Encision EM2+E Operators & Service Manual
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Encision EM2+E Operators & Service Manual

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03614-001

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Summary of Contents for Encision EM2+E

  • Page 1 ® Monitor Operator/Service Manual with AEM ® Technology 03614-001...
  • Page 2 Operator/Service Manual ® Monitor EM2+E (220-240V)
  • Page 3 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 registered trademark of Covidien/Valleylab ARM™ is a trademark of ConMed/Aspen Labs...

  • Page 4: Table Of Contents

    Table of Contents Page Foreword Indications for Use ........................i Contraindications........................i Conventions Used in This Manual..................ii Warnings and Cautions......................iii Symbol Definitions ........................vii Accessories-Instructions for Use/Care ............A-1 Introduction Unpacking your System.......................1-1 Active Electrode Monitoring ....................1-2 Monopolar Surgery........................1-2 Bipolar Surgery........................1-2 Controls, Indicators, and Receptacles Front Panel..........................2-1 Rear Panel..........................2-3...
  • Page 5 Replacement Procedures................ 8-1 Repair Policy & Procedures Obtaining a Return Authorization Number..............9-1 Returning the Monitor for Service ................... 9-1 Limited Warranty........................9-3 Service Parts..................10-1 Service Center Encision Inc. 6797 Winchester Circle Boulder, Colorado 80301-3513 USA (303) 444-2600 www.encision.com 03614-001...

  • Page 6: Foreword

    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.

  • Page 7: Conventions Used In This Manual

    Foreword Conventions Used in this Manual 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.

  • Page 8: Warnings And Cautions

    Foreword Warnings and Cautions Please refer to the manual of your electrosurgical generator for applications information including warnings and precautions regarding its use before proceeding further. Explosion, Fire and Shock Hazards WARNING Explosion Hazard. Do not use electrosurgery in the presence of flammable anesthetics.
  • Page 9 Foreword 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 power setting before proceeding with surgery.
  • Page 10 Foreword 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: ...
  • Page 11 Foreword 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.

  • Page 12: Symbol Definitions

    Foreword 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.
  • Page 13 Foreword This page intentionally left blank. viii 03614-001...

  • Page 14: Accessories-Instructions For Use/Care

    This section is intended to provide the user with an area to add the Instructions for Use/Care. These instructions are provided with the accessories, are for reference only, and are subject to change without notice. The AEM Monitor is to be used with Encision accessories, including: End Point Monitor Remote AEM Cord...
  • Page 15 Accessories, Instructions for Use/Care This page intentionally left blank. 03614-001...

  • Page 16: Introduction

    The AEM system is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling. The Encision AEM system is not intended to test for insulation damage on laparoscopic instruments. Do not attempt to use this system as an instrument inspection tool.

  • Page 17: Active Electrode Monitoring

    Foreword Active Electrode Monitoring Active electrode monitoring technology can eliminate the risk of stray electrical energy caused by insulation failure and capacitive coupling and thus helps to prevent unintended internal burn injury to the patient. AEM instruments direct electrosurgical energy where the surgeon desires, while continuously monitoring the current flow to prevent stray electrosurgical energy from insulation failure or capacitive coupling.

  • Page 18: Controls, Indicators, And Receptacles

    Controls, Indicators, and Receptacles The AEM Monitor front and rear panel features are illustrated and described in this section. Front Panel A POWER Green Indicator 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...
  • Page 19 Controls, Indicators, and Receptacles READY Green Indicator Illuminates if all conditions have been met for AEM Monitoring System operation. AEM CORD Receptacle The AEM cord connects to this receptacle. G Green Inhibit Adapter An adapter that connects to the Electrosurgical Unit (ESU) return electrode receptacle and has a receptacle for the return electrode.

