www.stryker.com
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 struc-
tures 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. Familiar-
ization 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 accor-
dance 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 opera-
ted and inspected for any loose components, da-
mage 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 re-
quired, 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 navigati-
on accuracy.
1
Manufactured and Distributed by:
Stryker Leibinger GmbH & Co. KG
Bötzinger Straße 41
79111 Freiburg, Germany
t: +49 761 4512-0
Distributed by:
Stryker Navigation
4100 East Milham Avenue
Kalamazoo, MI 49001 USA
t: +1 269 323 7700
t: 800 253 3210 (toll-free within the US)
• The health care provider performing any proce-
dure is responsible for determining the appro-
priateness of the instruments and the specifi c
technique for each patient. Stryker, as a manuf-
acturer, DOES NOT recommend surgical proce-
dure.
• 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 pre-
sence 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 bat-
teries 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.
