Mediana D500 Service Manual

Other manuals for D500: Operator's Manual
Manual is about: Defibrillator/Monitor

Summary of D500

  • Page 1

    Service manual defibrillator/monitor d500 eu representative obelis s.A bd. Général wahis, 53, 1030 brussels, belgium local distributor manufacturer mediana co., ltd. 132, donghwagongdan-ro, munmak-eup, wonju-si, gangwon-do, korea tel: (82) 2 542 3375 (82) 33 742 5400 fax: (82) 2 542 7447 (82) 33 742...

  • Page 2

    Directive copyright law allows no part of this instruction manual to be reproduced without permission. The content of this manual are subject to change without notice. The contents of this manual should be correct. If, for some reason, there are any questionable points, please do not hesitate to con...

  • Page 3: Contents

    I contents safety information .................................................................................................................................. 1 general safety information .................................................................................................................

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    Ii controls ........................................................................................................................................ 123 alarms .......................................................................................................................................... 1...

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    Iii figures figure 1. Front panel components .......................................................................................................... 8 figure 2. Top panel components ........................................................................................................... 10 figu...

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    Iv figure 56. Biphasic waveforms at 4 joules ........................................................................................ 146 figure 57. Biphasic waveforms at 3 joules ........................................................................................ 147 figure 58. Biphasic wavefor...

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    V tables table 1. The defibrillator/monitor controls on front panel ........................................................................ 9 table 2. The defibrillator/monitor controls on paddle ............................................................................ 10 table 3. Panel and labe...

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    Vi this page is intentionally left blank..

  • Page 9: Safety Information

    1 safety information general safety information this section contains important safety information related to general use of the defibrillator/monitor. Other important safety information appears throughout the manual. The defibrillator/monitor may be referred to as the defibrillator/monitor througho...

  • Page 10

    2 defibrillator/monitor without authorization. Do not use power source other than the specified voltage, (100- 240v~50/60hz) as this may cause fire or electric shock. Pre-use inspection and preventive maintenance must be performed for safe use. The defibrillator/monitor may be used with electrical s...

  • Page 11

    3 not connect more than one defibrillator/monitor to a patient. The defibrillator/monitor is a prescription device and is to be operated by qualified personnel only. As with any medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. Nev...

  • Page 12

    4 cable connectors. Securely attach cable connectors to the simulator. Do not touch the patient or any equipment connected to the patient during defibrillation. Warn all persons around patient to stay away prior to defibrillation. The defibrillator/monitor should be out of contact with water (puddle...

  • Page 13

    5 manual overview this manual contains information for servicing the d500 defibrillator/monitor. The d500 defibrillator/monitor will be referred to as the defibrillator/monitor throughout this manual. The defibrillator/monitor is subsequently referred to as the defibrillator/monitor throughout this ...

  • Page 14

    6 indications for use indications contraindications manual defibrillation manual defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for tr...

  • Page 15

    7 indications contraindications oxygen saturation and pulse rate. Disease and severe anemia (decreased hemoglobin). Invasive blood pressure invasive pressure monitor is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using and invasive catheter system ...

  • Page 16

    8 defibrillator / monitor controls front panel components figure 1. Front panel components 1 paddle 17 mic 2 nibp connector 18 mode select knob 3 lcd 19 analyze button 4 temperature1 connector 20 charge button 5 temperature2 connector 21 energy level button 6 ibp1 connector 22 shock button 7 ibp2 co...

  • Page 17

    9 table 1. The defibrillator/monitor controls on front panel symbols description mode select knob selects five modes of operation. (pacing, manual, monitor, off and aed) analyze button analyzes the patient’s ecg to determine whether or not to deliver a shock. Charge button charges to the desired ene...

  • Page 18

    10 top panel components figure 2. Top panel components 1 paddle 4 shock button 2 energy level button 5 charge button 3 rec button table 2. The defibrillator/monitor controls on paddle symbols description charge button charges to the desired energy level automatically. Energy level button selects the...

  • Page 19

    11 rear panel components figure 3. Rear panel components 1 smps/battery push button 5 ac power supply (smps) 2 dc input connector 6 speaker 3 ac power inlet 7 li-ion battery 4 gnd terminal 3 4 5 6 7 1 2.

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    12 left panel components figure 4. Left panel components right panel components figure 5. Right panel components 1 side option case 1 wireless(3g, wi-fi) module 2 usb/sd card slot 1 2 1.

  • Page 21

    13 table 3. Panel and label symbols symbols description symbols description ac indicator dust and water resistance direct current ce mark battery charging status indicator prescription only device service indicator follow instructions for use type bf- defibrillator proof separate collection type cf-...

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    14 this page is intentionally left blank..

  • Page 23: Routine Maintenance

    15 routine maintenance do not spray or pour any liquid on the defibrillator/monitor or its accessories. Do not immerse the defibrillator/monitor or its accessories in liquid or clean with caustic or abrasive cleaners. Cleaning the defibrillator/monitor may be surface-cleaned by using a soft cloth da...

  • Page 24

    16 batteries if the defibrillator/monitor has not been used for a long period of time, more than 6 months, the battery will need charging. To charge the battery, connect the defibrillator/monitor to an ac outlet as described in the battery charge paragraph in this service manual or the battery opera...

  • Page 25: Performance Verification

    17 performance verification general this section discusses the tests used to verify performance following repairs or during routine maintenance. All tests can be performed without removing the defibrillator/monitor covers. All tests except the battery charge and battery discharge tests must be perfo...

  • Page 26

    18 performance tests the battery charge and battery discharge test should be performed before defibrillator/monitor repairs whenever the battery is suspected as being a source of problems. All other tests may be used following repairs or during routine maintenance (if required by your local institut...

  • Page 27

    19 battery ” appears before the monitor powers down due to the low battery condition. 6. Verify that low priority audible alarm occurs and a alarm message “ low battery ” is displayed about 15 minutes before battery fully discharges. 7. Allow defibrillator/monitor to operate until it automatically p...

  • Page 28

    20 pads/paddle connection test test if the defibrillator/monitor detects the condition of pads/paddle connection. System rom test test if the rom reads data in normal. System ram test test if the ram reads and writes data in normal. Real time clock test test if the rtc chip for real time data operat...

