Mediana P10 Service Manual
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Mediana P10 Service Manual

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SERVICE MANUAL
P10
Pulse Oximeter
EU representative
OBELIS S.A
Bd. Général Wahis, 53, 1030 Brussels, Belgium
Manufacturer
Mediana Co., Ltd.
132, Donghwagongdan-ro,
Munmak-eup, Wonju-si, Gangwon-do, Korea
Tel: (82) 2 542 3375 (82) 33 742 5400
Fax: (82) 2 542 7447 (82) 33 742 5483
Part Number: A7137-4
Revised Date: 0414
Copyright © 2014 All rights reserved.

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  • Page 1 Pulse Oximeter EU representative OBELIS S.A Bd. Général Wahis, 53, 1030 Brussels, Belgium Manufacturer Mediana Co., Ltd. 132, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Korea Tel: (82) 2 542 3375 (82) 33 742 5400 Fax: (82) 2 542 7447 (82) 33 742 5483...
  • Page 2  Note that mobile phones should not be used in the vicinity of the P10. Note, however, any device not complying to the EMC standard that is used with the P10 renders the P10 as non-compliable to the EMC standard.

  • Page 3: Table Of Contents

    Warnings ..............................1 Cautions ..............................2 Manual Overview ........................... 2 Related Documents ..........................2 Intended Use for the P10 pulse oximeter ....................3 Front Panel Components ........................4 Rear Panel Components ........................5 Right and Left Panel Components ......................6 Top and Bottom Panel Components ......................
  • Page 4 Figure 13. Front Case Disassembly - Front cover, Key pad ..................32 Figure 14. Rear Case Disassembly - Middle cover ...................... 33 Figure 15. Rear Case Disassembly - P10 Digital assembly board, SpO connector, SpO module, Rear cover ..34 Figure 16.

  • Page 5: Safety Information

    This section contains important safety information related to general use of the P10 hand-helded pulse oximeter. Other important safety information appears throughout the manual. The P10 may be referred to as the pulse oximeter throughout this manual. Important! Before use, carefully read this manual, the Instruction Manual, accessory directions for use, and all precautionary information and specifications.

  • Page 6: Cautions

    Manual Overview This manual contains information for servicing the P10 pulse oximeter. The pulse oximter is subsequently referred to as the pulse oximeter throughout this manual. Only qualified service personnel should service this product. Before servicing the pulse oximeter, read the operation manual carefully for a thorough understanding of safe operation.

  • Page 7: Intended Use For The P10 Pulse Oximeter

    Intended Use for the P10 pulse oximeter The P10 pulse oximeter is intended to be used to monitor functional arterial oxygen saturation (SpO ) and pulse rate in all areas of a hospital, hospital-type facilities, intra- hospital transport and home environments. Users should be skilled at the level of a technician, doctor, nurse or medical specialist.

  • Page 8: Front Panel Components

      Front Panel Components Audible alarm / beep off key alarm indicator (Alarm / Beep inhibition) Pulse rate alarm indicator Menu key Up key Light key Down key Figure 1. Front Panel Components...

  • Page 9: Rear Panel Components

    Rear Panel Components Battery cover Figure 2. Rear Panel Components...

  • Page 10: Right And Left Panel Components

      Right and Left Panel Components Hold key Power on / off key Speaker Figure 3. Right and Left Panel Components...

  • Page 11: Top And Bottom Panel Components

    Top and Bottom Panel Components sensor port Quick guide hanger Data port connector Figure 4. Top and Bottom Panel Components...
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  • Page 13: Routine Maintenance

    (if required by your local institution). The following checks should be performed at least every year by qualified service personnel. 1. Inspect labels for legibility. If the labels are not legible, contact Mediana Technical Service Department. 2. If the pulse oximeter has been visibly damaged or subjected to mechanical shock (for example, if dropped), perform the performance tests as described in the Performance Verification section.

  • Page 14: Batteries

    Batteries CAUTION: Follow local government ordinances and recycling instructions regarding disposal or recycling of device components, including batteries. CAUTION: Do not solder the battery directly. Heat applied during soldering may damage the safety vent in the battery’s positive cover. CAUTION: Do not use the battery with other maker’s batteries, different types or models of batteries such as dry batteries, nickel-metal hydride batteries, or Li-ion batteries together, as they might leak electrolyte heat or explode.

