Mortara ELI 230 User manual

REF 9515-175-50-ENG Rev G1
ELI 230
12-LEAD RESTING ELECTROCARDIOGRAPH
USER MANUAL
Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.

NOTICES
ii
Manufacturer’s Responsibility
Mortara Instrument, Inc. is responsible for the effects on safety and performance only if:
• Assembly operations, extensions, readjustments, modifications, or repairs are carried out only by persons
authorized by Mortara Instrument, Inc.
• The device is used in accordance with the instructions for use.
Responsibility of the Customer
The user of this device is responsible for ensuring the implementation of a satisfactory maintenance schedule.
Failure to do so may cause undue failure and possible health hazards.
Equipment Identification
Mortara Instrument, Inc. equipment is identified by a serial and reference number on the back of the device. Care
should be taken so that these numbers are not defaced.
Copyright and Trademark Notices
This document contains information that is protected by copyright. All rights are reserved. No part of this
document may be photocopied, reproduced, or translated to another language without prior written consent of
Mortara Instrument, Inc.
Other Important Information
The information in this document is subject to change without notice.
Mortara Instrument, Inc. makes no warranty of any kind with regard to this material including, but not limited to,
implied warranties of merchantability and fitness for a particular purpose. Mortara Instrument, Inc. assumes no
responsibility for any errors or omissions that may appear in this document. Mortara Instrument, Inc. makes no
commitment to update or to keep current the information contained in this document.

WARRANTY INFORMATION
iii
Your Mortara Warranty
MORTARA INSTRUMENT, INC. (hereafter referred to as “Mortara”) warrants that components within Mortara
products (hereafter referred to as “Product/s”) will be free from defects in workmanship and materials for the
number of years specified on documentation accompanying the product, or previously agreed to by the purchaser
and Mortara, or if not otherwise noted, for a period of twenty-four (24) months from the date of shipment.
Consumable, disposable or single use products such as, but not limited to, PAPER or ELECTRODES are warranted
to be free from defects in workmanship and materials for a period of 90 days from the date of shipment or the date
of first use, whichever is sooner.
Reusable product such as, but not limited to, BATTERIES, BLOOD PRESSURE CUFFS, BLOOD PRESSURE
HOSES, TRANSDUCER CABLES, Y-CABLES, PATIENT CABLES, LEAD WIRES, MAGNETIC STORAGE
MEDIUMS, CARRY CASES or MOUNTS, are warranted to be free from defects in workmanship and materials for
a period of 90 days. This warranty does not apply to damage to the Product/s caused by any or all of the following
circumstances or conditions:
a) Freight damage;
b) Parts and/or accessories of the Product/s not obtained from or approved by Mortara;
c) Misapplication, misuse, abuse, and/or failure to follow the Product/s instruction sheets and/or information
guides;
d) Accident; a disaster affecting the Product/s;
e) Alterations and/or modifications to the Product/s not authorized by Mortara;
f) Other events outside of Mortara’s reasonable control or not arising under normal operating conditions.
THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT
CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCT/S FOUND UPON EXAMINATION BY
MORTARA TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara
of any alleged defects promptly after discovery thereof within the warranty period. Mortara’s obligations under the
foregoing warranty will further be conditioned upon the assumption by the purchaser of the Product/s (i) of all
carrier charges with respect to any Product/s returned to Mortara’s principal place or any other place as specifically
designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It
is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A
purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable
for loss, harm, or damage due directly or indirectly to an occurrence or consequence therefrom relating to the
Product/s. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth
herein) for loss, harm, or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm, or
damage, or the original purchase price of the Product/s when sold.

WARRANTY INFORMATION
iv
EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A
PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE
PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE
THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS
NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT,
INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL,
SPECIAL, OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE, OR EXPENSE OF
ANY KIND, INCLUDING LOSS OF PROFITS, WHETHER UNDER TORT, NEGLIGENCE OR STRICT
LIABILITY THEORIES OF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY
OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED
WARRANTY OF MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE.

