Biostar Microtech IBP130 Digital Blood Pressure Monitor User Manual Manual

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“i-Kare” Intelligent Blood Pressure
Monitor
Model: iBP-130 / User Manual
Be sure to read this instruction before you use the device.
Ver.0.63 Issue date: 2017/07/28
Table of Contents
Table of Contents ...................................................................................................................... ‐ 1 ‐
Know Your Unit ......................................................................................................................... ‐ 3 ‐
Introduction ................................................................................................................................‐ 6 ‐
Precautions ................................................................................................................................‐ 7 ‐
1. Part Description .................................................................................................................... ‐ 9 ‐
2. Before Start ......................................................................................................................... ‐ 11 ‐
2.1 Battery Installation .......................................................................................................... ‐ 11 ‐
2.2 Setting the Date/Time ..................................................................................................... ‐ 11 ‐
2.3 Fingerprint registration.................................................................................................... ‐ 13 ‐
2.4 Fingerprint recognition .................................................................................................... ‐ 14 ‐
2.5 Delete fingerprint registration......................................................................................... ‐ 14 ‐
3. Take a Measurement ......................................................................................................... ‐ 15 ‐
3.1 Correct Posture ................................................................................................................ ‐ 15 ‐
3.2 Applying the Arm Cuff ..................................................................................................... ‐ 16 ‐
3.3 Take a Measurement ....................................................................................................... ‐ 17 ‐
3.4 Manual Inflate Function .................................................................................................. ‐ 18 ‐
3.5 Review record .................................................................................................................. ‐ 19 ‐
4. How to Transmit Data ........................................................................................................ ‐ 21 ‐
4.1 Wireless transmission .................................................................................................. ‐ 21 ‐
5. Care and Maintenance ...................................................................................................... ‐ 22 ‐
6. Error Indicators and Troubleshooting .............................................................................. ‐ 23 ‐
6.1 Error Indicators ................................................................................................................ ‐ 23 ‐
6.2 Troubleshooting............................................................................................................... ‐ 25 ‐
7. Specifications ...................................................................................................................... ‐ 26 ‐
‐1‐
8. Main Functions .................................................................................................................... ‐ 27 ‐
Appendix I ................................................................................................................................‐ 30 ‐
Appendix II ............................................................................................................................... ‐ 37 ‐
Appendix III .............................................................................................................................. ‐ 39 ‐
‐2‐
Know Your Unit
Warranty
This blood pressure monitor is warranted for 1 year from the date of purchase. This warranty
includes the device only. The warranty does not apply to damages caused by improper
handling, damages from leaking batteries, accidents, failure to follow the instructions or
alterations made to the instrument by third parties.
Intended Use
This blood pressure monitor is intended for home use as well as ambulance. It is not suggested
to be used in public space. It is non-invasive, meaning no part of the monitor enters your body.
It provides systolic pressure, diastolic pressure and pulse measurements. This monitor is
recommended to be used by people over the age of 18 (including pregnant patients) and patient
population with arm circumference ranging from 9" to 13". Neonatal and pediatric patients are
not recommended to use this monitor.
The iBP-130 comes with the following accessory:
Arm Cuff
※Skin irritation or sensitivity may occur due to prolonged exposure to the applied part or rubber latex.
‐3‐

Council Directive: 93/42/EEC M5 as amended by 2007/47/EC

The device complies with R&TTE directive.

ISO 9001:2008; Quality management Systems – Requirement.

ISO 13485:2003; Medical devices – Quality management systems – Requirements for regulatory
purposes.

EN ISO 14971:2012; Medical devices – Application of risk management to medical devices.

EN 980:2008; Graphical symbols for use in the labeling of medical devices.

EN 60601‐1:2006+A1:2013; Medical electrical equipment, Part1: General requirements for safety.

EN60601‐1‐2:2015; Medical electrical equipment – Part1‐2 General requirements for
safety‐collateral standard: Electromagnetic compatibility‐requirements and test.

EN 60601‐1‐6:2010+A1:2015; Medical electrical equipment ‐‐ Part 1‐6: General requirements for
basic safety and essential performance - Collateral standard: Usability.

EN60601-1-11:2015; Medical electrical equipment -- Part 1-11: General requirements for basic
safety and essential performance - Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment.

EN 1060-3:2009; Non-invasive sphygmomanometers - Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring systems.

EN 1060-4:2004; Non-invasive sphygmomanometer.

ISO10993-1:2009; Biological evaluation of medical devices - Part 1: Evaluation and testing within
a risk management process (ISO 10993-1:2009).

