Mortara ELI 150c, ELI 250c User manual

REF 9515-177-50-ENG Rev A1

ELI 150c/ELI 250c

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.

Copyright © 2011

by Mortara Instrument, Inc.

7865 N. 86th Street

Milwaukee, Wisconsin 53224

This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document
may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written
consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. E-Scribe, ELI,

®

and VERITAS are trademarks of Mortara Instrument, Inc. Cisco

®

Inc. DICOM

is the registered trademark of the National Electrical Manufacturers Association for its standards

is the registered trademark of Cisco Systems,

publications relating to digital communications of medical information. V1.00.

TECHNICAL SUPPORT AND SERVICE

Headquarters

Mortara Instrument, Inc.

7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: [phone]
Tel: [phone]
Fax: [phone]
Internet: http://www.mortara.com

European Union
Representative

Mortara Rangoni Europe, Srl

(European Headquarters)
Via Cimarosa 103/105
40033 Casalecchio di Reno (BO)
Italy
Tel: [phone]
Fax: [phone]

Service/Technical
Support Group

Mortara Instrument, Inc.

7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: [phone]
Service: 888.MORTARA
(888.667.8272)
Fax: [phone]
E-mail: [e-mail]

24-hour Technical Support
Same-day Shipment of Replacement Parts
Biomedical Training Classes
Extended Warranties/Service Contracts

Sales Support/
Supplies & Accessories

Mortara Instrument, Inc.

7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]

Mortara Instrument Germany

Kaninenberghöhe 50
45136 Essen
Germany
Tel: [phone]
Fax: [phone]

Mortara Instrument Netherlands

Postbus 324
5680 AH Best
Industrieweg 160b
5683 CG Best
Netherlands
Tel: [phone]
Fax: [phone]

Mortara Instrument Australia

PO Box 7568
Baulkham Hills NSW 2153
Unit 28, 9 Hoyle Avenue
Castle Hill NSW 2154
Australia
Tel: [phone]
Fax: [phone]

i

NOTICES

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.

ii

WARRANTY INFORMATION

Your Mortara Warranty

MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara products
(hereinafter referred to as “Product/s”) shall be free from defects in material and workmanship under normal use,
service, and maintenance for the warranty period of such Product/s from Mortara or an authorized distributor or
representative of Mortara. The warranty period is defined as twenty-four (24) months following the date of
shipment from Mortara. Normal use, service, and maintenance means operation and maintenance in accordance
with appropriate instructions and/or information guides. 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.

EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH
AS PAPER, BATTERIES, ELECTRODES, PATIENT CABLES, LEAD WIRES, AND MAGNETIC STORAGE
MEDIUMS.

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.

iii

WARRANTY INFORMATION

iv

USER SAFETY INFORMATION

Warning:

Caution:

Note:

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.

• To maintain designed operator and patient safety, peripheral equipment and accessories used that can come in

direct patient contact must be in compliance with UL 60601-1, IEC 60601-1, and IEC 60601-2-25. Only use
parts and accessories supplied with the device and 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 electrodes, 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.

Means there is the possibility of personal injury to you or others.

Means there is the possibility of damage to the device.

Provides information to further assist in the use of the device.

v

USER SAFETY INFORMATION

• This device was designed to use the electrodes specified in this manual. 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.

• 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.

• To ensure the safety of both the patient and the device, 1.5 meters (5’) of open area should surround the patient.

• 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.

• All signal input and output (I/O) connectors are intended for connection of only those devices complying with

IEC 60601-1, or other IEC standards (e.g., IEC 60950) as appropriate to the device. Connecting additional
devices to the device may increase chassis and/or patient leakage currents. To maintain operator and patient
safety, consideration should be given to the requirements of IEC 60601-1-1, and leakage currents should be
measured to confirm no electric shock hazard exists.

• To improve immunity to potential interfering electromagnetic signals, shielded cabling is recommended when

connecting the device to a network.

• To maintain operator and patient safety, equipment connected to the same network as the device must meet the

requirements of IEC 60950 or IEC 60601-1.

