Microlife BP3AQ1-1 Bedienungsanleitung

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; ½inch 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 val-

ues 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 pre-

mature beats or atrial fibrillation, arterial sclerosis, poor perfusion, dia-

betes, age, pregnancy, preeclampsia, renal diseases. Motion during mea-

surement, 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 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 circula-

tion 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 electri-

cal 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 simulta-

neously 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 temper-

ature 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

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 measure-

ment technology are graded "AA" for systolic/diastolic accuracy by indepen-

dent 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 interfer-

ence 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 pro-

vide reasonable protection against harmful interference in a residential instal-

lation. This equipment generates uses and can radiate radio frequency energy

and, if not used in accordance with the instructions, may cause harmful inter-

ference to radio communications. However, there is no guarantee that interfer-

ence 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.

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 maintenance

8. Limited warranty

9. Technical specifications

10.How to contact us

1. Introduction

1.1. Features of your blood pressure monitor

Your blood pressure monitor is a fully automatic digital blood pressure measur-

ing 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 oscillo-

metric 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 pace-

makers.

•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 tele-

phones, 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 activi-

ty. 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 pre-

vent 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.

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 hyper-

tension. 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.

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