Fukuda CardiMax Series User manual

ELECTROCARDIOGRAPH
ServiceManual
*
Before installation/maintenance,
read this service manual thoroughly.
*
After reading this service manual, store it in a safe place.

Fukuda Denshi Co., Ltd.
3-39-4 Hongo, Bunkyo-ku, Tokyo, Japan
©2017 Fukuda Denshi Co., Ltd.
No part of this document may be reproduced or transmitted in any form without the prior written
permission of Fukuda Denshi Co., Ltd.
If this manual has pages missing or out of order, contact Fukuda Denshi for replacement.
●Only physician or persons instructed by physicians are allowed to use the equipment.
●The information contained in this document is subject to change without notice due
to improvement in the equipment.
CAUTION
Fukuda Denshi UK
Unit 7, Genesis Business Park, Albert Drive, Woking, Surrey GU21 5RW, United Kingdom
This device bears the CE label in accordance with the provisions of Medical Device Directive
93/42/EEC.
This device bears the CE label in accordance with the provisions of RoHS Directive 2011/65/EU.

1
Model Name
FX-8200 Service Manual Revision History
Edition Revised Items Reason of the Revision Revised Date
1 - New Edition June, 2017
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2

1
Contents
Contents
Preface
Preface....................................................................................................................................i
About This Manual ..................................................................................................................i
Composition of This Manual.................................................................................................................i
Reminders to Use the Equipment Safely.................................................................................i
Safety Notations..................................................................................................................................ii
An Example of Safety Symbol.............................................................................................................ii
Labels for Assuring Safety .................................................................................................................iii
Symbols on the Equipment ................................................................................................................iii
Safety.................................................................................................................................................iv
Precautions when Using with Other Equipment.................................................................................iv
Optional Accessories...........................................................................................................................v
Application to Heart............................................................................................................................vi
Connecting the Power Cable..............................................................................................................vi
Leakage Current.................................................................................................................................vi
Precautions for Safe Operation of Medical Electrical Equipment.......................................................vi
Precautions Concerning the LAN.....................................................................................................viii
Storage, Transportation, and Disposal...............................................................................................ix
Cleaning and Disinfection....................................................................................................................x
Precautions for Safe Operation under Electromagnetic Influence ......................................................x
EMC Guidance...................................................................................................................................xi
Chapter 1 General Description
Features of this ECG..........................................................................................................1-1
Names of Parts and Their Functions.................................................................................. 1-1
Types and Functions of Operation Panel Keys.................................................................. 1-3
Specifications .....................................................................................................................1-4
Chapter 2 Operational Description
Hardware Overview............................................................................................................2-1
Operational Description...................................................................................................... 2-1
Primary Power Source ....................................................................................................................2-1
CPU Board...................................................................................................................................... 2-2
ECG Input Unit................................................................................................................................2-5
Operation Panel/Touch Panel Unit.................................................................................................. 2-6
Chapter 3 Wire Connection Diagram/Block Diagram
Wire Connection Diagram .................................................................................................. 3-1

2
Contents
Block Diagram ....................................................................................................................3-1
Pin Arrangement of External Connector.............................................................................3-2
Chapter 4 Spare Parts List
Chapter 5 Disassembly and Assembly Procedure
Power Supply Block............................................................................................................5-1
Paper Tray Block................................................................................................................5-1
Recorder Block (1/3)...........................................................................................................5-2
Recorder Block (2/3)...........................................................................................................5-3
Recorder Block (3/3)...........................................................................................................5-4
Upper Case Block (1/2) ......................................................................................................5-5
Upper Case Block (2/2) ......................................................................................................5-7
Lower Case Block...............................................................................................................5-8
General Assembly Diagram..............................................................................................5-10
External Appearance........................................................................................................5-10
Removing the Lower Case ...............................................................................................5-11
Removing the Recorder Block..........................................................................................5-12
Removing the CPU Board ................................................................................................5-13
Removing the Power Supply Unit.....................................................................................5-14
Removing the LCD ...........................................................................................................5-15
Chapter 6 Software Update
Software Updating Procedure.............................................................................................6-1
Chapter 7 Troubleshooting
When Malfunction Occurs...................................................................................................7-1
When the ECG Waveform is Unstable ............................................................................................7-1
When the Equipment does not Operate ..........................................................................................7-1
Messages and Remedies...................................................................................................7-2
Battery .............................................................................................................................................7-2
File...................................................................................................................................................7-3
Hardware Trouble...............................................................................................................7-3

