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3-6

WARNING

 

Make certain during high-frequency surgical operations that anesthetics, skin cleaning agents
and disinfectants are nonflammable. If their use is unavoidable, they must have completely
evaporated and the vapor must be removed from the area of spark formation before switching on
the high-frequency surgical unit.

Before application of high-frequency surgery in the gastro-intestinal tract, it must be ensured
that no flammable (endogenous) gases are present here. There is danger of explosion if flammable
gases are present. For this reason, these gases must be extracted and/or eliminated by flushing
out the affected lumen with 

CO

2

before using high-frequency surgery.

During transurethral resection (TUR), H

2

O molecules may dissociate into H

2

 and O

2

 in the arc

between the resection loop and the irrigation liquid. These gases may collect on the roof of the
urinary bladder as a highly explosive gas mixture. If resection is performed in this gas mixture,
dangerous explosions may occur.

3.1.9 Unintentional burns due to hot electrodes

Cutting and/or coagulation electrodes become hot during cutting and/or coagulation procedures
indirectly through the heated tissue and through the electric arc.

WARNING 

Tissue can be unintentionally burnt immediately after cutting and/or coagulation procedures if
electrodes that are still hot touch the tissue. Attention must be especially paid to this during
endoscopic operations, such as during pelviscopic fallopian tube coagulation or during endoscopic
polypectomy.

3.2

Electric shock

An electric shock may occur if the high-frequency surgical unit delivers a too heavy low-frequency
current or if a too heavy low-frequency current flows through the patient into the high-frequency
surgical unit from another voltage source.

3.3

Stimulation of nerves and muscles

A known risk of high-frequency surgery is the unintentional electric stimulation of the patient’s
nerves and muscles. This stimulation can result from low-frequency electrical currents that are
caused either by low-frequency current sources or due to electrical arcs between an active electrode
and the patient’s tissue.

Electric alternating current with a frequency above 300 kHz is unable to stimulate nerves and
muscles.

Summary of Contents for ERBOTOM ICC 350 M

Page 1: ...ERBOTOM ICC 350 Instruction manual 08 00 ERBE...

Page 2: ......

Page 3: ...16 10128 061 10128 300 10128 301 10128 025 10128 402 ERBOTOM ICC 350 Z V 2 X 10128 065 ERBOTOM ICC 350 T V 2 X 10128 066 ERBOTOM ICC 350 M V 4 X 10128 080 10128 083 ERBOTOM ICC 350 M DOKU V 4 X 10128...

Page 4: ...or processed reproduced or distributed by means of electronic systems without prior written permission from ERBE ELEKTROMEDIZIN GmbH The information contained in this instruction manual may be revised...

Page 5: ...s 3 6 3 4 Cardiac pacemaker 3 7 3 5 Danger of explosion 3 7 3 6 Interference with other electronic equipment 3 7 4 DESCRIPTION OF THE HIGH FREQUENCY SURGICAL UNIT 4 1 4 1 General description 4 1 4 2 D...

Page 6: ...c signals 9 5 9 3 Diagrams 9 6 10 INSTALLATION 10 1 11 CLEANING AND DISINFECTION OF THE UNIT 11 1 12 PERFORMANCE CHECKS 12 1 12 1 Automatic performance test after starting up the unit 12 1 12 2 Automa...

Page 7: ...truction manual Please read the instruction manual for the ICC 350 It applies to all versions of this high frequency surgical unit If you have an ICC 350 Z for example please additionally read the cha...

Page 8: ...1 2...

Page 9: ...e high frequency surgical unit to the extent permitted by the type of application intended Initial operation Before delivery every high frequency surgical unit is tested by the manufacturer in regard...

Page 10: ...2 2...

Page 11: ...ive objects during high frequency surgery The black elastic table covers on operating tables demonstrate a certain electrical conductivity for diverting electrical charges Therefore they are never sui...

Page 12: ...way that they can touch the patient directly or indirectly through electrically conductive objects or wet cloths The lines to the active electrodes should be positioned in such a way that they touch...

Page 13: ...this entire distance If the diameter of the tissue next to the application point of the coagulation electrode is smaller than at the point of application coagulation will also occur next to the appli...

Page 14: ...that only accessories in perfect condition are used for high frequency surgery Only accessories that are compatible or tested by the unit manufacturer must be used This applies both to the active ele...

Page 15: ...nd resulted in burns without being noticed 3 1 7 Unintentional thermal tissue damage due to output error The risk of unintentional thermal tissue damage is proportionate to the intensity and time limi...

Page 16: ...ns due to hot electrodes Cutting and or coagulation electrodes become hot during cutting and or coagulation procedures indirectly through the heated tissue and through the electric arc WARNING Tissue...

