Welch Allyn® ELI® 150c/ ELI® 250c 12-Lead 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.
© 2020 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., E-Scribe, ELI, and VERITAS are trademarks of Welch Allyn, Inc., Cisco® is the registered trademark of Cisco Systems, Inc.
TABLE OF CONTENTS NOTICES ..................................................................................................................................................................... 5 MANUFACTURER’S RESPONSIBILITY ............................................................................................................................................ 5 RESPONSIBILITY OF THE CUSTOMER ..................................................................................................................
TABLE OF CONTENTS EQUIPMENT PREPARATION .......................................................................................................................................49 INITIAL STARTUP ................................................................................................................................................................... 49 CONNECTING THE ACQUISITION MODULE ....................................................................................................................
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.
WARRANTY INFORMATION Your Welch Allyn Warranty WELCH ALLYN, INC., (hereinafter referred to as “Welch Allyn”) hereby warrants that Welch Allyn products (hereinafter referred to as “Product/s”) shall be free from defects in material and workmanship under normal use, service, and maintenance for the warranty period of such Product/s from Welch Allyn or an authorized distributor or representative of Welch Allyn.
WARRANTY INFORMATION 8
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. WARNING(S) • This manual gives important information about the use and safety of this device.
USER SAFETY INFORMATION 10 • A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture. • Where the integrity of external protective earth conductor arrangement is in doubt, the device shall be operated from its internal electrical power source.
USER SAFETY INFORMATION • The quality of the signal produced by the device may be adversely affected by the use of other medical equipment, including but not limited to defibrillators and ultrasound machines. • For proper operation and the safety of users or patients and bystanders, equipment and accessories must be connected only as described in this manual. Do not connect a telephone line cable to the LAN connector.
USER SAFETY INFORMATION • • This product complies with relevant electro-magnetic interference, mechanical safety, performance, and biocompatibility standards.
USER SAFETY INFORMATION • A square wave presentation on the display while using the WAM may be due to the WAM being turned off, having no battery, not being paired correctly, operating out of range, or due to a calibration error. Review the LED indicator on the WAM to ensure the unit is turned on, has proper battery level, is paired correctly, and is within recommended proximity of the electrocardiograph, or power cycle the WAM to recalibrate.
USER SAFETY INFORMATION • The device is a member of the ELI 1xx or ELI 2xx Series 2 electrocardiograph family. Wireless Data Transmission • 14 Some Welch Allyn electrocardiographs can be equipped with an optional wireless data transmission module (WLAN or GPRS mobile). Both these technologies use radios to transmit data to a Welch Allyn receiving application.
USER SAFETY INFORMATION WLAN Option • Wireless options transmit at 2.4 GHz. Other nearby wireless devices may cause interference. If possible, move or turn off other devices to minimize potential interference. • The following table shows the channels allocated in different geographic areas in the world. Please consult with your IT personnel in order to set the device on the proper channels. Specification Description Technology IEEE 802.11 b/g, WiFi compliant 2.400 – 2.4835 GHz (U.S.
USER SAFETY INFORMATION 16
EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation CAUTION The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data. 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.
EQUIPMENT SYMBOLS AND MARKINGS Indicates compliance to applicable European Union directives CE symbol UL approved mark Do not re-use, Single use device 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.
EQUIPMENT SYMBOLS AND MARKINGS Use by date Prescription only or "For Use by or on the order of a licensed medical professional Australian Communications and Media Authority (ACMA) Radio Compliance Mark KC Mark (South korea) Radio approval symbol for Pakistan Conatel Approval symbol for Paraguay Eurasia Certification 19
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 20
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. • 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.
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 COMPATIBILTY (EMC) ELI 150c 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) ELI 150c 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 COMPATIBILTY (EMC) ELI 150c 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 250c 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 COMPATIBILTY (EMC) ELI 250c 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 250c 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 COMPATIBILTY (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 COMPATIBILTY (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 par 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 COMPATIBILTY (EMC) Radio Compliance Table Argentina Australia Brazil Ente Nacional de las Comunicaciones (ENACOM) C-22663 (B&B) Australian Communications and Media Authority (ACMA) Radio Compliance Mark (RCM). Agência Nacional de Telecomunicações (ANATEL) Modelo: B&B 02432-19-10488 EAC Indonesia Mexico Keterangan a. [61733/I/SDPPI/2019] (B&B) adalah nomor sertifikat yang diterbitkan untuk setiap alat dan perangkat telekomunikasi b.
