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AEM®Monitor

1. iii Symbol Deflnilloris vii Accessories Instructions for A 1 1 Introduction Unpacking your System et diim deba ante 1 1 Active Electrode Monlltoring sito e tones e 1 2 Moriopolar S rg rV uuu 1 2 Bipolar Surg ly u aa h qaqa quas sassa asa 1 2 2 Controls Indicators and Receptacles Front 2 1 Hoar Paoli nuansa khu undue atio tats 2 3 3 Setup and Tests Setup of the AEM Monitoring System Monopolar 3 1 Checking the AEM Monitoring System Monopolar 3 3 Setup of the End Point Monitoring System Bipolar 3 7 Checking the End Point Monitoring System Bipolar 3 8 Mechanical E ver eee 3 9 Electrical Inspection eoe een ERU tas ERR RENE E etic 3 9 Me kit um E HE RR 3 9 Storing the AEM Monitor itte utet Pei 3 10 4 Troubleshooting a 4 1 5 Principles of Operation Theory of Operation AEM Monopolar 5 1 Ci
2. 7 6 Compatible cO me dene ree iet RED 7 10 8 Replacement Procedures 2 1 8 1 9 Repair Policy 8 Procedure Obtaining a Return Authorization Number 9 1 Returning the Monitor for Service r 9 1 9 1 shipping the te Ra 9 2 DEMICE P 9 2 Limited Warranty Prts 9 3 10 Service u uuu uuu a 10 1 Service Center Encision Inc 6797 Winchester Circle Boulder Colorado 80301 3513 USA 303 444 2600 www encision com ii 02087 001 Foreword Foreword This manual and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed This manual is intended as a guide for servicing the AEM Monitor including its setup and operation It is not intended to be a general reference about the use of electrosurgery either in general application or in laparoscopic procedures Indications for Use The Encision AEM Monitoring System is an accessory for use with electrosurgical generators and electrodes that is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive couplin
3. to the return of each defective product for repair or replacement by ENCISION Upon such request ENCISION shall provide the address of the facility to which such product must be returned together with Return Material Authorization RMA tracer number ENCISION may at its sole option employ new or used parts for products to make such repair or replacement Stored Data ENCISION shall not be liable for any loss or damage to any data stored in any product including without limitation any data loss or damage resulting from any malfunction or defect or any loss or damage resulting from any inspection repair refurbishment reconditioning or testing of the product or incurred in connection with transportation of the product to ENCISION or ENCISION s authorized repair center Technical Assistance ENCISION s warranty shall not be enlarged and no obligation or liability shall arise out of ENCISION s rendering of technical advice or assistance in connection with the products sold hereunder Limitation of Liability TO THE EXTENT ALLOWABLE BY APPLICABLE LAW IN NO EVENT SHALL ENCISION BE LIABLE FOR ANY SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING OUT OF THE SALE INSTALLATION USE OPERATION SERVICE OR REPAIR OF ANY PRODUCT WHETHER BASED ON BREACH OF WARRANTY OR CONTRACT STRICT LIABILITY NEGLIGENCE OR OTHER WISE WHERETH OR NOT ENCISION SHALL HAVE BEEN ADVISED AS TO THE POSSIBILITY OR REASON FOR ANY SU
4. BIPOLAR ACCESSORY jacks two arranged horizontally on front panel Two standard banana jacks Provided for connecting to the bipolar accessory There is no preferred polarity REMOTE DISPLAY jack mounted on rear panel Four pin male XLR series panel receptacle Provided for connecting to the remote display cable Attaching the cable activates the remote display and deactivates the front panel display of bipolar current Power Receptacle mounted on rear panel UL IEC type receptacle containing two 0 5 Amp 250V fast blow 5 x 20 mm fuses one for each side of the line Power Cord attached to power receptacle A 15 4 6 m long 16 3 power cord with a three prong hospital grade plug 115V AC 02087 001 Technical Specifications Electrical Characteristics Input Power Requirements 115 Volt 115 V nominal 105 130 Volts 47 63 Hz Normal current drain 0 2 Maximum current Chassis Source Leakage Current 100 uA maximum Patient Leakage Current Source or sink leakage current is 10 nA maximum Dimensions and Weight External Dimensions 13 0 in 33 0 cm wide x 20 1 in 51 cm long x 3 in 7 6 cm high does not include feet Feet raise chassis 0 5 in 1 3 cm Weight 14 0 lbs 6 35kg Environmental Characteristics Operating Temperature 50 to 1220 10 to 50 C Storage and Transport Temperature 13 to 158 F 25 to 70 C Operating Storage and Transport Humidity 5 to 95 relat
5. ETC IF THIS IS NOT POSSIBLE DURING CERTAIN PROCEDURES E G THOSE IN WHICH NONINSULATED HEAD FRAMES ARE USED USE EXTREME CAUTION TO MAXIMIZE PATIENT SAFETY e USE THE LOWEST POWER SETTING THAT ACHIEVES THE DESIRED EFFECT PLACE THE PATIENT RETURN ELECTRODE AS CLOSE TO THE SURGICAL SITE AS POSSIBLE PLACE DRY GAUZE BETWEEN THE PATIENT AND THE GROUNDED OBJECT IF POSSIBLE CONTINUALLY MONITOR THE CONTACT POINT S Active Accessories and AEM Monitor THESE DEVICES HAVE BEEN SPECIFICALLY DESIGNED FOR USE IN ELECTROSURGERY DO NOT USE FOR OTHER PROCEDURES DO NOT WRAP ACCESSORY CORDS AROUND METAL OBJECTS WRAPPING CORDS AROUND METAL OBJECTS MAY INDUCE CURRENTS THAT COULD LEAD TO SHOCKS FIRES OR INJURY THE ELECTRODE TIP MAY REMAIN HOT ENOUGH TO CAUSE BURNS AFTER THE ELECTROSURGICAL CURRENT IS DEACTIVATED WHEN NOT IN USE PLACE ACCESSORIES IN A CLEAN DRY NONCONDUCTIVE AND HIGHLY VISIBLE AREA NOT TOUCHING THE PATIENT INADVERTENT CONTACT WITH THE PATIENT MAY RESULT IN BURNS INADVERTENT ACTIVATION OR MOVEMENT OF THE ACTIVATED ELECTRODE TIP OUTSIDE THE FIELD OF VISION MAY RESULT IN INJURY TO THE PATIENT USE THESE INSTRUMENTS ONLY UNDER CONDITIONS THAT ASSURE ADEQUATE VISUALIZATION LOCALIZED BURNS TO THE PATIENT OR PHYSICIAN MAY COME FROM ELECTRICAL CURRENTS CARRIED THROUGH CONDUCTIVE OBJECTS SUCH AS CANNULAS OR SCOPES ELECTRICAL CURRENT MAY BE GENERATED IN CONDUCTIVE OBJECTS BY DIRECT CONTACT WITH THE ACTIVE ACCE
6. Plug the bipolar jumper cord into the receptacle marked Bipolar Generator on the left front panel of the AEM Monitor and the other end into the bipolar receptacle of the electrosurgical generator 2 Attach bipolar jumper cord retainer bracket according to accompanying installation instructions Document 00476 ELECTRIC SHOCK HAZARD ACCESSIBLE PINS OF THE JUMPER CORD MAY LEAD TO SHOCK OR BURNS TO SURGICAL PERSONNEL IF THE GENERATOR BIPOLAR OUTPUT IS ACTIVATED WHILE THE BIPOLAR JUMPER CORD IS PLUGGED INTO THE GENERATOR RECEPTACLE BUT THE OTHER END IS NOT PLUGGED INTO THE AEM MONITOR RECEPTACLE ELECTRIC SHOCK HAZARD DO NOT CONNECT WET ACCESSORIES TO THE GENERATOR ENSURE THAT ACCESSORIES AND ADAPTERS ARE CORRECTLY CONNECTED AND THAT NO METAL IS EXPOSED INSPECT ACCESSORIES AND CORDS FOR BREAKS CRACKS NICKS OR OTHER DAMAGE BEFORE EVERY USE VERIFY THAT END OF LIFE INDICATORS ARE NOT PRESENT IF ANY OF THESE ARE PRESENT DO NOT USE FAILURE TO OBSERVE THIS PRECAUTION MAY RESULT IN INJURY OR ELECTRICAL SHOCK TO THE PATIENT OR OPERATING PERSONNEL 3 Prepare the surgical instrument to be used for the procedure Connect one end of the bipolar instrument cord to the instrument and the other end into the receptacle marked Bipolar Accessory on the left front panel of the AEM Monitor 4 Adjust the volume of the clicks that indicate bipolar current flow The Volume Control switch is located on the left rear panel of the AEM Monitor 6
7. When the diode is not conducting the transistor is not conducting causing the output voltage to be near ground These transitions are briefly delayed to the logic input buffer U6 7 by R74 and C34 The buffer output drives the Programmable Logic Device PLD logic input U4 5 R74 and C34 also serve to suppress the effects of RF pickup as well as R72 49 and 5 The conductivity monitors described above are isolated from the circuit ground used by the other circuits Consequently the conductivity monitors must be powered by an isolated power supply The primary side of transformer T1 is driven by a FET Q1 whose input is connected to the system s 8 kHz square wave clock The output appearing at the secondary winding of T1 is rectified by diode D2 filtered by C1 and C4 and regulated to approximately 4 volts by Zener D1 ESU Keyed Detector The ESU Keyed detector picks up the electromagnetic signal generated around the ESU when it is active and produces a logic level signal for the logic circuit The electromagnetic field is sensed by a coil imbedded in the coil plate mounted on top of the case The coil voltage is amplified by U4 full wave rectified by U3 filtered U2A and converted to logic signal ESU Keyed by comparator U1B Logic The Logic Circuitry controls the functioning of the unit in response to sensors measuring external parameters such as AEM Cord connected Patient Electrode connected Active electrode short
8. io 02087 001 Controls Indicators and Receptacles 2 Controls Indicators and Receptacles The AEM Monitor front and rear panel features are illustrated and described in this section Front Panel 01 2 3 4 5 6 4 7 8 9 10 11 RF AMPERES BIPOLAR I GENERATOR BIPOLAR ENDPOINT MONITOR AEM CORD INSULATION N RETURN ELECTRODE Monitor AEM CORD RETURN ELECTRODE INSULATION READY 02087 001 m POWER Green Indicator when power is supplied The power switch is located on the side of the unit AEM CORD Amber Indicator Illuminates if the AEM Cord is not connected to the Monitor or if the cord is not plugged into the AEM instrument RETURN ELECTRODE Amber Indicator Illuminates if the return electrode is of the wrong type or is not connected INSULATION Red Indicator Illuminates in the event of an internal insulation failure of an AEM Instrument READY Green Indicator Illuminates if all conditions have been met for AEM Monitoring System operation 2 1 Controls Indicators and Receptacles ar2 3 4 5 6 7 8 9 10 11 RF AMPERES BIPOLAR ENDPOINT MONITOR 5 BIPOLAR ACCESSORY 2 2 AEM CORD Receptacle The AEM Cord Adapter connects to this receptacle Green Inhibit Adapter An adapter that connects to the ESU return electrode receptacle and has a receptac
9. ohms to the 15V supply end of C47 and pin U2 16 The voltage should be gt 14V initially and 1V when pins 1 amp 2 are shorted If this does not happen return the unit for repair If the above steps have failed return the unit for repair Must use a dual pad return electrode Verify that the return electrode connector has a pin projecting from the end Remove the return electrode connector from the adapter and reinsert fully into the adapter If the Return Electrode indicator goes out unit is OK If not wiggle the return electrode connector in the direction of smallest dimension If the indicator goes out only momentarily replace the adapter assembly Remove the cover and short pins 3 amp 4 of J1 If the indicator goes out replace the adapter assembly Remove the front panel connection to the ESM board at J2 and connect a voltmeter shunted with 1K ohms to the 15V supply end of C47 and pin U2 15 The voltage should be gt 14 initially and 1V when pins 3 amp 4 are shorted If this does not happen return the unit for repair If the above steps have failed return the unit for repair 4 3 Troubleshooting Situation Electrosurgical generator remains in alarm state Both Return Electrode and AEM Cord indicators are on Electrosurgical generator remains in alarm state Ready indicator is on and all fault indicators are off 4 4 Possible Cause See possible causes for
10. the AEM cord end to an AEM instrument put on an alligator clip that shorts both pins Set the electrosurgical generator to 20 watts coag The system should turn on with no faults indicated Activate the coag output and carefully move the pencil s blade to the alligator clip until an arc is seen If the AEM Monitor fails to light the Insulation indicator and deactivate the electrosurgical generator return the unit for repair Same setup as above Hold the pencil s blade against the alligator clip and then activate the electrosurgical generator If the AEM Monitor fails to light the Insulation indicator and deactivate the electrosurgical generator return the unit for repair Replace power supply DO NOT REPLACE FUSES 02087 001 End Point Monitor Bipolar Situation When the power is turned ON all indicators including the power ON are not on and no beeps are heard 02087 001 Possible Cause Disconnected power cord faulty wall receptacle or malfunctioning power cord Fuse drawer is open or fuses are blown Malfunctioning power entry module or connections Malfunctioning power switch Malfunctioning AC Power Cable in chassis Malfunctioning power supply Internal cables loose disconnected or faulty Malfunctioning ESM Display Board Troubleshooting Recommended Action Check the power cord connections Monitor and wall receptacle Connect the power cord to a functional w
11. DISCONNECT THE POWER CORD BEFORE REPLACING PARTS Caution THE AEM MONITOR CONTAINS ELECTROSTATIC SENSITIVE COMPONENTS WHEN REPAIRING A UNIT WORK AT A STATIC CONTROL WORKSTATION AND WEAR A GROUNDING STRAP HANDLE CIRCUIT BOARDS BY THEIR NONCONDUCTIVE EDGES USE AN ANTISTATIC CONTAINER FOR TRANSPORT OF REPLACEMENT PARTS Notice BEFORE ANY OF THE FOLLOWING CAN BE PERFORMED THE COVER MUST BE REMOVED Removal of Cover 1 Turn off the AEM Monitor and disconnect the power cord from the wall receptacle 2 Remove the six screws that secure the cover to the chassis Save for reinstallation 3 Lift the cover off the chassis Save for reinstallation D C Power Cable Replacement 1 Remove the D C power cable connectors from the ESM Main Board s J4 and the three output power supply s J2 2 Install anew D C power cable by connecting it to the ESM Main Board s J4 and the three output power supply s J2 I F Cable Replacement 1 Remove the I F Cable connectors from the ESM Main Board s J5 and the EPM Main Board s J4 2 Install the new I F Cable by connecting it to the ESM Main Board s J5 and the EPM Main Board s J4 02087 001 8 1 8 2 Three Output Power Supply 8 9 Remove the screws in the upper right and lower left corners of the board Save for reinstallation Disconnect all cable connections to the power supply J1 and J2 Pull up at each of the
