the curve). Move the cursor to the exact
boundary position and press <Set> again to set the right place. Tap [Start Tracking] to start
tracking again.
6. Tap [Accept & Compute] to calculate and display the curve.
Adjust the parameters if necessary.
7. Tap [Bull’s Eye] to see the result.

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8. Tap [Data Export] to export analyzed data.

9. Tap [Exit] to exit.

6.15.2 Screen Display of Tissue Tracking QA

1 6

3 5

1 Displays image used to generate trace /

curve
2 Displays corresponding time of AVO /
(aortic valve open)/AVC (aortic valve
close)/MVO (mitral valve open)/
MVC (mitral valve close).

3 Display curve: Velocity/ Each curve on the image is matched with a certain segment in the
Displacement/Strain/Strain Rate. cardiac segmentation model (6), identified by different colors.
• Velocity curve: X-axis represents time (s); Y-axis represents
velocity (cm/s).
• Displacement curve: X-axis represents time (s); Y-axis
represents displacement (mm).
• Strain curve: X-axis represents time (s); Y-axis represents
deformation of the tissue (%).
• Strain-rate curve: X-axis represents time (s); Y-axis represents
strain by time (s-1).
4 Displays ECG trace /
5 Displays cardiac segmentation • In the figure, marks the peak position of the curve.
model, and each segment name is • Under tracking status, click on a segment in the cardiac
illustrated beneath the model. segmentation model. The segment has “X” mark and its
corresponding calculating is eliminated.
• Tap certain segment in the cardiac segmentation model, the
segment will turns grey and its corresponding curve no longer
displays.
• You can get the current X/Y axis value by moving the cursor
onto one point on the curve; and if you press <Set> at this time,
the frame marker will move to the spot.
The segment boundary color indicates the tracking quality.

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6 Displays measurement and • EDV: Maximum value of the end diastolic volume during the
calculation results trace.
• EDA: Maximum value of the end diastolic area (Left
Ventricular) during the trace.
• ESV: Maximum value of the end systolic volume (Left
Ventricular) during the trace.
• ESA: Maximum value of the end systolic area (Left Ventricular)
during the trace.
• FAC (for short axis section): Fractional Area Change= (EDA —
ESA)/EDA
• EF (for long axis section): Ejection fraction
• HR: Heart rate
• Global strain of all segments.
• Displays when strain rate curve is acquired.
• Global strain rate of all segments.
• Displays when strain rate curve rate is acquired.
Also on Bull’s Eye figure, the system displays TPSD value:
Time to Peak Standard Deviation (TPSD):
Where, standardized value of time to peak data: .
(N is the number of time to peak data) Average value of
standardized value of time to peak data: , and the standard
deviation is

6.15.3 Select Image and Cardiac Cycle

You can select images with a better image quality so as to guarantee the analysis result.

Switch the cine file

1. Tap [Review] to enter the review state on touch screen.
2. Double-click the target file.
3. The system closes current displayed file and switch to the newly selected file.

Switch cardiac cycle within the cine file

Tap [Circle] to select when opening a cine which includes multiple cardiac cycles.

6.15.4 Myocardial Boundary Tracing

Tracing
The system provides 2 kinds of tracing method for 2 kind of sections. Long axis section (A4C,
A2C, ALAX): 3-point method and manual tracing method are both available. Short axis section
(PSAX B, PSAX M, PSAX AP): only manual tracing is available.
• 3-point method
As shown in the following figure, after operation by pressing <Set> to place 3 points on the
image, the system generates the trace automatically.

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• Manual trace method

Press <Set> and move the cursor by using the trackball/trackpad along the boundary to add the
trace points gradually, after trace is finished, press <Set> twice to finish tracing.
NOTE:
At least 6 points should be determined by you before the system generates automated trace.
Press <Set> to make the traces on the image clockwise or anticlockwise.

Retracing
If current trace is not satisfactory, tap [Reload] on the touch screen to clear the trace and to start
another tracing.
During the tracing drawing, press <Clear> to clear already traced drawing.

Make fine adjustment to the trace

You can make fine adjustments to the trace after it is completed.
Perform the following procedure:
1. Under tracing curve adjusting status, the cursor turns into .
2. Move the cursor to the editable point, press <Set>.
3. Use the trackball/trackpad to drag the curve to desired position, press <Set> again to set the
point to the new position.
4. Repeat step 2~3 above to finish all points that need adjustment.

TIP:
Under tracking status, tap [Edit] on the touch screen to enter the status.

6.15.5 Basic Operations of TTQA

Switch among the operation controls
• [Start Tracking]: tap to start tracking.
• [Accept & Compute]: tap to start calculation and display the curve.
• [Exit]: tap to exit tissue tracking.
• [Parameter]: rotate to select the curve type.
• [Bull’s Eye]: touch to turn on/off bull’s eye and peak data table.
• [Auto Play]: change the speed of the play.

View Selection
Before tracing, touch the corresponding keys to select for the view.
• [A4C]: apical four chamber.

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• [A2C]: apical two chamber.

• [ALAX]: apical long-axis view, also called 3-chamber view.
• [PSAX B]: short axis view of base section, short axis view of mitral valve.
• [PSAX M]: short axis view of base section, short axis view of papillary muscle.
• [PSAX AP]: short axis view of apex.

Parameter Adjustment
• [Thickness]: adjusts the tracing thickness, i.e., the distance between the endocardium wall and
the tracking points on the epicardium.
• [Tracking Points]: adjusts the number of points within the segment.
• [Cycle]: select the next cycle.
• [Display Effect]: turns on/off the arrow vector graphical display of the myocardial movement.
• [Velocity Scale]: adjust the scale length of the velocity.
• [Display Style]: display the endometrial, the epicardium, the myocardial or all.
• [Tracking Cycles]: select the cycles to be tracked.
• [Average Cycles]: obtain the average parameter curves of the tissue.
• [Cycle Select]: select among different cycles.

Time Mark
According to the status of the current section, tap the corresponding key on the touch screen to
check the matching time.
• [AVO]: displays aortic valve open time.
• [AVC]: displays aortic valve closure time.
• [MVO]: displays mitral valve open time.
• [MVC]: displays mitral valve closure time.

Curve Display
Select [Parameter], the system provides different curves of different segments for observation.
• General
– Speed curve: The X-axis represents time (s); the Y-axis represents velocity (cm/s).
– Displacement curve: The X-axis represents time (s); the Y-axis represents displacement
(cm).
• Long axis section
– Volume: The X-axis represents time(s); the Y-axis represents volume (ml).
– Strain curve (Longitudinal, Transversal): The X-axis represents time (s); the Y-axis
represents strain deformation of the tissue (%).
– Strain-rate curve (Longitudinal, Transversal): The X-axis represents time (s); the Y-axis
represents strain by time (s-1).
• Short axis section
– Area curve: The X-axis represents time(s); the Y-axis represents area (cm2).
– Strain curve (Radial, Circumferential): The X-axis represents time (s); the Y-axis
represents strain deformation of the tissue (%).
– Strain-rate curve (Radial, Circumferential): The X-axis represents time (s); the Y-axis
represents strain by time (s-1).
– Circumferential Rotation curve: The X-axis represents time (s); the Y-axis represents
rotation of the tissue (Deg).

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– Circumferential Rotation Rate curve: The X-axis represents time (s); the Y-axis represents
rotation by time (Deg/s).

Torsion & Torsion Rate Curve

The system provides left ventricular torsion data based on short axis sections of PSAX AP and
PSAX B. Torsion is acquired by calculating difference of apex and base of the heart.
Torsion = PSAX AP Rot. - PSA XB Rot.

• The X-axis represents time (s).

• The Y-axis represents tortion by time (Deg/s).

6.15.6 Bulleye
After tracking, the system can display Bull’s Eye graph, so as to judge reverse movement or scope
of myocardium.
1. Tap [Bull’s Eye] on the touch screen to turn on the function:
You can acquire:
– Time to peak value and peak value of the 17 segments (similar to 16 segments);
– Display measurement result EDV/ESV/EF/TPSD.
2. Use [Parameter] on the touch screen to see different parameter bull’s eye graph.
“-” will display in the table to indicate those segments that are not well tracked.

6.15.7 Measurement/Comment
Under tissue tracking QA mode, only Time measurement is available. For details, please refer to
Operator’s Manual Advanced Volume.
Comments and Body Mark operations are the same as in other modes.

6.15.8 Data Export

The system provides data exporting function, so that you can export calculation result for analysis
(for instance, SPSS analysis).
Tap [Data Export] on the touch screen, to export analyzed data of each segment in .csv format.

6.16 Auto GA
NOTE:
Auto GA must be used with convex probe.

After acquired image(s) of gastric antrum, by freezing image and tapping the Auto GA button, the
feature shows boundary of gastric antrum and calculates the area of gastric antrum.
Perform the following procedure:
1. Scan and obtain the gastric antrum image and freeze the image.
2. Select [Auto GA], the system will automatically recognize and trace the target boundary to
calculate.
The calculation result is displayed on the screen.
3. If the calculation result is not satisfactory, adjust the trace to recalculate.

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a. Select the traced contour to activate the cursor.

b. Anchor the desired point on the traced contour.
c. Select and move the cursor to the desired position by trackball/trackpad.
d. Repeat steps b to c above to adjust more points if needed.
The calculation results display in real time.
4. Tap [Accept Results] to accept the result.
After accepting the result, if the accepted result is not satisfactory, tap [Remeasure] and repeat
step 3 above to update the result.
5. Select [Trend Curve] to check the trend curve of all the accepted results.

6.17 Auto DFR

The Auto DFR is used to estimate the diastolic function of left ventricular. E/A and E/ E' are the
indexes of diastolic function and can be automatically measured.
Perform the following procedure:
1. Select a phased probe (except TEE probes) and cardiac exam.
2. Acquire an Apical four-chamber image.
3. Select [Auto DFR].
If necessary, adjust the PW Doppler sample volume.
4. Select the desired calculation item (MV E/A, MV E/E' Septal, MV E/E' Lateral) to acquire the
results by auto calculation.
5. Press the Freeze button to freeze the image.
6. Select an appropriate heart cycle by using the trackball, and select [Accept Result] to accept
the calculation result.
If necessary, adjust the position of E or A peak point to fine tune the calculation result, and
then select [Accept Result].
7. Measurement results include Peak E-wave velocity, Peak A-wave velocity, MV E/A ratio,
Pulsed-wave TDI E' velocity and Mitral E/E' ratio.

6.18 Smart FHR OB1

This feature is to manually select ROI (region of interest) of fetal heart in B mode, and then
automatically calculate period of fetal heart motion and FHR (fetal heart rate).

NOTE:
• Different imaging presets or setups may affect the frame rate. Improve the frame rate by
adjusting the image parameters to ensure the frame rate is at least 20 frame per second.
• Place the ROI on the target area after the fetal heart position remains stable, and keep the fetal
heart located in the ROI box. When fetal heart remains inside the ROI placed by the operator,
its position is considered to be stable.

Perform the following procedure:

1. Perform B-mode scanning under OB1, EM OB, ABD or EM ABD exam mode.
2. Adjust the image parameters to obtain a good image.
3. Perform the following operation to enter Smart FHR OB1.

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– In real-time or frozen mode, select [Smart FHR OB1].

– Open a saved cine file. Select [Smart FHR OB1].
4. Select the fetal heart area to position the ROI. The fetal heart rate measurement result will be
displayed on the screen automatically.
If necessary, perform the following operation to update the measurement result.
Adjust the Region of Interest (ROI) if necessary:
– Select the corner (green dot) of the ROI and drag to change the size.
– Select inside the ROI box and drag to change the position.
In frozen mode, you can also use the start/end mark on the cine menu to reselect the time
period.
The measurement result is updated simultaneously.
5. Tap [Accept Result] to save the calculation result to the report.

6.19 AutoEF
Measure the diastole and diastole planes automatically.

TIP:
• Only cardiac exam mode supports this function.
• Recommend to connect ECG, capture the cine of standard A2C and A4C planes, and select
cardiac cycles which have the clear plane of the cardiac muscle and less interference to
perform AutoEF measure.

Measure items:

Item Description
LVLd (A2C) Left ventricular long-axis length at end diastole (A2C)
LVAd (A2C) Left ventricular long-axis area at end diastole (A2C)
LVLs (A2C) Left ventricular long-axis length at end systole (A2C)
LVAs (A2C) Left ventricular long-axis area at end systole (A2C)
LVLd (A4C) Left ventricular long-axis length at end diastole (A4C)
LVAd (A4C) Left ventricular long-axis area at end diastole (A4C)
LVLs (A4C) Left ventricular long-axis length at end systole (A4C)
LVAs (A4C) Left ventricular long-axis area at end systole (A4C)

Measurement Result:

Item Description
EDV (A2C/A4C/BP) End-diastolic Left Ventricular Volume
EDV Index (A2C/A4C/BP) End-diastolic Left Ventricular Volume Index
ESV (A2C/A4C/BP) End-systolic Left Ventricular Volume
ESV Index A2C/A4C/BP) End-systolic Left Ventricular Volume Index
SV (A2C/A4C/BP) Stroke Volume

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Item Description
SI (A2C/A4C/BP) SV Index
EF (A2C/A4C/BP) Ejection Fraction
CO (A2C/A4C/BP) Cardiac Output
CI (A2C/A4C/BP) Cardiac output index

Perform the following procedure:

1. Select the [AutoEF] in the measurement menu.
2. In apical two-chamber view, measure the following parameters:
– Left ventricular endocardium at end-diastolic, the EDV (A2C), SV (A2C), EF (A2C) is
obtained automatically.
– Left ventricular endocardium at end-systolic, the ESV (A2C), SV (A2C), EF (A2C) is
obtained automatically.
3. In apical four-chamber view, measure the following parameters:
– Left ventricular endocardium at end-diastolic, the EDV (A4C), SV (A4C), EF (A4C) is
obtained automatically.
– Left ventricular endocardium at end-systolic, the ESV (A4C), SV (A4C), EF (A4C) is
obtained automatically.
If the height and weight have already been entered, the SI, EDV Index and ESV Index are
calculated.
4. Select the HR source: ECG or entered.
ECG obtains the HR automatically. If ECG is not connected, it should start HR on the menu.
The CO and CI are calculated automatically using the entered height and weight values.

6.20 Smart Bladder

NOTE:
• Smart Bladder must be used with convex-wide probe.
• Smart Bladder is available in Single/Dual B imaging mode.

Function: measure the volume of the urine in the bladder.

1. Select an appropriate probe and exam mode.
2. Scan and obtain the image of the bladder.
3. Press <Freeze> to freeze the image and tap [Smart Bladder] in the measurement menu.
[XS] is selected by default and two diameters d1 and d2 (perpendicular to each other by
default) of the transverse section are recognized by the system.
NOTE:
[Sag] can be selected manually if scan and obtain the longitudinal section image of the
bladder.
4. If the current result is satisfactory, tap [Accept Result] or press <Set> to save the result.
Or, if the result is not satisfactory:
a. Tap [Auto Detect] to update the result.

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b. Tap [Accept Result] to save the result.

5. Press <Freeze> to unfreeze the image.
6. Tap [Smart Bladder]. Scan and obtain the longitudinal section image of the bladder.
The diameter d3 is recognized by the system automatically.
7. If the current result is satisfactory, tap [Accept Result] or press <Set> to save the result.
Or, if the result is not satisfactory:
a. Tap [Auto Detect] to update the result.
b. Tap [Accept Result] to save the result.
8. The measurement results will be displayed in the results window.

6.21 iWorks (Auto Workflow Protocol)

The main objective of ultrasound workflow automation (iWorks) is to speed up exam times and
reduce the excessive number of user interface manual key strokes that can lead to repetitive strain
injuries over time. It automates a clinical workflow in common exam protocols in a logical “step by
step” manner. It also prevents missing important parts of examinations as well as decreasing exam
times.
A Protocol Event contains series workflow events (annotation comments, body marks and
measurements) and image modal commands to assist the user in routine ultrasound examinations.

TIP:
• The system provides different protocol events based on the different application regions.
• iWorks is an option.

Perform the following procedure:

1. Input the patient information.
2. Tap [iWorks] on the touch screen or press the user-defined key for “iWorks” to enter the
protocol selection screen, and tap the corresponding protocol button to enter the status.
After the system enters the iWorks screen, the available protocol is displayed on the right of
the screen.
3. Perform the scanning and saving according to the screen prompt.
4. Perform measurements or add comments/body marks to the image according to the screen
prompt.
5. After a view scanning is complete, press the user-defined save key to switch to the next view
according to the screen prompt.
6. Repeat steps 3 to 5 to acquire all the necessary images.
– If a pathology is discovered, tap [Insert] to select a protocol outside of the normal routine
to start scanning.
– Tap [Repeat] to add a copy of the selected view to work on if necessary.
– Tap [Next] or [Previous] to skip to a particular view you are interested in.
– Tap [Replace] to delete images and operations for the selected view and restart operations
on that view.
– Tap [Delete] to delete the currently activated view.
– Tap [Suspend] to start a manual scan when an unusual or atypical workflow is required,
and tap [Resume iWorks] to restart the iWorks procedure.

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7. After all views are finished, the system will prompt you to exit iWorks. Tap [Yes] to exit.

6.21.1 Screen Display

Monitor Display
The monitor displays the following screen:

1 Displays the protocol name, and the number of views contained.

2 Displays the view steps in the protocol.
The current active view with a solid frame around the image.

Touchscreen Display
The touchscreen displays the following screen:

6.21.2 View Operation

In iWorks status, you can perform view selection, repeat, replacement and delete operations using
the touch screen.
For some views, the system switches to the relevant imaging modes if necessary.

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The comment for the current view has been automatically added to the bottom-left corner of the
image, ready for you to scan the specified anatomy.

View Selection
Tap [Prev]/[Next] to select the view to be scanned. The current view is surrounded by a solid frame.

View Operation
In the current active view, you can perform image scanning, measurements, and adding comments
and body marks, etc. Operations are the same as those for manual operation. See the relevant
chapters for details.

Repeat View
If necessary, tap [Repeat] to insert another template of the current view. You can then perform an
extra examination.

View Replacement
The previous image will be deleted and replaced by the new image.

Delete View
Tap [Prev]/[Next] to select the view to be deleted. Tap [Delete] to delete the selected view.

6.21.3 Manual Examination

Suspend - Exit the protocol so the user can run the system manually. This is used when an unusual
or atypical workflow is required.
You can run the system manually if necessary.
• Start manual examination: tap [Suspend] to pause the current iWorks protocol. The system
enters manual examination status.
• Return to iWorks: tap [Resume iWorks] to return to automated status. You can continue the
previous iWorks scan.

6.21.4 Insert
Insert is a specialized protocol event within iWorks and iWorks OB. It assists with the workflow for
documenting and measuring common pathological (disease) states (i.e. Mass, Cyst, Stenosis,
Thrombus) that occurs outside a routine, normal examination.
Tap [Insert] on the touch screen to enter the status.
Select the necessary protocol and the system adds the protocol events to the current protocol.
Perform measurements or add comments/body marks to the image if necessary.

6.22 Quickly Saving Image Settings

TIP:
It is unavailable for frozen dual-probe mode.

Perform the following procedure:

1. Adjust parameters to optimize the image.
2. Select [Probe] > [QSave] or press the user-defined key for “QSave” to enter the QSave dialog
box.

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3. Click [Show Parameter] to view the image parameter of the current exam mode and the probe.
4. Click [Advanced] to set the following items if needed:
– Set the value to TIC/TIB/TIS.
– Enable the M-mark line.
The M-mark line always appears after being set when entering PW/M/TVM mode for
once. Press <PW>/<M> to enter the corresponding mode one time.
This function is unavailable for frozen dual-probe mode.
5. To save image parameters:
– Click [Save] to save the current image values for the current exam mode of the certain
probe.
– Click [Create] to save the current image parameters, measurements, comments, body
mark settings to the exam mode. The system will ask for a new name of the exam.
– Click [Restore] to restore the probe and exam mode to factory settings.

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7 Smart 3D

The operator moves the probe to change its position/angle when performing the scanning. After the
scanning, the system carries out image reconstruction, and then displays a single frame of 3D
image.

NOTE:
Smart 3D imaging is largely environment-dependent, so the images obtained are provided for
reference only, not for confirming a diagnosis.

TIP:
Smart 3D is an option.

7.1 Overview
The ordinary 2D imaging has the limitations on viewing the overall structure and different planes of
the target. However, 3D imaging can obtain the reference information by overall observation.

7.1.1 Terms
View point

• Volume data: to obtain the data collection of three-dimensional object via the sequence
reconstruction to two-dimensional object.
• 3D image Volume Rendering (VR): the 3D image on the screen.
• View point: the position for viewing volume data/3D image.
• MultiPlaner Rendering (MPR): a tangent plane of the 3D image that obtained by algorithm.Of
which, XY-paralleled plane is C-plane, XZ-paralleled plane is B-plane, and YZ-paralleled
plane is A-plane.YZ-paralleled plane is B-section. The probe is moved along the X-axis.
• ROI (Region of Interest): a volume box used to determine the height and width of scanning
volume.

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7 Smart 3D

• VOI (Volume of Interest): a volume box used to display 3D image (VR) by adjusting
interesting region in MPR.

7.1.2 ROI and VOI

After the system enters 3D imaging, a B image with ROI displays on the screen. A line (shown in
the following figure) that shows the upper edge position of VOI is inside ROI.

1 2D image
2 ROI
3 Cut plane

Define the ROI and curved VOI:

NOTE:
• To define a ROI, please remove the useless data as to reduce the volume data and shorten the
time for image storing, processing and reconstruction.
• Set ROI on the 2D image with the largest section area of the fetal face.
• Set ROI a little larger than the fetal head.

Perform the following procedure:

1. Press the right <Set> key to toggle among setting the ROI position, size or curved VOI.
2. Use the trackball/trackpad to change the ROI size, position and curved VOI,
3. Press the left <set> key to adjust VOI angle.
Depending on the view direction, the orientation and the shape (line or dot) of curved VOI vary:

View Curved VOI

U/D At the upper part of curved VOI
D/U At the lower part of curved VOI
L/R At the left part of curved VOI
R/L At the right part of curved VOI
F/B Displays as a dot
B/F Displays as a dot

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 7 Smart 3D

7.1.3 Render Mode

Surface
Set 3D image rendering mode as Surface.
This is helpful for surface imaging, such as fetus face/hand or foot.

TIP:
You may have to adjust the threshold to obtain a clear body boundary.

Max
Set Max as 3D image rendering mode, displays the maximum echo intensity in the observation
direction.
This is helpful for viewing bony structures.

Min
Set Min as 3D image rendering mode. Display the minimum echo intensity in the observation
direction.
This is helpful for viewing vessels and hollow structures.

X Ray
Set X-ray as 3D image rendering mode. Display the average value of all gray values in the ROI.
This is used for imaging tissues with different structure inside or tissues with tumor.

7.1.4 MPR
MPR represents three different views of 3D image.
In the quad display format view, the screen displays 3 MPRs (A, B and C) and the 3D image.

A B

A window B window

C 3D

C window 3D window (VR)

A, B, C sectional images are corresponding to the following sections of 3D image.

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• Section A: corresponds to the 2D image in B mode.Section A is the sagittal section in fetal face
up posture, as shown in the figure A above.
• Section B: it is the horizontal section in fetal face up posture, as shown in the figure B above.
• Section C: it is the coronal section in fetal face up posture, as shown in the figure C above.
The upper part of the 3D image in the 3D window is corresponding to the orientation mark on the
probe, if the fetal posture is head down (orientating the mother’s feet), and the orientation mark is
orientating the mother’s head, then the fetus posture is head down in the 3D image, you can make
the fetus head up by rotating the 3D image by taping [180°] on the touch screen.

CAUTION
The ultrasound images are provided for reference only, not for confirming a
diagnosis. Please use caution to avoid misdiagnosis.

7.1.5 Wire cage

When you view a 3D image on the display monitor, it’s sometimes difficult to recognize the
orientation. The system displays a three-dimensional drawing to illustrate the orientation for help.
Of which, the blue plane presents the image acquisition where started, while the red plane presents
the image acquisition where ended. Besides, a yellow plane in the wire cage presents the position of
the MPR.

7.2 Note before Use

The quality of images reconstructed in the freehand 3D mode is closely related to the fetal
condition, angle of a B tangent plane and scanning technique. The following Smart 3D description
uses the fetal face imaging as an example, the other parts imaging are same as 3D imaging.

NOTE:
• In accordance with the ALARA (As Low As Reasonably Achievable) principle, please try to
short the sweeping time after a good 3D imaging is obtained.

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• A region with qualified image in B mode may not be optimal for 3D imaging. E.g. adequate
AF isolation for one section plane of 2D image doesn’t mean the whole desired region is
isolated by AF for 3D imaging.
• More practices are needed for a high success of qualified 3D imaging.
• Even with good imaging condition, to acquire an approving 3D image may need more than one
scanning.

Fetal Condition
• Gestational age
Fetuses of 24~30 weeks old are the most appropriate to 3D imaging.
• Fetal body posture
Recommended: Cephalic face up (figure a) or face aside (figure b); NOT recommended:
Cephalic face down (figure c).

• Amniotic fluid (AF) isolation

– The region desired is isolated by amniotic fluid adequately.
– The region for imaging is not covered by limbs or umbilical cord.
• The fetus keeps still. If there is a fetal movement, you need a rescan when the fetus is still.

Angle of a B tangent plane

The optimum tangent plane to the fetal face 3D imaging is the sagittal section of the face. To
ensure high image quality, you’d better scan maximum face area and keep edge continuity.

Image quality in B mode (2D image quality)

Before entering 3D capture, optimize the B mode image to ensure:
• High contrast between the desired region and the amniotic fluid surrounded.
• Clear boundary of the desired region.
• Low noise of the amniotic fluid area.

Scanning technique (only for Smart 3D)

• Stability: body, arm and wrist must move smoothly, otherwise, the restructured 3D image
distorts.
• Slowness: Move or rotate the transducer slowly. The speed of linear scan is about 2 cm/s and
the rotation rate of the fan scan is about 10°/s ~ 15°/s.
• Evenness: move or rotate the transducer at a steady speed or rate.
• Method
Capture images using Linear scan or Rocked scan.

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– Linear scanning
Move the probe across the surface. See the following figure.

– Rocked scanning
Rotate the probe once from the left to the right side (or from the right to the left) to include
the entire desired region. See the following figure.

Scanning plane and probe movement

Move the probe across the body surface.
The arrow in the figure below indicates the movement of the probe.
You can move the probe in the opposite direction to the arrow.

7.2.1 Smart 3D Image Acquisition

NOTE:
In Smart 3D image scanning, if the probe orientation mark is oriented to the operator’s finger,
perform the scan from right to left in linear scan, or rotate the probe from left to right in rocked
scanning. Otherwise, the VR direction will be wrong.

Perform the following procedure:

1. Select the proper probe and exam mode; make sure there is sufficient gel on the probe for
scanning.

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2. Obtain a 2D image, and optimize the image if necessary.

3. Press the user-defined key for “Smart 3D” to enter Smart 3D imaging mode.
– Adjust ROI size and position and the position of VOI.
– Select the render mode.
– Set the scan method and the movement of the probe.
4. Press <Update> to start 3D imaging.
The system enters into 3D image review status when the acquisition is completed; or, you can
finish the acquisition ahead by pressing <Freeze> or <Update>.
5. Exit Smart 3D
– Press <Update> or <Freeze> to return to Smart 3D acquisition preparation status.
– Or press <B> or the user-defined key for “Smart 3D” to exit the mode.

7.2.2 Smart 3D Image Viewing

Activate MPR
Select [Ref. Image] > [A], [B], [C] or [VR] to activate sectional plane image (MPR) or 3D image
(VR).

MPR Viewing
In actual display, different colors of the window box and the section line are used to identify the
section A, B and C.
• The color of window A is blue, and the color of the lines (representing section A) displayed in
the other two windows is blue as well.
• The color of window B is yellow, and the color of the lines (representing section B) displayed
in the other two windows is yellow as well.
• The color of window C is orange, and the color of the lines (representing section C) displayed
in the other two windows is orange as well.
Positions of the other two sectional planes are indicated in the selected plane. You can roll the track
ball to change the position.

Sectional A Sectional B Sectional C

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MPR Only
Select [Display Format] > [MPR Only] on the touch screen to display section images. And the
adjustable image parameters are changed into MPR parameters automatically.
Only A, B and C section images are displayed, and 3D image is not displayed.

Asymmetric
Select [Display Format] > [A4:1] on the touch screen to display section images and 3D image.

View Direction
The Region of Interest (ROI) contains the section of the volume you want to render. You can adjust
the view direction of the ROI.
The system supports the observation of 3D image from 6 directions.

a. Up/Down b. Down/Up

c. Left/Right d. Right/Left

e. Front/Back f. Back/Front
Tap [Up/Down], [Left/Right] or [Front/Back] to select the direction of the figure a, c and e.
Tap [Flip] on the first page to observe by the converse direction of the current direction, which is
equivalent of the 180° rotation of current VOI, as shown in the figure b, d, e and f.

Adjust VOI
Adjusting the VOI box size and position is to select the volume data needed to restructure the 3D
image and improve the reconstruction effect.
• VOI On
3D image (VR) image displays VOI information.
a. In image viewing status, tap [VOI] to be “On”.
b. Select a desired section plane by tapping [Ref. Image] > [A], [B] or [C] or [VR].

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c. Use the trackball/trackpad to adjust VOI position, size and curved VOI, and press <Set>
to toggle among the adjusting status.
• VOI Off
3D image (VR) image displays ROI information.
Tap [VOI] to be Off, then the ROI image is displayed on the screen, use the trackball/trackpad
to observe section images.

Accept VOI
This function is usually used for section image observation and to determine the relative position of
the section image to the VR.
1. Tap [Accept VOI].
2. Select a desired MPR image by tapping [Ref. Image] > [A], [B] or [C].
3. Use the trackball/trackpad to view the current active section image, and the other section
images change correspondingly
In Accept VOI status, when the 3D image is active or the section image which is perpendicular to
the view direction is active, center point of the 3D image displays, and you can adjust the position
by using the trackball/trackpad.

The adjustment of Rendering Parameters

In image viewing status, you can render the image by adjusting the relevant parameters.
Tap [VR] or [MPR] on the touch screen to select the VR parameters or MPR parameters.
• When [VR] button is highlighted, adjust parameters of 3D image (VR).
• When [MPR] button is highlighted, adjust parameters of sectional image.
You can adjust:

Item Description
Threshold Set the threshold for 3D image rendering. 3D image is rendered on the
signal above thresholds by eliminating noise via the Threshold
parameter. Lower threshold can eliminate lower range noises and echo,
which will contribute to a clearer and smoother image.
Available only in Surface rendering mode.
Opacity Adjust the transparency value for 3D image rendering. It implies the
transparency of the light. The higher the value is, the tougher the
surface becomes.
The lower the number is, the more transparent the gray scale
information will be.
Available only in Surface rendering mode.
Smooth Set the smoothness of 3D image.
NOTE:
Insufficient smoothness can result in a fuzzy image; however, too
much smoothness will lead to image distortion.
Brightness Set the brightness of image.
NOTE:
The adjustment is for 3D (VR) and MPR.

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Item Description
Contrast Set the contrast scale of the image.
As long as the contrast becomes larger, the bright spot and dark spot on
the image change as well.
NOTE:
The adjustment is for 3D (VR) and MPR.
Tint Enable/disable tint map. The color of image change according the tint
value.
Quick Rotation Rotate the 3D image quickly.
iClear Use the 3D self-adapation filter to strengthen the space continuity of the
tissue structure, and provide speckle suppression, and improve the
image contrast effect, so as to optimize the image data.
Adjust iClear to optimize MPR image.
VR Refine Optimize the signal-noise ratio and the contrast of VR image.
MagiClean Reduce the noise and keep the boundary of the image more clearly.
NOTE:
Available only in Surface rendering mode.
Depth VR Superimpose the tint map basic on the VR image to improve the
stereoscopic sensation and the contrast of the image.
Thickness Adjust the render thickness of MPR.

Reset Curve
Do one of the following to reset the curve:

Item Description
Ori To reset the volume rotation, shifting and zooming of 3D image to
original status.
All To reset the parameters, rendering rotation, VOI and image effect.
Reset Curve To reset the curve to be the original beeline.

Render Mode
Set 3D image rendering mode.
The rendering manners can be applied to inversion mode.

Inversion
This function is to inverse the echo of the 3D image, so as to enhance observation for low-echo
region, applicable for vessel, cyst and etc.
When the Inversion is turned on, the rendering mode parameters change into the corresponding
inversion parameters.
Vessel shape is correct with the capture target. The vessel wall is smooth and clear.

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Rotate the Image

NOTE:
You can view the back of the VR by rotating it 180°. The back view image may not be as vivid as
the front. (Here we call the initial view of the VR the “front”). It is recommended to re-capture
rather than rotate the VR if a certain desired region is obscured in the VR.

