List Of Accessories And Consumable Components Table; Indication For Use; Intended Use; Residual Risk - AMATECH BF854 Instructions D'utilisation

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
Little Clamshell Pad
Stirrup Cart
Name of Consumable
Urology / Gyn Fluid Collection System
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 Pediatric Stirrup is used in a variety of surgical procedures including, but not
limited to gynecology, urology, laparoscopy, general and robotic surgery. These
devices are appropriate for most pediatric patients ages 3-6, as determined
appropriate by the caregiver or institution.

2.5 Intended use:

The Pediatric 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 harm from misuse, device, function or mechanical hazards cannot be
completely excluded.
Document Number: 80024522
Version: A
Product Number
Product Number
F-UC4 (US), F-UC4E (EU),
F-UC4UK (UK), F-UCAJ (Japan),
F-UC4DEN (Denyer)
Page 11
F-10059
F-30015
Issue Date: 18 MAR 2020
Ref Blank Template: 80025118 Ver. E