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60-8016-ENG REV N.indd - Frank`s Hospital Workshop

1. sese ees 1 18 Figure 1 10 Load Regulation Bipolar Micro esses enema 1 18 Figure 1 11 Load Regulation Bipolar Macro sese ee eene 1 19 Figure 1 12 Load Regulation Lap Spray iioc ceret eph orae en eee b aue haad 1 19 Bigure 1 13 Load Regulation Lap Standard i iiie eet terere tere Re RR HERREN DUE 1 20 HBigure2 l Control Panel iie etre rettet terre e EE ERREUR aan ER ERE EN Ra Fee ERR R M ERR M dee 2 4 Figure 2 2 Output Panel oit tst te pte n ta tice nega TH a SIR a Era Co ut Pepe staaee 2 6 Figure 2 9 Rear Panel icd oe tiep re ee md di EO IR D OO e RENT Ren ndn a 2 7 Biguie 2 4 Accessory Schematics ronas aE etu eti eie Eder AIR EMI ea S 2 14 Fip re 2 5 Accessory Connections c erii pe tier PAIRE ERI E PH aU MINER De ER VERE EUR HL UR ND EACH I ORBE NERA RS UR ai 2 14 SYST 25000 General Information Section 1 0 This manual provides the set up and operating instructions for the System 5000 Electrosurgical Unit ESU Electrosurgery can be dangerous to patients staff and other equipment if mis used Please understand and follow the warnings and cautions that are included in this manual Technical specifications performance characteristic curves and user maintenance instructions are also included The System 5000 provides a broad range of capabilities in a single general purpose electrosurgical generator This rugged ESU fulfills the operational and safet
2. d 500 1000 1500 2000 Load Resistance Ohms Figure 1 4 Load Regulation Monopolar Blend 1 1 15 S 757 A7 5000 250 0 200 200 0 E 150 0 jaw amp 100 0 a 50 0 0 0 0 500 1000 1500 2000 Load Resistance Ohms Figure 1 5 Load Regulation Monopolar Blend 2 250 0 200 0 E 150 0 jaw amp 100 0 e 50 0 0 0 500 1000 1500 2000 Load Resistance Ohms Figure 1 6 Load Regulation Monopolar Blend 3 1 16 Output Power Watts Output Power Watts 140 0 120 0 100 0 80 0 60 0 40 0 20 0 0 0 140 0 120 0 100 0 80 0 60 0 40 0 20 0 0 0 SYSTEM 5000 0 500 1000 1500 2000 Load Resistance Ohms Figure 1 7 Load Regulation Monopolar Pinpoint Coag 500 1000 1500 2000 Load Resistance Ohms Figure 1 8 Load Regulation Monopolar Standard Coag 1 17 SYSTEM 5000 90 0 80 0 70 0 60 0 50 0 40 0 30 0 Output Power Watts 20 0 10 0 0 0 0 500 1000 1500 2000 Load Resistance Ohms Figure 1 9 Load Regulation Monopolar Spray Coag 60 0 40 0 30 0 20 0 Output Power Watts 10 0 0 0 1 i 200 400 600 800 1000 eo Load Resistance Ohms Figure 1 10 Load Regulation Bipolar Micro 1 18 N 5000 90 100 0 90 0 80 0
3. 10 An acceptance tone will sound returning control for normal operation 2 7 User Maintenance 2 7 1 General Maintenance Information While the System 5000 has been designed and manufactured to high industry standards it is recommended that periodic inspection and performance testing be performed by a Hospital Qualified Biomedical Technician using techniques described in the ConMed System 5000 Service Manual Catalog Number 60 8017 ENG to ensure continued safe and effective operation 2 12 2 7 2 Cleaning The exterior of the ESU may be cleaned by wip ing it with a cloth that has been dampened not dripping with a mild detergent or mild disinfect ing solution 2 7 3 Periodic Inspection The System 5000 should be visually inspected at least every year This inspection should include checks for Damage to the power cord Damage to the power plug Tightness of the power plug Tightness of the volume control knob Proper mating cleanliness and absence of damage to the patient connectors Obvious external or internal damage to the ESU Accumulation of lint or debris within the ESU or heatsink 2 7 4 Periodic Performance Testing The System 5000 should be performance tested by a Hospital Qualified Biomedical Technician at least every year Each ESU is supplied with a seri alized Product Test Data Sheet which tabulates the results of the factory tests performed on the ESU This da
4. a 5557607 5000 fewer segments Acceptable contact quality to enable safe use of the ESU will be indicated by illumination of one or more segments All of the BARGRAPH segments will be illu minated 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 electrode deteriorates as a result the Dual Dispersive Electrode Status Alarm Indicator gives a relative measure of contact quality as the procedure progresses If the contact quality deteriorates to a level that is unacceptable all BARGRAPH segments will be extinguished the Dual 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 patient s skin Green bar graph segments will indicate improved patient contact Replace the dis persive electrode if dispersive electrode status alarm indicator continues to flash red WARNING DO NOT DEPEND SOLELY ON THE DUAL DISPERSIVE ELECTRODE STATUS ALARM INDICATOR FOR CONFIRMATION OF GOOD DISPERSIVE ELECTRODE APPLICATION QUALIFIED PERSONNEL SHOULD MAKE THE FINAL DECISION ON PROPER DISPERSIVE ELECTRODE PLACEMENT 9 The ESU powers up to the last settings at the time the ESU was last activated Note Power up to 0
5. setting is a configuration option that may be selected by a Hospital Qualified Biomedical Technician Verify that the ESU is properly adjusted with the desired mode selected Adjust the settings as needed The ESU is now ready for operation 10 Scroll to the LAP Specialty Mode to limit output voltage during Laparoscopic proce dures 11 Scroll to the FLUIDS Specialty Mode to initiate cutting and coagulating during proce dures conducted in fluid mediums 12 Set the Monopolar Cut Mode to Pure for cutting or one of three Blend modes for desired cutting with hemostasis 13 Set the Monopolar Coag Mode to PINPOINT to provide soft low voltage con tact coagulation to STANDARD to provide a greater degree of contact desiccation 1 e greater arcing or to SPRAY for non contact fulguration 14 Scroll to BIPOLAR MACRO for nor mal bipolar tissue desiccation or scroll to BIPOLAR MICRO for delicate bipolar tissue desiccation with low voltage 15 The Bipolar Output Meter provides a mea sure of tissue desiccation between the bipolar forceps tines by measuring tissue resistance Higher tissue resistances indicate a greater degree of desiccation Several illuminated segments indicates low desiccation while fewer illuminated segments indicates higher desiccation Few segments will be illumi nated when bipolar power is first applied because the resistance of the tissue is high As bipolar power continues inter cellular fluid is rele
6. 70 0 60 0 50 0 40 0 Output Power Watts 30 0 20 0 10 0 0 0 0 200 400 600 800 1000 Load Resistance Ohms Figure 1 11 Load Regulation Bipolar Macro 90 0 mL ZN wo _ N 80 60 0 50 0 40 0 0 Output Power Watts 500 1000 1500 2000 Load Resistance Ohms Figure 1 12 Load Regulation Lap Spray 1 19 S 757 A7 5000 140 0 120 0 100 0 80 0 60 0 Output Power Watts 40 0 20 0 0 0 500 1000 1500 2000 Load Resistance Ohms Figure 1 13 Load Regulation Lap Standard 1 20 SYST 5000 Installation and Operation Section 2 0 This section contains initial installation prelimi nary checks and operating instructions for the System 5000 2 1 Initial Inspection Unpack the ESU upon receipt and physically inspect it for any obvious damage that may have occurred during shipment A Hospital Qualified Biomedical Technician should perform this inspec tion Notify the carrier and your CONMED rep resentative immediately if damage is found 2 2 Installation The ESU may be mounted on a matching mobile pedestal or any stable mobile pedestal or table 2 2 1 Installation Of Fuses Outside of the U S proper fuses must be installed prior to connection to any power source Install fuses in the following manner a Ensure the power cord is disconnected from the ESU b Locate
7. INDICATOR This blue indicator lights when the ESU is activated in a monopolar coagulation mode 26 COAG SCROLL KEY Pressing this key will scroll through the Coag Modes Pinpoint Standard and Spray 27 MONOPOLAR COAG POWER ADJUSTMENT KEYS Adjusts the output power setting of the selected coagulation mode 28 PULSE COAG KEY Pressing this key will select or deselect Pulse Coag 29 MICRO BIPOLAR INDICATOR Illuminates when micro bipolar is selected 30 MACRO BIPOLAR INDICATOR Illuminates when Macro Bipolar is selected 31 BIPOLAR ACIIVATION INDICATOR This indicator lights when the ESU is activated in the bipolar mode 32 BIPOLAR OUTPUT METER This bar graph display provides a measure of the tissue resistance 33 BIPOLAR POWER DIGITAL DISPLAY Indicates the bipolar mode power level set via the Bipolar Power Adjustment Keys 34 BIPOLAR SCROLL KEY Pressing this key will scroll through the Bipolar Modes Macro and Micro 35 BIPOLAR POWER ADJUSTMENT KEYS Adjusts the output power level of the selected bipolar mode 36 REMOTE POWER CONTROL KEY Pressing this key will select or deselect Remote Power Control REMOTE POWER CONTROL INDICATOR Illuminates when Remote Power Control is selected 2 4 20 Output Panel The output panel contains the power switch and the accessory receptacles The receptacles are illu minated to aid in the insertion of the connectors in low light conditions Refer to Figure 2
8. Operator s Manual Manual S S IEAI 50707 ELECT ROS UR GICAL UNIT LIMITED WARRANTY For a period of two years following the date of delivery CONMED Corporation warrants the CONMED System 5000 Electrosurgical Generator against any defects in material or workmanship and will repair or replace at CONMED s option the same without charge provided that routine maintenance as specified in this manual has been performed using replacement parts approved by CONMED This warranty is void if the product is used in a manner or for purposes other than intended 2007 CONMED Corporation 525 French Road Utica New York 13502 U S A U S Patent Nos 4 961 739 5 152 762 5 626 575 6 830 569 6 835 082 6 875 210 6 939 347 D477 082 D477 408 For Technical Service or Return Authorization Phone 303 699 7600 1 800 552 0138 Extension 5274 Fax 303 699 1628 For Customer Service or to order parts phone 1 800 448 6506 315 797 8375 Fax 315 735 6235 or contact your CONMED Representative European Authorized Representative MDSS GmbH Schiffgraben 41 D 30175 Hannover Germany The revision level of this manual is specified by the highest revision letter found on either the inside front cover or enclosed errata pages if any Manual Number 60 8016 ENG Rev N 11 07 Unit Serial Number Section 1 0 1 1 1 1 1 1 1 2 1 1 3 1 1 4 1 1 5 1 1 5 1 1 1 5 2 1 1 5 3 1 1 5 4 1 2 1 2 1 1 2 2 1 2 3 1 2 4
