Indication For Use; Intended Use; Residual Risk - Stryker F-SFFFBER Instrucciones De Uso

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: 80028282
Version: B
Page 14
Issue Date: 15 APR 2020
Ref Blank Template: 80025118 Ver. E