• 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.

• 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. Do not connect a telephone line cable to the LAN connector.

• Some Mortara electrocardiographs can be equipped with a GPRS (cellular modem) or wireless LAN (WLAN)

module for transmitting ECG records. Device labeling and the presence of an antenna port will indicate if your
device is equipped with such a module. If so equipped, the following notices apply:

• The GPRS module operates in allocated frequency bands depending on the model. Identification of

the installed GPRS module can be found on a label on the bottom of the device.

• MultiTech Systems, Inc. Model MTSMC-G-F4 (Quad Band): 850/900/1800/1900 MHz, user

• The WLAN identification can be found on a label on the bottom of the device.

selectable

• Quatech, Inc. Model WLNG-AN-DP101: 2400 MHz

(model subject to change without notice)

vi

USER SAFETY INFORMATION

• Use of the GPRS or WLAN module may interfere with other equipment operating in the vicinity. Check with

local authorities or spectrum management officials in your facility to determine if restrictions apply to the use
of this feature in your area.

• Do not transmit via the GPRS or WLAN module with a missing or damaged antenna. Replace a damaged

antenna immediately.

• Use only the antenna supplied for use with this device. Unauthorized antennas, modifications, or attachments

could damage the GPRS module and may contravene local RF emission regulations or invalidate type approval.

• To ensure compliance with current regulations limiting both maximum RF output power and human exposure
to radio frequency radiation, a separation distance of at least 20 cm must be maintained between the device's
antenna and the head and body of the user and any nearby persons at all times. To help prevent degradation of
RF signal and to avoid excess RF energy absorption, do not touch the antenna during data transmission.

• The GPRS and WLAN modules comply with applicable RF safety standards including standards and

recommendations for the protection of public exposure to RF electromagnetic energy that have been
established by governmental bodies and other qualified organizations, such as the following:

• Federal Communications Commission (FCC)

• Directives of the European Community

• Directorate General V in Matters of Radio Frequency Electromagnetic Energy

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.

● When necessary, dispose of the device, its components and accessories (e.g., batteries, cables, electrodes),

and/or packing materials in accordance with local regulations.

• Use only No. 26 AWG or larger telecommunication line cord.

vii

USER SAFETY INFORMATION

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.

• The algorithm detecting electrode misplacements is based on normal physiology and ECG lead order, and tries

to identify the most likely switch; however, it is advisable to check the other electrode positions in the same
group (limb or chest).

• 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.

• If electrode is not properly connected to the patient, or one or more of the patient cable lead wires is damaged,

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.

• 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.

• 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.

viii

USER SAFETY INFORMATION

• The device is UL classified:

WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY IN ACCORDANCE WITH UL60601-1, IEC60601-1,
CAN/CSA C22.2 No. 601.1, IEC 60601-1-1, CAN/CSA C22.2 No. 60601­1-1-02, IEC60601-2-25 AND CAN/CSA C22.2 No. 601.2.25-94.

• The device is a member of the ELI 1xx or ELI 2xx Series 2 electrocardiograph family.

Wireless Data Transmission

• Some Mortara electrocardiographs can be equipped with an optional wireless data transmission module

(WLAN or GPRS mobile). Both these technologies use radios to transmit data to a Mortara receiving
application. Due to the nature of radio transmissions, it’s possible that, due to the characteristics of the
environment where the device is located, some other RF sources may interfere with the transmission generated
by the device. Mortara Instrument has tested the coexistence of the device with other devices that can interfere
such as devices using WLAN, Bluetooth radio, and/or cell phones. Although the current technology allows a
very successful rate of transmission, it’s possible that in some rare occurrences, the system may not perform at
its best resulting in a “failed transmission.” When this occurs, patient data will not be erased from the device
nor stored in the receiving application, ensuring that partial or corrupted data are not made available to the
receiving station. If the failure mode persists the user should move to a position where the RF signals may
propagate better and allow successful transmissions.

