Cvs BP3BU1-4U User Manual

CVSBU1-4-JUL06-FDA-1

DIGITAL

ADVANCED

WRIST

Blood Pressure Monitor

With PC Link

Software

Model #BP3BU1-4U

ID #271248 (3BU1-4U)

Instruction Manual

Instrucciones de Uso

Questions? Preguntas?

1-866-464-6184

THIS MEDICAL INSTRUMENT MUST BE USED ACCORDING

TO INSTRUCTIONS TO ENSURE ACCURATE READINGS.

PLEASE NOTE:

Advanced Wrist Blood Pressure Monitor

Instruction Manual
Table of contents

1. Introduction

1.1. Features of the BP3BU1-4U Blood Pressure Monitor

1.2. Important information about self-measurement

2. Important information on the subject of 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. MAM Technology

3. The various components of the blood pressure monitor

4. Putting the blood pressure monitor into operation

4.1. Inserting the batteries

4.2. Sleep mode

4.3. Setting the time and date

4.4. User selection

5. Carrying out a measurement

5.1. Before the measurement

5.2. Common sources of error

5.3. Fitting the cuff

5.4. Measuring procedure

5.5. Discontinuing a measurement

5.6. Memory – storage and recall of the measurements

5.7. Memory – recall of 3 intermittent average results

5.8. Memory – cancellation of all measurements

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6. Error messages/malfunctions

7. Care and maintenance

8. Warranty

9. Reference to standards

10. Technical specifications

11. How to contact us

Blood Pressure Analyzer Software
(Sold Separately as an Optional Accessory):

This unit can be used in connection with your PC using the Micro­life Blood Pressure Analyzer software and a USB cable. Your PC
will allow a capacity of monitoring 80 patients, each with 1000 data
(note: overuse will lower system efficiency). For information about
the software and how to purchase, call 1-866-464-6184.

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1. Introduction

1.1. Features of the BP3BU1-4U Blood Pressure Monitor

The CVS/Microlife blood pressure monitor is a fully automatic, digital blood
pressure measuring device for use on the wrist. This monitor enables very
fast and reliable measurement of your systolic and diastolic blood pressure
as well as pulse by way of the oscillometric method of measuring. This
device offers a very high and clinically tested measurement accuracy and is
designed for maximum user-friendliness. Before using it, please read
through this instruction manual carefully and keep it in a safe place. For fur­ther questions on the subject of blood pressure and its measurement,
please contact your doctor.

Attention!

1.2. Important information about self-measurement

Self-measurement means control, not diagnosis or treatment. Your
values must always be discussed with your physician. You should never

alter the dosages of any medication without direction from your
physician. The pulse display is not suitable for checking the functioning of

heart pacemakers!!

In cases of irregular heartbeat, measurements made with this
instrument should only be evaluated after consultation with your
doctor.
Electromagnetic Interference: This device contains sensitive electronic

components. Avoid strong electrical or electromagnetic fields in the direct
vicinity of the device (e.g. mobile telephones, microwave ovens, etc.). These
can lead to temporary impairment of the monitor’s
measuring accuracy.

2. Important information about 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

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vessels is altered. Blood vessel width is affected by way of 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 of the heart’s "rest period" (Diastole)
pressure is lowest (diastolic blood pressure value). Your 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 through continual damage to the blood vessels in you
body. Should your systolic blood pressure values lie between 140 mmHg and
160mmHg and/or your diastolic blood pressure values lie between 90 mmHg
and 95mmHg. Consult your physician. Regular self-checks will be 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 reagard to
age) have been established by the U.S. National Institutes of Health JNC7, 2003.

Category Systolic Diastolic

Normal <120 <80

Self Check

Pre-Hypertension 120-139 80-89

Stage 1 140-159 90-99

Hypertension
Stage 2 >160 >100

Hypertension

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(mmHg) (mmHg)

☞ 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
your are suffering from so-called "labile hypertension." Consult your physi­cian.

• Correctly measured diastolic blood pressure values above 120mmHg
require immediate medical treatment.

2.3 What can be done if regular high/low values are obtained?

a) Consult your physician.

