Page 3: Table Of Contents
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 ..............................
Page 4 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....................
Page 5 Contents 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 ....................
Page 6 Contents 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 ...................
Page 7 Contents 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 ....................
Page 8 Contents 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....................
Page 9 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............................
Page 10 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 ...........................
Page 11: Preface
When repairing or replacing the parts, contact your nearest service representative. If the device is used incorrectly and becomes unusable as a result, Fukuda Denshi is not liable for the malfunction. Use the device only for the purposes specified in this manual.
Page 12: About This Manual
Preface About This Manual About This Manual Expression Used in This Manual  Indications for the Screens and Keys The keys displayed on the screen are indicated by [ ]. (Ex.: [Setting], [To exam], [1/2], etc.) Other indications on the screen are indicated by " ". (Ex.: "12-Lead Exam.", "ID", etc.) The messages displayed on the screen will be indicated by <...
Page 13: Reminders To Use The Device Safely
Preface Reminders to Use the Device Safely Reminders to Use the Device Safely Always use the product in accordance with the method of operation and periodic inspection method described in this manual. Read this manual thoroughly and understand it before using the device. Safety Notations The following safety notations are used throughout this manual.
Page 14: Safety
Preface Reminders to Use the Device Safely Indicates the LAN port. Indicates the USB port. Indicates the SD card slot. Indicates the serial connector. Indicates the ECG synchronized signal output connector. Name and Address of Manufacturer / Date of Manufacture Indicates the name and address of manufacturer, and date of manufacture.
Page 15: Precautions When Using With Other Device
Preface Reminders to Use the Device Safely  Essential Performance The essential performance of this device is displaying and saving the electrocardiogram. For necessary information to perform the test for essential performance and basic safety, refer to service personnel.  Preventive Maintenance The purpose of preventive maintenance is to ensure that the device is in safe operating conditions at all times and prevent potential future problems.
Page 16: System Components (Accessories)
(equivalent with CISPR 32 and CISPR 24).  Only the peripheral products and cables specified by Fukuda Denshi should be connected to this device using the specified procedure. For details of the connection procedure, contact your local Fukuda Denshi service representative.
Page 17: Leakage Current
 Do not drop the device or subject it to strong impact or vibration. It may result in electric shock or a fire hazard. Contact your local Fukuda Denshi service representative if this device is dropped or damaged.  Do not subject the LCD screen to strong impact. Doing so may cause damage.
Page 18 Preface Reminders to Use the Device Safely  Operate the touch panel display with your finger. Using other items may cause damage such as scratching the surface of the touch panel.  Do not attach film or adhesive tape to the touch panel. This may result in malfunction or failure. ...
Page 19: Precautions For Battery Pack
CAUTION  Use a media specified by Fukuda Denshi. Using unspecified media may cause failure to the device, such as damage or loss of ECG data. The warranty does not cover data retrieval or repair that is required when problems such as these are caused by using unspecified items.
Page 20: Storage, Transportation, And Disposal
Reminders to Use the Device Safely CAUTION Inspections  Use only Ethernet hubs specified by Fukuda Denshi when connecting this device to the network (LAN).  When connecting this device to the network (LAN), the LAN cable should be not longer than 50 m. CAUTION Precautions Concerning Use of the USB Wireless LAN Adapter ...
Page 21: Cleaning And Disinfection
Preface Reminders to Use the Device Safely  If the device has not been used for a while, make sure to check that the device operates properly and safely before using it.  Do not allow alcohol or other liquids to enter the device. ...
Page 22: Precautions Concerning Interpretation
Preface Reminders to Use the Device Safely  The use of microwave therapy devices nearby or in an adjacent room may cause malfunction or damage to the ECG. Keep these devices a sufficient distance apart according to the Guidance on Electromagnetic Compatibility.
Page 23: Troubleshooting
Preface Reminders to Use the Device Safely Troubleshooting If a trouble should occur, find the cause and take appropriate measures for recording stable ECG.  AC Interference Caused by the Patient Wash the skin with alcohol or soapy water, and when clip electrodes or chest electrodes are applied, apply enough keratin cream.
Page 24: Guidance On Electromagnetic Disturbances
Preface Reminders to Use the Device Safely Guidance on Electromagnetic Disturbances This device complies with IEC 60601-1-2: 2007 and IEC 60601-2-25 (2011). However, if portable transmitter or wireless LAN equipment is used extremely nearby, the electromagnetic influence may largely exceed the compliance level and may cause unexpected phenomenon such as noise interference on the waveform, etc.
Page 25 Preface Reminders to Use the Device Safely  Compliance to the Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below. The customer or the user of this device should assure that it is used in such an environment. Immunity Test Test Level Compliance Level...
Page 26 Preface Reminders to Use the Device Safely Immunity Test Test Level Compliance Level Electromagnetic Environment/Guidance Radiated RF EM 3 V/m 3 V/m Portable and mobile RF communications equipment Fields 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz should be used no closer to any part of the FX-8400, IEC 61000-4-3 80% AM (2 Hz) 80% AM (2 Hz)
Page 27 Preface Reminders to Use the Device Safely Test Band (MHz) Service Modulation Maximum Distance (V/m) Test Level (V/ Frequency Power (W) (MHz) Immunity test 380 to 390 TETRA 400 specifications for 18 Hz RF wireless 430 to 470 GMRS 460 communications FRS 460 ±5kHz...
Page 28: Messages And Remedies
Messages and Remedies The displayed error messages along with the countermeasures are listed below. REFERENCE  If the error message is still displayed even after trying the countermeasure, stop the examination and contact your local Fukuda Denshi service representative. Battery Message Cause Solution <Replace the backup battery.
Page 29: Examination
Failed to save the data to the media. The failure of the media can be considered. Write down the error code at the end of the message and contact your local Fukuda Denshi service representative. <Please set (media).> The media is not set.
Page 30 (Data Management System) was exceeded. again. <Communication error has occurred.> An error occurred during communication with When this message is displayed, the DMS the DMS (Data Management System). (Data Management System) is not connected. Contact your local Fukuda Denshi service representative.
Page 31: Chapter 1 General Description
Chapter 1 General Description Features of this ECG Chapter 1 General Description This chapter provides information about features, names, functions and basic operation procedure of CardiMax series FX-8400. Features of this ECG The CardiMax series FX-8400 measures a standard 12-lead electrocardiogram (ECG) with high accuracy. The results and ECG waveforms can be recorded and printed.
Page 32: Convenient Functions
Chapter 1 General Description Features of this ECG  Intended Patient  Patients/examinee who needs electrocardiogram examination  Adults  Adolescents  Children For ECG measurement, place the electrodes correctly without shorting each other.  Intended Use Environment  Examination rooms or in/out-patient wards of the hospitals, clinics ...
Page 33 Chapter 1 General Description Features of this ECG  Examination data can be printed clearly on recording paper. By adopting a high-density thermal printing method, clear ECG waveforms can be printed on a 210 mm wide recording paper. Furthermore, patient data and ECG analysis can be printed at the same time. ...
Page 34: Names Of Parts And Their Functions
Names of Parts and Their Functions This section describes parts and their functions of this device. WARNING  Contact your local Fukuda Denshi service representative when connecting with other devices. Otherwise, it may cause hazardous situation such as electric shock to the patient and operator.
Page 35 Chapter 1 General Description Names of Parts and Their Functions 1 Paper tray The recording paper is loaded inside. 2 Thermal Print Head Prints ECG waveforms and measurement values on the recording paper. 3 AC Power Indicator (Blue) When connected to an AC outlet, the indicator will light. 4 Charge Indicator (Blue/Orange) During charging, it will light in blue.
Page 36: Types And Functions Of Operation Panel Keys
Chapter 1 General Description Types and Functions of Operation Panel Keys  Connects the power cable. ( "Connecting the Cables" P2-5) To disconnect from the power source, unplug the power cable from this connector. 15 Potential Equalization Terminal Connects an equipotential line. 16 Battery Slot Insert the Li-ion battery pack here.
Page 37: How To Read The Lcd
Chapter 1 General Description How to Read the LCD 8 Alphanumeric Keys Enters characters and numbers. Use "." to enter a decimal point. 9 Delete Key Deletes entered characters. 10 Enter Key Sets the entered item. 11 Custom Key Users can assign the function to these keys. (4 keys) REFERENCE ...
