Ellman International Surgitron Dual RF Service Manual [PDF]

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®



CONTENTS I.



Introduction 1.1 1.2 1.3 1.4



II.



2.2 2.3



Page 4



Special feature - Mode and Power Output Level Memory Dual Footswitch and 3-Button Fingerswitch Handpiece Rear Panel Front Panel



Technical Specifications 3.1 3.2 3.3 3.4 3.5



IV.



Symbol Definitions Installation Cleaning and Disinfecting Duty Cycle



Description of Control Elements 2.1



III.



Page 2



Page 11



Output Characteristics Safety Features Input Characteristics Size and Weight Error Codes Table



Test Procedure 4.1 4.2 4.3



Page 13



Supplier’s Information Inspection Check List Power Output Figures (Diagrams) 4.3.1 Power Output vs. Digital Setting 4.3.2 Cut Mode Power Output vs. Resistive Load 4.3.3 Coag Mode Power Output vs. Resistive Load 4.3.4 Hemo Mode Power Output vs. Resistive Load 4.3.5 Fulgurate Mode Power Output vs. Resistive Load 4.3.6 Bipolar Mode Power Output vs. Resistive Load



V.



Structure of Surgitron® Unit



Page 26



VI.



Parts List



Page 27



3



INTRODUCTION



This Service Manual consists of the general technical information, specification, test procedures, troubleshooting guide, hardware structure, and circuit diagram of the ellman Dual High Radio Frequency Surgical generator (ellman Surgitron® 4.0 Dual RF/120 IEC). Instruction for use and cautions and warnings concerning ellman Surgitron® 4.0 Dual RF/120 IEC are given in the Instruction Manual supplied with the ellman Surgitron® 4.0 Dual RF/120 IEC. The ellman Surgitron® 4.0 Dual RF/120 IEC is a enhanced capability Radiosurgical Generator. It is a compact source of high power RF energy to be employed for a variety of Radiosurgery™ procedures. This action is achieved by front panel selection of waveforms and power levels. All selections are effected through push buttons and lamps which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. This display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and/or hand switches. An internal memory provides a special feature for the storage of all the front settings, mode and power output level. Both Monopolar and Bipolar electrodes are provided. It is designed to comply with international safety standards. The ellman Surgitron® 4.0 Dual RF/120 IEC High-Frequency Radiosurgical Generator must be inspected for technical safety at least once a year. These technical safety inspections consist of: * Inspection of electrical safety in compliance with IEC 60601-1 and 60601-2-2 * Inspection for damage to the unit and its accessories * Inspection of proper function of the unit * Inspection of high-frequency output power in the variety of modes These technical safety inspections should be entrusted only to ellman trained personnel. The manufacturer assumes no responsibility for improper changes or repairs carried out on the unit or its accessories by unauthorized persons, and the warranty of the unit expires immediately.



ellman reserves the right to make any changes in construction of the ellman Surgitron® 4.0 Dual RF/120 IEC without incurring any obligation at any time.



1.1.



SYMBOL DEFINITIONS The following symbols are used on the equipment 1.1.1



Classification = Class 1



1.1.6



Neutral Electrode Referenced to Ground



1.1.2



Supply Input Power = 240V, 220V, 120V, 100V ~ 50/60 Hz Option = 240V, 230V, 120V, 100V ~ 50/60 Hz



1.1.7



Finger Switch Control



Type BF defibrillator protection



1.1.8



Foot Switch Control



Refer to Manual



1.1.9



Neutral plate



Protective Earth Connection



1.1.10



Non-Ionization radiation



1.1.3 1.1.4 1.1.5



!



4



1.2



INSTALLATION The ellman Surgitron® 4.0 Dual RF/120 IEC is a portable unit and can be installed in a variety of ways. It may be placed on any convenient and sturdy table or on the mounting cart (ellman IEC cart P/N#IEC-C100). The power amplifier within the unit generates heat. The metal enclosure of the unit is utilized to transfer and radiate the heat to the surrounding air, therefore, the ellman Surgitron® 4.0 Dual RF/120 IEC unit should be placed in the open space for the free circulation of air. It is normal for the cover of the enclosure to feel warm after an extended continuous operation. Input characteristics of the Surgitron® 4.0 Dual RF/120 IEC unit are listed as following: 1.2.1 1.2.2 1.2.3 1.2.4 1.2.5



Nominal Nominal Nominal Nominal Nominal



line line line line line



voltage voltage voltage voltage voltage



240 Volt/120 Volt +/-10% 60 Hz/ 50 Hz 330 VA 1.3 A/ 2.90 A T2A (250V)/ T4A(250V)



An approved hospital grade three-prong plug power cord, or standard European power cord, is supplied with the unit. The power cord meets all requirements for safe grounding. 1.3



CLEANING AND DISINFECTION Cleaning and disinfection of the unit should only be done with nonflammable and nonexplosive agents. Make sure that no moisture or detergents enter the unit. If cleaning or disinfecting of the unit with flammable or explosive agents is unavoidable, these must be completely evaporated from the unit before it is switched on. The dual footswitch pedal is a waterproof unit, it can be cleaned with regular detergent. ATTENTION:



1.4



Alcohol must never be used to clean and disinfect the front panel. We recommend that the panel be disinfected by spraying or wiping. However, it is essential to follow the manufacturer’s directions regarding cleaning, disinfection and sterilization of the accessories.



DUTY CYCLE The operational duty cycle is suggested to be 10 seconds ON and 30 seconds OFF. The yellow indicator will be ON when CUT MODE is activated. The blue indicator will be ON when HEMO MODE is activated. The unit will sound a continuous tone when ON. After 55 seconds, the tone will change to alert the user the RF power will shut off automatically in 5 seconds to protect the unit from over heating.



1.5



THE PERMISSIBLE OPERATIONAL ENVIRONMENT CONDITIONS: o



o



o



o



ambient temperature range relative humidity range



+10 C ~ +40 C (50˚ F ~ 104˚ F) 30 ~ 75%



For transport and storage: ambient temperature range relative humidity range atmospheric pressure range



- 10 C ~ +50 C (14˚ F ~ 122˚ F) 10 ~ 95% 500 hPa ~ 1060 hPa



This unit has been checked for proper and safe operation prior to shipment. However, all equipment should be rechecked for proper and safe operation prior to initial operation, and before each subsequent use.



