Nihon-Kohden ECG-9620 Service manual
ECG-9620L
ECG-9620M
ECG-9620N
ECG-9620P
ECG-9620S
ECG-9620T
ECG-9620U
SERVICE MANUAL
cardiofax
ELECTROCARDIOGRAPH
ECG-9620
08CK2.782.00516E
CONTENTS
Contents
GENERAL HANDLING PRECAUTIONS .................................................................................i
WARRANTY POLICY .............................................................................................................ii
EMC RELATED CA UTION..................................................................................................... iii
Conventions Used in this Manual and Instrument..................................................................iv
Dangers, Warnings, Cautions and Notes.....................................................................iv
Explanations of the Symbols in this Manual and Instrument ........................................v
Section 1 General ...................................................................................1C.1
Introduction ......................................................................................................................... 1.1
General Information on Servicing ....................................................................................... 1.2
Service Policy, Service Parts and Patient Safety Checks ................................................... 1.4
Service Policy ........................................................................................................... 1.4
Service Parts ............................................................................................................ 1.4
Patient Saf ety Checks............................................................................................... 1.5
Maintenance Equipments and Tools ......................................................................... 1.5
General Safety Inf ormation ................................................................................................. 1.6
Specifications.................................................................................................................... 1.11
Panel Descriptions............................................................................................................ 1.14
Front Panel ............................................................................................................. 1.14
Left Side Panel........................................................................................................ 1.14
Operation Panel...................................................................................................... 1.15
Right Side Panel ..................................................................................................... 1.15
Rear Panel.............................................................................................................. 1.16
Composition...................................................................................................................... 1.17
Standard Components............................................................................................ 1.17
Options ................................................................................................................... 1.17
Location ............................................................................................................................ 1.18
Section 2 Maintenance ...........................................................................2C.1
Replacement....................................................................................................................... 2.1
Periodic Replacement Schedule............................................................................... 2.1
Cleaning and Lubrication .................................................................................................... 2.2
Cleaning and Greasing Schedules ........................................................................... 2.2
Cleaning the Paper Mark Sensor and P aper Empty Sensor..................................... 2.2
Cleaning the Motor Rotation Sensor and Lubricating the Motor Gear and Gear
Meshed with Motor Gear .......................................................................................... 2.3
Maintenance Check Sheet.................................................................................................. 2.5
Section 3 Troubleshooting and System Error Message ......................3C.1
Troubleshooting Flowchart .................................................................................................. 3.1
T roub leshooting T able ......................................................................................................... 3.4
Troubleshooting General Operation Problem ............................................................ 3.4
Service Manual ECG-9620 C.1
CONTENTS
Troubleshooting Recording Problem......................................................................... 3.6
System Error Message ....................................................................................................... 3.7
Section 4 System Test, Adjustment and Setting ..................................4C.1
System Test ........................................................................................................................ 4.1
Overall ...................................................................................................................... 4.1
Calling up the System Test Level 1 ........................................................................... 4.2
Calling up the System Test Level 2 ........................................................................... 4.3
Entering the System Test Number ............................................................................ 4.4
Executing the System Test........................................................................................ 4.5
Quitting the System Test ........................................................................................... 4.6
Exiting the System Test Mode................................................................................... 4.6
Demonstration .................................................................................................................... 4.7
Recorder ............................................................................................................................. 4.8
Thermal Head ................................................................................................................... 4.10
Key.................................................................................................................................... 4.11
Memory............................................................................................................................. 4.12
Single Memory Test Mode ...................................................................................... 4.13
Continuous Memory Test Mode .............................................................................. 4.13
LCD/LED........................................................................................................................... 4.14
Input Unit .......................................................................................................................... 4.16
Calibration......................................................................................................................... 4.17
Communication................................................................................................................. 4.18
CRO/EXT1........................................................................................................................ 4.20
System Setup Initialization................................................................................................ 4.22
ECG Findings List Recording............................................................................................ 4.23
Recording Resolution Setting ........................................................................................... 4.24
Date and Time Setting ...................................................................................................... 4.25
Setting the Date and Time ...................................................................................... 4.25
Section 5 Board/Unit Description..........................................................5C.1
Block Diagram..................................................................................................................... 5.1
Pow er Unit .......................................................................................................................... 5.2
ECG Control Board ............................................................................................................. 5.2
Section 6 Disassembly...........................................................................6C.1
Before You Begin................................................................................................................. 6.1
Warnings and Cautions ............................................................................................ 6.1
Required T ools.......................................................................................................... 6.1
Cable Connection ............................................................................................................... 6.2
Removing the Upper Casing............................................................................................... 6.4
Removing the Magazine and Recording Paper ........................................................ 6.4
Removing the Battery Pack ...................................................................................... 6.4
Removing the Upper Casing..................................................................................... 6.4
Removing the Thermal Head and Motor Assy .................................................................... 6.5
Removing the Thermal Head.................................................................................... 6.5
C.2 Service Manual ECG-9620
CONTENTS
Removing the Motor Assy......................................................................................... 6.6
Removing the ECG Control Board...................................................................................... 6.6
Removing the Power Board ................................................................................................ 6.8
Removing the Power Board ...................................................................................... 6.8
Replacing the Po wer Fuse and Battery Fuse ........................................................... 6.9
Removing the Key Board and LCD Unit............................................................................ 6.10
Section 7 Replaceable Parts List...........................................................7C.1
Instrument........................................................................................................................... 7.2
Section 8 Connector Pin Assignment ..................................................... 8.1
Attaching the Ferrite Core......................................................................................... 8.1
EXT-IN Connector..................................................................................................... 8.2
CRO-OUT Connector ............................................................................................... 8.2
SIO Connector.......................................................................................................... 8.2
Service Manual ECG-9620 C.3
GENERAL HANDLING PRECAUTIONS
This device is intended for use only by qualified medical personnel.
