Microlife BP A3L PC Bedienungsanleitung

Microlife BP A3L PC (BP3GX1-3BPBX)

○1 ON/OFF button

○2 Display

○3 Cuff Socket

○4 Battery Compartment

○5 Mains Adapter Socket

○6 Cuff

○7 Cuff Connector

○8 MAM Switch

○9 M-button (memory)

○10 Time Button

○11 User Indicator

○12 Battery Display

○13 Date/Time

○14 Systolic Value

○15 Diastolic Value

○16 Pulse Rate

○17 Traffic Light Indicator

○18 Pulse Indicator

○19 Cuff Pressure Check

○20 MAM Mode

○21 Irregular Heartbeat Detection (IHB)

○22 Arm Movement Indicator

○23 Bluetooth

○24 Stored Value

Type BF applied part

Keep dry

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.

Intended use:

This oscillometric blood pressure monitor is intended for measuring non-invasive blood

pressure in people aged 12 years or older.

The device can be used in connection with a smart phone via Bluetooth. The measurement

data can be transferred to a smart phone running the Microlife Connected Health+ mobile

software (App).

Dear Customer,

This device was developed in collaboration with physicians and clinical tests carried out prove

its measurement accuracy to be of a very high standard.*

If you have any questions, problems or want to order spare parts please contact your local

Microlife-Customer Service. Your dealer or pharmacy will be able to give you the address of the

Microlife dealer in your country. Alternatively, visit the internet at www.microlife.com where you

will find a wealth of invaluable information on our products.

Stay healthy –Microlife AG!

* This device is tested according to the ESH protocol and ISO81060-2:2013.

Warning

Indicates a potentially hazardous situation, which if not avoided, could result in death or serious

injury.

⚫This device may only be used for the purposes described in these instructions. The

manufacturer cannot be held liable for damage caused by incorrect application.

⚫Protect the device & accessories from the following to avoid damaging the device:

- Water, other liquids, and moisture

- Extreme temperatures

- Impacts and vibrations

- Direct sunlight

- Contamination and dust

⚫DO NOT change the patient medication and treatment based the result of one or multiple

measurements. Treatment and medication changes should be prescribed only by a

medical professional.

⚫Inspect the device, cuff, and other parts for damage. DO NOT use the device, cuff or

parts if they appear damaged or operating abnormally.

⚫Observing the operation of the device and arm to make sure no prolonged impairment of

the circulation of the blood.

⚫DO NOT dissemble or attempt to service the device, accessory and parts, during use or

in storage. Access to the device internal hardware and software is prohibited.

Unauthorized access and servicing of the device, during use or in storage, may

compromise the safety and performance of the device.

⚫Ensure that children do not use this device unsupervised; some parts are small

enough to be swallowed. Be aware of the risk of strangulation in case this device is

supplied with cables or tubes.

⚫Blood flow of the arm is temporarily reduced during measurement. Extended interruption

of blood flow reduces peripheral circulation and in extreme cases may result in juries.

Beware of signs (for example tissue discoloration) of impeded peripheral circulation if

taking measurements continuously or for an extended period of time (for example more

than 30 minutes).

⚫DO NOT use this device in oxygen rich environment or near flammable gas.

⚫The device is not water resistant or water proof. DO NOT spill or immerse the device in

water or other liquids.

⚫The atrial fibrillation (AF) screening function of this device is not meant to diagnose atrial

fibrillation. Diagnosis of atrial fibrillation must be made by a cardiologist based on

interpretation of electrocardiograms (ECG). DO NOT make medical decisions based

solely on the results

⚫This device is reusable. It is recommended to clean and disinfect the device and the

accessory prior to use if contamination or cross contamination are possible.

⚫Always use the arm cuff of range appropriate for the mid arm circumference of the

patient.

⚫Stop using this device and cuff and consult with your doctor if you experience skin

irritation or discomfort.

