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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
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while 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.
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The 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
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your 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
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sterilized 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
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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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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
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place a cover over transducer and bracket to protect patients and users from cross-contamination.
Ensure no air bubbles are present prior to use. Air left between cover and transducer lens may cause poor
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image quality.
If the product malfunctions during use or is no longer able to achieve its intended use, stop using the
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product and call CIVCO.
Report serious incidents related to the product to CIVCO and the competent authority in your Member
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State or appropriate regulatory authorities.
NOTE: Product is not made with natural rubber latex.
with Verza™ Guidance System
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Tracking Bracket
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