Mediana P10 Manuale di Servizio

SERVICE MANUAL Patient Monitor M30 EU representative TECNOMED 2000 S.L. Valencia, 25 - 28012 Madrid Spain Manufacturer Mediana Co.,

4 Note: The numeric after dash can be changed to 1, 3 or 5 in accordance with the operating time of the installed battery. The numeric “0” represents

94 Unit Description z Power unit: consists of SMPS and battery charger AC-DCAC 100-240V50/60HzChargerFUSELi-ion Battery 3S1P/2200mAh3S2P/4400mAh3S3

95 z User-control unit: consists of jog dial, 5 functional buttons, optical encoder, power on indicator LED, Battery charging indicator LED and batt

96 z GUI (graphic user interface) unit: consists of TFT LCD, inverter for backlight and internal LCD controller. 8.5" TFT LCDInverterFor backli

97 z ECG unit: measures electrocardiographic waveform data. Protection CircuirtPatientCableInput Buffer&FilterLead off detectorDriven circuitsat

98 z Temperature unit: measures temperature data. RC CircuitHigh Accuracy ResistorTemperature ProbeIsolation DC/DCDC +5VIsolation DC +11Vdc ±1

99 ECG Processing The measurement of the skin surfaces electrocardiogram is based on the electrical signals on the skin surface, produced as the hea

100 ● Oscillometric Response (Pressure Pulses) ● Cuff Pressure SystoleSystoleMAPDistoleMAPDistoleDistoleMAPSystoleTIMETIME Overall Accu

101 20-20-15-10-5051015200180160140120100SYSTOLIC PRESSUREMean difference(MD): 0 mmHgStandard deviation(SD): 6 mmHgmean + 2 SDmeanmean - 2 SDAverage

102 No Calibration Required (Mediana module) Pulse oximeter requires neither production, nor user calibration. The relationship between light absorpt

103 SpO2 Accuracy (Mediana module) The saturation (SpO2) accuracy specification was proven by comparisons with the arterial blood gas measurements. S

5 Front Panel Components 1 Alarm indicator 6 NIBP start/stop button 2 LCD 7 Print button 3 AC indicator 8 Home button 4 Battery chargi

104 Temperature Processing Measurement of patient temperature is accomplished by processing the signal from a probe containing a resistor whose resi

6 Rear Panel Components Figure 2. Rear Panel Components 1 Handle 2 AC power connector 3 Equipotential terminal 4 DC power connec

7 Left Panel Components 1 Printer (option) 2 USB port (mini USB B Type) 3 USB port (USB A Type) 4 RJ11 port Figure 3. Left Panel Components

8 Right Panel Components 1 ECG connector 2 SpO2 connector 3 NIBP connector 4 Temperature connector 5 CO2 connector (Option) Figure 4. Right Pa

9 ROUTINE MAINTENANCE WARNING: Do not spray or pour any liquid on the monitor or its accessories. Do not immerse the monitor or its accessories in

10 Batteries If the monitor has not been used for a long period of time, more than 6 months, the battery will need charging. To charge the battery,

11 PERFORMANCE VERIFICATION General This section discusses the tests used to verify performance following repairs or during routine maintenance. Al

12 Performance Tests The battery charge and battery discharge test should be performed before monitor repairs whenever the battery is suspected as b

13 displayed about 15 minutes before battery fully discharges. 11. Allow the monitor to operate until it automatically powers down due to the low bat

Directive z Copyright law allows no part of this instruction manual to be reproduced without permission. z The content of this manual are subjec

14 General Operation Tests Alarms and Alarm Silence 1. Connect the monitor to an AC power source. 2. Press the Power Button to turn on the monitor.

15 pulse rate tone decreases. 10. Set QRS volume to Off and return to the monitoring screen. Verify beeping pulse rate tone is no longer audible. 11.

16 Alarm Conditions Adult Pediatric Neonatal TEMP Upper Alarm Limits 39.0°C (102.2°F) 39.0°C (102.2°F) 39.0°C (102.2°F) TEMP Lower Alarm Limits

17 b. Press the Print Button when all the parameter signals display normally. c. Verify the parameter values and waveforms are printed out with 25 m

18 Measurement Parameter Operation Tests ECG Operation 1. Press the Power Button to turn on the monitor. 2. Connect the ECG 3 lead wires to appropr

19 14. Repeat step 9 to 12. 15. Turn off the monitor. Note: The accuracy of the monitor’s ECG measurements is ±1bpm. In the procedure, add the toler

20 Pressure Sensor Accuracy Test Figure 5. Pressure Sensor Accuracy Test 1. Ensure Bio-Tek simulator is in the static pressure test mode. 2. The NI

21 Air Leakage Test Figure 6. Air Leakage Test 1. Ensure the monitor is set up with dummy can-large. 2. Ensure NIBP Test Mode screen is active on

22 1. Ensure the monitor is set up with the dummy can-large. 2. Ensure NIBP Test screen is active on the monitor, then select “Inflation Time Measure

23 Pulse Oximetry Operation 1. Connect the monitor to an AC power source. 2. Turn on the monitor by pressing the Power Button. 3. Connect the SpO2 e

i CONTENTS CONTENTS...