  • Page 29

    21 alarm volume control 1. Connect the defibrillator/monitor to an ac power source. 2. Rotate the mode select knob to monitor mode to turn on the defibrillator/monitor. 3. Connect spo 2 simulator to sensor input cable and connect cable to defibrillator/monitor. 4. Set spo 2 simulator as follows: spo...

  • Page 30

    22 13. Press the multi function knob to save the desired volume. 14. Press return soft key. Verify the beep sound is increased. 15. Set the beep volume level from 7 to 0. 16. Verify the alarm sound is decreased. Button volume control 1. Connect the defibrillator/monitor to an ac power source. 2. Rot...

  • Page 31

    23 voice prompt volume control 1. Connect the defibrillator/monitor to an ac power source. 2. Rotate the mode select knob to monitor mode to turn on the defibrillator/monitor. 3. Select the setup menu by pressing the soft key and the setup menu will be displayed. 4. Rotate the multi function knob to...

  • Page 32

    24 4. Rotate the multi function knob to highlight volume and then press the knob to select volume menu. 5. Rotate the multi function knob to select pacing alarm menu, and if the button menu is highlighted, press multi function knob . 6. Speaker icon is activated. 7. Rotate the multi function knob to...

  • Page 33

    25 restoring power-on default settings the following test procedures will verify that alarms are activated at the level of factory default alarm limits and that any changed settings are saved and in effect when the user changes alarm limit settings in service menu. Figure 7. Parameter default settin...

  • Page 34

    26 6. Set print on alarm, print on charge, print on shock, print on mark, print on bp, print on self-test, 12 lead auto printing and analyze auto printing to on . 7. Press save soft key then select yes to save the setting. 8. Turn off the defibrillator/monitor. 9. Rotate the mode select knob to moni...

  • Page 35

    27 18. Test #6: 12 lead auto printing a. Connect ecg 12 lead cable to the defibrillator/monitor. B. Connect the ecg 12 lead cable to appropriate terminals on the ecg simulator. C. Press 12 lead soft key and then press acquire soft key. D. Verify that the defibrillator/monitor automatically prints ou...

  • Page 36

    28 defibrillator operation tests pacing mode 1. Connect the defibrillator/monitor to an ac power source. 2. Turn on the analyzer and press pacer button. 3. Set the analyzer as follows: brand: default algorithm load: 50 Ω 4. Connect pads connector to defibrillator/monitor’s front panel. 5. Contact pa...

  • Page 37

    29 manual mode 1. Connect the defibrillator/monitor to an ac power source. 2. Turn on the analyzer and press defibrillator button. 3. Set the analyzer as follows: brand: default algorithm load: 50 Ω 4. Press f1 button 3 times to enter to the waveform selection mode in the analyzer and select vfib wa...

  • Page 38

    30 measurement parameter operation tests ecg operation 1. Connect the defibrillator/monitor to an ac power source. 2. Rotate the mode select knob to monitor mode to turn on the defibrillator/monitor. 3. Connect the ecg 3 lead cable to appropriate terminals on the ecg simulator. 4. Connect the ecg ca...

  • Page 39

    31 11. Set ecg lead selection to lead ii. 12. Change ecg waveform size to all the selectable sizes and verify that an appropriate size is displayed on the ecg waveform area. 13. Disconnect 3 ecg leads and connect 5 ecg leads. 14. Verify that waveform setting menu displays i, ii, iii, avr, avl, avf, ...

  • Page 40

    32 note: in the nibp test mode , function buttons will have no effect except the multi function knob . All the tests will start to be performed by pressing or rotating the multi function knob . If you would like to stop the test during test progressing, press the multi function knob . Note: inflatio...

  • Page 41

    33 air leakage test the air leakage test verifies the integrity of the pneumatic system. Figure 9. Air leakage test 1. Ensure the defibrillator/monitor is set up with dummy can-large. 2. Connect the cuff to the nibp connector on the defibrillator/monitor’s front panel via nibp cuff hose. 3. Rotate t...

  • Page 42

    34 inflation time measurement figure 10. Inflation time measurement 1. Ensure the defibrillator/monitor is set up with the dummy can-large. 2. Ensure nibp test screen is active on the defibrillator/monitor, then select inflation time measurement menu using multi function knob . 3. Press multi functi...

  • Page 43

    35 deflation rate measurement figure 11. Deflation rate measurement 1. Ensure the defibrillator/monitor is set up with the dummy can-small. 2. Ensure nibp test screen is active on the defibrillator/monitor, then select deflation rate measurement menu using multi function knob . 3. Press multi functi...

  • Page 44

    36 criterion is 197 to 203 bpm. C. The defibrillator/monitor will display: - 90 % spo 2 - 200 bpm - alarm: “ high heart rate/pulse rate limits violated ” message will display and the hr/pr area will flash, indicating pulse rate is above default high alarm limit (medium priority alarm). D. Press puls...

  • Page 45

    37 breaths per minute. Note: the accuracy of respiration rate measurements is ±1 breaths per minute. In the procedure above, add the tolerance of the simulator to the acceptable range of readings. Note: the respiration measure function does not operate if pads or paddles are connected to the defibri...

  • Page 46

    38 ‐ display systolic, mean, diastolic measurement values on the ibp numerical area. Note: initial values of ibp simulator are systolic 120mmhg, diastolic 80mmhg at channel 1, systolic 120mmhg, diastolic 0mmhg at channel 2. Capnography operation note: the recommended capnostat5 co 2 sensor should be...

  • Page 47

    39 4. Test #2: flow rate accuracy a. Connect the sidestream co 2 module into the co 2 connector on the defibrillator/monitor’ front panel. B. Attach the sidestream sampling lime to the inlet port located on the metal container on the front of the co 2 module. You will hear a click when properly inse...

  • Page 48

    40 sfc: single fault condition / rm: reverse mains/lines voltage note: earth leakage current is measured under various conditions of the ac mains and protective earth conductor. For each condition, the measured leakage current must not exceed that indicated in table 5. Enclosure leakage current this...

  • Page 49

    41 note: this test requires a test cable for each patient connector. For example, the ecg test cable consists of the ecg cable connector, with all conductors shorted together, connected to a test lead from the electrical safety analyzer. Test cables for spo 2 and temperature can be configured in a s...

