Hillrom Welch Allyn ELI 380 User Manual
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Hillrom Welch Allyn ELI 380 User Manual

Resting electrocardiograph
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Welch Allyn
®
ELI
380
®
Resting Electrocardiograph
User Manual
Manufactured by Welch Allyn, Inc. Skaneateles Falls, NY U.S.A.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.

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Summary of Contents for Hillrom Welch Allyn ELI 380

  • Page 1 Welch Allyn ® ® Resting Electrocardiograph User Manual Manufactured by Welch Allyn, Inc. Skaneateles Falls, NY U.S.A. CAUTION: Federal law restricts this device to sale by or on the order of a physician.
  • Page 2 May be covered by one or more patents. See above Internet address. The Hill-Rom companies are the proprietors of European, US, and other patents and pending patent applications. Hillrom Technical Support For information about any Hillrom product, contact Hillrom Technical Support at 1.888.667.8272, mor_tech.support@hillrom.com. 80028617 Ver A...

  • Page 3: Table Of Contents

    TABLE OF CONTENTS NOTICES ................................5 ’ ............................5 ANUFACTURER ESPONSIBILITY ............................5 ESPONSIBILITY OF THE USTOMER ..............................5 QUIPMENT DENTIFICATION ............................ 5 OPYRIGHT AND RADEMARK OTICES ............................6 THER MPORTANT NFORMATION EU U ..........................6 OTICE TO SERS AND ATIENTS WARRANTY INFORMATION ..........................
  • Page 4 TABLE OF CONTENTS AM12M A ......................... 60 SING THE CQUISITION ODULE RECORD AN ECG ..............................61 ..............................61 ATIENT REPARATION ECG A ......................69 CQUISITION AND RINTING WITH CONNECTIVITY AND ECG TRANSMISSION ..................... 75 ECG T ................................75 RANSMISSION USB D ..............................

  • Page 5: Notices

    1. NOTICES Manufacturer’s Responsibility Welch Allyn, 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 Welch Allyn, 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.

  • Page 6: Other Important Information

    NOTICES Other Important Information The information in this document is subject to change without notice. Welch Allyn, 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. Welch Allyn, Inc. assumes no responsibility for any errors or omissions that may appear in this document.

  • Page 7: Warranty Information

    2. WARRANTY INFORMATION Your Welch Allyn Warranty WELCH ALLYN, INC. (hereafter referred to as “Welch Allyn”) warrants that components within Welch Allyn 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 Welch Allyn, or if not otherwise noted, for a period of twenty-four (24) months from the date of shipment.

  • Page 8: User Safety Information

    3. 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. NOTE: This manual may contain screen shots and pictures.
  • Page 9 USER SAFETY INFORMATION 14. This device does not automatically switch between direct or wireless acquisition modules. Clinician must choose the type of acquisition module before ECG acquisition. If your device is equipped with a receiver for a wireless acquisition module, always make sure that you are receiving data from the expected module. 15.
  • Page 10 USER SAFETY INFORMATION equipment. 25. Some Welch Allyn electrocardiographs can be equipped with a wireless LAN (WLAN) module for transmitting ECG records. Device labeling will indicate if your device is equipped with such a module. If so equipped, the following notices apply: The WLAN identification can be found on a label on the bottom of the device.
  • Page 11 USER SAFETY INFORMATION No user-serviceable parts are inside the WAM. Damaged or suspected inoperative equipment must be immediately removed from use and must be checked/repaired by qualified service personnel prior to continued use. This device is not recommended for use in the presence of imaging equipment such as Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) devices, etc.
  • Page 12 USER SAFETY INFORMATION Notes Patient movement 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. The algorithm detecting electrode reversal is based on normal physiology and ECG lead order, and tries to identify the most likely switch;...
  • Page 13 USER SAFETY INFORMATION 19. The device is UL classified: WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ES 60601-1(2005), CAN/CSA C22.2 No. 60601-1(2008), IEC 60601- 1(2005), E IEC 60601-2-25(2011) Wireless Data Transmission 20. ELI 380 electrocardiographs are equipped with a wireless data transmission module (WLAN). This technology uses radios to transmit data to a Welch Allyn receiving application.

