microlife BP3GQ1-3P Blood Pressure Monitor Instruction Manual

microlife BP3GQ1-3P Blood Pressure Monitor

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 measur-ing 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 oscillo-metric 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, 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 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 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.
• This Risk Indicator feature is provided in order to help you understand your potential blood pressure risk. However, this feature is neither a diagnosis nor a substitute for a medical examination. It is important to consult with your physician to determine your risk

DO NOT

• Drop this device or expose it to strong vibrations; sensitive components may be affected resulting in inaccuracies and/or operational issues.
• Use the Blood Pressure Monitor outside of its specified operation temperature and humidity rating, or if stored outside of its specified storage temperature and humidity rating. Avoid storage in direct sunlight.
• Use this device in a moving vehicle; inaccurate measurements may result.
• Use third party accessories. Only use Microlife authorized accessories, such as cuffs or AC adapters, as those not approved for use with the device may provide inaccurate measurements, injury, and/or damage the device

STANDARDS
In addition to the standards stated in the Instruction Manual:

• This medical device is compliant with medical device and non-invasive blood pressure monitor standards IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and AAMI/ANSI/IEC 80601-2-30, and
• Electromagnetic standards IEC 60601-1-2 along with FCC Part 15, and
• Clinical Testing per standard ISO 81060-2:2013 was conducted on blood pressure device using the same measurement technology.

Please note: According to international standards, your monitor should be checked for accuracy every 2 years

Introduction

Your automatic 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 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 your blood pressure monitor, please read this instruction manual carefully and then keep it in a safe place for future reference. If you have additional questions regarding blood pressure measurements please contact your doctor.

How is blood pressure measured

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 (systolicblood 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.

Measurement guidelines
Blood pressure is very high if your systolic blood pressure is over 140 mmHg and/or your diastolic pressure is above 90 mmHg, while at rest. In this case, please consult your doctor immediately. Long-term values at this level endanger your health due to continual damage to the blood vessels in your body. Should the systolic blood pressure values lie between 130 mmHg and 139 mmHg and/or the diastolic blood pressure values lie between 80 mmHg and 89 mmHg, consult your doctor. Regular self-checks will be 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 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 exception-ally high under conditions of physical or psychological stress, it is possible that you are suffering from so-called “labile hypertension.” Consult your doctor.

What can I do to change my blood pressure?

1. Consult your doctor.
2. 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.
3. There are many different causes of high blood pressure. We differenti-ate between the common primary (essential) hypertension and second-ary 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.
4. There are measures which you can take to reduce and even prevent high blood pressure. These measures must be permane nt lifestyle changes.

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.

Previous illnesses

• Consistently follow all medical instructions for treating illness such as:
• Diabetes (diabetes mellitus)
• Fat metabolism disorder
• Gout

Habits

• Give up smoking completely.
• Drink only moderate amounts of alcohol.
• Restrict your caffeine consumption (e.g., coffee).

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.

Components of your blood pressure monitor

Measuring unit.

Wide Range Cuff:
For arm circumference 22 cm – 42 cm (8.7” – 16.5 ”) If you ever need to buy 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.

How do I get started

Inserting the batteries
After you have unpacked your device, insert the batteries. The battery compartment is located on the bottom of the device.

1. Remove the battery cover.
2. Insert the batteries (4 x size AA 1.5 V), observing the indicated polarity.
3. 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 recharge-able batteries with this device.

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.

Using the 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.

1. Ensure that the AC adapter and cable are not damaged.
2. Plug the adapter cable into the AC adapter port on the right side of monitor.
3. Plug the AC adapter into a 110 V power socket (U.S. or Canada).
4. 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 instru-ment 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.

Tube connection
Insert the yellow cuff tube connector into the yellow socket on the left side of the instrument If your cuff connector is another color, please contact customer service as additional steps are needed to obtain an accurate reading.

How do I take a measurement

Please note : You should always be seated before and during measurement.