12. OF A DUAL PAD RETURN ELECTRODE AND AN ELECTROSURGICAL UNIT EQUIPPED WITH CONTACT QUALITY MONITORING PATIENT SAFETY TECHNOLOGY READ AND REVIEW ALL INSTRUCTIONS PROVIDED BY THE MANUFACTURER OF THE DUAL PAD RETURN ELECTRODE YOU WILL BE USING READ AND REVIEW ALL INSTRUCTIONS PROVIDED BY THE MANUFACTURER OF THE AEM ACCESSORIES YOU WILL BE USING ONLY AN AEM INSTRUMENT PROVIDES ACTIVE ELECTRODE MONITORING OTHER CONDUCTIVE OBJECTS AT OR NEAR THE SURGICAL SITE ARE NOT PROTECTED DO NOT TOUCH THOSE OBJECTS WITH THE ACTIVE INSTRUMENT 4 Connect an AEM cord with an AEM instrument to the AEM CORD ADAPTER at the ESU 6 2 02087 001 Surgical Use Checking the AEM Monitoring System The following is a quick test of the AEM Monitoring System A failure of this test should be resolved before using the system Please refer to the Troubleshooting Section to establish the cause of any failure 5 Verify that the setup fault indicators are off and the READY indicator illuminates on the AEM Monitor Turn on the electrosurgical generator and enable its contact quality monitoring system It should be in its normal operational state Disconnect the AEM Cord from the AEM CORD ADAPTER at the ESU Verify that the following occurs The AEM Monitor AEM CORD indicator illuminates The AEM Monitor READY indicator extinguishes The contact quality monitoring system on the electrosurgical generator alarms Reconnect the AEM Cord to the A
13. THE EVENT OF DIRECT ELECTRODE TIP CONTACT TO THE CANNULA REFER TO THE CANNULA MANUFACTURER S INSTRUCTIONS BEFORE INSERTING THE ELECTRODE INTO THE CANNULA TO AVOID DAMAGING THE ELECTRODE OR INJURING THE PATIENT INSERT AND WITHDRAW THEM CAREFULLY INSPECT CORDS FOR BREAKS CRACKS NICKS OR OTHER DAMAGE BEFORE EVERY USE ENSURE THAT END OF LIFE INDICATORS ARE NOT PRESENT ANY OF THESE ARE PRESENT DO NOT USE FAILURE TO OBSERVE THIS PRECAUTION MAY RESULT IN INJURY OR ELECTRICAL SHOCK TO THE PATIENT OR OPERATING PERSONNEL 6 6 02087 001 Surgical Use Warnings continued DAMAGED EXTERNAL INSULATION ON INSTRUMENTS AND INCORRECT SETUP OF THE AEM MONITOR MAY RESULT IN A RISK OF UNINTENDED PATIENT BURN DO NOT USE PRODUCT HAVING DAMAGED INSULATION Caution READ THE INSTRUCTIONS WARNINGS AND CAUTIONS PROVIDED WITH THE AEM MONITORING SYSTEM ACCESSORIES BEFORE USING THEIR SPECIFIC INSTRUCTIONS ARE NOT INCLUDED IN THIS MANUAL LIMIT POWER SETTING TO 80 WATTS OR LOWER 60 WATTS FOR THE CONMED ASPEN EXCALIBUR SPRAY MODE HIGHER SETTINGS MAY RESULT IN SPURIOUS INSULATION FAILURE ALARMS AND OR INSULATION BREAKDOWN REFER TO INSTRUMENT INSTRUCTIONS FOR USE FOR OTHER LIMITS DAMAGED INTERNAL INSULATION OF THE INSTRUMENT OR LOSS OF SHIELD CONTINUITY MAY CAUSE ESU RETURN PAD ALARMS TRIGGERED BY THE AEM MONITOR S FAULT INDICATORS FOR MAXIMUM PATIENT SAFETY DISCONTINUE USE OF THE INSTRUMENT IF THIS OCCURS A SINGULAR AEM INS
14. a temperature that is outside its normal operating range of 50 to 122 F 10 to 50 C allow one hour for the monitor to reach room temperature before use Service Center Encision Inc 6797 Winchester Circle Boulder Colorado 80301 3513 USA 303 444 2600 02087 001 4 Troubleshooting Troubleshooting This troubleshooting guide gives instructions for identifying and correcting malfunctions and responding to alarms Refer to Section 7 if a part needs to be replaced and Figure 1 in Section 7 page 5 for location of connectors and pins Caution REFER ALL SERVICING TO QUALIFIED PERSONNEL AEM Monitor Monopolar Situation The Power On Self Test function POST did not take place when power was turned ON All indicators including the power ON are not on and no beeps are heard 02087 001 Possible Cause Disconnected power cord faulty wall receptacle or faulty power cord Fuse drawer is open or fuses are blown Malfunctioning power entry module or connections Malfunctioning power switch Malfunctioning AC Power cable in chassis Malfunctioning power supply Internal cables loose disconnected or malfunctioning Recommended Action Check the power cord connections monitor and wall receptacle Connect the power cord to a functional wall receptacle necessary replace the power cord Open the fuse drawer Check the fuses and replace if necessary with 0 5 A 5 X 20 mm fuse Instal
15. or arcing to Electroshield The responses include activating front panel indicators audible indications and the control relay The Logic Circuitry is shown in the schematic ESM Logic drawing The logic is paced by the system clock whose frequency is controlled to approximately 8 2 kHz by precision RC components R38 R39 C27 and a clock IC U7 This primary frequency is counted down by a counter chain in U7 to form square wave outputs of 512 Hz 2 Hz and 0 5 Hz These outputs applied to logic inputs of the PLD U4 at pins 8 9 and 10 respectively The Power On Detector generates a 50 ms positive logic pulse PON when the power has just been turned on after being off for more than 5 seconds When the system power is off C32 is discharged When the system power is turned on the juncture of C32 and R37 will be at a positive voltage nearly equal to the 5V supply this causes the output of U6A to go positive Then C32 will charge to the supply voltage through R37 When the voltage across C32 becomes large enough the buffer amplifier U6A turns off and its output goes to zero Resistors R36 and R35 cause positive feedback to be applied so that the transitions will be 02087 001 Principles of Operation quick Diode D5 prevents the input to U6A from being damaged by negative input caused when the power is turned off and C55 is intended to eliminate RF interference The functional logic is determined by the PLD in U4 GAL6
16. remaining corners of the board to free it from the standoff Apply force as close as possible to standoff to prevent breaking the corner of the board Put the power supply into an antistatic bag and return to the Encision Service Center Remove the new power supply board from the antistatic bag and orient it over the standoffs so that J1 is near the rear panel Starting in the upper left corner press the board onto the standoff until it snaps into place Apply force as close as possible to standoff to prevent breaking the corner of the board Press the board onto the lower right standoff until it snaps into place Apply force as close as possible to standoff to prevent breaking the corner of the board Reinstall the screws in the upper right and lower left corners of the board Reconnect ground lug to screw in lower left corner 10 Check the power supply s output voltages at power supply s J2 Pins 2 and 4 are ground Pin 1 15 0 1V Pin 3 45 27 05V Pin 5 15 0 1V If any voltage is incorrect adjust or replace the power supply 11 Reconnect all cable connections to the power supply J1 and J2 Front Panel Replacement 1 Disconnect the front panel cables connected to J1 and J2 on the EPM Main Board Disconnect the front panel cables connected to J1 and J2 on the ESM Main Board Remove the nuts and lock washers located at the left and right ends of the front panel shown by arrows 1 amp 2
17. the normal level Do not return any instrument giving an alert to the tray but instead discard it or isolate it for further study Record the type of AEM Monitor alert given Insulation Fault or AEM Cord Note In the case of cord alert the fault may be in the cord itself the AEM Cord Adapter or in the cord s contact with the instrument Checking the Monitoring System Monopolar The following is a quick test of the AEM Monitoring System A failure on any of the following tests should be resolved before use of the system Please refer to the troubleshooting section to establish the cause of any failure Encision recommends that this test be performed once per year Power On Self Test Function POST 1 POST is activated when the power is switched on after being off for at least 30 seconds In POST each of the monopolar visual indicators is illuminated for 6 seconds and two beeps are heard 02087 001 3 3 Setup and Tests AEM Cord Connect and Disconnect Notice THIS TEST REQUIRES THAT THE ELECTROSURGICAL GENERATOR MEET THE CONTACT RESISTANCE CRITERIA REFER TO THE INSTRUCTIONS FOR THE ELECTROSURGICAL GENERATOR THE RETURN ELECTRODE USED FOR THE TESTING MUST SATISFY THE ELECTROSURGICAL GENERATOR S CONTACT QUALITY MONITOR EITHER PLACE THE PAD ON THE SKIN OR ADD RESISTANCE TYPICALLY 15 OHMS BETWEEN THE RETURN ELECTRODE WIRES AT THE PANEL 2 10 11 Connect the AEM Monitor inhibit adapter into the return elec
18. the visual indicators illuminate and two beeps are heard If this is not the case please refer to the Troubleshooting section 02087 001 6 1 Surgical Use Monopolar Surgery Active electrode monitoring is intended to control stray monopolar energy caused by insulation failure and capacitive coupling on the shaft of the AEM instrument Caution THE ACTIVE ELECTRODE MONITORING SYSTEM TECHNOLOGY IS DESIGNED TO SAFELY DELIVER ELECTROSURGICAL ENERGY AND TO PREVENT INJURY CAUSED BY INSULATION FAILURE AND CAPACITIVE COUPLING THE AEM MONITOR IS NOT INTENDED TO TEST FOR INSULATION DAMAGE ON LAPAROSCOPIC INSTRUMENTS DO NOT ATTEMPT TO USE THIS SYSTEM AS AN INSTRUMENT INSPECTION TOOL GOOD OPERATING ROOM PRACTICE SUGGESTS THAT CONNECTIONS OF ACCESSORIES ELECTROSURGICAL GENERATORS BE MADE ONLY WHILE GENERATOR 15 OFF OR STANDBY Power On Self Test Function POST POST is activated when the power is switched on after being off for at least 30 seconds In POST each of the monopolar visual indicators illuminates for six seconds and two beeps are heard Setup 1 Connect the AEM Monitor inhibit adapter to the return receptacle on the electrosurgical generator 2 Apply the return electrode to the patient and plug it into the inhibit adapter already mounted into the electrosurgical unit s return electrode receptacle 3 Plug AEM Cord Adapter into footswitch output of ESU Caution AEM WILL NOT FUNCTION WITHOUT THE USE
19. 001 Logic input signals are buffered by the amplifiers in 06 to ensure proper logic levels The logic output signals are buffered by the amplifiers in 02 to supply sufficient sink current as required by the output indicators The functional logic implemented by the PLD is described below The PON signal causes a reset of the time counter and all internal counters and starts the Power On System Test POST cycle A six bit counter implemented with buried flip flops counts the 2 Hz clock input and is used to time the various actions Each the indicators is driven by a separate PLD output During the POST cycle all indicators are turned on to test the indicator circuitry The AEM Cord indicator is controlled by the CORDS signal which indicates whether the cord is in place The Return Electrode indicator is controlled by the REF signal which indicates whether the return electrode connector is plugged into the adapter The Insulation indicator illuminates when either the SHORT or ARC signals are present and remains on for 30 seconds after activation The SHORT signal indicates that the current being drained by the shield exceeds a predetermined threshold and the ARC signal indicates that there is an arc to the shield In addition the meaning of the AEM Cord and Insulation indicators are changed when the unit is in a debug mode This mode is active when the Electroshield cord is in place while the return ele
20. 2 AHF Operation in Spray Coag mode limited to 70W or less Mounting Tray Installation Kit 03184 000 amp Universal Adapter ES9015 with Extender Adapter ES9008 required Contact Encision Tech Support for details System 7550 Return Electrodes The AEM Monitoring System requires a dual area return electrode The following products are designed to be used with electrosurgical generators having contact quality monitoring systems Aspen 3M NDM Valleylab and others 710 02087 001 Technical Specifications Notice ALL ELECTROSURGICAL GENERATORS ESUS MUST HAVE CONTACT QUALITY MONITORING CIRCUIT FOR RETURN ELECTRODES CORD ADAPTER ES9015 IS FOR HAND AND FOOT CONTROLLED INSTRUMENTS ES9005 ES9005A IS FOR FOOT CONTROLLED ONLY Active Electrodes Notice SUCTION IRRIGATION ELECTRODES ARE RATED FOR USE WITH MAXIMUM ESU OUTPUT OF 60W The AEM Monitor must be used with instruments with patented AEM technology manufactured by for Encision Inc or licensed by Encision Inc 02087 001 7 11 Technical Specifications This page intentionally left blank 7 12 02087 001 Replacement Procedures 8 Replacement Procedures This section gives instructions on replacing a specific part of your AEM Monitor For your reference a physical layout and electrical interconnect diagram that illustrates the placement of parts and all cable connections is provided on Page 10 2 ELECTRIC SHOCK HAZARD
21. 4 02087 001 Surgical Use Caution THE END POINT MONITOR ACTIVATION CLICKS WHEN AN ACCESSORY IS DO NOT TURN THE VOLUME DOWN TO WHERE THE CLICKING SOUND IS BELOW AN AUDIBLE LEVEL 5 Adjust the bipolar output mode and power setting on the generator Caution CONFIRM PROPER POWER SETTINGS BEFORE PROCEEDING WITH SURGERY USE THE LOWEST POWER SETTING POSSIBLE FOR THE MINIMUM TIME NECESSARY TO ACHIEVE THE DESIRED SURGICAL EFFECT 6 After successful completion of these steps the bipolar activation tone on the bipolar generator sounds upon keying and the system is ready for operation In operation the bipolar indicator bar illuminates indicating the current which is flowing between tines Caution DO NOT ATTEMPT TO CONNECT OR DISCONNECT ANY CABLE DURING POWER ACTIVATION Checking the End Point Monitoring System The response of the End Point Monitor may be tested during use 1 Set generator at 5 to 10 watts depending upon the generator characteristics 2 Touch the tines of the instrument together There should be a smooth registration of the current on the bar graph scale The clicking will also change its rate to correspond with the current When performing this check for the first time with a particular bipolar generator start at a low setting then increase the setting to obtain a mid scale deflection of the bar graph This test ensures that all three components cord bipolar instrument and End Point Moni
22. CH POTENTIAL LOSS OR DAMAGE DIRECT DAMAGES SHALL BE STRICTLY LIMITED TO THE COST TO BUYER OF THE PRODUCTS SOLD OR PROVIDED TO BUYER NOT WITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY 9 4 02087 001 10 Service Parts For 2 2 02087 001 Service Parts Replacement parts for the AEM Monitor are listed in this section If a part is not listed it is not available A C Power Cord 115V D C Power Cable Front Panel Fuse 5 x 20 mm 0 5 Amp 115V I F Cable Inhibit Adapter Assy 21 w o Extension Power Supply Three Output Shield Connector Assembly Bipolar Cord 115v Inhibit Adapter Extension for use with Conmed Aspen System 2500 5000 Conmed Aspen Sabre 2400 Conmed Aspen System 2450 00492 000 00483 001 00638 004 01331 000 00484 000 00652 002 01347 000 01452 000 ES9004 ES9007 10 1 Service Parts ON OFF CABLE POWER ENTRY MODULE THREE OUTPUT POWER SUPPLY END POINT MONITOR EPM MAIN BOARD Ji J2 0 CABLE 6 ELECTROSHIELD MONITOR ESM MAIN BOARD 1 s FRONT PANEL ASSEMBLY 10 2 02087 001
