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01
THE PERSONS RESPONSIBLE FOR PLACING DEVICES ON THE EC MARKET UNDER MDD
93/42/EEC
NAME : FUKUDA DENSHI UK
ADDRESS : 13 WESTMINSTER COURT, HIPLEY STREET OLD WOKING, SURREY GU22 9LG, U.K.
CAUTION
Only physician or persons instructed by physicians are allowed to use the equipment.
The information contained in this document is subject to change without notice due to improvement in the
equipment.
No part of this document may be copied or transmitted in any form without the prior written permission of
Fukuda Denshi Co., Ltd.
※If this manual has pages missing or is out of order, contact Fukuda Denshi for replacement.
Copyright ©, 2007, Fukuda Denshi Co., Ltd.
i
Ⅰ.Introduction
Thank you for purchasing the ECG Filing Software, EFS-200.
The ECG Filing Software, EFS-200 (hereinafter referred to as EFS-200) is a software program
which operates under the Windows XP environment.
As all other Windows application, the EFS-200 is operated using the Windows GUI (Graphical
User Interface).
Before using this software, read this “Operation Manual” thoroughly to fully understand the
operation procedure.
Safety Precautions
Read the “Safety Precautions” thoroughly before use to ensure correct and safe use of the
product.
Be sure to follow the precautions indicated below, as these are important messages related to
safety.
The following is a description of the safety and precaution messages used in this manual.
Safety Notifications: The following safety notification classifies the extent of danger and damage
caused by not following the instruction.
Graphic Symbols: The symbols listed below are used to categorize the types of instruction
included in this manual.
CAUTION
● Do not change or delete the setup file or data file in the EFS-200 using the
function other than the one provided for the EFS-200.
The inconsistency of the data management may cause the registered data to be
initialized or may cause malfunction of the EFS-200.
● Read carefully the safety precautions in the operation manual provided for
each device, and make sure that the device is used correctly.
● Please note that Fukuda Denshi is not liable of the damage caused by the
erroneous operation of the user.
● Please note that Fukuda Denshi is not liable of the damage resulting from the
use of this software with the device.
Networks used for other purpose such as for host computer cannot be used.
NOTE ● The information contained in this “Operation Manual” may change without
prior notice.
● This “Operation Manual” was made with utmost care, but if there is any
questionable point, misprint, or undocumented point, contact Fukuda
Denshi.
● Some types of ECG data are not supported on the EFS-200. For details,
refer to Fukuda Denshi sales representative.
CAUTION
● Before use, always check that the device operates normally and safely.
● Do not insert the IC card the wrong way, into unspecified slot, or push in
with excessive force.
● Do not insert the floppy disk in the opposite direction, into unspecified slot,
or push in with excessive force.
It may damage both the main unit and the floppy disk.
Introduction・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・i
I General Description
II Install Process
IV Operation Procedure
Appendix
Appendix-1 Troubleshooting・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・P. 62
I. General Description
I-1. General Description
The EFS-200 is a software program, which manages the inspection data saved on the Fukuda
Denshi electrocardiograph.
Online connection via FTP with Fukuda Denshi electrocardiograph allows speedy recording.
The data stored on the electrocardiograph recording media can be also recorded on the EFS-200.
From the recorded data, the data can be quickly searched to perform process such as over read,
time-serial comparison, etc.
The infrequently used past data can be saved on a removable disk to be used when necessary.
Clear information is provided not only on the display, but also on the printout of various formats.
1) OS :
Windows XP (※1)
2) Memory :
256MB or above
3) Resolution XGA (1024 ´ 768 dot) or above, High Color (16 bit) or above (※2)
:
4) HDD :
Open space, 20GB or above (※3)
5) FDD :
2 mode type (※4)
6) PCMCIA :
Card device which is compatible with the PCMCIA / CF card used by the
Fukuda Denshi electrocardiograph. (※5)
7) Storage Media : Removable device which can be acknowledged on the Windows. (※5)
8) Printer : Paper size A4 or letter
Resolution 600 DPI or above
※2 ・ If 256 colors or less is used, the grids may not be properly displayed.
・ Operation on SVGA: 800´600 dot resolution is not guaranteed.
・ For ECG and other waveform data display, SXGA (1280´1024), High
Color (16 bit) or above is recommended.
・ On the XGA (1024´768) display, if “Large size (120 DPI)” is set for DPI
setting, some dialogue may not fit in the display. In such case, select
“Normal size (96 DPI)”.
※3 The ECG data will be registered to the specified folder of the EFS-200.
NOTE ・ The number of data that can be stored differs according to the HDD
capacity.
・ One ECG data size is approximately 30KB.
● A continuous use of the EFS-200 by the same user for long period of
time should be avoided.
