Hillrom A-71404 Advance Cervical Traction Bar Instruction Manual

: June 9, 2024
: Hillrom

Table of Contents

Hillrom A-71404 Advance Cervical Traction Bar
INSTRUCTIONS FOR USE
General Information
Safety Considerations
Operating the system
System
Indication for use
Equipment Setup and Use
- Storage, Handling and Removal Instructions
Safety Precautions and General Information
- General Safety Warnings and Cautions
Product Specifications
Cleaning and Disinfection Instruction
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Hillrom A-71404 Advance Cervical Traction Bar

INSTRUCTIONS FOR USE

IMPORTANT NOTICES

WARNING: 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.

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.

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.

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 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).

Contact Details

For ordering information please see catalog. Allen Customer Service Contact Information

Safety Considerations

Safety hazard symbol notice

WARNING: DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE OR MATERIAL DEGRADATION.

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.

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.

WARNING: NEVER EXCEED THE WEIGHT CAPACITY OF THE OPERATING ROOM TABLE

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.

Operating the system

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. 1 18 WWSSSSSSS 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

****| 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

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

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: +33 (0)2 97 50 92 12

Manufacturing Information

ALLEN MEDICAL SYSTEMS, INC. 100 DISCOVERY WAY
ACTON, MA 01720 US
800-433-5774 (NORTH AMERICA) 978-266-4200 (INTERNATIONAL)

EU Importer Information

Baxter Medical Systems GmbH + Co. KG Carl-Zeiss Straße 7-9
07318 Saalfeld/Saale
Germany

Authorized Australian sponsor

Welch Allyn Australia Pty. Ltd. 1 Baxter Drive
Old Toongabbie, NSW 2146 Australia

System

System components Identification

Hillrom-A-71404-Advance-Cervical-Traction-Bar-FIG-17

Product Code and Description

A-71404 – Advance Cervical Traction Bar

List of Accessories and Consumable Components Table

The following list are accessories and components that may be used with this device.

Name of Accessory	Product Number
Not Applicable	Not Applicable
Name of Consumable	Product Number
---	---
Not Applicable	Not Applicable

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.

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.

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.
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.

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).

Determine the hole location for the cervical traction bar.
Put the bar into the H-bracket openings.
Make sure the drop locks on each end of the bar moves to the side to hold the bar in position.
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.

Device controls and indicators

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

Storage, Handling and Removal Instructions

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.

Removal Instruction
Pull the bar from the H-bracket openings

Troubleshooting Guide
This device does not have a troubleshooting guide. For technical support user of the device shall first contact Hill-Rom Technical Support.

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).

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. 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

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
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 Advance Cervical Traction Bar is

compatible with:

| Allen® Advance Table (A-71100) through the

Advance H-Brackets (A-71402)

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.

List of Applicable Standards