Encision EM2+E User manual

AEM
®Monitor
Operator/Service Manual
with AEM® Technology
03614-001

Operator/Service Manual
AEM®Monitor
EM2+E (220-240V)

Manufactured by:
Encision Inc.
6797 Winchester Circle
Boulder, Colorado 80301-3513
Ph: 303-444-2600
Fax: [phone]
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 registered trademark of Covidien/Valleylab
ARM™ is a trademark of ConMed/Aspen Labs
Printed in USA
Part Number: 03614-001 2011/01
© 2011 Encision Inc. All rights reserved.

Table of Contents
Page
Foreword
Indications for Use ...................................................................................................................... i
Contraindications........................................................................................................................ i
Conventions Used in This Manual........................................................................................ ii
Warnings and Cautions...........................................................................................................iii
Symbol Definitions ..................................................................................................................vii
A Accessories-Instructions for Use/Care ....................................................A-1
1 Introduction
Unpacking your System.......................................................................................................1-1
Active Electrode Monitoring ..............................................................................................1-2
Monopolar Surgery................................................................................................................1-2
Bipolar Surgery........................................................................................................................1-2
2 Controls, Indicators, and Receptacles
Front Panel................................................................................................................................2-1
Rear Panel..................................................................................................................................2-3
3 Setup and Tests
Setup of the AEM System (Monopolar) ..........................................................................3-1
Optional Functional Test for Operating Room (before procedure begins) ...........3-3
Checking the 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 Inspection..........................................................................................................3-9
Electrical Inspection ..............................................................................................................3-9
Cleaning.................................................................................................................................. 3-10
Storing the AEM Monitor.................................................................................................. 3-10
Service Center....................................................................................................................... 3-10
4 Troubleshooting.....................................................................................4-1
5 Principles of Operation
Theory of Operation – AEM (Monopolar) ......................................................................5-1
Circuit Operation (Monopolar)..........................................................................................5-4
Theory of Operation - End Point Monitoring System................................................5-9
Circuit Operation (Bipolar) ..................................................................................................5-9
03614-001

Table of Contents
03614-001
Page
6 Surgical Use
Before Surgery......................................................................................................................... 6-1
Monopolar Surgery ...............................................................................................................6-2
Checking the AEM Monitoring System .......................................................................... 6-3
Bipolar Surgery........................................................................................................................ 6-4
Checking the End Point Monitoring System................................................................ 6-5
General Precautions.............................................................................................................. 6-6
Responding to Monitor Alarms......................................................................................... 6-7
Preparing the AEM Monitor for Reuse............................................................................ 6-8
7 Technical Specifications
Operating Modes – AEM Monitoring.............................................................................. 7-1
Functional Characteristics................................................................................................... 7-2
Indicators and Alert Functions .......................................................................................... 7-2
Connectors and Cables ........................................................................................................ 7-3
Electrical Characteristics......................................................................................................7-5
Dimensions and Weight ...................................................................................................... 7-5
Environmental Characteristics ..........................................................................................7-5
Standards and IEC Classifications..................................................................................... 7-6
Compatible Products..........................................................................................................7-10
8 Replacement Procedures........................................................................ 8-1
9 Repair Policy & Procedures
Obtaining a Return Authorization Number.................................................................. 9-1
Returning the Monitor for Service ................................................................................... 9-1
Limited Warranty.................................................................................................................... 9-3
10 Service Parts..........................................................................................10-1
Service Center
Encision Inc.
6797 Winchester Circle
Boulder, Colorado 80301-3513 USA
[phone]
www.encision.com

03614-001 i
Foreword
This manual and the equipment it describes are for use only by qualified medical
professionals trained in the particular technique and surgical procedure to be
performed. This manual is intended as a guide for servicing the AEM Monitor,
including its setup and operation. It is not intended to be a general reference about
the use of electrosurgery either in general application or in laparoscopic procedures.
Indications for Use
The Encision AEM Monitoring System is an accessory for use with
electrosurgical generators and electrodes that is designed to safely deliver
electrosurgical energy and to prevent injury caused by insulation failure and
capacitive coupling.
The AEM Monitoring System consists of two 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 known contraindications for use of the AEM Monitor.
CAUTION
Read and review all instructions in this manual, and in instrument and
accessories instructions for use, prior to using the AEM System.
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.

Foreword
ii 03614-001
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.
Controls, indicators, and receptacles on the unit appear in bold and/or italic
capitals like this:
RETURN ELECTRODE, RETURN ELECTRODE, Return Electrode

Foreword
03614-001 iii
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 [N2O] atmospheres).
The sparking and heating associated with electrosurgery can provide an
ignition source. Observe fire precautions at all times. When using
electrosurgery in the same room with any of these substances or gases,
prevent their accumulation or pooling under surgical drapes, or within the
area where electrosurgery 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.

Foreword
iv 03614-001
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. Use the lowest power setting that achieves the desired surgical
effect.
In order to lessen the possibility of creating unintended burns, activate the
electrosurgical generator only when the active electrode is near or
touching the target tissue.
The safe use of monopolar electrosurgery requires proper placement of the
patient return electrode. To avoid electrosurgical burns beneath the
patient return electrode, follow all directions on the product package for
proper return electrode placement and use.
In some circumstances, potential exists for alternate site burns at points of
skin contact (e.g., between the arm and the side of the body). This occurs
when electrosurgical current seeks a 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
following:
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 the type of electrosurgical generator output used and the intended
application.
Laparoscopic surgery may result in gas embolism due to insufflation of gas
into the abdomen.

