Mortara ELI 380 User Manual Download

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TABLE OF CONTENTS

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REF 9515-189-50-ENG Rev G1

ELI 380

RESTING ELECTROCARDIOGRAPH

USER MANUAL

CAUTION:

Federal law restricts this device to sale by or on the order of a physician

Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A.

Summary of Contents for ELI 380

Page 1: ...REF 9515 189 50 ENG Rev G1 ELI 380 RESTINGELECTROCARDIOGRAPH USER MANUAL CAUTION Federal law restricts this device to sale by or on the order of a physician Manufactured by Mortara Instrument Inc Milw...

Page 2: ...reproduced used or disclosed outside of the receiving organization without the express written consent of Mortara Instrument Inc Mortara is a registered trademark of Mortara Instrument Inc AM12 ELI V...

Page 3: ...PRECAUTIONS 11 INSPECTION 11 CLEANING LEAD WIRES AND CABLES PATIENT ACQUISITION DEVICE AND ELECTROCARDIOGRAPH 11 7 ELECTROMAGNETIC COMPATIBILITY EMC 13 GUIDANCE AND MANUFACTURER S DECLARATION ELECTRO...

Page 4: ...AN ECG 37 PATIENT PREPARATION 37 Preparing Patient Skin 37 PATIENT HOOKUP 37 To Attach the Electrodes 37 Alternate 12 Lead Placement 40 PATIENT DEMOGRAPHIC ENTRY 41 Patient Demographic Formats 41 Man...

Page 5: ...ORDERS 57 SYNCHRONIZE FUNCTION 57 MWL QUERY CODE FUNCTION 57 SEARCHING ECG ORDERS 57 PATIENT LIST 59 SEARCHING THE PATIENT LIST 59 PRINTING THE ECG DIRECTORY MWL ORDERS OR THE PATIENT LIST 59 13 CONFI...

Page 6: ...RANSMISSION TROUBLESHOOTING CHART 78 DISPLAY TROUBLESHOOTING CHART 80 REBOOT THE DEVICE 81 TEST OPERATION 81 RECOMMENDATIONS TO BIOMEDICAL STAFF 81 CLEANING THE THERMAL PRINTER 81 To Clean the Printer...

Page 7: ...Figure 3 ELI 380 Rear with Connector Ports 24 Figure 4 ELI 380 Base with Battery Compartment 24 Figure 5 ELI 380 Keyboard 25 Figure 6 Optional ELI 380 Touchscreen Figure 7 ELI 380 Home Display with Fu...

Page 8: ...TABLE OF FIGURES...

Page 9: ...53224 U S A Tel 414 354 1600 Fax 414 354 4760 Hospital Customers orders us mortara com Physician Practice orderspc us mortara com U S Distribution orderspc us mortara com Mortara Instrument Germany B...

Page 10: ...functionality and integrity Equipment Identification Mortara Instrument Inc equipment is identified by a serial and reference number on the bottom of the device Care should be taken so that these num...

Page 11: ...aster affecting the Product s e Alterations and or modifications to the Product s not authorized by Mortara f Other events outside of Mortara s reasonable control or not arising under normal operating...

Page 12: ...OTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD IN NO EVENT INCLUDING THE CLAIM FOR NEGLIGENCE SHALL MORTARA BE LIABLE FOR INCIDENTAL SPECIAL OR CONSEQUENTIAL DAMAGES OR FOR ANY OTHER LOSS D...

Page 13: ...ying documents Inadequate knowledge or training could result in increased risk of harm to users patients and bystanders or damage to the device Contact Mortara service for additional training options...

Page 14: ...f external protective earth conductor arrangement is in doubt the device shall be operated from its internal electrical power source 19 Medical devices have been designed to have a higher degree of pr...

Page 15: ...result in previously unidentified risks to patients operators or third parties The manufacturer is not liable for these additional risks as the identification analysis evaluation and control should be...

Page 16: ...to prevent delayed treatment due to an inoperable device 6 The WAM will only work with receiving devices that are equipped with the appropriate option 7 No user serviceable parts are inside the WAM D...

Page 17: ...the FCC rules Operation is subject to the following conditions 1 This device may not cause harmful interference and 2 This device must accept any interference received including interference that may...

Page 18: ...dless of ELI 380 battery AC power state 11 The display of absent waveform while using the WAM wireless acquisition module could be due to the WAM being turned off or having no battery or the WAM being...

