Laparoscopic Obesity Surgery

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LAP 55-5 07/2014-E Laparoscopic Obesity Surgery CADIERE 5/10 Instrument Set

2 3 Laparoscopic Obesity Surgery CADIERE 5/10 Instrument Set Introduction Obesity has become an epidemic problem in developed countries. Obesity is associated with co-morbidities which are responsible for over 2.5 million deaths per year worldwide. The loss of life expectancy due to obesity is significant. Obesity is rapidly becoming one of the major medical problems of the developed world. Currently surgery is the only long term effective treatment for morbid obesity. Laparoscopic bariatric surgery is associated with less pain, shorter hospital stay and quicker return to normal activity as compared to open techniques. The laparoscopic approach is less invasive which in the physiologically fragile obese patient induces lower stress, cardiopulmonary burden, blood loss and hence a better outcome. Laparoscopy allows faster patient mobilization, which translates to a reduced risk of pulmonary embolism and atelectasis. Laparoscopic obesity surgery is also associated with a lower incidence of wound related problems such as incisional hernia and abscesses. Laparoscopy also induces fewer adhesions resulting in a reduced incidence of bowel obstruction. The laparoscopic access improves the accuracy of the surgical task due to a better view, a good ergonomic position and following the achievement of a learning curve, an improved suturing accuracy as compared to open surgery. The instruments need to be designed in a way that allow the surgeon to work without constraints in an ergonomical and fatigue-free position. Furthermore the instruments in the set have been marked with 5/10 cm measurement marks on the shaft which enable precise intra-operative measurements. As a rule, the surgeon operates two-handed in the most ergonomic position, and never actually holds the camera himself. With his dominating hand the surgeon dissects, cuts, coagulates, suctions and sutures. The non-dominating hand grasps tissue for suturing or dissecting and will usually manipulate the grasping forceps. G. B. Cadière

General Principles of Laparoscopic Obesity Surgery The quality of a surgical procedure depends largely on the surgeon s skills and know-how, as well as on the quality and variety of the instruments and of the image guiding the surgeon s actions. Documentation of the OR procedure will be of high importance. The technique of obesity surgery relies on simple but essential principles and actions: Patient and surgeon s position. Placement of trocars, optics and laparoscopic instruments. Knowledge about the specific laparoscopic anatomy. Ability to suture and tie knots intra- and extracorporeally. Position of the Patient, Surgeons and Trocars The first rule in laparoscopy concerns the position of instruments, surgeon s head, patient s operative field and video screens. Ideally, the latter three should be separate points on one axis. The second rule in laparoscopy concerns the trocar placement: there is a distinction between operative or working and assisting trocars. The operative trocars, manipulated by the surgeon, should be at a right angle with the optical system at the bisector of this angle. The ancillary tools, harboured by the assisting trocars, are placed outside the triangle outline by the operating and optical trocars.

CADIERE 5/10 Instruments 4 5

CADIERE Requirements on Laparoscopic Instruments Trocars Should be simple to use and as slimline as possible. Should be airtight and allow good sliding of the instruments. Should be easy to introduce into the abdomen. A reducer is necessary for the use of a 5 mm instrument through a 13 mm trocar, in order to maintain the pneumoperitoneum. 30160 AP Trocar, with pyramidal tip, insufflation stopcock, automatic valve, size 6 mm, working length 10.5 cm, color code: black, including: Cannula, without valve Trocar only Automatic Valve 30103 AP Same, size 11 mm, color code: green 30107 AP Same, size 13 mm, working length 11.5 cm, color code: black 30141 HB Reducer, 13/5 mm and 13.5/5 mm

6 7 Optical System This system must allow a precise vision at a distance from the operative site without loss of focus or light intensity. This results in less camera motions and in a wider optical field. A 30 telescope allows inspection from different angles through one trocar site. 26003 BA HOPKINS Forward-Oblique Telescope 30, enlarged view, diameter 10 mm, length 31 cm, autoclavable, fiber optic light transmission incorporated. color code: red

Instruments for the Dominating Hand Unipolar Hook The unipolar hook with 5/10 cm marks on the shaft allows precise measurements. The hook is designed for dissection, for isolating structures and for transsection-coagulation. The distal end is formed as a semi-circle: the outer curvature is thick for safe dissection; the inner one is sharp allowing prompt dissection with minimal side coagulation. The grip is hatched for better grasp. The length of the hook allows ergonomic conditions. 26775 C CADIERE Coagulating and Dissecting Electrode, L-shaped, with cm-marking, distal tip tapered, with connector pin for unipolar coagulation, size 5 mm, length 36 cm Needle Holder Must be strong and stable, in order to hold the needle tightly. The handle must be along the same axis in order to allow pronation supination. The tip must be curved in order to facilitate knot tying. 26173 CN CADIERE Needle Holder, with tungsten carbide insert, straight handle, with ratchet and large Handle Attachment, size 5 mm, length 33 cm