ELECTROMAGNETIC COMPATIBILITY (EMC) Philippines National Telecommunications Commission Singapore Info-Communications Media Development Authority (IMDA) South Korea Korea Communications Commission (대한민 국 방송통 신위원 회) – KCC Certification number: B&B: R-C-BVT-9373 B&B: ESD - 1818097C This equipment is Industrial (Class A) electromagnetic wave suitability equipment and seller or user should take notice of it, and this equipment is to be used in the places except for home.
ELECTROMAGNETIC COMPATIBILTY (EMC) 36
INTRODUCTION SECTION 1 Manual Purpose This manual is intended to provide the user with information about: • Using and understanding the ELI™ 150c or ELI 250c electrocardiograph, the function and feature keys, and the display screen. • Preparing the device for use. (Section 2) • Acquiring, printing, and storing an ECG. (Section 3) • System settings. (Section 4) • Connectivity and transmitting ECGs. (Appendix A) • Maintenance and troubleshooting. (Appendix B) NOTE: This manual may contain screen shots.
SECTION 1 The device includes: • Acquisition module with lead wire set • Hospital-grade power cord • Antenna (with WLAN or GPRS mobile) • 1 pack paper • 1 package of electrodes • Physicians Guide Adult & Pediatric (with interpretation feature) • User manual CD • Accessory starter kit Intended Use (Functional Purpose) The ELI 150c or ELI 250c is intended to be a high-performance, 12-lead, multifunctional electrocardiograph.
SECTION 1 System Illustrations* *ELI 250c shown Figure 1-1 Figure 1-2, Left Side 39
SECTION 1 Figure 1-3, Rear Figure 1-4, Base 40
SECTION 1 Display and Keyboard* *ELI 250c shown Figure 1-5 Automatic Feature Keys Automatic feature keys are used as a one-touch operation for: ECG Acquisition Rhythm Printing Transmit and/or Download Order List; Time Sync Stop 41
SECTION 1 Display Overview The device features a ¼ VGA 320 x 240 pixels LCD color display for valuable preview of ECG waveform, function key labels, and other parameters as explained below. During ECG acquisition, notification messages will also appear on the display. (See Section 3, ECG Acquisition, Printing, Storage.) Figure 1-6 Heart Rate (HR): When a patient is connected to the electrocardiograph, his/her HR is displayed in real time.
SECTION 1 Function Keys: Function keys activate the LCD label adjacent to each function key. LCD labels/functions change depending upon the screen displayed. If the label is blank, the function key is not active. Battery Indicator: Indicates available battery power. (See Section 2, Applying Power.) Acquisition Module: Displays type of acquisition module being used. Clock: Time display with hour, minutes, and seconds resolution. (See Section 2 for setting a new time and date.
SECTION 1 ELI 150c Specifications WAM / UTK Radio specifications and certification information for the Wireless Acquisition Module (WAM) and USB Transceiver Key (UTK), can be found in the WAM user manual.
SECTION 1 ELI 250c Specifications Feature Specifications 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 Backlit, ¼ VGA color LCD (320 x 240); 3, 4+4, or 6+6 lead presentation Meets or exceeds requirements of ANSI/AAMI/IEC 60601-2-25 Input Impedance Input Dynamic Range Electrode Offset Tolerance Common Mode Rejection Pacemaker Pulse Display Patient Leakage
SECTION 1 AM12 Specifications Feature Specification* Instrument Type 12-lead ECG acquisition module for cardiac stress testing 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 Sampling Rate 40,000 samples/second/channel acquisition; 1,000 samples/second/cha
SECTION 1 Accessories Replacement Lead sets and Accessories Part Number Description 9293-046-07 COMBINER WAM LEADS 10 POS IEC & AHA GRAY 9293-046-60 LEAD SET WAM 10 WIRE BANANA AHA GRAY 9293-046-61 LEAD SET WAM 10 WIRE BANANA IEC GRAY 9293-046-62 RPLCE LD SET WAM/AM12 LIMBS BANA AHA GRY 9293-046-63 RPLCE LD SET WAM/AM12 LIMBS BANA IEC GRY 9293-046-64 RPLCE LD SET WAM/AM12 V1-V3 BANA AHA GRY 9293-046-65 RPLCE LD SET WAM/AM12 C1-C3 BANA IEC GRY 9293-046-66 RPLCE LD SET WAM/AM12 V4-V6 BANA AH
SECTION 1 Acquisition Modules Part Number 9293-048-54 30012-019-55 30012-019-56 Description WIRED PATIENT CABLE (AM12) W/O LEADWIRES WIRELESS ACQUISITION MODULE (WAM) W/O LEAD WIRES Version 1 Note, prior to ordering reference section Important Version Information for WAM (Wireless Acquisition Module). WIRELESS ACQUISITION MODULE (WAM) W/O LEAD WIRES Version 2 Note, prior to ordering reference section Important Version Information for WAM (Wireless Acquisition Module).
