Bioland Technology LTD.
No. A6B7 (Block G) ShangRong Industrial Zone No. 5 Baolong Road,
Baolong Community Longgang District 518116, Shenzhen, Guangdong
PEOPLE’S REPUBLIC OF CHINA
Toll-free service line: 800-218-2838
Mon-Fri 9AM-5PM EST
Date of issue: 2019.04.10
Version: V1
Blood Pressure Monitor
Model: 2006-2B
User manual
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14
Table of Content
Table of Content
.............................................................................................................
2
Introduction
....................................................................................................................
2
Precaution before use
.....................................................................................................
3
Few words about blood pressure
...................................................................................
4
PRODUCT DESCRIPTION
..........................................................................................
5
Install or replace batteries
..............................................................................................
6
How to use the upper arm cuff
.......................................................................................
6
A few suggestion before measurement
..........................................................................
7
How to measure blood pressure
.....................................................................................
8
Recalling memory
..........................................................................................................
9
How to prevent a malfunction
.......................................................................................
9
Maintenance and repair
..................................................................................................
9
Specifications
...............................................................................................................
10
Troubleshooting
...........................................................................................................
11
FCC Requirement
........................................................................................................
14
Introduction
Thank you for purchasing this blood pressure monitor. This remarkable instrument
is ideal for people who frequently monitor their own blood pressure because it's
easy to use. Simply push of a button the monitor measures your blood pressure and
pulse and displays the reading on a clear digital panel. Perfect for quick, easy
readings at home, at work, almost anywhere!
The Monitor uses the oscillometric method of blood pressure measurement. This
means the monitor detects your blood's movement through the artery in your arm
and converts the movements into a digital reading. An oscillometric monitor does
not need a stethoscope so the monitor is simple to use and measurements are easy to
obtain.
Clinical research has proven a direct relationship between blood pressure in the
wrist and blood pressure in the arm. Changes in wrist blood pressure reflect
changes in arm blood pressure because the arteries in the wrist and the arm are
connected each other. Frequently measuring the blood pressure will provide you
and your doctor with an accurate indication of changes in your actual blood
pressure.
Please read this user manual thoroughly before using the blood pressure monitor.
For specific information on your own blood pressure, contact your physician.
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Precaution before use
1. Do not confuse
self-monitoring
with
self-diagnoses.
Blood pressure
measurements
should only be interpreted by a health
professional
who is
familiar with your medical history.
2. If you are taking medication, consult with your physician to determine the most
appropriate time to measure your blood pressure. Never change a prescribed
medication without first consulting with your physician.
3. For persons with irregular or unstable peripheral circulation problems due to
diabetes, liver disease, hardening of the arteries, etc., there may be fluctuation in
blood pressure values measured at the upper arm versus at the wrist.
4. This device is designed for adults to use if use this device on a child patient, old
people or toddlers, consult with your physician or measure with relative aid.
5. Measurements may be impaired if this device is use near televisions,
microwave ovens, X-ray mobile phone equipment or other devices with strong
electrical fields. To prevent such interference, use the meter at a sufficient
distance from such devices or turn them off.
6. This device is not suitable for disease diagnoses, urgent treatment, continuous
monitoring during medical emergencies or operations.
7. Before using, should wash your hand.
8. If there is overmuch pressure or you feel uncomfortable, please press
"POWER" button immediately for quick deflation
9. Five minutes should elapse before the first reading is taken.
10. If there are unexpected readings, you should seed an explanation from your
physician.
11. Any reading may be affected by the measuring position, the patient's position,
movement, or the patient's physical condition
12. Failure to use the cuff specified by use manual, or modified instrument may
result in incorrect measurements.
13. If the device is stored in the lowest (-20 ℃ ) or highest temperature (55 ℃ )
environment and measured at the ambient temperature (20 ℃ ), it shall be
placed in the environment for 15 minutes before the measurement.
14. Too frequent blood pressure measurements can lead to unnecessary stress and
elevated blood pressure.
15. Measuring blood pressure in a wound can lead to incorrect measurements and
bacterial infections.
16. Cuff may trigger lymphedema in the upper extremity when used on the arm for
a mastectomy.
17. Pressure on the cuff can temporarily disable monitoring devices that are used
at the same time on the same limb.