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 constrictions caused by deposits in the
vessel walls (Arteriosclerosis). A deficient supply of blood to important
organs (heart, brain, muscles) can result. 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. Secondary hypertension can be ascribed to specific organ
malfunctions. Please consult your physician for information about the pos­sible origins of your own increased blood pressure values.

d)There are measures you can take to reduce and even prevent high

blood pressure. These measures must be permanent lifestyle changes.

1) 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.

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2) Previous illnesses

• Consistently follow all medical instructions for treating illness such as:
diabetes (diabetes mellitus or sugar diabetes), fat metabolism disorder,
and gout.

3) Habits

• Give up smoking completely.

• Drink only moderate amounts of alcohol.

• Restrict your caffeine consumption (coffee, tea and chocolate).

4) 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 physician before beginning your exercise routine. You
must receive advice regarding the type and extent of exercise that is

appropriate for you.

2.4 MAM Technology

Microlife Average Mode (MAM) Technology is a new concept for optimum
reliability in self’measurement of blood pressure. A single measurement is
rarely your real result. An average of three readings is medically proven to
provide the most accurate result. With the push of a single button, the Micro­life Average Mode blood pressure monitor takes three consecutive measure­ments, and calculates the average.

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3. Components of your blood pressure monitor

USB PORT

TIME button

ON/OFF

Wrist Cuff

LCD display

Battery Cover

Mode selection switch

(1 or 3 Measurements)

MEMORY button

The illustration shows your blood pressure monitor
(ID # 271248/3BU1-4U), consisting of:

Fits wrist size 13.5-19.5cm (5.3"-7.7")

4. Putting your blood pressure monitor into operation

4.1. Inserting the batteries

After you have unpacked your device, insert the batteries. The battery
compartment is located on the left lateral side of the device (see illus­tration).

a) Remove cover as illustrated.
b) Insert the batteries (2 x AAA 1.5V), observing the indicated polarity.
c) If the battery warning appears in the display, the batteries are

exhausted and must be replaced by new ones.

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Attention!

1

1

1

mmHg

mmHg

MR

1

2

• After the battery warning appears, the device is blocked
until the batteries have been replaced.

• Please use «AAA» Long-Life or Alkaline 1.5V Batteries. The
use of rechargeable batteries is not recommended.

• If the blood pressure monitor is left unused for long periods, please
remove the batteries from the device.

Functional check:

Press and hold the ON/OFF button to test all the display
elements. When functioning correctly all segments appear.

4.2. Sleep mode

The device is designed to stay at the sleep mode after batteries are
inserted. In this mode, the time and user icon will be displayed. You can
conduct the following operations in this mode.

• Reading the set date:

Press the TIME
button. The date set will be displayed for
2 seconds.

• Recalling your measur

ements: Press the
MEMORY button. The measuring data
stored can be displayed. For more infor­mation refer to the section on Memory
storage and recall.

• Changing the User:

(See 4.4 for more
details) This advanced monitor tracks
memory for two users separately. Press
and hold the time button ( ) until the

or icon flashes. Next release the
button. Press the memory button ( ).
The unit will now record readings for
User 1 or User 2 as indicated.

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Low battery

indicator

4.3. Setting the time and date

This blood pressure monitor incorporates an integrated clock with date
display. The advantage is the exact time each measurement is recorded.
After new batteries have been inserted, the clock begins to run from the
following setting: 2003-01-01 00:00 O’clock. You must then re-enter the
date and current time. For this, please proceed as follows (Example:
Entering 2004-06-20 Time 09:30 o’clock):

1) Press and hold the Time button for three
seconds. User 1 or 2 will begin flashing.
Press the Time button again briefly. Now
you can begin changing the time and
date.

2) The correct year can be entered by
pressing the MEMORY button.

(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.

4) The corresponding month can now be
entered by pressing the MEMORY button.
Example: 6 x presses)

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5) Press the TIME button again. The last

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two characters (day) are now blinking

6) The corresponding day can now be
entered by pressing the MEMORY button.

(Example: 20 x presses)

7) Press the TIME button again. The display
now switches to the current time, during
which the first character (Hour) blinks

8) The corresponding hour can now be
entered by pressing the MEMORY button.
(Example: 9 x presses)

9) Press the TIME button again. The last
two characters (Minutes) now blink

10) The exact time can now be entered by

pressing the MEMORY button. (Example:
30 x presses)

11) After all settings have been made, press

the TIME button once again. The date is
briefly displayed and then the time. The
input is now confirmed and the clock
begins to run.

