microlife BP3MY1-1P Instruction Manual
Important Product and Safety Information
Follow Instructions for Use. This document provides important
product operation and safety information regarding this Blood
Pressure Monitor. Please read this document thoroughly before
using the device and keep for future reference.
This blood pressure monitor is an automatic digital blood pressure measuring device for use by adults on the wrist at home or in the doctor’s
office. It enables a very fast and reliable measurement of the systolic and
diastolic blood pressure, as well as the pulse rate, by way of the oscillometric method. This device detects the appearance of irregular heartbeats
during measurement and provides a warning signal when the irregular
heartbeat is detected.
This blood pressure monitor IS intended to be used:
• For self-measurement/monitoring of blood pressure and pulse in
adults; whereas the person being measured may be the user/operator
of the device.
• Within a home healthcare environment.
• With a cuff located upon the user’s wrist; ½ inch from the hand.
This blood pressure monitor IS NOT intended for use with:
• Pregnancy
•Preeclampsia
• Children under 12
• Neonatal patients
WARNING – Potentially hazardous situation that if not
avoided may result in serious injury or death.
• Self-measuring means monitoring, not diagnosis or treatment. Unusual
values must always be discussed with your doctor. Under no circumstances should you independently alter the dosages of any drugs prescribed by your physician.
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• Consult your physician before using this device if any of the following
or similar conditions are present: arrhythmias such as atrial or ventricular
premature beats or atrial fibrillation, arterial sclerosis, poor perfusion
,
diabetes, age, pregnancy, preeclampsia, renal diseases. Motion during
measurement, including trembling or shivering may affect the measurement.
• Though not for use with children under 12, ensure that any children
around this device are supervised; some parts are small enough to be
swallowed.
DO NOT:
Use this device if you think it is damaged or anything appears unusual
(e.g. sporadic operation, open packaging upon purchase).
Use the displayed pulse for checking the frequency of heart pacemakers
as this device is not suitable for this action.
Open/modify this device; inaccuracy and/or harmful injury may result.
Conduct many frequent measurements as this may result in harmful
injury due to blood flow interference.
Place the Cuff over a wound as this may cause further injury.
Place and pressurize the Cuff over/near any present intravascular
access or therapy, or arteriovenous shunt, as this may cause blood
flow interference and result in harmful injury.
Place and pressurize the Cuff over a limb near the side of a mastectomy
as this may cause harmful injury.
Use the Blood Pressure Monitor on a limb simultaneously with other
medical equipment on the same limb due to possible interference with
such medical equipment.
Maintain pressure in the Cuff applied to the limb for a prolonged
amount of time. Ensure that circulation in the limb is not impaired by
checking circulation if prolonged/repeated exposure to pressure
occurs.
Service the device when being used or when power is supplied. When
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the device is not in use and power is removed, batteries may be
replaced by the user. No other parts/components are accessible.
CAUTION – Potentially hazardous situation that if not
may result in minor/moderate injury, property damage,
avoided
and/or
damage to the device
• This device contains sensitive electronics 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. Move the device to another
loca
tion if interference is determined.
• When not using the Blood Pressure Monitor for extended lengths of
time, remove the batteries to avoid potential battery leakage and damage
to the monitor.
• When replacing the batteries, ensure all the batteries are replaced
simultaneously to avoid battery damage and potential damage to the
monitor. Microlife USA does not recommend using rechargeable batteries.
• To avoid inaccurate measurements and to lessen any discomfort from
Cuff pressure, ensure the Cuff is placed correctly on the limb and fits
correctly when snug (not tight), as indicated by markings with the Cuff.
Consult your physician in cases of frequent irregular heartbeat detections.
•
• This Risk Indicator feature is provided in order to help you understand
your potential blood pressure risk. However, this feature is neither a
diagnosis nor a substitute for a medical examination. It is important to
consult with your physician to determine your risk.
DO NOT:
Drop this device or expose it to strong vibrations; sensitive compo-
nents may be affected resulting in inaccuracies and/or operational
issues.
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Use the Blood Pressure Monitor outside of its specified operation
temperature
and humidity rating, or if stored outside of its specified
storage temperature and humidity rating. Avoid storage in direct sunlight.
Use this device in a moving vehicle; inaccurate measurements may result.
Use third party accessories. Only use Microlife authorized accessories,
such as cuffs or AC adapters, as those not approved for use with the
device may provide inaccurate measurements, injury, and/or damage
the device.
STANDARDS
In addition to the standards stated in the Instruction Manual:
• This medical device is compliant with medical device and non-invasive
blood pressure monitor standards IEC 60601-1, IEC 60601-1-2, IEC
60601-1-11, and AAMI/ANSI/IEC 80601-2-30, and
• Electromagnetic standards IEC 60601—1-2, along with FCC Part 15, and
• Clinical Testing per standard ISO 81060-2:2013 was conducted on
blood pressure device using the same measurement technology.
Please note: According to international standards, your monitor should be
checked for accuracy every 2 years.
TYPE
IP20: Protected against solid foreign particles with a diameter of
more than 12.5 mm, no protection against water.
Keep Dry.
Type BF Applied Part
Expected Life
Monitor 5 Years
Cuff 2 Years
Batteries and electronic instruments must be disposed of in accordance
with the locally applicable regulations, not with domestic waste.