Foreword
03614-001 v
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
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 outside
the field of vision may result in injury to the patient. Use these instruments
only under conditions that assure adequate visualization.
Localized burns to the patient or physician may come from electrical
currents carried through conductive objects (such as cannulas or scopes).
Electrical current may be generated in conductive objects by direct contact
with the active 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.

Foreword
vi 03614-001
Inspect cords for breaks, cracks, nicks or other damage before every use.
Ensure that end of life indicators are not present. If any of these are
present, do not use. Failure to observe this precaution may result in injury
or electrical shock to the patient or operating personnel.
Damaged external insulation on instruments AND incorrect setup of the
AEM Monitor may result in a risk of unintended patient burn. Do not use
product having damaged insulation.
CAUTION
Read the instructions, warnings, and cautions provided with the AEM
Monitoring System accessories before using. Their specific instructions are
not included in this manual.
When an alert is presented by the AEM Monitor, 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 only if the self-test has been properly completed.
Otherwise, AEM functions may not be operative.

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.
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
Caution
Power
Consult instructions
for use Ready
Type CF equipment
with defibrillator
protection
Insulation operative
fault
Catalog Number
Return Electrode
setup fault
Serial Number AEM Cord setup fault
Manufacturing Date Bipolar Accessory
Manufacturer Bipolar Jumper Cord
Protective Earth
(Ground) Remote Display Jack
Volume Control:
High/ OFF/ Low
03614-001 vii

Foreword
viii 03614-001
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A 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
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 [phone] for current catalog or go to
www.encision.com.
03614-001 A-1

Accessories, Instructions for Use/Care
A-2 03614-001
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1 Introduction
Congratulations on your purchase of the AEM Monitor. This is state of the art
technology that dynamically manages and monitors stray monopolar current.
CAUTION
The AEM system is designed to safely deliver electrosurgical energy and to
prevent injury caused by insulation failure and capacitive coupling. The
Encision AEM system is not 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
Your system is shipped in one carton. We suggest that you store this carton so
that it will be available if the need for service arises.
Carefully unpack the carton. Check to ensure you received the following parts.
(If any of these parts are missing, please contact our service center as soon as
possible.)
AEM Monitor
Power Cord
Bipolar Jumper Cord Retainer Bracket
Setup Card
Operator/Service Manual (CD version or hard copy)
Contact Customer Service at [phone] to arrange for repair or
replacement of any parts damaged from shipping.
03614-001 1-1

Foreword
1-2 03614-001
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.
AEM instruments have a patented, multi-layered design with a built-in shield,
much like the third wire ground in standard electrical cords. The shield in these
instruments is referenced back to a monitor at the electrosurgical generator. In
the event of a harmful level of stray electrical energy, the monitor shuts down
the power at the source, ensuring patient safety. The AEM system protects
against capacitive coupling by providing a neutral return path for capacitively
coupled electrical current. Capacitively coupled energy is continually drained
away from the instrument and away from the patient through the protective
shield built into all AEM instruments.
Monopolar Surgery
In monopolar electrosurgery, the surgical instrument contains only the active
electrode. A separate return electrode to the patient recovers the current that
passes through the patient and returns it safely to the generator.
Monopolar electrosurgery is used for most surgical procedures that require
sparking to tissue, such as those in which tissue must be cut or coagulated over
wide areas.
Bipolar Surgery
In bipolar electrosurgery, the surgical instrument includes both electrodes. A
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.

2 Controls, Indicators, and
Receptacles
The AEM Monitor front and rear panel features are illustrated and described in this
section.
Front Panel
BH A
D GE
I
J
F C
A POWER Green Indicator
Illuminates when power is supplied. The power switch
is located on the side of the unit.
AEM CORD
B AEM CORD Amber Indicator
Illuminates if the AEM Cord is not connected to the
Monitor or if the cord is not plugged into the AEM
instrument.
RETURN ELECTRODE
C RETURN ELECTRODE Amber Indicator
Illuminates if the return electrode is of the wrong type
or is not connected.
INSULATION
D INSULATION Red Indicator
Illuminates in the event of an internal insulation failure
of an AEM Instrument.
03614-001 2-1

Controls, Indicators, and Receptacles
E READY Green Indicator
Illuminates if all conditions have been met for AEM
Monitoring System operation.
F 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.
Inhibit Adapter Extension (ordered separately, as
needed)
Customizes fit with various ESU return electrode
receptacles
H End Point Monitor Display
Indicates the intensity of current flow.
I BIPOLAR GENERATOR Receptacles
The bipolar jumper cord connects to this receptacle
and to the electrosurgical generator.
J BIPOLAR ACCESSORY Receptacles
Connects bipolar accessories to the AEM Monitor.
2-2 03614-001

Controls, Indicators, and Receptacles
Rear Panel
CAB
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. Fuse drawer is above
the connector.
03614-001 2-3