USER SAFETY INFORMATION
v
Warning: Means there is the possibility of personal injury to you or others.
Caution: Means there is the possibility of damage to the device.
Note: Provides information to further assist in the use of the device.
Warning(s)
•This manual gives important information about the use and safety of this device. Deviating from operating
procedures, misuse or misapplication of the device, or ignoring specifications and recommendations could
result in increased risk of harm to users, patients and bystanders, or damage to the device.
•Device captures and presents data reflecting a patient’s physiological condition that when reviewed by a trained
physician or clinician can be useful in determining a diagnosis; however, the data should not be used as a sole
means for determining a patient’s diagnosis.
•Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient
care, and adequately trained in the use of this device. Before attempting to use this device for clinical
applications, the operator must read and understand the contents of the user manual and other accompanying
documents. Inadequate knowledge or training could result in increased risk of harm to users, patients and
bystanders, or damage to the device. Contact Mortara service for additional training options.
•To ensure that electrical safety is maintained during operation from AC (~) power, the device must be plugged
into a hospital-grade outlet.
•Only use parts and accessories supplied with the device and/or are available through Mortara Instrument, Inc.
•Patient cables intended for use with the device include series resistance (9 Kohm minimum) in each lead for
defibrillation protection. Patient cables should be checked for cracks or breakage prior to use.
•Conductive parts of the patient cable, electrodes, and associated connections of type CF applied parts, including
the neutral conductor of the patient cable and electrode, should not come into contact with other conductive
parts including earth ground.
•ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or inflammation.
•To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with
device or patient cables. Additionally, proper placement of defibrillator paddles in relation to the electrodes is
required to minimize harm to the patient.
•Proper clinical procedure must be employed to prep the electrode sites and to monitor the patient for excessive
skin irritation, inflammation, or other adverse reactions. Electrodes are intended for short-term use and should
be removed from the patient promptly following testing.

USER SAFETY INFORMATION
vi
•To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes) must
not be reused. To maintain safety and effectiveness, electrodes must not be used beyond their expiration date.
•A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture.
•Where the integrity of external protective earth conductor arrangement is in doubt, the device shall be operated
from its internal electrical power source.
•Medical devices have been designed to have a higher degree of protection against electric shock than, for
instance, information technology equipment because patients often are connected to multiple devices and also
may be more prone to the adverse effect of electric currents than healthy persons. All equipment that is
connected to the patient, can be touched by the patient, or can be touched by another person while that person
touches the patient at the same time, should have the same level of protection against electric shock as medical
equipment. The ELI 230 is a medical device that has been designed to be connected to other devices for the
purpose of receiving and transmitting data. Certain measures must be taken to prevent the risk of excessive
electric current flow through the operator or patient when connected:
•All electrical equipment that is not medical electrical equipment must be placed outside of the “patient
environment,” defined by applicable safety standards to be at least 1.5 meters (5 feet) from the patient.
Alternatively, non-medical equipment may be provided with additional protection such as an additional
protective earth connection.
•All medical electrical equipment that has a physical connection to the ELI 230 or the patient, or is in the
patient environment must comply with applicable safety standards for medical electrical devices.
•All electrical equipment that is not medical electrical equipment and has a physical connection to the
ELI 230 must comply with applicable safety standards, such as IEC 60950 for information technology
equipment. This includes information network equipment connected through the LAN connector.
•Conductive (metal) parts that can be touched by the operator in normal use and that are connected to non-
medical equipment should not be brought into the patient environment. Examples are connectors for
shielded Ethernet or USB cables.
•If multiple devices are connected to each other or to the patient, device chassis and patient leakage
currents may be increased, and should be measured for compliance with applicable standards for medical
electrical systems.
•Avoid the use of portable multiple socket outlets. If used and not compliant with medical electrical
device standards, an additional protective earth connection is required.
•To prevent electric shock due to unequal ground potentials that may exist between points of a distributed
network system or fault conditions in external network connected equipment, network cable shielding
(where used) must be connected to protective earth ground appropriate to the area where the device is used.
•The device has not been designed for use with high-frequency (HF) surgical equipment and does not provide a
protective means against hazards to the patient.
•When the 40 Hz filter is used, the frequency response requirement for diagnostic ECG equipment cannot be
met. The 40 Hz filter significantly reduces high-frequency components of the ECG and pacemaker spike
amplitudes, and is recommended only if high-frequency noise cannot be reduced by proper procedures.