18. It is necessary to check whether the operation of the sphygmomanometer will
have a long-term effect on the patient's blood circulation.
19. Continuous compression of the cuff by knotted hoses may result in incorrect
measurements or damage to the patient's skin.
20. Contraindications: serious arteriosclerosis, cardiac pacemaker.
21. Patient is intended operator
22. Pregnant women and preeclampsia patients can’t use this device.
23. When worn on limbs with invasive devices or arteriovenous shunt devices, the
cuff can cause injury to the patient.
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24. There is no allergic reaction to the accessible material on the device;
25. Children are not allowed to operate the device and should not eat any falling
parts;
26. Stop measurement immediately and cut off the power supply when the hose in
the sleeve belt causes neck strangulation, so as to avoid damage to human
body
Few words about blood pressure
Blood pressure is the force exerted on the walls of your blood vessels as blood flows
through them.
Your heart is like a pump. When it contracts, or beats, it sends a surge of blood
through the blood vessels and pressure increases. This is called your systolic
pressure
When your heart relaxes between beats, your blood pressure decreases. This is
called your diastolic pressure.
When a doctor takes your blood pressure, he or she measures both your systolic and
diastolic pressures and records them as numbers. For example, if your blood
pressure reading is 126/76 (126 over 76), your systolic is 126 and your diastolic is
76. The numbers are calculated in millimetres of mercury and recorded as 126/76
mm Hg
These two numbers provide important information about your health. The more
difficult it is for your blood to flow through your blood vessels, the higher both
numbers will be. When blood pressure is consistently above normal it is called
hypertension (High blood pressure).
Please consult your physician to determine if your blood pressure accurately reflects
your actual blood pressure
Your blood pressure changes constantly. Blood pressure fluctuates from day to day
and minute to minute according to your body's needs. For example, when you are
exercising or angry your blood pressure increases, but when you are relaxing or
sleeping your blood pressure decreases. These fluctuations are completely normal.
This blood pressure monitor is especially helpful when tacking changes in your
blood pressure because it travels anywhere and takes just seconds to use.
Factors that may cause the blood pressure to fluctuate
* Breathing
* Exercise
* Mental stress
* Worries
* Environmental and / or temperature change
* Eating
* Urination and bowel movement
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* Talking * Taking a bath
* Drinking alcohol
* Smoking, etc.
Note: One or two readings will not provide a true indication of your normal blood
pressure. It is very important to take regular, daily measurements and to keep
accurate records. In partnership with your doctor, an accurate record of your blood
pressure over a period of time can be a valuable aid in diagnosing and preventing
potential health problems.
The World Health Organization (WHO) developed the following Blood Pressure
Classification. This classification, however, is only a general guideline because
blood pressure varies from person to person according to age, weight, and health
status.
CONSULT YOUR PHYSICIAN TO DETERMINE YOUR NORMAL BLOOD
PRESSURE.
Systolic (mmHg)
Diastolic (mmHg)
Normal
Less than 139
Less than 89
Borderline
140 to 159
90 to 99
Hypertension
More than 160
More than 100
Note: There is not an universally accepted definition of hypotension (low blood
pressure), but a systolic pressure below 99 mmHg is usually regarded as
hypotension
PRODUCT DESCRIPTION
1. Cuff Connector Jack 5. Air Tube (applied part)
2. Setting Button 6. Upper Arm Cuff (applied part)
3. POWER Button 7. LCD display
4. Memory Button
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Install or replace batteries
When the battery symbol appears on the display or nothing is display while inflation
during measurement, you should replace with new batteries.
1. Press the snap hook on the battery cover to open it.
2. Insert four “AA” batteries in the correct polarity direction.
3. Replace the battery cover.
4. With the use of four alkaline “AA” batteries, you can measure approximately 250
times at room temperature of 22℃ and inflating to around 170 mmHg once a day.
But the included batteries only for test purpose may not last as specified long period.
5. When the battery icon “ ” displays on the LCD, please replace four new
batteries, please do not mix the new and old battery together.
6. If the unit will not be used for a long period, please take out all batteries to avoid
liquid leakage damaging the unit.
Environment Protection – Waste electrical products should not disposed of with
household waste. Please recycle where facilities exist. Check with your local
authority or retailer for recycling advice.