WLAN Option

• Wireless options transmit at 2.4 GHz. Other nearby wireless devices may cause interference. If possible, move

or turn off other devices to minimize potential interference.

• The following table shows the channels allocated in different geographic areas in the world. Please consult

with your IT personnel in order to set the device on the proper channels.

Specification Description

Technology IEEE 802.11 b/g DSSS, WiFi compliant

Frequency

Channels

RF Power +15dBm (typical) approx. 32 mW

2.400 – 2.4835 GHz (U.S./CAN/Japan/Europe)

2.471 – 2.497 GHz (Japan)
U.S.A./CANADA: 11 channels (1-11)
Europe: 13 Channels (1-13)
Japan: 14 Channels (1-14)
France: 4 Channels (10-13)

ix

USER SAFETY INFORMATION

• The following table lists the frequency allocated for each channel used by the WLAN option.

Channel Center Frequency Frequency Spread

1 2412 MHz 2399.5 MHz - 2424.5 MHz

2 2417 MHz 2404.5 MHz - 2429.5 MHz

3 2422 MHz 2409.5 MHz - 2434.5 MHz

4 2427 MHz 2414.5 MHz - 2439.5 MHz

5 2432 MHz 2419.5 MHz - 2444.5 MHz

6 2437 MHz 2424.5 MHz - 2449.5 MHz

7 2442 MHz 2429.5 MHz - 2454.5 MHz

8 2447 MHz 2434.5 MHz - 2459.5 MHz

9 2452 MHz 2439.5 MHz - 2464.5 MHz

10 2457 MHz 2444.5 MHz - 2469.5 MHz

11 2462 MHz 2449.5 MHz - 2474.5 MHz

12 2467 MHz 2454.5 MHz - 2479.5 MHz

13 2472 MHz 2459.5 MHz - 2484.5 MHz

14 2484 MHz 2471.5 MHz – 2496.5 MHz

• In order to achieve the best transmission rate, it is necessary that the facility where the device is operated can

provide good area coverage. Please consult the IT personnel of the facility to verify the proper WLAN
availability in the area where the device will be used.

• RF wave propagation may be blocked or reduced by the environment where the device is used. Most common

areas where this may occur are: shielded rooms, elevators, underground rooms. In all the above situations, it is
recommended to move the device to a proper location and verify with the IT personnel of the facility the areas
where the WLAN signals are available.

x

EQUIPMENT SYMBOLS AND MARKINGS

Symbol Delineation

Attention, consult accompanying documents

Alternating current

Protective earth

Telephone line (modem)

Network (LAN)

Defibrillator-proof type CF applied part

USB port

Input

ON/OFF (power)

Stop (of action)

Shift key (to enter upper case text)

Enter key (accept data/return)

Initiate printing of 12-lead ECG

xi

EQUIPMENT SYMBOLS AND MARKINGS

Initiate printing of continuous rhythm strip

Transmit, receive and time sync operation depending upon configuration
settings

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

xii

GENERAL CARE

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
patient cables by submerging into a liquid, autoclaving, or steam cleaning. Never expose cables 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.

xiii

GENERAL CARE

xiv

ELECTROMAGNETIC COMPATIBILITY (EMC)

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 Table X-4 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.

xv

ELECTROMAGNETIC COMPATIBILITY (EMC)

Table X-1 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 1 The equipment uses RF energy only for its internal function.

Therefore, its RF emissions are very low and not likely to cause
any interference in nearby electronic equipment.

RF Emissions CISPR 11 Class A

Harmonic Emissions
IEC 61000-3-2

Complies

The equipment is suitable for use in all establishments other
than domestic and those directly connected to the public low­voltage power supply network that supplies buildings used for
domestic purposes.

Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3

Complies

Table X-2 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

Electrical fast
transient/burst
IEC 61000-4-4

Surge
IEC 61000-4-5

Voltage dips,
short
interruptions, and
voltage
variations on
power supply
input lines
IEC 61000-4-11

Power frequency
(50/60 Hz)
magnetic field

+/- 6 kV contact
+/- 8 kV air

+/- 2 kV for
power supply lines
+/- 1 kV for
input/output lines

+/- 1 kV differential
mode
+/- 2 kV common
mode

<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles

3 A/m 3 A/m Power frequency magnetic fields should be at

+/- 6 kV contact
+/- 8 kV air

+/- 2 kV for
power supply lines
+/- 1 kV for
input/output lines

+/- 1 kV differential
mode
+/- 2 kV common
mode

<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles

Floors should be wood, concrete, or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.

Mains power quality should be that of a typical
commercial or hospital environment.

Mains power quality should be that of a typical
commercial or hospital environment.

Mains power quality should be that of a typical
commercial or hospital environment.

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.

xvi

ELECTROMAGNETIC COMPATIBILITY (EMC)

Table X-3 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

Radiated RF
IEC 61000-4-3

3 Vrms
150 kHz to
80 MHz

3 V/m
80 MHz to

2.5 GHz

3 Vrms
150 kHz to
80 MHz

3 V/m
80 MHz to

2.5 GHz

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

5.3

⎤

⎡

d

=

⎢

Vrms

3

⎣

P

⎥
⎦

5.3

⎤

⎡

d

=

⎢
⎣

80 MHz to 800 MHz

P

⎥

mV

/3

⎦

7

⎤

⎡

d

=

⎢
⎣

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 survey
be less than the compliance level in each frequency

b

range

.

Interference may occur in the vicinity of equipment
marked with the following symbol:

800 MHz to 2.5 GHz

P

⎥

mV

/3

⎦

a

, should

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.

xvii

ELECTROMAGNETIC COMPATIBILITY (EMC)

Table X-4 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

150 KHz to 800 MHz 800 MHz to 2.5 GHz

Separation Distance According to Frequency of Transmitter (m)

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

Pd 2.1= Pd 3.2=

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 P is 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.

xviii

TABLE OF CONTENTS

INTRODUCTION SECTION 1

Manual Purpose............................................................................................................................................................. 1

Audience........................................................................................................................................................................1

Indications for Use ........................................................................................................................................................1

System Description........................................................................................................................................................ 2

System Illustrations .......................................................................................................................................................3

Display and Keyboard ...................................................................................................................................................5

Automatic Feature Keys..................................................................................................................................5

Display Overview..........................................................................................................................................................6

ELI 150c Specifications ................................................................................................................................................8

ELI 250c Specifications ................................................................................................................................................9

Accessories..................................................................................................................................................................10

EQUIPMENT PREPARATION SECTION 2

Initial Startup...............................................................................................................................................................13

Connecting the Acquisition Module............................................................................................................................ 13

Loading Paper..............................................................................................................................................................14

A4 Paper Use With The ELI 250c ................................................................................................................15

Applying Power........................................................................................................................................................... 17

Setting Time and Date ................................................................................................................................................. 18

Using the WAM or AM12 Acquisition Module..........................................................................................................18

Installing the WLAN Antenna.....................................................................................................................................18

RECORD AN ECG SECTION 3

Patient Preparation.......................................................................................................................................................19

Patient Hookup ............................................................................................................................................................19

Patient Hookup Summary Table...................................................................................................................20

Patient Demographic Entry .........................................................................................................................................21

ECG Acquisition, Printing, Storage ............................................................................................................................22

Acquisition ...................................................................................................................................................22

Printing .........................................................................................................................................................23

Storage..........................................................................................................................................................24

Acquiring Rhythm Strips.............................................................................................................................................24

xix

TABLE OF CONTENTS

SYSTEM SETTINGS SECTION 4

Setting Technician Password....................................................................................................................................... 25

Configuration Menus................................................................................................................................................... 25

Summary of Configuration Menus..............................................................................................................................26

ECG DIRECTORY SECTION 5

ECG Directory............................................................................................................................................................. 39

ECG Order List............................................................................................................................................................40

CONNECTIVITY AND ECG TRANSMISSION APPENDIX A

ECG Transmission.......................................................................................................................................................41

