Fukuda LX-7230N Manual de usuario
i
Thank you for purchasing this product.
Before using this product, read this operation manual thoroughly for
correct handling and operation.
In this manual, the operation procedure of LX-7230N/LX-7230N(G) is
explained using the illustration and screen of the LX-7230N as examples.
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.
DANGER Failure to follow this message may cause immediate
threat of death or serious injury.
WARNING Failure to follow this message may result in death or
serious injury.
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.
Precaution from Fukuda Denshi
Fukuda Denshi is liable 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.
ii
Intended Use of this Equipment
This equipment is designed for the following <Intended Use>.
<Intended Use>
This equipment is intended for patient monitoring in surgery room, ICU, ward,
emergency room in the medical facility by measuring ECG, Respiration and SpO2
and transmitting the measured data by wireless network to the central monitor
continuously.
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.
・ Hazard to the Life and Health of the Patient or the User
・ A Problem Related to Medical Practice
・ Damage to the Equipment
iii
Graphic Symbols
The following symbols are used for this equipment.
Symbols indicated on the main unit
Symbol Description
Warning (indicated in yellow)
Follow operating instructions (Warning); (indicated in blue)
Indicates that the failure to follow operating instructions
could place the patient or operator at risk.
Type CF Applied Part with Defibrillation-Proof
Indicates that the degree of protection against electric
shock is Type CF Applied Part with defibrillation-proof.
No Alarm Function
Indicates no alarm function.
Battery compartment lid lock
Indicates locking and unlocking of the battery
compartment lid.
Battery Type and Direction
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.
iv
Symbols indicated on the LCD screen
Symbol Description
Heart Rate Synchronization Mark
This mark flashes synchronizing to the heartbeat.
Battery Mark
Indicates the remaining battery level.
v
Precautions for Safe Operation of Medical Electrical Equipment
Cautions described here are regarding the general instructions for safety use
to the patient and users. As for cautions about the LX-7230N/LX-7230N(G),
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.
Do not install or store in an area where the equipment will be subject to
splashing water.
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.
Place the equipment on a stable surface where there is no inclination,
vibration, or shock (including during transportation).
Do not install or store in an area where chemicals are stored or gases are
evolved.
3. Before operating the equipment, verify the following items.
Check the cable connection and polarity to ensure proper operation of the
equipment.
Ensure that all cables are firmly and safely connected. Especially, recheck
the attachment and connection condition of electrode and the probe
(sensor).
Pay special attention when the equipment is used in conjunction with other
equipment as it may cause erroneous judgment and danger.
Check the remaining battery level.
When 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.
Do not operate the equipment beyond the time period required for
diagnosis and medical care.
Do 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.
Always observe the equipment and patient to ensure safe operation of the
equipment.
If 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.
Do not allow the patient to come in contact with other equipments.
vi
CAUTION
5. After using the equipment, verify the following items.
Make sure to turn off the power of the equipment.
When unplugging the cables, do not apply excessive force on the cable
and pull from its connector.
Clean the accessories and cables, and keep them together in one place.
Keep the equipment clean to ensure proper operation for the next use.
Make sure to remove the batteries if the equipment is not used for a long
time. The leakage from the batteries may damage the equipment or an
explosion from the batteries 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. User should not
attempt service. Label the unit “OUT OF ORDER” and contact
Fukuda Denshi representative.
7. Do not remodel the equipment.
8. Maintenance Check
Make sure to periodically check the equipment, and accessories.
Before 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.
To prevent burn injury to the patient, verify proper attachment of patient
ground plate, 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.
Some types of equipment other than the 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.
Non-Explosion Proof
DANGER
Never operate the equipment in the presence of flammable anesthetics,
high concentration of oxygen. It may cause an explosion or fire.
Never operate the equipment inside a hyperbaric chamber. It may cause
an explosion or fire.
Never operate the equipment where flammable gas or fluid such as
anesthetic, oxygen, and hydrogen are used. It may cause an explosion
or fire.
vii
Defibrillation Safety
WARNING
Use 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.
When 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.
When 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.
This equipment will return to standard operating mode within 10
seconds after defibrillating. The stored data will not be affected. The
measurement accuracy will temporarily decrease during defibirillation,
but it will not compromise the safety of patient and the equipment.
Precautions about Magnetic Resonance Imaging (MRI)
WARNING
Do not operate this equipment in magnetic resonance imaging (MRI)
environments.
When 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.
viii
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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