SERVICE MANUAL Patient Monitor M30 EU representative TECNOMED 2000 S.L. Valencia, 25 - 28012 Madrid Spain Manufacturer Mediana Co., Ltd. Wonju Medical Industry Park, 1650-1 Donghwa-ri, Munmak-eup, Wonju-si, Gangwon-do, Korea Tel: (82) 2 542 3375 (82) 33 742 5400 Fax: (82) 2 542 7447 (82) 33 742 5483 Part Number: A7135 Rev.0 Revised Date: 03/2009 Printed in Korea Copyright © 2009 All rights reserved.
Directive z z z z 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 contact our service center. The manual will be replaced if any pages are missing or collation is incorrect. Warranty z z z z Please contact your local distributor about the warranty period.
CONTENTS CONTENTS....................................................................................................................................................i SAFETY INFORMATION ..............................................................................................................................1 General Safety Information ...................................................................................................................1 Warnings..............................................
Monitor Disassembly ...........................................................................................................................62 Front Case Disassembly (B) ...............................................................................................................64 Rear Case Disassembly (C)................................................................................................................66 SPARE PARTS .........................................................................
Figures Figure 1. Front Panel Components................................................................................................................................ 5 Figure 2. Rear Panel Components ................................................................................................................................ 6 Figure 3. Left Panel Components .................................................................................................................................. 7 Figure 4.
Tables Table 1. Required Equipment ...................................................................................................................................... 11 Table 2. Parameter Alarm Limit Factory Defaults......................................................................................................... 15 Table 3. Earth Leakage Current Values ....................................................................................................................... 27 Table 4.
SAFETY INFORMATION General Safety Information This section contains important safety information related to general use of the M30 monitor. Other important safety information appears throughout the manual. The M30 may be referred to as the monitor throughout this manual. Important! Before use, carefully read this manual, the Instruction Manual, accessory directions for use, and all precautionary information and specifications. Warnings Warnings are identified by the WARNING symbol shown above.
Cautions Cautions are identified by the CAUTION symbol shown above. Caution statements identify conditions or practices that could result in damage to the equipment or other property. CAUTION: Observe ESD (electrostatic discharge) precautions when working within the unit and/or when disassembling and reassembling the monitor and when handling any of the components of the monitor. CAUTION: When reassembling the monitor, over-tightening screws could strip the screw holes in the cases, rendering it unusable.
Intended Use for the M30 Monitor The M30 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (systolic, diastolic and mean arterial pressures) (NIBP) functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration (RR), capnography (EtCO2 and InCO2) and temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.
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 that no battery is installed. Note: The alphabet “A” can be added as the last digit of reference number in accordance with the region.
Front Panel Components 1 2 3 4 5 1 2 3 4 5 6 Alarm indicator LCD AC indicator Battery charging indicator Power button 7 8 6 7 8 9 10 9 10 NIBP start/stop button Print button Home button Alarm stop button Jog dial Figure 1.
Rear Panel Components 1 8 2 3 4 1 2 3 4 5 6 7 8 5 6 Handle AC power connector Equipotential terminal DC power connector Speaker Battery cover LAN port Vent Cover Figure 2.
Left Panel Components 1 2 3 4 1 2 3 4 Printer (option) USB port (mini USB B Type) USB port (USB A Type) RJ11 port Figure 3.
Right Panel Components 1 2 3 4 5 1 2 3 4 5 ECG connector SpO2 connector NIBP connector Temperature connector CO2 connector (Option) Figure 4.
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 liquid or clean with caustic or abrasive cleaners. Cleaning The monitor may be surface-cleaned by using a soft cloth dampened with either a commercial, nonabrasive cleaner or one of the solutions listed below. Lightly wipe the top, bottom and front surfaces of the monitor.
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, connect the monitor to an AC outlet as described in the Battery Charge paragraph in this service manual or the Battery Operation section of the operation manual. Note: Storing the monitor for a long period without charging the battery may degrade the battery capacity. The battery may require a full charge/discharge cycle to restore normal capacity.
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 monitor covers. All tests except the battery charge and battery discharge tests must be performed as the last operation before the monitor is returned to the user. If the monitor fails to perform as specified in any test, repairs must be made to correct the problem before the monitor is returned to the user.
Performance Tests The battery charge and battery discharge test should be performed before 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 institution). Before performing the battery discharge test, ensure that the battery is fully charged. This section is written using factory defaults as power-up.
displayed about 15 minutes before battery fully discharges. 11. Allow the monitor to operate until it automatically powers down due to the low battery condition. Verify that the high priority alarm occurs and the alarm message “Critically Low-Battery condition” is displayed about 5 minutes before the monitor automatically shuts down. 12. If the monitor passes this test, immediately recharge the battery. (see “Battery Charge.”) Power-On Self-Test (POST) 1.