5



I. DESCRIPTION OF CONTROL ELEMENTS 2.1



SPECIAL FEATURE ellman Surgitron® 4.0 Dual RF/120 IEC has some unique special accessories which includes retractable mode and power output level settings, waterproof dual footswitch for CUT and COAG modes, and a Three-Button Fingerswitch Handpiece for CUT, CUT/COAG, and HEMO modes. The following are the descriptions: 2.1.1



MODE AND POWER OUTPUT LEVEL MEMORY 2.1.1.1 Mode and power output levels are stored in a non-volatile memory and recalled at the unit turn-on. 2.1.1.2 The memory is set to default values when shipped. To set default value, press and hold both the Cutting Mode and Coagulation Mode Select buttons simultaneously and turn on the unit. When “CLR” is displayed release the buttons.



2.1.2



DUAL FOOTSWITCH PEDAL AND 3-BUTTON FINGERSWITCH CONTROLS 2.1.2.1



Dual Footswitch Pedal:



CUT



COAG



The unit is equipped with a heavy duty waterproof dual footswitch pedal for CUT/COAG modes. The footswitch mode selector and light indicators described in the section 2.2.7, 2.2.8 and 2.2.9 will respond accordingly to the activated mode, i.e., the yellow light indicator will be "ON" when the Cut footswitch pedal is depressed. The blue light indicator will be "ON" when the COAG footswitch pedal is depressed. The light indicators are normally OFF in this footswitch controlled mode since the mode selection CUT or COAG is activated by the footswitch. i.e. the Footswitch mode switch will not be in effect. All modes, CUT, CUT/COAG, HEMO, FULGURATE, and BIPOLAR shall be selected by depressing the selector buttons on the front panel as well as adjusting the output power settings. The power output is activated by the footswitch pedal. The Footpedal will activate the mode that is lit up on the front panel.



2.1.2.2 3-Button Fingerswitch Handpiece Control: This patented, unique fingerswitch handpiece is implemented to control CUT, CUT / COAG, and HEMO. To activate this special function handpiece, depress the middle button on the fingerswitch handpiece and hold down for three seconds. As the button is held down the following sequence should be observed: a. "HOLD" should be displayed on the power display of the CUT mode. b. The power display of COAG mode starts to count down from "03","02","01" and then "0" c. Release this middle button on the 3-Button Fingerswitch Handpiece and the functions are successfully activated. Then all power displays return to previous power settings. d. Yellow light CUT and CUT / COAG indicators will alternate "ON" and "OFF" as well as blue light HEMO and BIPOLAR indicators. They are in standby, ready for action in CUT,CUT/ COAG, or HEMO mode by the fingerswitch handpiece control. e. Once the yellow and the blue lights are flashing set all appropriate power settings. The first yellow button activates the CUT mode. The middle yellow button activates the CUT/COAG mode. The blue button activates the HEMO mode. f. ONLY THE FOOTPEDAL CONTROL CAN ACTIVATE THE BIPOLAR FUNCTION The FULGURATE mode is not accessible.



6



To adjust the power output level if it is desired, the procedure is: a. Depress any push button in the front panel to temporarily stop and exit the flashing, no power levels or modes can be changed while the LED indicators are flashing. b. Press “SELECT” button to select the desired mode, then adjust the power output by depressing the up or down button to the desired power level for either CUT, CUT/COAG, BIPOLAR or HEMO mode. The user may continue to change modes and power levels. c. The unit will re-enter the flashing, 3-Button Fingerswitch mode, if no push buttons are depressed in three seconds. Repeat step (b) if further readjustment of power is desired. d. The fingerswitch and footswitch are disabled and no power can be output during the output power adjustment. Regression: The 3-button fingerswitch handpiece may be used as a conventional two-button fingerswitch handpiece if the BLEND mode is not activated by depressing it for more than three seconds. Or, the Surgitron® 4.0 Dual RF/120 IEC may be operated as an IEC unit to adopt an IEC 2-button Fingerswitch Handpiece, if a 3-Button Fingerswitch Handpiece is not available.



2.2



THE REAR PANEL CONTROL ELEMENTS see Figure 2.2 Rear Panel



2.2.1



POWER PLUG: The Surgitron® Unit is shipped with an approved hospital grade power connector. To ensure patient safety, the Surgitron® unit must be properly grounded.



2.2.2



POWER SOCKET: The Surgitron® unit must be connected to correctly installed sockets with a grounded earth conductor using the power cord supplied by the manufacturer.



2.2.3



LINE FUSES: The unit is protected with two line fuses. If fuse blows, the unit should be checked for possible faults before the fuse is replaced and the unit is operated again. Always replace with a fuse of the same rating.



2.2.4



AUDIO VOLUME CONTROL: The volume of the acoustic signal should be set to a volume that can easily be heard by the user.



2.2.5



FOOTSWITCH RECEPTACLE: This 9-pin receptacle accepts a Hypersonics Footswitch connector.



2.2.6



FOOTSWITCH: The unit is shipped with a waterproof Dual Footswitch



7



CUT



COAG



Figure 2.2 Rear Panel



8



Figure 2.3 Front Panel Control Elements



9



10



22



11



CUTTING CUTTING MODE MODE



7



SELECT SELECT



8



12 13 14



ENERGIZED



ellman llman



POWER



CUT CUT CUT/C OAG CUT/COAG



FOOTSWITCH FOOTSWITCH



INDICATOR MODE



23



SELECT SELECT



POWER



HEMO HEMO



2



FAULT FAULT



FULGURATE FULGURATE BIPOLAR BIPOLAR



15



20



4.0 Dual RF



ENERGIZED



COAGULATION COAGULATION MODE MODE



21



NEUTRAL NEUTRAL



4



120 IEC IEC 120



16 FINGERSWITCH / HANDPIECE



17



BIPOLAR HANDPIECE



NEUTRAL



ON/OFF



!