  • Page 50

    42 table 8. Patient leakage current values - mains voltage on applied part test condition allowable leakage current (microamps) type bf type cf normal polarity (sfc) 5000 50 reverse polarity (sfcrm) 5000 50 patient auxiliary current this test measures patient auxiliary current in accordance with iec...

  • Page 51

    43 table 10. Allowable leakage current test condition allowable leakage current (microamps) type bf type cf normal condition (nc) 100 10 sfc open supply (os) 500 50 sfc open earth (sfc oe) 500 50 normal condition rm (ncrm) 100 10 sfc open supply rm (sfc osrm) 500 50 src open earth rm (sfc oerm) 500 ...

  • Page 52

    44 verification check sheet record the results of the performance verification on this sheet. Model name serial no. Software version date tester items results remarks performance test power pass / fail battery charge pass / fail battery discharge pass / fail manual self-test -high-voltage module ali...

  • Page 53

    45 items results remarks performance test -deflation rate measurement pass / fail pulse oximetry operation - spo 2 90 ± 2% pass / fail value: % - pulse rate 200 ± 3bpm (high priority alarm condition) pass / fail value: bpm - pulse rate 60 ± 3bpm pass / fail value: bpm - modulation level pass / fail ...

  • Page 54

    46 safety test test conditions limit(ua) results remarks patient auxiliary current ecg la-temp (sfc oe) 50 pass / fail value: ua patient auxiliary current ecg la-temp (ncrm) 10 pass / fail value: ua patient auxiliary current ecg la-temp (sfc osrm) 50 pass / fail value: ua patient auxiliary current e...

  • Page 55

    47 service menu and parameter default settings general this section discusses use of the service menu to configure system setting, printer setting, parameter default setting, ecg setting, shock setting, aed mode setting, 3g network setting and wi-fi network setting. Also this section explains briefl...

  • Page 56

    48 figure 13. Entering the pass code note: the pass code is 0, 0, 0 . It is factory default setting. 5. Rotate the multi function knob to highlight the top of the digits. Press the multi function knob to enter pass code. 6. Rotate the multi function knob until “ 0 ” appears, then press the multi fun...

  • Page 57

    49 system setting i figure 14. System setting i table 11. System setting i system setting i level1 level2 level3 software information return software update main software start, return display software start, return analog software start, return voice prompt start, return return parameters color ecg...

  • Page 58

    50 system setting i level1 level2 level3 audio pause time 90 sec 120 sec return audio off time 3 min 5 min 10 min return alarm reminder tone off 3 min 10 min return alarm active at power up enable disable service menu data save service menu data start return load service menu data start return auto ...

  • Page 59

    51 audio pause time pressing the alarm button temporarily off alarms for the period selected in this menu. The factory default of alarm off period is 30 seconds. Audio off time if pressing and holding the alarm button for 2 seconds, alarm is not activated during set time interval through this menu. ...

  • Page 60

    52 system setting ii figure 15. System setting ii table 12. System setting ii system setting ii level1 level2 level3 auto self-test self-test time 0 ~ 23 ‘ clock self-test interval off 24 hours 48 hours 72 hours return internal shock energy 0~10j return clinical action list 1 ~ 10 none, cpr, epi, at...

  • Page 61

    53 system setting ii level1 level2 level3 device id confirm return 12 lead institution name confirm return 12 lead location code confirm return communication phone numbers confirm return manual mode protection enable confirm password return manual mode locking passcode pass number 1 pass number 2 pa...

  • Page 62

    54 device installation id device installation id can be entered in this menu. Device id device id can be entered in this menu. 12 lead institution name 12 lead institution name can be entered in this menu. 12 lead location code 12 lead location code can be entered in this menu. Communication phone n...

  • Page 63

    55 printer setting figure 16. Printer setting table 13. Printer setting printer setting level1 level2 level3 print on alarm on off print on charge on off print on shock on off print on mark on off print on bp on off print on self-test on off 12 lead auto printing on off analyze auto printing on off ...

  • Page 64

    56 information before and after 10 seconds when a shock is generated. Print on mark if print on mark is set to on , the defibrillator/monitor will automatically print out when clinical action list is selected in setup menu. Print on bp if print on bp is set to on , the defibrillator/monitor will aut...

  • Page 65

    57 parameter default setting level1 level2 level3 airway (high limit) : 1~150 impedance (low limit) : 3~119 airway (low limit) : 0~149 return resp on/off on off power on waveform select 1st waveform i, ii, iii, pads 2nd waveform i, ii, iii, pads, spo 2 , resp, ibp1, ibp2, etco 2 , return 3rd wavefor...

  • Page 66

    58 parameter default setting level1 level2 level3 (1.3 to 32.6 kpa) (5 mmhg, 0.6 or 0.7kpa steps) adult/pedi (low limit): 10 to 245 (mmhg) 1.3 to 32.6 (kpa) neonatal (low limit): 25 to 85 mmhg (3.3 to 12.0 kpa) (5 mmhg, 0.6 or 0.7kpa steps) return nibp inflate pressure adult/pedi: 120 mmhg adult/ped...

  • Page 67

    59 parameter default setting level1 level2 level3 0.0 to 49.9 °c (32.0 to 121.8 °f) (0.1°c, 0.1° or 0.2°f steps) return temp unit °c °f ibp alarm limit p1 sys(high limit): -45 to 300 mmhg (-6 to 40 kpa) (5 mmhg, 0.6 or 0.7kpa steps) p1 sys(low limit): -50 to 295mmhg (-6.7 to 39.3 kpa) (5 mmhg, 0.6 o...

  • Page 68

    60 parameter default setting level1 level2 level3 (-6.7 to 39.3 kpa) (5 mmhg, 0.6 or 0.7kpa steps) return ibp unit mmhg kpa ibp1 label p1 abp return ibp2 label p2 cvp pap lap return etco 2 alarm limit etco 2 (high limit): 1 to150 mmhg (0.13 to 20.0 kpa), (0 to 20.0 %) (1 mmhg, 0.13 kpa, 0.13 % steps...

