Super Unit HS-8000 Series Service Manual Edition 1 Aug 2011.pdf
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Super Unit
HS-8000 Series
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Service Manual
z Before setting up/maintenance, please read this “Service Manual” thoroughly.
z After reading, keep this manual for future use.
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Service manual Delivery Notice
Service Manual (No.
): Q’ty 1
Please confirm your receipt of the above service manual by filling in
and sending us back this sheet by return.
Delivery of Service Manual
Please note that this service manual is a confidential document and
needs to be kept with an utmost care under person in charge. If the
technical drawing in the service manual is unreadable, you can
request it to us by specifying a page or a part.
When you have received this service manual, verify that there is no
paging disorder or missing page. You are requested to kindly fill the
underlined area below in this sheet and send it back to us after
verification. Please be noted that photocopying of this manual is
strictly prohibited.
Also, for improvement of the future service manual, your comment
and request will be appreciated. If you have any comment or request
on usability, viewability, readability, or if you notice anything hard to
understand on this service manual, please inform it to us.
Fukuda Denshi Co., Ltd.
Development & Production Support Dept.
2-35-8 Hongo Bunkyo-ku, Tokyo, 113-8420 Japan
Received by
of (Company/Hospital)
on the day of
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Revision History
Model Name
HS-8000 Series
Edition
1
－
Service Manual
Revised Items
Reason of the Revision
New Edition
Revised Date
2011.8
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Blank Page
Page 5
Preface
Before using this product, read the following precautions to make sure the product is
used correctly and safely.
Safety Precautions·························································· ii
Graphic Symbols ·························································· ii
Precautions for Safe Operation of Medical Electrical
Equipment ··································································· iii
Precautions about the Maintenance ···························· iv
Precautions about the Pacemaker······························· iv
Non-Explosion Proof·····················································v
Defibrillation Safety·······················································v
Precautions about the Mason-Likar System ·················v
●ECG Recording by the Mason-Likar System·······v
●Electrode Placement ···········································v
Electrosurgery Safety ·················································· vi
Precautions about Magnetic Resonance Imaging ······· vi
Precautions about Connections to Peripheral Devicesvii
Accessories and Optional Accessories······················· vii
Precautions about the HS-8000 System···················· viii
Precautions for Use of SpO2 Sensor ··························· xi
Precautions about Masimo® SpO2 measurement unit
(HS-8312M) ································································ xii
Precautions for Use of NIBP Cuff ······························· xii
Disposing of Equipment, Accessories, or Componentsxii
Precautions about Transportation······························· xii
Precautions about RTC or Data Backup····················· xii
To Prepare for Emergency Use ·································· xii
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Safety Precautions
y Read the “Safety Precautions” thoroughly before use to ensure correct and safe use of the
product.
y Make sure to follow the precautions indicated below, as these are important messages related to
safety
Failure to follow this message may cause immediate threat of death or
D A N G E R serious injury, or complete failure of the equipment.
Failure to follow this message may result in death or serious injury, or
W A R N I N G complete failure of the equipment.
C A U T I O N Failure to follow this message may cause injury or failure to the equipment.
NOTE
A note is not related to product safety, but provides information about the correct use
and operating procedures to prevent incorrect operation and malfunction of the
equipment.
Graphic Symbols
Refer to the following for the meaning of the symbols indicated on the equipment.
Symbol used in the Unit
Symbol
Description
Caution; refer to accompanying documents
Indicates the need to refer to related accompanying documents before
operation.
Electrostatic Sensitive Part
Directly touching this connector part with hands should be avoided.
Type CF Applied Part with Defibrillation-Proof
Indicates the degree of protection against electric shock is Type CF
Applied Part with defibrillation-proof.
Type BF Applied Part with Defibrillation-Proof
Indicates the degree of protection against electric shock which is Type BF
Applied Part with defibrillation-proof.
Signal Output
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Precautions for Safe Operation of Medical Electrical Equipment
Read the following precautions thoroughly to correctly operate the device.
z Users should have a thorough knowledge of the operation before using
this system.
z Pay attention to the following when installing and storing the equipment.
y Do not install or store in an area where the equipment will be subject to
splashing water.
y Do not install or store in an area where the environmental conditions, such as
atmospheric pressure, temperature, humidity, ventilation, sunlight, dust, sodium,
sulfur, will adversely affect the system.
y Place the equipment on a stable surface where there is no inclination, vibration,
or shock (including during transportation).
y Do not install or store in an area where there are chemical or gasses stored.
z Before operating the system, verify the following items.
