Endoscopic Technology Operating Manual AlphaPort Cannula system
This manual contains proprietary information that is protected by copyright. All rights are reserved. This manual or excerpts thereof may not be reproduced by photocopy, microfilm, or other means, or otherwise distributed without the express written consent of GIMMI. Names that are registered trademarks have not been identified as such. The absence of such identification should not be regarded as evidence that a name is not registered as a trademark. GIMMI would appreciate any comments from users regarding possible errors or unclear passages in this manual. Since the improvement of our products is an ongoing process, we reserve the right to make design changes without notice. Technical data is subject to change without notice. CE- labeling according to directive 93 / 42 / EEC Version: T.808X.XX_02 2
INTENDED use Endoscopic Technology AlphaPort Cannula allows entrance into the abdominal cavity. Optics and instruments are inserted through a cannula. This series has a silicon-valve, which replaces the complex mechanics of separate opening lever and at the same time reduces the weight of the Cannula. Caution: Federal law restricts this device to sale by or on order of a physician! Disassembly/Assembly with Luer Lock 06 01 02 05 03 04 01 Tube 02 Housing 03 Screw cap 04 Sealing Cap 05 Silicon Valve 06 LUER-LOCK Cap Disassembly of Cannula Please, disassemble only pre-washed instruments. Remove Sealing Cap 04. Disassemble Screw Cap 03 and Housing 02. Remove the Silicon Valve 05. Remove the Luer Lock cap 06. Screw off Tube 01. The Trocar-Sleeve is now completely disassembled. Assembly of Cannula Assemble Sealing Cap 04 on Screw Cap 03. Press Silicon Valve 05 in the opposite opening of Valve Part 03. Assemble housing 02 and Screw Cap 03. Luer Lock Cap 06 must be pressed on Luer Lock solid. Screw on Tube 01 into Housing 02. Check the instruments visual for cleanliness and assembling for proper function. The Cannula is now completely assembled. 3
Disassembly/Assembly with Stopcock 12 07 08 11 09 10 07 Tube 08 Housing with Stopcock 09 Screw Cap 10 Sealing Cap 11 Silicon Valve 12 Stopcock Disassembly of Cannula Please, disassemble only pre-washed instruments. Remove Sealing Cap 10. Disassemble Screw Cap 09 and Housing 08. Remove the Silicon Valve 11. Unscrew the stopcock cap and take the stopcock tap out of the stopcock body 12. Screw off Tube 07. The Cannula is now completely disassembled. Assembly of Cannula Assemble Sealing Cap 10 on Screw Cap 09. Press Silicon Valve 11 onto the opposite opening of Screw Cap 09. Assemble housing 08 and Screw Cap 09. Make sure that the guidance pin of the stopcock tap runs in the guide canal and that the lever points in direction outlet in open condition. Fix the stopcock tap with the stopcock cap 12. Screw on Tube 07 into Housing 08. Check the instruments visual for cleanliness and assembling for proper function. The Cannula is now completely assembled. 4
Endoscopic Technology Procedure: Products: ADVICE: Reprocessing Instructions Preparation at the Point of Use: Transportation: Preparation for Decontamination: Pre-Cleaning: Automated Cleaning: Disinfection: Automated Cleaning Process AlphaPort Trocar system super light with slicone valve and thread Reprocessing procedures have only limited implications to a surgical instrument. The limitation of the numbers of reprocessing procedures is therefore determined by the function / wear of the device. Sealing Cap and silicon valve must be inspected after each use and replaced when damage is noticed. In case of damage the device should be reprocessed before sending back to the manufacturer for repair. Remove gross soiling by submerging the instrument into cold water (<40 C) immediately after use. Don t use a fixating detergent or hot water (>40 C) as this can cause the fixation of residua which may influence the result of the reprocessing process. Safe storage and transportation in a closed container to the reprocessing area to avoid any damage and contamination to the environment. The devices must be reprocessed in an opened or disassembled state. Immerse the instrument into cold tap water for at least 5 minutes. Dismantle the instruments If possible and brush under cold tap water until all visible residues are removed. Inner lumens, threads and holes are flushed each with a water jet pistol for minimum 10 seconds in the pulsed mode Immerse the instrument into an ultrasonic bath with alkaline or enzymatic detergent (0,5%) and treat with ultrasonic for 15 minutes at 40 C. The instrument is taken out of the bath and rinsed with cold tab water again. In order to optimize the cleaning prozess we recommend the use of distilled,demineralized or fully desalinated water. Put the instruments in a disassembled state on a special key hole surgery. rack. Not suitable instruments are placed on an instrument tray below and start the cycle: 1. 1 min. pre-cleaning with cold water 2. draining 3. 3 min. pre-cleaning with cold water 4. draining 5. 5 min cleaning at 55 C, 45 C with 0,5 % alkaline detergent or if enzymatic detergent is used the cleaning temperature is 45 C. 6. draining 7. 3 min neutralization with warm water (>40 C) and neutralizer 8. draining 9. 2 min rinse with warm water (>40 C) 10. draining Please follow the Operation instructions of the detergent s manufacturer Automated Disinfection: Automated Thermal Disinfection in washer/disinfector under consideration of national requirements in regards to A0-Value (see ISO 15883) Final rinse with distilled,demineralized or fully desalinated water. 5
Drying: Functional Testing, Maintenance: Automated Drying: Drying of outside of instrument through drying cycle of washer/disinfector. If needed, additional manual drying can be performed through lint free towel. Insufflate cavities of instruments by using sterile compressed air. Visual inspection for cleanliness, assembling and functional testing according to instructions of use. If necessary perform reprocessing process again until the instruments are visibly clean. Packaging: Appropriate packaging for sterilization according ISO 11607 and EN 868 Sterilization: Storage: Reprocessing validation study information Sterilization of instruments by applying a fractionated pre-vacuum process (according. ISO 13060 / ISO17665) under consideration of the respective country requirements. Parameters for the pre-vacuum cycle: 3 prevacuum phases with at least 60 milli bar Heat up to a minimum sterilization temperature of 132-134 C; maximum temperature 137 C Pressure: 2.0-2.3 bar Minimum Holding time: 4 min Drying time: minimum 10 min AlphaPort instruments can also be sterilized (autoclaved) in assambled condition with the Luer Lock cleaning port or stopcock in an open position. Storage of sterilized instruments in a dry, clean and dust free environment at modest temperatures of 5 C to 40 C. The following testing test devices, materials & machines have been used in this validation study; Detergent: Neodisher FA; Dr. Weigert; Hamburg Endozime, Fa. Ruhof (Enzymatic) Neutralizer: Neodisher Z; Dr. Weigert, Hamburg Washer / Disinfector: Miele 7735 CD Instrument Rack: Miele E 327-06 Key Hole Surgery Rack Miele E 450 Details: Cleaning: 01707011901-2 / 01707011901-3 Sterilization: 17308022611 / 11m128 Additional Instructions: If the described chemistry and machines are not available, it is the duty of the user to validate their process It is the duty of the user to ensure that the reprocessing processes including resources, materials and personnel are capable to reach the required results. State of the art and often national law requiring these processes and included resources to be validated and maintained properly. 6
Endoscopic Technology Repairs Do not carry out any repairs by yourself. All guarantee and warranty claims are lost if the repairs are done by any person not authorized by GIMMI or GIMMI. Additionally, the GIMMI warranty for the surgical instrument is void if a repair is done by an unauthorized repair shop. Then GIMMI is no longer responsible for the original specification and for the safety standards of the product. Please ensure that surgical instruments returned to GIMMI for repair or servicing have been thoroughly cleaned, disinfected and sterilized. GIMMI may refuse to repair uncleaned or contaminated products. 7
Your Dealer Manufacturer GIMMI GmbH Carl-Zeiss-Straße 6 D- 78532 Tuttlingen Endoscopic Technology Phone +49 74 61 / 96 590-0 Fax +49 74 61 / 96 590-33 contact@gimmi.de www.gimmi.de www.gimmi-germany.com