  • Page 15: Performance Verification

    Equipment Description Digital multimeter (DMM) Fluke Model 87 or equivalent sensor (durable) YM-1 simulator Metron SpO Analyzer Daeg with AFP-1 Probe Stopwatch Manual or electronic Note: Contact Mediana Technical Service Department for pricing and ordering information of the required equipment.

  • Page 16: Performance Tests

    Performance Tests All tests may be used following repairs or during routine maintenance (if required by your local institution). This section is written using factory defaults as power-up. Please refer to the Service Menu and Factory Default Settings section to set the factory defaults. If your institution has preconfigured custom defaults, those values will be displayed.

  • Page 17: General Operation Tests

    General Operation Tests Alarms and Alarm Silence 1. Insert the batteries into the pulse oximeter. 2. Press the Power on / off Key to turn on the pulse oximeter. 3. Connect the SpO simulator to the SpO sensor and connect the sensor to the pulse oximter.
  • Page 18 7. Open the sensor and notice that the LED intensity increases. 8. Repeat step 7 and intensity will again decrease. This variation is an indication that the microprocessor is in proper control of LED intensity. 9. Press the Power on / off Key to turn off the pulse oximeter.
  • Page 19 Measurement Parameter Operation Tests Pulse Oximetry Operation 1. Insert the batteries into the pulse oximeter. 1. Turn on the pulse oximeter by pressing the Power on / off Key. 2. Connect the SpO sensor to the SpO connector on the pulse oximeter’s top panel after the pulse oximeter completes POST.

  • Page 20: Verification Check Sheet

    Verification Check Sheet Record the results of the performance verification on this sheet. Model Serial Software Date Tester Name Version ITEMS RESULTS REMARKS PERFORMANCE TEST Power Pass / Fail Power-on self-test (POST) Pass / Fail Date and Time setting Pass / Fail Alarms and alarm silence Pass / Fail Sensor LED test...

  • Page 21: Service Menu And Factory Default

    The purpose of the Service menu is to allow the authorized user to change the all of alarm limit as Factory Default, to create the Current Power-On Alarm Limit Default for the settings in effect each time the P10 is powered on and to set Alarm Reminder Tone to “Off” or “On”.

  • Page 22: Factory Default Reset Menu

    Factory Default Reset Menu When "01" is selected, the Factory Default Reset Menu can be activated. If the “on” is selected in Factory Default Reset Menu, the all of alarm limit in P10 is set as the Factory Default directly. See Table 3.

  • Page 23: Current Limit Saving Menu

    Current Limit Saving Menu When "02" is selected, the Current Limit Saving Menu can be activated. If the “on” is selected in Current Limit Saving Menu, the current limit settings become the Power-On defaults. So the current alarm limit still remains even though the unit is turned off.

  • Page 24: Alarm Remind Tone Menu

    Alarm Remind Tone Menu When "03" is selected, the Alarm Remind Tone Menu can be activated. If the “On” is selected in Alarm Remind Tone Menu, the interval of Alarm Remind Tone is set to 3 minutes and occurs in alarm slience situation. If “Off” is selected, the reminder tone will be disabled.

  • Page 25: Firmware Download

    This section is for the purpose of reloading Firmware into the pulse oximeter 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.
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  • Page 27: Troubleshooting

    TROUBLESHOOTING General This section provides information that can be helpful in troubleshooting the P10 pulse oximeter. 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.

  • Page 28: Troubleshooting Guide

    Problems with the pulse oximeter 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 3. Problem Categories Categories Symptoms 1.
  • Page 29 1. Power Symptom 1.1: Unit will not turn on. Cause or Checkpoint Action Remark Batteries could be missing, Check the batteries. discharged or oriented incorrectly Battery terminal connection error Check the connection between the batteries and the Main board. 2. Display Symptom 2.1: Display is abnormal.

  • Page 30: Table 4. Technical Error Codes

    1. Turn pulse oximeter off, then on again. Note: If error code still appears, take pulse oximeter out of service and contact Mediana Technical Service Department or your local representative for advice on remedial action. Table 4. Technical Error Codes...