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. 3. Connect the SpO2 simulator to the SpO2 extension cable and connect the cable to the monitor. 4. Set the SpO2 simulator as follows: SpO2 of 75% and pulse rate of 60bpm. 5. Verify the following monitor reaction: a. The pulse amplitude indicator begins to track artificial pulse signal from the SpO2 simulator. b.
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. Return QRS volume to a comfortable level. Sensor LED Test This procedure uses normal system components to test circuit operation. An SpO2 sensor, DS-100A is used to examine LED intensity control. The red LED is used to verify intensity modulation caused by the LED intensity control circuit. 1. Connect the monitor to an AC power source. 2.
Alarm Conditions TEMP Upper Alarm Limits Adult 39.0°C (102.2°F) TEMP Lower Alarm Limits 36.0 °F (96.8 °F) EtCO2 Upper Alarm Limits EtCO2 Lower Alarm Limits InCO2 Upper Alarm Limits InCO2 Upper Alarm Limits 80 mmHg 0 mmHg 20 mmHg 0 mmHg Pediatric 39.0°C (102.2°F) 36.0 °F (96.8 °F) 80mmHg 0mmHg 20 mmHg 0 mmHg Neonatal 39.0°C (102.2°F) 36.0 °F (96.8 °F) 80mmHg 0 mmHg 20 mmHg 0 mmHg 1. Turn on the monitor under Factory default settings. 2. Select the Alarm Limits Icon to display the Alarm Limits Menu.
b. Press the Print Button when all the parameter signals display normally. c. Verify the parameter values and waveforms are printed out with 25 mm/s. d. Set Print Speed to 50 mm/s. e. Press the Print Button when all the parameter signals display normally. f. Verify that the parameter values and waveforms are printed out with 50 mm/s. g. Verify the two ECG waveforms are printed out. h. Repeat this test for other selections. 8. Test #5: Print-On-Alarm a.
Measurement Parameter Operation Tests ECG Operation 1. Press the Power Button to turn on the monitor. 2. Connect the ECG 3 lead wires to appropriate terminals on the ECG simulator. 3. Connect lead wires to the ECG cable. 4. Connect the ECG cable to the ECG connector on the monitor’s right panel. 5. Set the ECG simulator as follows: z z z z z Heart rate: 30bpm Amplitude: 1millivolt Lead select: II Normal sinus rhythm Adult mode 6. After normal power-up sequence, verify the following monitor reactions: a.
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 tolerance of the simulator to the acceptable range of readings. NIBP Operation These tests verify the functionality of the M30 pneumatic system. The Bio-Tek simulator or any equivalent NIBP simulator is required to perform these tests. Each of the tests must be performed to verify pneumatic system functionality. Over-Pressure Test 1.
Pressure Sensor Accuracy Test Figure 5. Pressure Sensor Accuracy Test 1. Ensure Bio-Tek simulator is in the static pressure test mode. 2. The NIBP test screen is active on the monitor, then select Pressure Sensor Accuracy Test by the jog dial. 3. Press Select button on the simulator until simulator displays “Pressure Source Set Test Pressure”. Adjust the pressure on the simulator for 250, 150, 50 and 0 mmHg. 4. Press Start Pump button on the simulator. The simulator will begin to pressurize.
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 the monitor, then select Air Leakage Test by the jog dial. 3. The monitor displays the pressure of approximately 290 mmHg automatically. 4. The test result displays at the test completion. The initial pressure value at 1 minute is displayed after the test start and the air leakage value at further 3 minutes after the 1 minute elapsed.
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 Measurement” by the jog dial. 3. The monitor displays the pressure of approximately 290 mmHg automatically and measures the inflation time in seconds. 4. The test result displays at the test completion. Note: The test will have been successfully completed if the inflation time is 4.0 to 7.5 seconds (to 250 mmHg). Deflation Rate Measurement Figure 8.
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 extension cable to the SpO2 connector on the monitor’s right panel after the monitor completes POST. 4. Connect the SpO2 simulator to the other end of the SpO2 extension cable. 5. Test #1: SpO2 z For Nellcor module a. Press the %SpO2 selection button on the SpO2 simulator. The %SpO2 90 LED will light: b.
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 increase to 240 bpm. The test pass criteria is 238 to 242 bpm. i. The monitor will display: - 92%SpO2 - 240 bpm - alarm: “High SpO2 limits violated” message will display and the HR/PR area will flash, indicating pulse rate is above default upper alarm limit (medium priority alarm). j. Press the PULSE RATE selection button on the SpO2 simulator.
8. Decrease the respiration rate setting on the respiration simulator to 20 breaths per minute. a. Verify that the monitor displays the respiration rate of 20 ±3 breaths per minute. Note: The accuracy of Respiration measurements is ±3 breaths per minute. In the procedure above, add the tolerance of the simulator to the acceptable range of readings. Temperature Operation 1. Press the Power Button to turn on the monitor. 2.
