cardimax_series

Service Manual
ELECTROCARDIOGRAPH
* Before installation/maintenance,
read this service manual thoroughly.
* After reading this service manual, store it in a safe place.
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.
Fukuda Denshi UK
Unit 7, Genesis Business Park, Albert Drive, Woking, Surrey GU21 5RW, United Kingdom
Fukuda Denshi Co., Ltd.

3-39-4 Hongo, Bunkyo-ku, Tokyo, Japan
CAUTION
● Only physician or persons instructed by physicians are allowed to use the equipment.
● The information contained in this document is subject to change without notice due
to improvement in the equipment.
© 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.
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Model Name
FX-8200 Service Manual Revision History
Edition Revised Items Reason of the Revision Revised Date
1 - New Edition June, 2017
1
2
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
1
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
2
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
3
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
4
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
1-1
Contents
Preface Preface
Preface
Preface
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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

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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.
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 Provides information on power supply, wiring diagram, cable diagram.
Diagram
4.Spare Parts List Provides information of the spare parts list.
5.Disassembly and Assembly Provides information of the assembly diagram.

Procedure
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.
Reminders to Use the Equipment Safely

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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
 Do not make changes to the medical electronic equipment. Otherwise, the safety of FX-8200
cannot be ensured and the patient or the operator may be exposed to dangerous situation.
i
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 a conductive bag to protect it from 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
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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.
DANGER Indicates a potentially hazardous situation which, if not avoided, could result in death, serious injury, or fire.
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 minor or moderate injury, or
CAUTION 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.
A note is not related to product safety, but provides information on proper use to prevent incorrect operation
NOTE
or malfunction.
An Example of Safety Symbol

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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.
ii
Labels for Assuring Safety

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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

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The following is a list of symbols used on this equipment.
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.
iii
Safety
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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
7 Target
Neonate, Child, Adult
Preventive Maintenance
The purpose of preventive maintenance is to ensure that the equipment is in safe operating conditions at all times and
prevent potential future problems.
Perform preventive maintenance at least once every three months.
Inspect the main unit and all connectors and cables for any external damage.
Perform maintenance if one of the following should occur.Do not repair or perform maintenance when the 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

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DANGER 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.
iv
 Do not ground with a gas pipe. Explosion or fire may result.

WARNING 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.
WARNING 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.
WARNING 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
can be sufficiently secured. If the connection is incomplete, the current from the 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.
WARNING 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
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WARNING
 Use only the cables specified by Fukuda Denshi.Use of other cables may result in increase
in emission or decrease in immunity.
v
Application to Heart
bl5645
CAUTION
 This equipment is a type CF applied part, but it is not intended for direct applications to
patients' heart.
Connecting the Power Cable

bl5648
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
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CAUTION
 If multiple devices are plugged into the same outlet, this may cause greater current leakage
in the devices, causing potential danger to patients.
 This danger may occur if the patient has a pacemaker or other heart equipment using
electrical stimulation. Take particular care with safety when recording ECGs in these
conditions. Current leakage needs to be below the allowable limit for safety purposes.
Follow the instructions in the operation manual of the pacemaker or other heart equipment
using electrical stimulation.
 When using this device with other devices, perform equipotential grounding to prevent
potential difference between the devices. If potential difference occurs between the devices,
danger may result to the patient and operator.
 Do not touch the electrodes of this device or the conductive part of the attached connectors.
Touching these may cause a danger to the patient.
Precautions for Safe Operation of Medical Electrical Equipment

bl5650
WARNING
 Do not disassemble or modify this equipment. It may cause a fire hazard or electric shock.
CAUTION
 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.
vi
 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.
CAUTION 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.
CAUTION
 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.
CAUTION 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.
CAUTION During operation of the system
vii
 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.
CAUTION 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.
CAUTION 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

bl5651
CAUTION Inspections
 When connecting this equipment to the network (LAN), the LAN cable should be not longer than 100 m.
CAUTION 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.
viii
CAUTION 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.
CAUTION 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.
CAUTION 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

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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.
ix
Disposing the Equipment

WARNING
 When disposing of this device and accessories, commission disposal to a specialist waste
disposal contractor.
Cleaning and Disinfection

bl5654
WARNING 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.
CAUTION 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.
CAUTION 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.
CAUTION System products
 Clean the connected equipments according to the instructions in their respective manuals.
Precautions for Safe Operation under Electromagnetic Influence

bl5658
CAUTION 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.
CAUTION 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.
CAUTION 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.
CAUTION Malfunction due to static electricity
x
 Malfunctions may be caused by the discharge of static electricity in dry environments (rooms), such as in
winter. Humidify the room, or discharge the static electricity from the operator and the patient before using the
equipment.
CAUTION Malfunction due to surge (lightning)
 A lightning nearby may induce excessive voltage to the equipment. Unplug the power cable from the AC outlet
in such situation.
 Use the uninterruptible power supply system if available.
EMC Guidance
bl5662
This equipment complies with IEC 60601-1-2 (2007)/AC (2010) and IEC 60601-2-25 (2011) safety standards.
However, if portable transmitter or wireless LAN equipment is used extremely nearby, the electromagnetic influence
may largely exceed the compliance level and may cause unexpected phenomenon such as noise interference on the
waveform, etc.
This equipment should be used in a location specified by each medical institution.
If any unexpected noise interference on the waveform or failure to the peripheral device occurs, stop using the
equipment and follow the instruction of the technical engineer.
The following is the information relating to EMC (Electromagnetic Compatibility).
(When using the FX-8200, verify that it is used within the environment specified below.)
Compliance to the Electromagnetic Emissions

The FX-8200 is intended for use in the electromagnetic environment specified below.
Emission Test Compliance Electromagnetic Environment/Guidance
RF emission Group 1 The FX-8200 uses RF energy that is necessary for the internal functioning of
CISPR 11 the equipment itself.Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
RF emission Class B The FX-8200 is suitable for use in all structures, including structures of
CISPR 11 ordinary homes, and those directly connected to the public low-voltage
power supply network that supplies structures used for domestic purposes.
Harmonic distortion Class A
IEC 61000-3-2(2005),
Am1 (2008), Am2 (2009)
Power supply voltage

fluctuation and flicker
IEC 61000-3-3 (2013)
xi
Compliance to the Electromagnetic Immunity (1)

The FX-8200 is intended for use in the electromagnetic environment specified below. The customer or the user of
the FX-8200 should verify that it is used in such an environment.
IEC 60601-1-2
Immunity Test IEC 60601-2-25 Compliance Level Electromagnetic Environment/Guidance
Test Level
Electrostatic discharge Contact: ±2, 4, 6 kV Contact: ±2, 4, 6 kV Floors should be wood, concrete, or ceramic
(ESD): In air: ±2, 4, 8 kV In air: ±2, 4, 8 kV tile.If floors are covered with synthetic material,
IEC 61000-4-2 the relative humidity should be at least 30%.
Electrical fast transient / ±2kV: power supply lines ±2kV: power supply lines Mains power quality should be that of a typical
burst ±1kV for input/output ±1kV for input/output commercial or hospital environment.
IEC 61000-4-4 lines lines
Surge: ±0.5,1kV: ±0.5,1kV: Mains power quality should be that of a typical

IEC 61000-4-5 Differential Mode Differential Mode commercial or hospital environment.
±0.5,1,2kV: ±0.5,1,2kV:
Common Mode Common Mode
Power supply input For 0.5 cycles: For 0.5 cycles: <5% UT Mains power quality should be that of a typical
lines < 5% UT (> 95% UT drop) commercial or hospital environment.
fluctuation in input (> 95% UT drop) For 5 cycles: If it is required to continuously operate the FX-
supply line For 5 cycles: 40% UT 8200 during power failure, it is recommended
IEC 61000-4-11 40% UT (60%UT drop) to operate on an uninterrupted power supply.
(60%UT drop) For 25 cycles:
For 25 cycles: 70% UT
70% UT (30%UT drop)
(30%UT drop) For 5 seconds:
For 5 seconds: < 5% UT
< 5% UT (95%UT drop)
(95%UT drop)
Magnetic field of 3A/m 3A/m Power frequency magnetic fields should be at

commercial frequency levels characteristic of a typical location in a
(50/60Hz) magnetic typical commercial or hospital environment.
field
IEC 61000-4-8
Remarks: UT is the AC mains voltage prior to application of the test level.
xii
Compliance to the Electromagnetic Immunity (2)

The FX-8200 is intended for use in the electromagnetic environment specified below. The customer or the user of
the FX-8200 should verify that it is used in such an environment.
IEC 60601-1-2
Compliance
Immunity Test IEC 60601-2-25 Electromagnetic Environment/Guidance
Level
Test Level
Conducted RF 3Vrms 3Vrms Portable and mobile RF communications equipment should be

IEC 61000-4-6 150kHz to 80MHz 3V/m used no closer to any part of this device, including cables, than
Radiated RF 3V/m the recommended separation distance calculated from the
IEC 61000-4-3 80MHz to 2.5 GHz equation applicable to the frequency of the transmitter.
Recommended separation distance:
d = 1.2 26MHz to 80MHz
d = 1.2 80MHz to 800MHz
d = 2.3 800MHz to 2.5GHz
Where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer and d is
the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey*1, should be less than the
compliance level in each frequency range*2.
Interference may occur in the vicinity of equipment marked with
the following symbol:
Note 1: At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast can not be predicted
theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered.
If the measured field strength in the location where the FX-8200 is used exceeds the applicable RF
compliance level, the FX-8200 should be monitored to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the FX-8200.
b: Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.
Recommended Separation Distances between Portable and Mobile RF Communications

Equipment and the FX-8200 System
The FX-8200 is intended for use in an electromagnetic environment where RF emission interference is controlled.
When using the product, electromagnetic interference can be prevented by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the FX-8200 as recommended below,
according to the maximum output power of the communications equipment.
Separation Distance (m) based on Transmitter Frequency
Rated Maximum
Output Power of 26MHz to 80MHz 80MHz to 800MHz 800MHz to 2.5 GHz
Transmitter(W) d = 1.2 d = 1.2 d = 2.3
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 d in meters (m) can be
determined using the equation applicable to the frequency of the transmitter, where P in this equation is the rated maximum output
power in watts (W) of the transmitter provided by the manufacturer.
Note 1: At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations.

Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
xiii
Interference by Electrosurgical Instrument

This equipment is protected against any malfunctions that may be caused by the usage with the electrosurgical
instrument specified below.
Immunity IEC 60601-2-25

Compliance Level Electromagnetic Environment/Guidance
Test Test Level
Incision mode Output power 300 W Output power 300 W When an electrosurgical instrument generates high-
frequency energy, the noise level of the displayed/
Coagulation Output power 100 W Output power 100 W recorded waveforms increase, but it returns to
mode
original level within 10 seconds.
If the waveforms during the generation of high-
frequency energy are analyzed, effective analysis
result may not be obtained.
xiv
Chapter 1 General Description Contents
Features of this ECG ................................................................... 1-1

Names of Parts and Their Functions ........................................... 1-1
Types and Functions of Operation Panel Keys ........................... 1-4
Specifications .............................................................................. 1-5
1-1
Chapter 1 General Description Contents
Chapter 1 General Description Features of this ECG

bl5993
This chapter explains the overview of CardiMax Series FX-8200, the name of each part and the specifications.
Features of this ECG

bl5671
The CardiMax series FX-8200 measures a standard 12-lead electrocardiogram (ECG) with high accuracy and
performs processing of classification of findings. Analysis results and ECG can be recorded and printed. ECG data
can be stored on a USB memory stick.
Examinations that can be conducted by this ECG

Type of examinations Description
Standard ECG examinations 12-lead examinations can be carried out.
Arrhythmia ECG Long 3-lead arrhythmia examination can be carried out.
Rhythm Measurement One-lead R-R rhythm measurement can be carried out.
Names of Parts and Their Functions

bl5674
This section describes parts and their functions of this equipment.
WARNING
 Contact your local Fukuda Denshi service representative when connecting with other
equipments.
Otherwise, it may cause hazardous situation such as electric shock to the patient and
operator.
 Make sure to use the supplied 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.
CAUTION
 Do not bend, drop, or apply impact to the USB memory.
 Do not apply impact to the equipment while the USB memory is in operation. It may damage
the data or break the media.
 Do not touch the terminal parts of the USB memory with your hands or metal objects.
 Caution about the warning labels attached to the equipment
 These warning labels provide important information on proper and safe handling of the
equipment.
 Do not scratch, damage, or erase the warning labels attached to the device.
1-1
Chapter 1 General Description Names of Parts and Their Functions
Front view
1
2
3
4
6
5 7
8
9
10
Rear view, bottom view
11
12 13
14
1 Paper tray
The recording paper is loaded inside.
2 Thermal head
Prints ECG waveforms and measurement values on the recording paper.
3 AC Power Indicator (Blue)
When connected to an AC outlet, the indicator will light.
4 Charge Indicator (Blue/Orange)
During charging, it will light in blue. When charging is completed, it will turn off. If an error occurs during charging,
it will light in orange.
5 Control Panel
Buttons for turning ON/OFF the power or starting the ECG recording are located.
6 LCD Monitor
Displays ECG waveforms and patient information.
NOTE
 Although the color LCD utilizes highly advanced technologies, occasionally, there may be
a few pixels which do not light (dots) or constantly light. Temperature changes may also
cause some irregularities due to the characteristics of the LCD. Please note that this is
not an equipment failure.
 Remove dust and stains from the LCD screen by wiping with a cloth that has been
dampened in ethanol or other alcohol and thoroughly wrung out.
7 Vents
Used as air inlets and outlets.
1-2
Chapter 1 General Description Names of Parts and Their Functions
NOTE
 To ensure the necessary air flow, do not block these vents. A minimum space of 5 cm is
required between the back/sides of the equipment and the wall.
8 ECG connector (ECG waveform input)

Connects the ECG patient cable.
9 LAN connector
Connects to the DMS (data management system) via LAN.
10 USB connectors 1 to 2
Connects a USB memory (optional) or external device such as a barcode reader.
NOTE
 Do not unplug a USB memory or turn OFF the power while the USB memory is in
operation.
11 AC Power Supply Connector

Connects the power cable.
To disconnect from the power source, unplug the power cable from this connector.
12 Potential Equalization Terminal
Connects an equipotential line.
13 Battery Insertion Slot
Insert the optional internal battery here.
14 Wireless LAN Adapter Slot
It is located inside the battery cover. Insert the optional wireless LAN adapter here.
1-3
Chapter 1 General Description Types and Functions of Operation Panel Keys
Types and Functions of Operation Panel Keys

bl5675
The operation panel buttons are used for operation. The function of each button on the operation panel is as follows:
1 2 3 4 5 6 7
1 Power Supply Key

Turns ON/OFF the power. Hold down the button 2 seconds or longer to turn off.
2 Lead Key
Changes the lead during an ECG examination Moves the cursor to left or right while typing.
3 Sensitivity Key
Changes the sensitivity during an ECG examination
4 Reset Key
Resets the waveforms.
5 1mV key
Inserts a calibrated waveforms.
6 Review key
Starts/stops printing a review during an ECG examination.
7 Start/Stop key
Starts/stops recording. When pressed during recording, recording stops.
1-4
Chapter 1 General Description Specifications
Specifications
bl5882
ECG
Control Panel Power key, START/STOP key, Review key, Reset Key, 1 mV key, Leady
key, Sensitivity key
Standard sensitivity 10 mm/mV
Sensitivity changes 1/4, 1/2, 1, 2, Auto
Stability of sensitivity Temporal change within ±3%

Accuracy of Sensitivity: Error: +/- 5%
Detection range/accuracy of heart rate 30-300 bpm, Error: ±2 or less
Input impedance 2.5 MΩ and above
Differential and synchronous offset voltage (Voltage ±600 mV and above

between electrode and patient’s skin)
Recovery Time Within 5 seconds
Tolerable overload voltage 1 Vp-p, 10 seconds

Sine wave characteristics 0.05 Hz to 250 Hz
Low frequency characteristics (time constant) 3.2 s or more
Common-Mode Signal Suppression 103 dB and above (2 mm [p-p] and below at sensitivity level 1)
Leads Standard 12-lead
Lead selector Error: within 5%
Skew between leads 0 sec.

Noise level 30μV (p-p) and below (input conversion)
Filter AC filter: -20 dB or less at 50 Hz or 60 Hz

Muscle filter: -3 dB (-6 dB/oct) or less at 35 Hz or 25 Hz
Drift: -3 dB (-6 dB/oct) or less at 0.25 Hz or 0.5 Hz
Printing Thermal Head Method
Printing Speed 5, 10, 12.5, 25, 50 mm/s ±3% or less
Printing Density Amplitude direction: 8 dots/mm

Direction of the time axis: 1 ms (25 mm/s or less), 500 μs (500 mm/s)
Printing channel 3, 6 ch
Appropriate chart paper OP-222TE (with grids, Z-fold paper)
Display Color LCD, 800 x 480 dots (with LED backlight)
LED AC power supply LED, Battery Charging LED
A/D conversion 18-bit
Sampling Rate 8000 samples/sec.
LAN port Conforms to IEEE802.3u 100BASE-TX

(The cable must be within 50 m.)
Filing USB Memory
USB port Compatible with USB2.0 Full Speed, 3 ch bl5883
1-5
Chapter 1 General Description Specifications
Analysis Processing Unit

Patient Information ID number, age, gender, height, weight, etc.
Basic Measurement Heart rate, RR, PR, QRS, QT time, QTcB, QTcF, electric axis, SV1, RV5 (6)
Interpretations and Codes Approximately 130 types
Minnesota Code Approximately 130 types
bl5884 Grade Judgment 4 types
Overall Equipment
Safety Class I equipment and internal power supply equipment
Type CF Applied Part
Cardiac defibrillator recovery time Within 10 seconds
Power Supply AC power: 100/240 V AC 50/60 Hz

DC power: 9.6 V DC (Battery pack)
Power Consumption 70 VA (AC), 40 W (DC)
On-board 12 V power supply Unusable
Dimensions Approximately 260 mm (W) × 206mm (D) × 66mm (H)
Weight Approximately 1.8 kg (main unit only)

bl5885 Approximately 2.3 kg (including options such as battery and wireless LAN adapter)
Operating Environments
Temperature 10°C to 40°C
Humidity 25% to 95% (Non-condensing)
Atmospheric Pressure 80 kPa to 106 kPa
Transport/Storage Environment (Overall Equipment)

Temperature -10°C to +60°C
Transport/Storage Environment (Specified Products: Chart Paper, Battery Pack)

Temperature -10°C to +50°C
1-6
Chapter 2 Operational Description Contents
Hardware Overview ..................................................................... 2-1

Operational Description ............................................................... 2-1
Primary Power Source....................................................................2-1
CPU Board .....................................................................................2-2
ECG Input Unit ...............................................................................2-6
Operation Panel/Touch Panel Unit .................................................2-6
2-1
Chapter 2 Operational Description Contents
Chapter 2 Operational Description Hardware Overview

Hardware Overview
bl5929
The ECG waveform is inputted through the lead cable and printed on the recording paper.
A detailed ECG is displayed on the high-precision color LCD.
An overview diagram of the FX-8200 including the optional accessories is shown below.The dashed lines indicate
the optional accessories.
Patient
USB Memory
Card Reader
Electrocardiopraph
Barcode Reader DMS
USB Wireless
LAN Adapter
Battery
CAUTION
 Do not change the jumper setting or switch position on the main unit board.
 The equipment operation may become unstable or may cease.
Operational Description
Primary Power Source

bl5930
The functional block diagram of the primary power source is shown below.
90 V to 264 V AC +18 V
47 Hz to 63 Hz
Incoming Current
Prevention Circuit +18 V
Generation
Fuse Part
Line Filter
Fuse Switching Feedback
Part Part
90 V AC to 264 V AC can be input to the primary power source.

+18 V DC is output by rectification and switching control.
2-1
Chapter 2 Operational Description Operational Description
CPU Board
bl5931
Overview of CPU Board

The block diagram of the CPU board is shown below.
CPU Board
Isolator
DDR2
CN
LAN
SDRAM Bus
CN
USB x 3
CPU
i.MX515
800MHz
Main Bus
Isolator
ECG
CN
Amp(12L)
FPGA Flash
Memory
Motor
Driver
Local
Power Supply
And
Controller
CN
CN
The CPU board controls the following functions.

Display : Controls the display on the LCD and external monitor.The LCD signal is transmitted through the
operation panel. The external monitor is connected through the connector board.
USB Communication : Controls the USB memory communication.
LAN Communication : Controls the 10/100Base-T compliant LAN communication.
Sound : Controls the speaker generating a warning tone, etc.Connects to the speaker.
2-2
Secondary Power Source

The block diagram of the secondary power source circuit is shown below.
㻡㼂㼋㻿㼀㻮
㻸㻰㻻㻌㻞㻜㼙㻭㻸㼛㼓㼕㼏㻚㻚㻚㼑㼠㼏
㻗㻝㻤㼂㻰㻯
㼁㻿㻮㻌㻼㼛㼞㼠
㻺㼕㻹㻴㻌㼏㼔㼍㼞㼓㼑㼞㻌㼣㼕㼠㼔㻌
㻿㼥㼟㼠㼑㼙㻌㻼㼛㼣㼑㼞㻌㻿㼑㼘㼑㼏㼠㼛㼞㼕㻚㻹㼄㻡㻝㻌㻘㻌㻲㼘㼍㼟㼔㻘㻌㻰㻰㻾㻞㻘
㻝㻚㻤㼂㼋㻯㻼㼁
㻰㻯㻛㻰㻯㻌㻝㻚㻢㻚㻭㻱㻹㻵㻚㻚㻚㼑㼠㼏
㻝㻚㻞㻞㻡㼂㼋㻯㻼㼁㼕㻚㻹㼄㻡㻝㻌㻵㻛㻻
㻻㼚㼘㼥㻌㻯㼔㼍㼞㼓㼕㼚㼓㻰㻯㻛㻰㻯㻌㻜㻚㻤㻭
㻗㻤㻚㻜䡚㻗㻥㻚㻢㼂㻰㻯㻝㻚㻤㻣㻡㻭㻬㻗㻥㻚㻢㼂㻰㻯㻝㻚㻝㼂㼋㻯㻼㼁㼕㻚㻹㼄㻡㻝㻌㻯㼛㼞㼑
㻰㻯㻛㻰㻯㻌㻜㻚㻤㻭
㻝㻚㻞㼂㼋㻲㻼㻳㻭㼕㻚㻹㼄㻡㻝㻌㻼㻸㻸㻚㻚㻚㼑㼠㼏
㻸㻰㻻㻌㻜㻚㻞㻭
㻞㻚㻢㼂㼋㻯㻼㼁㼕㻚㻹㼄㻡㻝㻌㼁㻿㻮㻼㻴㼅㻚㻚㻚㼑㼠㼏
㻸㻰㻻㻌㻜㻚㻞㻭
㻡㼂㻟㻚㻟㼂㼋㻱㻺
㻠㻌㻯㼑㼘㼘㻌㻺㼕㻹㻴
㻟㻚㻟㼂
㻰㻯㻛㻰㻯㻌㻟㻚㻜㻭
㻥㻚㻢㼂
㻡㼂㻸㻯㻰㻌㼎㼍㼏㼗㻌㼘㼕㼓㼔㼠
㻰㻯㻛㻰㻯㻌㻠㻚㻡㻭㻰㻯㻛㻰㻯㻌㻜㻚㻞㻭
㻸㼛㼓㼕㼏㻚㻚㻚㼑㼠㼏
㻞㻠㼂
㻰㻯㻛㻰㻯㻌㻞㻚㻜㻭㼀㼔㼑㼞㼙㼍㼘㻌㻴㼑㼍㼐㻌㻼㼞㼕㼚㼠㼑㼞
㻹㼛㼠㼛㼞㻌㻰㼞㼕㼢㼑㼞
㼂㻯㻻㻹
㻟㻚㻟㼂㻰㻯㻛㻰㻯㻌㻟㻜㼙㻭
㼂㻳㻸
㻰㻯㻛㻰㻯㻌㻜㻚㻡㻭㻰㻯㻛㻰㻯㻌㻟㼙㻭
㼂㻳㻴㻸㻯㻰㻌㼘㼛㼓㼕㼏
㻰㻯㻛㻰㻯㻌㻟㼙㻭
㻭㼂㻰㻰
㻰㻯㻛㻰㻯㻌㻤㻜㼙㻭
The original power is supplied from the primary power source unit or battery unit.
To prevent from not being able to turn ON/OFF the power caused by CPU runaway, the power ON process is
performed by the hardware.
The final process of power OFF and power OFF process in case of CPU runaway are also performed by the hardware.
To clear the flip-flop operation latching the pressing of power supply key, the battery low voltage detection signal is
linked.
Bus I/F Unit