USER SAFETY INFORMATION
vii
•The quality of the signal produced by the device may be adversely affected by the use of other medical
equipment, including but not limited to defibrillators and ultrasound machines.
•For proper operation and the safety of users or patients and bystanders, equipment and accessories must be
connected only as described in this manual.
Caution(s)
•To prevent possible damage to the keyboard, do not use sharp or hard objects to depress keys, only use
fingertips.
•Do not attempt to clean the device or patient cables by submersing into a liquid, autoclaving, or steam cleaning
as this may damage equipment or reduce its usable life. Wipe the exterior surfaces with a warm water and mild
detergent solution and then dry with a clean cloth. Use of unspecified cleaning/disinfecting agents, failure to
follow recommended procedures, or contact with unspecified materials could result in increased risk of harm to
users, patients and bystanders, or damage to the device.
•No user-serviceable parts inside. Screw removal by qualified service personnel only. Damaged or suspected
inoperative equipment must be immediately removed from use and must be checked/repaired by qualified
service personnel prior to continued use.
•The rechargeable internal battery is a sealed lead-acid type and it is totally maintenance free. If the battery
appears to become defective, refer to Mortara Instrument Service Department.
•Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. Patient cables
should be stored after forming them into a loose loop.
•No calibration or special equipments are needed for the proper operation or maintenance of the device.
•The WAM will only work with receiving devices that are equipped with the appropriate option.
•No user-serviceable parts are inside the WAM. Damaged or suspected inoperative equipment must be
immediately removed from use and must be checked/repaired by qualified service personnel prior to continued
use.
•This WAM is not recommended for use in the presence of imaging equipment such as Magnetic Resonance
Imaging (MRI) and Computed Tomography (CT) devices, etc.
•The following equipment may cause interference with the WAM RF channel: microwave ovens, diathermy
units with LANs (spread spectrum), amateur radios, and government radar.
•AA batteries are known to leak their contents when stored in unused equipment. Remove battery from WAM
when not used for an extended period of time.
•Be careful to insert the connector block into the appropriate input connector by matching the lead wire labels to
the WAM or AM12 label.
•When necessary, dispose of the device, its components and accessories (e.g., batteries, cables, electrodes),
and/or packing materials in accordance with local regulations.

USER SAFETY INFORMATION
viii
FCC Compliance Statement for the WAM
In the United States use of this device is regulated by the Federal Communications Commission (FCC). The WAM
with its antenna complies with FCC’s RF exposure limits for general population/uncontrolled exposure.
FCC Warning (Part 15.21): Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the device.
WAM FCC ID: HJR-WAM2500
UTK FCC ID: HJR-UTK2500
These devices comply with Part 15 of the FCC rules. Operation is subject to the following conditions:
1. This device may not cause harmful interference, and
2. This device must accept any interference received, including interference that may cause undesired operation.
Industry Canada Compliance Statement
These devices comply with RSS-210 of the Industry Canada rules. Operation is subject to the following two
conditions:
1. This device may not cause interference, and
2. This device must accept any interference, including interference that may cause undesired operation of the
device.
WAM IC: 3758B-WAM2500
UTK IC: 3758B-UTK2500
The term “IC:” before the certification/registration number only signifies that the Industry Canada technical
specifications were met.
Note(s)
•Patient movements may generate excessive noise that may affect the quality of the ECG traces and the proper
analysis performed by the device.
•Proper patient preparation is important to proper application of ECG electrodes and operation of the device.
•There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used
simultaneously with the device; however, disturbance to the signal may occur.
•The WAM LEDs will automatically start flashing if the batteries have been discharged below 1.0 volts.
•During normal WAM/AM12 operation, the green LED will display continuously.
•If the WAM battery cover is opened during transmission, the device will stop transmitting. The battery must be
reinserted and the cover must be applied to resume operation.
•The WAM will automatically turn off (LEDs off) if the battery has been severely discharged.