  • Page 69

    61 spo 2 alarm limit the custom-default spo 2 alarm limit can be set in this menu. Nibp alarm limit the custom-default nibp sys, map, dia alarm limit can be set in this menu. Nibp inflate pressure the custom-default nibp inflate pressure can be selected as 120, 140, 160, 180, 200, 220, 240, 260 or 2...

  • Page 70

    62 ibp1 label the ibp1 label can be selected as p1 or abp in this menu . Ibp2 label the ibp2 label can be selected as p2, cvp, pap or lap in this menu . Etco 2 alarm limit the custom-default etco 2 and inco 2 can be set in this menu. Etco 2 unit the custom-default etco 2 unit can be selected as mmhg...

  • Page 71

    63 ecg setting figure 18. Ecg setting table 15. Ecg setting ecg setting level1 level2 level3 ac line filter 50 hz 60 hz off pacer detection enable disable ecg size x 0.5 x 1 x 1.5 x 2 x 3 return ecg filter 0.5 hz - 21 hz 0.05 hz - 40 hz 1 hz - 21 hz return message display enable disable ac line filt...

  • Page 72

    64 ecg filter the filter bandwidth frequency for ecg signal display can be set to 0.5hz ~ 21hz or 0.05hz ~ 40hz or 1hz~21hz . Message display if message display is set to enable , defibrillator/monitor sets ecg waveform message to display. 12 lead ecg setting figure 19. 12 lead ecg setting table 16....

  • Page 73

    65 12 lead ecg setting level1 level2 level3 12 lead print speed 25mm/s 50mm/s auto transmit if the auto transmit is set to on , the reading result of 12 lead ecg signal is sent by 3g or wi-fi. Print on 12 lead measurement if the print on 12 lead measurement is set to on , the each results of 12 lead...

  • Page 74

    66 shock setting figure 20. Shock setting table 17. Shock setting shock setting level1 level2 level3 elapsed time display enable disable cpr guide display enable disable message display on off voice prompt enable disable basic auto energy escalation enable disable above 200j setting enable disable m...

  • Page 75

    67 elapsed time display if elapsed time display is set to enable , the elapsed time of defibrillator/monitor operation is displayed on the main screen each mode. Cpr guide display if cpr guide display is set to enable , the cpr guide is displayed in the manual mode. Message display if message displa...

  • Page 76

    68 aed mode setting figure 21. Aed mode setting table 18. Aed mode setting aed mode setting level1 level2 level3 setup menu enable disable alarm limit menu enable disable 12 lead menu enable disable aed display setting waveform display enable disable icon display enable disable value display enable ...

  • Page 77

    69 setup menu if setup menu is set to enable , setup soft key menu is enabled in aed mode. Alarm limit menu if alarm limit menu is set to enable , alarm limit soft key menu is enabled in aed mode. 12 lead menu if 12 lead menu is set to enable , 12 lead soft key menu is enabled in aed mode. Aed displ...

  • Page 78

    70 pacing mode setting figure 22. Pacing mode setting table 19. Pacing mode setting pacing mode setting level1 level2 level3 fixed pacing on off pace pulse rate 30~180bpm return default pacing energy 0 ma 30 ma 70 ma 100 ma 140 ma return fixed pacing if fixed pacing is set to on , the defibrillator/...

  • Page 79

    71 3g network setting figure 23. 3g network setting table 20. 3g network setting configuration menu – 3g network setting level1 level2 level3 3g on off destination ip address destination port usim1 enable disable apn authentication protocol none pap chap authentication id authentication password usi...

  • Page 80

    72 usim1, usim2 usim for 3g network connection can be set in this menu. Apn ssid for 3g network connection can be set in this menu. Authentication protocol authentication protocol for 3g network connection can be set in this menu. Authentication id authentication id for 3g network connection can be ...

  • Page 81

    73 configuration menu – wi-fi network setting level1 level2 level3 wireless security mode none wep wpa wpa2 eap return wep key length 64bit (10 hex digits) 128 bit (26 hex digits) shared key confirm return wi-fi wi-fi is set to on or off on this menu. Ip configuration ip address, subnet mask and gat...

  • Page 82

    74 factory default settings service menu factory defaults parameter ranges and parameter default settings in service menu are divided into 2 groups, adult/pediatric and neonatal as described in table 22. Parameter ranges and factory defaults. The patient mode is preset to “adult/pediatric” mode. Ala...

  • Page 83

    75 parameter ranges / selections (adjust step) factory defaults (5 mmhg, 0.6 or 0.7kpa steps) nibp sys low alarm limits adult/pediatric 30 to 265 mmhg (4.0 to 35.3 kpa) neonatal 40 to 125 mmhg (5.3 to 16.7 kpa) (5 mmhg, 0.6 or 0.7kpa steps) adult/pediatric 90 mmhg (12.0 kpa) neonatal 40 mmhg (5.3 kp...

  • Page 84

    76 parameter ranges / selections (adjust step) factory defaults (-6.7 to 39.3 kpa) (5 mmhg, 0.6 or 0.7kpa steps) (5.3 kpa) ibp 1 mean high alarm limits adult/pediatric -45 to 300 mmhg (-6 to 40 kpa) (5 mmhg, 0.6 or 0.7kpa steps) adult/pediatric 90 mmhg (12.0 kpa) ibp 1 mean low alarm limits adult/pe...

  • Page 85

    77 parameter ranges / selections (adjust step) factory defaults (0.13 to 2.7 kpa), (0.13 to 2.6 %) (1 mmhg, 0.13 kpa, 0.13 % steps) (2.7 kpa), (2.6 %) inco 2 low alarm limits adult/pediatric 0 to 19 mmhg (0 to 2.5 kpa), (0 to 2.5 %) (1 mmhg, 0.13 kpa, 0.13 % steps) adult/pediatric 0 mmhg (0 kpa), (0...

  • Page 86

    78 parameter ranges / selections (adjust step) factory defaults print on bp** on, off off print on self-test** on, off on 12lead auto printing** on, off on analyze auto printing** on, off off elapsed time display* enable, disable enable cpr guide display* enable, disable enable message display* enab...

