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REF 9515-171-50-ENG Rev J1 ELI 350 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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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, E-Scribe, VERITAS, and WAM are trademarks of Mortara Instrument, Inc.
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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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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.
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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. •...
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Do not connect a telephone line cable to the LAN connector. • Some Mortara electrocardiographs can be equipped with a GSM (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.
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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 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. •...
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Some Mortara electrocardiographs can be equipped with an optional wireless data transmission module • (WLAN or GSM). Both these technologies use radios to transmit data to a Mortara receiving application. Due to the nature of radio transmissions, it’s possible that, due to the characteristics of the environment where the device is located, some other RF sources may interfere with the transmission generated by the device.
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USER SAFETY INFORMATION • 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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EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation Attention, consult accompanying documents Alternating current Protective earth Fuse Telephone line (modem) Network (LAN) Universal Serial Bus (USB) Defibrillator-proof type CF applied part Output/Transmit Input ON/OFF (power) Stop (of action) Shift key (to enter upper case text) Space key...
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EQUIPMENT SYMBOLS AND MARKINGS Enter key (accept data/return) Initiate acquisition of ECG Initiate printing of continuous rhythm strip SYNC Initiate transmission of records STOP Stop rhythm print out Do not dispose as unsorted municipal waste. Per European Union Directive 2002/96, requires separate handling for waste disposal according to national requirements Antenna Indicates compliance to applicable European Union 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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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.
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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...
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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. IEC 60601 Test Compliance Emissions Test...
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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. 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.
Figure 1-3, ELI 350, Rear View ............................ 4 Figure 1-4, ELI 350, Base View ............................ 5 Figure 1-5, ELI 350, Keyboard Touchpad ........................6 Figure 1-6, ELI 350, Keyboard Click Knob ........................7 Automatic Feature Keys ..............................7 Display Overview ................................8 Navigation Overview ..............................
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Configuration and Settings ............................52 MAINTENANCE AND TROUBLESHOOTING APPENDIX A Troubleshooting Charts ............................... 61 Power Off the ELI 350 ..............................63 Test Operation ................................63 Recommendations to Biomedical Staff ........................63 Battery Maintenance ..............................63 Cleaning the Thermal Printer ............................64...
• Using and understanding the ELI™ 350 electrocardiograph, the function and feature keys, the display screen, and navigating the user interface. • Preparing the ELI 350 for use. (Section 2) • Acquiring, printing, and storing an ECG. (Section 3) •...
SECTION 1 System Description The ELI 350 is a multi-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 6) 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 350, System Illustration Figure 1-1...
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SECTION 1 ELI 350, Side View Figure 1-2 ELI 350, Rear View Figure 1-3...
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SECTION 1 ELI 350, Base View Figure 1-4...
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SECTION 1 ELI 350, Keyboard Touchpad Figure 1-5...
SECTION 1 Display Overview The ELI 350 features a 17” 1280 x 1024 LCD display for valuable preview of ECG waveform and other parameters as explained below. Figure 1-7 “Softkey” Menu Items ID and Format Patient Heart Rate Menus Patient...
SECTION 1 • WAM/Direct Cable: Will display WAM™ (optional wireless acquisition module) or Direct Cable depending on the patient cable setting. • Date/Time and Battery Status. Current date/time and battery status displays on the lower right- hand side. See Section 2 for explanation of battery indications. •...
10,000 s/sec/channel used for pacemaker spike detection; 1000 s/sec/channel used for recording and analysis Special Functions Optional Mortara VERITAS resting ECG interpretation with age and gender specific algorithm; connectivity options for bidirectional communication; Exercise Stress option with report generation; Late Potential Paper Type Full-size (8.5 x 11”...