Use only Nihon Kohden approved products with this device. Use of non-approved products or in
a non-approved manner may affect the performance specifications of the device. This includes,
but is not limited to, batteries, recording paper, pens, extension cables, electrode leads, input
boxes and AC power.
Please read these precautions thoroughly before attempting to operate the instrument.
1. To safely and effectively use the instrument, its operation must be fully understood.
2. When installing or storing the instrument, take the following precautions:
(1) Avoid moisture or contact with water, dust, extreme atmospheric pressure, excessive humidity and temperatures,
poorly ventilated areas, and saline or sulphuric air.
(2) Place the instrument on an even, level floor. Avoid vibration and mechanical shock, even during transport.
(3) Avoid placing in an area where chemicals are stored or where there is danger of gas leakage.
(4) The power line source to be applied to the instrument must correspond in frequency and voltage to product
specifications, and have sufficient current capacity.
(5) Choose a room where a proper grounding facility is available.
3. Before Operation
(1) Check that the instrument is in perfect operating order.
(2) Check that the instrument is grounded properly.
(3) Check that all cords are connected properly.
(4) Pay extra attention when the instrument is in combination with other instruments to avoid misdiagnosis or other
problems.
(5) All circuitry used for direct patient connection must be doubly checked.
(6) Check that battery level is acceptable and battery condition is good when using battery-operated models.
4. During Operation
(1) Both the instrument and the patient must receive continual, careful attention.
(2) Turn power off or remove electrodes and/or transducers when necessary to assure the patient’s safety.
(3) Avoid direct contact between the instrument housing and the patient.
5. To Shutdown After Use
(1) Turn power off with all controls returned to their original positions.
(2) Remove the cords gently; do not use force to remove them.
(3) Clean the instrument together with all accessories for their next use.
6. The instrument must receive expert, professional attention for maintenance and repairs. When the instrument is
not functioning properly, it should be clearly marked to avoid operation while it is out of order.
7. The instrument must not be altered or modified in any way.
8. Maintenance and Inspection:
(1) The instrument and parts must undergo regular maintenance inspection at least every 6 months.
(2) If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect
operating condition.
Service Manual ECG-9620 i
(3) Technical information such as parts list, descriptions, calibration instructions or other information is available for
qualified user technical personnel upon request from your Nihon Kohden distributor.
9. When the instrument is used with an electrosurgical instrument, pay careful attention to the application and/or
location of electrodes and/or transducers to avoid possible burn to the patient.
10. When the instrument is used with a defibrillator, make sure that the instrument is protected against defibrillator
discharge. If not, remove patient cables and/or transducers from the instrument to avoid possible damage.
WARRANTY POLICY
Nihon Kohden Corporation (NKC) shall warrant its products against all defects in materials and workmanship for one year
from the date of delivery. However, consumable materials such as recording paper, ink, stylus and battery are excluded from
the warranty.
NKC or its authorized agents will repair or replace any products which prove to be defective during the warranty period,
provided these products are used as prescribed by the operating instructions given in the operator’s and service manuals.
No other party is authorized to make any warranty or assume liability for NKC’s products. NKC will not recognize any other
warranty, either implied or in writing. In addition, service, technical modification or any other product change performed by
someone other than NKC or its authorized agents without prior consent of NKC may be cause for voiding this warranty.
