Service Manual Desfibrilator Nihon Kohden01
Service Manual Desfibrilator Nihon Kohden01
SERVICE MANUAL
TEC-7631C
TEC-7621E
TEC-7631E
TEC-7621K
TEC-7631K
TEC-7721E
TEC-7731E
TEC-7721K
TEC-7731K
DEFIBRILLATOR
TEC-7600/TEC-7700
0634-002039B
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CONTENTS
Contents
GENERAL HANDLING PRECAUTIONS ......................................................................... i
WARRANTY POLICY .................................................................................................... ii
Conventions Used in this Manual and Instrument ........................................................ iv
Dangers, Warnings, Cautions and Notes ............................................................ iv
Explanations of the Symbols in this Manual and Instrument ............................... v
TEC-7721/7731 Series
Before You Begin ............................................................................................................... 3.2.1
Warnings, Cautions and Notes ................................................................................ 3.2.1
Required Tools ......................................................................................................... 3.2.1
How to Troubleshoot .......................................................................................................... 3.2.1
Connection Diagram (TEC-7721/7731 Series Defibrillator) ................................................. 3.2.2
Removing the Battery Pack ................................................................................... 3.2.4
Removing the Lower Casing .............................................................................................. 3.2.4
Removing the Paddles ............................................................................................ 3.2.4
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.
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.
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.
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.
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.
CAUTION
United States law restricts this device to sale by or on the order of a physician.
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.
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.
In IEC 60601-1-2 Medical Electronic Equipment, Part 1: General Requirements for Safety, 2. Collateral Standard:
Electromagnetic compatibility-Requirements and test. Section 36. 202. 2 Radiated radio-frequency electromagnetic
fields, PATIENT COUPLED EQUIPMENT and/or SYSTEMS applicable IMMUNITY test methods are under consideration
at SC62A/WG13. The 3 V/m IMMUNITY level may be inappropriate especially when measuring SpO2 because
physiological signals can be much smaller than those induced by a 3 V/m electromagnetic field.
When measuring SpO2, various interference may produce false waveforms which look like pulse waveforms. SpO2
value and pulse rate may be measured from these false waveforms, causing the alarm to function improperly.
When installing the monitor, avoid locations where the monitor may receive strong electromagnetic interference
such as radio or TV stations, cellular phone or mobile two-way radios.
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.
Dangers, 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 the 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.
On main unit
Defibrillation-proof type BF
Alternating current
applied part
Charging Equipotential
IPX4 Complying with IEC60529 IPX4 IPX7 Complying with IEC60529 IPX7
Introduction
Cardi
oLife
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 needs to understand the operation of the instrument
in order to effectively use the information in the service manual.
Not Not
Noninvasive pacing Standard Standard
available available
CAUTIONS
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 clean the instrument before servicing it. When
servicing the instrument, wear rubber gloves to protect yourself from
infection.
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.
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 packing so
that the buffer material does not get into the inside of the instrument.
• When transporting a board or unit of the instrument, be sure to use a
conductive bag on. Never use an aluminum bag when transporting a
board or unit on which a lithium battery is mounted. Also, never use
a styrene foam or plastic bag which generates static electricity to wrap
the board or unit of the instrument.
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 mounted 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 mounted electrical devices.
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.
Patient Safety Checks 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
Maintenance Equipments
When repairing or calibrating the instrument, the following test equipment is
and Tools
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.
• Power supply
• Oscillator: standard type
• Digital voltmeter: standard type (An oscilloscope can be used instead of the
digital voltmeter.)
General
DANGER
• Never use the defibrillator in a flammable atmosphere (i.e. areas with
flammable anesthetics, concentrated oxygen, hyperbaric oxygen) or in
an environment in which an electrical arc could ignite an explosion.
Otherwise, the defibrillator will explode or fire.
• Never use the defibrillator in a high-pressure oxygen medical care
tank. Otherwise, the defibrillator will explode or fire.
WARNING
• The defibrillator generates high voltage. The defibrillator must only
be operated by trained and qualified medical personnel.
• Radiofrequency or Electromagnetic Field
Do not use any kind of non-essential non-patient care device within a
radius of 1 meter around the defibrillator. The use of non-essential
non-patient care devices that emit radiofrequency or electromagnetic
fields may interfere with the operation of the defibrillator by causing
noise on the ECG waveform or error messages. If a non-essential
non-patient care device is accidentally placed near the defibrillator,
quickly remove it.
• MRI examination
- Do not install this defibrillator in an MRI examination room. The
defibrillator may not operate properly due to high-frequency
magnetic noise from the MRI.
- When performing MRI tests, remove all electrodes and transducers
from the patient which are connected to this defibrillator. 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.
• Using with ESU
- When using this defibrillator with an ESU, the ESU return plate and
the electrodes for monitoring must be firmly attached to the patient.
If the return plate is not attached correctly, it may burn the patient’s
skin where the electrodes are attached. Refer to the instruction
manual for the ESU.
- When using an ESU, use this defibrillator only in the MONITOR
mode and use the ECG electrodes for monitoring. Do not monitor
ECG with disposable pads, external paddles or internal paddles.
Otherwise, high frequency energy from the ESU causes abnormal
current to flow in the patient and unexpected discharge. This causes
serious electrical burn, shock, or other injury and damages the
defibrillator.
WARNING continued
• Surrounding Conditions
Fluids such as Ringer’s saline solution and blood are excellent
electrical conductors; to avoid creating potentially dangerous
electrical paths, keep the defibrillator and the immediate area clean
and dry at all times.
