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EM2+E (220V) AEM® Monitor

1. qaa A A 4 1 5 Principles of Operation Theory of Operation AEM Monopolar 2222 5 1 Circuit Operation 3 2 5 4 Theory of Operation End Point Monitoring System 5 9 Circuit Operation Bipolar s 5 9 03614 002 Table of Contents Page 6 Surgical Use Before Surge saa adad a a amad n AA TA aaa ANG 6 1 Monobolar S rgery a u dang anganan iiini gagan 6 2 Checking the AEM Monitoring 5 6 3 BIpDOlar SUrg rnyau y an ARADA AAA 6 4 Checking the End Point Monitoring System 00ee0e00000000e 222 6 5 General 6 6 Responding to Monitor Alarms 6 7 Preparing the AEM Monitor for Reuse s s 6 8 7 Technical Specifications Operating Modes AEM 22 7 1 Functional Characteristics A u A s s sss 7 2 Indicators and Alert Functions s s ss s anana e nenen eaaa aane nenen 7 2 Connectors and
2. 6 eaaa aane nenanem nanam anan anan aa nane ene ss eaaa anawa 7 3 Electrical Characteristics ccccssssssssssscssecssessssscssscssccssssesscesscesnscsnscesecesscssscsssseesseesneesneesssess 7 5 Dimensions and Weight 0000000e 000000000000 000000 ea aaa 0000 maea eaaa aan naa aee 7 5 Environmental Characteristics 2222 eaaa eaaa sss 7 5 Standards and IEC Classifications s 7 6 Compatible Products s ss s a aaa au s s es sss 7 10 8 Replacement Procedures 2225 8 1 9 Repair Policy amp Procedures Obtaining a Return Authorization 6 5 6 l 9 1 Returning the Monitor for Service 2 9 1 Limited 9 3 10 Service Parts u a 10 1 Service Center Encision Inc 6797 VVinchester Circle Boulder Colorado 80301 3513 USA 303 444 2600 www encision com 03614 002 Forevvord 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 t i
3. Dual Electrode pin is not being detected Malfunctioning connection to ESM Main Board Defective ESM Main Board Defective ESM Display Board 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 14V initially and lt 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 Possible Cause Recommended Action Electrosurgical generator remains in alarm state Both Return Electrode and AEM Cord indicators are on See possible causes for both Return Electrode indicator is on and AEM Cord indicator is on See recommended action for both Return Electrode indicator is on and AEM Cord indicator is on Electrosurg
4. Surgical Use Bipolar Surgery End Point Monitoring of the bipolar instrument vvill 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 6 4 NOTICE f you are using the Encision End Point Monitor Remote Display EMR mount the display near the TV monitor or at another location in the vievv 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 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 If supplied attach bipolar jumper cord retainer bracket according to accompanying installation instructions Document 00476 WARNING 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
5. JO UOW JUIO4puy Jejodig 4 MH AUOQ 3 9 WASIS I Jejodig ee a a ee joued Juo1j Aejdsiq ydelg seg AHOSS OV 03614 002 5 10 Principles of Operation Tick Rate Generator U2C and U4D form a current source converting the input voltage signal to a current signal A 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 a 30 segment display U4 6 are 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 03614 002 5 11 Principles of Operation This page intentionally left blank 5 12 03614 002 Surgical Use Before Surgery t is important to mount the AEM Monitor under the electrosurgical generator so the adapter cable reaches the return electrode
6. document 02677 03614 002 3 1 Setup and Tests Povver Cord CAUTION Connect the povver cord to a vvall outlet having the correct voltage Othervvise product damage may result 1 Connect the AEM Monitor povver cord to a vvall receptacle vvith the proper voltage Self Check 2 Turn on the AEM Monitor The system completes an automatic self check All of the visual indicators illuminate and two beeps are heard f 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 Othervvise 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 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 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 WARNING DO NOT TOUCH center pin of aem cord adapter during SET UP It may be ACTIVE if setup i
7. www encision com 9 2 036 14 002 Repair Policy and Procedures Limited Warranty Express VVarranty ENCISION hereby vvarrants to Buyer that products purchased hereunder shall be free from defects in material and vvorkmanship 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 one 1 year from date of shipment to Buyer or 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 alterat
8. 002 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 The reference meter should have a true RMS response a band width of at least 10 MHz and an accuracy of 1 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 3 9 Setup and Tests Cleaning WARNING 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 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 parameters Temperature 13 to 158 F 25 to 70 C Humidity 5 to 95 relative non condensing If you store the AEM Monitor at a temperature that is outside its normal operating range of 50
9. 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 beep 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 03614 002 Principles of Operation Theory of Operation End Point Monitoring System The surgeon may use the End Point Monitor a radio frequency RF ammeter 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
10. 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 03614 002 5 7 Principles of Operation 5 8 AEM Cord is in place while the return electrode 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
11. full wave rectifier with U10 differently amplifying the filtered result yielding a current magnitude signal U9B 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 03614 002 Principles of Operation YOLINOW Wav WSS NYM V IQ Y00189 JOJUOJW MO una MO P109 JOJUOJW QIA 9npuoo Jeued 1401 apoljoajg uman p409 WAV uonernsui Apeoy Jomodle LI tee a 10 291 PU JENSIA SU S jeng aued lJuoigd aleanoy 221 5010 2 OL UINJOY OL yu uun nsul WAV PISIYS OL 5 5 03614 002 Principles of Operation ESM Conductivity Monitors The conduct
