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VIO 300 D

1. AUTO CUT R 500 Ohm 350 300 250 Effect 6 8 E e ffect5 200 Effect4 M Effect3 r 150 3 100 e Effect a 50 0 0 100 200 300 400 Power HF max W Fig 7 1 AUTO CUT 350 300 e Fffect8 ffect7 250 Effect6 200 em Fffect5 5 Effect4 8 150 Effect3 di e Effect2 feci 50 Pmax 150W 0 100 1000 10000 Resistance Ohm Fig 7 2 80104 521 06 2009 7 Monopolar Standard Modes 80104 521 06 2009 AUTO CUT 800 700 e ffect8 600 Etffeci7 500 F ffect6 rfect5 Es 400 Effect4 gt 300 Effect3 e Effect2 200 ffect1 100 0 0 50 100 150 200 250 300 350 Power HF max W Fig 7 3 HIGH CUT amm e Properties Reproducible tissue sparing cuts in particular in poorly conductive and varying tis sue PPS Power Peak System The HIGH CUT mode is equipped with PPS A special problem during incision may be posed by the initial incision phase in particular when the cutting electrode is pressed firmly against the tissue to be cut before activation of the HF generator so that the cutting electrode has a relatively extensive and thus low resistance contact with the tissue This is generally the case for example with TUR and endoscopic polypectomy In such cases the HF generator must offer an above average output so that the initial incis
2. TWIN COAG R 500 Ohm 250 e Effecta 200 F ffect7 emm Effect X 150 Effect5 E Effect4 T Effect3 e Effect2 Fffect 50 0 0 100 200 Power HF max W Fig 13 1 TWIN COAG 250 e Effect8 200 m ffect7 e Fffecto S 150 Effect5 D Effect4 gt e 100 Effect3 e Effect2 di m ffect1 a Pmax 100W 0 10 100 1000 10000 Resistance Ohm Fig 13 2 80104 521 06 2009 13 e APC Optional Modes Only Available with an APC Module 80104 521 06 2009 TWIN COAG 2500 2000 em ffect8 e tfoct7 P e Effecto a 1500 2 ffect5 T Effect4 gt 1000 Effect3 e feci 500 m Effect 0 0 50 100 150 200 250 Power W Fig 13 3 143 166 13 APC Optional Modes Only Available with an APC Module 144 166 80104 521 06 2009 80104 521 06 2009 14 Installation CHAPTER 14 Installation Ambient conditions Ignition of anesthetics skin cleansers and disinfectants in potentially explosive atmospheres If you place the device in a potentially explosive atmosphere anes thetics skin cleansers and disinfectants can ignite Risk of fire and explosion to the patient and medical personnel Risk of damage to property Do not place the device in potentially explosive atmospheres Interference with the unit by portable and mobile HF communi cation devices
3. DRY CUT 1800 1600 ume 4400 Effect8 m ffect7 ere 1000 Effects 2 Effect3 600 e Effect2 400 Effect 200 0 0 50 100 150 200 250 Power W Fig 12 19 Argon assisted SWIFT COAG Mode o n o o 5 a gt o o Fast effective coagulation which is highly suitable for preparation with high hemo stasis owing to its limited tissue cutting property Coagulation and preparation Ball electrodes only for coagulation Knife or blade electrodes for preparation and coagulation Note When using the ERBE VIO APC handpiece a conventional 4 mm electrode can be used instead of the argon applicator For this the flow setting must be set to 0 HF voltage waveform Rated frequency Crest factor Rated load resistor Max HF peak voltage Number of effects Constancy of effects HF power limitation Max power output at rated load resis tor pulse modulated sinusoidal alternat ing voltage 350 KHz at Ry 500 ohms 10 5 4 at Ry 500 ohms 500 ohms 2500 Vp 8 automatic control of HF peak voltage 5 watts to 200 watts in 1 watt steps 200 watts 20 80104 521 06 2009 12 APC Standard Modes Only Available with an APC Module 80104 521 06 2009 Diagrams SWIFT COAG R 500 Ohm 250 _ 200 e Effect 7 8 z e E ffect6 5 ffect5 B Effect
4. eene 22 Notes e yazli as adi i uie rmi 23 2 Safety Features lie 25 NESSY eunte lk as e E i lle leto eiie 25 How do I receive information about the safety status of the return electrode 26 Automatic monitoring of equipment output erro r i 29 Automatic monitoring of the ON time ceeeneceecesecneeeseeeeeeseeeseeaeeeees 29 Protection from operating errors e ee 30 do Accessories diners asinis uinea Dues adam i e TS ERIS Ec IERI CU MEE 31 Check compatibility of instrument and CUT COAG mode with the help of the Upmax display sesi alarm ed ernia 31 Check compatibility of the return electrode eee 33 4 Description of the Controls eeeeeeeeeeeeeeeeeeeee 35 Controls on the front panel ener 35 Controls on the Dack ayi e Bade e t eee tee etat tede 37 5 Working with the Electrosurgical Unit a Tutorial 39 The tutorial and your electrosurgical system seen 39 Make power connection switch on unit self test assignment of active program sada keke e arietes eer alama DU ates Eee exte gidenle Fase all 39 Adopt Program tette rete rade e ee alk Gla eee 42 Select Program edet e p eq e edi et te a Re pha 42 5 1166 Table of Contents 6 166 The basic concept of the electrosurgical unit focusing attention on the functions of a receptacle Focus VieW
5. ii 44 Changing settings of the Basic Program e 44 Setting Cut mmode uasa nene lana asly al nennt ane a 45 Setting CUT effectis arri en e o ea pee pe Pee 46 Selecting CUT Max Watta geisiant aiarra 47 Select COAG mode COAG effectandCOAGpowerlimitation 48 Activation of CUT and COAG modes with footswitch esses 48 Activation of CUT and COAG modes with fingerswitch Auto Start 50 The Focus View and activation concept of the electrosurgical unit What pointsamust T observe ose e tee eti HERR 51 NESS deca H MER 51 How do I receive information about the safety status of the return electrode 52 Saving the amended Basic program under a new name sese 56 Overwriting a program 2 eerte dete eei lla 57 Creating all settings for a program from scratch 58 Deleting a Programi asi netter tnter petet de e e Mists etx 58 Creating programs for ReMode function sse 58 Calling up Setup alal io ertet etsi e yl nues 62 Description of receptaclehardware 65 Purchasing further receptacles iui ia 65 Receptacles for different modesandinstrumentconnectors 65 Monopolar receptacle 5 ctr e rtt et teens 65 Bipolar receptacles 2 op etd Wii eatin oR el adele Hed eee 67 Multifunctional receptacle i 68 Receptacl
6. If you are alternating between two programs a and b the unit always calls up pro gram a after switch on even if you switched off with program b Fig 5 27 Fig 5 28 80104 521 06 2009 5 e Working with the Electrosurgical Unit a Tutorial 80104 521 06 2009 Examples of options for ReMode function Create programs 3a ReMode and 3b ReMode to familarize yourself with the first ReMode option Ist option You can switch between any two settings of a receptacle as required 2nd option You can switch between the settings of two receptacles for example if you assign the footswitch in program a to a monopolar receptacle and in program b to a bipolar receptacle If you start with program a and the monopolar receptacle and then switch to program b the settings for the monopolar receptacle will now still be displayed for program b but the footswitch is on the bipolar receptacle This recep tacle is configured with the settings you made for program b If you press the foot switch the display switches to the settings of the bipolar receptacle and BIPOLAR CUT or BIPOLAR COAG is activated This sounds rather complicated but just try out the two options according to the fol lowing instructions If you try out the ReMode function on the unit itself it will be come clearer O Basic program b cues Monopolar 4 PE receptacle Mode Mode gt AUTOCUT SPRAY COAG E Effect Fig 5 29 1 Call up the Basic Program Call
7. Unsuitable temperature or level of humidity during operation If you operate the equipment at an unsuitable temperature or level of humidity it may sustain damage fail or not perform properly Operate the equipment at a suitable temperature and level of hu midity You will find the tolerances for temperature and humid ity in the Technical Data If other ambient conditions must be observed for operation of the equipment you will also find them in the Technical Data Unsuitable temperature or humidity in transit or storage If you transport or store the equipment at an unsuitable temperature or level of humidity it may sustain damage and fail Transport and store the equipment at a suitable temperature and level of humidity You will find the tolerances for temperature and humidity in the Technical Data If other ambient conditions must be observed for transport and storage of the equipment you will also find them in the Techni cal Data Insufficient acclimatization time unsuitable temperature dur ing acclimatization If the device was stored or transported below or above a certain temperature it will take a certain time and temperature to acclima tize If you do not observe the rules the device can sustain damage and fail Acclimatize the device according to the rules in the Technical Data 11 166 1 Safety Instructions 12 166 Overheating of the device due to poor ventilation If ventil
8. 500 ohms Rated load resistor 500 ohms Max HF peak voltage 1550 Vp Number of effects 8 Constancy of effects automatic control of HF peak voltage 80104 521 06 2009 12 APC Standard Modes Only Available with an APC Module 80104 521 06 2009 HF power limitation 5 watts to 200 watts in 1 watt steps Max power output at rated load resis 200 watts 20 tor Diagrams SWIFT COAG R 500 Ohm 250 e ffect8 ffect7 200 ec F ffect6 5 Efect5 8 150 Efect4 i Effect3 T 100 Effect Effect o EE 0 0 100 200 Power HF max W Fig 12 23 SWIFT COAG 250 e ffect8 200 E ffect7 e ffect6 z 150 mu ffect5 5 Effect4 3 e 100 Effect3 e Effect2 m ffect1 a P max 100W 0 10 100 1000 10000 Resistance Ohm Fig 12 24 135 166 12 APC Standard Modes Only Available with an APC Module Properties Areas of use Difference from SWIFT COAG 136 166 Suitable electrodes Technical data SWIFT COAG 1800 1600 em rffect8 1400 ffect7 e E 1000 Effect5 2 Effect3 600 feci 400 fect 200 0 0 50 100 150 200 250 Power W Fig 12 25 Argon assisted FORCED COAG Mode Effective fast standard coagulation Contact coagulation clamp coagulation e g via insulated monop
9. 500 ohms 2000 Vp 8 automatic control of HF peak voltage 5 watts to 200 watts in 1 watt steps Max power output at rated load resis 200 watts 20 tor 5 3 3 TWIN COAG R 500 Ohm 250 em Effect8 200 Effect E ffect6 x 150 e Fffect5 E Effect4 Effect3 g 100 e Effect2 Ts E ffoct1 50 0 0 100 200 Power HF max W Fig 9 9 06 2009 9 Monopolar Optional Modes 80104 521 06 2009 TWIN COAG 250 e ffect8 200 F ffect7 F ffect6 150 E ffect5 5 Effect4 3 E 100 Effect3 e Effect2 di e Effect a Pmax 100W 0 10 100 1000 10000 Resistance Ohm Fig 9 10 TWIN COAG 2500 2000 em ffect8 ffect7 e ffect6 amp 1500 gt e ffect5 E Effect4 gt 1000 Effect3 e E ffect2 500 Effect 0 0 50 100 150 200 250 Power W Fig 9 11 109 166 9 Monopolar Optional Modes 110 166 80104 521 06 2009 80104 521 06 2009 10 Bipolar Optional Modes CHAPTER 10 Bipolar Optional Modes BiClamp Properties Special COAG mode for ERBE BiClamp bipolar clamp With four effect gradu ations you can adjust the coagulation performance exactly to the type of tissue in volved The AUTO STOP function is adjusted to BiClamp and ends activation au tomatically when the
10. Rated load resistor 50 ohms 80104 521 06 2009 12 APC Standard Modes Only Available with an APC Module 80104 521 06 2009 Max HF peak voltage 190 Vp Number of effects 8 Constancy of effects automatic control of HF peak voltage HF power limitation 5 watts to 200 watts in 1 watt steps Max power output at rated load resis 200 watts 20 tor Diagrams SOFT COAG R 50 Ohm 250 e ffect8 200 ffect7 m Effect6 g 150 E ffect5 Effect4 T 100 Effect3 Effect o n 50 ffect1 0 0 100 200 Power HF max W Fig 12 29 SOFT COAG 250 e ffect8 200 Effect7 ffect6 150 emm ffect5 o Effect4 gt e Effect2 50 ffect1 a Pmax 100W 0 10 100 1000 10000 Resistance Ohm Fig 12 30 139 166 12 APC Standard Modes Only Available with an APC Module 140 166 SOFT COAG 250 200 F ffect8 ffect7 De e Effecto a 150 gt e ffecto La Effect4 gt 100 Effect3 e feci 50 ffect1 0 0 50 100 150 200 250 Power W Fig 12 31 80104 521 06 2009 80104 521 06 2009 13 e APC Optional Modes Only Available with an APC Module CHAPTER 13 APC Optional Modes Only Available with an APC Module Argon assisted TWIN COAG Mode mo o Properties Fast effective coagulation which is highl
11. 18 Patient plates Single surface or dual surface patient plate connected Green all OK Red Hazard call up Focus button check patient plate 20 The symbol designates a constructional safety measure The patient circuit is insu lated from ground The danger of leakage currents and therefore the danger of burns is substantially reduced for the patient 21 The equipment conforms to the requirements of Type CF Cardiac Float and is pro tected against the effects of a defibrillator discharge 0 Basic program O gt eae Monopolar EL S 0 receptacle Mode Mode DRYCUT eee 4 Effect b 4 Ls E o max watts O 180 0 Fig 4 2 The buttons have a different function depending on which window is shown on the display Take note of the function toward which the button points In this example showing the Cut Coag settings for the monopolar receptacle the buttons have the following functions 2 Directory Programs Calls up the Directory window The window provides information about the assign ment of the active program Which CUT COAG mode which effect what capacity are active for which receptacle In addition you have access to the submenu Select Program and the submenu Ad ditional Functions 3 Select CUT mode Calls up the window for selection of a CUT mode 4 Select CUT effect Calls up the window for selection of a CUT effect 80104 521 06 2009 80104 521 06
12. Operation of the unit has been designed to be intuitive and enjoyable The time required to work through the tutorial and several separate exercises is between 30 and 45 minutes You should then have a grasp of all major functions Make power connection switch on unit self test assignment of active program 1 Make power connection The supply voltage must match the voltage specified on the unit s rating plate Connect the unit to a properly installed grounded outlet Only use the ERBE power cord or an equivalent power cord for this purpose The power cord must bear the na tional test symbol If the unit is installed on the VIO CART make the power con nection with the power cord of the VIO CART 2 Switch on unit performance Use the power switch to switch the unit on The unit then carries out a performance test test and checks all receptacles Connected units and footswitches are detected All pilot lamps and Focus buttons light up The version number of the software appears on the display 39 166 5 e Working with the Electrosurgical Unit a Tutorial 3 Getting an overview assign ment of the active program for 40 166 the electrosurgical unit Guide 1 program xy 3 Adopt Bipolar receptacle 4 program BIP CUT BISOFT 4 60W 4 60W Select Monop receptacle program DRY end lt 4 180W end 80W O 300 D MF 7 E ED loss Bo gt E lt 4 Fig 5 1 Once the performance test has been completed you will see the wi
13. ReMode gt Overwrite 4 Level two of prog no 3 gt ReMode Create lt A Ret Save as gt eturn new program Fig 5 33 8 You will then move to the window Save Press the selection button next to the menu item Level two of prog no 3 ReMode create 60 166 80104 521 06 2009 5 e Working with the Electrosurgical Unit a Tutorial 80104 521 06 2009 Switch between program 3a ReMode and 3b ReMode Amend program 3b ReMode to familarize yourself with the sec ond ReMode option gt eMode Name lt gt EE mico b Password No Return q Fig 5 34 9 You will then move to the window Save as Press the Enter button The program will be saved da ReMode 3h ReMode AMORI Monopolar SERE Monopolar Regs receptacle receptacle Modo Mode i Moda AUTO CUT SPRAY COAG DRY CUT FORCED COAG Effect Effect 100 1 10 max watts Fig 5 35 The system has renamed program 3 ReMode as 3a ReMode and saved a program 3b ReMode With the ReMode switch you can now switch between programs 3a ReMode and 3b ReMode The settings of the monopolar receptacle are always displayed With the footswitch only these settings can be activated as in both 3a ReMode and 3b ReMode the footswitch is allocated to the monopolar receptacle 1 In the program 3b ReMode call up the bipolar receptacle 2 Assign the footswitch CUT and COAG to the bipolar receptacle Any value can be set for the bipolar receptacle 3
14. cuts in open surgery and cuts in endoscopic operations that require very good primary hemostasis during the cut and tolerate a somewhat slower cutting speed APC applicators with adjustable electrodes as well as the laparoscopic hook elec trode HF voltage waveform Rated frequency Crest factor Rated load resistor Max HF peak voltage Number of effects Constancy of effects HF power limitation Max power output at rated load resis tor pulse modulated sinusoidal alternat ing voltage 350 kHz at Ry 500 ohms 10 3 5 at R 500 ohms 500 ohms 1 550 Vp 8 automatic control of HF peak voltage 10 watts to 200 watts in 1 watt steps 200 watts 20 80104 521 06 2009 12 APC Standard Modes Only Available with an APC Module 80104 521 06 2009 Diagrams DRY CUT R 500 Ohm 250 200 ffect8 Efeci7 5 em Effecto amp 150 5 e ffecto E Effect X 100 Effect3 3 e Effect 50 Effect 0 0 100 200 Power HF max W Fig 12 17 DRY CUT 250 e Effecta 200 ffect7 ffect6 150 Fffect5 Effect4 100 Effect3 e Effect2 ffect1 50 bp max 100W Power W 10 100 1000 10000 Resistance Ohm Fig 12 18 131 166 12 APC Standard Modes Only Available with an APC Module 132 166 Properties Areas of use Suitable electrodes Technical data
15. 0 0 100 200 300 400 Power HF max W Fig 7 4 HIGH CUT 350 300 e Effecta foct7 250 Eftect6 200 ffect5 5 gt Effect4 150 Effect3 406 e Effect2 Effect 50 eee Pmax 150W 0 100 1000 10000 Resistance Ohm Fig 7 5 80104 521 06 2009 7 Monopolar Standard Modes HIGH CUT 800 700 e Effect8 600 e Ef oct7 500 e Effecto EJ PEffect5 E 490 Effect4 2 300 Effect3 de 200 Effect2 e Effect 100 0 0 50 100 150 200 250 300 350 Power W Fig 7 6 DRY CUT 80104 521 06 2009 Properties Intense haemostasis with somewhat slower cutting speed Areas of use E g cuts in open surgery and cuts in endoscopic operations that require very good primary hemostasis during the cut and tolerate a somewhat slower cutting speed Difference from AUTO CUT and HIGH CUT Medium to intense hemostasis Suitable electrodes Electrodes with a large application area knife and spatula electrodes and strap loop electrodes Technical data HF voltage waveform Rated frequency Crest factor Rated load resistor Max HF peak voltage Number of effects Constancy of effects HF power limitation Max power output at rated load resis tor pulse modulated sinusoidal alternat ing voltage 350 kHz at Ry 500 ohms 10 effect 1 4 3 0 effect 5 6 3 2 effect 748 3 8 at R 500 ohms 500 ohms 1450 Vp 8 automatic control of HF pe
16. 80 100 120 140 Power W Fig 12 7 Argon assisted AUTO CUT Mode Reproducible extremely tissue sparing cuts minimal to medium hemostasis The argon gas reduces the formation of smoke and the carbonization All cutting procedures in electrically conductive tissue e g muscle tissue and vas cular tissue Dissections and cutting of fine structures APC applicators with adjustable electrodes as well as the laparoscopic hook elec trode HF voltage waveform Rated frequency Crest factor unmodulated sinusoidal alternating voltage 350 kHz at RL 500 ohms 10 1 4 at RL 500 ohms Rated load resistor 500 ohms Max HF peak voltage 740 Vp Number of effects 8 Constancy of effects HF power limitation Max power output at rated load resis tor automatic control of HF peak voltage 10 watts to 300 watts in 1 watt steps 300 watts 20 80104 521 06 2009 12 APC Standard Modes Only Available with an APC Module 80104 521 06 2009 Diagrams AUTO CUT R 500 Ohm 350 300 250 e Effect 6 8 E e fect5 200 Fffect4 Effect3 zr 150 5 e Fffect2 3 100 F ffect1 a 50 0 0 100 200 300 400 Power HF max W Fig 12 8 AUTO CUT 350 300 e E ffect8 ffect7 230 e Effect F ffect5 200 o gt Effect4 150 Effects 100 e Effect2 e ffect1 50 emm Pmax 150W 0
17. If the unit is set for a single surface electrode and you connect a dual surface electrode the single indicator light will illuminate red In both cases you can only activate monopolar mode if you connect the correct electrode If you switch on the unit without having connected an electrode the indicator lights will illuminate red It is not possible to activate monopolar mode If you connect a single surface electrode the unit only monitors the connection be tween unit and electrode If this is faultless the electrode symbol illuminates green safety status Green Monopolar mode can be activated If the connection to the unit is interrupted or if the electrode contact tab is not fully inserted into the connection clamp the electrode symbol illuminates red safety sta tus Red Monopolar mode cannot be activated If you activate the device despite the warning an audible warning signal is emitted If a single surface electrode is con nected the contact between the electrode and the patient s skin is not monitored You will not receive a warning if the electrode becomes detached from the skin and there is a danger of burns 2 Safety Features 80104 521 06 2009 Dual surface neutral electrode To optimally utilize the unit s monitoring functions ERBE recommends connecting connected Neutral electrode a dual surface electrode and in particular the ERBE NESSY Omega electrode Dual surface or Neutral elec Apart from many oth
18. Monitoring System Reduce the effect or power setting 55 166 5 e Working with the Electrosurgical Unit a Tutorial Changes to the Basic program which have not been saved will be lost Save changed Basic program as 56 166 anew program Exceeding the electric current limit can indicate intense heating of the neutral elec trodes Check the neutral electrodes for heating and reduce the effect and or power setting if necessary Saving the amended Basic program under a new name In the preceding stages of the tutorial you made changes to the settings of the Basic program The settings will be lost if they are not saved You cannot overwrite the Basic program with your settings The Basic program cannot be changed but you can store the changed settings of the Basic program as a new program The settings for all receptacles will then be stored as a complete setting in the memory Adapta tion of the Basic program and its storage under a new name is a simple and fast method for creating a program Save as b Password Fig 5 24 Press the Enter button You will then move to the window Save as Optionally you can enter a password for the new program The program can then only be overwritten or deleted after entering the password Please do not forget your password because without it you cannot access the program either 1 Press the Selection button next to the menu item Password This takes you to the window Pass
19. Overwrite the program 3b ReMode with the new footswitch allocation 4 witch to program 3a ReMode Call up the monopolar receptacle with the Focus button If you now switch between the program 3a ReMode and 3b ReMode the display and the receptacle strip look as follows 61 166 5 e Working with the Electrosurgical Unit a Tutorial 62 166 3a ReMode BIPOLAR Guide gt oo Monopolar 4 receptacle x Mode gt AUTO CUT lt Effect E5 a gt o 100 lt Fig 5 36 3b ReMode p Bus Bipolar lt Lis receptacle Mode gt BIPOLAR CUT lt Effect i gt 4 j lt MONOPOLAR mi gt t pU 60 60 Fig 5 37 In the program 3a ReMode you will see the settings of the monopolar receptacle of this program The footswitch CUT and COAG is allocated to the monopolar re ceptacle If you switch to the program 3b ReMode you will see the settings of the bipolar re ceptacle The footswitch CUT and COAG is allocated to the bipolar receptacle By switching between the programs you have changed the allocation of the foot switch to the receptacles In the program 3b ReMode you can activate the modes of the bipolar receptacle with the footswitch Calling up Setup In Setup you can for example adjust the unit to the light conditions in the room Call up the window Guide Call up the menu item Additional Functions Call up the menu item Setup Use a selection button to select a S