Verify the power voltage.
Check the cable connection to ensure proper operation of the unit.
Ensure that all cables are firmly and safely connected.
Pay special attention when the device is used in conjunction with other
equipment as it may cause erroneous judgment and danger.
y Ensure all patient connections are proper and secure.
y
y
y
y
CAUTION
z During operation of the system, verify the following items.
y Always observe the system and patient to ensure safe operation of the
equipment.
y If any abnormality is found on the equipment or patient, take appropriate
measures such as ceasing operation of the equipment in the safest way for the
patient.
y Do not allow the patient to come in contact with the device.
z After using the system, verify the following items.
y Unplug all the cables from the patient before turning off the power.
y When unplugging the cables, do not apply excessive force by pulling on the
cable. Pull by the connector part of the cable.
y Clean the accessories and cables, and keep them together in one place.
y Keep the unit clean to ensure proper operation of the next use.
z Do not remodel the equipment.
z Maintenance Check
y Make sure to periodically check the equipment, accessories and cables.
y Before reusing the device that has been left unused for a while, make sure that
the device works normally and safely.
z To prevent burn injury to the patient, verify proper attachment of patient
ground plate or ECG electrode type when using the electrosurgical knife,
and verify paste volume or output energy when using the defibrillator. Also,
verify that proper ground is selected.
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Precautions about the Maintenance
Safety Inspection and Maintenance
For safe operation of the equipment, regular inspection and maintenance is required. Once a year,
check all cables, devices, and accessories for damage, earth impedance, earth and leakage
currents, and all alarm functions. Also, ensure that all safety labels are legible. Maintain a record of
these safety inspections.
Immediate maintenance has to be carried out if ;
y the equipment was subjected to extreme mechanical stress, e.g. after a heavy fall.
y the equipment was subjected to liquid spill.
y the monitoring function is interrupted or disturbed.
y parts of the equipment enclosure are cracked, removed, or lost.
y any connector or cable shows signs of deterioration.
Reference
Refer to “12. Periodic Check” for details.
Never open the housing while the equipment is in operation or connected to
W A R N I N G hospital grade outlet as it may result in electric shock.
Maintenance, Modifications, and Repairs
Fukuda Denshi is liable for the safety, reliability, and performance of its equipment only if;
y Maintenance, modifications, and repairs are carried out by authorized personnel.
y Components are used in accordance with Fukuda Denshi operating instructions.
Precautions about the Pacemaker
z Minute ventilation rate-adaptive implantable pacemakers can occasionally
interact with the bedside monitor including this unit and diagnostic
equipment, causing the pacemakers to pace at their maximum
programmed rate. The cardiac monitoring and diagnostic equipment may
possibly send wrong information.
If such event occurs, please disconnect the cardiac monitoring and
diagnostic equipment, or follow the procedures described in the operation
manual of the pacemaker.
Reference “Minute Ventilation Rate-Adaptive Pacemakers”
FDA alerts health professionals that minute ventilation rate-adaptive
WARNING
implantable pacemakers can occasionally interact with certain cardiac
monitoring and diagnostic equipment, causing pacemakers to pace at their
maximum programmed rate.
[October 14, 1998 (Letter: www.fda.gov/cdrh/safety.html) – FDA]
z Rate meters may continue to count the pacemaker rate during
occurrences of cardiac arrest or some arrhythmias. Do not rely entirely
upon rate meter alarms. Keep pacemaker patients under close
surveillance. See this manual for disclosure of the pacemaker pulse
rejection capability of this equipment.
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Non-Explosion Proof
Never operate the equipment in the presence of flammable anesthetics, high
of oxygen, or inside hyperbaric chamber. Also, do not operate
D A N G E R concentration
the equipment in an environment in which there is a risk of explosion.
Explosion or fire may result.
Defibrillation Safety
z When defibrillating, keep away from the electrodes or medicament applied
to the patient chest. If this is not possible, remove the electrodes or
medicament before defibrillating.
If the defibrillator paddles directly contact the electrodes or medicament, electrical
shock may result by the discharged energy.
W A R N I N G z When defibrillating, make sure that the electrodes, sensor cables, or relay
cables are firmly connected to the device.
Contacting the metal part of the disconnected cable may result in electrical shock
by the discharged energy.
z When defibrillating, do not touch the patient and the metal part of the
device or cables. Electric shock may result by the discharged energy.
