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Encision EM3 AEM User Manual

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User's Guide
EM3 AEM® Monitor
04642-003

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  • Page 1 User’s Guide EM3 AEM® Monitor 04642-003...
  • Page 2 Canada Patent # 2,112,817 European Patent Convention # 0596909 Australia Patent # 667322 Trademark acknowledgments Encision® and AEM® are registered trademarks of Encision Inc. All other referenced trademarks are owned by their respective owners. Printed in USA Part Number: 04642-003 Rev. F 2018/04...

  • Page 3: Table Of Contents

    Troubleshooting – AEM Monitor (Monopolar) ........4-4 Troubleshooting – Bipolar Current Indicator (Bipolar) ......4-6 Principles of Operation Theory of Operation – AEM Monitoring System (Monopolar)....5-1 Theory of Operation - End Point Monitoring System (Bipolar) ....5-3 EM3 AEM Monitor User’s Guide...
  • Page 4 Obtaining a Return Material Authorization Number......8-1 Cleaning the Monitor ................ 8-2 Shipping the Monitor ................ 8-2 Service Center ................. 8-2 Limited Warranty ................... 8-3 Service Center Encision Inc. 6797 Winchester Circle Boulder, Colorado 80301-3513 USA (800) 998-0986 www.encision.com EM3 AEM Monitor User’s Guide...

  • Page 5: Indications For Use

    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 6: Warnings And Cautions

    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. Electric Shock Hazard. Do not open the AEM Monitor cover. EM3 AEM Monitor User’s Guide...

  • Page 7: General Electrosurgical Hazards

    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). EM3 AEM Monitor User’s Guide...

  • Page 8: Active Accessories And Aem Monitor

    Limit power setting to 80 watts or lower as specified in the power settings tables (see Section 3). Higher settings may result in spurious insulation failure alarms and/or insulation breakdown. Refer to instrument instructions for use for other limits. EM3 AEM Monitor User’s Guide...

  • Page 9: Electromagnetic Compatibility (Emc) Hazards

    2002/96/EC EN50419 separately from the municipal Fuse Rating IEC 60417 Ref# 5016 waste stream. Graphical Representations Instrument Cord Connection Hand Control Connector Return Electrode Fault Foot Control Connector Remote Display Jack Bipolar Accessory EM3 AEM Monitor User’s Guide...

  • Page 10: Accessories

    Accessories Use the AEM Monitor with the following Encision accessories. Separate Instructions for Use are provided with the accessories. EM3 Monopolar Adapter AEM Cord/Cable EM3 Bipolar Adapter Bipolar Instrument Cords AEM Handle Assembly Inserts, Reusable and Disposable Disposable Sheath Fixed Tip Electrodes, Reusable and Disposable Suction Irrigation Electrodes, Reusable and Disposable AC Input Cord, Hospital Grade 120v, 15’...

  • Page 11: Introduction

    CAUTION The Encision AEM System is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling. The 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 12: Active Electrode Monitoring

    In bipolar electrosurgery, the surgical instrument includes both electrodes. A patient return electrode is not 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. EM3 AEM Monitor User’s Guide...

  • Page 13: Controls, Indicators, And Receptacles

    (optional). Tray When extended, the tray provides a convenient place to store the Monopolar Adapter when not connected to the ESU. The tray also has a recess for storing the Quick Setup Guide. EM3 AEM Monitor User’s Guide...

  • Page 14: Front Panel

     Illuminates solid green when a hand control instrument and a return electrode are properly connected and ready for use.  Illuminates blinking green when a hand control instrument is activated. Illuminates solid amber if a hand control instrument insulation fault or cord connection fault is detected. EM3 AEM Monitor User’s Guide...
  • Page 15 See Section 6 for information on correcting fault conditions. Hand Control Instrument Receptacle Connect the hand control instrument cord to this receptacle. Foot Control Instrument Receptacle Connect the foot control instrument cord to this receptacle. EM3 AEM Monitor User’s Guide...

  • Page 16: Rear Panel

    The external fuses are located in this drawer. See Section 8 for instructions on replacing blown fuses. Power Entry Module Connect the power cord provided with the AEM Monitor to this receptacle. Power Switch Power the AEM Monitor on or off with this switch. EM3 AEM Monitor User’s Guide...

