KLS Martin Electrosurgical Units ME 400 and ME 200 Operating Instructions and Technical Data V 2.1-EN (02.10) Kts martin GROUPKus marti KLS Martin ME 400 and ME 200 Operating Instructions Inhaltsverzeichnis 1 Notes on product liability.. 14 2 Technical Data .. 4 24 Crest-Factor: 4 2.2 HF output... 5 2.3 HF output: Micro 5 2.4 Certificates... 15 3 Technical Description .. 6 4 Entry inspection 7 5 Safety points ... 7 5.1 Cardiac pacemakers .. 9 5.2 Important measures during intracardial operations. 9 5.3 Maintenance and repair 10 5.4 Care and sterilisation of accessories . 5.5 Cleaning and disinfection .. 5.6 Caution when using footswitches ... 5.7 Transurethral prostatic resections (TUR) (KLS Martin ME 400) .. 5.8 Using two Electrosurgical Units on one Patient... 6 Connecting the unit to the mains. 6.1 Caution.. 6.2 Tone generator 7 Function of operation elements and indicator lights . 7A Function of the components mounted on the rear ..... 7.2 Explanation of the symbols printed on the front panel. 7.3 The different current types... 8 Setting up 9 Function test ... 10 Principle of HF surgery 11 Electrosurgical terminology. 11.1 Electrotomy - cutting .. 11.1.1 Notes on intensity for cutting. 11.2 Coagulation. 11.2.1 Notes on the intensity for coagulation ME 400. 11.2.2 Notes on the intensity for coagulation ME 20Kts martin HOUr KLS Martin ME 400 and ME 200 Operating Instructions 11.3 11.4 11.5 11.5.1 12 13 14 15 16 17 17.1 17.2 17.3 18 Spray coagulation or fulguration . Bi-coagulation ... The KLS Martin automatic switch-on Notes on bi-coagulation technique: Diagrams ME 400 Diagrams ME 200.. Periodic safety checks.... Guarantee... The KLS Martin URO-CUT circuit (ME 400)... Ecological Information .. Packins Ecological Aspects of Operation.. Disposal of the Unit..... Accessories... v2.4Kts martin KLS Martin ME 400 and ME 200 Operating Instructions 1 Notes on product liability Gebriider Martin only accepts responsibility for the safety, reliability and performance of the units when: 1) Expansion of the installation, adjustments, modifications or repairs are carried out by a person authorised by Gebriider Martin 2) The electrical installations in the OR comply with IEC regulations 3) The unit is operated according to the instructions given 2 Technical Data Unit type ME 400 ME 200 Power requirement [V~] 220 - 240 220 - 240 110 - 120 110 - 120 Current consumption max. [VA] 780 380 Mains frequency [Hz] 50 - 60 50 - 60 Classification I I Type CF/Defibrillation | CF/Defibrillation protected protected HF nominal frequency [kHz] 480 480 Impulse frequency of modulation [kHz] 30 30 Mode of operation 10s/30s 10s/30s External accessible fuses 220 - 240 V~ 110 - 120 v~ 4.0 A slow blow 8.0 A slow blow 3.15 A slow blow 6.3 Aslow blow 22 Crest-Factot CURRENT TYPE IN OHMS ME 400 ME 200 ‘SPRAY-COAGULATION 500 8,0 8,0 CONTACT-COAGULATION 300 5,0 5,0 curr 500 1,5 15 CUT 500 2,2 2,2 CUT II 500 3,0 2,6 CUT IV 500 4,3 3,0 The crest factor is the ratio of peak power to r.m.s. power. V2.4KLS Martin ME 400 and ME 200 Operating Instructions Kis martin 2.2 HF output ME 400 ME 200 CURRENT TYPE IN OHMS WATTS WATTS SPRAY-COAGULATION 500 100 100 CONTACT-COAGULATION 300 250 175 cUTI 500 330 175 cUT II 500 300 175 CUT IIT 500 300 175 CUT IV 500 270 175 BIPOLARE COAGULATION 100 70 70 2.3 HF output: Micro (can be selected by pressing the “micro” touch-button) ME 400 ME 200, CURRENT TYPE IN OHMS. WATTS WATTS ‘SPRAY-COAGULATION 500 35 35 CONTACT-COAGULATION 300 80 60 cur 500 110 60 curt 500 100 60 cur 500 100 60 cUTIV 500 90 60 BIPOLARE COAGULATION 100 20 20 ME 400 ME 200 Weight [kg] 11,6 96 Dimensions height mm 135 135 width mm. 405 405 depth mm 380 380 Construction: Entire construction according to VDE 0750 Part 1/05.82 (=IEC 601-1/1977) and VDE 0750 Part 202/09.84 (=IEC 601-2-2) 2.4 Certificates C € 0297 confirm with 93 / 42 / EEC v2aKts martin KLS Martin ME 400 and ME 200 Operating Instructions 3 Technical Description The KLS Martin ME 400 and ME 200 electrosurgical units are constructed using the most mod- ern components of power electronics and the latest safety technology according to VDE 0750 and DIN IEC 601. The current supply to the circuits and the power output stage comes from a switch-mode pow- er supply. Due to this, the set values are not influenced by voltage fluctuations in the mains. The KLS Martin ME 400 and ME 200 electrosurgical units display the following features: + The Free Running Oscillator generators of the KLS Martin ME 400 and ME 200 meet the high requirements of the operating theatre. Operating safety is increased by automatic power shut-off in the event of malfunction. + No