ISO10993-5:2009; Biological evaluation of medical devices test for in vitro cytotoxicity.

ISO10993-12:2009; Biological evaluation of medical devices - Part 12: Sample preparation and
reference materials.

ISO10993-10:2010; Biological evaluation of medical devices - Part 10: Test for irritation and skin
sensitization.

EN 300 328(2006-10); Radio and telecommunications terminal equipment.

EN 62366:2008+A1:2015; Application of usability engineering to medical devices

EN 62304:2006+A1:2015; Software life-cycle processes
‐4‐
Distributor
BIOSTAR MICROTECH INTERNATIONAL CORP.
3F., 108-2, Min Chuan Rd., Hsin Tien Dist., New Taipei City, Taiwan (R.O.C.)
Tel: 886 2 2218-0150
EU representative
Manufacturer
BIOSTAR MICROTECH INTERNATIONAL CORP.
3F., 108‐2, Min Chuan Rd., Hsin Tien Dist.,
New Taipei City, Taiwan(R.O.C)
Biostar Microtech Netherlands BV
Archimedesweg 2A, 5928PP Venlo,
The Netherlands
Read this manual
before use.
Type BF Applied part
‐5‐
Introduction







Before operating this monitor, please carefully read the instruction to use it
correctly.
This product is designed for blood pressure monitoring and applied to
adults. It is not applied to neonates and infants.
This device complies with IEC 60601-1 standard for medical products.
The device uses digital pressure sensor to measure blood pressure. It
applies to high altitude or low altitude environment, and is equipped with
auto-correction function.
It is designed with a large LCD display as a result the elderly and visually
impaired are able to read the measurements.
The monitor not only recognizes five users with their own fingerprints but also
stores up to 200 individual measurements.
The monitor passed IP22 test. The first 2 means " the level of protection that
the enclosure provides against access to hazardous parts and the ingress of
solid foreign objects larger than 12.5 mm " and the second 2 means
“vertically dripping water shall have no harmful effect when the enclosure is
tilted at an angle of 15° from its normal position. A total of four positions are
tested within two axes. ” (https://en.wikipedia.org/wiki/IP_Code)
‐6‐
Precautions
Warning: Do not use the product for any purpose other than measuring blood pressure.
Warning: This product is designed for use by adults. Do not use on neonatal and infants.
Warning: People suffering from a serious problem of blood flow, vascular disease or pregnant woman should
consult their physician before measuring their blood pressure themselves.
Warning: Do not use the product in presence of flammable gases to avoid explosion.
Warning: To avoid electric shock, not attempt to disassemble the product except for battery cover. Only trained and
authorized personnel can repair, replace or adjust the machine.
Warning: Do not let this product to be used by children or people who cannot express their feelings.
Warning: If you can not determine the accuracy of the measurement value. Please confirm by other monitoring
methods.
Warning: Do not use this product in MRI or high electromagnetic radiation environment.
Warning: Measurements may be affected if the device is used close to televisions, microwave oven, X-ray
equipment or other devices with strong electrical fields. Measure blood pressure at a sufficient distance from such
devices or switch them off.
Warning: Any affecting the blood flow act will cause incorrect measurement values.
Warning: Clean the monitor and cuff with a dry, soft cloth or a cloth dampened with water and a mild detergent.
Never use benzene, thinner or other harsh chemicals to clean monitor or cuff.
Warning: If you fold the arm cuff excessively or bend the tube for a long time. It might shorten the lifetime of the
main unit or accessories.
Warning: The product is not water-proof. Do not submerge the device in water or use it in raining or high humidity
environment.
Warning: Avoid using the device in extreme temperatures, humidity, direct sunlight, dust or vibration environment.
Do not shock or drop the device.
Warning: When removing the air tube, pull on the air plug at the connection with the main unit not the tube itself.
Warning: Only install 4 “AA” batteries. Do not use different types of batteries.
Warning: Do not use different brands or mixing new and old batteries in one device.
Warning: If the battery leakage occurs, it will damage the main unit.
Warning: If the product will not be used for a long time (3 months or more ), remove the batteries.
Warning: A warning that other accessories may negatively affect EMC performance.
Warning: A warning regarding stacking and location close to other equipment.
Warning: A warning that use of other accessories results in non-compliance.
Warning: Use the other arm if patient’s left arm is used for monitoring or patient’s left side happened mastectomy.
Warning: Do not be too frequent measurement of blood pressure, to avoid blood vessels and tissue damage.
‐7‐
Please be aware that the cuff and its pressurization may cause temporary intererence to blood flow and injury to
the patient.
Disposal: Follow the national requirement to dispose unit.
‐8‐
1. Part Description
Main Unit
Battery
Power
Compartment
Menu
Up
Down
Start
LCD Display
Air Jack
‐9‐
Arm Cuff
LCD Display
Heartbeat / Irregular
heartbeat Symbol
Systolic Blood
Pressure
Body Motion
Symbol
Record
Symbol
Diastolic Blood
Pressure
Transmission
Symbol
Pulse
Pumping/Leaking
Air Symbol
Finger Print
Indicator
Bar Symbol
Battery
Indicator
Date/Time
‐ 10 ‐
2. Before Start
2.1 Battery Installation
1.
Make sure the monitor is switched off and turn the main unit over (battery
compartment up).
2.
Remove the battery cover.
3.
Install 4 “AA” size batteries so the + (positive) and - (negative) polarities match the
polarities of the battery compartment as indicated.
4.
Replace the battery cover.
5.
Please note that batteries are the only power source in the device. No other power
source, such as adaptor, is acceptable.
After replacing the battery, you may need to reset the time and date.
4 new batteries allow users to measure your blood pressure for proximately 1000 times.
Please dispose the batteries to the local recycle unit.
2.2 Setting the Date/Time

