Mediana M20 Manuel utilisateur

SERVICE MANUAL

Patient Monitor M20

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

Revised Date: 2015-08

Part Number: A7114-6

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 M20. 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 M20 conforms to the EMC standard IEC60601-1-2.

Note that mobile phones should not be used in the vicinity of the M20.

Note, however, any device not complying to the EMC standard that is used with the M20 renders

the M20 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.

CONTENTS

CONTENTS....................................................................................................................................................i

SAFETY INFORMATION ..............................................................................................................................1

General Safety Information ...................................................................................................................1

Warnings................................................................................................................................................1

Cautions ................................................................................................................................................2

Manual Overview...................................................................................................................................2

Related Documents...............................................................................................................................2

Intended Use for the M20 Monitor.........................................................................................................3

Indications For Use................................................................................................................................3

Identifying the M20 Monitor Configurations...........................................................................................4

Front Panel Components ......................................................................................................................5

Rear Panel Components.......................................................................................................................6

Left Panel Components.........................................................................................................................7

Right Panel Components ......................................................................................................................8

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......................................................................................................................14

Safety Tests.........................................................................................................................................26

Verification Check Sheet .....................................................................................................................30

SERVICE MENU AND FACTORY DEFAULT.............................................................................................33

General................................................................................................................................................33

Service Menu.......................................................................................................................................33

Done....................................................................................................................................................37

Factory Default Settings......................................................................................................................38

FIRMWARE DOWNLOAD ..........................................................................................................................41

General................................................................................................................................................41

Equipment Needed..............................................................................................................................41

How to Download ................................................................................................................................41

TROUBLESHOOTING................................................................................................................................45

General................................................................................................................................................45

How to Use This Section.....................................................................................................................45

Who Should Perform Repairs..............................................................................................................45

Replacement Level Supported............................................................................................................45

Troubleshooting Guide ........................................................................................................................46

DISASSEMBLY GUIDE ..............................................................................................................................53

General................................................................................................................................................53

Replacement Level Supported............................................................................................................55

Prior to Disassembly............................................................................................................................55

Fuse Replacement ..............................................................................................................................55

Battery Replacement (A1)...................................................................................................................55

Optional Printer Disassembly (A2) ......................................................................................................56

Monitor Disassembly...........................................................................................................................58

Front Case Disassembly (B) ...............................................................................................................60

Rear Case Disassembly (C)................................................................................................................62

SPARE PARTS ...........................................................................................................................................71

General................................................................................................................................................71

Obtaining Replacement Parts .............................................................................................................71

PACKING FOR SHIPMENT........................................................................................................................75

General Instructions ............................................................................................................................75

Returning the M20 Monitor..................................................................................................................75

Repacking in Original Carton ..............................................................................................................75

Repacking in a Different Carton ..........................................................................................................75

SPECIFICATION.........................................................................................................................................77

Display.................................................................................................................................................77

Controls ...............................................................................................................................................77

Alarms .................................................................................................................................................77

Physical Characteristics and Printer....................................................................................................77

Electrical..............................................................................................................................................79

Environmental Conditions ...................................................................................................................79

Tone Definition.....................................................................................................................................80

Measurement Parameters...................................................................................................................81

Trends..................................................................................................................................................86

Compliance..........................................................................................................................................87

SYSTEM PROCESSING.............................................................................................................................91

System Overview.................................................................................................................................91

System Block Diagram........................................................................................................................91

ECG Processing..................................................................................................................................97

NIBP Processing .................................................................................................................................97

SpO2Processing .................................................................................................................................99

Respiration Processing .....................................................................................................................101

Temperature Processing ...................................................................................................................102

iii

Figures

Figure 1. Front Panel Components................................................................................................................................5

Figure 2. Rear Panel Components ................................................................................................................................6

Figure 3. Left Panel Components..................................................................................................................................7

Figure 4. Right Panel Components................................................................................................................................8

Figure 5. Pressure Sensor Accuracy Test....................................................................................................................20

Figure 6. Air Leakage Test...........................................................................................................................................21

Figure 7. Inflation Time Measurement .........................................................................................................................21

Figure 8. Deflation Rate Measurement........................................................................................................................22

Figure 9. The access of Service Menu via Set-up menu .............................................................................................33

Figure 10. The access of Service Menu via Set-up menu ...........................................................................................34

Figure 11. Service Menu..............................................................................................................................................34

Figure 12. Firmware Downloading Display..................................................................................................................41

Figure 13. Firmware Downloading Completion............................................................................................................42

Figure 14. Disassembly Sequence Flow Chart............................................................................................................54

Figure 15. Battery Replacement..................................................................................................................................55

Figure 16. Printer Disassembly....................................................................................................................................56

Figure 17. Printer Disassembly - Printer Board, Printer Body Case, Printer Opener Case, Printer Door Case, Printer

Mecha, Printer Door Pin, Printer Paper .......................................................................................................................56

Figure 18. Monitor Disassembly ..................................................................................................................................58

Figure 19. Monitor Disassembly ..................................................................................................................................59

Figure 20. Front Case Disassembly - Front Case, LCD, Key Board............................................................................60

Figure 21. Rear Case Disassembly - Handle, Alarm LED Board, Alarm Window, Inner Case.....................................62

Figure 22. Rear Case Disassembly - Main Board, Side Connector Cover, ECG Connector........................................64

Figure 23. Rear Case Disassembly - ECG & Respiration Module, SpO2Module, CPU Module (For Nellcor SpO2

Module)........................................................................................................................................................................65

Figure 24. Rear Case Disassembly - ECG & Respiration Module, SpO2Module, CPU Module (For Mediana SpO2

Module)........................................................................................................................................................................65

