Fukuda Denshi HR-800 User manual

HR-800
●●●●●●●●●●●●●●●●●●●●●●●●●●●●
Recorder Module
Service Manual
zBefore setting up/maintenance, please read this “Service Manual” thoroughly.
zAfter reading, keep this manual for future reference.

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Service Manual (No. ): Q’ty 1
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Fukuda Denshi Co., Ltd.
Development & Production Support Dept.
2-35-8 Hongo Bunkyo-ku, Tokyo, 113-8420 Japan
Receivedby
of (Company/Hospital)
onthedayof

Revision History
Model Name
HR-800 Service Manual
Edition Revised Items Reason of the Revision Revised Date
1 － New Edition 2011.08

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Preface
Thank you for purchasing this product.
Before using this product, read the following precautions to make sure the product is
used correctly and safely.
Safety Precautions·························································ii
Graphic Symbols························································ii
Precautions for Safe Operation of Medical Electrical
Equipment ································································· iii
Precautions about the Maintenance··························iv
Non-Explosion Proof··················································iv
Precautions about Magnetic Resonance Imaging ·····iv
Precautions about Connections to Peripheral Devices
···················································································v
Accessories and Optional Accessories·······················v
Precautions about the HR-800 System ······················v
Disposing of Equipment, Accessories, or Components
··················································································vi
Precautions about Transportation······························vi
Electromagnetic Compatibility····································vii
Precautions for Safe Operation under Electromagnetic
Influence··································································· vii
EMC Guidance························································· vii
i

Safety Precautions
yRead the “Safety Precautions” thoroughly before use to ensure correct and safe use of the
product.
yMake sure to follow the precautions indicated below, as these are important messages related
to safety.
DANGER Failure to follow this message may cause immediate threat of death or
serious injury, or complete failure of the equipment.
WARNING Failure to follow this message may result in death or serious injury, or
complete failure of the equipment.
CAUTION Failure to follow this message may cause injury or failure to the
equipment.
NOTE A note is not related to product safety, but provides information about the
correct use and operating procedures to prevent incorrect operation and
malfunction of the equipment.
Graphic Symbols
Refer following for the meaning of the symbols indicated on the equipment.
Symbol Description
Caution; refer to accompanying documents
Indicates the need to refer to related accompanying documents before
operation.
ii

Precautions for Safe Operation of Medical Electrical Equipment
CAUTION
Read the following precautions thoroughly to correctly operate the
device.
zUsers should have a thorough knowledge of the operation before using
this system.
zPay attention to the following when installing and storing the equipment.
yDo not install or store in an area where the equipment will be subject
to splashing water.
yDo not install or store in an area where the environmental conditions,
such as atmospheric pressure, temperature, humidity, ventilation,
sunlight, dust, sodium, sulfur, will adversely affect the system.
yPlace the equipment on a stable surface where there is no
inclination, vibration, or shock (including during transportation).
yDo not install or store in an area where there are chemical or gasses
stored.
yVerify the power frequency, voltage and allowable current (or power
consumption).
yEnsure the grounding is proper by connecting the accompanying
power cable to the hospital grade outlet.
zBefore operating the equipment, verify the following items.
yCheck the cable connection and polarity to ensure proper operation
of the unit.
yMake sure the power system has adequate earth ground.
yEnsure that all cables are firmly and safely connected.
yPay special attention when the equipment is used in conjunction with
other equipment as it may cause erroneous judgment and danger.
zDuring operation of the system, verify the following items.
yAlways observe the system and patient to ensure safe operation of
the equipment.
yIf any abnormality is found on the equipment or patient, take
appropriate measures such as ceasing operation of the equipment in
the safest way for the patient.
yDo not allow the patient to come in contact with the device.
yMake sure not to touch all Signal Input/Output parts in the device
with the patient at the same time.
zAfter using the system, verify the following items.
yWhen unplugging the cables, do not apply excessive force by pulling
on the cord. Pull by the connector part of the cable.
yClean the accessories and cables, and keep them together in one
place.
yKeep the unit clean to ensure proper operation of the next use.
zIf the equipment is damaged and in need of repair, user should not
attempt service. Label the unit “OUT OF ORDER”and contact our
service representative.
zDo not remodel the equipment.
zMaintenance Check
yMake sure to periodically check the equipment, accessories and
cables.
yBefore reusing the device that has been left unused for a while, make
sure that the device works normally and safely.
iii

