Steris 10009192 User manual

Traction Boot Assembly
Instructions for Use
Product No. 10009192
80028294
Version A

INSTRUCTIONS FOR USE
Document Number: 80028294 Page 2 Issue Date: 31 MAR 2020
Version: A Ref Blank Template: 80025118 Ver. E
ENGLISH.......................................................................................................................................... 3
БЪЛГАРСКИ................................................................................................................................. 20
ČESKÝ ........................................................................................................................................... 38
DANSK .......................................................................................................................................... 55
NEDERLANDS ............................................................................................................................... 72
EESTI .............................................................................................................................................. 90
SUOMI......................................................................................................................................... 107
FRANÇAIS................................................................................................................................... 124
DEUTSCH..................................................................................................................................... 141
ΕΛΛΗΝΙΚΑ .................................................................................................................................. 158
MAGYAR .................................................................................................................................... 176
ITALIANO .................................................................................................................................... 193
LATVISKI ...................................................................................................................................... 210
NORSK ........................................................................................................................................ 227
POLSKI......................................................................................................................................... 244
PORTUGUÊS................................................................................................................................ 262
ROMÂNESC................................................................................................................................ 280
SRPSKI ......................................................................................................................................... 297
SLOVENSKY ................................................................................................................................ 314
SLOVENŠČINA ........................................................................................................................... 331
ESPAÑOL .................................................................................................................................... 348
SVENSKA..................................................................................................................................... 365

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
Steris® Traction Boot Assembly (10009192)
1General Information........................................................................................................... 6
Copyright Notice:........................................................................................................ 6
Trademarks:............................................................................................................... 6
Contact Details:.......................................................................................................... 7
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:....................................................................................................... 7
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:........................................................ 9
EMC considerations:.................................................................................................10
EC authorized representative:...................................................................................10
Manufacturing Information:........................................................................................10
2System.............................................................................................................................10
System components Identification:............................................................................10
Product Code and Description:..................................................................................10
List of Accessories and Consumable Components Table:.........................................11
Indication for use:......................................................................................................11
Intended use:............................................................................................................11
Residual risk: ............................................................................................................11
3Equipment Setup and Use:...............................................................................................12
Prior to use:...............................................................................................................12
Setup: .......................................................................................................................12
Device controls and indicators:..................................................................................14
Storage, Handling and Removal Instructions:............................................................14
3.4.1 Storage and Handling:........................................................................................ 14
3.4.2 Removal Instruction:........................................................................................... 14
Troubleshooting Guide:.............................................................................................15

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Device Maintenance:.................................................................................................15
4Safety Precautions and General Information:...................................................................15
General Safety Warnings and Cautions: ...................................................................15
Product Specifications:..............................................................................................16
Sterilization Instruction:.............................................................................................17
Cleaning and Disinfection Instruction: .......................................................................17
5List of Applicable Standards:............................................................................................17

INSTRUCTIONS FOR USE
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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.
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.
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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Contact Details:
For complains or ordering information, please contact your supplier and refer to
the catalog. All modifications, upgrades, or repairs must be performed by an
authorized specialist.
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
1.4.4 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.

INSTRUCTIONS FOR USE
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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
Indicates the manufacturer’s
catalogue number
EN ISO 15223-1

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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
1.5.3 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)

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EMC considerations:
This is not an electromechanical device. Therefore, EMC Declarations are not
applicable.
EC authorized representative:
HILL-ROM SAS
B.P. 14 - Z.I. DU TALHOUET
56330 PLUVIGNER
FRANCE
TEL: [phone]
Manufacturing Information:
ALLEN MEDICAL SYSTEMS, INC.
100 DISCOVERY WAY
ACTON, MA 01720 USA
800-433-5774 (NORTH AMERICA)
978-266-4200 (INTERNATIONAL)
2System
System components Identification:
Product Code and Description:
10009192 - Boot Assembly, Traction Device,OT 1000
Buckle (3X)
Boot
Handle (2X)
Straps

