Fukuda Denshi LX-8000 Series User manual

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Thank you for purchasing our product.
Before using this product, read this operation manual thoroughly for correct
handing and operation.
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Safety Precautions
Read the “Safety Precautions” thoroughly before use to ensure correct and
safe use of the product. Make sure to follow the precautions indicated below,
as these are important messages related to safety.
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DANGER Failure to follow this message may cause
immediate threat of death or serious injury, or
complete failure of the equipment.
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WARNING Failure to follow this message may result in death
or serious injury, or complete failure of the
equipment.
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CAUTION Failure to follow this message may cause injury or
failure of the equipment.
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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.
Precaution from Fukuda Denshi
Fukuda Denshi is responsible for the safety, reliability, and performance of its
equipment only if;
Maintenance, modifications, and repairs are carried out by authorized
personnel. Components are used in accordance with Fukuda Denshi operating
instructions.
If the equipment is used incorrectly and become unusable, Fukuda Denshi is
not liable for the malfunction. Use the equipment only for the purpose specified
in this manual.

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Intended Use of this Equipment
This equipment is designed for the following <Intended Use>.
<Intended Use>
This equipment is intended for measuring parameters of ECG, respiration in surgery
room, ICU, ward, emergency room in the medical facility and transmitting the
measured data by wireless network to the central monitor continuously.
This equipment is intended for monitoring one patient. It is not intended for
monitoring multiple patients.
For specification of this equipment, refer to "Chapter 14 Specification" of this
manual.
This equipment is intended to be used by healthcare professionals. Users should
have a thorough knowledge of the function and operation before using this
equipment. The maintenance of this equipment should be performed by skilled
personnel who received a training of possible hazards and measures to avoid those
hazards. Also, your local regulation must be followed. If this equipment is used for
the purpose other than intended, or if the user does not follow the safety
instructions, the following hazard may result.
ȷHazard to the Life and Health of the Patient or the User
ȷA Problem Related to Medical Practice
ȷDamage to the Equipment

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Graphic Symbol
The following symbols are used for this equipment.
LX-8100 Symbols indicated on the main unit
Symbol Description
Warning (indicated in yellow)
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Follow operating instructions (Warning); (indicated in blue)
Indicates that the failure to follow operating instructions
could place the patient or operator at risk.
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Type CF Applied Part with Defibrillation-Proof
Indicates that the degree of protection against electric
shock is Type CF Applied Part with defibrillation-proof.
Indicates the power ON/OFF status.
Indicates the point to close the battery compartment lid.
Indicates the battery type and direction
Name and Address of Manufacturer
Date of Manufacture
Indicates the name and address of manufacturer, and
date of manufacture.
Non-ionizing electromagnetic radiation
Indicates the radio transmitting device.
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LX-8100 Symbols displayed on the display screen
Symbol Description
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Synchronized Mark
This mark flashes synchronizing to the heartbeat.
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Indicates the remaining battery level.

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Precautions for Safe Operation of Medical Electrical Equipment
Cautions described here are regarding the general instructions for safety use
to the patient and the users. As for cautions about the LX-8100, please refer
to the following pages.
CAUTION
1. Users should have a thorough knowledge of the operation before
using this equipment.
2. Pay attention to the following when installing or storing the equipment.
yDo not install or store in a place where the equipment will be subjected 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 chemicals are stored or gas may
generate.
3. Before operating the equipment, verify the following items.
yCheck the cable connection and polarity to ensure proper operation of the
equipment.
yEnsure that all cables are firmly and safely connected. Especially, recheck
the attachment and connection condition of electrodes and transducers.
yPay special attention when the equipment is used in conjunction with other
equipment as it may cause erroneous diagnosis and danger.
yCheck the remaining battery level.
yWhen replacing the battery, make sure that the battery polarity is correct.
Do not charge the battery.
4. During operation of the equipment, verify the following items.
yDo not operate the equipment beyond the time period required for
diagnosis and medical care.
yDo not pick up and/or swing the equipment pulling/grabbing the probe
(sensor) or cable part. It may damage the equipment and lead to
measurement error.
yAlways observe the equipment 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 and/or detaching the
probe (sensor) and/or electrode, in the safest way for the patient.
yDo not allow the patient to come in contact with other equipment.

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CAUTION
5. After using the equipment, verify the following items.
yReturn all operating switches, knobs etc to the position before using the
equipment, and then switch off the power.
yWhen unplugging the cables, do not apply excessive force on the cable
and pull from its connector.
yClean the accessories and cables, and keep them together in one place.
yKeep the equipment clean to ensure proper operation for the next use.
yMake sure to remove the battery if the equipment is not used for a long
time. The leakage from the battery may damage the equipment or an
explosion from the battery may occur.
6. If the equipment is damaged and in need of repair, ensure patient
safety by immediately turning the equipment off and remove the
electrodes and/or probe from the patient. Users should not attempt
service. Label the unit “OUT OF ORDER” and contact Fukuda Denshi
representative.
7. Do not disassemble or remodel the eqipment.
8. Maintenance
yMake sure to periodically check the equipment and accessories.
yBefore reusing the equipment that has been left unused for a while, make
sure that the equipment works normally and safely.
9. When using electrosurgical knives or defibrillator with this equipment,
take care of the following.
yTo prevent burn injury to the patient, verify proper attachment of the patient
ground plate, the ECG electrode type for the electrosurgical knives, and the
quantity of gel, output energy for the defibrillator. Also, verify that a proper
ground is selected.
ySome types of equipment other than above may cause accidental hazards
to the patient and operator due to the conditions of the equipment. Read
the operation manual attached to each equipment and understand the
precautionary instructions prior to use.
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Non-Explosion Proof
DANGER
zNever operate the equipment in the presence of flammable
anesthetics, high concentration of oxygen. It may cause an explosion or
fire.
zNever operate the equipment inside a hyperbaric chamber. It may
cause an explosion or fire.
zNever operate the equipment where flammable gas or fluid such as
anesthetic, oxygen, and hydrogen are used. It may cause an explosion
or fire.

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Precautions about Magnetic Resonance Imaging (MRI)
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.
Electrosurgery Safety
WARNING
The monitoring system contains protection against interference generated
by electrosurgical instruments. However, depending on the operating
conditions, surgery site with respect to the location of ECG electrodes,
ground plate attachment condition, or the type of instrument used, it may
cause burn injury at the electrode site or noise on the ECG. The noise is
generated at the tip of the electrosurgical 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 equipment and
the patient cable. This will help reduce interference on the ECG through
the monitor or cables.
Electrode Placement:
The amount of noise 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 and the ground plate. 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 from burn at the electrode site.
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Defibrillation Safety
WARNING
zUse only the lead cable specified by Fukuda Denshi when defibrillating.
If used by unspecified lead cable, the equipment may be damaged,
resulting in a safety hazard.
zWhen using the defibrillator, keep away from the electrodes or
medicament applied to the patient chest. If this is not possible, remove
the electrodes or medicament before using it.
If the defibrillator paddles are directly in contact with the electrodes or
medicament, an electrical shock may result from the discharged
energy.
zWhen using the defibrillator, do not touch the patient and the metal part
of the equipment or cables. Electric shock may result from the
discharged energy.
Precautions about the Pacemaker
WARNING
zMinute ventilation rate-adaptive implantable pacemakers can
occasionally interact with certain cardiac monitoring 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, disconnect the cardiac monitoring and diagnostic
equipment, or follow the procedures described in the operation manual
of the pacemaker.
(For more details, contact FUKUDA DENSHI personnel, your
institution’s professionals, or your pacemaker distributors.)
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.
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 – FDA]