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    Conmed 2500 Service Manual PDF

    Uploaded by

    Serkan Öztürk

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    © All Rights Reserved
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    SESTEN Z500° ELECTROSURGICAL a BASS fice Gana MANUAL ERRATA MODEL: System 2500 MANUAL P/N: 60-8013-ENG REVISION LEVEL: C | ECN NO.: 8360 DATE: 04/12/04 EFFECTIVITY: Effective for all units. DESCRIPTION Section 2.4.2, Item 21 - Change the wording to read as follows: ReadiPlug™ UNIVERSAL ACCESSORY RECEPTACLE: This receptacle accepts accessory cables equipped with standard active (Bovie #12) plugs, standard 4mm banana plugs or pintip style dis- posable connectors without the necessity of special adapters. + Banana plugs can be inserted and removed directly without pushing the button. + To insert a Bovie #12 plug, you must push the button adjacent to the receptacle, insert the plug fully and release the button. IMPORTANT: When removing a Bovie #12 plug, you must press the button while pulling the plug out, + When handling the pin-tip style plug, hold the wire about 3 inches (7.6 cm) from the tip and push the button while inserting the tip. IMPORTANT: Verify proper insertion by tugging gently on the plug to ensure that the ReadiPlug™ mechanism has properly retained the tip. To remove the pin-tip, you must press the button while pulling the plug out. This receptacle can only be activated by the monopolar footswitch. WARNING NEVER CONNECT MORE THAN ONE ACCESSORY AT A TIME TO THIS RECEPTACLE, The revision level of this manual is specified by the highest revision letter found on either the inside front cover or enclosed ERRATA pages. FORM 900-328 REV. - 12167 MANUAL ERRATA MODEL: System 2500 MANUAL P/N: 60-8013-ENG REVISION LEVEL: B_ | ECN NO.: 8211 DATE: 01/05/04 EFFECTIVITY: ALL UNITS. DESCRIPTION: Replace the table with the one shown: 1.2.11 Operating Modes and Nominal Output Parameters ‘Mode Max | RawedLoud [pial [MacOpen | MovLoaded | Cawier | Dubbe Power | (ohms) | Grae | Cree Volage | Votege Peak) | rey Repetition (eats) Recor | 5) (kHa* | Rreq(kta) ‘Monopcle PureGu [300 | 500 1417 _[ 300) 0 BL NA Blew 2 180 | 500) 15-19 _| 860 230 21 200) Bend 2 20 | 500 1sn24_[ 00 1100 31 200) Blend 3 a0__[ so 24-29 _[ 80 1480 31 200) Pinpoint Cong | 120 | $00 37-46 | 2120 200 2 20.0 Standard Ooag [120 [$00 56-66 | s140 3500) 562 wo Spay Coax | #0 | $00 7-97 _| «350 (6350 56, 198 polar Macro Gong [70 [300 16-20 [ao a0 oa NA The revision level of this manual is specified by the highest revision letter found on either the inside front cover or enclosed ERRATA pages. FORM 900-328 REV.- 12/87 MANUAL ERRATA MODEL: System 2500 MANUAL P/N: 60-8013-ENG REVISION LEVEL: A | ECN NO,: 8108 DATE: 8/26/03 EFFECTIVITY: All units. DESCRIPTION: ‘Add the folowing statements fo Section 1.1.4 Cautions for Testing or Servicing: "Improperly connecting test equipment can cause electric shock and destruction of equipment.” “Turn unit Off and wait unt storage capacitors have discharged before connecting test equipment.” "WARNING: LOSS OF POWER SUPPLY ISOLATION CAN CAUSE ELECTRICAL SHOCK. WHEN SERVICING ‘THE HIGH VOLTAGE POWER SUPPLY, ASSUME INTERNAL ISOLATION IS COMPROMISED UNTIL VERIFIED OTHERWISE." Revise Section 2.3.1 Proliminary Functional Tosting, step 13 as follows: ‘WAS *..and confirm that an Acc error appears on the display.” NOW... and confirm that the yellow Cut Mode indicator extinguishes, the blue Coag Mode Indicator illuminates and the activation tone changes from Cut to Coag.” ‘Add Section 4,8.7 Output Coupling Capacitor Check as follows: WARNING: ENSURE ALL POWER SETTINGS ARE AT 0 WATTS BEFORE CONDUCTING THIS TEST TO PREVENT INJURY TO PERSONNEL AND DAMAGE TO TEST EQUIPMENT, NOTE: Not all capacitance meters will read properly for this test. The test frequency should be at or below 1 kHz for best accuracy. The following meters have been tried successfully: Fluke 189, Extech 285, Sencor LC7S and HP4284A, (1 kHz setting or below). 41. Connect shorting piug fo banana adapter to the two pin Dispersive Electrode Receptacle, Use 6” or less {est leads to connect a capacitance meter botwoen the shorting plug adapter and the footswitched ReadiPlug™ Universal Accessory Receplacie, 2. Measure capacitance and confirm itis less than 0.5 nF. 3. Confirm out povrer is set to 0, then activate and confirm capacitance is between 4.3 and 6.3 nF. 4, Do not activate for this bipolar test. Move test leads to Bipolar Output Accessory Receptacies. Confirm capacitance Is between 9.6 and 14 nF. ‘Add the following statement to Section 4.11.1 HVPS Troubleshooting Hints: “WARNING: LOSS OF POWER SUPPLY ISOLATION CAN CAUSE ELECTRICAL SHOCK. WHEN SERVICING ‘THE HIGH VOLTAGE POWER SUPPLY, ASSUME INTERNAL ISOLATION IS COMPROMISED UNTIL VERIFIED OTHERWISE” ‘The revision level of this manual is specified by the highest revision letter found on either the inside front cover or enclosed ERRATA pages. FORM 800-328 REV. - 1287 Section SYSTEM 2500" Table of Contents & List of Unstrations Title General Information. Cautions. anions For Equipment Preparation Cautions For Patient Preparation. Cautions Bor Use... Cautions For Testing oF Servicing. Specifications... Mains Overcurrent Protection Mains requency Leakagy Regulatory Compliance... Operation... : Power Display Accu Line Regulation .. Environmental Contact Quality Monitor Audio Specifications Other Specifications Operating Modes and Nominal Ousput Parameters. Explanation of Symbols Control Panel Interior. Ourpu/Controt Panel. Rear Panel Output Chacacteri Installation and Operation Initial Inspection, Installation... Installation OF Fuses, ity Checks inary Functional Testing Preliminary Performance Testing Controls, Displays and Connectors Control Panel... Output Panel. Rear Panel ‘Set Up For Use. Operation Remote Power Control e ‘Changing Monopolar Power Remotely... User Maintenance. i General Maintenance Information Cleaning, Pesiodie inspection... Periodie Performance Testing In Case of Difficulty Cur 7 200 TTD Section Title 28.1 Dispersive Electrode Alarm . 