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.
© 2021 Welch Allyn This document contains confidential information that belongs to Welch Allyn, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Welch Allyn, Inc. Welch Allyn is a registered trademark of Welch Allyn, Inc. AM12, ELI, VERITAS, and WAM are trademarks of Welch Allyn, Inc.
TABLE OF CONTENTS 1. NOTICES .............................................................................................................................................................. 5 MANUFACTURER’S RESPONSIBILITY ........................................................................................................................................ 5 RESPONSIBILITY OF THE CUSTOMER .........................................................................................................................
TABLE OF CONTENTS USING THE AM12M ACQUISITION MODULE ......................................................................................................................... 60 9. RECORD AN ECG ................................................................................................................................................ 61 PATIENT PREPARATION ...................................................................................................................................................
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.
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. Welch Allyn, Inc. makes no commitment to update or to keep current the information contained in this document.
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.
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. Any screen shots and pictures are provided for reference only. Consult the actual screen in the host language for specific wording. WARNINGS 1. 2.
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. This device was designed to use the electrodes specified in this manual.
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.
7. 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. 8. 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. 9.
USER SAFETY INFORMATION Notes 1. Patient movement may generate excessive noise that may affect the quality of the ECG traces and the proper analysis performed by the device. 2. Proper patient preparation is important to proper application of ECG electrodes and operation of the device. 3.
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 606011(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.
4. EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. In addition, when used on a patient applied part, this symbol indicates defibrillation protection is in the cables. Warning symbols will appear with a grey background in a black and white document.
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).
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.
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
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
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
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. • • • • Verify that all cords and connectors are securely seated.
GENERAL CARE WARNING: Prevent liquid from penetrating the device and do not attempt to clean/disinfect the device or patient cables by submerging into a liquid, autoclaving, or steam cleaning. Do not expose cables to strong ultra-violet radiation. Do not sterilize the device or lead wires with Ethylene Oxide (EtO) gas. Do not immerse cable ends or lead wires; immersion can cause metal corrosion. Use caution with excess liquid as contact with metal parts may cause corrosion.
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.
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 RF Emissions CISPR 11 Group 1 The equipment uses RF energy only for its internal function.
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 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 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 RF Emissions CISPR 11 Group 1 The device uses RF energy only for its internal function.
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 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 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.
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 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 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.
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. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of FCC Rules.
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. This device complies with RSS 210 of Industry Canada.
ELECTROMAGNETIC COMPATIBILITY (EMC) European Union Czech Danish Dutch English Estonian Finnish French German Greek Hungarian Italian Latvian Lithuanian Malti Portuguese Slovak Slovene Spanish Swedish Welch Allyn tímto prohlašuje, ze tento WLAN device je ve shodě se základními požadavky a dalšími příslušnými ustanoveními směrnice 2014/53/ES.
ELECTROMAGNETIC COMPATIBILITY (EMC) Radio Compliance Table Argentina Australia Brazil Ente Nacional de las Comunicaciones (ENACOM) Australian Communications and Media Authority (ACMA) Radio Compliance Mark (RCM). Agência Nacional de Telecomunicações (ANATEL) C-22663 (B&B) C-21740 (Laird) Modelo: B&B 02432-19-10488 Modelo: Laird 01130-15-08547 EAC Keterangan a. [36491/I/SDPPI/2017] (Laird) adalah nomor sertifikat yang diterbitkan untuk setiap alat dan perangkat telekomunikasi b.
ELECTROMAGNETIC COMPATIBILITY (EMC) Date of approval: 13-SEP-2018 Laird: Approval number: MR 17582 ANRT 2018 Date of approval: 26/09/2018 Oman Telecommunications Regulatory Authority Pakistan Pakistan Telecom Authority B&B Philippines National Telecommunications Commission Info-Communications Media Development Authority (IMDA) Korea Communications B&B: ESD - 1818097C Laird: ESD – 1613022C Singapore South Korea Commission (대한민 국 방송통 신위원 회) – KCC Certification number: B&B: R-C-BVT-9373 Laird: MSIP-
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. • Connectivity and transmitting ECGs. • Managing the ECG directory, MWL Orders, and the Patient List. • Configuration settings. • Maintenance and troubleshooting. NOTE: This manual may contain screen shots.