20. a 50 e ffect1 0 0 100 200 Power HF max W Fig 7 13 SOFT COAG 250 e ffect8 200 Effect7 ffect6 150 ffect5 sz 5 Effect4 i08 Effect3 e Effect2 Si ffect1 a Pmax 100W 0 10 100 1000 10000 Resistance Ohm Fig 7 14 80104 521 06 2009 7 Monopolar Standard Modes 80104 521 06 2009 SOFT COAG 250 200 em ffect8 e tfoct7 e ffecto 150 gt e ffecto E Effect4 2 100 Effect3 e feci 50 I ffect1 0 0 50 100 150 200 250 Power W Fig 7 15 SWIFT COAG umm fi Properties Fast effective coagulation which is very suitable for dissection with high hemostasis due to its limited tissue cutting property Difference compared with SWIFT Optimised preparation characteristics due to changed ratio of crest factor to RF peak COAG voltage Applications Coagulation and dissection Suitable electrodes Ball electrodes for coagulation only knife or spatula electrodes for dissection and coagulation Technical data HF voltage waveform pulse modulated sinusoidal alternat ing voltage Rated frequency 350 KHz at Ry 500 ohms 10 Crest factor 3 5 at Ry 500 ohms Rated load resistor 500 ohms Max HF peak voltage 1550 Vp Number of effects 8 Constancy of effects automatic control of HF peak voltage HF power limitation 5 watts to 200 watts in 1 watt steps Max power output at rated load resis 200 watts 20 tor
21. and acoustic signal and automatically switches off the HF generator However the HF generator can be switched back on at any time resulting in renewed monitoring of the ON time This prevents major damage being caused by the accidental activa tion of an HF generator for indefinitely long periods 29 166 2 Safety Features Custom adaptation of maximum 30 166 ON time In view of the risk of thermal tissue damage due to the accidental switch on a HF generator which has been switched on accidentally should be switched off again au tomatically as far as possible immediately As the unit cannot automatically distin guish between the intentional and accidental switch on of a HF generator the auto matic switch off of a HF generator should not take place too quickly as this would hinder the operating surgeon with cutting or coagulation Setting of the ON time can only be carried out by a technician in the service programs The user was not informed of a change in maximum ON time Risk of accidental tissue damage to the patient All users must be informed of any change in maximum ON time at an early stage That is before the user works with the modified maximum ON time for the first time The temperature at the return electrode site increases during long and continuous activations therefore ensure that the cool ing phases between activations are sufficient Protection from operating errors To prevent operat
22. as the one specified on the unit s rating plate may be used When a fuse has been changed the function of the unit must be verified If the unit does not function properly or if there are any concerns please contact ERBE 80104 521 06 2009 1 Safety Instructions 80104 521 06 2009 Connection of unit equipment cart and power supply during cleaning and disinfection Risk of electric shock to the medical personnel Switch off the device Unplug the power cord of the device equipment cart Fire explosion In electrosurgery electric sparks and arcs occur at the instrument Flammable gases vapors and liquids can be set alight or caused to explode A DANGER Flammable anesthetics Risk of explosion to the patient and medical personnel Risk of damage to property Do not use flammable anesthetics when an operation is being performed on the head or thorax If use is unavoidable you must extract the anesthetics before performing electrosurgery Flammable gas mixture in TUR Transurethral Resection and TCR Transcervical Endometrial Resection Hydrogen and oxygen can ascend into the roof of the bladder the upper part of the prostate and the upper part of the uterus If you resect into this gas mixture it could combust Risk of combustion to the patient Allow the gas mixture to escape through the resectoscope sheath Do not resect into the gas mixture 4 DANGER Flammable endo
23. coagulation intensities than in other COAG modes If you want to use the potentially high coagulation intensities of SOFT COAG to the full select a low effect level and carry out coagulation for a longer period If you are only able to carry out coagulation for a short time select a high effect level You will then still achieve a high coagulation intensity in comparison with other COAG modes but do not use the potential coagulation intensity of SOFT COAG to the full In almost all operations that call for safe intense coagulation or in which adhe sion of the electrode would have a negative effect on the coagulation process Electrodes with a large contact surface e g ball electrodes for intense coagulation HF voltage waveform Rated frequency Crest factor Rated load resistor Max HF peak voltage Number of effects Constancy of effects unmodulated sinusoidal alternating voltage 350 KHz at Ry 500 ohms 10 1 4 at R 500 ohms 50 ohms 190 Vp 8 automatic control of HF peak voltage 79 1166 7 Monopolar Standard Modes 80 166 HF power limitation Max power output at rated load resis 200 watts 20 5 watts to 200 watts in 1 watt steps tor Diagrams SOFT COAG R 50 Ohm 250 e ffect8 _ 200 ffect7 m E ffect 8 150 ffect5 bs Effect4 T 100 Effect3 Effect o
24. cutting procedures forced coagulation and spray coagulation the unavoid able electric arcs between an active electrode and the tissue have the effect that a portion of the high frequency alternating current is rec tified Spasms or muscle contractions can occur Risk of injury to the patient s Set effect as low as possible relative to the required surgical ef fect 21 166 1 Safety Instructions 22 1166 Use of non approved internal cables by Technical Service This can result in the increased emission of electromagnetic waves or reduce the immunity of the device The unit may fail or not perform properly Technical Service may only use the internal cables that are list ed in the service manual for the device Stacked devices If you stack the device next to other equipment or with other equip ment the devices can affect each other The unit may fail or not perform properly The device may only be stacked next to or with VIO series units fitis necessary to operate the device near other equipment or stacked together with other equipment check whether the de vices are affecting each other Are the devices behaving unusu ally Do errors occur Damage to the unit and accessories Alcohol based spray disinfectant for fast disinfection With membrane keyboards and paint surfaces there is the risk of cracks Propanol and ethanol will erode surfaces Do not use these substances Alternate use
25. esie RR kalka Beli a MEN End 114 APC receptacle only available with the APC module 117 APC receptacle er t eee ue mi tdt 117 APC Standard Modes Only Available with an APC Denys 119 FORCED APC nine sn Ret e sil e E e d ie ee hilali 119 PRECISE APC ss mal eon e epe er EP 121 PULSED APC e RA 122 Argon assisteedAUTOCUTMode 124 Argon assisted HIGH CUT Mode nennen 126 Argon assisted DRY CUT Mode eene 128 Argon assisted DRY CUT Mode 130 Argon assisted SWIFT COAG Mode eene 132 Argon assisted SWIFT COAG Mode esee 134 Argon assisted FORCED COAG Mode eene 136 Argon assisted SOFT COAG Mode eee 138 APC Optional Modes Only Available with an APC Module 141 Argon assisted TWIN COAG Mode eene rennen 141 Installation cm 145 Ambient conditions eerie iaia he e d e i nail 145 Electrical installatlOn ect tet eee te e eR ette 146 Install electrosurgical unit on overhead support eee 148 Installing the unit on an ERBE equipment cart seen 149 Cleaning and Disinfection eee 151 Wipe disinfection dne gemere tret te e peo ere ees 151 Instructions for cleaning and disinfection se
26. flow through the two surfaces of the neutral elec trode If the currents differ slightly from each other a green indicator window ap pears on the display Monopolar mode can still be activated but you should correct the position of the neutral electrode as soon as possible If the currents differ too greatly from each other the dual surface electrode symbol on the VIO illuminates red Monopolar mode cannot be activated If you attempt ac tivation an audible warning signal is emitted A red warning message appears on the display When applying the neutral electrode ensure that the line of symmetry points toward the operating field NESSY Dual surface gt lt gt lt gt lt gt lt Fig 5 22 If you press the Focus button on the neutral electrode socket you change to the NESSY window You will see a traffic light symbol 1 According to the contact resistance between skin and electrode this symbol shows the following e Safety status Green The unit can be activated without any danger for the patient e Safety status Red You cannot activate the unit The middle indicator 2 shows the contact resistance as a numerical value Neutral electrode Dual surface setup The diagram on the right 3 shows the con tact resistance as a bar The upper and lower limits of the Green safety status are in dicated by a red line at the top and bottom The lower limit is 20 ohms The upper limit is 120 ohms Neutral elec
27. for damage every time before using them e g footswitch cords of instruments and the return electrode equipment cart You must not use damaged equipment or damaged accessories Replace defective accessories If the equipment or equipment cart is damaged please contact our customer service For your safety and that of the patient Never attempt to perform repairs or make modifications yourself Any modification will invalidate liability on the part of ERBE Elektromedizin GmbH HF leakage current flows through metal parts The patient must not have contact with electrically conductive ob jects That includes metal parts of the operating table for example HF current can be discharged through points of contact accidental ly HF leakage current Risk of burns to the patient Position the patient on dry antistatic drapes Ifthe drapes can become wet during the operation due to sweat blood irrigation liquid urine etc lay a waterproof sheet over the drapes HF leakage current flows through monitoring electrodes HF current can be discharged through points of contact between the skin and monitoring electrodes accidentally HF leakage current Risk of burns to the patient Position monitoring electrodes as far away as possible from the surgical field area where electrosurgical instruments are used Do not use needle electrodes for monitoring during electrosur gery Where possible use mo
28. for the HF output param eters This system monitors any divergence between the actual value and the set point of the HF output parameters selected and emits warning signals or switches off the HF generator if the divergence is so great that the required quality of the re spective effect CUT or COAG is no longer guaranteed For the operating surgeon the display of any equipment output error allows him to immediately see in the event of divergence or absence of the required effect wheth er this defect has been caused by the unit With the unit any divergence of the HF output parameters from the HF output parameters actually selected can only be caused by loads with an excessively low resistance e g too large coagulation elec trodes short circuit between active electrode and return electrode or by a defect in the unit Automatic monitoring of the ON time With proper use a high frequency generator is only briefly activated to carry out a cut or coagulation using a fingerswitch pedal or AUTO START This generally only takes a few seconds A defect in the unit in the accessories or in usage may cause the high frequency generator to be switched on unintentionally To prevent major damage being caused by accidental activation of a high frequency generator the unit is equipped with a monitor which automatically monitors the ON time of the high frequency generator When a predetermined maximum ON time is exceeded the monitor emits a visual
29. instrument This is not pos sible if the tips are touching each other This is not possible if there is tissue contact NESSY contact Please check contact between skin and neutral electrode patient plate Recalibrating glass keyboard Do not touch The AUTO START function is only permissible up to a max power output of 50 W Safety check due Deadline for next safety check has been reached Inform Technical Service Please assign activation type Newly connected instrument not assigned to either footswitch or AUTO START Neonatal NE Monitoring System Reduce the effect or power setting Fault with instrument detection Do not use instrument have it checked 155 166 16 Status Messages Error Messages 156 166 80104 521 06 2009 80104 521 06 2009 17 General Technical Data CHAPTER 17 General Technical Data Power connection Rated supply voltage 100 V 120 V 10 220 V 240 V 10 Rated supply frequency 50 60 Hz Line current 8A 4A Power input in standby mode 40 watts Power input with max HF output 500 watts 920 VA Terminal for grounding potential egualization yes Power fuses T8A T4A Operating mode Intermittent operation ON time 25 e g activated for 10 sec deactivated for 30 sec Dimensions and weight Width x height x depth 410 x 165 x 380mm Weight 9 5 kg Ambient conditions for transport and storage of unit Temperature 40 C to 70 C Relati
30. of disinfectant solutions based on different active ingredients A color reaction may occur with plastics Do not use these substances alternately Mix up of receptacles on monopolar receptacle modules 20140 622 20140 623 If the receptacles are mixed up the unit will be damaged If you use a connecting cord with a monopolar 4 mm dia con nector you may only plug the connector into the receptacle with the blue ring The correct receptacle is marked with an arrow on the illustration 80104 521 06 2009 1 Safety Instructions 80104 521 06 2009 Fig 1 2 Electric load on instrument too high The instrument can be damaged If the damaged area comes into contact with tissue it can lead to un intentional coagulation Determine the electrical capacity of the instrument It is either printed on the instrument or can be found in the user manual Compare the electrical capacity of the instrument with the max imum HF peak voltage of the required mode Instructions are available in the Accessories chapter Very long activation cycles without cooling phases The electrosurgical unit is designed and tested for a relative ON time of 25 conforming to TEC 60601 2 2 If you perform very long activation cycles without appropriate cooling phases the unit can be damaged Keep to the 25 relative ON time see also Technical Data Op erating Mode if you operate the unit for a lengthy peri
31. output Adjustment of the intensity of the thermal effect with the power When the effect level is changed the pulse frequency also changes Rigid APC applicators flexible APC probes HF voltage waveform pulse modulated sinusoidal alternat ing voltage Rated frequency 350 kHz at R 500 ohms Crest factor 7 4 at R 500 ohms Rated load resistor 500 ohms Max HF peak voltage 4 300 Vp Number of effects 2 80104 521 06 2009 12 APC Standard Modes Only Available with an APC Module 80104 521 06 2009 Constancy of effects Restriction of HF peak voltage HF power limitation 1 W to 120 W in 1 W steps Max power output at rated load resis 120 watts 20 tor Diagrams PULSED APC R 500 Ohm 140 N o ffect 1 2 o o o o o A O Power HF output W N o o o 20 40 60 80 100 120 140 Power HF max W Fig 12 5 PULSED APC 140 120 100 80 m feci 1 2 Eff 1 2 Pmax 60W 60 m 20W Power W 40 20 100 1000 10000 Resistance Ohm Fig 12 6 123 166 12 APC Standard Modes Only Available with an APC Module 124 166 Properties Areas of use Suitable electrodes Technical data PULSED APC 5000 4500 4000 3500 3000 2500 2000 1500 1000 500 feci 1 2 U HF Vp 0 20 40 60
32. pin spacing 28 5 mm 67 166 6 Description of receptacle hardware Instrument detection with multi functional receptacle Cutting and coagulation modes 68 166 Receptacle module BI 2 pin 22 28 8 4 69 Fig 6 8 ERBE No 20140 613 You can connect ONE of the following connectors as required international bipo lar connector with 2 pins pin spacing 22 mm international bipolar connector with 2 pins pin spacing 28 5 mm ERBE standard bipolar connector Multifunctional receptacle Instruments with instrument detection are identified only at multifunctional recep tacles Standard Monopolar AUTO CUT HIGH CUT DRYCUT DRYCUT e SOFT COAG SWIFT COAG SWIFT COAG FORCED COAG SPRAY COAG 80104 521 06 2009 Optional Monopolar PRECISE CUT ENDOCUTQ ENDOCUTI PRECISE COAG TWIN COAG Standard Bipolar BIPOLAR CUT e BIPOLAR CUT e BIPOLAR SOFT COAG BIPOLAR SOFT COAG BIPOLAR FORCED COAG Optional Bipolar BiClamp BIPOLAR PRECISE CUT BIPOLAR PRECISE COAG 6 Description of receptacle hardware 80104 521 06 2009 Instrument compatibility Socket module MF 0 Fig 6 9 ERBE No 20140 630 The receptacle module is suitable for the following connectors 5 pole ERBE mul tifunctional connector Receptacle for return electrode Function The receptacle is used to connect a return electrode with monopolar modes Connec
33. the patient s skin or the application direction of the contact surface You will not receive a warning if the electrode becomes detached from the skin You will not receive a warning if the application direction of the re turn electrode is incorrect Risk of burns to the patient To rule out the possibility of a short circuit in the connecting cord and the clip before use see Chapter 2 of this Manual Safe ty Features for NESSY Note ERBE recommends the use of split return electrodes in combination with the NESSY setting set to NE dynamic or NE dual surface With this combination the optimal use of the safety monitoring functions are given see chapter 2 NESSY Safety Features If the unit is activated in a monopolar mode using a cable with a short the unit will give an audible warning signal and will display a B B error message on the screen Defective unit Undesirable rise in output level due to failure of electrosurgi cal unit Risk of accidental tissue damage to the patient The device shuts off independently To guard against a possible failure of the electrosurgical unit have the device checked for safety at least once a year Routine safety testing not being done Risk of injury or death for patients and medical staff Risk of dam age to property Have the device checked for safety at least once a year You must not use a device that is not safe 80104 521 06 2009 1 Safety In
34. the yellow pedal of the dual pedal footswitch 2 gt Guide MONOPOLAR progs Mode es Mode gt HIGH CUT FORCED COAG Fig 5 18 In the window Cut Coag Settings you will see the monopolar receptacle displayed The yellow pedal allocated is highlighted yellow in the display The yellow pedal of the dual pedal footswitch 1 lights up at the monopolar receptacle You can thus activate the CUT function of the monopolar receptacle with the yellow pedal of the dual pedal footswitch No footswitch is allocated to the COAG function of the monopolar receptacle It is possible to switch on the unit select a program and only then connect a foot switch The unit will detect the footswitch The footswitch symbols at the recepta cles light up according to the footswitch assignment of the program Activation of CUT and COAG modes with fingerswitch Auto Start If an instrument has a fingerswitch you can also activate any receptacle with the fin gerswitch The option of fingerswitch activation is not shown in the window Cut Coag Settings If the bipolar receptacle has been selected you can select AUTO START 1 or AUTO START 2 in the window receptacle Selected When the instrument touches tissue coagulation starts automatically after a specified period of time You can ad just this time period in Setup See p 64 Selection of the Auto Start function is shown in the window Cut Coag Settings of the bipolar receptacle The symbol for A
35. up the monopolar receptacle 2 Change the setting according to the following specifications AUTO CUT Effect 5 100 W SPRAY COAG Effect 2 110 W Allocate the footswitch CUT and COAG to the monopolar receptacle 3 Press the Enter button as D gt BEG abc123 Return gt Password No Fig 5 30 4 You will then move to the window Save as Press the selection button next to the menu item Number The field Number is marked gray with a cursor Select a Number with the Up Down buttons The tutorial uses number 3 The number refers to the free memory locations of the unit 59 166 5 e Working with the Electrosurgical Unit a Tutorial 5 Press the selection button next to the menu item Name Enter ReMode Depress the Enter button for 3 sec to save the program 3 ReMode b B Monopolar E 4 Med receptacle e Mode x Mode gt AUTO CUT SPRAY COAG E Effect gt 5 J lt EPM i E y e gt 100 Uu lt Fig 5 31 3 ReMode Guide B Monopolar 4 shee receptacle es B Mode Mode gt DRYCUT elko e 4 Effect gt lt max watts max watts gt 80 90 lt Fig 5 32 6 You will then move to the window Cut Coag Settings There you will see the name of the program 3 ReMode at the top of the window Change the settings of the program 3 ReMode according to the following specifications DRY CUT Effect 3 80 W FORCED COAG 1 90 W 7 Press the Enter button Save Prog no 3
36. x1 kV differential mode 2 kV common mode lt 5 U 4 59596 dip in U r for 0 5 cycle 40 U 4 6096 dip in Uy for 5 cycles 70 U 4 3096 dip in U 7 for 25 cycles lt 5 U 4 59596 dip in U 7 for5s Electromagnetic environ ment guidance Floors should be wood con crete or ceramic tile If floors are covered with non conduc tive synthetic material the rel ative humidity should be at least 3096 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the equipment requires continued operation during power mains interrup tions it is recommended that the equipment be powered from an uninterruptible power supply or a battery 80104 521 06 2009 80104 521 06 2009 18 Information on electromagnetic compatibility EMC Guidance and manufacturer s declaration electromagnetic immunity Power frequency 50 3 Alm 3 Alm Power frequency magnetic 60 Hz magnetic field fields should be at levels char IEC 61000 4 8 acteristic of a typical location in a typical commercial or hos pital environment Note Uy is the a c mains voltage prior to application of the test level Guidance and manufacturer s declaration electromagnetic immunity The equipment is intended for use in th
37. 04 521 06 2009 Operating errors by persons without training Risks due to the environment Electric shock Fire explosion Burns Risks due to incorrect use of the return electrode Defective unit Interference caused by the unit Damage to the unit and accessories Notes Operating errors by persons without training Operating errors by persons without training Persons without training can operate the unit incorrectly Risk of injury or death for patients and medical staff Risk of dam age to property The equipment may only be used by persons who have been trained on how to use it properly according to this User Manual 1 Safety Instructions 80104 521 06 2009 Training may only be carried out by persons who are suitable on the basis of their knowledge and practical experience Inthe event of uncertainties or if you have any questions please contact ERBE Elektromedizin You will find the addresses in the address list at the end of this User Manual Risks due to the environment Interference with the unit by portable and mobile HF communi cation devices e g mobile phones WLAN equipment Electromagnetic waves emitted by portable and mobile HF commu nication devices can effect the unit The unit may fail or not perform properly Please see the table Recommended separation distances be tween portable and mobile HF communications equipment and the equipment at the end of this User Manual