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☞ Further Information

1

2

1

2

With each press of the button (TIME, MEMORY) one input is made
(e.g. switching over from hours to minutes mode, or altering the value
by +1). However, if you keep the respective button depressed, you can
switch more quickly to the desired mode, or find the desired value
respectively.

4.4. User selection:

This advanced blood pressure monitor allows you
to track blood pressure readings for 2 individuals
independently.

a) Before measurement make sure you set

the unit for the intended user. The unit
can track results for 2 individuals. (User 1,
User 2)

b) The unit is set to User 1. Push and hold

the TIME button for 4 seconds to initiate
the user selection.

c) When the user icon is flashing, press the

MEMORY button to toggle between
users.

d) When the correct user is selected wait

three seconds for the user icon to stop
flashing. The monitor is now ready for
use.

e) Repeat the procedure again to change

users again.

b)

c)

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5. Carrying out a measurement

5.1. Before the measurement:

• Avoid eating, smoking as well as all forms of exertion directly before
your measurement. These factors influence the measurement result.
Relax by sitting in an armchair in a quiet atmosphere for about ten
minutes before your measurement.

• Always measure on the same wrist (normally left).

• Compare readings at the same time of day, since your 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! These are normally always quiet conditions.

• All efforts by the patient to support the arm can increase blood pres­sure. Make sure you are in a comfortable, relaxed position and do not
activate any of the muscles in the measurement arm during the mea­surement. Use a cushion for support if necessary.

• If the wrist artery lies considerably lower (higher) than the heart, an
erroneously higher (lower) blood pressure will be measured! (Each
15cm/6" difference in height results in a measurement error
of10mmHg!)

• A loose cuff causes false measurement values.

• With repeated measurements, blood can accumulate in the respective
arm, which can lead to false results. Correctly executed blood pressure
measurements should therefore first be repeated after a 1 minute
pause or after the arm has been held up in order to allow the accumu­lated blood to flow away.
(Does not apply to a MAM measurement.)

5.3. Fitting the cuff

a) Remove all objects and jewelry (e.g.

wristwatch) from the wrist in use. Put the
cuff over the wrist with the monitor face

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on the inside of the wrist.

b) The distance between the cuff and the

hand should be approx. 10 mm (1/2").

c) Secure the cuff with the Velcro fastener,

so that it lies comfortably and not too
tight. No space should remain between
the cuff and the wrist.

) Lay your arm on a table, with the palm

d

upwards.

Support the arm a little with a cushion, so that the cuff rests at about the
same height as the heart. Remain still for 2 minutes, before beginning the
measurement.

5.4. Measuring procedure

After the cuff has been appropriately positioned, and you’ve selected User
1 or User 2, the measurement can begin:

a) If you want to take an Average Mode

measurement position the slide switch to
the 3. Remember, in this mode, the unit
takes 3 measurements (one after another)
and calculates the result. There is a 15
second rest time between measurements.
The unit beeps five seconds before each
upcoming measurement.

(Data obtained in Average Mode are indi-

cated by the MAM symbol.)

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b) If you want to take a Single measure-

1

1

mmHg

mmHg

1

mmHg

mmHg

ment, position the slide switch to the left.
In this mode there is only one measure­ment cycle.

c) Once you’ve selected the correct user,

and measurement mode you can press
the ON/OFF button to begin. After press­ing the ON/OFF button the pump begins
to inflate the cuff. In the display, the
increasing cuff-pressure is continually
displayed.

d) After reaching the inflation pressure, the

pump stops and the pressure slowly falls.
The cuff pressure (large characters) is dis­played during the measurement. When
the device has detected the pulse, the
heart symbol in the display begins to
blink and a beep tone is audible for every
pulse beat.

e) When the measurement has been con-

cluded, a long beep tone sounds. The
measured systolic and diastolic blood
pressure values as well as the frequency
are now displayed. (Pulse=number of
heartbeats each minute) Example (Fig.):
Systolic 118, Diastolic 73, Pulse 75. The
measurement results are displayed until
you switch the device off. If no button is
pressed for 5 minutes, the device switch­es off automatically to save the batteries.

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Pulse Detected -

Unit measuring