23. DED TO TEST FOR INSULATION DAMAGE ON LAPAROSCOPIC INSTRUMENTS DO NOT ATTEMPT TO USE THIS SYSTEM AS AN INSTRUMENT INSPECTION TOOL The AEM Monitor consists of two distinct functions gt Active Electrode Monitoring Intended to control stray monopolar energy caused by insulation failure and capacitive coupling in surgical instruments on the shaft of the instrument gt End Point Monitoring Intended to aid the surgeon in determining the end point of bipolar electrosurgical desiccation Unpacking your System Your system is shipped in one carton We suggest that your store this carton so that it will be available if the need for service arises Carefully unpack the carton Check to ensure you received the following parts If any of these parts are missing please contact our service center as soon as possible AEM Monitor Power Cord Setup Card Operator Service Manual Contact Customer Service at 303 444 2600 to arrange for repair or replacement of any parts damaged from shipping 02087 001 1 1 Introduction Active Electrode Monitoring Active electrode monitoring technology can eliminate the risk of stray electrical energy caused by insulation failure and capacitive coupling and thus helps to prevent unintended internal burn injury to the patient AEM instruments direct electrosurgical energy where the surgeon desires while continuously monitoring the current flow to prevent stray electrosurgical energy
24. EM CORD Adapter at the ESU Reset CQM system if necessary Verify that the following occurs The AEM Monitor AEM CORD indicator extinguishes The AEM Monitor READY indicator illuminates The contact quality monitoring system on the electrosurgical generator no longer alarms After successful completion of these steps the system is ready for use If the system does not perform as described do not use until repaired and refer to Section 4 Troubleshooting 02087 001 6 3 Surgical Use Bipolar Surgery End Point Monitoring of the bipolar instrument will assist the surgeon in confirming the end point of bipolar desiccation This information is displayed on the left front panel of your AEM Monitor as an illuminated visual graph and a volume controlled audible indicator If you are using the Encision End Point Monitor Remote Display EMR plug it into the receptacle found on the left rear panel of the AEM Monitor Notice IF YOU ARE USING THE ENCISION END POINT MONITOR REMOTE DISPLAY EMR MOUNT THE DISPLAY NEAR THE TV MONITOR OR AT ANOTHER LOCATION IN THE VIEW OF THE OPERATING ROOM STAFF IF BOTH MONOPOLAR AND BIPOLAR FUNCTIONS ARE BEING USED THE MONOPOLAR INSTRUMENT MUST REMAIN CONNECTED TO AVOID SPURIOUS ALARMS WHEN USING THE ENCISION END POINT MONITOR REMOTE DISPLAY EMR ONLY THE REMOTE ILLUMINATES DURING BIPOLAR CURRENT FLOW THE END POINT MONITOR FRONT PANEL ON THE AEM MONITOR DOES NOT ILLUMINATE 1
25. ENCISIGN AEM Monitor Operator Service Manual II1117 1114 v _ RF AMPERES M M mu 4 BIPOLAR ENDPOINT MONITOR V erum evectnooe SS O v 2 ge Monitor BIPOLAR ACCESSORY CORD with AEM Technology 02087 001 ENCISIGN Operator Service Manual Monitor EM2 A 115v EM2 AHF 115v 02087 001 02087 001 Manufactured by Encision Inc 6797 Winchester Circle Boulder Colorado 80301 3513 Made in USA US Patents 5 312 401 and 5 688 269 Other Patents Pending International Patents Japan Patent 2 509 081 Canada Patent 2 112 817 European Patent Convention 0596909 Australia Patent 667322 Trademark acknowledgments Encision isa registered trademark of Encision Inc AEM isa registered trademark of Encision Inc is a trademark of Covidien Valleylab ARM is a trademark of ConMed Aspen Labs Printed in USA Part Number 02087 001 2011 09 9 2011 Encision Inc All rights reserved ETL LISTED MEDICAL ELECTRICAL CONFORMS TO UL STD 60601 1 Intertek 3181955 Contents Table of Contents Page Foreword Indications for WSC i Conventions Used in This Manual r ii Warnings and Cautions
26. HAZARD CONNECT THE GENERATOR POWER CORD TO A PROPERLY GROUNDED RECEPTACLE DO NOT USE POWER STRIP PLUG ADAPTERS ELECTRIC SHOCK HAZARD ENSURE THAT ALL ACCESSORIES CORDS AND ADAPTERS ARE CORRECTLY CONNECTED AND THAT NO METAL IS EXPOSED ELECTRIC SHOCK HAZARD DO NOT CONNECT A WET POWER CORD TO THE AEM MONITOR OR TO THE WALL RECEPTACLE ELECTRIC SHOCK HAZARD ALWAYS UNPLUG THE AEM MONITOR BEFORE CLEANING 02087 001 iii Foreword General Electrosurgical Hazards ANY ELECTROSURGICAL PROCEDURE IS SAFEST IF MODERATE CONTROL SETTINGS ARE USED ALONG WITH MINIMUM ACTIVATION TIMES PROLONGED ACTIVATIONS WITHOUT THE ELECTRODE IN CONTACT WITH THE TISSUE SHOULD BE AVOIDED CONFIRM PROPER ELECTROSURGICAL POWER SETTING BEFORE PROCEEDING WITH SURGERY USE THE LOWEST POWER SETTING THAT ACHIEVES THE DESIRED SURGICAL EFFECT IN ORDER TO LESSEN THE POSSIBILITY OF CREATING UNINTENDED BURNS ACTIVATE THE ELECTROSURGICAL GENERATOR ONLY WHEN THE ACTIVE ELECTRODE IS NEAR OR TOUCHING THE TARGET TISSUE THE SAFE USE OF MONOPOLAR ELECTROSURGERY REQUIRES PROPER PLACEMENT OF THE PATIENT RETURN ELECTRODE TO AVOID ELECTROSURGICAL BURNS BENEATH THE PATIENT RETURN ELECTRODE FOLLOW ALL DIRECTIONS ON THE PRODUCT PACKAGE FOR PROPER RETURN ELECTRODE PLACEMENT AND USE IN SOME CIRCUMSTANCES POTENTIAL EXISTS FOR ALTERNATE SITE BURNS AT POINTS OF SKIN CONTACT E G BETWEEN THE ARM AND THE SIDE OF THE BODY THIS OCCURS WHEN ELECTROSURGICAL CURRENT SEEKS A PA
27. HE MANUFACTURER OF THE EQUIPMENT OR SYSTEM AS REPLACEMENT PARTS FOR INTERNAL COMPONENTS MAY RESULT IN INCREASED EMISSIONS OR DECREASED IMMUNITY OF THE EQUIPMENT OR SYSTEM AEM MONITOR SHOULD NOT BE USED ADJACENT TO OR STACKED WITH OTHER EQUIPMENT IF ADJACENT OR STACKED USE IS NECESSARY THE EQUIPMENT SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION IN THE CONFIGURATION IN WHICH IT WILL BE USED FOLLOW THE ELECTROSURGERY UNIT MANUFACTURERS INSTRUCTIONS AS FAR AS LOCATING EQUIPMENT WITHIN THE OPERATING ROOM TO DIMINISH OR ELIMINATE RADIO FREQUENCY ELECTRICAL INTERFERENCE WITH OTHER ELECTRONIC EQUIPMENT MEDICAL ELECTRICAL EQUIPMENT NEEDS SPECIAL PRECAUTIONS REGARDING EMC AND NEEDS TO BE INSTALLED AND PUT INTO SERVICE ACCORDING TO THE INFORMATION PROVIDED IN THE ACCOMPANYING DOCUMENTS PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT CAN AFFECT MEDICAL ELECTRICAL EQUIPMENT Symbol Definitions N Caution Power Consult instructions gn for use Ready Type CF equipment 9 with defibrillator protection Return Electrode setup fault J m Catalog Number Serial Number AEM Cord setup fault Manufacturing Date Bipolar Accessory Manufacturer Bipolar Jumper Cord Protective Earth Ground Remote Display Jack 2 Volume Control d O 1 High Low DE 3 2 a 02087 001 vii Foreword This page intentionally left blank viii 02087 001 Accessories Instructions f
28. ND ADAPTERS ARE CORRECTLY CONNECTED AND THAT NO METAL IS EXPOSED 02087 001 3 7 Setup and Tests Caution INSPECT ACCESSORIES AND CORDS FOR BREAKS CRACKS NICKS OR OTHER DAMAGE BEFORE EVERY USE INSURE THAT END OF LIFE INDICATORS ARE NOT PRESENT IF ANY OF THESE ARE PRESENT DO NOT USE FAILURE TO OBSERVE THIS PRECAUTION MAY RESULT IN INJURY OR ELECTRICAL SHOCK TO THE PATIENT OR OPERATING PERSONNEL 2 Prepare the surgical instrument to be used for the procedure Connect one end of the bipolar instrument cord to the instrument and the other end into the Bipolar Accessory receptacle on the left front panel of the AEM Monitor 3 Adjust the volume of the clicks that indicate bipolar current flow The Volume Control switch is located on the left rear panel of the AEM Monitor Caution THE END POINT MONITOR ACTIVATION CLICKS WHEN AN ACCESSORY IS ACTIVE DO NOT TURN THE VOLUME DOWN TO WHERE THE CLICKING SOUND IS BELOW AN AUDIBLE LEVEL 4 Adjust the bipolar output mode and power setting Caution CONFIRM PROPER POWER SETTINGS BEFORE PROCEEDING WITH SURGERY USE THE LOWEST POWER SETTING POSSIBLE FOR THE MINIMUM TIME NECESSARY TO ACHIEVE THE DESIRED SURGICAL EFFECT 5 After successful completion of these steps the bipolar activation tone on the bipolar generator sounds and the system is ready for operation In operation the bipolar indicator bar illuminates indicating the current flowing between tines DO NOT ATTEMPT TO CONNECT O
29. R DISCONNECT ANY CABLE DURING POWER ACTIVATION Checking the End Point Monitoring System Bipolar The response of the End Point Monitor may be tested during use 1 Set the generator at 5 to 10 watts depending upon the generator characteristics 2 Touch the tines of the instrument together There should be a smooth registration of the current on the bar graph scale The clicking will also change its rate in correspondence with the current When performing this check for the first time with a particular bipolar generator start at a low setting then increase the setting to obtain a mid scale deflection of the bar graph This test ensures that all three components cord bipolar instrument and End Point Monitor are functional 3 8 02087 001 Setup and Tests Mechanical Inspection The AEM Monitor and End Point Monitor require minimal maintenance It is recommended that the AEM Monitor be inspected by qualified service personnel at least twice a year This inspection should include the list below Periodically the following list should be checked ELECTRICAL SHOCK HAZARD GROUND NUT MUST BE SECURE Ground nut properly secured to ground post No evidence of damage on insulation of wiring and cable Connectors and cables are fully seated All hardware is securely fastened AEM Monitor End Point Monitor system check Electrical Inspection Verification of the End Point Monitor Display Encision reco
30. SSORY CABLE BEING IN CLOSE PROXIMITY TO THE CONDUCTIVE OBJECT ENSURE THAT THE INSULATION OF CONVENTIONAL NONSHIELDED DISPOSABLE AND REUSABLE LAPAROSCOPIC INSTRUMENTATION IS INTACT COMPROMISED INSULATION OF NONSHIELDED INSTRUMENTS MAY LEAD TO SHOCKS OR BURNS TO THE PATIENT OR SURGICAL PERSONNEL WHEN USING LAPAROSCOPIC INSTRUMENTATION WITH METAL CANNULAS THE POTENTIAL EXISTS FOR ABDOMINAL WALL BURNS TO OCCUR IN THE EVENT OF DIRECT ELECTRODE TIP CONTACT TO THE CANNULA 02087 001 lt Foreword Active Accessories and AEM Monitor continued REFER TO THE CANNULA 5 INSTRUCTIONS BEFORE INSERTING THE ELECTRODE INTO THE CANNULA TO AVOID DAMAGING THE ELECTRODE OR INJURING THE PATIENT INSERT AND WITHDRAW THEM CAREFULLY INSPECT CORDS FOR BREAKS CRACKS NICKS OR OTHER DAMAGE BEFORE EVERY USE ENSURE THAT END OF LIFE INDICATORS ARE NOT PRESENT IF ANY OF THESE ARE PRESENT DO NOT USE FAILURE TO OBSERVE THIS PRECAUTION MAY RESULT IN INJURY OR ELECTRICAL SHOCK TO THE PATIENT OR OPERATING PERSONNEL DAMAGED EXTERNAL INSULATION ON INSTRUMENTS AND INCORRECT SETUP OF THE AEM MONITOR MAY RESULT IN A RISK OF UNINTENDED PATIENT BURN DO NOT USE PRODUCT HAVING DAMAGED INSULATION Caution READ THE INSTRUCTIONS WARNINGS AND CAUTIONS PROVIDED WITH THE AEM MONITORING SYSTEM ACCESSORIES BEFORE USING THEIR SPECIFIC INSTRUCTIONS ARE NOT INCLUDED IN THIS MANUAL WHEN AN ALERT IS PRESENTED BY THE AEM MONITOR DISCON
31. TH TO THE PATIENT RETURN ELECTRODE THAT INCLUDES THE SKIN TO SKIN CONTACT POINT CURRENT PASSING THROUGH SMALL SKIN TO SKIN CONTACT POINTS IS CONCENTRATED AND MAY CAUSE A BURN THIS IS TRUE FOR EARTH REFERENCED AND ISOLATED OUTPUT GENERATORS TO REDUCE THE POTENTIAL FOR ALTERNATE SITE SKIN BURNS DO ONE OR MORE OF THE FOLLOWING e AVOID SKIN TO SKIN CONTACT POINTS SUCH AS FINGERS TOUCHING LEG WHEN POSITIONING THE PATIENT e PLACE TWO TO THREE INCHES OF DRY GAUZE BETWEEN CONTACT POINTS TO ENSURE THAT CONTACT DOES NOT OCCUR e POSITION THE PATIENT RETURN ELECTRODE TO PROVIDE A DIRECT CURRENT ROUTE BETWEEN THE SURGICAL SITE AND THE RETURN ELECTRODE WHICH AVOIDS SKIN TO SKIN CONTACT IN ADDITION PLACE PATIENT RETURN ELECTRODES ACCORDING TO THE MANUFACTURER S INSTRUCTIONS KEEP ELECTRICAL CONNECTIONS DRY WHILE IN USE TO PREVENT POTENTIAL CONDUCTION OF HF CURRENT TO THE USER POTENTIALLY HAZARDOUS CONDITIONS MAY EXIST WHEN ACCESSORIES OF SIMILAR CONNECTOR TYPES ARE INTERMIXED BE CERTAIN THAT ACCESSORIES ARE APPROPRIATE FOR THE TYPE OF ELECTROSURGICAL GENERATOR OUTPUT USED AND THE INTENDED APPLICATION LAPAROSCOPIC SURGERY MAY RESULT IN GAS EMBOLISM DUE TO INSUFFLATION OF GAS INTO THE ABDOMEN iv 02087 001 Foreword General Electrosurgical Hazards continued WHILE USING ELECTROSURGERY THE PATIENT SHOULD NOT BE ALLOWED TO COME INTO DIRECT CONTACT WITH GROUNDED METAL OBJECTS E G SURGICAL TABLE FRAME INSTRUMENT TABLE
32. TINUE USE OF THE ELECTROSURGICAL CURRENT IMMEDIATELY FIND THE CAUSE OF THE ALERT AND CORRECT IT BEFORE CONTINUING USE AEM MONITORING WILL NOT FUNCTION WITHOUT THE USE OF DUAL PAD RETURN ELECTRODES AND AN ELECTROSURGICAL UNIT EQUIPPED WITH CONTACT QUALITY MONITORING PATIENT SAFETY TECHNOLOGY DAMAGED INTERNAL INSULATION OF THE INSTRUMENT OR LOSS OF SHIELD CONTINUITY MAY CAUSE ESU RETURN PAD ALARMS TRIGGERED BY THE AEM MONITOR S FAULT INDICATORS FOR MAXIMUM PATIENT SAFETY DISCONTINUE USE OF THE INSTRUMENT IF THIS OCCURS A SINGULAR AEM INSTRUMENT MUST BE THE SOLE CONDUCTOR OF ENERGY TO TISSUE DO NOT CONDUCT ENERGY BY TOUCHING AN AEM INSTRUMENT TO A SECOND INSTRUMENT CONTACTING TISSUE THE SECOND DEVICE WILL NOT BE PROTECTED FROM CAPACITIVE COUPLING AND INSULATION FAILURE LIMIT POWER SETTING TO 80 WATTS OR LOWER UNLESS FURTHER LIMITED BY THE INSTRUMENT INSTRUCTIONS FOR USE OTHERWISE SPURIOUS INSULATION FAILURE ALARMS MAY OCCUR GOOD OPERATING ROOM PRACTICE SUGGESTS THAT CONNECTIONS OF ACCESSORIES ELECTROSURGICAL GENERATORS BE MADE ONLY WHILE THE GENERATOR 15 OFF OR ON STANDBY DO NOT USE THE AEM MONITOR UNLESS THE SYSTEM PROPERLY COMPLETES THE AUTOMATIC SELF CHECK OTHERWISE AEM FUNCTIONS MAY NOT BE OPERATIVE vi 02087 001 Electromagnetic Compatibility Hazards Caution USE OF ACCESSORIES TRANSDUCERS AND CABLES OTHER THAN THOSE SPECIFIED WITH THE EXCEPTION OF TRANSDUCERS AND CABLES SOLD BY T