The block diagram of the bus I/F unit is shown below.
32 bit bus
CPU DDR2 SDRAM
128MB × 2
16 bit bus
FPGA FLASH ROM

128MB
The main bus is connected to the FPGA and FLASH ROM, and has a bus width of 16 bits.
DDR2 SDRAM is connected to the SDRAM dedicated 32-bit bus.
2-3
Display Unit
The block diagram of the display unit is shown below.
CPU
RGB data Transmitter LCD
Thermal Print Head Control Unit

The block diagram of the thermal print head control unit is shown below.
㻼㻯㻮㻙㻣㻣㻤㻡㻌㻌
㻌㻯㻼㼁㻌
㻌
Thermal Print Head

㻌
16 bit Bus
Temperature Data
㻌
Print
㻌 Data
㻲㻼㻳㻭㻌
OVH
Detection
Data, Strobe
Power
Supply
24V
Power Supply
The thermal printing process is as follows.

The CPU sets the drawing data to the internal RAM of FPGA at the interrupt timing from the FPGA.
The FPGA transfers the drawing data to the thermal print head corresponding to the printing speed.
The CPU reads the thermal print head temperature, and outputs it to the FPGA as strobe data taking the temperature
condition into consideration.
The FPGA monitors overheating, paper end, paper tray up condition, and when these are detected, the printing is
stopped by ceasing the data transmission and thermal print head strobe signal.
Motor Drive Unit

The block diagram of the motor drive unit is shown below.
㻼㻯㻮㻙㻣㻣㻤㻡㻌㻌
㻯㻼㼁㻌
Print Speed Data

Motor
Motor Driver Drive Signal
Drive Pulse
㻲㻼㻳㻭㻌 Stepping
Motor Driver Motor
Motor Driver
Primary Power Source Power Supply
The motor is controlled as follows.

The CPU sets the printing speed data for the FPGA.
When paper end or tray up is not detected, FPGA outputs the motor pulse to the motor driver based on the set data.
The motor driver drives the stepping motor with the frequency and current value according to the drive pulse.
In addition, the FPGA controls the motor driver power supply, and supplies appropriate voltage according to the
printing speed to the motor driver.
2-4
Sensor Drive Unit

The block diagram of the sensor drive unit is shown below.
Detection
㻲㻼㻳㻭㻌 Signal Threshold
Compare Amplify
㻮㼡㼒㼒㻚㻌
Photo
Sensor Drive Transistor Sensor
Pulse Output
Paper
Paper
䝨䞊䝟㻌
The paper end sensor and mark sensor are controlled as follows.
The sensor drive pulse is output from the FPGA and input to the phototransistor via buffer.
The sensor output signal with the voltage corresponding to the reflection degree, is amplified by the amplifier and
compared with the threshold value.The compared detected signal is inputted to the FPGA, and after the chattering
process in the FPGA, paper end and mark status are fixed.These information are used for motor and thermal signal,
and transferred to the CPU as detected result.
USB I/F Unit

The block diagram of the USB I/F unit is shown below.
USB Power
㻌
Control Device
㻌
㻌㼁㻿㻮㻌
㻌 Port 1㻌
㻌
㻯㻼㼁㻌 USB
Transceiver㻌㼁㻿㻮㻌㻴㼁㻮㻌
㼁㻿㻮㻌
Port 2㻌
㼁㻿㻮㻌
Port 3㻌
The USB I/F unit has a full speed compliant circuit for three ports.A data communication with the CPU is performed
via dedicated transceiver.Communication with each port is performed by USB hub device.
A USB power control device is mounted to protect against overcurrent.When overcurrent is detected, the power
supply to the USB device is ceased, and transfers the overcurrent status signal to the CPU.
Sound I/F Unit

The block diagram of the sound I/F unit is shown below.
㻌㻼㼃㻹㻌
㻯㻼㼁㻌
㻌
Piezoelectric Buzzer
The sound source data from the CPU and FPGA is transmitted to the piezoelectric buzzer as PWM signal.
2-5
ECG Input Unit

bl5932
The functional block diagram of the ECG input unit is shown below.
AMP Block
Input Differential Photo Isolator
Protector Amplifier A/D Converter
R
SPI SPI
L
C1
C2
+5VF CPU Block
+5V
+2.5VA
C3 Isolation
Power 100KHz
C4
Patient 20bit A/D
-2.5VA
Input C5
Connector C6
C7
C8
C9
Unmount
RF
12bit A/D
ch1
E25F
The ECG signal input from the patient input connector passes through the input protector and enters the differential
amplifier. Here, the signals of the right hand, left hand, chest 1 to chest 6 are differentially amplified with the left
foot signal.
The output of the differential amplifier is converted to a digital signal by the respective A/D converter. The
digitalized ECG signal is transferred to the CPU board by SPI communication.
The ECG AMP block is electrically isolated by photo isolater and isolation power.
Operation Panel/Touch Panel Unit

bl5933
The block diagram of the operation panel/touch panel unit is shown below.
LCD
Touch Panel
LED
TP controller
Key Panel
CPU Key Sheet

CPU Board
A resistive touch panel is used.The touch panel is a 7-inch 4-wire type, and transmits the data to the CPU by the touch
controller with I2C I/F.
The key data of operation panel is transmitted to the CPU with I2C I/F.
The statuses of AC power supply and battery are indicated by the key sheet LED.
2-6
Chapter 3 Wire Connection Diagram/Block Diagram Contents
Chapter 3 Wire Connection Diagram/Block

Diagram
Wire Connection Diagram............................................................ 3-1

Block Diagram ............................................................................. 3-2
Pin Arrangement of External Connector ...................................... 3-3
3-1
Chapter 3 Wire Connection Diagram/Block Diagram Contents
Chapter 3 Wire Connection Diagram/Block Diagram Wire Connection Diagram
Chapter 3 Wire Connection Diagram/

Block Diagram
Wire Connection Diagram
bl5934
The connection diagram of FX-8200 is shown below.
TO ALTERA
PCB-7798
TRAY UP
TRAY UP SENS
3-1
Chapter 3 Wire Connection Diagram/Block Diagram Block Diagram
Block Diagram
bl5935
The block diagram of FX-8200 is shown below.

Cable between
power source and
CPU board LCD (7inch WVGA)
CPU BOARD (PCB-7785)
LED Backlight
FPGA LED Backlight Power
Primary
Power Circuit Touch Panel
AC100~240V
Power Secondary (Power Sequence)
Source LCD Signal (RGB24bit) (7-inch 4-wire)
50/60Hz Power Circuit
To respective CLK
NiMH internal power
AC Inlet Cable Battery
Charge Circuit Touch Panel
I/F Circuit
FPGA
Isolation
CLK
Main Pulse LAN port
Bus LAN I/F
Flash ROM
Transceiver Trans x1
NOR
128MB
Isolator Flash
C OP AMP RTouch USB I/F USB USB port
N ADC Transceiver HUB x3
CPU
i_MX
(800MHz)
BUZZER
Key Panel
LED
DDR2 Touch Panel I/F
Circuit ・AC Operation
128MB
䞉 Charge Operation
SDRAM
DDR2 Bus 䞉 Charge Error
128MB
Recorder Sensor C
ASSY
N Key Switch
RECORDER UNIT Recorder I/F Circuit
Mark Sensor C
THERMAL (110mm 8dot/mm) Board N Thermal I/F
(PCB-7798) Circuit
Lithium Battery
STEPPING Paper Tray Up
MOTOR
Sensor Board RTC
(PCB-6862) Motor Sensor I/F
Driver Driver KEY SHEET
CAUTION
 To repair a connector or cable, replace the entire board or contact your local Fukuda Denshi
factory for service. Parts may be damaged when repairing/detaching connectors on the
board as they are very small and pin-pith is very narrow. Repair or removal of the connector
may damage the board, connectors and parts.
 Please handle the flexible cables carefully. Touching the soldered side of the flexible cable
or reversing the soldered side of the flexible cable may result in failure to operate properly
or cause irreparable malfunction.
3-2
Chapter 3 Wire Connection Diagram/Block Diagram Pin Arrangement of External Connector
Pin Arrangement of External Connector

bl5936
CN8 LAN
Model: SS-640810-A-NF-A111
Pin No. Signal Name Remarks
1 TXD+ 10 BASE-T transmission differential data + (output)
2 TXD- 10 BASE-T transmission differential data - (output)
3 RXD+ 10 BASE-T received differential data + (output)

4 NC
5 NC
6 RXD- 10 BASE-T received differential data - (output)
7 NC
8 NC
CN9 USB
Model: XM7A-0442
1 VBus Power supply (+5 V)

2 -DATA Differential data - (I/O)
3 +DATA Differential data + (I/O)
4 GND Ground (DG)
CN10 USB
Model: XM7A-0442-A
1 VBus_1 Power supply (+5 V)
2 -DATA_1 Differential data - (I/O)

3 +DATA_1 Differential data + (I/O)
4 GND_1 Ground (DG)
5 VBus_2 Power supply (+5 V)
6 -DATA_2 Differential data - (I/O)
7 +DATA_2 Differential data + (I/O)
8 GND_2 Ground (DG)
9 SHIELD
10 SHIELD
11 SHIELD
12 SHIELD
3-3
Chapter 3 Wire Connection Diagram/Block Diagram Pin Arrangement of External Connector
CN12 Serial
Model: DF13C-4P-1.25V(51)
1 RXD Received data (input)
2 TXD Transmitt data (output)
3 5V
4 GND Ground (DG)
CN15 ECG
Model: RDAG1-15SE1
1 C2 Chest C2
2 C3 Chest C3
3 C4 Chest C4
4 C5 Chest C5
5 C6 Chest C6
6 RE
7 NC
8 NC
9 R Right arm
10 L Left arm
11 F Left leg
12 C1 Chest C1
13 NC
14 RF Right leg
15 NC
3-4
Chapter 4 Spare Parts List Contents
4-1
Chapter 4 Spare Parts List Contents

bl6682
The following is the spare parts list.

