medisana BU 535 Voice Blood Pressure Monitor

Introduction

This document is the instruction manual for the medisana BU 535 Voice upper arm blood pressure monitor. It provides detailed information on safe and correct usage, setup, measurement procedures, and maintenance.

Safety Instructions

Important: Read the instruction manual carefully, especially the safety instructions, before using the device. Keep the manual for future reference. Ensure it is passed on if the device is given to another person.

General Warnings:

• The device is intended for home use only. Consult a doctor for health concerns.
• Use the device only for its intended purpose. Misuse voids the warranty.
• Consult a doctor if you have conditions like arterial occlusive disease.
• Do not use for checking pacemaker heart rate.
• Certain medical conditions (arrhythmias, low blood pressure, shock, diabetes, pregnancy, pre-eclampsia) can affect accuracy. Consult a doctor before use.
• The device is not for medical diagnosis; readings are for reference only.
• Arrhythmia detection is not a substitute for professional cardiac examination.
• Irregular pulse or arrhythmia may cause measurement difficulties; the device indicates this with a symbol. Contact your doctor if detected.
• Consult your doctor about individual risks of cuff pressure.
• Discomfort during measurement (pain, continuous inflation) requires immediate interruption by pressing the START/STOP button.
• Frequent measurements can lead to side effects like nerve compression or blood clots.
• Measurements may cause temporary skin marks.
• Not for use by persons with limited physical, sensory, or mental abilities unless supervised or instructed.
• Intended for adults; not for infants or children. Consult a doctor for use on adolescents.
• Keep away from children; medical products are not toys.
• Swallowing small parts can cause suffocation.
• Ensure the device functions properly before use.
• Use only under specified ambient conditions for accuracy.
• Do not use in moving vehicles.
• Do not use near flammable gases or liquids.
• Consult your doctor if the cuff needs to be applied over injuries, burns, on limbs with catheters/shunts, on the side of a mastectomy, or if other measurements are taken simultaneously on the same body part.
• Do not use other cuffs or use with multiple people to avoid infections.
• Apply cuff only to the left upper arm; use the right arm only if the left is not possible. Always measure on the same arm.
• Do not apply cuff over clothing.
• Do not kink, fold, or pull the cuff over sharp edges.
• Do not modify or disassemble the device.
• Avoid high temperatures and direct sunlight.
• Protect from moisture. Remove batteries immediately if liquid penetrates.
• Do not attempt self-repair; use authorized service centers.
• Allow device to acclimatize to room temperature if stored in cool conditions.
• Avoid heavy impacts and drops.
• Do not insert objects into openings or force buttons.
• Remove batteries if not used for a long period.

Battery Safety Instructions:

• Do not disassemble batteries.
• Replace batteries when the battery symbol appears.
• Remove weak batteries promptly to prevent leakage and damage.
• Avoid contact with skin, eyes, and mucous membranes. Rinse affected areas with water and seek medical attention if contact occurs.
• Seek immediate medical attention if a battery is swallowed.
• Replace all batteries simultaneously with the same type.
• Do not mix old and new or different battery types.
• 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/collection points).

Device Overview and Components

Device Components:

• Upper arm cuff with air tube
• Main unit with LCD display
• START/STOP button
• Memory Recall (M) button
• Battery compartment (underside)
• Push-in connector for air tube

Display Indicators:

• LCD display showing systolic pressure, diastolic pressure, and pulse rate.
• Blood Pressure Indicator (color-coded: red, orange, yellow, green).
• Pulse symbol (flashes during measurement).
• Symbol for zero pressure search.
• Memory location number.
• M symbol (memory).
• Change Battery symbol.
• User memory indicator.
• Irregular heartbeat indicator.

Scope of Supply:

• 1 medisana Blood pressure monitor BU 535 Voice
• 4 batteries (type AAA, LR03) 1.5V
• 1 cuff with air tube
• 1 storage pouch
• 1 instruction manual

Getting Started

Inserting/Replacing Batteries

Open the battery compartment on the underside, insert 4 x 1.5V AAA LR03 batteries, observing polarity. Close the compartment. Replace batteries when the battery change symbol appears or the display is blank.

Settings: Display Format, Date, Time

Set time and date for correct operation. The device enters setting mode for 1 minute after battery insertion. To re-enter setting mode, press and hold the START/STOP and M buttons simultaneously for approx. 2 seconds. Adjust clock format (12/24 hr), year, month, day, hour, and minute using the M button to change values and the START/STOP button to confirm and proceed. Settings are lost upon battery replacement.

Setting the Voice Language

The BU 535 Voice has a voice output function. With the device off, press and hold the M button. Select language (1=German, 2=English, 3=Dutch, 4=French, 5=Italian, 6=Turkish) by holding the button until the desired language is displayed. Release the button. The M button can also be used to adjust volume.

