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Instruction for use

FlexCrown™ Atrium Retractor

Geister Medizintechnik GmbH Föhrenstraße 2 78532 Tuttlingen / Germany Tel.: +49-7461-96624-0 FAX: +49-7461-96624-22 E-Mail: [email protected]

Read instruction for use

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Medical product higher class I and shortcut for Notified Body TÜV SÜD Production Service GmbH, München, Germany

Non sterile

Batch code

Catalogue number

Prescription - U.S. federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner

Protect from rain

Do not expose to sunlight

Part No. 29-1372 FlexCrown™ Retractor Set with tray 29-1373 FlexCrown™ Catcher 29-1374 FlexCrown™ Introduction Forceps 29-1375 FlexCrown™ Mitral Spring Retractor 29-1375.S FlexCrown™ Mitral Spring Retractor, small

General Description The FlexCrown™ Atrium Retractor is a self-expanding spring retractor system which, after introduction and placement with an applicator , exposes the left atrium for mitral valve repair. The FlexCrown™ Mitral Spring Retractor is provided as a SET with two different sizes. The FlexCrown™ Mitral Spring Retractor is reusable for a maximum number of 100 cases. It can be processed in cleaning and sterilization like a reusable surgical instrument made of stainless steel and nitinol.

Purpose Minimal Invasive Mitral Valve Repair requires a circular exposure of the left atrium to enable access for surgical instruments for reconstruction. The self-expanding FlexCrown™ Mitral Spring Retractor holds the atrial walls open in a flexible circular geometry. The system is adaptive to several anatomic circumstances in size, geometry and positioning. By the simple constriction with a braided polyester band - e.g. Covidien™ 2 x 30`` or SANTEC Surgical Band Polyester Flat woven - the diameter of the FlexCrown™ Mitral Spring Retractor can be sufficiently reduced for passing the intercostal space and place it in the left atrium. The special FlexCrown™ Suture Catcher allows easy placement of the


polyester band/tape while the FlexCrown™ Holding Forceps allows to counter-hold it and keep it in place during constriction.

Mode of instructions All components of the FlexCrown™ Atrium Retractor are delivered in a special tray for washing, sterilization and storage under sterile conditions.

The parts of FlexCrown™ Atrium Retractor Systems are:

29-1373 29-1374 29-1375 & 29-1375.S


For sterilization and storage of a FlexCrown™ Mitral Spring Retractor System follow our separate IFU “Surgical Instruments GA_IFU” which is not part of this IFU. Preparation under sterile conditions before use Open the tray in the sterile field and take out the selected size of the FlexCrown™ Mitral Spring Retractor using your main hands index finger. Carefully remove the metal ring with your other hand while fixing the FlexCrown™ Mitral Spring Retractor between your main hands thumb and long finger. CAUTION: After removing the ring from the FlexCrown™ Mitral Spring Retractor will expand to its maximal size. To comfortably hold the FlexCrown™ Mitral Spring Retractor, position the ADAPTER PART (Picture) between thumb and long finger of your main hand. Then introduce the FlexCrown™ Suture Catcher from outside to inside in the center opening. Catch the polyester band/tape as a loop and pull it approx 10 cm out. Then remove the FlexCrown™ Suture Catcher. Pull the long loop all the way around the FlexCrown™ Mitral Spring Retractor. To avoid slipping out of the polyester band/tape, secure it with your fingers on the ADAPTER PART. Grasp the ADAPTER PART with the FlexCrown™ Holding Forceps and close it. CAUTION: use the designated GRIP AREA only. Put the both open ends of the loops to the ring handle of the FlexCrown™ Holding Forceps. Placement before Mitral Valve Repair For constriction and introduction pull the suture loop carefully until the compression is maximal. CAUTION: do not release and open the FlexCrown™ Mitral Spring Retractor during introduction into the anatomic structures until you placed it into the right position. Carefully open the FlexCrown™ Mitral Spring Retractor by controlled opening of the loop to expand it. CAUTION: Do not remove the loop during the surgical procedure from the FlexCrown™ Mitral Spring Retractor. It allows an easy repositioning and removal after the surgical procedure. Remove the FlexCrown™ Holding Forceps from the ADAPTER PART and store and keep it sterile for a later removal of the FlexCrown™ Mitral Spring Retractor from the patient. CAUTION: During all suturing steps in surgery, make sure that there is no interaction between surgical sutures and parts of the FlexCrown™ Mitral Spring Retractor System. The ADAPTER PART should be positioned towards the upper part of left atrium. It can also be used to put the endoscope beneath it for a more comfortable view and in order to increase operating space. For the removal of the FlexCrown™ Mitral Spring Retractor from the left atrium and the thoracic cavity use the FlexCrown™ Holding Forceps only. Apply it to the GRIP AREA of ADAPTER PART once again and pull the loop to compress the FlexCrown™ Mitral Spring Retractor. Once maximal compression has been achieved, hold the loop carefully before you remove FlexCrown™ Mitral Spring Retractor out. CAUTION: In rare cases of unique anatomic circumstances, it could be that the FlexCrown™ Mitral Spring Retractor does not fit for surgery in this patient. Therefore it is recommended to always hold other systems for exposure of the left atrium in backup. After use put the FlexCrown™ Mitral Spring Retractor back into the HOLDING RING by constriction with the loop. Open the FlexCrown™ Holding Forceps and remove it. Then detach the band/tape loop and place the HOLDING RING in the tray. After surgery, follow standard procedures of sterilization. CAUTION: Implement a counting of cases in use. After maximum 100 cases both sizes of the FlexCrown™ Mitral Spring Retractor have to be replaced for reasons of function and safety.

Caution Please do not touch / contact the NiTiNol wire with the forceps.

For service For any necessary service, please contact your Geister Distributor or Geister Customer Service at the address shown above.

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