Parts Number Item Name Model Type, Standard, Remarks Q'ty
1E010886* LCD Touch Panel RFF70ZG-AIW-DNS 1
1T010131* Power Supply Unit SNP-GK65-MG 1
1Y001203* Motor PFC25-24Q1G (1/50) -02 1
1W003030* Thermal Print Head AE108-8E701 1
9F011090* CPU BOARD PCB-7785 ASSY 1

6C015713* Key Sheet FM-AP08-165A-B 1
9D011114* Photo Sensor OM-FK01 2
1U000202* Backup Battery CR1220 1
1M010970* Harness AC Inlet Cable 1
1M010971* Harness Cable between power supply and CPU board 1
9E013186* Harness Mark Sensor/Paper Tray Up Sensor Cable 1
5H011734* Upper Case SU (Export) 1
6C015676* Power Supply Plate 1
6C015732* LCD Support 1

6C015733* ECG Shield Cover 1
6C015734* LCD Lid (162 mm) 2
6C015735* LCD Lid (100 mm) 2

6C015677* LCD Support Plate 1
6C015678* Recorder Shield Plate 1
6C015737* Potential Equalization Terminal Cover 1

1K001800* Potential Equalization Terminal POAG-S6/15 1
6C015761* Shielding Gaskets STGPF2-10 (8 mm) 1
1Z010527* Core HF70SH41X08X12 1

9H011499* Lower Case SU 1
6C015714* Recorder Sheet 1
6C015715* Paper Sheet 1
6C003519* Rubber Foot 4
6C015716* Battery Cover 1
1Z010078* Screw Retaining Washer TM-147-1 3
6C012392* Cushioning Material (32 x 65) 1

9E013128* Recorder ASSY
9H011500* Recorder Base SU 1
9H011501* Platen Roller Guide Plate SU 1
6C015686* Adjustable Screw 2
6C015687* Thermal Print Head Fixed Color 1
6C015688* Spring B for Thermal Print Head 1
6C015689* Thermal Print Head Fixing Shaft 1
9H011502* Thermal Print Head Fixing Plate SU 1
6C015691* Lock Plate 1
4-1
Parts Number Item Name Model Type, Standard, Remarks Q'ty

6C015692* Gear A 1
1Z010341* One-way Clutch OWC307GXLZ 1
6C015693* Static-Eliminator Felt 1
6C015694* Paper Tray 1
9H011503* Push Button SU 1
6C015696* Spring for Buttons 1
6C015697* Shaft for Hook Attachment 1
9H011504* Paper Support SU 1

6C015699* Hook 2
6C015700* Platen Roll 1
6C015773* Bearing DDL-1150ZZRP0P25LY551 2
6C015702* Gear B 1
9H011505* Paper Case SU 1
9H011506* Hook Holder (A) SU 1
6C015706* Hook Holder (B) 1
6C015707* Paper Guide 1
6C015708* Paper Tray Attachment Shaft 1

6C015709* Paper Cutter 1
6C015710* Motor Mounting Bracket 1
6C015711* Soft Gasket UC-300284 V-O (15mm) 1

6C015760* Shielding Gaskets STGPF8-8 (10 mm) 1
5T010029* Polystyrene Washer STW-FT60-0.25 2
5T010028* Polystyrene Washer STW-FT30-0.25 1

6C015722* Brass Spacer BSB-2607 2
5T007004* E Ring 2.0 1
5T007005* E Ring 2.5 1
5T007006* E Ring 3.0 4
5T007007* E Ring 4.0 2
5H010854* Caution Mark Label 1
Follow Operating Instructions Mark

5H011018* 1
Label
5H011739* Caution Label (Battery) 1
The current revision will be shown in the digit indicated by “*”
4-2
Chapter 5 Disassembly and Assembly Procedure Contents
Chapter 5 Disassembly and Assembly

Procedure
Power Supply Block..................................................................... 5-1

Paper Tray Block ......................................................................... 5-2
Recorder Block (1/3).................................................................... 5-3
Recorder Block (2/3).................................................................... 5-4
Recorder Block (3/3).................................................................... 5-5
Upper Case Block (1/2) ............................................................... 5-6
Upper Case Block (2/2) ............................................................... 5-7
Lower Case Block........................................................................ 5-8
General Assembly Diagram......................................................... 5-9
External Appearance ................................................................. 5-10
Removing the Lower Case ........................................................ 5-11
Removing the Recorder Block ................................................... 5-11
Removing the CPU Board ......................................................... 5-12
Removing the Power Supply Unit .............................................. 5-14
Removing the LCD .................................................................... 5-14
5-1
Chapter 5 Disassembly and Assembly Procedure Contents
Chapter 5 Disassembly and Assembly Procedure Power Supply Block
Chapter 5 Disassembly and Assembly

Procedure
Power Supply Block
bl6735
2-Double washer sems M3 x 8
2-M6 Nut
6 Potential Equalization Terminal Cover 1
5 Grounding Plug POAG-S6-15 1 Common with FX-8222
4 Cable between power supply and CPU board 1
3 AC Inlet Cable 1
2 Power Supply Unit SNP-GK65-MG 1
1 Power Supply Plate 1
No. Item/Model Type Q'ty Remarks
5-1
Chapter 5 Disassembly and Assembly Procedure Paper Tray Block
Paper Tray Block

bl6736
2-E-type retaining rings

Nominal diameter 3

Nominal diameter 4
9 Paper Support SU 1
8 Platen Roll 1
7 Gear B 1
6 DDL-1150ZZRP0P25LY551 2
5 Shaft for Hook Attachment 1
4 Spring for Buttons 1
3 Push Button SU 1
2 Hook 2
1 Paper Tray 1
5-2
Chapter 5 Disassembly and Assembly Procedure Recorder Block (1/3)
Recorder Block (1/3)

bl6738
2-Double washer sems M2.6 x 5

Glass cloth adhesive tape_No.188UL_Width 10mm x Length 55mm
E-type retaining ring

Nominal designation 2
E-type retaining ring

Nominal designation 2.5

After tightening the screw,
secure it with screw lock glue.
After tightening the screw,
secure it with screw lock glue.
17 Thermal Print Head AE108-8E701 1
16 Static-Eliminator Felt 1
15 STW-FT Nominal Diameter 6x0.25 2
14 STW-FT Nominal Diameter 3x0.25 1
13 One-way Clutch OWC307GXLZ 1

12 PFC25-24Q1G (1/50) -02 1
11 Motor Mounting Bracket 1
10 Gear A 1
9 Soft Gasket UC-300284 V-O (15mm) 1
8 Thermal Print Head Fixing Plate SU 1
7 Lock Plate 1
6 Adjustable Screw 2
5 Thermal Print Head Fixed Color 1
4 Thermal Print Head Fixing Shaft 1
3 Spring B for Thermal Print Head 1
2 Platen Roller Guide Plate SU 1
1 Recorder Base SU 1
5-3

bl6739
6 BSB-2607 Brass Spacer (Hexagon) 2
5 Hook Holder (B) 1

4 Hook Holder (A) SU 1
3 Mark Sensor/Paper Tray Up Sensor Cable ASSY 1
2 Paper Guide 1
1 Paper Case SU 1
5-4

bl6740
Tool: Phillips Screwdriver #2

2-Flat head screws M3 x 6
Double washer sems M2.6 x 5
Double washer sems M2.6 x 5

Nominal designation 3
5 Paper Cutter 1
4 Paper Tray Attachment Shaft 1
3 Recorder Block (2/3) 1

1 Paper Tray Block 1
5-5
Chapter 5 Disassembly and Assembly Procedure Upper Case Block (1/2)
Upper Case Block (1/2)

bl6741
P-type Nominal designation 3 x 10
P-type Nominal designation 3 x 10
4-P-type Nominal designation 3 x 10
10 Core HF70SH41X08X12 1
9 Shielding Gaskets STGPF2-10 (8 mm) 1
8 LCD Lid (100 mm) 2

7 LCD Lid (162 mm) 2
6 LCD Support Plate 1
5 LCD Support 1
4 RFF70ZG-AIW-DNS 1
3 Power Supply Block 1
2 FM-AP08-165A-B 1
1 Upper Case SU (Export) 1
5-6
Chapter 5 Disassembly and Assembly Procedure Upper Case Block (2/2)
Upper Case Block (2/2)

bl6742
Double washer sems M3 x 8
6 Shielding Gaskets STGPF8-8 (10 mm) 1
5 ECG Shield Cover 1
4 PCB-7785 ASSY 1
3 Recorder Shield Plate 1

1 Upper Case Block (1/2) 1
5-7
Chapter 5 Disassembly and Assembly Procedure Lower Case Block
Lower Case Block

bl6744
7 Screw Retaining Washer TM-147-1 2
6 Rubber Foot 4
5 Cushioning Material (32 x 65) 1
4 Battery Cover 1
3 Recorder Sheet 1
2 Paper Sheet 1
1 Lower Case SU 1
5-8
Chapter 5 Disassembly and Assembly Procedure General Assembly Diagram
General Assembly Diagram

bl6745
FX-8200 (EXP) Rating Label

6 1
(with number assigned)
5 Follow Operating Instructions Mark Label 1
4 Caution Mark Label 1
3 Caution Label (Battery) 1
2 Lower Case Block 1
1 Upper Case Block (2/2) 1
5-9
Chapter 5 Disassembly and Assembly Procedure External Appearance
External Appearance
bl5947
206 ± 10 mm
260 ± 10 mm
66 ± 10 mm
5-10
Chapter 5 Disassembly and Assembly Procedure Removing the Lower Case
Removing the Lower Case

bl5948
1 Remove five screws (P-tight with washer head, M3x10) on the bottom side of the main unit, and remove the
lower case.
Removing the Recorder Block

bl5950
1 Disconnect the cables connected to the CPU board.

(Thermal Flexible Cable, Motor Cable, Mark Sensor/Paper Tray Up Sensor Cable ASSY)
5-11
Chapter 5 Disassembly and Assembly Procedure Removing the CPU Board
2 Remove four screws (P-tight with washer head, M3x10), and remove the recorder block.
Removing the CPU Board

bl5949
1 Disconnect the flexible cables connected to the CPU board.

(Key Sheet Flexible Cable, LCD Flexible Cable, Touch Panel Flexible Cable)
5-12
Chapter 5 Disassembly and Assembly Procedure Removing the CPU Board
2 Remove five screws (P-tight with washer head, M3x10).
3 Lift up the CPU board to disconnect the cable between power supply and CPU board, and remove the CPU
board.
5-13
Chapter 5 Disassembly and Assembly Procedure Removing the Power Supply Unit
Removing the Power Supply Unit

bl5951
1 Remove one screw (P-tight with washer head, M3x10), and remove the power supply part.
2 Remove two screws (double washer sems M3x8) and remove the power supply unit.
Removing the LCD

bl5953
1 Remove five screws (P-tight with washer head, M3x10), and remove the LCD.
5-14
Chapter 6 Software Update Contents
Software Updating Procedure ..................................................... 6-1
6-1
Chapter 6 Software Update Contents
Chapter 6 Software Update Software Updating Procedure

Software Updating Procedure
bl5954
The software can be updated using the USB memory.
CAUTION
 Never unplug the USB memory while updating the software. It may cause a malfunction of
the main unit or USB memory, or software update may not be possible.
 When updating the software, make sure to operate with AC power supply.
1 Insert the USB memory containing the software update program into USB memory slot 1.
2 Turn ON the power while pressing the [ ] (LEAD) key on the operation panel.
3 The installation screen will be displayed. When the message "Installation complete" is displayed, disconnect
the USB memory and turn off the power.
6-1
Chapter 6 Software Update Software Updating Procedure
6-2
Chapter 7 Troubleshooting Contents
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
Trouble at Startup...........................................................................7-4
Trouble during Operation................................................................7-5
7-1
Chapter 7 Troubleshooting Contents
Chapter 7 Troubleshooting When Malfunction Occurs
When Malfunction Occurs
When the ECG Waveform is Unstable

bl5955
When the ECG waveform is unstable, check the following items.
Is the place of examination appropriate?

 Is there noise generating electrical devices such as x-ray devices or ultrasound devices nearby? If there is, turn
OFF the power of those devices or select another place for examination.
 Is the temperature of the place of examination kept within 20°C to 25°C (68°F to 77°F) range?
 Is the humidity of the place of examination low?
Is the patient cable connected properly?

 Is it securely locked?
 Is the lead cable securely connected to the electrode?
Is the electrode status good?

 Is the electrode attaching area of the patient's skin thoroughly wiped with alcohol swab, and cleaned with a skin
cleaner?
 Are the electrodes within expiration date and electrode gel not dried? If expired or dried, use new electrodes.
 Are proper electrodes used? New and old electrodes or different types of electrodes should not be mixed up.
 Are the electrodes attached to the correct positions?
NOTE
 If the electrode attachment is loose, or if the cable is pulled, noise may interfere to the ECG
waveform.
When the Equipment does not Operate

bl5956
When the FX-8200 does not operate, check the following items.
Is the AC power properly supplied?

