Civco ULTRA-PRO II Referenzhandbuch Seite 7

Ultra-Pro II™ Needle Guidance System
BRACKET / NEEDLE GUIDE
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
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.
INDICATIONS FOR USE
Abdominal - Biopsy, Fine-Needle Aspiration, Regional Anesthesia Injections.
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Regional Anesthesia - Nerve Block, Musculoskeletal Injections.
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Small Parts - Biopsy, Fine-Needle Aspiration, Regional Anesthesia Injections.
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PATIENT POPULATION
General Purpose Guidance Systems are intended for use with appropriately sized transducer intended for use on adults
of all body habitus, including small or slight frame.
INTENDED USERS
General Purpose Guidance Systems 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 Bracket and Needle Guide use.
This may include, but is not limited to: Anesthesiologists, Interventional Radiologists, Nephrologists, Radiologists,
Sonographers and Surgeons.
PERFORMANCE CHARACTERISTICS
Ultra-Pro II™ Needle Guidance System provides accurate needle path with on-screen guidelines, supports wide
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range of gauge sizes, and incorporates quick-release feature for detachment of guide.
Cover serves as a viral barrier to protect patients, users, and equipment from cross-contamination.
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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 your
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system's user guide.
Review product labeling for sterile symbol. If sterile symbol appears on label, cover and guide are sterilized
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using ethylene oxide.
Sterile product is intended for single-use only.
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Do not use if integrity of packaging is violated.
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Do not use 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
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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 consisting of
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a 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 needle guides are recommended.
Bracket is packaged non-sterile and is reusable. To avoid possible patient contamination, ensure bracket is
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properly cleaned and 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 cover.
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For illustration purposes only, transducer and bracket may be shown without a transducer cover. Always place
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a cover over transducer and bracket to protect patients and users from cross-contamination.
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