8 9 Scissors The scissors marked with 5/10 cm measurement marks on the shaft enables precise measurements when required. The rotating axis allows abduction-free pronation and supination. 34351 MSC CLICKLINE METZENBAUM Scissors, rotating, insulated, with connector pin for unipolar coagulation, double action jaws, curved, length of jaws 12 mm, size 5 mm, length 36 cm including: Plastic Handle, without ratchet Metal Outer Sheath, insulated, with cm-marking Scissors Insert Suction Device Allows minute and accurate motions which are helpful for dissecting. The tube cross section and the side holes are designed so as to minimize loss of pneumoperitoneum. 37360 LH Suction and Irrigation Tube, with lateral holes, size 5 mm, length 36 cm, for use with suction and irrigation handles 031135-10 Adaptor, for single use, sterile, with LUER-Lock connector and tube olive for suction and irrigation, package of 10, for use with Suction and Irrigation Handle 38112 C 38112 C CADIERE Suction and Irrigation Handle, for suction and irrigation, autoclavable, for use with 3 mm, 5 mm and 10 mm irrigation tubes with thread on the instrument side, LAP Tubing Sets 031118-10 or 031119-10 for irrigation and Tubing Set 031136-10 for suction as well as tubes with a LUER adaptor 031118-10 LAP Tubing Set, for irrigation, for single use, sterile, package of 10 031119-10 Tubing Set, for irrigation, sterile, for single use, with two puncture cannulas, package of 10 031136-10 Adaptor and Suction Tube, for single use, sterile, package of 10, with LUER-Lock connector and tube olive, for use with Suction and Irrigation Handle 38112 C

Grasping Forceps in the Non-Dominating Hand The grasper marked with 5/10 cm measurement marks on the shaft enables precise measurements when required. The grasper is fenestrated, hence atraumatic in nature. The grasper s jaws are both short and strong enough in order to hold suture and needle in a stable fashion. One end allows for measurement in a precise way. The 110 angle facilitates good ergonomics of the nondominating hand. In order to avoid interference with the optical system the handles are kept short and the window is kept as small as needed for the surgeon s tasks. 33351 ONC CLICKLINE Grasping Forceps, rotating, with connector pin for unipolar coagulation, single action jaws, atraumatic, fenestrated, size 5 mm, length 36 cm including: Plastic Handle, without ratchet Metal Outer Sheath, insulated, with cm-marking Forceps Insert

10 11 Grasping Forceps for the Assistant The grasper has measurement marks 5/10 cm on the shaft. It should serve for retraction; therefore it needs to be solid. The grasper is fenestrated, hence atraumatic in nature. The reticulating axis allows for pronation-supination without the need for arm abduction. 33362 ONC CLICKLINE Grasping Forceps, rotating, dismantling, without connector pin for unipolar coagulation, with LUER-Lock irrigation connector for cleaning, single action jaws, with especially fine atraumatic serration, fenestrated, size 5 mm, length 36 cm including: Metal Handle, with MANHES style ratchet Metal Outer Sheath, insulated, with cm-marking Forceps Insert

IMAGE 1 HUB HD FULL HD Camera Control Unit Special Features: Maximum resolution and the consistent use of the 16:9 aspect ratio guarantee FULL HD (High Definition). Endoscopic camera systems have to be equipped with three CCD chips that support the 16:9 input format, as well as capturing images with a resolution of 1920 x 1080 pixels. The benefits of FULL HD (High Definition) for medical applications are: Up to 6 times higher input resolution of the camera delivers more detail and depth of field. Using 16:9 format during image acquisition enlarges the field of view. The 16:9 format of the widescreen monitor supports ergonomic viewing. The brilliant color rendition enables optimal diagnosis. Progressive scan technology provides a steady, flicker-free display and helps eliminate eyestrain and fatigue 22 201011U102 IMAGE 1 HUB HD Camera Control Unit SCB, with SDI Module for use with IMAGE 1 FULL HD and IMAGE 1 standard one- and threechip camera heads, max. resolution 1920 x 1080 pixels, with integrated SDI (Serial Digital Interface) module, KARL STORZ-SCB and integrated digital Image Processing Module, color systems PAL/NTSC, power supply 100 240 VAC, 50/60 Hz including: Mains Cord BNC Video Cable S-Video (Y/C) Connecting Cable Special RGBS Connecting Cable 2x Connecting Cables, for controlling peripheral units DVI-D Connecting Cable SCB Connecting Cable Keyboard, with US English character set Specifications: Signal-to-noise ratio AGC Video output Input IMAGE 1 HUB HD, three-chip camera systems M 60 db Microprocessorcontrolled - FULL HD signal to DVI-D socket (2x) - SDI signal to BNC socket (2x) - RGBS signal to D-Sub socket - S-Video signal to 4-pin Mini-DIN socket (2x) - Composite signal to BNC socket Keyboard for title generator, 5-pin DIN socket Control output/input Dimensions w x h x d (mm) Weight (kg) Power supply Certified to: - KARL STORZ-SCB to 6-pin Mini-DIN socket (2x) - 3.5 mm stereo jack plug (ACC 1, ACC 2), - Serial port at RJ-1 305 x 89 x 335 3.35 100-240 VAC, 50/60 Hz IEC 601-1, 601-2-18, CSA 22.2 No. 601, UL 2601-1 and CE acc. to MDD, protection class 1/CF defibrillation-safe SDI Serial Digital Interface: optimized for medical display on flat screens, routing with OR1 and digital recording with AIDA-DVD-M

