Microlife BP3MY1-1P 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 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.

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, 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. void 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

loca

tion 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 US 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 compo-

nents 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. void 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 C 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 MI/ NSI/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: ccording 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 pplied Part

Expected ife

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 " " 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 US 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.

Wrist Blood Pressure Monitor

Instruction Manual

Table of contents

1. Introduction

1.1. Features of the Wrist Blood Pressure Monitor

1.2. Important information about self-measurement

2. Important information about 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. Using your blood pressure monitor for the first time

4.1. Installing the batteries

5. Taking a blood pressure measurement

5.1. Before the measurement

5.2. Common sources of error

5.3. Fitting the cuff

5.4. Measuring procedure

5.5. Discontinuing a measurement

5.6. Irregular heartbeat detection

5.7. Memory – recalling the last measurement

6. Battery charge indicator

7. Error messages/troubleshooting

8. Care and maintenance

9. imited Warranty

10. Technical specifications

11. How to contact us

1. Introduction

1.1. Features of the Wrist 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.

Attention!

1.2. Important information about self-measurement

• Self-measurement is a means of monitoring blood pressure. It should

not be confused with 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 instru-

ment should only be evaluated after consultation with your doctor.

Electromagnetic interference:

The device contains sensitive electronic components. void 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.

2. Important information about 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 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). t 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.

2.2. Which values are normal?

Blood pressure is very 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 ves-

sels 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.

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