Hillrom A-91501 User manual

Lift Assist Beach Chair
Instructions for Use Product
No. A-91501
D-720636
Version C

INSTRUCTIONS FOR USE
Document Number: D-720636 Page 2 Issue Date: 30 MAR 2020
Version: C Ref Blank Template: 80025117 Ver. F
ENGLISH ..........................................................................................................................................3
中文简体........................................................................................................................................35
FRANÇAIS .....................................................................................................................................68
DEUTSCH .....................................................................................................................................100
ITALIANO.....................................................................................................................................133
ESPAÑOL.....................................................................................................................................165
OTHER LANGUAGES ..................................................................................................................196

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.

INSTRUCTIONS FOR USE
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Table of Contents
Allen®Lift Assist Beach Chair (A-91501)
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:...............................................................................14
List of Accessories and Consumable Components Table:...................................14
Indication for use:.......................................................................................................15
Intended use: ..............................................................................................................15
Residual Risk:................................................................................................................15
3Equipment Setup and Use: ...............................................................................................16
Prior to use: ..................................................................................................................16
Setup: ...........................................................................................................................16
Device controls and indicators: ...............................................................................28

INSTRUCTIONS FOR USE
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Storage, Handling and Removal Instructions: ........................................................29
3.4.1 Storage and Handling:....................................................................................29
3.4.2 Removal Instruction: ........................................................................................29
Troubleshooting Guide: .............................................................................................30
Device Maintenance:................................................................................................30
4Safety Precautions and General Information:...............................................................30
General Safety Warnings and Cautions:.................................................................30
Product Specifications:..............................................................................................31
Sterilization Instruction:...............................................................................................32
Cleaning and Disinfection Instruction:.....................................................................32
5List of Applicable Standards:............................................................................................33

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 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 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

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Symbol used
Description
Reference
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
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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]

INSTRUCTIONS FOR USE
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2System
System components Identification:
Allen® Lift-Assist™ Beach Chair (Front)
FRONT
Intubation
Pad
Shoulder
Panels
Rail Clamp
Mounts
Intubation
Plate
Rail Clamp
Knobs

INSTRUCTIONS FOR USE
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Allen® Lift-Assist™ Beach Chair (back)
Head Positioner
Tube Handle
RAIL CLAMP
Top Jaw
Bottom Jaw
(hinged)
BACK
Head Positioner
Tubes
Head
Positioner
Tube Release
Beach Chair
Release Handle
Shoulder Panel
Locks
Width
Extension Knob
Support Bar

Product Code and Description:
A-91501 - Allen Lift Assist Beach Chair
A-91502 - Allen Intubation Plate and Pad
A-91503 - Allen Lift Assist Beach Chair Clamp
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
Lift-Assist Beach Chair Reusable Pad Set
Intubation Plate and Pad
Lift-Assist Beach Chair Clamp
Easy lock Socket
LPS Arm Support
Easy lock Socket
Counter Traction Strap
A-90040
Intubation Plate and Pad
A-91502
Lift-Assist Beach Chair Clamp
A-91503
Easy Lock Socket
A-40022
LPS Arm Support
A-90002
Easy Lock Socket
A-40022
Counter Traction Strap
A-90015
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
Universal Head Restraint Disposables
A-90023

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Indication for use:
The Beach Chair Shoulder Positioner is used in a variety of surgical procedures
including, but not limited to orthopedic surgeries like, rotator cuff, total shoulder,
reverse total shoulder, SLAP repair and other shoulder surgery. These devices are
capable of being used with a broad patient population as determined
appropriate by the caregiver or institution.
Intended use:
The Beach Chair Shoulder Positioner is designed to position and support the
patient’s head and torso in a variety of surgical procedures including, but not
limited to orthopedic surgeries like, rotator cuff, total shoulder, reverse total
shoulder, SLAP repair and other shoulder surgery. 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 or patient harm from misuse or device damage hazards cannot be
completely excluded.

INSTRUCTIONS FOR USE
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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.
c. Ensure surgical table is in its final operation location with respect to the room.
d. Ensure the table is locked.
e. Remove X-ray tops and back section pads from the surgical table.
f. Remove or lower the back (Preferred) or leg section of the table by 90°.
g. Loosen both rail clamp mount knobs.
Setup:
1. Unlock shoulder panel locks and remove shoulder panels as shown below by
swinging panels back and unhooking from head positioner tubes. This will make
beach chair lighter and easier to manage.

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2. Place top jaw of the rail clamp onto the torso
(seat) section of the table rail as shown.
3. Snap hinged bottom jaw onto the rail as
shown.
4. Slide rail clamp to the end of the table rail.
Preferably to rail stops.
5. Repeat steps 2-4 with second rail clamp
on opposite side of table.
6. Loosen width extension knob by turning
to the left.

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7. Fully extend width of the support bar.
8. Back-out (loosen) rail clamp knobs
completely.
9. Lift Beach Chair by placing dominant hand on the red release handle and
opposite hand on the appropriate side as shown. The non-dominant hand
should be placed well behind the rail clamp mount.

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10. Align rail clamp mounts above rail
clamps.
11. Rest rail clamp mount on edge of rail
clamp.
12. Adjust width of support bar as needed
until second rail clamp mount is correctly
aligned with second rail clamp.
13. Lower rail clamp mount onto rail clamp. Rail clamp mount should slide over rail
clamp. Do NOT force. Rail clamp mount is not installed properly until green is
visible through indicator slot and pin is flush with top (both circled).

INSTRUCTIONS FOR USE
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14. Ensure there is No Gap between the Beach
Chair and the OR table pad. Ensure blue foam
roll is hanging below the Beach Chair.
15. Tighten both rail clamp mount knobs by
turning clockwise.
16. Tighten width extension knob by turning it clockwise (to the right).