• Axial rotation
Axial rotation is to rotate the 3D image around the X, Y or Z axis. Use [X Axis], [Y Axis] and
[Z Axis] buttons to rotate the image along the selected axis:
– Tap the left part of the button, or rotate the multi-functional knob anticlockwise: the image
rotates left along the selected axis.
– Tap the right part of the button or rotate the multi-functional knob clockwise: the image
rotates right along the selected axis.
• Auto Rotation
a. In 3D viewing mode, tap [Tools] > [Auto Rot.] to enter into auto rotation preparation
state.
b. Tap [Left/Right] or [Up/Down] to set the auto rotation direction
c. Set Start position and End position:
Start position: Use the trackball/trackpad to view to a certain position, tap [Set Start].
End position: Use the trackball/trackpad to view to a certain position, tap [Set End]
d. Set the auto rotation increment: rotate the knob under the [Increment].
e. Tap [Off] to start auto rotation.
Use [Speed] to adjust the rotation speed
Tap [SE/SE] for single direction rotation; tap [SE/ES] for bidirectional rotation.

Surface Enhancement
This function is to make the edge structure of the image and surface details clearer, so as to enhance
the overall contrast.
Tap [Surf. ENH] to adjust the enhancement level, the higher the level is, the clearer the edge
structure of the image is.
When the level is higher than 0 and [Move Light] is highlighted, image close to the light source is
clearer, and image away from the light source is darker.

Move the light

This function is to adjust the position of the light source as VR is considered. The image becomes
clearer as keeping closer to the light.
Use the trackball/trackpad and change the light position to make fine adjustments after tapping
[Move Light].

Sync
This function is to switch the direction of the image to the direction that is perpendicular to the
current active plane, so as to get a better observation.

Comments and Body Marks

Add comments and body marks to the MPR and VR.
The operations are the same with these in B mode.

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Image Editing
Image cutting is a more elaborate function than VOI adjusting to optimize the 3D by clipping
(removing) the part blocked the region of interests.

TIP:
• In image cutting status, image parameter can not be edited. There displays a cutting cursor + or
an eraser cursor , and the system enters “Accept VOI” status.
• The editing function is only available on 3D image.

Perform the following procedure:

1. Enter image cutting status by taping “Tools” tab page.
2. Select an edit/erase tool:

Item Description Operation

Polygon Allows you to trace a polygon on Follow the steps below:
the image you want to cut. 1. Press <Set> to position the start point.
2. Use the trackball/trackpad to set a region
and press <Set> to trace the region.
When the start point and the end point
coincide, the region is selected or you can
press <Set> twice to finish tracing.
3. Move the cursor to the region you want to
edit and press <Set> again to edit.
Contour Allows you to trace the portion of Follow the steps below:
the image you want to cut. 1. Press <Set> to position the start point.
2. Use the trackball/trackpad to trace the
region.
When the start point and the end point
coincide, the region is selected or you can
press <Set> twice to finish tracing.
3. Move the cursor to the region you want to
edit and press <Set> again to edit.
Rectangle Displays a box which can be used Follow the steps below:
to define the portion of the image 1. Press <Set> to fix the rectangle position.
you want to cut.
2. Use the trackball/trackpad to change the
size, and press <Set> again to finish
rectangle drawing.
3. Move the cursor to the region you want to
edit and press <Set> again to edit.

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Item Description Operation

Line Use a multi-point line to trace the Follow the steps below:
boundary quickly. 1. Press <Set> to position the start point and
the system will display a reference line.
2. Use the trackball/trackpad to set the line
orientation and press <Set> to start
drawing, press <Set> when ends are
necessary; press <Set> twice to finish
drawing.
3. Move the cursor to the region you want to
edit and press <Set> again to edit.
Soft Eraser Applies to softer or smoother Follow the steps below:
boundary within a small range of 1. Press <Set> to position the start point.
the image.
2. Use [Eraser Diam.] to adjust the eraser size
Hard Eraser Applies to a distinct boundary of if needed.
within a wider range of the image. 3. Use the trackball/trackpad to select the
Eraser Diam. As the eraser erases the image by region, and press <Set> when ends are
means of sphere, you can adjust required.
the size so as to adjust the erased You can repeat the step to erase all parts
area and depth. blocking the interesting region.
The eraser sphere center has a
more distinct effect of clearing
compared to other parts.
Undo To undo the last cut only. /
Undo All To undo all cuts since you entered /
image edit mode.

Section image (MPR) measurement

2D related measurement can be performed. For details, please refer to Advanced Volume.

TIP:
Capturing preparation does not support the measurement.

Image Saving
• Image saving
In the 3D Review mode, press <Save> key (with user-defined saving function) to save the
current image and volume data to the patient information management system in the set
format.
• Image review
Open an image file to enter the image review mode. In this mode, you can perform the same
operations as what you can in review mode.

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8 Strain Elastography

CAUTION
It is provided for reference, not for confirming a diagnosis.

TIP:
• The strain elastography is an option.
• Select an appropriate probe before performing elastography imaging scan, see “16.1 Probes”.

It is produced based on the slight manual-pressure or human respiration in 2D real-time mode. The
tissue hardness of the mass can be determined by the image color and brightness. Besides, the
relative tissue hardness is displayed in quantitative manners.

8.1 Basic Procedure for Strain Elastography

Perform the following procedure:
1. Perform 2D scan to locate the region.
2. Tap [Elasto] on the touch screen or press the user-defined key for “Elasto” to enter the
elastography mode.
The system displays two dual B+E windows in real time. The left one is 2D image, and the
right one is elasto image.
3. Adjust ROI according to the lesion size.
Press <Set> to switch between the solid line and the dotted line status.
– When the ROI box is solid line, use the trackball/trackpad to change its position.
– When the ROI box is dotted line, use the trackball/trackpad to change the size.
4. Press the probe according to the experiences and actual situation.
The screen displays the pressure curve in real-time:

Where, the X-axis represents time and Y-axis represents pressure.

5. Adjust the image parameters to obtain optimized image and necessary information.
6. Press <B> or tap [Elasto] to exit, and then return to B mode.

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8.2 Image Parameters

Smooth
Adjust the smooth feature of the Elasto image.

Opacity
Adjust the opacity feature of the Elasto image.

Invert
Invert the E color bar and therefore invert the colors of benign and malignant tissue.

Display Format
Adjust the display format of ultrasound image and the Elasto image.
Tap [H 1:1], [V 1:1], [Full] on the touch screen to adjust.
The system provides 3 types of display format:
• H 1:1: Right and left display (the real-time ultrasound image appears on the left, and the elasto
image appears on the right);
• V 1:1: Up down display (the elasto image appears above, and the real-time ultrasound image
appears below).
• Full: The elasto image only displayed.

Map
Select different maps for observation.

Strain mode
Affect the display effect of adjusting dynamic range.

Dynamic Range
Adjust contrast resolution of an image.
The real-time dynamic range value is displayed on the image parameter area in the upper left corner
of the screen.

E Sensitivity
Increase the image palpability.

Strain Scale
Adjust the bar height of the pressure hint curve to keep the average height of the hint bar on proper
position.

Map Position
Adjust the up/down position of the map.

8.3 Mass Measurement

Press <Measure> to enter measurement status.
You can measure shell thick, strain ratio, strain-hist, etc.
For details, see Advanced Volume.

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9 Contrast Imaging

The contrast imaging is used in conjunction with ultrasound contrast agents to enhance imaging of
blood flow and microcirculation. Injected contrast agents re-emit incident acoustic energy at a
harmonic frequency much more efficient than the surrounding tissue. Blood containing the contrast
agent stands out brightly against a dark background of normal tissue.

CAUTION
• Set MI index by instructions in the contrast agent accompanied manual.
• Read contrast agent accompanied manual carefully before using contrast
function.

NOTE:
• Make sure to finish parameter setting before injecting the agent into the patient to avoid
affecting image consistency. This is because the acting time of the agent is limited.
• The applied contrast agency should be compliant with the relevant local regulations.

TIP:
• Contrast imaging is an option.
• Select an appropriate probe for Contrast Imaging, see “16.1 Probes”.

9.1 Basic Procedures for Contrast Imaging

Perform the following procedure:
1. Select an appropriate probe, and perform 2D imaging to obtain the target image, and then fix
the probe.
2. Tap [Contrast] or press the user-defined key for “Contrast” to enter the contrast imaging mode.
3. Adjust the acoustic power experientially to obtain a good image.
Tap [Dual Live] to be “On” to activate the dual live function. Observe the tissue image to find
the target view.
4. Inject the contrast agent, and set [Timer 1] at “ON” to start the contrast timing. When the timer
begins to work, the time will be displayed on the screen.
5. Observe the image, use the touch screen button of [Pro Capture] and [Retro Capture] or the
user-defined key to save the images.
Press <Freeze> to end the live capture.
Perform several live captures if there are more than one interested sections.
6. At the end of a contrast imaging, set [Timer 1] at “OFF” to exit the timing function.
Perform steps 3-6 if necessary.

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For every single contrast imaging procedure, use [Timer 2] for timing.
If necessary, activate destruction function by tapping [Destruct] at “ON” to destruct the micro-
bubbles left by the last contrast imaging; or to observe the reinfusion effect in a continuous
agent injecting process.
7. Exit contrast imaging.
Press <B> button to return to B mode.

9.2 Left Ventricular Opacification

TIP:
LVO contrast imaging is an option.

Perform the following procedure:

1. Acquire ECG signal.
2. Select an appropriate probe and LVO exam mode.
3. Workflow of LVO is similar to abdomen contrast imaging, see “9.1 Basic Procedures for
Contrast Imaging”.

9.3 Low MI Contrast Imaging

TIP:
Low MI contrast imaging is an option.

This feature enhances echo reflection by using contrast agent to perform myocardial analysis based
on echocardiography technique.
Perform the following procedure:
1. Acquire ECG signal.
2. Select an appropriate probe and cardiac exam mode.
3. Workflow of Low MI Contrast imaging is similar to abdomen contrast imaging, see “9.1 Basic
Procedures for Contrast Imaging”.

9.4 Image Parameters

When entering contrast imaging mode, the screen displays the contrast image, and if [Dual Live]
item on the touch screen is “ON”, both the contrast image (marked with “C”) and tissue image
(marked with “T”) are displayed (the two window position can be changed).
Parameters in Contrast mode are similar to those in B mode; please refer to B chapter for details,
special Contrast imaging parameters are introduced in the following.

Timer

NOTE:
The starting time displayed may be inconsistent with the actual one due to system error or some
other man-made mistakes; please check the agent-injecting time.

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The two timers are used to record total time of contrast imaging and single time of one contrast
exam.
After the image is frozen, Timer 1 is still timing, and after unfreezing the image, the corresponding
time can be seen.
Timer 2 stops timing when one contrast exam is frozen, and after unfreezing the image, the Timer 2
is off.
Set [Timer 1] as “ON” to start the timing at the moment you inject the contrast agent. Here, the
screen displays the times at the lower corner.

Micro-bubble Destruction

CAUTION
Use the contrast imaging according to the residual level of the micro-bubbles,
using contrast imaging continuously may result in human harm.

Destruct the micro-bubbles left by the last contrast imaging; or to observe the reinfusion effect in a
continuous agent injecting process.
Tap [Destruct] on the touch screen to enable the micro-bubble destruction function:
• DestructAP: Adjust the destruct acoustic power via the touch screen.
• Destruct Time: Adjust the destruct time via the touch screen.

Dual Live
In live mode or freeze mode, set touch screen item [Dual Live] as “ON” to enable dual live
function. Both the contrast mode and tissue mode are displayed. The THI and B image are
displayed on the screen if the [Dual Live] is enabled.

TIP:
• In dual live mode, the screen displays the contrast image and tissue image
• In freeze mode, there displays only one cine review progress bar as the contrast image and
tissue image are reviewed synchronously.

Mix Map
This function is to mix the contrast image with the tissue image, so that interested contrast regions
can be located.
Use [Mix] to select different mixing mode.
• When dual live function is on, you can see the mixed effect on the contrast image.
• When dual live function is off, you can see the mixed effect on the full screen image.
Select the map through the [Mix Map] item.

iTouch
On contrast status, you can also get a better image effect by using iTouch function.
1. Press <iTouch> on the control panel to turn on the function.
The symbol of iTouch will be displayed in the image parameter area once press <iTouch>.
2. Select different levels of iTouch effect through [iTouch] on the touch screen.
3. Long press <iTouch> to exit the function.

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9.5 Image Saving

• Live capture
In live mode, you can save the interested images by tapping [Pro Capture] and [Retro Capture].
• Cine saving
In live mode, press <Freeze> on the control panel to enter cine review status.

9.6 Micro Flow Enhancement

MFE superimposes and processes multiple frames of contrast image during the cycle; it indicates
tiny vessel structures in detail by recording and imaging microbubbles.

TIP:
• MFE imaging is available only for real-time imaging or cine file of auto review mode. If a
MFE cine is reviewed manually, MFE effect cannot be displayed.
• In MFE status, patient should lie down and hold breath, and transducer should be kept still.

Perform the following procedure:

1. During real-time scanning, tap [MFE] on the touch screen to start MFE imaging.
2. Use [MFE Period] on the touch screen to select different imaging period suitable for current
flow. Where, MAX is the maximum superimposing effect.

9.7 Contrast Imaging QA

CAUTION
Contrast Imaging QA images are provided for reference only, not for confirming
a diagnosis.

TIP:
• In case of inaccuracy of the data, do not adjust the depth and the pan-zoom when saving the
cine.
• If the contrast signal inside the selected ROI does not meet the requirements of gamma fitting
condition, that is the bulleting injection, curve fitting may not be available.

Contrast Imaging QA adopts time-intensity analysis to obtain perfusion quantification information

of velocity flow. This is usually performed on both suspected tissue and normal tissue to get
specific information of the suspected tissue.

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Figure 9-1 Contrast QA Screen

1 Contrast cineloop Sample area: indicates sampling position of the analysis curve. The
window sample area is color-coded, 8 (maximum) sample areas can be
indicated.
2 B cineloop window Sample areas are linked in the contrast cineloop window and B
cineloop window.
3 Time-intensity curve • Y axis represents the intensity (unit: dB), while X axis represents
the time (unit: s).
• Frame marker: a white line that is perpendicular to the X axis, can
be moved horizontally left to right (right to left) by using the
trackball/trackpad.
• Click the check box beside the ROI to set if to hide or to display the
QA curve.
• You can get the current X/Y axis value by moving the cursor onto
one point on the curve; and if you press <Set> at this time, the
frame marker will move to the spot.

Perform the following procedure:

1. Perform image scanning, freeze the image and select a range of images for analysis; or select a
desired cine loop from the stored images.
The system set the starting time and ending time of the cine to be first frame and last frame of
QA analysis range.
2. Review the image to a desired frame.
3. Tap [Contrast QA] on the touch screen to activate the function.
4. Mark out the interested part (ROI).
Up to 8 ROIs can be saved on the reference image, with the corresponding eight traces plotted
simultaneously on the graph. Each ROI display has a different color, and its corresponding
trace data is plotted using that same color.

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a. Use [ROI Type] to select the method for determining the shapes of the sample area: Trace
ROI and Ellipse ROI.
The cursor is evolved in the image review area.
b. Use the trackball/trackpad to position the caliper on the reference image at the start point.
Press <Set> to fix the start point.

Trace ROI Follow the steps below:

1. Press <Set> key to fix the starting point.
2. Press <Set> key, and use the trackball/trackpad to depict the ROI.
Press <Clear> to cancel the last point.
The system automatically links the start point to the end point by
drawing a straight line between them.
3. When a suitable ROI has been drawn, confirm the ROI by double
pressing <Set>.
Ellipse ROI Follow the steps below:
1. Use the trackball/trackpad to position the caliper on the reference image
at the start point. Press <Set> to fix the start point.
2. Trace the outline of the desired ROI by moving the cursor with the
trackball/trackpad.
3. Press <Set> to fix the end point, and use trackball/trackpad to depict the
ROI. When a suitable ROI has been drawn, confirm the ROI by pressing
<Set> key.

– Press <Clear> key to clear out the last ROI.

– Tap [Delete All] on the touch screen to clear out all ROIs.
The corresponding traces for the deleted ROIs are erased from the plot.
– Tap [Copy ROI] to create a new ROI similar to the current or latest added ROI
5. Tap [Motion Tracking] to enable the Motion Tracking function.
This function provides a motion compensated ROI as precise time-intensity information can be
acquired using active tracking. It can enhance the calculation accuracy as reducing the impact
of probe or patient respiratory movement.
6. If necessary, tap [Fit Curve] to perform curve fitting on the time-intensity curve, where color of
the fitted curve is consistent with color of the current ROI curve.
The system can calculate characteristic parameters according to curve fitting formula and data,
display fit curve for time-intensity curve, and perform data analysis on time-intensity curve for
data table.
– Tap [Raw Curve] to hide/display raw curve.
– Tap [Table Display] to check parameters:

Item Description
GOF (Goodness of Fit) Calculate the fit degree of the curve; range: 0-1, where 1 means
the fit curve fits the raw curve perfectly.
BI (Base Intensity) Basic intensity of no contrast agent perfusion status.
AT (Arrival Time) Time point where contrast intensity appears, generally, the actual
time value is 110% higher than the base intensity.
TTP (Time To Peak) Time when the contrast intensity reaches peak value.

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 9 Contrast Imaging

Item Description
PI (Peak Intensity) Contrast peak intensity.
AS (Ascending Slope) Ascending slope of contrast, the slope between the start point of
lesion perfusion to the peak.
DT/2 Time when the intensity is half the value of the peak intensity.
DS (Descending Slope) Descending slope of the curve.
AUC (Area Under Curve) To calculate the area under the time-intensity curves during
contrast.

You can set range for the fit curve. After the range is set, the system displays fit curve within
the range only. Use the trackball/trackpad to the time-intensity curve to move the frame marker
position.
a. Set starting point of the fit curve: Use the trackball/trackpad to select the starting time and
tap [Set Fit Start].
b. Set end of the fit curve: Use the trackball/trackpad to select the end time and tap [Set Fit
End].
7. Use [X Scale] on the touch screen to choose different value, so that the X scale display manner
will be changed.
This function can be used to track detailed tissue information.
8. Save the curved image, export the data and do parameter analysis.
a. Tap [Export] on the touch screen.
b. Select the drive and enter the file name in the displayed window.
c. Select [OK] to save the data and return to the QA Analysis screen.
All displayed ROI traces are saved in the exported file.
The parameters are included in the trace file if the user has fixed a ROI.
After the exporting is succeeded, a .BMP format image is displayed in the thumbnail area
of the screen.
Only data from the user selected image range is included in the exported trace file.
9. Tap [Exit] to exit Contrast QA.

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10 Physiological Unit Signal

The physiological unit signal waveform is used for checking ultrasound image in ultrasound exam
(cardiac exam mainly).

WARNING
• Do not use the physiological traces for diagnosis and monitoring.
• To avoid electric shock, the following checks shall be performed prior to an
operation:
– The ECG electrode cable must not be cracked, frayed or show any
signs of damage or strain.
– The ECG electrode cable must be correctly connected.
– You must use the ECG leads provided with the physiological unit
module. Failure to do so may result in electric shock.
• The ECG electrode cable must be connected to the system first. Only after
the cable is connected to the system, can the patient be connected to the
ECG electrodes. Failure to follow these instructions may subject the patient
to electric shock.
• Do not place the ECG electrodes directly in contact the patient’s heart;
otherwise it may lead to stop of the patient’s heartbeat.
• Do not use this system when any digital device such as a high-frequency
electrotome, high-frequency therapeutic device or defibrillator is applied
already.
• Conductive parts of electrodes and associated connectors for ECG should
not contact other conductive parts including earth/grounding.
• Frequent trampling or squeezing on the cables may result in cable break-
down or fracture.
• Display effect of respiratory curve depends on the patient breathing status.
While a very slow or smooth breathing may lead to an inapparent
respiratory curve, breathing in a large amplitude may cause an incomplete
display of the respiratory curve. Display effect is linked to the connected
parts of the body. Generally, signals by connecting to limbs are stronger
than by connecting to the chest.

10.1 ECG
Perform the following procedure:
1. Connect the device and place ECG electrodes.
a. Turn off the power supply of the system, and connect the ECG module to the system.

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 10 Physiological Unit Signal

b. Connect the ECG cable to the ECG module.

c. Turn on the power supply of the system.
d. Place the ECG electrodes on the patient’s body (as shown in the following figure).

2. Tap [Physio] or press the user-defined key for “Physio” to enter physio operation interface.
3. Switch the imaging modes and display formats, adjusting the parameters to get an optimized
image.
4. Parameter adjusting:
Tap [ECG] on the touch screen to enable or disable ECG waveform curve. Adjust the [Speed],
[ECG Gain], [Position] and [Invert].
5. Trigger:
Select the trigger mode, or tap [Real & Trig] to set the trigger time, triggering delay time and
image display format.
6. Freeze the triggering image and the curve, and then review them.
7. Tap [Physio] or press the user-defined key for “Physio” to exit ECG mode, and remove ECG
electrodes from the patient.

ECG Triggering
ECG triggering means that image scanning is activated at some time points of ECG signals, thus
obtaining B images at these time points. The triggering image should be in 2D-mode.
When ECG triggering occurs, some marks (frame triggering mark) appear on the ECG waveform
(relative R wave, the time for delay set), indicating the time points when the 2D images are
captured.

TIP:
• The triggering mark is displayed in both freeze mode and live mode
• The marks in Dual trigger are in different colors.
• Triggering function is unavailable if the ECG trace is disappeared. Only the live 2D image can
be triggered.
• No delay time or time interval shall be less than the time required to scan a single image.
• If the delay time is longer than a heart cycle, then the heart cycle in the delay time is omitted,
that is to say no trigger is occurred when R waveform is detected in the duration.

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 10 Physiological Unit Signal

Triggering Mode
There are three triggering modes available: Single, Dual, and Timer.
• Single Trigger: When an R waveform is detected, an image will be triggered after delay time
T1. The time of T1 can be edited in single mode.
• Dual trigger: when an R waveform is detected, two images in two windows will be triggered
respectively after delay time T1 and T2. The time of T1 and T2 can be edited in dual mode.
• Timer Trigger: an image will be triggered after a time interval.The time interval can be edited
in triggering status.
The image triggering operation is described as follows (Take single trigger as an example):
1. Select exam mode.
2. Tap [Trig Mode] on the touch screen to enable the trigger.
3. Select [Single].
4. Set the delay time (or use the T1 by default).

Real & Trigger

Tap [Real & Trigger] to enable or disable the real trigger function.
After the [Real & Trigger] is enabled, two images are displayed respectively in two windows. One
is triggered by ECG, and the other is non-triggered real time image.

10.2 Respiratory Wave

Perform the following procedure:
1. Connect the ECG lead and position the ECG electrodes.
2. Tap [Physio] or press the user-defined key for “Physio” to enter Physio screen.
3. Switch the imaging modes and display formats, adjusting the parameters to get an optimized
image.
4. Parameter adjusting:
a. Tap [RESP] on the touch screen.
b. Adjust [Speed], [RESP Gain], [Position] and [Invert].
5. Exit Respiratory display mode, and remove ECG electrodes from the patient.
6. Tap [Physio] or press the user-defined key for “Physio” to exit physio mode.

10.3 ECG Review

10.3.1 Review Principle
When an image is frozen, the ECG waveform where the image is triggered will be frozen at the
same time. In the Dual triggering mode, the two window images are frozen at the same time.When
images are reviewed with the ECG electrodes connected, the ECG trace is the reference for time.
After the images are frozen, all real time images are in the status of linked review.

10.3.2 Linked Review of Waveforms, M/D Images and 2D

Images
If the physio unit signal, time curve and 2D image are frozen at the same time, the replay of them is
displayed at the same time.

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 10 Physiological Unit Signal

10.4 Parameter Description

The physio parameters are described as follows:

Parameter Description
ECG Source Select ECG source.
Gain Set the amplitude of the trace.
Position Set the vertical position of the both traces on the image display.
Speed Change the speed of the physio trace.
T1 Set the delay time T1 in Single trigger or Dual trigger.
T2 Set the delay time T2.
Interval Set the time interval for Timer.
Invert Invert the display.

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11 Stress Echo

Stress Echo is an option, only the phased probes support stress echo function under the cardiac
mode.

CAUTION
Stress echo data are provided for reference only, not for confirming diagnoses.

The Stress Echo feature allows you to capture and review cardiac loops for multiple-phase
(multiple-stage) Stress Echo protocols.
Stress Echo data consists of Stress Echo loops, wall motion scores, and all other information
pertaining to the Stress Echo portion of a patient examination.
A loop is a clip that displays the motion of an entire heart cycle, or from the beginning systole to the
end systole, as indicated by the R-wave of the ECG trace and determined by the QT – Time Table.
The loops in a given protocol are acquired by stages (phases), according to stage configuration
(continuous (prospective) or retrospective (non-continuous)).
• Loops in non-continuous stages are limited to a specified loop-per-view maximum (such as
four). View labels can only be selected in the configured order. Acquisition is retrospective -
when you press <Save> on the control panel, the system saves the previously acquired images.
• Loops in continuous stages are limited by time rather than a maximum number of loops - the
system stops acquisition after two minutes. Acquisition is prospective - when you select the
stage label and then press <Save> on the control panel, the system starts saving newly acquired
images. In some protocols, the system will jump to Select Mode after retrospective saving.
When images are saved, the system places a green checkmark to the right of the view or continuous
stage and then shifts the red mark to the next view or next stage.

11.1 Stress Echo Acquisition Procedure

To acquire Stress Echo loops, you must enable the ECG function.
Perform the following procedure:
1. Use the proper probe and cardiac-related exam mode, tap [Stress Echo] or press the user-
defined key for “Stress Echo” to enter stress echo imaging.
The system displays the “Select Protocol” window with the protocol selections.
2. Select the desired protocol and then tap [OK].
The system displays the real-time imaging screen.
– If the Stress Echo manual ROI option is selected in the Maintenance dialog box, the
system also displays a region of interest (ROI).
– If Acquire Mode is set as Full-screen in Maintenance, then no ROI box is displayed.
3. According to the help information in the bottom of the screen, if an ROI is displayed, adjust
the ROI size and position. Press <Update> on the control panel to confirm the ROI.

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 11 Stress Echo

When you confirm the ROI size by pressing <Update>, you cannot adjust the ROI size during
acquisition. You can only adjust the ROI position using the trackball/trackpad.
4. Press <Save> on the control panel to start acquisition.
The system displays the Protocol window on the screen, listing the phases for the selected
protocol along with the first phase views (phases are stages). The system selects the first view
for acquisition by default.
5. Proceed through each view in each stage according to the following instructions:
Non-continuous stages:
– To save acquired images for the selected view, press <Save> on the control panel. The
system goes to the next view for acquisition by default, saved views are marked with a
green “√.”
– Use [Stages XXX] or [Views XXX] to select the stage and view for image acquisition (or
reacquisition). Press <Save> to start acquisition.
Views can be re-acquired until you tap [End Acquisition].
If the protocol contains continuous stages (for alternative workflows), then proceed through
each continuous stage according to the following instructions:
– To begin saving acquired images for the selected stage, press <Save> on the control panel.
– The system displays a percentage marker below the selected stage indicating the progress
of the continuous capture.
– To halt saving acquired images for the selected stage, tap [Pause] on the touch screen or
press <Freeze> directly. The percentage stops increasing.
– Select [Continue] or press <Freeze> again to continue.
– To end the current acquisition, press <Save> on the control panel.
– To select another continuous stage, use [Stages XXX] on the touch screen.
– Suspending is not allowed under continuous exam.
When acquisition is complete for each stage, the system advances to the next stage. If the stage
is non-continuous, the system displays the stage views. When image acquisition is completed
for all views and continuous stages, the system switch to Select Mode.
6. To start or restart the timer, tap [Stage Timer]/[Exam Timer] to turn it on.
The Stage time is displayed to the right side of each stage in the protocol list, while the Exam
time is displayed in the left side of the screen.
Each saved image will be marked with two times T1 and T2. T1 refers to the total time of the
whole acquisition, while T2 indicates the time the acquisition lasted for a certain stage.
7. To review loops before ending acquisition, select [Review/WMS]. You can redisplay the real-
time imaging screen to continue acquisition by selecting [Acquire].
8. To end the acquisition and review the acquired images, tap [End Acquisition].
When the acquisition is ended, no stress echo image acquisition can be performed for the same
exam.

11.2 Selecting Preferred Stress Echo Loops (Select

Mode)
The selected clips are used for analysis in the review mode and wall motion scoring mode. Select
Mode is used to select the best loops of the examination.

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When the acquisition is ended, select mode is enabled automatically.

In Select Mode, you can select the representative loop (“preferred” loop) for each view.
To select “preferred” loops:
1. Use the <Update> key according to tips in the trackball/trackpad hint area or select [Select] to
enter the Select Mode, or the system enters the Select Mode directly after the acquisition is
finished.
2. Select the loop. Use the buttons displayed during Select Mode to designate another loop or
another view for display.
– Use [Stages XXX] or [Views XXX] to select the target stage/view.
– Single-click a clip to select the clip for current stage/view and zoom in the clip to the full-
screen.
– Double-click a clip. The clip will be magnified.
– Tap [First/Last] or [Previous/Next] on the touch screen to display another loop in the
current view.
3. Select the stage and view to display all loops for the view and then continue designating the
“preferred” loop for each displayed view until all views are completed.
Description of select mode controls:

Selection Description
Stages XXX To select a stage.
Views XXX To select a view.
Acquire/Select/ Review/ To switch the mode status.
WMS
1. Clip/2. Clip/3. Clip/4. For selecting views in the selected stage.
Clip
Next Next four Clips.
Previous Previous four Clips.
First Go to “first” Clips.
Last Go to “last” Clips.
Play Click to play/stop cine play.
Prev frame See previous frame of the cine file.
Next frame See next frame of the cine file.
First frame See first frame of the cine file.
Last frame See last frame of the cine file.
Speed decrease/Speed Decreases or increases playback speed.
increase
Text Function that turns the screen graphic text “On” or “Off”. Information
includes: name of level, name of view, heart rate, time stamp
acquisition, timers, frame slider, loop ID, clip control. For the cine
without distributed view, the name of level and name of view are
displayed in “--”.
Apply edit all Clip edit applied to all clips taken.
Clip Length Specify the clip segments: systole, diastole, full cycle or user-defined.

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Selection Description
Bookmark For continuous acquisition, when the bookmark is set to “On”, only the
selected loops for the current view can be displayed.
Delete Unselected Delete clips that are not selected. If selected, the system will delete all
clips that are not selected after the exam is ended.
Suspend exam Pauses the stress echo exam but does not end the stress echo exam.
When a stress echo exam is suspended, the user can perform image
acquisition of all other imaging modes, or perform operations such as
measurement.
End SE exam End the stress echo exam.

11.3 Review/WMS Mode

Review/WMS mode is used by cardiologists to evaluate clips for cardiac wall motion
abnormalities. Different views from different stages are selected for comparison across a wide
variety of combinations. The most common workflow is to compare “same views” but at “different
stages” of the exam (e.g., PSLA view, Rest stage compared to PSLA view, Post-exercise stage).

11.3.1 Enter review mode

Select [Review/WMS] to enter review mode, and then select the label of the phase or view (for
example, Rest or Long Axis), the system displays all loops that represent the selected phase or
view.

To display phases for the selected view(s)

Perform the following procedure:
1. To include a phase or view for display, select the leftmost, gray box to the left of each required
phase and/or view.
The system inserts a checkmark into each selected gray box.
2. To exclude a phase or view from display, select the blue box to the left of each required phase
and/or view.
The system inserts a X into each selected box, like .
3. Select [Display Selected] on the touch screen.
The system displays the selected phases for each selected view side by side.

To display all views for a specific phase

Select the phase label (for example, Rest).

To display all phases for a specific view

Select the view label (for example, PLAX).
The system displays all phases for the selected view.

To display a loop in full-screen format

1. Double-click the loop to display in full-screen format.
2. Double-click the loop again to display the loop in its initial size, select the loop again.

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Description of review/WMS mode keys (keys with the same function as in select mode are not
described below):

Item Description
Review/WMS Perform side-by-side comparison of the same views at different stages
(PLAX, PSAX, A4C, A2C at “Rest” compared to PLAX, PSAX, A4C,
A2C “Post-Exercise”). Clips are synchronized.
• Under [Text] “Off” status, when you select one stage, all view loops
are displayed on the screen; when you select one view, all loops of
the same view in different stages will be displayed on the screen.
• Set [Text] to “On”, the system will select loops of first two views of
the first two stages to display automatically. If you choose
[Previous], then loops of the next two views of the first stages will
be displayed. If you choose [Next], loops of the first two views in
the 3rd and 4th stage will be displayed.
In the meantime, if you choose one stage, loops of all views under this
stage will be displayed on the screen (4 at most), and choosing one
view will lead to loops of this view in different stages be displayed (4 at
most).
Display Selected Displays loops of all the stages and views selected.