CAUTION
• Install the defibrillator and ESU appropriately and perform
equipotential grounding. Otherwise, noise from the ESU may be
falsely recognized as QRS and ECG monitoring may not be performed
properly.
• Use only Nihon Kohden products and specified parts and accessories.
When other products, parts or accessories are used, the defibrillator
heats up and breaks down, and monitoring stops.
• Do not reuse disposable products.
Installation WARNING
• Connect only the specified instrument to the defibrillator by following
the specified procedure. Otherwise, electrical leakage current may
harm the patient and operator.
• Connect only the specified instruments to the connector or sockets
marked with by following the specified procedure. Otherwise,
electrical leakage current may harm the patient and operator.
• Only use the provided power cord. Using other power cords may
result in electrical shock or other injury to the patient and operator.
When the provided power cord cannot be used, operate the
defibrillator on battery power.
• For patient safety, equipotential grounding of all instruments must be
performed. Consult with a qualified biomedical engineer.
• Do not connect several grounding leads directly to the equipotential
terminal because the grounding lead may be disconnected from the
terminal.
CAUTION
• The defibrillator should only be connected to external equipment
which complies with the CISPR 11 Second Edition 1990-09, Group 1
and Class B standard.
• Use only the KD-022A cart for this defibrillator. If another cart is used,
the cart may tip over or the defibrillator may fall off.
Battery
DANGER
• Keep the battery pack away from fire. Do not heat the battery pack.
Otherwise, the electrolyte comes 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 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
electrolyte comes out and the battery pack explodes.
• Do not subject the battery pack to a strong mechanical shock. The
battery leaks and explodes.
• Do not use a battery 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 discharged, causing the battery to explode.
• If the battery pack is damaged and the substance inside the battery
(alkaline liquid) 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.
• The battery pack has + and – polarity. Make sure that the battery is
installed with the correct polarity direction. Otherwise, the substance
inside the battery leaks and the battery pack explodes.
• Do not charge the battery pack with an instrument other than this
defibrillator. With another instrument, abnormal current flows and the
substance 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 inside the battery leaks and the battery pack
explodes.
WARNING
• Check the battery performance once a month.
• When you start using a new battery pack, write down the date of
battery first use on the label on the battery pack.
• Replace the battery pack every one year.
• During the battery test, the defibrillator cannot perform defibrillation
or cardioversion with battery power. Use the defibrillator on AC
operation or use another defibrillator. If the battery is deteriorated or
is not charged enough, defibrillation or cardioversion cannot be
performed.
• Do not immerse the battery pack in water or seawater. The battery
heats up and rusts and the substance inside the battery leaks.
• Never use a battery pack which is damaged, discolored or has leakage.
A damaged battery explodes if used.WARNING continued
• Do not leave the battery unused for more than one year. The battery
may leak.
CAUTION
• When inserting or removing the battery, disconnect the power cord
from the defibrillator. Otherwise, the operator may get electrical
shock.
• To keep the battery fully charged, always keep the power cord
connected to the AC outlet even when the defibrillator is not used.
• Do not expose the battery pack to direct sunlight or leave in a high
temperature place. The lifetime of the battery pack may be shortened,
the performance of the battery may be degraded and the substance
inside the battery may leak.
• The battery pack must be inserted by a qualified service personnel.
• Keep the battery pack away from children.
• Before disposing of the battery, check with your local solid waste
officials for details in your area for recycling options or proper
disposal. The battery is recyclable. 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.
Disposable Pads
WARNING
• Failure to comply with the following warnings may cause serious skin
burn or insufficient energy discharge and pacing current to the heart.
- Do not reuse disposable pads. The pads are disposable.
- If the pad package is broken, dispose of the pads and do not use
them.
- Do not use the pads if they are past the expiration date on the
package.
- Use the disposable pads as soon as possible after removing them
from the package. Do not use a pad which is left for a long period of
time after being removed from the package.
- Do not use the disposable pads if the gel has become dry, or the gel
breaks down and releases water.
- Do not use the disposable pads if the color of the gel changes to
dark brown and dark brown gel is on the protective liner.
• If any pad or connector gets wet, replace it with a new one. If a wet
pad or connector is used, it may cause electrical shock.
• Replace the disposable pads after 1 hour pacing.
CAUTION
• When using the disposable pads for long term ECG monitoring,
replace them every 24 hours. Failure to follow this caution may cause
insufficient pacing current and insufficient energy discharge to the
heart.
• Do not attach a disposable pad over another pad. Failure to follow
this caution may cause serious skin burn.
• Do not put heavy objects on the disposable pads or bend the pads.
Otherwise the pads get damaged and deteriorated, resulting in skin
burn on the patient.
Defibrillation, General
Cardioversion and AED
WARNING
• Before defibrillation and cardioversion, make sure that no one is in
contact with either the patient or any metal part of any equipment or
cables which supports or is connected to the patient. Failure to follow
this warning causes serious electrical shock or injury.
• Before defibrillation and cardioversion, remove all electrodes, probes
and transducers connected to a connector without a “ ” or “ ”
mark from the patient. Otherwise the operator may get electrical
shock and the connected instrument may be damaged.
• Before defibrillation and cardioversion, move all electrodes and
medicine on the patient’s chest to positions where the defibrillator
paddle or disposable pad will not touch. If the defibrillator paddle or
disposable pad directly touches electrodes or medicine, it causes skin
burn on the electrode or medicine attachment site.
