microlife BP3MY1-1P Wrist Blood Pressure Monitor Instruction Manual

microlife BP3MY1-1P Wrist 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 mea-suring device for use by adults on the wrist 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 wrist; ½ inch from the hand. 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 circum-stances should you independently alter the dosages of any drugs pre-scribed 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.

DO NOT:

• Use this device if you think it is damaged or anything appears unusual (e.g. sporadic operation, open packaging upon purchase).
• Use the displayed pulse for checking the frequency of heart pacemakers as this device is not suitable for this action.
• Open/modify this device; inaccuracy and/or harmful injury may result.
• Conduct many frequent measurements as this may result in harmful injury due to blood flow interference.
• Place the Cuff over a wound as this may cause further injury.
• Place and pressurize the Cuff over/near any present intravascular access or therapy, or arteriovenous shunt, as this may cause blood flow interference and result in harmful injury.
• Place and pressurize the Cuff over a limb near the side of a mastectomy as this may cause harmful injury.
• Use the Blood Pressure Monitor on a limb simultaneously with other medical equipment on the same limb due to possible interference with such medical equipment.
• Service the device when being used or when power is supplied. When  the device is not in use and power is removed, batteries may be replaced by the user. 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.

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.

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 instruc-tions, 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.

Introduction

Your automatic blood pressure monitor
This blood pressure monitor (with irregular heartbeat detection) is a fully automatic, digital blood pressure measuring device for use on the wrist. This monitor enables very fast and reliable measurement of your systolic and diastolic blood pressure as well as pulse by way of the oscillometric method of measuring. This device offers a very high and clinically tested measurement accuracy and is designed for maximum user-friendliness. Before using it, please read through this instruction manual carefully and keep it in a safe place. For additional questions on the subject of blood pressure and its measurement, 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 ner- vous 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 way of 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). Your 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 ves-sels 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 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.

Category| Systolic

(mm Hg)

| Diastolic

(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

Additional information

•  This chart reflects a 2017 update to blood pressure standards.
•  If your values are mostly normal under resting conditions but excep-tionally high under conditions of physical or psychological stress, it is possible that you are suffering from so-called “labile hypertension.” Consult your physician.

What can I do to change my blood pressure?

•  Consult your physician.
•  Increased blood pressure values (various forms of hypertension) are associated with considerable health risks over time. Arterial blood ves-sels in your body are endangered due to constrictions caused by deposits in the vessel walls (arteriosclerosis). A deficient supply of blood to important organs (heart, brain, muscles) can result. Further-more, the heart will become structurally damaged with increased blood pressure values.
• There are many different causes of high blood pressure. We differenti-ate between the common primary (essential) hypertension and sec-ondary hypertension. Secondary hypertension can be ascribed to spe-cific organ malfunctions. Please consult your physician for information about the possible origins of your own increased blood pressure values.
• There are measures 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
   Follow consistently any 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. He will advise you regarding the type and extent of exercise that is appropriate for you.

Components of your blood pressure monitor

The illustration shows your blood pressure monitor, consisting of:

How do I get started?

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

• Remove the battery cover.
• Install the batteries (2 x size AAA 1.5 V), following the indicated polarity.
•  If the battery warning appears in the display, the batteries are discharged and must be replaced with new ones.

Attention:

•  Please use AAA Long-Life or Alkaline 1.5 V batteries and replace them all at the same time.
•  We do not recommend using rechargeable batteries with this device.

How do I take a measurement?

Please note: You should always be seated before and during the measurement.
Preparing to take a measurement

•  Avoid eating, smoking as well as all forms of exertion directly before your measurement. These factors influence the measurement result. Relax by sitting in an armchair in a quiet atmosphere for about 5 minutes before your measurement.
•  Always measure on the same wrist (normally left).
•  Compare readings at the same time of day, since your blood pressure changes during the course of the day.

Common errors
Note: Comparable blood pressure measurements always require the same conditions. These are normally always quiet conditions.

•  All efforts 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 wrist artery lies considerably lower (higher) than the heart, an erroneously higher (lower) blood pressure will be measured. (Each 15 cm/6″ difference in height results in a measurement error of 10 mmHg.)
•  A loose cuff causes false measurement values.
•  With repeated measurements, blood can accumulate in the respective arm, which can lead to false results. Correctly executed blood pressure measurements should therefore first be repeated after a 1 minute pause or after the arm has been held up in order to allow the accumulated blood to flow away.

