Arthrex Lift-Assist AR-1627 User manual

Lift-AssistTM Beach Chair
Instructions for Use
Product No. AR-1627
D-720667
Version B

INSTRUCTIONS FOR USE
Document Number: D-720667 Page 2 Issue Date: 15 APR 2020
Version: B Ref Blank Template: 80025118 Ver. D
ENGLISH ......................................................................................................................................... 3
FRANÇAIS .................................................................................................................................... 32
DEUTSCH ...................................................................................................................................... 61
ITALIANO ..................................................................................................................................... 93
ESPAÑOL ................................................................................................................................... 122
OTHER LANGUAGES ................................................................................................................. 150

INSTRUCTIONS FOR USE
Document Number: D-720667 Page 3 Issue Date: 15 APR 2020
Version: B Ref Blank Template: 80025118 Ver. D
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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Version: B Ref Blank Template: 80025118 Ver. D
Table of Contents
Lift AssistTM Beach Chair (AR-1627)
General Information........................................................................................................... 6
Copyright Notice:........................................................................................................ 6
Trademarks:............................................................................................................... 6
Contact Details:.......................................................................................................... 6
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: .................................................................................................. 7
Operating the system:................................................................................................ 7
1.5.1 Applicable Symbols:......................................................................................... 7
1.5.2 Intended User and Patient Population:............................................................. 9
1.5.3 Compliance with medical device regulations:................................................... 9
EMC considerations:.................................................................................................. 9
EC authorized representative:.................................................................................... 9
Manufacturing Information:......................................................................................... 9
System.............................................................................................................................10
System components Identification:...........................................................................10
Product Code and Description:..................................................................................12
List of Accessories and Consumable Components Table:.........................................12
Indication for use:......................................................................................................13
Intended use:............................................................................................................13
Residual risk: ............................................................................................................13
Equipment Setup and Use:...............................................................................................13
Prior to use:...............................................................................................................13
Setup: .......................................................................................................................14
Device controls and indicators:..................................................................................25
Storage, Handling and Removal Instructions:............................................................26
3.4.1 Storage and Handling: ....................................................................................26
3.4.2 Removal Instruction: .......................................................................................26
Troubleshooting Guide:.............................................................................................27

INSTRUCTIONS FOR USE
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Version: B Ref Blank Template: 80025118 Ver. D
Device Maintenance:.................................................................................................27
Safety Precautions and General Information:...................................................................27
General Safety Warnings and Cautions: ...................................................................27
Product Specifications:..............................................................................................28
Sterilization Instruction:.............................................................................................29
Cleaning and Disinfection Instruction: .......................................................................29
List of Applicable Standards:............................................................................................30

INSTRUCTIONS FOR USE
Document Number: D-720667 Page 6 Issue Date: 15 APR 2020
Version: B Ref Blank Template: 80025118 Ver. D
General Information
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 in www.allenmedical.com/pages/terms-
conditions.
Product may be covered by one or more patents. Please consult listing at
www.hill-rom.com/patents for any patent(s).
Contact Details:
For ordering information please see catalog.
customer service Information:
Address:
1370 Creekside Blvd
Naples, FL 34108
1-800-934-4404
[phone]
International
North America

INSTRUCTIONS FOR USE
Document Number: D-720667 Page 7 Issue Date: 15 APR 2020
Version: B Ref Blank Template: 80025118 Ver. D
Safety Considerations:
1.4.1 Safety hazard symbol notice:
DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE AND 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
using the contact details provided in section 1.3 of this Instruction for Use and to 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
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 your supplier 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.
EN ISO 15223-1

INSTRUCTIONS FOR USE
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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.
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, i.e. April 4th, 2019 would
be represented as 19094.
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
Intended to show when the IFU should be
referenced for use
EN ISO 15223-1

INSTRUCTIONS FOR USE
Document Number: D-720667 Page 9 Issue Date: 15 APR 2020
Version: B Ref Blank Template: 80025118 Ver. D
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)
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)

INSTRUCTIONS FOR USE
Document Number: D-720667 Page 10 Issue Date: 15 APR 2020
Version: B Ref Blank Template: 80025118 Ver. D
System
System components Identification:
FRONT
Intubation
Pad
Shoulder
Panels
Rail Clamp Mounts
Intubation Plate
Rail Clamp
Knobs
Lift-Assist™ Beach Chair (front)

INSTRUCTIONS FOR USE
Document Number: D-720667 Page 11 Issue Date: 15 APR 2020
Version: B Ref Blank Template: 80025118 Ver. D
BACK
Head
Positioner
Tubes
Head Positioner Tube
Release
Beach
Chair
Release
Handle
Shoulder Panel Locks
Width
Extension
Knob
RAIL CLAMP
Top Jaw
Bottom Jaw(hinged)
Support Bar
Head
Positioner
Tube
Handle
Lift-Assist™ Beach Chair (back)

INSTRUCTIONS FOR USE
Document Number: D-720667 Page 12 Issue Date: 15 APR 2020
Version: B Ref Blank Template: 80025118 Ver. D
Product Code and Description:
AR-1627-16 - Beach Chair Positioner
AR-1627-16W - Beach Chair Positioner, World
AR-1627-10 - Intubation Pad & Plate
AR-1627-11 - Clamp for US OR Bed Clark Rails
AR-1627-11EU - Clamp for EU OR Bed Clark Rails
AR-1627-11UK - Clamp for UK OR Bed Clark Rails
AR-1627-18 - Clamp for JP OR Bed Clark Rails
AR-1627-03 - Counter Traction Strap
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
Reusable Pad set
AR-1627-09
Intubation Plate and Pad
AR-1627-10
LPS Arm Support
AR-1627-01
Reusable Security Strap
AR-1627-15
Counter Traction Strap
AR-1627-03
Universal Head Positioner
AR-1627-05 & AR-1627-20
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
AR-1627-06

INSTRUCTIONS FOR USE
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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.
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.
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.

INSTRUCTIONS FOR USE
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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.
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.

INSTRUCTIONS FOR USE
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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.
7. Fully extend width of the support bar.
8. Back-out (loosen) rail clamp knobs
completely.

INSTRUCTIONS FOR USE
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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.
10. Align rail clamp mounts above rail
clamps.
11. Rest rail clamp mount on edge of rail
clamp.

INSTRUCTIONS FOR USE
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12. Adjust width of support bar as needed until second rail clamp mount is correctly
aligned with second rail clamp. As shown in step 11 figure.
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). As shown in
step 12 figure.
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.

INSTRUCTIONS FOR USE
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15. Tighten both rail clamp mount knobs by
turning clockwise.
16. Tighten width extension knob by turning it clockwise (to the right).
17. Replace shoulder panels by hooking the latches around the head positioner
tubes and swinging the panel forward as shown. Engage shoulder panel locks
by turning it outward.

INSTRUCTIONS FOR USE
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18. Adjust lateral position of Beach Chair by gently sliding it near the base along
support bar until desired position is achieved.
19. Turn Beach Chair release handle to the right or left. Lower Beach Chair slowly
until it lies horizontal, flush with the OR Table pad. Use head positioner handle to
assist in lowering.

INSTRUCTIONS FOR USE
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20. Transfer patient onto table in supine
position. Ensure patient’s hip is located as
shown in image (ALIGNED WITH EDGE OF
O.R. TABLE).
21. Ensure patient’s head is placed on the
intubation pad as shown below. Perform
necessary anesthetization and intubation.
22. Open head positioner tube release as shown below.