• Do not carry or move the defibrillator when the charged energy
remains in the defibrillator. If the defibrillator falls, it discharges
energy and can cause electrical shock.
• For this defibrillator, the CONTACT lamp on the STERNUM paddle
indicates skin-paddle contact impedance. If the yellow or orange lamp
lights, the defibrillator may cause serious electric burn on the
patient’s skin and poor energy discharge to the patient. In case of an
emergency, medical personnel should decide whether to execute
discharge immediately, regardless of the CONTACT lamp display, or
take action to make good contact before discharge.
• Pay careful attention to the energy selection when using the pediatric
electrode plates. Applying high energy with the pediatric electrode
plates can cause serious electrical burn because the electrode plates
are small.
• Use the ECG monitoring electrodes (disposable electrodes) to monitor
the ECG waveforms. Stable ECG cannot be acquired with the PADDLE
lead because it is difficult to hold the paddles stable. ECG acquired
from external paddles, internal paddles or disposable pads is unstable
after discharge because of high polarization voltage.
• Do not perform defibrillation or cardioversion in a wet place. Before
defibrillation or cardioversion, move the patient and defibrillator to a
dry place. Otherwise the operator may get electrical shock.
• Do not discharge near a person or object other than the patient or test
electrode plate or energy checker. It may cause electrical shock to the
person or object.
• Confirm that there is no artifact on the ECG. If there is artifact on the
ECG, signals other than ECG are misrecognized to be QRS and
accidental discharge may occur which is not synchronized with the
patient’s QRS wave.
WARNING continued
• Do not perform synchronized cardioversion with the PADDLE lead
unless it is absolutely necessary. In synchronized cardioversion with
the PADDLE lead, artifact may be misrecognized as QRS and
accidental discharge may occur which is not synchronized with the
patient’s QRS wave.
• Never select “TEST” for the ECG lead. “TEST” is for maintenance and
the waveform displayed on the screen is not the patient’s ECG. If
synchronized cardioversion is performed with the TEST lead,
accidental discharge occurs which is not synchronized with the
patient’s QRS wave and it may cause ventricular fibrillation.
• For safe synchronized cardioversion, a defibrillator discharge must
occur within 60 ms of the peak of the ECG’s R wave. The TEC-7600
detects the peak of the R wave and effects the discharge within 25 ms
of the detected peak of R wave. When an external instrument is used to
provide the ECG signal, it must amplify the ECG signal from the
patient 500-1000 times and output the amplified ECG signal to the
TEC-7600 within 35 ms of the peak of the R wave so that the overall
delay from the peak of the R wave to discharge does not exceed 60
ms. If these conditions are not met, the cardioversion may be
ineffective or may cause ventricular fibrillation.
• The apex-posterior placement is not suitable for ECG monitoring or
AED analysis.
• The anterior-posterior placement is not suitable for defibrillation,
cardioversion, ECG monitoring or AED analysis. Use this placement
only for pacing.
CAUTION
When performing synchronized cardioversion, confirm that the SYNC
lamp is lit before every discharge. If “Sync mode after CV” is set to
Defib on the System Setup-Configuration screen, the defibrillator
automatically turns to the asynchronous defibrillation mode.
WARNING
• Apply contact gel only to the electrode plates of the external paddles.
If contact gel gets on any other part of the defibrillator, it may cause
electrical shock to the operator.
• Do not apply contact gel by hand. Failure to follow this warning may
cause serious electrical burn, shock, or other injury.
WARNING continued
• Do not grasp the paddle handles with the wet hand or the hand with
contact gel attached. Failure to follow this warning may cause
electrical shock to the operator.
• Apply contact gel to the electrode plates of the external paddles.
Failure to apply contact gel causes serious skin burn.
• Do not touch the electrode plate or edge of the paddle. Failure to
follow this warning may cause serious electrical burn, shock, or other
injury.
• When charging or discharging, do not touch anything other than the
handles. Failure to follow this warning causes electrical shock to the
operator.
• Before discharging, confirm that the paddles are firmly pressed
against the chest wall. Failure to follow this warning causes serious
skin burn or poor energy discharge to the heart.
• Do not perform open discharge into the air. This may cause electrical
shock to the operator or damage the defibrillator.
• Do not discharge the energy if the paddles are shorted to each other
by contact gel. Failure to follow this warning causes serious electrical
burn and poor energy discharge to the heart.
CAUTION
• If the patient’s body is wet, thoroughly wipe the moisture off the skin
so that the paddles do not short to each other.
• Do not discharge when the paddles touch each other. This may
damage the defibrillator.
WARNING
• Do not attach pads on the papilla, electrodes or medicine on the
patient’s body. Failure to follow this warning causes serious skin
burn.
• Fit the pad closely to the body surface so that current flows uniformly
through the pad. Failure to follow this warning causes serious skin
burn or insufficient energy discharge to the heart.
• During charging or discharging, do not touch the pads or connectors.
Failure to follow this warning causes electrical shock to the operator.
• Before discharging, confirm that the pads are firmly applied to the
chest wall. Failure to follow this warning causes serious skin burn or
poor energy discharge to the heart.
WARNING continued
• Do not discharge if the pads overlap each other or if the pads are
shorted to each other by anything conductive such as contact gel.
Failure to follow this warning causes serious electrical burn and poor
energy discharge to the heart.
