Arthrex AR-1627-01 User manual

Lateral & Prone Arm Support
Instructions for Use
Product No. AR-1627-01
80028276
Version B

INSTRUCTIONS FOR USE
Document Number: 80028276 Page 2 Issue Date: 31 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
ENGLISH ......................................................................................................................................... 3
БЪЛГАРСКИ ................................................................................................................................ 18
HRVATSKI ..................................................................................................................................... 33
ČESKÝ .......................................................................................................................................... 48
DANSK ......................................................................................................................................... 63
NEDERLANDS .............................................................................................................................. 78
EESTI ............................................................................................................................................. 93
SUOMI ........................................................................................................................................ 108
FRANÇAIS .................................................................................................................................. 123
DEUTSCH .................................................................................................................................... 138
ΕΛΛΗΝΙΚΑ ................................................................................................................................. 154
MAGYAR ................................................................................................................................... 170
ITALIANO ................................................................................................................................... 185
日本語版 .................................................................................................................................... 201
LATVISKI ..................................................................................................................................... 216
LIETUVIŲ ..................................................................................................................................... 231
NORSK ....................................................................................................................................... 246
POLSKI ........................................................................................................................................ 261
PORTUGUÊS ............................................................................................................................... 276
ROMÂNESC ............................................................................................................................... 291
SRPSKI ........................................................................................................................................ 307
SLOVENSKY ............................................................................................................................... 322
SLOVENŠČINA .......................................................................................................................... 337
ESPAÑOL ................................................................................................................................... 352
SVENSKA .................................................................................................................................... 367

INSTRUCTIONS FOR USE
Document Number: 80028276 Page 3 Issue Date: 31 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: 80028276 Page 4 Issue Date: 31 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
Table of Contents
Lateral & Prone Arm Support (AR-1627-01)
General Information........................................................................................................... 6
Copyright Notice:........................................................................................................ 6
Trademarks:............................................................................................................... 6
Contact Details:.......................................................................................................... 6
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:........................................................................................10
System.............................................................................................................................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
Equipment Setup and Use:...............................................................................................11
Prior to use:...............................................................................................................11
Setup: .......................................................................................................................12
Device controls and indicators:..................................................................................13
Storage, Handling and Removal Instructions:............................................................13
3.4.1 Storage and Handling: ....................................................................................13
3.4.2 Removal Instruction: .......................................................................................13
Troubleshooting Guide:.............................................................................................13
Device Maintenance:.................................................................................................13

INSTRUCTIONS FOR USE
Document Number: 80028276 Page 5 Issue Date: 31 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
Safety Precautions and General Information:...................................................................14
General Safety Warnings and Cautions: ...................................................................14
Product Specifications:..............................................................................................14
Sterilization Instruction:.............................................................................................15
Cleaning and Disinfection Instruction: .......................................................................15
List of Applicable Standards:............................................................................................16

INSTRUCTIONS FOR USE
Document Number: 80028276 Page 6 Issue Date: 31 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
General Information
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).
Contact Details:
For ordering information please see catalog.
customer service Information:
Address:
1370 Creekside Blvd
Naples, FL 34108
NA: 1-800-934-4404
INTL: [phone]
International
North America

INSTRUCTIONS FOR USE
Document Number: 80028276 Page 7 Issue Date: 31 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
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
Document Number: 80028276 Page 8 Issue Date: 31 MAR 2020
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 (2 digests)
indicates the date of the year (3 digits)
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

INSTRUCTIONS FOR USE
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Version: B Ref Blank Template: 80025118 Ver. E
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)
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]

INSTRUCTIONS FOR USE
Document Number: 80028276 Page 10 Issue Date: 31 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
Manufacturing Information:
ALLEN MEDICAL SYSTEMS, INC.
100 DISCOVERY WAY
ACTON, MA 01720 USA
800-433-5774 (NORTH AMERICA)
978-266-4200 (INTERNATIONAL)
System
System components Identification:
Product Code and Description:
AR-1627-01- LPS Arm Support
Pivoting Block Handle
Support Rod (post)

INSTRUCTIONS FOR USE
Document Number: 80028276 Page 11 Issue Date: 31 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
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
Accessory Cart
F-30010 (US Rail), F-30010E (EU Rail),
F-30010UK (UK Rail)
Note: Consult the corresponding IFU for the products mentioned in the above table.
Indication for use:
The Arm Support is used in a variety of surgical procedures including, but not limited
to spine and shoulder surgery that requires supine, prone and/or beach chair
positioning. These devices are capable of being used with a broad patient
population as determined appropriate by the caregiver or institution.
Intended use:
The Arm Support is designed to position and support the patient’s arm in a variety of
surgical procedures including, but not limited to spine and shoulder surgery that
requires supine, prone and/or beach chair positioning. These devices are intended
to be used by healthcare professionals within the Operating Room setting.
Equipment 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.
Name of Consumable
Product Number
Not Applicable
Not Applicable