12. 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 www encision com 3 10 03614 002 Troubleshooting This troubleshooting guide gives instructions for identifying and correcting malfunctions and responding to alarms Refer to Section 8 if a part needs to be replaced CAUTION Refer all servicing to qualified personnel AEM Monitor Monopolar Situation Possible Cause Recommended Action The Power On Self Test function POST did not take place vvhen povver was turned ON All indicators including the povver ON are not on and no beeps are heard 03614 002 Disconnected povver cord faulty vvall receptacle or faulty povver cord Fuse dravver is open or fuses are blovvn Malfunctioning povver entry module or connections Malfunctioning povver switch Malfunctioning AC Power cable in chassis Malfunctioning power supply Check the power cord connections monitor and wall receptacle Connect the power cord to a functional wall receptacle If 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 Install 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 l
13. to connect or disconnect any cable during power activation 3 8 03614 002 Setup and Tests 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 vvatts depending upon the generator characteristics Touch the tines of the instrument together There should be a smooth registration of the current on the bar graph scale The clicking vvill also change its rate in correspondence vvith the current VVhen performing this check for the first time vvith a particular bipolar generator start at a lovv 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 Mechanical Inspection The AEM Monitor and End Point Monitor require minimal maintenance Encision recommends that the AEM Monitor be inspected by qualified service personnel at least twice a year following the list below WARNING Electric 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 recommends that this test be performed once per year 1 03614
14. 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 following Block Diagram EPM AEM Monitor 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 a voltage proportional 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 1 resistors R 7 9 10 11 The offset is set by R13 03614 002 5 9 Principles of Operation 0 40 uunIoA Aeyds q youl M SISSEU YOLINOW WAV Wd NYM V Q Y00189 40 E1 U C ayey YoLL pseog ulen
15. vvith contact quality monitor a return electrode an active electrode active cable and trocar cannula Electrosurgical Generators Electrosurgical Generator Inhibit Adapter EM2 E 230 V Models Extender ConMed 5000 2500 with adapter plate ES9005A ES9007 X Excalibur X Valleylab Force 2 X Force 405 X Force FX 8 X Force EZ X TNot tested with 45cm Instruments Sales representatives working with customers using this ESU must receive specific training from Encision Technical Support Technical Support will document any training in an Encision training record SIf ES9015 Universal Adapter not being used NOTICE All Electrosurgical Generators ESUs must have contact quality monitoring circuit for return electrodes Cord adapter ES9015 is for hand and foot controlled instruments 59005 59005 is for foot controlled only 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 such as Aspen 3M NDM Valleylab and others 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 or for Encision Inc or licensed by Encision Inc 7 10 03614 002 Replacemen
16. Class A The Model EM2 series AEM Monitor and accessories CISPR 11 are suitable for use in all establishments other than domestic and those directly connected to the public Harmonic emissions Class A low voltage power supply network that supplies IEC 61000 3 2 buildings used for domestic purposes Voltage fluctuations flicker Complies emissions IEC 61000 3 3 7 6 03614 002 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 belovv The customer or user of the equipment should assure that it is used in such an environment mmunity test IEC 60601 test Compliance level Electromagnetic environment level guidance Electrostatic discharge 6kV contact 6 kV contact Floors should be wood concrete ESD 8 kV air 8 kV air or ceramic tile If floors are IEC 61000 4 2 covered with synthetic material the relative humidity should be at least 30 Electrical fast 2kV for power 2kV for power Mains power quality should be transient burst supply lines supply lines that of a typical commercial or 1kV for 1kV for hospital environment IEC 61000 4 4 input output lines input output lines Surge 1kV line s to 1kV line s to Mains power quality should be line s line s that of a typical comm
17. EM Monitor 11 Disconnect the return electrode from the AEM Monitor inhibit adapter Verify that the following occurs The AEM Monitor Return Electrode indicator illuminates The AEM Monitor Ready indicator extinguishes The contact quality monitoring system on the electrosurgical generator signals an alarm 12 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 on the electrosurgical generator no longer signals an alarm 03614 002 855 Setup and Tests 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 13 Setup When using the ES9005 Adapter Connect a miniature alligator clip betvveen the tvvo pins of the AEM Monitor AEM Cord receptacle 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 probe
18. ENLGISIZCNMN AEM Monitor Operator Service Manual li 01 2 3 4 5 6 7 8 9 10 1 AEP CORD NSULAT ON N eni I H BIPOLAR ENDPOINT MONITOR aerun atecmnooe gt vv N s AEM Monitor BIPOLAR ACCESSORY AEMP CORD with Technology 03614 002 ENCISIGN Operator Service Manual AEM Monitor 2 220 240V gal Manufactured by Encision Inc 6797 VVinchester Circle Boulder Colorado 80301 3513 C 1275 Ph 303 444 2600 Fax 303 444 2693 Made in USA Authorized Representative MDSS GmbH Schiffgraben 41 30175 Hannover Germany 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 is a registered trademark of Encision Inc AEM is a registered trademark of Encision Inc REM is a trademark of Covidien Valleylab ARM is a trademark of ConMed Aspen Labs Printed in USA Part Number 03614 002 2011 07 2011 Encision Inc All rights reserved Table of Contents Page Forevvord Indications for User Aa AN DKG i Contraindicatii Nonsena ai Ne A S ga gawan i Conventions Used in This 2222 ii Warnings and Cautions
19. H 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 SUCH 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 03614 002 Service Parts Replacement parts for the AEM Monitor are listed in this section If a part is not listed it is not available CAUTION When Monitor is worn out dispose of per local regulations for electrical equipment For schematics or replacement part information please contact the Encision Service Center 303 444 2600 A C Power Cord 220 240V D C Power Cable Front Panel Fuse 5 x 20 mm 0 5 Amp 230V I F Cable Inhibit Adapter Assy 21 w o Extension Power Supply Three Output Shield Connector Assembly Bipolar Cord Bipolar Cord Bipolar Cord Inhibit Adapter Extension for use with e Conmed Aspen System 2500 5000 03614 002 Contact Encision 00483 001 00638 004 01374 000 00484 000 00652 002 01347 000 01452 000 ES9003 ES9003D ES9004 ES9007 10 1 Service Parts Volume Control To Remote Endpoint Monitor Speaker Three Output Povver Supply AEM Monitor ESM Main Board End Point Monitor EPM Main Board To Electrosurgical To Bipolar To AEM Cord To Inhibit Adapter Generator Bipolar
