VS-900

Vital Signs Monitor

Operator’s Manual
© Copyright 2013-2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights
reserved.

Release date: April 2016.

Revision: 7.0

I
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 copyrights or patents and does not convey
any license under the patent rights of Mindray, nor the rights 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, adaption and translation of this

manual in any manner whatsoever without the written permission of Mindray is strictly
forbidden.

, , and are the registered trademarks or trademarks

owned by Mindray in China and other countries. All other trademarks that appear in this
manual are used only for editorial purposes without the intention of improperly using
them. They are the property of their respective owners.

Responsibility on the Manufacturer Party

Contents of this manual are subject to changes without prior notice.

All information contained in this manual is believed to be correct. Mindray shall not be
liable for errors contained herein nor 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;
 the product is used in accordance with the instructions for use.

WARNING
 This equipment must be operated by skilled/trained clinical professionals.
 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.

II
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.

Company Contact
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address Mindray Building, Keji 12th Road South, Hi-tech industrial
park, Nanshan, Shenzhen 518057, P.R.China
Website www.mindray.com
E-mail Address: service@mindray.com.cn

Tel: +86 755 81888998

Fax: +86 755 26582680

EC-Representative: Shanghai International Holding Corp. GmbH (Europe)

Address: Eiffestraβe 80, 20537 Hamburg, Germany

Tel: 0049-40-2513175
Fax: 0049-40-255726

III
Preface
Manual Purpose
This manual contains the instructions necessary to operate the product safely and in
accordance with its function and intended use. Observance of this manual is a
prerequisite for proper product performance and correct operation and ensures patient
and operator safety.

This manual is based on the maximum configuration and therefore some contents may
not apply to your product. If you have any question, please contact us.

This manual is an integral part of the product. It should always be kept close to the
equipment so that it can be obtained conveniently when needed.

Intended Audience
This manual is geared for clinical professionals who are expected to have corresponding
working knowledge of medical procedures, practices and terminology as required for
monitoring of patients.

Illustrations
All illustrations in this manual serve as examples only. They may not necessarily reflect the
setup or data displayed on your equipment.

Conventions
 Italic text is used in this manual to quote the referenced chapters or sections.
 [ ] is used to enclose screen texts.
 → is used to indicate operational procedures.

IV
Contents

1 Safety...................................................................................................................................... 1-1
1.1 Safety Information....................................................................................................................................... 1-1 
1.1.1 Warnings ............................................................................................................................................ 1-1 
1.1.2 Cautions ............................................................................................................................................. 1-3 
1.1.3 Notes ................................................................................................................................................... 1-4 
1.2 Equipment Symbols ................................................................................................................................... 1-5 
2 The Basics ............................................................................................................................... 2-1 
2.1 Intended Use ................................................................................................................................................. 2-1 
2.2 Applied Parts ................................................................................................................................................. 2-1 
2.3 Main unit ......................................................................................................................................................... 2-2 
2.3.1 Front View ......................................................................................................................................... 2-2 
2.3.2 Side View ........................................................................................................................................... 2-4 
2.3.3 Rear View ........................................................................................................................................... 2-5 
2.3.4 Bottom View ..................................................................................................................................... 2-6 
2.4 Main Screen ................................................................................................................................................... 2-7 
2.5 Menu ..............................................................................................................................................................2-10 
2.6 Operating Modes .......................................................................................................................................2-10 
2.6.1 Monitor Mode ................................................................................................................................2-10 
2.6.2 Spot Check Mode .........................................................................................................................2-11 
2.6.3 Standby Mode ...............................................................................................................................2-11 
2.6.4 Demo Mode....................................................................................................................................2-12 
3 Basic Operations .................................................................................................................... 3-1 
3.1 Installation...................................................................................................................................................... 3-1 
3.1.1 Unpacking and Checking ............................................................................................................ 3-2 
3.1.2 Environmental Requirements.................................................................................................... 3-2 
3.2 General Operation ....................................................................................................................................... 3-3 
3.2.1 Connection to AC Power ............................................................................................................. 3-3 
3.2.2 Using a Battery ................................................................................................................................ 3-3 
3.2.3 Connecting Accessories ............................................................................................................... 3-4 
3.3 Turning On/Off Power ................................................................................................................................ 3-4 
3.3.1 Check before Power On ............................................................................................................... 3-4 
3.3.2 Turning Power On .......................................................................................................................... 3-4 
3.3.3 Turning off the Monitor................................................................................................................ 3-5 
3.4 Using Key, Knob, Touchscreen ................................................................................................................ 3-6 
3.4.1 Using Keys ......................................................................................................................................... 3-6 
3.4.2 Using the Knob................................................................................................................................ 3-6 
3.4.3 Using the Touchscreen ................................................................................................................. 3-6 
3.5 Changing General Settings ...................................................................................................................... 3-6 
3.5.1 Setting up a Monitor ..................................................................................................................... 3-7 
3.5.2 Changing Language ...................................................................................................................... 3-7 
3.5.3 Configuring the Timeout of Clinician ID ................................................................................ 3-7 
3.5.4 Showing/Hiding Patient Name ................................................................................................. 3-7 
3.5.5 Adjusting Alarm Volume.............................................................................................................. 3-7 

1
 3.5.6 Adjusting Key Volume .................................................................................................................. 3-8 
3.5.7 Adjusting the Screen Brightness .............................................................................................. 3-8 
3.5.8 Setting Screen ................................................................................................................................. 3-8 
3.5.9 Configuring the Timeout of Measured Value....................................................................... 3-8 
3.5.10 Configuring Measurement Colors ......................................................................................... 3-9 
3.5.11 Setting the Date and Time........................................................................................................ 3-9 
3.5.12 Configuring Unit .......................................................................................................................... 3-9 
3.5.13 Configuring Printout .................................................................................................................. 3-9 
3.5.14 Selecting a Central Monitoring System ............................................................................... 3-9 
3.5.15 Clearing the Selected CMS at Startup .................................................................................. 3-9 
4 Patient Data Management .................................................................................................... 4-1 
4.1 Admitting a Patient ..................................................................................................................................... 4-1 
4.1.1 Admitting a Patient by the Admit Patient Hardkey ........................................................... 4-1 
4.1.2 Admitting a Patient by Barcode Scanner .............................................................................. 4-2 
4.1.3 Admitting a Patient from [Patient List]................................................................................... 4-4 
4.2 Manually Input Patient Data.................................................................................................................... 4-5 
4.3 Manually Save Patient Data ..................................................................................................................... 4-6 
4.4 Reviewing Patient Data ............................................................................................................................. 4-7 
4.4.1 Spot Check Trends ......................................................................................................................... 4-7 
4.4.2 Continuous Trends ......................................................................................................................... 4-8 
4.4.3 Graphic Trends................................................................................................................................. 4-9 
4.5 Transferring Data from the Monitor to USB Drive .........................................................................4-10 
5 Managing Configurations ..................................................................................................... 5-1 
5.1 Overview ......................................................................................................................................................... 5-1 
5.2 Accessing [Manage Configuration] Menu.......................................................................................... 5-1 
5.2.1 Setting Default Configuration ................................................................................................... 5-2 
5.3 Saving Current Settings............................................................................................................................. 5-2 
5.4 Deleting a Configuration .......................................................................................................................... 5-2 
5.5 Transferring a Configuration ................................................................................................................... 5-3 
5.6 Loading a Configuration ........................................................................................................................... 5-3 
5.7 Restoring the Latest Configuration Automatically ......................................................................... 5-4 
6 Alarms .................................................................................................................................... 6-1 
6.1 Alarm Categories ......................................................................................................................................... 6-1 
6.2 Alarm Levels................................................................................................................................................... 6-2 
6.3 Alarm Indicators ........................................................................................................................................... 6-2 
6.3.1 Alarm Lamp ...................................................................................................................................... 6-2 
6.3.2 Audible Alarm Tones ..................................................................................................................... 6-3 
6.3.3 Alarm Messages .............................................................................................................................. 6-3 
6.3.4 Flashing Numerics.......................................................................................................................... 6-4 
6.3.5 Alarm Status Symbols ................................................................................................................... 6-4 
6.4 Setting Alarms .............................................................................................................................................. 6-4 
6.5 Selecting Alarm Properties ...................................................................................................................... 6-5 
6.5.1 Changing the Alarm Volume...................................................................................................... 6-5 
6.5.2 Setting the Minimum Alarm Volume ...................................................................................... 6-5 
6.5.3 Setting the Interval between Alarm Sounds ....................................................................... 6-5 
6.5.4 Adjusting Alarm Limits Automatically.................................................................................... 6-6 

2
 6.6 Pausing Alarms ............................................................................................................................................. 6-8 
6.7 Switching Off Alarm Sound ..................................................................................................................... 6-8 
6.8 Resetting Alarms .......................................................................................................................................... 6-8 
6.9 Setting the Reminder Tone ...................................................................................................................... 6-9 
6.10 Latching Alarms .......................................................................................................................................6-10 
6.11 Actions for Alarm Occurrence ............................................................................................................6-10 
6.12 Nurse Call ...................................................................................................................................................6-11 
7 Monitoring SpO2 .................................................................................................................... 7-1 
7.1 Overview ......................................................................................................................................................... 7-1 
7.2 Safety ................................................................................................................................................................ 7-2 
7.3 Identifying SpO2 Module .......................................................................................................................... 7-2 
7.4 Applying the Sensor ................................................................................................................................... 7-3 
7.5 Changing SpO2 Settings............................................................................................................................ 7-3 
7.5.1 Accessing SpO2 Menu ................................................................................................................... 7-3 
7.5.2 Adjusting the Desat Alarm.......................................................................................................... 7-3 
7.5.3 Setting SpO2 Sensitivity ............................................................................................................... 7-4 
7.5.4 Changing Averaging Time .......................................................................................................... 7-4 
7.5.5 Monitoring SpO2 and NIBP Simultaneously ......................................................................... 7-4 
7.5.6 Sat-Seconds Alarm Management ............................................................................................ 7-4 
7.5.7 Changing the Speed of Pleth Wave ......................................................................................... 7-6 
7.5.8 Setting the Alarm Level for SpO2 Sensor Off Alarm .......................................................... 7-6 
7.6 Measurement Limitations ........................................................................................................................ 7-6 
7.7 Masimo Information ................................................................................................................................... 7-7 
7.8 Nellcor Information..................................................................................................................................... 7-7 
8 Monitoring PR ........................................................................................................................ 8-1 
8.1 Overview ......................................................................................................................................................... 8-1 
8.2 PR Source ........................................................................................................................................................ 8-1 
8.3 Pulse Tone ....................................................................................................................................................... 8-1 
9 Monitoring NIBP .................................................................................................................... 9-1 
9.1 Overview ......................................................................................................................................................... 9-1 
9.2 Safety ................................................................................................................................................................ 9-2 
9.3 Measurement Limitations ........................................................................................................................ 9-3 
9.4 NIBP Measurement Mode......................................................................................................................... 9-3 
9.5 Measuring NIBP ............................................................................................................................................ 9-4 
9.5.1 Preparing the Patient .................................................................................................................... 9-4 
9.5.2 Preparation to Measure NIBP ..................................................................................................... 9-4 
9.5.3 Starting NIBP measurement....................................................................................................... 9-5 
9.5.4 Stopping NIBP Measurement .................................................................................................... 9-5 
9.5.5 Correcting the Measurement if Limb is not at Heart Level ............................................ 9-5 
9.6 Understanding the NIBP Numerics ....................................................................................................... 9-6 
9.7 Setting NIBP ................................................................................................................................................... 9-6 
9.7.1 Setting Interval ................................................................................................................................ 9-6 
9.7.2 Setting the Initial Cuff Inflation Pressure............................................................................... 9-6 
9.7.3 Setting NIBP End Tone .................................................................................................................. 9-7 
9.7.4 Switching On/Off Measurement on Clock ............................................................................ 9-7 
9.7.5 Configuring a Custom Program ................................................................................................ 9-7 

3
 9.7.6 Setting NIBP Alarm Properties .................................................................................................. 9-8 
9.7.7 Setting the Pressure Unit............................................................................................................. 9-8 
9.8 Assisting Venous Puncture ....................................................................................................................... 9-9 
10 Monitoring Temp ............................................................................................................... 10-1 
10.1 Monitoring Temp with SmarTemp™ Module ................................................................................10-1 
10.1.1 Setting Temp................................................................................................................................10-2 
10.1.2 Measuring Temp.........................................................................................................................10-2 
10.1.3 Disinfecting Temperature Probe ..........................................................................................10-4 
10.2 Monitoring Temp with THP79JU Infrared Ear Thermometer ..................................................10-5 
10.2.1 Measuring Temperature ..........................................................................................................10-5 
10.2.2 Understanding the Numerics................................................................................................10-8 
10.2.3 Troubleshooting .........................................................................................................................10-9 
10.2.4 Cleaning and Disinfecting the Ear Thermometer ..........................................................10-9 
10.3 Monitoring Temp with GeniusTM 2 Tympanic Thermometer...................................................10-9 
10.3.1 Safety Information .....................................................................................................................10-9 
10.3.2 Thermometer Buttons........................................................................................................... 10-10 
10.3.3 Equivalence Mode Temperature ....................................................................................... 10-10 
10.3.4 Taking an Temperature ......................................................................................................... 10-11 
10.3.5 Temperature Display .............................................................................................................. 10-12 
10.3.6 Troubleshooting ...................................................................................................................... 10-12 
10.3.7 Cleaning and Disinfecting the Tympanic Thermometer .......................................... 10-12 
11 Monitoring CO2 .................................................................................................................. 11-1 
11.1 Overview ....................................................................................................................................................11-1 
11.2 Safety ...........................................................................................................................................................11-1 
11.3 Measurement Limitations ....................................................................................................................11-1 
11.4 CO2 Display ................................................................................................................................................11-2 
11.5 Measuring CO2..........................................................................................................................................11-2 
11.6 Automatic CO2 Module Zeroing ........................................................................................................11-4 
11.7 Changing CO2 Settings..........................................................................................................................11-4 
11.7.1 Changing CO2 Alarm Settings ...............................................................................................11-4 
11.7.2 Setting the Apnea Alarm Delay ............................................................................................11-4 
11.7.3 Setting the CO2 Waveform ......................................................................................................11-4 
11.7.4 Entering the Standby Mode...................................................................................................11-5 
11.7.5 Setting the Auto Standby .......................................................................................................11-5 
11.7.6 Setting Humidity Compensation .........................................................................................11-5 
11.7.7 Setting Gas Compensation ....................................................................................................11-6 
11.7.8 Automatic Barometric Pressure ............................................................................................11-6 
11.7.9 Calibrating the CO2 Module ...................................................................................................11-6 
12 Clinical Scoring .................................................................................................................. 12-1 
12.1 Overview ....................................................................................................................................................12-1 
12.1.1 MEWS (Modified Early Warning Score) ..............................................................................12-1 
12.1.2 NEWS (National Early Warning Score) ................................................................................12-1 
12.1.3 Customizable Scoring ..............................................................................................................12-2 
12.2 Entering the Calculation Screen ........................................................................................................12-2 
12.2.1 Scoring Screen ............................................................................................................................12-2 
12.2.2 Score Tile .......................................................................................................................................12-3 

4
 12.3 Calculating a Score .................................................................................................................................12-3 
12.4 Clinical Scoring Screen ..........................................................................................................................12-3 
12.4.1 Score Tile in the Main Screen ................................................................................................12-3 
12.4.2 Scoring Screen ............................................................................................................................12-4 
12.5 Obtaining the Total Score ....................................................................................................................12-5 
12.6 Managing Scorings.................................................................................................................................12-7 
12.6.1 Importing the Scoring .............................................................................................................12-7 
12.6.2 Selecting Default Scoring .......................................................................................................12-7 
12.6.3 Deleting the Scoring.................................................................................................................12-7 
12.6.4 Loading a Scoring ......................................................................................................................12-7 
13 Recording ........................................................................................................................... 13-1 
13.1 Using a Recorder .....................................................................................................................................13-1 
13.2 Loading Paper ..........................................................................................................................................13-1 
13.3 Setting the Recorder ..............................................................................................................................13-2 
13.4 Starting and Stopping Recordings ...................................................................................................13-2 
13.5 Reports ........................................................................................................................................................13-3 
13.5.1 Real-time Recording .................................................................................................................13-3 
13.5.2 Graphic Trend Recording ........................................................................................................13-3 
13.5.3 Continuous Trends Recording...............................................................................................13-3 
13.5.4 Spot Check Trends Recording ...............................................................................................13-4 
13.6 Removing Paper Jam .............................................................................................................................13-4 
13.7 Cleaning the Recorder Printhead......................................................................................................13-4 
14 Network .............................................................................................................................. 14-1 
14.1 Network Connection..............................................................................................................................14-1 
14.2 Network Type and Settings .................................................................................................................14-1 
14.2.1 Wireless Network .......................................................................................................................14-2 
14.2.2 WLAN Test .....................................................................................................................................14-2 
14.3 Setting Data Send Method ..................................................................................................................14-3 
14.3.1 ADT Communication Setup ...................................................................................................14-3 
14.3.2 EMR Communication Setup...................................................................................................14-3 
14.3.3 NTP Server Setup .......................................................................................................................14-3 
14.3.4 Realtime Date Send Interval (for HL7 only)......................................................................14-4 
14.3.5 Alarm Server Setup (for HL7 only) .......................................................................................14-4 
14.4 Connecting the monitor to the CMS ...............................................................................................14-4 
14.4.1 Setting the CMS ..........................................................................................................................14-5 
14.4.2 Selecting a CMS ..........................................................................................................................14-5 
14.4.3 Clearing the Selected CMS at Startup ................................................................................14-5 
14.5 Certificates Maintenance .....................................................................................................................14-5 
14.6 Setting the Multicast Parameters ......................................................................................................14-6 
14.7 DIAP Communication Setup ...............................................................................................................14-6 
15 Battery ................................................................................................................................ 15-1 
15.1 Overview ....................................................................................................................................................15-1 
15.2 Charging a Battery ..................................................................................................................................15-2 
15.3 Replacing a Battery.................................................................................................................................15-2 
15.4 Battery Guidelines ..................................................................................................................................15-2 
15.5 Battery Maintenance .............................................................................................................................15-3 

5
 15.5.1 Conditioning a Battery.............................................................................................................15-3 
15.5.2 Checking a Battery ....................................................................................................................15-3 
15.6 Recycling a Battery .................................................................................................................................15-4 
16 Care and Maintenance ...................................................................................................... 16-1 
16.1 Cleaning and Disinfection ...................................................................................................................16-1 
16.1.1 Cleaning ........................................................................................................................................16-2 
16.1.2 Disinfecting ..................................................................................................................................16-3 
16.2 General Inspection .................................................................................................................................16-3 
16.3 Maintenance and Testing Schedule .................................................................................................16-3 
16.4 Checking Monitor Information ..........................................................................................................16-5 
16.5 NIBP Test .....................................................................................................................................................16-6 
16.5.1 NIBP Leakage Test ......................................................................................................................16-6 
16.5.2 NIBP Accuracy Test ....................................................................................................................16-7 
16.6 CO2 Test .......................................................................................................................................................16-8 
16.6.1 CO2 Leakage Test ........................................................................................................................16-8 
16.6.2 CO2 Accuracy Test ......................................................................................................................16-8 
16.6.3 Calibrating CO2 ...........................................................................................................................16-9 
16.7 Calibrating the Touchscreen ............................................................................................................ 16-10 
16.8 Formatting the Storage Card ........................................................................................................... 16-10 
16.9 Modifying Password............................................................................................................................ 16-10 
17 Accessories ......................................................................................................................... 17-1 
17.1 SpO2 Accessories .....................................................................................................................................17-1 
17.2 NIBP Accessories ......................................................................................................................................17-3 
17.3 Temp Accessories ....................................................................................................................................17-4 
17.3.1 SmarTemp™ Accessories .........................................................................................................17-4 
17.3.2 THP79JU Ear Thermometer Accessories ............................................................................17-5 
17.3.3 GeniusTM 2 Tympanic Thermometer Accessories............................................................17-5 
17.4 CO2 Accessories ........................................................................................................................................17-5 
A Product Specifications .......................................................................................................... A-1 
A.1 Classifications ..............................................................................................................................................A-1 
A.2 Environmental Specifications ................................................................................................................A-1 
A.3 Power Supply Specifications ..................................................................................................................A-2 
A.4 Physical Specifications .............................................................................................................................A-3 
A.5 Hardware Specifications ..........................................................................................................................A-3 
A.6 Measurement Specifications..................................................................................................................A-4 
B EMC and Radio Regulatory Compliance .............................................................................. B-1 
B.1 EMC .................................................................................................................................................................. B-1 
B.2 Radio Regulatory Compliance............................................................................................................... B-6 
C Default Configurations ......................................................................................................... C-1 
C.1 Parameter Configuration......................................................................................................................... C-1 
C.2 General configuration .............................................................................................................................. C-5 
C.3 User Maintenance Items.......................................................................................................................... C-6 
D Alarm Messages .................................................................................................................... D-1 

6
 D.1 Physiological Alarm Messages ............................................................................................................. D-1 
D.2 Technical Alarm Messages ..................................................................................................................... D-1 
E Electrical Safety Inspection .................................................................................................. E-1 
E.1 Power Cord Plug ......................................................................................................................................... E-1 
E.2 Device Enclosure and Accessories ....................................................................................................... E-2 
E.3 Device Labeling .......................................................................................................................................... E-2 
E.4 Protective Earth Resistance .................................................................................................................... E-2 
E.5 Earth Leakage Test ..................................................................................................................................... E-3 
E.6 Patient Leakage Current .......................................................................................................................... E-3 
E.7 Mains on Applied Part Leakage ............................................................................................................ E-4 
F Symbols and Abbreviations .................................................................................................. F-1 
F.1 Symbols .......................................................................................................................................................... F-1 
F.2 Abbreviations ............................................................................................................................................... F-3

7
FOR YOUR NOTES

8
1 Safety

1.1 Safety Information

WARNING
 Indicates a potential hazard situation or unsafe practice that, if not avoided,
could result in death or serious injury.

CAUTION
 Indicates a potential hazard or unsafe practice that, if not avoided, could result
in minor personal injury or product/property damage.

NOTE

 Provides application tips or other useful information to ensure that you get the
most from your product.

1.1.1 Warnings

WARNING
 This equipment is used for single patient at a time.
 Before putting the system into operation, the operator must verify that the
equipment, connecting cables and accessories are in correct working order and
operating condition.
 To avoid risk of electric shock, this equipment must only be connected to a
supply mains with protective earth. If the installation does not provide for a
protective earth conductor, disconnect it from the power line and operate it on
battery power, if possible.
 Ensure that the patient monitor is supplied with continuous electric power
during work. Sudden power failure leads to the loss of patient data.
 To avoid explosion hazard, do not use the equipment in the presence of oxygen
---rich atmospheres, flammable anesthetics, or other flammable agents (such as
gasoline).

1-1
 Do not open the equipment housings. All servicing and future upgrades must
be carried out by the personnel trained and authorized by our company only.
 Do not come into contact with patients during defibrillation. Otherwise serious
injury or death could result.
 Do not touch the equipment’s metal parts or connectors when in contact with
the patient; otherwise patient injury may result.
 Do not rely exclusively on the audible alarm system for patient monitoring.
Adjustment of alarm volume to a low level or off may result in a hazard to the
patient. Remember that alarm settings should be customized according to
different patient situations and always keeping the patient under close
surveillance is the most reliable way for safe patient monitoring.
 The physiological data and alarm messages displayed on the equipment are for
reference only and cannot be directly used for diagnostic interpretation and
replace the competent judgment of a clinician.
 To avoid inadvertent disconnection, route all cables in a way to prevent a
stumbling hazard. Wrap and secure excess cabling to reduce risk of
entanglement or strangulation by patients or personnel.
 When disposing of the packaging material, be sure to observe the applicable
waste control regulations and keep it out of children’s reach.
 When no battery is installed, make sure that the power supply is continuous. A
power interruption will result in patient data loss.
 Put the equipment in a location where you can easily see the screen, access the
operating controls, and disconnect the equipment from AC power.
 The equipment uses a mains plug as isolation means to the mains power supply.
Please do not position the equipment in a place difficult to operate the mains
plug.
 The equipment is not intended to be used within the magnetic resonance (MR)
environment.

1-2
1.1.2 Cautions

CAUTION
 Use only parts and accessories specified in this manual.
 Remove the battery before shipping the monitor or if it will not be used for an
extended period of time.
 Carefully route patient cabling to reduce the possibility of patient
entanglement or strangulation.
 Disposable accessories are not designed to be reused. Reuse may cause a risk of
contamination and affect the measurement accuracy.
 At the end of its service life, the equipment, as well as its accessories, must be
disposed of in compliance with the guidelines regulating the disposal of such
products. If you have any questions concerning disposal of the equipment,
please contact Mindray.
 Magnetic and electrical fields are capable of interfering with the proper
performance of the equipment. For this reason, make sure that all external
devices operated in the vicinity of the equipment comply with the relevant EMC
requirements. Mobile phone, X-ray equipment or MRI devices are a possible
source of interference as they may emit higher levels of electromagnetic
radiation.
 Before connecting the equipment to the power line, check that the voltage and
frequency ratings of the power line are the same as those indicated on the
equipment’s label or in this manual.
 Always install or carry the equipment properly to avoid damage caused by
drop, impact, strong vibration or other mechanical force.
 If you spill liquid on the equipment or accessories, contact us or your service
personnel.

1-3
1.1.3 Notes

NOTE

 Put the equipment in a location where you can easily view and operate the
equipment.Keep this manual in the vicinity of the equipment so that it can be
obtained conveniently when needed.
 The software was developed in compliance with IEC60601-1. The possibility of
hazards arising from software errors is minimized.
 This manual describes all features and options. Your equipment may not have
all of them.
 During normal use, the operator is expected to face the front of the equipment.
 The equipment uses a mains plug as a means of isolation to the mains power
supply. Do not position the equipment in a place difficult to access the mains
plug.
 Only the central monitoring system with a software version 06.08.00 or greater,
or the eGateway with a software version 5.0 or greater, supports VS-900
monitor.

1-4
1.2 Equipment Symbols
Some symbols may not appear on your equipment.

ON/OFF for a part of

General warning sign
equipment

Alternating current Battery indicator

Alarm Reset NIBP Start/Stop key

ALARM PAUSED Graphical recorder

Admit patient Insertion Direction

DEFIBRILLATION ---PROOF
Input/Output
TYPE CF APPLIED PART

DEFIBRILLATION-PROOF
Equipotentiality
TYPE BF APPLIED PART

USB connector MANUFACTURER

Serial number DATE OF MANUAFACTURE

AUTHORISED
Protection against fluid
REPRESENTATIVE IN THE
ingress
EUROPEAN COMMUNITY

CATALOGUE NUMBER Humidity limitation

Atmospheric pressure
Temperature limit
limitation

Interference may occur in

Refer to instruction
the vicinity of equipment
manual/booklet
marked with this symbol

Gas outlet Gas sample inlet

1-5
Network connector

The product bears CE mark indicating its conformity with the provisions of
the Council Directive 93/42/EEC concerning medical devices and fulfils the
essential requirements of Annex I of this directive.
Note: The product complies with the Council Directive 2011/65/EU.
The following definition of the WEEE label applies to EU member states only.
This symbol indicates that this product should not be treated as household
waste. By ensuring that this product is disposed of correctly, you will help
prevent bringing potential negative consequences to the environment and
human health. For more detailed information with regard to returning and
recycling this product, please consult the distributor from whom you
purchased it.
* For system products, this label may be attached to the main unit only.

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2 The Basics

2.1 Intended Use

The Monitor is intended for monitoring physiologic parameters, including SpO2, PR, NIBP,
TEMP, and CO2 on adult, pediatric, and neonatal patients in healthcare facilities by clinical
physicians or appropriate medical staff under the direction of physicians.

WARNING
 This equipment is intended for use only by clinical professionals or under their
guidance. It must only be used by persons who have received adequate training
in its use. Anyone unauthorized or untrained must not perform any operation
on it.

