BC 21 - Blood pressure monitor BEURER - Free user manual and instructions

USER MANUAL BC 21 BEURER

Blood pressure monitor with cuff

Instructions for use Dear customer, Thank you for choosing a product from our range. Our name stands for high-quality, thoroughly tested prod- ucts 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 BC21 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- ENGLISH

1. Getting to know your device .....................................19

7. Displaying and deleting measured values ...............29

8. Error messages/troubleshooting ............................. 31

9. Cleaning and storing the device and cuff ................31

Contents 19sure, save the measurements and display the devel- opment 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 dierent languages (German, English, French, Italian and Turkish). The instructions and measurement results are announced to you in the selected language.

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: 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 Separate the packaging elements and dispose of them in accordance with local regulations.

Marking to identify the packaging material. A = Material code, B = Material number: 1-7 = Plastics, 20-22 = Paper and cardboard Separate the product and packaging elements and dispose of them in ac- cordance with local regulations. Manufacturer Storage/Transport Permissible storage and transport temperature and humidity 20Operating Permissible operating temperature and humidity IP 22 Device protected against foreign objects ≥ 12.5 mm and against water dripping at an angle

Serial number Item number Medical device This product satisfies the require- ments of the applicable European and national directives. 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 measure

ments in succession, make sure always to wait for at least 1 minute between the individual measure- ments

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

The measurements taken by you are for your infor- mation 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 new- borns 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 dis- orders 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 (includ- ing vascular constriction), the accuracy of the wrist measurement is limited. In this case you should use an upper arm blood pressure monitor instead. 21• This device is not intended for use by people (in- cluding 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 speci- fied 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 unnecessar- ily long time. If the device malfunctions remove the cuff from the arm.

Do not allow sustained pressure in the cuff or fre- quent 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 intravascu- lar 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 cu on your wrist only. Do not place the cu on other parts of the body.

The blood pressure monitor can only be operated with batteries.

The device is only intended for the purpose described in these instructions for use. The man- ufacturer is not liable for damage resulting from improper or careless use. Instructions for storage and maintenance

The blood pressure monitor is made from preci- sion 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 sun- light. – Do not drop the device. 22– 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.

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 Ser- vices 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 use- ful life. Dispose of the device at a suitable local collection or recycling point in your country. Dispose of the device in accord- ance with EC Directive – WEEE (Waste Elec- trical and Electronic Equipment). If you have any questions, please contact the local authorities re- sponsible for waste disposal.

5. Battery compartment

3. Diastolic pressure

6. Inflate, release air ( )

age value ( ), morning ( ), evening ( )

10. Voice output / sound

11. Battery replacement symbol

4. Preparing for the measurement

Inserting the battery

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.

• Empty, completely flat batteries must be disposed of through specially designated collection boxes, recy- cling points or electronics retailers. You are legally re- quired 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. Hour format

Language It is essential to set the date and time. Otherwise, you will not be able to save your measured values cor- rectly 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 de- vice is set to German 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

Press and hold the memory button M for 5 seconds or insert the batteries. The full display is shown briefly. The hour format then flashes on the display.

Now select the desired hour format using the memory button M and confirm with the START/ STOP button . Date The year flashes on the display.

Select the desired year using the memory button M and confirm with the START/STOP button . The month flashes on the display.

Select the desired month with the memory button M and confirm with the START/ STOP button . 25The day flashes on the display.

Select the desired day with the memory but- ton M and confirm with the START/STOP button . If the hour format is set as 12h, the day/month display sequence is reversed. Time The hours flash on the display.

Select the desired hour using the memory button M and confirm with the START/STOP button . The minutes flash on the display.

Select the desired minute using the memory button M and confirm with the START/STOP button . Language

appears in the display for Ger- man. To select another language, press and hold the memory button M for 3 seconds each time until the desired language is shown. Confirm using the memory button M. = German = English = French = Italian = Turkish = No voice output, only acoustic signal Voice output volume

(loud) appears in the display. To change the voice output volume, press and hold the memory button M for 3seconds each time. Confirm using the memory button M. = quiet, = medium, = loud = voice output is o. Once all the data has been set, the device switches o 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 pres

sure values are different. Always perform the meas- urement 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

26for the measurement. We generally recommend you carry out the measurement on the left wrist.

Expose your left wrist. Ensure that the circulation of the arm is not hindered by tight clothing or simi- lar. 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 posi- tioned 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. Oth- erwise deviations can occur.

You can take the measurement while sitting or lying down. To take your blood pressure, make sure you are sitting com- fortably with your arms and back leaning on some- thing. 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 devia- tions 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.

easuring blood pressure As described above, attach the cu and adopt the posture in which you want to perform the measure- ment.

• The last measured value is dis- played and the blood pressure monitor automatically begins the measurement after 3 seconds. You can cancel the measurement at any time by pressing the START/STOP button . 27As soon as a pulse is found, the pulse symbol will be displayed.

Systolic pressure, diastolic pres- sure and pulse readings are dis- played.

appears if the measurement has not been performed properly. 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 memory button M. If you do not select a user memory, the measurement is stored in the most recently used user memory. The relevant

symbol appears on the display.