The time setting is for 24-hour clock.

Press “Up” to increase the value; press “Down” to decrease the value.

Press and hold “Up” or “Down” to increase or decrease the values faster.

Use “Menu” to move to year, month, date and time. Once it is selected, it will flash on
the display.

If the dedicated APP is connected to the monitor, the time and date will be
auto-calibrated.
‐ 11 ‐
1.
Press "Power" to turn on the monitor. Then press “Menu” three times and you will see
"year" flash on the bottom of the display.
Press “Menu”
three times
2.
Please press “Up” or “Down” to select the correct “Year.”
3.
After setting “Year”, press “Menu” to save the change and move to “Month”. Now you
shall see "Month" flashing on the display. Please press “Up” or “Down” to change the
value.
4.
After setting “Month”, press “Menu” to save the change and move to “Date”. Now you
shall see "Date" flashing on the display. Please press “Up” or “Down” to change the
value.
5.
Please press “Menu” to save the change and move to “Time”. Now you shall see
"Time" flashing on the display. Please press “Up” or “Down” to change the value.
6.
Please press “Menu” to save the change.
7.
When completed, please press “Power” to turn off the monitor.
8.
If you wish to leave Date / Time setting at any point, please press “Power” to turn off
the monitor.
‐ 12 ‐
2.3 Fingerprint registration

This monitor is designed to recognize up to 5 fingerprints.

Press and hold “Power " at least 3 seconds. Press "Menu" once and
symbol will
be illuminated then place your finger in the finger print receptor.

If this particular finger has not been registered, the display will show P_ and that means
you can select your user ID by pressing "Up / Down".
Use “Up” or “Down”
Button to select users

Once you select your user ID, press "Start" to confirm it. Then the first box of the bar is
illuminated (
) and please place your finger in the finger print receptor. Remove your
finger when the firs box of the bar is flashing.

When the second boxes of the bar is illuminated (
), please place your finger in the
finger print receptor. Remove your finger when the second boxes of the bar is flashing.

When the third boxes of the bar are illuminated (
) and please place your finger in the
finger print receptor. Remove your finger when the third boxes of the bar is flashing.
‐ 13 ‐

When the user ID and
symbol are flashing on the display, the settings is
completed and press “Power” to exit.
Please note, if the finger has been registered, the display will show you user ID
associated with that finger.
Please note that the display will only show available user IDs, which means if
someone has been measuring his / her blood pressure under a particular user ID, the
display will not show this ID.
2.4 Fingerprint recognition

The monitor needs to recognize your fingerprint in order to proceed certain functions,
such as deleting fingerprint registration.

To recognize your fingerprint, please turn on the monitor. When
symbol is
illuminated, place your registered finger in the finger print receptor. Your user ID will be
shown on the display.
2.5 Delete fingerprint registration

If you wish to delete your registered fingerprint, please be aware that your records will
be deleted as well.

Press and hold "Power" at least 3 seconds, then press "Menu" twice and
symbol
on will be illuminated.

Then place your registered finger in the finger print receptor. The display will show
"dEL" and your user ID.

If you wish to continue the deletion, press "Start" to confirm it.
symbol will be
flashing and deletion of both your registered fingerprint and your measurement records
is successful. Then press “Power” to exit.
‐ 14 ‐
3. Take a Measurement
To avoid damage of vessels and tissue, do not frequently measure blood pressure.
3.1 Correct Posture

Before being the measurement, please ensure you are relaxed as much as possible.
We recommend that users should rest for at least 5-minute before the measurement.