2.2 Applied Parts

The applied parts of the monitor include followings:
 SpO2 sensor and cable
 NIBP tubing and cuff
 Temp probes and cable
 CO2 sample line

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2.3 Main unit
2.3.1 Front View

(1)

(2)

(3)

(4)

(5)

(6) (7) (8) (9) (10)

(1) Alarm indicator

When a physiological alarm or a technical alarm occurs, this indicator will flash as
defined below.
 High priority alarm: the lamp quickly flashes red.
 Medium priority alarm: the lamp slowly flashes yellow.
 Low priority alarm: the lamp is yellow without flashing.
(2) Display screen
(3) Temperature module and base
The monitor can be configured with any one of the following modules.
 SmarTempTM module: measures predictive temperature.
 THP79JU module: measures ear temperature.
 GeniusTM 2 module: measures tympatic tempearature.
The temperature module varies in appearance. The above figure shows the main unit
with the SmarTempTM module.
(4) AC power indicator
 On: indicates that the monitor is connected to the AC power.
 Off: indicates that the monitor is not connected to the AC power.
(5) Power ON/OFF switch

2-2
  Press this key to turn the monitor on.
 If no parameter is being measured, press this key to enter Standby mode.
 When the monitor is on, press and hold this key for above 2 seconds to turn the
monitor off.
An indicator is built in this switch. It turns on when the monitor is on and turns off
when the monitor is off.
(6) Battery indicator
 On: indicates that the battery is installed and AC power is connected.
 Off: indicates that the battery is not installed.
 Flash: indicates that the monitor is powered by battery.
(7) Alarm Reset key
 Press this key to disable the audio of present alarms.
 Press and hold this key for more than 2 seconds to pause or restore alarms.
(8) NIBP Start/Stop key
Press to start or stop NIBP measurements.
(9) Admit patient key
 Press this key to admit a new patient.
 Press this key to return to the main screen.
(10) Knob
 Rotate the knob clockwise or counterclockwise to move the cursor.
 Press the knob to select one item, such as accessing a menu or confirming the
selection.

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2.3.2 Side View

(1)

(2)

(3)
(10)
(4)

(5)

CO2

NIB P
SpO2
(9)
(6) !

(7) (8)

(1) Handle
(2) Recorder indicator
(3) Start/stop recording key
(4) Paper outlet
(5) Recorder door
(6) Connector for NIBP cuff
(7) Connector for SpO2 cable
(8) CO2 gas outlet
(9) CO2 sample line connector
(10) Recorder latch

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2.3.3 Rear View

(1)
(3)

(4)
(2)
(5)

(6)

(7)

(1) Temperature probe well

The temperature module varies in appearance. The above figure shows the main unit
with the SmarTempTM module.
(2) Connector for temperature probe
The temperature module varies in appearance. The above figure shows the main unit
with the SmarTempTM module.
(3) Network connector: It is a standard RJ45 connector used to communicate with
external devices, such as central monitoring system, Gateway, or upgrade the system.
(4) Multi-function connector: connects to the hospital's nurse call system, or connects
external devices through DIAP protocol.
(5) USB connector: connects to barcode scanner or USB disk.
(6) AC power input
(7) Equipotential grounding terminal
When the equipment and other devices are to be used together, their equipotential
grounding terminals should be connected together to eliminate the potential
difference between them.

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2.3.4 Bottom View

(1)

(2)

(1) Battery compartment door

(2) Hole for installing a support

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2.4 Main Screen
There are three display modes of main screen. They are all parameter screen, trend screen
and NIBP list screen.

 All Parameter Screen

(1) (8) (7)

(6)
(2)

(3)

(4)

(5)

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 Trend Screen (1) (8) (7)

(6)
(2)

(3)

(9)

(5)
 NIBP List Screen
(1) (8) (7)

(6)
(2)

(3)

(10)

(5)
(1) Patient Information/System Message Area

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 This area normally shows patient information, such as patient medical record number,
patient name, patient category, room, bed number, clinician ID.
When a system related message is presented, the second line of this area will display
the system prompt message for 30 seconds. The patient information there will be
covered temporarily.
(2) Alarm Information Area
There are three sections in this area: The left side of this area shows the technical
alarm message or prompt message; the middle area shows the physiological alarm
message; and the right side of this area shows the alarm symbol.

indicates alarms are paused.

indicates alarms are reset.

indicates alarm sounds are turned off.

(3) Parameter and waveform area: displays parameters and waveforms.
(4) Manual input area: manually input physiological related value. This area does not
display by default. Refer to 4.2 Manually Input Patient Data for additional
information.
(5) Menu QuickKeys
 Main: Accesses the [Main] screen to configure the monitor, or quickly returns to
the main screen.
 Scoring: Accesses the screen to evaluate a patient’s condition. Refer to 12
Clinical Scoring.
 Patient List: Accesses the [Local Patient List] and [ADT Database] screen to
admit a patient stored in the monitor or ADT database. Refer to 4.1.3 Admitting
a Patient from [Patient List].
 Review: Displays the spot check trends, continuous trends and graphic trends.
Refer to 4.4 Reviewing Patient Data.
 Save: Accesses the [Results] screen to manually save patient data. Refer to 4.3
Manually Save Patient Data.
(6) Network and USB connection area
Indicate the connection of network or USB to this monitor.

indicates monitor is connected to a wire network successfully.

indicates the wireless function is working.

indicates monitor has failed to connect a wire network.

indicates the wireless function is not working.

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 indicates a U disk is inserted.

(7) Battery status: indicates the status of the battery. For details, refer to 15 Battery.
(8) System time
(9) Tabular trend area. This area displays only in Trend screen mode.
(10) NIBP list area. This area displays only in NIBP List screen mode.

2.5 Menu

(1) (3)

(2)

A menu in this monitor is usually composed of:

(1) Heading: gives a sum-up for the current menu.
(2) Main body: displays options, buttons, prompt messages, etc. A menu button
followed with ‘‘>>’’ enlarges a secondary window to reveal more options or
information.

(3) : select to exit the current menu.

2.6 Operating Modes

2.6.1 Monitor Mode
The monitor will automatically enter monitor mode after power on. Monitor mode is a

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 common mode for monitoring patient vital signs.

NOTE

 In Monitor mode, physiological and technical alarms, and prompt messages are
supported.

2.6.2 Spot Check Mode

The spot mode is intended for on-spot measurement in a short period. When spot mode
is ON, the message area on the top of screen will display [Spot Check].

To enter Spot Check mode, select [Main]→[Maintenance>>]→[User Settings>>]→Enter

required password→Set [Spot Check] to [On].

NOTE

 In Spot Check mode, technical alarms and prompt messages are supported, but
no physiological alarms.

Monitor Mode vs. Spot Check Mode

The Monitor mode and Spot Check modes have all the features in common except the
following:
Functions Monitor Mode Spot Check Mode
Configure and use Sat-Seconds (Nellcor) Yes No
Access [Alarm Setup] tab Yes No
Access [Continuous Trends] tab Yes No
Access [Graphic Trends] tab Yes No
Connect to the central monitoring system Yes No
Measure CO2 Yes No

2.6.3 Standby Mode

In standby mode, the monitoring for current patient is over, but the monitor still powers
on.

If no parameter is being measured, you can press the power switch to enter Standby
mode. Then a warning pops up. Select [Yes] to enter the Standby mode.

When the monitor is powered by a battery, it will automatically enter the Standby mode
when the following conditions are satisfied:
 No key operation within 10 minutes.
 No unacknowledged alarms.

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 To exit Standby mode, you can take any one of the following ways:
 Press the any hardkey on the panel.
 Rotate the knob.
 Connect SpO2 sensor, and let the monitor receive SpO2 signal for more than 5
seconds.
 Remove the temperature probe from the probe well.

NOTE

 If the monitor enters and then exits Standby mode during patient monitoring,
you must re-admit the patient for the monitoring.

2.6.4 Demo Mode

Demo mode is password protected, and it is used for demonstration purpose only.

To enter Demo mode:

1. Select [Main]→[Maintenance>>].
2. Select [Demo>>]→Enter required password→Select [Ok].

To exit Demo mode:

1. Select [Main]→[Maintenance>>].
2. Select [Exit Demo].

WARNING
 The Demo mode is for demonstration purpose only. To avoid that the simulated
data are mistaken for the monitored patient’s data, you must not change into
Demo mode during monitoring. Otherwise, improper patient monitoring and
delayed treatment could result.

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3 Basic Operations

3.1 Installation

WARNING
 The equipment shall be installed by personnel authorized by us.
 Do not open the equipment housings. All servicing and future upgrades must
be carried out by the personnel trained and authorized by our company only.
 The software copyright of the equipment is solely owned by us. No organization
or individual shall resort to juggling, copying, or exchanging it or to any other
infringement on it in any form or by any means without due permission.
 Devices connected to the equipment must meet the requirements of the
applicable IEC standards (e.g. IEC 60950 safety standards for information
technology equipment and IEC 60601-1 safety standards for medical electrical
equipment). The system configuration must meet the requirements of the IEC
60601-1 medical electrical systems standard. Any personnel who connect
devices to the equipment’s signal input/output port is responsible for providing
evidence that the safety certification of the devices has been performed in
accordance to the IEC 60601-1. If you have any question, please contact us.
 If it is not evident from the equipment specifications whether a particular
combination with other devices is hazardous, for example, due to summation of
leakage currents, please consult the manufacturers or else an expert in the
field, to ensure the necessary safety of patients and all devices concerned will
not be impaired by the proposed combination.

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3.1.1 Unpacking and Checking
Before unpacking, examine the packing case carefully for signs of damage. If any damage
is detected, contact the carrier or us.

If the packing case is intact, open the package and remove the equipment and
accessories carefully. Check all materials against the packing list and check for any
mechanical damage. Contact us in case of any problem.

WARNING
 When disposing of the packaging material, be sure to observe the applicable
waste control regulations and keep it out of children’s reach.
 The equipment might be contaminated during storage and transport. Before
use, please verify whether the packages are intact, especially the packages of
single use accessories. In case of any damage, do not apply it to patients.

NOTE
 Save the packing case and packaging material as they can be used if the
equipment must be reshipped.

3.1.2 Environmental Requirements

The equipment is suitable for use within the patient environment.

The operating environment of the equipment must meet the requirements specified in
this manual.

The environment where the equipment is used shall be reasonably free from noises,
vibration, dust, corrosive, flammable and explosive substances. If the equipment is
installed in a cabinet, sufficient space in front and behind shall be left for convenient
operation, maintenance and repair. Moreover, to maintain good ventilation, the
equipment shall be at least 2 inches (5 cm) away from around the cabinet.

When the equipment is moved from one place to another, condensation may occur as a
result of temperature or humidity difference. In this case, never start the system before
the condensation disappears.

WARNING
 Make sure that the operating environment of the equipment meets the specific
requirements. Otherwise unexpected consequences, e.g. damage to the
equipment, could result.

3-2
 NOTE
 The equipment uses a mains plug as a means of isolation to the mains power
supply. Do not position the equipment in a place difficult to access the mains
plug.

3.2 General Operation

Read this operator's manual carefully before the use of this monitor. Familiarize yourself
with the equipment's function and operation, and observe the warnings and cautions
included in the manual.

3.2.1 Connection to AC Power

This monitor can be powered by AC power or battery. Connect the power cord to the AC
input on the back of the monitor, and connect the other end of the power cord to the
power outlet.

WARNING
 Always use the accompanying power cord with the monitor.
 Where the integrity of the external protective conductor in the installation or
its arrangement is in doubt, the equipment shall be operated from the battery.

3.2.2 Using a Battery

This monitor can be equipped with rechargeable Lithium-ion battery. If a battery is
installed, the monitor system will automatically switch to battery for power supply if AC
power is interrupted.

Installing a Battery
Battery compartment cover is at the bottom of monitor. Refer to 15.3 Replacing a Battery
for additional information of battery installation.

NOTE

 When a battery has been stored for a long time, or the battery is depleted,
recharge the battery at once. Otherwise, the low battery may not support to
power up the monitor if the AC power is unavailable.

Charging a Battery
The battery is charged whenever the monitor is connected to an AC power source
regardless of whether the monitor is currently on or not.

When the battery is charging, the battery indicator is On. The battery charge icon on the

3-3
 screen dynamically displays the charging status when the monitor is powered on.

3.2.3 Connecting Accessories

Insert the hose of NIBP cuff into the cuff connector on the side of monitor; insert the SpO2
cable into the SpO2 cable connector on the side of monitor; insert the temperature probe
cable into the TEMP probe connector on the back of monitor.

3.3 Turning On/Off Power

3.3.1 Check before Power On
It is recommended to check the followings before power on the monitor:
 Environment
If other electric devices, such as electrosurgical unit, ultrasound, X-ray machine, are
around the monitor, power off those devices if the measurement is interfered.
 Power Supply
Check that power supply specification is met and the power cord is securely
connected if mains power is used. Use only power socket that is properly grounded.
Check that a battery is installed and fully charged if battery is used.
 Connecting Accessories
Verify that the connection of all accessories to monitor is secured.

3.3.2 Turning Power On

Once the monitor is installed, you can get ready for measurement.
1. Check the monitor for any mechanic damage, and make sure that all external cables,
plug-ins and accessories are properly connected.
2. Check the power supply specification is met if mains power is used. Only use a power
outlet that is properly grounded.
3. Plug the power cord into the AC power source. If you run the monitor on battery
power, ensure that the battery is sufficiently charged.
4. Press the power on/off switch on the monitor’s front.

The monitor will perform alarm system self-test during startup. After pressing the power
on/off button, the system sounds a beep, and the alarm lamp simultaneously turns yellow,
then red, and then turns off, with the start-up screen being shown. Then the start-up
screen disappears. The alarm system self-test succeeds. The monitor enters the normal
monitoring screen.

For further testing of individual measurement alarms, perform the measurement on

yourself (for example SpO2 or CO2) or use a simulator. Adjust alarm limits and check that
appropriate alarm behavior is observed.

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 WARNING
 Do not use the monitor on a patient if you suspect it is not working properly, or
if it is mechanically damaged. Contact your service personnel or us.
 Check that visual and auditory alarm signals are presented correctly when the
equipment is powered on. Do not use the equipment for any monitoring
procedure on a patient if you suspect it is not working properly, or if it is
mechanically damaged. Contact your service personnel or Mindray.

NOTE

 Carefully check if the system performs the self-test as described above. Contact
your service personnel or us if the self-test is abnormal.

3.3.3 Turning off the Monitor

Before turning off the monitor:
1. Confirm that the monitoring is finished.
2. Disconnect patient cables and sensors from the patient.
3. Make sure to save or clear the patient monitoring data as required.

Press and hold the power on/off switch for above 2 seconds to turn off monitor.

CAUTION
 Although not recommended, you can press and hold the power on/off switch
for 10 seconds to forcibly shut down the monitor when it could not be shut
down normally or under some special situations. This may cause data loss of the
monitor.
 The monitor restores the latest configuration if restarts within 60 seconds after
the power failure. And it will restore the default configuration rather than the
latest configuration if restarts 120 seconds later after the power failure. The
monitor may load either the latest configuration or the default configuration if
restarts from 60-120 seconds after the power failure.
 Power failure may cause data damage on SD card. It is recommended to turn off
the monitor according to the normal procedures. Do not directly unplug the
power cord, unless there is a charged battery installed, or remove the battery
before shutting down the monitor.

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3.4 Using Key, Knob, Touchscreen
3.4.1 Using Keys
The monitor has three types of keys:
 Softkey: A softkey is a graphic key on the screen, giving you fast access to
certain menus or functions. The monitor has two types of softkeys:
 Parameter keys: Each parameter area or waveform area can be seen as a softkey.
You can enter a parameter setup menu by selecting its corresponding
parameter area or waveform area.
 QuickKeys: QuickKeys are configurable graphical keys, located at the bottom of
the main screen.
 Hardkeys: A hardkey is a physical key on a monitoring device, such as the Alarm
Reset hardkey and admit patient hardkey on the front panel.
 Pop-Up Keys: Pop-up keys are task-related menu keys that appear automatically
on the monitor screen when required. For example, the confirm pop-up key
appears only when you need to confirm a change.

3.4.2 Using the Knob

Using the knob on the front panel of the monitor can do the following operations:
 Rotate the knob clockwise or anti-clockwise to move the cursor.
 Press the knob to select one item, such as accessing a menu or confirming the
selection

3.4.3 Using the Touchscreen

Select screen items by pressing them directly on the monitor’s screen. You can enable or
disable touchscreen operation by pressing and holding the [Main] QuickKey for 3 seconds.

A padlock symbol on the [Main] QuickKey is displayed if touchscreen operation is

disabled.

When the touchscreen is locked, powering off the monitor and restarting it will
automatically unlock the touchscreen.

3.5 Changing General Settings

This section covers only general settings such as language, brightness, date and time, etc.
Measurement settings and other settings can be referred to the respective sections.

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3.5.1 Setting up a Monitor
To install a monitor or change the monitor’s location, you need to set it as follows:
1. Select [Main]→ [Maintenance >>]→[User Settings >>]→ Enter the required
password→ Select [Ok] and then access [User Settings] menu.
2. Set up [Monitor Name], [Department] and [Bed No.].
You can set [Changing Bed No.] to:
 [Unprotected]: enables you to change Bed No. from the [Patient Demographics]
menu.
 [Protected]: prevents you from changing Bed No. from the [Patient
Demographics] menu.

3.5.2 Changing Language

1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter the required
password Select [Ok] to access [User Settings] menu.
2. Select [Language] and then select the desired language.
3. Restart the monitor.

3.5.3 Configuring the Timeout of Clinician ID

You can configure the retention time of a clinician ID each time it is entered.
1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter the required
password→Select [Ok]and then access [User Settings] menu.
2. Select [Clinician ID Time out] and then set the time.

3.5.4 Showing/Hiding Patient Name

You can show or hide the current patient name in the main screen. To do so, follow this
procedure:
1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter the required
password→Select [Ok] and then access [User Settings] menu.
2. Select [Patient Demographics].
3. Set [Display Patient Name] to [Yes] or [No].
 [Yes]: the patient’s name display in the main screen.
 [No]: the patient’s name does not display in the main screen.

3.5.5 Adjusting Alarm Volume

1. Select [Main]→[General Setup>>].

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 2. Select [Alarm Volume] and then select the appropriate volume: X-10, in which X is
the minimum volume, depending on the set minimum alarm volume (refer to 6.5.2
Setting the Minimum Alarm Volume), and 10 the maximum volume.

The alarm tone is switched off when the volume is set to [0].

3.5.6 Adjusting Key Volume

The monitor can provide a tone according to the settings in key volume when you press
the knob or hard key, or touch the screen.
1. Select [Main]→[General Setup>>].
2. Select [Key Volume] and then select the appropriate volume: 0-10, in which 0 means
off, and 10 the maximum volume.

3.5.7 Adjusting the Screen Brightness

If the monitor operates on a battery power, you can set a less bright screen to prolong the
operating time of the battery. When the monitor enters Standby mode, the screen will
change to the least brightness automatically.
1. Select [Main]→[General Setup>>].
2. Select [Brightness] and select the appropriate setting for the screen brightness. 10 is
the brightest, and 1 is the least bright.

3.5.8 Setting Screen

1. Select [Main]→[General Setup>>].
2. Select [Display Setup] and set the main screen to different layout: All Parameters
display, Trend display or NIBP List display.
 All Parameters display includes parameter area, waveform area, but no trend.
 Trend display includes parameter area, tabular trends, but no waveform area.
 NIBP List display includes parameter area, NIBP list, but no waveform area.

3.5.9 Configuring the Timeout of Measured Value

1. Select [Main]→[General Setup>>].
2. Select [Parameter Time Out] to set the retention time for the digital value of current
NIBP and temperature measurement displayed on the screen.

The options are 5 min, 10 min, 15 min, and 30 min and off. When [Off] is selected, the
digital value of current NIBP and temperature measurement will always display on the
screen until the new measured value replace it.

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3.5.10 Configuring Measurement Colors
You can set the desired color for the parameters.
Select [Main]→[General Setup>>]→ [Parameter Color Setup>>] and then the [Color
Setup] menu pops up.

3.5.11 Setting the Date and Time

1. Select [Main]→[General Setup>>]→[System Time>>].
2. Set [Date] and [Time].
3. Select [Date Format] and toggle between [yyyy-mm-dd], [mm-dd-yyyy] and
[dd-mm-yyyy].
4. Select [Time Format] and toggle between [24h] and [12h].

CAUTION
 Changing date and time affects the storage of trends and events and may cause
data missing.

3.5.12 Configuring Unit

To enter the [Unit Setup] menu, select [Main]→[General Setup>>]→[Unit Setup>>].

3.5.13 Configuring Printout

You can select the items to be printed on the strip. By default, all items are selected.

To enter the [Print Setup] menu, select [Main]→[General Setup>>]→[Print Setup>>]

and then pops up.

3-9
FOR YOUR NOTES

3-10
4 Patient Data Management

4.1 Admitting a Patient

The monitor displays physiological data and stores them in the trends as soon as a patient
is connected. This allows you to monitor a patient that is not admitted yet. However, it is
recommended that you fully admit a patient so that you can clearly identify your patient,
on recordings, reports and networking devices.

NOTE

 If the monitor enters and then exits Standby mode during patient monitoring,
you must re-admit the patient for the monitoring.

4.1.1 Admitting a Patient by the Admit Patient Hardkey

1. Press the Admit Patient hardkey to access [Patient Demographics] menu.

2. Enter the demographic details.

If the monitor is connected to ADT database through Gateway, when you input
patient MRN, the patient information in the same MRN stored in ADT database will
automatically synchronize to patient demographics of the monitor.
3. Select [Ok] key.

4-1
 You can self-define the [Patient Demographics] menu.
1. Select [Main]→[Maintenance >>]→[User Settings >>]→enter the required
password→select [Ok] to access [User Settings] menu.
2. Select [Patient Demographics>>].
3. Select the desired items in [Patient Demographics Setup] menu.
 [Required Information]: the items that must be entered or selected when you
send the data to the eGateway.
 [Optional Information]: the optional information in admitting a patient. You
can also customize four options as optional information.
4. Select to save the configuration and exit the menu.

NOTE
 In [User Settings]→[Patient Demographics>>]→[Patient Demographics Setup]
menu, the mark '*' is before the required input item. Only all the items are
entered, the patient's demographics can be sent to the eGateway.
 If a clinician ID is entered, but no operation on the monitor for a certain time,
the monitor will clear up the ID. Refer to 3.5.3 Configuring the Timeout of
Clinician ID.

4.1.2 Admitting a Patient by Barcode Scanner

The monitor provides the ability to admit a patient through linear or two-dimension
barcode scanner.

NOTE
 If the patient demographics is obtained from barcode scanner, the patient
demographics cannot be changed.

4.1.2.1 With Linear (1D) Barcode Scanner

To admit a patient with a 1D barcode scanner, follow this procedure:
1. Connect the barcode scanner to the USB connector on the monitor.
2. Aim the barcode scanner to the barcode.
3. Select [Ok] key on the [Patient Demographics] menu to admit the patient.

4.1.2.2 With Two-Dimension (2D) Barcode Scanner

Configuring the Scanner

When the scanner is first used in your hospital, you need to clear and re-establish the data
format for the scanner before admit a patient.

4-2
 1. Connect the barcode scanner to the USB connector on the monitor.
2. Aim the scanner at the following barcode to clear the previous data format.

3. Aim the scanner at the 2D image which contains your hospital’s barcode data format.
Contact the scanner manufacturer for obtaining this image.

Setting the Monitor

After you have set up the data format for the 2D scanner, follow this procedure to set up
the monitor:
1. Select [Main]→[Maintenance >>]→[User Settings >>]→enter the required
password→select [Ok] to access [User Settings] menu.
2. Select [Scanner Setup>>]→[2D Barcode Setup>>]. The setup screen displays.
3. Establish the relationship between the monitor data and barcode data for selectable
patient demographics. For example, the monitor has an option of [Adult] for patient
category. In your hospital barcode, the text may read as [Adu]. You need to input
[Adu] for the field [Adult] to establish the relationship. The following aspects need to
establish the relationship:
 Patient Category
 Gender
 Month
4. Select to save the configuration and exit the [2D Barcode Setup] menu.
5. Select the desired pop-up menu if you scan the patient barcode.
 [Patient Demographics]: the [Patient Demographics] menu displays.
 [ADT Database]: the [ADT Database] tab displays.

NOTE
 If there is existing open menu or window, the [Patient Demographics] menu or
[ADT Database] tab will not pop up.

5. Select to save the configuration and exit the menu.

Admitting a Patient
To admit a patient, follow this procedure:
1. Connect the barcode scanner to the USB connector on the monitor.

4-3
 2. Aim the scanner at the clinician barcode and press the scan button at the barcode
scanner. The clinician ID will populate the [Clinician ID] field in the [Patient
Demographics] menu.
3. Aim the scanner at the patient barcode and press the scan button on the barcode
scanner. The pop-up menu that opens depends on if [Patient Demographics] or
[ADT Database] is selected at the [Scanner Setup>>] menu.
4. Select [Ok] to admit the patient.

4.1.3 Admitting a Patient from [Patient List]

Admit a Patient from [Local Patient List].
1. Press [Patient List] QuickKey, and then [Local Patient List] screen displays.
2. Select the page key (for example ), and then use up or down arrow
beside the key to turn to another page, or select [Scroll] key and then use up or
down arrow beside the key to select the desired patient.
3. Select [Admit] to access [Patient Demographics] menu.
4. Select [Ok]. If necessary, you can modify patient information and then select [Ok].

In [Local Patient List], you also can:

 Select [Add New], and then [Patient Demographics] menu displays. Input
patient information and then select [Ok] to admit the patient.
 Select [Delete] to remove currently selected patient from the monitor.
 Select [Delete All] to remove all the patients from the monitor.

NOTE
 When a patient’s demographics is deleted, all his patient data in the monitor
will be deleted at the same time.
 You cannot delete the currently monitoring patient.

Admitting a Patient from [ADT Database]

When the monitor is connected to ADT database through Gateway, the monitor can
obtain patient information from ADT database.
1. Access the [ADT Database] screen by either way.
 Select [Patient List] QuickKey→[ADT Database] tab.
 Aim the 2D barcode scanner at the patient barcode. Refer to 4.1.2.2 With
Two-Dimension (2D) Barcode Scanner for scanner and monitor configuration.
2. Select [ADT Database], and then ADT database screen displays.
3. Search a patient.

4-4
  Input [Department] name, and then the system will search the patient within
the department.
 Input [MRN], and then the system will search the patient according to the input
medical record number.
 Input [Last Name] and/or [First Name], and the system will search patient upon
the name.
4. Select the page key (for example, ), and then use up or down arrow
beside the key to turn to another page, or select [Scroll] key and then use up or
down arrow beside the key to select the desired patient.
5. Select [Admit] to access [Patient Demographics] menu.
6. Select [Ok]. If necessary, you can modify patient information and then select [Ok].

4.2 Manually Input Patient Data

You can choose whether to display the manual input area on the screen and configure the
items to be displayed in the manual input area:
1. Select [Main]→[Maintenance >>]→[User Settings >>]→enter the required
password→Select [Ok] to access [User Settings] menu.
2. Select [Manual Inputs>>].
3. In the [Manual Inputs Setup] menu, you can
 Configure the items to be displayed in the manual input area.
 Select [Manual Input Area] and toggle between [On] and [Off] to display or
hide the manual input area.

4. Select to save the configuration and exit the menu.

The following picture shows the manual input area which is located at the bottom of the
screen if displayed.

4-5
 After the manual input area is selected, the [Manual Inputs] menu pops up. The
displayed items correspond to the settings in [Manual Inputs Setup].

4.3 Manually Save Patient Data

Select [Save] QuickKey to save the demographics, scoring data, measurements and
manual input of the current patient.

