BC 80 - Blood pressure monitor BEURER - Free user manual and instructions

USER MANUAL BC 80 BEURER

1. Getting to know your device

Check that the packaging of the Beurer BC80 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 pressure, 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. Store these instructions for use for future reference and make them accessible to other users.

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: ENGLISH

1. Getting to know your device ............................................15

6. Displaying and deleting measurements ...........................23

Contents16 Attention Note Note on important information Observe the instructions for use Application part, type BF Direct current Disposal in accordance with the Waste Electrical and Electronic Equipment EC Directive – WEEE Manufacturer Storage RH 10-93

Serial number The CE labelling certifies that the product complies with the essential requirements of Directive 93/42/EEC on medical products. Notes on use

In order to ensure comparable values, always measure your blood pressure at the same time of day.

Before every measurement, relax for about five minutes.

If you want to perform several measurements on the same person, wait five minutes between each measurement.

Do not take a measurement within 30 minutes of eating, drinking, smoking or exercising.

Repeat the measurement if you are unsure of the measured value.

The measurements taken by you are for your information only – they are no substitute for a medical examination. Discuss the measurements with your doctor and never base any medical decisions on them (e.g. medicines and their ad- ministration).

Do not use the blood pressure monitor on newborns or patients with pre-eclampsia. We recommend consulting a doctor before using the blood pressure monitor during preg- nancy.

In the case of restricted circulation on the arm as a result of chronic or acute vascular diseases (including vascular con- striction), the accuracy of the wrist measurement is limited. In this case you should avoid using an upper arm blood pres- sure monitor.17

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, circu- latory disorders and arrhythmias as well as chills or shaking.

The blood pressure monitor must not be used in connection with a high-frequency surgical unit.

Only use the unit 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 circula- tion 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 meas- urements. The resulting restriction of the blood flow may cause injury.

Ensure that the cuff is not placed on an arm in which the arteries or veins are undergoing medical treatment, e.g. in- travascular access or therapy, or an arteriovenous (AV) shunt.

Do not use the cuff on people who have undergone a mas- tectomy.

Do not place the cuff over wounds as this may cause further injury.

The blood pressure monitor can only be operated with bat- teries.

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 elec- tronic components. The accuracy of the measurements 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 electromag- netic fields and keep it away from radio systems or mobile telephones.

Do not press the buttons before the cuff is placed on the arm.

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, flush out the affected areas with water and seek medical assis- tance.

Choking hazard! Small children may swallow and choke on batteries. Store the batteries out of the reach of small children.

If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.

Protect the batteries from excessive heat.

Risk of explosion! Never throw batteries into a fire.

If the device is not to be used for a long period, take the batteries out of the battery compartment.

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 will result in voiding of 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. 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.

1. Scale for classifying the measurements

8. Battery compartment lid

1. Classification of measurements

4. Diastolic pressure

5. Resting indicator (symbol is inactive)

9. Pump up, release air (arrow)

), morning ( AM  ), evening ( PM 

4. Preparing for the measurement

Remove the battery com

partment lid on the left side of the device.

Insert two 1.5 V micro (al- kaline type LR03) batter- ies. Make sure that the batteries are inserted the correct way round. Do not use rechargeable batteries.

Close the battery compartment lid again carefully. If the battery change symbol is flashing and

appears, no more measurements are possible and you must replace all batteries. All display elements are briefly displayed, 24h flashes in the display. Now set the date and time as described below. Battery disposal

• The 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 mercury20 Setting the hour format, date and time This menu allows you to set the following functions, one after another. Hour format

Time 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. If you press and hold the M1 or M2 memory button, you can set the values more quickly. Hour format

Press and hold the START/STOP button for 5 seconds.

Select the desired hour format using the M1/ M2 memory buttons and confirm with the START/STOP button . Date The year flashes on the display.

Select the year using the M1/M2 memory buttons and confirm with the START/STOP button . The month flashes on the display.

Select the month using the M1/M2 memory but- tons and confirm with the START/STOP button

Select the day using the M1/M2 memory buttons and confirm with the START/STOP button . If the hour format is set as 12h, the day/month dis- play sequence is reversed. Time The hours flash on the display.

