Microlife BPB3 AFIB User Manual

Microlife BP B3 AFIBBefore each measurement / Przed każdym pomiarem
Preparation / Przygotowanie
1.
2.
3.
Avoid eating, bathing, smoking or caffeine (approx. 30 min).
Unikaj jedzenia, kąpieli, palenia lub kofeiny (około 30 minut).
Avoid activity and relax for 5-10 min.
Unikaj aktywności i zrelaksuj się przez 5-10 minut.
Measure before medication intake.
Zmierz przed przyjęciem leku.
BP
B3 AFIB
Ciśnieniomierz automatyczny
1
1.
2.
3.
4.
5.
Sit on a back-supported chair and keep your legs uncrossed.
Usiądź na krześle wspieranym plecami i nie rozstawiaj nóg.
Avoid thick or close-fitting garments on the upper arm.
Unikaj grubej lub dopasowanej odzieży na ramieniu.
Place the artery-mark on the cuff over your artery.
Umieść mankiecie na tętnicy.
Fit the cuff closely, but not too tight.
Zaciśnij mankiet dokładnie, jednak niezbyt silnie.
Position the cuff 2-3 cm above your elbow.
Ustaw mankiet na 2-3 cm powyżej łokcia.
Microlife AG Espenstrasse 139 9443 Widnau / Switzerland www.microlife.com
IB BP B3 AFIB EN-PL 2518
PL
9
6.
Keep your arm still and do not speak during the measurement.
Trzymaj rękę nieruchomo i nie mów podczas pomiaru.
Microlife BP B3 AFIB
1
ON/OFF button
2
Display
3
M-button (memory)
4
MAM button
5
Cuff Socket
6
Mains Adapter Socket
7
Battery Compartment
8
Cuff
9
Cuff Connector
AT
Cuff Tube
Display
AK
Date/Time
AL
Systolic Value
AM
Diastolic Value
AN
Pulse Rate
AO
MAM Mode
AP
Stored Value
AQ
Battery Display
AR
Cuff Fit Check
-A: Suboptimal Cuff Fit
-B: Arm Movement Indicator «Err 2»
-C: Cuff Pressure Check «Err 3»
AS
Cuff Signal Indicator «Err 1»
BT
Pulse Arrhythmia Indicator (PAD)
BK
Atrial Fibrillation Indicator (AFIB)
BL
Traffic Light Indicator
BM
Pulse Indicator
Read the instructions carefully before using this device.
Type BF applied part
Keep dry
1
EN
Intended use: This oscillometric blood pressure monitor is intended for measuring non-invasive blood pressure in people aged 12 years or older. It is clinically validated in patients with hypertension, hypotension, diabetes, pregnancy, pre-eclampsia, atherosclerosis, end-stage renal disease, obesity and the elderly. The device can detect an irregular pulse suggestive of Atrial Fibril­lation (AF). Please note that the device is not intended to diagnose AF. A diagnosis of AF can only be confirmed by ECG. The patient is advised to see a physician.
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.* Microlife AFIBsens is the world’s leading digital blood pressure measurement technology for the detection of atrial fibrillation (AF) and arterial hypertension. These are the two top risk factors of getting a stroke or heart disease. It is important to detect AF and hypertension at an early stage, even though you may not experi­ence any symptoms. AF screening in general and thus also with the Microlife AFIB algorithm, is recommended for people of 65 years and older. The AFIB algorithm indicates that atrial fibrillation may be present. 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 a
certainty of 97-100%. 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 uses the same measuring technology as the award winning «BP 3BTO-A» model tested according to the British Hypertension Society (BHS) protocol.
1
Kearley K, Selwood M, Van den Bruel A, Thompson M, Mant D, Hobbs FR et al.: Triage tests for identifying atrial fibrillation in primary care: a diagnostic accuracy study comparing single-lead ECG and modified BP monitors. BMJ Open 2014; 4:e004565.
1,2
Name of Purchaser Imię i nazwisko nabywcy
Serial Number Numer seryjny
Date of Purchase Data zakupu
Specialist Dealer Przedstawiciel
Microlife BP B3 AFIBGuarantee CardMicrolife BP B3 AFIB
2
Wiesel J, Arbesfeld B, Schechter D: Comparison of the Microlife blood pressure monitor with the Omron blood pressure monitor for detecting atrial fibrillation. Am J Cardiol 2014; 114:1046-1048.
Table of Contents