3
Contents
Trouble at Startup............................................................................................................................ 7-4
Trouble during Operation ................................................................................................................ 7-5
Chapter 8 Maintenance
Self-Diagnosis (User Maintenance)....................................................................................8-1
User Maintenance Menu.................................................................................................................8-1
Test Pattern Waveform ................................................................................................................... 8-1
Date/Time........................................................................................................................................ 8-2
Status Display .................................................................................................................................8-3
General Test 1.................................................................................................................................8-3
General Test 2.................................................................................................................................8-5
Key Test..........................................................................................................................................8-6
Sound Test...................................................................................................................................... 8-6
Screen Test..................................................................................................................................... 8-7
Touch Panel Test............................................................................................................................ 8-7
Thermal Printing Test...................................................................................................................... 8-7
I/O Test............................................................................................................................................ 8-8
LCD Brightness Adjustment............................................................................................................ 8-8
Self-Diagnosis (Manufacturer Maintenance)......................................................................8-9
Manufacturer Maintenance Menu.................................................................................................... 8-9
AMP Status ................................................................................................................................... 8-10
Adjust Perforations........................................................................................................................8-10
MAC Address................................................................................................................................8-11
Adjust Touch Panel....................................................................................................................... 8-11
Screen Capture.............................................................................................................................8-11
Backup Battery Replacement...........................................................................................8-12
Main Battery (8PH-4/3A3700-H-J18) Replacement ......................................................... 8-13
Replacement of Display Unit Backlight.............................................................................8-15
Motor Replacement..........................................................................................................8-16
Thermal Print Head Replacement....................................................................................8-17
Adjusting the Thermal Recorder.......................................................................................8-17
Cleaning and Disinfecting.................................................................................................8-19
Cleaning the Equipment................................................................................................................8-19
Cleaning the Accessories.............................................................................................................. 8-20
Chapter 9 Maintenance and Inspection
Daily Check ........................................................................................................................9-1
Daily Check Procedure....................................................................................................................9-1
Periodic Check ...................................................................................................................9-2
Periodic Check Procedure...............................................................................................................9-2
Electrical Safety Inspection Procedure...............................................................................9-5
Safety Specification of this Equipment............................................................................................ 9-6
Earth Leakage Current....................................................................................................................9-6

4
Contents
Touch Current..................................................................................................................................9-7
Patient Leakage Current (From Patient Connection to Ground)......................................................9-7
Patient Leakage Current (When external voltage is applied to SIP/SOP).......................................9-7
Patient Leakage Current (When external voltage is applied to patient connection of Type F Applied
Part).................................................................................................................................................9-8
Patient Auxiliary Current..................................................................................................................9-8
Replacement of the Accessories........................................................................................9-8
Replacement Period of Consumable Parts......................................................................................9-8
Chapter 10 Appendix
Combination Example of Medical and Non-Medical Equipments.....................................10-1
Check List.........................................................................................................................10-1

1-1
Contents
Preface
Preface .............................................................................................i
About This Manual............................................................................i
Composition of This Manual...............................................................i
Reminders to Use the Equipment Safely..........................................i
Safety Notations ................................................................................ ii
An Example of Safety Symbol........................................................... ii
Labels for Assuring Safety.................................................................iii
Symbols on the Equipment................................................................iii
Safety ............................................................................................... iv
Precautions when Using with Other Equipment............................... iv
Optional Accessories.........................................................................v
Application to Heart.......................................................................... vi
Connecting the Power Cable............................................................ vi
Leakage Current............................................................................... vi
Precautions for Safe Operation of Medical Electrical Equipment..... vi
Precautions Concerning the LAN....................................................viii
Storage, Transportation, and Disposal............................................. ix
Cleaning and Disinfection..................................................................x
Precautions for Safe Operation under Electromagnetic Influence.....x
EMC Guidance ................................................................................. xi

