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Operator’s Manual

HyExtent-3
Orthopaedic Extension Device
Copyright

The device bears CE mark indicating its conformity with the provisions of the Council
Directive 93/42/EEC concerning medical devices and fulfills the essential requirements of
Annex I of this directive.

© 2012-2013 Nanjing Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issued date is 2013-04 (Version: 2.0).

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. , 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 can cause
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.

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.

III
Contact Information
Manufacturer: Nanjing Mindray Bio-Medical Electronics Co., Ltd.
Address: 666# Middle Zhengfang Road, Jiangning, 211100 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 Definitions .................................................................................... 1-1
1.1.1 Graphical Symbols .............................................................. 1-1
1.1.2 Safety Notes........................................................................ 1-2
1.2 Intended Use................................................................................ 1-3
1.3 Fundamental Safety Instructions .................................................. 1-4
1.3.1 Instructions against Personal Injury ..................................... 1-4
1.3.2 Instructions against Device Damage .................................... 1-6

2 Daily Operations··················································································2-1
2.1 Inspection before Use .................................................................. 2-1
2.2 Main Structure .............................................................................. 2-2
2.2.1 Components ........................................................................ 2-2
2.2.2 Warning Label ..................................................................... 2-3
2.2.3 Installing the Main Structure................................................. 2-4
2.2.4 Installing the Supports ......................................................... 2-8
2.2.5 Removing the Main Structure............................................... 2-9
2.3 Supine Position Assembly .......................................................... 2-10
2.3.1 Components ...................................................................... 2-10
2.3.2 Installing and Using the Supine Position Assembly............. 2-11
2.4 Pelvis Extension Plate Assembly (Optional) ................................ 2-15
2.4.1 Components ...................................................................... 2-15
2.4.2 Installing and Using the Pelvis Extension Plate Assembly .. 2-16
2.5 Tibia and Fibula Extension Assembly (Optional) ......................... 2-17
2.5.1 Components ...................................................................... 2-17
2.5.2 Installing and Using the Tibia and Fibula Extension
Assembly….. .............................................................................. 2-19
2.6 Lateral Femur Nailing Assembly (Optional) ................................. 2-23
2.6.1 Components ...................................................................... 2-23
2.6.2 Installing and Using the Lateral Femur Nailing Assembly ... 2-25

3 Maintenance ························································································3-1
3.1 Cleaning....................................................................................... 3-1
3.2 Disinfection .................................................................................. 3-2

4 Troubleshooting ··················································································4-1

5 Technical Specifications ····································································5-1


A.1 Environment ................................................................................. 5-1

1
Table of Contents

A.1.1 Operating Environment ........................................................ 5-1


A.1.2 Storage and Transportation.................................................. 5-1
A.2 Specifications ............................................................................... 5-2

2
1 System Overview

1.1 Definitions

1.1.1 Graphical Symbols

You can see the following symbols on the operating table:

Table 1-1 Symbol definition

Symbol Meaning

Caution, consult accompanying documents

Serial number

Date of manufacture

Manufacturer

Authorized representative in the European


Community

Humidity limitation

Atmospheric pressure

Labeling for Class I products. Developed and


marketed in compliance with medical device
directive 93/42/EEC.

1-1
System Overview

1.1.2 Safety Notes

Table 1-2 Definitions of safety notes

Safety Notes Meaning

Read the statement below the symbol. The statement alerts


you to an operating hazard that can cause personnel injury.

Read the statement below the symbol. The statement alerts


you to possible damage to the device or other property.

Read the statement below the symbol. The statement alerts


you to information that requires your attention.

1-2
System Overview

1.2 Intended Use

The orthopaedic extension device is intended to be used with the HyBase series operating
tables only. It is intended for positioning the lower extremities when treating fractures.

 Contents of this manual are based on the full configuration of the


orthopaedic extension device. Some of them may not apply to your device.
Use your orthopaedic extension device according to the actual
configuration. If you have any question, contact the customer service
department authorized by Nanjing Mindray or your local distributor.

1-3
System Overview

1.3 Fundamental Safety Instructions

1.3.1 Instructions against Personal Injury

 The orthopaedic extension device is a part of the operating table system.


Familiarize yourself with how to use the operating table before installing and
using it.
 Before installing and using the orthopaedic extension device, be sure to
read and fully understand this manual.
 To use the orthopaedic extension device safely and effectively, be sure to
install and use it strictly as instructed in the manual.

