REF 9515-181-51-ENG Rev G ELI 280 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.
NITIAL TARTUP ..........................31 ALIBRATING THE OUCHSCREEN ISPLAY ..........................31 ONNECTING THE CQUISITION ODULE ................................32 OADING APER ELI 280 ..............................35 OWERING THE ............................ 36 ATTERY AILSAFE ONDITIONS ................................36 OWER TATUS ..............................37 ETTING ATE AND ..............................37...
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............................41 ATIENT EMOGRAPHIC NTRY ECG A AM12 ....................... 44 CQUISITION AND RINTING WITH ECG A ................................44 CQUISITION 10 S ECG ..............................47 ECONDS OF ECG R ............................47 ONFIGURING THE EPORT ECG S ..............................48 CQUIRED TORAGE ............................... 48 CQUIRING HYTHM TRIPS...
Milwaukee, WI 53224 Tel: 414.354.1600 U.S.A. Tel: 800.231.7437 Tel: 414.354.1600 Fax: 414.354.4760 Fax: 414.354.4760 Internet: http://www.burdick.com Hospital Customers: orders.us@mortara.com Physician Practice: orderspc.us@mortara.com European Union U.S. Distribution: orderspc.us@mortara.com Representative Mortara Instrument Germany Hofgartenstraße 16 Via Cimarosa, 103/105 72379 Hechingen 40033 Casalecchio di Reno (Bologna)
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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. (hereafter referred to as “Mortara”) warrants that components within Burdick branded 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.
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WARRANTY INFORMATION 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 P E R I O D .
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 are available through Burdick/Mortara/Quinton. Patient acquisition devices intended for use with the device include series resistance (9 Kohm minimum) in each lead for defibrillation protection.
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The ELI 280 is a medical device that has 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: ...
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Do not connect a telephone line cable to the LAN connector. Some Burdick 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.
USER SAFETY INFORMATION Caution(s) To prevent possible damage to the touchscreen, do not use sharp objects to touch the screen icons, only use fingertips. Do not attempt to clean the device or patient acquisition device by submersing into a liquid, autoclaving, or steam cleaning as this may damage equipment or reduce its usable life.
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USER SAFETY INFORMATION The display of a thick baseline while using the AM12 acquisition module (square waves on rhythm printout) could be due to an improper auto-calibration. Reconnect the AM12 or power cycle the electrocardiograph. A square wave on the display and rhythm printout could be due to the WAM, the AM12, or lead wires not being connected to the patient.
Some Burdick electrocardiographs can be equipped with an optional wireless data transmission module (WLAN or GSM). Both these technologies use radios to transmit data to a Burdick 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.
EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation Attention, consult accompanying documents Alternating current Protective earth symbol (appears on inside of unit) Fuse symbol (appears on inside of unit) Telephone line (modem) Network (LAN) Universal Serial Bus (USB) Defibrillator-proof type CF applied part Input ON/OFF (power) ...
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EQUIPMENT SYMBOLS AND MARKINGS Patient Information Initiate Acquisition Of ECG Initiate Printing Of Continuous Rhythm Strip Initiate Transmission Of Records Stop Rhythm Print Out Configuration (Settings) Menu Home (returns user to the real-time acquisition screen)
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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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).
ELECTROMAGNETIC COMPATIBILITY (EMC) Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment: Guidance...
ELECTROMAGNETIC COMPATIBILITY (EMC) Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. IEC 60601 Test Compliance Emissions Test...
ELECTROMAGNETIC COMPATIBILITY (EMC) Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Equipment The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the equipment can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the equipment as recommended in the table below, according to the maximum output power of the communications equipment.
This manual is intended to provide the user with information about: Using and understanding the ELI™ 280 electrocardiograph, the touchscreen display, and the function control icons. Preparing the ELI 280 for use. Acquiring, printing, and storing an ECG. Connectivity and transmitting ECGs.
Supported print formats for the ELI 280 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. During rhythm strip printing the user can toggle between the various channels (default leads, limb and chest leads, etc.).
