Microlife BP B2 Basic Blood Pressure Monitor

Introduction

The Microlife BP B2 Basic is an oscillometric blood pressure monitor designed for non-invasive measurement of blood pressure in individuals aged 12 years and older. It has been clinically validated for patients with hypertension, hypotension, diabetes, pregnancy, pre-eclampsia, atherosclerosis, end-stage renal disease, obesity, and the elderly. This device was developed in collaboration with physicians, and clinical validation studies have demonstrated high measurement accuracy.

Preparation for Measurement

Proper preparation ensures accurate readings:

1. Positioning: Sit on a chair with back support, keeping your legs uncrossed and feet flat on the floor.
2. Clothing: Avoid wearing thick or tight-fitting garments on the upper arm. If necessary, remove clothing or roll up sleeves, ensuring they do not constrict the arm.
3. Cuff Placement:
   • Position the cuff 1-2 cm above your elbow.
   • Align the artery mark on the cuff with your brachial artery (inner side of the arm).
   • Ensure the cuff is snug but not too tight.
4. Arm Support: Support your arm so it is relaxed and at heart level.

Diagram Description: Visuals illustrate correct sitting posture, appropriate arm positioning, and cuff placement on the upper arm, highlighting the artery mark alignment and the 1-2 cm distance from the elbow.

Before Each Measurement

• Avoid eating, bathing, smoking, or consuming caffeine for approximately 30 minutes before measurement.
• Relax for 5-10 minutes before taking the measurement.
• Measure before taking any medication.

How to Measure Blood Pressure

1. Press the ON/OFF button [ON/OFF button] to start the measurement.
2. The cuff will inflate automatically. Remain still, do not speak, and do not tense your arm muscles until the result is displayed. Breathe normally.
3. A cuff control indicator [Cuff control indicator] will appear on the display if the cuff is correctly placed. If the cuff position check symbol [Cuff position check] appears, the cuff is moderately placed but a correct measurement may still be possible.
4. Once the correct pressure is reached, inflation stops, and the cuff pressure slowly decreases. If the target pressure is not reached, the device will automatically pump more air into the cuff.
5. During measurement, the pulse symbol [Pulse symbol] will flash on the display.
6. The result, including systolic and diastolic blood pressure and pulse rate, will be displayed.
7. When the measurement is complete, remove the cuff.
8. Turn off the device using the ON/OFF button [ON/OFF button]. The monitor automatically switches off after approximately 1 minute. You can stop the measurement at any time by pressing the ON/OFF button or opening the cuff.

Manual Inflation Setting: For high systolic blood pressure (e.g., above 135 mmHg), you can manually set the inflation. Press and hold the ON/OFF button when the cuff inflates to approximately 30 mmHg. Continue holding until the pressure is about 40 mmHg higher than the expected systolic value, then release the button.

Performing a Measurement Without Saving: After a measurement is displayed, press and hold the ON/OFF button [ON/OFF button] until the 'M' symbol [M button] appears. Then press the Time button [Time button] to delete the measurement. 'CL' will appear to confirm deletion.

Blood Pressure Classification: The triangular symbol [Traffic light indicator] on the display classifies home blood pressure readings according to international guidelines (ESH, ESC, JSH). Values are shown in mmHg.

Example: A reading of 140/80 mmHg or 130/90 mmHg indicates 'Blood pressure too high'.

Irregular Heartbeat (IHB) Symbol: This symbol [Irregular heartbeat (IHB) symbol] indicates that an irregular heartbeat has been detected. In such cases, the measured blood pressure may differ from your actual blood pressure. Repeating the measurement is recommended. If the IHB symbol appears repeatedly, consult your doctor.

Memory Storage

The device stores the last 30 measurements. To view stored values, press the M button [M button] when the device is off. The display will show 'M' [M button] and 'A' for the average of all stored values. Pressing the M button [M button] again scrolls through previous readings. Measurements with a moderate cuff position (AR-A) are not included in the average. The memory capacity is 30 measurements; when full, the oldest measurement is automatically overwritten. To prevent data loss, have values evaluated by a doctor before the memory is full.

Clearing All Values: To permanently delete all stored values, press and hold the M button [M button] (with the device off) until 'CL ALL' appears, then release the button. Press the Time button [Time button] while 'CL ALL' flashes to permanently clear the memory. Individual measurements cannot be deleted.

Battery Indicator and Replacement

Batteries Nearly Empty: When batteries are about 1/4 depleted, the battery indicator [Battery indicator] will flash when the device is switched on. The device will continue to measure reliably, but batteries should be replaced soon.

