Fukuda CardiMax 4 User manual

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

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

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

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

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

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

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

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

i
Preface Introduction
Preface
Introduction
Thank you for purchasing our new electrocardiograph.
This operation manual is intended as a guide to properly operate the CardiMax series FX-8400.
Read this operation manual carefully and make sure that you understand the instructions before using this device.
We recommend that you keep this operation manual handy when operating this product.
If you have any questions or opinions on the product or the manual, contact your local Fukuda Denshi service
representative.
Precaution from Fukuda Denshi
Fukuda Denshi is liable for the safety, reliability, and performance of its device only if;
Maintenance, modifications, and repairs are carried out by authorized personnel.
Components are used in accordance with Fukuda Denshi operating instructions.
When repairing or replacing the parts, contact your nearest service representative.
If the device is used incorrectly and becomes unusable as a result, Fukuda Denshi is not liable for the malfunction.
Use the device only for the purposes specified in this manual.
Contact
If you need more detailed information or information about security risk, please contact following.
(1) Fukuda Denshi Co., Ltd.
3-39-4 Hongo, Bunkyo-ku, Tokyo, Japan
Tel:[phone] Fax:[phone]
E-mail: [email protected]
Website: https://fukuda.com/
(2) Sales Representative
Write the name, address, phone, fax number of your local sales representative.
If a serious incident has occurred in relation to this device, please report it to the manufacturer and to the
competent authority of the country where the user and/or the patient is established.
In case you need the contact information for your national competent authority, please ask the manufacturer or
the distributor from whom you purchased the device.
(Name of Sales Representative, Address, Phone/Fax)

ii
Preface About This Manual
About This Manual
Expression Used in This Manual
Indications for the Screens and Keys
The keys displayed on the screen are indicated by [ ].
(Ex.: [Setting], [To exam], [1/2], etc.)
Other indications on the screen are indicated by " ".
(Ex.: "12-Lead Exam.", "ID", etc.)
The messages displayed on the screen will be indicated by < >.
(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 Solution
1.General Description Features of this Device, Names of Parts and Their Function, How to View the LCD, Basic
Operation Procedure
2.Installation AC Power Connection, Battery Usage, Network Connection, Optional Device Connection
3.Preparation before Examination Electrode Attachment, Checking the Date/Time, Filter/Sensitivity Setup
4.Entering Patient Information Patient Data Categories, Procedure to Enter the Patient Information
5.12-Lead Examination Manual Printing, Auto Printing, Review Printing, Commentary Printing, Extend Printing
6.12-Lead Examination (Advanced
Function) Freeze, Extend Printing, Post-Exercise Examination, ACS Diagnostic Support, Auto Capture
7.Arrhythmia ECG Examination Required Settings, Printing Procedure
8.Rhythm Measurement Rhythm Measurement Recording Procedure
9.File Transfers Initializing the Media, Saving/Reading/Deleting/Correcting the Examination Data,
Communication History
10.DICOM Work List Procedure to Use the DICOM Work List
11. Ordering System Communication Setup, Operation Procedure
12. Printing Daily Report Printing Procedure of Daily Report
13. Settings Displaying the Settings Screen, Saving/Printing the Settings
14. Maintenance and Inspection Periodic Checks, Consumable Parts, Cleaning and Disinfecting, Correcting the Date/Time
15. Appendix Specification, Accessories/Optional Accessories, Check List, Glossary

