Indication For Use; Intended Use; Residual Risk; Equipment Setup And Use - AMATECH F-91501 Instrucciones De Uso

INSTRUCTIONS FOR USE

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.
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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.
Document Number:80028269
Version: C
Page 13
Issue Date: 31 MAR 2020
Ref Blank Template: 80025118 Ver. E