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  5. Operator's Manual

Mediana D500 Operator's Manual

Other manuals for D500: Service Manual
Manual is about: Defibrillator/Monitor

Summary of D500

  • Page 1

    Operator’s 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 ...

  • 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 cont...

  • Page 3: Contents

    I contents contents .................................................................................................................................................... I safety information .................................................................................................................

  • Page 4

    Ii manual mode ......................................................................................................................................... 79 general ...........................................................................................................................................

  • Page 5

    Iii event ....................................................................................................................................................... 141 general .................................................................................................................................

  • Page 6

    Iv figures figure 1. Front panel components .............................................................................................................. 17 figure 2. Top panel components ..................................................................................................................

  • Page 7

    V figure 57. Connection for sidestream ....................................................................................................... 126 figure 58. Etco 2 display .......................................................................................................................... 127 ...

  • Page 8

    Vi tables table 1. The defibrillator/monitor controls ................................................................................................... 18 table 2. The defibrillator/monitor controls on paddle .................................................................................. 19 tab...

  • Page 9: Safety Information

    7 safety information general safety information this section contains important safety information related to general use of the d500 defibrillator/monitor. Other important safety information appears throughout the manual. The d500 defibrillator/monitor will be referred to as the defibrillator/monit...

  • Page 10

    8 do not open cover or disassemble this defibrillator/monitor. Doing so could cause electric shock or fire. It is prohibited by law to modify the defibrillator/monitor without authorization. Do not use power source other than the specified voltage, (100- 240v~50/60hz) as this may cause fire or elect...

  • Page 11

    9 wall socket. 2. Place an “out of order” sign on the defibrillator/monitor and do not use it. 3. Have the defibrillator/monitor serviced to make sure that no hazard exists. Do not connect more than one patient to the defibrillator/monitor. Do not connect more than one defibrillator/monitor to a pat...

  • Page 12

    10 clean the paddle electrode surfaces, handles, and storage area after defibrillation. A gel pathway on the skin between the standard paddles will cause defibrillating energy to arc between paddles and delivery energy away from the heart muscle. Do not allow conductive gel (wet or dry) to become co...

  • Page 13

    11 do not immerse any portion of this defibrillator in water or other fluids. Avoid spilling any fluids on defibrillator or accessories. Spilled liquids may cause the defibrillator and accessories to perform inaccurately or fail. Do not clean with ketones or other flammable agents. Do not autoclave ...

  • Page 14

    12 cautions caution statements identify conditions or practices that could result in damage to the equipment or other property. Always check that the defibrillator/monitor functions properly and is in proper condition before use. Federal law restricts this device to sale by or on the order of a phys...

  • Page 15: Introduction

    13 introduction patient conditions may result in erroneous readings. If the measurements are suspect, verify the reading using another clinically accepted measurement method. Intended use for the d500 the defibrillator/monitor is intended for use by trained medical technician, doctor, nurse or medic...

  • Page 16

    14 indications contraindications prevent tachycardia. Contraindicated and is contraindicated for use on neonates. Electrocardiography the 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection. No known contraindications...

  • Page 17

    15 about this manual this manual explains how to set up and use the defibrillator/monitor. Read the entire manual including the safety information section, before you operate the defibrillator/monitor. Identifying the d500 configurations the following table identifies d500 defibrillator/monitor conf...

  • Page 18

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  • Page 19

    17 description of the defibrillator/monitor 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 ...

  • Page 20

    18 table 1. The defibrillator/monitor controls 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 energy level auto...

  • Page 21

    19 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 22

    20 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.

  • Page 23

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

  • Page 24

    22 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-...

  • Page 25

    23 displays figure 6. Displays 1 shock count number/icon 8 title of waveform parameter 2 defibrillator message area 9 waveform area 3 battery status icon 10 waveform 4 elapsed time (power on) 11 alarm/informative message area 5 wi-fi/3g icon 12 numerical area 6 title of numeric area 13 date/time 7 e...

  • Page 26

    24 table 4. Display symbols symbols description symbols description ecg source: paddle temperature unit: celsius ecg source: lead l temperature unit: fahrenheit ecg source: lead ll spo 2 unit or etco 2 unit: % ecg source: lead lll respiration icon ecg source: lead avl nibp or ibp or etco 2 unit: mmh...

  • Page 27

    25 table 5. Display colors factory defaults function color ecg waveform green spo 2 waveform cyan respiration waveform light blue etco 2 waveform light purple ecg green nibp white spo 2 cyan respiration rate light blue etco 2 light purple temperature1 pink temperature2 pink ibp 1 red ibp 2 yellow ge...

  • Page 28

    26 this page is intentionally left blank..

  • Page 29

    27 setting up the defibrillator/monitor to ensure accurate performance and prevent defibrillator/monitor failure, do not expose the defibrillator/monitor to extreme moisture, including direct exposure to rain. Such exposure may cause inaccurate performance or device failure. Refer to specification s...

  • Page 30

    28 list of components the following items are standard in the package. Table 6. Standard accessories items qty d500 defibrillator/monitor 1 operat or’s manual 1 ac power cord 1 printer paper 2 defibrillation pads for adult 1 defibrillation pads for pediatric 1 pads extension cable 1 ecg 3 leads cabl...

  • Page 31

    29 optional items may be ordered if needed. Contact your local supplier for pricing and ordering information. Table 7. Optional accessories items qty paddle - defibrillation / external pacing pads for adult - defibrillation / external pacing pads for pediatric - nibp cuff for neonate - nibp cuff hos...

  • Page 32

    30 power cable connections do not connect to an electrical outlet controlled by a wall switch or dimmer because the defibrillator/monitor may be accidentally turned off. If the integrity of the ac power source is in doubt, the defibrillator/monitor must be operated from its internal battery. Ac powe...

  • Page 33

    31 dc power the external dc power source can be used, when the defibrillator/monitor is used for the emergency condition in the moving car. Figure 8. Dc power connection 1. Connect an external dc-dc adaptor (input: 12-16 vdc output: 18vdc) to defibrillator/monitor rear panel connecter identified wit...

  • Page 34

    32 ecg cables and leads 1. Connect an ecg cable to the ecg connector making sure that the connector arrow is pointing panel (see figure 1) defibrillator paddle and pads 1. Connect a paddle or pads to paddle / pads connector on the defib rillator/monitor’s front panel. (see figure 1) 2. Use lead butt...

  • Page 35: Battery Operation

    33 battery operation do not disassemble, puncture, crush, heat above 100°c (212°f), or incinerate the battery. Be careful not to short the battery terminals because this could result in a fire hazard. Mediana has no information regarding the performance or effectiveness of its mediana defibrillator/...