Page 38: How To View The Icons
Chapter 1 General Description How to Read the LCD 5 [Order] key Touch this to display order information list (Refer to "Chapter 9 Ordering System".) 6 [Menu] key Touch this to display the Menu screen. 7 ECG Display Area Displays ECG waveforms. 8 Message Display Area The alarm message is displayed.
Page 39 Chapter 1 General Description How to Read the LCD USB Memory USB Connection Error Battery Error USB Connection ECG LAN LAN Connection Remaining Capacity of Saving Data: 500 and above USB Connection LAN Connection Error Remaining Capacity of Saving Data: 100 to 499 USB Connection Wireless LAN Connection...
Page 40: Basic Operation Procedure
Chapter 1 General Description Basic Operation Procedure Basic Operation Procedure This section describes setting value selection, numeric input, character input, and common operation procedures. Display Operation  Touch key operation This device is operated using operation panel button and keys that appear in the display. ...
Page 41 Chapter 1 General Description Basic Operation Procedure  Selecting Setting Values Below are procedures for selecting one or more items from multiple setting values displayed. Press the desired setting value.  The display changes as shown below. Unselected Selected When only one item can be selected When multiple items can be selected...
Page 42: Changing The Examination Type
Chapter 1 General Description Basic Operation Procedure Changing the Examination Type Touch [Exam.]. Select the examination. Displaying the Menu Touch [Menu]. 1-12...
Page 43: Character Entry
Chapter 1 General Description Basic Operation Procedure Touch the desired item. Character Entry  Entering ID, Height, Weight Use the alphanumeric keys to enter the patient's height, weight, and ID number. Enter the alphanumeric characters.  [Clear]: All entered alphanumerics are cleared. ...
Page 44 Chapter 1 General Description Basic Operation Procedure 1-14...
Page 45: Chapter 2 Installation
Chapter 2 Installation Notes on Installation Site Chapter 2 Installation This section describes ECG installation, cable connection, power ON/OFF, and paper replacement procedures. Notes on Installation Site Take the following precautions when selecting the installation location. CAUTION  Radio interference occurs if there are strong radiated radio waves nearby (leakage currents, static induction and electromagnetic induction enter by the path shown in the figure).
Page 46: Using The Optional Battery
Chapter 2 Installation Using the Optional Battery Using the Optional Battery This section explains how to install and charge the optional battery pack. WARNING  Installation of the battery should be performed only by our service representative, to avoid any risk of electric shock and burn to the operator or malfunction of the device. ...
Page 47: Charging The Battery
An error occurred in the main unit or battery.  Remove the power cable, wait for a while and then charge the battery again.  If the charge indicator still lights in orange even after recharging, contact Fukuda Denshi. Charging the empty battery will be completed within 3 hours. The charging time varies depending on factors ...
Page 48: Operating By Battery Power
Chapter 2 Installation Using the Optional Battery Operating by Battery Power Turn ON the device by pressing the (ON/OFF) key on the operation panel with the power cable unplugged.  "Turning ON/OFF the Power" P2-7) REFERENCE  The device automatically switches to battery operation when the power cable is unplugged or a power failure occurs while operating on AC power.
Page 49: Connecting The Cables
Chapter 2 Installation Connecting the Cables  <Cannot record due to low battery voltage.>  <The battery voltage is too low. Printing has been canceled.>  <Battery operating. Please switch to the AC power supply.>  <The battery voltage is too low. Cannot access media.> ...
Page 50 Chapter 2 Installation Connecting the Cables  Make sure to plug in the power cable all the way in. To equalize the potential between the devices, connect the potential equalization terminals of this device and other device with the optional potential equalization cable. NOTE ...
Page 51: Turning On/Off The Power
Chapter 2 Installation Turning ON/OFF the Power Turning ON/OFF the Power To Turn ON the Power Check that the AC power indicator is lit in blue. Press the (Power) key on the control panel. Check that a beep sounds when the key is pressed. ...
Page 52: To Turn Off The Power
Chapter 2 Installation Loading the Recording Paper To Turn OFF the Power Check that all operations such as measurements, saving on a media, and transmissions to the PC have been completed. Remove all cables from the patient. Press the (Power) key on the operation panel for 1 second. NOTE ...
Page 53 Chapter 2 Installation Loading the Recording Paper will stop halfway. Make sure that the button is pressed down completely. Turn the paper support and push it in. Press and turn 45° . Set the Z-fold paper, and pull out the first page of Z-fold paper approximately 10 cm. Close the paper tray cover by pressing the center part of the cover.
Page 54 Chapter 2 Installation Loading the Recording Paper  To Set the Roll Paper Press the button to open the paper tray cover. NOTE  If the paper tray button is not pressed down completely, the button and paper tray cover will stop halfway.
Page 55: Connecting To The Network
Chapter 2 Installation Connecting to the Network Close the paper tray cover by pressing the center part of the cover. Press down the paper tray cover until a clicking sound is heard. NOTE  If the paper tray button is stopped halfway, it means that the paper tray cover is not securely closed.
Page 56: Configuring Network Settings
Connecting to the Network CAUTION  Configure and connect to the network as specified by Fukuda Denshi.  Use the Ethernet hub recommended by Fukuda Denshi (IEC 60950 compliant).  The devices connected to the network such as Ethernet hub and PC must be installed 1.5 meters away from the patient area (IEC 60601-1(2005) +A1(2012), ANSI AAMI / ES 60601- 1: A1: 2012+C1: 2009/(R)2012+ A2: 2010/(R)2012).
Page 57: Connecting Optional Devices
Connect the wireless LAN adapter to the connector inside the dummy cover. WARNING  When connecting other devices to this device, contact your local Fukuda Denshi service representative. Otherwise, it may cause hazardous situation such as electric shock to the patient and operator.
Page 58 Chapter 2 Installation Connecting Optional Devices 2-14...
Page 59: Chapter 3 Preparation Before Examination
Chapter 3 Preparation before Examination Attaching the Electrodes Chapter 3 Preparation before Examination This section describes procedures for attaching the electrodes, handling external media, and setting filter. Attaching the Electrodes Attach the electrodes to the patient. ECG recordings are affected significantly by the way the electrodes are attached. Read the following explanation carefully and take care to attach the electrodes correctly.
Page 60: Attachment
Chapter 3 Preparation before Examination Attaching the Electrodes Attachment  Attaching the Electrodes: Limbs (4 areas) When "Clip electrodes TE- " or "Clip electrodes TEE-" is applied Attach the wrist clips several centimeters above the wrist and close them securely so that they do not wobble. Attach the ankle clips so that the electrodes touch the backs of the inner ankles and close them securely so that they do not wobble.
Page 61: Performing Electrode Check
Chapter 3 Preparation before Examination Checking the Date and Time Performing Electrode Check Check the condition of electrode attached to the patient and the condition of lead. When "Lead Off Display" is set to [Picture] in the setting, electrodes can be checked. Touch [Electrode Status] to display the electrode status window.
Page 62: Selecting The Filters
Chapter 3 Preparation before Examination Selecting the Filters Selecting the Filters A filter can be used to remove noise that affects ECG waveforms. Types of filters that can be set are as follows: The following filters can be turned ON (enabled) or OFF (disabled). Filter Types On-screen Description...
Page 63: Setting The Sensitivity
Chapter 3 Preparation before Examination Setting the Sensitivity To carry out detail setup, touch [Details]. The detailed settings window is displayed.  Set the filter property to "Strong", "Weak" or "OFF" for each filter. Press [X] or [Back] to end the setting. Setting the Sensitivity It is possible to set the sensitivity (waveform amplitude) of waveforms that are displayed or printed.
Page 64 Chapter 3 Preparation before Examination Check Carefully  Is the power cable connected properly when used with the AC power?  Is the cable connection secure?  Is the power cable properly arranged and are not tangled with other cables? ...
Page 65: Chapter 4 Entering Patient Information
Chapter 4 Entering Patient Information Patient Data Categories Chapter 4 Entering Patient Information Enter the name, age, and gender of the patient. There are following 5 methods to enter the information. 1 Procedure for manually entering items such as age, gender, name, height, weight, and medicine information. ...
Page 66 Chapter 4 Entering Patient Information Entering Patient Information Respiration Respiration Rate 3 digits Max. 999 Rate Doctor Name of the doctor in charge Code: 2 digits to 12 digits Alphanumeric characters and symbols can Doctor 1-2 can be used be entered. to enter a total of 2 items Up to 100 items each can be registered for 24 single-byte characters...
Page 67 Chapter 4 Entering Patient Information Entering Patient Information Enter the ID number using the numeric keys. REFERENCE  The window set under [Patient Information] - [Patient] - [General] - [Auto Window (Other)] will be displayed. For example, when set to "ID", "ID" window will be displayed. ...