2. On the “Start” menu, click “Run…” and select the SETUP.EXE from the EFS-200 software,
then click “OK”.
※ When the EFS-200 is installed for the first time, it is necessary to start the EFS-200.
※ By starting the EFS-200, it will be correlated to the extension file. (.ECG)
[Start/Programs Menu]
3) From the install program list, select “ECG Filing Software EFS-200”.
4) Click Change / Remove .
5) Click Yes .
★ When the program is uninstalled, the following folders and files created during the
installation process will be deleted.
・ Install folder
・ Desktop folder [ECG Filing Software EFS-200]
NOTE ・ Desktop shortcut [ECG Filing Software EFS-200] (※ If created.)
★ As the “Data Registration Folder” is assigned inside the install folder by default, it will
be deleted when the uninstall procedure is performed.
2. On the “Start” menu, click “Run…” and select the SETUP.EXE from the EFS-200 software
then click “OK”.
Please make sure to back up the data folder (See IV-11-1. Backup of
CAUTION Registered Data) before starting the upgrade. Otherwise you will lose all your
data!
Upgrade installation on a computer with the same or a higher software version cannot be
NOTE
executed. Please make sure of your current software level.
NOTE
1) Go to Set up.
2) Then Options.
Right-click Menu
Data Registration Folder
Capacity
On the EFS-200, the operation can be performed from “Menu”, “Tool Button”, or “Right-click Menu”.
NOTE ※Make sure that there is sufficient open space on the “Data Registration Folder”.
3. Switch language.
To change the language, click Language .
2) Click OK .
Reference
・To sort the select data list in the date/time
descending order, select “Common” for
waveform condition, and put a check mark for
“Sort by date and time”.
・If not checked, the data will be sorted in the
ascending order.
2) Click OK .
2) Click OK .
Reference
To display the name for each item, it is
necessary to set the same table with the
electrocardiograph.
4) Click Update .
★ When searching a data, select the user name from this table before starting the
search process.
NOTE ★ When over read process is performed, the over read executor will be the user
selected on this table.
● Select “Register Data” from the “Registration” menu, or click “Register Data” tool button to start the
offline registration process.
2) Click FD recognition .
4) Click Registration .
★ Depending on the electrocardiograph type, the floppy disk with the capacity of
NOTE 1.2MB may be used.
However, for the EFS-200, only the floppy disk with the capacity of 1.44MB
can be used.
4) Click Registration .
NOTE ★ It is necessary to preprogram the IC card drive on the drive setup menu.
● To individually register the ECG file, select “File specification” → “File read” from the
“Registration” menu.
4) Click Registration .
NOTE ★ Maximum of 2,000 data can be registered at once for collective registration.
● Select “Search data” from the “File/Edit” menu, or click “Search” tool button.
2) Click Search .
[ Next ] [ Previous ]
Reference
・To sort the select data list in the date/time
descending order, select “Common” for
waveform condition, and put a check mark
for “Sort by date and time”.
・If not checked, the data will be sorted in the
ascending order.
★ The sorting of select data list is effective only for the currently displayed list.
NOTE The next time the select data list is displayed, the data will be sorted according
to the sort selection for the search data condition.
1) Select the data from the list, and click Select data .
★ The additionally searched data is effective only for the time- serial comparison.
NOTE ★ To display the past inspection result individually, specify the “ID Number” on the
standard search function.
3. For “Compare two data” mode, click the waveform display part to compare the waveforms.
4. For “Compare four data” mode, “Side by side” or “Overlap” display can be selected.
2. The test history for the currently displayed patient (same ID no.) will be displayed.
1) The inspected data of the last 6 months classified by the inspection type will be displayed.
2) The displayed numbers are the number of inspection days within the month.
● Select “Print report” from the “File/Edit” menu, or click “Print report” tool button.
※ The waveform report format can be specified on the print setting menu.
2) Click Update .
2. Over Read
● The displayed over read menu will differ depending on the inspection type.
a) 12-Lead / Arrhythmia
1) Editing standard measurements, “Grade”, “Stress”
・Stress Select the stress. Left-click ▼ to display the selection in the drop-down box.
(This selection is possible only if the inspection type is “at rest”.)
・Delete data Select the code to delete, and click Delete data .
Reference
The codes on the list cannot be completely deleted. If Delete data is clicked for the last
code on the list, it will be replaced with normal code (101 Within Normal Limits).
・Delete data Select the code to delete, and click Delete data .
Reference
The codes on the list cannot be completely deleted. If Delete data is clicked for the last
code on the list, it will be replaced with normal code (101 Within Normal Limits).
4) Click To normal to correct the findings information to normal code (101 Within Normal Limits).
A confirmation message will be displayed.
・Click Yes to correct to normal code.
・Click No to cancel the process.
6) Click Update to validate the corrected items and end the OR process.