24 z For Mediana module g. Press the PULSE RATE selection button on the SpO2 simulator. The PULSE RATE 240 LED will light. h. The pulse rate will i

25 8. Decrease the respiration rate setting on the respiration simulator to 20 breaths per minute. a. Verify that the monitor displays the respirati

26 z For Sidestream a. Connect the sidestream sampling line to the inlet port located on the metal container on the front of the CO2 module. You wil

27 Safety Tests The monitor safety tests meet the standards of, and are performed in accordance with, IEC 60601-1, Clause 19 (Second Edition, 1988;

28 Note: The analyzer leakage current indication must not exceed the values listed in Table 4. Table 4. Enclosure Leakage Current Test Condition A

29 Patient Leakage Current - Mains Voltage on the Applied Part WARNING: AC power voltage will be present on the applied part terminals during this

30 Patient Auxiliary Current This test measures patient auxiliary current in accordance with IEC60601-1, clause 19, for Class I, type CF equipment. T

31 Verification Check Sheet Record the results of the performance verification on this sheet. Model Name Serial No. Software Version Date Teste

32 SAFETY TEST TEST CONDITIONS LIMIT (uA) RESULTS REMARKS Earth leakage current (NC) 500 Pass / Fail Value: uA Earth leakage c

33 SAFETY TEST TEST CONDITIONS LIMIT (uA) RESULTS REMARKS Patient auxiliary current ECG LL-SpO2 (OS) 50 Pass / Fail Value: uA P

ii Monitor Disassembly ...62

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35 SERVICE MENU AND FACTORY DEFAULT General This section discusses use of the Service menu to configure ‘Save Current Values as Power-On Default’,

36 Figure 10. The access of Service Menu via Setup Menu Note: The access code is 4, 0, 2. It is set at the factory and can not be changed. 5. Rot

37 Note: The monitor is powered off upon selecting “Done” to save any changes in the service menu, and then the changes made to the Power On Default

38 Save Current Values as Power-On Default The current settings become the power-up defaults next time the unit is powered up. Save Factory Default

39 System Information The screen displays several system-related items. Table 11. System Information Tests Description Monitor On Time Displays th

40 Factory Default Settings Factory default settings are divided into adult, pediatric and neonatal as described in Table 12. The patient mode is pr

41 Factory Defaults Parameter Ranges/Selections Adult Pediatric NeonatalNIBP DIA Upper Alarm Limits 15 to 250 mmHg (Adult/Pedi) 2.0 to 33.3 kPa (

42 Factory Defaults Parameter Ranges/Selections Adult Pediatric NeonatalEtCO2 Upper Alarm Limits 1 to 80 mmHg (Adult/Pedi/Neo) (1 mmHg steps) 0.

43 FIRMWARE DOWNLOAD General This section is for the purpose of reloading Firmware into the monitor when the possibility of corrupted Firmware exi

iii Figures Figure 1. Front Panel Components...

44 USB download a. Connect a USB memory drive containing the firmware to the USB port on the left panel of the monitor. b. The monitor will automatic

45 Note: When new firmware downloading is completed, the monitor still keeps the previous settings. Note: If any problem occurs during Firmware dow

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47 TROUBLESHOOTING General This section provides information that can be helpful in troubleshooting the M30 monitor. How to Use This Section If t

48 Troubleshooting Guide Problems with the monitor are separated into categories for further troubleshooting instructions. Note: Taking the recomme

49 1. Power Power problems are related to AC and/or Battery as follows. If the action requires replacement of the components, refer to the Disassemb

50 3. Sound Symptom 3.1: No sound during the POST. Cause or Checkpoint Action Remark Speaker is broken or speaker wire is loose/disconnected. Recon

51 5. NIBP Symptom 5.1: The cuff does not inflate. Cause or Checkpoint Action Remark Cuff or Cuff hose is folded. Unfold the cuff or cuff hose. N

52 9. CO2 Symptom 9.1: Flow rates fall and module is not working properly. Cause or Checkpoint Action Remark Pump is not working properly Check CO

53 11. Firmware Download If an error code appears during the firmware downloading, take the action specified in Table 16. Note: If the alarm message

iv Tables Table 1. Required Equipment ...

54 Error codes Conditions EEE051 SpO2 module DigiCAL communication error EEE255 SpO2 module invalid jumper selection EEE256 SpO2 module beginning of

55 Error codes Conditions EEE802 Analog system temperature module error* EEE803 Analog system error* EEE804 Analog system SpO2 module communicati

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57 DISASSEMBLY GUIDE WARNING: Performance Verification. Do not place the monitor into operation after repair or maintenance has been performed unt

58 M30Front case assembly Rear case assemblyBCFront caseRear caseABatteryB1B2C1Alarm LED board, Alarm windowC2SMPSAC inlet boardKey boardB3ECG conne

59 Replacement Level Supported The replacement level supported for this product is to the printed circuit board (PCB) and major subassembly level. O

60 Optional Printer Disassembly (A2) This section describes the steps that may remove an optional printer in the monitor. If you would like to instal

61 Table 18. Part Descriptions - Printer Board, Printer Body Case, Printer Opener Case, Printer Door Case, Printer Mecha, Printer Door Pin, Printer P

62 Monitor Disassembly This section describes the steps to separate the front and rear case assemblies. Figure 18. Monitor Disassembly Table 19.

