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Fukuda Denshi CardiMax8 Operation Manual

Fukuda Denshi CardiMax8 Operation Manual

Electrocardiograph

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Summary of Contents for Fukuda Denshi CardiMax8

  • Page 3 Contents Contents Preface Preface ............................i Contact ............................i About This Manual ........................i Expression Used in This Manual......................i Composition of This Manual........................ii Precautions for Using the Device Safely ................ii Safety Notations ..........................ii Example of Symbols........................... iii Labels for Assuring Safety ......................... iii Symbols on the Device........................
  • Page 4 Contents Character Entry..........................1-15 Chapter 2 Installation Precautions about the Installation Location ................ 2-1 Using the Battery Pack (Optional) ..................2-2 Precautions for Usage of Battery..................... 2-2 Charging the Battery........................2-3 Operating the Device on Battery Power ..................2-4 Checking the Remaining Battery Level.................... 2-4 Connecting the Cables .......................
  • Page 5 Contents Editing Patient Information ......................4-11 Deleting Unnecessary Patient Information ..................4-12 Using Patient Information of Examination Data Saved on Storage Media (Load Past Information)........................ 4-13 Anonymizing the Patient Information................4-14 Chapter 5 12-Lead Examination (Basic) Function Keys Used in Examinations ................. 5-2 Type of Waveform Recording: with FP-908A ..............
  • Page 6 Contents Saving to Different Storage Media....................5-36 Setting the Chest Leads ........................ 5-37 Changing the Chest Leads ......................5-39 Printing a Fixed Text on the Results Report .................. 5-40 Temporarily Changing the Report Format ..................5-41 Checking DMS Transmission ......................5-43 Chapter 6 12-Lead Examination (Advanced Function) Checking the Waveforms using the Freeze Function ............
  • Page 7 Contents Saving Quality Control Data ......................6-39 Quality Control Support Screen..................... 6-39 Setting Device No.......................... 6-41 Printing List Reports ........................6-41 Graph Report Printing ........................6-42 Saving Quality Control Data in CSV Format ................. 6-44 Setting Range for Various Measurement Values ................6-44 Saving Device Status Data in CSV Format ...................
  • Page 8 Contents Functions That Can Be Used After Analysis..................9-7 Automatically Recording Measurements: without FP-908A..........9-8 Preparation ............................9-8 To Start Recording........................... 9-9 Recording Examples........................9-11 Functions That Can Be Used After Measurement ................. 9-12 Correcting the Patient Information ....................9-13 Manual Recording......................
  • Page 9 Contents Loading............................11-6 Searching Data..........................11-8 Printing Reports..........................11-9 Printing Summary Reports ......................11-9 Printing the Data List ........................11-10 Deleting Examination Data ..................... 11-10 Deleting Data from the List......................11-10 Restoring Deleted Data ....................... 11-11 Editing Examination Data ....................11-12 Copying Examination Data .....................
  • Page 10 Contents Lead/Print ............................13-4 Sensitivity............................13-5 Custom Key ........................... 13-6 Display ............................13-6 Buzzer Control ..........................13-6 Localization............................ 13-7 Patient Information ......................13-8 Patient............................13-8 Department ..........................13-10 Medicine-Technician Name ......................13-11 Load DMS Settings........................13-12 File ..........................13-15 General ............................13-16 Save Conditions...........................
  • Page 11 Contents Rest (Auto Recording)......................... 13-53 Post-Exercise (Auto Recording) ....................13-56 Post-Exercise (Periodic Recording) .................... 13-57 Post-Exercise (Other)........................13-58 Extended Recording........................13-58 15-Lead Examinations....................13-59 General............................13-59 Freeze ............................13-61 Filter ............................13-62 15-Lead Manual Recording ......................13-62 15-Lead Auto Recording ......................13-65 15-Lead Review Recording ......................
  • Page 12 Contents Touch Current..........................14-8 Patient Leakage Current (from patient connection to earth)............14-8 Patient Leakage Current (when external voltage is applied to the patient connecting part of the Type F applied part)........................... 14-8 Patient Auxiliary Current ........................ 14-9 Consumable Parts ......................14-9 Consumable Part Replacement Schedule..................
  • Page 13 Components are used in accordance with Fukuda Denshi operating instructions. 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 14 Preface Precautions for Using the Device Safely The messages displayed on the screen are enclosed in the following symbols < >. (Ex.: <Acquiring waveforms>, etc.) Composition of This Manual This operation manual is composed of the following chapters. Chapter Title Description Preface General Description, Precautions for Safety, Displayed Messages and Countermeasures...
  • Page 15 Preface Precautions for Using the Device Safely Read the following information thoroughly to ensure proper, correct and safe use of this device. Indicates a potentially hazardous situation which, if not avoided, will result in death, serious injury, or DANGER fire. Indicates a potentially hazardous situation which, if not avoided, could result in death, serious injury, WARNING or fire.
  • Page 16 Preface Precautions for Using the Device Safely Symbols on the Device The following is a list of symbols used on this device. Failure to follow operating instructions could place the patient or operator at risk. Indicates the need to refer to the related accompanying documents before operation. Indicates a matter of Danger, Warning that calls attention for safety.
  • Page 17 Preface Precautions for Using the Device Safely 7 Classification according to the degree of safety when using in the presence of air or flammable anesthetic gas or oxygen or nitrous oxide and flammable anesthetic gas. To be used in environments without flammable anesthetic gas or other flammable substances 8 Target Child, Adult ...
  • Page 18 The leakage current and increase in protective earth impedance may cause electric shock and overheating. Optional Accessories WARNING  Use only the cables specified by Fukuda Denshi. Use of other cables may result in increase in emission or decrease in immunity. Application to Heart CAUTION ...
  • Page 19  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 20 Preface Precautions for Using the Device Safely  Do not allow the patient to come in contact with this device, other electrical devices or surfaces such as metal. This increases current leakage, which may result in danger to the patient. ...
  • Page 21 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 are caused by using unspecified items.
  • Page 22 Preface Precautions for Using the Device Safely  Due to the characteristics of radio waves, the communication range and communication speed vary depending on the installation location and operating environment. Precautions for Using the Wireless LAN with Other Devices CAUTION ...
  • Page 23 Preface Precautions for Using the Device Safely volatile organic solvents, oil-containing cleaners, or sharp-edged tools. It may damage the surface resin coating, resulting in discoloration, scratches, malfunction, and deterioration.  For the precautions for storing and handling the chemicals, refer to the instruction manual for the respective chemical.
  • Page 24 Preface Precautions for Using the Device Safely interpretation may not match the diagnosis of the doctor reading the ECG. When making a final diagnosis, doctors should take an overall view that includes the patient's general state and other examinations (biochemical examinations, X-rays, Holter ECG, stress, lung function, etc.) Precautions Concerning Automatic Analysis of ECG CAUTION...
  • Page 25 Preface Precautions for Using the Device Safely If the patient is moving or talking, instruct them to stop. Instruct the patient to hold their breath briefly while recording the ECG. Caused by the Electrodes When clip electrodes or chest electrodes are applied, clean the electrodes with alcohol or soapy water. For stubborn stain, rub with sandpaper.
  • Page 26 Preface Precautions for Using 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 27 Preface Precautions for Using the Device Safely Immunity Test Test Level Compliance Level Electromagnetic Environment/ Guidance Radiated RF EM Fields 3 V/m 3 V/m The portable RF communications IEC 61000-4-3 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz equipment (including antenna cable 80% AM (2 Hz) 80% AM (2 Hz)
  • Page 28 Preface Precautions for Using the Device Safely Test Band Service Modulation Maximum Distance Test Level Frequency (MHz) Power (V/m) (V/m) (MHz) Immunity test 380 to 390 TETRA 400 specifications for 18 Hz RF wireless 430 to 470 GMRS 460 communications FRS 460 ±5kHz equipment...
  • Page 29 Messages and Countermeasures 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 30 If the situation does not improve even after performing the above measures, device failure can be considered. Contact a Fukuda Denshi service representative. When using the waveform simulator, check if the output waveform is displayed as baseline.
  • Page 31 <Failed to delete data.> Failed to delete ECG data. The failure of the media can be considered. Contact your local Fukuda Denshi service representative. <No data selected.> A process was performed without selecting Select a data before performing the process.
  • Page 32 When this message is displayed, the data is Management System). not sent to the DMS (Data Management System). Contact your local Fukuda Denshi service representative. <Failed to retrieve patient No corresponding patient information was Check that the entered ID is correct, or the information.>...
  • Page 33 Preface Messages and Countermeasures Wireless Patient Module (WPM) Message Cause Solution Failed to connect to WPM. Failed to connect to WPM. Confirm the following: [Reconnect] [Ach] [Bch] WPM is turned on. WPM is connecting. Missing waveform data was not Filed to get complementary data. Check the communication environment.
  • Page 34 Preface Messages and Countermeasures xxii...
  • Page 35 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-9800. Features of this ECG The CardiMax series FX-9800 system measures and prints a standard 12-lead electrocardiogram (ECG) with high accuracy.
  • Page 36 Chapter 1 General Description Features of this ECG  Intended Patient The Intended patient of this product is as follows.  Patients/examinee who needs electrocardiogram examination  Adults  Adolescents (age of 12 to 18 years old)  Children (age of 2 to 11 years old) *Patient who can attach the electrodes without shorting.
  • Page 37 Chapter 1 General Description Features of this ECG By adopting a high-density thermal printing method, clear ECG waveforms can be printed on a 210 mm wide recording paper. Furthermore, patient information and ECG analysis can be printed at the same time. ...
  • Page 38 This section describes parts and their functions of this device. WARNING  Contact your local Fukuda Denshi service representative when connecting with other devic- Otherwise, it may cause hazardous situation such as electric shock to the patient and oper- ator.
  • Page 39 Chapter 1 General Description Names of Parts and Their Functions  Front View  Rear View, Bottom View 1 Operation Panel Keys for starting the ECG recording, custom keys, etc. are located. 2 AC Power Indicator (Blue) When connected to an AC outlet, the indicator will light. 3 Charge Indicator (Blue/Orange) During charging, it will light in blue.
  • Page 40 Chapter 1 General Description Names of Parts and Their Functions NOTE  Do not remove the SD card or USB memory or turn OFF the device during operation of the SD card or USB memory. 8 Vents Used as air inlets and outlets. NOTE ...
  • Page 41 Chapter 1 General Description Names of Parts and Their Functions  LCD Monitor 1 LCD Monitor  Displays ECG waveforms and patient information ( "How to View the LCD" P1-9). NOTE  Although the color LCD utilizes highly advanced technologies, occasionally, there may be a few pixels which do not light (dots) or constantly light.
  • Page 42 Chapter 1 General Description Types and Functions of Operation Panel Keys Types and Functions of Operation Panel Keys The operation panel keys are used for operation. The function of each key on the operation panel is as follows. 1 Power Supply Key Turns the power ON/OFF.
  • Page 43 Chapter 1 General Description How to View the LCD 10 Start/Stop Key Starts/stops the recording. When pressed during recording, recording will stop. 11 Review Key Starts/stops the review recording during an ECG examination. 12 Freeze Key  Past waveform can be checked. ( "Checking the Waveforms using the Freeze Function"...
  • Page 44 Chapter 1 General Description How to View the LCD 3 [Examination] key/Examination Status Message The currently selected examination is displayed. Touching this button displays the "Select Examination" window for selecting an examination. 4 [Filter] key The currently selected filter is displayed. Touch this to display the filter setting window. 5 Examination mode display area Displays the auto/manual mode status and recording sensitivity.
  • Page 45 Chapter 1 General Description How to View the LCD  List of Icons Item Icon Description Item Icon Description Electrode Lead off/electrode misattached/ SD Card SD Card Connection Error noise Normal SD Card Connection Remaining Capacity of Saving Data: 500 and above Limb electrodes attached incorrectly SD Card Connection Remaining Capacity of...
  • Page 46 Chapter 1 General Description Basic Operation Procedure  Icons Displayed in Other Windows Display Area Icon Description Display Area Icon Description During file USB1 Message Caution operations Display USB2 Warning SD Card Examination Lead off base Window Lead off electrode: RA (icon color: white) Shared Folder Lead off electrode: RL (icon...
  • Page 47 Chapter 1 General Description Basic Operation Procedure The touch key will respond by pressing any part of the key. Flick Operation Flick left or right on the screen (slide your finger quickly across the screen) to switch display screens. For example, when the analysis result window is displayed, the window can be changed to the detailed mea- surement window or dominant waveform window by flicking on the screen.
  • Page 48 Chapter 1 General Description Basic Operation Procedure  More detailed setup items are displayed.  Common operation in the windows ・[×]: Closes window ・ [Clear]: All entered numbers will be cleared. ・[ ]: The entered content will be set. Changing the Examination Type Touch [Exam.].
  • Page 49 Chapter 1 General Description Basic Operation Procedure Displaying the Menu Touch [Menu]. Touch the desired item. Character Entry  Entering Numbers Use the numeric keys to enter the patient's height, weight, and ID number. Enter the desired number using the numeric keys. ...
  • Page 50 Chapter 1 General Description Basic Operation Procedure Enter alphanumeric characters or symbols. Touch the characters to be entered.  [A → a] [a → A]: Switches between uppercase and lowercase characters when alphanumeric charac- ters are entered.  [Alphanum.]: Switches to alphanumeric characters. ...
  • Page 51 Chapter 2 Installation Precautions about the Installation Location Chapter 2 Installation This section describes ECG installation, cable connection, power ON/OFF, and paper replacement procedures. Precautions about the Installation Location 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 52 Chapter 2 Installation Using the Battery Pack (Optional) Using the Battery Pack (Optional) This section explains how to install and charge the optional battery pack. DANGER  To avoid overheating, combustion, explosion, or acid leakage, follow these rules: ・ Throwing the battery pack into fire, heating, disassembly and remodeling are strictly prohibited.
  • Page 53 Chapter 2 Installation Using the Battery Pack (Optional)  Grid Printing To perform grid printing with “Roll paper” or “Z-fold paper”, large amount of battery power is required. Consequently, the voltage drops and the recordable duration becomes very short. If performing grid printing, it is recommended to use the AC power.
  • Page 54 Chapter 2 Installation Using the Battery Pack (Optional)  When the battery temperature is 5°C and below or 50°C and above, the battery does not charge. Operating the Device on Battery Power Turn ON the device by pressing the (POWER) key on the operation panel with the power cable unplugged. ...
  • Page 55 Chapter 2 Installation Connecting the Cables  <Battery is running low. Please recharge the battery.>  <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.> ...
  • Page 56 Chapter 2 Installation Connecting the Cables  When the power cable is connected, the charge indicator will light for a short time (ap- prox. 0.5 sec.) to indicate that the device is activated.  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 equipotential line.
