Hillrom A-70801 Manual de utilizare

Bow Frame

Instructions for Use

Product No. A-70801

80028150

Version B

Allen® Bow Frame (A-70801)

 
INSTRUCTIONS FOR USE 
Document Number: 80028150 Page 2  Issue Date: 26 MAR 2020 
 
Version: B    Ref Blank Template: 80025117 Ver. F 
 
ENGLISH .......................................................................................................................................... 3 
 
中文简体 ........................................................................................................................................ 26 
 
HRVATSKI ...................................................................................................................................... 49 
 
ČESKÝ ........................................................................................................................................... 72 
 
DANSK .......................................................................................................................................... 95 
 
NEDERLANDS ............................................................................................................................. 118 
 
SUOMI ......................................................................................................................................... 142 
 
FRANÇAIS ................................................................................................................................... 165 
 
DEUTSCH ..................................................................................................................................... 188 
 
ΕΛΛΗΝΙΚΑ .................................................................................................................................. 211 
 
ITALIANO .................................................................................................................................... 236 
 
LATVISKI ...................................................................................................................................... 259 
 
POLSKI ......................................................................................................................................... 282 
 
PORTUGUÊS ................................................................................................................................ 305 
 
ROMÂNESC................................................................................................................................ 329 
 
SRPSKI ......................................................................................................................................... 352 
 
SLOVENSKY ................................................................................................................................ 376 
 
SLOVENŠČINA ........................................................................................................................... 399 
 
ESPAÑOL .................................................................................................................................... 422 
 
SVENSKA ..................................................................................................................................... 446

INSTRUCTIONS FOR USE

Document Number: 80028150 Page 3 Issue Date: 26 MAR 2020

Version: B 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 
Document Number: 80028150 Page 4  Issue Date: 26 MAR 2020 
 
Version: B    Ref Blank Template: 80025117 Ver. F 
Table of Contents 
Allen® Bow Frame (A-70801) 
General Information: ........................................................................................................... 6 
1 Copyright Notice: ........................................................................................................ 6 
2 Trademarks: ................................................................................................................... 6 
3 Contact Details: ........................................................................................................... 7 
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: ..................................................................................................... 8 
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: .......................................... 10 
6 EMC considerations: .................................................................................................. 10 
7 EC authorized representative: ................................................................................. 10 
8 Manufacturing Information: ..................................................................................... 10 
9 EU Importer Information: ........................................................................................... 10 
10 Australian sponsor Information: ................................................................................ 10 
System ................................................................................................................................. 11 
1 System components Identification: ......................................................................... 11 
2 Product Code and Description:............................................................................... 11 
3 List of Accessories and Consumable Components Table:................................... 12 
4 Indication for use: ...................................................................................................... 12 
5 Intended use: .............................................................................................................. 12 
6 Residual Risk: ............................................................................................................... 12 
Equipment Setup and Use: ............................................................................................... 13 
1 Prior to use: .................................................................................................................. 13 
2 Setup: ........................................................................................................................... 13 
3 Device controls and indicators: ............................................................................... 17 
4 Storage, Handling and Removal Instructions: ........................................................ 20 

 
INSTRUCTIONS FOR USE 
Document Number: 80028150 Page 5  Issue Date: 26 MAR 2020 
 
Version: B    Ref Blank Template: 80025117 Ver. F 
4.1 Storage and Handling: ................................................................................... 20 
4.2 Removal Instruction: ........................................................................................ 20 
5 Troubleshooting Guide: ............................................................................................. 21 
6 Device Maintenance: ............................................................................................... 21 
Safety Precautions and General Information:............................................................... 21 
1 General Safety Warnings and Cautions: ................................................................ 21 
2 Product Specifications: ............................................................................................. 22 
3 Sterilization Instruction: .............................................................................................. 23 
4 Cleaning and Disinfection Instruction: .................................................................... 23 
List of Applicable Standards: ........................................................................................... 23 
 
   

INSTRUCTIONS FOR USE

Document Number: 80028150 Page 6 Issue Date: 26 MAR 2020

Version: B 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).

INSTRUCTIONS FOR USE

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International

North America

1.3 Contact Details:

For ordering information please see catalog.

Allen Customer Service Contact Information:

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 product if the 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

(800) 433-5774

+1 978 266 4200 ext.4286

(978) 263-8846

+1 978 266 4426

INSTRUCTIONS FOR USE

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Version: B Ref Blank Template: 80025117 Ver. F

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:

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 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

EN ISO 15223-1

INSTRUCTIONS FOR USE

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indicates the day of the year. i.e. April 4th,

2019 would be represented as 19094.

