Hillrom Welch Allyn ELI 230 User Manual
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Hillrom Welch Allyn ELI 230 User Manual

12-lead resting electrocardiograph
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Welch Allyn
®
ELI
230
®
12-Lead Resting Electrocardiograph
User Manual
Manufactured by Welch Allyn, Inc. Skaneateles Falls, NY USA
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 230

  • Page 1 Welch Allyn ® ® 12-Lead Resting Electrocardiograph User Manual Manufactured by Welch Allyn, Inc. Skaneateles Falls, NY USA CAUTION Federal law restricts this device to sale by or on the order of a physician.
  • Page 2 Welch Allyn. Welch Allyn and Burdick are registered trademarks of Welch Allyn, Inc. AM12, ELI, VERITAS, and WAM are trademarks of Welch Allyn, Inc. Hillrom™ is a trademark of Hill-Rom Services, Inc. Software V1.3.X.

  • Page 3: Table Of Contents

    Table of contents Notices ............................................... 3 Manufacturer’s responsibility ................................. 3 Responsibility of the customer ................................3 Equipment identification..................................3 Copyright and trademark notices ................................. 4 Other important information .................................. 4 Warranty information ........................................5 Your Welch Allyn warranty ..................................5 User safety information.......................................
  • Page 4 Table of contents Using the WAM (Wireless Acquisition Module) ..........................36 Record an ECG ..........................................37 Patient preparation ....................................37 Patient hookup ......................................37 Patient demographic entry ..................................39 ECG acquisition, printing, storage............................... 39 Acquiring an ECG using the WAM ............................... 42 Acquiring rhythm strips ..................................

  • Page 5: Notices

    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: Copyright And Trademark Notices

    Notices Copyright and trademark notices This document contains information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced, or translated to another language without prior written consent of Welch Allyn, Inc. Other important information The information in this document is subject to change without notice.

  • Page 7: Warranty Information

    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 Warranty information EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST WELCH ALLYN FOR CLAIMS RELATING TO THE PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS NOTICED AND WELCH ALLYN IS NOTIFIED WITHIN THE WARRANTY PERIOD.

  • Page 9: User Safety Information

    User safety information Means there is the possibility of personal injury to you or others. WARNING Means there is the possibility of damage to the device. CAUTION Note: Provides information to further assist in the use of the device. Warnings •...
  • Page 10 User safety information electrodes) must not be reused. To maintain safety and effectiveness, electrodes must not be used beyond their expiration date. • A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture. •...

  • Page 11: Cautions

    User safety information • This product complies with relevant electro-magnetic interference, mechanical safety, performance, and biocompatibility standards. However, the product cannot completely eliminate potential patient or user harm from the following: • Harm or device damage associated with electro-magnetic hazards, •...

  • Page 12: Notes

    User safety information battery from WAM when not used for an extended period of time. • Be careful to insert the connector block into the appropriate input connector by matching the lead wire labels to the WAM or AM12 label. •...
  • Page 13 User safety information with mains. The ground terminal on the mains inlet is the only protective earth point in the device. Exposed metal accessible during normal operation is double insulated from mains. Internal connections to earth ground are functional earth. •...
  • Page 14 User safety information Page | 12...

  • Page 15: Equipment Symbols And Markings

    Equipment symbols and markings Device 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.
  • Page 16 Non-ionizing electromagnetic radiation Follow instructions for use (IFU) -- mandatory action. A copy of the IFU is available on this website. A printed copy of the IFU can be ordered from Hillrom for delivery within 7 calendar days. Medical Device Model Identifier...
  • 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 Contains Non-spillable Battery Page | 15...
  • Page 18 Equipment symbols and markings Page | 16...

  • Page 19: General Care

    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.

  • Page 20: 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 | 18...

  • Page 21: Electromagnetic Compatibility (Emc)

    Electromagnetic compatibility (EMC) Electromagnetic compatibility with surrounding devices should be assessed when using the device. An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic compatibility (EMC) has been performed on the device according to the international standard for EMC for medical devices (IEC 60601-1-2). This IEC standard has been adopted in Europe as the European Norm (EN 60601-1-2).

  • Page 22: Guidance And Manufacturer's Declaration: Electromagnetic Emissions

    Electromagnetic compatibility (EMC) Guidance and manufacturer’s declaration: electromagnetic emissions The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment: Guidance...

