The user or patient must report any serious product-related incident to both the
manufacturer and the national competent authority where the user or patient is
established.
2.1. User group
Healthcare professionals (surgeon, resident, nurse, professional caregiver) educated in
computer-assisted surgery and thoroughly familiar with the instructions for use and with
the operation of this product. To request additional in-service instruction, contact Stryker.
2.2. Indications for use and contraindications
United States and Canada*
Refer to the user manual supplied with the Cranial Guidance Software for system
indications and contraindications.
Rest of World*
The Universal Base Skull is indicated for use as an accessory to the Cranial Guidance
Software. It is intended for fixation of the Patient Tracker Advanced to the patient.
The system is indicated as an aid for locating anatomical structures in either open
or percutaneous neurosurgical procedures. The system is indicated for any medical
condition in which the use of computer-assisted surgery may be appropriate and where
reference to a rigid anatomical structure can be identified.
Contraindications: None known.
EN
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