Rest your left arm on a table and relax your arm as shown below. To avoid errors,
please maintain the correct posture during the measurement

Make sure the cuff is at your heart level. When measuring blood pressure, lightly
bend your elbow while resting your arm on a table. If the level of the arm cuff is lower
than your heart, please place a cushion under your arm.

Improper posture will affect the results of the measurements, such as: loose arm cuff,
talking during measurement, body tilted, or sitting cross-legged.
‐ 15 ‐
3.2 Applying the Arm Cuff
Please ensure there is no wound on your arm to avoid further injury by cuff being over it.
Remove constricting clothing and place cuff on bare left upper arm without impeding the blood
flow. Ensure there is no barrier around arm cuff and follow the figure below to apply the arm cuff
correctly.

Fasten the arm cuff on the left upper arm and exhaust air out form arm cuff to avoid
error.

The air tube should parallel with your arm and align the mark”
” to your brachial
artery, as shown below.

Fasten the arm cuff on the left upper arm and exhaust air out form arm cuff to avoid
error.
After measurement, please leave the cuff at the place where children can not
reach to avoid strangulation and choking by cable and small parts.
‐ 16 ‐
3.3 Take a Measurement

Please keep correct posture and press “Power”.
symbol will be flashing and
you may place your registered finger in the finger print receptor.



The display will show your user ID and press "Start" to begin the measurement.
When it is finished, your measured value will appear on the display.
Please note, if your registered finger is injured or you are unable to place it in the
finger print receptor for any reasons, you may use "Up / Down" to select your user
ID.

If your friends wish to try the monitor but do not wish to register their fingers, please
press " Power” and "Start" to being the measurement. Their measurement values will
be recorded under user ID P0.
“Power”
‐ 17 ‐
3.4 Manual Inflate Function
If your systolic pressure is known to be more than 220 mmHg please follow procedures. Press
and hold the “Up" button to enter “Manual Inflate” mode before the cuff inflated to 180mmHg.
When cuff pressure reaches 290 mmHg, the cuff will be deflating and measurement starts.
If you do not wish to inflate to 290mmHg, you can release “Up" during the inflating process. The
air will be leaking and measurement starts.
When the cuff is inflated to 180mmHg,
press and hold the “Up" button to enter
“Manual Inflate” mode.
‐ 18 ‐
3.5 Review record

Press "Power" to turn on the monitor. When
symbol flashes and you may place
your registered finger in the finger print receptor.

Your user ID will be shown on the display. Press “Menu” once and wait for a second
to enter “Review Mode”.
1.
The symbol "
" will be shown on the display. Now you may select your own
record by pressing "Up" or "Down".
2.
The display will show your systolic and diastolic values, as well as your pulse.
3.
If you see “
” or “
”, that means irregular heartbeat or body movement are
detected during the measurement.
Press “Menu”
once
‐ 19 ‐
Press “Up” or “Down” to
select the records.
4.
If you wish to exit the “Review Mode”, please press “Power” to exit.
‐ 20 ‐
4. How to Transmit Data
4.1 Wireless transmission

To transmit data wirelessly, please install APP on your tablet or smart phone. After
turn on blood pressure monitor and press "Menu" once, the symbol "
" will be
appeared on the display.
 Then turn on APP and press
. It will then search Bluetooth from the monitor.
Once Bluetooth is detected, the Bluetooth address will appear on APP . Please
press

Please press
on APP and "
" will appear on the display on the monitor.
on APP and it will start transmit all data from the monitor to APP.
‐ 21 ‐
5. Care and Maintenance
To keep your intelligent blood pressure monitor in the best condition and protect the product from
damage, follow the directions listed below:

Do not subject the main unit to extreme hot or cold temperatures, humidity or direct sunlight.

Do not forcefully fold the arm cuff or air tube.

Do not disassemble or attempt to repair the product or components.

Do not subject the monitor to strong shocks, such as dropping the product on the floor.

Do not spill the water on the main unit and cuff arm, or immerse them in water.

Do not use volatile liquids to clean the main unit. Cleaning the main unit with a soft & dry
cloth.

Use 75% alcohol cotton to wipe the main unit if the monitor is transferred to another patient.

Do not use petrol, thinners or similar solvents to clean the arm cuff.

Do not try to repair the product by yourself. If you have any problems, such as setting up,
maintaining or using, please contact Biostar. Do not open or repair the device by yourslef.