Select the hour using the M1/M2 memory buttons and confirm with the START/STOP button . The minutes flash on the display.

Select the minute with the M1/M2 memory but- tons and confirm with the START/STOP button

Once all the data has been set, the device switches off au- tomatically.

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.21

Close the cuff with the hook-and-loop fastener such that the upper edge of the device is positioned approx. 1 cm under- neath the heel of the hand.

The cuff must be fitted tightly around the wrist, but must not constrict. Adopt the correct posture

Before every measurement, relax for about five minutes. Oth- erwise deviations can occur.

You can take the measurement while sitting or lying. 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 rest your arm and move it. Always make sure that the cuff is at heart level. Otherwise significant deviations can occur. Relax your arm and the palm of your hand. An O.K. symbol bar is integrated into the device to additionally assist you. It signals the correct position of the blood pressure monitor. You are in the right position if you can see O.K. on the display.

To avoid falsifying the measurement, it is important to remain still during the measurement and not to speak. Performing the blood pressure measurement As described above, attach the cuff and adopt the posture in which you want to perform the measurement.

Press the START/STOP button to start the blood pressure monitor. All displays will illuminate briefly. The blood pressure monitor will begin the measurement automatically after 3 seconds. The measurement is taken during the infla- tion phase. You can cancel the measurement at any time by pressing the START/STOP button . As soon as a pulse is found, the pulse symbol is displayed.

The systolic pressure, diastolic pressure and pulse rate measurements are displayed.

_ appears if the measurement could not be performed prop- erly. Observe the chapter on error messages/ troubleshooting in these instructions for use and repeat the measurement.

Now select the desired user memory by pressing the M1 or M2 memory buttons. If you do not select a user memory, the measurement is stored in the most recently used user memory. The relevant symbol M1 or M2 appears in the display.

Press the START/STOP button to switch off the blood pressure monitor. The measurement is then stored in the selected user memory.

!22 If you forget to turn off the device, it will switch off auto- matically after approx. 3 minutes. In this case too, the value is stored in the selected or most recently used user memory.

Wait at least 5 minutes before taking another measurement. 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 measure- ment 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 fre- quently, please consult your doctor. Self-diagnosis and treat- ment based on the measurements can be dangerous. Always follow your GP’s instructions. Classification of measurements: The measurements can be classified and evaluated in ac- cordance 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 unit 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 classifica- tion on the device always shows the higher category; for the example given this would be ‚High normal‘. Blood pressure value category Systole (in mmHg) Diastole (in mmHg) Action Setting 3: severe hyper- tension ≥ 180 ≥ 110 seek medical at- tention Setting 2: moderate hyper- tension 160 – 179 100 – 109 seek medical at- tention Setting 1: mild hyperten- sion 140 – 159 90 – 99 regular monitoring by doctor High normal 130 – 139 85 – 89 regular monitoring by doctor Normal 120 – 129 80 – 84 self-monitoring Optimal < 120 < 80 self-monitoring Source: WHO, 1999 (World Health Organization)23

6. Displaying and deleting measurements

User memory The results of every successful measurement are stored together with the date and time. If there are more than 60 measurements, the oldest measurements are lost.

To access memory recall mode, press the M1 or M2 memory button to select your desired user memory ( ). – To view the measurements for user memory press the M1 memory button. – To view the measurements for user memory , press the M2 memory button. Your last measurement will appear on the display. Average values

Press the relevant memory button (M1 or M2). Press the M1 button if you have selected user memory

1. Press the M2 memory button if you have selected user

flashes on the display. The average value of all saved meas- ured values in this user memory is displayed.

flashes on the display. The average value of the morning meas- urements for the last 7 days is displayed (morning: 5.00 a.m. – 9.00 a.m.).

flashes on the display. The average value of the evening meas- urements for the last 7 days is displayed (evening: 6.00 p.m. – 8.00 p.m.). Individual measured values

When the relevant memory button (M1 or M2) is pressed again, the last individual measurement is displayed (in this example, measurement 03).