You can configure the data processing mode for the manually saved data.
1. Select [Main]→[Maintenance >>]→[User Settings >>]→enter the required
password→select [Ok] to access [User Settings] menu.
2. Select [‘‘Save’’ Button Options>>].
3. In [‘‘Save’’ Button Setup] menu, select the followings:
 [Automatically Send On Manual Save]: the data will be saved locally and
meanwhile sent to the external devices when the [Save] QuickKey is selected
and confirmed, and/or
 [Automatically Record On Manual Save]: the data will be saved locally and
meanwhile printed by recorder when the [Save] QuickKey is selected and
confirmed.
 [Clear Clinician ID at Saving]: the data saves locally and the monitor clears the
clinician ID when the [Save] Quickkey is selected.
 [Open ‘Results’ Menu at Saving]: the data saves locally and the [Results] menu
displays when the [Save] QuickKey is selected. You can edit patient
demographics and manual input data at [Results] menu.
 [Discharge Patient at Spot Check Saving]: the data saves locally and the
monitor discharges the current patient when the [Save] QuickKey is selected.
4. Select to save the configuration and exit the menu.

4-6
4.4 Reviewing Patient Data
Select [Review] QuickKey, and you can review the trends.

In Monitor mode, you can view:

 Spot check trends
 Continuous trends
 Graphic trends

In Spot Check mode, you can view only spot check trends.

4.4.1 Spot Check Trends

Select the [Spot Check Trends] tab to access the Spot Check Trends screen.

(4)

(3)

(1)

(2)

(1) Tabular trend (2) Button area

(3) Data status (4) Parameter value triggering alarm

In this tab, you can:

 Select [MRN] or [Name] and then select the desired patient.
 Select [Filter] to select parameter trends you want to review.
 Select the page key (for example ) and then use up or down arrow
beside the key to turn the page.
 Select [Edit] to edit patient demographics or manual input data of selected
patient.
 Select [Delete] to delete the trend data of selected patient.

4-7
  Select [Print] to print the trend data of selected patient.
 Select [Send] to transmit the selected patient’s trend data to the EMR through
an eGateway.

NOTE
 The trend data can only be sent out when the monitor is connected to Electronic
Medical Record system (EMR).

In the spot check tabular trends:

 Parameter value triggering high level alarm has a red background; parameter
value triggering medium or low level alarm has a yellow background.

 The required patient demographics that is not fully filled displays as

 Patient data successfully sent to the EMR displays as

 Patient data that failed to transmit to the EMR displays as

 Patient data that is cached on the device but not transmitted displays as

4.4.2 Continuous Trends

Select [Continuous Trends] tab to access the Continuous Trends screen.

(3)

(1)

(2)

(1) Tabular trend (2) Button area (3) Parameter value triggering alarm

In this tab, you can:

4-8
  Select [MRN] or [Name] to select the desired patient.
 Select [Interval] to set the interval for the data to be displayed.
 Select the page key (for example ), and then use up or down arrow
beside the key to turn the page.
 Select [Print] to print the trend data of selected patient.
 Select [Delete All] to delete the trend data of selected patient.

Parameter value triggering high level alarm has a red background; parameter value
triggering medium or low level alarm has a yellow background.

4.4.3 Graphic Trends

Select [Graphic Trends] tab to access the Graphic Trends screen. The Graphic Trend
screen displays the current patient's physiological trend.

(1)
(2)

(3) (4)

(5)
(6)

(1) Event mark area (2) Time scale (3) Graphic area
(4) Parameter area (5) Cursor (6) Button area

A timestamp indicating your current position is displayed above the parameter area. The
parameter value corresponding to the cursor time appears in the parameter area. The
measurement value that triggered a high level alarm has red background. The
measurement that triggered the medium/low level alarm has a yellow background.

Events are marked with colors in the event mark area. Red represents a high level alarm
event. Yellow represents a medium/low level alarm event.

In the Graphic Trends screen, you can:

4-9
  Select [Zoom] to set the time length of the trend displayed on the screen.

 Select [Scroll] and control or key to move the cursor. Select or

to move the cursor to the previous or next page.

 Select [Event] and control or key to quickly locate the event.

 Select [Print] to print the selected patient’s graphic trend data currently on the
screen.

NOTE
 Pausing or switching off alarms will not be recorded as events. The time of these
operations will not be recorded in the system log.
 A total loss of power has no impact on the saved events.
 Events recorded earlier might be overwritten by later ones if the storage
memory reaches capacity.

4.5 Transferring Data from the Monitor to USB Drive

1. Insert a USB drive to the USB connector on the monitor.
2. Select [Main]→[Maintenance >>]→[User Settings >>]→enter the required
password→select [Ok] to access [User Settings] menu.
3. Select [Transfer Data to USB].
4. Select [Period] and select your desired time.
5. Select [Transfer Data].

CAUTION
 The USB drive you use may have write-protect function. In this case, please
make sure the USB drive for data transfer is in read/write mode.
 Do not remove the storage medium during data transfer process. Otherwise,
data files may be damaged.
 The normal monitoring function will be affected during data export. Do not
perform any monitoring activity during data export.

4-10
5 Managing Configurations

5.1 Overview
When performing continuous monitoring on a patient, the clinical professional often
needs to adjust the monitor’s settings according to the patient’s condition. The collection
of all these settings is called a configuration. Allowing you to configure the monitor more
efficiently, the monitor offers different sets of configuration to suit different patient
categories and departments. You can change some settings from a certain set of
configuration and then save the changed configuration as a user configuration.

WARNING
 The configuration management function is password protected. The
configuration management tasks must be performed by clinical professionals.

The system configuration items can be classified as:

 Parameter configuration items
These items relates to parameters, e.g. alarm switch, alarm limits.
 Conventional configuration items
These items define how the monitor works, e.g., display setup, print and alarm
settings.
 User maintenance items
These items relates to user maintenance settings, e.g., unit setup, time format.

For the important configuration items and their default values and user maintenance
items, see Appendix C Default Configurations.

5.2 Accessing [Manage Configuration] Menu

1. Select [Main]→[Maintenance >>]→[User Settings >>]. Enter the required password
and then select [Ok].
2. Select [Manage Configuration >>].

5-1
5.2.1 Setting Default Configuration
The monitor will load the pre-set default configuration in the following cases.
 The monitor is restarted after being switched off for above 120 seconds.
 A patient is admitted.
 A patient is discharged.
 Patient category is changed.

The default configuration may come from the latest configuration, the factory default
configuration or the user configuration.

To set the default configuration:

1. Select [Select Default Config >>] in the [Manage Configuration] menu.
2. Select [Load Latest Config] or [Load Specified Config] in [Select Default Config]
menu.

When you select [Load Specified Config.], the configuration (adult, pediatric or neonate)
to be restored is subject to the patient category. This configuration can be either factory
configuration or saved user configuration. Take adult as an example, select [Default Adult
Config] and toggle between [Defaults] and user configuration(s).

NOTE
 When the equipment starts, it shows what configuration is restored at the
prompt information area for about 30 seconds.

5.3 Saving Current Settings

Current settings can be saved as user configuration. Up to 3 user configurations can be
saved.

To save current settings:

1. Select [Save Current Settings As >>] in the [Manage Configuration] menu.
2. In the popup dialog box, enter the configuration name and then select [Ok].

5.4 Deleting a Configuration

1. Select [Delete Config >>] in the [Manage Configuration] menu. The popup menu
shows the existing user configurations on the monitor. Selecting [Config on USB
drive >>] will show the existing user configurations on the USB drive.
2. Select the user configurations you want to delete and then select [Delete].
3. Select [Yes] in the popup.

5-2
5.5 Transferring a Configuration
When installing several monitors with identical user configuration it is not necessary to
set each unit separately. A USB drive may be used to transfer the configuration from
monitor to monitor.

To export the current monitor’s configuration:

1. Insert a USB disk to the monitor’s external device connector.
2. Select [Export Config >>] in the [Manage Configuration] menu.
3. In the [Export Config] menu, select the configurations and the user maintenance
settings to be exported. Then select the [Export] button.

To import the configuration on the USB drive to the monitor:

1. Connect the USB Drive to the monitor’s external device connector.
2. Select [Import Config >>] in the [Manage Configuration] menu.
3. In the [Import Config] menu, select the configurations and the user maintenance
settings to be imported. Then select the [Import] button. A status message will
report completion of the transfer.

5.6 Loading a Configuration

You may make changes to some settings during operation. However, these changes or the
pre-selected configuration may not be appropriate for the newly admitted patient.
Therefore, the monitor allows you to load a desired configuration so as to ensure that all
the settings are appropriate for your patient.

To load a configuration:
1. Select [Load Configuration >>] from the main menu. The popup menu shows the
existing configurations on the monitor. Selecting [Config on USB drive >>] will
show the existing configurations on the USB drive.
2. Select a desired configuration.
3. Select [Load] to load this configuration.

The current configuration is shown at the top of the [Load Configuration] menu.

5-3
5.7 Restoring the Latest Configuration Automatically
During operation, you may make changes to some settings. However, these changes may
not be saved as user configuration. To prevent the changes from losing in case of a
sudden power failure, the equipment stores the configuration in real time. The saved
configuration is the latest configuration.

The monitor restore the latest configuration if restarts within 60 seconds after the power
failure. And it will restore the default configuration rather than the latest configuration if
restarts 120 seconds later after the power failure. The monitor may load either the latest
configuration or the default configuration if restarts from 60-120 seconds after the power
failure.

5-4
6 Alarms

Alarms, triggered by a vital sign that appears abnormal or by technical problems of the
monitor, are indicated to the user by visual and audible alarm indications.

WARNING
 A potential hazard can exist if different alarm presets are used for the same or
similar equipment in any single area, e.g. an intensive care unit or cardiac
operating room.
 If your equipment is connected to a CMS, remote suspension, inhibition, silence
and reset of monitor alarms via the CMS may cause a potential hazard. For
details, refer to the CMS’s instructions for use.

6.1 Alarm Categories

By nature, the equipment’s alarms can be classified into two categories: physiological
alarms and technical alarms.
1. Physiological alarms
Physiological alarms, also called patient status alarms, are triggered by a monitored
parameter value that violates set alarm limits or an abnormal patient condition. The
physiological alarms occur only in Monitor mode.

2. Technical alarms
Technical alarms, also called system status alarms, are triggered by a device
malfunction or a patient data distortion due to improper operation or mechanical
problems.

Apart from the physiological and technical alarm messages, the monitor shows some
messages telling the system status or patient status. System related messages are
displayed in system message area; parameter related messages are displayed in
respective parameter message area.

6-1
6.2 Alarm Levels
By severity, the equipment’s alarms can be classified into three categories: high level,
medium level and low level.

Physiological Alarms Technical Alarms

High level Indicate that your patient is Indicate a severe device malfunction or an
in a life threatening situation improper operation, which could make it
and an emergency possible that the monitor cannot detect
treatment is demanded. critical patient status and thus threaten the
patient’s life.
Medium Indicate that your patient’s Indicate a device malfunction or an
level vital signs appear abnormal improper operation, which may not
and an immediate treatment threaten the patient’s life but may
is required. compromise the monitoring of vital
physiological parameters.
Low level Indicate that you patient’s Indicate a device malfunction or an
vital signs appear abnormal improper operation, which may
and an immediate treatment compromise a certain monitoring function
may be required. but will not threaten the patient’s life.

6.3 Alarm Indicators

When an alarm occurs, the equipment will indicate it to the user through visual or audible
alarm indications.
 Alarm lamp
 Audible alarm tones
 Alarm message
 Flashing numeric

6.3.1 Alarm Lamp

If a technical alarm or physiological alarm occurs, the alarm lamp will flash. The color and
flashing frequency match the alarm level as follows:
 High level alarms: the lamp quickly flashes red.
 Medium level alarms: the lamp slowly flashes yellow.
 Low level alarms the lamp lights yellow without flashing.

NOTE
 When multiple alarms of different levels occur simultaneously, the monitor will
select the alarm of the highest level and give visual alarm indications
accordingly.

6-2
6.3.2 Audible Alarm Tones
The monitor uses different alarm tone patterns to match the alarm priority.

The alarm tone is distinct from keystroke tone and pulse tone in frequency.

The alarm tones identify the alarm levels as follows:

 High level alarms: triple+double beeps+triple+double beep.
 Medium level alarms: triple beep.
 Low level alarms: single beep.

The interval of alarm tone is configurable. Refer to 6.5.3 Setting the Interval between
Alarm Sounds.

NOTE
 When multiple alarms of different levels occur simultaneously, the monitor will
select the alarm of the highest level, give alarm sounds accordingly. Multiple
alarm messages scroll on the screen.

6.3.3 Alarm Messages

When an alarm occurs, an alarm message will appear in the technical or physiological
alarm area.

The alarm message has different background color which matches the alarm level.
 High level alarms: red
 Medium level alarms: yellow
 Low level alarms: yellow

For physiological alarms, the asterisk symbols (*) before the alarm message match the
alarm level as follows:
 High level alarms: ***
 Medium level alarms: **
 Low level alarms: *

When there are multiple messages, the messages will be displayed circularly.

NOTE
 Some physiological alarms, such as the Desat alarm, are exclusive. They have
identical alarm tones and alarm lights as normal high level physiological
alarms, but their alarm messages are displayed exclusively. When an exclusive
physiological alarm and a normal high level physiological alarm are triggered
simultaneously, only the exclusive physiological alarm message is displayed.

6-3
6.3.4 Flashing Numerics
If an alarm triggered by an alarm limit violation occurs, the numeric of the measurement
in alarm will flash every second, and the corresponding alarm limit will also flash at the
same frequency indicating the high or low alarm limit is violated.

6.3.5 Alarm Status Symbols

Apart from the aforementioned alarm indicators, the equipment still uses the following
symbols telling the alarm status:

 indicates alarms are paused.

 indicates alarms are reset.

 indicates the alarm sound is turned off.

6.4 Setting Alarms

You can set the switch, limit and level of physiological alarms.
Select [Main]→[Alarm Setup >>], and then access the [Alarm Setup] screen.

 [Auto Set]: The monitor will create new alarm limits based on the measured
values.
 [Restore Defaults]: The restored defaults depend on the settings in [Select
Default Config] screen. If the latest configuration is set as the default
configuration, then the factory configuration will be loaded for the alarm
settings; if specified configuration is set as the default configuration, then the
specified configuration will be loaded for the alarm settings. Refer to 5.2.1
Setting Default Configuration.

6-4
 WARNING
 Make sure that the alarm limits settings are appropriate for your patient before
monitoring.
 Setting alarm limits to extreme values may cause the alarm system to become
ineffective. For example, High oxygen levels may predispose a premature infant
to retrolental fibroplasia. If this is a consideration do NOT set the high alarm
limit to 100%, which is equivalent to switching the alarm off.

6.5 Selecting Alarm Properties

6.5.1 Changing the Alarm Volume
Select [Main]→[General Setup >>]→[Alarm Volume].

The alarm volume range is between X to 10. X is the minimum volume, which depends on
the setting of minimum alarm volume (Refer to 6.5.2 Setting the Minimum Alarm
Volume), and 10 is the maximum volume.

When alarm volume is set to 0, the alarm sound is turned off and a symbol appears
on the screen.

6.5.2 Setting the Minimum Alarm Volume

1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter the required
password→Select [Ok] to access [User Settings] menu.
2. Select [Alarm Setup >>] to access [Alarm Setup] menu.
3. Select [Minimum Alarm Volume] and then select the appropriate settings.

The minimum alarm volume refers to the minimum value you can set for the alarm
volume, which is not affected by user or factory default configurations.

6.5.3 Setting the Interval between Alarm Sounds

1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter the required
password→Select [Ok] to access [User Settings] menu.
2. Select [Alarm Setup >>] to access [Alarm Setup] menu.
3. Select [High Alarm Interval (s)], [Med Alarm Interval (s)] and [Low Alarm Interval
(s)] in turn and then select the appropriate settings.

6-5
 WARNING
 When the alarm sound is switched off, the equipment will give no audible alarm
tones even if a new alarm occurs. Therefore the user should be very careful
about whether to switch off the alarm sound or not.
 Do not rely exclusively on the audible alarm system for patient monitoring.
Adjustment of alarm volume to a low level may result in a hazard to the patient.
Always keep the patient under close surveillance.

6.5.4 Adjusting Alarm Limits Automatically

The monitor can automatically adjust alarm limits according to the measured vital signs,
using the auto limits function. When auto limits are selected, the monitor calculates safe
auto limits based on the latest measured values.

To get accurate auto alarm limits, you need to collect a set of measured vital signs as a
baseline. Then, in the main menu, select [Main]→[Alarm Setup>>]→[Auto Set] →Select
[Ok] in the pop-up window. The monitor will create new alarm limits based on the
measured values.

Before applying these automatically created alarm limits, confirm if they are appropriate
for your patient. If not, you can adjust them manually.

The monitor calculates the auto limits based on the following rules.
Parameter Low alarm Limit High alarm Limit Auto-set alarm
limit
Adult/ Neonate Adult/ Neonate
Pediatric Range
Pediatric
SpO2 Same as the Same as the Same as the Same as the Same as the
default alarm default alarm default alarm default alarm measurement
limit limit limit limit range

PR (PR×0.8) or 40 (PR-30) or 90 (PR×1.25) or (PR+40) or 200 Adult/Pediatric:

bpm, whichever bpm, 240 bpm, bpm, 35 to 240 bpm
is greater whichever is whichever is whichever is
Neonate:
greater smaller smaller
55 to 225 bpm
NIBP-S (SYS×0.68)＋ (SYS-15) or (SYS×0.86)＋ (SYS＋15) or Adult:
10mmHg 45mmHg, 38mmHg 105mmHg， 45 to 270 mmHg
whichever is whichever is Pediatric:
greater smaller
45 to 185 mmHg
Neonate:
35 to 115 mmHg

6-6
Parameter Low alarm Limit High alarm Limit Auto-set alarm
limit
Adult/ Neonate Adult/ Neonate
Pediatric Range
Pediatric
NIBP-D (Dia×0.68)＋ (Dia-15) or (Dia×0.86)＋ (Dia＋15) or Adult:
6mmHg 20mmHg， 32mmHg 80mmHg， 25 to 225 mmHg
whichever is whichever is Pediatric:
greater smaller
25 to 150 mmHg
Neonate:
20 to 90 mmHg
NIBP-M (Mean×0.68)＋ (Mean-15) or (Mean×0.86) (Mean＋15) or Adult:
8mmHg 35mmHg， ＋35mmHg 95mmHg， 30 to 245 mmHg
whichever is whichever is Pediatric:
greater smaller
30 to 180 mmHg
Neonate:
25 to 105 mmHg
Temp (T－0.5)°C (T－0.5) °C (T＋0.5) °C (T＋0.5)°C Same as the
measurement
range
EtCO2 0 to 32: remains 0 to 32: 0 to 32: 0 to 32: Same as the
the same remains the remains the remains the measurement
same same same range
33 to 35: 29 33 to 35: 29 33 to 35: 41 33 to 35: 41 Same as the
measurement
range
36 to 45: (EtCO2 36 to 45: 36 to 45: 36 to 45: (EtCO2 Same as the
- 6) (EtCO2 - 6) (EtCO2 + 6) + 6) measurement
range
46 to 48: 39 46 to 48: 39 46 to 48: 51 46 to 48: 51 Same as the
measurement
range
>48: remains >48: remains >48: remains >48: remains Same as the
the same the same the same the same measurement
range
FiCO2 None None Same as the Same as the Same as the
default alarm default alarm measurement
limit limit range

6-7
6.6 Pausing Alarms
You can temporarily disable alarm indicators by pressing and holding hardkey on
the panel for above 2 seconds.

When alarms are paused,

 The alarms pause symbol and the remaining alarm pause time is displayed
in Alarm Information area.
 For physiological alarms, no alarm indication is shown. New physiological alarm
will not be presented.
 For technical alarms, alarm sounds are paused, but alarm lamps and alarm
messages remain presented.

The default alarm pause time is 2 minutes. When the alarm pause time expires, or the low
battery alarm occurs, the alarm paused status is automatically deactivated. You can also
cancel the alarm paused status by pressing and holding the hardkey for more than
2 seconds.

6.7 Switching Off Alarm Sound

When alarm volume is set to 0, the alarm sound is turned off. In audio alarm off status,

 The Audio Off symbol is displayed.

 Audio indication of all alarms is suspended.

You can cancel the alarm sound off status by setting alarm volume to a value from 1 to 10.

WARNING
 Pausing or switching off alarms may result in a hazard to the patient. Please be
very careful.

6.8 Resetting Alarms

By pressing the hardkey, you can reset the alarm system to acknowledging the
on-going alarms and enable the alarm system to respond to a subsequent alarm
condition.

For physiological alarms, except the NIBP-related alarms, when the alarm system is reset:
 The alarm sound is silenced.
 A √ appears before the alarm message, indicating that the alarm is
acknowledged.

6-8
  The icon appears in the alarm symbol area.
 The parameter numeric and alarm limits still flash.

The indication of alarm lamp for the physiological alarm depends on the alarm light
setting.
 When [Alarm Light on Alarm Reset] is set to [On], the alarm lamp remains
flashing.
 When [Alarm Light on Alarm Reset] is set to [Off], the alarm lamp stops flashing.

To set [Alarm Light on Alarm Reset]:

1. Select [Main]→ [Maintenance >>]→ [User Settings >>]→ enter the required
password → Select [Ok] to access [User Settings] menu.
2. Select [Alarm Setup >>] to enter the [Alarm Setup] menu.
3. Select [Alarm Light on Alarm Reset], and toggle between [On] and [Off].
The default setting for [Alarm Light on Alarm Reset] is [On].

Technical alarms give different alarm indicators when the alarm system is reset:
 For some technical alarms, including the NIBP-related alarms, a √ appears
before the alarm message and appears in the alarm symbol area,
indicating that the alarm is acknowledged. The indication of the alarm lamp
depends on the alarm light setting.
 Some technical alarms are changed to the prompt messages.
 Some technical alarms are cleared. The monitor gives no alarm indications.

For details about the indications of technical alarms when the alarm system is reset, refer
to D.2 Technical Alarm Messages.

6.9 Setting the Reminder Tone

In audio off status, the monitor can issue a periodical reminder tone. The interval of the
reminder tone is 1 minute. You can switch on or off the reminder tone.
1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter required password→
Select [Ok] and then access [User Settings] menu.
2. Select [Alarm Setup >>] to access [Alarm Setup] menu.
3. Set [Reminder Tone] to [On] or [Off].

6-9
6.10 Latching Alarms
The latching setting for physiological alarms defines how alarm indicators behave when
you do not acknowledge them.
 If an alarm is latched, alarm indications remain presented even though alarm
conditions end, except that:
 The parameter reading and violated alarm limit stop flashing.
 The time when the alarm is last triggered is displayed behind the alarm
message.
 If an alarm is not latched, the alarm indications disappear as soon as the alarm
conditions end.

To latch a physiological alarm,

1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter required password→
Select [Ok] and then access [User Settings] menu.
2. Select [Alarm Setup >>].
3. Set [Alarm Latch] to [High only], [High&Med], [All] or [Off].
 [High only]: only high priority alarms are latched;
 [Hi&Med]: both high priority alarms and mediate priority alarms are latched;
 [All]: all alarms are latched; and
 [Off]: no alarm will be latched.

Only the unacknowledged physiological alarm can be latched. The latched alarms will be
cleared when the monitor enters alarm reset state.

NOTE
 Changing of alarm priority may affect the latching status of corresponding
alarm. Please determine if you need to reset the latching status for the specific
alarm when you have changed its alarm priority.

6.11 Actions for Alarm Occurrence

When an alarm occurs, observe the following steps and take proper actions:
1. Check the patient’s condition.
2. Confirm the alarming parameter or alarm category.
3. Identify the source of the alarm.
4. Take proper action to eliminate the alarm condition.
5. Make sure the alarm condition is corrected.

For details about how to deal with specific alarms, refer to Chapter D Alarm Messages.

6-10
6.12 Nurse Call
The monitor also provides a multi-function connector to output nurse call signals when a
user-defined alarm occurs. To obtain a nurse call signal, use the nurse call cable (P/N:
009-003116-00) we supply to connect the hospital nurse call system to the
multi-function connector of the monitor and then follow this procedure:
1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter required password→
Select [Ok] and then access [User Settings] menu.
2. Select [Nurse Call >>] to access the [Nurse Call >>] menu.
3. Select [Signal Type] and toggle between [Pulse] and [Continuous].
 [Pulse]: the nurse call signal is pulse signal and each pulse lasts 1 second. When
multiple alarms occur simultaneously, only one pulse signal is outputted. If an
alarm occurs but the previous one is not cleared yet, a new pulse signal will also
be outputted.
 [Continuous]: the nurse call signal lasts until the alarm ends, i.e. the duration
of a nurse call signal equals to that of the alarm condition.
4. Select [Contact Type] and toggle between [Normally Open] and [Normally
Closed].
 [Normally Open]: Select if your hospital’s nurse call relay contact is normally
open.
 [Normally Closed]: Select if your hospital’s nurse call relay contact is normally
closed.
5. Select [Alarm Level] and set the alarm level for nurse call-triggering alarms.
6. Select [Alarm Category] and then select the category to which the nurse
call-triggering alarms belong.

Alarm conditions are indicated to nurses only when:

1. The nurse call system is enabled
2. An alarm that meets your preset requirements occurs, and
3. The monitor is not in the alarm paused or silence status.

If no setting is selected from [Alarm Level] or [Alarm Category], no nurse call signal will
be triggered whatever alarms occur.

WARNING
 To obtain the nurse call signal, use the nurse call cable (PN: 009-003116-00) we
supply. Otherwise the nurse call function will not work and the monitor may be
damaged
 Do not rely exclusively on the nurse call system for alarm notification.
Remember that the most reliable alarm notification combines audible and
visual alarm indications with the patient’s clinical condition.

6-11
FOR YOUR NOTES

6-12
7 Monitoring SpO2

7.1 Overview
SpO2 monitoring is a non-invasive technique used to measure the amount of oxygenated
haemoglobin and pulse rate by measuring the absorption of selected wavelengths of
light. The light generated in the probe passes through the tissue and is converted into
electrical signals by the photodetector in the probe. The SpO2 module processes the
electrical signal and displays a waveform and digital values for SpO2 and pulse rate.

This device is calibrated to display functional oxygen saturation. It provides following

measurements.

(1)

(2)

(3) (4) (5)

(1) Pleth waveform (Pleth): visual indication of patient’s pulse. The waveform is not
normalized.
(2) Perfusion indicator: the pulsatile portion of the measured signal caused by arterial
pulsation.
(3) Oxygen saturation of arterial blood (SpO2): percentage of oxygenated hemoglobin in
relation to the sum of oxyhemoglobin and deoxyhemoglobin.
(4) Perfusion index (PI): gives the numerical value for the pulsatile portion of the
measured signal caused by arterial pulsation. PI is an indicator of the pulsatile
strength. You can also use it to assess the quality of SpO2 measurement.
 Above 1 is optimal.
 between 0.3 and 1 is acceptable.
 Below 0.3 indicates low perfusion. When PI is below 0.3, a question mark (?) is
displayed to the right of the SpO2 value, indicating that the SpO2 value may be
inaccurate. Reposition the SpO2 sensor or find a better site. If low perfusion
persists, choose another method to measure oxygen saturation if possible.
PI is available for Mindray SpO2 module and Masimo SpO2 module. For Mindray SpO2
module, PI value can be displayed under the PR value in larger characters if [PI Zoom]
is enabled.
(5) Pulse rate (derived from pleth wave): detected pulsations per minute.

7-1
 NOTE

 If the message "SpO2 Low Perf." or "SpO2 Weak Pulse" displays, check sensor
application, re-apply or remove the sensor if necessary, to obtain a better
signal.
 A function tester or SpO2 simulator can be used to verify the sensor functions.
 A functional tester or SpO2 simulator cannot be used to assess the accuracy of a
SpO2 module or a SpO2 sensor.
 A functional tester or SpO2 simulator can be used to determine the pulse rate
accuracy.

