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APPENDIX B

 

 

44 

 

Содержание ELI 10 Rx

Страница 1: ...ENG Rev C1 ELI 10 Rx 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 orde...

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

Страница 3: ...plies Accessories Mortara Instrument Inc 7865 North 86th Street Milwaukee WI 53224 U S A Tel 414 354 1600 Fax 414 354 4760 Hospital Customers orders us mortara com Physician Practice orderspc us morta...

Страница 4: ...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...

Страница 5: ...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...

Страница 6: ...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...

Страница 7: ...ting 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 i...

Страница 8: ...verse effect of electric currents than healthy persons All equipment that is connected to the patient can be touched by the patient or can be touched by another person while that person touches the pa...

Страница 9: ...o operate keys on the keyboard To help avoid possible fatigue and related stress injuries do not exert excessive force when pushing keys or continuously operate the device using the same finger and ha...

Страница 10: ...or 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 unspe...

Страница 11: ...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 0 to 40 C 32...

Страница 12: ...g in a failed transmission When this occurs patient data will not be erased from the device nor stored in the receiving application ensuring that partial or corrupted data are not made available to th...

Страница 13: ...12 2467 MHz 2454 5 MHz 2479 5 MHz 13 2472 MHz 2459 5 MHz 2484 5 MHz 14 2484 MHz 2471 5 MHz 2496 5 MHz In order to achieve the best transmission rate it is necessary that the facility where the device...

Страница 14: ...USER SAFETY INFORMATION xii...

Страница 15: ...on consult accompanying documents Alternating current Protective earth Fuse Telephone line modem Network LAN Defibrillator proof type CF applied part ON OFF power Shift key to enter upper case text Sp...

Страница 16: ...iv Do not dispose as unsorted municipal waste Per European Union Directive 2002 96 requires separate handling for waste disposal according to national requirements Antenna Indicates compliance to appl...

Страница 17: ...ed by the APIC Guidelines for Selection and Use of Disinfectants 4 Use caution with excess liquid as contact with metal parts may cause corrosion 5 Do not immerse cable ends or lead wires immersion ca...

Страница 18: ...GENERAL CARE xvi...

Страница 19: ...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 ac...

Страница 20: ...is used in such an environment 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 Flo...

Страница 21: ...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 fr...

Страница 22: ...imum 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 4...

Страница 23: ...Specifications 7 Accessories 8 EQUIPMENT PREPARATION SECTION 2 Section Purpose 9 Connecting the Patient Cable 9 Charging the ELI 10 Rx 9 Setting Time Date and LCD Contrast 10 RECORD AN ECG SECTION 3 S...

Страница 24: ...AND MAINTENANCE APPENDIX A ECG Record Errors 37 Capturing ECG Errors 37 ECG Transmission Errors 37 Battery Errors 38 Password Errors 38 Configuration Errors 38 General Errors 38 Printing Errors 39 US...

Страница 25: ...cardiac patients Indications for Use The ELI 10 Rx is indicated for use in a clinical setting by qualified medical professionals only for recording ECG data of patients The device is indicated for us...

Страница 26: ...nder specific criteria If this option is enabled see Section 6 the VERITAS algorithm can provide an over reading physician with a silent second opinion through diagnostic statements output on the ECG...

Страница 27: ...r printer C Phone line connector for optional modem D AC power inlet E Green LED indicating power on F Flashing yellow LED indicating LAN connection NOTE Two AC line fuses are installed on your ELI 10...

Страница 28: ...l display LCD 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 not active If a function key is not...

Страница 29: ...for display 5 mm mV 10 mm mV or 20 mm mV Gain is displayed in the top center portion of the display screen to the right of speed Filter Use F5 Filt to select the filter setting for display and printin...

Страница 30: ...when the ELI 10 is properly docked in the docking station This message disappears once the ELI 10 is removed If the device is not properly docked Attention ELI 10 not properly docked is displayed unt...

Страница 31: ...r printer speed only Gain Setting 5 10 or 20 mm mV Report Print Formats Standard or Cabrera 3 3 1 3 3 6 6 6 or 12 channel Special Functions Optional Mortara VERITAS resting ECG interpretation with age...