20. The relay contact is used to place the ESU in normal or inhibit function depending on the results of the AEM Monitor measurements VVhen the contact is opened the AEM Monitor signals the ESU to inhibit because the contact quality monitor vvithin the ESU measures high impedance The adapter also contains a svvitch vvhich is actuated by a feature on the return electrode connector A svvitch activates a setup fault in the presence of the vvrong type of electrode This ensures the connection of the correct type of return electrode A conductivity monitor reads the state of the svvitch ESM Current Monitor To determine the status of electrode insulation the AEM Monitor measures tvvo aspects of the current flovving in the conductive shield that encloses the insulation Criteria are placed on the measurements and the results of the tvvo 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 vvidth must be less than a preset value Currents above this value generate an alert The value at which the alarm generates varies vvith 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 the active electrode is shorted to the shield The T2 current transformer with R14 produces a voltage signal proportional to the shield current U8 forms a
21. ULATION 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 2 6 8 Turn off the AEM Monitor Disconnect all accessories WARNING Electric Shock Hazard Always unplug the AEM Monitor before cleaning 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 03614 002 7 Technical Specifications 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 tvvo tones sound Monopolar Operating Mode The AEM Monitor detects improper setup conditions and detects operative faults by providing a monitored pathvvay for the current vvhich is flovving from the shield to the patented
22. V Pin 3 5 27 O5V 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 gt 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 for repair 4 7 Troubleshooting Situation Possible Cause Recommended Action No audible indication The Volume Control Set the Volume Control svvitch to the up no clicking correct svvitch is in the vvrong positi
23. WARNING 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 like this RETURN ELECTRODE RETURN ELECTRODE Return Electrode i 03614 002 Forevvord 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 WARNING 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 Flammable substances such as alcohol based skin prepping agents and tinctures 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 are
24. a where electrosurgery is 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 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 03614 002 iii Forevvord General Electrosurgical Hazards WARNING 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 povver setting before proceeding vvith surgery Use the lovvest povver setting that achieves the desired surgical effect n 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 electrosurg
25. arada APA AAA d uda ili Symbol Defi ifi l PS z w RA vii A Acces ories a RALAR ag hide vended a qu GN ANGE PA A 1 1 Introduction Unpacking your System a a 1 1 Active Electrode Monitoring u a 1 2 Mo opolar S rgery u d k R 1 2 Bipolar Surge nsiro enia aaa az 1 2 2 Controls Indicators and Receptacles FronePanel s a aa baa A aaa ia 2 1 serah eg ae Rae ADA 2 3 3 Setup and Tests Setup of the AEM Monitoring System Monopolar 3 1 Optional Functional Test for Operating Room before procedure begins 3 3 Checking the AEM Monitoring System Monopolar 3 4 Setup of the End Point Monitoring System Bipolar 3 7 Checking the End Point Monitoring System Bipolar 3 9 Mechanical INSP CtiOn csssssssssssssscssscssecsnscssecssecsssccssecesscesscesscessecsuccsssessscessccsscseaeeeaseesees 3 9 Electricalilnspection sides cosas uqa u usa na cated b 3 9 nana aga sane anaa a aneka nagane ninang kaa 3 10 Storing the AEM Monitor 0e RAR aaa eaaa d d n 3 10 Sevice Center u anan ai gana ia dakan a Ana naa a qaq ngebag an neka naa as 3 10 4
26. at 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 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 Inhibit Adapter green block attached by means
27. ayed 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 C49 and C5 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 5 6 036 14 002 Principles of Operation 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 or arcing to Shield 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 are applied to logic inputs of the PLD U4 at
28. 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 Cannula Abdominal Wall Zone 2 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 03614 002 Principles of Operation Protective Shell Primary Insulation Layer x z 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 Active Conductor Electrosurgical AEM Cord Generator AEM Cord Adapter Inhibit Adapter Shield m AEM nstrument Conductor Return Cable AEM Monitor 1 Detection of Insulation Fail
29. bles 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 AEM CORD Amber Alarm Indicator SETUP FAULT Check the 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 are made and the amber indicator continues to illuminate replace the AEM cord 03614 002 6 7 Surgical Use INSULATION Red Alarm Indicator OPERATIVE FAULT WARNING 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 INS
30. 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 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 inst
31. ceptacles This page intentionally left blank 2 4 03614 002 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 vvith feet spaced for compatibility vvith 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 WARNING 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
32. connector The AEM Monitor is supplied vvith feet spaced for compatibility vvith 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 WARNING Fire Hazard Do not use extension cords Electric Shock Hazard Connect the povver 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 the visual indicators illuminate and two beeps are heard If this is not the case please refer to the Troubleshooting section 03614 002 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 co