11.3.2 Wall Motion Scoring

The WMS-Report lists user-assigned wall motion scores and associated data.
The Wall Motion Score (WMS) measurement is an application prepared for assisting in stress echo
semi-quantitative evaluations of abnormalities with left ventricular wall motion or changes in wall
thickness. The left ventricle is divided into segments for scoring to evaluate the degree of
abnormality from the sum of the scores in each segment using the motion of the walls of the entire
left ventricle.
You can assign wall motion scores to specific portions within each view (representative loop). You
can also assign a normal wall motion score (WMS) to the currently selected view or to all displayed
views.
Two methods of chamber segment division, ASE 16 and ASE 17, are supported. In addition, each
segment has 3 kinds of scoring method: 4, 5 and 7 points. Select through the [Scoring] control on
the touch screen.
To assign a wall motion score (WMS):
1. Select a colored number.
The meanings and colors used in segments are listed in the table below.

Score Meaning Color

1 Normal Green
2 Hypokinesis Yellow
2.5 Severe Hypokinesis Khaki
3 Akinesis Blue
4 Dyskinesis Red
5 Aneurysm Purple

2. Use the trackball/trackpad to select the value and then click the target segments, then the
segment is assigned with a value.

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 11 Stress Echo

3. Repeat step 2 to perform value assign for all segments.

– To assign a normal wall motion score (WMS) to all currently displayed views:
Select [Set All Normal] on the touch screen.
– To assign a normal wall motion score (WMS) to the currently selected view:
Select [Set Current Normal] on the touch screen.

11.4 Saving Stress Echo Data

Stress Echo data consists of Stress Echo loops, wall motion scores, and all other information
pertaining to the Stress Echo portion of a patient examination.
When the exam is ended, the system will save all images within the exam.

11.5 Exiting the Stress Echo Feature

To exit the Stress Echo feature:
Tap [End SE exam] on the touch screen.

11.6 Measurement and Report

Suspend the stress echo exam by selecting [Suspend Exam]. Press the measurement related keys or
buttons to enter cardiology measurement. For details, see the Advanced Volume.
Reports contain the entered indication, if any, and also any entered comments that are specific to
the report. You can include or exclude data from specific phase(s). You can preview and print the
report for the currently selected mode. You can also enable colored report printing in Maintenance.
You can enter indications or comments for display in Stress Echo reports.
To enter an indication:
1. Tap <Report> to open the report.
2. Use the soft keyboard to enter text in the Indication dialog box and then tap [OK].

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12 Display & Cine Review

12.1 Splitting Display

The system supports dual-split and quad-split display format. However, only one window is active.
The multi-window display can complete the image and multi-frame image comparison.

Dual-split
Press <Dual> on the control panel to enter the dual-split mode, and use <Dual> / <Update> key to
switch between the two images; press <B> to exit.

Quad-split
Press the user-defined key for “Quad” to enter the quad-split mode, and use the user-defined key to
switch among four images; press <B> to exit.
Modes support quad-split display: B mode, Color mode and Power mode.

12.2 Image Magnification

NOTE:
Zooming an image changes the frame rate which tends to change thermal indices. The position of
the focal zones may also change which may cause the peak intensity to occur at a different location
in the acoustic filed.As a result, the MI may change.

12.2.1 Spot Zoom

Perform the following procedure:
1. Press <Zoom> to enter the sample volume definition status.
2. Use the trackball/trackpad to change the box size and position. Press <Set> to toggle between
setting the size and position.
3. After the sample volume is set, press <Zoom> / <Update> again to enter spot zoom status.
4. Use [Zoom Value] to change the magnification factor.
The image magnification factor value will display in real time in the image parameter area.
5. The size and position of sample volume box change along with scan depth and area.
6. Press <Zoom> again to exit spot zoom.

12.2.2 Pan Zoom

Perform the following procedure:
1. Use [Zoom Value] on the touch screen to enter the pan zoom status.
2. Adjust the Zoom value, Image-in-image is displayed.
The image magnification factor value will display in real time in the image parameter area. For
example, “Z 1.40” indicates that the magnification factor is 1.4.

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3. Use the trackball/trackpad to shifting the image.

4. Adjust the magnification factor to 1.00 to exit pan zoom.

12.2.3 iZoom (Full-screen Zooming)

Perform the following procedure:
1. Press the user-defined key for “iZoom” to zoom in the image.
The zooming area includes image area, parameter area, image banner, and so on.
2. Press the user-defined key again to zoom in the image area only.
The image goes to full-screen.
3. Press the user-defined key again to exit.

12.3 Freeze/Unfreeze the Image.

Press [Freeze] key on the control panel to freeze a scanning image. In freezing mode, the probe
stops transmitting acoustic power, and all images as well as the parameters are kept still.
After freezing an image, the system may enter cine review, measure, comment adding, or body
mark mode, which is dependent upon preset, see “4.1.2 General”.
Press <Freeze> in frozen mode to unfreeze the image, and the system continues image scanning.

12.3.1 Imaging Mode Switching When Frozen

Imaging mode switching in frozen mode follows the following principles:
• In splitting display B mode, press <Dual>/user-defined key for “Quad” to switch among the
windows; press <B> to exit splitting display mode and enter the image of the currently
activated window in full screen.
• In frozen mode, the system supports imaging mode switching between the sub-modes (only for
the activated window). For example, if the frozen image is of B+C+PW mode, then the system
supports imaging mode switching between B+C+PW, B+C, B+PW and B by pressing <C> or
<PW>.
• The imaging mode and parameters of an unfrozen image is the same as the corresponding one
that before frozen; but the display format is the same as the one before unfrozen.

12.4 Cine Review

The system allows you to review and edit the images prior to the image frozen. This function is
called as cine review. The magnified images can also be reviewed, and the operating method is the
same. You can perform zoom, measurements, add comments and body marks on the images being
reviewed.
The system supports manual review as well as automatic review. The default setup is Manual Cine,
but you can switch between Auto Cine and Manual Cine.
In addition, the system supports the images reviewed along with physiological unit waveforms, if
the detection of physiological unit waveforms is performed.

CAUTION
• The cine memory must be cleared at the end of the current patient and the
onset of the next new patient by tapping [End].

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• Cine files stored in the system’s hard drive shall contain patient information,
to avoid the selection of an incorrect image file and potential misdiagnosis.

12.4.1 Entering/Exiting Cine Review

To Enter Cine Review
• The system enters the manual cine review status once press <Freeze> to freeze the image.
• Open cine files in thumbnail, iStation or Review. The system enters automatic cine review
status.

To Exit Cine Review

Press <Freeze> or <B>, the system will return to image scanning and exit cine review.

12.4.2 2D Cine Review

Manual Cine Review
Enter the cine mode in 2D imaging mode. Use the trackball/trackpad to view the cine.
• If you move the playback mark to the left by using the trackball/trackpad, the review sequence
is reversed to the image-storing sequence, thus the images are displayed in descending order.
Whereas, if you move the playback mark to the right by using the trackball/trackpad, the
review sequence is the same as the image-storing sequence, thus the images are displayed in
ascending order. When you review images until the first or the last frame, further using the
trackball/trackpad will display the last or first frame.
• The review speed is adjusted through the trackball/trackpad.
The cine progress bar at the bottom of the screen (as shown in the figure below):

1 2 3 4 5

1 Start mark
2 Playback mark
3 End mark
4 Current frame
5 Total frames
6 Auto Review Region

Reviewing all of Auto Review

Perform the following procedure:
1. In the manual cine review status, use the [Auto Play] to set the review speed to activate auto
cine review.
2. Exit:

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Tap [Auto Play] on the touch screen, or use the trackball/trackpad, the auto review state
becomes manual cine review.

Setting scope of Auto Review

You can set a segment of cine loop which can be reviewed automatically.After the auto review
scope is set, the auto cine review can only be performed within this scope; but the manual cine
review can be performed beyond this scope. When the cine file is saved, only the images within this
scope are saved.

TIP:
You can perform cine review on each image window in the dual/quad splitting mode, and set auto
review region for each window.

Perform the following procedure:

1. Set the start frame:
Manually review the cine file by trackball/trackpad, and tap [Set Begin] on the touch screen to
set current frame to be the start point.
2. Set the end frame:
Manually review the cine file by trackball/trackpad, and tap [Set End] on the touch screen to
set current frame to be end.
3. Use [Auto Play] on the touch screen to set the review speed.
The system plays the auto review region automatically.
4. Tap [Jump to First]/ [Jump to Last] to review the first or last image.

12.4.3 Cine Review in M/PW/CW/TVD Mode

Enter cine review in M mode, PW mode, CW mode TVD mode, and then use the trackball/trackpad
the cine images are displayed on the screen one by one.
Move the playback mark to the left by using the trackball/trackpad. The review progress slider
moves to the left, the images moves to the right, and the earlier stored images are invoked. Whereas
move the playback mark to the right by using the trackball/trackpad, the review progress slider
moves to the right, and the images move to the left, the recently stored images are invoked. When
the image goes to the first/last frame, the cine is played in loop with the trackball/trackpad moving
left or right.
The cine progress bar at the bottom of the screen (as shown in the figure below):
6

1 2 3 4 5

1 Start mark
2 Playback mark
3 End mark
4 Time played
5 Total time

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6 Auto Review Region

Cine review operations are the same as these of 2D mode.

TIP:
There is no audio when the spectrum is reviewed in manual status but audio synchronization can be
realized in auto review status with speed of ×1.

12.4.4 Linked Cine Review

The linked cine review refers to review of the images captured at the same moment.
• B/Color/Power/TVI/TEI dual live
• B/B dual live
• B+M synchronization mode
• B+PW/TVD duplex mode
• TVM, CM triplex mode

1 Frame synchronization mark

2 Playback progress bar

The frame synchronization mark on the time mark of M/PW image indicates the corresponding 2D
image and M/PW image. In statuses other than dual live status, you can only review images in the
currently active window.

12.5 Image Compare

12.5.1 Image Compare in Review Mode
TIP:
For B/B+COLOR/B+TVI/B+POWER/B+TEI mode image, you can select at most 4 images; for
PW/M/CW/TVD mode image, you can select at most 2 images

Perform the following procedure:

1. Tap [Compare] on iStation screen or Review screen.
2. Select the images for comparison.
Click to select the image, and the icon appears on the image, which indicates the image is
to be compared.
If select the wrong image, click the image again to cancel the selection.
– Select image size display on “Thumbnail Size” bar to display more images at a time.

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 12 Display & Cine Review

– Image compare of different exams for the same patient: Select “all” in the drop-down list
of “Exam History” to see all exam files, then you can select different images of different
exams to compare.
3. Repeat the step 2 above to add the image to be compared.
There is “Display” column you can filter the images by selecting “All Items”, “Selected”,
“Unselected”.
Click [Clear Selected] to clear all selected images.
4. Click [OK] to enter image comparison.
5. Switch the multi-frame cine among the windows to review (single-frame image cannot be
reviewed).
– Press <Dual> to toggle between the two images.
– Press the user-defined key for “Quad” to switch among 3-4 images.
The window with the highlighted “M” mark is the current activated window.
You can select the image to be reviewed at synchronous time when the multi-frame image is
reviewed by using [Sync Play].
6. Save the image if necessary.
7. Click [Return] on the screen or press <Freeze> to exit image compare.

12.5.2 Frame Compare

TIP:
Cine compare can only be performed for B/C mode image only. The image on dual/quad window
cannot be compared.

Perform the following procedure:

1. Freeze the image in B/C mode, tap [Frame Compare] in “Cine” page on the touch screen to
enter frame comparison mode.
2. Review the images of different image windows (cine replaying can’t be performed for single-
frame image file), press <Update> or <Dual> key to switch the active image window.
3. Save the image if it is necessary.
Measurements, adding comments and body marks are allowed.
4. Tap [Frame Compare] again to return to image frozen status; press <Freeze> to enter real-time
imaging.

12.6 Cine Saving

12.6.1 Live Capture
Live capture refers to saving the images or cines in image scanning status; after the storage, the
system continues image scanning.
Live capture can be divided into 2 kinds: retrospective and prospective.
• Retrospective saving is to save the specified images before the current moment; to save the
images stored in the cine memory to the system hard disk.
• Prospective saving is to save the specified images later than the current moment; to save the
images to both the cine memory and the system hard disk.

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The live capture time can be set in “Cine” page on the touch screen.
In imaging mode, tap [Pro Capture] / [Retro Capture] on the touch screen or press the user-defined
key for “Save Cine (Prospective)/(Retrospective)” on the control panel.

TIP:
• Press the save key again or <Freeze> to stop saving.
• When a saving is completed, a thumbnail is showed in the Thumbnail area.

12.6.2 Frozen image storage

In frozen mode, tap [Pro Capture] / [Retro Capture] on the touch screen or press the user-defined
key (The key has already been assigned the function as “Save Clip retrospective or prospective”).
After the cine is successfully saved, there is a thumbnail displayed on the screen.

12.7 Setting Cine Length

NOTE:
The system ends up saving if the cine length goes beyond the maximum value.

12.7.1 Live capture

Prospective Cine Length
Prospective cine duration: set the time that the user taps [Prospective] as the start time. The system
proceeds saving the cine.
• With the ECG disabled: tap [Cine] tab, and use [Time (Pro)] to adjust it.
• With the ECG enabled: tap [Cine] tab. Tap [Saving type (Post)] to choose the type of the
saving time and the cardiac cycles. Use [Time (Post)] or [Cycle (Post)] to adjust it.

Retrospective Cine Length

Retrospective cine duration: set the time that user taps [Retro] when playing the first frame of the
image. It also refers to saving the cine or cycles retrospectively.
• With the ECG disabled: tap [Cine] tab, and use [Time (Retro)] to adjust it.
• With the ECG enabled: tap [Cine] tab. Tap [Saving type (Retro)] to choose the type of the
saving time and the cardiac cycles. Use [Time (Retro)] or [Cycle (Retro)] to adjust it.

12.7.2 Freeze storage setting

The first frame of the image starts when the user presses <Freeze> at the first time. The system
saves the cine in the auto review scope retrospectively.
Press <Freeze> to freeze the image. Use [Time (Retro)] to set the cine time of retrospective saving
in frozen status under Cine page, or mark the start frame in the auto review scope to set the cine
time of retrospective saving in frozen status.

TIP:
It is only available to save the cine retrospectively in the frozen status.

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13 Measurement, Comments and
Body Mark

13.1 Measurement
There are general measurements and application measurement. You can perform measurements on
a zoomed image, cine reviewing image, real-time image, or frozen image. For measurement details,
please refer to the Advanced Volume.

WARNING
• Be sure to measure areas of interest from the most optimal image plane to
avoid misdiagnosis from inaccurate measurement values.
• To obtain accurate Doppler flow measurement values, make sure the
transmitting beam is not perpendicular to the flow, otherwise false readings
and potential misdiagnosis may result.

CAUTION
• If an image is unfrozen or the mode is changed during a measurement, the
calipers and measurement data will be cleared from the screen, but the
measurement data will be stored in the report.
• If the system is turned off or [End] is selected during a measurement, the
data not saved will be lost.
• In Dual-B imaging mode, the measurement results of the merged image
may be inaccurate. Therefore, the results are provided for reference only,
not for confirming a diagnosis.

Measurement Accuracy

Table 13-1 Error of 2D Images

Parameter Value Range Error
Distance Full screen Within ±3%
Area Full screen Within ±7%
Circ Full screen Within ±10%
Angle Full screen Within ±3%
Volume Full screen Within ±10%

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 13 Measurement, Comments and Body Mark

Table 13-1 Error of 2D Images

Parameter Value Range Error
Distance (iScape) Full screen Within ±5% (for linear, wide-
convex, and phased probes)
Full screen Within ±10% (for micro-
convex probes)

Table 13-2 Time/Motion Measurements

Parameter Value Range Error
Distance Full screen Within ±3%
Time Timeline Display Within ±2%
Heart rate Timeline Display Within ±4%
Velocity (PW mode) 10-200 cm/s (for non- When angle ≤ 60°, ≤5%
transcranial application)
10-300 cm/s (for transcranial Within ±20%
application)
Velocity (CW mode) 10-200 cm/s (for non- When angle ≤ 60°, ≤5%
transcranial application)
10-300 cm/s (for transcranial Within ±20%
application)

Table 13-3
Function Measurement item Error
Smart IVC Dmax Within ±10%
Dmin Within ±10%
CI Within ±10%
DI Within ±10%
IVCV Within ±10%
Smart VTI LVOT Vmax Within ±10%
LVOT VTI Within ±10%
LVOT HR Within ±10%
LVOT SV Within ±10%
LVOT CO Within ±10%
Smart B-line Percent Within ±10%
Dist Within ±10%
Avg Dist Within ±10%
B lines 0
Smart FHR OB1 / Within ±10%

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Table 13-3
Function Measurement item Error
Auto GA / Within ±10%
Smart Bladder / Within ±10%
Auto DFR / Within ±20%

NOTE:

Within the selected field range, the measurement accuracy is ensured within the range mentioned
above. The accuracy specifications are performance in the worst conditions, or based on the real
test for the system, regardless of acoustic speed error.

13.2 Comments
Comments can be added to an ultrasound image to bring attention, notate or communicate
information observed during the examination. You can add comments to: zoomed image, cine
review image, real-time image, frozen image. You can type the character as comments; insert the
pre-defined comments from the comment library; insert arrow markers or add the trace.
For products equipped with the trackpad, set user-defined keys for comments (text, arrow and trace)
first, see “4.1.7 Key Configuration”.

WARNING
You must ensure that the entered comments are correct. Incorrect comments
may lead to misdiagnosis.

13.2.1 Adding Comments

Adding an Comments Text
Perform the following procedure:
1. Select <ABC> button > [Comments] tab or press the user-defined key for “Annotation” to
enter the comment status.
2. Use the trackball/trackpad or press direction-control keys on the soft keyboard to move the
cursor to the desired location for comments.
3. Do one of the following to add a comment:
– Tap the desired comment text on the touch screen, the system adds the selected comment
text onto the screen where the cursor is anchored, you can edit the comment directly.
– Type the alphanumeric characters through the soft keyboard.
In the edit status, tap [Enter] to move the cursor to the new line, and the location of the cursor
is aligned with that of the first line
4. In comments edit status, press <Set> or <Enter> key, or move the cursor to confirm the added
comments text and exit the edit status.

Adding an Arrow
You can add an arrow to a location where you want to pay attention.
Perform the following procedure:

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1. Select <ABC> button > [Comments] > Arrow button or press the user-defined key for
“Arrow” to enter the arrow status.
2. Adjust the position and orientation of the arrow:
– Use the trackball/trackpad to move the arrow to the desired position.
– Rotate the <Angle> knob to change the arrow’s orientation.
If needed, tap [Advanced Settings] to enter comment property screen to set the arrow style/
size.
3. Press <Set> to anchor the arrow position.
Repeat steps above to add more arrows if necessary.
4. Press <ABC> or the user-defined key for “Arrow” to exit the arrow comment status.

Trace
In comment status, tap [Advanced Settings] > [Trace] on the touch screen to activate trace function,
and the current image is also displayed on the touch screen.
Using the control panel:
1. Use the trackball/trackpad to move the cursor to a desired position, and press <Set> to confirm
the start point.
2. Use the trackball/trackpad to move the cursor along the edge of the desired region and trace the
outline of the region.
– Rotate the <Angle> knob counter-clockwise to cancel 1 pixel of trace.
– Rotate the <Angle> knob clockwise to restore 1 pixel of trace.
– Short press <Clear> to clear last trace. Long press <Clear> to delete all tracing.
3. Press <Set> to finish the tracing.
Using the touch screen:
1. Trace around the ROI by taping the touch screen image using your finger.
2. Remove your finger to finish the tracing.
– [Clear]: tap to delete the trace in reverse order one by one.
– [Clear All]: tap to delete all traces.
3. Tap [Exit] to exit the tracing.

13.2.2 Moving Comments

TIP:
If image size and position changed due to display format switching, then the position of the
comment can be changed, too.

Perform the following procedure:

1. Select the comment to be moved.
2. Use the trackball/trackpad to move the comment to the new position.
3. Press <Set> key to anchor the comment in the new position, and the comment-moving
operation is complete.

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13.2.3 Editing Comments

Modifying characters
Perform the following procedure:
1. In comment status, move the cursor onto the comments to be modified.
Press alphabetic keys to enter the character to the cursor position directly.
Or, double press <Set> to enter comment editing status, and use the direction-control keys to
move the cursor to the desired location to insert/delete characters; you can either type
characters by pressing the corresponding keys or select the new comment text from the menu.
2. Press <Del> to delete the comment character or text on the right side of the cursor; press
<Back> to delete the comment character or text on the left side of the cursor.
3. Press <Set> key, or move the cursor to confirm the added comments text and exit the edit
status.
If there are already comments on the screen, press the space bar to enter editing status.

Modifying Arrows
Perform the following procedure:
1. Move the cursor on the arrow that needs to be modified. After the cursor becomes , press
<Set>. There is a frame around the arrow, indicating the arrow can be edited. Move the cursor
to change the arrow position.
2. Rotate the <Angle> knob to modify the arrow’s direction.
3. Press <Set> key to complete the operation.

13.2.4 Deleting Comments

Deleting Comments Characters, Texts or Arrows
Perform the following procedure:
1. Move the cursor to the comments to be deleted.
2. Press <Set> to select the comment.
3. Tap [Delete Word] or press <Clear> to complete the deletion.

Deleting a recently-added character, text or arrow

In comment status, press <Clear> to delete the latest added/modified comment unit.
Enter letters by pressing the alphanumeric key on the keyboard and use blank key to divide the
letters. Tap [Delete Word] to delete latest added/modified comment unit and enter comment status.

Delete letters one by one

In comment editing status, tap <Back> to delete letters before cursor “|”.
In comment editing status, tap <Del> to delete letters after cursor “|”.
In comment status, enter letters by pressing the alphanumeric key on the keyboard. Tap [Delete
Word] to delete letters before cursor “|”.

Erase All Text

NOTE:
• When no item is selected, press <Clear> will clear all comments and all measurements
calipers.

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• After powering off, the system will clear all comments on the image.

Long press <Clear> key to delete all the comments.

13.2.5 Setting the Start Position

Perform the following procedure:
1. Select <ABC> > [Comments] or press the user-defined key for “Annotation” to enter the
comment status.
2. Move the cursor to the target position, then press <Set Home> to set the start position of the
comment.
Tap <Home> on the touch screen; the cursor returns to the start position.

13.3 Body Mark

NOTE:
After powering off, the system will clear all comments on the image.

The Body Mark feature is used for indicating the exam position of the patient and transducer
position and orientation.
You can preset the system configured general body marks for each exam mode. The system
supports the import of user-defined body marks.
For products equipped with the trackpad, set user-defined keys for bodymark first, see “4.1.7 Key
Configuration”.

13.3.1 Adding Body Mark

Perform the following procedure:
1. Press or the user-defined key for “Body Mark” to enter the Body Mark status.
2. Tap the desired body mark on the touch screen directly.
3. To adjust the probe position and orientation marker:
– Use the trackball/trackpad to place the probe marker at the correct position.
– Rotate <Angle> to adjust the mark’s direction.
– Tap [Save Probe] to save the current direction and position for the probe mark of the
current body mark.
4. Press <Set> to confirm the position and orientation of the probe marker and exit the body mark
mode.

13.3.2 Moving Body Marks

You can move the body mark graphics to any desired position within the image area.

NOTE:
In Dual B Mode, a Body Mark cannot be moved between the separate image windows.

Perform the following procedure:

1. Press <Cursor> and move the cursor onto the body mark. The cursor then becomes ,
indicating you can move the Body Mark graphic to a new position.

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 13 Measurement, Comments and Body Mark

2. Press <Set> key to select the body mark.

3. Move the Body Mark graphic to the desired position.
4. Press <Set> key to anchor and confirm the new graphic position.

13.3.3 Deleting Body Marks

TIP:
• Preset returning, switching the exam mode/patient/probe will clear the body marks.
• Set if body mark is erased when the image is unfrozen, see “4.1.4 Application”.

Perform the following procedure:

1. Press <Cursor> and move the cursor onto the body mark. The cursor then becomes .
2. Press <Clear> to delete the body mark.

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14 Patient Data Management

An exam record consists of all information and data of one exam.

An exam record consists of the following information:
• Patient basic information and exam data
• Image files
• Report

NOTE:
• DO NOT use the internal hard drive for long-term image storage. Daily backup is
recommended. External storage media is recommended for archiving images.
• The system patient database space is limited, please back up or clear patient data in time.
• Mindray is not responsible for lost data if you DO NOT follow suggested backup procedures.

14.1 Image File Management

You can store the image files either in the patient database in the system, or to external memory
devices.For a save image, you can perform operations like image reviewing, analyzing and
demonstration.

14.1.1 Storage Media

System supported memory media including:
• System hard disk
• USB memory devices: USB flash drive, removable USB hard disk
• Optical disk.

14.1.2 Image File Formats

The system supports file formats which belong to the system and file formats which are PC-
compatible.

System-relevant formats
• Single-frame image file (FRM)
Refers to single-frame static image files not to be compressed; you can perform measurements
and comments adding on this type of files.
• Cine file (CIN)
System-defined multi-frame file format; you can perform manual or auto cine review, and
perform measurements or add comments for the reviewed images. After you open a stored CIN
file, the system automatically enters cine review status.

PC-compatible formats
• Screen file (BMP)

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 14 Patient Data Management

Single-frame file format, used to save the current screen, non-compressed format;
• JPG: Single frame export format.
• TIFF: Single frame export format
• Multi-medium files
Multi-frame export format.
• DICOM files
DICOM standard files format, single-frame or multi-frame format, used to record patient
information and images; you can only open DCM files to view rather than to edit.

14.1.3 Image Storage Setting

• Set the image size, see “4.1.3 Image Preset”.
• Set cine saving length, see “12.7 Setting Cine Length”.
• Set send/print image after end exam, see “4.1.2 General”.
• Set user-defined key and auxiliary output function, see “4.1.7 Key Configuration”.

14.1.4 Quickly Saving Images to the System

To save a single-frame image to the system quickly
Press the user-defined key for “Save Image” to save the image.
• The image format is FRM in the imaging interface.
• When a dialog box is displayed on the current screen, press the user-defined key to save the
screen in the BMP format.

To save cineloop image to the system quickly

Press the user-defined key for “Save Cine (Retrospective/Prospective)” to save the cine file in the
default file directory in the CIN format.
The thumbnail of this image will appear in the thumbnail area on the screen. When you move the
cursor onto the thumbnail, its file name with suffix will be displayed.

Quickly Saving Full Screen Image to the System

Press the user-defined key for “Full Screen” to save the image. The format of the image is PNG.
The full screen image is saved to the default path with the default name. The thumbnail of this
image will appear in the thumbnail area on the screen. When you move the cursor onto the
thumbnail, its file name with suffix will be displayed.

14.1.5 Saving Images to USB Flash Drive

Press the user-defined key for “Save Image to USB Disk” to save the image to the USB flash drive.

14.1.6 Exporting Cine File to USB Flash Drive

Use the user-defined key to export the cine to the USB flash drive (not saved to the local path).
The file is stored in the directory: X (USB flash drive name): patient name+ ID\exam type + exam
time \ image ID.
1. Perform the scan and freeze the image.
2. Press the user-defined key for “Send Cine to USB Disk” to save the images to the USB flash
drive.

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14.1.7 Auxiliary Output Function

For the following three functions, the system provides auxiliary output function setting: “Save
Image”, “Save Cine (Retrospective)” and “Save Cine (Prospective)”. When the corresponding user-
defined key is pressed, the ultrasound system can perform multiple operations one by one as per the
preset.
Taking “Save Image” as an example, add the auxiliary functions “Send Image to DICOM Storage”
and “Send Image to USB disk”, press the user-defined key, then the system will perform three
steps:
1. Save the image to the local hard disk.
2. Send image to DICOM Storage server.
3. Send the image to USB disk.

14.1.8 Thumbnails
The stored images or cineloops are displayed in the form of thumbnails on the screen:
• During image scanning, thumbnails of the current exam display in the Clip board/Thumbnails
Area of the screen.
• In the iStation screen, the thumbnails of the current selected patient display at the bottom of the
screen. When you move the cursor onto a thumbnail, its name and format will display.
• On the [Review] page, the thumbnails refer to the images stored in the same exam. When you
move the cursor onto a thumbnail, its name and format will display.
• On the Review page, open images to enter the image analyzing status, all the thumbnails
belong to the exam are displayed.

14.1.9 Image Review and Analysis

The system supports the image review and analysis to the saved patient image.

To review images
You can review all images stored in an exam, and send, delete or analyze the stored images.
• During image scan, saved image thumbnails will display on the right of the screen.
Move the cursor onto a thumbnail, and press <Set> twice to open the image. The [Review]
page display in the touchscreen to display the image file, double click the image in the
touchscreen to open the image; if the stored image is a cine file, double-click the thumbnail to
enter the auto cine review.
• To enter image review:
– Tap [Review] to enter review page. Images of the current exam and the current patient are
displayed.
– Select an exam of a patient in the iStation screen, and click <Review> or double-click the
exam to enter the Review screen to review the images of the patient.

Analysis
In the image analysis status, you can view, zoom, perform post processing and measurements, add
comments and perform cine review for a stored image (FRM or CIN format). The operation steps
are the same as those for real-time scanning; please refer to relevant sections for details.
1. To enter image analysis:
– In the image scanning or freeze status, double-click a thumbnail stored in this exam to
enter the image analysis status; or

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– In the image review status, double-click the selected thumbnail to open the image.
You can perform cine review operations in image analysis status.
2. To exit the image analysis:
– Press <Freeze> to exit and enter the real-time scan status.
– Press [Return] to exit from the image analysis to the Review status. In image analysis
status, the selected image is displayed on the screen, and the thumbnails of the same exam
are displayed on the thumbnail area, you can turn pages using the buttons on the right side
of the thumbnail.

14.1.10Sending Image File

NOTE:
Data saved this way can only be reviewed on the PC and cannot be restored to the ultrasound
system.

Perform the following procedure:

1. Do one of the following to bring up the “Send To” screen:
– In the main screen, select a stored image thumbnail and click on the upper right
corner of the image.
– In the iStation screen, select a stored image thumbnail and click on the upper right
corner of the image.
– In the Review screen, select a image and click [Send to].
2. Select from the destination:

Item Description
USB/iStorage For external memory devices (e.g. USB memory devices, DVD
recorder) or network storage server, you can set:
• PC format transfer.
• DCM format transfer
• Cine Zoom Mode.
• Export the report or the report format.
• Hide patient information.
DICOM/Print/eGateway Select the DICOM Storage, Print server or eGateway server.
MedTouch/MedSight Send the image to MedTouch/MedSight as necessary.
NOTE:
The file sent to MedTouch/MedSight is transferred into PNG
format, and the cine file is transferred into AVI format.

NOTE:
If the transferred AVI file cannot be played normally on PC, please try to transfer the multi-
frame cine file in MP4 format and try Send To function again, or use a VLC media player.

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14.2 Report Management

14.2.1 Report storage
The exam reports are stored under the directory of the exam of the patient.

14.2.2 Importing, exporting and sending a report

Import/export report via Backup
In iStation screen, select patient data, click [Restore Exam] or [Backup Exam] in the popped up
menu to import or export patient information, images and reports from or to an external memory
device.
Perform the following procedure:
1. Click to select patient data, and click [Restore Exam] or [Backup Exam].
2. Select the destination.
3. Select whether to remove from local HD after Backup:
– If “Remove Exams” is selected, the patient information and images are removed.
– If “Remove Images” is selected, only the patient images are removed.
4. Select whether to hide the patient information.
5. Select whether to encrypt backup exams for USB only: input the password and confirm
password in the field box. Click [Backup], a “Patient.7z” compressed package is backed up to
the USB device, and you need to input the password to open the package.
NOTE:
• If the password is forgotten, you cannot open the backup package.
• The password cannot be multi-language or Chinese characters.

Export report via Send To

In the iStation or Review screen, click [Send Exam] or [Send to] to send patient data to an external
memory device (USB disk or disc) or network storage, you can choose if reports are exported.
Perform the following procedure:
1. Check “Export Report” on the screen.
2. Select report type to be exported.
3. Click [OK] to confirm.
The size of the report can be set, see “4.9 Print Preset”.

14.3 Patient Data Management (iStation)

The patient data include basic patient information, exam information, image files and reports.You
can search, view, backup, send, restore, delete or export patient data in iStation.
Do one of the following to enter iStation:
• Tap [iStation] on the exam main screen.
• Click [iStation] in the Patient Info screen.
• Click [iStation] in the Review screen.

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 14 Patient Data Management

14.3.1 Searching a Patient

Perform the following procedure:
1. Select the data source.
Click [Data Source] to select the data source of patient data, the system patient database is
default.
2. Set search conditions in the “Item” drop-down list.
3. Enter the key word. The matching patient information is displayed in the patient list.
4. When you select a patient in the patient list, the images of this patient will be displayed at the
bottom of the screen.

14.3.2 Patient Data View & Management

Select the desired patient information in the list.