  • Page 14: Equipment Symbols And Markings

    Follow instructions/directions for use (DFU) -- mandatory action. A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Hillrom for delivery within 7 calendar days.
  • Page 15 EQUIPMENT SYMBOLS AND MARKINGS Serial Number Non-ionizing electromagnetic radiation Version 2 UTK indicator (next to ECG Input) Medical Device Model Identifier Product reference Manufacturer Authorized representative in the European Community Global Trade Item Number Battery Charger level ECG Patient Cable Input Australian Communications and Media Authority (ACMA) Radio Compliance Mark (RCM).
  • Page 16 EQUIPMENT SYMBOLS AND MARKINGS KC Mark (South Korea) Radio approval symbol for Pakistan Conatel Approval symbol for Paraguay Eurasia Certification UL approved mark CE symbol Verbiage may vary. Background may be yellow if print is not black and white Do not re-use, Single use device Page | 16...
  • Page 17 EQUIPMENT SYMBOLS AND MARKINGS Lot number Use by date Not made with natural rubber latex Prescription only or "For Use by or on the order of a licensed medical professional" Page | 17...

  • Page 18: Package Symbol Delineation

    EQUIPMENT SYMBOLS AND MARKINGS Package Symbol Delineation Keep away from sunlight This way up Fragile Keep dry Temperature limit Humidity limitation Atmospheric pressure limitation Page | 18...

  • Page 19: Display Icons And Keyboard Buttons

    EQUIPMENT SYMBOLS AND MARKINGS Display Icons and Keyboard Buttons Patient Information ECG Acquisition Rhythm Print Synchronize Configuration Home Full disclosure page up ECG Acquisition from full disclosure selection Full disclosure page down Page | 19...

  • Page 20: General Care

    5. GENERAL CARE Precautions Power 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.

  • Page 21: Disposal

    Users must adhere to all federal, state, regional, and/or local laws and regulations as it pertains to the safe disposal of medical devices and accessories. If in doubt, the user of the device shall first contact Hillrom Technical Support for guidance on safe disposal protocols.

  • Page 22: Electromagnetic Compatibility (Emc)

    6. ELECTROMAGNETIC COMPATIBILITY (EMC) EMC compliance Special precautions concerning electromagnetic compatibility (EMC) must be taken for all medical electrical equipment. All medical electrical equipment must be installed and put into service in accordance with the EMC • information provided in this User Manual. Portable and mobile RF communications equipment can affect the behavior of medical electrical equipment.

  • Page 23: Wam And Amxx Guidance And Manufacturer's Declaration: Electromagnetic Emissions

    ELECTROMAGNETIC COMPATIBILITY (EMC) WAM and AMXX 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...
  • Page 24 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. Electromagnetic Environment: Immunity Test IEC 60601 Test Level...
  • Page 25 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 Immunity Test...

  • Page 26: Eli 380 With Laird Wb45Nbt Fips Compliant Wlan Module

    ELECTROMAGNETIC COMPATIBILITY (EMC) ELI 380 with Laird WB45NBT FIPS compliant WLAN module 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...
  • Page 27 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. Electromagnetic Environment: Immunity Test IEC 60601 Test Level...
  • Page 28 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 Immunity Test...

  • Page 29: Eli 380 With B&Belectronics Wlnn-Sp-Dp551 Non -Fips Wlan Module

    ELECTROMAGNETIC COMPATIBILITY (EMC) ELI 380 with B&B electronics WLNN-SP-DP551 Non-FIPS WLAN module 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...
  • Page 30 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. Electromagnetic Environment: Immunity Test IEC 60601 Test Level...
  • Page 31 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 Immunity Test...
  • Page 32 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.

  • Page 33: Regulatory Radio Compliance

    ELECTROMAGNETIC COMPATIBILITY (EMC) Regulatory Radio Compliance Federal Communications Commission (FCC) This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: This device may not cause harmful interference. • This device must accept any interference received, including interference that may cause undesired operation. •...

  • Page 34: Industry Canada (Ic) Emissions

    ELECTROMAGNETIC COMPATIBILITY (EMC) Industry Canada (IC) Emissions RF Radiation Hazard Warning Using higher gain antennas and types of antennas not certified for use with this product is not allowed. The device shall not be co-located with another transmitter. Cet avertissement de sécurité est conforme aux limites d'exposition définies per la norme CNR-102 at relative aux fréquences radio.

