BP B3 AFIB - Blood pressure monitor MICROLIFE - Free user manual and instructions

Product Type	Electronic Blood Pressure Monitor
Brand and Model	Microlife BP B3 AFIB
Dimensions	138 x 94.5 x 62.5 mm
Weight (with batteries)	402 g
Main Power Supply	4 AA alkaline batteries 1.5 V
Mains Power Supply (optional)	DC 6 V, 600 mA adapter (Microlife)
Measurement Method	Oscillometric (Korotkoff phases I/V)
Pressure Measurement Range	20 – 280 mmHg
Pulse Measurement Range	40 – 199 beats/min
Pressure Accuracy	± 3 mmHg
Pulse Accuracy	± 5 % of reading
Display	LCD screen with date/time, pressures, pulse, IHB, AFIB, MAM indicators, classification, battery status
Main Functions	Single measurement, MAM mode (3 automatic measurements), atrial fibrillation detection (AFIB), irregular heartbeat detection (IHB), color-coded assessment (green/yellow/red)
Memory	99 measurements with date/time, calculated average
Included Cuff	Size M (22-32 cm), other sizes available
Operation	Automatic inflation, automatic deflation, manual inflation possible
Operating Conditions	Temperature 10-40 °C, relative humidity 15-90 % max
Storage Conditions	Temperature -20 to +55 °C, relative humidity 15-90 % max
Warranty	5 years (device), 2 years (cuff)
Maintenance	Clean with a dry cloth; cuff washable by hand (max 30 °C, no fabric softener)
Standards and Safety	CE medical device, EMC compatible, IP20, contraindicated in children under 12 years

Frequently Asked Questions - BP B3 AFIB MICROLIFE

How to set the date and time on the blood pressure monitor?

After installing the batteries, the year flashes. Use the M button to change the value, then press MAM to confirm and move to the next setting (month, day, hour, minutes). To change after installation, press and hold MAM for 3 seconds until the year flashes.

What does the AFIB symbol on the screen mean?

The AFIB symbol appears after a measurement in MAM mode if possible atrial fibrillation (AF) is detected. This is not a diagnosis; consult a doctor for an ECG evaluation. The symbol is ignored during pregnancy.

How to select MAM mode (triple measurement)?

Press the MAM button until the MAM symbol appears on the screen. The device will then perform 3 automatic measurements with a 15-second interval and display the average. Press MAM again to return to standard mode (single measurement).

What to do if an error code, e.g. 'Err 2', appears?

Err 2 indicates an incorrect signal due to arm movement or muscle tension. Repeat the measurement without moving and remaining relaxed. See 'Error Messages' section of the manual for other codes like Err 1 (cuff incorrectly positioned) or Err 3 (cuff leak).

How to clean the cuff?

Detach the cuff cover from the tube, remove the air bag. Hand wash the cover in soapy water at maximum 30 °C. Do not machine wash, do not use fabric softener, and do not tumble dry. Reinsert the air bag flat once the cover is dry.

How many measurements can the device store in memory?

Up to 99 measurements. Beyond that, the oldest is replaced by the new one. The average of measurements can be accessed by pressing the M button. To clear all memory, press and hold M until 'CL ALL' appears, then press MAM.

What is the warranty period for the device?

The device is warranted for 5 years from the date of purchase. The cuff is warranted for 2 years. The warranty covers manufacturing defects, but not damage due to misuse, battery leakage, or normal wear of accessories (batteries, adapter).

Can I use this device during pregnancy?

Yes, it has been tested for pregnancy and pre-eclampsia. In case of unusually high readings, wait one hour and take another measurement. If the reading remains too high, consult your doctor. During pregnancy, the AFIB symbol can be ignored.

How to interpret the colors (green, yellow, red) on the screen?

The colored triangle on the left of the screen indicates classification: green: normal blood pressure (< 130/80 mmHg), yellow: elevated blood pressure (130-134/80-84 mmHg), red: too high blood pressure (≥135/85 mmHg). The higher value (systolic or diastolic) determines the classification.

What type of batteries to use and how to replace them?

Use 4 AA alkaline batteries 1.5 V. Open the compartment under the device, respect polarity. Do not use batteries past their expiration date. The device also works with rechargeable NiMH batteries, but they must be recharged in an external charger.

USER MANUAL BP B3 AFIB MICROLIFE

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5.

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6.

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Microlife BP B3 AFIB Microlife BP B3 AFIB Microlife BP B3 AFIB Guarantee Card Before each measurement

①-A ②-B ③-C

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1.

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2.

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3.

