Hillrom A-90001 Istruzioni per l'uso

Counter Traction Brace

Instructions for Use

Product No. A-90001

80028153

Version C

INSTRUCTIONS FOR USE         
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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) 
General Information: ........................................................................................................... 6 
1 Copyright Notice: ......................................................................................................... 6 
2 Trademarks: ................................................................................................................... 6 
3 Contact Details: ............................................................................................................ 7 
4 Safety Considerations: ................................................................................................. 7 
4.1 Safety hazard symbol notice: ........................................................................... 7 
4.2 Equipment misuse notice: ................................................................................. 7 
4.3 Notice to users and/or patients: ...................................................................... 7 
4.4 Safe disposal: ...................................................................................................... 8 
5 Operating the system: ................................................................................................. 8 
5.1 Applicable Symbols: .......................................................................................... 8 
5.2 Intended User and Patient Population: .......................................................... 9 
5.3 Compliance with medical device regulations: ........................................... 10 
6 EMC considerations: .................................................................................................. 10 
7 EC authorized representative: .................................................................................. 10 
8 Manufacturing Information: ...................................................................................... 10 
9 EU Importer Information: ............................................................................................ 10 
10 Authorised Australian sponsor: .................................................................................. 10 
System .................................................................................................................................. 11 
1 System components Identification: ......................................................................... 11 
2 Product Code and Description: ............................................................................... 11 
3 List of Accessories and Consumable Components Table: ................................... 11 
4 Indication for use: ....................................................................................................... 12 
5 Intended use: .............................................................................................................. 12 
Equipment Setup and Use: ............................................................................................... 12 
1 Prior to use: .................................................................................................................. 12 
2 Setup: ........................................................................................................................... 12 
3 Device controls and indicators: ............................................................................... 12 
4 Storage, Handling and Removal Instructions: ........................................................ 13 
4.1 Storage and Handling: .................................................................................... 13 

INSTRUCTIONS FOR USE         
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4.2 Removal Instruction: ........................................................................................ 13 
5 Troubleshooting Guide: ............................................................................................. 13 
6 Device Maintenance: ................................................................................................ 13 
Safety Precautions and General Information: ............................................................... 13 
1 General Safety Warnings and Cautions:................................................................. 13 
2 Product Specifications: .............................................................................................. 14 
3 Sterilization Instruction: ............................................................................................... 14 
4 Cleaning and Disinfection Instruction: .................................................................... 15 
List of Applicable Standards: ............................................................................................ 15 
 
  

INSTRUCTIONS FOR USE

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1. General Information:

Allen Medical Systems, Inc. is a subsidiary of Hill-Rom, Inc., (NYSE: HRC), a leading

worldwide manufacturer and provider of medical technologies and related services

for the health care industry. As an industry leader in patient positioning, our passion is

improving patient outcomes and caregiver safety, while enhancing our customers'

efficiency. Our inspiration comes from providing innovative solutions to address our

customers' most pressing needs. We immerse ourselves in our customers' world, to

better address these needs and the daily challenges of their environment. Whether

developing a solution to address patient positioning challenges or creating a system

to offer safe and effective surgical site access for the surgical team, we are committed

to providing products of exceptional value and quality.

Allen products are backed by responsive and reliable service and complimentary on-

site product demonstrations.

1.1 Copyright Notice:

Revision

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).

INSTRUCTIONS FOR USE

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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

(800) 433-5774

+1 978 266 4200 ext.4286

(978) 263-8846

+1 978 266 4426

INSTRUCTIONS FOR USE

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1.4.4 Safe disposal:

Customers should adhere to all federal, state, regional, and/or local laws and

regulations as it pertains to the safe disposal of medical devices and accessories. If in

doubt, the user of the device shall first contact Hill-Rom Technical Support for

guidance on safe disposal protocols.

1.5 Operating the system:

1.5.1 Applicable Symbols:

Symbol used

Description

Reference

Indicates the device is a medical device

MDR 2017/745

Indicates the medical device

manufacturer

EN ISO 15223-1

Indicates the manufacturer’s serial

number. The device serial number is

encoded as 1YYWWSSSSSSS.

