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Refer to separate insert for Symbol Glossary.
NEEDLE GUIDE
INTENDED USE
Device is intended to be used for instrument placement to access anatomical structures under transrectal ultrasound
guidance.
COVER
INTENDED USE
Protective cover or sheath placed over an ultrasound transducer / probe / scanhead instruments. The cover is used
with the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-operative
diagnostic, interventional, or therapeutic ultrasound. The cover also helps to prevent transfer of microorganisms,
body fluids, and 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).
INDICATIONS FOR USE
Prostate - Biopsy and minimally invasive puncture.
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Surgical (Prostate)- Biopsy and minimally invasive puncture.
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PATIENT POPULATION
TP Pivot Pro is intended for use on adult males of all body habitus, including small or slight frame.
INTENDED USERS
Needle Guides should be used by clinicians medically qualified in the proper use of transperineal ultrasound for
guiding needle placement. User groups may include, but are not limited to: Urologist, Urological Surgeon,
Urological Nurse, Radiation Oncologist, Physician Assistant and Nurse Practitioner.
PERFORMANCE CHARACTERISTICS
TP Pivot Pro needle guide provides a secure fit on most transrectal ultrasound transducers with its adjustable
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locking knob which ensures a stable position allowing users to perform guided, free-handed transperineal
prostate biopsies through an initial access needle. TP Pivot Pro offers 5 adjustable heights and varying
angles to improve access to different zones throughout the prostate gland. The needle path angle feature
decreases the need to angle the probe, thereby reducing probability of image dropout when assessing
posterior gland.
Cover serves as a viral barrier to protect patients, users, and equipment from cross-contamination.
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INTENDED CLINICAL BENEFITS
Freehand transperineal prostate biopsy approach provides detection of clinically significant disease and
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greater sampling of the anterior prostate.
NOTE: For a summary of clinical claims 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
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your system's user guide.
Cover and guide are sterilized using ethylene oxide.
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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.
Do not use if needle guide 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 may be shown without a transducer cover. Always place a cover
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over transducer to protect patients and user 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.
TP Pivot Pro™ Needle Guide
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