Mortara eli 150 инструкция на русском

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  REF 9515-167-51-ENG REV C1 ELI 150 Rx 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.
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  Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. E-Scribe, ELI, and VERITAS are trademarks of Mortara Instrument, Inc. Cisco ®…
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  E-mail: sales@mortara.com Mortara Instrument Germany European Union Kaninenberghöhe 50 Representative 45136 Essen Germany Mortara Rangoni Europe, Srl Tel: +49.201.18 55 69 70 (European Headquarters) Fax: +49.201.18 55 69 77 Via Cimarosa 103/105 40033 Casalecchio di Reno (BO) Mortara Instrument Netherlands…
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  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.
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  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.
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  UL 60601-1, IEC 60601-1, and IEC 60601-2-25. Only use parts and accessories supplied with the device and available through Mortara Instrument, Inc. • Patient cables intended for use with the device include series resistance (9 Kohm minimum) in each lead for defibrillation protection.
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  User Safety Information (Continued) • 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.
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  • 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.
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  User Safety Information (Continued) Note(s) • 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, is used simultaneously with the device;…
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  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…
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  User Safety Information (Continued) • The following table lists the frequency allocated for each channel used by the WLAN option. Channel Center Frequency Frequency Spread 2412 MHz 2399.5 MHz — 2424.5 MHz 2417 MHz 2404.5 MHz — 2429.5 MHz 2422 MHz 2409.5 MHz — 2434.5 MHz 2427 MHz 2414.5 MHz — 2439.5 MHz…
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  User Safety Information (Continued)
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  EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation Attention, consult accompanying documents Alternating current Protective earth 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 uppercase 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…
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  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.
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  General Care (Continued) Sterilization EtO sterilization is not recommended but may be required for cables and lead wires. Frequent sterilization will reduce the useful life of cables and lead wires. If required, sterilize with ethylene oxide gas (EtO) at a maximum temperature of 50°C/122°F.
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  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).
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  ELECTROMAGNETIC COMPATIBILITY (EMC) (Continued) 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…
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  ELECTROMAGNETIC COMPATIBILITY (EMC) (Continued) 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. Emissions Test IEC 60601 Test Level Compliance Level…
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  ELECTROMAGNETIC COMPATIBILITY (EMC) (Continued) 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. 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.

• Page 21: Table Of Contents

  Figure 1-5, ELI 150 Rx Display and Keyboard ……. . .

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  Table of Contents (Continued) SYSTEM SETTINGS SECTION 4 Section Purpose …………….. . 23 Accessing Configuration Menus .

• Page 23: Introduction Section

  Indications for Use The ELI 150 Rx 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.

• Page 24: System Description

  SECTION 1 System Description The ELI 150 Rx is a 12-lead diagnostic electrocardiograph capable of acquiring, viewing, transmitting, printing, and storing 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.

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  SECTION 1 ELI 150 Rx, Left Side Figure 1-2 ELI 150 Rx, Rear Figure 1-3…
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  SECTION 1 ELI 150 Rx, Base Figure 1-4…

• Page 27: Automatic Feature Keys

  SECTION 1 ELI 150 Rx, Display and Keyboard Figure 1-5 Automatic Feature Keys Automatic feature keys are used as a one-touch operation for: ECG Acquisition Rhythm Printing Transmitting Stop…

• Page 28: Display Overview

  • Heart Rate (HR): When a patient is connected to the ELI 150 Rx, 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.

• Page 29: Eli 150 Rx Specifications

  SECTION 1 ELI 150 Rx Specifications 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, 1/4 VGA LCD…

• Page 30: Accessories

  SECTION 1 Accessories Part Number Description 9100-028-01 ELI 150 Rx 4.25” x 5.5” thermal paper, cued Z-fold, full grid 9293-032-50 ELI standard patient cable, 12-lead, banana – AHA 9293-032-51 ELI standard patient cable, 12-lead, banana – IEC 9293-033-50 ELI standard patient cable, 12-lead, snap – AHA 9293-033-51 ELI standard patient cable, 12-lead, snap –…

• Page 31: Equipment Preparation Section

  EQUIPMENT PREPARATION SECTION 2 Section Purpose This section is intended to provide the user with information about: • Connecting the patient cable. • Loading paper. • Applying power. • Setting time, date, and LCD contrast. Connecting the Patient Cable Figure 2-1 Connect patient cable to the side connector…

• Page 32: Loading Paper

  š Slide writer 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 performance of thermal writer, be certain to use Mortara recommended thermal paper.

