Fukuda Denshi FX-7102 User manual

• Before using this device, read this operation manual.
• Store this manual in a safe location near the unit for future reference.
OPERATION MANUAL
CARDIMAX
FX-7102
ELECTROCARDIOGRAPH
0197

This device bears a CE label in accordance with the provisions of Medical Device
Directive 93/42/EEC.
THE PERSONS RESPONSIBLE FOR PLACING DEVICES ON THE EC MARKET
UNDER MDD 93/42/EEC.
NAME: FUKUDA DENSHI UK
ADDRESS: 13 WESTMINSTER COURT, HIPLEY STREET OLD WOKING,
SURREY GU22 9LG, U.K.
Copyright 2004 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 China
0197
Note:
Only qualified physicians or persons under instructions from physicians are
allowed to use the FX-7102.

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-
7102.
Be sure to read and understand this manual thoroughly before using the Cardimax FX-
7102 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 7 chapters, with 4 appendices, glossary, and index.
Chapter 1, "General Information" deals with a general introduction to the Cardimax FX-
7102. This chapter contains illustrations of the Cardimax FX-7102 so you can become
familiar with the equipment before beginning to use.
Chapter 2, "Preparing the Cardimax FX-7102" provides you with a step-by-step
procedure to set up the Cardimax FX-7102. This chapter also contains the procedure
for charging the rechargeable battery.
Chapter 3, "Operating the Cardimax FX-7102: 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 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, “Managing ECG Data Files” contains information on how to read ECG data
from the built-in memory.
Chapter 6, "Setting Up the Parameters of the Cardimax FX-7102" 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 7, "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-
7102.
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.
Appendix D, "ECG DATA FORMAT" summarizes the SCP-ECG (Standard
Communications Protocol for Computer-Assisted Electrocardiography) data format of
ANSI/AAMI EC71.

ii
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-7102, you use the Operation Panel keys. 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.
ex.
Press 【START/STOP】on the Operation Panel.

iii
Special Notice to User
Malfunction caused by EMC
The Cardimax FX-7102 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-7102. 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-7102 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-7102 in a dry
environment (room), particularly in winter. Before using the FX-7102, 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-
7102. If you expect any danger, unplug the power supply cord from the AC outlet and
run the FX-7102 on built-in battery power (optional). Also use an uninterruptible power
supply, if you have one.

iv
Equipment classification
The Cardimax FX-7102 falls under the following equipment classifications:
1) Protection against electrical shock
Class II, 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-7102, 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.
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:
DANGER
WARNING
CAUTION
Ignoring these instructions could cause death, serious
injury, or major fire.
Ignoring these instructions could cause death, serious
injury, or fire.
Ignoring these instructions could cause injury or damage
to the equipment.
Indicates actions that are prohibited.
Provides instructions for dangers, warnings, and cautions.
Indicates actions that must be performed.

vi
CAUTION
DANGER
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 AC adapter
• Be sure to use specified AC adaptor (OA-467).
• Be sure to secure power supply voltage specified by the
operation manual. Otherwise, fire, ignition, heating, electric
shock, or burn may result.
• Be sure to insert the power plug into the receptacle securely.
Do not use the equipment with the power plug inserted halfway.
• Do not use the equipment in an atmosphere of flammable gas.
Otherwise explosion or fire may result due to ignition.
• Do not touch the live AC adaptor. Otherwise low-temperature
burn may result.
• Do not wet the equipment with water, rain water, or sea water.
Do not use the equipment in wet state or operate it with wet
hands. Do not use the equipment in a high humidity
environment such as bathroom. Otherwise, fire, ignition,
heating, electric shock or injury may result.
• Do not repair, deform, modify, or disassemble the equipment.
Otherwise insufficient insulation may result or the safety device
may be damaged, thus causing fire, ignition, heating, electric
shock, or injury.
• Do not wrap the AC adaptor cord or power cable around the AC
adaptor. Otherwise break or failure may result.
• Do not place a heavy object on the equipment or use it in the
state covered with cloth or quilt. Otherwise heat may
accumulate, thus causing deformation of the case or fire.
• If the equipment is not used for a long period of time, pull the
power cord out of the receptacle. Otherwise ignition or heating
may result.
• Be sure to pull the power plug out of the receptacle before
performing maintenance to ensure safety.

vii
DANGER
WARNING
WARNING
DANGER
Precautions on battery pack
• Be sure to use the specified battery pack (8PH-4/3A3700-H-
J18).
• Be sure to charge the battery using the Cardimax FX-7102.
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.
Nonexplosion proof
Do not operate the FX-7102 in an environment where there is a
risk of explosion. Do not operate the FX-7102 in the presence of
flammable anesthetics.
Magnetic resonance imaging
Do not operate the FX-7102 during Magnetic Resonance Imaging
(MRI) scanning. The conducting current may cause burns.
Operating the FX-7102 may affect the MRI image, while the MRI
may affect the accuracy of the FX-7102.
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.

viii
WARNING
DANGER
Defibrillation protection
The FX-7102 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-7102 will not be damaged when these
cables are used, even if the defibrillator paddles come into
contact with the ECG electrodes.
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-7102 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-
7102 on its rechargeable battery.
• In case hum noise is apparent on ECG waveform depending on
the operating environment, connect the equipment to the
ground using potential equalization cable CE-12.