SECTION 1 Accessories Replacement Lead sets and Accessories Part Number Description 9042-057-02 LABELING LEAD WIRE V3R, V4R, V7 AHA/IEC 9042-057-02 LABELING LEAD WIRE V7, V8 , V9 AHA/IEC 9281-002-50 ADAPTER 4mm BAN PLG TO SNAP LDWIRE PK/10 9325-001-50 ADAPTER 4mm ALLIGATOR CLIP PK/10 9293-039-60 ECG CBL RDS TRUNK/YOKE 13/14 WIRE 9293-040-50...
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RPLCE LD SET WAM/AM12 V4-V6 CLIP AHA GRY 9293-047-67 RPLCE LD SET WAM/AM12 C4-C6 CLIP IEC GRY Paper Part Number Description 9100-026-50 PAPER ELI 350 US CASE/12/250 ZFOLD 9100-026-51 PAPER ELI 350 A4 CASE/12/250 ZFOLD Electrodes Part Number Description 9300-032-50...
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* This item is intended for single patient use. It is warranted to be free of defects in workmanship and materials for a period of 90 days or first use, whichever comes first. Contact your dealer or go to www.mortara.com for more information.
Connect patient cable to the patient-cable connector on the front left side of the device. When using the WAM for ECG acquisition, the connector is not required. Refer to the WAM user manual for pairing instructions to the ELI 350. Figure 2-1...
5. Slide paper tray cover to the right until the cover latches in a locked position. You will hear a sharp click when the cover is properly latched. WARNING: Risk of injury to fingers in paper door or platen drive mechanisms. NOTE: For proper performance of thermal printer, be certain to use Mortara recommended thermal paper.
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SECTION 2 A4 Paper Users If the device was ordered with A4 paper, the paper tray spacer will be inserted in the paper tray and the configuration option to use A4 paper will be set to YES. A paper tray spacer will not be provided if the device was purchased with standard paper.
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SECTION 2 Figure 2-4 2. The paper tray spacer should be parallel with the rear wall of the paper tray. Figure 2-5 3. Gently press paper tray spacer in place. 4. Set configuration option to use A4 paper. (See Section 6.) 5.
SECTION 2 Applying Power 1. Plug the power cord into an AC wall outlet and into the back of the ELI 350. (Reference Figure 1-3.) 2. Press the power ON/OFF button on the keyboard. Indicators on the keyboard will illuminate as follows: •...
In Standby mode, the ELI 350 is in a low power “sleep” mode. Standby allows the ELI 350 to conserve power while not in use, but provide “instant on” with startup. To turn the ELI 350 on from Standby, press and release the ON/OFF button with the display open or open the closed display to an upright position.
NOTE: Time synchronization will occur only if interfaced to a product which supports ELI-Link. Installing the WLAN Antenna The ELI 350 with optional WLAN module is shipped with the antenna not installed: the antenna can be found in the accessory box.
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.
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SECTION 3 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.
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SECTION 3 15-lead placement In a 15-lead configuration, three combinations of additional lead wires are available: 1. Right precordial leads V3R, V4R and posterior lead V7, or 2. Posterior leads V7, V8, V9, or 3. Physician preference lead placement E1, E2, E3. For limb leads and precordial leads V1 thru V6, follow the instructions for a standard 12-lead hookup as described previously.
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SECTION 3 For posterior leads: • V7: left posterior axillary line, horizontal with V6. • V8: left midscapular line, horizontal with V7. • V9: left paraspinal line, horizontal with V8. Lead Identification and Color Coding AAMI-Color Scheme IEC-Color Scheme Lead Label Lead ID Color Lead Label Lead ID Color...
ID format selected in the configuration settings. In addition to short, standard, or long patient ID formats, the ELI 350 also supports a custom ID format. The custom format, designed in ELI Link or an E-Scribe™ data management system, can be downloaded to the ELI 350. Additional information about the custom ID can be found in Section 4, or in the ELI Link and E-Scribe user manuals.