63 Figure 19. Monitor Disassembly Table 20. Part Descriptions - Front Case and Rear Case Assembly Part Codes Descriptions Qty - Front case as

1 SAFETY INFORMATION General Safety Information This section contains important safety information related to general use of the M30 monitor. Othe

64 Front Case Disassembly (B) This section describes the items that may be removed on the front case assembly. Figure 20. Front Case Disassembly -

65 B1. Front case disassembly 1. Pull the knob straight out to separate from the monitor. 2. Remove the knob body and knob grip from the knob. 3. Rem

66 Rear Case Disassembly (C) This section describes the items that may be removed on the rear case assembly. Figure 21. Rear Case Disassembly - Ha

67 C1. Rear case disassembly 1. Remove 2 bind-head screws (3×6) on the rear case assembly. 2. Remove 2 round-head screws (3×6) on the inner case asse

68 Figure 22. Rear Case Disassembly - Main Board, Side Connector Cover, ECG Connector, CO2 Connector Table 23. Part Descriptions - Main Board, Si

69 Figure 23. Rear Case Disassembly - ECG & Respiration Module, SpO2 Module, CO2 Module, CPU Module (For Nellcor SpO2 Module) Figure 24. Rea

70 Table 24. Part Descriptions - ECG & Respiration Module, SpO2 Module, CO2 Module, CPU Module Part Codes Descriptions Qty P1094 ECG & Res

71 Figure 25. Rear Case Disassembly - SMPS, AC Inlet, Speaker, ECG Arrester Board, Printer Interface Board, TCP/IP Board, NIBP Module Table 25. Par

72 C6. SMPS disassembly 1. Remove the SMPS control cable, DC power cable, external DC cable and battery cable from the SMPS. 2. Remove 5 round-head s

73 Figure 26. M30 Exploded View

2 Cautions Cautions are identified by the CAUTION symbol shown above. Caution statements identify conditions or practices that could result in da

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75 SPARE PARTS WARNING: Follow local government ordinances and recycle instructions regarding disposal or recycling of device components, includin

76 Figure 27. M30 Exploded View - Spare Parts

77 Table 26. Spare Part List Item Part Code Description 1 B0076 Printer label 2 T1006 Rubber foot 3 T0200 Thermal printer cover 4 T0217 Rear c

78 Item Part Code Description 42 M0015 NIBP module 43 T0210 Inner case 44 E9021 Speaker 45 T0209 Middle case 46 T0201 Power / battery window

79 PACKING FOR SHIPMENT General Instructions To ship the monitor for any reason, follow the instructions in this section. Pack the monitor carefu

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81 SPECIFICATION Display Screen Size 8.5” measured diagonally across the TFT-LCD screen Screen Type/Color Liquid Crystal Display (LCD) Color, Cold

82 Electrical Instrument Power Requirements AC Power 100 to 240VAC, 50/60 Hz, 110VA Fuses qty 2, T3.15 A, 250 volts / T5.0 A, 250 volts Battery Typ

83 Tone Definition High Priority Alarm Tone Volume level Adjustable (level 1~8) Pitch (± 20Hz) 976 Hz Pulse width (± 20msec) 150 msec (IEC60601-1

3 Intended Use for the M30 Monitor The M30 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive blood pressure

84 Measurement Parameters ECG Heart Rate Measurement Range 0, 30 to 300 BPM Accuracy ±1 BPM or ±1% whichever is greater Average Response Time 5 s

85 Heart rate meter accuracy and response to irregular rhythm Provides correct heart rates, as follows: Ventricular bigeminy: 76 to 80 bpm Slow alte

86 Respiration IM Respiration Technique Impedance Pneumography Range 0, 3 to 120 breaths/min Accuracy ±3 breaths/min Leads RA to LA Lead Off Condit

87 Overpressure Protector Adult/Pediatric: 300 mmHg (N.C), 330 mmHg (S.F.C) Neonatal: 150 mmHg (N.C), 165 mmHg (S.F.C) Defibrillator Protection Pro

88 Capnography Parameter Displayed EtCO2, InCO2 Range 0 mmHg ~ 150 mmHg (0kPa ~ 20kPa, 0% ~ 20%) Accuracy 0-40mmHg ±2mmHg of reading 41-70mmHg ±

89 Trends Types Graphical and Tabular Memory saves total 20480 data saves every 20 seconds saves alarm condition saves NIBP Measurements Graphical

90 Compliance Item Compliant with Classification Class I (on AC power) Internally powered (on battery power) Type of protection Type CF – Applied

91 Item Compliant with Oxygen saturation ISO9919:2005 Basic safety & essential performance of pulse oximeter for medical use Temperature monitor

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93 SYSTEM PROCESSING System Overview The M30 monitor is a multi-function monitor for use on adult, pediatric and neonatal patients; ECG, heart rat