Manual de Uso de Monitor Mortara
Manual de Uso de Monitor Mortara
Manual de Uso de Monitor Mortara
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Copyright © 2018
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® is the registered trademark of Cisco Systems, Inc.
DICOM® is the registered trademark of the National Electrical Manufacturers Association for its standards
publications relating to digital communications of medical information. V2.1.0. 2016-2
TECHNICAL SUPPORT AND SERVICE
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 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.
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.
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
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;
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
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(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 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.
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 150c and ELI 250c are medical devices that have 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 150c/ELI 250c 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 150c/ELI 250c 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.
vi
USER SAFETY INFORMATION
• To prevent electric shock due to unequal ground potentials that may exist between points of a distributed
network system or fault conditions in external network connected equipment, network cable shielding
(where used) must be connected to protective earth ground appropriate to the area where the device is used.
• The device has not been designed for use with high-frequency (HF) surgical equipment and does not provide a
protective means against hazards to the patient.
• When the 40 Hz filter is used, the frequency response requirement for diagnostic ECG equipment cannot be
met. The 40 Hz filter significantly reduces high-frequency components of the ECG and pacemaker spike
amplitudes, and is recommended only if high-frequency noise cannot be reduced by proper procedures.
• The quality of the signal produced by the device may be adversely affected by the use of other medical
equipment, including but not limited to defibrillators and ultrasound machines.
• For proper operation and the safety of users or patients and bystanders, equipment and accessories must be
connected only as described in this manual. Do not connect a telephone line cable to the LAN connector.
• Some Mortara electrocardiographs can be equipped with a GPRS (cellular modem) or wireless LAN (WLAN)
module for transmitting ECG records. Device labeling and the presence of an antenna port will indicate if your
device is equipped with such a module. If so equipped, the following notices apply:
• The GPRS module operates in allocated frequency bands depending on the model. Identification of
the installed GPRS module can be found on a label on the bottom of the device.
• MultiTech Systems, Inc. Model MTSMC-H5: 850/900/1700(AWS)/1900/2100 MHz
• The WLAN identification can be found on a label on the bottom of the device.
• B&B Electronics Model WLNN-AN-MR551: 2400 MHz
(model subject to change without notice)
• Use of the GPRS or WLAN module may interfere with other equipment operating in the vicinity. Check with
local authorities or spectrum management officials in your facility to determine if restrictions apply to the use of
this feature in your area.
• Do not transmit via the GPRS or WLAN module with a missing or damaged antenna. Replace a damaged
antenna immediately.
• Use only the antenna supplied for use with this device. Unauthorized antennas, modifications, or attachments
could damage the GPRS module and may contravene local RF emission regulations or invalidate type approval.
• To ensure compliance with current regulations limiting both maximum RF output power and human exposure
to radio frequency radiation, a separation distance of at least 20 cm must be maintained between the device's
antenna and the head and body of the user and any nearby persons at all times. To help prevent degradation of
RF signal and to avoid excess RF energy absorption, do not touch the antenna during data transmission.
• The GPRS and WLAN modules comply with applicable RF safety standards including standards and
recommendations for the protection of public exposure to RF electromagnetic energy that have been established
by governmental bodies and other qualified organizations, such as the following:
• Federal Communications Commission (FCC)
• Directives of the European Community
• Directorate General V in Matters of Radio Frequency Electromagnetic Energy
vii
USER SAFETY INFORMATION
• Proper functioning backup items such as spare lead wires, front-end device, and other equipment are
recommended on hand to prevent delayed treatment due to an inoperable device.
viii
USER SAFETY INFORMATION
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.
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.
• A square wave presentation on the display while using the WAM may be due to the WAM being turned off,
having no battery, not being paired correctly, operating out of range, or due to a calibration error. Review the
LED indicator on the WAM to ensure the unit is turned on, has proper battery level, is paired correctly, and is
within recommended proximity of the electrocardiograph, or power cycle the WAM to re-calibrate.
ix
USER SAFETY INFORMATION
• A square wave presentation on the display while using the AM12 may be due to improper auto-calibration.
Power cycle the AM12 or the electrocardiograph.
• 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:
• 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.
• The device is a member of the ELI 1xx or ELI 2xx Series 2 electrocardiograph family.
x
USER SAFETY INFORMATION
• Some Mortara electrocardiographs can be equipped with an optional wireless data transmission module
(WLAN or GPRS mobile). Both these technologies use radios to transmit data to a Mortara receiving
application. Due to the nature of radio transmissions, it’s possible that, due to the characteristics of the
environment where the device is located, some other RF sources may interfere with the transmission generated
by the device. Mortara Instrument has tested the coexistence of the device with other devices that can interfere
such as devices using WLAN, Bluetooth radio, and/or cell phones. Although the current technology allows a
very successful rate of transmission, it’s possible that in some rare occurrences, the system may not perform at
its best resulting in a “failed transmission.” When this occurs, patient data will not be erased from the device
nor stored in the receiving application, ensuring that partial or corrupted data are not made available to the
receiving station. If the failure mode persists the user should move to a position where the RF signals may
propagate better and allow successful transmissions.
WLAN Option
• Wireless options transmit 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.
xi
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.
• 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.
xii
USER SAFETY INFORMATION
xiii
EQUIPMENT SYMBOLS AND MARKINGS
Symbol Delineation
Alternating current
Protective earth
Network (LAN)
USB port
Input
ON/OFF (power)
xiv
EQUIPMENT SYMBOLS AND MARKINGS
Antenna
xv
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.
Clorox Healthcare® Bleach Germicidal Wipes (use according to instructions on product label), or
a soft, lint-free cloth with 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
CAUTION:
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.
Do not sterilize the device or lead wires with Ethylene Oxide (EtO) gas.
Do not immerse cable ends or lead wires; immersion can cause metal corrosion. Use caution with excess
liquid as contact with metal parts may cause corrosion.
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.
xvi
GENERAL CARE
NOTE: Do not let soap or water come into contact with the writer, plugs, jacks, or vents.
xvii
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 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.
xviii
ELECTROMAGNETIC COMPATIBILITY (EMC)
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.
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 low-
voltage power supply network that supplies buildings used for
Harmonic Emissions Complies domestic purposes.
IEC 61000-3-2
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.
Electrostatic +/- 6 kV contact +/- 6 kV contact Floors should be wood, concrete, or ceramic
discharge (ESD) +/- 8 kV air +/- 8 kV air tile. If floors are covered with synthetic
IEC 61000-4-2 material, the relative humidity should be at
least 30%.
Electrical fast +/- 2 kV for +/- 2 kV for Mains power quality should be that of a
transient/burst power supply lines power supply lines typical commercial or hospital environment.
IEC 61000-4-4 +/- 1 kV for +/- 1 kV for
input/output lines input/output lines
Surge +/- 1 kV differential +/- 1 kV differential Mains power quality should be that of a
IEC 61000-4-5 mode mode typical commercial or hospital environment.
+/- 2 kV common +/- 2 kV common
mode mode
Voltage dips, <5% UT <5% UT Mains power quality should be that of a
short (>95% dip in UT) (>95% dip in UT) typical commercial or hospital environment.
interruptions, for 0.5 cycle for 0.5 cycle
and voltage 40% UT 40% UT
variations on (60% dip in UT) (60% dip in UT)
power supply for 5 cycles for 5 cycles
input lines
IEC 61000-4-11
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be at
(50/60 Hz) levels characteristic of a typical location in a
magnetic field typical commercial or hospital environment.
NOTE: UT is the AC Mains voltage prior to application of the test level.
xix
ELECTROMAGNETIC COMPATIBILITY (EMC)
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.