CAUTION
• When connecting the pad adaptor to the paddle connector, do not
bend or damage the connector pin. Otherwise energy cannot be
discharged to the pads.
• If the patient’s body is wet, thoroughly wipe the moisture off the skin
so that the pads do not short to each other.
WARNING
• Always sterilize the internal paddles before use. Failure to follow this
warning may cause serious infection.
• Pay careful attention to the energy selection when using internal
paddles. Applying high energy to the heart may cause cardiac muscle
necrosis. Low energy is recommended.
• During charging and discharging, grip the internal paddles between
the guard at the top of the handle and the cable. If you grip the handle
between the electrode and the guard, you may get an electrical shock.
• Before discharging, confirm that the paddles are firmly positioned
against the heart. Failure to follow this warning causes serious skin
burn or poor energy discharge to the heart.
• Do not perform open discharge into the air. This may cause electrical
shock to the operator or damage the defibrillator.
CAUTION
• Do not twist the internal paddle holding the electrode part or give
strong impact to the paddle. It damages the electrode part.
• When connecting the internal paddles to the paddle connector, do not
bend or damage the connector pin. Otherwise energy cannot be
discharged to the paddles.
• Do not discharge when the paddles touch each other. This may
damage the defibrillator.
AED
WARNING
• Do not attach pads on the papilla, electrodes or medicine on the
patient’s body. Failure to follow this warning causes serious skin
burn.
• Fit the pad closely to the body surface so that current flows uniformly
through the pad. Failure to follow this warning causes serious skin
burn or insufficient energy discharge to the heart.
• When you perform defibrillation in an ambulance, stop the car.
• During charging or discharging, do not touch the pads or connectors.
Failure to follow this warning cause electrical shock to the operator.
• Before discharging, confirm that the pads are firmly applied to the
chest wall. Failure to follow this warning causes serious skin burn or
poor energy discharge to the heart.
• Do not discharge if the pads overlap each other or if the pads are
shorted to each other by anything conductive such as contact gel.
Failure to follow this warning causes serious electrical burn and poor
energy discharge to the heart.
CAUTION
• Before AED analysis or defibrillation, confirm that the patient is
unconscious and has no respiration and no pulse.
• The ECG of a child or a patient with a implanted pacemaker cannot be
analyzed correctly. For these patients, follow the physician’s
instruction.
• During AED analysis, do not touch or move the patient, pad adaptor
and disposable pad cable. Stop the life saving treatment such as CPR.
Otherwise, correct analysis result cannot be obtained. If the ECG
baseline is wandering because of surrounding conditions,
measurement conditions or electrode conditions, remove the causes
before performing AED analysis.
• When connecting the pad adaptor to the paddle connector, do not
bend or damage the connector pin. Otherwise energy cannot be
discharged to the pads.
• If the patient’s body is wet, thoroughly wipe the moisture off the skin
so that the pads do not short to each other.
• Do not discharge when the paddles touch each other. This may
damage the defibrillator.
Pacing
WARNING
• Do not perform pacing while using an ESU. Before using an ESU, turn
the defibrillator power off and remove disposable pads from the
patient. Otherwise, high frequency energy from the ESU causes
abnormal current to flow in the patient and causes serious electrical
burn, shock, or other injury. It also damages the defibrillator.
• Always monitor the ECG waveform with the ECG connection cable and
ECG electrodes.
• Confirm that there is no artifact on the ECG. If there is artifact on the
ECG, signals other than ECG are misrecognized to be QRS and
correct pacing cannot be performed.
• Do not touch the patient during pacing. Failure to follow this warning
may cause electrical shock.
• During pacing, do not touch the pads or connectors. Failure to follow
this warning causes electrical shock to the operator.
• The pacing rate must be determined by qualified medical personnel
based on the heart rate of the patient in a normal state.
• The pacing current must only be increased by qualified medical
personnel decision.
• Keep the current intensity as low as possible to minimize pain and
discomfort to the patient.
• Failure to follow the following warnings causes serious skin burn.
- Do not attach the pads over ECG electrode.
- Do not attach pads on the papilla or medicine on the patient’s
body.
- Fit the pad closely to the body surface so that current flows
uniformly through the pad. This reduces the required pacing
current and pain and discomfort to the patient.
• The apex-posterior placement is not suitable for ECG monitoring or
AED analysis.
• The anterior-posterior placement is not suitable for defibrillation,
cardioversion, ECG monitoring or AED analysis. Use this placement
only for pacing.
• Never select “TEST”. “TEST” is for maintenance and the waveform
displayed on the screen is not the patient’s ECG. Failure to follow this
warning causes accidental pacing which is not synchronized with the
patient’s QRS wave.
• Do not change the sensitivity or ECG lead setting after pacing is
started. If one of these settings is changed, the pacing stops for 3
seconds. Failure to follow this warning may cause serious heart
attack.
• For 300 ms after the pacing pulse is output, no signal can be detected
as a QRS wave.
CAUTION
• Check that the pacing pulse is effectively working by observing ECG
on the screen.
• When connecting the pad adaptor to the paddle connector, do not
bend or damage the connector pin. Otherwise energy cannot be
discharged to the pads.
• If the patient’s body is wet, thoroughly wipe the moisture off the skin
so that the pads do not short to each other.
ECG Monitoring
WARNING
• When using a defibrillator together with the monitor, use Ag/AgCl
electrodes. Other types of electrodes, stainless steel in particular, will
adversely affect the ECG waveform by slowing the baseline recovery
on the monitor and result in no monitoring immediately following
defibrillation.