Precautions about the Mason-Likar System
●ECG Recording by the Mason-Likar System
The 12-lead ECG recorded with the torso placement of the limb leads
(Mason-Likar 12-lead system) may differ from the standard 12-lead ECG.
Moreover, waveforms may differ somewhat also in a supine position and a
C A U T I O N standing position (sitting position). We recommend to carry out the recording of
the ECG by taking into consideration the waveform differences according to
electrode positions or postures.
●Electrode Placement
NOTE
To reduce the waveform differences from the standard 12-lead, we recommend that
the torso placement of the R and L electrodes be near as possible to each arm, in
the infraclavicular fossae, within the area unaffected by myoelectricity.
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Electrosurgery Safety
The monitoring system contains protection against interference generated by
electrosurgical instruments. However, operating conditions, surgery site with
respect to the location of ECG electrodes, or the type of instrument used,
may cause noise on the ECG. The noise is generated at the tip of an
electrical knife and is difficult to completely eliminate because of the
frequency components of the ECG. To reduce electrosurgical interference,
take the following precautions:
Location
Locate the electrosurgical unit as far as possible from this unit and the patient
cable. This will help reduce interference on the ECG through the monitor or
cables.
WARNING
Power Supply
Connect the electrosurgical unit to a power supply that is different from that of the
monitor. This will help prevent interference through the power cable.
Electrode Placement
The amount of interference is considerably different depending on the electrode
position and surgery site. Place the ECG electrodes as far away as possible from
the surgery site. Do not place electrodes in the path between the surgery site and
the ground plate. If the electrodes are placed in this path, the amount of
interference will be quite large. Position (+) and (–) electrodes as close as
possible to each other.
Ground Plate
When using electrosurgical instruments, make sure the contact between the
patient and the ground plate is secure. If the connection is incomplete, the patient
may suffer a burn at the electrode site.
Precautions about Magnetic Resonance Imaging
z Do not operate this equipment in magnetic resonance imaging (MRI)
environments.
z When conducting MRI test, remove the electrodes and sensors connected
WARNING
to the patient (test subject).
The local heating caused by the induced electromotive force may cause burn
injury to the patient (subject). For details, refer to the operation manual for the
MRI testing device.
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Precautions about Connections to Peripheral Devices
In the interest of safe and sufficient performance of this equipment, the connection of other
manufacturers’ equipment to the monitor is not authorized, unless the connection is explicitly
approved by Fukuda Denshi. It is the user’s responsibility to contact Fukuda Denshi to determine
the compatibility and warranty status of any connection made to another manufacturer’s
equipment.
For the connector with
mark, only the peripheral devices specified by
Fukuda
Denshi
should
be
connected
with the given procedure. Use of an
WARNING
unspecified device may cause electric shock to the patient and/or operator
due to excessive leakage current.
z For safety reasons, the peripheral device connector on this unit (analog
output connector) is insulated from the circuit applied to the patient.
z The circuit connected to this unit on the peripheral side is not necessarily
CAUTION
insulated. Therefore, since touching the peripheral directly may result in
electric shock to the patient, always position the peripheral away from the
patient.
When connecting peripheral devices to this unit, it is the user’s responsibility to verify that the
overall system complies with IEC 60601-1-1, “Collateral Standard: Safety Requirements for
Medical Electrical Systems”.
Accessories and Optional Accessories
Use only the cables specified by Fukuda Denshi.
WARNING
y Use of other cables may result in increase in emission (unnecessary generation
of electromagnetic energy from this unit) or decrease in immunity (resistance
characteristics to electromagnetic interference generating from other device).
y We cannot assure the performance of this unit when other cables are used.
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Precautions about the HS-8000 System
Be careful when connecting to other device.
D A N G E R Danger such as electric shock may result to the patient and operator.
z Do not connect unit or cable not authorized by Fukuda Denshi to any I/O
connector. If done so by mistake, the HS-8000 system cannot deliver its
maximum performance and the connected units may be damaged,
resulting in a safety hazard.
z If this unit is used under the condition where operating environment is not
satisfied, this unit can neither deliver its maximum performance nor ensure
safety such as damage to this unit.
z Objective and constant arrhythmia detection is possible through the fixed
algorithm incorporated in this monitor.