19



18



6



FINGERSWITCH HANDPIECE



3



5



BIPOLAR HANDPIECE



1



NEUTRAL



2.3 FRONT PANEL CONTROL ELEMENTS see Figure 2.3 for Description of the Front Panel Control Elements



2.3.1



POWER SWITCH:



1 = ON



1 0



0 = OFF



When the power switch is turned on, the unit always automatically performs the following function: • • •



The audio signal is activated after turning on the power switch. All start up sequence of tones on the front panel are activated automatically during the functional test. All front panel LEDS are activated. The patient return neutral plate is tested automatically. If the manufacturer provided neutral plate is not in place and not properly connected to the patient, the neutral optical signal will turn red and the audio alarm will sound until the patient return neutral plate is properly applied. The test is bypassed when the bipolar function is selected.



9



*



All power digital indicators shall be at initial state — “zero” shall be shown on both digital power indicators. If any error code is shown, the error must be cleared prior to using the equipment. For error codes information, see 3.6 - Error Codes Table



2.3.2



FAULT LED INDICATOR : It will be red if any error is detected, otherwise, it should be green.



2.3.3



NEUTRAL PLATE RECEPTACLE: The neutral plate must be applied to the patient and connected to the equipment for monopolar techniques. This unit is equipped with a neutral plate safety monitor which monitors the electrical connection between a split-neutral plates and the unit, as well as between the split-neutral plates and the patient.



2.3.4



NEUTRAL LED INDICATOR: The indicator lights up Red and triggers an audible alarm if the neutral plate is not properly applied. The LED indicator will turn to Green when the neutral plate is correctly applied. This function is automatically bypassed if Bipolar mode is selected.



2.3.5



BIPOLAR CORD RECEPTACLE: Bipolar function can be activated by footswitch controller only.



2.3.6



FINGERSWITCH/HANDPIECE RECEPTACLE: Fingerswitch function may be applied on “CUT/COAG” (blend) and “HEMO” modes. The regular Handpiece may be used for both Cutting Mode and Coagulation Mode with the footswitch only.



2.3.7



YELLOW LIGHT INDICATOR: The light indicator will be “ON” only when the “CUT” control footswitch is depressed in Surgitron® 4.0 Dual RF/120 IEC model.



2.3.8



BLUE LIGHT INDICATOR: The light indicator will be “ON” only when the “COAG” control footswitch is depressed in Surgitron® 4.0 Dual RF/120 IEC model.



2.3.9



CUTTING MODE FUNCTION SELECTOR: (SELECT) It is for selecting CUT or CUT/COAG functions. See section 2.1.2. for 3 Button-Fingerswitch Handpiece application.



2.3.10



YELLOW LIGHT (CUT) INDICATOR: The indicator illuminates when CUT function has been selected. See section 2.1.2. for 3 Button-Fingerswitch handpiece application.



2.3.11 YELLOW LIGHT (CUT/COAG) INDICATOR: The indicator illuminates when CUT/COAG function has been selected. See section 2.1.2. for 3 Button-Fingerswitch Handpiece application. 2.3.12 OUTPUT POWER INTENSITY INDICATOR: When the power switch is turned on, the settings that were last used will appear on the display. For true output power, see figure output power Intensity vs. Power Setting. The number displayed indicates the relative power, which will be delivered to the patient when the mode is activated. See section 2.1.2.2 for 3 Button-Fingerswitch Handpiece application.



10



2.3.13 POWER-UP PUSH BUTTON FOR CUTTING MODE: A single depression of the button switch increases the power setting by one. Continuous depression gradually increases the power to maximum - 100. See section 2.1.2. for 3-Button Fingerswitch Handpiece application. 2.3.14 POWER-DOWN PUSH BUTTON FOR CUTTING MODE: A single depression lowers the power setting by one. Continuous depression gradually decreases the power to minimum - “0”. See section 2.1.2. for 3-Button Fingerswitch Handpiece application. 2.3.15 COAGULATION MODE FUNCTION SELECTOR: (SELECT) It is for selecting Hemo, Fulgurate, or Bipolar function. 2.3.16 BLUE LIGHT INDICATOR: (HEMO) The indicator illuminates when Hemo function has been selected. 2.3.17 BLUE LIGHT INDICATOR: (FULGURATE) The indicator illuminates when Fulgurate function has been selected. 2.3.18 BLUE LIGHT INDICATOR: (BIPOLAR) The indicator illuminates when Bipolar function has been selected. 2.3.19 OUTPUT POWER INTENSITY INDICATOR FOR COAGULATION MODE: The initial state is zero when the power switch is turned on. See section 2.1.1 for the special features of the power storage. The output power will remain at the selected level unless it is changed. The number displayed indicates the relative power, which will be delivered to the patient when the mode is activated. For true output power, see Figure Output Power Intensity vs. Power Setting. 2.3.20 POWER-UP PUSH BUTTON SWITCH FOR COAGULATION MODE:



2.3.21 POWER-DOWN PUSH BUTTON FOR COAGULATION MODE:



2.3.22 YELLOW LIGHT INDICATOR: The yellow indicator will be ON when CUTTING MODE circuit is energized. 2.3.23 BLUE LIGHT INDICATOR: The blue indicator will be ON when COAGULATION MODE circuit is energized. . NOTE: To guarantee against cross-contamination, ellman international highly recommends the use of disposable electrodes and accessories.



11



III. TECHNICAL SPECIFICATIONS 3.1



OUTPUT CHARACTERISTICS



Mode/ Character Resistance



Output Waveform



M a x i m u m Power Output Power Output Output Power vs. Setting



Activation vs. Load



Cut



4.0 MHz CW sinusoid



120W



See Figure 4.1



See Figure 4.2



via foot pedal or fingerswitch



Cut/Coag



4.0 MHz with rectified full-wave envelope



80W



See Figure 4.1



See Figure 4.3



via foot pedal or fingerswitch



Hemo



4.0 MHz with square wave rectified envelope



60W



See Figure 4.1



See Figure 4.4



via foot pedal or fingerswitch



Fulgurate



4.0 MHz with modulated



40W



See Figure 4.1



See Figure 4.5



via foot pedal and handpiece



Bipolar



1.7 MHz with



120W



See Figure 4.1



See Figure 4.6



via foot pedal



NOTE: The open-circuit Output peak-to-peak Voltage for all modes is approximately 1,000 Volts.