• False low heart rate indicators may occur with certain pacemakers
because of electrical overshoots.
• Keep pacemaker patients under close observation. The pacemaker
rate may be counted during cardiac arrest and certain arrhythmias. Do
not rely only on heart rate alarms and the displayed heart rate.
• The apex-posterior placement is not suitable for ECG monitoring or
AED analysis.
• The anterior-posterior placement is not suitable for defibrillation,
cardioversion, ECG monitoring or AED analysis. Use this placement
only for pacing.
• With the pacing pulse rejection ON, narrow width QRS of a premature
baby or infant cannot be detected correctly and the defibrillator may
miscount QRS. In this case, set the pacing pulse rejection to OFF.
• Turn the pacing pulse rejection to OFF when monitoring a child.
Otherwise child’s QRS may not be recognized.
CAUTION
• When the “Check ECG Electrodes” message is displayed, ECG cannot
be monitored and the ECG alarm does not function. Check the
electrode, ECG connection cable, electrode leads and connection
cable and if necessary, replace it with a new one.
• Turn the pacing pulse rejection to ON when monitoring a pacemaker
patient. Otherwise QRS and pacemaker spike may not be
distinguished and pacemaker failure may not be recognized.
SpO2
WARNING
• Measurement may be incorrect in the following cases.
· When the patient’s carboxyhemoglobin or methemoglobin increases
abnormally
· When dye is injected in the blood
· When using an electrical surgery unit
· During CPR
· When there is body movement
· When there is vibration
· When measuring at a site with venous pulse
· When the pulse wave is small (insufficient peripheral circulation)
· When using an IABP (intra-aortic balloon pump)
• When not monitoring SpO2, disconnect the SpO2 adapter cable from
the defibrillator. Otherwise, noise from the probe sensor may interfere
and incorrect data is displayed on the screen.
• When using a disposable probe, change the measuring site every 8
hours. The skin temperature may increase at the attached site by 2 or
3°C and cause a burn or pressure necrosis. When using the probe on
the following patients, take extreme care and change the measurement
site more frequently according to symptoms and degree.
· A patient with a fever
· A patient with a peripheral circulation insufficiency
· Neonate or low birth weight infant with delicate skin
• To avoid poor circulation, do not wrap the tape too tight when fixing
the probe with surgical tape. Check the blood circulation condition by
observing the skin color and congestion at the skin peripheral to the
probe attachment site. Even for short-term monitoring, there may be
burn or pressure necrosis from poor blood circulation, especially on
neonates or low birth weight infants whose skin is delicate. Accurate
measurement cannot be performed on a site with poor peripheral
circulation.
• When measuring SpO2 of a patient who is in a state of shock or in
CPR (cardiopulmonary resuscitation), the acquired SpO2 data may be
incorrect due to the patient’s body movement.
• Do not use the probe during MRI examination because it may cause
skin burn on the probe attachment area. For details, follow the MRI
operator’s manual.
CAUTION
• For long term monitoring, check the circulation condition by
observing the skin color of the measuring site. To avoid circulation
insufficiency and skin burn, change the measurement site every
specified hours. Refer to the operator’s manual of the probe.
CAUTION continued
• Do not pull or bend the probe cable, and do not let caster feet run over
the probe cable. Do not immerse the probe cable in chemical
solutions or water. Failure to follow these cautions may cause cable
discontinuity, short circuit, skin burn on the patient and incorrect
measurement data. Replace any broken probe with a new one.
• Under normal conditions, normal light has negligible effect on this
probe. However, when measuring under strong light (surgical light,
sunlight, etc.), cover the probe with a blanket or cloth. Otherwise,
measurement accuracy is affected.
• Turn off the power of cellular telephones, small wireless devices and
other devices which produce strong electromagnetic interference.
Otherwise, the waveforms and measurements are affected by
interference and the displayed data may be incorrect.
• Only use the specified probes. Otherwise SpO2 cannot be monitored
properly and instrument performance may be degraded.
• Do not use a probe which is past the expiration date on the package.
• Do not use a damaged or disassembled probe.
• Disposable probes are not sterilized.
• Use the disposable probe only once and for one patient only. Do not
reuse the disposable probe for another patient. It will cause cross
infection.
• When the attachment site is wet with blood or when the patient has
nail polish on, remove the dirt and nail polish before attaching the
probe. The transmitted light may decrease due to the blood or nail
polish and the measurement data may be incorrect.
• If the skin gets irritated or redness appears on the skin by the probe,
change the attachment site or stop using the probe.
• If the probe is attached to the same limb that is used for NIBP
measurement or an IBP catheter, the blood circulation at the
attachment site is affected and the measurement may not be correct.
Attach the probe to a limb where the blood circulation is not affected.
• If patient’s nail is long, cut it or attach the probe to another finger. The
probe cannot be attached properly to a finger with a long nail.
• Refer to the probe instruction manual for details.
• Be careful when removing the tape from neonatal skin.
• When removing a probe that is taped to the skin, do not pull the cable
part of the probe because this can damage the probe’s cable
connection.
• If the “Check SpO2 unit”, “Check SpO2 probe site”, “SpO2 probe not
working”, “SpO2 module not working” or “SpO2 measurement
unstable” message appears frequently even when the probe is
attached on a site with appropriate thickness, the probe is
deteriorated. Replace the probe with a new one.
• When error messages which indicate faulty probe or SpO2 adapter
appear, stop monitoring and replace the probe or SpO2 adapter with a
new one.