  • Page 17: System Setup

    NOTICE If you are familiar with the EM3 AEM Monitoring System, refer to the Quick Setup Guide for system connections and troubleshooting in the operating suite. The Quick Setup Guide can be stored in the Tray located at the front of the Monitor.
  • Page 18 Connect the power cord to a wall outlet having the correct voltage. Otherwise product damage may result. Self-Check (Power On Self Test – POST) Turn on the AEM Monitor. The system completes an automatic self-check (POST). Encision recommends that this self-check be run before beginning each surgical EM3 AEM Monitor User’s Guide...
  • Page 19 Refer to instrument instructions for use for other limits. 14. After successful completion of these steps, the AEM Monitor is ready for use. Encision recommends that a Monopolar System Check be performed before first surgical use.

  • Page 20: Maximum Power Settings For Electrosurgical Generators

    System Setup Maximum Power Settings for Electrosurgical Generators Refer to the following tables for maximum power settings of electrosurgical generators used with the EM3 AEM Monitoring System. Maximum Power Settings for Force FX ESU Maximum Power Settings for System 5000...

  • Page 21: Setup For End Point Monitoring System (Bipolar Applications)

    Self-Check (Power On Self Test – POST) Turn on the AEM Monitor. The system completes an automatic self-check (POST). Encision recommends that this self-check be run before beginning each surgical procedure. If the monitor power is left on between procedures, press the Reset button to initiate the POST function.
  • Page 22 11. After successful completion of these steps, the system is ready for operation. During operation, the Bipolar Current Indicator illuminates, indicating the current flowing between the instrument’s tines. WARNING Do not attempt to connect or disconnect any cable during power activation. EM3 AEM Monitor User’s Guide...
  • Page 23 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 Bipolar Current indicator. The clicking will also change its rate in correspondence with the current. EM3 AEM Monitor User’s Guide...

  • Page 24: System Maintenance And Troubleshooting

    Removal of the monitor cover will void the AEM Monitor warranty. System Maintenance Encision recommends that the AEM Monitor be tested and inspected by qualified service personnel on a minimum yearly basis using the following procedures. If the AEM Monitor fails any of these tests or inspections, refer to the Troubleshooting guides later in this section or contact the Encision Service Center.
  • Page 25  The AEM Monitor Foot Control Instrument indicator illuminates solid amber for 10 seconds.  The AEM Monitor text “Replace Instrument & Cord” illuminates solid amber for 30 seconds.  The AEM Monitor generates an audio alert of 3 bursts of 3 beeps each. EM3 AEM Monitor User’s Guide...

  • Page 26: Mechanical Inspection

    1000 mA. Mechanical Inspection Visually inspect the following items on the AEM Monitoring System and the End Point Monitor. If any of these items appear damaged during the visual inspection, contact the Encision Service Center.  Insulation of wiring and cables ...

  • Page 27: Troubleshooting - Aem Monitor (Monopolar)

    AEM Monitor and reinsert fully. If the Return Electrode indicator illuminates green, unit is OK. If not, wiggle the return electrode connector from side to side. If the indicator does not illuminate green, contact Encision Technical Support. EM3 AEM Monitor User’s Guide...
  • Page 28 If the generator. electrosurgical generator still shows an alarm status, replace the electrosurgical generator. If the above steps have failed, return the AEM Monitor for service. Replace EM3 Monopolar Adapter EM3 Monopolar Adapter is broken EM3 AEM Monitor User’s Guide...
  • Page 29 Activate the coag output and carefully move the free alligator clip toward the pencil electrode tip until an arc is seen. If the AEM Monitor fails to light the text “Replace Instrument & Cord,” return the AEM monitor for service. EM3 AEM Monitor User’s Guide...

  • Page 30: Troubleshooting - Bipolar Current Indicator (Bipolar)

    Reinstall the fuse drawer. Malfunctioning power Inspect the pins of the power entry module. entry module or If faulty, contact Encision Service Center. connections. If the above steps have failed, return the AEM Monitor for service. No surgical effect Faulty cord or Replace the cord and instrument.

  • Page 31: Principles Of Operation

    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. EM3 AEM Monitor User’s Guide...
  • Page 32 (insulation failure and capacitive coupling) in zones 2 & 3. WARNING AEM shielding does not cover zone 1, which the surgeon should keep in view during instrument activation. Protective Shield Primary Insulation Layer Active Electrode Element Outer Insulation EM3 AEM Monitor User’s Guide...