However, excessive waveform morphology change, motion artifact, or the
inability to determine the waveform pattern may cause an error, or fail to
make adequate detection. Therefore, physicians should make final
decisions using manual recording, alarm recording and recall waveform
for evaluation.
z Be careful when setting the "SpO2 Averaging" duration as the SpO2 alarm
is based on the displayed SpO2 value which is averaged from the duration
set in "SpO2 Averaging". The alarm occurrence time will be affected or
may not occur for the transient value of SpO2 depending on the set
duration.
z When measuring the SpO2 of patient with high fever or peripheral
circulatory insufficiency, check the sensor attachment periodically and
change the attachment site. The temperature of attachment site will rise 2
to 3°C due to the sensor heat which may result in burn injury.
z For the following case, accurate measurement may not be possible.
WARNING
Patient with excessive abnormal hemoglobin (COHb, MetHb)
Patient with the pigment injected to the blood
Patient receiving CPR treatment
When a sensor is applied to a limb with NIBP cuff, arterial catheter, or
intracatheter
y When measuring at site with venous pulse
y Patient with body motion
y Patient with small pulse
y
y
y
y
z Before the Non-Invasive Blood Pressure measurement, make sure the
patient classification ( Adult ・ Child ・ Neonate) is properly selected on
the Patient Admit display in the main unit. Otherwise, correct
measurement cannot be performed, and injury such as congestion may
result.
z Always consider the circumference of the intubation tube when using the
airway adapter. If inappropriate airway adapter is used for a patient with
low ventilation, CO2 may mix in to the inspired air resulting in incorrect
measurement, or apnea detection may become difficult.
z The analog signal has a delay output according to the filter mode setting
on the main unit. (For ECG, the delay is approximately 15 to 35 msec, and
in BP, approximately 35 to 50 msec.) When connecting to any equipment
that uses a vital signal as a trigger signal, for instance, IABP, make sure
that the filter selection and delay time of the HS-8000 series meet the
specification of such equipment.
z The delay time varies depending on the types of waveform, or caused
interference.
z The QRS SYNC signal has a delay output (the delay time is less than 100
ms). The delay time varies depending on the filter mode setting on the
main unit or type of the waveform input.
z When the QRS SYNC signal is input to any external devices, make sure
that the delay time of the HS-8000 series is within the acceptable range of
such device.
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z HS-8000 System
y Use only the accessories specified for this unit. Otherwise, proper function
cannot be executed.
y For quality improvement, specifications are subject to change without prior
notice.
y This equipment is intended to be used for only one patient.
z ECG Monitoring
CAUTION
y Use only the specified relay cables, lead cables, and electrodes.
y The conductive parts of electrodes and associated connectors for applied parts,
including the neutral electrode, should not contact other conductive parts
including earth.
y The indication for continuous use of the electrode is about one day.
y Replace the electrode if the skin contact gets loosen due to perspiration.
y When an electrode is attached to the same location for a long period, some
patients may develop skin irritation. Check the patient’s skin condition
periodically and change the electrode site as required.
y Even the ECG waveform has a minimum threshold level, QRS Automatic
Detection may not be automatically conducted.
y The following EGC may not be automatically detected.
・ The QRS amplitude is low and the QRS width is extremely wide.
・ The interference of artifacts such as EMG or body motion is large.
・ Loud noise is generated by electrosurgical instruments.
y There are some cases when the pacemaker pulse can not be detected
depending on the pacemaker type, pulse voltage, pulse width, electrode lead
type (unipolar, bipolar), or electrode placement which causes the pacemaker
pulse amplitude to decrease and disables the pacemaker pulse detection.
y If signals similar to a pacemaker pulse are present, such as electric blanket
noise or excessive AC frequency noise, these may be erroneously detected and
displayed as a pacemaker pulse.
y When the spontaneous QRS and pacemaker pulse overlaps (as in a fusion
beat), QRS detection will be suspended and the heart rate will be reduced.
y If a pacemaker pulse is continuously detected due to AC frequency interference,
QRS detection will be suspended and the heart rate will be reduced.
z Arrhythmia Analysis
y For proper arrhythmia detection and ECG monitoring, verify proper electrode
placement, lead selection, and ECG waveform size. If necessary, turn ON the
AC filter. Improper electrode placement, lead selection, and ECG waveform size
can cause errors in detection.
z Respiration Monitoring
y When a defibrillator is used during respiration monitoring, a large offset voltage
will be placed on the ECG electrodes, which may cause interruption of
monitoring for a few seconds.
z SpO2 Monitoring
y If the nail is rough, dirty, or manicured, accurate measurement will not be
possible. Change the finger or clean the nail before attaching the probe and
sensor.
y If irritation such as skin reddening appears with the sensor use, change the
attachment site or stop using the sensor.