7.2 Safety

WARNING
 Use only SpO2 sensors specified in this manual. Follow the SpO2 sensor’s
instructions for use and adhere to all warnings and cautions.
 When a trend toward patient deoxygenation is indicated, blood samples should
be analyzed by a laboratory co-oximeter to completely understand the patient’s
condition.
 Do not use SpO2 sensors during magnetic resonance imaging (MRI). Induced
current could potentially cause burns. The sensor may affect the MRI image,
and the MRI unit may affect the accuracy of the oximetry measurements.
 Prolonged continuous monitoring may increase the risk of undesirable changes
in skin characteristics, such as irritation, reddening, blistering or burns. Inspect
the sensor site every two hours and move the sensor if the skin quality changes.
Change the application site every four hours. For neonates, or patients with
poor peripheral blood circulation or sensitive skin, inspect the sensor site more
frequently.

7.3 Identifying SpO2 Module

To identify which SpO2 module is incorporated into your monitor, see the company logo
located at the side panel. The color of the cable connector matches the company as
shown below:
 Mindray SpO2 module: a blue connector without logo.
 Masimo SpO2 module: a purple connector with a logo of Masimo SET.
 Nellcor SpO2 module: a grey connector with a logo of Nellcor.

The connectors for these three SpO2 sensors are mutually exclusive.

7-2
7.4 Applying the Sensor

WARNING
 If the sensor is too tight because the application site is too large or becomes too
large due to edema, excessive pressure for prolonged periods may result in
venous congestion distal from the application site, leading to interstitial edema
and tissue ischemia.

NOTE

 Place the SpO2 sensor so that the light source is against the application site.
 Check if the sensor is in normal condition before monitoring. Do not use the
SpO2 sensor if the package or the sensor is found damaged.
 Do not apply the sensor on a limb with an intravenous infusion or arterial
catheter in place.

1. Select an appropriate sensor according to the module type, patient category and
weight.
2. Clean the application site. For example, remove colored nail polish.
3. Apply the sensor to the patient.
4. Select an appropriate adapter cable according to the connector type and plug this
cable into the SpO2 connector.
5. Connect the sensor cable to the adapter cable.

7.5 Changing SpO2 Settings

7.5.1 Accessing SpO2 Menu
By selecting the SpO2 parameter or waveform area, you can access the [SpO2 Setup]
menu.

7.5.2 Adjusting the Desat Alarm

The Desat alarm is a high level alarm notifying you of potentially life threatening drops in
oxygen saturation.

Select [Alarm Setup >>] from the [SpO2 Setup] menu. From the pop-up menu, you can
set low alarm limit and alarm switch for [Desat]. When the SpO2 value is below the Desat
alarm limit and Desat alarm switch is set to [ON], the message [SpO2 Desat] is displayed.

7-3
7.5.3 Setting SpO2 Sensitivity
For Mindray SpO2 module, you can set [Sensitivity] to [High], [Med] or [Low] in the [SpO2
Setup] menu; for Masimo SpO2 module, you can set [Sensitivity] to [Maximum] or
[Normal] in the [SpO2 Setup] menu.

When the sensitivity is set to [High] or [Maximum], the equipment is more sensitive to
minor signals. When monitoring critically ill patients whose pulsations are very weak, it is
strongly recommended that the sensitivity is set to [High] or [Maximum]. When
monitoring neonatal or non-critically ill patients who tend to move a lot, noise or invalid
signals may be caused. In this case, it is recommended that the sensitivity is set to [Low]
or [Normal] so that the interference caused by motion can be filtered and therefore the
measurement stability can be ensured.

7.5.4 Changing Averaging Time

The SpO2 value displayed on the monitor screen is the average of data collected within a
specific time. The shorter the averaging time is, the quicker the equipment responds to
changes in the patient’s oxygen saturation level. Contrarily, the longer the averaging time
is, the slower the equipment responds to changes in the patient’s oxygen saturation level,
but the measurement accuracy will be improved. For critically ill patients, selecting
shorter averaging time will help understanding the patient’s state.

To set the averaging time:

 For Mindray SpO2 module, select [Sensitivity] in the [SpO2 Setup] menu and
then toggle between [High], [Med] and [Low], which respectively correspond to
7 s, 9 s and 11 s.
 For Masimo SpO2 module, select [Averaging] in the [SpO2 Setup] menu and then
toggle between [2-4 s], [4-6 s], [8 s], [10 s], [12 s], [14 s] and [16 s].

7.5.5 Monitoring SpO2 and NIBP Simultaneously

When monitoring SpO2 and NIBP on the same limb simultaneously, you can switch [NIBP
Simultaneous] on in the [SpO2 Setup] menu to lock the SpO2 alarm status until the NIBP
measurement ends. If you switch [NIBP Simultaneous] off, low perfusion caused by NIBP
measurement may lead to inaccurate SpO2 readings and therefore cause false
physiological alarms.

7.5.6 Sat-Seconds Alarm Management

With traditional alarm management, high and low alarm limits are set for monitoring
oxygen saturation. During monitoring, as soon as an alarm limit is violated, an audible
alarm immediately sounds. When the patient % SpO2 fluctuates near an alarm limit, the
alarm sounds each time the limit is violated. Such frequent alarm can be distracting.
Nellcor’s Sat-Seconds alarm management technique is used to reduce these nuisance
alarms.

7-4
The Sat-Seconds feature is available with the Nellcor SpO2 module to decrease the
likelihood of false alarms caused by motion artifacts. To set the Sat-Seconds limit, select
[Sat-Seconds] in the [SpO2 Setup] menu and then select the appropriate setting.

With Sat-Seconds alarm management, high and low alarm limits are set in the same way
as traditional alarm management. A Sat-Seconds limit is also set. The Sat-Seconds limit
controls the amount of time that SpO2 saturation may be outside the set limits before an
alarm sounds. The method of calculation is as follows: the number of percentage points
that the SpO2 saturation falls outside the alarm limit is multiplied by the number of
seconds that it remains outside the limit. This can be stated as the equation:

Sat-Seconds= Points × Seconds

Only when the Sat-Seconds limit is reached, the monitor gives a Sat-Seconds alarm. For
example, the figure below demonstrates the alarm response time with a Sat-Seconds limit
set at 50 and a low SpO2 limit set at 90%. In this example, the patient % SpO2 drops to 88%
(2 points) and remains there for 2 seconds. Then it drops to 86% (4 points) for 3 seconds,
and then to 84% (6 points) for 6 seconds. The resulting Sat-Seconds are:

% SpO2 Seconds Sat-Seconds

2× 2＝ 4
4× 3＝ 12
6× 6＝ 36
Total Sat-Seconds= 52

SpO2％

Seconds
After approximately 10.9 seconds, a Sat-Second alarm would sound, because the limit of
50 Sat-Seconds would have been exceeded.

7-5
 Saturation levels may fluctuate rather than remaining steady for a period of several
seconds. Often, the patient % SpO2 may fluctuate above and below an alarm limit,
re-entering the non-alarm range several times. During such fluctuation, the monitor
integrates the number of %SpO2 points, both positive and negative, until either the
Sat-Seconds limit is reached, or the patient%SpO2 re-enters the non-alarm range and
remains there.

7.5.7 Changing the Speed of Pleth Wave

In the [SpO2 Setup] menu, select [Sweep] and then select the appropriate setting. The
faster the waveform sweeps, the wider the waveform is.

7.5.8 Setting the Alarm Level for SpO2 Sensor Off Alarm
In the [SpO2 Setup] menu, select [SpO2 Sensor Off Lev.] and then select the appropriate
setting.

7.6 Measurement Limitations

If you doubt the measured SpO2, check patient vital signs first. Then check the equipment
and SpO2 sensor. The following factors may influence the accuracy of measurement:
 Ambient light
 Physical movement (patient and imposed motion)
 Diagnostic testing
 Low perfusion
 Electromagnetic interference, such as MRI environment
 Electrosurgical units
 Dysfunctional haemoglobin, such as carboxyhemoglobin (COHb) and
methemoglobin (MetHb)
 Presence of certain dyes, such as methylene and indigo carmine
 Inappropriate positioning of the SpO2 sensor, or use of incorrect SpO2 sensor
 Drop of arterial blood flow to immeasurable level caused by shock, anemia, low
temperature or vasoconstrictor.

7-6
7.7 Masimo Information

 Masimo Patents
This device is covered under one or more the following U.S.A. patents: 5,758,644,
6,011,986, 6,699,194, 7,215,986, 7,254,433, 7,530,955 and other applicable patents listed
at: www.masimo.com/patents.htm.

 No Implied License
Possession or purchase of this device does not convey any express or implied license to
use the device with unauthorized sensors or cables which would, alone, or in combination
with this device, fall within the scope of one or more of the patents relating to this device.

7.8 Nellcor Information

 Nellcor Patents
This device may be covered by one or more of the following US patents and foreign
equivalents: 5,485,847, 5,676,141, 5,743,263, 6,035,223, 6,226,539, 6,411,833, 6,463,310,
6,591,123, 6,708,049, 7,016,715, 7,039,538, 7,120,479, 7,120,480, 7,142,142, 7,162,288,
7,190,985, 7,194,293, 7,209,774, 7,212,847, 7,400,919.

 No Implied License
Possession or purchase of this device does not convey any express or implied license to
use the device with unauthorized replacement parts which would, alone, or in
combination with this device, fall within the scope of one or more of the patents relating
to this device.

7-7
FOR YOUR NOTES

7-8
8 Monitoring PR

8.1 Overview
The pulse numeric counts the arterial pulsations that result from the mechanical activity
of the heart. The pulse value can be from SpO2 or NIBP. The PR parameter area displays its
source.

(1) (3)
(2)

(4)
(1) PR high limit
(2) PR low limit
(3) Pulse rate (PR): detected pulsations per minute.
(4) PR Source

NOTE

 A function tester or SpO2 simulator can be used to determine the pulse rate
accuracy.

8.2 PR Source
The current pulse source is displayed in the PR parameter area. The pulse rate is:
 stored in the monitor’s database and reviewed in the graphic/tabular trends.
 sent via the network to the central monitoring system, if available.

8.3 Pulse Tone

You can change the pulse tone volume by adjusting [Beat Volume] in the [SpO2 Setup]
menu. When a valid SpO2 value exists, the system will adjust the pitch tone of pulse
according to the SpO2 value.

8-1
FOR YOUR NOTES

8-2
9 Monitoring NIBP

9.1 Overview
The monitor uses the oscillometric method for measuring the non-invasive blood
pressure (NIBP). This measurement can be used for adults, pediatrics and neonates.

Automatic non-invasive blood pressure monitoring uses the oscillometric method of

measurement. To understand how this method works, we’ll compare it to the auscultative
method.

With auscultation, the clinician listens to the blood pressure and determines the systolic
and diastolic pressures. The mean pressure can then be calculated with reference to these
pressures as long as the arterial pressure curve is normal.

Since the monitor cannot hear the blood pressure, it measures cuff pressure oscillation
amplitudes. Oscillations are caused by blood pressure pulses against the cuff. The
oscillation with the greatest amplitude is the mean pressure. This is the most accurate
parameter measured by the oscillometric method. Once the mean pressure is determined,
the systolic and diastolic pressures are calculated with reference to the mean.

Simply stated, auscultation measures systolic and diastolic pressures and the mean
pressure is calculated. The oscillometric method measures the mean pressure and
determines the systolic and diastolic pressures.

As specified by IEC80601-2-30 NIBP measurement can be performed during

electro-surgery and discharge of defibrillator.

NIBP diagnostic significance must be decided by the doctor who performs the
measurement.

NOTE

 Blood pressure measurements determined with this device are equivalent to

those obtained by a trained observer using the cuff/stethoscope auscultatory
method or an intra-arterial blood pressure measurement device, within the
limits prescribed by the American National Standard, Manual, electronic, or
automated sphygmomanometers.

9-1
9.2 Safety

WARNING
 During NIBP measuring, the inflated cuff will apply pressure on the application
site. The clinician shall determine if NIBP measuring is suitable for the patient.
 Be sure to select the correct patient category setting for your patient before
measurement. Do not apply the higher adult settings for pediatric or neonatal
patients. Otherwise it may present a safety hazard.
 Do not measure NIBP on patients with sickle-cell disease or any condition
where skin damage has occurred or is expected.
 Use clinical judgement to determine whether to perform frequent unattended
blood pressure measurements on patients with severe blood clotting disorders
because of the risk of hematoma in the limb fitted with the cuff.
 Do not use the NIBP cuff on a limb with an intravenous infusion or arterial
catheter in place. This could cause tissue damage around the catheter when the
infusion is slowed or blocked during cuff inflation.
 NIBP measurements can be affected by the measurement site, the position of
the patient, patient movement, or the patient's physiologic condition. If the
NIBP measurement seems out of range or inaccurate, determine the patient’s
vital signs by alternative means and then verify that the monitor is working
correctly.
 Make sure the air hose connecting the NIBP cuff and the monitor is not blocked,
twisted, or tangled.
 Do not apply the cuff on the arm on the side of a mastectomy.
 Continuous cuff pressure due to connection tubing kinking may cause blood
flow interference and resulting harmful injury to the patient.
 Devices that exert pressure on tissue have been associated with purpura,
ischemia, and neuropathy. Inspect the application site regularly to ensure skin
quality and inspect the extremity of the cuffed limb for normal color, warmth
and sensitivity. If the skin quality changes, or if the extremity circulation is
being affected, move the cuff to another site or stop the blood pressure
measurements immediately. Check more frequently when making automatic or
STAT measurements. Auto NIBP measurements with one and two minute
intervals are not recommended for extended periods of time.

9-2
9.3 Measurement Limitations
Measurements are impossible with heart rate extremes of less than 40 bpm or greater
than 240bpm, or if the patient is on a heart-lung machine.

The measurement may be inaccurate or impossible:

 If arterial pressure pulses are hard to detect
 In the presence of excessive and continuous patient movement such as
shivering or convulsions
 During certain cardiac arrhythmias
 For pregnant or pre-eclamptic patients
 Rapid blood pressure changes
 Severe shock or hypothermia that reduces blood flow to the peripheries
 Obesity, where a thick layer of fat surrounding a limb dampens the oscillations
coming from the artery

9.4 NIBP Measurement Mode

There are the following modes of measuring NIBP:
 Manual: measurement on demand.
 Auto: continually repeated measurements at set intervals.
 STAT: continually rapid series of measurements over a five minute period, then
return to the previous mode.
 Program: continually automatic measurement at set durations and intervals.

To set NIBP measurement mode, select NIBP parameter area to access [NIBP Setup]
menu:
 Select [Interval] to select manual mode or auto NIBP measurement interval.
 Select [NIBP STAT] to start a continuous NIBP measurement.

9-3
9.5 Measuring NIBP
9.5.1 Preparing the Patient
In order to minimize NIBP measurement errors, whenever possible check that the patient:
 Is comfortably seated
 Has legs uncrossed
 Has feet flat on the floor
 Has back and arm supported, and
 The middle of the cuff at the level of the right atrium of the heart.

NOTE

 It is recommended that the patient relax as much as possible before the NIBP
measurement is performed and that the patient does not talk during
measurement.
 It is recommended that the patient sit still for 5 min before the first
measurement is taken.
 The operator should not touch the cuff and tubing during the NIBP
measurement.

9.5.2 Preparation to Measure NIBP

1 Power on the monitor.

2. Verify that the patient category is correct. If not, select the hardkey →
[Patient Demographics]→[Patient Category] and set the patient category to
[Adult], [Pediatric] or [Neonatal].
3. Connect the NIBP hose to the monitor.
4. Select the appropriate sized cuff by referring to the limb circumference marked on
the cuff.
The width of the cuff should be 40% (50% for neonates) of the limb circumference, or
2/3 of the upper arm’s length. The inflatable part of the cuff should be long enough
to encircle at least 50% to 80% of the limb.
5. Apply the cuff to an upper arm or thigh of the patient and make sure the Φ marking
on the cuff matches the artery location. Do not wrap the cuff too tightly around the
limb. It may cause discoloration, and ischemia of the extremities. Make sure that the
cuff edge falls within the marked range. If it does not, use a cuff that fits better.
6. Connect the cuff to the air tubing and make sure that the bladder inside the cover is
not folded and twisted. Air must pass unrestricted through the tubing.

9-4
 WARNING
 Sustained cuff pressure due to a kinked hose may interfere with blood flow and
could lead to patient injury.

NOTE

 The use of the equipment is restricted to one patient at a time.

9.5.3 Starting NIBP measurement

Start NIBP measurement by one of the following ways:

 Press the hardkey on the monitor’s front panel

 Access [NIBP Setup] menu, and then select [Start NIBP] key to start a manual,
programmed or automatic NIBP measurement with preset interval.
 Access [NIBP Setup] menu, and then select [NIBP STAT] to start a continuous
NIBP measurement.

WARNING
 Continuous non-invasive blood pressure measurements may cause purpura,
ischemia and neuropathy in the limb with the cuff. Inspect the application site
regularly to ensure skin quality and inspect the extremity of the cuffed limb for
normal color, warmth and sensitivity. If any abnormity occurs, move the cuff to
another site or stop the blood pressure measurements immediately.

9.5.4 Stopping NIBP Measurement

 Press the hardkey on the monitor’s front panel to stop a manual NIBP
measurement, or a continuous NIBP measurement.
 Access [NIBP Setup] menu and then select [Stop All] to stop all the NIBP
measurement, including manual, continuous, and auto NIBP measurement.

9.5.5 Correcting the Measurement if Limb is not at Heart Level

The cuff should be applied to a limb at the same level as the patient’s heart. If the limb is
not at the heart level, to the displayed value:
 Add 0.75 mmHg (0.10 kPa) for each centimetre higher, or
 Deduct 0.75 mmHg (0.10 kPa) for each centimeter lower.

9-5
9.6 Understanding the NIBP Numerics
The NIBP display shows numerics only as below. Your display may be configured to look
slightly different.
(2) (3) (4)

(1) 5 6 7

(5) (6) (7)

(1) Unit of pressure: mmHg or kPa

(2) Systolic pressure
(3) Diastolic pressure
(4) Mean pressure obtained after the measurement and cuff pressure obtained during
the measurement
(5) Time of last measurement
(6) Time remaining to next measurement
(7) Measurement mode

9.7 Setting NIBP

Select NIBP parameter area to access the [NIBP Setup] menu.

9.7.1 Setting Interval

In [NIBP Setup] menu, you can select [Interval] and set to:
 [Manual]: NIBP measurement is started manually.
 [1 min], [2 min], [2.5 min], [3 min], [5 min], [10 min], [15 min], [20 min], [30 min],
[1 h], [1.5 h], [2 h]: The monitor automatically measures NIBP based on the
specified time interval.
 [Program 1] and [Program 2]: The monitor automatically measures NIBP based
on a program configured by user.

9.7.2 Setting the Initial Cuff Inflation Pressure

You can set the initial cuff inflation pressure manually. In the [NIBP Setup] menu, select
[Initial Pressure] and then select the appropriate setting.

The initial inflation pressure range is as follows:

9-6
 Patient Category Range (mmHg) Default (mmHg)
Adult 80 - 280 160
Pediatric 80 - 210 140
Neonate 60 - 140 90

NOTE
 For known hypertensive patients, you need to set initial cuff pressure to a
higher value to reduce the measurement time.

9.7.3 Setting NIBP End Tone

The monitor can issue a reminder tone at the completion of NIBP measurement. The NIBP
End Tone is off by default. You can switch it on by accessing the [NIBP Setup] menu.

9.7.4 Switching On/Off Measurement on Clock

In auto measuring mode, if the clock is enabled, the NIBP automatic measurement
interval will be synchronized with the real time clock.

For example, if [Clock] is set to [On], and [Interval] is set to [20min], and then you start an
NIBP auto measurement at 14: 03, the next measurement will be taken at 14: 20, and the
following measurement time will be 14:40, 15:00 and so on.

9.7.5 Configuring a Custom Program

In [NIBP Setup] menu, you can select [Custom Program>>] and configure the duration
of automatic measurement cycle, and the time interval between two NIBP measurement.
You can define two programs, respectively program 1 and program 2. Each program can
at most include five cycles: A, B, C, D, and E. In each cycle, the [Duration] and [Interval]
can be set individually.

You shall start the programmed NIBP measurement manually, and then the monitor will
automatically perform the measurement based on the cycle and interval you have
defined.

9-7
 When the programmed NIBP measurement is in use, the NIBP parameter area displays as
follows:

(1) (2) (3) (4) (5)

(1) Time of last measurement

(2) Time remaining to next measurement
(3) Program name
(4) Cycle name
(5) NIBP measurement Interval

9.7.6 Setting NIBP Alarm Properties

Select [Alarm Setup>>] from [NIBP Setup] menu. You can set the alarm properties for
this parameter in the popup menu.

9.7.7 Setting the Pressure Unit

1. Select [Main]→[General Setup >>]→[Unit Setup >>].
2. In the popup menu, select [Pressure] and toggle between [mmHg] and [kPa].

9-8
9.8 Assisting Venous Puncture
You can use the NIBP cuff to cause sub-diastolic pressure to block the venous blood vessel
and therefore help venous puncture.
1. Select [VeniPuncture >>] from the [NIBP Setup] menu. In the popup menu, verify
that the [Cuff Press.] value is appropriate. Change it if necessary.
2. Select [VeniPuncture] key.
3. Puncture vein and draw blood sample.

4. When the puncture is complete, select [VeniPuncture] key, or press the

hardkey on the monitor's front panel to deflate the cuff. The cuff deflates
automatically after a set time if you do not deflate it.

During puncture, the NIBP display shows the real-time inflation pressure of the cuff,
destination inflation pressure, and the remaining time in venous puncture mode.

9-9
FOR YOUR NOTES

9-10
10 Monitoring Temp

The monitor can measure temperature with any one of the following temperature
modules:
 SmarTempTM module
 THP79JU ear thermometer
 Convidien Genius TM 2 tympanic tethered thermometer

10.1 Monitoring Temp with SmarTemp™ Module

The SmarTemp™ Temp module is intended for monitoring oral, axillary and rectal
temperature of adult and pediatric patients and axillary temperature of neonatal patients.

Temperature can be measured in either Predictive mode or Monitor mode. The default is
Predictive mode.

WARNING
 Do not take oral temperature on the infant (0-3 years).
 Do not take rectal temperature on the neonate (0-28 days).
 Use only the specified temperature probe and probe cover. Using other probe
or probe cover, or not using probe cover may cause damage to the monitor or
failure to meet the declared specifications in this manual.
 The temperature probe cover is disposable. Re-use of probe cover may result in
patient cross-contamination.
 Use disposable probe covers for temperature measurement. Failure to use a
probe cover can cause inaccurate temperature readings, and patient
cross-contamination.
 Check the disposable probe cover for damage before using. Never use any
probe cover for temperature measurement in case of damage or contamination.
 Be careful to avoid damaging the temperature probe. Place the temperature
probe in the probe well if not in use.
 Prior to taking a temperature, instruct the patient not to bite down on the
probe, as patient injury and damage to the probe may result.
 In the rectal mode, incorrect probe placement may result in bowel perforation.
 Wash hands after temperature is taken. This will significantly reduce the risk of
cross contamination and nosocomial contamination.
 Ensure that probe covers are disposed of according to local regulations or
hospital's requirements.
 Accuracy verification of the temperature module is required every two years or

10-1
 WARNING
according to your hospital’s policy. Please contact our Customer Service if
accuracy verification is needed.

NOTE
 Patient actions may interfere with oral temperature readings. Ingesting hot or
cold liquids, eating food, chewing gum, brushing teeth, smoking, or performing
strenuous activities may affect temperature readings for up to 20 minutes after
the activity has ended.
 In the axillary mode, the probe shall directly contact with patient’s skin.
Measuring through patient’s clothes or long-term exposure of patient’s armpit
to the air may result in inaccurate temperature reading.
 Choose appropriate probe according to patient type and measurement site.
Using the incorrect probe may cause patient's discomfort and inaccurate
measurements.
 Improper use of probe may also cause patient's discomfort and inaccurate
measurements.

10.1.1 Setting Temp

Select Temp parameter area to access [Temp Setup] menu. You can set:
 Temp type: [Predictive] or [Monitor].
 Temperature measurement site: the measurement site is related to the probe
type. When using oral/axillary probe, you can select the site [Oral] and [Axillary];
when using rectal probe, you can select [Rectal].

You can select the temperature type and measurement site only when the probe is in the
probe well.

10.1.2 Measuring Temp

10.1.2.3 Selecting Measuring Site
The temperature module can be configured with 2 types of temperature probe:
 oral/axillary probe (blue), and
 rectal probe (red)

The blue oral/axillary probe shall only be used with blue probe well, while the red rectal
probe shall only be used with red well.

Be sure to select correct probe according to the measurement site.

10-2
  Oral/Axillary probe: This type of probe is intended for taking oral or axillary
temperature of adult and pediatric patients, or axillary temperature of neonatal
patient.
 Rectal probe: This type of probe is intended for taking rectal temperature of
adult and pediatric patient.

When oral/axillary probe is used, the measurement site will automatically be set to [Oral].
You can change the site in [Temp Setup] menu.

10.1.2.4 Taking a Temperature in Predictive Mode

1. Verify that the probe is placed in the probe well.
2. Verify that the temperature measurement type and site are correct.
3. Unplug the probe from the probe well and insert it into a cover in the probe cover
pack. Press the probe handle down firmly until the cover engages with the probe.
The temperature module starts to warm up when the probe is taken out. The
message "Temp Warming Up" displays in Temp parameter area. The warming up time
is about 2 seconds in room temperature. The monitor issues two beeps and provides
the message "Temp Prediction Ready" on the screen when warm-up is complete.
Then you can place the probe at measurement site.
4. Place the probe at measurement site and wait till the measurement stabilizes. When

the dynamic symbol appears, it indicates that the monitor starts to take the
measurement.
 When taking an oral temperature, apply the probe under the patient’s tongue
from either side of the mouth. Verify that the probe reaches the rear sublingual
pocket. Have the patient close his/her lips to hold the probe. Hold the probe in
place. Make sure that the probe contacts with the patient’s oral tissue
throughout the measurement.
 When taking an axillary temperature, lift the patient’s arm to expose the entire
armpit. Apply the probe as high as possible in the armpit. Check that the probe
tip is completely surrounded by the axillary tissue. Lower the patient’s arm so
that it is tightly placed at the patient side. Keep the patient’s arm and the probe
in place throughout the measurement.
 When taking a rectal temperature, separate patient's buttocks with one hand,
and the probe 1.5 cm inside the rectum with the other hand. For pediatric
patient, depth of insertion shall be less. Tilt the probe so that it always contacts
with patient’s tissue. Lubricant can be used in rectal mode.
The monitor will give a beep as the temperature measurement is complete. The
temperature reading displays continuously until the probe is taken out from the
probe well.
5. Withdraw the probe. Press firmly the ejection button on the top of the probe to eject
the probe cover. Replace the probe into the probe well.

10-3
 In Predictive mode, the monitor automatically enters Monitor mode in the following
cases:
 Accurate temperature is not reached.
 Neither measurement is taken nor is the probe replaced in the probe well in 60
seconds after the probe is withdrawn from the well.

The temperature type automatically changes to Predictive mode when the probe returns
to the probe well.

NOTE
 In Predictive mode, temperature probe shall be placed to the measurement site
as soon as probe warmup is complete; otherwise, inaccurate temperature
reading may result.
 In Predictive mode, if the probe has a high temperature due to the
environmental temperature or other causes, cool the probe and then measure
the patient's temperature.

10.1.2.5 Taking a Temperature in Monitor Mode

To measure a temperature in the Monitor mode,
1. Verify that the probe is placed in the probe well.
2. Verify that the temperature measurement type and site are correct.
3. Unplug the probe from the probe well and insert it into a cover in the probe cover
pack. Press the probe handle down firmly until the cover engages with the probe.
4. Place the probe to the measurement site and then start measuring. Refer to Step 4 in
10.1.2.4 Taking a Temperature in Predictive Mode for how to place a probe.
5. Withdraw the probe. Press firmly the ejection button on the top of the probe to eject
the probe cover. Replace the probe into the probe well.