33. d return the unit for repair Electrosurgical generator remains in alarm state AEM Cord indicator is on 4 2 Poor connection of the cord to the shield or Active Electrode Monitor Malfunctioning cord Malfunctioning connection to ESM Main Board 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 03614 002 Troubleshooting Situation Possible Cause Recommended Action continued Malfunctioning ESM Main Board Malfunctioning ESM Display Board Remove the front panel connection to the ESM Main Board at J2 and connect a voltmeter shunted vvith 1K ohms to the 15V supply end of C47 and pin U2 16 The voltage should be gt 14V initially and lt 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 Electrosurgical generator remains in alarm state Return Electrode indicator is on 03614 002 Improper return electrode
34. d J2 on the ESM Main Board Replacement Procedures Reinstall Cover 1 2 Repeat the tests that failed Proceed only if all tests pass Slide cover over the chassis Line up the holes in the cover vvith the tapped holes in the chassis Install the six screws previously removed that secure the cover to the 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 1 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 03614 002 Replacement Procedures Inhibit Adapter Replacement 1 2 03614 002 Remove the cover from the AEM Monitor Cut the inhibit adapter cable at the strain relief on the inside of the unit next to the sheet metal and pull the inhibit adapter cable out from the front Disconnect the white locking connector that attaches the inhibit adapter cable to the ESM Main board Mark the color of the wire from the inhibit adapter onto the locking connector With a knife or small screwdriver push the metal pa
35. e 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 Monitoring 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 03614 002 3 7 Setup and Tests WARNING 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 gene
36. e 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 03614 002 Forevvord 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 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 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 03614 002 WARNING 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 o
37. ectrode 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 indicates the same information as the front panel display but when the Encision End Point Monitor Remote Display EMR is plugged into the REMOTE DISPLAY connector the front panel display is inactive Cord Length 15 4 6 meters Duty Cycle Continuous 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 7 2 03614 002 Technical Specifications RETURN ELECTRODE yellovv light Indicates th
38. ed 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 discontinue 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 patient 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 Electrosurgical Unit 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 to electrosurgical generators be made only while the generator is Off or on Standby Use the AEM Monitor onl
39. ercial or IEC 61000 4 5 2kV line s to earth 2kV ine s to hospital environment earth Voltage dips Short lt 5 Ur lt 5 Ur Mains power quality should be Interruptions and voltage variations on power supply input lines IEC 61000 4 11 gt 95 dip in Ur for 0 5 cycle 4096 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 55 59596 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5s Ur 230VAC 50Hz and 110VAC 50Hz that of a typical commercial or hospital environment If the user of the Model EM2 series AEM Monitor and accessories requires continued operation during power mains 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 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 03614 002 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 and accessories are intended for use in the electromagnetic environment specified below The custo
40. ery requires proper placement of the patient return electrode To avoid electrosurgical burns beneath the patient return electrode follovv all directions on the product package for proper return electrode placement and use n some circumstances potential exists for alternate site burns at points of skin contact e g betvveen the arm and the side of the body This occurs when electrosurgical current seeks a path 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 follovving Avoid skin to skin contact points such as fingers touching leg when positioning the patient Place two to three inches of dry gauze between contact points to ensure that contact does not occur 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 th
41. h the active instrument 4 Connect an AEM cord with an AEM instrument to the AEM CORD ADAPTER at the ESU 6 2 036 14 002 Surgical Use Checking the AEM Monitoring System The follovving 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 6 Turn on the electrosurgical generator and enable its contact quality monitoring system t should be in its normal operational state 7 Disconnect the AEM Cord from the AEM CORD ADAPTER at the ESU Verify that the follovving occurs The AEM Monitor AEM CORD indicator illuminates The AEM Monitor READY indicator extinguishes The contact quality monitoring system on the electrosurgical generator alarms 8 Reconnect the AEM Cord to the AEM CORD Adapter at the ESU Reset contact quality monitoring system if necessary Verify that the follovving 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 03614 002 6 3
42. ical generator remains in alarm state Ready indicator is on and all fault indicators are off 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 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 amp 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 8 6 of J1 If gt 2 ohms return the unit for repair 03614 002 Troubleshooting Situation Possible Cause Recommended Action Electrosurgical generator not in alert state during fault The Ready indicator is Off and any of the follovving indicators are also on AEM Cord Return Electrode or Insula
43. ine voltage at input terminals on 11 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 O5V Pin5 15 0 1V If any voltage is incorrect adjust or replace power supply 4 1 Troubleshooting Situation Possible Cause Recommended Action continued nternal cables loose disconnected or malfunctioning 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 The self test function POST did not take place when power was turned on Power On indicator is on Malfunctioning power supply Internal cables loose disconnected or malfunctioning ESM Main Board malfunction Front Panel malfunction 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 O5V 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 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 faile
44. ions 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 Buyer 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 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 If notwithstanding the foregoing Buyer ships any product 03614 002 9 3 Repair Policy and Procedures to ENCISION s factor
