Panpac Medical Corporation 6F-2, No. 202, Sec. 3, Ta-Tong Road, Shi-Chih District, New Taipei City, Taiwan. TEL : 886-2-86472242 FAX : 886-2-86472770 LATEX FREE HSG catheter sets can be used for sonohysterography and hysterosalpingography procedures that greatly enhance the analysis of uterine pathology. Using HSG balloon catheters, the procedures are simple and non-traumatic for your patients. A placement sheath eliminates the need for a tenaculum. HSG catheters are designed for single patient use only. CAUTION: Federal law requires that these devices be ordered by a physician. Do not reuse for avoiding user may be infected by the microorganism. INDICATIONS: PANPAC HSG Catheter Sets are indicated to evaluate the causes of abnormal uterine bleeding, menstrual disorders, recurring pregnancy loss, or unexplained infertility. They can also be used to assess uterine pathology and patients on tamoxifan therapy. HSG type catheter sets are used to infuse a fluid (either a contrast media or a sterile saline) into the uterine cavity while blocking the external cervical OS to retain the fluid in the uterus during the procedure. gynecologic malignancies, or if the patient is allergic to the contrast media. This device should not be used for intrafallopian procedures. PROCEDURES: Remove the HSG set from the sterile pouch and remove the balloon protective sleeve from the distal end of the catheter. Using the attached syringe, inflate the silicone balloon by opening the stopcock attached to the syringe luer. Then allow the silicone balloon to completely deflate. This procedure ensures the integrity of the HSG balloon. Attach the media source to the open luer and allow the contrast media to flow through the catheter removing air and clearing the media channel. DIRECTIONS FOR USE: With the guiding sheath, position the HSG catheter so that the tip of the catheter is at the entrance of the cervix external OS. Gently push the HSG catheter, with balloon, through the cervical canal and into the uterine cavity. Inflate the balloon within the uterine cavity and close the balloon stopcock to prevent the balloon from deflating. Carefully withdraw the catheter until the balloon is resting against the internal OS. Now inject the contrast media into the uterus and proceed with the examination. In cases where the access to the uterus is difficult, the balloon may be inflated within the cervical canal. CONTRAINDICATIONS: HSG procedures are contraindicated in pregnancies, suspected pregnancies, active pelvic infections, or recent pelvic infections, severe uterine bleeding, DO NOT REUSE BATCH CODE