 The orthopaedic extension device is to be used for its intended purposes


only. Do not use it for other purposes.

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


 Be careful when installing or removing accessories. Otherwise, they can fall
and cause personal injury and/or property damage.
 When adjusting the operating table or the patient’s position, do not reach
beneath the table top or between the moving parts. Otherwise, you can be
pinched.
 Be sure to use the orthopaedic extension device on the operating table
provided by Nanjing Mindray only. Do not use it on other devices.
Otherwise, it may result in personal injury.
 Unexpected table movement with the patient not secured could cause
personal injury. Depending on the requirements, the patient must be
secured to the operating table using the appropriate accessories.
 Be sure to check the functionality of the orthopaedic extension device as
well as the complete operating table system every year.
 Be sure to install the orthopaedic extension device onto the seat plate. Do
not install it onto the back plate. Otherwise, it can cause personal injury
and/or property damage.
 Be sure to place the patient gently onto the orthopaedic extension device.
Any impact may tip it over.
 Make sure the countertraction post is covered with surgical drape. Do not
make patient directly in contact with the countertraction post.

1-4
System Overview

 When used with the HyBase 6100 operating table, the orthopaedic extension
device can bear a maximum of 100kg load including all the accessories
installed on it. When used with the HyBase 3000 operating table, the
orthopaedic extension device can bear a maximum of 90kg load including
all the accessories installed on it.
 When the orthopaedic extension device is fully lifted off the transport cart,
make sure the installing grooves of the guiding devices and the bolts of the
adapters are fully engaged. Otherwise, the orthopaedic extension device
may fall during the surgery and cause personal injury and/or property
damage.
 The maximum tensile load of the traction assembly is 70kg. Do not use it
beyond this limit. Otherwise, it can cause personal injury and/or property
damage.
 Make sure there is no aging or damage before use. If the device is worn or
damaged, replace it at once.

 Before installing the orthopaedic extension device, make sure the castors of
the operating table are fixed.
 When used with operating table, orthopaedic extension device cannot be
used for moving patient, not even within the surgical department.
Otherwise, it can cause personal injury and/or property damage.
 When adjusting the operating table or the patient’s position, do not touch
the joints of the orthopaedic extension device.
 When mounting the accessories, make sure they are attached correctly and
tightened securely. Do not use damaged or worn accessories. Check correct
attachment before using any accessory.
 Be careful when installing or removing accessories. Otherwise, they can fall
and cause personal injury and/or property damage.

 When using an electrosurgical unit, be sure to strictly follow the operator’s


manual provided by its manufacture. Otherwise, it can cause fire hazard.

1-5
System Overview

1.3.2 Instructions against Device Damage

 When using operating tables with longitudinal shift, the table top must be
shifted to the head end as far as possible before attaching the orthopaedic
extension device.
 Never press the function key “Longitudinal shift toward head end” after
attaching the orthopaedic extension device. Hazard of collision with the
operating table column.
 When the orthopaedic extension device is attached, the lateral tilt cannot be
adjusted. Hazard of collision with the operating table column and the
adapter.

 When adjusting the operating table, make sure that the suspended parts
(such as arm boards, leg plates) do not collide with other things in the
operating room.
 When adjusting the operating table, be sure to loosen the locking knobs of
the supports. Otherwise, it may cause property damage.
 When adjusting the operating table, make sure the accessories or the
surgical drapes are not jammed by the joint.
 Stop shifting the operating table toward the head end at the time you hear a
crack when the operating table is actuated unexpectedly.

1-6
2 Daily Operations

2.1 Inspection before Use

The orthopaedic extension device and its accessories are 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 find any sign of wear and/or damage.

 Be sure to check the orthopaedic extension device each time before use. Do
not use worn or damaged orthopaedic extension devices.
 Be sure to lock the castors of the operating table before installing the
orthopaedic extension device.

2-1
Daily Operations

2.2 Main Structure

2.2.1 Components
2

4 3 1

7
8

6
9

10 11

Figure 2-1 Main structure

1 Guiding device 2 Pelvis plate


3 Swivel bar, short 4 Swivel bar, long
5 Locking knob 6 Support
7 Round clamp 8 Joint (swivel bar)
9 Transport cart 10 Adapter (right)
11 Adapter (left)

2-2
Daily Operations

2.2.2 Warning Label

2.2.2.1 Warning Label

The warning label on the long swivel bar and the pelvis extension plate is shown in the figure
below.

