Microlife 3BT0-AP, 38t0-ap Instruction manual

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microlife Digital Fully Automatic Blood
Pressure Monitor with Patented
Irregular Heartbeat Detector
Model # 3BT0-AP Instruction Manual
CAUTION: If the Heartbeat Interval Irregularity Indicator icon comes on frequently, see your doctor. You
may require medical attention. Only a physician can diagnose irregular heartbeat.
US Patent # 6,485,429
(Irregular Heartbeat Detector)
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Automatic Blood Pressure Monitor
Instruction Manual
Table of contents
1. Introduction
1.1. Features of your blood pressure monitor
1.2. Important information about self measurement
2. Important information on blood pressure and its measurement
2.1. How does high/low blood pressure arise?
2.2. Which values are normal?
2.3. What can be done if regular high/low values are obtained?
2.4. Irregular Heartbeat Detector
3. Components of your blood pressure monitor
4. Operation of your blood pressure monitor
4.1. Inserting the batteries
4.2. Using an A/C power adapter
4.3. Tube connection
Measurement Procedure
5.1. Before measurement
5.2. Common sources of error
5.3. Fitting the cuff
5.4. Setting the time and date
5.5. Measuring procedure
5.6. Memory – displaying the last measurement
5.7. Discontinuing a measurement
6. Error Messages/Troubleshooting
7. Care and maintenance
8. Warranty
9. Certifications
10. Technical specifications
11. How to Contact Us
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1. Introduction
1.1.Features of your Microlife automatic blood pressure monitor,
model # 3BT0-AP
Your Microlife blood pressure monitor is a fully automatic digital blood pressure
measuring device with an integrated Irregular Heartbeat Detector, for use by adults on the
upper arm at home or in your doctor’s/nurse’s office. It enables very fast and reliable
measurement of the systolic and diastolic blood pressure as well as the pulse by way of
the oscillometric method. This device offers clinically proven accuracy and has been
designed to be user friendly.
Before using, please read this instruction manual carefully and then keep it in a safe
place. Please contact your doctor for further questions on the subject of blood pressure
and its measurement.
Attention!
1.2.Important information about self-measurement
• Self-measurement means Control, not diagnosis or treatment. Unusual values
must always be discussed with your doctor. Under no circumstances should you
alter the dosages of any drugs prescribed by your doctor.
• The pulse display is not suitable for checking the frequency of heart pacemakers!
• In cases of irregular heartbeat (Arrhythmia), measurements made with this instrument
should only be evaluated after consultation with your doctor.
Electromagnetic interference:
The device contains sensitive electronic components. Avoid strong electrical or
electromagnetic fields in the direct vicinity of the device (e.g. mobile telephones,
microwave ovens). These can lead to temporary impairment of the measuring accuracy.
2. Important information on blood pressure and its measurement
2.1. How does high/low blood pressure arise?
Your level of blood pressure is determined in the circulatory center of the brain and
adjusts to a variety of situations through feedback from the nervous system. To adjust
blood pressure, the strength and frequency of the heart (Pulse), as well as the width of
circulatory blood vessels is altered. Blood vessel width is effected by fine muscles in the
blood vessel walls.
Your level of arterial blood pressure changes periodically during heart activity: During the
“blood ejection” (Systole) the value is highest (systolic blood pressure value). At the end
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of the heart’s “rest period” (Diastole) pressure is lowest (diastolic blood pressure value).
Blood pressure values must lie within certain normal ranges in order to prevent particular
diseases.
2.2. Which values are normal?
Blood pressure is too high if your diastolic pressure is above 90 mmHg and/or your systolic blood pressure
is over 160 mmHg, while at rest. In this case, please consult your physician immediately. Long-term values at this level endanger your health due to continual damage to the blood vessels in you body.
If your systolic blood pressure values are between 140 mmHg and 160mmHg and/or the diastolic
blood pressure values between 90 mmHg and 95mmHg, consult your physician. Regular self-checks
are necessary.
If you have blood pressure values that are too low, (i.e., systolic values under 105mmHg and/or diastolic
values under 60 mmHg), consult your physician.