  • Page 87

    79 parameter ranges / selections (adjust step) factory defaults 0096fa, fa00fa, 96fa32, c8c8c8, 0096c8, c89600, c8c832 parameters color - nibp* 00fa00(green), fafafa(white), 64fafa(cyan), 6464fa(light blue), fa96fa(pink), fa0000(red), fafa00(yellow), 9696c8(light purple), fa9600, 0096fa, fa00fa, 96f...

  • Page 88

    80 parameter ranges / selections (adjust step) factory defaults demerol, oral glu, lasix, calcium manual mode protection* disable, confirm, passcode disable manual mode locking passcode* 000~999 (passcode) pacing mode protection* disable, confirm, passcode disable pacing mode locking passcode* 000~9...

  • Page 89: Software Update

    81 software update general this section is for the purpose for reloading software into the defibrillator/monitor when the possibility of corrupted software exists, or updating software with a new system revision (system/device version). Call mediana technical service department for the latest versio...

  • Page 90

    82 7. Choose software update menu and then select main software menu or analog software menu or display software menu or voice prompt menu. In main software menu, the main cpu software for various parameters can be updated. In display software menu, the software for screen display, alarm messages. I...

  • Page 91: Troubleshooting

    83 troubleshooting general this section provides information that can be helpful in troubleshooting the defibrillator/monitor. How to use this section if the defibrillator/monitor is not functioning properly, please check on the following items before calling for repair service. Use this section in ...

  • Page 92

    84 troubleshooting guide problems with the defibrillator/monitor are separated into categories for further troubleshooting instructions. Note: taking the recommended actions discussed in this section will correct the majority of problems you will encounter. However, problems not covered here can be ...

  • Page 93

    85 categories symptoms 11.3: poor ecg signal quality (noisy trace, wandering baseline, etc.) from signal acquired through paddles/pads. 11.4: solid flat line - no waveform, no lead off in operation. 11.5: ecg value or waveform does not display. 11.6: lead select button does not respond. 11.7: one or...

  • Page 94

    86 1. General symptom 1.1: the report data and customer settings are not saved. Checkpoint action remark cpu board replace cpu board. Main board replace main board. Note: if the report data were deleted in setup menu, the deleted data cannot be recovered. Symptom 1.2: the date and time printed on th...

  • Page 95

    87 symptom 2.2: battery is not charging. Checkpoint action remark battery 1. Connect ac power cord to check the ac/dc in led is lighted. 2. If ac/dc in led is lighted in step1, then replace battery. Service menu 1. Access to the service menu via setup menu. 2. Enter the pass code “2”,”3”,”1”. 3. Che...

  • Page 96

    88 symptom 2.7: the defibrillator/monitor does not turn on though external dc power is connected. Checkpoint action remark external dc module replace external dc module dc connector cable 1. If dc connector cable is disconnected, connect the cable properly. 2. If dc connector cable is cut, replace t...

  • Page 97

    89 4. Sound symptom 4.1: audio is too low or absent. Checkpoint action remark volume setting 1. Check volume setting. 2. Change to aed mode to check voice prompt sounds. Speaker cable 1. If the cables are disconnected, connect the cables properly. 2. If the cables are cut, change the cables. Speaker...

  • Page 98

    90 checkpoint action remark cable. Front board replace front board. Charger board replace charger board. Cpu board replace cpu board. Main board replace main board. 6. Nibp symptom 6.1: the cuff does not inflate. Checkpoint action remark battery status if the batter status is “low battery” or “criti...

  • Page 99

    91 8. Temperature symptom 8.1: temperature value does not display. Checkpoint action remark sensor connection check the connection of temperature sensor to the skin. Temperature module replace the temperature module. Cpu board replace cpu board. Main board replace main board. 9. Respiration symptom ...

  • Page 100

    92 symptom 11.2: poor ecg signal quality (noisy trace, wandering baseline, etc.) from signal acquired through monitoring electrodes. Checkpoint action remark electrodes connection with patient 1. Check that the monitoring electrodes are properly applied. If necessary, prepare the patient's skin and ...

  • Page 101

    93 symptom 11.5: ecg value or waveform does not display. Checkpoint action remark paddles/pads or leads 1. Check the pads, paddles or ecg cables are connected. 2. Check the pads, paddles, or monitoring electrodes are properly applied. 3. Check the desired lead is selected. Ecg board replace ecg boar...

  • Page 102

    94 13. Defibrillation and pacing symptom 13.1: pacing does not start. Checkpoint action remark pacing energy if pacing energy is set to 0ma, set the appropriate pacing energy. Pause key if pause key is pressed, press pause key again to cancel. Pacing rate in demand mode set the pacing rate appropria...

  • Page 103

    95 checkpoint action remark are connected. 2. Check the pads, paddles, or monitoring electrodes are properly applied. 3. Check the desired lead is selected. Hv connector cable 1. If the cable is disconnected, connect the cable properly. 2. If the cable is cut, change the cable. Hv board replace h/v ...

  • Page 104

    96 checkpoint action remark printing. 2. If dirt on printerhead, clean the printerhead. Printer mecha or control board replace printer mecha or control board. Charger board replace charger board. Symptom 14.4: loud buzzing or grinding noise. Checkpoint action remark printer cover latch printer cover...

  • Page 105

    97 error codes conditions eee261 spo 2 module packet crc error eee262 spo 2 module end of packet missing eee263 spo 2 module packet contains undefined key eee264 spo 2 module corrupted variable eee265 spo 2 module memory overflow eee266 spo 2 module bad pointer eee267 spo 2 module parameter value ou...

  • Page 106

    98 error codes conditions eee907 rtc error* eee908 printer vp voltage or head temperature error eee910 speaker error note: an asterisk (*) by an error code explanation in the above table indicates that an audible alarm occurred by the error code cannot be silenced by pressing alarm button..

  • Page 107: Disassembly Guide

    99 disassembly guide performance verification. Do not place the defibrillator/monitor into operation after repair or maintenance has been performed, until all performance tests and safety tests listed in performance verification section of this service manual have been performed. Failure to perform ...

  • Page 108

    100 2 d 500 2 figure 26. Disassembly sequence flow chart replacement level supported the replacement level supported for this product is to the printed circuit board (pcb) and major subassembly level. Once you isolate a suspected pcb, follow the procedures in disassembly guide, to replace the pcb wi...

