microlife BP3GY1-2N 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, including those with Diabetes
mellitus, 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
during cuff inflation. 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 connected via
®
Bluetooth
to a smart mobile device running the Microlife Connected
Health App.
This blood pressure monitor IS intended to be used:
• For self-measurement/monitoring of blood pressure and pulse in
adults, including those with Diabetes mellitus; 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 ventric-
1
ular 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 pacemak-
ers 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 mastecto-
my 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.
2
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 temper-
ature 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.
3
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.
4
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.
Trademark Usage:
Apple, the Apple logo, iPad, and iPhone are trademarks of Apple Inc.,
registered in the U.S. and other countries. App Store is a service mark of
Apple Inc.
Android and Google Play are both trademarks of Google Inc.
®
The Bluetooth
by
Bluetooth SIG, Inc. and any use of such marks in this Blood Pressure
word mark and logos are registered trademarks owned
Monitor is under license. Other trademarks and trade names are those of
their respective owners.
5
Bluetooth
®
Instruction M
Automatic
anual
Blood P
ressure Monitor
Table of Contents
1. Introduction
our autom
1.1. Y
iabetes m
D
1.2.
omponents of your blood pressure monitor
C
2.
Blood pressure m
2.1.
Blood pressure cuff
2.2.
How
3.
atic blood pressure m
ellitus validation
onitor
do I get started?
onitor
3.1. Protective screen film
3.2. Inserting the batteries
/ screen lock
itch
er sw
3.3. Pow
sing the interactive touch screen
3.4. U
3.5. Setting the date and tim
e
3.6. Select the user
andar
and monit
er
m
re
su
ement
ur
eadings
st
or
?
t
n
e
t
elect
3.7. S
rolif
ic
3.8. M
onnecting t
3.9. C
3.10.Using t
o I
d
ow
H
4.
eparing
4.1. Pr
ommon err
4.2. C
4.3. Using
t
4.4. Taking a
4.5. Memor
opping
t
4.6. S
he meas
aging Mode
er
e Av
he cuf
he AC pow
a
ke
a
t
ake a meas
to t
s
or
f
he cuf
ur
meas
iewing r
Rev
:
y
a meas
ing mode:
ur
f
er adapt
ea
m
ement
ement
ur
4.7. Hypertension risk indicator
4.8. Irregular heartbeat detector
4.9. Battery change indicator
Bluetooth® functions & application (app)
5.
5.1. Activating your Bluetooth®
5.2. Pairing your device
5.3. Unpairing your device
Error messages/troubleshooting
6.
d
Microlif
or
e Av
eraging
Mode
6
7. How is blood pressure measured?
7.1. What is blood pressure, and why does it fluctuate?
7.2. Measurement Guidelines
7.3. What can I do to change my blood pressure?
8. Care and maintenance
9. Limited warranty
10. Technical specifications
11. How to contact us
7
1. Introduction
1.1. Your Automatic Blood Pressure Monitor
Thank you for purchasing a fully automatic blood pressure monitor. Your
monitor is designed to provide fast and reliable digital readings of your
pulse, and systolic / diastolic blood pressure using the oscillometric
method on your upper arm. It offers clinically proven accuracy and has
been designed to be user friendly.
If you have additional questions regarding blood pressure measurements
please contact Microlife Customer Service at 1-800-568-4147 or contact
your doctor.
1.2. Diabetes mellitus validation
Diabetes, and stiff arteries, can make accurate blood pressure readings a
challenge. Microlife's commitment to health has led to a breakthrough
clinical validation for accurate readings in the presence of diabetes. This
innovation reinforces our commitment to quality, accuracy, and helping
you take control of your health.
Diabetes mellitus (or diabetes) is a chronic, lifelong condition that affects
your body's ability to use the energy found in food. There are three
major types of diabetes: type 1 diabetes, type 2 diabetes, and gestational
diabetes.
Note: this monitor does not measure blood glucose.