• Page 33: Applying Power

  Applying Power ‚ Plug the power cord into an AC wall outlet and into the back of the ELI 150 Rx. (Reference Figure 1-3.) Device powers on automatically and cannot be turned off when AC is connected (device is in Standby mode).

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  SECTION 2…

• Page 35: Record An Ecg Section

  RECORD AN ECG SECTION 3 Section Purpose This section is intended to provide the user with information about: • Patient preparation. • Patient hookup. • Patient demographic entry. • Acquiring, printing, and storing an ECG. • Acquiring rhythm strips. • Optional bar code scanner. Patient Preparation Before attaching the electrodes, assure the patient fully understands the procedure and what to expect.

• Page 36: Patient Hookup

  SECTION 3 Patient Hookup Correct electrode placement is important for acquiring a successful ECG. 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.

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  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.

• Page 38: Patient Hookup Summary Table

  SECTION 3 Patient Hookup Summary Table AAMI Lead IEC Lead Electrode Position Right side of the sternum in the 4th intercostal space. Left side of the sternum in the 4th intercostal space. Midway between V2/C2 and V4/C4. Left midclavicular line in the 5th intercostal space.

• Page 39: Patient Demographic Entry

  The patient demographic labels available are determined by the ID format selected in the configuration settings. In addition to short, standard, or long patient ID formats, the ELI 150 Rx also supports a custom ID format. The custom format, designed in an ELI LINK or E-Scribe™ Rx data management system, can be downloaded to the ELI 150 Rx.

• Page 40: Ecg Acquisition, Printing, Storage

  ECG is free from artifact (noise) due to patient activity. If workflow permits patient demographic entry prior to acquisition, connect the patient to the ELI 150 Rx and 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.

• Page 41: Printing

  ECG view. Storage The ELI 150 Rx manages storage in one of two ways – automatically or manually. When the auto-save configuration option is enabled, ECGs are automatically saved to the directory upon acquisition and printing. When the auto-save configuration option is disabled, the user is prompted to save the ECG after acquisition.

• Page 42: Acquiring Rhythm Strips

  See Section 4 for instructions to configure rhythm leads. Begin routine rhythm strips by connecting the patient to the ELI 150 Rx 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.

• Page 43: Optional Bar Code Scanner

  Mortara’s optional bar code scanner is purchased separately. By connecting the bar code scanner to the ELI 150 Rx’s RS-232 (serial port), all aspects of acquiring an ECG are automated for speed and accuracy of alphanumeric entry, functions, and feature processes.

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  SECTION 3…

• Page 45: System Settings Section

  SYSTEM SETTINGS SECTION 4 Section Purpose This section is intended to provide the user with information about: • Accessing configuration menus. • Summary of configuration options. • Detailed descriptions of configuration settings. Accessing Configuration Menus The configuration pages define all operational conditions that do not change on a daily or patient-to-patient basis.

• Page 46: Summary Of Configuration Menus

  SECTION 4 The following chart summarizes the configuration parameters and the available options for each field. Summary of Configuration Menus CONFIGURATION PARAMETER DEFINITION Software Version The software version of the unit Cart Number User defined (4 digits; 0 to 9999) Site Number User defined (4 digits;…

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  SECTION 4 Summary of Configuration Menus (continued) CONFIGURATION PARAMETER DEFINITION 6 Rhythm Lead 4 V1-V6, I, II, III, aVR, aVL, aVF 6 Rhythm Lead 5 V1-V6, I, II, III, aVR, aVL, aVF 6 Rhythm Lead 6 V1-V6, I, II, III, aVR, aVL, aVF Plot Format Channels printed: 3, 3+1, 3+3;…

• Page 48: Configuration

  Site Number (Second and Third site as well) The ELI 150 Rx allows for the configuration of up to three site numbers in order to manage multiple studies. A site is defined as a location from where an ECG is transmitted. In a research environment, it is recommended that site numbers designate the investigator’s site for ECG records stored in an E-Scribe Rx data management…

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  SECTION 4 Language There are several languages available on the electrocardiograph. CAUTION: Function labels are immediately translated upon selecting a new language and exiting the configuration screen. If an unknown language is visible, use the following steps to revert to the language of your country: 1.

• Page 50: Configuration

  AC Filter The ELI 150 Rx 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.

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  ECG. Using the example above, the acquisition date will print as 16-Jul-2003. Interpretation Option The ELI 150 Rx 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.

