microlife BP3AQ1-1 Automatic Blood Pressure Monitor Instruction Manual

Microlife BP3AQ1-1 Automatic Blood Pressure Monitor Instruction Manual

Important Product and Safety Information
Follow Instructions for Use. This document provides important product operation and safety information regarding this Blood Pressure Monitor. Please read this document thoroughly before using the device and keep for future reference.

This blood pressure monitor is an automatic digital blood pressure measuring device for use by adults 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.
• 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 additional 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 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.

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 60601-111, 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.

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.

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 additional 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.

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 independently 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.

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.
• 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.

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 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 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.

3. Components of your blood pressure monitor

a) Measuring unit

b) Upper arm cuffs:
The cuff is for arm circumference 22­32 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 additional information.

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.

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.

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 20­40 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.

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 closer to your lower arm.

• c) Align the cuff on the arm as illustrated. Make certain 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 pinkie 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.

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).

5.4. Measuring procedure

After the cuff has been appropriately positioned the measurement can begin. Remain still during your measurement, do not flex muscles.

• a) Remain seated quietly for 5 minutes before you Pressure begin the measurement.
• b) Press the START/STOP button. After a series of short beeps, the pump begins to inflate the cuff. On the display, the increasing cuff pressure is continually displayed.
• c) When the device has detected your pulse, the Measuring heart symbol in the display begins to blink.
• d) After automatically reaching an individual pressure, the pump stops and the pressure slowly falls. The cuff pressure is displayed during the measurement.
• e) When the measurement has been concluded, the air will automatically release from the cuff. The measured systolic and diastolic blood pressure values, as well as the pulse, are now displayed.
• f) The measurement results are displayed until you switch the device off. If no button is pressed for 1 minute, the device switches off automatically.

5.5. Memory – displaying the last measurement

The measured result is stored in the instrument until a new measurement is carried out or the batteries are removed. You can call up the stored value at any time by holding the START/STOP button for at least 3 seconds while the device is off.

5.6. Discontinuing a measurement

If it is necessary to interrupt a blood pressure measurement for any reason (e.g., the patient feels unwell), the START/STOP button can be pressed at any time. The device then immediately lowers the cuff pressure automatically and enters sleep mode.

6. Error messages/troubleshooting

If an error occurs during a measurement, the measurement is discontinued and a corresponding error code is displayed (example: Error no.2).

*If this or any other problem occurs repeatedly, please consult your doctor.

Other possible errors and their solutions

If problems occur when using the device, the following points should be checked and, if necessary, the corresponding measures are to be taken:

7. Care and maintenance

• a) The cuff contains a sensitive airtight bubble.
  Handle this cuff carefully and avoid all types of stress through twisting or buckling.

• b) Clean the device with a soft, dry cloth. Do not use gas, thinners or similar solvents. Spots on the cuff can be removed carefully with a damp cloth and soapsuds. Do not wash the cuff in a dishwasher, clothes washer or submerge it in water.

• c) Handle the tube carefully. Do not pull on it. Do not allow the tubing to kink and keep it away from sharp edges.

• d) Never open the monitor. This voids the manufacturer’s warranty.

8. Limited warranty

Your Automatic Blood Pressure Monitor is warrantied for 5 years by Microlife USA Inc, against manufacturer defects for the original purchaser only, from date of purchase.

The 5 year warranty applies to the monitor only. The following accessory is warranted for 1 year: cuff. Batteries are not covered by this warranty. There are no user serviceable parts inside.

The warranty does not apply to consequential and incidental damages, or damage caused by batteries, improper handling, and accidents. Professional use, not following the operating instructions, and alterations made to the monitor or accessory by third parties, are also not included in this warranty. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you.

Microlife USA Inc will investigate your concern. A monitor or accessory as defined by this warranty, determined to be out of specification, will be replaced and shipped to you at no cost. A monitor or accessory as defined by this warranty, determined to be within specification, will be returned to you with a report of findings, at no cost.

Please use the customer service contact information to reach Microlife USA Inc. regarding any warranty concerns. We ask that you please contact us before sending any product back in order to better identify, and more quickly process, your concern.

9. Technical specifications:

Weight: . . . . . . . . . . . . . . . . . . . . . . . . . . . .400 g (including batteries)
Dimensions: . . . . . . . . . . . . . . . . . . . . . . . .140 x 110 x 70 mm
Storage temperature: . . . . . . . . . . . . . . . .-4 to 131°F (-20 to 55°C)
Humidity: . . . . . . . . . . . . . . . . . . . . . . . . . . .15 to 90% relative humidity maximum
Operating temperature: . . . . . . . . . . . . . .50 to 104°F (10 to 40°C)
Display: . . . . . . . . . . . . . . . . . . . . . . . . . . . .LCD (Liquid Crystal Display)
Measuring method: . . . . . . . . . . . . . . . . . .Oscillometric
Pressure sensor: . . . . . . . . . . . . . . . . . . . .Capacitive
Measuring range:
SYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60 to 255 mmHg
DIA: . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40 to 200 mmHg
Pulse: . . . . . . . . . . . . . . . . . . . . . . . . . . .40 to 299 mmHg
Cuff pressure display range: . . . . . . . . . .0-299 mmHg
Memory: . . . . . . . . . . . . . . . . . . . . . . . . . . .Automatically stores last measurement
Measuring resolution: . . . . . . . . . . . . . . .1 mmHg
Accuracy: . . . . . . . . . . . . . . . . . . . . . . . . . .Pressure within ± 3 mmHg or 2%
of reading >200mmHg Pulse ± 5 % of the reading
Power source: . . . . . . . . . . . . . . . . . . . . . .4 AA batteries, 1.5 V
Accessories: . . . . . . . . . . . . . . . . . . . . . . .regular cuff for arm circumference 9.5″-13.25″

Technical alterations reserved. Made in China

10.How to contact us:

Distributed by:
Microlife USA, Inc. 1617 Gulf to Bay Blvd., 2nd Floor Clearwater, FL 33755

Toll Free Help Line: 1-800-568-4147
Email: custserv@microlifeusa.com
www.microlifeusa.com

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