Fukuda Denshi CARDIMAX FX-7202 User manual

• Before using this device, read this operation manual.
• Store this manual in a location near the unit for future reference.
OPERATION MANUAL
CARDIMAX
FX-7202
ELECTROCARDIOGRAPH
0086
Ver.04

0086
This device bears a CE label in accordance with the provisions of Medical Device
Directive 93/42/EEC.
PERSONS RESPONSIBLE FOR SUPPLYING DEVICES TO 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.
Copyright 2008 Fukuda Denshi Co., Ltd.
No part of this document may be copied or transmitted in any form without the prior
written permission of Fukuda Denshi Co., Ltd.
Printed in Japan
Note:
Only qualified physicians or persons under instructions from physicians are
allowed to use the FX-7202.
This Operation Manual is for FX-7202 Version 04.

i
How to Use the Operation Manual
Congratulations on the purchase of your new electrocardiograph from Fukuda Denshi!
This operation manual is intended as a guide for proper operation of the Cardimax
FX-7202.
Be sure to read and understand this manual thoroughly before using the Cardimax
FX-7202 so you can perform each task smoothly and fully utilize the functions offered
by this device.
If you have any questions or views about our product or manual, contact your local
Fukuda Denshi sales and service representative.
This manual is organized into 8 chapters, with 4 appendices, glossary, and index.
Chapter 1, "General Information" deals with a general introduction to the Cardimax
FX-7202. This chapter contains illustrations of the Cardimax FX-7202 so you can
become familiar with the equipment before beginning use.
Chapter 2, "Preparing the Cardimax FX-7202" provides you with a step-by-step
procedure to set up the Cardimax FX-7202. This chapter also contains the procedure
for charging the rechargeable battery.
Chapter 3, "Operating the Cardimax FX-7202: Recording a Standard 12-lead ECG in
the Automatic Recording Mode" describes step-by-step the entire operation flow
starting from connecting the patient cable to the electrode and attaching the electrodes
to the patient, to recording the electrocardiogram using—as an example—the
Automatic Recording of the standard 12-lead ECG. This chapter also provides
information about the screen and keys on the touch-panel and operation panel.
Chapter 4, "Recording the Electrocardiogram: Standard ECG Mode" contains
information on how to record the electrocardiogram using the standard ECG mode.
Chapter 5, "Recording the Electrocardiogram: Advanced Features" contains information
on how to record the electrocardiogram using advanced features, including the Review
Recording, R-R Trend Test Mode, Arrhythmia ECG Mode, and Arrhythmia Automatic
Extension Recording Modes. (The Arrhythmia ECG Mode and Arrhythmia Automatic
Extension Recording Mode are available only when the PC-7403 program cartridge is
installed.)
Chapter 6, “Managing ECG Data Files” contains information on how to read ECG data
from the built-in memory.
Chapter 7, "Setting Up the Parameters of the Cardimax FX-7202" contains information
on how to set up parameters such as the number of display channels and recording
format using the SET UP MODE screens in accordance with your purposes.
Chapter 8, "Maintenance and Troubleshooting" deals with basic maintenance
procedures. It also provides information on what to do when you are unable to
measure an accurate electrocardiogram, and includes a list of error messages and their
recovery actions.
Appendix A, "Specifications" gives you the main specifications for the Cardimax
FX-7202.
Appendix B, "Daily Check Lists" summarizes the daily check items and their
procedures.
Appendix C, "Periodic Check Lists" summarizes the periodic check items and their
procedures.

ii
Appendix D, "LAN communication function" explains the LAN connection method and
the SCP-ECG Data Structures.
The Glossary explains the technical terms used in this manual.
The Index is provided to locate specific information quickly.
Conventions ______________________________________________________
Keys
The step-by-step operation procedures in this manual are shown with screens and text.
When you operate the Cardimax FX-7202, you use the Operation Panel keys and
function keys of the Touch-panel. In this manual, the keys are indicated in the
following manner.
Example of an Operation Panel key: [START/STOP]
Press the relevant key on the Operation Panel.
Example of a function key on the Touch-panel: [MANUAL]
Touch the relevant function key on the Touch-panel.
Optional features
This manual provides information on the operation of the Cardimax FX-7202 and the
additional functions it can provide when you plug in the PC-7403 program cartridge.
Some of the functions are available only when the program cartridge is installed. The
operation of the FX-7202 varies depending on the installed program cartridge. In this
manual, the functions inherent to the PC-7403 program cartridge are identified with the
following icon to set them apart:
Indicates the function available only when you have installed the PC-7403
program cartridge in the Cardimax FX-7202.