8
2. Components of your blood pressure monitor
2.1. Measuring unit
Cuff Socket
(yellow)
Hypertension
Risk Indicator
Memory
Date/Time
User Switch
Start, Stop,
Enter
AC Adapter Port
MAM mode
switch
Select 1 or 3
Measurements
Power, Screen Lock
9
STOP
START
Systolic
Diastolic
Pulse
User 1 & 2
Guest
Bluetooth®
Battery Indicator
Forward
Backward
Mem
or
y
Enter
MAM
Irregular Heartbeat
Pause
Heartbeat
Error 2
Error 3
10
2.2. Wide Range Cuff:
sure-tSFsure-t+
9”
12”
13”
16”
18”
M
L
large
medium
SF
+
For arm circumference 8.7” - 16.5 ” (22 cm - 42 cm)
If you ever need to buy a replacement cuff, call
us toll-free at 1-800-568-4147.
Anti-Slip Cuff:
Your wide range cuff is equipped with anti-slip
grips that ease the process of correctly positioning the cuff on your arm.
Cuff Sizing:
The proper fit is essential for accurate blood
pressure readings. The average arm circumference
for a woman is 11", and the average for a man is
13". This cuff can accommodate arm circumferences from 8.7" to 16.5" and fits most adults.
Arm circumference should be measured with a
measuring tape in the middle of the relaxed upper
arm. If the cuff is too small, call 1-800-568-4147
for additional information.
Note:
• Do not force cuff connection into the port
opening.
• Make sure the cuff connection is not pushed
into the AC adapter port.
11
3. How do I get started?
3.1. Protective screen film
There is a protective piece of static film covering the
monitor’s screen. Please remove it before use.
3.2. Inserting the batteries
After you have unpacked your device, insert the
batteries. The battery compartment is located on the
back 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 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.
3.3. Power switch / screen lock
To activate your monitor, push the switch
unlocked
on the right hand side of the monitor to
the unlocked position.
Low Battery Indicator
locked
12
3.4. Using the interactive touch screen
TIME PM
This monitor features an interactive
screen with 2 touch zones
similarly to traditional
buttons, but require
only a light touch of the finger to operate.
The following functions are made easier
through the interactive touch screen:
• Setting time and date
• Scrolling through memories
• Selecting the user
• Starting/stopping the blood pressure
measurement
3.5. Setting the date and time
1. After the new batteries are inserted
and the monitor is unlocked, the year
number flashes in the display. You can
advance the year by pressing the plus
or minus icon. To confirm and then set
the month, press enter.
2. You can now set the month using the
minus and plus. To confirm and then set
the day, press enter.
3. Please follow the instructions above to
set the day, hour and minutes.
4. Once you have set the last minute and
pressed enter, the date and time are
set and the time is displayed.
5. If you want to change the date and
time, press and hold the time zone
down 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 area of the touch screen.
which operate
Touch
(Enter)
(Enter)
ones
z
13
3.6. Select the user
This blood pressure monitor is designed to
store 120 measurements for each of two
users. Memories are not stored in guest mode.
Guest Mode
Before taking a measurement, be certain that
the correct user has been selected.
a) With the monitor unlocked, press and hold the user icon, then release.
b) The user icon will begin to blink. Tap again to change users.
c) To confirm your selection wait 3 seconds, or press STOP.
3.7. Select measuring mode: standard or
Microlife Averaging Mode (MAM)
This instrument enables you to select either standard
(single measurement) or measurement averaging mode
(automatic triple measurement).
a) To select Standard mode, push the switch on the side
of the monitor to Position "1."
b) To select Averaging mode, push the switch to Position
"3." Note the "MAM" icon will illuminate on the screen.
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 averaged measurement.
3.8. 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 pressing the START button 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.
14
3.9. 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.
3.10. Using the AC power adapter
You may also operate this monitor using
the included 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 pressing
the START 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.
If you have any questions regarding the
AC adapter, call us at 1-800-568-4147.
15
4. How do I take a measurement?
Please note: You should always be seated before and during
measurement.
4.1. 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 mm Hg).
4.2. 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 mm Hg.
• 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 or after your arm has
been held up in order to allow the accumulated blood to flow away.
16
4.3. Using the cuff
a) Pass the end of the cuff through the flat
metal ring so that a loop is formed. The
hook and loop material must be facing
outward. (Ignore this step if the cuff has
already been prepared.)
b) Slide the cuff onto 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 ½” (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. Check the position of the
green SIZING SEAM on the cuff. Ensure
green sizing seam overlaps green size
range bar.