  • Page 36

    34 operating the defibrillator/monitor on battery power the defibrillator/monitor has the rechargeable battery that can be used to power the defibrillator/monitor when ac power source or external dc-dc adaptor is not available. The battery status icon appears on the screen when the defibrillator/mon...

  • Page 37

    35 battery status indication when operating on batteries, the battery status icon in the lower part of the display indicates the battery charge condition. See table 9. Table 9. The defibrillator/monitor battery status icon battery status icons battery status icon color green (normal condition) yello...

  • Page 38

    36 this page is intentionally left blank..

  • Page 39

    37 using the defibrillator/monitor each time the defibrillator/monitor is used, check alarm limits to make sure that they are appropriate for the patient being monitored. If different alarm presets are used for the same or similar equipment in any single area, e.G. An intensive care unit or cardiac ...

  • Page 40

    38 only use thumbs to depress the paddle shock button. Failure to do so could result in the inadvertent depression of the energy select buttons, causing the defibrillator/monitor to disarm itself. Do not discharge the defibrillator/monitor except as indicated in the instructions. Do not permit gel t...

  • Page 41

    39 setting date and time you may set the date and time displayed on the screen and printed on the reports. 1. Rotate the multi function knob to highlight date/time , and then press the multi function knob to select date/time menu . Figure 11. Select date/time menu 2. Soft key menu will be changed to...

  • Page 42

    40 continued use this defibrillator/monitor retains the previous settings when the defibrillator/monitor is turned off for less than 10 seconds. And if the defibrillator/monitor was not turned off and less than 10 minutes have elapsed since the operation mode was last used, the defibrillator/monitor...

  • Page 43

    41 4-ch wave screen: ecg + spo 2 + abp + etco 2 figure 13. Normal screen (4 waveform, defibrillation mode, full option) large numeric screen figure 14. Large numeric screen (2 waveform, monitor mode, full option).

  • Page 44

    42 black-white invert screen (mono-color screen) figure 15. Black-white screen (4 waveform, defibrillation mode, full option).

  • Page 45: Alarms And Limits

    43 alarms and limits each time the defibrillator/monitor is used, check alarm limits to make sure that they are appropriate for the patient being monitored. If different alarm presets are used for the same or similar equipment in any single area, e.G. An intensive care unit or cardiac operating room...

  • Page 46

    44 figure 16. Volume menu display alarm priority and messages there are three possible priorities for visual and audible alarms: high, medium, and low. The high, medium, low priority messages and informative messages are displayed in the alarm/informative message area and the defibrillator messages ...

  • Page 47

    45 medium priority medium priority alarm indicates that prompt operator response is required. Table 12. Medium priority alarm parameter condition messages hr/pr high heart rate/pulse rate limits violated high heart rate/pulse rate limits violated low heart rate/pulse rate limits violated low heart r...

  • Page 48

    46 low priority low priority alarm indicates that operator awareness is required. Table 13. Low priority alarm parameter condition messages ecg ecg leads off ecg : leads off chest lead off ecg : chest lead off temp temperature probe disconnect temp1 : probe disconnect temp2 : probe disconnect temper...

  • Page 49

    47 informative messages informative messages indicate a system condition that needs to be corrected. Table 14. Informative messages condition messages ecg offset control ecg: signal calibration spo 2 pulse search spo 2 : pulse search spo 2 motion interference spo 2 : motion interference ibp no zero ...

  • Page 50

    48 condition messages analyzing ecg analyzing heart rhythm (voice prompt: analyzing heart rhythm. Do not touch the patient.) do not touch the patient do not touch the patient no shock advised no shock advised (voice prompt: non shock advised.) shock advised shock advised (voice prompt: shock advised...

  • Page 51

    49 visual alarm indication table 16. Visual alarm characteristics alarm category color flashing period duty cycle high priority red 700ms (about 1.43hz) 57% (on: 400ms / off: 300ms) medium priority yellow 2000ms (about 0.5hz) 60% (on: 1200ms / off: 800ms) low priority yellow - 100% (always on) when ...

  • Page 52

    50 changing alarm limits each time the defibrillator/monitor is used, check alarm limits to make sure that they are appropriate for the patient being monitored. If different alarm presets are used for the same or similar equipment in any single area, e.G. An intensive care unit or cardiac operating ...

  • Page 53

    51 alarm limits ranges table 18 describes the possible alarm limits. The defibrillator/monitor is shipped with factory default settings. Note: authorized personnel can define the way to save the power default. The detailed information is described in the service manual. Table 18. Alarm limits ranges...

  • Page 54

    52 parameters upper limit, default lower limit, default resolution (-6.0 ~ 40.0 kpa, 12.0 kpa) (-6.7 ~ 39.3 kpa, 3.7 kpa) (0.6 or 0.7 kpa) p2 diastolic (mmhg, kpa) adult/pediatric -45 ~ 300 mmhg, 70 mmhg (-6.0 ~ 40.0 kpa, 9.3 kpa) -50 ~ 295 mmhg, 40 mmhg (-6.7 ~ 39.3 kpa, 5.3 kpa 5 mmhg (0.6 or 0.7 ...

  • Page 55

    53 to off an audio: 1. To initiate an audible alarm off, press the alarm button and hold it for at least 2 seconds. 2. To cancel an audible alarm off condition, press the alarm button for 2 seconds again. This action disables audible alarms for a user-defined audio off period (3 min, 5 min, 10 min o...

  • Page 56

    54 this page is intentionally left blank..

  • Page 57: Ecg Monitoring

    55 ecg monitoring for best product performance and measurement accuracy, use only accessories supplied or recommended by mediana. Use accessories according to the manufacturer’s directions for use and your facility’s standards. It may cause burns to the patients or defibrillator/monitor failure to u...

  • Page 58

    56 general the process of depolarization and repolarization of the myocardium generates electric potentials that are sensed by ecg electrodes on the skin surface. These electrodes are typically attac hed to the patient’s right arm, left arm, and left leg. The defibrillator/monitor processes and ampl...

  • Page 59

    57 figure 19. 5 electrode placement note: one of 5-1 to 5-6 lead electrode placement sites for the fifth lead. 2. Connect the ecg lead. 3. Connect the ecg lead to the ecg connector on the defibrillator/monitor ’s front panel. 4. Attach the leads to the electrodes, and then apply the electrodes to th...

  • Page 60

    58 12-lead ecg using previously unpackaged electrodes or electrodes past the use by date may impair ecg signal quality. Remove electrodes from a sealed package immediately before use and follow the procedure for applying the electrodes. Computerized ecg interpretive statements should not be used wit...