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).

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 measure-ment 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 to allow the accumulated blood to flow away.

Using the cuff

1. 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.)
2. Slide left arm through cuff until the bottom edge is about 1/2” above your elbow. 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.
3. 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.
4. 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.
5. Lay your arm on a table so the cuff is at the same height as your heart. Make sure the tube is not kinked.
6. Remain seated quietly for five 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).

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

1. Remain seated quietly for 5 minutes before you begin the measurement.
2. Press the POWER button. After the system check, the monitor displays OK and the pump begins to inflate the cuff. On the display, the increasing cuff pressure is continually shown.
3. After automatically reaching an individual pressure, the pump stops and the pressure slowly falls. The cuff pressure is displayed during the measurement.
4. When the device has detected your pulse, the heart symbol in the display begins to blink.
5. 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.
6. The measurement results are displayed until you switch the device off. If no button is pressed for 1 minute, the device switches off automatically.

Memory: reviewing readings
At the end of a measurement, this monitor automatically stores each result with date and time. This unit stores 60 memories.

Viewing the stored values
With the unit off, press the “M” button. The display first shows “A,” then shows an average of all measurements stored in the unit. Pressing the “M” button again displays the previous value. To view a particular stored memory, press and hold the “M” button to scroll to that stored reading.

Memory full
When the memory has stored 60 results, a new, measured value is stored by overwriting the oldest value.

Clear all values
If you are sure that you want to permanently remove all stored values, hold down the “M” button (the instrument must have been switched off beforehand) until “CL” appears and then release the button. If you do not want to clear the values, press the POWER button. To permanently clear the memory, press the “M” button while “CL” is flashing. Individual values cannot be cleared.

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

Hypertension risk indicator
The colored indicator on the left-hand edge of the display has been designed to provide a quick visual representation of your blood pressure. Once a measurement has been completed, a black triangle will display onscreen next to the colored hypertension indicator. The height of the black triangle will show if the measurement is within the normal (green) borderline (yellow/orange) or danger (red) range. This classification is based on standards established by the American Heart Association (AHA) and American College of Cardiology (ACC) in 2017.

A triangle is displayed to the right of the traffic light bar according to you measurement. If the display shows a triangle in the:

• green zone, your measurement is “Normal.”
• lower yellow zone, it is “Elevated.”
• upper yellow zone, it is “Stage 1 Hypertensive.”
• orange zone, it is “Stage 2 Hypertensive.”
• lower red zone, it is “Stage 2 Hypertensive.”
• upper red zone, it is “Hypertensive Crisis.”

Irregular heartbeat detector
The appearance of this symbol indicates that certain pulse irregularities were detected during the measure- ment. In this case, the result may deviate from your normal basal blood pressure – repeat the measurement. In most cases, this is no cause for concern. However, if the symbol appears on a regular basis (e.g., several times a week with measurements taken daily), we advise you to tell your doctor. Please show your doctor the following explanation:

Information on frequent appearance of the irregular heartbeat symbol
This instrument is an oscillometric blood pressure monitor device that also analyzes pulse frequency during measurement. The instrument is clinically tested. If pulse irregularities occur during the measurement, the irregular heartbeat symbol is displayed with the measurement. If the symbol appears frequently or if it suddenly appears more often than usual, we recommend the patient seek medical advice. The instrument does not replace a cardiac examination but serves to detect pulse irregularities at an early stage.

Battery change indicator

Batteries almost discharged
When the batteries are approximately 75% used, the battery symbol will flash a few times as soon as the instrument is switched on (if at least one of the batteries still has some charge). Although the instrument will continue to measure reliably, you should obtain replacement batteries. Batteries discharged – replacements required When the batteries are discharged, the battery symbol will appear, unblinking, as soon as the instrument is switched on. You cannot take any additional measurements and must replace the batteries.

