microlife BPA7 Touch BT Blood Pressure Monitor Instructions

BPA7 Touch BT
Bluetooth®
Blood Pressure Monitor

 Microlife AG
Espenstrasse 139
9443 Widnau / Switzerland
0044
www.microlife.com
 Microlife UAB
P. Lukšio g. 32,
08222 Vilnius / Lithuania
IB BP A7 Touch BT E-V11 3321
Revision Date: 2021-08-11

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Preparation

1. Sit on a back-supported chair and keep your legs uncrossed.| 2. Avoid thick or close-fitting garments on the upper arm.
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3. Place the artery mark on the cuff over your artery.| 4. Fit the cuff closely, but not too tight.
 5. Position the cuff 1-2 cm above your elbow.|  6. Keep your arm still and do not speak during the measurement

Microlife BP A7 Touch BT

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Before each measurement
Microlife BP A7 Touch BT

1. | 1. Avoid eating, bathing, smoking, or caffeine (approx. 30 min).
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2. | 2. Avoid activity and relax for 5-10 min.
3.  | 3. Measure before medication intake.

Guarantee Card

Name of Purchaser|
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Serial Number|
Date of Purchase|
Specialist Dealer|
Microlife BP A7 Touch BT
1. Enter
2. Display
3. Lock Switch
4. Cuff Socket
5. AFIB/MAM Switch
6. + «Forward» Button
7. – «Backward» Button
8. USB Port
9. Mains Adapter Socket
10. AT Battery Compartment
11. AK Cuff
12. AL Cuff Connector
13. AM Cuff Tube| Display
14.  START/STOP Button
15.  M-button (memory)
16.  Systolic Value
17  Diastolic Value
18.  Pulse Rate
19.  Battery Display
20.  Cuff Check Indicator
21.  Arm Movement Indicator
22.  Atrial Fibrillation Indicator (AFIB)
23.  User Indicator
24.  AFIB/MAM Mode
25. AFIB/MAM Interval Time
26. Traffic Light Indicator
27. Date/Time
28. Pulse Indicator
29. Active Bluetooth®
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Read the instructions carefully before using this device.
Type BF applied part
Keep dry

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 were carried out to 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%. ¹·²
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 info- mention 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 and Irish Hypertension Society (BIHS) protocol.
  ¹Kearley 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.
  ²Wiesel 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.

Appearance of the Atrial Fibrillation Indicator for Early Detection (Active only in AFIB/MAM mode)

This device is able to detect atrial fibrillation (AF). This symbol BL 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 the 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 AFIB/MAM-mode is recommended for a more reliable blood pressure measure- meant.
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. A  screening is also recommended for people from the age of 50 years who have 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 addi- tion, young individuals with AF have a low risk of getting a 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.

Using the Device for the First Time

Inserting the batteries
After you have unpacked your device, first insert the batteries. The battery compartment AT is on the bottom of the device. Insert the batteries (4 x 1.5 V, size AAA), 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 either the «+» 6 or the «-» 7 button. To confirm and then set the month, press enters 1.
2. Press the «+» 6 or the «-» 7  button to set the month. Press enter 1 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 Date/ Time BQ for approx. 3 seconds until the year number starts flashing. 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  lose fitting in the center of the upper arm).

Only use Microlife cuffs.

• Contact your local Microlife Service if the enclosed cuff AK does not fit.
•  Connect the cuff to the device by inserting the cuff connector AL into the cuff socket 4 as far as it will go.

Selecting the user
This device allows to the storage of the results for 2 individual users. In addition, there is a guest mode in which results are not stored.

• Before each measurement, set the user indicator BM for the intended user: user 1, user 2, or guest mode.
•  Press and hold the user indicator BM for approx. 2 seconds until the user symbol starts flashing. Now select user 1, user 2, or guest mode by pressing the user indicator again. Wait 2- 3 seconds to confirm your selection.
   The first person to measure should select user 1.

Selecting standard or AFIB/MAM mode
Before each measurement, select standard (single measurement) or AFIB/MAM mode (automatic triple measurement). In AFIB/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.

• When you select the 3 measurements, the AFIB/MAM-symbol BN appears in the display.
• The bottom, right-hand section of the display shows a 1, 2, or 3 to indicate which of the 3  easurements 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 AFIB/MAM mode.

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 1-2 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.