9. are suitable for the intended procedure The output power selected should be as low as possible and activation times should be as short as possible for the intended purpose The clinical use of electrosurgery is intermit tent in nature This ESU should not be acti vated continuously for extended periods of time When uncertain of the proper setting for the power level in a given procedure start with a low setting and increase as required Confirm that Pulse Cut Mode is properly selected prior to activation to ensure that improper application does not result in patient injury Set the monopolar coag power to 0 when using Pulse Cut to ensure that an accidental activation of coag does not cause patient injury Listen for the distinct Pulse Cut Activation Tone during activation to con firm that Pulse Cut is indeed active Observe all caution and warning symbols printed on the ESU The operating room staff should never contact electrosurgical electrodes either active or dis persive while the RF output of the ESU is energized The electrodes of recently activated accesso ries may be hot enough to burn the patient or ignite surgical drapes or other flammable material Do not ignore unexpected tones Check to determine the cause of the tone otherwise injury can occur Temporarily unused active electrodes should be stored in an electrically insulated holster The unused active electrode should never b
10. 2 37 DISPERSIVE ELECTRODE RECEPTACLE This receptacle accepts a standard two pin single or dual dispersive electrode plug 38 ReadiPlug UNIVERSAL ACCESSORY RECEPTACLE This receptacle accepts acces sory 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 can be inserted and removed directly without pushing the button To insert a Bovie 12 plug you must push the button adjacent to the recep tacle 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 2 5 S 757 A7 5000 37 TWO PIN DISPERSIVE ELECTRODE RECEPTACLE 39 HAND CONTROLLED MONOPOLAR ACCESSORY RECEPTACLES 41 POWER SWITCH 40 BIPOLAR ACCESSORY RECEPTACLE 38 ReadiPlug UNIVERSAL ACCESSORY RECEPTACLE Figure 2 2 Output Panel When handling the pin tip style plug hold 2 4 8 Rear Panel the wire about 3 inches 7 6 cm from the tip and push the button while insert ing the tip IMPORTANT Verify proper insertion by tugging gently on the plug to The rear panel contains the footswitch connectors power cord connector fuses volume controls and a carrying handle Refer to Figure 2 3 42 CARRYING HANDLE ensure that the ReadiPlug mechanism has properly retained the tip To remove the pin tip you must press the button
11. 2VP 80 MHz to 800 MHz 80 MHz to 2 5 GHz d 2 3VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation dis tance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol V NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 1 8 Field strengths from fixed transmitters such as base stations for radio cellular cordless tele phones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the System 5000 Electrosurgical Unit is used exceeds the applicable RF compliance level above the System 5000 Electrosurgical Unit should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the System 5000
12. Alarm indicators flash red in unison the impedance is too low This condition can be caused by a short in the cable a short between the two pads on the dispersive electrode or some fault within the ESU Replace the dispersive electrode while ensuring the dispersive electrode makes con tact only with the patient 2 8 2 Acc Codes Acc Codes are most often caused by faults in accessories connected to the ESU The fault can often be corrected in the operating room with out a service call The following list gives the meaning of each code For each code check the indicated accessory for proper operation If the fault persists unplug the accessory turn the ESU off and then turn the ESU back on If the fault is still present call a Hospital Qualified Biomedical Technician for assistance Acc FS Monopolar Footswitch Shorted Ensure footswitch treadle is not depressed Acc Display Code Meaning and Solution Acc bPF Bipolar Footswitch Shorted Ensure footswitch treadle is not depressed Acc LH Left Hand Monopolar Accessory Shorted Replace hand controlled accessory Acc rH Right Hand Monopolar Accessory Shorted Replace hand controlled accessory Acc bP Bipolar Accessory Shorted Replace bipolar accessory Acc CP Control Panel Key Stuck 2 8 8 Err Codes Err Codes generally cannot be corrected in the operating room and require the assistance of a Hospital Qualified Biomedical Technician Occasionally turning the ESU off and back
13. Electrosurgical Unit Over the frequency range 150 kHz to 80 MHz field strengths should be less than v1 V m N 5557607 5000 1 1 5 4 EN IEC 60601 1 2 Table 206 Recommended separation distances between portable and mobile RF communications equipment and the System 5000 Electrosurgical Unit The System 5000 Electrosurgical Unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the System 5000 Electrosurgical Unit can help prevent elec tromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equip ment transmitters and the System 5000 Electrosurgical Unit as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance according to frequency of transmitter power of transmitter m For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects
14. Loss of power supply isolation can cause elec trical shock When servicing the high voltage power supply assume internal isolation is compromised until verified otherwise Following are guidance and manufacturer s declarations regarding electromagnetic compatibility for the System 5000 1 1 5 1 EN IEC 60601 1 2 Table 201 Guidance and Manufacturer s Declaration Electromagnetic Emissions The System 5000 Electrosurgical Unit is intended for use in the electromagnetic environment specified below The customer or the end user of the System 5000 Electrosurgical Unit should assure that it is used in such an environment Electromagnetic environment guidance RF emissions Group 2 The System 5000 Electrosurgical Unit must emit electromagnetic CISPR 11 energy in order to perform its intended function Nearby elec tronic equipment may be affected RF emissions Class A The System 5000 Electrosurgical Unit is suitable for use in all CISPR 11 establishments other than domestic establishments and those imore endon Class dk directly connected to the public low voltage power supply net IEC 61000 3 2 work that supplies buildings used for domestic purposes Voltage fluctuations Flicker emissions IEC 61000 3 3 N 5557617 5000 1 1 5 2 EN IEC 60601 1 2 Table 202 Guidance and Manufacturer s Declaration Electromagnetic Immunity The System 5000 Electrosurgical Unit is intended for use in the electromagnetic environment specified belo
15. Set the bipolar power setting to 1 watt and verify the bipolar hand control is func E 5000 tional 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 12 Verify that the Single and Dual Dispersive Electrode Status Alarm Indicators alternately flash red Connect a single dispersive elec trode to the Dispersive Electrode Receptacle Confirm the Single Dispersive Electrode Status Alarm Indicator is steady green 13 Depress the Cut treadle of the Monopolar footswitch The yellow Cut Activation indica tor should light and the cut activation tone should sound 14 While continuing to press the Cut treadle of the footswitch press the Coag treadle The yellow Cut Activation indicator should remain illuminated and the Cut activation tones should continue Release the Cut treadle while continuing to press the Coag treadle and confirm that the yellow Cut Activation indicator extinguishes the blue Coag Activation indicator illuminates and the activation tone changes from Cut to Coag Release the coag treadle and verify that the display returns to normal Press the Coag treadle and verify that the blue Coag Activation indicator illuminates until the Coag treadle is released 15 Connect a hand controlled accessory to one of the Monopolar Accessory Receptacles Activate the Cut a
16. activation in Pulse Cut as described in Section 1 2 9 The power displayed on the dial is the power output during the pulses While the pulsed nature makes the average power low the power during pulses can be quite high WARNING COAG ACTIVATIONS WILL NOT BE PULSED WITH PULSE CUT SELECTED SET THE MONOPOLAR COAG POWER TO 0 WHEN USING PULSE CUT TO ENSURE THAT AN ACCIDENTAL ACTI VATION OF COAG DOES NOT CAUSE PATIENT INJURY WARNING CONFIRM THAT THE PULSE CUT MODE IS PROPERLY SELECTED PRIOR TO ACTIVATION TO ENSURE THAT IMPROPER APPLICATION DOES NOT a 5000 RESULT IN PATIENT INJURY LISTEN FOR THE DISTINCT PULSE CUT ACTIVATION TONE DURING ACTIVA TION TO CONFIRM PULSE CUT IS INDEED ACTIVE 2 6 8 Monopolar Pulse Coag Monopolar Pulse Coag provides pulsing bursts of coagulation energy for precise hemostasis in STANDARD or SPRAY modes Average power will be displayed as half of peak power for this selection Coagulation energy is pulsed on for 2 5 ms every 5 ms providing higher peak power during the on portion with an effective lower average power resulting in reduced carbonization Verify the Pulse Coag indicator is illuminated prior to activation to ensure the proper setting Listen for the distinct Pulse Coag Activation tone during activation to confirm Pulse Coag is indeed active 2 6 4 Fluids Specialty Mode FLUIDS Specialty Mode provides rapid initiation of clinical effect for surgical procedures con
17. by CONMED should be connected to this interface Contact your CONMED Sales Representative or CONMED Customer Service at the num bers listed on the inside front cover of this manual 53 BIPOLAR VOLUME CONTROL Controls the volume of the special tones pro duced during bipolar electrosurgery Rotation to the right increases the volume Does not affect volume of alarm tones 54 VOLUME CONTROL Controls the vol ume of the 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 5 Set Up For Use 1 Ensure the Power Switch is OF and then connect the power cable to a properly grounded and polarized mating power recep tacle Do not connect a dispersive electrode at this time 2 Inspect and connect the desired monopolar or bipolar accessories to the connectors on the front of the ESU Refer to Figure 2 2 WARNING ALWAYS STOW UNUSED ACCESSORIES IN A SAFE 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 ESU not required if only hand controlled 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 self diag nostics confirm the machine responds by a Sounding a test tone b During the test tone displaying a total of nine 48 s
