Civco Verza Manual De Instrucciones página 4

English
TRACKING BRACKET
INDICATIONS FOR USE / INTENDED USE
The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image
data.
GUIDANCE SYSTEM
INDICATIONS FOR USE / INTENDED USE
The system provides guidance for precise instrument placement of common interventional devices by positioning the
device relative to the ultrasound transducer and the resulting image during a diagnostic or therapeutic procedure. This
guidance system is intended for use with pediatric and adult patients.
COVER
INDICATIONS FOR USE / INTENDED USE
Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover
allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-
operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate
material to the patient and healthcare worker during reuse of the transducer (both sterile and non-sterile covers). The
cover also provides a means for maintenance of a sterile field (sterile covers only). CIVCO Poly Ultrasound Transducer
Covers are furnished sterile & non-sterile; single use patient / procedure, disposable.
CAUTION
Federal (United States) law restricts this device to sale by or on the order of a physician.
WARNING
Verza Guidance System is designed and validated for use with transducer(s) listed on the cover of this
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instruction.
Tracking bracket is for use with CIVCO general purpose sensors only.
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General purpose sensor is for use with CIVCO accessories only.
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Before use, you should be trained in ultrasonography. For instructions on the use of your transducer, see
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your ultrasound system's user guide.
Prior to use, ensure general purpose sensor is tracking properly.
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To avoid possible position distortion, keep general purpose sensor away from metal.
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Disposable components are packaged sterile and are single-use only. Do not use if integrity of packaging is
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violated or if expiration date has passed.
Do not reuse, reprocess or resterilize single-use device. Reuse, reprocessing or resterilization may create a
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risk of contamination of the device, cause patient infection or cross-infection.
CIVCO's guidance systems are designed and validated as an integrated two-part system consisting of a
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custom reusable bracket and a disposable guide. Use of non-CIVCO guides on a CIVCO bracket or locating
feature may result in serious injury to the patient and/or user. To ensure safe and effective use in
compliance with system software guidelines, only CIVCO guides are recommended.
Bracket and general purpose sensor are packaged non-sterile and are reusable. To avoid possible patient
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contamination, ensure bracket and general purpose sensor are properly cleaned and sterilized before each
use.
Do not use if bracket or general purpose sensor appear damaged or do not fit properly.
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Do not use if locating feature is damaged or guide does not fit properly.
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Ensure gauge insert is in closed position prior to beginning procedure.
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Use only water-soluble agents or gels. Petroleum or mineral oil based materials may harm cover.
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For illustration purposes only, components may be shown without a cover. Always place a cover over
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transducer, general purpose sensor and bracket to protect patients and users from cross-contamination.
NEEDLE PATH VERIFICATION
Before using component for first time, perform needle path verification to verify system and Verza guide
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relationships, as described in ultrasound system user guide.
Before each use, verify guidance system angles (5) correspond with system software.
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NOTE: Use appropriate needle length to reach target area. Verza guide channel measures 3.4cm (1.34in).
with Verza™ Guidance System
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Tracking Bracket