NOTE
 In Monitor mode, record the measured value prior to taking away the probe
from measurement site. The monitor will automatically stop measuring
temperature after 10 minutes from the start of the measurement.

10.1.3 Disinfecting Temperature Probe

The recommended disinfectants include: ethanol 70%, isopropanol 70%,
glutaraldehyde-type 2% liquid disinfectants.

To disinfect the temperature probe:

1. Disconnect the temperature probe from Temp connector.

10-4
 2. Disinfect the probe with a soft cloth dampened with the recommended disinfectant.
3. Wipe off all the remaining disinfectants from the probe with a soft cloth dampen
with water.
4. Dry the probe in a cool place.

WARNING
 Perform the decontamination or cleaning process with the monitor powered
down and power cord removed.
 The used soft cloth shall be properly disposed of.

10.2 Monitoring Temp with THP79JU Infrared Ear

Thermometer
The THP79JU infrared ear thermometer measures an ear temperature and transfers it to
the monitor. The monitor displays and stores the transferred temperature measurement.

Read the ear thermometer manufacturer’s instructions for use before attempting to
configure, use, troubleshoot, or maintain the thermometer.

WARNING
 No alarm is provided for the ear temperature measurement.

CAUTION
 Do not submerge the thermometer probe into liquids or expose it to direct
moisture.
 The ear thermometer may not function properly if dropped or damaged. When
transporting the monitor by hand, properly secure the thermometer cable to
keep the cable from dragging and to avoid thermometer dropping.

10.2.1 Measuring Temperature

10.2.1.1 Connecting the Thermometer to the Monitor

CAUTION
 Improper plug connection may damage the ear thermometer.

10-5
 To connect the ear thermometer to the monitor:
1. With the arrow-marked side of the plug face up, insert the plug into the ear
thermometer connector.

2. Lock the plug by turning the plug.

3. Place the ear thermometer on the dock.

10.2.1.2 Installing a Probe Cover Package

To install the probe cover package into the temperature dock:

1. Remove the ear thermometer from the dock.
2. Remove the probe cover loader by pressing the button on the right side of the dock
and moving the loader forwards.

3. Rotate the loader cap counterclockwise, and then lift the cap.

10-6
 4. Place the probe cover package on the loader, and take away the slip to let the probe
covers fall into the loader.

NOTE

 It is recommended to quickly take away the slip to prevent the probe covers
from turning over in the loader.

5. Push down the cap. Make sure that the cap is aligned with the notch on the loader.
Then turn clockwise to lock the cap.
6. Push back the loader into the dock.
7. Replace the ear thermometer to the dock.

10.2.1.3 Taking an Ear Temperature

WARNING
 Do not reuse the probe cover. Always use a new, undamaged and clean probe
cover for a measurement.
 Use only the specified probe cover.

To take an ear measurement and transfer it to the monitor:

1. Power on the monitor.
2. Remove the ear thermometer from the dock.
3. Slide the lever to the end. A probe cover comes out when sliding the lever.
4. Release the lever.
5. Firmly press the probe tip into the probe cover until you hear a click.

10-7
 6. Press ‘‘ON/MEM’’ button on the thermometer. When the thermometer is ready for
measuring, the icon continuously displays on the thermometer LCD and two
beeps sound.
7. Gently pull the patient ear back to straighten the ear canal and position the probe
into the ear canal towards the membrane of the eardrum.
8. Press the black ‘‘Scan’’ button on the back of the thermometer for 1 second until you
hear a long beep sound. Then you can read the temperature measurement from the
thermometer and the monitor.
9. When you finish measuring, push up the probe cover ejector, and remove the used
probe cover.
10. Replace the thermometer to the dock.

When the monitor receives a measurement, the monitor displays and stores the
measurement.

10.2.2 Understanding the Numerics

(1) (2)

(5)

(4) (3)

(1) Thermometer On: The ear thermometer is turned on and connected to the monitor.
(2) Measurement site
(3) Temperature reading
(4) Alarm off
(5) Unit of measure: °C or °F

10-8
10.2.3 Troubleshooting

Message Cause Solution

The ear thermometer
Therm. battery low Replace the battery.
battery is low.
A measurement is taken
Take a measurement until all the
Therm. is not ready before the ear thermometer
icons stop flashing.
stabilizes.
Ambient temp The environment Use the thermometer in an
changes fast temperature changes fast. environment of stable temperature.
The environmental Keep the thermometer from
Ambient temp out of temperature is out the range operating for at least 30 minutes at a
range of 10°C to 40°C (50°F to room temperature of 10°C to 40°C
104°F). (50°F to 104°F).
Therm. parameter
error
Unload the thermometer battery,
Therm. software error wait for one minute, and then
The ear thermometer is not
Therm. hardware repower the thermometer. If the
functioning properly.
error1 message reappears, contact us for
service.
Therm. hardware
error2

10.2.4 Cleaning and Disinfecting the Ear Thermometer

Refer to the THP79JU Infrared Ear Thermometer instructions for use for cleaning and
disinfection information.

10.3 Monitoring Temp with GeniusTM 2 Tympanic Tethered

Thermometer
The GeniusTM 2 tympanic tethered thermometer is a fast, accurate, and convenient clinical
instrument for measuring patient temperatures. The GeniusTM 2 thermometer is an ear
canal thermometer with measurement site equivalence modes including oral, core, and
rectal equivalent temperatures.

The thermometer is powered by the monitor.

10.3.1 Safety Information

10-9
 WARNING
 No alarm is provided for the temperature measurement.

CAUTION
 Used probe covers must be treated as infectious biological waste and disposed
of in accordance with current medical practices and local regulations.

10.3.2 Thermometer Buttons

Button Name Functions
Eject button Press the eject button to eject the probe cover from the probe.

°C/°F button When a temperature is in the display, you may press and hold
the °C/°F button to toggle between degrees Celsius and
degrees Fahrenheit.
Timer button Press and hold the timer button to enter the timer mode. Press
again to start the timer.

Scan button When the thermometer is on, press the scan button to initiate a
temperature measurement.
When the thermometer is off, press the scan button to turn on
the device.

10.3.3 Equivalence Mode Temperature

The thermometer can measure the ear temperature and acquire the equivalence
temperature.

A patient’s temperature at the site of mouth, rectum, or core would be slightly different
from the ear temperature. The thermometer compensates for the average difference in
temperature at each of these sites by adjusting the displayed temperature.

A checker/calibrator is available for this device. The device should be checked if it is

dropped or if it is stored at less than -25°C or above 55°C.

NOTE

 Only the authorized personnel can adjust the data for Genius 2 thermometer
equivalence modes.

10-10
Equivalence Description
Mode
Oral The temperature is adjusted to display an oral temperature equivalent.
Oral Mode = Ear Mode + 0.60°C (33.08°F)
Core The temperature is adjusted to display a core temperature equivalent.
Core Mode = Ear Mode + 1.04°C (33.87°F)
Rectal The temperature is adjusted to display a rectal temperature equivalent.
Rectal Mode = Ear Mode + 1.04°C (34.08°F)

10.3.4 Taking a Temperature

To take a temperature, follow this procedure:
1. When the monitor starts, remove the thermometer from the dock.
2. Inspect the probe tip and make sure that the probe tip is clean. If it is soiled, clean it
with a lens wipe or lint free swab.
3. Press the scan button to verify functionality and mode selection on the LCD screen.
4. Install a probe cover by firmly inserting the probe tip into a probe cover. Make sure
that the probe cover is fully seated.
5. Place the probe in the ear canal.
6. Once positioned lightly in the ear canal, press and release the scan button.
7. Remove the probe from the ear as soon as the triple beep is heard. The temperature
and probe eject icon display on the LCD screen.
8. Press the eject button to eject the probe cover.
9. Replace the thermometer to the base.

NOTE

 Always wait at least two minutes before taking another measurement in the
same ear.
 Do not configure the thermometer during the start-up of the monitor.
Otherwise, the thermometer data may conflict with the data that displays on
the monitor.

10-11
10.3.5 Temperature Display
Display on Monitor

(1) (2)

(5)
(3)
(4)

(1) Thermometer On: The thermometer is turned on and connected to the monitor.
(2) Site
(3) Temperature reading
(4) Alarm off
(5) Unit of measure: °C or °F

10.3.6 Troubleshooting

Message Cause Solution

The communication Eject and re-install the probe cover.
Temp comm abnormal between the monitor and And then measure the temperature
thermometer is abnormal. again.

10.3.7 Cleaning and Disinfecting the Tympanic Thermometer

Refer to the Genius 2 Tympanic Thermometer instructions for use for cleaning and
disinfection information.

10-12
11 Monitoring CO2

11.1 Overview
CO2 monitoring is a continuous, non-invasive technique for determining the
concentration of CO2 in the patient’s airway by measuring the absorption of infrared (IR)
light of specific wavelengths. CO2 has its own absorption characteristic and the amount of
light passing the gas probe depends on the concentration of the measured CO2. When a
specific band of IR light passes through respiratory gas samples, some of IR light will be
absorbed by the CO2 molecules. The amount of IR light transmitted after it has been
passed through the respiratory gas sample is measured with a photodetector. From the
amount of IR light measured, the concentration of CO2 is calculated.

The CO2 measurement is to monitor the patient’s respiratory status.

CO2 monitoring is intended for adult, pediatric and neonatal patients.

11.2 Safety

WARNING
 Remove the airway sampling line from the patient’s airway while nebulized
medications are being delivered.
 Leakage in the breathing or sampling system may cause the displayed EtCO2
values to be significantly low. Always make sure that all components are
securely connected.
 EtCO2 values measured from the CO2 module may differ from those of from the
blood gas analysis.
 Route all tubing away from the patient’s throat to avoid strangulation.
 Inspect the airway for a tight connection and make proper settings before
attaching it to the patient.
 Squeezing or bending the sampling line during the CO2 measurement may
cause inaccurate CO2 reading or no reading.

11.3 Measurement Limitations

The following factors may influence the measurement accuracy:
 Leaks or internal venting of sampled gas
 Mechanical shock
 Cyclic pressure up to 10 kPa (100 cmH2O)
 Other sources of interference, if any
11-1
 Measurement accuracy may be affected by the breath rate and inspiration/expiration
ratio (I: E ratio) as follow:
 EtCO2 value is within specification for breath rate ≤ 60 bpm and I/E ratio ≤ 1:1;
 EtCO2 value is within specification for breath rate ≤ 30 bpm and I/E ratio ≤ 2:1.

Measurement accuracy is unspecified for breath rate larger than 60 bpm.

11.4 CO2 Display

The CO2 parameter and waveform areas provide FiCO2 measurement, EtCO2 measurement,
awRR measurement, and a CO2 waveform.

(1) (2) (3)

5
(4)

(1) End tidal CO2 (EtCO2)

(2) Fraction of inspired CO2 (FiCO2)
(3) Airway respiration rate (RR)
(4) CO2 waveform
(5) Scale

11.5 Measuring CO2

CAUTION
 Eliminate the exhausted gas before performing the measurement.
 Connect an exhaust tube to the gas outlet connector of the monitor to vent the
calibration gases to a scavenging system.
 Check that the alarm limit settings are appropriate before taking measurement.

To measure CO2, follow this procedure:

1. Select the appropriate sampling line according to the patient category.
2. Connect the sampling line to the gas sampling port of the mini water trap by
clockwise turning.

11-2
3. Plug the mini water trap to the CO2 sampling line connector on the monitor.

Mini water trap

Sampling line

4. Connect the other end of the sampling line to the patient.

5. Connect the CO2 gas outlet to the scavenging system with an exhaust tube.

CO2 can be measured after the start-up is complete.

CAUTION
 The DRYLINE PRIME mini water trap is automatically blocked when its service
life is reached. Replace the DRYLINE PRIME mini water trap if the alarm ‘‘CO2:
Change Watertrap’’ occurs.
 The water trap has a filter preventing bacterium, water and secretions from
entering the module. Extended use could destroy the filter in water trap and fail
to stop the bacterium, water and secretions entering the module, result in
damaging the gas module and having infection risk.

11-3
NOTE

 To extend the lifetime of the mini water trap and module, disconnect the mini
water trap from the module and set the operating mode to Standby mode when
CO2 monitoring is not required.

11.6 Automatic CO2 Module Zeroing

The CO2 module performs zero calibration automatically when needed.

NOTE

 The CO2 module temporally stops measuring during zeroing.

11.7 Changing CO2 Settings

11.7.1 Changing CO2 Alarm Settings

To change the CO2 alarm settings, follow this procedure:
1. Select the CO2 numeric area or waveform area to enter the [CO2 Setup] menu.
2. Select [Alarm Setup>>].
3. Set the following alarm properties:
 Switch on or switch off the alarms.
 Adjust the alarm limits and alarm priority.

11.7.2 Setting the Apnea Alarm Delay

The monitor will alarm if the patient has stopped breathing for longer than the preset
Apnea time.

To set the Apnea delay time, follow this procedure:

1. Select the CO2 numeric area or waveform area to enter the [CO2 Setup] menu.
2. Select [Apnea Delay] and then select the appropriate setting.

11.7.3 Setting the CO2 Waveform

To set the CO2 waveform, follow this procedure:
1. Select the CO2 numeric area or waveform area to enter the [CO2 Setup] menu.
2. Set [Wave Type], [Sweep] and [Scale] of the CO2 waveform.

11-4
  Select [Wave Type] and toggle between [Draw] and [Fill].
[Draw]: The CO2 wave is displayed as a curved line.
 [Fill]: The CO2 wave is displayed as a filled area.
 Select [Sweep] and then select the appropriate setting. The faster the wave
sweeps, the wider the wave is.
 Select [Scale] and then change the size of the CO2 waveform.

11.7.4 Entering the Standby Mode

You can set the CO2 module to one of the following modes according to the module
status:
 Select [Measure] mode when you use the CO2 module for monitoring.
 Select [Standby] mode when you does not use the CO2 module to prolong the
serviece life of the CO2 module.

The default operating mode is [Measure]. If you are not using the CO2 module, you can
proceed as follows to enter the Standby mode:
1. Select the CO2 numeric area or waveform area to enter the [CO2 Setup] menu.
2. Set [Operating Mode] to [Standby].

11.7.5 Setting the Auto Standby

The monitor enters the standby mode automatically after the configured period of time if
no breath is detected since the last detected breath.

To set the auto standby, follow this procedure:

1. Select the CO2 parameter area or waveform area to enter the [CO2 Setup] menu.
2. Set [Auto Standby].

11.7.6 Setting Humidity Compensation

The CO2 modules is configured to compensate CO2 readings for either Body Temperature
and Pressure, Saturated Gas (BTPS), to account for humidity in the patient’s breath, or
Ambient Temperature and Pressure, Dry Gas (ATPD).
 ATPD: P co 2 ( mmHg )  CO 2 ( vol %)  P amb / 100

)  CO ( vol %)  ( P amb  47 ) / 100

 BTPS: P CO 2 ( mmHg 2

Where, PCO = partial pressure, vol % = CO2 concentration, P amb = ambient pressure,
2

and unit is mmHg.

To set the humidity compensation, follow this procedure:

1. Select the CO2 numeric area or waveform area to enter the [CO2 Setup] menu.

11-5
 2. Set [BTPS Compensation] to [On] or [Off].

11.7.7 Setting Gas Compensation

The presence of interfering gas affects the CO2 measurement. To get the best possible
measuring result, it is needed to set the gas compensation. The configured concentration
of the interfering gas should be in accordance with its actual proportion.

WARNING
 Make sure to use the appropriate compensations. Inappropriate compensations
may cause inaccurate measurement values and result in misdiagnosis.

To set the gas compensation, follow this procedure:

1. Select the CO2 numeric area or waveform area to enter the [CO2 Setup] menu.
2. Set the O2, N2O and AA compensation according to the actual amount of the
respective gas in the ventilation gas mixture.

11.7.8 Automatic Barometric Pressure

The CO2 module has the function of automatic barometric pressure compensation.

11.7.9 Calibrating the CO2 Module

A calibration should be performed once a year or when the readings go far beyond the
range. For details, refer to 16.6.3 Calibrating CO2.

11-6
12 Clinical Scoring

12.1 Overview
The Clinical Scoring function helps a clinician quickly determine the severity of illness of a
patient based on a calculated score, so that the clinician can take necessary measures
according to the indication provided by the Clinical Scoring function.

The monitor supports the following scorings:

 MEWS (Modified Early Warning Score)
 NEWS (National Early Warning Score)
 Customizable Score

WARNING
 The Clinical Score is intended to be used only by healthcare professionals and
to be serviced by trained personnel.
 The scores and clinical responses in the clinical scores are for reference and
cannot be used alone for diagnostic interpretation.
 Both MEWS and NEWS are not applicable to pregnant woman, COPD (Chronic
Obstructive Pulmonary Disease) patients and those under 16 years old.

12.1.1 MEWS (Modified Early Warning Score)

The MEWS calculates a total score and provides a clinical response based on the
following five parameters:
 Pulse Rate
 Systolic NIBP
 Respiration Rate
 Temperature
 AVPU (Alert, Reacting to Voice, Reacting to Pain, and Unresponsive)
This scoring is only applicable to adult.

12.1.2 NEWS (National Early Warning Score)

The NEWS calculates a total score and provides a clinical response based on the
following seven parameters:
 Respiration Rate
 SpO2
 Supplemental Oxygen

12-1
  Temperature
 Systolic NIBP
 Pulse Rate
 AVPU
This scoring is only applicable to adult.

12.1.3 Customizable Scoring

The customizable scoring can provides a clinical response based on the selected
multiple parameters or single parameter.
 Multiple parameter scoring: calculate a total score and provide a clinical
response based on the multiple parameters which are defined.
 Individual parameter scoring (IPS): provide a clinical response whenever any
individual parameter value is out of range.

The available parameters in customizable scoring include:

 Respiration Rate
 SpO2
 Supplemental Oxygen
 Temperature
 Systolic NIBP
 Pulse Rate
 Level of Consiousness (either AVPU or GCS)
 Blood Sugar
 Urine Output
 Catheter
 Pain Score
 Pain
 Inspired O2%
 Airway
 Three customizable parameters

The applicable patient category can be defined with the Mindray Clinical Scoring
Config Tool. Refer to Clinical Scoring Config Instruction for Use (P/N: 046-007126-00)
for customizable scorings.

12.2 Entering the Calculation Screen

You can calculate a score in the scoring screen or in the score tile.

12.2.1 Scoring Screen

Select [Scoring] QuickKey to access the Scoring screen.

12-2
12.2.2 Score Tile
The score tile is located in the main screen. By default, the scoring tile is not displayed. The
scoring tile will activate when you select a default scoring or load a scoring.

12.3 Calculating a Score

To calculate a score, follow this procedure:
1. Select the default scoring or load a scoring for the applicable patient category. Refer
to 12.6.2 Selecting Default Scoring or 12.6.4 Loading a Scoring.
2. Obtain the value of all parameters, and then total score will be automatically
calculated. Refer to 12.5 Obtaining the Total Score.
3. If necessary, record the scoring data. Refer to 12.4 Clinical Scoring Screen.

12.4 Clinical Scoring Screen

12.4.1 Score Tile in the Main Screen
The MEWS, NEWS and multi-parameter score tile display as following:
(1)
(3)

(2)

(1) Name for clinical score

(2) Total score: the background color indicates the current score level.
(3) Score level indicator
It indicates that the warning level increases from top to bottom. The current level is
enclosed in the square frame.

The IPS score tile displays as following:

(1)

(2)

(1) Name for clinical score

12-3
 (2) Score Status
 Red : indicates that at least one parameter is out of the defined range.
 White : indicates that all the parameters are within the normal range.

12.4.2 Scoring Screen

The MEWS, NEWS or multi-parameter score screen display as following:
(3)

(1)

(2)

(4)

(1) Icon for manual input

You need to manually input the parameter.
(2) Icon for real-time monitoring
The parameter value is from the monitor.
(3) Score for single parameter
(4) Recommended clinical response

The IPS score screen displays as following:

12-4
 (3)

(2)

(1)

(4)

(1) Icon for manual input

You need to manually input the parameter.
(2) Icon for real-time monitoring
The parameter value is from the monitor
(3) Score status for single parameter
 Red : indicates that the parameter is out of the defined range.
 White : indicates that the parameter is within the normal range.
(4) Recommended clinical response

In the above screens, you can:

 Select [Review] to open the patient review screen. Refer to 4.4 Reviewing Patient
Data for details.
 Select [Record] to print the current patient scoring data with a recorder.
 Select [Save] to save the scoring data in the [Results] screen. Refer to4.3
Manually Save Patient Data.
 Select [Exit] to go to the main screen.

12.5 Obtaining the Total Score

The IPS only calculates the parameter status. The IPS does not have total score.

For other scorings, the total score will automatically be calculated when each required

12-5
 parameter tile has a value. To calculate a score, follow this procedure:
1. Start monitoring parameters. Their values are automatically obtained.
2. Manually input the values for the parameters that are not monitored.

NOTE

 If the value is measured by the monitor, the value displays in grey. You cannot
manually input the value.
 When you are in the scoring screen, if an alarm for the monitoring parameter
occurs, the alarm indicators still can be seen in the monitor display.

The parameter input range is as follows:

Parameter Range
Pulse Rate 20 bpm -300 bpm
Systolic NIBP 40 mmHg -270 mmHg (Adult)
40 mmHg -200 mmHg (Pediatric)
40 mmHg -135 mmHg (Neonate)
Respiration Rate 0-150 rpm
Temperature 0.1°C --- 50.0°C (32.1°F --- 122.0°F)
Level of Consciousness AVPU: Alert, Reacting to Voice, Reacting to Pain,
Unresponsive
GCS: 1-15
Supplemental Oxygen Yes, No
SpO2 0% --- 100%
Urine Output 0 -300 mml/h (0 --- 10 ml/h/kg)
Catheter Yes, No
Blood Sugar 1.0 mg/dl -720.0 mg/dl (0.06 mmol/L -40.00 mmol/L)
Pain Score 0-10
Pain None, Mild, Moderate, Severe
Inspired O2% 21% -100%
Airway Clear, Obstruction
Customizable parameter The input range depends on the decimal point. The decimal
point is customizable in Mindray Clinical Scoring Config Tool.
0 --- 9999 (decimal point as 1)
0.0 --- 999.9 (decimal point as 0.1)
0.00 --- 99.99 (decimal point as 0.01)

12-6
12.6 Managing Scorings
12.6.1 Importing the Scoring
You can import MEWS, NEWS and customized scorings into the monitor. Up to five scoring
protocols can be imported into the monitor.
1. Connect the USB drive to the USB connector on the monitor.
2. Select [Main] →[Maintenance>>] →[User Settings>>]→Enter the required
password→[Manage Scoring>>]→[Import Scoring>>].
3. In the [Import Scoring] menu, select the scorings to be imported. Then select
[Import]. A status message will report completion of the import.

NOTE

 To load the customized scoring protocols to the USB drive, refer to Clinical
Scoring Config Instruction for Use (P/N: 046-007126-00).

12.6.2 Selecting Default Scoring

The monitor does not provide default scoring. To select a default scoring:
1. Select [Main] →[Maintenance>>] →[User Settings>>] →Enter the required
password→[Manage Scoring>>]→[Select Default Scoring>>].
2. Set the default scoring for the applicable patient category.

After the default scoring is set, when a patient category is changed, the monitor will
automatically use the default scoring.

12.6.3 Deleting the Scoring

To delete the scoring:
1. Select [Main]→[Maintenance>>]→[User Settings>>]→Enter the required
password→[Manage Scoring>>]→[Delete Scoring>>].
2. In the [Delete Scoring] menu, select the scoring to be deleted.
3. Select [Delete].

12.6.4 Loading a Scoring

The default scoring may not be appropriately for the new patient. You can load a scoring
so as that the scoring is appropriate for your patient.

To load a scoring:
1. Select [Scoring]→[Setup]→[Load Scoring>>].
2. Select the desired scoring to be loaded.
3. Select [Load Scoring].

12-7
FOR YOUR NOTES

12-8
13 Recording

13.1 Using a Recorder

The thermal recorder records patient information, parameters numerics (measured value
and manual input value), SpO2 waveforms (if configured), and so on.

(1) (2)

(5)
(3)

(4)

(1) Start/Stop key: press to start a recording or stop the current recording.
(2) Indicator
 On: when the recorder works properly.
 Off: when the monitor is switched off.
 Flash: when an error occurred to the recorder, e.g. the recorder runs out of
paper.
(3) Paper outlet
(4) Recorder door
(5) Latch

13.2 Loading Paper

1. Press the latch at the upper right of the recorder door to open the door.
2. Insert a new roll into the compartment as shown below.
3. Close the recorder door.
4. Check if paper is loaded correctly and the paper end is feeding from the top.

13-1
 Paper roll

CAUTION
 Use only specified thermal paper. Otherwise, it may cause damage to the
recorder’s printhead, the recorder may be unable to print, or poor print quality
may result.
 Never pull the recorder paper with force when a recording is in process.
Otherwise, it may cause damage to the recorder.
 Do not leave the recorder door open unless you are replacing the recorder
paper or removing a fault.

13.3 Setting the Recorder

Select [Main]→[General Setup >>]→[Print Setup >>] to access the [Print Setup] menu
and select the items as you want.

13.4 Starting and Stopping Recordings

To manually start a recording, you can either:
 Press hardkey on the recorder.
 Select [Record] key in graphic or tabular trend.

The monitor will automatically start recording when the [Save] QuickKey is selected to
save the manual input patient data if [Automatically Record on Manual Save] is enabled
from the [User Settings>>] menu.

To manually stop the current recording, you select hardkey.

Recordings stop automatically when:

 A recording is completed.

13-2
  The recorder runs out of paper.
 When the recorder has an alarm condition.

When a recording is stopped, the following markers will be added:

 Automatically stopped recording: print two columns of ‘*’ at the end of the
printout.
 Manually or abnormally stopped recording: print one column of ‘*’ at the end of
the printout.

13.5 Reports
13.5.1 Real-time Recording
Real-time recording strip includes recording time, parameter values displayed on the
screen, as well as SpO2 waveform, patient information and manual inputs as configured in
the [Print Setup] menu.

13.5.2 Graphic Trend Recording

Graphic trend strip includes patient information, recording time, and graphic trends of all
the parameters on the screen.

In graphic trends strip,

 The mark "A" is shown on the event time.
 The mark "?" indicates system time changes.

 NIBP measurement taken in Spot mode shows as ‘‘ ’’.

 The predictive temperature and PR (from NIBP) measurement show as ‘‘■’’.

13.5.3 Continuous Trends Recording

The continuous trend recording strip show a tabular which includes patient information,
recording time, measured value, the saving time for each measurement, and NIBP and
Temp complete time.

To print the continuous trends,

1. Choose one patient, and then select [Record] in the [Continuous Trends] screen.
2. Set the start and end time for the recording.
3. Select [Record] to start recording.

13-3
13.5.4 Spot Check Trends Recording
The spot check trends strip includes patient information, recording time, measured value
and measurement complete time. When [Filter] is set to [Manually Saved] or [All], the
manual input data can be recorded.

To print the spot check trends,

1. Select the patient and filter.
2. Select [Record].

If several patients are selected, the recorder will print the data in sequence. Data from
different patients are separated by vertical dashes.

13.6 Removing Paper Jam

If the recorder works incorrectly or produces unusual sound, check if there is a paper jam.
If a paper jam is detected, follow this procedure to remove it:
1. Open the recorder door.
2. Take out the paper and tear off the draped part.
3. Reload the paper and close the recorder door.

13.7 Cleaning the Recorder Printhead

If the recorder has been used for a long time, deposits of paper debris may collect on the
printhead compromising the print quality and shortening the lifetime of the roller. Follow
this procedure to clean the printhead:
1. Take measures against the static electricity such as Disposable Wrist Strap for the
work.
2. Open the recorder door and take out the paper.
3. Gently wipe around the printhead using cotton swabs dampened with alcohol.
4. After the alcohol has completely been dried, reload the paper and close the recorder
door.

