Hill-Rom A-80400 Bariatric Nissen Strap/Thigh Retractors Používateľská príručka

Bariatric Nissen Strap/Thigh Retractors

Instructions for Use

Product No. A-80400, A-80400E, A-80400UK

80028174

Version B

INSTRUCTIONS FOR USE         
Document Number: 80028174 Page 2  Issue Date: 13 MAR 2020 
                      
Version: B    Ref Blank Template: 80025117 Ver. F 
 
ENGLISH  ........................................................................................................................................  3 
 
ČESKÝ  .........................................................................................................................................  19 
 
DANSK  ........................................................................................................................................  34 
 
FRANÇAIS  ...................................................................................................................................  49 
 
DEUTSCH .....................................................................................................................................  66 
 
ΕΛΛΗΝΙΚΑ  ..................................................................................................................................  82 
 
ITALIANO  ....................................................................................................................................  98 
 
LATVISKI  ....................................................................................................................................  114 
 
ROMÂNESC ..............................................................................................................................  129 
 
SRPSKI  .......................................................................................................................................  146 
 
SLOVENSKY  ..............................................................................................................................  162 
 
SLOVENŠČINA  .........................................................................................................................  178 
 
ESPAÑOL ...................................................................................................................................  194 
 
SVENSKA  ...................................................................................................................................  210

INSTRUCTIONS FOR USE

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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         
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Version: B    Ref Blank Template: 80025117 Ver. F 
Table of Contents 
Bariatric Nissen Strap/Thigh Retractors (A-80400, A-80400E, A-80400UK) 
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:................................... 11 
4 Indication for use: ...................................................................................................... 12 
5 Intended use: .............................................................................................................. 12 
Equipment Setup and Use: ............................................................................................... 12 
1 Prior to use: .................................................................................................................. 12 
2 Setup: ........................................................................................................................... 12 
3 Device controls and indicators: ............................................................................... 13 
4 Storage, Handling and Removal Instructions: ........................................................ 13 
4.1 Storage and Handling: ................................................................................... 13 

INSTRUCTIONS FOR USE         
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Version: B    Ref Blank Template: 80025117 Ver. F 
4.2 Removal Instruction: ........................................................................................ 13 
5 Troubleshooting Guide: ............................................................................................. 14 
6 Device Maintenance: ............................................................................................... 14 
Safety Precautions and General Information:............................................................... 14 
1 General Safety Warnings and Cautions: ................................................................ 14 
2 Product Specifications: ............................................................................................. 15 
3 Sterilization Instruction: .............................................................................................. 15 
4 Cleaning and Disinfection Instruction: .................................................................... 15 
List of Applicable Standards: ........................................................................................... 16 
 
   

INSTRUCTIONS FOR USE

Document Number: 80028174 Page 6 Issue Date: 13 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 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

(800) 433-5774

+1 978 266 4200 ext.4286

(978) 263-8846

+1 978 266 4426

INSTRUCTIONS FOR USE

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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 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

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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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2 System

2.1 System components Identification:

2.2 Product Code and Description:

A-80400 - Bariat Nissen Straps / Thigh Retrac, US

A-80400E - Bariat Nissen Straps/Thigh Retrac, EU

A-80400UK - Bariatric Nissen Straps/Thigh Retrac, UK

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

Accessory Cart

A-30010 (US), A-30013E (EU),

A-30010UK (UK), A-30010J (Japan)

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

Name of Consumable

Product Number

Not Applicable

Pad

(7” wide by 31” long)

Mounts

Strap Section

Buckle Section

INSTRUCTIONS FOR USE

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2.4 Indication for use:

The Nissen strap is used in a variety of surgical procedures including, but not limited

to gynecology, urology, laparoscopy, general and robotic surgery during Reverse

Trendelenburg positioning. 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 Nissen strap is designed to position and support the patient’s upper leg in a

variety of surgical procedures including, but not limited to gynecology, urology,

laparoscopy, general and robotic surgery during Reverse Trendelenburg positioning.

These devices are intended to be used by healthcare professionals within the

Operating Room setting.

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.

3.2 Setup:

a. Position the Strap Mount on the table rail adjacent to the patient’s thigh. Tighten.

b. Pull the strap under and around the patient’s thigh. The pad must be between

the thigh and the strap encircling the thigh.

INSTRUCTIONS FOR USE

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c. Position the buckle mount 150mm (6”) from the strap mount on the table rail

toward the head end of the table. Tighten.

d. Pull the strap through the buckle until it is taut, and the patient is held on the

table. Lock by pressing the buckle latch to the closed position.

e. Repeat steps a. through d. for the other strap.

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.

3.4.2 Removal Instruction:

a. Loosen the strap from the buckle.

b. Loosen the buckle section mount knob and remove mount.

c. Release the patient thigh and remove the strap section mount.

Strap Section &

Mount

Buckle

Buckle Section &

Mount

INSTRUCTIONS FOR USE

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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:

Periodic Maintenance is not required for this device.