EQUIPMENT PREPARATION SECTION 2 Initial Startup With its initial use, the device requires the user to set certain configurations prior to obtaining any ECGs. The device will automatically display a language configuration page followed by AC filter frequency, height/weight units, a set time/date configuration page (including daylight savings time selection), and a configuration page to pair the WAM™ (wireless acquisition module) if it will be used.
SECTION 2 Loading Paper Figure 2-2 1. Remove all packaging including cardboard backing from the paper stack. 2. Facing the front of the device, use the release latch on the left side and slide the paper tray cover to the left. 3. 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. 4.
SECTION 2 A4 Paper Use with The ELI 250c If the ELI 250c was ordered with A4 paper, the paper tray spacer will be inserted in the paper tray and the configuration option to use A4 paper will be set to YES. A paper tray spacer will not be provided if the device was purchased with standard paper. To insert the paper tray spacer: Figure 2-3 1. Slide paper tray spacer towards rear wall of writer tray. Align the bottom four plastic arms with the four openings in the base of the writer tray.
SECTION 2 Figure 2-4 2. The paper tray spacer should be parallel with the rear wall of the writer tray. Figure 2-5 3. Gently press paper tray spacer in place. 4. Set configuration option to use A4 paper. (See Section 4.) 5. 52 Gently press on the top three plastic arms to remove the paper tray spacer.
SECTION 2 Applying Power 1. Plug the power cord into an AC wall outlet and into the back of the device. (Reference Figure 1-3.) 2. Press the power ON/OFF button located on the face panel of the device. (Reference Figure 1-5.) When using AC power, the battery indicator is clear when charging and illuminates in white when fully charged. When using battery power, the battery indicator illuminates in green with a 35% to 100% charge and in yellow with a 20% to 35% charge.
SECTION 2 Log-In Screen When the Log-In Authentication mode is enabled (see Systems Settings section), and the device is powered on or comes out of standby mode, a username/password prompt will display. If the Log-In Authentication is not enabled (default setting), the device will proceed to the real-time ECG view.
SECTION 2 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. A number 2 circular label on the back housing of the ELI electrocardiograph located next to the ECG input connector indicates the electrocardiograph internally contains a version 2 UTK.
SECTION 2 Important note regarding WAM connectivity A version 1 WAM must be used with a version 1 UTK, and a version 2 WAM must be used with a version 2 UTK. If the version of WAM does not match the version of UTK that is within the ELI electrocardiograph, the WAM will not pair to the electrocardiograph and a “SEARCHING FOR WAM” message will continue to be displayed. When using the WAM, it must be successfully paired to the electrocardiograph before operation.
RECORD AN ECG SECTION 3 Patient Preparation Before attaching the electrodes, assure the patient fully understands the procedure and what to expect. • Privacy is very important in assuring the patient is relaxed. • Reassure the patient that the procedure is painless and that the electrodes on their skin are all that they will feel. • 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.
SECTION 3 For accurate V-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.
SECTION 3 Patient Demographic Entry Patient demographic information can be entered before acquisition. 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. To access the patient demographic data entry menu, press F1 (ID) from real-time ECG view.
SECTION 3 Entering Symbols Punctuation characters, symbols, and/or accented alphanumeric characters (language dependent) can be entered using the SYM key on the keyboard. Selecting SYM will display 10 special characters at a time. Use F1 (Prev) or F2 (Next) to move to the previous/next set of special characters. Each special character will have a numeric character located below it. Using the keyboard, press the desired numeric key to add the corresponding special character.
