Fukuda CardiMax 4 User manual

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Contents
Contents
Preface
Introduction..............................................................................................................................i
About This Manual .................................................................................................................ii
Expression Used in This Manual.........................................................................................................ii
Composition of This Manual................................................................................................................ii
Reminders to Use the Device Safely.....................................................................................iii
Safety Notations.................................................................................................................................iii
An Example of Safety Symbol............................................................................................................iii
Symbols on the Device.......................................................................................................................iii
Safety.................................................................................................................................................iv
Precautions when Using with Other Device ........................................................................................v
System Components (Accessories)...................................................................................................vi
Application to Heart............................................................................................................................vi
Connecting the Power Cable..............................................................................................................vi
Leakage Current................................................................................................................................vii
Precautions for Safe Operation of Medical Electrical Equipment......................................................vii
Precautions for Battery Pack..............................................................................................................ix
Precautions Concerning the LAN.......................................................................................................ix
Storage, Transportation, and Disposal................................................................................................x
Cleaning and Disinfection...................................................................................................................xi
Precautions for Safe Operation under Electromagnetic Disturbances...............................................xi
Precautions Concerning Interpretation..............................................................................................xii
Precautions Concerning Automatic Analysis of ECG........................................................................xii
Troubleshooting................................................................................................................................xiii
Guidance on Electromagnetic Disturbances....................................................................................xiv
Messages and Remedies.................................................................................................. xviii
Battery............................................................................................................................................ xviii
Thermal ......................................................................................................................................... xviii
Examination......................................................................................................................................xix
File....................................................................................................................................................xix
Communication ................................................................................................................................xix
Chapter 1 General Description
Features of this ECG..........................................................................................................1-1
Intended Purpose............................................................................................................................ 1-1
Indication for Use ............................................................................................................................ 1-1
Convenient Functions...................................................................................................................... 1-2
Names of Parts and Their Functions..................................................................................1-4
Types and Functions of Operation Panel Keys..................................................................1-6
How to Read the LCD.........................................................................................................1-7
How to View the Icons..................................................................................................................... 1-8
Basic Operation Procedure .............................................................................................. 1-10
Display Operation.......................................................................................................................... 1-10
Changing the Examination Type...................................................................................................1-12
Displaying the Menu...................................................................................................................... 1-12
Character Entry.............................................................................................................................1-13

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Contents
Chapter 2 Installation
Notes on Installation Site....................................................................................................2-1
Using the Optional Battery..................................................................................................2-2
Precautions when handling a battery...............................................................................................2-2
Charging the Battery........................................................................................................................2-3
Operating by Battery Power.............................................................................................................2-4
Checking the Remaining Battery Power..........................................................................................2-4
Connecting the Cables .......................................................................................................2-5
Turning ON/OFF the Power................................................................................................2-7
To Turn ON the Power.....................................................................................................................2-7
To Turn OFF the Power...................................................................................................................2-8
Loading the Recording Paper.............................................................................................2-8
Connecting to the Network ...............................................................................................2-11
Example of Network Configuration................................................................................................2-11
Configuring Network Settings........................................................................................................2-12
Connecting Optional Devices ...........................................................................................2-13
Chapter 3 Preparation before Examination
Attaching the Electrodes.....................................................................................................3-1
Before the Attachment.....................................................................................................................3-1
Attachment.......................................................................................................................................3-2
Performing Electrode Check............................................................................................................3-3
Checking the Date and Time..............................................................................................3-3
Selecting the Filters............................................................................................................3-4
Setting the Sensitivity .........................................................................................................3-5
Check Carefully ..................................................................................................................3-5
Chapter 4 Entering Patient Information
Patient Data Categories......................................................................................................4-1
Entering Patient Information...............................................................................................4-2
Loading Information from the DMS (Master ID)..................................................................4-7
Using Information on SD Card............................................................................................4-8
Registering the Patient Information .................................................................................................4-8
Retrieving the Patient Information Using the ID Number.................................................................4-9
Retrieving the Patient Information by Specifying the Patient.........................................................4-10
Searching the Patient Information .................................................................................................4-10
Deleting the Unnecessary Patient Information ..............................................................................4-11