  • Page 57 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 blue. Press the (Power) key on the operation panel.  Check that a beep sounds when the key is pressed. ...
  • Page 58 Chapter 2 Installation Turning ON/OFF the Power To Login If the login function is set, a login display appears when the power is turned ON, or when resuming from sleep mode. NOTE  To use the login function, it is necessary to perform the setup and user registration in ...
  • Page 59 Chapter 2 Installation Loading the Recording Paper Sleep Mode This device has a sleep mode function. A quick activation of the device is possible by using a sleep mode. The procedure to enter sleep mode is the same as turning OFF the power. NOTE ...
  • Page 60 Chapter 2 Installation Loading the Recording Paper Insert the paper into the paper slot from the bottom side and pull it upwards. Hold the edges of the Z-fold paper, and pull it out approximately 20 cm. 2-10...
  • Page 61 Chapter 2 Installation Loading the Recording Paper Close the paper tray. Press down the paper tray cover until a clicking sound is heard.  Specify the type of recording paper to be used. ( "ECG Control" P13-3) Turn ON the power. Touch [Menu] - [Setting] - [ECG Control] - [Lead/Print] - [Printing].
  • Page 62 Chapter 2 Installation Loading the Recording Paper  To Set the Roll Paper Press the button to open the paper tray cover. Button Paper Tray Cover NOTE  When opening the paper tray cover, the display should be facing front. Insert the roll paper, aligning the shaft hole of the roll paper with the protrusion on the far side.
  • Page 63 Chapter 2 Installation Loading the Recording Paper Insert the shaft hole of the roll paper into the protrusion on nearer side, while pressing down the protrusion on the far side.  Check that the protrusion is properly inserted into shaft hole of the roll paper. Hold the edges of the paper, and pull it out approximately 20 cm.
  • Page 64 CAUTION  Configure and connect to the network as specified by Fukuda Denshi.  Use the Ethernet hub recommended by Fukuda Denshi (compliant with IEC 60950-1, IEC 62368-1, and equivalent standard with CISPR 32 / CISPR 24 or VCCI).  Devices connected to the network, such as Ethernet hub and PC, need to be installed 1.5...
  • Page 65 Select the host to be used REFERENCE  Consult the network administrator to confirm the IP addresses (e.g. 192.168.0.3) and port numbers that can be assigned to the device and computer.  Contact Fukuda Denshi for more information on configuring the wireless LAN settings. 2-15...
  • Page 66 Chapter 2 Installation Connecting to the Network 2-16...
  • Page 67 Chapter 3 Preparing for an Examination Attaching Electrodes Chapter 3 Preparing for an Examination This chapter explains how to attach electrodes, handle external media, and set filters.  "Using the Wireless Patient Module" P6-46 for an explanation of how to prepare the Wireless Patient Module before an examination.
  • Page 68 Chapter 3 Preparing for an Examination Attaching Electrodes How to Attach  Attaching Electrodes: Limbs (Four Locations) ・When Using "Niprode III" Attach to the position while ensuring that the tab (ear part) faces the lead cable side. Stick the electrode by tracing with the finger.
  • Page 69 Chapter 3 Preparing for an Examination Attaching Electrodes Using the included electrodes can increase the ECG recovery time after defibrillator discharge.  Attaching Electrodes: Chest (Six Locations + Three Optional Locations): 15-Lead Examination Attach the electrodes to the following positions. Ensure that the patient feels no pain. 1) Fourth intercostal space at right sternal border 2) Fourth intercostal space at left sternal border 3) On the conjugate midpoint directly between 2) and 4)
  • Page 70 Chapter 3 Preparing for an Examination Confirming Time and Date Confirming Time and Date Confirm the time and date shown in the lower right corner of the home screen.  If they are not correct, change them by referring to "Modifying the Time and Date"...
  • Page 71 Chapter 3 Preparing for an Examination Setting Sensitivity Set the filters. Touch the filter corresponding to the noise.  The touched filter will turn ON or OFF. To set details, touch [Details]. The detailed settings window will appear.  For each filter, select the filter strength or turn OFF the filter. Touch [×] or [Back] to exit settings.
  • Page 72 Chapter 3 Preparing for an Examination Switching Patients  Each time the key is pressed, the selection will change in the order of AUTO → ×1 → ×1/2 → ×1/4 → ×2 → AUTO → ... (cm/mV).  If AUTO is selected, then the optimal sensitivity for display and printing will be automatically set to either 1 cm/mV, 1/2 cm/mV, or 1/4 cm/mV.
  • Page 73 Chapter 3 Preparing for an Examination Final Check  Are the lead cables connected correctly?  Are the supplied lead cables being used? Make sure to use the supplied lead cables.  Is the plug secure?  Are they located far enough from the power cable? ...
  • Page 74 Chapter 3 Preparing for an Examination Final Check...
  • Page 75 Chapter 4 Entering Patient Information Chapter 4 Entering Patient Information Enter the patient information, including name, age, gender, and so on. There are following 5 methods to enter the information. 1 Entering manually (Name, height, weight, medicine, and other items can be entered.) ...
  • Page 76 Chapter 4 Entering Patient Information Categories of Entered Information Categories of Entered Information The following information can be entered. Display Description Setting Range Supplementary Information Name Patient number 3 to 20 characters Alphanumeric characters can be entered Sub ID Sub patient number 3 to 20 characters Alphanumeric characters can be entered Up to two items can be entered into...
  • Page 77 Chapter 4 Entering Patient Information Entering Detailed Information Entering Detailed Information  For text entry method, refer to " "Entering Text" P1-15". REFERENCE  Set this to "Extended" in advance in [Setting]: [Patient Information] - [Patient] - [General] - [ID]. ...
  • Page 78 Chapter 4 Entering Patient Information Entering Detailed Information [Patient] - [ID]. Enter the sub ID number. REFERENCE  To enter the sub ID, set [Patient Information] - [Patient] - [Sub ID 1, 2] - [ID Entry] to "Yes." Enter the birth date. Touch the numeric keys to enter the year of birth.
  • Page 79 Chapter 4 Entering Patient Information Entering Detailed Information Enter the name.  For text entry method, refer to " "Character Entry" P1-15". Select the department. Touch the corresponding department classification (Dept 1 to 4). To enter a department code, touch [Enter Code] and then input the code using the numeric keys. ...
  • Page 80 Chapter 4 Entering Patient Information Entering Detailed Information Enter medications. Select the corresponding medicine and touch [Change] to change the code and medication name. (Medications with numbers 1 to 10 cannot be changed.) Enter symptoms. Select the corresponding symptom and touch [Change] to change the code and symptom name. (Symptoms with numbers 1 to 10 cannot be changed.) Enter a comment.
  • Page 81 Chapter 4 Entering Patient Information Entering Detailed Information Enter the body position. Enter the respiration rate. Enter the pacemaker information. Enter the doctor and technician names. Select the corresponding number and touch [Change] to change the code as well as the doctor and technician names.
  • Page 82 Chapter 4 Entering Patient Information Using Patient Information Saved on an SD Card (Media) Confirm the entered details on the patient information setting screen, then touch [  The display will return to the home display.  The entered information will be displayed in the patient information display area.
  • Page 83 Chapter 4 Entering Patient Information Using Patient Information Saved on an SD Card (Media) Registering Patient Information Enter patient information, conduct examinations, and register that patient information on an SD card. Insert a formatted SD card into the SD card slot. Enter the patient information and conduct the examination.
  • Page 84 Chapter 4 Entering Patient Information Using Patient Information Saved on an SD Card (Media) Enter the ID number. Touch  The entered ID is reflected in the patient information setting window.  The patient information is loaded from the SD card based on the entered ID.
  • Page 85 Chapter 4 Entering Patient Information Using Patient Information Saved on an SD Card (Media) Searching for Patient Information Search for patient information matching specific conditions in the registered patient information list. Touch [Search] on the patient information list.  The search condition window will appear. Specify the search conditions (ID/name/examination date).
  • Page 86 Chapter 4 Entering Patient Information Using Patient Information Saved on an SD Card (Media) Deleting Unnecessary Patient Information Delete patient information that is no longer necessary from an SD card. Touch [Delete] in the patient information list.  A confirmation window for switching to the deletion screen will be displayed. Touch [Yes] to switch screens.
  • Page 87 Chapter 4 Entering Patient Information Using Patient Information of Examination Data Saved on Storage Media (Load Past Information) Using Patient Information of Examination Data Saved on Storage Media (Load Past Information) It is possible to retrieve and use examination data on storage media during the next examination. To use this function, set [Setting]-[Patient Information]-[Patient]-[General]-[Patient Reference] to "Load past information."...
  • Page 88 Chapter 4 Entering Patient Information Anonymizing the Patient Information Anonymizing the Patient Information The patient information entered on the screen or in a report can be made anonymous. Touch [Setting] on the menu. Touch the examination to make anonymous. (For example, 12-Lead examination.) Set “Anonymous”.
  • Page 89 Chapter 4 Entering Patient Information Anonymizing the Patient Information  Display Only: Anonymizes the patient on the examination screen. (Other than ID.)  Both: Anonymizes the patient on reports and examination screen.  None: Does not make patient information anonymous. REFERENCE ...
  • Page 90 Chapter 4 Entering Patient Information Anonymizing the Patient Information 4-16...
  • Page 91 Chapter 5 12-Lead Examination (Basic) Chapter 5 12-Lead Examination (Basic) The basic process for conducting a standard ECG examinations is as follows. NOTE  The analysis function can be used only if the FP-908A optional software is installed. In this manual, the explanation of function is distinguished as follows. “with FP-908A”: The explanation when analysis function is used.
  • Page 92 Chapter 5 12-Lead Examination (Basic) Function Keys Used in Examinations Function Keys Used in Examinations The function keys vary depending on the operating mode. REFERENCE   The sort order varies if the auto capture function is set to "Yes". See "Auto Capture Function"...
  • Page 93 Chapter 5 12-Lead Examination (Basic) Type of Waveform Recording: with FP-908A  Manual Mode (while printing) 25mm/s  While recording compressed waveform *1: Displayed only when “Time Comparison” is set to “Yes”. *2: During standard mode, data saving is carried out according to the DMS settings. *3: During offline mode, the operation is performed if a connection to the network is not made.
  • Page 94 Chapter 5 12-Lead Examination (Basic) Type of Waveform Recording: without FP-908A REFERENCE  The Brugada Risk Analysis Report is output only if “Setting > 12-Lead > 12-Lead Auto Record >Brugada Analysis Report” is set to "Yes" and a Brugada analysis result is detected. ...
  • Page 95 Chapter 5 12-Lead Examination (Basic) Analyzing and Recording Waveforms Automatically: with FP-908A  Selection of Display Type In the function key area, touch [Change Display] to select the display type. if [Change Display] is touched, the display switches in the order of "6ch×2 + Rhythm" → "6ch×2" → "Display 1" → "Display 2"...
  • Page 96 Chapter 5 12-Lead Examination (Basic) Analyzing and Recording Waveforms Automatically: with FP-908A Select "Auto" for recording.  The default setting is "Auto".  Touch [Auto/Manual] to switch between auto recording and manual recording.  When "Auto" is set: The leads will be normally displayed. When "Manual"...
  • Page 97 Chapter 5 12-Lead Examination (Basic) Analyzing and Recording Waveforms Automatically: with FP-908A  Check the current waveforms shown in the display. Press the ◀ and ▶ keys to switch the leads.   When the waveforms of 6 channels/3 channels are displayed, the displayed leads will change. Press the (START/STOP) key on the operation panel to start acquiring waveforms.
  • Page 98 Chapter 5 12-Lead Examination (Basic) Analyzing and Recording Waveforms Automatically: with FP-908A Recording Examples ● Auto Recording (Directly Written Recording) The example of the following is shown: Waveform Report: 3chx4 + Rhythm 1ch Waveform Acquiring Time: 10 seconds Calibration Position: Beginning Rhythm Lead: Lead II ●...
  • Page 99 Chapter 5 12-Lead Examination (Basic) Analyzing and Recording Waveforms Automatically: with FP-908A ● Auto Recording (Results Report) The example of the following is shown: Result Report: DOM3 Interpretation Section: General Interpretation + Interpretation Name Comment Section: Comment Measurement Section: Measurement + Minnesota Code Analysis Section: Analysis Result NOTE...
  • Page 100 Chapter 5 12-Lead Examination (Basic) Analyzing and Recording Waveforms Automatically: with FP-908A ● Analysis Report The following setting is required. Set "Interpretation" for “Analysis Report” under [Setting] - [12-Lead] - [12-Lead Auto Record] - [Results Report 1]. ● Brugada Risk Analysis Report The following setting is required.
  • Page 101 Chapter 5 12-Lead Examination (Basic) Analyzing and Recording Waveforms Automatically: with FP-908A ● Synthesized 18-Lead Report The following setting is required. Select "Yes" under [Setting] - [12-Lead] - [General] - [ACS Diagnostic Aid] - [ACS Diagnostic Aid Function]. Select "Right-sided Leads (V3R, V4R, V5R)" and "Posterior Leads (V7, V8, V9)"...
  • Page 102 Chapter 5 12-Lead Examination (Basic) Analyzing and Recording Waveforms Automatically: with FP-908A ● [Display] selection ● Measured Waveform The analysis result display can be selected. Measured waveform can be verified. ● [Analysis Result] ● [All Waveforms] The analysis result will be displayed. The analysis report of All waveforms can be verified.
  • Page 103 Chapter 5 12-Lead Examination (Basic) Automatically Recording Measurements: without FP-908A ● [Time Series] ● [Save] The time comparison analysis result will be displayed. The media selection window will be displayed. Select the Depending on the settings, comparison with the media to save the data. interpretations of past data can be performed.
  • Page 104 Chapter 5 12-Lead Examination (Basic) Automatically Recording Measurements: without FP-908A Preparation  Settings for 12-Lead Auto Recording  Perform settings under [Setting] > [12-Lead] > [12-Lead Auto Record] in advance.( "12-Lead Examinations" P13- 25).  Selection of Display Type In the function key area, touch [Change Display] to select the display type. When [Change Display] is touched, the display switches in the order of "6ch×2 + Rhythm"...
  • Page 105 Chapter 5 12-Lead Examination (Basic) Automatically Recording Measurements: without FP-908A  Enter the patient information. ( Chapter 4 "Entering Patient Information")  Attach the ECG electrodes and check that ECG waveforms appear on the display. ( "Attaching Electrodes" P3-1) Select "Auto" for recording. ...
  • Page 106 Chapter 5 12-Lead Examination (Basic) Automatically Recording Measurements: without FP-908A When "Manual" is set: The leads to be recorded will be highlighted (white text on a black background). Auto Manual Check the ECG waveforms.  Check the current waveforms shown in the display. Press the ◀...