Contents

i
Preface Preface
Preface
Preface
This manual contains technical information of the CardiMax series FX-8200 (hereinafter referred to as FX-8200)
intended for Fukuda Denshi service representatives and professional engineers. Before performing maintenance or
troubleshooting of the equipment, read the manual thoroughly to ensure proper and safe use of the equipment.
Make sure to follow the instructions in this manual when performing maintenance or adjustment of the equipment.
Failure to do so may lead to a serious accident.
About This Manual
Composition of This Manual
This service manual is intended for use by Fukuda Denshi service representative and professional engineers.
A technical description required for maintenance and repair of the FX-8200 is described.
This service manual is composed of the following chapters.
Reminders to Use the Equipment Safely
Please note the following statement when using this document. Please read "Reminders to Use the Equipment
Safely" carefully to ensure correct and safe use of the FX-8200. Make sure to follow the warnings and precautions
indicated below, as these are important messages related to safety.
DANGER
Donotmake changestothe medical electronic equipment.Otherwise, the safetyofFX-8200
cannot be ensured and the patient or the operator may be exposed to dangerous situation.
Chapter Title Description
Preface Introduction, Precautions for Safety
1.General Description General Description, Names of Parts and Their Functions, Specification
2.Operational Description Provides information on operational description of each block diagram.
3.Wire Connection Diagram/Block
Diagram Provides information on power supply, wiring diagram, cable diagram.
4.Spare Parts List Provides information of the spare parts list.
5.Disassembly and Assembly
Procedure Provides information of the assembly diagram.
6.Software Update Provides information on the software upgrading procedure.
7.Troubleshooting Provides information of the error messages and troubleshooting.
8.Maintenance Provides information of the cleaning procedure.
9. Maintenance and Inspection Provides information of the maintenance check items.
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Preface Reminders to Use the Equipment Safely
CAUTION
This service manual is intended for use by our service representative and technical experts.
Use proper tools and equipment for repair and assembly of FX-8200.
When removing the casing and working, it is necessary to check the safety items after
assembly. When removing the casing and working, please contact the concerned
department at the head office (Fukuda Denshil Service).
Please use the device on the desk with static electricity countermeasures to prevent
damage to electric parts due to static electricity. Please ensure that you work with a wrist
clip that is designed to discharge static electricity on the human body.
Place the removed PC board and parts in aconductive bagto protect itfrom static electricity,
liquid or shocks.
Ensure that you use replacement parts with FX-8200 specification.
For tightening and removing screws, please use a matching screwdriver. Ensure that you
use the screws that are specified.
When assembling, check that you have not forgotten to insert the connector or tighten the
screws. Also, after assembly, make sure that no foreign object is mixed in the connector part
of the equipment and the battery terminal.
Please handle FX-8200 according to the FX-8200 operation manual. Please refer to the
operation manual for precautions for use.
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
DANGER Indicates a potentially hazardous situation which, if not avoided, could 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.
This mark is attached to the main unit to protect the equipment from being damaged. The manual 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.
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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.

iii
Preface Reminders to Use the Equipment Safely
Labels for Assuring Safety
Warning (safety) labels are attached to this device to indicate precautions that need to be followed to ensure proper
and safe use of the device. Make sure to follow the instructions of the warning labels attached to this device when
operating the device. The positions of the labels attached to this device are indicated below.
CAUTION
Do not damage or erase the warning labels attached to the device. This warning label
contains important descriptions for handling and operating the equipment properly and
safely. If these labels are damaged or removed, the safety of the operator or the patient may
not be ensured because of missing information. Be careful not to damage the labels.
Symbols on the Equipment
The following is a list of symbols used on this equipment.
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Indicates failure to observe the instructions in this manual may pose a risk to the operator or the patient.
Indicates the relevant accompanying documents need to be referred to before operation.
Indicates a matter of Danger, Warning that calls attention for safety.
General Precaution: Indicates the need for cautious use.
Indicates an action to be done forcefully.
Indicates prohibited acts.
Indicates Type CF applied part with defibrillation-proof.
Indicates the potential equalization terminal.
Indicates the alternating current (AC) power supply.
Indicates the LAN port.
Indicates the USB port.
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.

iv
Preface Reminders to Use the Equipment Safely
Safety
Design Specifications
This equipment meets the requirements of IEC 60601-1(2005) +Am1(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, 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
Preventive Maintenance
The purpose of preventive maintenance is to ensure that the equipment is in safe operating conditions at alltimes 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 equipment
is in use.
When the equipment gets a strong impact due to dropping, etc.
When liquid spills on or into the equipment
When the equipment does not function normally
When the enclosure of the equipment is cracked, broken or damaged
Cables such as the power cable and lead wires have deteriorated in performance
Check all cables, equipments and accessories for damage, earth impedance, leakage current and accuracy.
Precautions when Using with Other Equipment
Non-Explosion Proof
Never operate the equipment where flammable gas or fluid such as anesthetic, oxygen, and hydrogen are used.
Explosion or fire may result.
Never operate the equipment in the presence of flammable anesthetics, high concentration of oxygen.
This may cause an explosion or fire.
Never use the equipment in the hyperbaric oxygen therapy chamber.
This may cause an explosion or fire.
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DANGER

