ELI 150 User Manual Rev A1

Copyright© 2005 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. ELI 150 is a trademark of Mortara Instrument, Inc.

TECHNICAL SUPPORT AND SERVICE

Headquarters Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 Tel: 414.354.1600 Tel: 800.231.7437 Fax: 414.354.4760 Internet: http://www.mortara.com

Europe Economic Community Representative Mortara Rangoni Europe, Srl (European Headquarters, Italy) Via Oradour 7 40016 S. Giorgio di Piano, BO Tel: +39.051.6654311 Fax: +39.051.6651012

Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 Tel: 414.354.1600 Service: 888.MORTARA (888.667.8272) Fax: 414.354.4760 E-mail: [email protected]

Sales Support/ Supplies & Accessories Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 Tel: 414.354.1600 Fax: 414.354.4760 E-mail: [email protected] Mortara Instrument GmbH (Germany) Kaninenberghöhe 50 45136 Essen Tel: +49.201.268311 Fax: +49.201.268313 Mortara Instrument B.V. (The Netherlands) H. Dunantplein 6 3731 CL De Bilt Postbus 131 3720 AC Bilthoven Tel: +31.30.2205050 Fax: +31.30.2201531

24 Hour Technical Support Same Day Shipment of Replacement Parts Biomedical Training Classes Extended Warranties/Service Contracts

i

NOTICES

Manufacturer’s Responsibility Mortara Instrument, Inc., is responsible for the effects on safety and performance only if: • Assembly operations, extensions, readjustments, modifications or repairs are carried out only by persons authorized by Mortara Instrument, Inc. • The device (ELI 150) is used in accordance with the instructions for use. Responsibility of the Customer The user of this product is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do so may cause undue failure and possible health hazards. Equipment Identification Mortara Instrument, Inc. equipment is identified by a serial and reference number on the back of the device. Care should be taken so that these numbers are not defaced. Copyright and Trademark Notices This document contains information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced or translated to another language without prior written consent of Mortara Instrument, Inc. Other Important Information The information in this document is subject to change without notice. Mortara Instrument, Inc. makes no warranty of any kind with regard to this material including, but not limited to, implied warranties of merchantability and fitness for a particular purpose. Mortara Instrument, Inc. assumes no responsibility for any errors or omissions that may appear in this document. Mortara Instrument Inc. makes no commitment to update or to keep current the information contained in this document.

ii

WARRANTY INFORMATION

Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara products (hereinafter referred to as “Products”) shall be free from defects in material and workmanship under normal use, service and maintenance for the warranty period of such Product from Mortara or an authorized distributor or representative of Mortara. Normal use, service and maintenance means operation and maintenance in accordance with appropriate instructions and/or information guides. This Warranty does not apply to damage to the Products caused by any or all of the following circumstances or conditions: a) Freight damage; b) Parts and/or accessories of the Products not obtained from or approved by Mortara; c) Misapplication, misuse, abuse and failure to follow the Product instruction sheets and/or information guides; d) Accident, a disaster affecting the Products; e) Alterations or modifications to the Products not authorized by Mortara; f) Other events outside of Mortara’s reasonable control or not arising under normal operating conditions. THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCTS 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 Products (i) of all carrier charges with respect to any Products 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, 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 Products. 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 when sold. EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH AS PAPER, BATTERIES, ELECTRODES, PATIENT CABLES, LEAD WIRES AND MAGNETIC STORAGE MEDIUMS. EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE PRODUCTS FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCTS 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 MERCHANT ABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

iii

USER SAFETY INFORMATION

Warning

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

Caution

Means there is the possibility of damage to the equipment.

Note

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

Federal law restricts this device for sale to or on the order of a physician. Warning(s)

• Device (electrocardiograph, Class I) 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. • To ensure that electrical safety is maintained during operation from AC (~) power, the device must be plugged into a Hospital Grade outlet. • To maintain designed operator and patient safety, peripheral equipment and accessories used that can come in direct patient contact, must be in compliance with UL 60601-1, IEC 60601-1 and IEC 60601-2-25. • Patient cables intended for use with the ELI 150 include series resistance (9 Kohm minimum) in each lead for defibrillation protection. Patient cables should be checked for cracks or breakage prior to use. • Conductive parts of the patient cable, electrodes and associated connections of Type CF applied parts, including the neutral conductor of the patient cable and electrode should not come into contact with other conductive parts, including earth ground. • To maintain designed operator and patient safety, only use parts and accessories supplied with the device and available through Mortara Instrument, Inc. • ECG electrodes could cause skin irritation and should be examined for signs of irritation or inflammation. • To prevent possible infection, single use components (e.g., electrodes) should be limited to one-time use only. • 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. • To ensure the safety of both the patient and the device, 1.5 meters (5 feet) of open area should surround the patient. • A possible explosion hazard exists; do not use the device in the presence of flammable anesthetics. • Before attempting to use the device for clinical applications the operator must read and understand the contents of the manual and any documents accompanying the device. iv