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Chapter 5 12-Lead Examination
Function Keys Used in Examinations.................................................................................5-1
Type of Waveform Recording/Printing................................................................................5-3
Recording/Printing Automatically........................................................................................5-4
Preparation...................................................................................................................................... 5-4
Starting Printing...............................................................................................................................5-4
Examples of Printing .......................................................................................................................5-6
Function that can be used after measurement................................................................................5-9
Correcting the Patient Information................................................................................................. 5-10
Manual Recording/Printing...............................................................................................5-10
Starting Manual Recording/Printing...............................................................................................5-10
Examples of Printing ..................................................................................................................... 5-12
Printing Waveforms from Several Seconds Before (Review Recording/Printing) ............5-13
Principle of Review Printing........................................................................................................... 5-13
How to Perform Review Printing ................................................................................................... 5-13
Printing Commentary........................................................................................................ 5-14
What is Commentary?................................................................................................................... 5-14
Setting to Print Commentary......................................................................................................... 5-14
Printing.......................................................................................................................................... 5-15
Examples of Printing ..................................................................................................................... 5-16
Extending Printing ............................................................................................................ 5-16
Auto Extension..............................................................................................................................5-16
Optional Extension........................................................................................................................5-16
Examples of Printing ..................................................................................................................... 5-17
Printing the Time Comparison Report..............................................................................5-17
Examples of Printing ..................................................................................................................... 5-18
Other Functions................................................................................................................5-18
Printing Marks ............................................................................................................................... 5-18
Resetting the Waveform................................................................................................................5-19
Continuously Printing the Same Lead........................................................................................... 5-19
Printing Two or More Copies of the Same ECG Data...................................................................5-19
Chapter 6 12-Lead Examination (Advanced Function)
Checking the Waveforms using the Freeze Function.........................................................6-2
Freezing the Waveforms.................................................................................................................6-2
Checking the Saved Waveforms........................................................................................6-5
To Perform Auto Printing.................................................................................................................6-6
To Perform Manual Printing ............................................................................................................6-7
Recording the ECG Waveforms at Rest and After Exercise .............................................. 6-9
Details of the Examination...............................................................................................................6-9
To Start Recording........................................................................................................................6-10
Examples of Printing ..................................................................................................................... 6-11
ACS Diagnostic Support Function....................................................................................6-13
Required Settings.......................................................................................................................... 6-14
Entering the ACS Inquiry when Abnormal Finding........................................................................6-14
Entering the ACS Inquiry Before the Examination ........................................................................6-15

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Entering the ACS Inquiry from the Analysis Result Display...........................................................6-16
Functions on the ACS Analysis Result Display .............................................................................6-17
Printing Reports.............................................................................................................................6-17
Examples of Printing......................................................................................................................6-18
Explanation of the Analyzed Result...............................................................................................6-19
Explanation of the ACS Summary Report.....................................................................................6-20
Explanation of the ACS Guide Report...........................................................................................6-20
Auto Capture Function......................................................................................................6-21
Required Settings..........................................................................................................................6-22
Waveform Acquisition....................................................................................................................6-22
R Wave Detection Lead Auto Switch Function.................................................................6-23
Wave Comparison Report ................................................................................................6-23
Examples of Printing......................................................................................................................6-24
Chapter 7 Arrhythmia ECG Examination
Required Settings...............................................................................................................7-1
Setting the Examination Lead..........................................................................................................7-1
Setting the Waveform Recording Time............................................................................................7-2
Printing while Measuring Arrhythmia..................................................................................7-2
Starting Recording/Printing..............................................................................................................7-2
Function that can be used after Measurement................................................................................7-4
Aborting the Examination.................................................................................................................7-4
Examples of Printing........................................................................................................................7-5
Chapter 8 Rhythm Measurement
Printing while Measuring Rhythm Waveform......................................................................8-1
Starting Recording/Printing..............................................................................................................8-1
Functions that can be used after Examination.................................................................................8-3
Examples of Printing........................................................................................................................8-5
Chapter 9 File Transfers
Functions............................................................................................................................9-1
Handling Media...................................................................................................................9-1
Precautions when Using the SD Card/USB Memory.......................................................................9-1
Files and Folders.............................................................................................................................9-2
Initializing the Data .............................................................................................................9-2
Saving Examination Data ...................................................................................................9-3
How to Save Data............................................................................................................................9-3
Saving Data Automatically...............................................................................................................9-3
Saving Data Manually (Simple Operation).......................................................................................9-4