7) Click Cancel to invalidate the corrected items and end the OR process.
2) Click Update to validate the corrected items and end the OR process.
3) Click Cancel to invalidate the corrected items and end the OR process.
3. “OR OK”
To make the currently displayed data as “OR OK”, follow the procedure below.
● The EFS-200 is provided with the following output function, “Output image”, “Output ECG data to FD”,
“SCP-ECG data output”.
● The setup such as “Output CSV format data with image”, “Create new file name” can be performed for
the output image.
1) By putting a check mark for “Output CSV format data with image”, the data information in CSV format
will be simultaneously output with the image.
2) By putting a check mark for “Create new file name”, image file (if image is created) will be automatically
created in the file output folder.
● The output image file name will be automatically created with the following rule.
[Type]
[Inspection Date]
YYYYMMDD Format Ex.) Nov. 11, 2003 à 20031101
[Inspection Date]
HHMMSS Format Ex.) 09 (hr): 10 (min.): 21 (sec.) à 091021
★ The inspection date format will be according to the “Date type” selection for
NOTE the “Options” setting (IV-1-1).
● Click “Output image” on the “Output” menu, or click “Output image” tool button.
2) Click Save .
★ If “Create new file name” is checked for “Output image” (“Setup” → “Options”),
NOTE the image file will be automatically created.
◆ The EFS-200 data will be written to the floppy disk as an additional data.
2) Click Save .
◆ The folder which will be displayed at output can be set on the drive setup menu.
◆ The data can be output with the information such as “ID”, “Name”, “Comment”, “Ward1” excluded.
The information to not include in the output data can be selected on the “Output settings” window.
● Select “Clipboard” from the “Output” menu to copy the currently displayed screen to the
clipboard.
● On the enlarged waveform display, click Copy to copy the display to the clipboard.
Reference: The image copied to the clipboard can be pasted and used on other application.
On the data selection list, the data with the “Recycle Bin” icon is the deleted data.
◆ The backup process will copy the stored data of the EFS-200 to the specified “Backup Folder”.
◆ A sufficient space is required for the backup folder.
◆ To use the backup function, it is necessary to specify the “Backup Folder” on the operation
environment setup.
2) Click Start .
◆ To transfer the registered data of the EFS-200 from the “Data Registration Folder” to another drive.
◆ When there is no more space on the hard disk, use this function to transfer the data in the “Data
Registration Folder” to MO disk, etc.
◆ To view the transferred data, change the “Data Registration Folder” setting to the transferred drive, and
search the data.
2) Click Execute .
4) Click OK .
6) Click OK .
Displays the
connection process
with the
electrocardiograph.
Displays operation
process, error, etc.
★ This connection process will function only on the PC which the EFS-200 operates.
★ If error is generated during registration, ERR_DATA folder will be created under the
File Read Folder set at “Options” setting, and stores the ECG data file.
NOTE The file name will be created by adding recorded date/time to the registered file
name.
Ex) If the registered file name is TEST.ecg, recorded date is Aug. 31, 2006, and
recorded time is 18:08:26, the file name will be as follows;
TEST_20060831180826.ecg
1) Double-click “Network
Connections” on the control panel.
3) Click “OK”.
★ The IP address set here will be used as “Host IP Address” on the connected
electrocardiograph.
For the setup on the electrocardiograph, refer to the operation manual of the
electrocardiograph.
★If “Obtain an IP address automatically.” is set for the DHCP server (including rooter,
etc.), change the setting to “Use the following IP address”.
Assign a fixed IP address which will not duplicate with the IP address assigned by
the DHCP server (including rooter, etc.).
If the adjustment with the DHCP server (including rooter, etc.) is required, consult
with your network administrator, or refer to the operation manual of the DHCP server
and rooter.
2. The install process for the selected component will start, and after a while, a confirmation
message to end the process will be displayed.
2. Click the computer icon displayed at left, and display the “FTP Sites”.
1. Right-click the “FTP Sites”, select “Properties”, and open the “FTP Sites Properties” window.
Click the “Security Accounts” tab.
Appendix-1 Troubleshooting
General
・ Check if all the power of the PC, peripheral device, etc. are turned ON.
After checking the above, reset the power.
If the system still does not start, contact our service representative.
・ Some kind of error has generated to the device. (CPU overheat, etc.)
Contact our service representative.
・ On the EFS-200, more than one execute files refer the same file.
If the process fails after retrying for several times, the EFS-200 may stop operating.
In such case, restart the system.
Connection failure between the electrocardiograph and EFS-200 system has occurred.
・ Check the LAN cable connection. Verify that the cable is securely connected.
Waveform Display
・ Click “Search data” from the “File/Edit” menu, and open the search condition setup window.
・ Put a check mark for “Includes deleted data”, and click Search .