3.5
d= P
Conducted RF 3 Vrms 3 Vrms 3Vrms
IEC 61000-4-6 150 kHz to 150 kHz to
80 MHz 80 MHz
3.5 80 MHz to 800 MHz
d= P
3V / m
Radiated RF 3 V/m 3 V/m
IEC 61000-4-3 80 MHz to 80 MHz to
7 800 MHz to 2.5 GHz
2.5 GHz 2.5 GHz d= P
3V / m
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.
xx
ELECTROMAGNETIC COMPATIBILITY (EMC)
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 Separation Distance According to Frequency of Transmitter (m)
of Transmitter W
d = 1.2 P d = 2.3 P
0.01 0.1 m 0.2 m
1 1.2 m 2.3 m
10 4.0 m 7.0 m
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where 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.
xxi
TABLE OF CONTENTS
INTRODUCTION SECTION 1
Manual Purpose ............................................................................................................................................................. 1
Audience ........................................................................................................................................................................ 1
Indications for Use......................................................................................................................................................... 1
System Description ........................................................................................................................................................ 2
System Illustrations ....................................................................................................................................................... 3
Display and Keyboard ................................................................................................................................................... 5
Automatic Feature Keys .................................................................................................................................. 5
Display Overview .......................................................................................................................................................... 6
ELI 150c Specifications ................................................................................................................................................. 8
ELI 250c Specifications ................................................................................................................................................. 9
Accessories .................................................................................................................................................................. 10
xxii
TABLE OF CONTENTS
xxiii
INTRODUCTION
SECTION 1
Manual Purpose
• Using and understanding the ELI™ 150c or ELI 250c electrocardiograph, the function and feature keys,
and the display screen.
• Preparing the device for use. (Section 2)
• Acquiring, printing, and storing an ECG. (Section 3)
• System settings. (Section 4)
• Connectivity and transmitting ECGs. (Appendix A)
• Maintenance and troubleshooting. (Appendix B)
NOTE: This manual may contain screen shots. Any screen shots are provided for reference only. Consult
the actual screen in the host language for specific wording.
Audience
This manual is written for clinical professionals. They are expected to have working knowledge of medical
procedures and terminology as required for monitoring cardiac patients.
• 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 used for acquiring, viewing, and printing adult and pediatric
12-lead ECG data. The device is optionally equipped with Mortara Instrument’s VERITAS™ resting ECG
interpretation algorithm with age and gender specific criteria. If this option is enabled (see Section 4) the VERITAS
algorithm can provide an over-reading physician with a silent second opinion through diagnostic statements output
on the ECG report. For additional information on the VERITAS algorithm, please refer to the Physician’s Guide
Adult and Pediatric user manual. (See Accessories.)
The device can be configured with expanded memory, bidirectional connectivity, and DICOM® protocol support,
and operates on battery or line power.
Supported print formats for the ELI 150c include: standard or Cabrera 3, 3+1, 3+3, or 6 channel in automatic mode;
3 or 6 channel rhythm strip printing.
Supported print formats for the ELI 250c include: standard or Cabrera 3+1, 3+3, 6, 6+6, or 12 channel in automatic
mode; 3, 6, or 12 channel rhythm strip printing.
With either model, during rhythm strip printing the user can toggle between the various channels (default leads, limb
and chest leads, etc.) to print by selecting F2 (Leads). To suspend a rhythm strip print, press F6 (Stby); press
F6 (Cont) to resume. Press STOP at any time to end rhythm strip printing.
2
SECTION 1
System Illustrations*
Figure 1-1
3
SECTION 1
4
SECTION 1
Figure 1-5
ECG Acquisition
Rhythm Printing
Stop
5
SECTION 1
Display Overview
The device features a ¼ VGA 320 x 240 pixels LCD color display for valuable preview of ECG waveform, function
key labels, and other parameters as explained below. During ECG acquisition, notification messages will also
appear on the display. (See Section 3, ECG Acquisition, Printing, Storage.)
Figure 1-6
When a patient is connected to the electrocardiograph, his/her HR is displayed in real time. The HR is the average
ventricular rate measured over an average of the patient’s last five beats.
Speed:
Use F3 (Speed) to select display speed or rhythm printout speed: 5 mm/s, 10 mm/s, 25 mm/s, or 50mm/s. Paper
speed is printed at the bottom right corner of the ECG printout.
Gain:
Use F4 (Gain) to select waveform amplitude for display and printout: 5 mm/mV, 10 mm/mV, or 20 mm/mV. Gain
is printed at the bottom right corner of the ECG printout.
6
SECTION 1
Filter:
Use F5 (Filt) to select the low-pass filter options: 40 Hz, 150 Hz, or 300 Hz for ECG printouts. Filter is printed at
the bottom right corner of the ECG printout.
WARNING: 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.
Function Keys:
Function keys activate the LCD label adjacent to each function key. LCD labels/functions change depending upon
the screen displayed. If the label is blank, the function key is not active.
Battery Indicator:
Acquisition Module:
Clock:
Time display with hour, minutes, and seconds resolution. (See Section 2 for setting a new time and date.) When the
ECG is acquired, the time displayed is the printed ECG acquisition time.
7
SECTION 1
Feature Specifications
Instrument Type 12-lead electrocardiograph
Input Channels Simultaneous acquisition of all 12 leads
Standard Leads Acquired I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
Waveform Display Backlit, ¼ VGA color LCD (320 x 240);
3, 4+4, or 6+6 lead presentation
Input Impedance Meets or exceeds requirements of ANSI/AAMI/IEC 60601-2-25
Input Dynamic Range
Electrode Offset Tolerance
Common Mode Rejection
Pacemaker Pulse Display
Patient Leakage Current Meets or exceeds requirements of ANSI/AAMI ES1
Chassis Leakage Current
Digital Sampling Rate 40,000 s/sec/channel used for pacemaker spike detection;
1000 s/sec/channel used for recording and analysis
Optional Functions Mortara VERITAS resting ECG interpretation algorithm with age and
gender specific criteria; connectivity with bidirectional communication
Paper Perforated double Z-fold thermal paper; 108 mm (4”) wide, 200 sheets
Thermal Printer Computer-controlled dot array; 8 dots/mm
Thermal Printer Speeds 5, 10, 25, or 50 mm/s
Gain Settings 5, 10, or 20 mm/mV
Report Print Formats Standard or Cabrera; 3, 3+1, 3+3, or 6 channel
Rhythm Print Formats 3 or 6 channel with configurable lead groups
Keyboard Elastomer keyboard with complete alphanumeric keys, soft-key menu, and
dedicated function keys
Frequency Response 0.05 to 300 Hz
Filters High-performance baseline filter; AC interference filter 50/60 Hz; low-pass
filters 40 Hz, 150 Hz, or 300 Hz
A/D Conversion 20 bits (1.17 microvolt LSB)
Device Classification Class I, Type CF defibrillation-proof applied parts
ECG Storage Internal storage up to 40 ECGs; optional expanded up to 200 ECGs
Weight 7.2 lbs. (3.3 kg) including battery (without paper)
Dimensions 11.25 x 11.5 x 3.75” (29.2 x 30.5 x 10.2 cm)
Power Requirements Universal AC power supply (100-240 VAC at 50/60 Hz) 110 VA; internal
rechargeable battery
8
SECTION 1
Feature Specifications
Instrument Type 12-lead electrocardiograph
Input Channels Simultaneous acquisition of all 12 leads
Standard Leads Acquired I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
Waveform Display Backlit, ¼ VGA color LCD (320 x 240);
3, 4+4, or 6+6 lead presentation
Input Impedance Meets or exceeds requirements of ANSI/AAMI/IEC 60601-2-25
Input Dynamic Range
Electrode Offset Tolerance
Common Mode Rejection
Pacemaker Pulse Display
Patient Leakage Current Meets or exceeds requirements of ANSI/AAMI ES1
Chassis Leakage Current
Digital Sampling Rate 40,000 s/sec/channel used for pacemaker spike detection;
1000 s/sec/channel used for recording and analysis
Optional Functions Mortara VERITAS resting ECG interpretation algorithm with age and
gender specific criteria; connectivity with bidirectional communication
Paper Perforated Z-fold thermal paper; A4 or 8.5 x 11” wide, 250 sheets
Thermal Printer Computer-controlled dot array; 8 dots/mm
Thermal Printer Speeds 5, 10, 25, or 50 mm/s
Gain Settings 5, 10, or 20 mm/mV
Report Print Formats Standard or Cabrera; 3+1, 3+3, 6, 6+6, or 12 channel
Rhythm Print Formats 3, 6, or 12 channel with configurable lead groups
Keyboard Elastomer keyboard with complete alphanumeric keys, soft-key menu,
and dedicated function keys
Frequency Response 0.05 to 300 Hz
Filters High-performance baseline filter; AC interference filter 50/60 Hz; low-
pass filters 40 Hz, 150 Hz, or 300 Hz
A/D Conversion 20 bits (1.17 microvolt LSB)
Device Classification Class I, Type CF defibrillation-proof applied parts
ECG Storage Internal storage up to 40 ECGs; optional expanded up to 200 ECGs
Weight 11.25 lbs. (5.1 kg) including battery (without paper)
Dimensions 15.5 x 17 x 4” (39.4 x 43.2 x 10.2 cm)
Power Requirements Universal AC power supply (100-240 VAC at 50/60 Hz) 110 VA; internal
rechargeable battery
9
SECTION 1
Accessories
Paper
Electrodes
10
SECTION 1
Acquisition Modules
Power Cords
Manuals
11
SECTION 1
12
EQUIPMENT PREPARATION
SECTION 2
Initial Startup
With its initial use, the device requires the user to set certain configurations prior to obtaining any ECGs. The
device will automatically display a language configuration page followed by AC filter frequency, height/weight
units, a set time/date configuration page (including daylight savings time selection), and a configuration page to pair
the WAM™ (wireless acquisition module) if it will be used. (Refer to the WAM user manual for detailed pairing
instructions to the device.)
