Mediana P10 User manual

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: [phone] (82) 33 742 5400
Fax:[phone] (82) 33 742 5483
Part Number: A7137-4
Revised Date: 0414
Copyright © 2014 All rights reserved.

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 contact our service center.
The manual will be replaced if any pages are missing or collation is incorrect.
Warranty
Please contact your local distributor about the warranty period.
Device failure or damage related to the following situations during the guarantee period
is not covered by this warranty:
Installation, transfer installation, maintenance and repairs by any person other than
an authorized Mediana. employee or technician specified by Mediana.
Damage sustained to the Mediana product(s) caused by product(s) from another
company excluding products delivered by Mediana.
Damage – caused by mishandling and/or misuse – is the responsibility of the user.
Maintenance and repairs utilizing maintenance components that are not specified
by Mediana.
Device modifications or use of accessories not recommended by Mediana.
Damage caused by accidents or natural disasters (earthquakes, flooding, etc.).
Damage resulting from usage where caution statements and operating instructions
shown in this manual have not been followed.
Damage due to neglect of specified maintenance checks.
This warranty only covers the hardware of the P10. The warranty does not cover the
following selections:
Whatever damage or loss results from the attachment of accessories or their
operation.
In the event of a defect in the product, contact our sales outlet or EU representative
as noted on the back cover.
The P10 conforms to the EMC standard IEC60601-1-2.
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.
Trademark
Product brand names shown in this manual are likely to be the trademark or registered
trademark of the company concerned.

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CONTENTS
CONTENTS....................................................................................................................................................i
SAFETY INFORMATION..............................................................................................................................1
General Safety Information ...................................................................................................................1
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......................................................................................................7
ROUTINE MAINTENANCE...........................................................................................................................9
Cleaning ................................................................................................................................................9
Periodic Safety and Functional Checks.................................................................................................9
Batteries ..............................................................................................................................................10
Environmental Protection ....................................................................................................................10
PERFORMANCE VERIFICATION..............................................................................................................11
General................................................................................................................................................ 11
Required Equipment............................................................................................................................ 11
Performance Tests...............................................................................................................................12
General Operation Tests......................................................................................................................13
Verification Check Sheet .....................................................................................................................16
SERVICE MENU AND FACTORY DEFAULT.............................................................................................17
General................................................................................................................................................17
Service Menu.......................................................................................................................................17
Factory Default Reset Menu................................................................................................................18
Current Limit Saving Menu..................................................................................................................19
Alarm Remind Tone Menu ...................................................................................................................20
FIRMWARE DOWNLOAD ..........................................................................................................................21
General................................................................................................................................................21
TROUBLESHOOTING................................................................................................................................23
General................................................................................................................................................23
How to Use This Section .....................................................................................................................23
Who Should Perform Repairs..............................................................................................................23
Replacement Level Supported ............................................................................................................23
Troubleshooting Guide ........................................................................................................................24
DISASSEMBLY GUIDE ..............................................................................................................................27
General................................................................................................................................................27
Replacement Level Supported ............................................................................................................29
Battery Replacement (A1) ...................................................................................................................29
Pulse oximeter Disassembly ...............................................................................................................30
Front Case Disassembly (B) ...............................................................................................................32
Rear Case Disassembly (C)................................................................................................................33
SPARE PARTS ...........................................................................................................................................37
General................................................................................................................................................37
Obtaining Replacement Parts..............................................................................................................37
PACKING FOR SHIPMENT........................................................................................................................41
General Instructions ............................................................................................................................41
Returning the P10 Pulse oximeter.......................................................................................................41
Repacking in Original Carton ..............................................................................................................41
Repacking in a Different Carton ..........................................................................................................41
SPECIFICATION.........................................................................................................................................43
Display.................................................................................................................................................43
Controls ...............................................................................................................................................43
Alarms .................................................................................................................................................43
Physical Characteristics ......................................................................................................................43
Electrical ..............................................................................................................................................44
Environmental Conditions ...................................................................................................................44
Tone Definition.....................................................................................................................................45
Measurement Parameters...................................................................................................................46
Trends..................................................................................................................................................46
Compliance..........................................................................................................................................47
SYSTEM PROCESSING.............................................................................................................................51
System Overview.................................................................................................................................51
System Block Diagram ........................................................................................................................51
SpO2Processing .................................................................................................................................54

