Microlife BP3GY1-2N Bedienungsanleitung

Premium

Blood

Pressure

Monitor

INSTRUCTION MANUAL

QUE S TION S ? 1 -8 0 0 -5 6 8 -4 1 4 7

Model # BP3 GY1 -2 N

Important Product and Safety Information

Follow Instructions for Use. This document provides

importantproductoperationandsafetyinformationregarding

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 athome or in the doctor’s

office.Itenablesaveryfastandreliablemeasurement ofthe systolicand

diastolic blood pressure, as well as the pulse rate, by way of the oscillo-

metric method during cuff inflation. This device detects the appearance of

irregularheartbeatsduringmeasurement andprovides awarning signal

when the irregular heartbeat is detected. The device can be connected via

Bluetooth to a smart mobile device running the App.

This blood pressure monitor IS intended to be used:

•

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

whereasthepersonbeing measuredmay be theuser/operator ofthe

device.

•

Within a home healthcare environment.

•

Withacufflocated upontheuser’supperarm;½inchabovethe elbow

over the artery as indicated on the cuff.

This blood pressure monitor IS NOT intended for use with:

•

Pregnancy

•

Preeclampsia

•

Children under12

•

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

valuesmustalwaysbe discussedwithyourdoctor. Undernocircum-

stancesshouldyouindependentlyalterthedosagesofanydrugs

prescribed by your physician.

•

Consultyourphysicianbefore usingthisdeviceif any of thefollowingor

similarconditionsarepresent:arrhythmiassuchasatrialor ventricular

prematurebeatsoratrialfibrillation,arterialsclerosis,poorperfusion,

diabetes, age, pregnancy, preeclampsia, renal diseases. Motion during

measurement, including trembling or shivering may affect the measurement.

•

Thoughnotfor usewithchildrenunder12,ensurethatanychildren

aroundthisdevicearesupervised;somepartsaresmallenoughtobe

swallowedandanypresenttubesorcablesmayprovideariskof

strangulation.

•

Ensurethe cuff tubing is notkinkedduringuseas harmful injury may

occurduetothe effectofbloodflow interferencecaused by highpressure

in the cuff not releasing.

DO NOT:



Use thisdeviceifyouthinkitisdamagedor anythingappearsunusual

(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 Cuffover alimbnear theside ofamastectomy

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.



MaintainpressureintheCuffappliedtothelimbforaprolongedamount

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 orwhen power is supplied. When

thedeviceisnot inuse andpoweris removed,cuffassembly,batteries

andacadapter (if applicable)may be replacedby theuserwithMicrolife

suppliedreplacements.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

•

Thisdevice contains sensitive electronics components. Avoidstrong

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,removethebatteriesto avoidpotentialbattery leakageand

damage to the monitor.

•

Whenreplacingthebatteries,ensureallthebatteriesarereplaced

simultaneously toavoidbattery damageandpotentialdamagetothe

monitor.Microlife USA does not recommend using rechargeable batteries.

•

To avoid inaccurate measurements and to lessen any discomfort from

Cuff pressure, ensurethe Cuff isplaced 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

yourpotentialbloodpressurerisk.However,thisfeatureisneither a

diagnosisnorasubstituteforamedicalexamination.Itisimportantto

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 thirdparty accessories.Only useMicrolifeauthorized accessories,

suchascuffsorACadapters,asthosenotapprovedforusewiththe

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 ofmore

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

Trademark Usage:

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

registeredintheU.S.andothercountries.AppStoreis aservicemark of

Apple Inc.

Android and Google Play are both trademarks of Google Inc.

TheBluetooth®Smartwordmarkandlogosareregisteredtrademarks

owned by Bluetooth SIG, Inc. and any use of such marks in this Blood

Pressure Monitor is under license. Other trademarks and trade names are

those of their respective owners.

Federal Communications Commission (FCC) Statement

15.21

You are cautioned that changes or modifications not expressly approved by

thepartresponsibleforcompliancecouldvoidtheuser’sauthorityto

operate theequipment.

15.105(b)

This equipment hasbeentested andfoundtocomply with the limits for a

ClassB digitaldevice,pursuanttopart15oftheFCCrules.These limitsare

designed to provide reasonable protection against harmful interference in a

residential installation.

This equipment generates uses and can radiate radio frequency energy and,

ifnotinstalledandusedinaccordancewiththeinstructions,maycause

harmful interference to radio communications. However, there is no

guaranteethatinterferencewillnotoccurinaparticularinstallation.Ifthis

equipment does cause harmful interference to radio or television reception,

whichcanbe determinedby turningtheequipment offand on,the user is

encouraged to try to correct the interference by one or more of the

following measures:

-Reorient or relocate the receiving antenna.

-Increase the separation between the equipment and receiver.

-Connecttheequipment intoanoutletonacircuitdifferentfromthatto

which the receiver is connected.

-Consult the dealer or an experienced radio/TV technician for help.

Thisdevicecomplieswithpart15of theFCCRules.Operationissubjectto

the following two

conditions:

this device may not cause interference and

this device must accept any interference, including interference that may

cause undesired operation of the device.

Premium Automatic Blood Pressure Monitor

Instruction Manual

Table of Contents

Introduction

1.1.

Your automatic blood pressure monitor

1.2.

Diabetes validation

Components of your blood pressure monitor

2.1.

Blood pressure monitor

2.2.

Blood pressure cuff

How do I get started?

3.1.

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.

Selectthemeasuringmode: standardor Microlife Averaging Mode

3.8.

Microlife Averaging Mode

3.9.

Connecting the cuff and monitor

3.10.UsingtheACpoweradapter

How do I take ameasurement?

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.

Battery change indicator

Bluetooth functions and application (App)

5.1.

Bluetooth® icon indicator (on monitor)

5.2.

iOS devices

5.3.

Android OS Phones

Error messages/troubleshooting

7. How is blood pressuremeasured?

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. Careand maintenance

9. Limited warranty

10. Technical specifications

11. How to contact us

Introduction

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 validation

Microlife’s commitment to disease-state management has led to our

clinicalvalidationforusewithdiabetes. Thisisaworldwidefirstthat

reinforces our commitment to quality, accuracy and meaningful innovation.

Components of your blood pressure monitor

2.1.

Measuring unit

Cuff Socket

(yellow)

Hypertension

Risk Indicator

Memory

User Switch

Start, Stop,

Enter

Date/Time

AC Adapter Port

MAM mode

switch

Select 1 or 3

Measurements

Power, Screen Lock

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