Indication For Use; Intended Use; Residual Risk; Equipment Setup And Use - Arthrex AR-1650S Instrucciones De Uso

INSTRUCTIONS FOR USE

2.4 Indication for use:

The Shoulder Suspension Tower is used in a variety of surgical procedures
including, but not limited to lateral arthroscopic and mini-open shoulder surgery.
These devices are capable of being used with a broad patient population as
determined appropriate by the caregiver or institution.

2.5 Intended use:

The Shoulder Suspension Tower is designed to position, support and/or distract the
patient's shoulder in a variety of surgical procedures including, but not limited to
lateral arthroscopic and mini-open shoulder surgery. These devices are intended
to be used by healthcare professionals within the Operating Room setting.

2.6 Residual risk:

This product complies with relevant performance, safety standards. However, User,
patient or device harm from misuse, device damage, function, unavailability or
mechanical hazards cannot be completely excluded.
3

Equipment Setup and Use:

3.1 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.

3.2 Setup:

Note: Ensure that the surgical table is in its final operation location with
respect to the room.
Note: Remove X-ray tops if present from the surgical table.
Note: Ensure that the longest part of the surgical table base is located under
the Suspension System attachment location for greatest table stability.
Document Number: D-720764
Version: C
Page 15
Issue Date: 27 MAR 2020
Ref Blank Template: 80025118 Ver. E