・ Select the data you wish to recover, and click “File/Edit” → “Data delete/Recovery” → “Recovery data”.
(⇒IV-10-2)
Off-line Registration
Error has generated when reading the recorded data from the floppy disk.
・ Check if the drive which the floppy disk is inserted and the drive specified on the EFS-200 is corresponded.
Specify the correct drive on the EFS-200, and continue the process.
・ The electrocardiograph of the recorded data or the recorded data type is not supported on the EFS-200.
Contact our service representative.
Printing
・ If the printer error (alarm) is generated, follow the procedure on the operation manual of the printer, and
resolve the problem.
・ Clean inside the printer by following the procedure explained in the operation manual of the printer.
★ If the above occurs during printing, shake the toner cartridge 4 or 5 times to
even out the toner. This may temporarily improve the situation. But, as this
is a temporal procedure, make sure to replace the toner cartridge as soon as
NOTE possible.
Suddenly, the printing speed became slow, or the printing output is garbled.
・ If no problem is found on the connection or on other device, the printer control of the Windows may be
malfunctioning.
・ Clear the printer buffer of the Windows, and reset the power of the printer.
NOTE
If trouble persist, contact our service representative.
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03/10 2004 9:32:40 REST-ECG ID: 000081018624 65years Female Hanako Fukuda
Ward1 : HR= 68bpm 504 CRBBB(Complete Right Bundle Branch Block) 7-2
Ward2 : R-R=0.870s
Medicati: P-R=0.149s
QRS=0.140s
Symptom :
QT =0.403s
QTc=0.432
AXIS= 34Deg
[OR]EFS-200 SV1=0.16mV
RV5=0.88mV
R+S=1.04mV Borderline Abnormal Stress - Caution
Comment:
03/10 2004 9:38:15 Post stress[ 1'02] ID: 000081018624 65years Female Hanako Fukuda
Ward1 : HR= 82bpm 504 CRBBB(Complete Right Bundle Branch Block) 7-2
Ward2 : R-R=0.731s 901 Exercise Test (-) 4-5 ;L V5 ,V6
Medicati: P-R=0.126s
QRS=0.127s
Symptom :
QT =0.362s
QTc=0.423
AXIS= 59Deg
>>>Unconfirmed report <<< SV1=0.21mV
RV5=1.10mV
R+S=1.31mV Master TestDouble 40/40 times
Comment:
03/10 2004 9:40:13 Post stress[ 3'00] ID: 000081018624 65years Female Hanako Fukuda
Ward1 : HR= 77bpm 504 CRBBB(Complete Right Bundle Branch Block) 7-2
Ward2 : R-R=0.775s 901 Exercise Test (-)
Medicati: P-R=0.130s
QRS=0.133s
Symptom :
QT =0.393s
QTc=0.446
AXIS= 38Deg
>>>Unconfirmed report <<< SV1=0.17mV
RV5=0.90mV
R+S=1.07mV Master TestDouble 40/40 times
Comment:
03/10 2004 9:56:49 Rhythm ECG ID: 000085017630 62years Female Aiko Fukuda
Ward1 : Test Mode:3 min
Ward2 : Test body position:
Medicati: RECORDING LENGTH:3 min 00 s
Numbers of R-R:163
Symptom :
Av. R-R:0.980s( 61bpm)
Max. R-R:1.030s( 58bpm)
Min. R-R:0.916s( 65bpm)
>>>Unconfirmed report <<< R-R Ratio:112
R-R S.D.:0.027s
R-R C.V.:2.77
Comment:
Analysis result list Print[12/14 2006] P.2/2
03/10 2004 11:11:07 Arrhythmia ID: 000001691952 59years Male Taro Fukuda
Ward1 : HR= 93bpm 842 PVC (Premature Ventricular Contraction) 8-1-2
Ward2 : R-R=0.643s
Medicati: P-R=0.190s
QRS=0.133s
Symptom :
QT =0.309s
QTc=0.385
Comment:
10/16 2003 13:50:50 Arrhythmia ECG[1'00] ID: 000001691952 59years Male Taro Fukuda
Ward1 : HR= 60bpm 846 Frequent PVC 8-1-8 RECORDING LENGTH:1 min 00 s
Ward2 : R-R=1.000s Numbers of R-R:45
Medicati: P-R=0.178s Av. R-R:1.000s( 60bpm)
QRS=0.091s Max. R-R:1.000s( 60bpm)
Symptom :
QT =0.431s Min. R-R:1.000s( 60bpm)
QTc=0.431 R-R S.D.:0.000s
R-R C.V.:0.00
>>>Unconfirmed report <<<
Comment:
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39-4, Hongo, 3-chome, Bunkyo-ku, Tokyo, Japan
Phone:+81-3-3815-2121 Fax:+81-3-3814-1222