  • Page 107 Chapter 5 12-Lead Examination (Basic) Automatically Recording Measurements: without FP-908A REFERENCE   Refer to "Functions That Can Be Used After Analysis" P5-11 for operation of the measurement result display. Recording Examples ● Auto Recording (Directly Written Recording) The example of the following is shown: Waveform Report: 3chx4 + Rhythm 1ch Waveform Acquiring Time: 10 seconds Calibration Position: Beginning...
  • Page 108 Chapter 5 12-Lead Examination (Basic) Automatically Recording Measurements: without FP-908A ● Auto Recording (Results Report) The example of the following is shown: Result Report: Cover ● Detailed Measurement Report The following setting is required. Set "Yes" for “Det. Meas. Report” under [Setting] - [12-Lead Exam.] - [12-Lead Auto Record] - [Result Report].
  • Page 109 Chapter 5 12-Lead Examination (Basic) Automatically Recording Measurements: without FP-908A ● Synthesized 21-Lead Report The following setting is required. Select [Setting] - [12-Lead] - [General] - [Lead] - [Synthesized Lead] with "Right-sided Leads (V3R, V4R, V5R)," "Posterior Leads (V7, V8, V9)," "High Intercostal Lead".
  • Page 110 Chapter 5 12-Lead Examination (Basic) Automatically Recording Measurements: without FP-908A ● [Detailed Value] ● [Time Comparison Result Window] Detailed measurements will be displayed. The time comparison result will be displayed. Depending on the settings, comparison with the past data can be performed. ●...
  • Page 111 Chapter 5 12-Lead Examination (Basic) Manual Recording Manual Recording ECG can be recorded by manually changing lead and sensitivity. Starting Manual Recording Touch [Exam.]. Touch [12-Lead].  When power is turned on, the examination screen set in [Register Examination > On Start-up] is displayed. ...
  • Page 112 Chapter 5 12-Lead Examination (Basic) Manual Recording  Touch [Auto/Manual] to switch between auto recording and manual recording.  When "Auto" is set: The leads will be displayed as usual. When "Manual" is set: The leads to be recorded will be highlighted (white text on a black background). Auto Manual Check the ECG waveforms.
  • Page 113 Chapter 5 12-Lead Examination (Basic) Manual Recording By pressing the ◀ / ▶ keys, the lead block will change in the order of "Block 1"  "Block 2" …"STD" "Block 1", and so forth. The lead type of the waveform to be recorded is highlighted. Lead Mode 12-lead Channels...
  • Page 114 Chapter 5 12-Lead Examination (Basic) Manual Recording Without FP-908A REFERENCE  To analyze the manually recorded waveforms, select “Yes” for “Measurement” under [Setting] - [12-Lead] - [12L Manual Rec.] - [General]. When the system is ready for waveform measurement, "Meas. OK" will be displayed. Recording and Saving Full Disclosure Waveforms in Manual Recording Mode ...
  • Page 115 Chapter 5 12-Lead Examination (Basic) Manual Recording  Recording and Saving Full Disclosure Waveforms Touch the [Auto/Manual] key on the 12-lead examination screen to switch to manual mode. Press the (START/STOP) key on the operation panel to start recording waveforms. Press the (START/STOP) key on the operation panel again to stop recording waveforms.
  • Page 116 Chapter 5 12-Lead Examination (Basic) Recording Waveforms from Several Seconds Before (Review) ● Manual Recording (12ch) The example of the following is shown: Lead: Limb, Chest Recording Waveforms from Several Seconds Before (Review) Review Recording System Usually, waveforms are printed by pressing the (START/STOP) key on the operation panel, which prints the ECG for the specified period of time from the time the key was pressed.
  • Page 117 Chapter 5 12-Lead Examination (Basic) Displaying and Printing Commentary: with FP-908A  The operations after this are the same as those for auto recording. ( "Analyzing and Recording Waveforms Automatically: with FP-908A" P5-4) Displaying and Printing Commentary: with FP-908A Setting Result Display and Report Touch [Menu] - [Setting] - [12-Lead] - [General] - [Display].
  • Page 118 Chapter 5 12-Lead Examination (Basic) Displaying and Printing Commentary: with FP-908A  [Auto]: Only prints one interpretation from the high-grade interpretations automatically determined by this device.  [Grade 6 Only]: Only prints if the interpretation is grade 6.  [≥ Grade 4]: Only prints if the interpretation is grade 4 or above. ...
  • Page 119 Chapter 5 12-Lead Examination (Basic) Extend Recording  The Analysis Report will be printed. Recording Examples ● Analysis Report Extend Recording Auto Extension REFERENCE  To extend recording automatically, set "Yes" under [Setting] - [12-Lead] - [12-Lead Auto Record] - [Auto Extend] - [Auto Extend Recording]. REFERENCE ...
  • Page 120 Chapter 5 12-Lead Examination (Basic) Extend Recording Manual Extension Recording can be manually extended for a desired length of time. Touch [Extend Recording]. To stop recording, press the (START/STOP) key. REFERENCE  The waveforms are analyzed and saved from the start to the end time of extended recording.
  • Page 121 Chapter 5 12-Lead Examination (Basic) Using the Guide Function ● Extended Recording (Results Report) Using the Guide Function This device provides "Guide Windows" that can guide the user's operations during an ECG examination. A guide window displays the examination procedure sequentially. It can be selected from the following four patterns. 1 Patient (patient information entry) →...
  • Page 122 Chapter 5 12-Lead Examination (Basic) Using the Guide Function Guide Windows This section describes the guide windows displayed by the guide function. ● Operations Common to All Guide Windows [×]: Closes the guide window. To show the guide window again, touch the [g] button in the upper right corner of the screen.
  • Page 123 Chapter 5 12-Lead Examination (Basic) Noise Level Display Function ● Freeze Record Guide Displayed at the timing when freeze recording occurs. Touch [Freeze] to start freeze recording. For details regarding freeze recording, refer to  " "Checking the Waveforms using the Freeze Function"...
  • Page 124 Chapter 5 12-Lead Examination (Basic) Auto Filter Function The larger the value of the noise level, the more noise is mixed in. Small Noise Interference Large REFERENCE  The following setting can be used to show/hide the noise level. [Menu] - [Setting] - [12-Lead] - [General]>[Artifact Detection]>[Noise]>[Noise Level Display] Auto Filter Function The auto filter function automatically turns a filter on when the noise level exceeds a certain threshold.
  • Page 125 Chapter 5 12-Lead Examination (Basic) Other Functions Other Functions Printing Marks When the Mark/Feed key is pressed during recording, a mark is printed on the recording paper. Marks are printed for the number of times the key is pressed. Keep pressing down [Mark] to print the marks continuously.
  • Page 126 Chapter 5 12-Lead Examination (Basic) Other Functions Continuously Recording the Same Lead The same lead can be continuously recorded using Auto Recording. Touch [Hold] during recording.  The same lead is continuously recorded.  It is also possible to assign [Hold] to a custom key. Touch [Cancel Hold] to end recording.
  • Page 127 Chapter 5 12-Lead Examination (Basic) Other Functions Touch the [Save] function key. Select the media to save data. REFERENCE  By assigning [Save] to custom key, it is possible to save data to all media selected on the media selection window. Setting the Chest Leads Under [12-Lead] - [General] - [Lead] - [Chest Lead], V1 to V9, V1R to V9R leads can be assigned to electrode V1 to V6.
  • Page 128 Chapter 5 12-Lead Examination (Basic) Other Functions Touch [General] - [Lead]. Touch either one of the leads from 1 to 4. On the displayed window, assign the lead for V1 to V6. Touch [ ← ], [ → ] to select the lead to be changed. The selected lead will be displayed in blue.
  • Page 129 Chapter 5 12-Lead Examination (Basic) Other Functions After selecting the lead, touch [ Touch [Enter]. Changing the Chest Leads The leads for V1R, V2R, V3R, V4R, V5R, V6R, V7R, V8R, V9R, V7, V8, and V9 can be specified. Touch [Change Chest Lead]. 5-39...
  • Page 130 Chapter 5 12-Lead Examination (Basic) Other Functions Select the chest lead. The selected chest lead will be displayed. Change the electrode position, and start the examination. Printing a Fixed Text on the Results Report A fixed text can be printed on the results report. NOTE ...
  • Page 131 Chapter 5 12-Lead Examination (Basic) Other Functions Touch [Menu] - [Setting] - [Read Fixed Text].  The file will be read from the SD card.  [Clear Fixed Text] will initialize the fixed text. Configure results report settings.  To print the fixed text in the comment section of the result report: Set [Setting] - [12-Lead] - [12-Lead Auto Record] - [Results Report] - [Edit Comment Section] to "Fixed Text."...
  • Page 132 Chapter 5 12-Lead Examination (Basic) Other Functions Touch the [Report Type] function key.  The report type selection window will be displayed. Select an examination set to the changed report format.  The report format will temporarily change to the selected examination's report format. The selected examination will appear in the [Examination Mode] display area.
  • Page 133 Chapter 5 12-Lead Examination (Basic) Other Functions Checking DMS Transmission It is possible to confirm the status of transmission after sending examination data to DMS. Set [Setting] - [File] - [General] - [Check DMS] to "Yes." Touch [Check DMS] in the result screen. ...
  • Page 134 Chapter 5 12-Lead Examination (Basic) Other Functions 5-44...
  • Page 135 Chapter 6 12-Lead Examination (Advanced Function) Checking the Waveforms using the Freeze 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 It is possible to temporarily pause the waveform display. This is convenient for printing the ECG or confirming details when arrhythmia is found.
  • Page 136 Chapter 6 12-Lead Examination (Advanced Function) Checking the Waveforms using the Freeze Function Freezing the Waveforms Touch [Freeze] when arrhythmia appears. REFERENCE  The waveform is retrieved starting from the point when the limb electrodes are restored. Check the waveform on the freeze display. ●...
  • Page 137 Chapter 6 12-Lead Examination (Advanced Function) Checking the Waveforms using the Freeze Function change the range of display and auto recording.  [Waveform]: Moves to the touched waveform part.  [ ← ]: Moves the waveform one second to the right (displays the waveform one second older than the displayed waveform).
  • Page 138 Chapter 6 12-Lead Examination (Advanced Function) Checking the Saved Waveforms Touch [Thermal] to display the selection window for the report type. Select the report to print. After checking the waveforms, touch [Cancel Freeze]. Checking the Saved Waveforms When the freeze operation is performed, the ECG waveform of maximum 10 minutes will be saved. The saved waveform can be displayed as rhythm waveform, and can be recorded automatically or manually.
  • Page 139 Chapter 6 12-Lead Examination (Advanced Function) Checking the Saved Waveforms The waveform display can be switched in the order of rhythm display, 6 ch, 6 ch× 2 waveforms display. [Memory Image]: Switches the waveform display. To Perform Auto Recording  Freeze the waveform and display the rhythm waveform.
  • Page 140 Chapter 6 12-Lead Examination (Advanced Function) Checking the Saved Waveforms Changes the analysis range. Touch one of the following buttons to change the analysis range. The maximum analysis range is 24 seconds, and the minimum is 8 seconds. Reset: The range set under "Setting" will be applied. Zoom In: Expands both sides of the analysis range by one second each.
  • Page 141 Chapter 6 12-Lead Examination (Advanced Function) Conducting 12-Lead, Arrhythmia and Rhythm Measurements Simultaneously 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 142 Chapter 6 12-Lead Examination (Advanced Function) Conducting 12-Lead, Arrhythmia and Rhythm Measurements Simultaneously Select the combination to analyze. Touch the combination to analyze.  [12-Lead]: Performs a 12-lead analysis on the analysis range (indicated by the green border).  [Arrhythmia]: Performs an arrhythmia analysis on the recorded area (green area). ...
  • Page 143 Chapter 6 12-Lead Examination (Advanced Function) Simultaneously Analyzing Multiple Waveform Locations Simultaneously Analyzing Multiple Waveform Locations The freeze function can be used to simultaneously analyze maximum of 10 waveform locations. NOTE  Arrhythmia and rhythm measurement examinations cannot be analyzed when multiple analyses are performed.
  • Page 144 Chapter 6 12-Lead Examination (Advanced Function) Recording the ECG Waveforms at Rest and After Exercise (Post- Exercise Examination) Touch [Analysis].  Analysis is executed. REFERENCE  Set whether or not to display the result screen after analysis under [Freeze] - [Freeze Result Display] for each examination.
  • Page 145 Chapter 6 12-Lead Examination (Advanced Function) Recording the ECG Waveforms at Rest and After Exercise (Post- Exercise Examination) REFERENCE  Depending on the periodic recording setting, waveform acquisition or recording may be in progress at the set time. In such case, periodic recording will not be performed. ...
  • Page 146 Chapter 6 12-Lead Examination (Advanced Function) Recording the ECG Waveforms at Rest and After Exercise (Post- Exercise Examination) Touch [Interval].  The post-exercise timer will start, and the elapsed time will be displayed. REFERENCE  By configuring [Setting] - [Post] - [Post (Periodic)] - [Rec. Interval] - [Fixed Time Recording], recording can be performed at specified time.
  • Page 147 Chapter 6 12-Lead Examination (Advanced Function) Recording the ECG Waveforms at Rest and After Exercise (Post- Exercise Examination) Examples of Recording ● Post-Exercise (Auto Recording) The example of the following is shown: Waveform Acquiring Time: 10 seconds Calibration Position: Beginning 6-13...
  • Page 148 Chapter 6 12-Lead Examination (Advanced Function) Recording the ECG Waveforms at Rest and After Exercise (Post- Exercise Examination) ● Post-Exercise (Manual Recording) ● Post-Exercise (Summary Report) ● Post-Exercise (Result Report): with FP-908A The example of the following is shown: Result Report: DOM1 6-14...
  • Page 149 Chapter 6 12-Lead Examination (Advanced Function) Recording the ECG Waveforms at Rest and After Exercise (Post- Exercise Examination) ● Post-Exercise (Result Report): without FP-908A The example of the following is shown: Results Report: DOM ● Periodic Compressed Recording The printing example of the following is shown: Compressed Recording: 10mm/s Lead: Spare Lead 1 (6ch) Calibration Position: After Waveform...
  • Page 150 Chapter 6 12-Lead Examination (Advanced Function) Time Series Waveform Comparison Time Series Waveform Comparison For the standard ECG examination, the previously recorded 12-lead dominant waveform and the current 12-lead real- time waveform can be simultaneously displayed. In addition, current and previous analysis results (interpretation) can be displayed simultaneously. Required Settings Select "Yes"...
  • Page 151 Chapter 6 12-Lead Examination (Advanced Function) Time Series Waveform Comparison  Freeze display The dominant waveform in the last data is displayed along with the current frozen waveform. If there is no data from last time, then the dominant waveform from last time will be displayed as the baseline. Press the ◀...