Page 19: ...CSA CC22 2 No 601 1 IEC60601 2 25 Wireless Data Transmission 21 ELI 380 electrocardiographs are equipped with a wireless data transmission module WLAN This technology uses radios to transmit data to...

Page 20: ...2 483 13 1 13 Japan 2 401 2 483 13 1 13 802 11a 17 dBm USA Canada 5 15 5 35 13 36 40 44 48 52 56 60 64 149 153 157 50 mW 5 725 5 825 161 165 Europe 5 15 5 35 19 36 40 44 48 52 56 60 64 100 104 108 5...

Page 21: ...nit Network LAN Universal Serial Bus USB Defibrillator proof type CF applied part Patient Cable Input ON OFF Standby power Shift key to enter upper case text on keyboard Do not dispose as unsorted mun...

Page 22: ...RKINGS 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 di...

Page 23: ...ximum 1 10 dilution or a 3 hydrogen peroxide solution 4 For disinfecting the cables and lead wires wipe exterior with a soft lint free cloth using the same solutions as for the device or use highly co...

Page 24: ...GENERAL CARE...

Page 25: ...The device should not be used adjacent to or stacked on top of other equipment If the device must be used adjacent to or stacked on top of other equipment verify that the device operates in an accepta...

Page 26: ...ch an environment Immunity Test Compliance Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD EN 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be w...

Page 27: ...ommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb I...

Page 28: ...wer of Transmitter W Separation Distance According to Frequency of Transmitter m 150 KHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 P d 2 3 P 0 01 0 1 m 0 2 m 0 1 0 4 m 0 7 m 1 1 2 m 2 3 m 10 4 0 m 7 0 m 100...

Page 29: ...itten for clinical professionals with a working knowledge of medical procedures and terminology as required for monitoring cardiac patients Indications For Use Device is indicated for use to acquire a...

Page 30: ...can be printed in standard and Cabrera 1 page 3 1 6 6 3 3 and 12 channel layouts as well as a 2 page 6 channel layout 15 lead ECGs can be printed in standard and Cabrera 1 page 3 1 and 3 3 layouts Rhy...

Page 31: ...INTRODUCTION System Illustration Figure 1 ELI 380 Front Side View Figure 2 ELI 380 Side with Writer Handle Writer Handle 19...

Page 32: ...ELI 380 Rear with Connector Ports 1 2 3 4 5 1 AMxx ECG connector port 2 RJ45 LAN connector port 3 USB connector port 4 USB Device Port 5 100 240V power Base View Figure 4 ELI 380 Base with Battery Com...

Page 33: ...acitive 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 le...

Page 34: ...r or powered off The On Off Standby button is used to power on the device initially enable disable standby mode and shutdown the device During normal operation the ELI 380 will be in standby when the...

Page 35: ...ime Page Up Acquire ECG from Full Disclosure Page Down Settings for the display may be altered by a touchpad click in the real time ECG view A menu allowing for format speed gain filter full disclosur...

Page 36: ...n WAM is in use RF signal strength is displayed with bars WARNING If your device is equipped with a receiver for a Wireless Acquisition Module WAM always make sure that you are receiving data from the...

Page 37: ...ent name date and time Last 10 or Best 10 and the filter setting Settings for display and printout may be altered in this screen by a touchpad tap in the waveform A menu allowing for layout speed gain...

Page 38: ...em 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 bec...

Page 39: ...ture of the best quality 10 second ECG from the last 5 minutes of full disclosure Any 10 second period from up to 20 minutes of accumulated full disclosure is available for viewing printing transmitti...

Page 40: ...ET 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 6...

Page 41: ...DULE WAM W O LEAD WIRES Power Cords Part Number Description 3181 008 POWER CORD US CAN HOSPITAL 5 15P 320 C13 3181 012 01 POWER CORD AUSTRALIA AS3112 IEC320 C13 3181 015 01 POWER CORD UK BS1363 IEC320...

Page 42: ...INTRODUCTION...

Page 43: ...re that the expected WAM module is paired with the cardiograph It is recommended to use visual identifying indicators like color coded or matching labels on the WAM and Cardiograph to avoid mismatch b...

Page 44: ...saved setting either AM12 AM15E or WAM is displayed with FPGA and UTK Firmware versions Select Switch to WAM followed by WAM Pairing Follow the on screen instructions Once the WAM is paired a Successf...