  • Page 20: Rear Panel

    Controls, Indicators, and Receptacles Rear Panel A END POINT MONITOR REMOTE DISPLAY RECEPTACLE Connect the End Point Monitor Remote Display (EMR) to this receptacle. B VOLUME CONTROL Switch Switches between high output, low output or off. C POWER ENTRY MODULE The power cord provided with the AEM Monitor connects to this receptacle.
  • Page 21 Controls, Indicators, and Receptacles This page intentionally left blank. 03614-001...

  • Page 22: Setup And Tests

    Setup and Tests Setup of the AEM Monitoring System (Monopolar) Mounting Mount the AEM Monitor under the electrosurgical generator so the adapter cable reaches the return electrode connector. The AEM Monitor is supplied with feet spaced for compatibility with most equipment carts. Recesses are provided in the cover of the AEM Monitor so most specified electrosurgical generator products may be located securely upon it.
  • Page 23 Setup and Tests Power Cord CAUTION Connect the power cord to a wall outlet having the correct voltage. Otherwise product damage may result. Connect the AEM Monitor power cord to a wall receptacle with 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.

  • Page 24: Optional Functional Test For Operating Room (Before Procedure Begins)

    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 Turn on the electrosurgical generator and enable its contact quality monitoring system.

  • Page 25: Checking The Monitoring System (Monopolar)

    The following is a quick test of the AEM Monitoring System. A failure on any of the following tests should be resolved before use of the system. Please refer to the troubleshooting section to establish the cause of any failure. Encision recommends that this test be performed once per year.
  • Page 26 Setup and Tests 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.
  • Page 27 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.

  • Page 28: Setup Of The End Point Monitoring System (Bipolar)

    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.
  • Page 29 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.

  • Page 30: Checking The End Point Monitoring System (Bipolar)

    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.

  • Page 31: Cleaning

    If you store the AEM Monitor at a temperature that is outside its normal operating range of 50 to 122° F (10 to 50° C), allow one hour for the monitor to reach room temperature before use. Service Center Encision Inc. 6797 Winchester Circle Boulder, Colorado 80301-3513 USA (303) 444-2600 www.encision.com...

  • Page 32: Troubleshooting

    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 Disconnected power Check the power cord connections...
  • Page 33 Troubleshooting Situation Possible Cause Recommended Action continued… Internal cables loose, Check and reseat all internal connections. disconnected, or Turn on and measure the power supply malfunctioning. voltages at J4 on the ESM Main Board. If any voltage is incorrect, replace DC power cable.
  • Page 34 Troubleshooting Situation Possible Cause Recommended Action continued… Malfunctioning ESM Remove the front panel connection to the Main Board. ESM Main Board at J2 and connect a voltmeter shunted with 1K ohms to the +15V supply (+ end of C47) and pin U2- 16.
  • Page 35 Troubleshooting Situation Possible Cause Recommended Action Electrosurgical See possible causes for See recommended action for both generator remains in both “Return Electrode ”Return Electrode indicator is on” and alarm state. indicator is on” and “AEM Cord indicator is on.” “AEM Cord indicator is Both Return Electrode on.”...
  • Page 36 Troubleshooting Situation Possible Cause Recommended Action Electrosurgical Inappropriate internal Turn power switch Off for 30 seconds, generator not in alert state of the AEM then On. Retry operation. If the Ready state during fault. Monitor. indicator is still inappropriately lighted, continue with tests.
  • Page 37 Troubleshooting End Point Monitor (Bipolar) Situation Possible Cause Recommended Action When the power is Disconnected power Check the power cord connections cord, faulty wall (Monitor and wall receptacle). Connect turned ON, all receptacle, or the power cord to a functional wall indicators including the power ON are not malfunctioning power...
  • Page 38 Troubleshooting Situation Possible Cause Recommended Action No bar graph End Point Monitor Verify that nothing is plugged into the indication. Remote plugged into Remote Display connector located on the the End Point Monitor. rear of the End Point monitor. Malfunctioning power Check the power supply’s output voltages supply.
  • Page 39 Troubleshooting Situation Possible Cause Recommended Action No audible indication The Volume Control Set the Volume Control switch to the up (no clicking), correct switch is in the wrong position, High. bar graph indication. position. Malfunctioning speaker, Measure the voltage between ground (- end of C6) and the end of R22 nearest speaker Volume the board edge.
  • Page 40 Troubleshooting Situation Possible Cause Recommended Action “Fuzzy” Indication on Faulty power supply. Check the power supply’s output voltages the bar graph. When at power supply’s J2: indicating near the Pins 2 and 4 are ground; high end of the current Pin 1, + 15.0 ±...
  • Page 41 Troubleshooting Situation Possible Cause Recommended Action Front panel display Malfunctioning EPM Connect the electrosurgical generator does not turn off when Main Board. bipolar output to the Bipolar Generator End Point Monitor receptacle using 2 banana cords. Short Remote is plugged into the Bipolar Accessory receptacle with rear connector.
  • Page 42 Troubleshooting Situation Possible Cause Recommended Action End Point Monitor Defective EPM Main Remove the remote connector. Measure Remote Display does Board. the supply voltage between pins 7 not indicate when (ground) & 4 of J3. Connect the plugged into the AEM electrosurgical generator bipolar output Monitor and the front to the Bipolar Generator receptacles...
  • Page 43 Troubleshooting This page intentionally left blank. 4-12 03614-001...

