Safety Precautions And General Information; General Safety Warnings And Cautions - Arthrex AR-1650S Gebrauchsanleitung

INSTRUCTIONS FOR USE
4

Safety Precautions and General Information:

4.1 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.
e. Prior to the use, ensure that the system is cleaned and is in proper working
condition.
f. Prior to use, ensure that the connectors (AR-1650-02 and AR-1650-03) have been
sterilized. They are provided NON-STERILE.
g. Proper understanding of appropriate surgical techniques is required prior to using
this product.
h. Ensure that the patient weight does not exceed the recommended OR table and
Shoulder Suspension System specifications.
i. Ensure that the OR table rails are in good condition. If they are damaged, do not
mount the system to the table.
j. Ensure that the patient's fingers can be folded into a fist as needed to fit into the
disposable.
k. 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.
CAUTION:
a. Refer to the surgical table manufacturer's user guide for instructions regarding
the proper orientation and use of the table. Always refer to the surgical table
manufacturer's weight limits.
b. Ensure that the OR table is locked prior to mounting the Shoulder Suspension
System.
Document Number: 80028287
Version: B
Page 34
Issue Date: 27 MAR 2020
Ref Blank Template: 80025118 Ver. E