Indications For Use; Patient Population - Civco OMNITRAX Bedienungsanleitung

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omniTRAX™ ACTIVE PATIENT TRACKER
INTENDED USE
The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to
image data.
Device is not intended for use in MR scanning.

INDICATIONS FOR USE

Abdominal - Image guided minimally invasive puncture procedures.
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Small Parts - Image guided minimally invasive puncture procedures.
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Transrectal - Image guided minimally invasive puncture procedures.
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PATIENT POPULATION

omniTRAX™ Active Patient Tracker is intended for use on adults of all body habitus, including small or slight frame.
INTENDED USERS
omniTRAX™ Active Patient Tracker should be used by clinicians medically trained in the use and interpretation of
ultrasound for interventions. There are no other unique skills or user abilities required for device use. This may
include, but is not limited to: Interventional Radiologists, Radiologists, Sonographers and Surgeons.
PERFORMANCE CHARACTERISTICS
The omniTRAX™ Active Patient Tracker provides clinicians automatic image registration of fused images for
uninterrupted navigation when using real-time ultrasound with previously acquired CT volume data sets.
NOTE: For a summary of clinical benefits for this product, visit www.CIVCO.com.
CAUTION
Federal (United States) law restricts this device to sale by or on the order of a physician.
WARNING
Before use, you should be trained in ultrasonography. For instructions on the use of your transducer, see
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your system's user guide.
Prior to use, refer to your system's user guide for use of general purpose sensor.
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Prior to use, inspect device for signs of damage, if damage is evident do not use.
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Prior to use, ensure general purpose sensor is tracking properly.
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Active patient tracker is packaged non-sterile and is intended for single-patient use only.
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To avoid possible position distortion, keep general purpose sensor away from metal.
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Ensure device is securely attached, failure to do so could result in inaccuracy.
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Ensure device is secure on patient prior to use.
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Ensure general purpose sensor is securely attached to the active patient tracker.
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If the product malfunctions during use or is no longer able to achieve its intended use, stop using the
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product and call CIVCO.
Report serious incidents related to the product to CIVCO and the competent authority in your Member
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State or appropriate regulatory authorities.
NOTE: Product is not made with natural rubber latex.
omniTRAX™ Active Patient Tracker
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