  • Page 61

    59 qrs typing thereafter, the various qrs complexes are typed according to their morphology. An iterative process is used. Effectively, the first complex in lead i is compared with the second using first differences of each cycle. The comparison takes the form of moving one beat over the other and w...

  • Page 62

    60 wave measurement from the 12 average beats, a single combined function is formed and a provisional overall qrs onset and termination is determined by thresholding techniques. The provisional onset and termination are then used as starting points for a search for qrs onset and termination within e...

  • Page 63

    61 qrs components within the qrs complex, the amplitude and duration of the various q, r, s, r ’ waves are then measured. In keeping with the cse recommendations, the minimum wave acceptable has to have a duration >8 ms and an amplitude >20 v. With respect to global qrs duration, the glasgow program...

  • Page 64

    62 interval measurement with respect to intervals, the global qt interval is measured from the global qrs onset to the global t end. On the other hand, because the p onset is taken as being simultaneous in all 12 leads, the global pr interval measurement is from the p onset to the global qrs onset. ...

  • Page 65

    63 calculation feature figure 25. Measurement reference figure 25 shows the parameters obtained in ecg waveform to analyze the ecg. Overall p onset, p offset, qrs onset, qrs offset and t termination are determined from all 12 leads. Individual lead wave amplitudes are then obtained. P+, p- , q, r, s...

  • Page 66

    64 hypertrophy - left ventricular hypertrophy - right ventricular hypertrophy - biventricular hypertrophy results on st and t wave analysis results on st and t wave analysis shows diagnosis results of st and t waveform and measurement values. Myocardial infarction - inferior infarction - lateral inf...

  • Page 67

    65 measurement meaning stamp st wave amplitude in microvolts. 1/8stt amplitude in microvolts at a point which is 1/8 of the st-t interval. 2/8stt amplitude in microvolts at a point which is 2/8 of the st-t interval. 3/8stt amplitude in microvolts at a point which is 3/8 of the st-t interval. T+amp t...

  • Page 68

    66 description of hr/pr menu functions the calculated heart rate/pulse rate may be derived from different sources (ecg, spo 2 , nibp or ibp) as shown by the icon in the hr/pr numerical area. 1 hr/pr icon 5 hr/pr unit 2 hr/pr source icon 6 hr/pr value 3 pacer pulse detection icon 7 bell icon 4 ecg si...

  • Page 69

    67 hr/pr source you may select auto, hr, pr to decide the source of the heart rate or pulse rate. The hr/pr tone volume can be adjusted in the setup menu . Auto if you select auto, the defibrillator/monitor automatically derives the heart rate or pulse rate from one of the monitoring parameters in t...

  • Page 70

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  • Page 71

    69 aed(automated external defibrillator) mode the defibrillator/monitor will only administer a shock if it is needed. A voice prompt will tell you when to press the shock button to administer defibrillation therapy. The defibrillator/monitor should not be used on someone who is responsive when shake...

  • Page 72

    70 general defibrillation therapy is the definitive method for termination of a variety of potentially fatal arrhythmias. The defibrillator/monitor ’s automated external defibrillation (aed) mode is designed to guide you through standard treatment algorithms for cardiac arrest. The defibrillator/mon...

  • Page 73

    71 preparing for defibrillation the aed algorithm is not designed to handle erratic spiking problems caused by a properly or improperly functioning pacemaker. In patients with cardiac pacemakers, the defibrillator/monitor may have reduced sensitivity and not detect all shockable rhythms. 1. Confirm ...

  • Page 74

    72 2010 aha guidelines for cpr and ecc the 2010 aha guidelines for cpr and ecc are based on the most current and comprehensive review of resuscitation literature ever published, the 2010 ilcor international consensus on cpr and ecc science with treatment recommendations. Bystanders, first responders...

  • Page 75

    73 cpr guidelines 2010 perform the cpr call for help, get aed person not responsive? No signs of life? Address person and shake on shoulder! Engage other people to help you and alternate cpr! Look, listen and feel open the airway. Check for breathing! Note: “look, listen and feel” is removed from th...

  • Page 76

    74 using aed mode 1. Turn on the aed mode of defibrillator/monitor by rotating the mode select knob . 2. Verify the aed mode of defibrillator/monitor is activated normally and follow audio guidance and step icon. Note: it will take about 4 seconds to initialize aed mode. Step 1 check for response. A...

  • Page 77

    75 step 6 press the shock button now. Shock delivered. Step 7 it is safe to touch the patient. Begin cpr [beep] or if needed, begin cpr [beep] give two breaths. Stop cpr. Note: if you hear following voice while the aed mode of defibrillator/monitor is analyzing you should perform the following actio...

  • Page 78

    76 aha 2010 configuration it is safe to touch the patient. Begin cpr. Use the metronome sound from the defibrillator/monitor in aed mode for compression rate – the defibrillator/monitor emits a tone corresponding at least more than 100 beats per minute (to current aha guidelines). The defibrillator/...

  • Page 79

    77 table 24. Aed mode menu level1 menu level 2 menu or response level 3 menu or response level 4 menu or response patient info id confirm name confirm age confirm gender male female event records data review print id# id name age gender real-time data print download return patient info id, name, age...

  • Page 80

    78 this page is intentionally left blank..

  • Page 81: Manual Mode

    79 manual mode make sure that the ecg signal quality is good and that sync marks are correctly displayed above each qrs complex prior to performing synchronized defibrillation (cardioversion). Artifact introduced by paddle movement may resemble an r-wave and trigger a defibrillation shock when perfo...

  • Page 82

    80 preparing for defibrillation using adult paddles 1. External paddles are placed on the device. 2. Remove the paddles from the paddle tray by pulling the paddles straight up and out of the paddle tray. 3. Apply conductive matter to the paddle electrodes. Do not distribute conductive matter by rubb...

  • Page 83

    81 defibrillating (async mode) if the device and paddles are prepared for defibrillation, perform the following steps; 1. To select the energy setting, press the select energy level button and rotate the multi function knob to the desired energy level. Energy choices range from 1 to 200j. (to choose...

  • Page 84

    82 4. To charge the energy, press the charge button . If using external paddles, the charge button on the paddles may be used instead. Note: you may increase or decrease the selected energy at any time during charging or after charging is complete. 5. There are two ways to shock the energy. 5.1 pres...

  • Page 85

    83 description of manual mode menu functions figure 33. Manual mode menu table 25. Manual mode menu level1 menu level 2 menu or response level 3 menu or response level 4 menu or response 12 lead acquire setup filter 0.05hz ~ 40hz 0.05hz ~ 150hz transmission 12 lead on patient info id confirm name co...