1. Appearance of the Atrial Fibrillation Indicator for early Detection (Active only in MAM mode)

• What is Atrial Fibrillation (AF)?
• Who should be screened for Atrial Fibrillation?
• Risk factors you can control
2. Using the Device for the First Time
• Inserting the batteries
• Setting the date and time
• Selecting the correct cuff
• Selecting standard or MAM mode
3. Checklist for Taking a Reliable Measurement
4. Taking a Blood Pressure Measurement
• Manual inflation
• How not to store a reading
• How do I evaluate my blood pressure?
• Appearance of the Pulse Arrhythmia (PAD)
5. Data Memory
• Viewing the stored values
• Clearing all values
6. Battery Indicator and Battery change
• Low battery
• Flat battery – replacement
• Which batteries and which procedure?
• Using rechargeable batteries
7. Using a Mains Adapter
8. Error Messages
9. Safety, Care, Accuracy Test and Disposal
• Safety and protection
• Device care
• Cleaning the cuff
• Accuracy test
•Disposal
10. Guarantee
11. Technical Specifications Guarantee Card (see Back Cover)
1. Appearance of the Atrial Fibrillation Indicator for early Detection (Active only in MAM mode)
This device is able to detect atrial fibrillation (AF). This symbol BK indicates that atrial fibrillation was detected during the measurement. Please refer to the next paragraph for information regarding the consultation with your doctor.
Information for the doctor on frequent appearance of the atrial fibrillation indicator
This device is an oscillometric blood pressure monitor that also analyses pulse irregularity during measurement. The device is clinically tested. The AFIB symbol is displayed after the measurement, if atrial fibrilla­tion occurred during measuring. If the AFIB symbol appears after having performed a full blood pressure measurement episode (tripli­cate measurements), the patient is advised to perform another measurement episode (triplicate measurements). If the AFIB symbol appears again, we recommend the patient to seek medical advice. If the AFIB-symbol appears on the screen of the blood pressure monitor, it indicates the possible presence of atrial fibrillation. The atrial fibrillation diagnosis however, must be made by a cardiologist based on ECG interpretation.
Keep the arm still during measuring to avoid false readings.
This device may not or wrongly detect atrial fibrillation in
people with pacemakers or defibrillators. In the presence of atrial fibrillation the diastolic blood pressure
value may not be accurate. In the presence of atrial fibrillation using MAM-mode is recom-
mended for more reliable blood pressure measurement.

What is Atrial Fibrillation (AF)?

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 irregularly (this is called fibril­lation). Atrial fibrillation is the most common form of heart arrhythmia. It often causes no symptoms, yet it significantly increases your risk of stroke. You’ll need a doctor to help you control the problem.

Who should be screened for Atrial Fibrillation?

AF screening is recommended for people over 65 years of age, since the chance of having a stroke increases with age. AF screening is also recommended for people from the age of 50 years who have
EN
2BP B3 AFIB
high blood pressure (e.g. SYS higher than 159 or DIA higher than 99) as well as those with diabetes, coronary heart failure or for those who have previously had a stroke. In young people or in pregnancy AF screening is not recommended as it could generate false results and unnecessary anxiety. In addi­tion, young individuals with AF have a low risk of getting stroke as compared to elder people.

Risk factors you can control

Early diagnosis of AF followed by adequate treatment can signifi­cantly reduce the risk of getting stroke. Knowing your blood pressure and knowing whether you have AF is the first step in proactive stroke prevention. For more information visit our website: www.microlife.com/afib.

2. Using the Device for the First Time

Inserting the batteries

After you have unpacked your device, first insert the batteries. The battery compartment 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 flashes in the
display. You can set the year by pressing the M-button 3. To confirm and then set the month, press the MAM button 4.
2. Press the M-button to set the month. Press the MAM 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 MAM 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 MAM button 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 M 22 - 32 cm M - L 22 - 42 cm L 32 - 42 cm L - XL 32 - 52 cm
7
is on the bottom of the device. Insert the
Pre-shaped cuffs are optionally available.
Only use Microlife cuffs.
Contact your local Microlife Service if the enclosed cuff 8 does not fit.
Connect the cuff to the device by inserting the cuff connector 9 into the cuff socket 5 as far as it will go.

