Residual Risk; Equipment Setup And Use; Prior To Use - AMATECH I-LHLMFH Instrucciones De Uso

INSTRUCTIONS FOR USE

2.6 Residual risk:

This product complies with relevant performance, safety standards. However, user
or patient harm from device, function, 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:
a. Familiarize with the product illustration "A" prior proceeding (See System
component identification section 2.1).
b. Insert the Steris boot adapter into the square rod of the LEG. Tighten the knob 1.
c. Ensure that the boot pads are in place and arranged properly. The boot straps
should be out of the way.
d. Using the knob 1, adjust the Boot position on leg to correspond to your patient's
leg length. (Slightly flex the knees). Tighten the knob 1.
e. Using LEG handles, adjust the degree of lithotomy and abduction (site
exposure) desired.
f. Loosen another knob 2 (located under the boot) and place a supporting hand
under the boot heel. Align the Boot so that is points to the patient's opposing
shoulder and retighten the knob 2. The ankle, knee, hip and opposing shoulder
should be maintained in a relative straight "line" during positioning. AVOID KNEE
ABDUCTION TO GAIN EXPOSURE. DO NOT FORCE ANY POSITION.
g. Ensure that all knobs are securely locked, and that patient's heels are properly
positioned (down) in the heel of the Boot, and that the calves are resting
passively in the Boots. Also, check to make sure Boot pads are protecting the
patient's legs.
h. Secure the Boot straps. Avoid tightening these straps against the leg. You should
be able to slip your finger between the leg and strap at the tightest point. If it is
necessary to restrain the leg more securely, i.e., for procedures involving high
lithotomy, adequate padding should be applied between the straps and the
leg.
Document Number: D-720453
Version: C
Page 12
Issue Date: 20 MAR 2020
Ref Blank Template: 80025118 Ver. E