• YY indicates the year of manufacture.

i.e. 118WWSSSSSSS where 18

represents the year 2018.

• WW indicates the number of the

manufacturing week per a standard

shop calendar. (Leading zeros

included.)

• SSSSSSS is a sequential unique

number.

EN ISO 15223-1

Indicates the medical device Global

Trade Item Number

21 CFR 830

MDR 2017/745

Indicates the manufacturer’s lot code

using the Julian Date yyddd, where yy

indicates the last two digits of the year

and ddd indicates the day of the year. i.e.

April 4th, 2019 would be represented as

19094.

EN ISO 15223-1

INSTRUCTIONS FOR USE

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Indicates the date when the medical

device was manufactured

EN ISO 15223-1

Indicates the manufacturer’s catalogue

number

EN ISO 15223-1

Indicates the need for the user to consult

the instructions for use for important

cautionary information such as warnings

and precautions.

EN ISO 15223-1

Indicates the device do not contain

natural rubber or dry natural rubber latex

EN ISO 15223-1

Indicates the authorized representative in

the European Community

EN ISO 15223-1

Indicates the Medical Device complies to

REGULATION (EU) 2017/745

MDR 2017/745

Indicates a Warning

IEC 60601-1

Indicates the need for the user to consult

the instruction for use

EN ISO 15223-1

1.5.2 Intended User and Patient Population:

Intended User: Surgeons, Nurses, Doctors, Physicians and OR healthcare

professionals involved in the device intended procedure. Not intended for Lay

persons.

Intended Populations:

This device is intended to be used with patients that do not exceed the weight in the

safe working load field specified in the product specification section 4.2

INSTRUCTIONS FOR USE

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1.5.3 Compliance with medical device regulations:

This Product is a non-invasive, Class I Medical Device. This system is CE-

marked according to Annex VIII, Rule 1, of the Medical Device

Regulations (REGULATION (EU) 2017/745)

1.6 EMC considerations:

This is not an electromechanical device. Therefore, EMC Declarations are not

applicable

1.7 EC authorized representative:

HILL-ROM SAS

B.P. 14 - Z.I. DU TALHOUET

56330 PLUVIGNER

FRANCE

TEL: +33 (0)2 97 50 92 12

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

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.

INSTRUCTIONS FOR USE

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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.

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.

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

-29ᵒ C to +60ᵒ C

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.

Software Specifications

Description

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.

INSTRUCTIONS FOR USE

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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

INSTRUCTIONS FOR USE

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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) 
一般信息： ............................................................................................................................ 21 
1 版权声明： .................................................................................................................... 21 
2 商标： ........................................................................................................................... 21 
3 联系信息： .................................................................................................................... 22 
4 安全注意事项： ............................................................................................................. 22 
4.1 安全危险符号说明： ........................................................................................... 22 
4.2 设备误用声明： .................................................................................................. 22 
4.3 用户和/或患者注意事项： .................................................................................. 22 
4.4 安全处置： .......................................................................................................... 23 
5 操作系统： .................................................................................................................... 23 
5.1 适用符号： .......................................................................................................... 23 
5.2 目标用户和患者群体： ....................................................................................... 24 
5.3 符合医疗设备规定： ........................................................................................... 25 
6 EMC 注意事项： ........................................................................................................... 25 
7 EC 授权代表： .............................................................................................................. 25 
8 制造信息： .................................................................................................................... 25 
9 欧盟进口商信息： ......................................................................................................... 25 
10 授权的澳大利亚赞助商： .............................................................................................. 25 
系统 ....................................................................................................................................... 26 
1 系统组件标识： ............................................................................................................. 26 
2 产品代码和说明： ......................................................................................................... 26 
3 附件列表和耗材组件表： .............................................................................................. 26 
4 使用适应症： ................................................................................................................ 27 

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

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