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Mortara ELI 230, User Manual, Page: 1 / 56

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Mortara ELI 230 User Manual Download Page 1

 

 

 

 

 

 

 
 
 
 
 
 
 
 
 
 
 

REF 9515-175-50-ENG Rev G1

 

 
 

ELI 230 

12-LEAD RESTING ELECTROCARDIOGRAPH 

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

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Summary of Contents for ELI 230

Page 1: ...ENG Rev G1 ELI 230 12 LEAD RESTING ELECTROCARDIOGRAPH 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...

Page 2: ...back 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...

Page 3: ...disaster 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 operat...

Page 4: ...S NOTICED 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 LOS...

Page 5: ...tanders or damage to the device Contact Mortara service for additional training options To ensure that electrical safety is maintained during operation from AC power the device must be plugged into a...

Page 6: ...ectrical equipment that has a physical connection to the ELI 230 or the patient or is in the patient environment must comply with applicable safety standards for medical electrical devices All electri...

Page 7: ...d acid type and it is totally maintenance free If the battery appears to become defective refer to Mortara Instrument Service Department Do not pull or stretch patient cables as this could result in m...

Page 8: ...his device must accept any interference including interference that may cause undesired operation of the device WAM IC 3758B WAM2500 UTK IC 3758B UTK2500 The term IC before the certification registrat...

Page 9: ...eing printed the respective lead s will print out as a square wave Overload or saturation of amplifier inputs will also result in lead fault indications As defined by IEC 60601 1 and IEC 60601 2 25 th...

Page 10: ...that the device is charging This light will turn off when the battery is fully charged The power supply cord and appliance inlet serve as the means to disconnect the unit from the mains power supply...

Page 11: ...atient Cable Input Protective earth Defibrillator proof type CF applied part ON OFF power RHY Continuous Rhythm ECG 12 Lead ECG Do not dispose as unsorted municipal waste Per European Union Directive...

Page 12: ...EQUIPMENT SYMBOLS AND MARKINGS xii Package Symbol Delineation This side up Fragile Keep Dry Keep Away from Heat Acceptable Temperature Range Contains Non spillable Battery...

Page 13: ...usehold bleach and water solution minimum 1 500 dilution minimum 100 ppm free chlorine and maximum 1 10 dilution as recommended by the APIC Guidelines for Selection and Use of Disinfectants 4 Use caut...

Page 14: ...GENERAL CARE xiv...

Page 15: ...1 2 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 acc...

Page 16: ...nvironment Emissions Test Compliance Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood c...

Page 17: ...and d is the recommended 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 f...

Page 18: ...ximum Output Power of Transmitter W Separation Distance According to Frequency of Transmitter m 150 KHz to 800 MHz 800 MHz to 2 5 GHz P d 2 1 P d 3 2 0 01 0 1 m 0 2 m 0 1 0 4 m 0 7 m 1 1 2 m 2 3 m 10...

Page 19: ...ecting the Acquisition Module 11 Loading Paper 12 Applying Power 13 Setting Date and Time 14 Using the AM12 Acquisition Module 14 Using the WAM Wireless Acquisition Module 14 Indications for Use WAM 1...

Page 20: ...25 Acquiring an ECG using the WAM 26 Acquiring Rhythm Strips 26 Transfer to a USB Memory Stick 27 Deleting Records 27 SYSTEM SETTINGS SECTION 4 Accessing Configuration Menus 29 Configuration Settings...

Page 21: ...e by a licensed healthcare practitioner in a hospital or clinical setting Personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to card...

Page 22: ...d opinion through diagnostic statements output on the ECG report For additional information on the VERITAS algorithm please refer to the Physician s Guide Adult and Pediatric user manual See Accessori...

Page 23: ...SECTION 1 3 ELI 230 System Illustration Figure 1 1...

Page 24: ...SECTION 1 4 ELI 230 Left Side Figure 1 2 ELI 230 Rear Figure 1 3...

Page 25: ...SECTION 1 5 ELI 230 Base Figure 1 4...

Page 26: ...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...

Page 27: ...ed at the bottom right corner of the ECG printout NOTE ECG paper speed is configured in page one of the Configuration menus Gain Use GAIN to select waveform amplitude for display and printout 5 mm mV...

Page 28: ...y Response 0 05 to 300 Hz Filters High performance baseline filter AC interference filter 50 60 Hz low pass filters 40 Hz 150 Hz or 300 Hz Optional Functions Optional Mortara VERITAS resting ECG inter...

Page 29: ...AY 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 BA...