  • Page 109

    101 side option case disassembly (a) this section describes the items that may be removed on the side option case assembly. Figure 27. Side option case disassembly (1) table 26. Part descriptions – side option case disassembly (1) part codes descriptions p1239 parameter pcb p1249 parameter link pcb ...

  • Page 110

    102 figure 28. Side option case disassembly (2) table 27. Part descriptions – side option case disassembly (2) part codes descriptions a0366 nibp hose e4114 nibp cuff connector (eu/ap/jp) e4232 nibp cuff connector (us) p1072 ibp pcb p1239 parameter pcb p1240 temp pcb p1241 etco 2 pcb p1242 temp conn...

  • Page 111

    103 a3. Temp pcb disassembly 1. Remove 3 screws (3 × 4, s8072) on the parameter pcb (p1239). 2. Disconnect temp connector cable (w0495) from parameter pcb (p1239). 3. Remove temp connector cable (w0495) from side option connector (t0618). 4. Separate temp pcb (p1240) from parameter pcb (p1239). A3. ...

  • Page 112

    104 front case disassembly (b) this section describes the items that may be removed on the front case disassembly. Figure 29. Front case disassembly (1) table 28. Part descriptions – front case (1) part codes descriptions e9030 speaker p1233 main pcb p1236 hv pcb s8020 screw 3 × 8 (tapping) t0598 fr...

  • Page 113

    105 b1. Front case disassembly 1. Disconnect hv power cable (w0491) from hv pcb (p1236). 2. Disconnect charger power cable (w0490) from main pcb (p1233). 3. Disconnect hv data cable (w0461) from main pcb (p1233). 4. Disconnect charger data cable (w0492) and speaker cable (e9030) from main pcb (p1233...

  • Page 114

    106 figure 30. Front case disassembly (2) table 29. Part descriptions – front case (2) part codes descriptions m0007 spo 2 module m0015 nibp module p1176 cpu pcb p1233 main pcb p1245 ecg pcb s8007 screw 3 × 6 s8020 screw 3 × 8 (tapping) s8072 screw 3 × 4 s8099 screw 2.5 × 5 t0598 front case t4313 ni...

  • Page 115

    107 part codes descriptions w0469 printer cable 1 (4pin, ref: p1233-rj1, m4065-cn1) w0470 printer cable 2 (5pin, ref: p1233-rj2, m4065-cn2) w0486 spo 2 pi cable w0488 front cable 1 (15pin, ref: p1233-uj3, p1234-j3) w0489 front cable 2 (25pin, ref: p1233-uj2, p1234-j4) w0497 3g / wi-fi cable (20pin, ...

  • Page 116

    108 figure 31. Front case disassembly (3) table 30. Part descriptions – front case (3) part codes descriptions p1234 front pcb p1243 knob pcb s8020 screw 3 × 8 (tapping) t0536 lcd window t0598 front case b7. Front pcb disassembly 1. Remove 4 screws (3 × 8, s8020) fastening front pcb (p1234) and fron...

  • Page 117

    109 figure 32. Front case disassembly (4) table 31. Part descriptions – front case (4) part codes descriptions m4065 thermal printer module m4066 printer mecha s8013 screw 2 × 6 s8020 screw 3 × 8 (tapping) t0598 front case t0601 printer case w0469 printer cable 1 (4pin, ref: p1233-rj1, m4065-cn1) w0...

  • Page 118

    110 rear case disassembly (c) this section describes the items that may be removed on the rear case disassembly. Figure 33. Rear case disassembly (1) table 32. Part descriptions – rear case (1) part codes descriptions m0039 wi-fi module m0057 3g module m4074 3g antenna m4075 wi-fi antenna p1246 3g i...

  • Page 119

    111 figure 34. Rear case disassembly (2) table 33. Part descriptions – rear case (2) part codes descriptions e9030 speaker m2027 hv capacitor p1236 hv pcb p1237 charger pcb p1244 battery connector pcb s8007 screw 3 × 6 s8020 screw 3 × 8 (tapping) t0599 rear case t0600 inner case t4395 capacitor brac...

  • Page 120

    112 c2. Hv capacitor disassembly 1. Remove 2 machine screws (3 × 6, s8007) fastening capacitor bracket (t4395) and inner case (t0600). 2. Disconnect hv connector cable (w0375) from hv board (p1236). 3. Separate hv capacitor (m2027) from inner case (t0600). C3. Hv pcb disassembly 1. Remove 6 tapping ...

  • Page 121

    113 figure 35. Paddle mounting plate disassembly table 34. Part descriptions – paddle mounting plate part codes descriptions a0418 paddle a0419 d500 paddle adult ass’y (left and right) m4078 paddle mounting resistor s8007 screw 3 x 6 s8075 screw 3 × 6 (flat head) t0599 rear case t0607 paddle mountin...

  • Page 122

    114 part codes descriptions t4397 paddle ground w0514 paddle mounting cable c8. Paddle mounting plate disassembly 1. Remove 4 flat head screws (3 × 6, s8075) on the rear case (t0599). 2. Separate paddle mounting plate (t0607) from rear case (t0599). 3. Remove 2 screws (3 × 6, s8007) from paddle moun...

  • Page 123

    115 figure 36. Ac power supply (smps) disassembly table 35. Part descriptions – ac power supply (smps) part codes descriptions m0055 d500 ac power supply (smps) module s8020 screw 3 × 8 (tapping) t0599 rear case t0605 ac power supply (smps) case top t0606 ac power supply (smps) case bottom w0398 ac ...

  • Page 124

    116 figure 37. D500 exploded view.

  • Page 125: Spare Parts

    117 spare parts follow local government ordinances and recycle instructions regarding disposal or recycling of device components, including batteries. General spare parts, along with part numbers, are shown in table 36. Part list. Obtaining replacement parts mediana technical service department prov...

  • Page 126

    118 table 36. Part list item part code description 1 t0645 rubber stopper 2 e4114/e4232 nibp cuff connector (eu/ap/jp) / nibp cuff connector (us) 3 t0618 side option connector 4 w0153 ibp connector cable 1 (4pin) 5 w0154 ibp connector cable 2 (5pin) 6 w0450 etco 2 cable (8pin) 7 t0620 side option co...

