Hill-Rom Hill-Rom A-80400 Bariatric Nissen Strap/Thigh Retractors Manual de utilizare

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Manual de utilizare

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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
Document Number: 80028174 Page 3 Issue Date: 13 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: 80028174 Page 4 Issue Date: 13 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
Table of Contents
Bariatric Nissen Strap/Thigh Retractors (A-80400, A-80400E, A-80400UK)
1. General Information: ........................................................................................................... 6
1.1 Copyright Notice: ........................................................................................................ 6
1.2 Trademarks: ................................................................................................................... 6
1.3 Contact Details: ........................................................................................................... 7
1.4 Safety Considerations: ................................................................................................. 7
1.4.1 Safety hazard symbol notice: .......................................................................... 7
1.4.2 Equipment misuse notice: ................................................................................ 7
1.4.3 Notice to users and/or patients: ...................................................................... 7
1.4.4 Safe disposal: ..................................................................................................... 8
1.5 Operating the system: ................................................................................................. 8
1.5.1 Applicable Symbols:.......................................................................................... 8
1.5.2 Intended User and Patient Population: .......................................................... 9
1.5.3 Compliance with medical device regulations: .......................................... 10
1.6 EMC considerations: .................................................................................................. 10
1.7 EC authorized representative: ................................................................................. 10
1.8 Manufacturing Information: ..................................................................................... 10
1.9 EU Importer Information: ........................................................................................... 10
1.10 Australian sponsor Information: ................................................................................ 10
2 System ................................................................................................................................. 11
2.1 System components Identification: ......................................................................... 11
2.2 Product Code and Description:............................................................................... 11
2.3 List of Accessories and Consumable Components Table:................................... 11
2.4 Indication for use: ...................................................................................................... 12
2.5 Intended use: .............................................................................................................. 12
3 Equipment Setup and Use: ............................................................................................... 12
3.1 Prior to use: .................................................................................................................. 12
3.2 Setup: ........................................................................................................................... 12
3.3 Device controls and indicators: ............................................................................... 13
3.4 Storage, Handling and Removal Instructions: ........................................................ 13
3.4.1 Storage and Handling: ................................................................................... 13
INSTRUCTIONS FOR USE
Document Number: 80028174 Page 5 Issue Date: 13 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
3.4.2 Removal Instruction: ........................................................................................ 13
3.5 Troubleshooting Guide: ............................................................................................. 14
3.6 Device Maintenance: ............................................................................................... 14
4 Safety Precautions and General Information:............................................................... 14
4.1 General Safety Warnings and Cautions: ................................................................ 14
4.2 Product Specifications: ............................................................................................. 15
4.3 Sterilization Instruction: .............................................................................................. 15
4.4 Cleaning and Disinfection Instruction: .................................................................... 15
5 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
© 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.
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
Document Number: 80028174 Page 7 Issue Date: 13 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
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
Document Number: 80028174 Page 8 Issue Date: 13 MAR 2020
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
Reference
MDR 2017/745
EN ISO 15223-1
EN ISO 15223-1
21 CFR 830
MDR 2017/745
EN ISO 15223-1
INSTRUCTIONS FOR USE
Document Number: 80028174 Page 9 Issue Date: 13 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
MDR 2017/745
IEC 60601-1
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: 80028174 Page 10 Issue Date: 13 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
Document Number: 80028174 Page 11 Issue Date: 13 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
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
Not Applicable
Pad
(7” wide by 31” long)
Mounts
Strap Section
Buckle Section
INSTRUCTIONS FOR USE
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Version: B Ref Blank Template: 80025117 Ver. F
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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Version: B Ref Blank Template: 80025117 Ver. F
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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Version: B Ref Blank Template: 80025117 Ver. F
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
-29 C to +60 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
Operating Room Table Compatibility
The Bariatric Nissen Thigh Strap is
compatible with the following surgical
table rail styles: US, UK, EU
INSTRUCTIONS FOR USE
Document Number: 80028174 Page 16 Issue Date: 13 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
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 vod k použití a seznámit se s výrobkem.
NÁVOD K POUŽITÍ
Document Number: 80028174 Strana 20 Issue Date: 13 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
Obsah
Bariatric Nissen Strap/Thigh Retractors (A-80400, A-80400E, A-80400UK)
1 Obecné informace: .......................................................................................................... 22
1.1 Informace o autorských právech: ........................................................................... 22
1.2 O/chranné známky: ................................................................................................... 22
1.3 Kontaktní údaje: ......................................................................................................... 23
1.4 Bezpečnostní opatření: ............................................................................................. 23
1.4.1 Upozornění na bezpečnostním symbolu: ..................................................... 23
1.4.2 Upozornění na zneužití zařízení: ..................................................................... 23
1.4.3 Upozornění pro uživatele a/nebo pacienty: ............................................... 23
1.4.4 Bezpečná likvidace: ........................................................................................ 24
1.5 Operační systém: ....................................................................................................... 24
1.5.1 Platné symboly: ................................................................................................ 24
1.5.2 Cílová populace uživatelů a pacientů: ....................................................... 25
1.5.3 Dodržování předpisů pro zdravotnické prostředky: ................................... 26
1.6 Informace o EMC: ...................................................................................................... 26
1.7 Autorizovaný zástupce pro ES: ................................................................................. 26
1.8 Informace o výrobci: ................................................................................................. 26
1.9 Informace o dovozci do EU: ..................................................................................... 26
1.10 Informace o australském sponzorovi: ..................................................................... 26
2 Systém ................................................................................................................................. 27
2.1 Identifikace součástí systému: .................................................................................. 27
2.2 Kód a popis produktu: ............................................................................................... 27
2.3 Seznam příslušenství a tabulka spotřebních dílů: .................................................. 27
2.4 Indikace pro použití: .................................................................................................. 28
2.5 Účel použití: ................................................................................................................. 28
3 Nastavení a poití zařízení: ............................................................................................. 28
3.1 Před použitím: ............................................................................................................. 28
3.2 Nastavení: ................................................................................................................... 28
3.3 Ovládací prvky a indikátory zařízení: ...................................................................... 29
3.4 Pokyny pro skladování, manipulaci a odstranění: ................................................ 29
3.4.1 Uskladnění nebo manipulace: ...................................................................... 29
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Hill-Rom Hill-Rom A-80400 Bariatric Nissen Strap/Thigh Retractors Manual de utilizare

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Manual de utilizare
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