• Page 52: Configuration

  Defines whether or not a newly acquired ECG will be automatically saved to the directory once it is acquired and printed. If the auto-save configuration option is set to No and the record is printed, the ELI 150 Rx will prompt you to “Save ECG?” F1 (SAVE) will store the ECG in the directory.

• Page 53: Configuration

  SECTION 4 Auto-Print ECG Defines whether or not the ELI 150 Rx will automatically print the ECG after acquisition. If the selected configuration option is set to No, a manual printout is possible. Baud Rate Determines the serial port’s data transmission rate in bits per second (bps). Set the baud rate to 9600, 19200, 38400, 57600, or 115200 bps for direct data transmission between the ELI 150 Rx and another Mortara electrocardiograph;…

• Page 54: Configuration

  SECTION 4 Configuration Page 5 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. The ECG plot options are: Format Option ECG Data…

• Page 55: Configuration

  Enter the port number used by the host server. SSID Service Set Identifier (SSID) is the name of the wireless network. All ELI 150 Rx electrocardiographs that will transmit to the same network must have the same SSID name. This field is case sensitive.

• Page 56: Configuration

  Enter the 128-bit WEP key ID value (26 digits in 13 sets of two digits). WLAN MAC Shows the MAC address of the ELI 150 Rx wireless module for configuring access points. WPA-PSK WPA (Wi-Fi Protected Access) PSK (Pre-Shared Key) security allows for implementation of the “personal mode”…

• Page 57: Configuration

  Enter technician password. Worklist Management The ELI 150 Rx can download and process ECG order lists from the E-Scribe Rx or another compatible information management system which identifies the ECGs (or ECG orders) needed for particular patients. Implementation of an order-based workflow can significantly reduce demographic data entry errors at the electrocardiograph.

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  SECTION 4…

• Page 59: Section Purpose

  • ECG directory and directory maintenance. • Print configuration. The ELI 150 Rx offers several special functions available through the application menu. Select F6 (More) from the real-time ECG view and the application menu is displayed. The following chart summarizes the application functions available.

• Page 60: Print Configuration

  (with an “X” in the appropriate column). F6 (Exit) to return to the ECG directory. Print Configuration In order to verify the ELI 150 Rx’s configuration settings, a printout of the device’s configuration is possible from the application menu by selecting 2 (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.

• Page 61: Connectivity And Ecg Transmission

  NOTE: Telephone transmission is available with GSM/GPRS mobile or internal modem only. NOTE: In order to properly connect to telephone lines, the ELI 150 Rx 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.

• Page 62: Direct Connection (Rs-232)

  Modem Transmission For a modem transmission, set the XMT media to modem. Connect the ELI 150 Rx to a standard telephone jack with the provided phone line cable. Plug the cable into the telephone jack located on the back of the electrocardiograph and the other end into a telephone wall jack.

• Page 63: External Modem Country Code List

  APPENDIX A EXTERNAL MODEM COUNTRY CODE LIST: Country Code Country Code Afghanistan(AF) Chile(CL) Albania(AL) China(CN) Algeria(DZ) Christmas Island(CX) American Samoa(AS) Cocos (Keeling) Islands(CC) Andorra(AD) Colombia(CO) Angola(AO) Comoros(KM) Anguilla(AI) Congo(CG) Antarctica(AQ) Cook Islands(CK) Antigua and Barbuda(AG) Costa Rica(CR) Argentina(AR) Cote D’Ivoire(CI) Armenia(AM) Croatia(HR) Aruba(AW)

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  APPENDIX A Country Code Country Code Greenland(GL) Mali(ML) Grenada(GD) Malta(MT) Guadeloupe(GP) Marshall Islands(MH) Guam(GU) Martinique(MQ) Guatemala(GT) Mauritania(MR) Guinea(GN) Mauritius(MU) Guinea-Bissau(GW) Mayotte(YT) Guyana(GY) Mexico(MX) Haiti(HT) Micronesia(Federated States of)(FM) Heard and Mc Donald Islands(HM) Moldova-Republic of(MD) Honduras(HN) Monaco(MC) Hong Kong(HK) Mongolia(MN) Hungary(HU) Montserrat(MS) Iceland(IS) Morocco(MA)
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  APPENDIX A Country Code Country Code Rwanda(RW) Thailand(TH) St. Helena(SH) Togo(TG) Saint Kitts and Nevis(KN) Tokelau(TK) Saint Lucia(LC) Tonga(TO) St. Pierre and Miquelon(PM) Trinidad and Tobago(TT) Saint Vincent and the Grenadines(VC) Tunisia(TN) Samoa(WS) Turkey(TR) San Marino(SM) Turkmenistan(TM) Sao Tome and Principe(ST) Turks and Caicos Islands(TC) Saudi Arabia(SA) Tuvalu(TV)

• Page 66: Wlan Transmission

  NOTE: The range for the WEP key is 0-3. If the range on your access point is 1-4, then 0 at the ELI 150 Rx maps to 1 on the access point; 1 maps to 2 on the access point, etc.