Connect the AM12™ to the ECG connector at the rear of the device. When using the optional WAM for ECG
acquisition, the connector is not required.
Figure 2-1*
NOTE: The device must be configured at the factory for use with the WAM. Select F6 (More) followed by
F6 (More) to determine the device’s setting. “WAM Option Not Available” will display if the
device is not configured to work with the WAM.
13
SECTION 2
Loading Paper
Figure 2-2
1. Remove all packaging including cardboard backing from the paper stack.
2. Facing the front of the device, use the release latch on the left side and slide the paper tray cover to the left.
3. Place the stack of thermal paper into the paper tray such that the grid side of the paper is up when it is pulled
over the paper tray cover. The paper cue mark (a small black rectangle) should be in the lower left corner.
4. Manually advance one page of paper beyond the closure point of the writer. Make sure the paper lays on the
black roller evenly within the channel of the paper door. If paper is not manually advanced evenly, risk of
jamming or queue faults increases.
5. Slide paper tray cover to the right until the cover latches in a locked position. You will hear a sharp click when
the door is properly latched.
WARNING: Risk of injury to fingers in writer paper door or platen drive mechanisms.
NOTE: For proper printing performance, be certain to use Mortara recommended thermal paper.
14
SECTION 2
A4 Paper Users
Figure 2-3
1. Slide paper tray spacer towards rear wall of writer tray. Align the bottom four plastic arms with the four
openings in the base of the writer tray. Similarly, align the top 3 plastic arms with the three openings on the
rear wall of the writer tray.
15
SECTION 2
Figure 2-4
2. The paper tray spacer should be parallel with the rear wall of the writer tray.
Figure 2-5
5. Gently press on the top three plastic arms to remove the paper tray spacer.
16
SECTION 2
Applying Power
1. Plug the power cord into an AC wall outlet and into the back of the device. (Reference Figure 1-3.)
2. Press the power ON/OFF button located on the face panel of the device. (Reference Figure 1-5.)
When using AC power, the battery indicator is clear when charging and illuminates in white when fully charged.
When using battery power, the battery indicator illuminates in green with a 35% to 100% charge and in yellow with
a 20% to 35% charge. The battery indicator will turn to red when the battery charge is 20% or less.
The device should be connected to AC power for recharging when not in use.
NOTE: There are configurable features on the device that can be used to help prolong battery life (see
Section 4). Proper battery care and maintenance will also help prolong battery life.
CAUTION: The device can be operated on AC line voltage in the absence of a battery or in the
event of an otherwise fully depleted battery. When line voltage is removed the system immediately and
automatically continues on battery power. When the battery voltage is below 10.5V the device will
automatically power down. Once the battery voltage rises above 10.5V the device may be operated on
battery power. It may require up to 30 hours on AC line voltage to recharge the battery from its lowest
level. Routinely discharging a battery to the lowest level will severely shorten the life of the battery.
NOTE: When the On/Off button is depressed for longer than approximately 10 seconds, the
electrocardiograph will do a "hard reboot" and reset the internal clock to default date and time (1-1-2010)
and advise the user to “Set date/time.” When turned on, the user will need to re-enter the date and time.
This requirement may be bypassed if desired and an ECG can be acquired by selecting F6 (Exit) or
F5 (Save), but this ECG will have the date of 1-1-2010. With the next patient the electrocardiograph will
request the operator to enter the proper time and date again.
To prevent permanent damage to the internal lead-acid battery, the device will automatically power down when the
battery has been depleted to its lowest allowable level. When the device detects that the battery voltage has been
depleted to this level, it will display the messages “Battery Low – Charge Unit” for 10 seconds before shutting
down. Plugging in the AC cord during this time will cause the unit to return to the main acquisition screen.
If the device is in the ECG acquisition mode when the battery voltage is detected at its lowest allowable level, the
unit will display the message “Battery Low – Charge Unit”, but will not automatically shut down until the user exits
the ECG acquisition mode. This allows the user to complete an ECG already in progress.
17
SECTION 2
18
RECORD AN ECG
SECTION 3
Patient Preparation
Before attaching the electrodes, assure the patient fully understands the procedure and what to expect.
• Privacy is very important in assuring the patient is relaxed.
• Reassure the patient that the procedure is painless and that the electrodes on their skin are all that they
will feel.
• Make sure the patient is lying down and is comfortable. If the table is narrow, tuck the patient’s hands
under his/her buttocks to ensure their muscles are relaxed.
• Once all the electrodes are attached, ask the patient to lie still and to not talk. Explain this will assist you in
acquiring a good ECG.
Thorough skin preparation is very important. There is natural resistance on the skin surface from various sources
such as hair, oil, and dry, dead skin. Skin preparation is intended to minimize these effects and maximize the quality
of the ECG signal.
NOTE: With elderly or frail patients take care to not abrade the skin causing discomfort or bruising.
Clinical discretion should always be used in patient preparation.
Patient Hookup
A good minimum-impedance pathway will provide superior noise-free waveforms. Good quality silver-silver
chloride (Ag/AgCl) electrodes should be used.
TIP: Electrodes should be stored in an air-tight container. Electrodes will dry out if not stored properly
which will cause loss of adhesion and conductivity.
1. Expose the arms and legs of the patient to attach the limb leads.
2. Place the electrodes on flat, fleshy parts of the arms and legs.
3. If a limb site is not available, place the electrodes on a perfused area of the stump.
4. Attach the electrodes to the skin. A good test for firm electrode contact is to slightly tug on the electrode to
check adhesion. If the electrode moves freely, it needs to be changed. If the electrode does not move
easily, a good connection has been obtained.
19
SECTION 3
For accurate V-lead placement and monitoring, it is important to locate the 4th intercostal space. The 4th intercostal
space is determined by first locating the 1st intercostal space. Because patients vary with respect to body shape, it is
difficult to palpate the 1st intercostal space with accuracy. Thus, locate the 2nd intercostal space by first palpating the
little bony prominence called the Angle of Louis, where the body of the sternum joins the manubrium. This rise
in the sternum identifies where the second rib is attached, and the space just below it is the 2nd intercostal space.
Palpate and count down the chest until you locate the 4th intercostal space.
Midway between
V2/C2 and V4/C4
electrodes.
Green Green
Midway between
V4/C4 and V6/C6
electrodes.
Orange Black
White Red
Red Green
On the thigh or ankle.
Green Black
20
SECTION 3
Patient demographic information can be entered before acquisition. The entered patient ID fields will remain
populated until you acquire the ECG; however, if you disconnect the leads from the patient, turn off the
electrocardiograph, or change a configuration setting before acquisition, the patient information will be cleared.
To access the patient demographic data entry menu, press F1 (ID) from real-time ECG view. Use the appropriate
function key to select the desired study group. The patient demographic labels available are determined by the ID
format selected in the configuration settings. In addition to short or long patient ID formats, the device also supports
a custom ID format. The custom format, designed in ELI Link or an E-Scribe™ data management system, can be
downloaded to the device. Additional information about the custom ID can be found in Appendix A, or in the ELI
Link and E-Scribe user manuals.