  • Page 86

    84 level1 menu level 2 menu or response level 3 menu or response level 4 menu or response 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 erase data erase 12 lead records yes no erase event records yes ...

  • Page 87

    85 level1 menu level 2 menu or response level 3 menu or response level 4 menu or response id confirm name confirm age confirm gender male female event records data review print id# id name age gender real-time data print download return sync on/off 12 lead acquire to acquire the 12 lead ecg data fro...

  • Page 88

    86 1. Rotate the multi function knob to highlight alarm volume, beep volume or button volume. 2. Press the multi function knob . Levels of alarm volume, beep volume or button volume will appear. 3. Rotate the multi function knob to select a volume level. 4. Press the multi function knob to enter a d...

  • Page 89

    87 alarm limit figure 35. Alarm limit menu press the multi function knob to select alarm limits. The defibrillator/monitor will display all alarm limits that are currently in effect for all monitored parameters. Select the alarm limits to set patient info id, name, age or gender of patients can be e...

  • Page 90

    88 this page is intentionally left blank..

  • Page 91: Monitor Mode

    89 monitor mode general in monitor mode, you can monitor electrocardiography (ecg) acquired a 3-. 5-, or 10- lead ecg electrodes. Optional monitoring of functional arterial oxygen saturation (spo 2 ), respiration (resp), temperature (temp), invasive blood pressure (ibp), noninvasive blood pressure (...

  • Page 92

    90 level1 menu level 2 menu or response level 3 menu or response level 4 menu or response id # id name age gender setup volume alarm beep button charging alarm voice prompt cpr metronome pacing alarm printer setting print on alarm on off print on charge on off print on shock on off print on mark on ...

  • Page 93

    91 level1 menu level 2 menu or response level 3 menu or response level 4 menu or response ibp1 ibp2 etco 2 display mode large numeric display black-white invert mode clinical action list manual self- test button test service menu (display 3 digit code) return alarm limit ▲ upper alarm limit ▼ lower ...

  • Page 94

    92 setup figure 38. Setup menu volume the volume options allow you to adjust the volume of alarm, beep, button, charging alarm, voice prompt, cpr metronome, pacing alarm. Alarm volume, charging alarm and voice prompt can be set at level 1 to 8 and beep volume, button volume, cpr metronome and pacing...

  • Page 95

    93 button test the u ser can check buttons for proper functioning. It can be performed by ‘button test’ function in the setup menu . Service menu only authorized personnel are allowed to change the service menu settings. A 3 digit code is required for access. Refer to the service manual for instruct...

  • Page 96

    94 this page is intentionally left blank..

  • Page 97: Pacing Mode

    95 pacing mode use sync mode pacing whenever possible. Use fixed mode pacing when motion artifact or other ecg noise makes r-wave detection unreliable. Observe the patient continuously while the pacemaker is in use. Patient response to pacing therapy (for example, capture threshold) may change over ...

  • Page 98

    96 demand mode and fixed mode the defibrillator/monitor can deliver pace pulses in either demand mode or fixed mode. 1. In demand mode, the defibrillator/monitor only delivers pace pulses when the patient’s heart rate is lower than the selected pacing rate. 2. In fixed mode, the defibrillator/monito...

  • Page 99

    97 4. When the ma button is pressed, each color of output value is changed and the output value can be modified. 5. The ‘select ma’ defibrillator message is displayed. 6. Rotate the multi function knob to the desired output value and then press the multi function knob to select the desired output va...

  • Page 100

    98 description of pacing mode menu functions figure 42. Pacing mode menu table 27. Pacing mode menu level1 menu level 2 menu or response level 3 menu or response level 4 menu or response pause pacing setup volume alarm beep button charging alarm voice prompt cpr metronome pacing alarm printer settin...

  • Page 101

    99 level1 menu level 2 menu or response level 3 menu or response level 4 menu or response no erase internal memory yes no erase internal memory yes no waveform setting 2 nd waveform ecg waveform i, ii, iii, avl, avf, avr, v1, v2, v3, v4, v5, v6, pads spo 2 waveform respiration waveform ibp1 waveform...

  • Page 102

    100 pause pacing when the pause pacing soft key is pressed, if pacing is operating, pacing will be paused, if pacing is not operating, pacing will be resumed. Setup figure 43. Setup menu volume the volume options allow you to adjust the volume of alarm, beep, button, charging alarm, voice prompt, cp...

  • Page 103

    101 section. Button test the user can check buttons for proper functioning. It can be perform ed by ‘button test’ function in the setup menu . Service menu only authorized personnel are allowed to change the service menu settings. A 3digit code is required for access. Refer to the service manual for...

  • Page 104

    102 this page is intentionally left blank..

  • Page 105: Nibp Monitoring

    103 nibp monitoring for best product performance and measurement accuracy, use only accessories supplied or recommended by mediana. Use accessories according to the manufacturer’s directions for use and your facility’s standards. Inaccurate measurements may be caused by incorrect cuff application or...

  • Page 106

    104 fibrillation, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases, patient motion, trembling, and shivering. In the automatic mode, the defibrillator/monitor displays results of the last blood pressure measurement until another measurement starts. If a pat...

  • Page 107

    105 to increase in amplitude with decreasing cuff pressure until they reach a maximum amplitude at which point they begin to decrease with decreasing cuff pressure. The cuff pressure at which the pulse amplitude is the greatest is known as mean arterial pressure (map). The manner in which the pulse ...

  • Page 108

    106 b. For data collection and the data analysis, bland-altman plot is used. C. On the systolic, diastolic, and map, the deltas of all measurements shall be met under +/- 5mmhg of mean difference (md), and +/- 8mmhg of standard deviation (sd). (delta = intra-arterial or auscultatory – automated sphy...

  • Page 109

    107 defibrillator/monitor but, as described above, determines blood pressure from an uninterrupted changing curve, which means that the oscillometric method is not easily effected by external noise and electrosurgical instruments. Note: this equipment is suitable for use in the presence of electro-s...

  • Page 110

    108 table 28. Cuff size model number arm circumference (cm) neonate cuff no.10 3.5 to 6 cuff no.11 5.0 to 7.5 cuff no.12 7.5 to 10.5 cuff no.13 8.5 to 13 pediatric hem-cs23 13 to 22 hxa-gcuff-ssla 12 to 18 hxa-gcuff-sla 17 to 22 adult hem-cr23 22 to 32 hem-cl23 32 to 42 hem-cx23 42 to 50 hxa-gcuff-m...