iii
Preface Reminders to Use the Device Safely
Reminders to Use the Device Safely
Always use the product in accordance with the method of operation and periodic inspection method described in this
manual.
Read this manual thoroughly and understand it before using the device.
Safety Notations
The following safety notations are used throughout this manual. Each of these notations has a different meaning as
shown below.
Read the following information thoroughly to ensure proper, correct and safe use of the product.
An Example of Safety Symbol
Symbols on the Device
The following is a list of symbols used on the FX-8400.
DANGER Indicates a potentially hazardous situation which, if not avoided, will result in death, serious injury, or fire.
WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death, serious injury, or fire.
CAUTION Indicates a potentially hazardous situation which, if not avoided, could result in minor or moderate injury, or
property damage.
Thismark is attached to themain unittoprotect the device from beingdamaged.Themanual provides detailed
information on items to which you have to pay attention.
NOTE A note is not related to product safety, but provides information on proper use to prevent incorrect operation
or malfunction.
Indicates prohibited actions.
Refer to the instruction stated near the symbol.
Indicates a matter of Danger, Warning, or Caution that calls attention for safety.
Refer to the instruction stated near the symbol.
Indicates mandatory or instructed actions.
Refer to the instruction stated near the symbol.
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.
Indicates Type CF applied part with defibrillation-proof.
Indicates the potential equalization terminal.
Indicates the alternating current (AC) power supply.

iv
Preface Reminders to Use the Device Safely
The following symbol is used on the External VGA Adapter
Safety
Design Specifications
This device meets the requirements of IEC 60601-1(2005) +A1(2012), ANSI AAMI / ES 60601-1: A1: 2012+C1:
2009/(R)2012+ A2: 2010/(R)2012 "Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance" and is classified as follows.
1 Protection against electrical shock
Class I Equipment, Internally Powered Device
2 Degree of protection against electrical shock
Type CF Applied Part
3 Degree of protection against ingress of water
No special protection against ingress of water (IPX0).
4 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
5 Operation Mode
Can be used continuously
6 Classification of Sterilization Method
Not intended to be sterilized
7Target
Neonate, Child, Adult
Indicates the LAN port.
Indicates the USB port.
Indicates the SD card slot.
Indicates the serial connector.
Indicates the ECG synchronized signal output connector.
Name and Address of Manufacturer / Date of Manufacture
Indicates the name and address of manufacturer, and date of manufacture.
WEEE (Waste Electrical and Electronics Equipment)
Indicates a separate collection for electrical and electronic equipment.
Indicates the item is a medical device.
Indicates the European authorized representative.
Indicates the manufacturer's serial number.
Indicates the manufacturer's batch code.
Indicates the video output connector.

v
Preface Reminders to Use the Device Safely
Essential Performance
The essential performance of this device is displaying and saving the electrocardiogram.
For necessary information to perform the test for essential performance and basic safety, refer to service personnel.
Preventive Maintenance
The purpose of preventive maintenance is to ensure that the device is in safe operating conditions at all times and
prevent potential future problems.
Perform preventive maintenance at least once every three months.
Inspect the main unit and all connectors and cables for any external damage.
Perform maintenance if one of the following should occur. Do not repair or perform maintenance when the device
is in use.
When the device gets a strong impact due to dropping, etc.
When liquid spills on or into the device
When the device does not function normally
When the enclosure of the device is cracked, broken or damaged
Cables such as the power cable and lead wires have deteriorated in performance
Check all cables, devices and system components for damage, earth impedance, leakage current and accuracy.
Precautions when Using with Other Device
Non-Explosion Proof
Never operate the device where flammable gas or fluid such as anesthetic, oxygen, and hydrogen are used.
Explosion or fire may result.
Never operate the device in the presence of flammable anesthetics, high concentration of oxygen.
This may cause an explosion or fire.
Never use the device in the hyperbaric oxygen therapy chamber.
This may cause an explosion or fire.
Do not ground with a gas pipe. Explosion or fire may result.
MRI
Do not use this device with a magnetic resonance imaging (MRI) device. The device may be pulled towards
the MRI device. Also it may cause failure, damage of this device or burn injury to the patient.
Defibrillator
When using this device with a defibrillator, use only the specified patient cable. The use of a patient cable other
than the specified defibrillation-proof type may damage the device or compromise safety when the device is
used along with a defibrillator.
Do not touch this device or patient during defibrillation. It may cause an electric shock.
While using a defibrillator, ECG cannot be displayed or recorded.
High-frequency Surgical Devices
When using this device with a high frequency external surgical device (electrosurgical instrument), make sure
the contact between the patient and the ground plate is secured. If the connection is incomplete, the patient may
suffer a burn at the electrode site.
When using with electrosurgical instruments, make sure the contact between the patient and the ground plate
canbe sufficiently secured. If the connection isincomplete,the currentfrom the electrosurgical instrument may
run into the electrodes of this device and the patient may suffer a burn at the electrode site. The electrode should
also be attached as far away from the surgery site as possible to decrease the risk of burns.
The amount of noise interference is considerably different depending on the electrode position and surgery site.
Place the ECG electrodes as far away as possible from the surgery site and the ground plate.
DANGER
DANGER
WARNING
WARNING