Clean the monitor and cuff with a dry, soft cloth or a cloth dampened with water and a mild
detergent after the measurement.
‐ 22 ‐
6. Error Indicators and Troubleshooting
6.1 Error Indicators
Error code
Cause
Correction
E01
Severe body movement during
measurement.
Repeat measurement. Remain still
and do not talk during measurement.
Refer to “Taking a Measurement”.
E02
Arm cuff not applied correctly;
arm cuff connects the main unit
incorrectly.
Apply the arm cuff correctly. Refer to
“Applying the Arm Cuff”.
Air tube connects the main unit
incorrectly.
Insert the plug securely. Refer to
Applying the Arm Cuff”.
Air is leaking from the arm cuff.
Replace the cuff with the new one.
The motor or deflating valve is
fail.
Please contact distributor.
E04
The arm cuff was inflated above
300 mmHg
The main unit will stop pumping and
leak air. Please turn off the main unit
and restart it.
E05
Sensor malfunction
Please turn off the main unit and
restart it.
E06
Batteries are low but still are able
for certain functions.
Replace new batteries. Refer to
“Battery Installation.”
E07
Data transmission malfunction
Please reconnect and transmit data.
E03
‐ 23 ‐
Error code
Cause
E08
When systolic or diastolic
pressure is over than 230 mmHg
or is less than 40 mmHg.
Measure blood pressure with other
device.
Batteries are worn out.
Replace new batteries. Refer to
“Battery Installation.”
‐ 24 ‐
Correction
6.2 Troubleshooting
Problem
Cause
No power.
No battery
No display appears on
the product.
Wrong battery polarity
Solutions
Replace the four batteries. Refer to
“Battery Installation.”
Batteries are worn
The cuff does not inflate.
The air pressure cannot
rise.
Batteries are worn
Replace the four batteries. Refer to
“Battery Installation.”
Arm cuff connects the main unit
incorrectly.
Apply the arm cuff correctly. Refer to
“Applying the Arm Cuff”.
Air is leaking from the arm cuff.
Replace the cuff with the new one.
The motor or deflating valve is
fail.
Please contact distributor.
Arm cuff connects the main unit
incorrectly.
Apply the arm cuff correctly. Refer to
“Applying the Arm Cuff”.
Air is leaking from the arm cuff.
Replace the cuff with the new one.
 Please turn off the main unit and
restart it.
Sensor malfunction
Measurement values
appear too high or too
low.
Others
 Contact customer service for repair
information.
Roll up shirt sleeves causes arm
blood circulation not smooth.
Take off or release the clothes which
press your arm. Apply the arm cuff
correctly again.
Improper posture during
measurement
Remain still and do not talk during
measurement.
Wrong arm cuff position
Apply the arm cuff correctly. Refer to
“Applying the Arm Cuff”.
Weak signal or cardiovascular
disease
People suffering from cardiac
arrhythmia, people with vascular
surgery or a weak pulse may have
incorrect measure values.
The system is failed or crash.
Replace the batteries and restart the
main unit.
‐ 25 ‐
7. Specifications
Model
i-Kare iBP-130 Intelligent blood pressure monitor3
Display
LCD digital display
Measuring method
Oscillometric system
Pumping Pressure: 0 to 290 mmHg
Pressure range
Measuring Pressure: At Least 40-230 mmHg
Measuring pulse rate range
Pulse rate: 40 to180 pulses / min
Accuracy
Pressure: ± 3 mmHg of pressure
Pulse rate:± 3 bpm or ± 5% of reading value
Inflation
Automatic by electric pump
Deflation
Automatic electrical valve
Pressure sensor
Digital pressure sensor
Data transmission
Wireless
Power source
AA Battery x4
Time maintain function
After time/date setting, the record will maintain for 4 hours without batteries.
Operating
+10 to +40℃, 30 to 85％ relative humidity ( no condensation)
Temperature/Humidity
Storage and Transportation
-20 to +60℃, 10 to 95％ relative humidity ( no condensation)
Temperature/Humidity
Operating
700 hPa~1060 hPa
Atmospheric pressure
Measure range of arm
230 ~ 330 mm (9”~13”)
Weight
Approx. 517.5 g（including batteries)
Dimensions
130(W) x160(L) x 85(H) mm
Contents
“AA” Alkaline batteries x4, Arm Cuff x1, User Manual x1
BIOSTAR MICROTECH INTERNATIONAL CORP.
3F., 108-2, Min Chuan Rd., Hsin Tien Dist., New Taipei City, Taiwan(R.O.C)
Tel: 886 2 2218-0150
Manufacturer/Distributor
Remark
Measuring blood pressure range (at least): 40 mmHg ~ 230 mmHg
‐ 26 ‐
8. Main Functions
1. It provides five users for blood pressure measurement and management.

