microlife BP3AQ1-1 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; 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.
• 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.
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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 additonal injury. Place and pressurize the Cuff over/near any present intravascular access or
therapy, or arteriovenous shunt, as this may cause blood flow interference and result in harmful injury.
Place and pressurize the Cuff over a limb near the side of a mastectomy as
this may cause harmful injury.
Use the Blood Pressure Monitor on a limb simultaneously with other med-
ical 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 accuracy. Move the device to another location if interference is determined.
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• 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.
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 tempera-
ture 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 60601-1­11, 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.
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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.
This equipment has been verified to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to pro­vide reasonable protection against harmful interference in a residential instal­lation. This equipment generates uses and can radiate radio frequency energy and, if not used in accordance with the instructions, may cause harmful inter­ference to radio communications. However, there is no guarantee that interfer­ence will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment on and off, the user is encouraged to try to correct the interference by increasing the distance between the product and the affected device; or if applicable, reorientation the receiving antenna, or moving the product’s power plug to another receptacle.
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Automatic Blood Pressure Monitor Instruction Manual
Table of contents
1. Introduction
1.1. Features of your blood pressure monitor
1.2. Important information about self-measurement
2. Important information on blood pressure and its measurement
2.1. How does high/low blood pressure arise?
2.2. Which values are normal?
2.3. What can be done if regular high/low values are obtained?
3. Components of your blood pressure monitor
4. Operation of your blood pressure monitor
4.1. Inserting the batteries
4.2. Cuff tube connection
4.3 Using an AC Adapter (not included)
5. Measurement procedure
5.1. Before measurement
5.2. Common sources of error
5.3. Fitting the cuff
5.4 Measuring procedure
5.5. Memory–displaying the last measurement
5.6. Discontinuing a measurement
6. Error messages/troubleshooting
7. Care and m aintenance
8. Limited warranty
9. Technical specifications
10.How to contact us
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1. Introduction
1.1. Features of your blood pressure monitor
Your blood pressure monitor is a fully automatic digital blood pressure measur­ing device for use by adults on the upper arm at home or in your doctor’s/nurse’s office. It enables very fast and reliable measurement of the systolic and diastolic blood pressure as well as the pulse by way of the oscillo­metric method. This device offers clinically proven accuracy and has been designed to be user friendly.
Before using, please read this instruction manual carefully and then keep it in a safe place. Please contact your doctor for additonal questions on the subject of blood pressure and its measurement.
Attention!
1.2. Important information about self-measurement
• Self-measurement is a way to monitor blood pressure. It is not a means for diagnosis or treatment. Unusual values must always be discussed with your doctor. Under no circumstances should you alter the dosages of any drugs prescribed by your doctor.
• The pulse display is not suitable for checking the frequency of heart pace­makers.
• In cases of irregular heartbeat, measurements made with this instrument should only be evaluated after consultation with your doctor.
Electromagnetic interference:
The device contains sensitive electronic 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.
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2. Important information on blood pressure and its measurement
2.1. How does high/low blood pressure arise?
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.
2.2. Which values are normal?
Blood pressure is too high if your diastolic pressure is above 100 mmHg and/or your systolic blood pressure is over 160 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 inde-
pendently alter the drug doses prescribed by your physician.
Which values are normal?
The following standards for assessing high blood pressure (in adults) have been established by the American Heart Association (AHA) and American College of Cardiology (ACC) in 2017.
Additonal information
• If your values are mostly normal under resting conditions but exceptionally high under conditions of physical or psychological stress, it is possible that you are suffering from so-called "labile hypertension." Consult your doctor.
• Correctly measured diastolic blood pressure values above 120 mmHg require immediate medical treatment.
This device is not intended for use on children 12 years of age or younger.
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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
2.3. What can be done if regular high or low values are obtained?
a) Consult your doctor. b) Increased blood pressure values (various forms of hypertension) are associ-
ated 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).
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
b) Upper arm cuffs:
The cuff is for arm circumference 22–32 cm or
9.5” - 13.25” (included)
Microlife sells a large cuff for arm circumference 32-42 cm or
12” - 16” (call 1-800-568-4147 or visit www.microlifeusa.com)
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. If the cuff is too small, call 1-800-568-4147 for additonal information.
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Cuff connection
START/ STOP button
LCD-display
AC/DC Power Socket
4. Operation of your blood pressure monitor
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 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.
• If the blood pressure monitor is not used for long periods, remove the batteries from the device.
• We do not recommend using rechargeable batteries.
Functional check:
Hold on the START/STOP button down to test all the display elements. When functioning correctly, many icons will appear.
4.2. Cuff tube connection
Insert the cuff tube into the opening on the left side of the instrument.
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Low Battery Indicator
4.3. Using an AC Adapter
(special accessory sold separately. Call 1-800-568-4147 to order) It is possible to operate this blood pressure instrument with an AC adaptor
(output 6 V DC / 600 mA with DIN plug). Make certain that you use an adaptor which fulfils the legal requirements and electronic requirements in the U.S. (UL standard)
a) Push the plug into the socket on the back side of the instrument. b) Push the AC adaptor into a 110 V power socket (U.S. or Canada). c) Test that power is available by pressing the START button.
Note:
• No power is taken from the batteries while the AC adaptor is connected to the instrument.
• If the power is interrupted during the measurement (e.g. by removal of the adaptor from the wall socket), the instrument must be reset by removing the plug from the instrument.
• Please consult Microlife if you have questions relating to the AC adaptor.
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5. Measurement procedure Please note: You should always be seated before and during measurement.
5.1. Before 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 sources of error
Note: Comparable blood pressure measurements always require the same conditions. Conditions should always be quiet.
• All efforts by the user to support the arm can increase blood pressure. Make sure you are in a comfortable, relaxed position and do not flex any of the muscles in the measurement arm during the measurement. Use a cush­ion for support if necessary.
• If the arm artery lies considerably lower or higher than the heart, an erro­neously high or low blood pressure will be measured. Each 15 cm (6”) dif­ference in height between your heart and the cuff results in a measurement error of 10 mmHg.
• Cuffs that are too narrow or too short result in false measurement values. Selecting the correct cuff is extremely important. Cuff size is dependent upon the circumference of the arm (measured in the center). The permissi­ble range is printed on the cuff. If this is not suitable for your use, please call 1-800-568-4147.
• A loose cuff or a sideways protruding air pocket causes false measurement values.
• With repeated measurements, blood accumulates in the arm, which can lead to false results. Consecutive blood pressure measurements should be repeated after a 1 minute pause in order to allow the accumulated blood to flow away.
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5.3. Fitting 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 left arm through cuff so that the tube is clos-
er to your lower arm.
c) Align the cuff on the arm as illustrated. Make cer-
tain that the lower edge of the cuff, 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 white arrow on the edge of the cuff (Artery Mark) must lie over the artery which runs down the inner side of the arm.
TIP: Align 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.
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½
9.5” - 13.25”
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