• Page 67: Lan Transmission

  LAN Transmission For a LAN transmission, connect the ethernet cable to the LAN connection at the rear of the ELI 150 Rx and set the XMT media to LAN in the configuration. It is necessary that the IT Manager of your facility set the ELI 150 Rx LAN configuration values.

• Page 68: Sim Card Installation

  SIM Card Installation Power off the ELI 150 Rx. Open the writer cover and remove the pack of thermal paper. There is a small access panel on the floor of the writer tray. Remove the screw and lift off the access panel.

• Page 69: Orders Download

  Rx system. The technician at the electrocardiograph 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 ELI 150 Rx, 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.

• Page 70: Custom Id Download

  Custom ID formats are uniquely defined by your facility’s needs. This customized ECG header information is designed in an ELI LINK or E-Scribe Rx system and downloaded to the ELI 150 Rx. Up to three custom ID formats can be downloaded.

• Page 71: Maintenance And Troubleshooting

  MAINTENANCE AND TROUBLESHOOTING APPENDIX B System Troubleshooting Chart LCD Message Problem Correction BATTERY LOW – Unable to acquire ECG Charge the battery with AC power. CHARGE UNIT or unable to print. LEAD FAULT, NO Lead fail or noisy ECG data. Correct faulty lead or noise.

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  A link to the access point could Ensure the IP address is correct. If problem ACCESS POINT not be established. persists, contact Mortara Technical Service. CAN’T CONNECT TO A link to the access point was Ensure the IP address is correct. If problem…

• Page 73: Test Operation

  The sealed lead-acid battery will provide optimum life when the unit is fully charged after each use. The ELI 150 Rx will charge a depleted battery to 90% of its capacity in approximately 8 hours or less. To recharge a battery from its lowest level, 30 hours of recharging without operation will be necessary.

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  APPENDIX B…

• Page 75: Glossary

  GLOSSARY GLOSSARY TERM DEFINITION AAMI ECG lead names and identifying colors recommended by the Association for the Advancement of Medical Instrumentation. AC filter The configurable filter which screens out ECG artifact caused by power line interference. Artifact ECG waveform distortion that may diminish the quality of the ECG signal and may be caused by electrical interference, poor electrodes, poor patient prep, or poor connection.

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  GLOSSARY TERM DEFINITION Order Term for a physicians request for a 12-lead electrocardiogram. Power saving mode Term used for the electrocardiograph turning itself into a standby mode. The factory default is 10 minutes without operation or any ECG signal being detected. Precordial leads See Chest Leads.

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Manufacturer’s Responsibility

Mortara Instrument, Inc. is responsible for the effects on safety and performance only if:

•Assembly operations, extensions, readjustments, modifications, or repairs are carried out only by persons authorized by Mortara Instrument, Inc.

•The device is used in accordance with the instructions for use.

Responsibility of the Customer

The user of this device is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do so may cause undue failure and possible health hazards.

Equipment Identification

Mortara Instrument, Inc. equipment is identified by a serial and reference number on the back of the device. Care should be taken so that these numbers are not defaced.

Copyright and Trademark Notices

This document contains information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced, or translated to another language without prior written consent of Mortara Instrument, Inc.

Other Important Information

The information in this document is subject to change without notice.

Mortara Instrument, Inc. makes no warranty of any kind with regard to this material including, but not limited to, implied warranties of merchantability and fitness for a particular purpose. Mortara Instrument, Inc. assumes no responsibility for any errors or omissions that may appear in this document. Mortara Instrument, Inc. makes no commitment to update or to keep current the information contained in this document.

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. 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 Product/s caused by any or all of the following circumstances or conditions:

a)Freight damage;

b)Parts and/or accessories of the Product/s not obtained from or approved by Mortara;

c)Misapplication, misuse, abuse, and/or failure to follow the Product/s instruction sheets and/or information guides;

d)Accident; a disaster affecting the Product/s;

e)Alterations and/or modifications to the Product/s not authorized by Mortara;

f)Other events outside of Mortara’s reasonable control or not arising under normal operating conditions.

THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCT/S FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period. Mortara’s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Product/s (i) of all carrier charges with respect to any Product/s returned to Mortara’s principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable for loss, harm, or damage due directly or indirectly to an occurrence or consequence therefrom relating to the Product/s. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the Product/s when sold.

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 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.

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. Deviating from operating procedures, misuse or misapplication of the device, or ignoring specifications and recommendations could result in increased risk of harm to users, patients and bystanders, or damage to the device.

•Device captures and presents data reflecting a patient’s physiological condition that when reviewed by a trained physician or clinician can be useful in determining a diagnosis; however, the data should not be used as a sole means for determining a patient’s diagnosis.

•Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient care, and adequately trained in the use of this device. Before attempting to use this device for clinical applications, the operator must read and understand the contents of the user manual and other accompanying documents. Inadequate knowledge or training could result in increased risk of harm to users, patients and bystanders, or damage to the device. Contact Mortara service for additional training options.

•To ensure that electrical safety is maintained during operation from AC (~) power, the device must be plugged into a hospital-grade outlet.

•To maintain designed operator and patient safety, peripheral equipment and accessories used that can come in direct patient contact must be in compliance with UL 60601-1, IEC 60601-1, and IEC 60601-2-25. Only use parts and accessories supplied with the device and available through Mortara Instrument, Inc.

•Patient cables intended for use with the device include series resistance (9 Kohm minimum) in each lead for defibrillation protection. Patient cables should be checked for cracks or breakage prior to use.

•Conductive parts of the patient cable, electrodes, and associated connections of type CF applied parts, including the neutral conductor of the patient cable and electrodes, should not come into contact with other conductive parts including earth ground.

•ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or inflammation.

•To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with device or patient cables. Additionally, proper placement of defibrillator paddles in relation to the electrodes is required to minimize harm to the patient.

EQUIPMENT SYMBOLS AND MARKINGS

Symbol Delineation

Attention, consult accompanying documents

Alternating current

Protective earth

Telephone line (modem)

Network (LAN)

Defibrillator-proof type CF applied part

USB port

Input

ON/OFF (power)

Stop (of action)

Shift key (to enter upper case text)

Enter key (accept data/return)

Initiate printing of 12-lead ECG

Precautions

•Turn off the device before inspecting or cleaning.

•Do not immerse the device in water.

•Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents which may damage equipment surfaces.

Inspection

Inspect your equipment daily prior to operation. If you notice anything that requires repair, contact an authorized service person to make the repairs.

•Verify that all cords and connectors are securely seated.

•Check the case and chassis for any visible damage.

•Inspect cords and connectors for any visible damage.

•Inspect keys and controls for proper function and appearance.

Cleaning Exterior Surfaces and Patient Cable

1.Remove cables and lead wires from device before cleaning.

2.For general cleaning of cables and lead wires, use a soft, lint-free cloth lightly moistened with a mild soap and water solution. Wipe and air dry.

3.For disinfecting the cables and lead wires, wipe exterior with a soft, lint-free cloth using a solution of Sodium Hypochlorite (10% household bleach and water solution) minimum 1:500 dilution (minimum 100 ppm free chlorine) and maximum 1:10 dilution as recommended by the APIC Guidelines for Selection and Use of Disinfectants.

4.Use caution with excess liquid as contact with metal parts may cause corrosion.

5.Do not immerse cable ends or lead wires; immersion can cause metal corrosion.

6.Do not use excessive drying techniques such as forced heat.

WARNING: Prevent liquid from penetrating the device and do not attempt to clean/disinfect the device or patient cables by submerging into a liquid, autoclaving, or steam cleaning. Never expose cables to strong ultra-violet radiation. Do not sterilize the device or ECG lead wires with Ethylene Oxide (EtO) gas.

Cleaning the Device

Disconnect the power source. Clean the exterior surface of the device with a damp, soft, lint-free cloth using a solution of mild detergent diluted in water. After washing, thoroughly dry off the device with a clean, soft cloth or paper towel.

Cautions

Improper cleaning products and processes can damage the device, produce brittle lead wires and cables, corrode the metal, and void the warranty. Use care and proper procedure whenever cleaning or maintaining the device.

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 Table X-4 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.

INTRODUCTION

SECTION 1

Manual Purpose

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

•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)

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

•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.