Page 17: ...ate sparks during operation on the active electrode For this reason it is necessary to make certain during interventions that anesthetics degreasers and disinfectants are neither flammable nor explosi...

Page 18: ...3 8...

Page 19: ...7 8 9 10 International Standard...

Page 20: ......

Page 21: ...UT HIGH CUT is especially suitable for cutting in tissue with poor electric conduction Since the HF voltage in the HIGH CUT mode can attain high values on the active electrode HIGH CUT should however...

Page 22: ...ction loops Spray coagulation The Spray coagulation mode on the ICC is also suitable for Argon Gas coagulation Adjustable power limitation in the various coagulation modes For the ERBOTOM ICC units th...

Page 23: ...the tissue uninterruptedly for at least as long as the respectively selected delay lasts If the contact is interrupted before the respectively selected period of delay is over the respective period of...

Page 24: ...ctivated This is advantageous if for example the power supply briefly fails If the unit was switched off for longer than approx 15 seconds the basic setting of the program used before switching off ap...

Page 25: ...nstant Activation of monopolar cutting can be done using either the yellow key on the electrode handle or the yellow pedal on the footswitch Activation is visually signaled by continuous illumination...

Page 26: ...rgon Plasma coagulation 3 5 Power limitation The HF power output can be limited in 1 watt steps from 120 watts to 1 watt If the display 3 6 shows the Auto Coag 1 mode is switched off 3 6 Display of th...

Page 27: ...he display 4 6 shows the Auto Coag 2 mode is switched off 4 6 Display of the set power limitation in max watt 4 7 Changeover switch for the blue pedal If the left signal 4 7 1 is illuminated in this k...

Page 28: ...ional contact of the coagulation instrument with tissue cannot be safely avoided here The AUTO START key has no function on the ICC 350 No 10128 025 n some countries the ICC units are supplied with th...

Page 29: ...can be custom defined and programmed by the user It is recommended that the corresponding basic settings be documented The use of programs is especially practical for special application areas or cut...

Page 30: ...for coagulation and cutting The parameters for bipolar cutting with a choice of coagulation effect are set via the AUTO CUT function field The parameters for bipolar coagulation are set via the AUTO...

Page 31: ...is the case for example for endoscopic polypectomy of larger polyps as well as for papillotomy In such cases the HF generator must provide higher than normal power so that the initial incision can pr...

Page 32: ...nding of the neutral electrode and the type CF appear to contradict one another The ICC 350 fulfills both specifications at the same time because it is equipped with a low frequency leakage current mo...

Page 33: ...surgical units of the ERBOTOM ICC series are equipped with various safety devices to protect the patients and users 12 Connecting socket for a dual pedal footswitch A dual pedal footswitch can be conn...

Page 34: ...set up the instrument in such a way that acoustic signals are easily heard from this speaker The volume of the acoustic signals is set at the factory 17 Power connection This high frequency surgical...

Page 35: ...tically The HF generator can only be activated once the cause of error has been eliminated In this way the ERBOTOM ICC 350 also fulfills the Type CF requirements in the Earth Referenced mode 4 3 Descr...

Page 36: ...current and generates a visible warning signal if the HF leakage exceeds 150 mAeff If the HF leakage current exceeds 300 mAeff the HF leakage monitor additionally produces an acoustic signal If the a...

Page 37: ...nder the operator during cutting and or coagulation Since the risk of thermal tissue damage varies greatly among the various operating modes the ICC can adapt and store the maximum time limit for each...

Page 38: ...ectrode on the patient Here the electric conductance between the two contact surfaces on the neutral electrode and the skin of the patient is constantly measured automatically and compared with the in...

Page 39: ...ges to which the current flows than at the distal corners or edges attention should always be paid during application of neutral electrodes that the current flows toward the long edge NESSY compares t...

Page 40: ...ontact surfaces 4 3 6 Protection against operating error To prevent operating errors the front panel is designed in such a way that illogical and or incomplete settings are automatically monitored and...

Page 41: ...a key on the electrode handle is shorted or bypassed at low resistance due to an error e g by moisture in the electrode handle or pressed while the power switch is switched on this error is signaled a...

Page 42: ...4 22...

Page 43: ...electrode handle for the Neurotest device electrode handles no 20190 027 20190 061 for the Neurotest device are equipped with a different plug than the electrode handles for high frequency surgery It...

Page 44: ...square of the distance r Consequently due to this physical condition a localization of motor nerves and or muscles is all the more precise the smaller the intensity of the current I is The implication...