vi
Preface Reminders to Use the Device Safely
Plug the electrosurgical instrument into a hospital grade outlet as far away as possible from the outlet of this
device. This will reduce interference from the electrosurgical instrument.
While using a high frequency surgical device, ECG cannot be displayed or recorded.
Other Product
Do not connect any unauthorized device.
Connect so that all products satisfy the conditions of operating environment.
Connect only the specified system components in patient environment. (

"Combination Example of Medical
and Non-Medical Equipments" P15-5)
The connecting device outside the patient environment should be provided with the safety level equivalent with
the IEC or ISO standards. Otherwise, it may cause hazardous situation such as electric shock to the patient and
operator. For details of the connecting device, contact your local Fukuda Denshi service representative.
The connecting network equipment outside the patient environment should comply with the EMC standard
(equivalent with CISPR 32 and CISPR 24).
Only the peripheral products and cables specified by Fukuda Denshi should be connected to this device using
the specified procedure. For details of the connection procedure, contact your local Fukuda Denshi service
representative.
When using with other products, the environment conditions (including transport/storage) of the connecting
devices should be also observed. Failure to do so may damage the device. For the environment conditions, refer
to the operation manual of each device.
The operator should not touch the patient and the system composed of this device at the same time. It may cause
hazardous situation such as electric shock to the patient and operator.
When connecting system components to this device, do not use multiple portable socket-outlet or extension
cable.
System Components (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
This device is a type CF applied part, but it is not intended for direct applications to patients'
heart.
Connecting the Power Cable
WARNING
When operating this device using an AC power supply, make sure to connect the power
cable to 115 V AC hospital grade outlet. Use the battery when operating in areas with no
hospital grade outlet. Use an outlet that can provide sufficient power to the device.
Do not use multiple portable socket-outlet, as safety of the patient and operator may not be
WARNING

vii
Preface Reminders to Use the Device Safely
ensured.
Use only the supplied 3-way AC power cable. Use of other cables may result in electric
shock to the patient and the operator.
Leakage Current
CAUTION
If multiple devices are plugged into the same outlet, this may cause greater current leakage
in the devices, causing potential danger to patients.
This danger may occur if the patient has a pacemaker or other heart equipment using
electrical stimulation. Take particular care with safety when recording ECGs in these
conditions. Current leakage needs to be below the allowable limit for safety purposes.
Follow the instructions in the operation manual of the pacemaker or other heart equipment
using electrical stimulation.
When using this device with other devices, perform equipotential grounding to prevent
potential difference between the devices. If potential difference occurs between the devices,
danger may result to the patient and operator.
Do not touch the electrodes of this device or the conductive part of the attached connectors.
Touching these may cause a danger to the patient.
Precautions for Safe Operation of Medical Electrical Equipment
Do not disassemble or modify this device. It may cause a fire hazard or electric shock.
The installation of the battery will be performed by our service representative. Users should not perform this
procedure as it may cause electric shock or burn injury to the operator or malfunction of the device may occur.
Although this device is a transportable device that is designed to be used in different areas, safe operation may
be compromised if it is subjected to strong impact such as being dropped or getting caught in elevator doors
during transportation.
Do not use or store the device in an area where it will be subject to splashing water. Otherwise, it may cause
hazardous situation such as electric shock to the patient and operator.
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.
Do not touch the LAN connector and ECG connector at the same time. It may cause electric shock.
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.
Do not insert the SD card, USB memory in reverse direction or use excessive force when inserting it. It may
damage both the device and the media.
Always hold the plug when removing cables. Do not pull on the cable. Do not insert or remove cables with wet
hands. This may cause electric shocks, short circuiting or injury.
To disconnect this device from commercial power source, unplug the power supply cable from hospital grade
outlet or AC inlet of this device.
WARNING
CAUTION