⚫DO NOT use this device, cuff or parts after the expiration of its stated service life.

Precaution

Indicates a potentially hazardous situation which, if not avoided, may result in minor or

moderate injury to the user or patient, or cause damage to the device or other property.

⚫The device is intended only for measuring blood pressure at upper arm. DO NOT

measure other sites because the reading does not reflect your blood pressure accurately.

⚫Presence of significant cardiac arrhythmia during measurement may interfere with blood

pressure measurement and affect the reliability of blood pressure readings. Consult with

your doctor about whether the device is suitable for use in this case.

⚫Consult with doctor before the application of the CUFF over a wound, as this can cause

further injury.

⚫Consult with doctor before the application of the CUFF and its pressurization on an arm

where intravascular access or therapy, or an arterio-venous (A-V) shunt is present

because of temporary interference with blood flow and could result in injury.

⚫Consult with doctor before the application of the CUFF and its pressurization on the arm

on the side of a mastectomy or lymph node clearance

⚫DO NOT use this device with other medical electrical (ME) equipment simultaneously.

This may cause device malfunction or measurement inaccuracies.

⚫Do not use this device close to strong electromagnetic fields such as mobile telephones

or radio installations. Keep a minimum distance of 3.3 m from such devices when using

this device.

⚫This device is not intended for use in ambulatory environments.

⚫This device is not intended for use on aircraft.

⚫The cuffs are sensitive and must be handled with care.

⚫Avoid kinking, pressing, and moving of the cuff tube during device operation, as this

affects reading reliability and may cause injury if the device deflation is interrupted.

⚫Use this device only with compatible accessories from Microlife, including cuffs,

connectors, and adaptors. Using non-compatible accessories may compromise the safety

and performance of the device.

⚫Only pump up the cuff once fitted

⚫Use and store the device, cuff and parts in temperature and humidity conditions specified

in the Technical Description. Usage and storage of the device, cuff and parts in conditions

outside ranges given in the Technical Description may results in device malfunction and

the safety of usage.

⚫Read the additional safety information provided within the individual sections of this

instruction manual.

FCC

Any Changes or modifications not expressly approved by the party responsible for compliance

could void the user's authority to operate the equipment.

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.

Note: This equipment has been tested and found 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 installed and 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 off and 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.

-Connect the equipment into an outlet on a circuit different from that to which the receiver is

connected.

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

This transmitter must not be co-located or operating in conjunction with any other antenna or

transmitter.

The device has been evaluated to meet general RF exposure requirement. The device can be

used in portable exposure condition without restriction.

Important Information about Blood Pressure

⚫The measurement results given by this device is not a diagnosis. It is not replacing the

need for the consultation of a physician, especially if not matching the patients symptoms.

Do not rely on the measurement result only, always consider other potentially occurring

symptoms and the patient's feedback. Calling a doctor or an ambulance is advised if

needed.

⚫Permanently high blood pressure values can damage your health and must be

treated by your doctor!

⚫Always discuss your values with your doctor and tell him/her if you have noticed

anything unusual or feel unsure. Never rely on single blood pressure readings.

⚫Deviations between measurements taken by your doctor or in the pharmacy and those

taken at home are quite normal, as these situations are completely different.

⚫The pulse display is not suitable for checking the frequency of heart pacemakers!

⚫Take blood pressure measurements more often than necessary frequency is not advised

and may cause injury to the PATIENT due to blood flow interference

⚫If you are pregnant, you should monitor your blood pressure regularly as it can change

drastically during this time.

Table of Contents

1. Using the Device for the First Time

•Inserting the batteries

•Setting the date and time

•Selecting the correct cuff

•Selecting the user

•Selecting standard or MAM mode

2. Checklist for Taking a Reliable Measurement

3. Taking a Blood Pressure Measurement

•How not to store a reading

•How do I evaluate my blood pressure?