Page 45: ...ould erroneously lead to the belief that no electrically stimulable tissue structures are present in the affected area For this reason the NEUROTEST device only produces acoustic signals beeps if the...

Page 46: ...y deactivated However the Neurotest device can be immediately reactivated after this 5 4 Technical data NEUROTEST device in the ERBOTOM ICC 350 T Pulse waveform square Pulse duration 0 33 ms Pause len...

Page 47: ...Connecting socket for the active Neurotest electrode on the front panel Electrode handles for cutting and coagulation are also connected to this socket 19 Connecting socket for remote adjustment of t...

Page 48: ...eases from the stimulation electrode i e inversely as the square of the distance r Consequently due to this physical condition a localization of motor nerves and or muscles is all the more precise the...

Page 49: ...nsity is automatically and constantly controlled within the practically expected resistance range Step 1 05 mA from 0 to 20 0 kOhm Step 2 10 mA from 0 to 10 0 kOhm Step 3 15 mA from 0 to 6 6 kOhm Step...

Page 50: ...an error in the electronic fuse hardware is determined this is indicated for a few seconds by error no 91 d The maximum activation time for the NEUROTEST device is automatically limited for reasons of...

Page 51: ...tional controls 19 Connecting socket for multifunctional MIC instruments and MIN instruments 20 Compressed air input from an external compressed air source As an external compressed air source a compr...

Page 52: ...ameters can be set AUTO COAG 2 The HF power output for SOFT can be limited in 1 watt steps from 120 watts to 1 watt For FORCED from 60 watts to 1 watt SPRAY is blocked Activation of AUTO STOP during S...

Page 53: ...ent is connected to the MIC socket 19 the IIS automatically checks which instrument it is and briefly displays the code number of the respective instrument Then the IIS calls up the program defined an...

Page 54: ...strument Settings e g for instrument 1 The limitations for other instruments are described in the respective Notes on use AUTO CUT The HF power output for cutting with the instrument can be limited in...

Page 55: ...n is via optical waveguide Installation 1 Connect the optical waveguide box to the COM1 interface of the computer using the 9 pin Sub D cable 2 Switch on the computer and the ICC 350 3 Connect the opt...

Page 56: ...he length of the optical waveguide cable is sufficient to connect the optical waveguide box to the ICC 350 M DOKU The computer and the plug in power supply unit for the optical waveguide box are suppl...

Page 57: ...u for the loaded incision F3 Activation readiness The PC is ready to receive incision data The ICC and the PC constantly check the incision location As soon as the connection is OK the message ICC con...

Page 58: ...F6 Display diagram spark measurement value ON or OFF The spark measurement value is between 0 and 100 F7 Display diagram energy ON or OFF Energy P t in Ws The total energy for the incision image is al...

Page 59: ...the electric arc automatically controlled Cutting quality 4 coagulation effects selectable by key Constancy of the 4 coagulation effects automatically controlled HF rated power 300 watts at RL 500 ohm...

Page 60: ...he HF voltage Version 2 max 2 300 Vp Peak value of the HF voltage Version 3 max 2 300 Vp Peak value of the HF voltage Version 4 max 2 600 Vp HF rated power 120 watts at RL 350 ohms HF power limitation...

Page 61: ...ctrical connection between the neutral electrode and high frequency surgical unit and b between the neutral electrode and patient c of the symmetry of the HF partial currents iHF1 iHF2 d of the HF cur...

Page 62: ...ax HF power 620 watts 920 VA Current consumption in Standby mode 150 mA at 230 240 V 300 mA at 100 115 V Potential equalization terminal yes Power fuses 2 slow burn 4 A at 230 240 V 8 A at 100 115 V C...

Page 63: ...pplied to patient or contact resistance between the contact surfaces and patient greater than 120 ohms red Error No 13 HF current relative to the contact resistance between the contact surfaces of a d...

Page 64: ...3 Diagrams AUTO CUT MODE Effect 1 2 3 4 BIPOLAR CUT MODE Peak value of the HF output voltage UHF at no load as a function of the power limitation Pmax for EFFECT 1 to 4 Power limitation in BIPOLAR CUT...

Page 65: ...9 7 HIGH CUT Effect 1 2 3 4 Peak value of the HF output voltage UHF at no load as a function of the power limitation Pmax for EFFECT 1 to 4...

Page 66: ...9 8 SOFT COAGULATION AUTO BIPOLAR Peak value of the HF output voltage UHF at no load as a function of the power limitation Pmax...

Page 67: ...9 9 FORCED COAGULATION For 4 not ICC 350 T Z Peak value of the HF output voltage UHF at no load as a function of the power limitation Pmax...