viii
Preface Reminders to Use the Device Safely
Operate the touch panel display with your finger. Using other items may cause damage such as scratching the
surface of the touch panel.
Do not attach film or adhesive tape to the touch panel. This may result in malfunction or failure.
Wipe the surface with a soft cloth moistened with ethanol.
Do not put your hands close to the feeding area of the recorder while printing is in progress. Your fingers may
get caught or you may be injured.
Make sure to use the specified Li-ion battery pack when operating the device on battery power. Otherwise, acid
leakage, overheating or explosion may occur.
Do not disassemble or remodel the Li-ion battery pack. A protection circuit is incorporated inside the battery
for safety.
When the ECG cannot be properly displayed, "Lead Off" will be displayed.
Inspections
Perform daily checks to maintain safety.
Perform periodic checks once a year to maintain safety.
Check all cables, devices, system components, earth impedance, leakage current, and accuracy.
User should have a thorough knowledge of the operation before using the device.
For installation and storage of the device, pay attention to the following.
Install or store in an area where environmental conditions such as atmospheric pressure, temperature, humidity,
ventilation, sunlight, dust, sodium, and sulfur will not adversely affect the system.
Install the device on a stable surface where there is no inclination, vibration, or shock (including during
transportation).
Place the device with the bottom side downward. Do not place other sides (back or sides) on the floor.
Do not install or store in an area where chemicals are stored or gases are evolved.
Do not subject the device to excessive vibration or impact when moving to a new installation location.
Verify the power frequency, voltage and allowable current (or power consumption).
Ensure the grounding is proper by connecting the accompanying power cable to the hospital grade outlet.
To ensure the safety of medical device, do not place other general electrical equipments within 1.5 meters from
areas where patients are present.
Before operating the device
Verify the power voltage.
Do not use multiple portable socket-outlet, as safety of the patient and operator may not be ensured.
Check the cable connection and polarity to ensure proper operation of the device.
Make sure the power system has adequate earth ground.
Ensure that all cables are connected properly and safely.
During operation of the system
Make sure that the electrodes and patient cable tips do not touch metal areas of the bed or other conductive
items.
Always observe the device and patient to ensure safe operation.
If any abnormality is found on the device or patient, take appropriate measures such as ceasing operation of the
device to ensure safety of the patient.
Do not allow the patient to come in contact with the device.
Do not block the vents. This may result in overheating or a fire hazard.
Do not drop the device or subject it to strong impact or vibration. It may result in electric shock or a fire hazard.
CAUTION
CAUTION
CAUTION
CAUTION