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.
8.7” - 16.5”
½
Brachial Artery
”
17
e) Lay your arm on a table so the cuff is at
the same height as your heart. Make
sure your arm is relaxed and 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
measurements should be made using the same arm.
Comparable blood pressure measurements always
require the same conditions (relax for several
minutes before a reading).
Cuff on
right arm
18
4.4. Taking a measurement
After the cuff has been appropriately positioned
the measurement can begin. Remain still during
your measurement, do not flex muscles, and
refrain from talking.
a) Remain seated quietly for 5 minutes before you
begin the measurement.
b) Press the START button. After the system
check, the monitor displays OK and the pump
begins to inflate the cuff. On the display, the
increasing cuff pressure is continually shown.
c) After automatically reaching an individual
pressure, the pump stops and the pressure will
deflate slowly. The cuff pressure is displayed
during the measurement.
d) When the device has detected your pulse, the
heart symbol in the display begins to blink.
When the measurement has been concluded, the
e)
air will automatically release from the cuff. The
measured systolic and diastolic blood pressure
values, as well as the pulse, are now displayed.
f
) The measurement results are displayed until you
switch the device off. If no button is pressed for
1 minute, the device switches off automatically.
g) When the unit is set to the MAM (Microlife
Averaging Mode) setting, 3 separate measurements will take place in succession, after which
your result is calculated and displayed as a
single, averaged measurement (individual
results are not displayed). There is a 15 second
resting time between each measurement. A
count-down indicates the remaining time
between measurements.
If one of the measurements causes an error
message, it will be repeated one more time. If
any additional error occurs, the measurement
will be discontinued and error code displayed.
Pumping
Pressure
Measuring
Systolic
Diastolic
Pulse
Measurement
Complete
19
4.5. Memory: Reviewing readings
At the end of a measurement, this monitor automatically stores each result with date and time. This unit
stores 120 memories for each of 2 users.
Viewing the stored values
• With the unit unlocked, press "M." The display first shows "A," then
shows an average of all measurements stored in the unit for that
user.
• Press the plus or minus icon to scroll between stored readings.
Please note: Measurements for each user are averaged and stored
separately. Be certain that you are viewing the measurements for the
correct user.
• To exit, press STOP.
Memory full
When the memory has stored 120 results, a new,
measured value is stored by overwriting the oldest
value.
Clear all values
• If you are sure that you want to permanently
remove all stored values, hold down "M" until "CL"
appears and then release "M".
• To continue and erase the values, press "M"again
while "CL" is flashing.
• To discontinue with the clearing of memories,
press “STOP.”
• Individual values cannot be cleared.
4.6. Stopping a measurement
If it is necessary to interrupt a blood pressure
measurement for any reason (e.g., the patient feels
unwell), the “STOP” button can be pressed at any time.
The device then immediately lowers the cuff pressure
automatically and enters sleep mode.
20
4.7. Hypertension risk indicator
Dk. Orange Dk. Orange Dk. Orange Dk. Orange Dk. Orange
The bars on the left-hand edge of the display show the possible range
for a blood pressure reading. The reading can fall within the normal
(green), borderline (yellow) or danger (orange, dark orange) range.
The classification is based on standards established by the American Heart
Association (AHA) and American College of Cardiology (ACC) in 2017.
Refer to the chart in section 7.2 of this instruction manual for details of
the classifications.
A triangle is displayed to the right of the traffic light bar according to
your measurement. If the display shows a triangle in the:
• green zone, your measurement is "Normal."
• lower yellow zone, it is "Elevated."
• upper yellow zone, it is "Stage 1 Hypertensive."
• orange zone, it is "Stage 2 Hypertensive.”
• lower dark orange zone, it is "Stage 2 Hypertensive.”
• upper dark orange zone, it is "Hypertensive Crisis."
"Normal"
Blood Pressure
Reading
"Elevated"
Blood Pressure
Reading
"Stage 1 Hypertensive"
Blood Pressure
Reading
"Stage 2 Hypertensive"
Blood Pressure
Reading
"Hypertensive Crisis"
Blood Pressure
Reading
21
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