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Mortara Instrument ELI 25O, Руководство пользователя

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User Safety Information 

(Continued)

• Excessive patient movement could interfere with the operation of the device.

• Proper patient preparation is 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, are used

simultaneously with the ELI 250; however, disturbance to the signal may occur.

• If the ECG amplifier input is out of normal operating range, the display will indicate a lead fail for the

lead(s) where this condition is present and if the signal is 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:

• Class I equipment or internally powered
• Type CF applied parts
• Ordinary equipment
• Not suitable for use in the presence of flammable anesthetics
• Continuous operation

NOTE:

From a safety perspective, per IEC 60601-1 and derivative standards / norms, this unit

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 unit. Exposed metal accessible during normal operation is double insulated from mains.
Internal connections to earth ground are functional earth.

• The ELI 250 will automatically turn off (blank screen) if the batteries have been severely discharged and

the AC mains is disconnected from the unit.

• After operating the ELI 250 using battery power, always reconnect the power cord. This ensures that the

batteries will be automatically recharged for the next time you use the ELI 250. A light will illuminate,
next to the on/off switch, indicating that the unit is charging. This light will turn off when the battery is
fully charged.

• The ELI 250 is a UL Classified Device:

WITH RESPECT TO ELECTRIC SHOCK, 
FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE 
WITH UL2601-1, IEC60601-1, CAN/CSA CC22.2 No. 601.1, 
AND IEC60601-2-25

vi

Notes

5P35

Содержание ELI 25O

Страница 1: ...RESTING ELECTROCARDIOGRAPH REF 9515 163 50 ENG Rev F1 Manufactured by Mortara Instrument Inc Milwaukee Wisconsin U S A CAUTION Federal law restricts this device for sale to or on the order of a physic...

Страница 2: ...mation 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 Mort...

Страница 3: ...h Street Milwaukee WI 53224 Tel 414 354 1600 Tel 800 231 7437 Fax 414 354 4760 Internet http www mortara com Europe Economic Community Representative Mortara Rangoni Europe Srl European Headquarters I...

Страница 4: ...e 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 reserve...

Страница 5: ...e or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara and ii all risk of loss in transit It is expressly agreed that the liability of Mor...

Страница 6: ...r defibrillation protection Patient cables should be checked for cracks or breakage prior to use Conductive parts of the patient cable electrodes and associated connections of Type CF applied parts in...

Страница 7: ...nnected equipment network cable shielding must be connected to protective earth ground appropriate to the area where the ELI 250 is used The ELI 250 has not been designed for use with high frequency H...

Страница 8: ...a safety perspective per IEC 60601 1 and derivative standards norms this unit is declared to be Class I and uses a three prong inlet to ensure an earth connection is made along with mains The ground t...

Страница 9: ...lt accompanying documents Alternating current Protective earth ground Fuse Telephone line modem Network LAN Defibrillator proof type CF applied part Output Transmit Input ON OFF power Stop of action E...

Страница 10: ...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...

Страница 11: ...iguration 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...

Страница 12: ...ins power quality should be that of a typical IEC 61000 4 5 mode 2 kV mode 2 kV commercial or hospital environment common mode common mode Voltage dips short 5 UT 5 UT Mains power quality should be th...

Страница 13: ...system b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m ELECTROMAGNETIC COMPATIBILITY EMC Continued xi Emissions Test IEC 60601 Test Level Compliance Level Electr...

Страница 14: ...or 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 wh...

Страница 15: ...2 1 Equipment Set Up 2 1 Battery Fuse 2 1 Load Paper 2 2 A4 Paper 2 3 Apply Power 2 5 Set Time Date 2 5 Patient Preparation 2 7 Patient Hookup 2 7 Real Time ECG View 2 8 SYSTEM SETTINGS SECTION 3 Cha...

Страница 16: ...X A Chapter Purpose A 1 Transmitting Records A 1 Direct Connection A 3 Modem Transmission A 3 Modem Initialization A 3 Modem Country Codes A 4 Blind Dialing for Xircom Modems A 5 External Modem A 6 WL...

Страница 17: ...a licensed physician It is not intended as a sole means of diagnosis The interpretations of ECG data by the device are only significant when used in conjunction with physician over read as well as con...

Страница 18: ...c statements output on the ECG report For additional information on the Mortara VERITAS resting interpretation algorithm please refer to the Physician s Guide to ECG Interpretation Multiple print form...

