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Mediana P10 Service Manual

Other manuals for P10: Operator's Manual

Summary of P10

  • Page 1

    Service manual pulse oximeter p10 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-...

  • Page 2

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

  • Page 3: Contents

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

  • Page 4

    Ii figures figure 1. Front panel components ................................................................................................................................ 4 figure 2. Rear panel components ................................................................................................

  • Page 5: Safety Information

    1 safety information general 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. ...

  • Page 6

    2 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 ...

  • Page 7

    3 intended use for the p10 pulse oximeter the p10 pulse oximeter is intended to be used to monitor functional arterial oxygen saturation (spo 2 ) 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...

  • Page 8

    4 front panel components 1 lcd 5 audible alarm / beep off key 2 spo 2 alarm indicator (alarm / beep inhibition) 3 pulse rate alarm indicator 6 menu key 4 up key 7 light key 8 down key figure 1. Front panel components 1 2 3 4 5 6 7 8.

  • Page 9

    5 rear panel components figure 2. Rear panel components 1 battery cover 1.

  • Page 10

    6 right and left panel components 1 hold key 2 power on / off key 3 speaker figure 3. Right and left panel components 1 2 3.

  • Page 11

    7 top and bottom panel components 1 spo 2 sensor port 2 quick guide hanger 3 data port connector figure 4. Top and bottom panel components 1 2 3.

  • Page 12

    8 this page is intentionally left blank..

  • Page 13: Routine Maintenance

    9 routine maintenance warning: do not spray or pour any liquid on the pulse oximeter or its accessories. Do not immerse the pulse oximeter or its accessories in liquid or clean with caustic or abrasive cleaners. Cleaning the pulse oximeter may be surface-cleaned by using a soft cloth dampened with e...

  • Page 14

    10 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. Cautio...

  • Page 15: Performance Verification

    11 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 pulse oximeter covers. If the pulse oximeter fails to perform as specified in any test, repairs must be mad...

  • Page 16

    12 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 i...

  • Page 17

    13 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 2 simulator to the spo 2 sensor and connect the sensor to the pulse oximter. 4. Set the spo 2 simulator as follows: s...

  • Page 18

    14 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

    15 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 2 sensor to the spo 2 connector on the pulse oximeter’s top panel after the pulse oximeter complete...

  • Page 20

    16 verification check sheet record the results of the performance verification on this sheet. Model name serial no. Software version date tester items results remarks performance test power pass / fail power-on self-test (post) pass / fail date and time setting pass / fail alarms and alarm silence p...

  • Page 21

    17 service menu and factory default general this section discusses use of the service menu to configure ‘factory default rest menu’, ‘current limit saving menu’ and ‘alarm remind tone menu’ service menu the purpose of the service menu is to allow the authorized user to change the all of alarm limit ...

  • Page 22

    18 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. Figure 6. Factory default reset on/off display note: if fact...

  • Page 23

    19 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. Figure 7. Cu...

  • Page 24

    20 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. Figu...

  • Page 25: Firmware Download

    21 firmware download general 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...

  • Page 26

    22 this page is intentionally left blank..

  • Page 27: Troubleshooting

    23 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...

  • Page 28

    24 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 resolve...

  • Page 29

    25 1. Power symptom 1.1: unit will not turn on. Cause or checkpoint action remark batteries could be missing, discharged or oriented incorrectly check the batteries. Battery terminal connection error check the connection between the batteries and the main board. 2. Display symptom 2.1: display is ab...

  • Page 30

    26 5. Technical alarm condition when the pulse oximeter detects an error condition, the pulse oximeter will attempt to show an error code on the display screen. If such an error occurs during monitoring operation, the pulse oximeter will sound a high or low-priority alarm. Audible alarm can be termi...

  • Page 31: Disassembly Guide

    27 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 cou...

  • Page 32

    28 p10 front case assembly rear case assembly b c a battery b1 b2 c1 c2 key pad b3 front cover deco c3 a1 p10 digital assembly board power on / off, hold key middle cover c1-1 lcd window spo 2 module rear cover c4 figure 9. Disassembly sequence flow chart.

  • Page 33

    29 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 sympto...

  • Page 34

    30 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 qty t0348 battery cover 1 before steps b and c 1. Remove the battery cover on the re...

  • Page 35

    31 figure 12. Pulse oximeter disassembly table 6. Part descriptions - front case and rear case assembly part codes descriptions qty - front case assembly (b) 1 - rear case assembly (c) 1 before steps b and c (2) 1. Separate the front case from the rear case..

