List Of Accessories And Consumable Components Table; Indication For Use; Intended Use; Residual Risk - AMATECH F-70801 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
Foam Head Block Stand
Radiolucent Spine Surgery Frame Cart
Name of Consumable
Spine Surgery Frame Skin Care Covers
Spine Surgery Frame Standard Covers
Foam Head Block
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.

2.4 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.

2.5 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

2.6 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.
Document Number: D-720640
Version: D
Product number
Product number
Page 11
F-70825
F-70815
F-70810
F-70805
F-70862
Issue Date: 16 AUG 2021
Ref Blank Template: 80025118 Ver. E