INTRODUCTION Rear View Figure 1-3 AM12 ECG connector port USB device port USB connector port RJ45 LAN connector port Modem port WLAN antenna connector 100 – 240V power Base View Figure 1-4 Battery Compartment...
INTRODUCTION Display Overview The ELI 280 features a 10.1” diagonal LCD color display to preview the ECG waveform and other parameters as explained below. During ECG acquisition, notification messages will also appear on the display. Figure 1-5 Patient Name Speed, Gain and Filter...
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Administrator – the user has been authenticated on the network with their User Name and Password, and the user has been granted Administrator permissions. In addition to Technician permissions, this user may also change the ELI 280’s settings. Battery Indicator: An icon indicating battery charge status displays in the upper right corner.
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These configuration settings become the default setting at power up and for each ECG test unless customized for an individual patient. NOTE: If a format change has been made during a specific test the ELI 280 will return to its default setting for the next patient.
INTRODUCTION Specifications Feature Specifications Instrument Type Multi-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 Backlit, 10.1” high-resolution color LCD Waveform Display Input Impedance Meets or exceeds the requirements of ANSI/AAMI/ IEC Input Dynamic Range 60601-2-25...
ARCHIVAL PAPER ELI 2XX A4 W/HDR CASE ARCHIVAL PAPER ELI 2XX A4 W/HDR CASE 9100-026-52 PAPER ELI 280 Smart Format CASE/12/250 ZFOLD (Spacer not included) ARCHIVAL PAPER ELI 2XX A4 W/HDR CASE 8342-007-02 PAPER TRAY SPACER: required for A4 and Smart paper use.
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POWER CORD CHINESE Manuals Part Number Description 9515-001-50-CD PHYSICIAN'S GUIDE ADULT & PEDIATRIC UM 9515-166-50-CD ELI LINK USER MANUALS 9515-181-51-CD BURDICK ELI 280 USER MANUALS 9516-181-51-ENG BURDICK ELI 280 SERVICE MANUAL Contact your dealer or go to www.burdick.com for more information.
EQUIPMENT PREPARATION Initial Startup When powering ON the ELI 280 the system requires the user to set certain configurations prior to obtaining an ECG: Date and time (including daylight savings time selection). Language. AC filter frequency. Height/weight units of measure.
EQUIPMENT PREPARATION Loading Paper Figure 2-2 Remove packaging and cardboard backing from the paper stack. Facing the front of the device, use the release latch on the left side and slide the paper tray cover to the left. 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.
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EQUIPMENT PREPARATION Smart and A4 Paper Users To use Smart or A4 paper, please insert the paper tray spacer: Figure 2-3 Slide paper tray spacer towards rear wall of paper tray. Align the bottom four plastic arms with the four openings in the base of the paper tray.
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EQUIPMENT PREPARATION Figure 2-4 The paper tray spacer should be parallel with the rear wall of the paper tray. Figure 2-5 Gently press paper tray spacer in place. Gently press on the top three plastic arms to remove the paper tray spacer.
When line voltage is removed the device immediately switches to battery power. Operating on AC Power Plug the power cord into an AC wall outlet and into the AC connector on the rear panel of the ELI 280. (Reference Figure 1-3.) ...
The ELI 280 automatically turns off after 15 minutes in Stand-by mode when on battery power and no patient is connected. The ELI 280 also turns off when battery voltage becomes too low. The operator can force the ELI 280 to screen.
Select Done to save and exit, or Cancel to exit without saving. Select Done again to return to the real-time display. Time Synchronization The SYNC feature allows time synchronization to occur only when the ELI 280 is interfaced to a product which supports ELI Link or E-Scribe. Select from the real-time display.
To use the WAM, refer to the WAM user manual. To use the AM12, refer to the AM12 short-form instruction card. The ELI 280 must be configured at the factory for use with the WAM. If the ELI 280 is configured for use with the WAM, the two devices must be paired to function properly.
RECORD AN ECG 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.
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RECORD AN ECG For accurate V-lead placement and monitoring, it is important to locate the 4 intercostal space. The 4 intercostal space is determined by first locating the 1 intercostal space. Because patients vary with respect to body shape, it is difficult to palpate the 1 intercostal space with accuracy.