Patient demographic entry can be completed manually or automatically using an existing patient record in the
directory. To manually enter the patient demographics, use Enter, Tab, F1 (▲), or F2 (▼) to move to each data
entry field. To enter gender, use F3 (►) to move through the options, or type F or M from the keyboard to change
the gender to female or male. The patient’s date of birth should be entered whenever possible to ensure
interpretation (if set in configuration settings) is as complete as possible.
NOTE: If no age is entered before acquiring an ECG, the interpretation will default to a 40-year old male.
The statement “INTERPRETATION BASED ON A DEFAULT AGE OF 40 YEARS” will be added to the
interpretation text.
NOTE: If an age of zero (0) is used, the interpretation will default to a 6-month old infant. The statement
“INTERPRETATION BASED ON A DEFAULT AGE OF 6 MONTHS” will be added to the interpretation
text.
NOTE: Where global measurement values are not available (i.e., rate, interval, axis), text such as ‘- -‘or
‘*’ or similar will display/print for the unavailable value.
NOTE: Where mandatory fields have been selected (i.e., Name, ID or Tech Initials), the required field will
be highlighted in red.
When done, select F6 (Done). Skipped fields will appear as a blank field on the header of the ECG printout.
To automatically populate the demographics using an existing patient record, select F5 (Dir) from the ID screen.
Use F1 (▼/▲) to navigate by line down the directory list; use (Shift), F1 (▼/▲) to move up. Similarly, use F2
(▼▼/▲▲) to page down the directory list; use (Shift), F2 (▼▼/▲▲) to page up. To quickly select a patient
name, use the keyboard to enter the first few letters of the last name. The letters will be displayed in the lower left
corner of the display screen and the desired name will automatically be highlighted. Once the desired name is
highlighted, press F3 (Selec) and the patient ID screen will return with all demographic fields populated. Return to
real-time ECG view by selecting F6 (Done).
TIP: Automatically populating demographic fields via the directory is only possible when the ID formats
are the same between records.
NOTE: A password may be required in order to enter the ECG directory. Obtain the password
from the department Administrator.
NOTE: A red ID label indicates there are no entries in the ID demographics, or a required field is
missing from the selected patient demographics.
21
SECTION 3
Entering Symbols
Punctuation characters, symbols, and/or accented alphanumeric characters (language dependent) can be entered
using the SYM key on the keyboard. Selecting SYM will display 10 special characters at a time. Use F1 (Prev) or
F2 (Next) to move to the previous/next set of special characters.
Each special character will have a numeric character located below it. Using the keyboard, press the desired
numeric key to add the corresponding special character. Select SYM or F6 (Done) to exit the symbol entry mode.
Auto-Fill ID
If Auto-Fill ID is enabled in the configuration, the system will automatically populate the demographic fields in the
ID screen. When the patient ID field is manually populated and followed either by selecting F6 (Done) or F2 (▼),
the system automatically scans the patient directory. If records with the exact patient ID are found, the existing data
is used to fill some of the demographic fields. The auto-fill feature is designed to automatically populate last name,
first name, date of birth, age, and gender only. If no matching records are found, a brief message is displayed and
the user must manually enter the patient’s demographics.
NOTE: In order to avoid the use of incorrect data, the auto-fill feature is only possible when the ID
formats are the same between records.
When time is of the essence or if patient demographics are not available, ID information can be added to the ECG
after it has been acquired via the patient directory. Acquiring an emergency (STAT) or unidentified ECG is
explained in ECG Acquisition, Printing, Storage.
Acquisition
Once the patient is connected, the device continuously collects and displays ECG data; therefore, before you press
ECG or RHY you should instruct the patient to relax in a supine position to ensure that the ECG is free from artifact
(noise) due to patient activity. If workflow permits patient demographic entry prior to acquisition, enter the patient
identification information as explained in Patient Demographics. After you complete the last data entry field, select
F6 (Done) to return to the real-time ECG view.
22
SECTION 3
NOTE: 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).
• WAM Low Battery – displays when a low battery signal for the WAM is detected.
• Searching for WAM – displays when the WAM is not detected. Occurs usually when the WAM is out of
range or not powered on.
When the problem is corrected, the device waits for 10 seconds of good data before analyzing the ECG. Please refer
to the following troubleshooting guide based on Einthoven’s Triangle:
Press the ECG key. The real-time ECG view is then replaced with the acquired ECG view. The default real-time
ECG view is not available in the acquired ECG view for navigation purposes.
NOTE: New LCD label functions are available in the acquired ECG view.
To acquire an emergency (STAT) or unidentified ECG for a new patient, press the ECG key two times. “Collecting
10 seconds of data” is displayed on the top of the LCD and “captured, analyzed, formatted” is displayed on the
bottom of the LCD. To save the captured ECG, select F1 (ID) to enter patient demographics. At the “New
Patient?” prompt, select “No”. The device will display the last patient record entered. (If “Yes”, is selected the
ECG will not be saved and the user will return to the real-time ECG view.) Use the existing information, enter new
demographics, or search the directory. Once completed, select F6 (Done). Select F3 (Print) to print or
F6 (Done) to exit. Choose to save or delete the ECG at the “Save ECG?” prompt.
The ELI 150c/250c incorporates a 5 minute memory buffer for collection of ECG data. When the Best 10 feature is
enabled, the device will automatically select the best 10 seconds of ECG from within the 5-minute buffer. The best
10 seconds is determined based upon measures of high and low-frequency noise found in the 10-second ECG
segments. Should a single limb lead or two precordial lead fail conditions occur, the Best 10 feature is disabled until
the limb lead fail or precordial lead fail condition is resolved. At resolution, the Best 10 feature becomes available
and the selection buffer continues.
Users can switch between BEST 10 or LAST 10 by selecting F5 (More) followed by F5 (Last) or F5 (Best)
depending on the current view.
23
SECTION 3
Printing
If Auto-Print is enabled in the configuration, an ECG is printed following acquisition. To print a manual printout,
select F3 (Print).
Toggle through the available waveform display formats (3, 8 or 12 lead) by selecting F2 (Leads). A preview of the
full 10-seconds of ECG waveform is available in the acquired ECG view. The first 5 seconds are shown on the
initial view screen (page 1/2 is displayed in the upper right corner); the second 5 seconds is viewed by selecting
F2 (Leads) again (page 2/2 is displayed in the upper right corner).
If the auto-print configuration is disabled, a 10-second preview will assist in ensuring a quality ECG acquisition
prior to printing. When you acquire an ECG, the electrocardiograph captures the last 10 seconds. The relationship
between the display and the printout is the same – what is displayed in the ECG acquisition view is what will be
printed.
In order to change the speed, gain, filter, or printout format in the acquired ECG view, select F5 (More). To
manipulate the print format of the acquired ECG regardless of the plot format configuration setting, select F4 (Fmt).
Select the function key corresponding to the desired print format. The acquired ECG view is then displayed and to
make an ECG printout copy in the new plot format, select F3 (Print). Select F6 (Done) to return to the real-time
ECG view.
Storage
NOTE: Users may delete an acquired ECG from the acquired ECG screen. Once the delete selection has
been made, a confirmation message will appear. Select Yes to permanently delete the record.
Begin routine rhythm strips by connecting the patient to the device and entering the patient identification
information. After the last data entry field from the ID menu is completed, select F6 (Done) to return to the real-
time ECG view. Select RHY to begin rhythm printing. You can also acquire a rhythm printout by selecting RHY
without entering the patient ID.
NOTE: Rhythm printouts are only possible from the real-time ECG view.
NOTE: Rhythm acquisitions are only printed and not stored in the device.
The rhythm activity screen appears as soon as the printer begins printing the rhythm strip. The waveform display
format is similar to the real-time ECG view; however, new function keys are available during rhythm printing.
In addition to manipulating Speed, Gain, and Filter, the user can toggle different lead groups: change lead groups
during printing by selecting F2 (Leads). The change in lead groups is apparent on the printout whereas the
waveform display will remain in the default display of 2.5 seconds of Leads I, II, and V1-V6.
24
SECTION 3
During 12-channel rhythm printing (ELI 250c only), the complete 12 leads are printed simultaneously.