  • Page 35: European Union

    ELECTROMAGNETIC COMPATIBILITY (EMC) European Union Czech Welch Allyn tímto prohlašuje, ze tento WLAN device je ve shodě se základními požadavky a dalšími příslušnými ustanoveními směrnice 2014/53/ES. Danish Undertegnede Welch Allyn erklærer herved, at følgende udstyr WLAN device overholder de væsentlige krav og øvrige relevante krav i direktiv 2014/53/EF Dutch Bij deze verklaart Welch Allyn dat deze WLAN device voldoet aan de essentiële eisen en aan de overige relevante bepalingen van Richtlijn 2014/53/EC.

  • Page 36: Radio Compliance Table

    ELECTROMAGNETIC COMPATIBILITY (EMC) Radio Compliance Table Argentina Ente Nacional de las C-22663 (B&B) Comunicaciones C-21740 (Laird) (ENACOM) Australia Australian Communications and Media Authority (ACMA) Radio Compliance Mark (RCM). Brazil Agência Nacional de Este produto contém a placa 9373 Telecomunicações código de homologação ANATEL Modelo: B&B (ANATEL) B&B: 02432-19-10488...
  • Page 37 ELECTROMAGNETIC COMPATIBILITY (EMC) Date of approval: 13-SEP-2018 Laird: Approval number: MR 17582 ANRT 2018 Date of approval: 26/09/2018 Oman B&B R/6162/18 Telecommunications Regulatory Authority D172249 Pakistan Pakistan Telecom B&B Authority B&B: ESD - 1818097C Philippines National Telecommunications Laird: ESD – 1613022C Commission Singapore Info-Communications...

  • Page 38: Introduction

    7. INTRODUCTION Manual Purpose This manual is intended to provide the user with information about: Using and understanding the ELI™ 380 electrocardiograph, and the function control icons. • Preparing the ELI 380 for use. • • Acquiring, printing, and storing an ECG. •...

  • Page 39: System Illustration

    INTRODUCTION The device can operate on a single lithium-ion battery or AC line power. An optional second lithium-ion battery can be added for extended operating time. A capacitive-touch glass keyboard with navigational touchpad provides the user-interface. A swivel touchscreen is available.
  • Page 40 INTRODUCTION Side View Figure 2 ELI 380 Side with Writer Handle Writer Handle Rear View Figure 3 ELI 380 Rear with Connector Ports AMxx ECG connector port RJ45 LAN connector port USB connector port USB Device Port 100 – 240V power Page | 40...

  • Page 41: Base View

    INTRODUCTION Base View Figure 4 ELI 380 Base with Battery Compartment Battery Compartment Swivel Touchscreen Model The ELI 380 is available in a model that has a special touchscreen that swivels, side-to-side. Note: An on-screen keyboard is available mainly for languages other than English (Special characters).
  • Page 42 INTRODUCTION ELI 380 Capacitive-touch Glass Keyboard with Touchpad Figure 5 ELI 380 Keyboard Tab Key Function Control Keys Battery Power Indicator AC Power Indicator On/Off/Standby Button Shift Key Data Entry Keys Space Symbols Key Touch Pad The capacitive touchscreen is functional even when wearing gloves. Cleaning Mode To clean the touchscreen or keyboard, place the device into sleep mode.

  • Page 43: Display Overview

    INTRODUCTION Display Overview The ELI 380 features a 17” diagonal, bright LCD color display to preview the ECG waveform and other parameters as explained below. During ECG connection and acquisition, notification messages may appear on the display. (See Record an ECG.) Figure 6 ELI 380 Home Display with Full Disclosure Function Control Icons...
  • Page 44 INTRODUCTION Display Parameters Heart Rate (HR): HR displays in real time in the upper left corner when a patient is connected to the device. The heart rate in beats per minute is calculated and updated continuously during real-time ECG. NOTE: If a lead fail occurs, an indicator flashes in the center of the display and the HR number displays dashes until the lead failure is corrected.
  • Page 45 INTRODUCTION Function Control Icons Use the keyboard Function Control icons and the touchpad to select and complete patient information and ECG functions. The Configuration menu is also accessible in this manner. Patient Information Select this icon to either manually enter patient demographics or pick from the modality work list (MWL), patient list, or ELI 380 directory to find and download patient demographics.
  • Page 46 INTRODUCTION Configuration Menu (Settings) Selection of this icon allows any user to view the About menu, download a custom ID, set the time/date, switch between WAM and AMxx front-ends, test the WLAN connection, and print the system configuration. Access to advanced settings requires an administrative password to configure the system’s display and ECG acquisition format along with other settings.