When the relevant memory button (M1 or M2) is pressed again, you can view your individual measurements.

To switch the device off again, press the START/STOP button . You can exit the menu at any time by pressing the START/STOP button . Deleting measured values

To clear the memory of the relevant user memory, you must first select a user memory.24

Start individual measurement access.

Press and hold the M1 & M2 memory buttons for 5 sec- onds.

appear on the display. All the values in the current user memory are deleted. The device will then switch off automati- cally.

7. Transferring measurements

Connect the blood pressure monitor to your PC using the USB cable. No data transfer may be launched whilst performing a measurement.

is shown on the display. Begin the data transfer in the “HealthManager” PC software. During the data transfer, an animation is shown on the display. A successful data transfer is displayed as in figure 1. If the data transfer is unsuccessful, an error message appears as in figure 2. In this case, interrupt the PC connection and start the data transfer again. After 30 seconds of not being in use or if communication with the PC is interrupted, the blood pressure monitor switches itself off automatically.

appears on the display. Error messages may appear if:

It was not possible to record the pulse: E 1

You move or speak during the measurement::

The cuff is fastened too tightly or loosely:

Errors occur during the measurement:

The pump pressure is higher than 300 mmHg:

The batteries are almost empty

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

9. Cleaning and maintenance

Clean your blood pressure monitor carefully using a slightly damp cloth only.

Do not use any cleaning agents or solvents.

Under no circumstances should you hold the unit under water, as this can cause liquid to enter and damage the unit.

Never place any heavy objects on the device.

Model no. BC 80 Measurement method Oscillometric, non-invasive blood pres

curacy Max. permissible standard deviation according to clinical testing: Systolic 8 mmHg / Diastolic 8 mmHg Memory 2 x 60 memory spaces Dimensions L 97 mm x W 68 mm x H 22 mm Weight Approximately 108 g (without batteries) Cuff size 135 to 230 mm Permissible operating conditions +5 °C to +40 °C, 15-93 % relative hu

pending on levels of blood pressure and pump pressure Accessories Instructions for use, 2 x 1.5V AAA bat- teries, storage box Classification Internal supply, IPX0, no AP or APG, continuous operation, application part type BF

This device is in line with European Standard EN 60601-1-2 and is subject to particular precautions with regard to electro

magnetic compatibility (EMC). Please note that portable and mobile HF communication systems may interfere with this unit. More details can be requested from the stated Customer Services address or found at the end of the instructions for use.

This device corresponds to the EU Medical Devices Direc- tive 93/42/EEC, the German Medical Devices Act (Mediz- inproduktgesetz) and the standards EN1060-1 (non-inva- sive sphygmomanometers, Part 1: General requirements), EN 1060-3 (non-invasive sphygmomanometers, Part3: 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).

± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%. Power frequency (50Hz) magnetic field

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical loca

tion in a typical commercial or hospital environment.99 Guidance and manufacture’s declaration – electromagnetic immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacture’s declaration – electromagnetic immunity The BC80 blood pressure monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the BC80 blood pressure monitor should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Conducted RF

3 V rms 150 kHz to 80 MHz 3 V/m 80 MHz to

3 V rms 3 V/m Portable and mobile RF communications equipment should be used no closer to any part of the BC80 blood pressure monitor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = d = 80 MHz to 800 MHz d = 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,

should be less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the BC80 blood pressure monitor is used exceeds the applicable RF compliance level above, the BC80 blood pressure monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the BC80 blood pres- sure monitor.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM – for100 EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the BC80 blood pressure monitor The BC80 blood pressure monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the BC80 blood pressure monitor can help prevent electromagnetic interference by maintaining a minimum distance bet

ween portable and mobile RF communications equipment (transmitters) and the BC80 blood pressure monitor as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz d = 80 MHz to 800 MHz d = 800 MHz to 2.5 GHz d =

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reflection from structures, objects and people. 751.403-0216 BEURER GmbH • Söflinger Str. 218 • 89077 Ulm (Germany) • www.beurer.com www.beurer-gesundheitsratgeber.com • www.beurer-healthguide.com