Indication For Use; Intended Use; Residual Risk; Equipment Setup And Use - AMATECH F-LH720 Manual Del Usuario

INSTRUCTIONS FOR USE
Name of Accessory
Urology/Gyn Fluid Collection System
Bariatric Nissen Thigh Straps
Polymer Gel Boot Pads
Stirrup Cart
Name of Consumable
Urology/Gyn Fluid Collection System Drapes
Egg Crate foam
Note: Consult the corresponding IFU for the products mentioned in the above table.
CAUTION: Reuse of disposables will lead to patient cross contamination and/or
device failure.

2.4 Indication for use:

The Leg Holders are used in a variety of surgical procedures including, but not limited
to gynecology, urology, laparoscopy, general and robotic 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 Leg Holders are 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.

2.6 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:

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.
Document Number: D-720378
Version: C
Product Number
F-UC4 (US), F-UC4E (EU), F-UC4UK (UK),
F-UC4DEN (Denyer), F-UC4J (Japan)
Product Number
F-UC31, F-UC32
Page 11
F-NTSHD
F-10026
F-30015
F-10150
Issue Date: 19 MAR 2020
Ref Blank Template: 80025118 Ver. E