EN
Instruction for use
PRO-39
Automatic Blood Pressure Monitor
EN
1. INTRODUCTION
Thank you for purchasing the B.Well Wrist Blood Pressure Monitor
PRO-39. Designed for convenient and easy operation, this device
provides fast and reliable measurement of systolic and diastolic
blood pressure as well as heart rate using the oscillometric
measurement method.
The PRO-39 is a fully automatic, digital, wrist blood pressure
measuring device.
Intended use:
The Blood Pressure Monitor PRO-39 including
accessories is a non-invasive blood pressure measurement system
intended to measure the diastolic and systolic blood pressures
and pulse rate of an adult individual by using the oscillometric
measurement method.
Application area:
for use by medical professionals or at home.
Important advantages of PRO-39:
Up-to-date IntellectClassic technology uses oscillometric
measurement during deflation for quick, precise and painless
result.
The Pulse Arrhythmia Detection technology.
Last measurement memory.
This device has been proven in clinical studies to provide
excellent accuracy.
2. CLASSIFICATION OF BLOOD PRESSURE VALUES
Table for classifying blood pressure values (mmHg) according
to European Society of Hypertension (ESH)
Range
Systolic
blood
pressure
Diastolic
blood
pressure
Measures
Grade 3: severe
hypertension
Higher or
equal to
180
Higher or
equal to 110
Urgently seek
medical advice!
Grade 2: moderate
hypertension
160-179
100-109
Consult your doctor
immediately
Grade 1: mild
hypertension
140-159
90-99
Consult your doctor
High normal
130-139
85-89
Consult your doctor
Normal
Lower than
130
Lower than
85
Self-check
Optimal
Lower than
120
Lower than
80
Self-check
NOTE:
Show the measured values to your doctor. Never use
the results of your measurements to change the doses of
drugs prescribed by your doctor.
3. CONTENTS AND DISPLAY INDICATORS
Model PRO-39
Systolic Pressure
Diastolic Pressure
Pulse Rate
Cuff
Start button
LCD Display
Heart beat symbol
Self-adjustment before measurement
Low battery symbol
Pulse Arrhythmia Detection symbol
4. CONTRAINDICATION
Do not use the device if there is a skin surface damage on the wrist.
It is inappropriate for people with serious arrhythmia to use this
device.
5. PRECAUTIONS
1. Read all of the information in the instruction for use before
operating the unit.
2. Stay still, calm and rest for 5 minutes before blood pressure
measurement.
3. The cuff should be placed at the same level as your heart.
4. During measurement, neither speak nor move your body and
arm.
5. Measuring on both arms for each measurement. Hereafter
measurement should be done on the arm where the blood
pressure is higher.
6. Please always relax about 5 minutes between measurements
to allow the blood circulation in your arm to recover. Prolonged
over-inflation (cuff pressure exceed 300 mmHg or maintained
above15 mmHg for longer than 3 minutes) of the bladder may
cause ecchymoma of your arm.
7. Consult your physician if you have any doubt about below cases:
1) The application of the cuff over a wound or inflammation
diseases;
2) The application of the cuff on any limb where intravascular
access or therapy, or an arterio-venous (A-V) shunt, is present;
3) The application of the cuff on the arm on the side of a
mastectomy;
4) Simultaneously used with other monitoring medical
equipments on the same limb;
5) The usage by a person with a cardiac pacemaker. The device
does not affect the cardiac pacemaker. However, if there is a
serious arrhythmia or a low pulse, the measurement results
may be inaccurate.
8. This digital automatic blood pressure monitor is designed for
adults and should never be used on infants or young children.
Consult your physician or other health care professionals before
use on older children.
9. Do not use this unit in a moving vehicle.
10. Blood pressure measurements determined by this monitor
are equivalent to those obtained by a trained observer using
the cuff/stethoscope auscultation method, within the limits
prescribed by the American National Standard Institute,
Electronic or automated sphygmomanometers.
11. Information regarding potential electromagnetic or other
interference between the blood pressure monitor and
other devices together with advice regarding avoidance
of such interference please see part ELECTROMAGNETIC
COMPATIBILITY INFORMATION.
12. Please do not use the cuff other than supplied by the
manufacturer, otherwise it may cause biocompatible hazard and
might result in measurement error.
13. The monitor might not meet its performance specifications or
cause safety hazard if stored or used outside the specified
temperature and humidity ranges in specifications.
14. Please do not share the cuff with other infective person to
avoid cross-infection.
15. Please note that changes or modifications not expressly
approved by the party responsible for compliance could void the
user’s authority to operate the equipment.