During rhythm printing, place the printer in Standby mode by pressing F6 (Stby). To continue rhythm printing for
the same patient without advancing to a new page, select F6 (Cont). To stop the rhythm printing, press STOP and
the printer will automatically form feed in preparation for a new patient’s rhythm recording or ECG
25
SECTION 3
26
SYSTEM SETTINGS
SECTION 4
NOTE: The factory default password is “admin” (lowercase, no quotation marks); it is suggested that the
password be changed after installation of the unit.
Configuration Menus
The configuration pages define all operational conditions that do not change on a daily or patient-to-patient basis.
Once you set these default conditions, you will rarely need to use the configuration screens again. To access the
configuration menus:
• Use F4 (Page) to toggle through the configuration pages; use (SHIFT), F4 (Page) to toggle in reverse.
• Use F1 (▲) and F2 (▼) to move back and forth through each configuration option.
• Use F3 (►) to toggle through pre-programmed available settings per configuration field.
• Use F6 (Exit) to return to real-time ECG view. Any changes you have made will be saved.
• Use BKSP to erase entry errors.
To print the device’s configuration settings, select F6 (More) from real-time ECG view. Select F6 (More) again
followed by F1 (Print Configuration). The configuration printout captures every configuration setting: the
software version, the cart number of the device, and the date and time that the configuration printout occurred.
27
SECTION 4
28
SECTION 4
29
SECTION 4
WEP Key ID Alphanumerical field (26 digits) A-F, 0-9 (not on printout)
30
SECTION 4
Configuration Settings
Software Version
Cart Number
Site Number
Identifies the site of your device. Site numbers designate the hospital, clinic, or institution for ECG records stored in
an E-Scribe system and must be defined for transmitting and retrieving ECGs from that system. You can use up to
four digits for the site number. Numbers from 0 – 4095 are supported.
Site Name
Defines your clinic, hospital, or office name. You can enter up to 30 alphanumeric characters. The site name prints
at the bottom, left edge of the ECG printout.
Telephone Number
Specifies the telephone number for internal modem transmission to another unit or to an E-Scribe system. Enter up
to 45 numeric characters.
You may need to dial a 9 to get an outside line. To wait for an additional dial tone, use the letter W.
EXAMPLE: 9W14145554321
EXAMPLE: P14145554321
(If necessary, you can use both the letter W and the letter P in the same phone number.)
TIP: To quickly delete or modify a phone number, use a shortcut. From the application screen,
simultaneously press (SHIFT) + ALT + P. To edit an existing telephone number, use the Tab key.
Language
CAUTION: Function labels are immediately translated upon selecting a new language and exiting
the configuration screen.
31
SECTION 4
If an unknown language is visible, use the following steps to revert to the language of your country:
Alphabets of specific languages may require use of special characters in demographic fields. This is accomplished
by using the SYM key on the keyboard.
Volume
Defines the keyboard click loudness. Available settings range from 0 (off) to 8 (loud).
Determines when the electrocardiograph will switch off in order to conserve the battery life of the device. The
battery time out will only occur if the keyboard has not been depressed for the time specified. The battery time out
setting is ignored if an active ECG signal is detected during transmission or while rhythm printing.
ECG Storage
Indicates ECG storage capacity. Normal indicates standard memory capacity of 40 patient records. Expanded
indicates the optional expanded memory (200 patient records) has been installed.
ID Format
Defines the format for the patient demographic information prompts. There are two standard formats: short or long.
A custom ID format can be downloaded from ELI Link or an E-Scribe system. See Appendix A to download a
custom ID.
The short format includes the patient's last and first name, patient ID number, date of birth (automatically calculates
the age), and gender.
The long format is identical to the standard format except that it includes the patient's first name, room, and
comment fields.
Auto-Fill ID
When enabled, the device will automatically populate last name, first name, date of birth, age, and gender in the ID
screen if records with matching patient ID are found in the ECG directory.
32
SECTION 4
AC Filter
The device removes 60 Hz or 50 Hz interference. The setting you select depends on the line frequency in your
country. Always use the 60 Hz setting in the U.S. If AC interference is present, check to see that the proper AC
filter is selected.
Paper Speed
Configure to 25 mm/s or 50 mm/s for default ECG printouts. For rhythm printouts and display, speeds of 5 mm/s or
10 mm/s are also available. See Section 3 to change speeds for display or rhythm printing. Paper speed is printed at
the bottom right corner of the ECG printout.
Filter
The ECG plot-frequency filter (or print filter) can be set to 0.05 to 40 Hz, 0.05 to 150 Hz, or 0.05 to 300 Hz. The
plot-frequency filter does not filter the acquired digital record. A 40 Hz plot-filter setting will reduce the noise
(40 Hz and higher frequencies) on the printed ECG, and a 150 Hz plot-filter setting will reduce the noise (150 Hz
and higher frequencies) on the printout; a 300 Hz plot-filter setting will not filter the printed ECG. The filter setting
is printed at the bottom right corner of the ECG printout.
WARNING: 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.
Height Units
Weight Units
Defines the units of height (in/cm) and weight (lb/kg). Settings are selected independently of each other, allowing
for metric or U.S. forms of measurement to be used simultaneously or separately.
Interpretation
The device automatically analyzes ECGs and prints the optional interpretation on the ECG printout. This setting
allows you to select or suppress the “interpretive” text on the ECG report.
NOTE: The ECG interpretations 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.
Reasons
The reasons statements indicate why a particular interpretive statement was printed. Reasons statements print
enclosed in [square brackets] within the interpretive text if the interpretation option is turned on. Turning the
reasons statement function on or off does not affect the measurements performed or the interpretive statements
selected by the analysis program.
For Example:
Anteroseptal Infarct [40+ ms Q WAVE IN V1-V4]
Where “Anteroseptal Infarct” is the interpretive statement, and “40+ ms Q WAVE IN V1-V4” is the reason
statement or explanation as to why the interpretive statement was printed.
33
SECTION 4
Append
A status or statement phrase can be appended to the ECG and printed under the interpretive text printout. Either
“unconfirmed report” or “reviewed by” can be selected.
Number of Copies
Defines the number of printed copies when an ECG is taken. A zero (0) setting prints no ECG; one (1) prints the
original; two (2) prints the original plus 1 copy, and so on. Up to 9 copies may be selected.
Defines whether or not printed copies will include interpretation. The clinician may request the first ECG printout
with the interpretation included. Additional copies may be printed with or without the interpretation.
Delete Rule
Defines the rule to mark ECGs as deleted in the ECG directory. ECGs that are marked for deletion will be
automatically removed or erased based on their acquisition date (a first-in/first-out philosophy) to make room for the
new ECG record. ECGs are only erased from the directory when they are marked for deletion and if the directory
becomes full. More than one ECG may be removed from the directory in order to make room for the new incoming
record. The delete rule selections are:
Storage Resolution
Dictates the resolution of all stored ECG records. The resolution setting is either Normal or High. If the value is set
to High, the stored ECG will have a high resolution. As a result, the record size will be large and will reduce the
storage capacity in the ECG directory.
Determines whether a pacemaker spike(s) notification marker(s) will display at the base of the ECG printout.
ID Edit Disable
Selecting YES allows the ID to be edited at any time before the completion of the record or while still in the
acquired screen. Once the acquired screen has been left and the record is stored in the directory, the ID
demographics can no longer be edited at the electrocardiograph.
Caps Lock
Use A4 Paper
The ELI 250c accommodates use of Z-fold thermal paper in either letter size (8.5 x 11 inches; 216 x 279 mm) or A4
size (8.27 x 11.69 inches; 210 x 297 mm). The provided paper tray spacer is required for use with A4 size paper.
34
SECTION 4
Rhythm Formats
Defines the default values for rhythm printing. It is possible to set a 3 or 6-channel default rhythm format for the
ELI 150c. For the ELI 250c, a 3, 6, or 12-channel default rhythm format is possible. Define rhythm leads one
through three to customize a 3-channel rhythm printout or define rhythm leads one through six to customize the
6-channel rhythm printout.
Plot Format
Defines the default for one of the available plot formats in either standard or Cabrera presentation. Please note that
regardless of the plot format selected, 10 seconds of 12 leads are always stored.
