Hillrom A-71404 Používateľská príručka

Advance Cervical Traction Bar

Instructions for Use

Product No. A-71404

80028188

Version C

INSTRUCTIONS FOR USE 
Document Number: 80028188 Page 2  Issue Date: 16 MAR 2020 
 
Version C    Ref Blank Template: 80025117 Ver. F 
 
ENGLISH  ........................................................................................................................................  3 
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INSTRUCTIONS FOR USE

Document Number: 80028188 Page 3 Issue Date: 16 MAR 2020

Version C Ref Blank Template: 80025117 Ver. F

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 
Advance Cervical Traction Bar (A-71404) 
General Information: ....................................................................................................... 6 
1 Copyright Notice: ......................................................................................................... 6 
2 Trademarks: ................................................................................................................... 6 
3 Contact Details: ............................................................................................................ 6 
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: ...................................................................................................... 7 
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: ............................................. 9 
6 EMC considerations: .................................................................................................... 9 
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: ....................................................................................................... 11 
5 Intended use: .............................................................................................................. 12 
Equipment Setup and Use: ............................................................................................ 12 
1 Prior to use: .................................................................................................................. 12 
2 Setup: ........................................................................................................................... 13 
3 Device controls and indicators: ............................................................................... 13 
4 Storage, Handling and Removal Instructions: ........................................................ 13 

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

INSTRUCTIONS FOR USE

Document Number: 80028188 Page 6 Issue Date: 16 MAR 2020

Version C Ref Blank Template: 80025117 Ver. F

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).

1.3 Contact Details:

For ordering information please see catalog.

Allen Customer Service Contact Information:

INSTRUCTIONS FOR USE

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International

North America

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

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.

(800) 433-5774

+1 978 266 4200 ext.4286

(978) 263-8846

+1 978 266 4426

INSTRUCTIONS FOR USE

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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

Indicates the date when the medical

device was manufactured

EN ISO 15223-1

Indicates the manufacturer’s

catalogue number

EN ISO 15223-1

INSTRUCTIONS FOR USE

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Indicates the need for the user to

consult the instructions for use for

important cautionary information such

as warnings and precautions.

EN ISO 15223-1

Indicates the device do not contain

natural rubber or dry natural rubber

latex

EN ISO 15223-1

Indicates the authorized representative

in the European Community

EN ISO 15223-1

Indicates the Medical Device complies

to REGULATION (EU) 2017/745

MDR 2017/745

Indicates a Warning

IEC 60601-1

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 adults and pediatric patients

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.

INSTRUCTIONS FOR USE

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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 US

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

INSTRUCTIONS FOR USE

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2 System

2.1 System components Identification:

2.2 Product Code and Description:

A-71404 - Advance Cervical Traction Bar

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

Not Applicable

2.4 Indication for use:

The Advance Cervical Traction Bar is used in a variety of surgical procedures

including, but not limited to cervical surgery. These devices are capable of being

used with a broad patient population as determined appropriate by the

caregiver or institution.

Name of Consumable

Product Number

Not Applicable

Cervical Traction Bar

INSTRUCTIONS FOR USE

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2.5 Intended use:

The Advance Cervical Traction Bar is designed to be used as a distractor in a

variety of surgical procedures including, but not limited to cervical surgery. 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.

c. Tools required: None

d. Parts required: A-71404 (Advance Cervical Traction Bar)

e. Pre-Use Checks table

Condition

Associated Indicator(s)

The Table power cord is connected to the

Table and to an applicable power outlet.

The Power indicator is on.

The On/Off switch is on.

The Battery Charge Level indicator is on.

The brakes are locked.

Locked indicator is green; Unlocked indicator is

off.

The Table is in Pendant mode.

The Pendant Control indicator is green; the Manual

Flip indicator is off.

The columns are level (at the same height).

Near the bottom on the outside of the columns

there are numbers to help identify height level.

The support top is horizontal (not tilted).

Tilt Level indicator is green; the Tilt indicator is in

the center of the Tilt Indicator Area.

INSTRUCTIONS FOR USE

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3.2 Setup:

The cervical traction bar gets installed on the support top-side of the head-end H-

bracket (see figure System components Identification section 2.1).

1. Determine the hole location for the cervical traction bar.

2. Put the bar into the H-bracket openings.

3. Make sure the drop locks on each end of the bar moves to the side to hold the bar

in position.

