Indications For Use; Performance Characteristics - Civco Verza Manual De Instrucciones

Tracking Bracket
with Verza™ Guidance System
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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Surgical - Image guided minimally invasive puncture procedures.
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Therapeutic Injections - Image guided joint injections.
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PATIENT POPULATION
Tracking Brackets are intended for use on adults of all body habitus, including small or slight frame.
INTENDED USERS
Tracking Brackets 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

Tracking Brackets are designed to hold EMT sensors in close proximity to the ultrasound transducer while
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connected to the ultrasound system.
The Verza Needle Guidance System's innovative design reduces blind zone and unguided needle length while
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providing high stability for improved accuracy. Verza offers maximum versatility with a five-angle approach for
improved anatomical access while also featuring an expanded gauge range, accommodating 14 different sizes
of interventional instruments. Verza features easy-to-read gauge sizes, angle indicator and repeatable bolt action
quick-release for secure instrument detachment.
The Verza Bracket design includes a simplified multi-angle design free of lock pins and removable parts. The
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bracket also offers a low-profile fit, sleek design for ease of cleaning, and secure user-friendly closure door for
ease of application and removal.
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
Verza Guidance System is designed and validated for use with transducer(s) listed on the cover of this
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instruction.
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.
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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Prior to use, ensure general purpose sensor is tracking properly.
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Prior to use, refer to your system's user guide for use of general purpose sensor.
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To avoid possible position distortion, keep general purpose sensor away from metal.
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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 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 is packaged non-sterile and is reusable. To avoid possible patient contamination, ensure bracket is
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properly cleaned, sterilized or disinfected before each use.
Do not use if bracket is damaged or does 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, 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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