  • Page 36

    32 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 qty t0359 lcd window 1 t0345 front cover deco 1 t0357 led ...

  • Page 37

    33 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 qty t0346 middle cover 1 t0355 power on ...

  • Page 38

    34 figure 15. Rear case disassembly - p10 digital assembly board, spo 2 connector, spo 2 module, rear cover table 9. Part descriptions - p10 digital assembly board, spo 2 connector, spo 2 module, rear cover part codes descriptions qty p1131 p10 digital assembly board 1 w031 spo 2 connector 1 p1132 s...

  • Page 39

    35 figure 16. P10 exploded view.

  • Page 40

    36 this page is intentionally left blank..

  • Page 41: Spare Parts

    37 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 10. “item no.” corresponds to the circled callout numbers in figure 17. Obta...

  • Page 42

    38 figure 17. P10 exploded view - spare parts.

  • Page 43

    39 table 10. Spare part list item part code description 1 t0359 lcd window 2 t0345 front cover deco 3 t0357 led window 4 t0358 connector cover (24pin) 5 t0344 front cover 6 t0349 key pad 7 t0355 power on / off key 8 t0356 hold key 9 t0346 middle cover 10 p1131 p10 digital assembly board 11 w0231 spo...

  • Page 44

    40 this page is intentionally left blank..

  • Page 45: Packing For Shipment

    41 packing for shipment general instructions to ship the pulse oximeter for any reason, follow the instructions in this section. 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...

  • Page 46

    42 this page is intentionally left blank..

  • Page 47: Specification

    43 specification display screen size 38.2 mm x 44.3 mm screen type 3 digit lcd fstn, positive mode controls standard 6 soft keys (power, menu, up, down, audible alarm / beep off, back light), hold key alarms categories patient status and system status priorities low and high priorities notification ...

  • Page 48

    44 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, no...

  • Page 49

    45 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 (± 5%) 488 hz pulse width ...

  • Page 50

    46 measurement parameters spo 2 pulse rate range 30 to 300 bpm accuracy whichever is greater 2 bpm or ±2 bpm spo 2 range 0 to 100 % accuracy without interference 70% to 100% ±2 % defibrillator discharge recovery within 1 seconds defibrillator protection protected note: the wavelength range of the li...

  • Page 51

    47 compliance item standard compliant with classification iec60601-1:1988 +a1:1991+a2:1995 en60601-1:1990 +a1:1993 +a2:1995 internally powered (on battery power) type of protection iec60601-1:1988 +a1:1991+a2:1995 en60601-1:1990 +a1:1993 +a2:1995 type bf – applied part mode of operation iec60601-1:1...

  • Page 52

    48 item standard compliant with iso10993-1:2009/ cor1:2010, en iso10993- 1:2009/ ac:2010 biological evaluation of medical devices – part 1: evaluation and testing iso10993-5:2009 en iso10993-5:2009 biological evaluation of medical devices – part 5: tests for in vitro cytotoxicity iso10993-10: 2010 e...

  • Page 53

    49 item standard compliant with iec60068-2-6:2007 en60068-2-6:2008 environmental testing - vibration (sinusoidal) iec60068-2-64:2008 en60068-2-64:2008 environmental testing - vibration, broad-band random (digital control) and guidance iec60068-2-27:2008 en60068-2-27:2009 environmental testing - shoc...

  • Page 54

    50 this page is intentionally left blank..

  • Page 55: System Processing

    51 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-programm...

  • Page 56

    52 unit description processor unit: consists of pic18f65j90 cpu. Real time clock main control unit (pic18f65j90) display and user indicator unit communication unit serial eeprom serial i/o spo2 module lcd display buttons sound module alarm and key led uart i2c i2c uart lcd controller port output pwm...

  • Page 57

    53 spo 2 unit: measures oxygen saturation data. Spo2 module (chipo2) mcu uart 2 power from power unit figure 22. Spo 2 unit block diagram.

  • Page 58

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

  • Page 59

    55 100 50 0 50 100 satu ratio n (% ) po 2 (mmhg) ph temperature pco2 2,3-dpg fetal hb ph temperature pco 2 2,3-dpg figure 23. Oxyhemoglobin dissociation curve functional versus fractional saturation this pulse oximeter measures functional saturation — oxygenated hemoglobin expressed as a percentage ...