  • Page 111

    109 ▼ map lower limit adjust ▲ dia upper limit adjust ▼ dia lower limit adjust (limit alarm pause) on, off return note: initial inflate pressures shown above are for adult patient mode. In order to set alarm limits to neonatal mode, change patient type via the setup menu . Note: the nibp unit can on...

  • Page 112

    110 this page is intentionally left blank..

  • Page 113: Spo

    111 spo 2 monitoring for best product performance and measurement accuracy, use only accessories manufactured by nellcor ® or supplied by mediana. Use access ories according to the manufacturer’s directions for use and your facility’s standards. Tissue damage can be caused by incorrect application o...

  • Page 114

    112 flow to the extremities (such as those in severe shock or hypothermia), or in the presence of excessive motion. Failure to apply the sensor properly may reduce the accuracy of the spo 2 measurement. Inspection the sensor application site at least every two hours for changes in skin quality, corr...

  • Page 115

    113 theory of operation the defibrillator/monitor uses pulse oximetry to measure functional oxygen saturation in the blood. Pulse oximetry works by applying a nellcor ™ pulse oximetry sensor to a pulsating arteriolar vascular bed, such as a finger or toe. The sensor contains a dual light source and ...

  • Page 116

    114 figure 48. Oxyhemoglobin dissociation curve 1 % saturation axis 6 increased ph; decreased temperature, pco 2 , and 2,3-dpg 2 po 2 (mmhg) axis 7 decreased ph; increased temperature, pco 2 , and 2,3-dpg.

  • Page 117

    115 clinical studies clinical studied conducted for the nellcor™ sensors overview this appendix contains data from clinical studies conducted for the nellcor™ sensors used with the defibrillator/monitor. One (1) prospective, controlled hypoxia clinical study was conducted to demonstrate the accuracy...

  • Page 118

    116 figure 49. Modified bland-altman plot 1 test sensor: avg co-oximeter value 70-100% spo 2 2 avg co-oximeter value 70-100% spo 2 oximetry board with max-a sensor trendline of max-a sensor oximetry board with max-n sensor trendline of max-n sensor oximetry board with max-fast sensor trendline of ma...

  • Page 119

    117 setup connections when selecting a sensor, consider the patient’s weight and activity, adequacy of perfusion, availability of sensor sites, need for sterility, and anticipated duration of monitoring. Refer to table 32, or contact nellcor ® or mediana sales department for ordering information. 1....

  • Page 120

    118 description of spo 2 menu functions 1 spo 2 icon 3 spo 2 value 2 pulse amplitude indicator 4 bell icon figure 50. Spo 2 display 1 spo 2 waveform icon 2 spo 2 waveform figure 51. Spo 2 waveform display pulse amplitude indicator the pulse amplitude indicator is the segmented display within the spo...

  • Page 121: Respiration Monitoring

    119 respiration monitoring for best product performance and measurement accuracy, use only accessories supplied or recommended by mediana. Use accessories according to the manufacturer’s directions for use and your facility’s standards. The defibrillator/monitor does not detect apnea when the respir...

  • Page 122

    120 theory of operation 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 material...

  • Page 123

    121 description of respiration menu functions 1 respiration rate icon 4 respiration icon 2 respiration rate source icon 5 measurement value 3 bell icon figure 53. Respiration display 1 respiration waveform icon 2 respiration waveform figure 54. Respiration waveform display respiration respiration se...

  • Page 124

    122 rr source user can select either airway or impedance for source of the respiration rate. If the auto is selected, the defibrillator/monitor will automatically drive the respiration rate from one of the monitoring parameters in this order of priority; airway and impedance. Note: you can select ai...

  • Page 125: Capnography Monitoring

    123 capnography monitoring for best product performance and measurement accuracy, use only accessories supplied or recommended by mediana. Use accessories according to your facility’s standards and the manufacturer’s recommendation. Always refer to the manufacturer’s directions for use for instructi...

  • Page 126

    124 when using the defibrillator/monitor in high-altitude environments, it is advisable to consider adjusting etco 2 alarm settings accordingly. Do not operate the capnostat sensor when it is wet. Do not immerse the device in water. Do not operate the capnostat sensor if it appears to have been dama...

  • Page 127

    125 setup connections the defibrillator/monitor has one capnography sensor receptacle which may be used for a mainstream capnography sensor or a sidestream capnography sensor. Note: capnograpy is not analyzed during unit warm-up however, the capnography does display to indicate that the defibrillato...

  • Page 128

    126 sidestream operation sidestream monitoring uses an external, sidestream sensor that plug into the capnography port on the defibrillator/monitor. Adult, pediatric, or infant sampling lines are then plugged into the sensor receptacle. Respiration can be monitored for intubated or non-intubated pat...

  • Page 129

    127 description of etco 2 menu functions 1 etco 2 icon 5 etco 2 unit 2 etco 2 value 6 bell icon 3 inco 2 icon 7 inco 2 unit 4 inco 2 value figure 58. Etco 2 display 1 etco 2 waveform icon 2 etco 2 waveform figure 59. Etco 2 waveform display figure 60. Etco 2 menu display table 35. Etco 2 menu menu l...

  • Page 130

    128 etco 2 when the capno measurement is on, etco 2 , inco 2 and capno waveform measurement are activated. Etco 2 setting o 2 gas as the n 2 in the sample gas is replaced by o 2 , the effect is a decrease in ir absorption. This results in a lower than actual measured co 2 value (co 2 measured). It i...

  • Page 131: Temperature Monitoring

    129 temperature monitoring for best product performance and measurement accuracy, use only ysi 400 and 700 series temperature probes recommended by mediana. Use accessories according to the manufacturer’s directions for use and your facility’s standards. General measurement of patient temperature is...

  • Page 132

    130 description of temperature menu functions 1 temperature1 icon 5 temperature1 unit 2 temperature1 value 6 bell icon 3 temperature2 icon 7 temperature2 unit 4 temperature2 value figure 61. Temperature display alarm limit return figure 62. Temperature menu display table 37. Temperature menu menu le...

  • Page 133: Ibp Monitoring

    131 ibp monitoring proper measurements may not be possible, if improper zero calibration was performed. If air bubbles are mixed into the patient circuit. If the height of the three-way tap for zero calibration and the right auricle have changed. If the pressure transducer has been dropped or subjec...

  • Page 134

    132 general the invasive blood pressure measurement measures the systolic pressure, mean pressure, diastolic pressure and pulse rate for up to 2 blood pressure line channels using blood pressure transducers, and displays the blood pressure waveform. Theory of operation the pressure transducer is con...

  • Page 135

    133 description of ibp 1 menu functions 1 ibp 1 label icon 4 ibp 1 unit 2 systolic value 5 diastolic value 3 mean arterial pressures value 6 bell icon figure 64. Ibp 1 display 1 ibp 1 label icon 2 ibp 1 waveform figure 65. Ibp 1 waveform display zero setting scale label alarm limit return figure 66....

