CVS Health 800 Series User manual

This medical instrument must be
used according to instructions to
ensure accurate readings
Please Note:
Model #BP3MW1-4YCVS
CVS Item #800229
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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 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 connect-
ed via Bluetooth to a smart mobile device running the App.
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 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.
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•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 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 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.
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
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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.
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.
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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
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 communi-
cations. However, there is no guarantee that interference will not occur in a particu-
lar installation. If this equipment does cause harmful interference to radio or televi-
sion 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® Smart word mark and logos are registered trademarks owned by
Bluetooth SIG, Inc. and any use of such marks in this Blood Pressure Monitor is under
license. Other trademarks and trade names are those of their respective owners.
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Automatic Blood Pressure Monitor
Instruction Manual
Table of contents
1. Introduction
1.1.Your automatic blood pressure monitor
1.2. Gentle+™ Measurement System
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. Using the touch pad
4.3. Setting the date and time
4.4. Using the AC power adapter
4.5. Tube connection
4.6. Select the user
4.7. Select the measuring mode: standard or measurement averaging mode
4.8. Measurement averaging mode technology
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. Setting the medication reminder
5.8. Hypertension risk indicator
5.9. Irregular heartbeat detector
5.10. Battery change indicator
5.11. AM/PM Averaging
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6. Bluetooth functions & application (App)
6.1. Activating your Bluetooth®
6.2. Pairing your device
7. Error messages/troubleshooting
8. Care and maintenance
9. Limited lifetime warranty
10. Technical specifications
11. How to contact us
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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.
Before using your blood pressure monitor, please read this instruction manual
carefully to ensure correct use. If you have additional questions regarding blood
pressure measurements please contact your doctor.
1.2. Gentle+™ Measurement System
Gentle+™, our most advanced system to date, combines clinical accuracy and
premium features including:
•A quieter, more comfortable measurement experience that reduces the amount of
time your arm is under pressure. Less pressure = more comfort!
•An ergonomic cuff design that is easier to use and fits a wider range of arm sizes
(for arms 8.7”-16.5”).
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 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
particular diseases.
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2.2. Measurement guidelines
Blood pressure is very 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 medication doses prescribed by your physician.
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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.
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 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 (arterioscle-
rosis). 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.
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.
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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2) Previous illnesses
•Consistently follow all medical instructions for treating illness such as:
•Diabetes (diabetes mellitus)
•Fat metabolism disorder
• Gout
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 regard-
ing 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
Cuff Socket
Time/Date
Button
ON/OFF/
START/STOP
Button
Bluetooth®Switch
Memory
Recall Button
AC Adapter
Port
Hypertension
Risk Indicator
User 1 & 2
Pause
Memory
Bluetooth®
Battery Indicator
Medication Alarm
Evening Readings
Heartbeat
Morning Readings
Date/Time
Systolic
Diastolic
Pulse
MAM
Irregular Heartbeat
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b) Wide range soft cuff:
For arm circumference 22 cm - 42 cm (8.7” - 16.5”)
If you ever need to buy a replacement cuff, call
CVS/pharmacy®Blood Pressure Support toll-free at
1-866-464-6184.
Please Note:
Arm circumference should be measured with a measur-
ing 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 1-866-464-6184 for more
information.
4. How do I get started?
4.1. Inserting the batteries
After you have unpacked your device, insert the batter-
ies. The battery compartment is located on the bottom of
the device.
a) Remove the battery cover.
b) Insert the batteries (4 x AA 1.5 V), observing the
indicated polarity.
c) If a battery warning appears in the display, the batter-
ies 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 AA Long-Life or Alkaline 1.5 V batteries
and replace them all at once.
•Rechargeable batteries are not recommended for use.
•If the blood pressure monitor is not used for long
periods, remove the batteries from the device.
Low Battery Indicator
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4.2. Using the touch pad
This monitor features three touch pad "buttons" which
operate similarly to traditional buttons, but require only
a light touch of the finger to operate.
•The buttons are MEMORY, START/STOP, and TIME.
4.3. Setting the date and time
1. After the new batteries are activated, the year number
flashes in the display. You can advance the year by
pressing the "M" button. To confirm and then set the
month, press the TIME button.
2. You can now set the month using the "M" button. To
confirm and then set the day, press the TIME button.
3. Please follow the instructions above to set the day,
hour and minutes.
4. Once you have set the last minute and pressed the
TIME button, the date and time are set and the time is
displayed.
5. To change the date and time, press and hold TIME for
approximately 3 seconds until the MAM symbol and
ON/OFF flash onscreen. Release and press TIME again
and the year number will flash. Enter the new values
as described above.
START
STOP
M
TIME PM
Memory
Button
Time/Date
Button
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4.4. 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/STOP 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 instru-
ment must be reset by removing the plug from the instru-
ment.
If you have any questions regarding the AC adapter, call
CVS/pharmacy®Blood Pressure Support at
1-866-464-6184.
START
STOP
M
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4.5. Tube connection
Insert the cuff tube into the opening on the left side of the
monitor.
4.6. Select the user
This blood pressure monitor is designed to store 120
measurements for each of two users. In addition, there is a
guest mode in which results are not stored.
Before taking a measurement, be certain that the
correct user has been selected.
a) With the unit off, press and release the TIME button to
cycle through users ("1,""2" or guest mode (OFF)).
b) Press the START/STOP button to make your selection.
4.7. Select the measuring mode: standard or measurement averaging mode (MAM)
This instrument enables you to select either standard (single
measurement) or measurement averaging mode (automatic
triple measurement).
a) With the unit off, press the TIME button and hold for 3
seconds, the screen will show the current mode.
b) Press the “M” button to switch between standard and
averaging mode.
c) To select Standard mode, select off.
d) To select Averaging mode, select on.
If you select off, then only one measurement will be taken.
If you select on, the unit will inflate and deflate three times
resulting in one final average.
Guest Mode
START
STOP
M
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4.8. Measurement averaging mode technology (MAM)
•In Measurement 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/STOP button the selected Measurement 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.
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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 measure-
ment. These factors influence the measurement result. Find time to relax by sitting
in an armchair that gives back and arm support 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) and do not cross your legs during
the measurement.
•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 1-866-464-6184.
•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 in order to allow the accumulated blood to flow away.
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5.3. 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 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, with the red edge, lies approximately
½” (1 to 2 cm) above the elbow and that the tube is closer to
the inner side of the arm.
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.
d) Tighten the cuff by pulling the end and close the cuff by
affixing the hook and loop material.
e) 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.
f) Lay your arm on a table so the cuff is at the same height as
your heart. Make sure the tube is not kinked.
g) Remain seated quietly for 5 minutes before you begin the
measurement.
18
½”
8.7” - 16.5”
Brachial Artery
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