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Saving Manually (File Utility Operation).......................................................................................... 9-4
Saving the Reports in DICOM Format................................................................................9-6
Procedure to Save in DICOM Format ............................................................................................. 9-6
Saving Automatically.......................................................................................................................9-6
Saving Manually (Simple Operation)............................................................................................... 9-6
Saving Manually (File Utility Operation).......................................................................................... 9-7
Saving the Reports in PDF Format..................................................................................... 9-8
Procedure to Save in PDF Format.................................................................................................. 9-8
Saving Automatically.......................................................................................................................9-8
Saving Manually (Simple Operation)............................................................................................... 9-8
Printing the Reports on External Printer...........................................................................9-10
Connecting the External Printer .................................................................................................... 9-10
Procedure to Print on the External Printer.....................................................................................9-10
Printing Automatically.................................................................................................................... 9-10
Printing Manually (Simple Operation)............................................................................................9-11
Reading Examination Data...............................................................................................9-12
Loading.......................................................................................................................................... 9-12
Searching Data..............................................................................................................................9-13
Printing Thermal Reports .............................................................................................................. 9-14
Printing the Data List.....................................................................................................................9-15
Deleting Examination Data...............................................................................................9-15
Deleting Data from the List............................................................................................................ 9-15
Restoring Deleted Data................................................................................................................. 9-16
Correcting Examination Data............................................................................................ 9-17
Copying Examination Data............................................................................................... 9-18
Naming Folders................................................................................................................ 9-19
Changing Folder to Save Data......................................................................................... 9-20
Communication History .................................................................................................... 9-21
Searching Communication History Data ....................................................................................... 9-21
Erasing the Communication History..............................................................................................9-23
Examples of Printing ..................................................................................................................... 9-23
Chapter 10 DICOM Work List
Functions..........................................................................................................................10-1
Preparing for Communication with External Device......................................................... 10-1
Connecting the External Device.................................................................................................... 10-1
Settings Required for Communication........................................................................................... 10-2
Selecting Work List and Conducting Examination............................................................10-3
Searching the Work List Information ................................................................................ 10-4
Fixing the Work List by Connecting the ID Reader........................................................... 10-5
Chapter 11 Ordering System
Functions..........................................................................................................................11-1

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Preparing for Communication with External Devices........................................................11-2
Connecting the Communication Device.........................................................................................11-2
Settings Required for Communication...........................................................................................11-2
Selecting Order Information and Conducting Examination...............................................11-4
Searching Order Information ............................................................................................11-5
Displaying Order Information Using ID Reader .............................................................................11-6
Displaying Comments.......................................................................................................11-7
Chapter 12 Printing Daily Report
Contents of Daily Report...................................................................................................12-1
Printing Daily Report.........................................................................................................12-1
Chapter 13 Settings
Overview of Settings.........................................................................................................13-1
Window Operation Procedure...........................................................................................13-1
ECG Control .....................................................................................................................13-2
General..........................................................................................................................................13-3
Lead/Print ......................................................................................................................................13-3
Sensitivity.......................................................................................................................................13-4
Custom Key...................................................................................................................................13-4
Buzzer Control...............................................................................................................................13-4
Printer Output ................................................................................................................................13-5
Localization....................................................................................................................................13-5
Patient Information ...........................................................................................................13-5
Patient............................................................................................................................................13-6
Dept...............................................................................................................................................13-7
Medicine-Tech. Name....................................................................................................................13-8
File....................................................................................................................................13-9
General..........................................................................................................................................13-9
Storage Conditions......................................................................................................................13-10
PDF..............................................................................................................................................13-10
Communication...............................................................................................................13-10
General........................................................................................................................................13-11
DMS Settings...............................................................................................................................13-11
Ordering.......................................................................................................................................13-12
DICOM.........................................................................................................................................13-12
Shared Folder..............................................................................................................................13-13
Printer..........................................................................................................................................13-13
External Device...............................................................................................................13-14
ID Reader 1 and 2 .......................................................................................................................13-14
12-Lead Examination......................................................................................................13-15
General........................................................................................................................................13-15
File...............................................................................................................................................13-16

