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ELI 150 Rx

12-LEAD RESTING ELECTROCARDIOGRAPH

REF 9515-167-51-ENG REV C1

USER MANUAL

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

CAUTION:

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

Summary of Contents for ELI 150 Rx

Page 1: ...D RESTING ELECTROCARDIOGRAPH REF 9515 167 51 ENG REV C1 USER MANUAL Manufactured by Mortara Instrument Inc Milwaukee Wisconsin U S A CAUTION Federal law restricts this device to sale by or on the orde...

Page 2: ...of the receiving organization without the express written consent of Mortara Instrument Inc Mortara is a registered trademark of Mortara Instrument Inc E Scribe ELI and VERITAS are trademarks of Morta...

Page 3: ...Fax 61 2 8814 5399 Headquarters Mortara Instrument Inc 7865 North 86th Street Milwaukee WI 53224 U S A Tel 414 354 1600 Tel 800 231 7437 Fax 414 354 4760 Internet http www mortara com European Union...

Page 4: ...k of the device Care should be taken so that these numbers are not defaced Copyright and Trademark Notices This document contains information that is protected by copyright All rights are reserved No...

Page 5: ...to any Product s returned to Mortara s principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara and ii all risk of loss in tra...

Page 6: ...t be plugged into a hospital grade outlet To maintain designed operator and patient safety peripheral equipment and accessories used that can come in direct patient contact must be in compliance with...

Page 7: ...und potentials that may exist between points of a distributed network system or fault conditions in external network connected equipment network cable shielding where used must be connected to protect...

Page 8: ...European Community Directorate General V in Matters of Radio Frequency Electromagnetic Energy To prevent possible damage to the keyboard do not use sharp or hard objects to depress keys only use fing...

Page 9: ...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 ea...

Page 10: ...led transmission When this occurs patient data will not be erased from the device nor stored in the receiving application ensuring that partial or corrupted data are not made available to the receivin...

Page 11: ...ooms In all the above situations it is recommended to move the device to a proper location and verify with the IT personnel of the facility the areas where the WLAN signals are available User Safety I...

Page 12: ...User Safety Information Continued x...

Page 13: ...xi Symbol Delineation Attention consult accompanying documents Alternating current Protective earth Fuse Telephone line modem Network LAN Defibrillator proof type CF applied part Output Transmit Inpu...

Page 14: ...cept data return Initiate printing of 12 lead ECG Initiate printing of continuous rhythm strip Do not dispose as unsorted municipal waste Per EC Directive 2002 96 requires separate handling for waste...

Page 15: ...lution Wipe and air dry For disinfecting the cables and lead wires wipe exterior with a soft lint free cloth using a solution of Sodium Hypochlorite 10 household bleach and water solution minimum 1 50...

Page 16: ...terilize with ethylene oxide gas EtO at a maximum temperature of 50 C 122 F After EtO sterilization follow the recommendations from the sterilizer manufacturer for required aeration Cautions Improper...

Page 17: ...ble manner in the configuration in which it will be used Fixed portable and mobile radio frequency communications equipment can affect the performance of medical equipment See Table X 4 for recommende...

Page 18: ...4 1 kV for 1 kV for input output lines input output lines Surge 1 kV differential 1 kV differential Mains power quality should be that of a typical IEC 61000 4 5 mode 2 kV mode 2 kV commercial or hosp...

Page 19: ...ng the equipment b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m ELECTROMAGNETIC COMPATIBILITY EMC Continued xvii Emissions Test IEC 60601 Test Level Compliance...

Page 20: ...ut power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power ratin...

Page 21: ...Function Keys 6 ELI 150 Rx Specifications 7 Accessories 8 EQUIPMENT PREPARATION SECTION 2 Section Purpose 9 Connecting the Patient Cable 9 Loading Paper 10 Applying Power 11 Setting Time Date and LCD...

Page 22: ...37 Print Configuration 38 CONNECTIVITY AND ECG TRANSMISSION APPENDIX A Section Purpose 39 ECG Transmission 39 Direct Connection RS 232 40 Modem Transmission 40 Modem Initialization 40 External Modem 4...

Page 23: ...ac patients Indications for Use The ELI 150 Rx is indicated for use in a clinical setting by qualified medical professionals only for recording ECG data of patients The device is indicated for use to...

Page 24: ...hysician with a silent second opinion through diagnostic statements output on the ECG report For additional information on the VERITAS algorithm please refer to the Physician s Guide to ECG Interpreta...

Page 25: ...ELI 150 Rx Left Side Figure 1 2 ELI 150 Rx Rear Figure 1 3 SECTION 1 3...

Page 26: ...SECTION 1 ELI 150 Rx Base Figure 1 4 4 T5A 250V...

