medisana BU 540 connect Blood Pressure Monitor

Introduction

This document provides instructions for the 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 via 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 a doctor before using on older children.
• The device is not suitable for use on pregnant women and patients with implanted electronic devices (e.g., pacemaker or defibrillator).

Explanation of Symbols

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

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

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

NOTE: These notes provide useful additional information.

Device Classification: Type BF applied part

LOT number: [LOT Number]

SN: Serial number

Manufacturer: [Manufacturer Name]

Date of manufacture: [Date]

CE 0297: Conformity mark

Common Factors Causing Incorrect Measurements

• Rest for 5-10 minutes before measuring; avoid eating, drinking alcohol, smoking, exercising, or bathing.
• Remove tight clothing from the upper arm.
• Always measure on the same arm (usually left).
• Measure at the same time each day for consistency.
• Supporting the arm can increase blood pressure readings.
• Maintain a comfortable, relaxed position; do not tense arm muscles. Use a cushion if needed.
• Arm artery position relative to the heart affects readings.
• A loose or open cuff leads to false readings.
• Repeated measurements can cause blood accumulation, leading to false readings. Allow 3-minute pauses between measurements or hold the arm up to allow blood flow.

Safety Instructions

• For private, indoor use only.
• Allow the device to acclimatize to room temperature for approx. 30 minutes before use.
• Consult a doctor if you have health concerns.
• Use only for its intended purpose.
• Warranty is void if misused.
• Do not use to check pacemaker heart rate.
• Irregular pulse or arrhythmia can affect readings; the device indicates this 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.
• Never apply the cuff over broken skin.
• Do not take measurements if other equipment is monitoring the same limb.
• If discomfort occurs (pain, etc.), press START/STOP 8 to deflate the cuff immediately.
• In rare cases of malfunction, if the cuff remains inflated, open it immediately. Prolonged high pressure can cause bruising.
• Frequent measurements can disturb blood circulation and cause injury.
• Ensure cables and hoses do not pose a strangulation hazard.
• Never bend or block the air hose.
• Do not connect the air hose to other medical equipment.
• Not suitable for continuous monitoring during emergencies or operations.
• Not for use during patient transport outside a healthcare facility.
• Not for use with surgical equipment.
• Do not take therapeutic measures based on self-measurement. Never alter prescribed medication doses.
• Do not operate near strong electrical radiation sources (radios, mobile phones) as it may affect function.
• Do not use near flammable anesthetic gas mixtures.
• Not for use by persons with limited physical, sensory, or mental abilities, or lack of experience, 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 is in proper working condition before use. Do not service while in use.
• Do not attempt self-repair; contact authorized service centers.
• Protect from moisture. If liquid enters, remove batteries and stop use. Contact dealer or medisana.
• Use only original parts.
• Report unexpected operations or events to medisana.
• Remove batteries if not using for a long period.

Battery Safety Information

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

Device and LCD Display

The device includes:

• 1 Connector for air hose
• 2 Air hose
• 3 Battery compartment (on backside)
• 4 Cuff
• 5 User memory button
• 6 MEM button (Memory)
• 7 SET button (Setting)
• 8 START/STOP button
• 9 LC display
• 0 Display of systolic pressure
• q Display of diastolic pressure
• w Display of pulse rate
• e Time / Date
• r Bluetooth symbol
• t Inflation / Deflation symbol
• z Pulse / Arrhythmia display
• u Batteries low indicator
• i Average value display ("AVG")
• o User memory indicator (A/B)
• p Blood Pressure Indicator (color-coded: green, yellow, orange, red)
• a Memory display

Scope of Supply

Please check that the unit is complete. Included:

• 1 medisana blood pressure monitor BU 540 connect
• 1 cuff with air tube
• 4 batteries (type AAA, LR03) 1.5 V
• 1 storage pouch
• 1 instruction manual and EMV leaflet

Contact your supplier immediately if you notice any transport damage.

How Blood Pressure is Measured

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

Blood Pressure Classification

WARNING: Blood pressure that is too low is also a health risk. Dizziness can lead to dangerous situations.

Influencing and Evaluating Readings

• Take multiple measurements, record, and compare results. Do not draw conclusions from a single reading.
• Always have readings evaluated by a doctor familiar with your medical history. Inform your doctor 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 are consistently unusual (too high/low) despite correct use, inform your doctor. This also applies if an irregular or weak pulse prevents measurement.

Getting Started

Inserting/Changing Batteries

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

Settings

1. Date and Time

With the device off, press SET (7). The time displays. Press and hold SET (7) until the year flashes. Press MEM (6) to select the year, then SET (7) to confirm. Proceed to set month, day, time format (12/24 hr), hours, and minutes. "dOnE" appears upon completion, and the device turns off.

2. User Memory Setting

The device has 2 memory banks, each storing 250 values. Press the user memory button (5) when the device is on to switch between User A and User B (indicated by o).

