Civco Medical Instruments Endocavity Needle Guide| 10041822

Civco Needle guide consists of single-piece system, allowing ease-of-use and removal from probe while providing easy clean-up between procedure.

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 intraoperative 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 ovaries.
• Transrectal - Diagnostic imaging and invasive puncture and drainage procedures of the prostate.
• Surgical - Diagnostic imaging and invasive puncture procedures of the prostate.

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 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.

NEEDLE PATH VERIFICATION

• Before using component for first time, perform needle path verification to verify system and biopsy guide relationships, as described in system user guide.
• See transducer user guide for proper procedure.
• Use care when inserting needle to avoid bending.

NOTE: Use appropriate needle length to reach target area.