Page 45: ...additional WAM Pairing function becomes available and must be selected Select Done to save changes and exit the menu NOTE The WAM must be paired to ELI 380 before operation Refer to Configuring the WA...

Page 46: ...ark a small black rectangle should be in the lower left corner 4 Manually advance one page of paper beyond the closure point Make sure the paper lies on the black roller evenly within the channel of t...

Page 47: ...powered off after a fifteen minute period of no patient connection With a new fully charged lithium ion battery the ELI 380 is typically capable of acquiring more than 30 resting ECGs with 1 performe...

Page 48: ...battery powered When a patient is connected ECG is displayed and the On Off Standby button is not operational When no patient is connected a quick press of the On Off Standby button as well as closin...

Page 49: ...ith warm soapy water Dry skin vigorously with a pad such as 2 x 2 or 4 x 4 gauze to remove dead skin cells and oil and to increase capillary blood flow NOTE With elderly or frail patients take care to...

Page 50: ...ntifies where the second rib is located and the space just below it is the 2nd intercostal space Palpate and count down the chest until you locate the 4th intercostal space Patient Hookup Summary Tabl...

Page 51: ...d leads or the leads above For right precordial leads use positions symmetrical to left precordial leads V3R symmetrical to V3 position on the right side of the chest V4R on the 5th intercostal space...

Page 52: ...not used All 15 lead wire sets ordered from Mortara include a spacer The spacer prevents insertion of a lead wire plug into a socket Please put the spacer into the E1 socket on the AM15E to prevent i...

Page 53: ...phic field entry Once completed press the tab key or use the touchpad to navigate to the next demographic field Repeat this process until all the demographic fields have been completed NOTE Do not pre...

Page 54: ...ically populating demographic fields via the directory is only possible when the ID formats are the same between records TIP Entry of a lower case letter as the first letter in the last or first name...

Page 55: ...at the right center of the screen to move page by page through the list of patients The current total number of pages is displayed between the double arrows 7 When a patient is selected the available...

Page 56: ...of the following frequency limits by pressing the desired choice on the real time display 40 Hz 150 Hz or 300 Hz for ECG printouts The Filter setting is printed at the bottom right corner of the ECG p...

Page 57: ...d resting ECG interpretation WARNING Always verify the accuracy of Patient demographics prior to printing and or transmitting the ECG Print Transmit and Erase function icons are available for selectio...

Page 58: ...or chest When the condition that triggered the notification message is addressed the VERITAS analysis program collects 10 seconds of new data before analyzing the ECG Message Description Corrective A...

Page 59: ...st Result is enabled the ELI 380 will provide notifications to the user if an acquired ECG meets the CTR criteria Audibly notify user When the CTR dialog box is displayed the unit produces four audibl...

Page 60: ...a 6 lead or 3 lead rhythm print selecting the Leads button in the top right corner of the screen will toggle rhythm printing between limb and chest leads Acquiring a STAT ECG To acquire an emergency S...

Page 61: ...following steps to delete unwanted ECGs that have been saved in the Patient Directory 1 From the real time ECG display select and select the Directory tab 2 In the Directory locate the ECG record s by...

Page 62: ...cted the Best 10 feature automatically becomes available NOTE Best10 function will automatically recognize signal dropout e g with the WAM front end and will not use dropout in creating the Best10 res...

Page 63: ...PC using a direct USB cable The patient records will be transmitted to ELI Link and are then exported and saved in various formats refer to the ELI Link user manual USB Device Connection The ELI 380...

Page 64: ...period of three seconds Transmitting Patient Records to ELI Link Create both an Input folder and Output folder on the PC Configure ELI Link to the individual Input and Output folders Connect the ELI...

Page 65: ...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...

Page 66: ...The Search field can be used to locate patient records by entering free text for name ID DOB or acquisition date The listing will refresh as characters are entered Tap the X at the right of the searc...

Page 67: ...will prompt the message Erase All ECGs for this Patient Select Yes to erase or No to cancel Selection of New ECG will populate the patient information fields Choose Next to move to the real time ECG d...

Page 68: ...ion settings Stored ECGs will remain in the directory until the memory becomes full or the Delete Timeout days setting has been met Only those records that have been marked for deletion will be remove...

Page 69: ...nd synchronize the date and time NOTE ELI 380 supports automatic time synchronization with a remote server Inaccurate time date settings can result in ECGs marked with inaccurate time stamps Confirm t...