4. For use information, refer to the Allen®1 Advance Table User Manual (D-720686)

and to the warnings on 4.1 General Safety Warnings and Cautions section 4.

3.3 Device controls and indicators:

Refer to the Allen®1 Advance Table User Manual (D-720686)

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.

3.4.2 Removal Instruction:

Pull the bar from the H-bracket openings

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 us if you need to repair or replace the device by using the information

from the contact details section (1.3).

INSTRUCTIONS FOR USE

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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. The maximum diameter of the traction rope should be 0.25" (6.35 mm). The use of

a traction rope that is greater than 0.25" (6.35 mm) in diameter could cause

binding inside the cervical traction assembly. Patient injury could occur as a result

of inaccurate traction.

e. The maximum weight load for the traction assembly is 50 lb (22.6 kg). To exceed

this weight could cause patient fall, injury, or equipment damage.

f. Make sure the traction weight is in a safe position, free from possible unintended

movement. Failure to do so could cause patient fall, injury, or equipment damage.

g. Do not press the Cervical Traction Release button while traction weight is being

applied. To do so could cause the assembly to retract and the traction weight to

move. Patient fall, injury, or equipment damage could occur.

CAUTION:

Do not exceed safe working load shown in the product specification table

4.2 Product Specifications:

Mechanical Specifications

Description

Product Dimensions

The Cervical Traction Bar is 11.75” long

(29.8 cm)

Material

Stainless Steel

Safe Working Load on the device

The maximum weight load for the traction

assembly is 50 lbs (22.6 kg)

Overall Weight of Complete Device

Approx. 1lbs (0.45 kg)

Storage Specifications

Description

Storage temperature

-29° C to +60° C

INSTRUCTIONS FOR USE

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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.

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.

5 List of Applicable Standards:

Sl. no

Standards

Description

1.

EN 62366-1

Medical devices - Part 1: Application of usability

engineering to medical devices

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 Advance Cervical Traction Bar is

compatible with:

Allen® Advance Table (A-71100) through the

Advance H-Brackets (A-71402)

INSTRUCTIONS FOR USE

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Sl. no

Standards

Description

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

Advance Cervical Traction Bar

使用说明

产品编号 A-71404

80028188

Version C

使用说明

Document Number: 80028188 第 18 页 Issue Date: 16 MAR 2020

Version C Ref Blank Template: 80025117 Ver. F

重要声明

• 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。

• 本设备仅能由经过培训的人员操作。

• 任何修改、升级或维修都必须由经过授权的专业人员执行。

• 请保管本手册供日后参考。

• 发生与本设备有关的任何严重事故，应报告制造商和此文档所列主管当局。

将本设备或其他类型的医疗仪器用于患者之前，建议您先阅读本

《使用说明》

并熟悉该产品。

使用说明 
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目录 
Advance Cervical Traction Bar (A-71404) 
一般信息： ...................................................................................................................... 21 
1 版权声明： .................................................................................................................... 21 
2 商标： ........................................................................................................................... 21 
3 联系信息： .................................................................................................................... 21 
4 安全注意事项： ............................................................................................................. 22 
4.1 安全危险标志说明： ........................................................................................... 22 
4.2 产品误用说明： .................................................................................................. 22 
4.3 用户和/或患者通知： ......................................................................................... 22 
4.4 安全弃置： .......................................................................................................... 22 
5 操作系统： .................................................................................................................... 23 
5.1 适用符号： .......................................................................................................... 23 
5.2 适用用户和患者人群： ....................................................................................... 24 
5.3 医疗设备法规符合性： ....................................................................................... 24 
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 产品代码和描述： ......................................................................................................... 26 
3 附件列表和耗材组件表： .............................................................................................. 26 
4 适用范围： .................................................................................................................... 26 

使用说明 
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5 预期用途： .................................................................................................................... 27 
设备设置与使用： ............................................................................................................ 27 
1 使用之前： .................................................................................................................... 27 
2 设置： ........................................................................................................................... 28 
3 设备控制键和指示灯： .................................................................................................. 28 
4 存储、操作处置和拆卸说明： ....................................................................................... 28 
4.1 存储和操作处置： ............................................................................................... 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: ................................................................................................ 29 
1 一般安全警告和小心： .................................................................................................. 29 
2 产品规格： .................................................................................................................... 29 
3 灭菌说明： .................................................................................................................... 30 
4 清洁与消毒说明： ......................................................................................................... 30 
适用标准列表： ............................................................................................................... 31 
 
  

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