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Disposable Endocavity Needle Guide
NEEDLE GUIDE
INTENDED USE
This device provides physicians with a tool for performing needle/instrument guided procedures with the use of the
diagnostic ultrasound endocavity transducer.
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 Latex Transducer Covers
are furnished sterile & non-sterile; single use patient / procedure, disposable.
INDICATIONS FOR USE
Transvaginal - Diagnostic imaging and invasive puncture, and drainage procedures of the pelvis, uterus and
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ovaries.
Transrectal - Diagnostic imaging and invasive puncture and drainage procedures of the prostate.
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Surgical - Diagnostic imaging and invasive puncture procedures of the prostate.
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PATIENT POPULATION
Endocavity Guidance Systems are for use with endocavity (transvaginal or transrectal) transducers intended for use
on adults of all body habitus, including small or slight frame.
INTENDED USERS
Endocavity 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 Endocavity Guide use. This
may include, but is not limited to: Maternal Fetal physicians, OB/GYN, Radiologists, Sonographers, Surgeons and
Urologists.
PERFORMANCE CHARACTERISTICS
Endocavity Guidance Systems are designed to correspond with on-screen system guidelines, directing
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instruments for accurate placement. Contoured design provides a low-profile, secure fit to the transducer,
maximizing patient comfort.
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
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your system's user guide.
Transducer covers containing natural rubber latex may cause allergic reactions. In the USA, refer to FDA
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Medical Alert MDA91-1.
Use of a needle guide on an endocavity transducer may increase the risk of vaginal or rectal abrasion.
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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.
Use only water-soluble agents or gels. Petroleum or mineral oil based materials may harm cover.
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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.
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 use if needle guide is damaged or does not fit properly.
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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.
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