Arthrex AR-1627-15 User manual

Reusable Security Strap
Instructions for Use
Product No. AR-1627-15
80028278
Version B

INSTRUCTIONS FOR USE
Document Number: 80028278 Page 2 Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
ENGLISH ......................................................................................................................................... 3
БЪЛГАРСКИ ................................................................................................................................ 18
HRVATSKI ..................................................................................................................................... 33
ČESKÝ .......................................................................................................................................... 49
DANSK ......................................................................................................................................... 64
NEDERLANDS .............................................................................................................................. 79
EESTI ............................................................................................................................................. 95
SUOMI ........................................................................................................................................ 110
FRANÇAIS .................................................................................................................................. 125
DEUTSCH .................................................................................................................................... 141
ΕΛΛΗΝΙΚΑ ................................................................................................................................. 157
MAGYAR ................................................................................................................................... 173
ITALIANO ................................................................................................................................... 188
日本語版 .................................................................................................................................... 203
LATVISKI ..................................................................................................................................... 218
LIETUVIŲ ..................................................................................................................................... 233
NORSK ....................................................................................................................................... 248
POLSKI ........................................................................................................................................ 263
PORTUGUÊS ............................................................................................................................... 279
ROMÂNESC ............................................................................................................................... 294
SRPSKI ........................................................................................................................................ 310
SLOVENSKY ............................................................................................................................... 326
SLOVENŠČINA .......................................................................................................................... 342
ESPAÑOL ................................................................................................................................... 358
SVENSKA .................................................................................................................................... 373

INSTRUCTIONS FOR USE
Document Number: 80028278 Page 3 Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
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
Document Number: 80028278 Page 4 Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
Table of Contents
Reusasble Security Strap (AR-1627-15)
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:.................................................................................................. 9
EC authorized representative:.................................................................................... 9
Manufacturing Information:......................................................................................... 9
2System............................................................................................................................ 10
System components Identification:............................................................................10
Product Code and Description:..................................................................................10
List of Accessories and Consumable Components Table:.........................................10
Indication for use:......................................................................................................11
Intended use:............................................................................................................11
Residual risk: ............................................................................................................11
3Equipment Setup and Use: ........................................................................................... 11
Prior to use:...............................................................................................................11
Setup: .......................................................................................................................11
Device controls and indicators:..................................................................................13
Storage, Handling and Removal Instructions:............................................................14
3.4.1 Storage and Handling: ....................................................................................14
3.4.2 Removal Instruction: .......................................................................................14
Troubleshooting Guide:.............................................................................................14

INSTRUCTIONS FOR USE
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Version: B Ref Blank Template: 80025118 Ver. E
Device Maintenance:.................................................................................................14
4Safety Precautions and General Information: ............................................................ 14
General Safety Warnings and Cautions: ...................................................................14
Product Specifications:..............................................................................................15
Sterilization Instruction:.............................................................................................15
Cleaning and Disinfection Instruction: .......................................................................16
5List of Applicable Standards:........................................................................................ 16

INSTRUCTIONS FOR USE
Document Number: 80028278 Page 6 Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
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).

INSTRUCTIONS FOR USE
Document Number: 80028278 Page 7 Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
Contact Details:
For ordering information please see catalog.
Customer service
NA: 1-800-934-4404
INTL: [phone]
Address
1370 Creekside Blvd
Naples, FL 34108, USA
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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Version: B Ref Blank Template: 80025118 Ver. E
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
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

INSTRUCTIONS FOR USE
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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)
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)

INSTRUCTIONS FOR USE
Document Number: 80028278 Page 10 Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
2System
System components Identification:
Product Code and Description:
AR-1627-15 - Reusable Security Strap
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.
Name of Consumable
Product Number
Not Applicable
Not Applicable
Plastic Clasp
Strap Loop

INSTRUCTIONS FOR USE
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Indication for use:
The Security Strap is used in a variety of surgical procedures including, but not
limited to orthopedic surgery in beach chair position. These devices are capable
of being used with a broad patient population as determined appropriate by the
caregiver or institution.
Intended use:
The Security Strap is designed to safely hold the patient’s arm in a variety of
surgical procedures including, but not limited to orthopedic surgery in beach
chair position. 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 hazards cannot be
completely excluded.
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:
Equipment Setup
1. Unclip plastic clasp of Lap Restraint, BC.
Plastic Clasp

INSTRUCTIONS FOR USE
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2. Take shorter strap and insert the looped
end in the gap on the left-hand side
between the Backboard and the
Backboard Hinge Pin. Thread through
from underneath.
3. Insert the clasp end of the shorter strap
into the loop end and gently pull until
the strap is tightly looped around the
Backboard Hinge Pin.
Repeat steps 2-3 with the longer strap
on the right-hand side.
4. Feed clasp end of longer strap through
large loop in Padded Wrist Support.
5. Clasp two straps.
Looped End
Padded Wrist
Support

INSTRUCTIONS FOR USE
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6. Tighten Strap.
7. Store excess strap and pad as shown.
Equipment Use
1. Fasten Security Strap around the
patient’s waist, after raising the
patient into the Beach Chair
position.
2. Place the non-operative arm in the
wrist cuff.
Device controls and indicators:
Controls and indicators of this device are described within the Setup instructions.