45. is seen If the AEM Monitor fails to light the Insulation indicator and deactivate the electrosurgical generator return the unit for service 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 service Blown fuse s on power supply 03614 002 Unknown Replace power supply DO NOT REPLACE FUSES 4 5 Troubleshooting End Point Monitor Bipolar Situation Possible Cause Recommended Action When the power is turned ON all indicators including the povver ON are not on and no beeps are heard 4 6 Disconnected povver cord faulty vvall receptacle or malfunctioning povver cord Fuse dravver is open or fuses are blovvn Malfunctioning povver entry module or connections Malfunctioning povver switch Malfunctioning AC Power Cable in chassis Malfunctioning power supply Internal cables loose disconnected or faulty Malfunctioning ESM Display Board Check the power cord connections Monitor and wall receptacle Connect the power cord to a functional wall 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 fau
46. ith another banana cord Set the bipolar output povver to approximately 3 vvatts Remove remote connector and short pins 1 amp 2 in the remote connector receptacle If the front panel bar graph still shows an indication vvhen 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 gt 2 ohms replace the End Point Monitor Remote unit 03614 002 Troubleshooting Situation Possible Cause Recommended Action Defective EPM Main Board End Point Monitor Remote Display does not indicate vvhen plugged into the AEM Monitor and the front panel display vvorks properly when the plug is removed Internal cables loose disconnected or malfunctioning Defective End Point Monitor Remote unit 03614 002 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 measure the voltage between pin 7 ground and pins 5 amp 6 of J3 If the voltage difference is gt 0 1V and the supply voltage gt 5 20V return the unit for repair Remove the remote connector Measure the supply voltage bet
47. ivity 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 block 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 The monitor circuitry includes U1A and the surrounding components and the optical isolator 1501 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 When the diode is not conducting the transistor is not conducting causing the output voltage to be near ground These transitions are briefly del
48. lty 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 Ifa 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 O5V 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 I F Cable If the above steps have failed return the unit for repair 03614 002 Troubleshooting Situation Possible Cause Recommended Action No bar graph indication 03614 002 End Point Monitor Remote plugged into the End Point Monitor Malfunctioning povver 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 Verify 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 1
49. me 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 allovvable leakage currents and has a CF type isolated floating applied part iv 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 according to the EMC information 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 belovv The customer or user of the equipment should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The Model EM2 series AEM Monitor and accessories CISPR 11 use 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
50. mer or user of the equipment should assure 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 VP 80 MHz to 800 MHz IEC 61000 4 6 150kHz to 80 MHz 150kHz to 80 MHz Radiated RF 3V m 3V m d 1 2 VP 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz 80 MHz to 2 5 GHz d 2 3 VP 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 5 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Ko 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 a Field strengths from fixed transmitter
51. nel Replacement 1 03614 002 Disconnect the front panel cables connected to J1 and J2 on the EPM Main Board Disconnect the front panel cables connected to J1 and 12 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 in Section 10 diagram Save for reinstallation Remove the screw and lock washer which holds the front panel bracket to the chassis shown by arrow 3 in Section 10 diagram 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 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 Section 10 diagram 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 Section 10 diagram Reconnect the front panel cables connected to J1 and J2 on the EPM Main Board Reconnect the front panel cables connected to J1 an
52. nstructions are not correctly followed 5 Plug the cylindrical end of the AEM Cord Adapter into the Electrosurgical Unit ESU plug the other end into the AEM Cord receptacle on the AEM Monitor 3 2 03614 002 Setup and Tests Connect an AEM Cord with an AEM instrument to the AEM Cord Adapter at the ESU Verify that the amber AEM Cord light turns off and the green Ready light is on 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 the AEM instrument s internal insulation is in good condition and can be expected to perform without alerts during surgery 1 2 03614 002 Apply the return electrode to the patient Set the electrosurgical generator to coag spray or coag fulgurate the highest voltage mode depending upon the generator and set up the povver level to 80 VV 50 VV vvith ConMed Aspen Excalibur spray Next in the sterile field Connect the instrument to the AEM Cord so that the tip does not touch any other obiect Key the generator using the foot svvitch for approximately 3 seconds Verify that the power indicator on the generator does ill
53. nstrument Front Panel Assembly Figure 1 Block Diagram AEM Monitor 10 2 03614 002
54. 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 03614 002 7 3 Technical Specifications AEM CORD receptacle on front panel A unique tvvo conductor receptacle that receives the AEM Cord Adapter or Universal 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 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 Povver Receptacle mounted on rear panel UL IEC type receptacle containing two 0 5 A 250V fas