18. dbA minimum except Alarms which are 65 dbA minimum 1 10 E e 5000 1 2 10 Other Specifications Power Cord All units supplied with an IEC 320 250V 10A 65 C mains inlet connector Power cords can be ordered from CONMED Electrosurgery or obtained from other sources if the following specifications are met MUT USA Any UL CSA SJT or better 250VAC minimum 16AWG 3 Conductor maxi UL817 Canada manufacturer mum length 20 feet 6m Europe Any HAR cord lt HAR gt HO5WE3G1 0 Copper 1 0mm2 minimum cross sectional area IEC60799 manufacturer maximum length 20 feet or 6 0m Weight 21 5 Ib 9 75 Kg Height 5 5 inches 14 cm Width 13 5 inches 35 cm Depth 21 5 inches 48 cm including handle SPECIFICATIONS SUBJECT TO CHANGE WITHOUT NOTICE 1 2 11 Operating Modes and Nominal Output Parameters Typical Max Open Max Pulse Crest Circuit Loaded Repetition Factor Voltage Voltage Freq KHz Peak Peak Monopolar spay Cong 80 500 71 97 ee Te soa iss Bipolar moco 90 300 6 20 oro eo or wa Measured in the open circuit condition Activation of Pulse Cut will make the selected cut mode Pure Cut Blend 1 Blend 2 or Blend 3 active for 70 milliseconds every 600 milliseconds Activation of Pulse Coag will make the selected coag mode either Standard or Spray active for 2 5 mil liseconds every 5 milliseconds Displayed power setting will represent the average power being delive
19. on will clear an Err fault and resume normal opera tion of the ESU 2 8 4 If All Else Fails Contact CONMED Electrosurgery Technical Services at the phone or fax numbers listed on the inside front cover of this manual Please have the model and serial numbers from the rear panel nameplate along with a description of the prob lem including power settings accessories in use and the fault code Ensure no control panel keys are depressed on power up 2 9 Environmental Protection The shipping container and packing material should be retained in the event the ESU must be returned for factory service At the end of the equipment s life it should be disposed of in accor dance with your local regulations Component materials are e Aluminum enclosure and heatsinks The ESU rear handle is aluminum Thermoset printed wiring boards containing miscellaneous electronic components Transformers made of steel and copper Mains cord made of thermoplastic and copper Shipping container is cardboard packing materials are a combination of Urethane foam and Polyethylene film STE 5000 EE LLLLLLLULLILLL A A D x e CUT lt lt COOS e o ee a re coas SINGLE FOIL ELECTRODE DUAL FOIL ELECTRODE B Cc NEUTRAL ELECTRODE CONNECTIONS FTT CUT MONOPOLAR FOOTSWITCH CONNECTIONS C Y e R 3 COAG di iu C J RF B E ITTI MONOPOLAR HAN
20. on each side back and above the ESU for cooling Cooling Natural convection conduction radiation and temperature controlled fan Storage Conditions 40 C to 70 C at altitudes from 60 to 4500 meters above mean sea level when sealed in original poly bag packing material and shipping carton Prior to shipment or storage the ESU should be enclosed and sealed in a polyethylene bag and placed in original carton using original packaging materials RF Leakage 100 mA per IEC60601 2 2 1998 Clause 19 3 101b 1 2 8 Contact Quality Monitor Single dispersive electrode Two wire continuity detector typical trip threshold is 10 ohms Dual dispersive electrode Two wire resistance monitor typical acceptance range 10 to 150 ohms trip thresh old typically 3096 higher than initial activation visual indication of patient resistance changes 1 2 9 Audio Specifications Enter Cut Remote Power Control 440 Hz fol Cut 520 Hz lowed by 574 Hz Coag 440 Hz Enter Coag Remote Power Control 440 Hz Bipolar 440 Hz followed by 515 Hz Acc Fault 847 Hz pulsating Bipolar Output Tone 215 Hz Dispersive Electrode Alarm 847 Hz pulsating Pulse Cut Activation Tone 520 Hz with peri odic short pulses at 481 Hz during output power Err Fault 847 Hz pulsating Increase Power Level 379 Hz Pulse Coag Activation Tone 440 Hz with peri Decrease Power Level 2 343 Hz odic short pulses at 384 Hz pulses All tones are 45
21. on the four digital displays 2 7 d a c Illuminating all three activation indica tors all eight key indicators two disper sive electrode indicators and the entire dual dispersive electrode contact quality BARGRAPH d After the display test the ESU will show the software revision level in the COAG display window The ESU is conducting a power on self test during this interval After the power on self tests the ESU is ready for use If the ESU sounds a pulsating high tone displays an Err fault code or otherwise fails to respond as above the ESU has failed one of its internal tests and is not suitable for use Before turning the power off note the Err code displayed in the Power Displays to assist in the diagnosis by a Hospital Qualified Biomedical Technician ACC codes can often be corrected by operating room staff see Section 2 7 2 Contact your Hospital Qualified Biomedical Technician for repair if an Err code appears When using monopolar modes select and prepare the patient dispersive electrode site and apply the dispersive electrode in full contact with the patient and in accordance with the manufacturer s instructions If no instructions are given observe the guidelines provided in Section 1 0 of this manual A dispersive electrode need not be connected if only BIPOLAR operation is required Caution The use and proper placement of a dispersive electrode is a key element in safe and effe
22. 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 11 5577 EEENNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNI 2 6 7 1 Changing Monopolar Power Remotely 1 Select Remote Power Control by pressing the Remote Power Control Key 2 Double click the CUT button on the acces sory to adjust the cut power or double click the COAG button to adjust the coagulation power 3 An 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 6 Depress CUT on the accessory to increase power or depress COAG to decrease power An audible tone will sound for each power increment change 7 A short up or down tone will sound with each one watt step 8 As the cut or coag buttons on the accessory are held down for more than nine one watt steps the power adjustment will be accel erated 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 a Double click either CUT or COAG OR b Turn off Remote Power Control Mode OR c Do not press CUT or COAG buttons for 3 seconds and the function will time out
23. the fuses that are packaged with the ESU There will be three sets of fuses pro vided 8 0 A for installations with nominal mains voltages of 100 VRMS Part num ber 62 4236 800 6 3 A for installations with nominal mains voltages of 115 VRMS Part num ber 62 4236 630 3 15 A for installation with nominal mains voltages of 230 VRMS or greater Part number 62 4236 315 Choose the correct fuses for the mains voltage in the location where the ESU will be used c Use a flat blade screwdriver to remove the covers from each of the two FUSE RECEPTACLES by turning the covers approximately 1 4 turn to the left d Insert one of the chosen fuses in each of the two FUSE RECEPTACLE covers e Re insert the two FUSE RECEPTACLE covers with fuses installed into the FUSE RECEPTACLES f Use a flat blade screwdriver to gently push each of the two covers into the FUSE RECEPTACLES and rotate each one approxi mately 1 4 turn to the right to lock them in place g Connect the power cord to the back of the ESU Installation of the ESU may now be completed WARNING THE POWER CORD OF THE ESU SHOULD BE CONNECTED TO A PROPERLY POLARIZED AND GROUNDED POWER SOURCE WHOSE VOLTAGE AND FREQUENCY CHARACTERISTICS ARE 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 I
24. 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 39 HAND CONTROLLED MONOPOLAR ACCESSORY RECEPTACLE Two inde pendent receptacles are provided for the con nection of hand controlled monopolar acces sories Only by the accessories connected to them may activate these receptacles 40 BIPOLAR ACCESSORY RECEPTACLE Bipolar output is activated by the bipolar foot controlled or by hand controlled bipolar accessories CONMED accessories with fixed connection style plugs are recommended for this receptacle For legacy connections with two banana plug leads connect these active bipolar forceps leads to the outside connec tions 41 POWER SWITCH Primary power switch for turning the ESU on and off 2 6 43 SPEAKER Sound from the speaker ema nates from this location 44 NAMEPLATE Specifies model number serial number nominal line voltages frequen Cy current and fuse rating information 45 FAN Forced air from the temperature con trolled fan is expelled in this location 46 BIPOLAR FOOTSWITCH CONNECTOR A 3 pin threaded con nector designed to accept any CONMED Electrosurgery single treadle bipolar footswitch 47 MONOPOLAR FOOTSWITCH CONNECTOR This 4 pin threaded con nector is designed to accept plugs attached to any dual treadle monopolar footswitch available from CONMED Electrosur
25. 1 2 5 1 2 6 1 2 7 1 2 8 1 2 9 1 2 10 13 11 1 3 1 3 1 1 3 2 1 3 3 1 3 4 1 4 2 0 2 1 2 2 2 2 1 2 3 2 3 1 2 3 2 2 4 2 4 1 2 4 2 2 4 3 2 5 2 6 2 6 1 2 6 2 SESTENM 5000 Table of Contents List of Illustrations Title Page General Informatio yoga vcs der PEU CHER UNDE EE MEM r ER ERENER 1 1 CAUTIONS Sos eri eei teen anoo ua Ey su suae se S YER e EY Se 3 kN Xe S ua PN RE ENVER E 1 1 Cautions For Equipment Preparation eee eene enn 1 2 Cautions For Patient Preparation ect mti i Ho OR HERO ESSERE TR RARI 1 2 CAUTIONS For SC isaac cae nite oor can AA EE unies su ode uei eina eu Dabo e ven aul neu eee eel 1 4 Cautions For Testing or Servino skori beer rra n a Plein owavevesosedvabbewstieua tobias 1 5 Electromagnetic Compatibility 5 2 5 tp betae co PEOR e HER EPIO EQ R ER uE ERR NEL QR ERU OEUN 1 6 EN IEC 60601 1 2 Table 201 0 ccccccccccccceccceesssseceeeeeceesesssseseeececeeserssseeeeceseeenesssaeees 1 6 EN TEG 606012122 Table 202 ss 5 peste eaten deb tU e toes ont atte deta to vp d uei 1 7 EN IEC 60601 1 2 Table 204 ssssssssssssseeeneneneneen e In enne ne enm nne n eren netiis 1 8 EN IEC 60601 1 2 Table 206 00 ccccccscsccecececeesensecececeeeesesssseceseesesesessseceeeesenesensaeees 1 9 SPECICATION M 1 9 Mains Overcurrent Protection ccccceccccceccceeseseeeeccceeeseuueseseccceeseaseaseeeeeeeeessaaeeeeeeeeeseaaens 1 9 Mains Frequency Leakag
