ELI 230
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1. J Mortara www mortara com REF 9515 175 50 ENG Rev D1 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 Mortara Copyright 201 1 by Mortara Instrument Inc 7865 N 86th Street Milwaukee Wisconsin 53224 This document contains confidential information that belongs to Mortara Instrument Inc No part of this document may be transmitted 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 AMI2 ELI VERITAS and WAM are trademarks of Mortara Instrument Inc V1 10 TECHNICAL SUPPORT AND SERVICE 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 Representative Mortara Rangoni Europe Srl European Headquarters Via Cimarosa 103 105 40033 Casalecchio di Reno BO Italy Tel 39 051 298 7811 Fax 39 051 613 3582 Service Technical Support Group Mortara Instrument Inc 7865 North 86th Street Milwaukee WI 53224 U S A Tel 414 354 1600 Service 888 MORTARA 888 667 8272 Fax 414 354 4760 E mail techsupport mortara com 242. 1 or 1 to advance year month day hour or minute Select DONE to save changes Select DONE to return to the Configuration menu and DONE again to return to real time ECG view Using the WAM or AM12 Acquisition Modules ECG acquisition and rhythm strip printing can also be performed at the WAM or the AMI2 acquisition module To use the WAM refer to the WAM user manual To use the AM12 refer to the AMI2 short form instruction card 14 NOTE The ELI 230 must be configured at the factory for use with the WAM Select MORE followed by CONFIG o determine the device s setting Wireless Option Available will display if the ELI 230 is configured to work with the WAM NOTE WAM must be paired to electrocardiograph before operation RECORD ECG SECTION 3 Patient Preparation Before attaching the electrodes assure the patient fully understands the procedure and what to expect e Privacy is very important in assuring the patient is relaxed e Reassure the patient that the procedure is painless and that the electrodes on their skin are all that they will feel e 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 e Once all the electrodes are attached ask the patient to lie still and to not talk Explain this will assist you in acquiring a good ECG Preparing Patient Skin Thorough skin preparation is very important
3. Reasons The reasons statements indicate why a particular interpretive statement was printed Reasons statements print enclosed in square brackets within the interpretive text if the interpretation option is turned on Turning the reasons statement function on or off does not affect the measurements performed or the interpretive statements selected by the analysis program For Example Anteroseptal Infarct 40 ms Q WAVE IN V1 V4 Where Anteroseptal Infarct 15 the interpretive statement and 40 ms Q WAVE IN V1 V4 is the reason statement or explanation as to why the interpretive statement was printed Append A status or statement phrase can be appended to the ECG and printed under the interpretive text printout Either unconfirmed report or reviewed by can be selected Number of Copies Defines the number of printed copies when an ECG 15 taken A zero 0 setting prints the original only one 1 prints the original plus 1 copy two 2 prints the original plus 2 copies and so on Up to 9 copies may be selected 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 1s 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 NOTE The ELI 230 cannot acquire more than the current E
4. See Accessories Supported print formats include standard 3 1 6 or 12 channel or Cabrera 3 1 6 or 12 channel in automatic mode and 3 6 or 12 channel rhythm strip printing During rhythm strip printing user can toggle between the various 3 or 6 channels to print The device can operate on battery or line power The ELI 230 includes e Acquisition module Hospital grade power cord l pack paper 210mm roll paper User manual CD Accessory starter kit SECTION 1 ELI 230 System Illustration Figure 1 1 n oo MMortara ___Ready to print _ PRINT I T HORE ELI 230 SECTION 1 ELI 230 Left Side Figure 1 2 ELI 230 Rear Figure 1 3 100 240V 50 60Hz 110VA SECTION 1 ELI 230 Base Figure 1 4 JMortara INSTRUMENT MILWAUKEE WI USA ELI 230 ELECTROCARDIOGRAPH MEDICAL EQUIPMENT oM A EAN moms 0450 5P35 IEC0601 2 25 OPTIONAL INTERNAL RADIO MODEL UTK 2 this device must accept any interference received including interference that may cause undesired operation FCC ID HJR UTK2500 1C 3758B UTK2500 ELI 230 Display Overview Figure 1 5 Q 1Mortara HR 150Hz 13 29 PRINT BEST10 MORE DONE ELI 280 Function Keys Function Keys SECTION 1 Heart Rate Speed Best 10 Gain Filter Clock Function Key Labels Function keys activate the liquid crystal display LCD label above each function key LC
5. There is natural resistance on the skin surface from various sources such as hair oil and dry dead skin Skin preparation 15 intended to minimize these effects and maximize the quality of the ECG signal To prepare the skin e Shave hair from electrode sites if necessary e Wash area with warm soapy water e 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 skin causing discomfort or bruising Clinical discretion should always be used in patient preparation Patient Hookup Correct electrode placement is important for acquiring a successful ECG A good minimum impedance pathway will provide superior noise free waveforms Good quality silver silver chloride Ag AgCl electrodes should be used TIP Electrodes should be stored in an air tight container Electrodes will dry out if not stored properly which will cause loss of adhesion and conductivity To Attach the Electrodes Expose the arms and legs of the patient to attach the limb leads Place the electrodes on flat fleshy parts of the arms and legs If a limb site 15 not available place the electrodes on a perfused area of the stump Attach the electrodes to the skin A good test for firm electrode contact 15 to slightly tug on the electrode to check adhesion If the electrode moves freely it needs to be changed If the electrode doe
