Stryker nGenius Universal Tracker Instructions For Use Manual

Instructions for Use

nGenius Universal Tracker

REF 6000-014-000

2007-11-21 6000-014-700 Rev. B www.stryker.com

CPT Use Only

C

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Intended Use

The nGenius Universal Tracker is part of the Stryker Navigation System. It is used in combination with the
Navigation System camera to track the position and orientation of instruments or rigid anatomical struc­tures to which the nGenius Universal Tracker may be attached via a pin or mechanical adapter.

The medical purpose is determined by the application modules. Refer to the intended use of the relevant
application module for detailed information.

User/Patient Safety

WARNINGS:

• Read and understand this information. Familiar­ization with the Stryker Navigation System prior
to use is important. Only trained personnel are to
use this system.

• The instruments should only be used in accor­dance with the instructions for use contained in
this manual by authorized persons who have
been fully trained in their safe and effective use.
The failure to follow these instructions will void
your warranty.

• Prior to each use, instruments should be opera­ted and inspected for any loose components, da­mage or malfunction. DO NOT use if any of these
conditions exist. Contact Stryker Navigation
Service immediately in such case. See contact
information in the address fi eld.

• Do not service instruments. They contain no
parts that the user can service. If service is re­quired, contact Stryker Navigation Customer
Service.

• Performing procedures with instruments other
than those specifi ed in these instructions or out-
side of their intended use compromises navigati­on accuracy.

1

Manufactured and Distributed by:

Stryker Leibinger GmbH & Co. KG
Bötzinger Straße 41
79111 Freiburg, Germany
t: [phone]

Distributed by:

Stryker Navigation
4100 East Milham Avenue
Kalamazoo, MI 49001 USA
t: [phone]
t: 800 253 3210 (toll-free within the US)

• The health care provider performing any proce­dure is responsible for determining the appro­priateness of the instruments and the specifi c
technique for each patient. Stryker, as a manuf­acturer, DOES NOT recommend surgical proce­dure.

• Clean and sterilize the nGenius Universal Tracker
before fi rst and every use as instructed in this
manual.

• This equipment is not suitable for use in the pre­sence of fl ammable anesthetic mixture with air or
with oxygen or nitrous oxide.

• Use Instrument Battery REF 6000-006-000 only.
Load a new battery before fi rst and every use as
instructed in this manual. Have several new bat­teries available.

• Remove Instrument Battery before storing or
sterilizing the nGenius Universal Tracker.

• Prior to surgery, this equipment should be
checked with the Stryker Navigation System to
ensure that it is functioning properly.

• During surgery, if fl uids such as saline solution
enter the battery holder, the electronics can fail
and communications with the system will cease.

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CAUTIONS:

• DO NOT apply any physical impact to the tracker,
especially with a mallet or similar tool. Any impact
will cause product damage or operational failure
due to battery movement.

• To avoid malfunction, DO NOT scratch or dama­ge the LEDs or photodiode covers in any way.

2

• Use only Stryker approved components and
accessories, unless otherwise specifi ed. Other
accessories may result in increased electroma­gnetic emissions or decreased electromagnetic
immunity of the system. DO NOT modify any
component or accessory. Failure to comply may
result in patient and/or health care staff injury.

• Ensure the line of sight between the tracker and
the camera is NOT blocked. The infrared Light
Emitting Diodes (LEDs) and photodiodes must be
in view of the camera for the Navigation System
to function properly.

• Excessive infrared radiation from external sour­ces can infl uence localization of the instruments
by the Navigation System. Refer to the Navigati-

on System II-Camera Instructions For Use.

• Mount and detach the tracker as instructed in this
manual.

• Attach the nGenius Universal Tracker only to
devices with a generic interface pin (see fi gure

3). Refer also to the NavLock Instructions for Use
REF 6000-999-700.

• In case of the slightest suspicion of incompati­bility or risks, do not use the nGenius Universal
Tracker.

• Ensure the generic interface pin is fully inserted
into the tracker´s notch and snaps into position.

• Take special precautions regarding electro­magnetic compatibility (EMC) when using this
medical electronic equipment. Install and put the
equipment into service according to the EMC in­formation in the EMC Specifi cations Manual REF
6000-005-760. This medical equipment meets all
requirements in the EN/IEC 60601-1-2 standard
and can be installed in a normal environment.
The equipment must not be placed or installed
close to strong electromagnetic sources which
may infl uence the function of this equipment.

• Prior to proceeding, verify that the nGenius Uni­versal Tracker is fi rmly attached to the instrument
with no movement after attachment, as instructed
in this manual. If the tracker moves relative to
the instrument, navigation is inaccurate.Fixate
the tracker again, recalibrate and re-validate the
instrument.

• To prevent incorrect treatment, regularly perform
landmark tests.

• Use the nGenius Universal Tracker only with
instruments which have less then 250 mm tip
offset.

• Always validate the instrument after calibration.

• Remove any NavLock / NavLock Lite adapter
from both tracker and instrument before cleaning
and sterilization.

• Recalibrate the instrument, if the tracker with the
instrument has been subjected to a shock.

• Avoid placing fi ngers on or near the LED domes
and keep other objects at least 25 mm away from
the LED domes when tracking.