beurer BC 21 Blood Pressure Monitor Instruction Manual

June 5, 2024
Beurer

beurer BC 21 Blood Pressure Monitor Instruction Manual

beurer BC 21 Blood Pressure Monitor Instruction
Manual.jpg

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Included in delivery

  • Blood pressure monitor with cuff
  • 2 x 1.5 V LR03 AAA batteries
  • Storage box
  • Instructions for use

Dear customer,
Thank you for choosing a product from our range. Our name stands for high- quality, thoroughly tested products for applications in the areas of heat, weight, blood pressure, body temperature, pulse, gentle therapy, massage, beauty and air.

Read these instructions for use carefully and keep them for later use, be sure to make them accessible to other users and observe the information they contain.
With kind regards,
Your Beurer team

1. Getting to know your device

Check that the packaging of the Beurer BC 21 blood pressure monitor has not been tampered with and make sure that all the required contents are present. The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of arterial blood pressure values in human adults. This allows you to quickly and easily measure your blood pres-sure, save the measurements and display the development of the measurements. You are also warned of possible existing cardiac arrhythmia. The recorded values are classified and evaluated graphically. The wrist blood pressure monitor also has voice output in five different languages (German, English, French, Italian and Turkish). The instructions and measurement results are announced to you in the selected language.

2. Important notes

Signs and symbols
The following symbols are used in these instructions for use, on the packaging and on the type plate for the device and the accessories:

FIG 1 Signs and symbols.JPG

FIG 2 Signs and symbols.JPG

FIG 3 Signs and symbols.JPG

Notes on use

  • In order to ensure comparable values, always measure your blood pressure at the same time of day.
  • Do not take a measurement within 30 minutes of eating, drinking, smoking or exercising.
  • Before the initial blood pressure measurement, make sure always to rest for about 5 minutes.
  • Furthermore, if you want to take several measurements in succession, make sure always to wait for at least 1 minute between the individual measurements
  • Repeat the measurement if you are unsure of themeasured value.
  • The measurements taken by you are for your information only – they are no substitute for a medical examination! Discuss the measured values with your doctor and never base any medical decisions on them (e.g. medicines and their dosages).
  • Do not use the blood pressure monitor on newborns or patients with pre-eclampsia. Before using the blood pressure monitor during pregnancy, we recommend you consult with a doctor.
  • Cardiovascular diseases may lead to incorrect measurements or have a detrimental effect on measurement accuracy. The same also applies to very low blood pressure, diabetes, circulatory disorders and arrhythmias as well as chills or shaking.
  • In the case of restricted circulation on the arm as a result of chronic or acute vascular diseases (including vascular constriction), the accuracy of the wrist measurement is limited. In this case you should use an upper arm blood pressure monitor instead.
  • This device is not intended for use by people (including children) with restricted physical, sensory or mental skills or a lack of experience and/or a lack of knowledge, unless they are supervised by a person who is responsible for their safety or are instructed by such a person in how to use the device. Supervise children around the device to ensure they do not play with it.
  • The blood pressure monitor must not be used in connection with a high-frequency surgical unit.
  • Only use the device on people who have the specified wrist measurement for the device.
  • Please note that when inflating, the functions of the limb in question may be impaired.
  • During the blood pressure measurement, the blood circulation must not be stopped for an unnecessarily long time. If the device malfunctions remove the cuff from the arm.
  • Do not allow sustained pressure in the cuff or frequent measurements. The resulting restriction of the blood flow may cause injury.
  • Make sure that the cuff is not placed on an arm in which the arteries or veins are undergoing medical treatment, e.g. intravascular access or intravascular or therapy, or an arteriovenous (AV) shunt.
  • Do not use the cuff on people who have undergone a mastectomy.
  • Do not place the cuff over wounds as this may cause further injury.
  • Place the cuff on your wrist only. Do not place the cuff on other parts of the body.
  • The blood pressure monitor can only be operated with batteries.
  • To conserve the batteries, the blood pressure monitor switches off automatically if you do not press any buttons for one minute.
  • The device is only intended for the purpose described in these instructions for use. The manufacturer is not liable for damage resulting from improper or careless use.

Instructions for storage and maintenance

  • The blood pressure monitor is made from precision and electronic components. The accuracy of the measured values and service life of the device depend on its careful handling:
    – Protect the device from impacts, humidity, dirt, marked temperature fluctuations and direct sunlight.
    – Do not drop the device. – Do not use the device in the vicinity of strong electromagnetic fields and keep it away from radio systems or mobile telephones.

  • We recommend that the batteries be removed if the device will not be used for a prolonged period of time.