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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.
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.
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.
Residual risk:
This product complies with relevant performance, safety standards. However,
device or patient harm from misuse or device damage hazard cannot be
completely excluded.
Name of Consumable
Product Number
Traction Boot Disposable Pad
10020079

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3Equipment Setup and Use:
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.
Setup:
Fasten patient in Traction
Boot Assembly as follows:
1. Position boot on a flat
surface.
2. Loosen middle strap by
releasing strap ratchet
assembly (back of boot)
and lowering to bottom of
boot. Pull outward on strap
(see Figure 1).
3. Open three buckles (by
squeezing tabs) and lay
straps over exterior of boot
(see Figure 2).
Figure 1. Loosen Middle Strap (Typical)
Figure 2. Unlatch and Open Boot Straps

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4. Place patient’s foot in
Traction Boot Disposable Pad
(10020079) as follows (see
Figure 3):
a. Review printed
instructions on Traction
Boot Disposable Pad (see
Figure 4).
b. Position Pad under patient’s
foot, instructions down and
heel positioned at opening
(see Figure 5).
Figure 3. Traction Boot Disposable Pad
(Typical)
Figure 4. Disposable Pad Instructions (Typical)
Figure 5. Position Foot on Disposable Pad
(Typical)

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c. Fold pad against bottom of foot.
d. Wrap section number 1 over patient ankle. Then wrap section number 2
over section number 1 and secure with hook-and-loop strap.
e. Wrap section number 3 over patient calf. Then wrap section number 4 over
section number 3 and secure with hook-and-loop strap.
f. Lastly, secure upper ankle by folding section 5 over previous folded sections
and fastening with hook-and-loop strap.
5. Positioned padded foot into Traction Boot Assembly as follows.
a. Place patient foot into boot so heel rests on pad in boot.
b. Buckle middle strap. Ensure strap is directly over top of ankle.
c. At rear of boot, tighten middle strap using strap ratchet assembly until ankle
is secure.
d. Buckle toe and calf straps and tighten by pulling slack straps.
Device controls and indicators:
Controls and indicators of this device are described within the Setup instructions.
Storage, Handling and Removal Instructions:
3.4.1 Storage and Handling:
The product should be stored in a clean and safe environment to prevent product
damage. See storage Specifications under Product Specification section.
3.4.2 Removal Instruction:
1. Unbuckle straps around the toe,
ankle, and calf.

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2. Lift foot out of boot.
3. Device may be stored
with table or removed
per table Instructions.
Troubleshooting Guide:
This device does not have a troubleshooting guide. For technical support users of
the device shall first contact their supplier.
Device Maintenance:
Make sure that all labels are installed and can be read. Replace labels as
necessary by using a plastic scraper to remove the label. Use an alcohol wipe to
remove any adhesive residue.
Contact us if you need to repair or replace the device by using the information
from the contact details section (1.3).
4Safety Precautions and General Information:
General Safety Warnings and Cautions:
WARNING:
a. Do not use if product shows visible damage.
b. Prior to using this device, please read the instructions for equipment set up and
use. Familiarize yourself with the product before application on a patient.

