List Of Accessories And Consumable Components Table; Indication For Use; Intended Use; Residual Risk - AMATECH Bariatric Armboard F-80200 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
Note: Consult the corresponding IFU for the products mentioned in the above table.

Indication for use:

The Armboard 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 Armboard is designed to position and support the patient's non-operative arm
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, patient harm from misuse, device damage or functional hazards cannot be
completely excluded.
Document Number: 80028256
Version: B
N/A
Page 11
Product Number
F-30010 (US)
F-30010E (EU)
F-30010UK (UK)
Product Number
N/A
Issue Date: 18 MAR 2020
Ref Blank Template: 80025118 Ver. E