Page 68 Chapter 4 Entering Patient Information Entering Patient Information Enter the name of the patient.  Refer to "Character Entry" P1-13 for the procedure to enter characters. Select the department. Touch the appropriate department classification (Dept. 1 or 2) . To enter a department code, touch [Enter Code] and enter the code using the numeric keys. ...
Page 69 Chapter 4 Entering Patient Information Entering Patient Information Enter medicine. The code and medicine name can be changed by touching the applicable medicine and then touching [Change]. (The medicines with codes 1 to 10 cannot be changed.) Enter the symptoms. The code and symptom name can be changed by touching the applicable symptom and then touching [Change].
Page 70 Chapter 4 Entering Patient Information Entering Patient Information Enter the body position. Touch Supine/Sitting/Standing. Enter the respiration rate. Enter the respiration rate using the numeric keys. Enter the doctor and technician. The code, doctor, and technician names can be changed by touching the applicable number and then touching [Change].
Page 71: Loading Information From The Dms (Master Id)
Chapter 4 Entering Patient Information Loading Information from the DMS (Master ID) Loading Information from the DMS (Master ID) The patient information can be searched and loaded from the DMS by entering the ID number. The following items can be loaded using Master ID. First name/Last name Weight Medicine 1...
Page 72: Using Information On Sd Card
Chapter 4 Entering Patient Information Using Information on SD Card there is no patient information corresponding to the specified ID number.  ID numbers can also be loaded from an ID reader. In this case, the patient information is loaded from the DMS automatically when the ID number is loaded from the ID reader. ...
Page 73: Retrieving The Patient Information Using The Id Number
Chapter 4 Entering Patient Information Using Information on SD Card Retrieving the Patient Information Using the ID Number Use the ID number to load the patient information from the SD card. Touch the patient information display area to display in the Patient Information Setting window. Enter the ID number.
Page 74: Retrieving The Patient Information By Specifying The Patient
Chapter 4 Entering Patient Information Using Information on SD Card Retrieving the Patient Information by Specifying the Patient Load the patient information from the SD card before performing an examination. Touch "Media".  The patient information list is displayed. Select a patient. ...
Page 75: Deleting The Unnecessary Patient Information
 When the name is entered, the names containing character strings are searched. For example, when "Fuku" is entered, names such as "Fukuda", "Fukuyama" and "Kofuku" will be retrieved. When searching by examination date, enter the examination date of the desired data.
Page 76 Chapter 4 Entering Patient Information Using Information on SD Card  More than one patient information can be selected for deletion. Touch [Delete]. When the confirmation message window appears, touch [Execute].  The specified patient information is deleted from the SD card. ...
Page 77 Chapter 5 12-Lead Examination Function Keys Used in Examinations Chapter 5 12-Lead Examination This chapter describes the basic method for recording an ECG. The basic process for conducting standard ECG examinations is as follows:  Setup Configure the various settings as necessary. ...
Page 78 Chapter 5 12-Lead Examination Function Keys Used in Examinations  Auto Mode (while printing) Hold Mark Extend Printing  Manual Mode (while not printing) Freeze Auto/Manual Electrode Status 25mm/s ↓ Touch [1/4] to switch displays. Interval Channels Window Selection Feed ↓...
Page 79: Chapter 5 12-Lead Examination
Chapter 5 12-Lead Examination Type of Waveform Recording/Printing  While printing compressed waveform Mark *1: Displayed only when there is a previous examination. *2: By touching [Hold], extended recording/printing of the lead block currently being recorded/printed will be  performed. ( "Extending Printing"...
Page 80: Recording/Printing Automatically
Chapter 5 12-Lead Examination Recording/Printing Automatically  Panorama report, ACS summary report, ACS guide report, Brugada risk analysis report, analysis report, and commentary report can be printed only when an optional software is installed. Recording/Printing Automatically EGC data are recorded automatically. ECG waveforms are measured according to the settings and printed in a prescribed format.
Page 81 Chapter 5 12-Lead Examination Recording/Printing Automatically  When the power is turned ON, the 12-lead examination is displayed. Enter patient information. (Refer to Chapter 4 "Entering Patient Information".)  Attach the ECG electrodes and check that an ECG appears in the display. ( "Attaching the Electrodes"...
Page 82: Examples Of Printing
Chapter 5 12-Lead Examination Recording/Printing Automatically  The recorded content is printed in the specified waveform report format. The printing will automatically stop when completed.  To stop printing press the (START/STOP) key.  Printing can be extended by touching [Extend Printing] on the touch panel while printing ECG. ...
Page 83 Chapter 5 12-Lead Examination Recording/Printing Automatically ● Auto Printing (Result Report) The printing example of the following is shown: Result Report: DOM1 ● Auto Printing (Result Report) The printing example of the following is shown: Result Report: FULL6 ● Auto Printing (Result Report) The printing example of the following is shown: Result Report: Cover...
Page 84 Chapter 5 12-Lead Examination Recording/Printing Automatically ● Analysis Report The following settings are required. Set “Interpret.” for [12-Lead Exam.] - [12-Lead Auto Print] - [Results Report 1] - [Analysis Report]. ● Commentary Report The following settings are required. Set “Interpret.” for [12-Lead Exam.] - [12-Lead Auto Print] - [Results Report 1] - [Commentary Report].
Page 85: Function That Can Be Used After Measurement
Chapter 5 12-Lead Examination Recording/Printing Automatically Function that can be used after measurement The following items can be confirmed in the Measurement Result window before printing a result report. Flick left or right on the screen to switch display in the Measurement Result window. It is also possible to select the window to be shown by touching [Window] and selecting the display from the Window Selection window.
Page 86: Correcting The Patient Information
Chapter 5 12-Lead Examination Manual Recording/Printing Correcting the Patient Information In the examination result display, patient information can be corrected. Refer to Chapter 4 "Entering Patient Information" for the operation procedure. NOTE  Make sure to save data in order to enable editing. If it is not saved, edits will not be reflected. Manual Recording/Printing The ECG can be printed by manually changing lead and sensitivity.
Page 87 Chapter 5 12-Lead Examination Manual Recording/Printing Select manual printing.  The default setting is "Auto".  Touch [Auto/Manual] to switch between auto printing and manual printing. The current setting is displayed in bold.  When "Auto" is set: The leads will be normally displayed. ...
Page 88: Examples Of Printing
Chapter 5 12-Lead Examination Manual Recording/Printing Press the (START/STOP) key on the operation panel to start acquiring waveforms.  Acquiring of waveforms will start, and <Acquiring waveforms...> will be displayed.  Press the (1mV) key on the operation panel to print the 1 mV calibration waveforms. ...
Page 89: Printing Waveforms From Several Seconds Before (Review Recording/Printing)
Chapter 5 12-Lead Examination Printing Waveforms from Several Seconds Before (Review Recording/Printing) Printing Waveforms from Several Seconds Before (Review Recording/Printing) Principle of Review Printing Usually, waveforms are printed by pressing the (START/STOP) key on the operation panel, which prints waveforms for the specified period of time from the time the key was pressed. When the (REVIEW) key is pressed, ECG of the specified time period will be printed up to the point when the key was pressed.
Page 90: Printing Commentary
Chapter 5 12-Lead Examination Printing Commentary Printing Commentary REFERENCE  Analysis report and commentary report can be printed when an optional software is installed. What is Commentary? Two types of reports are printed for the interpretations obtained in analyses: an Analysis Report, which explains why that interpretation was given and a Commentary Report, which provides a detailed explanation of the interpretation.
Page 91: Printing
Chapter 5 12-Lead Examination Printing Commentary  [Interpret.]: The content is printed for all interpretations.  [No]: Analysis guides and commentary are not printed. Printing  Printing Analysis Report Conduct 12-lead examination. When the examination results appear, swipe the display left or right to display the "Analysis Results" and select the interpretation to print.
Page 92: Examples Of Printing
Chapter 5 12-Lead Examination Extending Printing Examples of Printing ● Analysis Report ● Commentary Report Extending Printing Auto Extension REFERENCE  To extend printing automatically, set "Yes" for [12-Lead Exam.] - [12-Lead Auto Print] - [Auto Extension] - [Auto Print Extension] in the Settings beforehand. Printing can be extended automatically when the finding grade exceeds a fixed value.
Page 93: Examples Of Printing
Chapter 5 12-Lead Examination Printing the Time Comparison Report Examples of Printing ●Extension Printing (Waveform Report) ●Extension Printing (Result Report) Printing the Time Comparison Report For the standard ECG examination, the 12-lead dominant waveforms of the previous examination can be printed on the results report along with the waveforms of the current examination.
Page 94: Examples Of Printing
