medisana BU 540 connect Blood Pressure Monitor

Intended Use

This fully automatic electronic blood pressure monitor is intended for measuring blood pressure at home. It is a non-invasive system for measuring systolic and diastolic blood pressure and pulse in adults using oscillometric technique with an upper arm cuff. The usable cuff circumference is 22 to 42 cm. It is intended for adult indoor use only.

Contraindications

The device is not suitable for measuring blood pressure in children. Consult your doctor before using it on older children. The device is not suitable for use on pregnant women and patients with implanted electronic devices (e.g., pacemakers or defibrillators).

Explanation of Symbols

IMPORTANT: Follow the instructions for use! Non-observance can result in serious injury or damage to the device.

WARNING: These warning notes must be observed to prevent any injury to the user.

CAUTION: These notes must be observed to prevent any damage to the device.

NOTE: These notes give you useful additional information on installation or operation.

Device Classification

Type BF applied part

LOT number: [LOT-number]

SN: Serial number

Manufacturer: medisana GmbH

Date of manufacture: [Date]

Certification Mark: CE 0297

Common Factors for Wrong Measurements

• Rest for 5-10 minutes before measurement; avoid eating, drinking alcohol, smoking, exercising, or bathing.
• Remove any garment that fits closely to your upper arm.
• Always measure on the same arm (normally the left).
• Measure regularly at the same time of day, as blood pressure varies.
• Avoid supporting the arm during measurement, as this may increase blood pressure.
• Ensure a comfortable, relaxed position and do not tense muscles during measurement. Use a cushion if necessary.
• Ensure the arm artery is at heart level; positioning it lower or higher will lead to false readings.
• A loose or open cuff causes false readings.
• Repeated measurements can cause blood to accumulate in the arm, leading to false readings. Allow 3-minute pauses between consecutive measurements or hold the arm up to allow blood to flow away.

Safety Instructions

Read the manual carefully, especially safety instructions, and keep it for future use. Pass on instructions if the device is given to others.

• Intended for private use in-home only.
• Allow the device to acclimatize to room temperature for approx. 30 minutes before use.
• Consult your doctor if you have health concerns before using the monitor.
• Use only for its intended purpose according to instructions. Misuse voids warranty.
• Do not use to check pacemaker heart rate.
• Arrhythmia can lead to difficulties in recording correct readings; the device detects this and indicates it with symbol z. Contact your doctor if detected.
• Do not use if allergic to polyester or synthetic materials.
• Certain medical conditions (cardiac arrhythmias, low blood pressure, circulatory disorders, shock, diabetes, pregnancy, pre-eclampsia) can affect accuracy. Consult a doctor before use.
• Never apply the cuff over hurt skin.
• Do not take measurements if other equipment is applied to the same limb.
• If discomfort (pain, etc.) occurs during measurement, press START/STOP 8 to release air immediately. Loosen and remove the cuff.
• In rare cases of malfunction causing the cuff to remain inflated, open it immediately. Prolonged high pressure (>300 mmHg or >15 mmHg for >3 min) can cause ecchymosis.
• Too frequent measurements can disturb blood circulation and cause injuries.
• Ensure cables and air hose do not pose a strangulation hazard during use and storage.
• Never bend or block the air hose.
• Do not connect the air hose to other medical equipment to avoid air entering intravascular systems or causing high pressure.
• Not suitable for continuous monitoring during medical emergencies or operations.
• Not for patient transport outside a healthcare facility.
• Not for use with surgical equipment.
• Do not take therapeutic measures based on self-measurement. Never alter medication dosage.
• Do not operate near strong electric radiation sources (radios, mobile phones) as this may affect function.
• Do not use near flammable anesthetic gas mixtures.
• Not designed for use by persons with limited physical, sensory, or mental abilities, or lack of experience/knowledge, unless supervised or instructed.
• Intended for adults only. Not for infants or children. Consult a doctor for use on adolescents.
• Keep away from children and pets. Small parts can cause suffocation.
• Ensure the device functions safely and is in proper working condition before use. Do not service while in use.
• Do not attempt self-repair. Repairs must be carried out by authorized service centers.
• Protect from moisture. If moisture enters, remove batteries and stop use. Contact dealer or medisana.
• Use only original parts.
• Report unexpected operations or events to medisana.
• Remove batteries if the unit will not be used for a long period.