6. buffer Users can switch between BEST 10 or LAST 10 by selecting BEST10 or LAST10 from acquired ECG view Storage Warning Determines whether a storage warning will display when the electrocardiograph is near the maximum storage level 27 25 SECTION 4 MAINTENANCE AND TROUBLESHOOTING APPENDIX A 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 USB MEMORY USB memory stick not Ensure the USB memory stick contains recognized or working a Records directory Verify device displays real time ECG view USB memory stick must be formatted to FAT 32 ECG Troubleshooting Chart Affected Leads Problem Correction LEADS OFF OR ONE OR MORE OF Lead fail Indication of THE FOLLOWING RA LA LL V1 RL RA LA LL V1 V2 V3 V4 V5 V6 V2 V3 V4 V5 V6 Check limb leads Correct faulty lead s Lead Missing Noisy RA LA Check patient prep re prep if necessary with new electrode Lead Il Missing Noisy RA LL Check patient prep re prep if necessary with new electrode Lead Ill Missing Noisy LA LL Check patient prep re prep if necessary with new electrode All High Freq Noise Notch down filter from 300 Hz to 150 Hz check proximity to power cables Test Operation After cleaning and inspecting the ELI 230 prop
7. 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 MORE from real time ECG view followed by ID The patient demographic labels available are determined by the ID format selected in the configuration settings In addition to short you may select None Sex Age or Sex DOB ID formats Use the arrow function keys to move through the available demographic fields At the desired field select Edit When entering last name first name or ID use the arrow function keys gt A V to move the cursor to the right or left or up and down through the alphanumeric character menu Select the desired character and press Enter Once all the characters have been selected move the cursor to DONE and press Enter to return to the patient demographic data entry menu When entering date of birth the A and V function keys are used to increase or decrease selections for day month and year Select DONE to return to the patient demographic data entry menu age 15 automatically calculated When selecting gender use the MALE or FEMALE function key and select DONE When finished with the data entry fields select DONE to return to real time ECG view Skipped fields will appear as a blank field on the h
8. CG Once DONE is selected the ELI 230 starts monitoring or acquiring new ECG data 26 SECTION 4 Plot Format Defines the default for one of the available plot formats in either standard or Cabrera presentation Regardless of the plot format selected 10 seconds of 12 leads are always stored ECG plot options are Format Option ECG Data 2 5 seconds of standard 12 leads in a 3 channel format plus 3 1 10 second rhythm strip of one user selectable lead in a 1 channel format 5 seconds of standard 12 leads in a 6 channel format 10 seconds of standard 12 leads in a 12 channel format Rhythm Leads Identifies the 3 or 6 user selectable 10 second rhythm leads for the 3 and 6 channel ECG printout NOTE Rhythm acquisition is not stored in memory only printed NOTE See Section 3 to acquire a rhythm printout Average RR Enabling this option will display an averaged RR value to appear on the report QTcB Enabling this option will display a Bazett s corrected QT value on the report along with the default linear QTc value QTcF Enabling this option will display a Fridericia corrected QT value on the report along with the default linear QTc value Pace Spike Channel Determines whether a pacemaker spike notification marker will display 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
9. D labels functions change depending upon the screen displayed If the label 15 blank the function key is not active SECTION 1 The ELI 230 features a V4 VGA 320 x 240 pixel LCD color display for valuable preview of ECG waveform function key labels and other parameters as explained below Heart Rate HR When a patient is connected to the electrocardiograph his her HR 15 displayed in real time The HR is the average ventricular rate measured over an average of the patient s last five beats NOTE Ifa lead fail occurs a yellow indicator flashes in the middle of the display signifying which lead has the problem ECG Use ECG to acquire an ECG 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 Gain Use GAIN to select waveform amplitude for display and printout 5 mm mV 10 mm mV or 20 mm mV Gain is printed at the bottom right corner of the ECG printout Filter Use FILT to select the low pass filter options 40 Hz 150 Hz or 300 Hz for ECG printouts Filter is printed at the bottom right corner of the ECG printout Clock Time display with hour minutes and seconds resolution See Section 2 for setting a new time and
10. E Rhythm printouts are only possible from the real time ECG view NOTE Rhythm acquisitions are only printed and not stored in the ELI 230 The rhythm activity screen appears as soon as the writer begins printing the rhythm strip The waveform display format is similar to the real time ECG view however new functions keys are available during rhythm printing In addition to manipulating SPEED GAIN and FILTER the user can toggle different lead groups during printing by selecting LEADS The change in lead groups is apparent on the printout whereas the waveform display will remain in the default display of 2 5 seconds of Leads I II and V1 V6 During 3 channel rhythm printing the available lead groups are l Default user selected in configuration 2 II I 3 aVR aVL aVF 4 VI V2 V3 5 V4 V5 V6 During 6 channel rhythm printing the available lead groups are l Default user selected in configuration 2 LILIII aVR aVL aVF 3 VI 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 20 SECTION 3 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 Using a PC create a directory on the USB memory stick called Records When done plug the USB memory stick into the USB port on the ELI 230 same port as
11. If workflow permits patient demographic entry prior to acquisition enter the patient identification information as explained in Patient Demographics After you complete the last data entry field select DONE to return to the real time ECG view NOTE A STAT ECG can be acquired using either the WAM or AMI2 acquisition module as well as the electrocardiograph 17 SECTION 3 Examine the display for any of the following notification messages e Leads Off displays when patient is not connected e Lead Fault displays faulty lead s Re prep and replace electrode s if necessary to obtain satisfactory waveform s See Patient Preparation e Electrode Wrong Position displays one of the following when a lead is connected incorrectly or is in the wrong location See Patient Preparation o Limb leads misplaced o LA or LL misplaced o RA or RL misplaced o RAorLL misplaced RA or LA misplaced o V or V2 misplaced o V2or V3 misplaced V3or V4 misplaced o V4 or V5 misplaced VS or V6 misplaced 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 e Searching for WAM displays when the WAM is not det
