Civco eTRAX, Reference Manual

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English eTRAX™ Needle System
2
eTRAX SYSTEM
INDICATIONS FOR USE / INTENDED USE
The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image
data.
NEEDLE SENSOR COVER
INDICATIONS FOR USE / INTENDED USE
The cover allows use of a sensor for body surface, endocavity and intra-operative applications while helping to prevent
transfer of microorganisms, body fluids and particulate material to the patient and healthcare worker.
CAUTION
Federal (United States) law restricts this device to sale by or on the order of a physician.
PRIOR TO USE
Refer to your ultrasound system's user guide for use of needle sensor.
WARNING
n
Prior to use inspect device for signs of damage, if damage is evident do not use.
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Prior to use ensure needle sensor is tracking properly.
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Disposable components are packaged sterile and are single-use only. Do not use if integrity of packaging is
violated or if expiration date has passed.
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Do not reuse, reprocess or resterilize single-use device. Reuse, reprocessing or resterilization may create a
risk of contamination of the device, cause patient infection or cross-infection.
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Needle sensor is packaged non-sterile and is reusable. To avoid possible patient contamination, ensure
needle sensor is properly cleaned and disinfected before each use.
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Ensure device is securely attached, failure to do so could result in inaccuracy.
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Ensure needle sensor gauge size matches eTRAX needle gauge size. Failure to do so could result in
inaccuracy.
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Needle sensor system is for use with CIVCO disposable needles and covers only.
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Device must be removed prior to patient defibrillation.
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To avoid possible position distortion keep needle sensor away from metal.
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eTRAX sheath is conductive and does not provide insulation. Use of ablation electrodes without an insulated
cannula may result in serious injury to the patient and/or user. To ensure safe and effective use, follow the
manufacturer's directions and recommended practices.
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Only stylet portion of eTRAX Needle System is a tracked instrument. After stylet is removed from sheath, the
sheath should remain in pre-positioned location. If sheath is displaced at any time, reposition using tracked
stylet.
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For illustration purposes only, needle sensor may be shown without a cover. Always place a cover over
needle sensor to protect patients and users from cross-contamination.
SENSOR GAUGE SIZE NEEDLE GAUGE SIZE ACCEPTED INSTRUMENTS
12GA 12GA ≤ 14GA
14GA 14GA ≤ 16GA
16GA 16GA ≤ 18GA
18GA 18GA ≤ 20GA