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 will hear a click when properly inserted. b. A “CO2 - Sensor Warming-up” message displays for up to 2 minutes, depending on the temperature of the environment, the temperature of the module, and the temperature of the sensor. c. Breathe through the CO2 airway adapter for five slow breaths. Verify that the displayed waveform rises and falls accordingly. d.
Safety Tests The monitor safety tests meet the standards of, and are performed in accordance with, IEC 60601-1, Clause 19 (Second Edition, 1988; Amendment 1, 1991-11, Amendment 2, 1995-03), EN60601-1 for instruments classified as Class I and Type CF. Protective Earth Continuity This test checks the integrity of the power cord ground wire from the AC plug to the instrument chassis ground. The current used for this test is less than or equal to 4 Volts RMS, 50 to 60 Hz, and 25 Amperes. 1.
Note: The analyzer leakage current indication must not exceed the values listed in Table 4. Table 4. Enclosure Leakage Current Test Condition Normal Condition (NC) SFC Open Supply (OS) SFC Open Earth (SFC OE) Normal Condition RM (NCRM) SFC Open Supply RM (SFC OSRM) SFC Open Earth RM (SFC OERM) Allowable Leakage Current (microamps) 100 500 500 100 500 500 Patient Leakage Current This test measures patient leakage current in accordance with IEC60601-1, clause 19, for Class I, Type CF equipment.
Patient Leakage Current - Mains Voltage on the Applied Part WARNING: AC power voltage will be present on the applied part terminals during this test. Exercise caution to avoid electrical shock hazard. WARNING: Do not touch the patient leads clips or the simulator parts connected to patient leads during this test as an electrical shock will occur. This test measures patient leakage current in accordance with IEC60601-1, clause 19, for Class I, type CF equipment.
Patient Auxiliary Current This test measures patient auxiliary current in accordance with IEC60601-1, clause 19, for Class I, type CF equipment. The applied voltage for IEC60601-1 is 264 volts, 50 to 60 Hz. Patient auxiliary current is measured between each ECG test lead and between each sensor connection for all possible connections. Note: Keep the patient test cable length as short as possible during the leakage test.
Verification Check Sheet Record the results of the performance verification on this sheet. Model Name Serial No.
SAFETY TEST TEST CONDITIONS Earth leakage current (NC) Earth leakage current (SFC OS) Earth leakage current (NCRM) Earth leakage current (SFC OSRM) Enclosure leakage current (NC) Enclosure leakage current (OS) Enclosure leakage current (SFC OE) Enclosure leakage current (NCRM) Enclosure leakage current (SFC OSRM) Enclosure leakage current (SFC OERM) Patient leakage current (NC) Patient leakage current (OS) Patient leakage current (SFC OE) Patient leakage current (NCRM) Patient leakage current (SFC OSRM) Pat
SAFETY TEST TEST CONDITIONS Patient auxiliary current ECG LL-SpO2 (OS) Patient auxiliary current ECG LL-SpO2 (SFC OE) Patient auxiliary current ECG LL-SpO2 (NCRM) Patient auxiliary current ECG LL-SpO2 (SFC OSRM) Patient auxiliary current ECG LL-SpO2 (SFC OERM) Patient auxiliary current ECG RA-SpO2 (NC) Patient auxiliary current ECG RA-SpO2 (OS) Patient auxiliary current ECG RA-SpO2 (SFC OE) Patient auxiliary current ECG RA-SpO2 (NCRM) Patient auxiliary current ECG RA-SpO2 (SFC OSRM) Patient auxiliary curren
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SERVICE MENU AND FACTORY DEFAULT General This section discusses use of the Service menu to configure ‘Save Current Values as Power-On Default’, ‘Save Factory Default Setting as Power-On Default’, ‘Alarm Suspension Period’, ‘Alarm Silence Period’, ‘Alarm Reminder Tone’, ‘Audible Alarm Type’, ‘Language’, ‘NIBP TEST MODE’ and ‘System Information'. Also, this section explains briefly the factory default settings.
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. Rotate the jog dial to highlight the top of the digits. Press the jog dial to enter the Pass Code. 6. Rotate the jog dial until “6” appears, then press the jog dial. 7. Repeat step 5-6 to enter the access code "4" "0" "2". Figure 11. Service Menu 8. The Service Menu will now be present. The available Service Menu items are explained in Figure 11 and Table 9.
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 Defaults will be in effect next time the monitor is powered up. Table 9.
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 Setting as Power-On Default The factory default settings become the power-up defaults next time the unit us powered up. See Table 12. Alarm Suspension Period If the Alarm Suspension Period is set to anything other than OFF or Indefinite, the audible alarm is not activated for the specified time interval by pressing and holding the Alarm Stop Button for 2 seconds.
