Hillrom A-70270 Instrucțiuni de utilizare

ContourTM Breast Positioners

Instructions for Use

Product No. A-70270

80028170

Version B

Allen® Contour Breast Positioners (A-70270)

 
INSTRUCTIONS FOR USE         
Document Number: 80028170 Page 2  Issue Date: 26 MAR 2020 
   
Version: B    Ref Blank Template: 80025117Ver. F  
 
ENGLISH .......................................................................................................................................... 3 
 
SUOMI ........................................................................................................................................... 19 
 
FRANÇAIS ..................................................................................................................................... 35 
 
DEUTSCH ....................................................................................................................................... 52 
 
ITALIANO ...................................................................................................................................... 70 
 
NORSK .......................................................................................................................................... 86 
 
ROMÂNESC................................................................................................................................ 103 
 
SRPSKI ......................................................................................................................................... 121 
 
SLOVENSKY ................................................................................................................................ 155 
 
SLOVENŠČINA ........................................................................................................................... 138 
 
ESPAÑOL .................................................................................................................................... 173 
 
SVENSKA ..................................................................................................................................... 192

INSTRUCTIONS FOR USE

Document Number: 80028170 Page 3 Issue Date: 26 MAR 2020

Version: B Ref Blank Template: 80025117Ver. 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         
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Version: B    Ref Blank Template: 80025117Ver. F  
Table of Contents 
Allen® ContourTM Breast Positioners (A-70270) 
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 
Equipment Setup and Use: ............................................................................................... 13 
1 Prior to use: .................................................................................................................. 13 
2 Setup: ........................................................................................................................... 13 
3 Device controls and indicators: ............................................................................... 14 
4 Storage, Handling and Removal Instructions: ........................................................ 14 
1.1 Storage and Handling: ................................................................................... 14 

 
INSTRUCTIONS FOR USE         
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Version: B    Ref Blank Template: 80025117Ver. F  
1.2 Removal Instruction: ........................................................................................ 14 
5 Troubleshooting Guide: ............................................................................................. 15 
6 Device Maintenance: ............................................................................................... 15 
Safety Precautions and General Information:............................................................... 15 
1 General Safety Warnings and Cautions: ................................................................ 15 
2 Product Specifications: ............................................................................................. 16 
3 Sterilization Instruction: .............................................................................................. 16 
4 Cleaning and Disinfection Instruction: .................................................................... 16 
List of Applicable Standards: ........................................................................................... 17 
 
   

INSTRUCTIONS FOR USE

Document Number: 80028170 Page 6 Issue Date: 26 MAR 2020

Version: B Ref Blank Template: 80025117Ver. 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.

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.

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

Contact Details:

For ordering information please see catalog.

Allen Customer Service Contact Information:

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:

All modifications, upgrades, or repairs must be performed by an authorized

specialist.

Do not use the product if package is damaged or unintentionally opened before

use.

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: 80025117Ver. 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.

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 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

INSTRUCTIONS FOR USE

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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

INSTRUCTIONS FOR USE

Document Number: 80028170 Page 10 Issue Date: 26 MAR 2020

Version: B Ref Blank Template: 80025117Ver. 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)

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

INSTRUCTIONS FOR USE

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Version: B Ref Blank Template: 80025117Ver. F

2 System

System components Identification:

Product Code and Description:

A-70270 - Allen® Contour Breast Positioners

Adjustment

Levers

Mounting

Latches

Center Chest Pad

Left Chest Pad

Right Chest Pad

INSTRUCTIONS FOR USE

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Version: B Ref Blank Template: 80025117Ver. F

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

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 Wing Set is used in a variety of surgical procedures including, but not limited to

spine surgery that requires prone positioning. These devices are capable of being

used with a broad patient population as determined appropriate by the caregiver

or institution.

Intended use:

The Wing Set is designed to position and support the patient’s chest and/or hip in a

variety of surgical procedures including, but not limited to spine surgery that

requires prone positioning. These devices are intended to be used by healthcare

professionals within the Operating Room setting.

Name of Consumable

Product number

Contour Cover Disposables

A-70271

INSTRUCTIONS FOR USE

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3 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.

Setup:

a. Attach device to frame with indicated side forward (towards head of patient).

Secure device by firmly pressing on latch as shown.

b. Adjust Pads by unlocking adjustment

levers and moving pads as required.

Upper lever locks and unlocks

rotational adjustment. Lower lever

locks and unlocks width adjustment.

Pads should generally be used as

shown with all pads centered and

touching unless patient anatomy

requires different configuration.

Patient Positioning:

1

2

Pads Touching

INSTRUCTIONS FOR USE

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Version: B Ref Blank Template: 80025117Ver. F

a. Attach disposable cover (A-70271) after pads have

been positioned and locked. Flaps should face

forward, and foam material should be face up.

Secure adhesive tabs as indicated. Avoid attaching

tabs directly to pads.

b. Transfer patient onto device so that breasts fall over

edge of device as shown. Breasts should fall naturally,

without being subjected to excessive forces.

c. While supporting breast, wrap outer flap first, then

wrap inner flap and secure using adhesive tab.

Smaller breasts may not require flap support.

Device controls and indicators:

Controls and indicators of this device are described within the Setup instructions.

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 device, pull latch firmly while pressing down

on white clamp.

INSTRUCTIONS FOR USE

Document Number: 80028170 Page 15 Issue Date: 26 MAR 2020

Version: B Ref Blank Template: 80025117Ver. F

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).

4 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. 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. Do not apply weight when the Contour is mounted upside down.

f. Apply the Contour Disposable Cover to the device before each procedure.