26. DSWITCHED ACTIVE CONNECTIONS BIPOLAR FOOTSWITCH CONNECTIONS RF Ce E HANDSWITCH OPTIONAL e BIPOLAR ACTIVE CONNECTIONS Figure 2 4 Accessory Schematics Figure 2 5 Accessory Connections 2 14
27. E STATUS ALARM INDICATOR Indicates the status of a dual dispersive electrode 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 dual dispersive electrode application The STATUS INDICATOR will flash red prior to connection of any dispersive electrode or connection of a dual dispersive electrode that is not applied to the patient This indi cator 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 first activa tion using a hand control or footswitch 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 qual ity between the two elements of the dual 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 ESU will be indicated by illumination of one or more segments All of the BARGRAPH segments will be illuminated upon activation with an accept ably installed and connected dispersive elec trode Fewer segments of the bar graph will 507 s000 be illuminated as the contact quality of the If
28. IRE UN RUE UN RU DPI REO FR PD NR UD EUN Ru 2 12 2 7 4 Periodic Performance Testing itae Pero ee ro np ere e e Re MR raid 2 12 2 8 In Case of Diticulty 2 12 2 8 1 Dispersive Electrode Alarm seii ertt retener reti rta eaa e OR E dean EEA 2 12 2 8 1 1 Single Dispersive Electrode Arn defe rero ra bend pe bere re beris 2 12 2 8 1 2 Dual Dispersive Electrode Alarm e d tet tree ten tea P RR e PII Ra feo 2 13 2 8 2 INCE COGS RARE RM E 2 13 2 8 3 Emr COdes ceu resi edu eM RM EI Ree 2 13 2 8 4 TE ATL Else Eails 2 iie ertet ettet a aed dee eed a eese deba Te dise a aD d 2 13 2 9 Environmental Protection eee eee eese ee eee eene eene nenne eren reete sten eren 2 13 Figure Title Page Figure 1 1 Output Power vs Power Seting ssc eset erret ene a re er RE Seo dh eee EY eiue age 1 14 Figure 1 2 Display vs Open Circuit Peak Voltage esee 1 14 Figure 1 3 Load Regulation Monopolar Pure Cut sse 1 15 Figure 1 4 Load Regulation Monopolar Blend 1 onere the erp re iet d eres 1 15 Figure 1 5 Load Regulation Monopolar Blend 2 sss eee 1 16 Figure 1 6 Load Regulation Monopolar Blend 3 sss 1 16 Figure 1 7 Load Regulation Monopolar Pinpoint Coag sss ee 1 17 Figure 1 8 Load Regulation Monopolar Standard Coag sss 1 17 Figure 1 9 Load Regulation Monopolar Spray Coag
29. LAR COAG 36 REMOTE POWER POWER ADJUSTMENT KEYS CONTROL KEY 26 COAG SCROLL KEY Figure 2 1 Control Panel E e oo 11 BLEND 1 INDICATOR Illuminates when monopolar Blend 1 is selected 12 BLEND 2 INDICATOR Illuminates when monopolar Blend 2 is selected 13 BLEND 3 INDICATOR Illuminates when monopolar Blend 3 is selected 14 PULSE CUT INDICATOR Illuminates when Pulse Cut is selected 15 MONOPOLAR CUT POWER DIGITAL DISPLAY Indicates the power setting for the currently selected monopolar cut mode 16 MONOPOLAR CUT ACTIVATION INDICATOR This yellow indicator lights when the ESU is activated in a monopolar cut mode 17 CUT MODE SCROLL KEY Pressing this key will scroll through the Cut Modes Pure Blend 1 Blend 2 and Blend 3 18 MONOPOLAR CUT POWER ADJUSTMENT KEYS Adjusts the output power setting of the selected cut mode 19 PULSE CUT KEY Pressing this key will select or deselect Pulse Cut 20 PINPOINT COAG INDICATOR Illuminates when monopolar Pinpoint coagu lation has been selected 21 STANDARD COAG INDICATOR Illuminates when monopolar Standard coagu lation has been selected 22 SPRAY COAG INDICATOR Illuminates when monopolar Spray coagulation has been selected 23 PULSE COAG INDICATOR Illuminates when Pulse Coag is selected 24 MONOPOLAR COAG POWER DIGITAL DISPLAY Indicates the power setting in the currently selected monopolar coagulation mode 25 MONOPOLAR COAG ACTIVATION
30. ODE program locations STATUS ALARM INDICATOR DOES NOT PROVIDE ANY INDICATION OF 9 PROGRAM STORE KEY Stores the current THE CONTACT QUALITY BETWEEN settings into the selected program location THE SINGLE DISPERSIVE ELECTRODE 10 PURE CUT ACTIVATION INDICATOR AND THE PATIENT Illuminates when monopolar Pure Cut Mode has been selected 10 PURE CUT MODE 16 MONOPOLAR CUT 20 PINPOINT COAG A e ACTIVATION INDICATOR ques hA ia 1 STANDARD AN ramos POWRDGILDSUAY NDCNOR unco INDICATOR 14 PULSE CUT 1 T INDICATOR POWER DIGITAL DISPLAY 13 BLEND 3 INDICATOR INDICATOR EN 25 MONOPOLAR COAG 27 MICRO BIPOLAR 1 DUAL DISPERSIVE ELECTRODE 23 PULSE COAG ACTIVATION INDICATOR STATUS ALARM INDICATOR I INDICATOR 30 MACRO BIPOLAR MEE INDICATOR 7 31 BIPOLAR ACTIVATION INDICATOR 32 BIPOLAR OUTPUT METER 2 SINGLE DISPERSIVE ELECTRODE STATUS ALARM INDICATOR 3 GENERAL MODE INDICATOR b 33 BIPOLAR POWER 4 FLUIDS SPECIALTY DIGITAL DISPLAY MODE INDICATOR 5 LAP SPECIALTY MODE INDICATOR 6 PROGRAM INDICATOR 7 SPECIALTY MODE SCROLL KEY 8 PROGRAM SELECT SCROLL KEY 2 9 PROGRAM lt STORE KEY 35 BIPOLAR POWER ADJUSTMENT KEYS 17 CUT MODE N 34 BIPOLAR SCROLL KEY SCROLL KEY 18 MONOPOLAR CUI T POWER ADJUSTMENT KEYS 28 PULSE COAG KEY 19 PULSE CUT KEY 27 MONOPO
31. Pressing the Cut Mode Scroll Key and verifying that the settings for each of the other modes were not changed by chang ing the Pure Cut 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 Bipolar Micro Bipolar Macro Pulse Cut Pulse Coag FLUIDS Specialty Mode LAP Specialty Mode Return all settings to the desired setting 10 Select each of the specialty modes by press ing the Specialty Mode Scroll Key and verify ing that the selected specialty mode scrolls through General Fluids and Lap Verify that the displayed power settings for each specialty mode can be changed independently of the other modes by adjusting the cut coag or bipolar power Return all settings to the desired setting and return the specialty mode to General before proceeding 11 Depress the bipolar footswitch Confirm that the Bipolar Activation indicator illumi nates and a bipolar activation tone is sounded While continuing to depress the bipolar footswitch rotate the Volume Control over its full range to verify the function of that control and that sound is audible at all posi tions This control may be left at any desired position Release the bipolar footswitch and confirm the System 5000 returns to its idle state
32. Q 9 9s Selection Scroll Button E 3 2 Interior Protective Earth Inlet Connector QD High Voltage Circuitry 1 3 3 Output Control Panel Dispersive Electrode Connection for monopolar dis persive electrode ReadiPlug Universal Accessory Receptacle Hand controlled Monopolar Output Connection for hand controlled monopolar accessories Bipolar Output Connection for bipolar accessories 1 Caution High voltage output 199 Type CF Patient connections are iso lated from earth and resist the effects of defibrillator discharge RF Isolated Patient connections are isolated from earth at high frequency f Consult accompanying documents prior to placing equipment in service E o 5000 l Power on connected to the mains O Power off disconnected from the mains 1 3 4 Rear Panel IPX1 A ry Ea un ee oe Enclosure resists entry of vertically falling water Consult accompanying documents prior to placing equipment in service This equipment intentionally supplies non ionizing RF energy for physi ological effect Explosion risk if used in the presence of flammable anesthetics Do not operate in oxygen enriched environments Bipolar Footswitch Connector Monopolar Footswitch Connector Activation relay connector iu A IOIOI Equipotential Ground Terminal Replace fuse only with type and rat ing as shown Caution High Vol
33. Section 1 4 and Figure 2 4 Use of other accessories may result in increased emissions or decreased immunity of the ESU Reusable accessory cables should be periodi cally function and safety tested in accordance with the original manufacturer s instructions Visually inspect all accessories before each use to verify the integrity of insulation and the absence of obvious defects In particular elec trode cables and endoscopic accessories should be checked for damage to the insulation The System 5000 is equipped to connect three monopolar accessories at one time for the convenience of the surgical staff Unused accessories should be stowed in a safe electri cally insulated place such as a non conductive holster isolated from the patient CONMED recommends accessories not be connected unless needed Never connect more than one accessory at a time to any one receptacle not including the dispersive electrode receptacle when the appropriate CONMED adapter is used Use only a hospital grade 3 prong power cord rated to meet the specifications in Section 1 2 and all of the requirements for safe grounding of the ESU The user should verify that the power receptacle with which this ESU is used is properly grounded cor rectly polarized and of the proper frequency per Section 1 2 Do not use ground cheater plugs or extension cords Do not place liquid containers on top of the ESU Wipe spilled liquids off the ESU im
34. Testing trin iranan ann teda pe Eo PER n a E EURR RENE ER eR Fan 2 3 Controls Displays and Connectors ssssisccssnssscsstonsennssebsactansssanmessseecabsestanaacs 2 3 Control Panels eet three sees asset lusus due E sa siedheweuauenh DES MN E EEUU RUDI E QUEUE 2 3 Output Panel torti eerte tiet sere red AAE EERE b ve ovk vea eh ree vA nestle 2 5 Rear PATI NR Rm 2 6 Set Up F r Usen sisenes M 2 7 Oae ralo Er a A 2 10 General NRI 2 10 Monopola Pulse Qut cn titt e oe Dni OO EA iE 2 10 507 s000 Section Title Page 2 6 3 Monopolar Pulse COag ote nec etie te Gd reri dri Ta HR e ed b 2 11 2 6 4 Fluids Specialty Mode ctt to rt of bte I FEAR t daudadeaveas 2 11 2 6 5 Lap Specialty Mode t ehe rtt ted RI e ede eR IN Pedes Fo Dus kae t et re D PRU ters 2 11 2 6 6 PLOG CARMI pm 2 11 2 6 6 1 Storno Programi Saarinen raaa E RAEAN T 2 11 2 6 6 2 IU sing PEOSFAEIIS as coi pte ee n ERE OR pee Y EY ERR bute E NUR ro bu eR dea DUE 2 11 2 6 7 Remote Power Control iieri visse dme e I du IAS T 2 11 2 6 7 1 Changing Monopolar Power Remotely ssseessssesese eene 2 12 2 7 User Maintenance 5 e aee ere o ee ooo enn er En aee eo a E eara rase ense Ee noe go e ao KESED NEES eu Us 2 12 2 7 1 General Maintenance Information es n e et t ae cea ve vUa EEUU VEN E Pu SU eos au RR VUES 2 12 2 7 2 e inj aeir A AA E Canantsn oats eta tut tives t saath voce deine E 2 12 257 9 Periodic Inspection isinisi nre retire pee L XR ECR
