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Encision EM3 AEM, User Manual, Page: 2 / 48

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  Manufactured By:

 

Encision Inc. 
6797 Winchester Circle 
Boulder, Colorado, USA,  80301-3513 
Made in Bulgaria 

Ph: 800-998-0986 
Fax: 303-444-2693 

www.encision.com

 

[email protected] 
 

  Authorized Representative: 

(according to MDD93/42/EEC) 

 

MDSS GmbH 

 

Schiffgraben 41 

 

30175 Hannover, Germany 

 

US Patents

 

# 5,312,401 and 5,688,269.  

International Patents 

Japan Patent # 2,509,081 
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 
© 2018 Encision Inc.  All rights reserved. 

EM3 

Summary of Contents for EM3 AEM

Page 1: ...04642 003 User s Guide EM3 AEM Monitor...

Page 2: ...ben 41 30175 Hannover Germany US Patents 5 312 401 and 5 688 269 International Patents Japan Patent 2 509 081 Canada Patent 2 112 817 European Patent Convention 0596909 Australia Patent 667322 Tradema...

Page 3: ...anel 2 2 Rear Panel 2 4 3 System Setup Setup for Monopolar Applications 3 1 Maximum Power Settings for Electrosurgical Generators 3 4 Instrument Functional Test Monopolar 3 4 Setup for End Point Monit...

Page 4: ...s 7 2 Bipolar Current Indicator 7 2 Connectors and Cables 7 3 Maximum Generator Voltage 7 4 Electrical Characteristics 7 4 Dimensions and Weight 7 4 Environmental Characteristics 7 4 Standards and IEC...

Page 5: ...acitive 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 Contrain...

Page 6: ...tions at all times When using electrosurgery in the same room with any of these substances or gases prevent their accumulation or pooling under surgical drapes or within the area where electrosurgery...

Page 7: ...solated output generators To reduce the potential for alternate site skin burns do one or more of the following Avoid skin to skin contact points such as fingers touching leg when positioning the pati...

Page 8: ...s 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...

Page 9: ...ion provided in the accompanying documents Portable and mobile RF communications equipment can affect medical electrical equipment Symbol Definitions EM3 Symbol Glossary Symbol Meaning ISO 7000 Ref No...

Page 10: ...andle 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: ...ive 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 Int...

Page 12: ...stem 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...

Page 13: ...ptacle Connect the Monopolar Adapter to this receptacle and to the electrosurgical generator ESU See Section 3 for system setup Cable Channel Route the Monopolar Adapter cable through this channel to...

Page 14: ...ode is properly connected and ready for use Illuminates amber if the return electrode is of the wrong type or is not connected Return Electrode Receptacle Connect the return electrode to this receptac...

Page 15: ...are properly connected and ready for use Illuminates blinking green when a foot control instrument is activated Illuminates solid amber if a foot control instrument insulation fault or cord connectio...

Page 16: ...nductor to this pin as required by country electrical standards optional Fuse Drawer The external fuses are located in this drawer See Section 8 for instructions on replacing blown fuses Power Entry M...

Page 17: ...he operating suite The Quick Setup Guide can be stored in the Tray located at the front of the Monitor Setup for Monopolar Applications 1 Connect the power cord supplied with the AEM Monitor to the po...

Page 18: ...ct the monitor power cord to a wall receptacle with the proper voltage CAUTION Connect the power cord to a wall outlet having the correct voltage Otherwise product damage may result Self Check Power O...

Page 19: ...using a foot controlled instrument connect the AEM Cord with the AEM instrument to the Foot Control Instrument receptacle When using a hand controlled instrument connect the instrument cord to the Han...

Page 20: ...80 60 Fulgurate Coag 80 70 Spray Coag 80 65 Spray Coag 80 70 All Remaining Modes 80 80 Instrument Functional Test Monopolar This optional test performed before surgery begins verifies proper function...

Page 21: ...U Adapter 4 Connect the AEM Monitor power cord to a wall receptacle with the proper voltage CAUTION Connect the power cord to a wall outlet having the correct voltage Otherwise product damage may resu...