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. A USB bar code reader for demographic text entry and navigation is optional. 12-lead ECGs can be printed in standard and Cabrera 1-page 3+1, 6+6, 3+3, and 12 channel layouts as well as a 2page 6 channel layout.
INTRODUCTION Side View Figure 2 ELI 380 Side with Writer Handle Writer Handle Rear View Figure 3 ELI 380 Rear with Connector Ports 1 2 1 2 3 4 5 3 4 5 AMxx ECG connector port RJ45 LAN connector port USB connector port USB Device Port 100 – 240V power Page | 40
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). Users in English speaking markets should generally avoid using this feature. In other languages, press the ALT key twice to start the on-screen keyboard.
INTRODUCTION ELI 380 Capacitive-touch Glass Keyboard with Touchpad Figure 5 ELI 380 Keyboard Function Control Keys Tab Key Battery Power Indicator AC Power Indicator A l t K e y 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. Press the power On/Off button on the keyboard once for less than 7 seconds.
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 User Name, Role, Speed, Gain, Filter, WAM with RF signal power (or AMXX), date, and current time b.
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. Patient Name: The patient’s last and first name are presented in the upper left corner of the display.
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.
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. These configuration settings become the default setting at power up and for each ECG test.
INTRODUCTION Specifications Feature Specifications Instrument Type Multi-lead resting electrocardiograph 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, V
INTRODUCTION ECG Storage Internal storage up to 500 ECGs Weight (Standard Display Model) 22 lbs. (10 kg) including battery (without paper) Weight (Swivel Display Model) 27 lbs. (12.5 kg) including battery (without paper) Closed Dimensions (Standard Display Model) 15.5 x 20 x 5.5 in (39 x 51 x 14 cm) Closed Dimensions (Swivel Display Model) 15.5 x 20 x 7 in (39 x 51 x 17.
INTRODUCTION Local Area Network (LAN) Specifications Feature Local Area Network (LAN) Specifications 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.
INTRODUCTION Wireless Local Area Network (WLAN) Option Specifications Wireless Network Interface Frequency Channels Security Modes Antenna Wireless Data Rates IEEE 802.11 a/b/g/n 2.4 GHz frequency bands 2.4 GHz to 2.483 GHz 2.4 GHz channels Up to 14 (3 non-overlapping); country dependent 5 GHz frequency bands 5.15 GHz to 5.35 GHz, 5.725 GHz to 5.
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. France - Outdoor use is limited to 10 mW EIRP (Effective Isotropic Radiated Power) within the band 2454 to 2483.5 MHz. Note Some countries restrict the use of 5-GHz bands. The 802.
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 WIRED PATIENT CABLE (AM15) W/O LEAD WIRES 30012-019-55 WIRELESS ACQUISITION MODULE (WAM+) W/O
INTRODUCTION Miscellaneous Part Number Description 99030-916HS 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.
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: 1. 2. 3. 4. Custom ID (if applicable). Refer to the ELI Link user manual for instructions on how to set and change the Custom ID. Date and time, including daylight savings start and end time selection. Configure the acquisition module. Advanced ECG and system settings. Refer to Configuration Settings for instructions.
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 located on the WAM label indicates a 30012-01956 version 2 WAM. If this number 2 label is not present it indicates a version 1 WAM.
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. Custom ID: Selection of this function will initiate download of the Custom ID.
EQUIPMENT PREPARATION Loading Paper Figure 8 ELI 380 Paper Loading 1. 2. 3. 4. 5. 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. The paper cue mark (a small black rectangle) should be in the lower left corner.
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. When AC power 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 back of the ELI 380. (See Figure 3.
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.
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. Please see the WAM user manual for pairing instructions.
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. • Make sure the patient is lying down and is comfortable. If the table is narrow, tuck the patient’s hands under his/her buttocks to ensure their muscles are relaxed.
