McKesson Health Mart 800 Series 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 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; ½inch 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 independ-
ently alter the dosages of any drugs prescribed by your physician.
•Consult your physician before using this device if any of the following or similar con-
ditions are present: arrhythmias such as atrial or ventricular premature beats or atri-
al fibrillation, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, preeclamp-
sia, 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 pres-
ent tubes or cables may provide a risk of strangulation.
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•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 pro-
longed/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 applica-
ble) 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 elec-
tromagnetic 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
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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 humidi-
ty 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 inaccu-
rate measurements, injury, and/or damage the device.
STANDARDS:
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 local-
ly 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 follow-
ing 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 tested and found to comply with the limits for a Class B digi-
tal 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
installed and 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 off
and on, the user is encouraged to try to correct the interference by one or more of the
following measures: 1) Reorient or relocate the receiving antenna, 2) Increase the sep-
aration between the equipment and receiver, 3) Connect the equipment into an outlet
on a circuit different from that to which the receiver is connected. And 4) Consult the
dealer or an experienced radio/TV technician for help.
This device complies with FCC radiation exposure limits set forth for an uncontrolled
environment. End users must follow the specific operating instructions for satisfying RF
exposure compliance.
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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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Premium 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. Setting the date and time
4.3. Using an AC power adapter
4.4. Tube connection
4.5. Select the user
4.6. Select the measuring mode: standard or measurement averaging mode
4.7. 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
6. Bluetooth functions & application (App)
6.1. Activating your Bluetooth®
6.2. Pairing your device
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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
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 meas-
urements 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 speed 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 your medication
doses prescribed by your physician.
Which values are normal?
The following standards for assessing high blood pressure (in adults) have been estab-
lished by the American Heart Association (AHA) and American College of Cardiology
(ACC) in 2017:
Additional information
•This chart reflects a 2017 update to blood pressure standards.
•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 suf-
fering from so-called "labile hypertension." Consult your doctor.
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Category Systolic Diastolic
(mm Hg) (mm Hg)
Normal <120 and <80
Elevated 120-129 and <80
Hypertension
Stage 1 Hypertension 130-139 or 80-89
Stage 2 Hypertension 140-179 or 90-119
Hypertensive Crisis ≥180 or ≥120
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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 endan-
gered 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 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.
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 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
Heartbeat
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Cuff Socket Memory Recall
Button
ON/OFF/START
Button
Time/Date
Button
Hypertension
Risk Indicator
AC Adapter Port
User 1 & 2
Battery Indicator
Irregular Heartbeat
Memory
Bluetooth
MAM
Date/Time
Systolic
Diastolic
Pulse
Medication Alarm
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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
Blood Pressure Support toll-free at
1-866-241-6217.
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 connec-
tion is not pushed into the AC adapter port. If the cuff is too
small, call 1-866-241-6217 for additional information.
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4. How do I get started?
4.1. Inserting the batteries
After you have unpacked 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 AA 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 AA Long-Life or Alkaline 1.5 V batteries and
replace all at the same time.
•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. 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"
b utton. 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 but-
ton, 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 button down for approximately 3 seconds until the year
number starts to flash. Now you can enter the new values as
described above.
TIME PM
-Button
Time/Date
Button
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4.3. 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 ON/OFF button.
Note:
•No power is taken from the batteries while the AC adapter is
connected to the monitor.
•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
Blood Pressure Support at 1-866-241-6217.
4.4. Tube connection
Insert the cuff tube into the opening on the left side of the monitor.
4.5. Select the user
This blood pressure monitor is designed to store 120 meas-
urements for each of two users.
Before taking a measurement, be certain that the cor-
rect user has been selected.
a) Press the "TIME/DATE" button to toggle between user 1
and user 2.
b) Press the ON/OFF button to confirm your selection.
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4.6. 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 sec-
onds, the screen will show the current mode.
b) Press the “M” button to switch between standard and aver-
aging 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.
4.7. Measurement averaging mode technology (MAM)
In Measurement Averaging Mode (MAM), 3 measurements are
automatically taken in succession and the averaged result is
displayed. Because your blood pressure constantly fluctuates,
an averaged measurement is more reliable than one produced
by a single measurement.
To use measurement averaging mode (MAM):
•Press and release the START/STOP button, and the
Measurement Averaging Mode symbol (MAM) will appear on
the display.
•A 1, 2 or 3 will appear on the display to indicate which of the
3 measurements is currently being taken.
Note: To ensure an accurate measurement, follow the detailed
instructions in Section 5.
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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 taken 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 1-866-241-6217.
•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
1/2” (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 cloth-
ing 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.
½”
8.7” - 16.5”
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