USER SAFETY INFORMATION
ix
•The WAM will automatically turn off when the electrocardiograph is powered down.
•The WAM will automatically turn off after being disconnected from the patient. This will happen regardless of
ELI 230 battery/AC power state.
•The display of absent waveform display while using the AM12 acquisition module could be due to an improper
auto-calibration. Reconnect the AM12 or power cycle the electrocardiograph.
•Square waves on the display and rhythm printout could be due to the WAM or the AM12 lead wires not being
connected to the patient.
•A square wave presentation on the display while using the WAM may be due to the WAM being turned off,
having no battery, not being paired correctly, operating out of range, or due to a calibration error. Review the
LED indicator on the WAM to ensure the unit is turned on, has proper battery level, is paired correctly, and is
within recommended proximity of the electrocardiograph, or power cycle the WAM to re-calibrate.
•If an electrode is not connected properly to the patient, or one or more of the patient cable lead wires are
damaged, the display will indicate a lead fault for the lead(s) where the condition is present and if the signal is
being printed, the respective lead(s) will print out as a square wave. Overload or saturation of amplifier inputs
will also result in lead fault indications.
•As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows:
•Class I equipment or internally powered.
•Type CF defibrillation-proof applied parts.
•Ordinary equipment.
•Equipment not suitable for use in the presence of a flammable anesthetic mixture.
•Continuous operation.
NOTE: From a safety perspective, per IEC 60601-1 and derivative standards/norms, this device is
declared to be “Class I” and uses a three-prong inlet to ensure an earth connection is made along with
mains. The ground terminal on the mains inlet is the only protective earth point in the device. Exposed
metal accessible during normal operation is double insulated from mains. Internal connections to earth
ground are functional earth.
•This device is intended to be used in a hospital or doctor’s office setting, and should be used and stored
according to the environmental conditions specified below:
Operating temperature: +10° to +40° C (+50° to +104° F)
Operating humidity: 10% to 95% RH, non-condensing
Storage temperature: -40° to +70° C (-40° to +158° F)
Storage humidity: 10% to 95% RH, non-condensing
Atmospheric pressure: 500 hPa to 1060 hPa
•WAM™ (wireless acquisition module) must be paired to electrocardiograph before operation.
•Device must be configured at the factory for use with the WAM.

USER SAFETY INFORMATION
x
•After operating the device using battery power, always reconnect the power cord. This ensures that the
batteries will be automatically recharged for the next time you use the device. A light next to the on/off switch
will illuminate indicating that the device is charging. This light will turn off when the battery is fully charged.
•The power supply cord and appliance inlet serve as the means to disconnect the unit from the mains power
supply. To remove mains power from the unit, disconnect the power supply cord from the appliance inlet.
•The device is UL classified:
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY IN ACCORDANCE WITH UL2601-1, IEC60601-1,
CAN/CSA CC22.2 No. 601.1, AND IEC60601-2-25

EQUIPMENT SYMBOLS AND MARKINGS
xi
Device Symbol Delineation
Attention, consult accompanying documents
Alternating current
Battery Charging Indicator
ECG
ECG Patient Cable Input
Protective earth
Defibrillator-proof type CF applied part
ON/OFF (power)
RHY
Continuous Rhythm
ECG
12-Lead ECG
Do not dispose as unsorted municipal waste. Per European Union
Directive 2002/96, requires separate handling for waste disposal according
to national requirements
Antenna
Indicates compliance to applicable European Union directives

EQUIPMENT SYMBOLS AND MARKINGS
xii
Package Symbol Delineation
This side up
Fragile
Keep Dry
Keep Away from Heat
Acceptable Temperature Range
Contains Non-spillable Battery

