Fukuda LX-7230N User manual



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.

ix
Precautions about the Pacemaker
WARNING
Minute 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.)
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.
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]
Precautions about the LX-7230N/LX-7230N(G)
WARNING
Do not connect cables not authorized by Fukuda Denshi to any I/O
connector. If done so by mistake, the LX-7230N/LX-7230N(G) cannot
deliver its maximum performance and may be damaged, resulting in a
safety hazard.
Do not use this equipment with multiple patients simultaneously.
This equipment itself has no alarm function. Do not use it if an alarm
function is necessary. The alarm function with the receiving monitor,
refer to the operation manual of the receiving monitor.
CAUTION
Do not pick up and/or swing the LX-7230N/LX-7230N(G) pulling/grabbing
the probe (sensor) or cord part. The cable could break or get disconnected
from the LX-7230N/LX-7230N(G). And it may hit people or damage other
equipment around.

x
Precautions about Waterproof
CAUTION
Replace the “Battery Compartment Lid” of the LX-7230N/LX-7230N(G)
regularly to keep the performance of waterproof. If not regularly
replaced, the quality of the lid will deteriorate and cannot keep the
waterproof performance. For details about the regular replacement,
contact your local Fukuda Denshi service representative.
The lid may be damaged from high impact. If the LX-7230N/LX-
7230N(G) is dropped or is subjected to a high impact, make sure that
the lid is not damaged.
However, the SpO2 probes (sensors) are not waterproof. Do not take a
bath with them, and ensure to be away from liquid.
Do not use the LX-7230N/LX-7230N(G) wet. Always wipe the LX-
7230N/LX-7230N(G) with a soft cloth and dry it thoroughly before use.
Precautions about ECG
CAUTION
When removing electrodes from the patient, remove them carefully and
slowly. Do not apply excessive force to remove them. Otherwise, it may
damage the skin.
If any electrodes get detached from the patient after being connected to
the lead cable and the patient monitor, pay attention that the metal part
of the electrode does not get in touch with any metal parts of the bed or
any conductive parts. Also, the operator should not touch any
conductive parts with bare hands. Otherwise, it may cause electric
shock to the patient and/or operator due to excessive leakage current.
The indication for continuous use of the electrode is about one day.
Replace the electrode if the skin contact gets loosen due to perspiration,
etc.
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.
For stable ECG monitoring, verify proper electrode placement, lead, and
waveform size. If not properly selected, it may cause erroneous
detection.
There are some cases when the pacemaker pulse cannot be detected
depending on the pacemaker type, pulse voltage, pulse width, electrode
lead type (unipolar, bipolar), electrode placement, or lead method which
causes the pacemaker pulse amplitude to decrease and disables
pacemaker pulse detection.
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. In this case,
check the condition of the electrodes and ECG lead cable to resolve the
cause or turn off the pacemaker detection setting on the receiving
monitor.

xi
CAUTION
If a pacemaker pulse is continuously detected due to AC frequency
interference, QRS detection will be suspended and the heart rate will be
reduced.
If an arrhythmia accompanied by an irregular rhythm occurs, there is a
possibility of temporarily displaying an incorrect heart rate. When using
this device in conjunction with an electrocautery scalpel, noise from an
electric scalpel may be misrecognized as heartbeat or arrhythmia.
Precautions about SpO2
WARNING
During SpO2 monitoring, always use the probe (sensor) specified by
Fukuda Denshi. Also, check the probe before usage to make sure that it
is the specified probe. If unspecified probe is used, not only that the
equipment cannot deliver its maximum performance, the equipment may
be damaged and safety cannot be ensured.
If irritation such as skin reddening appears with the sensor use, change
the attachment site or stop using the sensor.
Do not use a tape to attach the sensor.
When the SpO2 probe (sensor) is in a connector-off condition, the SpO2
alarm will not be generated on the receiving monitor. Make sure that the
SpO2 probe (sensor) is securely connected. If the SpO2
waveform/numeric data is not displayed, check the patient’s condition
and pay attention not to miss the connector-off condition.
When not performing measurement, unplug the sensor from the SpO2
connector. Otherwise, the measurement data may be erroneously
displayed by the ambient light.
Check the sensor attachment site constantly every 4 hours when probes
or reusable sensor are used, and at least every 8 hours when single
patient use sensors are used. Be especially careful of a patient with bad
perfusion. If the sensor attachment position 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.
As skin for neonate, premature infant is immature, change the sensor
attachment site more frequently depending on the condition.
When measuring the SpO2 of a patient with high fever or peripheral
circulatory insufficiency, check the probe (sensor) attachment
periodically and change the attachment site. The temperature of the
attachment site will rise 2C to 3C due to the sensor heat which may
result in compression necrosis and burn injury.
Even attachment for a short duration may inhibit the blood flow and
generate compression necrosis or burn injury. Also, blood flow inhibition
may prevent correct measurements.