CAUTION continued
• Do not use the probe over its stated lifetime. Otherwise the SpO2
measurement accuracy cannot be guaranteed.
• Do not use disposable probes for other patients. If the probe is dirty
with blood or bodily fluids, replace it with a new one.
CO2
WARNING
• When performing defibrillation or cardioversion during CO2
monitoring with the CO2 sensor kit, remove the sensor from the
patient. When the sensor cannot be removed, do not touch the sensor
cable because the discharged energy may cause serious electrical
burn, shock or other injury.
• With the TG-901T3 CO2 sensor kit, measurements are based on the
assumption of no CO2 gas in the inspiration. The CO2 concentration in
the respiration is calculated by taking the CO2 concentration in the
inspiration as 0 mmHg. Therefore, measuring CO2 by connecting the
CO2 sensor kit to a patient under mouth-to-mouth respiration or to a
Jackson Rees circuit or Mapleson D circuit where CO2 gas may be
present during inspiration may result in the acquired data being lower
than the actual value.
• With the TG-901T3 CO2 sensor kit, the defibrillator cannot monitor CO2
of patients younger than 3 years old or weighing less than 10 kg (22
lbs).
• Before MRI examination, remove the CO2 sensor kit from the patient.
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 MRI operator’s manual.
CAUTION
• The measurement may be inaccurate when a patient with an extremely
high respiration rate or patient with irregular respiration is monitored.
Read the measured values carefully.
• Measured value may be incorrect when the operating temperature
changes greatly.
• When the “CO2 sensor not working” or “CO2 adapter abnormality”
message is displayed, check the CO2 sensor kit and replace it if
necessary. CO2 cannot be monitored while the message is displayed.
• Only use the specified parts.
• Obey the CAUTION label on the CO2 gas cylinder.
• After the lifetime of the CO2 gas cylinder expires, the measurement
accuracy cannot be guaranteed.
CAUTION
• The airway adapter is not sterilized and is disposable. It can only be
used once. Do not reuse it for another patient. Otherwise it causes
cross infection.
• Do not sterilize the airway adapter. Safety cannot be guaranteed if the
airway adapter is sterilized.
• Use the Nihon Kohden specified airway adapter.
• Secure the CO2 sensor cable to the respiration circuit so that it is
parallel to the floor. If the cable is perpendicular to the floor, water
droplets may get onto the transparent film of the airway adapter, and
affect the measurement accuracy.
• The transparent film of the airway adapter is coated with the anti-
fogging material to prevent the moisture of the expiration and
inspiration from making the inside of the airway adapter foggy. Under
the operating environment specified in the TG-901T3 CO2 sensor kit
specifications, the anti-fogging material works for about 24 hours.
When this transparent film becomes dirty or is damaged, CO2 cannot
be measured correctly. For the optimum performance of the anti-
fogging material and correct measurement, follow the instructions
below.
- Do not use the airway adapter more than 24 hours.
- Replace the airway adapter if blood, sputum or mucus adheres to
the transparent film of the airway adapter.
- Do not damage the transparent film, and do not let dust or
chemical solutions contact the transparent film. Do not touch the
transparent film with your fingers, do not wipe it, and do not wash
it with alcohol or other detergents.
• Replace the airway adapter with a new one every 24 hours. Using the
airway adapter for longer than 24 hours affects measurement accuracy.
• When the transparent film of the airway adapter becomes dirty, replace
the airway adapter with a new one instead of cleaning it. Attempting
to remove the stain, touching with fingers or washing with a cleaner
damages the transparent film and makes correct measurement
impossible.
Alarms
WARNING
All alarms except for instrument alarm group 1 are suspended during
two minutes alarm suspension.
CAUTION
• When the alarm limit is set to OFF, there will be no alarm for that limit.
Be careful when you set the alarm to OFF.
• Alarms about a parameter do not occur until the measurement of the
parameter starts.
Maintenance
WARNING
• When performing energy discharge test, discharge the energy with the
paddles kept in the paddle holders. Do not discharge with the paddle
released in the air or when the paddles are shorted. Failure to follow
this warning may cause serious electrical shock and damage to the
instrument.
• If defibrillation or cardioversion is necessary during battery test,
cancel the battery test and operate the defibrillator on AC power. Do
not use battery power because the battery may have been discharged
by the battery test.
CAUTION
• Before maintenance (cleaning, disinfection), turn the defibrillator
power off, disconnect the power cord from the AC outlet and then
remove the battery from the defibrillator. Failure to follow this caution
may result in electrical shock and instrument malfunction.
• Before battery replacement, turn off the defibrillator power and
disconnect the AC power cord from the defibrillator. Otherwise, the
operator may get an electrical shock.
• Do not disassemble or repair the instrument. Disassembly and repair
must be performed by qualified service personnel.
Storage
CAUTION
• To prevent overheating, leave the defibrillator lying flat and do not
cover it.
• Store the disposable pads in an environment described on the pads
package. If stored in an environment other than specified, the pads
become unusable.