Even with normal blood pressure values, a regular self-check with your blood pressure monitor is
recommended. You can detect possible changes in your values early and react appropriately.
If you are undergoing medical treatment to control your blood pressure, keep a record of values along with
time of day and date. Show these values to your physician. Never use the results of your measurements to independently alter the drug doses prescribed by your physician.
Which values are normal?
The following standards for assessing high blood pressure (without regard to age) have been established
by the National Institutes of Health JNCVI.
Category
Optimal
Normal
High Normal
Hypertension
Stage 1
Stage 2
Stage 3
3
Systolic
Diastolic
(mmHg)
(mmHg)
<120
<130
130-139
<80
<85
85-89
140-159
160-179
≥180
90-99
100-109
≥110
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☞ Further information
• If your values are mostly normal under resting conditions but exceptionally high under
conditions of physical or psychological stress, it is possible that you are suffering from
so-called “labile hypertension.” Consult your doctor.
• Correctly measured diastolic blood pressure values above 120mmHg and
require immediate medical treatment.
2.3. What can be done if regular high or low values are obtained?
a) Consult your doctor.
b) Increased blood pressure values (various forms of hypertension) are associated with
considerable health risks over time. Arterial blood vessels in your body are endangered
due to constriction caused by deposits in the vessel walls (Arteriosclerosis). A deficient
supply of blood to important organs (heart, brain, muscles) can result from
arteriosclerosis. Furthermore, the heart will become structurally damaged with
increased blood pressure values.
c) There are many different causes of high blood pressure. We differentiate between the
common primary (essential) hypertension, and secondary hypertension. The latter
group can be ascribed to specific organ malfunctions. Please consult your doctor for
information about the possible origins of your own increased blood pressure values.
d) There are measures which you can take to reduce and even prevent high blood
pressure. These measures must be permanent lifestyle changes.
A) Eating habits
• Strive for a normal weight corresponding to your age. See your doctor for your ideal
weight.
• Avoid excessive consumption of common salt.
• Avoid fatty foods.
B) Previous illnesses
• Consistently follow all medical instructions for treating illness such as:
• Diabetes (Diabetes mellitus or sugar diabetes)
• Fat metabolism disorder
• Gout
C) Habits
• Give up smoking completely.
• Drink only moderate amounts of alcohol.
• Restrict your caffeine consumption (coffee, tea, chocolate).
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D) Your Physical condition
• After a medical examination, and with your doctor’s approval and direction;
exercise.
• Choose sports which require stamina and avoid those which require strength.
• Avoid reaching the limit of your performance.
• With previous illnesses and/or an age of over 40 years, please consult your doctor
before beginning your exercise routine. You must receive advise regarding the type and
extent of exercise that is appropriate for you.
2.4. Irregular Heartbeat Detector
The appearance of this symbol
signifies that a certain irregular heartbeat
was detected which could cause cardiovascular disease. This indicator is only a
caution. The Microlife Fully Automatic Blood Pressure Monitor with Heartbeat
Irregular Heartbeat Detector can detect blood pressure and pulse rate
measurement with specifications even when the patient is having an irregular
heartbeat interval. It is important that you be relaxed, remain still and do not talk
during the measurements.
Note: We recommend contacting your physician if you see this “ “ icon frequently.
CAUTION: An irregular heartbeat can be a serious medical condition requiring
medical attention. See your doctor if you suspect you have an irregular heartbeat.
3. Components of your blood pressure monitor
a) Measuring unit
AC/DC Power Port
Cuff Connection Port
Time Button
START/STOP Button
5
Memory Button
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b) Upper arm cuffs:
Type S101 for arm circumference 22-33.7 cm or
9.5” - 13.25” (included)
Type S102 for arm circumference 30.5-40.64 cm
12” - 16” (order as a special accessory)
Please Note:
Arm circumference should be measured with a measuring tape in the middle of the relaxed
upper arm. Do not force cuff connection into the opening. Make sure the cuff connection is
not pushed into the AC adapter port. If the cuff is too small, call
for further
information.
