REF 9515-175-50-ENG Rev D1 ELI 230 12-LEAD RESTING ELECTROCARDIOGRAPH USER MANUAL Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A. CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Copyright © 2011 by Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, Wisconsin 53224 This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. AM12, ELI, VERITAS, and WAM are trademarks of Mortara Instrument, Inc. V1.10.
TECHNICAL SUPPORT AND SERVICE Headquarters Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Tel: 800.231.7437 Fax: 414.354.4760 Internet: http://www.mortara.com European Union Representative Mortara Rangoni Europe, Srl (European Headquarters) Via Cimarosa 103/105 40033 Casalecchio di Reno (BO) Italy Tel: +39.051.298.7811 Fax: +39.051.613.3582 Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.
NOTICES Manufacturer’s Responsibility Mortara Instrument, Inc. is responsible for the effects on safety and performance only if: • Assembly operations, extensions, readjustments, modifications, or repairs are carried out only by persons authorized by Mortara Instrument, Inc. • The device is used in accordance with the instructions for use. Responsibility of the Customer The user of this device is responsible for ensuring the implementation of a satisfactory maintenance schedule.
WARRANTY INFORMATION Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara products (hereinafter referred to as “Product/s”) shall be free from defects in material and workmanship under normal use, service, and maintenance for the warranty period of such Product/s from Mortara or an authorized distributor or representative of Mortara. The warranty period is defined as twenty-four (24) months following the date of shipment from Mortara.
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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 device. Note: Provides information to further assist in the use of the device. Warning(s) • This manual gives important information about the use and safety of this device.
USER SAFETY INFORMATION • To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes) must not be reused. To maintain safety and effectiveness, electrodes must not be used beyond their expiration date. • To ensure the safety of both the patient and the device, 1.5 meters (5’) of open area should surround the patient. • A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture.
USER SAFETY INFORMATION Note(s) • Patient movements may generate excessive noise that may affect the quality of the ECG traces and the proper analysis performed by the device. • Proper patient preparation is important to proper application of ECG electrodes and operation of the device. • 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.
USER SAFETY INFORMATION • The power supply cord and appliance inlet serve as the means to disconnect the unit from the mains power supply. To remove mains power from the unit, disconnect the power supply cord from the appliance inlet. • The device is UL classified: WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL2601-1, IEC60601-1, CAN/CSA CC22.2 No. 601.
EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation Attention, consult accompanying documents Alternating current Protective earth Defibrillator-proof type CF applied part ON/OFF (power) Do not dispose as unsorted municipal waste.
GENERAL CARE Precautions • • • Turn off the device before inspecting or cleaning. Do not immerse the device in water. Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents which may damage equipment surfaces. Inspection Inspect your equipment daily prior to operation. If you notice anything that requires repair, contact an authorized service person to make the repairs. • Verify that all cords and connectors are securely seated.
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).
ELECTROMAGNETIC COMPATIBILITY (EMC) Table X-1 Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment: Guidance RF Emissions CISPR 11 Group 2 The equipment must emit electromagnetic energy in order to perform its intended function.
ELECTROMAGNETIC COMPATIBILITY (EMC) Table X-3 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment.
ELECTROMAGNETIC COMPATIBILITY (EMC) Table X-4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Equipment The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.
TABLE OF CONTENTS INTRODUCTION SECTION 1 Manual Purpose ............................................................................................................................................................. 1 Audience ........................................................................................................................................................................ 1 Indications for Use ................................................................................................
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INTRODUCTION SECTION 1 Manual Purpose This manual is intended to provide the user with information about: • Using and understanding the ELI™ 230 electrocardiograph, the function keys, and the display screen. • Preparing the ELI 230 for use. (Section 2) • Acquiring, printing, and storing an ECG. (Section 3) • System settings. (Section 4) • Maintenance and troubleshooting. (Appendix A) Audience This manual is written for clinical professionals.
SECTION 1 System Description The ELI 230 is a 12-lead diagnostic electrocardiograph used for acquiring, viewing, and printing of 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.
SECTION 1 ELI 230, System Illustration Figure 1-1 3
SECTION 1 ELI 230, Left Side Figure 1-2 ELI 230, Rear Figure 1-3 4
SECTION 1 ELI 230, Base Figure 1-4 5
SECTION 1 ELI 230, Display Overview Figure 1-5 Heart Rate Speed Best 10 Gain Filter Clock Function Key Labels Function Keys Function Keys Function keys activate the liquid crystal display (LCD) label above each function key. LCD labels/functions change depending upon the screen displayed. If the label is blank, the function key is not active.
SECTION 1 The ELI 230 features a ¼ VGA 320 x 240 pixel LCD color display for valuable preview of ECG waveform, function key labels, and other parameters as explained below: Heart Rate (HR): 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. NOTE: If a lead fail occurs, a yellow indicator flashes in the middle of the display signifying which lead has the problem.
SECTION 1 Specifications 8 Feature Specification 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 320 x 240 LCD color display 4+4 or 6+6 lead presentation Input Impedance Input Dynamic Range Electrode Offset Tolerance Common Mode Rejection Meets or exceeds the requirements of ANSI/AAMI EC11 Patient Leakage Current Chassis Leakage Current
SECTION 1 Accessories Part Numbers Description 9100-029-50 PAPER CASE ELI 230 ROLL W/ HEADER 210mm 9293-048-50 AM12 PATIENT CABLE ASSEMBLY 30012-019-50 WIRELESS ACQUISITION MODULE (WAM) 9300-036 ELECTRODES RESTING 24mm SUCTION PK/6 9300-037 ELECTRODE RESTING CLAMP IEC PK/4 IEC 9325-001-50 ELECTRODE CLIP 4mm SET OF 10 9515-175-50-CD ELI 230 USER MANUALS 9516-175-50-ENG ELI 230 SERVICE MANUAL 9515-001-51-ENG PHYSICIAN'S GUIDE ADULT & PEDIATRIC UM Contact your dealer or go to www.mortara.