  • Page 33: Theory Of Operation - End Point Monitoring System (Bipolar)

    Thus, it is important not to draw conclusions about the completion of desiccation from the indications of the Bipolar Current Indicator alone. EM3 AEM Monitor User’s Guide...

  • Page 34: Surgical Use

    Connect the power cord to a wall outlet having the correct voltage. Otherwise product damage may result. NOTICE If you are familiar with the EM3 AEM Monitoring System, refer to the Quick Setup Guide for system connections and troubleshooting in the operating suite. The Quick Setup Guide can be stored in the Tray located at the front of the Monitor.

  • Page 35: Bipolar Surgery

    AEM instrument to a second instrument contacting tissue. The second device will not be protected from capacitive coupling and insulation failure. 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. EM3 AEM Monitor User’s Guide...

  • Page 36: Operating Room Troubleshooting

    During this alarm condition, the Foot Control Instrument indicator also illuminates amber.  Check the AEM Cord to ensure that it is securely connected to the Foot Control Instrument receptacle on the AEM Monitor and an AEM foot control instrument. EM3 AEM Monitor User’s Guide...

  • Page 37: Preparing The Aem Monitor For Reuse

    Preparing the AEM Monitor for Reuse 1. Turn off the AEM Monitor. 2. Disconnect all accessories. 3. Follow the cleaning procedure in Section 4. WARNING Electric Shock Hazard. Always unplug the AEM Monitor before cleaning. EM3 AEM Monitor User’s Guide...

  • Page 38: Technical Specifications

    Accuracy: 20% of full scale Range: 0.1 to 1.1 Amperes Maximum current without damage: 3.0 Amperes Click Rate: 2 Hz @ 0.1 Ampere, 40 Hz @ 1.1 Ampere EM3 AEM User’s Guide...

  • Page 39: Indicators And Alert Functions

    RF AMPERES, 8 segment bar-graph display The number of segments illuminated in the bar-graph display is proportional to the amount of bipolar current being delivered. Audible Indication, adjustable volume clicks. The clicks are delivered at a rate proportional to indicated current. EM3 AEM User’s Guide...

  • Page 40: Connectors And Cables

    UL/IEC type receptacle containing two, 1.0 A, 250V, slow blow, 5 × 20 mm fuses (one for each side of the line). Power Cords, attached to power entry module A 15 ft (4.6 m) long, UL and CSA approved 120 V power cord. EM3 AEM User’s Guide...

  • Page 41: Maximum Generator Voltage

    Medical Electrical Equipment needs special precautions regarding electromagnetic compatibility (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. EM3 AEM User’s Guide...
  • Page 42 Manufacturer’s declaration – electromagnetic emissions (EN 60601-1-2) The Encision Model EM3 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 43 Guidance and manufacturer’s declaration – electromagnetic immunity (EN 60601-1-2) The Encision Model EM3 series AEM 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 44 Detection of insulation breakdown if threshold is reached  Proper setup sequence, including detection of dual-foil return electrode  The AEM Monitor provides visual and audible indication of bipolar current (not likely to be affected by the adapter) EM3 AEM User’s Guide...

  • Page 45: Compatible Products

    BP9004 WARNING Electrosurgical generators included in the above list have been tested for use with the EM3 AEM Monitor. Use of an untested ESU may result in an inoperative active electrode monitoring system. Contact Encision Customer Service for more information.

  • Page 46: Replacement Parts And Service

    4. Slide the fuse drawer into its slot until it snaps into place. Returning the AEM Monitor Before returning the AEM Monitor to Encision, call the Encision Customer Service Center to obtain a Return Material Authorization number (RMA) or call your Encision Representative for assistance.

  • Page 47: Shipping The Monitor

    Ship the monitor prepaid to the Encision Service Center. Service Center Encision Inc. 6797 Winchester Circle Boulder, Colorado, 80301-3513 USA Contact Customer Service at 1(800) 998-0986 for local customers call (303) 444-2600 or you can send an email to info@encision.com EM3 AEM Monitor User’s Guide...

  • Page 48: Limited Warranty

    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...

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