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Related Manuals for KLS Martin ME102
Summary of Contents for KLS Martin ME102
- Page 1 Electrosurgical Unit ME 102 Instructions for Use V. 3.1-EN (11.13)
- Page 2 Quick Instructions for Use ME 102 For the assignment of the numbering, see section 4.2 “Functions of the Control Elements, Connections and Displays”, page 12. V. 3.1...
- Page 3 Symbol explanation Safety alert symbol CAUTION Indicates a situation which, if not avoided, could result in minor or moderate injury. WARNING Indicates a situation which, if not avoided, could result in death or serious injury. DANGER Indicates a situation which, if not avoided, will result in death or serious injury.
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Page 4: Table Of Contents
Instructions for Use Electrosurgical Unit ME 102 Contents Product Liability and Warranty ............6 General Information ................6 Scope of Delivery .................. 6 Intended Use ..................6 Warranty ..................... 7 User’s Inspection .................. 7 Hotline....................8 Notices concerning this Document ..........9 Symbols Used in this Document .............. - Page 5 Instructions for Use Electrosurgical Unit ME 102 Safety Measures................. 24 General Information ................24 Patient Placement ................24 Application of the Neutral Electrode ............25 Working with the Active Electrode ............27 Use of Two Electrosurgical Devices on One Patient ........28 Work on Patients with Pacemakers or Other Implants ......
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Page 6: Product Liability And Warranty
Product Liability and Warranty General Information We thank you for having decided to buy a KLS Martin product. This product carries the CE mark, which means that it satisfies the essential requirements laid down in the EC Directive concerning medical devices. -
Page 7: Warranty
Instructions for Use Electrosurgical Unit ME 102 Warranty Our Standard Terms and Conditions of Sale effective at the time shall apply. Agreements di- verging from these Standard Terms and Conditions do not restrict the legal rights of the buyer. Any warranty exceeding the above provisions shall require a contractual form and shall exclude component-related vandalism, software updates and consumables. -
Page 8: Hotline
Instructions for Use Electrosurgical Unit ME 102 Hotline Should you have any questions on how to handle the product or use it for clinical • applications, please do not hesitate to contact the Product Management: Tel: +49 7461 706-243 Fax: +49 7461 706-190 Should you have any technical questions, please do not hesitate to turn to our •... -
Page 9: Notices Concerning This Document
Instructions for Use Electrosurgical Unit ME 102 Notices concerning this Document Non-observance of this document can lead to serious or even lethal patient injury! Improper handling and care as well as non-intended use can lead to premature wear and / or pose a risk to patients and users! Be sure to read, understand and follow the instructions given below! •... -
Page 10: Functional Principle
Instructions for Use Electrosurgical Unit ME 102 Functional Principle Monopolar Functional Principle The electrosurgical unit ME 102 is a generator that converts electrical energy from the grid into a high-frequency current. This high-frequency current is fed to a point-shaped active electrode via a supply line or a handle. -
Page 11: Commissioning
Instructions for Use Electrosurgical Unit ME 102 Commissioning Technical Specification The electrosurgical unit can be used universally and has excellent performance data. The unit meets the latest safety standards. The unit is characterized by the following constructional characteristics: The characteristics of the RF generator result in automatic power adjustment for different •... -
Page 12: Functions Of The Control Elements, Connections And Displays
Instructions for Use Electrosurgical Unit ME 102 Functions of the Control Elements, Connections and Displays 1 Mains switch 2 MICRO button 3 Connection for monopolar handle 4 Sockets for 3-pin handle 5 Connection for neutral electrode 6 Indicator LED for neutral electrode alarm V. - Page 13 Instructions for Use Electrosurgical Unit ME 102 7 Switch button monopolar PURE CUT / BLEND CUT 8 Activation LED monopolar cutting 9 Power controller monopolar cutting 10 Activation LED monopolar coagulation 11 Power controller monopolar coagulation 12 Activation LED bipolar coagulation 13 Power controller bipolar coagulation 14 Connection for bipolar instruments 15 Switch button for foot switch activation (bipolar)
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Page 14: Mains Connection
