Civco omniTRAX Handbuch Seite 3

omniTRAX
TM
INDICATIONS FOR USE / INTENDED USE
• The device is intended to provide physicians with a tool for electromagnetic
(EM) tracking of instruments with respect to pre-acquired or real-time data. The
device is intended for use in Magnetic Resonance Imaging (MRI) and ultrasound
(US) environments.
CAUTION
• Federal (United States) law restricts this device to sale by or on the order of a physician.
• Before use, you should be trained in ultrasonography. For instructions on the use of your
WARNING
transducer, see your system's user guide.
• Prior to use inspect device for signs of damage, if damage is evident do not use.
• Prior to use ensure general purpose sensor is tracking properly.
• Active patient tracker is packaged non-sterile and is intended for single-patient use only.
• To avoid possible position distortion keep general purpose sensor away from metal.
• Ensure device is securely attached, failure to do so could result in inaccuracy.
• If device leakage occurs, fluid is non-cytotoxic and routine hospital clean-up protocol
should be followed.
• Device is MR safe.
MR SAFE
I. Attaching omniTRAX
• Ensure device is secure on patient prior to use.
WARNING
• MR image quality may be compromised if the anatomical region of interest is
NOTE
in close proximity of the device. Image artifact extends approximately 2mm
from the adhesive pads of the device. To optimize imaging parameters, it is
recommended to position the device away from anatomical region of interest,
but within the range of the MR scan.
1. Remove adhesive liners and position active patient tracker onto patient's skin.
2. Mark device location on patient's skin using active patient tracker marking locations.
Active Patient Tracker
Active Patient Tracker to Patient
™
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