medisana BU 516 Upper Arm Blood Pressure Monitor

Intended Use

The device is intended for measuring the arterial blood pressure on the upper arm of adults.

Contraindications

• The device is not intended for measuring blood pressure in children. Consult a doctor for use on older children.
• Individuals with arrhythmia, diabetes, circulatory disorders, or those who have suffered a stroke should use the device as recommended by their doctor.

Explanation of Symbols

IMPORTANT: Follow the instructions! Failure to comply with this user manual may lead to serious injury or damage to the device.

WARNING: Read these warnings to avoid potential injuries.

CAUTION: Read these warnings to avoid potential damage to the device.

TIP: These tips also contain useful information for installation and use.

Device Classification: Type BF

LOT Number: [LOT Number]

Manufacturer: medisana GmbH

Date of Manufacture: [Date]

Protection: IP21

Common Causes of Incorrect Measurements

• Rest for 5-10 minutes before measurement; refrain from eating, drinking alcohol, smoking, physical exertion, sports, and bathing. These factors can affect the measurement.
• Remove clothing that is too tight around the upper arm.
• Always measure on the same arm (usually the left).
• Blood pressure should be measured regularly, daily at the same time, as it changes throughout the day.
• Any attempt by the patient to support the arm can increase blood pressure.
• Assume a comfortable, relaxed position. Do not tense the arm being measured. Use a cushion if necessary.
• If the brachial artery is below or above heart level, the measurement will be incorrect.
• A loose or improperly fastened cuff causes incorrect measurements.
• Repeated measurements can cause blood to accumulate in the arm, leading to incorrect results. Allow a 1-minute break between measurements or raise the arm to allow blood to drain.

Safety Instructions

Read the user manual carefully before using the device, especially the safety instructions, and keep it for future reference. When passing the device to third parties, include this user manual.

• The device is intended for private use only. Consult a doctor for any health complaints.
• Use the device only as intended, following the user manual. Misuse voids all warranty claims.
• If you have conditions like arterial occlusion, consult your doctor before use.
• The device must not be used to control the heart rate of a pacemaker.
• Pregnant women should take necessary precautions to avoid overexertion; consult a doctor if needed.
• If unpleasant symptoms occur, such as arm pain, use the START/STOP button to immediately deflate the cuff. Loosen and remove the cuff.
• The device functions correctly only with an appropriately sized cuff.
• The device is not intended for children. Children must not use this device. Medical products are not toys!
• Keep the device out of reach of children.
• Do not wrap the air hose around the neck due to the risk of strangulation.
• Swallowing small parts (packaging material, batteries, battery compartment cover) can lead to suffocation.
• Users must ensure the device is operating safely and correctly before use.
• Use only the supplied cuff. Do not replace it with a different type; only use the same type of cuff.
• Do not use the device in areas with strong electromagnetic fields or near devices emitting electromagnetic waves (e.g., radio transmitters, mobile phones, microwave ovens). This could cause interference or incorrect readings.
• Do not use the device near flammable gases (e.g., anesthetic gas, oxygen, hydrogen) or flammable liquids (e.g., alcohol).
• Do not modify the device.
• Never attempt to repair the device yourself. Repairs must be carried out by authorized service centers.
• Protect the device from moisture. If liquid enters the device, immediately remove batteries and discontinue use. Contact the retailer or medisana.
• Do not use solvents, alcohol, or gasoline for cleaning.
• Protect the device from strong impacts and drops.
• Remove batteries if the device will not be used for an extended period.

Battery Safety Instructions

• Do not disassemble batteries!
• Replace batteries when the battery symbol appears on the display.
• Remove weak batteries promptly to prevent leakage and damage to the device.
• Risk of electrolyte leakage; avoid contact with skin, eyes, and mucous membranes. If contact occurs, rinse with plenty of clean water and seek medical attention immediately.
• If a battery is swallowed, seek medical attention immediately.
• Always replace all batteries simultaneously.
• Use only batteries of the same type; never mix different types or used and new batteries.
• Ensure correct polarity when inserting batteries.
• Remove batteries if the device will not be used for at least 3 months.
• Keep batteries away from children.
• Do not recharge non-rechargeable batteries (risk of explosion).
• Do not short-circuit batteries (risk of explosion).
• Do not dispose of batteries in fire (risk of explosion).
• Dispose of used batteries as special waste or at a battery collection point, not in household waste.