Batteries Empty – Replacement: When batteries are empty, the battery indicator [Battery indicator] will flash when the device is switched on, indicating empty batteries. Measurement cannot continue until batteries are replaced.

1. Open the battery compartment [Battery compartment] at the back of the device.
2. Replace batteries, ensuring correct polarity as shown by the symbols in the compartment.
3. To set the date and time, follow the procedure described in the 'First Use of the Device' section. The memory retains all values, but date and time must be reset; the year will flash automatically after battery replacement.

Battery Types: Use 4 new, long-life 1.5V, type AA alkaline batteries. Do not use batteries past their expiry date. Remove batteries if the device will not be used for an extended period. Rechargeable NiMH batteries can be used, but must be removed and charged externally. Do not leave rechargeable batteries in the device when depleted, as they may be damaged.

Using an AC Adapter

The device can be used with a Microlife AC adapter (DC 6V, 600 mA). Use only the original Microlife adapter. Ensure the adapter and cable are not damaged. Plug the adapter cable into the adapter connection [Adapter connection] on the blood pressure monitor, and then plug the adapter into a wall socket. No battery power is used when the adapter is connected.

Error Messages

If an error occurs, the measurement will be interrupted, and an error message (e.g., 'ERR 3') will be displayed.

* Please contact your doctor immediately if this or any other problem occurs frequently.

Safety, Maintenance, Accuracy Test, and Disposal

Safety and Protection

• Follow instructions for correct use. Read this documentation carefully before using the device and keep it for future reference.
• The device is intended only for the purpose described in this manual. The manufacturer is not liable for damage caused by incorrect use.
• Handle the device with care as it contains sensitive components. Observe storage and operating instructions.
• The cuff is delicate and requires careful handling.
• Only inflate the cuff when it is applied to the arm.
• Do not use the device if you suspect it is damaged or if you notice anything unusual during use.
• Never open the device.
• Read further safety instructions in separate paragraphs.
• Measurement results do not constitute a diagnosis. They do not replace a doctor's consultation, especially if symptoms do not match. Do not rely solely on the measurement result; consider other symptoms and patient feedback. Consult your doctor if in doubt.
• Children should use the device only under adult supervision. Small parts can be swallowed. Be aware of the risk of entanglement if the device has cables or hoses.

Contraindications

Do not use this device if the patient's condition meets the following contraindications to prevent inaccurate measurements or injuries:

• The device is not intended for measuring blood pressure in pediatric patients younger than 12 years (infants or newborns).
• Significant arrhythmias during measurement can distort blood pressure readings and affect reliability. Consult your doctor about the suitability of the device in such cases.
• Do not use the device on limbs with injuries (e.g., open wounds) or conditions/treatments (e.g., intravenous infusion) that make contact with the surface or pressure application unsuitable, to prevent worsening of the condition.
• Patient movements during measurement can interfere with the process and affect results.
• Avoid measuring patients with conditions, diseases, or those susceptible to environmental conditions causing uncontrollable movements (e.g., tremors, shivering) or patients who cannot communicate clearly (e.g., children, unconscious patients).
• The arm measured must have normal perfusion. The device is not intended for use on a limb with impaired circulation. Consult your doctor if you have circulation or blood disorders.
• Avoid measurements on the arm on the side of a mastectomy or lymph node removal.
• Do not use the device in a moving vehicle (e.g., car or airplane).

⚠️ WARNING: Indicates a potentially hazardous situation that, if not avoided, could result in death or serious injury.

• Use the device only for its intended purpose as described in this manual. The manufacturer is not liable for damage caused by improper application.
• Do not change medication or treatment based on measurement results. Changes should only be prescribed by a medical professional.
• Inspect the device, cuff, and other parts for damage. DO NOT use if they appear damaged or malfunction.
• Blood flow is temporarily interrupted during measurement. Prolonged interruption can reduce peripheral circulation and cause tissue damage. Watch for signs of impaired peripheral circulation (e.g., tissue discoloration) if performing continuous or prolonged measurements.
• Prolonged cuff pressure can reduce peripheral perfusion and lead to injury. Avoid prolonged cuff pressure beyond normal measurements. If an abnormally long pressure application occurs, stop the measurement or release the cuff pressure.
• Do not use in oxygen-rich environments or near flammable gas.
• The device is not water-resistant. Do not spill liquids on it or immerse it in water.
• Do not disassemble or attempt to repair the device, accessories, or parts. Unauthorized access or maintenance can compromise safety and performance.
• Keep the device away from children and persons unable to operate it. Be aware of risks from swallowing small parts or entanglement with cables.