12 13 IMAGE 1 HD FULL HD Camera Head 22 2200 55-3 50 Hz 60 Hz IMAGE 1H3-Z, Three-Chip FULL HD Camera Head 22 2200 55-3 max. resolution 1920 x 1080 pixels, progressive scan, soakable, gas and plasma- sterilizable, with integrated Parfocal Zoom Lens, focal length f = 15 31 mm (2x), 2 freely programmable camera head buttons, for use with color systems PAL/NTSC Specifications: Image sensor Pixel output signal H x V Dimensions (w x h x d) Weight Min. sensitivity Lens Grip mechanism Cable Cable length 3 x 1/3" CCD chip 1920 x 1080 39 x 49 x 114 mm 270 g F 1.4/1.17 Lux Integrated Parfocal Zoom Lens, f = 15-31 mm (2x) Standard eyepiece adaptor Non-detachable 300 cm KARL STORZ HD Flat Screens Color systems PAL/NTSC Version Order No. Screen diagonal Max. screen resolution 1920 1080 Video input Composite signal tobncsocket S-Video to 4-pin Mini-DIN socket VGAto15-pin HD-D-Sub socket DVI to DVI-D socket Wall-mounted with VESA 100 adaptation 9626 NB 26" Pedestal 9626 SF

Data Management and Documentation KARL STORZ AIDA COMPACT NEO ADVANCED Continuous first-class documentation! AIDA COMPACT NEO: Recording screen Data Acquisition Still images, video sequences and spoken comments can easily be recorded during an examination or intervention using the touch screen, footswitch, or camera head buttons. All images are displayed in the right-hand bar in thumbnail size so that still images can be previewed before archiving. Patient data can be entered via an onscreen or standard keyboard. The system also offers the possibility to manage all relevant patient data via a DICOM worklist or a link to the HIS system, eliminating the need for manual entry in the patient entry screen. AIDA COMPACT NEO: Review screen Flexible Review and Documentation, EfficientDataExport Still images or video sequences can be previewed, edited or deleted before final storage on the review screen. KARL STORZ AIDA COMPACT NEO automatically stores the data on DVD, CD, USB flash drive, external/internal hard drive and/or the relevant network on a FTP server. It is also possible to save the data directly on the PACS and/or HIS servers via the HL7/DICOM interface package. Data that cannot be stored successfully remains in a cache until final archiving is possible. AIDA COMPACT NEO: Patient data

14 15 Features and Benefits From still images to FULL HD video recordings through to FULL HD or 720p / SD with AIDA COMPACT NEO ADVANCED (DVI, S-Video, Composite) Picture-In-Picture Function AIDA COMPACT NEO ADVANCED: Recording possible during simultaneous fade-in from channel 2 (SD) to channel 1 (FULL HD) Support for KARL STORZ 19" touchscreen NEW: Support for KARL STORZ SMARTSCREEN (20 0480 20) "Direct Print"- automatically prints imaging material after 1-12 images Includes DICOM/HL7 interface package Scalable watermark with more information AIDA Restore Configuration supports the simple import and export of system settings Flexible User Interface Support for OR1 CHECKLIST V1.1 High-quality function and switching of image and video quality without going to settings Ergonomic operation via touch screen, camera head buttons, and/or footswitch Burns DVDs, reads Blu-ray Data export to DVD/CD, USB flash drive, internal or external hard drives, network path or FTP server Compatible with the KARL STORZ Communication Bus (SCB) and with KARL STORZ OR1 AV NEO and KARL STORZ VOICE1 20 0409 13-XX* KARL STORZ AIDA COMPACT NEO ADVANCED, FULL HD documentation system for digital storage of still images, video sequences and audio files, power supply 115/230 VAC, 50/60 Hz * available in various languages Specifications: Video Systems - PAL - NTSC Video Formats - MPEG2 Signal Inputs Image Formats - S-Video (Y/C) - Composite - RGBS - SDI - HD-SDI - DVI - JPG - BMP Audio Formats Storage Media - WAV - DVD+R - DVD+RW - DVD-R - DVD-RW - CD-R - CD-RW - USB flash drive