How to use the upper arm cuff
1. Pass the end of the cuff (with sewn-in rubber
stopper) through the metal stirrup so that a loop is
formed. The Velcro closer must be facing outwards.
(Ignore this step if the cuff has already been prepared.)
2. Push the cuff over the left upper arm so that the tube
points in the direction of the lower arm and palm.
3. Lay the cuff on the arm as illustrated. Make certain
that the lower edge of the cuff lies approximately 1 to
2 cm (3/4~1") above the elbow and that the rubber
tube leaves the cuff on the inner side of the arm.
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Important! The mark (about 2 cm long bar) must lie exactly over the artery which
runs down the inner side of the arm.
4. Tighten the free end of the cuff and close the cuff
with the closer.
5. There must be no free space between the arm and
the cuff as this would influence the result. Clothing
must not restrict the arm. Any piece of clothing which
does (e.g. a pullover) must be taken off.
6. Secure the cuff with the Velcro closer in such a way
that it lies comfortably and is not too tight. Lay the
arm on the table (palm upwards) so that the cuff is at
the same height as the heart. Make sure that the tube is
not kinked.
7. Remain seated quietly for two minutes before you
begin the measurement.
Note:
1. If it is not possible to fit the cuff to the left arm, it can also be placed on the
right arm. However all measurements should be made using the same arm for
better cross reference;
2. When measuring, the legs should not be crossed, feet flat on the ground, arms
and back vertical.
3. When measuring, do not squeeze the hose of cuff, as this may cause injury or
incorrect measurements.
A few suggestion before measurement
1. Avoid eating, smoking, and exercising for at least 30 minutes before taking a
measurement. Also rest for at least 15 minutes before taking a reading.
2. Stress raises blood pressure. Avoid taking measurements during stressful
times.
3. You would better apply the cuff on your left upper arm.
4. Measurement should be taken in a quiet place and you should be relaxed,
seated position. Rest your left arm on a table.
5. Remain still and do not talk during the measurement.
6. Keep a record of your blood pressure and pulse for your doctor. Remember, a
single measurement does not provide an accurate indication of your true
blood pressure. You need to take and record several measurements over a
period of time. Try to measure your blood pressure at the same time each day
for consistency. Blood pressure measurements fluctuate considerably.
7. Wait 5-10 minutes between successive measurements. Waiting allows the
engorged blood vessels to return to normal. You may require more rest time
depending on your individual physical conditions.
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How to measure blood pressure
1. Set up the cuff to your upper arm as previous section of "How to use the upper
arm cuff".
2. Press the power button, The LCD display and the voice guiding the correct
posture and measurement while the arm cuff start to inflate.
3. During the voice guiding the cuff is fully inflated, it will automatically start to
deflate and the heart symbol will appear to indicate that measurement is in
progress, once the symbol stop flashing and detect systolic, diastolic and pulse
then the voice will announce the measure result.
When the monitor detects an irregular rhythm that varies by less
than 25% from the average rhythm two or more times during the
measurement, the Irregular Heartbeat Symbol will appear on the
display with the measurement values, we recommend you consult
your physician.
Remain still and do not talk during the measurement. Position your arm higher than
the heart will get lower measure result, contrarily the measure result will get higher.
This unit can intelligently adjust the cuff pressure and inflate to a higher pressure
level when needed, so its normal when the unit re-inflate during one measurement.
Note:
The value measured will be too low if you hold your cuff higher than heart
level, or will be too high if you hold your cuff lower than heart level.
The unit may store 10 measurements, if the data more than 10 records, it will
delete the earliest data.
During measurement do not speak or shake as which may affect the accuracy of
the result.
If you want to stop the measurement during measurement process, just press
the power button to stop immediately.
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Recalling memory
1. Press “M” button to turn on the device, then press “M” button until enter
memory state like right figure.
2. Press “M” or “S” button to check the next measurement data.
3. If there is no memory, it will display “—” and then turn off in one second.
How to prevent a malfunction
1. Do not drop the device and avoid sudden jars or shocks.
2. Do not inset other objects into any holes.
3. Do not attempt to disassemble the unit.
4. Do not crush the pressure cuff.
5. If the unit has been stored at temperatures below 0oC, leave it in a warm place for
30 minutes before using it, otherwise, may get wrong measurement result.