Notes on handling batteries

  • If your skin or eyes come into contact with battery fluid, rinse the affected areas with water and seek medical assistance.
  • Choking hazard! Small children may swallow and choke on batteries. Store batteries out of the reach of small children.
  • Observe the plus (+) and minus (-) polarity signs.
  • If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.
  • Protect batteries from excessive heat.
  • **Risk of explosion!** Do not throw batteries into a fire.
  • Do not charge or short-circuit batteries.
  • Use identical or equivalent battery types only.
  • Always replace all batteries at the same time.
  • Do not use rechargeable batteries.
  • Do not disassemble, split or crush the batteries.

Instructions for repairs and disposal

  • Batteries do not belong in household waste. Please dispose of empty batteries at the collection points intended for this purpose.
  • Do not open the device. Failure to comply with this instruction will void the warranty.
  • Do not repair or adjust the device yourself. Proper operation can no longer be guaranteed in this case.
  • Repairs must only be carried out by Customer Services or authorised suppliers. Before making a claim, please check the batteries first and replace them if necessary.
  • For environmental reasons, do not dispose of the device in the household waste at the end of its useful life. Dispose of the device at a suitable local collection or recycling point in your country. Dispose of the device in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equipment). If you have any questions, please contact the local authorities responsible for waste disposal.

3. Device description

  1. Memory button M
  2. Start/stop button
  3. Wrist cuff
  4. Display
  5. Battery compartment lid
  6. Risk indicator

Information on the display:

FIG 5 Information on the display.JPG

4. Preparing for the measurement

Inserting the battery

FIG 6 Inserting the battery.JPG

  • Remove the battery compartment lid on the left side of the device. To simply remove the lid, lightly press on it to undo the lock. Then remove the lid.
  • Insert two 1.5 V micro (alkaline type LR03) batteries. Make sure that the batteries are inserted the correct way round in accordance with the markings. Do not use rechargeable batteries.
  • Close the battery compartment lid again carefully.

If the battery replacement symbol is displayed, you can no longer perform any measurements and must replace all batteries. Once the batteries have been removed from the device, the date and time must be set again. Any saved measured values are retained.

Battery disposal

  • Empty, completely flat batteries must be disposed of through specially designated collection boxes, recycling points or electronics retailers. You are legally required to dispose of the batteries.
  • The codes below are printed on batteries containing harmful substances: Pb = Battery contains lead,
    Cd = Battery contains cadmium,
    Hg = Battery contains mercury.

Setting the hour format, date, time and language

There are two different ways to access the menu from which you can adjust the settings:

  • Before initial use and after each time you replace the battery: When inserting the batteries into the device you will be taken to the relevant menu automatically.
  • If the batteries have already been inserted: With the device switched off press and hold the START/STOP button for approx. 5 seconds.

FIG 8 Setting the hour format, date, time and
language.JPG

It is essential to set the date and time. Otherwise, you will not be able to save your measured values correctly with a date and time and access them again later. The device also has voice output in 5 languages (German, English, French, Italian and Turkish). The device is set to English when supplied to the customer.

In order to select your values faster when using the memory button M , you can also press and hold the memory button M.

Hour format

FIG 9 Hour format.JPG

Date

FIG 10 Date.JPG

Language

FIG 12 Language.JPG

FIG 13 Voice output volume.JPG

Once all the data has been set, the device switches off automatically.

5. Measuring blood pressure

Attaching the cuff
Blood pressure may vary between the right and left arm, which may mean that the measured blood pressure values are different. Always perform the measurement on the same arm. If the values between the two arms are significantly different, please consult your doctor to determine which arm should be used for the measurement. We generally recommend you carry out the measurement on the left wrist.

FIG 14 Attaching the cuff.JPG

  • Expose your left wrist. Ensure that the circulation of the arm is not hindered by tight clothing or similar. Place the cuff on the inside of your wrist.
  • Close the cuff with the hook-and-loop fastener such that the upper edge of the device is positioned approx. 1 cm underneath the heel of the hand.
  • The cuff must be fitted tightly around the wrist, but must not constrict.

Adopting the correct posture

  • Before every measurement, relax for about 5 minutes. Otherwise deviations can occur.

  • You can take the measurement while sitting or lying down. To take your blood pressure, make sure you are sitting comfortably with your arms and back leaning on something.
    Do not cross your legs. Place your feet flat on the ground. Make sure to support your arm and bend it. Always make sure that the device is at heart level during the measurement. Otherwise significant deviations can occur. Relax your arm and the palm of your hand.

  • To avoid falsifying the measurement, it is important to remain still during the measurement and not to speak.

Measuring blood pressure
As described above, attach the cuff and adopt the posture in which you want to perform the measurement.

FIG 16 Measuring blood pressure.JPG

FIG 17 Measuring blood pressure.JPG

If you forget to turn off the device, it will switch off automatically after approx. 1 minute.
In this case too, the value is stored in the selected or most recently used user memory.

Wait at least 1 minutes before taking another measurement!

