Microlife BP A200 AFIB User manual

Europe / Middle-East / Africa
Microlife AG Espenstrasse 139 9443 Widnau / Switzerland Tel. +41 / 71 727 70 30 Fax +41 / 71 727 70 39 Email admin@microlife.ch www.microlife.com
Asia
Microlife Corporation. 9F, 431, RuiGang Road, NeiHu Taipei, 11492, Taiwan, R.O.C. Tel. 886 2 8797-1288 Fax.886 2 8797-1283 Email service@microlife.com.tw www.microlife.com
North / Central / South America
Microlife USA, Inc. 1617 Gulf to Bay Blvd., 2nd Floor Ste A Clearwater, FL 33755 / USA Tel. +1 727 442 5353 Fax +1 727 442 5377 Email msa@microlifeusa.com www.microlife.com
Microlife BP A200 AFIB
EN 1 RU 8 BG 16
IB BP A200 AFIB BY-V3 1314
www.microlife.by www.microlife.bg www.microlife.com
Microlife BP A200 AFIB
TIME
MONTH-DAY
Microlife BP A200 AFIB
1
ON/OFF button
2
M-button (memory)
3
Display
4
Cuff Socket
5
Time Button
6
Cuff
7
Cuff Connector
8
Mains Adapter Socket
9
USB Port
AT
Battery Compartment
AK
MAM Switch
Display
AL
Date/Time
AM
Systolic Value
AN
Diastolic Value
AO
Pulse Rate
AP
Atrial Fibrillation Indicator (AFIB)
AQ
MAM Interval Time
AR
Battery Display
AS
Stored Value
BT
Pulse
BK
MAM Mode
Read the instructions carefully before using this device.
Type BF applied part
EN
Dear Customer, Your new Microlife blood pressure monitor is a reliable medical device for taking measurements on the upper arm. It is simple to use, accurate and comes highly recommended for blood pressure monitoring in your home. This device was developed in collabora­tion with physicians and clinical tests carried out prove its measurement accuracy to be of a very high standard.* Microlife AFIB detection is the world’s leading digital blood pres­sure measurement technology for the early detection of atrial fibril­lation (AFIB) and hypertension. These are the two top risk factors of heart disease and stroke which increase the risk of getting a stroke or heart disease in the future. It is important to detect AFIB and hypertension at an early stage, even though you may not experience any symptoms. Appropriate treatment can reduce your risk of suffering a stroke. For this reason, it is recommended that you visit your doctor when the device gives an AFIB signal during your blood pressure measurement. The AFIB algorithm of Microlife has been clinically investigated by several prominent clinical inves­tigators and showed that the device detects patients with AFIB at 97-100% certainty. Please read through these instructions carefully so that you under­stand all functions and safety information. We want you to be happy with your Microlife product. If you have any questions, problems or want to order spare parts please contact your local Microlife­Customer 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 uses the same measuring technology as the award winning «BP 3BTO-A» model tested according to the British Hypertension Society (BHS) protocol.
1
Stergiou GS, Karpettas N, Protogerou A, Nasothimiou EG, & Kyriakidis M. Diagnostic accuracy of a home blood pressure monitor to detect atrial fibrillation. J Hum Hyperten 2009; 1-5.
2
Wiesel J, Fitzig L, Herschman Y, & Messineo FC Detection of Atrial Fibrillation Using a Modified Microlife Blood Pressure Monitor. Am J Hypertens 2009; 848-852.
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EN
1BP A200 Afib
Table of Contents

