microlife BP3GU1-8X User Manual
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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 upper arm 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. The device can be used in connection with your
personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA)
software; the memory data can be transferred to the PC by connecting the
monitor via cable with the PC.
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 upper arm; ½ inch above the elbow
over the artery as indicated on the cuff.
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.
• Consult your physician before using this device if any of the following or
similar conditions are present: arrhythmias such as atrial or ventricular
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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 and any present tubes or cables may provide a risk of
strangulation.
• Ensure the cuff tubing is not kinked during use as harmful injury may
occur due to
the effect of blood flow interference caused by high pressure
in the cuff not releasing.
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 additonal 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
the device is not in use and power is removed, cuff assembly, batteries
and AC adapter (if applicable) may be replaced by the user with
Microlife supplied replacements. No other parts/components are
accessible.
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CAUTION – Potentially hazardous situation that if not avoided
may result in minor/moderate injury, property damage, 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
location 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 components
may be affected resulting in inaccuracies and/or operational issues.
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.
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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
Batteries and electronic instruments must be disposed of in accordance
with the locally applicable regulations, not with domestic waste.
Expected Life
Monitor: 5 Years
Cuff: 2 Years
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. (Uses the
same algorithm as B.H.S. graded “AA” model number 3BT0-1)
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.
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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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Automatic Blood Pressure Monitor
Instruction Manual–Table of contents
1. Introduction
1.1. Your automatic blood pressure monitor
2. How is blood pressure measured?
2.1. What is blood pressure, and why does it fluctuate?
2.2. Measurement guidelines
2.3. What can I do to change my blood pressure?
3. Components of your blood pressure monitor
4. How do I get started?
4.1. Inserting the batteries
4.2. Power switch
4.3. Setting the date and time
4.4. Using an AC power adapter
4.5. Connecting the cuff and monitor
4.6. Select the user
4.7. Select the measuring mode: standard or Microlife Averaging Mode
4.8. Microlife Averaging Mode
5. How do I take a measurement?
5.1. Preparing to take a measurement
5.2. Common errors
5.3. Using the cuff
5.4. Taking a measurement
5.5. Memory: reviewing readings
5.6. Stopping a measurement
5.7. Hypertension risk indicator
5.8. Irregular heartbeat detector
5.9. Battery change indicator
6. Software functions
6.1. Installation and data transmission
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. Your automatic blood pressure monitor
Your blood pressure monitor is a fully automatic digital blood pressure
measuring device for use by adults on the upper arm at home or in your
doctor’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 your blood pressure monitor, please read this instruction
manual carefully and then keep it in a safe place for future reference. If
you have additional questions regarding blood pressure measurements
please contact your doctor.
2. How is blood pressure measured?
2.1. What is blood pressure, and why does it fluctuate?
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 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
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blood pressure value). At the end 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 particula
r diseases.
2.2. Measurement guidelines
Blood pressure is too high if your systolic blood pressure is over 160
mmHg and/or your diastolic pressure is above 100 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.
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 medications prescribed by your
physician.
Which values are normal?
The following standards for assessing high blood pressure (in adults) have
been established by the National Institutes of Health JNC7, 2003.
Category Systolic Diastolic
(mmHg) (mmHg)
Normal <120 and <80
Pre-Hypertension 120-139 or 80-89
Hypertension
Stage 1 Hypertension 140-159 or 90-99
Stage 2 Hypertension ≥160 or ≥100
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Additonal 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.
2.3. What can I do to change my blood pressure?
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 differenti-
ate 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 permane nt 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
• Consistently follow all 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. You must receive
advice regarding the type and extent of exercise that is appropriate for
you.
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3. Components of your blood pressure monitor
a) Measuring unit
ST
AR
T
ST
OP
M
S
TART
S
TO
P
M
Cuff Socket
(yellow)
Time/Date
Button
START/STOP/
POWER
Button
USB Port
Memory
Recall
Button
AC Adapter Port
Hypertension
Risk Indicator
User Switch
Mode Switch
Select 1 or 3
Measurements
Power Switch
Minus
Plus
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User 1 & 2
Pause
MAM
Error 3
Battery Indicator
Irregular Heartbeat
Memory
Heartbeat
Error 2
Date/Time
Systolic
Diastolic
Pulse
b) SureFit+ Cuff:
For arm circumference 22 cm–46 cm (8.7”–18.1 ”)
If you ever need to buy a replacement cuff, call
us toll-free at 1-800-568-4147.
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 1-800-568-4147 for further information.
This unit will only work accurately with the included cuff.
SYS mmHg
DIA mmHg
PULSE
min
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4. Using your blood pressure monitor for the first time
4.1. Inserting the batteries
After unpacking your device, insert the
batteries. The battery compartment is
located on the bottom of the device.
a) Remove the battery cover.
b) Insert the batteries (4 x size AAA 1.5 V),
observing the indicated polarity.
c) If a battery warning appears in the
display, the batteries are discharged and
must be replaced.