Page 68: ...9 10 SPRAY COAGULATION Peak value of the HF output voltage UHF at no load as a function of the power limitation Pmax...

Page 69: ...9 11 CUT MODE Effect 1 2 3 4 Power output as a function of load resistance for power limitation of 300 watts...

Page 70: ...9 12 CUT MODE Effect 1 2 3 4 Power output as a function of load resistance for power limitation of 150 watts...

Page 71: ...9 13 HIGH CUT Effect 1 2 3 4 Power output as a function of load resistance for power limitation of 300 watts...

Page 72: ...9 14 HIGH CUT Effect 1 2 3 4 Power output as a function of load resistance for power limitation of 150 watts...

Page 73: ...9 15 SOFT COAGULATION AUTO BIPOLAR Power output as a function of load resistance for 1 power limitation of 120 watts 2 power limitation of 60 watts...

Page 74: ...9 16 FORCED COAGULATION Power output as a function of load resistance for 1 power limitation of 120 watts 2 power limitation of 60 watts...

Page 75: ...9 17 SPRAY COAGULATION Power output as a function of load resistance for 1 power limitation of 120 watts 2 power limitation of 60 watts...

Page 76: ...9 18 BIPOLAR CUT MODE Power output as a function of load resistance for 1 power limitation of 100 watts 2 power limitation of 50 watts...

Page 77: ...9 19 AUTO CUT MODE Effect 1 2 3 4 Power output as a function of the power limitation RL 500 ohms...

Page 78: ...9 20 HIGH CUT Effect 1 2 3 4 Power output as a function of the power limitation RL 500 ohms...

Page 79: ...9 21 SOFT COAGULATION AUTO BIPOLAR Power output as a function of the power limitation RL 125 ohms...

Page 80: ...9 22 FORCED COAGULATION Power output as a function of the power limitation RL 350 ohms Forced 1 2 3 4...

Page 81: ...9 23 SPRAY COAGULATION Power output as a function of the power limitation RL 500 ohms...

Page 82: ...ll relative to R No warning signal B In this range IHF is too large relative to R The HF generator can be activated however a red warning signal and four warning tones are given after each activation...

Page 83: ...f their use is unavoidable these must be equipped with a protective ground in perfect working order The power outlet must be secured with a fuse with at least 10A rated current 10 4 Potential equaliza...

Page 84: ...Coagulation must also be precisely observed 10 10 Receiving inspection The unit should be checked immediately upon receipt for shipping damage and be subjected to a performance test In case of damage...

Page 85: ...e respective display the maximum time limit for each function field can be adjusted individually from 3 to 900 seconds 6 By pressing key 6 1 the set maximum time limits are stored The maximum time lim...

Page 86: ...ower limitation in the range of 1 watt to 80 watts Version 3 In this version the peak value of the voltage pulses increase continuously to 2 300 Vp as a function of the power limitation in the range o...

Page 87: ...he unit We recommend a spray or wipe down disinfection However the information from the disinfectant manufacturer absolutely must be observed here WARNING If cleaning or disinfection of the unit with...

Page 88: ...11 2...

Page 89: ...due to an error or depressed while the power switch is switched on this error is signaled acoustically after the power switch is switched on and displayed by an error number 3 If the contact of a foot...

Page 90: ...t 10 error numbers can be called up as follows via Test program number 2 at any time Calling up the stored error numbers via Test program 2 a Press key 3 while the unit is switched off and switch on t...

Page 91: ...onnection between the neutral electrode and unit Only for NESSY Version 3 Short between the two contact surfaces of a divided neutral electrode or in the cable to the neutral electrode Use a sufficien...

Page 92: ...he unit Please notify the Technical Service 30 The load resistance of the unit was too low Either the contact surface of the active electrode was too large or the power limitation set too low or there...

Page 93: ...till within tolerance limits 88 Maximum time limit exceeded Reactivate if necessary 89 The Neurotest is already activated when the unit is switched on Always switch on unit and activate after the auto...

Page 94: ...12 6...

Page 95: ...r electrical safety according to EN 60 601 1 Part 1 a Grounded conductor inspection b Leakage current inspection Performance test of all switches and control lamps on the unit Inspection of the monito...

Page 96: ...13 2...

Page 97: ...onal features have not been changed at the expense of safety DIN 57 751 1 VDE 0751 1 Changes and repairs to the unit in consideration of the special safety requirements for high frequency surgical uni...

Page 98: ...14 2...

Page 99: ...egard are only considered valid if the Seller or Shipping agent is immediately notified A damage report must be filled out The term of guarantee for the ICC is 1 year for accessory parts 6 months calc...

Page 100: ...15 2...

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