 Is the commercial 100/240 V AC power supplied?
 Is the power supply cable securely connected to the equipment?
 Is the power supply cable securely connected to the outlet?
Is any external equipment interfering?

 Is the power of the external equipment turned ON?
 Is specified cable used for connecting the external equipment?
 Is there any breakage on the cable connecting the external equipment?
7-1
Chapter 7 Troubleshooting Messages and Remedies
NOTE
 Except for the case when the trouble is caused by the external equipment, it is
recommended to disconnect the external equipment for smooth troubleshooting.
Messages and Remedies

bl5957
FX-8200 displays various messages during operation, and prompts the operator for confirmation
See [FX-8200 Operation Manual] for details of each message.
Here, the causes and countermeasures of the important messages are given.
Battery
bl5664
Message Cause Solution

<Replace the backup battery. The The backup battery for the clock is running out. The backup battery needs to be replaced. For
clock will be initialized. details, refer to "Maintenance" .
(Contact your dealer for details.)>
<To not run out of battery, the power During battery-powered operation, the power Turn the power OFF and then turn it back ON.
supply will be switched off will automatically turn OFF if the operation is
automatically.> not performed within the specified duration.
<Battery is running low. Please During battery operation, the power will Connect the power cable to switch to AC
recharge the battery.> automatically turn OFF when the battery power operation, or charge the battery.
capacity becomes low.
<Cannot record due to low battery The printing could not be started due to low Connect the power cable to switch to AC
voltage.> battery level. power operation, or charge the battery.
<The battery voltage is too low. The printing has been canceled due to low Connect the power cable to switch to AC
Printing has been canceled.> battery level. power operation, or charge the battery.
<The battery voltage is too low. The equipment could not access the media Connect the power cable to switch to AC
Cannot access Media.> due to low battery level. power operation, or charge the battery.
<Battery is running low. Please The battery installed in the equipment is Recharge the battery before operating the
recharge the battery.> running low. equipment on battery power.
7-2
Chapter 7 Troubleshooting Hardware Trouble
File
bl5667
Message Cause Solution
<Failed to format (Media).> Formatting of the media has failed. The failure of the media can be considered.
Contact your local Fukuda Denshi service
representative.
<There is not enough space on There is not enough space on the media to Replace with a media with enough capacity.
(media). Please replace the media save the data.
with another one.>
<Cannot write due to insufficient The data could not be saved on the media as When this message is displayed, the data is
space on (media).> the maximum number of recordable data has not saved.Insert a new media and save the
been reached. data again.
<Cannot store data.> Failed to save the data to the media. The failure of the media can be considered.
Write down the error code at the end of the
message and contact your local Fukuda
Denshi service representative.
<Please set (media).> The media is not set. Set the media.
<Failed to read from the file.> Failed to read the data from the file. The failure of the media can be considered.
Write down the error code at the end of the
message and contact your local Fukuda
Denshi service representative.
<The examination data was not The examination data was not saved when Save the examination data before proceeding
saved.> proceeding to the next examination. to the next examination.
<Failed to delete data.> Failed to delete ECG data. The failure of the media can be considered.
representative.
<No data selected.> A process was performed without selecting Select data before performing the process.
data.
<Failed to save the settings.> Failed to save the settings to the media. The failure of the media can be considered.
representative.
<Failed to load settings.> Failed to load the settings from the media. Make sure to use the correct media to which
settings are saved.
If failure occurs even though the correct media
is used, it may be defective. Contact your local
Fukuda Denshi service representative.
Hardware Trouble
bl5958
DANGER
 While operating the equipment, do not unplug the AC power cable or remove the battery. To
cease the operation, use the power supply switch.
It may cause irreparable damage to the system file.
CAUTION
 When replacing parts, it is recommended to replace in board unit. The electric parts soldered
on to the board are very small surface-mounted components, and may damage the board
or other parts when replacing.
 If the power cannot be turned OFF using the power ON/OFF key, press down the key for
about 10 seconds to turn OFF the power forcibly.
 Always remove the batteries before checking the board and connectors. Otherwise, it may
cause damage to the equipment.
7-3
 Do not insert or remove cables with wet hands.This may cause electric shocks, short
circuiting or injury.
NOTE
 The "Possible Cause" listed on the following pages are not necessarily the actual causes.
 Various malfunctions may be combined. After repairing, make sure to perform safety check
and operation check.
Trouble at Startup
bl5959
Symptom Possible Cause Malfunctioning Part Solution
AC power supply LED AC power is not supplied. Power Supply Cable Replace the power supply cable.
does not light.
AC power supply LED is Key Sheet Replace the key sheet (6C0156790).
damaged.
Cable disconnection AC Inlet Cable (3P) Replace the cable (1M0109700).
Cable between power Replace the cable (1M0109710).

supply and CPU board
(5P)
Power fuse is blown. Power Fuse Replace the fuse.
Power supply failure Power Supply Unit Replace the power supply unit
(1T0108860).
The system does not +18V power is not supplied. Key Sheet Replace the key sheet (6C0156790).
activate with AC power
supply. (AC power supply Power ON circuit is not Key Sheet Replace the key sheet (6C0156790).
LED is lighted.) functioning.
Power ON signal is not PCB-7785 Replace the PCB-7785
transmitted to CPU. (9F0110900).
The system does not Battery Capacity Shortage Battery Capacity Charge the battery.
activate with a battery. Replace the battery (1U000337D).
Disconnection of Battery Cable Battery Replace the battery (1U000337D).
+18V power is not supplied. Key Sheet Replace the key sheet (6C0156790).
Power ON circuit is not Key Sheet Replace the key sheet (6C0156790).
functioning.
Power ON signal is not PCB-7785 Replace the PCB-7785

transmitted to CPU. (9F0110900).
The system freezes on Failure of the device on the CPU DDR-SDRAM Replace the PCB-7785
the logo display. board (9F0110900).
CPU Replace the PCB-7785

(9F0110900).
Charging does not start. Loose connection or Battery Replace the battery (1U000337D).
disconnection of cable
Charge error LED lights. Battery other than specified is Battery Replace the battery (1U000337D).
used.
Battery Failure Battery Replace the battery (1U000337D).
The operation time is Battery Deterioration Battery Replace the battery (1U000337D).
short although the battery
is charged.
7-4
Trouble during Operation

bl5960
ECG Data
The ECG waveform is in ECG Data Receiving Circuit PCB-7785 Replace the PCB-7785
the baseline position. (All Failure (9F0110900).
leads)
ECG Amp Power Failure ECG Amp Power Supply Replace the PCB-7785
Circuit (9F0110900).
The ECG waveform is not Disconnection of Lead Cable Lead Cable Replace the lead cable
displayed. (Specific lead) (9D011664C).
ECG Amp Failure ECG Amp Circuit Replace the PCB-7785

(9F0110900).
Failure of the AD converter circuit AD Converter Circuit Replace the PCB-7785

for the corresponding lead (9F0110900).
Noise is interfering to the Disconnection of lead cable Lead cable Replace the lead cable
ECG waveform. (All shielded wire (9D011664C).
leads)
Failure of the Right Leg Drive ECG Amp Circuit Replace the PCB-7785
Circuit (9F0110900).
Failure of Lead OFF Circuit ECG Amp Circuit Replace the PCB-7785
(9F0110900).
Noise is interfering to the Disconnection of lead cable Lead cable Replace the lead cable
ECG waveform. (Specific shielded wire (9D011664C).
lead)
(9F0110900).
AD Converter Circuit Failure AD Converter Circuit Replace the PCB-7785
(9F0110900).
Lead OFF is detected. Disconnection of Lead Cable Lead cable Replace the lead cable
(Lead OFF is not (9D011664C).
detected.)
(9F0110900).

(9F0110900).
AD Converter Failure AD Converter Replace the PCB-7785

(9F0110900).
ECG Data Receiving Circuit PCB-7785 Replace the PCB-7785

Failure (9F0110900).
LCD
Nothing is displayed on Backlight power is not supplied. LCD Replace the LCD.
the LCD.
LCD power is not supplied. LCD Replace the LCD.
LCD Failure LCD Replace the LCD.
LCD scintillates. Loose connection or LCD Replace the LCD.

disconnection of cable
LCD is hard to see. LCD brightness is too dark. None Increase the LCD brightness.
LCD cable is not securely LCD Connect the cable securely.

connected.
7-5
Printing
Printing is not performed. Cable Disconnection Thermal Cable (28P) Replace the thermal print head
(1W003030A).
FPGA Failure FPGA Replace the PCB-7785

(9F0110900).
Thermal Print Head Failure Thermal Print Head Replace the thermal print head
(1W003030A).
Paper Feeding Error Cable Disconnection Motor Replace the motor (1Y0008550).
Paper Tray Up Sensor Failure Paper Tray Up Sensor Replace the sensor ASSY
(9E0131860).
FPGA Failure FPGA Replace the PCB-7785

(9F0110900).
Motor Failure Motor Replace the motor (1Y0008550).
Z-fold paper does not stop Cable Disconnection Sensor ASSY Replace the sensor ASSY
at the perforation. (9E0131860).
Mark sensor part is unclean. Mark sensor Clean the mark sensor.
Sensor Signal Detection Circuit Recorder Board Replace the PCB-7785

Noise is interfering to the Disconnection of lead cable Lead Cable Replace the lead cable
ECG waveform. (Specific shielded wire (9D011664C).
lead)
(9F0110900).
AD Converter Circuit Failure AD Converter Circuit Replace the PCB-7785
(9F0110900).
Lead OFF is detected. Disconnection of Lead Cable Lead Cable Replace the lead cable
(Lead OFF is not (9D011664C).
detected.)
(9F0110900).

(9F0110900).
AD Converter Failure AD Converter Replace the PCB-7785

(9F0110900).
ECG Data Receiving Circuit PCB-7785 Replace the PCB-7785
Operation Panel
The key does not function Cable Disconnection Key Sheet Replace the key sheet.
properly.
Key Contact Point Failure Key Sheet Replace the key sheet.
Key CPU Failure PCB-7785 Replace the PCB-7785

(9F0110900).
LED does not light for the LED Failure Key Sheet Replace the key sheet.
pressed key.
7-6
Other
Buzzer tone is difficult to Buzzer Failure Buzzer Replace the PCB-7785

recognize. (or is not (9F0110900).
generated.)
Buzzer Circuit Failure Buzzer Circuit Replace the PCB-7785
(9F0110900).
Clock, calendar is not The backup battery is depleted. Backup Battery Replace the backup battery
correct. (1U0002210).
Refer to "Backup Battery
Replacement12".
RTC (IC) Failure RTC Replace the PCB-7785

(9F0110900).
Fuse is blown. Circuit Failure PCB-7785 Replace the PCB-7785
(9F0110900).
Fuse Failure Fuse Replace the power supply unit

(1T010131A).
Power does not turn OFF. Power OFF Circuit Failure Key Sheet Replace the key sheet.
Freeze-up of Software None Press down the power supply switch

for 10 seconds to force-quit the
system.
7-7
7-8
Chapter 8 Maintenance Contents
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................................................................................8-4
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 ...........................................................8-9
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
8-1
Chapter 8 Maintenance Contents
Chapter 8 Maintenance Self-Diagnosis (User Maintenance)
Self-Diagnosis (User Maintenance)
bl5961
There are following items on the user maintenance menu.