User Safety Information (Continued)

• Where the integrity of external protective earth conductor arrangement is in doubt, the ELI 150 shall be operated from its internal electrical power source. • All signal input and output (I/O) connectors are intended for connection of only devices complying with IEC 60601-1, or other IEC standards (e.g. IEC 60950), as appropriate to the device. Connecting additional devices to the ELI 150 may increase chassis and/or patient leakage currents. To maintain operator and patient safety, consideration should be given to the requirements of IEC 60601-1-1, and leakage currents should be measured to confirm no electric shock hazard exists. • To maintain immunity to potential interfering electromagnetic signals, shielded cabling must be used when connecting the ELI 150 to a network. • To maintain operator and patient safety, equipment connected to the same network as the ELI 150 must meet the requirements of IEC 60950 or IEC 60601-1. • To prevent electric shock due to unequal ground potentials that may exist between points of a distributed network system, or fault conditions in external network connected equipment, network cable shielding must be connected to protective earth ground appropriate to the area where the ELI 150 is used. • The ELI 150 has not been designed for use with high-frequency (HF) surgical equipment and does not provide a protective means against hazards to the patient. • The quality of the signal produced by the electrocardiograph may be adversely affected by the use of other medical equipment, including but not limited to defibrillators and ultrasound machines. • Do not connect telephone cable to LAN connector. • This equipment may contain a GSM (cellular modem) module for transmitting ECG records. Device labeling and the presence of an antenna port will indicate if your unit is equipped with the GSM module. If so equipped, the following notices apply: • The GSM module operates in allocated frequency bands depending on the model. Identification of the installed GSM module, when applicable, can be found on a label on the bottom of the ELI 150. • MultiTech Systems, Inc. Model MTSMC-G-F1 (Europe and elsewhere): 900/1800 MHz • MultiTech Systems, Inc. Model MTSMC-G-F2 (US and elsewhere): 850/1900 MHz • Use of the GSM module may interfere with other equipment operating in the vicinity. Check with local authorities or spectrum management officials in your facility to determine if restrictions apply to the use of this feature in your area. • Do not transmit via the GSM module with a missing or damaged antenna. Replace a damaged antenna immediately. • Use only the antenna supplied for use with this equipment. Unauthorized antennas, modifications, or attachments could damage the GSM module and may contravene local RF emission regulations or invalidate type approval.

v

User Safety Information (Continued)

• To ensure that the unit complies 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 unit's antenna and the body of the user and any nearby persons at all times. • The GSM module complies with all applicable RF safety standards including standards and recommendations for the protection of public exposure to RF electromagnetic energy that have been established by governmental bodies and other qualified organizations, such as the following: • Federal Communications Commission (FCC) • Directives of the European Community • Directorate General V in Matters of Radio Frequency Electromagnetic Energy

Caution(s)

• To prevent possible damage to the keypad, 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. • No user serviceable parts inside. Screw removal by qualified service personnel only. • 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.

vi

User Safety Information (Continued)

Notes

• Excessive patient movement could interfere with the operation of the device. • Proper patient preparation is important to proper application of ECG electrodes and operation of the device. • There is no known safety hazard if other equipment, such as pacemakers or other stimulators, are used simultaneously with the ELI 150; however, disturbance to the signal may occur. • If the ECG amplifier input is out of normal operating range, the display will indicate a lead fail for the lead(s) where this 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 applied parts • Ordinary equipment • Not suitable for use in the presence of flammable anesthetics • Continuous operation NOTE: From a safety perspective, per IEC 60601-1 and derivative standards / norms, this unit 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 unit. Exposed metal accessible during normal operation is double insulated from mains. Internal connections to earth ground are functional earth. • The ELI 150 will automatically turn off (blank screen) if the batteries have been severely discharged and the AC mains is disconnected from the unit. • After operating the ELI 150 using battery power, always reconnect the power cord. This ensures that the batteries will be automatically recharged for the next time you use the ELI 150. A light will illuminate, next to the on/off switch, indicating that the unit is charging. This light will turn off when the battery is fully charged. • The ELI 150 is a UL Classified Device: WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL2601-1, IEC60601-1, CAN/CSA CC22.2 No. 601.1, AND IEC60601-2-25 5P35

vii

EQUIPMENT SYMBOLS AND MARKINGS

Symbol Delineation Attention, consult accompanying documents

Alternating current

Protective earth (ground)

