Arthrex AR-6529S User manual

Hip Distraction System
Instructions for Use
Product No. AR-6529S
D-720763
Version C

INSTRUCTIONS FOR USE
Document Number: D-720763 Page 2 Issue Date: 31 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
ENGLISH ......................................................................................................................................... 3
FRANÇAIS .................................................................................................................................... 35
DEUTSCH ...................................................................................................................................... 68
ITALIANO ................................................................................................................................... 102
ESPAÑOL ................................................................................................................................... 136
OTHER LANGUAGES ................................................................................................................. 170

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IMPORTANT NOTICES
•Read and understand all warnings in this manual and on the device itself
prior to use with a patient.
•The symbol is intended to alert the user to important procedures or
safety instructions regarding the use of this device.
The symbol on the labels is intended to show when the IFU should be
referenced for use.
•The techniques detailed in this manual are only manufacturer’s suggestions.
The final responsibility for patient care with respect to this device remains
with the attending physician.
•Device function should be checked prior to each usage.
•This device should only be operated by trained personnel.
•All modifications, upgrades, or repairs must be performed by an authorized
specialist.
•Keep this manual available for future reference.
•Any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority listed in this
document.
Prior to using this or any other type of medical apparatus with a
patient, it is recommended that you read the Instructions for Use and
familiarize yourself with the product.

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Table of Contents
Hip Distractin System (AR-6529S)
1General Information........................................................................................................... 6
1.1 Copyright Notice:........................................................................................................ 6
1.2 Trademarks:............................................................................................................... 6
1.3 Contact Details:.......................................................................................................... 7
1.4 Safety Considerations:............................................................................................... 7
1.4.1 Safety hazard symbol notice:........................................................................... 7
1.4.2 Equipment misuse notice:................................................................................ 7
1.4.3 Notice to users and/or patients:........................................................................ 7
1.4.4 Safe disposal: .................................................................................................. 8
1.5 Operating the system:................................................................................................ 8
1.5.1 Applicable Symbols:......................................................................................... 8
1.5.2 Intended User and Patient Population:............................................................. 9
1.5.3 Compliance with medical device regulations:.... Error! Bookmark not defined.
1.6 EMC considerations:.................................................................................................. 9
1.7 EC authorized representative:.................................................................................... 9
1.8 Manufacturing Information:........................................................................................10
2System.............................................................................................................................11
2.1 System components Identification:............................................................................11
2.2 Product Code and Description:..................................................................................13
2.3 List of Accessories and Consumable Components Table:.........................................13
2.4 Indication for use:......................................................................................................14
2.5 Intended use:............................................................................................................14
2.6 Residual risk: ............................................................................................................14
3Equipment Setup and Use:...............................................................................................15
3.1 Prior to use:...............................................................................................................15
3.2 Setup: .......................................................................................................................15
3.3 Device controls and indicators:..................................................................................26
3.4 Storage, Handling and Removal Instructions:............................................................27
3.4.1 Storage and Handling: ....................................................................................27
3.4.2 Removal Instruction: .......................................................................................28
3.5 Troubleshooting Guide:.............................................................................................29

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3.6 Device Maintenance:.................................................................................................29
4Safety Precautions and General Information:...................................................................29
4.1 General Safety Warnings and Cautions: ...................................................................29
4.2 Product Specifications:..............................................................................................31
4.3 Contraindications: .....................................................................................................32
4.4 Sterilization Instruction:.............................................................................................32
4.5 Cleaning and Disinfection Instruction: .......................................................................32
5List of Applicable Standards:............................................................................................33

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1General Information
AMATECH Corporation is a subsidiary of Allen Medical Systems, Inc. which is a
subsidiary of Hill-Rom, Inc. (NYSE: HRC), a leading worldwide manufacturer and
provider of medical technologies and related services for the health care industry. As
an industry leader in patient positioning, our passion is improving patient outcomes
and caregiver safety, while enhancing our customers' efficiency. Our inspiration
comes from providing innovative solutions to address our customers' most pressing
needs. We immerse ourselves in our customers' world, to better address these needs
and the daily challenges of their environment. Whether developing a solution to
address patient positioning challenges or creating a system to offer safe and effective
surgical site access for the surgical team, we are committed to providing products of
exceptional value and quality.
1.1 Copyright Notice:
Revision
© 2019 Allen Medical Systems Inc. ALL RIGHTS RESERVED.
No part of this text shall be reproduced or transmitted in any form or by any means,
electronic or mechanical, including photocopying, recording, or by any
information or retrieval system without written permission from Allen Medical
Systems, Inc. (Allen Medical).
The information in this manual is confidential and may not be disclosed to third
parties without the prior written consent of Allen Medical.
1.2 Trademarks:
Trademark information can be found in
www.allenmedical.com/pages/terms-conditions.
Product may be covered by one or more patents. Please consult listing at
www.hill-rom.com/patents for any patent(s).