Page 27: ...ELI 150 Rx Display and Keyboard Figure 1 5 Automatic Feature Keys Automatic feature keys are used as a one touch operation for ECG Acquisition Rhythm Printing Transmitting Stop SECTION 1 5...

Page 28: ...printout NOTE ECG paper speed is configured in page two of the configuration menus See Section 4 Gain Use F4 Gain to select waveform amplitude for display and printout 5 mm mV 10 mm mV or 20 mm mV Gai...

Page 29: ...rage of ECGs Paper Type Z fold thermal paper 108 mm 4 wide perforated double Z fold 200 double Z fold sheets Thermal Recorder Computer controlled dot array 8 dots mm Thermal Writer Speeds 5 10 25 or 5...

Page 30: ...93 042 51 ELI standard patient cable 12 lead detachable medi clip IEC 9293 043 50 Replacement lead set medi clip AHA 9293 043 51 Replacement lead set medi clip IEC 9325 001 50 Alligator clip adapter 4...

Page 31: ...vide the user with information about Connecting the patient cable Loading paper Applying power Setting time date and LCD contrast Connecting the Patient Cable Figure 2 1 EQUIPMENT PREPARATION SECTION...

Page 32: ...the lower left corner Manually advance one page of paper beyond the closure point of the writer Make sure the paper lays on the black roller evenly within the channel of the paper door If paper is no...

Page 33: ...NOTE Two AC line fuses and one battery fuse are installed on your ELI 150 Rx CAUTION When the battery charge is depleted to its lowest level 10 5V the device will automatically power down To recharge...

Page 34: ...SECTION 2 12...

Page 35: ...nd is comfortable If the table is narrow tuck the patient s hands under his her buttocks to ensure their muscles are relaxed Once all the electrodes are attached ask the patient to lie still and to no...

Page 36: ...Place the electrodes on the inside of each arm between the wrist and elbow Place the electrodes on the inside of each calf between the ankle and knee Place the electrodes at equal distance from the h...

Page 37: ...entifies where the second rib is attached and the space just below it is the 2nd intercostal space Palpate and count down the chest until you locate the 4th intercostal space V1 on the 4th intercostal...

Page 38: ...C2 and V4 C4 Left midclavicular line in the 5th intercostal space Between V4 C4 and V6 C6 5th intercostal space left midaxillary Place the limb electrodes for the arm directly on the left and right m...

Page 39: ...by line down the directory list use Shift F1 to move up Similarly use F2 to page down the directory list use Shift F2 to page up To quickly select a patient name use the keyboard to enter the first f...

Page 40: ...ced with the acquired ECG view To add patient demographics highlight the record from the directory and select F1 ID Examine the display for artifact or baseline drift Re prep and replace electrodes if...

Page 41: ...is displayed in the ECG acquisition view is what will be printed In order to change the speed gain filter or printout format in the acquired ECG view select F5 More To manipulate the print format of...

Page 42: ...hythm printing In addition to manipulating SPEED GAIN and FILTER the user can toggle different lead groups When the default rhythm format is set to either 3 channel or 6 channel the user can change le...

Page 43: ...ture processes In order to map the function and feature keys of the electrocardiograph to a desired bar code font the following values and or symbols must be available NOTE The ELI software will ignor...

Page 44: ...SECTION 3 22...

Page 45: ...us Select F6 More from the real time ECG view Using the keyboard select 3 Set Time Date from the application menu From the Set Time Date screen simultaneously press SHIFT ALT C The first configuration...

Page 46: ...Yes or No AC Filter None 60 Hz 50 Hz Paper Speed 25 mm sec or 50 mm sec Filter Frequency response for printouts 40 Hz 150 Hz or 300 Hz Height Weight Units lb in or kg cm Date Format US mm dd yyyy or E...

Page 47: ...I II III aVR aVL aVF 3 3 Rhythm Lead 3 V1 V6 I II III aVR aVL aVF XMT Media RS 232 modem GSM GPRS LAN WLAN external modem DHCP LAN only Yes or No IP Address XXX XXX XXX XXX Def Gateway XXX XXX XXX XXX...

Page 48: ...unit to default to short ID format for that site number until a new custom ID format see Appendix A is downloaded for the new site number Site Name Second and Third site as well Defines your investiga...

Page 49: ...anguages may require use of special characters in demographic fields This is accomplished by selecting ALT the letter For example is entered by selecting ALT n Hold the ALT key and scroll the letter t...

Page 50: ...e ID screen if records with matching patient ID are found in the ECG directory AC Filter The ELI 150 Rx removes 60 Hz or 50 Hz interference The setting you select depends on the line frequency in your...

Page 51: ...suppress the interpretive text on the ECG report NOTE A qualified physician should review the computer generated ECG interpretation before the treatment of any patient Reasons The reasons statements...

