Hillrom A-90001 User manual

Counter Traction Brace
Instructions for Use
Product No. A-90001
80028153
Version C

INSTRUCTIONS FOR USE
Document Number: 80028153 Page 2 Issue Date: 30 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
ENGLISH ............................................................................................................................................3
中文简体 ......................................................................................................................................... 18
中文繁體 ......................................................................................................................................... 33
FRANÇAIS ...................................................................................................................................... 49
DEUTSCH........................................................................................................................................ 64
BAHASA INDONESIA..................................................................................................................... 79
ITALIANO........................................................................................................................................ 94
日本語版 ....................................................................................................................................... 109
한국어 ................................................................................................................123
LATVISKI........................................................................................................................................ 138
POLSKI .......................................................................................................................................... 152
PORTUGUÊS ................................................................................................................................. 168
ROMÂNESC ................................................................................................................................. 183
SRPSKI........................................................................................................................................... 198
SLOVENSKY.................................................................................................................................. 213
SLOVENŠČINA............................................................................................................................. 228
ESPAÑOL...................................................................................................................................... 243
TIẾNG VIỆT.................................................................................................................................................. 258

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® Counter Traction Brace (90001)
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
1.10Authorised Australian sponsor:..................................................................................10
2. System..................................................................................................................................11
2.1 System components Identification: .........................................................................11
2.2 Product Code and Description:...............................................................................11
2.3 List of Accessories and Consumable Components Table:...................................11
2.4 Indication for use:.......................................................................................................12
2.5 Intended use: ..............................................................................................................12
3. Equipment Setup and Use:...............................................................................................12
3.1 Prior to use: ..................................................................................................................12
3.2 Setup: ...........................................................................................................................12
3.3 Device controls and indicators: ...............................................................................12
3.4 Storage, Handling and Removal Instructions: ........................................................13
3.4.1 Storage and Handling:....................................................................................13

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3.4.2 Removal Instruction: ........................................................................................13
3.5 Troubleshooting Guide: .............................................................................................13
3.6 Device Maintenance:................................................................................................13
4. Safety Precautions and General Information:...............................................................13
4.1 General Safety Warnings and Cautions:.................................................................13
4.2 Product Specifications:..............................................................................................14
4.3 Sterilization Instruction:...............................................................................................14
4.4 Cleaning and Disinfection Instruction: ....................................................................15
5. List of Applicable Standards:............................................................................................15

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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]

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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

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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:
Baxter Medical Systems GmbH + Co. KG
Carl-Zeiss Straße 7-9
07318 Saalfeld/Saale
Germany
1.10 Authorised Australian sponsor:
Welch Allyn Australia Pty. Ltd.
1 Baxter Drive
Old Toongabbie, NSW 2146
Australia

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2. System
2.1 System components Identification:
2.2 Product Code and Description:
A-90001 - Counter Traction Brace
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
Accessory Cart
A-30010 (US Rail), A-30010E (EU Rail),
A-30010UK (UK Rail), A-30010J (Japan Rail)
Note: Consult the corresponding IFU for the products mentioned in the above table.
Name of Consumable
Product Number
Not applicable
Not applicable
Circular
Support
Head
Mounting Post
Easy Lock Socket
Knob

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2.4 Indication for use:
The Counter Traction Brace is used in a variety of surgical procedures including, but
not limited to orthopedic surgery while traction is applied to the arm of the operative
side. 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 Counter Traction Brace is designed to safely hold the patient’s torso and arm in a
variety of surgical procedures including, but not limited to orthopedic surgery while
traction is applied to the arm of the operative side. These devices are intended to be
used by healthcare professionals within the Operating Room setting.
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.
3.2 Setup:
a. The patient should be safely positioned in the Allen Beach Chair prior to
installation.
b. Position the table socket to the operative side of the table with the Easy Lock®
Socket (included). Align the socket with the patient's hip.
c. Insert the mounting post into the socket.
d. Position the circular support head under the operative arm and against the
patient's rib cage, slightly below the nipple line of the patient.
e. Secure the Easy Lock®Socket knob.
3.3 Device controls and indicators:
Controls and indicators of this device are described within the Setup instructions.