CAUTION
 Do not use anything that may destroy the thermal element.
 Do not add unnecessary force to the thermal head.

13-4
14 Network

14.1 Network Connection

The monitor can be connected to the central station through the network.
 The monitor transmits waveforms and numerics of parameters (Temp, SpO2,
NIBP, CO2), related alarms and alarm settings, patient information, and
operating mode to the central station. The waveforms, numerics, alarms, alarm
settings, patient information, and operating mode displayed on central station
are consistent with the monitor.
 The central station transmits alarm settings, parameter settings, patient
information and operating mode settings (enter or exit the Standby mode) to
the monitor. The alarm settings, parameter settings, patients’ information and
operating mode settings of the monitor are consistent with central station.

The monitor can be connected to the ADT system and the EMR system through the
eGateway.
 The monitor transmits the query command message to the ADT system. When
the ADT system receives the query command message, the ADT system will
transmit the patients’ information to the monitor.
 The monitor transmits numerics of Temp, SpO2, NIBP, CO2, related alarms and
alarm settings, patient information, operating mode, and historical data,
including trends and events, to the EMR. When the EMR receives the data, the
EMR will send a success message to the monitor.

CAUTION
 Disconnecting from the network may result in data loss, including parameter
waveforms and measurements, alarm events, trends and patient data, or cause
functional failure. In the case of network disconnection, check the patient and
solve the network problem as soon as possible.

14.2 Network Type and Settings

The equipment supports both wired and wireless network. To set the network type,
1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter the required
password→Select [Ok].
2. Select [Network Setup>>]→[Monitor Network Setup >>].

14-1
 In the Monitor Network Setup menu, you can:
 Set [Network Type] to [LAN] or [WLAN].
 Set [Address Type] to [DHCP] or [Manual].
 If [Address Type] is set to [DHCP], the monitor can automatically acquire
network parameters.
 If [Address Type] is set to [Manual], you need to manually input the monitor IP
address, subnet mask and gateway address.

14.2.1 Wireless Network

The patient monitors can be connected to a wireless network via a built-in Wi-Fi module.
To set the wireless network:
1. Select [Main]→[Maintenance>>]→[User Settings >>]→enter the required
password→Select [Ok]→[Network Setup >>]→[Monitor Network Setup >>].
2. Set the [Network Type] to [WLAN].
3. Select [WLAN Setup >>] to access the WLAN setup menu.
4. Configure the [Network Name (SSID)], [Security] and [Password].
5. Click [OK] to confirm the setting.

14.2.2 WLAN Test

To test the availability of the wireless network, follow this procedure:
1. Select [WLAN Test >>] in the [Network Setup] menu.
2. Enter the [IP Address] of wireless AP in the [WLAN Test >>] menu.
3. Click [Connection Test].

The Wi-Fi device used in the monitor is in compliance with IEEE 802.11a/b/g/n.

You should not change the patient monitor’s IP address randomly. If you want to know
details about IP address setup, contact the technical personnel in charge of the CMS.

NOTE
 The design, installation, restruction and maintenance of the wireless network’s
distribution shall be performed by authorized service personnel of our
company.
 The existence of obstacles (such as wall) will exert impact on data transferring
or even cause network interruption.
 An access point (AP) supports a maximum of 16 monitors through wireless
network.
 Keep network authentication information (e.g, password) safe to protect the

14-2
 network from being accessed by unauthorized users.
 The total throughput of all the wireless devices connected to the wireless
network should be less than the effective transmitting capability of the wireless
network. The throughput capacity of a single VS-900 is 700 kbps.
 Do not connect non-approved devices to the wireless network.
 Where the monitor is located, the signal strength of other Wi-Fi devices on the
same channel should be no greater than -85 dBm.
 Where the monitor is located, the signal strength of other Wi-Fi devices on
adjacent channels should be no greater than -50 dBm.
 The recommended distance between the patient monitor and other non-Wi-Fi
wireless devices, including wireless devices at the frequency of 2.4GHz (e.g.
cellular mobile communication networks, microwave ovens, interphones,
cordless phones and electro-surgical units) is no less than 20 cm.

14.3 Setting Data Send Method

You can choose to send the monitor data to hospital system through eGateway or HL7
protocol.
1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter the required
password→Select [Ok]→[Network>>].
2. Set [Data Send Method] to [eGateway Send] or [HL7 Direct Send].

14.3.1 ADT Communication Setup

1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter the required
password→Select [Ok]→[Network >>]→[ADT Communication>>].
2. Set IP address and port, and switch on/off ADT query.
3. Select [Ok] to exit the menu.

14.3.2 EMR Communication Setup

1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter the required
password→Select [Ok]→[Network>>]→[EMR Communication >>].
2. Set the IP address and port.
3. Select [Ok] to exit the menu.

14.3.3 NTP Server Setup

1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter the required
password→Select [Ok] to access User Settings menu.

14-3
 2. Select [Network>>]→[NTP Setup>>].
3. Select [NTP Setup>>] to enter the NTP Setup menu. Set the following properties:
 Set IP address and port.
 Set the interval.
 Set the time zone.
 Switch on/off the daylight saving time.
4. Select [Ok] to exit the menu.

To manually start one time synchronization with the NTP server, follow this procedure:
1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter the required
password→Select [Ok] to access User Settings menu.
2. Select [Network>>]→[NTP Setup>>]→[Manual].

14.3.4 Realtime Date Send Interval (for HL7 only)

The monitor will send out the monitored parameter data at the set intervals.
1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter the required
password→Select [Ok] to access User Settings Menu.
2. Select [Network>>]→[EMR Communication>>].
3. Set [Real Data Send] to an appropriate setting.

14.3.5 Alarm Server Setup (for HL7 only)

1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter the required
password→Select [Ok] to access User Settings menu.
2. Select [Network>>]→[Alarm Server Setup].
3. Set the IP address and port.
4. Select [Ok] to exit the menu.

14.4 Connecting the monitor to the CMS

To connect the monitor to the CMS, proceed as follows:
1 Select [Main]→[Maintenance >>]→[User Settings >>]→enter the required
password→Select [Ok]→[Network >>]→[Monitor Network Setup >>].
2. Set [Network Type] and [Address Type].
3. Input the monitor IP address, subnet mask and gateway address if the [Address Type]
is set to [Manual]
4. Connect the monitor to the CMS through either of the following methods:

14-4
  Admit the monitor on the CMS. Refer to the Hypervisor VI Operator’s Manual
(PN: 300B-20-47610) for details of admitting a monitor.
 Setting the CMS (refer to section 14.4.1 Setting the CMS for details), and then
selecting a CMS (refer to section 14.4.2 Selecting a CMS for details).

14.4.1 Setting the CMS

You can configure up to 30 central stations (CMS) for your monitor. To set the CMSs,
1 Select [Main]→[Maintenance>>]→[User Settings >>]→enter the required
password→Select [Ok]→[Network>>].
2. Set [Select CMS] to [On].
3. Select [Central Station Setup >>].
4. Set CMS names and corresponding IP addresses.

14.4.2 Selecting a CMS

If [Select CMS] is enabled, you can select the CMS for the current monitoring.

To select the CMS, select the prompt message area at the bottom of the screen. Then the
selected CMS name will display.

If the CMS you select does not have a name, this area displays ‘‘???’’.

14.4.3 Clearing the Selected CMS at Startup

You can clear the selected CMS each time the monitor restarts after being powered off for
more than 2 minutes.

To clear the selected CMS,

1 Select [Main]→[Maintenance>>]→[User Settings >>]→enter the required
password→Select [Ok]→[Network>>].
2. Set [Clear CMS IP at startup] to [On]

The selected CMS will not be cleared when only one CMS is configured, or the monitor is
restarted within 2 minutes.

This function is switched off by default.

14.5 Certificates Maintenance

You can import or delete the monitor’s certificates.
1. Select [Main Menu]→[Maintenance>>]→[User Maintenance>>]→enter the
required password→[Network >>]→[Certificates Maintenance >>].

14-5
 2. Select [Import certificates >>] or [Delete certificates >>].

14.6 Setting the Multicast Parameters

Whether the equipment is presented by broadcast or multicast is defined before the
equipment leaves the factory. If [Multicast] is selected, you need to set the multicast
parameters.

To do so,
1 Select [Main]→[Maintenance>>]→[User Settings >>]→enter the required
password→Select [Ok]→[Network >>]→[Multicast Setup >>].
2. Set [Multicast Addr] and [TTL].

14.7 DIAP Communication Setup

1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter the required
password→Select [Ok] to access user settings menu.
2. Select [DIAP Communication>>] to access [DIAP Communication Setup] menu.
3. Set up the baud rate.
4. Select [Ok] to exit the menu.

14-6
15 Battery

15.1 Overview
The monitor is designed to operate from battery power when AC power supply is not
available. In case of power failure, the equipment will automatically run power from
internal battery. So we recommend you always install a fully charged battery in the
equipment.

Where the integrity of the external protective conductor in the installation or its
arrangement is in doubt, the equipment shall be operated from the battery.

CAUTION
 Remove the battery before transporting the equipment or if the equipment will
not be used for a long time.

NOTE
 It is recommended to always install a fully charged battery in the monitor to
ensure normal monitoring in case of accidental power failure.

The on-screen battery symbol indicate the battery status as follows:

 Indicates that battery works correctly. The solid portion represents the
current charge level of the battery in proportion to its maximum charge level.

 Indicates that the battery has low charge level and needs to be charged.

 Indicates that the battery is almost depleted and need to be charged

immediately. Otherwise, the monitor will shut down automatically.

 Indicates that no battery is installed.

The capacity of the battery is limited. When the battery is low, the technical alarm area
displays [Low Battery], the alarm lamp flashes, and monitor produces alarm sound.

If the battery is deplete, the battery symbol on the screen starts to flash, the technical
alarm area displays [Battery Depleted], the alarm lamp flashes, and monitor produces
alarm sound. At this moment, connect the equipment to AC mains to run the equipment
and charge the battery. Otherwise the equipment will shut down.

15-1
15.2 Charging a Battery
The battery is charged whenever the monitor is connected to an AC power source
regardless of whether or not the monitor is currently on. When battery is charging, the AC
power indicator and battery indicator are both On. The battery status symbol on the
monitor screen displays when the charging is complete.

15.3 Replacing a Battery

1. Power off the monitor.
2. Open the battery compartment door.
3. Push aside the latch fixing the battery to be replaced and remove the battery.
4. Place a new battery into the slot with its contact point inward.
5. Close the battery compartment door.

15.4 Battery Guidelines

Life expectancy of a battery depends on how frequent and how long it is used. For a
properly maintained and stored lithium ion battery, its life expectancy is about 3 years.
For more aggressive use models, life expectancy can be less. We recommend replacing
lithium ion batteries every 3 years.

To get the most out of the battery, observe the following guidelines:
 The battery performance test must be performed once a year, before monitor
repairs, or whenever the battery is suspected as being the source of the
problems.
 Condition the batteries once when they are used or stored for three months, or
when their run time becomes noticeably shorter.
 Take out the battery before the monitor is transported or will not be used for
more than 3 months.
 Remove the battery from the monitor if it is not being used regularly. (Leaving
the battery in a monitor that is not in regular use will shorten the life of the
battery).
 The shelf life of a Lithium Ion battery is about 6 months when the battery is
stored with the battery power being 50% of the total power. In 6 months the
battery power must be depleted before the Lithium Ion battery is fully charged.
Then run the monitor on this fully charged battery .When its battery power
becomes 50% of the total power, take out the battery from the monitor and
store it.
 When storing batteries, make sure that the battery terminals do not come into
contact with metallic objects. If batteries are stored for an extended period of
time, they should be placed in a cool place with a partial charge of 40% to 60%
capacity. Storing batteries at high temperature for an extended period of time

15-2
 will significantly shorten the life expectancy of a battery. Do not store the
battery at a temperature beyond -20°C- 60°C.

WARNING
 Keep the battery out of children’s reach.
 Use only specified batteries.
 If the battery shows signs of damage or signs of leakage, replace it immediately.
Do not use a faulty battery in the monitor.

15.5 Battery Maintenance

15.5.1 Conditioning a Battery
A battery should be conditioned before it is used for the first time. A battery conditioning
cycle is one uninterrupted charge of the battery, followed by an uninterrupted battery
discharge and charge. Batteries should be conditioned regularly to maintain their useful
life.

To condition a battery, follow this procedure:

1. Disconnect the monitor from the patient and stop all monitoring or measuring.
2. Insert the battery in need of conditioning into the battery slot of the monitor.
3. Connect the monitor to AC power. Allow the battery to be charged uninterrupted till
the battery is full and the battery indicator is off.
4. Remove AC power and allow the monitor to run from the battery until it shuts off.
5. Again connect the monitor to AC power. Allow the battery to be charged
uninterruptedly till the battery is full and the battery indicator is off.

NOTE
 The actual battery capacity will decrease over time with use of batteries. For old
batteries, the full capacity battery symbol does not indicate the capacity and
operating time of this battery can still fulfill battery specifications in the
operator’s manual. Please replace the battery if its operating time is
significantly lower than the specified time.

15.5.2 Checking a Battery

The performance of a rechargeable battery may deteriorate over time. The battery
performance test must be performed once a year, before monitor repairs, or whenever the
battery is suspected as being the source of the problems.

To check the performance of a battery, follow this procedure:

1. Disconnect the monitor from the patient and stop all monitoring or measuring.

15-3
 2. Install the battery.
3. Connect the monitor to AC power. Allow the battery to be charged uninterrupted till
the battery is full and the battery indicator is off.
4. Remove AC power and allow the monitor to run from the battery until it shuts off.

The operating time of a battery reflects their performance directly. If the operating time of
a battery is noticeably shorter than that stated in the specifications, contact your service
personnel.

NOTE
 The battery might be damaged or malfunctioned if its operating time is too
short after being fully charged. The operating time depends on the
configuration and operation. For example, measuring NIBP more frequently will
also shorten the operating time.
 When a battery has visual signs of damage, or no longer holds a charge, it
should be replaced. Remove the old battery from the monitor and recycle it
properly.

15.6 Recycling a Battery

When a battery has visual signs of damage, or no longer holds a charge, it should be
replaced. Remove the old battery from the monitor and recycle it properly. To dispose of
the batteries, follow local laws for proper disposal.

WARNING
 Do not disassemble batteries, or dispose of them in fire, or cause them to short
circuit. They may ignite, explode, leak or heat up, causing personal injury.

15-4
16 Care and Maintenance

The monitor should be maintained and cleaned on a regular basis. This chapter describes
the basic cleaning, disinfection and test method.

WARNING
 Failure of the responsible individual, hospital or institution employing this
equipment to implement a satisfactory maintenance schedule may cause
undue equipment failure and possible health hazards.
 The safety checks or maintenance involving any disassembly of the equipment
should be performed by professional servicing personnel. Otherwise, undue
equipment failure and possible health hazards could result.
 If you discover a problem with any of the equipment, contact your service
personnel or us.
 The responsible hospital or institution shall carry out all cleaning and
disinfection procedure specified in this chapter.
 Do not open the equipment housings. All servicing and future upgrades must
be carried out by the personnel trained and authorized by our company only.
 No modification of this equipment is allowed.
 The service personnel must be properly qualified and thoroughly familiar with
the operation of the equipment.

16.1 Cleaning and Disinfection

In this chapter we only describe cleaning and disinfection of the main unit. For the
cleaning and disinfection of other reusable accessories, refer to instructions for use of
corresponding accessories.

Keep you equipment and accessories clean. To avoid damage to the equipment, follow
these rules:
 Always dilute according the manufacturer’s instructions or use lowest possible
concentration.
 Do not immerse part of the equipment into liquid.
 Do not pour liquid onto the equipment or accessories.
 Do not allow liquid to enter the case.
 Never use abrasive materials (such as steel wool or silver polish), or erosive
cleaners (such as acetone or acetone-based cleaners).

16-1
 WARNING
 Be sure to shut down the system and disconnect all power cables from the
outlets before cleaning the equipment.
 Use only the substances approved by us and methods listed in this chapter to
clean or disinfect your equipment. Warranty does not cover damage caused by
unapproved substances or methods.
 We make no claims regarding the efficacy of the listed chemicals or methods as
a means for controlling infection. For the method to control infection, consult
your hospital’s Infection Control Officer or Epidemiologist.

CAUTION
 If you spill liquid on the equipment or accessories, contact us or your service
personnel.

16.1.1 Cleaning
Your equipment should be cleaned on a regular basis. If there is heavy pollution or lots of
dust and sand in your place, the equipment should be cleaned more frequently. Before
cleaning the equipment, consult your hospital’s regulations for cleaning the equipment.

Recommended cleaning agents are:

 sodium hypochlorite bleach (diluted)
 Hydrogen peroxide (3%)
 Ethanol (70%)
 Isopropanol (70%)

To clean your equipment, follow these rules:

1. Shut down the monitor and disconnect it from the power line.
2. Clean the display screen using a soft, clean cloth dampened with a glass cleaner.
3. Clean the exterior surface of the equipment using a soft cloth dampened with the
cleaner.
4. Wipe off all the cleaning solution with a dry cloth after cleaning if necessary.
5. Dry your equipment in a ventilated, cool place.

16-2
16.1.2 Disinfecting
Disinfection may cause damage to the equipment and is therefore not recommended for
this monitor unless otherwise indicated in your hospital’s servicing schedule. Cleaning
equipment before disinfecting is recommended.

The recommended disinfectants include: ethanol 70%, isopropanol 70%, Perform® classic
concentrate OXY.

16.2 General Inspection

Before every first use, after your equipment has been used for 6 to 12 months, or
whenever your equipment is repaired or upgraded, a thorough inspection should be
performed by qualified service personnel to ensure the reliability.

Follow these guidelines when inspecting the equipment:

 Make sure that the environment and power supply meet the requirements.
 Inspect the equipment and its accessories for mechanical damage.
 Inspect all power cords for damage, and make sure that their insulation is in
good condition.
 Make sure that only specified accessories are applied.
 Inspect if the alarm system functions correctly.
 Make sure that the recorder functions correctly and the recorder paper meets
the requirements.
 Make sure that the battery meets the performance requirements.
 Make sure that the monitor is in good working condition.

In case of any damage or abnormity, do not use the equipment. Contact the hospital’s
biomedical engineers or your service personnel immediately.

16.3 Maintenance and Testing Schedule

The following maintenance and tests, except for visual inspection, power on test,
touchscreen calibration, and battery check, shall be carried out by the service personnel
only. Contact your service personnel if any maintenance is required. Make sure to clean
and disinfect the equipment before any test and maintenance.

CAUTION
 Care should be taken to change the settings in [User Settings >>] and [Factory
Maintenance >>] menus to avoid data loss.
 Service personnel should acquaint themselves with the test tools and make
sure that test tools and cables are applicable.

16-3
Check/Maintenance Item Recommended Frequency
Preventive Maintenance
Visual inspection When first installed or after reinstalled.
Pressure check
NIBP Tests 1. If the user suspects that the measurement is
Leakage Test incorrect.
Leakage test 2. Following any repairs or replacement of the
module.
CO2 Test Performance test
3. At least once a year
Calibration
Performance Test
SpO2 Test
Pressure check 1. If the user suspects that the measurement is
NIBP test
Leakage test incorrect.
2. Following any repairs or replacement of the
Temp test
module.
Leakage test 3. At least once every two years for SpO2 and
CO2 test and Temp, and at least once a year for NIBP and CO2.
Performance test
calibration
Calibration
If user suspects that the nurse call or analog output
Nurse Call Relay Performance Test
does not work well.
Electrical safety tests

Electrical safety tests At least once every two years, or as required.

Other tests
1. When first installed or after reinstalled.
Power on test 2. Following any maintenance or the replacement
of any main unit parts.
1. When the touchscreen appears abnormal.
Touchscreen Calibration
2. After the touchscreen is replaced.
Recorder check Following any repair or replacement of the recorder.
1. When first installed.
Functionality test
Battery 2. Whenever a battery is replaced.
check Once a year or if the battery run time reduced
Performance test
significantly.

16-4
16.4 Checking Monitor Information
Select [Main]→[Maintenance >>]→[Monitor Information>>], you can view
 system software version
 copyright information
 system configuration by selecting [Monitor Configuration>>], or;
 status information, such as start time, self-test error, and so on by selecting
[Monitor Log>>]

You can print out the log information for the convenience of troubleshooting. Select
[Recorder] from the [Monitor Log] menu to do recording. The information will not be
saved after system shutdown.

16-5
16.5 NIBP Test
16.5.1 NIBP Leakage Test
The NIBP leakage test checks the integrity of the system and of the valve. It is required at
least once a year or when you doubt the measured NIBP. If the test failed, corresponding
prompt messages will be given. If no message is displayed, it means no leakage is
detected.

Tools required:
 An adult cuff
 An air tubing
 A correct sized cylinder

Follow this procedure to perform the leakage test:

1. In the [Patient Demographics] menu, set [Patient Category] to [Adult].
2. Connect the cuff to the NIBP cuff connector on the monitor.
3. Wrap the cuff around the cylinder as shown below.

Monitor Cylinder

Connector for Air Tubing Cuff

NIBP cuff

4. Select [Main]→[Maintenance >>]→[User Settings>>]→Enter required

password→→[Module Maintenance >>]→[NIBP Leakage Test]. The message
[Leakage Testing…] is displayed in the NIBP parameter area.

After about 20 seconds, the monitor will automatically deflate. This means the test is
completed. If the message [NIBP Pneumatic Leak] is displayed, it indicates that the NIBP
airway may have leakages. Check the tubing and connections for leakages. If you ensure
that the tubing and connections are all correct, perform a leakage test again. If the
problem persists, contact your service personnel.

NOTE

 The leakage test is intended for use to simply determine whether there are
leakages in the NIBP airway.

16-6
16.5.2 NIBP Accuracy Test
The NIBP accuracy test is required at least once a year or when you doubt the measured
NIBP.

Tools required:
 T-shape connector
 Tubing
 Balloon pump
 Metal Vessel (volume 500±25 ml)
 Reference manometer (calibrated with accuracy equal to or better than 0.75
mmHg)

Follow this procedure to perform the accuracy test:

1. Connect the equipment as shown.

Monitor

Manometer

Connector for Tubing

NIBP cuff

Balloon pump Metal vessel

2. Before inflation, check that the reading of the manometer should be 0. If not, open
the valve of the balloon pump to let the whole airway open to the atmosphere. Close
the valve of the balloon pump after the reading is 0.
3. Select [Main]→[Maintenance >>]→[User Settings>>]→Enter required password→
→[Module Maintenance >>]→[NIBP Accuracy Test]. The message [Accuracy
Testing…] is displayed in the NIBP parameter area.
4. Check the manometer values and the monitor reading. Both should be 0mmHg.
5. Raise the pressure in the metal vessel to 50 mmHg with the balloon pump. Then wait
for 10 seconds until the measured values become stable.
6. Compare the manometer values with the displayed values. The difference between
the manometer and displayed values should be within ± 3 mmHg.
7. Raise the pressure in the metal vessel to 200 mmHg with the balloon pump. Then
wait for 10 seconds until the measured values become stable. Repeat step 6.

16-7
 If the difference between the manometer and displayed values is greater than 3 mmHg,
contact your service personnel.

16.6 CO2 Test

16.6.1 CO2 Leakage Test

For low flow rate CO2 module, leakage test is needed every year or when you suspect the
measurement.

Follow this procedure to perform the test:

1. Wait until CO2 warmup is finished and then use your hand or other objects to
completely block the gas inlet of the mini water trap.
The alarm message [CO2 FilterLine Occluded] is displayed on the screen after
certain time.
2. Block the gas inlet for another 30 seconds.
If the alarm message does not disappear, it indicates that the module does not leak.

16.6.2 CO2 Accuracy Test

For the CO2 module, accuracy test is needed every year or when you suspect the
measurement.

Tools required:
 A steel gas cylinder with 5±0.03% CO2 and balance gas N2 (P/N 0075-00-0033-01)
 T-shape connector
 Tubing

Follow this procedure to perform the test:

1. Wait until the CO2 module warmup is finished, and check the airway for leakage and
perform a leakage test as well to make sure the airway has no leakage.
2. Select [Main]→[Maintenance >>]→[User Settings >>]→enter the required
password→[Module Maintenance >>]→[Calibrate CO2>>]→[Calibrate].
3. Connect the test system as follows:

16-8
 Open to the air

Tubing
Relief valve

T-shape connector Monitor

Gas cylinder

5. Open the relief valve to vent standard CO2 and make sure that there is an excess gas
flow through the T-shape connector to air.
6. Check the realtime CO2 value is within 5.0±0.3% in the [Calibrate CO2] menu.

16.6.3 Calibrating CO2

For the CO2 module, a calibration is needed every year or when the measured values have
a great deviation. Calibration for the CO2 module can be performed only when the
module enters the full accuracy mode.

WARNING
 Connect an exhaust tube to the gas outlet connector of the monitor to remove
the calibration gases to a scavenging system.

Tools required:
 A steel gas cylinder with 5±0.03% CO2 and balance gas N2 (P/N 0075-00-0033-01)
 T-shape connector
 Tubing

Follow this procedure to perform a calibration:

1. Make sure that the CO2 module has been warned up or started up.
2. Check the airway for leakage and perform a leakage test as well to make sure the
airway has no leakage.
3. Select [Main]→ [Maintenance >>]→ [User Settings >>]→ enter the required
password→[Module Maintenance >>]→ [Calibrate CO2 >>]→ [Zero].
4. After the zero calibration is finished successfully, connect the equipment as follows:

16-9
 Flowmeter

Tubing
Relief valve
T-shape connector Monitor

Gas cylinder

5. Turn on and adjust the relief valve to make the flowmeter reads within 10-50ml/min
and keeps stable as well.
6. In the [Calibrate CO2] menu, enter the vented CO2 concentration in the [CO2] field.
7. In the [Calibrate CO2] menu, the measured CO2 concentration is displayed. After the
measured CO2 concentration becomes stable, select [Calibrate] to calibrate the CO2
module.
If the calibration is finished successfully, the message [Calibration Completed!] is
displayed in the [Calibrate CO2] menu. If the calibration failed, the message [Calibration
Failed!] is displayed. In this case, perform another calibration.

16.7 Calibrating the Touchscreen

1. Select [Main]→[Maintenance>>]→[Calibrate Touchscreen]. The symbol will
appear at different positions of the screen.

2. Select, in turn the central point of the symbol. After the calibration is
completed, the message [Screen Calibration Completed！] is displayed.
3. Select [Ok] to confirm the completion of the calibration.

16.8 Formatting the Storage Card

The monitor is configured with an SD card for saving data. To format the storage card:
1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter the required
password→Select [Ok] to access the [User Settings] menu.
2. Select [Format Storage Card], and then select [Ok] in the pop-up dialog.

16.9 Modifying Password

1. Select [Main]→[Maintenance >>]→[User Settings >>]→Enter the required
password→Select [Ok] to access the [User Settings] menu.

16-10
2. Select [Modify Password>>].
3. Enter new password and then select [Ok].

16-11
FOR YOUR NOTES

16-12
17 Accessories

WARNING
 Use accessories specified in this chapter. Using other accessories may cause
damage to the equipment or not meet the claimed specifications.
 Single-use accessories are not designed to be reused. Reuse may cause a risk of
contamination and affect the measurement accuracy.
 Check the accessories and their packages for any sign of damage. Do not use
them if any damage is detected.
 The disposable accessories shall be disposed of according to hospital’s
regulations.
 The accessory material that contacts the patients or other staff has undertaken
the bio-compatibility test and is verified to be in compliance with ISO 10993-1.
 Use the accessories before the expiry date if their expiry date is indicated.
 For details about the accessories, refer to the instructions for use provided with
the accessory.