35
SECTION 4
Rhythm Leads
Displays continuous rhythm of selected ECG leads and permits printing of selected leads. User may toggle between
selected leads, system set leads, or I, II, III, aVR, aVL, and aVF followed by V1, V2, V3, V4, V5, and V6.
Enabling this option will allow for the use of a Mortara approved USB bar code scanner.
Average RR
Enabling this option will display an averaged RR value to appear on the report.
QTcB
Enabling this option will display a Bazett’s corrected QT value on the report along with the default linear
QTc value.
QTcF
Enabling this option will display a Fridericia corrected QT value on the report along with the default linear
QTc value.
ECG Capture
Up to 5 minutes accumulated ECG data can be acquired internally for use with the Best 10 feature. The device
automatically selects the best 10 seconds from within the 5-minute buffer.
Users can switch between BEST 10 or LAST 10 by selecting F5 (More) followed by F5 (Last) or F5 (Best)
depending on the current view.
Encryption Key
Encryption Key is a sequence of numbers used to encrypt or decrypt data and can consist of up to 16 alpha/numeric
characters. All transmissions from x50c are sent using AES 256 bit encryption. The encryption key in the config
menu allows the user to set a custom pre-shared key between the cart and ELI Link version 4.00 or later (all carts
transmitting to one ELI Link must share the key) otherwise a default hidden key will be used.
Band Mode
Use 850/1900 MHz (US) or 900/1800 MHz (EU). (Applies to ELI 150c only.)
36
SECTION 4
DHCP
Defines whether the Dynamic Host Communication Protocol (DHCP) will be used to obtain an IP address. If DHCP
is Yes, the network will automatically and dynamically assign an IP address. If DHCP is No, you must enter the IP
address, def gateway, and sub net mask.
NOTE: All parameters related to network connection must be entered under the direction of the IT
Manager of the facility where the device is installed. See Appendix A for more information on device
connectivity settings.
NOTE: Network settings for LAN (first page of settings) and those for WLAN or GPRS (second page of
settings) are independent from each other.
IP Address
Enter the fixed IP address for network transmissions (if DHCP is not selected).
NOTE: An IP address will be required for both LAN and WLAN applications.
Def Gateway
Enter the address of the default gateway (if DHCP is not selected).
Host IP
NOTE: Addresses are always entered as 4 sets of 3 digits; therefore, an address of 192.168.0.7 must be
entered as 192.168.000.007.
Port Number
LAN MAC
Security (WEP)
Wired Equivalent Privacy (WEP) is an encrypted security protocol (part of the 802.11 standard). Access points can
have multiple WEP keys stored. Each one of them is identified by a number (e.g., 1, 2, 3, 4).
WEP Key
WEP Key ID
Enter the 128-bit WEP key ID value (26 digits in 13 sets of two digits).
37
SECTION 4
WLAN MAC
Shows the MAC address of the device’s wireless module for configuring access points.
SSID
Service Set Identifier (SSID) is the name of the wireless network. All ELI 150c electrocardiographs that will
transmit to the same network must have the same SSID name. This field is case sensitive.
WPA-PSK/WPA2-PSK
Allows for implementation of the “personal mode” of WPA. This mode of encryption employs Temporal Key
Integrity Protocol (TKIP) which dynamically changes keys as the system is used.
PSK Passphrase
The passphrase may be from eight to 63 ASCII characters or 64 hexadecimal digits (256 bits).
WPA-LEAP
Cisco® LEAP (Light Extensible Authorization Protocol) enables use of the device with wireless networks
employing the LEAP encryption protocol.
LEAP Password
WPA2-PEAP
Enables use of the device with wireless networks employing the PEAP encryption protocol.
PEAP Password
38
SECTION 4
Comm. Protocol
Select UNIPRO OR DICOM. DICOM is only available if the DICOM option has been installed.
NOTE: This parameter must be entered under the direction of the IT Manager of the facility where the
device is installed.
NOTE: Units ship by default with Comm. Protocol set to UNIPRO or DICOM. The UNIPRO or DICOM
setting is not supported by E-Scribe or ELI Link versions prior to V4.00. For questions about compatibility
of your device with ELI Link and UNIPRO or DICOM, contact Mortara Technical Support.
Sync Mode
Select None, XMT, or XMT+Orders (XMT+MWL if DICOM enabled). None requires a manual transmission of
reports and then a second manual request to receive orders from the cardiology management system. XMT will
automatically transmit the report; XMT+Orders will both transmit the report and retrieve the orders.
Sync Date/Time
Select Yes or No. Yes will synchronize the date/time with the approved cardiology management system. With No,
there will be no date/time synchronization. Date/time synchronization is done through ELI Link V4.00 or later.
Defines fields required for ECG transmission to the cardiology management system. None will allow data
transmission without limitation; Last Name requires the technician to enter a minimum of the Last Name; ID
requires the technician to enter a minimum of the patient’s ID; Tech ID requires the technician to enter a minimum
of the technician’s initials. You may also select each of these independently allowing for any multiple required
selections as well.
39
SECTION 4
40
ECG DIRECTORY
SECTION 5
The standard ECG directory saves up to 40 individual ECG records. The optional expanded memory permits up to
200 individual ECG records.
To access the ECG directory, select F6 (More) followed by F1 (Directory of Stored ECGs) from the real-time ECG
view.
NOTE: A password may be required in order to enter the ECG directory. Obtain the password from the
department Administrator.
NOTE: In the ECG directory list, “P” represents the record has been printed, “X” represents the record
has a delete status, and “T” represents the record has been transmitted.
Management of the ECG record is performed within the directory of stored ECGs. The desired record must be
highlighted in order to view, print, edit, add demographics, or to change delete status.
Use F1 (▼/▲) to navigate by line down the ECG directory; use (Shift), F1 (▼/▲) to move up. Similarly, use
F2 (▼▼/▲▲) to page down the ECG directory; use (Shift), F2 (▼▼/▲▲) to page up. To quickly select a
patient name, use the keyboard to enter the first few letters of the last name. The letters will be displayed in the
lower left corner of the display screen and the desired name will automatically be highlighted.
An ECG may be stored in the directory but have a “delete status” (indicated by “X”). The directory saves records
marked for deletion in the event that you may want to recover the ECG at a later time. Records are automatically
marked for deletion based on the delete rule configuration (see Section 4). To manually mark an ECG record for
deletion, highlight a name from the ECG directory and select F4 (Delet). An “X” will appear in the far right-hand
column of the directory. To remove the delete status, re-highlight the name and select F4 again. All stored ECGs
will remain in the directory until it becomes full. When necessary to store a newly acquired ECG, only those
records that have been marked for deletion will be removed.
To view a specific ECG record, highlight the desired name from the directory list and press F3 (Selec). The selected
ECG is presented in acquired ECG view. Toggle through the available waveform formats by selecting
F2 (Leads). To make an additional copy of the ECG, select F3 (Print). To view or change the patient
demographics, select F1 (ID). To return to the ECG directory, select F6 (Done).
In order to change the speed, gain, filter, or printout format in the acquired ECG view, select F5 (More). To
manipulate the print format of the acquired ECG regardless of the plot format configuration setting, select F4 (Fmt).
Select the desired plot format setting and return to the acquired ECG view.
The directory is easily sorted either by name, ID, or date. To sort the ECG records, select F5 (More) from the ECG
directory.
• Select F1 to sort the directory by patient name (patient ID and time/date are displayed in the top row)
• Select F2 to sort the directory by patient ID (patient name is displayed in the top row)
• Select F3 to sort the directory by acquisition date (patient name is displayed in the top row)
To make a printout of the ECG directory, select F4 (Print Directory). The directory lists stored ECGs based on
how you have the directory sorted. The printout indicates if the ECGs have been printed, marked delete, or
transmitted with an “X” in the appropriate column. Select F6 (Exit) to return to the ECG directory.
41
SECTION 5
To display the ECG order list, select F4 (Order) from the patient ID screen. The ECG order list is comparable to the
ECG directory in looks and in practice; you can sort the list by name, ID, or date. To sort the orders, first select F5
(More):
Select F1 to sort the orders by patient name (ID, time, and date are displayed in the top row)
Select F2 to sort the orders by patient ID (name is displayed in the top row)
Select F3 to sort the orders by acquisition date (name is displayed in the top row)
To make a printout of the orders list, select F4 (Print Orders). Select F6 (Exit) to return to the ECG order list.