6. Evaluating results

Cardiac arrhythmia:
This device can identify potential disruptions of the heart rhythm when measuring and, if necessary, indicates this after the measurement with the symbol

This can be an indicator for arrhythmia. Arrhythmia is an illness in which the heart rhythm is abnormal because of flaws in the bioelectrical system that regulates the heartbeat. The symptoms (skipped or premature heart beats, pulse being slow or too fast) can be caused by factors such as heart disease, age, physical make-up, excess stimulants, stress or lack of sleep. Arrhythmia can only be determined through an examination by your doctor.

If the symbol is shown on the display after the measurement has been taken, repeat the measurement. Please ensure that you rest for 5 minutes beforehand and do not speak or move during the measurement. If the symbol appears frequently, please consult your doctor. Self-diagnosis and treatment based on the measurements can be dangerous. Always follow your doctor’s instructions.

Risk indicator:
The measurements can be classified and evaluated in accordance with the following table.

However, these standard values serve only as a general guideline, as the individual blood pressure varies in different people and different age groups etc. It is important to consult your doctor regularly for advice. Your doctor will tell you your individual values for normal blood pressure as well as the value above which your blood pressure is classified as dangerous. The classification on the display and the scale on the device show which category the recorded blood pressure values fall into. If the values of systole and diastole fall into two different categories (e.g. systole in the ‘High normal’ category and diastole in the ‘Normal’ category), the graphical classification on the device always shows the higher category; for the example given this would be ‘High normal’.

FIG 18 Risk indicator.JPG

FIG 19 Risk indicator.JPG

Source: WHO, 1999 (World Health Organization)

7. Displaying and deleting measured values

User memory
The results of every successful measurement are stored together with the date and time. The oldest measurement is overwritten in the event of more than 60 measurements.

  • To retrieve the measurement, press the memory button M.

FIG 20 Displaying and deleting measured values.JPG

FIG 21 Displaying and deleting measured values.JPG

FIG 22 Displaying and deleting measured values.JPG

8. Error messages/troubleshooting

FIG 23 Error messages.JPG

In such cases, repeat the measurement. Ensure that you do not move or speak. If necessary, reinsert or replace the batteries.

Technical alarm – description
Should the recorded blood pressure (systolic or diastolic) lie outside the limits specified in the section “Technical specifications”, the technical alarm will appear on the display indicating either “ ” or “Lo”. In such cases, you should seek medical assistance and check the accuracy of your procedure.

The limit values for the technical alarm are factory set and cannot be adjusted or deactivated. These alarm limit values are accorded second priority under the standard IEC 60601-1-8.

The technical alarm is a non-locking alarm and does not need to be reset. The signal shown on the display will disappear automatically after about 8 seconds.

9. Cleaning and storing the device and cuff

  • Clean the device and cuff carefully using a slightly damp cloth only.
  • Do not use any cleaning agents or solvents.
  • Under no circumstances hold the device and cuff under water, as this can cause liquid to enter and damage the device and cuff.
  • If you store the device and cuff, do not place heavy objects on the device and cuff. Remove the batteries.

10. Technical specifications

FIG 24 Technical specifications.JPG

FIG 25 Technical specifications.JPG

The serial number is located on the device or in the battery compartment.
Technical information is subject to change without notification to allow for updates.

  • This device complies with European Standard EN60601-1-2 (in accordance with CISPR 11, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-8) and is subject to particular precautions with regard to electromagnetic compatibility. Please note that portable and mobile HF communication systems may interfere with this device.

  • The device complies with the EU Medical Devices
    Directive 93/42/EEC, the German Medical Devices Act (Medizinproduktgesetz) and the standards EN1060-1 (Non-invasive sphygmomanometers
    – Part 1: General requirements), EN1060-3 (Noninvasive sphygmomanometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems) and IEC80601-2-30 (Medical electrical equipment – Part 2 – 30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers).

  • The accuracy of this blood pressure monitor has been carefully checked and developed with regard to a long useful life. If the device is used for commercial medical purposes, it must be regularly tested for accuracy by appropriate means. Precise instructions for checking accuracy may be requested from the service address.

Notes on electromagnetic compatibility

  • The device is suitable for use in all environments listed in these instructions for use, including domestic environments.
  • The use of the device may be limited in the presence of electromagnetic disturbances. This could result in issues such as error messages or the failure of the display/device.
  • Avoid using this device directly next to other devices or stacked on top of other devices, as this could lead to faulty operation. If, however, it is necessary to use the device in the manner stated, this device as well as the other devices must be monitored to ensure they are working properly.
  • The use of accessories other than those specified or provided by the manufacturer of this device can lead to an increase in electromagnetic emissions or a decrease in the device’s electromagnetic immunity; this can result in faulty operation.
  • Failure to comply with the above can impair the performance of the device.

11. Warranty / service

Further information on the guarantee and guarantee conditions can be found in the guarantee leaflet supplied.

Subject to errors and changes

BEURER GmbH • Söflinger Str. 218 • 89077 Ulm (Germany) • www.beurer.com
www.beurer-gesundheitsratgeber.comwww.beurer-healthguide.com

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