17.1 SpO2 Accessories

Extension Cable
Module type Remarks Part No.
7 pins, 2.5 m 0010-20-42710
Mindray SpO2 Module
7 pins, 1.2 m 040-001443-00
Masimo SpO2 Module 8 pins, 2.1 m 040-000332-00
Nellcor SpO2 Module 8 pins, 2.5 m 0010-20-42712

SpO2 Sensors
Mindray SpO2 module
Type Model Patient Category Part No.
MAX-AI Adult (>30Kg) 0010-10-12202
MAX-PI Pediatric (10 to 50Kg) 0010-10-12203
Disposable MAX-II Infant (3 to 20Kg) 0010-10-12204
Neonate (<3Kg), Adult
MAX-NI 0010-10-12205
(>40Kg))

17-1
Mindray SpO2 module
Type Model Patient Category Part No.
520A Adult (non-adhesive) 520A-30-64101
520P Pediatric (non-adhesive) 520P-30-64201
520I Infant (non-adhesive) 520I-30-64301
520N Neonate (non-adhesive) 520N-30-64401
DS-100A Adult (Finger) 9000-10-05161
OXI-P/I Pediatric, infant 9000-10-07308
OXI-A/N Adult, neonate 9000-10-07336
ES-3212-9 Adult, Neonate (Ear) 0010-10-12392
518B Neonate (Foot) 518B-30-72107
Reusable 518C Neonate (Foot) 040-000330-00
512E Adult (Finger) 512E-30-90390
512F Adult (Finger, split) 512F-30-28263
512F Adult (Finger, integrated) 115-012807-00
512G 512G-30-90607
Pediatric (Finger)
512H 512H-30-79061

Masimo SpO2 module

Type Model Patient Category Part No.
LNCS NeoPt-L Pediatric, neonate 0010-10-42626
LNCS Neo-L Neonate 0010-10-42627
LNCS Pdtx Pediatric 0010-10-42629
LNCS Adtx Adult 0010-10-42630
Disposable
LNCS NeoPt Neonate (<1 kg) 040-000295-00
LNCS Neo Adult and pediatric (>40 Kg),
040-000296-00
neonate(<3 Kg)
LNCS Inf Pediatric and neonate (3 to 20
040-000297-00
Kg)
LNCS DCI Adult (Finger) 0010-10-42600
LNCS DCIP Pediatric (Finger) 0010-10-42634
Reusable
Adult, pediatric, neonate
LNCS YI 0010-10-43016
(Finger)

17-2
Nellcor SpO2 Module
Type Model Patient Category Part No.
MAX-AI Adult (>30Kg) 0010-10-12202
MAX-PI Pediatric (10 to 50Kg) 0010-10-12203
Disposable
MAX-II Infant (3 to 20Kg) 0010-10-12204
MAX-NI Neonate (<3Kg), Adult (>40Kg) 0010-10-12205
DS-100A Adult 9000-10-05161
OXI-P/I Pediatric, infant 9000-10-07308
Reusable
OXI-A/N Adult, neonate 9000-10-07336
D-YS Adult, Pediatric, infant, neonate 0010-10-12476

Wavelength emited by the sensors is between 600 nm and 1000 nm.

The maximum photic output consumption of the sensor is less than 18 mW.

The information about the wavelength range and maximum photic output consumption
can be especially useful to clinicians (for example, when photodynamic therapy is
performed).

17.2 NIBP Accessories

Tubing
Type Patient Category Part No.
Adult, pediatric, infant 6200-30-09688
Reusable
Neonate 6200-30-11560

Reusable Cuff
Patient Measurement Limb
Model Part No.
Category Site Circumference (cm)
CM1200 Small Infant 7 to 13 115-002480-00
CM1201 Infant 10 to 19 0010-30-12157
CM1202 Pediatric Arm 18 to 26 0010-30-12158
CM1203 Adult 24 to 35 0010-30-12159
CM1204 Large adult 33 to 47 0010-30-12160
CM1205 Adult Thigh 44 to 66 0010-30-12161
CM1300 Small infant Arm 7 to 13 040-000968-00

17-3
 Patient Measurement Limb
Model Part No.
Category Site Circumference (cm)
CM1301 Infant 10 to 19 040-000973-00
CM1302 Pediatric 18 to 26 040-000978-00
CM1303 Adult 24 to 35 040-000983-00
CM1304 Large adult 33 to 47 040-000988-00
CM1305 Adult Thigh 46 to 66 040-000993-00

Disposable Cuff
Patient Measurement Limb
Model Part No.
Category Site Circumference (cm)
CM1500A 3.1 to 5.7 001B-30-70692
CM1500B 4.3 to 8.0 001B-30-70693
CM1500C Neonate 5.8 to 10.9 001B-30-70694
CM1500D 7.1 to 13.1 001B-30-70695
CM1500E Arm 8 to 15 001B-30-70681
CM1501 Infant 10 to 19 001B-30-70697
CM1502 Pediatric 18 to 26 001B-30-70698
CM1503 Adult 24 to 35 001B-30-70699
CM1504 Large adult 33 to 47 001B-30-70700
CM1505 Adult Thigh 46 to 66 001B-30-70701

17.3 Temp Accessories

17.3.1 SmarTemp™ Accessories
Probe Well
Type Description Part No.
Blue, oral /axillary M09A-20-62062
Reusable
Red, Rectal M09A-20-62062-51

Temp Probes
Type Patient Category Measurement Site Part No.
Adult, Pediatric, Neonate Oral/ Axillary 6006-30-39598
Reusable
Adult, Pediatric Rectal 6006-30-39599

17-4
Probe Cover
Type Patient Category Description Part No.
Adult, Pediatric, Neonate Cover, 20 pcs/pack M09A-20-62124
Disposable Adult, Pediatric, Neonate Cover, 200 pcs/pack M09A-30-62126
Adult, Pediatric, Neonate Cover, 2000 pcs/pack M09A-30-62128

17.3.2 THP79JU Ear Thermometer Accessories

Ear Thermometer
Type Description Part No.
Reusable Infrared ear thermometer 100-000102-00

Probe Cover
Type Patient Category Description Part No.
Disposable Adult, Pediatric, Neonate Cover, 200 pcs/pack 100-000103-00

17.3.3 GeniusTM 2 Tympanic Thermometer Accessories

Tympanic Thermometer
Type Description Part No.
Reusable Tethered tympanic thermometer 100-000198-00

Probe Cover
Type Patient Category Description Part No.
Disposable Adult, Pediatric, Neonate Cover, 96 pcs/case 100-000200-00

17.4 CO2 Accessories

Water Trap
Type Description Part No.
Disposable DRYLINETM PRIME Watertrap mini 100-000151-00

17-5
Sampling Line
Patient
Type Model Description Part No.
Category
Gas sampling line with Adult,
100-000138-00
airway adapter Pediatric
Gas sampling line with Neonate
100-000139-00
DRYLINETM airway adapter
PRIME
Nasal gas sampling line Adult 100-000142-00
Nasal gas sampling line Pediatric 100-000143-00
Nasal gas sampling line Neonate 100-000144-00
Disposable
Gas sampling line with Adult,
100-000140-00
airway adapter Pediatric
Gas sampling line with Neonate
100-000141-00
DRYLINETM airway adapter
PRIME+
Nasal gas sampling line Adult 100-000145-00
Nasal gas sampling line Pediatric 100-000146-00
Nasal gas sampling line Neonate 100-000147-00

17-6
A Product Specifications

A.1 Classifications
The equipment is classified, according to IEC60601-1:
Type of protection against electrical CLASS I EQUIPMENT, equipment energized from an
shock external and internal electrical power source.
DEFIBRILLATION-PROOF TYPE CF AAPPLIED PART for
Degree of protection against electrical SpO2, NIBP, and TEMP
shock DEFIBRILLATION-PROOF TYPE BF AAPPLIED PART for
CO2
Mode of operation Continuous
Degree of protection against harmful
IPX1(Protection against vertically falling water drops)
ingress of water
degree of safety of application in the
presence of a FLAMMABLE EQUIPMENT not suitable for use in the presence of a
FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or
ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE
WITH OXYGEN OR NITROUS OXIDE
Degree of mobility Portable

A.2 Environmental Specifications

Main Unit
Item Operating conditions Storage conditions
Temperature 0 to 40 ºC -20 to 60 ºC
Relative humidity
15% to 95% 10% to 95%
(non-condensing)
Barometric 57.0 to 107.4 kPa 16.0 to 107.4 kPa

SmarTempTM Temperature Module

Item Operating conditions Storage conditions

Temperature 5 ºC to 40 ºC -20 ºC to 60 ºC
Relative humidity
15% to 95% 10% to 95%
(non-condensing)
Barometric 57.0 kPa to 107.4 kPa 16.0 kPa to 107.4 kPa

GeniusTM 2 Temperature Module

A-1
Item Operating conditions Storage conditions
Temperature 16ºC to 33 ºC (60.8ºF to 91.4 ºF) -25 to 55ºC (-13ºF to 131ºF)
Relative humidity
10% to 95% up to 95%
(non-condensing)

WARNING
 The equipment may not meet the performance specifications if stored or used
outside the specified temperature and humidity ranges.

NOTE

 The environmental specifications of unspecified parameters are the same as

those of the main unit.

A.3 Power Supply Specifications

AC Power
Line voltage 100 to 240 VAC ~ (±10%)
Current 0.9 to 0.5A
Frequency 50/60 Hz (±3Hz)
Fuse T2AL-250V

Battery
Battery (Standard)
Battery Type LI13I001A, Chargeable Lithium-Ion
Voltage 11.1 VDC
Capacity 2600 mAh
At least 3 hours when powered by a new fully-charged
Run time battery at 25°C ±5°C with SpO2 cable connected, and auto
NIBP measurements at an interval of 15 minutes.
Monitor power off: less than 3 hours to 90%; less than 4 hours
to 100%.
Charge time
Monitor power on: less than 6 hours to 90%; less than 7.5
hours to 100%.

A-2
Shutdown delay At least 20 minutes (after a low battery alarm first occurs)
Battery (Optional)
Battery Type LI23S002A, Chargeable Lithium-Ion
Voltage 11.1 VDC
Capacity 4500 mAh
At least 8 hours when powered by a new fully-charged
Run time battery at 25°C±5°C with SpO2 cable connected, and auto
NIBP measurements at an interval of 15 minutes.
Monitor power off: less than 5.5 hours to 90%; less than 6.5
hours to 100%.
Charge time
Monitor power on: less than 10.5 hours to 90%; less than 11.5
hours to 100%.
Shutdown delay At least 20 minutes (after a low battery alarm first occurs)

A.4 Physical Specifications

Size 178mm×150mm×260mm
Weight ≤2.5 kg (with SpO2 module, NIBP module, recorder module and
a battery)

A.5 Hardware Specifications

A.5.1 Display
Screen type Color TFT LCD
Screen Size (diagonal) 8.4’’
Resolution 800×600 pixels

A.5.2 Recorder
Method Thermal dot array
Paper speed 25 mm/s
Number of waveform
1
channels

A.5.3 LEDs
Alarm lamp 1 (two color coded: yellow and red)
Power on LED 1 (green)

A-3
AC power LED 1 (green)
Battery LED 1 (green)

A.5.4 Audio Indicator

Give alarm tones (45 to 85 dB), key tones, pulse tone; power-on
Speaker self-check tone, support PITCH TONE and multi-level tone
modulation; alarm tones comply with IEC 60601-1-8.

A.5.5 Monitor Interface Specifications

Power 1 AC power input connector
Wired network 1 RJ45 connector
USB 2 standard connectors, USB 2.0
Equipotential Grounding
1
Terminal
Multi-Functions Connector 1 MINI-D RIBBON connector

A.5.6 Outputs
Nurse Call Signal
High level: >3V, providing a maximum of 3 mA output current
Amplitude
Low level: <0.5 V, receiving a maximum of 5 mA input current
Rising and falling time ≤ 1 ms
Alarm output (Network connector)
Alarm delay time from The alarm delay time form the monitor to remote equipment is
monitor to remote ≤2 seconds, measured at the monitor’s signal output
equipment connector.

A.5.7 Data Storage

Trends 5000 groups

A.5.8 Wireless Network

Standards MSD45N Wireless Module: IEEE 802.11a/b/g/n, support Wi-Fi

A.6 Measurement Specifications

A.6.1 SpO2

A-4
Alarm limit Range (%) Step (%)
SpO2 High (low limit + 2) to 100
Mindray, Masimo: Desat to (high limit --- 2)
SpO2 Low Nellcor: Desat or 20 (whichever is greater) to 1
(high limit --- 2)

Desat 0 to (high limit --- 2)

Mindray SpO2 Module

Standards Meet standards of ISO 80601-2-61
*Measurement accuracy verification: The SpO2 accuracy has been verified in human
experiments by comparing with arterial blood sample reference measured with a CO-oximeter.
Pulse oximeter measurements are statistically distributed and about two-thirds of the
measurements are expected to come within the specified accuracy range compared to
CO-oximeter measurements.
SpO2 Measurement range 0 to 100%
PI measurement range 0.05% to 20%
SpO2 Resolution 1%
70 to 100%: ±2% (measured without motion in adult/pediatric
mode)
Accuracy
70 to 100%: ±3% (measured without motion in neonate mode)
0% to 69%: Not specified.
*Studies were performed to validate the accuracy of Pulse Oximeter with neonatal SpO2
sensors by contrast with a CO-Oximeter. Some neonates aged from 1 day to 30 days with a
gestation age of 22 weeks to full term were involved in this study. The statistical analysis of
data of this study shows the accuracy (Arms) is within the stated accuracy specification. Please
see the following table.
Sensor type Totally neonates Data Arms
518B 97 (51 male & 46 female) 200 pairs 2.38%
520N 122 (65 male & 57 female) 200 pairs 2.88%
The Pulse Oximeter with neonatal SpO2 sensors was also validated on adult subjects.
Refreshing rate 1s
≤ 30 s (PI > 0.3, no disturbance, SpO2 value sudden change
Response time
within 70% - 100%)

Masimo SpO2 Module

Standards Meet standards of ISO 80601-2-61
SpO2 Measurement range 1 to 100%

A-5
PI measurement range 0.02% to 20%
SpO2 Resolution 1%
70 to 100%: ±2% (measured without motion in adult/pediatric
mode)
Accuracy1 70 to 100%: ±3% (measured without motion in neonate mode)
70 to 100%: ±3% (measured with motion)
1% to 69%: Not specified.
Refreshing rate 1s
≤ 20 s (PR 75 bpm, average time 8 s, SpO2 value rises from 60%
Response time
to 95%)
SpO2 averaging time 2-4 s, 4-6 s, 8 s, 10 s, 12 s, 14 s, 16 s
Pulse amplitude: >0.02%
Low perfusion conditions
Light penetration: >5%
Low perfusion SpO2
±2%
accuracy2
1
The Masimo pulse oximeter with sensors have been validated for no motion accuracy in
human blood studies on healthy adult volunteers in induced hypoxia studies in the range of
70% to 100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals
plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68%
of the population. One percent was added to the accuracies for neonatal sensors to account
for accuracy variation due to properties of fetal hemoglobin.
The Masimo pulse oximeter with sensors has been validated for motion accuracy in human
blood studies on healthy adult volunteers in induced hypoxia studies while performing
rubbing and tapping motions at 2 to 4 Hz. At an amplitude of 1 to 2 cm and non-repetitive
motion between 1 to 5 Hz. At an amplitude of 2 to 3 cm in induced hypoxia studies in the
range of 70% to 100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation
equals plus or minus one standard deviation. Plus or minus one standard deviation
encompasses 68% of the population.
2
The Masimo pulse oximeter has been validated for low perfusion accuracy in bench top
testing against a Biotek Index 2 simulator and Masimo’s simulator with signal strengths of
greater than 0.02% and a % transmission of greater than 5% for saturations ranging from 70 to
100%. This variation equals plus or minus one standard deviation. Plus or minus one standard
deviation encompasses 68% of the population.

Nellcor SpO2 Module

Standards Meet standards of ISO 80601-2-61
Measurement range 0 to 100%
Resolution 1%
70 to 100%: ±2% (adult/pediatric)
Accuracy
70 to 100%: ±3% (neonate)

A-6
 0% to 69%: Not specified.
Refreshing rate 1s
≤ 30 s (PI > 0.3, no disturbance, SpO2 value sudden change
Response time
within 70% - 100%)
* When the SpO2 sensor is applied for neonatal patients as indicated, the specified accuracy
range is increased by ±1%, to compensate for the theoretical effect on oximeter
measurements of fetal hemoglobin in neonatal blood.

Information of the Test Subjects of the Clinical Study Report

Skin color Gender Number Age (years) Health

Black Male 1 28.2±9.19 Healthy
Female 1
Yellow Male 3
Female 9

A.6.2 PR
Module PR High Limit PR Low Limit Step (bpm)
Mindray SpO2 Module (low limit +2) to 254 20 to (high limit-2)
Masimo SpO2 Module (low limit +2) to 240 25 to (high limit-2)
1
Nellcor SpO2 Module (low limit +2) to 300 20 to (high limit-2)
NIBP Module (low limit +2) to 240 40 to (high limit-2)

PR from Mindray SpO2 Module

Measurement range 20 to 254 bpm
Resolution 1 bpm
≤ 30 s (PI > 0.3, no disturbance, PR value sudden change within
Response time
25 --- 250 bpm)
Accuracy ±3 bpm (without motion)
Refreshing rate 1s

PR from Masimo SpO2 Module

Measurement range 25 to 240 bpm
Resolution 1 bpm

A-7
Response time ≤ 20 s (PR value sudden change within 25 --- 240 bpm)
±3 bpm (without motion)
Accuracy
±5 bpm (with motion)
Refreshing rate 1s

PR from Nellcor SpO2 Module

Measurement range 20 to 300 bpm
Resolution 1 bpm
≤ 30 s (PI > 0.3, no disturbance, PR value sudden change within
Response time
25 --- 250 bpm)
20 to 250 bpm: ±3 bpm
Accuracy
251 to 300 bpm, not specified
Refreshing rate 1s

PR from NIBP Module

Measurement range 40 to 240 bpm
Resolution 1 bpm
Accuracy ±3bpm or ±3%, whichever is greater

A.6.3 NIBP
Standards Meet standards of IEC 80601-2-30, ISO 81060-2
Technique Oscillometry
Mode of operation Manual, Auto, STAT and Program
Auto mode repetition
1, 2, 2.5, 3, 5, 10, 15, 20, 30, 60, 90 or 120 min
intervals
STAT mode cycle time 5 min
Adult, pediatric: 180 s
Max measurement time
Neonate: 90 s
Heart rate range 40 to 240 bpm
Adult Pediatric Neonate
Measurement ranges Systolic: 40 to 270 40 to 200 40 to 135
(mmHg) Diastolic: 10 to 210 10 to 150 10 to 100
Mean: 20 to 230 20 to 165 20 to 110

A-8
 Max mean error: 5 mmHg
Accuracy
Max standard deviation: 8 mmHg
Static pressure
0mmHg to 300mmHg
measurement range
Static pressure
3 mmHg
measurement accuracy
Resolution 1mmHg
Adult: 80 to 280
Initial cuff inflation pressure
Pediatric: 80 to 210
range (mmHg)
Neonate: 60 to 140
Adult: 160
Default initial cuff inflation
Pediatric: 140
pressure (mmHg)
Neonate: 90
Adult: 297±3 mmHg
Software overpressure
Pediatric: 240±3 mmHg
protection
Neonate: 147±3 mmHg
Adult: ≤330 mmHg
Hardware overpressure
Pediatric: ≤330 mmHg
protection
Neonate: ≤165 mmHg
Alarm limit Range (mmHg) Step (mmHg)
Adult: (low limit+5) to 270
Sys High Pediatric: (low limit+5) to 200
Neonate: (low limit+5) to 135
Sys Low 40 to (high limit-5)
Adult: (low limit+5) to 230
Mean High Pediatric: (low limit+5) to 165
5
Neonate: (low limit+5) to 110
Mean Low 20 to (high limit-5)
Adult: (low limit+5) to 210
Dia High Pediatric: (low limit+5) to 150
Neonate: (low limit+5) to 100
Dia Low 10 to (high limit-5)
* Measurement accuracy verification: In adult and pediatric modes, the blood pressure
measurements measured with this device are in compliance with the American National
Standard for Electronic or Automated Sphymomanometers (ANSI/AAMI SP10) in terms of
mean error and standard deviation by comparing with intra-arterial or auscultatory
measurements (depending on the configuration) in a typical patient population. For
auscultatory reference, the 5th Korotkoff sound was used to determine the diastolic

A-9
 pressure.

In neonatal mode, the blood pressure measurements measured with this device are in
compliance with the American National Standard for Electronic or Automated
Sphymomanometers (ANSI/AAMI SP10) in terms of mean error and standard deviation by
comparing with intra-arterial measurements (depending on the configuration) in a typical
patient population.

A.6.4 Temp
SmarTemp™ Temperature Module
Standards Meets standards of ISO 80601-2-56
Technique Thermal resistance (use thermistor to measure temperature )
Adjusted mode (predictive mode)
Operating mode
Direct mode (monitor mode)
Monitor mode:25°C to 44°C (77°F to 111.2°F)
Measurement range
Predictive mode: 35°C to 43°C (95°F to 109.4°F)
25°C to 32°C (not include 32°C): ± 0.2°C
32°C to 44°C (include 32°C): ±0.1°C
Accuracy (Monitor mode) or
77°F to 89.6°F (not include 89.6°F): ± 0.4°F
89.6°F to 111.2°F (include 89.6°F): ± 0.2°F
Resolution ±0.1°C or ± 0.2°F
Minimum measurement Monitor mode: < 60 s
time for accurate readings Predictive mode: < 20 s (typical test: < 12s )
Alarm limit Range Step
(low limit +1)°C to 44°C
Temp High
(low limit +1.8)°F to 111.2°F 0.1°C
25°C to (high limit -1) °C 0.2°F
Temp Low
77°F to (high limit -1.8)°F

Statistical Results of Clinical Investigation Data

Clinical BIAS Limits of Clinical
(Δcb) Agreement (LA) Repeatability (σr)
Oral 0.02 0.33 0.1
Axilla 0.06 0.38 0.13
Rectum -0.05 0.48 0.14

A-10
THP79JU Infrared Ear Thermometer
Technique Infrared
Measurement range 32°C to 42.2°C (89.6°F to 108°F)

GeniusTM 2 Tympanic Tethered Thermometer

Operating mode Adjusted mode

Response time 2 seconds
Ear: 33.0°C to 42.0°C (91.4°F to 107.6°F)
Oral: 33.6°C to 42.0°C (92.5°F to 107.6°F)
Measurement range
Core: 34.0°C to 42.0°C (93.2°F to 107.6°F)
Rectal: 34.2°C to 42.0°C (93.6°F to 107.6°F)
Ambient Temp Target Temp Accuracy
36.7°C to 38.9°C
25°C (77°F) ±0.1°C (±0.2°F)
Calibrated accuracy limits (98.1°F to 102°F)
16°C to 33°C 33°C to 42°C
±0.2°C (±0.4°F)
(60.8°F to 91.4°F) (91.4°F to 107.6°F)
Resolution 0.1°C or 0.1°F

A.6.5 CO2
Standard Meet standard of ISO 80601-2-55
Technique Infrared absorption
Apnea time 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s
CO2 measurement range 0 to 20%

Full accuracy mode:

CO2 concentration<1 % ±0.1%
1%≤ CO2 concentration<5%: ±0.2%
5%≤ CO2 concentration<7%: ±0.3%
7%≤ CO2 concentration<12%: ±0.4%
CO2 accuracy
12%≤ CO2 concentration≤ 13%: ±0.5%
13% <CO2 concentration≤ 20%: ±0.43%+8%rel
CO2 concentration>20%: unspecified
ISO accuracy mode:
Add ±0.3%ABS to the full accuracy
CO2 accuracy drift Meet the requirement for measurement accuracy within 6 hours.

A-11
CO2 resolution 1 mmHg
Sample flow rate 50 ml/min
Sample flow rate
15% or 15 ml/min, whichever is greater.
tolerance
Start-up time < 90 s
Response time 5 s @ 50ml/min
Rise time < 200 ms @ 50ml/min
awRR measurement range 0 to 150 rpm
awRR measurement <60 bpm: ±1
precision 60 to 150 bpm: ±2
awRR resolution 1 rpm
Effect of interference gases on CO2 measurement
Quantitative
Gas Concentration (%)
effect*
N2O ≤ 60
Hal ≤4
Sev ≤5 ±1 mmHg
Iso ≤5
Enf ≤5
Des ≤ 15 ±2 mmHg
*: means an extra error should be added in case of gas interference when CO2 measurements
are performed between 0 to 40mmHg. Inaccuracy specifications are affected by the breath
rate and I:E change. The end-tidal gas reading is within specification for breath rate below
15BPM and I:E ratio smaller than 1:1 relative to the gas readings without breath.
Alarm limit Range Step
EtCO2 High (low limit + 2) to 99 mmHg
EtCO2 Low 1 to (high limit - 2) mmHg 1 mmHg
FiCO2 High 1 to 99 mmHg
Adult, pediatric: (low limit + 2) to 100 rpm
awRR High
Neonate: (low limit + 2) to 150 rpm 1 rpm
awRR Low 0 to (high limit - 2) rpm

A-12
B EMC and Radio Regulatory Compliance

B.1 EMC
The device meets the requirements of IEC 60601-1-2.

NOTE
 Using accessories, transducers and cables other than those specified may result
in increased electromagnetic emission or decreased electromagnetic immunity
of the patient monitoring equipment.
 The device or its components should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the device or its
components should be observed to verify normal operation in the
configuration in which it will be used.
 The device needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided below.
 Other devices may interfere with this device even though they meet the
requirements of CISPR.
 When the inputted signal is below the minimum amplitude provided in
technical specifications, erroneous measurements could result.
 Portable and mobile communication equipment may affect the performance of
this monitor.
 Other devices that have RF transmitter or source may affect this device (e.g. cell
phones, PADs, PCs with wireless function).

B-1
Guidance and Declaration - Electromagnetic Emissions
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
Emission tests Compliance Electromagnetic environment - guidance
Radio frequency (RF) Group 1 The device uses RF energy only for its
emissions CISPR 11 internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic
equipment.
RF emissions CISPR 11 Class A The device is suitable for use in all
establishments other than domestic and
Harmonic emissions Class A
those directly connected to the public
IEC61000-3-2
low-voltage power supply network that
Voltage Complies supplies buildings used for domestic
Fluctuations/Flicker purposes
Emissions IEC 61000-3-3

WARNING
 This device is intended for use by healthcare professionals only. This
equipment/ system may cause radio interference or may disrupt the operation
of nearby equipment. It may be necessary to take mitigation measures, such as
re-orienting or relocating the [ME EQUIPMENT or ME SYSTEM] or shielding the
location.

If the system is operated within the electromagnetic environment listed in Table

Guidance and Declaration ------Electromagnetic Immunity, the system will remain safe
and provide the following essential performance,
 Operating mode
 Accuracy
 Function
 Accessories identification
 Data stored
 Alarm
 Detect for connection

B-2
Guidance and Declaration - Electromagnetic Immunity
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
Electromagnetic
Immunity test IEC60601 test level Compliance level
environment - guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood,
discharge (ESD) ±8 kV air ±8 kV air concrete or ceramic tile. If
IEC 61000-4-2 floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality
transient/burst supply lines supply lines should be that of a typical
IEC 61000-4-4 ±1 kV for ±1 kV for commercial or hospital
input/output lines input/output lines environment.

Surge IEC ±1 kV line(s) to ±1 kV line(s) to

61000-4-5 line(s) line(s)
±2 kV line(s) to earth ±2 kV line(s) to earth
Voltage dips, <5 % UT (>95 % dip <5 % UT (>95 % dip Mains power quality
short in UT) for 0.5 cycle in UT) for 0.5 cycle should be that of a typical
interruptions commercial or hospital
and voltage environment. If the user of
40 % UT (60 % dip in 40 % UT (60 % dip in
variations on our product requires
UT) for 5 cycles UT) for 5 cycles
power supply continued operation
input lines IEC during power mains
61000-4-11 70 % UT (30 % dip in 70 % UT (30 % dip in interruptions, it is
UT) for 25 cycles UT) for 25 cycles recommended that our
product be powered from
<5 % UT (>95 % dip <5 % UT (>95 % dip an uninterruptible power
in UT) for 5 s in UT) for 5 s supply or a battery.