3.2



SAFETY FEATURES All waveforms are interrupted at a 37 Hz. rate to allow sampling with the power off. 3.2.1



Standard Compliance



IEC60601-1 IEC60601-2-2



3.2.2



Neutral Plate Electrode



earthed at HF



3.2.3



Neutral Electrode monitor resistance between the 2 contact area of a split neutral electrode



MAX 1000 ohms



3.2.4



Alarm when resistance between the contact areas of a split neutral electrode is 1000 ohms or greater



Red signal indicator and audio alarm



3.2.5



Continuous temperature monitor during operations



If temperature rises above 85° C the unit will declare an error message - error code 12



3.2.6



Continuous power test/monitor output power



Error codes 13 if power test failed



3.2.7



Error indication after self check



Refer to listing of error codes



3.2.8



Defined duty cycle protection



10 sec. on active time/30 sec. off



12



3.3



3.4



3.5



3.6



CLASSIFICATION: 3.3.1



According to the type of protection against electrical shock: the equipment is energized from an external electrical power source and is Class I equipment.



3.3.2



According to the degree of protection against electric shock: Type BF equipment.



3.3.3



According to the degree of protection against harmful ingress of water: ordinary equipment.



INPUT CHARACTERISTIC 3.4.1



Nominal line voltage Option



240V, 220V, 120V, 100V ~ + 10% 240V, 230V, 120V, 100V ~ + 10%



3.4.2



Line frequency



60 Hz./50 Hz.



3.4.3



Input current at max output power



1.5A (operation at 220V, 230V, and 240V) 3.3A (operation at 100V, and 120V)



3.4.4



Rating of fuses in the main supply power



T 2.0A, 250V, Two for 240V, 220V T 4.0A, 250V, Two for 120V, 100V



SIZE AND WEIGHT 3.5.1



WxHxD



9” x 5” x 13”



3.5.2



Weight



18 lbs.



ERROR CODES TABLE DESCRIPTION



ERROR CODE



Interface to displays failed



1



Interface to LEDS failed



2



Interface to keypad failed



3



Processor had a warm reset



4



A/D converter error



7



Foot/Fingerswitch interface failed



8



Bond sensor interface failed



9



Keypad pressed during power up protection failed



10



Foot or Fingerswitch pressed during power up protection failed



11



Temperature out of limits



12



Output power test failed



13



Linear Table in Error



15



EEPROM Read



16



EEPROM Write



17



NOTE: All error messages will be reset by turning the unit off and correcting the condition.



13



IV. INSPECTION AND TEST PROCEDURE The Surgitron® 4.0 Dual RF/120 IEC unit has been thoroughly inspected and tested for proper and safe operation prior to shipment. However, all equipment should be rechecked for proper and safe operation prior to initial use. The purpose of this section is to give a guide line to check the Surgitron® 4.0 Dual RF/120 IEC unit by giving a list of the test equipment and a defined methods to perform these test.



4.1 TEST EQUIPMENT LIST 4.1.1 HARDWARE TEST EQUIPMENT 4.1.1.1 4.1.1.2 4.1.1.3 4.1.1.4 4.1.1.5 4.1.1.6 4.1.1.7 4.1.1.8 4.1.1.7 4.1.1.8 4.1.1.9 4.1.1.10



Digital Calipers Resistive Load 50 ohm/100W Resistive Load 100 ohm/100W Resistive Load 500 ohm/100W Resistive Load 1,000 ohm/100W Resistive Load 2,000 ohm/100W Low Power Resistor 330 ohm/0.25 W Low Power Resistor 1,000 ohm/0.25 W Low Power Resistor 100 ohm/0.25W Low Power Resistor 75 ohm/0.25W Low Power Resistor 10 ohm/0.25W Test Leads with Terminals



4.1.2 ELECTRONICS TEST EQUIPMENT 4.1.2.1 4.1.2.2 4.1.2.3 4.1.2.4 4.1.2.5 4.1.2.6 4.1.2.7 4.1.2.8 4.1.2.9 4.1.2.10 4.1.2.11



Digital AC True RMS Multimeter Oscilloscope Function Generator Current Sampling Transformer Digital Multimeter Digital Thermometer Variable Transformer RCL Meter High Voltage Probe Hypot Tester Electrosurgical Analyzer



14



4.2 TEST CHECKLIST 4.2.A EXTERNAL CONTROLS AND INDICATORS TEST AND INSPECTION:



No.



Test Function



A1



Turn on the unit and verify the initial tone



A2



Without any cable connection, verify the Neutral fault light is RED and the intermittent tone continues.



A3



Short the Neutral terminals with 1K ohm resistor and verify that the Neutral fault light is RED and the intermittent tone continues.



A4



Replace 1K ohm with 330 ohm and verify that the Neutral fault light is GREEN and the intermittent tone ceases. (leave the 330 ohm resistor on until instructed to remove it).



A5



Verify that both numerical displays read 0 (leave at 0). Depress FOOTSWITCH MODE selector switch repeatedly. No Footswitch Mode light indicator will be activated, they are normal OFF.



A6



Insert the footswitch connector to the rear receptacle on the rear panel. The Footswitch Mode light indicators will be activated when the footswitch is depressed.



A7



Depress CUT Footswitch to verify CUTTING MODE (YELLOW light), and verify that the lower COAGULATION MODE display shows ----- and a continuous tone sounds. The upper CUTTING MODE display should continue to display 0.



A8



Depress COAG Footswitch to verify COAGULATION MODE (BLUE light) and verify that the upper CUTTING MODE display shows ----- and a continuous tone sounds. The lower COAGULATION MODE display should continue to display 0.



