Indication For Use; Intended Use; Residual Risk; Equipment Setup And Use - AMATECH Wingset System F-70200 Instructions D'utilisation

INSTRUCTIONS FOR USE
CAUTION: Reuse of disposables will lead to patient cross contamination and/or
device failure.

Indication for use:

The wing set is used in a variety of surgical procedures including, but not limited to
spine surgery that requires prone positioning. These devices are capable of being
used with a broad patient population as determined appropriate by the caregiver
or institution.

Intended use:

The wing set is designed to position and support the patient's chest and hip in a
variety of surgical procedures including, but not limited to spine surgery that
requires prone positioning. 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,
device harm from malfunctional or misuse 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.
Left Chest
Document Number: 80024697
Version: B
Left Hip
Page 11
Right Hip
Issue Date: 25 MAR 2020
Ref Blank Template: 80025118 Ver. E
Right Chest