openings or cooling ribs, no fans. Due to the efficiency of the generators there is a mi- nimal drop in output. + Simple operation due clearly-arranged controls with easy-to-understand symbols. Addition- al digital display of the set dose. + Four different current types for cutting: choice of four settings from smooth cutting to cut ting with heavy scab formation. + Two current types for coagulation: choice of high power for contact coagulation and a cur- rent with a high crest factor for spray coagulation. + Aseparate generator with automatic start-up for bipolar coagulation. The bicoagulation generator can be used simultaneously with the generator for cutting / coagulation. + Combined sockets for KLS Martin coaxial cables and for disposables. + All connections for active electrodes, neutral electrodes and for the footswitch on the front panel. + The integrated KLS Martin Patient Control System (PCS), when used with a PCS neutral electrode, carries out constant application monitoring. + Visual and acoustic signs of HF activation by different coloured indicators and different acoustic tones for cutting and coagulation. + Infinitely variable output power for all seven current types. + Safety feature in the event of malfunction. + Acoustic warning feature in high frequency activation > 15 sec. (switch-on-time). + KLS Martin URO-CUT circuit for endoscopy and TUR (only for the KLS Martin ME 400). + The micro function enables power to be adjusted for difficult applications. 6 vadKis martin KLS Martin ME 400 and ME 200 Operating Instructions 4 Entry inspection Kindly check units and accessories for damages caused during transport or shortcomings. Damage claims may only be considered if the seller or carrier is immediately advised. After this, a report on the damage must be compiled. This report must be sent to the nearest KLS Martin representative or to Gebriider Martin headquarters so that the insurance company can be advised. If a unit has be sent back to Gebriider Martin or to a KLS Martin service point, it should be in the original box if possible. The following details must be enclosed: Name and address of proprietor, type and serial number of the unit, description of defect. 5 Safety points Only use approved and properly-functioning accessories. Defective accessories should be re- jected. Appropriate preoperational checks should be carried out. CAUTION Before attaching the neutral electrode, the following points concerning the positioning of the patient should be noted: For high frequency, the patient including his extremities must be insulated against earthed metal parts of the operating table, Elastic surfaces on operating tables are slightly conductive for draining electric charges. Thus they are not always suitable for simultaneously guaranteeing the required HF insulation for patients against metal parts. This insulation from high frequency may be achieved by using a sufficient number of additional layers in-between (sterile towels). If moisture or perspiration is expected during the operation, a waterproof foil must be used to prevent this from seeping through the layers which serve to insulate from high frequency. Absorbent towels must placed between the patient and the foil to avoid liquid accumulation under the patient. Areas of extreme perspiration, on extremities of the body connected to the trunk or skin-to- skin contact areas should be kept dry by placing towels in-between (arm-trunk, leg-leg, mamma). acrve elecvode > Nesta! eecroge Place dry, absorbent towels in-between. v2.4kus mar tin KLS Martin ME 400 and ME 200 Operating Instructions Attach electrodes and cables carefully. Pay particular attention to the following: * The neutral electrode must be as near as possible to the operating area. + The secure contact of the neutral electrode must be guaranteed for the entire duration of the use of high frequency; when placing the neutral electrodes at the extremities, blood circulation must not be affected. + The cables to HF electrodes should be arranged without loops so that they touch neither the patient nor the other cables. This especially holds true for the neutral electrode. Only cables intended for use with the unit as designated by the manufacturer should be used. * Keep the current path in the body as short as possible and in a longitudinal or diagonal direction of the body. It should not transverse the body, particularly not at the thorax. Re- move, insulate or pay particular attention to metal parts in and around the body. + When using HF surgical and patient monitoring units simultaneously in a patient, only use monitoring electrodes whose cables either have protective resistors or HF chokes. Needle electrode monitoring should not be carried out. The active electrosurgical electrode must not be used near ECG electrodes (minimum distance 15 cm). The following rules should be adhered to when performing HF surgery: The high frequency current should be set as low as possible for the intended application. Note: Unsatisfactory effects with regular setting could be due to improper positioning of the neural electrode or poor contact in the sockets, broken wires under insulation or encrusted electrodes. This should be checked and possible defective components should be replaced. 