38. 09 PRECISE CUT 450 400 350 Effect8 ffect7 _ 300 Effect6 250 Effect5 E 200 Effect4 2 Effect3 150 c feci 100 Effect 50 0 0 10 20 30 40 50 60 Power W Fig 9 3 ENDO CUT Q Properties The cut consists of alternating cutting and coagulating phases The cut is easy to control and is characterized by a reproducible preselectable coagulation property while cutting Areas of use Endoscopic interventions in which alternating cutting and coagulation with activa tion is called for Suitable electrodes Monofilament and polyfilament snare electrodes Expert mode Fora customized setting you can have Expert mode activated by a service techni cian The Cut Coag Settings window will then also show the parameters Cutting duration and Cutting interval Cutting duration Depending on the size type and location of lesions it may be advantageous to vary cutting duration You can set cutting duration to one of 4 levels Cutting duration has a major influ ence on cutting width Cutting interval The cutting interval is the amount of time between the start of a cutting cycle and the start of the next cutting cycle The cutting interval is thus comprised of one cut ting cycle and one coagulation cycle You can set the cutting interval to one of 10 levels The higher the level the longer the cutting interval and coagulation cycle A short cutting i
39. 09 5 e Working with the Electrosurgical Unit a Tutorial 80104 521 06 2009 1 Call up window Select activa tion type 2 Select footswitch MR 0 Basic prog Guide eme Monopolar receptacle Mode x HIGH CUT FORCED COAG Effect max watts max watts 140 80 First use a Focus button 1 to select a receptacle to which you want to allocate a footswitch You will see the functions of the receptacle in the window Cut Coag Settings In our example it is the monopolar receptacle Press the selection button next to the menu item Footswitch Select activation type No ER gt len lt e EB B a gt O B More Fig 5 16 Select activation type lt 4 Fig 5 17 In the window Fig 5 17 you will see a list of the possible footswitch allocations Scroll with the Down button 1 to the next window Fig 5 16 You can also use the Select button next to the Other modes menu item e Dual pedal footswitch yellow and blue pedal e Dual pedal footswitch blue pedal e Dual pedal footswitch yellow pedal Blue single pedal footswitch lt gt O m No lt 5 e Working with the Electrosurgical Unit a Tutorial Orientation Footswitch display in the window Cut Coag Set tings and on the receptacle 50 166 Plug and Play Fingerswitch activation Auto Start Auto Stop The active footswitch is marked in green Use the selection button to select a foot switch e g
40. 100 1000 10000 Resistance Ohm Fig 12 9 125 166 12 APC Standard Modes Only Available with an APC Module 126 166 Properties Areas of use Suitable electrodes Technical data AUTO CUT 800 700 e ffect8 600 Effeci7 500 e ffecto Effect5 E 400 n Effect4 2 300 Effect3 e Effect2 200 een ffect1 100 0 0 50 100 150 200 250 300 350 Power HF max W Fig 12 10 Argon assisted HIGH CUT Mode o o e n 2 e e o 5 amm pl Reproducible tissue sparing cuts in particular in poorly conductive and varying tis sue The argon gas reduces the formation of gas and carbonization Several including cutting fat containing structures APC applicators with adjustable electrodes as well as the laparoscopic hook elec trode HF voltage waveform Rated frequency Crest factor Rated load resistor Max HF peak voltage Number of effects Constancy of effects HF power limitation Max power output at rated load resis tor unmodulated sinusoidal alternating voltage 350 kHz at R 500 ohms 10 1 4 at Rj 500 ohms 500 ohms 950 Vp with an arc 8 automatic control of arc intensity 10 watts to 300 watts in 1 watt steps 300 watts 20 80104 521 06 2009 12 APC Standard Modes Only Available with an APC Module 80104 521 06 2009 Diagrams HIGH CUT
41. 14 You will then move to the window Cut power limitation Selection of a power lim itation level is for the safety of the patient and protects the instrument from damage You will see a numerical display for the power limitation 1 and a display in the form of a bar diagram 2 1 Select a power limitation level with the Up Down buttons 3 example 140 watts 2 Confirm your selection by pressing the Enter button 4 or by pressing the selection button next to the menu item Return You will then move back to the window Cut Coag Settings Select COAG mode COAG effect and COAG power limitation Selection of the COAG window is made in the same way as for selection of the CUT window Please try it out Activation of CUT and COAG modes with footswitch At the back of the electrosurgical unit you can connect a dual pedal footswitch and a single pedal footswitch See the chapter Installation The dual pedal footswitch has a yellow pedal for the activation of CUT and a blue pedal for the activation of COAG The pedal of the single pedal footswitch is blue It is also used to activate COAG The pedals of the dual pedal footswitch CUT yellow COAG blue and the pedal of the single pedal footswitch COAG blue can be freely allocated to the recepta cles of the electrosurgical unit If you have connected an APC 2 to the electrosurgi cal unit you can also allocate the pedals to the receptacles of the APC 2 80104 521 06 20
42. 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed HF transmitters an electromagnetic site survey should be consid ered If the measured field strength in the location in which the equipment is used exceeds the applicable compliance level above the equipment should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the equipment 80104 521 06 2009 b Over the frequency range 150 kHz to 80 MEZ field strengths should be less than 3 V m Recommended separation distances between portable and mobile HF communications equipment and the equipment The equipment is intended for use in an electromagnetic environment in which radiated HF disturbances are controlled The customer or the user of the equipment can help prevent electromagnetic interference This can be achieved by main taining the minimum distance recommended below between the communications equipment transmitters and the equip ment The minimum distance depends on the maximum output power and t
43. 2009 4 Description of the Controls 5 Select CUT power limitation Calls up the window for selection of a CUT power limitation level 6 Socket Selected Calls up the window for selection of the footswitches and Auto Start modes 7 Select COAG mode Calls up the window for selection of a COAG mode 8 Select COAG effect Calls up the window for selection of a COAG effect 9 Select COAG power limitation Calls up the window for selection of a COAG power limitation level 19 Signal for smoke evacuator If this signal is green in the control field Cutting or Coagulate the smoke evacuator will automatically start on activation of the respective mode Controls on the back 90 su i e e a EB y i Fig 4 3 Please consult the chapter The controls described below are important for installation of the unit Installation Sockets 1 and 2 footswitch sockets You can connect a single pedal and a dual pedal footswitch to these receptacles The dual pedal footswitch can be connected to either receptacle 1 or receptacle 2 The same applies to the single pedal footswitch 3 ECB sockets ECB means ERBE Communication Bus You can connect other units to the electrosurgical unit e g an APC or a smoke evacuator The electrosurgical unit then functions as a control unit whose display shows the func
44. 5 E PH Effect4 2 Effect3 40 e Effect2 Ln 20 Effect1 0 0 10 20 30 40 50 60 Power W Fig 9 8 TWIN COAG m _ ma a Properties Fast effective coagulation which is highly suitable for preparation with high hemo stasis owing to its limited tissue cutting property Two monopolar instruments can be activated at the same time WARNING In the TWIN COAG mode the output power of any of the active elec trodes can change 107 166 9 Monopolar Optional Modes 108 166 Setting Activation Areas of use Suitable electrodes Technical data Diagrams When carrying out the first selection of TWIN COAG you are reguested to select a second additional monopolar receptacle on the VIO or APC 2 by pressing the re quired Focus button The TWIN COAG function can be called up on the two selected receptacles simul taneously If one of the two receptacles requires a CUT function they must be acti vated alternately Especially in disciplines where simultaneous coagulation and preparation is re quired e g in heart and breast surgery Ball electrodes for coagulation Knife or blade electrodes for preparation and coag ulation HF voltage waveform Rated frequency Crest factor Rated load resistor Max HF peak voltage Number of effects Constancy of effects HF power limitation pulse modulated sinusoidal alternat ing voltage 350 kHz at Ry 500 ohms 10 5 0 at Rj 500 ohms
45. 81 166 7 Monopolar Standard Modes 82 166 Diagrams SWIFT COAG R 500 Ohm 250 e Effect m ffect7 200 ec effect E ffect5 2 8 150 Effect4 e Effect3 T 100 e Effect2 Effect o o B0 0 0 100 200 Power HF max W Fig 7 16 SWIFT COAG 250 e Fffect8 200 effect em ffecto 150 fect5 5 Effect4 3 amm e 100 Effect3 c Effect2 2 ffect1 a Pmax 100W 0 10 100 1000 10000 Resistance Ohm Fig 7 17 80104 521 06 2009 7 Monopolar Standard Modes 80104 521 06 2009 SWIFT COAG 1800 1600 em ffect8 1400 m ffect7 e 0 eren 1000 Effects 2 Effect3 600 ffect2 400 E fect 200 0 0 50 100 150 200 250 Power W Fig 7 18 SWIFT COAG Properties Fast effective coagulation which is very suitable for dissection with high hemostasis due to its limited tissue cutting property Applications Coagulation and dissection Suitable electrodes Ball electrodes for coagulation only knife or spatula electrodes for dissection and coagulation Technical data HF voltage waveform pulse modulated sinusoidal alternat ing voltage Rated frequency 350 kHz at R 500 ohms 10 Crest factor 5 4 at Ry 500 ohms Rated load resistor 500 ohms Max HF peak voltage 2500 Vp Number of effects 8 Constancy of effects automatic co
46. COAG 2000 1800 1600 1400 1200 1000 800 600 400 200 Effect4 Effect3 c Fffect2 n Effect U HF Vp 0 20 40 60 80 100 120 140 Power W Fig 12 28 Argon assisted SOFT COAG Mode Carbonization of the tissue is prevented adhesion of the electrode to the tissue is greatly reduced Great coagulation depth in comparison to other COAG modes If you wish to fully utilize the potentially great coagulation depth of SOFT COAG select a low effect level and coagulate over a long period If you can only coagulate for a short time select a high effect level In comparison to other COAG modes you will attain an even greater coagulation depth but do not fully utilize the potential coagulation depth of SOFT COAG In almost all operations which require safe deep contact coagulation or in which an adhesion of the electrode would have a negative effect on the coagulation pro cess Clamp coagulation e g via insulated monopolar forceps Contact electrodes for this in particular electrodes with large contact surface e g ball electrodes for deep coagulation Note When using the ERBE VIO APC hand piece a conventional 4 mm electrode can be used instead of the argon applicator For this the flow setting must be set to 0 HF voltage waveform unmodulated sinusoidal alternating voltage Rated frequency 350 KHz at Ry 500 ohms 10 Crest factor 1 4 at R 500 ohms
47. FORC APC 4 4 120w MAE APC lt v vi gt Oth E Fig 5 2 1 o In the sample display the APC 2 has one receptacle 1 The box showing the second receptacle 2 is empty Although the functions of the APC 2 are set on the electrosurgical unit operation of the APC 2 is described in a separate user manual Please consult the chapter Work ing with the APC 2 in the user manual for the APC 2 5 Getting an overview assign The sample display shows the symbol of the Down button 3 Underneath you can ment of the active program for see IES An IES 2 is connected to the electrosurgical unit Press the Down button thelES2 onthe front panel of the electrosurgical unit and keep it pressed until you see the JES 2 settings for VIO 300 D window You can also scroll to the JES 2 settings for APC window Although the functions of the IES 2 are set on the electrosurgical unit operation of the IES 2 is described in a separate user manual Please consult the chapter Working with the IES 2 in the user manual for the IES 2 Press the Up button several times You will move to the first view of the window Guide 41 1166 5 e Working with the Electrosurgical Unit a Tutorial 42 1166 Adopt Program 1 Call up window Select Program Adopt Program Guide 1 program xy Adopt Bipolar receptacle 4 program Bi cur NER 4 cow ENT Select Monop receptacle program DRY FORCED 4 4 180W 2 80W O 300 D EN
48. G Extremely fine adjustment extremely fine precision power output in range from to 50 watts Coagulation processes where stress for tissue or patient must be minimized e g neurosurgery ENT dermatology In the lower output range the degree of coagulation can be set lower and more accu rately Microsurgical instruments electrodes for microsurgery HF voltage waveform Rated frequency Crest factor Rated load resistor Max HF peak voltage Number of effects Constancy of effects HF power limitation unmodulated sinusoidal alternating voltage 350 KHz at Ry 500 ohms 10 1 4 at Rg 500 ohms 50 ohms 110 Vp 8 automatic control of HF peak voltage 80104 521 06 2009 1 watt to 50 watts in 1 watt steps Max power output at rated load resis 50 watts 20 tor PRECISE COAG R 50 Ohm 60 50 e Effect 7 8 pa 40 e ffect6 a Effoct5 30 Effect4 Effect3 9 20 e Fffect2 d Effect 10 0 0 10 20 30 40 50 60 Power HF max W Fig 9 6 9 Monopolar Optional Modes 80104 521 06 2009 PRECISE COAG 60 50 em ffect8 Effect 40 fect6 z F fect5 5 30 Effect4 Effect 20 e Effect2 Effect 10 Pmax 25W 0 10 100 1000 10000 Resistance Ohm Fig 9 7 PRECISE COAG 120 100 F ffect8 ffect7 _ 80 Effect6 rfect
49. H CUT You will then move back to the window Cut Coag Settings If you want to deactivate the CUT mode for the receptacle select CUT off in the se lection list If you wish you can display information about the active CUT mode after selection of the CUT mode Press the selection button next to the menu item Mode again Press the selection button next to the menu item nfo 45 166 5 e Working with the Electrosurgical Unit a Tutorial 46 166 1 Call up CUT Effect VIO info Mode gt gt Please note gt E gt Return 4 Fig 5 10 HIGH CUT Mode lt Properties Reproducible tissue sparing cuts in particular in poorly conductive and varying tissue 4 Areas of use Several including cutting fat containing structures cutting under water e g with TUR P Suitable electrodes Knife spatula and loop electrodes Scroll with the Up Down buttons or use the Select button next to the Other modes menu item to display the description of the mode selected After you have read the text press the selection button next to the menu item Return You will then move back to the window Select cut mode There press the selection button next to the menu item Return You will then move back to the window Cut Coag Settings Useful information can be called up in many windows for the unit The method used to call up such information is always identical It is not explained again in the next stages of the tut
50. Hz at Ry 500 ohms Crest factor 7 0 at Ry 500 ohms Rated load resistor 500 ohms Max HF peak voltage 4300 Vp Constancy of effects Restriction of HF peak voltage HF power limitation 5 W to 120 W in 1 W steps Max power output at rated load resis 120 watts 20 tor 119 166 12 APC Standard Modes Only Available with an APC Module 120 166 Diagrams FORCED APC R 500 Ohm 140 120 100 80 60 40 Power HF output W 20 O 20 40 60 80 100 120 140 Power HF max W Fig 12 1 FORCED APC 140 120 100 80 e Pmax 120W Pmax 60W 60 120W Power W 40 20 10 100 1000 10000 Resistance Ohm Fig 12 2 80104 521 06 2009 12 APC Standard Modes Only Available with an APC Module 80104 521 06 2009 Properties Areas of use Setting Modulation Suitable instruments Technical data FORCED APC 5000 4500 4000 3500 3000 2500 2000 1500 1000 500 U HF Vp 0 20 40 60 80 100 120 140 Power W Fig 12 3 PRECISE APC s A APC with well controllable change of effect at the tissue surface largely indepen dent of the distance between applicator and tissue Hemostasis of diffuse areas of bleeding Devitalization and reduction of tissue with emphasis on reproducibly lo
51. Modes BIPOLAR CUT Properties Cutting current that only flows directly around the distal end of the applicator You can use the effect levels to set the degree of haemostasis at the cut edge PPS Power Peak System The BIPOLAR CUT mode is equipped with PPS A special problem during incision may be posed by the initial incision phase in particular when the cutting electrode is pressed firmly against the tissue to be cut before activation of the HF generator so that the cutting electrode has a relatively extensive and thus low resistance contact with the tissue This is generally the case for example with TUR and endoscopic polypectomy In such cases the HF generator must offer an above average output so that the initial incision is not delayed as otherwise an excessive coagulation necro sis may be produced at the point of initial incision The VIO is equipped with auto matic power control which detects low resistance loads and controls the HF gener ator so that it briefly provides sufficient output to ensure the HF voltage necessary for the cutting quality selected or the intensity of the electric arcs even with low re sistance loads Thanks to this feature the average output can be limited to relatively low levels something which represents improved protection from unintentional thermal tissue damage Suitable electrodes Special applicators bipolar electrodes with a rigid or retractable cutting needle in laparoscopy neurosurgery and ENT
52. NESSY compares the currents that flow through the two surfaces of the neutral elec trode If the currents differ slightly from each other a green indicator window ap pears on the display Monopolar mode can still be activated but you should correct the position of the neutral electrode as soon as possible If the currents differ too greatly from each other the dual surface electrode symbol on the VIO illuminates red Monopolar mode cannot be activated If you attempt ac tivation an audible warning signal is emitted A red warning message appears on the display When applying the neutral electrode ensure that the line of symmetry points toward the operating field 27 1166 2 Safety Features Checking function of the NESSY window when a dual surface electrode is connected with Neutral electrode Dual sur face or Neutral electrode Either way setup Dual surface neutral elecirode connected Neutral electrode Dynamic setup Checking function of the NESSY window when a dual surface electrode is connected with Neutral electrode Dynamic setup 28 166 NESSY Dual surface gt lt gt lt gt lt gt Return 4 Fig 2 4 If you press the Focus button on the neutral electrode socket you change to the NESSY window You will see a traffic light symbol 1 According to the contact resistance between skin and electrode this symbol shows the following e Safety status Green The unit can be activate
53. R 500 Ohm 350 300 p e Effect 1 8 250 5 amp 200 2 o 150 2 o 100 a 50 0 0 100 200 300 400 Power HF max W Fig 12 11 HIGH CUT 350 e Effect ffect7 e ffect6 Effect5 5 Effect4 Effect3 e Effect2 ffect1 a P max 150W 100 1000 10000 Resistance Ohm Fig 12 12 127 166 12 APC Standard Modes Only Available with an APC Module HIGH CUT e Effecta ffect7 e ffect6 fect5 Effect4 Effect3 e Effect2 fect1 U HF Vp 0 50 100 150 200 250 300 350 Power W Fig 12 13 Argon assisted DRY CUT Mode gt a o 2 a o o a a E Properties Intense hemostasis with somewhat slower cutting speed The argon gas reduces the formation of smoke and the carbonization Areas of use E g cuts in open surgery and cuts in endoscopic operations that require very good primary hemostasis during the cut and tolerate a somewhat slower cutting speed Differences from AUTO CUT and Medium to intense hemostasis HIGH CUT Suitable electrodes APC applicators with adjustable electrodes as well as the laparoscopic hook elec trode Technical data i i HF voltage waveform pulse modulated sinusoidal alternat ing voltage Rated frequency 350 kHz at Rj 500 ohms 10 Crest factor effect 1 4 3 0 effect 5 6 3 2 effect 7 8 3 8 at Rx 500 ohms Rated load resistor 500 ohms Ma
54. Rj 500 ohms 10 Crest factor 6 0 at Ry 500 ohms Rated load resistor 500 ohms Max HF peak voltage 1800 Vp Number of effects 4 Constancy of effects automatic control of HF peak voltage HF power limitation 5 watts to 120 watts in 1 watt steps Max power output at rated load resis 120 watts 20 tor 85 166 7 Monopolar Standard Modes 86 166 Diagrams FORCED COAG R 500 Ohm 140 120 me Effect 3 4 Effect2 2 amp 80 F ffect1 3 E 60 3 o 40 a 20 0 0 50 100 150 Power HF max W Fig 7 22 FORCED COAG 140 120 199 Efeci4 S 80 Effect3 o e Effect2 60 F ffect1 oP max 60W 40 20 0 10 100 1000 10000 Resistance Ohm Fig 7 23 80104 521 06 2009 7 Monopolar Standard Modes FORCED COAG 2000 1800 1600 1400 1200 Effect4 1000 Effect3 c Effect2 U HF Vp 800 600 ffect1 400 200 0 20 40 60 80 100 120 140 Power W Fig 7 24 SPRAY COAG EE INC 80104 521 06 2009 Properties Contact free efficient surface coagulation low penetration depths Automatic dos ing of power within the pre selected limits Areas of use Coagulation of diffuse hemorrhage WARNING Only use insulated monopolar metal forceps for clamp coagulation Suitable e
55. T mw io lt gt Return gt Monop receptacle AP v Upmax 740Vp 1 1 gt lt Fig 3 2 FORCED CO w A 80104 521 06 2009 The AUTO CUT mode with Effect 8 would load the instrument with peak voltage of 740 Vp 1 Do not operate the instrument with Effect 8 of the AUTO CUT mode The electrical capacity of the instrument 500 Vp is less than the HF peak voltage 740 Vp of the AUTO CUT mode with Effect 8 gt Reduce the effect Press the down button until the HF peak voltage 1 is the same or less than 500 Vp Select Cut Effect Monop receptacle AUTO CUT i lt a gt 4 _ a 3 Return 4 v Upmax 490Vp 1 Fig 3 3 32 1166 3 Accessories 80104 521 06 2009 gt The HF peak voltage 490 Vp of the AUTO CUT mode with Effect 5 is less than the electrical capacity of the instrument 500 Vp You may operate the instru ment with these settings Confirm the settings Press Enter You can also check the compatibility of instruments and COAG mode in the same way Call up the Select Coag Effect window Check compatibility of the return electrode Non compatible or single surface return electrode When applying a non compatible return electrode it should be ex pected that monitoring the contact between return electrode and skin is faulty When applying a single surface return electrode the contact be tween return electrode and skin is not monitored If c
56. Technical data HF voltage waveform Rated frequency Crest factor Rated load resistor Max HF peak voltage Number of effects Constancy of effects HF power limitation Max power output at rated load resis tor unmodulated sinusoidal alternating voltage 350 kHz at R 500 ohms 10 1 4 at Ry 500 ohms 500 ohms 740 Vp 8 automatic control of HF peak voltage 1 watts to 100 watts in 1 watt steps 100 watts 20 91 166 8 Bipolar Standard Modes 92 166 Diagrams BIPOLAR CUT R 500 Ohm 120 100 F ffect 1 8 80 2 2 o 60 u r 40 o a 20 0 0 20 40 60 80 100 120 Power HF max W Fig 8 1 BIPOLAR CUT 120 100 1 emu ffect 7 8 VA ffect6 _ 80 e Effect5 NN Effect4 S 60 Effect3 NS a e Fffect2 40 Effect e P max 50W 20 0 100 1000 10000 Resistance Ohm Fig 8 2 80104 521 06 2009 8 Bipolar Standard Modes 80104 521 06 2009 BIPOLAR CUT 800 700 effect 8 600 F fect 7 500 F ffect6 gt e ffect5 we 900 Effect4 2 300 Effect3 e Effect2 200 ffect1 100 0 0 20 40 60 80 100 120 Power W Fig 8 3 BIPOLAR CUT Properties Reproducible tissue sparing cuts You can use the effect levels to set the degree of hemostasis at the cut edge Areas of use Cutting procedures in Bipolar Resect