16. 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.
6. SETUP AND OPERATING PROCEDURES
6.1. Battery loading
a. Open battery cover at the back of the monitor.
b. Load two “AAA” size batteries. Please pay attention to polarity.
c. Close the battery cover.
d. Once you install the batteries or turn off the monitor, the LCD
does not display anything. Now the monitor is in Off.
If the LCD displays low battery symbol , the batteries are
running out and should be replaced with new ones.
Rechargeable batteries are not suitable for this monitor.
Remove the batteries if the monitor will not be used for a
month or more to avoid relevant damage of battery leakage.
Avoid the battery fluid to get in your eyes. If it should get in
your eyes, immediately rinse with plenty of clean water and
contact a physician.
The monitor, the batteries and the cuff, must be disposed
of according to local regulations at the end of their usage.
6.2. Applying the cuff
a. Place the cuff around a bare wrist 1-2cm
above the wrist joint on the palm side of
the wrist.
b. Place the arm with the cuffed wrist in
front of your body on a desk or table with
the palm up. If the cuff is correctly placed,
you can read the LCD display.
c. The cuff must be neither too tight nor too
loose. At the same time, there must be
no free space between the cuff and the
wrist.
6.3. Carrying out a measurement
Before the measurement:
Avoid eating, smoking as well as all forms of exertion directly
before the measurement. All these factors influence the
measurement result. Try and find time to relax by sitting in an
armchair in a quiet atmosphere for about five to ten minutes
before the measurement.
Measure always on the same arm.
Attempt to carry out the measurements regularly at the same
time of day, since the blood pressure changes during the
course of the day.
Body posture during measurement
Be seated with your feet flat on the floor, and
don’t cross your legs.
The first way to measure
a. Place palm upside in front of you on a flat
surface such as a desk or table.
b. Place something under your arm (for example,
the monitor storage bag) so that the middle of
the cuff was at the level of the heart. Make sure that the cuff is
not pressed by anything.
The second way to measure
a. Use the free hand to take the elbow of the arm with the blood
pressure monitor.
b. Place the arm with the monitor so that the palm of the arm
would be next to the opposite shoulder, and the monitor - at the
level of the heart.
c. Make sure that you see the display of the monitor. Relax your
wrist joint and wrist (do not move your wrist forward or back,
do not clench into a fist).
Common sources of error:
Movement during measurement
The monitor is not at the level of the heart
The cuff does not fit you in size
Loose cuff
6.4. Taking your blood pressure reading
a. After applying the cuff and your body is in a comfortable
position, press the “START” button. All display characters are
shown for self-test (Picture 1). Please contact the service center
if any segment is missing on the display.
b. The LCD will momentarily display the result of last measurement.
See picture 1-1. After the new power the LCD will momentarily
display 0.See picture 1-2.
Picture 1 Picture 1-1 Picture 1-2 Picture 1-3
c. Then the monitor inflates the cuff until sufficient pressure has
built up for a measurement. Then the monitor slowly releases
air from the cuff and carries out the measurement. Finally the
blood pressure and pulse rate will be calculated and displayed
on the LCD screen. Irregular heartbeat symbol (if any) will blink
on the screen. See picture 1-3.
d. After measurement, the monitor will turn off automatically
after 1 minute of no operation. Alternatively, you can press the
“START” button to turn off the monitor manually.
e. During measurement, you can press the “START” button to turn
off the monitor manually.
NOTE:
The monitor can memorize the last result. If you change
the batteries, the last result will not be saved.
NOTE:
Please consult a health care professional for
interpretation of pressure measurements.
6.5. Pulse Arrhythmia Detection
Appearance of the Pulse Arrhythmia Detection
Symbol means that a certain pulse irregularity was detected
during the measurement. In this case, the result can vary from your
actual blood pressure that’s why you should rest for 15 minutes and
repeat the measurement.
The appearance of symbol is accompanied by a sound signal.
As a rule this is not a cause for concern; however, if the symbol
appears more frequently, we recommend you inform your doctor.
The monitor does not replace the cardiological examination, but it
allows you to detect the arrhythmia even in early stages.
6.6. Technical alarm description
The monitor will show ‘HI’ or ‘Lo’ as technical alarm on LCD with
no delay if the determined blood pressure (systolic or diastolic) is
outside the rated range specified in part SPECIFICACIONS. In this
case, you should consult a physician or check if your operation
violated the instructions.
The technical alarm condition (outside the rated range) is preset
in the factory and cannot be adjusted or inactivated. This alarm
condition is assigned as low priority according to IEC 60601-1-8.