55. on High bar graph indication position Malfunctioning speaker Measure the voltage betvveen ground speaker Volume end of C6 and the end of R22 nearest Control switch and or the board edge If it is lt 4 8 V return the cable unit for repair assuming the ESM Main Board is OK 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 with 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 Malfunctioning EPM Connect the electrosurgical generator Main Board 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 8 036 14 002 Situation Possible Cause Fuzzy Indication on Faulty power supply the bar graph When indicating near the high end of the current scale the bars at the right end of the indication are neither fully on nor off Internal cables loose disconnected or malfunctioning Malfunctioning EPM Display Board or EPM Main Board 03614 002 Troubleshooting Recommended Action Check the p
56. 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 6 6 036 14 002 Surgical Use 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 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 Do not attempt 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 disa
57. ower supply s output voltages at power supply s J2 Pins 2 and 4 are ground Pin 1 15 0 1V Pin 3 5 27 O5V 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 4 9 Troubleshooting Situation Possible Cause Recommended Action Front panel display does not turn off when End Point Monitor Remote is plugged into rear connector Malfunctioning EPM Main Board Internal cables loose disconnected or malfunctioning Malfunctioning End Point Monitor Remote unit 4 10 Connect the electrosurgical generator bipolar output to the Bipolar Generator receptacle using 2 banana cords Short the Bipolar Accessory receptacle vvith another banana cord Set the bipolar output povver to approximately 3 vvatts Remove the remote connector and short pins 6 amp 7 in J3 If the front panel bar graph still shovvs 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 vv
58. 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 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 GAL6001 Logic input signals are buffered by the amplifiers in U6 to ensure proper logic levels The logic output signals are buffered by the amplifiers in U2 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 of the indicators is driven
59. rator Ensure that accessories and adapters are correctly connected and that no metal is exposed 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 WARNING Do not attempt
60. res 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 Cannula Active Electrode Zones 2 amp 3 are likely out of the surgeon s field of view 03614 002 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 Cannula 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 electrode 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
61. 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 flovving betvveen the elements ofa 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 A The AEM Monitor clicks at a rate proportional to the indicated current and the click volume is adiustable to high lovv and off A remote visual display may be plugged into the monitor and placed in a convenient vievving position 03614 002 j 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 identify 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 20 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 el
62. rn 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 customer number telephone number department address city state and zip code model number serial number description of the problem 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 03614 002 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 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 9 1 Repair Policy and Procedures Shipping the 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 VVinchester Circle Boulder Colorado 80301 3513 USA 303 444 2600
63. rt of the contacts down on the white connector Push the contact down and toward the wire Pull the wire after pushing the contact back The contact should pull out of the white connector NOTE Look at the metal contact while removing the correct orientation of the contact is needed to place the new one Insert the inhibit adapter cable from the new inhibit adapter through the hole in the front panel A pair of pliers may be used to pull the cable through Pull only on the strain relief portion of the cable NOTE Squeezing and holding the strain relief will compress the material and make it easier to pull through the front panel The use of alcohol on the strain relief may also help Insert the metal contacts into the white connector in the correct locations Gently pull the wires after all of the contacts have been inserted to insure they are locked into position Attach white connector to the PC board Reattach the cover onto the top of the unit 8 5 Replacement Procedures Push here to remove the contact Push the contact dovvn and tovvard the vvire Bottom vievv of connector Do not disconnect vvhite vvires Black Red Green VVhite Yellovv Verify that the AEM Monitor functions properly per Section 3 of this manual Perform normal electrical safety tests as required per hospital protocols 8 6 03614 002 Repair Policy amp Procedure Obtaining a Return Authorization Number Before you retu
64. rument includes both electrodes A patient 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 control is needed to ensure the correct degree of heating 1 2 036 14 002 Controls Indicators and Receptacles The AEM Monitor front and rear panel features are illustrated and described in this section Front Panel 2 3 4 5 6 7 8 1 AEM CORD INSULATION wy RF AMPERES Kir BIPOLAR AZ I GENERATOR BIPOLAR ENDPOINT MONITOR RETURN ELECTRODE AEM Monitor gt POWER Green Indicator AF Illuminates when power is supplied The power switch is located on the side of the unit B AEM CORD Amber Indicator AEM CORD Illuminates if the AEM Cord is not connected to the Monitor or if the cord is not plugged into the AEM instrument C RETURN ELECTRODE Amber Indicator RETURN ELECTRODE Illuminates if the return electrode is of the wrong type or is not connected D INSULATION Red Indicator INSULATION 1 Illuminates in the event of an internal insulation failure of an AEM Instrument 03614 002 Controls Indicators and Receptacles READY ar23 4 5 6 7 8 9 001 RF AMPERES BIPOLAR ENDPOINT MONITOR O BIPOLAR GENERATOR olo BIPOLAR ACCESSORY 2 2 READY Green indicator Illuminate
65. s betvveen the return electrode vvires at the panel 2 Connect the AEM Monitor inhibit adapter into the return electrode receptacle of the electrosurgical generator vvith a contact quality monitoring system Connect a return electrode to the AEM Monitor inhibit adapter 4 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 5 Connect an AEM cord with an AEM instrument to the AEM Cord Adapter at the ESU 6 Verify that the alarm indicators are off and the Ready indicator illuminates on the AEM Monitor 7 Turn on the electrosurgical generator and enable its contact quality monitoring system It should be in its normal operational state 8 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 on the electrosurgical generator alarms 03614 002 Setup and Tests 9 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 on the electrosurgical generator no longer signals an alarm Return Electrode Connect and Disconnect 10 Verify that the alarm indicators are off and the Ready indicator illuminates on the A