57. VIO 300 D User Manual 06 09 V 1 7 x VIO 300 D User Manual Peter Mock Technical Editor Tel 49 70 71 75 52 37 E mail pmock erbe med de I shall be very pleased if this User Manual can make your work easier and help you to use all the functions of your unit safely It has been produced with great care by me in collaboration with development engineers and quality personnel The use of publishing software and digital photography provided the documentation team with layout flexibility Our object was to achieve a clear combination of text and photographs The translation of the text into your language is subjected to a strict quality control The User Manual is digitally printed only on delivery of your machine All information is up to date The ERBE documentation team would like to improve its products for your benefit and I would therefore be very pleased to re ceive suggestions criticism and questions as well as positive comments sS Medical Electrical Equipment es Fle WITH RESPECT TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY C UL US IN ACCORDANCE WITH UL2601 1 CAN CSA C22 2 No 601 1 IEC60601 2 2 19NA EN ISO 9001 EN ISO 13485 User Manual Art No 80104 521 All rights to this User Manual in particular rights of duplication dissemination and translation are reserved No part of this User Manual may be reproduced in any form by photocopying microfilming or other methods or processed duplicat
58. ak voltage 10 watts to 200 watts in 1 watt steps 200 watts 20 75 1166 7 Monopolar Standard Modes 76 1166 Diagrams Power HF output W DRY CUT 250 200 RL 500 Ohm e Effect8 150 ffect7 e ffecto 100 e ffect5 Effect4 Effect e Effect2 50 100 Power HF max W 200 ffect1 Fig 7 7 Power W DRY CUT 100 1000 Resistance Ohm 10000 e Effecta ffect7 e ffect6 fect5 Effect4 Effect3 e Effect2 mo fect1 e Pmax 100W Fig 7 8 80104 521 06 2009 7 Monopolar Standard Modes DRY CUT 1600 1400 e Effect8 1200 e Ef oct7 1000 e Effecto Ss fect5 E 290 Effect4 gt 600 Effect3 de 400 Effect2 em Effect 200 0 0 50 100 150 200 250 Power W Fig 7 9 DRY CUT 80104 521 06 2009 Properties Intense haemostasis with somewhat slower cutting speed Difference compared with Dry Cut Changed ratio of crest factor to RF peak voltage Areas of use E g cuts in open surgery and cuts in endoscopic operations that require very good primary hemostasis during the cut and tolerate a somewhat slower cutting speed Suitable electrodes Electrodes with a large application area knife and spatula electrodes and strap loop electrodes Technical data HF voltage wavefo
59. ally hazard ous situation which if not avoided may result in property damage Meaning of the note Note Refers a to manufacturer s information that relates directly or indirectly to the safe ty of people or protection of property The information does not relate directly to a risk or dangerous situation Refers b to manufacturer s information that is important or useful for operating or servicing the unit 9 166 1 Safety Instructions 10 166 Who must read this User Manual Knowledge of the User Manual is absolutely essential for correct operation of the unit Therefore everyone who is concerned with preparing adjusting operating disassembling as well as cleaning and disinfecting the unit must read the User Manual Please pay particular attention to the safety instructions in each chapter Compliance with safety information Working with medical equipment is associated with certain risks to patients medi cal personnel and the environment Risks cannot be entirely eliminated by design measures alone Safety does not depend solely on the equipment Safety depends to a large extent on the training of medical personnel and correct operation of the equipment The safety instructions in this chapter must be read understood and applied by ev eryone who is working with the equipment Structure of safety instructions The safety instructions are structured according to the following risks 801
60. as short circuited due to an error or a pedal is jammed or a pedal was pressed while the power switch was switched on this error will be indicated acoustically and by an error number and message The relevant error message on the display of the VIO tells you how to remedy the error 80104 521 06 2009 80104 521 06 2009 3 Accessories CHAPTER 3 Accessories You can connect a number of instruments and return electrodes from different man ufactures to the VIO Check ERBE instruments and instruments from other manufacturers for compatibil ity with the required CUT COAG mode of the VIO before use see below Check the return electrodes from other manufacturers for compatibility with the VIO before use see below You can connect only ERBE footswitches to the VIO There are special footswitch es for the VIO D VIO S series and special footswitches for the VIO C series Please note the accessories catalog for ERBE accessories We recommend the use of ERBE accessories Check compatibility of instrument and CUT COAG mode with the help of the Upmax display Electric load on instrument too high The instrument can be damaged If the damaged area comes into contact with tissue it can lead to unintentional coagulation Determine the electrical capacity of the instrument It is either printed on the instrument or can be found in the user manual Compare the electrical capacity of the instrument with the max imu
61. asic prog p Guide Monopolar B 4 Sa receptacle e o Mode Mode 3 gt DRYCUT 2 FORCED COAG lt Effect gt 4 4 max watts gt 180 lt Fig 5 7 The window Cut Coag Settings focuses attention on the functions of a receptacle as you only ever see the CUT settings 1 and COAG settings 2 of one receptacle If you want to check or change the settings of a receptacle call up the receptacle with the appropriate Focus button 3 This also applies to the receptacles of the con nected units For example the CUT COAG settings of the APC 2 are also dis played in this window of the electrosurgical unit Alternatively you can briefly activate the instrument which is connected to the re quired receptacle The display automatically switches to the activated receptacle Pressing the Focus button of the patient plate receptacle will show information about the patient plate on the display The window Cut Coag Settings always appears in combination with the footswitch and Auto Start pilot lamps for the receptacles Further details can be found under the heading Receptacle Selected You can Select CUT 1 and COAG 2 e Change to the window Guide 4 Select a footswitch or Auto Start function 5 for the receptacle Auto Start is however only possible in the bipolar modes In the display cutout 5 all the possible types of activation for the socket depicted are shown The assigned activation type is highlighted in
62. ation is poor the device can overheat sustain damage and fail Install the device in such a way that there is an unobstructed cir culation of air around the housing Installation in confined wall recesses is prohibited Penetration of liquid into the device The housing is not absolutely watertight If liquid penetrates the device can sustain damage and fail Make sure no liquid can penetrate the device Do not place vessels containing liquids on top of the device Electric shock Defective grounded power outlet inferior quality power cord incorrect line voltage multiple power outlets extension cords Risk of electric shock and other injuries to the patient and medical personnel Risk of damage to property Connect the unit the equipment cart to a properly installed grounded power outlet Only use the ERBE power cord or an equivalent power cord for this purpose The power cord must bear the applicable national test symbol Check the power cord for damage You must not use a damaged power cord The supply voltage must match the voltage specified on the unit s rating plate Do not use multiple power outlets Do not use extension cords Incorrect line fuse defective device Risk of electric shock to the patient and medical personnel Risk of damage to property Blown line fuses may only be replaced by a competent techni cian Only replacement fuses that have the same rating
63. best coagulation effect is achieved Modulation BiClamp is a modulated current waveform with alternating pulse and rest periods This ratio is set using Modulation This means the larger the Modulation value the longer the rest period is compared to the subsequent active current flow period Technical data HF voltage waveform modulated sinusoidal alternating volt age Rated frequency 350 kHz at R 500 ohms 10 Crest factor 1 4 at Rj 500 ohms Rated load resistor 25 ohms Max HF peak voltage 220 Vp Number of effects 4 Constancy of effects automatic control of HF peak voltage max HF output 225 watts 111 166 10 Bipolar Optional Modes Diagrams Properties Applications Difference from BIPOLAR CUT 112 166 Suitable electrodes Technical data BiClamp 250 200 x Effect 4 mu Effect 3 m Effect 2 a 100 Effect 1 50 0 10 100 1000 Resistance Ohm Fig 10 1 BIPOLAR PRECISE CUT Very fine adjustment minimal necrosis at the cut edge extremely precise power output in the 1 to 50 W range For example incisions during procedures where stress for the tissue or patient must be minimised e g neurosurgery ENT dermatology In the lower output range you can set the degree of haemostasis to a lower and more precise value Bipolar microsurgical instruments HF voltage waveform Rated frequency C
64. color Determine whether the smoke evacuator is automatically activated 6 with CUT or COAG Changing settings of the Basic Program Here you will change the mode the effect the power limitation e and the activation type 80104 521 06 2009 80104 521 06 2009 5 e Working with the Electrosurgical Unit a Tutorial 1 Call up CUT mode 2 Select CUT mode Call up information on CUT mode Setting Cut mode O Basic prog b aa Monopolar _ receptacle A Mode Mode E DRY CUT FORCED COAG 4 Effect max watts max watts gt 180 80 Fig 5 8 Press the selection button next to the menu item Mode Select cut mode gt o CUT off 4 gt AUTO CUT EHE Ar HIGH CUT gt J DRY CUT Fig 5 9 You will then move to the window Select cut mode On the right you will see a se lection list of modes 1 1 If you press the Up Down button 2 the window scrolls in the selection list The active mode is marked in green To change to other modes if available you can also press the Select button next to the Other modes menu item 3 You will then change to the next window in which the selection list is contin ued When you have reached the end of the selection list by pressing the Select button the next time you press the Select button you will return to the start of the selection list 2 Press the selection button next to the required CUT mode example HIG
65. ction Therefore its HF emis sions are very low in the stand by state and are not likely to cause any interference in nearby electronic equipment HF emissions CISPR 11 Class B The equipment is suitable for use in all establish ments including domestic establishments and those Harmonic emissions TEC 61000 3 2 Class A directly connected to the public low voltage power Voltage fluctuations flicker emissions Complies supply network that supplies buildings used for IEC 61000 3 3 domestic purposes Guidance and manufacturer s declaration electromagnetic immunity The equipment is intended for use in the electromagnetic environment specified below The customer or the user of the equipment should ensure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast tran sient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and volt age variations on power supply input lines IEC 61000 4 11 160 166 IEC 60601 test level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 U 7 gt 95 dip in U 7 for 0 5 cycle 40 U 4 6096 dip in Uy for 5 cycles 710 U 7 3096 dip in U 7 for 25 cycles lt 5 U 4 29596 dip in U 7 for5s Compliance level 6 kV contact x8 kV air 2 kV for power supply lines 1 kV for input output lines
66. d without any danger for the patient e Safety status Red You cannot activate the unit The middle indicator 2 shows the contact resistance as a numerical value Neutral electrode Dual surface setup The diagram on the right 3 shows the con tact resistance as a bar The upper and lower limits of the Green safety status are in dicated by a red line at the top and bottom The lower limit is 20 ohms The upper limit is 120 ohms Neutral electrode Either way setup not illustrated The diagram on the right 3 shows the contact resistance as a bar The upper limit of the Green safety status is indicated by a red line The upper limit is 120 ohms The Neutral electrode Dynamic setup offers extra safety for patients with low skin resistance for example patients with little subcutaneous fatty tissue children and infants Even with these patients critical detachment of the neutral electrode from the skin is detected in good time NESSY dynamic gt lt gt lt gt 4 Tem 4 Fig 2 5 If you press the Focus button on the neutral electrode socket you change to the NESSY window 80104 521 06 2009 2 Safety Features 80104 521 06 2009 You will see a traffic light symbol 1 According to the contact resistance between skin and electrode this symbol shows the following e Safety status Green The unit can be activated without any danger for the patient e Safety status Red You cannot activate
67. device was stored or transported below or above a certain temperature it will take a certain time and temperature to acclima tize If you do not observe the rules the device can sustain damage and fail Acclimatize the device according to the rules in the Technical Data Overheating of the device due to poor ventilation If ventilation is poor the device can overheat sustain damage and fail Install the device in such a way that there is an unobstructed cir culation of air around the housing Installation in confined wall recesses is prohibited Penetration of liquid into the device The housing is not absolutely watertight If liquid penetrates the device can sustain damage and fail Make sure no liquid can penetrate the device Do not place vessels containing liquids on top of the device Electrical installation Defective grounded power outlet inferior quality power cord incorrect line voltage multiple power outlets extension cords Risk of electric shock and other injuries to the patient and medical personnel Risk of damage to property Connect the unit the equipment cart to a properly installed grounded power outlet Only use the ERBE power cord or an equivalent power cord for this purpose The power cord must bear the applicable national test symbol Check the power cord for damage You must not use a damaged power cord The supply voltage must match the voltage specifi
68. dicated by a red line at the top and bot tom The lower limit is 20 ohms The upper limit is not fixed at 120 ohms but de pends on the lowest contact resistance measured between skin and neutral electrode measured value The upper limit is reduced relative to the measured value to en sure that a critical detachment of the neutral electrode from the skin is detected in good time The NESSY window as a visual When you apply a dual surface electrode to the patient s skin first change to the aid to applying a dual surface NESSY window With the aid of its displays you can recognize how good the skin electrode contact is Ideally the contact resistance should be between 20 and 120 ohms The NESSY window when con To check a single surface electrode it is sufficient to observe the indicator lights necting a single surface Similarly in the NESSY window you will only receive the information Safety sta electrode tus Green or Red When a single surface electrode is connected the NESSY window does not give any visual assistance The contact between electrode and skin cannot be measured when a single surface electrode is used Neonatal NE Monitoring System When using Neonatal neutral electrodes you can activate the Neonatal NE Moni toring System You can then turn the Neonatal NE Monitoring System on or off in the NESSY window If an electric current limit of 300 mA is exceeded an advisory message is shown on the VIO display Neonatal NE
69. e 80104 521 06 2009 8 Bipolar Standard Modes Suitable electrodes Bipolar instruments e g bipolar forceps bipolar hook electrodes Technical data 80104 521 06 2009 HF voltage waveform Rated frequency Crest factor Rated load resistor Max HF peak voltage Number of effects Constancy of effects HF power limitation Max power output at rated load resis tor unmodulated sinusoidal alternating voltage 350 kHz at Rj 500 ohms 10 1 4 at Ry 500 ohms 75 ohms 190 Vp 8 automatic control of HF peak voltage 1 watt to 120 watts in 1 watt steps 120 watts 20 BIPOLAR SOFT COAG R 75 Ohm 140 120 e Effect 6 8 m ffect5 ka 109 Effect4 E 80 Effect3 o e Effect2 L r 60 mu ffect1 2 o 40 a 20 0 0 20 40 60 100 120 140 Power HF max W Fig 8 5 95 166 8 Bipolar Standard Modes BIPOLAR SOFT COAG 140 120 e ffect8 m ffect7 100 Effect 80 F ffect5 5 gt Effect4 E 60 Effect3 e ffect2 40 Effect 20 e Pmax 60W 0 10 100 1000 10000 Resistance Ohm Fig 8 6 BIPOLAR SOFT COAG 250 200 e ffect8 e Effect7 em ffecto a 150 gt e Effecto le Effect4 gt 100 Effect3 e Effect2 50 ffect1 0 0 20 40 60 80 100 120 140 Power W Fig 8 7 BIPOLAR SOFT COAG Properti
70. e electromagnetic environment specified below The customer or the user of the equipment should ensure that it is used in such an environment Immunity test TEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile HF commu nications equipment should be used no closer to any part of the equipment including cables than the recommended separa tion distance The separation distance is calculated from vari ous equations depending on the frequency of the portable and mobile HF communications equipment Recommended separation dis tance Conducted HF IEC IV IVe Equation 1 d 1 2 P 61000 4 6 150 kHz to 80 MHz Radiated HF IEC 61000 3 V m 3 V m Equation 2 d 1 2 P 4 3 80 MHz to 800 MHz 3 V m 3 V m Equation 3 d 2 3 P 800 MHz to 2 5 GHz 161 166 18 Information on electromagnetic compatibility EMC Guidance and manufacturer s declaration electromagnetic immunity P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer d is the recom mended separation distance in meters m Field strengths from fixed trans mitters as determined by an electromagnetic site survey should be less than the compli ance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol t9 Note 1 At 80 MHz equation 2 applies At 800 MHz equation 3 applies Note
71. e for return electrode ee 69 Monopolar Standard Modes eese 71 AUTO CUT in eese iie pere ete re ee een ilo a li Ee 71 HIGH CUT cesta sese tion iaia n petet el ay ez des i 73 DRY CUT fig RE INI lela zl ir ica lip N 75 DRY CUT ain ted E 77 SOFT COAG is ili sisi sock idhesiaesdeases tre He a p tee eire err etai 79 SWIET COR Ge Sora nio UB ia uus 81 SWIEL COAG terrenam ail mener te med 83 FORCED COAG aim RIRs ets 85 SPRAY GOAL 87 Bipolar Standard Modes 111rrrrrrreieiiieiiiene 91 BIPOLAR CUT ee ree rti p tO UH ERE eR 9 BIPOLAR CUT i gto ES incepta 93 BIPOLAR SOFT COA Geers ei m rana Seo ei 94 BIPOLAR SOFT COAG E iion eaters Uli eee oe latini 96 BIPOLAR FORCED COAG 6 i e entered massey ayaklarla tues 97 Monopolar Optional Modes eese 101 PRECISE CUT si estes ies e tegit tede ai 101 ENDO CUT Qna teda Een ete et ENE 103 ENDO CUT IE EEE E te he A ile ite da nie a gi 104 80104 521 06 2009 Table of Contents 80104 521 06 2009 10 11 12 13 14 15 16 17 18 19 PRECISE COAG gr ci coro cia Abas eat a i i eni 106 TWIN OA tt diana inni ill celeri ili cela 107 Bipolar Optional Modes srrriiizzzzinioneea 111 BiClampzs5eeent eee ili eta AoE AERE E 111 BIPOLAR PRECISE CUT amaaa Kai yalm utei deo dias 112 BIPOLAR PREGISECOAG alemine
72. e g mobile phones WLAN equipment Electromagnetic waves emitted by portable and mobile HF commu nication devices can effect the unit The unit may fail or not perform properly Please see the table Recommended separation distances be tween portable and mobile HF communications equipment and the equipment at the end of this User Manual Unsuitable temperature or level of humidity during operation If you operate the equipment at an unsuitable temperature or level of humidity it may sustain damage fail or not perform properly Operate the equipment at a suitable temperature and level of hu midity You will find the tolerances for temperature and humid ity in the Technical Data If other ambient conditions must be observed for operation of the equipment you will also find them in the Technical Data Unsuitable temperature or humidity in transit or storage If you transport or store the equipment at an unsuitable temperature or level of humidity it may sustain damage and fail Transport and store the equipment at a suitable temperature and level of humidity You will find the tolerances for temperature and humidity in the Technical Data If other ambient conditions must be observed for transport and storage of the equipment you will also find them in the Techni cal Data 145 166 14 Installation 146 166 Insufficient acclimatization time unsuitable temperature dur ing acclimatization If the
73. e instrument and metal objects in the patient s body Contact with metal hemostats etc Risk of burns to the patient Do not touch metal objects e g implants in the patient s body with the active instrument A hand held metal instrument is touched with the active instrument electrode Risk of hand burns Such practice is not recommended The risk of burns cannot be ruled out 1 Safety Instructions 80104 521 06 2009 Risks due to incorrect use of the return electrode Non compatible or single surface return electrode When applying a non compatible return electrode it should be ex pected that monitoring the contact between return electrode and skin is faulty When applying a single surface return electrode the contact be tween return electrode and skin is not monitored If contact between return electrode and skin is inadequate the unit does not emit any visual and acoustic signal Risk of burns for the patient under the return electrode Checkin the accompanying papers of the manufacturer whether the return electrode is suitable for the VIO device used Use only suitable return electrodes When applying a single surface return electrode Regularly check the return electrode for good skin contact Check in the accompanying papers of the manufacturer whether the return electrode cable is suitable for the return electrode used Use only suitable return electrode cables Po
74. ed on the unit s rating plate Do not use multiple power outlets Do not use extension cords 80104 521 06 2009 14 Installation 80104 521 06 2009 Incorrect line fuse defective device Risk of electric shock to the patient and medical personnel Risk of damage to property Blown line fuses may only be replaced by a competent techni cian Only replacement fuses that have the same rating as the one specified on the unit s rating plate may be used When a fuse has been changed the function of the unit must be verified If the unit does not function properly or if there are any concerns please contact ERBE Damaged device damaged accessories modified device and modified accessories Risk of burns and injury to the patient and medical personnel Risk of damage to property Check the device and accessories for damage every time before using them e g footswitch cords of instruments and the return electrode equipment cart You must not use damaged equipment or damaged accessories Replace defective accessories If the equipment or equipment cart is damaged please contact our customer service For your safety and that of the patient Never attempt to perform repairs or make modifications yourself Any modification will invalidate liability on the part of ERBE Elektromedizin GmbH Grounding If necessary connect the grounding pin of the unit or of the equipment cart to the