The technical alarm is non-latching and need no reset. The signal
displayed on LCD will disappear automatically after about 8
seconds.
6.7. Troubleshooting (1)
PROBLEM
POSSIBLE CAUSE
SOLUTION
LCD Display
shows
abnormal
result
The cuff position was
not correct or it was not
properly tightened
Apply the cuff correctly
and try again
Body posture was not
correct during testing
Review the “BODY
POSTURE DURING
MEASUREMENT”
sections of the
instructions and re-test
Speaking, arm or body
movement, angry,
excited or nervous
during testing
Re-test when calm and
without speaking or
moving during the test
Irregular heartbeat
(arrhythmia)
It is inappropriate
for people with
serious arrhythmia
to use this Electronic
Sphygmomanometer
1-2 cm
IEC 80601-2-30 : 2009+Cor.2010 (Medical electrical equipment –
Part 2-30: Particular requirements for the basic safety and
essential performance of automated non-invasive
sphygmomanometers),
EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive
sphygmomanometers – Part 1: General requirements),
EN 1060-3: 1997 + A1: 2005 + A2: 2009 (Non-invasive
sphygmomanometers – Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring systems).
10. SYMBOL INFORMATION
THE OPERATION GUIDE MUST BE READ
(The sign background colour: blue.The sign
graphical symbol: white)
WARNING
TYPE BF APPLIED PARTS
(The cuff is type BF applied part)
ENVIRONMENT PROTECTION –
Waste electrical products should not
be disposed of with household waste.
Please recycle where facilities exist. Check
with your local Authority or retailer for
recycling advice.
MANUFACTURER’S NAME
ARTICLE NUMBER
SERIAL NUMBER
OPERATING CONDITION,
TEMPERATURE 10˚C ~ 40˚C
STORAGE CONDITION,
TEMPERATURE –20˚C ~ 50˚C
KEEP DRY
HOUSING INGRESS PROTECTION RATE:
IP 22 (Protected from the penetration of
solid bodies with dimension greater than
12.5 mm. Protected from the penetration
of vertically falling water drops)
40
10
-20
50
11. WARRANTY INFORMATION
Warranty period is 3 years from the date of purchase for monitor
and 1 year for cuff. This warranty doesn’t cover any damages
caused by improper using, and also battery, and packaging. When a
manufacturing defect is revealed during the warranty period a faulty
unit would be repaired or, if repairing is impossible, replaced with
another one.
Manufacturing date is in a serial number: WWYYXXXXX.
The manufacturer may change units partially or completely if
necessary, without prior notice.
12. ELECTROMAGNETIC COMPATIBILITY
INFORMATION
For all ME EQUIPMENT and ME SYSTEMS
Table 1 – Emission
Phenomenon
Compliance
Electromagnetic
environment
RF emissions
CISPR 11
Group 1, Class B
Home healthcare
environment
Harmonic distortion
IEC 61000-3-2
Class A
Home healthcare
environment
Voltage fluctuations
and flicker
IEC 61000-3-3
Compliance
Home healthcare
environment
Table 2 – Enclosure Port
Phenomenon
Basic EMC
standard
Immunity test levels
Home Healthcare
Environment
Electrostatic
Discharge
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15
kV air
Radiated RF EM
field
IEC 61000-4-3
10 V/m
80 MHz – 2.7 GHz
80% AM at 1k Hz
Proximity fields
from RF wireless
communications
equipment
IEC 61000-4-3
Refer to table 3
Rated power
frequency magnetic
fields
IEC 61000-4-8
30 A/m
50 Hz
Table 3 – Proximity fields from RF wireless communications equipment
Test
frequency
(MHz)
Band (MHz)
Immunity test levels
Professional healthcare facility
environment
385
380-390
Pulse modulation 18 Hz, 27 V/m
450
430-470
FM, ±5 kHz deviation, 1 kHz sine, 28
V/m
710
704-787
Pulse modulation 217 Hz, 9 V/m
745
780
810
800-960
Pulse modulation 18 Hz, 28 V/m
870
930
1720
1700-1990
Pulse modulation 217 Hz, 28 V/m
1845
1970
2450
2400-2570 Pulse modulation 217 Hz, 28 V/m
5240
5100-5800 Pulse modulation 217 Hz, 28 V/m
5500
5785
6.8. Troubleshooting (2)
PROBLEM
POSSIBLE CAUSE
SOLUTION
LCD shows low
battery symbol
Low Battery
Change the
batteries
LCD shows “Er 0”
Pressure system
is unstable before
measurement
Don’t move and try
again
LCD shows “Er 1”
Fail to detect systolic
pressure
LCD shows “Er 2”
Fail to detect diastolic
pressure
LCD shows “Er 3”
Pneumatic system
blocked or cuff is too
tight during inflation
Apply the cuff
correctly and try
again
LCD shows “Er 4”
Pneumatic system
leakage or cuff is too
loose during inflation
LCD shows “Er 5”
Cuff pressure above 300
mmHg
Measure again
after five minutes.
