Mortara ELI 150c, ELI 250c User manual

REF 9516-177-50-ENG Rev F1

ELI 150c/250c

12-LEAD RESTING ELECTROCARDIOGRAPH

SERVICE 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. 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.

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]

Mortara Instrument Germany

Bonifaciusring 15
45309 Essen
Germany
Tel: [phone]
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

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

TECHNICAL SUPPORT AND SERVICE

ii

TABLE OF CONTENTS

GENERAL INFORMATION SECTION 1

Notices ........................................................................................................................................................................... 1

Warranty Information .................................................................................................................................................... 2

User Safety Information ............................................................................................................................................... 3

Equipment Symbols and Markings .............................................................................................................................. 11

Electromagnetic Compatibility (EMC) ........................................................................................................................ 13

MAINTENANCE & CLEANING SECTION 2

Preventive Maintenance .............................................................................................................................................. 17

Device Cleaning & Disinfecting .................................................................................................................................. 20

Preventive Maintenance Record .................................................................................................................................. 21

DEVICE CONFIGURATION SECTION 3

Setting Technician Password ....................................................................................................................................... 23

Configuration Menus ................................................................................................................................................... 23

Summary of Configuration Menus .............................................................................................................................. 24

Configuration Settings ................................................................................................................................................. 27

UNIT DISASSEMBLY SECTION 4

Removal of the Unit from Cart .................................................................................................................................... 38

Cover Assembly Removal ........................................................................................................................................... 38

Writer Removal ........................................................................................................................................................... 39

Keyboard Removal ...................................................................................................................................................... 46

I/O Board Removal ...................................................................................................................................................... 49

Battery Replacement .................................................................................................................................................... 50

ELI 150c Item Description Listing .............................................................................................................................. 52

ELI 250c Item Description Listing .............................................................................................................................. 54

ELI 150c/250c Item Identification Table .................................................................................................................... 57

iii

TABLE OF CONTENTS

DEVICE SPECIFICATIONS SECTION 5

ELI 150c Specifications .............................................................................................................................................. 75

ELI 250c Specifications .............................................................................................................................................. 76

TROUBLESHOOTING SECTION 6

Troubleshooting Charts ............................................................................................................................................... 77

CONFORMANCE TESTING SECTION 7

Conformance Testing .................................................................................................................................................. 79

Power Testing .............................................................................................................................................................. 79

Functional Testing ....................................................................................................................................................... 80

Device Cleaning .......................................................................................................................................................... 81

Safety Testing .............................................................................................................................................................. 81

ELI 150c/250c Test Data Record ................................................................................................................................ 82

ELI 150c/250c COMMUNICATION OPTIONS SECTION 8

Communication Options .............................................................................................................................................. 83

Communication Error Messages.................................................................................................................................. 83

Communication Options (software only) .................................................................................................................... 84

Communication Options (Hardware + Software) ........................................................................................................ 84

iv

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.

1

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.

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.

2

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.

3

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 GSM/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 GSM/GPRS module operates in allocated frequency bands depending on the model. Identification

of the installed GSM/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)

4

USER SAFETY INFORMATION

 Use of the GSM/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 GSM/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 GSM 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 GSM/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.

5

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.

6

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.
60601-1-1-02, 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 GSM/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 in the 2.4 GHz or 5ghz range. Other nearby wireless devices 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.

7

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 Region Frequency

Range (GHz)

15 dBm / 32 mW USA/Can ad a 2.401 - 2.473 11

802.11b

13 dBm / 18 mW USA/Can ad a 2.401 - 2.473 11

802.11g

17 dBm / 50 mW USA/Canada 5.15 - 5.35,

802.11a

Europe 2.401 - 2.483 13
Japan 2.401 - 2.495 14

Europe 2.401 - 2.483 13
Japan 2.401 - 2.483 13

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,
19 36,40,44,48,52,56,60,64,100,

23 36,40,44,48,52,56,60,64,100,

Channel numbers

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

153,157,161,165
104,108,112,116,120,124,

128,132,136,140
104,108,112,116,120,124,

128,132,136,140,184188,
192,196

149,153,157,161,165

8

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.

