List Of Accessories And Consumable Components Table; Indication For Use; Intended Use; Residual Risk - AMATECH F-PRS 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
Accessory Cart
Name of Consumable
Not Applicable
*Note: Consult the corresponding IFU for the products mentioned in the above table.

2.4 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.

2.5 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.

2.6 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: 80028236
Version: B
Product Number
F-30010 (US), F-30010E (EU), F-30010UK (UK)
Product Number
Not Applicable
Page 11
Issue Date: 30 MAR 2020
Ref Blank Template: 80025118 Ver. E