Defective products or parts must be returned to NKC or its authorized agents, along with an explanation of the failure.
Shipping costs must be pre-paid.
This warranty does not apply to products that have been modified, disassembled, reinstalled or repaired without Nihon
Kohden approval or which have been subjected to neglect or accident, damage due to accident, fire, lightning, vandalism,
water or other casualty, improper installation or application, or on which the original identification marks have been
removed.
ii Service Manual ECG-9620
EMC RELATED CAUTION
This equipment and/or system complies with the International Standard IEC60601-1-2 for electromagnetic
compatibility for medical electrical equipment and/or system. However, an electromagnetic environment
that exceeds the limits or levels stipulated in the IEC60601-1-2, can cause harmful interference to the
equipment and/or system or cause the equipment and/or system to fail to perform its intended function or
degrade its intended performance. Therefore, during the operation of the equipment and/or system, if
there is any undesired deviation from its intended operational performance, you must avoid, identify and
resolve the adverse electromagnetic effect before continuing to use the equipment and/or system.
The following describes some common interference sources and remedial actions:
1. Strong electromagnetic interference from a nearby emitter source such as an authorized radio station
or cellular phone:
Install the equipment and/or system at another location if it is interfered with by an emitter source such
as an authorized radio station. Keep the emitter source such as cellular phone away from the
equipment and/or system.
2. Radio-frequency interference from other equipment through the AC power supply of the equipment
and/or system:
Identify the cause of this interference and if possible remove this interference source. If this is not
possible, use a different power supply.
3. Effect of direct or indirect electrostatic discharge:
Make sure all users and patients in contact with the equipment and/or system are free from direct or
indirect electrostatic energy before using it.
4. Electromagnetic interference with any radio wave receiver such as radio or television:
If the equipment and/or system interferes with any radio wave receiver, locate the equipment and/or
system as far as possible from the radio wave receiver.
If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden Corporation
subsidiary or distributor for additional suggestions.
The CE mark is a protected conformity mark of the European Community. The products herewith comply
with the requirements of the Medical Device Directive 93/42/EEC.
The CE mark is applied only to the ECG-9620L/M/N Electrocardiograph.
This equipment complies with EUROPEAN STANDARD EN-60601-1-2 (1993) which requires EN-55011, class
B.
Service Manual ECG-9620 iii
Conventions Used in this Manual and Instrument
Dangers, Warnings, Cautions and Notes
Warnings, cautions and notes are used in this manual to alert or signal the reader to specific information.
DANGER
A danger is used to alert the user to a hazardous situation which will cause death or serious injury.
WARNING
A warning alerts the user to possible injury or death associated with the use or misuse of the instrument.
CAUTION
A caution alerts the user to possible injury or problems with the instrument associated with its use or
misuse such as instrument malfunction, instrument failure, damage to the instrument, or damage to other
property.
NOTE
A note provides specific information, in the form of recommendations, prerequirements, alternative
methods or supplemental information.
iv Service Manual ECG-9620
Explanations of the Symbols in this Manual and Instrument
The following symbols found in this manual/instrument bear the respective descriptions as given.
Cardiograph
Symbol Description Symbol Description
Attention, consult operator’s
manual
Equipotential terminal Serial number
Serial input/output terminal
Input terminal for analog signal
Output terminal for analog
signal
Eject (magazine release button)
Alternative current
Type CF applied part
Date of manufacture
The CE mark is a protected
conformity mark of European
Community. The products
herewith comply with the
requirements of the Medical
Device Directive 93/42/EEC.
Protective earth
Patient cable
The CE mark is applied only to the
ECG-9620L/M/N Electrocardiograph.
Symbol Description Symbol Description
Attention, consult operator’s
manual
Defibrillation-proof
Type CF applied par
The CE mark is a protected
conformity mark of European
Community. The products
herewith comply with the
requirements of the Medical
Device Directive 93/42/EEC.
Service Manual ECG-9620 v
Operation panel
Symbol Description Symbol Description
F1
Alternating current
“On” only for a part of
equipment
“Off” only for a part of
equipment
Battery charging
Battery check
/
Copy / Calibration / Automatic / Manual control
0
F1 function key
1
/
CLR
Rhythm
5
Age
6
Sex
7
Paper feed / Mark
8
Filter
9
Clear
On screen
F2
F3
Symbol Description
F2 function key Start/Stop recording
2
F3 function key
3
Mode
4
QRS sync mark
CAL mark
ENT
Enter
A key with a numeric number is used to enter
numbers in the System Setup screen and paient
information.