A9



With any one of the footswitches, CUT/COAG, depressed, turn the unit OFF and then back on (1).



A10



Verify that the FAULT light is RED, a tone sounds and that Er11 is displayed.



A11



Release the footswitch and verify that the alarm tone and error message remain.



A12



With the footswitch released, turn the unit OFF and then back ON and verify that the alarm tone FAULT light and error message are all cleared.



A13



With the footswitch depressed, verify that there is no change on the front panel display. Release and repeat procedure.



A14



On the top CUTTING MODE, push SELECT button to select CUT (upper yellow light). Using the up arrow push button to the right of the display, verify that the displayed number increases in value. (Set it to "5".)



15



Data



Note



No.



Test Function



A15



On the top CUTTING MODE, push SELECT button to select CUT /COAG (upper yellow light). Using the up arrow push button to the right of the display, verify that the displayed number increases in value. (Set it to "7".)



A16



Repeatedly depress the SELECT push button, and Verify that the displayed value toggles between the two values previously set, i.e., 5-7-5-7......



A17



In the COAGULATION MODE - push SELECT button to select HEMO (upper blue light). Using the up arrow push button to the right of the lower display, verify that the displayed number, initially zero, increases in value. (Set it to "5".)



A18



By the same token, select FULGURATE (middle blue light) and set it to "6".



A19



By the same token, select BIPOLAR (lower blue light) and set it to "7".



A20



Repeatedly depress the SELECT push button, and Verify that the displayed previously set values are corresponding to the selected mode, i.e., HEMO-5, FULGURATE-6, & BIPOLAR-7.



A21



Connect the fingerswitch connector to the unit from the front panel for testing its function.



A22



To initialize the 3-Button Fingerswitch function depress and hold the BLEND button on the fingerswitch. Verify that the upper display shows HOLD and the lower display counts down from 3,2,1,then 0.Release the button. Both power displays return to the previous power setting.



A23



Set to the BIPOLAR mode and remove 330 ohm resistor from the NEUTRAL terminals. Verify that the alarm does not activate when the footswitch is pressed but the NEUTRAL light turns to RED.



A24



Depress the CUT button on the fingerswitch to verify that COAGULATION MODE display shows ----- and that a tone sounds. Release the button.



A25



Depress the HEMO button on the fingerswitch. Verify that the CUTTING MODE display shows ----- and that a tone sounds. Release the button.



A26



To test memory, Mode and Power output level settings that are stored and recalled as the unit is turned OFF and back ON, verify the memory with steps A16 and A20.



A27



To test for setting default values, turn the unit OFF. Press and hold both Cutting Mode and Coagulation Mode "Select" buttons simultaneously and turn the unit back ON. Verify "Clr" is seen, and all displays are zero for all modes upon release the hold.



A28



To initialize the 3-bButton Fingerswitch function, depress and hold the BLEND button on the fingerswitch. Verify that the upper display shows HOLD and the lower display counts down from 3, 2, 1, then 0. Release the button. Both power displays return to the previous power setting



16



Data



Note



No.



Test Function



A29



Note that the light indicators of CUT and CUT/COAG are alternated back forth in the standby mode waiting for the action from the fingerswtich.



A30



On FOOTSWITCH MODE, the blue light indicator is "ON" now, which sets BIPOLAR mode in standby if it is selected. The COAG footswitch control this mode. Note: The light indicators of HEMO and BIPOLAR alternate back and forth in the standby mode.



A31



To test the adjustment of the power output setting:



A32



On the top CUTTING MODE, push SELECT button to select CUT (upper yellow light), the alternation paused. Using the up arrow push button to the right of the display, verify that the displayed number increases in value. (Set it to "5".)



A33



Push SELECT button again to select CUT/COAG (upper yellow light). Using the up arrow push button to the right of the display, verify that the displayed number increases in value. (Set it to "7".)



A34



Depress the SELECT push button again to return the 3-Button Fingerswitch mode, the indicators alternated again. Verify that the displayed value toggles between the two values previously set, i.e., 5-7-5-7......



A35



With the COAGULATION MODE - push SELECT button to select HEMO (upper blue light). Using the up arrow push button to the right of the lower display, verify that the displayed number, initially zero, increases in value. (Set it to "6".)



A36



Note that FULGURATE will be skipped, because there is no FULGERATION on the 3-Button Fingerswitch handpiece.



A37



By the same token, select BIPOLAR (lower blue light) and set it to "9".



A38



Repeatedly depress the SELECT push button, and Verify that the displayed previously set values are corresponding to the selected mode, i.e., HEMO-6 & BIPOLAR-9.



A39



Depress CUT, CUT/COAG, and HEMO buttons to verify that the previously set values correspond with displayed numbers, i.e., CUT-5, CUT/COAG-7, and HEMO-6 .



A40



Turn the unit OFF and back ON to verify that all displays remain the same.



A41



To test for setting default value, Repeat step A27.



A42



To test operational duty cycle for and audio tone, activate the unit to verify the power output with the first tone for 55 seconds then another 5 seconds for the second tone before OFF. - NOT USED - NOT USED -



17



Data



Note



4.2.B



OUTPUT POWER AND WAVEFORM TEST AND INSPECTION:



(The following test is carried out with 500 ohm resistive load.) No.



Test Function



B1



CUT MODE



B1.1



Advance the CUT mode power indication to 50. Depress the footswitch and verify that the supplied power reads 88 W +/- 20%. Release the footswitch.



B1.2.



Advance the CUT mode power indication to 100. Depress the footswitch and verify that the supplied power reads 120 W +/- 20%. Release the footswitch.



B1.3.



Check the waveform of the CUT mode. It should be a continue-wave with no sign of breakup.



B1.4.



Check the waveform of the CUT/COAG mode. The envelope should look like that of a full-wave rectifier and show no sign of breakup.



B2.



COAGULATION MODE



B2.1.



Advance the HEMO mode power indicator to 50. Depress the footswitch and verify that the supplied power reads 44 W +/- 20%. Release the footswitch.



B2.2.