  • Page 136

    134 zero setting when zero setting is set to enter, ibp 1 channel is calibrated. Scale the user-selectable pressure waveform scale allows you to adjust the scale of a pressure waveform. The scale can be selected as 0 to 0 ~ 50mmhg, 0 ~ 100mmhg, 0 ~ 200mmhg, 0 ~ 300mmhg or auto. Label the label can b...

  • Page 137

    135 table 39. Ibp 2 menu level 1 menu level 2 menu or response ibp 2 menu zero setting enter scale 0 ~ 50mmhg, 0 ~ 100mmhg, 0 ~ 200mmhg, 0 ~ 300mmhg, auto label p2 cvp pap lap (alarm limit) ▲ sys upper limit adjust ▼ sys lower limit adjust ▲ mean upper limit adjust ▼ mean lower limit adjust ▲ dia up...

  • Page 138

    136 this page is intentionally left blank..

  • Page 139: Self-Test Function

    137 self-test function general this defibrillator/monitor incorporates a self-test function. The defibrillator/monitor should be checked at regular intervals so that it will always be ready-to-use for emergency situations. There are three modes: manual self-test, auto self-test and button test. Addi...

  • Page 140

    138 functions to be tested in self-test the defibrillator/monitor self-test performs 11 test steps. Lists and descriptions of the tests are indicated below. Figure 70. Auto self-test display table 40. Self-test functions no. Test description 1 high-voltage module operational test to check if the hig...

  • Page 141

    139 external shock test the user must verify the ability to deliver defibrillation energy once a week. Figure 71. External shock test 1. Make sure the paddles and the paddle tray are thoroughly clean and there is no residue including the conductive material on electrode surfaces of the paddle and pa...

  • Page 142

    140 this page is intentionally left blank..

  • Page 143: Event

    141 event general event data in either graphical or tabular format may be displayed on 3 rd and 4 th waveform display area. 1. Press the patient info soft key. 2. Rotate the multi function knob to event records on the screen and press the multi function knob to display. The event data is stored in m...

  • Page 144

    142 event review display event information in graphical format for ecg data is displayed in a graph. The defibrillator/monitor displays the event information through recent 10sec after and before event occurred. When printing the event information, all the parameters like ecg, spo 2 , nibp, temp, et...

  • Page 145

    143 12 lead record display the 12 lead data is displayed in tabular format as shown in figure 74. Patient id, name, age, gender and time are displayed. The newest data appears at the top of tabular events. To scroll the event data list, rotate the multi function knob when the 12 lead data list is di...

  • Page 146

    144 this page is intentionally left blank..

  • Page 147: Real-Time Data

    145 real-time data general this defibrillator/monitor is designed to print the real-time data and download to real- time data in sd card. Real-time data menu list of real-time data shows a maximum of 18 data in real-time data menu as shown in figure 75. When the real-time data has been exceeded 18 d...

  • Page 148

    146 real-time data recording real-time data contains header(print case, patient info and device info), event messages, waveform, shock information and trend in real time. In order to write by user, the comments, weight, height, device type and operator are left blank. Header recording the defibrilla...

  • Page 149

    147 waveform recording waveform which the event occurred is displayed. Waveform contains ecg, v-fib, shock and pacing event as shown in figure 77. Shock information recording shock info displays the shock event among all events. Shock info contains shock time, number of shock and energy as shown in ...

  • Page 150

    148 this page is intentionally left blank..

  • Page 151: Menu Structure

    149 menu structure manual mode menu - 12 lead - - acquire - - setup - - - filter - - - - 0.05hz ~ 40hz - - - - 0.05hz ~ 150hz - - - - return - - - transmission - - - return - - 12 lead on - - - on - - - off - - patient info - - - id - - - - confirm - - - - return - - - name - - - - confirm - - - - r...

  • Page 152

    150 - - - - 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 - - - return - - erase data - - - erase 12 lead re...

  • Page 153

    151 - - - - - v1 - - - - - v2 - - - - - v3 - - - - - v4 - - - - - v5 - - - - - v6 - - - - - pads - - - - spo 2 - - - - resp - - - - ibp1 - - - - ibp2 - - - - etco 2 - - - 4 th waveform - - - - ecg - - - - - l - - - - - ll - - - - - lll - - - - - avl - - - - - avf - - - - - avr - - - - - v1 - - - - -...

  • Page 154

    152 - - on on on on on on on on on - - off off off off off off off off off - - return - patient info - - id - - - confirm - - - return - - name - - - confirm - - - return - - age - - - confirm - - - return - - gender - - - male - - - female - - event records - - - data review - - - - print - - - - r...

  • Page 155

    153 - - - - id - - - - name - - - - age - - - - gender - - - - return - - - return - - real-time data - - - - print - - - - download - - - - return - - - return - resume analyzing (menu activated only during cpr mode) pacing mode menu - pause/resume pacing - setup - - volume - - - alarm - - - beep -...

  • Page 156

    154 - - - - yes - - - - no - - - erase internal memory - - - - yes - - - - no - - - return - - waveform setting - - - 2 nd waveform - - - - ecg - - - - - l - - - - - ll - - - - - lll - - - - - avl - - - - - avf - - - - - avr - - - - - v1 - - - - - v2 - - - - - v3 - - - - - v4 - - - - - v5 - - - - - ...

  • Page 157

    155 - - - - - v3 - - - - - v4 - - - - - v5 - - - - - v6 - - - - - pads - - - - spo 2 - - - - resp - - - - ibp1 - - - - ibp2 - - - - etco 2 - - - return - - clinical action list - - display mode - - - large numeric display - - - black-white invert mode - - - return - - manual self-test - - button tes...

  • Page 158

    156 - - - - return - - - id# - - - - id - - - - name - - - - age - - - - gender - - - - confirm - - - - return - - - return - - real-time data - - - - print - - - - download - - - - return - - - return - demand / fixed monitor mode menu - 12 lead - - acquire - - setup - - - filter - - - - 0.05hz ~ 4...

  • Page 159

    157 - - - cpr metronome - - - pacing alarm - - - return - - printer setting - - - 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 - - - p...

  • Page 160

    158 - - - - resp - - - - ibp1 - - - - ibp2 - - - - etco 2 - - - 3 rd waveform - - - - ecg - - - - - l - - - - - ll - - - - - lll - - - - - avl - - - - - avf - - - - - avr - - - - - v1 - - - - - v2 - - - - - v3 - - - - - v4 - - - - - v5 - - - - - v6 - - - - - pads - - - - spo 2 - - - - resp - - - - i...

