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User manual MicroMicro-SuctionSuction-PenPen-Handpieces Handpieces 9292 -020, 9292-021, 9292-112
0123 Dok-ID: 03-2002_R05 01/2010
Usable with Sonoca 300/Sonoca 400 Required Softwareversion: 4.53
User manual Micro-Suction-Pen Handpieces 92-020, 92-021, 92-112
Contents Function Description…..………………………………………………………………………………………………………………………………….….1 Disassembly..………………………………………………………………………………………..…………………………………………………………….2 Assembly……………………………………………………………...………………………………………………………………………………………….…3 Reprocessing…………..………………………………………………………………………………………………………………………………………….4 Spare Parts/Accessories…………………………………………………………………………………………………………………………………….7
User manual Micro-Suction-Pen Handpieces 92-020, 92-021, 92-112
Function Function Description Area of Application: Application:
Page 1 of 7
Recommended for use during neurosurgical interventions, and dissection of soft and hard tumours.
Construction: Construction: Nose cone
Irrigation connection
Cover
Aspiration connection Sonotrode
Irrigation port: port :
Transducer
An irrigation hose can be connected to the Luer Lock port of the irrigation channel.
Aspiration port: port :
An aspiration port can be connected to the Luer Lock port of the irrigation channel and to the suction receptacle.
Connection to Sonoca: 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.
User manual Micro-Suction-Pen Handpieces 92-020, 92-021, 92-112
Disassembly Handpiece disassembly: disassembly:
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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
User manual Micro-Suction-Pen Handpieces 92-020, 92-021, 92-112
Assembly Handpiece Handp iece assembly: assembly:
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1.
Srew nose cone to handpiece
2.
Push Cover on to nose cone
User manual Micro-Suction-Pen Handpieces 92-020, 92-021, 92-112
Reprocessing
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Procedure: Procedure:
Automated Cleaning-, Desinfection- and Sterilization-Process.
Products: Products :
92-020, 92-021, 92-112 Ultrasonic-Handpieces.
ADVICE: 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
Disconnect the connection cable from the ultrasonic handpiece right after
Point of use: use:
application.
Transportation Transport ation: ation:
Safe storage and transportation in a closed container to the reprocessing area to avoid any damage and contamination to the environment.
Preparation for
Prior to cleaning, the handpiece must be disassembled according to the
Decontamination: Decontamination:
Disassembly Instructions.
User manual Micro-Suction-Pen Handpieces 92-020, 92-021, 92-112
Reprocessing Cleaning: Cleaning :
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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:
Disinfection Disinfection: tion:
•
45°C
•
5 min
•
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: Drying :
Automated Drying: Drying of outside of instrument through drying cycle of washer/disinfector.
User manual Micro-Suction-Pen Handpieces 92-020, 92-021, 92-112
Reprocessing
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Functional Testing,
Visual inspection for cleanliness, assembling and functional testing
Maintenance:
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.
Steriliz teriliz ation:
Sterilization of instruments by applying a fractionated pre-vacuum process (according to ISO 13060 / ISO17665) under consideration of the respective country requirements. Parameters for the prepre-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.
User manual Micro-Suction-Pen Handpieces 92-020, 92-021, 92-112
Spare Parts/Accessories Parts/Accessorie s
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Designation:
Article number
Connective cable
240K0195 (angled) 240K0095 (straight)
Cover for Handpiece 92-020
pu=10, 612K0037-10 pu=50, 612K0037-50
Cover for Handpiece 92-021
pu=10, 612K0038-10 pu=50, 612K0038-50
Cover for Handpiece 92-112
pu=10, 612K0039-10 pu=50, 612K0039-50
Further accessories: See Accessories Order List
Söring GmbH Medizintechnik
Tel.: +49-(0)4106/6100-0
Justus-von-Liebig-Ring 2
Fax: +49-(0)4106/6100-10
D-25451 Quickborn
E-mail: [email protected]
GERMANY
www.soering.com