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H-046-007673-00-6.0 UniBase 30 User Manual (EN)

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0% found this document useful (0 votes)
622 views106 pages

H-046-007673-00-6.0 UniBase 30 User Manual (EN)

Uploaded by

Mio Azelander
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 106

UniBase 30 Series

Operating Table

Operator’s Manual
Copyright

This product is provided with a CE marking in accordance with the regulations stated in
Regulation(EU) 2017/745 concerning Medical Devices.

The device complies with the requirements of EN/IEC 60601-1-2 “Electromagnetic


Compatibility – Medical Electrical Equipment”.

© 2015-2021 Nanjing Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.

For this Operator’s Manual, the issued date is 2021-03 (Version: 6.0).

Intellectual Property Statement


NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray)
owns the intellectual property rights to this Mindray device and this manual. This manual can
refer to information protected by copyrights or patents and does not convey any license under
the patent rights or copyright of Mindray, or of others.

Mindray intends to maintain the contents of this manual as confidential information.


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

Release, amendment, reproduction, distribution, rental, adaption and translation or any other
derivative work of this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden.

, , are the trademarks, registered or otherwise, owned by

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. UniBase, are the

trademarks, registered or otherwise, owned by Nanjing Mindray Bio-Medical Electronics Co.,


Ltd in China and other countries. All other trademarks that appear in this manual are used
only for informational or editorial purposes. They are the property of their respective owners.

I
Responsibility on the Manufacturer Party
Contents of this manual are subject to change without prior notice.

All information contained in this manual is believed to be correct. Mindray shall not be liable
for errors contained herein or for incidental or consequential damages in connection with the
furnishing, performance, or use of this manual.

Mindray is responsible for the effects on safety, reliability and performance of this device, only
if:

 all installation operations, expansions, changes, modifications and repairs of this device
are conducted by Mindray authorized personnel.

 the electrical installation of the relevant room complies with the applicable national and
local requirements, and

 the device is used in accordance with the instructions for use.

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

 It is important for the hospital or organization that employs this device 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 device 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 device or part whose serial number is not legible enough.
 Others not caused by device or part itself.

Notification of Adverse Events


As a health care provider, you may report the occurrence of certain events to NANJING
MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., and possibly to the competent
authority of the member state in which the user and / or patient is established.

These events include device-related death and serious injury or illness. In addition, as part of
our Quality Assurance Program, NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,
LTD. requests to be notified of device failures or malfunctions. This information is required to
ensure that NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. provides only the
highest quality products.

III
Return Policy

Return Procedure
In the event that it becomes necessary to return this device or part of this device to Mindray,
the following procedure should be followed:

Return authorization: Contact the Customer Service Department and obtain a Customer
Service Authorization number. This number must appear on the outside of the shipping
container. Returned shipments will not be accepted if the number is not clearly visible. Please
provide the model number, serial number, and a brief description of the reason for return.
Freight policy: The customer is responsible for freight charges when this device is shipped to
Mindray for service (this includes customs charges).
Return address: Please send the part(s) or device to the address offered by the Customer
Service Department.

Contact Information
Manufacturer: Nanjing Mindray Bio-Medical Electronics Co., Ltd.
Address: 666# Middle Zhengfang Road, Jiangning, 211111 Nanjing, Jiangsu,
P.R.China
Tel: +86 25 66082666
Fax: +86 755 26582680-26666

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


Address: Eiffestrasse 80, 20537 Hamburg, Germany

Tel: 0049-40-2513175

Fax: 0049-40-255726

IV
Table of Contents
1 System Overview ································································ 1-1
1.1 Main Components ........................................................................... 1-1
1.2 Definitions ....................................................................................... 1-2
1.2.1 Graphical Symbols ................................................................. 1-2
1.2.2 Safety Notes........................................................................... 1-4
1.3 Intended Use ................................................................................... 1-5
1.3.1 Intended Purpose................................................................... 1-5
1.3.2 Intended Users....................................................................... 1-5
1.3.3 Intended Patient Population ................................................... 1-5
1.3.4 Intended Medical Conditions.................................................. 1-5
1.3.5 Contra-indications .................................................................. 1-5
1.3.6 Side-effects ............................................................................ 1-5
1.4 Fundamental Safety Instructions .................................................... 1-6
1.4.1 Instructions against Personal Injury ....................................... 1-6
1.4.2 Instructions against Property Damage ................................... 1-9

2 Daily Operations ································································· 2-1


2.1 Power Supply Systems ................................................................... 2-1
2.1.1 AC Power ............................................................................... 2-1
2.1.2 Battery. ................................................................................... 2-3
2.2 Power Switch .................................................................................. 2-4
2.3 Potential Equalization ..................................................................... 2-5
2.3.1 Setting up Potential Equalization ........................................... 2-5
2.4 Corded Hand Control ...................................................................... 2-6
2.4.1 Connecting and Detaching Corded Hand Control ................. 2-6
2.4.2 Keys……….. .......................................................................... 2-7
2.4.3 Indicator ............................................................................... 2-10
2.4.4 Error Indication ..................................................................... 2-11
2.4.5 Attaching the Corded Hand Control ..................................... 2-12
2.5 Base Cover ................................................................................... 2-13
2.6 Locking/Unlocking the Operating Table ........................................ 2-14
2.6.1 Locking the Operating Table ................................................ 2-14
2.6.2 Unlocking the Operating Table ............................................. 2-14
2.7 Table Pad ...................................................................................... 2-15
2.7.1 Foam Pad............................................................................. 2-15
2.8 Head Plate .................................................................................... 2-17
2.8.1 Removing Head Plate .......................................................... 2-17
2.8.2 Installing Head Plate ............................................................ 2-18
2.8.3 Adjusting Head Plate ........................................................... 2-18
2.9 Leg Plate ....................................................................................... 2-20

1
Table of Contents

2.9.1 Removing Leg Plate ............................................................. 2-20


2.9.2 Installing Leg Plate ............................................................... 2-21
2.9.3 Adjusting Leg Plate .............................................................. 2-21
2.10 Body Elevator (optional)................................................................ 2-23

3 Cleaning and Disinfection ···················································· 3-1


3.1 General ........................................................................................... 3-1
3.1.1 Recommended Cleaning Agents and Disinfectants ............... 3-2
3.1.2 Forbidden Cleaning Agents and Disinfectants ....................... 3-2
3.2 Cleaning .......................................................................................... 3-3
3.2.1 Preparations ........................................................................... 3-3
3.2.2 Cleaning Procedure ............................................................... 3-3
3.3 Disinfection ...................................................................................... 3-5
3.3.1 General .................................................................................. 3-5
3.3.2 Disinfection Procedure ........................................................... 3-5
3.4 Table Pad ........................................................................................ 3-6
3.4.1 Cleaning ................................................................................. 3-6
3.4.2 Disinfection............................................................................. 3-7
3.5 Swivel Castor .................................................................................. 3-8

4 Maintenance ······································································ 4-1


4.1 Inspections and Maintenance ......................................................... 4-1
4.1.1 Inspections ............................................................................. 4-1
4.1.2 Maintenance........................................................................... 4-1

5 Troubleshooting ································································· 5-1

6 Clamp ··············································································· 6-1


6.1 Intended Use ................................................................................... 6-1
6.2 Heavy Radial Clamp ....................................................................... 6-2
6.2.1 Specifications ......................................................................... 6-2
6.2.2 Components ........................................................................... 6-2
6.2.3 Installation and Use ............................................................... 6-2
6.3 Light Radial Clamp .......................................................................... 6-4
6.3.1 Specifications ......................................................................... 6-4
6.3.2 Components ........................................................................... 6-4
6.3.3 Installation and Use ............................................................... 6-5
6.4 Heavy Quadrate Clamp .................................................................. 6-6
6.4.1 Specifications ......................................................................... 6-6
6.4.2 Components ........................................................................... 6-6
6.4.3 Installation and Use ............................................................... 6-6
6.5 Light Quadrate Clamp ..................................................................... 6-8
6.5.1 Specifications ......................................................................... 6-8
6.5.2 Components ........................................................................... 6-8

2
Table of Contents

6.5.3 Installation and Use ............................................................... 6-8


6.6 Cleaning and Disinfection ............................................................. 6-10
6.6.1 Cleaning ............................................................................... 6-10
6.6.2 Disinfection........................................................................... 6-11

7 Anesthesia Frame ······························································· 7-1


7.1 Intended Use ................................................................................... 7-1
7.2 Heavy Anesthesia Frame ................................................................ 7-2
7.2.1 Specifications ......................................................................... 7-2
7.2.2 Components ........................................................................... 7-2
7.2.3 Installation and Use ............................................................... 7-3
7.3 Light Anesthesia Frame .................................................................. 7-4
7.3.1 Specifications ......................................................................... 7-4
7.3.2 Components ........................................................................... 7-4
7.3.3 Installation and Use ............................................................... 7-4
7.4 Cleaning and Disinfection ............................................................... 7-6
7.4.1 Cleaning ................................................................................. 7-6
7.4.2 Disinfection............................................................................. 7-6

8 Arm Board ········································································· 8-1


8.1 Intended Use ................................................................................... 8-1
8.2 Heavy Arm Board ............................................................................ 8-2
8.2.1 Specifications ......................................................................... 8-2
8.2.2 Components ........................................................................... 8-2
8.2.3 Installation and Use ............................................................... 8-3
8.3 Light Arm Board .............................................................................. 8-5
8.3.1 Specifications ......................................................................... 8-5
8.3.2 Components ........................................................................... 8-5
8.3.3 Installation and Use ............................................................... 8-6
8.4 Cleaning and Disinfection ............................................................... 8-7
8.4.1 Cleaning ................................................................................. 8-7
8.4.2 Disinfection............................................................................. 8-7
8.4.3 Cleaning/Disinfecting Pad ...................................................... 8-8
8.4.4 Cleaning Fastening Strap....................................................... 8-9

9 Appendices ······································································· 9-1


A Technical Specifications .................................................................. 9-1
A.1 Classification .......................................................................... 9-1
A.2 Environment ........................................................................... 9-2
A.3 Load ....................................................................................... 9-4
A.4 Specifications ......................................................................... 9-5
A.5 Accessories ............................................................................ 9-9
A.6 EMC ..................................................................................... 9-12
B Index ............................................................................................. 9-18

3
This page is intentionally blank.
1 System Overview

1.1 Main Components

The main components of the operating table are shown in the figure below.