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1.3 Contact Details:
For ordering information please see catalog.
customer service Information:
Address:
1370 Creekside Blvd
Naples, FL 34108
1.4 Safety Considerations:
1.4.1 Safety hazard symbol notice:
DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE AND MATERIAL
DEGRADATION.
1.4.2 Equipment misuse notice:
Do not use product if package is damaged or unintentionally opened before use.
All modifications, upgrades, or repairs must be performed by an authorized specialist.
1.4.3 Notice to users and/or patients:
Any serious incident that has occurred in relation to the device should be reported
using the contact details provided in section 1.3 of this Instruction for Use and to the
competent authority of the Member State in which the user and/or patient is
established.
Note: Refer to the surgical table manufacturer's user guide for instructions on use.
Always refer to the surgical table manufacturer’s weight limits.
NEVER EXCEED THE WEIGHT CAPACITY OF THE OPERATING ROOM TABLE
1-800-934-4404
[phone]
International
North America

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1.4.4 Safe disposal:
Customers should adhere to all federal, state, regional, and/or local laws and
regulations as it pertains to the safe disposal of medical devices and accessories.
If in doubt, the users of the device shall first contact their supplier for guidance on
safe disposal protocols.
1.5 Operating the system:
1.5.1 Applicable Symbols:
Symbol used
Description
Reference
Indicates the device is a medical
device
MDR 2017/745
Indicates the medical device
manufacturer
EN ISO 15223-1
Indicates the manufacturer’s serial
number. The device serial number is
encoded as 1YYWWSSSSSSS.
YY indicates the year of
manufacture. i.e. 118WWSSSSSSS
where 18 represents the year 2018.
WW indicates the number of the
manufacturing week per a
standard shop calendar. (Leading
zeros included.)
SSSSSSS is a sequential unique
number.
EN ISO 15223-1
Indicates the medical device Global
Trade Item Number
21 CFR 830
MDR 2017/745
Indicates the date when the medical
device was manufactured
EN ISO 15223-1
Indicates the manufacturer’s lot code
using the Julian Date yyddd, where yy
indicates the last two digits of the year
and ddd indicates the day of the year.
i.e. April 4th, 2019 would be represented
as 19094.
EN ISO 15223-1

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Indicates the manufacturer’s
catalogue number
EN ISO 15223-1
Indicates the need for the user to
consult the instructions for use for
important cautionary information such
as warnings and precautions
EN ISO 15223-1
Indicates the device do not contain
natural rubber or dry natural rubber
latex
EN ISO 15223-1
Indicates the authorized representative
in the European Community
EN ISO 15223-1
Indicates the Medical Device complies
to REGULATION (EU) 2017/745
MDR 2017/745
Indicates a Warning
IEC 60601-1
Intended to show when the IFU should
be referenced for use
EN ISO 15223-1
1.5.2 Intended User and Patient Population:
Intended User: Surgeons, Nurses, Doctors, Physicians and OR healthcare
professionals involved in the device intended procedure. Not intended for Lay
persons.
Intended Populations:
This device is intended to be used with patients that do not exceed the weight in the
safe working load field specified in the product specification section 4.2
1.6 EMC considerations:
This is not an electromechanical device. Therefore, EMC Declarations are not
applicable.
1.7 EC authorized representative:
HILL-ROM SAS
B.P. 14 - Z.I. DU TALHOUET

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56330 PLUVIGNER
FRANCE
TEL: [phone]
1.8 Manufacturing Information:
ALLEN MEDICAL SYSTEMS, INC.
100 DISCOVERY WAY
ACTON, MA 01720 USA
800-433-5774 (NORTH AMERICA)
978-266-4200 (INTERNATIONAL)

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2System
2.1 System components Identification:
System Identification
System Storage Identification

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System Identification Table
Storage Identification Table
Item
REF
Description
N/A
AR-6529-12
Replacement Pad Cover, Operative Spar
N/A
AR-6529-13
Cart, HDS
N/A
AR-6529-16
Stabilizer Leg, HDS
E
AR-6529-05
Operative Leg Spar, HDS
I
AR-6529-14
Well Leg Spar, HDS
K
AR-6529-18
Table Clamp, (UK), HDS (pair)
K
AR-6529-19
Table Clamp, (Denyer), HDS (pair)
K
AR-6529-20
Table Clamp, (Japan), HDS (pair)
H
AR-6529-21
Dense Perineal Post Pad, HDS
Item
REF
Description
A
AR-6529-01
Patient Platform, HDS
B
AR-6529-02
Patient Platform Pad, HDS
C*
AR-6529-03
Prep Table, HDS
D*
AR-6529-04
Prep Table Pad, HDS
E
AR-6529-05L
Long Operative Leg Spar, HDS
F
AR-6529-06
Traction Boot, HDS
G
AR-6529-07
Perineal Post, HDS
H
AR-6529-08
Perineal Post Pad, HDS
I
AR-6529-14L
Long Well Leg Spar, HDS
J
AR-6529-15
Well Leg Adapter, HDS
K
AR-6529-09 US or
AR-6529-10 EU
Table Clamp, HDS (pair)