SECTION 3 NOTE: The algorithm detecting electrode misplacements is based on normal physiology and ECG lead order, and tries to identify the most likely switch; however, it is advisable to check the other electrode positions in the same group (limb or chest). • • WAM Low Battery – displays when a low battery signal for the WAM is detected. Searching for WAM – displays when the WAM is not detected. Occurs usually when the WAM is out of range or not powered on.
SECTION 3 Printing If Auto-Print is enabled in the configuration, an ECG is printed following acquisition. To print a manual printout, select F3 (Print). Toggle through the available waveform display formats (3, 8 or 12 lead) by selecting F2 (Leads). A preview of the full 10-seconds of ECG waveform is available in the acquired ECG view.
SECTION 3 During 3-channel rhythm printing, the available lead groups are: 1. Default (user-selected in configuration) 2. I-II-III 3. aVR, aVL, aVF 4. V1-V2-V3 5. V4-V5-V6 During 6-channel rhythm printing, the available lead groups are: 1. Default (user-selected in configuration) 2. I-II-III-aVR-aVL-aVF 3. V1-V2-V3-V4-V5-V6 During 12-channel rhythm printing (ELI 250c only), the complete 12 leads are printed simultaneously. During rhythm printing, place the printer in Standby mode by pressing F6 (Stby).
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SYSTEM SETTINGS SECTION 4 Configuring Users and Roles Options for configuring users and roles depends on whether Log-In Authentication is set to ON or OFF in Configuration Settings. If Log-In Authentication is OFF, three generic roles, Technician, Site Admin, and Admin, can be activated to manage access to specific device features.. If Log-In Authentication is ON, up to 30 unique users can be configured for the device. The default device setting has Log-In Authentication set to OFF, and no active roles.
SECTION 4 Feature Patient Information Type in Patient Information Select Patient Information from Orders List Select Patient Information from Patient List (Directory) ECG Capture Accept ECG Reject ECG Print ECG Transmit ECG Edit ECG ECG Directory View an ECG Print an ECG Transmit an ECG Edit an ECG Delete an ECG Sync Custom ID Download Orders / MWL Download Date & Time Sync Real-Time Sync (Network) Real-Time Sync (USB) Settings Settings Screens Software Version ECG Storage Manage Passwords Date/Time Time Z
SECTION 4 Configuring Users when Log-In Authentication is ON 1. From real-time ECG view, select F6 (More) followed by F5 (Set Time/Date). 2. 3. While holding down • (SHIFT), depress ALT and P simultaneously. If required, enter the admin password. This will automatically advance you to the User List. NOTE: The factory default password is “admin” (lowercase, no quotation marks); it is suggested that the password be changed after installation of the unit. The User List displays one user per page.
SECTION 4 Feature Patient Information Type in Patient Information Select Patient Information from Orders List Select Patient Information from Patient List (Directory) ECG Capture Accept ECG Reject ECG Print ECG Transmit ECG Edit ECG ECG Directory View an ECG Print an ECG Transmit an ECG Edit an ECG Delete an ECG Sync Custom ID Download Orders / MWL Download Date & Time Sync Real-Time Sync (Network) Real-Time Sync (USB) Settings Settings Screens Software Version ECG Storage Manage Users List Date/Time Time
SECTION 4 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: 1. 2. 3. From real-time ECG view, select F6 (More) followed by F5 (Set Time/Date). While holding down • (SHIFT), depress ALT and C simultaneously. Using the keyboard, enter “admin” (lowercase, no quotation marks).
