Mortara ELI 280 User manual

REF 9515-181-50-ENG Rev E1

ELI 280

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 © 2015

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. AM12, ELI,
E-Scribe, VERITAS, and WAM are trademarks of Mortara Instrument, Inc. DICOM is the registered trademark of
the National Electrical Manufacturers Association for its standards publications relating to digital communications
of medical information. V1.10.

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 Instrument Europe, s.r.l.

(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]

Sales Support/
Supplies & Accessories

Mortara Instrument, Inc.

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

Hospital Customers: [e-mail]
Physician Practice: [e-mail]
U.S. Distribution: [e-mail]

Mortara Instrument Germany

Bonifaciusring 15
45309 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]

Mortara Dolby UK Ltd.

Units 11 & 12, Scion House
Stirling University Innovation Park
Stirling FK9 4NF
Scotland
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 bottom 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. (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.

iii

WARRANTY INFORMATION

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.

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.

 Only use parts and accessories supplied with the device and/or are available through Mortara Instrument, Inc.
 Patient acquisition devices intended for use with the device include series resistance (9 Kohm minimum) in

each lead for defibrillation protection. Patient acquisition devices should be checked for cracks or breakage
prior to use.

 Conductive parts of the Patient acquisition device, electrodes, and associated connections of type CF applied

parts, including the neutral conductor of the Patient acquisition device 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 acquisition devices. Additionally, proper placement of defibrillator paddles in relation to the
electrodes is required to minimize harm to the patient.

 This device does not automatically switch between direct or wireless Patient acquisition devices. Clinician

must choose Patient acquisition device before ECG acquisition. If your device is equipped with a receiver for a
wireless Patient acquisition device, always make sure that you are receiving data from the expected module.

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.

 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.

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

connecting the device to a network.

 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 280 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 280 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 280 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.

vi

USER SAFETY INFORMATION

 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.

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

 Quatech, Inc. Model WLNG-AN-MR551: 2400 MHz

(model subject to change without notice)

 Use of the 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 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 WLAN 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 WLAN module complies 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

vii

USER SAFETY INFORMATION

Caution(s)

 To prevent possible damage to the touchscreen, do not use sharp objects to touch the screen icons, only use

fingertips.

 Do not attempt to clean the device or patient acquisition device 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 acquisition device as this could result in mechanical and/or electrical failures.

Patient cables should be stored after forming them into a loose loop.

 Calibration of the display is required before initial operation of the unit. No special equipment is 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.

 Proper functioning backup items such as a spare patient cable, front-end device, display monitor, and other

equipment are recommended on hand to prevent delayed treatment due to an inoperable device.

Note(s)

 Patient movement 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.

 The display of a thick baseline while using the WAM wireless acquisition module (square waves on rhythm

printout) could be due to the WAM being turned off or having no battery, or the WAM being out of range or
experiencing a calibration error. Review the LED indicator on the WAM to ensure the unit is turned on and has
proper battery level. Ensure the WAM is paired correctly and is within recommended proximity of the
electrocardiograph, and/or power cycle the WAM to re-calibrate. Review the WAM user manual for details.

viii

USER SAFETY INFORMATION

 The display of a thick baseline while using the AM12 acquisition module (square waves on rhythm printout)

could be due to an improper auto-calibration. Reconnect the AM12 or power cycle the electrocardiograph.

 A square wave on the display and rhythm printout could be due to the WAM, the AM12, or lead wires not

being connected to the patient.

 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

 The device will automatically turn off (blank screen) if the batteries have been severely discharged and the AC

mains is disconnected from the device.

 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.

 WAM must be paired to electrocardiograph before operation.
 The device must be configured at the factory for use with the WAM.
 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

ix

USER SAFETY INFORMATION

Wireless Data Transmission

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

(WLAN or GSM). 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 in the 2.4 GHz or 5 GHz range. Other nearby wireless devices in the same frequency

range may cause interference. If possible, move or turn off other devices to minimize potential interference.

 The Wireless LAN module used is compliant with the IEEE 802.11 a, b, g and n standards.
 Access Points used should respect IEEE 802.11 standards as well as local Radio Frequency regulations. The

device will scan the available channels and connect to the Access Point on the channel where the SSID that is
configured on the device is available.

x

USER SAFETY INFORMATION

 The following table shows the radio channels allocated in different geographic areas in the world. For bands

802.11b and g, only channels 1, 6, 11 and 14 (Japan only) are non-overlapping; for band 802-11a, channels
shown represent non-overlapping channel numbers.