Item Description
Review an Select an exam of a patient, click [Review Image] to enter Review screen.
image
Patient Select an exam of a patient, click [Patient Info] to check the patient information
Information of this exam.
Review Report After you select an exam of a patient, click [Review Report] to view the report of
this exam for this patient.
Delete Exam • Select the patient record. Click [Delete Exam] to delete the exam. However,
you cannot delete patient data being printed, exported or sent, or delete the
current exam.
• To delete an image, select the image and click on the right side.
Backup Exam You can back up the selected patient data to the system-supported media in order
to view it on PC, or restore the patient data to the system from an external media.
The exam after being backed up can be restored to the system for another review.
Click to back up the selected patient data to the system-supported media.
• Original format: to back up the data in original format.
• DICOM format: you can change the cine compression mode, and JPEG
compression mode.
• You can select whether to remove images or the whole exam record from the
system.
Restore Exam Click to import the patient data from an external media.
Send Exam You can use this function to export the exam data to external devices (in PC data
or DICOMDIR data format) and then import to PC or restore to the ultrasound
system to review the data.
1. Select the patient record, click [Send Exam] in the menu to send exam data or
images of the selected record.
2. Select from the destination, and set related settings.
Activate an After you select an exam, which has been performed within 24 hours, click
Exam [Activate Exam] to activate the exam and load the basic patient information and
measurement data to continue the exam.
If you want to select a patient data in an external memory database to start a new
exam or recover the exam, you have to first allow the system to load the patient
data to the system’s patient database.

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 14 Patient Data Management

Item Description
Continue an Select an exam that is paused within 24 hours, click [Continue Exam] to activate
Exam the exam and load the basic patient information and measurement data to
continue the exam.
If you want to select a patient data in an external memory database, you have to
first allow the system to load the patient data to the system’s patient database.
Annotation an Select an exam and click [Annotation Exam] to add annotation.
exam In the popped-up screen, you can also review the history annotations for the
selected exam.

14.4 Recycle bin

The recycle bin is used to store deleted patient data, exam data and images.
The system supports recovery of these data from the recycle bin.
Click at the lower right corner of the screen (when the button is gray, the operation is
unavailable) to enter the Patient Recycle Bin screen.

To recover the deleted patient data

NOTE:
If the capacity of the recycle bin exceeds 200. The system reminds the user to clean. Follow the
procedures below to clean the recycle bin.

Perform the following procedure:

1. Select items to be recovered in the list.
2. Select operations:
– Click [Restore Items] to restore the item back to iStation.
– Click [Delete] to delete the item permanently, and the item can never be restored again;
– Click [Restore All Items] to restore all the items back to iStation;
– Click [Empty Recycle Bin] to empty the recycle bin and all items can never be restored
again.
– Click [Exit] to exit the recycle bin.

To set maximum number of days or deleted data to be kept in the recycle bin

NOTE:
The patient exams which exceed the preset maximum will be deleted and unrecoverable, it is
recommended to perform patient data backup before enabling this function to avoid data loss.

Perform the following procedure:

1. Input the desired number besides “Maximum number of days to be kept”.
If the input box is left blank, the feature will not be enabled.
Only the whole number ranging from 1 to 365 can be input.
2. Click [Modify].

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14.5 iStorage
TIP:
To use iStorage function, you need UltraAssist software in 2.0 version (with V1.0 network
protocol); consult Mindray service engineer for details.

Network storage is used to save image files and measurement reports to the remote PC server.
For network storage setting, see “4.8.2 iStorage Preset”.
1. Enter iStation, select one (or more than one) patient data or image in the local data source.
2. Click [Send Exam].
3. Select [iStorage] in the Send To dialog box, and select the PC server of the right side.
4. Select PC transfer format and check whether to send report.
5. Click [OK] to start sending.

14.6 Print
For printer connection, see “3.8 Installing a Printer”.
For user-defined key for printing and video output settings, see “4.1 System Preset”.

14.6.1 Image Print

For DICOM image printing, refer to relevant chapters. Video printer is applied in image print
service.
Perform the following procedure:
1. Select the desired image in iStation or Review screen.
2. Click icon on the upper right side of the image, and select the printer in the popped up
dialog box.
3. Click [OK] to start printing.
Please refer to the accompanying manuals of the printers for more details.

14.6.2 Report Printing

Both reports and images can be printed on a graph/text printer. For detailed information about the
report printing, see Advanced Manual.

14.7 Back up Files using the DVD Drive

CAUTION
During the backup process, if a CD/DVD is forcibly taken out or you perform
other operations, the backup process will fail or the system may malfunction.

TIP:
• Writing data using “Send To” supports the PC format transfer function, while CD/DVD
writing using “Back Up” supports only system-relevant formats.

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 14 Patient Data Management

• The symbol indicates that the input CD/DVD is damaged or contains data in an incorrect
format.

The system supports writing data to CD/DVD using the DVD-RW/DVD+RW drive and reading
data from CD/DVD on the PC.
Perform the following procedure:
1. Put a CD/DVD in the tray.
2. Select the data to be backed up. Select [Send Exam] or [Back up Exam] in the menu which
appears. Select the target drive in the Send To or Back Up Patient Record dialog box.
3. Click [OK] or [Back up] to begin writing when the symbol displays.
4. After the writing process is complete, click to bring up the Disc Option dialog box, and
select [Eject] to eject the CD/DVD.

14.8 Patient Task Management

Click in the bottom-right corner of the screen to bring up the Task Management dialog box.

Storage Task
Displays the DICOM storage task.

DICOM Print Task

Displays the DICOM print task.

Media Storage Task

• DICOM media storage task (including disc and USB devices): In iStation screen, select the
target exam and click [Send Exam], then click DICOMDIR in the menu which appears.
• Back up task (system-relevant format): Select the exam to be backed up in iStation and click
[Back Up Exam].
• Send to external devices (including disc and USB devices): Select exam data or images in the
iStation or Review screen. Click [Send Exam] for the image.
• iStorage task: In iStation screen, select the target exam and click [Send Exam], then click
iStorage in the menu which appears.
• MedTouch/MedSight storage task:
– In iStation screen, send exam to MedTouch/MedTouch devices.
– In Review screen, iStation screen, thumbnail area, send the image(s) to MedTouch/
MedSight devices.

Print Task
Displays image or report printing tasks.
In the Task Management dialog box, the patient ID, name, destination, progress, type, contents and
task created time are displayed.
You can perform the following operations:
• Click [Delete] to delete the task.
• Click [Retry] to retry the failed task.
• Click [Select All] to select all the tasks.

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 14 Patient Data Management

Task Status
When there are tasks underway, the task management icon displays as . Click the icon to check
the process.
When tasks have failed, the task management icon displays as . Click the icon to check the
reason for the failure.
When the task management icon displays as , it means no task is underway or has failed.

DICOM Service Setting

On the Storage Task and DICOM Print Task page, click [Service Setting] to enter the DICOM
service setting screen. For details, see “4.7 DICOM/HL7”.

Troubleshooting
If a serious error occurs, such as network disconnection or operation timeout, the system can try to
reconnect the network. The interval time and maximum retries can be set as desired. For details, see
“4.7.2 DICOM Service Preset”.

14.9 V-Access
The ultrasound system can be used to log on to a remote server to check or modify patient data on
the server.
Perform the following procedure:
1. Press the user-defined key for “V Access” to use the function.
The system brings up a dialog box for entering the IP address of the remote server.
2. Enter the IP address and click [OK].
3. Log on with the server account and password.
4. Check the data transferred and carry out operations as necessary.
After logging in to the remote server, you can switch from the Ultrasound System and the
remote server as follows:
a. Click [Minimize] to exit the remote server and enter the Doppler interface.
b. Press the user-defined key for “V-Access” to enter the remote server again.

14.10 Q-Path
You can use the ultrasound system to check data on browser directly. After you have ordered
storage service of a network website service, you can check data using the website, authorized
account and password (provided by the service vendor). You can open the browser to review
previously sent DICOM data. For Q-Path settings, see “4.8.5 Q-Path Preset”.
Perform the following procedure:
1. Send stored images or worksheet reports from iStation/Review/thumbnail area to the Q-Path
server.
2. Press the user-defined key for “Q-Path” to enable the function.
3. Log in to the Q-Path server through the Q-View browser to check the stored images and
worksheet reports.
4. Click [Esc] to exit the Q-View browser.

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NOTE:
Before using DICOM, please read the electronic file DICOM CONFORMANCE STATEMENT
along with the device.

TIP:
The DICOM package is optional, so the description here is only applicable for the system
configured with the DICOM package.

This system supports the following DICOM functions:

• Verify Connectivity
• DICOM Storage
• DICOM Print
• DICOM Worklist
• MPPS (Modality Performed Procedure Step)
• Storage Commitment
• Query/Retrieve
• Structured Report
• DICOM Medium Storage (DICOMDIR Review)
• DICOM Task Management
If all the DICOM presets on the DICOM Service Preset screen are completed, you are ready for the
Storage, Print, Worklist (HL7 Query), MPPS, Storage Commitment and Query/Retrieve
applications. For detailed information about DICOM presets, see “4.7 DICOM/HL7”.

15.1 DICOM Storage

DICOM Storage is used to send images (single-frame or multi-frame) or structured report to the
DICOM storage server for storage.

15.1.1 Send images on iStation/Review/main screens

Perform the following procedure:
1. Do one of the following to select images:
– Tap [iStation] on the exam main screen to enter the iStation page. Click to select a patient
or an exam record in the list. Thumbnails are displayed in the thumbnail area in the lower
part of the screen, and then click to select a thumbnail or the cine. Or, select an exam or
exams from the patient list (there should be images for this exam).
– Tap [Review] on the exam main screen to enter the Review screen. Click to select a
thumbnail or the cine.
– On the main screen, select a thumbnail or the cine.

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 15 DICOM/HL7

2. Click in the top-right part or [Send To] to bring up the Send To dialog box.
3. Click to select “DICOM” in the Target box on the left side, then select the DICOM storage
server in the Storage Server box on the right side, and click [OK].

15.1.2 To send images using a shortcut key

You can save single-frame images or multi-frame images to a DICOM server while saving to hard
drive using a shortcut key.

TIP:
To define the shortcut key, for details see “4.1.7 Key Configuration”.

Start the ultrasound exam scan. Press the user-defined key to send the image or the cine to DICOM
storage.

15.1.3 To send images to storage after an exam ends

TIP:
To preset Sending/printing after End Exam, for details see “4.1.2 General”.

Start the ultrasound exam scan. Tap [End] to send the image or the cine to DICOM storage
automatically.

15.1.4 Encapsulate PDF

Encapsulate PDF refers to the PDF file is encapsulated in DICOM IOD.
Encapsulated PDF is sent by following the procedures below:
• Send in the unit of single exam.
• The exam with the state of End, Cancel or Stop cannot be sent as encapsulated PDF.
• Check “Encapsulate PDF” in the storage service preset.
• If there is an exam result in the report template, this type of exam should be performed.
Sending the exam or archiving the exam can send the encapsulated PDF file.

15.1.5 Unload DCM file

The image can be unloaded to DCM format and send to the storage media, iStorage.
Perform the following procedure:
1. Select the image, and click .
2. Select “Target” > “iStorage” to export the image in DCM format.
3. Click [OK] to send DCM format file to the external media

15.2 DICOM Print

DICOM Print is used to send images to the DICOM print server for printing.

15.2.1 Print images on iStation/Review/Main screen

Perform the following procedure:
1. Do one of the following to select images:

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– Tap [iStation] on the exam main screen to enter the iStation page. Click to select a patient
or an exam record in the list. Thumbnails are displayed in the thumbnail area in the lower
part of the screen, and then click to select a thumbnail. Or, select an exam or exams from
the patient list (there should be images for this exam).
– Tap [Review] on the exam main screen to enter the Review screen. Click to select a
thumbnail.
– On the main screen, select a thumbnail or the cine.
2. Click in the top-right part or [Send To].
3. Click to select “DICOM” in the Target box on the left side, then select the DICOM print server
on the right side, and click [OK].

15.2.2 To send images to DICOM Print after an exam ends

TIP:
Preset Sending/printing after End Exam, for details see “4.1.2 General”.

Start the scan and obtain the image. Each time [End Exam] is tapped, the system will send the
image to the default DICOM print server for printing.

15.3 Worklist
When the DICOM basic package is configured and the Worklist server has been set, click
[Worklist] in the “Patient Info” screen to query or import the patient data.
The system supports: DICOM, HL7 and eGateway.
Perform the following procedure:
1. Tap [Info] on the touch screen to enter the patient information page.
2. Click [Worklist] to enter the Worklist page.

3. Guarantee the data source: after select the service type, select the worklist server from the
corresponding server.
4. Input the searching condition:

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– DICOM server: Search via patient ID, accession #, key words, AE title, worklist server or
exam date.
– Select HL7 server: Search via patient ID, patient name.
– eGateway server: Search via patient ID, patient name, exam date, and so on.
5. Click [Query]. The scheduled patients, which meet the criteria, are displayed in the lower part
of the screen.
– After the first query, you can perform the second query based on the preview results.The
scheduled patients in the list will update in real time.
– Enter patient ID, patient name, accession # and exam date, the system affords the result in
real-time.
– Select the keyword type, enter the keywords and then click [Query] to search.
To reset the criteria, click [Clear] button.
6. Select the desired patient from the list.
– When there is no exam,
Click [Start Exam], the patient information is imported into the system and then an exam
is started.
Click [Transfer], the patient information is imported into the “Patient Info” screen and it is
opened. After you edit the patient information in the “Patient Info” screen, click [OK] to
start a new exam.
– When there is a current exam,

Click [Start Exam] and a dialog box pops up.

• Start New: Ends the current exam and creates an exam with the selected
patient information.
• Merge: Merges the selected patient information with that of the current exam.
Click [Transfer] and the ‘End Exam’ dialog box pops up. Click [OK] to start a
new exam.

– Click [Show Detail] to see details of patient data.

7. Click [Exit] to exit the Worklist.

15.4 MPPS
MPPS is used to send exam state information to the configured server. This facilitates the other
systems in obtaining the exam progress in time.
After you preset the Worklist server and MPPS server, if the system obtains the patient information
from Worklist server to begin the exam, it will send exam status information to MPPS server of
when the exam is undergoing or ended. If the sending fails, the system resends automatically.

15.5 Storage Commitment

Storage commitment is used to confirm whether the images or structured reports are successfully
stored on the DICOM storage server.
Before using storage commitment, set the associated storage service

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If images are successfully sent to the storage server, the storage commitment server will return to
the information about the successful image storage. In the iStation screen, you will see a tick “√”
marked in the list below .

NOTE:
Multi-frame storage is not allowed if “Allow Multiframe” is not selected (About “Allow
Multiframe” setting, see “4.7.2 DICOM Service Preset”). Even if there is a multi-frame file in the
exam to be sent, only single-frame image storage will be performed. After the storage is complete,
there is no “√” marked in the list of the iStation screen.

15.5.1 Storage commitment after sending images on the

iStation screen
Select the image, the cine or the data, and send it, see “15.1 DICOM Storage”.
The system will send all the images stored in the exam record to the storage server. Meanwhile, it
will send storage commitment to the storage commitment server.

15.5.2 To send storage commitment automatically after an

exam ends
TIP:
• Preset Sending/printing after End Exam, for details see “4.1.2 General”.
• Set the default storage server, and click “Storage Commitment” to connect to the storage
server, see “4.7.2 DICOM Service Preset”.

Start the scan and obtain the image. Tap [End] each time; the system will send the image to the
default DICOM storage server for storage and send storage commitment to the storage commitment
server.
Storage commitment is confined to the whole exam. Not each image sending can be indicated.

15.6 Query/Retrieve
The query/retrieve function is used to query and retrieve patient exam records in a designated
server.
After setting the DICOM query/retrieve server, you can perform the query/retrieve function in the
iStation screen.
1. Tap [iStation] to enter iStation screen.
2. Click [Query/Retrieve] to open Query/Retrieve screen.
3. Select the server in the “Server and Service” area (both the source and the destination) and
query level.
4. Enter the query information, such as Patient ID, Patient Name, Accession #, Exam Date or key
words.
Click [Clear] to empty the entered query information.
5. Click [Query]. The system performs the query and lists the results in the patient (source) list.
You can perform further queries based on the results by entering new query information.
6. Select one or more patient records according to the actual situation.
– Click [Select All] to select all the patient records in the list.

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 15 DICOM/HL7

– Click [Deselect All] to deselect all the patient records in the list.
7. Click [Retrieve] to retrieve the patient records in the DICOM query/retrieve server to the local
machine.
8. Click [Exit]. The retrieved patient records are listed in the iStation screen.

15.7 DICOM Media Storage (DICOMDIR Review)

Patient data in the ultrasound system can be saved on external media in DCM format, while DCM
files can be accessed in the ultrasound system.
DICOM media storage and DICOMDUR review should meet the following conditions:
• There is a DVD disk in the ultrasound device, and it works well.
• File system format of CD/ DVD optical file should be ISO9660, and the optical disk should not
be damaged.
• File system format of DVD optical file should be UDF, and the optical disk should not be
damaged.
• Normally read/write data from the USB ports on the ultrasound system.
• File system format of removable device (USB flash drive) is FAT32 and the media should not
be damaged.

15.7.1 Media Storage

Perform the following procedure:
1. Select patient records in the iStation screen.
2. Click [Send Exam] in the menu which appears to open the dialog box.
3. Select the destination to “DICOMDIR” and DICOM Format as well as compression mode.
You can select to delete the exam or the image after the backup, and select to hide patient
information.
4. Click [OK]. The image from the current exam is sent to the external storage media in DICOM
format.
If the backup is successful, a tick will appear in the Backup list in the iStation screen. If not,
there will be no tick.

TIP:
There must be no DICOMDIR/DCMIMG/IHE_PDI files on the external storage media of the same
name as the one being backed up. Otherwise, the backup cannot proceed. Ensure there is enough
storage space, or the backup may fail due to shortage of space.

15.7.2 Media review

Perform the following procedure:
1. Connect the external media with DCM files to the system.
2. Select the data source in iStation screen, and the visible data will be shown.
3. If there are several types of data on the media, the system will ask you to select the format.
Then, click [DICOMDIR].

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15.7.3 Data Restore

NOTE:
Only system-accessible media can be selected.

After the DICOM format data are saved to external media, restore the data to the ultrasound system.
Connect the external media containing DCM files to the system.
1. In iStation, review the data stored on the external media.
2. Select the data to be restored in iStation.
3. Click [Restore Exam] on the iStation screen.

15.8 Structured Report

The Structured Report (SR) can be sent with meeting the following procedures:
• DICOM structured report installed with the corresponding exam mode;
• The state of the SR should be “Cancel” or “Stop”.
• Set the storage option to “Attach SR When Store Images” or “Only Store SR”, see
“4.7.2 DICOM Service Preset”.
Perform the following procedure:
1. Click to select a patient or an exam record in the list on iStation page, and click [Send Exam] in
the iStation page.
2. Select DICOM in the storage server list, select a server in the “Storage Server” list.
3. Click [OK], the status of sending task can be viewed in task management.
After successful storage of both image and structured report; you can see the storage
commitment mark “√” in the list below on the iStation screen.

NOTE:
Only the PACS system from the Medstreaming company (http://www.medstreaming.com/
default.aspx) supports sending self-defined measurements by DICOM SR.

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16 Probes and Biopsy

16.1 Probes
Table 16-1 Available probes

Probe Model Region Applied Probe Figure

C5-1s Body surface

SC5-1Ns Body surface

V11-3Hs Intracavitary

V11-3s Intracavitary

L13-3s Body surface

L13-3Ns Body surface

L12-3RCs Body surface

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 16 Probes and Biopsy

Probe Model Region Applied Probe Figure

L11-3VNs Body surface

L14-6Ns Body surface

L20-5s Body surface

P4-2s Body surface

SP5-1Ns Body surface

L12-3VNs Body surface

L9-3s Body surface

L16-4Hs Body surface, Intra-

operative

C11-3s Body surface

P10-4s Body surface

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Probe Model Region Applied Probe Figure

P7-3Ts Transesophageal

P8-3Ts Transesophageal

C5-2s Body surface

L12-4s Body surface

P8-2s Body surface

CW2s Body surface

TIP:
Abdominal use of C5-1s, and SC5-1Ns includes gynecology application region.

16.1.1 Probe Functions by Part

The basic structures and corresponding functions of probes are basically the same; take the
following probe as an example.

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 16 Probes and Biopsy

1 2 3 4

No. Item Description

1. Probe head Converts the electrical signal into an ultrasonic signal,
focusing the sound beams in a given direction; meanwhile, it
receives the reflected ultrasonic signal and converts it into an
electrical signal for transmission over the cable. The lens on
the surface is the acoustic lens. Apply ultrasound gel on the
acoustic lens for correct operation.
2. Needle-guided Provides mounting support of the needle-guided bracket.
bracket fix tabs and
grooves NOTE:
This structure of probes in the figure above may vary with
the matched needle-guided brackets.
3. Probe cable Transmits electrical signals between the probe body and
connector.
4. Probe connector Connects the probe and cable to the ultrasonic diagnostic
system.

16.1.2 Orientation of the Ultrasound Image and the Probe

Head
The orientation of the ultrasound image and the probe are shown as below. The “M” side of the
ultrasound image on the monitor corresponds to the mark side of the probe. Check the orientation
before the examination (Using a linear probe as an example).

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 16 Probes and Biopsy

1 Orientation mark
2 Mark

16.1.3 Procedures for Operating

WARNING
Disinfect the probe and sterilize the needle-guided bracket before and after an
ultrasound-guided biopsy procedure is performed. Failure to do so may cause
the probe and the needle-guided bracket becomes a source of infection.

This section describes general procedures for operating the probe. The proper clinical technique to be
used for operating the probe should be selected on the basis of specialized training and clinical
experience.

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 16 Probes and Biopsy

Procedures for operating (with biopsy function)

Inspection before examination

Connection to the system

Examinations
Biopsy procedure
Disconnection to the system
Thoroughly cleaning the needle
guided bracket
Wiping off the ultrasound gel

Sterilization of the needleguided

bracket
Thoroughly cleaning the probe

Inspection after use

Drying the probe

Storage
Disinfecting the probe

Rinsing the probe

Drying the probe

Inspection after use

Storage

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Procedures for operating (with no biopsy function)

Inspection before examination

Connection to the system

Examinations

Disconnection to the system

Wiping off the ultrasound gel

Thoroughly cleaning the probe

Drying the probe

Disinfecting the probe

Rinsing the probe

Drying the probe

Inspection after use

Storage

16.1.4 Wearing the Probe Sheath

CAUTION
• Be sure to cover the probe with a new (unused) probe sheath to prevent
infection during examination. If the package of a probe sheath is open or
broken, the sterilization of the probe sheath may not be sufficient. DO NOT
use such a probe sheath.
• The cover contains natural rubber latex and talc that can cause allergic
reactions in some individuals.
• DO NOT use an expired probe sheath. Before using a probe sheath, verify
whether the term of validity has expired.

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 16 Probes and Biopsy

A legally marketed probe sheath must be installed over the probe before performing intra-cavitary
and intra-operative examination. Protective barriers may be required to minimize disease
transmission. Probe sheaths are available for use with all clinical situations where infection is a
concern.
To order probe sheath, contact:
CIVCO Medical Instruments Co.
102 First Street South, Kalona, IA 52247-9589 USA
Tel: 1-319-656-4447
E-mail: info@civco.com
http://www.civco.com
Refer to the following dimension table of all probes to choose the necessary probe sheath type. You
can select the probe sheath according to the actual application situation.

Probe Mode Length(mm) Width(mm) Height(mm) Cable Length(mm)

C5-1s 111.9 76.7 28 2050±50
SC5-1Ns 111.8 76.7 28 2050±50
V11-3s 317 41 33 2050±50
V11-3Hs 319.6 33 38.1 2050±50
L11-3VNs 43.3 10.4 12.6 2050±50
L12-3RCs 101.8 55.6 22 2050±50
L13-3s 101.6 61 25.7 2050±50
L13-3Ns 101.1 56.8 22 2050±50
L14-6Ns 101.6 61 25.7 2050±50
L20-5s 98 43 22.8 2260±50
P4-2s 102.7 38.1 27.8 2050±50
SP5-1Ns 102 38 30 2050±50
L12-3VNs 101.8 56.8 25.3 2050±50
L9-3s 103.5 58.6 23.3 2050±50
L16-4Hs 41.8 34.6 11.5 2050±50
C11-3s 96.4 32.8 25 2050±50
P10-4s 82.5 28.5 21.1 2050±50
P7-3Ts 1500 59.6 29 1530±50
P8-3Ts 720 63 67.8 1770±50
C5-2s 112.4 76.3 25.6 2050±50
L12-4s 101.6 61 25.7 2050±50
P8-2s 82.7 30.6 23.2 2050±50
CW2s 121.8 79.5 17.8 1950±50

The following figure is a dimension illustration of the V11-3s probe.

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 16 Probes and Biopsy

Perform the following procedure to install the probe sheath:

1. Place an appropriate amount of gel inside the sheath or on the probe acoustic lens. Poor
imaging may result if no gel is used.

2. Insert the probe into the sheath; make sure to use proper sterile technique. Pull cover tightly
over probe acoustic lens to remove wrinkles and air bubbles, and taking care to avoid
puncturing the sheath.

3. Secure the sheath with the enclosed elastic bands.

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 16 Probes and Biopsy

4. Inspect the sheath to ensure there is no hole or tear.

16.1.5 Probes Cleaning and Disinfection/Sterilization

Before and after completing each examination, clean and disinfect (or sterilize) the probes as
required. When biopsy procedures have been performed, be sure to sterilize the needle-guided
bracket. Fail to do so may result in the probe and the needle-guided bracket to becoming sources of
infection. Please follow the instructions in the manual for cleaning.

WARNING
Never immerse the probe connector into liquid such as water or disinfectant.
Immersion may cause electrical shock or malfunction.

CAUTION
• No cleaning and disinfecting may result in the probe becoming a source of
infection.
• Please follow the disinfectant manufacturer’s manual for performing
cleaning and disinfection, including preparing sterile water and cleaning
and disinfection time.

NOTE:
• After the examination, wipe off the ultrasound gel thoroughly. Otherwise, the ultrasound gel
may solidify and degrade the image quality of the probe.
• DO NOT make the probe to become overheated (more than 55 °C) during cleaning and
disinfections. High temperature may cause the probe to become deformed or damaged.
• Observe the graph here carefully to immerse the probe. Only soak parts of the probe below the
strain relief.
• Repeated disinfection will eventually damage the probe, please check the probe performance
periodically.

Cleaning and Disinfection/Sterilization Overview

Cleaning and disinfection refer to two distinct processes. According to the Centers for Disease
Control and Prevention (CDC) “Guideline for Disinfection and Sterilization in Healthcare
Facilities” (2008):
• Cleaning is the removal of visible soil (e.g. organic and inorganic material) from objects and
surfaces and normally is accomplished manually or mechanically using water with detergents

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 16 Probes and Biopsy

or enzymatic products. Thorough cleaning is essential before high-level disinfection and

sterilization because inorganic and organic material that remains on the surfaces of instruments
interfere with the effectiveness of these processes.
• Disinfection describes a process that eliminates many or all pathogenic microorganisms,
except bacterial spores.
– Low-Level Disinfection—Destruction of most bacteria, some viruses, and some fungi.
Low-level disinfection will not necessarily inactivate Mycobacterium tuberculosis or
bacterial spores.
– High-Level Disinfection (HLD)—Destruction/removal of all microorganisms except
bacterial spores.
• Sterilization describes a process that destroys or eliminates all forms of microbial life and is
carried out in healthcare facilities by physical or chemical methods.

Selecting a Microbicidal Method

Probes can be divided into three categories based on their intended use. Some probes may fall into
more than one category (e.g. probes use for biopsy procedures). When selecting a disinfectant,
determine the required level of disinfection based on intended use and possibility of cross-
contamination.
• Contacts intact skin: Probes that only come into contact with clean, intact skin are considered
noncritical devices and require cleaning after every use. Cleaning may be followed by a low-
level disinfectant spray or wipe.
• Contacts mucous membranes and non-intact skin: This category includes all endocavity probes
- intravaginal, transrectal, and transesophageal (TEE) and probes use for biopsy procedures.
These semi-critical probes must be cleaned with an appropriate cleaner after use followed by
high-level disinfection.
• Contacts otherwise sterile tissue or body-space: These probes are considered critical and
include all intraoperative probes. These probes must be cleaned with an appropriate cleaner
after each use, followed by a sterilization process.

Cleaning
Please refer to the instructions in the manual and follow your hospital policy and procedures for
cleaning.
Perform the following procedure:
1. Wear a pair of gloves to prevent infection.
2. Disconnect the probe from the system. If the sheath is used, take off the sheath and discard it.
3. Wipe off the ultrasound gel or other visible dirt on the surface of the probe by using a damp
piece of disposable lint-free soft cloth or tissue.
4. Choose an appropriate cleaning agent including mild detergents, enzymatic cleaners and
specially designed enzymatic sponges.
5. Immerse the probe fully in the cleaning fluid for at least 1 minute or according to
manufacturer’s instructions. Lightly mechanical clean the probe with a piece of lint-free soft
cloth or soft sponge until no dirt is visible. When necessary, clean the seams or biopsy guide
features by using disposable cotton swabs. Avoid using a brush to wash the lens because it may
damage the probe.
6. Rinse the probe thoroughly by using a large amount of clean water (about 7.5 L/2 gallons) at
room temperature for about 30 s to remove the residual dirt and cleaning solvent. Repeat the
rinsing operation twice.
7. Dry the probe by wiping with a piece of disposable lint-free soft cloth or tissue.

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 16 Probes and Biopsy

Do not dry the probe by heating.

8. Inspect the probe. If visible dirt still exists, repeat the preceding steps to wash the probe until it
is all clean.
9. Check whether the probe has defects such as peeling, rifts, bumps, cracks, or liquid spill. If
such defects exist, the probe has reached the end of its service life. In this case, stop using it
and contact the Mindray service department.

Low-level disinfection of a non-critical probe

CAUTION
Use protective eyewear when disinfecting using sprays.

Perform the following procedure:

1. Wear a pair of gloves to prevent infection.
2. Clean the probe thoroughly in accordance with the cleaning procedure before disinfection.
3. Disinfect the probe by using an appropriate low-level disinfectant. Follow the disinfection
agent manufacturer’s instructions for preparation and use of the disinfectant.
– Wipes: Wipe all the surface of the probe according to the wiping duration specified in the
operator’s manual provided by the manufacturer.
– Spray: Spray the disinfectant directly on the surface of the probe or spray the disinfectant
on a piece of disposable lint-free soft cloth and wipe the probe according to the wiping
duration in the operator’s manual provided by the manufacturer.
Observe the graph here carefully to perform disinfection. Do not spray the strain relief on the
connector end or the connector.

Connector
Strain relief

4. Wipe away the residual disinfectant on the probe by using a piece of lint-free soft cloth soaked
with clean water. Wipe three times. Or rinse the probe thoroughly by using a large amount of
clean water (about 7.5 L/2 gallons) at room temperature.
5. Dry the probe by wiping with a piece of disposable lint-free soft cloth. Do not dry the probe by
heating.
6. Check whether the probe has defects such as peeling, rifts, bumps, cracks, or liquid spill. If
such defects exist, the probe has reached the end of its service life. In this case, stop using it
and contact the Mindray service department.
7. Store the probe in a cool, clean and dry environment. And repeat the cleaning and disinfection
process before the next use.

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High-level disinfection of a semi-critical probe

Perform the following procedure:
1. Wear a pair of gloves to prevent infection.
2. Clean the probe thoroughly in accordance with the cleaning procedure before disinfection.
3. Disinfect the probe by using an appropriate high-level disinfectant or system. For how to use a
high-level disinfectant or system, see the operator’s manual provided by the manufacturer.
Prepare a disinfectant by using sterile distilled or softened water when necessary.
– Soaking: Immerse the probe head in the disinfectant and shake the probe appropriately to
remove any bubbles on the probe surface. For details about the probe immersion duration,
see the operator’s manual provided by the manufacturer.
Observe the graph here carefully to immerse the probe. Only soak parts of the probe
below the strain relief.

Strain relief

Probe handle Fluid level

– Wiping: Use a market disinfection wipe product or sterile disposable lint-free soft cloth
wetted with disinfection spray and wipe all surfaces of the probe for a duration according
to the manufacturer instructions.
4. Rinse the probe thoroughly by using a large amount of clean water (about 7.5 L/2 gallons) at
room temperature for about 30 s to remove the residual disinfectant. Repeat the operation
twice. Or follow the disinfectant manufacturer’s instructions regarding rinsing.
5. Dry the probe by wiping with a piece of clean disposable lint-free soft cloth. Do not dry the
probe by heating.
6. Check whether the probe has defects such as peeling, rifts, bumps, cracks, or liquid spill. If
such defects exist, the probe has reached the end of its service life. In this case, stop using it
and contact the Mindray service department.
7. Store the probe in a cool, clean and dry environment. And repeat the cleaning and disinfection
process before the next use.