Fuse

Telephone line (modem)

Network (LAN)

Defibrillator-proof type CF applied part

Output/Transmit

Input

ON/OFF (power)

Stop (of action)

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Equipment Symbols and Markings (Continued)

Shift key (to enter upper case text)

Space key

Enter key (accept data/return)

Initiate printing of 12-Lead ECG

Initiate printing of continuous rhythm strip

Do not dispose as unsorted municipal waste. Per EC Directive 2002/96, requires separate handling for waste disposal according to national requirements

Antenna

Indicates compliance to applicable EEC directives

ix

Equipment Symbols and Markings (Continued)

x

ELECTROMAGNETIC COMPATIBILITY (EMC)

Electromagnetic compatibility with surrounding devices should be assessed when using the system. An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic compatibility (EMC) has been performed on the ELI 150 cardiograph 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 system should not be used adjacent to, or stacked on top of other equipment. If the system must be used adjacent to or stacked on top of other equipment, verify that the system operates in an acceptable manner in the configuration in which it will be used. Fixed, portable, and mobile radio frequency communications equipment can affect the performance of medical equipment. See Table X-4 for recommended separation distances between the radio equipment and the system. The use of accessories and cables other than those specified below, may result in increased emissions or decreased immunity of the system. 9293-032-50 9293-032-51 9293-033-50 9293-033-51 9281-002-50 3181-008 3181-002

ELI 150 Patient cable, 12 channel, 10 leadwires banana plug - AHA ELI 150 Patient cable, 12 channel, 10 leadwires banana plug - IEC ELI 150 Patient cable, 12 channel, 10 leadwires snap - AHA ELI 150 Patient cable, 12 channel, 10 leadwires snap - IEC COLORS Banana plug to snap leadwire, 4mm, set of 10 Power cord, hospital grade, 8’ US Power cord, hospital grade, 8’ INTERNATIONAL

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ELECTROMAGNETIC COMPATIBILITY (EMC) (Continued)

Table X-1 Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The system is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the system should assure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment: Guidance

RF Emissions CISPR 11

Group 1

The system uses RF energy only for its internal function. Therefore, its RF emissions are very low and not likely to cause any interference in nearby electronic equipment.

RF Emissions CISPR 11

Class A

Harmonic Emissions IEC 61000-3-2

Complies

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

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

Table X-2 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that it is used in such an environment. Emissions Test

Compliance

Compliance Level

Electromagnetic Environment: Guidance

Electrostatic Discharge (ESD) IEC 61000-4-2

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

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

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

Electrical Fast transient/burst IEC 61000-4-4

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

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

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

Surge IEC 61000-4-5

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

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

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

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

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

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

Mains power quality should be that of a typical commercial or hospital environment. If the user of the system requires continued operation during power mains interruptions, it is recommended that the system be powered from an uninterruptible power supply or a battery.

Power frequency (50./60 Hz) magnetic field

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

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ELECTROMAGNETIC COMPATIBILITY (EMC) (Continued)

Table X-3 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that they are used in such an environment. Emissions Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment: Guidance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Radiated RF IEC 61000-4-3

3 Vrms 80 MHz to 2.5 GHz

3 Vrms 80 MHz to 2.5 GHz

80 MHz to 800 MHz 80 MHz to 800 MHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

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 system is used exceeds the applicable RF compliance level above, the system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the system. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.

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ELECTROMAGNETIC COMPATIBILITY (EMC) (Continued)

Table X-4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the ELI 150 cardiograph. The system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the system can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system as recommended below, according to the maximum output power of the communications equipment. Rated Maximum Output Power of Transmitter W

Separation Distance According to Frequency of Transmitter (m) 150 KHz to 800 MHz

800 MHz to 2.5 GHz

0.01

0.1 m

0.2 m

0.1

0.4 m

0.7 m

1

1.2 m

2.3 m

10

4.0 m

7.0 m

100

12.0 m

23.0 m

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where 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.