•Irregular Heartbeat Detection (IHB)

4. Data Memory

•Viewing the stored values

•Clearing all values

5. Battery Indicator and Battery change

•Low battery

•Flat battery –replacement

•Which batteries b and which procedure?

•Using rechargeable batteries

6. Using a Mains Adapter

7. Bluetooth® Function

•Bluetooth® Operations

•Bluetooth® pairing & app setup

•Bluetooth® Status

8. Error Messages

9. Maintenance, Service, and Disposal

•Maintenance

•Cleaning

•Service & Calibration

•Disposal

10. Guarantee

11.Technical Specifications

1. Using the Device for the First Time

Inserting the batteries

After you have unpacked your device, first insert the batteries. The battery compartment ○4 is

on the bottom of the device. Insert the batteries (4 x 1.5 V, size AA), thereby observing the

indicated polarity.

Setting the date and time

1. After the new batteries are fitted, the year number ○13flashes in the display, You can set

year by pressing the M-button ○9 , press the Time button ○10 to confirm, Then set the month,

press the Time button○10.

2. Then, press the M-button○9 to set the month. Press the Time button○10 to confirm. Follow

the instructions above to set the day, hour and minutes.

4. Once you have set the minutes and pressed the Time button○10 , the date and time are set

and the time is displayed.

5. If you want to change the date and time, press, and hold the Time button ○10 until the User

Indicator ○11and Diastolic Value○15 start to flash. Release the button when the User Indicator

○11 stop flashing but only Diastolic Value ○15 still flash, and then you can enter the new values

of date and time as described above.

Selecting the correct cuff

Only use Microlife cuffs.

Contact your local Microlife Service if the enclosed cuff ○6 does not fit.

Tube connection

Push the cuff connector○7 into the cuff socket○3 as far as it will go.

Note: Please make sure the plug is totally inserted into cuff socket (see

picture). A loose connection will result in inaccurate readings and "Err 3 ".

Selecting the user

The device allows to store the results for individual users.

Select the intended user (user 1 or user 2 ○11) by pressing and hold the Time button ○10 for

approx. 3 seconds until the User Indicator ○11 start to flash. Then, press the M-button○9

to set the intended user. Press the Time button○10 to confirm.

Before each measurement, ensure the correct user is selected.

Selecting standard or MAM mode

Before each measurement, select standard (single measurement) or MAM mode (automatic

double measurement). In MAM mode, 3 measurements are automatically taken in succession

and the result is then automatically analyzed and displayed. Because the blood pressure

constantly fluctuates, a result obtained in this way is more reliable than when a single

measurement is performed.

To select standard mode, slide the MAM switch ○8 on the side of the device downwards to

position «1» and to select MAM mode, slide this switch upwards to position «3».

MAM mode (highly recommended)

•In MAM mode, 3 measurements are automatically taken in succession and the result is then

automatically analyzed and displayed. Because the blood pressure constantly fluctuates, a

result determined in this way is more reliable than one produced by a single measurement.

•When you select the 3 measurements, the MAM-symbol ○20 appears in the display.

•The bottom, right hand section of the display shows a 1, 2 or 3 to indicate which of the 3

measurements is currently being taken.

•There is a break of 15 seconds between the measurements. A count down indicates the

remaining time.

•The individual results are not displayed. Your blood pressure will only be displayed after all 3

measurements are taken.

•Do not remove the cuff between measurements.

•If one of the individual measurements was questionable, a fourth one is automatically taken.

2. Checklist for Taking a Reliable Measurement

Avoid activity, eating or smoking immediately before the measurement.

Sit down on a back-supported chair and relax for 5 minutes. Keep the feet flat on the floor

and do not cross your legs.

Always measure on the same arm (normally left). It is recommended that doctors

perform double arm measurements on a patient’s first visit in order to determine which

arm to measure in the future. The arm with the higher blood pressure should be

measured.

Remove close-fitting garments from the upper arm. To avoid constriction, shirt sleeves

should not be rolled up - they do not interfere with the cuff if they are laid flat.