vi Service Manual ECG-9620
Section 1 General
Introduction ........................................................................................................................ 1.1
General Information on Servicing ...................................................................................... 1.2
Service Policy, Service Parts and Patient Safety Chec ks .................................................. 1.4
Service Policy .......................................................................................................... 1.4
Service Parts ........................................................................................................... 1.4
Patient Safety Checks.............................................................................................. 1.5
Maintenance Equipments and Tools ........................................................................ 1.5
General Safety Inf ormation ................................................................................................ 1.6
Specifications................................................................................................................... 1.11
Panel Descriptions........................................................................................................... 1.14
Front Panel ............................................................................................................ 1.14
Left Side Panel....................................................................................................... 1.14
Operation Panel..................................................................................................... 1.15
Right Side Panel .................................................................................................... 1.15
Rear Panel............................................................................................................. 1.16
Composition..................................................................................................................... 1.17
Standard Components........................................................................................... 1.17
Options .................................................................................................................. 1.17
Location ........................................................................................................................... 1.18
Service Manual ECG-9620 1C.1
Introduction
1. GENERAL
This service manual provides useful information to qualified service personnel to
understand, troubleshoot, service, maintain and repair the ECG-9620L/M/N/P/S/T/
U Electrocardiograph (referred to as “the instrument” in this service manual).
The System test, Adjustment and Setting section in this service manual describes
the maintenance that should be performed by qualified service personnel. The
Maintenance section in the operator’s manual describes the maintenance that can
be performed by the user.
The information in the operator’s manual is primarily for the user. However, it is
important for service personnel to thoroughly read the operator’s manual and
service manual before starting to troubleshoot, service, maintain or repair this
instrument. This is because service personnel need to understand the operation of
the instrument in order to effectively use the information in the service manual.
Service Manual ECG-9620 1.1
1. GENERAL
General Information on Servicing
Note the following information when servicing the instrument.
Safety
• There is the possibility that the outside surface of the instrument,
such as the operation keys, could be contaminated by contagious
germs, so disinfect and c lean the instrument before servicing it.
When servicing the instrument, wear rubber gloves to protect
yourself from infection.
• There is the possibility that when the lithium battery is broken, a
solvent inside the lithium battery could flow out or a toxic substance
inside it could come out. If the solvent or toxic substance touches
your skin or gets into your eye or mouth, immediately wash it with a
lot of water and see a physician.
CAUTIONS
Liquid ingress
The instrument is not waterproof, so do not install the instrument
where water or liquid can get into or fall on the instrument. If liquid
accidentally gets into the instrument or the instrument accidentally
drops into liquid, disassemble the instrument, clean it with clean
water and dry it completely. After reassembling, verify that there is
nothing wrong with the patient safety checks and function/
performance checks. If there is something wrong with the
instrument, contact your Nihon Kohden representative for repair.
Environmental Safeguards
Depending on the local laws in your community, it may be illegal to
dispose of the lithium battery in the regular waste collection. Check
with your local officials for proper disposal procedures.
Disinfection and cleaning
To disinfect the outside surface of the instrument, wipe it with a nonabrasive cloth moistened with alcohol. Do not use any other
disinfectants or ultraviolet rays to disinfect the instrument.
1.2 Service Manual ECG-9620
1. GENERAL
Caution - continued
Transport
• Use the specified shipment container and packing material to
transport the instrument. If necessary, double pack the instrument.
Also, put the instrument into the shipment container after pac king so
that the buffer material does not get inside the instrument.
• When transporting a board or unit of the instrument, be sure to put it
in a conductive bag. Ne ver use an aluminum bag to transport a
board or unit. Also, never use a styrene foam or plastic bag which
generates static electricity to wrap the board or unit of the
instrument.
Handling the instrument
• Because the outside surface of the instrument is made of resin, the
outside surface of the instrument is easily damaged. So when
handling the instrument, remo ve clutter from around the instrument
and be careful to not damage the instrument or get it dirty.
• Because most of the boards in the instrument are multilayer boards
with surface mount electrical devices (SMD), a special tool is
required to remove and solder the electrical devices on it. To avoid
damaging other electrical components, do not remo ve and solder
SMD components yourself.
Measuring and Test Equipment
Maintain the accuracy of the measuring and test equipment by
checking and calibrating it according to the chec k and calibration
procedures.
Service Manual ECG-9620 1.3
1. GENERAL
Service Policy, Service Pa rts and P atient Safety Checks
Service Policy Our technical service policy for this instrument is to replace the faulty unit, board
or part or damaged mechanical part with a new one. Do not perform electrical
device or component level repair of the multilayer board or unit. We do not support
component level repair outside the factory for the following reasons:
• Most of the boards are multilayer boards with surface mount electrical
devices, so the mounting density of the board is too high.