iii
Special Notice to User
Malfunction caused by EMC
The Cardimax FX-7202 complies with the safety standards IEC60601-2-25 (1999) and
IEC60601-1-2 (2001). However, if there is a strong electromagnetic wave nearby that
exceeds the prescribed limit, the device could malfunction. If this happens, provide
the required countermeasures.
Influence of radiation electromagnetic wave:
The use of a cellular phone could affect the operation of the FX-7202. Alert persons in
a facility where medical electronic equipment is installed to turn off their cellular phones
and small radio equipment.
Influence of bursts and conduction electromagnetic wave:
High-frequency noise from other equipment may infiltrate into the FX-7202 through the
AC outlet. Identify the noise source and stop use of the relevant equipment if possible.
If this equipment cannot be shut down, provide the countermeasures for this noise
route using a noise suppressing device, etc.
Influence of static electricity:
The discharge of static electricity could affect the operation of the FX-7202 in a dry
environment (room), particularly in winter. Before using the FX-7202, humidify the
room or discharge static electricity from a patient and person who will record the ECG.
Influence of surge (lightening):
If there is a thunderstorm occurring nearby, it might cause a voltage surge in the FX-
7202. If you expect any danger, unplug the power supply cord from the AC outlet and
run the FX-7202 on built-in battery power (optional). Also use an uninterruptible power
supply, if you have one.

iv
Equipment classification
The Cardimax FX-7202 falls under the following equipment classifications:
1) Protection against electrical shock
Class I, Internally powered
2) Type against electrical shock
Applied part: Type CF
3) Protection against liquids entering the device
General equipment standards
4) Operating safety in the presence of air-inflammable anesthetic gases or
oxygen/nitrous oxide-anesthetic gases
The equipment must be used in an environment free from inflammable anesthetic
gases or inflammable cleaning agents.
5) Running mode
Continuous running mode

v
Safety Precautions
•Before using the Cardimax FX-7202, be sure to read this section to ensure safety and
correct operation.
•Be sure to follow the precautions given below. These are important matters related to
safety.
Safety notifications
The following three safety notices alert the user to the level of hazard and damage that
may result from not following the instructions or from misuse of the equipment.
DANGER Ignoring these instructions could cause death, serious
injury, or major fire.
WARNING
Ignoring these instructions could cause death, serious
injury, or fire.
CAUTION
Ignoring these instructions could cause injury or damage
to the equipment.
Safety icons
The following icons appear with the instructions given in safety notices. They basically
categorize what you should do or not do in the following manner:
Indicates actions that are prohibited.
Provides instructions for dangers, warnings, and cautions.
Indicates actions that must be performed.

vi
DANGER
CAUTION
CAUTION
Precautions on analysis program
Interpretation and Minnesota codes given by the Cardimax FX-7202 do not instruct
the physician as to the kind and degree of cardiac disease. Accordingly, four value
judgments are given for electrocardiogram (ECG) waveform and although "abnormal"
indicates a large possibility of organic cardiac disease, there are cases where no
cardiac disease exists despite an abnormal ECG (that is, an abnormal ECG may be
caused by something other than the heart). On the other hand, care should be
taken in the event any preclinical coronary arteriosclerosis could be present despite a
normal ECG interpretation. Therefore, for a proper diagnosis, the ECG should be
integrated with other interpretations. This program is not an arrhythmia monitor.
The FX-7202 has no arrhythmia alarms.
Precautions on measurement program
The equipment may measure the ECG waveform incorrectly due to external noise
(such as a drift of baseline, electromyogram, AC interference, etc.). Another matter
which requires careful consideration is that tiny R waves in V1 and V2 may be
overlooked and the S wave could be interpreted as Q wave.
Precautions on battery pack
•Be sure to use the specified battery pack (T8HRAAU-4713).
•Be sure to charge the battery using the Cardimax FX-7202.
Charging the battery using other equipment could lead to a
hazard.
•Do not disassemble or mutilate the battery. You could burn
yourself.
•Do not incinerate or heat the battery. You could burn yourself,
or the battery could burst or leak toxic substances.
•Do not short the battery. You could burn yourself.
•Keep away from children.
•If the liquid contained in the battery gets into your eyes, do not
rub them. Wash your eyes thoroughly with water and see a
doctor immediately.