GENERAL CARE
xiii
Precautions
•Turn off the device before inspecting or cleaning.
•Do not immerse the device in water.
•Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents which may damage
equipment surfaces.
Inspection
Inspect your equipment daily prior to operation. If you notice anything that requires repair, contact an authorized
service person to make the repairs.
•Verify that all cords and connectors are securely seated.
•Check the case and chassis for any visible damage.
•Inspect cords and connectors for any visible damage.
•Inspect keys and controls for proper function and appearance.
Cleaning Exterior Surfaces and Patient Cable
1. Remove cables and lead wires from device before cleaning.
2. For general cleaning of cables and lead wires, use a soft, lint-free cloth lightly moistened with a mild soap
and water solution. Wipe and air dry.
3. For disinfecting the cables and lead wires, wipe exterior with a soft, lint-free cloth using a solution of
Sodium Hypochlorite (10% household bleach and water solution) minimum 1:500 dilution (minimum 100
ppm free chlorine) and maximum 1:10 dilution as recommended by the APIC Guidelines for Selection and
Use of Disinfectants.
4. Use caution with excess liquid as contact with metal parts may cause corrosion.
5. Do not immerse cable ends or lead wires; immersion can cause metal corrosion.
6. Do not use excessive drying techniques such as forced heat.
WARNING: Prevent liquid from penetrating the device and do not attempt to clean/disinfect the
device or lead wires by submerging into a liquid, autoclaving, or steam cleaning. Never expose lead wires
to strong ultra-violet radiation. Do not sterilize the device or ECG lead wires with Ethylene Oxide (EtO)
gas..
Cleaning the Device
Disconnect the power source. Clean the exterior surface of the device with a damp, soft, lint-free cloth using a
solution of mild detergent diluted in water. After washing, thoroughly dry off the device with a clean, soft cloth or
paper towel.
Cautions
Improper cleaning products and processes can damage the device, produce brittle lead wires and cables, corrode the
metal, and void the warranty. Use care and proper procedure whenever cleaning or maintaining the device.

GENERAL CARE
xiv

ELECTROMAGNETIC COMPATIBILITY (EMC)
xv
Electromagnetic compatibility with surrounding devices should be assessed when using the device.
An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic
compatibility (EMC) has been performed on the device according to the international standard for EMC for medical
devices (IEC 60601-1-2). This IEC standard has been adopted in Europe as the European Norm (EN 60601-1-2).
The device should not be used adjacent to, or stacked on top of other equipment. If the device must be used
adjacent to or stacked on top of other equipment, verify that the device operates in an acceptable manner in the
configuration in which it will be used.
Fixed, portable, and mobile radio frequency communications equipment can affect the performance of medical
equipment. See appropriate EMC table for recommended separation distances between the radio equipment and the
device.
The use of accessories, transducers, and cables other than those specified by Mortara Instrument may result in
increased emissions or decreased immunity of the equipment.

ELECTROMAGNETIC COMPATIBILITY (EMC)
xvi
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or
the user of the equipment should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment: Guidance
RF Emissions CISPR 11 Group 2 The equipment must emit electromagnetic energy in order to
perform its intended function. Nearby electronic equipment may
be affected.
RF Emissions CISPR 11 Class A The equipment is suitable for use in all establishments other
than domestic and those directly connected to the public low-
voltage power supply network that supplies buildings used for
domestic purposes.
Harmonic Emissions
IEC 61000-3-2 Complies
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Complies
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or
the user of the equipment should ensure that it is used in such an environment.
Emissions Test Compliance Compliance Level Electromagnetic Environment: Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
+/- 6 kV contact
+/- 8 kV air +/- 6 kV contact +/- 8 kV air Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
+/- 2 kV for
power supply lines
+/- 1 kV for
input/output lines
+/- 2 kV for
power supply lines
+/- 1 kV for
input/output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5 +/- 1 kV differential mode
+/- 2 kV common
mode
+/- 1 kV differential
mode
+/- 2 kV common
mode
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips,
short
interruptions, and
voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
Mains power quality should be that of a typical
commercial or hospital environment.
Power frequency
(50/60 Hz)
magnetic field
3 A/m 3 A/m Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE: UT is the AC Mains voltage prior to application of the test level.

ELECTROMAGNETIC COMPATIBILITY (EMC)
xvii
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or
the user of the equipment should ensure that it is used in such an environment.
Emissions Test IEC 60601 Test
Level Compliance Level Electromagnetic Environment: Guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
150 kHz to
80 MHz
Portable and mobile RF communications equipment
should be used no closer to any part of the equipment,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
P
Vrms
d⎥
⎦
⎤
⎢
⎣
⎡
=35.3
P
mV
d⎥
⎦
⎤
⎢
⎣
⎡
=/3 5.3 80 MHz to 800 MHz
P
mV
d⎥
⎦
⎤
⎢
⎣
⎡
=/3 7800 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 surveya, should
be less than the compliance level in each frequency
rangeb.
Interference may occur in the vicinity of equipment
marked with the following symbol:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
80 MHz to
2.5 GHz
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radios, 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 equipment is used exceeds the applicable RF compliance level above, the
equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the equipment.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.

