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KLS Martin ME102, Инструкция по эксплуатации

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Instructions for Use 

Electrosurgical Unit ME 102 

V. 3.1 

25 

5.3

 

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). This can lead to the 
full power being emitted to the patient. 

•

 

We therefore generally recommend using a two-piece disposable neutral electrode that 
ensures the continuous monitoring of the patient. 

•

 

If a monopolar RF current is to be used, then a neutral electrode must be placed on the 
patient. Also in cases where bipolar application is intended but additional application of 
monopolar electricity is likely in case of complications, a neutral electrode should at least 
be kept ready. 

 

Содержание ME102

Страница 1: ...Electrosurgical Unit ME 102 Instructions for Use V 3 1 EN 11 13...

Страница 2: ...2 V 3 1 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...

Страница 3: ...dicates a situation which if not avoided will result in death or serious injury Observe instructions for use Item number Item no Manufacturer NON WOOD The packaging is non wood i e wood packaging mate...

Страница 4: ...12 4 3 Mains Connection 14 4 4 Equipotential Bonding Connection 14 4 5 Switching On Off 14 4 6 Monopolar Operation 15 4 6 1 Connection of the Neutral Electrode 15 4 6 2 Connection of Handles 16 4 6 3...

Страница 5: ...nt 29 5 8 Putting Down RF Instruments 29 5 9 Interference with Other Devices 29 5 10 Accessories 29 5 11 Additional Safety Notes 30 6 Cleaning and Disinfection 31 7 Safety Checks SC 32 8 Accessories 3...

Страница 6: ...gulation of live human or animal tissue The operator may operate the device only if an on site functional test has previously been performed by Gebr der Martin or a person authorized by Gebr der Marti...

Страница 7: ...der Martin to perform such work If the repair is carried out by a person or firm specially authorized by Gebr der Martin the operator of the product is required to obtain from the repairer a certific...

Страница 8: ...343 Fax 49 7461 706 408 E mail service klsmartin com Should you have any questions concerning maintenance contracts or training courses please contact our Technical Service Manager Tel 49 7461 706 33...

Страница 9: ...is Document Throughout this document important information such as general or safety related notices is marked with the following symbols and signal words WARNING Danger of death or serious injury Ind...

Страница 10: ...energy transport through the patient up to the neutral electrode that is applied to a larger area the concentration of the current is further reduced Therefore there is in accordance with its intende...

Страница 11: ...knob All connections for active electrodes and neutral electrodes are located on the front side Two current types for cutting Smooth cutting and cutting with eschar formation One monopolar current ty...

Страница 12: ...102 12 V 3 1 4 2 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 electrod...

Страница 13: ...ch activation bipolar 16 Switch button for bipolar automatic operation 17 Connection for mains cable mains fuses 1 T2 0 AH for mains voltage 100 127 VAC 1 T1 0 AH for mains voltage 220 240 VAC G 5 20...

Страница 14: ...separate the unit from the grid in the event of danger either the power socket of the unit or the outlet into which the mains cable is plugged in should remain accessible For the decommissioning of t...

Страница 15: ...state via the finger or foot switch there will be an additional acoustic warning signal The RF current cannot be activated This does not affect the bipolar coagulation current The indicator LED 6 goe...

Страница 16: ...tion 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...

Страница 17: ...essed Cutting 1 Clean cut without eschar formation Button 7 pressed and flashing Cutting 2 Cutting current with low eschar formation In the control field that is marked blue on the front plate of the...

Страница 18: ...een in the diagrams for the monopolar current types Setting Cutting 1 Setting Cutting 2 Power output in watts Power output in watts Setting Setting 4 6 6 Setting the Monopolar Coagulation Power Use th...

Страница 19: ...functions of the unit must be checked before using the unit The following functional checks must be performed Remove plug of the connection cable for the neutral electrode from the connection socket 5...

Страница 20: ...This accessory must not be used It must be replaced 4 7 Bipolar Operation For the assignment of the numbering see section 4 2 Functions of the Control Elements Connections and Displays page 12 4 7 1 F...

Страница 21: ...r RF activation Bipolar coagulation via automatic operation While the automatic button is selected button flashes the bipolar coagulation current is automatically activated when both electrodes of the...

Страница 22: ...iagram for the bipolar current type Setting bipolar coagulation Setting 4 7 6 Bipolar Operating Mode For the bipolar operating mode the current type Bipolar coagulation must be activated or For activa...