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2.2 Product Code and Description:
AR-6529-01 - HDS, Patient Platform
AR-6529-06 - Traction Boot, HDS
AR-6529-03 - Prep Table Attachment, HDS
AR-6529-05L - HDS Long Operative Leg Spar
AR-6529-12 - HDS Operative Spar Cover
AR-6529-14L - HDS Long Well Leg Spar
AR-6529-15 - HDS, Well Leg Adaptor
AR-6529-16 - Stabilizer Leg, HDS
AR-6529-07 - HDS, Perineal Post
AR-6529-08 - HDS, Perineal Post Pad
AR-6529-09 - HDS, Table Clamps, US
AR-6529-10 - HDS, Table Clamps, EU
AR-6529-18 - HDS, Table Clamp Set, UK
AR-6529-19 - HDS, Table Clamp Set, DEN
AR-6529-20 - HDS, Table Clamp Set, JP
AR-6529-02 - Pad,HDS Patient Platform
AR-6529-04 - Pad,HDS Prep Table
AR-6529-17 - HDS, Boot Replacement Pad Set
AR-6529-21 - Perineal Post Pad, Dense
2.3 List of Accessories and Consumable Components Table:
The following list are accessories and components that may be used with this
device.
Name of Accessory
Product Number
Pad,HDS Patient Platform
AR-6529-02
Prep Table Attachment, HDS
AR-6529-03
Pad,HDS Prep Table
AR-6529-04
HDS Long Operative Leg Spar
AR-6529-05L
Traction Boot, HDS
AR-6529-06
HDS, Perineal Post
AR-6529-07
HDS, Perineal Post Pad
AR-6529-08
HDS Long Well Leg Spar
AR-6529-14L
HDS, Well Leg Adaptor
AR-6529-15
HDS, Table Clamps (pair)
AR-6529-09 US or AR-6529-10 EU
HDS Operative Spar Cover
AR-6529-12

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Cart, HDS
AR-6529-13
Stabilizer Leg, HDS
AR-6529-16
Operative Spar, HDS
AR-6529-05
HDS, WELL LEG SPAR
AR-6529-14
HDS, Table Clamp Set, UK
AR-6529-18
HDS, Table Clamp Set, DEN
AR-6529-19
HDS, Table Clamp Set, JP
AR-6529-20
Perineal Post Pad, Dense
AR-6529-21
Note: Consult the corresponding IFU for the products mentioned in the above table.
CAUTION: Reuse of disposables will lead to patient cross contamination and/or
device failure.
2.4 Indication for use:
The Hip Distractor System is used for hip surgery. These devices are capable of being
used with a broad patient population as determined appropriate by the caregiver
or institution.
2.5 Intended use:
The Hip Distractor System is designed to position, support and/or distract the
patient’s hip, posterior Lower torso and foot for hip surgery. These devices are
intended to be used by healthcare professionals within the Operating Room
setting.
2.6 Residual risk:
This product complies with relevant performance, safety standards. However,
patient, user or device harm from misuse, device damage or malfunction, device,
function or mechanical hazards cannot be completely excluded.
Name of Consumable
Product Number
HDS, Disposable Pad Kit
AR-6529-11

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3Equipment Setup and Use:
3.1 Prior to use:
a. Inspect the product looking for any visible damage or sharp edges that could
be caused by a drop or impact during storage.
b. Make sure product has been properly cleaned and disinfected and wiped dry
prior to each use.
3.2 Setup:
Note: Ensure that the surgical table is in its final operation location with respect to
the room.
Note: Remove X-ray tops if present from the surgical table.
Note: Ensure that the longest part of the surgical table base is located under the
HDS attachment location for greatest table stability.
Note: Ensure that the OR table wheel locks are activated before placing the
patient on the system.
Note: Remove or lower the leg section of the table by 90°.
Note: If desired, the HDS Stabilizer Leg (AR-6529-16) may be used for additional
system stability.
Clamps (AR-6529-09, AR-6529-10, AR-6529-18, AR-6529-19 or AR-6529-20)
a. Select the appropriate Clamp based on the OR table and table rail dimensions
that the system will be mounted to. There are two Table Clamps, one for the left
side and one for the right side.
b. Mount clamps to the rails by sliding them on the distal end of the rail (Fig 1A).
The end of the clamp body should be flush with end of table, with the clamp
hooks extending out beyond the end of the table. Secure the Table Clamps to
the rails by tightening the knob on the lateral aspect of the Clamp body (Fig
1B).
Fig: 1
Caution: Ensure the clamps
are securely fastened and in
the proper position on the
OR table. Failing to do so
can result in device failure
and patient fall.