35. and people 1 2 Specifications Input Power 600 watts maximum Frequency Mains Bia i VRMS Mains Current ARMS uses m rere Fuses are Type T High Breaking 1 2 1 Mains Overcurrent Protection Two fuses for each ESU with ratings as noted in the table above 1 2 2 Mains Frequency Leakage Designed to comply with IEC60601 1 1995 Patient connections to Neutral Less than 10 uA Chassis to Neutral Less than 25 uA 120V Less than 45 uA 240V re z 507 2 MEEENNNNNNNNNNNNNNNNNNNNNNNNNNNNNI 1 2 8 Regulatory Compliance Designed to comply with Medical Electrical Equipment Standards UL2601 1 2000 IEC60601 1 1995 IEC60601 1 1 2000 IEC60601 1 2 2001 IEC60601 1 4 2000 IEC60601 2 2 1998 ANSI AAMI HF18 2001 Manufactured in an ISO 13485 2003 Registered Facility Type of protection against electric shock IEC Class 1 Degree of protection against electric shock Type CE Defibrillator Proof Non Ionizing Radiation 1 2 amp Operation Mode of operation Intermittent 10 Sec on 30 Sec off 1 2 5 Power Display Accuracy The greater of 10 of display or 3 watts at rated load 1 2 6 Line Regulation Power Change lt 1 V for the range of line voltages specified 1 2 7 Environmental Operating Conditions 10 C to 30 C 95 RH Non condensing maximum Degree of protection against Ingress of Water IPX1 Protection against vertically falling water drops Mounting Restriction 2 inch 5cm clearance required
36. as where pressure points on small areas might develop Because of the risk of burns needles should never be used as a dispersive electrode for N 5000 electrosurgery The entire area of the disper sive electrode should be placed so that the entire conductive area is in firm contact with an area of the patient s body that has a good blood supply and is as close to the operative site as possible In general electrosurgical current paths should be as short as possible and should run either longitudinally or in a diagonal direction to the body not laterally and under no circumstances lateral to the tho rax Dispersive electrodes and probes of monitor ing stimulating and imaging devices can provide paths for high frequency currents even if they are battery powered insulated or isolated at 50 60 Hz The risk of burns can be reduced but not eliminated by placing the probes as far away as possible from the electrosurgical site and the dispersive elec trode Protective impedances incorporated in the monitoring leads may further reduce the risk of these burns Needles should not be used as monitoring electrodes during electrosurgical procedures When high frequency surgical equipment and physiological monitoring equipment are used simultaneously on the same patient all monitoring electrodes should be placed as far as possible from the surgical site and disper sive electrode Needle monitoring electrodes are not
37. ased which decreases the resistance causing more segments to illuminate As the tissue between the bipolar tines becomes more desiccated fewer elements of the bar graph will be illuminated When the desic cation reaches a point where one element of the bar graph is illuminated the Bipolar Output Tone will sound Note Depending on the volume of tissue between the tines the Bipolar Output Meter movement could occur quite rapidly Ensure that the tone volume is properly set prior to using the Bipolar Output Tone feature Bipolar Output Tone volume can be set while activating in Bipolar mode with forceps open 16 Select Pulse Cut for pulsing bursts of cut energy for precise dissection with minimal thermal necrosis 17 Select Pulse Coag for pulsing bursts of coagulation energy for precise hemostasis in STANDARD or SPRAY modes Pulse Coag cannot be selected while PINPOINT is selected 18 Adjust the CUT COAG and BIPOLAR power settings to the desired levels in the fol lowing manner 2 9 5077 HGH tne nc ee ee To increment or decrement the power setting one step momentarily press and release the desired CUT COAG or BIPOLAR Power Adjustment Key The power setting will increase one step and a short tone will sound To increase or decrease the power set ting a 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 setting will i
38. ator It is important that the instructions supplied Ad a with this equipment be read understood and followed in order to ensure safe and effective use of the equipment Only properly quali fied and trained operators should perform electrosurgery The operator and their sup port personnel must be diligent in assuring that the ESU is properly configured and that proper settings are used The ESU must be located to assure the operator or their support personnel can readily verify the settings PLEASE NOTE Federal law U S A requires that all health care facilities must report to the manufacturer of a medical device any death or serious injury or illness to a patient related to the use of a medical device Serious injuries or illness involving the use of a medical device must be reported to the manufacturer of the device or to the FDA if the manufacturer of the device is not known within 10 working days of the inci dent Summary reports of such injuries must also be submitted directly to the FDA twice a year Patient deaths related to the use of a medical device must be reported to the manu facturer and the FDA For further informa tion please contact the Regulatory Affairs Department of CONMED Electrosurgery at 800 552 0138 303 699 7600 or FAX 303 699 9854 Do not use monopolar electrosurgery on small appendages as in circumcision or finger sur gery as it can cause thrombosis and other unintended injury to tis
39. be those just prior to the loss of power The 0 zero location sets all power settings to zero and the activation modes to Pure Cut Standard Coag and Bipolar Micro The settings 1 9 contain user stored settings 2 6 6 1 Storing Programs 1 Select the desired storage location BEFORE setting the desired modes and power settings As each location is shown the displays will indicate the contents of that location 2 Set the modes power and pad settings as desired Note that non displayed mode set tings are also stored at this time 3 Press the STORE key If a correction is needed simply set the machine as desired and press STORE again Confirm the program settings are correct before use 2 6 6 2 Using Programs Select the stored setting location by scrolling through the program locations using the Program Select Scroll key Confirm the program settings are correct before use 2 6 7 Remote Power Control Remote Power Control provides the surgeon with the ability to change power settings from the surgical field using the activation switches on the monopolar accessory CAUTION The Remote Power Control fea ture 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 being per formed until normal operation is restored The Remote Power Control may only be activated when
40. ctive electrosurgery 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 6 2 8 Apply the dispersive electrode over a well vas cularized muscle mass that is thoroughly clean and dry Clean and clip site as necessary to provide adequate electrical connection and per hospital policy Avoid placement over scar tis sue bony prominences or other areas where pressure points on small areas might develop Inspect and connect the plug of the dispersive electrode 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 ESU if its requirements for the dispersive electrode have not been satisfied see instruction 8 The A R M dispersive electrode contact quality monitor can automatically detect and accept either single dispersive electrodes or dual dispersive electrodes The Single Dispersive Electrode Status Alarm Indicator indicates the status of a single dispersive electrode when the single disper sive 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 Di
41. ducted in fluid mediums by providing an initial energy burst when activation is initiated 2 6 5 Lap Specialty Mode Lap Specialty Mode provides optimal safety by limiting output voltage which minimizes the potentially harmful effects of capacitive coupling and insulation failure Users will notice that Standard Coag and Spray Coag will have a gen tler coagulation effect that 1s shorter arcs and a smaller clinically affected area when Lap Specialty Mode is selected When a more aggressive coagu lation effect is desired Pinpoint Coag Standard Coag or Spray Coag in the General Mode can be selected When selecting General Mode from Lap Specialty Mode expect a more aggressive surgi cal effect and adjust power accordingly Always use the lowest power setting necessary to get the desired clinical effect Refer to the instructions provided by the manufacturer of the laparoscopic accessory concerning maximum voltage specifica tions 2 6 6 Programming Up to 9 complete mode and power settings can be easily stored and recalled at any time Additionally there are two settings that the unit automatically sets I and 0 zero The unit automatically stores the most recent set tings when powering down and will restore those settings when the unit is turned ON An P for Last will be displayed in the Program Location Indicator Note that if a power loss occurs dur ing activation the values stored in the P location will
