Intended Use; Residual Risk; Equipment Setup And Use; Prior To Use - AMATECH F-LHLEV3M Instructions D'utilisation

INSTRUCTIONS FOR USE

Intended use:

The Leg Holder is designed to position and support the patient's foot, lower leg and
upper leg in a variety of surgical procedures including, but not limited to gynecology,
urology, laparoscopy, general and robotic 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,
patient harm from misuse, device, function or mechanical hazards cannot be
completely excluded
3

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.

Setup:

1. The stirrups mount to the table rails using standard rail clamps.
2. Locate clamps adjacent to the patient's hip joint. The boots are marked (on
the bottom) for the patient's left and right.
Document Number: 80024541
Version: B
Page 12
Issue Date: 18 MAR 2020
Ref Blank Template: 80025118 Ver. E