Advance the HEMO mode power indicator to 100. Depress the footswitch and verify that the supplied power reads 60 W +/- 20%. Release the footswitch.



B2.3.



Check the waveform of the HEMO mode. The envelope should look like that of a half-wave rectifier.



B2.4.



Check the waveform of the FULGURATE mode. It should be a series of square bursts.



C3



BIPOLAR MODE The following test is carried out with 200 Ohm resistive load



C3.1.



Advance the BIPOLAR mode power indicator to 50. Depress the footswitch and verify that the supplied power reads 87 W +/- 20%. Release the footswitch.



C3.2



Advance the BIPOLAR mode power indicator to 100. Depress the footswitch and verify that the supplied power reads 120 W +/- 20%. Release the footswitch. - NOT USED - NOT USED -



18



Data



Note



4.3



POWER OUTPUT FIGURES 4.3.1



Power Output vs. Digital Setting (500 Ohm Resistive Load)



4.3.2



Cut Mode Power Output vs. Resistive Load



4.3.3



Coag Mode Power Output vs. Resistive Load



4.3.4



Hemo Mode Power Output vs. Resistive Load



4.3.5



Fulgurate Mode Power Output vs. Resistive Load



4.3.6



Bipolar Mode Power Output vs. Resistive Load



4.3.7



Monopolar Bipolar Modes Voltage Output vs. Digital Setting



19



SURGITRON® 4.0 DUAL RF/120 IEC MONOPOLAR AND BIPOLAR MODES



Figure 4.3.1 - Power Output vs Digital Setting Monopolar 500 Ohms (Bipolar 200 Ohms) Resistive Load



NOTE: The above power chart is a typical output characteristic of the ellman Surgitron® 4.0 RF/120 IEC unit. Actual output power measurements may vary with type of test equipment used and method of circuit connection. The actual power as a function of load resistance and output control setting shall not deviate by more than +/-20%.



20



SURGITRON® 4.0 DUAL RF/120 IEC CUT MODE



Figure 4.3.2 - Power Output vs Resistive Load



NOTE: The above power chart is a typical output characteristic of the ellman Surgitron® 4.0 Dual RF/120 IEC unit. Actual output power measurements may vary with type of test equipment used and method of circuit connection. The actual power as a function of load resistance and output control setting shall not deviate by more than +/-20%.



FILE:IEC:FIG:PIEC2-02



21



SURGITRON® 4.0 DUAL RF/120 IEC COAG MODE



Figure 4.3.3 - Power Output vs Resistive Load



NOTE: The above power chart is a typical output characteristic of the ellman Surgitron® 4.0 Dual RF/120 IEC unit. Actual output power measurements may vary with type of test equipment used and method of circuit connection. The actual power as a function of load resistance and output control setting shall not deviate by more than +/-20%.



FILE:IEC:FIG:PIEC2-02



22



SURGITRON® 4.0 DUAL RF/120 IEC HEMO MODE



Figure 4.3.4 - Power Output vs Resistive Load



NOTE: The above power chart is a typical output characteristic of the ellman Surgitron® 4.0 Dual RF/120 IEC unit. Actual output power measurements may vary with type of test equipment used and method of circuit connection. The actual power as a function of load resistance and output control setting shall not deviate by more than +/-20%.



FILE:IEC:FIG:PIEC2-24



23



SURGITRON® 4.0 DUAL RF/120 IEC FULGURATE MODE



Figure 4.3.5 - Power Output vs Resistive Load



NOTE: The above power chart is a typical output characteristic of the ellman Surgitron® 4.0 Dual RF/120 IEC unit. Actual output power measurements may vary with type of test equipment used and method of circuit connection. The actual power as a function of load resistance and output control setting shall not deviate by more than +/-20%.



FILE:IEC:FIG:PIEC2-25



24



SURGITRON® 4.0 DUAL RF/120 IEC BIPOLAR MODE



Figure 4.3.6 - Power Output vs Resistive Load



NOTE: The above power chart is a typical output characteristic of the ellman Surgitron® 4.0 Dual RF/120 IEC unit. Actual output power measurements may vary with type of test equipment used and method of circuit connection. The actual power as a function of load resistance and output control setting shall not deviate by more than +/-20%.



FILE:IEC:FIG:PIEC2-26



25



SURGITRON® 4.0 DUAL RF/120 IEC BIPOLAR MODE



Figure 4.3.7 - Voltage Output vs Digital Setting Open Circuit (No Load)



NOTE: The above voltage chart is a typical output characteristic of the ellman Surgitron® 4.0 Dual RF/120 IEC unit. Actual output voltage measurements may vary with type of test equipment used and method of circuit connection. The actual voltage as a function of output control setting shall not deviate by more than +/-20%.



26



V. STRUCTURE OF SURGITRON® UNIT Item



Description



Drawing No.