System Information The screen displays several system-related items. Table 11. System Information Tests Monitor On Time Recorder On Time Battery Deep Discharges System Software Version Module Version (Sub CPU, ECG, SpO2, NIBP, Temperature, EtCO2) Description Displays the number of hours, rounded to the nearest hour, that the monitor has been operational. Displays the number of hours, rounded to the nearest hour, that the Recorder has been operational.
Factory Default Settings Factory default settings are divided into adult, pediatric and neonatal as described in Table 12. The patient mode is preset to “Adult” mode. Alarm limits will be automatically changed to the default settings for each patient mode as the mode is changed to Adult, Pediatric or Neonatal mode. Table 12.
Parameter NIBP DIA Upper Alarm Limits NIBP DIA Lower Alarm Limits NIBP MAP Upper Alarm Limits NIBP MAP Lower Alarm Limits Ranges/Selections 15 to 250 mmHg (Adult/Pedi) 2.0 to 33.3 kPa (Adult/Pedi) 25 to 90 mmHg (Neo) 3.3 to 12.0 kPa (Neo) (5 mmHg / 0.6 or 0.7 kPa steps) 10 to 245 mmHg (Adult/Pedi) 1.3 to 32.6 kPa (Adult/Pedi) 20 ~85 mmHg (Neo) 2.6 to 11.3 kPa (Neo) (5 mmHg / 0.6 or 0.7 kPa steps) 25 to 260 mmHg (Adult/Pedi) 3.3 to 34.6 kPa (Adult/Pedi) 35 to 110 mmHg (Neo) 4.6 to 14.
Parameter EtCO2 Upper Alarm Limits EtCO2 Lower Alarm Limits InCO2 Upper Alarm Limits InCO2 Lower Alarm Limits Ranges/Selections 1 to 80 mmHg (Adult/Pedi/Neo) (1 mmHg steps) 0.13 to 10.7 kPa (Adult/Pedi/Neo) (0.13 kPa steps) 0.13 to 10.5 % (Adult/Pedi/Neo) (o.13 % steps) 0 to 79 mmHg (Adult/Pedi/Neo) (1 mmHg steps) 0 to 10.5 kPa (Adult/Pedi/Neo) (0.13 kPa steps) 0 to 10.4 % (Adult/Pedi/Neo) (o.13 % steps) 1 to 20 mmHg (Adult/Pedi/Neo) (1 mmHg steps) 0.13 to 2.7 kPa (Adult/Pedi/Neo) (0.13 kPa steps) 0.
FIRMWARE DOWNLOAD General This section is for the purpose of reloading Firmware into the monitor when the possibility of corrupted Firmware exists, or updating Firmware with a new system revision (system/device version). Call Mediana Technical Service Department for the latest version of Firmware utility required. Note: The firmware download can be performed via USB or TCP/IP.
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 automatically run the firmware download once the USB memory is detected. TCP/IP download a. Connect a LAN cable to the LAN port on the rear panel of the monitor. b. Run the downloading software on the PC. c. Perform the firmware download according to the software instructions. 4.
Note: When new firmware downloading is completed, the monitor still keeps the previous settings. Note: If any problem occurs during Firmware downloading, refer to Firmware Download in the Troubleshooting section.
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TROUBLESHOOTING General This section provides information that can be helpful in troubleshooting the M30 monitor. How to Use This Section If the Unit is not functioning properly, please check on the following items before calling for repair service. Use this section in conjunction with the Performance Verification section and the Spare Parts section. To remove and replace a part suspected to be trouble, follow the instructions in the Disassembly Guide section.
Troubleshooting Guide Problems with the 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 resolved by calling Mediana Technical Service Department. Table 15. Problem Categories Categories 1. Power Symptoms 1.1 : Monitor will not turn on though the Power button is pressed. 1.2 : Monitor does not power on with battery.
1. Power Power problems are related to AC and/or Battery as follows. If the action requires replacement of the components, refer to the Disassembly Guide section. CAUTION: Electrical shock hazard. Disconnect the power cord from the monitor before attempting to open or disassemble the monitor. Symptom 1.1: Monitor will not turn on though the power button is pressed. Cause or Checkpoint - AC line power cord is disconnected. - Battery is depleted or defective.
3. Sound Symptom 3.1: No sound during the POST. Cause or Checkpoint Speaker is broken or speaker wire is loose/disconnected. Main Board is malfunctioning. Action Reconnect the wire or replace the speaker. Replace the Main Board. Remark Symptom 3.2: Alarm is not silenced. Cause or Checkpoint Key assembly board is broken. Main Board is broken. Action Replace the key assembly board. Replace the Main Board. Remark Symptom 3.3:Buzzer Alarm goes off during the POST.
5. NIBP Symptom 5.1: The cuff does not inflate. Cause or Checkpoint Cuff or Cuff hose is folded. NIBP tube inside of the monitor is blocked or kinked. NIBP module is broken. Main board is broken. Action Unfold the cuff or cuff hose. Check the tube assembly between NIBP module and hose fitting. Replace the NIBP module. Replace the Main Board. Remark 6. SpO2 Symptom 6.1: The SpO2 sensor does not light. Cause or Checkpoint The connection between SpO2 sensor and extension cable is loose.