NOTE: A password may be required in order to enter the ECG Order List. Obtain the password from the
department Administrator.
42
CONNECTIVITY AND ECG TRANSMISSION
APPENDIX A
ECG Transmission
You may transmit ECGs to ELI Link, or to a third party EMR using an optional factory installed internal modem,
LAN, WLAN, or optional integrated GPRS mobile connection (GPRS option applies to ELI 150c only): all the
mentioned transmission modes can use the Mortara UNIPRO or DICOM communication protocol.
NOTE: Units ship by default with Comm Protocol set to UNIPRO. The UNIPRO setting is not supported
by E-Scribe versions prior to V8.10 or ELI Link versions prior to V3.10. For questions about compatibility
of your device with E-Scribe or ELI Link and UNIPRO, contact Mortara Technical Support.
Before transmitting ECGs, certain configuration options must be set in system settings depending upon the
transmission media used and the electronic storage media you are transmitting to (see Section 4).
NOTE: In order to properly connect to telephone lines, the device’s internal modem needs to be set on the
proper country code. This is an internal setting and should not be confused with International calling
codes.
The WLAN performance of the device may vary due to changes in RF (radio frequency) properties at your site or to
environmental conditions. If you are experiencing intermittent connectivity in certain areas of your facility, it may
be necessary to re-initiate the transmission process. You can also consult your hospital IT department or your
Mortara Instrument technical service representative regarding modification of your WLAN to improve system
performance.
To transmit records, select SYNC. To stop transmissions, use the STOP key.
To transmit one ECG, select F2 (Select) to choose a record from the patient directory. Use F1 (▼/▲) to navigate
by line down the directory list; use (Shift), F1 (▼/▲) to move up. Similarly, use F2 (▼▼/▲▲) to page down
the directory list; use (Shift), F2 (▼▼/▲▲) to page up. To quickly select a patient name, use the keyboard to
enter the first few letters of the last name. The letters will be displayed in the lower left corner of the display screen
and the desired name will automatically be highlighted. When the desired record is highlighted, use F3 (Sync) to
transmit the individual ECG.
To batch transmit all records in the directory, select F1 (Batch). In a batch transmission, only those records which
have not been previously transmitted or marked for deletion will be transmitted. After the transmission of your
record(s), the real-time ECG view is displayed
43
APPENDIX A
Modem Transmission
For a modem transmission, set the Sync media to modem. Connect the device to a standard telephone jack with the
provided phone line cable. Plug the cable into the telephone jack located on the back of the device and the other end
into a telephone wall jack. Confirm telephone number in the configuration settings.
Modem Initialization
The modem initialization string is country specific. At the time of production, the modem initialization string is
configured for the country of manufacture; however, if the unit is relocated to a different country, the modem
initialization string will need to be modified.
44
APPENDIX A
45
APPENDIX A
46
APPENDIX A
47
APPENDIX A
LAN Transmission
For a LAN transmission, connect the ethernet cable to the LAN connection at the rear of the device and set the Sync
media to LAN in the configuration. It is necessary that the IT Manager of your facility set the device’s LAN
configuration values.
NOTE: Addresses are always entered as 4 sets of 3 digits; therefore, an address of 192.168.0.7 must be
entered on the device as 192.168.000.007.
CAUTION: Possible damage to the device may occur if telephone cable is connected to the LAN
connector.
At the external LAN interface connector, the user is presented with two LEDs (Light Emitting Diodes). The two
status indicator LEDs provide signals for “link status” and “packet transmit/receive”. As the external connector is
viewed from the outside rear of the device, the left LED remains illuminated when the network link is detected. The
right LED flashes when a transmit or receive packet occurs or any traffic on the network is detected.
If DHCP is set to NO, your LAN access point will have a static network setting and the following parameters must
be configured in the device:
IP Address
Default Gateway
Sub Net Mask
If DHCP is set to YES, your LAN access point will have an automatic network setting and IP address; default
gateway and sub net mask do not need to be configured. In either DHCP setting, the following network parameters
must be provided by your IT Manager:
Host IP
Port Number
NOTE: Addresses are always entered as 4 sets of 3 digits; therefore, an address of 192.168.0.7 must be
entered on the device as 192.168.000.007.
NOTE: All parameters related to network connection must be entered under the direction of the IT
Manager of the facility where the device is installed. See also Appendix A for more information on device
connectivity settings.
NOTE: Network settings for LAN (first page of settings) and those for WLAN or GPRS (second page of
settings) are independent from each other.
If WEP security is disabled on your access point, then set security (WEP) to NO. If WEP security is enabled on
your access point, the following wireless network parameters must be configured in the device by the IT Manager:
Security: WEP
WEP Key
WEP Key ID
NOTE: The range for the WEP key is 0-3. If the range on your access point is 1-4, then 0 at the device
maps to 1 on the access point; 1 maps to 2 on the access point, etc.
48
APPENDIX A
If your wireless security environment is WPA or WPA2 (Wi-fi Protected Access) then you will need to enter:
Security: WPA-PSK or WPA2-PSK
Passphrase:
If your wireless security environment is LEAP then you will need to enter:
Security: WPA-LEAP
LEAP User Name
LEAP Password
If your wireless security environment is PEAP then you will need to enter:
Security: WPA2-PEAP
PEAP User Name
PEAP Password
49
APPENDIX A
WLAN Transmission
For a WLAN transmission, set the Sync media to WLAN. It is necessary that the IT Manager of your facility
configure the wireless access point(s) and E-Scribe workstation. It is also required that your IT Manager provide the
device’s WLAN configuration values. The device can be configured for Dynamic Host Communication Protocol
(DHCP) or static IP. Wireless security encryption options include WEP, WPA, WPA2, LEAP, and PEAP.
NOTE: Environmental conditions may affect the reliability of WLAN transmissions.
NOTE: The location for antenna for GPRS and WLAN are interchangeable.
If DHCP is set to NO, your wireless access point will have a static network setting and the following parameters
must be configured in the device:
IP Address
Default Gateway
Sub Net Mask
If DHCP is set to YES, your wireless access point will have an automatic network setting and IP address; default
gateway and sub net mask do not need to be configured. In either DHCP setting, the following wireless network
parameters must be provided by your IT Manager:
Host IP
Port Number
SSID
Channel Number
NOTE: Addresses are always entered as 4 sets of 3 digits; therefore, an address of 192.168.0.7 must be
entered on the device as 192.168.000.007.
NOTE: All parameters related to network connection must be entered under the direction of the IT
Manager of the facility where the device is installed. See also Appendix A for more information on device
connectivity settings.
NOTE: Network settings for LAN (first page of settings) and those for WLAN or GPRS (second page of
settings) are independent from each other.
If WEP security is disabled on your access point, then set security (WEP) to NO. If WEP security is enabled on
your access point, the following wireless network parameters must be configured in the device by the IT Manager:
Security: WEP
WEP Key
WEP Key ID
NOTE: The range for the WEP key is 0-3. If the range on your access point is 1-4, then 0 at the device
maps to 1 on the access point; 1 maps to 2 on the access point, etc.
If your wireless security environment is WPA or WPA2 (Wi-fi Protected Access) then you will need to enter:
Security: WPA-PSK or WPA2-PSK
Passphrase:
50
APPENDIX A
If your wireless security environment is LEAP then you will need to enter:
Security: WPA-LEAP
LEAP User Name
LEAP Password
If your wireless security environment is PEAP then you will need to enter:
Security: WPA2-PEAP
PEAP User Name
PEAP Password
NOTE: When saving the WLAN configuration, the device may require several seconds to complete the
saving procedure.
51
APPENDIX A
CAUTION: GPRS mobile hookup time will vary depending on location. It may require between
5 and 60 seconds to initiate a communication link. Signal loss at the onset of transmission or during
transmission may occur due to environmental variables.
NOTE: The location for antenna for GPRS and WLAN are interchangeable.
GPRS option applies to ELI 150c only.