Revision



Note



1



IEC -3 Enclosure



080-901



10-01



1/12



2



IEC -3 Display Board



080-901



10-01



5/12



3



IEC -3 Mounting Speaker



080-901



10-01



2/12



4



IEC -3 Top Enclosure



080-901



10-01



3/12



5



IEC -3 Assembly Matching Board



080-901



10-01



4/12



6



IEC -3 Assembly Main Board



080-901



10-01



6/12



7



IEC -3 Assembly Bottom Enclosure



080-901



10-01



7/12



8



IEC -3 Cable Assembly



080-901



10-01



8/12



9



IEC -3 Power Assembly



080-901



10-01



9/12



10



IEC -3 Assembly Drawing



080-901



10-01



10/12



11



IEC -3 Assembly Drawing



080-901



10-01



11/12



12



IEC -3 Overlay Drawing



080-901



10-01



12/12



- NOT USED - NOT USED - NOT USED -



27



VI. PARTS LIST Item



Description



Parts Number



Quantity



1



Bottom Cover



IEC3-ENB-001



1



2



Top Cover



IEC3-ENT-002



1



3



Rear Case Panel



IEC3-ENR-003



1



4



Assemble Main Board



IEC3-MPC-004



1



5



Assemble Matching Board



IEC3-CPC-005



1



6



Assemble Display Board



IEC3-DPC-006



1



7



Speaker



IEC3-SPK-007



1



8



Power Transformer



IEC3-XFM-008



2



9



Power Supply System



IEC3-PSS-009



1



10



Input Power Modular



IEC3-IPM-010



1



11



Power Switch



IEC3-PSH-011



1



12



3-p Footswitch Cable



IEC3-FSC-012



1



13



3-p Audio Cable



IEC3-AUC-013



1



14



5-p Power Cable



IEC3-PWC-014



1



15



10-p Audio & Sensor Cable



IEC3-ASC-015



1



16



10-p Display Cable



IEC3-DSC-016



1



17



4-p RF Cable



IEC3-RFC-017



1



18



2-p Neutral Cable



IEC3-NTR-018



1



19



Rubber Mount



IEC3--RBF-019



4



20



Mounting Screw



IEC3-MTS-020



8



21



Volume Control Knob



IEC3-VCK-021



1



22



Footswitch Receptacle



IEC3-FSR-022



1



23



Overlay



IEC3-OVL-023



1



- NOT USED -



28



Note



29 Part 2 Top Cover Bottom View



Part 1 Bottom Cover



Title 120-IEC Enclosure Drawing No. 3-080901 Sheet: Scale: Rev. 1 of 12 1:1 1001 Drawn by Myriatha St-fleur 3/5/01



Part 3 Rear Panel



30 Title 120-IEC Mounting Speaker Drawing No. 3-080901 Sheet: Scale: Rev. 2 of 12 1:1 1001 Drawn by Myriatha St-fleur 3/5/01



Part 4 Speaker



31 Title 120-IEC Top Enclosure Drawing No. 3-080901 Sheet: Scale: Rev. 3 of 12 1:1 1001 Drawn by Myriatha St-fleur 3/5/01



Part 2 Top Cover



32



Part 5 Matching Board



Part 18 2 Pin Neutral Cable



Drawing No. 3-080901 Rev. Scale: Sheet: 1001 1:1 4 of 12 Drawn by 3/5/01 Myriatha St-fleur



120-IEC Assembly Matching Board



Title



33 Part 6 Display Board



Part 6 Display Board



Part 16 10 Pin Display Cable



Title 120-IEC Display Board Drawing No. 3-080901 Rev. Scale: Sheet: 1001 1:1 5 of 12 Drawn by 3/5/01 Myriatha St-fleur



34



Part 4 Main Board



Part 16 10 Pin Display Cable



RV301



Part 17 4 Pin RF Cable



Connected to Part 13 Audio Cable



TP301 Connected to Part 12 3 Pin Foot Switch Cable



Title 120-IEC Assembly Main Board Drawing No. 3-080901 Rev. Scale: Sheet: 1001 1:1 6 of 12 Drawn by 3/5/01 Myriatha St-fleur



Part 15 10 Pin Audio And Sensor Cable



Connected to Part 14 5 Pin Power Cable



35



TP4



Speaker



TP2



RV1



Bottom Cover



RV2 TP3 TP1



Title 120-IEC Cable Assembly Drawing No. 3-080901 Rev. Scale: Sheet: 1001 1:1 7 of 12 Drawn by 3/5/01 Myriatha St-fleur



E1



E2



Matching Board



36



Part 14 5Pin Power Cable



Part 8 Power Transformer Part 12 3 Pin Foot Switch Cable



Title 120-IEC Cable Assembly Drawing No. 3-080901 Rev. Scale: Sheet: 1001 1:1 8 of 12 Drawn by 3/5/01 Myriatha St-fleur



Part 7 3 Pin Audio Cable



37



Part 9 Power Supply System



Title 120-IEC Power Assembly Drawing No. 3-080901 Sheet: Scale: Rev. 9 of 12 1:1 1001 Drawn by Myriatha St-fleur 3/5/01



Display Board



38



Part 10 Input Power Modular



Part 11 Power Switch



Title 120-IEC Assembly Drawing Drawing No. 3-080901 Rev. Scale: Sheet: 1001 1:1 10 of 12 Drawn by 3/5/01 Myriatha St-fleur



Display Board



Main Board



39



Top Cover



Part 9 Rubber Mount (4 Pls)



Title 120-IEC Assembly Drawing Drawing No. 3-080901 Rev. Scale: Sheet: 1001 1:1 11 of 12 Drawn by 3/5/01 Myriatha St-fleur



Display PC Board



Part 20 Screw (11Pls)



40



CUT/C OAG CUT/COAG



CUT CUT



FINGERSWITCH / HANDPIECE



BIPOLAR BIPOLAR



FULGURATE FULGURATE



HEMO HEMO



COAGULATION COAGULATION MODE MODE SELECT SELECT



120 IEC IEC 120



INDICATOR MODE



FOOTSWITCH FOOTSWITCH



SELECT SELECT



CUTTING CUTTING MODE MODE



BIPOLAR HANDPIECE



POWER



ENERGIZED



POWER



ENERGIZED



ON/OFF



!



Title 120-IEC Front Panel Drawing No. 3-080901 Rev. Scale: Sheet: 1001 1:1 12 of 12



NEUTRAL



NEUTRAL NEUTRAL



FAULT FAULT



4.0 Dual RF



ellman llman



ERROR CODES TROUBLESHOOTING TABLE ERROR CODE



DESCRIPTION



CORRECTIVE ACTION



1



Interface to displays failed



Replace Display Board



2



Interface to LEDS failed



3



Interface to Keypads failed



Replace Overlay Keypad. If this does not correct error then replace Display Board



4



Processor had warm reset



Re-Seat Processor. If this does not correct error then replace MAIN BOARD and the MATCHING AND SENSING BOARD *



5



N/A



6



N/A



7



A/D converter error



Re-Seat Processor. If this does not correct error then replace MAIN BOARD and the MATCHING AND SENSING BOARD *



8



Footswitch/ Fingerswitch



Perform calibration of Footswitch and Fingerswitch If



interface failed



this does not correct error then replace MAIN BOARD and the MATCHING AND SENSING BOARD *



9



Bond sensor interface failed



Perform Calibration of Bond Sense If this does not correct error then replace MAIN BOARD and the MATCHING AND SENSING BOARD *



10 11



Keypad pressed during



Replace Membrane Board. If this does



power up protection failed



not correct error then replace Display Board



Footswitch/ Fingerswitch pressed



Replace Footswitch or Fingerswitch and cables



during power up protection failed 12



Temperature out of limits



Turn off unit and allow to cool down



13



Output power test failed



Replace MAIN BOARD and the MATCHING AND SENSING BOARD *



14



N/A



15



Linear Table in Error



16



EEPROM Read



17



EEPROM Write



Re-Seat Processor and EEPROM. If this does not correct error then replace MAIN BOARD and the MATCHING AND SENSING BOARD *



*The MAIN BOARD and the MATCHING AND SENSING BOARD is a Matched Set and must be replaced together.