4. Operation of your blood pressure monitor
4.1. Inserting the batteries
After you have unpacked your device insert the batteries. The battery compartment is
located on the back side of the device (see illustration).
a) Remove cover as illustrated.
b) Insert the batteries (4 AA, 1.5 V), following the
indicated polarity. (+ -)
+
+
+
+
c) If the low battery indicator appears in the
display, the batteries are discharged and the
unit will not function.
d) If batteries are inserted incorrectly, the display
may function erratically or not at all.
Check battery polarity.
Low Battery Indicator
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Attention!
• After the low battery indicator appears, the device won’t function until the batteries
have been replaced.
• Please use “AA” Long-Life or Alkaline 1.5V Batteries.
• Do not use rechargeable batteries.
• If the blood pressure monitor is not used for long periods, remove the batteries from
the device.
Functional check: Hold the On/Off button down to test all the display elements. When
functioning correctly many icons will appear.
4.2. Using an AC power adapter (special accessory)
It is possible to operate this blood pressure instrument with an AC adapter. (output 6 V DC
/ 600 mA with DIN plug). Make certain that you use an adapter which fulfills the legal
requirements and electronic requirements in the U.S. (UL standard). Use of an AC adapter
other than a Microlife adapter may invalidate your warranty.
a) Push the plug into the socket at the left side
of the instrument.
Left Opening
b) Plug the AC adapter into a 110 V
power socket (U.S. or Canada).
c) Test that power is available by
pressing the On/Off button.
Note:
• No power is taken from the batteries while the AC adapter is connected to the
instrument.
• If the power is interrupted during a measurement (e.g. by removal of the adapter from
the wall socket), the instrument must be reset by removing the plug from the
instrument.
• Please call 1-800-568-4147 if you have questions
relating to the AC adapter.
4.3. Tube connection
Insert the cuff tube into the opening
provided on the side of the instrument,
as shown in the diagram.
Right Opening
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5. Measurement Procedure
Please note: You should always be seated before and during measurement.
5.1. Before measurement:
• Avoid eating and smoking as well as all forms of exertion directly before
measurement. These factors influence the measurement result. Find time to relax by
sitting in an armchair in a quiet atmosphere for about ten minutes before
measurement.
• Remove any garment that fits closely to your upper arm.
• Always measure on the same arm (normally left).
• Always perform measurements at the same time of day, since blood pressure changes
during the course of the day.
5.2. Common sources of error:
Note: Comparable blood pressure measurements always require the same conditions! Conditions should always be quiet.
• All efforts by the user to support the arm can increase blood pressure. Make sure you
are in a comfortable, relaxed position and do not flex any of the muscles in the measurement arm during the measurement. Use a cushion for support if necessary.
• If the arm artery lies considerably lower or higher than the heart, an erroneously high or
low blood pressure will be measured! Each 15cm (6 inch) difference in height between
your heart and the cuff results in a measurement error of 10 mmHg!
• Cuffs that are too narrow or too short result in false measurement values. Selecting the
correct cuff is extremely important. Cuff size is dependent upon the circumference of the
arm (measured in the center). The permissible range is printed on the cuff. If this is not
suitable for your use, please contact microlife USA. Large cuff sizes are sold separately.
Note: Only use clinically approved microlife Cuffs!
• A loose cuff or a sideways protruding air pocket causes false measurement values.
• With repeated measurements, blood accumulates in the arm, which can lead to false
results. Consecutive blood pressure measurements should be repeated after a 1 minute
pause or after your arm has been held up in order to allow the accumulated blood to
flow away.
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5.3. Fitting the cuff
a) Pass the end of the cuff through the flat
metal ring so that a loop is formed. The
velcro closer must be facing outward. (Ignore
this step if the cuff has already been
prepared.)
b) Place the cuff over the left upper arm so that
the tube is closer to your lower arm.
c) Lay the cuff on the arm as illustrated. Make
certain that the lower edge of the cuff lies
approximately 3/4” to 1”(2 to 3cm) above the
elbow and that the tube is closer to the inner
side of the arm.