  • Page 152 Chapter 6 12-Lead Examination (Advanced Function) Time Series Waveform Comparison Entering ID to Search Previous Data in Storage Media The previous data can be searched from the storage media by entering an ID. Enter the ID and other patient information. Search previous data from the storage media.
  • Page 153 Chapter 6 12-Lead Examination (Advanced Function) Time Series Waveform Comparison Previous data will be displayed. REFERENCE  Entering a different ID will clear the past data to compare. Selecting Previous Data from Storage Media Any data on the storage media can be selected as previous data. Touch [Time Compare].
  • Page 154 Chapter 6 12-Lead Examination (Advanced Function) Time Series Waveform Comparison Touch [Search]. Enter the search conditions and touch [Search].  A data list matching the search conditions will be displayed. Select the data to compare. Touch the data to compare. The selected data will be highlighted. Touch [Enter].
  • Page 155 Chapter 6 12-Lead Examination (Advanced Function) Checking Analysis Results from Previous Examination Checking Analysis Results from Previous Examination The waveform and analysis results of the previous examination are displayed in a standard ECG examination. Enter the ID number. Touch [Previous Exam.]. ...
  • Page 156 Chapter 6 12-Lead Examination (Advanced Function) ACS Diagnostic Support Function: with FP-908A REFERENCE  Do not remove storage media while acquiring data from it. Touch [Back].  The device returns to the examination screen. ACS Diagnostic Support Function: with FP-908A NOTE ...
  • Page 157 Chapter 6 12-Lead Examination (Advanced Function) ACS Diagnostic Support Function: with FP-908A  Checking the Results and Printing  ・Functions that can be used after analysis ( P5-11 )  ・ Entering the ACS Question on the Analysis Result Display( P6-25 )...
  • Page 158 Chapter 6 12-Lead Examination (Advanced Function) ACS Diagnostic Support Function: with FP-908A Enter the ACS Question.  [Next]: Proceeds to next question.  [Complete]: Ends the question.  The analysis result will be displayed. ( "Functions on the ACS Analysis Result Display" P6-25) Entering the ACS Question Before the Examination Select “Abnormal Finding”...
  • Page 159 Chapter 6 12-Lead Examination (Advanced Function) ACS Diagnostic Support Function: with FP-908A Enter the ACS Question.  [Next]: Proceeds to next question.  [Complete]: Ends the question.  Continue the ECG examination at rest. ( "12-Lead Examination (Basic)" P5-1) Entering the ACS Question from the Analysis Result Display Touch [ACS Question] in the analysis result screen.
  • Page 160 Chapter 6 12-Lead Examination (Advanced Function) ACS Diagnostic Support Function: with FP-908A NOTE  The synthesized 6 ch waveform may differ slightly from the waveform that was actually measured.  The ACS reference ECG findings can be displayed. The ACS ECG diagnosis comment will be displayed in explanation area. ...
  • Page 161 Chapter 6 12-Lead Examination (Advanced Function) ACS Diagnostic Support Function: with FP-908A ● ACS Guide Report The following setting is required. Set [Setting] - [12-Lead] - [12-Lead Auto Record] - [Result Report 2] - [ACS Guide Report] to [Always/Abnormal Finding]. REFERENCE ...
  • Page 162 Chapter 6 12-Lead Examination (Advanced Function) ACS Diagnostic Support Function: with FP-908A The continuous waveform is displayed. 3 Overall Result Display Area ACS diagnosis comments, symptom analysis comments (if symptom was entered), and comprehensive com- ments are displayed. Depending on the ACS ECG analysis result, the background of the comprehensive result display area changes to either orange or yellow.
  • Page 163 Chapter 6 12-Lead Examination (Advanced Function) ACS Diagnostic Support Function: with FP-908A 2 Analysis Result Summary [ACS Reference ECG]: The representative interpretation suggestive of ACS will be displayed. [Symptom Analysis]: If symptom is entered, the entered content will be displayed. [Synth.
  • Page 164 Chapter 6 12-Lead Examination (Advanced Function) Synthesized 18-Lead Continuous Waveform Function Synthesized 18-Lead Continuous Waveform Function In addition to the standard 12-lead, it is also possible to display and print continuous waveforms for synthesized leads in the result screen when using the 12-lead examination ACS diagnostic aid function. Synthesized 18-Lead Screen Touch [Display] at the bottom of the 12-lead examination result screen.
  • Page 165 Chapter 6 12-Lead Examination (Advanced Function) Synthesized 18-Lead Continuous Waveform Function  REFERENCE  The display of recorded waveforms can be configured in the settings of [12-Lead] - [General] - [Result: Result Disp. Waveform].  If the screen display is 6 ch, the displayed lead can be switched by touching [Lead ← ] or [Lead →...
  • Page 166 Chapter 6 12-Lead Examination (Advanced Function) Synthesized 18-Lead Continuous Waveform Function  6ch×2+3ch  6ch×2+6ch REFERENCE  It is also possible to print by pressing the [START/STOP] key.  The operation during printing can be changed by setting [12-Lead] - [12-Lead Auto Record] - [Results Report: Synthesized 18-Lead Report].
  • Page 167 Chapter 6 12-Lead Examination (Advanced Function) Auto Capture Function Auto Capture Function By using the auto capture function, it is possible to select the waveform to save from the candidate waveforms as a candidate waveform in an area with little noise. The basic operation flow is as follows.
  • Page 168 Chapter 6 12-Lead Examination (Advanced Function) Auto Capture Function amination Screen" P13-76) Waveform Acquisition Waveform acquisition starts when electrodes are attached, or when all lead-offs are resolved. NOTE  If a lead off occurs during waveform acquisition, waveform acquisition will be canceled. REFERENCE ...
  • Page 169 Chapter 6 12-Lead Examination (Advanced Function) Auto Capture Function When [Noise Undetected] is used, the candidate waveform is taken from ranges without noise detected.  If there are less than four waveforms with high severity, a waveform with little noise is taken. ...
  • Page 170 Chapter 6 12-Lead Examination (Advanced Function) Auto Capture Function or "After Wave Report."  If the candidate waveform list is not displayed, then it will not be possible to confirm and save candidate waveforms #2 to #4. Candidate Waveform Analysis Result It is possible to check, save, and print the candidate waveform analysis result.
  • Page 171 Chapter 6 12-Lead Examination (Advanced Function) Dextrocardia Mode Function Dextrocardia Mode Function The dextrocardia mode is a function that can only be used to perform examinations on patients with dextrocardia by switching the attachment of chest electrodes. Switching to Dextrocardia Mode There are three methods available for switching to dextrocardia mode.
  • Page 172 Chapter 6 12-Lead Examination (Advanced Function) Dextrocardia Mode Function Examinations in Dextrocardia Mode It is possible to conduct an ECG examination in dextrocardia mode by simply changing the attachment of the chest electrodes. Switch to dextrocardia mode. Attach chest electrodes C3 to C6 in reverse. Conduct the examination.
  • Page 173 Chapter 6 12-Lead Examination (Advanced Function) Quality Control Task Support Functions Quality Control Task Support Functions These functions are aimed at assisting with daily quality control tasks. Measurement data is saved in a dedicated device quality control/technique quality control mode. NOTE ...
  • Page 174 Chapter 6 12-Lead Examination (Advanced Function) Quality Control Task Support Functions Touch [Menu] - [QC Support] to display the quality control support screen. The following functions can be used in the quality control support screen: Function Description Setting Device No. Sets a unique number that can be assigned to the device.
  • Page 175 Chapter 6 12-Lead Examination (Advanced Function) Quality Control Task Support Functions Setting Device No. A unique device number can be assigned to this device for use in quality control tasks. Touch [Enter] by "Device No." on the quality control support screen. Enter the characters in the entry window and touch Printing List Reports It is possible to print a list of quality control data.
  • Page 176 Chapter 6 12-Lead Examination (Advanced Function) Quality Control Task Support Functions Touch [List].  Prints the list report. ● Report Example: Device quality control list report NOTE  If " * " is printed on the left side of a measurement value, then that value is out of the set range.
  • Page 177 Chapter 6 12-Lead Examination (Advanced Function) Quality Control Task Support Functions Touch [Graph Printing].  Prints the graph report. ● Report Example NOTE  Long-term storage of thermal paper can cause the printing to grow fainter. When storing reports over the long term, it is suggested to digitize them by scanning or some other method.
  • Page 178 Chapter 6 12-Lead Examination (Advanced Function) Quality Control Task Support Functions Saving Quality Control Data in CSV Format It is possible to save quality control data to external media in CSV format. Touch either [Device QC] or [Technique QC] on the quality control support screen to save one or the other. Set a media to this device.
  • Page 179 Chapter 6 12-Lead Examination (Advanced Function) Quality Control Task Support Functions Touch [Set Range] in the quality control support screen. Touch the maximum and minimum values for each measurement value and enter the values. Touch to close the range setting window. REFERENCE ...
  • Page 180 Chapter 6 12-Lead Examination (Advanced Function) Using the Wireless Patient Module Touch the media to save in the "Save to" window.  A CSV file is saved on the external media. REFERENCE  This device stores the device status each time [Status Output] is executed. It is possible to save maximum of 100 items in CSV format.
  • Page 181 Chapter 6 12-Lead Examination (Advanced Function) Using the Wireless Patient Module Touch [Setting]. Touch [External Device]. Touch [Wireless Device]. 6-47...
  • Page 182 Chapter 6 12-Lead Examination (Advanced Function) Using the Wireless Patient Module Set "Yes" for [WPM Function]. While holding down on the WPM, press . This turns the power on.  When the power turns on, lights or flashes in green. NOTE ...
  • Page 183 Chapter 6 12-Lead Examination (Advanced Function) Using the Wireless Patient Module NOTE  If the WPM is not detected, touch [Update].  The Wireless Patient Module will not be detected if it is connected to another device. Disconnect from the other device and start pairing mode. Select the WPM to connect.
  • Page 184 Chapter 6 12-Lead Examination (Advanced Function) Using the Wireless Patient Module  For details on the procedure to switch patients, refer to "Switching Patients" P6-56  Changing Wireless Patient Module Pairing NOTE  Set [WPM Function] to [Yes].  "Pairing the Wireless Patient Module" P6-46 Touch the information button.
  • Page 185 Chapter 6 12-Lead Examination (Advanced Function) Using the Wireless Patient Module NOTE  If does not flash, turn the Wireless Patient Module off, then repeat step 2. Touch [Search]  While searching, "Searching Wireless Patient Module." is displayed. Select the Wireless Patient Module to connect. Confirm that the selected Wireless Patient Module S/N is correct.
  • Page 186 Chapter 6 12-Lead Examination (Advanced Function) Using the Wireless Patient Module  Connecting the Wireless Patient Module Turn ON the power of the Wireless Patient Module after turning ON the power of this device. The devices will be automatically connected. NOTE ...
  • Page 187 Chapter 6 12-Lead Examination (Advanced Function) Using the Wireless Patient Module  Deleting the Wireless Patient Module Follow these steps to disconnect the pairing of the device and the Wireless Patient Module. Press [Setting] - [External Device] - [Wireless Device] - [WPM] - [Delete]. ...
  • Page 188 Chapter 6 12-Lead Examination (Advanced Function) Using the Wireless Patient Module Display the examination screen. Connect the Wireless Patient Module.  "Connecting the Wireless Patient Module" P6-52 Touch the information button. Touch [Comm. Test].  The communication test begins. During the communication test, waveform data is measured for 30 seconds. During measurement, "Measuring missing data interval."...
  • Page 189 Chapter 6 12-Lead Examination (Advanced Function) Using the Wireless Patient Module Check the displayed test results.  If "Measured for 30 seconds, and missing data interval was not detected." is displayed, no waveform data is missing.  If “Measured for 30 seconds, and missing data interval of X.XXX seconds was detected.” is displayed, waveform data is missing.
  • Page 190 Chapter 6 12-Lead Examination (Advanced Function) Using the Wireless Patient Module Conducting an ECG Examination with the Wireless Patient Module  Switching Patients REFERENCE  Set [Setting] - [External Device] - [Wireless Device] - [WPM] - [WPM Function] to "Yes" in advance.
  • Page 191 Chapter 6 12-Lead Examination (Advanced Function) Using the Wireless Patient Module This switches to the patient using the Wireless Patient Module, and switches the destination for ECG acquisition as well. REFERENCE  It is also possible to switch between patients by pressing the Switch Patient key. ...
  • Page 192 Chapter 6 12-Lead Examination (Advanced Function) Using the Wireless Patient Module  Waveform is not displayed.  The waveform report for the waveform being acquired is printed at the bottom of the print area.  Freeze function memory image is displayed in purple. ...
  • Page 193 Chapter 7 Arrhythmia ECG Required Settings Chapter 7 Arrhythmia ECG This chapter describes how to perform a long term 3-lead arrhythmia recording. The basic operation flow of the arrhythmia examination is as follows.  Setup Configure the settings as necessary. ...
  • Page 194 Chapter 7 Arrhythmia ECG Recording While Analyzing Arrhythmia (with FP-908A) It is also possible to set them by touching [Lead] in the examination screen. NOTE  The first examination lead becomes the R wave detection lead. Settings for Waveform Recording Duration Set the time for acquiring waveforms.
  • Page 195 Chapter 7 Arrhythmia ECG Recording While Analyzing Arrhythmia (with FP-908A) Touch [Arrhythmia].  Enter the patient information. (Refer to Chapter 4 "Entering Patient Information".)  Attach the ECG electrodes and check that ECG waveforms appear on the display. ( "Attaching Electrodes" P3-1) REFERENCE ...
  • Page 196 Chapter 7 Arrhythmia ECG Recording While Analyzing Arrhythmia (with FP-908A) The analysis result will be displayed after waveform acquisition. CAUTION  If [Back] is pressed, the device returns to the home display without saving results. Functions That Can Be Used After Analysis The following items can be checked in the analysis result display before printing a report.
  • Page 197 Chapter 7 Arrhythmia ECG Recording While Analyzing Arrhythmia (with FP-908A) ● [Thermal]  Any report can be printed. Select the report to output. Refer to "Recording Examples" P7-5 for printing contents. Canceling an Examination If the (START/STOP) key on the operation panel is pressed during an examination, or if an electrode is disconnected, then the examination will be canceled.
  • Page 198 Chapter 7 Arrhythmia ECG Recording While Analyzing Arrhythmia (with FP-908A) ● Detailed Arrhythmia Measurement Report ● Arrhythmia Analysis Report The example of the following is shown: Examination Leads: II, aVF, V5 Waveform Acquiring Time: 40 seconds...
  • Page 199 Chapter 7 Arrhythmia ECG Recording While Measuring Arrhythmia (without FP-908A) Recording While Measuring Arrhythmia (without FP-908A) 3-lead ECG is acquired for 40 seconds to 3 minutes, and printed in a prescribed format. To Start Recording Touch [Exam.]. Touch [Arrhythmia].  Enter the patient information.