Touch Screen Monitors 20 0904 07 19" KARL STORZ Touch Screen, 24V, wall mounting, RS 232, VGA, DVI-D, resolution max. 1280 x 1024 SXGA mode, incl. 3 touch screen covers, power supply 100 VAC 240 VAC, 50/60 Hz, including: RS 232 Connecting Cable, length 300 cm SVGA Monitor Cable, length 300 cm 20 0904 08 19" KARL STORZ Touch Screen, 24V, Desktop, RS 232, VGA, DVI-D, resolution max. 1280 x 1024 SXGA mode, incl. 3 touch screen covers, power supply 100 VAC 240 VAC, 50/60 Hz, including: Pedestal

16 17 CADIERE 5/10 Instrument Set Qty Item No. Description 1 26120 JLL VERESS Pneumoperitoneum Needle 1 30103 AP Trocar, with pyramidal tip, size 11 mm, automatic valve 2 30160 AP Trocar, with pyramidal tip, size 6 mm, automatic valve 2 30107 AP Trocar, with pyramidal tip, size 13 mm, automatic valve 2 30141 HB Reducer, 13/5 mm and 13.5/5 mm 1 26003 BA 1 26775 C HOPKINS Forward-Oblique Telescope 30, diameter 10 mm, length 31 cm CADIERE Coagulating and Dissecting Electrode, L-shaped, size 5 mm, length 36 cm 1 26173 CN CADIERE Needle Holder, size 5 mm, length 33 cm 1 34351 MSC CLICKLINE METZENBAUM Scissors, size 5 mm, length 36 cm 1 37360 LH Suction and Irrigation Tube, size 5 mm, length 36 cm 1 38112 C CADIERE Suction and Irrigation Handle 1 031135-10 Adaptor, for single use, sterile, with LUER-Lock connector and tube olive for suction and irrigation, package of 10, for use with Suction and Irrigation Handle 38112 C 1 031118-10 LAP Tubing Set, for irrigation, for single use, sterile, package of 10 1 33351 ONC 3 33362 ONC CLICKLINE Grasping Forceps, size 5 mm, length 36 cm, plastic handle without ratchet CLICKLINE Grasping Forceps, size 5 mm, length 36 cm, metal handle with MANHES style ratchet

European School of Laparoscopic Surgery The courses in laparoscopic surgery at the Saint-Pierre University Hospital have existed for more than 10 years and it is one of the oldest and most important schools for laparo scopic surgery in Europe. The very best experts of the world have come to teach and since its beginning over 5000 surgeons and fellows have followed the course. For years these courses have been endorsed by the society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and by the European Association for Endoscopic Surgery (EAES). The courses are also transmitted at distance in University Centers around the world including Third World Countries. All the workshops aim to offer the laparoscopic surgeon all the details (tricks and pitfalls) needed in performing advanced laparoscopic procedures. This form of teaching is based on live procedures performed by expert surgeons (highly qualified individuals with technical and teaching expertise). Opportunities to interact with the operative surgeon are provided directly in the operation room. International experts moderate the live surgical procedures either on-site or by videoconferencing. Every subject is classically approached by 4 steps: Laparoscopic anatomy by virtual reality Illustration of the procedure s principles Live demonstrations Discussion on technical details that can be reviewed on CD/DVD Saint-Pierre University Hospital Department of Gastrointestinal Surgery European School of Laparoscopic Surgery 322, Rue Haute 1000 Brussels, Belgium Tel: +32 (0)2 535 41 15 Fax: +32 (0)2 535 31 66 E-mail: coelio@resulb.ulb.ac.be www.lap-surgery.com

18 19 Notes It is recommended to check the suitability of the product for the intended procedure prior to use. Consent to receive electronic information 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 info@karlstorz.com. KARL STORZ will not make these data available to third parties.

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: info@karlstorz.com www.karlstorz.com 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: info@ksea.com 96112023 LAP 55-5 07/2014/EW-E