2811 ingle Dispersive Electrode Alarm 28.12 Dual Dispersive Blectrode Alarm 28.2 ‘Ace Codes. : 28.3 Ber Codes sa 284 IFAll Else Fails Environmental Protection . "Theory of Operation ... “Mode Descriptions. Cut Major Modes. COAG Major Modes Bipolar Major Modes System Overview High Voltage Power Supply (HVPS) RE Amplifier and Transformer Electrosurgical Outputs nm Activation Command Sensing. Automatic Return Monitor (A.M. Low Voltage Power Sources... System Controllers and Monitor. Low Voltage Power Monitoring. Operator Control Panel Activation Tones, Activation Relay Connector... Optional System Configurations.. 40 ‘Maintenance nnn 4 General Maintenance Information. 42 Maintenance Personnel . 43 “Assembly Breakdown and Parts Access. 43.1 “Top Cover Removal and Replacement 432 Bezel Removal and Replacement... 433 Processor Board Removal. 434 ‘Transformer Board Removal and Replacement. 435 ‘Output Board Removal and Replacement, 43.6 RE Amp Boatel Removal and Replacement .. 437 Low Voltage Power Supply Modile Removal and Replacement. 43.8 High Volage Power Supply Removal and Replacement: 43.9 Rear Panel with Board Removal and Replacement... 43.10 Back Panel Board Removal and Replacement sen 4311 Display Board Removal and Replacement oe teree) 43.12 Power Transistor Replacement, se $10 44 Cleaning 7 au 45 Periodic Inspection. i etal 46 Pevilc Performance Testing. se oer an 46.1 Chassis Ground Tntegtity ae au 46.2 Displays, Alarms and Commands... : 411 46.3 Ontput Power. tenne oL 4.6.8 RF Leakage Measurement 413 46.5 Line Frequency Leakage... 415 46.6 Automatic Return Monitor (A.R.M, 417 snes 417 418 47 System Calibrat Calibration Preliminat es | Section Title Page 472, Selecting the Mode to Calibrate. z +18 478 Calibrating a Monopolar Mode «... sree 418 474 Calibrating Bipolar Modes, 4:20 475 Calibrating A.R.M."".. 4-20 476 Completing Calibration... 4-21 48 Last Fault Code Retrieval and Cleat 1421 48.1 Last Fault Code Retrieval sown s aa aL 48.2, Cleating Last Fault Codes sono : 422 49 Displaying Optional System Configuration, 422 410 DAGYieW on 424 ail ‘Troubleshooting... eee sommes D6 ALLL HIVPS Troubleshooting Hints : : 4.29 412 Parts Ordering Information... soe $30 413 Fault Codes, Parts Lists, PCB Layouts & Schemas sees BO Tables ‘ible 4.1 Monopolar Cut Mode RF Output Power Accuracy. ‘Table 42 Monopolar Coag Mode RF Output Power Accuracy ‘ible 43 Bipolar Mode RE Output Power Accuracy ono Tible44 Allowable RF Leakage Current to Ground. ‘Tble45 Allowable RE Leakage Current - Inactive Monopolar Outputs. Tible4.6 Allowable RF Leakage Current - Inactive Bipolar Outputs... Table 4.7 Line Frequency Allowable Leakage - Inactive. : Table 4.8 Line Frequency Allowable Leakage - Active . Table 4.9 DIP Swe Settings. ‘Thble 4.10 DACview Channels. Table 4.11 Troubleshooting... Table 4.12 Fault Codes... 37 2 II Section Figures & Schematics Kigure 1.1 Figure 12 Figure 1.3 Figure 14 Figure 1.5 Figure 16 Figure 1.7 Figure 18 igure 2.1 Figure 22 Figure 2.3 Figure 24 Figure 2.5 Figure 3.1 Figure 32 Figure 4.1 Figure 4.2 Figure 4.3 Schematic 4.1 ‘Schematic 4.2 Vigure 4.4 Schematic 4.30 Schematic 4.31 Figure 4.5 Schematic 44 Figure 4.6 Schematic 4.5 Figore 4.7 Schematic 4.68 Schematic 4.6b Figure 4.8 Schematic 4.74 Schematic 4.7b Figure 4.9 Schematic 4.8 Figure 4.10 Title Page Ouuput Power vs, Power Setting... : 1-10 Display vs. Open Circuit Peak Voltage. : 1-10 Load Regulation, Monopolar Pare Cut z : ail Load Regulation, Monopolar Blend 1 jarsurneunaninnsenninnanannenesnnanenn ELL Loxd Regulation, Monopolar Blend 2... eee eld Load Regulation, Monopolar Blend 3 ones VAD Load Regulation, Monopolar Pinpoint Coagonrnnnnninsnnnnne E18 Load Regulation, Monopolar Standard Coag Load Regulation, Monopolar Spray Coag Load Regulation, Bipolar. Control Panel. we ‘Onaput Panel Rear Panel . ‘Accessory Schematis oy Accessory Connections snr RE Coniroller Block Diageam System Block Diagram so Calibration Procedure Flow Chart wn DIP Switch Positions ssn ‘Module Diagram Interconnect Diag ‘A12 Back Panel PCB... AI2 Back Panel PCB Assembly. : ‘A9 RE Power Supply PCB ~ Power Factor Controller AY RE Power Supply PCB - Forward Converter anu 9 RE Power Supply PCB Asemby. RF Transformer PCB... AT RF Transformer PCB Assembly A6 RE Amplifier PCB AG RE Amplifier PCB Assembly . A5 RE Outpuc PCB - Interconnect & Switching Isolation... ‘AS RE Output PCB - Relays & Sensing... AS RE Output PCB Assembly. fe ‘Ad Microcontroller PCB - Controller Inte ‘A4 Microcontroller PCB - Microcontroller ‘Ad Microcontroller PCB - RF Controller .. ‘Ad Microcontroller PCB - RE Monitor ‘Ad Microcontroller PCB Assembly A2 Display PCB... : A2 Display PCB Assembles a le SYSTEAM 2500" ‘This manual provides the set up and operating instructions fhe the System 2500” Elerosurgical Unit (ESU). Blectrosurgery can be dangerous to patients staf¥and other equipment if misused: Please understand andl follow the wamiings and cautions that are included in this manta nical specifications, performance chat ayes an user maintenance instruct inches ‘The System 2500” provides a broad range of capabilities in a single, general-purpose clectrosmigical generator. “This rugged ESU fulfills the operational and safety needs of the modern operating room by providing: + Four monopolar cutting modes: Pure Cut, Blend 1, Blend 2 and Blend 3. + Three monopolar coagulation modes: Spray, Standard and Pinpoint, * One bipolar mode, + Radio Frequency (RE) isolated and independent outputs * The proven Automatic Return Monitor (A.R.ML) contact quality monitoring syst * Continous Features incade: ae + Energy Synchronous Processing Technology delivers optimal clinical effects in all operational ‘modes through the continuous synchronization of current and voltage. + ReadiPlug"™ universal accessory receptacle elimi- nates the need for foot-controlled adapters. * Automatic programming restores the ESU to the last settings used. * Remote Power Control (PC) allows power setting changes using standard band contoled pencib, * Independent power setting available for all