8 v2aKis martin KLS Martin ME 400 and ME 200 Operating Instructions + When changing the position of the patient, ensure that electrodes and cables are correctly positioned. * In operations on parts of the body with a small diameter, the bipolar technique may be used to avoid unintentional coagulation at other points. ‘+ The use of flammable anaesthetics, laughing gas (NO2) and oxygen should be avoided. The use of HF surgical units is always associated with sparking at the active electrode. Flamma- ble substances used as cleaning or disinfecting agents or as solvents for adhesives must be evaporated before using the unit, There is the danger of flammable substances accumulat- ing under the patient or in the body cavites such as the navel or the vagina. Liquids which have accumulated at these points must be removed before the HF surgical unit is used. En- dogenous gases may explode. Oxygen-saturated materials such as cotton wool and gauzes may be ignited by sparks produced by the HF electrosurgical unit. ‘+ Combining these units with others should only be carried out by the manufacturer or with the approval of the manufacturer. ‘+ The operation of the HF electrosurgical unit may interfere with the operation of other elec- tromedical devices. 5.1 Cardiac pacemakers In patients with cardiac pacemakers or pacemaker electrodes, there is a danger of a distur- bance in pacemaker function or damage to the pacemaker occurring. If in doubt, consult the cardiology department for advice. Before treating outpatients, ask if the patient has a pace- maker. Monitoring should be carried out and a defibrillator at hand when using HF electrosur- gical units on patients with pacemakers. 5.2 Important measures during intracardial operations ‘+ Carry out a visual check to see if there is proper connection of equipotential cables between the mobile units (safety class I) and the earthing plug in the room. ‘* Carry out a visual check to see whether the coupling of several units together is correct. * Carry out a visual check to see whether the patient cables and the electrodes are properly connected to the unit. © Check function of all connected units without the patient (e.g. operating of calibration but- ton in ECG units). © Instruct theatre staff that any contact with parts capable of conducting to the heart should be avoided, e.g. transducer housings, metallic tube connections, valves, taps, guide wires, and electrode catheters, therefore: * Only touch conductive parts when wearing rubber gloves. * Keep parts conductively connected to the catheter insulated from earth potential, e.g. me- tallic injection syringes. v2.4 9Kts martin edited KLS Martin ME 400 and ME 200 Operating Instructions © If not fully insulated, fasten pressure transducers to a point where they are insulated from earth potential. After the catheter is connected, cover transducer with insulating foil (use rubber gloves). * Do not use metallic faucets if possible. ‘+ Have a defibrillator available for instant use and the instructions for its safe application, e.g. whether the patient cables and electrodes have to be separated from the unit (from the ground) before defibrillation. Do not touch the patient during defibrillation. Not See regulations for use of defibrillators, DIN 57 753 Part 3 / VDE 0753 Part 3. * Have a pacemaker ready. ‘When positioning the patient, please ensure that there is no electrical conduction between the patient and the earthed metal parts. This does not apply to the connection of the single neutral electrode. Disturbances in the network (mains hum) during intracardial investiga- tions in ECG may be an indicator of improper earthing of the units. Note: It is advisable to use insulated floating parts for all parts of the unit which come directly into contact with the heart. 