• A special tool or high degree of repair skill is required to repair the multilayer
boards with surface mount electrical devices.
Only disassemble the instrument or replace a board or unit in an environment
where the instrument is protected against static electricity.
Service Parts
Refer to “Replaceable Parts List” of this manual for the service parts for technical
service that we provide.
NOTE
When ordering parts or accessories from your Nihon Kohden
representative, please quote the NK code number and part name
which is listed in this service manual, and the name or model of the
unit in which the required part is located. This will help us to
promptly attend to your needs. Always use parts and accessories
recommended or supplied by Nihon Kohden Corporation to assure
maximum performance from your instrument.
1.4 Service Manual ECG-9620
1. GENERAL
Patient Safety Checks
Maintenance Equipments
and T ools
Periodic maintenance procedures and diagnostic check procedures are provided in
this manual to ensure that the instrument is operating in accordance with its design
and production specifications. To verify that the instrument is working in a safe
manner with regard to patient safety, patient safety checks should be performed on
the instrument before it is first installed, periodically after installation, and after any
repair is made on the instrument.
For patient safety checks, perform the following checks as described in the
IEC60601-1 “Medical electrical equipment - Part 1: General requirements for
safety”:
• Protective earth resistance check
• Earth leakage current check
• Enclosure leakage current check
• Patient leakage current check
• Withstanding voltage check
Test equipment
When repairing or calibrating the instrument, the following test equipment is
required.
• Oscilloscope: 2 channels or more for input signal, 50 mV to 5 V input range, 1/
10 attenuating probe and 100 MHz or more frequency response characteristic
must be provided.
• Digital voltmeter: standard type (An oscilloscope can be used instead of the
digital voltmeter.)
Service Manual ECG-9620 1.5
1. GENERAL
General Safety Information
• Never use this cardiograph in the presence of any flammab le
• Never use this cardiograph in a high-pressure oxygen medical tank.
Using with an electrical surgical unit (ESU)
• Never use this cardiograph near an ESU. The cardiograph may
• When using this cardiograph with an ESU, refer to the instruction
DANGER
anesthetic gas or high-concentration oxygen atmosphere. Failure to
follow this warning may cause e xplosion or fire.
Failure to follow this warning may cause explosion or fire.
WARNING
malfunction due to high-frequency noise from the ESU.
manual for the ESU. Before measurement, check that the return
plate is correctly attached to the patient and check that the
cardiograph operates correctly when using with the ESU. If the
return plate is not attached correctly, it may burn the patient’s skin
where the electrodes are attached.
MRI examination
• Do not install this cardiograph in an MRI examination room. The
cardiograph may not operate properly due to high-frequency
magnetic noise from the MRI.
• When performing MRI tests, remo ve from the patient all electrodes
which are connected to this cardiograph. Failure to follow this
warning may cause serious electrical burn on the patient due to local
heating caused by dielectric electromotive force. For details, refer to
the instruction manual for the MRI.
When performing defibrillation
• Before defibrillation, remo ve all electrodes and gel from the chest of
the patient. If the defibrillator paddle touches electrodes or gel, the
discharged energy may burn the patient’s skin.
• Before defibrillation, all persons must keep clear of the bed and must
not touch the patient or any equipment connected to the patient.
Failure to follow this warning may cause serious electrical burn,
shock or other injury.
1.6 Service Manual ECG-9620
1. GENERAL
Warning - continued
Use only the following specified patient cables when using with a
defibrillator or ESU. When the specified patient cable is connected,
the cardiograph is type CF defibrillation-proof compliance. Failure to
follow this warning will cause serious electrical burn where the
electrode is attached and damage the cardiograph due to discharge
energy when defibrillation is performed.
Patient cable: BJ-901D – IEC standard, 3 mm diameter tip
BJ-902D – IEC/DIN standard, 4 mm diameter tip
BJ-903D – IEC/DIN standard, c lip
BA-901D – AHA requirement, 3 mm diameter tip
BA-903D – AHA requirement, color clip
When using an ESU and defibrillator with the cardiograph, use silver
chloride disposable electrodes.
Installation
WARNING
• Only use the 3-prong power cord provided with the cardiograph.
Failure to follow this caution may cause electrical shock to the
patient and operator.
• Only use the specified patient cable and connect the external
instruments with the specified installation procedure. Failure to
follow this warning may cause a serious electrical shoc k to the
patient and operator by leakage current.