modes. * Ability to change power settings fiom the con- trol panel while the ESU is activated. « Two handswitched receptacles and a separate footswitched receptacle enable multiple accessory * Simuitancous activation tion modes. Channeled accessory receptacles direct plugs into position, making actachments less cumbersome * Integrated interface for activation of smoke cevacuators and similar devices. ‘monopolar congula- General Information Scetion 1.0 1.1 Cautions his equipment, in conjunction with connected accessories, is intended to procluce high-frequency clectrical energy for the controlled destruction of tissue. Safe and effective electrosurgery is dependent not ‘only on equipment design, but also on factors un. der the control of the operator. It is important that the instructions supplied with this equipment be read, understood and followed in order to ensure safe and effective use of the equipment. 1.1.1 Cautions For Equipment Preparation * Use only accessories that meet the requirements of Section 1.2, Section 14, and Figure 2.4 + Reusable accessory cables should be periodically function and safety tested in accordance with the original manufaettuer’sinstrtctions. + Visually inspect all accessories before cach use to. verify the integrity of insulation and the absence of obvious defects. In particular, electrode cables ancl endoscopic accessories should be checked for dam- age to the insulation, + The System 2500™ is equipped to connect three anonopolar accessories at one time for the conve~ niience of the surgical staf, Unused accessories should be stowed in a safe, electrically insulated place such as a non-condnetive holster, isolated fiom the patient. CONMED recommends acces- sories not be connected unless needed. + Never connect miore than one accessory at atime to any one receptacle. + Use only a hospital grade, 3-prong, power cord rated to meet the specifications in Section 1.2 an all of the requirements for safe grounding of the ESU. ‘The nser should verify that the power receptacle with whieh this ESU is used is property rounded, comectly polarized and of che proper frequency per Section 1.2. Do not use ground cheater plugs or extension cords Ee | 7 2 + Do not place iquidl containers on top ofthe ESU. Wipe spilled liquids off the ESU immediate- To preclude inadvertent entry of liquids, do not SU except in its normal position, + Do nor stack other devices or equipment on top of the System 2500". ‘The CONMED Stacking ‘Adapter (Cat. No. 60-8030-001) allows two Sy tem 2500™ or System 5000™ units to be stacked in a safe manner. + Confirm all accessories are properly connected to the appropriate receptacles before powering the ESU. + Potentially hazardous conditions may exist when accessories of similar connector types are combined, Be certain accessories are appropriate for the type of generator output used. Use onl CONMED Electrosurgery footswitches. Confirm bipolar leads are connected only to the bipolar receptacles. Connecting bipolar accessories to ‘monopolar outputs may result in patient injury * Do not reuse disposable (single use) accessories. * Do not use cords as handles as damage to the insulation and increased risk of burns or other injury may result + A failure in the BSU could cause an unintended crease in output power. Verify that the ESU functioning correctly prior to use, + Prior to use, verify that devices connected to the Activation Relay Connector function properly in ‘a manne that is synchronized with ESU power delivery 1.1.2 Cautions For Patient Preparation lectrosurgery should NEVER be performed in the presence of flammable anesthetics, flammable prep solutions or crapes, oxidizing guses such as Nityous Oxide (N,O) or in oxygen-cnriched envi ronments. The tisk of igniting flammable gases or other materials is inherent in electrosurgery and cannot be eliminated by device design. Precautions must be taken to restrict flammable materials and substances fiom the electrosurgical site. They may be present in the form ofan anesthetic, life sup- por, skin preparation agent, produced by natural processes within body cavities oF originate in I drapes, tracheal tubes or other materials ‘There isa risk of pooling of flammable solutions in body depressions such as the umbilicus and in body cavities, such as the vagina, Any fluid pooled in these areas should be removed before the high frequency surgical equipment is used. Due to the danger of ignition of endogenous gases, the bowel should be purged and filled with nonflamnmable {g98 prior to abdominal surgery. ‘To avoid the risk of teacheal fires, never use clectrosungery to enter the trachea during tracheotomy procedures + The System 2500" cart is made of nonconductive plastic that can hold a static charge Trshould not be sed in a flammable environment, as described above. + Only non-flammable agents should be used for cleaning and disinfection wherever possible. + Exercise care when relocating the ESU to avoid electrostatic charge buildup in the presence of flammable materials, as there isa risk of igniting these materials ifa spark should occur: + This ESU is equipped with the Automatic Re- tum Monitor (A.R.M,), which monitors the qual- ity of the dispersive electrode connection. When a correctly functioning single dispersive electrode is connected to the ESU, A.R.M. verifies the con- nections between the ESU, the dispersive electrode cable and the dispersive electrode. It DOES NOT verify that a single dispersive electrode is in contact ‘with the patient. When using a dual dispersive electrode, A.R.M. confirms the total resistance is, ‘within the preset safety range. Proper application and visual inspection of the dispersive electrode is required for safe operation, + ‘The use and proper placement of a dispersive clectrode is a key element in safe and effective clecteosurgery. Follow manufacturer's directions and recommended practices for the preparation, placement, use, surveillance and removal of any dispersive electrode supplied for use with this ‘electrosurgical unit + Apply the dispersive electrode over