Hillrom A-70801 Bow Frame Instruction Manual

A-70801 Bow Frame
Instruction Manual
80028150 Version B

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 the manufacturer’s suggestions. The final responsibility for patient care with respect to this device remains with the attending physician.

• The 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.

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 the listing at Hill-rom.com/patents for any patent(s).

Contact Details:

For ordering information please see the 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
1 YYWWSSSSSSS.
•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 date when the medical device was manufactured| EN ISO 15223-1
| 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 manufacturer’s catalog number| EN ISO 15223-1
---|---|---
| This indicates the need for the user to consult the instructions for using important cautionary information such as warnings and precautions.| EN ISO 15223-1
| Indicates the device does 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 with 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’s intended procedure. Not intended for Laypersons.
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 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 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:

Product Code and Description:

A-70801 – Allen Bow frame
List of Accessories and Consumable Components Table:
The following lists is accessories and components that may be used with this device.

Name of Accessory

|

Product number

---|---

Bow Frame Cart

|

A-70815

Crank Arm

| A-70821

Name of Consumable

|

Product number

Not Applicable.|

Not Applicable.

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

Indication for use:

The Bow Frame is used in a variety of surgical procedures including, but not limited to spine surgery. These devices are capable of being used with a broad patient population as determined appropriate by the caregiver or institution.

Intended use:

The Bow Frame is designed to position and support the patient’s chest and abdomen in a variety of surgical procedures including, but not limited to spine surgery. These devices are intended to be used by healthcare professionals within the Operating Room setting.

Residual Risk:

This product complies with relevant performance and safety standards. However, device or patient harm from misuse, device, functional, device damage or mechanical hazards 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 the product has been properly cleaned and disinfected and wiped dry prior to each use.
c. Verify table under BowTMFrame is rated for patient weight. (If this information is not available confirm rating with the table manufacturer prior to loading a patient).
d. Verify Hook/Loop Straps are in good condition.

**Setup:

**

a. Hold Bow ™The frame above rails and verify there is enough room to lower the Frame.

b. Lower head end of Bow Frame onto rails and slide to the desired location.

c. Ensure hook/loop straps are in between rails.

d. Lower Bow Frame completely onto rails.

SET-UP (COMPATIBLE RAIL SYSTEMS)
e. Bring hook/loop straps around rails and secure to Bow™ Frame. SET-UP (OR Table / Flat Surface)
a. Hold Bow Frame above the table and verify there is enough room to lower the frame. b. Place Frame on OR table with buttons facing head-end OR table.

c. Ensure enough room for Head Positioner. d. Ensure Frame is centered between OR table rails. e. Place hook/loop straps through OR Table Rails.

f. Bring straps around rails and secure back to Bow™ Frame.

LOADING THE PATIENT

Note: 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.

• Place moisture-absorbing / friction-reducing Bow Frame Disposable Covers over the supports.
• Prior to transferring the patient, crank Bow Frame to the highest setting. After transferring the patient, lower to the desired level.
• Position the patient to reduce nerve contact and subsequent injury.
• Additional support must be provided to the head, arms, and legs.

NEVER EXCEED THE WEIGHT CAPACITY OF THE O.R. TABLE.
Check all surfaces exposed to the patient to ensure there is no contact with any hard or sharp surfaces. Key areas to check are highlighted below.

Cover Cross Rod using Cross Rod Cover
Disposable or use another padding

Device controls and indicators:

To Adjust Pad Height

1. Insert Crank Handle into Bow Frame as shown.
2. Press Crank Handle in until fully engaged.
3. Support Crank Handle Rod with one hand and grab handle with the other.
4. To raise Bow Frame pads, turn the Crank Handle counter-clockwise.
5. To lower Bow Frame pads, turn the Crank Handle clockwise.

To adjust pad width

1. Ensure pads are at the lowest height.
2. To release the band, press inward at the free end of the band while pulling upward at the center of the band.
3. Pull band out from Pad Band Catch.
4. Locate Pad Width Adjustment Button at the opposite end of the frame.
5. Press the button firmly.
6. Shift rail laterally to the desired location and release the button.
7. Lower rail to front catch.
8. Press firmly inwards and tuck into Pad Band Catch.

Storage, Handling, and Removal Instructions:

Storage and Handling:
The product should be stored in a clean and safe environment to prevent product damage.

Removal Instruction:
To remove from table

1. Remove hook/loop strap from Bow ™ Frame and unwrap from rail
2. Remove from table and store on Bow Frame Cart.

Troubleshooting Guide:

This device does not have a troubleshooting guide. For technical support use 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 the 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 the 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. Test the locking mechanism to ensure no movement when elevated or pushed.
e. To reduce the chances of skin maceration and shear, it is required that a disposable cover be used between the patient and the pads.
f. To reduce the chances of patient tissue damage, care should be taken to ensure proper orientation and location of supports.
g. Do not tilt or flex the OR table while Bow Frame is on it.

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

Product Specifications:

High-Density Foam, Low-Density Foam, Garolite
Safe Working Load on the device| 500 lbs. Patient (226 kg)
Overall Weight of Complete Device| 29 lbs.(13.2 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 Bow frame is compatible with:|

• Allen Flex Frame or Allen Spine System
• Jackson Table or  Mizuho Modular Table
• Most competitor tables with 1 ¼” W x 1 ½” H x 17” spaced rails. 

Operating Room Table Compatibility| The Allen Bow frame is compatible with the following surgical table rail styles:  US, UK, EU, DEN, JP, SWISS.

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:

medical devices
2| ISO 14971| Medical devices- Application of risk management to medical devices.
3| 1041| Information supplied by the manufacturer of medical devices
4| ISO 15223-1| Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General requirements
5| ISO 10993-1| Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
6| ISO 10993-5| Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
7| ISO 10993-10| Biological evaluation of medical devices – part 10: tests for irritation and skin sensitization
8| IEC 60601-2-46| Medical electrical equipment – Part 2-46: Requirements for the basic safety and essential performance of operating tables
9| ISTA| International Safe Transit Association standards for package testing

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

Document Number: 80028150
Version: B
Issue Date: 26 MAR 2020
Ref Blank Template: 80025117 Ver. F

References

• Advancing Connected Care | Hillrom
• allenmedical.com - allenmedical Resources and Information.
• allenmedical.com - allenmedical Resources and Information.
• Advancing Connected Care | Hillrom
• 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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