Important! The small white arrow on the
cuff must lie exactly over the artery which
runs down the inner side of the arm.
d) Tighten the cuff by pulling the end and close
the cuff by affixing the velcro.
e) There should be little free space between the
arm and the cuff. You should able to fit 2
fingers between your arm and the cuff.
Clothing must not restrict the arm. Any piece
of clothing which does must be removed.
Cuffs that don’t fit properly result in false
measurement values. Measure your arm
circumference if you are not sure of proper
fit. Larger cuffs are available (Section 3B).
f) Lay your arm on a table (palm upward) so the
cuff is at the same height as your heart.
Make sure the tube is not kinked.
g) Remain seated quietly for two minutes
before you begin the measurement.
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Left Arm
3/4”-1”
tube
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Comment:
If it is not possible to fit the cuff to your left arm, it can also be
placed on your right arm. However, all measurements should be
made using the same arm.
Comparable blood pressure measurements always require the
Cuff on
same conditions (Relax for several minutes before a reading).
right arm
5.4. Setting the time and date
This blood pressure monitor incorporates an integrated clock with date display. Time and
date are recorded along with pressure and pulse. After new batteries have been inserted,
the clock begins to run from the following setting: 2000-01-01 00:00 O’clock.
You must then re-enter the date and current time. Please proceed as follows (Example:
Entering 2002-06-15 Time 09:30 AM):
1.
Press the Time button for at least 3 seconds. The display
now indicates the set year, during which the four characters
blink.
2.
The correct year can be entered by pressing the MEMORY
button. Once for each change.
(Example: 1 x press).
3.
Press the Time button again. The display now switches to
the current date, during which the first character (month)
blinks.
Note: Holding the button down speeds up the procedure.
4.
The current month can now be entered by pressing the
MEMORY button.
Example: pressing 6 x advances 6 months)
5.
Press the Time button again. The last two characters (day)
are now blinking.
6.
The current day can now be entered by pressing the MEMORY button. (Example: 15 x presses advances the day from
the 1st to 15th)
7.
Press the Time button again. The display now switches to
the current time, during which the first character (hour)
blinks.
M
M
M
TIME
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9. Press the User/Time button again. The last two characters (Minutes) now blink.
10. The minutes can now be entered by pressing the MEMORY button. (Example: 30 x
presses advances the time from 0 to 30 minutes)
5.5. Reading the set date
After all settings have been made, click the User/Time button once. The date is briefly displayed and then the time. The input is now confirmed and the clock begins to run.
5.6. Measuring procedure
After the cuff has been appropriately positioned the
measurement can begin:
Pumping
Pressure
a) Press the ON/OFF/START button. The pump begins to
inflate the cuff. In the display, the increasing cuff
pressure is continually displayed.
b) After automatically reaching an individual pressure,
the pump stops and the pressure slowly falls. The cuff
pressure is displayed during the measurement.
c) When the device has detected your pulse, the heart
symbol in the display begins to blink and a beep tone
is audible for every pulse beat.
Measuring
d) When the measurement has been concluded, a long
beep tone sounds. The measured systolic and diastolic
blood pressure values, as well as the pulse are now
displayed.
e) The appearance of this symbol
signifies that a
certain irregular heartbeat was detected. This
indicator is only a caution. It is important that you be
relaxed, remain still and do not talk during
measurements. NOTE: We recommend contacting
your physician if you see this
icon frequently.
f) The measurement results are displayed until you
switch the device off. If no button is pressed for 5
minutes, the device switches off automatically.
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Systolic
Diastolic
Pulse
Measurement
complete
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5.7. Memory – displaying the last 99 measurements
The measured results are stored in the instrument until a new
measurement is carried out. With the unit in the OFF position,
press and hold the MEMORY button for at least 3-seconds. The
screen will show the last reading along with time and date.
The MR symbol is displayed in the lower left. Release the button.The last
reading will be displayed. Each time you press the memory button an
earlier measurement will be displayed along with time and date.