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3.4 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 4.2
3.4.2 Removal Instruction:
a. Loosen the Easy Lock Socket knob.
b. Remove the mounting post from the Easy Lock Socket.
3.5 Troubleshooting Guide:
This device does not have a troubleshooting guide. For technical support user of the
device shall first contact Hill-Rom Technical Support.
3.6 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).
4. Safety Precautions and General Information:
4.1 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.

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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.
4.2 Product Specifications:
Note: Consult the corresponding IFU for the products mentioned in the above table.
4.3 Sterilization Instruction:
This device is not intended to be sterilized. Equipment damage may occur.
Mechanical Specifications
Description
Product Dimensions
13” x 2.5” x 24” (33cm x 6.4cm x 61cm)
Material
Stainless Steel, Aluminum, Nylon,
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
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 Brace is
compatible with:
Post size 11/16" (1.8 cm) and easy lock
socket to OR table rail.

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4.4 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
5. 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
6.
IEC 60601-2-46
Medical electrical equipment - Part 2-46: Particular
requirements for the basic safety and essential
performance of operating tables

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Sl. no
Standards
Description
7.
ISTA
International Safe Transit Association standards for
package testing

Counter Traction Brace
使用说明
产品编号 A-90001
80028153
Version C

使用说明
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重要通知
•将设备用于患者之前，请先阅读并了解本手册中以及设备上的所有警告。
•符号用于提醒用户注意有关使用本设备的一些重要操作规程或安全说明。
标签上的 符号旨在提示使用中何时应参考 IFU。
•本手册中详细介绍的技术仅作为制造商的建议。使用本设备进行患者治疗的最终责
任仍由主治医师承担。
•每次使用之前，应检查设备功能。
•本设备只应由接受过培训的人员操作。
•任何修改、升级或维修都必须由经过授权的专业人员执行。
•请务必保存好本手册，以备日后参考。
•如果出现与设备相关的严重事故，应立即报告制造商和本文档所列的主管机构。
将本设备或其他类型的医疗设备用于患者前，建议阅读 使用说明 并熟悉产
品。

使用说明
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目录
Allen™ Counter Traction Brace (90001)
1. 一般信息：............................................................................................................................21
1.1 版权声明： ....................................................................................................................21
1.2 商标： ...........................................................................................................................21
1.3 联系信息： ....................................................................................................................22
1.4 安全注意事项：.............................................................................................................22
1.4.1 安全危险符号说明：...........................................................................................22
1.4.2 设备误用声明： ..................................................................................................22
1.4.3 用户和/或患者注意事项：..................................................................................22
1.4.4 安全处置：..........................................................................................................23
1.5 操作系统： ....................................................................................................................23
1.5.1 适用符号：..........................................................................................................23
1.5.2 目标用户和患者群体： .......................................................................................24
1.5.3 符合医疗设备规定：...........................................................................................25
1.6 EMC 注意事项：...........................................................................................................25
1.7 EC 授权代表： ..............................................................................................................25
1.8 制造信息： ....................................................................................................................25
1.9 欧盟进口商信息： .........................................................................................................25
1.10授权的澳大利亚赞助商： ..............................................................................................25
2. 系统.......................................................................................................................................26
2.1 系统组件标识：.............................................................................................................26
2.2 产品代码和说明： .........................................................................................................26
2.3 附件列表和耗材组件表： ..............................................................................................26
2.4 使用适应症： ................................................................................................................27

使用说明
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2.5 预期用途： ....................................................................................................................27
3. 设备安装和使用：.................................................................................................................27
3.1 使用前：........................................................................................................................27
3.2 安装： ...........................................................................................................................27
3.3 设备控件和指示器： .....................................................................................................27
3.4 存放、搬运和拆卸说明： ..............................................................................................28
3.4.1 存放和搬运：......................................................................................................28
3.4.2 拆卸说明：..........................................................................................................28
3.5 故障排除指南：.............................................................................................................28
3.6 设备维护： ....................................................................................................................28
4. 安全注意事项和一般信息：..................................................................................................28
4.1 一般安全警告和警示：..................................................................................................28
4.2 产品规格： ....................................................................................................................29
4.3 灭菌说明： ....................................................................................................................30
4.4 清洁和消毒说明： .........................................................................................................30
5. 适用标准列表： ....................................................................................................................30