xii
WARNING
Direct sunlight to the sensor area can cause measurement error. Place
a black or dark cloth over the sensor.
The pulse wave is normalized for SpO2 measurement, and does not
indicate perfused blood volume. Check proper probe attachment by
observing the pulse wave.
Precautions for Reusable Sensors
The light-emitting part of the sensor should be over the root of the
fingernail or as instructed per the related sensor instruction manual.
Do not insert the finger too far into the sensor as it may hurt the patient.
For details, refer to the SpO2 sensor instruction manual.
Precautions for Single-Patient-Use Type Sensors
The sensor can be reused on the same patient as long as the adhesive
tape attaches without slippage. But do not reuse on other patients to
avoid cross contamination. It is intended for single patient use only. For
details, refer to the SpO2 sensor instruction manual.
Measuring on a limb with NIBP cuff, arterial catheter, or intracatheter
may result in incorrect measurement.
Venous congestion may cause under reading of actual oxygen
saturation. Therefore, assure proper venous outflow from monitored site.
Sensor should not be below heart level (e.g. sensor on hand of a patient
in a bed with arm dangling to the floor).
CAUTION
For the following case, accurate measurement may not be possible.
Patient with excessive abnormal hemoglobin (COHb, MetHb)
Patient with the pigment injected to the blood
Patient receiving CPR treatment
Placement of SpO2 probe (sensor) on limb with a blood-pressure cuff,
arterial catheter, or intravascular line
When measuring at placement position with venous pulse
Patient with body motion
Patient with small pulse
Excessive body motion (patient’s motion)
Excessive light (direct sunlight, fluorescent, light therapy equipment,
surgical light, infrared heat ramp, etc.)
External colorant such as nail polish
Abnormally low or high hemoglobin concentration
Electrosurgery
Influence of electromagnetic waves from other electronics devices
High-intensity radio waves from mobile phones

xiii
Precautions about Output Signal
WARNING
Do not use the output signal of the monitor that receives radio wave signal
from the LX-7230N/LX-7230N(G) as the trigger signal for IABP, MRI
echocardiographic, or defibrillator for the following reasons.
It may lead to a delay of operating timing due to the delay time of
waveform transmission.
A trigger signal unrelated to the heart rate may be generated due to the
interfusion of spike noise at weak electric field.
Precautions about Accessories and Optional Accessories
WARNING
Use only the accessories such as disposable electrodes, electrode codes
and SpO2 probe (sensor) specified by Fukuda Denshi. Otherwise, this
equipment cannot deliver its maximum performance and may be damaged,
resulting in a safety hazard.
CAUTION
Do not reuse disposable products.
Store the disposable products properly as mentioned in their user
manuals.
Precautions about Battery
WARNING
Use new "AA" size (“LR06” size) alkaline cell.
Install the battery with the correct polarity.
Do not charge the battery. Any attempt to charge the battery may cause
it to leak or break.
Do not short the (+) and (-) terminals. It may result in exothermic heat
and fire.
Do not throw the battery into fire. It may explode.

xiv
Precautions about Disposing of Equipment, Accessories, or
Components
CAUTION
When disposing of the equipment, accessories, or components, use an
industrial waste distributor. Do not dispose of as ordinary waste.
Used disposal items (ECG electrodes, etc.) shall be discarded as
medical waste.
Precautions about Disposing of Battery
CAUTION
Obey the local municipal rule to dispose the used dry cell battery.
Precautions for Use of Medical Telemeter
WARNING
The LX-7230N/LX-7230N(G) transmitter must not be co-located or
operated in conjunction with any other antenna or transmitter.
For the receiving monitor of the LX-7230N transmitter, make sure to use
the Fukuda Denshi products with the receiving range of 608 MHz-614
MHz.
For the receiving monitor of the LX-7230N(G) transmitter, make sure to
use the Fukuda Denshi products with the receiving range of 1395 MHz-
1400 MHz and 1427 MHz-1432 MHz.
This equipment complies with FCC/IC radiation exposure limits set forth
for an uncontrolled environment and meets the FCC radio frequency
(RF) Exposure Guidelines and RSS-102 of the IC radio frequency (RF)
Exposure rules. This equipment has very low levels of RF energy that
are deemed to comply without testing of specific absorption rate (SAR).
Operation of LX-7230N/LX-7230N(G) requires the prior coordination with
a frequency coordinator designated by the FCC for the Wireless Medical
Telemetry Service.
This radio frequency device is susceptible to interference from outside
sources. Interference may prevent the monitoring of patients connected
to this equipment. If a problem exists, contact your local service
representative.
The LX-7230N/LX-7230N(G) transmits vital signs to the receiving
monitor using radio wave signal. Under unstable radio wave signals, the
receiving monitor will not generate any alarms. This situation may miss
sudden change in the patient's condition and may cause a serious
accident. Under unstable radio wave signals, check the patient status
consistently under this situation. To get stable radio wave signals, make
sure to have a proper telemetry installation.