Страница 19: ...ft Side Figure 1 2 Left Side View ELI 250 Rear Figure 1 3 SECTION 1 1 3 Writer Cover Handle Input Connector Patient Cable Connector AC Powercord Connector Modem Connector Optional AC Fuses Serial Conn...

Страница 20: ...SECTION 1 ELI 250 Base Figure 1 4 1 4 Cart Mounting Battery Fuse ECG Imput...

Страница 21: ...CD label adjacent to each function key LCD labels functions change depending upon the screen displayed If the label is blank the adjacent function key is deactivated Automatic Feature Keys are used as...

Страница 22: ...ory storage of ECGs Paper Type Full size 8 5 x 11 or A4 Z fold thermal paper 250 sheets stored in paper tray Thermal Recorder Computer controlled dot array 8 dots mm Thermal Writer Speeds 5 10 25 or 5...

Страница 23: ...the user with Equipment set up procedures Load paper Apply power Set date and time Patient preparation and hook up Real Time ECG View Equipment Set Up Two AC line fuses and one battery fuse are insta...

Страница 24: ...in 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...

Страница 25: ...If units are purchased with standard paper the paper tray spacer will not be provided To insert the Paper Tray Spacer Slide paper tray spacer towards rear wall of writer tray Align the bottom four pl...

Страница 26: ...l with the rear wall of the writer tray as pictured above Gently press paper tray spacer in place Set configuration option to use A4 paper See section 3 for instructions Gently press on the top three...

Страница 27: ...ndicator will turn off when the battery is fully charged The electrocardiograph should be connected to AC power for recharging whenever the unit is not in use TIP Battery voltage is displayed at the b...

Страница 28: ...played Use F1 and F2 to move back and forth through each row TIP Use the BACKSPACE key to erase entry errors Select Save F5 to save changes before exiting Select Exit F6 to return to Real Time ECG Vie...

Страница 29: ...ed in an air tight container Electrodes will dry out if not stored properly which will cause loss of adhesion and conductivity Patient Hookup V1 Fourth Intercostal space at the right sternal border V2...

Страница 30: ...ation including waveform display function keys and parameters leadfail messages clock filter etc Detailed descriptions of the Real Time ECG View are offered in section 4 NOTE Regardless of the display...

Страница 31: ...change on a daily or patient to patient basis Once you set these default conditions you will rarely need to use the configuration screens again When you apply power to the ELI 250 it will operate acc...

Страница 32: ...ugh the configuration pages Use F1 and F2 to move back and forth through each configuration option Use F3 to toggle through pre programmed available settings per configuration field Use Exit F6 to ret...

Страница 33: ...creen Two Filter 40Hz 150Hz or 300Hz Screen Two Height Weight Units lb in or kg cm Screen Two Date Format US mm dd yyyy or European dd mm yyyy Screen Two Plot Format Channels printed 3 1 6 3 3 12 6 6...

Страница 34: ...Screen Five 3 3 Rhythm Lead 1 V1 V6 I II III aVR aVL aVF Screen Five 3 3 Rhythm Lead 2 V1 V6 I II III aVR aVL aVF Screen Five 3 3 Rhythm Lead 3 V1 V6 I II III aVR aVL aVF Screen Four Default XMT Media...

Страница 35: ...nate the hospital clinic or institution for ECG records stored in a Mortara Instrument E Scribe data management system and must be defined for transmitting and retrieving ECGs from the data management...

Страница 36: ...uration screen function labels are immediately translated If an unknown language is visible use the following steps to revert to the language of your country 1 F6 from Real Time ECG View 2 Select numb...

Страница 37: ...The short format includes the patient s last name and first name patient ID number date of birth which will automatically calculate the age and gender field The standard format includes the patient s...

Страница 38: ...filter is selected Paper Speed The writer speed can be configured at 25mm s or 50mm s for default ECG printouts For rhythm printouts and display speeds of 5mm s or 10mm s are also available See Secti...

Страница 39: ...performed or the interpretive statements selected by the analysis program For Example Anteroseptal Infarct 40 MS Q WAVE IN V1 V4 Where Anteroseptal Infarct is the interpretive statement And 40 MS Q W...

Страница 40: ...t Plot Transmit ECG is automatically marked deleted after transmission and printing Storage Sensitivity The ECG storage sensitivity setting dictates the resolution of the stored record The sensitivity...