9. CO2 Symptom 9.1: Flow rates fall and module is not working properly. Cause or Checkpoint Pump is not working properly The Flow rates fall outside of the normal operating range Message “CO2 - Sampling Line Disconnected” Action Check CO2 module Sampling line is crimped or pinched. Sampling line is damaged. Check exhaust port. Remove the connector for inspection. Remark 10. ECG Symptom 10.1: Rapid, large and erratic detections.
11. Firmware Download If an error code appears during the firmware downloading, take the action specified in Table 16. Note: If the alarm message still appears, take monitor out of service and contact Mediana Technical Service Department for advice on remedial action. Table 16. Firmware Downloading Error Codes Code E.00.0001 E.00.0002 E.00.0003 E.00.0004 E.00.0005 E.01.0003 E.02.0003 E.01.0005 E.02.0005 E.01.0007 Description USB is not used. Section.muf file not found or break. Ver.
Error codes EEE051 EEE255 EEE256 EEE257 EEE258 EEE259 EEE260 EEE261 EEE262 EEE263 EEE264 EEE265 EEE266 EEE267 EEE268 EEE269 EEE270 EEE271 EEE272 EEE273 EEE274 EEE275 EEE276 EEE277 EEE281 EEE282 EEE283 EEE284 EEE285 EEE286 EEE287 EEE288 EEE289 EEE401 EEE402 EEE403 EEE404 EEE405 EEE406 EEE407 EEE499 EEE700 EEE701 EEE702 EEE703 EEE704 EEE705 EEE706 EEE801 54 Conditions SpO2 module DigiCAL communication error SpO2 module invalid jumper selection SpO2 module beginning of packet missing SpO2 module packet start
Error codes EEE802 EEE803 EEE804 EEE905 EEE906 EEE907 EEE910 Conditions Analog system temperature module error* Analog system error* Analog system SpO2 module communication error* Printer communication error* Battery status checking error* RTC error* 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 Stop Button.
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DISASSEMBLY GUIDE WARNING: Performance Verification. Do not place the monitor into operation after repair or maintenance has been performed until all Performance Tests and Safety Tests listed in the Performance Verification section of this service manual have been performed. Failure to perform all tests could result in erroneous monitor readings. WARNING: Before attempting to open or disassemble the monitor, disconnect the power cord from the monitor.
M30 A A1 Battery B A2 C Front case assembly Rear case assembly Printer B1 Front case B2 LCD, LCD inverter B3 Key board C1 Rear case C2 Alarm LED board, Alarm window C3 Handle C4 Side connector cover C4-1 ECG connector C5 Main Board C5-1 CPU board C5-2 ECG & Resp module C5-3 Temp module C5-4 SpO2 module C5-5 CO2 module C6 SMPS C6-1 AC inlet board C7 Speaker C8 ECG arrester board C9 Printer interface board C10 TCP/IP board C11 NIBP module Figure 14.
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 with a known good PCB. Check to see if the trouble symptom persists, swap back the replacement PCB with the suspected malfunctioning PCB (the original PCB that was installed when you started trouble shooting) and continue troubleshooting as directed in this section.
Optional Printer Disassembly (A2) This section describes the steps that may remove an optional printer in the monitor. If you would like to install a printer, follow the reverse sequence of the procedures. Figure 16. Printer Disassembly Figure 17.
Table 18. Part Descriptions - Printer Board, Printer Body Case, Printer Opener Case, Printer Door Case, Printer Mecha, Printer Door Pin, Printer Paper Part Codes A0132 M4031 T0197 T0198 T0199 M4020 T4109 B0076 Descriptions Thermal printer paper (50mm) Thermal printer board Thermal printer body case Thermal printer opener case Thermal printer door case Thermal printer mecha Thermal printer door pin (2mm) Thermal printer label Qty 1 1 1 1 1 1 2 1 A2. Printer disassembly 1.
Monitor Disassembly This section describes the steps to separate the front and rear case assemblies. Figure 18. Monitor Disassembly Table 19. Part Descriptions - Printer Cover Part Codes B0076 T0200 Descriptions Thermal printer label Thermal printer cover Qty 1 1 Before steps B and C (1) 1. Remove the printer label on the printer cover. 2. Remove 2 round-head screws (3×50) on the printer cover and then remove the printer cover from the monitor.
Figure 19. Monitor Disassembly Table 20. Part Descriptions - Front Case and Rear Case Assembly Part Codes T2017 T1006 Descriptions Front case assembly (A) Rear case assembly (B) Rear case cover Rubber foot Qty 1 1 1 4 Before steps B and C (2) 1. Remove the 4 rubber feet from the rear case. 2. Remove 2 bind-head screws (3x6) on the rear case cover. 3. Separate the rear case cover from the rear case. 4. Remove 2 bind-head screws (3x10), 1 bind-head screw (3x6) and 2 flat-head screws (3x6) on the rear case.
