Indication For Use; Intended Use; Residual Risk; Equipment Setup And Use - AMATECH F-UPBLC Manual Del Usuario

INSTRUCTIONS FOR USE
Name of Consumable
Not Applicable
Note: Consult the corresponding IFU for the products mentioned in the above table.

2.4 Indication for use:

The Lateral Brace is used in a variety of surgical procedures including, but not limited
to arthroscopic or open Orthopedic 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 Lateral Brace is designed to Stabilize the patient on OR table in a variety of
surgical procedures including, but not limited to arthroscopic or open Orthopedic
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,
patient, user or device harm from misuse, device damage or malfunction, device,
function or mechanical hazards cannot be completely excluded.

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:

a. Position the Rail Clamp adjacent to the patient's anatomy requiring support.
b. Install the Support Post into the Rail Clamp, adjust it to the desired height and
c. securely lock Rail Clamp in place.
d. Unlock the Brace Lock Handle and position the Brace Head securely against
Document Number: 80028299
Version: B
Product Number
Not Applicable
Page 12
Issue Date: 27 MAR 2020
Ref Blank Template: 80025118 Ver. E