List Of Accessories And Consumable Components Table; Indication For Use; Intended Use; Residual Risk - AMATECH F-70300 Instructions D'utilisation

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
Accessory Cart
Name of Consumable
Comfort Mask
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 Head Positioner is used in a variety of surgical procedures including, but not
limited to spine surgery. These devices are capable of being used with a broad
patient population as determined appropriate by the caregiver or institution.

Intended use:

The Head Positioner is designed to position and support the patient's head in a
variety of surgical procedures including, but not limited to spine 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,
patient or device harm from misuse, device damage, device, function or
mechanical hazards cannot be completely excluded.
Document Number: 80028280
Version: B
Product number
F-30010 (US), F-30010E (EU), F30010UK (UK)
Product number
Page 11
F-70310
Issue Date: 25 MAR 2020
Ref Blank Template: 80025118 Ver. E