Press the START/STOP button to switch o the blood pressure monitor. The measurement is then stored in the selected user memory. If you forget to turn o the device, it will switch o 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 sym

This can be an indicator for arrhythmia. Arrhyth- mia is an illness in which the heart rhythm is abnor- mal 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 meas- urement. 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 treat- ment based on the measurements can be danger- ous. Always follow your doctor’s instructions. 28Risk indicator: The measurements can be classified and evaluated in accordance with the following table. However, these standard values serve only as a gen- eral guideline, as the individual blood pressure varies in dierent people and dierent age groups etc. It is important to consult your doctor regularly for ad- vice. 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 pres- sure values fall into. If the values of systole and di- astole fall into two dierent 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’. Blood pressure value category Systole (in mmHg) Diastole (in mmHg) Action Level 3: severe hypertension ≥ 180 ≥ 110 seek medical attention Level 2: moderate hypertension 160 – 179 100 – 109 seek medical attention Blood pressure value category Systole (in mmHg) Diastole (in mmHg) Action Level 1: mild hypertension 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)

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. 29User memory flashes on the display. The average value of all saved measured values in this user me- mory is displayed. To change the user memory, press and hold the memory button M for approx. 3 seconds. Average values

Press the memory button M. flashes on the display. The average value of the morning measurements for the last 7 days is displayed (morning: 5.00 a.m. –

Press the memory button M. flashes on the display. The average value of the evening measurements for the last 7 days is displayed (evening: 6.00 p.m. –

Individual measured values

When you press the memory button M again, the last in- dividual measurement is dis- played (in this example, meas- urement 03 of user 1).

When the memory button M is pressed again, you can view your individual measurements.

To switch the device o 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 memo- ry, you must first select a user memory.

Start the retrieval of the average measured va- lues. flashes on the display and the average value of all saved measured values in this user memory is displayed.

Press and hold the memory button M and the START/STOP button simultaneously for 5seconds. All values of the current user me

mory are deleted and the device switches o.

308. Error messages/troubleshooting

In the event of errors, the error message _ appears on the display. Error messages may appear if

• the systolic or diastolic pressure could not be measured

appears on the display),

the systolic or diastolic pressure was outside the measurement range (“ ” or “ ” appears on the display),

• the cuff is fastened too tightly or loosely (

appears on the display),

• the blood pressure is higher than 300 mmHg ( ap- pears on the display),

• inflating takes longer than 180 seconds ( appears on the display),

• there is a system or device error ( , , or appears on the display),

• 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. Technical alarm – description Should the recorded blood pressure (systolic or dias

tolic) lie outside the limits specified in the section “Technical specifications”, the technical alarm will appear on the display indicating either “ ” or “ ”. 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 dis

play will disappear automatically after about 8 sec- onds.

9. Cleaning and storing the device and

Clean the device and cu carefully using a slightly damp cloth only.

Do not use any cleaning agents or solvents.

Under no circumstances hold the device and cu under water, as this can cause liquid to enter and damage the device and cu.

If you store the device and cu, do not place heavy objects on the device and cu. Remove the batter- ies. 3110. Technical specifications Model no. BC 21 Measurement method Oscillometric, non-invasive blood pressure measurement on the wrist Measurement range Cuff pressure 0 – 300 mmHg, Systolic 60 -260 mmHg, Diastolic 40 -199 mmHg, Pulse 40 –180 beats/minute Display accuracy Systolic ± 3 mmHg, Diastolic ± 3 mmHg, Pulse ± 5% of the value shown Measurement inaccuracy Max. permissible standard deviation according to clinical testing: Systolic 8 mmHg / Diastolic 8 mmHg Memory 2 x 60 memory spaces Dimensions L 87 mm x W 67 mm x H31 mm Weight Approximately 105 g (without batteries) Cuff size 140 to 195 mm Permissible operating conditions + 10°C to +40°C, ≤ 85% relative humidity (non-condensing) Permissible storage conditions -20°C to +50°C, ≤ 85% relative humidity, 800 –1050 hPa ambient pressure Power supply 2 x 1.5V AAA batteries Battery life For approx. 200 measurements, depending on levels of blood pressure and inflation pressure Accessories Instructions for use, 2 x 1.5V AAA batteries, storage box Classification Internal supply, IP22, no AP or APG, continuous operation, application part type BF 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, IEC61000-4-2, IEC 61000-4-3, IEC 61000-4-8) and is subject to particular precautions with regard to electromagnetic compatibility. Please note that 32portable 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 (Non- invasive sphygmomanometers – Part 3: Supple- mentary requirements for electro-mechanical blood pressure measuring systems) and IEC80601-2-30 (Medical electrical equipment – Part 2 – 30: Par- ticular requirements for the basic safety and essen- tial performance of automated non-invasive sphyg- momanometers).

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 com- mercial medical purposes, it must be regularly tested for accuracy by appropriate means. Pre- cise instructions for checking accuracy may be requested from the service address. Notes on electromagnetic compatibility

The device is suitable for use in all environments lis- ted in these instructions for use, including domestic environments.

The use of the device may be limited in the pre- sence of electromagnetic disturbances. This could result in issues such as error messages or the fai- lure 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 immu- nity; 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 guar- antee conditions can be found in the guarantee leaflet supplied. Subject to errors and changes 33Contenu