Sterilization of a critical probe

CAUTION
Repeated sterilization will eventually damage the probe, please check the
probe’s performance periodically.

For intra-operative probes, they have to be thoroughly cleaned and sterilized after completing each
examination.
Perform the following procedure:

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 16 Probes and Biopsy

1. Wear a pair of gloves to prevent infection.

2. Clean the probe thoroughly in accordance with the cleaning procedure before sterilization.
3. Sterilize the probe by using an appropriate sterilant or system.
For how to use a system, see the operator’s manual provided by the manufacturer.
When using a sterilant, follow the following steps:
a. Prepare a sterilant by using sterile distilled or softened water when necessary.
b. Immerse the probe head in the sterilant and shake the probe appropriately to remove any
bubbles on the probe surface.
For details about the probe immersion duration, see the operator’s manual provided by the
manufacturer.

Fluid level

c. Rinse the probe thoroughly by using a large amount of sterile distilled or softened water
(about 2 gallons) at room temperature for about 30 s to remove the residual disinfectant.
Repeat the operation twice. Or follow the sterilant manufacturer’s instructions regarding
rinsing.
d. Dry the probe by wiping with a piece of sterile disposable lint-free soft cloth.
Do not dry the probe by heating.
4. Check whether the probe has defects such as peeling, rifts, bumps, cracks, or liquid spill. If
such defects exist, the probe has reached the end of its service life. In this case, stop using it
and contact the Mindray service department.
5. Store the probe in a cool, clean and dry environment. And repeat the cleaning and sterilization
process before the next use.

Compatible Cleaners and Disinfectants

For the detailed information about cleaners and disinfectants, see Mindray Transducer Disinfectant
Recommendation.

16.1.6 Cleaning the probe cable and connector

NOTE:
Do not use cloth with water to clean the probe connector.

Perform the following procedure:

1. Wipe out the dust attached to surface of probe connector and cable.
2. Use soft brush to brush the dust inside probe connector gently.
3. Remained stain or dust attached to surface of cable or surface of connector should be washed
out by cloth with a little soapy water, and then air-dry.

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16.1.7 Probe Environmental Conditions

Table 16-2 Probe Environmental Conditions

Probe Conditions Ambient Relative humidity Atmospheric
Model temperature (no condensation) pressure
C5-1s Operating 0°C ~ 40°C 30% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 30% ~ 95% 700 hPa ~ 1060 hPa
transportation
C5-2s Operating 0°C ~ 40°C 30% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 30% ~ 95% 700 hPa ~ 1060 hPa
transportation
C11-3s Operating 0°C ~ 40°C 30% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 30% ~ 95% 700 hPa ~ 1060 hPa
transportation
SC5-1Ns Operating 0°C ~ 40°C 20% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 20% ~ 95% 700 hPa ~ 1060 hPa
transportation
V11-3s Operating 0°C ~ 40°C 30% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 30% ~ 95% 700 hPa ~ 1060 hPa
transportation
V11-3Hs Operating 0°C ~ 40°C 20% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 20% ~ 95% 700 hPa ~ 1060 hPa
transportation
L9-3s Operating 0°C ~ 40°C 20% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 20% ~ 95% 700 hPa ~ 1060 hPa
transportation
L11-3VNs Operating 0°C ~ 40°C 20% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 20% ~ 95% 700 hPa ~ 1060 hPa
transportation
L12-3VNs Operating 0°C ~ 40°C 20% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 20% ~ 95% 700 hPa ~ 1060 hPa
transportation
L12-3RCs Operating 0°C ~ 40°C 20% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 20% ~ 95% 700 hPa ~ 1060 hPa
transportation
L12-4s Operating 0°C ~ 40°C 30% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 30%~95% 700 hPa ~ 1060 hPa
transportation
L13-3s Operating 0°C ~ 40°C 20% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 20% ~ 95% 700 hPa ~ 1060 hPa
transportation

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Table 16-2 Probe Environmental Conditions

Probe Conditions Ambient Relative humidity Atmospheric
Model temperature (no condensation) pressure
L14-6Ns Operating 0°C ~ 40°C 30% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 30% ~ 95% 700 hPa ~ 1060 hPa
transportation
L16-4Hs Operating 10°C ~ 40°C 30% ~ 85% 700 hPa ~ 1060 hPa
Storage and 0°C~ 60°C 30% ~ 95% 700 hPa ~ 1060 hPa
transportation
L20-5s Operating 0°C ~ 35°C 15% ~ 80% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 60°C 15% ~ 90% 500 hPa ~ 1060 hPa
transportation
L13-3Ns Operating 0°C ~ 40°C 20% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 20% ~ 95% 700 hPa ~ 1060 hPa
transportation
P4-2s Operating 0°C ~ 40°C 30% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 30% ~ 95% 700 hPa ~ 1060 hPa
transportation
P8-2s Operating 0°C ~ 40°C 20% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 20% ~ 95% 700 hPa ~ 1060 hPa
transportation
P10-4s Operating 0°C ~ 40°C 30% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 30% ~ 95% 700 hPa ~ 1060 hPa
transportation
SP5-1Ns Operating 0°C ~ 40°C 20% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 20% ~ 95% 700 hPa ~ 1060 hPa
transportation
CW2s Operating 0°C ~ 40°C 30% ~ 85% 700 hPa ~ 1060 hPa
Storage and -20°C ~ 55°C 30% ~ 95% 700 hPa ~ 1060 hPa
transportation

16.1.8 Storage and Transportation

When all examinations for the day have been completed, confirm that the probe is in good
condition. After disinfecting the probe, confirm that the probe is in good condition and stored in a
suitable place
• To prevent the probe from being damaged, DO NOT store it in locations where it may be
exposed to:
– Direct sunlight or X-rays
– Sudden changes in temperature
– Dust
– Excessive vibration
– Heat generators

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• When the probe is sent to MINDRAY Customer Service Department or sales representative for
repair, be sure to disinfect it and keep it in the carrying case to prevent infection.

16.2 Biopsy Guide

WARNING
• The person performing biopsy procedures must understand diagnostic
ultrasound thoroughly and have been trained adequately, otherwise, side
effects may be caused to the patient.
• In situations listed below, the biopsy needle may fail to penetrate the target.
The incorrect biopsy may cause various side effects in the patient.
– Use a needle-guided bracket other than that provided.
– Mount the needle-guided bracket incorrectly.
– Use a biopsy needle that is unsuitable for the type of biopsy being
performed.
– Use a biopsy needle that is unsuitable for the needle guide.
• Before and after a biopsy procedure is performed, confirm that the needle-
guided bracket is normal. Manually confirm that the parts of the needle-
guided bracket do not slip off or move from their proper positions. If the
needle-guided bracket is used when parts are not securely and correctly
installed, the patient may be injured. If an abnormality is found on the
needle-guided bracket, immediately stop using it and contact MINDRAY
Customer Service Department or sales representative.
• Needle guided brackets are required to verified before each biopsy. If the
verification fails, it indicates that the needle-guided brackets are out of
service life.
• Disposable brackets are packaged sterile and are single-use only, and the
method of sterilization is irradiation. Do not use if the sterile packaging is
open or broken, and do not reuse or resterilize the disposable brackets.
• DO NOT use a needle-guided bracket when scanning is performed. The
needle may advance in an incorrect direction and possibly injure the
patient.
Never perform a biopsy during image scanning.
• DO NOT freeze an image while performing biopsy procedure.
• During biopsy procedures, the needle may deviate from the desired course
due to the tissue characteristics or the type of needle. In particular, needles
of small diameters may deviate to a greater degree.
• Disinfect the probe and sterilize needle-guided bracket before and after
each ultrasound-guided biopsy procedure is performed. Fail to do so may
cause the probe and the needle-guided bracket become sources of
infection.
• The needle mark displayed on the ultrasound image does not indicate the
actual position of the biopsy needle. Therefore, it should only be used as a

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reference. Always monitor the relative positions of the biopsy needle during
the procedures.
• Adjust the needle mark before the biopsy procedure is performed.
• When performing biopsy procedures, use only sterile ultrasound gel that is
certified to be safe. And manage the ultrasound gel properly to ensure that
it does not become a source of infection.
• When performing the operation concerning biopsy, wear sterile gloves.
• Image of the biopsy target and the actual position of the biopsy needle:
Diagnostic ultrasound systems produce tomographic plane images with
information of a certain thickness in the thickness direction of the probe.
(That is to say, the information shown in the images consist all the
information scanned in the thickness direction of the probe.) So, even
though the biopsy needle appears to have penetrated the target object in
the image, it may not actually have done so. When the target for biopsy is
small, dispersion of the ultrasound beam may lead to image deviate from
the actual position. Pay attention to this.
If the target object and the biopsy needle appear in the image as shown in
the figures below (For reference only):

The biopsy needle appears to reach the target object Dispersion of the
in the image ultrasound beam

Probe

Biopsy

Needle

Target Ultrasound
beam
Target

The biopsy needle may not have actually entered the target object even
though it appears to have done so in the image. To avoid this, note the
points below:
– Do not rely only on the needle tip in the image. Pay careful attention to
the fact that when the biopsy needle enters the target object or comes
into contact with it, the object should shift slightly.
– Before performing the biopsy, evaluate the size of the object and
confirm whether the biopsy can be carried out.

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16.2.1 Needle-guided Brackets Available

Some of the probes have matched needle-guided brackets for biopsy, the available probes and the
corresponding needle-guided brackets are listed as follows.

Table 16-3 Needle-guided Brackets Available

Probe Model Needle-guided Biopsy angle/ Applicable Biopsy Needle
Bracket Model depth(±1°)
V11-3s NGB-004 / 16G, 17G, 18G
Metal-needle
undetachable
L12-4s NGB-007 40°, 50°, 60° Metal: 14G, 16G, 18G, 20G, 22G
L13-3s plastic/needle Plastic: 13G, 15G, 16G, 18G, 20G
L14-6Ns detachable
Metal-needle
detachable
SP5-1Ns NGB-011 11°, 23° 13G, 15G, 16G, 18G, 20G
P4-2s Metal-needle
undetachable
C5-2s NGB-015 25°, 35°, 45° 14G, 16G, 18G, 20G, 22G
Metal-needle
detachable
C11-3s NGB-018 15°, 25°, 35° 14G, 16G, 18G, 20G, 22G
Metal-needle
detachable
C5-1sSC5-1Ns NGB-022 25°, 35°, 45° 14G, 16G, 18G, 20G, 22G
Metal-needle
detachable
V11-3Hs NGB-025 1.6° 16G, 17G, 18G
Metal-needle
undetachable
L9-3s NGB-034 40°, 50°, 60° 14G, 16G, 18G, 20G, 22G
Metal-needle
detachable
L12-3RCs NGB-043 Angle range: 35° ~ 80° 20G, 21G, 22G, 23G
Metal-needle
detachable
NGB-044 Biopsy depth: 5mm, 18G, 20G, 21G
Metal-needle 10mm, 15mm, 25mm,
detachable 35mm
V11-3s NGB-045 1° 16G, 17G, 18G
Metal-needle
undetachable
L13-3Ns NGB-053 40°, 50°, 60° 11G, 23G
Metal-needle
detachable

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 16 Probes and Biopsy

Table 16-4 Disposable Brackets

Probe Model Needle-guided Bracket Model
V11-3s CIVCO 610-543
CIVCO 610-1274
L12-4s, L13-3s, L14-6Ns CIVCO 658-001
C5-2s CIVCO 658-002

16.2.2 Needle-Guided Bracket Inspection and Installation

A needle-guided bracket is available for purchase as an optional accessory; it is used in
combination with the probe. Some of the probes have matched needle-guided bracket and needles.
To order needle-guided brackets, contact MINDRAY Customer Service Department or sales
representative.
For biopsy or treatment, ultrasound-guided biopsy procedures can be performed using the probe in
combination with a needle-guided bracket (optional accessory) and a biopsy needle (provided by
the user).
Be sure to perform inspections before and after use of the needle-guided bracket. If an abnormality
is found on the needle-guided bracket, immediately stop using it and contact MINDRAY Customer
Service Department or sales representative.
• Sterilize the needle-guided bracket before and after use.
• Put on the sterile probe sheath before installing to the probe.
• Confirm that the needle-guided bracket is free of damage, deformation, stripping, malfunction,
loose, or missing parts.
• Confirm that the needle-guided bracket is securely mounted in the correct position.
• Select the proper needle according to the specification above, and adjust the needle shift to the
same specification of the selected needle.

NGB-004 Metal-needle undetachable needle-guided bracket

3 4
2
1

1 Locating bulge
2 Needle guide
3 Locking nut
4 Retaining clamp
5 Probe

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 16 Probes and Biopsy

6 Locating groove

Perform the following procedure:

1. Install the needle-guided bracket:
a. Put on the sterile probe sheath.

b. Open the retaining clamp, align the needle-guided bracket with the probe to align the
locating bulge on the needle guide with the locating grooves on the probe, then turn the
retaining clamp to align it with the probe.

c. When the retaining clamp is turned to the correct position, the locking nut will lock the
retaining clamp and the needle-guided bracket is then mounted in the correct position.

2. Remove the needle-guided bracket:

Hold the probe in your left hand. Unscrew the locking nut with your right hand to open the
retaining clamp, then raise the needle-guided bracket to separate the locating bulge from the
locating grooves.

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 16 Probes and Biopsy

NGB-007 Metal/needle detachable needle-guided bracket

1 Support for needle-guided bracket

2 Tab and groove for the needle-guided bracket
3 Angle-adjusting base
4 Angle shift sign
5 Angle pinch nut
6 Angle block
7 Guiding block
8 Guiding block specification
9 Needle guide hole
10 Needle-guided bracket pinch nut

Perform the following procedure:

1. Install the needle-guided bracket:
a. Put on the sterile probe sheath.
b. Hold the probe in one hand, select the correct needle-guided bracket and hold it with the
other hand. Match the groove and tab with the tab and groove of the probe respectively.
Mount the bracket onto the probe.

c. Screw the pinch nut of the needle-guided bracket to ensure that the needle-guided bracket
is properly installed on the probe.

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 16 Probes and Biopsy

2. Adjust the needle angle to the proper shift as required:

a. Loosen the angle pinch nut.
b. Adjust the angle block to the desired level.
c. Tighten the angle pinch nut.
3. Install the guiding block
a. Select a suitable guiding block and push it into the groove above the angle block, then
clamp it tightly

b. Screw the block's nut to secure the block.

c. Insert a biopsy needle with the same specification as that of the guiding block into the
guiding block hole.

4. Release the needle from the bracket:

a. Screw the nut of the guiding block and remove the guiding block slightly along the
direction of the needle’s tail.
b. Separate the residual part of the needle-guide bracket and the probe from the needle.

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 16 Probes and Biopsy

5. Remove the needle-guided bracket:

a. Unscrew the Needle-guided bracket pinch nut, and remove the needle-guided bracket
from the probe.
b. Separate the probe and the needle-guided bracket.

NGB-007 Plastic/needle detachable needle-guided bracket

1 Support of needle-guided bracket

2 Angle block
3 Guiding block
4 Groove and tab of the needle-guided bracket
5 Specification of guiding block
6 Guiding hole of the biopsy needle
7 Specification of angle block

Perform the following procedure:

1. Install the needle-guided bracket:
a. Put on the sterile probe sheath.
b. Hold the probe by one hand, select the proper needle-guided bracket, and hold it with the
other hand. Align the narrow end tab of the needle-guided bracket with the groove of the
probe, then push the needle-guided bracket forward, making the tabs and the grooves of
the needle-guided bracket to match with the grooves and tabs of the probe.

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 16 Probes and Biopsy

c. Check manually to confirm that the needle-guided bracket is securely installed on the
probe.
2. Install the guiding block:
a. Select a proper guiding block and push it into the groove above the angle block, and
clamp it tightly.

b. Insert a biopsy needle with the same specification as that of the guiding block into the
hole of the guiding block.

3. Release the needle from the bracket:

a. Remove the guiding block slightly along the direction of the needle’s tail.

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 16 Probes and Biopsy

b. Separate the residual part of the needle-guide bracket and the probe from the needle.
4. Remove the needle-guided bracket:

Remove the support of needle-guided bracket from the probe.

NGB-011 Metal-needle undetachable needle-guided bracket

6
7

4
5
2 3

1 Clamp
2 Locating groove
3 Grip knob
4 Needle guide rack
5 Needle guide hole
6 Needle guide clamping knob
7 Needle guide
8 Locating pit

Perform the following procedure:

1. Install the needle-guided bracket:
a. Put on the sterile probe sheath.
b. Connect the locating groove on the clamp with the two raised edges on the probe head and
align the locating pit of the clamp with the convex point on the probe head.
c. Turn the grip knob at the tail of the needle-guided bracket tightly.
2. Remove the needle-guided bracket:
Hold the probe and the needle-guided bracket, then open the grip knob of the needle-guided
bracket.

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NGB-015/NGB-022 Metal-needle detachable needle-guided bracket

2 3 4 5 6 7 8 9 10 11

1 Groove
2 Clamp
3 Needle type adjusting base
4 Needle type dial scale
5 Needle fixing nut
6 V-shaped cover
7 Angle adjusting base
8 Angle shift sign
9 Angle pinch nut
10 Angle block
11 Pinch nut

Perform the following procedure:

1. Install the needle-guided bracket:
a. Put on the sterile probe sheath.
b. Hold the probe by one hand, select the proper needle-guided bracket, and hold it with the
other hand. Match the groove of the bracket with the tab of the probe. Amount the bracket
onto the probe.

c. Screw the pinch nut of the needle-guided bracket to confirm that the needle-guided
bracket is properly installed on the probe.
2. Adjust the needle angle to the proper shift as required:
a. Loosen the angle pinch nut.
b. Adjust the angle block to the desired level.
c. Tighten the angle pinch nut.
3. Insert the biopsy needle:

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 16 Probes and Biopsy

a. Adjust the dial scale to the required needle type shift, and then screw the needle fixing nut
to lock the dial scale. (To adjust the dial scale you have to loosen the needle fixing nut
first.)
b. Pull the lock pin and close the V-shaped cover to fix the lock pin in the groove of the
needle type adjusting base, so as to install the needle into the guiding hole.
4. Release the needle from the bracket:

a. Pull the lock pin and open up the V-shaped cover to expose the needle.
b. Separate the bracket and the probe from the needle.
5. Remove the needle-guided bracket:

a. Screw the pinch nut to release the needle-guided bracket.

b. Separate the bracket and the probe.

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NGB-018 Metal-needle detachable needle-guided bracket

10
9
8

1 7
2 6

3 5

1 Pinch nut of bracket

2 Angle pinch nut
3 Angle block
4 Clamp
5 Groove
6 Angle-adjusting base
7 Angle shift sign
8 Guiding block specification
9 Guiding block
10 Needle guide hole

Perform the following procedure:

1. Install the needle-guided bracket:

a. Put on the sterile probe sheath.

b. Select a suitable needle-guided bracket and match the groove to the tab of the probe.
Mount the bracket onto the probe.
c. Screw the pinch nut of the needle-guided bracket to ensure that the needle-guided bracket
is properly installed on the probe.
2. Adjust the needle angle to the proper shift as required:
a. Loosen the angle pinch nut.
b. Adjust the angle block to the desired level.
c. Tighten the angle pinch nut.

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 16 Probes and Biopsy

3. Install the guiding block:

a. Select a suitable guiding block and push it into the groove above the angle block
b. Screw the block's nut to secure the block.
c. Insert a biopsy needle with the same specification as that of the guiding block into the
guiding block hole.
4. Release the needle from the bracket:

a. Loosen the guiding block's nut and slightly move the guiding block in the direction of the
needle’s tail.
b. Separate the residual part of the needle-guide bracket and the probe from the needle.
5. Remove the needle-guided bracket:

a. Screw the pinch nut to release the needle-guided bracket

b. Separate the bracket and the probe.

NGB-025 Metal-needle undetachable needle-guided bracket

8 7 6
1
5

3 4

1 Pinch nut
2 Intra-cavity probe
3 Lower clamp

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4 Location hole
5 Front slot
6 Front clamp
7 Location clamp
8 Upper clamp

Perform the following procedure:

1. Install the needle-guided bracket:
a. Put on the sterile probe sheath.

b. Open the clamp. Insert the front clamp to the front groove, and align front clamp with
front groove.

c. Push the biopsy forward (arrow’s direction) until the locating pole inserting into the
location hole. Turn the lower clamp against the intra-cavity probe. Tighten the nut to lock
the biopsy (arrow’s direction)

2. Remove the needle-guided bracket:

a. Hold the prober in the left hand; unscrew the locking nut with the right hand to loose the
clamp (arrow’s direction).

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 16 Probes and Biopsy

b. Lift the biopsy up (towards arrow’s direction). The locating pole, front clamp, the locating
hole and the front clamp become loose.

NGB-034 Metal-needle detachable needle-guided bracket

11 10 9 8 7
1
6

5
2

1 Needle fixing nut

2 Guiding groove
3 Angle fixing nut
4 Angle adjusting base
5 Needle type dial scale
6 Needle adjusting base
7 V-shape cover
8 Lock pin
9 Needle guide hole
10 V-shaped guiding block
11 Clamp

Perform the following procedure:

1. Install the needle-guided bracket:

a. Put on the sterile probe sheath.

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b. Select a proper needle-guided bracket, and match the locating groove with the tab of the
probe. Mount the bracket onto the probe.
c. Tighten the pinch nut of the needle-guided bracket to confirm that the needle-guided
bracket is properly installed on the probe.
2. Adjust the needle angle to the proper shift as required:
a. Loosen the angle pinch nut.
b. Adjust the angle block to the desired level.
c. Tighten the angle pinch nut.
3. Insert the biopsy needle:
a. Adjust the dial scale to the required needle type shift.
b. Pull the lock pin and close the V-shaped cover to fix the lock pin in the groove of the
needle type adjusting base, so as to install the needle into the guiding hole.
4. Release the needle from the bracket:

a. Pull the lock pin out until the V-shaped cover can be turned and opened up.
b. Turn over the V-shaped cover to expose the needle. Remove the probe and bracket.
5. Remove the needle-guided bracket:

a. Unscrew the pinch nut to release the needle-guided bracket.

b. Hold the probe and take out the bracket.

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 16 Probes and Biopsy

NGB-043 Metal-needle detachable needle-guided bracket

5

1 4

2
3

1 Locking nut of left and right clamps

2 Groove
3 Guide frame
4 Guide block hole
5 Clamps

Perform the following procedure:

1. Install the needle-guided bracket:
a. Put on the sterile probe sheath.
b. Hold the probe in one hand, select the correct needle-guided bracket and hold it with the
other hand. Match the grooves of the needle-guided bracket to the tabs of the probe.
c. Mount the bracket onto the probe, and rotate the locking nut to fix the bracket.
2. Insert the biopsy needle:

a. Insert a biopsy needle into the guiding block hole.

b. Adjust the biopsy angle of the needle, and ensure that the needle can be adjusted
continuously within the range of 30º to 85º.
3. Release the needle from the bracket:
Hold the probe, and remove the biopsy needle form the guiding hole of the guiding block.
4. Remove the needle-guided bracket:

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a. Rotate the locking nut in the direction of the arrow shown on the figure to separate the
bracket from the probe.
b. Hold the probe and take out the bracket.

NGB-044 Metal-needle detachable needle-guided bracket

1 2 3 4

8 7 6 5

1 Right clamp
2 Groove
3 Guiding block fixing frame
4 Locking nut of left and right clamps
5 Guiding blocks
6 Depth shift sign
7 Depth pinch nut
8 Left clamp

Perform the following procedure:

1. Install the needle-guided bracket:

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 16 Probes and Biopsy

a. Put on the sterile probe sheath.

b. Hold the probe in one hand, select the correct needle-guided bracket and hold it with the
other hand. Match the grooves of the needle-guided bracket to the tabs of the probe.
c. Mount the bracket onto the probe, and rotate the locking nut to fix the bracket.
2. Adjust the needle angle to the proper shift as required:

a. Loosen the depth pinch nut.

b. Adjust the depth shift to the desired level.
c. Tighten the depth pinch nut.
3. Insert the biopsy needle:
a. Select a suitable guiding block and loosen its nut, install the guiding block to the guiding
block fixing frame, then tighten the block nut tightly.

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b. Insert a biopsy needle with the same specification as that of the guiding block into the
guiding block hole

4. Remove the needle-guided bracket:

a. Hold the probe and remove the needle.
b. Loosen the guiding block nut, and remove it from the guiding block fixing frame.

c. Rotate the clamping nuts of the needle guided-bracket. The needle guided-bracket is
separate from the probe. Hold the probe and take out the bracket.

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 16 Probes and Biopsy

NGB-045 Metal-needle undetachable needle-guided bracket

3

5
4

1 Needle exit
2 Needle guide
3 Needle entry
4 Retaining clamp
5 Locating bulges

Perform the following procedure:

1. Install the needle-guided bracket:
a. Put on the sterile probe sheath.

b. Align the needle-guided bracket with the probe to align the locating bulges on the needle
guide with the locating grooves on the probe, then turn the retaining clamp to the correct
position.

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c. Hold the probe, and insert the needle into Needle entry of the needle guide.

2. Remove the needle-guided bracket:

a. Hold the probe and remove the needle.

b. Hold the probe and raise the needle-guided bracket to separate the locating bulge from the
locating grooves.

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NGB-053 Metal-needle detachable needle-guided bracket

1 2 3 4

7 6 5

1 Clamp pinch nut

2 Clamps
3 Angle pinch nut
4 Separation pressure position
5 Needle type adjusting nut
6 Needle guide hole
7 The location position block

Perform the following procedure:

1. Install the needle-guided bracket:
a. Put on the sterile probe sheath.
b. Hold the probe in one hand, select the correct needle-guided bracket and hold it with the
other hand. Match the grooves of the needle-guided bracket to the tabs of the probe.
c. Mount the bracket onto the probe, and rotate the pinch nut to fix the bracket.
2. Adjust the needle angle to the proper shift as required:
a. Loosen the angle pinch nut.
b. Adjust the angle block to the desired level.
c. Tighten the angle pinch nut.
3. Insert the biopsy needle:
a. Hold the probe. Press the separation pressure position to separate needle guided V-shaped
block from pressure position of the needle.
b. Put the needle into the needle guided-bracket, and the needle leans to V-shaped block.
c. Hold the probe, and release the pressure position of the needle. Adjust the needle-type
adjusting nut manually. The needle moves smoothly at the vertical direction due to its
gravity.
4. Release the needle from the bracket:
a. Hold the probe. Press the biopsy needle to separate the needle from pressure position of
the needle.
b. Separate the bracket and the probe from the needle.

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5. Remove the needle-guided bracket:

a. Rotate the pinch nut of the needle guided-bracket.
The needle guided-bracket is separate from the probe.
b. Hold the probe and take out the bracket.

16.2.3 Verifying the Biopsy Guide Line

WARNING
• Prior to each biopsy procedure, be sure to verify the guide line.
• If the needle is not consistent with the guide line, DO NOT perform the
biopsy procedure.

NOTE:
You can perform guide line verification on a single live B/C image, and all biopsy-irrelevant
operations are forbidden.

Adjusting the needle mark is necessary before each biopsy procedure.

Perform the following procedure:
1. Confirm that the needle-guided bracket has been installed securely in the correct position.
2. Prepare a container filled with sterile water.
3. Place the head of the probe in the sterile water and place a biopsy needle in the needle guide.
4. When the biopsy needle appears on the image, confirm that the biopsy needle is displayed at
almost the same position as the selected needle mark.
5. Tap [Biopsy] to enter Biopsy.
– Select the biopsy bracket angle/guide line: If the needle-guided bracket supports more
than one biopsy angle, select the angle/guideline by using [Biopsy Kit].
– Select the guide line dot size: Tap [Dot Size] to select the dot size.
NOTE:
• The distance between two dots is depth-dependent. Move the cursor over the big dot
and a numeral, representing the biopsy depth, is displayed.
• The biopsy guidezone adjusts along with image adjustments, such as image inversion/
rotations, zoom and depth changes.
• When the imaging depth and area are changed, the guide line is adjusted.
6. Tap [Verify] in the Biopsy tab to open the Biopsy Verify menu.
– Adjust the guide line position: Use [Position] to change the position of the guide line.
– Adjust the angle: Use [Angle] to change the guide line angle.
– Save the verified settings: After the position and angle of the guide line are adjusted, tap
[Save] and the system saves the current guide line settings. If biopsy is entered again, the
displayed Position and Angle are the verified value.
– Restore the factory default settings: Tap [Load Factory] and the position and angle of the
guide line are restored to the factory default settings.
– Exit biopsy verify status: Tap [Exit] and the system exits the guide line verification status.

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 16 Probes and Biopsy

16.2.4 Starting the biopsy procedure

DANGER
• Ensure that all guide parts are properly fixed prior to performing a biopsy.
• If you changed the probe or needle-guided bracket during the biopsy, verify
the guide line again.
• Failure to match the guide zone displayed to the guide may cause the
needle to track a path outside the zone.
• It is extremely important that when using the adjustable angle biopsy
guides, the angle displayed on the screen matches the angle set on the
guide, otherwise the needle will not follow the displayed guide zone and
this could result in repeated biopsies or patient injury.

Perform the following procedure:

1. Select the correct needle-guided bracket and needle and install them properly.
2. Tap [Biopsy] to enter the biopsy.
If the current probe has no corresponding bracket, or the image is frozen and the guide line was
hidden before the image was frozen, then you cannot enter the Biopsy menu.
3. Select the bracket and guide line according to the actual situation.
Tap [Verify] to enter Biopsy Verify menu to fine tune the guide line if needed.
4. If available, use iNeedle function to help enhance the needle visualization when the needle
display is not clear.
iNeedle is an option.
a. Tap [iNeedle] in B menu.
The parameters that can be adjusted appear on the menu:
[B/iNeedle]: tap to display B image and iNeedle image synchronously.
[Needle Dir.]: select to adjust the needle direction display according to actual direction of
needle insertion. The iNeedle affecting region changes correspondingly.
b. Tap [iNeedle] again to exit iNeedle.
5. Scan to locate the target. Center the target in the electronic guidezone path.
6. Direct the needle into the area of interest for specimen.
7. After extracting the biopsy sample is complete, gently remove the probe from the body.
8. Tap [Exit] to exit the Biopsy menu
9. Disassemble the items and properly dispose of these items as required.

16.2.5 Clean and Sterilize the Needle-Guided Bracket

CAUTION
• Needle-guided brackets whose name starts with NGB are reusable, and
need thorough cleaning and sterilization before and after each biopsy.
• Follow local regulations when selecting and using the disinfectant.

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• Repeated sterilization may degrade the safety and performance of the

needle-guided bracket. Before use, please check whether the needle-
guided bracket has defects such as deformation and rusting. If such
defects exist, the bracket has reached the end of its service life. In this
case, stop using it and contact the Mindray service department.
• It is recommended to use immersion sterilization for plastic needle-guided
brackets and high-pressure steam sterilization for metal needle-guided
brackets.
• For detailed operations about the cleaning solvent, sterilant and high-
temperature steam sterilizer, see the respective operator’s manuals
provided by the manufacturer.

NOTE:
Disposable components are packaged sterile and are single-use only. Do not use if integrity of
packaging is violated or if expiration date has passed. Please use the disposable components
compliant with the relevant local regulations.

Cleaning
Perform the following procedure:
1. Wear a pair of gloves to prevent infection.
2. After use, immerse the needle-guided bracket in distilled water immediately to prevent dirt
from drying. Wipe the entire surface of the needle-guided bracket by using a piece of
disposable lint-free soft cloth to remove coarse dirt.
3. Prepare a cleaning solvent (enzymatic or neutral pH detergent, e.g., liquinox, MetriZyme) by
using distilled or softened water in accordance with the operator’s manual provided by the
manufacturer.
4. Detach all the detachable parts of the needle-guided bracket and immerse the needle-guided
bracket and all its parts fully in the cleaning solvent for at least 1 minute or a period specified
by the manufacturer.
5. Immerse the needle-guided bracket and all its parts fully in the cleaning solvent. Wipe and
wash the surface and connecting parts of the needle-guided bracket gently by using a soft
brush until no dirt is visible. Place the needle-guided bracket inside an ultrasonic cleaner and
perform ultrasonic cleaning for 3–5 minutes.
6. Rinse the needle-guided bracket thoroughly by using a large amount of distilled or softened
water (about 2 gallons) at room temperature for about 30 s to remove the residual dirt and
cleaning solvent. Repeat the operation twice.
7. Wipe away the water on the needle-guided bracket by using a piece of disposable lint-free soft
cloth.
8. Inspect the needle-guided bracket. If visible dirt still exists, repeat the preceding steps to wash
the bracket until it is all clean.

Sterilization with a sterilant

Perform the following procedure:
1. Wear a pair of gloves to prevent infection.
2. Clean thoroughly in accordance with the cleaning procedure before sterilization.