Device and LCD Display

Components:

• 1. Upper arm blood pressure monitor
• 2. Battery compartment cover
• 3. MEM button (memory)
• 4. START/STOP button
• 5. SET button
• 6. Battery compartment (underside)
• 7. Air hose connector
• 8. LCD display
• 9. Date/Time indicator
• 0. Systolic blood pressure indicator
• q. Diastolic blood pressure indicator
• w. Pulse symbol
• e. Heart rate indicator
• r. Battery replacement symbol
• t. Irregular heart rhythm symbol
• z. Memory slot number
• u. Memory symbol and blood pressure indicator (green - yellow - orange - red)
• o. User memory 1 / 2

Scope of Delivery

Check the contents upon unpacking. The scope of delivery includes:

• 1 medisana BU 516 upper arm blood pressure monitor
• 1 cuff with air hose
• 4 batteries (type AA, LR6) 1.5 V
• 1 storage bag
• 1 user manual

If you discover transport damage after unpacking, contact the retailer immediately.

What is Blood Pressure?

Blood pressure is the pressure exerted on the vessel walls with each heartbeat. When the heart contracts (= systole) and pumps blood into the arteries, pressure increases. The highest value is called systolic pressure, measured first. When the heart muscle relaxes to receive new blood, arterial pressure drops. The second value, measured when vessels are relaxed, is diastolic pressure.

How Measurement Works

The medisana BU 516 is an upper arm blood pressure monitor. Measurement is performed by a microprocessor that interprets vibrations on the artery via a pressure sensor as air is pumped into and released from the cuff.

Blood Pressure Classification

WARNING: Low blood pressure is as risky as high blood pressure! Dizziness can lead to dangerous situations (e.g., on stairs or in traffic).

Measurement and Evaluation

• Take multiple measurements, save them, and compare. Do not draw conclusions from a single measurement.
• Blood pressure values should always be evaluated by a doctor familiar with your medical history. Inform your doctor periodically about your measurement progress.
• Daily blood pressure values depend on many factors. Smoking, alcohol, medication, and physical activity influence measurements.
• Measure blood pressure before meals.
• Rest for at least 5-10 minutes before measuring.
• If systolic or diastolic values appear consistently abnormal (too high or too low) despite proper device function, inform your doctor. This also applies if an irregular or weak pulse prevents measurement.

Getting Started

Inserting / Replacing Batteries

Insert the included batteries to operate the device. Open the battery compartment cover (6) on the underside of the device. Insert 4 x 1.5 V AA LR6 batteries, observing correct polarity. Close the compartment. Replace batteries when the battery symbol (r) appears or when no indicators are shown after switching on.

Setting Up

1. User Setting: With the device off, press the SET button (5). User 1 or 2 will appear. Use the MEM button (3) to select a user. Press SET (5) to confirm. Proceed to date setting.
2. Date Setting: The year field flashes. Press MEM (3) to set the year. Press SET (5) to confirm. Proceed to month and day setting.
3. Month and Day Setting: The month field flashes. Press MEM (3) to set the month. Press SET (5) to confirm. The day field flashes. Press MEM (3) to set the day. Press SET (5) to confirm. Proceed to time setting.
4. Time Setting: The hour field flashes. Press MEM (3) to set the hour. Press SET (5) to confirm. The minute field flashes. Press MEM (3) to set the minute. Press SET (5) to confirm. Setting is complete. "CL" appears. Exit setting mode by pressing SET (5). Settings are lost upon battery replacement and must be redone.

Applying the Cuff

Diagram Description (Figure 1, 2, 3):

Figure 1 shows the cuff being prepared. Figure 2 illustrates the correct placement on the arm: air hose in the center, 2-3 cm above the elbow (a: center of arm, b: 2-3 cm above elbow). Figure 3 shows correct seated posture for measurement.

1. Insert the air hose connector into the left-side opening (7) of the device.
2. Fold the cuff open and thread it through the metal buckle so the fastening is on the outside of the arm, forming a cylinder (Fig. 1).
3. Place the cuff on the left upper arm. The air hose should be centered on the arm, aligned with the middle finger (Fig. 2a). The lower edge of the cuff should be about 2-3 cm above the elbow (Fig. 2b). Tighten the cuff and fasten the Velcro (Fig. 2c).
4. Measure on a bare arm.
5. Use the right arm only if the left cannot be used. Always measure on the same arm.
6. Correct measurement posture while seated (Fig. 3).