Chapter 5 12-Lead Examination Other Functions  If a password is set to access the file list, an authentication window will be displayed before printing.In such case, enter the password to start printing. Examples of Printing ●Time Comparison Report 4 seconds of waveforms for both limb lead and chest lead will be printed.
Page 95: Resetting The Waveform
Chapter 5 12-Lead Examination Other Functions Resetting the Waveform Pressing the (RESET) key on the operation panel resets the input waveform and displays and prints a baseline for the duration that the key is pressed. Press the (RESET) key on the operation panel. Continuously Printing the Same Lead The same lead can be continuously printed using Auto Printing.
Page 96 Chapter 5 12-Lead Examination Other Functions 5-20...
Page 97: Chapter 6 12-Lead Examination (Advanced Function)
Chapter 6 12-Lead Examination (Advanced Function) Chapter 6 12-Lead Examination (Advanced Function) This section explains the advanced operation procedure of the 12-lead examination.  Checking the Waveforms using the Freeze Function  Freezing the Waveforms ( P6-2 )  Printing the Saved Waveforms ( P6-5 ) ...
Page 98: Checking The Waveforms Using The Freeze Function
Chapter 6 12-Lead Examination (Advanced Function) Checking the Waveforms using the Freeze Function Checking the Waveforms using the Freeze Function When arrhythmia appears, the ECG waveform can be printed or the waveform trace can be stopped for closer observation.Waveforms of up to 5 minutes are captured and displayed. On the freeze display, swipe left or right, or touch [Switch Display] to switch the display in the order of 6ch waveform (limb) →...
Page 99 Chapter 6 12-Lead Examination (Advanced Function) Checking the Waveforms using the Freeze Function Check the waveform on the freeze display. The following operations can be performed.  Viewing the Waveforms of Other Leads Flick the screen, or touch [Switch Display] to switch the display between limb lead and chest lead of 6ch waveform.
Page 100 Chapter 6 12-Lead Examination (Advanced Function) Checking the Waveforms using the Freeze Function  The waveforms with green background will be measured, and the results will be displayed. The following operations can be performed.  Switching the Display Touch [Display] to display the selection window for the display type. Select the display type. ...
Page 101: Checking The Saved Waveforms
Chapter 6 12-Lead Examination (Advanced Function) Checking the Saved Waveforms Checking the Saved Waveforms When the freeze operation is performed, the ECG waveform of maximum 5 minutes will be saved. The saved waveform can be displayed as rhythm waveform, and can be printed automatically or manually. Touch [Freeze].
Page 102: To Perform Auto Printing
Chapter 6 12-Lead Examination (Advanced Function) Checking the Saved Waveforms To Perform Auto Printing  Freeze the waveform and display the rhythm waveform. ( "Checking the Saved Waveforms" P6-5) Touch [Auto/Manual] to set to auto printing mode.  Verify that "Auto" is displayed for the function key. Touch [Rhythm Waveform] to set the auto printing range.
Page 103: To Perform Manual Printing
Chapter 6 12-Lead Examination (Advanced Function) Checking the Saved Waveforms Change the [Meas. Range]. Select one of the following to change the Meas. Range. Reset: The range set under "Setting" will be applied. Zoom In: Adds one second each to the beginning and end of the recording range. Zoom Out: Reduces one second each to the beginning and end of the recording range.
Page 104 Chapter 6 12-Lead Examination (Advanced Function) Checking the Saved Waveforms Touch [Recording Range]. Specify the starting and ending point. [Start Point]: Allows to set the starting point. [End Point]: Allows to set the ending point. [All Wave]: All waveforms will be included in the range. [Back]: The range setting mode will end.
Page 105: Recording The Ecg Waveforms At Rest And After Exercise
Chapter 6 12-Lead Examination (Advanced Function) Recording the ECG Waveforms at Rest and After Exercise Recording the ECG Waveforms at Rest and After Exercise By using this function, ECG waveforms at rest and after exercise can be recorded. Details of the Examination The ECG waveforms of the following two conditions can be recorded.
Page 106: To Start Recording
Chapter 6 12-Lead Examination (Advanced Function) Recording the ECG Waveforms at Rest and After Exercise To Start Recording Touch [Exam.]. Touch [Post].  Record the resting ECG waveform. (' "12-Lead Examination" P5-1') Have the patient do some exercise such as walking. Touch [Interval].
Page 107: Examples Of Printing
Chapter 6 12-Lead Examination (Advanced Function) Recording the ECG Waveforms at Rest and After Exercise REFERENCE  By configuring [Setting] - [Post-Load Exam] - [Post (Period. Print)] - [Interval Printing] - [Print at Set Time], printing can be performed at specified time. ...
Page 108 Chapter 6 12-Lead Examination (Advanced Function) Recording the ECG Waveforms at Rest and After Exercise ●Post-Exercise (Manual Printing) ●Post-Exercise (Summary Report) ●Post-Exercise (Result Report) The printing example of the following is shown: Result Report: DOM1 6-12...
Page 109: Acs Diagnostic Support Function
Chapter 6 12-Lead Examination (Advanced Function) ACS Diagnostic Support Function ●Periodic Compressed Printing The printing example of the following is shown: Compressed Printing: 5 mm/s Lead: Spare Lead 1 (6ch) Calibration Position: After Waveform ACS Diagnostic Support Function REFERENCE  The ACS diagnostic support function can be used when the optional software is installed. Analyzing using the ACS diagnostic support function can be performed during the 12-lead examination.
Page 110: Required Settings
Chapter 6 12-Lead Examination (Advanced Function) ACS Diagnostic Support Function  Save  Saving the Examination Data ( P9-3 ) NOTE  The ACS inquiry can be entered before the examination, after the analysis, or during checking the analysis result. For details, refer to each section. Required Settings Select "Yes"...
Page 111: Entering The Acs Inquiry Before The Examination
Chapter 6 12-Lead Examination (Advanced Function) ACS Diagnostic Support Function Enter the ACS inquiry.  [Next]: Proceeds to next inquiry.  [Complete]: Ends the inquiry.  The analysis result will be displayed. ( "Functions on the ACS Analysis Result Display" P6-17) Entering the ACS Inquiry Before the Examination Select "Always"...
Page 112: Entering The Acs Inquiry From The Analysis Result Display
Chapter 6 12-Lead Examination (Advanced Function) ACS Diagnostic Support Function Enter the ACS inquiry.  [Next]: Proceeds to next inquiry.  [Complete]: Ends the inquiry.  Continue the ECG examination at rest. ( "12-Lead Examination" P5-1) Entering the ACS Inquiry from the Analysis Result Display On the analysis result display, touch [ACS Inquiry] on the function key (3/3).
Page 113: Functions On The Acs Analysis Result Display
Chapter 6 12-Lead Examination (Advanced Function) ACS Diagnostic Support Function REFERENCE  The result may change when reanalysis is performed.  ACS inquiry cannot be entered from the file analysis result display. Functions on the ACS Analysis Result Display  The synthesized ECG waveform can be displayed.
Page 114: Examples Of Printing
Chapter 6 12-Lead Examination (Advanced Function) ACS Diagnostic Support Function Examples of Printing ●ACS Summary Report The following setting is required. Select "Always" or "Abnormal Finding" for "ACS Summary Report" under [Setting] - [12-Lead Exam.] - [12-Lead Auto Print] - [Result Report 2]. ●ACS Guide Report The following setting is required.
Page 115: Explanation Of The Analyzed Result
Chapter 6 12-Lead Examination (Advanced Function) ACS Diagnostic Support Function Explanation of the Analyzed Result 1 Extracted Waveform Display Area The extracted waveform is displayed. When the synthesized ECG analysis is performed, the synthesized waveform of the analyzed lead will be displayed.
Page 116: Explanation Of The Acs Summary Report
Chapter 6 12-Lead Examination (Advanced Function) ACS Diagnostic Support Function 6 Occluded Vessel Analysis Result The result comment for occluded vessel analysis will be displayed. 7 Clinical ECG Analysis Result The 12-lead analysis result will be displayed. Explanation of the ACS Summary Report 1 ECG Waveform Area The dominant waveforms are displayed.
Page 117: Auto Capture Function
Chapter 6 12-Lead Examination (Advanced Function) Auto Capture Function 1 ST Level The ST level of right-sided leads, posterior leads will be displayed. 2 ACS Detailed Measurement The detailed measurement of right-sided leads, posterior leads will be displayed. 3 Result Display Section [ACS Reference ECG] The representative interpretation and explanation of suggestive ACS will be displayed.
Page 118: Required Settings
Chapter 6 12-Lead Examination (Advanced Function) Auto Capture Function NOTE  This function cannot be used simultaneously with ordering function. Required Settings Select "Yes" for "Auto Capture Function" under [Setting] - [12-Lead] - [General]. NOTE  If the ordering function is enabled, the setting can not be changed. Waveform Acquisition When the electrodes are attached, or when the lead-off condition is resolved, the waveform acquisition will start.
Page 119: R Wave Detection Lead Auto Switch Function
Chapter 6 12-Lead Examination (Advanced Function) R Wave Detection Lead Auto Switch Function R Wave Detection Lead Auto Switch Function The R wave detection lead can be automatically switched. Select "Auto" for "R wave detection lead" under [Setting] - [12-Lead] - [General] - [Lead]. Display the examination screen.
Page 120: Examples Of Printing
Chapter 6 12-Lead Examination (Advanced Function) Wave Comparison Report Touch the [Compare Waveforms] function key.  The wave comparison report will be printed. REFERENCE  Maximum of 10 data can be selected for wave comparison report.If more than 10 data are selected, the wave comparison report of the latest 10 data will be printed.