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TABLE OF CONTENTS

INTRODUCTION SECTION 1 Manual Purpose... 1-1 Audience... 1-1 Indications for Use... 1-1 Conventions Used in the User’s Manual... 1-1 Chapter Purpose... 1-1 System Description... 1-2 Figure 1-1, System Illustration... 1-2 System Layout... 1-3 Figure 1-2, ELI 150 Left Side... 1-3 Figure 1-3, ELI 150 Rear... 1-3 Figure 1-4, ELI 150 Base... 1-4 Figure 1-5, ELI 150 Display and Keyboard... 1-5 Automatic Feature Keys... 1-5 ELI 150 Specifications... 1-6

GETTING STARTED SECTION 2 Chapter Purpose... 2-1 Equipment Set-Up... 2-1 Load Paper... 2-1 Apply Power... 2-2 Set Time/Date... 2-2 Patient Preparation... 2-4 Patient Hookup... 2-4 Real Time ECG View... 2-5

SYSTEM SETTINGS SECTION 3 Chapter Purpose... 3-1 Access Configuration Menus... 3-1 Summary of Configuration Menus... 3-3 Configuration Page 1... 3-5 Configuration Page 2... 3-7 Configuration Page 3... 3-10 Configuration Page 4... 3-12 Configuration Page 5... 3-13 Configuration Page 6... 3-14

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Table of Contents (Continued)

RECORD AN ECG SECTION 4 Chapter Purpose... 4-1 Display Overview... 4-1 Patient Demographics... 4-3 ECG Acquisition, Printing, Storage... 4-5 Acquisition... 4-5 Printing... 4-6 Storage... 4-8 Acquiring Rhythm Strips... 4-8 Optional Barcode Scanner... 4-10

SPECIAL FUNCTIONS SECTION 5 Chapter Purpose... 5-1 Application Menu... 5-1 Patient Directory... 5-2 Print Configuration... 5-5 Set Time/Date and LCD Contrast... 5-5

ELI 150 CONNECTIVITY APPENDIX A Chapter Purpose... A-1 Transmitting Records... A-1 Direct Connection... A-3 Modem Transmission... A-3 Internal Modem Initialization... A-3 Internal Modem Country Code List... A-4 External Modem Initialization... A-5 External Mode Country Code list... A-5 LAN Transmission... A-8 GSM Transmission... A-9 Receive ECGs... A-11 Retrieve ECGs... A-12 Requests Download... A-13 Patient Request List... A-16 Custom ID Download... A-18

MAINTENANCE AND TROUBLESHOOTING APPENDIX B Troubleshooting Chart... B-1 Inspection and Cleaning... B-2 Test Operation... B-2 Recommendations to Biomedical Staff... B-3 Cleaning the Patient Cable... B-3 Battery Maintenance... B-3

GLOSSARY xvi

INTRODUCTION SECTION 1

Manual Purpose This Operator's Manual explains how to operate the ELI 150 electrocardiograph. This manual describes how to perform the following tasks: • Preparing the cardiograph for use • Using and understanding the keyboard, the viewing screen, and the menu sequences • View, Acquire, Print and Store ECGs • Connectivity and Transmitting ECGs (Appendix A) • Troubleshooting and maintaining the cardiograph (Appendix B)

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

Indications for Use The ELI 150 is indicated for use in a clinical setting, by qualified medical professionals only for recording ECG data of patients. • The device is indicated for use to acquire, analyze, display and print ECG data for consideration by physicians. • The device in 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 data by the device are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data. • The device is indicated for use on adult populations, typically symptomatic. • The device is not intended to be used as a vital signs physiological monitor.

Conventions Used in the User’s Manual The ELI 150 user interface incorporates various function keys with variable labels as displayed on the LCD screen of the unit. These temporary key labels or “softkey” labels will be referred to in this manual in bold Arial font (e.g., Leads). In addition, dedicated keys such as the unit’s automatic feature keys will also appear in bold Arial font (e.g., AUTO 12, RHY, XMT, STOP). Other conventions, such as notes or tips will appear indented and italicized text. NOTE: Notes contain additional information on usage. TIP: Tips contain shortcuts or helpful hints.

Chapter Purpose This chapter is intended to provide the user with: • System description • Layout overview with graphical presentations • System specifications

1-1

SECTION 1

System Description The ELI 150 is a 12-lead diagnostic electrocardiograph capable of viewing, acquiring, printing, and storing ECG data. The ELI 150 is optionally equipped with Mortara’s VERITAS 12-lead resting interpretation algorithm. If this option is enabled, the VERITAS ECG 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 Mortara VERITAS resting interpretation algorithm, please refer to the Physician’s Guide to ECG Interpretation. Print formats supported include: 3, 3+1 or 3+3 channels in automatic mode and three or six channels during rhythm recording. The ELI 150 can operate on battery or line power. The ELI 150 electrocardiograph includes: • Patient Cable • Hospital Grade Power Cord • 1 pack paper • User’s Manual • Optional Accessory Starter Kit

ELI 150, System Illustration Figure 1-1

1-2