Indication For Use; Intended Use; Residual Risk - AMATECH F-70100 Instructions D'utilisation

INSTRUCTIONS FOR USE

Indication for use:

The Flex Frame is used in a variety of surgical procedures including, but not limited to
spine, cranial, cervical surgery and/or surgery that requires prone, lateral and supine
positioning. These devices are capable of being used with a broad patient
population as determined appropriate by the caregiver or institution.

Intended use:

The Flex frame is designed to position and support the patient's head, chest, arms,
abdomen and hip in a variety of surgical procedures including, but not limited to
spine, cranial, cervical surgery and/or surgery that requires prone, lateral and supine
positioning. 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
harm from misuse, device damage or mechanical hazards cannot be completely
excluded.
Document Number: 80028211
Version: A
Page 14
Issue Date: 25 MAR 2020
Ref Blank Template: 80025118 Ver. E