Hillrom A-70801 Manuale utente

Tipo
Manuale utente
Bow Frame
Instructions for Use
Product No. A-70801
80028150
Version B
Allen® Bow Frame (A-70801)
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 2 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
ENGLISH .......................................................................................................................................... 3
中文 ........................................................................................................................................ 26
HRVATSKI ...................................................................................................................................... 49
ČESKÝ ........................................................................................................................................... 72
DANSK .......................................................................................................................................... 95
NEDERLANDS ............................................................................................................................. 118
SUOMI ......................................................................................................................................... 142
FRANÇAIS ................................................................................................................................... 165
DEUTSCH ..................................................................................................................................... 188
ΕΛΛΗΝΙΚΑ .................................................................................................................................. 211
ITALIANO .................................................................................................................................... 236
LATVISKI ...................................................................................................................................... 259
POLSKI ......................................................................................................................................... 282
PORTUGUÊS ................................................................................................................................ 305
ROMÂNESC................................................................................................................................ 329
SRPSKI ......................................................................................................................................... 352
SLOVENSKY ................................................................................................................................ 376
SLOVENŠČINA ........................................................................................................................... 399
ESPAÑOL .................................................................................................................................... 422
SVENSKA ..................................................................................................................................... 446
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 3 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
IMPORTANT NOTICES
Read and understand all warnings in this manual and on the device itself
prior to use with a patient.
The symbol is intended to alert the user to important procedures or
safety instructions regarding the use of this device.
The symbol on the labels is intended to show when the IFU should be
referenced for use.
The techniques detailed in this manual are only manufacturer’s suggestions.
The final responsibility for patient care with respect to this device remains
with the attending physician.
Device function should be checked prior to each usage.
This device should only be operated by trained personnel.
All modifications, upgrades, or repairs must be performed by an authorized
specialist.
Keep this manual available for future reference.
Any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority listed in this
document.
Prior to using this or any other type of medical apparatus with a
patient, it is recommended that you read the Instructions for Use and
familiarize yourself with the product.
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 4 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
Table of Contents
Allen® Bow Frame (A-70801)
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
2.6 Residual Risk: ............................................................................................................... 12
3 Equipment Setup and Use: ............................................................................................... 13
3.1 Prior to use: .................................................................................................................. 13
3.2 Setup: ........................................................................................................................... 13
3.3 Device controls and indicators: ............................................................................... 17
3.4 Storage, Handling and Removal Instructions: ........................................................ 20
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 5 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
3.4.1 Storage and Handling: ................................................................................... 20
3.4.2 Removal Instruction: ........................................................................................ 20
3.5 Troubleshooting Guide: ............................................................................................. 21
3.6 Device Maintenance: ............................................................................................... 21
4 Safety Precautions and General Information:............................................................... 21
4.1 General Safety Warnings and Cautions: ................................................................ 21
4.2 Product Specifications: ............................................................................................. 22
4.3 Sterilization Instruction: .............................................................................................. 23
4.4 Cleaning and Disinfection Instruction: .................................................................... 23
5 List of Applicable Standards: ........................................................................................... 23
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 6 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
1 General Information:
Allen Medical Systems, Inc. is a subsidiary of Hill-Rom, Inc., (NYSE: HRC), a leading
worldwide manufacturer and provider of medical technologies and related services
for the health care industry. As an industry leader in patient positioning, our passion is
improving patient outcomes and caregiver safety, while enhancing our customers'
efficiency. Our inspiration comes from providing innovative solutions to address our
customers' most pressing needs. We immerse ourselves in our customers' world, to
better address these needs and the daily challenges of their environment. Whether
developing a solution to address patient positioning challenges or creating a system
to offer safe and effective surgical site access for the surgical team, we are
committed to providing products of exceptional value and quality.
Allen products are backed by responsive and reliable service and complimentary on-
site product demonstrations.
1.1 Copyright Notice:
Revision
© 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: 80028150 Page 7 Issue Date: 26 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 product if the package is damaged or unintentionally opened before
use. All modifications, upgrades, or repairs must be performed by an authorized
specialist.