a well-vascu- Jhvized muscle mass that is thoroughly clean and dry: Clean and shave site, as necessary, to provide adequate electrical connection and per hospital policy. Avoid placement over sear tissue, bony’ prominences or other areas where presstre points ‘on small ateas might develop. es | ee «76 2 * Because of the risk of burns, needles should never be used asa dispersive electrode for lectrosurgery: ‘The entire atea of the dispersi 30 / 20 20 10 e Output Power (Warts) 0 500 1000 1500 2000 Load Resistance (Ohms) Figure 1.6 Load Regulation, Monopolar Blend 3 EE 4 es | 140 120 120 100 80 60 40 Output Power 20 0 500 1000 1500 2000 Lond Resistance (Ohms) Figure 1.7 Load Regulation, Monopolar Pinpoint Coag 140 + 120 120 100 80 60 40 Ourput Power (Wares) 20 ° 500 4000 1500 2000 Load Resistance (Ohms) Figure 1.8 Load Regulation, Monopolar Standard Coag, EE 4 7 2 Ie 90 80 4 70 60 50 40 30 ‘Ourpue Power (Watts) 20 10 0 0 500 1000 1500 2000 (Output Power (Watts) Load Resistance (Ohms) Figure 1.9 Load Regulation, Monopolar Spray Coag ° 200 400 600 800 1000 Lond Resistance (Ohms) Figure 1.10 Load Regulation, Bipolar a | S¥STEM 2500™ Installation and Operation Section 2.0 ‘This section comains initial installation, preliminary checks andl operating instructions for the System 2500" 241 Initial Inspection Unpack the FSU upon receipe and physically inspect it for any obvious damage that may have ‘occurred ducing shipment. A qualified biomedical engineer should perform this inspection. Notify the carrier anc your CONMED representative mediately if damage is found. 2.2 Installation ‘The ESU may be mounted on a matching cart or any stable eat or table 2.2,1 Installation Of Fuses Ourside of the U.S., proper fuses must be installed prior to connection vo any power source. Install fases in the following manner a) Ensure the power cord is disconnected fiom the ESU. b) Locate the fses that are packaged with the ESU. ‘There will be three sets of fuses provided: + 8.0,A for installations with nominal mains voltages of 100 VRMS (Part number 62-4236- 800). + 6.3 A for installations with ‘nominal mains voltages of 115 VRMS (Part number 62-4236. tallation with s voltages of 230, RMS or greater (Part number 62-4236-315). Choose the correct fuses for the mains voltage in the location where the ESU will be used. ©) Usea flat blade screwdriver to remove the covers from each of the two FUSE RECEPTACLES by turning the covers, approximately % turn to the left. d) Insert one of the chosen fuses in each of the two FUSE RECEPTACLE covers. ©) Re-insere the two FUSE RECEPTACLE. covers, with fuses installed, into the FUSE, RECEPTACLES, f) Use a flat blade screwdriver to gently push cach of the two covers into the FUSE RECEPTACLES and rotate each one approximately Y tarn to the right to lock them in place. g) Connect the power cord to the back of the ESU. Instalhtion of the FSU may now be completed, WARNING "HE POWER CORD OF THE ESU SHOULD BE CONNECTED TO A PROPERLY POLARIZED AND. GROUNDED POWER SOURCE, WHOSE VOLTAGE AND FREQUENCY CHARACTERISTICS ARB COMPATIBLE WITH THOSE LISTED ON ‘THE ‘NAMEPLATE OF THIS ESU. CAUTION: Since the ESU depends on both natural convection and forced air for cooling, it should not be installed in a cabinet or similar enclosure. If mounted on a shelf or otherwise near a wall, allow a two-inch clearance around and above the ESU to permit free circulation of air along the sides of the ESU. 2.8 Preliminary Checks Prior to inital installa performance of the device should be tested in accordance with this manual. Results of th testing should be compared to the results tabulated con the factory Test Data Sheet supplied with ea ESU. This data should be retained for fture reference ancl comparison. ES |? 57 I, 2.3.1 Preliminary Functional ‘Testing “The following checks are recommended upon initial installation of the equipment anc prior to cach use of the instrument to avoid unnecessary delays in surgery. See Figure 2.1 for location of controls and connectors. 1. Ensute the power switeh is OFF and no. accessories are connected, 2. Connect the power cable to a properly ‘grounded and polarized mating power receptacle of the proper voltage and frequency. 3. Connect a CONMED duat-treadle monopolar footswiteh and a single treadle CONMED bipolar footswitch to their mating connectors at the rear of the ESU. Note: Use only CONMED Blectrosurgery footswitches. Although other types may fit, they may not be funetionally compatible 4. Make no connection to the dispersive electrode receptacle at this time, Set the Power Switch to the ON (“|”) position, As the ESU goes through the internal self diagnostics, it should respond by 8) Sounding a series of test tones. b) During the test tone, displaying a total of eight “8” on the three digital displays ©) Illuminating all three mode indicators, all eight key indicators, two dispersive electrode indicators and the entire dual dispersive electrode contact quality BARGRAPH. 4d) After the display test, the ESU will show the software revision level in the COAG display window. The ESU is conducting a power-on selFtest during this interval. ©) Ifthere are no errors, normal operational parameters will then be displayed. 