  • Page 127

    119 item part code description 53 t0601 printer case 54 m4066 thermal printer mecha 55 t0602 printer door 56 t0627 mode knob 57 p1243 mode knob pcb 58 p1234 front pcb 59 t0642 shock button 60 t0634 led membrane 61 t0597 front case deco 62 t0638 front membrane (5key) 63 t0639 front membrane (7key) 64...

  • Page 128

    120 this page is intentionally left blank..

  • Page 129: Packing For Shipment

    121 packing for shipment general instructions to ship the defibrillator/monitor for any reason, follow the instructions in this section. Pack the defibrillator/monitor carefully. Failure to follow the instructions in this section may result in loss or damage not covered by the mediana warranty. Prio...

  • Page 130

    122 repacking in a different carton if the original carton is not available, use the following procedure to pack the defibrillator/monitor: 1. Place the defibrillator/monitor in a plastic bag. 2. Locate a corrugated cardboard shipping carton with at least 200 pounds per square inch (psi) bursting st...

  • Page 131: Specification

    123 specification display screen size 8.4” measured diagonally across the tft-lcd screen screen type liquid crystal display (lcd) color size 170 x 128 mm number of traces 4 waveforms controls standard multi function knob; mode select knob (off, aed, manual, pacing and monitor); 11 buttons (shock, en...

  • Page 132

    124 electrical instrument power requirements ac mains 100 to 240 v, 50/60 hz, 120 - 130va dc mains 18vdc, 7.0a with dc/dc adapter, model:mdd150-1218 (mdd150-1218: input: 12-16vdc, 160 - 160va, output: 18vdc, 7.0a) note: for 120 volt applications, use only ul listed detachable power cord with nema co...

  • Page 133

    125 environmental conditions operation temperature 0 to 50°c (32 to 122°f) humidity 15 to 95% rh, non-condensing altitude -170 to 4,877m (-557 to 16,000 ft) note: the system may not meet its performance specifications if stored or used outside the specified temperature and humidity range. Note: the ...

  • Page 134

    126 tone definition high priority alarm tone volume level adjustable (level 1~8) pitch (± 48.8hz) 976 hz pulse width (± 10ms) 210 ms number of pulses 10 pulses per 4 sec, 10 sec inter burst repetitions continually medium priority alarm tone volume level adjustable (level 1~8) pitch (± 34.85hz) 697 h...

  • Page 135

    127 measurement parameters pacing mode pacing mode pacing rate variable from 30 bpm(ppm) to 180 bpm(ppm) ± 1.5% (increments or decrements by a value of 2 bpm(ppm)) resolution 2 bpm(ppm) accuracy ± 1.5 % output current 0 ma to 140 ma resolution 2 ma accuracy ± 5% or 5 ma, whichever is greater. Pulse ...

  • Page 136

    128 ecg heart rate measurement range 0, 20 to 300 bpm resolution 1 bpm accuracy ± 10% or ±5 bpm, whichever is greater average response time 5 seconds (from 80 to120 bpm) 9 seconds (from 80 to 40 bpm) tall t-wave rejection maximum t-wave amplitude 1.8 mv ecg (electrocardiograph) leads 3 / 5 / 12 lead...

  • Page 137

    129 time to alarm for tachycardia vent tachycardia 1 mvpp, 206 bpm: amplitude 0.5mv, alarm activated time 6.79 sec amplitude 1mv, alarm activated time 9.80 sec amplitude 2mv, alarm activated time 8.19 vent tachycardia 2 mvpp, 195 bpm: amplitude 1mv, alarm activated time 3.43 sec amplitude 2mv, alarm...

  • Page 138

    130 nibp pulse rate pulse rate range adult/pediatric 40 to 200 bpm neonatal 40 to 240 bpm resolution 5 bpm pulse rate accuracy ±2 bpm or ±2%, whichever is greater nibp (non-invasive blood pressure) technique oscillometric measurement measurement modes off, cont, 1, 2.5, 3, 5, 10, 15, 30, 60, 90 minu...

  • Page 139

    131 ibp pulse rate pulse rate range 20 to 250 bpm accuracy ± 1 % or ± 1 bpm pulse rate resolution 1 bpm ibp (invasive blood pressure) parameter displayed p1, abp p2, cvp, pap, lap measurement range -50 mmhg to 300 mmhg 20 bpm to 250 bpm resolution 1 mmhg accuracy ± 3 mmhg input sensitivity 5µv/v/mmh...

  • Page 140

    132 capnography capnography parameter displayed etco 2 , inco 2 range 0 mmhg ~ 150 mmhg (0kpa ~ 20kpa, 0% ~ 20%) accuracy 0-40mmhg ±2mmhg of reading 41-70mmhg ±5% of reading 71-100mmhg ±8% of reading 101-150mmhg ±10% of reading (no degradation due to respiration rate or inspiration/expiration ratio ...

  • Page 141

    133 temperature thermistor temp probe type ysi 400 series and ysi 700 series probes measurement method thermistor operating mode direct range 0 to 50°c (32.0 to 122°f) display accuracy ±0.1 probe accuracy ysi 400 series and ysi 700 series probes: ±0.1°c from 25 to 45°c, ±0.2°c from 0 to 25°c and fro...

  • Page 142

    134 defibrillator (technical specification) aed mode aed mode charging time - 200j charging condition time (sec) with rated mains voltage 5.8 with dc mains voltage 5.9 with fully charged battery 6.4 charging time - 200j (including time from the initiation of rhythm analysis with a clear ecg signal t...

  • Page 143

    135 manual mode manual mode charging time – 200j charging condition time (sec) with rated mains voltage 5.8 with dc mains voltage 5.9 with fully charged battery 6.4 with mains voltage of 90% of the rated value 5.8 with dc mains voltage of 90% of the rated value 6.4 after 15 maximum energy discharges...

  • Page 144

    136 ambient temperature is above 200 times for 360j and 250 times for 200j ecg analysis performance rhythm class aha-db mit-db cu-db vf-db total number of sample size vf-shockable: tp 1013 22 280 915 2230 vf-shockable: fn 47 0 11 70 128 vf-shockable: sensitivity(%) 95.57 100.00 96.22 92.89 94.57 vt-...