33. TRUMENT MUST BE THE SOLE CONDUCTOR OF ENERGY TO TISSUE DO NOT CONDUCT ENERGY BY TOUCHING AN AEM INSTRUMENT TO A SECOND INSTRUMENT CONTACTING TISSUE THE SECOND DEVICE WILL NOT BE PROTECTED FROM CAPACITIVE COUPLING AND INSULATION FAILURE DO NOT ATTEMP TO CONNECT OR DISCONNECT ANY CABLE DURING POWER ACTIVATION Responding to Monitor Alarms When using AEM Monitoring successful electrosurgery depends upon an absence of any critical fault conditions Should one develop the AEM Monitoring System disables the attached electrosurgical generator with contact quality monitor from further functioning until you correct the alarm condition The AEM Monitor extinguishes its READY indicator and illuminates one or more of the alarm indicators RETURN ELECTRODE Amber Alarm Indicator SETUP FAULT Check that the return electrode connector is securely connected into the AEM Monitor inhibit adapter and the inhibit adapter is connected to the return electrode receptacle of the electrosurgical generator with contact quality monitoring If both connections have been made and the amber indicator continues to illuminate replace the return electrode 02087 001 6 7 Surgical Use 6 8 CORD Alarm Indicator SETUP FAULT Check AEM cord to ensure that it is securely connected to the front panel receptacle marked AEM CORD and that the other end is connected to an AEM integrated instrument If both connections
34. alarms so that the proper corrective action can be taken During minimally invasive procedures monopolar electrosurgery has safety and performance issues that differ from those of open procedures The safety of the patient depends in part on the quality of electrical insulation on the extended electrodes and the amount of current which is conducted through the insulation due to capacitance These potential electrical problems are compounded by the fact that only a small portion of the total length of the insulation may be viewed by the surgical team Electrode Insulation Abdominal Wall A Cannula Active Electrode Zones 2 amp 3 are likely out of the surgeon s field of view 02087 001 5 1 Principles of Operation 5 2 Electrosurgical equipment produces high voltage radio frequency energy These high voltages require insulation on the electrodes to eliminate the flow of current except at the tip Normal wear and tear of the instruments may degrade the insulation and such defects may be outside of the normal field of view Consequently a failure capable of causing harm may go unnoticed Electrode Insulation Failure Abdominal Wall Active Electrode Capacitively coupled currents also have the potential for causing burns The radio frequency energy used in electrosurgery will flow between closely spaced conductors even though there is no direct connection between them The active elec
35. all receptacle If necessary replace the power cord Open the fuse drawer Check the fuses and replace if necessary with 0 5A 5 X 20 mm fuse Install the fuse drawer Check the power entry module and its cable connections if faulty repair or replace the power entry module Test the switch if faulty replace the power switch Measure the line voltage at input terminals on J1 of the power supply line voltage is not present replace the AC power cable Check the power supply s output voltages at power supply s J2 Pins 2 and 4 are ground Pin 1 15 0 1V Pin 3 5 27 05V Pin 5 15 0 1V If any voltage is incorrect adjust or replace the power supply Check and reseat all internal connections Turn on and measure the power supply voltages at J4 on the ESM Main Board If any voltage is incorrect replace DC power cable Measure power supply voltages at J4 on the EPM Main Board If any voltage is incorrect replace Cable If the above steps have failed return the unit for repair 4 7 Troubleshooting Situation No bar graph indication Possible Cause End Point Monitor Remote plugged into the End Point Monitor Malfunctioning power supply Internal cables loose disconnected or malfunctioning Malfunctioning connection between Front Panel receptacles and EPM Main Board Malfunctioning EPM Main Board Malfunctioning EPM Display Board Recommended Action V
36. are made and the amber indicator continues to illuminate replace the AEM cord INSULATION Red Alarm Indicator OPERATIVE FAULT ILLUMINATION OF A RED INSULATION INDICATOR INDICATES AN UNSAFE ACTIVE ACCESSORY AND DEACTIVATES THE ELECTROSURGICAL GENERATOR THE INSULATION INDICATOR REMAINS ON FOR 30 SECONDS AND THE GENERATOR IS INHIBITED FOR 10 SECONDS FOLLOWING A BEEP FROM THE AEM MONITORING SYSTEM Replace both the instrument and Encision shield or integrated AEM instrument whichever is appropriate If the INSULATION indicator continues to illuminate use a backup AEM Monitor to complete the surgical procedure If for any reason an AEM alarm continues from your AEM Monitor use a backup AEM Monitor to complete the surgical procedure Preparing the AEM Monitor for Reuse 1 Turn off the AEM Monitor 2 Disconnect all accessories ELECTRIC SHOCK HAZARD ALWAYS UNPLUG THE AEM MONITOR BEFORE CLEANING 3 Follow the procedures approved by your institution or use a validated infection control procedure Use a mild cleaning solution or disinfectant and a damp cloth to thoroughly wipe all surfaces and the power cord Notice DO NOT ALLOW FLUIDS TO ENTER THE CHASSIS DO NOT CLEAN THE AEM MONITOR WITH ABRASIVE CLEANING OR DISINFECTANT COMPOUNDS SOLVENTS OR OTHER MATERIALS THAT COULD SCRATCH THE PANELS OR DAMAGE THE UNIT DO NOT STEAM STERILIZE THE AEM MONITOR 02087 001 Technical Specifications 7 Technical Specifica
37. as indicated on the scale underneath Audible Indication adjustable volume clicks The clicks are delivered at rate proportional to indicated current Connectors and Cables AEM CORD Connects the AEM Instrument active conductor to the electrosurgical generator and shield conductors to the AEM Monitor both via the AEM Cord Adapter Length 10 5 3 2 m standard reusable cord 9 5 2 9 m standard disposable cord 12 3 7 m extended disposable cord limited distribution 02087 001 7 3 Technical Specifications Inhibit Adapter green block attached by means of a cable to front panel Cable length 21 53 cm Dual area Return Electrode plug on one face which connects to the electrosurgical generator Dual area Return Electrode receptacle on opposite face which connects to Return Electrode plug attached to the actual return electrode Senses the pin of a dual area return electrode AEM CORD receptacle on front panel A unique two conductor receptacle which receives the AEM Cord Adapter There is no preferred polarity BIPOLAR GENERATOR jacks two arranged vertically on front panel Two standard banana jacks Provided for connecting to the bipolar electrosurgical generator There is no preferred polarity Bipolar Jumper Cord dual banana plugs on each end of a cord Provided for connecting the AEM Monitor to the bipolar electrosurgical generator Retention Bracket provided There is no preferred polarity
38. ators are also on AEM Cord Return Electrode or Insulation Electrosurgical generator does not enter ARM alert state when activated during AEM Cord fault 02087 001 Possible Cause Inappropriate internal state of the AEM Monitor Malfunctioning electrosurgical generator Malfunctioning connection to ESM Main Board Defective ESM Main Board Defective ESU Keyed detector board Troubleshooting Recommended Action Turn power switch Off for 30 seconds then On Retry operation If the Ready indicator is still inappropriately lighted continue with tests Remove the adapter from the electrosurgical generator if it does not go into a contact quality alert replace the electrosurgical generator Remove the adapter from the ESU disconnect P1 from J1 and measure the resistance between pins 5 amp 6 of P1 If lt 2 ohms replace the adapter assembly Disconnect P1 from J1 and measure the resistance between pins 5 amp 6 of J1 If lt 2 ohms return the unit for repair Return the unit for repair 4 5 Troubleshooting Situation Possible Cause AEM Monitor does not Arc detector failure detect operative fault Insulation light remains off during fault condition Short detector failure Blown fuse s on Unknown power supply Recommended Action Set up the AEM Monitor with the electrosurgical generator in the normal manner using a pencil electrode Instead of connecting
39. both Return Electrode indicator is on and AEM Cord indicator is on Electrosurgical generator in alert state Dual pad open or short circuited Poor connection in return electrode circuit Malfunctioning electrosurgical generator Malfunctioning connection to ESM Main Board Malfunctioning ESM Main Board Recommended Action See recommended action for both Return Electrode indicator is on and AEM Cord indicator is on Reset the electrosurgical generator contact quality monitor Install dual pad so that correct resistance is seen by the electrosurgical generator Disconnect and reconnect return electrode connection to the adapter and the adapter connection to the electrosurgical generator Plug the return electrode connector directly into the electrosurgical generator If the electrosurgical generator still shows an alarm status replace the electrosurgical generator Short pins on either side of the Adapter only 1 short Measure the resistance between the corresponding pins on the other side If gt 2 ohms add short between pins 5 6 of J1 If still gt 2 ohms return the unit for repair Remove all connections to the adapter and measure the resistance between pins 5 amp 6 of J1 If 22 ohms return the unit for repair 02087 001 Situation Electrosurgical generator not in alert state during fault The Ready indicator is off and any of the following indic
40. ce level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 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 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephone 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 AEM Monitor and accessories is used exceeds the applicable RF compliance level above the equipment should be observed to verify to normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the equipment Over the frequency range 150 kHz to 80 MHz the field strengths should be less than 3 Vm 02087 001 Technical Specifications Recommended separation distances between portable and mobile RF communications equipment and the AEM Monitor and accessories EN 60601 1 2 2002 Table 206 The Model EM2 series AEM Monitor and accessories are intended for use in an electromagnetic
41. chassis Tighten until snug Test the unit per instructions Unit is ready for use Fuse Replacement NOTE FUSE REPLACEMENT PROCEDURE IS ONLY FOR EXTERNAL FUSES DO NOT REPLACE INTERNAL FUSES ON POWER SUPPLY IF FUSES ARE BLOWN REPLACE THE POWER SUPPLY OR SEND THE UNIT IN FOR REPAIR Release the fuse drawer by inserting a screwdriver into the slot on top of the fuse drawer and pulling gently on the drawer Slide the drawer out Remove the blown fuse from the drawer Replace the blown fuse with one of the same type and rating Slide the fuse drawer into its slot until it snaps into place Inhibit Adapter Replacement 1 2 02087 001 Remove cover from the AEM Monitor Cut inhibit adapter cable at strain relief on inside of unit next to the sheet metal and pull inhibit adapter cable out from the front 8 3 3 Disconnect the white locking connector that attaches the inhibit adapter cable to the ESM Main board i 4 Mark the color of the wire from the inhibit adapter onto the locking connector 5 With a knife or small screwdriver push the metal part of the contacts down on the white connector You will need to push the contact towards the wire while pushing down Pull the wire after you have pushed the contact back The contact should pull out of the connector Look at the metal contact while removing you will need to know the correct orientation of the contact to put the n
42. ctrode is unplugged thus causing the AEM Cord indicator to illuminate when a short is detected SHORT signal and the Insulation indicator to illuminate when an arc is detected ARC signal The Ready indicator illuminates when the ESM Adapter Relay is closed The ESM Adapter Relay is driven by its own PLD output and it is closed when none of the fault conditions mentioned above are present and after five seconds of an Insulation fault The ESM Adapter Relay is open during the POST cycle The beep is created by driving a speaker with a 512 Hz square wave signal that is gated by the PLD logic to cause 0 5 second beeps separated by a 0 5 second pause at the required times Two beeps are generated at the end of the POST cycle and one is generated when an Insulation fault is detected followed by three beeps five seconds later Visual Indicators The visual indicators are LEDs located on the front panel The power On illuminates from the 15 V supply the AEM Cord Return Electrode Insulation and Ready indicators are powered by the 15 V supply and controlled by the Logic circuitry Aural Indicator A small speaker is mounted on the rear panel of the chassis and it produces the beep for the AEM Monitor alarms and a click for the End Point Monitor changes 02087 001 5 7 Principles of Operation 5 8 Theory of Operation End Point Monitoring System The surgeon may use the End Point Monitor a radio frequency RF a
43. ctrosurgical Generator ive Conductor Inhibit Adapter Shield Conductor Cable AEM Monitor 1 Detection of Insulation Failure Return 2 Protection Against Capacitive Coupling Electrode The AEM Monitor measures the currents flowing in the AEM integrated instruments detects faults in the insulation monitors the connections of the shield and the return electrode The AEM Monitor includes an inhibit adapter which connects between the electrosurgical generator and the return electrode When an insulation or connection fault is detected the AEM Monitor interrupts the contact quality monitor circuit of the electrosurgical generator In the event of an insulation fault an alarm sounds and a visual indicator illuminates The normal response of the generator to the contact quality circuit interruption is inhibition of radio frequency energy output Notice THE PEAK OPEN CIRCUIT VOLTAGE PRODUCED BY THE ELECTROSURGICAL GENERATOR MAY BE SLIGHTLY REDUCED WHEN IT IS USED WITH THE AEM SYSTEM NORMALLY THE VOLTAGES PRODUCED UNDER LOADED CONDITIONS ARE NOT SIGNIFICANTLY ALTERED 02087 001 5 3 Principles of Operation Circuit Operation Monopolar The Block Diagram shown on page 5 shows several functional blocks Each block shown in a dotted enclosure will show how the subfunctions are grouped in the current implementation The circuit descriptions of each of these blocks are