GSM (Global System for Mobile communications) is a world standard for digital cellular communications. GPRS
(General Packet Radio Service) is the digital data transmission standard for the GSM network. Similar to GSM
cellular phones, the ELI 150c GPRS mobile connectivity option requires a Subscriber Identity Module (SIM) smart
card. A SIM comprises a microcontroller, ROM for programs, and EPROM for information. Information stored on
the SIM includes the International Mobile Subscriber Identity (IMSI) which is a unique identifying number, plus
various network-specific user and security data.
SIM cards and data network plans are not offered for sale by Mortara Instrument and must be purchased separately
from your local provider. The ELI 150c GPRS mobile connectivity option is factory installed. Please note that for
GPRS mobile transmission, the SIM card must have data capabilities enabled.
For GPRS mobile transmission, set the Sync media to GPRS in the configuration.
The following wireless network parameters must be provided by the IT Manager of the facility where the receiving
station (e.g. E-scribe) is located:
Host IP
Port Number
NOTE: The receiving station’s IP-address must be visible on the public network (Internet).
The following parameters must be provided by the network service provider of the SIM card:
Access Point Name
Access Point User Name
Access Point Password
The Access Point Name (APN, also called WAP) is a string with structure “NetwordID.OperatorIdentifier”.
52
APPENDIX A
If a wireless network carrier is not detected at the time of transmission (due to environmental conditions, i.e., poor
signal), relocate or reposition the unit for a better signal and reattempt transmission.
In order to change a network carrier, you must scan the wireless network to determine what is detected and available
for use. Select F5 (Scan), a “scanning networks…” message will appear on the LCD. Once the scanning process
is completed, the Select Networks screen is available. Highlight the desired network and press F3 (Selec).
Orders Download
NOTE: A custom ID must be downloaded before downloading the orders. Please reference the ELI Link
user manuals, and Custom ID Download in this section.
The device can download and process an ECG order list from ELI Link or another compatible electronic information
management system.
Order lists containing the demographic information of patients requiring an ECG are designed in ELI Link or an
E-Scribe system. The technician at the device selects the desired order code (e.g., a code specific to a department or
floor) and the patients belonging to the order list. Once downloaded to the device, the ECG list for the selected
order code is stored in the device as the order list (similar to the ECG directory). As with ECG data transmission,
you can use any of the connectivity options to download the order list.
From real-time ECG view, select F6 (More) followed by F3 (Orders Download). Use the appropriate function
key to select the desired study group.
Use F1 (▲) and F2 (▼) to scroll through the list; use F3 (Selec) to select the desired order code. Confirm or deny
your download by selecting F2 or F4.
“Transmission Status” will be displayed for approximately 10 seconds followed by “Dialing: telephone number”,
“Waiting for Response”, and “Connected”. Once connected, the screen indicates the number of orders (ECGs)
received for the order code. This only appears briefly before returning to the real-time ECG view. When the order
list has been downloaded, you may select the patients who need ECGs. Select F1 (ID) from the real-time ECG
view.
Custom ID Download
Custom ID formats are uniquely defined by your facility’s needs. This customized ECG header information is
designed in ELI Link and downloaded to the device.
From real-time ECG view, select F6 (More) followed by F2 (Custom ID Download). “Transmission Status”
will remain visible for approximately 10 seconds followed by “Waiting for Response”, “Connected”, and “Custom
ID downloaded”. A return to the real-time ECG view indicates the custom ID download is complete. The custom
ID remains the new header format for all future ECGs until you select a different ID format in the configuration
settings. You may alter the ID format configuration to short, standard, long, or custom based on your patient
demographic entry needs. The custom ID is only deleted upon downloading a new custom ID or on the rare
occasion of downloading software – it will not be lost due to power loss or switching to a different ID format.
TIP: Upon custom ID download, the ID format will assume the group name as designed in ELI Link
or E-Scribe.
53
APPENDIX A
NOTE: The site number must be configured in the electrocardiograph and recognized as an established,
valid site number at the E-Scribe before downloading the custom ID.
TIP: Confirm the baud rate in the configuration settings before downloading the custom ID from ELI Link
or E-Scribe (applies to ELI 150c only).
USB Memory
Both the ELI 150c and ELI 250c come equipped with a standard USB host port which can be used to transmit
patient records from the device’s internal memory to an external USB memory stick. In addition, either device can
be equipped with an optional USBD (device) port. The optional USBD port can be used to directly connect the
device to a PC running ELI Link V3.10 or later.
NOTE: The USB memory stick must not contain any automatic features (e.g., Sandisk U3). Uninstall any
features from the memory stick before connecting it to the device.
NOTE: All communication options (MODEM, LAN, WLAN, GPRS) including time sync and orders
download are disabled when a USB memory stick is inserted in the device.
NOTE: Upon successful transmission the device display will state “Transmission status transmit
complete. Press any key to continue.” The total number of patient records transmitted to the USB
memory stick will also appear.
NOTE: Patient records transmitted to a USB memory stick are marked as transmitted by the device.
54
APPENDIX A
The optional USBD port permits transmission of stored patient records to a PC using a direct USB cable. The
patient records will be transmitted to an ELI Link application (requires V3.10 or later) and then exported and saved
in various formats (see the ELI Link user manual).
NOTE: Requires ELI Link V3.10 or later. See ELI Link user manual for further detail on settings.
NOTE: User must create an Input and Output folder for records to be stored or retrieved for use in
ELI Link.
NOTE: Patient records transmitted to ELI Link are not marked as transmitted by the device.
WARNING: Do not change or modify any information existing in any of the ELI 150c or ELI 250c
folders that are visible on the PC in the removable disk file.
CAUTION: To assure consistent operation and avoid confusion, connect only one ELI 150c or
ELI 250c using the USB device port to a PC at a time.
55
APPENDIX A
Network Test
Network test sends a command to the server to verify there is a network connection. The status will display for the
clinician to review. The test information is also placed into the Log File for review.
To view the log type select F6 (More) from the real-time display, followed by F4 (Network Test). When test is
completed, select either F3 (Log) to review the log files or F6 (Exit).
The ELI x50c will then present a sync log file that contains troubleshooting information and status information from
the previous SYNC operation. This file will have up to 3 sections (Time Sync, Transmit and Receive Requests),
based on the SYNC Mode and Time Sync configuration settings. The contents of this file will be retained for
viewing until the next SYNC or Network Test operation has been completed. The information available will contain
status information that is currently shown on the screen during the sync operation as well as more detailed
connection information and error codes.
56
MAINTENANCE AND TROUBLESHOOTING
APPENDIX B
57
APPENDIX B
58
APPENDIX B
To completely shutdown the device, disconnect the AC power cord then press the ON/OFF button. Such a
shutdown should always be performed prior to authorized repair of the device.
Test Operation
After cleaning and inspecting the device, proper operation of the unit may be confirmed by using an ECG simulator
to acquire and print a standard 12-lead ECG of known amplitude. Printing should be dark and even across the page.
There should be no evidence of print head dot failure (e.g., breaks in printing forming horizontal streaks). Paper
motion should be smooth and consistent during printing. Waveforms should appear normal with proper amplitude
and, without distortion or excessive noise. Paper should stop with perforations near the tear bar (indicating proper
cue sensor operation).
Following any service to the device or when non-compliant operation is suspected, Mortara Instrument, Inc.
recommends the following procedures:
Battery Maintenance
The device houses an internal, sealed lead-acid battery. When installed, the battery has a shelf life of approximately
six months without recharging. If the battery has been stored for a long period in a discharged state, it may not be
able to regain its capacity even if it is recharged.
For information about replacing the battery, please refer to the device’s service manual.
Mortara Instrument, Inc. recommends that the device be plugged into AC power whenever possible to maximize
battery life and for the user to develop a habit of recharging the battery before the unit indicates a “low battery”
condition. (That is, reduced depth of discharge.) Battery life varies by how the battery is maintained and how much
it is used. For improved battery life, keep the electrocardiograph plugged in when not in use.
The sealed lead-acid battery will provide optimum life when the unit is fully charged after each use. When the
battery charge is depleted to its lowest level (10.6V), the device will automatically power down. To recharge a
battery from its lowest level to 85%, 4 hours of recharging may be necessary. To reach 90%, 7 hours of recharging
may be necessary. It may take longer to reach 100%. The device can be used with AC power while simultaneously
charging.
59