The patient demographic labels available are determined by the ID format selected from the configuration settings. In addition to short, standard, and long patient ID formats, the ELI 280 also supports a custom ID format. The custom ID format designed in ELI Link or E-Scribe can be downloaded to the ELI 280. Additional information about the custom ID can be found in ECG Directory or in the ELI Link and E-Scribe user manuals.
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Fill in any remaining fields. Touch Done to return to the real time display. NOTE: If ELI Link is configured for DICOM, the DICOM option must be installed on the ELI 280, and its Communication Protocol must be set for DICOM32 or DICOM32ext.
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When the barcode scanner is programmed to parse several demographic values from a barcode, the user may scan the barcode from the main screen. When a barcode is scanned from the main screen and the ELI 280 detects multiple lines of text, it automatically jumps to the patient demographics form and copies the values into the form.
RECORD AN ECG ECG Display Setup – Individual ECG The Display Setup screen allows the user to set the following display configurations for an individual patient: display format, display speed, display (ECG) gain, and display (ECG) filter. Access these configuration choices by pressing anywhere on the touchscreen’s real-time ECG waveform.
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Low battery detected in the Replace the batteries in the WAM. Searching for WAM WAM not detected. WAM Check WAM proximity to the ELI 280; may be out of range, check WAM AA battery is new and powered OFF, depleted that the WAM is powered ON.
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RECORD AN ECG Press . 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: When Mandatory Fields are configured, and not populated at time of acquisition, and the “Done” button is selected, the user will be presented with a message requiring an acknowledgment prior to proceeding or exiting to home screen.
Configuring the ECG Report The ELI 280 can automatically print up to nine copies of the ECG report following acquisition. Print format, trace speed, ECG gain, ECG filter setting and pacer channel can be set as a default in the Configuration menu, or configured per ECG by touching the red grid screen display.
You can print a rhythm strip of the real-time ECG viewed on the display. Rhythm strips from the real-time ECG display can be acquired with the patient connected to the ELI 280 and after patient identification information is entered. A rhythm strip may also be printed without entering the patient ID by NOTE: Printed rhythm acquisitions are not stored in the ELI 280.
NOTE: Telephone transmission is available with internal modem only. NOTE: In order to properly connect to telephone lines, the ELI 280 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.
Select Advanced. Select Modem. Connect an active telephone line cable to the telephone jack, located on the back of the ELI 280. Confirm the telephone number in the configuration settings. Internal Modem Initialization The modem initialization string code is configured for the country where the system was shipped. If the system is relocated to a different country the modem initialization string code will need to be reprogrammed.
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CONNECTIVITY AND ECG TRANSMISSION External Modem Country Code List Country Code Country Code Afghanistan Canary Islands Albania Cape Verde Algeria Cayman Islands American Samoa Central African Republic Andorra Chad Angola Chile Anguilla China Antigua and Barbuda Colombia Argentina Congo Armenia Congo, The Democratic Republic of the Aruba Cook Islands...
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CONNECTIVITY AND ECG TRANSMISSION Country Code Country Code Cambodia French Polynesia Cameroon Gabon Canada Gambia Georgia Korea, Republic of (South Korea) Germany Kyrgyzstan Ghana Lao People's Democratic Republic Gibraltar Latvia Greece Lebanon Greenland Liberia Grenada Libya Guadeloupe Liechtenstein Guam Lithuania Guatemala Luxembourg Guernsey, C.I.
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CONNECTIVITY AND ECG TRANSMISSION Country Code Country Code Niger Nicaragua Nigeria Swaziland Norway Sweden Oman Switzerland Pakistan Syrian Arab Republic Palestine Territory, Occupied Taiwan Panama Tajikistan Papua New Guinea Tanzania, United Republic of Paraguay Thailand Peru Thaiti Philippines Togo Poland Tonga Portugal Trinidad and Tobago...
Ethernet Transmission Status Indicator LEDs The operator can monitor LAN interface connection and data transmission by observing the LEDs (Light Emitting Diodes) located at the system’s external connector. The LEDs can be viewed from the outside (rear) of the ELI 280. LED LOCATION...