INSTRUCTIONS FOR USE
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Version: B Ref Blank Template: 80025118 Ver. E
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. Unstrap patient arm.
2. Unclip plastic clasp and unwind strap from the beach chair.
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 Allen Medical Systems, Inc. if you need to repair or replace the device
contact us 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.
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. To prevent patient and/or user injury and/or equipment damage, verify the
device attaching clamps completely touch the table-side rails and are firmly in
place. Apply device only to U.S. standard side rails. Test the locking mechanism
to ensure no movement when elevated or pushed.

INSTRUCTIONS FOR USE
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CAUTION:
a. Do not exceed safe working load shown in the product specification table
b. To prevent patient and/or user injury and /or equipment damage: all
modifications, upgrades, or repairs must be performed by an Allen authorized
specialist. Failure to comply may void warranty.
c. Do not raise or lower the shoulder chair when the safety strap is attached.
Product Specifications:
Note: Consult the corresponding IFU for the products mentioned in the above table.
Sterilization Instruction:
This device is not intended to be sterilized. Equipment damage may occur.
Mechanical Specifications
Description
Product Dimensions
Strap: 85” long (216 cm)
Pad: 11.5” x 7” (29.2 cm x 18 cm)
Material
DARTEX and Nylon
Safe Working Load on the device
500 lbs. patient (226 kg)
Overall Weight of Complete Device
Approx. 1 lbs. (0.45 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 Counter Traction Strap is
compatible with:
Beach Chair Positioner
AR-1627-16
AR-1627-16W

INSTRUCTIONS FOR USE
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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
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

Reusable Security Strap
Инструкции за употреба
Продуктов № AR-1627-15
80028278
Version B

ИНСТРУКЦИИ ЗА УПОТРЕБА
Document Number: 80028278 Страница 18 Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
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 с
пациент се препоръчва да прочетете инструкциите за
употреба и да се запознаете с продукта.

ИНСТРУКЦИИ ЗА УПОТРЕБА
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Version: B Ref Blank Template: 80025118 Ver. E
Съдържание
Reusable Security Strap (AR-1627-15)
1Обща информация.................................................................................................... 21
Съобщение за авторското право:...........................................................................21
Търговски марки:.....................................................................................................21
Данни за контакт:.....................................................................................................22
Съображения за безопасност:................................................................................22
1.4.1 Съобщение за символа за риск за безопасността: .....................................22
1.4.2 Съобщение за неправилно използване на оборудването: .........................22
1.4.3 Съобщение за потребителите и/или пациентите: .......................................22
1.4.4 Безопасно изхвърляне:.................................................................................22
Работа със системата:............................................................................................23
1.5.1 Приложими символи: ....................................................................................23
1.5.2 Целева потребителска и пациентска популация:........................................24
1.5.3 Съответствие с регламентите за медицински изделия: .............................24
Съображения за ЕМС: ............................................................................................24
Упълномощен представител за ЕО:.......................................................................24
Производствена информация:................................................................................24
2Система ....................................................................................................................... 25
Идентификация на компонентите на системата:...................................................25
Код и описание на продукта:...................................................................................25
Списък с аксесоарите и таблица с консумативи: ..................................................25
Показание за употреба: ..........................................................................................26
Предназначение:.....................................................................................................26
Остатъчен риск:.......................................................................................................26
3Настройване и използване на оборудването:...................................................... 26
Преди употреба:......................................................................................................26
Настройване:...........................................................................................................26
Контролни елементи и индикатори на изделието: ................................................28
Инструкции за съхранение, боравене и отстраняване:.........................................29
3.4.1 Съхранение и боравене:...............................................................................29
3.4.2 Инструкция за сваляне: ................................................................................29
Ръководство за отстраняване на неизправности: .................................................29

ИНСТРУКЦИИ ЗА УПОТРЕБА
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Поддръжка на изделието:.......................................................................................29
4Предпазни мерки за безопасност и обща информация: .................................. 29
Общи предупреждения за безопасност и сигнали за внимание:..........................29
Спецификации на продукта: ...................................................................................30
Инструкция за стерилизиране: ...............................................................................30
Инструкция за почистване и дезинфекция: ...........................................................31
5Списък с приложимите стандарти: ........................................................................ 31