Band Typical

Power

15 dBm /

802.11b

802.11g

802.11a

32 mW

13 dBm /
18 mW

17 dBm /
50 mW

 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 such situations it is
recommended to move the device to a proper location where the WLAN frequencies are available.

Region Frequency

Range (GHz)

USA/Canada 2.401 - 2.473 11
Europe 2.401 - 2.483 13
Japan 2.401 - 2.495 14
USA/Canada 2.401 - 2.473 11
Europe 2.401 - 2.483 13
Japan 2.401 - 2.483 13
USA/Canada 5.15 - 5.35,

5.725 - 5.825

Europe 5.15 - 5.35,

5.47 - 5.725

Japan 4.91 – 4.99,

5.15 - 5.35,

5.47 - 5.725

China 5.725 - 5.825 5

No. of
channels

13 36,40,44,48,52,56,60,64,149,153,157,
19 36,40,44,48,52,56,60,64,100,104,108,
23 36,40,44,48,52,56,60,64,100,104,108,

Channel numbers

1 – 11
1 – 13
1 – 14
1 – 11
1 – 13
1 – 13

161,165
112,116,120,124,128,132,136,140
112,116,120,124,128,132,136,140,184

188,192,196
149,153,157,161,165

xi

USER SAFETY INFORMATION

xii

EQUIPMENT SYMBOLS AND MARKINGS

Symbol Delineation

Attention, consult accompanying documents

Alternating current

Protective earth symbol (appears on inside of unit)

Fuse symbol (appears on inside of unit)

Telephone line (modem)

Network (LAN)



Universal Serial Bus (USB)

Defibrillator-proof type CF applied part

Input

ON/OFF (power)

Shift key (to enter upper case text on keyboard)

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

xiii

EQUIPMENT SYMBOLS AND MARKINGS

Initiate acquisition of ECG

Initiate printing of continuous rhythm strip

Initiate transmission of records

Stop rhythm print out

Configuration (Settings) menu

Home (returns user to the real-time acquisition screen)

xiv

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 Acquisition Device

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.

xv

GENERAL CARE

xvi

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 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.

xvii

ELECTROMAGNETIC COMPATIBILITY (EMC)

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 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

Harmonic Emissions
IEC 61000-3-2

Complies

domestic purposes.

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

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.

xviii

ELECTROMAGNETIC COMPATIBILITY (EMC)

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.

xix

ELECTROMAGNETIC COMPATIBILITY (EMC)

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.

xx

TABLE OF CONTENTS

INTRODUCTION SECTION 1

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

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

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

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

Figure 1-1, System Illustration ...................................................................................................................................... 3

Figure 1-2, Side View.................................................................................................................................................... 3

Figure 1-3, Rear View ................................................................................................................................................... 4

Figure 1-4, Base View ................................................................................................................................................... 4

Display Overview .......................................................................................................................................................... 5

Function Control Icons .................................................................................................................................... 6

Specifications ................................................................................................................................................................ 7

Accessories .................................................................................................................................................................... 8

EQUIPMENT PREPARATION SECTION 2

Initial Startup ............................................................................................................................................................... 11

Calibrating the Touchscreen Display .......................................................................................................................... 11

Connecting the Acquisition Module ............................................................................................................................ 11

Loading Paper .............................................................................................................................................................. 12

Powering the ELI 280 .................................................................................................................................................. 15

Low Battery Failsafe Conditions ................................................................................................................................. 16

Power Status ................................................................................................................................................................ 16

Setting Date and Time ................................................................................................................................................. 17

Time Synchronization.................................................................................................................................................. 17

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

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

RECORD AN ECG SECTION 3

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

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

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

Optional Bar Code Scanner ......................................................................................................................................... 22

ECG Acquisition and Printing with WAM or AM12 .................................................................................................. 23

ECG Acquisition ......................................................................................................................................................... 23

Best 10 Seconds of ECG ............................................................................................................................................. 26

Configuring the ECG Report ....................................................................................................................................... 26

Acquired ECG Storage ................................................................................................................................................ 27