Страница 32: ...040 51 Patient cable 10 lead wire detachable banana IEC 9293 039 50 Patient cable without lead wires 9325 001 50 Alligator clip adapter 4 mm set of 10 9281 002 50 Banana clip to snap lead wire 4 mm s...

Страница 33: ...y docked will appear If this happens gently push the ELI 10 Rx into the docking station to ensure it is properly seated If the device states DOCKED vs DOCKED AC verify the power indicator on the front...

Страница 34: ...date and time values using a 24 hour clock in the same format as displayed Use F1 and F2 to move back and forth through each row TIP Use the backspace key BKSP to erase entry errors 4 LCD contrast ca...

Страница 35: ...their muscles are relaxed 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 p...

Страница 36: ...electrodes on flat fleshy parts of the arms and legs 3 Place the electrodes on the inside of each arm between the wrist and elbow 4 Place the electrodes on the inside of each calf between the ankle a...

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

Страница 38: ...ace at the left sternal border Green Green Midway between V2 C2 and V4 C4 electrodes Blue Brown On the 5 th intercostal space at the left midclavicular line Orange Black Midway between V4 C4 and V6 C6...

Страница 39: ...reen Use F1 to navigate by line down the directory list use Shift F1 to move up Similarly use F2 to page down the directory list use Shift F2 to page up To quickly select a patient name use the keyboa...

Страница 40: ...d I and II artifact Poor RA electrode Lead I and III artifact Poor LA electrode V Leads Re prep site replace electrode NOTE LCD label functions are not available during acquisition Press AUTO The real...

Страница 41: ...splay and the printout is the same what is displayed in the ECG acquisition view is what will be printed Use F4 Interp to select and view the measurements followed by F5 More to view the interpretive...

Страница 42: ...SECTION 3 18...

Страница 43: ...ternational calling codes See Appendix B for the country code list To transmit records from real time ECG view select XMT To transmit one ECG use F2 Selec to choose a record from the ECG directory Use...

Страница 44: ...ity option is factory installed Please note that for GSM GPRS mobile transmission the SIM card must have voice and data capabilities enabled and security options cell phone lock must be disabled Order...

Страница 45: ...ormation is designed in ELI LINK or an E Scribe system and downloaded to the ELI 10 Rx Using the keyboard select 4 Custom ID Download from the application menu Attempting Network Connection followed b...

Страница 46: ...ss any key to continue The total number of ECGs transmitted to USB memory will also appear Transferring Batch Patient ECG Data to the USB Place the ELI 10 Rx securely into the docking station Place th...

Страница 47: ...lect 1 and display the ECG directory list Management of the ECG record is performed within the directory of stored ECGs The desired record must be highlighted in order to view edit add demographics or...

Страница 48: ...t the ECG records select F5 More from the ECG directory Select F1 to sort the directory by patient name patient ID and time date of the highlighted ECG are displayed on the top row Select F2 to sort t...

Страница 49: ...ation 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 will rarely need to use the co...

Страница 50: ...ard or custom optional Auto Fill ID Yes or No AC Filter None 60 Hz or 50 Hz Plot frequency Filter 40 Hz 150 Hz or 300 Hz LCD ECG Speed 5 10 25 or 50 mm sec Height Weight Units lb in or kg cm Date Form...

Страница 51: ...XX WLAN MAC XX XX XX XX XX XX Access Point Name GPRS Mobile Text see Appendix C Access Point User Name Text Access Point Password Text Worklist Management Standard or Refresh Comm Protocol UNIPRO or D...

Страница 52: ...ephone number with GSM GPRS mobile connectivity TIP To quickly delete or modify a phone number use a shortcut From the application screen simultaneously press SHIFT ALT P To edit an existing number us...

Страница 53: ...om ID format can be downloaded from the E Scribe system See Section 4 to download a custom ID The short format includes the patient s last name followed by the first name patient ID number date of bir...

Страница 54: ...not be reduced by proper procedures LCD ECG Speed Defines the speed in which the ECG will be presented on the display To manually set the speed select F3 and this will toggle you between 5 10 25 or 50...