Specifications
Defibrillator
TEC-7600 Series
Output energy (across 50 Ω) 2, 3, 5, 7, 10, 20, 30, 50, 70, 100, 150, 200, 300, and 360 J
Energy accuracy 2 J: ±0.5 J
3 J: ±1 J
5 to 10 J: ±2 J
20 to 360 J: ±10%
Output waveform Edmark, single phase pulse (across 50 Ω)
Charging time When powered by AC 100V to 240V:
to 360 J, maximum 5 s
to 200 J, maximum 3 s
When powered by 90% of the rated mains voltage:
to 360 J, maximum 5 s
When powered by a fully charged new battery at 20°C ambient temperature:
to 360 J, maximum 10 s
After 15 discharges at 360 J with a fully charged new battery at 20°C ambient
temperature: to 360J, maximum 10 s
Charging display Displays the charged energy value on the screen
Synchronized discharge Available
From the peak of R wave to the peak of discharge: within 60 ms
Maximum continuous charge/discharge cycles at 360 J
60 cycles: 3 cycles per minute with 1 minute cool down period after every 1
minute charge/discharge period
15 cycles: 3 cycles per minute with no cool down period
Current
(Amps)
81A
58A
Delivered energy= 360J
37A
0A
0 2 4 6 8 10 Time (ms)
TEC-7700 Seies
Output energy (across 50 Ω) 2, 3, 5, 7, 10, 15, 20, 30, 50, 70, 100, 150, 200 and 270 J
Energy accuracy 2 J: ±0.5 J
3 J: ±1 J
5 to 15 J: ±2 J
20 to 270 J: ±10%
Output waveform Biphasic, truncated exponential constant power (across 50 Ω)
Charging time When powered by AC 100V to 240V:
to 270 J, maximum 5 s
to 150 J, maximum 3 s
When powered by 90% of the rated mains voltage:
to 270 J, maximum 5 s
When powered by a fully charged new battery at 20°C ambient temperatur e:
to 270 J, maximum 10 s
After 15 discharges at 270 J with a fully charged new battery at 20°C ambient
temperature: to 270J, maximum 10 s
Charging display Displays the charged energy value on the screen
Synchronized discharge Available
From the peak of R wave to the peak of discharge: within 60 ms
Maximum continuous charge/discharge cycles at 270 J
60 cycles: 3 cycles per minute with 1 minute cool down period after every 1
minute charge/discharge period
15 cycles: 3 cycles per minute with no cool down period
Non Invasive Blood pressure, NIBP ((When optinal SG-761VC/VE/VK NIBP Unit is installed)
Display parameters: Systolic pressure, mean pressure, diastolic pressure, cuff pressure
Measuring range: 0 to 300 mmHg
Accuracy: ±3 mmHg (0 mmHg ≤ NIBP < 200 mmHg)
±4 mmHg (200 mmHg ≤ NIBP ≤ 300 mmHg)
Safety: Cuff inflation maximum pressure: Adult 300 to 330 mmHg
Neonate 150 to 165 mmHg
Cuff inflation time limiter: Adult ≤ 180 s
Neonates ≤ 90 s
When sudden power loss occurs, automatic rapid deflation is perofrmed.
Measurement mode: Manual
STAT (continuous)
Automatic (periodic)
Alarm: Adult
Upper limit range: 15 to 260 mmHg in 5 mmHg steps, OFF
Lower limit range: OFF, 10 to 255 mmHg in 5 mmHg steps
Neonate
Upper limit range: 10 to 125 mmHg in 5 mmHg steps, OFF
Lower limit range: OFF, 5 to 120 mmHg in 5 mmHg steps
Battery
Type Ni-MH battery
Nominal voltage: 12 V
Rated capacity: 2800 mAh
Capacity
TEC-7621/7631 series: With fully charged new battery at 20°C ambient temperature
- Minimum 70 discharges at 360 J
- Minimum 150 minutes continuous monitoring
- Minimum 90 minutes fixed mode pacing (180 pulse/min, 200 mA)
With the fully charged new battery at 0°C, the defibrillator can perform:
- Minimum 50 discharges at 360 J
TEC-7721/7731 series: With fully charged new battery at 20°C ambient temperature
- Minimum 100 discharges at 270 J
- Minimum 150 minutes continuous monitoring
- Minimum 90 minutes fixed mode pacing (180 pulse/min, 200 mA)
With the fully charged new battery at 0°C, the defibrillator can perform:
- Minimum 50 discharges at 270 J
Clock Accuracy
Service Manual TEC-7600/7700 1.25
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1. GENERAL
Environment
Operating temperature: 0 to 45°C (32 to 113°F)
Operating humidity: 0 to 40°C: 30 to 95% (relative humidity, non-condensing)
40 to 45°C: 30 to 80% (relative humidity, non-condensing)
Operating atmospheric pressure: 70 to 106 kPa
Electromagnetic Compatibility
IEC60601-1-2 (1993)
IEC61000-3-2 (1995)
Emissions: CISPR11 Group1,Class B
Safety
Safety standard IEC 60601-1 (1988)
IEC 60601-1 Amendment 1 (1991)
IEC 60601-1 Amendment 2 (1995)
IEC 60601-2-4 (1983)
IEC 60601-2-30 (1995)
According to the type of protection against electrical shock
Battery power: INTERNALLY POWERED EQUIPMENT
AC power: CLASS I EQUIPMENT
According to the degree of protection against electrical shock
DEFIBRILLATION-PROOF TYPE BF APPLIED PART:
External paddles, disposable pads, SpO2 adapter and CO2 sensor kit, NIBP cuff
DEFIBRILLATION-PROOF TYPE CF APPLIED PART:
Internal paddles, ECG connection cable
According to the degree of protection against harmful ingress of water: IPX1
According to the degree of safety of applicationin the presence of a FLAMMABLE ANAESTHETIC MIXTURE
WITH AIR, OR WITH OXYGEN OR NITROUS OXIDE:
EQUIPMENT not suitable for use in the presence of FLAMMABLE ANAESTHETIC MIXTURE WITH AIR,
OR WITH OXYGEN OR NITROUS OXIDE
Mode of operation
Continuous operation with intermittent load: Operation at defibrillation mode
Continuous operation: All operation except above mentioned
Monitor
Effective display area 115.2(W) × 86.4(H) mm (5.7 inch)
Sweep length 97 mm
Sweep speed 25 mm/s, 50 mm/s
Sensitivity 10 mm/1mV ±5% (sensitivity × 1)
Amplitude limit 40 mm
ECG Amplifier
1.26 Service Manual TEC-7600/7700
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1. GENERAL
Recorder
Paper speed Real time/delayed ECG waveform recording: 50, 25, 5 mm/s
Types of recording Manual recording:
real time/delayed waveform recording, report recording, event recording
Automatic recording:
record on charging after discharge, alarm recording, periodic recording
Power Requirements
AC
Line voltage: 100 to 240 V
Line frequency: 50/60 Hz (automatic switching)
Power input: Intermittent load: 450 VA or less
Continuous load: 200 VA or less
DC (Battery)
Power voltage: 12V
Power consumption Intermittent load, 14 A or less
Continuous load: 4.2 A or less
Charging time: 3 hours or less
Panel Description
Front Panel
TEC-7600 Series
7 1
CardioLife
PACING
PACING
DEMAND
DEMAND
DISARM
AED
FIXED
DISARM FIXED
SETUP
MONITOR
OFF
SYNC
3 AED
MONITOR
SETUP
CHARGE
AED OFF
SYNC
2 CHARGE
AED
5
8
DISCHARGE
10 4
9
6
TEC-7700 Series
7 1
CardioLife
PACING
PACING
DEMAND
DEMAND
DISARMS
AED
FIXED
DISARMS FIXED
SETUP
MONITOR
OFF AED
SETUP
SYNC MONITOR
CHARGE
AED
3 OFF
SYNC
2 CHARGE
AED
5
8
DISCHARGE
10 4
9
6
Name
1. Energy/Mode Select control
2. SYNC button
3. SYNC lamp
4. CHARGE/AED button
5. CHARGE button
6. DISCHARGE button
7. Screen
8. ECG input connector
9. SpO2/CO2 connector (on the optional QI-762V DSI Interface Unit)
10. Paddle connector
11 13 15 16 17 18 21 20 19
12 14
Name
11. Record key
12. Recording lamp
13. Event key
14. Event lamp
15. ECG lead key
16. ECG sensitivity key
17. SILENCE ALARM key
18. Alarm setting key
19. AC lamp
20. Battery charging lamp
21. Battery charge complete lamp
3 6
START
STOP
1 2 4 5
Name
1. PACING RATE control
2. PACING OUTPUT control
3. PACING lamp
4. START/STOP key
5. START/STOP lamp
6. PULSE lamp
External Paddles
4 1 2 3 4
Name
1. CONTACT lamp
2. CHARGE button
3. CHARGE lamp
4. DISCHARGE buttons
2 1
Name
1. Recording paper exit
2. Door release lever
3. Card slot
4. Card eject button
4 3
Rear Panel
3
1
2
Name
1. AC SOURCE socket
2. Equipotential ground terminal
3. Optional unit connector
Bottom Panel
Composition
Standard Components
WS-751X Recorder
WS-751X Recorder
WS-751X Recorder
WS-751X Recorder
KD-022A Cart
Board/Unit Location
AC/DC unit
HV coil
LCD unit
HV capacitor
Key board
Paddle connector
AC/DC unit
Pacer board
(TEC-7731 series only)
LCD unit
Biphasic HV unit
HV capacitor
Key board
Paddle connector
Block Diagram
How to Troubleshoot
Use this section to locate, identify and solve a problem in the instrument or an error
message displayed on the screen. The troubleshooting tables in this section are
divided into general problems and displayed error messages.
2. In the “Error Code”, “Message” or “Problem” column, find the trouble item
that matches the problem or error message.
3. Do the action recommended in the “Action” column. (Do the first action
recommended in the “Action” column).
4. If the problem or error message is not solved, do the next action recommended
in the “Action” column. (If this does not solve the problem, do the next
recommended sections.)
5. If none of the actions solve the problem, contact your Nihon Kohden
distributor or representative.
NOTE
Before contacting your NK distributor or representative for technical
support, please complete a copy of the Maintenance Check Sheet
(the original copy is provided at the end of the Section 4
“Maintenance”), and if possible, provide additional detailed
information on the problem. Send the complete copy of the
Maintenance Check Sheet to your NK distributor or representative.
This will allow your NK distributor or representative to provide you
with the best support.
Error Code
The instrument displays an error code if it detects an error when the power is
turned on and during operation.
NOTE
• For problems that are not reproducible, call up the System Setup
screen and print the REPORT HISTORY. Refer to the Operator's
Manual for the detail of this procedure. The error code will be lost
when the power is turned off.
• Always check all the cable connections in the instrument before
performing the action recommended in the troubleshooting tables in
this section. This is because a loose cable connection can cause the
instrument to display the error code.
Turn off the instrument, then turn on the instrument and do the same operation.
Yes
Refer to error code
description for detail.
Defibrillation
TEC-7621/7631 series
TEC-7721/7731 series