Always ensure that the correct cuff size is used (marking on the cuff).

Fit the cuff closely, but not too tight.

Make sure that the cuff is positioned 2 cm above the elbow.

The artery mark on the cuff (ca. 3 cm long bar) must lie over the artery which runs

down the inner side of the arm.

Support your arm so it is relaxed.

Ensure that the cuff is at the same height as your heart.

3. Taking a Blood Pressure Measurement

1. Select standard (single measurement) or MAM mode (automatic double measurement): see

details in chapter «1.».

2. Press the ON/OFF button○1 to start the measurement.

3. The cuff will now pump up automatically. Relax, do not move and do not tense your arm

muscles until the measurement result is displayed. Breathe normally and do not talk.

4. The measurement is performed during the inflation. The inflation speed may vary, this is a

normal occurrence.

5. During the measurement, the pulse indicator ○18 flashes in the display.

7. The result, comprising the systolic○14 and the diastolic ○15 blood pressure and the pulse

rate ○16 is displayed. Note also the explanations on further display symbols in this booklet.

8. When the device has finished measuring, remove the cuff.

9. Switch off the device. (The monitor does switch off automatically after approx. 1 min.).

You can stop the measurement at any time by pressing the ON/OFF button ○1 (e.g. if

you feel uneasy or an unpleasant pressure sensation).

How not to store a reading

As soon as the reading is displayed press and hold the ON/OFF button ○1 until «M» Stored

Value ○24 is flashing. Confirm to delete the reading by pressing the Time button ○10. «CL» is

displayed when the reading is deleted from the memory successfully.

How do I evaluate my blood pressure?

The triangle on the left-hand edge of the display○17 points at the range within which the

measured blood pressure value lies. The value is either within the normal (green), borderline

(yellow), danger (orange, red) range. The classification corresponds to the following ranges

defined by ACC, AHA 2017 Guidelines. Data in mmHg.

Range

Systolic

Diastolic

Recommendation

blood pressure too high

≧130

≧80

Seek medical advice

blood pressure elevated

120 -130

and

＜80

Self-check

blood pressure optimum

＜120

and

＜80

Self-check

The higher value is the one that determines the evaluation.

Example: a blood pressure value of 140/80 mmHg or a value of 130/90 mmHg indicates

«blood pressure too high».

Appearance of Irregular Heartbeat Detection (IHD)

This symbol ○21 indicates that certain pulse irregularities were detected during the

measurement. In this case, the result may deviate from your normal blood pressure –repeat

the measurement.

In most cases, this is no cause for concern. However, if the symbol appears on a regular basis

(e.g. several times a week with measurements taken daily) we advise you to tell your doctor.

Please show your doctor the following explanation:

Information for the doctor on frequent appearance of the Irregular Heartbeat Detection (IHD)

This device is an oscillometric blood pressure monitor that also analyses pulse irregularity

during measurement. The device is clinically tested.

The Irregular Heartbeat Detection (IHD) symbol is displayed after the measurement, if pulse

irregularities occur during measurement. If the symbol appears more frequently (e.g. several

times per week on measurements performed daily) we recommend the patient to seek medical

advice.

This device does not replace a cardiac examination but serves to detect pulse irregularities at

an early stage.

4. Data Memory

This device automatically stores up to 99 measurement values for each of the 2 users.

Viewing the stored values

Press the M-button ○9 briefly, when the device is switched off. The display first shows «M»

○24 and «A», which stands for the average of all stored values.

Pressing the M-button ○9 again displays the previous value. Pressing the M-button ○9

repeatedly enables you to move from one stored value to another.

Pay attention that the maximum memory capacity of 99 memories per user is not

exceeded. When the 99 memory is full, the oldest value is automatically overwritten with

the 100th value. Values should be evaluated by a doctor before the memory capacity is

reached –otherwise data will be lost.

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