Maintenance and repair
1. Do not wash or immerse the unit in water, use a soft and
dry cloth to clean it.
2. Do not use the volatile liquids to clean the main unit or
cuff.
3. Do not moisten the cuff, wash hands before measurement.
4. When the cuff dirty, Wipe on the surface of the cuff with a
cloth moistened with a 70% dilution of isopropyl alcohol or a
80% or less dilution of disinfection ethanol (ethyl alcohol).
Do not allow any liquids inside the cuff. If a liquid gets in the
cuff, dry the inside well.
5. Precision components are used in the construction of this
device. Extremes in temperature, humidity, direct sunlight,
shock or dust should be avoided.
6. The disassemble arm cuff can be store in the storage box.
7. When the unit is on, press the “S” and “M” buttons together for 5 seconds, when
“tst” displays, loose both buttons, the main program version will appear then enter
to the static pressure testing mode, and “DIA” location shows “00”. (Only
professional technician is qualified to operate).
Note: Do not maintain the equipment while it is in use.
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Symbols information
Type BF applied part
Attention and read before use
Indicates the medical device manufacturer
Indicates the authorized representative in the European
community
IP20
Degrees of protection provided by enclosures.
Refer to instruction manual
Please dispose of the device / battery / packing in
accordance with the legal obligation in your area.
Serial number
M
Memory key
S
Set key
ON/OFF and measure key
Specifications
Indication
Digital LCD display
Pressure display Range:
Pressure: 0-300 mmHg, Pulse rate: 40~195 Beat/min
Pressure display Accuracy:
Pressure: ±3mmHg; Pulse rate: ±5%
NIBP measurement range
SYS 60 to 260 mmHg
DIA 30 to 195 mmHg
Pulse rate 40 to 195 /min
NIBP accuracy
Maximum mean error within ±5mmHg
Maximum standard deviation within 8mmHg
Pulse rate accuracy
Within ±5 % of reading
Inflation:
Electric Pump Inflation
Deflation:
Pressure Release Value
Memory:
50 sets
Power Source:
DC 6V, 4*AA (1.5V) battery
Battery Life:
Approx. 250 Charge-Discharge Cycles
Operating Environment Condition
5℃~40℃, RH≤80%, 700hPa~1060hPa
Storage Environment Condition
-20℃~55℃, RH≤93%, 500hPa~1060hPa
Outside Dimensions:
157mm(L)*96mm(D)*64mm(H)
Weight:
Approx. 495g (Apparatus and Battery)
Accessories
Cuff (fit arm size: 22~32cm, rated air pressure:
300mmHg , service life: 18 months), Instruction
manual, Storage Pouch
Service life
5 years
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Troubleshooting
If you have trouble while using the unit, please check the following points first.
ERROR DISPL AY
POSSI BLE CAUS E
HOW TO CORRECT
Nothing is displayed when
you push the POWER button
or “ ” battery icon flash
No battery installation
Insert batteries
Battery worn out
Replace new batteries
The polarities of batteries
placed wrongly
Insert battery in the correct
polarities
E1: The cuff Can't normally
increase pressure
Check your cuff if any air
leakage
Replace wrist cuff with new
one
E0, E2, E7, E8, E9
Measurement failure
Cuff not properly adjust or
placement, hand or body
shaking.
Renew adjust cuff position and
tightness, and keep hand still
E3. Inflate pressure too high
Re-measurement or send back
dealer for re-calibrate pressure
E4: Have shaking while
measurement
Hand or body shaking while
measurement
Keeping static and correct
gesture to measure again
E5: Automatically pressure
release too fast
Cuff too tight
Readjust cuff and measure
again
E6: Automatically pressure
release too slow
Cuff too loose
" " Battery icon on
Battery low power
Replace new battery, and
measure again
The systolic pressure value or
diastolic pressure value too
high
1.The hand with the cuff was
held lower than your heart
Keeping correct position and
gesture to measure again
2.The cuff was not attached
properly
3.You moved your body or
spoke during measurement
The systolic pressure value or
diastolic pressure value too
low
1.The hand with the cuff was
held higher than your heart
2.You moved your body or
spoke during measurement.