The finger print receptor will identify users' IDs or simply press “Up” or “Down” to select
IDs. The user IDs are P1, P2, P3, P4, and P5. After setting completed, please press
“Power” to exit.
2. The blood pressure monitor stores up to 200 individual measurement values.

Press “Menu” button and wait 1 second to enter "Review records". Press “Up” or “Down”
to select data. After completing, press “Power" to exit.
3. Time/Date setting

Press the “Menu” button twice to enter this function. Use the “Menu” button to select
the year, month, date and time. Press “Up” or “Down” to increase or decrease the
values. After completing, press “Power” to exit.
4. Automatic power detection, low battery indicator

When low battery, the “Low Battery” symbol will appear on the display
5. Automatic shutdown

If there is no operation for 1 minute, the monitor will automatically turn off.
6. Time maintain function

After time/date setting, the record will maintain for 4 hours without batteries.
7. Physiological parameter measurement


Blood pressure measurements: systolic and diastolic blood pressure
Heartbeat measurement
‐ 27 ‐
9. Basics of Blood Pressure
What is blood pressure?
Blood pressure is a measure of the force of blood flowing against the walls of the arteries. Arterial
blood pressure is constantly changing during the course of the heart’s cycle. The highest pressure
in the cycle is called the Systolic Blood Pressure; the lowest is the Diastolic Blood Pressure. Both
pressure readings, the Systolic and Diastolic, are necessary to enable a doctor to evaluate the
status of a patient’s blood pressure.
Why is it a Good Thing to measure Blood Pressure at Home?

Having your blood pressure measured by a doctor can cause anxiety which is itself a
cause of high blood pressure. As a variety of conditions affect blood pressure, a single
measurement may not be sufficient for an accurate diagnosis.

Many factors such as physical activity, anxiety, or the time of day, can influence your
blood pressure. Thus it is best to try and measure your blood pressure at the same
time each day, to get an accurate indication of any changes in blood pressure.

Blood pressure is typically low in the morning and increases from afternoon to evening.
It is lower in the summer and higher in the winter.