66. s 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 5 Over the frequency range 150 kHz to 80 MHz the field strengths should be less than 3 Vm 03614 002 Technical Specifications Recommended separation distances between portable and mobile RF communications equipment and the Model EM2 series 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 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 communication
67. s 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 the generator at 5 to 10 watts depending upon the generator characteristics 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 Monitor are functional 03614 002 6 5 Surgical Use General Precautions Return Electrode WARNING 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 WARNING These devices have been specifically designed for use in electrosurgery Do not use for other procedures Do not wrap accessory cords around me
68. s J5 and the EPM Main Board s J4 Three Output Power Supply 1 10 11 Remove the screvvs in the upper right and lovver 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 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 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 Reconnect all cable connections to the power supply J1 and J2 03614 002 Replacement Procedures Front Pa
69. s equipment Rated maximum output Separation distance according to frequency of transmitter power of transmitter m W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz D 1 2 P D 1 2 VP D 2 3 NP 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 povver not listed above the recommended distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter vvhere P is the maximum output power rating of the transmitter in vvatts 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 Shield function Detection of insulation breakdown and signal to the Electrosurgical Unit ESU if threshold is reached Proper setup sequence including detection of REM pad The AEM Monitor provides visual and audible indication of bipolar current not likely to be affected by the adapter 03614 002 7 9 Technical Specifications Compatible Products For successful operation the AEM Monitor must be used vvith a set of compatible products This includes an electrosurgical generator
70. s if all conditions have been met for AEM Monitoring System operation AEM CORD Receptacle The AEM cord connects to this receptacle Green inhibit Adapter An adapter that connects to the Electrosurgical Unit ESU return electrode receptacle and has a receptacle 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 03614 002 Rear Panel Controls Indicators and Receptacles ARIPO AN FNDPOINT MONITOR ENCISION 5 XXXXXKX XXXXXXX AX XXX xx HIGH LOW Qm VOLUME CONTROL VOLUME CONTROL 03614 002 A END POINT MONITOR REMOTE DISPLAY Receptacle Connect 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 POTENTIAL EQUALIZATION Terminal A potential equalization conductor connects to this terminal as required by country electrical standards optional 2 3 Controls Indicators and Re
71. s not intended to be a general reference about the use of electrosurgery either in general application or in laparoscopic procedures ndications for Use The Encision AEM Monitoring System is an accessory for use vvith electrosurgical generators and electrodes that is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling The AEM Monitoring System consists of tvvo distinct functions 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 End point monitoring is intended to aid the surgeon in determining the end point of bipolar electrosurgical desiccation Contraindications There are no knovvn 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 Federal USA law restricts this device to sale by or on the order of a physician 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 03614 002 Forevvord Conventions Used in this Manual
72. s that fit into this socket Shield Sockets 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 enabled is in the normal operating state 15 Set the electrosurgical generator with the contact quality monitoring system to 20 Watts in the standard coagulation mode For the ConMed 5000 set the power to 35 Watts in the standard coagulation mode 3 6 03614 002 Setup and Tests 16 Test When using the ES9005 Adapter Activate the electrosurgical generator and touch the alligator clip vvith the pencil electrode lt may be necessary to touch the alligator clip vvith the pencil electrode for a fevv seconds vvith the ConMed 5000 For the ConMed 2450 it may be easier to trigger an insulation fault if the spark is initiated vvhen the pencil is close to the alligator clip When using the ES9015 Adapter Activate the electrosurgical generator and touch the distal end of test probe vvith the pencil electrode lt may be necessary to touch the test probe vvith the pencil electrode for a fevv seconds vvith 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 th
73. t 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 in Section 10 WARNING Electric Shock Hazard 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 a new D C power cable by connecting it to the ESM Main Board s J4 and the three output power supply s J2 03614 002 8 1 Replacement Procedures 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 Install the new I F Cable by connecting it to the ESM Main Board
74. t blow 5 x 20 mm fuses one for each side of the line Povver Cord attached to povver receptacle A 10 3 m long VDE approved power cord 220 240V AC POTENTIAL EQUALIZATION Terminal mounted on rear panel Provided for connecting a potential equalization conductor as required by country electrical standards optional 7 4 03614 002 Technical Specifications Electrical Characteristics nput Power Requirements 220 240 Volt 230 V nominal 220 240 Volts 47 63 Hz Normal current drain 0 2 A Maximum current 0 5A Chassis Source Leakage Current 100 HA maximum Patient Leakage Current Source or sink leakage current is 10 pA maximum Dimensions and VVeight External Dimensions 13 0 33 0 cm vvide x 20 50 8 cm long x 2 5 6 35 cm high does not include feet Feet raise chassis 0 5 1 3 cm Weight 8 0 Ibs 3 63kg Environmental Characteristics Operating Temperature 50 to 122 F 10 to 50 C Storage and Transport Temperature 13 to 158 F 25 to 70 C Operating Storage and Transport Humidity 5 to 95 relative non condensing Atmospheric Pressure Operating Storage and Transport 50 110 kPa 03614 002 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 vvay that they cannot beco