42. e ete tree eene ha olco e REN PH eee HA Rh ENEE 1 9 Repulatory Sensu T HP 1 10 usce M 1 10 Power Display Acc faey eh die t ed i i dea De o e E AO RU edad Red ie nn 1 10 Lane R gulatioB 5 eee rettet HEIDI DE AU tU ER SO e XX Run S 1 10 Enyironmettal 55 nere De invi ri tei vs ID s 1 10 Contact Quality MONIO ssi eris terri ee eh ero GO e d ped OE EE RE idR ES 1 10 Audio Specificatiohs siis irri aa er vi S a eri Roe aU RR WR e ES ER E Re EN a HERE TR uota ve RU Eau 1 10 Othet SPECIFICATIONS anea codec nterasutte ncaa he EEE A EE ceed RAE 1 11 Operating Modes and Nominal Output Parameters essere l 11 Explanation f Symbol Ssssccsisisessscssessessiscanacsesssdanseneseacnesensacessesavsesensassenstes 1 12 Control Panel once eU MEE LS LM IARE 1 12 DG es OTOI EA err rn ILI Me ML AM E DU Med MEE 1 12 Output Control Panel nee cent ere PRSE re i E A A E ES 1 12 Rear Bs el Fe SI OSU Tn E 1 13 Output Characteristic Carves as ccssscssscessscsnscsenessaswcseseassvsessescnsasasastssscssesstes 1 14 Installation and Operation cecsscoato iov aa aea qoi e a SO E REN DAS dI ERR FEEDS 2 1 Initial crise ro EP 2 1 Installati n EEEETOEITRITETRLTITOTTIOOT ELICIT DIDTTLEEEEER 2 1 Installation OF Buses iita thu dat tete fei vierte Mese t 2 1 Preliminary M 9 2 1 Preliminary Functional Testing rrt Ere E PEN AS ne excede Re ene 2 1 Preliminary Performance
43. e size electrode geometry power level and surgical technique The size and geometry of monopolar electrodes are significant in that a large electrode absent of sharp features e g a ball electrode will have no tendency to cut regardless of the output power level Conversely a small sharp electrode such as a needle or wire loop will be likely to cut simply from mechanical pressure at conservative power settings Note that other generator models will have different clinical effects than the System 5000 even when power settings are the same The Bipolar Coagulation waveform is designed to minimize tissue sticking and popping by limiting the output voltage regardless of the power set ting Bipolar 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 2 Monopolar Pulse Cut Monopolar Pulse Cut provides pulsing bursts of cut energy for precise dissection In Monopolar Pulse Cut Dissection will occur in 70 ms durations every 600 ms Each pulse will typically dissect less than 1 mm depending on the power setting the electrode size and type and the mass of the tissue being dissected Two distinct tones are audible during
44. e placed on the patient This is especially important for laparoscopic procedures Ensure that the footswitches are not inadver tently depressed in order to prevent acces sories from being unintentionally activated Place footswitches in locations that necessi tate deliberate action in order to activate the footswitch Use caution when selecting the correct footswitch to activate 1 1 4 Cautions For Testing or Servicing Service should not be attempted without refer ence to the System 5000 service manual Catalog Number 60 8017 ENG 1 5 5077 qq Ht nnn nnn nc ee ee This electrosurgical unit should be tested by a Hospital Qualified Biomedical Technician on a periodic basis to ensure proper and safe operation It is recommended that examina tion of the ESU be performed at least yearly Refer all servicing to a Hospital Qualified Biomedical Technician Your CONMED sales representative will be happy to assist you in getting your equipment serviced High voltages are developed within the ESU that are accessible when the top cover is removed These voltages are potentially dan gerous and should be treated with extreme caution The high voltage DC power supply in the System 5000 is equipped with a bleeder resistor to dissipate the charge on the filter capacitor However it takes several seconds after power is removed to bleed that charge down to a safe level It is recommended that at least thirty 30 s
45. eaning and disinfection wherever possible Exercise care when relocating the ESU to avoid electrostatic charge buildup in the pres ence of flammable materials as there is a risk of igniting these materials if a spark should occur This ESU is equipped with the Automatic Return Monitor A R M which monitors the quality of the dispersive electrode con nection When a correctly functioning single dispersive electrode is connected to the ESU A R M verifies the connections 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 disper sive 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 opera tion The use and proper placement of a dispersive electrode is a key element in safe and effec tive electrosurgery 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 vas cularized muscle mass that is thoroughly clean and dry Clean and clip site as necessary to provide adequate electrical connection and per hospital policy Avoid placement over scar tis sue bony prominences or other are
46. econds be allowed to elapse before touching or attempting to per form any maintenance involving the power supply or power amplifier Never remove or install any parts with the power cord connected to AC mains Avoid contact with the output leads when the ESU is activated Periodically inspect the test leads used for the output connections for obvious defects 1 1 5 Electromagnetic Compatibility Although this ESU will withstand momentary short circuits on the output prolonged short circuits may damage the ESU Short circuit ing the output should be avoided since it is neither necessary nor desirable Since the clinical use of electrosurgical units 1s intermittent in nature with duty cycles on the order of 1096 this ESU is not designed to operate for extended periods of continu ous output When testing it is recommended that duty cycles be limited to 10 seconds activation with delays of 30 seconds between activations Activating the System 5000 in other than its normal operating position impairs the heat dissipation capability of the heat sink Ensure that the two top cover screws are tight ened and always perform a power up check to confirm a normal power up sequence before returning the ESU to service Improperly connecting test equipment can cause electric shock and destruction of equip ment Turn unit off and wait until storage capacitors have discharged before connecting test equip ment
47. etal items that are ground ed or have an appreciable capacitance to earth Examples of this would be operating tables supports etc Jewelry and other metallic items can cause localized burns if they make contact with grounded items and should be removed from the patient prior to use of electrosurgery Skin to skin contacts such as between the arm and body of a patient or between the legs and thighs should be avoided by the insertion of dry gauze The use of electrosurgery on patients with cardiac pacemakers AICDs neurostimulators or other active implants is potentially hazard ous The implant may be irreparably dam aged and or the high frequency energy of the electrosurgical output may interfere with the function of the implant Ventricular fibrilla tion may occur Precautions should be taken to ensure the patient s well being is main tained in the event of such interaction The manufacturers of the implants should be con sulted for advice before operating on a patient with an implant These precautions also apply to operating room personnel with similar implants To minimize the possibility of cardiac pace maker interference place the dispersive elec trode such that the electrosurgical current path does not intersect the path of the pace maker or leads 1 1 3 Cautions For Use Safe and effective electrosurgery is dependent not only on equipment design but also on factors under the control of the oper
48. f 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 3 Preliminary Checks Prior to initial installation and use of this ESU performance of the device should be tested in accordance with this manual Results of that test ing should be compared to the results tabulated on the factory Test Data Sheet supplied with each ESU This data should be retained for future ref erence and comparison 2 3 1 Preliminary Functional Testing The following checks are recommended upon ini tial installation of the equipment and prior to each use of the instrument to avoid unnecessary delays in surgery See Figure 2 1 for location of controls and connectors 2 1 d a 2 2 Ensure the power switch is OFF and no accessories are connected Connect the power cable to a properly grounded and polarized mating power recep tacle of the proper voltage and frequency Connect a CONMED dual treadle monopolar footswitch and a single treadle CONMED bipolar footswitch to their mating connec tors at the rear of the ESU Note Use only CONMED Electrosurgery footswitches Although other types may fit they may not be functionally compatible Make no connection to the dispersive elec trode receptacle at this time Set the Power Switch to the ON posi tion As the ESU goes through the internal self diagnostics it sh
49. gery Use only CONMED Electrosurgery footswitches Other manufacturer s footswitches may not be compatible 48 ACTIVATION RELAY CONNECTOR A receptacle for actuating smoke evacuators and sumilar devices when delivering electrosurgical output The maximum contact rating for this receptacle is 1 amp at 24 volts DC Verify that devices connected to this output func tion properly in a manner that is synchronized with ESU power delivery prior to use 42 CARRYING HANDLE 43 SPEAKER o o o o o o o 46 BIPOLAR 47 MONOPOLAR FOOTSWITCH FOOTSWITCH CONNECTOR CONNECTOR 48 ACTIVATION RELAY CONNECTOR SYSTEM 5000 44 NAMEPLATE 45 FAN HOSPITAL GRADE RECEPTACLES 91 POWER INLET 53 BIPOLAR CURRENT 54 VOLUME VOLUME CONTROL CONTROL 50 EQUIPOTENTIAL GROUND CONNECTION 52 SERIAL INTERFACE CONNECTOR Figure 2 3 Rear Panel 49 FUSE RECEPTACLES For installation of two mains fuses with ratings as noted in Section 2 2 1 50 EQUIPOTENTIAL GROUND CONNECTION Chassis ground connection suitable for attachment of standard auxiliary grounding cable when required for additional protection against low frequency risk current 51 POWER INLET Supplies AC mains power to the ESU It should only be connected to a source of power corresponding to that listed on the nameplate 52 SERIAL INTERFACE CONNECTOR This connector provides a means of connec tion with operating room control centers Only equipment approved