Page 22: ...of the bipolar instrument cord to the instrument and the other end to the Bipolar Instrument receptacle on the AEM Monitor 8 Adjust the volume of the clicks that indicate bipolar current flow using t...

Page 23: ...rease the power setting to obtain a mid scale illumination of the bar graph This test ensures that all three components cord bipolar instrument and Bipolar Current Indicator are functional 1 Set the g...

Page 24: ...ivated when the power is switched on While power to the AEM Monitor is on POST may be initiated by pressing the Reset button During POST all of the visual indicators illuminate At the end of a success...

Page 25: ...ary to add approximately 10 ohms of resistance between the dual foils of the return electrode to satisfy the ESU s contact quality monitor Connect a foot control instrument cord with no instrument con...

Page 26: ...nd plug Monopolar Adapter receptacle and pins Instrument receptacles sockets and pins on front panel Front panel keypad buttons and LED indicators Power switch Power entry module Cleaning the AEM Moni...

Page 27: ...and then turn on If the problem persists return the AEM Monitor for service One or both of the Cord Connection Fault indicators illuminate amber even though a cord and instrument are connected Poor co...

Page 28: ...cal generator in alert state Reset the contact quality monitor on the electrosurgical generator Dual foil open or short circuited Install dual foil so that correct resistance is seen by the electrosur...

Page 29: ...tor Use a test lead with alligator clips to short together the two contacts of the exposed cord end Insert an electrosurgical pencil electrode tip into the cord end until it makes contact with the act...

Page 30: ...tacle Open the fuse drawer Check the fuses and replace if necessary with approved fuses Reinstall the fuse drawer Malfunctioning power entry module or connections Inspect the pins of the power entry m...

Page 31: ...he 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...

Page 32: ...ocar sheath to the patient s tissues This amount of power is enough to quickly cause a serious burn AEM instruments in conjunction with an AEM Monitor properly connected to the electrosurgical generat...

Page 33: ...t 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 The...

Page 34: ...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 th...

Page 35: ...nt 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...

Page 36: ...on the electrosurgical generator are sufficient If a foot control instrument is being used ensure that the foot pedal is properly connected to the ESU Reset the ESU s pad monitoring system applies to...

Page 37: ...During this alarm condition the instrument indicator for the active instrument also illuminates amber For a foot control instrument Disconnect the AEM Cord from the AEM Monitor Reconnect the AEM Cord...

Page 38: ...onopolar Setup Fault Detection If the return electrode is disconnected or the wrong type of return electrode is connected an amber indicator illuminates to identify the deficiency If an AEM cord or AE...

Page 39: ...hield Once triggered the text illuminates for 30 seconds and there are 3 bursts of 3 beeps The audio volume is fixed and cannot be adjusted or turned off Status Indicators POST Reset Indicator green L...

Page 40: ...e to the AEM Monitor Monopolar Adapter Receptacle A six pin receptacle on the top cover of the AEM monitor Connects the Monopolar Adapter to the AEM Monitor The design of the receptacle ensures the ad...

Page 41: ...10 kPa Standards and IEC Classifications Class I Equipment per IEC 60601 1 EN 60601 1 Protection against electrical shock is provided by connection of accessible conductive parts to the protective gro...

Page 42: ...iance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are cover...

Page 43: ...the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency...

Page 44: ...to 80 MHz _ D 1 2 P 80 MHz to 800 MHz _ D 1 2 P 800 MHz to 2 5 GHz _ D 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output...

Page 45: ...itor Use of an untested ESU may result in an inoperative active electrode monitoring system Contact Encision Customer Service for more information CAUTION All electrosurgical generators must have a co...

Page 46: ...lacement procedure is only for external fuses 1 Release the fuse drawer by inserting a small flat head screwdriver into the slot at the bottom of the fuse drawer and pulling gently on the drawer Slide...

Page 47: ...ounds solvents or other materials that could scratch the panels or damage the unit Do not steam sterilize the AEM Monitor Shipping the Monitor The monitor should be completely dry before you pack it f...

Page 48: ...l 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 expe...

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