75. ed or disseminated by the use of electronic systems without the written consent of ERBE Elektromedizin GmbH The information contained in this User Manual can be changed or expanded without prior notice and without obligation on the part of ERBE Elektromedizin GmbH Printed by ERBE Elektromedizin Printed in Germany Copyright ERBE Elektromedizin GmbH Tiibingen 2009 80104 521 06 2009 Table of Contents Table of Contents Chapter Title Page 1 Safety Instruclti ns onore adamin inte nene lecce ee lees 9 Intended USE iinoa iroa ete pietre I RP UE THERE 9 Combination withothereguipment 9 Safety notations no derent gu ted aee e ee res 9 Meaning of the note te etat eet te eta e nasil ml 9 WhomustreadthisUserManual 10 Compliance with safety information sees 10 Structure of safety instructions eee 10 Operating errors by persons withouttraining 10 Risks due to the environment essere nnne eene eene eene 11 Electtic Shock aset et ero mi tegit bo qe 12 Eire explosion zie EE a Re iiie 13 BS e tee e etu n RE hd e io se li 15 Risks due to incorrect use of the return electrode ss 19 Defective aM 20 Interference caused by the unit essen enne nnne nne 21 Damage to the unit and accessories
76. elec trode is incorrect A check of the connecting cable can be performed before use as follows 25 1166 2 Safety Features Observe the indicator lights No electrode connected Single surface electrode con nected Setup Neutral electrode 26 166 Single surface e Switch on the Unit Set the NESSY setting to NE either way Connect the cable to the return electrode receptacle e If the connecting cord or the clip of a reusable cable do not have shorts the dis play of the dual surface 1 and the display of the single surface 2 will light up red If the displays lights up green a short of the cable is detected by the unit NEUTRAL Fig 2 1 The displays of return electrodes 1 and 2 light up red How do I receive information about the safety status of the return electrode NEUTRAL Fig 2 2 The neutral electrode socket is equipped with indicator lights which represent a dual surface electrode 1 and a single surface electrode 2 respectively Call up the NESSY window using the Focus button Here you can check which setting is active in the unit s service programs 80104 521 06 2009 Neutral electrode Dual surface Neutral electrode Dual surface Neutral electrode Either way Neutral electrode Single surface If the unit is set for a dual surface dynamic electrode and you connect a single sur face electrode the dual surface indicator light will illuminate red
77. eptacle This situation is shown in Fig 5 19 If you activate the instrument on the bipolar receptacle you only see the settings of the bipolar receptacle if you have activated the instrument If in doubt check the settings of the receptacle you want to activate Press the Focus button at the receptacle You can also briefly activate the instrument When doing so persons or objects must not be touched In both cases the window Cut Coag Settings will now display the settings of the receptacle you want to activate You can check the settings NESSY The unit is equipped with a Neutral Electrode Safety System NESSY which mon itors the return electrode neutral electrode warns of critical situations and thus prevents burns How effective the monitoring is depends on whether you choose a single surface or dual surface return electrode and on the NESSY setting On delivery the unit is set to Neutral electrode Dual surface To utilize this setting you require a dual surface neutral electrode In the unit s service programs a technician can carry out various NESSY settings according to your requirements The following table shows you what effects the set tings will have on the safety of monitoring You will see the safety level in the first column 1 highest safety level In the second column you can see the combination of neutral electrode NE setting in the service programs e In columns 3 6 you can see what safety le
78. er advantages this electrode virtually eliminates any possibil trode Either way setup ity of excessive heating of the tissue and skin at the edges of the electrode Contact between skin and electrode If you connect a dual surface electrode the unit not only monitors the connection between unit and electrode but also the contact between skin and electrode If ev erything is OK the electrode symbol illuminates green safety status Green Mo nopolar mode can be activated If the connection with the unit is interrupted or if the contact tab is not fully inserted into the connection clamp or if the contact with the skin is so bad that there is a dan ger of burns the electrode symbol illuminates red safety status Red Monopolar mode cannot be activated If you attempt activation an audible warning signal is emitted Application direction of the contact surface relative to the conduction direction When dual surface electrodes are used NESSY also monitors the direction of ap plication of the contact surface relative to the conduction direction The high fre quency current is not as a rule distributed evenly over the contact surface of the neutral electrode The current flows to the proximal corners or edges There it can be larger than at the distal corners or edges For this reason when applying the neu tral electrode ensure that the neutral electrode s line of symmetry points toward the operating field A Fig 2 3
79. es Lower voltages carbonization of the tissue is prevented adhesion of the electrode to the tissue is reduced considerably Areas of use Coagulation in Bipolar Resection Suitable electrodes On the MF receptacle the mode is restricted by the connecting cords for use with bipolar resectoscopes 96 166 80104 521 06 2009 8 Bipolar Standard Modes 80104 521 06 2009 Technical data Diagrams Properties Areas of use Difference from BIPOLAR SOFT COAG Suitable electrodes Type of HF voltage Unmodulated sinusoidal AC voltage Nominal frequency 350 KHz across Ry 500 ohms 10 Crest factor 1 4 across Ry 500 ohms Design load resistance 75 ohms Max HF peak voltage 190 Vp Number of effects 8 Consistency of effects Automatic control of HF peak voltage Max output across the design load 200 W 20 resistor BIPOLAR SOFT COAG 250 200 F ffect8 ffect7 e F ffect6 150 ffect5 Effect4 amp 100 Effect3 e Effect2 50 effect 0 10 100 1000 10000 Resistance Ohm Fig 8 8 BIPOLAR FORCED COAG lt a Fast bipolar coagulation All bipolar coagulation procedures in which you want to coagulate vessels fast and effectively or want to replace monopolar forceps coagulation Faster bipolar coagulation Carbonization of the tissue cannot be precluded Bipolar instruments e g bipolar forceps bi
80. etup setting Change the setting with the Up Down buttons Press the Enter button to confirm the changed setting 80104 521 06 2009 5 e Working with the Electrosurgical Unit a Tutorial 80104 521 06 2009 Brightness Volume Volume button Viewing angle Power display VIO 300 D Setup Return More Fig 5 38 VIO 300 D Setup Return More Fig 5 39 VIO 300 D Setup Return Fig 5 40 Display of screen brightness in 16 levels Selection of the volume level of the warning signals in 16 levels The warning sig nals must be clearly audible Selection of the button volume in 16 levels Setting of the viewing angle on the display from top from bottom from front If you switch on the output display you will see a bar diagram on activation of the unit 63 166 5 e Working with the Electrosurgical Unit a Tutorial 64 166 Upmax display AUTO START 1 AUTO START 2 Service programs The diagram shows the maximum possible output in the respective mode The green line represents the power limitation If you change the power limitation level the line will move within the bar On activation the bar diagram shows the output level currently called up by the unit under power limitation If it is making full use of the power limitation and you are not satisfied with the cut or coagulation we recommend setting the power limitation to a higher level The nume
81. eutral electrode warns of critical situations and thus prevents burns How effective the monitoring is depends on whether you choose a single surface or dual surface return electrode and on the NESSY setting On delivery the unit is set to Neutral electrode Dual surface To utilize this setting you require a dual surface neutral electrode In the unit s service programs a technician can carry out various NESSY settings according to your requirements The following table shows you what effects the set tings will have on the safety of monitoring You will see the safety level in the first column 1 highest safety level n the second column you can see the combination of neutral electrode NE setting in the service programs e In columns 3 6 you can see what safety level NESSY offers with various com binations Unit NE con Skin NE NE applica Higher safety for patients nection contact tion direction with low skin resistance e e e e e e e e Partial Partial observe warn observe warn ing ing e e With the NESSY setting NE either way setup and a short circuit in the connecting cord or in the clip of a dual surface neutral electrode the device can no longer mon itor the contact with the patient s skin or the application direction of the contact sur face You will not receive a warning if the electrodes becomes detached from the skin You will not receive a warning if the application direction of the neutral
82. genous gases in the gastrointestinal tract Risk of explosion to the patient Extract the gases before performing electrosurgery or irrigate DANGER Combustion supporting gases e g oxygen nitrous oxide The gases can accumulate in materials like cotton wool or gauze The materials become highly flammable Risk of fire to the patient and medical personnel Risk of damage to property Do not use combustion supporting gases when an operation is being performed on the head or thorax Ifuse is unavoidable you must extract the combustion support ing gases before performing electrosurgery 13 166 1 Safety Instructions 14 166 Remove any jeopardized e g cotton wool or gauze materials before performing electrosurgery Check the oxygen carrying tubes and connections for leaks Check the endotracheal tubes and their cuffs for leaks Before using argon plasma coagulation APC in the tracheo bronchial system it is absolutely essential that you observe the specific safety information and instructions in the User Manual for the argon plasma unit Active or hot instruments in contact with combustible materi als Materials like gauze swabs and cloths can catch fire Risk of fire to the patient and medical personnel Risk of damage to property Do not bring active or hot instruments into contact with com bustible materials Put instruments down in a safe place sterile dr
83. grounding system of the operating room using a grounding conductor 147 1166 14 Installation 148 166 gt gt Install electrosurgical unit on overhead support Fig 14 1 For installation you require the VIO fastening set on console No 20180 133 1 Screw the bottom plate to the electrosurgical unit 2 If the electrosurgical unit is installed on an overhead support the caps 1 must be fitted to the interconnections When the unit is activated the interconnec tions carry HF voltage Place the electrosurgical unit on the overhead support In the bottom plate you will see two holes which are provided for the insertion of screws These must match up with the respective holes in the overhead sup port arrows 80104 521 06 2009 3 Firmly screw the electrosurgical unit with the bottom plate to the overhead sup port Meaning of the symbols on the caps WARNING Read the User Manual before removing the caps WARNING HF voltage when the unit is activated 80104 521 06 2009 14 Installation ELEKTROMEDIZIN T BINGEN ofan 2 cf o o0 e o o R Li Fig 14 2 Sockets 1 and 2 footswitch sockets You can connect a one pedal and a two pedal footswitch to these receptacles The two pedal footswitch can be connected to either receptacle 1 or receptacle 2 The same applies to the one pedal fo
84. he connection between unit and electrode but also the contact between skin and electrode If ev erything is OK the electrode symbol illuminates green safety status Green Mo nopolar mode can be activated If the connection with the unit is interrupted or if the contact tab is not fully inserted into the connection clamp or if the contact with the skin is so bad that there is a dan ger of burns the electrode symbol illuminates red safety status Red Monopolar mode cannot be activated If you attempt activation an audible warning signal is emitted Application direction of the contact surface relative to the conduction direction When dual surface electrodes are used NESSY also monitors the direction of ap plication of the contact surface relative to the conduction direction The high fre quency current is not as a rule distributed evenly over the contact surface of the neutral electrode The current flows to the proximal corners or edges There it can be larger than at the distal corners or edges For this reason when applying the neu tral electrode ensure that the neutral electrode s line of symmetry points toward the operating field 53 166 5 e Working with the Electrosurgical Unit a Tutorial Checking function of the NESSY window when a dual surface electrode is connected with Neutral electrode Dual sur face or Neutral electrode 54 1166 Either way setup Fig 5 21 NESSY compares the currents that
85. he frequency of the communications equipment Rated maximum output power Separation distance according to frequency of transmitter m of transmitter W 150 kHz to 80 MHz 80 kHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 pl d 1 2 p d 2 3 pl 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 12 12 23 10 3 8 3 8 7 3 162 166 18 Information on electromagnetic compatibility EMC 80104 521 06 2009 Recommended separation distances between portable and mobile HF communications equipment and the equipment 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance can be deter mined using the equation applicable to the frequency of the transmitter P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the frequency bands between 80 MHz and 2 5 GHz to decrease the likelihood that mobile portable communications equip ment could cause interference if it is inadvertently brought into patient areas Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 163 166 18 Information on electromagnetic compatibility EMC 164 166 80104 521 06 2009 80104 521 06 2009 19 Maintenance C
86. here stress for tissue or patient must be minimised e g neurosurgery ENT dermatology In the lower output range you can set the coagulation degree to a lower and more precise value Bipolar microsurgical instruments HF voltage waveform Rated frequency Crest factor Rated load resistor Max HF peak voltage Number of effects Constancy of effects HF power limitation Max power output at rated load resis tor unmodulated sinusoidal alternating voltage 350 kHz at Rj 500 ohms 10 1 4 at Rj 500 ohms 75 ohms 110 Vp 8 automatic control of HF peak voltage watt to 50 watts in 1 watt steps 50 watts 20 80104 521 06 2009 10 Bipolar Optional Modes 80104 521 06 2009 Diagrams BIPOLAR PRECISE COAG R 75 Ohm 60 e Fffect8 m ffect7 Effect6 El AD I fe ct5 5 Effect4 o 30 Effect 5 20 e Effect2 Effect 10 0 0 20 40 60 Power HF max W Fig 10 5 BIPOLAR PRECISE COAG 60 50 e Effect ffect7 40 e ffecto F ffect5 5 30 Effect4 Effect3 20 e Effect2 ffect1 10 P max 25W 0 10 100 1000 10000 Resistance Ohm Fig 10 6 115 166 10 Bipolar Optional Modes 116 166 BIPOLAR PRECISE COAG 120 100 emu E ffect8 e F ffect7 PEL Effect6 Effect5 u 60 Effecid 2 gt Effect3 e Effec
87. ie Effect3 I 100 Effect2 o 3 feci 50 0 0 100 200 Power HF max W Fig 12 20 SWIFT COAG 250 e E ffect8 200 fiect7 e Effect6 150 F ffect5 5 Effect4 i Effect e Effect2 50 ffect1 a Pmax 100W 0 10 100 1000 10000 Resistance Ohm Fig 12 21 133 166 12 APC Standard Modes Only Available with an APC Module Properties Difference compared with SWIFT 134 166 COAG Applications Suitable electrodes Technical data SWIFT COAG 3000 2500 F ffect8 o Effect7 2000 Effect PEffect5 E 1309 Effect4 2 Effect3 1000 e Effect2 500 e ffect 0 0 50 100 150 200 250 Power W Fig 12 22 Argon assisted SWIFT COAG Mode o Q S o o o o x o o o mum Fast effective coagulation which is very suitable for dissection with high hemostasis due to its limited tissue cutting property Optimised preparation characteristics due to changed ratio of crest factor to RF peak voltage Coagulation and dissection Ball electrodes only for coagulation Knife or blade electrodes for preparation and coagulation Note When using the ERBE VIO APC handpiece a conventional 4 mm electrode can be used instead of the argon applicator For this the flow setting must be set to 0 HF voltage waveform pulse modulated sinusoidal alternat ing voltage Rated frequency 350 kHz at Ry 500 ohms 10 Crest factor 3 5 at Ry
88. ient medical personnel or combustible materials Instruments that have been put down must not come into contact with the patient not even indirectly An instrument can come into contact with the patient indirectly through electrically con ductive objects or wet drapes for example Power setting too high ON time too long effects too high The higher the power setting the longer the ON time of the unit and the higher the effect the higher the risk of accidental tissue damage Risk of accidental tissue damage to the patient s Set power as low as possible relative to the required surgical ef fect However power settings that are too low can be dangerous e g gas embolisms with the APC Argon Plasma Coagulation Activate the unit for as short a time as possible relative to the re quired surgical effect The temperature at the return electrode site increases during long and continuous activations therefore ensure that the cool ing phases between activations are sufficient Set effect as low as possible relative to the required surgical ef fect If you are unable to achieve a surgical effect with a power set ting ON time effect level that is sufficient judging from expe rience this can be due to a problem with the electrosurgical unit Or accessories Check the instrument for soiling with insulating tissue rem nants Check the return electrode to make sure it is secure Check the connecto
89. inated with blood before using the disinfectant otherwise it may be less effective Wipe the surfaces Make sure the surfaces are treated uniformly Comply with the action time of the disinfectant specified by the manufacturer Safety Instructions Connection of unit equipment cart and power supply during cleaning and disinfection Risk of electric shock to the medical personnel Switch off the device Unplug the power cord of the device equipment cart Flammable detergents and disinfectants flammable solvents in adhesives used on the patient and on the device equip ment cart Risk of fire and explosion to the patient and medical personnel Risk of damage to property Use products that are not flammable If the use of flammable products is unavoidable proceed as fol lows Allow the products to evaporate completely before switching on the device Check whether flammable liquids have accumulated under the patient in body recesses such as the navel or in body cavities such as the vagina Remove any liquids before performing elec trosurgery 151 166 15 Cleaning and Disinfection Membrane keyboards 152 166 Penetration of liquid into the device The housing is not absolutely watertight If liquid penetrates the device can sustain damage and fail Make sure no liquid can penetrate the device Do not place vessels containing liquids on top of the device Alcohol based spray dis
90. infectant for fast disinfection With membrane keyboards and paint surfaces there is the risk of cracks Propanol and ethanol will erode surfaces Do not use these substances Alternate use of disinfectant solutions based on different active ingredients A color reaction may occur with plastics Do not use these substances alternately Note If alcohol based disinfectants are used on units with membrane keyboards this remove the anti glare finish However the user surfaces remain fully functional This does not present a hazard 80104 521 06 2009 80104 521 06 2009 16 Status Messages Error Messages An error message consists of an error code and an error text The display of the VIO system shows two different types of error messages a Error messages that prompt you to take action and remedy the error You will find these error messages in the table b Error messages that prompt you to inform Technical Service These error mes sages are not listed individually in the User Manual because the error texts of the relevant error codes are constantly repeated The error texts are e Activation has been interrupted due to an error If the error recurs please inform Technical Service Minor deviation from the system parameters If this message is repeated please inform Technical Service Status Messages B 84 Connected two pedal footswitch ready for operation B 85 Two pedal footswitch disconnected fr
91. ing errors the front panel and the menus are designed so as to au tomatically monitor and signal illogical or incomplete settings All receptacles of the applied part are arranged in the receptacle strip next to the front panel These receptacles are designed so that only connectors of the proper ac cessories can be inserted provided that only the accessories supplied or recom mended by the manufacturer of the unit are used You can connect three instruments simultaneously to the unit However for safety reasons they can only be activated alternately HF voltage is only ever carried by one receptacle TWIN COAG mode is an exception to this Whenever the power switch is switched on an automatic test program is run inside the unit designed to detect and signal the following defects in the operator controls of the unit and the connected accessories e Ifa button on the front panel has short circuited due to an error or was pressed when the power switch was switched on this error will be indicated acousti cally and by an error number and message after switch on of the power switch e Ifa button on the electrode handle has short circuited due to an error or has been bypassed at low resistance e g due to moisture in the electrode handle or was pressed while the power switch was switched on this error will be indi cated acoustically and by an error number and message after switch on of the power switch e Ifa contact of the footswitch h
92. ing the automatic start stop mode Testing the spark monitor Measurement of the output power in the CUT and COAG operating modes Functional testing of the upgrades The results of the safety checks must be documented If during the safety checks any defects are found which might endanger patients staff or third parties the device may not be operated until the defects have been rem edied by competent service technicians Customer service If you are interested in a maintenance contract please contact ERBE Elektromediz in in Germany or your local contact in other countries This may be an ERBE sub sidiary an ERBE representative or a distributor Warranty The General Terms and Conditions or the conditions of the purchase contract apply 165 166 19 Maintenance Customer Service Warranty Disposal 166 166 Disposal Your product bears a crossed out garbage can icon see image Meaning In all EU countries this product must be disposed of separately in accordance with the nation al laws implementing EU Directive 2002 96 EC of January 27 2003 WEEE In non EU countries the local regulations must be observed If you have any questions about disposal of the product please contact ERBE Ele ktromedizin or your local distributor 80104 521 06 2009