Simulator Waveform Set Date/Time Display Status
General Test 1 General Test 2 Key Test
Sound Test LCD test Thermal Printing Test
Touch Panel Test I/O Test Adjust LCD Brightness
User Maintenance Menu

bl5962
1 Touch the [Menu], [Maintenance] keys.
2 On the maintenance menu, select an item.
3 Touch [Back] to return to the menu display.
Test Pattern Waveform

bl5963
Select an ECG test pattern waveform to be used for operation check and demonstration.
1 Select [Simulator Waveform] on the "Maintenance" menu.The screen to select the test pattern waveform will
be displayed.
8-1
2 The test pattern can be selected from the following 5 patterns.
Pattern Description
Pattern 1 Normal Waveform
Pattern 2 Myocardial Infarction
Pattern 3 Extrasystole
Pattern 4 Brugada Type
Pattern 5 Brugada Risk
3 Touch [Back] > [Back] > [To exam] to return to the examination screen.
The test pattern information will not be backed up. When the power is turned ON, or when the setting is
initialized, the test pattern will not be output.
Date/Time
bl5964
Set the date/time.
1 Select [Set Date/Time] on the "Maintenance" menu.
2 Touch [Set Date/Time].
8-2
3 Set the year, month, day, time, and touch [ ].
Status Display
bl5965
Battery status, etc. can be checked.
1 Select [Status Display] on the "Maintenance" menu.
The status screen will be displayed.
8-3
General Test 1
bl5966
Test the LCD, touch panel, key/LED, sound, and status.
1 Select [General Test 1] on the "Maintenance" menu.
The "General Test 1" screen will be displayed.
2 Press the (Start/Stop) key on the operation panel.
On the touch panel test screen, touch the cross-shaped marks and check that the marks change to circle.
The screen will switch each time the mark is touched. Check that there are no missing dots or uneven colors
in each screen.
3 Press the operation panel key and check that the corresponding key displayed on the screen is highlighted.
To end the key test, touch [Next].
4 Touch the buzzer mark, and check that the corresponding sound is generated.
8-4
To end the sound test, touch [Next].
5 On the status screen, check each status.
General Test 2
bl5967
Test the recording, memory, external I/O.
1 Select [General Test 2] on the "Maintenance" menu.
The "General Test 2" screen will be displayed.
2 Prepare test cables, USB memory, LAN, recording paper, and press the (Start/Stop) key on the
operation panel.
The test will start, and "OK" or "NG" will be displayed for each test item.
If the judgement is "OK" for all test items, "OK" will be displayed for "General".
8-5
If the judgement is "NG" for any of the test items, "NG" will be displayed for "General".
Key Test
bl5968
Test the key operation.
1 Select [Key Test] on the "Maintenance" menu.
The key test screen will be displayed.
2 Press the operation panel key and check that the corresponding key displayed on the screen is highlighted.
Sound Test
bl5969
Test the sound operation.
1 Select [Sound Test] on the "Maintenance" menu.
The sound test screen will be displayed.
2 Touch the buzzer mark, and check that the corresponding sound is generated.
8-6
Screen Test
bl5970
Test the display.
1 Select "Display Test" from Maintenance Menu Screen.
When selected, the screen switches in the order red -> green -> blue -> ash.
Make sure there are no missing dots or color unevenness.
2 You can return to the test screen by [Return] -> [to Test]
Touch Panel Test

bl5971
Test the touch panel operation.
1 Select [Touch Panel Test] on the "Maintenance" menu.
The screen to test the touch panel will be displayed.
2 Touch the cross-shaped marks and check that the marks change to circle.
3 Touch [End] > [Back] > [To exam] to return to the examination screen.
Thermal Printing Test

bl5972
Test the thermal printing operation.
1 Select [Thermal Printing Test] on the "Maintenance" menu.
The screen to test the thermal printing will be displayed.
8-7
2 Selecting the printing speed and pattern will start the printing.
3 Check the printing speed, and check that there are no phase shift, missing dots, or uneven colors.
I/O Test
bl5973
Test the I/O operation.
1 Select [I/O Test] on the "Maintenance" menu.
"I/O Test" menu will be displayed.
3
5
2 Connect the LAN cable to the LAN connector and connect to the PC using a HUB.
When "IP address" window is displayed by touching [LAN], enter the IP address of the electrocardiograph.
3 Touch [LAN] to start the test, and check that "OK" is displayed.
4 Set the USB memory to all the USB ports.
5 Touch [USB1], [USB2], [USB3] to start the test, and check that "OK" is displayed.
8-8
Chapter 8 Maintenance Self-Diagnosis (Manufacturer Maintenance)
LCD Brightness Adjustment

bl5974
Adjust the LCD brightness.
1 Select [Adjust LCD Brightness] on the "Maintenance" menu.
The screen to adjust the LCD brightness will be displayed.
2 Touch the arrows to adjust the brightness.
The minimum brightness is 0, maximum brightness is 5. Adjust to the appropriate brightness.
Self-Diagnosis (Manufacturer Maintenance)

bl5975
There are following five items on the manufacturer maintenance menu.

AMP Status Adjust perforations MAC Address
Adjust touch panel Screen Capture
Manufacturer Maintenance Menu

bl5976
1 Touch the [Menu], [Maintenance] keys.
2 Touch [Manufacturer Maintenance], and enter the password.
Enter the password, "9001" on the following window.
8-9
3 On the manufacturer maintenance menu, select an item.
AMP Status
bl5977
Check the AMP status.

On the manufacturer maintenance menu, select [AMP Status].
Adjust Perforations
bl5978
Adjust the recording paper perforation position.

On the manufacturer maintenance menu, select [Adjust perforations].
Touch the right and left arrows to adjust the perforation position.
8-10
MAC Address
bl5979
Touch [MAC Address] to open the "MAC Address" screen. This setting is not necessary as it is factory-configured.
Adjust Touch Panel

bl5980
Touch the center part of "+" displayed on the screen.
Screen Capture
bl5981
The hard copy function can be enabled/disabled.When enabled, the displayed screen can be saved on the USB
memory in png format by pressing the (RESET) key on the operation panel.
8-11
Chapter 8 Maintenance Backup Battery Replacement
Backup Battery Replacement

bl5982
The backup battery can be replaced by removing the lower case. After the replacement, make sure that "OK" is
displayed on the status display area of the maintenance menu.
1 Remove the lower case block.
Refer to the assembly diagram (

"General Assembly Diagram" P5-9).
2 Remove the lithium battery located at the position shown in the following picture.
3 As shown in the following picture, hold one side and hook the edge with a finger to remove it.
8-12
Chapter 8 Maintenance Main Battery (8PH-4/3A3700-H-J18) Replacement
4 As shown in the following picture, insert one side of the new lithium-ion battery and push it in with finger.
5 After the replacement, make sure that "OK" is displayed on the status display area of the maintenance menu.
(
"Status Display" P8-3)
Main Battery (8PH-4/3A3700-H-J18) Replacement

bl5983
When replacing the main battery, follow the precautions below.
WARNING
 Make sure to disconnect the power cable before mounting or replacing the battery.
Otherwise, it may result in electric shock.
 Do not throw the battery into fire. If the battery is placed in fire, it may explode.
 Charge the battery only with this equipment. Otherwise, acid leakage, overheating or
explosion may occur.
 Do not disassemble or remodel the battery. If the battery breaks and the acid leaks onto the
skin or clothing, wash it off with water immediately. If the acid gets into the eyes, rinse with
clean water and consult a doctor immediately.
 Do not use the battery with any other equipment. Otherwise, acid leakage, overheating or
explosion may occur.
 Do not short-circuit the terminal. Otherwise, acid leakage, overheating or explosion may
occur.
 If charging is not completed after the prescribed charging time, stop charging the battery.
Otherwise, acid leakage, overheating or explosion may occur.
 Do not drop the battery or subject it to strong impact.
 When disposing of a battery, entrust disposal to a specialized waste disposal contractor.
CAUTION
 Make sure to use the specified battery (8PH-4/3A3700-H-J18). Acid leakage, overheating or
explosion may occur if a battery other than the specified battery is used.
8-13
Chapter 8 Maintenance Main Battery (8PH-4/3A3700-H-J18) Replacement
NOTE
 The date of manufacture is indicated on a label of the main battery.
Procedure to Replace the Main Battery

1 Remove the 2 screws on the bottom of the battery cover, and then remove the battery cover.
2 Take out the battery from the main unit, and disconnect the battery connector from the main unit.
3 Connect the new battery connector to the main unit, and then insert the new battery into the main unit.
4 Place the battery cover back in its original position and tighten the screws.
NOTE
 Pay attention to the connector orientation.
 Place the convex side of the battery facing down.
 Make sure to disconnect the power cable before replacing the battery.
8-14
Chapter 8 Maintenance Replacement of Display Unit Backlight
 Be careful not to pinch the connection cable under the cover.
Precautions for Usage of Battery

Take the following precautions when using the battery.
Battery Life
The battery can be charged and discharged (used) for approximately 500 times. Note that the service life varies
depending on the frequency of use and the charging/discharging pattern of the battery. If the battery runs out shortly
after being charged, this means that it has reached the end of its life and needs to be replaced with a new battery.
Storing the Battery
If not using the equipment for a long time, remove the battery from the equipment and store it. Every three months,
install the battery in the equipment and fully charge it. If left for a long period of time, the battery may self-discharge
to the point where it can no longer be used.
Avoid storing the battery in a place where the temperature is lower than 0°C or higher than 35°C.
Replacement of Display Unit Backlight

bl5984
The display unit backlight is a component of LCD module. After the replacement, adjust the touch panel.
1 Remove the lower case block.
Refer to the assembly diagram (

2 Remove the upper case.
Refer to Upper Case Block 1 (

Block (2/2)" P5-7).
"Upper Case Block (1/2)" P5-6), Upper Case Block 2 ("Upper Case
3 Replace the display unit backlight, and reattach the lower case and upper case.
4 Touch [Manufacturer Maintenance] on the maitenance menu, and enter "9001".
8-15
Chapter 8 Maintenance Motor Replacement
5 Touch [Touch Panel Adjust] to switch to the next screen.
6 Touch the center part of "+" displayed on the screen.
When the next pointer is displayed, touch the pointer.

When all five (5) points are touched, the touch panel adjustment will automatically end.
Motor Replacement
bl5985
When replacing the motor, it is necessary to remove the recorder block. After the replacement, make sure to adjust
the meshing of gear.
Tool: Phillips Screwdriver #2, E Ring Plier
1 Remove the recorder block.
Refer to "General Assembly Diagram" (

2 Remove the motor.
Remove the motor from the recorder block.
Remove the E ring, gear, washer from the motor.
3 Adjust the meshing of gear.
8-16
Chapter 8 Maintenance Thermal Print Head Replacement
Tighten the screw while verifying the gear contact.
Thermal Print Head Replacement

bl5986
When replacing the thermal print head, it is necessary to remove the recorder block.After the replacement, make sure
to adjust the thermal recorder.
Tools: Phillips Screwdriver #2, 5.5 mm Nut Driver
1 Remove the recorder block.
Refer to "General Assembly Diagram" (

2 Remove the thermal print head.
Refer to the following section.

"Recorder Block 1" (
"Recorder Block (1/3)" P5-3)
"Recorder Block (3/3)" P5-5)
"Recorder Block (2/3)" P5-4)

3 Adjust the thermal recorder.
Refer to "Adjusting the Thermal Recorder" (

"Adjusting the Thermal Recorder" P8-17).
Adjusting the Thermal Recorder

bl5987
Adjust the contact between the print head and recording paper of the thermal recorder.After replacing the motor and
thermal print head, make sure to adjust the thermal recorder.
Tools: Cross Slot Screwdriver #2, 5.5 mm Nut Driver
1 Remove the recorder block from the upper case of the main unit.
2 On the "Maintenance" menu, select "Thermal Printing Test".
3 Loosen the screws indicated with square marks.
8-17
Chapter 8 Maintenance Adjusting the Thermal Recorder
4 Loosen the screws indicated with circle marks using a 5.5 mm nut driver, and adjust the thermal print head.
5 On the "Thermal Printing Test" menu, select the printing pattern and speed for test printing.
1 Touch [Print Head Test] to test the print density.

