AMATECH F-70300, Instructions For Use Manual, Page: 10 / 104

INSTRUCTIONS FOR USE
Document Number: D-720741
Page 10
Issue Date: 25 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
List of Accessories and Consumable Components Table:
The following list are accessories and components that may be used with this
device
Name of Accessory Product number
Accessory Cart F-30010 (US), F-30010E (EU), F30010UK (UK)
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.
Name of Consumable Product number
Comfort Mask F-70310