Figure 2-2 Warning label

The warning label means: do not sit on the long swivel bar or the pelvis extension plate.

2.2.2.2 Limit Label

An orange warning label can be found on the telescopic part of the long swivel bar as shown
in the figure below.

Limit label

Figure 2-3 Limit label

The limit label means: do not extend the telescopic part beyond this label.

2-3
Daily Operations

2.2.3 Installing the Main Structure

 Be sure to install the orthopaedic extension device onto the seat plate. Do
not install it onto the back plate. Otherwise, it can cause personal injury
and/or property damage.

1. Remove the leg plates.

2. Use the transport cart to move the orthopaedic extension device to the operating table.

 When using operating tables with longitudinal shift, the table top must be
shifted to the head end as far as possible before attaching the orthopaedic
extension device.

3. Press the button on the left adapter and insert it into the left (patient’s left) installing
socket for the leg plate, and then tighten the fixing screw. Install the right adapter in the
same way.

Label on the left adapter

Button Installing socket

Adapter (left) Fixing


screw
Figure 2-4 Installing the adapter

Left label
Right label

Figure 2-5 Labels on the adapters

2-4
Daily Operations

 Make sure the 2 fixing screws are tightened after the adapters are installed.
Otherwise, the orthopaedic extension device can fall and cause personal
injury and/or property damage.

 Make sure the left adapter is installed on the patient’s left side. Otherwise,
the main structure cannot be properly installed.

4. Adjust the table top to the 0-position.

5. Slightly tilt the operating table to foot end about 1°.

 The operating table should be in a slight reverse trendelenburg position


(approx. 1°) so that the main structure of orthopaedic extension device can
be installed or removed smoothly.

6. Adjust the table top to an appropriate height. Make sure that the table top is lower than
the groove on the guiding device.

Grooves

Table top

Figure 2-6 Adjusting the height of the operating table

2-5
Daily Operations

7. Push the transport cart until the bolts of the adapters and the lower parts of the guiding
devices are in full contact.

Lower parts of the guiding devices

Bolts of the adapters


Figure 2-7 Position of the transport cart

8. Lift the table top until the installing grooves of the guiding device and the bolts of the
adapter are fully engaged, and the orthopaedic extension device is fully lifted off the
transport cart. Then roll away the transport cart.

Bolts of
the
adapters

Installing
grooves of the
guiding device
Transport cart

Figure 2-8 Lifting the orthopaedic extension device off the transport cart

 Before lifting the orthopaedic extension device fully off the transport cart,
make sure the installing grooves of the guiding devices and the bolts of the
adapters are fully engaged. Otherwise, the orthopaedic extension device
may fall off during the surgery and cause personal injury and/or property
damage.

2-6
Daily Operations

 Never press the function key “Longitudinal shift toward head end” after
attaching the orthopaedic extension device. Hazard of collision with the
operating table column.
 When adjusting the operating table, make sure that the suspended parts
(such as arm boards, leg plates) do not collide with other things in the
operating room.

2-7
Daily Operations

2.2.4 Installing the Supports

1. Insert the supports into the installing holes on the long swivel bars and tighten the
locking knob (1).

2. Adjust the supports to an appropriate height if necessary.


3. Tighten the locking knob (2).

Locking knob (1)

Locking knob (2)

Figure 2-9 Installing the support

 When adjusting the operating table, be sure to loosen the locking knobs of
the supports. Otherwise, it may cause property damage.

 The supports have to be installed to increase stability.

2-8
Daily Operations

2.2.5 Removing the Main Structure

1. Remove the support.


2. Remove all the accessories, such as the traction assembly and traction boot, from the
main structure.
3. Adjust the swivel bars to make them in parallel. Make sure the telescopic parts of the
long swivel bars are fully retracted.
4. Raise the operating table top as far as necessary so that the transport cart can be
moved under the extension device.
5. Lower the operating table until the bolts of the guiding devices are fully engaged with the
grooves of the transport cart, and the main structure is fully separated from the adapter.
6. Roll away the main structure with the transport cart.