  • Page 44: Principles Of Operation

    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.
  • Page 45 Principles of Operation 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.
  • Page 46 Principles of Operation Protective Shell Primary Insulation Layer Active Electrode Element Outer Insulation 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.

  • Page 47: Circuit Operation (Monopolar)

    Principles of Operation Circuit Operation (Monopolar) The following Block Diagram (ESM 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. ESM Adapter Relay The adapter places the AEM Monitor relay electrically between the return electrode and the electrosurgical unit (ESU).
  • Page 48 Principles of Operation 03614-001...
  • Page 49 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.
  • Page 50 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.
  • Page 51 Principles of Operation 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.

  • Page 52: Theory Of Operation - End Point Monitoring System

    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.
  • Page 53 Principles of Operation 5-10 03614-001...
  • Page 54 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.
  • Page 55 Principles of Operation This page intentionally left blank. 5-12 03614-001...

  • Page 56: Surgical Use

    Surgical Use Before Surgery It is important to mount the AEM Monitor under the electrosurgical generator so the adapter cable reaches the return electrode connector. The AEM Monitor is supplied with feet spaced for compatibility with most equipment carts. Recesses are provided in the cover of the AEM Monitor so most specified electrosurgical generator products may be located securely upon it.

  • Page 57: Monopolar Surgery

    Surgical Use Monopolar Surgery Active electrode monitoring is intended to control stray monopolar energy caused by insulation failure and capacitive coupling on the shaft of the AEM instrument. CAUTION The Active Electrode Monitoring System technology is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling.

  • Page 58: Checking The Aem Monitoring System

    Surgical Use Checking the AEM Monitoring System The following is a quick test of the AEM Monitoring System. A failure of this test should be resolved before using the system. Please refer to the Troubleshooting Section to establish the cause of any failure. Verify that the setup fault indicators are off and the READY indicator illuminates on the AEM Monitor.

  • Page 59: Bipolar Surgery

    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.

  • Page 60: Checking The End Point Monitoring System

    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.

  • Page 61: General Precautions

    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 the use in laparoscopy. Do not use for other procedures.

  • Page 62: Responding To Monitor Alarms

    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).

  • Page 63: Preparing The Aem Monitor For Reuse

    30 seconds and the generator is inhibited for 10 seconds following a beep from the AEM Monitoring System.  Replace both the instrument and Encision shield or integrated AEM instrument, whichever is appropriate.  If the INSULATION indicator continues to illuminate, use a backup AEM Monitor to complete the surgical procedure.

  • Page 64: Technical Specifications

    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 two tones sound.