44. described in this section ESM Adapter Relay The adapter places the AEM Monitor relay electrically between the return electrode and the electrosurgical unit ESU The relay contact is used to place the ESU in normal or inhibit function depending on the results of the AEM Monitor measurements When the contact is opened the AEM Monitor signals the ESU to inhibit because the contact quality monitor within the ESU measures high impedance The adapter also contains a switch which is actuated by a feature on the return electrode connector A switch activates a setup fault in the presence of the wrong type of electrode This ensures the connection of the correct type of return electrode A conductivity monitor reads the state of the switch ESM Current Monitor To determine the status of electrode insulation the AEM Monitor measures two aspects of the current flowing in the conductive shield that encloses the insulation Criteria are placed on the measurements and the results of the two measurements are passed to the logic section for alarm generation if required The first criterion which must be met is that the current measured over its total band width must be less than a preset value Currents above this value generate an alert The value at which the alarm generates varies with the waveform used but is typically between 350 and 600 mA rms for cutting waveforms Currents of this magnitude or higher are produced at typical control settings when th
45. e indication are neither fully on nor off 4 10 Possible Cause Faulty power supply Internal cables loose disconnected or malfunctioning Malfunctioning EPM Display Board or EPM Main Board Recommended Action Check the power supply s output voltages at power supply s J2 Pins 2 and 4 are ground Pin 1 15 0 1V Pin 3 5 27 05V Pin 5 15 0 1V If any voltage is incorrect adjust or replace the power supply Check and reseat all internal connections Turn on and measure power supply voltages at J4 on the ESM Main Board If any voltage is incorrect replace DC power cable Measure power supply voltages at J4 on the EPM Main Board If any voltage is incorrect replace I F Cable If the above steps have failed return the unit for repair 02087 001 Situation Front panel display does not turn off when End Point Monitor Remote is plugged into rear connector 02087 001 Possible Cause Malfunctioning Main Board Internal cables loose disconnected or malfunctioning Malfunctioning End Point Monitor Remote unit Troubleshooting Recommended Action Connect the electrosurgical generator bipolar output to the Bipolar Generator receptacle using 2 banana cords Short the Bipolar Accessory receptacle with another banana cord Set the bipolar output power to approximately 3 watts Remove the remote connector and short pins 6 4 7 in J3 If the front panel bar graph stil
46. e a comparator array which convert an analog input to the appropriate switch closures and current source to form a bar whose length is proportional to the magnitude of the current Offset and gain are inherent in the function of the ICs U4 6 and are accommodated by the RMS to DC convertor Segment intensity is controlled by the values of R1 R3 and R5 02087 001 Surgical Use 6 Surgical Use Before Surgery It is important to mount the AEM Monitor under the electrosurgical generator so the adapter cable reaches the return electrode connector The AEM Monitor is supplied with feet spaced for compatibility with most equipment carts Recesses are provided in the cover of the AEM Monitor so most specified electrosurgical generator products may be located securely upon it FIRE HAZARD DO NOT USE EXTENSION CORDS ELECTRIC SHOCK HAZARD CONNECT THE POWER CORD TO A PROPERLY GROUNDED RECEPTACLE DO NOT USE POWER PLUG ADAPTERS ELECTRIC SHOCK HAZARD DO NOT ATTEMPT TO CONNECT OR DISCONNECT ANY CABLE DURING POWER ACTIVATION Caution CONNECT THE POWER CORD TO A WALL OUTLET HAVING THE CORRECT VOLTAGE OTHERWISE PRODUCT DAMAGE MAY RESULT DO NOT USE THE AEM MONITOR UNLESS THE SYSTEM PROPERLY COMPLETES THE AUTOMATIC SELF CHECK OTHERWISE AEM FUNCTIONS MAY NOT BE OPERATIVE 1 Connect the AEM Monitor power cord to a wall receptacle with the proper voltage 2 Turn on the AEM Monitor The system completes an automatic self check All of
47. e active electrode is shorted to the shield The T2 current transformer with R14 produces a voltage signal proportional to the shield current U8 forms full wave rectifier with U10 differently amplifying the filtered result yielding a current magnitude signal 098 then compares this magnitude with a preset value determined by R57 and R58 and the results of this comparison are input to the logic section The second current criterion involves a filtered component of the current centered around a frequency which is well below the principle frequency of electrosurgical waveforms When the magnitude of this component of current exceeds a predetermined fraction of the magnitude of the wide band current an alarm is generated This typically happens when a spark is generated between an active conductor and the shield and that may occur over the entire range of generator coagulation control settings U3 forms a 3 pole filter for the current signal U5 detects the filtered signal with U10A amplifying it and U9A performing the comparison ESM Conductivity Monitors The conductivity monitors sense the circuit resistance in the AEM Monitor circuit and the dual electrode sense switch circuit When the circuit resistance is less than approximately 50 ohms the circuit outputs a positive logic level signal When greater circuit resistance is present the circuit outputs a low logic level signal The circuit outputs are isolated from the inputs The AEM Monitor bl
48. eet spaced for compatibility with most equipment carts Recesses are provided in the cover of the AEM Monitor so most specified electrosurgical generator products may be located securely upon it The electrosurgical generator must be placed directly on top of the AEM Monitor A metal shelf or other separation between the AEM Monitor and the electrosurgical generator may prevent proper AEM Monitor indication of a setup fault ELECTRICAL SHOCK HAZARD CONNECT THE POWER CORD TO A PROPERLY GROUNDED RECEPTACLE DO NOT USE POWER PLUG ADAPTERS FIRE HAZARD DO NOT USE EXTENSION CORDS ELECTRICAL SHOCK HAZARD DO NOT CONNECT WET ACCESSORIES TO THE GENERATOR ENSURE THAT ACCESSORIES AND ADAPTERS ARE CORRECTLY CONNECTED AND THAT NO METAL IS EXPOSED DO NOT ATTEMPT TO CONNECT OR DISCONNECT ANY CABLE DURING POWER ACTIVATION Caution INSPECT ACCESSORIES AND CORDS FOR BREAKS CRACKS NICKS OR OTHER DAMAGE BEFORE EVERY USE INSURE THAT END OF LIFE INDICATORS ARE NOT PRESENT IF ANY OF THESE ARE PRESENT DO NOT USE FAILURE TO OBSERVE THIS PRECAUTION MAY RESULT IN INJURY OR ELECTRICAL SHOCK TO THE PATIENT OR OPERATING PERSONNEL CONFIRM PROPER POWER SETTINGS BEFORE PROCEEDING WITH SURGERY USE THE LOWEST POWER SETTING POSSIBLE FOR THE MINIMUM TIME NECESSARY TO ACHIEVE THE DESIRED SURGICAL EFFECT Notice WHEN USING ES9015 UNIVERSAL ADAPTER SEE INSTRUCTIONS FOR USE DOCUMENT 02677 02087 001 3 1 Setup and Tests POWER CORD Cautio
49. environment in which radiated RF disturbances are controlled The user of the Model EM2 series AEM Monitor and accessories can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Model EM2 series AEM Monitor and accessories as recommended below according to the maximum output power of the of the communications equipment Rated maximum output Separation distance according to frequency of transmitter power of transmitter m 150 kHz to 80 80 MHz to 800 800 MHz to 2 5 Ww MHz MHz GHz d 1 2 JP d 1 2 VP d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum out put power not listed above the recommended distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 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 and people Essential Performance confirmed by electromagnetic immunity testing e Shield function Detection of insulation breakdown and signal to ESU if threshold
50. erify that nothing is plugged into the Remote Display connector located on the rear of the End Point monitor Check the power supply s output voltages at power supply s J2 Pins 2 and 4 are ground Pin 1 15 0 1V Pin 3 5 27 05V Pin 5 15 0 1V If any voltage is incorrect adjust or replace the power supply Check and reseat all internal connections Turn on and measure the power supply voltages at J4 on the ESM Main Board If any voltage is incorrect replace the DC power cable Measure power supply voltages at J4 on the EPM Main Board If any voltage is incorrect replace the I F Cable Measure the resistance between the upper Bipolar Generator receptacle and the right most Bipolar Accessory receptacle Measure the resistance between the lower Bipolar Generator receptacle and the left most Bipolar Accessory receptacle while pins 1 amp 2 of J1 of the EPM Main Board are being shorted If any of the above measurements is 2 ohms replace the front panel Connect the electrosurgical generator bipolar output to the Bipolar Generator receptacle by using 2 banana cords Short the Bipolar Accessory receptacle with another banana cord Set the bipolar output power to approximately 3 watts Connect a DC voltmeter across J3 pin 1 amp 2 If the voltmeter does not show an indication when the electrosurgical generator is activated return the unit for repair If the above steps have failed return the unit
51. es that fit into this socket Test Probe 14 Connect a pencil electrode to the electrosurgical generator with a contact quality monitor Verify that the following occurs The AEM Monitor Alarm indicator is extinguished The AEM Monitor Ready indicator illuminates The electrosurgical generator with the contact quality monitoring system ARM enabled is in the normal operating state 15 Set the electrosurgical generator with the contact quality monitoring system ARM to 20 Watts in the standard coagulation mode For the ConMed 5000 set the power to 35 Watts in the standard coagulation mode 16 Test When using ES9005 Adapter Activate the electrosurgical generator and touch the alligator clip with the pencil electrode It may be necessary to touch the alligator clip with the pencil electrode for a few seconds with the ConMed 5000 For the ConMed 2450 it may be easier to trigger an insulation fault if the spark is initiated when the pencil is close to the alligator clip 3 6 02087 001 Setup and Tests When using the ES9015 Adapter Activate the electrosurgical generator and touch the distal end of test probe with the pencil electrode It may be necessary to touch the test probe with the pencil electrode for a few seconds with the ConMed 5000 For the ConMed 2450 it may be easier to trigger an insulation fault if the spark is initiated when the pencil is close to test probe Verify that the
52. ew one into place 6 Insertthe inhibit adapter cable from the new inhibit adapter through the hole in the front panel You may need a pair of pliers to pull the cable through Only pull on the strain relief portion of the cable Note may help to squeeze the strain relief and hold it This will compress the material and make it easier to pull through the front panel Also the use of alcohol on the strain relief will help 7 Insert the metal contacts into the white connector in the correct location Gently pull the wires after all of the contacts have been inserted into the connector to insure they are locked into position 8 Attach white connector to PC board Reattach cover onto top of unit Push here to remove contact Push the contact down and towards the wire View of connector is from the bottom Black Red Yellow Perform AEM Monitor functions properly per section 3 of the AEM Monitor Operator Service Manual Perform Normal Electrical Safety Tests as required per your Hospital s Protocol 8 4 02087 001 Policy and 9 Repair Policy amp Procedure Obtaining a Return Authorization Number Before you return the AEM Monitor front panel or power supply to Encision call the Encision Customer Service Center to obtain a Return Authorization Number or call your Encision Representative for assistance Have the following Information ready when you call hospital clinic name cu
53. following occurs 3 4 02087 001 13 02087 001 Setup and Tests The AEM Monitor Return Electrode indicator illuminates The AEM Monitor Ready indicator extinguishes The contact quality monitoring system ARM on the electrosurgical generator signals an alarm Reconnect the return electrode from the AEM Monitor inhibit adapter Verify that the following occurs The AEM Monitor Return Electrode indicator extinguishes The AEM Monitor Ready indicator illuminates The contact quality monitoring system ARM on the electrosurgical generator no longer signals an alarm Active Electrode Spark to Shield Connector Note that the AEM Monitor may occasionally reset during the spark test this is indicated by all the front panel lights coming on Simply repeat the test if this occurs Contact Encision if the problem persists The repair policy is in section 9 of this manual Setup When using the ES9005 Adapter Connect a miniature alligator clip between the two pins of the AEM Monitor AEM Cord receptacle Continued next page 3 5 Setup and Tests When using the ES9015 Universal Adapter Insert any test probe into either one of the shield sockets in the hand control receptacle of the Universal Adapter see Figure below The socket inner diameter is approximately 2 3mm A Tektronix ATLO1 Probemaster 9100 Series Modular Test Leads and Fluke TP2 Slim Reach Test Probes are examples of prob
54. following occurs There is a visible spark at the active electrode The AEM Monitor Ready indicator extinguishes for ten seconds The AEM Monitor Insulation indicator illuminates for thirty seconds The contact quality monitoring system on the electrosurgical generator alarms The AEM Monitor alarms Setup of the End Point Monitor System Bipolar Notice IF YOU ARE USING THE ENCISION END POINT MONITOR REMOTE DISPLAY EMR MOUNT THE DISPLAY NEAR THE VIDEO MONITOR OR AT ANOTHER LOCATION IN THE VIEW OF THE OPERATING ROOM STAFF IF BOTH BIPOLAR AND MONOPOLAR FUNCTIONS ARE BEING USED THE MONOPOLAR INSTRUMENT MUST REMAIN CONNECTED TO AVOID SPURIOUS ALARMS Caution WHEN USING THE ENCISION END POINT MONITOR REMOTE DISPLAY ONLY THE REMOTE ILLUMINATES DURING BIPOLAR CURRENT FLOW THE END POINT MONITOR FRONT PANEL ON THE ENCISION MONITORING SYSTEM DOES NOT ILLUMINATE 1 Plug one end of the Bipolar Jumper Cable into the vertical pair of jacks on the AEM Monitor labeled BIPOLAR GENERATOR the other end into the ESU bipolar output jacks ELECTRICAL SHOCK HAZARD ACCESSIBLE PINS OF THE JUMPER CORD MAY LEAD TO SHOCK OR BURNS TO SURGICAL PERSONNEL IF THE GENERATOR BIPOLAR OUTPUT IS ACTIVATED WHILE THE BIPOLAR CORD IS PLUGGED INTO THE GENERATOR RECEPTACLE BUT THE OTHER END IS NOT PLUGGED INTO THE AEM MONITOR RECEPTACLE ELECTRICAL SHOCK HAZARD DO NOT CONNECT WET ACCESSORIES TO THE GENERATOR ENSURE THAT ACCESSORIES A