Last
If an irregular heartbeat was detected in any measurements
reading
stored in memory, the
icon will be displayed.
14 readings
5.8. Discontinuing a measurement
in memory
If it is necessary to interrupt a blood pressure measurement for any reason
(e.g the patient feels unwell), the ON/OFF button can be pressed at any
time. The device then immediately lowers the cuff pressure automatically.
14
MR
MR
6. Error Messages/Troubleshooting
If an error occurs during a measurement, the measurement is
discontinued and a corresponding error code is displayed. We
recommend you switch the device off and take a new measurement
making sure you allow time for relaxation.
(example: error no. 1)
Error No.
ERR 1
ERR 2
Possible cause(s) / Solutions
The tube may have loosened, or no pulse
was detected.
*Ensure cuff connections are tight with
proper cuff placement. See section (5.3)
Unnatural pressure impulses. Reason:
The arm was moved during the
measurement (Artefact).
Repeat measurement keeping arm still.
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ERR 3
Repeat measurement keeping arm still.
If inflation of the cuff takes too long, the
cuff is not correctly seated or the hose
connection’s not tight.
Check connections and repeat.
ERR 5
The difference between systolic and
diastolic is excessive. Measure again
carefully following proper cuff procedures
and ensure measurement under quiet
conditions.
Other possible errors and their solutions
If problems occur when using the device, the following points should be checked:
Malfunction
Remedy
The display remains blank when the instrument • Check battery installation.
is switched on although the batteries are in
• If the display is unusual, remove the batteries
place.
and then exchange them for new ones.
Check polarity.
The pressure does not rise although the pump • Check the connection of the cuff tube and
is running.
connect properly.
The device frequently fails to measure,
1. Fit the cuff correctly on the arm. (see 5.3)
or the values measured are too low or high.
2. Before starting measurement make sure
that the cuff is not too tight and that clothing
is not exerting pressure on the arm. Take
articles of clothing off if necessary.
3. Measure blood pressure again in complete
peace and quiet.
Every measurement results in different values, • Please read the following information and
although the device functions normally and
the points listed under “Common sources of
normal values are displayed.
error”.(5.2) Repeat the measurement.
• Blood pressure changes constantly. The
observed readings may accurately reflect
your pressure.
Blood pressure values differ from those
• Record daily values and consult your doctor.
measured by my doctor
• Pressure readings in your doctor’s office may
be higher due to anxiety.
After the instrument has inflated the cuff the
•Check cuff connections.
pressure falls very slowly, or not at all. (No
Ensure the unit has not been tampered with.
reasonable measurement possible).
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7. Care and maintenance
a) Do not expose the device to either extreme
temperatures, humidity, dust or direct
sunlight.
b) The cuff contains a sensitive air-tight bubble.
Handle this cuff carefully and avoid all types
of stress through twisting or buckling.
c) Clean the device with a soft, dry cloth. Do not
use gas, thinners or similar solvents. Spots
on the cuff can be removed carefully with a
damp cloth and soapsuds. The cuff must
not be washed in a dishwasher,
clothes washer, or submerged in water.
d) Handle the tube carefully. Do not pull on it.
Do not allow the tubing to kink and keep it
away from sharp edges.
e) Do not drop the monitor or treat it roughly in
any way. Avoid strong vibrations.
f) Never open the monitor! This invalidates
the manufacturer’s warrantee.
9. Warranty
Your microlife blood pressure monitor is guaranteed for 5 years against
manufacturers’ defects for the original purchaser only, from date of purchase. The
warranty does not apply to damage caused by improper handling, accidents,
professional use, not following the operating instructions or alterations made to the
instrument by third parties.
There are no user serviceable parts inside. Batteries or damage from old batteries is
not covered by the warranty. The warranty is only valid upon presentation of the
warranty card.
Please note: According to international standards, your monitor should be checked
for calibration every 2 years.
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If fluctuations in readings are larger than 15 mmHg, and/or you hear irregular
pulse tones, and/or the Heartbeat Interval Irregularity Indicator appears
frequently, consult your doctor.