  • Page 65: Functional Characteristics

    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.

  • Page 66: Connectors And Cables

    Technical Specifications RETURN ELECTRODE, yellow light Indicates that the return electrode is not properly connected, the adapter is malfunctioning, or that a dual pad electrode is not being used. Operative Fault Indicators INSULATION, red light Indicates that there is excessive current or arcing between the active electrode and the shield.
  • Page 67 Technical Specifications AEM CORD receptacle on front panel A unique, two-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.

  • Page 68: Electrical Characteristics

    Technical Specifications Electrical Characteristics Input Power Requirements 220-240 Volt 230 V~ nominal 220 - 240 Volts ~, 47 - 63 Hz Normal current drain 0.2 A Maximum current 0.5 A Chassis Source Leakage Current 100 A maximum Patient Leakage Current Source or sink leakage current is 10 A maximum Dimensions and Weight External Dimensions...

  • Page 69: Standards And Iec Classifications

    Manufacturer’s declaration – electromagnetic emissions (EN 60601-1-2:2002 Table 201) The Encision Model EM2 series AEM Monitor and accessories are intended for use in the electromagnetic environment specified below. The customer or user of the equipment should assure that it is used in such an environment.
  • Page 70 Manufacturer’s declaration – electromagnetic immunity (EN 60601-1-2:2002 Table 202) The Encision Model EM2 series AEM Monitor and accessories are intended for use in the electromagnetic environment specified below. The customer or user of the equipment should assure that it is used in such an environment.
  • Page 71 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 customer or user of the equipment should as sure that it is used in such an environment.
  • Page 72 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.

  • Page 73: Compatible Products

    Force EZ Not 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. If ES9015 Universal Adapter not being used.

  • Page 74: Replacement Procedures

    Replacement Procedures This section gives instructions on replacing a specific part of your AEM Monitor. For your reference, a physical layout and electrical interconnect diagram that illustrates the placement of parts and all cable connections is provided in Section 10. WARNING Electric Shock Hazard.
  • Page 75 (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.
  • Page 76 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.
  • Page 77 Replacement Procedures Reinstall Cover Repeat the tests that failed. Proceed only if all tests pass. Slide cover over the chassis. Line up the holes in the cover with the tapped holes in the chassis. Install the six screws, previously removed, that secure the cover to the chassis.
  • Page 78 Replacement Procedures Inhibit Adapter Replacement 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.
  • Page 79 Replacement Procedures Push here to remove the contact. Push the contact down and toward the wire. Bottom view of connector Do not disconnect white wires. Black White White Green Yellow Verify that the AEM Monitor functions properly per Section 3 of this manual. Perform normal electrical safety tests as required per hospital protocols.

  • Page 80: Repair Policy & Procedures

    Repair Policy & Procedure Obtaining a Return Authorization Number Before you return the AEM Monitor, front panel or power supply to Encision, call the Encision Customer Service Center to obtain a Return Authorization Number or call your Encision Representative for assistance.
  • Page 81 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 Winchester Circle...

  • Page 82: Limited Warranty

    THE PRODUCTS SHALL BE AS STATED HEREIN Exclusions: The express warranty set forth above specifically excludes and does not apply to defects (i) caused through no fault of ENCISION during shipment to or from Buyer, (ii) caused by modifications or alterations made to...
  • Page 83 (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...

  • Page 84: Service Parts

    Service Parts Replacement parts for the AEM Monitor are listed in this section. If a part is not listed, it is not available. For schematics or replacement part information, please contact the Encision Service Center (303-444-2600). A.C. Power Cord, 220-240V Contact Encision D.C.
  • Page 85 Service Parts Volume Control To Remote Endpoint Monitor Speaker Power Entry Module Three Output Power Supply DC Power Cable I/F Cable AEM Monitor (ESM) Main Board End Point Monitor (EPM) Main Board To Electrosurgical To Bipolar To AEM Cord To Inhibit Adapter Generator –...

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