12. 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 A Caution s To prevent possible damage to the keyboard do not use sharp or hard objects to depress keys only use fingertips Do not attempt to clean the device or patient cables by submersing into a liquid autoclaving or steam cleaning as this may damage equipment or reduce its usable life Wipe the exterior surfaces with a warm water and mild detergent solution and then dry with a clean cloth Use of unspecified cleaning disinfecting agents failure to follow recommended procedures or contact with unspecified materials could result in increased risk of harm to users patients and bystanders or damage to the device No user serviceable parts inside Screw removal by qualified service personnel only Damaged or suspected inoperative equipment must be immediately removed from use and must be checked repaired by qualified service personnel prior to continued use The rechargeable internal battery is a sealed lead 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 mec
13. Y OF MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE 111 1V WARRANTY INFORMATION USER SAFETY INFORMATION AN Warning Means there is the possibility of personal injury to you or others Caution Means there 15 the possibility of damage to the device Note Provides information to further assist in the use of the device Warning s e This manual gives important information about the use and safety of this device Deviating from operating procedures misuse or misapplication of the device or ignoring specifications and recommendations could result in increased risk of harm to users patients and bystanders or damage to the device e Device captures and presents data reflecting a patient s physiological condition that when reviewed by a trained physician or clinician can be useful in determining a diagnosis however the data should not be used as a sole means for determining a patient s diagnosis e Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient care and adequately trained in the use of this device Before attempting to use this device for clinical applications the operator must read and understand the contents of the user manual and other accompanying 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 opti
14. a a i 20 Transferring toa USB Memory SUCR cesser uuu 21 DEI EE EIU 2 SYSTEM SETTINGS SECTION 4 Accessing Configuration Menus 22 a a en ne 25 MAINTENANCE AND TROUBLESHOOTING APPENDIX A OURS DOES a dimidium E BM 29 d OS e 6 1 29 Recommendations to Biomedical Staff une ee er rear 30 BALE N S a TR m 30 do M aiuta Pink D suse 30 XV TABLE OF CONTENTS XVI INTRODUCTION SECTION 1 Manual Purpose This manual is intended to provide the user with information about Using and understanding the ELITM 230 electrocardiograph the function keys and the display screen e Preparing the ELI 230 for use Section 2 e Acquiring printing and storing an ECG Section 3 e System settings Section 4 e Maintenance and troubleshooting Appendix A Audience This manual is written for clinical professionals They are expected to have working knowledge of medical procedures and terminology as required for monitoring cardiac patients Indications for Use Device 15 indicated for use by a licensed healthcare practitioner in a hospital or clinical setting Personnel must be experienced in cardiovascular problematic situations and emergency procedures or patholog
15. aVR aVL aVF V1 V2 V3 V4 V5 V6 in any combination Avg RR Yes or No QTcB Yes or No 24 SECTION 4 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 Select CONFIG Select 2 Modify Configuration Use A or V to select Language Press until the desired language appears Press DONE to return to the Configuration menu Press DONE to return to real time ECG view ue ien Battery Time Out Determines when the electrocardiograph will switch off in order 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 15 1gnored if an active ECG signal 15 detected during transmission or while rhythm printing Time Mode Determines if time displays in a standard 12 hour or 24 hour clock setting ID Format Defines the format for the patient data prompts There are four standard formats None Short Sex Age and Sex DOB NOTE When ID format is set to None no age DOB and gender interpretation setting is automa
16. al performance is observed additional measures may be necessary such as reorienting or relocating the equipment b Over the frequency range 150 kHz to 80 MEZ field strengths should be less than 3 V m xili ELECTROMAGNETIC COMPATIBILITY EMC Table X 4 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 Rated Maximum Output Power Separation Distance According to Frequency of Transmitter m of Transmitter W 150 KHz to 800 MHz 800 MHz to 2 5 GHz For transmitters rated at a maximum output 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 rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affec
17. date When the ECG is acquired the time displayed is the printed ECG acquisition time SECTION 1 Specifications Feature Specification Instrument Type 12 lead electrocardiograph Input Channels Simultaneous acquisition of all 12 leads Standard Leads Acquired l II Hl aVR aVL aVF V1 V2 V3 V4 V5 V6 Waveform Display Backlit 4 VGA 320 x 240 LCD color display 4 4 or 6 6 lead presentation Input Impedance Meets or exceeds the requirements of ANSI AAMI EC1 1 Input Dynamic Range Electrode Offset Tolerance Common Mode Rejection Patient Leakage Current Meets or exceeds requirements of ANSI AAMI ES1 Chassis Leakage Current Digital Sampling Rate 40 000 s sec channel used for pacemaker spike detection 1000 s sec channel used for recording and analysis Frequency 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 interpretation with age and gender specific algorithm Paper Thermal roll paper 210 mm 8 25 wide Thermal Printer Computer controlled dot array 8 dots mm ECG Storage Internal storage up to 20 ECG records external storage to USB memory Stick Weight 5 8 Ibs 2 63 kg including battery without paper Power Requirements Universal AC power supply 100 240 VAC at 50 60 Hz 110 VA internally rechargeable battery SECTION 1 Accessories Part Numbers Desc