6. Depress the Cut treadle of the monopolar footswitch, ‘The dispersive electrode alarm should sound and dispersive electrode indicators should flash alternating red. While holding the Cut treadle, rorate the volume control over its fall range and verify there is no significant change in sound level. Release the Cut footswitch and the tone should stop. 10, Select each of the modes by pressing the mode Select Keys and note the displayed power settings for each mode in the corresponding: displays, Verify that the Pure Cut mode can be selected and adjusted up and down by: Pressing the Pure Cut Seleet Key and verify that the Pure Cut Indieator is illuminated Pressing the Monopolar Cut Power Adjustment Keys to increase and decrease the setting while verifying that the display changes appropriately and verifying that no other displays change. Pressing the other mode Select Keys anc verifying that the settings for each of the other modes were not changed by changing the Pure Catt Mode power setting, Verify that each of the other modes can be selected and adjusted up and down in the same manner as the Pure Cut Mode described above, ‘The other modes include: Blend 1 Blend 2 Blend 3 Pinpoint Coag Standard Coag Spray Coag Bipotar Rerun all se tings to the desited setting, Depress the bipolar footswitch, Confirm that the Bipolar Mode indicator illuminates and a bipolar activation tone is souncied. While continuing to depress the bipolar footswitch, rotate the Volume Control over its full range to verify the famction of that control and that sound is audible at all positions. ‘This control ‘may be left at any desired position, Release lac footswitch and confirm the System returns to its idle state. Set the bipolar power setting to 1 watt and verify the bipolar hhand control is functional by use of the appropriate forceps or by connecting a jumper between the center and right hand Bipolar Output receptacle on the Output Panel. The effect will be identical to depressing the bipolar footswitch, EE | 3 LL. Verify that the Single and Dual Dispersive Electrode Status / Alarm Indicators alternately fash red, Connect a single dispersive electrode to the Dispersive Electrode Receptacle. Confirm the Single Dispersive Electrode Status / Alarm Indicator is steady green, 12, Depress the Cut treadle of the Monopolar footswitch. ‘The yellow Cut Mode indicator should light and the cut activation tone shoul sound, 18. While continuing to press the Cut treadle of the footswitch, press the Cong treadle. The yellow Cut Mode indicator should remain should continue, Release the Cut treadle while continuing to press the Coag rreadle and confirm that an Ace ertor appeats on the display. Release the coag treadle and verify that the display returns t0 normal, Press the Coag rreadle and verify that the blue Coag Mode indicator illuminates until the Coag tread is released. 14, Connect a hand-controlled accessory to one of the Monopolar Accessory Receptacles. Activate the Cut and Coag buttons on the accessory, one ata time, verifying that each control causes the correct indicator and tone to sound. Move the hand-controlled accessory to the other Monopolar Accessory Receptacle and repeat. 15. Disconnect the single dispersive electrode and confirm that the System 2500" beeps three times and the Single and Dual Dispersive Electrode Status / Alarm Indicators alternately flash red, 2.8.2 Preliminary Performance Testing, After the ESU passes the Preliminary Functional ‘Tests of Section 2.3.1, preliminary performance testing may be conducted. Such testing is best carried out by use of an electrosurgical generator tester. Use a non-inductive resistor with the same value as the rated generator output impedance for the best accuracy of the tester. (See Specifications, Section 1.2) IFno tester is convenient, the availability of therapeutic current may be ascertained subjectively by attempting to cut and coagulate on surrogate tissue such as a piece of meat or fies fruit, a wet istened with saline. 2.4 Controls, Displays and Connectors ‘The numbers preceding the following paragraphs correspond to the numbered items in Figures 2.1, 22and 23 2.4.1 Control Panel All controls, except for the volume control, are located on the front control panel. Refer to Figure 21. 1. SINGLE DISPERSIVE ELECTRODE STATUS / ALARM INDICATOR: Indicates the searus ofa single dispersive electrode when the single dispersive electrode is connected ro the ESU, ‘This STATUS INDICATOR will flash red prior to connection of any dispersive electrode. "This STATUS INDICATOR witl illuminate steady green after a single dispersive electrode is acceptably connected to the ESU. WARNING ‘THE SINGLE DISPERSIVE ELECTRODE STATUS / ALARM INDICATOR DOES NOT PROVIDE ANY INDICATION OF THE CONTACT QUALITY BETWEEN THE SINGLE DISPERSIVE ELECTRODE AND THE PATIENT. If the quality of connection between the ESU andl the single dispersive eleciroxte deteriorates toa level that is unacceptable, this STATUS INDICATOR will flash red and an alarm will sound. 2, DUAL DISPERSIVE ELECTRODE, STATUS / ALARM INDICATOR: Indicates the status of dual dispersive electrocle when the dual dispersive electrode is connected to the ESU. ‘This indicator is made up of a STATUS INDICATOR and a BARGRAPH, which indicates the relative quality of the du dispersive electrode application. ‘The STATUS INDICATOR will flash ree prior to connection of any dispersive electrode or connection of a dual dispersive electrode that is not applied to the patient. "This indicator will flash green after a dual dispersive electrode is applied to the patient and the contact quality of the dual dispersive electrode is at an acceptable level. ‘The status indicator ‘will illuminate steady green upon fitst activation using a hand control or footswitch 7 2 with a dual dispersive electrode that is installed and connected with acceptable contact quality Prior to activation, the BARGRAPH will show a relative measure of the contact quality between the wo elements of the du dispersive electrode. Good contact quality is indicated by illumination of many segments, ‘while poor contact quality will illuminate fewer segments. Acceptable contact quality to enable safe use of the SU will be indicated by illumination of one or more segments. All of the BARGRAPH segments will be illuminated ‘upon activation with an acceptably installed and connected dispersive electrode. Fewer segments of the bar graph will be illuminated as the contact quality ofthe dispersive clectrode deteriorates; asa result, the Dual Dispersive Electrode Status / Alarm Indicator gives a relative measure of contact quality as the procedure progresses. Ifthe contact quality deteriorates to a level that is unacceptable, all BARGRAPIT segments will be extinguished, the STATUS INDICATOR will lash red and an alarm will sound, MONOPOLAR CUT POWER DIGITAL DISPLAY: Indicates the power setting for the currently selected monopolar cut mode