Page 52: ...ked for deletion will be automatically removed or erased based on their acquisition date a first in first out philosophy to make room for the new ECG record ECGs are only erased from the directory whe...

Page 53: ...15200 bps for direct data transmission between the ELI 150 Rx and another Mortara electrocardiograph 38400 bps for a direct connection to an E Scribe Rx system Caps Lock All character entry is transla...

Page 54: ...t s wristband The bar code scanner can also function as a keyboard wedge and input certain function commands such as AUTO RHY XMT and STOP Average RR Enabling this option will display an averaged RR v...

Page 55: ...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...

Page 56: ...s points WPA PSK WPA Wi Fi Protected Access PSK Pre Shared Key security allows for implementation of the personal mode of WPA This mode of encryption employs Temporal Key Integrity Protocol TKIP which...

Page 57: ...CGs or ECG orders needed for particular patients Implementation of an order based workflow can significantly reduce demographic data entry errors at the electrocardiograph Orders are deleted from the...

Page 58: ...SECTION 4 36...

Page 59: ...been transmitted Management of the ECG record is performed within the directory of stored ECGs The desired record must be highlighted in order to view print edit add demographics or to change delete s...

Page 60: ...printout format in the acquired ECG view select F5 More To manipulate the print format of the acquired ECG regardless of the plot format configuration setting select F4 Fmt Select F6 Done to return to...

Page 61: ...er country code This is an internal setting and should not be confused with International calling codes To transmit records select XMT To transmit one ECG select F2 Selec to choose a record from the p...

Page 62: ...From real time ECG view select F6 More to display the application menu From the application menu simultaneously press ALT SHIFT M to access the modem initialization string From the Configure Modem scr...

Page 63: ...public DO B5 Barbados BB B5 East Timor TP B5 Belarus BY B5 Ecuador EC B5 Belgium BE FD Egypt EG B5 Belize BZ B5 El Salvador SV B5 Benin BJ B5 Equatorial Guinea GQ B5 Bermuda BM B5 Eritrea ER B5 Bhutan...

Page 64: ...Netherlands Antilles AN FD Jamaica JM B5 New Caledonia NC B5 Japan JP 00 New Zealand NZ 7E Jordan JO B5 Nicaragua NI B5 Kazakhstan KZ B5 Niger NE B5 Kenya KE B5 Nigeria NG B5 Kiribati KI B5 Niue NU B...

Page 65: ...nited Kingdom UK FD Slovakia SK FD United States US B5 Slovenia SI FD United States Minor Outlying Islands UM B5 Solomon Islands SB B5 Uruguay UY B5 Somalia SO B5 Uzbekistan UZ B5 South Africa ZA 9F V...

Page 66: ...setting the following wireless network parameters must be provided by your IT Manager Host IP Port Number SSID Channel Number NOTE Addresses are always entered as 4 sets of 3 digits therefore an addre...

Page 67: ...nicate to the network It takes approximately 6 seconds from the final button push until you see the link status LEDs illuminate GSM GPRS Mobile Transmission CAUTION GSM GPRS mobile hookup time will va...

Page 68: ...canning networks message will appear on the LCD Once the scanning process is completed the Select Networks screen is available Highlight the desired network and press F3 Selec Receiving ECGs To receiv...

Page 69: ...F2 to scroll through the list use F3 Selec to select the desired order code Confirm or deny your download by selecting F2 or F3 Transmission Status will be displayed for approximately 10 seconds follo...

Page 70: ...ll future ECGs until you select a different ID format in the configuration settings You may alter the ID format configuration to short standard long or custom based on your patient demographic entry n...

Page 71: ...modem and E SCRIBE RX are online Affected Leads Problem Correction LEADS OFF OR ONE OR Lead fail Indication of MORE OF THE FOLLOWING RL RA LA LL V1 V2 V3 V4 V5 V6 RA LA LL Check limb leads V1 V2 V3 V...

Page 72: ...O A link to the access point was Ensure the IP address is correct If problem REMOTE LINK established but the link to the persists contact Mortara Technical Service destination failed UNABLE TO SAVE OR...

Page 73: ...nt dielectric strength mains and patient circuits Battery Maintenance The ELI 150 Rx houses an internal sealed lead acid battery When installed the battery has a shelf life of approximately six months...

Page 74: ...APPENDIX B 52...

Page 75: ...ndardization pulse A base to compare the relationship of QRS complexes to one another Chest leads Precordial leads V1 through V6 AAMI or C1 through C6 IEC GSM Global System for Mobile Communication GP...

Page 76: ...hmia that has its origin in the atrium Premature Ventricular Complex PVC An arrhythmia that has its origin in the ventricle Preview function Preview screen shows the ECG traces as they will appear on...

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