Fukuda Denshi HS-8000 Series User manual

Super Unit
●●●●●●●●●●●●●●●●●●●●●●●●●●●●
HS-8000 Series
Service Manual
zBefore setting up/maintenance, please read this “Service Manual” thoroughly.
zAfter reading, keep this manual for future use.

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Service Manual (No. ): Q’ty 1
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Fukuda Denshi Co., Ltd.
Development & Production Support Dept.
2-35-8 Hongo Bunkyo-ku, Tokyo, 113-8420 Japan
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Revision History
Model Name
HS-8000 Series Service Manual
Edition Revised Items Reason of the Revision Revised Date
1 － New Edition 2011.8

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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 SpO2Sensor ··························· xi
Precautions about Masimo® SpO2measurement 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
i

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

Precautions for Safe Operation of Medical Electrical Equipment
CAUTION
Read the following precautions thoroughly to correctly operate the device.
zUsers should have a thorough knowledge of the operation before using
this system.
zPay attention to the following when installing and storing the equipment.
yDo not install or store in an area where the equipment will be subject to
splashing water.
yDo not install or store in an area where the environmental conditions, such as
atmospheric pressure, temperature, humidity, ventilation, sunlight, dust, sodium,
sulfur, will adversely affect the system.
yPlace the equipment on a stable surface where there is no inclination, vibration,
or shock (including during transportation).
yDo not install or store in an area where there are chemical or gasses stored.
zBefore operating the system, verify the following items.
yVerify the power voltage.
yCheck the cable connection to ensure proper operation of the unit.
yEnsure that all cables are firmly and safely connected.
yPay special attention when the device is used in conjunction with other
equipment as it may cause erroneous judgment and danger.
yEnsure all patient connections are proper and secure.
zDuring operation of the system, verify the following items.
yAlways observe the system and patient to ensure safe operation of the
equipment.
yIf any abnormality is found on the equipment or patient, take appropriate
measures such as ceasing operation of the equipment in the safest way for the
patient.
yDo not allow the patient to come in contact with the device.
zAfter using the system, verify the following items.
yUnplug all the cables from the patient before turning off the power.
yWhen unplugging the cables, do not apply excessive force by pulling on the
cable. Pull by the connector part of the cable.
yClean the accessories and cables, and keep them together in one place.
yKeep the unit clean to ensure proper operation of the next use.
zDo not remodel the equipment.
zMaintenance Check
yMake sure to periodically check the equipment, accessories and cables.
yBefore reusing the device that has been left unused for a while, make sure that
the device works normally and safely.
zTo 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.
iii

Precautions about the Maintenance
Safety Inspection and Maintenance
For safe operation of the equipment, regular inspection and maintenance is required. Once a year,
check all cables, devices, and accessories for damage, earth impedance, earth and leakage
currents, and all alarm functions. Also, ensure that all safety labels are legible. Maintain a record of
these safety inspections.
Immediate maintenance has to be carried out if ;
ythe equipment was subjected to extreme mechanical stress, e.g. after a heavy fall.
ythe equipment was subjected to liquid spill.
ythe monitoring function is interrupted or disturbed.
yparts of the equipment enclosure are cracked, removed, or lost.
yany connector or cable shows signs of deterioration.
Reference Refer to “12. Periodic Check” for details.
WARNING Never open the housing while the equipment is in operation or connected to
hospital grade outlet as it may result in electric shock.
Maintenance, Modifications, and Repairs
Fukuda Denshi is liable for the safety, reliability, and performance of its equipment only if;
yMaintenance, modifications, and repairs are carried out by authorized personnel.
yComponents are used in accordance with Fukuda Denshi operating instructions.
Precautions about the Pacemaker
WARNING
zMinute 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
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]
zRate 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.
iv

Non-Explosion Proof
DANGER
Never operate the equipment in the presence of flammable anesthetics, high
concentration of oxygen, or inside hyperbaric chamber. Also, do not operate
the equipment in an environment in which there is a risk of explosion.
Explosion or fire may result.
Defibrillation Safety
WARNING
zWhen 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.
zWhen 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.
zWhen 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
CAUTION
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
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.
v

Electrosurgery Safety
WARNING
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.
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
WARNING
zDo not operate this equipment in magnetic resonance imaging (MRI)
environments.
zWhen conducting MRI test, remove the electrodes and sensors connected
to the patient (test subject).
The local heating caused by the induced electromotive force may cause burn
injury to the patient (subject). For details, refer to the operation manual for the
MRI testing device.
vi