y When attaching the sensor with tape, do not wrap the tape too tight. At the
same time, check the blood flow constantly so that congestion is not generated
at the peripheral.
y Even a short duration of attachment may inhibit the blood flow and generate
compression necrosis and burn injury. SpO2 may not be measured correctly
because of inhibition of blood flow.
y Change the sensor attachment site constantly (every 4 hours). As the
temperature of sensor attachment site normally rises 2 to 3°C, compression
necrosis and burn injury may generate.
y As the skin of neonate/low birth weight infant is immature, change the sensor
attachment site more frequently depending on the condition.
y Direct sunlight to the sensor area can cause measurements error. Place a black
or dark cloth over the sensor.
y When not measuring, unplug the relay cable and sensor from the SpO2
connector. Otherwise, the outside light may affect to falsely display
measurements.
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y Precautions for Reusable Sensor
・ The light-emitting part of the sensor should be over the root of the fingernail.
Do not insert the finger too far into the sensor as it may hurt the patient.
®
・ Nellcor sensor, DS-100A is intended for use on finger of adults weighing
over 40 kg (approximate). Do not use them on children or neonates. Also do
not apply them on the thumb or foot.
・ The DS-100A is not designed for long-term use. Remove the sensor every 4
hours. If any inhibition is detected in tissue blood flow, replace it or move the
sensor to another finger.
y Precautions for Single-Patient-Use Type Sensor
・ Do not secure the adhesive tape too tight as it may obstruct the blood flow.
・ Do not use the sensor on patients who exhibit allergic reactions to the
adhesive tape.
®
・ Nellcor sensor OXISENSORⅢ, MAX Fast is a sterilized product which can
be reused on the same patient as long as it is still adhesive to the skin.
®
・ Masimo LNOP sensor can be reused on a same patient if the light emitting
and receiving part is clean, and if it is still adhesive to the skin. Do not reuse it
on other patient.
®
・ Nellcor sensor OXISENSORⅢ, MAX Fast can be continuously used on the
same site for maximum 8 hours only if the applied part is periodically checked
and observed that the applied part is correctly attached and no abnormality
on the skin and adherence of the sensor should be found.
・ Do not resterilize.
・ After using this unit, dispose it. Even if this unit is unused, dispose it once it is
opened.
®
y For Masimo sensor, check the sensor attachment site constantly (in every 4
hours when the reusable sensor is used, and at least every 8 hours when the
disposable sensor is used). Be especially careful of a patient with bad perfusion.
If the sensor attachment site is not changed constantly, skin irritation or skin
necrosis due to compression may be developed. For the patient with bad
perfusion, check the sensor attachment position at least every 2 hours.
CAUTION
x
z NIBP Monitoring
y Select the appropriate cuff size which best fits the arm circumference. If the cuff
size is inappropriate, it may cause measurement error.
y Do not use a cuff which is worn out. The cuff may burst during inflation.
y Make surethat the cuff hose connection is secure. If there is any air leakage,
correct NIBP measurement cannot be performed.
y Correct NIBP measurement cannot be performed if artificial heart lung machine is
used or if the pulse is difficult to detect.
y Correct NIBP measurement cannot be performed if artificial heart lung machine is
used or if the pulse is difficult to detect.
y Pay attention when measuring the NIBP of patient with bleeding disorders or
hyper coagulation. The cuff inflation may cause petechia or circulatory failure by
the blood clot.
y Always display the NIBP numeric data box on the display in the main unit when
NIBP is measured. If the NIBP start/stop key of HS-8000 is pressed when the
NIBP Numeric Data Box is not displayed, although measurement is performed,
the measurement result will not be displayed.
y Do not apply the cuff to the arm or thigh where vein is secured. The blood may
backflow causing the chemical injection to cease.
y During measurement, check that the cuff and air hose are not either squashed or
bent. If the exhaust is not properly conducted and the air remains in the cuff over
a long period, the blood circulation will be blocked and congestion may occur.
y Check the patient’s condition constantly while measuring over a long period of
time with interval of 2.5 minutes or less. Also, periodically check the blood
circulation while performing periodic measurement over a long period of time.
Congestion or rash may occur at the measuring site.
y The following factors may affect the NIBP value.
・Body motion, arrhythmia, convulsion
・Continuous noise such as cardiac massage
・Periodic electromagnetic noise
y For the following situation, measurements will be terminated.
When the measurement time has exceeded 160 seconds for adult and child, 80
seconds for neonate.
