Microlife BP3GX1-5A Bedienungsanleitung

mportant Product and Safety nformation

Follow nstructions 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. The device can be used in connection with your

personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA)

software; the memory data can be transferred to the PC by connecting the

monitor via cable with the PC.

This blood pressure monitor S 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 S NOT intended for use with:

• Pregnancy

•Preeclampsia

• Children under 12

• Neonatal patients

WARN NG – 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

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 further injury.

Place and pressurize the Cuff over/near any present intravascular access

or therapy, or arteriovenous shunt, as this may cause blood flow interfer-

ence 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.

CAUT ON – 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 impair-

ment 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:

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

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.

Premium Automatic Blood Pressure Monitor

Instruction Manual Table of Contents

1. ntroduction

1.1. Your automatic blood pressure monitor

1.2. Gentle+ measurement system

2. How is blood pressure measured?

2.1. What is blood pressure, and why does it fluctuate?

2.2. Measurement Guidelines

2.3. What can I do to change my blood pressure?

3. Components of your blood pressure monitor

4. How do get started?

4.1. Inserting the batteries

4.2. Setting the date and time

4.3. Using the AC power adapter

4.4. Connecting the cuff and monitor

4.5. Select the user

4.6. Select the measuring mode: standard or Microlife Averaging Mode

4.7. Microlife Averaging Mode

5. How do take a measurement?

5.1. Preparing to take a measurement

5.2. Common errors

5.3. Using the cuff

5.4. Taking a measurement

5.5. Memory: Reviewing readings

5.6. Stopping a measurement

5.7. Hypertension risk indicator

5.8. Irregular heartbeat detector

5.9. Battery change indicator

6. Software

6.1. Installation and data transmission

7. Error messages/troubleshooting

8. Care and maintenance

9. Limited warranty

10. Technical specifications

11. How to contact us

1. ntroduction

1.1. 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.

1.2. Gentle+ Measurement System

Gentle+, our most advanced system to date, combines clinical accuracy

and premium features including:

• A quieter, more comfortable measurement experience that reduces the

amount of time your arm is under pressure. Less pressure = more comfort!

• An ergonomic cuff design that is easier to use and fits a wider range of

arm sizes (for arms 8.7”-16.5”).

2. How is blood pressure measured?

2.1. 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 (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.

--Blood pressure is too high if your systolic blood pressure is over 160

mmHg and/or your diastolic pressure is above 100 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.

2.2. Measurement Guidelines

The following standards for assessing high blood pressure (in adults) have

been established by the National Institutes of Health JNC7, 2003.

Additional information

• 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.

• Correctly measured diastolic blood pressure values above 120 mmHg

require immediate medical treatment.

2.3. What can do to change my blood pressure?

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 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.

Category Systolic Diastolic

(mmHg) (mmHg)

Normal <120 and <80

Pre-Hypertension 120-139 or 80-89

Hypertension

Stage 1 Hypertension 140-159 or 90-99

Stage 2 Hypertension ≥160 or ≥100

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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