Blood pressure is measured in millimetres of mercury (mmHg) and measurements are
written with the systolic pressure before the diastolic e.g. A blood pressure written as
135/85, is referred to as 135 over 85 mmHg.
Classification of Blood Pressure by the World Heath Organization
The World Health Organization (WHO) and the International Society of Hypertension (ISH)
developed the Blood Pressure Classification shown in this figure.
This classification is based on the blood pressure values measured on people in a sitting position
in outpatient departments of hospitals. There is no universally accepted definition of hypotension.
However, those having the systolic pressure below 100 mmHg are assumed as hypotensive.
‐ 28 ‐
High Blood Pressure
High Blood Pressure, or hypertension, is a medical condition in which the arterial blood
pressure is elevated. High blood pressure can be classified as "primary", meaning that no
medical cause can be found, or as "secondary", meaning that it is caused by other conditions
that affect the kidneys, arteries, heart or endocrine system.
Persistent high blood pressure is a risk factor for conditions such as stroke, heart failure, arterial
aneurysm and others. It is also a leading cause of chronic kidney failure. Even moderately
elevated blood pressure for an extended period of time may short your life expectancy.
A person's blood pressure is constantly changing. Blood pressure can fluctuate considerably
through the course of a single day, and it is also affected by the seasons and by the weather.
One or two readings are not sufficient to get an accurate picture of your blood pressure.
Ideally, you should get into the habit of checking your blood pressure at fixed times several
times a day, every day, and keep a detailed record of these readings.
This record can then be reviewed by your doctor or other health care provider, helping you to
monitor your health on an ongoing basis.
For a normal, healthy person blood pressure fluctuates within a range of approximately ± 10
mmHg.
‐ 29 ‐
Appendix I
Manufacturer’s declaration-electromagnetic immunity
The iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) is intended for use in the
electromagnetic environment (for home healthcare) specified below.
The customer or the user of the iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) should
assure that it is used in such an environment.
Immunity test
IEC 60601
Compliance level
test level
Electromagn
etic
environmentguidance
(for home
healthcare
environment)
Electrostatic
Contact:±8 kV
Contact:±8 kV
Floors should
discharge(ESD) IEC
Air±2 kV,±4 kV,±8 kV,±15 kV
Air±2 kV,±4 kV,±8 kV,±15 kV
be wood,
61000-4-2
concrete or
ceramic tile. If
floors are
covered with
synthetic
material, the
relative
humidity
should be at
least 30%
Electrical fast
+ 2kV for power supply lines
Not applicable
Mains power
transient/burst IEC
+ 1kV for input/output lines
Not applicable
quality should
61000-4-4
be that of a
typical home
healthcare
environment.
Surge IEC 61000-4-5
+ 0.5kV, +1kV line(s) to line(s)
Not applicable
Mains power
+ 0.5kV, +1kV,+ 2kV line(s) to
Not applicable
quality should
‐ 30 ‐
earth
be that of a
typical home
healthcare
environment.
Voltage Dips, short
Voltage dips:
Voltage dips:
Mains power
interruptions and
0 % UT; 0,5 cycle
Not applicable
quality should
voltage variations on
0 % UT; 1 cycle
Not applicable
be that of a
power supply input
70 % UT; 25/30 cycles
Not applicable
typical home
healthcare
lines IEC 61000-4-11
Voltage interruptions:
Voltage interruptions:
environment.
0 % UT; 250/300 cycle
Not applicable
If the user of
the iBP-130,
iBP-131,
iBP-132,
iBP-133,
iBP-143,
iBP-1XX(XX=
0-9) requires
continued
operation
during power
mains
interruptions,
it is
recommended
that the
iBP-130,
iBP-131,
iBP-132,
iBP-133,
iBP-143,
iBP-1XX(XX=
0-9) be
powered from
an
uninterruptible
‐ 31 ‐
power supply
or a battery.
Power frequency(50,
30 A/m
30 A/m
The iBP-130,
60 Hz) magnetic field
50 Hz or 60 Hz
50 Hz, 60 Hz
iBP-131,
IEC 61000-4-8
iBP-132,
iBP-133,
iBP-143,
iBP-1XX(XX=
0-9) power
frequency
magnetic
fields should
be at levels
characteristic
of a typical
location in a
typical home
healthcare
environment.
NOTE
UT is the a.c. mains voltage prior to application of the test level.
‐ 32 ‐
Manufacturer’s declaration-electromagnetic immunity
The iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) is intended for use in the electromagnetic
environment (for home healthcare) specified below.
The customer or the user of the iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) should assure
that is used in such and environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment-guidance
(for home healthcare environment)
Conducted RF
3 Vrms:
IEC 61000-4-6
0,15 MHz – 80 MHz
6 Vrms:
Not applicable
Portable and mobile RF
communications
Not applicable
equipment should be used no closer to
in ISM and amateur
any part of the iBP-130, iBP-131,
radio bands between
iBP-132, iBP-133, iBP-143,
0,15 MHz and 80 MHz
iBP-1XX(XX=0-9) including cables, than
the recommended separation distance
80 % AM at 1 kHz e)
calculated from the equation applicable to
the frequency of the transmitter.
Radiated RF
10 V/m
10 V/m
IEC 61000-4-3
80 MHz – 2,7 GHz b)
80 MHz – 2,7 GHz
80 % AM at 1 kHz c)
80 % AM at 1 kHz
Recommended separation distance:
d = 1,2 √P
d = 1,2 √P
80MHz to 800 MHz
d = 2,3 √P
800MHz to 2,7 GHz
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:
‐ 33 ‐
NOTE1
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
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 electromagnetic