18. e Cleaning Exterior Surfaces and Patient Cable l Remove cables and lead wires from device before cleaning For general cleaning of cables and lead wires use a soft lint free cloth lightly moistened with a mild soap and water solution Wipe and air dry 3 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 1 500 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 caution with excess liquid as contact with metal parts may cause corrosion Do not immerse cable ends or lead wires immersion can cause metal corrosion 6 Do not use excessive drying techniques such as forced heat Un 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 cleaning Never expose lead wires to strong ultra violet radiation Do not sterilize the device or ECG lead wires with Ethylene Oxide EtO gas Cleaning the Device Disconnect the power source Clean the exterior surface of the device with a damp soft lint free cloth using a solution of mild detergent diluted in water After washing thoroughly dry off the device with a clean soft cloth or paper towel Cautions Improper cleaning products and processes can damage the de
19. e patient for excessive skin irritation inflammation or other adverse reactions Electrodes are intended for short term use and should be removed from the patient promptly following testing vi USER SAFETY INFORMATION To avoid potential for spread of disease or infection single use disposable components e g electrodes must not be reused To maintain safety and effectiveness electrodes must not be used beyond their expiration date To ensure the safety of both the patient and the device 1 5 meters 5 of open area should surround the patient 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 All signal input and output I O connectors are intended for connection of only those devices complying with IEC 60601 1 or other IEC standards e g IEC 60950 as appropriate to the device Connecting additional devices to the device may increase chassis and or patient leakage currents To maintain operator and patient safety consideration should be given to the requirements of IEC 60601 1 1 and leakage currents should be measured to confirm no electric shock hazard exists The device has not been designed for use with high frequency HF surgical equipment and does not provide a protective means against hazards to the patient
20. eader 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 AGE OF 40 YEARS will be added to the interpretation text NOTE lf an age of zero 0 is used the interpretation will default to a 6 month old infant The statement INTERPRETATION BASED ON A DEFAULT AGE OF 6 MONTHS will be added to the interpretation text NOTE Where global measurement values are not available i e rate interval axis text such as or or similar will display print for the unavailable value NOTE If ID Format is set for None in the configuration settings the interpretation function will be turned off regardless of its setting In order to maintain interpretive statements the ID Format must be set to Short Sex Age or Sex DOB date of birth ECG Acquisition Printing Storage ECG acquisition and rhythm strip printing can also be performed at the WAM wireless acquisition module or the AMI2 acquisition module To use either acquisition module with the ELI 230 refer to the WAM user manual or the AMI2 short form instruction card Acquisition Once the patient 1s connected the device continuously collects and displays ECG data therefore before you press ECG or RHY you should instruct the patient to relax in a supine position to ensure that the ECG is free from artifact noise due to patient activity
21. ected Occurs usually when the WAM is out of range or not powered on When the problem is corrected the device waits for 10 seconds of good data before analyzing the ECG Please refer to the following troubleshooting guide based on Einthoven s Triangle Artifact Check Electrode Lead II and III artifact Poor LL electrode or left leg tremor Lead and II artifact Poor RA electrode or right arm tremor Lead and III artifact Poor LA electrode or left arm tremor V Leads Re prep site amp replace electrode LL Press ECG The real time ECG view is then replaced with the acquired ECG view The default real time ECG view 15 not available in the acquired ECG view for navigation purposes NOTE New LCD label functions are available in the acquired ECG view NOTE Functions are not available during acquisition 18 SECTION 3 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 The best 10 seconds is determined based upon measures of high and low frequency noise found in the 10 second ECG segments Should a single limb lead or two precordial lead fail conditions occur the Best 10 feature 15 disabled until the limb lead fail or precordial lead fail condition 15 resolved At resolution the Best 10 feature becomes available and the selection buffer cont
22. er 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 There should be no evidence of print head dot failure e g breaks in printing forming horizontal streaks Paper motion should be smooth and consistent during printing Waveforms should appear normal with proper amplitude and without distortion or excessive noise 29 Recommendations to Biomedical Staff Following any service to the ELI 230 or when non compliant operation is suspected Mortara Instrument Inc recommends the following procedures e Confirm proper operation Perform testing to ensure continued electrical safety of the device use IEC 60601 1 or ANSI AAMI ESI methods and limits e patient leakage current e chassis leakage current e earth leakage current e dielectric strength mains and patient circuits Battery Maintenance The ELI 230 houses an internal sealed lead acid battery When installed the battery has a shelf life of approximately six months without recharging If the battery has been stored for a long period in a discharged state it may not be able to regain its capacity even if it 15 recharged For information about replacing the battery please refer to the ELI 230 service manual Mortara Instrument Inc recommends that the ELI 230 be plugged into AC power whenever possible to maximize battery life and for
23. fied 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 2 The equipment must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected Class A The equipment is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for RF Emissions CISPR 11 Harmonic Emissions IEC 61000 3 2 domestic purposes Table X 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity Voltage Fluctuations Flicker Emissions IEC 61000 3 3 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 Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field Compliance 6 KV contact 8 kV air 2 KV for power supply lines 1 KV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT fo