Page 121: Chapter 7 Arrhythmia Ecg Examination
Chapter 7 Arrhythmia ECG Examination Required Settings Chapter 7 Arrhythmia ECG Examination This chapter explains the procedure for 3-lead arrhythmia examination. The basic procedure for arrhythmia examination is as follows.  Setup Configure the settings as necessary.  Configuring Settings for Arrhythmia Examinations (Leads, Filters, Files, etc.) ( P13-23 ) ...
Page 122: Setting The Waveform Recording Time
Chapter 7 Arrhythmia ECG Examination Printing while Measuring Arrhythmia It can also be set by touching [Lead] in the examination display. Setting the Waveform Recording Time Select the duration to acquire waveforms. This can be set in [Arrhythmia ECG] - [Auto Printing] - [Duration] in the Settings. It can also be set by touching [Time] in the examination display.
Page 123 Chapter 7 Arrhythmia ECG Examination Printing while Measuring Arrhythmia Enter patient information. (Refer to Chapter 4 "Entering Patient Information".)  Attach the ECG electrodes and check that ECG waveforms appear on the display. ( "Attaching the Electrodes" P3-1) REFERENCE  The examination leads can be set under [Settings] or by touching the [Lead] function key.
Page 124: Function That Can Be Used After Measurement
Chapter 7 Arrhythmia ECG Examination Printing while Measuring Arrhythmia Function that can be used after Measurement The following items can be checked on the result display before printing a report. The display can be switched in two ways. Flick left or right on the screen Touch [Display] directly.
Page 125: Examples Of Printing
Chapter 7 Arrhythmia ECG Examination Printing while Measuring Arrhythmia Examples of Printing ● Arrhythmia Waveform Report The printing example of the following is shown: Examination Lead: II, aVF, V5 Waveform Acquiring Time: 40 seconds Waveform Report Format: 10 mm/s ● Arrhythmia Detailed Measurement Report ●Arrhythmia Analysis Result Report The printing example of the following is shown:...
Page 126 Chapter 7 Arrhythmia ECG Examination Printing while Measuring Arrhythmia...
Page 127: Chapter 8 Rhythm Measurement
Chapter 8 Rhythm Measurement Printing while Measuring Rhythm Waveform Chapter 8 Rhythm Measurement This chapter describes the rhythm measurements examination. The basic process for conducting rhythm measurement examination is as follows:  Setup Configure the various settings as necessary.  "Rhythm Measurement"...
Page 128 Chapter 8 Rhythm Measurement Printing while Measuring Rhythm Waveform Touch [Rhythm Meas.].  When the power is turned ON, the 12-lead examination is displayed.  Attach the electrodes of the recording lead to the patient. ( "Attaching the Electrodes" P3-1) ...
Page 129: Functions That Can Be Used After Examination
Chapter 8 Rhythm Measurement Printing while Measuring Rhythm Waveform Select the examination lead. Press the (Start/Stop) key on the operation panel.  The examination starts. "Acquiring waveforms..." is displayed and the time count starts. When the time set in step 5 has elapsed, the examination finishes and the acquired waveforms are printed on the recording paper.
Page 130 Chapter 8 Rhythm Measurement Printing while Measuring Rhythm Waveform ●[Result Waveform] ●[R-R Trend] The measured rhythm waveform will be displayed. The R-R trend graph will be displayed. ●[Detailed Value] ●[R-R Histogram] The detailed measurement value will be displayed. The R-R histogram will be displayed. ●...
Page 131: Examples Of Printing
Chapter 8 Rhythm Measurement Printing while Measuring Rhythm Waveform Examples of Printing ● R-R Measurement Waveform Report (Waveform) Examination condition Examination time: 1 minute Examination lead: II ● Rhythm Result Report Examination condition Examination time: 1 minute Examination lead: II REFERENCE ...
Page 132 Chapter 8 Rhythm Measurement Printing while Measuring Rhythm Waveform...
Page 133: Chapter 9 File Transfers
CAUTION  Make sure to use the specified USB memory.  If media other than those specified by Fukuda Denshi are used, examination data may not be saved correctly or the recorded data may not be loaded.  Make sure to format the media before using it for the first time.
Page 134: Files And Folders
 Formatting these will clear all data saved on the media. Make sure to check that important  data is not contained in the media before formatting it. ( "Reading Examination Data" P9-  Use only the SD card, USB memory specified by Fukuda Denshi. Insert the storage media into this device.
Page 135: Saving Examination Data
Chapter 9 File Transfers Saving Examination Data Touch [Menu] - [File/Communication] - [Media Mgmt.] - [Format]. Select the media and format type. Make sure that correct media and format type is selected, and touch [Execute].  Formatting will start.  When the formatting is completed, <Finished formatting media>...
Page 136: Saving Data Manually (Simple Operation)
Chapter 9 File Transfers Saving Examination Data Saving Data Manually (Simple Operation) Manually save examination data on the specified media after each examination is finished. Perform an examination. Insert the storage media into this device.  If the media is not formatted, format it first. ...
Page 137 Chapter 9 File Transfers Saving Examination Data Touch [Menu] - [File/Communication] - [File List], then touch [Media] function key. Select internal memory for the copy source. Touch [Internal Memory], and then touch [ Touch the data to save. When the data is highlighted, touch [Copy] (function key). [Touch [ ] and copy.
Page 138: Saving The Reports In Dicom Format
Chapter 9 File Transfers Saving the Reports in DICOM Format Saving the Reports in DICOM Format The examination reports recorded on this device can be saved in DICOM formats. The destination to save the reports can be selected from the following. Save to DICOM Storage with online operation.
Page 139: Saving Manually (File Utility Operation)
Chapter 9 File Transfers Saving the Reports in DICOM Format Saving Manually (File Utility Operation) The report image to save can be selected using the file utility function. Conduct the examination. Connect the DICOM Storage or set the SD card for DICOM DIR to this device. ...
Page 140: Saving The Reports In Pdf Format
Chapter 9 File Transfers Saving the Reports in PDF Format Touch [Save to DICOM]. Saving the Reports in PDF Format The examination reports can be saved in PDF format to SD card, USB memory, or shared folder. Procedure to Save in PDF Format There are following 2 ways to save the examination reports in PDF format.
Page 141 Chapter 9 File Transfers Saving the Reports in PDF Format Touch [Save PDF] on the result screen when the examination is completed. REFERENCE  The [Save PDF] key is displayed only when "Thermal" is selected for "Print Method" under [ECG Control] - [Lead/Print]. Select the report type on the "Save PDF"...
Page 142: Printing The Reports On External Printer
Connect the Ethernet hub to the LAN connector of this device. NOTE  For information on LAN network, contact your local Fukuda Denshi service representative.  Use the IEC 60950 compliant Ethernet hub. Procedure to Print on the External Printer There are following 2 ways to print the examination reports on external printer.
Page 143: Printing Manually (Simple Operation)
Chapter 9 File Transfers Printing the Reports on External Printer  The directly written waveform report will be printed only on the thermal printer regardless of the setting. REFERENCE  The report type to print on the external printer can be selected using the [Printer Output/PDF] function key on each examination screen.
Page 144: Reading Examination Data
Chapter 9 File Transfers Reading Examination Data Reading Examination Data The examination data can be read from the media to review on this device. This section also explains how to print the loaded data and data list. Loading Insert the media to read the data. Touch [Menu] - [File/Communication] - [File List] - [Media].
Page 145: Searching Data
Chapter 9 File Transfers Reading Examination Data  Touch [Back] to return to the file list display.  When multiple data are selected, the examination results will be displayed sequentially. Touch [Next] in the result display to display the next examination results. ...
Page 146: Printing Thermal Reports
Chapter 9 File Transfers Reading Examination Data  All examination dates are set as search targets by default.  An examination start date and end date can be entered. If no start date is entered, all data items before the end date are search targets.
Page 147: Printing The Data List
Chapter 9 File Transfers Deleting Examination Data Printing the Data List Touch [1/4] - [2/4] - [LIST] in the data list window.  The data list is printed. Deleting Examination Data Deleting Data from the List Deleting data from the list simply means that it is no longer displayed in the list. The data is still stored on the media. NOTE ...
Page 148: Restoring Deleted Data
Chapter 9 File Transfers Deleting Examination Data Touch [Delete]. Touch [Execute].  The data is deleted from the list.  To restore the deleted data, follow the steps in  "Restoring Deleted Data" P9-16. Restoring Deleted Data Data deleted from the list is moved to the [Trash Box]. Data in the Trash Box can be restored. Touch [1/4] - [Trash Box] in the data list window.
Page 149: Correcting Examination Data
Chapter 9 File Transfers Correcting Examination Data Touch [1/4] - [Recover]. In the confirmation window, touch [Yes].  The data is restored. REFERENCE  Data in the Trash Box cannot be completely removed from media. Correcting Examination Data Examination data can be edited before saving or retrieving the data. NOTE ...
Page 150: Copying Examination Data
 The copy destination media can be selected from SD card, USB memory or DMS.  The data cannot be copied from FDA-XML format media to DMS or FUKUDA format media. Insert the media of copy source and copy destination to this device.
