AMATECH F-LHPBMAQNP, Instructions For Use Manual, Page: 11 / 451

INSTRUCTIONS FOR USE
Document Number: 80028205
Page 11
Issue Date: 10 AUG 2021
Version: B Ref Blank Template: 80025118 Ver. E
Name of Accessory Product Number
Nissen Thigh Straps F-NTS
Shoulder Supports F-63500
Urology/ Gyn Fluid Collection System
F-UC4 (US), F-UC4E (EU), F-UC4UK (UK),
F-UC4DEN (Denyer), F-UC4J (Japan)
Polymer Gel Boot Pads F-10026
Stirrup Cart F-30015
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 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.
2.5 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.
2.6 Residual risk:
This product complies with relevant performance, safety standards. However,
patient or device harm from misuse, device damage, function or mechanical
hazards cannot be completely excluded.
Name of Consumable Product Number
Urology/ Gyn Fluid Collection System Drapes F-UC31, F-UC32
Egg Crate foam F-10150