Arthrex AR-1627-03, Instructions For Use Manual

Page: 11 / 377

INSTRUCTIONS FOR USE
Document Number: 80028275
Page 11
Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
*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.
3 Equipment Setup and Use:
Prior to use:
a. Inspect the product looking for any visible damage or sharp edges that could
be caused by a drop or impact during storage.
b. Make sure product has been properly cleaned and disinfected and wiped dry
prior to each use.
Name of Consumable Product Number
Not Applicable Not Applicable