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 16 Probes and Biopsy

3. Prepare a sterilant by using sterile distilled water when necessary.

Table 16-5 Recommended sterilization solution

Chemical name Trade name Procedures
Glutaraldehyde (2.4%) Cidex Activated Dialdehyde Refer to the instructions
Solution provided by the solution
(applicable for FDA region manufacturer for details.
only)
22% Hydrogen Peroxide Minncare liquid disinfectant Refer to the instructions
4.5% Peroxyacetic Acid (applicable for Canada only) provided by the solution
manufacturer for details.
Glutaraldehyde (2.6%) Metricide Refer to the instructions
provided by the solution
manufacturer for details.

4. Immerse the needle-guided bracket fully in the sterilant and shake the bracket appropriately to
remove any bubbles on the surface. Use a syringe to draw an appropriate amount of sterilant
and inject the sterilant into the hole to remove the bubbles inside the hole if necessary.
For details about the immersion duration, see the operator’s manual provided by the
manufacturer.
5. After sterilization, wash the needle-guided bracket thoroughly by using a large amount of
sterile distilled water (about 2 gallons) at room temperature for about 30 s to remove the
residual sterilant. Repeat the operation twice.
6. Dry the needle-guided bracket by using a piece of sterile disposable lint-free soft cloth.
7. Store the needle-guided bracket in a cool, clean and dry environment.

High-pressure steam sterilization

Perform the following procedure:
1. Wear a pair of gloves to prevent infection.
2. Clean thoroughly in accordance with the cleaning procedure before sterilization.
3. Package the needle-guided bracket in accordance with the sterilization requirements of
surgical instruments.
4. Place the packaged needle-guided bracket inside a high-temperature steam sterilizer and
perform sterilization. The sterilization parameters are 121 °C and 30 minutes for a gravity
displacement steam sterilizer and are 132 °C and 4 minutes for a dynamic-air-removal steam
sterilizer.
5. Take out the sterilization package after sterilization and dry it in an oven at 60 °C for 20
minutes to 30 minutes.
Keep the sterilization package together with other sterilized surgical instruments in a sterile
item storage area.
High-pressure steam sterilization is preferred for the metal guided brackets. And the sterilizer and
accessories should be cleared by FDA for the intended sterilization cycle.
Perform the following procedure:
1. Wear a pair of gloves to prevent infection.
2. Clean thoroughly in accordance with the cleaning procedure before sterilization.
3. Package the needle-guided bracket in accordance with the sterilization requirements of
surgical instruments using the sterilization wrap or pouch cleared by FDA.

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4. Place the packaged needle-guided bracket inside a high-temperature steam sterilizer and
perform sterilization. The sterilization parameters are 121 °C and 30 minutes for a gravity
displacement steam sterilizer and are 132 °C and 4 minutes for a dynamic-air-removal steam
sterilizer.
5. Take out the sterilization package after sterilization and dry it in an oven at 60 °C for 20
minutes to 30 minutes.
Keep the sterilization package together with other sterilized surgical instruments in a sterile
item storage area.

16.2.6 Storage and Transportation

• Do not use the carrying case for storing the needle-guided bracket. If the carrying case is used
for storage, it may become a source of infection.
• Between examinations, keep the needle-guided bracket in a sterile environment.
• If the needle-guided bracket is sent to your MINDRAY representative for repair, be sure to
disinfect or sterilize it and keep it in the carrying case to prevent infection.
• Sterilize the carrying case as necessary.
• Store or transport the needle-guided bracket under the following ambient conditions:
– Ambient temperature: -20 °C to 55 °C
– Relative humidity: 20% to 85% (no condensation)

16.2.7 Disposal
Be sure to sterilize the needle-guided bracket before disposing of it.
Contact your MINDRAY representative when disposing of this device.

16.3 Middle Line

Middle Line helps to locate and observe the focus point of lithotripsy wave during lithotripsy
treatment. By means of providing information for the lithotripsy machine as well as a tool for
watching the procedure of lithotripsy in real-time, you can adjust the intension and frequency of the
lithotripsy wave through lithotripsy machine.

NOTE:
This function in the ultrasound system is for lesion (stone) location and observation only. For
details, please refer to lithotripsy machine accompanying manuals.

Tap [Biopsy] > [Middle Line] or press the user-defined key for “Middle Line” to turn on the
function.
• The middle line is a vertical dotted line located in the middle of the screen, the position and
direction of which cannot be changed.
• There is a mark icon of “×” located on the middle line which can be moved up and down along
the line by using the trackball/trackpad.
• To use the Middle Line function of the ultrasound system:
a. Use the trackball/trackpad to change the mark position and by adjusting lithotripsy
machine tools or patient posture to locate the stone center at the mark.
b. Read the depth of the mark by observing the depth caliper on the screen.
c. After the stone is located, refer to lithotripsy machine manuals to perform the lithotripsy.
• The depth of the mark is displayed in the image parameter area of the screen.

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16.4 eSpacial Navi

The eSpacial Navi function builds up the connection between the ultrasound system and the
processed needles. The needle position appears on the image in real time. Meanwhile, the virtual
needle mark guides the needle path on the ultrasound image. Based on the magnetic induction
technology, the eSpacial Navi function aids in and enhance the ultrasound needle guidance.

WARNING
• Ultrasound images should be referenced during the whole process of
needle guidance.
• The magnetizer should be used with the needle cap. Disinfect the
magnetizer after use.
• The needle cap is a sterile, single use device. To maintain procedural
sterility, it is important that the needle cap is isolated from non-sterile
objects.

CAUTION
• Keep the magnetizer away from any device that is sensitive to magnetic
fields. Never place or hold the magnetizer within 1 m of the probe.
• The eSpacial Navi system supports only the needle types listed on the
needle list. For details, see “16.4.1 Interface”.
• Keep the L11-3VNs and L12-3VNs away from the source of disturbance,
such as metal objects and magnetized objects. Do not use or store L11-
3VNs and L12-3VNs in the vicinity of strong electric or magnetic fields.

NOTE:
• When used under optimal operating conditions by an experienced medical professional, the
eSpacial Navi system can achieve precision as high as ±2.4 mm.
• Place the magnetizer in the proper position to prevent the magnetizer from falling off or
becoming damaged.
• DO NOT make the magnetizer overheated (more than 50 °C) during cleaning and
disinfections. High temperature may cause the magnetizer to become deformed or damaged.

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16.4.1 Interface
In Plane Needle Guidance GUI

2
8

3
7

4 5

1 Alignment indicator (plan view)

2 Filed strength
3 Maximum depth at which the needle can be detected
4 Selected needle type
5 Scale of guideline (5 mm/scale)
6 Needle guidance trajectory
7 Needle tip position in the ultrasound plane
8 Needle position in the ultrasound plane

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Out of Plane Needle Guidance GUI

1 8

2
7

3 6

1 Alignment indicator (plan view)

2 Filed strength
3 Maximum depth at which the needle can be detected
4 Selected needle type
5 Scale of guideline (5 mm/scale)
6 Projection position of the needle guidance trajectory in the ultrasound plane
7 Position at which the needle cross the ultrasound plane
8 Needle projection position in the ultrasound plane

16.4.2 Preset
eSpacial Navi Needle Menu
Select [eSpacial Navi] > [eS.Navi Needle] to enter the “eS.Navi Needle” menu.
Controls are as shown in Table 16-6.

Table 16-6 eSpacial Navi Needle settings

Item Description
Needle Select the desired needle from the drop-down list.
You can set the most frequently used needle to a favorite one.
Display Favourite Only After it is ticked, only the favorite needles are displayed on the needles
list.
Auto Optimize After it is ticked, the system adjusts focus position automatically
according to the position of the needle tip, and enable or disable
ExFOV function.

eS.Navi Settings Menu

Tap [eSpacial Navi] > [eS.Navi Settings] to enter the “eS.Navi Settings” menu, and tap the items to
be displayed on the screen.

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16.4.3 Preparation Before Needle Guidance

NOTE:
Before and during calibration, keep the probe away from the magnetic sources, such as metal
objects, electrical motors, switching power supplies, nerve stimulators and similar medical devices.

Perform the following procedure:

1. Scan the target tissue and adjust the image parameters.
2. Check the field strength to ensure that the filed strength indicator is . If the filed strength
is low, hold the probe and tap [Calibrate] on “eS.Navi Needle” menu. Do not move the probe
during the calibration.

Indicator Colors Description

Green Low magnetic interference: appropriate for needle guidance.
Yellow Medium magnetic interference: be cautious for needle guidance.
Red High magnetic interference: do not perform needle guidance.

3. Magnetize a needle cap.

a. Place an appropriate sterile needle cap (length: 3.5cm to 4.5cm, diameter < 7 mm, with
bottom closed) into the magnetizer.

b. Introduce a needle into the cap, and ensure that the needle tip contacts the bottom of the
needle cap.
If the needle cap associated with the needle does not meet the requirements, you are
recommended to use BBraunSterican <35 mm needles cap or B&D Microlance <35 mm
needles cap.

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c. Hold the needle for 1 or 2 seconds and then withdraw it quickly from the magnetizer.

16.4.4 Procedure
NOTE:
• The Pan Zoom function is not supported on eSpacial Navi mode.
• Do not freeze the ultrasound image during the procedure. Otherwise, biopsy guidance
information will disappear.
• When the insertion angle of a needle relative to the skin surface exceeds 60°, is displayed
on screen to notify users to adjust the angle. After the angle is smaller than 60°, disappears.

Perform the following procedure:

1. Hold the probe stably and put the needle close to the probe for connection. After the needle and
probe are successfully connected, the system automatically calculate the maximum depth at
which the needle can be detected in real time, and display the depth value in the touch screen.
When the actual depth is greater than the maximum value, the needle guidance information
disappears temporally.
2. Adjust the needle position and angle to define the position for inserting the needle.
Pay attention to the field strength during the needle guidance process.

16.4.5 Magnetizer Cleaning and Disinfection

After use, clean and disinfect the magnetizer as required. Failure to do so may result in the
magnetizer becoming sources of infection.

CAUTION
• When performing cleaning and disinfection of the magnetizer to prevent
infection, wear sterile gloves.
• After disinfection, rinse the magnetizer thoroughly with sterile water to
remove all chemical residues.
• No cleaning and disinfecting may result in the magnetizer becoming a
source of infection.
• Please follow the disinfectant manufacturer's manual for performing
cleaning and disinfection, including preparing sterile water and cleaning
and disinfection time.

NOTE:
• Please refer to the instructions provided by the manufacturer of the disinfectant for details.
• The magnetizer can be disinfected using the compatible disinfectants at least 500 times.

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Compatible disinfectants for the magnetizer are shown in Table 16-7.

Table 16-7 Compatible disinfectants

Trade Name Manufacturer Chemical Name Procedures
Surfa’safe Anios Laboratoires didecyldimethylammonium chloride Sprays, fungicidal
1.4mg/g; in 20 min
polyhexamethylene biguanide T.B in 15 min
hydrochloride 0.96mg/g
Sani-Cloth® Plus PDI n-Alkyl dimethyl benzyl ammonium Wipes, 3 min
chloride;
n-Alkyl ethylbenzyl ammonium
chloride
OxivirTM/MC Tb Diversey 0.5% hydrogen peroxide Sprays, 10 min
CLEANISEPT® DR.SCHUMACHE 0.25g Wipes, 2 min
WIPES R GMBH didecyldimethylammoniumchloride;
0.5g quaternary ammonium
compounds; benzyl-C12-16-
alkyldimethyl-; chlorides
mikrozid® AF SCHÜLKE 25% ethanol; 35% propan-1-ol Wipes, 15 min
Wipes Jumbo
IODOCLEAN Anios Laboratoires sodium thiosulfate and excipients Sprays, 5 ~ 15
min
tristel duo TRISTEL chlorine dioxide Sprays, 1 min
SOLUTIONS
75% alcohol / alcohol Solution, 3 min
iodophor / / Solution, 3 min

Cleaning
Perform the following procedure:
1. Wear sterile gloves to prevent infection.
2. Wash the magnetizer with clean water or soapy water to remove all the foreign matters, or,
wipe the magnetizer with a soft ethyl carbamate sponge.
Avoid using a brush, because it may damage the magnetizer.
3. Dry the magnetizer using a sterile cloth or gauze after rinsing. Do not dry the magnetizer by
heating it.

Disinfecting with Sprays or Wipes

CAUTION
Use protective eyewear when disinfecting using sprays.

Perform the following procedure:

1. Wear sterile gloves to prevent infection.
2. After you have finished cleaning, wipe or spray the magnetizer with a disinfectant.
Follow the disinfectant manufacturer’s recommended contact time and mode.

Operator’s Manual 16 - 51
 16 Probes and Biopsy

3. Remove any residue with a water-moistened soft cloth on the magnetizer.

4. Wipe off water on the magnetizer using sterile cloth or gauze after washing.

Disinfecting by Immersion
Perform the following procedure:
1. Wear sterile gloves to prevent infection.
2. Clean the magnetizer before disinfecting it. MINDRAY recommends the compatible solutions
to disinfect the magnetizer.
– Refer to the instructions provided by the chemical manufacturer concerning concentration
of the disinfectant solution, method of disinfection and dilution and cautions during use.
– Soak the magnetizer into the disinfectant solution for the shortest time the manufacturer
recommends.
– Follow local regulations when selecting and using the disinfectant.
3. Rinse the magnetizer with plenty of water (about 2 gallons) for at least 1 minute to remove all
chemical residues on it. Or, follow the rinsing method recommended by the disinfectant
manufacturer to rinse the magnetizer.
4. Wipe off the water on the magnetizer with sterile cloth or gauze after rinsing it. Do not dry the
magnetizer by heating.

16.4.6 Storage and Transportation

When all examinations for the day have been completed, confirm that the magnetizer is in good
condition. After disinfecting the magnetizer, confirm that the magnetizer is in good condition and
stored in a suitable place.
• To prevent the magnetizer from being damaged, DO NOT store it where it may be exposed to:
– Direct sunlight
– Sudden changes in temperature
– Dust
– Excessive vibration
– Heat generators
• Store and transport the magnetizer in the ambient temperature range of -40 °C to 50 °C.
• Sterilize the carrying case as necessary.

16.4.7 Disposal
Be sure to disinfect the magnetizer before disposing of it.
Contact your MINDRAY representative when disposing of this device.

16 - 52 Operator’s Manual
17 DVR Recording

NOTE:
• Strictly observe the procedures described here to perform the recording and replaying
operations; otherwise it may result in data loss or system malfunction.
• Set the PAL or NTSC in the setup and this shall be consistent with that in the DVR.
• Accidental exposure to strong electromagnetic fields or mishandling of the video cassette may
result in image and data loss, so check if the recording is successful as soon as possible.
Mindray is not responsible for any data loss.

The system provides built-in DVR recording function. You can use the DVR to record and replay
videos and audios that can be stored in DVD disc or hard disc.
The recorded video is AVI format; you can save it in the hard disk drive, burn to the DVD or export
to the USB disk.
When the built-in DVR is in normal status, the displays at the lower right corner of the screen.

17.1 Start Recording

After recording, the system will save the recording file automatically, you can select to save in local
disk, U disk or optical disk.
Perform the following procedure:
1. Perform ultrasound exams, select appropriate views and adjust parameters to prepare for
recording.
2. Click to open the dialog box and select desired recording type: Hard disk/USB/CDRO.
3. Click [Close] to enter recording status.
4. Press the user-defined key for “DVR” and click [OK] to start recording, and the DVR icon
displays as in recording status.
During the recording process, you can perform imaging mode switching, comments adding,
body mark adding and measurements.
5. Press the user-defined key for “DVR” again to stop recording, the DVR icon in the lower right
corner turns into data transfer status .
– If USB/CDROM is selected, the system sends the recorded file to the target storage media
(USB disk or DVD optical disk drive) in the meantime.
– If “Hard disk” is selected, the system saves the file to the path: D:\Monet\DVR.
In the patient task management screen, click [Media Storage Task] tab to check transferring
status.

17.2 Send Image

The system also supports exporting recorded images that are saved in the local disk.

Operator’s Manual 17 - 1
 17 DVR Recording

Perform the following procedure:

1. Click to open the dialog box, and click [Local Video Management] to enter the managing
dialog box.
Click [Rename] to rename the video file.
2. Select the destination and the target file, click [Send] to send the file to the selected path.
During sending progress, the icon displays as .

17.3 DVR Video Replay

You can replay the video and audio record.

17.3.1 Replay on PC
Connect the USB disk or optical disk with the file to the PC, open the file directly.

17.3.2 Replay on the ultrasound system

Perform the following procedure:
1. Click to open the dialog box and select desired playing type: Hard disk/USB/CDROM.
2. Click [Play] to open the dialog box.
3. Select the path and name for the file and then click [OK] to replay the file, or double-click the
file name directly.

17 - 2 Operator’s Manual
18 System Maintenance

Routine system maintenance shall be carried out by the user. System maintenance after the
warranty has expired is the full responsibility of the owner/operator.
The responsibility for maintenance and management of the product after delivery resides with the
customer who has purchased the product.
If you have any questions, please contact Mindray Customer Service Department or sales
representative.

WARNING
• Only an authorized Mindray service engineer can perform maintenance not
specified in this operator’s manual.
• For the sake of the system performance and safety, you should perform
periodical checks for the system.

18.1 Daily Maintenance

You are responsible for daily maintenance.

18.1.1 Cleaning the System

WARNING
• Before cleaning the system, be sure to turn off the power and disconnect
the power cord from the outlet. Cleaning the system while the power is “On”
may result in electric shock.
Especially, the touch screen and control panel of the system equipped with
trackpad can be cleaned on power-on status: tap > bar in the left side of the
touch screen to enter the Exam Main Menu screen and select to lock
the system for 10 seconds while the power is “On”; before cleaning other
parts of the system, be sure to turn off the power and disconnect the power
cord from the outlet; or, it may result in electric shock while the power is
“On”.
• DO NOT directly spray solution onto the monitor, system control panel or
hard surfaces that is under pressure or pumped. Ingress fluid leakage into
the monitor or system can damage the monitor or system, causing possible
electric shock or system failure.

Operator’s Manual 18 - 1
 18 System Maintenance

CAUTION
Do not spill water or other liquid into the system while you perform the cleaning.
Otherwise it may result in malfunction or electric shock.

NOTE:
• DO NOT use hydrocarbon glass cleaner or cleaner for OA (Office Automation) equipment to
clean the monitor. These substances may cause deterioration of the monitor.
• Please clean the control panel periodically, otherwise the button may be blocked by dirt and the
system will be buzzing while the button makes no response.

Cleaning probes
Tools: mild soapy water, dry soft cloth, soft brush
Method:
1. Wipe out the dust attached to surface of probe head, connector and cable.
2. Use soft brush to brush the dust inside probe connector gently.
3. Remained stain or dust attached to surface of cable or surface of connector should be washed
out by cloth with a little soapy water, and then air-dry.

NOTE:
Don’t use cloth with water to clean the probe connector.

Cleaning holders
Tools: soft dry cloth, soapy water, soft brush.
Remaining stains should be wiped away using a cloth with clean or soapy water and the surface left
to air dry.
Perform the following procedure:
1. Use a soft dry cloth to wipe away dust attached to the inside, outside and gaps in the probe
holder. Use a soft brush to brush away dust or stains from the small intra-cavity probe holder or
its gap.
2. Remaining stains on the inside and outside of the holder should be wiped away using a cloth
with a little soapy water and then air dried.

Cleaning the monitor and the touch screen

Tool: soft dry cloth, soapy water
The surfaces of the monitor and touch screen should be cleaned with a soft dry cloth. Remaining
stains should be wiped away using a cloth with a little soapy water and then air dried.

Cleaning the main panel

Tools: soft dry cloth, soapy water
1. Use a soft dry cloth to clean the surface of the control panel.
If the control panel is dirty, moisten the soft cloth with a little mild soapy water and wipe away
any stains.
2. Use another soft dry cloth to remove any moisture and allow all hard surfaces to completely air
dry.

18 - 2 Operator’s Manual
 18 System Maintenance

If the control panel is difficult to clean, disassemble the key caps first and then clean it with
mild soapy water.

Cleaning the trackball

Tools: paper, dry cloth, mild soapy water
For the stable performance of the system, you should perform periodical cleaning for the trackball.
A dumb cursor may be resulted from dirt inside the trackball.
Perform the following procedure:
1. Disassembling:

Clamp ring Optical trackball

Rotate the trackball clamp ring anticlockwise. When the clamping ring lifts, remove the
clamping ring and trackball. You can draw out the ball with the help of adhesive tape.
2. Cleaning:

Dust excluder

Small ball (3) Lens

Waterspout

Clean the lens slightly using the tissue until there is no foreign matter. Then clean the other
parts and the dust excluder. Make sure to exert force properly when clean the small ball,
otherwise, the small ball may drop down.
When liquid is spray onto the trackball area, most of the liquid can be discharged through the
waterspout, besides, you can dry the leaving water using the tissue or cloth.
3. Installing:

Put back the ball, align the buckle with gap of the front cover, press the clamp ring with both
hands and rotate it clockwise to click the buckle. At this moment, the clamp ring cannot be
moved any further, it indicates that the clamp ring clicks in position.

Operator’s Manual 18 - 3
 18 System Maintenance

Cleaning the dust-proof covers

CAUTION
Please clean all dust-proof covers of the system periodically (1 time per
month); otherwise, system damage may result. Cleaning times can be
increased when the system is used in the open air or somewhere dust is more.

Tool: soft brush

Method:
Disassemble dust-proof cover before cleaning.

18.1.2 Disinfecting the Main Unit

For details about disinfecting the main unit, please refer to the Cleaning, Disinfection &
Sterilization Guide.

18.1.3 Cleaning the peripherals

Do the cleaning maintenance according to your actual peripheral configuration; items which are not
configured can be skipped.

Content Description
Color and B/W video First wipe off dust or stain attached to the cover of printer with soft dry
printer cloth, then clean the inside of printer. Be sure to do the cleaning
maintenance according to the operation manual if necessary.
Graph / text printer First wipe off dust or stain attached to the cover of printer with soft dry
cloth, then clean the inside of printer. Be sure to do the cleaning
maintenance according to the operation manual if necessary.
Footswitch Use soft dry cloth with a little mild soap water to wipe off the dust or
stain attached to the pedals or cable of foot switch.
Barcode reader First use soft dry cloth to wipe off dust attached to glass panel of the
reader, then the dust or strain attached to cable and bracket.

18 - 4 Operator’s Manual
 18 System Maintenance

18.1.4 Checking the Probe

• Visually check to confirm that there are no cracks or expansion of the probe head.
• Visually check to confirm that there is no deterioration or erosion of the probe cable.
• Visually check to confirm that none of the connector pins are bent, destroyed or falling off.

18.1.5 Checking the Power Cable and Plug

Visually check to confirm that there are no wrinkles, cracks or deterioration, and no cracks or
expansion on the surface of the adapter.
Manually check to confirm that there is no looseness or rupture. The connection of the plug is
reliable.

18.1.6 Checking Appearance

Check if there are any cracks in the covers:
• Ultrasound system covers.
• Probe appearance.
• External appearance of the ECG lead.

18.1.7 System Hard Drive Backup

To prevent deterioration or loss of data stored in the system hard drive (including patient info data,
preset data, etc.), create a backup copy of the hard drive at regular intervals.

18.2 Troubleshooting
If any persistent system malfunction is experienced, e.g., an onscreen error message, blank imaging
screen, absent menus, see the table below. If the failure cannot be resolved, contact the Mindray
Customer Service Department or a sales representative.

No. Failure Cause Measure

1. The power indicator The interval between turning off Turn off the system and wait at
of the monitor is lit and restarting the system is too least 1 minute, then restart the
up, but the image is short - wait at least 20 seconds. system.
blank.
The monitor brightness or Adjust the monitor brightness
contrast may be improperly set. and contrast back to the factory
defaults.
2. The monitor displays The transmission power, overall Adjust the transmission power,
the characters and gain or TGC controls are gain or TGC control.
menus but no images. improperly set.
Check that a probe is connected Ensure proper probe connection.
and/or fully connected.
The system is in freeze status. Unfreeze the image.

Operator’s Manual 18 - 5
 18 System Maintenance

No. Failure Cause Measure

3. The image quality is The exam mode is incorrect. Select an appropriate exam
degraded mode.
The image post-processing Adjust the image post-processing
settings are incorrect. settings or reset post-processing
to the default values.
The image presets are Reset the factory default presets.
inappropriate.
4. The button does not There is dirt blocking the button. Check the control panel for the
respond and the blocked button and press it
system is buzzing several times to release it.
Clean the button.

18 - 6 Operator’s Manual
A Barcode Reader

The product supports two kinds of readers for logging data as patient ID. For details of the JADAK
or Honeywell barcode readers, please refer to the accompanying manuals.
The laser transmitted by SYMBOL LS2208 is Class 2 laser.
SYMBOL DS4308 is classified as “EXEMPT RISK GROUP” according to IEC 62471:2006 and
EN 62471:2008.

WARNING
• Class 2 laser adopts low power, visible LED. DO NOT stare into beam
because of unknown hazards of transient radiation provided by class 2
laser.
• DO NOT stare into beam emitted by SYMBOL DS4308 for more than 10 s.

CAUTION
Ensure the information acquired by barcode reader is consistent with the actual
information.

TIP:
The reader does not support decoding of Multi-language.

A.1 1-D Barcode Reader

There are 2 operation modes for 1-D barcode readers:
• Hand-held mode: press the trigger to decode.
• Hands-free mode: seat the reader in the stand to enter the mode, the reader decodes
automatically.

Operator’s Manual A-1

A Barcode Reader

1 LED • Green: A barcode was successfully decoded.

• Red: A data transmission error or reader malfunction occurred.
2 Scan window Scan the barcode.
3 Trigger Press to decode.

A.1.1 Setting Up the Reader (Take LS2208 as an example)

1 Cable interface port

2 Interface cable modular connector

Perform the following procedure:

1. Plug the interface cable modular connector into the cable interface port on the bottom of the
reader handle, and ensure the connector is properly secured.
2. Connect the other end of the interface cable to the host.

A.1.2 Setting
The reader has factory settings; please refer to A.4 for details.
The reader supports some user-defined functions as introduced below.

A-2 Operator’s Manual

 A Barcode Reader

For more details, please contact the SYMBOL reader agents or Mindray Customer Service
Department.

Volume setting
Scan the following barcode to set the volume parameter.
• Low Volume:

• Medium Volume:

• High Volume:

Code 93 and codebar scanning

• To enable or disable Code 93, scan the appropriate barcode below.

• To enable Codebar, scan the appropriate barcode below.

Code 39 full ASCII scanning

Code 39 Full ASCII is a variant of Code 39 which pairs characters to encode the full ASCII
character set. To enable or disable Code 39 Full ASCII, scan the appropriate barcode below.

Operator’s Manual A-3

A Barcode Reader

I 2 of 5 symbols setting:

Select this option to decode only I 2 of 5 symbols containing a selected length. Select the length
using the numeric barcodes below. For example, to decode only I 2 of 5 symbols with 8 characters,
scan I 2 of 5 - One Discrete Length, then scan 0 followed by 8.

A.1.3 Scanning in Hand-Held Mode

Perform the following procedure:
1. Ensure all connections are secure.
2. Aim the reader at the barcode. Press the trigger.
Ensure the scan line crosses every bar and space of the symbol, see the figure below.

3. Upon successful decode, the reader beeps and the LED turns green.

A-4 Operator’s Manual

 A Barcode Reader

Do not hold the reader directly over the barcode. Laser light reflecting directly back into the
reader from the barcode is known as specular reflection. This specular reflection can make
decoding difficult. You can tilt the reader up to 55° forward or back and achieve a successful
decode.

A.1.4 Scanning in Hands-Free Mode

Assembling the Intellistand

1 One piece scanner “cup” with flexible neck

Operator’s Manual A-5

A Barcode Reader

2 Flat areas
3 Stand base
4 Wingnut

Perform the following procedure:

1. Unscrew the wingnut from the bottom of the one piece scanner “cup”.
2. Fit the bottom of the neck piece into the opening on the top of the stand base.
3. Tighten the wingnut underneath the base to secure the cup and neck piece to the base.
Before tightening the wingnut under the base, ensure that the flat areas on the flexible neck fit
securely in the grooves in the base.
4. Bend the neck to the desired position for scanning.

Mounting the Stand (optional)

You can attach the base of the reader’s stand to a flat surface using two screws or double-sided tape
(not provided).

1 Two screw-mount holes For Screw Mount, follow the steps below:
1. Position the assembled base on a flat surface.
2. Screw one #10 wood screw into each screw-mount
hole until the base of the stand is secure
2 Double-side tap areas For Tape Mount, follow the steps below:
(3 places, dimensions: 1”×2”) 1. Peel the paper liner off one side of each piece of
tape and place the sticky surface over each of the
three rectangular tape holders.
2. Peel the paper liner off the exposed sides of each
piece of tape and press the stand on a flat surface
until it is secure.

Perform Scanning in Hands-Free Mode

When the reader is seated in the scanner cup, the reader’s built-in sensor places the reader in hands-
free mode. When you remove the reader from the stand it operates in its normal hand-held mode.

A-6 Operator’s Manual

 A Barcode Reader

A.2 2D Barcode Reader (Take DS4308 as an

example)
The 2-D barcode reader supports hand-held operation mode.
Hand-held mode: press the trigger to decode.

A.2.1 Overview

1 LED • Green: A barcode was successfully decoded.

• Red: A data transmission error or reader malfunction occurred.
2 Scan window Scan the barcode.
3 Trigger Press to decode.

Operator’s Manual A-7

A Barcode Reader

A.2.2 Setting Up the Digital Imager Reader

Installing the Interface Cable

Perform the following procedure:

1. Plug the interface cable modular connector into the cable interface port on the bottom of the
reader handle and ensure the connector is properly secure.
2. Connect the other end of the interface cable to the host.

Removing the Interface Cable

Perform the following procedure:

1. Using the tip of a screwdriver or some other tools with a sharp head, depress the cable’s
modular connector clip.
2. Carefully slide out the cable.

A.2.3 Setting
The reader has factory settings, for details see “A.4 Parameter Defaults”.
The reader supports some user-defined functions as introduced below.
For more details, please contact the SYMBOL reader agents or Mindray Customer Service
Department.

A-8 Operator’s Manual

 A Barcode Reader

Volume setting
Scan the following barcode to set the volume parameter.
• Low Volume

• Medium Volume

• High Volume

Code 93 and codabar setting

• To enable Code 93, scan the appropriate barcode below.

• To enable Codabar, scan the appropriate barcode below

Code 39 full ASCII setting

Code 39 Full ASCII is a variant of Code 39 which pairs characters to encode the full ASCII
character set. To enable or disable Code 39 Full ASCII, scan the appropriate barcode below.

Operator’s Manual A-9

 A Barcode Reader

I 2 of 5 symbols setting

Select this option to decode only I 2 of 5 symbols containing a selected length. Select the length
using the numeric barcodes below. For example, to decode only I 2 of 5 symbols with 8 characters,
scan I 2 of 5 - One Discrete Length, then scan 0 followed by 8.

A.2.4 Scanning in Hand-Held Mode

Perform the following procedure:
1. Ensure all connections are secure (see the appropriate host chapter.)
2. Aim the digital imager reader at the barcode.

A - 10 Operator’s Manual
 A Barcode Reader

3. When the digital imager reader senses movement, in its default Auto Aim trigger mode, it
projects a red LED dot which allows positioning the barcode within the field of view.

If necessary, the digital imager reader turns on its red LEDs to illuminate the target barcode.
4. Center the symbol. Be sure the entire symbol is within the rectangular area formed by the
illumination LEDs.

5. Hold the trigger until the digital imager reader beeps, indicating the barcode is successfully
decoded.
Steps 2 - 4 above may be required to repeat on poor quality or difficult barcodes.
The aiming pattern is smaller when the digital imager reader is closer to the symbol and larger
when it is farther from the symbol. Scan symbols with smaller bars or elements (mil size)
closer to the digital imager reader, and those with larger bars or elements (mil size) farther
from the digital imager reader.
The digital imager reader can also read a barcode presented within the aiming dot not centered.
The top examples in show acceptable aiming options, while the bottom examples cannot be
decoded.

Operator’s Manual A - 11
 A Barcode Reader

A.3 Maintenance
Cleaning the exit window is the only maintenance required. A dirty window can affect scanning
accuracy.
• Do not allow any abrasive material to touch the window.
• Remove any dirt particles with a damp cloth.
• Wipe the window using a tissue moistened with ammonia/water.
• Do not spray water or other cleaning liquids directly into the window.

A.4 Parameter Defaults

Refer to the following table for parameter defaults of LS2208 and DS4308.