7. Move away the transport cart and then lock the castors.

Bolts of the guiding device

Grooves of the
transport cart

Figure 2-10 Removing the main structure

 When removing the orthopaedic extension device, make sure the bolts of
the guiding device are fully engaged with the grooves of the transport cart.
Otherwise, the orthopaedic extension device may fall during transportation
and cause personal injury and/or property damage.

 When removing the orthopaedic extension device, make sure both the
pelvis plate and swivel bars are placed on the transport cart.

2-9
Daily Operations

2.3 Supine Position Assembly

2.3.1 Components

1 2

4
5

Figure 2-11 Supine position assembly

1 Countertraction post 2 Leg support (optional)


3 Foot support assembly 4 Traction boot
5 Traction assembly

2-10
Daily Operations

2.3.2 Installing and Using the Supine Position Assembly

1. Install the main structure. See the chapter 2.2.3 for details.

2. Slide the countertraction post into the installing socket near the patient’s injured leg.

Countertraction post

Installing socket
Figure 2-12 Installing the countertraction post

 Be sure to slide the countertraction post into the installing socket near the
patient’s injured leg.

3. Insert the traction assembly into the square opening on the long swivel bar (on the same
side of the countertraction post). After adjusting the traction assembly to an appropriate
height, tighten handle 5. Use handles 1, 2, 3 and 4 to adjust the traction assembly to an
appropriate position. Then tighten all the handles.

Rail
1
4

2
3
L-Support
5

Opening

Figure 2-13 Installing the traction assembly

2-11
Daily Operations

Figure 2-14 Scale on the screw tension device

4. Slide the foot support assembly into the square clamp on the swivel bar (opposite to the
injured leg). Adjust it to an appropriate position and then lock it.

Foot support

L-Support

Figure 2-15 Installing the foot support assembly

5. Slide the traction boots onto the rails of the traction assembly and/or the foot support
assembly and then tighten them.

Traction boot
Rail

Figure 2-16 Installing the traction boot

2-12
Daily Operations

6. Slide the leg support (optional) into the round clamp on the swivel bar (opposite to the
injured leg). Adjust it to an appropriate position and then lock it.

Figure 2-17 Installing the leg support

7. Check the installed supine position extension assembly against the figure below, and
make sure every component is installed properly.

Figure 2-18 Supine position assembly

2-13
Daily Operations

 Before using the orthopaedic extension device, make sure that the patient’s
feet are fixed reliably with the straps of the traction boots. Otherwise, it can
cause personal injury and/or property damage.

 Make sure that the countertraction post is covered with surgical drape.

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

 When adjusting the position of the traction assembly or the foot support
assembly with patient’s foot on it, make sure the L-support is vertical to the
long swivel arm. Otherwise, you may find difficulty in moving the assembly.

2-14
Daily Operations

2.4 Pelvis Extension Plate Assembly (Optional)

2.4.1 Components

2 1

Figure 2-19 Pelvis extension plates

1 Pelvis extension plate (left) 2 Pelvis extension plate (right)

2-15
Daily Operations

2.4.2 Installing and Using the Pelvis Extension Plate

Assembly
1. Loose the locking knob.

2. Insert the right pelvis extension plate into the installing socket on the guiding device. And
then tighten the locking knob.

Installing
socket

Locking knob

Right pelvis
extension plate
Figure 2-20 Installing the right pelvis extension plate

3. Install the left pelvis extension plate in the same way.


4. Check the installed pelvis extension plate assembly against the figure below, and make
sure every component is installed properly.

Figure 2-21 Installed pelvis extension plates

2-16
Daily Operations

2.5 Tibia and Fibula Extension Assembly (Optional)

2.5.1 Components

Traction assembly
adaptor

Countertraction
assembly

Traction bow
Leg support

1 2

3
4

Figure 2-22 Tibia and fibula extension assembly

1 Countertraction assembly 2 Leg support


3 Square clamp 4 Traction bow
5 Traction assembly adapter 6 Traction assembly

2-17
Daily Operations

 The maximum tensile load of the traction bow is 30kg. Do not use it beyond
this limit. Otherwise, it can cause personal injury and/or property damage.
 The maximum load of leg support is 10kg. Do not use it beyond this limit. It
can cause personal injury and/or property damage.
 The maximum load of the countertraction assembly for the tibia and fibula is
25kg. Do not use it beyond this limit. It can cause personal injury and/or
property damage.