1. Important Facts about Blood Pressure and Self-Measurement

• How do I evaluate my blood pressure?
2. Important Facts about Atrial Fibrillation (AFIB)
• What is Atrial Fibrillation (AFIB)?
• How does AFIB impact my family or me?
• Microlife AFIB detection provides a convenient way to screen for AFIB (only in MAM mode)
• Risk factors you can control
3. Using the Device for the First Time
• Activating the fitted batteries
• Setting the date and time
• Selecting the correct cuff
• Select the measuring mode: standard or MAM mode
• MAM mode
4. Taking a Blood Pressure Measurement using this Device
• How not to store a reading
5. Appearance of the Atrial Fibrillation Indicator for early Detection (only in MAM mode)
6. PC-Link Functions
• Installation and data transmission
7. Data Memory
• Viewing the stored values
• Memory full
• Clearing all values
8. Battery Indicator and Battery change
• Low battery
• Flat battery – replacement
• Which batteries and which procedure?
• Using rechargeable batteries
9. Using a Mains Adapter
10. Error Messages
11. Safety, Care, Accuracy Test and Disposal
• Safety and protection
•Device care
• Cleaning the cuff
• Accuracy test
•Disposal
12. Guarantee
13. Technical Specifications
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1. Important Facts about Blood Pressure and Self­Measurement
Blood pressure is the pressure of the blood flowing in the
arteries generated by the pumping of the heart. Two values, the systolic (upper) value and the diastolic (lower) value, are always measured.
The device indicates the pulse rate (the number of times the
heart beats in a minute).
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.
Enter your readings in the enclosed blood pressure diary.
This will give your doctor a quick overview.
There are many causes of excessively high blood pressure
values. Your doctor will explain them in more detail and offer
treatment where appropriate. Besides medication, relaxation techniques, weight loss and exercise can also lower your blood pressure.
Under no circumstances should you alter the dosages of
any drugs prescribed by your doctor!
Depending on physical exertion and condition, blood pressure is subject to wide fluctuations as the day progresses.
therefore take your measurements in the same quiet condi­tions and when you feel relaxed!
ments per day, one in the morning and one in the evening.
It is quite normal for two measurements taken in quick succes-
sion to produce significantly different results.
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.
Several measurements provide a much clearer picture than
just one single measurement.
Leave a small break of at least 15 seconds between two
measurements.
If you are pregnant, you should monitor your blood pressure
very closely as it can change drastically during this time!
If you suffer from an irregular heartbeat, measurements taken
with this device should only be evaluated after consultation with your doctor.
The pulse display is not suitable for checking the
frequency of heart pacemakers!
Take at least two measure-
You should

How do I evaluate my blood pressure?

Table for classifying blood pressure values in adults in accordance with the World Health Organisation (WHO) in 2003. Data in mmHg.
Range Systolic Diastolic Recommendation
blood pressure too low 100 
1. blood pressure optimum
2. blood pressure normal
3. blood pressure slightly high
4. blood pressure too high
5. blood pressure far too high
6. blood pressure dangerously high
100 - 120 60 - 80
120 - 130 80 - 85 130 - 140 85 - 90
140 - 160 90 - 100
160 - 180 100 - 110
180 110 Urgently seek
60
Consult your doctor
Self-check
Self-check Consult your
doctor Seek medical
advice Seek medical
advice
medical advice!
The higher value is the one that determines the evaluation. Example: a readout value between 150/85 or 120/98 mmHg indi­cates «blood pressure too high».

2. Important Facts about Atrial Fibrillation (AFIB)

What is Atrial Fibrillation (AFIB)?

Normally, your heart contracts and relaxes to a regular beat. Certain cells in your heart produce electrical signals that cause the heart to contract and pump blood. Atrial fibrillation occurs when rapid, disorganized electrical signals are present in the heart’s two upper chambers, called the atria; causing them to contract quickly fast and irregularly (this is called fibrillation). Atrial fibrillation is the most common form of heart arrhythmia or irregular heart beat. You can live with atrial fibrillation, but it can lead to other rhythm prob­lems, chronic fatigue, heart failure and - worst of all - a stroke. You’ll need a doctor to help you control the problem.

How does AFIB impact my family or me?

One in every six strokes is AFIB-related. Whilst individuals above the age of 65 are more likely to have AFIB, individuals as young as 40 can exhibit AFIB. Early diagnosis can help reduce the risk of a stroke.

Microlife AFIB detection provides a convenient way to screen for AFIB (only in MAM mode)

Knowing your blood pressure and knowing whether you or your family members have AFIB can help reduce the risk of stroke.
Microlife AFIB detection provides a convenient way to screen for AFIB whilst taking your blood pressure.

Risk factors you can control

High blood pressure and AFIB are both considered «controllable» risk factors for strokes. Knowing your blood pressure and knowing whether you have AFIB is the first step in proactive stroke prevention.

3. Using the Device for the First Time

Activating the fitted batteries

Pull out the protective strip from the battery compartment AT.

Setting the date and time

1. After the new batteries are fitted, the year number flashes in the
display. You can set the year by pressing the M-button 2. To confirm and then set the month, press the time button 5.
2. Press the M-button to set the month. Press the time button to confirm and then set the day.
3. Follow the instructions above to set the day, hour and minutes.
4. Once you have set the minutes and pressed the time button, 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 down for approx. 3 seconds until the year number starts to flash. Now you can enter the new values as described above.