  • Page 23: Guidance And Manufacturer's Declaration: Electromagnetic Immunity

    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. Compliance Level IEC 60601 Test Emissions Test...

  • Page 24: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Equipment

    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 25: Introduction

    Introduction Manual purpose This manual is intended to provide the user with information about: • Using and understanding the ELI 230 electrocardiograph, the function keys, and the display screen. • Preparing the ELI 230 for use. • Acquiring, printing, and storing an ECG. •...

  • Page 26: Intended Use

    Introduction Intended use The ELI 230 is a multi-channel electrocardiograph product used for acquiring, viewing and printing resting ECGs. The ELI 230 is a 12-channel diagnostic electrocardiograph intended for recording and printing ECGs of adult and pediatric patients. The device is not intended to be used as a vital signs physiological monitor.

  • Page 27: Eli 230 System Illustration

    Introduction ELI 230 system illustration Figure 1-1 Page | 25...
  • Page 28 Introduction ELI 230 left side Figure 1-2 ELI 230 rear Figure 1-3 Page | 26...
  • Page 29 Introduction ELI 230 base Figure 1-4 Page | 27...

  • Page 30: Eli 230 Display Overview

    Introduction ELI 230 display overview Figure 1-5 Heart Rate Speed Best 10 Gain Filter Clock Function Key Labels Function Keys Function keys Function keys activate the liquid crystal display (LCD) label above each function key. LCD labels/functions change depending upon the screen displayed. If the label is blank, the function key is not active.
  • Page 31 Introduction Rhythm Use RHY to start a rhythm print. Use RHY again to switch to alternate leads. Speed Use MORE followed by SPEED to select display speed or rhythm printout speed: 5 mm/s, 10 mm/s, 25 mm/s, or 50mm/s. Paper speed is printed at the bottom right corner of the ECG printout. NOTE: ECG paper speed is configured in page one of the Configuration menus.

  • Page 32: Eli 230 Specifications

    Introduction ELI 230 specifications Radio specifications and certification information for the Wireless Acquisition Module (WAM) and USB Transceiver Key (UTK), can be found in the WAM user manual. Feature Specification Instrument Type 12-lead electrocardiograph Input Channels Simultaneous acquisition of all 12 leads Standard Leads Acquired I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 Waveform Display...

  • Page 33: Am12 Specifications

    Introduction AM12 specifications Feature Specification* Instrument Type 12-lead ECG acquisition module Input Channels 12-lead signal acquisition ECG Leads Output I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 Trunk Cable Length Approximately 10 feet (3 meters) AM12 Lead Set RA, LA, RL, LL, V1, V2, V3, V4, V5, and V6 (R, L, N, F, C1, C2, C3, C4, C5, and C6) with detachable lead wires...

  • Page 34: Electrodes

    WAM wireless acquisition module with 10 wire AHA lead set with clips 41000-032-52 AM12 acquisition module with AHA Clip Lead Set Electrodes Part Number Description 108070 ECG MONITORING ELECTRODES CASE 300 108071 ELECTRODE RESTING TAB CASE/5000 Contact your distributor or go to hillrom.com for more information. Page | 32...

  • Page 35: Equipment Preparation

    Equipment preparation Connecting the acquisition module Connect the AM12™ to the USB port on the front end of the device. The ELI 230 will automatically convert to the AM12 acquisition module. When using the WAM™ (Wireless Acquisition Module) for ECG acquisition, the connector is not required.

  • Page 36: Loading Paper

    Equipment preparation Loading paper Figure 2-2 Remove the outer packaging from the paper roll. Facing the front of the device, use the release latch on the top side to pull the paper tray cover slightly to the right and lift up to open. NOTE: cover does not come completely off.

  • Page 37: Applying Power

    Equipment preparation Applying power Plug the power cord into an AC wall outlet and into the back of the ELI 230. (Reference Figure 1- 3.) Device powers on automatically and cannot be turned off when AC is connected (device can be put into standby mode).

  • Page 38: Setting Date And Time

    Equipment preparation Setting date and time Select MORE from real-time ECG view. Select CONFIG. Select 3 Set Time/Date. The preprogrammed date and time is displayed. To make changes to the date and time values (using a 24- hour clock) in the same format as displayed, use ▲ and ▼ to move back and forth through each row.