Страница 41: ...pacer should not be inserted if the letter size paper is used Caps Lock All character entry is translated to upper case Configuration Page 4 Rhythm Formats Configuration page four defines the default...

Страница 42: ...for the 3 3 channel ECG printout Use F3 to make your selection of any of the 12 leads NOTE Rhythm acquisition is not stored in memory only printed NOTE See section 4 to acquire a rhythm printout Form...

Страница 43: ...CP This setting defines whether the Dynamic Host Communication Protocol DHCP will be used to obtain an IP address If DHCP is Yes the network will automatically and dynamically assign an IP address the...

Страница 44: ...to the same network must have the same SSID name This field is case sensitive Channel Number This defines the channel used by the radio to search for the network The exact channel number varies accord...

Страница 45: ...provide the 26 HEX digits that are the same to be used by all access points on the network Therefore only devices with the proper WEP will be able to login The ELI 250 adopts a 128 bit encryption Acc...

Страница 46: ...SECTION 3 3 16...

Страница 47: ...a lead fail occurs an indicator flashes in this location Speed Use Speed F3 to select one of the various options for display speed or rhythm printout speed 5mm s 10mm s 25mm s 50mm s NOTE ECG paper s...

Страница 48: ...ble waveform display formats by selecting Leads F2 Waveforms are displayed in the following formats 5 seconds of leads I II III 5 seconds of leads aVR aVL aVF 5 seconds of leads V1 V2 V3 5 seconds of...

Страница 49: ...ctured below NOTE If a Custom ID has been downloaded to the ELI 250 Custom demographic labels will appear as it was designed in your E Scribe data management system See Appendix A for more details Pat...

Страница 50: ...re found the existing data is used to fill some of the demographic fields The auto fill feature is designed to only automatically populate last name first name date of birth age and gender If no match...

Страница 51: ...workflow permits patient demographic entry prior to acquisition connect the patient to the ELI 250 and enter the patient identification information as explained above After you complete the last data...

Страница 52: ...eform formats by selecting Leads F2 A preview of the full 10 seconds of ECG waveform is available The first 5 seconds of waveforms are displayed page 1 2 is displayed in the upper right corner and by...

Страница 53: ...nfiguration setting select Fmt F4 The following function keys become available Select the function key corresponding to the desired print format The Acquired ECG View is then displayed and to make an...

Страница 54: ...e F5 and Save F5 in the Acquired ECG View Acquiring Rhythm Strips Rhythm strips are printed in the format defined in the configuration 3 channel 6 channel or 12 channel See section 3 for instructions...

Страница 55: ...l 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 1 Default user selected in configuration 2 I II III 3 aVR aVL aVF...

Страница 56: ...ses In order to map the function and feature keys of the electrocardiograph to a desired barcode font the following values and or symbols must be available NOTE the ELI software will ignore Enter carr...

Страница 57: ...g chart summarizes the application functions available Descriptions of the Applications are detailed later in this section following the summary chart Appendix A details the ELI 250 connectivity optio...

Страница 58: ...will automatically be highlighted An ECG may be listed in the directory but have a deleted status indicated by X The directory saves those records that have been marked for deletion in the event that...

Страница 59: ...Done F6 from the Acquired ECG View In order to change the speed gain filter or printout format in the Acquired ECG View select More F5 The function key labels change as depicted below To manipulate t...

Страница 60: ...ctory by acquisition date name is displayed on the top row To make a printout of the patient directory select Print Directory F4 The directory lists stored ECGs based on how you have the directory sor...

Страница 61: ...on 2 The configuration printout obtains every configuration setting for the specific cardiograph the firmware version the cart number of the unit and the date and time that the configuration printout...

Страница 62: ...layed Use F1 and F2 to move back and forth through each row TIP Use the BACKSPACE key to erase entry errors LCD contrast can be adjusted by selecting Lcd F3 or Lcd F4 Select Save F5 to save changes be...

Страница 63: ...with modem option only To transmit records either to another cardiograph to ELI LINK or to E Scribe select XMT The following screen is displayed To batch transmit of all records in the directory selec...

Страница 64: ...t F1 to move up the list Similarly use F2 to page down and Shift F2 to page up through the directory To quickly find and select a patient name use the keyboard to enter the first letter s of the last...