v
Preface Reminders to Use the Equipment Safely
Do not ground with a gas pipe. Explosion or fire may result.
MRI
Before performing MRI scans, disconnect the electrodes connected to the patient.
Local heating due to induced electromotive force may cause burns to the patient. For details, refer to the
operation manual for the MRI testing device.
Defibrillator
When using this equipment with a defibrillator, use only the specified lead cable. The use of a lead cable other
than the specified defibrillation-proof type may damage the equipment or compromise safety when the
equipment is used along with a defibrillator.
Do not touch this equipment 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 equipment 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. Ifthe connection is incomplete, the current fromthe electrosurgical instrument may
run into the electrodes of this equipment 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.
Plug the electrosurgical instrument into a hospital grade outlet as far away as possible from the outlet of this
equipment. This will reduce interference from the electrosurgical instrument.
While using a high frequency surgical device, ECG cannot be displayed or recorded.
Other Equipments
Do not connect any unauthorized equipments.
Connect so that all equipments satisfy the conditions of operating environment.
Only the peripheral devices and cables specified by Fukuda Denshi should be connected to this equipment
using the specified procedure. For details of the connection procedure, contact your local Fukuda Denshi
service representative.
Contact your local Fukuda Denshi service representative when connecting with other equipments. The
connecting equipment must comply with the IEC or ISO standards, or equivalent safety level. Otherwise, it
may cause hazardous situation such as electric shock to the patient and operator.
When using with other equipments, the environment conditions (including transport/storage) of the connecting
equipments should be also observed. Failure to do so may damage the equipment. For the environment
conditions, refer to the operation manual of each equipment.
The operator should not touch the patient and the system composed of this equipment at the same time. It may
cause hazardous situation such as electric shock to the patient and operator.
Optional Accessories
WARNING
Use only the cables specified by Fukuda Denshi.Use of other cables may result in increase
in emission or decrease in immunity.
WARNING
WARNING
WARNING
WARNING
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Preface Reminders to Use the Equipment Safely
Application to Heart
CAUTION
This equipment 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 100/240 V AC hospital grade outlet. Use the battery when operating in areas with
no hospital grade outlet. Use an outlet with a power supply sufficient for the power
consumption of this device.
Multi-tap power outlets cannot be used as they may make the device unsafe for the patient
and 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
potentialdifference betweenthedevices. If potentialdifference 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 equipment. It may cause a fire hazard or electric shock.
Although this equipment is a transportable equipment 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 equipment 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.
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WARNING
CAUTION

vii
Preface Reminders to Use the Equipment Safely
Do not drop the equipment 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 equipment 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 equipment, other electrical appliances or surfaces such as
metal. This increases current leakage, which may result in danger to the patient.
Do not insert the USB memory in reverse direction or use excessive force when inserting it. It may damage
both the equipment 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.
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 off dirt on the surface of the touch-panel display with a soft cloth moistened with ethanol or with the
optional silicon cloth.
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 battery pack when operating the equipment on battery power. Otherwise, acid
leakage, overheating or explosion may occur.
Inspections
Perform daily checks to maintain safety.
Perform periodic checks once a year to maintain safety.
Check all cables, equipment, accessories, earth impedance, leakage current, and accuracy.
User should have a thorough knowledge of the operation before using this system.
For installation and storage of the equipment, 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.
Take care to ensure stability with no inclination, vibration, or impact (including during transportation). Do not
install on an unstable surface.
Place the equipment 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 equipment 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 electrical equipment, do not place other general electrical equipments within
1.5 meters from areas where patients are present.
Before operating the equipment
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 equipment.
Make sure the power system has adequate earth ground.
Ensure that all cables are connected properly and safely.
During operation of the system
CAUTION
CAUTION
CAUTION
CAUTION

