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INSTRUCTIONS FOR USE
2.3.1 Indication for use:
The Head Positioner is used in a variety of surgical procedures including, but not
limited to spine surgery. These devices are capable of being used with a broad
patient population as determined appropriate by the caregiver or institution.
2.3.2 Intended use:
The Head Positioner is designed to position and support the patient's head in a
variety of surgical procedures including, but not limited to spine surgery. These
devices are intended to be used by healthcare professionals within the Operating
Room setting.
2.4 Residual Risk:
This product complies with relevant performance, safety standards. However,
patient or device harm from misuse, device damage, device, function or
mechanical hazards cannot be completely excluded.
3
Equipment Setup and Use:
3.1 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: 80028169
Version C
Page 16
Issue Date: 26 MAR 2020
Ref Blank Template: 80025117 Ver. F
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