Uterine Injector 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 Panpac Uterine Injectors are double lumen, slightly curved and designed for single use. It was developed to facilitate diagnostic procedures such as Laparoscopy, Minilaps, Salpingoplasties and Fertility Examinations. It is a sterile disposable product consisting of plastic tube, connector and other plastic components which meets the USP recommendation for class VI testing. PRODUCT NAME 4. Inject 5cc of air (UI-4.0) / 3cc of air (UI-2.0) via Pilot Balloon with syringe to Intrauterine Cuff (A). Also, DO NOT attempt to infuse additional air into cuff. Doing so may cause harm to the patient. 5. NEVER introduce fluid such as contrast media or water to inflate the Intrauterine Cuff (A). Such act will impair Intrauterine Cuff. 6. Do not reuse for avoiding user may be infected by the microorganism. 1. Sound the depth and direction of uterus prior to using INDICATIONS Panpac Uterine Injector is intended to be used during hysterosonography, hydrotubation, hysterosalpingogram, and salpingoplasties. 1. The safety and effectiveness of Panpac Uterine injectors have not been demonstrated in the setting of uterine bleeding. 2. DO NOT use this device when the sterile pouch has been punctured or damaged. 3. Test inflatable cuff before insertion for possible leakage. DO NOT use the device while the Cuff is malfunction. the Injector-4.0 or the Injector-2.0. Insert it along the proper axis to avoid uterine trauma. Snap firmly in place for cervical stop (E) to the tubing (F) before use. The default setting is that the cervical stop is locked on the tubing at the 6 Centimeter Marking but not firmly. Snap it back on at the appropriate sounding depth marking before use. Lubricate catheter tip before use. Check for necessity to dilate cervix before insertion to avoid tearing inflatable cuff. When using any liquid media, precisely follow manufacturer instruction. After insertion and inflation insure the cuff is properly inflated. (Squeeze pilot balloon and check its tautness.) A deflated cuff may cause injury and trauma to the uterus. Exactly follow a procedure to remove this device; INSPECT the device for intactness.

ADVERSE REACTIONS 1. Perforation of the uterine wall 2. Cramping 3. Infection uterus less 6cm, no needs to adjust cervical stop (E) but snap firmly in place. If exceeds, adjust cervical stop to appropriate marks and snap firmly in place. e.g., if the uterine depth measures 8cm, then slide and set Cervical Stop (E) at the 8cm mark. Note: The default value of centimeter depth marking for Cervical Stop is six. 3. If necessary, enlarge the uterine cervix to #13-14 hand size with proper existing surgical techniques. The inflatable cuff may tear if it is forced into a cervix too tight, leading to possibly...