AMATECH F-70801, Instructions For Use Manual, Page: 11 / 593

INSTRUCTIONS FOR USE
Document Number: 80028263
Page 11
Issue Date: 25 MAR 2020
Version: B 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
Foam Head Block Stand F-70825
Radiolucent Spine Surgery Frame Cart F-70815
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 Spine Surgery Frame 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 Spine Surgery Frame is designed to position and support the patient’s chest
and abdomen 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,
device or patient harm from misuse, device, functional, device damage or
mechanical hazards cannot be completely excluded.
Name of Consumable Product number
Spine Surgery Frame Skin Care Covers F-70810
Spine Surgery Frame Standard Covers F-70805
Foam Head Block F-70862