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Patient Platform
a. The patient platform is width adjustable. Slide the sides of the platform out as
needed to accommodate the table width (Fig 2).
Fig: 2
b. Grab the HDS Patient Platform (AR-6529-01) by the upright or handle with your
dominant hand and support with your non-dominant hand on one of the side
handles as shown in Fig 3.
Fig: 3
c. Engage the Patient Platform forks with the spool on the side of the Table
Clamps (Fig 4A) and lower so that it rests on the Table Clamp hooks (Fig 4B).
Fig: 4

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Caution: Ensure that your finger is not pinched when lowering the Patient
Platform.
d. Note that Platform will automatically lock into the Table Clamps. Gently lift the
Patient Platform to confirm that it is secured to the Clamps. If it is necessary to
remove the Patient Platform, disengage the Table Clamp lock located on the
left Clamp (i.e., the patient left side) by pulling the silver lock button with your
thumb while reversing the above steps.
e. Slide the Patient Platform towards the operative side (Fig 5A) so the operative
site is positioned closer to the surgeon’s location. This will also provide
additional room for the Well Leg Holder to mount. Slide the Mounting Pin on
the Patient Platform towards the operative side (Fig 5B). Ensure that the knobs
(Fig 5C) are fully unscrewed so that the two red O-rings are visible (Fig 5D).
f. Attach the Patient Platform Pad (AR-6529-02) to the Patient Platform oriented
so that the opening for the Perineal Post is on the operative side of the table.
Operative Spar
a. Locate the HDS Operative Spar (AR-6529-05L or AR-6529-05); this is the Spar
with the larger joint on the proximal end and two handles on the distal end.
b. If the Operative Spar was mounted to the cart, the carriage should be locked
in place approximately 10 in (25.5cm) from the Spar joint at the proximal end
of the spar. If it is not, you can move the carriage to this position to help
balance the weight distribution of the Spar and make it easier to maneuver.
To do so, unlock the Operative Spar carriage by pushing the Carriage Lock
located on the carriage handles forward (Fig 6).
Fig: 5
Operative Side
A
B
C
C
D

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Fig: 6
c. Slide carriage so that it is located about 10 in (25.5cm) from the Spar joint and
pull the Carriage Lock lever to lock the Carriage in place.
d. Ensure that the Mounting Hook located on the underside of the Spar joint is in
line with long axis of spar. If necessary, adjust by actuating the Abduction /
Adduction handle (Fig 7) and having a co-worker adjust the angle of the
mounting hook so that it is in line with the axis of the spar.
Fig: 7
e. Lift the Spar and advance at about a 30⁰angle to engage the Mounting Hook
with the Mounting Pin (Fig 8A) on the operative side of the Patient Platform.
Lower the Spar (Fig 8B) to fully mount the Operative Spar to the Patient
Platform. Secure the Spar in place by tightening the Locking Knob (Fig 8C) on
the lateral side of the Patient Platform so that the red O-rings are no longer
visible.
Caution: Ensure that the red O-rings are no longer visible to ensure the knob is
fully tightened.
AB/Adduction
trigger

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Fig: 8
HDS Operative Spar Cover
a. Attach the Operative spar cover (AR-6529-12) to the operative spar to cover
the operative joint of the spar shown. The pad is attached by covering the joint
with the pad oriented with the label facing towards the spar and fastening the
Velcro straps below the joint (A). Next engage the elastic Velcro straps to the
Velcro located on the side of the joint (B).
b. Finally bend the top portion of the spar cover over the top of the carbon fiber
shaft. Secure the Velcro so it goes underneath and around the spar to attach
back to the pad (C).
B
A
C
A
B
C

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Well Leg Holder Adapter
a. The Well Leg Holder Adapter (AR-6529-15) will be mounted to the non-
operative side of the patient.
b. Ensure that the Locking knobs are fully unscrewed so that two red O-rings are
visible (Fig 9).
Caution: Ensure that the red O-rings are no longer visible to ensure the knob is fully
tightened.
c. The Adapter is reversible. Orient the Adapter so that it angles medially, and the
two Locking Knobs are on the lateral side of the Adapter when mounted to the
non-operative side as shown in Fig 10 and on the labels on the Adapter. Slide
the Adapter into the opening on the bottom of the Table Clamp on the non-
operative side of the table by sliding it into the receiver underneath the Table
Clamp as shown in Fig 10.
Fig 10
d. Secure the Adapter in place by tightening the proximal Locking Knob (Fig 16A)
so that the red O-rings are no longer visible.
B
A
Fig 9