Attention!
• After the low battery indicator appears,
the device won’t function until the batteries
have been replaced.
•
Please use "AAA" Long-Life or Alkaline
1.5 V
batteries and replace them all at the
same time..
• If the blood pressure monitor is not used
for long periods, remove the batteries
from the device.
• We do not recommend using rechargeable batteries with this device.
Low Battery Indicator
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4.2. Power switch
To activate your monitor, push the switch on the right
hand side downwards to the unlock position.
4.3. Setting the date and time
1. After the new batteries are activated and
the monitor is unlocked, the year number
flashes in the display. You can advance
the year by pressing minus and plus. To
confirm and then set the month, press
TIME.
2. You can now set the month using the
minus and plus. To confirm and then set
the day, press TIME.
3. Please follow the instructions above to
set the day, hour and minutes.
4. Once you have set the last minute and
pressed TIME, the date and time are set
and the time is displayed.
5. If you want to change the date and time,
press and hold TIME for approximately 3
seconds until the year number starts to
flash. Now you can enter the new values
as described above.
6. To bypass setting date and time, press
the time.
unlocked
locked
TIME PM
Time Button
Time Button
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4.4. Using the AC power adapter
You may also operate this monitor using an
AC adapter.
Use only the included AC
adapter to avoid damaging the unit.
a) Ensure that the AC adapter and cable are
not damaged.
b) Plug the adapter cable into the AC
adapter port on the right side of monitor.
c) Plug the AC adapter into a 110 V power
socket (U.S. or Canada).
d) Test that power is available by switching
the screen lock located on the right side of
the monitor off and on. The screen display
will be visible after pressing START/STOP if
the power is available.
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.
If you have any questions regarding an AC
adapter, call us at 1-800-568-4147.
4.5. Connecting the cuff and monitor
Insert the yellow cuff tube connector into the
yellow socket on the left side of the instrument.
If your cuff connector is another color, please
contact customer service as additional steps
are needed to obtain an accurate reading.
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4.6. Select the user
This blood pressure monitor is designed to store 99
measurements for each of two users.
Before taking a measurement, be certain that
the correct user has been selected.
• User 1: slide the user switch upwards to the
User 1 icon
• User 2: slide the user switch downwards to the User 2 icon
4.7. Select measuring mode: standard or
Microlife Averaging Mode (MAM)
This instrument enables you to select either standard
(single measurement) or measurement a
veraging
mode (automatic triple measurement).
a) To select Standard mode, slide the switch on the
side of the instrument upward to Position "1."
b) To select Averaging mode, slide the switch
downward to Position "3." Note the "MAM" icon
will appear on the display.
If you select 1, then only one measurement will be
taken. If you select 3, the unit will inflate and deflate
three times resulting in one final average.
4.8. Microlife Averaging Mode (MAM)
• In Microlife Averaging Mode (MAM), three measurements are automatically taken in succession and the result is then automatically analyzed
and displayed. Because your blood pressure constantly fluctuates, a
result determined in this way is more reliable than one produced by a
single measurement.
• After adjusting the switch as described in section 4.7, the selected
Microlife Averaging Mode appears in the display as the MAM symbol.
• The bottom, right-hand section of the display shows a 1, 2 or 3 to
indicate which of the 3 measurements is currently being taken.
• There is a resting period of 15 seconds between measurements. An
hourglass will appear during this period.
3 1
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5. How do I take a measurement?
Please note: You should always be seated before and during
measurement.
5.1. Preparing to take a 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 5
minutes before your measurement.
• Remove any garment that fits closely to your upper arm.
• Always measure on the same arm (normally left).
• Compare measurements at the same time of day, since blood pressure
changes during the course of the day (as much as 20–40 mmHg).
5.2. Common errors
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 15 cm
(6”) 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 call 1-800-568-4147.
• 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 to allow the accumulated blood to
flow away.
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5.3. Using the cuff
a) The cuff is pre-formed for easier use.
Remove tight or bulky clothing from your
upper arm.
b) Wrap the cuff around your upper left arm.
The rubber tube should be on the inside of
your arm extending downward to your hand.
Make certain the cuff lies approximately
1/2” (1 to 2 cm) above the elbow.
IMPORTANT: The red strip on the edge of
the cuff (Artery Mark) must lie over the artery
which runs down the inner side of the arm.
TIP: Align red artery mark to pinky finger.
c) To secure the cuff, wrap it around your arm
and press the hook and loop material together.
d) There should be little free space between
the arm and the cuff. You should be 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.
e) Lay your arm on a table so the cuff is at the
same height as your heart. Make sure the
tube is not kinked.
f) Remain seated quietly for 5 minutes before
you begin the measurement.
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
½
”
8.7” - 18.1”
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