  • Page 47: Specifications

    INTRODUCTION Specifications Feature Specifications Multi-lead resting electrocardiograph Instrument Type Input Channels Simultaneous acquisition of all leads Standard 12 Leads Acquired I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 Standard 15 Leads Acquired I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V7, V8, V9 12-lead Alternate Lead Groups Up to three additional groups can be labeled using any combination of 6 precordial leads with V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R, V6R,...
  • Page 48 INTRODUCTION Internal storage up to 500 ECGs ECG Storage Weight 22 lbs. (10 kg) including battery (without paper) (Standard Display Model) Weight 27 lbs. (12.5 kg) including battery (without paper) (Swivel Display Model) Closed Dimensions 15.5 x 20 x 5.5 in (39 x 51 x 14 cm) (Standard Display Model) Closed Dimensions 15.5 x 20 x 7 in (39 x 51 x 17.8 cm)
  • Page 49 INTRODUCTION Local Area Network (LAN) Specifications Feature Specifications Local Area Network (LAN) LAN Controller supports 10Base-T and 100Base-TX transfer rates (10Mb and 100 Mb RJ-45 connector provided on rear of device for LAN connection. IP address assignment Static or DHCP LAN indicators –...
  • Page 50 INTRODUCTION Wireless Local Area Network (WLAN) Option Specifications Wireless Network IEEE 802.11 a/b/g/n Interface Frequency 2.4 GHz frequency bands 5 GHz frequency bands 2.4 GHz to 2.483 GHz 5.15 GHz to 5.35 GHz, 5.725 GHz to 5.825Ghz Channels 2.4 GHz channels 5 GHz channels Up to 14 (3 non-overlapping);...

  • Page 51: Wam / Utk

    INTRODUCTION To ensure compliance with local regulations, be sure the access point corresponds with the country. This product can be used with the following restrictions: Norway - Does not apply for the geographical area within a radius of 20 km from the center of Ny-Ålesund.
  • Page 52 INTRODUCTION Paper Part Number Description 9100-026-52 SMART PAPER 9100-026-55 ARCHIVAL SMART PAPER (25 year life) Electrodes Part Number Description 108070 ECG MONITORING ELECTRODES CASE 300 108071 ELECTRODE RESTING TAB CASE/5000 Acquisition Modules Part Number Description 9293-048-54 WIRED PATIENT CABLE (AM12) W/O LEAD WIRES 9293-065-50 WIRED PATIENT CABLE (AM12M) W/O LEAD WIRES 9293-063-50...
  • Page 53 CBL BARCODE SCANNER USB 4800-017 ELI 380 LITHIUM-ION BATTERY ELI Link Part Number Description 11027-XXX-50 SOFTWARE ELI LINK V5.X.X 9515-166-50-CD SOFTWARE ELI LINK USER MANUAL ON CD Contact your dealer or go to www.hillrom.com for more information. Page | 53...

  • Page 54: Equipment Preparation

    8. EQUIPMENT PREPARATION Initial Startup When powering the ELI 380 on for the first time, the device requires the user to set certain configurations prior to obtaining an ECG: Custom ID (if applicable). Refer to the ELI Link user manual for instructions on how to set and change the Custom ID.

  • Page 55: Important Version Information For Wam (Wireless Acquisition Module)

    EQUIPMENT PREPARATION Important Version Information for WAM (Wireless Acquisition Module) There are two generations of WAM (Wireless Acquisition Module) and UTK (USB Transceiver Key). A legacy WAM and UTK and a newer version 2 WAM and UTK. How to physically identify the different WAM and UTK versions: A number 2 circular label on the back housing of the A number 2 located on the WAM label indicates a 30012-019- ELI electrocardiograph located next to the ECG...