Fitting the Cuff

1. Connect the air hose to the connector (1) on the device.
2. Thread the open end of the cuff through the metal bracket, ensuring the Velcro is on the outside to form a cylinder (Fig. 1). Slide the cuff over your left upper arm.
3. Position the air hose in the middle of the arm, aligned with the middle finger (Fig. 2a). The cuff's lower edge should be 2-3 cm above the elbow crease (Fig. 2b). Tighten the cuff and secure with Velcro (Fig. 2c).
4. Measure on a bare arm.
5. If the left arm is unsuitable, use the right arm. Always measure on the same arm.
6. Correct sitting position for measurement (Fig. 3).

Taking a Blood Pressure Measurement

1. Switch on by pressing START/STOP (8).
2. All display characters appear briefly (display test). The device is ready, and "0" is shown.
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 starts flashing. Once a result is determined, the cuff deflates slowly. Systolic, diastolic pressure, pulse rate, and time are displayed.
5. The blood pressure indicator (p) flashes next to the corresponding color bar based on classification.
6. If an irregular heartbeat is detected, the arrhythmia display (z) appears.
7. Readings are automatically saved in the selected user memory (o).
8. Results are automatically transferred via Bluetooth to compatible devices (indicated by flashing Bluetooth symbol r). The symbol disappears after successful transfer (approx. 5 seconds) or after 3 minutes if unsuccessful.
9. Switch off by pressing START/STOP (8).

Bluetooth Transfer

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

WARNING:

• Keep the device at least 20 cm away from the body (especially the head) during Bluetooth transmission.
• Maintain a distance of 1-10 meters between the device and the receiver.
• Keep other electronic devices at least 1 meter away to avoid interference.

Displaying Stored Results

The device has 2 memory banks, each with 250 slots. Press MEM (6) when the device is off to recall stored values. The average of the last 3 measurements is shown first (if available). Repeatedly pressing MEM (6) cycles through previous measurements. Press START/STOP (8) to exit memory recall and turn off the device. If 250 values are stored, the oldest is deleted when a new one is saved.

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 confirm deletion. The device turns off. Press START/STOP (8) to cancel deletion.

Error Messages and Error 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 mild soapy water. Never use abrasive cleaners, alcohol, thinner, etc. Do not immerse the unit or components in water. Ensure no moisture enters the unit. Allow the cuff to air dry completely. Do not expose to direct sunlight, dirt, moisture, extreme heat, or cold. Store in the pouch when not in use. Keep in a clean, dry place.

Disposal

Do not dispose of this device with household waste. Users must hand in electrical/electronic devices at municipal or commercial collection points for environmentally sound disposal. Remove batteries before disposal. Dispose of used batteries properly (hazardous waste or collection points). Contact local authorities or your retailer 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 medisana GmbH or downloaded from www.medisana.de.

Electromagnetic compatibility: (see attached leaflet)

Technical Specifications

• Name and description: medisana Blood pressure monitor BU 540 connect
• Display system: Digital display
• Memory slots: 2 x 250 measurement values
• Measuring method: Oscillometric
• Power supply: 6 V , 4 x 1.5 V batteries AAA LR03
• Blood pressure measuring range: 0 – 299 mmHg
• Pulse measuring range: 40 – 199 beats/min.
• Maximum error tolerance for static pressure: ± 3 mmHg
• Maximum error tolerance for pulse rate: ± 5 % of the value
• Pressure generation: Automatic with pump
• Deflation: Automatic
• Protection marking against particles and water: IP21
• Operating conditions: +5 °C to +40 °C, 15 to 90 % max. relative humidity, 700-1060 hPa atmospheric pressure
• Storage conditions: -20 °C to +60 °C, up to 93 % max. relative humidity, non-condensing
• Dimensions (L x W x H): approx. 140 x 130 x 49.7 mm
• Cuff: 22 - 42 cm for adults
• Weight (main unit): approx. 230 g without batteries
• Item number: 51182
• EAN number: 40 15588 51182 0
• Accessories: Spare cuff Art. No. 51299 / EAN 40 15588 51299 5

Technical and design changes are reserved in accordance with our policy of continuous product improvement.

The current version of this instruction manual can be found at www.medisana.com.

Warranty and Repair Terms

Contact your dealer or the service center for warranty claims. If returning the unit, state the defect and enclose a copy of the purchase receipt. The following warranty terms apply:

1. medisana products have a 3-year warranty from the date of purchase, proven by receipt or invoice.
2. Material or manufacturing defects will be repaired free of charge within the warranty period.
3. Warranty service does not extend the warranty period for the unit or replacement parts.
4. Warranty excludes:
   • Damage due to improper use or non-observance of instructions.
   • Damage due to repairs or tampering by the customer or unauthorized third parties.
   • Transport damage.
   • 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.

The service center address is on the attached leaflet.