24. hanical and or electrical failures Patient cables should be stored after forming them into a loose loop No calibration or special equipments are needed for the proper operation or maintenance of the device When necessary dispose of the device its components and accessories e g batteries cables electrodes and or packing materials in accordance with local regulations USER SAFETY INFORMATION Note s Patient movements may generate excessive noise that may affect the quality of the ECG traces and the proper analysis performed by the device Proper patient preparation 15 important to proper application of ECG electrodes and operation of the device There is no known safety hazard if other equipment such as pacemakers or other stimulators is used simultaneously with the device however disturbance to the signal may occur If an electrode is not connected properly to the patient or one or more of the patient cable lead wires are damaged the display will indicate a lead fault for the lead s where the condition 15 present and if the signal 15 being printed the respective lead s will print out as a square wave As defined by IEC 60601 1 and IEC 60601 2 25 the device is classified as follows e Class I equipment or internally powered e Type CF defibrillation proof applied parts e Ordinary equipment e Equipment not suitable for use in the presence of a flammable anesthetic mixture e Continuous operation NOTE From a safet
25. hour Technical Support Same day Shipment of Replacement Parts Biomedical Training Classes Extended Warranties Service Contracts Sales Support Supplies amp Accessories Mortara Instrument Inc 7865 North 86th Street Milwaukee WI 53224 U S A Tel 414 354 1600 Fax 414 354 4760 E mail sales g mortara com Mortara Instrument Germany Kaninenbergh he 50 45136 Essen Germany Tel 49 201 18 55 69 70 Fax 49 201 18 55 69 77 Mortara Instrument Netherlands Postbus 324 5680 AH Best Industrieweg 160b 5683 CG Best Netherlands Tel 31 499 377310 Fax 31 499 377908 Mortara Instrument Australia PO Box 7568 Baulkham Hills NSW 2153 Unit 28 9 Hoyle Avenue Castle Hill NSW 2154 Australia Tel 61 2 8070 9303 Fax 61 2 9899 9478 NOTICES Manufacturer s Responsibility Mortara Instrument Inc is responsible for the effects on safety and performance only if e Assembly operations extensions readjustments modifications or repairs are carried out only by persons authorized by Mortara Instrument Inc e The device is used in accordance with the instructions for use Responsibility of the Customer The user of this device 15 responsible for ensuring the implementation of a satisfactory maintenance schedule Failure to do so may cause undue failure and possible health hazards Equipment Identification Mortara Instrument Inc equipment is identified by a serial and reference number on the back of the dev
26. ice 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 part of this document may be photocopied reproduced or translated to another language without prior written consent of Mortara Instrument Inc Other Important Information The information in this document is subject to change without notice Mortara Instrument 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 Mortara Instrument Inc assumes no responsibility for any errors or omissions that may appear in this document Mortara Instrument Inc makes no commitment to update or to keep current the information contained in this document ii WARRANTY INFORMATION Your Mortara Warranty MORTARA INSTRUMENT INC hereinafter referred to as Mortara hereby warrants that Mortara 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 Mortara or an authorized distributor or representative of Mortara The warranty period is defined as twenty four 24 months following the date of shipment from Mortara Normal use service and maintenance means operation and maintenance in accordance with approp
27. ies related to cardiac involvements Device 15 indicated for use to acquire analyze display and print electrocardiograms Device 15 indicated for use for patients of any age Device 15 indicated for use to provide interpretation of the data for consideration by a physician It is not intended as a sole means of diagnosis The interpretations of ECG offered by the device are only significant when used in conjunction with physician over read as well as consideration of all other relevant patient data The device 15 not intended to be used as a vital signs physiological monitor The cardiac data and analysis provided 15 reviewed confirmed and used by trained medical personnel in the diagnosis of patients with various rhythm patterns The device 15 not designed for use in highly invasive environments such as an operating theatre SECTION 1 System Description The ELI 230 is a 12 lead diagnostic electrocardiograph used for acquiring viewing and printing of adult and pediatric 12 lead ECG data The device is optionally equipped with Mortara Instrument s VERITASTM resting ECG interpretation algorithm with age and gender specific criteria If this option 15 enabled see Section 4 the VERITAS algorithm can provide an over reading physician with a silent second opinion through diagnostic statements output on the ECG report For additional information on the VERITAS algorithm please refer to the PAysician s Guide Adult and Pediatric user manual
28. inues Users can switch between BEST 10 or LAST 10 by selecting BEST10 or LAST10 Switching the view will automatically generate a second printout if auto print is selected Otherwise the clinician will be required to select PRINT Pacemaker Spike Notification Turn the pacemaker spike notification marker on or off by selecting Yes or No in the configuration menu Selecting Yes will cause a spike location marker to display at the bottom of the printout Printing If Auto Print is enabled in the configuration an ECG is printed following acquisition To print a manual printout select PRINT If the auto print configuration is disabled a 10 second preview will assist in ensuring a quality ECG acquisition prior to printing When you acquire an ECG the electrocardiograph captures a minimum of the last 10 seconds The relationship between the display and the printout 15 the same what 15 displayed in the ECG acquisition view 15 what will be printed In order to change the speed gain filter or print format in the acquired ECG view select MORE To manipulate the print format of the acquired ECG regardless of the plot format configuration setting select FMT Continue to press FMT until the desired print format 1s displayed then select BACK The display will return to acquired ECG view Select PRINT to make an ECG printout copy in the new plot format select DONE to return to the real time ECG view Storage The ELI 230 will automaticall
