AMATECH I-LHPAFH Instrucciones De Uso página 11

INSTRUCTIONS FOR USE
2.3 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.
2.4 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.
2.5 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.
Document Number: 80028240
Version: B
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: 19 MAR 2020
Ref Blank Template: 80025118 Ver. E