CAUTION
• When the provided 3-prong power cord cannot be used, operate the
cardiograph on battery power. When another type of power cord
(especially 2-prong power cord) is used, this may cause electrical
shock to the patient and operator.
• When several medical instruments are used together, ground all
instruments at the same one-point ground to protect the patient and
operator from electrical shock. Any potential difference between
instruments may cause electrical shock to the patient and operator.
• When connecting an external instrument to connectors marked with
, the external instrument and this cardiograph must be connected
according to the IEC60601-1-1 “Medical electrical equipment - Part 11: General requirements for safety - Collateral standard: Safety
requirements for medical electrical systems”. Failure to follow this
warning may cause electrical shock to the patient and operator.
• When inserting or removing the battery from the cardiograph, make
sure that the cardiograph is turned off. Otherwise, the patient and
operator may get an electrical shock.
Service Manual ECG-9620 1.7
1. GENERAL
Battery Pack
DANGER
• Keep the battery pack awa y from fire. Do not heat the battery pack.
Otherwise, the substance liquid leaks out and the battery pack
explodes.
• Never short-circuit the + and – terminals on the battery pack with a
wire. Never store or carry the battery pack with metal such as
necklace or hair pins. The battery pack short-circuits and a large
current flows, causing leakage of the substance liquid inside the
battery and battery explosion.
• Never disassemble or modify the battery pack. Never damage or
directly solder the sheath tube. The battery pack short-circuits, the
substance liquid comes out and the battery pack explodes.
• Do not use a battery pack which is damaged, such as from falling.
There is a gas discharge valve inside the battery and if this valve is
damaged, the gas cannot be dischar ged, causing the battery pack to
explode.
• Do not subject the battery pack to a strong mechanical shock. The
susbstance liquid inside the battery leaks and explodes.
• If the battery pack is damaged and substance liquid inside the
battery contacts the eyes or skin, wash immediately and thoroughly
with water and see your physician. Never rub your eyes, otherwise
you may lose your eyesight.
• Only charge the battery pack with the ECG-9620 cardiograph. If any
other battery charger is used, abnormal current flows and the
substance liquid inside the battery leaks and the battery explodes.
• Do not connect the battery pack to an AC outlet or lighter socket in a
car. The substance liquid inside the battery leaks out and the battery
pack explodes.
• The battery has + and – polarity. Make sure that the battery is
installed with the correct polarity direction. Otherwise, the
substance inside the battery leaks out and the battery pack explodes.
• Use only the SB-901D battery pack.
WARNING
• Do not immerse the battery pack in water or seawater. The battery
heats up and rusts and the substance liquid inside the battery leaks.
• Never use a battery pack which is damaged, discolored or has
leakage. A damaged battery pack explodes if used.
• Do not leave the battery pack unused for more than one year. The
battery may leak.
1.8 Service Manual ECG-9620
1. GENERAL
CAUTION
• Do not charge the deteriorated battery pack. Otherwise, the
cardiograph cannot operate on battery power.
• Do not expose the battery pack to direct sunlight or leave in a high
temperature place. The life time of the battery pack may be
shortened, the performance of the battery pack may be degraded and
the substance liquid inside the battery may leak.
• Do not leave the battery pack where patients can reach it.
• Before disposing of the battery pack, c heck with your local solid
waste officials for details in your area for rec ycling options or proper
disposal. The battery is recyc lable. At the end of its useful life, under
various state and local laws, it may be illegal to dispose of this
battery into the municipal waste stream.
Operation
CAUTION
• Enter the patient information correctly. Otherwise, the ECG data may
be lost or mixed up with another patient’s ECG data.
ECG recording judgement
• The cardiograph provides automatic ECG analysis function. The
automatic ECG analysis is performed for acquired ECG waveforms
only and does not reflect all conditions of the patient. The results of
the analysis may not correspond to the judgment of a physician.
• Overall judgement must be performed by the ph ysician, referring to
the analysis result, c linical findings, and other examination results.
After the physician’ s overall judgement, the analysis results should
be signed or initialed by the physician.
• Take care when judging the ECG recording because the 25 Hz EMG
filter may cause greater distortion of P-waves and QRS-waves
depending on the waveform shape. The characteristics of the EMG
filter are similar to a conventional analog filter.
• Do not use the output signal from the output connector for a
synchronization signal such as the synchr onized cardioversion
signal. There is a time delay between the input ECG signal and
output signal.
• When the cardiograph operates on battery power and large leakage
current is input from the connected external instrument, ground the
cardiograph or use an isolation transformer for the external
instrument. Failure to follow this caution may cause electrical shock
to patient and operator.