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
⑩ Cuff tube

Display

⑪ Date/Time
⑫ Systolic value
⑬ Diastolic value
⑭ Pulse rate
⑮ MAM Mode
⑯ Stored value
⑰ Battery display
⑱ Cuff fit check

-A: Suboptimal cuff fit
-B: Arm movement indicator «Err 2»
-C: Cuff pressure check «Err 3»

⑲ Cuff signal indicator «Err 1»
⑳ Irregular heartbeat (IHB) symbol
②1 Atrial Fibrillation Indicator (AFIB)
② Traffic light indicator
②3 Pulse indicator

Read the important information in these instructions for use before using this device. Follow the instructions for use for your safety and keep it for future reference.

Type BF applied part

Keep dry

Manufacturer

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

Authorized representative in the European Community

Catalogue number

Serial number

(YYYY-MM-DD-SSSSS;

year-month-day-serial number)

Caution

Humidity limitation

Temperature limitation

Medical device

Keep away from children of age 0 - 3

C€0044

CE Marking of Conformity

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 and Irish Hypertension Society (BIHS) 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.
^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 irregular heartbeat (IHB) symbol
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
   Device care
   Cleaning the cuff
   Accuracy test
   Disposal
10. Guarantee
11. Technical Specifications

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 ② 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 recommended 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 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 ⑦ 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 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

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 ⑮ 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 your 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 patients 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.

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 ⑱ on the display indicates that the cuff is perfectly placed. If the icon ⑱-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 ②3 flashes in the display.

7. The result, comprising the systolic ⑫ and the diastolic ⑬ blood pressure and the pulse rate ⑭ are 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 or open the cuff (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» ⑯ 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 ②2 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, ESC, JSH). Data in mmHg.

Range Systolic Diastolic Recommendation
1. blood pressure too high	≥135 ≥85	Seek medical advice
2. blood pressure elevated	130 - 134	80 - 84 Self-check

Range Systolic Diastolic Recommendation
3. blood pressure normal	<130 <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 the irregular heartbeat (IHB) symbol

This symbol ⑳ indicates that an irregular heartbeat was detected. In this case, the measured blood pressure may deviate from your actual blood pressure values. It is recommended to repeat the measurement.

Information for the doctor in case of repeated appearance of the IHB symbol:

This device is an oscillometric blood pressure monitor that also measures the pulse during blood pressure measurement and indicates when the heart rate is irregular.

In MAM mode Atrial Fibrillation (AF) will also be checked: follow the directions in chapter ««1. Appearance of the Atrial Fibrillation Indicator for early Detection (Active only in MAM mode)».
If the symbol appears, select MAM mode and measure again: see details in chapter ««2. Using the device for the first time»».

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 «M» ⑯, 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 18-A are not considered in the average value.

Pay attention that the maximum memory capacity of 99 memories is not exceeded. When the 99 memory is full, the oldest value is automatically overwritten with the 100 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: press ON/OFF button ① while «CL ALL» is flashing.

6. Battery indicator and battery change

Low battery

When the batteries are approximately 34 empty the battery symbol ⑰ 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 ⑰ 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. Using the device for the first time》.

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 Microlife mains adapter available as an original 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.

8. Error Messages

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

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

Error Description Potential cause and remedy
«Err 1»19	Signal too weak	The pulse signals on the cuff are too weak. Re-position the cuff and repeat the measurement.*
«Err 2»18-B	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»18-C	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 taking a reliable measurement and then repeat the measurement.*
«Err 6» MAM Mode There were too many errors during the measurement in MAM mode, making it impossible to obtain a final result. Read through the checklist for taking a reliable measurement 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.*

9. 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 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 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.
  • The cuffs are sensitive and must be handled with care.
  • Only pump up the cuff once fitted.
• Do not use this device if you think it is damaged or notice anything unusual.
  • Never open this device.
• 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.

Contra-indications

Do not use this device if the patient's condition meets the following contra-indications, to avoid inaccurate measurements or injuries.

• The device is not intended for measuring blood pressure in pediatric patients of age younger than 12 years old (children, infant, or neonates).
• 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.

• The device measures blood pressure using a pressured cuff. If the measuring limb suffers from injuries (for example open wounds) or under conditions or treatments (for example intravenous drip) making it unsuitable for surface contact or pressurization, do not use the device, to avoid worsening of the injuries or conditions.

• Patient motions during measurement may interfere with the measurement process and influence results.

• Avoid taking measurements of patients with conditions, diseases, and susceptible to environment conditions that lead to uncontrollable motions (e.g. trembling or shivering) and inability to communicate clearly (for example children and unconscious patients).
• The device uses oscillometric method to determine blood pressure. The arm being measure should have normal perfusion. The device is not intended to be used on a limb with restricted or impaired blood circulation. If you suffer with perfusion or blood disorders, consult your doctor before using the device.
• Avoid taking measurement on the arm on the side of a mastectomy or lymph node clearance.
• Do not use this device in a moving vehicle (for example in a car or on an aircraft).

