List Of Accessories And Consumable Components Table; Indication For Use; Intended Use; Residual Risk - AMATECH F-93000 Mode D'emploi

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
Not Applicable
Name of Consumable
Traction Boot Disposable
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 Quick Release with Traction Boot is used for hip surgery. These devices are
capable of being used with a broad patient population as determined
appropriate by the caregiver or institution.

Intended use:

The Quick Release with Traction Boot is designed to position, support and/or distract
the patient's foot for hip 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, user
harm from functional, device damage or mechanical hazard cannot be
completely excluded.
Document Number: 80028279
Version: B
Product Number
Not Applicable
Product Number
Page 11
F-93004
Issue Date: 31 MAR 2020
Ref Blank Template: 80025118 Ver. E