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Instructions for Use

Electrosurgical Unit Minicutter

Revision 08

Technical Data

Designation

Data electrosurgical unit Minicutter

Mains connection

100–240 V; 50/60 Hz

Power consumption

without HF output

approx. 16 VA

at max. output power

approx. 120 VA

Protection class

IP classification

IP2X

Classification acc. to German

Medical Devices Act

II b

Leakage currents NF/HF

acc. to IEC 60601-2-2

Type

BF; defibrillator-proof

Nominal frequency

460/920/1,230 kHz

Modulation frequency

58/77 kHz

Operating mode

Intermittent INT 10 s / 30 s corr. to 25 % duty factor

Mains fuses

T 1.6 AH, 250 V
G 5 x 20 mm

Signal level

HF display: 55 dB(A)
Alarm: 65 dB(A)

Weight

approx. 3.9 kg

Radio interference suppression Limit values according to DIN EN 55011 and DIN EN 60601-2-2

Radio interference immunity according to IEC 801

Dimensions W × H × D

270 x 120 x 250 mm

Environmental conditions for

transport and storage

Ambient temperature
Relative humidity
Air pressure

-25

°C to +70

°C (270 °F to 273 °F)

10–100%
500–1,060 hPa

Environmental conditions for

operation

Ambient temperature
Relative humidity
Air pressure

+10

°C to +40

°C (270 °F to 273 °F)

30–75%
700–1,060 hPa

Compliant with 93/42/EEC

Содержание Minicutter

Страница 1: ...Front Cover English Electrosurgical Unit Minicutter Instructions for Use 90 251 52 41 Revision 08 Date of Release 2021 02...

Страница 2: ...ocket 13 Connect foot switch to socket 13 Connect bipolar instrument to socket 14 Connect foot switch to socket 15 Select bipolar coag current button 9 Adjust output power Select cutting current Adjus...

Страница 3: ...e danger to life Follow Instructions for Use Catalog number Serial number Manufacturer Manufacturing date Non ionizing electromagnetic radiation CE conformity marking Warning Dangerous high voltage Cl...

Страница 4: ...ns and Displays 11 4 3 Mains Connection 12 4 4 Equipotential Bonding Connection 13 4 5 Switching On Off 13 4 6 Monopolar Operation 13 4 6 1 Connection of the Neutral Electrode 13 4 6 2 Connection of H...

Страница 5: ...h Other Devices 30 5 10 Risks from Accessory Equipment 30 5 11 Inadvertent emission of HF energy 30 5 12 Maintenance 30 6 Cleaning and Disinfection 31 7 Safety Check SC 32 8 Accessories 33 9 Technical...

Страница 6: ...operation of the unit as well as in its permissible combination with other medical devices objects and accessories This duly instructed officer shall subsequently be responsible for familiarizing the...

Страница 7: ...l invalidate any liability claims against Gebr der Martin 1 5 Inspection upon Receipt by User Immediately upon receipt the goods must be checked for completeness and potential damage in transit Notice...

Страница 8: ...both genders alike Reference to both genders is avoided purely for reasons of improved readability 2 1 Symbols Used in this Document In this document important information such as general or safety r...

Страница 9: ...urrent concentration is reduced during the further transport of the energy through the patient to the neutral electrode applied on a large area Therefore there is in accordance with its intended purpo...

Страница 10: ...ower output is adjusted via rotary knobs All connections for active electrodes neutral electrodes and foot switches are located on the front side Two current types for cutting Smooth cutting and cutti...

Страница 11: ...ion button for monopolar cutting 2 5 Activation LED for monopolar coagulation 6 Selection button for contact coagulation 7 Selection button for spray coagulation 8 Activation LED for bipolar coagulati...

Страница 12: ...classification of the device BF Unit is defibrillator proof Means WARNING PLEASE READ INSTRUCTIONS FOR USE WARNING HIGH FREQUENCY CURRENTS CAUTION HIGH VOLTAGE 4 3 Mains Connection Before initial swi...

Страница 13: ...5 Switching On Off After switching on the device using the mains switch 10 the unit is switched into operation mode After switching the unit on it is operational The surface of the rocker switch must...

Страница 14: ...sible 4 6 2 Connection of Handles For monopolar cutting or coagulation a handle with finger switch or a handle without finger switch in combination with a foot switch can be connected Handles are conn...

Страница 15: ...g In the operation panel Monopolar Coag that is marked blue on the front plate of the unit an indicator LED 5 indicates the activation of monopolar coagulation current and there are two current type a...

Страница 16: ...e angle of rotation the relation for each current type is indicated in the diagrams The specified power is always the maximum power that can be emitted to a nominal load In surgical applications the p...

Страница 17: ...the HF voltage transmitted to the instrument The HF current is delivered in accordance with the preset current types and the set power Pressing an activation button on the handle or foot switch activ...

Страница 18: ...F activation signal must be sounded Risk of malfunction danger of injury If the HF activation signal can be heard while no foot switch or handle is connected the device is faulty The device must not b...

Страница 19: ...e current type available for bipolar coagulation Bipolar coagulation Local contact coagulation in the area of the bipolar electrode pair 4 7 4 Bipolar Power Setting 1 2 3 4 5 6 7 8 9 10 Use the power...

Страница 20: ...functional check The neutral electrode does not have to be connected for bipolar operation As described in section 4 7 Bipolar Operation p 18 we recommend connecting the neutral electrodes even for bi...

Страница 21: ...important safety element It can be regulated on the rear of the unit but cannot be deactivated Immediately stop activation of the foot switch pedal The current type bipolar coagulation is deactivated...