29. ll 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 slightly to the right and down until the cover latches in a locked position You will hear a sharp click when the cover is latched properly this may require pressing down firmly on the top and bottom tabs of the paper tray cover with your thumbs WARNING Risk of injury to fingers in paper tray door or platen drive mechanisms NOTE For proper performance of thermal writer be certain to use Mortara recommended thermal paper 12 SECTION 2 Applying Power l 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 15 connected device can be put into standby mode 2 Ifusing battery power press the power ON OFF button located on the face panel of the device Reference Figure 1 5 Indicators on the keyboard will illuminate as follows AC Power Battery e The AC power LED indicator illuminates when device is connected to mains AC power e The battery LED indicator illuminates when charging and flashes when battery 15 low it will turn off when the battery is fully charged The ELI 230 should be connected to AC power for recharging when not in use TIP Check battery voltage by selecting MORE followed by CONFIG NOTE For typical usage ba
30. of a Product s by its acceptance and purchase thereof acknowledges and agrees that Mortara 15 not liable for loss harm or damage due directly or indirectly to an occurrence or consequence therefrom relating to the Product s If Mortara should be found liable to anyone under any theory except the expressed warranty set forth herein for loss harm or damage the liability of Mortara shall be limited to the lesser of the actual loss harm or damage or the original purchase price of the Product s when sold EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH AS PAPER BATTERIES ELECTRODES PATIENT CABLES LEAD WIRES AND MAGNETIC STORAGE MEDIUMS EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES A PURCHASER S SOLE EXCLUSIVE REMEDY AGAINST MORTARA 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 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 DAMAGE OR EXPENSE OF ANY KIND INCLUDING LOSS OF PROFITS WHETHER UNDER TORT NEGLIGENCE OR STRICT LIABILITY THEORIES OF LAW OR OTHERWISE THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANT
31. ons e To ensure that electrical safety is maintained during operation from AC power the device must be plugged into a hospital grade outlet e To maintain designed operator and patient safety peripheral equipment and accessories used that can come in direct patient contact must be in compliance with UL 60601 1 IEC 60601 1 and IEC 60601 2 25 Only use parts and accessories supplied with the device and available through Mortara Instrument Inc e Patient cables intended for use with the device include series resistance 9 Kohm minimum in each lead for defibrillation protection Patient cables should be checked for cracks or breakage prior to use e Conductive parts of the patient cable electrodes and associated connections of type CF applied parts including the neutral conductor of the patient cable and electrode should not come into contact with other conductive parts including earth ground e ECG electrodes could cause skin irritation patients should be examined for signs of irritation or inflammation e avoid the possibility of serious injury or death during patient defibrillation do not come into contact with device or patient cables Additionally proper placement of defibrillator paddles in relation to the electrodes 15 required to minimize harm to the patient e This device was designed to use the electrodes specified in this manual Proper clinical procedure must be employed to prep the electrode sites and to monitor th
32. r 0 5 cycle 40 UT 60 dip in UT for 5 cycles Compliance Level 6 KV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT 29556 dip in UT for 0 5 cycle 40 UT 6096 dip in UT for 5 cycles Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the AC Mains voltage prior to application of the test level xli ELECTROMAGNETIC COMPATIBILITY EMC Table X 3 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 IEC 60601 Test Emissions Test Level Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz Radiated RF 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz Compliance Le
33. riate instructions and or information guides This warranty does not apply to damage to the Product s caused by any or all of the following circumstances or conditions a Freight damage b Parts and or accessories of the Product s not obtained from or approved by Mortara c Misapplication misuse abuse and or failure to follow the Product s instruction sheets and or information guides d Accident a 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 operating conditions THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS OR ANY PRODUCT S FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN DEFECTIVE This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period Mortara s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Product s 1 of all carrier charges with respect 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 11 all risk of loss in transit It is expressly agreed that the liability of Mortara 1s limited and that Mortara does not function as an insurer A purchaser
34. ription 9100 029 50 PAPER CASE ELI 230 ROLL W HEADER 210mm 9293 048 50 AM12 PATIENT CABLE ASSEMBLY 30012 019 50 WIRELESS ACQUISITION MODULE WAM 9300 036 ELECTRODES RESTING 24mm SUCTION PK 6 Contact your dealer or go to www mortara com for more information 10 SECTION 1 EQUIPMENT PREPARATION SECTION 2 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 AMI2 acquisition module When using the WAMTM wireless acquisition module for ECG acquisition the connector is not required Refer to the WAM user manual for pairing instructions to the ELI 230 Figure 2 1 USB port NOTE The ELI 230 must be configured at the factory for use with the WAM Select MORE followed by CONFIG o determine the device s setting Wireless Option Available will display if the ELI 230 is configured to work with the WAM NOTE WAM must be paired to electrocardiograph before operation 1 SECTION 2 Loading Paper Figure 2 2 1 Remove the outer packaging from the paper roll 2 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 Remove any empty paper rolls 3 Place the roll of thermal paper into the paper tray such that the grid side of the paper 1s up and paper roll edge faces to the left 4 Pu