SECTION 4 Summary of Configuration Menus Configuration Parameter 70 Definition Software Version Displays software version on printout and display Cart Number Numeric field 0 to 65535 Site Number Numeric field 0 to 8191 Site Name Alphanumerical field (30 digits) Telephone Number Alphanumerical field (45 digits) Language Available software languages Volume Numerical field 0 to 8 Battery Timeout 10 min, 30 min, 60 min ECG Storage Normal or expanded (optional) — configured at time of purcha
SECTION 4 Summary of Configuration Menus (continued) Configuration Parameter Definition 6 Rhythm Lead 2 V1-V6, I, II, III, aVR, aVL, aVF 6 Rhythm Lead 3 V1-V6, I, II, III, aVR, aVL, aVF 6 Rhythm Lead 4 V1-V6, I, II, III, aVR, aVL, aVF 6 Rhythm Lead 5 V1-V6, I, II, III, aVR, aVL, aVF 6 Rhythm Lead 6 V1-V6, I, II, III, aVR, aVL, aVF Plot Format 3, 3+1, 3+3, 6 channel; Cabrera or standard (ELI 150c) 3+1, 3+3, 6, 6+6, 12 channel; Cabrera or standard (ELI 250c) 3+1 Rhythm Lead V1-V6, I, II, III
SECTION 4 Summary of Configuration Menus 72 (continued) Configuration Parameter Definition WEP Key Numeric (1 digit) (not on printout); valid range 1-4 WEP Key ID Alphanumerical field (26 digits) A-F, 0-9 (not on printout) PSK Passphrase Alphanumeric field (64 digits) (not on printout) LEAP User Name Alphanumeric field (32 digits) (not on printout) LEAP Password Alphanumeric field (32 digits) (not on printout) PEAP User Name Alphanumeric field (63 digits) (not on printout) PEAP Password A
SECTION 4 Configuration Settings Software Version Identifies the software version of your electrocardiograph. Cart Number Indicates which electrocardiograph acquired or transmitted a particular ECG. Site Number Identifies the site of your device. Site numbers designate the hospital, clinic, or institution for ECG records stored in an E-Scribe system and must be defined for transmitting and retrieving ECGs from that system. You can use up to four digits for the site number.
SECTION 4 If an unknown language is visible, use the following steps to revert to the language of your country: 1. 2. 3. 4. 5. 6. 7. F6 (More) from real-time ECG view. Select F5 (Set Time/Date). Simultaneously press (SHIFT) + ALT + C. Enter password (“admin”) Press F2 (▼) four times. Press F3 (►) until the desired language appears. F6 (Exit) to return to real-time ECG view. Alphabets of specific languages may require use of special characters in demographic fields.
SECTION 4 AC Filter The device removes 60 Hz or 50 Hz interference. The setting you select depends on the line frequency in your country. Always use the 60 Hz setting in the U.S. If AC interference is present, check to see that the proper AC filter is selected. Paper Speed Configure to 25 mm/s or 50 mm/s for default ECG printouts. For rhythm printouts and display, speeds of 5 mm/s or 10 mm/s are also available. See Section 3 to change speeds for display or rhythm printing.
SECTION 4 Number of Copies Defines the number of printed copies when an ECG is taken. A zero (0) setting prints no ECG; one (1) prints the original; two (2) prints the original plus 1 copy, and so on. Up to 9 copies may be selected. Copies with Interpretation Defines whether or not printed copies will include interpretation. The clinician may request the first ECG printout with the interpretation included. Additional copies may be printed with or without the interpretation.
SECTION 4 Rhythm Formats Defines the default values for rhythm printing. It is possible to set a 3 or 6-channel default rhythm format for the ELI 150c. For the ELI 250c, a 3, 6, or 12-channel default rhythm format is possible. Define rhythm leads one through three to customize a 3-channel rhythm printout or define rhythm leads one through six to customize the 6-channel rhythm printout. Plot Format Defines the default for one of the available plot formats in either standard or Cabrera presentation.
SECTION 4 Rhythm Leads Displays continuous rhythm of selected ECG leads and permits printing of selected leads. User may toggle between selected leads, system set leads, or I, II, III, aVR, aVL, and aVF followed by V1, V2, V3, V4, V5, and V6. NOTE: Rhythm acquisition is not stored in memory, only printed. NOTE: See Section 3 to acquire a rhythm printout. Bar Code Scanner Enabling this option will allow for the use of a Welch Allyn approved USB bar code scanner.
SECTION 4 DHCP Defines 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, you must enter the IP address, def gateway, and sub net mask. NOTE: All parameters related to network connection must be entered under the direction of the IT Manager of the facility where the device is installed. See Appendix A for more information on device connectivity settings.
SECTION 4 WLAN MAC Shows the MAC address of the device’s wireless module for configuring access points. SSID Service Set Identifier (SSID) is the name of the wireless network. All ELI 150c electrocardiographs that will transmit to the same network must have the same SSID name. This field is case sensitive. WPA-PSK/WPA2-PSK Allows for implementation of the “personal mode” of WPA. This mode of encryption employs Temporal Key Integrity Protocol (TKIP) which dynamically changes keys as the system is used.