MONOPOLAR CUT MODE INDICATOR: ‘This yellow indicator lights when the ESU is activated in a monopolar cut mode. MONOPOLAR CUT POWER ADJUSTMENT KEYS: Adjusts the output power setting of the selected cut mode, PURE CUT SELECT KEY: Pressing this key will select monopolar PURE cut. PURE CUT MODE INDICATOR: Iihumninates witen monopolar PURE cut has been selected. BLEND 1 SELECT KEY: Pressing this key vill seleet monopolar BLEND I. BLEND 1 INDICATOR; Iluminates when monopolae BLEND 1 is selected BLEND 2 SELECT KEY: Pressing this key will select monopokir BLEND 2. BLEND 2 INDICATOR: Iluminates when monopolar BLEND 2 is selected. BLEND 3 SELECT KEY: Pressing this key ‘will select monopolar BLEND 3. BLEND 3 INDICATOR: Illuminates when monopolar BLEND 3 is selected. Figure 2.1 Control Panel | 2 10, MONOPOLAR COAG POWER DIGITAL DISPLAY: Indicates the power setting in the currently selected monopolar coagulation mode. 11, MONOPOLAR COAG MODE INDICATOR: This blue indicator lights when the ESU is activated in a monopolar coagulation mode 12, MONOPOLAR COAG POWER ADJUSTMENT KEYS; Adjusts the output power setting of the selected coagulation mode. 13. PINPOINT COAG SELECT KE! Pressing this key will select monopolar PINPOINT coagulation. PINPOINT COAG INDICATOR: Illuminates when monopolar PINPOINT coagulation has been selected, 14, STANDARD COAG OP KEY: Pressing this key will select monopolar STANDARD. coagulation, STANDARD COAG INDICATOR: Illuminates when monopolar STANDARD coagulation has been selected. 15, SPRAY COAG SELECT KEY: Pressing this key will select monopolar SPRAY coagulation. SPRAY COAG INDICATOR: Illuminates when monopolar SPRAY coagulation has been selected. 16, BIPOLAR POWER DIGITAL DISPLAY: Indicates the bipolar power level set via the Bipolar Power Adjustment Keys in the Bipolar mode, 20. IWO-PIN DISPERSE ELECTRODE RECEPTACLE 206) flor 00 17, BIPOLAR MODE INDICATOR: This indicator lighs when the ESU is activated in the bipolar mode, 18, BIPOLAR POWER ADJUSTMENT KEYS Adjasts the output power level of the Bipolar mode, 19, REMOTE POWER CONTROL KEY: Pressing this key wil select or deselect Remote Power Control. REMOTE POWER ‘CONTROL INDICATOR: Illumninates when Remote Power Control is selected 2.4.2 Output Panel “The ouxpur panel contains the power switch and the accessory receptacles. Refer to Figure 2.2. 20. DISPERSIVE ELECTROL RECEPTACLE: This receptacle accepts a standard two-pin single or dual dispersive electrode ping, ReadiPlug™ UNIVERSAL ACCESSORY RECEPTACLE: This receptacle accepts accessory’ cables equipped with standard active (Bovie #12) plugs, standard 4mm banana plugs or pin-tip style disposable connectors ‘without the necessity of special adapters. Banana plugs ean be inserted and removed directly without any other action. ‘To insert a Bovie #12 plug or a pin-tip style plug, simply rush the button adjacent to the receptacle, {nsert the plug filly and release the button. To remove, press the button and pull the plug out. ‘This receptacle can only be activated by tie monopolar footswitch, WARNING: NEVER CONNECT MORE THAN ONE ACCESSORY AT ATIME TO THIS RECEPTACLE. aL 22, HAND CONTROLLED MONOPOLAR POWE! ACCESSORY RECEPTACLES eee > oof 0° o il Un. RoadiPlug" UNIVERSAL ‘ACCESSORY RECEPTACLE 23, BIPOLAR ACCESSORY RECEPTACLE Figure 2.2. Output Panel eS $51 5 22, HAND-CONTROLLED MONOPOLAR ACCESSORY RECEPTACLE: ‘Two independent receptacles are provided for the connection of hand-controlled monopolar accessories. Only by the accessories comnected to them may activate these receptacles, 23, BIPOLAR ACCESSORY RECEPTACLE: Bipolar output is activated by the bipolar foot-controlled or by hand-controlled bipolar accessories, CONMED a fixed connection style plugs ave recommended! for this receptacle, For legacy connections with two banana plug leads, connect these active bipolar Forceps leads to the outside connections. POWER SWITCH: Primary power switeh for turning the ESU on and oft 24 2.4.3 Rear Panel “The rear panel contains the footswitch connectors, power cord connector, fuses, volume control and a carrying handle. Refer to Figure 2.3, 25. CARRYING HANDL 26, SPEAKER: Sound from the speaker emanates fiom this location, 27. NAMEPLATE: Specifies model number, serial ‘number, nominal line voltages, frequency ‘current and fase rating information. 28. FAN: Forced ar from the temperature controlled fan is expelled in this location. 29, BIPOLAR FOOTSWITCH CONNECTOR: ‘A pin threaded connector designed to accept any CONMED Electeostrgery single-treadle bipolar footswitch, 30, MONOPOLAR FOOTSWITCH CONNECTOR: This 4-pin threaded ‘connector is designed to accept plugs attached to any dual treadle monopolat footswitch available from CONMED Electrosurgery. Use only CONMED Electrasurgery footswitches. ‘Other manufactarer’s fooiswitches may not be compatible, 31. ACTIVATION RELAY CONNECTOR: A. receptacle for actuating smoke evacuators and ilar devices when delivering electrosurgical je a & = Sm — Figure 2.3 Rear Panel ms |? «3: 2 coutput, The masinnum contact rating for this recepracle is | amp at 24 volts DC, Verify that devices connected to this output function properly in a manner that is synchronized with ESU power delivery prior to use 32. EQUIPOTENTIAL GROUND CONNECTION: Chassis ground connection suitable for attachment of standard susiliary grounding cable when required for additional protection against low frequency risk current 33, FUSE RECEPTACLES: For installation ‘of nwo mains fuses with ratings as noted in Section 2.2.1 34, POWER INLEE Supplies AC mains power to the ESU. It should only be connected to a source of power corresponding to that listed ‘on the nameplate, 35. VOLUME CONTROL: Contiols the volume ofthe tones produced during normal activation of the ESU, Rotation to the right increases the volume. It does not affect the volume of alarm tones 2.8 Set Up For Use 1, Ensure the Power Switch is OFK, and then connect the power cable to a properly ‘grounded and polseized mating power receptacle. Do not connect a disper electrode at this time 2. Inspect and connect the desired monopolar or bipolar aecessories to the connectors on the front of the ESU, Refer to Fignre 2.2 WARNING ALWAYS STOW UNUSED ACCESSORIES IN A SARE, INSULATED LOCATION SUCH AS A HOLSTER. DO NOT PLACE ACTIVE ACCESSORIES ON THE PATIENT. 