vii
WARNING
WARNING
WARNING
DANGER
Nonexplosion proof
Do not operate the FX-7202 in an environment where there is a
risk of explosion. Do not operate the FX-7202 in the presence of
flammable anesthetics.
Magnetic resonance imaging
Do not operate the FX-7202 during Magnetic Resonance Imaging
(MRI) scanning. The conducting current may cause burns.
Operating the FX-7202 may affect the MRI image, while the MRI
may affect the accuracy of the FX-7202.
High-frequency surgery
The patient cable (CP-104T,CP-104L or CP-104J) contains
resistors installed in the lead wire plugs to prevent damage to the
equipment when used in the presence of high frequency surgery
apparatus. These components reduce the risk of not only device
damage, but also the risk of burns to the patient.
Defibrillation protection
The FX-7202 may remain connected to the patient during
defibrillation only if the proper patient cable provided with
defibrillator protection is being used. The patient cable (CP-
104T,CP-104L or CP-104J) is provided with defibrillation
protection. The FX-7202 will not be damaged when these
cables are used, even if the defibrillator paddles come into
contact with the ECG electrodes.

viii
DANGER
Connection
•This isolation measure is provided to protect the patient.
Operation is bypassed if the electrodes on the patient cable
come into contact with any other metal object or other
electrically conductive objects, including the operator’s hands.
When such contacts occur, there is a risk of electric shock,
regardless of whether or not the objects are grounded.
•All ECG wires (patient connections), connectors, and amplifiers
are electronically isolated from the rest of the device and from
ground. This isolation restricts the current that can pass
through a patient to less than 10 microamperes.
•If the power supply cords of several different units are
connected together in a multiple outlet tap, an increase in
chassis leakage current can create a potential hazard.
•When a cardiac pacemaker or other electrical stimulator is
connected to the patient, it increases the risk of a potential
hazard. Pay particular attention to safety measures to record
ECG in such conditions. Appropriate measures must be taken
to assure that the chassis leakage current is at a safe level.
•The FX-7202 is Type CF equipment. It must not, however, be
placed in direct contact with the area of the heart.
Be sure to connect the power supply cord to a hospital-grade wall
AC outlet. If no hospital-grade wall outlet is available, connect
the potential equalization cable securely to a proper ground. If
no proper grounding is available, operate the FX-7202 on its
rechargeable battery.

ix
CAUTION
CAUTION
WARNING
WARNING
Preventive maintenance
The purpose of preventive maintenance is to assure that the
device is always in a safe operating condition and to prevent
possible future problems. Preventive maintenance should be
performed at least once during each 12-month period.
Preventive maintenance consists of a thorough inspection of the
device, all connections, and all attached cables for signs of
physical damage. Immediate maintenance must be performed if:
•The device was subject to extreme mechanical stress; e.g.,
after a heavy fall.
•Liquid or fluids have spilled on or into the device.
•The device does not function, or functions improperly.
•Parts of the device cabinet are cracked, broken, or damaged.
•The power supply cord or the patient cable and interconnecting
cables show signs of deterioration.
Transportation
When transporting the FX-7202, pack it with the specified packing
materials.
Disposing of the FX-7202, accessories, and options
When you dispose of the FX-7202, accessories, or optional parts,
entrust them to specialized industrial waste dealers.
Paper loading
When the recording paper will be loaded, be careful about edge.
Failure to do so may cause injury.

x
CAUTION
General precautions
•Do not use or store the FX-7202 in a place where it may be
exposed to a liquid spill.
Liquid in the equipment can be a source of danger such as
electric shocks to a patient or operator of the FX-7202.
•Do not subject the FX-7202 to a strong impact or vibration
and do not drop it.
Such damage to the equipment could cause an electric shock
or fire. If you unintentionally drop the FX-7202, contact your
local Fukuda Denshi sales and service representative.
•Do not subject the liquid crystal display to a strong impact.
The device can be damaged by unwarranted force.
•Make sure that a patient does not come in contact with the
FX-7202, other electric appliances, or metal.
Such contact increases the leakage current and can become a
source of danger to a patient.
•When you unplug a cord, be sure to hold the plug to
remove the cord (do not pull the cord itself). Also, do not
plug/unplug the cord with wet hands.
This could cause an electric shock, short circuit, or injury.
•Operate the touch-panel display with a finger.
If you tap the touch-panel screen with a tool instead of your
finger, this could damage the surface of the touch-panel screen
and cause the device to malfunction.
•Wipe off dirt on the surface of the touch-panel display with a
soft cloth moistened using ethanol or with the silicon cloth
supplied with the accessories.
Checks：
•Perform the daily checks to assure the safety of the FX-7202.
•Perform the periodical checks every three to four months to
assure the safety of the FX-7202.
Perform the periodical checks to be performed by a specialist
every 12 months to assure the safety of the FX-7202.