ECG or RHY you should instruct the patient to relax in a supine position to ensure that the ECG is free from artifact (noise) due to patient activity. With optional 15 lead, clinicians can use the Settings sub menu ECG SETTINGS to preset the ELI 350 for: •...
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.) •...
SECTION 3 Best 10 Seconds Selection The ELI 350 automatically selects the best 10 seconds from within the available 20-minute buffer. The user can use the suggested 10 seconds or navigate to a different ECG strip. If the BEST 10 mode is enabled in the configuration, the footer of the ECG screen (in both real time and preview) displays BEST 10 MODE.
Section 4 for instructions to configure rhythm leads. Begin routine rhythm strips by connecting the patient to the ELI 350 and entering the patient identification information. After the last data entry field from the ID menu is completed, select OK to return to the real-time ECG view.
The WLAN performance of the ELI 350 may vary due to changes in RF (radio frequency) properties at your site or to environmental conditions. If you are experiencing intermittent connectivity in certain areas of your facility, it may be necessary to re-initiate the transmission process.
Modem Transmission For a modem transmission, set the SYNC media to modem. Connect the ELI 350 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.
SECTION 4 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 Australia...
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SECTION 4 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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SECTION 4 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 Puerto Rico Tunisia...
LAN Transmission For a LAN transmission, connect the ethernet cable to the LAN connection at the rear of the ELI 350 and set the SYNC media to LAN in system settings. It is necessary that the IT Manager of your facility set the ELI 350 LAN configuration values.
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 350 maps to 1 on the access point; 1 maps to 2 on the access point, etc.
The ELI 350 can receive ECGs from another Mortara Instrument electrocardiograph. To receive an ECG, select Receive from the Settings menu. The ELI 350 only acts as a printer. Received ECGs will not be viewed or stored. To terminate the receiving mode, press the STOP key.
ECGs are retrieved by ID number. Enter the desired ID and select OK. E-Scribe transmits the most recent ECG with the specified ID number (or the configured number of ECGs retrieved – refer to Section 6). The ELI 350 prints the retrieved ECG(s);...
Custom ID formats are uniquely defined by your facility’s needs. This customized ECG header information is designed in ELI Link or an E-Scribe system and downloaded to the ELI 350. Select Custom ID Download from the application menu. “Transmission Status” will remain visible for approximately 10 seconds followed by “Waiting for Response”, “Connected”, and “Custom ID downloaded”.
ECG DIRECTORY SECTION 5 ECG Directory The standard ECG directory saves up to 200 individual ECG records. The optional expanded memory permits up to either 500 or 2,000 ECGs. To access the ECG directory, select Directory from the main display. NOTE: A password may be required in order to enter the ECG directory.
Last name:, First name:, ID:, DOB (date of birth):, or Acq. Time (acquisition time):. Once selected, return to the Search field to type in the search information. Show Deleted/Hide Deleted Allows for displaying or hiding ECGs marked as deleted. The ELI 350 displays only those records NOT marked as deleted by default. ECG Orders The ECG orders directory saves up to 256 ECG pending orders.
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Last name:, 1st name:, ID:, DOB (date of birth):, or Order date/time:. Once selected, return to the Search field to type in the search information. NOTE: The ELI 350 will maintain the last selected location used in the search process to help expedite work flow.
SYSTEM SETTINGS SECTION 6 Accessing the Format Menu Access the Format drop-down menus by selecting Format from the main display. Settings changed in the Format menus apply to the current acquisition setting only. The settings will revert back to the default settings once the session is completed.
Cancel – Exits Settings menu. Setting Passwords The ELI 350 is delivered with a preset administrator password (“admin”); type this password in the Settings screen and select ENTER or press the click knob to display the Setup Passwords screen. The top selection is dedicated to the administrator password; the lower selection is dedicated to the technician password.
SECTION 6 Summary of Configuration Menus Parameter Options Software version Displays software version on printout and display Cart Number Numeric field 0 to 65535 Site Number Numeric field 0 to 4095 Site Name Alphanumerical field (30 digits) Telephone number Alphanumerical field (45 digits) Language Available software languages Volume...