Front Case Disassembly (B) This section describes the items that may be removed on the front case assembly. Figure 20. Front Case Disassembly - Front Case, LCD, Key Board Table 21.
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. Remove the 6 round-head screws (3×6) from the front case assembly. 4. Separate the front case from the middle case assembly. B2. LCD disassembly 1. Remove the LCD data cable and the inverter cable from the middle case. 2. Separate the LCD, LCD window, LCD ferrite core and LCD inverter from the middle case. B3. Key board disassembly 1.
Rear Case Disassembly (C) This section describes the items that may be removed on the rear case assembly. Figure 21. Rear Case Disassembly - Handle, Alarm LED Board, Alarm Window, Inner Case Table 22.
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 assembly. 3. Separate the inner case assembly from the rear case. 4. Remove the vent cover and alarm window from the rear case. C2. Alarm LED board and Alarm window disassembly 1. Remove the alarm LED cable from the rear case assembly. 2. Remove the alarm LED board from the rear case assembly. C3. Handle disassembly 1.
Figure 22. Rear Case Disassembly - Main Board, Side Connector Cover, ECG Connector, CO2 Connector Table 23. Part Descriptions - Main Board, Side Connector Cover, ECG Connector, CO2 Connector Part Codes P1105 / P1093 T0212 E4114 E4231 W0158 Descriptions Main Board for Nellcor SpO2 module / for Mediana SpO2 module Side connector cover Luer fitting/NIBP connector ECG connector (6pin) EtCO2 connector (8pin) Qty 1/1 1 1 1 1 C4. Side connector cover disassembly 1. Remove the side connector from the inner case.
Figure 23. Rear Case Disassembly - ECG & Respiration Module, SpO2 Module, CO2 Module, CPU Module (For Nellcor SpO2 Module) Figure 24.
Table 24. Part Descriptions - ECG & Respiration Module, SpO2 Module, CO2 Module, CPU Module Part Codes P1094 P1098 P1099 M0009 / P1102 P1117 Descriptions ECG & Respiration module CPU board Temperature module Nellcor SpO2 module / Mediana SpO2 module CO2 module (Option) Qty 1 1 1 1/1 1 C5-1. CPU board disassembly 1. Remove 6 round-head screws (3x4) from the CPU board and the Main Board to remove 3 supporters fastening the CPU board. 2. Remove the CPU board from the Main Board. C5-2.
Figure 25. Rear Case Disassembly - SMPS, AC Inlet, Speaker, ECG Arrester Board, Printer Interface Board, TCP/IP Board, NIBP Module Table 25.
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 screws (3x6) from the SMPS. 3. Separate the SMPS from the inner case. C6-1. AC inlet board disassembly 1. Remove the AC holder from the SMPS. 2. Remove 2 round-head screws (3x6) from the AC inlet board. 3. Separate the AC inlet cable from the AC inlet board. 4. Remove the AC inlet board from the AC holder. 5. Remove the GND pin form the AC inlet board. C7.
Figure 26.
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SPARE PARTS WARNING: 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 26. “Item No.” corresponds to the circled callout numbers in Figure 27. Obtaining Replacement Parts Mediana provides technical assistance information and replacement parts. To obtain replacement parts, contact Mediana Technical Service Department.
Figure 27.
Table 26.
Item 42 Part Code M0015 Description NIBP module 43 T0210 Inner case 44 E9021 Speaker 45 T0209 Middle case 46 T0201 Power / battery window 47 T0214 Button 48 T0224 Button ring (green) 49 T0223 Button ring (orange) 50 T0213 Button ring (blue) 51 T0225 Button ring (white) 52 M8002 LCD inverter 53 P1095 Key assembly board 54 T0207 Front case 55 M4048 TFT-LCD 56 T0333 LCD window 57 E5012 LCD ferrite core 58 T0245 Knob body 59 T0246 Knob grip 60 W0194 LCD da
PACKING FOR SHIPMENT General Instructions To ship the monitor for any reason, follow the instructions in this section. Pack the monitor carefully. Failure to follow the instructions in this section may result in loss or damage not covered by the Mediana Limited Warranty. See Limited Warranty information in the M30 Instruction Manual. If the original shipping carton is not available, use another suitable carton. Returning the M30 Monitor Pack the monitor in its original shipping carton.
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SPECIFICATION Display Screen Size Screen Type/Color Resolution Number of traces 8.