Instructions for Use Electrosurgical Unit ME 102 Mains Connection For the assignment of the numbering, see section 4.2 “Functions of the Control Elements, Connections and Displays”, page 12. Before initial switching on of the unit, ensure that your grid complies with the voltage setting of the unit indicated on the label (next to the power input). -
Page 15: Monopolar Operation
LED (6) goes dark after reaching a safe application state when a multi-surface electrode (e. g. KLS Martin TWIN-PAD) is correctly connected. As in this case individual run-in times are to be expected, a lead time for the application must be considered. -
Page 16: Connection Of Handles
(3). • Pay attention to the information in the accessories catalog of KLS Martin. Handles without finger switch or surgical RF instruments without switch function (e. g. resectoscopes) are also connected to socket (3). The corresponding double-pedal foot switch is connected to socket (19) on the rear of the unit. -
Page 17: Selecting The Monopolar Current Type
Instructions for Use Electrosurgical Unit ME 102 4.6.3 Selecting the Monopolar Current Type The unit has three monopolar operating modes: Monopolar cutting 1 • Monopolar cutting 2 • Monopolar contact coagulation • The front is divided into two control fields for distinction of the monopolar operating modes: In the control field on the monopolar unit side that is marked yellow, an indicator LED (8) indicates activation of the monopolar cutting current, and there are two different current types available for cutting:... -
Page 18: Setting The Monopolar Cutting Power
Instructions for Use Electrosurgical Unit ME 102 4.6.5 Setting the Monopolar Cutting Power Use the power controller (9) for setting the cutting power. The power setting is adjusted from a preset minimum value to a maximum value depending on the selected cutting current type and the MICRO function. The output power increases in roughly linear relation to the rotation angle;... -
Page 19: Monopolar Operating Mode
Instructions for Use Electrosurgical Unit ME 102 4.6.7 Monopolar Operating Mode Failure to comply with the patient and user rules for the application of electrosurgery explained in section 5 “Safety Measures”, page 24, may result in severe and even lethal injury! Ensure safe application of the neutral electrode and correct positioning of the patient. -
Page 20: Bipolar Operation
Instructions for Use Electrosurgical Unit ME 102 CAUTION Risk of malfunction, risk of injury! If the RF activation signal can be heard when no double foot switch or electrode handle is connected, the unit is defective. The unit must not be operated. •... -
Page 21: Selecting The Bipolar Operating Mode
Instructions for Use Electrosurgical Unit ME 102 4.7.3 Selecting the Bipolar Operating Mode On the right control field Bipolar Coag that is marked blue on the front plate there are two selection possibilities: Via the single-pedal foot switch that is connected to socket (20) on the rear of the unit •... -
Page 22: Bipolar Power Setting
Instructions for Use Electrosurgical Unit ME 102 4.7.5 Bipolar Power Setting Use the power controller (13) for setting the bipolar output • power. The power setting is adjusted from a preset minimum value to a • maximum value depending on the selected current type (see section 9 “Technical Data”, page 35). -
Page 23: Bipolar Functional Check
Instructions for Use Electrosurgical Unit ME 102 4.7.7 Bipolar Functional Check The neutral electrode does not have to be connected for bipolar operation. As described in section 5.3 “Application of the Neutral Electrode”, page 25, we recommend connecting the neutral electrodes even for bipolar mode. All functions of the unit must be checked before using the unit. -
Page 24: Safety Measures
Instructions for Use Electrosurgical Unit ME 102 Safety Measures General Information Electrosurgical devices are high-frequency generators designed to create high voltages and currents. In order to avoid hazards to the patient, the operators and third parties, the procedure must be applied carefully, and the operating and safety notes must be strictly observed. -
Page 25: Application Of The Neutral Electrode
Instructions for Use Electrosurgical Unit ME 102 Application of the Neutral Electrode NOTICE Danger of burns from missing warning signal in case of one-piece neutral electrodes! A one-part neutral electrode cannot be monitored. In case of insufficient contact, there will be no warning signal! The control of the RF output power can be limited for some monopolar cutting currents by one-piece, large-area neutral electrodes that do not come into direct contact with the patient's skin (so-called capacitive neutral electrodes). - Page 26 Instructions for Use Electrosurgical Unit ME 102 WARNING Risk of burns from improper handling of the neutral electrode! In order to minimize the risk of burns or other problems in the area of the neutral electrode, during application of the neutral electrode please mind the following: The neutral electrode must butt against the patient's body as close to the operation field •...