  • Page 31: Disassembly Guide

    DISASSEMBLY GUIDE WARNING: Performance Verification. Do not place the pulse oximter into operation after repair or maintenance has been performed until all Performance Tests listed in the Performance Verification section of this service manual have been performed. Failure to perform all tests could result in erroneous pulse oximeter readings. CAUTION: Observe ESD (electrostatic discharge) precautions when working within the unit.

  • Page 32: Figure 9. Disassembly Sequence Flow Chart

    Front case assembly Rear case assembly Battery Middle cover LCD window C1-1 Power on / off, hold key Front cover deco P10 Digital assembly board Key pad module Rear cover Figure 9. Disassembly Sequence Flow Chart...

  • Page 33: Replacement Level Supported

    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.

  • Page 34: Pulse Oximeter Disassembly

    Pulse oximeter Disassembly This section describes the steps to separate the front and rear case assemblies. Figure 11. Pulse Oximeter Disassembly Table 5. Part Descriptions - Battery Cover Part Codes Descriptions T0348 Battery cover Before steps B and C 1. Remove the battery cover on the rear case. 2.

  • Page 35: Figure 12. Pulse Oximeter Disassembly

    Figure 12. Pulse Oximeter Disassembly Table 6. Part Descriptions - Front Case and Rear Case Assembly Part Codes Descriptions Front case assembly (B) Rear case assembly (C) Before steps B and C (2) 1. Separate the front case from the rear case.

  • Page 36: Front Case Disassembly (B)

    Front Case Disassembly (B) This section describes the items that may be removed on the front case assembly. Figure 13. Front Case Disassembly - Front cover, Key pad Table 7. Part Descriptions - Front cover, Key pad Part Codes Descriptions T0359 LCD window T0345...

  • Page 37: Rear Case Disassembly (C)

    Rear Case Disassembly (C) This section describes the items that may be removed on the rear case assembly. Figure 14. Rear Case Disassembly - Middle cover Table 8. Part Descriptions - Handle, Alarm LED Board, Alarm Window, Inner Case Part Codes Descriptions T0346 Middle cover...

  • Page 38: Figure 15. Rear Case Disassembly - P10 Digital Assembly Board, Spo

    Figure 15. Rear Case Disassembly - P10 Digital assembly board, SpO connector, SpO module, Rear cover Table 9. Part Descriptions - P10 Digital assembly board, SpO connector, SpO module, Rear cover Part Codes Descriptions P1131 P10 digital assembly board W031...

  • Page 39: Figure 16. P10 Exploded View

    Figure 16. P10 Exploded View...
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  • Page 41: Spare Parts

    Spare parts, along with part numbers, are shown in Table 10. “Item No.” corresponds to the circled callout numbers in Figure 17. Obtaining Replacement Parts Mediana provides technical assistance information and replacement parts. To obtain replacement parts, contact Mediana Technical Service Department. Refer to parts by the part names and part numbers.

  • Page 42: Figure 17. P10 Exploded View - Spare Parts

    Figure 17. P10 Exploded View - Spare Parts...

  • Page 43: Table 10. Spare Part List

    Connector cover (24pin) T0344 Front cover T0349 Key pad T0355 Power on / off key T0356 Hold key T0346 Middle cover P1131 P10 digital assembly board W0231 connector P1132 assembly board T4187 Battery terminal dual T0347 Rear cover M6033 Battery T0348...
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  • Page 45: Packing For Shipment

    Pack the pulse oximeter 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 P10 Instruction Manual. If the original shipping carton is not available, use another suitable carton.
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  • Page 47: Specification

    SPECIFICATION Display Screen Size 38.2 mm x 44.3 mm Screen Type 3 digit LCD FSTN, Positive mode Controls 6 soft keys (Power, Menu, Up, Down, Audible alarm / beep Standard off, Back light), hold key Alarms Categories Patient Status and System Status Priorities Low and High Priorities Notification...