35. s not move easily a good connection has been obtained pud 15 SECTION 3 For accurate V lead placement and monitoring it is important to locate the 4 intercostal space The 4 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 Thus locate the 2 intercostal space by first palpating the little bony prominence called the Angle of Lewis where the body of the sternum joins the manubrium This rise in the sternum identifies where the second rib is attached and the space just below it is the 2 intercostal space Palpate and count down the chest until you locate the 4 intercostal space Patient Hookup Summary Table Electrode Position On the 4 intercostal space at the right Angle of Lewis sternal border va On the 4 intercostal 7 V5 space at the left sternal v2 V6 NA e INS v3 NAS Midway between a e SO V2 C2 and V4 C4 gt a REED a electrodes On the 5 intercostal space at the left RA LA midclavicular line RL LL Midway between V4 and V6 electrodes On the left midaxillary line horizontal with V4 electrode On the deltoid forearm or wrist On the thigh or ankle 16 SECTION 3 Patient Demographic Entry Patient demographic information can be entered before acquisition only if the patient is connected to the ELI 230 The entered
36. ted by the absorption and reflection from structures objects and people XIV TABLE OF CONTENTS INTRODUCTION SECTION 1 DEU AL rq o oT T l E TTE I Tot ee ed ren I DISC ION ee ee ee 2 Figure 1 1 ELI 230 System Illustration 3 guru LAO IUS URP ui ERR 4 e E A E E A O A E E E A N E A E AT 4 rus ATE OTD RT m uu ums 5 Figure 1 5 ELI 230 Display Overview 6 PR D E _ 6 D D C NN 077 OS NERONI IRI T 8 ACC SOT CS 9 EQUIPMENT PREPARATION SECTION 2 Connecting the Acguisition Mod le er 11 Eoin P Rm mc 12 ADD E EE 13 Setting Date and Time CRRRRRRRRRRRRRMMMMMMMMMMMMMMMMEEEEEEEEEEEEEEEEEEEEEEEEEEEEMMMM 14 Using the WAM or AMI2 Acquisition Modules 14 RECORD ECG SECTION 3 E U MN EUNTEM EM ENNIUS REED M EE 15 Pati HE OORO a ee dup MR ee 15 Patient Demographic Entry ii hh huh ahhh a ahhhssasassssssssssssssssss s sas g asas a ssa ss asa anna 17 BCG Acquisition Prinlin9 Storage eine EEEE EA E i SA IJ ZUCQUISTELORI E 17 urbi et ee ee ee 19 a e E e E E O i 19 ACQUIS Rhythm SUTDS ee een EEEE Ea ei aia
37. the user to develop a habit of recharging the battery before the unit indicates a low battery condition That 15 reduced depth of discharge Battery life varies by how the battery 15 maintained and how much it is used For improved battery life keep the electrocardiograph plugged in when not in use The sealed lead acid battery will provide optimum life when the unit 15 fully charged after each use The ELI 230 will charge a depleted battery to 85 of its capacity in approximately 6 hours or less 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 1 Open writer door 2 Lightly rub print head with an alcohol pad 3 Wipe with a clean cloth to remove alcohol residue 4 Allow print head to air dry 5 Clean the platen by using adhesive tape Apply the tape and pull it off Rotate roller and repeat until entire roller is clean 30
38. tically set to Off To turn the interpretation setting back On requires the user to make a manual change in the configuration setting AC Filter The ELI 230 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 15 present check to see that the proper AC filter is selected 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 a 300 Hz plot filter setting will not filter the printed ECG The filter setting 15 printed at the bottom right corner of the ECG printout 25 SECTION 4 Paper Speed Configure to 25 mm s or 50 mm s for default ECG printouts Rhythm Paper Speed Configure to 5 mm s 10 mm s 25 mm s or 50 mm s Interpretation Option The ELI 230 automatically analyzes ECGs and prints the optional interpretation on the ECG printout 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 physician over read as well as consideration of all other relevant patient data
39. ttery charging 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 also help prolong battery life Low Battery Conditions To prevent permanent damage to the internal lead acid battery the device will automatically power down when the battery has been depleted to its lowest allowable level When the device detects that the battery voltage has been depleted to this level it will display the messages Battery Low Charge Unit for 10 seconds before shutting down Plugging in the AC cord during this time will cause the unit to return to the main acquisition screen If the device is in the ECG acquisition mode when the battery voltage is detected at its lowest allowable level the unit will display the message Battery Low Charge Unit but will not automatically shutdown until the user exits the ECG acquisition mode This allows the user to complete an ECG already in progress 13 SECTION 2 Setting Date and Time l 2 Select MORE from real time ECG view Select CONFIG Select 3 Set Time Date The preprogrammed date and time 15 displayed To make changes to the date and time values using a 24 hour clock in the same format as displayed use and V to move back and forth through each row Use to select the year month day hour or minute Use 10 or 10 along with
40. used for the AMI2 acquisition module Once the USB memory stick 1s connected the device will automatically start transferring all existing records to the USB memory stick The device will display the message ECG TRANSFER IN PROGRESS Upon completion another message will display confirming the number of records transferred TRANSFERRED 20 20 DONE remove USB stick The device will automatically return to the real time ECG display when the USB memory stick has been removed All successfully transferred ECG records will have been cleared from the device NOTE Not all USB memory sticks may fit the device s USB port NOTE If the device appears to be unresponsive hold the Off key for 10 to 15 seconds to reboot Deleting Records To delete all existing patient records from the ELI 230 e Select MORE followed by CONFIG e Select application 4 Service followed by Yes e Select application 3 Clear all ECG Records Once selected a series of dots will start to appear on the display This signals to the user that the records are being deleted Once the deletion process 1s completed the display will return to the main configuration screen e Select DONE to return to the real time ECG display 21 22 SECTION 3 SYSTEM SETTINGS SECTION 4 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