50. mediately To preclude inadvertent entry of liquids do not operate this ESU except in its normal position Do not stack other devices or equipment on top of or adjacent to the System 5000 The CONMED Stacking Adapter Cat No 1 2 60 8030 001 allows two System 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 only 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 accesso ries 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 ESU could cause an unintend ed increase in output power Verify that the ESU is functioning correctly prior to use Prior to use verify that devices connected to the Activation Relay Connector function properly in a manner that is synchronized with ESU power delivery Equipment connected to the Serial Interface Connector must be approved by CONMED and must be connected in accordance with instructions accompanying the eq
51. ncrease or decrease in step increments with a short tone for each step If the key is continuously held after the ninth step power setting 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 low power settings initially 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 2 6 1 General WARNING ENSURE THAT THE FOOTSWITCHES 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 COR RECT FOOTSWITCH TO ACTIVATE Activate the electrosurgical unit in the desired operating mode by depressing the appropriate treadle of the footswitch or switch of a hand controlled accessory Adjust the corresponding power setting until the desired surgical effects are obtained Power setting changes are limited when the ESU is activated to the greater of 10 watts or 25 of the dial setting upon initiation of activation The power setting will be displayed on the digital dis play for each mode 2 10 The surgical effects obtained are dependent on a number of factors including waveform electrod
52. nd Coag buttons on the accessory one at a time verifying that each control causes the correct indicator and tone to sound Move the hand controlled acces sory to the other Monopolar Accessory Receptacle and repeat 16 Disconnect the single dispersive elec trode and confirm that the System 5000 beeps three times and the Single and Dual Dispersive Electrode Status Alarm Indicators alternately flash red 2 3 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 If no tester is convenient the availability of thera peutic current may be ascertained subjectively by attempting to cut and coagulate on surrogate tis sue such as a piece of meat or fresh fruit a wet bar of soap or a sponge moistened with saline 2 4 Controls Displays and Connectors The numbers preceding the following paragraphs correspond to the numbered items in Figures 2 1 2 2 and 2 3 2 4 1 Control Panel All controls except for the volume controls are located on the front control panel Figure 2 1 illustrates the Universal Symbols control panel Your control panel may be in English 1 DUAL DISPERSIVE ELECTROD
53. ould respond by a Sounding a series of test tones b During the test tone displaying a total of nine 48 s on the four digital displays c Illuminating all three activation indica tors all eight key indicators two disper sive electrode indicators and the entire dual dispersive electrode contact quality BARGRAPH d After the display test the ESU will show the software revision level in the COAG display window The ESU is conducting a power on self test during this interval e If there are no errors normal operational parameters will then be displayed Depress the Cut treadle of the monopolar footswitch The dispersive electrode alarm should sound and dispersive electrode indica tors should flash alternating red While hold ing the Cut treadle rotate the volume control over its full range and verify there is no sig nificant change in sound level Release the Cut footswitch and the tone should stop Select each of the modes by pressing the Mode Scroll Keys and note the displayed power settings for each mode in the corre sponding displays Verify that the Pure Cut Mode can be selected and adjusted up and down by Pressing the Cut Mode Scroll Key until the Pure Cut Activation indicator is illu minated 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
54. r hospital environment Mains power quality should be that of a typi cal commercial or hospital environment If the user of the System 5000 Electrosurgical Unit requires continued operation during power mains interruptions it is recommended that the System 5000 Electrosurgical Unit be powered from an uninterruptible power sup ply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level 1 7 5070 o EEENNNNNNNNNNNNNNNNNNNNNNNNNNNNNNI 1 1 5 3 EN IEC 60601 1 2 Table 204 Guidance and Manufacturer s Declaration Electromagnetic Immunity The System 5000 Electrosurgical Unit is intended for use in the electromagnetic environment specified below The customer or the end user of the System 5000 Electrosurgical Unit should assure that it is used in such an environment Immunity Test IEC60601 test Compliance Electromagnetic environment guidance level level Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 Portable and mobile RF communications equipment should be used no closer to any part of the System 5000 Electrosurgical Unit including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3 Vrms d 1 2VP 150 kHz to 80 MHz 3 V m d 1
55. recommended Monitoring systems incorporating high frequency current limiting devices are recommended whenever possible The active electrode should not be used in the vicinity of electrocardiograph electrodes Heat applied by thermal blankets or other sources is cumulative with the heat pro duced at the dispersive electrode caused by electrosurgical currents Choosing a disper sive electrode site that is remote from other heat sources may minimize risk of a patient injury Electrosurgery by its nature produces signifi cant levels of electromagnetic interference EMI when the ESU is activated This EMI may damage or impair the function of other electronic equipment in the operating room especially equipment that makes contact with the patient Adverse effects can only be mitigated by use of equipment specifically designed to tolerate electrosurgical interfer 1 3 ence Cables subject to flexing should be inspected frequently for shielding integrity Other equipment in the operating room including portable or mobile communica tions equipment may produce EMI which can affect the function of the ESU Adverse effects can only be mitigated by use of equip ment with EMI characteristics proven below recognized limits In the event of suspected interference from other equipment discon tinue use of the ESU until the problem can be remedied The patient should not be allowed to come into contact with m
56. red which is approximately half the power delivered during the pulses LAP Specialty Mode output parameters match general operation parameters except the maximum voltage is limited to less than 2700 Volts peak FLUIDS Specialty Mode output parameters match general operation parameters with an initial energy boost upon activation to initiate an arc S 7557 A7 5000 1 3 Explanation of Symbols 1 3 1 Control Panel Note International System 5000 units use symbols on the Control Panel Some symbols are replaced by words on the domestic U S units These words are indicated by bold text in the sym bol description s Pure Cut waveform with minimum ther mal damage and hemostasis 4 Ji Blend 1 waveform with moderate WS hemostasis Blend 2 waveform with medium hemostasis Blend 3 waveform with maximum hemostasis Pinpoint Monopolar Coagulation Standard Monopolar Coagulation Spray Monopolar Coagulation E LC Macro Bipolar Coagulation Micro Bipolar Coagulation General Setup Fluids Specialty Mode Lap Specialty Mode Single Dispersive electrode Status Alarm Indicator for single monopolar dispersive electrodes Dual Dispersive electrode Status Alarm Indicator for dual monopolar dispersive electrodes fh tth Bipolar Output Current Indicator i Pulse Mode l 12 Remote Power Control Key Press to enable or disable Remote Power Control Program Program Store Key O
57. spersive Electrode Status Alarm Indicator DOES NOT provide any indication of the contact quality between the single dispersive electrode and the patient If the connection between the ESU and the single dispersive electrode is broken the Single Dispersive Electrode STATUS INDICATOR will flash 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 ESU This indicator is made up of a BARGRAPH which indicates the relative quality of the dual dispersive electrode appli cation and a STATUS INDICATOR The STATUS INDICATOR will flash red prior to connection of any dispersive elec trode or connection of a dual dispersive elec trode 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 disper sive 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 electrode that is installed and connected with acceptable contact quality Prior to activation the BARGRAPH will show a relative measure of the contact qual ity between the two elements of the dual dispersive electrode Good contact quality is indicated by illumination of many segments while poor contact quality will illuminate
58. sue proximal to the surgical site Should the surgeon decide that the bipolar electrosurgical technique is accept able for circumcision do not apply the bipolar electrosurgical current directly to circumcision clamps Apparent low power output or failure of the electrosurgical equipment to provide the expected effect at otherwise normal settings may indicate faulty application of the disper sive electrode failure of an electrical lead or excessive accumulation of tissue on the active electrode Do not increase power output before checking for obvious defects or misap plication of the dispersive electrode Check for effective contact of the dispersive electrode to the patient anytime the patient is moved after initial application of the dispersive elec trode E 5557617 5000 Studies have shown that smoke generated dur ing electrosurgical procedures may be harmful to surgical personnel These studies recom mend using a surgical mask and adequate ven tilation of the smoke using a surgical smoke evacuator or other means In the event that the system resets due to a power interruption or low voltage check the contact of the dispersive electrode prior to resuming electrosurgery If a dispersive electrode or A R M alarm is sounded intraoperatively physically confirm proper dispersive electrode attachment to the patient and confirm that the display falls with in the set range Smooth the dispersive elec trode s
