Civco ULTRA-PRO II Mode D'emploi page 3

Ultra-Pro II™ Needle Guidance System
BRACKET / NEEDLE GUIDE
INDICATIONS FOR USE
The guidance system is intended for directing instruments such as catheters, electrodes and needles
into a targeted anatomical location of a patient relative to the imaging instrument for percutaneous
procedures. Prior to use healthcare workers should be trained in ultrasonography.
INTENDED USE
The bracket and disposable guide provide physicians with a tool for performing needle-guided (or
catheter) procedures with the use of diagnostic ultrasound transducers.
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
Before use, you should be trained in ultrasonography. For instructions on the use of your
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transducer, see your system's user guide.
Disposable components are packaged sterile and are single-use only. Do not use if integrity of
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packaging is violated or if expiration date has passed.
Do not reuse, reprocess or resterilize single-use device. Reuse, reprocessing or resterilization
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may create a risk of contamination of the device, cause patient infection or cross-infection.
CIVCO's needle guidance systems are designed and validated as an integrated two-part system
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consisting of a custom reusable bracket and a disposable needle guide. Use of non-CIVCO
guides on a CIVCO bracket 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 needle guides
are recommended.
Bracket is packaged non-sterile and is reusable. To avoid possible patient contamination,
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ensure bracket is properly cleaned, sterilized or disinfected before each use.
Do not use if bracket is damaged or does not fit properly.
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Use only water-soluble agents or gels. Petroleum or mineral oil based materials may harm
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cover.
For illustration purposes only, transducer and bracket may be shown without a transducer
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cover. Always place a cover over transducer 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
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biopsy guide relationships, as described in system manual.
NOTE: Use appropriate needle length to reach target area.
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