Page 30: ...ONITORING ELECTRODES CASE 300 9300 033 51 ELECTRODE RESTING TAB BOX 500 9300 033 52 ELECTRODE RESTING TAB CASE 5000 047029 ULTRA II RESTING TAB ELECTRODES 015 0630 00 BLUE MAX RESTING TAB ELECTRODES C...

Page 31: ...tion module for ECG acquisition the connector is not required Refer to Using the WAM Wireless Acquisition Module in this section Figure 2 1 USB port NOTE The ELI 230 must be configured at the factory...

Page 32: ...es to the left 4 Pull paper roll edge up and to the right to allow the paper tray cover to close with paper roll edge extended out of the device Use the release latch to pull the paper tray cover slig...

Page 33: ...time should be approximately 6 hours or less NOTE There are configurable features on the ELI 230 that can be used to help prolong battery life see Section 4 Proper battery care and maintenance will a...

Page 34: ...re operation Indications for Use WAM Indicated for use as a radiofrequency physiological signal transmitter that acquires and delivers RF transmission of electrocardiographic data obtained during rest...

Page 35: ...rint Battery Compartment LED Indicators Using the Buttons The WAM is operated by three buttons located on the front of the device Power On Off Acquiring a 12 lead ECG Acquiring a rhythm strip Approved...

Page 36: ...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 channel transmitted for analysis Resolution 1 875 microvolt LSB...

Page 37: ...raph will not display the ECG Press the power On Off button On initial start up the LEDs will briefly flash yellow and green and the device will beep LED status will indicate the following Solid green...

Page 38: ...tion as well as adequate battery voltage for ECG acquisition LED Indicators LED Audio MODE GREEN off YELLOW off Intermittent beeping Device is on but not paired to an electrocardiograph is out of rang...

Page 39: ...echniques such as forced heat WARNING Prevent liquid from penetrating the device and do not attempt to clean disinfect the device or lead wires by submerging into a liquid autoclaving or steam cleanin...

Page 40: ...SECTION 2 20...

Page 41: ...r Dry skin vigorously with a pad such as a 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 not abrade the s...

Page 42: ...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 Patient Hookup Summary Table AAMI Lead IEC...

Page 43: ...n the header of the ECG printout NOTE If no age was calculated or entered before acquiring an ECG the interpretation will default to a 40 year old male The statement INTERPRETATION BASED ON A DEFAULT...

Page 44: ...k 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 Occur...

Page 45: ...of the last 10 seconds The relationship between the display and the printout is the same what is displayed in the ECG acquisition view is what will be printed In order to change the speed gain filter...

Page 46: ...cover is opened during transmission the WAM will stop transmitting The battery must be reinserted and the cover must be applied to resume operation 8 At the end of the ECG acquisition session the WAM...

Page 47: ...to the USB port on the ELI 230 same port as used for the AM12 acquisition module Once the USB memory stick is connected the device will automatically start transferring all existing records to the USB...

Page 48: ...SECTION 3 28...

Page 49: ...guration screens again To access the configuration menus 1 Select MORE from real time ECG view 2 Select CONFIG 3 Select 1 to print the configuration settings 4 Select 2 to enter the Modify Configurati...

Page 50: ...ilter 40 150 or 300Hz Paper Speed 25 or 50mm sec Rhythm Paper Speed 5 10 25 or 50mm sec Interp Yes or No Reasons Yes or No Append UNCONFIRMED REPORT or Reviewed by Number of copies 0 9 Auto print ECG...

Page 51: ...to conserve the battery life of the device The battery time out will only occur if the keyboard has not been depressed for the time specified The battery time out setting is ignored if an active ECG...

Page 52: ...t This setting allows you to select or suppress the interpretive text on the ECG printout NOTE The ECG interpretation offered by the device are only significant when used in conjunction with a physici...

Page 53: ...ion ECG Data 3 1 2 5 seconds of standard 12 leads in a 3 channel format plus 10 second rhythm strip of one user selectable lead in a 1 channel format 6 5 seconds of standard 12 leads in a 6 channel fo...

Page 54: ...ature 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 Storage Wa...

Page 55: ...eads Correct faulty lead s Lead I Missing Noisy RA LA Check patient prep re prep if necessary with new electrode Lead II Missing Noisy RA LL Check patient prep re prep if necessary with new electrode...

Page 56: ...AC power whenever possible to maximize battery life and for the user to develop a habit of recharging the battery before the unit indicates a low battery condition That is reduced depth of discharge B...

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