• Use only the KD-103E cart for the cardiograph. When another cart is
used, the cardiograph may fall off or the cart may tip over.
Service Manual ECG-9620 1.9
1. GENERAL
Maintenance
Caution - continued
• Never use the cardiograph with its side panel downward. Failure to
follow this caution may cause the cardiograph to fall over or cause
battery liquid leakage.
NOTE
• When using the battery pack and the battery operation lamp is
blinking in orange, measurement results may not be saved.
CAUTION
• Before maintenance (cleaning, disinfection), make sure that the
cardiograph is turned off and the power cord is removed from the AC
outlet and cardiograph. Otherwise, the operator may get an electrical
shock and the cardiograph may malfunction.
• Before battery replacement, make sure that the cardiograph is turned
off and the power cord is removed from the AC outlet and
cardiograph. Otherwise, the operator may get an electrical shock.
• Do not disassemble or repair the cardiograph. Disassembly and
repair must be performed b y qualified service personnel.
1.10 Service Manual ECG-9620
Specifications
ECG input
Input impedance 10 MΩ or more
Electrode offset tolerance ±500 mV or more
Input unit protection Isolated and defibrillator protected only when the following specified patient
Standard sensitivity 10 mm /mV ±2%
Common mode rejection ratio 100 dB or more
Frequency response 0.05 to 150 Hz – 3 dB or more
Waveform data processor
Sample rate 500 samples/s (input unit: 8,000 samples/s)
AC line filter 50/60 Hz
High-cut filter 75, 100, 150 Hz
EMG filter 25/35 Hz
Time constant 3.2 s or more
Waveform status detection Electrode detachment (polarization voltage),
Sensitivity selection 5, 10 , 20 mm/mV
1. GENERAL
cable is connected
Patient cable: BJ-901D, BJ-902D, BJ-903D, BA-901D, BA-903D
Noise (high frequency)
LCD
Size 3.8 inch
Number of dots 320 × 240
ECG waveform 6 channel: 2.8 s
Displayed data Waveform, patient information, recording settings, operation mode, heart rate,
QRS sync mark, error message, electrode detachment, noise
Recorder
Printing method High resolution thermal printer head
Printing density 200 dpi (8 dots/mm)
Scanning line density 1 ms
Recording width 56 mm
Number of recording channels 1, 2, 3
Paper speed 25, 50 mm/s
Number of recording lines Up to 14
Printed data Program type, version, date and time, paper speed, sensitivity, lead name, filter,
Patient information (ID number, sex, age zone), timing mark, event mark,
electrode detachment, noise
Mechanical noise 48 dB or less at paper speed 25 mm/s
External input/output
External input 10 mm/0.5 V ±5%, input impedance 100 kΩ or more
Signal output 0.5 V/1 mV ±5%, output impedance 100 Ω or less
Serial I/O Communication method: RS-232C
Baud rate: 2400, 4800, 9600, 19200, 38400,
57600, 115200
Service Manual ECG-9620 1.11
1. GENERAL
Power requirement
Line voltage ECG-9620L: 220 V AC ±10%
Line frequency 50 or 60 Hz
Power input 45 VA
Power consumption 45 W or less
Built-in battery (SB-901D) Voltage: 12 V
ECG-9620M: 230 V AC ±10%
ECG-9620N: 240 V AC ±10%
ECG-9620P: 220 V AC ±10%
ECG-9620S: 110 V AC ±10%
ECG-9620T: 120 V AC ±10%
ECG-9620U: 127 V AC ±10%
Current consumption: 6 A or less
Battery operation time: 2 hours or more (when using a new fully charged
battery in manual mode, at 25 mm/s of recording
speed, 3 ch, and in continuous recording.)
Remaining battery power can change depending on
the surrounding temperature and quality of
recording waveform.