55. for repair 02087 001 Situation No audible indication no clicking correct bar graph indication 02087 001 Possible Cause The Volume Control switch is in the wrong position Malfunctioning speaker speaker Volume Control switch and or cable Malfunctioning EPM Main Board Troubleshooting Recommended Action Set the Volume Control switch to the up position High Measure the voltage between ground end of C6 and the end of R22 nearest the board edge If it is lt 4 8 V return the unit for repair assuming the ESM Main Board is Set the speaker Volume Control switch to High Remove the meter end of the lead connected to R22 and momentarily touch it to ground Perform the above test for the Volume Control switch set to Low and again in Off If a click is not heard from the speaker while the switch is in either High or Low replace the volume control switch Connect the electrosurgical generator bipolar output to the Bipolar Generator receptacle using 2 banana cords Short the Bipolar Accessory receptacle with another banana cord Set the bipolar output power to approximately 3 watts and the Volume Control switch to High If a clicking is not heard when the electrosurgical generator is activated return the unit for repair 4 9 Troubleshooting Situation Fuzzy Indication on the bar graph When indicating near the high end of the current scale the bars at the right end of th
56. from insulation failure or capacitive coupling AEM instruments have a patented multi layered design with a built in shield much like the third wire ground in standard electrical cords The shield in these instruments is referenced back to a monitor at the electrosurgical generator In the event of a harmful level of stray electrical energy the monitor shuts down the power at the source ensuring patient safety The AEM system protects against capacitive coupling by providing a neutral return path for capacitively coupled electrical current Capacitively coupled energy is continually drained away from the instrument and away from the patient through the protective shield built into all AEM instruments Monopolar Surgery In monopolar electrosurgery the surgical instrument contains only the active electrode A separate return electrode to the patient recovers the current that passes through the patient and returns it safely to the generator Monopolar electrosurgery is used for most surgical procedures that require sparking to tissue such as those in which tissue must be cut or coagulated over wide areas Bipolar Surgery In bipolar electrosurgery the surgical instrument includes both electrodes A return electrode need not be used Current flows between the two electrodes and through the tissue contacted by the instrument heating that tissue In bipolar electrosurgery close control is needed to ensure the correct degree of heating
57. fy the deficiency and the AEM Monitor opens one side of the return electrode circuit causing the electrosurgical generator to detect a pad fault and disable its output Shield Cable and Return Electrode Switch Threshold 50 ohms 2096 Monopolar Operative Fault Detection If there is excessive shield current or arcing between the shield and the active electrode causing an operative fault a red indicator illuminates to identify an insulation fault an audible alarm is generated and the AEM Monitor opens one side of the return electrode circuit causing the electrosurgical generator to detect a pad fault and disable its output Radio Frequency Current Sensing Current sensing and spark detection are provided Minimum electrosurgical generator output for reliable insulation fault detection 20 Watts Bipolar Current Measurement The number of segments illuminated in the bar graph display corresponds to the magnitude of the bipolar current In addition to the visual display the AEM Monitor generates clicks at a rate proportional to the measured current and the click volume is adjustable to high low or off Accuracy 10 of full scale Range 0 1 to 1 1 Ampere Maximum current without damage 3 0 Amperes Click Rate 25 to 40 Hz at 1 0 Ampere Remote Bipolar Current Indication An End Point Monitor Remote Display EMR is available which can be placed in a convenient viewing position The Encision End Point Monitor Remote Display EMR ind
58. g The AEM Monitoring System consists of two distinct functions e Active electrode monitoring is intended to control stray monopolar energy caused by insulation failure and capacitive coupling in surgical instruments on the shaft of the instrument e End point monitoring is intended to aid the surgeon in determining the end point of bipolar electrosurgical desiccation Contraindications There are no known contraindications for use of the AEM Monitor Caution READ AND REVIEW ALL INSTRUCTIONS IN THIS MANUAL AND IN INSTRUMENT AND ACCESSORIES INSTRUCTIONS FOR USE PRIOR TO USING THE AEM SYSTEM Caution FEDERAL USA LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Caution THE AEM MONITOR IS DESIGNED TO SAFELY DELIVER ELECTROSURGICAL ENERGY AND TO PREVENT INJURY CAUSED BY INSULATION FAILURE AND CAPACITIVE COUPLING THE ENCISION AEM MONITOR IS NOT INTENDED TO TEST FOR INSULATION DAMAGE ON LAPAROSCOPIC INSTRUMENTS DO NOT ATTEMPT TO USE THIS SYSTEM AS AN INSTRUMENT INSPECTION TOOL 02087 001 i Foreword Conventions Used in this Manual INDICATES A POTENTIALLY HAZARDOUS SITUATION WHICH IF NOT AVOIDED COULD RESULT IN SERIOUS INJURY OR DEATH Caution INDICATES A HAZARDOUS SITUATION WHICH IF NOT AVOIDED MAY RESULT IN MINOR OR MODERATE INJURY Notice INDICATES A HAZARD WHICH MAY RESULT IN PRODUCT DAMAGE Controls indicators and receptacles on the unit appear in bold and or italic capitals
59. ic of a typical location in a typical commercial or hospital environment 02087 001 7 7 Technical Specifications 7 8 Guidance and manufacturer s declaration electromagnetic immunity EN 60601 1 2 2002 Table 204 The Encision Model EM2 series AEM Monitor and accessories are intended for use in the electromagnetic environment specified below The customer or user of the equipment should as sure that it is used in such an environment Immunity IEC 60601 test Compliance Electromagnetic environment test level level guidance Portable and mobile RF communications Equipment should be used no closer to any part of the Model EM2 series AEM Monitor and accessories including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vms 3 Vms d 1 2 80 MHz to 800 MHz IEC 61000 4 6 150kHz to 80 MHz 150kHz to 80 MHz Radiated RF 3 V m 3 V m ip 1 2 P 80 MH MH 61000 4 3 80 MHz to 2 5 GHz 80 MHz to 2 5 d 800 MHz GHz d 2 3 800 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 distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the complian
60. icates the same information as the front panel display but when the Encision End Point Monitor Remote Display is plugged into the REMOTE DISPLAY connector the front panel display is inactive Cord Length 15 feet 4 6 meters Duty Cycle Continuous 02087 001 Technical Specifications Indicators and Alert Functions Setup Fault Indicators AEM CORD yellow light Indicates that the AEM Cord AEM cord adapter or the instrument is not properly connected to the AEM Monitor RETURN ELECTRODE yellow light Indicates that the return electrode is not properly connected the adapter is malfunctioning or that a dual pad electrode is not being used Operative Fault Indicators INSULATION red light Indicates that there is excessive current or arcing between the active electrode and the shield Once triggered the insulation light stays on for 30 seconds Immediately upon detection of fault one beep after approximately 4 seconds 3 beeps The audio volume is fixed and cannot be turned off Status Indicators POWER green light Indicates that the AEM Monitor is plugged in and turned on READY green light Indicates that there are no faults and that the electrosurgical generator can be activated Stays off for ten seconds after operative fault Bipolar Current Indicators RF AMPERES 30 segment bar graph display The number of segments illuminated in the bar graph display corresponds to the magnitude of the bipolar current
61. in Figure 1 Save for reinstallation Remove the screw and lock washer which holds the front panel bracket to the chassis shown by arrow 3 in Figure 1 Save for reinstallation Slide the front panel assembly forward until the studs at the ends of the panel clear the chassis Put the front panel into an antistatic bag and return to the Encision Service Center 02087 001 10 11 12 Replacement Procedures Remove the new front panel from its antistatic bag and orient it in front of the chassis so that the printing is right side up Slide the studs at each end of the front panel into the corresponding holes of the chassis Line up the hole in the front panel bracket with the tapped hole in the bottom of the chassis Reinstall the screw and lock washer which holds the front panel bracket to the chassis shown by arrow 3 in Figure 1 Tighten until snug Reinstall the lock washers and nuts respectively located at the left and right ends of the front panel shown by arrows 1 amp 2 in Figure 1 Reconnect the front panel cables connected to J1 and J2 on the EPM Main Board Reconnect the front panel cables connected to J1 and J2 on the ESM Main Board Reinstall Cover 1 2 4 5 Repeat the tests that failed Proceed only if all tests pass Slide cover over the chassis Line up the holes in the cover with the tapped holes in the chassis Install the six screws previously removed that secure the cover to the
62. into the ESU plug the other end into the AEM Cord receptacle on the AEM Monitor 6 Connect an AEM Cord with an AEM instrument to the AEM Cord Adapter at the ESU 3 2 02087 001 Setup and Tests 7 Verify that the amber AEM Cord light turns off and the green Ready light is on 8 Turn on the electrosurgical generator and enable its contact quality monitoring system It should be in its normal operational state After successful completion of these steps the AEM Monitor is ready for use Optional Functional Test for Operating Room before procedure begins An optional test to verify proper function and integrity of the instruments is described below This test verifies that AEM interment s internal insulation is in good condition and can be expected to perform without alerts during surgery 1 Apply the return electrode to the patient 2 the electrosurgical generator to coag spray or coag fulgurate the highest voltage mode depending upon the generator and set up the power level to 80 W 50 W with ConMed Aspen Excalibur spray 3 Next in the sterile field Connect the instrument the AEM Cord so that the tip does not touch any other object Key the generator using the foot switch for approximately seconds Verify that the power indicator on the generator does illuminate and that there are no AEM Monitor alerts Repeat this test on each AEM instrument 4 Reset the power setting to
63. is reached Proper setup sequence including detection of REM pad AEM Monitor provides visual and audible indication of bipolar current not likely to be affected by the adapter 02087 001 7 9 Technical Specifications Compatible Products For successful operation the AEM Monitor must be used with a set of compatible products This includes an electrosurgical generator with contact quality monitor a return electrode an active electrode active cable and trocar cannula Electrosurgical Generators The AEM Monitoring System is designed to work with the following electrosurgical generators in monopolar mode Each is equipped with a contact quality monitoring circuit for the return electrode Electrosurgical EM2 EM2 A Generator ConMed ARM equipped 115 V models Preferred Use ES9005A AEM Cord Use ES9005A AEM Cord Adapter with ES9007 wiit Extender Adapter or System 5000 2500 Extender Adapter or pier ES9015 Universal Adapter ES9015 Universal with ConMed mountin Adapter with ConMed 9 adapter mounting adapter Preferred Use ES9005 AEM Excalipui Adapter or ES9015 Universal Adapter Preferred Use ES9005 AEM Cord Sabre 2400 Not recommended Adapter with ES9007 Extender Adapter or ES9015 Universal Adapter Preferred Use ES9005 AEM Cord Adapter or ES9015 Universal Adapter Sabre 180 Not tested with 45cm instruments z EM
64. ive non condensing Atmospheric Pressure Operating Storage and Transport 50 110 kPa 02087 001 7 5 Technical Specifications Standards and IEC Classifications Class Equipment per IEC 60601 1 EN 60601 1 Protection against electrical shock is provided by connection of accessible conductive parts to the protective ground conductor in such a way that they cannot become live in the event of a failure of basic insulation Type CF Equipment per IEC 60601 1 EN 60601 1 The Active Electrode Monitor provides a high degree of protection against electrical shock particularly regarding allowable leakage currents and has a CF type isolated floating applied part N 9 Caution Type CF equipment with Protective Earth defibrillator protection Ground Notice ORDINARY EQUIPMENT IS NOT PROTECTED AGAINST THE INGRESS OF WATER MEDICAL ELECTRICAL EQUIPMENT NEEDS SPECIAL PRECAUTIONS REGARDING EMC AND NEEDS TO BE INSTALLED AND PUT INTO SERVICE ACCORNING TO THE EMC INFROMATION PROVIDED HEREIN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT CAN AFFECT MEDICAL ELECTRICAL EQUIPMENT Electromagnetic emissions and immunity per IEC 60601 1 2 EN 60601 1 2 Manufacturer s declaration electromagnetic emissions EN 60601 1 2 2002 Table 201 The Encision Model EM2 series AEM Monitor and accessories are intended for use in the electromagnetic environment specified below The customer or user of the equipment should assure that i