To set up the ELI 280 for WLAN transmission: Select from the real-time display. Select Advanced. Select WLAN. Configure the ELI 280 for Dynamic Host Communication Protocol (DHCP) or static IP. Wireless security encryption options include: WEP 128 ...
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 ELI 280 maps to 1 on the access point; 1 maps to 2 on the access point, etc.
CONNECTIVITY AND ECG TRANSMISSION USB Connectivity Transmission using the USB host port to a USB memory stick USB memory communication media permits storage of patient records to an external USB memory stick. The files will be saved in UNIPRO32 format for transfer to the E-Scribe or a compatible electronic information management system.
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When properly connected, the PC will automatically detect the device and automatically install the drivers. You will be required to power the ELI 280 on by pressing the On/Off button for a period of three seconds. Transmitting Patient Records to ELI Link ...
ECG DIRECTORY ECG Directory The standard ECG directory saves up to 40 individual ECG records. The optional expanded memory permits up to 200 ECGs to be stored. To access the ECG directory, select from the real-time display, followed by Directory. Sort the directory by Name or ID by touching the header of choice.
ECG DIRECTORY Reviewing ECG Records To review an existing patient ECG record: Select from the real-time display, followed by Directory Navigate to the desired patient record, and select. Select the desired acquired ECG from the sub directory. Once selected the acquired ECG will display. To change the format of the acquired ECG touch the display and select the desired settings for Print Format, Print Speed, Print Gain, Print Filter and Pacer channel.
Sort, navigate and/or search ECG Orders in the same manner as the ECG Directory. NOTE: Each time orders are downloaded the ELI 280 will automatically refresh the orders list. Orders that have been executed, canceled or deleted will be automatically eliminated.
The number of pages, as well as the current page, displays to the left of the double arrows. NOTE: The ELI 280 will maintain the last selected queried location used in the search process to help expedite work flow.
Once a query code is selected it will serve as the default query code for that particular ELI 280, or until a different selection is made. Select None to erase the last query code used.
Patient Demographic Query (PDQ) The ELI 280 can query the EMR for patient demographic information via HL7 A19 using the input of up to three demographic criteria (ID, First Name, Last Name, or any combination of the three fields) for those institutions performing unordered ECG tests, or do not have an interface to an electronic ordering system.
WAM. the ELI 280 Change acquisition module to AM12. TEST WLAN Tests the strength of the radio frequency (RF) signal of the ELI 280 to the wireless network. System Presents the following system setting Language ADVANCED ...
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Clear flags Fill Directory IIR On Print Prints the configuration of the ELI 280. Done Exits the utility and saves the setting. Returns to the previous menu screen Home Exits the menu. Returns to the real-time display...
Administrator password in a location where it can be accessed during an emergency as well as in a backup location in case the primary location is compromised. The ELI 280 is preset with the case-sensitive Administrator password “admin.” To change the Administrator password, see Setting Passwords.
SYSTEM SETTINGS Configuration Settings: About Serial Number This indicator allows the user to see the serial number of the electrocardiograph. Software Version This indicator allows the user to see the software version of the electrocardiograph. Interp This selection allows the user to see whether automatic ECG interpretation is available on the device. Memory Capacity This indicator allows the user to see the storage capacity that the electrocardiograph currently possesses.
This indicator allows the user to see if a bar code scanner can be used with the device. Battery Voltage This indicator allows the user to see the ELI 280’s current battery voltage. Security This indicator allows the user to see if the Security features are enabled: ...
SYSTEM SETTINGS Configuration Settings: System Follow these steps to change the ELI 280 system settings: Select from the real-time display. (Enter password if required.) Select Advanced, followed by System. (A password is required to enter Advanced settings.) Make the appropriate configuration changes.
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MM/DD (month/day) or DD.MM (day.month) format. Cart Number This control allows the user to assign an ELI 280 with a cart number from 0 to 65535 in order to identify which device acquired or transmitted a particular ECG.