When the inflation value has exceeded 300mmHg for adult, 210mmHg for child,
and 150mmHg for neonate.
Page 15
z BP Monitoring
y The zero balance procedure is required for the following case.
・ When starting the measurement.
・ When the position of the heart has changed due to body movement.
・ When the transducer position has changed.
・ When measuring for a long period of time and there is a possibility of
measurement error due to change in ambient temperature, etc.
・ When a connector is connected / disconnected, or a transducer is replaced.
z CO2 Monitoring
y On the DS-8500 system, when the Multigas Unit MGU-800 series is used, CO2
measurement by the GAS Unit which is connected to the HS-8000 series (for
example the Capnostat 5 using HPD-800) cannot be performed.
y The disposable airway adapter should be opened just before use. Do not sterilize
it or it will become unusable.
y Do not reuse the disposable airway adapter.
y Do not sterilize the reusable airway adapter using autoclave methods.
z CO2 Monitoring by Gas Unit I/F HPD-800
y The airway adapter should be attached with the thicker side facing to the patient.
If attached oppositely, it may damage the CO2 sensor or airway adapter.
z Temperature Monitoring
CAUTION
y Do not reuse the probe cover. Use it for a patient only and dispose it after using
it.
z Maintenance
y Clean the equipment and relay cables frequently so stains can be removed
easily.
y To prevent injury, it is recommended to wear gloves when cleaning the
equipment.
y Do not allow liquids or cleaning solution to enter the equipment or connectors.
y Do not use organic solvents, thinner, toluene or benzene to avoid damaging the
resin case.
y Do not polish the housing with abrasive or chemical cleaner.
y When sterilizing the entire room using a spray solution, pay close attention not to
have liquids get into the monitor or connectors.
y Use only neutral detergent to clean the housing. Do not use chemical cloth, scrub
brush, abrasive, polishing powder, hot water, volatile solvent and chemicals
(cleanser, thinner, toluene, benzine, benzol, and synthetic detergent for house
and furniture), or sharp-edged tools. The surface resin coating may be damaged,
resulting in discoloration, scratches, and other problems.
y Do not open the housing.
y Avoid alcohol or other liquids from getting into the device.
y If you accidentally wet the device, dry it completely and verify it operates safely
before usage.
y Replace the periodic replacement parts periodically as specified.
Precautions for Use of SpO2 Sensor
Burn Risk in Using SpO2 Sensor
CAUTION
In SpO2 monitoring, always use the sensor/relay cable (patient cable) specified by
Fukuda Denshi. If any other sensor/relay cable (patient cable) is used, a high
temperature rise of the sensor may place the patient in danger of burns.
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Precautions about Masimo® SpO2 measurement unit (HS-8312M)
®
Do not connect the products which are not authorized by Masimo . If you
C A U T I O N connect such products, Fukuda Denshi shall not be liable for any trouble.
Precautions for Use of NIBP Cuff
The NIBP cuff used in this product contains natural rubber latex (excluding
latex-free cuff).
Natural rubber latex may cause allergic reactions, such as itch, redness, hives,
C A U T I O N swelling, fever, respiratory difficulty, asthma symptom, blood pressure
reductions, or shock symptom. If such a symptom occurs, immediately cease
the operation and take appropriate measures.
Disposing of Equipment, Accessories, or Components
When disposing of this product, accessories, or components, use an industrial
C A U T I O N waste distributor. Do not dispose of as ordinary waste.
Precautions about Transportation
For transporting the HS-8000 system, pack with specified packing materials.
Reference
Refer to “2. Specification” for Environmental Conditions during transportation.
Precautions about RTC or Data Backup
z This unit is equipped with a built-in clock, and its time links with the time of
the main unit. Even if the power of this equipment is turned OFF, a lithium
battery updates backup of the time. Every time the main unit is turned ON,
the time of the main unit is set up.
z Even if the power is turned OFF, a lithium battery backs up the list or trend
data. If these data are not backed up after the power is turned ON, a low
CAUTION
battery may be the cause. In such a case, contact Fukuda Denshi service
representative for replacing the battery.
z To protect the BP zero balance data during voltage dip, short interruptions
and voltage variations on power supply input lines or during short duration
of power turned OFF, this monitor performs 5-minute (approx.) backup
using the lithium battery.
To Prepare for Emergency Use
1. Accessories / Optional Accessories
(1) The ECG electrodes are consumable products. Always prepare extra supplies of
electrodes.