93. ings of the active program Superimposed on the window Guide you will see a small window with the message Check settings before activating Please confirm by pressing key Only when you have complied with this prompt will you have access to the active program and the functions of the window Guide After switch on the unit always calls up the program you last used This does not apply to ReMode programs See here p 58 In the sample program the bipolar re ceptacle is assigned with the following settings 80104 521 06 2009 5 Working with the Electrosurgical Unit a Tutorial 80104 521 06 2009 Cut mode BIP CUT e Cut effect 4 e Cut power limitation 60 W e Coag mode BISOFT e Coag effect 4 e Coag power limitation 60 W If your unit is equipped with a patient plate receptacle the display of the receptacle will show a patient plate 4 If you have connected an APC 2 an IES 2 or another unit to the electrosurgical unit you can also find out about the assignment of the other unit receptacles in the pro gram The sample display shows the symbol of the Down button 5 Underneath you can see APC An APC 2 is connected to the electrosurgical unit If you press the Down button on the front panel of the electrosurgical unit the window scrolls down to the APC receptacles 4 Getting an overview assign ment of the active program for Guide program xy the APC2 T O Select APC Buchse b program fina DRY
94. ion PPS Power Peak System The BIPOLAR CUT mode is equipped with PPS A special problem during incision may be posed by the initial incision phase in particular when the cutting electrode is pressed firmly against the tissue to be cut before activation of the HF generator so that the cutting electrode has a relatively extensive and thus low resistance contact with the tissue This is generally the case for example with TUR and endoscopic polypectomy In such cases the HF generator must offer an above average output so that the initial incision is not delayed as otherwise an excessive coagulation necro sis may be produced at the point of initial incision The VIO is equipped with auto matic power control which detects low resistance loads and controls the HF gener ator so that it briefly provides sufficient output to ensure the HF voltage necessary for the cutting quality selected or the intensity of the electric arcs even with low re sistance loads Thanks to this feature the average output can be limited to relatively low levels something which represents improved protection from unintentional thermal tissue damage Suitable electrodes On the MF receptacle the mode is restricted by the connecting cords for use with bipolar resectoscopes Technical data Type of HF voltage Unmodulated sinusoidal AC voltage Nominal frequency 350 kHz across Ry 500 ohms 1096 Crest factor 1 4 across Ry 500 ohms 93 166 8 Bipolar Standard M
95. ion is not delayed as otherwise an excessive coagulation necro sis may be produced at the point of initial incision The VIO is equipped with auto matic power control which detects low resistance loads and controls the HF gener ator so that it briefly provides sufficient output to ensure the HF voltage necessary for the cutting quality selected or the intensity of the electric arcs even with low re sistance loads Thanks to this feature the average output can be limited to relatively low levels something which represents improved protection from unintentional thermal tissue damage Areas of use Several including cutting fat containing structures cutting under water e g with TUR P Suitable electrodes Knife spatula and loop electrodes Technical data HF voltage waveform unmodulated sinusoidal alternating voltage Rated frequency 350 KHz at R 500 ohms 10 Crest factor 1 4 at R 500 ohms 73 1166 7 Monopolar Standard Modes 74 1166 Diagrams Rated load resistor Max HF peak voltage Number of effects Constancy of effects HF power limitation 500 ohms 950 Vp with an arc 8 automatic control of arc intensity 10 watts to 300 watts in 1 watt steps Max power output at rated load resis 300 watts 20 tor HIGH CUT R 500 Ohm 350 300 PN e Effect 1 8 250 5 8 200 2 o E 150 g 3 100 a 50
96. lectrodes Knife and lancet shaped electrodes Technical data HF voltage waveform Rated frequency Crest factor Rated load resistor Max HF peak voltage Number of effects Constancy of effects HF power limitation Max power output at rated load resis tor pulse modulated sinusoidal alternat ing voltage 350 KHz at Rj 500 ohms 10 7 4 at Ry 500 ohms 500 ohms 4300 Vp 2 Restriction of HF peak voltage 5 watts to 120 watts in 1 watt steps 120 watts 20 87 i166 7 Monopolar Standard Modes 88 166 Diagrams 140 120 100 80 60 40 Power HF output W 20 SPRAY COAG R 500 Ohm ffect 1 2 0 50 100 150 Power HF max W Fig 7 25 140 120 100 80 60 Power W 40 20 SPRAY COAG Effect2 e Effect Eff2 Pmax 60W Eff Pmax 60W 10 100 1000 10000 Resistance Ohm Fig 7 26 80104 521 06 2009 7 Monopolar Standard Modes 80104 521 06 2009 SPRAY COAG 5000 4500 4000 3500 3000 2500 2000 1500 1000 500 Effect2 ffect1 U HF Vp 0 20 40 60 80 100 120 140 Power W Fig 7 27 89 166 7 Monopolar Standard Modes 90 166 80104 521 06 2009 80104 521 06 2009 8 Bipolar Standard Modes CHAPTER 8 Bipolar Standard
97. lights will illuminate red It is not possible to activate monopolar mode Single surface electrode con If you connect a single surface electrode the unit only monitors the connection be nected Setup Neutral electrode tween unit and electrode If this is faultless the electrode symbol illuminates green Single surface safety status Green Monopolar mode can be activated If the connection to the unit is interrupted or if the electrode contact tab is not fully inserted into the connection clamp the electrode symbol illuminates red safety sta tus Red Monopolar mode cannot be activated If you activate the device despite the warning an audible warning signal is emitted If a single surface electrode is con nected the contact between the electrode and the patient s skin is not monitored You will not receive a warning if the electrode becomes detached from the skin and there is a danger of burns Dual surface neutral electrode To optimally utilize the unit s monitoring functions ERBE recommends connecting connected Neutral electrode a dual surface electrode and in particular the ERBE NESSY Omega electrode Dual surface or Neutral elec Apart from many other advantages this electrode virtually eliminates any possibil trode Either way setup ity of excessive heating of the tissue and skin at the edges of the electrode Contact between skin and electrode If you connect a dual surface electrode the unit not only monitors t
98. lypectomy In such cases the HF generator must offer an above average output so that the initial incision is not delayed as otherwise an excessive coagulation necro sis may be produced at the point of initial incision The VIO is equipped with auto matic power control which detects low resistance loads and controls the HF gener ator so that it briefly provides sufficient output to ensure the HF voltage necessary for the cutting quality selected or the intensity of the electric arcs even with low re sistance loads Thanks to this feature the average output can be limited to relatively low levels something which represents improved protection from unintentional thermal tissue damage Areas of use All cutting procedures in electrically conductive tissue e g muscle tissue and vas cular tissue Dissections and cutting of fine structures Suitable electrodes Needle electrodes knife electrodes spatula electrodes loop electrodes Technical data HF voltage waveform Rated frequency Crest factor Rated load resistor Max HF peak voltage Number of effects Constancy of effects HF power limitation Max power output at rated load resis tor unmodulated sinusoidal alternating voltage 350 kHz at RL 500 ohms 10 1 4 at RL 500 ohms 500 ohms 740 Vp 8 automatic control of HF peak voltage 10 watts to 300 watts in 1 watt steps 300 watts 20 71 1166 7 Monopolar Standard Modes 72 1166 Diagrams
99. m HF peak voltage of the required mode Observe the following instructions 1 Switch on the Upmax display If the Upmax display is not visible in the Cut Coag Settings window you must switch on the Upmax display Call up the Guide window Select the Other functions menu item Select the Setup menu item Press the selection button next to the More menu item Use a selection button to select Upmax Change the setting to ON using the Up Down buttons Press the Enter button to confirm the changed setting 2 Determine the electrical The maximum electrical capacity of the instrument is indicated on the instrument or capacity of the instrument in the users manuals of the instruments The unit of measurement for electrical ca pacity is Vp For example an instrument can have a maximum electrical capacity of 5 kVp 5000 Vp Another instrument can have a maximum electrical capacity of 500 Vp You are not permitted to load the instrument beyond these values Example You want to operate an instrument with a maximum electrical capacity of 500 Vp You want to operate the instrument in AUTO CUT mode and with Effect 8 Look at the Upmax display in the Select Cut Effect window 31 166 3 Accessories 3 Call up the Select Cut Effect window b Guide prozia Monopolar receptacle Mode gt AUTO CUT Fig 3 1 gt Press the selection button next to the Effect menu item Select Cut Effect gt lt AUTO CU
100. ms 1 1 If you press the Up Down buttons 2 and more than 4 programs are stored the window scrolls in the program selection list The active program is marked in green 2 Pressthe selection button next to the reguired program For the purpose of this exercise please select the Basic Program 3 Accept selected program Guide 0 Basic program b Adopt ec receptacle 4 program na CUT Pei ec sow kra Gow Select p EE receptacle program DRY 5d 4 4 p EE 5d sow O 300 D d UN Em Bo E E 4 Fig 5 6 You have now returned to the window Guide and can find out about assignment of the active program see Assignment of the active program 40 If you want to accept the selected program press the selection button next to the menu item Adopt Program You will then move to the window Cut Coag Settings You will then see the settings of the receptacle last activated The Focus button next to this receptacle is lit up Alternatively you can press the selection button next to a receptacle display e g the selection button next to the monopolar receptacle With this action you will like wise accept the program 43 166 5 e Working with the Electrosurgical Unit a Tutorial The window Cut Coag Settings What can I do in the window Cut 44 1166 Coag Settings The basic concept of the electrosurgical unit focusing attention on the functions of a receptacle Focus View O B
101. n is pos sible Please end activation Footswitch or fingerswitch activation detected during device start up Program memory full Please delete programs no longer needed Double activation Two switches pressed simultaneously e g footswitch and fingerswitch Line voltage fault The unit has discontinued activation due to an insufficient supply voltage If this recurs please inform Technical Service Invalid BMP file Inform Technical Service Please end activation Please remove forceps from tissue After which reactivation is possible Invalid system component The connected component is not compatible with the VIO system Inform Technical Service Self check active Please wait until self check is complete The unit is then ready for use ON time limitation Maximum ON time exceeded Maximum ON time can be adjusted in setup Instrument detection fault Do not use instrument have it checked Pressed button detected Button pressed on device during start up Release button If fault cannot be rem edied inform Technical Service NESSY symmetry When applying neutral electrode patient plate ensure that neutral electrode line of symmetry runs towards the operating field VIO socket 1 fault restart VIO If fault cannot be remedied inform Technical Service VIO socket 2 fault Restart VIO If fault cannot be remedied inform Technical Service 80104 521 06 2009 VIO socket 3 fault Restart VIO If fault cannot be remedied info
102. ndow Guide Here you can see the number 1 and the name 2 of the active program In this ex ample it is the program program xy On the right side of the window you can see the assignment 3 of the active pro gram The receptacles of your individual unit are displayed schematically This pro vides you with answers to the questions Which CUT COAG mode which effect what capacity are active for which receptacle You now have two options for activating CUT or COAG for a receptacle of the pro gram Option 1 Direct activation from the window Guide It is not possible to assign a footswitch to a receptacle here You can activate all receptacles with a fingerswitch With a footswitch you can only activate the CUT or COAG mode for a receptacle which was allocated a footswitch in the program The allocation of the footswitches in this view can be seen from the illuminated footswitch symbols of the receptacles Option 2 You press the selection button next to the menu item Adopt Program switch to the window Cut Coag Settings and effect activation from this window The window Cut Coag Settings focuses attention on the functions of a receptacle In the window Cut Coag Settings any allocation of the footswitches is possible Ac tivation using a fingerswitch is possible The use of the window Cut Coag settings is described in detail from p 44 In both cases you first have to confirm by pressing any button that you have checked the sett
103. nitoring electrodes that contain devices to limit high frequency current 15 166 1 Safety Instructions 16 166 HF leakage current flows through skin to skin points of con tact HF current can be discharged through skin to skin points of contact accidentally HF leakage current Risk of burns to the patient Prevent skin to skin points of contact For example lay dry gauze between the patient s arms and body Unintentional activation of the instrument Risk of burns to the patient and medical personnel Put instruments down in a safe place sterile dry non conduc tive and easy to see Instruments that have been put down must not come into contact with the patient medical personnel or combustible materials Instruments that have been put down must not come into contact with the patient not even indirectly An instrument can come into contact with the patient indirectly through electrically con ductive objects or wet drapes for example Hot instruments Even non active instruments that are still hot can burn the patient or medical personnel Put instruments down in a safe place sterile dry non conduc tive and easy to see Instruments that have been put down must not come into contact with the patient medical personnel or combustible materials Instruments that have been put down must not come into contact with the patient not even indirectly An instrument can come into con
104. nterval makes it easier to 103 166 9 Monopolar Optional Modes 104 166 Technical data Diagrams Properties Areas of use Suitable electrodes remove the lesion guickly A long cutting interval makes it easier to remove the le sion slowly under control HF voltage waveform Rated freguency Crest factor Max HF peak voltage Number of effects Constancy of effects Max power output unmodulated sinusoidal alternating voltage 350 kHz at Rj 500 ohms 10 1 4 at Rj 500 ohms 770 Vp 4 automatic control of HF peak voltage 400 watts 0 20 ENDO CUT Q gt Cutting stage max 450 Power 400 Cutting stage min amp Power 350 300 250 200 150 100 50 0 MN 10 100 1000 10000 Resistance Ohm Fig 9 4 ENDO CUT I The cut consists of alternating cutting and coagulating phases The cut is easy to control and is characterized by a reproducible preselectable coagulation property while cutting Endoscopic interventions in which alternating cutting and coagulation with activa tion is called for Papillotomy needle electrodes 80104 521 06 2009 9 Monopolar Optional Modes 80104 521 06 2009 Expert mode For a customized setting you can have Expert mode activated by a service techni cian The Cut Coag Settings window will then also show the parameters Cutting duration and Cutting inter
105. ntrol of HF peak voltage HF power limitation 5 watts to 200 watts in watt steps Max power output at rated load resis 200 watts 20 tor 83 166 7 Monopolar Standard Modes 84 166 Diagrams SWIFT COAG R 500 Ohm 250 _ 200 e Effect 7 8 F ffect6 5 ffect5 g 150 Effect a Effect3 T 100 E fect2 o 3 F ffect1 50 0 0 100 200 Power HF max W Fig 7 19 SWIFT COAG 250 e Fffect8 200 effect e ffecto 150 F ffect5 5 Effect4 160 Effect3 e Effect2 A ffect1 a Pmax 100W 0 10 100 1000 10000 Resistance Ohm Fig 7 20 80104 521 06 2009 7 Monopolar Standard Modes 80104 521 06 2009 SWIFT COAG 3000 2500 co ffect8 e ffoct7 _ 2000 ftect6 Effoct5 ri 1590 Efeci4 2 Effect3 1000 c Effect2 500 e Effect 0 0 50 100 150 200 250 Power W Fig 7 21 FORCED COAG 4 Properties Effective fast standard coagulation Areas of use Contact coagulation clamp coagulation e g with insulated monopolar forceps Difference from SWIFT COAG The tissue cutting property is suppressed Suitable electrodes Ball electrodes for coagulation Insulated monopolar forceps for clamp coagulation Technical data I HF voltage waveform pulse modulated sinusoidal alternat ing voltage Rated frequency 350 KHz at
106. od Notes Grounding Note If necessary the equipment can be connected to the external grounding sys tem of the room with the grounding pin on the back of the unit and or Cart using a connecting cable designed for this purpose Affects of low frequency leakage cur rents due to a defective grounding system within the room may be eliminated through external grounding Use of a defibrillator Note The equipment conforms to the requirements of Type CF and is protected against the effects of a defibrillator discharge Membrane keyboards Note If alcohol based disinfectants are used on units with membrane keyboards this remove the anti glare finish However the user surfaces remain fully functional This does not present a hazard 23 166 1 Safety Instructions 24 1166 80104 521 06 2009 80104 521 06 2009 2 Safety Features CHAPTER 2 Safety Features What is NESSY The NESSY settings 1 Dual surface NE setting NE Dynamic 2 Dual surface NE setting NE Dual surface 3 Dual surface NE setting NE Either way 4 Single surface NE setting NE Either way 4 Single surface NE setting NE Single surface Short circuit in the connecting cord or in the clip of a dual sur face neutral electrode with the NESSY setting NE either way setup NESSY The unit is equipped with a Neutral Electrode Safety System NESSY which mon itors the return electrode n
107. odes 94 1166 Diagrams Properties AUTO STOP AUTO START Design load resistance 500 ohms Max HF peak voltage 770 Vp Number of effects 8 Consistency of effects Automatic control of HF peak voltage Max output across the design load 370 W 20 resistor BIPOLAR CUT e ffect8 ffect7 ffect6 fect5 Effect4 E Effect3 a e Effect2 foct1 100 1000 10000 Resistance Ohm Fig 8 4 BIPOLAR SOFT COAG ALA Lower voltages carbonization of the tissue is prevented adhesion of the electrode to the tissue is very much reduced If you want to use the potentially high coagulation intensities of BIPOLAR SOFT COAG to the full select a low effect level and carry out coagulation for a longer period If you are only able to carry out coagulation for a short time select a high effect level You will then still achieve a high coagulation intensity in comparison with other COAG modes but do not use the potential coagulation intensity of BI POLAR SOFT COAG to the full The BIPOLAR SOFT COAG mode is also available as BIPOLAR SOFT COAG with AUTO STOP AUTO STOP ends activation automatically before the tissue ad heres to the instrument In the window Select activation type you can select an AUTO START function for BIPOLAR SOFT COAG When the instrument touches tissue coagulation starts automatically after a specified period of tim
108. of a system Every electrosurgical system is put to ured system gether individually for you This variability involves the receptacles the software and also the combination with other units which can be connected to the electrosur gical unit There are separate user manuals for the units which are available for the combinable units and for the VIO CART The tutorial is based on a sample In this tutorial you will learn how to operate the VIO 300 D electrosurgical unit us configuration ing a sample configuration Although the unit you have before you may be config ured differently the structure of the user environment and operation of the functions is nevertheless identical As with a computer program you can call up a series of windows in the user envi ronment of the unit In a window you can carry out a series of actions You do not have to call up the windows and carry out the actions in a specific sequence This depends on what you wish to achieve A tutorial normally specifies a procedure for this reason it can only act as an example Operation is intuitive and simple The tutorial puts forward a task and describes the solution ERBE recommends to learn learning the different steps on the unit Then think of a typical work situation orga nize the receptacles according to your requirements for example and save a pro gram If you get stuck with the settings in a window consult the tutorial Learning by doing is the fastest way to learn
109. olar forceps Tissue cutting property is suppressed Ball electrodes for contact coagulation Insulated monopolar forceps for clamp co agulation Note When using the ERBE VIO APC handpiece a conventional 4 mm electrode can be used instead of the argon applicator For this the flow setting must be set to 0 HF voltage waveform Rated frequency Crest factor Rated load resistor Max HF peak voltage Number of effects Constancy of effects HF power limitation Max power output at rated load resis tor pulse modulated sinusoidal alternat ing voltage 350 kHz at R 500 ohms 10 6 0 at Rj 500 ohms 500 ohms 1800 Vp 4 automatic control of HF peak voltage 5 watts to 120 watts in watt steps 120 watts 20 80104 521 06 2009 12 APC Standard Modes Only Available with an APC Module 80104 521 06 2009 Diagrams FORCED COAG R 500 Ohm 140 120 Jan gt Effect 3 4 bei Effect 2 2 80 ffect1 3 t 60 o 40 a 20 0 0 50 100 150 Power HF max W Fig 12 26 FORCED COAG 140 120 199 Effect S 80 Effect3 S e Effect2 60 ffect1 bp max 60W 40 20 0 10 100 1000 10000 Resistance Ohm Fig 12 27 137 166 12 APC Standard Modes Only Available with an APC Module 138 166 Properties Areas of Use Suitable electrodes Technical data FORCED
110. om system B 88 Single pedal footswitch ready for operation B 89 Single pedal footswitch disconnected from system B 93 Multifunctional footswitch ready for operation B 94 Multifunctional footswitch disconnected from system B 95 Connected instrument ready for operation It has already been used approx xxx times B A6 Data transmission Transferring data to program memory Please wait until system has been restarted B 9B Remote control VIO system disconnected from an external master unit and ready for operation B 9C Remote control VIO system disconnected from external master unit B 9D Remote control VIO system controlled by external remote control and ready for operation B 9E Remote control VIO system disconnected from external remote control B 9F Instrument disconnected from VIO system B B Nessy contact Please check contact between skin and neutral electrode patient plate B F Keyboard fault The selection buttons are defective If this message reappears please inform Technical Service B 01 Fault Restarting device due to fault B 09 Fault Restarting device due to fault 153 166 16 Status Messages Error Messages Error Messages B 10 B 12 B 16 B 17 B 19 B 21 B 22 B 81 B 1B B 1C B 1D B 1E B 8E B 8F B 90 B 97 B 98 B 99 B 9A B A0 B A3 B A4 B A8 B A9 B AA B AB 154 166 Please end activation Activation via finger or footswitch must be ended After which reactivatio