SECTION 4 Access Point Password Access Point Password can be up to 120 characters in length. Comm. Protocol Select UNIPRO OR DICOM. DICOM is only available if the DICOM option has been installed. NOTE: This parameter must be entered under the direction of the IT Manager of the facility where the device is installed. NOTE: Units ship by default with Comm. Protocol set to UNIPRO or DICOM. The UNIPRO or DICOM setting is not supported by E-Scribe or ELI Link versions prior to V4.00.
SECTION 4 ACTION Startup Shutdown Audit Trail Cleared Log-in success Log-in failure Log out Unknown Guest Entered Password Entered Directory list viewing New ECG Patient Demographics Entry (Create ID) ECG capture ECG Save ECG deletion ECG edit (patient demographics) ECG print ECG transmission Individual ECG viewing Orders list viewing Order selection Orders download Rhythm print User list viewing User add User delete User edit Date/Time change Other settings change Audit trail export Software Update Softw
SECTION 4 File Encryption and Key When the File Encryption setting is set to ON, all record and order files will be encrypted using the File Encryption Key. When the File Encryption setting is changed to OFF, all record and order files will be decrypted. The Audit Trail, configuration and User List files are always encrypted using the File Encryption Key independent of the File Encryption configuration setting. The File Encryption key is editable by the administrator.
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ECG DIRECTORY SECTION 5 The standard ECG directory saves up to 40 individual ECG records. The optional expanded memory permits up to 200 individual ECG records. To access the ECG directory, select F6 (More) followed by F1 (Directory of Stored ECGs) from the real-time ECG view. NOTE: A password may be required in order to enter the ECG directory. Obtain the password from the department Administrator.
SECTION 5 ECG Order List To display the ECG order list, select F4 (Order) from the patient ID screen. The ECG order list is comparable to the ECG directory in looks and in practice; you can sort the list by name, ID, or date.
CONNECTIVITY AND ECG TRANSMISSION APPENDIX A ECG Transmission You may transmit ECGs to ELI Link, or to a third party EMR using an optional factory installed internal modem, LAN, WLAN, or optional integrated GPRS mobile connection (GPRS option applies to ELI 150c only): all the mentioned transmission modes can use the Welch Allyn UNIPRO or DICOM communication protocol. NOTE: Units ship by default with Comm Protocol set to UNIPRO. The UNIPRO setting is not supported by E-Scribe versions prior to V8.
APPENDIX A Modem Transmission For a modem transmission, set the Sync media to modem. Connect the device to a standard telephone jack with the provided phone line cable. Plug the cable into the telephone jack located on the back of the device and the other end into a telephone wall jack. Confirm telephone number in the configuration settings. CAUTION: Use only No. 26 AWG or larger telecommunication line cord. Modem Initialization The modem initialization string is country specific.
APPENDIX A Modem Country Code List Country Code Country Code Afghanistan Albania Algeria American Samoa Andorra Angola Anguilla Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bosnia and Herzegovina Botswana Brazil Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Georgia Germany Ghana 34 34 34 34 34 34 34 34 34 34 34 1 34 34 34 34 34 34 34 34 34 34 34 34 34 34 34 34
APPENDIX A 90 Country Code Country Code Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey, C.I. Guinea Guinea-Bissau Guyana Haiti Holy See (Vatican City State) Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey C.I.
APPENDIX A Country Code Country Code Panama Papua New Guinea Paraguay Peru Philippines Poland Portugal Puerto Rico Qatar Reunion Romania Russian Federation Rwanda Saint Kitts and Nevis Saint Lucia Saint Vincent and the Grenadines Samoa Saudi Arabia Senegal Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands South Africa Spain Sri Lanka Sudan Surinam 34 34 34 34 30 30 34 34 34 34 34 34 34 34 34 34 34 34 34 34 34 30 34 30 34 35 34 34 34 34 Tanzania, United Republic of Thailand Thaiti To
APPENDIX A LAN Transmission For a LAN transmission, connect the ethernet cable to the LAN connection at the rear of the device and set the Sync media to LAN in the configuration. It is necessary that the IT Manager of your facility set the device’s LAN configuration values. NOTE: Addresses are always entered as 4 sets of 3 digits; therefore, an address of 192.168.0.7 must be entered on the device as 192.168.000.007.