Precautions about the Maintenance
Safety Inspection and Maintenance
For safe operation of the equipment, regular inspection and maintenance is required. Once a year,
check all cables, devices, and accessories for damage, earth impedance, earth and leakage
currents, and all alarm functions. Also, ensure that all safety labels are legible. Maintain a record of
these safety inspections.
Immediate maintenance has to be carried out if ;
ythe equipment was subjected to extreme mechanical stress, e.g. after a heavy fall.
ythe equipment was subjected to liquid spill.
ythe monitoring function is interrupted or disturbed.
yparts of the equipment enclosure are cracked, removed, or lost.
yany connector or cable shows signs of deterioration.
WARNING Never open the housing while the equipment is in operation or connected
to hospital grade outlet as it may result in electric shock.
Maintenance, Modifications, and Repairs
Fukuda Denshi is liable for the safety, reliability, and performance of its equipment only if;
yMaintenance, modifications, and repairs are carried out by authorized personnel.
yComponents are used in accordance with Fukuda Denshi operating instructions.
Non-Explosion Proof
DANGER
Never operate the equipment in the presence of flammable anesthetics,
high concentration of oxygen, or inside hyperbaric chamber. Also, do not
operate the equipment in an environment in which there is a risk of
explosion.
Explosion or fire may result.
Precautions about Magnetic Resonance Imaging
WARNING
zDo not operate this equipment in magnetic resonance imaging (MRI)
environments.
zWhen conducting MRI test, remove the electrodes and sensors
connected to the patient (test subject).
The local heating caused by the induced electromotive force may
cause burn injury to the patient (subject). For details, refer to the
operation manual for the MRI testing device.
iv

Precautions about Connections to Peripheral Devices
In the interest of safe and sufficient performance of this equipment, the connection of other
manufacturers’ equipment to the monitor is not authorized, unless the connection is explicitly
approved by Fukuda Denshi. It is the user’s responsibility to contact Fukuda Denshi to determine
the compatibility and warranty status of any connection made to another manufacturer’s
equipment.
WARNING For the connector with mark, only the peripheral devices specified b
Fukuda Denshi should be connected with the given procedure. Use of an
unspecified device may cause electric shock to the patient and/or ope
due to excessive leakage current.
y
rator
When connecting peripheral devices to this unit, it is the user’s responsibility to verify that the
overall system complies with EN/IEC 60601-1-1, “Collateral Standard: Safety Requirements for
Medical Electrical Systems”.
Accessories and Optional Accessories
WARNING Use only the cables specified by Fukuda Denshi.
Use of other cables may result in increase in emission or decrease in
immunity.
Precautions about the HR-800 System
DANGER When connecting to other equipments, contact our service
representative.
Danger such as electric shock may result to the patient and operator.
WARNING
zDo not connect a unit or cable not authorized by Fukuda Denshi to
any I/O connector. If done so by mistake, this system cannot deliver
its maximum performance and the connected units may be damaged,
resulting in a safety hazard.
zIf this equipment is used under an environment not fulfilling the
specified condition, not only that the equipment cannot deliver its
maximum performance, the equipment may be damaged and safety
cannot be ensured. If using the equipment under condition other than
specified, contact your nearest representative.
When lifting this unit, hold the bottom part of the unit.
v

CAUTION
zSystems
yUse only the accessories specified for this device. Otherwise, proper
function cannot be executed.
yFor quality improvement, specifications are subject to change without
prior notice.
yThis equipment is intended to be used for only one patient.
yThe installation of this equipment should be performed by our service
representative or a person who is well acquainted with this
equipment.
yIf not using for a long period, make sure to turn OFF the power of the
main unit.
zMaintenance
yClean the device frequently so stains can be removed easily.
yTo prevent injury, it is recommended to wear gloves when cleaning
the equipment.
yDo not allow liquids or cleaning solution to enter the equipment or
connectors.
yDo not use organic solvents, thinner, toluene or benzene to avoid
damaging the resin case.
yDo not polish the housing with abrasive or chemical cleaner.
yWhen sterilizing the entire room using a spray solution, pay close
attention not to have liquids get into the monitor or connectors.
yUse only neutral detergent to clean the housing. Do not use chemical
cloth, scrub brush, abrasive, polishing powder, hot water, volatile
solvent and chemicals (cleanser, thinner, toluene, benzine, benzol,
and synthetic detergent for house and furniture), or sharp-edged
tools. The surface resin coating may be damaged, resulting in
discoloration, scratches, and other problems.
yDo not open the housing.
yAvoid alcohol or other liquids from getting into the device.
yReplace the periodic replacement parts periodically as specified.
Disposing of Equipment, Accessories, or Components
CAUTION When disposing of this product, accessories, or components, use an
industrial waste distributor. Do not dispose of as ordinary waste.
Precautions about Transportation
When transporting HR-800, pack it with specified packing materials.
Reference Refer to “2. Specification”for Environmental Conditions during transportation.
vi

