Hillrom A-93005 User manual

Traction Boot Systems
Instructions for Use
Product No. A-93005, A-93006, A-93007
80028199
Version B
ATB - Modular Attachment
for Mizuho OSI ®Systems
A-93007
ATB - Modular Attachment
for Steris® Systems
A-93006
Allen® Traction Boot –Modular
A-93005

INSTRUCTIONS FOR USE
Document Number: 80028199 Page 2 Issue Date: 31 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
ENGLISH.......................................................................................................................................... 3
DANSK .......................................................................................................................................... 29
FRANÇAIS..................................................................................................................................... 54
DEUTSCH....................................................................................................................................... 79
ITALIANO .................................................................................................................................... 104
ROMÂNESC................................................................................................................................ 130
SRPSKI ......................................................................................................................................... 157
SLOVENSKY ................................................................................................................................ 183
SLOVENŠČINA ........................................................................................................................... 209
ESPAÑOL .................................................................................................................................... 235
SVENSKA..................................................................................................................................... 262

INSTRUCTIONS FOR USE
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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.

INSTRUCTIONS FOR USE
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Table of Contents
Allen®Traction Boot Systems (A-93005, A-93006, A-93007)
1. General 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: .......................................... 10
1.6 EMC considerations: ................................................................................................ 10
1.7 EC authorized representative:................................................................................ 10
1.8 Manufacturing Information:.................................................................................... 10
1.9 EU Importer Information:.......................................................................................... 10
1.10 Australian sponsor Information: .............................................................................. 10
2. System ................................................................................................................................. 11
2.1 System components Identification: ....................................................................... 11
2.2 Product Code and Description:............................................................................. 12
2.3 List of Accessories and Consumable Components Table:................................. 12
2.4 Indication for use:..................................................................................................... 13
2.5 Intended use: ............................................................................................................ 13
2.6 Residual Risk:.............................................................................................................. 13
3. Equipment Setup and Use:............................................................................................... 13
3.1 Prior to use: ................................................................................................................ 13
3.2 Setup: ......................................................................................................................... 17
3.3 Device controls and indicators: ............................................................................. 21
3.4 Storage, Handling and Removal Instructions: ...................................................... 22

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3.4.1 Storage and Handling: ................................................................................... 22
3.4.2 Removal Instruction:........................................................................................ 23
3.5 Troubleshooting Guide: ........................................................................................... 24
3.6 Device Maintenance:.............................................................................................. 24
4. Safety Precautions and General Information:............................................................... 24
4.1 General Safety Warnings and Cautions:............................................................... 24
4.2 Product Specifications:............................................................................................ 25
4.3 Sterilization Instruction:............................................................................................. 26
4.4 Cleaning and Disinfection Instruction:................................................................... 26
5. List of Applicable Standards: ........................................................................................... 27

INSTRUCTIONS FOR USE
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1. General Information:
Allen Medical Systems, Inc. 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.
Allen products are backed by responsive and reliable service and complimentary on-
site product demonstrations.
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 at Allenmedical.com/pages/terms-
conditions.
Products may be covered by one or more patents. Please consult listing at
Hill-rom.com/patents for any patent(s).

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International
North America
1.3 Contact Details:
For ordering information please see catalog.
Allen Customer Service Contact Information:
1.4 Safety Considerations:
1.4.1 Safety hazard symbol notice:
DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE OR MATERIAL
DEGRADATION.
1.4.2 Equipment misuse notice:
Do not use the 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
to the manufacturer and 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
[phone]
[phone] ext.4286
[phone]
[phone]

INSTRUCTIONS FOR USE
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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 user of the device shall first contact Hill-Rom Technical Support 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 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 date when the medical
device was manufactured
EN ISO 15223-1
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
Indicates the need for the user to
consult the instruction 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.

INSTRUCTIONS FOR USE
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1.5.3 Compliance with medical device regulations:
This Product is a non-invasive, Class I Medical Device. This system is CE-
marked according to Annex VIII, Rule 1, of the Medical Device
Regulations (REGULATION (EU) 2017/745).
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
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)
1.9 EU Importer Information:
TRUMPF Medizin Systeme GmbH + Co. KG
Carl-Zeiss Straße 7-9
07318 Saalfeld/Saale
Germany
1.10 Australian sponsor Information:
Welch Allyn Australia Pty. Ltd.
Unit 4.01, 2-4 Lyonpark Road
Macquarie Park, NSW 2113
Phone [phone]

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2. System
2.1 System components Identification:
Allen® Traction Boot –Modular:
Modular Attachment for Steris® Systems:
Ratchet
Rotation Lock
Boot
Pads (6X)
Handles
(2X)
Straps
Buckle
(2X)
Boot Attachment
Plate
Table Attachment
Point

INSTRUCTIONS FOR USE
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ATB - Modular Attachment for Mizuho OSI ® Systems
2.2 Product Code and Description:
A-93005 - Allen Traction Boot - Modular
A-93006 - ATB- Modular Attach for Steris Systems
A-93007 - ATB- Modular Attach for Mizuho OSI Syss
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
Not Applicable
Not Applicable
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.
Name of Consumable
Product Number
Traction Boot Disposable
A-93001
Table Attachment
Point
Flexion / Extension
Lock
Boot Attachment
Plate

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2.4 Indication for use:
The Traction Boot 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 Traction Boot is designed to position, support and/or distract the patient’s 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, user
harm from functional, device damage or mechanical hazard cannot be
completely excluded.
3. Equipment 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.
Boot Assembly:
a. Loosen boot rotation knob and remove from
boot.

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b. Place Modular Attachment onto boot (Note:
Ensure rubber disk is on).
c. Tighten boot rotation knob onto boot and
tighten until secure.
Installing the Boot onto Mizuho OSI ® Systems:
a. Remove OSI ® Traction Boot (and
footplate, if present) from traction unit.
b. Fully insert Allen® Traction Boot for
Mizuho OSI ® Systems into traction unit.
OR

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c. Tighten top knob securely.
Installing the Boot onto Steris ® Systems:
a. Remove Steris® Traction Boot
(and footplate, if present) from
traction unit.
b. Fully insert Steris® Plate into
traction unit.
c. Tighten knob securely.

INSTRUCTIONS FOR USE
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Boot Preparation:
a. Loosen ratchet buckle by pulling
down on the tab and moving the
buckle to the bottom of the boot.
b. Loosen middle strap by pulling
outward.
c. Undo buckles and lay straps outside
of boot.

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3.2 Setup:
Disposable Usage:
a. Place disposable with ink side
down and place ankle on circle
cutout.
b. Wrap ankle section around patient
ankle and secure with Velcro®
strap.
c. Wrap calf section around patient
calf and secure with 2X Velcro®
straps.

INSTRUCTIONS FOR USE
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d. Wrap foot section around patient
foot and secure with Velcro® strap.
NOTE: If necessary, excess foam can be
removed by tearing perforations.

INSTRUCTIONS FOR USE
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Foot Placement:
a. Place foot in boot so dotted outline
on disposable sits directly on blue
pad.
b. Buckle middle buckle around ankle so
the strap is directly over the top of the
ankle.
c. Pull on lever of ratchet buckle and
tighten ankle strap until secure.

INSTRUCTIONS FOR USE
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d. Buckle toe and calf buckles and tighten
by pulling on the two straps.
Note: Check all connections of boot to ensure they are secure which is shown in red circles.
OSI ®
Steris
®