Clinical Benefits; Indication For Use; Intended Use; Residual Risk - Hillrom Ultrafins Stirrups Instructions D'utilisation

INSTRUCTIONS FOR USE

2.4 Clinical Benefits:

2.4.1 Indication for use:

The Stirrup is 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.

2.4.2 Intended use:

The Stirrup 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.

2.5 Residual Risk:

This product complies with relevant performance, safety standards. However,
device harm from misuse, device damage, 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. Prior to setting up the Ultrafin, assess
the patient for any pre-existing
conditions
contraindicate the use of leg
positioning devices (e.g. recent hip
surgery).
b. The Ultrafin mount to the table rails
using standard rail clamps.
Document Number: 80024545
Version: C
that might
Page 13
Issue Date: 06 MAR 2020
Ref Blank Template: Ver. F