Electromagnetic Compatibility
The performance of this device under electromagnetic environment complies with
EN/IEC60601-1-2(2007).
Precautions for Safe Operation under Electromagnetic Influence
CAUTION
If any sorts of electromagnetic wave, magnetic field, or static electricity
exist around the device, noise interference or malfunction of the device
may occur. If any unintended malfunction or noise occurs during
monitoring, check the magnetic influence and take appropriate
countermeasures.
The following are examples of the common cause and countermeasures.
zCellular Phone
The radio wave may cause malfunction to the device.
Cellular phones and radio sets should be turned off in the room
(building) where medical device is located.
zStatic Electricity
In a dry environment (room), static electricity is likely to occur. Take the
following countermeasures.
yBoth operator and patient should remove any static electricity before
entering the room.
yHumidify the room.
zLightning
yA lightning nearby may induce excessive voltage to the equipment. If
any danger is suspected, use the uninterruptible power supply
system.
zHigh frequency noise interference from other device through the power
outlet
yCheck where the noise is originated and remove it using filtering
device, etc.
yStop using the device that is originating the noise.
yUse other power outlet.
EMC Guidance
This equipment complies with EN/IEC60601-1-2(2007). 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.
Therefore, 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 technician.
vii

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ix
Contents
Preface
Chapter 1 General Description This chapter describes the outline of this equipment.
Chapter 2 Specification This chapter describes electrical and mechanical
specification.
Chapter 3
Names of Parts and Their
Functions This chapter describes connectors of this unit
Chapter 4 Operational Description This chapter describes block diagram and function of
this unit.
Chapter 5 Wiring Diagram This chapter describes wiring diagram.
Chapter 6 Spare Parts List This chapter describes electrical parts and cables inside
equipment.
Chapter 7 Assembly Diagram This chapter describes assembly diagram.
Chapter 8
Software Upgrade Procedure This chapter describes Software Upgrade.
Chapter 9 Caution Label This chapter describes caution labels attached to this
unit.
Chapter 10 Troubleshooting This chapter describes points to be checked and
procedure toward trouble symptoms.
Chapter 11 Maintenance This chapter explains Test Menu for maintenance and
how to store and clean.
Chapter 12 Periodic Check This chapter explains daily check and periodic check.