2-18
Daily Operations

2.5.2 Installing and Using the Tibia and Fibula Extension

Assembly
1. Install the main structure. See chapter 2.2.3 for details.

2. Check the countertraction assembly, and locate the extension tube.

Countertraction post

Extension tube

Figure 2-23 Countertraction assembly for the tibia and fibula

3. Insert the extension tube into the installing socket on the pelvis plate, and make sure the
positioning pin on the tube is fully engaged with the groove on the socket.

Groove

Positioning pin

Figure 2-24 Positioning pin on the extension tube Figure 2-25 Groove of the socket

 Make sure that the countertraction post for the tibia and fibula is installed on
the same side of the injured leg.

2-19
Daily Operations

4. Insert the countertraction post into the extension tube and then tighten the fixing screw.

Countertraction post

Fixing screw

Figure 2-26 Installing the countertraction post for the tibia and fibula

5. Adjust the countertraction post to an appropriate height, and then tighten the locking
knob.

Locking knob

Figure 2-27 Installed countertraction post for the tibia and fibula

6. Slide the traction assembly adapter into the square opening on the long swivel bar (on
the same side of the countertraction assembly). Adjust it to an appropriate position, and
then tighten the locking knob.

Traction assembly
adaptor

Locking knob

Figure 2-28 Installing the traction assembly adapter

2-20
Daily Operations

7. Slide the traction assembly into the traction assembly adapter (on the same side of the
countertraction post). Adjust it to an appropriate position, and then tighten the locking
knob.

Locking knob

Square opening
Traction assembly
adaptor
Figure 2-29 Installing the traction assembly

8. Slide the traction bow onto the rail of the traction assembly and then tighten the locking
handle. Use handles 1, 2, 3, 4, 5 and 6 to adjust the traction bow to an appropriate status
and then tighten them.

Traction bow

Rail

Locking handle

Figure 2-30 Traction bow

6
1 4
3
5

Figure 2-31 Installing the traction bow

2-21
Daily Operations

9. Install the leg support. See step 7 in chapter 2.3.2 for details.
10. Check the installed tibia and fibula extension assembly against the figure below, and
make sure every component is installed properly.

Figure 2-32 Installed tibia and fibula extension assembly

 Before using the orthopaedic extension device, make sure that the patient’s
leg is fixed reliably with the straps of the leg support. Otherwise, it can
cause personal injury and/or property damage.

 Make sure that the countertraction post is covered with surgical drape.

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

2-22
Daily Operations

2.6 Lateral Femur Nailing Assembly (Optional)

2.6.1 Components

Countertraction
Foot support
assembly
assembly

Traction bow

Lower leg support

7
1
5

3
2

Figure 2-33 Lateral femur nailing assembly

1 Countertraction assembly 2 Traction boot


3 Foot support assembly 4 Round clamp
5 Lower leg support 6 Traction bow
7 Traction assembly

2-23
Daily Operations

 The maximum tensile load of the traction bow is 30kg. Do not use it beyond
this limit. Otherwise, it can cause personal injury and/or property damage.
 The maximum load of lower leg support is 10kg. Do not use it beyond this
limit. It can cause personal injury and/or property damage.
 The maximum load of the countertraction post for the femur is 30kg. Do not
use it beyond this limit. It can cause personal injury and/or property damage

2-24
Daily Operations

2.6.2 Installing and Using the Lateral Femur Nailing

Assembly
1. Install the main structure. See chapter 2.2.3 for details.

2. Check the countertraction assembly, and locate the positioning pin of the extension tube.

Upper countertraction post


Dam bar

Lower countertraction post

Extension tube Positioning pin

Figure 2-34 Countertraction assembly

3. Press and hold the button. Insert the positioning pin into the installing socket on the
lower part of the guiding device until the pin is fully engaged. Then undo the button.
Make sure the extension tube is reliably fixed.

Lower countertraction post

Extension tube
Installing
socket
Positioning pin

Button
Figure 2-35 Installing the countertraction post

 Make sure that the countertraction post for the femur is installed on the
opposite side of the injured leg.