  • Page 145

    137 biphasic waveform characteristics the efficiency of mediana’s biphasic waveform has been clinically verified during a ventricular fibrillation (vf) and ventricular tachycardia (vt) defibrillation study. This study (which was conducted using d500 defibrillator/monitors) and the findings are descr...

  • Page 146

    138 figure through show the biphasic waveforms that are produced when the defibrillator/monitor is discharged into loads of 25, 50, 75, 100, 125, 150 and 175 ohms at each energy setting (360, 300, 200, 175, 150, 125, 100, 75, 50, 40, 30, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3,2 and 1 joule[s]). The vertica...

  • Page 147

    139 figure 41. Biphasic waveforms at 175 joules figure 42. Biphasic waveforms at 150 joules.

  • Page 148

    140 figure 43. Biphasic waveforms at 125 joules figure 44. Biphasic waveforms at 100 joules.

  • Page 149

    141 figure 45. Biphasic waveforms at 75 joules figure 46. Biphasic waveforms at 50 joules.

  • Page 150

    142 figure 47. Biphasic waveforms at 40 joules figure 48. Biphasic waveforms at 30 joules.

  • Page 151

    143 figure 49. Biphasic waveforms at 20 joules figure 50. Biphasic waveforms at 10 joules.

  • Page 152

    144 figure 51. Biphasic waveforms at 9 joules figure 52. Biphasic waveforms at 8 joules.

  • Page 153

    145 figure 53. Biphasic waveforms at 7 joules figure 54. Biphasic waveforms at 6 joules.

  • Page 154

    146 figure 55. Biphasic waveforms at 5 joules figure 56. Biphasic waveforms at 4 joules.

  • Page 155

    147 figure 57. Biphasic waveforms at 3 joules figure 58. Biphasic waveforms at 2 joules.

  • Page 156

    148 figure 59. Biphasic waveforms at 1 joules.

  • Page 157

    149 compliance item standard description classification iec60601-1:1988 +a1:1991+a2:1995, en60601-1:1990+a1:1993 /ac:1994 class i (on ac power) internally powered (on battery power) type of protection iec60601-1:1988 +a1:1991+a2:1995, en60601-1:1990+a1:1993 /ac:1994 type bf and type cf – applied par...

  • Page 158

    150 item standard description iso 10993-1:2009/ cor1:2010, en iso109931:2009 /ac:2010 biological evaluation of medical devices – part 1: evaluation and testing iso10993-5:2009, en iso10993-5:2009 biological evaluation of medical devices – part 5: tests for in vitro cytotoxicity iso10993-10:2010, en ...

  • Page 159

    151 item standard description sphygmomanometers iec60601-2-30:1999, en60601-2-30:2000 particular requirements for the safety, including essential performance, of automatic cycling indirect blood pressure monitoring equipment oxygen saturation iso9919:2005, en iso 9919:2009 basic safety & essential p...

  • Page 160

    152 item standard description frequency equipment rf emissions group 1, class b cispr22:2008 information technology equipment - radio en55022:2010/ac:2011 disturbance characteristics - limits and methods of measurement package ista (procedure 1a, 2001) pre-shipment test procedures (package) iec60068...

  • Page 161

    153 system processing description system overview the d500 is a defibrillator and multi-function monitor. Manual and automated external defibrillation, external pacing and the other monitoring functions (electrocardiography (ecg), functional arterial oxygen saturation(spo 2 ), respiration(resp), tem...

  • Page 162

    154 unit description power unit: consists of power entry module, power supply, battery charger, battery, external dc input and dc/dc unit. Figure 61. Power unit block diagram main process unit: consists of samsung s3c2440a arm9 cpu, sdram and flash. Figure 62. Main process unit block diagram.

  • Page 163

    155 display unit: consists of samsung s3c2440 cpu, sdram and flash. Figure 63. Display unit block diagram user-control unit: consists of multi function knob, 16 functional button, ac/dc indicator led and battery charging status indicator led. Figure 64. User-control unit block diagram audio unit: 3-...

  • Page 164

    156 communication unit : 8-channel uart figure 66. Communication unit block diagram gui (graphic user interface) unit: consists of tft lcd, inverter for backlit and internal video controller. Figure 67. Gui unit block diagram thermal printer unit: prints data records. Figure 68. Thermal printer unit...

  • Page 165

    157 nibp unit: measures non-invasive blood pressure data. Figure 69. Nibp unit block diagram etco 2 unit: measures etco 2 data. Figure 70. Etco 2 unit block diagram ecg, respiration and defibrillation unit: measures electrocardiographic waveform data. Figure 71. Ecg unit block diagram.

  • Page 166

    158 spo 2 unit: measures oxygen saturation data figure 72. Spo 2 unit block diagram temperature unit: measures temperature data. Figure 73. Temperature unit block diagram ibp unit: measures invasive blood pressure waveform data. Figure 74. Ibp unit block diagram external interface sd card : sd type ...

  • Page 167

    159 ecg processing the measurement of the skin surfaces electrocardiogram is based on the electrical signals on the skin surface, produced as the heart muscle contracts and relaxes. The signals are detected by electrodes placed on the patient body. The information on heart activity carried by these ...

  • Page 168

    160 systole systole map distole map distole distole map s ysto le time time ● oscillometric response (pressure pulses) ● cuff pressure overall accuracy discussion overall system accuracy shall be determined by considering various influences of the pressure sensor accuracy, motion artifacts, other ar...

  • Page 169

    161 spo 2 processing pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photodetector. Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates ...

  • Page 170

    162 automatic calibration because light absorption by hemoglobin is wavelength dependent and because the mean wavelength of leds varies, an oximeter must know the mean wavelength of the spo 2 sensor’s red led to accurately measure spo 2 . During monitoring, the instrument’s software selects coeffici...

  • Page 171

    163 respiration processing the respiration monitoring is designed to use the variation of this thoracic impedance. The chest contains various materials, ranging from bone to air. Each of these materials has different electrical properties and is located in a different portion of the chest. The mater...

  • Page 172

    164 invasive blood pressure processing the pressure transducer is connected to a pressure line which, by means of a catheter is invasively connected to the patient blood stream. The force of movement of the blood in the patient vessels in transported by the fluid column in the pressure line to the t...