Selecting standard or MAM mode

Before each measurement, select standard (single measurement) or MAM mode (automatic triple measurement). In MAM mode, 3 measurements are automatically taken in succession and the result is then automatically analysed 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 MAM mode, press the MAM button 4 until the MAM-
symbol AO appears on the display. To change to standard mode (single measurement), press the MAM-button again, until the MAM-symbol disappears.
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.
AF detection is only activated in MAM mode.

3. 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
mended that doctors perform double arm measurements on a patients first visit in order to determine which arm to measure in the future. The arm with the higher blood pressur e 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.
(normally left). It is recom-
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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.

4. Taking a Blood Pressure Measurement

1. Select standard (single measurement) or MAM mode (automatic
triple measurement): see details in chapter «2.».
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 cuff fit check AR on the display indicates that the cuff is
perfectly placed. If the icon AR-A appears, the cuff is fitted suboptimally, but it is still ok to measure.
5. 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.
6. During the measurement, the pulse indicator BM flashes in the
display.
7. The result, comprising the systolic AL and the diastolic AM blood
pressure and the pulse rate AN 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.).
AF detection is only activated in MAM mode.
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). This monitor is specially tested for use in pregnancy and
pre-eclampsia. When you detect unusual high readings in pregnancy, you should measure after a short while again (eg. 1 hour). If the reading is still too high, consult your doctor or gynecologist. In pregnancy the AFIB symbol can be ignored.
Manual inflation In case of high systolic blood pressure (e.g. above 135 mmHg)
it can be an advantage to set the pressure individually. Press the ON/ OFF button after the monitor has been pumped up to a level of approx. 30 mmHg (shown on the display). Keep the button pressed until the pressure is about 40 mmHg above the expected systolic value – then release the button.

How not to store a reading

As soon as the reading is displayed press and hold the ON/OFF button 1 until «M» AP is flashing. Confirm to delete the reading by pressing the MAM button 4.
«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 BL points at the range within which the measured blood pressure value lies. The value is either within the optimum (green), elevated (yellow) or high (red) range. The classification corresponds to the following ranges defined by international guidelines (ESH, AHA, JSH). Data in mmHg.
Range Systolic Diastolic Recommendation
1. blood pressure too high
2. blood pressure elevated
3. blood pressure optimum
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 the Pulse Arrhythmia (PAD)

The pulse arrhythmia indicator BT is displayed, when pulse irregu­larities occurred during the measurement. If the symbol appears, select MAM mode and measure again: see details in chapter «2.».
In MAM mode Atrial Fibrillation (AF) will also be checked:
follow the directions in chapter «1.».
>135 >85 Seek medical
advice
130 - 135 80 - 85 Self-check
<130 <80 Self-check

5. Data Memory

This device automatically stores the last 99 measurement values.

Viewing the stored values

Press the M-button 3 briefly, when the device is switched off. The display first shows «AP and «A», which stands for the average
,
of all stored values. Pressing the M-button again displays the previous value. Pressing the M-button repeatedly enables you to move from one stored value to another.
Blood pressure readings with suboptimal cuff fit AR-A are
not considered in the average value.
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4BP B3 AFIB
Pay attention that the maximum memory capacity of 99
memories is not exceeded.
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.

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 ALL» appears and then release the button. To permanently clear the memory, press the MAM button while «CL ALL» is flashing. Individual values cannot be cleared.
Cancel deletion:
is flashing.
When the 99 memory is full, the
press ON/OFF button 1 while «
CL ALL

6. Battery Indicator and Battery change

Low battery

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

Flat battery – replacement

When the batteries are flat, the battery symbol AQ 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 7 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 2.».
The memory retains all values although date and time must
be reset – the year number therefore flashes automatically after the batteries are replaced.

Which batteries and which procedure?

Use 4 new, long-life 1.5 V, size AA alkaline 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.

7. Using a Mains Adapter

You can operate this device using the Microlife mains adapter
»
(DC 6V, 600 mA).
Only use the
accessory appropriate for your supply voltage. Ensure that neither the mains adapter nor the cable are
damaged.
1. Plug the adapter cable into the mains adapter socket 6 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.
Microlife
mains adapter available as an original

8. 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
«
Err 2
AR-B
»ASSignal too
weak
»
Error signal During the measurement, error signals
The pulse signals on the cuff are too weak. Re-position the cuff and repeat the measurement.*
When «Err 1» occurs, the device
performs a 15 second countdown, then repeats the measurement.
were detected by the cuff, caused for instance by movement or muscle tension. Repeat the measurement, keeping your arm still.
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