Using the cuf

•  Remove all objects and jewelry (e.g., wrist-watch) from the wrist in use. This is normally the left wrist. Put the cuff over the wrist with the monitor face on the inside of the wrist.
•  The distance between the cuff and the hand should be approx. 10 mm (½”).
•  Secure the cuff with the hook and loop fas-tener so that it lies comfortably and not too tight. No space should remain between the cuff and the wrist.
•  Support the arm with a small cushion, or the case, so that the cuff rests at about the same height as the heart. Remain still for 5 minutes before beginning the measurement.

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

• *  Remain seated quietly for 5 minutes before you begin the measurement.

  •  Press the ON/OFF button to begin. After pressing the ON/OFF button you will hear a series of short beeps and the pump begins to inflate the cuff. On the display, the increasing cuff pressure is continually shown.
  •  After reaching the proper inflation pressure, the pump stops and the pressure slowly falls. The cuff pressure is displayed during the measurement. When the device has detected the pulse, the heart symbol in the display begins to blink.

d) When the measurement has been concluded, air in the cuff is released. The measured systolic and diastolic blood pressure values as well as the pulse are now displayed. (Pulse=number of heartbeats each minute) Example (Fig.): Systolic 118, Diastolic 73, Pulse 75. The measurement results are displayed for about one minute.

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

Irregular heartbeat detection

This symbol pulse indicates that certain pulse irregularities were detected during the measurement. In this case, the result may deviate from your normal basal blood pres- sure – 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 measure- ments taken daily), we advise you to tell your doctor.
Please show your doctor the following explanation:

Information for the doctor 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 measurement, the irregular heartbeat symbol is displayed after the measurement. If the symbol appears more frequently (e.g., several times per week on measurements performed daily) or if it suddenly appears more often than usual, we recommend the patient to seek medical advice.
Memory: recalling the last measurement
This blood pressure monitor stores the last measurement in memory. To recall the last measurement:

•  Press and hold the ON/OFF button for 5 seconds and release.
•  The LCD test screen will appear for one second, followed by the last measurement taken.
• If your last measurement included an irregular heartbeat, the icon will appear along with the measurement.

Battery change indicator

Batteries almost discharged

When the batteries are approximately 75% used, the battery symbol will flash 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 at the bottom of the instru-ment.
2. Replace all of the batteries at the same time – ensure they are installed correctly, as shown on the symbols in the compartment.
3. The memory retains all values although date and time must be reset – the year number will flash automatically after batteries are replaced.
4. To set date and time, follow the procedure described in Section 4.2.

Note:

•  Use two new, Long-Life 1.5 V AAA batteries.
•  Do not use batteries beyond their expiration date.
•  If the monitor is not going to be used for a prolonged peri-od, the batteries should be removed.
•  We do not recommend using rechargeable batteries.

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).

Other possible malfunctions and 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.  Do not store the unit under direct sunlight, at a high temperature, or in high humidity or dust. Performance may be degraded.
2. The cuff contains a sensitive air-tight bubble. Handle this cuff carefully and avoid all types of stress through twisting or buckling.
3. 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 mild liquid dish soap. Do not wash the cuff in a dishwasher, clothes washer, or submerge in water.
4. Handle the tube carefully. Do not pull on it. Do not allow the tubing to kink and keep it away from sharp edges.
5. Never open the monitor. This voids the manu-facturer’s warranty.

Limited warranty

Your Automatic Wrist Blood Pressure Monitor is warrantied for 5 years by Microlife USA Inc, against manufacturer defects for the original pur-chaser only, from date of purchase.
The 5 year warranty applies to the monitor and 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. Profes-sional 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 inciden-tal 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 con-tact 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:…………………………………150 g (with batteries)

• Size:……………………………………..81 x 65 x 28 mm

• Storage temperature:……………..-20 to +55°C (-4 to +131°F)

• Humidity:……………………………….15 to 90% relative humidity noncondensed

• 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 199 per minute

• Cuff pressure display range:……0-299 mmHg

• Memory:………………………………..Automatically stores the last measurement

• Measuring resolution:…………….1 mmHg

• Accuracy:………………………………Pressure within ± 3 mmHg or 2% of reading >200 mmHg Pulse ± 5% of the reading

• Power source:………………………..2 dry cells (batteries)

• Size AAA 1.5 V

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 www.microlifeusa.com 

References

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

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