9

USER SAFETY INFORMATION

10

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

11

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

12

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 the appropriate 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.

13

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 Electromag n etic 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.

14

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 surveya, should

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. 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.

15

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 , o bj ect s, an d pe o pl e.

16

MAINTENANCE & CLEANING

SECTION 2

Preventive Maintenance

Preventive maintenance is recommended to be performed on the ELI150c/250c once every 12
months.

Warning: Preventive maintenance is to be performed by Mortara authorized service personnel

only.

2.0 Maintenance Procedure

2.1 Turn unit on and print the device configuration per section 3 of this manual. Attach a
copy to the Preventive Maintenance Report.

2.2 Remove the unit cover per section 4 of this manual.

2.3 Perform a visual inspection of the following items:

2.3.1 Enclosure/Housing – Look for damage or cracks in the external housing or

enclosure that could possibly expose the device to the introduction of foreign
objects or fluids. Attention should also be paid to areas that could expose an
operator or patient to internal circuitry of the device.

2.3.2 Contamination – Look for any contamination that may have occurred over time

that could not be seen with the housing in place.

 Fluid damage (perhaps caused during device cleaning)
 Debris on or behind display shield
 Battery leakage (lithium and main battery)

2.3.3 Internal Cabling – Look for cracked, pinched or partially disconnected cable

connections.

2.3.4 Fuse Ratings – Verify PCB mounted fuses (items 23 and 24) the meet the

specifications defined in the item description listing.

2.3.5 Markings and Labeling – Verify all labels and device markings are clearly visible

and legible to the device user and have not been worn off or rendered
unreadable through the use of harsh cleaning agents.

2.3.6 Integrity of Mechanical Parts – Verify the following items are properly secured to

the device and have not become loose or damaged through usage over time.

 AC Inlet
 Patient Input Connector
 Communication ports and antenna
 Writer mechanics/latching mechanism

2.4 Power Testing

* Based upon customer usage and age of battery, replace as needed.

2.4.1 Ensure battery is fully charged before performing these tests, voltage and current

limits are based on a fully charged battery.

2.4.2 Ensure there is no power connected to the UUT AC inlet.

2.4.3 Remove upper housing and writer assembly. Disconnect battery by pulling

battery cable off of the red terminal.

17

SECTION 2

2.4.4 Note battery age (if possible)

This information can be found on the white “date code” sticker located on the
battery (use the earliest date that is not crossed out).

2.4.5 Battery (open circuit)

Measure battery voltage using a voltage meter; verify the meter reads greater
than 12.5vdc.

2.4.6 Battery (load)

Measure the battery voltage using a volt meter and a power resistor load
(10ohm, 20watt) in parallel with the battery. After approximately 5 seconds,
verify the meter reads greater than 11.7vdc.

2.4.7 Off current

Connect a current meter in line with battery. With the UUT power off, verify the
current meter reads less than 100 micro amps.

2.4.8 On current

Turn on the unit and verify the current meter reads less than 250 milli amps.

2.4.9 AC charging current

Apply AC power to the unit and verify that the current draw from the battery
reverses polarity and the value starts decreasing as time increases.

2.4.10 Battery charger output voltage

Disconnect the current meter and measure the battery charger output voltage
between the red disconnected battery cable and the negative terminal on the
battery. It should read between 13.0vdc and 14.0vdc.

2.5 Verify all power cables are reconnected properly

2.6 Reassemble unit in reverse order of disassembly

2.7 Functional Testing

2.7.1 AC LED/Display

Connect AC power cord to the unit and verify that the green AC LED (located to
the left of the display) illuminates continuous.
NOTE: The battery indicator will be clear when charging and will illuminate white
when fully charged.
Verify text on display is clear and legible and there are no flickering or missing
lines/pixels.

2.7.2 Writer

Open and close the writer door to verify smooth operation. Verify that the door
unlatches without sticking and that it latches completely. From the main screen,
simultaneously press shift+alt+RHY. Verify that a test page is printed and the
writer stops on the cue mark. The perforation of the paper should line up with the
tear edge on the writer. Assure there are no gaps in the printing and the print
darkness is uniform across the entire page. Verify the writer gears do not skip
and paper is tracking properly (you may need to print multiple pages to observe
this).