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Figures
Figure 1. Front Panel Components................................................................................................................................4
Figure 2. Rear Panel Components ................................................................................................................................5
Figure 3. Right and Left Panel Components..................................................................................................................6
Figure 4. Top and Bottom Panel Components...............................................................................................................7
Figure 5. Service Menu Display...................................................................................................................................17
Figure 6. Factory Default Reset On/Off Display...........................................................................................................18
Figure 7. Current Limit Saving On/Off Menu Display...................................................................................................19
Figure 8. Alarm Remind Tone On/Off Menu Display....................................................................................................20
Figure 9. Disassembly Sequence Flow Chart..............................................................................................................28
Figure 10. Battery Replacement..................................................................................................................................29
Figure 11. Pulse Oximeter Disassembly......................................................................................................................30
Figure 12. Pulse Oximeter Disassembly......................................................................................................................31
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, SpO2connector, SpO2module, Rear cover.........34
Figure 16. P10 Exploded View.....................................................................................................................................35
Figure 17. P10 Exploded View - Spare Parts...............................................................................................................38
Figure 18. System Block Diagram ...............................................................................................................................51
Figure 19. Process Unit Block Diagram.......................................................................................................................52
Figure 20. Sound Unit Block Diagram..........................................................................................................................52
Figure 21. Display Unit Block Diagram........................................................................................................................52
Figure 22. SpO2Unit Block Diagram ...........................................................................................................................53
Figure 23. Oxyhemoglobin Dissociation Curve............................................................................................................55
Tables
Table 1. Required Equipment ...................................................................................................................................... 11
Table 2. Factory Default Settings.................................................................................................................................18
Table 3. Problem Categories .......................................................................................................................................24
Table 4. Technical Error Codes....................................................................................................................................26
Table 5. Part Descriptions - Battery Cover...................................................................................................................30
Table 6. Part Descriptions - Front Case and Rear Case Assembly..............................................................................31
Table 7. Part Descriptions - Front cover, Key pad........................................................................................................32
Table 8. Part Descriptions - Handle, Alarm LED Board, Alarm Window, Inner Case....................................................33
Table 9. Part Descriptions - P10 Digital assembly board, SpO2connector, SpO2module, Rear cover........................34
Table 10. Spare Part List .............................................................................................................................................39

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.
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.
Warnings alert you to potential serious outcomes (death, injury, or adverse events)
to the patient or user.
WARNING: Explosion hazard. Do not use the pulse oximeter in the presence of
flammable anesthetics or gases.
WARNING: Do not spray, pour, or spill any liquid on the pulse oximeter, its
accessories, connectors, switches, or openings in the chassis.
WARNING: Do not immerse the pulse oximeter or its accessories in liquid or clean
with caustic or abrasive cleaners.
WARNING: Chemicals from a broken LCD display panel are toxic when ingested.
Use caution when handling a pulse oximeter with a broken display panel.
WARNING: Do not place the pulse oximeter 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.
WARNING: Extreme care must be taken in modifying default or other settings to
ensure they are appropriate to the intended use.

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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 pulse oximeter and when
handling any of the components of the pulse oximeter.
CAUTION: When reassembling the pulse oximeter, over-tightening screws could
strip the screw holes in the cases, rendering it unusable.
CAUTION: If the battery has been disconnected, pay particular attention to polarity
of the battery before reattaching. If the battery polarity is reversed, it is likely that
circuit damage will occur.
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.
Read and understand all safety warnings and service notes printed in this service manual
and the operation manual.
Related Documents
To perform tests and troubleshooting procedures, and to understand the principles of
operation and circuit analysis sections of this manual, you must know how to operate the
pulse oximeter. Refer to the pulse oximeter operation manual.
To understand the various SpO2sensors that work with the pulse oximeter, refer to the
individual directions for use that accompany these accessories.