3. Connect the footswitches, as required, to the rear of the FSU (not required if only hand- contiolled accessories are to be used). Use only CONMED Electrosurgery footswitches. 4, Set the Power Switch to the ON position ‘As the ESU goes through its internal sel diagnostics, confirm the machine responds by: a) Sounding a test tone. b) During the test tone, displaying a total of eight “8's on the thee digital displays ©) _Tuminating all ree mode indicators, all eight key indicators, wwo dispersive lectrode indicators and the entire dal dispersive cleetrode contact quality BARGRAPH. dd) Afier the display test, the ESU will show the software revision level in the COAG display window, The ESU is conducting a power-on selftest during this interval, After the power-on selFtests, the ESU is ready foruse. Ifthe ESU sounds a pulsating high tone, displays an “Ere” fault code or otherwise fails to respond as above, the ESU has failed one of its internal tests and is not suitable for tise. Before turning the power off, note the “Er code displayed in the Power Displays: to assist in the diagnosis by a qualified biomedical engincer. “Acc” codes can often be corrected by operating room staff, see Section 2.7.2. Contact your qualified biomedica ‘engineer for repair if an “Err” code appears. When using monopolar modes, select and prepare the patient dispersive electtode site and apply the dispersive electrode in fall contact with the patient and in accordance ‘with the manufacturers instructions. If no instruetions are given, observe the guidelines provided in Seetion 1.0 of this manual. A persive electrode need not be connecte‘ only BIPOLAR operation is required. CAUTION: The use and proper placement ofa dispersive electrode is a key element in safe and effective electrosurgety. Follow manufacturet’s directions and recommend- ‘ed practices for the preparation, placement, use, surveillance and removal of any dis- persive clectrode supplied for use with this electrosurgical unit. Apply the dispersive electrode over a welk-vas- calarized muscle mass that is thoroughly clean and dry: Clean and shave site, as necessary, to provide adequate electrical connection and per hospital policy. Avoid placement over se tissue, bony prominences or other areas where presstire points on small areas might develop. 2 37 2 I, 7. Inspect and conneet the plug of the dispersive clectrode cable to the Dispersive Electrode ‘Receptacle or to an appropriate adapter. NOTE: This ESU incorporates A.R.M. circuitry. The monitor will inhibit monopolar operation of the FSU if ts requirements for the dispersive electrode have not been satisfied {see instruction 8). 8, ‘The A.R.M. dispersive electrode contact ‘quality monitor can automatically detect and accept either single dispersive electrexies or dlual dispersive electrodes ‘The Single Dispersive Electrode Status / Aloem Indicator indicates the status of a single dispersive electrode when the single dispersive electrode is connected to the ESU. This STATUS INDICATOR will flash red prior to connection of any dispersive electrode, This STATUS INDICATOR will illuminate steady green after a single dispersive electrode is acceptably connected to the ESU. The Single Dispersive Electrode Status / Alatm Indicator DOES NOT provide any indication of the ‘contact quality between the single dispersive electrode and the patien Afthe connection between the ESU and the e electrode is broken, the Single \ill lash red and an alarm will sound. The DUAL DISPERSIVE ELECTRODE STATUS / ALARM INDICATOR indicates the status of a dual dispersive electrode when the dual dispersive electrode is connected to the FSU. ‘This indicator is made up of a BARGRAPH,, which indicates the relative gual application and a STATUS INDICATOR. The STATUS INDICATOR will lash red prior to connection of any dispersive electrode br connection ofa eal dispersive less that is not applied to the patient. This STATUS INDICATOR will flash green after a dual dispersive electrode is applied and the measured impedance between the dual dispersive electrodes is at an acceptable level. ‘The STATUS INDICATOR will illuminate steady green upon first activation using a hand control or footswitch with a dual dispersive clectrode that is installed and connected with acceptable contact quality Prior to activation, the BARGRAPH will show a relative measure of the contact ality between the two clements of the dual ipersive electrode. Good contact quality indicated by illumination of many segments, while poor eontact quality will illaminate fewer segments. Acceptable contact quality to enable safe use of the PSU will be indicated lumination of one or more segments. the BARGRAPH segments will be ninated upon activation with an acceptably installed and connected dispersive electrode. Fewer segments of the BARGRAPH will be illuminated as the contact quality of the dispersive clectrode deteriorates; as a result, the Dual Dispersive Electrode Status / Alarm Indicator gives a relative measure of contact quulity as the procedate progresses, Ifthe contact quality deteriorates to a level that is unacceptable, all BARGRAPH segments will be extinguished, the Daal Dispersive Electrode Status / Alarm Indicator will flash red and an alarm will sound. When alarm occurs, physically confirm proper dispersive electrode-to-patient contact. Smooth the dispersive electrode surface with hand to improve electrode contact to ant’s skin, Green bargraph segments will wicate improved patient contact. Replace the dispersive electrode if dispersive electrode statusfalarm indicator continues to flash red, WARNING DO NOT DEPEND SOLELY ON THE DUAL DISPERSIVE ELECTRODE STATUS / ALARM INDICATOR FOR CONFIRMATION OF GOOD DISPERSIVE 10. i. ELECTRODE APPLICATION. QUALIFIED PERSONNEL SHOULD MAKE THB FINAL DECISION ON PROPER DISPERSIVE ELECTRODE, PLACEMENT, ‘The ESU powers up to the lat settings at the time the ESU was last activated, Note: Power up to “0” setting is a configuration option that may be selected by a qualified biomed ‘engineer, Verify that the ESU is properly adjusted with the desired mode selected. Adjust the settings as needed. The ESU is now ready for operation, Set the Monopolar Cut Mode to Pure for cutting or one of three Blend! modes for desired cutting with hemostasi Set the Monopolar Coag Mode to PINPOINT to provide soft /Jow voltage contact coagulation, to STANDARD to provide a a | 2 greater degree of contact desiccation (i. greater arcing) or to SPRAY for non-contact fulgucation. 