  • Page 56: Eli 380 Configuration For All Users

    EQUIPMENT PREPARATION ELI 380 Configuration for All Users Select to enter the configuration menu. The following selections are available to all users. For more detail, refer to Configuration Settings. About: Upon selection of the Configuration function icon, information is initially displayed for the ELI 380 serial number, software version, DICOM enabled, WLAN enabled, LAN and WLAN MAC addresses.
  • Page 57 EQUIPMENT PREPARATION Loading Paper Figure 8 ELI 380 Paper Loading 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.

  • Page 58: Powering The Eli 380

    EQUIPMENT PREPARATION Powering the ELI 380 ELI 380 is an AC powered and battery operated device that can simultaneously charge the internal battery/batteries while connected to AC power. The device can be operated on AC line voltage in the absence of a battery, or in the event of a depleted battery.
  • Page 59 EQUIPMENT PREPARATION Power Status The ELI 380 has three distinct power states: Power On, Standby, and Off. While powered on, the ELI 380 performs all of its functions including display, acquisition, printing and transmission of ECGs. Powered by AC Power is automatically turned on when the device is connected to AC power. When a patient is connected, ECG is displayed and the On/Off/Standby button is not operational.

  • Page 60: Using The Wam Acquisition Module

    EQUIPMENT PREPARATION Using the WAM Acquisition Module ECG acquisition and rhythm strip printing can be performed at the WAM acquisition module in addition to the ELI electrocardiograph. To use the WAM, refer to the WAM user manual. The ELI 380 must be configured at the factory for use with the WAM. If the ELI 380 is configured for use with the WAM, the two devices must be paired to function properly.

  • Page 61: Record An Ecg

    9. RECORD AN ECG Patient Preparation Before attaching the electrodes, ensure the patient fully understands the procedure and what to expect. Privacy is very important in ensuring 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.
  • Page 62 RECORD AN ECG For accurate precordial (V or C) 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.
  • Page 63 RECORD AN ECG Alternate 12-Lead Placement ELI 380 supports combinations of alternate lead placement. The following three are defined as default selections. Pediatric utilizes V3R where the V3 lead should be positioned as shown in the diagram below. Posterior leads are V7, V8, and V9 where V1, V2, and V3 should be positioned as below. Right-sided leads are V3R, V4R, V5R, V6R, and V7R where leads V3 through V6 should be positioned as below.
  • Page 64 RECORD AN ECG 15- lead placement In a 15-lead configuration, three combinations of additional lead wires are available. The following are the factory- default lead sets: Pediatric: uses the right precordial leads V3R and V4R, and the posterior lead V7 Posterior: uses the posterior leads V7, V8, and V9 Right-sided: uses the right-sided leads V3R, V4R, and V6R NOTE: Attached to each 15 lead wire is a plug to be inserted into the AM15E.
  • Page 65 RECORD AN ECG Patient Demographic Entry Patient demographic information can be entered before acquisition. The entered patient ID fields will remain populated until the ECG signal is detected. The ELI 380 will prompt you with “Patient Hookup Is Required” before proceeding.
  • Page 66 RECORD AN ECG Automatically Entering Patient Demographics from the ECG Directory Patient demographics can be completed automatically by selecting an existing patient record in the directory. However, when user authentication is enabled, this option is only available when the user is logged in as a Technician or Administrator.
  • Page 67 RECORD AN ECG Automatically Entering Patient Demographics from the Patient List Patient demographics can be completed automatically by selecting patient information from the institution information system, or patient list. However, when user authentication is enabled, this option is only available when the user is logged in as a Technician or Administrator.
  • Page 68 RECORD AN ECG ECG Display Setup—Individual ECG The Display Setup screen allows you to set the following display configurations for an individual patient: display format, display speed, display (ECG) gain, display (ECG) filter, and full disclosure context view. Access these configuration choices by moving the cursor anywhere on the display’s real-time ECG waveform and tap the touchpad.