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

Board, NIBP Module....................................................................................................................................................67

Figure 26. M20 Exploded View....................................................................................................................................69

Figure 27. M20 Exploded View - Spare Parts..............................................................................................................72

Figure 28. System Block Diagram ...............................................................................................................................91

Figure 29. Power Unit Block Diagram..........................................................................................................................92

Figure 30. Process Unit Block Diagram.......................................................................................................................92

Figure 31. User-Control Unit Block Diagram................................................................................................................93

Figure 32. Sound Unit Block Diagram..........................................................................................................................93

Figure 33. Communication Unit Block Diagram...........................................................................................................93

Figure 34. GUI Unit Block Diagram..............................................................................................................................94

Figure 35. Thermal Printer Unit Block Diagram ...........................................................................................................94

Figure 36. NIBP Unit Block Diagram............................................................................................................................94

Figure 37. ECG Unit Block Diagram............................................................................................................................95

Figure 38. Respiration Unit Block Diagram..................................................................................................................95

Figure 39. SpO2Unit Block Diagram ...........................................................................................................................95

Figure 40. Temperature Unit Block Diagram................................................................................................................96

Figure 41. Oxyhemoglobin Dissociation Curve..........................................................................................................100

Tables

Table 1. Required Equipment ...................................................................................................................................... 11

Table 2. Parameter Alarm Limit Factory Defaults.........................................................................................................15

Table 3. Earth Leakage Current Values.......................................................................................................................26

Table 4. Enclosure Leakage Current ...........................................................................................................................27

Table 5. Patient Leakage Current Values ....................................................................................................................27

Table 6. Patient Leakage Current Values - Mains Voltage onApplied Part .................................................................28

Table 7. Test Lead Combinations.................................................................................................................................29

Table 8. Allowable Leakage Current............................................................................................................................29

Table 9. Service Menu.................................................................................................................................................35

Table 10. NIBP Test.....................................................................................................................................................37

Table 11. System Information ......................................................................................................................................37

Table 12. Factory Default Settings...............................................................................................................................38

Table 13. Required Equipment for Firmware Download...............................................................................................41

Table 14. Completion Codes........................................................................................................................................42

Table 15. Problem Categories .....................................................................................................................................46

Table 16. Firmware Downloading Error Codes............................................................................................................51

Table 17. Technical Error Codes..................................................................................................................................51

Table 18. Part Descriptions - Printer Board, Printer Body Case, Printer Opener Case, Printer Door Case, Printer

Mecha, Printer Door Pin, Printer Paper .......................................................................................................................57

Table 19. Part Descriptions - Printer Cover..................................................................................................................58

Table 20. Part Descriptions - Front Case and Rear Case Assembly............................................................................59

Table 21. Part Descriptions - Front Case, LCD, Key Board.........................................................................................60

Table 22. Part Descriptions - Handle, Alarm LED Board, Alarm Window, Inner Case..................................................62

Table 23. Part Descriptions - Main Board, Side Connector Cover, ECG Connector....................................................64

Table 24. Part Descriptions - ECG & Respiration Module, SpO2Module, CPU Module ..............................................65

Table 25. Part Descriptions - SMPS, AC Inlet, Speaker, ECG Arrester Board, Printer Interface Board, TCP/IP Board,

NIBP Module................................................................................................................................................................67

Table 26. Spare Part List .............................................................................................................................................73

SAFETY INFORMATION

General Safety Information

This section contains important safety information related to general use of the M20

monitor. Other important safety information appears throughout the manual. The M20 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.

Warnings alert you to potential serious outcomes (death, injury, or adverse events)

to the patient or user.

WARNING: Explosion hazard. Do not use the monitor in the presence of flammable

anesthetics or gases.

WARNING: Do not spray, pour, or spill any liquid on the monitor, its accessories,

connectors, switches, or openings in the chassis.

WARNING: Do not immerse the monitor or its accessories in liquid or clean with

caustic or abrasive cleaners.

WARNING: Ensure that conductive portions of the electrodes, leads, and cable do

not come into contact with any other conductive parts.

WARNING: Before attempting to open or disassemble the monitor, disconnect the

power cord from the monitor.

WARNING: Chemicals from a broken LCD display panel are toxic when ingested.

Use caution when handling a monitor with a broken display panel.

WARNING: The use of accessories, transducers, and cables other than those

specified may result in increased emission and/or decreased immunity of the

monitor.

WARNING: Do not Audio off the monitor Alarm audio or decrease its volume if

patient safety could be compromised.

WARNING: During the safety test, AC power voltage will be present on the applied

part terminals. Exercise caution to avoid electrical shock hazard.

WARNING: 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: High voltage is generated by the LCD backlight driver. Exercise caution

when operating the monitor with covers open.

WARNING: Extreme care must be taken in modifying default or other settings to

ensure they are appropriate to the intended use.

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.

CAUTION: If there is a problem with the optional printer, check to make sure the

printer door is closed properly.

CAUTION: If the internal battery cable has been disconnected, pay particular

attention to polarity of the cable before reattaching. If the battery cable polarity is

reversed, it is likely that circuit damage will occur.

CAUTION: Ferrite Cores are used for electromagnetic compatibility. Please do not

remove Ferrite Cores while disassembling or reassembling, otherwise the monitor

can be affected by electromagnetic interference and cause inaccurate data to be

displayed or stored.

CAUTION: For continued protection against risk of fire, replace the fuse only with the

same type and rating of fuse.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

Manual Overview

This manual contains information for servicing the M20 monitor.

The monitor is subsequently referred to as the monitor throughout this manual. Only

qualified service personnel should service this product. Before servicing the monitor, 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.

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