If the monitor is still
abnormal, please
contact the local
distributor or the
factory
LCD shows “Er 6”
More than 3 minutes
with cuff pressure
above 15 mmHg
LCD shows “Er 7”
EEPROM accessing
error
LCD shows “Er 8”
Device parameter
checking error
LCD shows “Er A”
Pressure sensor
parameter error
No response when
you press button or
load battery
Incorrect operation or
strong electromagnetic
interference
Take out batteries
for five minutes,
and then reinstall all
batteries
7. MAINTENANCE
1. Do not drop this monitor or subject it to strong impact.
2. Avoid high temperature and solarization. Do not immerse the
monitor in water as this will result in damage to the monitor.
3. If this monitor is stored near freezing, allow it to acclimate to
room temperature before use.
4. Do not attempt to disassemble this monitor and do not
disconnect the cuff from the monitor.
5. If you do not use the moitor for a long time, please remove the
batteries.
6. It is recommended the performance should be checked every 2
years or after it has been dropped. Please contact the service
center.
7. Clean the monitor with a dry, soft cloth or a soft cloth squeezed
well after moistened with water or diluted detergent.
8. Keep the cuff clean. It is recommended the cuff should be
disinfected 2 times every week if needed (For example, in
hospital or in clinic). Wipe the inner side (the side contacts skin)
of the cuff by a soft cloth squeezed after moistened with a 3 %
solution of hydrogen peroxide, then dry the cuff by airing.
9. No component can be maintained by user in the monitor.
10. The external surfaces of the blood pressure monitors and the
cuff are resistant to disinfection with a 3% solution of hydrogen
peroxide.
8. SPECIFICATIONS
1. Product name: Wrist Blood Pressure Monitor, model: PRO-39
2. Classification: Internally powered, Type BF applied part, IP22,
No AP or APG, Continuous operation
3. Machine size: Approx. 73 mm×62 mm×28,5 mm
(2 7/8”x 2 1/2”x 1 1/8”)
4. Wrist cuff circumference: 14cm-19.5cm(approx.5 1/2”-7 11/16”)
5. Weight: not more than 69,3 g ± 10% (exclude batteries)
6. Measuring method: Oscillometric method, automatic inflation
and measurement
7. Memory Capacity: The last measurement is saved.
8. Power source: batteries: 2 ×1.5V SIZE AAA
9. Measurement range: Cuff pressure: 0-300 mmHg,
systolic: 60-280 mmHg, diastolic: 20-199 mmHg,
pulse rate: 40-200 beats/minute.
10. Accuracy: pressure: ±3mmHg, pulse rate: ±5%.
11. Environmental temperature for operation: 10°C~40°C
(50°F~104°F).
12. Environmental humidity for operation: ≤85% RH.
13. Environmental temperature for storage and transport:
-20°C~70°C (-4°F~122°F).
14. Environmental humidity for storage and transport: ≤85% RH.
15. Environmental pressure: 80kPa-105kPa.
16. Battery life: Approx 270 times.
17. Blood pressure monitor set: blood pressure monitor – 1 piece,
wrist cuff – 1 piece, bladder – 1 piece, AAA batteries – 2 pieces,
the instruction manual – 1 piece, box – 1 piece, a storage bag –
1 piece.
NOTE:
These specifications are subject to change without
notice.
9. APPLIED STANDARDS
The digital automatic blood pressure monitor corresponds to the
below standards:
IEC 60601-1:2005/EN 60601-1:2006/AC:2010 (Medical electrical
equipment – Part 1: General requirements for basic safety and
essential performance),
IEC60601-1-2:2007/EN 60601-1-2:2007 /AC:2010 (Medical
electrical equipment – Part 1-2: General requirements for
basic safety and essential performance – Collateral standard:
Electromagnetic compatibility – Requirements and tests),
IM_PRO39_EN_PL_425x320_3917
Caring for everyone
Caring for everyone
B.Well Swiss AG,
Bahnhofstrasse 24,
9443 Widnau, Switzerland
www.bwell-swiss.ch