41. vel 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the equipment including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance a 3 5 JP 3Vrms 4 5 WP 80 MHz to 800 MHz 3V m 4 n P 800 MHz to 2 5 GHz 3V m Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radios AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the equipment is used exceeds the applicable RF compliance level above the equipment should be observed to verify normal operation If abnorm
42. vice produce brittle lead wires and cables corrode the metal and void the warranty Use care and proper procedure whenever cleaning or maintaining the device 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 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 acceptable 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 recommended separation distances between the radio equipment and the device The use of accessories transducers and cables other than those specified by Mortara Instrument may result in increased emissions or decreased immunity of the equipment ELECTROMAGNETIC COMPATIBILITY EMC Table X 1 Guidance and Manufacturer s Declaration Electromagnetic Emissions The equipment is intended for use in the electromagnetic environment speci
43. wer supply To remove mains power from the unit disconnect the power supply cord from the appliance inlet e The device is UL classified DST FLe E U 2 WITH RESPECT TO ELECTRIC SHOCK FIRE AND MECHANICAL GV L US HAZARDS ONLY IN ACCORDANCE WITH UL2601 1 IEC60601 1 5P35 CAN CSA CC22 2 No 601 1 AND IEC60601 2 25 vill EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation Attention consult accompanying documents Alternating current Protective earth le GE gt r Defibrillator proof type CF applied part ON OFF power Do not dispose as unsorted municipal waste Per European Union Directive 2002 96 requires separate handling for waste disposal according to national requirements Antenna lt x Indicates compliance to applicable European Union directives M M 0459 1X GENERAL CARE Precautions e Turn off the device before inspecting or cleaning e Do not immerse the device in water e 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 e Verify that all cords and connectors are securely seated e Check the case and chassis for any visible damage e Inspect cords and connectors for any visible damage e Inspect keys and controls for proper function and appearanc
44. will rarely need to use the configuration screens again To access the configuration menus 2 Select MORE from real time ECG view Select CONFIG Select 1 to print the configuration settings Select 2 to enter the Modify Configuration menu Use A and V to move back and forth through each row Use to select the setting Use PAGE to advance to the next page of settings Select DONE to save any changes and exit the Modify Configuration menu Select DONE to return to real time ECG view 23 SECTION 4 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 ID Format AC Filter None Short Sex Age or Sex DOB None 50 or 60Hz Filter 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 Auto print ECG Yes or No Display Format 4 4 or 6 6 Plot Format Standard or Cabrera 6 12 or 3 1 channel 12 Rhythm leads l II III aVR aVL aVF V1 V2 V3 V4 V5 V6 6 Rhythm Leads 1 thru 6 II HI aVR aVL aVF V1 V2 V3 V4 V5 V6 in any combination 3 Rhythm Leads 1 thru 3 l II HI
45. y perspective per IEC 60601 1 and derivative standards norms this device is declared to be Class I and uses a three prong inlet to ensure an earth connection is made along 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 This device is intended to be used in a hospital or doctor s office setting and should be used and stored according to the environmental conditions specified below Operating temperature 10 to 40 C 4505 to 104 F Operating humidity 10 to 95 RH non condensing Storage temperature 40 to 70 C 40 to 158 F Storage humidity 10 to 95 RH non condensing Atmospheric pressure 500 hPa to 1060 hPa WAM wireless acquisition module must be paired to electrocardiograph before operation Device must be configured at the factory for use with the WAM After operating the device using battery power always reconnect the power cord This ensures that the batteries will be automatically recharged for the next time you use the device A light next to the on off switch will illuminate indicating that the device is charging This light will turn off when the battery is fully charged Vil USER SAFETY INFORMATION e The power supply cord and appliance inlet serve as the means to disconnect the unit from the mains po
46. y store up to 20 ECGs in its internal memory however the ECG records must be transferred via USB memory stick to a PC running ELI Link to be reviewed Starting with 20 and counting down to 0 the device will display the number of remaining storage slots available just below the display sweep speed on the right side of the display in acquired ECG view Once the device has stored 18 records 2 storage slots remaining a red box will appear around the countdown number If set to Yes in the configuration menu a storage warning message will appear in the center of the display on real time ECG view to notify the user that maximum storage is about to be reached Once maximum storage 15 reached the device will automatically delete the oldest record to make room for the new record first in first out The user can also enter the Service menu and delete all patient records at any time or transfer all the ECG records to a USB memory stick See Transfer to a USB Memory Stick 19 SECTION 3 Acquiring Rhythm Strips Rhythm strips are printed in the format defined in the configuration 3 6 or 12 channel See Section 4 for instructions to configure rhythm leads Begin routine rhythm strips by connecting the patient to the ELI 230 and entering the patient data Once completed select DONE to return to the real time ECG view Select RHY to begin rhythm printing You can also acquire a rhythm printout by selecting RHY without entering the patient data NOT
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