microlife BP3GR1-3P 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.
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,
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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:
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 additional
injury.
Place and pressurize the Cuff over/near any present intravas-
cular 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 measure-
ments may result.
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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 80601-2­30, and
• Electromagnetic standards IEC 60601—1-2 along with FCC Part 15, and
• Clinical Testing per standard ISO 81060-2:2013 was conduct­ed on blood pressure device using the same measurement technology.
Please note: According to international standards, your monitor should be checked for accuracy every 2 years.
TYPE
IP20: Protected against solid foreign particles with a
diameter of more than 12.5 mm, no protection against water. Keep Dry.
Type BF Applied Part
EXPECTED LIFE
Monitor: 5 Years Cuff: 2 Years
Batteries and electronic instruments must be disposed of in accordance with the locally applicable regulations, not with domestic waste.
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.
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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. Setting the date and time
4.3. Using an AC power adapter (not included)
4.4. Tube connection
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. Irregular heartbeat detection
5.8. Battery change indicator
6. Error messages/troubleshooting
7. Care and maintenance
8. Limited warranty
9. Technical specifications
10. 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.
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 particula
r diseases.
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
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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 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.
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.
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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2.3. What can I do to change my blood pressure?
a) Consult your doctor. b) Increased blood pressure values (various forms of hyperten-
sion) 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
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 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
3) Habits
• Give up smoking completely.
• Drink only moderate amounts of alcohol.
• Restrict your caffeine consumption (e.g., coffee).
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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
Cuff Socket
(yellow)
Time/Date
Button
POWER
Button
Memory
Recall Button
AC Adapter Port
M
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b) Wide Range Cuff:
For arm circumference 22 cm - 42 cm (8.7” - 16.5 ”)
If you need 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 additional information.
Error 3
Battery Indicator
Irregular Heartbeat
Memory
Heartbeat
Error 2
Date/Time
Systolic Diastolic
Pulse
DIA mmHg
SYS mmHg
PULSE / min
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4. How do I get started?
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 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 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.
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" 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. 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
Memory Button
Time/Date Button
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4.3. Using an AC power adapter (not included)
You may also operate this monitor using an AC adapter.
To purchase an AC adapter for this unit, call 1-800-568-4147.
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 POWER 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 an AC adapter, call us at 1-800-568-4147.
4.4. Tube connection
Insert the yellow cuff tube connec­tor into the
yellow socket on the left
side of the instrument.
M
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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
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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.
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 arm through cuff until the
bottom edge is about 1/2” (1 to 2 cm) above your elbow. Adjust the cuff until it is snug against your arm without being too tight.
The rubber tube should be on the inside of your arm extending downward to your hand.
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 size range indica­tor on the cuff. The arrow should point within the size range on the inside of the cuff.
½
8.7” - 16.5”
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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 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
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