Micro-Suction-Pen Handpieces 92-xxx User Manual Jan 2010

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:

Page 2 of 7

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:

Page 3 of 7

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

Page 4 of 7

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 :

Page 5 of 7

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

Page 6 of 7

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

Page 7 of 7

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