microlife BP 3AG1 Blood Pressure Monitor User Manual

IB BP 3AG1-30-gold EN-RU 2721
Revision Date: 2021-06-24

Microlife BP 3AG1

1.  ON/OFF button

2. Display

3. Cuff Socket

4. Mains Adapter Socket

5. Battery Compartment

6. Cuff

7. Cuff Connector

8. M-button (memory)
   Display

9. Systolic Value

10. AT Diastolic Value

11. AK Pulse Rate

12. AL Heart Arrhythmia Indicator

13. AM Pulse

14. AN Battery Display

15. AO Stored Value

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.

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.*
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 and Irish Hypertension Society (BIHS) protocol.

Table of Contents

1. Explanation of Symbols

2. Important Facts about Blood Pressure and Self-Measurement
   How do I evaluate my blood pressure?

3. Using the Device for the First Time
   • Inserting the batteries
   • Selecting the correct cuff

4. Taking a Blood Pressure Measurement

5.  The appearance of the Heart Arrhythmia Indicator for Early Detection

6. Data Memory
   • Viewing the stored values
   • Memory full
   • Clearing all values
   • How not to store a reading

7. Battery Indicator and Battery change
   • Low battery
   • Flat battery – replacement
   • Which batteries and which procedure?
   • Using rechargeable batteries

8. Using a Mains Adapter

9. Error Messages

10. Safety, Care, Accuracy Test and Disposal
    • Safety and protection
    •Device care
    • Accuracy test
    • Disposal

11. Guarantee

12. Technical Specifications
    Guarantee Card (see Back Cover)

Explanation of Symbols

| Batteries and electronic devices must be disposed of in accordance with the locally applicable regulations, not with domestic waste.
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| Read the instructions carefully before using this device.
**| Type BF applied part
IP20**| IP Class: IP20
| Keep dry
| Conformity mark
| Type approval of measuring device
| Serial number
| Catalog number
| Manufacturer
| Class II equipment
| Operating temperature restriction 10 – 40 °C
| Storage temperature restriction -20 – +55 °C
| CE Marking of Conformity

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 drugs or initiate treatment without consulting your doctor.
• Depending on physical exertion and condition, blood pressure is subject to wide fluctuations as the day progresses. You should therefore take your measurements in the same quiet conditions and when you feel relaxed! Take at least two measurements per day, one in the morning and one in the evening.
• It is quite normal for two measurements taken in quick succession 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 regularly as it can change drastically during this time.
• If you suffer from an irregular heartbeat (arrhythmia, see «Section 5.»), 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!

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.

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».

Using the Device for the First Time

Inserting the batteries
After you have unpacked your device, first insert the batteries. Battery compartment 5 is at the back of the device. Insert the batteries (4 x 1.5 V, size AA), thereby observing the indicated polarity.

Selecting the correct cuff
Microlife offers 3 different cuff sizes: S, M, and L. Select the cuff size to match the circumference of your upper arms (measured by close-fitting in the center of the upper arm).  M is the correct size for most people.

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 3 as far as it will go.

**** If you buy a spare Microlife cuff (size S, 17-22cm), please remove the cuff connector from the cuff tube from the cuff supplied with the original device and insert this cuff connector into the tube of the spare cuff (only valid for cuff size S).

Taking a Blood Pressure Measurement

Checklist for taking a reliable measurement

1. Avoid activity, eating, or smoking immediately before the measurement.

2. 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.

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 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 AM flashes in the display, and a beep sound every time a heartbeat is detected.

10. The result, comprising the systolic 9 and the diastolic AT blood pressure and the pulse rate AK is displayed and a long beep is heard. Note also the explanations on further display symbols in this booklet.

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

12. 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 (e.g. if you feel uneasy or have an unpleasant pressure sensation).

 The appearance of the Heart Arrhythmia Indicator for Early Detection

This symbol AL 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 Arrhythmia indicator
This device is an oscillometric blood pressure monitor that also analyses pulse frequency during measurement. The device is clinically tested.
The arrhythmia 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 seek medical advice.
This device does not replace a cardiac examination but serves to detect pulse irregularities at an early stage.

Data Memory

At the end of each measurement, this device automatically stores the result.

Viewing the stored values
Press the M-button AT briefly, when the device is switched off. The display first shows «M» AO 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 30 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.

How not to store a reading
Press the ON/OFF button 1 while the reading is being displayed.
Keep the button pressed until «M» AO is flashing and then release it. Confirm by pressing the M-button again.

Battery Indicator and Battery change

Low battery
When the batteries are approximately ¾ empty the battery symbol AN 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 AN 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 5 at the back of the device.
2. replace the batteries – ensure correct polarity as shown by the symbols in the compartment.

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.

Using a Mains Adapter

You can operate this device using the Microlife mains adapter (DC 6V, 600mA).

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 is damaged.

1. Plug the adapter cable into the mains adapter socket 4 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.

Error Messages

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

Re-position the cuff and repeat the measurement.
«ERR 2»| 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»| No pressure in the cuff| 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.
«HI»| Pulse or cuff pressure too high| 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.

• Please immediately consult your doctor, if this or any other problem occurs repeatedly.
  **** If you think the results are unusual, please read through the information in «Section 2.» carefully.

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.

• 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 is not a diagnosis. It is not replacing the need for the consultation of a physician, especially if not matching 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.

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.

Accuracy test
We recommend this device is tested for accuracy every 2 years or after mechanical impact (e.g. being dropped). The verification time period is 2 years. Verification is carried out in accordance with the document Р 1323565.2.001-2018 «State system for ensuring the uniformity of measurements. Non-invasive blood pressure meters. Verification Method» Confirmation of initial verification, an electronic version of the verification certificate, is on the website of the Federal Information Fund for Ensuring Uniformity of Measurements – www.fgis.gost.ru Information on verification is on the company website – www.microlife.ru

Disposal
When the disposal of this device is required please contact a specialized organization, authorized to provide utilization according to the legislation of the Russian Federation.

Guarantee

This device is covered by a 5-year guarantee from the date of purchase. The guarantee is valid only on the presentation of the guarantee card completed by the dealer (see back) confirming the date of purchase or the receipt.

• Batteries, cuff, and parts that become worn with use are not included.
• Opening or altering the device invalidates the guarantee.
• The guarantee does not cover damage caused by improper handling, discharged batteries, accidents, or non-compliance with the operating instructions.
  Please contact your local Microlife-Service (see foreword).

Technical Specifications

Operating conditions:| 10 – 40 °C / 50 – 104 °F 30 – 85 % relative maximum humidity
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Storage conditions:| -20 – +55 °C / -4 – +131 °F 30 – 85 % relative maximum humidity
Weight:| 400 g (including batteries)
Dimensions:| 140 x 120 x 70 mm
Measuring procedure:| oscillometric, corresponding to Korotkoff
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
Voltage source:| 4 x 1.5 V alkaline batteries; size AA Mains adapter DC 6V, 600 mA (optional)
Battery lifetime:| approx. 920 measurements (using new batteries)
Included accessories:| Cuff Tube Instruction manual Warranty card Batteries Power  Adapter Packaging Box
IP Class:| IP20
Reference to standards:| EN 1060-1 /-3 /-4; IEC 60601-1;
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.
Date of production: first four digits of the serial number of the device. First and second digit – the week of the year / third and fourth digit – the year of production.

Microlife AG
Espenstrasse 139
9443 Widnau / Switzerland
www.microlife.com

References

• Hypertension and Fever Management - Microlife AG

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