xi
Equipment Symbols ________________________________________________
The following symbols are printed on the Cardimax FX-7202.
Attention: Read the Operation Manual.
Type CF equipment
Potential equalization terminal
AC power supply
LAN port

xii
Guidance for Electromagnetic Compatibility (EMC) ________________________
Details about the electromagnetic compatibility (EMC) of the Cardimax FX-7202 are
given below. Before using the FX-7202, be sure to read and understand the following
information.
Compliance with electromagnetic emissions
The Cardimax FX-7202 is intended for use in the electromagnetic environment
specified in the following table. Before using the FX-7202, check the environment of
the site where it is used.
Emissions test Compliance Electromagnetic environment/guidance
RF emissions
CISPR 11
Group 1 The Cardimax FX-7202 uses RF energy
for its internal functions only.
Therefore, its RF emissions are very low
and are not likely to cause any
interference in electronic equipment
installed nearby.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC61000-3-2
Class A
Voltage
fluctuations/flicker
emissions
IEC61000-3-3
Compliance
The Cardimax FX-7202 is suitable for
use in all types of buildings, including
private houses. It can be used by
direct connection to the commercial low-
voltage power supply in buildings used
for domestic purposes.

xiii
Compliance with electromagnetic immunity 1
The Cardimax FX-7202 is intended for use in the electromagnetic environment
specified in the following table. Before using the FX-7202, check the environment of
the site where it is used.
Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic
environment/guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±6kV: Contact
±8kV: Air
±6kV: Contact
±8kV: Air
The desirable floor materials
are wood, concrete, or ceramic
tiles. If the floors are covered
with synthetic material, the
relative humidity should be at
least 30%.
Electrical fast
transition/burst
IEC 61000-4-4
±2kV: Power
supply lines
±1kV:
Input/output
lines
±2kV: Power
supply lines
±1kV:
Input/output
lines
The power supply quality
should be that of a standard
commercial or hospital
environment.
Surge
IEC 61000-4-5
±1kV:
Differential
mode
±2kV: Common
mode
±1kV:
Differential
mode
±2kV: Common
mode
The power supply quality
should be that of a standard
commercial or hospital
environment.
Voltage drops,
dips, and
fluctuations of
input power
supply line
IEC 61000-4-
11
<5% UT(>95%
drop in Uт) for
0.5 cycle
<40% UT
(>60% drop in
Uт) for 5 cycles
<70% UT
(>30% drop in
Uт) for 25
cycles
<5% UT(>95%
drop in UT) for
5 seconds
<5% UT(>95%
drop in Uт) for
0.5 cycle
<40% UT
(>60% drop in
Uт) for 5 cycles
<70% UT
(>30% drop in
Uт) for 25
cycles
<5% UT(>95%
drop in UT) for
5 seconds
The power supply quality
should be that of a standard
commercial or hospital
environment. If the FX-7202
user requires continuous
operation even during a power
failure, it is recommended to
use an uninterruptible power
supply or a battery (optional).
Magnetic field
of commercial
frequency
(50/60Hz)
IEC 61000-4-8
3 A/m 3 A/m The power frequency magnetic
field should have the same
characteristics as that of
general locations in a standard
commercial or hospital
environment.
Note:
UTputs priority on the AC power supply voltage over the applied test level.

xiv
Compliance with electromagnetic immunity 2
The Cardimax FX-7202 is intended for use in the electromagnetic environment
specified in the following table. Before using the FX-7202, check the environment of
the site where it is used.
Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic
environment/guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150kHz to
80MHz
3 Vrms
Radiated RF
IEC 61000-4-3
3 V/m
80kHz to
2.5GHz
3 V/m
Portable and mobile RF
communications equipment
must not be operated closer to
any part of the FX-7202
(including cables) than the
recommended separation
distance calculated from the
formula applicable to the
transmitter frequency.
Recommended separation
distance:
d=1.2 P
d=1.2 P80MHz to 800MHz
d=2.3 P800MHz to 2.5GHz
Where Pis the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer, and dis the
recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters (determined by an
electromagnetic site survey*)
must be lower than the
compliance level in each
frequency range**.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
Notes:
•The higher frequency range is between 80MHz and 800MHz.
•These guidelines may not apply in all situations. Electromagnetic propagation is
affected by reflection and absorption from buildings, objects, and people.
*: The field strengths of fixed transmitters, such as base stations for radio
(cellular/cordless) phones and land mobile radios, amateur radio, AM/FM radio
broadcast and TV broadcast base stations cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment produced by fixed RF
transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the site where the FX-7202 is used exceeds the
applicable RF compliance level above, the equipment should be monitored to
assure normal operation. If an abnormality is observed, additional measures may
be necessary, such as re-orienting or relocating the FX-7202.
**: Over the frequency range 150kHz to 80MHz, field strengths should be less than
3 V/m.