Battery Safety Information

• Do not disassemble batteries.
• Replace batteries when the low battery icon u appears.
• Remove discharged batteries promptly to prevent leakage and damage.
• Avoid contact with skin, eyes, and mucous membranes. If contact occurs, rinse with water and seek medical attention.
• If a battery is swallowed, seek medical attention immediately.
• Replace all batteries simultaneously.
• Use only batteries of the same type; do not mix types or new/used batteries.
• Insert batteries correctly, observing polarity.
• Keep batteries out of children's reach.
• Do not recharge, short-circuit, or throw batteries into fire (risk of explosion).
• Dispose of used batteries properly at collection points, not in household waste.

Scope of Supply

Please check that the unit is complete:

• 1 medisana Blood Pressure Monitor BU 540 connect
• 1 Cuff with air tube
• 4 Batteries (type AAA, LR03) 1.5 V
• 1 Instruction manual and EMV leaflet

Contact your supplier if you notice any transport damage.

How is Blood Pressure Measured?

This medisana blood pressure monitor measures blood pressure on the upper arm using a microprocessor during cuff inflation. It detects systole earlier and completes measurement faster than conventional methods, preventing unnecessarily high cuff pressure. The device also recognizes irregular heartbeats (arrhythmia), indicated by symbol z.

Blood Pressure Classification

Blood pressure that is too low also represents a health risk! Dizziness may lead to dangerous situations (e.g., on stairs or in traffic).

Influencing and Evaluating Readings

• Measure several times, record, and compare results. Do not draw conclusions from a single reading.
• Have readings evaluated by a doctor familiar with your medical history. Inform your doctor of the progress periodically.
• Daily values are influenced by factors like smoking, alcohol, medication, and physical exertion.
• Measure before meals.
• Rest for at least 5-10 minutes before measuring.
• If readings seem unusual (too high or too low) despite correct use, inform your doctor. This also applies if an irregular or weak pulse prevents measurements.

Getting Started

Inserting/Changing Batteries

Open the battery compartment 3 on the underside of the unit. Insert the 4 x 1.5 V batteries (type AAA / LR03), observing polarity. Replace batteries when the low battery symbol u appears or if the display is blank after switching on.

Settings

1. Date and Time

With the unit off, press SET 7. The time displays. Press and hold SET 7 until the year flashes. Use MEM 6 to set the year, then press SET 7 to confirm. Proceed to set month, day, time format (12/24 hr), hours, and minutes. Press SET 7 to confirm each. The display shows "dOnE" and the settings, then the unit turns off.

2. User Memory Setting

The device offers 2 separate memories, each with 250 slots. Press the user memory button 5 when the device is on to select between user o (A/B).

Fitting the Cuff

1. Connect the air hose to connector 1 on the left side of the device.
2. Slide the open end of the cuff through the metal bracket so the Velcro fastener is outside, forming a cylinder (See Fig. 1: Diagram showing how to thread the cuff through the metal bracket). Slide the cuff over your left upper arm.
3. Position the air hose in the middle of the arm, aligned with the middle finger (See Fig. 2: Diagram showing correct cuff placement and air hose alignment). The lower edge of the cuff should be 2-3 cm above the elbow crease. Tighten the cuff and close the Velcro fastener.
4. Measure on a bare arm.
5. If the cuff cannot be used on the left arm, use the right arm. Always measure on the same arm.
6. Ensure correct measuring position while sitting (See Fig. 3: Diagram showing correct sitting position for measurement).