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c. To prevent patient and/or user injury and/or equipment damage, examine the
device and surgical-table side rails for potential damage or wear prior to use. Do
not use the device if damage is visible, if parts are missing or if it does not function
as expected.
d. Do not exceed 75 lbs. Traction load limit.
e. Fits Shoe Sizes: US W5 to M14 (EU W35 to M48-1/2; UK W2-1/2 to M13-1/2; JP W21
to M31.5).
f. To reduce the chances of patient tissue damage, care should be taken to ensure
proper orientation and location of padding.
CAUTION:
Do not exceed safe working load shown in the product specification table
Product Specifications:
Note: Consult the corresponding IFU for the products mentioned in the above table.
Mechanical Specifications
Description
Product Dimensions
8" x 17 "x 14" (20.3cm x 43.2cm x 35.5cm)
Material
Black Acetal, 6061-T6 ALUMINUM, Nylon,
BLACK PVC VINYL
Safe Working Load on the device
500 lbs. (226 kg)
Overall Weight of Complete Device
4 lbs. (1.8 kg)
Storage Specifications
Description
Storage temperature
-29ᵒC to +60ᵒC
Storage Relative humidity range
15% to 85%
Operating temperature
This device is intended to be used in a
controlled Operating Room environment.
Operating Relative humidity range
Electrical Specifications
Description
Not Applicable.
Not Applicable.
Software Specifications
Description
Not Applicable.
Not Applicable.
Compatibility Specifications
Description
The Steris®Traction Boot is compatible
with:
OT 1000 Orthopedic Table
OT 1100 Orthopedic Table
OT 1200 Orthopedic Table (

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Sterilization Instruction:
This device is not intended to be sterilized. Equipment damage may occur.
Cleaning and Disinfection Instruction:
WARNING:
Do not use bleach or products that contain bleach to clean the device. Injury or
equipment damage can occur.
After each use, clean the device with alcohol-based wipes.
Do not put the device into water. Equipment damage can occur.
Use a cloth and a quaternary ammonium disinfecting/cleaning solution to clean
and disinfect the device.
Read and follow the manufacturer’s recommendation for low-level disinfection.
Read and follow the cleaning product’s instructions. Use caution in areas where
liquid can get into the mechanism.
Wipe the device with a clean, dry cloth.
Make sure that the device is dry before you store it or use it again.
CAUTION: DO NOT IMMERSE PADS IN ANY LIQUID
CAUTION: DO NOT USE BLEACH OR PHENOLICS ON PADS
5List of Applicable Standards:
Sl. no
Standards
Description
1.
EN 62366-1
Medical devices - Part 1: Application of usability
engineering to medical devices
2.
EN ISO 14971
Medical devices- Application of risk management to
medical devices.
3.
EN 1041
Information supplied by the manufacturer of
medical devices
4.
EN ISO 15223-1
Medical devices - Symbols to be used with medical
device labels, labelling and information to be
supplied - Part 1: General requirements
5.
EN ISO 10993-1
Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management
process

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Sl. no
Standards
Description
6.
IEC 60601-2-46
Medical electrical equipment - Part 2-46: Particular
requirements for the basic safety and essential
performance of operating tables
7.
ISTA
International Safe Transit Association standards for
package testing

Traction Boot Assembly
Инструкции за употреба
Продуктов № 10009192
80028294
Version A

ИНСТРУКЦИИ ЗА УПОТРЕБА
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ВАЖНИ СЪОБЩЕНИЯ
•Прочетете и разберете всички предупреждения в това ръководство и по
самото изделие, преди да го използвате с пациент.
•Символът е предназначен да сигнализира на потребителя за
важни процедури или инструкции за безопасност относно
използването на това изделие.
Символът на етикетите е предназначен да показва кога трябва
да се направи справка с инструкциите за употреба (IFU) за
употребата.
•Техниките, описани в това ръководство, са само предложения на
производителя. Окончателната отговорност за грижи за пациента по
отношение на това изделие остава при лекуващия лекар.
•Функцията на изделието трябва да се проверява преди всяка употреба.
•С това изделие трябва да работи единствено обучен персонал.
•Всички модификации, надстройки или ремонти трябва да се
извършват от упълномощен специалист.
•Дръжте това ръководство налично за бъдеща справка.
•Всеки един сериозен инцидент, възникнал във връзка с изделието,
трябва да се докладва на производителя и на компетентния орган,
посочен в този документ.
Преди използването на този или друг тип медицински апарат
спациент се препоръчва да прочетете инструкциите за
употреба и да се запознаете с продукта.