Hillrom A-90001 Lift-Assist Beach Chair Instructions

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

80028153
Version C

A-90001 Lift-Assist Beach Chair

INSTRUCTIONS FOR USE

IMPORTANT NOTICES
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 onsite 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).

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

ext.4286
      978-263-8846|    +1 978 266 4426

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.

1.5 Operating the system:
1.5.1 Applicable Symbols:

| **** 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 yield, where by indicates the last two digits of the year and  did 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

1.5.2 Intended User and Patient Population:
Intended User: Surgeons, Nurses, Doctors, Physicians and OR healthcare professionals involved in the device intended procedure. Not intended for Lay persons.
Intended Populations:
This device is intended to be used with patients that do not exceed the weight in the safe working load field specified in the product specification section 4.2

1.5.3 Compliance with medical device regulations:
This Product is a non-invasive, Class I Medical Device. This system is Remarked 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

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.

A-30010UK (UK Rail), A-30010J (Japan Rail)
Name of Consumable| Product Number
Not applicable| Not applicable

Note: Consult the corresponding IFU for the products mentioned in the above table.

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.

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.
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).

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.

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:

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.

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.

CAUTION: DO NOT IMMERSE PADS IN ANY LIQUID
CAUTION: DO NOT USE BLEACH OR PHENOLICS ON PADS

List of Applicable Standards:

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
7.| ISTA| International Safe Transit Association standards for package testing

Hill-Rom Technical Support
hillrom.com/eon-us/about-us/locations/
Allen Medical Systems, Inc. is a subsidiary of Hill-Rom, Inc.

References

• allenmedical.com - allenmedical Resources and Information.
• allenmedical.com - allenmedical Resources and Information.
• Patents | Hillrom
• Patents | Hillrom
• Hillrom Locations by Country | Hillrom
• allenmedical.com - allenmedical Resources and Information.
• Patents | Hillrom
• Hillrom Locations by Country | Hillrom

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