Arthrex AR-1650S Instrucciones De Uso

Arthrex Shoulder Suspension System AR-1650S
Instructions for Use
A. Device Description
The Arthrex Shoulder Suspension System (AR-1650S) is an advanced
patient positioning system for lateral shoulder arthroscopy. The system
permits patient positioning, joint distraction and joint manipulation
allowing for arthroscopic treatment of various shoulder conditions.
The system is comprised of a Shoulder Suspension Tower, an Arm
Sleeve Connector, a Lateral Traction Sling Connector, a Weight Hanger
and a set of Weights. A Table Clamp (based on mating table rails) is also
included. The system requires the use of the Arm Sleeve Disposables
(AR-1651) and a Lateral Traction Sling Disposable (AR-1652) both
provided sterile-packaged. A Storage Cart is available to provide safe
transport and storage of the entire system. A full listing of components
and REF #'s are shown in the tables below.
C
B
H
I
Item REF
A
AR-1650-01
B
AR-1650-02
C
AR-1650-03
D
AR-1650-04
E
AR-1650-05
F*
AR-1650-06
G
AR-1650-07
H
AR-1651
I
AR-1652
* - Not shown
Manufactured For:
Arthrex, Inc.
1370 Creekside Blvd
Naples, FL 34108, USA
1-(800) 934-4404
A
D
E
G
Description
Shoulder Suspension Tower
S3 Arm Sleeve Connector
S3 Lateral Traction Sling
Connector
Weight Hanger, 10lbs (4.5kg)
Weight, 2.5lb (1.1kg) –
(5 Weights needed per system)
Storage Cart, Shoulder
Suspension System
US Clamp, Shoulder Suspension
System
Disposable, S3 Arm Sleeve
Disposable, S3 Lateral Traction
Sling
Arthrex GmbH Allen Medical Systems
Erwin-Hielscher-Strasse 9 100 Discovery Way
Acton, MA 01720
81249 München, Germany
(978) 263-5401
+49 89 909005-0
Market Specific Accessories (one required):
Item REF Description
G* *choose one clamp based on rail std.
G
AR-1650-08 EU Clamp, Shoulder Suspension System
G
AR-1650-09 UK Clamp, Shoulder Suspension System
G Denyer Clamp, Shoulder Suspension
AR-1650-10
System
G Japan Clamp, Shoulder Suspension
AR-1650-11
System
Product Specifications:
Tower Height (Opened): 62" (157.48cm) from highest point to table top
Cable Travel Range:

~26" (66cm) of horizontal travel of cable

~40" (102cm) of vertical travel of cable

40" (102cm) from center of the clamp to the furthest point of
horizontal travel

Maximum Arm Length: 34" (86cm)

Maximum Patient Weight: 400lbs (181.44kg)
B. Indications
The Arthrex Shoulder Suspension System is intended to position the patient
and apply distal limb suspension and lateral traction during lateral
arthroscopic and/or mini-open shoulder procedures.
C. Warnings
Prior to the use, ensure that the system is cleaned and is
in proper working condition.
Prior to use, ensure that the connectors (AR-1650-02 and
AR-1650-03) have been sterilized. They are provided
NON-STERILE.
Prior to using this or any other type of medical apparatus
with a patient, it is recommended that you read these
instructions and familiarize yourself with the product.
Proper understanding of appropriate surgical techniques
is required prior to using this product.
Ensure that the patient weight does not exceed the
recommended OR table and Shoulder Suspension System
specifications.
Ensure that the OR table rails are in good condition. If
they are damaged, do not mount the system to the table.
Ensure that the patient's fingers can be folded into a fist
as needed to fit into the disposable.
Failure to use this device in accordance with the
directions for use may result in device failure, render the
device unsuitable for its intended use or compromise the
procedure.
D. Precautions
1. Refer to the surgical table manufacturer's user guide for
instructions regarding the proper orientation and use of the
Hill Rom SAS
B.P. 14 Z.I. du Talhouet
56330 Pluvigner, France
Tel. +33 (0) 2 97 50 92 12
Fax. +33 (0) 2 97 50 92 12
D-720764-A2
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