75. tal 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 If 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 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 If any of these are present do not use Failure to observe this precaution may result in injury
76. 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 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 03614 002 Surgical Use 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 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 After successful completion of these step
77. tion nappropriate internal state of the AEM Monitor Malfunctioning electrosurgical generator Malfunctioning connection to ESM Main Board Defective ESM Main Board Malfunctioning ESM Display Board Turn povver svvitch Offfor 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 Electrosurgical Unit 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 If the above steps have failed return the unit for repair AEM Monitor does not detect operative fault Insulation light remains off during fault condition Arc detector failure Short detector failure Set up the AEM Monitor with the electrosurgical generator in the normal manner using a pencil electrode Instead of connecting 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
78. uminate and that there are no AEM Monitor alerts Repeat this test on each AEM instrument Reset the povver setting to 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 Setup and Tests Checking the AEM Monitoring System Monopolar 3 4 The follovving is a quick test of the AEM Monitoring System A failure on any of the follovving 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 Povver On Self Test Function POST 1 POST is activated when the povver is svvitched 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 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 ohm
79. upling 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 to electrosurgical generators be made only while generator is off or on 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 Electrosurgical Unit ESU CAUTION AEM will not function without the use 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 wit
80. ure Return Electrode 2 Protection Against Capacitive Coupling The AEM Monitor measures the currents flowing in the AEM integrated instruments detects faults in the insulation and 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 03614 002 5 3 Principles of Operation Circuit Operation Monopolar 5 4 The follovving Block Diagram ESM AEM Monitor shovvs several functional blocks Each block shovvn in a dotted enclosure vvill shovv hovv the subfunctions are grouped in the current implementation The circuit descriptions of each of these blocks are described in this section ESM Adapter Relay The adapter places the AEM Monitor relay electrically betvveen the return electrode and the electrosurgical unit ESU
81. urn Electrode Catalog Number setup fault Serial Number AEM Cord setup fault Manufacturing Date Bipolar Accessory Manufacturer OB Bipolar Jumper Cord Protective Earth Ground u gt Volume Control Eguiporentiality Q da High OFF Low q Remote Display Jack vii Forevvord This page intentionally left blank viii 03614 002 Accessories Use the AEM Monitor with the following Encision accssories Separate Instructions for Use are provided with the accessories End Point Monitor Remote Display AEM Cord 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 220 240v 10 Ft 3 m Or Encision approved compatible accessories WARNING 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 03614 002 A 1 Accessories This page intentionally left blank A 2 03614 002 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 pre
82. utside 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 accessory 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 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 Forevvord vi 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 unintend
83. vent injury caused by insulation failure and capacitive coupling The Encision AEM system is not intended 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 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 End Point Monitoring Intended to aid the surgeon in determining the end point of bipolar electrosurgical desiccation Unpacking your System The AEM Monitor is shipped in one carton You may receive a secondary carton that contains a power cord Setup Card and Operator Service Manual as appropriate for your country Encision suggests that you store the monitor carton so that it will be available if the need for service arises Carefully unpack the cartons 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 Bipolar Jumper Cord Retainer Bracket Setup Card Operator Service Manual Contact Customer Service at 303 444 2600 to arrange for repair or replacement of any parts damaged from shipping 03614 002 1 1 Forevvord Active Electrode Monitoring Active electrode monitoring technolooy can eliminate the risk of stray electrical energy caused
84. ween 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 pins 2 amp 3 of the remote connector receptacle If 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 Troubleshooting This page intentionally left blank 4 12 03614 002 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 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 procedu
85. y freight collect then ENCISION shall ship the repaired or replaced product freight collect Warranty Procedures Buyer shall request authorization from ENCISION prior 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 BREAC
86. y if the self test has been properly completed Otherwise AEM functions may not be operative 03614 002 Forevvord Electromagnetic Compatibility Hazards CAUTION Use of Accessories transducers and cables other than those specified with the exception of transducers and cables sold by the 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 except as specified herein 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 EMC information provided in the accompanying documents Portable and mobile RF communications equipment can affect medical electrical equipment Symbol Definitions 03614 002 gt FE m 7 4 D E IL 2 N Caution XF Power Consult instructions ray Ready for use Type CF equipment vvith defibrillator protection Insulation operative fault wW 4 Ret

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