xv
Recommended separation distance between portable/mobile RF communications
equipment and the FX-7202
The Cardimax FX-7202 is intended for use in an electromagnetic environment where
RF emission interference is controlled. The electromagnetic interference can be
prevented during operation by providing a minimum distance between portable/mobile
RF communications equipment (transmitters) and the FX-7202 as recommended below
(according to the maximum output power of the transmitter).
Separation distance according to frequency of transmitter (m)
Rated maximum
output power of
transmitter (W) 26MHz to 80MHz
d=1.2 P
80MHz to 800MHz
d=1.2 P
800MHz to 2.5GHz
d=2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance din meters (m) can be estimated using the formula applicable to
the frequency of the transmitter. Pin the formula is the maximum output power rating
of the transmitter in watts (W) according to the transmitter manufacturer.
Notes:
•The separation distance is applied for the higher frequency range of 80MHz to
800MHz.
•These guidelines may not apply in all situations. Electromagnetic propagation is
affected by reflection and absorption from buildings, objects, and people.

xvi

xvii
Contents
How to Use the Operation Manual ......................................................................... i
Special Notice to User .................................................................................................................. iii
Safety Precautions......................................................................................................................... v
Chapter 1. General Information .......................................................................... 1
Introduction ....................................................................................................................................1
Names and Functions of Parts.......................................................................................................4
Accessories....................................................................................................................................8
Optional Parts and Consumables ................................................................................................11
Chapter 2. Preparing the Cardimax FX-7202 ................................................... 13
Loading the Recording Paper ......................................................................................................14
Connecting the Power Supply Cord.............................................................................................17
Connecting the Ground................................................................................................................18
Connecting the Patient Cable ......................................................................................................19
Turning ON Power .......................................................................................................................20
Adjusting the Display Contrast.....................................................................................................22
Setting the Date Format and Built-in Clock..................................................................................23
Setting the Hospital Name ...........................................................................................................26
Setting the Language...................................................................................................................28
Using the Battery (Option) ...........................................................................................................30
Installing the Program Cartridge (Option) ....................................................................................33
Connecting the Cardimax FX-7202 to Optional Equipment.........................................................35
Chapter 3. Operating the Cardimax FX-7202:Recording a Standard 12-lead
ECG in the Automatic Recording Mode.......................................... 36
Connecting the Patient Cable to the Electrodes..........................................................................36
Attaching the Electrodes to the Patient........................................................................................37
Operation Panel ...........................................................................................................................39
Touch-Panel Display....................................................................................................................41
Main Menus..................................................................................................................................44
Entering Patient Data...................................................................................................................45
Recording the ECG ....................................................................................................................53
Chapter 4. Recording the Electrocardiogram: Standard ECG Mode ................ 56
Automatic Recording Mode..........................................................................................................58
Manual Recording Mode..............................................................................................................62

xviii
Chapter 5. Recording the Electrocardiogram: Advanced Features .................. 66
Review Recording........................................................................................................................67
R-R Trend Test Mode ..................................................................................................................69
Arrhythmia ECG Mode .................................................................................................73
Arrhythmia Automatic Extension Recording.................................................................77
Compressed Recording ...............................................................................................................79
Chapter 6. Managing ECG Data Files .............................................................. 82
Reading ECG Data from the Built-in Memory..............................................................................83
Deleting ECG Data ......................................................................................................................89
Chapter 7. Setting Up Parameters of the Cardimax FX-7202 .......................... 90
Overview of Parameters ..............................................................................................................90
General Flow of the Parameter Setup Procedure........................................................................98
Selecting the Number of Waveform Display Channels..............................................................102
Selecting the Recording Format ................................................................................................103
Changing the Patient Data Parameters .....................................................................................118
Selecting the Filters ...................................................................................................................120
Initializing Parameters................................................................................................................121
Chapter 8. Maintenance and Troubleshooting................................................ 123
Performing the Self-diagnostics Test.........................................................................................123
Cardimax FX-7202 Maintenance ...............................................................................................130
When You cannot Record an Accurate ECG.............................................................................132
When an Error Message is Displayed .......................................................................................133
Appendix A. Specifications................................................................................ 136
Appendix B. Daily Check List ............................................................................ 139
Appendix C. Periodic Check List ....................................................................... 140
Appendix D. LAN communication function ........................................................ 142
1. Setting the Network Connection ..................................................................... 142
Initial Network Setup ................................................................................................................143
2. Managing ECG Data Files.............................................................................. 155
Reading ECG Data from the Built-in Memory............................................................................156
Transmitting ECG Data to a PC.................................................................................................161