5 4 3 2 1

13 14 15
6 12
7
11

10
8
9
Figure 1-1 Main components

1 Head plate 2 Back plate


3 Body elevator (optional) 4 Seat plate
5 Leg plate 6 Release lever (leg plate up / down)
7 Locking button (leg plate) 8 Brake
9 Castors 10 Base
11 Column 12 Hand crank for body elevator
13 Locking screw (head plate) 14 Release bracket for head plate
15 Lug

1-1
System Overview

1.2 Definitions

1.2.1 Graphical Symbols

You can see the following symbols on the operating table:

Table 1-1 Symbol Definition

Symbol Meaning

Caution, consult accompanying documents

Caution

IPX4 Protection against of water or particulate matter

Type B applied part

No sitting

Protective earth (ground)

Equipotentiality

Alternating current

Direct current

Serial number

Date of manufacture

1-2
System Overview

Manufacturer

Authorized representative in the European Community

Power on/off

Body elevator label

Temperature limitation

Humidity limitation

Atmospheric pressure

WEEE symbol
The following definition of the WEEE label applies to EU
member states only: the use of 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 the product.

ESD warning

Labeling for Class I products. Developed and marketed in


compliance with Regulation (EU) 2017/745.

Medical Device

1-3
System Overview

1.2.2 Safety Notes

Table 1-2 Definition of safety notes

Note Meaning

Read the statement below the symbol. The statement alerts


you to an operating hazard that can cause personal injury.

Read the statement below the symbol. The statement alerts


you to possible property damage.

Read the statement below the symbol. The statement alerts


you to information that requires your attention.

1-4
System Overview

1.3 Intended Use

1.3.1 Intended Purpose


The operating table is intended to support and position patients immediately before, during
and after surgical procedures, as well as for examination and treatment.

1.3.2 Intended Users


The operating table may only be operated by medically trained staff.

1.3.3 Intended Patient Population


The operating table is intended for patients who are in surgical,examination and treatment
procedures.

1.3.4 Intended Medical Conditions


The operating table is used in healthcare facility environment.

1.3.5 Contra-indications
None.

1.3.6 Side-effects
According to the conclusion of clinical evaluation and residual risk evaluation, for the
intended patients, there are no known side effects that can occur during or after the use of the
medical device. And there is no need for the operator to make extra preparations. Thus, no
residual risk associated with using the medical device should be disclosed.

 Contents of this manual are based on the full configuration of the operating
table. Some of them can not apply to your operating table. Use your
operating table according to the actual configuration. If you have any
questions, contact the customer service department authorized by Nanjing
Mindray or your local distributor.

 The operating table is to be operated by trained personnel only. Be sure to


archive the training records.

 Training materials are available. Be sure to contact Nanjing Mindray or your


local distributor for them.

1-5
System Overview

1.4 Fundamental Safety Instructions

1.4.1 Instructions against Personal Injury

 The operating table is to be used for its intended purposes only. Do not use
it for other purposes.

 The operating table is to be installed by personnel authorized by Nanjing


Mindray only.

 The operating table is to be operated by trained personnel only. Be sure to


archive the training records.

 Before using the operating table, be sure to read and fully understand this
manual.

 Be sure to keep the manual at a place nearby the operating table.

 Before unlocking the castors, grasp the operating table. Otherwise, it can
move unexpectedly.

 Before positioning the patient, make sure the patient’s body width is no
greater than the width of the table top. Otherwise it can cause personal
injury.

 The maximum load of this operating table is 185kg. In case of longitudinal


shift, the maximum load of the operating table is 135kg. Make sure it is not
used beyond this limit. However, in case of certain special conditions, the
load capacity is further limited. Be sure to take those conditions into
consideration when using the operating table. If you have any questions,
contact the customer service department authorized by Nanjing Mindray or
your local distributor.

 If accessories are used, make sure the weights of the accessories installed
on the operating table and of the patient add up no more than 185kg or
135kg (after longitudinal shift).

 To avoid infection, be sure to cover the table-top pad with a sterile surgical
drape before transferring the patient.

 Do not use wet surgical drapes on the operating table.

 Transferring the patient inappropriately can tip over the operating table. Be
sure to transfer the patient from either side of the operating table. Do not
transfer the patient from either the head or the foot end.

 Before transferring the patient, make sure the operating table is placed on a

1-6
System Overview

level ground, the castors are properly locked and the table top is in the best
balanced state (table top horizontal and slid to the limit of the foot end).
Placing the patient improperly can tip over the operating table. Be sure to
place the patient in the right direction. Do not place the patient’s trunk on
the leg plates.

 When placing the patient, make sure the patient’s center of gravity is as
close to the column as possible.

 Do not move the operating table when the patient is lying on it.

 Improper body positions can damage the patient, especially in case of


excessive tilted or sloped position. When using this operating table, ensure
proper body positions and regularly check the position during the whole
surgery.

 To avoid damaging the patient’s respiratory system, nervous system or


circulating system, make sure the patient is properly positioned and keep a
close eye on the patient during the whole surgery.

 When using the operating table, be sure to press the exact function key
matching the patient’s body position. Otherwise, the patient can be
damaged.

 Before positioning the patient, make sure the castors are properly locked.

 The speed of table-top movement can change depending on the patient’s


weight. Closely watch the table top during adjustment.

 If the patient weights more than 135kg, do not slope the table top (the
Trendelenburg or Reverse Trendelenburg position) by more than 10º and do
not tilt the table top to the left or right by more than 5º.

 If the table top is already sloped toward the foot end (Reverse
Trendelenburg position), exercise caution when raising the back plate. The
head plate can collide with the patient’s head.

 If the table top is already slid toward the head end, be sure to keep the table
top horizontal. Do not slope or tilt the table top under this condition.

 In case of excessive tilted or sloped body positions, make sure the patient is
well secured.

 Before sliding the table top toward the head end, make sure the table top is
horizontal.

 If the table top is slid toward the head end for the radiological diagnostics
purpose, be sure to return the table top to the balanced state (slid to the limit
of the foot end) before starting the surgery.

 Exercise caution when adjusting the table top or the accessories. Do not
pinch anybody.

 When adjusting the table top or the accessories, carefully watch the
positions of the patient, table top, accessories and other things inside the

1-7
System Overview

operating room. Be sure to keep those things from colliding with each other.

 Make sure the indoor environment complies with the installation


requirements listed in this manual.

 Make sure the ground is level before installing the operating table.

 If the integrity of the external protective conductor in the installation or its


arrangement is in doubt, run the operating table from its internal battery.

 The operating table can function safely and effectively only if it is


maintained properly and regularly. Be sure to maintain the operating table as
instructed in this manual.

 Before maintaining or servicing the operating table, make sure it is


disconnected from the mains supply.

 Complete electrical / safety inspections should be conducted every year by


personnel authorized by Nanjing Mindray.

 This operating is not suitable for use in the presence of a flammable


anesthetic mixture with air or with oxygen or with nitrous oxide.

 Do not use the cleaning agents or disinfectants containing alcohol where


such medical devices as electrosurgical units, defibrillators and defibrillator
monitors may be used. Otherwise, it can cause fire and/or explosion
hazards.

 When using such medical devices as electrosurgical units, defibrillators or


defibrillator monitors, be sure to keep the patient from touching the metallic
parts of the operating table or of the accessories. Moreover, make sure the
patient is not lying on a wet surgical drape or a conductive pad. Otherwise,
the patient can be burned.

 Do not use such devices as cell phones, radio equipment and MR


equipment around the operating table.

 If an antistatic pathway is required, be sure to use the operating table on an


antistatic floor.

 Any equipment connected to the operating table shall comply with the
relevant EN/IEC standards (e.g., EN/IEC 60950 information technology
equipment safety standard, EN/IEC 60601-1 medical equipment standard
and its relevant particular standards, and the like). It is the responsibility of
the people, who connect additional equipment to the operating table and
configure the whole system, to verify that the system complies with the
requirements of EN/IEC 60601-1 and EN/IEC 60601-1-2. If you have any
questions regarding these requirements, consult the customer service
department authorized by Nanjing Mindray or your local distributor.

 Be sure to only use accessories made by Nanjing Mindray on the operating


table. Accessories produced by other manufacturers must not be used if
they affect or modify the longitudinal geometry of the table top, unless their

1-8
System Overview

use is expressly permitted by Nanjing Mindray. Use only spare parts


approved by Nanjing Mindray.

 Before using accessories, be sure to read the operator’s manual thoroughly.

 Used operating tables, including their batteries and accessories, should be


disposed of in compliance with local governmental or hospital regulations.

 The battery has a leakage current that is present even if the operating table
is switched off. This leakage current may exhaust the battery. Make sure the
power switch (a green button in the base) is switched off if you are going to
shut down the operating room for several days (e.g. for weekends or
holidays).

 Do not place anything under the table top. Otherwise, it may result personal
injury or property damage.

1.4.2 Instructions against Property Damage

 Do not modify the operating table or accessories without authorization of


Nanjing Mindray.

 Make sure the operating table is serviced or maintained by the authorized


personnel only. Otherwise, it may void the warranty.

 Before moving the operating table, make sure the path is clear. Do not
damage the castors or other parts during the movement.

 Before moving the operating table, make sure nothing is placed on the table
top.

 When moving the operating table, be sure to use both hands to


adjust/control the movement. Keep the operating table from colliding with
other things.

1-9
System Overview

 If the table top has descended to a low position, exercise caution when
adjusting the operating table. Keep the table top from colliding with the base
or the ground.

 If the head/leg plate has been positioned downward, exercise caution when
adjusting the operating table. Keep the head/leg plate from colliding with the
base or the ground.

 When sloping the table top or adjusting the leg plates, make sure they do
not collide with the column or the base.

 When adjusting the operating table, make sure the suspended parts (such
as arm boards, leg plates) do not collide with other things inside the
operating room.

 When adjusting the operating table, make sure the cord of the corded hand
control is not jammed by the joints.

 When adjusting the operating table, make sure the accessories or the
surgical drapes are not jammed by the joints.

 When the operating table is not in use, make sure its castors are locked and
table top is in the best rest state (table top slid to the limit of the foot end and
descended to the lowest position).

 Do not touch pins of the connectors identified with the ESD warning
symbol. Connections should not be made to them unless ESD
precautionary procedures are used.

1-10
2 Daily Operations

2.1 Power Supply Systems

The operating table is configured with two independent power supply systems: AC power and
internal battery.

 A battery assembly is provided so that the operating table can function


normally in case the AC power supply is disconnected or not available. It is
recommended that the operating table be run from its internal battery
assembly.

2.1.1 AC Power

 Damaged cables must be replaced immediately.

 To avoid risk of electric shock, the operating table must only be connected
to the supply mains with protective earth.

 Unplug the operating table before moving.

 The operating table is disconnected from the mains by means of the plug.

 Do not position the operating table so that it is difficult to operate the


disconnection device (e.g. plug).

2-1
Daily Operations

2.1.1.1 Connecting the Power Cord


1. Locate the power cord delivered with the operating table.

2. Plug the non-pronged end of the power cord into the power connector (1).

3. Plug the pronged end of the power cord into a power outlet.

4. The AC indicator at the corded hand control is on and green when the operating table is
connected to the mains supply. See chapter 2.4.3 for details.

 When connecting and removing the mains cable, observe the correct order
of the procedure.

1 2 3 4

Figure 2-1 Power switch and power connector

1 Power connector 2 Power switch


3 Corded hand control connector 4 Potential equalization pin

2.1.1.2 Detaching the Power Cord


1. Detach the plug from the socket at the power point.

2. Detach the plug at the operating table.

2-2
Daily Operations

2.1.2 Battery

 A battery assembly is provided so that the operating table can function


normally in case the AC power supply is disconnected or not available. It is
recommended that the operating table be run from its internal battery
assembly.

2.1.2.1 Charging Battery


1. Locate the power cord delivered with the operating table.

2. Plug the non-pronged end of the power cord into the power connector (1).

3. Plug the pronged end of the power cord into a power outlet.

4. The battery indicator at the corded hand control is blinking and green when the battery is
being charged. See chapter 2.4.3 for details.

2-3
Daily Operations

2.2 Power Switch

The power switch is a green button on the operating table base. You can use the button to
turn on/off the operating table.

 Be sure to use the power switch to turn off the operating table in case of an
emergency.

 It is recommended that the operating table be run from its internal battery.

1 2 3 4

Figure 2-2 Power switch and power connector

1 Power connector 2 Power switch


3 Corded hand control connector 4 Potential equalization pin

2-4
Daily Operations

2.3 Potential Equalization

Figure 2-3 Potential equalization pin

 The purpose of the potential equalization pin is to eliminate the potential


difference between electrical devices. Make sure it is connected to a
potential equalization point within the operating room before using the
operating table.

2.3.1 Setting up Potential Equalization


1. Connect the equalization cable to the equalization pin (1) on the operating table.

2. Connect the other end of the potential equalization cable to the operating room’s
potential equalization point.

2-5
Daily Operations

2.4 Corded Hand Control

2.4.1 Connecting and Detaching Corded Hand Control

Connect the corded hand control as instructed below:

1. As Figure 2-4 shows, align the red dot on the plug with that on the port.

2. Insert the plug into the port on the base of the operating table until it clicks.

 When inserting the plug into the port, do not grasp the clip.

Port

Plug

Red dot Red dot

Clip

Figure 2-4 Connecting the corded hand control

2-6
Daily Operations

Detach the corded hand control as instructed below:

1. As Figure 2-5 shows, slide the clip backward.

2. Pull out the plug.

Clip

Figure 2-5 Detaching the corded hand control

2.4.2 Keys

You can use the corded hand control to:

 turn on /off the corded hand control

 raise / lower the table top

 tilt the table top to left / right

 raise / lower the back plate

 obtain the flex /re-flex position

 longitudinally shift the table top toward the head/ foot end (optional)

2-7
Daily Operations

1 8

2 9

10

3 11

4 12

5 13

6 14

7 15

Figure 2-6 Corded hand control

1 AC indicator 2 Power off


3 Longitudinal shift toward foot end 4 Table top down
5 Trendelenburg position (head down) 6 Tilt to left
7 Back plate down 8 Battery indicator
9 Power indicator 10 Power on
11 Longitudinal shift toward head end 12 Table top up
13 Reverse Trendelenburg position (foot 14 Tilt to right
down)
15 Back plate up

You can:

1. turn on /off the corded hand control

 Press to turn on the corded hand control.

 Press to turn off the corded hand control.

2-8
Daily Operations

2. raise / lower the table top

 Press and hold to raise the table top.

 Press and hold to lower the table top.

3. obtain the Trendelenburg / reverse Trendelenburg position

 Press and hold to obtain the Trendelenburg position (head down).

 Press and hold to obtain the reverse Trendelenburg position (foot down).

4. tilt the table top to left / right

 Press and hold to tilt the table top left.

 Press and hold to tilt the table top right.

5. raise / lower the back plate

 Press and hold to raise the back plate.

 Press and hold to lower the back plate.

6. longitudinally shift the table top toward the head/ foot end (optional)

 Press and hold to longitudinally shift the table top toward the foot end.

 Press and hold to longitudinally shift the table top toward the head end.

2-9
Daily Operations

 After adjusting the operating table, be sure to switch off the hand control.

 Each time before using the operating table, check all functions by pressing
every functional key for 2 to 3 seconds. Make sure all the keys can work
normally. Do not use the damaged operating table.

 When adjusting the operating table, make sure the cord of the hand control
is not jammed by the joints.

 After the corded hand control is switched on, the system will run a self-test.
All the indicators will be turned on during the test.

 When the corded hand control has been idle for 90 seconds, it will be
switched off automatically.

2.4.3 Indicator

There are three indicators on the corded hand control: power indicator, AC indicator and
battery indicator. See the table below for details.

Table 2-1 Indicator definitions of corded hand control

Indicator State Definition


Green The operating table is switch on.
Power indicator Off The operating table is switch off.
Green and flashing The operating table may malfunction.
The operating table is connected to
Green
the mains supply.
AC indicator
The operating table is disconnected
Off
from the mains supply.
Green The batteries function normally.
Green (when the
operating table is AC The batteries are sufficiently charged.
Battery indicator
powered)
Green and flashing The batteries are being charged.
Red and flashing The batteries are low.

2-10
Daily Operations

 About ten minutes after the first low battery alarm, the operating table will
power off automatically.

 It takes about 10 hours to fully charge the battery.

2.4.4 Error Indication

When the operating table or the corded hand control is broken, the following states of the
indicators may appear.
 The power indicator (green) is blinking.
 When the operating table is disconnected from mains supply, all the indicators are
blinking.
 When the operating table is AC powered, all the indicators (except the AC indicator) are
blinking.
If the operating table or the corded hand control malfunction, please contact the customer
service department authorized by Nanjing Mindray for help. Unauthorized device servicing is
not allowed.

2-11
Daily Operations

2.4.5 Attaching the Corded Hand Control

 The hand control which is attached to the side rail may slip off the side rail
or catch the cable during table top adjustment.

 It is recommended that the corded hand control be attached into the lug on
the head plate.

As Figure 2-7 shows, attach the bracket (1) to the side rail (2) or the lug (3).

1 3

Figure 2-7 Attaching the corded hand control

2-12
Daily Operations

2.5 Base Cover

You can select the stainless steel or plastic base cover.

2-13
Daily Operations

2.6 Locking/Unlocking the Operating Table

2.6.1 Locking the Operating Table

 Before positioning the patient, make sure the operating table is locked.

1. Hold the operating table with both hands.

2. Press the brake lever down with your foot. 1


3. Push the brake lever until it is held by the
holder (1).

4. Check whether the operating table is


locked.

Figure 2-8 Operating table locked

2.6.2 Unlocking the Operating Table


1. Hold the operating table with both hands.

2. Press the brake lever down with your foot.

3. Pull the brake lever out of the holder (1).

1
Figure 2-9 Operating table unlocked

2-14
Daily Operations

2.7 Table Pad

 Each time before using the pad, check it carefully. Do not use the worn or
damaged pad.

 Liquid can penetrate damaged pad and cause hygienic problems.

 When disinfecting the patient’s skin, make sure the disinfectant does not
accumulate under the patient.

2.7.1 Foam Pad

2.7.1.1 Installing Table Pad


1. Lay the pad on the table.
Velcro strap
2. Make sure that the Velcro strap (loop) on
the pad is fully aligned with that on the
table top (hook).

3. Check whether the pad is reliably


affixed.

Figure 2-10 Velcro strap

2.7.1.2 Removing Table Pad

Grasp the pad with both hands, and then remove it.

Figure 2-11 Removing table pad

2-15
Daily Operations

 Make sure that the Velcro strap on the bottom of the pad is fully aligned with
that on the table top, and they are affixed reliably.

 Worn, loose or wet Velcro cannot secure the pad properly. Do not use the
pad if you find worn, loose or wet signs.

 Be sure to use the recommended cleaning agents and methods to clean the
pad.

 Each time before using the pad, check it carefully. Do not use the worn or
damaged pad.

 When using the pad, be sure to place a sterile surgical drape on it.

 Pad should be stored lying flat and horizontal.

 When removing the pad, be sure to grasp it with both hands.

 Before installing the pad, make sure that the table top is dry.

2-16
Daily Operations

2.8 Head Plate

 When removing/installing the head plate, be sure to grasp it with both


hands. Otherwise, it can fall and cause personal injury and/or property
damage.

 Exercise caution when removing/installing the head plate. Do not pinch


yourself.

 The maximum load of the head plate is 25 kg. Do not use it beyond this limit.

 If accessories are used, make sure the weights of the accessories installed
on the head plate and of the patient’s head add up no more than 25 kg.

 Do not install such devices as arm boards, anesthesia frames and infusion
holders on the head plate. Otherwise, the head plate can move
unexpectedly.

 When using the head plate, be sure to cover it with a sterile surgical drape.

 Each time before using the pad, check it carefully. Do not use the worn or
damaged pad.

 Be sure to use the pad provided by Nanjing Mindray only.

2.8.1 Removing Head Plate


1. Hold the head plate with one hand and then loosen the locking screws (1) with the other
hand.

2. Pull out the head plate.

Figure 2-12 Removing the head plate

2-17
Daily Operations

2.8.2 Installing Head Plate


1. Hold the head plate with both hands, and then insert the two positioning pins into the
table top’s installing sockets.

2. Make sure the pins are pushed all the way in, and tighten the locking screws.

3. Pull the head plate to check whether it has been installed properly.

Socket

Figure 2-13 Installing the head plate

2.8.3 Adjusting Head Plate


1. Hold the head plate with both hands (palms up) and pull the release bracket (1) outward
with fingers.

2. Raise or lower the head plate to the desired position.

3. Release the head plate and the bracket.

4. Pull the head plate to check whether it has been adjusted properly.

Figure 2-14 Adjusting the head plate

2-18
Daily Operations

 When lowering the head plate, be sure to do it slowly and smoothly. Do not
hurt the patient.

 Make sure the head plate is reliably installed before using it.

2-19
Daily Operations

2.9 Leg Plate

 When removing/installing the leg plate, be sure to grasp it with both hands.
Otherwise, it can fall and cause personal injury and/or property damage.

 Exercise caution when removing/installing the leg plate. Do not pinch


yourself.

 Placing the patient improperly can tip over the operating table. Be sure to
place the patient in the right direction. Do not place the patient’s trunk on
the leg plates.

 When using the leg plate, be sure to cover it with a sterile surgical drape.

 The maximum load of the leg plate is 30 kg. Do not use it beyond this limit.

 If accessories are used, make sure the weights of the accessories installed
on the leg plate and of the patient’s leg add up no more than 30 kg.

 When adjusting the patient’s body position, do not reach beneath the table
top or touch the moving parts. Otherwise, you can be pinched.

 Each time before using the pad, check it carefully. Do not use the worn or
damaged pad.

 Be sure to use the pad provided by Nanjing Mindray only.

2.9.1 Removing Leg Plate


1. Hold the leg plate with one hand, and loose the locking button (1) with the other hand.

2. Pull out the leg plate.

Figure 2-15 Removing the leg plate

2-20
Daily Operations

2.9.2 Installing Leg Plate


1. Hold the leg plate with one hand, and loosen the locking button with the other hand.

2. Insert the leg plate pins (3) into the table top’s installing sockets (2). Make sure the pins
are pushed all the way in, and then tighten the locking button (1).

3. Pull the leg plate to check whether it has been installed properly.

Figure 2-16 Installing the leg plate

2.9.3 Adjusting Leg Plate

To move the leg plate up/down:

1. Hold the leg plate with one hand and then release the bracket (1) with the other hand.

2. Raise or lower the leg plate to the desired position.

3. Release the leg plate and the bracket.

Figure 2-17 Moving the leg plate up/down

2-21
Daily Operations

 Before adjusting the leg plate, make sure nothing is under it.

To move the leg plate left/right:

1. Loosen the locking button (1).

2. Adjust the leg plate left/right to the desired position.

3. Tighten the locking button (1).

Figure 2-18 Moving the leg plate left/right

2-22
Daily Operations

2.10 Body Elevator (optional)


1. As figure 2-17 shows, insert the hand crank (1) into the labeled installing hole.

2. Use the hand crank (1) to raise/ lower the body elevator to the desired position.

Body elevator label

Figure 2-19 Adjusting the body elevator

 The body elevator can be operated on either side of the operating table.

2-23
This page is intentionally blank.
3 Cleaning and Disinfection

3.1 General

The product must be cleaned and wipe or spray disinfected after every use.

 Remove the mains plug from the socket before cleaning/disinfection.

 Liquid should never be allowed to enter live parts.

 It is strictly advised to observe the manufacturer instructions regarding how


to use the detergents and disinfectants as well as the valid hospital hygiene
rules.

 Always wear gloves for cleaning and disinfection, otherwise it can cause
infection.

 Be sure to strictly follow the recommended cleaning/disinfecting methods


to clean/disinfect the operating table.

 Do not use the cleaning agents or disinfectants containing alcohol where


such medical devices as electrosurgical units, defibrillators or defibrillator
monitors can be used. Otherwise, it can cause fire and/or explosion
hazards.

 Particles of grime may become encapsulated and lead to the product not
reaching the desired germ-reduction after disinfection. Before disinfection,
the product must be cleaned thoroughly of contamination and encapsulated
particles of grime and then be dried.

 Do not clean/disinfect the operating table mechanically.

 Improper cleaning/disinfection can damage the operating table.

 Use proper amount of the cleaning agent to clean the operating table, and
remove any excessive agent and/or liquid by a dry cloth.

 Perform visual and functional inspections after each cleaning and


disinfection process.

3-1
Cleaning and Disinfection

 Be sure to follow the related national hygiene and disinfection regulations to


carry out cleaning and disinfection procedures.

3.1.1 Recommended Cleaning Agents and Disinfectants


 Mildly alkaline (soap solution)

 Aldehydes

 Quaternary compounds

 Guanidine derivative

 2% alkaline glutaraldehyde (for metal part)

 Do not clean/disinfect the operating table mechanically.

 Do not use the disinfectants containing chlorine or compounds which can


release chlorine to disinfect the metal parts. Long-term use of these
disinfectants may corrode the metal parts, hence compromising safety and
effectiveness of the device. It is recommended that metal parts be
disinfected by 2% alkaline glutaraldehyde.

 Improper cleaning/disinfection can damage the operating table.

 Do not spray the cleaning agent/disinfectant directly into the joints or gaps.

 Do not use high-pressure cleaning devices.

 Do not use scouring agents.

 Do not use water containing metal particles, any metal tools (such as wire
brushes or steel wool), or products containing hydrochloric acid to clean
the operating table.

3.1.2 Forbidden Cleaning Agents and Disinfectants


 Disinfectants containing alcohol (e. g. hand disinfectants)

 Disinfectants containing chlorine or compounds which can release chlorine (not suitable
for metal parts)

 Halogenides and dehalogenating compounds

 Products that may scratch the surface (e. g. scouring agents, wire brushes, wire wool)

 Standard commercial solvents (e. g. benzene, thinner)

 Products containing hydrochloric acid

3-2
Cleaning and Disinfection

3.2 Cleaning

3.2.1 Preparations
1. Put operating table into the horizontal position.

2. Raise the operating table up to the highest position.

3. Use surgical drapes to cover the operating table when not in use.

3.2.2 Cleaning Procedure


1. Turn off the power.

2. Use a piece of lint-free clean cloth to wipe off the dust.

3. Use a piece of lint-free clean cloth dipped into the chosen detergent to clean the surface
of the operating table.

4. Use a piece of lint-free clean cloth dipped into the clean water to wipe the detergent off
the surface.

5. Use a piece of dry clean cloth to wipe the surface.

 Exercise caution for the gaps when cleaning or disinfecting the table top.
Otherwise, you can be pinched.

 Be sure to disinfect the product after every cleaning.

 In the event of very dirty product surfaces, carry out an additional


disinfection procedure before cleaning the product.

 Use only all-purpose cleaners which are slightly alkaline (soap solution) and
contain tensides and phosphates as the active cleaning agents. In the event
of heavily contaminated surfaces, use concentrated multi-purpose
detergent.

 Improper cleaning can cause property damage! Residues of physiological


saline solutions (e. g. sodium chloride) can attack the surfaces of the
product. Remove residues of physiological saline solutions with a cloth
dipped in clean water. Then dry the product with a dry, lint free cloth.

 Do not spray cleaning agent directly into the joints or gaps and never use a

3-3
Cleaning and Disinfection

high-pressure cleaning unit!

 Cleaning causes lubricants to be flushed out of the product. Re-lubricate the


product according to the lubrication instructions.

3-4
Cleaning and Disinfection

3.3 Disinfection

3.3.1 General

 Exercise caution for the gaps when cleaning or disinfecting the table top.
Otherwise, you can be pinched.

 Agents containing alcohol can form explosive vapor mixtures and ignite
where high-frequency equipment is being used. Do not use agents
containing alcohol where high-frequency equipment is being used.

 Material damage due to excessive exposure times! Exceeding the specified


exposure time of the disinfectant may damage the surfaces. Remove
disinfectant residues with a cloth dipped in clean water. Then dry the
product with a dry, lint free cloth.

3.3.2 Disinfection Procedure


1. Turn off the power.

2. Clean the operating table. See chapter 3.2 for details.

3. Use a piece of lint-free clean cloth dipped into the chosen disinfectant to disinfect the
surface of the operating table.

4. Use a piece of lint-free clean cloth dipped into the clean water to wipe the disinfectant off
the surface.

5. Use a piece of dry clean cloth to wipe the surface.

3-5
Cleaning and Disinfection

3.4 Table Pad

 Each time before using the pad, check it carefully. Do not use the worn or
damaged pad and replace damaged pad immediately.

 Any worn or damaged pad should be replaced immediately.

 Moisture or liquid can penetrate the damaged pad and hygiene


requirements are then no longer satisfied.

 Do not clean/disinfect the pad mechanically.

 Do not use the cleaning agents or disinfectants containing alcohol.

 Improper cleaning and disinfection can cause property damage.

 The adhesive force of the Velcro strap may be compromised due to


contamination. It is recommended a plastic soft brush or a plastic comb
used to remove the contamination.

 Pad should be stored lying flat and horizontal.

 When removing the pad, be sure to grasp it with both hands.

 Before installing the pad, make sure that the table top is dry.

 Do not use the disinfectant containing alcohol.

 Do not use the disinfectant containing chlorine or compounds which can


release chlorine.

3.4.1 Cleaning
1. Remove the pad.

2. Clean the pad with a wet cloth.

3. Wipe the pad dry.

4. Before installing the pad, make sure the pad and its Velcro straps are dry.

3-6
Cleaning and Disinfection

3.4.2 Disinfection

Do not use the disinfectants containing alcohol to clean the pad. Disinfectants containing
aldehydes are recommended.

3-7
Cleaning and Disinfection

3.5 Swivel Castor


1. Use a lint-free cloth dipped into a surface disinfectant to wipe the swivel castors.

2. Use a lint-free cloth dipped into the clean water to clean the castors.

3. Use a lint-free cloth to wipe the castors dry.

4. Do not collide with the base or column when cleaning and disinfecting the castors under
the base.

3-8
4 Maintenance

4.1 Inspections and Maintenance

4.1.1 Inspections

Perform the following inspections each time before using the operating table, or at least once
a day.

1. Has the operating table been properly cleaned and/or disinfected?

2. Have the castors been properly locked?

3. Are there any cracks on the pad?

4. Has the pad been firmly fixed on the table top?

5. Are there any damaged mechanical parts?

6. Are there any damaged cables?

7. Are all table-top movements functional?

4.1.2 Maintenance
1. Complete electrical / safety inspections should be conducted every year by personnel
authorized by Nanjing Mindray.

2. It is recommended that the operating table be serviced by professionals every year.

3. It is recommended that the hydraulic oil be replaced by professionals every 5 years.

 The operating table may be used only when properly lubricated and fully
functional. It is recommended that lubricate the operating table every year
by personnel authorized by Nanjing Mindray.

4-1
This page is intentionally blank.
5 Troubleshooting

 The chapter is meant to help you solve common problems only. In case you
encounter problems not included in this chapter or following the introduced
methods cannot solve the problem, contact the customer service
department authorized by Nanjing Mindray for help. Unauthorized device
servicing is not allowed.

 Device servicing is to be performed by personnel authorized by Nanjing


Mindray only. Unauthorized device servicing can cause personal injury
and/or property damage.

 Device servicing should be strictly based on technical data supplied by


Nanjing Mindray. If you are in need of more technical data, contact the
customer service department authorized by Nanjing Mindray or your local
distributor.

Error Cause Solution


1. Check whether the
mains supply is
1. The battery is dead and
connected.
the mains supply is not
2. Check whether the
The operating table cannot connected.
battery is sufficiently
be turned on. 2. The power switch on
charged.
the base of the
3. Check whether the
operating table is off.
power switch is on.

The battery indicator on the


corded hand control or the Connect the operating table
The battery is low.
override panel is blinking to the mains supply.
(red).

5-1
Troubleshooting

Error Cause Solution


1. The power indicator
(green) is blinking.
2. When the operating
table is disconnected
from mains supply, all
the indicators are Contact the customer
blinking. service department
The operating table
3. When the operating authorized by Nanjing
malfunctions.
table is AC powered, all Mindray or your local
the indicators (except distributor.
the AC indicator) are
blinking.
4. The operating table
beeps (three short
tones).

5-2
6 Clamp

6.1 Intended Use

The clamp is intended to serve as an adaptor to mount operating table accessories.


Four types of clamps are available:

 Heavy radial clamp

 Light radial clamp

 Heavy quadrate clamp

 Light quadrate clamp

 There are totally 4 types of clamps available. Use the clamp that exactly
matches your accessories. Otherwise, it can cause personal injury and/or
property damage.

 The clamps are to be used with Nanjing Mindray’s accessories only. Do not
use them on other accessories.

6-1
Clamp

6.2 Heavy Radial Clamp

6.2.1 Specifications
1. Height: 66mm

2. Length: 125mm

3. Width: 121mm

4. Permissible rod diameter: Φ16mm

5. Weight: 0.9kg

6. Suitable side rail: 25×10mm

6.2.2 Components

3
2

Figure 6-1 Heavy radial clamp

1 Clamp housing 2 Locking screw


3 Locking handle

6.2.3 Installation and Use

6.2.3.1 Inspection before Use

The clamp is maintenance-free. However, wear due to use and aging can compromise its
functionality and safety. Check the clamp carefully each time before use. Do not use the clamp
if you see any sign of wear or damage.

6-2
Clamp

 Be sure to check the clamp each time before use. Do not use worn or
damaged clamps.

6.2.3.2 Installation and Use


1. Slide the clamp housing onto the side rail of the operating table.

2. Tighten the locking screw to lock the clamp.

3. Insert the accessory into the opening of the clamp.

4. Tighten the locking handle to lock the accessory.

5. Make sure both the clamp and the accessory are reliably installed.

 Make sure the clamp is tightly locked on the side rail and positioned upright.
Otherwise, the accessory can fall and cause personal injury and/or property
damage.

 Make sure both the locking screw and the locking handle are properly
tightened. Otherwise, the accessory can fall and cause personal injury
and/or property damage.

6-3
Clamp

6.3 Light Radial Clamp

6.3.1 Specifications
1. Height: 58mm

2. Length: 115mm

3. Width: 100mm

4. Permissible rod diameter: Φ18mm, Φ16mm or Φ12mm

5. Weight: 0.8kg

6. Suitable side rail: 25×10mm

6.3.2 Components

Figure 6-2 Light radial clamp

1 Clamp housing 2 Locking handle

6-4
Clamp

6.3.3 Installation and Use

6.3.3.1 Inspection before Use

The clamp is maintenance-free. However, wear due to use and aging can compromise its
functionality and safety. Check the clamp carefully each time before use. Do not use the clamp
if you see any sign of wear or damage.

 Be sure to check the clamp each time before use. Do not use worn or
damaged clamps.

6.3.3.2 Installation and Use


1. Slide the clamp housing onto the side rail of the operating table.

2. Insert the accessory into the opening of the clamp.

3. Tighten the locking handle to lock the accessory.

4. Make sure both the clamp and the accessory are reliably installed.

 Make sure the clamp is tightly locked on the side rail and positioned upright.
Otherwise, the accessory can fall and cause personal injury and/or property
damage.

 Make sure the locking handle is properly tightened. Otherwise, the


accessory can fall and cause personal injury and/or property damage.

 Before removing the accessory, be sure to hold the clamp. Otherwise, it can
fall and cause personal injury and/or property damage.

6-5
Clamp

6.4 Heavy Quadrate Clamp

6.4.1 Specifications
1. Height: 48mm

2. Length: 89mm

3. Width: 85mm

4. Permissible rod diameter: 20×20mm

5. Weight: 0.6kg

6. Suitable side rail: 25×10mm

6.4.2 Components

Figure 6-3 Heavy quadrate clamp

1 Clamp housing 2 Locking handle

6.4.3 Installation and Use

6.4.3.1 Inspection before Use

The clamp is maintenance-free. However, wear due to use and aging can compromise its
functionality and safety. Check the clamp carefully each time before use. Do not use the clamp
if you see any sign of wear or damage.

6-6
Clamp

 Be sure to check the clamp each time before use. Do not use worn or
damaged clamps.

6.4.3.2 Installation and Use


1. Slide the clamp housing onto the side rail of the operating table.

2. Insert the accessory into the opening of the clamp.

3. Tighten the locking handle to lock the accessory.

4. Make sure both the clamp and the accessory are reliably installed.

 Make sure the clamp is tightly locked on the side rail and positioned upright.
Otherwise, the accessory can fall and cause personal injury and/or property
damage.

 Make sure both the locking screw and the locking handle are properly
tightened. Otherwise, the accessory can fall and cause personal injury
and/or property damage.

6-7
Clamp

6.5 Light Quadrate Clamp

6.5.1 Specifications
1. Height: 48mm

2. Length: 91mm

3. Width: 80mm

4. Permissible section: 6×25mm or Φ12mm

5. Weight: 0.45kg

6. Suitable side rail: 25×10mm

6.5.2 Components
1

Figure 6-4 Light quadrate clamp

1 Clamp housing 2 Locking handle

6.5.3 Installation and Use

6.5.3.1 Inspection before Use

The clamp is maintenance-free. However, wear due to use and aging can compromise its
functionality and safety. Check the clamp carefully each time before use. Do not use the clamp
if you see any sign of wear or damage.

 Be sure to check the clamp each time before use. Do not use worn or
damaged clamps.

6-8
Clamp

6.5.3.2 Installation and Use


1. As Figure 6-5 shows, slide the clamp housing onto the side rail of the operating table.

2. Insert the accessory into the opening of the clamp.

3. Tighten the locking handle to lock the accessory.

4. Make sure both the clamp and the accessory are reliably installed.

Upward

Figure 6-5 Correctly installing the clamp

 Make sure the clamp is tightly locked on the side rail and positioned upright.
Otherwise, the accessory can fall and cause personal injury and/or property
damage.

 Make sure the locking handle is properly tightened. Otherwise, the


accessory can fall and cause personal injury and/or property damage.

 Be sure to correctly install the clamp, as Figure 6-5 shows. Otherwise, it can
fall and cause personal injury and/or property damage.

 Before removing the accessory, be sure to hold the clamp. Otherwise, it can
fall and cause personal injury and/or property damage.