RECORD AN ECG For accurate precordial (V or C) lead placement and monitoring, it is important to locate the 4th intercostal space. The 4th intercostal space is determined by first locating the 1st intercostal space. Because patients vary with respect to body shape, it is difficult to palpate the 1st intercostal space with accuracy. Thus, locate the 2nd intercostal space by first palpating the little bony prominence called the Angle of Louis, where the body of the sternum joins the manubrium.
RECORD AN ECG Alternate 12-Lead Placement ELI 380 supports combinations of alternate lead placement. The following three are defined as default selections. 1. 2. 3. 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.
RECORD AN ECG 15- lead placement In a 15-lead configuration, three combinations of additional lead wires are available. The following are the factorydefault lead sets: 1. 2. 3. 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. Each plug has a single label. The label is either E2, E3 or E4.
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. To access the patient demographic data entry menu, select NOTE: Select from the real-time display. at any time to go to the real-time display.
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. If user authentication is disabled, the user will still be prompted to enter the device’s Technician password if one has been configured. 1. 2. 3. 4.
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. If user authentication is disabled, the user will still be prompted to enter the device’s Technician password if one has been configured. 1. 2. 3. 4.
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. Once the appropriate selection has been made, select OK.
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. Refer to acquisition module instructions for use. ECG Acquisition ECG data is collected immediately and continuously once the patient is connected to the acquisition module.
RECORD AN ECG ECG Electrode Placement Troubleshooting Please refer to the following troubleshooting guide based on Einthoven’s Triangle: Artifact Check Electrode Possible Solutions Lead II and III artifact Poor LL electrode or left leg tremor Poor RA electrode or right arm tremor Have patient relax tense muscles Lead I and II artifact Lead I and III artifact Poor LA electrode or left arm tremor Any V lead artifact Poor V electrode contact Ensure absence of tension on leadwires Re-prep site(s) and
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.
RECORD AN ECG Printing a Rhythm Strip Begin printing a rhythm strip by selecting . The Rhythm icon is replaced with a Done icon that will stop 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. Rhythm printout settings can be altered during the printout by a touchpad tap in the waveform.
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. 1. 2. 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.
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. When Last10 is selected the device will automatically capture the last ten seconds of ECG from the data stored in the memory buffer.
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. Refer to Configuration Settings for details. Transmitting Records to ELI Link To transmit a record to ELI Link, select Transmit from the acquired ECG view.
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. Select the patient record to be stored to the USB memory stick. Select Transmit. Transferring Batch Patient Records to the USB Memory Stick • • • Place the USB memory stick into the USB host port on the back of the device. Select SYNC.
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. 1. 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. 2. 3.
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. Access requires the user to be logged in as a Technician or Administrator, or to know the device’s Technician password depending on the ELI 380 is configured.
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. Selection of Erase All will prompt the message, Erase All ECGs for this Patient? Select Yes to erase or No to cancel.
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. The Modality Worklist (MWL) directory saves up to 256 pending ECG orders.
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. Patients are displayed with name, ID, location, room number, and date of birth (DOB).
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. broader search can be performed by filling out only one or two of the fields). The ELI 380 is synchronized with a remote server in support of those institutions that would like to perform unordered tests.
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.
CONFIGURATION SETTINGS UTILITY DESCRIPTION CHOICES • • • • • • • • • • • • • • • • • • • • Units for height Units for weight XMT Mandatory Field – ID XMT Mandatory Field – Last Name XMT Mandatory Field – First Name XMT Mandatory Field – DOB XMT Mandatory Field – Tech ID Cart Number Site Number Site Name Encryption Key Sync XMT Sync Patients Sync MWL Sync Date/Time Patient List Comm.
CONFIGURATION SETTINGS Alternate Lead Placement LAN WLAN Password UTILITY Service Presents default settings for 3 alternate lead selections. Set the parameters needed for the Local Area Network. Set the parameters needed for the Wireless Local Area Network. Administrator enters and changes passwords to limit access to the configuration menus, ECG directory, MWL, and Patient List. DESCRIPTION Allows qualified personnel access to Service utilities.
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).
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. Use the up/down arrows to advance to more selections.
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: 1. 2. 3. 4. Select from the real-time ECG display. Select Advanced. Enter your password and select System.