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ECGs, but no authentication of the user is performed against Local network credentials from another system. The user must enter the ELI 280’s Technician or Administrator password to obtain the respective permissions. This mode authenticates users over the network using Active Directory or LDAP and...
Auto Log Off When user authentication is used, this setting specifies the number of minutes the ELI 280 may remain idle before it automatically logs the user off. The device is idle when there is no patient connected and the screen is off. The user may manually put the device into an idle state by lightly pressing the power button.
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SYSTEM SETTINGS NOTE: The plot-frequency filter does not filter the digitized signal acquired for interpretation of the ECG. NOTE: The Filter setting can also be changed for a single ECG by touching anywhere on the ECG waveform in the real-time or acquired view. Interp This selection allows the clinician to turn the ECG interpretation statements On/Off for presentation on the display and/or plotted report.
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Fridericia corrected QT value along with the default linear QTc value. ECG Capture Defines whether or not the ELI 280 will automatically display the Best 10 seconds of data acquired or the last 10 seconds of data acquired. NOTE: The ECG Capture Mode can also be changed for a single ECG by touching anywhere on the ECG waveform in the acquired view.
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Cabrera Defines whether or not the ELI 280 will automatically display the ECG in the Cabrera format. The Cabrera format displays the limb leads in the order aVL, I, -aVR, II, aVF, III, instead of the standard I, II, III, aVR, aVL, aVF, allowing a different presentation of waveform progression in the vertical plane.
SYSTEM SETTINGS Rhythm Formats This control allows the user to set the default values for rhythm printing. Set the default rhythm format to 3, 6, 8 or 12-channel printing. NOTE: The Rhythm Print Speed and Format can also be changed for a single ECG by touching anywhere on the ECG waveform in the real time view.
This utility allows the IT professional to enter the sub net address (if DHCP is not selected). SSID Service Set Identifier (SSID) is the name of the wireless network. All ELI 280 electrocardiographs that will transmit to the same network must have the same SSID name. Touch the field to display the touchscreen keyboard.
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Select this mode when the WLAN uses EAP-TLS and client-side X.509 certificates to authenticate devices. Insert a USB flash memory stick into the back of the ELI 280 that contains the X.509 certificate. Touch the Certificates button to enter the Select Certificates screen. Select the appropriate certificates for the Root Certificate File, Private Key File, and Client Certificate File fields.
Configuration Settings: WAM Selecting WAM allows the clinician to switch between WAM or AM12 patient interface cables. For pairing of the WAM with the ELI 280, please refer to the WAM user manual. Configuration Settings: Service Please refer to the Service manual for definitions and assistance with the Service functions.
MAINTENANCE AND TROUBLESHOOTING System Troubleshooting Chart LCD Message Problem Correction BATTERY LOW – CHARGE UNIT Unable to acquire ECG or Charge the battery with AC power. unable to print. LEAD FAULT, NO ECG CAPTURE Lead fail. Correct faulty lead. NO ANSWER Unable to transmit ECG.
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MAINTENANCE AND TROUBLESHOOTING Transmission Troubleshooting Chart (continued) LCD Message Problem Correction CAN’T CONNECT TO REMOTE A link to the access point was Ensure the IP address is correct. If LINK established, but the link to the problem persists, contact Mortara destination failed.
MAINTENANCE AND TROUBLESHOOTING Touchscreen Troubleshooting Chart LCD Message Problem Correction Screen is dark The AC power cord is not Ensure that AC power cord is not connected to a grounded damaged and is firmly connected to AC electrical outlet or is damaged. power connector on rear of electrocardiograph.
For information about replacing the battery, please refer to the device’s service manual. Mortara Instrument, Inc. and Burdick recommend 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”...
MAINTENANCE AND TROUBLESHOOTING Cleaning the Thermal Printer To clean the printer Disconnect the power source. Clean the exterior surface of the unit with a damp cloth using a solution of mild detergent diluted in water. After washing, thoroughly dry off the unit with a clean, soft cloth or paper towel. To clean the print head NOTE: Do not let soap or water come into contact with the writer, plugs, jacks, or vents.