Selecting the correct cuff

Microlife offers different cuff sizes. Select the cuff size to match the circumference of your upper arms (measured by close fitting in the centre of the upper arm).
Cuff size for circumference of upper arm
S 17 - 22 cm (6.75 - 8.75 inches) M 22 - 32 cm (8.75 - 12.5 inches) L 32 - 42 cm (12.5 - 16.5 inches) M - L 22 - 42 cm (8.75 - 16.5 inches)
This device comes with a preformed M-L size cuff «Easy».
Only use Microlife cuffs.
Contact your local Microlife Service if the enclosed cuff 6 does not fit.
Connect the cuff to the device by inserting the cuff connector 7 into the cuff socket 4 as far as it will go.

Select the measuring mode: standard or MAM mode

This device enables you to select either standard (standard single measurement) or MAM mode (automatic triple measurement). To
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3BP A200 Afib
select standard mode, slide the MAM switch AK on the side of the device downwards to position «1» and to select MAM mode, slide this switch upwards to position «3».

MAM mode

In MAM mode, 3 measurements are automatically taken in succes­sion and the result is then automatically analysed and displayed. Because blood pressure constantly fluctuates, a result determined in this way is more reliable than one produced by a single measurement. AFIB detection is only activated in MAM mode.
After pressing the ON/OFF button 1, the MAM-symbol BK
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 (15 seconds are adequate according to «Blood Pressure Moni­toring, 2001, 6:145-147» for oscillometric instruments). 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.
4. Taking a Blood Pressure Measurement using this
Device
Checklist for taking a reliable measurement
1. Avoid activity, eating or smoking immediately before the measurement.
2. Sit down for at least 5 minutes before the measurement and relax.
3. Always measure on the same arm (normally left).
4. 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.
5. 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 located 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.
6. Press the ON/OFF button 1 to start the measurement.
7. 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.
8. When the correct pressure is reached, the pumping stops and the pressure falls gradually. If the required pressure was not reached, the device will automatically pump some more air into the cuff.
9. During the measurement, the heart symbol BT flashes in the display every time a heartbeat is detected.
10.The result, comprising the systolic AM and the diastolic AN blood pressure and the pulse rate AO is displayed. Note also the explanations on further display symbols in this booklet.
11.When the device has finished measuring, remove the cuff.
12.Enter the result in the enclosed blood pressure pass and switch off the device. (The monitor does switch off automatically after approx. 1 min.).

How not to store a reading

As soon as the reading is displayed press and hold the ON/OFF button 1 until «AS is flashing. Confirm to delete the reading by pressing the M-button 2.
You can stop the measurement at any time by pressing the
ON/OFF button (e.g. if you feel uneasy or an unpleasant pressure sensation).
5. Appearance of the Atrial Fibrillation Indicator for
early Detection (only in MAM mode)
This symbol AP indicates that an atrial fibrillation was detected during the measurement. This device is able to detect atrial fibrilla­tion (AFIB). If AFIB is present during blood pressure measurement, the AFIB Indicator is displayed. In this case, the result may deviate from your normal blood pressure. It is highly recommended to take an additional measurement an hour later to increase the specificity of the detection. 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 visit your doctor. Please, provide the following explanation:
4
Information for the doctor on frequent appearance of the atrial fibrillation indicator
This device is an oscillometric blood pressure monitor that also analyses pulse frequency during measurement. The device is clinically tested. The AFIB symbol is displayed after the measurement, if atrial fibril­lation 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. The device does not replace a cardiac examination, but serves to detect atrial fibrillations at an early stage.
Sometimes the device will detect atrial fibrillation even when
it is not there. This can happen if the arm moves during the reading or another rhythm problem is present. Keep the arm still during the reading. Visiting your doctor with this device may be necessary to check out any rhythm problems. This device may not detect atrial fibrillation in people with
pacemakers or defibrillators.

6. PC-Link Functions

This device can be used in conjunction with a personal computer (PC) running the Microlife Blood Pressure Analyser (BPA) software. The memory data can be transferred to the PC by connecting the monitor via a cable. If no CD and cable is included download the BPA software from www.microlife.com and use a USB cable with a Mini-B 5 pin connector.

Installation and data transmission

1. Insert CD into the CD ROM drive of your PC. The installation will start automatically. If not, please click on «SETUP.EXE».
2. Connect the monitor via the cable to the PC; there is no need to switch the device on. 3 horizontal bars will appear on the display and last for 3 seconds.
3. The bars will then flash to indicate that the connection between PC and device is successful. As long as the cable is plugged in, the bars will keep flashing and the buttons are disabled.
During the connection, the device is completely controlled
by the computer. Please refer to the «help» file for software instructions.

