List Of Accessories And Consumable Components Table; Indication For Use; Intended Use; Residual Risk - Skytron Levitator III Gebrauchsanleitung

INSTRUCTIONS FOR USE

List of Accessories and Consumable Components Table:

The following list are accessories and components that may be used with this
device
Name of Accessory
Nissen Thigh Straps
Shoulder Supports
Urology/ Gyn Fluid Collection System
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.

Indication for use:

The Leg Holder 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.

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
Document Number: 80028207
Version: A
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-NTS
F-63500
F-10026
F-30015
F-10150
Issue Date: 18 MAR 2020
Ref Blank Template: 80025118 Ver. E