2 Touch [Rectangular Pattern], and verify that the rising line is not faded, and the phase shift is within 0.5 mm.
6 Tighten the screws loosened in step 3, 4.
7 Touch [Rectangular Pattern], and verify that the phase shift is within 0.5 mm.
If the phase shift exceeds 0.5 mm, repeat steps 3 to 6.
8-18
Chapter 8 Maintenance Cleaning and Disinfecting
Cleaning and Disinfecting
Cleaning the Equipment

bl5876
Cleaning housing
Clean the housing using a tightly squeezed gauze or an absorbent cotton cloth moistened with neutral detergent or
ethanol for disinfection.
CAUTION
 Clean the equipment frequently so that stains can be removed easily.
 To prevent injury, it is recommended to wear gloves when cleaning the equipment.
 Pay attention not to allow chemical solution to enter the equipment or connectors.
 Do not use organic solvents, thinner, toluene or benzene to avoid damaging the resin case.
 When sterilizing the entire room using spray solution, be careful that no chemical gets into
the equipment or adheres to the connectors.
 Use only ethanol for disinfection or neutral detergent to clean the housing. Otherwise, the
surface resin coating may damage, resulting in discoloration, scratches, and other
problems.
Example:
Chemical cloth, scrub brush, abrasive, polishing powder (cleanser, etc.), hot water, volatile
solvent and chemicals (thinner, benzine, benzol, and synthetic detergent for home and
furniture), or sharp-edged tools
Cleaning the Thermal Print Head

Printing paper dust adhering to the thermal print head lowers the print quality. If printed ECG data or characters begin
to fade or become unclear, clean the thermal array head. Use a cotton swab moistened with alcohol to wipe them off.
Remove paper scraps and dust accumulated on the recording paper sensor. Otherwise, recording paper and marks
may not be detected properly.
CAUTION
 Never use sandpaper as it will damage the heating element.
 Contact your Fukuda Denshi representative when the thermal print head requires cleaning.
Cleaning touch panel

Since the display panel uses a touch panel, finger prints and other stains are likely to appear on the touch panel.
Wipe the touch panel using an optional cleaning cloth or eyeglass cleaning cloth.
CAUTION
 Never use strong-acidic cleaning solution.
 A special coating is applied to the surface of the touch panel. Do not wipe the surface with
a cloth or gauze. Wipe the surface with an optional cleaning cloth or commercially available
eyeglass cleaning cloth.
8-19
Chapter 8 Maintenance Cleaning and Disinfecting
Cleaning the Accessories

bl5992
Lead cable and connection cables

Wipe gently with neutral detergent or 70% isopropyl alcohol for cleaning. Do not use organic solvents such as
thinner or toluene.
Clip electrodes
Wipe gently with neutral detergent or alcohol for cleaning. Do not use organic solvents such as thinner or toluene.
8-20
Chapter 9 Maintenance and Inspection Contents
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
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 ................................................. 9-9
Replacement Period of Consumable Parts ....................................9-9
9-1
Chapter 9 Maintenance and Inspection Contents
Chapter 9 Maintenance and Inspection Daily Check

bl5862
To operate this equipment safely for a long time, it is essential to inspect the equipment and replace consumable parts
This chapter describes the maintenance and inspection procedures for this equipment.
Make sure to perform daily checks and periodic checks to maintain functionality, performance and reliability.
Please note that Fukuda Denshi shall not be liable for accidents arising from failure to perform maintenance and
inspections.
WARNING
 Do not disassemble or modify the equipment. Disassembly may cause a fire hazard or
electric shock.
CAUTION
 Do not perform any maintenance procedure which is not described in this manual. Failure
to observe this caution may result in a malfunction.
Daily Check
bl5863
Perform the Daily Check Procedure described below everyday.

 If the equipment fails any check item in the Daily Check List (
Repair the equipment so that it passes all the check items.
P10-2 ), the overall judgment will be "Fail".
 Use the equipment only if the judgments for all the items are "OK".
Daily Check Procedure

bl5864
Appearance
Visually check the following points according to the description of the table below.
Item Inspection Item Procedure Criteria
Main Unit 1) Enclosure Verify that there is no scratch, crack, Should be free of exterior flaws, cracks,
deformation or rust on the main unit. deformation, rust.
2) Label and panel Verify that labels and panels are not peeled No peeling or staining
off or stained.
3) Key Check the key for damage. No damage
Accessories Power cable, Check for scratch and damage. There should be no scratch or damage.
Lead cable
2) Clip electrode, chest Check for dirt, rust, scratch, and damage. Should be free of dirt, rust, scratch or
electrode damage
3) Recording paper Check the condition of loading of the The recording paper should be loaded
recording paper. properly.
4) Operation Manual Verify that the operation manual is kept in It must be kept in specified location.
specified location.
9-1
Chapter 9 Maintenance and Inspection Periodic Check
Mechanical
Check the equipment for mechanical failures while actually operating the equipment.
Main Unit 1) Key Verify that key operation is smooth. Smooth operation.
2) Printer Verify that recorder operation is smooth, Smooth operation without abnormal
and no abnormal sound is heard. noise.
Accessories 1) Power cable, Check whether the power cable and the The power cable and the lead cable
Lead cable lead cable can be connected to or should be connected to or disconnected
disconnected from the main unit smoothly. from the main unit smoothly.
2) Clip electrode, chest Check the connection of the lead cables. The cables should be connected
electrode properly.
Electrical
Performance 1) Power supply Turn the power ON and check the screen. Verify that the screen is displayed at
power on.
2) Display Check whether waveforms are displayed No abnormality or flickering should be

on the waveform display screen. found. Waveform should be properly
displayed.
3) Print Check if waveforms are properly printed. Waveform printing possible
4) Printing speed Perform printing at 25 mm/s for 10 seconds The error for 10 seconds should be within
(25 mm/s) and check whether the error falls within ±3%.
±3%.
5) Calibration voltage Check that the error does not exceed 5% The error should be within 5%.
by holding down the 1 mV button.
Periodic Check
bl5865
Perform periodic checks according to the following "Periodic Check Procedure"

 Perform checks described in the “Periodic Check Procedure” once a year.
 If the equipment fail any check item in the Periodic Check Procedure (
be "Fail". Repair the equipment so that it passes all the check items.
P10-3 ), the overall judgment will
 Use the equipment only after the judgment for all the items is "OK".
 Check all cables, equipments, accessories, grounding resistance, leakage current, and accuracy.
Periodic Check Procedure

bl5866
9-2
Appearance
Visually check the following points according to the description of the table below.
Main Unit 1) Enclosure Verify that there is no scratch, crack, Should be free of exterior flaws, cracks,
deformation or rust on the main unit. deformation, rust.
2) Label and panel Check that the label and panel are not Should be free of peeling or dirt
peeled off or stained.
3) Key Check the key for damage. No damage

Accessories Power cable, Check for scratch and damage. There should be no scratch or damage.
Lead cable
2) Clip electrode, chest Check for dirt, rust, scratch, and damage. Should be free of dirt, rust, scratch or
electrode damage
3) Recording paper Check the condition of loading of the The recording paper should be loaded
recording paper. properly.
4) Operation Manual Verify that the operation manual is kept in It must be kept in the specified storage
the specified storage location. location.
Mechanical Inspection
Check the equipment for mechanical failures while actually operating the equipment.
Main Unit 1) Key Verify that key operation is smooth. Smooth operation.
2) Printer Verify that recorder operation is smooth, Smooth operation without abnormal
and no abnormal sound is heard. noise.
Accessories 1) Power cable, Check whether the power cable and the The power cable and the lead cable
Lead cable lead cable can be connected to or should be connected to or disconnected
disconnected from the main unit smoothly. from the main unit smoothly.
2) Clip electrode, chest Check the connection of the lead cables. The cables should be connected
electrode properly.
Maintenance Test
REFERENCE
 Touch the function keys [Menu] - [Maintenance] to place the device in maintenance mode.
9-3
Performance 1) Check clock Touch [Set Date/Time] on the maintenance Verify that the present date/time is
menu screen (Refer to "Checking the Date displayed in the Clock Setting window
and Time" on page 3-3.) and is correct.
2) Thermal printing test 1) Touch [Thermal Printing Test] on the The chart paper must not move in a
maintenance menu screen. zigzag direction.
2) Touch [Rectangular Pattern]. The chart paper must not be folded on the
Touch Speed to change the feeding rate. left and right edges.
No irregular or smeared recording.
No missed dots
Paper speed
Feeding rate 0.20in/s: 0.20in

(Within ±3%)
(Within ±3%)
(Within ±3%)
(Within ±3%)
Feeding rate 50 mm/s: 50 mm
(Within ±3%)
3) LCD test Touch [LCD Test] on the maintenance All dots should appear.
menu screen. The colors must be correct.
4) Key test 1) Touch [Key Test] on the maintenance The display corresponding to the pressed
menu screen. key must be highlighted.
2) Touch each key.
4 Touch panel test 1) Touch [Touch Panel Test] on the Correct reaction should occur at the
maintenance menu screen. touch point.
2) Touch + symbol.
6) Sound test 1) Touch [Sound Test] on the maintenance Sounds should be produced at a proper
menu screen. volume level.
2) Touch each sound.
Status Check
Inspection Item Criteria
Backup battery Must be 2.5 V or greater.
Condition of thermal print head Within ±10ºC of room temperature.
Condition of paper tray Displays "UP" when the paper tray is open and "SET" when it is closed.
Sensor detecting presence/ "Yes" should appear when paper is removed or "No" should appear when paper is loaded.
absence of paper
Electrical Safety
Refer to the following "Electrical Safety Inspection Procedure5".
9-4
Chapter 9 Maintenance and Inspection Electrical Safety Inspection Procedure
Other
Other 1) Power supply Check whether the device can be turned The device should be turned on/off both
on/off both with AC power and battery with AC power and battery power.
power.
2) Power cable Perform continuity test using a tester. Perform a continuity test using a tester
and check that the equipment is
conducting.
Electrical Safety Inspection Procedure

bl5867
Electrical safety-related testing methods and measurement equipment are stipulated in safety test standards (EN
60601-1). A dedicated safety test measuring instrument is required for performing this measurement . Check that the
measurement results do not exceed the threshold value and record the numerical values.
Safety Evaluation Test Device

Testing and inspection items in this manual are described based on the assumption that a dedicated electrical safety
tester with its accuracy controlled is used. Considering ease of test and ensuring accuracy, it is recommended to use
a dedicated safety test measuring instrument.
Contact our service personnel for more information on safety test measuring instrument.
Check Items
Electrical safety check items include the following types.
(1) Earth Leakage Current Leakage current that runs to the protective earth conductor.
(2) Touch Current Leakage current that runs through the ground from the enclosure of the device
(3) Patient Leakage Current Leakage current that runs through the ground via patient from the attaching part
(From patient connection to earth) There are two types of measuring method - direct current and alternating current.
(4) Patient Leakage Current Leakage current that runs through the ground via patient from the attaching part by
(Current when external voltage is means of the supply voltage carried on the signal input/output
applied to SIP/SOP) There are two types of measuring method - direct current and alternating current.
(5) Patient Leakage Current Leakage current that runs through the ground from the device by means of the supply
(When external voltage is applied to voltage carried on the F type attaching part through patient
patient connection of Type F Applied
Part)
(6) Patient Auxiliary Current Current that runs between attaching parts through patient
There are two types of measuring method - direct current and alternating current.
Measurement is performed under the following two conditions.