  • Page 48: Electrical

    Electrical Battery Three new batteries typically provide 30 hours of monitoring with no external communication, no audible alarm sound and 25°C Type Alkaline (AAA batteries) Voltage/Capacity 1.5 V x 3 Environmental Conditions Operation Temperature 5 to 40°C (41 to 104°F) Humidity 15 to 90% RH, non-condensing Altitude...

  • Page 49: Tone Definition

    Tone Definition High Priority Alarm Tone Volume level Not changeable Pitch (± 5%) 976 Hz Pulse width (± 5%) 200 msec (IEC60601-1-8) Number of pulses 10 pulses per 4 sec, 10 sec inter burst Repetitions Continually Low Priority Alarm Tone Volume level Not changeable Pitch (±...

  • Page 50: Measurement Parameters

    Measurement Parameters Pulse Rate Range 30 to 300 BPM Accuracy Whichever is greater 2 BPM or ±2 BPM Range 0 to 100 % Accuracy Without interference 70% to 100% ±2 % Within 1 seconds Defibrillator discharge recovery Defibrillator Protection Protected Note: The wavelength range of the light emitted are 660nm with the energy not exceeding 2mW and 905nm with the energy not exceeding 2~2.4mW.

  • Page 51: Compliance

    Compliance Item Standard Compliant with Classification IEC60601-1:1988 Internally powered (on battery power) +A1:1991+A2:1995 EN60601-1:1990 +A1:1993 +A2:1995 Type of IEC60601-1:1988 Type BF – Applied part protection +A1:1991+A2:1995 EN60601-1:1990 +A1:1993 +A2:1995 Mode of IEC60601-1:1988 User selectable operation +A1:1991+A2:1995 -Continuous monitoring (default) EN60601-1:1990 -Spot check mode +A1:1993 +A2:1995 (Refer to Using the Spot Check Mode section)
  • Page 52 Item Standard Compliant with ISO10993-1:2009/ Biological evaluation of medical devices – Part Cor1:2010, 1: Evaluation and testing EN ISO10993- 1:2009/ AC:2010 ISO10993-5:2009 Biological evaluation of medical devices – Part EN ISO10993-5:2009 5: Tests for in vitro cytotoxicity ISO10993-10: 2010 Biological evaluation of medical devices – Part EN ISO10993- 10: Tests for irritation and delayed-type 10:2013...
  • Page 53 Item Standard Compliant with IEC60068-2-6:2007 Environmental testing - vibration (sinusoidal) EN60068-2-6:2008 IEC60068-2-64:2008 Environmental testing - vibration, broad-band EN60068-2-64:2008 random (digital control) and guidance IEC60068-2-27:2008 Environmental testing - Shock EN60068-2-27:2009 Labeling EN1041:2008 Information supplied by the manufacturer with medical devices Marking IEC/TR60878:2003 Graphical symbols for electrical equipment in medical practice...
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  • Page 55: System Processing

    SYSTEM PROCESSING System Overview The P10 pulse oximeter is hand-held pulse oximeter for use on adult patients; arterial oxygen saturation and pulse rate. In addition to monitoring and displaying the status of these physiological parameters, the instrument performs various microprocessor-programmed analytical functions;...

  • Page 56: Figure 19. Process Unit Block Diagram

    Unit Description  Processor unit: consists of PIC18F65J90 CPU. LCD Controller UART LCD Display SpO2 Module Port Input UART Buttons Serial I/O Main Control Unit Sound Module (PIC18F65J90) Serial EEPROM Port Output Alarm and Key Real Time Clock Display and User Indicator Unit Communication Unit Figure 19.

  • Page 57: Figure 22. Spo 2 Unit Block Diagram

     unit: measures oxygen saturation data. Power from Power Unit SpO2 Module (ChipO2) Figure 22. SpO Unit Block Diagram...

  • Page 58: Spo Processing

    Processing Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photodetector. Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases.

  • Page 59: Figure 23. Oxyhemoglobin Dissociation Curve

    Temperature PCO2 2,3-DPG Fetal Hb Temperature 2,3-DPG (mmHg) Figure 23. Oxyhemoglobin Dissociation Curve Functional versus Fractional Saturation This pulse oximeter measures functional saturation — oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. It does not detect significant amounts of dysfunctional hemoglobin, such as carboxyhemoglobin or methemoglobin.

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