Taking a Blood Pressure Measurement

1. Turn the unit on by pressing START/STOP 8.
2. All display characters appear briefly (display test). The unit is ready for measurement, showing "0".
3. The device automatically inflates the cuff slowly. The rising pressure is shown on the display.
4. When a signal is detected, the pulse symbol t flashes. After a result is determined, the device slowly deflates the cuff and displays systolic and diastolic pressure, pulse rate, and time.
5. The blood pressure indicator p flashes next to the relevant colored bar according to the blood pressure classification.
6. If an irregular heartbeat is detected, the arrhythmia display z appears additionally.
7. Readings are automatically saved in the selected memory (o).
8. Measurement results are automatically transferred via Bluetooth to receiving devices, indicated by the flashing Bluetooth symbol r. A successful transfer makes the r symbol disappear after approx. 5 seconds. An unsuccessful transfer makes it disappear after max. 3 minutes.
9. Turn off the device using the START/STOP button 8.

Transfer via Bluetooth

The medisana BU 540 connect allows data transfer via Bluetooth to the VitaDock app. VitaDock enables detailed evaluation, storage, and synchronization of data across multiple iOS and Android devices. Create a free account at www.vitadock.com. Download the respective apps for mobile devices. Automatic data transfer occurs after each measurement if Bluetooth is enabled on the receiving device.

Keep the device at least 20 cm away from your body (especially the head) during Bluetooth data transmission.

The distance between the device and receiver should be between 1 and 10 meters to avoid interference. Keep other electronic devices at least 1 meter away.

Displaying Stored Results

The unit has 2 memories, each with 250 slots. Results are automatically stored in the selected memory. Press MEM 6 when the unit is off to recall stored values. The average of the last 3 measurements appears first (if at least 3 are stored). Press MEM 6 again to see the last measurement, and repeatedly to scroll through previous ones. Press START/STOP 8 to exit memory recall mode and turn off the unit. When memory is full (250 values), the oldest value is deleted upon saving a new one.

Deleting Memory

Enter memory recall mode by pressing MEM 6. To permanently delete all stored values, press and hold SET 7 for approx. 3 seconds until "dEL ALL" appears. Press SET 7 again to delete. The device turns off automatically. You can cancel deletion by pressing START/STOP 8 beforehand.

Error Messages and Remedying

If a problem cannot be solved, contact the service center. Do not disassemble the unit yourself.

Cleaning and Maintenance

Remove batteries before cleaning. Clean the unit and cuff with a soft cloth lightly moistened with a mild soapy solution. Never use abrasive cleaners, alcohol, thinner, or gasoline. Do not immerse the unit or any component in water. Be cautious not to get moisture into the main unit. Do not wet the cuff or attempt to clean it with water; wipe it dry with a cloth and allow it to air dry flat. Protect from direct sunlight, dirt, moisture, extreme heat, and cold. Store in the provided case when not in use. Store in a clean and dry location.

Disposal

This product must not be disposed of with domestic waste. All users must hand in electrical or electronic devices at municipal or commercial collection points for environmentally sound disposal. Remove batteries before disposal. Do not dispose of old batteries in household waste; take them to a hazardous waste container or battery collection point. Consult local authorities or your supplier for disposal information.

Guidelines / Standards

This blood pressure monitor meets EU standards for non-invasive blood pressure monitors. It is CE certified (CE 0297) and complies with European standards EN 60601-1, EN 60601-1-2, EN 1060-3, EN 81060-1, and EN 81060-2. It meets EU Directive 93/42/EEC and RED 2014/53/EC. The full Declaration of Conformity can be requested from or downloaded from medisana GmbH, Carl-Schurz-Str. 2, 41460 Neuss, Germany, or from the medisana homepage (www.medisana.com).

Electromagnetic compatibility: (see attached leaflet)

Technical Specifications

In accordance with the policy of continual product improvement, technical and design changes may be made without notice.

Warranty and Repair Terms

Contact your supplier or the service center for warranty claims. If returning the unit, state the defect and enclose a copy of the receipt.

1. medisana products have a 3-year warranty from the date of purchase, proven by sales receipt or invoice.
2. Defects in material or workmanship will be repaired free of charge within the warranty period.
3. Warranty repairs do not extend the warranty period for the unit or replacement parts.
4. Warranty excludes: a. Damage from improper treatment or non-observance of instructions. b. Damage from repairs or tampering by the customer or unauthorized third parties. c. Transport damage. d. Accessories subject to normal wear and tear.
5. Liability for direct or indirect consequential losses caused by the unit is excluded, even if damage to the unit is accepted as a warranty claim.