Indication For Use; Intended Use; Residual Risk; Equipment Setup And Use - AMATECH F-PRSLH Instrucciones De Uso

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 Restraint Strap is used in a variety of surgical procedures including, but not
limited to spine and orthopedic surgery. These devices are capable of being used
with a broad patient population as determined appropriate by the caregiver or
institution.

Intended use:

The Restraint Strap is designed to safely hold the patient in a variety of surgical
procedures including, but not limited to spine and orthopedic 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 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.
Document Number: 80028309
Version: B
Product Number
Nor Applicable
Page 11
Issue Date: 31 MAR 2020
Ref Blank Template: 80025118 Ver. E