INSTRUCTIONS FOR USE
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Version: B Ref Blank Template: 80025118 Ver. E
Setup:
a. The patient should be
safely positioned on the
table and secured
accordingly.
b. Place the arm board post
into a clamp/socket that is
positioned appropriately
on the table siderail.
a. Once the Arm Support is
placed in the clamp and
the desired positioning is
achieved (based on the
position of the arm board
and clamp/socket as it
relates to the orientation
of the patient), you can
secure the clamp/socket
to the table by tightening
the knob.
Patient Positioning
a. Once the patient is safely supported in the desired position, place the arm on
the padded Arm Support. Use the straps to secure the patient's arm to the
surface as needed.
b. Fine adjustments of the height of the Arm Support may be made by
supporting the patient's arm while loosening the post in the clamp/socket.
When properly positioned, the patient's arm will rest gently on the Arm Support
and the palm of the hand will “cup” the palm support. The arm is then
balanced in a passive, anatomically correct position. Be sure to re-tighten the
clamp/socket.
c. Further adjustments can be performed by repeating the above step in
addition to loosening the Pivoting Block Handle and repositioning the patient's
arm accordingly. Once the desired positioning has been achieved, be sure to
re-tighten all knobs and clamps/sockets.

INSTRUCTIONS FOR USE
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Version: B Ref Blank Template: 80025118 Ver. E
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.
3.4.2 Removal Instruction:
a. Safely Remove the Arm of the patient from the LPS Arm Support.
b. Remove the arm board post from the clamp/socket.
c. Remove the clamp/socket from the table by loosening the knob 2.
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).
Knob 2
Knob 1

INSTRUCTIONS FOR USE
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Version: B Ref Blank Template: 80025118 Ver. E
Safety 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. Test the locking mechanism to ensure no movement when elevated or
pushed.
CAUTION:
a. 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.
b. Do not exceed safe working load shown in the product specification table.
Product Specifications:
Mechanical Specifications
Description
Product Dimensions
Support Rod (post):
Long section: 50.8 cm (20”)
Short Section: 20.3 cm (8”)
Armboard length: 30.5 cm (12”)
Armboard width: 9.2 cm (3.6)
Material
Stainless Steel, Nylon, Aluminum, Bronze,
Engineering Polymers
Safe Working Load on the device
500 lbs.(226 kg)
Overall Weight of Complete Device
<44 lbs. (20 kg)
Storage Specifications
Description
Storage temperature
-29ᵒC to +60ᵒC

INSTRUCTIONS FOR USE
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Version: B Ref Blank Template: 80025118 Ver. E
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.
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
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 LPS Arm Support is compatible with:
Clip-OnTM Socket, or equivalent Clamp

INSTRUCTIONS FOR USE
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Version: B Ref Blank Template: 80025118 Ver. E
List 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
8
IEC 60601-2-46
Medical electrical equipment - Part 2-46:
Particular requirements for the basic safety
and essential performance of operating tables
9
ISTA
International Safe Transit Association standards
for package testing

Lateral & Prone Arm Support
Инструкции за употреба
Продуктов № AR-1627-01
80028276
Version B

ИНСТРУКЦИИ ЗА УПОТРЕБА
Document Number: 80028276 Страница 18 Issue Date: 31 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
Lateral & Prone Arm Support (AR-1627-01)
Обща информация .........................................................................................................21
Съобщение за авторското право:...........................................................................21
Търговски марки:.....................................................................................................21
Данни за контакт:.....................................................................................................21
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:................................................................................25
Система...........................................................................................................................25
Идентификация на компонентите на системата:...................................................25
Код и описание на продукта:...................................................................................25
Списък с аксесоарите и таблица с консумативи: ..................................................26
Показание за употреба: ..........................................................................................26
Предназначение:.....................................................................................................26
Настройване и използване на оборудването:...............................................................26
Преди употреба:......................................................................................................26
Настройване:...........................................................................................................27
Контролни елементи и индикатори на изделието: ................................................28
Инструкции за съхранение, боравене и отстраняване:.........................................28
3.4.1 Съхранение и боравене:...............................................................................28
3.4.2 Инструкция за сваляне: ................................................................................28
Ръководство за отстраняване на неизправности: .................................................28
Поддръжка на изделието:.......................................................................................28

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