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. Sync MWL: Set to Yes to allow synchronization with the information system MWL orders.
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.
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.
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. Pace Spike Channel: This control allows the user to decide and set whether a pacemaker spike notification marker will display at the base of the ECG printout.
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. NOTE: No copies will automatically print when an ECG is selected from the Full Disclosure history. Copies with Interp.: Allows selection for the number of printed copies containing interpretation when an ECG is taken.
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. Each set lists dropdown selections for each precordial lead, V1 to V6.
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. LED LOCATION STATUS Left LED Dark Left LED Illuminated Right LED Flashing INDICATES ELI 380 is in the Off state. Network link is detected; ELI 380 is On or in Stand-by.
CONFIGURATION SETTINGS Determine WLAN Module Type 1. 2. 3. 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.
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. If WEP wireless security is disabled on your access point, then set security (WEP) to None.
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. • RADIUS User Name • PEM Pass Password EAP-TLS requires client TLS certificates to be installed in the system.
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. IP Address: Allows IT personnel to enter the fixed IP address for network transmission (if DHCP is not selected). Def.
CONFIGURATION SETTINGS • WPA2-EAP-TLS: WPA2 interface with EAP-TLS requires client TLS certificates for authentication. o 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. o RADIUS User Name: The RADIUS user name can be up to 64 alphanumeric characters in length. o PEM Pass Password: The PEM Pass password can contain up to 64 alphanumeric characters in length.
13. MAINTENANCE AND TROUBLESHOOTING System Troubleshooting Chart LCD Message Problem Correction BATTERY LOW – CHARGE UNIT Unable to acquire ECG or unable to print. Lead fail. Charge the battery with AC power. LEAD FAULT, NO ECG CAPTURE Correct faulty lead. Ensure that AMxx or WAM are properly configured. If using the WAM, ensure that the WAM is paired with the ELI 380. None Device is not responding Press and hold the On/Off button for 10 seconds.
MAINTENANCE AND TROUBLESHOOTING Affected Leads ARTIFACT / NOISE on All Leads Problem High Freq. Noise. Correction 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. WARNING: When the 40 Hz filter is used, the frequency response requirement for diagnostic ECG equipment cannot be met.
MAINTENANCE AND TROUBLESHOOTING Transmission Troubleshooting Chart LCD Message Problem Correction TRANSMIT FAILED ERROR-DICOM Not Enabled Unable to transmit ECG. A DICOM communication was attempted, but the unit is not configured for DICOM. Ensure site number is valid. Retry. Configure the system to DICOM and reboot. UNABLE TO SAVE ECG No available memory. Transmit or mark records for deletion in the directory. ECG data too noisy to store. Correct noise and try acquisition/storage again.
MAINTENANCE AND TROUBLESHOOTING Display Troubleshooting Chart LCD Message Problem Correction Screen is dark The AC power cord is not connected to a grounded electrical outlet or is damaged. Ensure that AC power cord is not damaged and is firmly connected to AC power connector on rear of electrocardiograph. Ensure that electrocardiograph is plugged into grounded electrical outlet. Electrocardiograph is in Standby Mode Electrocardiograph will not power on.
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).
14. APPENDIX Loading Certificates on the ELI 380 Before you begin: 1. Create a folder on the USB drive that will be used to load the certificates called “Certificates” 2. Place certificate files into the “Certificates” folder. The ELI 380 will not load the certificates if the folder is not created with files inside. 3. Please note: the TLS user name and password are limited to 63 characters Loading certificates: 1. On the home screen, select Settings (gears icon) 2. Select Advanced 3.
APPENDIX 9. Once a selection has been made, additional options will appear. Enter the appropriate information. a. For WPA2-EAP-TLS, enter: i. RADIUS User Name ii. PEM pass phrase b. For WPA2-EAP-TLS (p12/pfx), enter: i. RADIUS User Name ii.
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. The ELI 380 has default names listed in each field, examples for WPA2-EAP-TLS (p12/pfx) are shown below. 13. Insert the USB drive with the proper certificates into the back of the ELI 380. 14.
APPENDIX 17. 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. In order to transmit ECGs, the WLAN signal must be strong enough to transmit.