In order to receive market clearance from governmental bodies, this device was subjected
to strict clinical tests. The computer program used to measure blood pressure values was
tested by experienced cardiac specialists in Germany.
The manufacture of your
blood pressure monitor is in accordance with the
terms of the European standard for blood pressure measuring devices (see technical data)
under the supervision of the Technical Monitoring Association Essen (RWTüV-Essen).
Never attempt to repair the instrument yourself!
Any unauthorized opening of the instrument invalidates all warrantee claims!
9. Certifications
Device standard:
This device is manufactured to meet the
European and United States standards for
non-invasive blood pressure monitors:
EN1060-1 / 1995
EN1060-3 / 1997
ANSI / AAMI SP10, NIBP – requirements
Electromagnetic compatibility:
Device fulfills the stipulations of the
International standard IEC60601-1-2
Clinical testing:
Clinical performance tests were
successfully completed against AAMI
SP10-1992 and British Hypertension
Society protocol B.H.S.: 1993.
Studies available on request.
The B.H.S. (British Hypertension Society) has rated this product “Recommended for clinical
and home use.” This is the highest grading available for blood pressure monitors. Please
see the B.H.S. web site. (Uses the same algorithm as B.H.S. graded “AA” model number
3BT0-1)
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10. Technical specifications:
Weight:
Size:
Storage temperature:
Humidity:
Operation temperature:
Display:
Measuring method:
Pressure sensor:
Measuring range:
SYS/DIA:
Pulse:
Cuff pressure display range:
Memory:
Measuring resolution:
Accuracy:
Power source:
Accessories:
Made in China.
Manufactured by Microlife Corporation
Distributed by:
USA, Inc.
424 Skinner Blvd. Suite C
Dunedin, FL 34698
Toll free: 800-568-4147
Email: [email protected]
www.microlifeusa.com
483 g (with batteries)
124 (W) x 205 (L) x 81 (H) mm
–5 to +50°C (23°F - 122°F)
15 to 85% relative humidity maximum
10 to 40°C ( 50°F - 104°F)
LCD-Display (Liquid Crystal Display)
oscillometric
capacitive
30 to 280 mmHg
40 to 200 per minute
0–299 mmHg
Automatically stores the last 99
measurements.
1 mmHg
pressure within ± 3 mmHg
pulse ± 5 % of the reading
a) 4 AA batteries, 1.5 V
b) AC adapter 6 V DC 600 mA
(voltage 4.5 V DC to 6 V DC)
cuff type S101 for arm circumference
24–33.7 cm (9.5” -13.25”) (included)
cuff type S102 for arm circumference
30.5-40.64 cm (12” - 16”)
(call Microlife for details)
Technical alterations reserved!
US patent # 6,485,429
(Irregular Heartbeat Detector)
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12. How to Contact Us
Toll Free Help Line: 1-800-568-4147
Fax (727) 451-0492
Microlife USA, Inc.
424 Skinner Blvd.
Suite C
Dunedin, FL 34698
[email protected]
www.microlifeusa.com
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Sistólica
(mmHg)
<120
Diastólica
(mmHg)
<80
Normal
<130
<85
Normal Alta
130-139
85-89
Estado 1
140-159
90-99
Estado 2
160-179
100-109
Estado 3
180
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con
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+
+
+
+
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Left Arm
3/4”-1”
tube
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Cuff on
right arm
M
M
TIME
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Ultima lectura
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MR
MR
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ERR 2
ERR 3
ERR 5
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Hecho en China
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Manufacturado por Microlife Corporation
Distribuido por:
Microlife USA, Inc.
424 Skinner Blvd. Suite C
Dunedin, FL 34698
Tel. : 800-451-0492
Email : [email protected]
www.microlifeusa.com
11. Como Contactarnos
Numero sin cargo : 1-800-568-4147
Fax (727)451-0492
Microlife USA, Inc.
424 Skinner Blvd.
Suite C
Dunedin, FL 34698
[email protected]
www.microlifeusa.com
Patente :
6,485,429 (Latido Irregular)