4 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. Do not attach strap to any type of table width extender as patient injury could

result

CAUTION:

a. Do not over-tighten straps around patient’s legs as injury may result.

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

INSTRUCTIONS FOR USE

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4.2 Product Specifications:

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.

4.4 Cleaning and Disinfection Instruction:

WARNING:

Mechanical Specifications

Description

Product Dimensions

Pad Dimension 79 cm x 18 cm (31” x 7”)

(L x W)

Material

Aluminum, Conductive strap, Viscoelastic

Foam, Fusion 3, Black, Lectrolite Fusion

3HP, Black, Lectrolite Duotone, Black,

Vinyl-nitrile rubber

Safe Working Load on the device

1.000 lbs. (453.5 kg)

Overall Weight of Complete Device

3.6 lbs. (1.63 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

Operating Room Table Compatibility

The Bariatric Nissen Thigh Strap is

compatible with the following surgical

table rail styles: US, UK, EU

INSTRUCTIONS FOR USE

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 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

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

INSTRUCTIONS FOR USE

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7

ISTA

International Safe Transit Association standards

for package testing

Bariatric Nissen Strap/Thigh Retractors

Návod k použití

Č. výrobku A-80400, A-80400E, A-80400UK

80028174

Version B

NÁVOD K POUŽITÍ

Document Number: 80028174 Strana 19 Issue Date: 13 MAR 2020

Version: B Ref Blank Template: 80025117 Ver. F

DŮLEŽITÁ UPOZORNĚNÍ

• Přečtěte si veškerá varování uvedená v tomto návodu a na zařízení dříve,

než ho začnete používat s pacientem.

• Symbol má upozornit uživatele na důležité postupy nebo bezpečnostní

pokyny týkající se používání tohoto zařízení.

Symbol na štítcích upozorňuje na nutnost použití návodu k obsluze.

• Techniky uváděné v této příručce slouží pouze jako doporučení ze strany

výrobce. Odpovědnost za péči o pacienta pokud jde o toto zařízení nese

vždy vyšetřující lékař.

• Funkci zařízení je třeba před každým použitím zkontrolovat.

• Toto zařízení smí obsluhovat pouze vyškolený personál.

• Veškeré jeho úpravy, vylepšení nebo opravy je nutné svěřit autorizovanému

odborníkovi.

• Uchovejte tuto příručku pro budoucí použití.

• Jakákoli závažná událost, která se vyskytla v souvislosti se zařízením, by měla

být nahlášena výrobci a příslušnému orgánu uvedenému v tomto

dokumentu.

Dříve než začnete používat tento nebo jiný typ

zdravotnického přístroje s pacientem, doporučujeme vám

prostudovat si Návod k použití a seznámit se s výrobkem.

NÁVOD K POUŽITÍ         
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Version: B    Ref Blank Template: 80025117 Ver. F 
Obsah 
Bariatric Nissen Strap/Thigh Retractors (A-80400, A-80400E, A-80400UK) 
Obecné informace: .......................................................................................................... 22 
1 Informace o autorských právech: ........................................................................... 22 
2 O/chranné známky: ................................................................................................... 22 
3 Kontaktní údaje: ......................................................................................................... 23 
4 Bezpečnostní opatření: ............................................................................................. 23 
4.1 Upozornění na bezpečnostním symbolu: ..................................................... 23 
4.2 Upozornění na zneužití zařízení: ..................................................................... 23 
4.3 Upozornění pro uživatele a/nebo pacienty: ............................................... 23 
4.4 Bezpečná likvidace: ........................................................................................ 24 
5 Operační systém: ....................................................................................................... 24 
5.1 Platné symboly: ................................................................................................ 24 
5.2 Cílová populace uživatelů a pacientů: ....................................................... 25 
5.3 Dodržování předpisů pro zdravotnické prostředky: ................................... 26 
6 Informace o EMC: ...................................................................................................... 26 
7 Autorizovaný zástupce pro ES: ................................................................................. 26 
8 Informace o výrobci: ................................................................................................. 26 
9 Informace o dovozci do EU: ..................................................................................... 26 
10 Informace o australském sponzorovi: ..................................................................... 26 
Systém ................................................................................................................................. 27 
1 Identifikace součástí systému: .................................................................................. 27 
2 Kód a popis produktu: ............................................................................................... 27 
3 Seznam příslušenství a tabulka spotřebních dílů: .................................................. 27 
4 Indikace pro použití: .................................................................................................. 28 
5 Účel použití: ................................................................................................................. 28 
Nastavení a použití zařízení: ............................................................................................. 28 
1 Před použitím: ............................................................................................................. 28 
2 Nastavení: ................................................................................................................... 28 
3 Ovládací prvky a indikátory zařízení: ...................................................................... 29 
4 Pokyny pro skladování, manipulaci a odstranění: ................................................ 29 
4.1 Uskladnění nebo manipulace: ...................................................................... 29 

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