1. Open the battery compartment on the bottom of the instrument.
2. Replace all of the batteries at the same time – ensure they are correctly connected, as shown on the symbols in the compartment.
3. The memory retains all values although date and time (and possibly also set alarm times) must be reset – the year number will flash automatically after the batteries are replaced.
4. To set date and time, follow the procedure described in Section 4.2.

Note:
Use four new, Long-Life 1.5 V AA batteries. Do not use batteries beyond their expiration date. If the monitor is not going to be used for a prolonged period, the batteries should be removed.

Error messages/troubleshooting

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

Error No. Possible cause(s)/Solutions

• ERR 1The tube may have loosened, or no pulse was detected.* Ensure cuff connections are tight with proper cuff placement. See section 5.3.
• ERR 2 Unnatural pressure impulses influenced the measurement result. Reason: The arm was moved during the measurement (artefact). Repeat measurement, keeping still and quiet.
• ERR 3 Inflation of the cuff takes too long. The cuff is not correctly seated or the hose connection is not tight. Re-position cuff and repeat the measurement.
• ERR 5 The measured readings indicated an unacceptable difference between systolic and diastolic pressures. Take another reading following directions carefully. Contact your doctor if you continue to get unusual readings.
• HI The cuff pressure is too high. Relax for 5 minutes and repeat the measurement.*
• LOThe pulse is too low (less than 40). Repeat the measurement.*

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:

Care and maintenance

1. The cuff contains a sensitive airtight bubble. Handle this cuff carefully and avoid all types of stress through twisting or buckling.
2. Clean the device with a soft, dry cloth. Do not use gasoline, thinners or similar solvents. Spots on the cuff can be removed carefully with a damp cloth and soapsuds. The cuff must not be washed in a dishwasher, clothes washer or submerged in water.
3. Handle the tube carefully. Do not pull on it. Do not allow the tubing to kink and keep it away from sharp edges.
4. Never open the monitor. This voids the manufacturer’s warranty.

Limited warranty

Your Automatic Blood Pressure Monitor is warranted 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 accessories are warranted for 1 year: cuff. Batteries are not covered by this warranty. 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 below 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. This warranty gives you specific legal rights, and you may also have other rights which vary from state to state.

Technical specifications

• Weight: . . . . . . . . . . . . . . . . . . . . . . . . .346 g (with batteries)
• Size: . . . . . . . . . . . . . . . . . . . . . . . . . . .82 (W) x 136 (L) x 58 (H) mm
• Storage temperature: . . . . . . . . . . . . . .-20 to +55°C (-4° to +131°F)
• Humidity: . . . . . . . . . . . . . . . . . . . . . . .15 to 90% relative humidity maximum
• Operation temperature: . . . . . . . . . . . .10 to 40°C (50° to 104°F)
• 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 200 per minute
• Cuff pressure display range: . . . . . . . .0-299 mmHg
• Memory: . . . . . . . . . . . . . . . . . . . . . . . .Automatically stores the last 60
• measurements
• Measuring resolution: . . . . . . . . . . . . .1 mmHg
• Accuracy: . . . . . . . . . . . . . . . . . . . . . . .Pressure within ± 3 mmHg or 2% of reading >200 mmHg
• Pulse ± 5% of the reading
• Power source: . . . . . . . . . . . . . . . . . . . .a)4 AA batteries, 1.5 V
• b)AC adapter 6 V DC 600 mA (voltage 4.5 V DC to 6 V DC) not included
• Accessories: . . . . . . . . . . . . . . . . . . . . . . .Cuff type: Wide range cuff for arm
• circumference 22-42 cm (8.7”-16.5”) Storage case

How to contact us
Microlife USA, Inc. 1617 Gulf to Bay Blvd Clearwater, FL 33755

• Toll Free Help Line: 1-800-568-4147
• Email: custserv@microlifeusa.com
• Fax: (727) 451-049 www.microlifeusa.com

References

• Homepage - British and Irish Hypertension Society | Registered UK Charity No. 287635
• Microlife

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