APPENDIX A If your wireless security environment is WPA or WPA2 (Wi-fi Protected Access) then you will need to enter: Security: WPA-PSK or WPA2-PSK Passphrase: NOTE: The passphrase length is limited to 64 characters. If your wireless security environment is LEAP then you will need to enter: Security: WPA-LEAP LEAP User Name LEAP Password NOTE: LEAP user name and password are limited to 32 characters.
APPENDIX A WLAN Transmission For a WLAN transmission, set the Sync media to WLAN. It is necessary that the IT Manager of your facility configure the wireless access point(s) and E-Scribe workstation. It is also required that your IT Manager provide the device’s WLAN configuration values. The device can be configured for Dynamic Host Communication Protocol (DHCP) or static IP. Wireless security encryption options include WEP, WPA, WPA2, LEAP, and PEAP.
APPENDIX A If your wireless security environment is LEAP then you will need to enter: Security: WPA-LEAP LEAP User Name LEAP Password NOTE: LEAP user name and password are limited to 32 characters. If your wireless security environment is PEAP then you will need to enter: Security: WPA2-PEAP PEAP User Name PEAP Password NOTE: PEAP user name and password are limited to 63 characters. NOTE: When saving the WLAN configuration, the device may require several seconds to complete the saving procedure.
APPENDIX A SIM Card Installation Power off the ELI 150c. Open the printer cover and remove the pack of thermal paper. There is a small access panel on the floor of the paper tray. Remove the screw and lift off the access panel. Using your finger, slide the SIM card socket towards the back of the unit (follow the arrow printed on the circuit board to the “open position”). Again, using your finger, lift the socket upright.
APPENDIX A Custom ID Download Custom ID formats are uniquely defined by your facility’s needs. This customized ECG header information is designed in ELI Link and downloaded to the device. From real-time ECG view, select F6 (More) followed by F2 (Custom ID Download). “Transmission Status” will remain visible for approximately 10 seconds followed by “Waiting for Response”, “Connected”, and “Custom ID downloaded”. A return to the real-time ECG view indicates the custom ID download is complete.
APPENDIX A 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. • Select F1 (Batch). Transmission using the optional USBD (device) port to a PC The optional USBD port permits transmission of stored patient records to a PC using a direct USB cable. The patient records will be transmitted to an ELI Link application (requires V3.
APPENDIX A Network Test Network test sends a command to the server to verify there is a network connection. The status will display for the clinician to review. The test information is also placed into the Log File for review. To view the log type select F6 (More) from the real-time display, followed by F4 (Network Test). When test is completed, select either F3 (Log) to review the log files or F6 (Exit).
APPENDIX A 100
MAINTENANCE AND TROUBLESHOOTING APPENDIX B System Troubleshooting Chart LCD Message Problem Correction BATTERY LOW – CHARGE UNIT Charge the battery with AC power. LEAD FAULT, NO ECG CAPTURE Unable to acquire ECG or unable to print. Lead fail. NO ANSWER Unable to transmit ECG. Check for correct phone number. Ensure modem and E-SCRIBE are online. Press and hold the On/Off button for 10 seconds. Re-entry of date and time will be required after this function.
APPENDIX B Transmission Troubleshooting Chart LCD Message Problem Correction Log File Contact Technical Support UNABLE TO SAVE ORDER Any of the above information will be presented in the Log File A link to the access point was established, but the link to the destination failed. Possible incorrect version of ELI Link or E-Scribe. Order storage failed. UNABLE TO SAVE WORK ITEM DICOM order storage failed. INCORRECT RESPONSE Connection established, then failed. Received orders failed.
APPENDIX B Power Off the Device To completely shutdown the device, disconnect the AC power cord then press the ON/OFF button. Such a shutdown should always be performed prior to authorized repair of the device. Test Operation After cleaning and inspecting the device, proper operation of the unit may be confirmed by using an ECG simulator to acquire and print a standard 12-lead ECG of known amplitude. Printing should be dark and even across the page.
APPENDIX B Cleaning the Thermal Printer To clean the printer 1. Disconnect the power source. 2. Clean the exterior surface of the unit with a damp cloth using a solution of mild dishwashing detergent diluted in water. 3. After washing, thoroughly dry off the unit with a clean, soft cloth or paper towel. To clean the print head NOTE: Do not let soap or water come into contact with the writer, plugs, jacks, or vents. 104 1. Open writer door. 2. Lightly rub print head with an alcohol pad. 3.