  • Page 69: Ecg Acquisition And Printing With Wam Or Amxx

    RECORD AN ECG ECG Acquisition and Printing with WAM or AMxx Control buttons located on the WAM and AMxx are available to initiate ECG acquisition and start/stop rhythm strip printing. From the patient demographic screen, the ECG button on the acquisition module will cause the real-time display to appear when patients are connected.
  • Page 70 RECORD AN ECG ECG Electrode Placement Troubleshooting Please refer to the following troubleshooting guide based on Einthoven’s Triangle: Artifact Check Electrode Possible Solutions Poor LL electrode or left leg Lead II and III artifact tremor Have patient relax tense muscles Lead I and II artifact Poor RA electrode or right arm tremor...
  • Page 71 RECORD AN ECG Critical Test Result Notification The Critical Test Results feature can be enabled to provide a specific message on the electrocardiograph when VERITAS finds criteria for an acute myocardial infarction or other critical ECG findings, signaling the user to alert a clinician for immediate attention.
  • Page 72 RECORD AN ECG Printing a Rhythm Strip . The Rhythm icon is replaced with a Done icon that will stop Begin printing a rhythm strip by selecting the rhythm strip printing and return you to the real-time ECG display. The function icon is also available—its selection will also cause a return to the real-time ECG display.
  • Page 73 RECORD AN ECG Editing Patient Demographics in a Stored ECG Record Use the following steps to edit patient demographics on a completed ECG stored in the Patient Directory. From the real-time ECG display, select to access the directory tab. In the Directory, locate the ECG record(s) by name, ID, or acquisition time/date and select from the list. Selection of a patient will display all ECG records for that patient in a list showing acquisition time as well as printed, transmitted, and to be deleted (meet the configured deleted rule) status.
  • Page 74 RECORD AN ECG Best 10 Second ECG The ELI 380 incorporates a 20-minute memory buffer for collection of ECG data. When Best10 is enabled, the device will automatically select the best quality 10-second ECG from within the last 5-minutes of stored ECG. The best 10 second determination is based upon measurement of high and low-frequency noise found in the 10-second ECG segments.

  • Page 75: Connectivity And Ecg Transmission

    10. CONNECTIVITY AND ECG TRANSMISSION ECG Transmission The ELI 380 can transmit acquired ECG records to ELI Link via LAN or WLAN. Before transmitting ECGs, certain configuration settings must be defined depending upon the type of transmission and type of electronic storage to be used.
  • Page 76 CONNECTIVITY AND ECG TRANSMISSION Transferring Individual Patient Records to the USB Memory Stick • Place the USB memory stick into the USB host port on the back of the device. Select from the real-time ECG view or the keyboard. • Select Directory.

  • Page 77: Ecg Review And Management

    11. ECG REVIEW AND MANAGEMENT Reviewing ECG Records With the ECG subdirectory displayed, tap on the desired record to select and display the ECG. Function icons for Print, Transmit, and Erase are available in the upper-right corner of the 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.

  • Page 78: Directory

    ECG REVIEW AND MANAGEMENT Directory The ECG directory saves up to 500 individual ECG records. Records are automatically deleted when they meet the delete rule configuration. To access the ECG directory, select from the real-time display and then tap the Directory tab if not displayed.
  • Page 79 ECG REVIEW AND MANAGEMENT When a patient is selected from the directory, a subdirectory is presented showing all ECG records stored for that patient with the acquisition date and time of each. Records that have been printed, transmitted, or marked to be deleted (meet the configured delete rule) will be indicated by an X in the appropriate column.

  • Page 80: Modality Worklist (Mwl)

    ECG REVIEW AND MANAGEMENT Modality Worklist (MWL) The ELI 380 can download and process ECG orders from compatible information management systems that identify the ECG orders for particular patients. Implementation of an order-based workflow can significantly reduce demographic data-entry errors at the electrocardiograph. Orders are deleted from the MWL when the ordered ECG is acquired.

  • Page 81: Patient List

    ECG REVIEW AND MANAGEMENT Patient List The ELI 380 can download and maintain a list of patients with their associated demographic information. ELI 380 is synchronized with a remote server in support of those institutions that would like to perform unordered tests. The Patient List directory saves up to 2,000 patients with ELI Link and an HL7 interface.
  • Page 82 ECG REVIEW AND MANAGEMENT PATIENT DEMOGRAPHIC QUERY (PDQ) The ELI 380 can allow user to query EMR based on demographic criteria (ID, First Name, Last Name) to download a list of patients with their associated demographic information. The PDQ feature will search based on any combination of fields (i.e.