Measuring Blood Pressure

After correctly applying the cuff, begin the measurement:

1. Turn on the device by pressing the START/STOP button (4).
2. Two short beeps sound, and all display indicators appear. This is a display check.
3. The device is ready for measurement; '0' flashes for about 2 seconds. The cuff inflates automatically to measure blood pressure. The display shows increasing pressure.
4. The device inflates the cuff to the required pressure, then slowly deflates it for measurement. When a signal is detected, the pulse symbol (w) flashes. A beep sounds with each detected heartbeat.
5. Upon completion, a long beep sounds, and the cuff deflates. Systolic, diastolic pressure, and heart rate appear on display (8). The blood pressure indicator pulses next to the corresponding color bar based on classification. If an irregular heart rhythm is detected, the irregular heart rhythm indicator (t) also flashes.
6. Measured values are automatically saved in the selected memory (o). Each memory can store up to 90 measurements with date and time.
7. Results remain on screen. If no button is pressed, the device automatically switches off after approx. 3 minutes. It can also be switched off using the START/STOP button (4).

Interrupting a Measurement

If a measurement needs to be interrupted (e.g., due to patient discomfort), press the START/STOP button (4) at any time. The cuff will immediately deflate automatically.

Stored Values

Displaying Stored Values

The device has two separate memories, each storing up to 90 measurements. Values are saved automatically in the selected memory. To view stored values, press the MEM button (3) when the device is off. Average values are displayed first. Subsequent presses of MEM (3) show the last recorded measurement, then earlier ones. If no button is pressed, the device turns off after approx. 120 seconds. Pressing START/STOP (4) exits memory mode and turns off the device. If a memory is full (90 values), new measurements overwrite the oldest.

Deleting Stored Values

To permanently delete all stored values: With the device off, press the SET button (5) seven times until "CL" appears. Press START/STOP (4); "CL" flashes three times during deletion. After pressing MEM (3), "M" and "no" appear, indicating the memory is empty.

Troubleshooting

Error Display

General Problems

If user troubleshooting is not possible, contact the manufacturer. Do not disassemble the device yourself.

Cleaning and Care

Remove batteries before cleaning. Clean the device with a soft cloth slightly dampened with mild soap solution. Do not use harsh cleaners, alcohol, naphtha, thinner, or gasoline. Do not immerse the device or accessories in water. Ensure no water enters the device.

Do not wet or wash the cuff with water. If the cuff gets wet, gently wipe it with a dry cloth. Lay the cuff flat, do not roll it, and let it air dry completely. Protect the device from direct sunlight, dirt, and moisture. Avoid excessive heat or cold. Store the device in its bag when not in use. Keep it in a clean, dry place.

Disposal Instructions

This device must not be disposed of with household waste. Users must return all electrical and electronic devices, whether containing hazardous substances or not, to designated collection points or retail outlets for environmentally friendly disposal. Remove batteries before disposal. Dispose of used batteries as special waste or at a battery collection point, not in household waste. Contact local authorities or the retailer for disposal inquiries.

Directives and Standards

This device complies with EU standards for non-invasive blood pressure monitors. It is CE certified (CE 0297) and conforms to European standards EN 1060-3, EN 81060-1, and EN 81060-2. It meets the requirements of the EU Council Directive "93/42/EEC of 14 June 1993 concerning medical devices".

Electromagnetic Compatibility: (See separate leaflet)

Technical Specifications

Warranty and Repair Conditions

For warranty claims, contact the specialist retailer or the service center directly. If the device needs to be sent, state the type of defect and include a copy of the proof of purchase.

The following warranty conditions apply:

1. medisana products are covered by a three-year warranty from the date of sale. The date of sale must be documented by a receipt or VAT invoice for warranty claims.
2. Defects due to material or manufacturing errors will be repaired free of charge under warranty.
3. Warranty service does not extend the warranty period, nor does it apply to replaced components.
4. The warranty does not cover:
   • Damage caused by improper use, e.g., failure to follow the user manual.
   • Damage caused by repairs by the buyer or unauthorized third parties.
   • Transport damage incurred during transit from the manufacturer to the consumer or during shipment to a service point.
   • Accessories subject to normal wear and tear.
5. Liability for indirect and direct damages caused by the device is excluded, even if the device damage is recognized as a warranty case.

medisana GmbH, Carl-Schurz-Str. 2, 41460 NEUSS, GERMANY.

The address of the service point is in a separate attachment.