59. ta may be used as a reference for subsequent tests and should be made available to the Hospital Qualified Biomedical Technician con ducting the tests 2 8 In Case of Difficulty 2 8 1 Dispersive Electrode Alarm Trouble with the dispersive electrode is indicated by red illumination of the Dispersive Electrode Status Alarm Indicators Activation attempts will result in an audible fault alarm Replace the dispersive electrode if any patient contact has been lost If a dispersive electrode or A R M alarm is sounded intraoperatively physically confirm prop er dispersive electrode attachment to the patient and confirm that the display falls within the set range 2 8 1 1 Single Dispersive Electrode Alarm If a Single Dispersive Electrode alarm condition occurs confirm that a single dispersive electrode E e 5000 is attached to the ESU Check all dispersive elec trode cable connections and replace the dispersive electrode or cable if necessary 2 8 1 2 Dual Dispersive Electrode Alarm If a Dual Dispersive Electrode alarm condition occurs check the Dual Dispersive Electrode Status Alarm Indicator for clues to the problem a If only the Dual Dispersive Electrode Status Alarm Indicator flashes red the resistance is too high This can be caused by inappropri ate choice of a site for the dispersive elec trode a broken cable or poor connections to the ESU b If both the Single and Dual Dispersive Electrode Status
60. tage Inside Refer servicing to qualified person nel Serial Interface Connector Ss E D Volume control Bipolar Activation tone Volume control Activation tone Volume increase decrease oS c UL us Medical Electrical Equipment With respect to electric shock fire and mechanical hazards only in accordance with UL2601 1 CAN CSA C22 2 NO 601 1 380X 1 13 507 s000 1 4 Output Characteristic Curves Figure 1 1 illustrates output power delivered to rated load for all available modes Figure 1 2 illustrates the maximum peak voltage available at a given power setting and output mode Section 1 2 specifies rated loads and maximum power for each mode while figures 1 3 1 11 illustrate output power delivered to a range of load resistances for each mode 300 250 200 150 100 50 00 50 100 150 200 250 300 Displayed Setting Power Output Watts to Rated Load Figure 1 1 Output Power vs Power Setting 9000 4000 3000 2000 1000 Output Voltage Peak 0 100 200 300 Power Setting Figure 1 2 Display vs Open Circuit Peak Voltage 1 14 Output Power Watts Output Power Watts 350 0 1 300 0 250 0 200 0 150 0 100 0 50 0 0 0 250 0 200 0 150 0 100 0 50 0 0 0 SYSTEM 5000 300 0 500 1000 1500 2000 Load Resistance Ohms Figure 1 3 Load Regulation Monopolar Pure Cut
61. the quality of connection between the ESU dispersive electrode deteriorates as a result and the single dispersive electrode deteriorates the Dual Dispersive Electrode Status Alarm to a level that is unacceptable this STATUS Indicator gives a relative measure of contact INDICATOR will flash red and an alarm will quality as the procedure progresses sound If the contact quality deteriorates to a level 3 GENERAL MODE INDICATOR This that is unacceptable all BARGRAPH seg default mode illuminates when no Specialty ments will be extinguished the STATUS modes are selected INDICATOR will flash red and an alarm will 4 ELUIDS SPECIALTY MODE sound INDICATOR Illuminates when Fluids 2 SINGLE DISPERSIVE ELECTRODE Specialty Mode is selected STATUS ALARM INDICATOR Indicates 5 LAP SPECIALTY MODE INDICATOR the status of a single dispersive electrode when Illuminates when Lap Specialty Mode is the single dispersive electrode is connected to selected the ESU This STATUS INDICATOR will flash red prior to connection of any dispersive electrode This STATUS INDICATOR will 6 PROGRAM INDICATOR Indicates the selected program illuminate steady green after a single disper 7 SPECIALTY MODE SCROLL KEY sive electrode is acceptably connected to the Pressing this key will scroll between General ESU mode Fluids mode and Lap mode WARNING 8 PROGRAM SELECT SCROLL KEY Pressing this key will scroll between the stored THE SINGLE DISPERSIVE ELECTR
62. uipment Verify proper operation prior to ESU use 1 1 2 Cautions For Patient Preparation Electrosurgery should NEVER be performed in the presence of flammable anesthetics flammable prep solutions or drapes oxidiz ing gases such as Nitrous Oxide N20 or in oxygen enriched environments The risk of igniting flammable gases or other materials is inherent in electrosurgery and cannot be elim inated by device design Precautions must be taken to restrict flammable materials and substances from the electrosurgical site They may be present in the form of an anesthetic life support skin preparation agent produced by natural processes within body cavities or originate in surgical drapes tracheal tubes or other materials There is a 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 fre quency surgical equipment is used Due to the danger of ignition of endogenous gases the bowel should be purged and filled with nonflammable gas prior to abdominal surgery To avoid the risk of tracheal fires never use electrosurgery to enter the trachea during tra cheotomy procedures The System 5000 mobile pedestal is made of nonconductive plastic that can hold a static charge It should not be used in a flammable environment as described above Only non flammable agents should be used for cl
63. up convenience Automatic programming restores the ESU to the last settings used Remote Power Control PC allows power set ting changes using standard hand controlled pencils Independent power setting available for all modes Ability to change power settings from the con trol panel while the ESU is activated Two handswitched receptacles and a separate footswitched receptacle enable multiple acces sory connections Simultaneous activation in non contact monopolar coagulation modes Channeled accessory receptacles direct plugs into position making attachments less cum bersome Illuminated receptacles for greater visibility Integrated operating room control system capability Integrated interface for activation of smoke evacuators and similar devices 1 1 Cautions This equipment in conjunction with connected accessories is intended to produce high frequency electrical energy for the controlled destruction of tissue d a Safe and effective electrosurgery is dependent not only on equipment design but also on factors under 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 comply with the rel evant regulatory standards for your location and meet the requirements of Section 1 2
64. urface with hand to ensure electrode contact to patient skin Replace the dispersive electrode if necessary Simultaneous activation can be used in both Standard and Spray monopolar coagulation modes Caution should be used as the output from either active electrode may change as a result of activation of a second output or end ing activation of an output Power sharing is unlikely to be equal because of differences in electrode to tissue distance and other factors This unequal power sharing can be enough to stop power delivery to one electrode if the second electrode is close to tissue and the first electrode is somewhat above the tissue The motion or deactivation of one electrode can cause the other electrode to start delivering power when it had been too far away from tissue to arc before the first electrode change Simultaneous activation can also increase leakage currents which can be hazardous to the patient It is recommended that a second electrosurgical generator be used when it is necessary to perform simultaneous operation The cables to the surgical electrodes active bipolar or dispersive electrodes should be positioned in such a way that contact with the patient or other leads is avoided Confirm the desired specialty mode is selected prior to use to ensure output characteristics are suitable for the intended procedure Confirm the desired bipolar mode is selected prior to use to ensure output characteristics
65. w The customer or the end user of the System 5000 Electrosurgical Unit should assure that it is used in such an environment Immunity Test IEC60601 test Compliance Electromagnetic environment level level guidance Electromagnetic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short inter ruptions and voltage variations on power sup ply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines X kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 sec Floors should be wood concrete or ceramic tile If floors are covered with synthetic mate rial the relative humidity should be at least 30 Mains power quality should be that of a typi cal commercial or hospital environment Mains power quality should be that of a typi cal commercial o
66. y needs of the modern operating room by providing Four monopolar cutting modes Pure Blend 1 Blend 2 and Blend 3 Three monopolar coagulation modes Spray Standard and Pinpoint Two bipolar modes Micro and Macro Two specialty modes and a general surgery mode General Mode provides full power perfor mance for open surgical procedures Fluids Specialty Mode provides immediate energy delivery for procedures performed in a fluid medium Laparoscopic Specialty Mode provides optimal safety by limiting output voltage and minimizing the potential harmful effects of capacitive coupling Pulse Cut Mode provides precise modulated energy delivery for critical dissection Pulse Coagulation Mode provides a modulated waveform for unsurpassed precision and con trol Radio Frequency RE isolated and indepen dent outputs The proven Automatic Return Monitor A R M contact quality monitoring sys tem Continuous microprocessor safety monitoring Features include Dynamic Response Technology delivers opti mal clinical effects in all operational modes through the continuous synchronization of current and voltage Bipolar Output Meter provides visual and audible feedback to surgeon during tubal liga tions vasectomies and other procedures ReadiPlug universal accessory receptacle eliminates the need for foot controlled adapt ers Nine programmable memory settings provide set

60-8016-ENG REV N.indd - Frank`s Hospital Workshop

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