Parameter Defaults Parameter Defaults

1-D Symbologies Interleaved 2 of 5 (ITF)
UPC/EAN Interleaved 2 of 5 (ITF) Enable Enable
UPC-A Enable Set Lengths for I 2 of 5 14
UPC-E Enable I 2 of 5 Check Digit Verification Disable
UPC-E1 Disable Transmit I 2 of 5 Check Digit Disable
EAN-8/JAN 8 Enable Convert I 2 of 5 to EAN 13 Disable
EAN-13/JAN 13 Enable Codabar (NW - 7)
Bookland EAN Disable Codabar Enable
Decode UPC/EAN/JAN Ignore Set Lengths for Codabar 5 to 55
Supplementals (2and 5 digits)
UPC/EAN/JAN 10 CLSI Editing Disable
Supplemental Redundancy
Transmit UPC-A Check Digit Enable NOTIS Editing Disable
Transmit UPC-E Check Digit Enable
Transmit UPC-E1 Check Enable 2-D Symbologies
Digit
UPC-A Preamble System Character PDF417 Enable
UPC-E Preamble System Character MicroPDF417 Disable
UPC-E1 Preamble System Character Code 128 Emulation Disable
Convert UPC-E to A Disable Data Matrix Enable
Convert UPC-E1 to A Disable Maxicode Enable

A - 12 Operator’s Manual
 A Barcode Reader

Parameter Defaults Parameter Defaults

EAN-8/JAN-8 Extend Disable QR Code Enable
UCC Coupon Extended Code Disable
Code 128
Code 128 Enable
UCC/EAN-128 Enable
ISBT 128 Enable
Code 39
Code 39 Enable
Trioptic Code 39 Disable
Convert Code 39 to Code 32 Disable
(Italian Pharmacy Code)
Code 32 Prefix Disable
Set Length(s) for Code 39 2 to 55
Code 39 Check Digit Disable
Verification
Transmit Code 39 Check Disable
Digit
Code 39 Full ASCII Disable
Conversion
Buffer Code 39 Disable
Code 93
Code 93 Enable
Set Length(s) for Code 93 4 to 55

Operator’s Manual A - 13
This page intentionally left blank.
B Trolley and Accessories

WARNING
• DO NOT connect the trolley to the outlets with the same circuit breakers
and fuses that control the current to devices such as life-support systems. If
the trolley or the system malfunctions and generates over-current, or when
there is an instantaneous current at power ON, the circuit breakers and
fuses of the building’s supply circuit may be tripped.
• When you connect another device to the trolley, you should use the
equipotential wire to connect each of equipotential terminals; otherwise
electric shock may result.
• Be sure to connect the equipotential wire before inserting the power plug
into the receptacle; be sure to remove the power plug from the receptacle
before disconnecting the equipotential wire; otherwise electric shock may
result.
• Connect the earth cable before powering ON. Disconnect the earth cable
after powering OFF. Otherwise, electric shock may result.

CAUTION
• Maximum output power of the outlet in the trolley is 240 VA.
• When moving the trolley with mounted system, please take care of the
connector of the power adapter in case of damage.
• DO NOT insert fingers into the gap next to the plug in case of injury.

B.1 Accessories
TIP:
The supplied accessories are depending on the actual purchased order.

MT3 Trolley
• Power cord
• Probe holder (4D probe holder, big probe holder)
• Cover grounding cable
• Probe extension module or Probe extend module panel
• Auxiliary output cable
• Printer bracket

Operator’s Manual B-1

B Trolley and Accessories

MT2 Trolley
• Probe extension module
• Printer bracket
• Probe holder (4D probe holder, big probe holder)

B.2 Introduction of Each Unit

MT3 Trolley
Figure B-1 Overview of the Trolley

13 14
12
1
11 15
2
10 16
3
9
8

7
6

No. Item Description

1. Trolley handle Used for ascending/descending the trolley or moving the
trolley.
2. Probe holder Used for placing probes temporarily.
3. Storage box Used for placing report or other stuff.
4. Caster Used for securing or moving the system.
5. Retractable cable AC power supply cable.
6. Power indicator Lights at AC supply.
7. Power outlet Supplies the power for peripheral devices.
8. Power adapter bracket Used for placing the power adapter.
9. Lifting column Used for adjusting the height of operation panel.
10. Probe extension module Used for extend ports for connecting probes (optional).
11. Protective handle Used for moving the trolley and protecting the trolley from
crash during moving.

B-2 Operator’s Manual

 B Trolley and Accessories

No. Item Description

12. Equipotential terminal Used for equipotential connection, balancing the
protective earth potentials between the system and other
electrical equipment.
13. Anti-theft lock Used for releasing the main unit from the trolley.
14. Main unit tray Used for placing and fixing the main unit. You can remove
the tray and install the U-Bank (purchased separately)
instead.
NOTE:
Keep the main unit tray carefully for future use after it
is removed from the trolley. Reinstall the main unit tray
to the trolley if the U-Bank has been removed from the
trolley.
15. Height lever Used for adjusting the height of the stand.
16. Tray release lever (located Used for removing the main unit tray.
on the bottom of the handle)

MT2 Trolley
Figure B-2 Overview of the Trolley

11
1
2

3 10

4
9
5

Operator’s Manual B-3

B Trolley and Accessories

No. Item Description

1. Main unit tray Used for placing and fixing the main unit. You can remove
the tray and install the U-Bank (purchased separately)
instead.
NOTE:
Keep the main unit tray carefully for future use after it
is removed from the trolley. Reinstall the main unit tray
to the trolley if the U-Bank has been removed from the
trolley.
2. Probe holder Used for placing probes temporarily.
3. Trolley handle Used for moving the trolley.
4. Tray release lever (located Used for removing the main unit tray.
on the bottom of the handle)
5. Cable hook Manage cables.
6. Storage box Used for placing report or other stuff.
7. Caster Used for securing or moving the system.
8. Printer bracket Used for placing the printer.
9. Probe extension module Used for extend ports for connecting probes (optional).
10. Protective handle Used for moving the trolley and protecting the trolley from
crash during moving.
11. Anti-theft lock Used for releasing the main unit from the trolley.

B-4 Operator’s Manual

C Electrical Safety Inspection

The following electrical safety tests are recommended as part of a comprehensive preventive
maintenance program. They are a proven means of detecting abnormalities that, if undetected,
could prove dangerous to either the patient or the operator. Additional tests may be required
according to local regulations.
All tests can be performed using commercially-available safety analyzer test equipment. These
procedures assume the use of a 601PROXL International Safety Analyzer or equivalent safety
analyzer. Other popular testers which comply with IEC 60601-1 and are used in Europe, such as
Fluke, Metron or Gerb, may require modifications to the procedure. Follow the analyzer
manufacturer's instructions.
An electrical safety inspection should be periodically performed every two years. The safety
analyzer is also an excellent troubleshooting tool for detecting abnormalities in line voltage and
grounding, as well as total current loads.

NOTE:
Make sure the safety analyzer is authorized and complies with the requirements of IEC 61010-1.
Follow the analyzer manufacturer's instructions.

C.1 Power Cord Plug

C.1.1 The Power Plug

Test Item Acceptance Criteria

The power plug The power plug pins No broken or bent pins. No discolored pins.
The plug body No physical damage to the plug body.
The strain relief No physical damage to the strain relief. No plug
warmth when device is in use.
The power plug No loose connections.
The power cord No physical damage to the cord. No deterioration to
the cord.
For devices with detachable power cords, inspect the
connection with the device.
For devices with non-detachable power cords, inspect
the strain relief at the device.

Operator’s Manual C-1

C Electrical Safety Inspection

C.2 Device Enclosure and Accessories

C.2.1 Visual Inspection

Test Item Acceptance Criteria

The enclosure and No physical damage to the enclosure and accessories.
accessories
No physical damage to meters, switches, connectors, etc.
No residue of fluid spillage (e.g., water, coffee, chemicals, etc.).
No loose or missing parts (e.g., knobs, dials, terminals, etc.).

C.2.2 Contextual Inspection

Test Item Acceptance Criteria

The enclosure and No unusual noises (e.g., rattles inside the case).
accessories
No unusual smells (e.g., burning or smoky smells, particularly from
ventilation holes).
No taped notes that may suggest device deficiencies or operator
concerns.

C.3 Device Labeling

Check that the labels provided by the manufacturer or the healthcare facility are present and legible.
• Main unit label
• Integrated warning labels

C.4 Protective Earth Resistance

1. Plug the analyzer probes into the device’s protective earth terminal and the protective earth
terminal of the AC power cord.
2. Test the earth resistance with a current of 25 A.
3. Verify the resistance is less than the limits.

LIMITS
ALL COUNTRIES R = 0.2 Ω Maximum

C.5 Earth Leakage Test

Run an Earth Leakage test on the device being tested before performing any other leakage tests.
The following outlet conditions apply when performing the Earth Leakage test.
• normal polarity (Normal Condition);
• reverse polarity (Normal Condition);

C-2 Operator’s Manual

 C Electrical Safety Inspection

• normal polarity with open neutral (Single Fault Condition);

• reverse polarity with open neutral (Single Fault Condition).

LIMITS
• For ES 60601-1:
– 300 μA in Normal Condition.
– 1000 μA in Single Fault Condition.
• For IEC 60601-1:
– 500 μA in Normal Condition.
– 1000 μA in Single Fault Condition.

C.6 Enclosure Leakage Test

The following outlet conditions apply when performing the Enclosure Leakage test.
• normal polarity (Normal Condition);
• reverse polarity (Normal Condition);
• normal polarity with open neutral (Single Fault Condition);
• reverse polarity with open neutral (Single Fault Condition);
• normal polarity with open earth (Single Fault Condition);
• reverse polarity with open earth (Single Fault Condition).

LIMITS
• For ES 60601-1
– 100 μA in Normal Condition.
– 300 μA in Single Fault Condition.
• For IEC 60601-1:
– 100 μA in Normal Condition.
– 500 μA in Single Fault Condition.

C.7 Patient Leakage Current

Patient leakage currents are measured between a selected applied part and mains earth. All
measurements have a true RMS only.
The following outlet conditions apply when performing the Patient Leakage Current test.
• normal polarity (Normal Condition);
• reverse polarity (Normal Condition);
• normal polarity with open neutral (Single Fault Condition);
• reverse polarity with open neutral (Single Fault Condition).
• normal polarity with open earth (Single Fault Condition);
• reverse polarity with open earth (Single Fault Condition).

LIMITS
For BF applied parts:
• 100 μA in Normal Condition.
• 500 μA in Single Fault Condition.

Operator’s Manual C-3

C Electrical Safety Inspection

C.8 Mains on Applied Part Leakage

The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage using a
limiting resistance, to selected applied part terminals. Current measurements are then taken
between the selected applied part and earth. Measurements are taken with the test voltage (110% of
mains) on applied parts in the normal and reverse polarity conditions.
The following outlet conditions apply when performing the Mains on Applied Part test.
• Normal Polarity;
• Reversed Polarity.

LIMITS
For BF applied parts: 5000 μA.

C.9 Patient Auxiliary Current

Patient Auxiliary currents are measured between any selected Applied Part connector and the
remaining Applied Part connectors. All measurements may have a true RMS response.
The following outlet conditions apply when performing the Patient Auxiliary Current test.
• normal polarity (Normal Condition);
• reverse polarity (Normal Condition);
• normal polarity with open neutral (Single Fault Condition);
• reverse polarity with open neutral (Single Fault Condition);
• normal polarity with open earth (Single Fault Condition);
• reverse polarity with open earth (Single Fault Condition).

LIMITS
For BF applied parts,
• 100 μA in Normal Condition.
• 500 μA in Single Fault Condition.

C-4 Operator’s Manual

D Wireless LAN

The system provides wireless net adapter configuration, so as to assist information query and
unlimited network service. The ultrasound system can be connected to router, mobile phone, tablet,
ultrasound workstation, server network device and so on via wireless network

WARNING
• Use the wireless LAN function prudently in OR/ICU/CCU as it may interfere
with other devices.
• When the wireless LAN function is turned on, the ultrasound system may
suffer interference from other equipment, even if that other equipment
complies with CISPR EMISSION requirements.
• Keep at least 20 cm away from the ultrasound system when the wireless
LAN function is in use.

NOTE:
Disconnection may be caused if the devices connected excess the router capacity (please refer to
settings of the router, generally it should be ≤5.)
DO NOT connect devices other than specified into the LAN.
Medical devices within the same LAN may interfere with each other, the operator should be
cautious. (Do not connect devices that may cause strong interference. For example, life-supporting
devices should not be connected in the same LAN.)
Other non-medical devices in the same frequency band may cause interference, please be cautious.
For a better wireless LAN transmission effect, please take the following settings:
• SSID > 80% with stable WLAN network.
• Wireless router and the server are in the same network segment.
• Router setting:
– Wireless standard IEEE 802.11 ac/a/b/g/n.
– Maximum transmission speed 300 Mbps.
– Number of the devices connected to the same router ≤5.
• Target server setting:
– Network is stable and not under overloading state (e.g. high CPU/memory usage, fast
HDD speed, limited HDD space).
– Level other than the highest level of firewall is adopted.
– Operating system is Windows 10 or higher versions and it supports a Gigabit Ethernet.

D.1 Use the Wireless feature

Perform the following procedure:

Operator’s Manual D-1

D Wireless LAN

1. Press <Cursor> to show the cursor, click in the bottom bar to open the wireless network
manager.
2. Move the cursor to the target network and press <Set> to select it, then click [Connect] to
connect to the network.
3. When connecting an encrypted network, enter the password in the box first. You can select to
hide password characters or not.
4. The system tries to connect and the wireless manager icon turns into . The icon turns into
or after successful connection.
5. Click [Refresh] to refresh the “Wireless Network Connection” list.

D.2 IP Configure
NOTE:
• When the system background is processing network task (DICOM sending for example),
please do not enter network setting to change the IP, otherwise the background task may fail.
You can check if there are tasks undergoing in the task manager.
• If the IP address displays as 0.0.0.0, this means that the network is abnormal. The reason for
the failure may be disconnection or the system cannot obtain the IP address.

IP config is used for setting local network parameters, which is also applied to DICOM connection.
Perform the following procedure:
1. In Wireless network manager screen, click [IP Config] to open the configuration page.
– If “DHCP” is selected, the IP address will be automatically obtained from the DNS server.
– If “Static” is selected (using a static IP address), enter the IP address.
IP address of the system should be in the same network segment with the server.
2. Click [OK] to save current setting. Click [Cancel] to exit.

D.3 EAP Network

For setting EAP network, contact Mindray Customer Service Department or the sales
representatives.

D-2 Operator’s Manual

E iScanHelper

By providing the referential information, such as, the ultrasonic image, the anatomic graphic,
scanning pictures/other scanning tips or diagnosis comments, the system helps the doctors to
operate the scanning by iScanHelper. Furthermore, it is a good platform for the self-learning and
training of ultrasound scanning technique for doctors. The system also plays a role in the assistant
software system in fulfilling training and education.

NOTE:
THIS “iScanHelper” IS FOR REFERENCE OR TUTORIAL PURPOSES ONLY, AND THE
MANUFACTURER WILL NOT BE LIABLE FOR DAMAGES AND/OR OTHER
UNDESIRABLE CONSEQUENCE IN ANY KIND THAT MAY OCCUR TO THE PATIENT OR
THE USERS BY USING THE SOFTWARE.

TIP:
iScanHelper feature is available under abdominal, gynecological, urological, obstetrical, small parts
and nerve block area.

E.1 Use iScanHelper for Reference

Perform the following procedure:
1. Perform ordinary scanning procedure.
2. Press the user-defined key for “iScanHelper” to enter iScanHelper status.
3. Use the trackball/trackpad to move the cursor onto the target view name in the view selecting
box and then press <Set>.
4. Perform scanning according to information displayed on the help information area.
5. Press the user-defined key again to exit.

E.2 Use iScanHelper for Learning or Training

Perform the following procedure:
1. Switch to the exam modes that support iScanHelper.
2. Press the user-defined key for “iScanHelper” to enter iScanHelper status.
3. Learn and practice views by system defaulted sequence according to the information displayed
on help information area; or select unfamiliar views to practice.
4. Press the user-defined key again to exit iScanHelper.

Operator’s Manual E-1

E iScanHelper

E.3 Basic Screen and Operation

E.3.1 View Selecting Area

2 5

1 Section selecting box Move the cursor onto the target view and press <Set> to select
a section.
2 Anatomic graphic Related anatomical tissue information are provided here.
3 Scanning picture Ordinary scanning tips can be observed here, including
posture, probe mark, probe swing/sweep techniques.
4 Scanning tips You can read tissue related anatomical information and
adjacent tissue information here.
5 Ultrasonic image It is used to compare with images scanned by the operator.

E.3.2 Single/quad-window Display

You can zoom in the anatomic graphic, ultrasonic image as well as scanning picture to view those
information more conveniently.

Press <Cursor> to obtain the cursor. Move the cursor on the anatomic graphic, the ultrasound image
or scanning tips.
• Double-click Anatomic graphic, Scanning picture or Ultrasonic image to go to the single
window of each of them.
• Double-click single window again to return to quad-window display.

E-2 Operator’s Manual

F iVision

The iVision function is used to demonstrate the stored images. Image files are played one by one
according to file names (including system-relevant and PC-compatible format images).
Perform the following procedure:
1. Press the user-defined key for “iVision” to enter the iVision screen.
2. Add the contents to be played and select demo mode.
3. Select an item in the list and click [Start] to begin the demonstration.
4. Click [Exit] to exit iVision status.

F.1 Demonstration item

Demonstration items are image files in formats supported by the system. You can add exam data
from the patient database or system-supported image files and folders to the demonstration list. For
files and folders in the demonstration list, the images in the directory and subdirectory are played
one by one, and the system will automatically skip files that cannot be opened.

F.2 Demonstration catalog

There are two kinds of catalog: Demo Catalog and Customize Catalog.

F.2.1 Demo Catalog

The demo catalog is a folder on the hard disk where the factory DEMO is stored. The system plays
the images in this folder when performing demonstrations.
The system supports importing, deleting or clearing the data in the demo catalog.
Click [Demo Manager] to operate:
• [>]: to import data into the demo catalog.
• [<]: to delete selected data.
• [<<]: to delete all data.

F.2.2 Customize Catalog

The catalog of the displayed images is saved here. The system plays the images in the catalog when
performing demonstrations.
Operate the catalog or the files using the buttons on the right:
• [Add File]: to add files to the file list.
• [Add Catalog]: to add a catalog of files to the list.
• [Delete]: to delete selected files or catalogs from the file list.
• [Clear]: to clear all the files or catalogs in the file list.
• [Export]: to export selected directories/files to external storage devices. Click [Export] to bring
up the Browse dialog box, select the path and click [OK].

Operator’s Manual F-1

F iVision

F.3 Copy the file

Transfer files between the mobile hard disk and the ultrasound system
Perform the following procedure:
1. Plug the USB disk, and click [Copy File].
2. Select the path of the source file from the “Drive” and “File Name”.
3. Click [Choose Catalog]. Select the path of the source file from the “Drive” and “File Name”,
and then click [OK].
4. Click [OK] again to complete the task.

F.4 Demonstration mode

The system automatically plays all the image files in the list one by one.
The time interval between images played is same and can be changed.

F.5 Option of Demo

You can choose whether to repeat the demonstration or exit after a demonstration is completed.

F-2 Operator’s Manual

G List of Vocal Commands

The ultrasound system can automatically recognize some vocal commands. You can use a
microphone device to input the vocal commands as shown in the following table. After the input
command is recognized, the system automatically performs the corresponding operations.

Vocal command Operation

Hello Mindray Turn On Audio Control
Turn Off Turn Off Audio Control
B Mode Back to B Mode
CDI Mode Turn on/off CDI Mode
Power Mode Turn on/off Power Mode
M Mode Turn on/off M Mode
PW Mode Turn on/off PW Mode
3D Turn on/off 3D Mode
Freeze Freeze Image
UnFreeze UnFreeze Image
Clear Clear
Dual Enter Dual Windows Format
Quad Enter Quad Windows Format
QSave QSave
Update Update
Full Image Turn on/off Full Image Mode
Middle Line Display/Hide Middle Line
iNeedle Turn on/off iNeedle Mode
iTouch Turn on iTouch Mode
Depth Increase Depth Increase One
Depth Decrease Depth Decrease One
Gain Increase Gain Increase One
Gain Decrease Gain Decrease One
Gain Auto Increase Gain Auto Increase
Gain Auto Decrease Gain Auto Decrease
Gain Stop Gain Stop Auto Increase/Decrease
Zoom In Zoom In Image
Zoom Out Zoom Out Image

Operator’s Manual G-1

G List of Vocal Commands

Vocal command Operation

Open Smart Track Turn on Smart Track Mode
Close Smart Track Turn off Smart Track Mode
Sound Volume Up Turn Sound Volume Up
Sound Volume Down Turn Sound Volume Down
Angle More Angle More One
Angle Less Angle Less One
Left Steer Left Steer the Color ROI or Linear Image
Right Steer Right Steer the Color ROI or Linear Image
BaseLine Down Decrease the Baseline Position
BaseLine Up Increase the Baseline Position
Save Image Save Image
Save Clip Save Clip
Save Screen Save Screen
Adult Abdomen Switch Exam Mode to Adult Abdomen
Abdomen Difficult Switch Exam Mode to Adult Abdomen Difficult
Pediatric Abdomen Switch Exam Mode to Pediatric Abdomen
Bowel Switch Exam Mode to Bowel
Abdomen Vascular Switch Exam Mode to Abdomen Vascular
Neonatal Abdomen Switch Exam Mode to Neonatal Abdomen
Adult Cardiac Switch Exam Mode to Adult Cardiac
Cardiac Difficult Switch Exam Mode to Adult Cardiac Difficult
Pediatric Cardiac Switch Exam Mode to Pediatric Cardiac
Left ventricular Switch Exam Mode to LVO
opacification
Neonatal Cardiac Switch Exam Mode to Neonatal Cardiac
TEE Cardiac Switch Exam Mode to TEE Cardiac
Coronary Artery Switch Exam Mode to Coronary Artery
Gynecology Switch Exam Mode to Gynecology
1st Trimester Switch Exam Mode to 1st Trimester
2nd & 3rd Trimester Switch Exam Mode to 2nd & 3rd Trimester
Fetal Echo Switch Exam Mode to Fetal Echo
Kidney Switch Exam Mode to Kidney
Urology Switch Exam Mode to Urology
Prostate Switch Exam Mode to Prostate
Transcranial Imaging Switch Exam Mode to Transcranial Imaging
Carotid Switch Exam Mode to Carotid
Upper External Artery Switch Exam Mode to Upper Ext Artery

G-2 Operator’s Manual

 G List of Vocal Commands

Vocal command Operation

Lower External Artery Switch Exam Mode to Lower Ext Artery
Upper External Vein Switch Exam Mode to Upper Ext Vein
Lower External Vein Switch Exam Mode to Lower Ext Vein
Thyroid Switch Exam Mode to Thyroid
Breast Switch Exam Mode to Breast
Testicle Switch Exam Mode to Testicle
Musculoskeletal Switch Exam Mode to Musculoskeletal
Superficial Switch Exam Mode to Superficial
Shoulder Switch Exam Mode to Shoulder
Intraoperative Switch Exam Mode to Intraoperative
Nerve Block Switch Exam Mode to Nerve Block
Emergency Abdomen Switch Exam Mode to Emergency Abdomen
Emergency FAST Switch Exam Mode to Emergency Focused Assessment with
Sonography for Trauma
Emergency Obstetrics Switch Exam Mode to Emergency Obstetrics
Emergency Vascular Switch Exam Mode to Emergency Vascular
Emergency Superficial Switch Exam Mode to Emergency Superficial
Lung Switch Exam Mode to Lung
Neonatal Head Switch Exam Mode to Neonatal Head
Orthopedic Switch Exam Mode to Orthopedic
Deep Nerve Switch Exam Mode to Deep Nerve
Superficial N Switch Exam Mode to Superfical Nerve
Renal Artery Switch Exam Mode to Renal Artery
Ocular Switch Exam Mode to Ocular
Wrist Switch Exam Mode to Wrist
Emergency AAA Switch Exam Mode to Emergency Abdomen Aorta An-eurysm
Emergency Cardiac Switch Exam Mode to Emergency Cardiac
IMT Switch Exam Mode to IMT
Open Patient Info Open Patient Info Dialog
Dialog
Close Patient Info Close Patient Info Dialog
Dialog
Open Probe Dialog Open Probe Dialog
Close Probe Dialog Close Probe Dialog
Open Review Dialog Open Review Dialog
Close Review Dialog Close Review Dialog
Open Report Dialog Open Report Dialog

Operator’s Manual G-3

G List of Vocal Commands

Vocal command Operation

Close Report Dialog Close Report Dialog
Open Preset Dialog Open Preset Dialog
Close Preset Dialog Close Preset Dialog
Smart IVC Smart IVC
Smart VTI Smart VTI
Smart B-lines Smart B-lines

G-4 Operator’s Manual

H Acoustic Output

This section of the operator’s manual applies to the overall system including the main unit, probes,
accessories and peripherals. This section contains important safety information for operators of the
device, pertaining to acoustic output and how to control patient exposure through use of the
ALARA (as low as reasonably achievable) principle. Also this section contains information
regarding the acoustic output testing and the real-time output display.
Read this information carefully before using the system.

H.1 Concerns with Bioeffects

Diagnostic ultrasound is recognized as being safe. In fact, there have been no reports of injuries to
patients caused by diagnostic ultrasound.
It cannot be stated categorically that ultrasound is 100% safe. Studies have revealed that ultrasound
with extremely high intensity is harmful to body tissues.
Diagnostic ultrasound technology has made a great leap forward during the last several years. This
rapid advance has generated concerns about the potential risk of bioeffects when new applications
or diagnostic technologies become available.

H.2 Prudent Use Statement

Although there are no confirmed biological effects on patients caused by exposures from present
diagnostic ultrasound instruments, the possibility exists that such biological effects may be
identified in the future. Thus ultrasound should be used in a prudent manner to provide medical
benefit to the patient. High exposure levels and long exposure times should be avoided while
acquiring necessary clinical information.

H.3 ALARA Principle (As Low As Reasonably

Achievable)
It is required to practice ALARA when using ultrasound energy. Practicing ALARA ensures that
the total energy level is controlled below a low enough level at which bioeffects are not generated
while diagnostic information is being accumulated. The total energy is controlled by output
intensity and total radiation time. The output intensity necessary for examinations differs depending
on the patient and the clinical case.
Not all examinations can be performed with an extremely low level of acoustic energy. Controlling
the acoustic level at an extremely low level leads to low-quality images or insufficient Doppler
signals, adversely affecting the reliability of the diagnosis. However, increasing the acoustic power
more than necessary does not always contribute to an increase in quality of information required for
diagnosis, rather increasing the risk of generating bioeffects.
Users must take responsibility for the safety of patients and utilize ultrasound deliberately.
Deliberate use of ultrasound means that output power of ultrasound must be selected based on
ALARA.

Operator’s Manual H-1

H Acoustic Output

Additional information regarding the concept of ALARA and the possible bioeffects of Ultrasound is
available in a document from the AIUM (American Institute of Ultrasound Medicine) title “Medical
Ultrasound Safety”.

H.4 MI/TI Explanation

H.4.1 Basic Knowledge of MI and TI
Mechanical Bioeffect and Thermal Bioeffect
The relationship of various ultrasound output parameters (frequency, acoustic pressure and
intensity, etc.) to bioeffects is not fully understood presently. It is recognized that two fundamental
mechanisms may induce bioeffects. One is a thermal bioeffect with tissue absorption of ultrasound,
and another one is a mechanical bioeffect based on cavitations. Thermal Index (TI) gives the
relative index of temperature increase by thermal bioeffect, and Mechanical Index (MI) gives the
relative index of mechanical bioeffect. TI and MI indices reflect instantaneous output conditions, so
they DO NOT consider the cumulative effects of the total examination time. TI and MI models
contain practical simplifications to complex bioeffects interaction. Then the operator should be
aware that the actual worst case temperature rise may be up to several times higher than the
displayed TI value.

MI (Mechanical Index)
The mechanical bioeffects are the result of compression and decompression of insonated tissues
with the formation of micro bubbles that may be referred to as cavitations.
MI is an index that shows the possibility of the cavitations generation based on acoustic pressure,
and the value in which the peak-rarefactional acoustic pressure is divided by the square root of the
frequency. Therefore MI value becomes smaller when the frequency is higher or the peak-
rarefactional acoustic pressure is lower, it becomes difficult to generate the cavitations.

P r, 
MI = -------------------------------------
-
f awf  C MI

CMI = 1 (MPa / MHz )

For the frequency 1 MHz and the peak rarefactional acoustic pressure 1 MPa, MI becomes 1. It is
possible to think MI to be one threshold of the cavitations generation. Especially, it is important to
keep MI value to be low when both gases and the soft tissues exist together, for such as lung
exposure in cardiac scanning and bowel gas in abdominal scanning.

TI (Thermal Index)
TI is determined by the ratio of the total acoustic power to the acoustic power required to raise the
tissue temperature by 1 degree C. In addition, because the temperature rises is greatly different
according to tissue structures, TI is divided three kinds: TIS (Soft-tissue Thermal Index), TIB
(Bone Thermal Index) and TIC (Cranial-bone Thermal Index).

• TIS: Thermal index related to soft tissues, such as abdominal and cardiac applications.
• TIB: Thermal index for applications, such as fetal (second and third trimester) or neonatal
cephalic (through the fontanel), in which the ultrasound beam passes through soft tissue and a
focal region is in the immediate vicinity of bone.
• TIC: Thermal index for applications, such as pediatric and adult cranial applications, in which
the ultrasound beam passes through bone near the beam entrance into the body.

H-2 Operator’s Manual

 H Acoustic Output

Although the output power is automatically controlled for the selected applications, high TI values
should be kept to a minimum or avoided in obstetric applications. WFUMB (World Federation for
Ultrasound in Medicine and Biology) guidelines: state that temperature increase of 4 degree C for 5
min or more should be considered as potentially hazardous to embryonic and fetal tissue.
The smaller the MI/TI values, the lower the bioeffects.

H.4.2 MI/TI Display

TI and MI values are displayed in the upper part of the screen in real-time. The operator should
monitor these index values during examinations and ensure that exposure time and output values
are maintained at the minimum amounts needed for effective diagnosis.

NOTE:
If there is a value of MI or TI exceeds 1.0, you must be careful to practice the ALARA
principle.

The display precision is 0.1.

Real-time Display accuracy: MI ≤ 28.5%, TI ≤ 38.7%

H.5 Acoustic Power Setting

Acoustic power adjustment
Use the [A.power] to adjust the acoustic power percentage, and its value is displayed on the
corresponding item, as well as at the top of the screen. The greater the acoustic power percentage,
the greater the current acoustic output. When the image is frozen, the system stops transmitting
acoustic power.

Default setting of acoustic power

Selection of diagnostic applications is the most important factor for controlling ultrasound output.
The permissible level of intensity of ultrasound differs depending on the region of interest. For fetal
examinations, in particular, much care must be exercised.
In this system, imaging setups can be created using the ultrasound output set by you.
Once you perform preset settings, default setting values of the system may be changed and invalid.
It is the user’s responsibility for any change to the default settings.

Adjusting range
Initial power: 0.13% to 100%*

Definition of 100%: The maximum acoustic power of a probe determined by the increase in probe
surface temperature in the selected mode and the acoustic power restrictions specified by the FDA.
Default settings of acoustic power value refer to the best image quality of the probe. The larger the
acoustic power value, the better the image quality.
In this product, to obtain optimum images for applications under the requirements of safety and
ALARA principle, we set acoustic power default values in factory to be maximum 93.33% in all
exam modes for a better image quality. The user can make adjustments according to the imaging
effect in practical use.

Operator’s Manual H-3

H Acoustic Output

NOTE:
This system automatically returns to the settings whenever changes are made to the values
(when you turn on the power, switch between probes, end the exam, or select OK or Cancel in
the Setup menu). In the factory default settings, the Acoustic Output is limited below 100%.
Following the ALARA restriction, you are allowed to increase the acoustic power under FDA
510 (k) Guidance-Track 3 limits and to set it in the image preset screen.

The acoustic output of the system has been measured and calculated in accordance with IEC60601-
2-37: 2015, FDA 510(K) GUIDANCE, IEC 62359: 2017, Ultrasonics-Field characterization-Test
methods for the deter mination of thermal and mechanical indices related to medical diagnostic
ultrasonic fields.

H.6 Acoustic Power Control

The qualified operator may use the system controls to limit the ultrasound output and to adjust the
quality of the images. There are three categories of system controls relative to output. They are,
• Controls that have direct effect on the output
• Controls that indirectly control output
• Controls that are receiver controls

Direct controls
It is possible to control, if necessary, the acoustic output with the “A.power” item. In this case, the
maximum value of the acoustic output never exceeds an MI of 1.9 and an ISPTA.3 of 720 mW/cm2
in any mode of operation.

Indirect controls
The controls that indirectly affect output are the many imaging parameters. These are operating
modes, frequency, focal point positions, overall depth, and PRF.
The operating mode determines whether the ultrasound beam is scanning or non-scanning. Thermal
bioeffect is closely connected to M mode, Doppler and Color mode. Acoustic attenuation of tissue
is directly related to probe frequency. The focal point is related to active aperture of probe and beam
width. For the higher PRF (pulse repetition frequency), the more output pulses occur over a period
of time.