111. on of the Controls CHAPTER 4 Description of the Controls Controls on the front panel O Basic Guide progs Mode DRY CUT BIPOLAR MONOPOLAR Monopolar receptacle Mode FORCED COAG Effect max watts 180 Fig 4 1 Power Symbol Adjustment buttons Focus buttons v E Effect max watts NEUTRAL 1 Power switch Unit on off 1a Read the user manual before switching on and using the unit 10 Up down These buttons always have a function when they appear in the display For example the buttons are used to select the effect 11 Enter Confirms a setting accepts a selection saves a setting You can combine the unit receptacles in any way required In this regard Fig 4 1 is only one example of a configuration If a Focus button next to the receptacle is pressed the functions of the receptacle and the setting of the functions will be shown in the display 12 Focus button for bipolar receptacle 13 Focus button for monopolar receptacle 14 Focus button for MF receptacle 15 Focus button for patient plate receptacle Shows info about the patient plate on the display 35 166 4 Description of the Controls 36 166 Pilot lamps Symbol Symbol Selection buttons 16 Footswitch The footswitch symbol lights up when the respective footswitch is assigned to the scoket 17 Auto Start When this lamp is lit up Auto Start is active
112. ontact be tween return electrode and skin is inadequate the unit does not emit any visual and acoustic signal Risk of burns for the patient under the return electrode Check in the accompanying papers of the manufacturer wheth er the return electrode is suitable for the VIO device used Use only suitable return electrodes When applying a single surface return electrode Regularly check the return electrode for good skin contact Check in the accompanying papers of the manufacturer wheth er the return electrode cable is suitable for the return electrode used Use only suitable return electrode cables Depending on the return electrode single surface or dual surface and the settings in the service programs the return electrode safety system NESSY of the VIO monitors various parameters for ERBE and compatible return electrodes e Theunit retum electrode connection e The skin return electrode contact The application direction of the return electrode Get to know what specific parameters are monitored in the Safety Features chap ter When using single surface return electrodes the skin return electrode contact is not monitored When using third party return electrodes you must check in the accompanying pa pers of the manufacturer whether the return electrode is suitable for the VIO used 33 166 3 Accessories 34 1166 80104 521 06 2009 80104 521 06 2009 4 Descripti
113. operties Very fine adjustment minimum necroses at the cut edge very fine power output in a range of 1 to 50 watts Areas of use E g cuts in operations where strain on the tissue or patient must be kept to a mini mum e g neurosurgery ENT dermatology Difference from AUTO CUT In the lower power range you can set the degree of hemostasis lower and more ac curately Suitable electrodes Microsurgical instruments needle electrodes for microsurgery Technical data HF voltage waveform unmodulated sinusoidal alternating voltage Rated frequency 350 kHz at R 500 ohms 10 Crest factor 1 4 at Rj 500 ohms Rated load resistor 500 ohms Max HF peak voltage 390 Vp Number of effects 8 Constancy of effects automatic control of HF peak voltage HF power limitation 1 watt to 50 watts in 1 watt steps Max power output at rated load resis 50 watts 20 tor 101 166 9 Monopolar Optional Modes 102 166 Diagrams PRECISE CUT R 500 Ohm 60 DE s0 e Effect 2 8 T Effect 2 2 2 o 30 L Tr 20 o a 10 0 0 10 20 30 40 50 60 Power HF max W Fig 9 1 PRECISE CUT e Effect8 ffect7 e Fffecto F ffect5 5 Effect4 Effect3 e Effect2 ffect1 100 1000 Resistance Ohm 10000 eee P max 25W Fig 9 2 80104 521 06 2009 9 Monopolar Optional Modes 80104 521 06 20
114. orial Setting CUT effect Fig 5 11 O Basic prog iced Monopolar i receptacle Mode Mode HIGH CUT FORCED COAG T TUNE Effect max watts 180 max watts Press the selection button next to the menu item Effect A 80104 521 06 2009 5 e Working with the Electrosurgical Unit a Tutorial 80104 521 06 2009 2 Choose CUT Effect 1 Call up Cut Power limitation Select Cut Effect HIGH CUT A E a v v i DI a o Ga You will then move to the window Select Cut Effect You will see a numerical display for the effect 1 and a display in the form of a bar A picture 3 shows the consequence of the effect on tissue Select an effect with the Up Down buttons 4 example Cut Effect 4 Confirm your selection by pressing the Enter button 5 or by pressing the selection button next to the menu item Return You will then move back to the window Cut Coag Settings Selecting CUT Max Wattage O Basic prog Gulda Monopolar EL E progs receptacle Mode Mode HIGH CUT gelok 4 47 lt 180 80 Press the selection button next to the menu item max watts 47 1166 5 e Working with the Electrosurgical Unit a Tutorial 2 Select Cut power limitation 48 166 Footswitch concept Cut power limitation Monop receptacle gt HIGH CUT 300 lt Effect 4 gt A ur Lio PI max watts gt v 4 0 gt Return Info 4 Fig 5
115. otswitch 3 ECB sockets ECB means ERBE Communication Bus You can connect other units to the electrosurgical unit e g an APC or a smoke evacuator The electrosurgical unit then functions as a control unit whose display shows the functions of the other units The ECB ensures communication between the units Connect an ECB cable to this socket and connect it to one of the other units Grounding 4 Grounding terminal Connect a grounding cable and connect this to the grounding system of the operating room Power connection 5 Power connection Connect the unit to a properly installed grounded outlet Only use the ERBE power cord or an equivalent power cord for this purpose The power cord must bear the na tional test symbol Installing the unit on an ERBE equipment cart Please read the User Manual for the equipment cart concerned There you will find instructions on how to secure the unit to the equipment cart 149 166 14 Installation 150 166 80104 521 06 2009 80104 521 06 2009 15 Cleaning and Disinfection CHAPTER 15 Cleaning and Disinfection Wipe disinfection For cleaning and disinfecting the surfaces of the unit or of the equipment cart ERBE recommends a wipe disinfection Use only disinfectant which complies with the rel evant national standards Instructions for cleaning and disinfection Mix the disinfectant in the concentration specified by the manufacturer Clean surfaces contam
116. pment or system experiencing disturbance When the VIO electrosurgical unit is in the non activated state interference with other equipment in the immediate vicinity does not occur Use of non approved internal cables by Technical Service This can result in the increased emission of electromagnetic waves or reduce the immunity of the device The unit may fail or not perform properly Technical Service may only use the internal cables that are list ed in the service manual for the device Stacked devices If you stack the device next to other equipment or with other equip ment the devices can affect each other The unit may fail or not perform properly The device may only be stacked next to or with VIO series units If it is necessary to operate the device near other equipment or stacked together with other equipment check whether the de vices are affecting each other Are the devices behaving unusu ally Do errors occur 159 166 18 Information on electromagnetic compatibility EMC Guidance and manufacturer s declaration electromagnetic emissions The equipment is intended for use in the electromagnetic environment specified below The customer or the user of the equipment should ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance HF emissions CISPR 11 Group 1 In the stand by state the equipment uses HF energy only for its internal fun
117. polar hook electrodes 97 1166 8 Bipolar Standard Modes 98 166 Technical data Diagrams HF voltage waveform Rated frequency Crest factor Rated load resistor Max HF peak voltage Number of effects Constancy of effects HF power limitation Max power output at rated load resis tor pulse modulated sinusoidal alternat ing voltage 350 KHz at Ry 500 ohms 10 4 4 at R 500 ohms 200 ohms 560 Vp 2 automatic control of HF peak voltage 5 watts to 90 watts in 1 watt steps 90 watts 20 BIPOLAR FORCED COAG 100 R 200 Ohm 90 80 70 feci 1 2 60 50 40 30 Power HF output W 20 0 20 40 60 80 100 Power HF max W Fig 8 9 80104 521 06 2009 8 Bipolar Standard Modes 80104 521 06 2009 BIPOLAR FORCED COAG 100 90 80 70 60 50 40 30 20 10 ffect 1 2 P max 50W Power W 10 100 1000 10000 Resistance Ohm Fig 8 10 BIPOLAR FORCED COAG 600 500 400 ffect 2 e Effect 1 300 U HF Vp 200 100 0 20 40 60 80 100 Power W Fig 8 11 99 166 8 Bipolar Standard Modes 100 166 80104 521 06 2009 80104 521 06 2009 9 Monopolar Optional Modes CHAPTER 9 Monopolar Optional Modes PRECISE CUT mmm pe Pr
118. rest factor Rated load resistor Max HF peak voltage Number of effects Constancy of effects HF power limitation Max power output at rated load resis tor unmodulated sinusoidal alternating voltage 350 kHz at Ry 500 ohms 10 1 4 at Rj 500 ohms 500 ohms 390 Vp 8 automatic control of HF peak voltage 1 watt to 50 watts in 1 watt steps 50 watts 20 80104 521 06 2009 10 Bipolar Optional Modes 80104 521 06 2009 Diagrams BIPOLAR PRECISE CUT R 500 Ohm 60 50 dn Effect 1 8 5 E 2 o 30 u r 20 o a 10 0 0 20 40 60 Power HF max W Fig 10 2 BIPOLAR PRECISE CUT 60 50 em ffect8 a Effect 40 e ffect6 N e Effect 5 30 Effect 3 Effect3 20 e Fffect2 oF ffect1 10 eee Pmax 25W 0 100 1000 10000 Resistance Ohm Fig 10 3 113 166 10 Bipolar Optional Modes Properties Applications Difference from BIPOLAR SOFT 114 166 Suitable electrodes Technical data BIPOLAR PRECISE CUT 450 400 350 e ffect8 ffect7 300 eu ffact6 250 Effect5 H 200 Effect4 2 Effect 159 e Effect2 100 ffoct1 50 0 0 10 20 30 40 50 60 Power W Fig 10 4 BIPOLAR PRECISE COAG gt Very fine adjustment extremely precise power output in the 1 to 50 W range Coagulation processes w
119. rical values displayed are measurement values Pmax refers to the maximum output of the last activation This may lie above the power limitation level selected if PPS Power Peak System is permitted Pavg refers to the average power consumed over a unit of time to be specified Maximum HF voltage Vp display when activating the unit This maximum elec trical capacity is given in Vp in the user manual of the instrument or on the instru ment itself If the voltage is greater than the capacity of the instrument the instru ment can be damaged In such cases select a smaller effect Input of start delay for the AUTO START function 0 0 to 9 5 sec in 0 1 sec steps Input of start delay for the AUTO START function 0 1 to 10 sec in 0 1 sec steps This menu item is provided for Service 80104 521 06 2009 80104 521 06 2009 6 Description of receptacle hardware CHAPTER 6 Description of receptacle hardware Purchasing further receptacles You can individually select the receptacles of your electrosurgical unit when placing your order After purchase it is possible to add further receptacles or to replace ex isting receptacles with others A receptacle module consists of a front plate receptacle insert and two holding clips Installation in the electrosurgical unit is simple and can be carried out quickly by any technician authorized by ERBE Receptacles for different modes and instrument connectors In this chapter
120. rm Rated frequency Crest factor Rated load resistor Max HF peak voltage Number of effects Constancy of effects HF power limitation Max power output at rated load resis tor pulse modulated sinusoidal alternat ing voltage 350 kHz at Ry 500 ohms 10 3 5 at R 500 ohms 500 ohms 1 550 Vp 8 automatic control of HF peak voltage 10 watts to 200 watts in 1 watt steps 200 watts 20 77 1166 7 Monopolar Standard Modes 78 1166 Diagrams DRY CUT R 500 Ohm 250 200 e Effect8 mu E ffect7 5 e Fffecto amp 150 5 m ffect5 Efect4 ra 100 Effect3 3 Effect2 50 Effect 0 0 100 200 Power HF max W Fig 7 10 DRY CUT 250 e Effect 200 effect e ffecto 150 mu Fffect5 5 Effect4 3 amm e 100 Effect3 e Effect2 Bb ffect1 a Pmax 100W 0 10 100 1000 10000 Resistance Ohm Fig 7 11 80104 521 06 2009 7 Monopolar Standard Modes 80104 521 06 2009 Properties Areas of use Suitable electrodes Technical data DRY CUT 1800 1600 1400 Effect8 n ffoect7 a ere 1000 Effects 2 Effect3 600 e Effect2 400 Effect 200 0 0 50 150 200 250 Power W Fig 7 12 SOFT COAG mm Amm Carbonization of the tissue is prevented adhesion of the electrode to the tissue is greatly reduced Greater
121. rm Technical Service Program memory fault Restoring basic program setting If this recurs please inform Technical Service Program memory fault The stored program could not be called up If this recurs please inform Technical Service Activation type unavailable For further information consult user manual Please check time in system menu No other mode can be selected for this instrument Footswitch not assigned Footswitch activated but not assigned to a socket Two footswitches connected Two footswitches of the same type connected For further information consult user manual Invalid system component The connected component is not compatible with the VIO system Inform Technical Service Please confirm settings Cannot activate device until current settings have been confirmed Cannot activate mode Attempt made to activate a mode that is switched off or unavailable For further information consult user manual Instrument not connected Socket activated to which no instrument is connected Or attempt made to activate an instrument with old invalid software 16 Status Messages Error Messages 80104 521 06 2009 Error Messages B B0 B AC B B1 B B3 B B7 B BB B C0 B C6 X 81 86 NESSY symmetry When applying neutral electrode patient plate ensure that neutral electrode line of symmetry runs towards the operating field Contact detected Attempt made to assign the AUTO START function to the
122. rs on all cords to make sure they are secure Activation of the unit with no knowledge of active settings If the user does not understand the active settings of the unit he can cause the patient accidental tissue damage Check the active settings on the display of the unit after switching on the unit connecting up an instrument and chang ing the program 17 166 1 Safety Instructions 18 166 The user was not informed of a change in maximum ON time Risk of accidental tissue damage to the patient All users must be informed of any change in maximum ON time at an early stage That is before the user works with the modi fied maximum ON time for the first time The temperature at the return electrode site increases during long and continuous activations therefore ensure that the cool ing phases between activations are sufficient Tissue structures vessels with a cross section that is small or becoming smaller If monopolar HF current flows through parts of the body with a rel atively small cross section there is a risk of unintentional coagula tion for the patient If possible use the bipolar coagulation technique Activation signal not audible You do not hear the signal when the electrosurgical unit is activat ed Risk of burns to the patient and medical personnel Adjust the activation signal so that it is clearly audible 80104 521 06 2009 Undesirable contact between the activ
123. se 151 Safety Instructions seans se ka toe te et ete Ee td 151 Status Messages Error Messages eese 153 General Technical Data niin anak aaa anin 157 Information on electromagnetic compatibility EMC 159 Guidelines for avoiding recognizing and rectifying unwanted electromagnetic effects on other equipment or systems which are the result of operating the VIO system sees emen 159 Maintenance Customer Service Warranty Disposal 165 Maintenance lee alunni alati 165 CUSTOMET serViCe citrina ie anla 165 Table of Contents 8 166 80104 521 06 2009 80104 521 06 2009 1 Safety Instructions CHAPTER 1 Safety Instructions Intended use The VIO 300 D is an electrosurgical unit for cutting and coagulation Thanks to its performance features it offers universal applications Combination with other equipment You can combine this unit with matching ERBE equipment e g APC 2 EIP 2 You will then have a well conceived coordinated system Safety notations A DANGER indicates an imminently hazardous situation which if not avoided will result in death or serious injury indicates a potentially hazardous situation which if not avoided could result in death or serious injury indicates a potentially hazardous situation which if not avoided may result in minor or moderate injury used without the safety alert symbol indicates a potenti
124. sitioning the return electrode above the heart Risk of ventricular fibrillation and cardiac arrest for the patient Do not position the return electrode over the heart or in the re gion of the heart Incorrect application of the return electrode Risk of burns to the patient Apply the entire contact surface of the return electrode to a mus cular part of the body with good blood circulation Apply the return electrode as close as possible to the surgical site Insert the contact tab of the return electrode completely into the connecting clamp The contact tab must not touch the patient s skin For reusable cord with disposable pads only Align the symmetry line of the return electrode towards the op erating field The current should flow from the active electrode instrument to the symmetry line of the return electrode Check the return electrode regularly for good contact with the patient s skin Check the return electrode especially when the patient has been repositioned and after surgical steps where the device was acti vated frequently and for a long time 19 166 1 Safety Instructions 20 166 Fig 1 1 Short circuit in the connecting cord or in the clip of a dual sur face return electrode With the NESSY setting NE either way setup and a short circuit in the connecting cord or in the clip of a dual surface return elec trode the device can no longer monitor the contact with
125. structions 80104 521 06 2009 Failure of display elements If display elements fail you can no longer operate the device safely Risk of injury or death for patients and medical staff You must not use the unit Interference caused by the unit Interference with cardiac pacemakers internal defibrillators or other active implants Activation of the electrosurgical unit may affect the performance of active implants or damage them Risk of injury or death for patients In the case of patients having active implants consult the man ufacturer of the implant or the competent department of your hospital prior to performing surgery Do not position the return electrode near cardiac pacemakers internal defibrillators or other active implants Interference with electronic equipment due to the electrosurgi cal unit The activated electrosurgical unit can affect the performance of electronic equipment by causing interference The equipment may fail or not perform properly Position the electrosurgical unit the cords of the instruments and the cord of the return electrode as far away as possible from electronic equipment Position the cords as far away as possible from the cords of elec tronic equipment Low frequency currents stimulate nerves and muscles Neuro muscular Stimulation Low frequency currents arise either due to low frequency power sources or partial rectification of the HF current During
126. t2 ed 20 Effect1 0 0 20 40 60 Power W Fig 10 7 80104 521 06 2009 80104 521 06 2009 11 APC receptacle only available with the APC module CHAPTER 11 APC receptacle only available with the APC module APC receptacle Cutting and coagulation modes Standard e Forced APC Precise APC e Pulsed APC e Argon assisted AUTO CUT Mode e Argon assisted HIGH CUT Mode e Argon assisted DRY CUT Mode e Argon assisted DRY CUT Mode e Argon assisted SWIFT COAG Mode e Argon assisted SWIFT COAG Mode e Argon assisted FORCED COAG Mode e Argon assisted SOFT COAG Mode Optional e Argon assisted TWIN COAG Mode 117 166 11 APC receptacle only available with the APC module 118 166 80104 521 06 2009 80104 521 06 2009 12 APC Standard Modes Only Available with an APC Module CHAPTER 12 APC Standard Modes Only Available with an APC Module FORCED APC Properties Standard setting for the APC with ignition assistance for safe ignition of the plasma Areas of use Hemostasis of small diffuse areas of bleeding Devitalization and reduction of tis sue Setting The intensity of the thermal effect can be set with the power The higher the power the higher the intensity of the thermal effect Suitable instruments Rigid APC applicators flexible APC probes Technical data x 3 HF voltage waveform pulse modulated sinusoidal alternat ing voltage Rated frequency 350 k
127. tact with the patient indirectly through electrically con ductive objects or wet drapes for example Unintentional activation of the instrument during an endo scopic application If the instrument is activated and remains activated during an endo scopic application the patient can suffer burns when the instrument is removed All points that come into contact with the active part of the instru ment are at risk The cause of unintentional activation can be a fault in the footswitch or device or operator error for example You will recognize unintentional activation from the continuous ac tivation signal Risk of burns to the patient Turn off the power switch on the electrosurgical unit immedi ately Only then should the instrument be removed from the pa tient s body 80104 521 06 2009 1 Safety Instructions 80104 521 06 2009 Capacitive coupling between the cords of two instruments When one instrument is activated current can be transferred to the cord of another instrument capacitive coupling The patient can suffer burns if the non active but still live instru ment has direct or indirect contact with the patient Risk of burns to the patient Lay the cords of instruments in such a way that they are as far apart as possible Put instruments down in a safe place sterile dry non conduc tive and easy to see Instruments that have been put down must not come into contact with the pat
128. the NESSY setting set to NE dynamic or NE dual surface With this combination the optimal use of the safety monitoring functions are given see chapter 2 NESSY Safety Features If the unit is activated in a monopolar mode using a cable with a short the unit will give an audible warning signal and will display a B B error message on the screen How do I receive information about the safety status of the return electrode NEUTRAL Fig 5 20 The neutral electrode socket is equipped with indicator lights which represent a dual surface electrode 1 and a single surface electrode 2 respectively Call up the NESSY window using the Focus button Here you can check which setting is active in the unit s service programs 5 e Working with the Electrosurgical Unit a Tutorial 80104 521 06 2009 e Neutral electrode Dual surface Neutral electrode Dual surface Neutral electrode Either way Neutral electrode Single surface If the unit is set for a dual surface dynamic electrode and you connect a single sur face electrode the dual surface indicator light will illuminate red If the unit is set for a single surface electrode and you connect a dual surface electrode the single indicator light will illuminate red In both cases you can only activate monopolar mode if you connect the correct electrode No electrode connected If you switch on the unit without having connected an electrode the indicator