Page 151: Naming Folders
Chapter 9 File Transfers Naming Folders Touch [Copy]. Check the media to copy the data and touch [  To change the media to copy the data, press [Change]. When data is copied from media to DMS, the registered icon is displayed.
Page 152: Changing Folder To Save Data
Chapter 9 File Transfers Changing Folder to Save Data Select the folder to change the name. Touch the folder, and then touch [Change Name]. Enter the new name.  Enter any name in alphanumeric characters. This is entered in the same way as the name in Patient Information. (Refer to Chapter 4 "Entering Patient Information".) [Touch [ ...
Page 153: Communication History
Chapter 9 File Transfers Communication History  The folder management screen will be displayed. Select the media to save the data. Select the folder to save the data. Touch [Folder]. Communication History The latest 500 communication data items are recorded. This section explains how to search or erase history of communication with DMS or media.
Page 154 Chapter 9 File Transfers Communication History Touch the item to be used as a search condition and enter the condition. Searching by Data Number  Enter the desired data number.  All numbers are set as search targets by default. ...
Page 155: Erasing The Communication History
Chapter 9 File Transfers Communication History Erasing the Communication History Touch [Erase History] to erase communication history. Examples of Printing ● File List 9-23...
Page 156 Chapter 9 File Transfers Communication History 9-24...
Page 157: Chapter 10 Dicom Work List
Preparing for Communication with External Device Connecting the External Device Connect the Ethernet hub to the LAN connector of this device. NOTE  For information on LAN network, contact your local Fukuda Denshi service representative.  Use the IEC 60950 compliant Ethernet hub. 10-1...
Page 158: Settings Required For Communication
Set the name, IP address, sub-network mask of this device and the host as well as the port number and the host number for connection. NOTE  Contact Fukuda Denshi for setting the IP address, port number, etc. required for communication via LAN connection. Touch [Menu] - [Settings] - [Communication].
Page 159: Selecting Work List And Conducting Examination
Chapter 10 DICOM Work List Selecting Work List and Conducting Examination Selecting Work List and Conducting Examination This device can be connected to the DICOM MWM server via LAN. The patient information such as name, age, gender can be retrieved from the work list information on the DICOM MWM server.
Page 160: Searching The Work List Information
Chapter 10 DICOM Work List Searching the Work List Information Touch [To exam]. The patient information of the selected work list will be reflected.  When the patient information window is closed, starting of the examination will be notified to the MPPS server.
Page 161: Fixing The Work List By Connecting The Id Reader
Chapter 10 DICOM Work List Fixing the Work List by Connecting the ID Reader examination.  When the patient information is entered from the work list, the current patient information will be overwritten.  If the ID is changed after the work list is fixed, the canceling of work list will be notified to the MPPS.
Page 162 Chapter 10 DICOM Work List Fixing the Work List by Connecting the ID Reader 10-6...
Page 163: Chapter 11 Ordering System
Chapter 11 Ordering System Functions Chapter 11 Ordering System This section describes the ordering system of this device. Functions The results of the examination conducted by receiving requests (ordering function) can be saved to the specified media or data management system (DMS) and notified to the DMS or ordering PC. To enable ordering function, select "Ordering"...
Page 164: Preparing For Communication With External Devices
Set the name, IP address, sub-network mask of this device and the host as well as the port number and the host number for connection. NOTE  Contact Fukuda Denshi for setting the IP address, port number, etc. required for communication via LAN connection. 11-2...
Page 165 Chapter 11 Ordering System Preparing for Communication with External Devices Touch [Menu] - [Settings] - [Communication]. Specify the operation mode for ordering. Touch [Ordering]. Set the operation mode to "Online". Touch [DMS Settings]. Set the [Subnet mask], [Default gateway]. Set the host information. Touch [Host Info].
Page 166: Selecting Order Information And Conducting Examination
Chapter 11 Ordering System Selecting Order Information and Conducting Examination Selecting Order Information and Conducting Examination Obtain the order information, and display the order information list. Select an order from the list and perform the examination. REFERENCE  For procedure of each examination, refer to the respective chapter in this operation manual. Touch [Order].
Page 167: Searching Order Information
Chapter 11 Ordering System Searching Order Information Touch and highlight the data to be loaded.  Confirm the order selection.  Only one order can be specified. Touch the examination type icon for the conducting examination. A mark will be displayed for the icon. Touch [To exam].
Page 168: Displaying Order Information Using Id Reader
Chapter 11 Ordering System Searching Order Information Specify search conditions. Examination status  Specify the examination status  When "Unperformed Orders" is selected, an order for which examination has not been performed is specified. Device ID  Enter the device ID. ...
Page 169: Displaying Comments
Chapter 11 Ordering System Displaying Comments Displaying Comments Comment specified in DMS (Data Management System) when ordering is displayed. The comment received from DMS is specified in [Patient Info.] - [Medicine - Tech Name] -[Comment] in the Settings. Specify whether or not to enter comment. Touch [Menu] - [Settings] - [Patient Information] - [Medicine - Tech Name].
Page 170 Chapter 11 Ordering System Displaying Comments 11-8...
Page 171: Chapter 12 Printing Daily Report
Chapter 12 Printing Daily Report Contents of Daily Report Chapter 12 Printing Daily Report This chapter explains how to save/print the examination daily report. Contents of Daily Report To check the status of examinations that have been conducted, the recorded data can be saved as a daily report list in CSV format on a SD card.It can be also printed on the thermal printer.
Page 172 Chapter 12 Printing Daily Report Printing Daily Report Today: Today's daily report is saved. Date: Daily report for the specified date is saved.  Touch [Enter] and specify the date, and then touch [ All: All the daily reports recorded in the device are saved. Touch [Save] or [Print].
Page 173: Chapter 13 Settings
Post-Load Examination Configure settings concerning examination methods and recording/ P13-26 printing content for post-exercise examination. Window Operation Procedure CAUTION  Contact Fukuda Denshi for more information on connecting and configuring the settings of ID readers. Touch [Menu] - [Settings]. 13-1...
Page 174: Ecg Control
Chapter 13 Settings ECG Control Touch the desired item to set. Change the settings.  Refer to the items below for information on the settings and setting values for each item.   For text entry method, refer to " "Character Entry"...
Page 175: General
Chapter 13 Settings ECG Control REFERENCE  The text in [] indicates the factory default setting.  Items with an asterisk (*) can be configured in the detailed settings window which will be displayed by pressing the [Details] key. General General Setup Item Description...
Page 176: Sensitivity
Chapter 13 Settings ECG Control Print Wave Thickness Specify the printing waveform thickness. Thin, [Normal], Thick, Very Thick Register Facility Name Register the hospital name to be printed on the recording paper. (30 characters) Time Unit Specify the time unit to be used for measurements printed on [sec.], ms recording paper.
Page 177: Printer Output
Chapter 13 Settings Patient Information General Process End Tone Specify the volume of the process end tone. 0 1 2 [3] 4 5 Volume Printer Output ECG Common Setup Item Description Setting Range Grid Specify whether to print grids. [No], Black, Color Wave Thickness Specify the printing waveform thickness.
Page 178: Patient
Chapter 13 Settings Patient Information Patient General Setup Item Description Setting Range Patient Reference Specify the source to refer the patient information. Master ID Ordering Media Work List [No] Clear after Exam. Specify whether to automatically delete the patient information Yes, [No] after saving the examination data to the specified media.
Page 179: Dept
Chapter 13 Settings Patient Information Setup Item Description Setting Range Entering Method Birthday: Entering the birthday will automatically calculate the age. [Birthday], Age Age: Enter the patient's age. Backup* Yes: Data is backed up. The content from before the power was Yes, [No], Daily turned off is called the next time the power is turned on.
Page 180: Medicine-Tech. Name
Chapter 13 Settings Patient Information Medicine-Tech. Name Medicine-Symptom Setup Item Description Setting Range <Medicine> Medicine-Enter Specify whether or not to enter medicine information. Yes, [No] No. of Digits Specify the number of digits of medicine codes. 2 to 4 [2 ] Regist Code Register a medicine code.
Page 181: File
Chapter 13 Settings File Doctor-Tech. Doctor 1, 2 Enter Specify whether or not to enter, display and print the doctor name. Yes, [No] No. of Digits Specify the number of digits of doctor codes. 2 to 12, [4] Regist Code Register doctor names (100 each).
Page 182: Storage Conditions
Chapter 13 Settings Communication Retrieve Setup Item Description Setting Range Media (Read) Specify the media to load the data. [SD card], USB1, USB2 DMS, Int. Memory Reanalyze Specify whether to reanalyze when a file is retrieved. Yes, [No] Display List* Set the display format for the file list.