65. l the fuse drawer Check the power entry module and its cable connections if faulty contact service center Test switch if faulty replace power switch Measure line voltage at input terminals on J1 of power supply If the line voltage is not present replace AC power cable Check the power supply s output voltages at power supply s J2 Pins 2 and 4 are ground Pin 1 15 0 1V Pin 3 5 27 05V Pin 5 15 0 1V If any voltage is incorrect adjust or replace power supply Check and reseat all internal connections Turn on and measure the power supply voltages at J4 on the ESM Main Board If any voltage is incorrect replace DC power cable 4 1 Troubleshooting Situation The self test function POST did not take place when power was turned on Power On indicator is on Electrosurgical generator remains in alarm state AEM Cord indicator is on Possible Cause Malfunctioning power supply Internal cables loose disconnected or malfunctioning ESM Main Board malfunction Front Panel malfunction Poor connection of the cord to the shield or Active Electrode Monitor Malfunctioning cord Malfunctioning connection to ESM Main Board Recommended Action Check the power supply s output voltages at power supply s J2 Pins 2 and 4 are ground Pin 1 15 0 1V Pin 3 5 27 05V Pin 5 15 0 1V If any voltage is incorrect adjust or replace the power s
66. l fast 2kV for power 2kV for power Mains power quality should 30 dip in Ur for 25 cycles lt 5 gt 95 dip in Ur for 5 sec 30 dip in Ur for 25 cycles lt 5 295 dip in 5 230VAC 50Hz and 110VAC 50Hz transient burst supply lines supply lines be that of a typical IEC 61000 4 4 1kV for 1kV for commercial or hospital input output input output environment lines lines Surge 1kV line s 1kV lines s to Mains power quality should IEC 61000 4 5 line s line s be that of a typical 2kV line s to 2kV lines s to commercial or hospital earth earth environment Voltage dips lt 5 7 lt 5 Ur Mains power quality should Short gt 95 dip in gt 95 dip in be that of a typical Interruptions and Ur for 0 5 Ur for 0 5 commercial or hospital voltage variations cycle cycle environment If the user of on power supply 40 U 40 Ur 15 series input lines 60 dip in Uz 60 dip in Ur WOMmOr anc accessories X IEC 61000 4 11 52 5 bed 5 5 requires continued operation during power mains 70 70 interruption it is recommended that the Model EM2 series AEM Monitor and accessories be powered from an uninterruptible power supply or a battery Power frequency 50 60Hz magnetic field IEC 61000 4 8 3 A m 50 and 60Hz 3 Power frequency magnetic fields should be at levels characterist
67. l shows an indication when the electrosurgical generator is activated return the unit for repair Connect the electrosurgical generator bipolar output to the Bipolar Generator receptacle using 2 banana cords Short the Bipolar Accessory receptacle with another banana cord Set the bipolar output power to approximately 3 watts Remove remote connector and short pins 1 amp 2 in the remote connector receptacle If the front panel bar graph still shows an indication when the electrosurgical generator is activated return the unit for repair Measure the resistance between pins 1 amp 2 of the remote display s plug If 22 ohms replace the End Point Monitor Remote unit Troubleshooting Situation End Point Monitor Remote Display does not indicate when plugged into the AEM Monitor and the front panel display works properly when the plug is removed 4 12 Possible Cause Defective EPM Main Board Internal cables loose disconnected or malfunctioning Defective End Point Monitor Remote unit Recommended Action Remove the remote connector Measure the supply voltage between pins 7 ground amp 4 of J3 Connect the electrosurgical generator bipolar output to the Bipolar Generator receptacles using 2 banana cords Short the Bipolar Accessory receptacles with another banana cord Set the bipolar output power to cause an indication in the upper half of the scale Activate the electrosurgical generator and
68. le for the return electrode Inhibit Adapter Extension ordered separately as needed Customizes fit with various ESU return electrode receptacles End Point Monitor Display Indicates the intensity of current flow BIPOLAR GENERATOR Receptacles The bipolar jumper cord connects to this receptacle and to the electrosurgical generator BIPOLAR ACCESSORY Receptacles Connects bipolar accessories to the AEM Monitor 02087 001 Rear Panel Controls Indicators and Receptacles er ETLLISTED g MEDICAL ELECTRICAL us EQUIPMENT CONFORMS Intertek 570 60601 1 3181965 WARNING Replace fuse as marked ENCISION HIGH LOW VOLUME CONTROL VOLUME CONTROL 02087 001 END POINT MONITOR REMOTE DISPLAY RECEPTACLE Connects the End Point Monitor Remote Display EMR to this receptacle VOLUME CONTROL Switch Switches between high output low output or off POWER ENTRY MODULE The power cord provided with the AEM Monitor connects to this receptacle Fuse drawer is above the connector Controls Indicators and Receptacles This page intentionally left blank 2 4 02087 001 Setup and Tests 3 Setup and Tests Setup of the AEM Monitoring System Monopolar MOUNTING Mount the AEM Monitor under the electrosurgical generator so the adapter cable reaches the return electrode connector The AEM Monitor is supplied with f
69. like this RETURN ELECTRODE RETURN ELECTRODE Return Electrode ii 02087 001 Foreword Warnings and Cautions Please refer to the manual of your electrosurgical generator for applications information including warnings and precautions regarding its use before proceeding further Explosion Fire and Shock Hazards EXPLOSION HAZARD DO NOT USE ELECTROSURGERY IN THE PRESENCE OF FLAMMABLE ANESTHETICS FIRE EXPLOSION HAZARD THE FOLLOWING SUBSTANCES WILL CONTRIBUTE TO INCREASED FIRE AND EXPLOSION HAZARDS IN THE OPERATING ROOM e FLAMMABLE SUBSTANCES SUCH AS ALCOHOL BASED SKIN PREPPING AGENTS AND TINCTURES e NATURALLY OCCURRING FLAMMABLE GASES WHICH MAY ACCUMULATE IN BODY CAVITIES SUCH AS THE BOWEL OXYGEN AGENTS SUCH AS NITROUS OXIDE N20 ATMOSPHERES THE SPARKING AND HEATING ASSOCIATED WITH ELECTROSURGERY CAN PROVIDE AN IGNITION SOURCE OBSERVE FIRE PRECAUTIONS AT ALL TIMES WHEN USING ELECTROSURGERY IN THE SAME ROOM WITH ANY OF THESE SUBSTANCES OR GASES PREVENT THEIR ACCUMULATION OR POOLING UNDER SURGICAL DRAPES OR WITHIN THE AREA WHERE ELECTROSURGERY 15 PERFORMED FIRE HAZARD DO NOT USE EXTENSION CORDS FIRE HAZARD FOR CONTINUED PROTECTION AGAINST FIRE HAZARD REPLACE FUSES ONLY WITH THE SAME TYPE AND RATING FIRE HAZARD ELECTROSURGICAL ACCESSORIES THAT ARE ACTIVATED OR HOT FROM USE CAN CAUSE A FIRE DO NOT PLACE THEM NEAR OR TOUCHING FLAMMABLE MATERIALS SUCH AS GAUZE OR SURGICAL DRAPES ELECTRIC SHOCK
70. measure the voltage between 7 ground and pin 5 amp 60fJ3 If the voltage difference is gt 0 1 and the supply voltage gt 5 20V return the unit for repair Remove the remote connector Measure the supply voltage between pins 1 amp 4 of the remote connector receptacle Connect the electrosurgical generator s bipolar output to the Bipolar Generator receptacles using 2 banana cords Short the Bipolar Accessory receptacles with another banana cord Set the bipolar output power to cause an indication in the upper half of the scale Activate the electrosurgical generator and measure the voltage between pin 1 ground and pin 2 amp 3 of the remote connector receptacle the voltage difference is gt 0 1V and the supply voltage gt 5 20V return the unit for repair If the above steps have failed replace the End Point Monitor remote unit 02087 001 Principles of Operation 5 Principles of Operation The AEM Monitor is divided into two separate functional parts the AEM Monitor portion and the End Point Monitor portion The implementation for each of these functions is independent of the other with the exception of the power supply and enclosure Theory of Operation AEM Monopolar The AEM Monitoring System enhances safety by detecting insulation breakdowns and blocking stray currents that may not be detected by the surgeon during electrosurgical procedures Indicators identify Set up and Operative
71. mmends that this test be performed once per year 1 Connect the End Point Monitor to any compatible electrosurgical generator with a continuously adjustable output not digital in series with a noninductive load resistor between 50 ohms and 200 ohms and a reference meter 2 reference meter would have a true RMS response a band width of at least 10 MHz and an accuracy of 196 3 Agreement between the End Point Monitor and the reference meter should be within 10 of full scale with currents between 600 mA and 1000 mA Cleaning ELECTRIC SHOCK HAZARD ALWAYS UNPLUG THE AEM MONITOR BEFORE CLEANING NOTE CLEAN MONITOR WHEN NEEDED 1 Turn off the AEM Monitor 2 Disconnect all accessories 3 Follow the procedures approved by your institution or use a validated infection control procedure 4 Use a mild cleaning solution or disinfectant and a damp cloth to thoroughly wipe all outside surfaces and the power cord 02087 001 3 9 Setup and Tests 3 10 Notice DO NOT ALLOW FLUIDS TO ENTER THE CHASSIS DO NOT CLEAN THE AEM MONITOR WITH ABRASIVE CLEANING OR DISINFECTANT COMPOUNDS SOLVENTS OR OTHER MATERIALS THAT COULD SCRATCH THE PANELS OR DAMAGE THE UNIT DO NOT STEAM STERILIZE THE AEM MONITOR Storing the AEM Monitor The AEM Monitor should be stored within these temperatures and humidities Temperature 13 to 158 F 25 to 70 C Humidity 5 to 95 relative noncondensing If you store the AEM Monitor at
72. mmeter to aid in determining the end point of bipolar electrosurgical desiccation Desiccation is a process whereby heat is dissipated in tissue and the electrolytic fluid is driven away As desiccation takes place the electrical impedance of the tissue and the flow of current changes A bar graph displays the current calibrated in tenths of an ampere As the current changes the frequency of clicks changes Use the End Point Monitor in conjunction with visual tactile temporal and aural information observed during surgery The surgeon must use all the information presented and interpret it with reference to experience to determine that desiccation is satisfactorily completed Thus it is important not to draw conclusions about the completion of desiccation from the indications of the End Point Monitor alone Circuit Operation Bipolar The Block Diagram shown on page 9 shows several functional blocks Each block shown in a dotted enclosure will show how the subfunctions are grouped in the current implementation The circuit descriptions of each of these blocks are described in this section RMS to DC Convertor The ESU waveforms used vary over a wide range of shapes Thus the heating value of the current or RMS is the signal conversion method of choice This allows the ammeter display to read a value which is closely related to the surgical effect the surgeon is seeking T1 in combination with R4 and R5 provide voltage proportional
73. n CONNECT THE POWER CORD TO A WALL OUTLET HAVING THE CORRECT VOLTAGE OTHERWISE PRODUCT DAMAGE MAY RESULT 1 Connect the AEM Monitor power cord to a wall receptacle with the proper voltage SELF CHECK 2 Turnonthe AEM Monitor The system completes an automatic self check All of the visual indicators illuminate and two beeps are heard If this is not the case please refer to the troubleshooting section Caution DO NOT USE THE AEM MONITOR UNLESS THE SYSTEM PROPERLY COMPLETES THE AUTOMATIC SELF CHECK OTHERWISE AEM FUNCTIONS MAY NOT BE OPERATIVE INHIBIT ADAPTER Notice THE FOLLOWING REQUIRES THAT THE ELECTROSURGICAL GENERATOR MEET THE CONTACT RESISTANCE CRITERIA REFER TO THE INSTRUCTIONS FOR THE ELECTROSURGICAL GENERATOR THE RETURN ELECTRODE USED FOR THE TESTING MUST SATISFY THE ELECTROSURGICAL 5 CONTACT QUALITY MONITOR EITHER PLACE THE PAD ON THE SKIN OR ADD RESISTANCE TYPICALLY 15 OHMS BETWEEN THE RETURN ELECTRODE WIRES AT THE PANEL 3 Connect the AEM Monitor inhibit adapter to the return electrode receptacle of the electrosurgical generator having compatibility with the AEM system 4 Connect a return electrode to the AEM Monitor inhibit adapter Verify the amber return electrode light turns off AEM CORD ADAPTER DO NOT TOUCH CENTER PIN OF AEM CORD ADAPTER DURING SET UP IT MAY BE ACTIVE IF SETUP INSTRUCTIONS ARE NOT CORRECTLY FOLLOWED 5 Plug the cylindrical end of the AEM Cord Adapter
74. ock diagram is found in Section 10 Drawings and Schematics may be requested by contacting Encision Technical Support 303 444 2600 Both of the conductivity monitors operate in the same way 02087 001 Principles of Operation p109 WAV uone nsu Apeoy SJO EOIpu JenstA YOLINOW WAV WVSHOVIQ unes JOUN AWAHONPUOD Joje19uoac c EE ys s 01 yams su s Mo E OL 5 5 02087 001 Principles of Operation 5 6 The monitor circuitry includes U1A and the surrounding components and the optical isolator IS01 Resistors R8 and R10 form one leg of a bridge and R9 R72 and the external circuit resistance form the other leg of the bridge The amplifier in U1A functions as a null detector When the external circuit resistance is less than the null point the amplifier output at pin 1 will be high allowing all of the current out of R1 to flow through the diode of the optical isolator When the external circuit resistance is greater than the null point the amplifier shunts all of the current out of R1 around the diode When the optical isolator diode is conducting the isolator transistor is also conducting which pulls the output voltage to near 5 volts
75. or Use Care Accessories Instructions for Use Care This section is intended to provide the user with an area to add the Instructions for Use Care These instructions are provided with the accessories are for reference only and are subject to change without notice THE AEM MONITOR IS TO BE USED WITH ENCISION ACCESSORIES INCLUDING ENDPOINT MONITOR REMOTE DISPLAY AEM AEM CORD ADAPTER UNIVERSAL ADAPTER BIPOLAR JUMPER CORD BIPOLAR INSTRUMENT CORDS AEM HANDLE ASSEMBLY REUSABLE AND DISPOSABLE INSERTS DISPOSABLE SHEATH FIXED TIP ELECTRODES SUCTION IRRIGATION ELECTRODES DISPOSABLE ELECTRODES AND HAND CONTROL HANDPIECES AC INPUT CORD HOSPITAL GRADE 120V 15 4 6 M OR 220 240 10 3 M OR ENCISION APPROVED COMPATIBLE ACCESSORIES USE OF OTHER ACCESSORIES OR CABLES MAY RESULT IN INCREASED EMC EMISSIONS OR DECREASED IMMUNITY CONTACT CUSTOMER SERVICE AT 303 444 2600 FOR CURRENT CATALOG OR GO TO WWW ENCISION COM 02087 001 1 Accessories Instructions for Use Care This page intentionally left blank A 2 02087 001 Introduction 1 Introduction Congratulations on your purchase of the AEM Monitor This is state of the art technology that dynamically manages and monitors stray monopolar current Caution THE AEM SYSTEM IS DESIGNED TO SAFELY DELIVER ELECTROSURGICAL ENERGY AND TO PREVENT INJURY CAUSED BY INSULATION FAILURE AND CAPACITIVE COUPLING THE ENCISION AEM SYSTEM IS NOT INTEN
