Indication For Use; Intended Use; Residual Risk - AMATECH P056397948 Mode D'emploi

INSTRUCTIONS FOR USE
Name of Consumable
Not Applicable
*Note: Consult the corresponding IFU for the products mentioned in the above table.

Indication for use:

The Counter Traction Strap is used in a variety of surgical procedures including, but
not limited to orthopedic surgery while traction is applied to the arm of the operative
side. These devices are capable of being used with a broad patient population as
determined appropriate by the caregiver or institution.

Intended use:

The Counter Traction Strap is designed to safely hold the patient's torso and arm in a
variety of surgical procedures including, but not limited to orthopedic surgery while
traction is applied to the arm of the operative side. 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 or device damage hazards cannot be completely
excluded.
Document Number: 80024696
Version: C
Product Number
Page 11
Issue Date: 30 MAR 2020
Ref Blank Template: 80025118 Ver. E