6-9
Clamp

6.6 Cleaning and Disinfection

6.6.1 Cleaning

All-purpose cleaning agents are recommended.

 Use the mildly alkaline cleaning agent (soap solution) to clean the clamp.

 All-purpose cleaning agents are those containing tensides and phosphates


as the active cleaning ingredients.

 Use proper amount of the cleaning agent to clean the clamp, and remove
any excessive agent and/or liquid by a dry cloth.

If the surface is extremely soiled,

1. Use the concentrated cleaning agent to clean the clamp.

2. Rinse the clamp with clean water.

3. Use a dry cloth to wipe the clamp.

 Be sure to only use the recommended agents and methods to clean the
clamp.

 Do not use high-pressure cleaning devices.

 Do not use scouring agents.

 Do not use water containing metal particles, any metal tools (such as wire
brushes or steel wool), or products containing hydrochloric acid.

6-10
Clamp

6.6.2 Disinfection

The following disinfectants are recommended:

 Aldehydes

 Quaternary compounds

 Guanidine derivatives

 Do not use the cleaning agents or disinfectants containing alcohol where


such medical devices as electrosurgical units, defibrillators or defibrillator
monitors can be used. Otherwise, it can cause fire and/or explosion
hazards.

 Do not use the disinfectants containing alcohol.

 Do not use the disinfectants containing chlorine or compounds which can


release chlorine to disinfect the metal parts. Long-term use of these
disinfectants may corrode the metal parts, hence compromising safety and
effectiveness of the device. It is recommended that metal parts be
disinfected by 2% alkaline glutaraldehyde.

 Be sure to only use the recommended disinfectants and methods.

 Do not use scouring agents.

 Do not use water containing metal particles, any metal tools (such as wire
brushes or steel wool), or products containing hydrochloric acid.

 Do not disinfect the clamp mechanically.

6-11
This page is intentionally blank.
7 Anesthesia Frame

7.1 Intended Use

The anesthesia frame is intended to hold the surgical sheet used for sterile cover of the
patient.
Two types of anesthesia frames are available:

 Heavy anesthesia frame

 Light anesthesia frame

 The anesthesia frame is part of the operating table system. Familiarize


yourself with operation of the operating table before installing and using it.

 The anesthesia frame is only to be used with the operating tables and the
clamps made by Nanjing Mindray. Do not use it with other products.
Otherwise, it can cause personal injury and/or property damage.

7-1
Anesthesia Frame

7.2 Heavy Anesthesia Frame

7.2.1 Specifications
1. Height: 890mm

2. Adjustment range: 470 - 890mm

3. Width: 650mm (elongation tubes not included)

4. Diameter: Φ16mm

5. Length of the elongation tube: 300mm

6. Suitable clamp: heavy or light radial clamp

7. Weight: 2.7kg

7.2.2 Components

Figure 7-1 Heavy anesthesia frame

1 Vertical pole 2 Horizontal pole

3 Elongation tubes

7-2
Anesthesia Frame

7.2.3 Installation and Use

7.2.3.1 Inspection before Use

The anesthesia frame is maintenance-free. However, wear due to use and aging can
compromise its functionality and safety. Check it carefully each time before use. Do not use it if
you see any sign of wear or damage.

 Be sure to check the anesthesia frame each time before use. Do not use the
worn or damaged anesthesia frame.

7.2.3.2 Installation and Use


1. Slide the clamp housing onto the side rail of the operating table.

2. Tighten the locking screw to lock the clamp.

3. Insert the vertical pole of the anesthesia frame into the opening of the clamp.

4. Adjust the vertical pole to a suitable height.

5. Tighten the locking handle to lock the anesthesia frame.

6. Hang the surgical sheet on the horizontal pole of the anesthesia frame.

7. Make sure both the clamp and the anesthesia frame are reliably installed.

 Only the radial clamps match the vertical pole of the heavy anesthesia
frame. Do not use other clamps. Otherwise, it can cause personal injury
and/or property damage.

 Make sure the clamp is tightly locked on the side rail and positioned upright.
Otherwise, the anesthesia frame can fall and cause personal injury and/or
property damage.

 Make sure the anesthesia frame is tightly fixed by the locking handle and
positioned upright. Otherwise, the anesthesia frame can fall and cause
personal injury and/or property damage.

7-3
Anesthesia Frame

7.3 Light Anesthesia Frame

7.3.1 Specifications
1. Height: 890mm

2. Width: 650mm

3. Diameter: Φ12mm

4. Suitable clamp: light quadrate clamp

5. Weight: 1.5kg

7.3.2 Components

Figure 7-2 Light anesthesia frame

1 Vertical pole 2 Horizontal pole

7.3.3 Installation and Use

7.3.3.1 Inspection before Use

The anesthesia frame is maintenance-free. However, wear due to use and aging can
compromise its functionality and safety. Check the clamp carefully each time before use. Do
not use the clamp if you see any sign of wear or damage.

7-4
Anesthesia Frame

 Be sure to check the anesthesia frame each time before use. Do not use the
worn or damaged anesthesia frame.

7.3.3.2 Installation and Use


1. Slide the clamp housing onto the side rail of the operating table.

2. Insert the vertical pole of the anesthesia frame into the opening of the clamp.

3. Adjust the vertical pole to a suitable height.

4. Tighten the locking handle to lock the accessory.

5. Hang the surgical sheet on the horizontal pole of the anesthesia frame.

6. Make sure both the clamp and the anesthesia frame are reliably installed.

 Only the light quadrate clamps match the vertical pole of the light
anesthesia frame. Do not use other clamps. Otherwise, it can cause
personal injury and/or property damage.

 Make sure the clamp is tightly locked on the side rail and positioned upright.
Otherwise, the anesthesia frame can fall and cause personal injury and/or
property damage.

 Make sure the anesthesia frame is tightly fixed by the locking handle and
positioned upright. Otherwise, the anesthesia frame can fall and cause
personal injury and/or property damage.

7-5
Anesthesia Frame

7.4 Cleaning and Disinfection

7.4.1 Cleaning

All-purpose cleaning agents are recommended.

 Use the mildly alkaline cleaning agent (soap solution) to clean the
anesthesia frame.

 All-purpose cleaning agents are those containing tensides and phosphates


as the active cleaning ingredients.

 Use proper amount of the cleaning agent to clean the anesthesia frame, and
remove any excessive agent and/or liquid by a dry cloth.

If the surface is extremely soiled,

1. Use the concentrated cleaning agent to clean the anesthesia frame.

2. Rinse the anesthesia frame with clean water.

3. Use a dry cloth to wipe the anesthesia frame.

 Be sure to only use the recommended agents and methods to clean the
anesthesia frame.

 Do not use high-pressure cleaning devices.

 Do not use scouring agents.

 Do not use water containing metal particles, any metal tools (such as wire
brushes or steel wool), or products containing hydrochloric acid.

7.4.2 Disinfection

The following disinfectants are recommended:

 Aldehydes

 Quaternary compounds

 Guanidine derivatives

7-6
Anesthesia Frame

 Do not use the cleaning agents or disinfectants containing alcohol where


such medical devices as electrosurgical units, defibrillators or defibrillator
monitors can be used. Otherwise, it can cause fire and/or explosion
hazards.

 Do not use the disinfectants containing alcohol.

 Do not use the disinfectants containing chlorine or compounds which can


release chlorine to disinfect the metal parts. Long-term use of these
disinfectants may corrode the metal parts, hence compromising safety and
effectiveness of the device. It is recommended that metal parts be
disinfected by 2% alkaline glutaraldehyde.

 Be sure to only use the recommended disinfectants and methods.

 Do not use scouring agents.

 Do not use water containing metal particles, any metal tools (such as wire
brushes or steel wool), or products containing hydrochloric acid.

 Do not disinfect the anesthesia frame mechanically.

7-7
This page is intentionally blank.
8 Arm Board

8.1 Intended Use

The arm board is intended to position the patient’s arm (one for each arm) during the surgery.
Two types of arm boards are available:

 Heavy arm board

 Light arm board

 The arm board is part of the operating table system. Familiarize yourself
with operation of the operating table before installing and using it.

 The arm board is only to be used with the operating tables and the clamps
made by Nanjing Mindray. Do not use it with other products. Otherwise, it
can cause personal injury and/or property damage.

8-1
Arm Board

8.2 Heavy Arm Board

8.2.1 Specifications
1. Length: 600mm

2. Width: 170mm

3. Height: 210mm

4. Height adjustment range: 75mm

5. Pole diameter: Φ16mm

6. Suitable clamp: heavy or light radial clamp

7. Weight: 2.1kg

8. Maximum load: 8.5kg

9. Lateral adjustment range: 180°

10. Vertical adjustment range: 30°up, 35°down

8.2.2 Components

2
1
4

Figure 8-1 Heavy arm board

1 Arm board 2 Release bracket


3 Arm board pad 4 Fastening strap

8-2
Arm Board

8.2.3 Installation and Use

8.2.3.1 Inspection before Use

The arm board is maintenance-free. However, wear due to use and aging can compromise its
functionality and safety. Check it carefully each time before use. Do not use it if you see any
sign of wear or damage.

 Be sure to check the arm board each time before use. Do not use the worn
or damaged arm board.

8.2.3.2 Installation and Use


1. Slide the clamp housing onto the side rail of the operating table.

2. Tighten the locking screw to lock the clamp.

3. Insert the vertical pole of the arm board into the opening of the clamp.

4. Adjust the vertical pole to a suitable height.

5. Tighten the locking handle to lock the arm board.

6. Adjust the arm board vertically and/or laterally to a suitable position.

7. Secure the patient’s arm with the fastening strap.

8. Make sure both the clamp and the arm board are reliably installed.

 Only the radial clamps match the vertical pole of the heavy arm board. Do
not use other clamps. Otherwise, it can cause personal injury and/or
property damage.