  • Page 83: Configuration Settings

    12. CONFIGURATION SETTINGS Menu Commands and Utilities To access the ELI 380 configuration settings, select from the real-time display. Select Advanced for extended settings. Extended settings are password protected; the factory password is “admin”. When user authentication is enabled, these settings are accessible when logged in as an Administrator. NOTE: Select at any time to return to the real-time ECG display.
  • Page 84 CONFIGURATION SETTINGS UTILITY DESCRIPTION CHOICES ACCESS • Units for height Units for weight • XMT Mandatory Field – ID • • XMT Mandatory Field – Last Name XMT Mandatory Field – First • Name XMT Mandatory Field – DOB • •...
  • Page 85 CONFIGURATION SETTINGS Alternate Lead Presents default settings for 3 ADVANCED Lead Placement Name • Placement alternate lead selections. Password Required Various Lead Labels • Set the parameters needed for the ADVANCED Various parameter • Local Area Network. settings Password Required WLAN Set the parameters needed for the ADVANCED...

  • Page 86: Configuration Menu: About

    CONFIGURATION SETTINGS Configuration Menu: About Serial Number: Indicates the serial number of the electrocardiograph. Software Version: Indicates the software version of the electrocardiograph. DICOM: Indicates if DICOM bidirectional communication is available (Yes) or not (No). Security: Indicates if the user authentication and memory encryption feature is available (Yes) or not (No). WLAN: Indicates if Wireless Local Access Networking is in use (Yes or No).

  • Page 87: Configuration Menu: Date/Time

    CONFIGURATION SETTINGS Configuration Menu: Date/Time Year: Use the keyboard to enter the correct year in a four-character format (i.e., 2014). Month: Use the dropdown window to select the current month. Day: Enter the current day. Hour: Use the dropdown window to select the current hour. Use the up/down arrows to advance to more selections. Minute: Use the dropdown window to select the current minute.

  • Page 88: Configuration Menu: System

    CONFIGURATION SETTINGS Configuration Menu: System 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. In the event that an unknown language has been defined, use the following steps to change the language: Select from the real-time ECG display.
  • Page 89 CONFIGURATION SETTINGS Number of Barcode Postfix Digits: The number of characters to strip from the end of barcodes. Ignore Leading Barcode Zeros: Set to Yes if leading 0’s should be stripped from barcodes. Sync XMT: Set to Yes to allow automatic synchronization with the information system upon ECG transmission. Sync Patients: Set to Yes to allow synchronization with the information system patient list.

  • Page 90: Configuration Menu: Ecg

    CONFIGURATION SETTINGS Configuration Menu: ECG AC Filter: Selection allows the user to remove 60 Hz or 50 Hz interference on the ECG trace. The setting selection depends on the line frequency in the host country. Always use the 60 Hz setting in the United States. Filter: Selection allows the user to select the appropriate filtering for the desired trace results.
  • Page 91 CONFIGURATION SETTINGS Critical Test Result (CTR): Yes, for this option will enable the following: The ELI 380 will provide notifications to the user if an acquired ECG meets the CTR criteria The CTR feature will function even if ECG interpretation is disabled in the configuration menu. If the option is disabled, the user does not receive an audible or visual notification of CTR.
  • Page 92 CONFIGURATION SETTINGS ECG Capture: Defines whether the ELI 380 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.
  • Page 93 CONFIGURATION SETTINGS Number of Copies: Allows selection for the number of printed copies that automatically print when an ECG is taken. A zero (0) setting prints no copies. Selecting one (1) prints the original copy, two (2) prints the original plus one copy, and so on up to 9 copies.

  • Page 94: Configuration Menu: Alternate Placement

    CONFIGURATION SETTINGS Configuration Menu: Alternate Placement Alternate Lead Placement: Selection offers three alternate lead placements for V1 through V6 that can be assigned in this menu. ELI 380 is delivered with Pediatric, Posterior, and Right Sided lead sets as a default. The user can reassign the Lead Placement Names with entry of up to 12 characters.
  • Page 95 CONFIGURATION SETTINGS 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 380.