Страница 22: ...the following The high frequency power should be set to the lowest possible setting for the respective application An insufficient effect while using the standard setting can for example be caused by...

Страница 23: ...k or skin on skin contact apart from each other and dry arm trunk leg leg breasts using insulating blankets Place the neutral electrode as close as possible to the operation field For operation fields...

Страница 24: ...r scarred tissue If necessary prepare the application site by cleaning and degreasing it strong hair growth is to be removed For removal do not use substances that desiccate the skin e g alcohol Dange...

Страница 25: ...clip of the neutral electrode risk of pressure necrosis Electrodes and cables must be applied carefully The supply cables to the high frequency electrodes must be laid out without loops and so that t...

Страница 26: ...cause neuromuscular stimulation in the patient Risk of electromagnetic interference with physiological monitoring devices When simultaneously using electrosurgery and monitors on the same patient use...

Страница 27: ...note If possible do not use flammable agents for cleaning or disinfection Combustible substances that are used for cleaning or disinfection or as solvents must be evaporated and removed by ventilatio...

Страница 28: ...to be observed In case of doubts qualified advice should be sought Contact of the active electrode with metallic parts implants endoprostheses etc during HF activation must be avoided Such patients a...

Страница 29: ...r accessories may lead to uncontrolled activation of the generator Unintentional HF activation during active function may also occur if the bipolar instrument is placed on the patient and thus comes i...

Страница 30: ...of injury from defective accessory equipment Using accessory equipment that is not in perfect working order defective or faulty can pose a hazard to patients or users and compromise the proper functio...

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

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

Страница 33: ...constitute a source of danger In case of doubt contact Gebr der Martin The accessory equipment must be suitable for at least the voltages indicated in section 9 Technical Data on page 34 Only accesso...

Страница 34: ...ncy 58 77 kHz Operating mode Intermittent INT 10 s 30 s corr to 25 duty factor Mains fuses T 1 6 AH 250 V G 5 x 20 mm Signal level HF display 55 dB A Alarm 65 dB A Weight approx 3 9 kg Radio interfere...

Страница 35: ...output voltage max 1 200 Vmax Max output current 510 mA at 300 Crest factor 2 1 Danger of injury from excessive voltage Active accessories to be used with this current must be able to withstand a com...

Страница 36: ...Instructions for Use Electrosurgical Unit Minicutter 36 Revision 08 Maximum and one half maximum output power HF output power in W Connection resistance in Setting 10 Setting 5...

Страница 37: ...0 Vmax Max output current 480 mA at 300 Crest factor 2 4 Danger of injury from excessive voltage Active accessories to be used with this current must be able to withstand a combination of an HF voltag...

Страница 38: ...Instructions for Use Electrosurgical Unit Minicutter 38 Revision 08 Maximum and one half maximum output power HF output power in W Connection resistance in Setting 10 Setting 5...

Страница 39: ...dic HF output voltage Max 1 300 Vmax Max output current 600 mA at 200 Crest factor 5 0 Danger of injury from excessive voltage Active accessories to be used with this current must be able to withstand...

Страница 40: ...Instructions for Use Electrosurgical Unit Minicutter 40 Revision 08 Maximum and one half maximum output power HF output power in W Connection resistance in Setting 10 Setting 5...

Страница 41: ...HF output voltage Max 2 000 Vmax Max output current 450 mA at 300 Crest factor 5 0 Danger of injury from excessive voltage Active accessories to be used with this current must be able to withstand an...

Страница 42: ...Instructions for Use Electrosurgical Unit Minicutter 42 Revision 08 Maximum and one half maximum output power HF output power in W Connection resistance in Setting 10 Setting 5...

Страница 43: ...ic HF output voltage Max 340 Vmax Max output current 1 200 mA at 50 Crest factor 2 5 Danger of injury from excessive voltage Active accessories to be used with this current must be able to withstand a...

Страница 44: ...Instructions for Use Electrosurgical Unit Minicutter 44 Revision 08 Maximum and one half maximum output power HF output power in W Connection resistance in Setting 10 Setting 5...

Страница 45: ...immunity of the device and in faulty operation In case of doubt contact Gebr der Martin Guidance and manufacturer s declaration Electromagnetic emission The electrosurgical unit Minicutter is intende...

Страница 46: ...oltage 1 kV differential mode voltage 2 kV common mode voltage The quality of the supply voltage should be that of a typical commercial or hospital environment Voltage dips short power interruptions a...

Страница 47: ...inity of equipment marked with the following symbol HF radiated disturbances according to IEC 61000 4 3 3 V m 80 MHz to 2 7 GHz 3 V m 80 MHz to 2 7 GHz Note These guidelines may not apply in all situa...

Страница 48: ...704 787 710 745 780 Pulsea 217 Hz 9 800 960 810 870 930 Pulsea 18 Hz 28 1700 1990 1720 1845 1970 Pulsea 217 Hz 28 2400 2570 2450 Pulsea 217 Hz 28 5100 5800 5240 5500 5785 Pulsea 217 Hz 9 Note A minimu...

Страница 49: ...lpels in accordance with valid regulations disposal via microbiologically tight and puncture proof containers When vaporizing tissue ensure that you do not inhale the combustion fumes that form by des...

Страница 50: ...Instructions for Use Electrosurgical Unit Minicutter 50 Revision 08...

Страница 51: ...Instructions for Use Electrosurgical Unit Minicutter Revision 08 51...

Страница 52: ...martin com Gebr der Martin GmbH Co KG Moscow Russia Phone 7 499 792 76 19 russia klsmartin com Gebr der Martin GmbH Co KG Dubai United Arab Emirates Phone 971 4 454 16 55 middleeast klsmartin com KLS...

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