Страница 55: ...d from the directory when they are marked for deletion and if the directory becomes full More than one ECG may be removed from the directory in order to make room for the new incoming record The delet...

Страница 56: ...Comm Media to LAN in the configuration setup It is necessary that the IT Manager of your facility set the ELI 10 Rx LAN configuration values NOTE Addresses are always entered as 4 sets of 3 digits the...

Страница 57: ...ed Host IP Enter the IP address of the host server NOTE Addresses are always entered as 4 sets of 3 digits therefore an address of 192 168 0 7 must be entered on the ELI 10 Rx as 192 168 000 007 Port...

Страница 58: ...on your access point then set security WEP to NO If WEP security is enabled on your access point then the following wireless network parameters must be configured in the device by the IT Manager Secu...

Страница 59: ...p to 64 characters Access Point Name The access point name can contain up to 64 characters GSM GPRS Mobile Transmission U S vs non U S may differ For a GSM GPRS transmission set the Comm Media to GSM...

Страница 60: ...the IT Manager of the facility where the device is installed Owner Name Option currently not available Multi Protocol Configuration Site Number Second and Third site as well The ELI 10 Rx allows for t...

Страница 61: ...No telephone number found in configuration Enter correct phone number into configuration and attempt to transmit again Can t Connect to Access Point Configuration access points do not match access po...

Страница 62: ...customer service Password Errors LCD MESSAGE RESOLUTION Tech Password Compare Error Ensure correct password entry in both locations Admin Password Compare Error Ensure correct password entry in both...

Страница 63: ...r Error Ensure printer has paper cable is connected and unit is powered on No Paper Ensure printer has paper Printer Offline Ensure printer is powered on USB Errors LCD MESSAGE RESOLUTION NO USB MEMOR...

Страница 64: ...ns and protective earth Battery Maintenance The ELI 10 Rx houses an internal lithium ion battery Operating time on a full battery charge ECG acquisition only approximately 8 hours Maximum time to full...

Страница 65: ...uba CU B5 Australia AU 09 Cyprus CY FD Austria AT FD Czech Republic CZ FD Azerbaijan AZ B5 Denmark DK FD Bahamas BS B5 Djibouti DJ B5 Bahrain BH B5 Dominica DM B5 Bangladesh BD B5 Dominican Republic D...

Страница 66: ...D Jamaica JM B5 New Caledonia NC B5 Japan JP 00 New Zealand NZ 7E Jordan JO B5 Nicaragua NI B5 Kazakhstan KZ B5 Niger NE B5 Kenya KE B5 Nigeria NG B5 Kiribati KI B5 Niue NU B5 Korea Democratic People...

Страница 67: ...n Islands British VG B5 Singapore SG 9C Virgin Islands U S VI B5 Slovakia SK FD Wallis and Futuna Islands WF B5 Slovenia SI FD Western Sahara EH B5 Solomon Islands SB B5 Yemen YE B5 Somalia SO B5 Yugo...

Страница 68: ...APPENDIX B 44...

Страница 69: ...ers AT T internet com Chile Entel PCS imovil entelpcs cl bam entelpcs cl Chile Telefonica GSM web tmovil cl China China Mobile cmnet Croatia VIPNET gprs vipnet hr Czech Republic Eurotel internet Czech...

Страница 70: ...telgprs com Indonesia Telkomsel internet Ireland O2 internet Ireland Vodafone live vodafone com Israel Cellcom internetg Israel Orange internet Italy TIM uni tim it ibox tim it Italy Vodafone Omnitel...

Страница 71: ...rsinternet Singapore M1 sunsurf Singapore Singtel internet Singapore Starhub shwapint Slovakia Eurotel internet Slovakia Orange internet South Africa MTN internet Spain Amena amenawap Spain Telefonica...

Страница 72: ...obile com UK Virgin goto virginmobile uk UK Vodafone UK internet UK Orange orangeinternet Ukraine Kyivstar GSM www kyivstar net Ukraine UMC www umc ua USA T Mobile internet2 voicestream com USA AT T p...

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