 Make sure the clamp is tightly locked on the side rail and positioned upright.
Otherwise, the arm board can fall and cause personal injury and/or property
damage.

 Make sure the arm board is tightly fixed by the locking handle and
positioned upright. Otherwise, the arm board can fall and cause personal
injury and/or property damage.

 The maximum load of the arm board is 8.5 kg. Do not use it beyond this
limit.

 Do not lean on the arm board during the surgery. Otherwise, the patient’s

8-3
Arm Board

arm can be permanently damaged.

 Be sure to regularly check the position of the patient’s arm during the
surgery.

 It is recommended the arm board be positioned parallel to the table top.


Otherwise, collision hazard is possible.

 When using the arm board, be sure to cover it with a surgical drape.

8-4
Arm Board

8.3 Light Arm Board

8.3.1 Specifications
1. Length: 550mm

2. Width: 140mm

3. Height: 140mm

4. Weight: 2.1kg

5. Lateral adjustment range: 180°

6. Maximum load: 8.5kg

8.3.2 Components
6

1 5
4

3
2

Figure 8-2 Light arm board

1 Clamp 2 Locking handle


3 Fastening strap 4 Adjustment lever
5 Arm board 6 Arm board pad

8-5
Arm Board

8.3.3 Installation and Use

8.3.3.1 Inspection before Use

The arm board is maintenance-free. However, wear due to use and aging can compromise its
functionality and safety. Check the clamp carefully each time before use. Do not use the
clamp if you see any sign of wear or damage.

 Be sure to check the arm board each time before use. Do not use worn or
damaged arm boards.

8.3.3.2 Installation and Use


1. Hold the arm board with one hand.

2. Hold the clamp with the other hand.

3. Slide the clamp onto the side rail of the operating table and release the clamp.

4. Pull the adjustment lever and move the arm board to the desired position.

5. Secure the patient’s arm with the fastening strap.

6. Make sure the arm board is reliably installed.

 Make sure the clamp is tightly locked on the side rail and positioned upright.
Otherwise, the arm board can fall and cause personal injury and/or property
damage.

 The maximum load of the arm board is 8.5 kg. Do not use it beyond this
limit.

 Do not lean on the arm board during the surgery. Otherwise, the patient’s
arm can be permanently damaged.

 Be sure to regularly check the position of the patient’s arm during the
surgery.

 It is recommended the arm board be positioned parallel to the table top.


Otherwise, collision hazard is possible.

 When using the arm board, be sure to cover it with a surgical drape.

8-6
Arm Board

8.4 Cleaning and Disinfection

8.4.1 Cleaning

All-purpose cleaning agents are recommended.

 Use the mildly alkaline cleaning agent (soap solution) to clean the arm
board.

 All-purpose cleaning agents are those containing tensides and phosphates


as the active cleaning ingredients.

 Use proper amount of the cleaning agent to clean the arm board, and
remove any excessive agent and/or liquid by a dry cloth.

If the surface is extremely soiled,

1. Use the concentrated cleaning agent to clean the arm board.

2. Rinse the arm board with clean water.

3. Use a dry cloth to wipe the arm board.

 Be sure to only use the recommended agents and methods to clean the arm
board.

 Do not use high-pressure cleaning devices.

 Do not use scouring agents.

 Do not use water containing metal particles, any metal tools (such as wire
brushes or steel wool), or products containing hydrochloric acid.

8.4.2 Disinfection

The following disinfectants are recommended:

 Aldehydes

 Quaternary compounds

 Guanidine derivatives

8-7
Arm Board

 Do not use the cleaning agents or disinfectants containing alcohol where


such medical devices as electrosurgical units, defibrillators or defibrillator
monitors can be used. Otherwise, fire or explosion hazards are possible.

 Do not use the disinfectants containing alcohol.

 Do not use the disinfectants containing chlorine or compounds which can


release chlorine to disinfect the metal parts. Long-term use of these
disinfectants may corrode the metal parts, hence compromising safety and
effectiveness of the device. It is recommended that metal parts be
disinfected by 2% alkaline glutaraldehyde.

 Be sure to only use the recommended disinfectants and methods.

 Do not use scouring agents.

 Do not use water containing metal particles, any metal tools (such as wire
brushes or steel wool), or products containing hydrochloric acid.

 Do not disinfect the arm board mechanically.

8.4.3 Cleaning/Disinfecting Pad

 Liquid can penetrate damaged pad and cause hygienic problems.

 When disinfecting the patient’s skin, make sure the disinfectant does not
accumulate under the patient.

 Do not use the worn or damaged pad.

 Do not clean/disinfect the pad mechanically.

 Do not use the disinfectants containing alcohol.

 Do not use the disinfectants containing chlorine or compounds which can


release chlorine.

8-8
Arm Board

 The pad should be stored lying flat and horizontal.

 Before installing the pad, make sure that the arm board is dry.

8.4.3.1 Cleaning
1. Remove the pad.

2. Clean the pad with a wet cloth.

3. Wipe the pad dry.

4. Before installing the pad, make sure the pad and its Velcro strap are dry.

8.4.4 Cleaning Fastening Strap

Close the strap, and then wash, dry-clean, and iron it. After washing the Velcro strap, dry it
properly.

8-9
This page is intentionally blank.
9 Appendices

A Technical Specifications

A.1 Classification

A.1.1 According to the Type of Protection against Electrical Shock

Class I, internal electrical power source.

 The operating table depends on the protective earth system to protect


against electrical shock. Before installing it, check and make sure that the
protective earth system in the operating room is reliable and safe.

A.1.2 According to Degree of Protection against Electrical Shock

Applied part is classified as type B.

A.1.3 According to Mode of Operation

Intermittent: 5 minutes on /10 minutes off.

A.1.4 According to the Protection against Harmful Ingress of Water or


Particulate Matter

Operating table: IPX4

A.1.5 According to the Degree of Safety of Application in the Presence


of a Flammable Anesthetic Mixture with Air or with Oxygen or with
Nitrous Oxide

The operating table cannot be used in the presence of a flammable anesthetic mixture with
air or with oxygen or with nitrous oxide.

9-1
Appendices

A.2 Environment

A.2.1 AC power
1. 100-240V~ 50/60Hz 4.0-1.6A (400VA)

A.2.2 Battery
1. Voltage: 24V DC (12V×2)

2. Time to fully charge the battery: about 10h

 Fully charged batteries can run the operating table for about one week.

 About ten minutes after the first low battery alarm, the operating table will
power off automatically.

 We recommend recharging the batteries overnight, but at least every 2 days,


even if low battery alarm of the rechargeable batteries has not been
indicated yet. Regular recharging of the batteries will not only ensure
sufficient battery power available for the operation programme, it will also
serve to prolong the useful life of the rechargeable batteries.

 Do not use the damaged battery. If the battery is dead, contact the customer
service department authorized by Nanjing Mindray or your local distributor.

 If the operating time of the battery (fully charged) is noticeably shorten,


contact the customer service department authorized by Nanjing Mindray or
your local distributor.

A.2.3 Fuse

250V T6.3AH

A.2.4 Operating Environment


1. Temperature: 5°C to 40°C

2. Humidity: 15% to 95%, non-condensing

3. Atmospheric pressure: 70kPa to 106kPa

9-2
Appendices

A.2.5 Storage and Transportation


1. Temperature: -40°C to 60°C

2. Humidity: 10% to 95%, non-condensing

3. Atmospheric pressure: 50kPa to 106kPa

 During transportation, make sure that the operating table is well protected
from rain, snow or mechanical collision.

 The operating table should be installed in a room that is dry, draughty and
without caustic gas.

A.2.6 Environmental Protection


1. Packaging: The packaging is made of materials compatible with the environment. The
packaging should be disposed of in compliance with local governmental or hospital
regulations.

2. Batteries: Batteries can be turned in to your local disposal system for proper handling.

9-3
Appendices

A.3 Load
1. Maximum load: 185kg

2. When the patient positioning at an overall load over 135kg, please observe the following
functional restrictions:

1) Do not shift the table top to the head end.

9-4
Appendices

A.4 Specifications
1. Table top Trendelenburg/reverse Trendelenburg: 26°±5°

26° 26°

2. Table top tilt left/right: 21°±5°

21° 21°

9-5
Appendices

3. Back plate up/down: up 80°±10°, down 40°±10°

80°

40°

4. Leg plate up/down: up 20°±5°, down no less than 90°

Leg plate left/right: left 90°, right 90°

90°
20°

90°
90°

9-6
Appendices

5. Head plate up/down: up 45°±5°, down 90°±5°

45°

90°

6. Maximum table-top height: 1030mm ± 50mm

Minimum table-top height: 680 mm ± 50mm

350mm±15mm

9-7
Appendices

7. Table top longitudinal shift: 300mm ± 10mm

300mm

8. Body elevator up: 120mm ± 10mm

120mm

9-8
Appendices

A.5 Accessories

Item Name
1 Pad
2 Back plate pad
3 Head plate pad
4 Leg plate pad
5 Head plate
6 Leg plate
7 Corded hand control
8 Light Ana. Frame
9 Heavy Ana. Frame
10 Universal adaptor
11 Head rest,HyHead-1
12 Head rest,HyHead-2
13 Ophthalmic operating plate
14 Light arm board
15 Heavy arm board
16 Suspended arm strap
17 Wristlet
18 Arm operating table
19 Double arm board
20 Arm board for lateral position
21 clamp
22 shoulder support
23 Light shoulder support
24 Heavy body support
25 Light body support
26 Heavy leg support
27 Light leg support
28 Leg holder with loops
29 Stirrups
30 Thigh holder
31 Shank holder
32 Foot plate
33 Pad for intervertebral disc operations
34 Body strap
35 Cassette fixer
36 Infusion holder
37 Drainage bowl
38 Accessory cart

9-9
Appendices

Item Name
39 Mayo instrument tray
40 Instrument tray
41 Hand grips
42 Table width extender
43 Lead-acid battery
44 Ortho extension
45 Arthroscopic leg holder
46 Upper arm support
47 Meniscus positioning device
48 Humerus countertraction post
49 Axilla countertraction post
50 Elbow countertraction post
51 Weinberger hand traction device
52 Forearm extension device
53 Upper arm extension device
54 Head rest with guiding roller
55 Side rail extension
56 Leg restraint cuff, thigh
57 Leg restraint cuff, shank
58 Prone position pillow
59 Head ring
60 Horseshoe head ring,small
61 Universal supine pad
62 Ophthalmic head pad
63 Pillow for supine position
64 Universal head pad
65 Universal arm board pad
66 Elbow protection strap
67 Wrist protector
68 Lateral positioner
69 Pad for intervertebral disc
70 Chest-hipbone pad
71 Pad for countertraction post
72 Body strap
73 Arm/leg pad
74 Heel pad,one piece
75 Universal square pad
76 Ankle protection strap
77 Table pads
78 Headrest system
79 Skull clamp
80 Swivel adaptor

9-10
Appendices

Item Name
81 Adjustable base unit
82 Skull pins
83 Crossbar adaptor
84 Multi-function foot plate
85 Arm traction device
86 Struma position pillow
87 Universal hip pad
88 Gel body roll,
89 Hip pad with special bubble
90 Fracture table post pads
91 Ortho extension cart

 If you want to know more information, please see the accessories brochure
for details.