Receiver controls
The receiver controls (for example, gain, dynamic range, and image post-processing, etc.) won’t
affect output. These controls should be used, when possible, to improve the image quality before
using controls that directly or indirectly affect output.

H.7 Acoustic Output

H.7.1 Derated Ultrasonic Output Parameters
In order to determine the relevant Ultrasonic Output Parameters, a method is used which allows for
the comparison of ultrasound systems which operate at different frequencies and are focused at
different depths. This approach, called “derating” or “attenuating”, adjusts the acoustic output as
measured in a water tank to account for the effect of ultrasound propagation through tissue. By
convention, a specific average intensity attenuation value is used, which corresponds to a loss of 0.3
dB/cm/MHz. That is, the intensity of ultrasound will be reduced by 0.3 dB/MHz for every
centimeter of travel from the probe. This can be expressed by the following equation:

H-4 Operator’s Manual

 H Acoustic Output

  – 0.3   10  f c  z 
I atten = I water  10

Where Iatten is the attenuated intensity, Iwater is the intensity measured in a water tank (at distance
z), fc is the center frequency of the ultrasound wave (as measured in water), and z is the distance
from the probe. The equation for attenuating pressure values is similar except that the attenuation
coefficient is 0.15 dB/cm/MHz, or one-half the intensity coefficient. The intensity coefficient is
double the pressure coefficient because intensity is proportional to the square of pressure.
Although the attenuation coefficient chosen, 0.3 dB/cm/MHz, is significantly lower than any
specific solid tissue in the body, this value was chosen to account for fetal examinations. In early
trimester ultrasound fetal examinations, there may be a significant fluid path between the probe and
the fetus, and the attenuation of fluid is very small. Therefore the attenuation coefficient was
lowered to account for this case.

H.7.2 Limits of Acoustic Output

In accordance with the FDA Track 3 requirements, the derating (or attenuated) approach was
incorporated into the FDA Acoustic Output Limits, as listed below. The maximum acoustic output
level from any probe in any operating mode is expected to fall below these limits.
FDA Maximum Acoustic Output Limits for Track 3 (Attenuated Values)

Application: Ispta.3 (mW/cm2) ≤ 720 Isppa.3 (W/cm2) ≤ 190 or MI ≤ 1.9

Regions (except eyes)
Application: Ophthalmic Ispta.3 (mW/cm2) ≤ 50 MI≤ 0.23

H.7.3 Differences between Actual and Displayed MI and TI

In operation, the system will display to the operator the Acoustic Output Parameters Thermal
Index, TI, or Mechanical Index, MI (or sometimes both parameters simultaneously). These
parameters were developed as general indicators of risk from either thermal or mechanical action of
the ultrasound wave. They serve to indicate to the operator whether a particular setting of the
system increases or decreases the possibility of Thermal or Mechanical effect. More specifically,
they were designed to assist in the implementation of the ALARA principle. As an operator
changes a given system control, the potential effect of the change in output will be indicated.
However, the Thermal Index is not the same as temperature rise in the body, for several reasons.
First of all, in order to provide a single display index to you, a number of simplifying assumptions
had to be made. The biggest assumption was the use of the attenuating formula described above,
which is much lower than the actual value for most tissues within the body. Scanning through
muscle or organ tissue, for example, will produce much higher attenuation than 0.3 dB/cm/MHz.
There were also significant simplifications made for the thermal properties of tissue. Therefore,
scanning through highly perfused tissue, such as the heart or vasculature, will produce significantly
less thermal effect than that suggested by the Thermal Index.
Similarly, the Mechanical Index was derived to indicate the relative possibility of mechanical
(cavitation) effects. The MI is based on the derated peak-rarefactional pressure and the center
frequency of the ultrasound wave. The actual peak-rarefactional pressure is affected by the actual
attenuation caused by tissue in the path between the probe and the focal point. Again, all solid
tissues within the body have higher attenuation than the prescribed 0.3 dB/cm/MHz value, and
therefore, the actual peak-rarefactional pressure will be lower. Further, the actual peak-rarefactional
pressure will change depending upon the region of the body being scanned.
For these reasons, the TI and MI displays should only be used to assist the operator in implementing
ALARA at the time of the patient examination.

Operator’s Manual H-5

H Acoustic Output

H.8 Measurement Uncertainty

The total estimated measurement uncertainty (where the total uncertainty includes the uncertainties
in hydrophone response, measurement, calculation, and positioning) are:

Acoustic Quantities Total Uncertainties (Standard)

Power 26.48% for non-scan modes; 6.03% for scan modes.
Frequency 0.22%
Pressure 13.01%
Ita 26.48% for non-scan modes; 26.95% for scan modes.
Ipa 26.5%
Mechanical Index 13.01%
Total Uncertainty for TIS Non-scan Modes: 26.48%; Scan-Modes: 6.03%
Total Uncertainty for TIB Non-scan Modes: 26.48% or 18.72%; Scan-Modes: 6.03%
Total Uncertainty for TIC Non-scan Modes: 26.48%; Scan-Modes: 6.03%

H.9 References for Acoustic Power and Safety

• “Bioeffects and Safety of Diagnostic Ultrasound” issued by AIUM in 1993
• “Medical Ultrasound Safety” issued by AIUM in 1994
• Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, June 27, 2019.
Center for Devices and Radiological Health.
• Medical electrical equipment-Part 2-37: Particular requirements for the basic safety and
essential performance of ultrasonic medical diagnostic and monitoring equipment issued by
IEC in 2015
• IEC 62359, Ultrasonics-Field characterization-Test methods for the determination of thermal
and mechanical indices related to medical diagnostic ultrasonic fields, 2017.

H-6 Operator’s Manual

I EMC Guidance and
Manufacturer’s Declaration

The system complies with the EMC standard IEC 60601-1-2: 2014+A1:2020.
Intended Environments: HOME HEALTHCARE ENVIRONMENT (except for the probe P7-3Ts/
P8-3Ts/CW2s.
Intended Environments: Professional healthcare facility environment (including the probe P7-3Ts/
P8-3Ts/CW2s)

WARNING
• The use of unapproved accessories may diminish system performance.
• Use of components, accessories, probes, and cables other than those
specified may result in increased emission or decreased immunity of
system.
• Operation of system, in the case that the patient physiological signal is
lower than the minimum amplitude or value specified in the product
specifications, results may not be obtained (results can be obtained when
the HR is in the range of 30-250 bmp or when the QRS wave amplitude is
between 0.5-5 mV.)
• Use of this equipment adjacent to or stacked with other equipment should
be avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to
verify that they are operating normally.
• Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
• Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30
cm (12 inches) to any part of the system, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment
could result.
• Keep a distance of at least 20 cm away from the monitor when WiFi
function is in use.
• The system should be away from RFID, MRI, diathermy, and electrocautery
testing, wireless power transfer, 5G cellular and security equipment (such
as electromagnetic anti-theft system and metal detector). If the devices are
near and are interfered by the concealed and undiscovered RF transmitter
(for example, scanning mode changes or image disturbances affecting

Operator’s Manual I-1

I EMC Guidance and Manufacturer’s Declaration

diagnosis), the user should immediately take mitigation measures, such as

redirecting, repositioning or shielding the RF transmitter.
• This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against harmful interference
in a residential installation. This equipment generates, uses and can
radiate radio frequency energy and, if not installed and used in accordance
with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct
the interference by one or more of the following measures:
– Reorient or relocate the receiving antenna.
– Increase the separation between the equipment and receiver.
– Connect the equipment into an outlet on a circuit different from that to
which the receiver is connected.
– Consult the dealer or an experienced radio/TV technician for help.
Any Changes or modifications not expressly approved by the party
responsible for compliance could void the user's authority to operate the
equipment.
• The device has been evaluated to meet general RF exposure requirement.
The device can be used in portable exposure condition without restriction.
This device complies with part 15 of the FCC Rules. Operation is subject to
the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.

NOTE:
If the system is operated within the electromagnetic environment listed in Table I-1, Table I-2,
Table I-3, Table I-4, Table I-5 and Table I-6, the system will remain safe and will provide the
following basic performances:
• Imaging;
• Doppler acoustic spectral displaying;
• Taking measurements;
• Patient information;

I-2 Operator’s Manual

 I EMC Guidance and Manufacturer’s Declaration

• Date/time information.

Table I-1
GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC EMISSIONS
The system is intended for use in the electromagnetic environment specified below. The
customer or the user of system should assure that it is used in such an environment.
EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIROMENT - GUIDANCE
RF emissions Group 1 The system uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF emissions Class B The system is suitable for use in all establishments
CISPR 11 including domestic establishments and those directly
connected to the public low-voltage power supply network
Harmonic Emissions Class A that supplies buildings used for domestic purposes
IEC 61000-3-2
Voltage Fluctuations/ Compliance
Flicker Emissions
IEC 61000-3-3

Table I-2
GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC EMISSIONS
The Probe which integrated in the system is intended for use in the electromagnetic
environment specified below. The customer or the user of system should assure that it is
used in such an environment.
EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIROMENT - GUIDANCE
RF emissions Group 1 The Probes uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF emissions Class A The Probe is suitable for use in all establishments other
CISPR 11 than domestic and those directly connected to the public
low-voltage power supply network that supplies buildings
Harmonic Emissions Class A used for domestic purposes
IEC 61000-3-2
Voltage Fluctuations/ Compliance
Flicker Emissions
IEC 61000-3-3

Operator’s Manual I-3

I EMC Guidance and Manufacturer’s Declaration

Table I-3
GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC IMMUNITY
The system is intended for use in the electromagnetic environment specified below. The
customer or the user of system should assure that it is used in such an environment.
IMMUNITY TEST IEC 60601 COMPLIANCE LEVEL ELECTROMAGNETIC
TEST LEVEL ENVIRONMENT-
GUIDANCE

Electrostatic ±8 kV contact; ±8 kV contact; Floors should be wood,

Discharge(ESD) ±2 kV, ±4 kV, ±8 kV, ±15 ±2 kV, ±4 kV, ±8 kV, ±15 concrete or ceramic tile. If
IEC 61000-4-2 kV air kV air floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast Transient / ±2 kV for power supply ±2 kV for power supply Mains power quality
burst lines; lines; should be that of a typical
IEC 61000-4-4 ±1 kV for input/output ±1 kV for input/output commercial or hospital
lines lines environment.
Surge ±0,5 kV, ±1 kV line(s) to ±0,5 kV, ±1 kV line(s) to Mains power quality
IEC 61000-4-5 line(s); line(s); should be that of a typical
±0,5 kV, ±1 kV, ±2 kV ±0,5 kV, ±1 kV, ±2 kV commercial or hospital
line(s) to earth line(s) to earth environment.
Voltage dips, Short 0 % UT; 0,5 cycle 0 % UT; 0,5 cycle Mains power quality
interruptions and voltage At 0°, 45°, 90°, 135°, At 0°, 45°, 90°, 135°, should be that of a typical
variation on power supply 180°, 225°, 270° and 315° 180°, 225°, 270° and 315° commercial or hospital
input voltage environment. If you
IEC 61000-4-11 require continued
0 % UT; 1 cycle 0 % UT; 1 cycle
operation during power
70% UT for 25/30 cycle 70% UT for 25/30 cycle mains interruptions, it is
at 0° at 0° recommended that our
product be powered from
0 % UT; 250/300 cycle 0 % UT; 250/300 cycle an uninterruptible power
supply or a battery.
Power frequency (50/60 30 A/m 30 A/m Power frequency
HZ) magnetic field magnetic fields should be
IEC 61000-4-8 at levels characteristic of a
typical location in a
typical commercial or
hospital environment.
NOTE:
UT is the A.C. mains voltage prior to application of the test level.

I-4 Operator’s Manual

 I EMC Guidance and Manufacturer’s Declaration

Table I-4
GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC IMMUNITY
The system is intended for use in the electromagnetic environment specified below. The
customer or the user of system should assure that it is used in such an environment.
IMMUNITY IEC 60601 TEST COMPLIANCE ELECTROMAGNETIC
TEST LEVEL LEVEL ENVIRONMENT-GUIDANCE
Portable and mobile RF
3 Vrms communications equipment should be
3 Vrms used no closer to any part of system,
0,15 MHz – 80 MHz
0,15 MHz – 80 MHz including cables, than the recommended
Conduced RF IEC 6 Vrms in ISMa and 6 Vrms in ISM and separation distance calculated from the
61000-4-6 amateur radio bands equation applicable to the frequency of
amateur radio bands
between 0,15 MHz and the transmitter. Recommended
between 0,15 MHz
80 MHz separation distance
and 80 MHz
d = 1.2 × P
d=2× P
d = 1.2 × P 80 MHz to 800 MHz
d = 2.3 × P 800 MHz to 2.7GHz
Where, P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
Radiated RF IEC 10 V/m 10 V/m electromagnetic site surveyb, should be
61000-4-3 80MHz - 2.7GHz 80MHz - 2.7GHz less than the compliance level in each
frequency rangec.
Interference may occur in the vicinity of
equipment marked with the following
symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

Operator’s Manual I-5

I EMC Guidance and Manufacturer’s Declaration

Table I-4
GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC IMMUNITY
The system is intended for use in the electromagnetic environment specified below. The
customer or the user of system should assure that it is used in such an environment.
IMMUNITY IEC 60601 TEST COMPLIANCE ELECTROMAGNETIC
TEST LEVEL LEVEL ENVIRONMENT-GUIDANCE
a: The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795
MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur
radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4
MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0
MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
b: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
device is used exceeds the applicable RF compliance level above, the device should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the device.
c: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Table I-5

GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC IMMUNITY

The system is intended for use in the electromagnetic environment specified below. The customer
or the user of system should assure that it is used in such an environment.
IMMUNITY TEST IEC 60601 COMPLIANCE ELECTROMAGNET
TEST LEVEL LEVEL IC ENVIROMENT –
GUIDANCE
Proximity magnetic 8 A/m 8 A/m /
fields 30 kHz 30 kHz
IEC 61000-4-39 CW CW
65 A/m 65 A/m
134,2 kHz 134,2 kHz
Pulse modulation Pulse modulation
2,1 kHz 2,1 kHz
7,5 A/m 7,5 A/m
13,56 MHz 13,56 MHz
Pulse modulation Pulse modulation
50 kHz 50 kHz

I-6 Operator’s Manual

 I EMC Guidance and Manufacturer’s Declaration

Table I-6 Test specifications and minimum distances

Recommended separation distances between portable and mobile RF communications

equipment and system
The system is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of system can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and The system
as recommended below, according to the maximum output power of the communications equipment. Portable
and mobile radio communications equipment (e.g. two-way radio, cellular/ cordless telephones and similar
equipment) should be used no closer to any part of this system, including cables, than determined according to
the following method:
Test Band(MHz) Service Modulation Maximum Distance Immunity
frequency power (W) (m) test level
(MHz) (V/m)
385 380 - 390 TETRA 400 Pulse 1.8 0.3 27
modulation
18Hz
450 430 -470 GMRS 460 FM ±5 kHz 2 0.3 28
FRS 460 deviation 1
kHz sine
710 704 - 787 LTE Band 13,17 Pulse 0.2 0.3 9
modulation
745
217 Hz
780
810 800 - 960 GSM 800/900, Pulse 2 0.3 28
tetra 800, modulation
870
iDEN 820, 18 Hz
930
CDMA 850,
LTE Band 5
1720 1700 -1990 GSM 1800, Pulse 2 0.3 28
CDMA 1900, modulation
1845
GSM 1900, 217 Hz
1970
DECT,
LTE Band 1, 3, 4,
25, UMTS
2450 2400 -2570 Bluetooth, Pulse 2 0.3 28
WLAN, modulation
802.11 b/g/n, 217 Hz
RFID 2450, LTE
Band 7
5240 5100 -5800 WLAN, Pulse 0.2 0.3 9
802.11 a/n modulation
5500
217 Hz
5785

Operator’s Manual I-7

I EMC Guidance and Manufacturer’s Declaration

Table I-7

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE

RF COMMUNICATION DEVICE AND THE SYSTEM
The system is intended for use in an electromagnetic environment in which radiated RF
disturbance are controlled. The customer or the user of system can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communication
equipment (transmitters) and system as recommended below, according to the maximum output
power of the communication equipment.
Rated Separation Distance According to Frequency of Transmitter
Maximum
150kHz -80MHz 150kHz -80MHz 80MHz-800MHz 800MHz-2.7GHz
Output
power of Out ISM and in ISM and
Transmitter amateur radio amateur radio
bands bands
(W)
d=1.2 P d=2 P d=1.2 P d=2.3 P
0.01 0.12 0.2 0.12 0.23
0.1 0.38 0.64 0.38 0.73
1 1.2 2 1.2 2.3
10 3.8 6.4 3.8 7.3
100 12 20 12 23
For transmitters at a maximum output power not listed above, the recommended separation
distanced in meters (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
If system image distortion occurs, it may be necessary to position system further from sources of
conducted RF noise or to install external power source filter to minimize RF noise to an acceptable
level.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.

Table I-8 Cable sample

No. Name Cable length (m) Shield or not Remarks
1 Power input 2.5m Not shielded /
2 SIP/SOP < 3.0m Shielding /
3 ECG cable 4.0m Shielding /
4 Probe Cable < 3.0m Shielding /
5 Footswitch Cable 2.9m Shielding /

I-8 Operator’s Manual

 I EMC Guidance and Manufacturer’s Declaration

Radio Regulatory Compliance

RF parameter

Features 2.4GHz 5GHz

Frequency Rage 2412MHz - 2483.5MHz 5.15 - 5.25GHz
5.25 - 5.35GHz
5.47 - 5.725GHz
5.725 - 5.850GHz
Modulation DSSS and OFDM OFDM
Output Power ≤20dBm

NOTE:
Keep a distance of at least 20cm away from the monitor when Wi-Fi function is in use.

Operator’s Manual I-9

This page intentionally left blank.
J Indications for Use

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track 1 Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
Only) Doppler Doppler (specify)
Ophthalmic Ophthalmic P P P P
Fetal Imaging & Fetal P P P P P P Note 1,2,4,5
Other Abdominal P P P P P P P Note 1,2,4,5,8

Intra-operative (Specify*) P P P P P P P Note 1,2,5

Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P P Note 1,2,4,5

Small Organ (Specify**) P P P P P P Note 1,2,4,5,6

Neonatal Cephalic P P P P P P P Note 1,2,4,5

Adult Cephalic P P P P P P P Note 1,2,4,5

Trans-rectal P P P P P P Note 1,2,4,5,6

Trans-vaginal P P P P P P Note 1,2,4,5,6

Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal P P P P P P Note 1,2,4,5,6
(Conventional)
Musculo-skeletal P P P P P P Note 1,2,4,5,6
(Superficial)
Intravascular
Thoracic/Pleural P P P P P Note 1,2,4,5
(Specify****)
Cardiac Cardiac Adult P P P P P P P Note 1,2,3,4,5,7
Cardiac Pediatric P P P P P P P Note 1,2,3,4,5
Intravascular (Cardiac)
Trans-esoph. (Cardiac) P P P P P P P Note1,3,4
Intra-cardiac
Peripheral vessel Peripheral vessel P P P P P P Note 1,2,4,5
Other (Specify***) P P P P P P Note 1,2,4,5,6
N=new indication Ϲ P=previously cleared by FDA Ϲ E=added under Appendix E
Additional commentsϸCombined modes--B+MѲ PW+BѲ Color + BѲ Power + BѲ PW +Color+ BѲ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

Operator’s Manual J-1

J Indications for Use

Transducer: C5-1s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
1 Only) Doppler Doppler (specify)
Ophthalmic Ophthalmic
Fetal Imaging& Fetal P P P P P P Note 1,2,4,5
Other Abdominal P P P P P P Note 1,2,4,5,8
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P Note 1,2,4,5
Small Organ (Specify**)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal P P P P P P Note 1,2,4,5
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Thoracic/Pleural P P P P P Note 1,2,4,5
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel P P P P P P Note 1,2,4,5
vessel Other (Specify***) P P P P P P Note 1,2,4,5
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

J-2 Operator’s Manual

 J Indications for Use

Transducer: C11-3s
Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Use:
Clinical Application Mode of Operation
General Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
(Track Doppler Doppler (specify)
1 Only)
Ophthalmic Ophthalmic
Fetal Fetal
Imaging& Abdominal P P P P P P Note 1,2,4
Other Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P Note 1,2,4
Small Organ (Specify**)
Neonatal Cephalic P P P P P P Note 1,2,4
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Thoracic/Pleural P P P P P P Note 1,2,4
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric P P P P P P Note 1,2,4
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel P P P P P P Note 1,2,4
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

Operator’s Manual J-3

J Indications for Use

Transducer: SC5-1Ns
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
Doppler Doppler (specify)
Ophthalmic Ophthalmic
Fetal Imaging& Fetal P P P P P P Note 1,2,4,5
Other Abdominal P P P P P P Note 1,2,4,5,8
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P Note 1,2,4,5
Small Organ (Specify**)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal P P P P P P Note 1,2,4,5
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Thoracic/Pleural P P P P P Note 1,2,4,5
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel P P P P P P Note 1,2,4,5
vessel Other (Specify***) P P P P P P Note 1,2,4,5
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

J-4 Operator’s Manual

 J Indications for Use

Transducer: V11-3s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
1 Only) Doppler Doppler (specify)
Ophthalmic Ophthalmic
Fetal Imaging& Fetal P P P P P P Note 1,2,4,5
Other Abdominal
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify**)
Neonatal Cephalic
Adult Cephalic
Trans-rectal P P P P P P Note 1,2,4,5,6
Trans-vaginal P P P P P P Note 1,2,4,5,6
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Thoracic/Pleural
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel
vessel Other (Specify***) P P P P P P Note 1,2,4,5,6
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

Operator’s Manual J-5

J Indications for Use

Transducer: L9-3s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
Doppler Doppler (specify)
Ophthalmic Ophthalmic
Fetal Imaging& Fetal
Other Abdominal P P P P P P Note 1,2,5
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P Note 1,2,5
Small Organ (Specify**) P P P P P P Note 1,2,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal P P P P P P Note 1,2,5
(Conventional)
Musculo-skeletal P P P P P P Note 1,2,5
(Superficial)
Intravascular
Thoracic/Pleural
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel P P P P P P Note 1,2,5
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

J-6 Operator’s Manual

 J Indications for Use

Transducer: V11-3Hs
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
1 Only) Doppler Doppler (specify)
Ophthalmic Ophthalmic
Fetal Imaging& Fetal P P P P P P Note 1,2,4,5
Other Abdominal
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify**)
Neonatal Cephalic
Adult Cephalic
Trans-rectal P P P P P P Note 1,2,4,5,6
Trans-vaginal P P P P P P Note 1,2,4,5,6
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Thoracic/Pleural
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel
vessel Other (Specify***) P P P P P P Note 1,2,4,5,6
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

Operator’s Manual J-7

J Indications for Use

Transducer: L11-3VNs
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
1 Only) Doppler Doppler (specify)
Ophthalmic Ophthalmic
Fetal Imaging& Fetal
Other Abdominal P P P P P P Note 1,2,5
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P Note 1,2,5
Small Organ (Specify**) P P P P P P Note 1,2,5,6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal P P P P P P Note 1,2,5
(Conventional)
Musculo-skeletal P P P P P P Note 1,2,5
(Superficial)
Intravascular
Thoracic/Pleural P P P P P Note 1,2,5
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel P P P P P P Note 1,2,5
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

J-8 Operator’s Manual

 J Indications for Use

Transducer: L12-3VNs
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
1 Only) Doppler Doppler (specify)
Ophthalmic Ophthalmic
Fetal Imaging& Fetal
Other Abdominal P P P P P P Note 1,2,5
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P Note 1,2,5
Small Organ (Specify**) P P P P P P Note 1,2,5,6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal P P P P P P Note 1,2,5
(Conventional)
Musculo-skeletal P P P P P P Note 1,2,5
(Superficial)
Intravascular
Thoracic/Pleural P P P P P Note 1,2,5
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel P P P P P P Note 1,2,5
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

Operator’s Manual J-9

 J Indications for Use

Transducer: L12-3RCs
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
Doppler Doppler (specify)
Ophthalmic Ophthalmic
Fetal Imaging& Fetal
Other Abdominal P P P P P P Note 1,2,5
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P Note 1,2,5
Small Organ (Specify**) P P P P P P Note 1,2,5.6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal P P P P P P Note 1,2,5
(Conventional)
Musculo-skeletal P P P P P P Note 1,2,5
(Superficial)
Intravascular
Thoracic/Pleural P P P P P P Note 1,2,5
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel P P P P P P Note 1,2,5
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

J - 10 Operator’s Manual
 J Indications for Use

Transducer: L13-3s

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
Doppler Doppler (specify)
Ophthalmic Ophthalmic P P P P
Fetal Imaging& Fetal
Other Abdominal P P P P P P Note 1,2,5
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P Note 1,2,5
Small Organ (Specify**) P P P P P P Note 1,2,5,6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal P P P P P P Note 1,2,5
(Conventional)
Musculo-skeletal P P P P P P Note 1,2,5
(Superficial)
Intravascular
Thoracic/Pleural P P P P P Note 1,2,5
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel P P P P P P Note 1,2,5
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

Operator’s Manual J - 11
 J Indications for Use

Transducer: L13-3Ns
Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Use:
Clinical Application Mode of Operation
General Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
(Track Doppler Doppler (specify)
1 Only)
Ophthalmic Ophthalmic P P P P
Fetal Fetal
Imaging& Abdominal P P P P P P Note 1,2,5
Other Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P Note 1,2,5
Small Organ (Specify**) P P P P P P Note 1,2,5,6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal P P P P P P Note 1,2,5
(Conventional)
Musculo-skeletal P P P P P P Note 1,2,5
(Superficial)
Intravascular
Thoracic/Pleural P P P P P Note 1,2,5
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel P P P P P P Note 1,2,5
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

J - 12 Operator’s Manual
 J Indications for Use

Transducer: L14-6Ns
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
Doppler Doppler (specify)
Ophthalmic Ophthalmic P P P P
Fetal Imaging& Fetal
Other Abdominal P P P P P P Note 1,2,5
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P Note 1,2,5
Small Organ (Specify**) P P P P P P Note 1,2,5,6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal P P P P P P Note 1,2,5
(Conventional)
Musculo-skeletal P P P P P P Note 1,2,5
(Superficial)
Intravascular
Thoracic/Pleural P P P P P Note 1,2,5
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel P P P P P P Note 1,2,5
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

Operator’s Manual J - 13
 J Indications for Use

Transducer: L16-4Hs
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
Doppler Doppler (specify)
Ophthalmic Ophthalmic
Fetal Imaging& Fetal
Other Abdominal P P P P P P Note 1,2,5
Intra-operative (Specify*) P P P P P P Note 1,2,5
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P Note 1,2,5
Small Organ (Specify**) P P P P P P Note 1,2,5
Neonatal Cephalic P P P P P P Note 1,2,5
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal P P P P P P Note 1,2,5
(Conventional)
Musculo-skeletal P P P P P P Note 1,2,5
(Superficial)
Intravascular
Thoracic/Pleural
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel P P P P P P Note 1,2,5
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

J - 14 Operator’s Manual
 J Indications for Use

Transducer: L20-5s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
Doppler Doppler (specify)
Ophthalmic Ophthalmic P P P P
Fetal Imaging& Fetal
Other Abdominal
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P Note 1,2,5
Small Organ (Specify**) P P P P P P Note 1,2,5,6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal P P P P P P Note 1,2,5,6
(Conventional)
Musculo-skeletal P P P P P P Note 1,2,5,6
(Superficial)
Intravascular
Thoracic/Pleural
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel P P P P P P Note 1,2,5
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

Operator’s Manual J - 15
 J Indications for Use

Transducer: P4-2s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
1 Only) Doppler Doppler (specify)
Ophthalmic Ophthalmic
Fetal Imaging& Fetal
Other Abdominal P P P P P P P Note 1,2,4,5
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P P Note 1,2,4,5
Small Organ (Specify**)
Neonatal Cephalic P P P P P P P Note 1,2,4,5
Adult Cephalic P P P P P P P Note 1,2,4,5
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Thoracic/Pleural P P P P P Note 1,2,4,5
(Specify****)
Cardiac Cardiac Adult P P P P P P P Note 1,2,3,4,5,7
Cardiac Pediatric P P P P P P P Note 1,2,3,4,5
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

J - 16 Operator’s Manual
 J Indications for Use

Transducer: SP5-1Ns
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
1 Only) Doppler Doppler (specify)
Ophthalmic Ophthalmic
Fetal Imaging& Fetal
Other Abdominal P P P P P P P Note 1,2,4,5
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P P Note 1,2,4,5
Small Organ (Specify**)
Neonatal Cephalic P P P P P P P Note 1,2,4,5
Adult Cephalic P P P P P P P Note 1,2,4,5
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Thoracic/Pleural P P P P P Note 1,2,4,5
(Specify****)
Cardiac Cardiac Adult P P P P P P P Note 1,2,3,4,5,7
Cardiac Pediatric P P P P P P P Note 1,2,3,4,5
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

Operator’s Manual J - 17
 J Indications for Use

Transducer: P7-3Ts
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
1 Only) Doppler Doppler (specify)
Ophthalmic Ophthalmic
Fetal Imaging& Fetal
Other Abdominal
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify**)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Thoracic/Pleural
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac) P P P P P P P Note1,3,4
Intra-cardiac
Peripheral Peripheral vessel
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

J - 18 Operator’s Manual
 J Indications for Use

Transducer: P8-3Ts
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
1 Only) Doppler Doppler (specify)
Ophthalmic Ophthalmic
Fetal Imaging& Fetal
Other Abdominal
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify**)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Thoracic/Pleural
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac) P P P P P P P Note1,3,4
Intra-cardiac
Peripheral Peripheral vessel
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

Operator’s Manual J - 19
 J Indications for Use

Transducer: P10-4s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
1 Only) Doppler Doppler (specify)
Ophthalmic Ophthalmic
Fetal Imaging& Fetal
Other Abdominal P P P P P P P Note1,4,5
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P P Note1,4,5
Small Organ (Specify**)
Neonatal Cephalic P P P P P P P Note1,4,5
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Thoracic/Pleural
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric P P P P P P P Note1,3,4,5
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

J - 20 Operator’s Manual
 J Indications for Use

Transducer: C5-2s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
Doppler Doppler (specify)
Ophthalmic Ophthalmic
Fetal Imaging& Fetal P P P P P P Note 1,2,4,5
Other Abdominal P P P P P P Note 1,2,4,5,8
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P Note 1,2,4,5
Small Organ (Specify**)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal P P P P P P
(Conventional) Note 1,2,4,5

Musculo-skeletal
(Superficial)
Intravascular
Thoracic/Pleural
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel P P P P P P Note 1,2,4,5
vessel Other (Specify***) P P P P P P Note 1,2,4,5
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

Operator’s Manual J - 21
 J Indications for Use

Transducer: L12-4s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
1 Only) Doppler Doppler (specify)
Ophthalmic Ophthalmic P P P P
Fetal Imaging& Fetal
Other Abdominal P P P P P P Note 1,2,5
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P Note 1,2,5
Small Organ (Specify**) P P P P P P Note 1,2,5,6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal Note 1,2,5
P P P P P P
(Conventional)
Musculo-skeletal Note 1,2,5
P P P P P P
(Superficial)
Intravascular
Thoracic/Pleural Note 1,2,5
P P P P P
(Specify****)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel P P P P P P Note 1,2,5
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

J - 22 Operator’s Manual
 J Indications for Use

Transducer: P8-2s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
1 Only) Doppler Doppler (specify)
Ophthalmic Ophthalmic
Fetal Imaging& Fetal
Other Abdominal P P P N P P P Note 1,3,4,5
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P N P P P Note 1,3,4,5
Small Organ (Specify**)
Neonatal Cephalic P P P N P P P Note 1,3,4,5
Adult Cephalic P P P N P P P Note 1,3,4,5
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal Note 1,3,4,5
P P P P P P
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Thoracic/Pleural
(Specify****)
Cardiac Cardiac Adult P P P N P P P Note 1,3,4,5
Cardiac Pediatric P P P N P P P Note 1,3,4,5
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

Operator’s Manual J - 23
 J Indications for Use

Transducer: CW2s
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track Specific (Track 1 & 3) B M PWD CWD Color Amplitude Combined Other (specify)
1 Only) Doppler Doppler (specify)
Ophthalmic Ophthalmic
Fetal Imaging& Fetal
Other Abdominal
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric P
Small Organ (Specify**)
Neonatal Cephalic
Adult Cephalic P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Thoracic/Pleural
(Specify****)
Cardiac Cardiac Adult P
Cardiac Pediatric P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral Peripheral vessel P
vessel Other (Specify***)
N=new indication ˗ P=previously cleared by FDA ˗ E=added under Appendix E
Additional comments˖Combined modes--B+Mǃ PW+Bǃ Color + Bǃ Power + Bǃ PW +Color+ Bǃ Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)

J - 24 Operator’s Manual
P/N: 046-018839-01 (5.0)