  • Page 39: Record An Ecg

    Record an ECG Patient preparation Before attaching the electrodes, assure the patient fully understands the procedure and what to expect. • Privacy is very important in assuring the patient is relaxed. • Reassure the patient that the procedure is painless and that the electrodes on their skin are all that they will feel.
  • Page 40 Record an ECG For accurate V-lead placement and monitoring, it is important to locate the 4 intercostal space. The 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 41: Patient Demographic Entry

    Record an ECG Patient demographic entry Patient demographic information can be entered before acquisition only if the patient is connected to the ELI 230. The entered patient ID fields will remain populated until you acquire the ECG; however, if you disconnect the leads from the patient, turn off the electrocardiograph, or change a configuration setting before acquisition, the patient information will be cleared.
  • Page 42 Record an ECG 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 Patient Preparation satisfactory waveform(s). (See •...
  • Page 43 Record an ECG Best 10 seconds selection The ELI 230 incorporates a one-minute memory buffer for collection of ECG data. When the Best 10 feature is enabled, the device will automatically select the best 10 seconds of ECG from within the one-minute buffer.

  • Page 44: Acquiring An Ecg Using The Wam

    Record an ECG Acquiring an ECG using the WAM Use the LED indicators to check electrode-to skin impedance and verify patient hookup quality, as well as to ensure communication has been established with the electrocardiograph and the signal quality of each ECG is transmitted as expected. A yellow LED indicates a lead fail condition. Ensure an AA battery is in the battery compartment.

  • Page 45: Transfer To A Usb Memory Stick

    Record an ECG V4-V5-V6 During 6-channel rhythm printing, the available lead groups are: Default (user-selected in configuration) I-II-III-aVR-aVL-aVF V1-V2-V3-V4-V5-V6 During rhythm printing the user can place the writer in Standby mode by pressing STOP. To continue rhythm printing for the same patient without advancing to a new page, select RHY. Transfer to a USB memory stick The user can transfer all the ECG records from the ELI 230 to an external USB memory stick at any time.
  • Page 46 Record an ECG Page | 44...

  • Page 47: System Settings

    System settings Accessing configuration menus The configuration pages define all operational conditions that do not change on a daily or patient-to- patient basis. Once you set these default conditions, you will rarely need to use the configuration screens again. To access the configuration menus: Select MORE from real-time ECG view.

  • Page 48: Summary Of Configuration Menus

    System settings The following chart summarizes the configuration parameters and the available options for each field. Summary of configuration menus Configuration Parameter Definition Software Version Displays software version on printout and in configuration menu Language Software language availability Battery Timeout 10, 20, or 30 minutes Time Mode 12 hour or 24-hour clock...

  • Page 49: Configuration Settings

    System settings Configuration settings Software version Identifies the software version of your electrocardiograph. Language There are several languages available on the ELI 230 electrocardiograph. CAUTION Function labels are immediately translated upon selecting a new language and exiting the configuration menu. If an unknown language is visible, use the following steps to revert to the language of your country: From real-time ECG view, select MORE.
  • Page 50 System settings Filter The ECG plot-frequency filter (or print filter) can be set to 40 Hz, 150 Hz, or 300 Hz. The plot-frequency filter does not filter the acquired digital record. A 40 Hz plot-filter setting will reduce the noise (40 Hz and higher frequencies) on the printed ECG, and a 150 Hz plot-filter setting will reduce the noise (150 Hz and higher frequencies) on the printout;...
  • Page 51 System settings Auto-print ECG Defines whether or not the ELI 230 will automatically print the ECG after acquisition. If the selected configuration option is set to No, a manual printout is possible. Display format Defines the default display format in either 4+4 or 6+6. Regardless of the display format selected, 10 seconds of 12 leads are always acquired.
  • Page 52 System settings ECG capture Up to one minute accumulated ECG data can be acquired internally for use with the Best 10 feature. The device automatically selects the best 10 seconds from within the one-minute buffer. Users can switch between BEST 10 or LAST 10 by selecting BEST10 or LAST10 from acquired ECG view.

  • Page 53: Maintenance And Troubleshooting

    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 or noisy ECG data. Correct faulty lead or noise.

  • Page 54: Recommendations To Biomedical Staff

    MAINTENANCE AND TROUBLESHOOTING Recommendations to biomedical staff Following any service to the ELI 230 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) •...

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