  • Page 161

    159 hr/pr spo 2 resp etco 2 inco 2 t1 t2 120 100 30 80 20 39.0 39.0 50 90 8 0 0 36.0 36.0 - - on on on on on on on - - off off off off off off off nibp p1 cvp sys map dia sys mean dia sys mean dia 160 110 90 120 90 70 120 90 70 90 60 50 70 50 40 70 50 40 - - on on on on on on on on on - - off off of...

  • Page 162

    160 monitoring parameter (it is applied to 4 modes equally) hr/pr menu - hr/pr source - - auto - - hr - - pr - - return - pacer detect - - enable - - disable - - return - filter select - - 0.5hz ~ 21hz - - 0.05hz ~ 40hz - - 1hz ~ 21hz - - return - alarm limit “alarm limit” - hr/pr 120 50 “limit alar...

  • Page 163

    161 - - 260 mmhg - - 280 mmhg - - return - - “neonatal” - - 80 mmhg - - 100 mmhg - - 120 mmhg - - 140 mmhg - - return - auto interval - - off - - cont - - 1 min - - 2.5 min - - 3 min - - 5 min - - 10 min - - 15 min - - 20 min - - 30 min - - 60 min - - 90 min - - return - patient type - - adult / ped...

  • Page 164

    162 ibp1 menu - zero setting - - enter - - return - scale - - 0~50mmhg - - 0~100mmhg - - 0~200mmhg - - 0~300mmhg - - auto - - return - label - - p1 - - abp - - return - alarm limit “alarm limit (mmhg)” - sys mean dia 120 90 70 70 50 40 “limit alarm pause” - on - off - return ibp2 menu - zero setting...

  • Page 165

    163 etco 2 menu - etco 2 - - on - - off - - return - etco 2 setting - - n 2 o gas - - - on - - - off - - - return - - o 2 gas - - - on - - - off - - - return - - calibration - - - enter - - - return - scale - - 0~40mmhg - - 0~60mmhg - - 0~80mmhg - - auto - - return - alarm limit “alarm limit” - etco...

  • Page 166

    164 - - 40 seconds - - 50 seconds - - 60 seconds - - return - alarm limit “alarm limit” - resp 30 8 “limit alarm pause” - on - off - return temperature menu - alarm limit “alarm limit (ºc)” t1 t2 39.0 39.0 36.0 36.0 “limit alarm pause” - on on - off off - return date time menu - date format - - yy/m...

  • Page 167: Printing

    165 printing general the defibrillator/monitor prints real-time graphical and numeric information after that event in accordance with current mode until print soft key is pressed. Printing may be set in two ways: 1. When the print is displayed on the screen, select the print soft key . 2. To start p...

  • Page 168

    166 print on mark if print on alarm is set to on, the defibrillator/monitor will automatically print out information before and after 10 seconds when a clinical action is activated. Print on bp if print on alarm is set to on, the defibrillator/monitor will automatically print out information before ...

  • Page 169

    167 print-out on 12 lead ecg data if 12 lead auto printing is set to on, the defibrillator/monitor prints the 12 lead ecg data automatically after 12 lead ecg analysis. When the defibrillator/monitor displays 12 lead records, desired 12 lead ecg analysis can be printed by pressing print soft key . N...

  • Page 170

    168 2010-01-01 05:30:00 system setting------------------------------------- system information serial number : 000000000000 main software : 0.00.00 display software : 0.00.00 (eng) analog software : 0.00.00 voice prompt : 0.0 (eng) charger : 0.00 printer : 0.00 h/v : 0.00 ecg : 0.00 spo2 : 0.0.0.0 n...

  • Page 171: External Interface

    169 external interface general the defibrillator/monitor provides external connectors on the right panel to support communication with external equipment and functions such as software upgrade or data download. The defibrillator/monitor with its optional wireless network(3g or wi-fi) module, functio...

  • Page 172

    170 central system communication the transmitted data by using 3g/wi-fi module is divided as follows; - all vital signs are transmitted to the medical person in the hospital. - 12-lead reports for 20 seconds are transmitted to the medical person in the hospital. - the self-test result and the log fi...

  • Page 173: Maintenance

    171 maintenance the cover should be removed only by qualified service personnel. There are no internal user-serviceable parts except for the battery. Do not use the defibrillator/monitor when the case appears damaged. Do not spray, pour, or spill any liquid on the defibrillator/monitor, its accessor...

  • Page 174

    172 returning the defibrillator/monitor and system components pack the defibrillator/monitor with sensors, cable or other accessory items in its original shipping carton. If the original carton is not available, use a suitable carton with appropriate packing material to protect the defibrillator/mon...

  • Page 175

    173 battery maintenance recharging the battery is strongly recommended when the battery has not been recharged for 6 or more months. Follow local government ordinances and recycling instructions regarding disposal or recycling of defibrillator/monitor components, including batteries. Do not short-ci...

  • Page 176

    174 loading printer paper using other manufacturers’ printer paper may cause the printer to function improperly or damage the print head. Use only mediana printer paper. Load printer paper as follows: 1. Pull the printer door. 2. Pick out the paper by using the ejector. 3. Insert a new printer paper...

  • Page 177: Troubleshooting

    175 troubleshooting if you are uncertain about the accuracy of any measurement, check the patient’s vital signs by alternate means; then make sure the defibrillator/monitor is functioning correctly. The cover should be removed only by qualified service personnel. There are no user-serviceable parts ...

  • Page 178

    176 emi (electromagnetic interference) keep patients under close surveillance when monitoring. It is possible, although unlikely, that radiated electromagnetic signals from sources external to the patient and defibrillator/monitor can cause inaccurate measurement readings. Do not rely entirely on th...

  • Page 179

    177 the defibrillator/monitor is designed for use in environments in which the signal can be obscured by electromagnetic interference. During such interference, measurements may seem inappropriate or the defibrillator/monitor may not seem to operate correctly. The defibrillator/monitor disruption ma...

  • Page 180

    178 this page is intentionally left blank..

  • Page 181: Factory Defaults

    179 factory defaults general the defibrillator/monitor is shipped with factory default settings. Authorized personnel can use the procedures described in the service manual to change default settings. Parameter ranges and default settings table 43. Parameter ranges and factory defaults parameter ran...

  • Page 182

    180 parameter ranges / selections (adjust step) factory defaults 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) 90 mmhg (12.0 kpa) neonatal 40 mmhg (5.3 kpa) nibp dia high alarm limits adult/pediatric 15 to 250 mmhg (2.0 to 33.3 kpa) neonatal...