Electrical Power Requirements Fuses Type Operating time Voltage/Capacity Recharge Life Cycle Compliance Instrument AC Power 100 to 240VAC, 50/60 Hz, 110VA qty 2, T3.15 A, 250 volts / T5.0 A, 250 volts Battery Li-ion battery 1 hour (2200mAh), 3 hours (4400mAh), 5 hours (6600mAh) At the following condition: no printing no external communication no audible alarm sound one NIBP measurement per 15 minutes at 25°C 11.1 V / 2200 mAh (1 hour type) 11.1 V / 4400 mAh (3 hours type) 11.
Tone Definition Volume level Pitch (± 20Hz) Pulse width (± 20msec) Number of pulses Repetitions Volume level Pitch (± 20Hz) Pulse width (± 20msec) Number of pulses Repetitions Volume level Pitch (± 20Hz) Pulse width (± 20msec) Number of pulses Volume level Pitch (± 20Hz) Pulse width (± 20msec) Number of pulses Repetitions Volume level Pitch (± 20Hz) Pulse width (± 20msec) Number of pulses Repetitions Volume level Pitch (± 20Hz) Pulse width (± 20msec) Number of pulses Repetitions Volume level Pitch (± 20Hz)
Measurement Parameters ECG Measurement Range Accuracy Average Response Time Tall T-wave Rejection Leads Lead Off Detection Pacer Detection Heart Rate 0, 30 to 300 BPM ±1 BPM or ±1% whichever is greater 5 seconds (from 80 to120 BPM) 9 seconds (from 80 to 40 BPM) maximum T-wave amplitude 1.8 mV ECG (Electrocardiograph) 3 / 5 Lead Lead I, II, III, aVR, aVL, aVF, V (Chest Lead) Detected and displayed Detect pacer pulses of ±2mV to ±700mV with pulse widths of 0.
Heart rate meter accuracy and response to irregular rhythm Respiration, leads-off sensing, and active noise suppression Time to alarm for cardiac standstill Time to alarm for low heart rate Time to alarm for high heart rate Time to alarm for tachycardia Provides correct heart rates, as follows: Ventricular bigeminy: 76 to 80 bpm Slow alternating ventricular bigeminy: 55 to 60 bpm Rapid alternating ventricular bigeminy: 116 to 117 bpm Bidirectional systoles: 86 to 91 bpm Respiration frequency: 61 to 62 kHz
Respiration Technique Range Accuracy Leads Lead Off Condition Defibrillator Protection Technique Range Accuracy Display Sweep Speeds Wave Size IM Respiration Impedance Pneumography 0, 3 to 120 breaths/min ±3 breaths/min RA to LA Detected and displayed Protected AW Respiration Nondispresive Infrared Spectroscopy 0 to 50 breaths/min ±1 breaths/min 6.25 mm/s, 12.5 mm/s, 25.
Overpressure Protector Defibrillator Protection Measurement Speed Adult/Pediatric: 300 mmHg (N.C), 330 mmHg (S.F.C) Neonatal: 150 mmHg (N.C), 165 mmHg (S.F.
Capnography Parameter Displayed Range Accuracy Display Accuracy Response Time Baromatric Pressure Correction Gas Compensation Stability and drift Accuracy Change for interfering Gases and Vapors Anesthetic and interfering agents Warm Up Time Sweep Speeds Sound Noise Level EtCO2, InCO2 0 mmHg ~ 150 mmHg (0kPa ~ 20kPa, 0% ~ 20%) 0-40mmHg ±2mmHg of reading 41-70mmHg ±5% of reading 71-100mmHg ±8% of reading 101-150mmHg ±10% of reading ±2mmHg Mainstream: Less than 60ms Sidestream: Less than 3sec. -152.
Trends Types Memory Graphical Format Tabular Format Display Display Time Interval Graphical and Tabular saves total 20480 data saves every 20 seconds saves alarm condition saves NIBP Measurements Total 2 graphs z a graph for HR/PR, Resp, SpO2 parameters z a graph for NIBP, Temp parameters User-selectable each parameter to be desired One table for all parameters 10 lists 20 sec, 1, 2, 3, 5, 10, 20 minutes 89
Compliance Item Classification Type of protection Mode of operation Degree of protection General Compliant with Class I (on AC power) Internally powered (on battery power) Type CF – Applied part Continuous IPX1 (provided by enclosures) 93/42/EEC Directives for medical devices 21CFR820 Code of federal regulations 2002/96/EC Waste electrical and electronic equipment directive (WEEE) 91/157/EEC Battery declaration directive 93/86/EEC Battery disposal directive 2006/66/EC Battery directive ISO13485:2003 Quali
Item Oxygen saturation Temperature monitoring Capnography Electromagnetic compatibility Package Reliability Labeling Marking Compliant with ISO9919:2005 Basic safety & essential performance of pulse oximeter for medical use EN12470-4:2000 Performance of electrical thermometers for continuous Measurement ISO21647:2004 Particular requirements for the basic safety and essential performance of respiratory gas monitors IEC60601-1, sub clause 36, and IEC60601-1-2:2001+A1:2004 Electromagnetic compatibility-re
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SYSTEM PROCESSING System Overview The M30 monitor is a multi-function monitor for use on adult, pediatric and neonatal patients; ECG, heart rate, non invasive blood pressures, arterial oxygen saturation, pulse rate, respiration rate, capnography, and temperature.