ELECTROMAGNETIC COMPATIBILITY (EMC)
xviii
Recommended Separation Distances Between Portable and Mobile RF Communications
Equipment and the Equipment
The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the equipment can help to prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
equipment as recommended in the table below, according to the maximum output power of the communications
equipment.
Rated Maximum Output Power
of Transmitter W Separation Distance According to Frequency of Transmitter (m)
150 KHz to 800 MHz 800 MHz to 2.5 GHz
Pd 2.1=Pd 3.2=
0.01 0.1 m 0.2 m
0.1 0.4 m 0.7 m
1 1.2 m 2.3 m
10 4.0 m 7.0 m
100 12.0 m 23.0 m
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where Pis the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 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 the
absorption and reflection from structures, objects, and people.

TABLE OF CONTENTS
xix
INTRODUCTION SECTION 1
Manual Purpose.............................................................................................................................................................1
Audience........................................................................................................................................................................1
Indications for Use ........................................................................................................................................................1
System Description........................................................................................................................................................2
Figure 1-1, ELI 230 System Illustration........................................................................................................................3
Figure 1-2, ELI 230 Left Side .......................................................................................................................................4
Figure 1-3, ELI 230 Rear...............................................................................................................................................4
Figure 1-4, ELI 230 Base ..............................................................................................................................................5
Figure 1-5, ELI 230 Display Overview.........................................................................................................................6
Function Keys..................................................................................................................................................6
Specifications ................................................................................................................................................................8
Accessories....................................................................................................................................................................9
Replacement Lead Sets and Accessories.......................................................................................................................9
Electrodes....................................................................................................................................................................10
EQUIPMENT PREPARATION SECTION 2
Connecting the Acquisition Module............................................................................................................................11
Loading Paper..............................................................................................................................................................12
Applying Power...........................................................................................................................................................13
Setting Date and Time.................................................................................................................................................14
Using the AM12 Acquisition Module.........................................................................................................................14
Using the WAM (Wireless Acquisition Module)........................................................................................................14
Indications for Use (WAM)..........................................................................................................................14
WAM with Lead Wires ...............................................................................................................................15
Using the Buttons .........................................................................................................................................15
Approved Battery Models ............................................................................................................................15
WAM Specifications ....................................................................................................................................16
Battery Installation........................................................................................................................................17
Applying Power............................................................................................................................................17
Attaching the Lead Wire Connector Block ..................................................................................................17
Labeling the WAM and Electrocardiograph.................................................................................................17
Pairing the WAM with ELI 230 ...................................................................................................................18
Lead Fail.......................................................................................................................................................18
LED Indicators .............................................................................................................................................18
Cleaning the WAM and ECG Lead Wires ..................................................................................................................19
Periodic Maintenance ...................................................................................................................................19
Disposal of Waste Materials.........................................................................................................................19
Serial and Part Number Location ................................................................................................................................19

TABLE OF CONTENTS
xx
RECORD AN ECG SECTION 3
Patient Preparation.......................................................................................................................................................21
Patient Hookup............................................................................................................................................................21
Patient Demographic Entry .........................................................................................................................................23
ECG Acquisition, Printing, Storage ............................................................................................................................23
Acquisition ...................................................................................................................................................23
Printing.........................................................................................................................................................25
Storage..........................................................................................................................................................25
Acquiring an ECG using the WAM ............................................................................................................................26
Acquiring Rhythm Strips.............................................................................................................................................26
Transfer to a USB Memory Stick................................................................................................................................27
Deleting Records.........................................................................................................................................................27
SYSTEM SETTINGS SECTION 4
Accessing Configuration Menus .................................................................................................................................29
Configuration Settings.................................................................................................................................................31
MAINTENANCE AND TROUBLESHOOTING APPENDIX A
Troubleshooting Charts...............................................................................................................................................35
Test Operation.............................................................................................................................................................35
Recommendations to Biomedical Staff .......................................................................................................................36
Battery Maintenance....................................................................................................................................................36
Cleaning the Thermal Printer ......................................................................................................................................36