9-11
Appendices

A.6 EMC

The device meets the requirements of IEC 60601-1-2: 2014.

 Use of accessories, transducers and cables other than those specified or


provided by the manufacturer of this device could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
device and result in improper operation.
 Use of this device adjacent to or stacked with other device should be
avoided because it could result in improper operation. If such use is
necessary, this device and the other device should be observed to verify
that they are operating normally.
 Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of the UniBase 30 operating table, including cables
specified by the manufacturer. Otherwise, degradation of the performance
of this device could result.
 The non-ME EQUIPMENT (e.g. ITE) that is a part of an ME SYSTEM may be
disrupted by the electromagnetic interference of nearby equipment. It may
be necessary to take mitigation measures, such as re-orienting or relocating
the non-ME EQUIPMENT or shielding the location.
 This device is intended for use in professional healthcare facility
environment only. If it is used in special environment, such as magnetic
resonance imaging environment, the equipment/system may be disrupted
by the operation of nearby equipment.

9-12
Appendices

Table 9-1 Guidance and Declaration-Electromagnetic Emissions

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.
Emissions test Compliance Electromagnetic environment-guidance
Conducted and The device uses RF energy only for its internal
radiated RF function. Therefore, its RF emissions are very low
Group 1
EMISSIONS and are not likely to cause any interference in
CISPR 11 nearby electronic device.

Conducted and
radiated RF
Class A
EMISSIONS
The device is suitable for use in all establishments
CISPR 11
other than domestic and those directly connected
Harmonic distortion Not to the public low-voltage power supply network
IEC 61000-3-2 applicable that supplies buildings used for domestic
Voltage fluctuations purposes.
Not
and flicker
applicable
IEC 61000-3-3

 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 affect this device even though they meet the
requirements of CISPR.
 The EMISSIONS characteristics of this device make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this device
might not offer adequate protection to radio-frequency communication
services. The user might need to take mitigation measures, such as
relocating or re-orienting the device.
 If the essential performance is lost or degraded, it may be necessary to take
mitigation measures, such as re-orienting or relocating the ME EQUIPMENT
or ME SYSTEM or shielding the location or stopping using the device and
contact the service personnel

9-13
Appendices

If the device 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: realize the normal movement is recognized as the essential
performance.

Table 9-2 Guidance and Declaration-Electromagnetic Immunity

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.
IEC60601 test Electromagnetic
Immunity test Compliance level
level environment-guidance
Floors should be wood,
concrete or ceramic tile. If
Electrostatic
±8 kV contact ±8 kV contact floors are covered with
discharge (ESD)
±15 kV air ±15 kV air synthetic material, the
IEC 61000-4-2
relative humidity should
be at least 30%.
±2 kV for power ±2 kV for power
supply lines supply lines
Electrical fast
±1 kV for ±1 kV for
transient/burst
input/output lines input/output lines Mains power quality
IEC 61000-4-4
(length greater than (length greater than should be that of a typical
3 m) 3 m) commercial or hospital
±1 kV line(s) to ±1 kV line(s) to environment.
Surge line(s) line(s)
IEC 61000-4-5 ±2 kV line(s) to ±2 kV line(s) to
earth earth
Mains power quality
should be that of a typical
0 % UT for 0,5 cycle 0 % UT for 0,5 cycle commercial or hospital
environment. If the user of
Voltage dips and 0 % UT for 1 cycle 0 % UT for 1 cycle our product requires
voltage and 70 % UT for and 70 % UT for continued operation
interruptions 25/30 cycles 25/30 cycles during power mains
IEC 61000-4-11 interruptions, it is
0 % UT for 250/300 0 % UT for 250/300 recommended that our
cycle cycle product be powered from
an uninterruptible power
supply or a battery.

RATED power 30 A/m 30 A/m Power frequency


frequency 50 Hz / 60 Hz 50 Hz / 60 Hz magnetic fields should be

9-14
Appendices

magnetic fields at levels characteristic of a


IEC 61000-4-8 typical location in a typical
commercial or hospital
environment.
Note: UT is the A.C. mains voltage prior to application of the test level.

Table 9-3 Guidance and Declaration-Electromagnetic Immunity

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.
IEC60601 Compliance Electromagnetic
Immunity test
test level level environment-guidance
3 Vrms Portable and mobile RF
150 kHz to 80 3 Vrms communications equipment should be
Conducted used no closer to any part of the
MHz
disturbances device, including cables, than the
induced by RF 6 Vrms
recommended separation distance
fields in ISM bands a
calculated from the equation
between 0,15 6 Vrms
IEC61000-4-6 applicable to the frequency of the
MHz and 80
transmitter.
MHz
Recommended separation distances:
Radiated RF EM 3 V/m
 3 .5 
fields 80 MHz to 2.7 3 V/m d    P
 V  150k to 80 MHz
IEC61000-4-3 GHz
 3 .5 
d    P
27 V/m  E 
27 V/m 80 MHz to 800 MHz
380–390 MHz
7
d    P
28 V/m E 800 MHz to 2.7 GHz
430–470 Where P is the maximum output
MHz, power rating of the transmitter in
Proximity fields 800–960 watts (W) according to the transmitter
from RF MHz, 28 V/m manufacturer and d is the
wireless 1700–1990 recommended separation distance in
communications MHz, meters (m).
equipment 2400–2570 Field strengths from fixed RF
IEC61000-4-3 MHz transmitters, as determined by an
9 V/m electromagnetic site survey b, should
704–787 be less than the compliance level in
MHz, 9 V/m each frequency range c. Interference
5100–5800 may occur in the vicinity of equipment
MHz marked with the following

9-15
Appendices

symbol: .

Note 1: At 80 MHz to 800 MHz, the higher frequency range applies.


Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a. The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are
6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and
40.66 MHz to 40.70 MHz.
b. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the device is used
exceeds the applicable RF compliance level above, the device should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the device.
c. Over the frequency ranges 150 kHz to 80 MHz, field strengths should be less than 3V/m.

9-16
Appendices

Table 9-4 Recommended Separation Distance between Portable and Mobile RF,

Communications Equipment and This Equipment

Recommended Separation Distance between Portable and Mobile RF,


Communications Equipment and This Equipment
The equipment is intended for use in an electromagnetic environment in which radiated RF
disturbance 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 communication equipment.
Separation distance according to frequency of transmitter (m)
Rated Maximum
150kHz-80MHz 80MHz-800MHz 800MHz-2.7GHz
Output power of
Transmitter Watts  3 .5   3 .5  7
d  P d  P d   P
(W)  V   E  E

0.01 0.12 0.12 0.23


0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters at a maximum output power not listed above, the recommended separation
distance D in meters (m) can be determined using the equation applicable to the frequency of
the transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
Note 1: At 80 MHz to 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

9-17
Appendices

B Index
Heavy Quadrate Clamp, 6-6
A Heavy Radial Clamp, 6-2

Aldehyde, 8-7 Humidity limitation, 1-3

Alternating current, 1-2


Arm board, 8-1
L
Atmospheric pressure, 1-3 Leg plate, 1-1, 2-19
Light Anesthesia Frame, 7-4
B Light Arm Board, 8-5

Back plate, 1-1 Light Quadrate Clamp, 6-8

Base, 1-1 Light Radial Clamp, 6-4

Base cover, 2-13 Locking handle, 6-2

Body Elevator, 2-21 Locking screw, 6-2

C M
Clamp housing, 6-2 Manufacturer, 1-3

Cleaning, 3-3, 3-6


Corded Hand Control, 2-6
P
Potential Equalization, 2-5
D Power Indicator, 2-10

Date of manufacture, 1-2 Power Socket, 2-2, 2-4

Direct current, 1-2 Power Switch, 2-2, 2-4

Disinfection, 3-5, 3-7 Protective earth, 1-2

E Q
Equipotentiality, 1-2 Quaternary compound, 8-7

ESD warning, 1-3


R
F Recommended Cleaning Agents and

Flex position, 2-8 Disinfectants, 3-2


Foam Pad, 2-15
S
G Seat plate, 1-1
Graphical Symbols, 1-2 Serial number, 1-2

Guanidine derivative, 8-7


T
H Table Pad, 2-15, 3-6

Head plate, 1-1, 2-17 Temperature limitation, 1-3

Heavy Anesthesia Frame, 7-2 Tilt to left, 2-8


Heavy Arm Board, 8-2 Trendelenburg position, 2-8

9-18
This page is intentionally blank.
P/N: 046-007673-00(6.0)

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