(2) Verify that there is no broken wire on the patient cable. Check the operation once a
week.
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Contents
Preface
Chapter 1 General Description
This chapter describes the outline of this equipment.
Chapter 2 Specification
This chapter describes electrical and mechanical
specification.
Chapter 3
Names of Parts and Their
Functions
This chapter describes connectors of this unit.
Chapter 4 Operational Description
This chapter describes block diagram and function of
this unit.
Chapter 5 Spare Parts List
This chapter describes electrical parts and cables inside
equipment.
Chapter 6 Assembly Diagram
This chapter describes assembly diagram.
Chapter 7 Software Upgrade
Procedure
This chapter describes software upgrade of this unit.
Chapter 8 Troubleshooting
This chapter describes points to be checked and
procedure toward trouble symptoms.
Chapter 9 Maintenance
This chapter explains Test Menu for maintenance and
how to store and clean.
Chapter 10 Periodic Check
This chapter explains daily check and periodic check.
xiii
Page 18
Preface
Safety Precautions ·························································· ii
Graphic Symbols ······················································· ii
Precautions for Safe Operation of Medical Electrical
Equipment ································································ iii
Precautions about the Maintenance ························· iv
Precautions about the Pacemaker···························· iv
Non-Explosion Proof··················································v
Defibrillation Safety····················································v
Precautions about the Mason-Likar System ··············v
●ECG Recording by the Mason-Likar System ····v
●Electrode Placement ········································v
Electrosurgery Safety ··············································· vi
Precautions about Magnetic Resonance Imaging ···· vi
Precautions about Connections to Peripheral
Devices···································································· vii
Accessories and Optional Accessories···················· vii
Precautions about the HS-8000 System················· viii
Precautions for Use of SpO2 Sensor ······················· xii
Precautions about Masimo® SpO2 measurement
unit (HS-8312M) ····················································· xiii
Precautions for Use of NIBP Cuff ··························· xiii
Disposing of Equipment, Accessories, or
Components ··························································· xiii
Precautions about Transportation··························· xiii
Precautions about RTC or Data Backup················· xiii
To Prepare for Emergency Use ······························ xiii
Chapter 1 General Description
General Description ···················································· 1-2
Features ································································ 1-3
Chapter 2 Specification
Specification / Performance ········································ 2-2
Specification ·························································· 2-2
Performance ·························································· 2-4
Chapter 3 Names of Parts and Their
Functions
Name of Parts and Their Functions····························· 3-2
HS-8312N, 8312M················································· 3-2
【Front Side】 ················································· 3-2
【Rear Side】·················································· 3-2
【Left Side】···················································· 3-3
Chapter 4 Operational Description
Super Unit HS-8000 ·····················································4-2
HS-8000 Main Unit Configuration Diagram ············4-2
Main CPU block diagram········································4-5
CPU Board Circuit Explanation ······························4-6
ECG Board Block Diagram···································4-11
Analog Board Circuit Explanation ·························4-12
Multi AMP Board Block Diagram ··························4-16
Multi AMP Board Circuit Explanation····················4-17
Mother Board Block Diagram ·······························4-20
Mother Board Circuit Explanation ·························4-21
NIBP Module NIBP-801 ·············································4-25
NIBP-801 Module Configuration Diagram ············4-25
NIBP Module Board Block Diagram······················4-26
NIBP Module Board and Display Panel Board
Circuit Explanation················································4-27
Chapter 5 Spare Parts List
HS-8000 Main Unit Block Spare Parts ·························5-2
NIBP Module (NIBP-801) Spare Parts ·························5-2
Chapter 6 Assembly Diagram
HS-8312M Accembly1 HS-8312M-01A·············6-2
HS-8312M Assembly2 HS-8312M-02A·············6-3
HS-8312M Assembly3 HS-8312M-03A·············6-4
HS-8312M Assembly4 HS-8312M-04A·············6-5
HS-8312N Assembly1 HS-8312N-01A ·············6-6
HS-8312N Assembly2 HS-8312N-02A ·············6-7
NIBPS-801 Assembly NIBP-801-01A ···············6-8
Chapter 7 Software Upgrade Procedure
Software Upgrade ························································7-2
Upgrading method only in HS-8000 ·······················7-2
Upgrading method using Main Unit ························7-5
Software Version··························································7-6
Chapter 8 Troubleshooting
HS-8000 series Super Unit·····································8-2