  • Page 183

    181 parameter ranges / selections (adjust step) factory defaults -45 to 300 mmhg (-6.0 to 40.0 kpa) (5 mmhg, 0.6 or 0.7kpa steps) 90 mmhg (12.0 kpa) ibp 1 mean low alarm limits adult/pediatric -50 to 295 mmhg (-6.7 to 39.3 kpa) (5 mmhg, 0.6 or 0.7kpa steps) adult/pediatric 50 mmhg (6.7 kpa) ibp2 men...

  • Page 184

    182 parameter ranges / selections (adjust step) factory defaults 0 to 19 mmhg (0 to 2.5 kpa), (0 to 2.5 %) (1 mmhg, 0.13 kpa steps) 0 mmhg (0 kpa), (0 %) etco 2 unit* mmhg, kpa, % mmhg temperature menu temp1 high alarm limits 0.1 to 50.0 °c (32.2 to 122.0 °f) (0.1°c, 0.1 or 0.2°f steps) 39.0 °c (102...

  • Page 185

    183 parameter ranges / selections (adjust step) factory defaults message display* on, off off elapsed time display* enable, disable enable cpr guide display* enable, disable enable voice prompt* enable, disable enable basic auto energy escalation* enable, disable enable above 200j setting* enable, d...

  • Page 186

    184 parameter ranges / selections (adjust step) factory defaults 0096fa, fa00fa, 96fa32, c8c8c8, 0096c8, c89600, c8c832 parameters color - spo 2 * 00fa00(green), fafafa(white), 64fafa(cyan), 6464fa(light blue), fa96fa(pink), fa0000(red), fafa00(yellow), 9696c8(light purple), fa9600, 0096fa, fa00fa, ...

  • Page 187

    185 parameter ranges / selections (adjust step) factory defaults pacing mode protection* disable, confirm, passcode disable pacing mode locking passcode* 000~999 (passcode) service menu passcode* 000~999 (passcode) power on waveform select – 1st waveform* ecg i, ecg ii, ecg iii, pads ecg i power on ...

  • Page 188

    186 this page is intentionally left blank..

  • Page 189: Specification

    187 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 190

    188 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 191

    189 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 192

    190 tone definition high priority alarm tone volume level adjustable (level 1~8) pitch (± 48.8hz) 976 hz pulse width (± 10msec) 210 msec 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) 6...

  • Page 193

    191 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 194

    192 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 195

    193 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 196

    194 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 197

    195 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 198

    196 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 199

    197 temperature thermistor temp probe type thermistor probe ysi 400 series and 700 series measurement method thermistor operating mode direct range 0.0 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...

  • Page 200

    198 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 201

    199 manual mode manual mode charging time – 200j charging condition time (sec) with rated mains voltage 5.8 with dc mains voltage 5.9 with ful y 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 202

    200 number of discharges the number of maximum energy discharges which are available from a new and fully charged battery at 20°c 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-shoc...

  • Page 203

    201 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 desc...

  • Page 204

    202 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 vertic...

  • Page 205

    203 figure 88. Biphasic waveforms at 175 joules figure 89. Biphasic waveforms at 150 joules.

  • Page 206

    204 figure 90. Biphasic waveforms at 125 joules figure 91. Biphasic waveforms at 100 joules.

  • Page 207

    205 figure 92. Biphasic waveforms at 75 joules figure 93. Biphasic waveforms at 50 joules.

  • Page 208

    206 figure 94: biphasic waveforms at 40 joules figure 95. Biphasic waveforms at 30 joules.

  • Page 209

    207 figure 96. Biphasic waveforms at 20 joules figure 97. Biphasic waveforms at 10 joules.

  • Page 210

    208 figure 98. Biphasic waveforms at 9 joules figure 99. Biphasic waveforms at 8 joules.

  • Page 211

    209 figure 100. Biphasic waveforms at 7 joules figure 101. Biphasic waveforms at 6 joules.

  • Page 212

    210 figure 102. Biphasic waveforms at 5 joules figure 103. Biphasic waveforms at 4 joules.

  • Page 213

    211 figure 104. Biphasic waveforms at 3 joules figure 105. Biphasic waveforms at 2 joules.

  • Page 214

    212 figure 106. Biphasic waveforms at 1 joules.

  • Page 215

    213 compliance item standard description classification iec 60601-1:2005 +a1:2012, en 60601-1:2006 +a1:2013 class i (on ac power) internally powered (on battery power) type of protection iec 60601-1:2005 +a1:2012, en 60601-1:2006 +a1:2013 type bf and type cf – applied part mode of operation iec 6060...

  • Page 216

    214 item standard description /ac:2010 iso10993-5:2009, en iso10993-5:2009 biological evaluation of medical devices – part 5: tests for in vitro cytotoxicity iso10993-10:2010, en iso10993-10:2010 biological evaluation of medical devices – part 10: tests for irritation and delayed-type hypersensitivi...

  • Page 217

    215 item standard description temperature monitoring iso 80601-2-56:2009, en iso 80601-2-56:2012 performance of electrical thermometers for continuous measurement invasive blood pressure iec 60601-2-34:2011 en 60601-2-34:2014 particular requirements for the safety, including essential performance, o...

  • Page 218

    216 item standard description en60068-2-1:2007 cold iec60068-2-2:2007 en60068-2-2:2007 environmental testing - part 2-2: tests - test b: dry heat iec60068-2-30:2005 en60068-2-30:2005 environmental testing - part 2-30: tests - test db: damp heat, cyclic (12 h + 12 h cycle) reliability iec60068-2-27:2...

  • Page 219

    217 manufacturer’s emc declaration for best product performance and measurement accuracy, use only accessories supplied or recommended by mediana. Use accessories according to the manufacturer’s directions for use and your facility’s standards. The use of accessories, transducers, and cables other t...

  • Page 220

    218 immunity test iec 60601-1-2 test level compliance level electromagnetic environment guidance frequency (50/ 60 hz) magnetic field iec 61000-4-8 the defibrillator/monitor further from the sources of power frequency magnetic fields or to install magnetic shielding. The power frequency magnetic fie...

  • Page 221

    219 immunity test iec 60601 test level compliance level electromagnetic environment guidance a field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, am and fm radio broadcast, and tv broadcast cannot be predicted theoretically ...

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    220 table 50. Cables (iec60601-1-2) cables and sensors maximum length complies with ac power cable 2.5m -rf emissions, cispr 11, class b/ group 1 -harmonic emissions, iec 61000-3-2 -voltage fluctuations/flicker emission, iec 61000-3-3 -electrostatic discharge (esd), iec 61000-4-2 -electric fast tran...