Manual Calibration; Intended User - Depuy Synthes SYMPHONY Bedienungsanleitung

Frequently confirm navigation accuracy during live navigation by positioning the instrument tip on
an identifiable anatomical landmark and comparing the actual tip location to that displayed by the
navigation system. Additionally, instrument accuracy can be verified using the reference frame /
Instrument Calibration Matrix (ICM).

MANUAL CALIBRATION

Prior to manually calibrating the SYMPHONY Navigation Ready Instruments, make sure that all
components (SYMPHONY Navigation Ready Instrument, Navigation Ring or Navigation Ring ST,
tracking array, reflective spheres) are rigidly connected.
Calibrate each time prior to use as no instrument geometry or dimensions are retained in the
navigation software. After calibration, the SYMPHONY Navigation Ready Instrument is shown as a
generic shape on the navigation software.
Follow the navigation manufacturer's instructions for manual calibration with the tracking arrays.
Frequently confirm navigation accuracy during live navigation by positioning the instrument tip on
an identifiable anatomical landmark and comparing the actual tip location to that displayed by the
navigation system. Additionally, instrument accuracy can be verified using the reference frame /
Instrument Calibration Matrix (ICM).
MATERIALS
The SYMPHONY Navigation Ready Instruments are manufactured from stainless steel, TiN (Titanium
Nitride Coating), TiAlN (Titanium Aluminum Nitride Coating), aluminum alloy and silicone rubber.

INTENDED USER

These devices are intended to be used by qualified health care professionals e.g. surgeons, physicians,
radiologists, operating room staff, and professionals involved in preparation of the device. All personnel
handling the device should be fully aware of the indications for use of the products.
COMBINATION OF MEDICAL DEVICES
DePuy Synthes is not the navigation system manufacturer. The SYMPHONY Navigation Ready
Instruments have been validated for use only with the Brainlab and Medtronic StealthStation
navigation systems.
The SYMPHONY Navigation Ready Instruments are compatible with UNAS. DePuy Synthes has not
tested compatibility with devices provided by other manufacturers and therefore assumes no liability
in such instances.
WARNINGS, PRECAUTIONS, AND POSSIBLE ADVERSE EFFECTS
Following are specific warnings, precautions, and possible adverse effects that should be under-
stood by the surgeon and explained to the patient. These warnings do not include all adverse effects
that can occur with surgery in general but are important considerations particular to the use of the
SYMPHONY Navigation Ready Instruments in conjunction with UNAS. General surgical risks should
be explained to the patient prior to surgery.
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