EMC statement
This device has been tested and homologated in accordance with EN 60601-1-2 for
EMC. This does not guarantee in any way that the device will not be affected by
electromagnetic interference. Avoid using the device in high electromagnetic
environment.
Recommended separation distances between portable and mobile RF
communications equipment and the 2006-2B Blood Pressure Monitor
The 2006-2B Blood Pressure Monitor is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or
the user of the 2006-2B Blood Pressure Monitor can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the 2006-2B Blood Pressure
Monitor as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum
output power of
transmitter(W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
Pd 2.1
80 MHz to 800 MHz
Pd 2.1
800 MHz to
2.5 GHz
Pd 3.2
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
1001212
23
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
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manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
Guidance and manufacturer’s declaration – electromagnetic emission
The 2006-2B Blood Pressure Monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the device should assure
that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment -
guidance
RF emissions
CISPR 11
Group 1
The 2006-2B Blood Pressure
Monitor 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 B
The 2006-2B Blood Pressure
Monitor is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic
purposes.
Harmonic emissions
IEC/EN61000-3-2
Not applicable
Voltage fluctuations
/flicker emissions
IEC/EN61000-3-3
Not applicable
Guidance and manufacture’s declaration–electromagnetic immunity
The 2006-2B Blood Pressure Monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the device should assure
that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic
environment-guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
8 kV contact
15 kV air
8 kV
contact
15 kV air
Floors should be wood,
concrete or ceramic tile.
If floor are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical Fast
Transient/Burst
IEC/EN61000-4-4
±2kV for power
supply lines
±1kV for
input/output lines
Not
applicable
Not applicable
Surge
IEC/EN61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Not
applicable
Not applicable
Voltage dips, short
interruptions, and
voltage variations
on power supply
input lines
IEC/EN61000-4-11
<5%UT(>95% dip
in UT)
for 0.5cycle
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 5s
Not
applicable
Not applicable
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Power frequency
(50Hz/60Hz)
magnetic field
IEC61000-4-8
30 A/m
30 A/m
Power frequency
magnetic fields should
be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
Guidance and manufacture’s declaration – electromagnetic immunity
The 2006-2B Blood Pressure Monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the device should assure
that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic
environment-guidance
Conducted
RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
3 Vrms
150 kHz ~
80 MHz
6Vrmsc)in
ISM bands
between
0,15 MHz
and 80
MHz
10V/m
3 Vrms
150 kHz to
80 MHz
6Vrmsc)in
ISM bands
between
0,15 MHz
and 80
MHz
10 V/m
80 MHz to
Portable and mobile RF
communications equipment should be
used no closer to any part of the
2006-2B Blood Pressure Monitor,
including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance:
Pd 2.1
150 kHz to 80 MHz
Pd 2.1
80 MHz to 800 MHz
Pd 3.2
800 MHz to 2.7 GHz
d=6 /E at RF wireless
communications equipment bands
(Portable RF communications
80 MHz ~
2.7 GHz
2.7 GHz
equipment (including peripherals such
as antenna cables and external
antennas) should be used no closer
than 30 cm (12 inches) to any part of
the 2006-2B Blood Pressure Monitor,
including cables specified by the
manufacturer).
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the transmitter
manufacturer and d is the
recommended separation distance in
metres (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, a should
be less than the compliance level in
each frequency range. b
Interference may occur in the vicinity
of equipment marked with the
following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
a. Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an
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electromagnetic site survey should be considered. If the measured field strength in
the location in which the 2006-2B Blood Pressure Monitor is used exceeds the
applicable RF compliance level above, the SD1Ultrasonic Doppler should be
observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the
2006-2B Blood Pressure Monitor.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
3 V/m.
c. The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80
MHz are 6,765 MHz to6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to
27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between
0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to
5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz,
18,07 MHz to 18,17 MHz,21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0
MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
FCC Requirement
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
This device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may
cause undesired operation.
Note: This equipment has been tested and found to comply with the limits for a Class
B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential installation.
This equipment generates, uses, and can radiate radio frequency energy, and if not
installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
– Reorient or relocate the receiving antenna.
– Increase the separation between the equipment and receiver.
– Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
– Consult the dealer or an experienced radio/TV technician for help.
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