Microlife BP3GY1-2N Bedienungsanleitung

mportant Product and Safety nformation

Follow nstructions for Use. This document provides

important product operation and safety information regard-

ing 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, including those with Diabetes

mellitus, 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

during cuff inflation. 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 connected via

luetooth®to a smart mobile device running the Microlife Connected

Health App.

This blood pressure monitor S intended to be used:

• For self-measurement/monitoring of blood pressure and pulse in

adults, including those with Diabetes mellitus; 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 ventric-

ular 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 pacemak-

ers 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 mastecto-

my as this may cause harmful injury.



Use the lood 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, batter-

ies 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 impairment of the measuring accuracy. Move the device to

another location if interference is determined.

• When not using the lood 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 lood Pressure Monitor outside of its specified operation temper-

ature 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 F Applied Part

atteries 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 .H.S. ( ritish Hypertension Society) clinical protocol was used to

measure the accuracy of this product. lood pressure units using the

same measurement technology are graded “AA” for systolic/diastolic

accuracy by independent investigators using the HS protocol. This is the

highest grading available for blood pressure monitors. Please see

bhsoc.org for more information. (Uses the same algorithm as .H.S.

graded “AA” model number 3 T0-1)

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 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

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.

Trademark Usage:

Apple, the Apple logo, iPad, and iPhone are trademarks of Apple Inc.,

registered in the U.S. and other countries. App Store is a service mark of

Apple Inc.

Android and Google Play are both trademarks of Google Inc.

The luetooth®word mark and logos are registered trademarks owned

luetooth SIG, Inc. and any use of such marks in this lood Pressure

Monitor is under license. Other trademarks and trade names are those of

their respective owners.

Bluetooth®Automatic Blood Pressure Monitor

Instruction Manual

Table of Contents

1. ntroduction

1.1. Your automatic blood pressure monitor

1.2. Diabetes mellitus validation

2. Components of your blood pressure monitor

2.1. lood pressure monitor

2.2. lood pressure cuff

3. How do get started?

3.1. Protective screen film

3.2. Inserting the batteries

3.3. Power switch / screen lock

3.4. Using the interactive touch screen

3.5. Setting the date and time

3.6. Select the user

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

3.8. Microlife Averaging Mode

3.9. Connecting the cuff and monitor

3.10.Using the AC power adapter

4. How do take a measurement?

4.1. Preparing to take a measurement

4.2. Common errors

4.3. Using the cuff

4.4. Taking a measurement

4.5. Memory: Reviewing readings

4.6. Stopping a measurement

4.7. Hypertension risk indicator

4.8. Irregular heartbeat detector

4.9. attery change indicator

5. Bluetooth® functions & application (app)

5.1. Activating your luetooth®

5.2. Pairing your device

5.3. Unpairing your device

6. Error messages/troubleshooting

7. How is blood pressure measured?

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

7.2. Measurement Guidelines

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

8. Care and maintenance

9. Limited warranty

10. Technical specifications

11. How to contact us

1. ntroduction

1.1. Your Automatic Blood Pressure Monitor

Thank you for purchasing a fully automatic blood pressure monitor. Your

monitor is designed to provide fast and reliable digital readings of your

pulse, and systolic / diastolic blood pressure using the oscillometric

method on your upper arm. It offers clinically proven accuracy and has

been designed to be user friendly.

If you have additional questions regarding blood pressure measurements

please contact Microlife Customer Service at 1-800-568-4147 or contact

your doctor.

1.2. Diabetes mellitus validation

Diabetes, and stiff arteries, can make accurate blood pressure readings a

challenge. Microlife's commitment to health has led to a breakthrough

clinical validation for accurate readings in the presence of diabetes. This

innovation reinforces our commitment to quality, accuracy, and helping

you take control of your health.

Diabetes mellitus (or diabetes) is a chronic, lifelong condition that affects

your body's ability to use the energy found in food. There are three

major types of diabetes: type 1 diabetes, type 2 diabetes, and gestational

diabetes.

Note: this monitor does not measure blood glucose.

2. Components of your blood pressure monitor

2.1. Measuring unit

Cuff Socket

(yellow)

Start, Stop,

Enter

Hypertension

Risk Indicator

User Switch

Memory

MAM mode

switch

Select 1 or 3

Measurements

Power, Screen Lock

AC Adapter Port

Date/Time

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