User manual. Handpieces. Micro-Suction. Suction-Pen. Usable with Sonoca 300/Sonoca 400 Required Softwareversion: Dok-ID: _R05

Transcription

1 Micro-Suction Suction-Pen Pen-Hand Handpieces , , Dok-ID: _R05 01/2010 Usable with Sonoca 300/Sonoca 400 Required Softwareversion: 4.53

2 Contents Function Description....1 Disassembly Assembly Reprocessing...4 Spare Parts/Accessories.7

3 Function Description Page 1 of 7 Area of Application: Recommended for use during neurosurgical interventions, and dissection of soft and hard tumours. Construction: Cover Nose cone Irrigation connection Aspiration connection Sonotrode Transducer Irrigation port: An irrigation hose can be connected to the Luer Lock port of the irrigation channel. Aspiration port: An aspiration port can be connected to the Luer Lock port of the irrigation channel and to the suction receptacle. Connection to Sonoca: Use the connective cable to connect the handpiece with the Sonoca. ADVICE: The handpieces must be rinsed after usage. After each usage the handpieces must be reprocessed.

4 Disassembly Page 2 of 7 Handpiece disassembly: 1. Separate the connecting cable from the ultrasonic handpiece right after use. When doing so, make sure to grasp the cable connectors at the transducer only and pull to seperate. Disconnect the aspiration hose and the irrigation hose from the handpiece. 2. Pull Cover from the handpiece 3. Unscrew nose cone

5 Assembly Assembly Page 3 of 7 Handpiece assembly: 1. Srew nose cone to handpiece 2. Push Cover on to nose cone

6 Reprocessing Page 4 of 7 Procedure: Automated Cleaning-, Desinfection- and Sterilization-Process. Products: , , Ultrasonic-Handpieces. ADVICE: 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. Technical safety inspections have to be done once a year. Verify that the instrument is in perfect conditions before using it. Defective handpieces/cables must be cleaned and sterilized. Then they can be sent to the address given below for repair and/or proper disposal. Unprocessed items not properly conditioned incur additional charges for the sender! Before usage the handpieces must be reprocessed, also before first use because they were delivered unsterile. Preparation at the Point of use: Disconnect the connection cable from the ultrasonic handpiece right after application. Transportation ation: Safe storage and transportation in a closed container to the reprocessing area to avoid any damage and contamination to the environment. Preparation for Decontamination: Prior to cleaning, the handpiece must be disassembled according to the Disassembly Instructions.

7 Reprocessing Page 5 of 7 Cleaning: Automated Cleaning: Place the disassembled handpiece and the connection cable on a storage rack. Use the Luer Lock aspiration and irrigation port on the ultrasonic handpieces as a flushing port for the cleaning programme during automatic reconditioning! Place rack with disassembled handpiece and connecting cable into the washer disinfector. Start washing cycle: Pre-rinse Washing with enzymatic cleanser: 45 C 5 min Disinfection tion: 93 C 5 min Automated Disinfection: Automated Thermal Disinfection in washer/disinfector under consideration of national requirements in regards to A0-Value (see EN 15883). Drying: Automated Drying: Drying of outside of instrument through drying cycle of washer/disinfector.

8 Reprocessing Page 6 of 7 Functional Testing, Maintenance: 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 and EN 868. Sterili terilization: Sterilization of instruments by applying a fractionated pre-vacuum process (according to ISO / ISO17665) under consideration of the respective country requirements. Parameters for the pre-vacuum cycle: Fractioned prevacuum procedure Sterilisation temperature: 134 C Minimum hold time: 4 min Storage: Storage of sterilized instruments in a dry, clean and dust free environment at modest temperatures of 5 C to 40 C. Reprocessing Washer/disinfector: validation study Miele G 7735 CD with special insert for MIC instruments information Programme 29 VARIO TD Used cleaning and neutralising agents: Neodisher Medizym (Dr. Weigert) - enzymatic cleanser Steriliser: AD LINDEN; Type: 336 D.E.C.E. Additional instructions: The reconditioner is obliged to validate his reconditioning process if the chemicals and/or machines quoted are no available. It is the reconditioner s responsibility that reconditioning carried out with the equipment, material and staff actually available in the reconditioning shop yields the desired results. This normally requires a validation and regular monitoring of the procedure. It is mandatory to heed the current state of technology as well as national regulations applicable to reconditioning.

9 Spare Parts/Accessories Page 7 of 7 Designation: Article number Connective cable 240K0195 (angled) 240K0095 (straight) Cover for Handpiece pu=10, 612K pu=50, 612K Cover for Handpiece pu=10, 612K pu=50, 612K Cover for Handpiece pu=10, 612K pu=50, 612K Further accessories: See Accessories Order List Söring GmbH Medizintechnik Tel.: +49-(0)4106/ Justus-von-Liebig-Ring 2 Fax: +49-(0)4106/ D Quickborn info@soering.com GERMANY