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Contents
Freeze......................................................................................................................................... 13-18
Filter ............................................................................................................................................13-19
12-Lead Manual Printing.............................................................................................................13-19
12-Lead Auto Printing.................................................................................................................. 13-19
Extra Recording...........................................................................................................................13-22
Arrhythmia ECG Examination......................................................................................... 13-23
General........................................................................................................................................ 13-23
Filter ............................................................................................................................................13-23
File...............................................................................................................................................13-24
Auto Printing................................................................................................................................ 13-24
Printer Output/PDF...................................................................................................................... 13-24
Rhythm Measurement....................................................................................................13-25
General........................................................................................................................................ 13-25
Filter ............................................................................................................................................13-25
File...............................................................................................................................................13-25
Auto Printing................................................................................................................................ 13-26
Printer Output/PDF...................................................................................................................... 13-26
Post-Load Examination .................................................................................................. 13-26
General........................................................................................................................................ 13-27
Freeze......................................................................................................................................... 13-27
Filter ............................................................................................................................................13-28
Rest (Auto Print).......................................................................................................................... 13-28
Post (Auto Print).......................................................................................................................... 13-31
Post (Periodic Print) .................................................................................................................... 13-33
Post (Other).................................................................................................................................13-36
Extra Recording...........................................................................................................................13-36
Changing Functions Keys on the Examination Screen .................................................. 13-38
Saving and Printing the Settings .................................................................................... 13-39
Saving Settings on a SD Card.....................................................................................................13-39
Printing Settings.......................................................................................................................... 13-39
Chapter 14 Maintenance and Inspection
Daily Check ......................................................................................................................14-1
Daily Check Procedure..................................................................................................................14-1
Periodic Check ................................................................................................................. 14-2
Periodic Check Procedure.............................................................................................................14-3
Electrical Safety Inspection Procedure.............................................................................14-5
Safety Specification of this Device................................................................................................ 14-6
Earth Leakage Current..................................................................................................................14-6
Touch Current ............................................................................................................................... 14-7
Patient Leakage Current (From Patient Connection to Ground) ................................................... 14-7
Patient Leakage Current (When external voltage is applied to SIP/SOP)..................................... 14-7
Patient Leakage Current (When external voltage is applied to patient connection of Type F Applied
Part)............................................................................................................................................... 14-8
Patient Auxiliary Current................................................................................................................14-8
Consumable Parts............................................................................................................14-9
Replacement Period of Consumable Parts...................................................................................14-9
Cleaning and Disinfection............................................................................................... 14-10

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Contents
Cleaning the Device.....................................................................................................................14-10
Cleaning the Accessories............................................................................................................14-11
Correcting the Date and Time.........................................................................................14-12
Chapter 15 Appendix
Specifications ...................................................................................................................15-1
Standard Items .................................................................................................................15-3
System Components ........................................................................................................15-3
Combination Example of Medical and Non-Medical Equipments.....................................15-5
Check List.........................................................................................................................15-6
Glossary ...........................................................................................................................15-9