  • Page 96: Determine Wlan Module Type

    CONFIGURATION SETTINGS Determine WLAN Module Type Select from the real-time display Select Network Review Network screen (example below) If a line exists displaying “Welch Allyn F/W” followed by a version number, the Laird WB45NBT FIPS compliant WLAN module is installed. Otherwise, the B&B electronics WLNN-SP-DP551 Non-FIPS WLAN module is installed.
  • Page 97 CONFIGURATION SETTINGS In either DHCP setting, the following wireless network parameters must be provided by the IT professional: • Host IP • Port Number SSID • Channel Number • • Password or passphrase NOTE: Addresses are always entered as 4 sets of 3 digits; therefore, an address of 192.168.0.7 must be entered on the ELI 380 as 192.168.000.007.
  • Page 98 CONFIGURATION SETTINGS If your wireless security environment is WPA2 with EAP-TLS, then enter the following: Security: WPA2-EAP-TLS • FIPS: enter Yes or No • NOTE: FIPS selection field only available for units equipped with Laird WB45NBT FIPS compliant WLAN module. •...
  • Page 99 CONFIGURATION SETTINGS DHCP: Allows IT personnel to define whether the Dynamic Host Communication Protocol (DHCP) will be used to obtain an IP address. If DHCP is YES, the network will automatically and dynamically assign an IP address. • If DHCP is NO, the IT professional must enter the IP address, def gateway, and subnet mask. •...

  • Page 100: Configuration Menu: Passwords

    CONFIGURATION SETTINGS • WPA2-EAP-TLS: WPA2 interface with EAP-TLS requires client TLS certificates for authentication. FIPS: allows IT personnel to enter Yes or No NOTE: FIPS selection field only available for units equipped with Laird WB45NBT FIPS compliant WLAN module. RADIUS User Name: The RADIUS user name can be up to 64 alphanumeric characters in length. PEM Pass Password: The PEM Pass password can contain up to 64 alphanumeric characters in length.

  • Page 101: Maintenance And Troubleshooting

    13. 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. Ensure that AMxx or WAM are properly configured.
  • Page 102 MAINTENANCE AND TROUBLESHOOTING Affected Leads Problem Correction ARTIFACT / NOISE on All Leads High Freq. Noise. Adjust low pass filter setting to 150 or 40 Hz (see warning); check proximity to power cables; check AC filter setting (50 Hz or 60 Hz). Ensure patient is relaxed and muscles are not tense.

  • Page 103: Transmission Troubleshooting Chart

    MAINTENANCE AND TROUBLESHOOTING Transmission Troubleshooting Chart LCD Message Problem Correction TRANSMIT FAILED Unable to transmit ECG. Ensure site number is valid. Retry. ERROR-DICOM Not Enabled A DICOM communication was Configure the system to DICOM and attempted, but the unit is not reboot.

  • Page 104: Display Troubleshooting Chart

    MAINTENANCE AND TROUBLESHOOTING Display 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.

  • Page 105: Recommendations To Biomedical Staff

    MAINTENANCE AND TROUBLESHOOTING Recommendations to Biomedical Staff Following any service to the device or when non-compliant operation is suspected, Welch Allyn, Inc. recommends the following procedures: • Confirm proper operation. • Perform testing to ensure continued electrical safety of the device (use IEC 60601-1, ANSI/AAMI ES 60601-1, or IEC 62353 methods and limits).

  • Page 106: Appendix

    14. APPENDIX Loading Certificates on the ELI 380 Before you begin: Create a folder on the USB drive that will be used to load the certificates called “Certificates” Place certificate files into the “Certificates” folder. The ELI 380 will not load the certificates if the folder is not created with files inside.
  • Page 107 APPENDIX Once a selection has been made, additional options will appear. Enter the appropriate information. For WPA2-EAP-TLS, enter: i. RADIUS User Name ii. PEM pass phrase For WPA2-EAP-TLS (p12/pfx), enter: i. RADIUS User Name ii. Import Password Page | 107...
  • Page 108 APPENDIX 10. Next, select Certificates at the bottom of the screen. 11. The security protocol is listed at the top under “Security”. If an incorrect method was used, either go back to the previous page, or select and toggle to the alternate option in the drop down. 12.
  • Page 109 APPENDIX Select Load Certificates at the bottom of the page to load the certificates onto the wireless module. A message will appear if a failure occurs. NOTE: Allow the ELI 380 up to two minutes to complete saving the WLAN configuration. NOTE: To avoid accidentally saving ECGs to USB, remove the USB drive after the certificates have completed loading.

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