CAUTION:

a. Do not pour or spray any liquid directly onto the device.

b. Do not submerge the device.

c. Avoid exposing the device to excessive moisture.

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

INSTRUCTIONS FOR USE

Document Number: 80028170 Page 16 Issue Date: 26 MAR 2020

Version: B Ref Blank Template: 80025117Ver. F

Product Specifications:

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.

Mechanical Specifications

Description

Product Dimensions

33.3” X 22.38” (84.5 cm x 56.8 cm)

Material

HSSX-7 Polyurethane Foam, Tyvek

Safe Working Load on the device

500 lbs. Patient (226 kg)

Overall Weight of Complete Device

10 lbs. (4.5 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.

Software Specifications

Description

Not Applicable.

Compatibility Specifications

Description

The Allen® Contour Breast Positioners is

compatible with:

 Allen Flex Frame

 Jackson Table

 Other spinal frame with 17” (43 cm)

spaced 1 ¼” (3,2 cm) W x 1 ½” (3,8 cm)

H

INSTRUCTIONS FOR USE

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Version: B Ref Blank Template: 80025117Ver. F

 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

5 List of Applicable Standards:

Sl. no

Standards

Description

1.

EN 62366-1

Medical devices - Part 1: Application of usability engineering 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

ContourTM Breast Positioners

Käyttöohje

Tuotenumero A-70270

80028170

Version B

KÄYTTÖOHJE

Document Number: 80028170 Sivu 19 Issue Date: 26 MAR 2020

Version: B Ref Blank Template: 80025117Ver. F

TÄRKEITÄ HUOMAUTUKSIA

• Perehdy kaikkiin tässä käyttöoppaassa ja itse laitteessa oleviin varoituksiin

ennen laitteen käyttämistä potilaalla.

• Symboli on tarkoitettu kiinnittämään käyttäjän huomio laitteen

käyttöön liittyviin tärkeisiin toimenpide- ja turvallisuusohjeisiin.

Merkinnöissä oleva symboli osoittaa, milloin on katsottava lisätietoja

käyttöohjeesta.

• Tässä käyttöoppaassa kuvatut tekniikat ovat vain valmistajan suosituksia.

Lopullinen vastuu potilaan hoidosta tällä laitteella säilyy hoitavalla

lääkärillä.

• Laitteen toiminta on tarkistettava ennen jokaista käyttökertaa.

• Tätä laitetta saa käyttää vain koulutettu henkilökunta.

• Kaikki muutokset, päivitykset ja korjaukset on annettava valtuutetun

asiantuntijan tehtäväksi.

• Säilytä tämä käyttöopas tulevaa käyttöä varten.

Kaikki laitteeseen liittyvät vakavat vaaratilanteet on ilmoitettava

valmistajalle ja tässä asiakirjassa mainitulle asianmukaiselle viranomaiselle.

Ennen tämän tai minkään muun lääketieteellisen laitteen

potilaskäyttöä on suositeltavaa, että käyttäjä lukee käyttöohjeen ja

perehtyy laitteen toimintaan.

 
KÄYTTÖOHJE 
Document Number: 80028170 Sivu 20  Issue Date: 26 MAR 2020 
   
Version: B    Ref Blank Template: 80025117Ver. F  
Sisällysluettelo 
Allen® ContourTM Breast Positioners (A-70270) 
Yleistä tietoa: ...................................................................................................................... 22 
1 Tekijänoikeusilmoitus: ................................................................................................. 22 
2 Tavaramerkit: .............................................................................................................. 22 
3 Yhteystiedot: ............................................................................................................... 23 
4 Turvallisuutta koskevat huomiot: .............................................................................. 23 
1.1 Turvallisuusriskin osoittavaa symbolia koskeva huomautus: ...................... 23 
1.2 Laitteen vääränlaista käyttöä koskeva huomautus: .................................. 23 
1.3 Huomautus käyttäjille ja/tai potilaille: ........................................................... 23 
1.4 Turvallinen hävittäminen: ............................................................................... 24 
5 Järjestelmän käyttö: .................................................................................................. 24 
1.5 Sovellettavat symbolit: .................................................................................... 24 
1.6 Kohdekäyttäjät ja potilaspopulaatio: .......................................................... 25 
1.7 Lääkinnällisiä laitteita koskevien asetusten noudattaminen: .................... 26 
6 Sähkömagneettista yhteensopivuutta koskevat huomiot: .................................. 26 
7 Valtuutettu edustaja Euroopan yhteisössä: ........................................................... 26 
8 Valmistustiedot: .......................................................................................................... 26 
9 Maahantuoja EU-alueella: ........................................................................................ 26 
10 Edustaja Australiassa: ................................................................................................ 26 
Järjestelmä ......................................................................................................................... 27 
11 Järjestelmän osien tunnistaminen: .......................................................................... 27 
12 Tuotekoodi ja tuotteen kuvaus: ............................................................................... 27 
13 Luettelo lisävarusteista ja kulutusosista:................................................................... 28 
14 Käyttöaihe: .................................................................................................................. 28 
15 Käyttötarkoitus: ........................................................................................................... 28 
Laitteen asennus ja käyttö: .............................................................................................. 29 
16 Ennen käyttöä: ........................................................................................................... 29 
17 Asennus: ...................................................................................................................... 29 
18 Laitteen säätimet ja merkinnät: ............................................................................... 30 
19 Säilytys-, käsittely- ja irrotusohjeet: ........................................................................... 30 
1.1 Säilytys ja käsittely: ........................................................................................... 30 

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