Hillrom A-93005 Allen Traction Boot Instructions

Hillrom A-93005 Allen Traction Boot

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 the 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 healthcare 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.

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/termsconditions.
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

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

Equipment misuse notice

Do not use the product if the 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.

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:

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 patients that do not exceed the weight in the safe working load field specified in the product specification section 4.2.

Compliance with medical device regulations
 This Product is a non-invasive, Class I Medical Device. This system is CEmarked 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 USA
800-433-5774 (NORTH AMERICA)
978-266-4200 (INTERNATIONAL)

EU Importer Information:
TRUMPF Medizin Systeme GmbH + Co. KG
Carl-Zeiss Straße 7-9
07318 Saalfeld/Saale
Germany

Australian sponsor Information:
Welch Allyn Australia Pty. Ltd.
Unit 4.01, 2-4 Lyonpark Road
Macquarie Park, NSW 2113
Phone 1800 650 083

System

System components Identification

Allen® Traction Boot – Modular:

Modular Attachment for Steris® Systems:

ATB – Modular Attachment for Mizuho OSI ® Systems

Product Code and Description:

• A-93005 – Allen Traction Boot – Modular
• A-93006 – ATB- Modular Attach for Steris Systems
• A-93007 – ATB- Modular Attach for Mizuho OSI Syss

List of Accessories and Consumable Components Table:

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

Note: Consult the corresponding IFU for the products mentioned in the above table.
CAUTION: Reuse of disposables will lead to patient cross-contamination and/or device failure.

Indication for use:
The Traction Boot is used for hip surgery. These devices are capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
Intended use:
The Traction Boot is designed to position, support and/or distract the patient’s foot for hip surgery. These devices are intended to be used by healthcare professionals within the Operating Room setting.
Residual Risk:
This product complies with relevant performance, safety standards. However, user harm from functional, device damage or mechanical hazard cannot be completely excluded.

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.

Boot Assembly:

a. Loosen boot rotation knob and remove from boot.
b. Place Modular Attachment onto boot (Note: Ensure rubber disk is on).
c. Tighten boot rotation knob onto boot and tighten until secure. Installing the Boot onto Mizuho OSI ® Systems:

a. Remove OSI ® Traction Boot (and footplate, if present) from traction unit.
b. Fully insert Allen® Traction Boot for Mizuho OSI ® Systems into traction unit.
c. Tighten top knob securely.

Installing the Boot onto Steris ® Systems:

a. Remove Steris® Traction Boot (and footplate, if present) from traction unit.
b. Fully insert Steris® Plate into traction unit.
c. Tighten knob securely.

Boot Preparation:

a. Loosen ratchet buckle by pulling down on the tab and moving the buckle to the bottom of the boot.
b. Loosen middle strap by pulling outward.
c. Undo buckles and lay straps outside of boot.

Setup

Disposable Usage:

a. Place disposable with ink side down and place ankle on circle cutout.
b. Wrap ankle section around patient ankle and secure with Velcro® strap.
c. Wrap calf section around patient calf and secure with 2X Velcro® straps.
d. Wrap foot section around patient foot and secure with Velcro® strap.

NOTE: If necessary, excess foam can be removed by tearing perforations.

Foot Placement:
a. Place foot in boot so dotted outline on disposable sits directly on blue pad.
b. Buckle middle buckle around ankle so the strap is directly over the top of the ankle.
c. Pull on lever of ratchet buckle and tighten ankle strap until secure.
d. Buckle toe and calf buckles and tighten by pulling on the two straps.

Note: Check all connections of boot to ensure they are secure which is shown in red circles.

Steris®

OSI ®

Device controls and indicators

Boot Rotation – Mizuho OSI ® System:

1. Unscrew handle of rotation lock
2. Rotate boot to desired angle
3. Tighten handle of rotation lock until boot is secure

ALWAYS SUPPORT PATIENT LIMBS BEFORE MAKING ANY DEVICE ADJUSTMENT

Boot Dorsiflexion and Plantarflexion – Mizuho OSI® Systems:

1. Unlock flexion/extension lock by pulling cam handle outwards
2. Flex/extend boot to desired angle
3. Lock flexion/extension lock by pulling cam handle inwards
4. Check to ensure teeth are interlocking properly

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:

1. Unbuckle straps around the toe, ankle, and calf
2. Device may be stored with table
3. Lift foot out of boot
4. Turn knob & remove boot

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 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

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. All modifications, upgrades, or repairs must be performed by an authorized specialist.
e. To reduce the chances of patient tissue damage, care should be taken to ensure proper orientation and location of padding.

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

Product Specifications

Product Dimensions

| A-93007: 14”x8”x17” (35.5cm x 20.3cm x 43cm)

A-93006: 13”x8”x21” (33cm x 20.3cm x 53.3cm)

Material

| Polycarbonate ABS , Ethylene foam, Polyethylene foam, UBL fabric, Nylon webbing, Aluminum, Stainless steel, Acetal, Plastic,

Velcro®

Safe Working Load on the device| 500 lbs. Patient (226 kg)
Overall Weight of Complete Device| A-93006 : 5.5 lbs. (2,5 kg)

A-93007 : 5.4 lbs. (2,4 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.| Not Applicable.
Software Specifications| Description
Not Applicable.| Not Applicable.
Compatibility Specifications| Description
The Allen® Traction Boot – Modular is compatible with:

| ****

Modular Attachment for Steris® Systems (A-93006) & the Modular Attachment for Mizuho OSI ® Systems (A-93007).

The Modular Attachment for Steris® Systems is compatible with:

| ****

Steris Orthovision ® Fracture Table & Steris Orthovision ® Extension.

The Modular Attachment for Mizuho OSI ® Systems is compatible with

| ****

OSI Orthopedic Trauma Tabletop (Jackson® Fracture Top) and the OSI Ovation® Orthopedic Trauma Table.

---|---

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.

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

References

• Patents | Hillrom
• Hillrom Locations by Country | Hillrom
• Patents | Hillrom
• Hillrom Locations by Country | Hillrom

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