Power 3 A/m 3 A/m Power frequency

frequency magnetic fields should be
(50/60 HZ) at levels characteristic of a
magnetic field typical location in a typical
IEC 61000-4-8 commercial or hospital
environment.
Note: UT is the AC mains voltage prior to application of the test level.

B-3
Guidance and Declaration - Electromagnetic Immunity
The device is intended for use in the specified electromagnetic environment. The customer or
the user of the device should assure that it is used in such an environment as described below.
Immunity test IEC60601 test Compliance Electromagnetic environment -
level level guidance
Conduced RF 3 Vrms 3Vrms Portable and mobile RF communications
IEC61000-4-6 150 kHz to 80 equipment should be used no closer to
MHz any part of the system, including cables,
than the recommended separation
distance calculated from the equation
appropriate for the frequency of the
transmitter. Recommended separation
distances:
d  1 .2 P
Radiated RF 3V/m 3V/m Recommended separation distances:
IEC61000-4-3 80MHz to 80 MHz～800 MHz
2.5GHz
d  1 .2 P
800MHz-2.5GHz
d  2 .3 P
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).b
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey a,should be less than the
compliance level in each frequency range
b
.
Interference may occur in the vicinity of
equipment marked with the following

symbol:
Note 1: At 80 MHz to 800 MHz, the separation distance for 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.
Note 3: The device that intentionally receives RF electromagnetic energy at the exclusion
band (2395.825MHz-2487.645MHz) is exempt from the ESSENTIAL PERFORMANCE
requirements, but remains safe.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)

B-4
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 [ME EQUIPMENT or ME
SYSTEM] is used exceeds the applicable RF compliance level above, the [ME EQUIPMENT or ME
SYSTEM] should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the [ME EQUIPMENT
or ME SYSTEM].
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than3V/m.

WARNING
 The device is configured with a wireless network connector to receive wireless
signal. Other devices may interfere with this device even though they meet the
requirements of CISPR.

Recommended separation distances between portable and mobile RF communications

equipment and the device
The device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the device as recommended below,
according to the maximum output power of the communications equipment.
Rated Separation distance in meters (m) according to frequency of the
maximum transmitter
output power
150 kHz ～ 80 MHz 80 MHz ～ 800 MHz 800 MHz ～ 2.5 GHz
of transmitter
（W） d  1 .2 P d  1 .2 P d  2 .3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.20 1.20 2.30
10 3.80 3.80 7.30
100 12.00 12.00 23.00
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated 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.
Note 1: At 80 MHz and 800 MHz, the separation distance for 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.

B-5
B.2 Radio Regulatory Compliance
RF parameters (For MSD45N Wireless Module)
Item IEEE 802.11b/g/n IEEE 802.11a/n
5180~5240
Operating Frequency
2412~2472 5260~5320
Band (MHz)
5500~5700
802.11b: DSSS
(DBPSK/DQPSK/CCK) OFDM
Modulation
802.11g/n: OFDM (BPSK/QPSK/16QAM/64QAM)
(BPSK/QPSK/16QAM/64QAM)

Transmitter Output <20 (Average) <20 (Average)

Power (dBm) <30 (Peak) <30 (Peak)

The radio module MSD45N is complied with the essential requirements and other
relevant provisions of Directive 1999/5/EC (Radio Equipment and Telecommunications
Terminal Equipment Directive).

The device, including the MSD45N wireless module, complies with part 15 of the FCC
Rules. Operation is subject to the condition that this device does not cause harmful
interference.

Operation of this equipment requires the prior coordination with a frequency coordinator
designated by the FCC for the Wireless Medical Telemetry Service.

This device complies with Canadian ICES-001. Cet appareil ISM est conforme a la norme
NMB-001 du Canada.

The device, including the MSD45N wireless module, FCC and Industry Canada Radio
Compliance: This device complies with Part 15 of the FCC Rules and RSS-210 of Industry
Canada. 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. Any changes or modifications
to this equipment not expressly approved by Mindray may cause harmful radio frequency
interference and void your authority to operate this equipment.

The maximum antenna gain permitted complies with the e.i.r.p. limits as stated in
RSS-210.

The maximum antenna gain permitted complies with the e.i.r.p. limits specified for

B-6
point-to-point operation, as stated in RSS-210.

WARNING
 Keep a distance of at least 20cm away from the monitor when Wi-Fi function is
in use.

B-7
FOR YOUR NOTES

B-8
C Default Configurations

This chapter lists some of the most important factory default settings in configuration
management. You cannot change the factory default configuration itself. However, you
can make changes to the settings from the factory default configuration and then save
the changed configuration as a user configuration.

C.1 Parameter Configuration

C.1.1 NIBP
Saved at Power Affected by
Name Default
Failure Defaults
Alarm On/Off On Yes Yes
Alarm Priority Med Yes Yes
Interval Manual Yes Yes
Clock On Yes Yes
NIBP End Tone 0 Yes Yes
Program Program 1 Yes Yes
Adult 80
Cuff Press. in
VeniPuncture Pediatric 60 Yes Yes
(mmHg)
Neonate 40
Adult 160
Initial Pressure
Pediatric 140 Yes No
Neonate 90
Adult 160
NIBP-Sys High
Pediatric 120 Yes Yes
(mmHg)
Neonate 90
Adult 90
NIBP-Sys Low
Pediatric 70 Yes Yes
(mmHg)
Neonate 40
Adult 110
NIBP-Mean
Pediatric 90 Yes Yes
High (mmHg)
Neonate 70
NIBP-Mean Adult 60 Yes Yes

C-1
 Saved at Power Affected by
Name Default
Failure Defaults
Low (mmHg) Pediatric 50
Neonate 25
Adult 90
NIBP-Dia High
Pediatric 70 Yes Yes
(mmHg)
Neonate 60
Adult 50
NIBP-Dia Low
Pediatric 40 Yes Yes
(mmHg)
Neonate 20

C.1.2 SpO2
Saved at Power Affected by
Name Default Config
Failure Defaults
Alarm On/Off On
Alarm Priority Med
Adult/pediatric:100
SpO2 High
Neonate: 95
SpO2 Low 90
Yes Yes
Desat Low 80
Sat-Seconds (Nellcor) 0s
NIBP Simultaneous Off
Sweep 25 mm/sec
Beat Volume 2
Monitor mode: Low
SpO2 Sensor Off Lev. Yes No
Spot Check mode: Off
Sensitivity (Mindray) Med
Sensitivity (Masimo) Normal Yes Yes
Averaging (Masimo) 8s

C-2
C.1.3 PR
Saved at Power Affected by
Name Default Config
Failure Defaults

Alarm On/Off On
Alarm Priority Med
Adult 120
PR High Pediatric 160
Neonate 200
Yes Yes
Adult 50
PR Low Pediatric 75
Neonate 100
PR Source SpO2
Beat Volume 2

C.1.4 Temp
Configured with SmarTempTM Module
Saved at Power Affected by
Name Default Config
Failure Defaults
Alarm On/Off Off Yes Yes
Alarm Priority Med Yes Yes
Temp High 38.0 Yes Yes
Temp Low 35.0 Yes Yes
Temp Type Predictive No No
Oral/Axillary probe:
Oral for adult and pediatric
Temp Position No No
Axillary for neonate
Rectal probe: Rectal

Configured with GeniusTM 2 Module

Saved at Power Affected by
Name Default Config
Failure Defaults

Temp Position Ear Yes No

C-3
Temp unit °C Yes No

C.1.5 CO2
Saved at Power Affected by
Name Default Config
Failure Defaults

Parameter-RR

Alarm On/Off On
Alarm Priority Med
Yes Yes
RR High 30
RR Low 8
Parameter-EtCO2
Alarm On/Off On
Alarm Priority Med
Yes Yes
EtCO2 High 50
EtCO2 Low 25
Parameter-FiO2
Alarm On/Off On
Alarm Priority Med Yes Yes
FiCO2 High 4

Apnea Delay 20 s Yes Yes

Operating Mode Measure Yes No
BTPS Compensate Off
Scale 50
Sweep 6.25 mm/s
Wave Type Draw
Yes Yes
O2 Compensate 21
N2O Compensate 0
AA Compensate 0
Auto Standby 60 min

C-4
C.2 General configuration
C.2.1 Alarm
Saved at Power Affected by
Name Default Config
Failure Defaults

Latching Alarm Off

Minimum Alarm Volume 2
High Alarm Interval (s) 10s
Med Alarm Interval (s) 20s Yes No
Low Alarm Interval (s) 20s
Reminder Tone On
Alarm Light on Alarm Reset On

C.2.2 Review
Saved at Power Affected by
Name Default Config
Failure Defaults

Name/MRN button MRN

Spot Check Option for All
Trends Name/MRN button
Filter All
Name/MRN button MRN
Yes No
Continuous Option for Current patient
Trends Name/MRN button
Interval 30s
Graphic
Zoom 6h
Trends

C.2.3 Record
Saved at Power Affected by
Name Default Config
Failure Defaults
SpO2 wave Selected
Yes No
Manual Inputs Selected

C-5
C.2.4 Others
Saved at Power Affected by
Name Default Config
Failure Defaults

Brightness 5
Alarm Volume 2
Key Volume 2 Yes Yes
Display Setup All Parameters
Parameter Time Out 15min
Height cm
Weight kg
Pressure mmHg
Yes No
Temp ℃
Glucose mg/dl
I/O Fluid ml
Date Current date / /
Time Current time / /
Date Format yyyy-mm-dd Yes No
Time Format 24h Yes No

C.3 User Maintenance Items

Saved at Power Affected by
Name Default Config
Failure Defaults

Spot Check Off

SpO2 Tone Mode 1
Clinician ID Time Out 10 min
Language English
Yes No
Network Type LAN
Select CMS On
Clear CMS IP at Startup Off
Data Send Method HL7 Direct Send

C-6
D Alarm Messages

This chapter lists only the most important physiological and technical alarm messages.
Some messages appearing on your monitor may not be included. In the ‘‘Solution’’
column, corresponding solutions are given instructing you to troubleshoot problems. If
the problem persists, contact your service personnel.

D.1 Physiological Alarm Messages

Alarm Alarm Cause Solution
Message Priority
XX value exceeds the upper Check the patient’s
XX Too High Med*
alarm limit. condition and check if the
patient category and
XX value is lower than the alarm limit settings are
XX Too Low Med*
lower alarm limit. correct.
Check the patient’s
The SpO2 value has fallen
condition and check if the
SpO2 Desat High below the desaturation alarm
alarm limit settings are
limit.
correct.
The pulse signal was so weak Check the patient’s
No Pulse High that the monitor cannot condition, SpO2 sensor
perform pulse analysis. and measurement site.
The patient stops breathing, or
Check the patient’s
the respiration signal was so
Apnea High condition, module and
weak that the monitor cannot
patient connections.
perform respiration analysis.
‘‘*’’ means the alarm level is user-adjustable.
XX represents a measurement or parameter label, such as NIBP, PR, etc.

D.2 Technical Alarm Messages

D.2.1 NIBP Module Alarm Messages
Alarm Clearable? Alarm Cause Solution
Message (Yes/No) Level

NIBP-Sys Limit
No Low
Err
The alarm limit of
NIBP-Dia Limit the parameter is Contact your service
No Low
Err changed personnel.
inadvertently.
NIBP-Mean
No Low
Limit Err

D-1
Alarm Clearable? Alarm Cause Solution
Message (Yes/No) Level

NIBP-Sys Over Yes Low The measured Check the patient’s

Upper Limit pressure is greater condition and keep the
than the specified patient relaxed and still. If
NIBP-Dia Over Yes Low
NIBP measurement the error remains, contact
Upper Limit
upper limit. Mindray or your service
NIBP-Mean Yes Low personnel.
Over Upper
Limit
NIBP-Sys Over Yes Low The measured Check the patient’s
Lower Limit pressure is lower condition and keep the
than the specified patient relaxed and still. If
NIBP-Dia Over Yes Low
NIBP measurement the error remains, contact
Lower Limit
lower limit. Mindray or your service
NIBP-Mean Yes Low personnel.
Over Lower
Limit
SelfTest Failed. The Restart the monitor and
NIBP SelfTest cause may be the retry. If the error remains,
Yes High
Err transducer or A/D contact your service
sampling error. personnel.
An error occurred to
the NIBP module, or
there is a problem Restart the monitor. If the
NIBP Init Err Yes Low with the error remains, contact our
communications service personnel.
between the module
and the monitor.
An error occurred to
the NIBP module, or
there is a problem Restart the monitor. If the
NIBP Comm
Yes High with the error remains, contact our
Err
communications service personnel.
between the module
and the monitor.
Check the patient’s
condition and verify
The NIBP cuff is not patient type. Replace with
NIBP Loose properly connected, an appropriate cuff and
Yes Low
Cuff or there is a leak in connect it correctly. If the
the airway. problem still exists,
contact your service
personnel.

D-2
Alarm Clearable? Alarm Cause Solution
Message (Yes/No) Level

Check the air pressure.

Restart the monitor and
NIBP Air An error occurred to
Yes Low retry. If the error remains,
Pressure Err the air pressure.
contact your service
personnel.
Check the patient’s
The patient’s pulse is condition and change the
NIBP Weak
Yes Low weak or the cuff is cuff application site. If the
Signal
loose. error persists, replace the
cuff.
The measured NIBP
NIBP Contact your service
Yes Low value is not within
Overrange personnel.
the specified range.
NIBP Check the patient’s
Patient’s arm moves
Excessive Yes Low condition and reduce the
too much.
Motion patient motion.
NIBP Cuff The NIBP airway may Check the airway and
Yes Low
Overpress. be occluded. measure again.
Check the patient’s
NIBP Signal The NIBP signal is condition and reduce the
Yes Low
Saturated saturated. patient motion or other
sources.
The NIBP cuff is not
The NIBP airway may properly connected, or
NIBP Air Leak Yes Low
leak air. there is a leak in the
airway.
System error; or
pump, A/D sampling
or pressure
NIBP Equip Err Yes High
transducer error; or
pointer error during
software running. Check the patient’s
Time is out. In condition and NIBP
Adult/Pediatric connections, or replace
mode, the the cuff.
measurement time
NIBP Timeout Yes Low
is over 120 seconds;
in neonate mode,
the time is over 90
seconds.

D-3
Alarm Clearable? Alarm Cause Solution
Message (Yes/No) Level

The cuff type

NIBP Cuff Verify the patient category
Yes Low applied mismatches
Type Wrong and replace the cuff.
the patient category.
An illegal reset
NIBP Illegally Check if the airway is
Yes Low occurred during
Reset occluded.
NIBP measurement.
System deflates the
VeniPuncture
Yes Low cuff after a certain /
timeout
time.

D.2.2 SpO2 Alarm Messages

Alarm Clearable? Alarm Cause Solution
Message (Yes/No) Level

SpO2 Sensor Low*(Mon

Off itor mode)
(Mindray, Yes Off* (Spot
Masimo, Check
Nellcor) mode)
The SpO2 sensor
SpO2 Sensor
has become
Fault Check the sensor
No Low detached from the
(Mindray, application site and the
patient or the
Masimo) sensor type, and make
module, or there is
sure if the sensor is
SpO2 No a fault with the
damaged. Reconnect the
Sensor SpO2 sensor, or an
sensor or use a new
Yes Low unspecified SpO2
(Mindray, sensor.
sensor has been
Masimo,
used.
Nellcor)
SpO2
Unknown
Sensor No Low
(Masimo)

SpO2 Too Move the sensor to a place

Much Light There is too much with lower level of
No Low light on the SpO2 ambient light or cover the
(Mindray, sensor. sensor to minimize the
Masimo) ambient light.
SpO2 No
Pulse SpO2 sensor failed
Move the sensor to a site
No Low to obtain pulse
(Mindray, with better perfusion.
signal.
Nellcor)

D-4
SpO2 Comm
Stop
No High An error occurred
(Mindray,
to the SpO2
Masimo,
module, or there is
Nellcor)
a problem with Restart the monitor. If the
SpO2 Comm the error remains, contact
Abnormal communications your service personnel.
(Mindray, Yes High between the
Masimo, module and the
Nellcor) monitor.

SpO2 Init Err Yes High

SpO2 Board There is a problem

Do not use the module
Fault with the SpO2
No Low and contact your service
measurement
(Masimo) personnel.
board.
SpO2 Low
Signal No Low
(Masimo) The SpO2 signal is
Adjust the sensor
too low or too
SpO2 Weak application site.
weak.
Signal No Low
(Nellcor)
Check for any possible
SpO2 The SpO2 signal sources of signal noise
Interference No Low has been around the sensor and
(Masimo) interfered. check the patient for great
motion.
An error occurred
to the SpO2
module, or there is
SpO2 Comm
a problem with Restart the monitor. If the
Err (Mindray,
Yes High the error remains, contact our
Masimo,
communications service personnel.
Nellcor)
between the
module and the
monitor.
SpO2 Limit Err
The alarm limit of
(Mindray, Contact your service
No Low SpO2 is changed
Masimo, personnel.
inadvertently.
Nellcor)
PR Limit Err
The alarm limit of
(Mindray, Contact your service
No Low PR is changed
Masimo, personnel.
inadvertently.
Nellcor)

D-5
PR Overrange The measured PR
(Mindray, value exceeds the Contact your service
No Low
Masimo, measurement personnel.
Nellcor) range.
‘‘*’’ means the alarm level is user-adjustable.

D.2.3 Temperature Alarm Messages

Alarm Clearable? Alarm Cause Solution
Message (Yes/No) Level

An error occurred to
the Temp module, or
there is a problem
Restart the monitor. If the
Temp Init with the
Yes High error remains, contact
Err communications
your service personnel.
between the module
and the monitor, or
Temp calibration error.
An error occurred to
the Temp module, or
there is a problem Restart the monitor. If the
Temp
No High with the error remains, contact our
Comm Err
communications service personnel.
between the module
and the monitor.
The alarm limit of
Temp Alarm Contact your service
No High Temp is changed
Limit Err personnel.
inadvertently.
The initial probe
Warmup temperature in
Yes Med Cool the probe and retry.
Timed Out measurement is too
high.
The thermal resistor
on the temperature
Warming Replace temperature
No Med probe has an error
Resistor Err probe.
(Can not work
properly).
The environmental
Ambient
temperature is out the Change an environment
Temp Yes Med
range of the monitor's and retry.
Overrange
measurement.
Temp The voltage is too high
Yes Med Check the power supply.
Voltage Err or too low.

D-6
Temp
The measuring
Prediction Yes Low Retry to measure.
operation is improper.
Err
An error occurs during
Temp
No High Temp module Replace the module.
SelfTest Err
initialization.
The patient's
Reduce the patient's
Temp Over temperature is too
No High temperature, or replace
High Limit high, or an error
the module.
occurs.
The patient's Raise the patient's
Temp Over
No High temperature is too temperature, or replace
Low Limit
low, or an error occurs. the module.
Temp No The probe is
Yes Med Reconnect the probe.
Probe disconnected.
The temperature 1 Check if the probe well is
Temp Probe probe is not well installed.
Yes Med
Misplaced placed, or not inserted 2 Properly re-insert the
into probe well. probe into probe well.
Temp The measuring time is Return the sensor to the
Measuring Yes Med over 5 minutes in probe well, and take a
Timeout Monitor mode. temperature again.

D.2.4 CO2 Alarm Messages

Alarm Clearable? Alarm Cause Solution

Message (Yes/No) Level

CO2 Comm No High

Err An error occurred to
the CO2 module, or
CO2 Comm No High there is a problem Restart the monitor. If the
Abnormal with the error remains, contact our
CO2 Comm No High communications service personnel.
Stop between the module
and the monitor.
CO2 Init Err No High
CO2 SelfTest No High An error occurs during
Err CO2 module Replace the module.
initialization.

D-7
 Lower the operating
temperature.
Ambient temperature
CO2 Sensor If the alarm persists, the
No Low is too high or there is a
High Temp CO2 module may fail.
module failure.
Contact your service
personnel.
Check the CO2
CO2 Zero connections. If the alarm
No Low The zeroing failed.
Failed persists, contact your
service personnel.
CO2 No The sample line is off Make sure that the sample
Yes Low
Filterline or disconnected. line is connected.
CO2
The airway or water Check the airway and
FilterLine No Low
trap is occluded. remove the occlusion.
Occluded
The measured
parameter or
XX Contact your service
No Low measurement XX
Overrange personnel.
value is not within the
specified range.
XX represents a measurement or parameter label.

D.2.5 Recorder Alarm Messages

Alarm Clearable? Alarm Cause Solution
Message (Yes/No) Level

Recorder Init Yes Low An error occurred to Restart the monitor. If the
Error the module, or there is problem still exists,
a problem with the contact your service
Recorder
Yes Low communication personnel.
selftest Error
between the module
Recorder and the monitor.
Yes Low
Unavailable
Recorder
Yes Low
Comm Error
Recorder Vlt There is a problem If the message is
No Low
High with the system power prompted for several
Recorder Vlt supply. Restart the times, contact your service
No Low monitor. personnel.
Low
Stop the recording and
The recorder has been
Recorder resume the recording till
No Low working for too long
Head Hot the recorder’s print head
time.
cools down.

D-8
Alarm Clearable? Alarm Cause Solution
Message (Yes/No) Level

The thermal head of Restore the control lever

Rec Head
Yes Low the recorder is in of the recorder to its
Wrong Pos.
wrong position. previous position.
Recorder out The recorder paper is Replace with a new paper
Yes Low
of paper used up. roll.

D.2.6 Power Alarm Messages

Alarm Clearable? Alarm Cause Solution
Message (Yes/No) Level

12V Too High No High

12V Too Low No High
There is a
5V Too High No High Restart the monitor. If the
problem with the
problem still exists, contact
5V Too Low No High system power
your service personnel.
supply.
3.3V Too High No High
3.3V Too Low No High
Battery Too The battery
No Med Connect the monitor to an AC
Low charge is too low.
power source and allow the
The battery batteries to charge
Battery
No High charge is almost immediately.
Depleted
depleted.
No data from
Restart the monitor. If the
Power Board power module
No High problem still exists, contact
Comm Err has been received
your service personnel.
for 5 seconds.
Reset the system time and
RT Clock Need Button cell restart the monitor. If the
No Low
Reset problem problem still exists, contact
your service personnel.
PWR Yes Low Power supply to Check the measurements
interrupted. the monitor was when the monitor restarts. If
Check meas. interupted. the problem still exists,
State. contact your service
personnel or Mindray.

D-9
D.2.7 System Alarm Messages
Alarm Clearable? Alarm Cause Solution
Message (Yes/No) Level

No CMS Yes Low The monitor is Check network connection.

disconnected from
the CMS.

D-10
E 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 complying with IEC 60601-1 used in
Europe such as Fluke, Metron, or Gerb may require modifications to the procedure. Follow
the instructions of the analyzer manufacturer.

he electrical safety inspection should be periodically performed every two years .The
safety analyzer also proves to be an excellent troubleshooting tool to detect
abnormalities of line voltage and grounding, as well as total current loads.

E.1 Power Cord Plug

E.1.1 The Power Plug
Test Item Acceptance Criteria
The power plug pins No broken or bent pin. No discolored pins.
The plug body No physical damage to the plug body.
The power plug No physical damage to the strain relief. No plug
The strain relief
warmth for device in use.
The power plug No loose connections.
No physical damage to the cord. No deterioration
to the cord.
For devices with detachable power cords, inspect
The power cord
the connection at the device.
For devices with non-detachable power cords,
inspect the strain relief at the device.

E-1
E.2 Device Enclosure and Accessories
E.2.1 Visual Inspection
Test Item Acceptance Criteria
No physical damage to the enclosure and accessories.

The enclosure and No physical damage to meters, switches, connectors, etc.

accessories No residue of fluid spillage (e.g., water, coffee, chemicals, etc.).
No loose or missing parts (e.g., knobs, dials, terminals, etc.).

E.2.2 Contextual Inspection

Test Item Acceptance Criteria
No unusual noises (e.g., a rattle inside the case).
The enclosure and No unusual smells (e.g., burning or smoky smells, particularly
accessories from ventilation holes).
No taped notes that may suggest device deficiencies or operator
concerns.

E.3 Device Labeling

Check the labels provided by the manufacturer or the healthcare facility are present and
legible.
 Main unit label
 Integrated warning labels

E.4 Protective Earth Resistance

1. Plug the probes of the analyzer into the device’s protective earth terminal and
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 limits.

LIMITS
ALL COUNTRIES R = 0.2 Ω Maximum

E-2
E.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),
 normal polarity with open neutral (Single Fault Condition),
 reverse polarity with open neutral (Single Fault Condition)

LIMITS
For UL60601-1,
 300 μA in Normal Condition
 1000 μA in Single Fault Condition

For IEC60601-1,
 500 μA in Normal Condition
 1000 μA in Single Fault Condition

E.6 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 CF applied parts
 10μA in Normal Condition
 50μA in Single Fault Condition

E-3
 For BF applied parts
 100μA in Normal Condition
 500μA in Single Fault Condition

E.7 Mains on Applied Part Leakage

The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage,
through 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) to 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 CF applied parts: 50 μA

 For BF applied parts: 5000 μA

NOTE

 Make sure the safety analyzer is authorized comply with requirement of IEC
60601-1.
 Follow the instructions of the analyzer manufacturer.

E-4
F Symbols and Abbreviations

F.1 Symbols
μA microampere
μV microvolt
μs Microsecond
A ampere
Ah ampere hour
bpm beat per minute
bps bit per second
ºC centigrade
cm centimeter
dB decibel
DS dyne second
ºF fahrenheit
g gram
GHz gigahertz
h hour
Hz hertz
in inch
k kilo
kg kilogram
kPa kilopascal
L litre
lb pound
m meter
mAh milliampere hour
Mb mega byte
mg milligram
min minute
ml milliliter
mm millimeter

F-1
mmHg millimeters of mercury
ms millisecond
mV millivolt
mW milliwatt
MΩ megaohm
nm nanometer
rpm breaths per minute
s second
V volt
VA volt ampere
Ω ohm
W watt
－ minus
– negative
％ percent
/ per; divide; or
～ to
＋ plus
＝ equal to
＜ less than
＞ greater than
≤ less than or equal to
≥ greater than or equal to
± plus or minus
× multiply
© copyright

F-2
F.2 Abbreviations
AAMI Association for Advancement of Medical Instrumentation
AC alternating current
ADT Admit/Discharge/Transfer
Adu adult
AVPU Alert, Reacting to Voice, Reacting to Pain, and Unresponsive
CE Conformité Européenne
CISPR International Special Committee on Radio Interference
CMOS complementary metal oxide semiconductor
CMS central monitoring system
COPD Chronic Obstructive Pulmonary Disease
DC direct current
Dia diastolic
DPI dot per inch
EEC European Economic Community
EMC electromagnetic compatibility
EMI electromagnetic interference
EMR Electronic Medical Record
GCS Glasgow Coma Scale
ID identification
IEC International Electrotechnical Commission
ISO International organization for standardization
IEEE Institute of Electrical and Electronic Engineers
IP internet protocol
IPS Individual Parameter Score
LED light emitting diode
MDD Medical Device Directive
MetHb methemoglobin
MEWS Modified Early Warning Score
MRI magnetic resonance imaging
N/A not applied
Neo neonate
NEWS National Early Warning Score

F-3
NIBP noninvasive blood pressure
NIBP-D NIBP-diastolic pressure
NIBP-M NIBP-mean pressure
NIBP-S NIBP-systolic pressure
P power
PD photodetector
Ped pediatric
Pleth plethysmogram
PR pulse rate
RAM random access memory
ROM read-only memory
SpO2 arterial oxygen saturation from pulse oximetry
TD temperature difference
TEMP temperature

F-4
P/N: 046-004883-00 (7.0)