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 intended uses described in this Instructions for Use. The manufacturer cannot be held liable for damage caused by incorrect application.
• 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.
• Blood flow of the arm is temporarily interrupted during measurement. Extended interruption of blood flow reduces peripheral circulation and may cause tissue injury. Beware of signs (for example tissue discoloration) of impeded peripheral circulation if taking measurements continuously or for an extended period of time.

• Prolonged exposure to cuff pressure will reduce peripheral perfusion and may lead to injury. Avoid situations of extended cuff pressurization beyond normal measurements. In the case of abnormally long pressurization, abort the measurement or loose the cuff to depressurize the cuff.

• 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.
• 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.
• Keep the device away from children and people incapable of operating the device. Beware of the risks of accidental ingestion of small parts and of strangulation with the cables and tubes of this device and accessories.

CAUTION

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.
• After a measurement is completed, loosen the cuff and rest for > 5 minutes to restore limb perfusion, before taking another measurement.
• 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 in proximity of high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, and computerized tomography (CT) scanners. This may cause device malfunction and measurement inaccuracies.
• Use and store the device, cuff and parts in temperature and humidity conditions specified in the «Technical Specifications». Usage and storage of the device, cuff and parts in conditions outside ranges given in the «Technical Specifications» may results in device malfunction and the safety of usage.
• Protect the device and accessories from the following to avoid damaging the device:
  — water, other liquids, and moisture
  — extreme temperatures
  — impacts and vibrations
• direct sunlight
  — contamination and dust

- Stop using this device and cuff and consult with your doctor if you experience skin irritation or discomfort.

Electromagnetic Compatibility Information

This device is compliant with EN60601-1-2: 2015 Electromagnetic Disturbances standard.

This device is not certified to be used in vicinity of High Frequency (HF) medical equipment.

Do not use this device close to strong electromagnetic fields and portable radio frequency communication devices (for example microwave oven and mobile devices). Keep a minimum distance of 0.3 m from such devices when using this device.

Device care

Clean the device only with a soft, dry cloth.

Cleaning the cuff

The cuff delivered with this device is washable.

1. Remove the cuff connector ⑨ from the cuff tube ⑩ and carefully pull the bladder through the opening at the edge of the cuff cover.
2. Hand wash the cuff cover in soapsuds: not hotter than 30^ C.
3. Completely dry the cuff cover by linen drying.
4. Loop the cuff tube back through its opening and carefully place the bladder flat in the cuff cover.
5. Reattach the cuff connector on the cuff tube.

The bladder must lay straight in the cuff cover, not folded.

Do not use fabric softener.

WARNING: Do not wash the cuff in a washing machine or dishwasher!

WARNING: Do not dry the cuff cover in a tumble dryer!

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.

10. 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 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 guarantee does not prolong or renew the guarantee period. The legal claims and rights of consumers are not limited by this guarantee.

11. Technical Specifications

Operating

10 - 40 °C / 50 - 104 °F

conditions:

15-90 % relative maximum humidity

Storage conditions: -20 - +55 °C / -4 - +131 °F

15-90 % relative maximum humidity

Weight: 402 g (including batteries)

Dimensions: 138 x 94.5 x 62.5 mm

Cuff size: from 17-52 cm according to the cuff sizes

(see «Selecting the correct cuff»)

Measuring oscillometric, corresponding to

procedure: Korotkoff method: Phase I systolic, Phase V diastolic

Measurement range: 20 - 280 mmHg – blood pressure

40 - 199 beats per minute – pulse

Cuff pressure 0 - 299 mmHg

display range:

Resolution: 1 mmHg

Static accuracy: 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)

IP Class: IP 20

Reference to EN 1060-1 /-3 /-4; IEC 60601-1;

standards: IEC 60601-1-2 (EMC); IEC 60601-1-11

Expected Device: 5 years or

service life: 10000 measurements, whichever comes first Accessories: 2 years or 5000 measurements, whichever comes first

This device complies with the requirements of the Medical Device

Directive 93/42/EEC.

Technical alterations reserved.

Microlife BP B3 AFIB

ES

^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.

^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.

Sommaire

www.microlife.com/support

^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.

^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.

Inhaltsverzeichnis

www.microlife.com/support

www.microlife.com/support

www.microlife.com/support

^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.

^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.

Inhoudsopgave

^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.
^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.

[Illegible Handwriting]

. 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 : e004565.Wiesel J, Arbesfeld B, Schechter D 4: Comparison of the Microlife blood pressure monitor with the Omron blood pressure monitor for detecting .atrial fibrillation. Am J Cardiol 2014; 114:1046-1048

لاطمتهاة

IEC 60601-1-2 (EMC); IEC

60601-1-11