Hillrom A-70615-US User manual

Advanced Arm Support
Instructions for Use
Product No. A-70615-US, A-70615-EU,
A-70615-UK, A-70615-JP & A-70615-DEN
80028179
Version C

INSTRUCTIONS FOR USE
Document Number: 80028179 Page 2 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
ENGLISH.......................................................................................................................................... 3
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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®Advanced Arm Support (A-70615-US, A-70615-EU,
A-70615-UK, A-70615-JP & A-70615-DEN)
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: ............................................ 9
EMC considerations:.................................................................................................. 10
EC authorized representative: ................................................................................. 10
Manufacturing Information: ..................................................................................... 10
EU Importer Information: ........................................................................................... 10
Authorised Australian sponsor: ................................................................................. 10
2System ................................................................................................................................. 11
System components Identification:......................................................................... 11
Product Code and Description:............................................................................... 11
List of Accessories and Consumable Components Table:................................... 11
Indication for use: ...................................................................................................... 12
Intended use:.............................................................................................................. 12
3Equipment Setup and Use:............................................................................................... 12
Prior to use:.................................................................................................................. 12
Setup:........................................................................................................................... 12
Device controls and indicators:............................................................................... 15
Storage, Handling and Removal Instructions:........................................................ 15

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3.4.1 Storage and Handling: ................................................................................... 15
3.4.2 Removal Instruction:........................................................................................ 15
Troubleshooting Guide:............................................................................................. 16
Device Maintenance: ............................................................................................... 16
4Safety Precautions and General Information:............................................................... 16
General Safety Warnings and Cautions: ................................................................ 16
Product Specifications: ............................................................................................. 17
Sterilization Instruction: .............................................................................................. 18
Cleaning and Disinfection Instruction:.................................................................... 18
5List of Applicable Standards: ........................................................................................... 18

INSTRUCTIONS FOR USE
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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 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 catalogue
number
EN ISO 15223-1

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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
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)

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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 US
800-433-5774 (NORTH AMERICA)
978-266-4200 (INTERNATIONAL)
EU Importer Information:
Baxter Medical Systems GmbH + Co. KG
Carl-Zeiss Straße 7-9
07318 Saalfeld/Saale
Germany
Authorised Australian sponsor:
Welch Allyn Australia Pty. Ltd.
1 Baxter Drive
Old Toongabbie, NSW 2146
Australia

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2System
System components Identification:
Product Code and Description:
A-70615 - Advanced Arm Support
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
Clamshell Armboard Pad
O-AMA97X1.0S
Note: Consult the corresponding IFU for the products mentioned in the above table.
Name of Consumable
Product number
Not Applicable.
Not Applicable.
Clamshell
Pad
Easy LockTM
Socket
Armboard
with
Extension
Sleeve
Power
Grip
Armboard
Clamp
Support
Rod
Power
Grip

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Indication for use:
The Armboard 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.
Intended use:
The Armboard is designed to position and support the patient’s non operative arm
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.
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.
c. Ensure the patient is safely positioned on the OR table before using the
Advanced Arm Support.
Setup:
Attaching Device to Table:
a. Place unhinged jaw of the Easy Lock™
Socket onto surgical table rail.

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b. Snap hinged bottom jaw onto the rail.
Adjusting Advanced Arm Support Position:
Ensure patient and device are fully supported before adjusting any joints.
To manipulate the following device attributes, adjust Easy Lock™ Socket and
Armboard Clamp, and move components as shown in the figure below.
1. Height
2. Angle of the Support Rod
3. Lateral position
4. Radial angulation of the Armboard

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Additionally, the length of Armboard can be adjusted with the Extension Sleeve as
show:
Placing Patient in Advanced Arm Support:
a. Separate Velcro® strap of
Clamshell Pad from the Velcro®
strip on the bottom of the
Armboard.
b. Place patient’s arm on top of the
pad.

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c. Wrap the shell of the Clamshell Pad
around the patient’s arm and secure the
Velcro® strap to the bottom of the
Armboard.
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. Open Clamshell Pad and remove patient’s
arm.
If further device positioning is needed after patient placement, ensure
the arm is fully supported during movement.

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b. Loosen Power Grip on Easy Lock™ Socket and
grasp the clamp on the lower jaw to release.
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).
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. 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.
Clamp

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CAUTION:
a. Do not exceed safe working load shown in the product specification table.
b. To prevent patient and/or user injury and/or equipment damage: all modifications,
upgrades, or repairs must be performed by an Allen authorized specialist. Failure
to comply may void warranty.
Product Specifications:
Note: Consult the corresponding IFU for the products mentioned in the above table.
Mechanical Specifications
Description
Product Dimensions
Length: 17" (43.18 cm)
width: 6" (15.25 cm)
Pad Thickness:
O-AMA97X1.S0 2.5 cm (1")
O-AMA12X1.0S 2.5 cm (1")
Material
Norplex Fiber Resin Phenolic, Nylon,
Aluminum, Stainless Steel, ABS
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
-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 Advanced Arm Support is
compatible with:
Clip-on®Socket: F-ELS (US), F-40023 (EU), F-
40024 (UK), F-40030 (Japan)
Operating Room Table Compatibility
The Advanced Arm Support is compatible
with the following surgical table rail styles:
US, UK, EU, JP.

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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.
•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:
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

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Sl. no
Standards
Description
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

Advanced Arm Support
使用说明
产品编号 A-70615-US、A-70615-EU、
A-70615-UK、A-70615-JP 和A-70615-DEN
80028179
Version C