Macro Handpiece User Manual

User manual MacroMacro-Handpiece Handpiece LUD 5mm 9494-054

Content Funkction Description…………………………………………………………………………………………………………………………………….….1 Disassembly..………………………………………………………………………………………………………………………………………………………3 Assembly..………..…………………………………………………………………………………………………………………………………………………3 Reprocessing…………..………………………………………………………………………………………………………………………………………….4 Spare Parts/Accessories.……………………………………………………………………………………………..………..………………………….7

User manual MacroMacro-Handpiece Handpiece LUD 5mm 9494-054 Function Function Description Area of application: application:

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Recommended for many applications, e.g. laparoscopic/trans vaginal cholecystectomy, fundoplication, sigmoidectomy, Adhesiolysis, partial splenectomy.

Construction Cone Nose Guide tube Sonotrode Transducer

Luer-Lock-aspiration .

connetion

Luer-Lock-irrigation connection

Irrigation port: port : An irrigation hose can be connected to the Luer Lock port of the irrigation channel.

User manual MacroMacro-Handpiece Handpiece LUD 5mm 9494-054 Function Description

Aspiration port:

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An aspiration hose 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. Therefore press the button

filling hose until fluid comes out of the handpiece. After each usage the handpieces must be reprocessed.

User manual MacroMacro-Handpiece Handpiece LUD 5mm 9494-054 Disassembly Handpiece 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. Screw off the guide tube and nose cone from the handpiece.

Guide tube

Nose cone

Assembly Handpiece

1.

Screw Guide tube with nose cone to handpiece.

assembly: assembly :

Guide tube

Nose cone

User manual MacroMacro-Handpiece Handpiece LUD 5mm 9494-054 Reprocessing

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Procedure:

Automated Cleaning-, Desinfection- and Sterilization-Process.

Products:

94-054 LUD 5mm 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. 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

Disconnect the connection cable from the ultrasonic handpiece right

of use:

after application.

Transportation:

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 (see description

Decontamination:

“Disassembly”).

User manual MacroMacro-Handpiece Handpiece LUD 5mm 9494-054 Reprocessing Cleaning:

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Automated Cleaning: Place the disassembled handpiece and the connection cable on a storage rack. The Luer Lock aspiration and irrigation port on the ultrasonic handpieces can be used 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:

•

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:

Automated Drying: Drying of outside of instrument through drying cycle of washer/disinfector.

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.

User manual Macro Macroro-Handpiece LUD 5mm 9494-054 Reprocessing Sterilization:

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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 validation

Washer/disinfector:

study information

Miele G 7735 CD with special insert for MIC instruments 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 MacroMacro-Handpiece LUD 5 mm 9494-054

Spare Parts/Accessories

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Designation:

Article number

Connective cable

240K0194 (angled) 240K0094 (straight)

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