Uterine Manipulator /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 Manipulator is a simple, safe and effective device for Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty. It also helps the sealing of the cervical os while providing a fluid or air to the cuff. 4. Do not reuse for avoiding user may be infected by the microorganism 5. Federal law requires that these devices be ordered by a physician. PRECAUTIONS PRODUCT NAME THE MANIPULATOR -4.5 1. Test inflatable cuff before insertion for possible leakage. 2. Lubricate catheter tip before use. 3. Check for necessity to dilate cervix before insertion to avoid tearing inflatable cuff. 4. When using any liquid media, be sure to follow manufacturer instruction. Use of the Panpac Manipulator is indicated in 5. After insertion and inflation insure the cuff is properly inflated. (Squeeze pilot balloon and Diagnostic Laparoscopy, Minilaparotomy, Fertility check its tautness.) Exams, and Salpingoplastic procedures where manipulation of the uterus is required. 6. A deflated cuff may cause injury and trauma to the uterus. WARNINGS 1. Ensure the catheter is secured to the handle. It’s possible that the handle may be loosened during transportation. Snap it back on at the. 6cm mark before use. 2. Inflate the cuff before manipulation is essential to avoid trauma to the uterus. 7. Inspect the device for its integrity after use to ensure no parts are left inside. ADVERSE REACTIONS 1. Perforation of the uterine wall 2. Cramping 3. Insert Manipulator along the proper axis to avoid 3. Infection uterine trauma.

10. Inflate the cuff slowly with 3 to 10 cc of air until the cervical stop being pulled up tightly against the cervix. When detach the syringe, hold the plunger to prevent reflux of air back into the syringe. 11. Pull gently on the manipulator to be sure cuff inflation is adequate. Excessive cuff inflation may cause utero-tubal spasm and physiologic closure of patent tubes. 12. To insure the cuff has not ruptured during procedure, check the tautness of the pilot balloon. A soft balloon indicates a ruptured or leaking cuff. 13. To remove the manipulator, insert a syringe in the valve and deflate...