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BHS
The B.H.S. (British Hypertension Society) clinical protocol was used to
measure the accuracy of this product. Blood pressure units using the
same measurement technology are graded "AA" for systolic/diastolic
accuracy by independent investigators using the BHS protocol. This is the
highest grading available for blood pressure monitors. Please see
bhsoc.org for more information.
FCC
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. Changes or
modifications to the product are not approved by Microlife USA and could
void the user's authority to operate the equipment under FCC jurisdiction.
This equipment has been verified 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 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
on and off, the user is encouraged to try to correct the interference by
increasing the distance between the product and the affected device; or if
applicable, reorientation the receiving antenna, or moving the product’s
power plug to another receptacle.
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Wrist Blood Pressure Monitor
Instruction Manual
Table of contents
1. Introduction
1.1. Features of the Wrist Blood Pressure Monitor
1.2. Important information about self-measurement
2. Important information about 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?
3. Components of your blood pressure monitor
4. Using your blood pressure monitor for the first time
4.1. Installing the batteries
5. Taking a blood pressure 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. Irregular heartbeat detection
5.7. Memory – recalling the last measurement
6. Battery charge indicator
7. Error messages/troubleshooting
8. Care and maintenance
9. Limited Warranty
10. Technical specifications
11. How to contact us
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1. Introduction
1.1. Features of the Wrist Blood Pressure Monitor
This blood pressure monitor (with irregular heartbeat detection) 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 additional questions on the subject of blood
pressure and its measurement, please contact your doctor.
Attention!
1.2. Important information about self-measurement
• Self-measurement is a means of monitoring blood pressure. It should
not be confused with 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, 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.
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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 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 very high if your diastolic pressure is above 100 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 your body.
If your systolic blood pressure values are between 140 mmHg and 159
mmHg and/or the diastolic blood pressure values are between 90 mmHg
and 99 mmHg, consult your physician. Regular self-checks are necessary.
If you have blood pressure values that are too low (i.e., systolic values
under 105 mmHg and/or diastolic values under 60 mmHg), consult your
physician.
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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 (in adults) have
been established by the U.S. National Institutes of Health JNC7, 2003.
Category Systolic Diastolic
(mmHg) (mmHg)
Normal Self-Check <120 and <80
Pre-Hypertension 120 - 139 or 80 - 89
Stage 1 Hypertension 140 - 159 or 90 - 99
Stage 2 Hypertension
≥160 or ≥100
Additional 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 physician.
• Correctly measured diastolic blood pressure values above 120 mmHg
require immediate medical treatment.
This device is not intended for use on children 12 years of age or
younger.
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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 differenti-
ate 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.
2) Previous illnesses
Follow consistently any medical instructions for treating illness such as:
•
• Diabetes (diabetes mellitus)
• Fat metabolism disorder
• Gout
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3) Habits
• Give up smoking completely.
• Drink only moderate amounts of alcohol.
• Restrict your caffeine consumption (e.g., coffee).
4) Physical constitution
• After a preliminary medical examination, do regular 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. He will advise you
regarding the type and extent of exercise that is appropriate for you.
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3. Components of your blood pressure monitor
The illustration shows your blood pressure monitor, consisting of:
LCD
ON/OFF/START
Button
Universal Size
Wrist Cuff
Battery
Cover
Fits wrist size 13.5-19.5 cm (5.3"-7.7")
4. Using your blood pressure monitor for the first time
4.1. Installing the batteries
After you have unpacked your device, install the batteries. The battery
compartment is located on the underside of the device.
a) Remove the battery cover.
b) Install the batteries (2 x size AAA 1.5 V), following the indicated polarity.
c) If the battery warning appears in the display, the batteries are
discharged and must be replaced with new ones.
Attention:
• Please use «AAA» Long-Life or Alkaline 1.5 V batteries and replace
them all at the same time.
• We do not recommend using rechargeable batteries with this device.
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5. Taking a blood pressure measurement
Please note: You should always be seated before and during the
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 5
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 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 wrist artery lies considerably lower (higher) than the heart, an
erroneously higher (lower) blood pressure will be measured. (Each 15 cm/6"
difference in height results in a measurement error of 10 mmHg.)
• 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.
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5.3. Fitting the cuff
0.5 - 1.0 cm
(
¼” - ½”)
a) Remove all objects and jewelry (e.g., wrist-
watch) from the wrist in use. This is
normally the left wrist. Put the cuff over the
wrist with the monitor face on the inside of
the wrist.
b) The distance between the cuff and the hand
should be approx. 10 mm (½").
c) Secure the cuff with the hook and loop fas-
tener so that it lies comfortably and not too
tight. No space should remain between the
cuff and the wrist.
d) Support the arm with a small cushion, or the
case, so that the cuff rests at about the same
height as the heart. Remain still for 5
minutes
before beginning the measurement.
5.4. Measuring procedure
After the cuff has been appropriately
positioned the measurement can begin. Remain
still during your measurement, do not flex muscles.
a) Remain seated quietly for 5 minutes before
you begin the measurement.
b) Press the ON/OFF button to begin. After
pressing the ON/OFF button you will hear a
series of short beeps and the pump begins to
inflate the cuff. On the display, the increasing
cuff pressure is continually shown.
c) After reaching the proper inflation pressure,
the pump stops and the pressure slowly falls.
The cuff pressure is displayed during the
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Pulse Detected -
Unit measuring
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