12, Adjust the CUT, COAG, and BIPOLAR power to the desired levels in the following manner: ~T inerement or decrement the power ‘one step, momentarily press and release the desired CUT, COAG, or BIPOLAR Power Adjustment Kes: The power will increase one step and a short tone will sound, = Tp increase or decrease the power 3 number of steps, press and hold the desired CUT, COAG, or BIPOLAR Power Adjustment Key. For the first nine steps while the key is held, the power will increase or decrease in step increments with a short tone for each step. If the key is continuously held after the ninth step, power will increase or decrease at an accelerated rate, with a continuous tone, until the Power Adjustment Key is released. IF unsure of the proper settings, use ow power settings intially and make adjustments intraoperatively according to the surgeon's requests, Use of a written record of each surgeon's preferred power setting for various procedures will expedite subsequent pre-op setup. 2.6 Operation WARNING: ENSURE THAT THE ROOTSWITCHES ARE NOT INADVERTENTLY DEPRESSED IN ORDER TO PREVENT ACCESSORIES FROM BEING UNINTENTIONALLY ACTIVATED, PLACE FOOTSWITCHES IN LOCATIONS THAT NECESSITATE, DELIBERATE ACTION IN ORDER TO ACTIVATE THE FOOTSWITCH, USE CAUTION WHEN SELECTING THE CORRECT FOOTSWITCH TO ACTIVATE. he cecrosgial uni inthe desied mode by depressing the appropriate the Footsie or atch oa and controled acceso, Acjun the comespanding power sting ntl theese! saga effects ae Power setting changes are limited when the ESU is activated 16 the greater of 10 watts oF 25% of te dal setting upon inition of atvation, The wer setting will be displayed on the digital {splay for each mode. ‘The surgical effects obtained are dependent on a number Of factors including waveform, electrode size, electrode geometry, power level and surgical technique. ‘The size and geometry of monopolar electrodes ate significant in that a large clectroce, absent of shar p atures (eg: 3ball else) will have no tendency to cut, regardless of the output power level Conversely s small sharp eketrode, Such as aneedie or wire loop, will be fikely to cut simply from mechanical pressure at conservative power settings. Note that ather generator models, $l have cifferent clinical effets than the System 2500", even when the power settings are the ‘The Bipolar Coagulation waveform is designed to sninimize tse sticking al popp' " the ourpr voltage regal ofthe poser set, Bipolat hemostasis is more localized than in monopolar since the tissue grasped between the forceps tines is most affected. This is particularly desirable in vascular surgery where monopolar current may concentrate in the affected vessel and result in undesired tissue effects. This easily controlled localization is also of benefit in plastic surgery and neurosurgery 2.6.1 Remote Power Control Remote Power Control provides the surgeon swith the ability to change power settings from the surgical field using the activation switches on the ‘monopolar accessory CAUTION: The Remote Power Control feature should be enabled only if the surgeon is familiar with its operation and requires its capabilities, The power displays should be monitored for expected effect while Remote Power Control adjustments are heing pesformed until normal operation is restored. “The Remote Power Control may only be activated avhen the Remote Power Control Indicator is on, ‘This mode may be selected or deselected with the Remote Power Control Key. Remote Power Control will always be disabled after power up. 2.6.11 Changing Monopolar Power Remotely 1. Select Remote Power Control by pressing the Remote Power Control Key. 2. Double click the CUT button on the accessory to adjust the cut power or double click the COAG button to adjust the coagulation power 3. Aloud acceptance tone will sound, allowing power adjustments only from the accessory’ where the double click was detected, 4, Only the Power Indicator for the associated power adjustment selected will be illuminated. 5, Only the Remote Power Control Key on the front panel will be functional | 57 2 Ie 6. Depress CUT on the accessory to inerease power or depress COAG to decrease power. An audible tone will sound for each power increment change, 7. Ashore up or down tone will sound with each fone-watt step. 8. As the ent or eoag buttons on the accessory are held down for more than nine one-wate steps, the power adjustment will be accelerated and a continuous tone will sound, Releasing the switch and then pressing once again will start the single step function, 9, ‘To end Remote Power Control: 8) Double click either CUT or COAG. -OR- b) Turn off Remote Power Control Mode. -OR- ©) Do not press CUT or COAG buttons for 3 seconds and the fiction will time out. 10. A loud acceptance tone will sound, returning control for normal operation, 2.7 User Maintenance 2.7.1 General Maintenance Information ‘While the System 2500” has been designed and manuufactared to high industry standards, icis recommended that periodic inspection and pevformance testing be performed by a qualified biomedical engineer using techniques described in. the appropriate sections of this manval to ensure continued safe and elfective operation. 2.7.2 Cleaning ‘The exterior of the ESU may be cleaned by \wiping it with a cloth that as been dampened (not dripping) with a mild detergent or mild

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