viii
Preface Reminders to Use the Equipment Safely
Make sure that the electrodes and lead cable tips do not touch metal areas of the bed or other conductive items.
Always observe the equipment and patient to ensure safe operation.
If you notice any abnormalities in the equipment or the patient, stop the operation or take other appropriate
measures to ensure the safety of the patient.
Do not allow the patient to come in contact with the equipment.
Do not block the vents. This may result in overheating or a fire hazard.
Do not drop the equipment or subject it to strong impact or vibration. It may result in electric shock or a fire
hazard. If the equipment is dropped or damaged, contact your local Fukuda Denshi service representative .
Do not pull strongly on the cables such as lead cable.
After using the equipment
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 equipment clean to ensure proper operation for the next use.
If the equipment is damaged, users should not attempt repair. Label the unit "OUT OF ORDER" and contact
your nearest service representative.
Do not remodel the equipment.
If using a defibrillator while using this equipment, check the paste volume, output energy, etc. to prevent the
risk of burn injury of the patient. Also, verify that each equipment is properly grounded.
USB Memory
Use a media specified by Fukuda Denshi. Using unspecified media may cause failure to the equipment, such
as damage or loss of ECG data. The warranty does not cover data 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 equipment 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 Concerning the LAN
Inspections
When connecting this equipment to the network (LAN), the LAN cable should be not longer than 100 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 equipment 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 equipment 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 equipment 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.
CAUTION
CAUTION
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CAUTION
CAUTION

ix
Preface Reminders to Use the Equipment Safely
Precautions when Using with Wireless LAN Adapter
When using a wireless LAN, make sure to check the operation of any medical electrical equipments nearby.
Stop using the wireless LAN immediately if unexpected waveform noise occurs or there is interference from
surrounding equipment.
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, which may damage the wireless LAN
adapter. Make sure to follow the precautions below to protect the wireless LAN adapter and this equipment
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
CAUTION
Do not open the housing.
Wipe off dirt on the surface of the housing with a soft cloth moistened with ethanol or with
the optional silicon cloth.
Perform daily checks to maintain safety.
Perform regular inspections every 12 months to maintain safety.
Check all cables, equipments, accessories, earth impedance, leakage current, and
accuracy.
If the device has not been used for a while, make sure to check that the device operates
properly and safely before using it.
Be careful not to let liquid such as alcohol get into the equipment.
Transportation
CAUTION
Pack this device in packaging specified by Fukuda Denshi when transporting.
The device does not have handles. Carry it by holding it with both hands.
CAUTION
CAUTION
CAUTION
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Preface Reminders to Use the Equipment Safely
Disposing the Equipment
WARNING
When disposing of this device and accessories, commission disposal to a specialist waste
disposal contractor.
Cleaning and Disinfection
Electrodes, Lead Cables
Disinfect the electrodes and lead cables between uses by wiping with cotton or a cloth soaked in an alcohol
solution.Then, wipe with a soft cloth.
Infection can occur via electrodes. The electrodes must therefore always be kept clean by cleaning and
disinfecting.
Do not reuse disposable electrodes designed for single use. This may cause infection.
Do not heat-disinfect the electrodes with water, steam or air.
Use only specified cleaning fluid when cleaning the electrodes.
Main Unit
Wipe the equipment with a cloth soaked in a household cleaning solution diluted with water.
Do not use ether or benzin as they may damage the enclosure.
Wipe with cotton or a cloth soaked in alcohol solution.Then, wipe with a soft cloth.
Thermal head
Printing residue adhering to the thermal print head lowers the print quality. Use a cotton swab moistened in
alcohol to wipe away print residue.
Never use sandpaper as it will damage the heating element.
System products
Clean the connected equipments according to the instructions in their respective manuals.
Precautions for Safe Operation under Electromagnetic Influence
Measures to ensure Electromagnetic Compatibility (EMC)
While this device complies with the IEC60601-1-2 (2007)/AC (2010) and IEC 60601-2-25 (2011) safety
standards, malfunctions may occur if there are strong electromagnetic waves nearby that exceed the limit.
Please take the necessary countermeasures in such cases.
Effect of electromagnetic emission
The use of mobile phones may cause malfunction. Mobile phones and radio sets should be turned OFF in the
facility where the medical device is located.
The use of microwave therapy devices nearby or in an adjacent room may cause malfunction or damage to the
ECG. Keep these devices a sufficient distance apart according to the Guidance on Electromagnetic
Compatibility.
Effect of burst and conducted electromagnetic waves
High frequency noise interference may occur from other devices through the power outlet. Check the source
of the noise and stop the device that is causing the noise if it is possible to do so. If it cannot be stopped, take
countermeasures to change the path of the noise, such as using a filtering device.
Malfunction due to static electricity
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WARNING
CAUTION
CAUTION
CAUTION
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CAUTION
CAUTION
CAUTION
CAUTION