x
Preface
Safety Precautions··························································ii
●Graphic Symbols··············································ii
●Precautions for Safe Operation of Medical
Electrical Equipment···········································iii
●Precautions about the Maintenance················iv
●Non-Explosion Proof ·······································iv
●Precautions about Magnetic Resonance
Imaging·······························································iv
●Precautions about Connections to Peripheral
Devices································································v
●Accessories and Optional Accessories ············v
●Precautions about the HR-800 System············v
●Disposing of Equipment, Accessories, or
Components························································vi
●Precautions about Transportation ···················vi
Electromagnetic Compatibility······································· vii
●Precautions for Safe Operation under
Electromagnetic Influence··································vii
●EMC Guidance···············································vii
Chapter 1 General Description
HR-800 Recorder Module ··········································· 1-2
HR-800 Recorder Module Description··················· 1-2
Chapter 2 Specification
HR-800 Recorder Module ··········································· 2-2
HR-800 Recorder Module Specification ················ 2-2
Chapter 3 Names of Parts and Their
Functions
HR-800 Recorder Module ··········································· 3-2
HR-800 Recorder Module Features······················· 3-2
HR-800 Recorder Module Name of Parts and Their
Functions······························································· 3-2
Chapter 4 Operational Description
HR-800 Recorder Module ··········································· 4-2
HR-800 Recorder Module Block Diagram ············· 4-2
HR-800 Recorder Module Board Block Diagram··· 4-3
Circuit Explanation················································· 4-5
Chapter 5 Wiring Diagram
HR-800 Recorder Module············································5-2
Wiring Diagram (wiring diagram of each block)······5-2
Wiring Diagram (Block Diagram of the Recorder
Unit)········································································5-3
Chapter 6 Spare Parts List
HR-800 Spare Parts·····················································6-2
Chapter 7 Assembly Diagram
HR-800 Assembly1 HR-800-01A······················7-2
HR-800 Assembly2 HR-800-02A······················7-3
Chapter 8 Software Upgrade Procedure
Software Upgrade Procedure·······································8-2
Preparation·····························································8-2
Upgrade··································································8-2
Upgrade check ·······················································8-2
Chapter 9 Caution Label
Caution Label·······························································9-2
HR-800···································································9-2
Chapter 10 Troubleshooting
HR-800 Recorder Module ··········································10-2
Troubleshooting····················································10-2
●Troubleshooting for HR-800 Main Unit········10-2
●Troubleshooting for the DS-8500system
Technical Alarm Sound···································10-3
Chapter 11 Maintenance
Test Menu··································································11-2
How to Display the Test Menu······························11-2
Test Menu Description··········································11-2
Storage of the Equipment and Recording Paper········11-9
Storage·································································11-9
Cleaning···································································11-10

xi
Cleaning the Housing and cables······················ 11-10
Chapter 12 Periodic Check
Periodic Check Daily and Periodic Check··········· 12-2
About the Periodic Check···································· 12-2
●Daily Check················································ 12-2
●Periodic Check··········································· 12-2
Daily Check ························································· 12-3
●Daily Check Procedure······························· 12-3
●Daily Check List·········································· 12-4
Periodic Check ···················································· 12-5
●Introduction················································· 12-5

xii
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1 － 1
General Description
Chapter 1
HR-800 Recorder Module ··········································1-2
HR-800 Recorder Module General Description ······1-2

1 － 2
HR-800 Recorder Module
This section explains the general description of HR-800 Recorder Module.
HR-800 Recorder Module General Description
The Recorder Module HR-800 is used to record waveforms, numeric data and graphic trend
monitored on the DS-8500 system on the recording paper.
With its high-end thermal head, up to 3 channels of waveforms can be recorded in high resolution.
Furthermore, graphics such as trend graph and tabular trend can also be recorded.
The recording speed can be set to 25mm/s or 50mm/s.

Specification
Chapter 2
HR-800 Recorder Module ··········································2-2
HR-800 Recorder Module Specification ·················2-2
2 － 1

HR-800 Recorder Module
This section explains the specification of HR-800 Recorder Module.
HR-800 Recorder Module Specification
Dimensions (mm)
87(W)×109(H)×100(D) mm *not including the protrusion.
Weight (kg)
0.54kg
Environmental Conditions
Operational Temperature : 10 to 40°C
Operational Humidity : 30 to 85% (non-condensing)
Storage Temperature ：-10 to 60°C
Storage Humidity ：10 to 95％(at 60°C)
Safety (DS-8500 system)
General Standard (CE): EN 60601-1:1990+A1:1993+A2:1995
(Medical Electrical Equipment- Part 1: General Requirements for Safety)
EN 60601-1-1:2001
(Medical Electrical Equipment- Part 1-1: General Requirements for Safety
- Collateral standard: Safety Requirements for Medical Electrical Systems)
EMC Standard (CE) : EN 60601-1-2 Ed. 3.0:2007
(Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance Collateral standard:
Electromagnetic compatibility – Requirements and tests)
General Standard :IEC 60601-1:1998+A1:1991+A2:1995
(Medical Electrical Equipment- Part 1: General Requirements for Safety)
IEC 60601-1-1:2000
(Medical Electrical Equipment- Part 1-1: General Requirements for Safety
- Collateral standard: Safety Requirements for Medical Electrical Systems)
EMC Standard :IEC 60601-1-2 Ed. 3.0:2007
(Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance Collateral standard: Electromagnetic
compatibility – Requirements and tests)
Classification
Waterproof Level : IPX0 (no protection)
Sterilization and Disinfection : Only Cleaning
Usage in Presence of Flammable Gas : none
Operation mode : Continuous operation equipment
2 － 2