  • Page 200 Chapter 7 Arrhythmia ECG Recording While Measuring Arrhythmia (without FP-908A)  Touch one of [40 sec]/[1 min]/[2 min]/[3 min]/[100 bts]/[200 bts]. Change the examination leads, if necessary. Press the (START/STOP) key on the operation panel.  Press the (START/STOP) key to start acquiring the selected 3-lead waveforms. ...
  • Page 201 Chapter 7 Arrhythmia ECG Recording While Measuring Arrhythmia (without FP-908A) ● [Detailed Value] Detailed values will be displayed. ● [Save] The media selection window will be displayed. Select the media to save the data. ● [Thermal]  Any report can be printed. Select the report to output. Refer to "Recording Examples"...
  • Page 202 Chapter 7 Arrhythmia ECG Recording While Measuring Arrhythmia (without FP-908A) Recording Examples ● Arrhythmia Waveform Report ● Detailed Arrhythmia Measurement Report 7-10...
  • Page 203 Chapter 8 Rhythm Measurement Recording While Measuring a Rhythm Waveform Chapter 8 Rhythm Measurement This chapter explains how to perform a rhythm measurement. The basic operation flow of the rhythm measurement is as follows.  Setup Configure the settings as necessary. ...
  • Page 204 Chapter 8 Rhythm Measurement Recording While Measuring a Rhythm Waveform To Start Recording Touch [Exam.]. Touch [Rhythm Meas.].  When power is turned ON, the examination screen set in [Register Examination > On Start-up] is displayed.  Attach the electrodes to record to the patient. ( "Attaching Electrodes"...
  • Page 205 Chapter 8 Rhythm Measurement Recording While Measuring a Rhythm Waveform  Touch the time for acquiring the waveform. NOTE  Even if the examination time is specified as 100 or 200 beats, waveform acquisition will be cut off at a maximum of 10 minutes. Select the leads for performing the examination.
  • Page 206 Chapter 8 Rhythm Measurement Recording While Measuring a Rhythm Waveform ● [Display] The result display can be selected. ● [Result] [Waveform] ● [Detailed Value] The measured rhythm waveform will be displayed. Detailed values will be displayed. The R-R interval for all measured heart beats will be displayed. ●...
  • Page 207 Chapter 8 Rhythm Measurement Recording While Measuring a Rhythm Waveform Recording Examples ● R-R Measured Waveform Report (Waveform) Examination Conditions Examination Time: 1 min Examination Lead: II ● Rhythm Measurement Report Examination Conditions Examination Time: 1 min Examination Lead: II REFERENCE ...
  • Page 208 Chapter 8 Rhythm Measurement Recording While Measuring a Rhythm Waveform...
  • Page 209 Chapter 9 15-Lead Examination Function Keys Used in Examinations Chapter 9 15-Lead Examination This section explains the basic operation procedure of the 15-lead examination.  Refer to "15-Lead Post-Exercise Examination" P9-20 for 15-lead post-exercise examination. NOTE  15-Lead examination can be performed by connecting the ECG amplifier module (EE-51). The basic operation flow of the 15-lead examination is as follows.
  • Page 210 Chapter 9 15-Lead Examination Type of Waveform Recording *3: During offline mode, operation is performed assuming that network connection is not made. Online auto saving to DMS is not performed. *4: Displayed only when there is a previous examination.  Auto Mode (while printing) HOLD ...
  • Page 211 Chapter 9 15-Lead Examination Analyzing and Recording Waveforms Automatically: with FP-908A  "Recording Examples" P5-8 for printing details of the DOM1 report, printing procedure of detailed measurement report, etc. ・DOM1 ・DOM2 + Rhythm 1ch ・DOM2 + Rhythm 2ch ・Cover Report ・Waveform + Cover Report Analysis Report Detailed Measurement Report...
  • Page 212 Chapter 9 15-Lead Examination Analyzing and Recording Waveforms Automatically: with FP-908A Each time [Change Display] is touched, the display switches in the order of "6 ch x 2 + Rhythm " → "6 ch x 2 + 3 ch " →...
  • Page 213 Chapter 9 15-Lead Examination Analyzing and Recording Waveforms Automatically: with FP-908A Select "Auto" for recording.  The default setting is "Auto".  Touch [Auto/Manual] to switch between auto recording and manual recording.  When "Auto" is set: The leads will be normally displayed. ...
  • Page 214 Chapter 9 15-Lead Examination Analyzing and Recording Waveforms Automatically: with FP-908A REFERENCE   Refer to "Functions That Can Be Used After Analysis" P9-7 for operation of the analysis result display. Recording Examples ● Auto Recording (Directly Written Recording) The example of the following is shown: Waveform Report: 3chx4 + Rhythm Waveform Acquiring Time: 10 seconds Calibration Position: Beginning...
  • Page 215 Chapter 9 15-Lead Examination Analyzing and Recording Waveforms Automatically: with FP-908A ● Detailed Measurement Report The following setting is required. Set "Yes" for “Det. Meas. Report” under [Setting] - [15-Lead] - [15L Auto Rec.] - [Result Report]. Functions That Can Be Used After Analysis The following items can be checked in the analysis result display before printing an analysis report.
  • Page 216 Chapter 9 15-Lead Examination Automatically Recording Measurements: without FP-908A ● [Detailed Value] ● [Analysis Guide] Detailed measurements will be displayed. Analysis guide for the interpretations will be displayed. ● [Save] ● [Thermal] The media selection window will be displayed. Select the The report can be printed on the built-in thermal recorder.
  • Page 217 Chapter 9 15-Lead Examination Automatically Recording Measurements: without FP-908A To Start Recording Touch [Exam.]. Touch [15-Lead].  When the power is turned ON, the registered examination for startup will be displayed.  Enter the patient information. ( "Entering Patient Information" P4-1) ...
  • Page 218 Chapter 9 15-Lead Examination Automatically Recording Measurements: without FP-908A  Check the current waveforms shown in the display.  When the waveforms of 6 channels are displayed, the displayed leads will change. Press the ◀ , ▶ keys on the operation panel to switch the lead. ...
  • Page 219 Chapter 9 15-Lead Examination Automatically Recording Measurements: without FP-908A Recording Examples ● Auto Recording (Directly Written Recording) The example of the following is shown: Waveform Report: 3chx4 + Rhythm 1ch Waveform Acquiring Time: 10 seconds Calibration Position: Beginning Rhythm Lead: Lead II ●...
  • Page 220 Chapter 9 15-Lead Examination Automatically Recording Measurements: without FP-908A ● Detailed Measurement Report The following setting is required. Set "Yes" for “Det. Meas. Report” under [Setting] - [15-Lead] - [15L Auto Rec.] - [Result Report]. Functions That Can Be Used After Measurement The following items can be checked in the measurement result display before printing an measurement report.
  • Page 221 Chapter 9 15-Lead Examination Manual Recording ● [Detailed Value] ● [Save] Detailed measurements will be displayed. The media selection window will be displayed. Select the media to save the data. ● [Thermal] The report can be printed on the built-in thermal recorder. ...
  • Page 222 Chapter 9 15-Lead Examination Manual Recording Touch [15-Lead].  When the power is turned ON, the registered examination for startup will be displayed.  Enter the patient information. ( Chapter 4 "Entering Patient Information")  Attach the ECG electrodes and check that ECG waveforms appear on the display. ( "Attaching Electrodes"...
  • Page 223 Chapter 9 15-Lead Examination Manual Recording …"STD" "Block 1", and so forth. The lead type of the waveform to be recorded is highlighted. Lead Mode 15-lead Cabrera Lead Channels 15ch 15ch Block 1 I to III I to aVF I to EXTRA aVL to aVR aVL to III aVL to EXTRA...
  • Page 224 Chapter 9 15-Lead Examination Manual Recording Recording Examples ● Manual Recording (3ch) The example of the following is shown: Lead: Limb (I, II, III) ● Manual Recording (6ch) The example of the following is shown: Lead: Limb (I, II, III, aVR, aVL, aVF) 9-16...
  • Page 225 Chapter 9 15-Lead Examination Manual Recording ● Manual Recording (6ch) The example of the following is shown: Lead: Limb, Chest ● Manual Recording (12ch) The example of the following is shown: Lead: Limb, Chest Calibration Position: After Waveform 9-17...
  • Page 226 Chapter 9 15-Lead Examination Recording Waveforms from Several Seconds Before (Review) ● Manual Recording (15ch) The example of the following is shown: Lead: Limb, Chest, EXTRA Calibration Position: After Waveform Recording Waveforms from Several Seconds Before (Review) 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.
  • Page 227 Chapter 9 15-Lead Examination Checking the Waveforms using the Freeze Function Checking the Waveforms using the Freeze Function It is possible to temporarily pause the waveform display. This is convenient for printing the ECG or confirming details when arrhythmia is found. Waveforms of up to 10 minutes can be displayed during the freeze mode. By touching the image at the bottom right corner of the freeze display, the display can be switched in the order of 15 ch waveform →...
  • Page 228 Chapter 9 15-Lead Examination Extending Recording REFERENCE   The same procedure with the 12-lead examination can be used. ( "Conducting 12-Lead, Arrhythmia and Rhythm Measurements Simultaneously" P6-7) Extending Recording It is possible to extend recording. Recording is automatically extended if the grade of the interpretation exceeds a set value, and it is also possible to extend with a key operation.
  • Page 229 Chapter 9 15-Lead Examination Time Series Waveform Comparison Time Series Waveform Comparison For the standard ECG examination, the previously recorded 15-lead dominant waveform and the current 15-lead real- time waveform can be simultaneously displayed. In addition, current and previous analysis results (interpretation) can be displayed simultaneously. REFERENCE ...
  • Page 230 Chapter 9 15-Lead Examination Other Functions Touch either one of the leads from 1 to 4. On the displayed window, assign the lead for V1 to V6. Touch [ ← ], [ → ] to select the lead to be changed. The selected lead will be displayed in blue.
  • Page 231 Chapter 9 15-Lead Examination Other Functions Touch [Enter]. Changing the Chest Leads The leads for V1 to V9, V1R to V9R can be specified. REFERENCE  To change the chest lead combination, perform the following settings. REFERENCE  15-Lead Examination: [Setting] - [15-Lead] - [General] - [Lead] - [EXTRA Lead 1 (to 4)] ...
  • Page 232 Chapter 9 15-Lead Examination Other Functions The selected chest lead will be displayed. Change the electrode position, and start the examination. 9-24...
  • Page 233 Chapter 10 Enhanced ECG Before the Examination Chapter 10 Enhanced ECG This chapter explains how to perform an enhanced ECG. NOTE  To use the enhanced ECG function, it is necessary to install the optional ECG Analysis software (FP-908A). The basic process for performing an enhanced ECG examination is as follows: ...
  • Page 234 Chapter 10 Enhanced ECG Function Keys Used in Examinations ACS analysis is always performed. The following functions are disabled. Switching Chest Leads (including dextrocardia mode) Interval Recording Guide Function Auto Filter Function Time Comparison Function Auto Capture Function  Examination Flow The examination flow is as follows.
  • Page 235 Chapter 10 Enhanced ECG Performing an Examination Touch [Enhanced ECG]. When the power is turned ON, the registered examination for startup will be displayed. REFERENCE  The screen shown when an enhanced ECG examination is started depends on the settings. Set this in Enhanced ECG >...
  • Page 236 Chapter 10 Enhanced ECG Performing an Examination function keys, touch [Re-enter]. This starts analysis of background waveforms. If the conditions are met for starting analysis, background waveform analysis will start automatically. REFERENCE  If not all of the conditions are met for starting analysis, background waveform analysis will not start automatically.
  • Page 237 Chapter 10 Enhanced ECG Performing an Examination There is chest pain in a TIMI item in the patient information. Touch the 18-Lead function key to display the 18-lead screen. If the conditions are met for starting analysis, background waveform analysis will start automatically. The examination is performed for the set length of time.
  • Page 238 Chapter 10 Enhanced ECG Performing an Examination ST Change Chart. The ST value of the current waveform is displayed. ST Graph ST Radar Chart 1 Limb leads (I, -aVR, II, aVF, III, aVL) 2 Chest leads (V1, V2, V3, V4, V5, V6) 3 Right side chest leads (V3R, V4R, V5R) + back side chest leads (V7, V8, V9) 4 Limb leads (I, -aVR, II, aVF, III, aVL) 5 Chest leads (V1, V2, V3, V4, V5, V6) + right side chest leads (V3R, V4R, V5R) + back side chest leads (V7, V8, V9)
  • Page 239 Chapter 10 Enhanced ECG Report Examples 6 [12-Lead] Finishes the examination and goes to 12-lead screen. REFERENCE  If the summary report has not been saved, a confirmation message will ask whether or not to save it. Ending an Examination If the examination time ends, or an electrode is removed (lead off), then the examination will end.
  • Page 240 Chapter 10 Enhanced ECG Report Examples ● 18-Lead Summary Report Output if [Setting > Enhanced ECG > General > Summary Report > Output Lead] is set to [18-Lead]. The example of the following is shown: Waveform area: base waveform, MAX-ST waveform, last recorded waveform ●...
  • Page 241  Use only SD cards and USB memory devices specified by Fukuda Denshi.  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.
  • Page 242 Chapter 11 Transferring Files Initializing  Avoid using or storing media in areas with extreme changes in temperature.  Do not allow media to get wet.  Do not dissemble media.  Avoid using or storing media near magnets or devices with a magnetic field. ...
  • Page 243 Chapter 11 Transferring Files Saving Examination Data  Use only SD cards and USB memory devices specified by Fukuda Denshi. Set the media to this device. Touch [Menu] - [File/Communication] - [Media Management] - [Format]. Select the media and format type.
  • Page 244 Chapter 11 Transferring Files Saving Examination Data 3 Save manually during examination (file utility operation) The examination data can be saved using the file utility function.  "Saving Manually (File Utility Operation)" 11-p. 5) Saving Automatically Examination data is automatically saved on the specified media after each examination is finished. Configure the following items under "Setting"...
  • Page 245 Chapter 11 Transferring Files Saving Examination Data  The data will be saved on the selected media. Saving Manually (File Utility Operation) Save any data in this device's memory to storage media. The storage media can also be selected. Conduct the examination. Set the media to this device.
  • Page 246 Chapter 11 Transferring Files Loading Examination Data Touch the data to save, then touch the [Copy] function key.  It is also possible to display a waveform preview by holding a finger on the 12-lead examination data. Lift your finger to end this display. The previewed data is the data that was touched first.
  • Page 247 Chapter 11 Transferring Files Loading Examination Data Touch [Menu] - [File/Communication] - [File List], then touch [Media] function key. Specify the storage media on which the data to load is saved. Touch the location to retrieve the data from, and then touch [ Touch to select the loaded data, then touch the [Display] function key.