41



ALIGNMENT PROCEDURES FOR THE SURGITRON® 4.0 DUAL RF/120 REQUIRED EQUIPMENT NEEDED The following Equipment is required in the testing and alignment of the SURGITRON® 4.0 DUAL RF/120 ITEM



Description



Qty



Manufacturer



Manufacturer P/N



1



8-inch Neutral jumper



1



2



8- inch Handpiece jumper



1



3



Digital Multimeter



1



Fluke



4



Digital Oscilloscope



1



Tektronix



5



High Voltage Scope Probe X100



1



Tektronix



P5100



6



330 Ohm _ watt Resistor



1



7



1k Ohm _ watt Resistor



1



8



Viskay Power Resistor, 500 Ohm, 250 watt



1



Viskay/Dale



NH250500R0FJ01



9



Electrical Safety Analyzer



1



Fluke Biomedical



EIC601



10



Electrosurgery Performance Analyzer



1



Fluke Biomedical



RF303RS



Vendor



Vendor P/N



Mouser



71-NH250-500



DC VOLTAGES 1. Disconnect the connector on J601. 2. Confirm with a DVM the DC voltage between Pins 1 to 2 of the connector is 28 Volts. 3. Confirm with a DVM the DC voltage between Pins 3 to 6 of the connector is 36 Volts. 4. Confirm with a DVM the DC voltage between Pins 4 to 6 of the connector is 18 Volts. 5. Confirm with a DVM the DC voltage between Pins 1 to 6 of the connector is 56 Volts. 6. Reconnect the J601 Connector BOND SENSE CALIBRATION 1. Place a 330W Resistor across into the Ground Plate (neutral) connector J2-1 and J2-2 on front panel of Unit. 2. Monitor the voltage between TP2 and TP4 (Ground) of the Matching and Sensing Board with a DVM. 3. Adjust RV1 to 3.2 Volts. 4. Replace the 330W Resistor with a 1KW Resistor. 5. Monitor the voltage between TP2 and TP4 (Ground) with a DVM and confirm that the voltage present is 3.7 Volts.



42



FOOTSWITCH CALIBRATION 1. Set the Power Levels for Cutting Mode and Coagulation Mode to Zero. 2. Monitor the voltage between TP301 and Q201 E2 (Ground) of Main Board with a DVM. 3. Press the CUT Footswitch. 4. Adjust RV301 to 2.9 Volts. 5. Press the COAG Footswitch and confirm that the voltage is 1.6 Volts. 6. Confirm that the voltage is 4.5 Volts with Neither the CUT or COAG Footswitches Pressed.



FINGERSWITCH CALIBRATION 1. Set the Power Levels for Cutting Mode and Coagulation Mode to Zero. 2. Connect the Fingerswitch Probe Pin 1 to E1 and Pin 2 to E2 of the Matching and Sensing



Board using 2



(two) Alligator clip jumpers. 3. Monitor the voltage between TP1 and TP3 (Ground) of the Matching and Sensing Board with a DVM. 4. Press the CUT Fingerswitch. 5. Adjust RV2 to 3.1 Volts. 6. Press the COAG Fingerswitch and confirm that the voltage is 3.8 Volts. 7. Press the HEMO Fingerswitch and confirm that the voltage is 1.6 Volts. 8. Confirm that the voltage is 4.5 Volts with Neither the CUT, COAG or HEMO Fingerswitches Pressed.



ALTERNATE PERFORMANCE PROCEDURES FOR THE SURGITRON® 4.0 DUAL RF/120 Using an RF303RF Electrosurgery Performance Analyzer or equivalent check out the Bipolar output of the SURGITRON® 4.0 DUAL RF/120 conforms Figure 4.3.1 Since Electrosurgery Performance Analyzers are not calibrated for measurements at 4 MHz, Monopolar performance must use the following procedure: 1. Connect a 500-ohm load to the IEC using the 8-inch Jumpers and connect the P5100 High Voltage Scope Probes across the 500-ohm load.



**Caution: do not use a normal scope probe as it could result in damage to the oscilloscope.



2. Measure the Peak Volts across the 500 ohm load and confirm using the table below that the unit is within limits. Percent Power



Output Power (Watts)



Peak Volts



Limits



0



0



0



0



0



5



15



122



110



331



10



26



161



144



380



15



36



190



170



412



20



45



212



190



436



25



53



230



206



454



30



60



245



219



468



40



73



270



242



492



50



85



291



261



511



60



95



308



276



525



70



103



321



287



536



80



109



330



295



544



90



115



339



303



551



100



120



346



310



557



Using an EIC601 Electrical Safety Analyzer or equivalent check that the SURGITRON® 4.0 DUAL RF/120 is within limits for Electrical Safety as per IEC60601



Rules to Prevent damage to the IEC3a Unit 1. Never run unit for long periods of time over 30∞ C. When the transistor reaches 40∞ C damage will occur 2. Check Mono-polar and Bi-polar at 5% power to check for output. 3. When using the 500W load on Mono-Polar Mode, Start at 5% power. Then slowly increase Power 4. Never let the load resistor become too hot, it will cause them to fail



44



45



49



50



NOTES



0413



BM-543-f