129. the receptacles are described from the aspect of their usage and com patibility with various instrument connectors Cutting and coagulation modes Specific cutting and coagulation modes are allocated to the receptacles Via the mo nopolar receptacle you can thus activate AUTO CUT and SOFT COAG for exam ple If you require SOFT COAG for one of your applications the monopolar recep tacle is used Instrument compatibility The VIO electrosurgical unit is sold all over the world The standard instrument con nectors vary from country to country To ensure your instruments can be connected to the electrosurgical unit the receptacles are available in various designs Monopolar receptacle Cutting and coagulation modes Standard e AUTO CUT HIGHCUT e DRY CUT e DRY CUT SOFT COAG e SWIFT COAG SWIFT COAG FORCED COAG SPRAY COAG Optional e PRECISE CUT ENDOCUTO e ENDO CUTI TWIN COAG PRECISE COAG 65 166 6 Description of receptacle hardware 66 166 Instrument compatibility Receptacle module MO 9 5 ERBE No 20140 620 Fig 6 1 The receptacle module is suitable for the following connectors monopolar recepta cle based on ERBE standard Contact ring which transmits activation signal dia 9 mm HF contact ring dia 5 mm Receptacle module MO 4 Fig 6 2 ERBE No 20140 621 The receptacle module is suitable for the following connectors monopolar connec tor dia 4 mm mainly
130. the unit The middle indicator 2 shows the contact resistance as a numerical value The diagram on the right 3 shows the contact resistance as a bar The upper and lower limits of the Green safety status are indicated by a red line at the top and bot tom The lower limit is 20 ohms The upper limit is not fixed at 120 ohms but de pends on the lowest contact resistance measured between skin and neutral electrode measured value The upper limit is reduced relative to the measured value to en sure that a critical detachment of the neutral electrode from the skin is detected in good time The NESSY window as a visual When you apply a dual surface electrode to the patient s skin first change to the aid to applying a dual surface NESSY window With the aid of its displays you can recognize how good the skin electrode contact is Ideally the contact resistance should be between 20 and 120 ohms The NESSY window when con To check a single surface electrode it is sufficient to observe the indicator lights necting a single surface Similarly in the NESSY window you will only receive the information Safety sta electrode tus Green or Red When a single surface electrode is connected the NESSY window does not give any visual assistance The contact between electrode and skin cannot be measured when a single surface electrode is used Automatic monitoring of equipment output error The unit is equipped with an automatic monitoring system
131. tions of the other units The ECB ensures communication between the units Connect an ECB cable to this socket and connect it to one of the other units 37 1166 4 Description of the Controls 38 166 Potential equalization Power fuses Power connection 4 Potential equalization terminal Connect a potential equalization line and connect this to the potential equalization system of the operating room If you are using the ERBE VIO CART connect the potential equalization line to the potential equalization pin of the VIO CART 5 Power fuses The unit is protected with power fuses If one of these power fuses has blown the unit may not be used on the patient again until it has been checked by a competent technician The values of the power fuses are specified on the unit s rating plate Only spare fuses with these values may be used 6 Power connection Connect the unit to a properly installed grounded outlet Only use the ERBE power cord or an equivalent power cord for this purpose The power cord must bear the na tional test symbol If the unit is installed on the ERBE VIO CART make the power connection with the power cord of the VIO CART 80104 521 06 2009 80104 521 06 2009 5 e Working with the Electrosurgical Unit a Tutorial CHAPTERS Working with the Electrosurgical Unit a Tutorial The tutorial and your electrosurgical system You have an individually config The electrosurgical unit is part
132. tor compatibility Receptacle module NE 6 Fig 6 10 ERBE No 20140 640 The receptacle module is suitable for the following connectors ERBE return elec trode connector 6 35 mm Receptacle module NE 2 pin Fig 6 11 ERBE No 20140 641 The receptacle module is suitable for the following connectors Return electrode connector with 2 pins Receptacle module NE 6 NE 2 pin Fig 6 12 ERBE No 20140 642 You may connect ONE of the following plugs ERBE return electrode plug with 6 35 mm return electrode plug with 2 pins The receptacle is equipped with a slide switch that allows you to connect the plug with 6 35 mm or the plug with 2 pins based on the position of the receptacle see illustration above 69 166 6 Description of receptacle hardware 70 166 80104 521 06 2009 7 Monopolar Standard Modes 80104 521 06 2009 CHAPTER 7 Monopolar Standard Modes AUTO CUT Properties Reproducible gentle cuts extra kind to tissue minimal to medium hemostasis PPS Power Peak System The AUTO CUT mode is equipped with PPS A special problem during incision may be posed by the initial incision phase in particular when the cutting electrode is pressed firmly against the tissue to be cut before activation of the HF generator so that the cutting electrode has a relatively extensive and thus low resistance contact with the tissue This is generally the case for example with TUR and endoscopic po
133. trode Either way setup not illustrated The diagram on the right 3 shows the contact resistance as a bar The upper limit of the Green safety status is indicated by a red line The upper limit is 120 ohms 80104 521 06 2009 5 e Working with the Electrosurgical Unit a Tutorial 80104 521 06 2009 Dual surface neutral electrode The Neutral electrode Dynamic setup offers extra safety for patients with low connected Neutral electrode skin resistance for example patients with little subcutaneous fatty tissue children Dynamic setup and infants Even with these patients critical detachment of the neutral electrode from the skin is detected in good time Checking function of the NESSY window when a dual surface NESSY dynamic electrode is connected with Neutral electrode Dynamic 4 setup gt lt gt lt p Return lt Fig 5 23 If you press the Focus button on the neutral electrode socket you change to the NESSY window You will see a traffic light symbol 1 According to the contact resistance between skin and electrode this symbol shows the following Safety status Green The unit can be activated without any danger for the patient e Safety status Red You cannot activate the unit The middle indicator 2 shows the contact resistance as a numerical value The diagram on the right 3 shows the contact resistance as a bar The upper and lower limits of the Green safety status are in
134. ttings Overwrite changed program Test Save gt lt Gum ec Io aem Fig 5 25 1 Call up the program Test Change any setting 2 Press the Enter button You will then move to the window Save 3 Press the selection button next to the menu item Prog no 2 Test overwrite Save as Save b Password No Hold down for 3 secs Fig 5 26 4 You will then move to the window Save as Depress the Enter button for 3 sec to overwrite the program 57 1166 5 e Working with the Electrosurgical Unit a Tutorial What is the ReMode function 58 166 used for Creating all settings for a program from scratch You can create a program from an empty program template Call up the menu item Guide Select the menu item Select Program From the program selection list select New program You will then move back to the window Guide Look at the sche matic display of the receptacles In the new program all CUT and COAG Modes are switched off Select a receptacle Select the mode effect power limitation and acti vation Deleting a program Call up the menu item Guide Select the program you want to delete Call up the menu item Additional Functions Select Delete Depress the Enter button for 3 sec to delete the program Creating programs for ReMode function With the ReMode switch of the footswitch 1 or certain handles 2 you can switch between two programs a and b without having to operate the unit
135. used in endoscopy for polypectomy loops etc Receptacle module MO 3 pin Bovie e e Fig 6 3 80104 521 06 2009 ERBE No 20140 622 You can connect ONE of the following connectors as required a monopolar 3 pin connector a Bovie connector a monopolar connector dia 4 mm to the input marked blue Receptacle module MO 3 pin 9 5 Fig 6 4 ERBE No 20140 623 You can connect ONE of the following connectors as required a monopolar 3 pin connector a monopolar receptacle based on ERBE standard a monopolar connector dia 4 mm to the input marked blue 6 Description of receptacle hardware 80104 521 06 2009 Cutting and coagulation modes Instrument compatibility Bipolar receptacle Standard BIPOLARCUT e BIPOLAR SOFT COAG e BIPOLAR FORCED COAG Optional e BIPOLAR PRECISE CUT BIPOLAR PRECISE COAG Receptacle module BI 8 4 ERBE No 20140 610 Fig 6 5 The receptacle module is suitable for the following connectors Bipolar connector based on ERBE standard Rear contact ring dia 8 mm front contact ring dia 4 mm Receptacle module BI 2 pin 22 Fig 6 6 ERBE No 20140 612 The receptacle module is suitable for the following connectors international bipolar connector with 2 pins pin spacing 22 mm Receptacle module BI 2 pin 28 Fig 6 7 ERBE No 20140 611 The receptacle module is suitable for the following connectors international bipolar connector with 2 pins
136. ustomer Service Warranty Disposal CHAPTER 19 Maintenance Customer Service Warranty Disposal Maintenance Modifications and repairs Modifications and repairs must not impair the safety of the equipment or equipment cart and accessories for the patient user and the environment This condition is met when changes to the structural and functional characteristics are not detrimental to safety Authorized persons Modifications and repairs may only be undertaken by ERBE or by persons expressly authorized by ERBE ERBE accepts no liability if modifications and repairs to the unit or accessories are made by unauthorized persons This will also invalidate the warranty Safety checks The safety checks determine whether the safety and operational readiness of the unit or the equipment cart and accessories conform to a defined technical required status Safety checks must be performed at least once a year What safety checks must be For this device the following safety checks have been stipulated performed e Checking of labels and User Manual e Visual inspection of unit and accessories for damage Testing the grounded conductor in accordance with IEC 60601 1 Section 18 Testing the leakage current in accordance with IEC 60601 1 Section 19 Functional testing of all the unit s operating and control elements Testing the monitoring equipment Measurement of DC resistance Testing footswitch and fingerswitch activation Test
137. uto Start lights up at the bipolar receptacle The selection of AUTO START is only possible for bipolar coagulation If you have assigned Auto Start to the bipolar receptacle CUT can no longer be ac tivated with the footswitch By selecting the COAG mode you can select an AUTO STOP function for example BIPOLAR SOFT with AUTO STOP AUTO STOP ends activation automatically before the tissue adheres to the instrument 80104 521 06 2009 5 e Working with the Electrosurgical Unit a Tutorial 80104 521 06 2009 Instrument at monopolar and bipolar receptacle What settings are displayed in the window Cut Coag Settings what settings do want to activate Check settings if in doubt What is NESSY The NESSY settings The Focus View and activation concept of the electrosurgical unit What points must observe O Basic program gt Monopolar 4 ng receptacle Mode x Mode gt HIGH CUT geloot 4 Effect max watts gt 140 Fig 5 19 Please imagine the following situation The yellow pedal CUT 1 is allocated to the monopolar receptacle The blue pedal COAG 2 is allocated to the bipolar recepta cle An instrument that you are using alternately is connected to both receptacles Cutting with the monopolar receptacle coagulation with the bipolar receptacle After you have activated cutting for the monopolar receptacle the window Cut Coag Settings displays the settings for the monopolar rec
138. val Cutting duration Depending on the size type and location of lesions it may be advantageous to vary cutting duration You can set cutting duration to one of 4 levels Cutting duration has a major influ ence on cutting width Cutting interval The cutting interval is the amount of time between the start of a cutting cycle and the start of the next cutting cycle The cutting interval is thus comprised of one cut ting cycle and one coagulation cycle You can set the cutting interval to one of 10 levels The higher the level the longer the cutting interval and coagulation cycle A short cutting interval makes it easier to remove the lesion quickly A long cutting interval makes it easier to remove the le sion slowly under control Technical data HF voltage waveform unmodulated sinusoidal alternating voltage Rated frequency 350 KHz at Ry 500 ohms 10 Crest factor 1 4 at R 500 ohms Max HF peak voltage 550 Vp Number of effects 4 Constancy of effects automatic control of HF peak voltage Max power output at rated load resis 155 watts 20 tor Diagrams ENDO CUT I HL LIE ULI I L LL INC Outting stage max Power Outting stage min Power M ELE LL UU o TM I m LL 100 1000 10000 Resistance Ohm Fig 9 5 105 166 9 Monopolar Optional Modes Properties Applications Difference from SOFT COAG 106 166 Suitable electrodes Technical data Diagrams PRECISE COA
139. ve humidity 10 95 Ambient conditions for operation of unit Temperature 10 C to 40 C Relative humidity 15 80 noncondensing Acclimatizing If the unit has been stored or transported at temperatures below 10 C or above 40 C the unit will require approx 3 hours to acclimatize at room temperature 157 166 17 General Technical Data Standards Classification according to EC Directive 93 42 EEC Protection class as per EN 60 601 1 Type as per EN 60 601 1 158 166 Ib CF 80104 521 06 2009 18 Information on electromagnetic compatibility EMC 80104 521 06 2009 CHAPTER 18 Information on electromagnetic compatibility EMC Where EMC is concerned medical electrical equipment is subject to special safety measures and must be installed and commissioned according to the EMC instruc tions stated herein Guidelines for avoiding recognizing and rectifying unwanted elec tromagnetic effects on other equipment or systems which are the result of operating the VIO system When VIO electrosurgical units are activated disturbance of other equipment or systems in the immediate vicinity can occur This can be recognized as for example image artifacts in imaging devices or unusual fluctuations in measured value dis plays Such disturbances from an activated electrosurgical unit can be reduced by placing it further away and or carrying out suitable shielding measures on the equi
140. vel NESSY offers with various com binations 51 166 5 e Working with the Electrosurgical Unit a Tutorial 1 Dual surface NE setting NE Dynamic 2 Dual surface NE setting NE Dual surface 3 Dual surface NE setting NE Either way 4 Single surface NE setting NE Either way 4 Single surface NE setting NE Single surface Observe the indicator lights 52 1166 Unit NE con Skin NE NE applica Higher safety for patients nection contact tion direction with low skin resistance e e 9 e e e e e Partial Partial observe warn observe warn ing ing e e Short circuit in the connecting cord or in the clip of a dual sur face return electrode With the NESSY setting NE either way setup and a short circuit in the connecting cord or in the clip of a dual surface return elec trode the device can no longer monitor the contact with the pa tient s skin or the application direction of the contact surface You will not receive a warning if the electrode becomes detached from the skin You will not receive a warning if the application direction of the return electrode is incorrect Risk of burns to the patient Safety Features for NESSY To rule out the possibility of a short circuit in the connecting cord and the clip before use see Chapter 2 of this Manual 80104 521 06 2009 Note ERBE recommends the use of split return electrodes in combination with
141. w coagulation depth The coagulation depth is set with effect levels A low effect level means very su perficial and a high effect level means greatest possible penetration depth PRECISE APC is a current waveform which is modulated by the spark signal Finer graduation of the effect levels is achieved using the Modulation value This means the larger the Modulation value the closer the thermal effect is to the next highest effect level Rigid APC applicators flexible APC probes pulse modulated sinusoidal alternat ing voltage HF voltage waveform Rated frequency 350 kHz at Rj 500 ohms Crest factor 7 4 at R 500 ohms Rated load resistor 1 000 ohms Max HF peak voltage 4 300 Vp Number of effects 8 121 166 12 APC Standard Modes Only Available with an APC Module Diagrams Properties Area of use Setting Suitable instruments Technical data 122 166 Constancy of effects automatic control of arc intensity Max power output at rated load resis 160 watts 20 tor PRECISE APC 180 160 140 120 100 6 Effect 1 8 3 80 a 60 40 20 0 100 1000 10000 Resistance Ohm Fig 12 4 PULSED APC mmm umma Defined output of individual APC impulses with well controllable change of effect at the tissue surface Hemostasis of diffuse areas of bleeding Devitalization and reduction of tissue with emphasis on controlled power
142. word Password gt lt EE ETA 4 b Cancel 4 2 The password is up to four characters long As an example we shall call the password Test Select the letter T using the Up Down buttons Press the Selection button arrow to move the cursor on to the next character By pressing the selection button next to the menu item Char set you can choose between upper case lower case and numbers 3 Press the Enter button to confirm the password This takes you to the window Save as 80104 521 06 2009 5 e Working with the Electrosurgical Unit a Tutorial 80104 521 06 2009 4 Press the Selection button next to the menu item Number The field Number is marked gray with a cursor Select a number with the Up Down buttons 1 The number refers to the free memory cells of the unit 5 Press the Selection button next to the menu item Name The field Name is marked gray with a cursor We want to call the program Test Select the letter T with the Up Down buttons Press the selection button next to the menu item Name again to move the cursor forward one letter By pressing the selection button next to the menu item Char set you can choose between upper case or lower case letters and numbers 6 Depress the Enter button for 3 sec to save the program Note You can change the settings of any program and then save it under a new name Overwriting a program You can change the settings of a program and overwrite it with the new se
143. ww Bo Other gt functions 4 Fig 5 3 If you want to accept the active Existing Program press the selection button next to the menu item Adopt program You will then move to the window Cut Coag Set tings You will then see the settings of the receptacle last activated The Focus but ton next to this receptacle is lit up Alternatively you can press the selection button next to a receptacle display e g the selection button next to the monopolar receptacle With this action you will like wise accept the program You will then move to the window Cut Coag Settings You will then see the settings for the receptacle selected The Focus button next to this receptacle is lit up Press the selection button next to the menu item Guide progs You will then move to the window Guide Select Program Guide 1 program xy gt Return Bipolar receptacle 4 BIP CUT EE 4 60W EE 60w Select oe receptacle E program Don BA ES 4 4 180W Basi 10 300 D me C a ED gt 5 4 Fig 5 4 If you want to use another program press the selection button next to the menu item Select program 80104 521 06 2009 5 e Working with the Electrosurgical Unit a Tutorial 80104 521 06 2009 2 Select Program Select Program gt o Q Basic program O 7T Pme 4 gt New program O 4 2 gt O d Fig 5 5 You will then move to the window Select Program You will then see a selection list of progra
144. x HF peak voltage 1450 Vp Number of effects 8 Constancy of effects automatic control of HF peak voltage 128 166 80104 521 06 2009 12 APC Standard Modes Only Available with an APC Module 80104 521 06 2009 HF power limitation 10 watts to 200 watts in 1 watt steps Max power output at rated load resis 200 watts 20 tor Diagrams DRY CUT R 500 Ohm 250 200 ffect8 ffect7 ffect6 fect5 Effect4 Effect3 e Effect2 e F ffect1 a c O o o Power HF output W a O 0 100 200 Power HF max W Fig 12 14 DRY CUT em ffect8 ffect7 ffect6 ome F ffect5 Effect4 Effect3 e Effect2 e ffect1 ezio P max 100W Power W 100 1000 10000 Resistance Ohm Fig 12 15 129 166 12 APC Standard Modes Only Available with an APC Module Properties Difference compared with Dry 130 166 Cut Areas of use Suitable electrodes Technical data DRY CUT 1600 1400 e Effect8 1200 e Effoct7 1000 e Effecto PEffect E 309 Effect4 gt 600 Effect3 cu 400 Effect2 m Effect 200 0 0 50 100 150 200 250 Power W Fig 12 16 Argon assisted DRY CUT Mode E a om Intense haemostasis with somewhat slower cutting speed Changed ratio of crest factor to RF peak voltage E g
145. y non conduc tive and easy to see Instruments that have been put down must not come into contact with the patient medical personnel or combustible materials Flammable detergents and disinfectants flammable solvents in adhesives used on the patient and on the device equip ment cart Risk of fire and explosion to the patient and medical personnel Risk of damage to property Use products that are not flammable If the use of flammable products is unavoidable proceed as fol lows Allow the products to evaporate completely before switching on the device Check whether flammable liquids have accumulated under the patient in body recesses such as the navel or in body cavities such as the vagina Remove any liquids before performing elec trosurgery Ignition of anesthetics skin cleansers and disinfectants in potentially explosive atmospheres If you place the device in a potentially explosive atmosphere anes thetics skin cleansers and disinfectants can ignite Risk of fire and explosion to the patient and medical personnel Risk of damage to property Do not place the device in potentially explosive atmospheres 80104 521 06 2009 1 Safety Instructions 80104 521 06 2009 Burns Damaged device damaged accessories modified device and modified accessories Risk of burns and injury to the patient and medical personnel Risk of damage to property Check the device and accessories
146. y suitable for preparation with high hemo stasis owing to its limited tissue cutting property Two monopolar instruments can be activated at the same time WARNING In the TWIN COAG mode the output power of any of the active elec trodes can change Setting When carrying out the first selection of TWIN COAG you are requested to select a second additional monopolar socket on the VIO or APC 2 by pressing the required Focus button Activation The TWIN COAG function can be called up on the two selected sockets simulta neously If one of the two sockets requires a CUT function they must be activated alternately Areas of use Especially in disciplines where simultaneous coagulation and preparation is re quired e g in heart and breast surgery Suitable electrodes APC applicators with adjustable electrode Monopolar electrodes for inserting on the APC handpiece Technical data HF voltage waveform pulse modulated sinusoidal alternat ing voltage Rated frequency 350 KHz at Rj 500 ohms 10 Crest factor 5 0 at Rj 500 ohms Rated load resistor 500 ohms Max HF peak voltage 2000 Vp Number of effects 8 Constancy of effects automatic control of HF peak voltage HF power limitation 5 watts to 200 watts in 1 watt steps Max power output at rated load resis 200 watts 20 tor 141 166 13 e APC Optional Modes Only Available with an APC Module 142 166 Diagrams

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