  • Page 248 Chapter 11 Transferring Files Loading Examination Data  MFER format data is only displayed in the file list. Examination data is not displayed. Searching Data It is possible to search by ID, patient name, examination date, and folder number.  Follow the procedure from step 1 to step 3 in "Loading"...
  • Page 249 Chapter 11 Transferring Files Loading Examination Data Touch [Search].  Search process will start. Printing Reports  Follow the procedure from step 1 to step 3 in "Loading" P11-6. Touch the data to be printed. Touch [Report].  A report for the selected examination data is printed. REFERENCE ...
  • Page 250 Chapter 11 Transferring Files Deleting Examination Data Touch [Summary Report].  A summary report is printed for the selected examination data. Printing the Data List Open the function key [2/3] in the data list screen and touch [List].  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.
  • Page 251 Chapter 11 Transferring Files 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" P11-11. Restoring Deleted Data Data deleted from the list is moved to the [Trash Box]. Data in the Trash Box can be restored. Touch the [Trash Box] function key (3/3).
  • Page 252 Chapter 11 Transferring Files Editing Examination Data Touch [Recover]. In the confirmation window, touch [Yes].  The data is restored. REFERENCE  It is not possible to completely erase data in the Trash Box from the storage media. Editing Examination Data Examination data can be edited before saving or retrieving the data.
  • Page 253 Chapter 11 Transferring Files Copying Examination Data Touch the information display area to edit. When the "Patient Information" display area is touched:  Touch the patient information item to be corrected, correct the infor-  mation( "Entering Detailed Information" P4-3), and then touch When the "Interp.
  • Page 254 Chapter 11 Transferring Files Copying Examination Data Touch the data to copy, then touch [1/3]. Touch [Copy]. Confirm the media to copy to and touch [  To change the media to copy the data, press [Change]. When data is copied from media to DMS, the registered on DMS icon is displayed.
  • Page 255 Chapter 11 Transferring Files Naming Folders Naming Folders Folders on SD cards and USB memory devices can be named to organize the saved data clearly. It is possible to print a list of folders. Set the SD card or USB memory in this device. Touch [Menu] - [File/Communication] - [Media Management] - [Folder Management].
  • Page 256 Chapter 11 Transferring Files Using WPA2 Enterprise  The folder management screen will be displayed. Select the media to save the data. Select the folder to save the data. Touch [Folder]. Using WPA2 Enterprise It is possible to communicate using WPA2 Enterprise with this device. Authentication Method Authentication Description...
  • Page 257 Chapter 11 Transferring Files Using WPA2 Enterprise Setup Touch [Setting] on the menu. Touch [Communication]. Configure settings in DMS Settings>Device Info>Wireless LAN>Authentication. REFERENCE  When using WPA2 Enterprise, set either WPA2-EAP-TLS, WPA2-EAP-TTLS, or WPA2- EAP-PEAP. 11-17...
  • Page 258 Chapter 11 Transferring Files Using WPA2 Enterprise Configure the SSID setting. REFERENCE  Set the access point and router SSID. Set the client certificate, private key, and route CA certificate. Select the client certificate, private key, and route CA certificate files from the SD card and USB memory, and then touch [ NOTE ...
  • Page 259 Chapter 11 Transferring Files Using WPA2 Enterprise  Consult with the network administrator regarding the client certificate, private key, and root CA certificate files. Set the pass phrase, login name, and password. Set the pass phrase, login name, and password with 32 single-byte alphanumeric characters and symbols. REFERENCE ...
  • Page 260 Chapter 11 Transferring Files Communication History 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. Printing the Communication History This section explains the method of printing the communication history. Touch [Menu] - [File/Communication] - [Media Management] - [Communication History] in that order.
  • Page 261 Chapter 11 Transferring Files 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 262 Chapter 11 Transferring Files Communication History Erasing the Communication History Touch [Erase History] to erase communication history. Recording Examples ● File List ● Communication History 11-22...
  • Page 263 REFERENCE  For details regarding the IP address, port number, and other settings that must be configured for communicating over a LAN connection, contact your local Fukuda Denshi service representative. Touch [Menu] - [Setting] - [Communication]. 11-23...
  • Page 264 Chapter 11 Transferring Files DICOM Communication Configure the DICOM settings. Touch [DICOM]. Set "Yes" for "Acquire Work List". Set "Yes" for "MPPS". Touch [Menu] - [Setting] - [Patient Info.]. Perform settings for "Patient Reference". Touch [Patient]. Touch [General]. Select "DICOM Work List" for “Patient Reference”. Selecting Work List and Conducting Examination This device connects to the DICOM MWM server via the local area network (LAN), enabling data interactions with the DICOM MWM server.
  • Page 265 Chapter 11 Transferring Files DICOM Communication Touch [DICOM]. The work list will be displayed.  No.: Sorts the list in ascending/descending order of number.  [Patient Info.]: Sorts the list in ascending/descending order of ID, name.  Exam. Date: Sorts the list in ascending/descending order of examination date. ...
  • Page 266 Chapter 11 Transferring Files DICOM Communication REFERENCE  When [Details] is touched while the work list is selected, work list details window will be displayed. The work list details window displays the following information: ID/Name/Age/Gender/Height/Weight/Examination ID/Receipt No./Exam. Date/Inquiring Doctor Searching the Work List Information It is possible to search the work list information with the following search conditions.
  • Page 267 Chapter 11 Transferring Files DICOM Communication Touch [DICOM] to display the work list screen. Touch [Search].  The search window will appear. NOTE [×]: Cancels the search and closes the search window. Search: Searches the work list with the specified conditions. Enter the search condition.
  • Page 268 Chapter 11 Transferring Files DICOM Storage/DIR Function Fixing the Work List by Connecting the ID Reader By connecting the ID reader, the work list of the searched condition can be fixed. Load the patient information from the ID reader before the examination. The work list is automatically fixed and the display returns to the examination screen.
  • Page 269 Chapter 11 Transferring Files DICOM Storage/DIR Function 3 Save manually during examination (file utility operation)  The examination report can be saved using the file utility function. ( "Saving Manually (File Utility Operation)" P11-30) Saving Automatically If DICOM is set to specified media, the report image is automatically saved after each examination. Configure the following items under "Setting"...
  • Page 270 Chapter 11 Transferring Files DICOM Storage/DIR Function Saving Manually (File Utility Operation) The report image for any data stored in this device's internal memory is saved to DICOM Storage. Conduct the examination.  Configure the settings for connecting DICOM Storage to this device. ( "Configuring Settings Necessary for Communication"...
  • Page 271 Chapter 11 Transferring Files DICOM Storage/DIR Function  The report is saved on the DICOM Storage server. Method of Saving to DICOM DIR The following method can be used to save DICOM DIR data. 1 Save automatically after examination The examination report is automatically saved immediately after each examination according to the Setting. ...
  • Page 272 Chapter 11 Transferring Files DICOM Storage/DIR Function ● 12-Lead/Post-Exercise ● Arrhythmia Examination (Results Report) 11-32...
  • Page 273 Chapter 11 Transferring Files DICOM Storage/DIR Function ● Rhythm Examination (All Waveforms + Trend + Histogram Report) 11-33...
  • Page 274 Chapter 11 Transferring Files DICOM Storage/DIR Function 11-34...
  • Page 275 Chapter 12 Recording the Daily Report Overview Chapter 12 Recording the Daily Report This chapter describes how to save/print the daily examination report. Overview The daily report is a function that can be used to save and output recorded information to enable the confirmation of the status of examinations performed up to that point.
  • Page 276 Chapter 12 Recording the Daily Report Recording a Daily Report Touch the desired method for recording. Today: Save/print today's daily report. Specify Date: Specify a date to save/print a daily report.  Touch [Enter] to specify a date, and then touch [ All: Save/print all daily reports recorded in this device.
  • Page 277 Function Keys Sets the arrangement of function keys displayed at the bottom of the P13-76 examination screen. Operation Procedure of Setting Window REFERENCE  Contact Fukuda Denshi for more information on connecting and configuring the settings of ID readers. 13-1...
  • Page 278 Chapter 13 Settings Operation Procedure of Setting Window Touch [Menu] - [Setting]. Touch the desired item to set. Change the settings.  Refer to the explanations below for information on the settings and setting values for each item.   For text entry method, refer to "...
  • Page 279 Chapter 13 Settings ECG Control ECG Control Configure the device settings. REFERENCE  The text in [] indicates the factory default setting.  Items indicated with * can be set in the detailed setting window displayed when [Details] is pressed. General/Power ECG Control >...
  • Page 280 Chapter 13 Settings ECG Control ECG Control > Login Function Setup Item Description Setting Range Login Function Sets whether or not to display the login screen when powering on Yes, [No] or returning from sleep. "Yes" can only be selected if one or more users are registered.
  • Page 281 Chapter 13 Settings ECG Control ECG Control > Lead/Print > Record Setup Item Description Setting Range Print Method Specify the printing method. [Thermal], External Printer Waveform Speed Specify the waveform speed during manual recording. Multiple [5 mm/s], [10 mm/s], [12.5 mm/s], items can be selected.
  • Page 282 Chapter 13 Settings ECG Control Custom Key ECG Control > Custom Key Setup Item Description Setting Range Custom 1 Specify the function to [No (Custom 3, Custom 4)], [Start (Custom 1)], [Stop (Custom 2)], assign to the custom key. ID+1, ID-1, Auto Recording, Manual Recording, Age, Gender, Copy, Custom 2 Delete All Patient, Hold, Save, Result, Hum Filter, Muscle Filter, Drift Filter, 12L (15L)/Cabrera, File, Reset, 1 mV, Lead ←...
  • Page 283 Chapter 13 Settings ECG Control ECG Control > Buzzer Control 1 to 3 Setup Item Description Setting Range Error Tone Volume Set the volume of the tone that sounds when an abnormality 1, 2, [3], 4, 5 occurs in the device. Save File Volume Set the volume of the tone that sounds when file saving is 0, 1, 2, [3], 4, 5...
  • Page 284 Chapter 13 Settings Patient Information Patient Information Configure settings relating to patient information. Patient Patient Information > Patient > General Setup Item Description Setting Range Specify information for inputting ID information. Basic, [Extension (2 rows)], If "Extension (2 rows)" or "Extension (3 rows)" is selected, it will Extension (3 rows) be possible to add additional information along with the basic information such as height, weight, and so on.
  • Page 285 Chapter 13 Settings Patient Information Patient Information > Patient > ID Setup Item Description Setting Range Enter Specifies whether to enter, display and print ID numbers. [Yes], No Number of digits Specifies the number of digits to be used in ID numbers. [12], 3 to 20 ID Auto Increment Specify whether or not to automatically generate ID numbers by...
  • Page 286 Chapter 13 Settings Patient Information Patient Information > Patient > Name Setup Item Description Setting Range Input Area Specifies whether to enter, display and print names. 0 (None), [1], 2 0(None): Does not display name. 1: Displays name. 2: Displays First name, Last name. Name Backup* Yes: Performs backup.
  • Page 287 Chapter 13 Settings Patient Information Medicine-Technician Name Patient Information > Medicine-Tech Name > Medicine-Comment Setup Item Description Setting Range Enter Medicine Info 1,2 Specify whether or not to enter medicine. Yes, [No] Medicine Specify the number of digits of medicine codes. 2 to 4, [2] No.
  • Page 288 Chapter 13 Settings Patient Information Patient Information > Medicine-Tech Name > BP-RR Setup Item Description Setting Range Enter BP Specify whether or not to enter, display and print the patient's [Yes], No blood pressure. Input body position Specify whether or not to enter, display and print the patient's Yes, [No] body position.
  • Page 289 Chapter 13 Settings Patient Information Touch in the following order: [Menu] - [Setting] - [Patient Information] - [Load DMS Settings]. Specify the group to load from the patient information registered in DMS. Touch [DMS].  Load from the group registered in DMS by specifying Department 1 to 4, Med, Symptom, Comment, Doctor, and Technician.
  • Page 290 Chapter 13 Settings Patient Information Change [Read Settings at Start-up] to either [All Settings] or [Partial Settings]. When setting [Read Settings at Start-up] to [Partial Settings], also set [Load Examination Settings] and [Load Patient Information].  To read all settings, set [All Settings]. It is possible to set all settings the same way for multiple ECGs. ...
  • Page 291 Chapter 13 Settings File Patient Information > Load DMS Settings > Comment-Technician Setup Item Description Setting Range Comment Group Specify which comment to load when reading settings from DMS. [None], 1 to 10 Doctor 1, 2 Group Specify which group to load settings for when reading settings [None], 1 to 5 from DMS.
  • Page 292 Chapter 13 Settings File General File > General (With FP-908A) Setup Item Description Setting Range Media (Save) Specifies the media to save the data. [SD Card], USB1-3, DMS, Serial Multiple items can be specified. Port, Shared Folder, DICOM Media (Read) Specify the media to load the data.
  • Page 293 Chapter 13 Settings File File > General (Without FP-908A) Setup Item Description Setting Range Media (Save) Specifies the media to save the data. [SD Card], USB1-3, DMS, Serial Multiple items can be specified. Port, Shared Folder, DICOM Media (Read) Specify the media to load the data. [SD Card], USB1-3, DMS, Internal Memory Auto Save...
  • Page 294 Chapter 13 Settings File Save Conditions File > Save Conditions Setup Item Description Setting Range [No Conditions], ≥ Grade 2, Save Conditions Specify the data save conditions. ≥ Grade 4, Grade 6 only Waveform before Filtering Specify whether or not to save waveform before filtering (12-lead Yes, [No] examination, post-exercise examination, 15-lead examination, 15-lead post-exercise examination).
  • Page 295 Chapter 13 Settings Communication File > Data Output > Communication Condition Setup Item Description Setting Range Communication speed Specifies the communication speed. 1200bps, 2400bps, [4800bps], 9600bps Data bit length Specifies the data bit length. [7], 8 Stop Bit Length Specifies the stop bit length. [1], 2 Parity Specifies the parity bit.
  • Page 296 Chapter 13 Settings Communication Communication > DMS Settings > DMS Settings Setup Item Description Setting Range Host for Save/Read Specify the host for save/read to connect to. [1], 2, 3, 4, 5, 6 Host for Read Only Specify the host for read only to connect to. 1, [2], 3, 4, 5, 6 Shared Folder Host Specify the shared folder host to connect to.
  • Page 297 Chapter 13 Settings Communication Shared Folder Communication > Shared Folder Setup Item Description Setting Range ― Mounted Directory Specify the name of the shared folder set on the Windows computer. Up to 128 single-byte characters can be entered. ― Login Name Specify the login name to access the shared folder.