Страница 65: ...phone jack located on the back of the cardiograph and the other end into a telephone wall jack Confirm telephone number in the configuration settings see Section 3 of this manual Modem Initialization...

Страница 66: ...pplication Menu XIRCOM MODEM COUNTRY CODE LIST A 4 Hook Type Exit Send Configure MODEM Enter MODEM Command AT GCI XX Modem Type MultiTech Country Code Country Code Argentina 07 Liechtenstein 68 Austra...

Страница 67: ...country code string will be displayed Press F6 Exit MulitTech MODEM COUNTRY CODE LIST APPENDIX A A 5 Country Code Country Code Argentina 07 Italy FD Australia 09 Japan 00 Austria FD Korea B5 Belgium F...

Страница 68: ...Algeria 34 Cayman Islands 34 American Samoa 34 Central African Republic 34 Andorra 34 Chad 34 Angola 34 Chile 34 Anguilla 34 China 34 Antigua and Barbuda 34 Colombia 34 Argentina 34 Congo 34 Armenia 3...

Страница 69: ...See 34 Maldives 34 Vatican City State Honduras 34 Mali 34 Hong Kong 30 Malta 34 Hungary 30 Martinique 34 Iceland 34 Mauritania 34 India 30 Mauritius 34 Indonesia 30 Mayotte 34 Iran 34 Mexico 34 Iraq 3...

Страница 70: ...omania 34 Uganda 34 Russian Federation 34 Ukraine 34 Rwanda 34 United Arab Emirates 34 Saint Kitts and Nevis 34 United Kingdom 34 Saint Lucia 34 Uruguay 34 Saint Vincent and 34 USA 34 the Grenadines S...

Страница 71: ...ef Gateway Sub Net Mask If DHCP is set to YES your wireless access point will have an automatic network setting and IP Address Def Gateway and Sub Net Mask do not need to be configured In either DHCP...

Страница 72: ...d below CAUTION Possible damage to the cardiograph may occur if telephone cable is connected to the LAN connector Ethernet Status LEDs At the external LAN interface connector the user is presented wit...

Страница 73: ...the transmitting electrocardiograph Follow the instructions on transmitting records as described in this section The receiving unit only acts as a printer Received ECGs will not be viewed or stored T...

Страница 74: ...elect Retrieve ECGs 5 from the Application Menu The following screen appears NOTE The ID field defaults the last acquired ECG ECGs are retrieved by ID number Enter the desired ID and select F1 E Scrib...

Страница 75: ...ng to the Request Code Once downloaded the patient list for each Request Code is stored in the cardiograph as the Request List similar to the patient directory As with the other forms of ECG data tran...

Страница 76: ...1 and F2 to scroll through the available Request Codes Request Codes are only available if a Custom ID has been downloaded Once you find the desired Request Code Select F3 Selec to select the desired...

Страница 77: ...y Dialing telephone number Waiting for Response and Connected Once connected the following screen indicates the number of Requests received patients for the Request Code This only appears briefly and...

Страница 78: ...to the Patient Directory in looks and in practice The Patient Request List sorted by name is pictured below Similar to the Directory of stored ECGs the Patient Request List is easily sorted either by...

Страница 79: ...uest List and Shift F1 to move up the list Similarly use F2 to page down and Shift F2 to page up through the Request List To quickly select a patient name use the keyboard to enter the first letter of...

Страница 80: ...customized ECG header information is designed in the Mortara E Scribe data management system and downloaded to the ELI 250 as the Group Name either by serial connection direct or modem transmission Se...

Страница 81: ...mographic entry needs The Custom ID is only deleted upon downloading a new Custom ID or on the rare occasion of downloading software it will not be lost due to power loss or switching to a different I...

Страница 82: ...APPENDIX A A 20...

Страница 83: ...ead 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 V4 V5 V6 Correct faulty lead s TRANSMIT FAILED Unable to transmit ECG Check phone line Ins...

Страница 84: ...allow unintended access to internal electronics areas Cleaning the ELI 250 Disconnect the power source Clean the exterior surface of the unit with a damp cloth using a solution of mild dishwashing det...

Страница 85: ...The ELI 250 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...

Страница 86: ...APPENDIX B B 4...

Страница 87: ...lead Bipolar lead that represents the differences of electrical potential between two selected sites leads I II III Muscle noise Grossly uneven baseline caused by patient body tremor or other muscle...

Страница 88: ...GLOSSARY G 2...

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