2-25
Daily Operations

4. Install the dam bar and the upper countertraction post onto the extension tube.

Dam bar
Upper countertraction post

Figure 2-36 Installing the dam bar and upper countertraction post

5. Insert the traction assembly into the square opening on the long swivel bar (on the same
side of the countertraction post). After adjusting the traction assembly to an appropriate
height, tighten the handle 5. Use handles 1, 2, 3 and 4 to adjust the traction assembly to
an appropriate position. Then tighten all the handles.

1
Rail

4
2
3
5

Figure 2-37 Installing the traction bow

6. Slide the traction bow onto the rail at the end of the traction assembly and then tighten it.
Use handles 1, 2, 3, 4 and 5 to adjust the traction bow to an appropriate position and
then tighten them.
Traction bow

Rail 3 1
5

2
4

Figure 2-38 Installing the traction bow

2-26
Daily Operations

7. Slide the lower leg support into the opening of the round clamp on the long swivel bar
(on the same side of the countertraction post) and then lock it.

Lower leg support

Round clamp

Figure 2-39 Installing the lower leg support

8. Slide the foot support assembly into the long swivel bar (on the opposite side of the
countertraction post). Then tighten the locking knob.

Foot
support
assembly

Square
opening

Figure 2-40 Installing the foot support assembly

2-27
Daily Operations

9. Slide the traction boot onto the rail of the foot support assembly and then tighten the
locking knob.

Rail

Figure 2-41 Installing the traction boot

10. Check the installed lateral femur nailing assembly against the figure below, and make
sure every component is installed properly.

Figure 2-42 Installed lateral femur nailing assembly

2-28
Daily Operations

 Before using the orthopaedic extension device, make sure that the patient’s
leg is fixed reliably with the straps of the lower leg support. Otherwise, it can
cause personal injury and/or property damage.
 Make sure that the countertraction post is covered with surgical drape.

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

 When adjusting the position of the traction assembly with patient’s foot on
it, make sure the L-support is vertical to the long swivel arm. Otherwise, you
may find difficulty in moving the assembly.

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3 Maintenance

3.1 Cleaning

All-purpose cleaning agents are recommended.

 Use the mildly alkaline cleaning agent (soap solution) to clean the
orthopaedic extension device.
 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 orthopaedic extension
device, 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 orthopaedic extension device.

2. Rinse the orthopaedic extension device with clean water.

3. Use a dry cloth to wipe the orthopaedic extension device.

 Be sure to only use the recommended agents and methods to clean the
orthopaedic extension device.

 Do not use polishing/scouring agents.


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

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Maintenance

3.2 Disinfection

The following disinfectants are recommended:

 Aldehydes

 Quaternary compounds
 Guanidine derivatives

 Do not use the 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.

 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 water containing metal particles, any metal tools (such as wire
brushes or steel wool), or products containing hydrochloric acid.

 Do not disinfect the orthopaedic extension device mechanically.

3-2
4 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. Adjust the operating table
to a slight reverse
The orthopaedic extension
The bolts of the adapters are trendelenburg position.
device cannot follow with the not fully engaged with the
2. Make sure the lower parts
operating table when moving installing sockets of the
guiding device. of the guiding devices and
them.
the bolts of the adapters are
fully engaged.

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5 Technical Specifications

A.1 Environment

A.1.1 Operating Environment


1. Temperature: 5°C-40°C

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


3. Atmospheric pressure: 70kPa-106kPa

A.1.2 Storage and Transportation


1. Temperature: -40°C-+60°C
2. Humidity: 10%-95%, non-condensing

3. Atmospheric pressure: 50kPa-106kPa

 During transportation, make sure that the orthopaedic extension device is


well protected from rain, snow or mechanical collision.
 The orthopaedic extension device should be installed in a room that is dry,
draughty and without caustic gas.

5-1
Technical Specifications

A.2 Specifications
1. The traction range of the orthopaedic extension device: 0-400mm.

2. Lateral adjustment range: 0°- 220°.


3. The adjustment range of the screw tension device: 180mm.

4. The maximum traction of the traction assembly: 686N.

5. The maximum load of the support: 20kg.


6. The maximum load of the orthopaedic extension device combined with the HyBase 6100
operating table, including all the accessories installed on it, is 100kg.
7. The maximum load of the orthopaedic extension device combined with the HyBase 3000
operating table, including all the accessories installed on it, is 90kg.

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P/N: 046-004544-00(2.0)

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