Acquiring Rhythm Strips ............................................................................................................................................. 27

xxi

TABLE OF CONTENTS

CONNECTIVITY AND ECG TRANSMISSION SECTION 4

ECG Transmission ....................................................................................................................................................... 29

Internal Modem Connection ........................................................................................................................................ 30

External Modem Country Code List ............................................................................................................. 31

Local Area Network (LAN) Connection and Setup .................................................................................................... 34

Wireless Local Area Network (WLAN) Connection and Setup ................................................................................. 35

Transmission Media Auto Sync .................................................................................................................................. 36

USB Connectivity ........................................................................................................................................................ 37

ECG DIRECTORY SECTION 5

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

Searching ECG Records .............................................................................................................................................. 39

Reviewing ECG Records ............................................................................................................................................. 40

Deleting ECG Records ................................................................................................................................................ 41

Erasing ECGs from the Directory ............................................................................................................................... 41

Printing the ECG Directory ......................................................................................................................................... 41

ECG Orders ................................................................................................................................................................. 41

Searching ECG Orders ................................................................................................................................................ 42

Worklist Management ................................................................................................................................................. 42

Sync Command ........................................................................................................................................................... 42

MWL Query ................................................................................................................................................................ 43

Custom ID Download .................................................................................................................................................. 43

SYSTEM SETTINGS SECTION 6

Menu Commands and Utilities .................................................................................................................................... 45

Security ........................................................................................................................................................................ 47

Setting Passwords ......................................................................................................................................... 47

Configuration Settings: About .................................................................................................................................... 47

Configuration Settings: Modem ................................................................................................................................. 49

Configuration Settings: System .................................................................................................................................. 49

Configuration Settings: ECG ...................................................................................................................................... 51

Configuration Settings: LAN ..................................................................................................................................... 55

Configuration Settings: WLAN .................................................................................................................................. 56

Configuration Settings: Date/Time ............................................................................................................................. 57

Configuration Settings: Custom ID ............................................................................................................................ 58

Configuration Settings: Network ................................................................................................................................ 58

Configuration Settings: WAM ................................................................................................................................... 58

Configuration Settings: Service .................................................................................................................................. 58

MAINTENANCE AND TROUBLESHOOTING APPENDIX A

Troubleshooting Charts ............................................................................................................................................... 59

Power Off the Device .................................................................................................................................................. 62

Test Operation ............................................................................................................................................................. 62

Recommendations to Biomedical Staff ....................................................................................................................... 62

Battery Maintenance .................................................................................................................................................... 62

Cleaning the Thermal Printer ...................................................................................................................................... 63

Cleaning the Touchscreen ........................................................................................................................................... 63

xxii

INTRODUCTION

SECTION 1

Manual Purpose

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

• Using and understanding the ELI™ 280 electrocardiograph, the touchscreen display, and the function

control icons.

• Preparing the ELI 280 for use. (Section 2)

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

• Connectivity and transmitting ECGs. (Section 4)

• Maintaining the ECG directory. (Section 5)

• System settings. (Section 6)

• Maintenance and troubleshooting. (Appendix A)

NOTE: This manual may contain screen shots. Any screen shots are provided for reference only and are
not intended to convey actual operating techniques. Consult the actual screen in the host language for
specific wording.

Audience

This manual is written for clinical professionals with a 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.

1

SECTION 1

System Description

The device is a 12-lead diagnostic electrocardiograph capable of acquiring, viewing, transmitting, printing, and
storing 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 6) 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 to
VERITAS with Adult and Pediatric Resting ECG Interpretation (see Accessories).

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

Supported print formats for the ELI 280 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.

During rhythm strip printing the user can toggle between the various channels (default leads, limb and chest leads,
etc.). To begin or resume a suspended rhythm strip print, press
end a rhythm strip print, press

The device includes:

• WAM™ or AM12™ acquisition module with lead wire set

• Hospital-grade power cord

• Antenna (with WLAN option)

• 1 pack paper (standard or A4)

• Physician’s Guide to VERITAS with Adult and Pediatric Resting ECG Interpretation

• User manual CD

• Accessory starter kit

from the touchscreen display

from the touchscreen display. To suspend or

.

®

protocol

2

System Illustration

Figure 1-1

Side View

Figure 1-2

SECTION 1

Writer Handle

3