ℹ️ CAUTION: Indicates a potentially hazardous situation that, if not avoided, may result in minor or moderate injury to the user or patient, or damage to the device or other property.

• The device is intended solely for measuring blood pressure on the upper arm. Measuring other areas may yield inaccurate results.
• After a measurement, release the cuff and rest for at least 5 minutes to restore limb perfusion before taking another measurement.
• Do not use this device simultaneously with other medical electrical (ME) equipment, as it may cause interference or inaccurate measurements.
• Do not use the device near high-frequency (HF) surgical equipment, Magnetic Resonance Imaging (MRI) equipment, or Computed Tomography (CT) scanners, as this can cause interference or inaccurate measurements.
• Use and store the device, cuff, and parts under the specified temperature and humidity conditions. Using or storing them outside these ranges can lead to device defects and compromise safety.
• Protect the device and accessories from: water, other liquids, extreme temperatures, impact, vibration, direct sunlight, and dust.
• Stop using the device and cuff and consult your doctor if you experience skin irritation or discomfort.

Information on Electromagnetic Compatibility (EMC)

This device complies with the EN 60601-1-2: 2015 standard for electromagnetic disturbances. It is not certified for use near high-frequency (HF) medical equipment. Avoid strong electromagnetic fields and portable radio frequency communication devices (e.g., microwaves, mobile phones). Maintain a minimum distance of 0.3 m from such devices when using the BP monitor.

Device Maintenance

Clean the device only with a soft, dry cloth.

Cleaning the Cuff

The cuff cover supplied with the device is washable.

1. Remove the cuff connector [Cuff connector] from the cuff tubing [Cuff tubing] and carefully pull the bladder through the opening.
2. Wash the cuff cover in water not warmer than 30 °C.
3. Dry the cuff with a dry cloth.
4. Reinsert the bladder through the opening into the cuff cover and carefully flatten the bladder. The bladder must lie flat and not be folded.
5. Reattach the cuff connector [Cuff connector] to the cuff tubing [Cuff tubing].

Do not use fabric softener. ⚠️ WARNING: Never wash the cuff in a washing machine or dishwasher!

⚠️ WARNING: Do not dry the cuff in a tumble dryer or on a heater!

⚠️ WARNING: Never wash the inner inflatable part!

Accuracy Test

It is recommended to have the device tested for accuracy every 2 years or after a mechanical shock (e.g., a fall). Please contact your Microlife importer for a general function check.

Disposal

Batteries and electronic instruments must be disposed of according to local regulations and not with household waste.

Warranty

This device comes with a 5-year warranty from the date of purchase. During this period, Microlife will repair or replace defective products free of charge. Opening or modifying the device will void the warranty. The warranty excludes: transport costs and risks, damage from incorrect use or non-compliance with instructions, damage from leaking batteries, damage from drops or misuse, packaging/storage materials and manuals, regular checks and maintenance (calibration), and accessories/consumables (batteries, optional power adapter). The cuff bladder is covered by a functional warranty (tightness) for 2 years. For warranty service, contact the dealer where you purchased the product or Microlife's service department via www.microlife.nl/support. Compensation is limited to the product's value. The warranty is valid upon return of the complete product with the original invoice. Repairs or replacements do not extend the warranty period. Statutory consumer rights are not affected by this warranty.

Technical Specifications

• Operating Conditions: 10 - 40 °C / 50 - 104 °F; 15 - 90% maximum relative humidity.
• Storage Conditions: -20 - +55 °C / -4 - +131 °F; 15 - 90% maximum relative humidity.
• Weight: 277 g (including batteries).
• Dimensions: 131 x 90 x 60.5 mm.
• Cuff Dimensions: 17 - 52 cm.
• Measurement Procedure: Oscillometric, according to the Korotkoff method: Phase I systolic, Phase V diastolic.
• Measurement Range: SYS: 60 - 255 mmHg; DIA: 40 - 200 mmHg; Pulse: 40 - 199 beats per minute.
• Cuff Pressure Display Range: 0 - 299 mmHg.
• Resolution: 1 mmHg.
• Static Accuracy: ±3 mmHg.
• Pulse Accuracy: ±5% of the displayed value.
• Power Source: 4 x 1.5V alkaline batteries (type AA); DC 6V, 600 mA AC adapter (optional).
• Battery Life: Approximately 920 measurements (with new batteries).
• IP Class: IP 20.
• Reference to Standards: IEC 80601-2-30; IEC 60601-1; IEC 60601-1-2 (EMC); IEC 60601-1-11.
• Expected Lifespan: Device: 5 years or 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 modifications reserved.