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

INSTRUCTIONS FOR USE

Document Number: 80028150 Page 10 Issue Date: 26 MAR 2020

Version: B Ref Blank Template: 80025117 Ver. F

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.

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:

TRUMPF Medizin Systeme GmbH + Co. KG

Carl-Zeiss Straße 7-9

07318 Saalfeld/Saale

Germany

1.10 Australian sponsor Information:

Welch Allyn Australia Pty. Ltd.

Unit 4.01 2-4 Lyonpark Road

Macquarie Park, NSW 2113

Phone 1800 650 083

INSTRUCTIONS FOR USE

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Version: B Ref Blank Template: 80025117 Ver. F

2 System

2.1 System components Identification:

2.2 Product Code and Description:

A-70801 - Allen Bow frame

Pads

Pad Band

Catch

Rail Rod

Connectors

Hook/Loop Straps

Crank Handle

Pad Width Adjustment Buttons

INSTRUCTIONS FOR USE

Document Number: 80028150 Page 12 Issue Date: 26 MAR 2020

Version: B Ref Blank Template: 80025117 Ver. F

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

Bow Frame Cart

A-70815

Crank Arm

A-70821

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

2.4 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.

2.5 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.

2.6 Residual Risk:

This product complies with relevant performance, safety standards. However,

device or patient harm from misuse, device, functional, device damage or

mechanical hazards cannot be completely excluded.

Name of Consumable

Product number

Not Applicable.

INSTRUCTIONS FOR USE

Document Number: 80028150 Page 13 Issue Date: 26 MAR 2020

Version: B Ref Blank Template: 80025117 Ver. F

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. Verify table under BowTMFrame is rated for patient weight. (If this information is

not available confirm rating with table manufacturer prior to loading a patient).

d. Verify Hook/Loop Straps are in good condition.

3.2 Setup:

a. Hold BowTM 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 desired location.

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

INSTRUCTIONS FOR USE

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Version: B Ref Blank Template: 80025117 Ver. F

d. Lower Bow Frame completely onto rails.

SET-UP (COMPATIBLE RAIL SYSTEMS)

e. Bring hook/loop straps around rails and

secure to BowTM Frame.

SET-UP (OR Table / Flat Surface)

a. Hold Bow Frame above table and

verify there is enough room to lower

the frame.

b. Place Frame on OR table with

buttons facing head end OR table.

INSTRUCTIONS FOR USE

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c. Ensure enough room for Head

Positioner.

d. Ensure Frame is centered

between OR table rails.

SET-UP (OR Table)

e. Place hook/loop straps through OR Table

Rails.

f. Bring straps around rails and secure

back to BowTM Frame.

INSTRUCTIONS FOR USE

Document Number: 80028150 Page 16 Issue Date: 26 MAR 2020

Version: B Ref Blank Template: 80025117 Ver. F

LOADING THE PATIENT

Note: 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.

• Place moisture absorbing / friction reducing

Bow Frame Disposable Covers over the

supports.

• Prior to transferring the patient, crank Bow

Frame to highest setting. After transferring the

patient, lower to 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 CAPACITYOF THE O.R. TABLE.

Check all surfaces exposed to 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 other padding

Cover Pad Band Catch

INSTRUCTIONS FOR USE

Document Number: 80028150 Page 17 Issue Date: 26 MAR 2020

Version: B Ref Blank Template: 80025117 Ver. F

3.3 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 other.

INSTRUCTIONS FOR USE

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Version: B Ref Blank Template: 80025117 Ver. F

To Adjust Pad height

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 lowest height.

2. To release band, press inward at free

end of band while pulling upward at

center of band.

INSTRUCTIONS FOR USE

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3. Pull band out from Pad Band Catch.

To adjust pad width

4. Locate Pad Width Adjustment Button

at opposite end of frame.

5. Press button firmly.

6. Shift rail laterally to desired location

and release button.

INSTRUCTIONS FOR USE

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Version: B Ref Blank Template: 80025117 Ver. F

To adjust pad width

7. Lower rail to front catch.

8. Press firmly inwards and tuck into Pad

Band Catch.

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.

3.4.2 Removal Instruction:

To remove from table

1. Remove hook/loop strap from

BowTM Frame and unwrap from

rail

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