5.3 Maintenance and repair The unit and accessories are not intended to be repaired or maintained by the user or his technical personal. Obvious defects, e.g. in the plugs and connecting cables, must be repaired as soon as possible. Repairs to the unit may only be carried out by us or by someone authorised by us. If repairs are carried out by someone authorised by us, the user of the unit is requested to obtain a cer- tificate describing the nature and extent of repair. This certificate must bear the date of repair as well as the company name and a signature. If the repairs are not carried out by the manu- facturer of the unit, repaired units and parts must bear the mark of the repairer. 10 V2.4Kits martin KLS Martin ME 400 and ME 200 Operating Instructions le 5.4 Care and sterilisation of accessories Well-cleaned active and neutral electrodes are essential for good operational results. All accessories must constantly be checked to see if they are functioning properly. Parts with faulty insulation must not be used. The following sterilisation temperatures are permitted: gas stream hot air sterilisation sterilisation sterilisation upto 70°C 120°C/134°C 200°C Electrode handles with cable + + : Active electrodes + + + Forceps for bipolar coagulation + + - Neutral electrodes (rubber) + +f : Note: Accessories marked as disposable accessories may not be sterilised and re-used (cf. section 18). infection 5.5 Cleaning and di The unit may be cleaned with the usual non-alcoholic cleaning agents on all exterior surfaces including the front panel. The unit and non-sterilisable accessories may be disinfected with the usual disinfection agents used in the theatre department, e.g. 3% —_Incidin Extra® Henkel KGaA 2% — Incidin perfekt® Henkel KGaA 2% — Incidur® Henkel KGaA 3% — Lysoformin 3000® © Rosemann GmbH 1% — Sirafan® Henkel KGaA 2% — Tegodor F® T. Goldschmidt AG Before the unit is used, residues of disinfection agents must be removed. V2a amKLs martin KLS Martin ME 400 and ME 200 Operating Instructions 5.6 Caution when using footswitches In the area described as the “medical zone’, only footswitches proven and described as “OP safe” may be used. Please see drawing below. 5.7 Transurethral prostatic resections (TUR) (KLS Martin ME 400) As is well-known, easily inflammable gases can be generated in the course of transurethral prostatic resections (TUR), particularly during uninterrupted or extended HF application. In such a case, the gases tend to accumulate in the upper region of the bladder. If ambient air mixes with those gases, the hazard is still greater, as an accidental explosion might be caused if the HF current comes in contact with the gas mixture. Therefore, see to it that the gas-air bubble inside the bladder is kept as small as possible. 5.8 Using two Electrosurgical Units on one Patient As a rule, the use of two electrosurgical units on one patient should be limited to cases where this is necessary for medical reasons, as such simultaneous operation poses an increased risk of unintended burns due to high-frequency leakage currents. The following rules should be observed when working with two electrosurgical units simulta neously + Be sure to use only type CF electrosurgical units from Gebrider Martin. + Every HF unit operated in monopolar mode requires a neutral electrode attached separately to the patient's skin. Be sure to comply with the instructions for correct NE attachment! + No neutral electrode is needed for purely bipolar operation of electrosurgical units. 12 vadKLs martin KLS Martin ME 400 and ME 200 Operating Instructions + Regarding the flow of current from the active electrode to the neutral electrode, the ex- pected current paths must not be allowed to cross or superimpose each other, Therefore, the respective neutral electrodes must be attached as close to the surgical site as possible. + The sum total of the simultaneously applied power outputs must not exceed 400 watts. 6 Connecting the unit to the mains The unit may only be electrically connected to an earthed socket installed according to regula- tions. Before switching the unit on for the first time, please ensure that the mains voltage given on the identification plate (fixed on the rear of the unit) correponds to your power supply voltage. The mains fuses is mounted at the rear of the unit. 6.1 Caution Disconnect the mains plug before opening the unit. 6.2 Tone generator When switching on the various HF generators, an acoustic signal is audible. Each generator has its own audio frequency. 13 v2.kts martin GROUP KLS Martin ME 400 and ME 200 Operating Instructions 7 Function of operation elements and indicator lights ? oe ® oP ® ® ¢ aaa eI | | : : noo 2 S| ® oe ae & aoe 8 ® ® manor | | ME|200 . +] wo co fey | @ | ® ne & rt - Se ®@ ® ® @ ; ° Power 7 oO