Unit Description z Power unit: consists of SMPS and battery charger AC 100 - 240V 50/60Hz AC-DC Vout 10V~15V 2A FET DC/DC on,off V Stanby Li-ion Battery 3S1P/2200mAh 3S2P/4400mAh 3S3P/6600mAh Charger Charging LED Charged LED FUSE AC Detect Ex-DC Detect EXTERNAL DC 13V~15V Ex-DC Battery Detect FUSE Figure 29. Power Unit Block Diagram z Processor unit: consists of Samsung® S3C2440A CPU, SDRAM, Boot ROM and Flash.
z User-control unit: consists of jog dial, 5 functional buttons, optical encoder, power on indicator LED, Battery charging indicator LED and battery charging status indicator LED. Buttons S3C2440A(Processor Unit) general purpose port Optical Encoder with Push Button S3C2440A(Processor Unit) external interrupt Figure 31. User-Control Unit Block Diagram z Sound unit: consists of S3C2440A, ARM CPU, 2-channel amplifiers and speaker.
z GUI (graphic user interface) unit: consists of TFT LCD, inverter for backlight and internal LCD controller. 8.5" TFT LCD TTL data bus ht O klig Bac F N/O CPU S3C2440A F Inverter For backlight Figure 34. GUI Unit Block Diagram z Thermal Printer unit: prints data records. Error Signal Thermal Printer Asynchronous Serial Communication with Communication Unit Figure 35. Thermal Printer Unit Block Diagram z NIBP unit: measures non-invasive blood pressure data.
z ECG unit: measures electrocardiographic waveform data. RA Patient Cable Protection Circuirt Input Buffer & Filter Lead off detector Driven circuit saturation detector LA Lead off detector Driven circuit saturation detector LL Lead off detector Driven circuit saturation detector C Lead off detector saturation detector RL Lead off detector Driven circuit saturation detector Lead I Instrument Amp. Gain Amp. Filter Isolation DC +11Vdc ±1 Vdc Lead II III , Instrument Amp. Gain Amp .
z Temperature unit: measures temperature data. Isolation DC +11Vdc ±1 Vdc Isolation DC/DC Temperature Probe Patient Isolation RC Circuit MSP430F1121A Serial Data AD Conversion High Accuracy Resistor Photocoupler Figure 40. Temperature Unit Block Diagram z CO2 unit: measures CO2 data. Patient Isolation DC +5V Main Processor Main Processor Isolation DC/DC Photocoupler Isolation DC +5Vdc ±0.5 Vdc Patient RS-232 Communication connector Port atomsphere sensor Figure 41.
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’s body. The information on heart activity carried by these signals varies with the placing of the electrodes.
● Oscillometric Response (Pressure Pulses) MAP Distole Systole Systole Distole MAP Systole TIME ● Cuff Pressure MAP Distole TIME Overall Accuracy Discussion Overall system accuracy shall be determined by considering various influences of the pressure sensor accuracy, motion artifacts, other artifacts created by the pressure valve, technical errors of electrical components, and the origin error of oscillometric method.
SYSTOLIC PRESSURE Mean difference(MD): 0 mmHg Standard deviation(SD): 6 mmHg Difference between test and reference methods (mmHg) 20 15 mean + 2 SD 10 5 0 mean -5 -10 mean - 2 SD -15 -20 100 120 140 160 180 200 Average of test and reference methods (mmHg) (EXAMPLE) Agreement between test and reference methods for systolic pressure. Hypothetical data SpO2 Processing Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed.
No Calibration Required (Mediana module) Pulse oximeter requires neither production, nor user calibration. The relationship between light absorption by hemoglobin and reported SpO2 is stored in the device memory during manufacturing of the device. This relationship is established for given LED wavelengths and given sensor construction, by comparison with blood gas measurements, using statistically significant number of samples.
SpO2 Accuracy (Mediana module) The saturation (SpO2) accuracy specification was proven by comparisons with the arterial blood gas measurements. Statistically significant number of samples at SpO2 levels ranging from 70% to 99% was collected on male and female volunteers, with different skin colors. Pulse rate accuracy specification was proven by laboratory simulator tests, where oximeter was connected to the Oximetry simulator, set to the precise number of pulses per minute.
Temperature Processing Measurement of patient temperature is accomplished by processing the signal from a probe containing a resistor whose resistance is temperature dependent. The class of such components is called thermistor. Temperature measurement used by the M30 monitor is based on a thermistor whose resistance is inversely proportional to its temperature. By measuring the thermistor’s resistance, its temperature can be calculated.