Modem Transmission ..................................................................................................................................................42

Modem Initialization ....................................................................................................................................42

Modem Country Code List............................................................................................................................43

LAN Transmission ......................................................................................................................................................46

WLAN Transmission...................................................................................................................................................48

GPRS Mobile Transmission ........................................................................................................................................50

SIM Card Installation ...................................................................................................................................50

Retrieving ECGs..........................................................................................................................................................51

Orders Download ........................................................................................................................................................51

Custom ID Download..................................................................................................................................................52

USB Memory...............................................................................................................................................................52

Transmission using the USB host port to a USB memory stick....................................................................52

Transmission using the optional USBD (device) port to a PC......................................................................53

Connecting the ELI 150c or ELI 250c to a PC .............................................................................................53

MAINTENANCE AND TROUBLESHOOTING APPENDIX B

Troubleshooting Charts ...............................................................................................................................................55

Power Off the Device ..................................................................................................................................................57

Test Operation .............................................................................................................................................................57

Recommendations to Biomedical Staff .......................................................................................................................57

Battery Maintenance.................................................................................................................................................... 57

Cleaning the Thermal Printer ......................................................................................................................................58

xx

INTRODUCTION

Manual Purpose

This manual is intended to provide the user with information about:

• Using and understanding the ELI™ 150c or ELI 250c electrocardiograph, the function and feature keys,

and the display screen.

• Preparing the device for use. (Section 2)

• Acquiring, printing, and storing an ECG. (Section 3)

• System settings. (Section 4)

• Connectivity and transmitting ECGs. (Appendix A)

• Maintenance and troubleshooting. (Appendix B)

Audience

This manual is written for clinical professionals. They are expected to have working knowledge of medical
procedures and terminology as required for monitoring cardiac patients.

Indications for Use

• Device is indicated for use to acquire, analyze, display, and print electrocardiograms.

• Device is indicated for use to provide interpretation of the data for consideration by a physician.

• Device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the

orders of a licensed physician. It is not intended as a sole means of diagnosis.

• The interpretations of ECG offered by the device are only significant when used in conjunction with a

physician over-read as well as consideration of all other relevant patient data.

• Device is indicated for use on adult and pediatric populations.

• The device is not intended to be used as a vital signs physiological monitor.

SECTION 1

1

SECTION 1

System Description

The device is a 12-lead diagnostic electrocardiograph used for acquiring, viewing, and printing adult and pediatric
12-lead ECG data. The device is optionally equipped with Mortara Instrument’s VERITAS™ resting ECG
interpretation algorithm with age and gender specific criteria. If this option is enabled (see Section 4) the VERITAS
algorithm can provide an over-reading physician with a silent second opinion through diagnostic statements output
on the ECG report. For additional information on the VERITAS algorithm, please refer to the Physician’s Guide
Adult and Pediatric user manual. (See Accessories.)

The device can be configured with expanded memory, bidirectional connectivity, and DICOM
and operates on battery or line power.

Supported print formats for the ELI 150c include: standard or Cabrera 3, 3+1, 3+3, or 6 channel in automatic mode;
3 or 6 channel rhythm strip printing.

Supported print formats for the ELI 250c include: standard or Cabrera 3+1, 3+3, 6, 6+6, or 12 channel in automatic
mode; 3, 6, or 12 channel rhythm strip printing.

With either model, during rhythm strip printing the user can toggle between the various channels (default leads, limb
and chest leads, etc.) to print by selecting F2 (Leads). To suspend a rhythm strip print, press F6 (Stby); press
F6 (Cont) to resume. Press STOP at any time to end rhythm strip printing.

The device includes:

• Acquisition module with lead wire set

• Hospital-grade power cord

• Antenna (with WLAN or GPRS mobile)

• 1 pack paper

• 1 package of electrodes

• Physicians Guide Adult & Pediatric (with interpretation feature)

• User manual CD

• Accessory starter kit

®

protocol support,

2