ECG········································································8-3
Respiration ·····························································8-6
Non-Invasive Blood Pressure ·································8-7
SpO2 (HS-8312N)·················································8-10
SpO2 (HS-8312M) ················································8-11
Invasive Blood Pressure·······································8-13
Temperature·························································8-13
CO Measurement ·················································8-14
Analog Output ······················································8-17
Chapter 9 Maintenance
DIP Switch Setup ·························································9-2
HS-8000 DIP Switch Setup ····································9-2
Test Menu ····································································9-3
To Display the Test Menu·······································9-3
xiv
Page 19
Test Menu Description··········································· 9-3
Test Menu Details·················································· 9-5
Storage······································································ 9-17
Storing the Device ··············································· 9-17
Cleaning ···································································· 9-18
Cleaning the Housing ·········································· 9-18
Periodic Replacement ··············································· 9-19
Replacement of NIBP Unit··································· 9-20
Chapter 10 Periodic Check
Maintenance Check
Daily and Periodic Check ···································· 10-2
About Maintenance Check ·································· 10-2
●Daily Check ················································ 10-2
●Periodic Check ··········································· 10-2
Periodic Replacement Period for Each Part ········ 10-2
Daily Check ························································· 10-3
●Daily Check Procedure······························· 10-3
●Daily Check List·········································· 10-4
Periodic Check ···················································· 10-5
●Introduction················································· 10-5
●Service tools/Measurement Device ············ 10-5
●Periodic Check Item ··································· 10-6
●Periodic Check Procedure·························· 10-6
●Periodic Check List··································· 10-12
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Page 20
Blank Page
xvi
Page 21
Chapter 1
General Description
General Description ····················································· 1-2
Features ··································································· 1-3
1－1
Page 22
General Description
The HS-8000 series Super Unit is a multiparameter measurement unit. It is connected to the
DS-8500 System Patient Monitor.
This unit allows measuring multiple parameters such as ECG, Resp., NIBP, SpO2, BP,
Temperature, and CO. It acquires patient’s vital signs and performs signal filtering and
measurement processing. The processing results, such as waveforms and measurement data, are
displayed on the Patient Monitor screen and each operation is performed on the Patient Monitor.
For measuring the arterial oxygen saturation (SpO2), there are 2 types of Super Units depending
®
TM
®
on the built-in SpO2 module, COVIDIEN /Nellcor or MASIMO .
In addition, the multiparameter connectors allow measuring the parameters of TEMP, BP, and CO.
<HS-8000 series>
There are different types of model available depending on the number of ECG electrodes; 5 or 10.
And also the arterial oxygen saturation (SpO2), models with built-in SpO2 modules manufactured
TM
®
by Nellcor or MASIMO are available.
Also, the HS-8000 series has Multiconnector and can selects and measures the parameters such
as TEMP, BP and CO.
【Lineup of Super Unit】
Model Type
Fixed
SpO2 module
Multiparameter
Measuring Items
CO2
Measurement*1
ECG
(10 electrodes) x
max. 12-leads
HS-8312N
Yes
NellcorTM
RESP x 1
NIBP x 1
3 ports
SpO2 x 1
ECG
TEMP x 6 (max.)
(10 electrodes) x
IBP x 6 (max.)
max. 12-leads
CO x 1 (max.)
RESP x 1
MASIMO®
HS-8312M*3
Yes
NIBP x 1
SpO2 x 1
SpCO*2 x 1
SpMet*2 x 1
*1: For CO2 measurement, the external option unit, CO2 Gas Unit HCP-800 or Gas Unit I/F
HPD-800, is necessary.
*2: Available only with HS-8312M. SpCO and SpMet are available as option.
*3 The HS-8312M allows the display of measurement condition such as PI (Perfusion Index), PVI
(Pleth Variability Index), Signal IQ. Note that PVI is available as an option..
1－2
Page 23
Features
y With the multiparameter connectors, any combination measurement of parameters (BP, TEMP,
and CO) is available depending on the patient condition.
y The equipment has keys for alarm silence, BP zero balance, and NIBP start/stop.
y The equipment also has an analog output connector to output analog signal (1ch ECG waveform,
2ch BP waveform) and QRS SYNC signal.
y By connecting the HPD-800 Gas Unit I/F or the HCP-800 CO2 Gas Unit (both external option) to
an AUX connector, CO2 measurement is possible.
1－3
Page 24
Blank Page
1－4
Page 25
Chapter 2
Specification
Specification / Performance ········································ 2-2
Specification ····························································· 2-2
Performance····························································· 2-4
2－1