Страница 23: ...ia the foot switch The activation LED 12 must light up and the RF activation signal must sound Press the switch button 16 for the bipolar automatic activation system Touch a saline soaked swab with th...

Страница 24: ...rained in the proper and safe use of the unit The Instructions for Use are to be adhered to in instruction and application Safe use of electrosurgery requires the user to be familiar with the technolo...

Страница 25: ...e area neutral electrodes that do not come into direct contact with the patient s skin so called capacitive neutral electrodes This can lead to the full power being emitted to the patient We therefore...

Страница 26: ...electrodes must be laid out without loops and so that they cannot touch the patient or other cables Use only cables that are intended for use with the device according to the manufacturer s instructi...

Страница 27: ...minimum distance 15 cm The high frequency power should be set to the lowest possible setting for the respective application WARNING Danger of burns from defective active electrodes Application of a cu...

Страница 28: ...rode must not overlap or intersect To this end always place each neutral electrode in the immediate vicinity of the operation field The total power of the simultaneously applied currents must not exce...

Страница 29: ...eration of other electromedical units e g ECG monitoring and electrical devices e g telephone personal computer To avoid or reduce such interference the following countermeasures can be taken Connect...

Страница 30: ...is the risk of accumulations of combustible liquid under the patient or in depressions such as the navel or in body cavities such as the vagina Liquid that has accumulated in such areas must be remove...

Страница 31: ...nit must be disconnected from the grid When handling cleaning agents and disinfectants no liquid may enter the unit Use of spray is not allowed Never clean the unit with scouring agents disinfectants...

Страница 32: ...target value actual value comparison of the maximum output power on all outputs for all available operating modes on the indicated nominal load resistances see section 9 Technical Data page 34 Check a...

Страница 33: ...other manufacturers may constitute a source of danger In case of doubt consult the manufacturer The accessories certified for electrosurgical units by KLS Martin can be taken from the accessories cata...

Страница 34: ...00 Vss Bipolar coagulation max 80 W 20 at 100 1 9 440 Vss Current type Micro mode Output Crest factor Voltage Cutting 1 max 30 W 20 at 600 1 8 600 Vss Cutting 2 max 30 W 20 at 600 2 3 800 Vss Contact...

Страница 35: ...1 Cutting 2 RF power in watts RF power in watts Load resistance in ohms Load resistance in ohms Pos 10 Power controller 10 Pos 5 Power controller 5 Coagulation Bipolar coagulation RF power in watts RF...

Страница 36: ...Micro RF power in watts RF power in watts Load resistance in ohms Load resistance in ohms Pos 10 Power controller 10 Pos 5 Power controller 5 Coagulation Micro Bipolar coagulation Micro RF power in wa...

Страница 37: ...ical Unit ME 102 V 3 1 37 10 3 Voltage Diagrams Cutting 1 Cutting 2 RF voltage in volts peak RF voltage in volts peak Setting Setting Coagulation Bipolar coagulation RF voltage in volts peak RF voltag...

Страница 38: ...t Guidance RF emissions according to EN 55011 Group 2 The device uses electromagnetic energy exclusively for the performance of its internal functions This may cause interference in nearby electronic...

Страница 39: ...or hospital environment Surge according to IEC 61000 4 5 1 kV differential mode voltage 2 kV common mode voltage 1 kV differential mode voltage 2 kV common mode voltage Mains power quality should be...

Страница 40: ...mended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency range b In...

Страница 41: ...nce according to frequency of transmitter in m Rated maximum output P of transmitter in watts 150 kHz to 80 MHz P d 17 1 80 MHz to 800 MHz P d 17 1 800 MHz to 2 5 GHz P d 33 2 0 01 0 12 0 12 0 23 0 1...

Страница 42: ...other sharps cannulas needles and scalpels in accordance with valid regulations disposal via germ proof and puncture proof containers When vaporizing tissue ensure that you do not inhale the combustio...

Страница 43: ...Instructions for Use Electrosurgical Unit ME 102 V 3 1 43...

Страница 44: ...Tuttlingen Germany Tel 49 74 61 16 58 80 verwaltung stuckenbrock de Martin Nederland Marned B V 1270 AG Huizen The Netherlands Tel 31 35 523 45 38 nederland klsmartin com Gebr der Martin GmbH Co KG Re...

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