Hillrom A-70270 Istruzioni per l'uso

Tipo
Istruzioni per l'uso
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
Document Number: 80028170 Page 4 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117Ver. F
Table of Contents
Allen® ContourTM Breast Positioners (A-70270)
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:................................... 12
2.4 Indication for use: ...................................................................................................... 12
2.5 Intended use: .............................................................................................................. 12
3 Equipment Setup and Use: ............................................................................................... 13
3.1 Prior to use: .................................................................................................................. 13
3.2 Setup: ........................................................................................................................... 13
3.3 Device controls and indicators: ............................................................................... 14
3.4 Storage, Handling and Removal Instructions: ........................................................ 14
3.1.1 Storage and Handling: ................................................................................... 14
INSTRUCTIONS FOR USE
Document Number: 80028170 Page 5 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117Ver. F
3.1.2 Removal Instruction: ........................................................................................ 14
3.5 Troubleshooting Guide: ............................................................................................. 15
3.6 Device Maintenance: ............................................................................................... 15
4 Safety Precautions and General Information:............................................................... 15
4.1 General Safety Warnings and Cautions: ................................................................ 15
4.2 Product Specifications: ............................................................................................. 16
4.3 Sterilization Instruction: .............................................................................................. 16
4.4 Cleaning and Disinfection Instruction: .................................................................... 16
5 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
© 2019 Allen Medical Systems Inc. ALL RIGHTS RESERVED.
No part of this text shall be reproduced or transmitted in any form or by any
means, electronic or mechanical, including photocopying, recording, or by any
information or retrieval system without written permission from Allen Medical
Systems, Inc. (Allen Medical).
The information in this manual is confidential and may not be disclosed to third
parties without the prior written consent of Allen Medical.
Trademarks:
Trademark information can be found at Allenmedical.com/pages/terms-
conditions.
Products may be covered by one or more patents. Please consult listing at
Hill-rom.com/patents for any patent(s).
INSTRUCTIONS FOR USE
Document Number: 80028170 Page 7 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117Ver. F
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
Document Number: 80028170 Page 8 Issue Date: 26 MAR 2020
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:
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
Document Number: 80028170 Page 9 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117Ver. F
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
Document Number: 80028170 Page 11 Issue Date: 26 MAR 2020
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
Document Number: 80028170 Page 12 Issue Date: 26 MAR 2020
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
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
Document Number: 80028170 Page 13 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117Ver. F
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
Document Number: 80028170 Page 14 Issue Date: 26 MAR 2020
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
-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
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
Document Number: 80028170 Page 17 Issue Date: 26 MAR 2020
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)
1 Yleistä tietoa: ...................................................................................................................... 22
1.1 Tekijänoikeusilmoitus: ................................................................................................. 22
1.2 Tavaramerkit: .............................................................................................................. 22
1.3 Yhteystiedot: ............................................................................................................... 23
1.4 Turvallisuutta koskevat huomiot: .............................................................................. 23
1.1.1 Turvallisuusriskin osoittavaa symbolia koskeva huomautus: ...................... 23
1.1.2 Laitteen vääränlaista käyttöä koskeva huomautus: .................................. 23
1.1.3 Huomautus käyttäjille ja/tai potilaille: ........................................................... 23
1.1.4 Turvallinen hävittäminen: ............................................................................... 24
1.5 Järjestelmän käyttö: .................................................................................................. 24
1.1.5 Sovellettavat symbolit: .................................................................................... 24
1.1.6 Kohdekäyttäjät ja potilaspopulaatio: .......................................................... 25
1.1.7 Lääkinnällisiä laitteita koskevien asetusten noudattaminen: .................... 26
1.6 Sähkömagneettista yhteensopivuutta koskevat huomiot: .................................. 26
1.7 Valtuutettu edustaja Euroopan yhteisössä: ........................................................... 26
1.8 Valmistustiedot: .......................................................................................................... 26
1.9 Maahantuoja EU-alueella: ........................................................................................ 26
1.10 Edustaja Australiassa: ................................................................................................ 26
2 Järjestelmä ......................................................................................................................... 27
1.11 Järjestelmän osien tunnistaminen: .......................................................................... 27
1.12 Tuotekoodi ja tuotteen kuvaus: ............................................................................... 27
1.13 Luettelo lisävarusteista ja kulutusosista:................................................................... 28
1.14 Käyttöaihe: .................................................................................................................. 28
1.15 Käyttötarkoitus: ........................................................................................................... 28
3 Laitteen asennus ja käyttö: .............................................................................................. 29
1.16 Ennen käyttöä: ........................................................................................................... 29
1.17 Asennus: ...................................................................................................................... 29
1.18 Laitteen säätimet ja merkinnät: ............................................................................... 30
1.19 Säilytys-, käsittely- ja irrotusohjeet: ........................................................................... 30
3.1.1 Säilytys ja käsittely: ........................................................................................... 30
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Hillrom A-70270 Istruzioni per l'uso

Tipo
Istruzioni per l'uso