Environment
Operating temperature 5 to 40°C (41 to 104°F)
Operating humidity
25 to 85% RH (with battery pack and recording paper)
20 to 85% RH (with battery pack and without recording paper)
25 to 90% RH (with recording paper and without battery pack)
25 to 95% RH (without battery pack and recording paper)
Operating atmospheric pressure 70 to 106 kPa
Storage temperature
Cardiograph: -20 to 65°C (−4 to 149°F)
Battery pack: -20 to 50°C (−4 to 122°F) (within 30 days)
Recording paper: -20 to 50°C (−4 to 122°F)
Storage humidity
Cardiograph: 10 to 95% RH (non-condensing)
Battery pack: 10 to 85% RH (non-condensing) (within 60 days)
Recording paper: 10 to 90% RH (non-condensing)
Storage atmospheric pressure 70 to 106 kPa
-20 to 40°C (−4 to 104°F) (within 90 days)
-20 to 30°C (−4 to 86°F) (within one year)
45 to 85% RH (non-condensing) (more than 60 days)
Electromagnetic compatibility
IEC60601-1-2 (1993), CISPR11 (1990) Group 1 Class B
IEC60601-2-25 Amendment 1 (1999), protection against electrosurgery interference
Other
Indoor portable
1.12 Service Manual ECG-9620
Dimensions and weight
Dimensions 280 W × 70 H × 216 D mm (excluding protrusions)
Weight Approx. 3.1 kg (with battery)
Approx. 2.7 kg (without battery)
Safety
Safety standard:
IEC60601-1 (1998)
IEC60601-1 Amendment 1 (1991)
IEC60601-1 Amendment 2 (1995)
IEC60601-2-25 (1993)
IEC60601-2-25 Amendment 1 (1999)
Type of protection against electric shock:
AC power: Class I
Battery power: Internally powered equipment
Degree of protection against electric shock:
Defibrillator proof type CF applied part when patient cable BJ-901D, BJ-902D, BJ-903D, BA-901D or
BA-903D is used
Degree of protection against harmful ingress of water:
Ordinary equipment
Degree of safety of application in the presence of a flammable anaesthetic mixture with air, oxygen or nitrous
oxide:
Not suitable for use in the presence of a flammable anaesthetic mixture with air, oxygen or
nitrous oxide
Mode of operation:
Continuous
1. GENERAL
Service Manual ECG-9620 1.13
1. GENERAL
Panel Descriptions
Front Panel
2
3
1
Name
1. Operation panel
2. Magazine (paper container)
3. LCD screen
Left Side Panel
1
Name
1. Magazine release button
2. Patient cable connector
2
1.14 Service Manual ECG-9620
Operation Panel
1. GENERAL
7
8
3
1
2
4
5
6
11
12
13
9
10
14
Name
1. AC power lamp
2. Battery operation lamp
3. Battery charge lamp
4. Power key/lamp
5. Mode key
6 Rhythm key/lamp
7. F1, F2, F3 function keys
Name
8. Age key
9. Sex key
10. Auto/Manual key/lamp
11. Feed/Mark key
12. Filter key/lamp
13. Copy/CAL key lamp
14. Start/Stop key/lamp
Right Side Panel
CAUTION
• When connecting an external instrument to connectors marked with , the external instrument and this
cardiograph must be connected according to the IEC60601-1-1 “Medical electrical equipment - Part 1-1:
General requirements for safety - Collateral standard: Safety requirements for medical electrical
systems”. Failure to follow this warning may cause electrical shock to the patient and operator.
• Do not use the output signal from the output connector for a synchronization signal such as the
synchronized cardioversion signal. There is a time delay between the input ECG signal and output
signal.
2
1
Name
1. EXT-IN connector
2. CRO-OUT
3. SIO connector
4. AC power cord socket
5. Equipotential ground terminal
Service Manual ECG-9620 1.15
3
4
5
1. GENERAL
Rear Panel
The CE mark is applied only to the
ECG-9620L/M/N Electrocardiograph.
Battery
CAUTION
Always install the battery even when the cardiograph operates on AC
power. Otherwise sudden power down occurs when any electrode is
detached during recording.
1.16 Service Manual ECG-9620
Composition
Standard Components
1. GENERAL
ECG-9620L
ECG-9620M
ECG-9620N
ECG-9620P
ECG-9620S
ECG-9620T
ECG-9620U
RHC-0004 Record Assy
RHC-00041 Motor Assy
UTC-0009 Paper senser board
UTC-0010 Motor sensor board
RHC-00042 Magazine Assy
RKC-0001 Transfer Assy (220 V) for L and P version
RKC-0002 Transfer Assy (230 V) for M version
RKC-0003 Transfer Assy (240 V) for N version
RKC-0004 Transfer Assy (110 V) for S version
RKC-0005 Transfer Assy (120 V) for T version
RKC-0006 Transfer Assy (127 V) for U version
UTC-0006 Key board
UTC-0007 ECG control board
Options
UTC-0008 Power board
KD-103E Cart
KH-801E Patient Cable Hanger
· To order a replacement assembly above, use the Code No.
· To order a replacement component inside an assembly, refer to “Section 7
Replaceablet Parts List”.
Service Manual ECG-9620 1.17
1. GENERAL
Location
Thermal Head Assy
Buzzer
Motor Assy
LCD
Ke y board
ECG control board
Transfer Assy
Power board
1.18 Service Manual ECG-9620
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