Taking a Blood Pressure Measurement

1. Slide the lock switch 3 down to the «unlock» position.
2. Select standard (single measurement) or AFIB/MAM mode (automatic triple measurement): see details in chapter «2.».
3. Press the START/STOP button AN to start the measurement.
4. 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.
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 BR flashes in the display.
7. The result, comprising the systolic AP and the diastolic AQ blood pressure and the pulse rate  AR 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 AFIB/MAM mode.
   You can stop the measurement at any time by pressing the START/STOP button (e.g. if you feel uneasy or have 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.

How not to store a reading
As soon as the reading is displayed press and hold the START/ STOP button AN until «M» AO is flashing. Confirm to delete the reading by pressing the M-button AO.
 «CL» is displayed when the reading is deleted from the memory successfully.
How do I evaluate my blood pressure?
The LED traffic light indicator on the left-hand side of the display BP indicates within which range the measured blood pressure 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, ESC, JSH). Data in mmHg.

The higher value is the one that determines the evaluation. For example, a blood pressure value of 140/80 mmHg or a value of 130/90 mmHg indicates «blood pressure too high».

Data Memory

This device automatically stores up to 99 measurement values for each of the 2 users and guest mode.
Viewing the stored values
Switch the lock switch 3 to the «unlock» position. Select either user 1 or 2 with the user indicator BM. Press the M-button  AO briefly. The display shows an average value. 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 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.
Clearing all values
Make sure the correct user is activated.

1. Firstly unlock the device 3, then select either 1 or 2 with the user indicator BM.
2. Hold down the M-button AO until «CL» appears and then release the button.
3. Press the M-button while «CL» is flashing to permanently clear all values of the selected user.

Cancel deletion: press START/STOP button AN while «CL» is flashing.
Individual values cannot be cleared.

 Battery Indicator and Battery change

Low battery
When the batteries are approximately ¾ empty the battery symbol AS 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 AS 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 a date and time, follow the procedure described in «Section 2.».
   The memory retains all values although the 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 AAA 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.

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.
Ensure that neither the mains adapter nor the cable is damaged.
1. Plug the adapter cable into the mains adapter socket 9 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.

Bluetooth® Function

This device can be used in conjunction with a smartphone running the «Microlife Connected  Health+» App. The Bluetooth® connection is automatically activated after the measurement has been completed.
To manually activate the Bluetooth®, press START/STOP AN for 5 – 6 seconds until the  Bluetooth symbol starts flashing BS.
For more detailed information visit www.microlife.com/connect.

PC-Link Functions

This device can be used in conjunction with a personal computer (PC) running the Microlife Blood  Pressure Analyzer+ (BPA+) software. The memory data can be transferred to the PC by connecting the monitor via a cable. If no download-voucher and cable are included download the  BPA+ software from www.microlife.com/software and use a Micro-USB cable.

Error Messages

If an error occurs during the measurement, the measurement is interrupted and an error message, e.g. «Err 3», is displayed.

The pulse signals on the cuff are too weak. Re-position the cuff and repeat the measurement.*

« Err 2 » 21| Error signal|

During the measurement, error signals were detected by the cuff, caused for instance by movement or muscle tension. Repeat the measurement, keeping your arm still.

« Err 3 » 20| Abnormal cuff pressure|

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.

« Err 5 »| Abnormal result|

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.*

« Err 6 »| AFIB/MAM  Mode|

There were too many errors during the measurement in AFIB/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 299 mmHg) OR the pulse is too high (over 200 beats per minute). Relax for 5 minutes and repeat the measurement.*

« LO »| Pulse too low| The pulse is too low (less than 40 beats per minute). Repeat the measurement.*
| Problem| If any problem occurs with the Bluetooth
with Blue-| connection, the Bluetooth® icon BS
tooth®| blinks rapidly for approximately 10
connection| seconds. To solve the problem, please visit www.microlife.com/connect.

• Please immediately consult your doctor, if this or any other problem occurs repeatedly.

