Bellota Sonohysterography Catheter with Cervical Cone Panpac Medical Corporation 6F-2, No. 202, Sec. 3, Ta-Tong Road, Shi-Chih District, New Taipei City, UIC 5FA: Total Length 296mm /Sleeve Length 125mm UIC 5FAX: Total Length 296mm / Sleeve Length 155mm The catheter is to be used for sonohysterography procedures that aid in the analysis of uterine pathology. A placement sheath eliminates the need for a tenaculum. This catheter is designed for single patient use. PACKAGING: 25 sterile catheters per box Federal law restricts this device to sale by or on the order of a physician. Do not reuse for avoiding user may be infected by the microorganism. The Bellota Sonohysterography Catheter with Cervical Cone (Model: UIC 5FA) is used to access the uterine cavity for saline infusion Sonohysterography procedure ● CONTRAINDICATIONS The catheter type procedures are contraindicated in pregnancies, suspected pregnancies, active pelvic infections, or recent pelvic infections, severe uterine bleeding, gynecologic malignancies. This device should not be used for intrafallopian or intratubal procedure or for in-vitro fertilization. Remove the catheter from the sterile pouch. Attach the saline to the open luer and allow the saline to flow through the catheter removing air and flushing the saline channel. Adjust the protective sheath so that just 1/2 to 1 cm of the catheter protrudes beyond the sheath. Expose the cervix using a speculum and clean it with an antiseptic solution. The single-lumen tube is featured with centimeter depth markings along its distal segment from 6-10cm to set the depth of insertion. It is helpful to place the catheter properly. Carefully advance the 5f catheter through the cervical canal and past the internal cervical OS, so that the catheter is within the uterine cavity while the catheter advanced and placing the acorn to avoid any fluid reflux. Attach saline solution to open syringe and introduce through catheter slowly. Remove the speculum and insert the transvaginal transducer into its proper position adjacent to the catheter. Now activate the ultrasound system and inject saline as required by the procedure. Usually, 3cc to 20cc is sufficient saline for a proper diagnosis. Perform Sonohysterography in the usual way. Endometrial distention usually can be maintained throughout the procedure. If uterine distention is not visualized with ultrasound while saline is injected into the catheter or leaking is observed from the vagina, verify that the catheter is positioned correctly in the uterine cavity before continuing. Upon completion of Sonohysterography, remove the catheter carefully from uterine cavity. STORAGE: Store at room temperature. DO NOT REUSE BATCH CODE MANUFACTURER STERILE-ETHYLENE OXIDE