1.4.3 Notice to users and/or patients:
Any serious incident that has occurred in relation to the device should be reported
to the manufacturer and the competent authority of the Member State in which the
user and/or patient is established.
Note: Refer to the surgical table manufacturer's user guide for instructions on use.
Always refer to the surgical table manufacturer’s weight limits.
NEVER EXCEED THE WEIGHT CAPACITY OF THE OPERATING ROOM TABLE
(800) 433-5774
+1 978 266 4200 ext.4286
(978) 263-8846
+1 978 266 4426
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 8 Issue Date: 26 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:
Description
Reference
Indicates the device is a medical device
MDR 2017/745
Indicates the medical device manufacturer
EN ISO 15223-1
Indicates the manufacturer’s serial number.
The device serial number is encoded as
1YYWWSSSSSSS.
YY indicates the year of manufacture.
i.e. 118WWSSSSSSS where 18 represents
the year 2018.
WW indicates the number of the
manufacturing week per a standard
shop calendar. (Leading zeros
included.)
SSSSSSS is a sequential unique number.
EN ISO 15223-1
Indicates the medical device Global Trade
Item Number
21 CFR 830
MDR 2017/745
Indicates the date when the medical
device was manufactured
EN ISO 15223-1
Indicates the manufacturer’s lot code using
the Julian Date yyddd, where yy indicates
the last two digits of the year and ddd
EN ISO 15223-1
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 9 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
indicates the day of the year. i.e. April 4th,
2019 would be represented as 19094.
Indicates the manufacturer’s catalogue
number
EN ISO 15223-1
Indicates the need for the user to consult
the instructions for use for important
cautionary information such as warnings
and precautions.
EN ISO 15223-1
Indicates the device do not contain natural
rubber or dry natural rubber latex
EN ISO 15223-1
Indicates the authorized representative in
the
European Community
EN ISO 15223-1
Indicates the Medical Device complies to
REGULATION (EU) 2017/745
MDR 2017/745
Indicates a Warning
IEC 60601-1
Indicates the need for the user to consult
the instruction for use
EN ISO 15223-1
1.5.2 Intended User and Patient Population:
Intended User: Surgeons, Nurses, Doctors, Physicians and OR healthcare
professionals involved in the device intended procedure. Not intended for Lay
persons.
Intended Populations:
This device is intended to be used with patients that do not exceed the weight in the
safe working load field specified in the product specification section 4.2
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 10 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
1.5.3 Compliance with medical device regulations:
This Product is a non-invasive, Class I Medical Device. This system is CE-
marked according to Annex VIII, Rule 1, of the Medical Device
Regulations (REGULATION (EU) 2017/745)
1.6 EMC considerations:
This is not an electromechanical device. Therefore, EMC Declarations are not
applicable.
1.7 EC authorized representative:
HILL-ROM SAS
B.P. 14 - Z.I. DU TALHOUET
56330 PLUVIGNER
FRANCE
TEL: +33 (0)2 97 50 92 12
1.8 Manufacturing Information:
ALLEN MEDICAL SYSTEMS, INC.
100 DISCOVERY WAY
ACTON, MA 01720 USA
800-433-5774 (NORTH AMERICA)
978-266-4200 (INTERNATIONAL)
1.9 EU Importer Information:
TRUMPF Medizin Systeme GmbH + Co. KG
Carl-Zeiss Straße 7-9
07318 Saalfeld/Saale
Germany
1.10 Australian sponsor Information:
Welch Allyn Australia Pty. Ltd.
Unit 4.01 2-4 Lyonpark Road
Macquarie Park, NSW 2113
Phone 1800 650 083
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 11 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
2 System
2.1 System components Identification:
2.2 Product Code and Description:
A-70801 - Allen Bow frame
Pads
Pad Band
Catch
Rail Rod
Connectors
Hook/Loop Straps
Crank Handle
Pad Width Adjustment Buttons
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 12 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
2.3 List of Accessories and Consumable Components Table:
The following list are accessories and components that may be used with this
device.
Name of Accessory
Product number
Bow Frame Cart
A-70815
Crank Arm
A-70821
Note: Consult the corresponding IFU for the products mentioned in the above table.
2.4 Indication for use:
The Bow Frame is used in a variety of surgical procedures including, but not limited
to spine surgery. These devices are capable of being used with a broad patient
population as determined appropriate by the caregiver or institution.
2.5 Intended use:
The Bow Frame is designed to position and support the patient’s chest and
abdomen in a variety of surgical procedures including, but not limited to spine
surgery. These devices are intended to be used by healthcare professionals within
the Operating Room setting.
2.6 Residual Risk:
This product complies with relevant performance, safety standards. However,
device or patient harm from misuse, device, functional, device damage or
mechanical hazards cannot be completely excluded.
Name of Consumable
Product number
Not Applicable.
Not Applicable.
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 13 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
3 Equipment Setup and Use:
3.1 Prior to use:
a. Inspect the product looking for any visible damage or sharp edges that could
be caused by a drop or impact during storage.
b. Make sure product has been properly cleaned and disinfected and wiped dry
prior to each use.
c. Verify table under BowTMFrame is rated for patient weight. (If this information is
not available confirm rating with table manufacturer prior to loading a patient).
d. Verify Hook/Loop Straps are in good condition.
3.2 Setup:
a. Hold BowTM Frame above rails and verify
there is enough room to lower the Frame.
b. Lower head end of Bow Frame onto
rails and slide to desired location.
c. Ensure hook/loop straps are in between rails.
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 14 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
d. Lower Bow Frame completely onto rails.
SET-UP (COMPATIBLE RAIL SYSTEMS)
e. Bring hook/loop straps around rails and
secure to BowTM Frame.
SET-UP (OR Table / Flat Surface)
a. Hold Bow Frame above table and
verify there is enough room to lower
the frame.
b. Place Frame on OR table with
buttons facing head end OR table.
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 15 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
c. Ensure enough room for Head
Positioner.
d. Ensure Frame is centered
between OR table rails.
SET-UP (OR Table)
e. Place hook/loop straps through OR Table
Rails.
f. Bring straps around rails and secure
back to BowTM Frame.
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 16 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
LOADING THE PATIENT
Note: The techniques detailed in this manual are
only manufacturer’s suggestions. The final
responsibility for patient care with respect
to this device remains with the attending
physician.
Place moisture absorbing / friction reducing
Bow Frame Disposable Covers over the
supports.
Prior to transferring the patient, crank Bow
Frame to highest setting. After transferring the
patient, lower to desired level.
Position the patient to reduce nerve
contact and subsequent injury.
Additional support must be provided to
the head, arms and legs.
NEVER EXCEED THE WEIGHT CAPACITYOF THE O.R. TABLE.
Check all surfaces exposed to patient to ensure there is no contact with any hard
or sharp surfaces. Key areas to check are highlighted below.
Cover Cross Rod using Cross Rod Cover
Disposable or use other padding
Cover Pad Band Catch
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 17 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
3.3 Device controls and indicators:
To Adjust Pad Height
1. Insert Crank Handle into Bow Frame
as shown.
2. Press Crank Handle in until fully
engaged.
3. Support Crank Handle Rod with one
hand and grab handle with other.
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 18 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
To Adjust Pad height
4. To raise Bow Frame pads, turn the
Crank Handle counter-clockwise.
5. To lower Bow Frame pads, turn the
Crank Handle clockwise.
To adjust pad width
1. Ensure pads are at lowest height.
2. To release band, press inward at free
end of band while pulling upward at
center of band.
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 19 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
3. Pull band out from Pad Band Catch.
To adjust pad width
4. Locate Pad Width Adjustment Button
at opposite end of frame.
5. Press button firmly.
6. Shift rail laterally to desired location
and release button.
INSTRUCTIONS FOR USE
Document Number: 80028150 Page 20 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
To adjust pad width
7. Lower rail to front catch.
8. Press firmly inwards and tuck into Pad
Band Catch.
3.4 Storage, Handling and Removal Instructions:
3.4.1 Storage and Handling:
The product should be stored in a clean and safe environment to prevent product
damage.
3.4.2 Removal Instruction:
To remove from table
1. Remove hook/loop strap from
BowTM Frame and unwrap from
rail
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Hillrom A-70801 Manuale utente

Tipo
Manuale utente