Safety, Care, Accuracy Test, and Disposal

Safety and protection

• Follow instructions for use. This document provides important product operation and safety information regarding this device. Please read this document thoroughly before using the device and keep it for future reference.
• This device may only be used for the purposes described in these instructions. The manufacturer cannot be held liable for damage caused by the incorrect application.
•  This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in the «Technical Specifications» section.
• Protect it from –  water and moisture – extreme temperatures – impact and dropping – contamination and dust –  direct sunlight – heat and cold
• The cuffs are sensitive and must be handled with care.
• Do not exchange or use any other kind of cuff or cuff connector for measuring with this device.
• Only pump up the cuff once fitted.
• 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.
• Do not use this device if you think it is damaged or notice anything unusual.
• Never open this device.
• If the device is not going to be used for a prolonged period the batteries should be removed.
•  Read the additional safety information provided within the individual sections of this instruction manual.
• The measurement results given by this device are not a diagnosis. It is not replacing the need for the consultation of a physician, especially if not match the patient’s 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.
• Under no circumstances should you alter the dosages of drugs or initiate treatment without consulting your doctor.
•  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!
•  If you are pregnant, you should monitor your blood pressure regularly as it can change drastically during this time.
   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.

Device care   Clean the device only with a soft, dry cloth.
Cleaning the cuff
Carefully remove spots on the cuff with a damp cloth and soap- suds.

WARNING: Under no circumstances may you wash the inner bladder!
Accuracy test
We recommend this device is tested for accuracy every 2 years or after mechanical impact (e.g. being dropped). Please contact your local Microlife- Service to arrange the test (see foreword).

Disposal
Batteries and electronic devices must be disposed of in accordance with the locally applicable regulations, not with domestic waste.

Guarantee

This device is covered by a 5-year guarantee from the date of purchase. During this guarantee period, at our discretion, Microlife will repair or replace the defective product free of charge. Opening or altering the device invalidates the guarantee. The following items are excluded from the guarantee:

• Transport costs and risks of transport.
• Damage caused by incorrect application or non-compliance with the instructions for use.
• Damage caused by leaking batteries.
•  Damage caused by accident or misuse.
•  Packaging/storage material and instructions for use.
• Regular checks and maintenance (calibration).
•  Accessories and wearing parts: Batteries, power adapter (optional).
  The cuff is covered by a functional guarantee (bladder tightness) for 2 years. Should guarantee service to be required, please contact the dealer from where the product was purchased or your local Microlife service. You may contact your local Microlife service through our website: www.microlife.com/support
  Compensation is limited to the value of the product. The guarantee will be granted if the complete product is returned with the original invoice. Repair or replacement within the guarantee does not prolong or renew the guarantee period. The legal claims and rights of consumers are not limited by this guarantee.

Technical Specifications

Operating conditions:| 10 – 40 °C / 50 – 104 °F
15 – 95 % relative maximum humidity
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Storage conditions:| -20 – +55 °C / -4 – +131 °F
15 – 95 % relative maximum humidity
Weight:| 312 g (including batteries)
Dimensions:| 160 x 82 x 35 mm
Measuring procedure:| oscillometric, corresponding to Korotkoff method: Phase I systolic, Phase V diastolic
Measurement range:| 20 – 280 mmHg – blood pressure 40 – 200 beats per minute – pulse
Cuff pressure
display range:| 0 – 299 mmHg
Resolution:| 1 mmHg
Static accuracy:| pressure within ± 3 mmHg
Pulse accuracy:| ± 5 % of the readout value
Communication:| Bluetooth® 4.0
Compatibility:| iOS: iOS 10.0 or newer Android: Android OS 5 or newer
Voltage source:| 4 x 1.5 V alkaline batteries; size AAA Mains adapter DC 6V, 600 mA (optional)
Battery lifetime:| approx. 400 measurements (using new batteries)
IP Class:| IP20
Reference to| EN 1060-1 /-3 /-4; IEC 60601-1;
standards:| IEC 60601-1-2 (EMC); IEC 60601-1-11
Expected service life:| Device: 5 years or 10000 measurements Accessories: 2 years

This device complies with the requirements of the Medical Device Directive 93/42/EEC. Technical alterations reserved. The Bluetooth®  word mark and logos are registered trademarks owned by Bluetooth SIG, Inc., and any use of such marks by Micro- life Corp. is under license. Other trademarks and trade names are those of their respective owners.

References

• The Most Iconic Photographs of All Time - LIFE
• Hypertension and Fever Management - Microlife AG
• Hypertension and Fever Management - Microlife AG
• Connect - Microlife AG
• Request Support Microlife BP Analyzer+ Software - Microlife AG
• Support - Microlife AG
• Preventief je gezondheid managen - Microlife Nederland - Microlife AG

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