How to Measure Blood Pressure

Fitting the Cuff

1. Insert the air tube end piece into the device's left-side opening.
2. Slide the open end of the cuff through the metal bracket, ensuring the Velcro fastener is on the outside to form a cylinder.
3. Slide the cuff over your left upper arm.
4. Position the air hose in the middle of the arm, aligned with the middle finger (a). The lower edge of the cuff should be 1-2 cm above the elbow crease (b).
5. Tighten the cuff and close the Velcro fastener (c).
6. Measure on a bare arm.
7. Use the right arm only if the left arm cannot be used. Always measure on the same arm.
8. Ensure a correct measuring position while sitting (Fig. 3).

Taking a Measurement

1. Switch on the device by pressing the START/STOP button. All symbols will briefly appear on the display.
2. Select user memory (1 or 2) by pressing the M button. If no selection is made within 5 seconds, the measurement is assigned to the currently displayed user.
3. The last measured value for the selected user is shown (or '0' if none). The device then deflates the cuff completely (zero pressure search symbol appears).
4. The device is ready. It automatically inflates the cuff slowly. The rising pressure is shown on the display.
5. Inflation continues until sufficient pressure is reached. The device then slowly deflates the cuff and performs the measurement.
6. When a signal is detected, the pulse symbol flashes. A beep sounds with each detected pulse.
7. After measurement, the cuff deflates completely. Systolic and diastolic pressure, and pulse rate appear on the display.
8. The Blood Pressure Indicator shows the classification next to the corresponding colored bar. An irregular heartbeat is indicated by a separate symbol.
9. Measured values are automatically saved in the selected memory (up to 120 values with date/time per memory).
10. Results remain on display for about 1 minute or until the device is switched off using the START/STOP button.

Discontinuing a Measurement

Press the START/STOP button at any time to interrupt the measurement. The cuff will deflate automatically.

Memory Functions

Display Stored Values

The device has 2 memories, each with 120 slots. To recall stored values, press the M button when the device is off. A user memory (1 or 2) and the number of saved values are shown. Use the START/STOP button to switch between user memories. Press M again to see averages of the last 3 measurements (A3), then overall average (AL), average of last 7 days (morning AM, evening PM). Subsequent M presses show previous measurements. '0' is displayed if no values are saved.

Delete Saved Values

To delete a user's saved values, display any value for that user, then press and hold the M button for approx. 3 seconds. 'CL' and '00' will appear, indicating deletion.

Troubleshooting

Error Messages:

If problems persist, contact the manufacturer. Do not disassemble the unit.

Cleaning and Care

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, or gasoline. Do not immerse in water. Ensure no moisture enters the unit. Dry thoroughly before reuse. Only inflate cuff when on the arm. Protect from direct sunlight, dirt, moisture, extreme temperatures. Store in original packaging in a clean, dry place.

Servicing and Calibration

The unit is calibrated by the manufacturer for two years. Commercial use requires recalibration at least every two years (fee applies). The device is designed for at least 10,000 measurements or three years of safe use. Cuff integrity is maintained after 1,000 open/close cycles.

Disposal

Do not dispose of with domestic waste. Hand in electrical/electronic devices at municipal or commercial collection points for environmentally sound disposal. Remove batteries before disposal. Dispose of used batteries separately or at collection points.

Guidelines and Standards

The blood pressure monitor complies with EU standards for non-invasive blood pressure monitors and is CE certified (CE 0297). It meets EU Guideline 93/42/EEC and European standards EN 60601-1, EN 80601-2-30, EN 1060-1, EN 1060-3. It also complies with electromagnetic compatibility standards EN60601-1-2.

Technical Specifications

Warranty and Repair Terms

A 3-year warranty is provided from the date of purchase, requiring proof of purchase. Defects due to material or workmanship are covered. Warranty does not extend the warranty period. Exclusions include damage from improper use, unauthorized repairs, transport damage, and normal wear and tear (e.g., batteries). Liability for consequential damages is excluded.

Contact your specialist dealer or the service center for warranty claims. If returning the unit, include a copy of the receipt and a description of the defect.

Manufacturer Contact:

medisana GmbH, Carl-Schurz-Str. 2, 41460 NEUSS, GERMANY.
E-mail: info@medisana.de, Internet: www.medisana.com

Blood Pressure Classification

The device classifies blood pressure readings into categories:

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

Influencing and Evaluating Readings

• Measure multiple times, 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 about the readings.
• Note that daily values depend on factors like tobacco, alcohol, medication, and physical activity.
• If readings are consistently unusual (too high or too low) despite correct use, consult your doctor.