(1) Normal Condition Measurement in normal condition
(2) Single Failure Condition Condition under which a single fault occurs
9-5
Maximum allowable leakage current

Leakage Current Type B Type BF Type CF
(Unit: mA)
Normal Single Normal Single Normal Single
Condition Failure Condition Failure Condition Failure
Earth Leakage Current 5 10 5 10 5 10
Touch Current 0.1 0.5 0.1 0.5 0.1 0.5
Patient Leakage Current Direct 0.01 0.05 0.01 0.05 0.01 0.05
(From patient connection to Current
earth)
Alternating 0.1 0.5 0.1 0.5 0.01 0.05
Current
Patient Leakage Current Direct 0.01 0.05 0.01 0.05 0.01 0.05
(Current when external voltage Current
is applied to SIP/SOP)
Alternating 0.1 0.5 0.1 0.5 0.01 0.05
Current
Patient Leakage Current - - - 5 - 0.05
(When external voltage is applied to patient
connection of Type F Applied Part)
Patient Auxiliary Current Direct 0.01 0.05 0.01 0.05 0.01 0.05
Current
Alternating 0.1 0.5 0.1 0.5 0.01 0.05

Current
The "Type CF" part is applied to this equipment.
WARNING
 If value that exceeds the allowable limit is identified during an electrical safety inspection,
immediately stop using the equipment and make appropriate repairs.
Failure to repair the equipment can lead to a serious accident.
Safety Specification of this Equipment

bl5868
Classification by type of protection: Class I equipment

Classification of applied part by degree of protection: Type CF applied part
Earth Leakage Current

bl5869
1. Measurement wiring diagram
2. Allowable value
Normal condition Single failure
5mA 10mA
9-6
Touch Current
bl5870
2. Allowable value
0.1mA 0.5mA
Patient Leakage Current (From Patient Connection to Ground)

bl5871
2. Allowable value
Direct Current 0.01mA 0.05mA
Alternating Current 0.01mA 0.05 mA
Patient Leakage Current (When external voltage is applied to SIP/SOP)

bl5872
9-7
2. Allowable value
Direct Current 0.01mA 0.05 mA
Alternating Current 0.01mA 0.05 mA
Patient Leakage Current (When external voltage is applied to patient connection of Type F
Applied Part)
bl5873
2. Allowable value
Single failure
0.05 mA
Patient Auxiliary Current

bl5874
2. Allowable value
Direct Current 0.01 mA 0.05 mA
Alternating Current 0.01 mA 0.05 mA
9-8
Chapter 9 Maintenance and Inspection Replacement of the Accessories
Replacement of the Accessories
Replacement Period of Consumable Parts

bl5875
The following parts and accessories are consumable parts. The standard replacement time is as follows: The parts
may need to be replaced earlier than the time described depending on operating environment.
Any deterioration or abnormal condition is identified during operation or inspection, replace those parts
immediately.
1. Battery pack: 500 times of charging/discharging times

If the battery pack is degraded, the operation time decreases even if the battery is fully charged.
2. Thermal head: approx. 50 km (of continuous printing)
A worn thermal print head lowers the overall printout density and causes missed dots.
3. Paper driver motor: approx 1,000 hours of use (of continuous printing)
A worn paper drive motor results in unstable printing due to irregular paper feed and fluctuating paper speed.
4. Display unit backlight: 20,000 hours
A worn LCD backlight lowers the LCD brightness and may prevent the LCD from illuminating.
5. Battery for the clock: 6 years (when stored at a temperature of 25°C)
The battery powers the internal clock. When the battery is depleted, the date and time cannot be correctly recorded.
The service life may be shortened when used in high temperature, low temperature or high humidity conditions.
When the battery is depleted and the message "Replace the backup battery. The clock will be reset. (For more details,
contact your local Fukuda Denshi service representative.)" is displayed, replace the battery as soon as possible.
9-9
Chapter 9 Maintenance and Inspection Replacement of the Accessories
9-10
Chapter 10 Appendix Contents
Chapter 10 Appendix
Combination Example of Medical and Non-Medical Equipments 10-

1
Check List .................................................................................. 10-2
10-1
Chapter 10 Appendix Contents
Chapter 10 Appendix Combination Example of Medical and Non-Medical Equipments
Chapter 10 Appendix
Combination Example of Medical and Non-Medical Equipments
bl5895
The general description of possible combination of different equipments in different medical environment as
specified in IEC 60601-1 "Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance" is described below.
The system must provide the level of safety equal to that of medical electrical equipments that comply with IEC
60601-1 in the patient environment. The system must be as safe as non-medical electrical equipments that comply
with other IEC or ISO safety standards outside the patient environment. IEC 60601-1 specifies that the level of safety
offered by non-medical electrical equipments used outside the patient environment is acceptable if it conforms to the
technical standards established in the applicable IEC or the safety equivalent to those is ensured. (*1)
To construct a medical electrical system, install Equipment B as shown below assuming that ECG is Equipment A.
Outside Room used for other

Patient Environment Patient Environment purposes than diagnosis
10-1
Chapter 10 Appendix Check List
Check List
bl5894
Daily Check List

FX-8200
Remarks
Item Inspection Item Procedure, Measurement, Criteria Judgment (Repair
required)
Appearance
External 1 Exterior flaws, cracks, Check that flaws, cracks, deformation and OK/NG
Appearance deformation, rust rust are not found on the main unit.
2 Peeling and dirt on label and Check that peeling or dirt is not found on OK/NG
panel the label or the panel.
3 Key Check that the keys are not damaged. OK/NG
Accessories 1 Power cable, lead cables, nip Check that flaws and damage are not OK/NG
lead found.
2 (when used) Check for dirt, rust. Check that flaws and OK/NG
Clip electrode, chest electrode damage are not found.
3 Printing Paper Check that paper is properly loaded. OK/NG
4 Operation Manual Check that it is stored in specified location. OK/NG
Mechanical Check
Main Unit 1 Key Check that the key operation is smooth. OK/NG
2 Printer Check that the operation is smooth and that OK/NG
abnormal sound is not heard.
Accessories 1 Power cable, lead cables, nip Check for smooth operation without OK/NG
lead looseness
2 (when used) Check that no problem is found with the OK/NG

Clip electrode, chest electrode connection.
Electrical Check
Performance 1 Power Supply Check that the display appears when the OK/NG
power is turned ON.
2 Display Check that waveforms are displayed. OK/NG
3 Printing Test Check that waveforms can be printed. OK/NG
4 Printing Speed (25 mm/s) Check that the error for 10 seconds falls OK/NG
within ±3% range.
5 Calibration Voltage Check that the error is within 5%. OK/NG
Overall Judgment OK/NG

Model Name Installation location
Model FX-8200 Date of Inspection
Checked by
Serial Number Approval
Date of Purchase
bl5890
Copy this page for use.
10-2
Periodic Check List

FX-8200
Remarks
required)
Appearance
External 1 Exterior flaws, cracks, deformation, Check that flaws, cracks, deformation OK/NG
Appearance rust and rust are not found on the main
unit.
2 Peeling and dirt on label and panel Check that peeling or dirt is not found OK/NG
on the label or the panel.
3 Key Check that the keys are not damaged. OK/NG
Accessories 1 Power cable, lead cables, nip lead Check that flaws and damage are not OK/NG
found.
2 (when used) Check for dirt, rust.Check that flaws OK/NG

Clip electrode, chest electrode and damage are not found.
3 Printing Paper Check that paper is properly loaded. OK/NG

4 Operation Manual Check that it is stored in specified OK/NG
location.
Mechanical Check
Main Unit 1 Key Check that the key operation is OK/NG
smooth.
2 Printer Check that the operation is smooth OK/NG

and that abnormal sound is not heard.
Accessories 1 Power cable, lead cables, nip lead Check for smooth operation without OK/NG
looseness
2 (when used) Check that no problem is found with OK/NG

Clip electrode, chest electrode the connection.
Electrical Check
Performance 1 Power Supply Check that the display appears when OK/NG
the power is turned ON.
2 Display Check that waveforms are displayed. OK/NG
3 Printing Test Check that waveforms can be printed. OK/NG
4 Printing Speed (25 mm/s) Check that the error for 10 seconds OK/NG
falls within ±3% range.
5 Calibration Voltage Check that the error is within 5%. OK/NG
10-3
Remarks
required)
Maintenance 1 Backup battery Backup Battery Voltage 2.5V and OK/NG
above
2 Clock Setting Check that correct time is displayed. OK/NG
3 Printing Test Check that the printing paper is fed OK/NG

straight.
Check that both sides of the printing
paper are not creased.
Check that the printing is not uneven
or too light.
Check that there is no missing dots.
Check that feeding speed is 5, 10, 25
or 50 mm/s (within ±3%)
4 Touch Panel Adjustment Adjust the touch panel using an object OK/NG
Display/touch panel test with soft end.
Check that all dots are lit and correct
text, lines and colors are displayed.
It should correctly respond at the
touch point.
5 KEY/LED/Sound Test Check that the pressed key is OK/NG

displayed, the LED lights, and buzzer
sounds.
Remarks
required)
Electrical Safety 1 Earth Leakage Current
Normal Condition 5 mA and mA OK/NG

below
Single Failure 10 mA and mA OK/NG

Condition below
2 Touch Current
Normal Condition 0.1 mA and mA OK/NG

below
Single Failure 0.5 mA and mA OK/NG

Condition below
3 Patient Leakage Current (from patient connection to earth)
Direct Current
below

Condition below
Alternating Current

below

Condition below
4 Patient Leakage Current (Current when external voltage is applied to SIP/SOP)
Direct Current
10-4
Remarks
required)
below

Condition below
Alternating Current

below
Single Failure 0.05mA and mA OK/NG

Condition below
5 Patient leakage current (Current when external voltage is applied to the patient connecting part in the Type
F attaching part)
Direct Current
below

Condition below
Alternating Current
Normal Condition 0.01mA and mA OK/NG

below

Condition below
6 Patient Auxiliary Current
Direct Current

below

Condition below
Alternating Current

below

Condition below
Remarks
required)
Other 1 Power Supply Check that both AC power and rechargeable OK/NG
battery power can be turned on/off.
2 Power Supply Cable Perform a continuity test using a tester and OK/NG
check that the equipment is conducting.
Overall Judgment OK/NG
Model Name Installation

location
Model FX-8200 Date of

Inspection
Checked by
Serial number Approval
Date of Purchase
Copy this page for use.
10-5
10-6
The company and product names used in this manual are trademarks or registered trademarks of respective companies.
3-39-4 Hongo, Bunkyo-ku, Tokyo, Japan
Tel: +81-3-5684-1455 Fax: +81-3-3814-1222
http://www.fukuda.com
4R0101440 201706

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Service Manual

Fukuda Denshi Co., Ltd.

© 2017 Fukuda Denshi Co., Ltd.

Chapter 1 General Description

Chapter 2 Operational Description

Chapter 3 Wire Connection Diagram/Block Diagram

Block Diagram .................................................................................................................... 3-1

Chapter 4 Spare Parts List

Chapter 5 Disassembly and Assembly Procedure

Chapter 6 Software Update

Trouble at Startup............................................................................................................................ 7-4

Chapter 9 Maintenance and Inspection

Touch Current.................................................................................................................................. 9-7

About This Manual

Composition of This Manual

2.Operational Description Provides information on operational description of each block diagram.

4.Spare Parts List Provides information of the spare parts list.

5.Disassembly and Assembly 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.

Reminders to Use the Equipment Safely

 Ensure that you use replacement parts with FX-8200 specification.

An Example of Safety Symbol

Labels for Assuring Safety

Symbols on the Equipment

The following is a list of symbols used on this equipment.

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

WEEE (Waste Electrical and Electronics Equipment)

2 Degree of protection against electrical shock

3 Degree of protection against ingress of water

6 Classification of Sterilization Method

Precautions when Using with Other Equipment

DANGER Non-Explosion Proof

 Do not ground with a gas pipe. Explosion or fire may result.

Connecting the Power Cable

Precautions for Safe Operation of Medical Electrical Equipment

Precautions Concerning the LAN

CAUTION Precautions when Using with Wireless LAN Adapter

Storage, Transportation, and Disposal

Storage and Cleaning

 Perform daily checks to maintain safety.

 Perform regular inspections every 12 months to maintain safety.

Disposing the Equipment

Cleaning and Disinfection

WARNING Electrodes, Lead Cables

Precautions for Safe Operation under Electromagnetic Influence

CAUTION Measures to ensure Electromagnetic Compatibility (EMC)

Compliance to the Electromagnetic Emissions

Power supply voltage

Compliance to the Electromagnetic Immunity (1)

Surge: ±0.5,1kV: ±0.5,1kV: Mains power quality should be that of a typical

Magnetic field of 3A/m 3A/m Power frequency magnetic fields should be at