3
Intended Use for the P10 pulse oximeter
The P10 pulse oximeter is intended to be used to monitor functional arterial oxygen
saturation (SpO2) 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.
Note: The continuous monitoring and Spot check mode are user-selectable. The mode of
operation is the continuous monitoring except when the Spot Check Mode (03) is
enabled.

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4
Front Panel Components
1 LCD 5 Audible alarm / beep off key
2 SpO2alarm 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

5
Rear Panel Components
Figure 2. Rear Panel Components
1 Battery cover
1

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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

7
Top and Bottom Panel Components
1 SpO2sensor port
2 Quick guide hanger
3 Data port connector
Figure 4. Top and Bottom Panel Components
1
2
3

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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 either a
commercial, nonabrasive cleaner or one of the solutions listed below. Lightly wipe the
top, bottom and front surfaces of the pulse oximeter.
Quatemary Ammonium
70% Isopropyl alcohol
10% Chlorine bleach solution
PDI Sani-System
For sensors, follow cleaning instructions in the directions for use shipped with those
components.
Avoid spilling liquid on the pulse oximeter, especially in connector areas. If liquid is
accidentally spilled on the pulse oximeter, clean and dry thoroughly before reuse. If in
doubt about pulse oximeter safety, refer the unit to qualified service personnel for
checking.
Periodic Safety and Functional Checks
The following performance verification tests may be used following repair or during 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. If the unit fails these performance tests, refer to the
Troubleshooting section.

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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.
CAUTION: Keep the battery out of reach of babies and children to avoid any
accidents.
Note: The battery should be removed from the unit if placed in storage or will not be used
for a long period.
Environmental Protection
Follow local governing ordinances and recycling plans regarding disposal or recycling of
batteries and other device components.
Note: The pulse oximeter should be disposed of separately from the municipal waste
stream via designated collection facilities appointed by the government or the local
authorities.
Note: The correct disposal of your old appliance will help prevent potential negative
consequences for the environment and human health.
Note: For more detailed information about disposal of your old appliance, please contact
your city office, waste disposal service or the shop where you purchased the pulse
oximeter.

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 made to
correct the problem before the pulse oximeter is returned to the user.
Required Equipment
Table 1 lists the equipment required for performance verifications.
Table 1. Required Equipment
Equipment Description
Digital multimeter (DMM) Fluke Model 87 or equivalent
SpO2sensor (durable) YM-1
SpO2simulator Metron SpO2 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.

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 institution has preconfigured custom defaults, those values will be displayed.
Power
1. Insert the batteries into the pulse oximeter.
2. Press the Power on / off Key on the right of the pulse oximeter.
3. Verify that the pulse oximeter is turned on.
4. Press the Power on / off Key over 2 seconds, and then verify that the pulse oximeter
is turned off.
Power-On Self-Test (POST)
1. Insert the batteries into the pulse oxitmeter.
2. Observe the pulse oximeter’s LCD screen. With the pulse oximeter off, press the
Power on / off Key. The pulse oximeter must perform the following sequence:
a. The pulse oximeter performs the power-on self-test (POST) and displays all
segments in the LCD while the checksum is proceeding.
b. During the POST, the alarm indicators are lit for a few seconds. The LCD
displays the version of system.
c. Upon successful completion of the POST, the POST pass tone sounds and the
pulse oximeter will be in normal monitoring screen.
Note: If an error condition occurs during the POST, the pulse oximeter will display an error
message.
Note: During the POST, the integrity of all programming is checked first. If software testing
is successful, hardware tests are initiated. If all testing is successful, the pulse
oximeter is ready for use. If the POST is failed, please refer to the
Troubleshooting section.
Date and Time Setting
1. Press the Menu key to display the Time Setting Menu (04).
2. Press the Up key or the Down key to increase or decrease the Year or Month then
press the Menu key to set the desired year or month.
3. After setting the Year and Month, Date and Hour can be displayed then the Minute
and Second show up. Also you can adjust Date, Hour, Minute and Second by using
the Up key or the Down key to increase or decrease.
4. After setting the Year, Month, Date, Hour, Minute and Second, End message is
displayed. if you set to “On” changed variables are stored in the memory. Otherwise
changed variables are canceled.
Note: The time format is 24 hours only.