  • Page 298 Chapter 13 Settings Communication Communication > DICOM > Storage Server Setup Item Description Setting Range Storage Server Specify the AE title in the storage server. Up to 16 single-byte alphanumeric AE Title characters and symbols Storage Server Specify the IP address of the storage server. [0.0.0.0] IP Address Storage Server...
  • Page 299 Chapter 13 Settings External Device External Device Configure settings for connections with external devices. Serial Port External Device > Serial Port Setup Item Description Setting Range Serial port 1 Specify the function for serial port 1. [No], Data Output, Enter Patient Info.
  • Page 300 Chapter 13 Settings External Device External Device > ID Reader 1, 2 > ID Data Format 1 Specifies the start position and end position for loading each item. Setup Item Description Setting Range Check window ID card confirmation window will be displayed. Start/End Position ID/Name/Birth Date (Year/Month/Day)/Gender/Age/Weight/ Height/Department (1 to 4)/Comment (1 to 3)/BP (SYS/DIA)/...
  • Page 301 Chapter 13 Settings 12-Lead Examinations 12-Lead Examinations Set the items for 12-lead examinations. General 12-Lead > 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. Report Only, Display Only, Both, [No] Bold Print...
  • Page 302 Chapter 13 Settings 12-Lead Examinations 12-Lead > General > Lead (With FP-908A) Setup Item Description Setting Range Lead Setting Specify the leads for conducting examinations. [Standard 12-Lead], Cabrera Lead R Wave Lead Specify the lead for detecting R waves. I, [II], III, V1, V2, V3, V4, V5, V6 Switch Chest Lead Displays a warning message if chest leads are switched from Yes, [No]...
  • Page 303 Chapter 13 Settings 12-Lead Examinations 12-Lead > General > Lead (Without FP-908A) Setup Item Description Setting Range Lead Setting Specify the leads for conducting examinations. [Standard 12-Lead], Cabrera Lead R Wave Lead Specify the lead for detecting R waves. I, [II], III, V1, V2, V3, V4, V5, V6 Switch Chest Lead Displays a warning message if chest leads are switched from Yes, [No]...
  • Page 304 Chapter 13 Settings 12-Lead Examinations 12-Lead > General > Result (With FP-908A) ST Display* Specify whether to display ST values for extracted waveforms in [Yes], No the result display. Plot measurement* Specify whether or not to append ST markers to the report. Yes, [No] 12-Lead >...
  • Page 305 Chapter 13 Settings 12-Lead Examinations 12-Lead > General > File (With FP-908A) Setup Item Description Setting Range Auto Save Specify whether or not to automatically save the ECG after Yes, [No] automatic recording. Save at Periodic Rec. Specify whether to automatically save the ECG data during Yes, [No] interval recording.
  • Page 306 Chapter 13 Settings 12-Lead Examinations 12-Lead > General > Recording Interval (Without FP-908A) Setup Item Description Setting Range Interval Recording Specify interval for automatic recording. No, 30 sec, 1 min, 2 min, [3 min], 4 min, 5 min, 10 min, 15 min, 30 min, 60 min Fixed Time Recording Specify the time for automatic recording.
  • Page 307 Chapter 13 Settings 12-Lead Examinations REFERENCE  This function is available only if analysis function is enabled by installing the FP-908A. 12-Lead > General > Auto Capture (With FP-908A) Setup Item Description Setting Range Auto Capture Function Specify whether or not to perform examinations using the auto Interpretation, Noise Undetected, capture function.
  • Page 308 Chapter 13 Settings 12-Lead Examinations 12-Lead > Freeze (With FP-908A) Analyze Calibration Wave Specify whether or not to perform analysis if the analysis range Yes, [No] includes a calibration wave. 12-Lead > Freeze (Without FP-908A) Setup Item Description Setting Range Freeze Waveform Specify the waveform display for when using the freeze function.
  • Page 309 Chapter 13 Settings 12-Lead Examinations 12-Lead Manual Recording 12-Lead > 12L Manual Rec. > 12L Manual Rec. (With FP-908A) Setup Item Description Setting Range Recording Channels Specify the number of channels for 12-lead manual recording. 3ch, [6ch], 12ch Adjust Recording Position Adjust the print position of the waveform. No, Centered, [Proportional] No: Adjustment is not performed.
  • Page 310 Chapter 13 Settings 12-Lead Examinations 12-Lead > 12L Manual Rec. > Results Report (With FP-908A) Setup Item Description Setting Range Results Report Specify whether or not to output the results report. [Yes], No Report Format Specify the results report format. Cover, [DOM1], DOM2+Rhythm Cover: Prints patient information and interpretation.
  • Page 311 Chapter 13 Settings 12-Lead Examinations 12-Lead > 12L Manual Rec. > Results Report (With FP-908A) Plot measurement* Specify whether or not to print the points used in waveform Yes, [No] measurement. Auto Sensitivity* Specify the auto sensitivity for the dominant waveform of the No, [Chest Leads], All Leads results report.
  • Page 312 Chapter 13 Settings 12-Lead Examinations 12-Lead Auto Recording 12-Lead > 12-Lead Auto Record > 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 sensitivity of 1 cm/mV, its lead block will be recorded again with auto sensitivity.
  • Page 313 Chapter 13 Settings 12-Lead Examinations 12-Lead > 12-Lead Auto Record > Waveform Report (WIthout FP-908A) Waveform Report Order Specify the ECG waveform recording order during 12-lead [Standard], Reverse recording. Waveform Type Continuous: Prints the waveform of each lead block as a [Continuous], continuous report, total time to be the specified time.
  • Page 314 Chapter 13 Settings 12-Lead Examinations 12-Lead > 12-Lead Auto Record > Results Report (Without FP-908A) Setup Item Description Setting Range  Results Report "12-Lead > 12L Manual Rec. > Results Report (Without FP-908A)" P13-35) Report Format Edit Comment Section Edit Numeric Data Section Edit MEMO Detailed Measurement...
  • Page 315 Chapter 13 Settings 12-Lead Examinations 12-Lead > 12-Lead Auto Record > Print/PDF (With FP-908A) Setup Item Description Setting Range Waveform Report Specify whether or not to output the waveform report. Yes, [No] Report Format Specify the format for 12-lead recording. 3ch x 4, 3ch x 4+Rhythm 1ch, 3ch x 4+Rhythm 2ch, [6ch x 2], 6ch x 2+Rhythm 1ch, 12 ch...
  • Page 316 Chapter 13 Settings 12-Lead Examinations 12-Lead > 12-Lead Auto Record > DICOM (Without FP-908A) Setup Item Description Setting Range  Waveform Report "12-Lead > 12-Lead Auto Record > Print/PDF (Without FP- Yes, [No] 908A)" P13-39 Report Format 3ch x 4+Rhythm 1ch, [6ch x 2+Rhythm 1ch] Results Report Yes, [No]...
  • Page 317 Chapter 13 Settings 12-Lead Examinations 12-Lead > 12L Review Rec. > Print/PDF Setup Item Description Setting Range  "12-Lead > 12-Lead Auto Record > Print/PDF (With FP-908A)" P13-39)  "12-Lead > 12-Lead Auto Record > Print/PDF (Without FP-908A)" P13-39) 12-Lead > 12L Review Rec.> DICOM Setup Item Description Setting Range...
  • Page 318 Chapter 13 Settings 12-Lead Examinations 12-Lead > 12L Copy Recording > Print/PDF Setup Item Description Setting Range  "12-Lead > 12-Lead Auto Record > Print/PDF (With FP-908A)" P13-39)  "12-Lead > 12-Lead Auto Record > Print/PDF (Without FP-908A)" P13-39) Extended Recording 12-Lead >...
  • Page 319 Chapter 13 Settings 12-Lead Examinations 12-Lead > Extended Recording > Arrhythmia (Without FP-908A) Setup Item Description Setting Range Arrhythmia Lead Specify 3 ch examination lead. [II, aVF, V5] I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V1R, V2R, V3R, V4R, V5R, V6R, V7R, V8R, V9R Waveform Report...
  • Page 320 Chapter 13 Settings Arrhythmia Examinations Arrhythmia Examinations Set the items for arrhythmia examinations. General Arrhythmia Examination > General > General (With FP-908A) Setup Item Description Setting Range Lead Specify examination lead. [II, aVF, V5] I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V1R, V2R, V3R, V4R, V5R, V6R, V7R, V8R, V9R...
  • Page 321 Chapter 13 Settings Arrhythmia Examinations Arrhythmia Examination > General > General (Without FP-908A) Setup Item Description Setting Range Lead Specify examination lead. [II, aVF, V5] I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V1R, V2R, V3R, V4R, V5R, V6R, V7R, V8R, V9R Anonymous...
  • Page 322 Chapter 13 Settings Arrhythmia Examinations Auto Recording Arrhythmia Examination > Auto Recording (With FP-908A) Setup Item Description Setting Range Duration Specify the waveform recording duration. When the specified 40 sec, 1 min, 2 min, [3 min], duration elapse, the recording will automatically stop. 100 bts, 200 bts Sensitivity Specify the sensitivity for reading files.
  • Page 323 Chapter 13 Settings Arrhythmia Examinations Arrhythmia Examination > Print/PDF (Without FP-908A) Setup Item Description Setting Range Waveform Report Specify whether or not to output the waveform report. [Yes], No Rhythm Measurement Specify whether or not to output the rhythm measurement report. [Yes], No Report Detailed Measurement Specify whether or not to output the detailed measurements...
  • Page 324 Chapter 13 Settings Rhythm Measurements Rhythm Measurements Configures items for rhythm measurements. General Rhythm Meas. > General > General (With FP-908A) Setup Item Description Setting Range Lead Specify examination lead. [II], I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V1R, V2R, V3R, V4R, V5R, V6R, V7R, V8R, V9R Anonymous...
  • Page 325 Chapter 13 Settings Rhythm Measurements Rhythm Meas. > General > General (Without FP-908A) Setup Item Description Setting Range Lead Specify examination lead. [II], I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V1R, V2R, V3R, V4R, V5R, V6R, V7R, V8R, V9R Anonymous Specify whether or not to make patient information anonymous.
  • Page 326 Chapter 13 Settings Rhythm Measurements Auto Recording Rhythm Meas. > Auto Recording Setup Item Description Setting Range Duration Specify the waveform recording duration. When the specified [1 min], 40 sec., 1 to 10 minutes, duration elapse, the recording will automatically stop. 100 beats, 200 beats Waveform Report Specify whether or not to output the waveform report.
  • Page 327 Chapter 13 Settings Post-Exercise Examination Rhythm Meas. > Freeze (With FP-908A) Freeze Result Display Specify whether or not to display the freeze/result display. [Same with Exam. Result], No, Same with Result Display: The result display will be according to the setting under [General>Display>Display Result]. No: Results are not displayed.
  • Page 328 Chapter 13 Settings Post-Exercise Examination General Post-Exercise > General > General Setup Item Description Setting Range Check Lead-off Specifies whether to stop recording if lead-off occurs during [Yes], No recording. Anonymous Specify whether or not to make patient information anonymous. Report Only, Display Only, Both, [No] Bold Print...
  • Page 329 Chapter 13 Settings Post-Exercise Examination Freeze Post-Exercise > Freeze Setup Item Description Setting Range  "12-Lead > Freeze (With FP-908A)" P13-31)  "12-Lead > Freeze (Without FP-908A)" P13-32) Filter Post-Exercise > Filter Setup Item Description Setting Range  "12-Lead > Filter" P13-32) 12-Lead Manual Recording Post-Exercise >...
  • Page 330 Chapter 13 Settings Post-Exercise Examination Post-Exercise > Rest (Auto Rec.) > 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 Sensitivity 1 sensitivity of 1 cm/mV, its lead block will be recorded again with auto sensitivity.
  • Page 331 Chapter 13 Settings Post-Exercise Examination Post-Exercise > Rest (Auto Rec.) > Print/PDF (With FP-908A) Setup Item Description Setting Range Waveform Report Specify whether or not to output the waveform report. Yes, [No] Report Format Specify the type of ECG waveform recording for 12-lead 3ch x 4, 3ch x 4+Rhythm 1ch, 3ch recording.
  • Page 332 Chapter 13 Settings Post-Exercise Examination Post-Exercise (Auto Recording) Post-Exercise > Post (Auto Rec.) Setup Item Description Setting Range  "Post-Exercise > Rest (Auto Rec.) > General" P13-54)  "12-Lead > 12-Lead Auto Record > Waveform Report (With FP-908A)" P13-36)  "12-Lead >...
  • Page 333 Chapter 13 Settings Post-Exercise Examination Post-Exercise (Periodic Recording) Post-Exercise > Post (Periodic) > 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 Sensitivity 1 sensitivity of 1 cm/mV, its lead block will be recorded again with auto sensitivity.
  • Page 334 Chapter 13 Settings Post-Exercise Examination recording will be ignored. Post-Exercise > Post (Periodic Rec.) > Auto Extend Setup Item Description Setting Range  "Post-Exercise > Rest (Auto Rec.) > Auto Extend (With FP-908A)" P13-54) Post-Exercise > Post (Periodic Rec.) > Print/PDF Setup Item Description Setting Range...
  • Page 335 Chapter 13 Settings 15-Lead Examinations 15-Lead Examinations Set the items for 15-lead examinations. General 15-Lead > General > General Setup Item Description Setting Range  "Post-Exercise > General > General" P13-52) 15-Lead > General > Lead Setup Item Description Setting Range Lead Setting Specify the leads for conducting examinations.
  • Page 336 Chapter 13 Settings 15-Lead Examinations 15-Lead > General > Result (With FP-908A)  Display Result "12-Lead > General > Result (With FP-908A)" P13-27) Result Display Order Save results report Waveform Display Phase Result Display Same Date for Comparison ST Display* Plot measurement* 15-Lead >...
  • Page 337 Chapter 13 Settings 15-Lead Examinations 15-Lead > General > File (With FP-908A) At Analysis Error Specify whether to save analysis results when analysis result [Cancel], Continue error occurs. Confirmation to Save Specify whether or not to display the save confirmation window [Yes], No (During recording) during recording by interval.
  • Page 338 Chapter 13 Settings 15-Lead Examinations 15-Lead > Freeze (With FP-908A) Results to be made Specify the analysis results when using the freeze function. [15-Lead Analysis Result], Multiple items can be specified. Arrhythmia Analysis, Rhythm Measurement 15-Lead > Freeze (Without FP-908A) Setup Item Description Setting Range...
  • Page 339 Chapter 13 Settings 15-Lead Examinations 15-Lead > 15L Manual Rec. > 15L Manual Rec. (Without FP-908A) Setup Item Description Setting Range Recording Channels Specify the number of channels for 15-lead manual recording. 3ch, [6ch], 12ch, 15ch  Adjust Recording Position ( "12-Lead >...