ix
Preface Reminders to Use the Device Safely
If the device is dropped or damaged, contact your local Fukuda Denshi service representative.
Do not pull strongly on the cables such as patient cable.
After using the device
Unplug all the cables from the patient before turning off the power.
When unplugging the cables, do not apply excessive force on the cables.
Keep the accessories and cables together in one place after cleaning.
Keep the device clean to ensure proper operation for the next use.
If the device is damaged, users should not attempt repair. Label the unit "OUT OF ORDER" and contact your
nearest service representative.
Do not remodel the device.
If using a defibrillator while using this device, check the paste volume, output energy, etc. to prevent the risk
of burn injury of the patient. Also, verify that each device is properly grounded.
SD card, USB memory
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 doesnot coverdata retrieval or repair that is required when problems
such as these are caused by using unspecified items. When the specified media is inserted, corresponding icon
will be displayed on the status display area.
Do not remove media while data is being saved to the media. The data may become unreadable. This may
include the data that was already saved in addition to the data that was being saved at the time. If connecting
an extension cable to the USB port, use an extension cable not longer than 2 m. The device may not operate
properly if a cable longer than 2 m is used.
Other precautions specific to each medium can be found on the corresponding pages. Make sure to also read these
precautions.
Precautions for Battery Pack
Do not throw into fire, heat, disassemble or modify.
Do not drop or apply strong impact.
Do not use on unspecified device.
Do not short-circuit the terminals.
The battery must be charged on specified device.
Recycling
To effectively use these limited resources, your cooperation in recycling the battery will be appreciated.
For recycling procedure, refer to Fukuda Denshi service representative, or follow the disposal processing
procedure.
Precautions Concerning the LAN
Network Equipment
Network equipment including PC and hub should be located "outside patient environment (IEC 60601-1(2005)
+A1(2012), ANSI AAMI / ES 60601-1: A1: 2012+C1: 2009/(R)2012+ A2: 2010/(R)2012)". If located in
patient environment, it may cause hazardous situation such as electric shock to the patient and operator.
CAUTION
CAUTION
DANGER
CAUTION
WARNING

x
Preface Reminders to Use the Device Safely
Inspections
Use only Ethernet hubs specified by Fukuda Denshi when connecting this device to the network (LAN).
When connecting this device to the network (LAN), the LAN cable should be not longer than 50 m.
Precautions Concerning Use of the USB Wireless LAN Adapter
When using a wireless LAN, follow the management policy of each medical institution.
Turn OFF the power of this device before inserting the wireless LAN adapter. Never remove the wireless LAN
adapter during wireless LAN communication. An error may occur if the wireless LAN adapter is inserted or
removed during operation.
Do not use this device in areas with static electricity or electromagnetic interference, in rooms insulated with
a metal door or near devices that emit radio waves (microwaves, thermotherapy devices, etc.)
The device may not be able to receive radio waves in some operating environments.
Due to the characteristics of radio waves, the communication range and communication speed vary depending
on the installation location and operating environment.
Precautions when Using with Wireless LAN Adapter
When using a wireless LAN, make sure to check the operation of any medical devices nearby. Stop using the
wireless LAN immediately if unexpected waveform noise occurs or there is interference from surrounding
device.
Precautions Concerning the Wireless LAN Adapter
Use a wireless LAN adapter specified by Fukuda Denshi.
If an unspecified wireless LAN is used, not only that the communication failure with the DMS may occur, but
the damage of the main unit may also occur. The warranty does not cover data retrieval or repair that is required
when problems such as these are caused by using unspecified items.
Precautions about the Static Electricity
The wireless LAN adapter is extremely delicate and is very vulnerable to damage from electrostatic discharge.
If the human body comes in contact with the metal part of the wireless LAN adapter, static electricity may be
discharged onto the parts or into the circuit of the wireless LAN adapter, whichmay damage the wireless LAN
adapter. Make sure to follow the precautions below to protect the wireless LAN adapter and this device from
damage caused by static electricity.
Remove static electricity from the body before using.
Hold the end of the wireless LAN adapter when handling it. Never touch the metal part of the wireless LAN
adapter.
Storage, Transportation, and Disposal
Storage and Cleaning
Do not open the housing.
To clean the housing, use a soft cotton cloth, or non-woven cloth (pulp, rayon, polyethylene, etc.).
Clean the device frequently so stains can be removed easily.
To prevent injury, it is recommended to wear gloves when cleaning the device.
Pay attention not to allow chemical solution to enter the device or connectors.
Do not use organic solvents, thinner, toluene or benzine to avoid damaging the resin case.
Do not polish the device with abrasive, chemical cleaner, alkaline or acidic detergent.
Perform daily checks to maintain safety.
Perform regular inspections every 12 months to maintain safety.
Check all cables, devices, accessories, earth impedance, leakage current, and accuracy.
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION