Hillrom A-70200 User manual

Standard Wing Set System
Instructions for Use
Product No. A-70200, A-70201 & A-70202
80028165
Version B

INSTRUCTIONS FOR USE
Document Number: 80028165 Page 2 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
ENGLISH ........................................................................................................................................ 3
中文简体 ........................................................................................................................................................ 22
NEDERLANDS ............................................................................................................................. 58
SUOMI ......................................................................................................................................... 77
FRANÇAIS ................................................................................................................................... 95
DEUTSCH ................................................................................................................................... 113
ΕΛΛΗΝΙΚΑ ................................................................................................................................ 131
ITALIANO .................................................................................................................................. 151
LATVISKI .................................................................................................................................... 169
NORSK ...................................................................................................................................... 187
POLSKI ....................................................................................................................................... 206
PORTUGUÊS .............................................................................................................................. 225
ROMÂNESC .............................................................................................................................. 244
SRPSKI ....................................................................................................................................... 263
SLOVENSKY .............................................................................................................................. 282
SLOVENŠČINA ......................................................................................................................... 302
ESPAÑOL .................................................................................................................................. 320
SVENSKA ................................................................................................................................... 338

INSTRUCTIONS FOR USE
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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.

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Table of Contents
Allen®Standard Wing Set System (A-70200, A-70201, A-70202)
1General Information:........................................................................................................... 6
Copyright Notice: ........................................................................................................ 6
Trademarks:................................................................................................................... 6
Contact Details: ........................................................................................................... 7
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
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
EMC considerations:.................................................................................................. 10
EC authorized representative: ................................................................................. 10
Manufacturing Information: ..................................................................................... 10
EU Importer Information: ........................................................................................... 10
Australian sponsor Information:................................................................................ 10
2System ................................................................................................................................. 12
System components Identification:......................................................................... 12
Product Code and Description:............................................................................... 12
List of Accessories and Consumable Components Table:................................... 12
Indication for use: ...................................................................................................... 13
Intended use:.............................................................................................................. 13
Residual Risk:............................................................................................................... 13
3Equipment Setup and Use:............................................................................................... 14
Prior to use:.................................................................................................................. 14
Setup:........................................................................................................................... 14
Device controls and indicators:............................................................................... 17

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Storage, Handling and Removal Instructions:........................................................ 17
3.4.1 Storage and Handling:.........................................................................................17
3.4.2 Removal Instruction:.............................................................................................17
Troubleshooting Guide:............................................................................................. 17
Device Maintenance: ............................................................................................... 17
4Safety Precautions and General Information:............................................................... 18
General Safety Warnings and Cautions: ................................................................ 18
Product Specifications: ............................................................................................. 18
Sterilization Instruction: .............................................................................................. 19
Cleaning and Disinfection Instruction:.................................................................... 19
5List of Applicable Standards: ........................................................................................... 20

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1General 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).

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International
North America
Contact Details:
For ordering information please see catalog.
Allen Customer Service Contact Information:
Safety Considerations:
1.4.1 Safety hazard symbol notice:
DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE OR MATERIAL
DEGRADATION.
1.4.2 Equipment misuse notice:
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
[phone]
[phone] ext.4286
[phone]
[phone]

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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.
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 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 indicates the day of the year.
EN ISO 15223-1

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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

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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)
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: [phone]
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

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Phone [phone]

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2System
System components Identification:
A. Hip Support
B. Chest Support
C. Hip Pad, Left
D. Hip Pad, Right
E. Hip Pad, Centre
F. Chest Pad, Left
G. Chest Pad, Right
H. Chest Pad, Centre
Product Code and Description:
A-70200 - Allen Standard Wing Set System
A-70201 - Allen Cut-out Wing Set
A-70202 - Allen Pediatric Wing Set
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.
Name of Consumable
Product number
Comfort Cover Disposables
A-70260
B
A
D
C
E
F
G
H

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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 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.
Residual Risk:
This product complies with relevant performance, safety standards. However,
device harm from malfunctional or misuse hazards cannot be completely
excluded.

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3Equipment 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.
Symbols:
Setup:
a. Place the Allen Wing sets on the Allen Flex Frame. The indicated labels denote
the proper orientation of the pads.
Left Chest
Left Hip
Right Hip
Right Chest

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b. To match up the pads, hold the
pad upside down and match
the images as shown.
c. Attach the pads with the inside
edge first and then pull the skirt
around the bottom.
Installation
d. Adjust the location to the desired
spacing for each patient.
e. Push down firmly on the clamp
latch to lock the Wing Sets into
place.
f. Pull outward on the clamp latch
to ensure the clamp is locked.
Inside Edge
Skir
t

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Adjust the width
g. Push down the locking level to
unlock the Wing Set supports.
h. Adjust the Wing Set supports to the
desired width. Remove the center
pads if further inward adjustment is
needed. Slightly nudge the
supports to free the internal brake
pads if needed.
i. Push up the locking levels to lock
the Wing Set supports.
Loading the patient:
j. Place moisture
absorbing/friction reducing
covers over the supports.
k. Transfer the patient onto the
Wing Sets. Position the
patient to reduce nerve
contact and subsequent
injury. Additional support
must be provided to the
head, arms, and legs. It is
recommended that Leg
Support pads be used to
elevate the legs.
Wing Set Hydrophilic
Disposable
Allen Spinal Leg Supports
Prone Arm Supports
Allen Flex Frame
Allen C-Prone Head Positioner

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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:
a. Push the white clamp locks
down to unlock.
b. Pull up firmly on the clamp latch
to release.
c. Remove the device.
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).

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4Safety 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. Prior to using this or any other type of medical apparatus, it is recommended that
you read the Instructions for Use and familiarize yourself with the product prior to
application on a patient.
e. Do not use if product shows visible damage.
f. Do not exceed 500 lbs. (226 kg) patient weight limit.
g. To reduce the chances of patient tissue damage, care should be taken to ensure
proper orientation and location of supports.
h. To reduce the chances of skin maceration and shear, it is recommended that a
disposable cover be used between the patient and the pads.
i. To avoid injury to patient, ensure Wing Sets are properly latched and locked prior
to loading a patient.
j. To avoid serious injury to patient, additional restraints must be used to securely
restrain the patient to the OR table prior to tilting the system.
k. All modifications, upgrades, or repairs must be performed by an authorized
specialist.
CAUTION:
Do not exceed safe working load shown in the product specification table.
Product Specifications:
Mechanical Specifications
Description
Product Dimensions
Width Adjustable from:
10" to 18" (25.4cm to 45.7cm) Applies to
A-70200, A-70202, A-70203, A-70204 &
A-70205

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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.
16" to 18" (40.6cm to 45.7cm ) Applies
to A-70201& A-70206
Material
Polyethylene , Urethane, Acetal, Nylon,
High Density Foam, Low Density Foam ,
Acrylonitrile-Butadiene-Styrene, Garolite
Safe Working Load on the device
500 lbs. (226 kg)
Overall Weight of Complete Device
8 lbs.(3.6 kg)
Storage Specifications
Description
Storage temperature
-29ᵒC to +60ᵒC
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 Standard Wing Set System 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

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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
5List of Applicable Standards:
SI. 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