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SECTION 6 Summary of Configuration Menus (Continued) Parameter Options Use A4 paper YES/NO Caps lock YES/NO Rhythm Format 3, 6, or 12 channel I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 3 Rhythm Lead 1 optional V3R, V4R, V7 or V7, V8, V9 or E1, E2, E3 I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 3 Rhythm Lead 2 optional V3R, V4R, V7 or V7, V8, V9 or E1, E2, E3...
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SECTION 6 Summary of Configuration Menus (Continued) Parameter Options WEP Key Numeric (1 digit), valid range 1-4 (not on printout) WEP Key ID Alphanumerical field (26 digits) A-F, 0-9 (not on printout) LEAP Username Alphanumeric field (32 digits) (not on printout) LEAP Password Alphanumeric field (32 digits) (not on printout) PSK Passphrase...
Site Number Identifies the site of your ELI 350. Site numbers designate the hospital, clinic, or institution for ECG records stored in an E-Scribe system and must be defined for transmitting and retrieving ECGs from that system. You can use up to four digits for the site number.
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Brightness A/C Determines screen brightness level when the ELI 350 is powered by A/C mains. The ELI 350 is also equipped with an ambient light sensor that can adjust the brightness automatically. Set this parameter to Auto to allow the device to automatically set itself according to the ambient light source throughout the room.
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AC Filter The ELI 350 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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Serial Comparison When enabled, the ELI 350 will print a comparison of up to 4 previous ECGs along with the most current ECG from the patient directory. The ELI 350 will only do a serial comparison of the ECGs currently residing on the ELI 350.
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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 is set to No and the record is printed, the ELI 350 will prompt you to “Save ECG?”...
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38400 bps for a direct connection to an E-Scribe system. Use A4 Paper The ELI 350 accommodates use of Z-fold thermal paper in either letter size (8.5 x 11 inches; 216 x 279 mm) or A4 size (8.27 x 11.69 inches; 210 x 297 mm).
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SECTION 6 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 or optional 15 leads are always stored. ECG plot options are: Format Option ECG Data 2.5 seconds of standard 12 leads in a 3-channel format, plus 10-...
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SSID Service Set Identifier (SSID) is the name of the wireless network. All ELI 350 electrocardiographs that will transmit to the same network must have the same SSID name. This field is case sensitive.
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SECTION 6 Security (WEP) Wired Equivalent Privacy (WEP) is an encrypted security protocol (part of the 802.11 standard). Access points can have multiple WEP keys stored. Each one of them is identified by a number (e.g., 0, 1, 2, 3). WEP Key Enter the WEP key number;...
MAINTENANCE AND TROUBLESHOOTING APPENDIX A System Troubleshooting Chart LCD Message Problem Correction BATTERY LOW, Battery LED Unable to acquire ECG or Charge the battery with AC power. flashing on the front panel unable to print. LEAD FAULT, NO ECG Lead fail or noisy ECG data. Correct faulty lead or noise.
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APPENDIX A Transmission Troubleshooting Chart LCD Message Problem Correction Check phone line. Ensure site number TRANSMIT FAILED (MODEM) Unable to transmit ECG. is valid. Try again. Select Settings followed by Test WLAN to verify that an adequate RF signal TRANSMIT FAILED (WLAN) Unable to transmit ECG.
Power Off the ELI 350 Normally, the ELI 350 will go into a low-power stand-by state when the ON/OFF button is pressed briefly. To shutdown the ELI 350 completely, disconnect the AC power cord then press and hold the ON/OFF button for 4 seconds.
APPENDIX A Cleaning the Thermal Printer To clean the printer 1. Disconnect the power source. 2. Clean the exterior surface of the unit with a damp cloth using a solution of mild dishwashing detergent diluted in water. 3. 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.
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