Professional Documents
Culture Documents
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).
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.
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
II
Warranty
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.
Malfunction of the device or part whose serial number is not legible enough.
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
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
1
Table of Contents
2
1 System Overview
1.1 Definitions
Symbol Meaning
Serial number
Date of manufacture
Manufacturer
Humidity limitation
Atmospheric pressure
1-1
System Overview
1-2
System Overview
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.
1-3
System Overview
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.
1-5
System Overview
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
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
2.2.1 Components
2
4 3 1
7
8
6
9
10 11
2-2
Daily Operations
The warning label on the long swivel bar and the pelvis extension plate is shown in the figure
below.
The warning label means: do not sit on the long swivel bar or the pelvis extension plate.
An orange warning label can be found on the telescopic part of the long swivel bar as shown
in the figure below.
Limit label
The limit label means: do not extend the telescopic part beyond this label.
2-3
Daily Operations
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.
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.
Left label
Right label
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.
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
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.
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
1. Insert the supports into the installing holes on the long swivel bars and tighten the
locking knob (1).
When adjusting the operating table, be sure to loosen the locking knobs of
the supports. Otherwise, it may cause property damage.
2-8
Daily Operations
7. Move away the transport cart and then lock the castors.
Grooves of the
transport cart
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
2.3.1 Components
1 2
4
5
2-10
Daily Operations
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
2-11
Daily Operations
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
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
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.
7. Check the installed supine position extension assembly against the figure below, and
make sure every component is installed properly.
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
2.4.1 Components
2 1
2-15
Daily Operations
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
2-16
Daily Operations
2.5.1 Components
Traction assembly
adaptor
Countertraction
assembly
Traction bow
Leg support
1 2
3
4
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
Assembly
1. Install the main structure. See chapter 2.2.3 for details.
Countertraction post
Extension tube
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
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
6
1 4
3
5
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.
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
2.6.1 Components
Countertraction
Foot support
assembly
assembly
Traction bow
7
1
5
3
2
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
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.
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.
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
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
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.
Round clamp
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
2-27
Daily Operations
9. Slide the traction boot onto the rail of the foot support assembly and then tighten the
locking knob.
Rail
10. Check the installed lateral femur nailing assembly against the figure below, and make
sure every component is installed properly.
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.
2-29
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3 Maintenance
3.1 Cleaning
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.
1. Use the concentrated cleaning agent to clean the orthopaedic extension device.
Be sure to only use the recommended agents and methods to clean the
orthopaedic extension device.
3-1
Maintenance
3.2 Disinfection
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.
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.
4-1
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5 Technical Specifications
A.1 Environment
5-1
Technical Specifications
A.2 Specifications
1. The traction range of the orthopaedic extension device: 0-400mm.
5-2
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P/N: 046-004544-00(2.0)