76. r to comply with any of the return procedures specified below or v damaged by excessive current temperature physical stress or other deviation from the applicable environmental specifications Limitation of Remedies ENCISION s sole obligation and Buyer s exclusive 02087 001 remedy for any breach of warranty is limited to the repair or replacement at Encision s option of any warranted product that is returned to ENCISION in its standard shipping container or properly packed in accordance with ENCISION s packing procedures freight prepaid where ENCISION s examination shows the product to have failed under normal use If ENCISION s examination discloses that the returned product is not defective within the terms of this warranty Buyer shall be subject to a 200 00 charge per individual product for testing expenses incurred by ENCISION and the product will be returned to Buyer freight collect Such repair or replacement and reshipment at ENCISION s expense will be Buyer s sole and exclusive remedy for such defect ENCISION will pay shipping charges for the repaired or replaced from ENCISION s factory to Buyer s location notwithstanding the foregoing Buyer ships any product to ENCISION s factory freight collect then ENCISION shall ship the repaired or replaced product freight collect 9 3 Warranty Procedures Buyer shall request authorization from ENCISION prior
77. rcuit Operation Monopolar r ars 5 4 Theory of Operation End Point Monitoring System 5 8 Circuit Operation Bipolar es 5 8 6 Surgical Use Before Surgery 6 1 Monopolar nave 6 2 Checking the AEM Monitoring 6 3 Bip lar CI GaSe 6 4 Checking the End Point Monitoring System 6 5 General 2222440404405 nennen nenne 6 6 Responding to Monitor Alarms 4 22 6 7 Preparing the AEM Monitor for 6 8 02087 001 i Contents Page 7 Technical Specifications Operating Modes AEM Monitoring a aa 7 1 Functional Characteristics 7 2 Indicators and Alert 7 3 Connectors and Cables 7 3 Electrical Characteristics ca 7 5 Dimensions and Weight rer rer be seen Reni 7 5 Environmental 7 5 Standards and IEC
78. rial and workmanship under normal use and service as specified in ENCISION s product manuals and Instructions for Use provided with such product for the period of AEM Monitors 1 year from date of shipment to Buyer ninety 90 days from the date of shipment to Buyer of any repair reconditioning or replacement thereof whichever is longer Instruments and Accessories as stated in the applicable Instructions for Use This warranty shall run in favor of Buyer only and is not enforceable by any other person or entity Disclaimer THE EXPRESS WARRANTIES SET FORTH IN THIS AGREEMENT ARE IN LIEU OF AND BUYER HEREBY EXPRESSLY WAIVES ALL OTHER GUARANTEES AND WARRANTIES OF ANY KIND WHETHER EXPRESS IMPLIED OR STATUTORY INCLUDING WITHOUT LIMITATION MERCHANTABILITY FITNESS FOR PARTICULAR PURPOSE NON INFRINGEMENT OR BY SAMPLE AND ALL SUCH OTHER WARRANTIES ARE HEREBY DICLAIMED AND EXCLUDED BY ENCISION THE SOLE AND EXCLUSIVE REMEDY FOR BREACH OF ENCISION S WARRANTY OF THE PRODUCTS SHALL BE AS STATED HEREIN Exclusions The express warranty set forth above specifically excludes and does not apply to defects i caused through no fault of ENCISION during shipment to or from Buyer ii caused by modifications or alterations made to the products by Buyer or any third party iii caused by unauthorized repair or maintenance performed on the products by Buyer or any third party iv caused by the failure of Buye
79. stomer number telephone number department address city state and zip code model number serial number description of the problem D CL CL do type of repair to be done Returning the Monitor for Service If you are returning the monitor for service clean the monitor then ship it to the Encision Service Center Cleaning 1 Follow the procedures approved by your institution or use a validated infection control procedure 2 Use amild cleaning solution or disinfectant and a damp cloth to thoroughly wipe all outside surfaces and the power cord Notice DO NOT ALLOW FLUIDS TO ENTER THE CHASSIS DO NOT CLEAN THE AEM MONITOR WITH ABRASIVE CLEANING OR DISINFECTANT COMPOUNDS SOLVENTS OR OTHER MATERIALS THAT COULD SCRATCH THE PANELS OR DAMAGE THE UNIT DO NOT STEAM STERILIZE THE AEM MONITOR 02087 001 9 1 9 2 Shipping Monitor Be sure the monitor is completely dry before you pack it for shipment Package the monitor in its original shipping container if available Ship the monitor prepaid to the Encision Service Center Service Center Encision Inc 6797 Winchester Circle Boulder Colorado 80301 3513 USA 303 444 2600 www encision com 02087 001 Policy and Limited Warranty Express Warranty ENCISION hereby warrants to Buyer that products purchased hereunder shall be free from defects in mate
80. t is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The Model EM2 series AEM Monitor CISPR 11 and accessories uses RF energy only for its internal function Therefore its RF emissions are very low and not likely to cause any interference with nearby electronic equipment RF emissions Class A The Model EM2 series AEM Monitor CISPR 11 and accessories is suitable for use in Harmonic emissions Class A all establishments other than domestic IEC 61000 3 2 and those directly connected to the public low voltage power supply Voltage fluctuations Complies network that supplies building used for flicker emissions domestic purposes IEC 61000 3 3 7 6 02087 001 Technical Specifications Manufacturer s declaration electromagnetic immunity EN 60601 1 2 2002 Table 202 The Encision Model EM2 series AEM Monitor and accessories are intended for use in the electromagnetic environment specified below The customer or user of the equipment should assure that it is used in such an environment IEC 61000 4 2 Immunity test IEC 60601 test Compliance Electromagnetic level level environment guidance Electrostatic 6 contact 6 kV contact Floors should be wood discharge ESD 8 kV air 8 kV air concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrica
81. tions All specifications are subject to change without notice Operating Modes AEM Monitoring POST Mode The POWER ON SELF TEST function POST activates each time you turn on the AEM Monitor after the monitor has been OFF for 30 seconds In POST each of the indicators illuminates for six seconds and two tones sound Monopolar Operating Mode The AEM Monitor detects improper setup conditions and detects operative faults by providing a monitored pathway for the current which is flowing from the shield to the patented return electrode Fault conditions are indicated on the front panel and the electrosurgical generator is signaled to disable its output Operative faults also generate an audible alarm Bipolar Operating Mode The AEM Monitor measures the RF current flowing between the elements of a bipolar accessory A number of segments on the display illuminate corresponding to the magnitude of current flowing between the tines of the accessory The indicated current range is 0 1 A to 1 1 The AEM Monitor clicks at a rate proportional to the indicated current and the click volume is adjustable to high low and off A remote visual display may be plugged into the monitor and placed in a convenient viewing position 02087 001 7 1 Technical Specifications Functional Characteristics Monopolar Setup Fault Detection If the shield or return electrode are disconnected causing a setup fault a yellow indicator illuminates to identi
82. to the instantaneous electrosurgical current U1 provides a heating root mean squared conversion of this signal to U2 which amplifies and scales the signal to a level which is appropriate to drive the display Gain calibration is inherent and controlled by the precision devices U1 and U2 in combination with 196 resistors R 7 9 10 11 The offset is set by R13 02087 001 Principles of Operation YOLINOW WAV INd3 Jayeads ayey JIL sisseuoS Ae dsiq J udeJc seg Jejodig 5 9 02087 001 Principles of Operation 5 10 Tick Rate Generator U2C and U4D form a current source converting the input voltage signal to a current signal current mirror comprised of U4C D refers the current to the 15V supply U3 is an oscillator whose frequency is dependant upon the charging current applied to C21 The discharge of C21 is through R24 resulting in discharge time short compared to the charge time U4A and Q1 form an amplifier to drive the speaker from the oscillator output The short discharge of C21 causes a tick to be heard from the speaker Bar graph Display LED bar graphs U1 3 form 30 segment display U4 6 ar
83. tor are functional 02087 001 6 5 Surgical Use General Precautions Return Electrode AEM MONITORING IS INTENDED FOR USE ONLY WITH ELECTROSURGICAL GENERATORS INCORPORATING CONTACT QUALITY MONITORING IN CONJUNCTION WITH A DUAL PAD TYPE RETURN ELECTRODE REFER TO MANUFACTURER S INSTRUCTIONS Active Accessories THESE DEVICES HAVE BEEN SPECIFICALLY DESIGNED FOR USE IN ELECTROSURGERY DO NOT USE FOR OTHER PROCEDURES DO NOT WRAP ACCESSORY CORDS AROUND METAL OBJECTS WRAPPING CORDS AROUND METAL OBJECTS MAY INDUCE CURRENTS THAT COULD LEAD TO SHOCKS FIRES OR INJURY THE ELECTRODE TIP MAY REMAIN HOT ENOUGH TO CAUSE BURNS AFTER THE ELECTROSURGICAL CURRENT IS DEACTIVATED WHEN NOT IN USE PLACE ACCESSORIES IN A CLEAN DRY NONCONDUCTIVE AND HIGHLY VISIBLE AREA NOT TOUCHING THE PATIENT INADVERTENT CONTACT WITH THE PATIENT MAY RESULT IN BURNS INADVERTENT ACTIVATION OR MOVEMENT OF THE ACTIVATED ELECTRODE TIP OUTSIDE THE FIELD OF VISION MAY RESULT IN INJURY TO THE PATIENT USE THESE INSTRUMENTS ONLY UNDER CONDITIONS THAT ASSURE ADEQUATE VISUALIZATION ELECTRODES ARE TOUCHING OTHER INSTRUMENTS DO NOT ACTIVATE THEM BECAUSE UNINTENDED TISSUE DAMAGE MAY OCCUR CONTACT OF THE ACTIVE ELECTRODE WITH ANY METAL SUCH AS HEMOSTATS AND CLAMPS WILL GREATLY INCREASE CURRENT FLOW AND CAN RESULT IN UNINTENDED BURN INJURY WHEN USING LAPAROSCOPIC INSTRUMENTATION WITH METAL CANNULAS THE POTENTIAL EXISTS FOR ABDOMINAL WALL BURNS TO OCCUR IN
84. trode and a metallic cannula are closely spaced conductors and they form a capacitor which can conduct radio frequency current Testing has shown that 5 to 40 of the power indicated on the electrosurgical generator may be delivered from a metallic insulated trocar sheath to the patient s tissues This amount of power is enough to cause a serious burn quickly Capacitively Coupled Energy to Abdominal Wall Cannula Metal cannula with Active Electrode insulated outer surface AEM instruments in conjunction with an AEM Monitor properly connected to the electrosurgical generator ESU continuously monitor and dynamically manage stray energy insulation failure and capacitive coupling in zones 2 amp 3 AEM shielding does not cover zone 1 which the surgeon should keep in view during instrument activation 02087 001 Principles of Operation Protective Shield Primary Insulation Layer Outer Insulation Active Electrode Element The AEM instruments incorporate a layered design AEM instruments are shielded and monitored to prevent stray electrosurgical burns along the shaft of the instrument caused by insulation failure or capacitive coupling The protective shield built into all AEM instruments provides a neutral return path for capacitively coupled energy and protection from insulation failure The shield is continuously monitored during surgery which provides continuous assurance of the integrity of the instrument Ele
85. trode receptacle of the electrosurgical generator with a contact quality monitoring system ARM Connect a return electrode to the AEM Monitor inhibit adapter Plug the cylindrical end of the AEM Cord Adapter into the ESU plug the other end into the AEM Cord receptacle on the AEM Monitor Connect an AEM cord with an AEM instrument to the AEM Cord Adapter at the ESU Verify that the alarm indicators are off and the Ready indicator illuminates on the AEM Monitor Turn on the electrosurgical generator and enable its contact quality monitoring system It should be in its normal operational state Disconnect the AEM cord from the AEM Cord Adapter at the ESU Verify that the following occurs AEM Monitor AEM Cord indicator illuminates AEM Monitor Ready indicator extinguishes The contact quality monitoring system ARM on the electrosurgical generator is in the ready state not alarming Reconnect the AEM cord to the AEM Cord Adapter at the ESU Verify that the following occurs The AEM Monitor AEM Cord indicator extinguishes The AEM Monitor Ready indicator illuminates The contact quality monitoring system ARM on the electrosurgical generator is in the ready state not alarming Return Electrode Connect and Disconnect Verify that the alarm indicators are off and the Ready indicator illuminates on the AEM Monitor Disconnect the return electrode from the AEM Monitor inhibit adapter Verify that the
86. upply Check and reseat all internal connections Turn on and measure the power supply voltages at J4 on the ESM Main Board If any voltage is incorrect replace the DC power cable Turn the power switch Off for 30 seconds and then turn On If the problem persists return the unit for repair If the above steps have failed return the unit for repair Disconnect and reconnect the cord connection to the instrument and the cord connection to the Active Electrode Monitor Connect the cord to the instrument and put the probes of an ohm meter to the pin sockets in the Active Electrode Monitor AEM cord connector If the resistance is gt 4 Ohms replace the cord Short the pins in the AEM Cord receptacle on the front panel If the indicator doesn t go out remove the cover and short pins 1 amp 2 of J1 If the indicator goes out replace the shield connector assembly 02087 001 Situation continued Electrosurgical generator remains in alarm state Return Electrode indicator is on 02087 001 Possible Cause Malfunctioning ESM Main Board Malfunctioning ESM Display Board Improper return electrode Dual Electrode pin is not being detected Malfunctioning connection to ESM Main Board Defective ESM Main Board Defective ESM Display Board Troubleshooting Recommended Action Remove the front panel connection to the ESM Main Board at J2 and connect a voltmeter shunted with

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