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-7102, pack it with the specified packing
materials.
Disposing of the FX-7102, accessories, and options
When you dispose of the FX-7102, 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-7102 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-7102.
• Do not subject the FX-7102 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-7102, 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-7102, 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.
• Wipe off dirt on the surface of the liquid crystal 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-7102.
• Perform the periodical checks every three to four months to
assure the safety of the FX-7102.
Perform the periodical checks to be performed by a specialist
every 12 months to assure the safety of the FX-7102.

xi
Equipment Symbols ________________________________________________
The following symbols are printed on the Cardimax FX-7102.
Attention: Read the Operation Manual.
Type CF equipment
Potential equalization terminal
AC power supply
LAN port
CONTRAST
CONTRAST volume

xii
Guidance for Electromagnetic Compatibility (EMC) ________________________
Details about the electromagnetic compatibility (EMC) of the Cardimax FX-7102 are
given below. Before using the FX-7102, be sure to read and understand the following
information.
Compliance with electromagnetic emissions
The Cardimax FX-7102 is intended for use in the electromagnetic environment
specified in the following table. Before using the FX-7102, 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-7102 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-7102 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-7102 is intended for use in the electromagnetic environment
specified in the following table. Before using the FX-7102, 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-7102
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-7102 is intended for use in the electromagnetic environment
specified in the following table. Before using the FX-7102, 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-7102
(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 P
80MHz to 800MHz
d=2.3 P
800MHz 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-7102 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-7102.

xv
**: Over the frequency range 150kHz to 80MHz, field strengths should be less than
3 V/m.
Recommended separation distance between portable/mobile RF communications
equipment and the FX-7102
The Cardimax FX-7102 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-7102 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
Accuracy of evaluated data __________________________________________
This instrument conforms to safety requirements and achieves basic performance
stipulated by safety standards IEC60601-2-25 (1999) and IEC60601-2-51 (2003). The
following performance is assured for the tests required in those standards.
Automatic ECG measurement
1. How to determine the amplitude of P wave, QRS wave, ST, and T wave
Amplitude of P1A and P2A: The first waveform is defined as P1A and the second as
P2A, with biphasic property taken into consideration. The
value from the base point (start point of P wave) to the peak
is defined as the amplitude of each waveform.
Amplitude of QRS wave: The first upward swing is defined as R wave, the downward
swing that appears before R wave as Q wave, and the
downward swing that appears after R wave as S wave.The
value from the base point (start point of QRS wave) to the
peak is defined as the amplitude of each waveform.
Amplitude of ST: The amplitude at the end of the QRS wave with the QB-TE
line defined as the baseline
Amplitude of T1A and T2A: The first waveform is defined as T1A and the second as
T2A, with biphasic property taken into consideration. The
value from the QB-TE baseline to the peak is defined as the
amplitude of each waveform.
QT time
A: Amplitude(Amp)
QRS
PR
P1A
P2A S'A
R'A T1A
T2A
QA SA
RA
UA
2. Handling of isoelectric part
Measurement of the isoelectric part is not performed.
3. Minimum allowable wave and stability of measurement
The minimum amplitude value recognizable as a waveform is 20mV.

xvii
Contents
How to Use the Operation Manual........................................................................... i
Special Notice to User .................................................................................................................. iii
Safety Precautions......................................................................................................................... v
Contents......................................................................................................................................xvii
Chapter 1 General Information........................................................................... 1
Introduction ....................................................................................................................................1
Names and Functions of Parts.......................................................................................................3
Operation Panel .............................................................................................................................7
Accessories....................................................................................................................................9
Optional Parts and Consumables ................................................................................................11
Chapter 2 Preparing the Cardimax FX-7102.................................................... 13
Loading the Recording Paper ......................................................................................................14
Connecting the Power Supply Cord.............................................................................................22
Connecting the Patient Cable ......................................................................................................24
Turning ON Power .......................................................................................................................25
Adjusting the Display Contrast.....................................................................................................27
Setting the Date Format and Built-in Clock..................................................................................28
Setting the Language...................................................................................................................31
Using the Battery (Option) ...........................................................................................................33
Connecting the Cardimax FX-7102 to Optional Equipment.........................................................36
Chapter 3 Operating the Cardimax FX-7102: Recording a Standard 12-lead
ECG in the Automatic Recording Mode.......................................... 37
Connecting the Patient Cable to the Electrodes..........................................................................37
Attaching Electrodes to the Patient..............................................................................................38
Liquid Crystal Display(LCD).........................................................................................................40
Main Menus..................................................................................................................................42
Entering Patient Data...................................................................................................................43
Recording the ECG......................................................................................................................46
Chapter 4 Recording the Electrocardiogram: Standard ECG Mode................. 48
Chapter 5 Managing ECG Data Files ................................................................ 57
Reading ECG Data from the Built-in Memory..............................................................................58
Transmitting ECG Data to External Device ................................................................................61
Reviewing ECG data....................................................................................................................63
Chapter 6 Setting Up Parameters of the Cardimax FX-7102 ........................... 66
Overview of Parameters ..............................................................................................................66
General Flow of the Parameter Setup Procedure........................................................................72
Selecting the Number of Waveform Display Channels................................................................75
Selecting the Recording Format ..................................................................................................76
Changing the Patient Data Parameters .......................................................................................88
Selecting the Filters .....................................................................................................................89
Initializing Parameters..................................................................................................................90

xviii
Chapter 7 Maintenance and Troubleshooting .................................................. 92
Performing the Self-diagnostics Test...........................................................................................92
Cardimax FX-7102 Maintenance ...............................................................................................100
When You cannot Record an Accurate ECG.............................................................................102
When an Error Message is Displayed .......................................................................................103
Appendix A. Specifications .............................................................................. 106
Appendix B. Daily Check List........................................................................... 109
Appendix C. Periodic Check List...................................................................... 110
Appendix D. ECG DATA FORMAT .................................................................. 112
List of SCP-ECG Data Structures..............................................................................................112
Section Configurations...............................................................................................................112
Glossary ...................................................................................................... 115
Index ...................................................................................................... 117