CPC and CPC Micro Handpiece 54-xxx User Manual March 2010

User Manual CPC-Handpiece 54-111, 54-511 and 54-121

Function Function Description

Page 1 of 7

Recommend application for the CPC handpiece 54-111 is e.g. the ENT Area of Application: Application:

(Ear- Nose- Throat) and for the CPC handpieces 54-511 and 54-121 the recommend application is e.g. general surgery and the minimal invasive surgery.

Construction: Construction:

Nose Cone cable

Corpus

Connection to CPC Device: Device:

Use the connective cable to connect the handpiece with the CPC 1000, CPC 1500 or CPC 3000.

ADVICE:

Söring GmbH Medizintechnik

After each usage the handpieces must be reprocessed.

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

User Manual CPC-Handpiece 54-111, 54-511 and 54-121

Disassembly

Page 2 of 7

Handpiece

1.

disassembly: disassembly:

2. To disconnect the probe and the handpiece, the nose cone must be

Disconnect the CPC device and the handpiece cable. loosened

3. When the nose cone has been loosened the probe can easily be pulled out. Attention: NEVER screw off the nose cone completely! 4. The corpus of the handpiece cannot be disassembled.

ADVICE:

Söring GmbH Medizintechnik

The probe is a disposable. Through away after usage!

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

User Manual CPC-Handpiece 54-111, 54-511 and 54-121

Assambly

Handpiece assambly ass ambly

Page 3 of 7

1.

Connect the cable of the handpiece and the device.

2. if needed, loosen the nose cone and 3. Carefully insert the CPC probe into the opening. 4. screw on the nose cone 5. Check, if the probe is fixed.

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

User Manual CPC-Handpiece 54-111, 54-511 and 54-121 Reprocessing

Page 4 of 7

Procedure: Procedure:

Automated Cleaning-, Desinfection- and Sterilization-Process.

Products: Products :

54-111; 54-511 and 54-121

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.

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

Before cleaning, the handpiece must be disassembled (see description

Decontamination: Decontamination:

“Disassembly”).

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

User Manual CPC-Handpiece 54-111, 54-511 and 54-121 Reprocessing Cleaning: Cleaning :

Page 5 of 7

Automated Cleaning: Place the disassembled CPC- handpiece (including the connection cable) on a storage rack. Place rack in the washer/ disinfector. Start washing cycle: Pre-rinse Washing with enzymatic cleanser:

Disinfection: 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: 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 (valid version).

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

User Manual CPC-Handpiece 54-111, 54-511 and 54-121 Reprocessing Steriliz Steriliz ation:

Page 6 of 7

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: 5 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 agent: 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.

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

User Manual CPC-Handpiece 54-111, 54-511 and 54-121

Spare Parts/Accessories Information

Page 7 of 87

Article number 54-111: 25W; Diameter 5 mm 54-511: 100 W; Diameter 5 mm 54-121: 25W; Diameter 3 mm

Probes 654K0301 disposable CPC Laparoscopic probe Diameter 5 mm Length 330 mm 654K0311 disposable CPC Laparoscopic probe Diameter 5 mm Length 120 mm 654S1002 disposable CPC probe Diameter 5 mm Length 70 mm 654S1008 disposable CPC probe Diameter 5 mm Length 330 mm 654S1032 disposable CPC probe Diameter 3 mm Length 80 mm 654S1034 disposable CPC micro probe Diameter 3 mm Length 120 mm

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