Page 183: General
Chapter 13 Settings Communication General General Setup Item Description Setting Range Communication Specify whether to communicate with other devices. Yes, [No] Method Specify whether to use wired LAN or wireless LAN. [Wired LAN], Wireless LAN Retry Count on Timeout Specify the retry count when a timeout occurs during 0 to 5, [0] communication.
Page 184: Ordering
Chapter 13 Settings Communication Ordering General Setup Item Description Setting Range Operation mode Specify the operation mode for the ordering system. [No], Online No: Ordering function will not operate. Online: Ordering information will be obtained from the data management system (DMS). After Each Exam Select whether or not to display the order information list at the end [Yes], No...
Page 185: Shared Folder
Chapter 13 Settings Communication MWM Server Setup Item Description Setting Range MWM Server Specify the AE title of the MWM server. AE Title Up to 16 single-byte alphanumeric characters and symbols can be entered. MWM Server Specify the IP address of the MWM server. [0.0.0.0] IP Address MWM Server...
Page 186: External Device
Chapter 13 Settings External Device External Device ID Reader 1 and 2 Set the type, operations and data format of the ID reader. The settings for ID Reader 1, 2 will be also set for USB Port 1, 2 respectively. ID Reader Type 1, 2 Specify the type of ID reader.
Page 187: 12-Lead Examination
Chapter 13 Settings 12-Lead Examination 12-Lead Examination Set the items for 12-lead examinations. General General Setup Item Description Setting Range Check Lead-off Specify whether to stop recording if lead-off occurs during [Yes], No recording. Anonymous Specify whether or not to make patient information anonymous. Yes, [No] Bold Print Specify whether or not to print the patient information and...
Page 188: File
Chapter 13 Settings 12-Lead Examination Result Result Display Order Specify the initial setting of the result display. [Result], Waveform, Dominant, Detail Measurements Time Comparison Setup Item Description Setting Range Time Comparison Specify whether to perform time comparison. Yes, [No] Display Setup Item Description Setting Range...
Page 189 Chapter 13 Settings 12-Lead Examination General Save to Specify the media to save the data. [SD Card], USB1, USB2, DMS, Shar. Folder, DICOM At Analysis Error Specify whether to save results when error occurs. [Cancel], Continue Waveform Report Setup Item Description Setting Range Waveform Report...
Page 190: Freeze
Chapter 13 Settings 12-Lead Examination Results Report 1 Edit Abnormal wave* Specify whether or not to print abnormal waves such as Priority, [Standard] misplacing electrodes or recording failure. Print ST* Specify whether to print ST value on the upper right of the Yes, [No] dominant.
Page 191: Filter
Chapter 13 Settings 12-Lead Examination Filter General Setup Item Description Setting Range LP filter prop. Specify high frequency characteristics. 75 Hz, 100 Hz, [150 Hz], 250 Hz Drift Filter Specify drift removal filter characteristics. OFF, [Strong (0.5 Hz)], Weak (0.25 Muscle Filter Specify EMG filter characteristics.
Page 192 Chapter 13 Settings 12-Lead Examination Waveform Report Setup Item Description Setting Range Waveform Report Specify whether or not to output the waveform report. [Yes], No Rec. Range (Z-Fold) Specify the waveform recording duration. [1 sheet], 2 sheets Rec. Range (Roll) Specify the waveform recording duration.
Page 193 Chapter 13 Settings 12-Lead Examination Results Report 1 Edit Abnormal wave* Specify whether or not to print abnormal waves such as Priority, [Standard] misplacing electrodes or recording failure. Print ST* Specify whether to print ST value on the upper right of the Yes, [No] dominant.
Page 194: Extra Recording
Chapter 13 Settings 12-Lead Examination Printer Output/PDF1 Results Rep. Fmt. Specify the results report format. [DOM1], DOM2+Rhythm 1ch, DOM2+Rhythm 2ch, DOM3 FULL3+Rhythm 1ch, FULL3+Rhythm 2ch, FULL6 FULL6+Rhythm 1ch, Panorama Det. Meas.Report Specify whether or not to output the detailed measurements Yes, [No] report.
Page 195: Arrhythmia Ecg Examination
Chapter 13 Settings Arrhythmia ECG Examination Print Rhythm Measurement Meas. Report Specify whether or not to print the measurement report. [Yes], No Lines per page* Specify the number of lines per page. 6 lines, [8 lines] Arrhythmia ECG Examination Set the items for arrhythmia examinations. General General Setup Item...
Page 196: File
Chapter 13 Settings Arrhythmia ECG Examination File General Setup Item Description Setting Range Auto Save Specify whether to automatically save the examination data to the Yes, [No] media after the examination. Save to Specify the media to save the data. [SD Card], USB1, USB2, DMS, DICOM When meas.
Page 197: Rhythm Measurement
Chapter 13 Settings Rhythm Measurement Rhythm Measurement Configure items for rhythm measurements. General General Setup Item Description Setting Range Report ON/OFF Specify whether or not to print the report automatically. [Yes], No Lead Specify examination lead. I, [II], III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 Bold Print Specify whether or not to use bold print.
Page 198: Auto Printing
Chapter 13 Settings Post-Load Examination General Save to Specify the media to save the data. [SD card], USB1, USB2, DMS, DICOM When meas. error Specify whether to save measurement results when measurement [Cancel], Continue result error occurs. Auto Printing General Setup Item Description Setting Range...
Page 199: General
Chapter 13 Settings Post-Load Examination General Result Setup Item Description Setting Range Display Result Specify whether or not to display the measurement result after the automatic measurement. This is enabled only when resting. Before Wave Report, No: Measurement results are not displayed. [After Wave Report] Before Wave Report: The measurement results are displayed before printing the waveform report.
Page 200: Filter
Chapter 13 Settings Post-Load Examination Freeze Freeze Position Specify the default of the analysis position for displaying the First, Middle, [Last] freeze display. Filter There are 2 types of filter setting. [Filter 1] is for during resting, and [Filter 2] is for during exercise. General Setup Item Description...
Page 201 Chapter 13 Settings Post-Load Examination Waveform Report Wave. Type Continuous: Prints the waveform of each lead block as a [Continuous], continuous report, total time to be the specified time. Coherent (In-Phase), Coherent (In-Phase): Prints the waveform of each lead block with Coherent (Full) in-phase, total time to be the specified time.
Page 202 Chapter 13 Settings Post-Load Examination Results Report 2 Setup Item Description Setting Range Check Comment Specify whether to include the check comment. [Yes], No Edit Interpretation Specify the method for editing the interpretation section. [Judgment+Interp.] Judgment+Interp.: Interpretation is printed when general Interp.
Page 203: Post (Auto Print)
Chapter 13 Settings Post-Load Examination Printer Output/PDF2 Setup Item Description Setting Range Brugada Risk Report Specify whether or not to output the Brugada risk report. Yes, [No] Post (Auto Print) General Setup Item Description Setting Range Auto Sensitivity Specify the automatic sensitivity method. [Auto], 1+Auto, Auto+1, 1 + Auto: When a large waveform appears while recording with a Sensitivity1...
Page 204 Chapter 13 Settings Post-Load Examination Results Report 1 Results Rep. Fmt. Specify the results report format. [DOM1], DOM2+Rhythm 1ch, DOM2+Rhythm 2ch, DOM3 FULL3+Rhythm 1ch, FULL3+Rhythm 2ch, FULL6, FULL6+Rhythm 1ch, Cover, Panorama Time Comparison Analysis Report Specify the grade of findings to be output in the analysis report. Interpret., Interpret.: Prints analysis report for all interpretations.
Page 205: Post (Periodic Print)
Chapter 13 Settings Post-Load Examination Auto Extension Extension Conditions Specify the condition to perform auto extension. [Extension Code], Grade 6 Only, Grade 4 or higher, Grade 2 or higher, Extension Code Set the interpretation code to perform the extra recording when the [412, 413, 414, 415, 803, 804, 816, extension code is set.
Page 206 Chapter 13 Settings Post-Load Examination General Adjust Print Position Adjust the print position of the waveform. No, Centered, [Proportional] No: Adjustment is not performed. (0mV is the center) Centered: Adjusts the baseline to be the center. Proportional: Equalizes the blank space between each channel to avoid overlapping of the waveforms.
Page 207 Chapter 13 Settings Post-Load Examination Results Report 1 Commentary Report Specify the grade of findings to be output in the commentary Interpret., report. Auto, Interpret.: Prints commentary report for all interpretations. Grade 6 Only, Auto: Prints the report for high-grade interpretations. Grade 4 or higher, Grade 6 Only: Prints the report only for the grade 6.
Page 208: Post (Other)
Chapter 13 Settings Post-Load Examination Printer Output/PDF1 Setup Item Description Setting Range Waveform Report Specify whether or not to automatically print the waveform report. Yes, [No] Report Format Specify the report format. 3ch×4, 3ch×4+Rhythm 1ch, 3ch×4+Rhythm 2ch, [6ch×2], 6ch×2+Rhythm 1ch, 12ch (Vertical) Results Report Specify whether or not to automatically print the results report.
Page 209 Chapter 13 Settings Post-Load Examination Arrhythmia Printing Setup Item Description Setting Range Arrhythmia Lead Specify examination lead. [II, aVF, V5] I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 Waveform Report Specify whether or not to print the waveform report. [Yes], No Report Format Specify the waveform speed of the waveform report.
Page 210: Changing Functions Keys On The Examination Screen
