List Of Accessories And Consumable Components Table; Indication For Use; Intended Use; Residual Risk - AMATECH F-KCP Instrucciones De Uso

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
Replacement Pads
Nissen Thigh Straps
Shoulder Supports
Urology/ Gyn Fluid Collection System
Stirrup Cart
Name of Consumable
Urology/ Gyn Fluid Collection System Drapes
Note: Consult the corresponding IFU for the products mentioned in the above table.

2.4 Indication for use:

The Knee Crutch is used in a variety of short surgical procedures including, but not
limited to cystoscopy 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 Knee Crutch is designed to position and support the patient's lower leg and
upper leg in a variety of short surgical procedures including, but not limited to
cystoscopy 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, user
or patient harm from misuse, device damage, function or mechanical hazards
cannot be completely excluded.
Document Number: 80028231
Version: B
F-UC4 (US), F-UC4E (EU), f-UC4UK (UK),
F-UC4DEN (Denyer), F-UC4J (Japan).
Page 11
Product Number
O-KCPP
F-NTS
F-63500
F-30015
Product Number
F-UC31, F-UC32
Issue Date: 19 MAR 2020
Ref Blank Template: 80025118 Ver. E