xv
CAUTION
For installation, make sure of the following.
The medical institution (hereinafter referred to as the “Institution”) must
decide the telemetry installation plan for the medical department in order
to prevent interference and interference between transmitters (telemetry
based on destination country’s radio law). When telemetry has already
been installed and been used, radio format, frequency, and antenna power
are required to be examined to prevent interference.
When laying receiver antenna for each transmitter, the Institution has to
examine the installation so that electronic interference does not occur.
Based on the above examination result, the Institution should install each
receiver antenna as required.
For management, make sure to follow the precautions below.
The Institution should appoint a person (hereinafter referred to as the
“Coordinator”) to manage the wireless channels for the whole Institution.
The Coordinator must be selected from people who understand the
characteristics and functionality of telemetry systems, and are skilled in
operating telemetry.
When installing telemetry, the Coordinator has to understand the
precautions for use of telemetry in advance.
The Coordinator is responsible for maintenance of wireless channels and
storage and maintenance of telemeter in the overall medical facilities to
give proper instructions to the telemetry users.
The Coordinator should create a management log (hereinafter referred to
as the “log”), which contains a list of the management status of the
wireless channels for the whole Institution. When changing a wireless
channel, register it in the log and give proper instructions to the
Coordinator or to the user.
The Coordinator assumes responsibility for managing the wireless
channels, storing, and managing telemetry.
The Coordinator assigns the transmitter to the user, and provides enough
education for use.
The telemetry user verifies operation of the transmitter/receiver before
use.
When interference or breakdown occurs in telemetry communication, the
user is required to inform the Coordinators of the problems. The
Coordinators are to deal with the problem properly and/or contact their
nearest Fukuda Denshi representative for service.

xvi
Electromagnetic Compatibility
The performance of this equipment under electromagnetic environment
complies with IEC 60601-1-2 (2007).
Precautions for Safe Operation under Electromagnetic Influence
CAUTION
If any sorts of electromagnetic wave, magnetic field, or static electricity
exist around the equipment, noise interference or malfunction of the
equipment may occur. If any unintended malfunction or noise occurs
during monitoring, check the magnetic influence and take appropriate
countermeasures.
The following are examples of the common cause and countermeasures.
●Mobile Phone
The radio wave may cause malfunction to the equipment.
Mobile phones and radio sets should be turned off in the room
(building) where medical device is located.
●Static Electricity
In a dry environment (room), static electricity is likely to occur. Take
the following countermeasures.
Both operator and patient should remove any static electricity before
entering the room
Humidify the room

xvii
EMC Guidance
This equipment complies with IEC 60601-1-2 (2007). However, if portable
transmitter or wireless LAN equipment is used extremely nearby, the
electromagnetic influence may largely exceed the compliance level and may
cause unexpected phenomenon such as noise interference on the waveform,
etc.
Therefore, this equipment should be used in a location specified by each
medical institution. If any unexpected noise interference on the waveform or
failure to the peripheral device occurs, stop using the equipment and follow the
instruction of the technician.
The following is the information relating to EMC (Electromagnetic
Compatibility).
(When using this equipment, verify that it is used within the environment
specified below.)
●Compliance to the Electromagnetic Emissions
The LX-7230N/LX-7230N(G) is intended for use in the electromagnetic
environment specified below. The customer or the user of the LX-7230N/LX-
7230N(G) should assure that it is used in such an environment.
Emission Test Compliance Electromagnetic Environment –
Guidance
RF Emission
CISPR 11 Group 1
The LX-7230N/LX-7230N(G) uses RF
energy only for its internal function.
Therefore, its RF emissions are very low
and are not likely to cause any
interference in nearby electronic
equipment.
RF Emission
CISPR 11 Class A
The LX-7230N/LX-7230N(G) is suitable
for use in all establishments other than
domestic establishments.
Harmonic Emission
IEC 61000-3-2 N/A
Voltage Limit /
Flicker Emission
IEC 61000-3-3
N/A

xviii
●Compliance to the Electromagnetic Immunity (1)
The LX-7230N/LX-7230N(G) is intended for use in the electromagnetic
environment specified below. The customer or the user of the LX-7230N/LX-
7230N(G) should assure that it is used in such an environment.
Immunity Test IEC 60601-1-2
Test Level
Compliance
Level
Electromagnetic
Environment Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
2,4,6kV: Contact
2,4,8kV: Air
2,4,6kV:
Contact
2,4,8kV: Air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2kV:
Power supply lines
±1kV:
Input/output lines
N/A
Surge
IEC 61000-4-5
±1kV:
differential mode
±2kV:
common mode
N/A
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines.
IEC61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5sec.
N/A
Power
Frequency
(50/60Hz)
Magnetic Field
IEC 61000-4-8
3A/m 3A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Note: UT is the AC mains voltage prior to application of the test level.
This manual suits for next models
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