18

SECTION 2

2.7.3 ECG & Keyboard Matrix

Connect an ECG simulator to the AM12 or WAM patient interface. Set the
simulator to a known heart rate and amplitude; preferably to a setting that you
have a “known good” printout for comparison. Press the ECG key to capture an
ECG. Verify there is an audible beep with each key press. Enter Last name
“PARCFL8” (Note: “PARCFL8” ensures the keyboard matrix is fully tested), then
press F6 (Done). Verify that 12 ECG traces print correctly and assess the
printout quality. Ensure uniform darkness across entire printout.

2.7.4 ECG Noise Test

Connect a Shorting Block (TF-0063) and adapter or equivalent to the AM12 or
WAM patient interface. Set the ECG gain on the unit to 20mm/mV. Print a
rhythm strip (approx. 1 page). Verify that no channels have more than 0.5mm of
noise.

2.7.5 Communication options

Verify successful transmission of all applicable communication options by
transmitting the ECG record stored in step 2.7.3 to a compatible receiving device:

 Modem
 LAN
 WLAN
 GSM/GPRS
 USB
 USBD

2.8 Clean unit per the instructions provided on the following page of this section of the service

manual.

2.9 Safety Testing

The following safety tests should be performed in accordance with all local regulatory
requirements:

 Earth Leakage
 Enclosure Leakage
 Patient Leakage
 Patient Auxiliary Current

19

SECTION 2

Device Cleaning & Disinfecting

Warning:

 Use of non-recommended cleaning agents or practices could cause damage to the device or

possible compromising of the electrical isolation of the device.

 Makes sure all cables and accessories a re disconnected from the device prior to performing

cleaning process.

 Do not immerse the device in liquid.
 Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents that may

damage equipment surfaces.

 Do not use excessive amounts of liquid during cleaning or di sinfecting of the device, as these

fluids could enter the device housing and cause damage to the device.

Recommended Supplies:

 Clean lint free cloth
 Mild detergent
 Luke warm water
 10% Household bleach and water solution (Sodium Hypochlorite solution consisting of a

minimum 1:500 dilution and maximum of 1:10 dilution for disinfecting use only)

Device Cleaning:

Disconnect the AC power cord from the device. Clean the exterior surface of the device with a damp (not
wet), soft, lint-free cloth using a solution of mild detergent diluted in luke warm water. After cleaning,
thoroughly dry off the device with a clean, soft cloth or paper towel.

Device Disinfecting:

Clean the device per the instructions defined above, then wipe the exterior of the device with a damp (not
wet), soft, lint-free cloth using a solution of 10% bleach and water. Allow the device to air dry after
disinfecting before returning to use.

20

Mortara Instrument, Inc. Phone [phone]
7865 N. 86
Milwaukee, WI. 53224

th

Street Fax [phone]

Mortara Instrument Inc.

ELI 150/250c Preventive Maintenance Report

Unit Serial #: _________________________________________

□ Print device configuration (attach to this report)

□ Remove the units upper housing

□ Perform Visual Inspection

□ Enclosure/Housing
□ Contamination
□ Cabling
□ Fuse Ratings
□ Markings and Labeling
□ Integrity of Mechanically Parts

□ Power Testing
□ Note Battery Age (If Possible) _____/_____ (week/year)
□ Battery (Open Circuit) Voltage _______ VDC
□ Battery (with Load) Voltage _______ VDC
□ Off Current _______ uA
□ On Current _______ A

□ Battery Charger Output Voltage _______ VDC

* Based upon customer usage and age of main battery, replace as needed.

□ Verify all power cables are properly reconnected and reassemble unit

□ Functional testing

□ AC LED/Display Functionality
□ Writer Test
□ ECG & Keyboard Matrix Testing
□ ECG Noise Test
□ Communication Options

□ Device Cleaning

□ Safety Testing PASS / FAIL (circle)

□ Earth Leakage
□ Enclosure Leakage
□ Patient Leakage
□ Patient Auxiliary Current

Technician or Field Service Engineer: ____________________________ Date: _____/_____/_____

21