GYN 48-4 08/2014-E Intra-uterine BIGATTI Shaver (IBS®) IBS®, an alternative approach to operative hysteroscopy At present, conventional resection can be considered the gold standard procedure for major hysteroscopic operations. Despite well-recognized advantages of resection, several problems, such as fluid overload, uterine perforation due to unipolar or bipolar current, lack of visualization resulting in a time-consuming procedure, and a long learning curve, remain still unsolved. We have made, in cooperation with KARL STORZ, a new shaving system that, when introduced through a straight operative channel of a panoramic angled telescope, allows performance of all kinds of major operative procedures such as polypectomy or myomectomy, (G0): The Intra-uterine BIGATTI Shaver (IBS®). The IBS® consists of an angulated 6° telescope with a sheath and an extra working channel wherein a rigid shaving system is introduced. The inflow of the sheath is connected to a peristaltic pump in order to maintain distension and visualization inside the uterine cavity. The outflow of the sheath is not connected and only used for passive outflow. The outer sheath diameter is 24 Fr. (8 mm). The rigid shaving system consists of two hollow reusable metal tubes fitting to each other. The inner tube oscillates within the outer tube and is connected to a handpiece (DRILLCUT-X® II), a motor unit (UNIDRIVE® S III) and to a roller pump (ENDOMAT® LC) controlled by one foot pedal. The foot pedal activates the movements of the shaver tip and the roller pump’s aspiration at the same time, in order to maintain a continuous suction power of solution and tissue axial through the hollow blade during the procedure. G. Bigatti, M.D. U.O. di Ostetricia Milan, Italy 2 3 Benefits • Reduced dilation of the cervix • For use in physiological saline solution • Reduced risk of fluid overload when using saline solution • Resection without high-frequency current • Perfect visualization thanks to direct extraction of tissue chips during resection Special Features HOPKINS® Wide-Angle Straight Forward Telescope 6° • Brilliant image quality due to integrated rod lens system • Integrated working and inflow channel Operating Sheath • Less dilation of the cervix due to thin outer diameter (24 Fr.) • Continuous flow is achieved through the passive outflow DRILLCUT-X® II Shaver Handpiece GYN, for use with UNIDRIVE® S III • Adjustable ergonomic handle for simple handling • Powerful oscillating rotations for fast resection • Integrated suction channel for immediate removal of tissue chips out of the uterine cavity Shaver Blades • Two different blades for individual use • Direct extraction of resected tissue through suction channel • Optimal cutting performance UNIDRIVE® S III Motor Unit, compatible with: • IBS® • ROTOCUT G1 / G2 Morcellators • SUPERCUT SAWALHE II Morcellator ENDOMAT® LC • Necessary roller pump for powerful suction HAMOU® ENDOMAT® • Powerful roller pump for both irrigation and suction • Constant intrauterine pressure • Continuous regulated irrigation 4 5 IBS® System Components Optional: 26092 AMA HOPKINS® Wide Angle Straight Forward Telescope 6°, with parallel eyepiece, length 20 cm, autoclavable, fiber optic light transmission incorporated, with working channel, with LUER-Lock connector for inflow, color code: yellow 26093 CD Operating Sheath, 24 Fr., rotating, for continuous irrigation and passive outflow, with LUER-Lock stopcock, color code: white 26093 OC Hollow Obturator, color code: white 26 7020 50 DRILLCUT-X® II Shaver Handpiece GYN, for use with UNIDRIVE® S III 40 7120 90 Handle, adjustable, for use with DRILLCUT-X® II 26 7020 50 26208 SA Shaver Blade GYN, straight, sterilizable, concave cutting edge, double serrated, oval cutting window, diameter 4 mm, length 32 cm, for use with DRILLCUT-X® II Handpiece 26 7020 50, color code: blue-green 26208 SB Shaver Blade GYN, straight, sterilizable, double serrated cutting edge, rectangular cutting window, diameter 4 mm, length 32 cm, for use with DRILLCUT-X® II Handpiece 26 7020 50, color code: blue-yellow Optional: Bipolar coagulation electrode with high frequency cord for use with existing HF unit 26208 SZCoagulation Electrode, bipolar, for use with Intrauterine Bigatti Shaver (IBS) 26176 LEBipolar High Frequency Cord, length 300 cm, for AUTOCON® II 400 SCB system (111, 113, 115, 122, 125), AUTOCON® II 200, AUTOCON® II 80, KARL STORZ Coagulator 26021 B/C/D, 860021 B/C/D, 27810 B/C/D, 28810 B/C/D, AUTOCON® series (50, 200, 350), Erbe-Coagulator, T and ICC series Required Units Shaver control unit 26 7010 01-1UNIDRIVE® S III SCB, GYN Set, motor system, with KARL STORZ-SCB, power supply 100 –120/230 – 240 VAC, 50/60 Hz, including: Mains Cord One-Pedal Footswitch, two-stage, with proportional function and pump switch function SCB Connecting Cable, length 100 cm 6 7 Required Units 20 3303 02-1ENDOMAT® LC SCB, power supply 100 – 240 VAC, 50/60 Hz, including: Silicone Tubing Set, for suction, sterilizable SCB Connecting Cable, length 100 cm Control Cable, UNIDRIVE® S III – KARL STORZ pump systems Suction pump for suction of tissue concrements 031247-10 Single-use Tubing Set (suction), sterile, package of 10 030970-10 Single-use tissue trap filter with adaptor, non-sterile, package of 10, for use with VACUsafe suction bags and other suction bottle systems Recommended Irrigation Pump 26 331101-1 ENDOMAT® n. HAMOU® SCB, Set, power supply 100 – 240 VAC, 50/60 Hz including: SCB Connecting Cable, 100 cm Basic Cassette Tubing Sets, for single use VACUsafe Promotion Pack Suction, 2 l Irrigation pump for safe pressure controlled dilation of the operating field 031517-10 Single-use cassette tubing set with two puncture needles, sterile, package of 10, for use with KARL STORZ HAMOU® ENDOMAT® 26 3311 20 (hysteroscopy) Notes 8 9 Notes Notes 10 11 Notes It is recommended to check the suitability of the product for the intended procedure prior to use. Consent to receive electronic information EW GYN 48-E 96122041 GYN 48-4 08/2014/EW-E q Yes, I agree to receive future information by email at the following address: Email Name Department / Practice Street address ZIP, Town Signature I agree to my data being stored at KARL STORZ for this purpose. I can withdraw my consent at any time and without giving reasons by emailing KARL STORZ at [email protected]. KARL STORZ will not make these data available to third parties. KARL STORZ Endoscopy-America, Inc. 2151 East Grand Avenue El Segundo, CA 90245-5017, USA Phone: +1 424 218-8100 Phone toll free: 800 421-0837 (US only) Fax: +1 424 218-8525 Fax toll free: 800 321-1304 (US only) E-Mail: [email protected] 96122041 GYN 48-4 08/2014/EW-E KARL STORZ GmbH & Co. KG Mittelstraße 8, 78532 Tuttlingen, Germany Postbox 230, 78503 Tuttlingen, Germany Phone: +49 (0)7461 708-0 Fax: +49 (0)7461 708-105 E-Mail: [email protected] www.karlstorz.com
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