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 SpO2simulator to the SpO2sensor and connect the sensor to the pulse
oximter.
4. Set the SpO2simulator as follows: SpO2of 75% and pulse rate of 60bpm.
5. Verify the following pulse oximter reaction:
a. The pulse amplitude indicator begins to track artificial pulse signal from the
SpO2simulator.
b. After about 10 to 20 seconds, the pulse oximeter displays oxygen saturation
and pulse rate as specified by the simulator. Verify values are within the
following tolerances:
Tolerance of Oxygen Saturation : ±2%
Tolerance of Pulse Rate : ±2bpm
c. Audible alarm sounds and %SpO2alarm indicator on the front panel will flash,
indicating the parameter has violated default alarm limits (high priority alarm).
6. Press the Audible alarm / beep off Key on the front panel. The audible alarm will be
inhibited.
7. Verify the following:
a. The audible alarm remains silenced.
b. The Audible alarm off Icon appears on the LCD.
c. The LED located right side of %SpO2display continues flashing.
d. The audible alarm returns in approximately 3 minutes.
Sensor LED Test
This procedure uses normal system components to test circuit operation. An SpO2sensor,
YM-1 is used to examine LED intensity control. The red LED is used to verify intensity
modulation caused by the LED intensity control circuit.
1. Insert the batteries into the pulse oximeter.
2. Press the Power on / off Key to turn on the pulse oximeter..
3. Connect the SpO2sensor to the pulse oximeter.
4. Leave the sensor open with the LEDs and photodetector visible.
5. After the pulse oximeter completes its normal power-up sequence, verify that the
sensor LED is brightly lit.
6. Slowly move the sensor LED in proximity of the photodetector element of the sensor
(close the sensor slowly). Verify as the LED approaches the optical sensor, the LED
intensity decreases.

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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.

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 SpO2sensor to the SpO2connector on the pulse oximeter’s top panel after
the pulse oximeter completes POST.
3. Connect the SpO2simulator to the SpO2sensor.
4. Test #1: SpO2
a. Press the %SpO2selection button on the SpO2simulator. The %SpO292 LED
will light:
b. The pulse oximeter will display three dashes until the SpO2simulator stabilizes
at 92%SpO2. The test pass criteria is 90 to 94%SpO2.
c. The pulse oximeter will display: - 92%SpO2
-60bpm
-noalarm
5. Test #2: Pulse rate (bpm)
a. Press the PULSE RATE selection button on the SpO2simulator. The PULSE
RATE 240 LED will light.
b. The pulse rate will increase to 240 bpm. The test pass criteria is 238 to 242
bpm.
c. The pulse oximeter will display:
- 92%SpO2
- 240 bpm
- alarm: PR LED will flash, indicating pulse rate is above default high alarm
limit (high priority alarm).
d. Press the PULSE RATE selection button on the SpO2simulator. The PULSE
RATE 60 LED will light.
e. The pulse rate will decrease to 60 and stabilize at 60 bpm. The test pass
criteria is 58 to 62 bpm.
f. The pulse oximeter will display:
- 92%SpO2
- 60 bpm
- no alarm
- low level modulation

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 Pass / Fail
Sensor LED test Pass / Fail
Restoring power-on default settings Pass / Fail
Pulse oximetry operation -
- SpO292 ± 2% Pass/Fail Value: %
- Pulse rate 240 ± 2bpm (High priority alarm condition) Pass / Fail Value: bpm
- Pulse rate 60 ± 2bpm Pass / Fail Value: bpm