7. Data Memory

At the end of each measurement, this device automatically stores the result, including date and time.

Viewing the stored values

Press the M-button 2 briefly, when the device is switched off. The display first shows «AS and then a value, e.g. «M 17». This means that there are 17 values in the memory. The device then switches to the last stored result. Pressing the M-button again displays the previous value. Pressing the M-button repeatedly enables you to move from one stored value to another.

Memory full

Pay attention that the maximum memory capacity of 200 is
not exceeded. When the memory is full, the old values are automatically overwritten with new ones. Values
should be evaluated by a doctor before the memory capacity is reached – otherwise data will be lost.

Clearing all values

If you are sure that you want to permanently remove all stored values, hold down the M-button (the device must have been switched off beforehand) until «CL» appears and then release the button. To permanently clear the memory, press the M-button while «CL» is flashing. Individual values cannot be cleared.

8. Battery Indicator and Battery change

Low battery

When the batteries are approximately ¾ empty the battery symbol AR will flash as soon as the device is switched on (partly filled battery displayed). Although the device wi ll continue to measure reliably, you should obtain replacement batteries.

Flat battery – replacement

When the batteries are flat, the battery symbol AR will flash as soon as the device is switched on (flat battery displayed). You cannot take any further measurements and must replace the batteries.
1. Open the battery compartment AT at the back of the device.
2. Replace the batteries – ensure correct polarity as shown by the symbols in the compartment.
3. To set date and time, follow the procedure described in «Section 3.».
The memory retains all values although date and time must
be reset – the year number therefore flashes automatically after the batteries are replaced.
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5BP A200 Afib

Which batteries and which procedure?

Use 4 new, long-life 1.5 V, size AA batteries.
Do not use batteries beyond their date of expiry.
Remove batteries if the device is not going to be used for a
prolonged period.

Using rechargeable batteries

You can also operate this device using rechargeable batteries.
Only use «NiMH» type reusable batteries.
Batteries must be removed and recharged when the flat
battery symbol appears. They should not remain inside the device as they may become damaged (total discharge as a result of low use of the device, even when switched off). Always remove the rechargeable batteries if you do not
intend to use the device for a week or more. Batteries cannot be charged in the blood pressure monitor.
Recharge batteries in an external charger and observe the information regarding charging, care and durability.

9. Using a Mains Adapter

You can operate this device using the Microlife mains adapter (DC 6V, 600 mA).
Only use the Microlife mains adapter available as an original
accessory appropriate for your supply voltage, e.g. the «Microlife 230V adapter». Ensure that neither the mains adapter nor the cable are
damaged.
1. Plug the adapter cable into the mains adapter socket 8 in the
blood pressure monitor.
2. Plug the adapter plug into the wall socket. When the mains adapter is connected, no battery current is consumed.

10. Error Messages

If an error occurs during the measurement, the measurement is interrupted and an error message, e.g. «ERR 3», is displayed.
Error Description Potential cause and remedy
«
ERR 1
» Signal too
weak
The pulse signals on the cuff are too weak. Re-position the cuff and repeat the measurement.*
Error Description Potential cause and remedy
«
ERR 2
» Error signal During the measurement, error signals
ERR 3
» No pres-
«
«
«
«
«
* Please consult your doctor, if this or any other problem occurs repeatedly.
sure in the cuff
ERR 5
» Abnormal
result
ERR 6
» MAM Mode There were too many errors during the
HI
» Pulse or cuff
pressure too high
LO
» Pulse too
low
If you think the results are unusual, please read through the information in «Section 1.» carefully.
were detected by the cuff, caused for instance by movement or mu scle tension. Repeat the measurement, keeping your arm still.
An adequate pressure cannot be gener­ated in the cuff. A leak may have occurred. Check that the cuff is correctly connected and is not too loose. Replace the batteries if necessary. Repeat the measurement.
The measuring signals are inaccurate and no result can therefore be displayed. Read through the checklist for performing reliable measurements and then repeat the measurement.*
measurement in MAM mode, making it impossible to obtain a final result. Read through the checklist for performing reli­able measurements and then repeat the measurement.*
The pressure in the cuff is too high (over 300 mmHg) OR the pulse is too high (over 200 beats per minute). Relax for 5 minutes and repeat the measurement.*
The pulse is too low (less than 40 beats per minute). Repeat the measurement.*

11. Safety, Care, Accuracy Test and Disposal

Safety and protection
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.
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