Chapter 13 Settings Changing Functions Keys on the Examination Screen Changing Functions Keys on the Examination Screen Function keys in the 12-lead Examination window (Auto, Manual), Arrhythmia ECG window, and Rhythm Measurement window are sorted. Touch [Menu] - [Settings] - [Functions Key] . Touch the [Examination Name] tab to configure the settings and select the position of the function keys.
Page 211: Saving And Printing The Settings
Chapter 13 Settings Saving and Printing the Settings This allows to use the selected functions in each examination. REFERENCE  To restore the function keys to the default layout, touch [Reset] in the function key setting displays for each examination. Saving and Printing the Settings The current settings can be saved on a USB memory or printed on a recording paper.
Page 212 Chapter 13 Settings Saving and Printing the Settings 13-40...
Page 213: Chapter 14 Maintenance And Inspection
This chapter describes the maintenance and inspection procedures for this device. Make sure to perform daily checks and periodic checks to maintain functionality, performance and reliability. Please note that Fukuda Denshi shall not be liable for accidents arising from failure to perform maintenance and inspections.
Page 214: Periodic Check
Chapter 14 Maintenance and Inspection Periodic Check  Mechanical Check Check the device for mechanical failures while actually operating the device. Item Inspection Item Procedure Criteria Main Unit 1) Key Check that key operation is smooth. The operation should be smooth. 2) Printer Check that operation is smooth, and no The operation should be smooth and no...
Page 215: Periodic Check Procedure
Chapter 14 Maintenance and Inspection Periodic Check Periodic Check Procedure  Appearance Visually check the following items. Item Inspection Item Procedure Criteria Main Unit 1) Enclosure Check that there is no scratch, crack, Should be free of exterior flaws, cracks, deformation or rust on the main unit.
Page 216 Chapter 14 Maintenance and Inspection Periodic Check Item Inspection Item Procedure Criteria Performance 1) Check Date/Time Touch [Set Date/Time] on the maintenance Check that current date/time is displayed. menu screen. 2) Thermal Printing Test 1) Touch [Thermal Printing Test] on the The paper should not move in a zigzag maintenance menu screen.
Page 217: Electrical Safety Inspection Procedure
Chapter 14 Maintenance and Inspection Electrical Safety Inspection Procedure  Other Item Inspection Item Procedure Criteria Other 1) Power Supply Check that the power can be turned ON/ The power should turn ON/OFF both with OFF both with AC power and battery AC power and battery power.
Page 218: Safety Specification Of This Device
Chapter 14 Maintenance and Inspection Electrical Safety Inspection Procedure  Maximum allowable leakage current Leakage Current Type B Type BF Type CF (Unit: mA) Normal Single Normal Single Normal Single Condition Fault Condition Fault Condition Fault Condition Condition Condition Earth Leakage Current Touch Current Patient Leakage Current Direct...
Page 219: Touch Current
Chapter 14 Maintenance and Inspection Electrical Safety Inspection Procedure Touch Current 1. Measurement wiring diagram 2. Allowable value Normal Condition Single Fault Condition 0.1 mA 0.5 mA Patient Leakage Current (From Patient Connection to Ground) 1. Measurement wiring diagram Patient Applied Part (Patient Cable, CP-105J, etc.
Page 220: Patient Leakage Current (When External Voltage Is Applied To Patient Connection Of Type F Applied Part)
Chapter 14 Maintenance and Inspection Electrical Safety Inspection Procedure 2. Allowable value Normal Condition Single Fault Condition Direct Current 0.01 mA 0.05 mA Alternating Current 0.01 mA 0.05 mA Patient Leakage Current (When external voltage is applied to patient connection of Type F Applied Part) 1.
Page 221: Consumable Parts
Chapter 14 Maintenance and Inspection Consumable Parts Consumable Parts Replacement Period of Consumable Parts The following parts and accessories are consumable parts. The standard replacement time is as follows: The parts may need to be replaced earlier than the time described depending on operating environment. Any deterioration or abnormal condition is identified during operation or inspection, replace those parts immediately.
Page 222: Cleaning And Disinfection
Chapter 14 Maintenance and Inspection Cleaning and Disinfection CAUTION  Make sure to use the specified battery (BTE-002). Acid leakage, overheating or explosion may occur if a battery other than the specified battery is used.  Follow the precautions below when using the battery. Battery Life The battery can be charged and discharged (used) for approximately 300 times or within 1 year.
Page 223: Cleaning The Accessories
CAUTION  Never use sandpaper as it will damage the heating element.  Contact your Fukuda Denshi representative when the thermal print head requires cleaning.  Cleaning the Touch Panel Since the display panel uses a touch panel, finger prints and other stains are likely to appear.
Page 224: Correcting The Date And Time
Chapter 14 Maintenance and Inspection Correcting the Date and Time  Do not heat-disinfect the electrodes with water, steam or air.  Electrodes, Clip Electrodes  Wipe with a tightly squeezed cloth dampened with ethanol. Then, wipe off with dry cloth. ...
Page 225: Chapter 15 Appendix
Chapter 15 Appendix Specifications Chapter 15 Appendix Specifications The specifications of the device are as follows. REFERENCE  Specifications are subject to change without prior notice to improve the quality of products.  Operation Panel Power key, START/STOP key, Review key, Reset Key, 1 mV key, Lead key, Sensitivity key, custom keys, alphanumeric keys Standard Sensitivity 10 mm/mV...
Page 226 Chapter 15 Appendix Specifications USB port Compatible with USB2.0 Full Speed, 3 ports SD Card Compatible with SD Card Specification 2.0 Serial Port Compatible with RS-232C, 2 ports R-SYNC Port 5V output  Processing Unit Patient Information ID number, age, gender, height, weight, etc. Basic Measurement Heart rate, RR, PR, QRS, QT time, QTcB, QTcF, electrical axis, SV1, RV5 (6), TV1, Interpretations and Codes...
Page 227: Standard Items
Chapter 15 Appendix Standard Items  Transport Environment (Specified Products: Li-ion Battery Pack) Temperature -20°C to 35°C Humidity 45% to 85% (Non-condensing) Atmospheric Pressure 80 kPa to 106 kPa  Storage Environment (Specified Products: Li-ion Battery Pack) Temperature -20°C to 60°C (Within 30days) -20°C to 45°C (30days to 90days) -20°C to 35°C (90days to 1year) Humidity...
Page 228 Chapter 15 Appendix System Components  The Other Medical Devices The other medical devices to be used in combination with this device as a system are shown below. Item Model Type Quantity Remarks Patient Cable CP-105L-2038 Clip electrodes TE-43 1 set Adult (Contains: 4) Chest electrodes...
Page 229: Combination Example Of Medical And Non-Medical Equipments
Chapter 15 Appendix Combination Example of Medical and Non-Medical Equipments Combination Example of Medical and Non-Medical Equipments The general description of possible combination of different equipments in different medical environment as specified in IEC 60601-1 and ANSI AAMI / ES 60601-1, "Medical electrical equipment – Part 1: General requirements for basic safety and essential performance"...
Page 230: Check List
Chapter 15 Appendix Check List Check List  Daily Check List Remarks Item Inspection Item Procedure, Measurement, Criteria Judgment (Repair required) Appearance External 1 Exterior flaws, cracks, Check that flaws, cracks, deformation and OK/NG Appearance deformation, rust rust are not found on the main unit. 2 Peeling and dirt on label and panel Check that peeling or dirt is not found on OK/NG the label or the panel.
Page 231 Chapter 15 Appendix Check List  Periodic Check List Remarks Item Inspection Item Procedure, Measurement, Criteria Judgment (Repair required) Appearance External Exterior flaws, cracks, Check that flaws, cracks, deformation and OK/NG Appearance deformation, rust rust are not found on the main unit. Peeling and dirt on label and Check that peeling or dirt is not found on the OK/NG...
Page 232 Chapter 15 Appendix Check List Remarks Item Inspection Item Procedure, Measurement, Criteria Judgment (Repair required) Electrical Safety Earth Leakage Current Normal Condition 5 mA and below OK/NG Single Fault Condition 10 mA and below OK/NG Touch Current Normal Condition 0.1 mA and below OK/NG Single Fault Condition 0.5 mA and below...
Page 233: Glossary
Chapter 15 Appendix Glossary Glossary  Terms for Measurement Mode Basic Waveform Average of detailed waveform measurement Measurement Detailed Waveform Dominant waveform measurement of each lead Measurement Basic Arrhythmia Average of detailed arrhythmia measurement Measurement Detailed Arrhythmia Raw waveform (I, II, V2, V5) measurement of each heart rate Measurement ...
Page 234 Chapter 15 Appendix Glossary ST2 amplitude of detailed waveform measurement T1 amplitude of detailed waveform measurement T2 amplitude of detailed waveform measurement P1 duration of detailed waveform measurement P2 duration of detailed waveform measurement Q duration of detailed waveform measurement R duration of detailed waveform measurement S duration of detailed waveform measurement R' duration of detailed waveform measurement...

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Fx-8400

Fukuda CardiMax 4 Operation Manual

Chapter 1 General Description

Chapter 2 Installation

Chapter 3 Preparation before Examination

Chapter 4 Entering Patient Information

Chapter 5 12-Lead Examination

Chapter 6 12-Lead Examination (Advanced Function)

Chapter 7 Arrhythmia ECG Examination

Chapter 8 Rhythm Measurement

Chapter 9 File Transfers

Chapter 10 DICOM Work List

Chapter 11 Ordering System

Chapter 12 Printing Daily Report

Chapter 13 Settings

Chapter 14 Maintenance and Inspection

Chapter 15 Appendix

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