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Page 27: Working With The Active Electrode
Instructions for Use Electrosurgical Unit ME 102 Working with the Active Electrode Observe the following rules when using high-frequency surgery: When simultaneously using electrosurgery and monitors on the same patient, use only • monitoring electrodes whose leads comprise protective resistors or RF reactors. Needle electrodes must not be used for monitoring. -
Page 28: Use Of Two Electrosurgical Devices On One Patient
The following rules are to be observed in the concomitant operation of two electrosurgical devices: Only electrosurgical units with type CF application parts by KLS Martin may be used. • Each unit to be operated in monopolar application requires a neutral electrode separately •... -
Page 29: Cable Routing On The Patient
Instructions for Use Electrosurgical Unit ME 102 Cable Routing on the Patient During simultaneous use of the monopolar and bipolar application ensure that the respective lines have a minimum distance of 10 cm to each other. The lines must be laid out loosely and without loops. -
Page 30: Additional Safety Notes
Instructions for Use Electrosurgical Unit ME 102 5.11 Additional Safety Notes During operations on low-diameter body parts, bipolar technology can be used to avoid • unintentional coagulation in other areas. Use of flammable anesthetics, nitrous oxide (N O) and oxygen must be avoided. Sparking •... -
Page 31: Cleaning And Disinfection
Instructions for Use Electrosurgical Unit ME 102 Cleaning and Disinfection The operator / user is responsible for cleaning and disinfecting the device. National regulations regarding cleaning and hygiene are to be complied with. WARNING Risk of serious injury from defective accessories! A non-functional unit or defective accessories can endanger the patient or user, as well as affect the intended functions of the unit. -
Page 32: Safety Checks (Sc)
Instructions for Use Electrosurgical Unit ME 102 Safety Checks (SC) At least every 24 months the system must be subjected to the following controls to be performed by people who, by virtue of their training, knowledge and experience gained from practical activities are able to properly perform such safety checks and who are not obliged to adhere to instructions with regard to such control activities. -
Page 33: Accessories
In case of doubt, consult the manufacturer. The accessories certified for electrosurgical units by KLS Martin can be taken from the accessories catalog of KLS Martin which can be requested or directly downloaded from www.klsmartin.com. -
Page 34: Technical Data
Instructions for Use Electrosurgical Unit ME 102 Technical Data Description Data electrosurgical unit ME 102 100 – 127 V / 220 – 240 V; 50 – 60 Hz Mains Connection adjustable via solder bridge inside the unit without RF output approx. -
Page 35: Diagrams
Instructions for Use Electrosurgical Unit ME 102 Diagrams 10.1 Performance Diagrams Macro Mode Cutting 1 Cutting 2 Load resistance in ohms Load resistance in ohms Pos. 10 = Power controller 10 Pos. 5 = Power controller 5 Coagulation Bipolar coagulation Load resistance in ohms Load resistance in ohms Pos. -
Page 36: Performance Diagrams Micro Mode
Instructions for Use Electrosurgical Unit ME 102 10.2 Performance Diagrams Micro Mode Cutting 1 Micro Cutting 2 Micro Load resistance in ohms Load resistance in ohms Pos. 10 = Power controller 10 Pos. 5 = Power controller 5 Coagulation Micro Bipolar coagulation Micro Load resistance in ohms Load resistance in ohms... -
Page 37: Voltage Diagrams
Instructions for Use Electrosurgical Unit ME 102 10.3 Voltage Diagrams Cutting 1 Cutting 2 Setting Setting Coagulation Bipolar coagulation Setting Setting V. 3.1... -
Page 38: Guidelines And Manufacturer's Declaration Regarding Electromagnetic Compatibility (Emc)
Instructions for Use Electrosurgical Unit ME 102 Guidelines and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC) Guidance and manufacturer’s declaration according to IEC 60601-1-2, clause 6.8.3.201 a) 3) Table 201: Electromagnetic emission The device ME 102 is intended for use in an electromagnetic environment as specified below. The user should assure that it is used in such an environment. - Page 39 Instructions for Use Electrosurgical Unit ME 102 Guidance and manufacturer’s declaration according to IEC 60601-1-2, clause 6.8.3.201 a) 3) Table 201: Electromagnetic emission The device is intended for use in an electromagnetic environment as specified below. The user should assure that it is used in such an environment. IEC 60601 Electromagnetic Immunity test...
- Page 40 Instructions for Use Electrosurgical Unit ME 102 Guidance and manufacturer’s declaration according to IEC 60601-1-2, clause 6.8.3.201 b) Table 204: Electromagnetic immunity The device is intended for use in an electromagnetic environment as specified below. The user should assure that it is used in such an environment. IEC 60601 Compliance Immunity test...
- Page 41 Electrosurgical Unit ME 102 Recommended separation distances between portable and mobile RF telecommunications equipment and the KLS Martin device according to IEC 60601-1-2 clause 6.8.3.201 b), Table 206 The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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Page 42: Ecological Information
Instructions for Use Electrosurgical Unit ME 102 Ecological Information 12.1 Disposal of Packing Gebrüder Martin will, as a matter of course, take back the full packaging if so desired, to recycle as many parts of the packaging as possible. If you do not wish to make use of this offer, you can dispose of the packaging with the normal paper or domestic garbage. - Page 43 Instructions for Use Electrosurgical Unit ME 102 V. 3.1...
- Page 44 Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group KLS Martin Platz 1 · 78532 Tuttlingen · Germany Postfach 60 · 78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax 706-193 info@klsmartin.com · www.klsmartin.com Date of Release: 11.13 ·...
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