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EQUIPMENT PREPARATION SECTION 2 Connecting the Acquisition Module Connect the AM12™ to the USB port on the front end of the device. The ELI 230 will automatically convert to the AM12 acquisition module. When using the WAM™ (wireless acquisition module) for ECG acquisition, the connector is not required. Refer to the WAM user manual for pairing instructions to the ELI 230. Figure 2-1 USB port NOTE: The ELI 230 must be configured at the factory for use with the WAM.
SECTION 2 Loading Paper Figure 2-2 1. Remove the outer packaging from the paper roll. 2. Facing the front of the device, use the release latch on the top side to pull the paper tray cover slightly to the right and lift up to open. Note: cover does not come completely off. Remove any empty paper rolls. 3. Place the roll of thermal paper into the paper tray such that the grid side of the paper is up and paper roll edge faces to the left. 4.
SECTION 2 Applying Power 1. Plug the power cord into an AC wall outlet and into the back of the ELI 230. (Reference Figure 1-3.) Device powers on automatically and cannot be turned off when AC is connected (device can be put into standby mode). 2. If using battery power, press the power ON/OFF button (Reference Figure 1-5.) located on the face panel of the device.
SECTION 2 Setting Date and Time 1. Select MORE from real-time ECG view. 2. Select CONFIG. 3. Select 3 Set Time/Date. 4. The preprogrammed date and time is displayed. To make changes to the date and time values (using a 24hour clock) in the same format as displayed, use ▲ and ▼ to move back and forth through each row. 5. Use ► to select the year, month, day, hour, or minute. 6. Use +10 or -10 along with +1 or -1 to advance year, month, day, hour, or minute. 7. Select DONE to save changes. 8.
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.
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 Lewis, where the body of the sternum joins the manubrium.
SECTION 3 Patient Demographic Entry Patient demographic information can be entered before acquisition only if the patient is connected to the ELI 230. 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.
SECTION 3 Examine the display for any of the following notification messages: • • • Leads Off –displays when patient is not connected. Lead Fault –displays faulty lead(s). Re-prep and replace electrode(s) if necessary to obtain satisfactory waveform(s). (See Patient Preparation.) Electrode Wrong Position – displays one of the following when a lead is connected incorrectly or is in the wrong location. (See Patient Preparation.
SECTION 3 Best 10 Seconds Selection The ELI 230 incorporates a one-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 one-minute buffer. The best 10 seconds is determined based upon measures of high and low-frequency noise found in the 10-second ECG segments.
SECTION 3 Acquiring Rhythm Strips Rhythm strips are printed in the format defined in the configuration (3, 6, or 12 channel). See Section 4 for instructions to configure rhythm leads. Begin routine rhythm strips by connecting the patient to the ELI 230 and entering the patient data. Once completed, select 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 data.
SECTION 3 Transfer to a USB Memory Stick The user can transfer all the ECG records from the ELI 230 to an external USB memory stick at any time. Using a PC, create a directory on the USB memory stick called “Records.” When done, plug the USB memory stick into the USB port on the ELI 230 (same port as used for the AM12 acquisition module). Once the USB memory stick is connected, the device will automatically start transferring all existing records to the USB memory stick.
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SYSTEM SETTINGS SECTION 4 Accessing 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: 1. Select MORE from real-time ECG view. 2. Select CONFIG. 3. Select 1 to print the configuration settings. 4. Select 2 to enter the Modify Configuration menu. 5.
SECTION 4 The following chart summarizes the configuration parameters and the available options for each field.
SECTION 4 Configuration Settings Software Version Identifies the software version of your electrocardiograph. Language There are several languages available on the ELI 230 electrocardiograph. CAUTION: Function labels are immediately translated upon selecting a new language and exiting the configuration menu. If an unknown language is visible, use the following steps to revert to the language of your country: 1. 2. 3. 4. 5. 6. 7. From real-time ECG view, select MORE. Select CONFIG.
SECTION 4 Paper Speed Configure to 25 mm/s or 50 mm/s for default ECG printouts. Rhythm Paper Speed Configure to 5 mm/s, 10 mm/s, 25 mm/s, or 50 mm/s. Interpretation Option The ELI 230 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 printout.
SECTION 4 Plot Format Defines the default for one of the available plot formats in either standard or Cabrera presentation. Regardless of the plot format selected, 10 seconds of 12 leads are always stored. ECG plot options are: Format Option 3+1 ECG Data 2.5 seconds of standard 12 leads in a 3-channel format, plus 10-second rhythm strip of one user-selectable lead in a 1-channel format. 6 5 seconds of standard 12 leads in a 6-channel format.
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MAINTENANCE AND TROUBLESHOOTING APPENDIX A System Troubleshooting Chart LCD Message Problem Correction BATTERY LOW – CHARGE UNIT Unable to acquire ECG or unable to print. Charge the battery with AC power. LEAD FAULT, NO ECG CAPTURE Lead fail or noisy ECG data. Correct faulty lead or noise. USB MEMORY USB memory stick not recognized or working Ensure the USB memory stick contains a “Records” directory. Verify device displays real-time ECG view. USB memory stick must be formatted to FAT 32.
APPENDIX A Recommendations to Biomedical Staff Following any service to the ELI 230 or when non-compliant operation is suspected, Mortara Instrument, Inc. recommends the following procedures: • • Confirm proper operation. Perform testing to ensure continued electrical safety of the device (use IEC 60601-1 or ANSI/AAMI ES1 methods and limits).