  • Page 340 Chapter 13 Settings 15-Lead Examinations 15-Lead > 15L Manual Rec. > Results Report (With FP-908A) Setup Item Description Setting Range Results Report Specify whether or not to output the results report. [Yes], No Report Format Specify the results report format. Cover, [DOM1], Cover: Prints patient information and interpretation.
  • Page 341 Chapter 13 Settings 15-Lead Examinations 15-Lead > 15L Manual Rec. > Results Report (Without FP-908A) Setup Item Setup Setting Range Results Report Specify whether or not to output the results report. [Yes], No Report Format Specify the results report format. Cover, [DOM] Cover: Prints patient information and MEMO section.
  • Page 342 Chapter 13 Settings 15-Lead Examinations 15-Lead > 15L Auto Rec. > Waveform Report (Without FP-908A) Report Format Specify the format for 15-lead recording. 3ch x 5, 3ch x 5+Rhythm 1ch, 3ch x 5+Rhythm 2ch, [6ch x 2+3], 6ch x 2+3ch+Rhythm 1ch, 15ch Waveform Type Specify the type of waveform report to output.
  • Page 343 Chapter 13 Settings 15-Lead Examinations 15-Lead > 15L Review Rec. > Print/PDF, DICOM Setup Item Description Setting Range  "15-Lead > 15L Auto Rec.> Print/PDF, DICOM" P13-66) 15-Lead Copy Recording 15-Lead > 15L Copy Rec. > General Setup Item Description Setting Range Auto Sensitivity System Specify the automatic sensitivity method.
  • Page 344 Chapter 13 Settings 15-Lead Post-Exercise Examinations Extended Recording 15-Lead > Extended Recording > General Setup Item Description Setting Range Extended Recording Specify the extended recording details. Rhythm Meas. 1 min., Rhythm Meas. 3 min., [Arrhythmia 40 sec]., Arrhythmia 1 min., 15-Lead Record Start Position Specify the start position for extended recording.
  • Page 345 Chapter 13 Settings 15-Lead Post-Exercise Examinations General 15-Lead Post-Exercise > General Setup Item Description Setting Range  "Post-Exercise > General > General" P13-52)  "15-Lead > General > Lead" P13-59)  "15-Lead > General > Result (With FP-908A)" P13-59)  "15-Lead >...
  • Page 346 Chapter 13 Settings 15-Lead Post-Exercise Examinations Rest (Auto Recording)/Post (Auto Recording) 15-Lead Post-Exercise > Rest (Auto Rec.), Post (Auto Rec.) Setup Item Description Setting Range  "Post-Exercise > Rest (Auto Rec.) > General" P13-54)  "15-Lead > 15L Auto Rec. > Waveform Report (With FP-908A)" P13-65) ...
  • Page 347 Chapter 13 Settings Confirming Technique Quality Control/Device Quality Control Confirming Technique Quality Control/Device Quality Control Switching to quality control mode makes it possible to save 12-lead analysis measurement data while performing daily quality control. It is possible to confirm the settings for saving measurement data in quality control mode in the "Technique QC" and "Device QC"...
  • Page 348 Chapter 13 Settings Enhanced ECG 12-Lead Manual Recording Enhanced ECG > 12L Manual Rec. Setup Item Description Setting Range  "12-Lead > 12L Manual Rec. > 12L Manual Rec. (With FP-908A)" P13-33)  "12-Lead > 12L Manual Rec. > 12L Manual Rec. (Without FP-908A)" P13-33) ...
  • Page 349 Chapter 13 Settings Enhanced ECG Extended Recording Enhanced ECG > 12L Review Rec.> General Setup Item Description Setting Range  "12-Lead > Extended Recording > General" P13-42)  "12-Lead > Extended Recording > Arrhythmia (With FP-908A)" P13-42)  "12-Lead > Extended Recording > Arrhythmia (Without FP-908A)" P13-43) ...
  • Page 350 Chapter 13 Settings Rearranging the Examination Selection Window Rearranging the Examination Selection Window The examinations displayed on the "Select Examination" window can be rearranged as necessary. It is also possible to register a new examination. Touch [Menu] - [Register Examination]. Change the display position.
  • Page 351 Chapter 13 Settings Rearranging the Examination Selection Window Add a new examination. A newly registered examination can be selected in the "Select Examination" window in the same way as other examinations. Touch the [Create New Exam.] tab. Touch the entry area of the New name. The examination name entry window will appear. Enter the name of the new examination and touch [ Touch the examination to use as the base.
  • Page 352 Chapter 13 Settings Rearranging Functions Keys on the Examination Screen Touch the entry area of the Name. The examination name entry window will appear. Enter the name of the examination and touch [ Touch the examination to copy. After completing configuration, touch [ ].
  • Page 353 Chapter 13 Settings Saving and Printing the Settings This allows to use the selected functions in each examination. REFERENCE  To revert back to the default layout for the function keys, touch [Reset] in the setting screen of each examination's function keys. Saving and Printing the Settings It is possible to save the current settings to an SD card or DMS, or to print them to recording paper.
  • Page 354 Chapter 13 Settings Saving and Printing the Settings To cancel printing, press the (START/STOP) key. 13-78...
  • Page 355 Please note that Fukuda Denshi may not be held liable for accidents resulting from a failure to perform maintenance and inspection tasks. Fukuda Denshi may offer technical explanations in the form of service guides and so on in response to requests from contracted service personnel (repair personnel).
  • Page 356 Chapter 14 Maintenance and Inspection Daily Inspections Daily Inspection List  Appearance Visually perform the following inspections. Item Inspection Details Procedure Judgment Criteria Main Unit 1) Exterior of main unit Check that flaws, cracks, deformation and No exterior flaws, cracks, deformation or rust are not found on the main unit.
  • Page 357 Chapter 14 Maintenance and Inspection Periodic Inspections Periodic Inspections The periodic inspections should be performed by service personnel according to the following "Periodic Inspection Procedure".  Perform inspections as described in the Periodic Inspection Procedure at least once a year. ...
  • Page 358 Chapter 14 Maintenance and Inspection Periodic Inspections  Mechanical Inspection Actually operate the mechanisms and inspect them. Item Inspection Details Procedure Judgment Criteria Main Unit 1) Key Check that the key operates smoothly. Smooth operation 2) Printer Check that operations are smooth and that Smooth operations and no abnormal there is no abnormal sound.
  • Page 359 Chapter 14 Maintenance and Inspection Periodic Inspections  Maintenance Test REFERENCE  To enter maintenance mode, touch [Menu] - [Maintenance] on the examination screen. Item Inspection Details Procedure Judgment Criteria Performance 1) Clock confirmation Touch [Set Date/Time] in the maintenance Displays the current time menu screen 2) Thermal printing test...
  • Page 360 The descriptions relating to these test items assume the use of a special electrical safety instrument that is subjected to quality control. In order to simplify testing and secure accuracy, it is recommended to use a dedicated safety measurement instrument. For details regarding safety testing instruments, contact your local Fukuda Denshi service representative.  Inspected Items Electrical safety inspection items come in the following categories.
  • Page 361 Chapter 14 Maintenance and Inspection Inspecting Electrical Safety  Maximum Allowable Leakage Current Leakage Current Type B Type BF Type CF (Units: mA) Normal Single fault Normal Single fault Normal Single fault Condition Condition Condition Earth leakage current Touch current Direct 0.01 0.05...
  • Page 362 Chapter 14 Maintenance and Inspection Inspecting Electrical Safety Touch Current 1. Measurement wiring diagram Allowable value Normal Condition Single Fault Condition 0.1 mA 0.5 mA Patient Leakage Current (from patient connection to earth) 1. Measurement wiring diagram Patient Applied Part (Patient Cable, CP-105J, etc.
  • Page 363 If the fan stops spinning, the internal temperature of the device will increase, and the power will automatically shut off. If the device repeatedly turns off automatically during AC operation, the cooling fan may be faulty, or there might be dust or some other substance blocking the vent. Contact your local Fukuda Denshi service representative. 14-9...
  • Page 364 Chapter 14 Maintenance and Inspection Cleaning and Disinfecting Cleaning and Disinfecting Cleaning the Main Unit  Cleaning Apply disinfecting alcohol (ethanol or isopropyl alcohol) to a piece of gauze or absorbent cotton, wring it out thoroughly and wipe. Next, wipe it dry with a piece of cloth. Types of cloth that can be used: ...
  • Page 365 CAUTION  Never use sandpaper as it will damage the heating element.  Contact your local Fukuda Denshi service representative to have the thermal head cleaned.  Cleaning the Touch Panel Since the display part is used as a touch panel, it can easily be smudged with fingerprints and other dirt.
  • Page 366 If the operating time is extremely short in spite of the fact that the battery pack is fully recharged, replace it with a new pack. Contact your local Fukuda Denshi service representative in order to purchase a new battery pack or when it is the scheduled replacement time.
  • Page 367 Chapter 14 Maintenance and Inspection Modifying the Time and Date Modifying the Time and Date Touch the following in this order: [Menu]-[Maintenance]-[Set Date/Time]. Confirm that the time and date are accurate.  if they are, go to step 5. To correct them, go to step 3. To change the time and date, touch [Set Date/Time].
  • Page 368 Chapter 14 Maintenance and Inspection Modifying the Time and Date 14-14...
  • Page 369 Chapter 15 Appendix Specifications Chapter 15 Appendix Specifications The specifications of the device are as follows. REFERENCE  For quality improvement purposes, specifications may be subjected to change without prior notice.  Displaying an inoperable ECG A notification is displayed if any amplifier becomes inoperable due to overload or saturation Lead identification, lead names and definitions In a rectangular coordinate system, with time increasing in the positive x...
  • Page 370 Chapter 15 Appendix Specifications Using a Pacemaker Distortion: 70% recovery of 1 mVp-v takes 50 ms or less, 10 mm or less baseline accumulation change, 20% or less amplitude attenuation of triangular waves, able to clearly recognize triangular waves and pacemaker pulses Visibility: 2 mm or greater Requirements of Filters...
  • Page 371 Chapter 15 Appendix Specifications  Wireless LAN Used Frequency Band 2.4 GHz, 5 GHz Supported Standard IEEE802.11a/b/g/n/ac Modulation Mode Direct spread DSSS, CCK Orthogonal frequency-division multiplexing OFDM Effective Power 17.5 dBm and below  Bluetooth (FX-9800) Used Frequency Band 2.402 to 2.480 GHz Conforming Standard Bluetooth 4.1 Modulation Mode...
  • Page 372 Chapter 15 Appendix Specifications  Transport/Storage Environment (FX-9800 and Recording Paper, Internal Battery, Accessories other than Keratin Cream, and Optional Accessories) Temperature -10°C to +60°C Humidity 10% to 95% (absolute humidity of 40°C 95%RH or less, non-condensing) Atmospheric Pressure 80 kPa to 106 kPa ...
  • Page 373 Chapter 15 Appendix System Components System Components NOTE  To satisfy the intended performance of the product, use only the specified consumables.  When placing an order, specify the item name and model type.  For quality improvement purposes, specifications may be subjected to change without prior notice.
  • Page 374 Chapter 15 Appendix System Components  Other Medical Devices Item Model Type Note Electrode 3M 2330 Required patient cable: CME-77 series for wired patient cable CME-03 series for CIE-01B  Other Products Item Model Type Note USB Memory Swissbit SFU34096C1AE2TO-C- GE-1AP-STD Barcode Reader Zebra DS2208...
  • Page 375 Room used for other Patient Environment purposes than diagnosis Patient Environment List of System Equipment Item Model [Outside a Patient Environment] Personal computer Ethernet hub External display EV2460-BK *Contact your local Fukuda Denshi service representative for the usable models. 15-7...
  • Page 376 Chapter 15 Appendix Check List Check List  Daily Check List [FX-9800] Item Check Item Procedure and measurement value, Judgment Note criteria (Repair required) Appearance External Exterior flaws, cracks, Check that flaws, cracks, deformation OK/NG Appearance deformation, rust and rust are not found on the main unit. Peeling or dirt on the label or Check that peeling or dirt is not found on OK/NG...
  • Page 377 Chapter 15 Appendix Check List  Daily Check List [EE-50] Item Check Item Procedure and measurement value, criteria Judgment Note (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 or dirt on the label or No dirt.
  • Page 378 Chapter 15 Appendix Check List  Daily Check List [EE-51] Item Check Item Procedure and measurement value, criteria Judgment Note (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 or dirt on the label or No dirt.
  • Page 379 Chapter 15 Appendix Check List  Periodic Check List [FX-9800] Item Check Item Procedure and measurement value, criteria Judgment Note (Repair required) Appearance External Exterior flaws, cracks, Check that flaws, cracks, deformation and rust OK/NG Appearance deformation, rust are not found on the main unit. Peeling or dirt on the label or Check that peeling or dirt is not found on the label OK/NG...
  • Page 380 Chapter 15 Appendix Check List Maintenance Backup Battery Backup battery voltage of 2.5 V or greater OK/NG Clock setting Check that correct time is displayed. OK/NG Printing Test Check that the printing paper is fed straight. OK/NG Check that both sides of the printing paper are not creased.
  • Page 381 Chapter 15 Appendix Check List Item Check Item Procedure and measurement value, criteria Judgment Note (Repair required) Other Power Supply Check that both AC power and rechargeable OK/NG battery power can be turned on/off. Power Supply Cable Perform a continuity test using a tester and OK/NG check that the device is conducting.
  • Page 382 Chapter 15 Appendix Check List  Periodic Check List [EE-50] Item Check Item Procedure and measurement value, criteria Judgment Note (Repair required) Appearance External Exterior flaws, cracks, deformation, Check that flaws, cracks, deformation and OK/NG Appearance rust rust are not found on the main unit. Dirt No dirt.
  • Page 383 Chapter 15 Appendix Check List  Periodic Check List [EE-51] Item Check Item Procedure and measurement value, Judgment Note criteria (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. Dirt No dirt.
  • Page 384 Chapter 15 Appendix Glossary Glossary  Terms Relating to Recording Basic Waveform Measurement Average of detailed waveform measurement Detailed Waveform Measurement Dominant waveform measurement of each lead Basic Arrhythmia Measurement Average of detailed arrhythmia measurement Detailed Arrhythmia Measurement Raw waveform (I, II, V2, V5) measurement of each heart rate ...
  • Page 385 Chapter 15 Appendix Glossary  Detailed Measurement Detailed measurements are printed on the detailed measurement report and displayed on the detailed measurement screen. P1 amplitude of detailed waveform measurement P2 amplitude of detailed waveform measurement Q amplitude of detailed waveform measurement R amplitude of detailed waveform measurement S amplitude of detailed waveform measurement R' amplitude of detailed waveform measurement...
  • Page 386 Chapter 15 Appendix Glossary R’a S’a R’d S’d 15-18...

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Fx-9800