Page 70: ...er is selected from the MWL the available patient demographics are automatically filled and the scheduled order information appears in the upper area of the display NOTE If you wish to cancel the orde...

Page 71: ...lect from the real time ECG display and then tap the Patient List tab if necessary 2 The Search field can be used to locate patients by entering free text for name ID Admission ID location room or DOB...

Page 72: ...this is a query the query results will be downloaded If new entries are made to server search results will have to be redownloaded Tap the X at the right of the search field to clear it 3 Sort the re...

Page 73: ...rd Required Date Time Sets the date and time in the appropriate time zone Time zone Daylight savings Sync Date Time No Password Required WAM AM XX Change between the AMxx and the WAM acquisition modul...

Page 74: ...ith Interp Cabrera Plot Format Various rhythm lead selections Rhythm format Rhythm Print Speed Delete Timeout days ADVANCED Password Required Alternate Lead Placement Presents default settings for 3 a...

Page 75: ...CONFIGURATIONSETTINGS UTILITY DESCRIPTION CHOICES ACCESS Service Allows qualified personnel access to Service utilities Refer to the ELI 380 Service Manual ADVANCED Password Required...

Page 76: ...er System The set Custom ID format will not be lost due to power loss or failure or when switching to a different ID format Set the ID format configuration to short long or custom depending on the fac...

Page 77: ...iring ECGs Select Done to save changes and exit this menu or Cancel to exit without saving Configuration Menu WAM AMXX Selecting WAM AMXX allows the clinician to switch between WAM or AMxx patient int...

Page 78: ...format contains the patient s first name patient s last name ID number age height weight gender race medications location room and comment fields 3 A Custom ID format can be downloaded from ELI Link U...

Page 79: ...communication protocol to UNIPRO or DICOM NOTE This setting must be entered under the direction of the IT administrator at the facility where the device is installed ID Edit Disable Yes prevents the u...

Page 80: ...digitized signal acquired for interpretation of the ECG NOTE The Filter setting can also be changed for a single ECG by touching anywhere on the ECG waveform in the real time or acquired view Interp...

Page 81: ...s feature See below Average RR QTcB QTcF Yes for these options will enable the following on the ECG An averaged RR value A Bazett s corrected QT value along with the default linear QTc value A Frideri...

Page 82: ...at plus 10 second rhythm strip of one user selectable lead in a 1 channel format 6 5 seconds of 12 leads in a 6 channel format 3 3 2 5 seconds of 12 leads in a 3 channel format plus 10 second rhythm s...

Page 83: ...V7R Labels will appear on both the display and on printouts Refer to Record An ECG for further detail Select Done to save changes and exit the menu or Cancel to exit without saving Configuration Menu...

Page 84: ...gateway if DHCP is not selected Subnet Mask Allows IT personnel to enter the sub net address if DHCP is not selected Sync IP Allows IT personnel to enter the IP address of the host server The host ser...

Page 85: ...ss 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 If WEP wireless security is enabled on your...

Page 86: ...AN performance may vary due to changes in RF radio frequency properties at your site or to environmental conditions Signal strength can be measured using utilities available in the ELI 380 configurati...

Page 87: ...enter the WEP key number valid range is 1 to 4 o WEP Key ID Allows IT personnel to enter the 128 bit WEP Key ID value 26 digits in 13 sets of two digits 00 to FF WPA PSK or WPA2 PSK WPA Wi Fi Protect...

Page 88: ...nician level password that is required to access the MWL Patient List or Directory tabs Setting Passwords To set or change the Administrator and Technician passwords 1 Select from the real time displa...

Page 89: ...secure Replace faulty electrode patches or lead wires if necessary LEADS OFF OR SEARCHING FOR WAM MESSAGE WAM or AMxx do not acquire ECG Ensure that the correct module is configured in the ELI 380 WA...

Page 90: ...ead If problem persists call Mortara Customer Service to search for possible radio interference sources Transmission Troubleshooting Chart LCD Message Problem Correction TRANSMIT FAILED Unable to tran...

Page 91: ...ICOM order storage failed Directory full mark records for deletion or delete records INCORRECT RESPONSE Connection established then failed Connection started but failed attempt to reconnect NO CUSTOM...

Page 92: ...age 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 conn...

Page 93: ...y service to the device or when non compliant operation is suspected Mortara Instrument Inc recommends the following procedures Confirm proper operation Perform testing to ensure continued electrical...

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