site survey should be considered. If the measured field strength in the location in which the iBP-130, iBP-131,
iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) is used exceeds the applicable RF compliance level above, the
iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting
or relocating the iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9).
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
‐ 34 ‐
Recommended separation distance between
portable and mobile RF communications equipment and the iBP-130, iBP-131, iBP-132, iBP-133,
iBP-143, iBP-1XX(XX=0-9)
The iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) is intended for use in an
electromagnetic environment (for home healthcare) in which radiated RF disturbances are controlled.
The customer or the user of the iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the iBP-130, iBP-131, iBP-132, iBP-133, iBP-143,
iBP-1XX(XX=0-9) as recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to frequency of transmitter
Rated maximum
output power of
transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,7 GHz
d =1,2√P
d =1,2√P
d =2,3√P
0,01
N/A
0,12
0,23
0,1
N/A
0,38
0,73
N/A
1,2
2,3
10
N/A
3,8
7,3
100
N/A
12
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 manufacturer.
NOTE1
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
‐ 35 ‐
Manufacturer’s declaration-electromagnetic immunity
Test specifications for
ENCLOSURE PORT IMMUNITY
to RF wireless communications equipment
The iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) is intended for use in the electromagnetic
environment (for home healthcare) specified below.
The customer or the user of the iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) should assure
Test
Band a)
frequency
(MHz)
(MHz)
385
450
870
930
1 720
1 845
1 970
2 450
5 785
b)
Compliance
LEVEL
(V/m)
(for home
healthcare)
1,8
0,3
27
27
GMRS 460,
FRS 460
FM c)
±5 kHz
deviation
1 kHz sine
0,3
28
28
704 –
787
LTE Band
13,
17
Pulse
modulation b)
217 Hz
0,2
0,3
0,3
28
28
0,3
28
28
0,3
28
28
0,2
0,3
GSM
800/900,
Pulse
TETRA
800 –
modulation b)
800,
960
18 Hz
iDEN 820,
CDMA 850,
LTE Band 5
GSM 1800;
CDMA
1900;
Pulse
1 700 –
GSM
modulation b)
1 990
1900;
217 Hz
DECT;
LTE Band 1,
Bluetooth,
WLAN,
Pulse
2 400 –
802.11
modulation b)
b/g/n,
2 570
217 Hz
RFID 2450,
LTE Band 7
5 240
5 500
Modulation
IMMUNITY TEST
Distance
LEVEL
(m)
(V/m)
430 –
470
780
810
a)
Pulse
380 –390 TETRA 400 modulation b)
18 Hz
710
745
Service
Maximum
power
(W)
5 100 –
5 800
WLAN
802.11
a/n
Pulse
modulation b)
217 Hz
NOTE
If necessary to achieve the IMMUNITY TEST LEVEL , the distance between the transmitting
antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is
permitted by IEC 61000-4-3.
a)
b)
c)
For some services, only the uplink frequencies are included.
The carrier shall be modulated using a 50 % duty cycle square wave signal.
As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while
it does not represent actual modulation, it would be worst case.
‐ 36 ‐
Appendix II
FCC warning statement
15.21 Federal Communications Commission (FCC) Statement
The user manual or instruction manual for an intentional or unintentional radiator shall caution
the user that changes or modifications not expressly approved by the part responsible for
compliance could void the user’s authority to operate the equipment.
You are cautioned that changes or modifications not expressly approved by the part
responsible for compliance could void the user’s authority to operate the equipment.
15.105(b) Federal Communications Commission (FCC) Statement
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.
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 of the device.
‐ 37 ‐
FCC RF Radiation Exposure Statement:
This Transmitter must not be co-located or operating in conjunction with any other antenna or
transmitter.
RF Exposure:
“For body worn operation, this device has been tested and meets FCC RF exposure guidelines
when used with an accessory that contains no metal and that positions the device a minimum of
5mm from the body. Use of other accessories may not ensure compliance with FCC RF
exposure guidelines.”
15.105(b) Information of the responsible party for a DoC product
The identification of the product:This blood pressure monitor is intended for home use as well
as ambulance.
Product Name: Intelligent Blood Pressure Monitor
Model: iBP-130
Technical Support: Jian Bang Lee
Address:2F, No108-2, Min Chuan Road, Hsin Tien Dist. New Taipei City 231, Taiwan
Telephone: + 886 2 2218 0150
Fax: +886 2 2218 1552
e-mail: banglee@biostar.com.tw
SAR Exposure
This device has been tested for compliance with FCC RF Exposure (SAR) limits in typical
laptop configurations.
In order to comply with SAR limits established in the ANSI C95.1 standards, it is recommended
when using a PC card adapter that the integrated antenna is positioned more than 2.5cm from
your body or nearby persons during extended periods of operation. If the antenna is positioned
less than 2.5cm from the user, it is recommended that the user limit the exposure time.
Prohibition of co-location
This device must not be co-located or operating in conjunction with any other antenna or
transmitter.
‐ 38 ‐
Appendix III
NCC Warning Statement
根據NCC低功率電波輻射性電機管理辦法規定:
第十二條
經型式認證合格之低功率射頻電機，非經許可，公司、商號或使用者均不得
擅自變更頻率、加大功率或變更原設計之特性及功能。
第十四條
低功率射頻電機之使用不得影響飛航安全及干擾合法通信；經發現有干擾現
象時，應立即停用，並改善至無干擾時方得繼續使用。
前項合法通信，指依電信法規定作業之無線電通信。
低功率射頻電機須忍受合法通信或工業、科學及醫療用電波輻射性電機設備
之干擾。
‐ 39 ‐

---

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