BC 50 - Blood pressure monitor BEURER - Free user manual and instructions

Frequently Asked Questions - BC 50 BEURER

USER MANUAL BC 50 BEURER

beurer \_\_\_\_medical

20:32 29:00 128 69 128 87 M1 M2 ① beuer SYS mml/kg DIA mml/kg

BC 50

D Blutdruckmessgerät Gebrauchsanweisung 2–13
GB Blood pressure monitor Instructions for use 14–24
F Tensiomètre Mode d'emploi 25-36
E Tensiómetro Instrucciones de uso....37-48
① Misuratore di pressione Istruzioni per l'uso ....49–59
TR Tansiyon ölçme cihazı Kullanım kılavuzu....60–70
RUS Прибор для измерения артериального давления на запястье Инструкция по применению....71–83
PL Ciśnieniomierz Instrukcja obsługi 84–94
Electromagnetic Compatibility Information .....95-97

CE 0483

DEUTSCH

Inhalt

1 2 3 4 5 6 7 M1 M2 FUS device DIA device

Three identical line drawings of a cylindrical mechanical component with internal features, shown from different angles (no text or symbols)

Silhouette of a person sitting with hands placed on a table, no text or symbols present

Quelle: WHO, 1999 (World Health Organization)

1. Getting to know your device....14
2. Important notes....14
3. Unit description .....17
4. Preparing for the measurement....18
5. Measuring blood pressure....19

Dear customer,

Thank you for choosing one of our products. Our name stands for high-quality, thoroughly tested products for applications in the areas of heat, gentle therapy, blood pressure/diagnosis, weight, massage, beauty and air.

Please read these instructions for use carefully and keep them for later use, be sure to make them accessible to other users and observe the notes they contain.

With kind regards,

Your Beurer team

1. Getting to know your device

Check that the device packaging has not been tampered with and make sure that all contents are present. The wrist blood pressure monitor is used for non-invasive measurement and monitoring of adults' arterial blood pressure.

1. Displaying and deleting measurements .....22
2. Error messages/troubleshooting .....23
3. Cleaning and storing the device and cuff....23
4. Technical specifications....23

This allows you to quickly and easily measure your blood pressure and to display the last recorded measurement. A warning is issued for anyone suffering from cardiac arrhythmia.

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:

	Attention
	NoteNote 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
	Permissible storage temperature and humidity
Operating	Permissible operating temperature and humidity
	Protect from moisture
	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 administration).

• 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 pregnancy.
• 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.
• 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 avoid using an upper arm blood pressure monitor.

• 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.
• 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 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.
• Ensure that the cuff is not placed on an arm in which the arteries or veins are undergoing medical treatment, e.g. intravascular access 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 monitor switches off automatically if you do not press any buttons for 2 minutes.

• 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 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 electromagnetic 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 assistance.
• Choking hazard! Small children may swallow and choke on batteries. Store the 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 the batteries from excessive heat.

• Risk of explosion! Never throw batteries into a fire.
• Do not charge or short-circuit batteries.
• 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.

i 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.

3. Unit description

1. Scale for classifying the measurements
2. Display
3. Memory buttonM1
4. Memory button M2
5. START/STOP button ①
6. Battery compartment lid
7. Wrist cuff

1. Classification of measurements
2. Time and date
3. Systolic pressure
4. Diastolic pressure
5. Pump up, release air (arrow)
6. Calculated pulse value
7. Cardiac arrhythmia symbol 🎨 Pulse symbol ♥
8. Battery status indicator
9. User memory
10. Memory space number/memory display average value ( R), morning (Rf), evening (Pf)

1 2 # 38:88 88/88 10 9 8 7 6 < 188 5 3 4 88 88

4. Preparing for the measurement

Inserting the batteries

• Remove the battery compartment lid on the left side of the device.
• Insert two 1.5 V micro (alkaline type LR03) batteries. Make sure that the bat round. Do not use recharge
• Close the battery compartment lid again carefully.

Three identical line drawings of a mechanical component or housing, showing internal components and mounting brackets (no text or symbols)

If the battery change symbol ☐ is flashing and 86 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 mercury

Setting the hour format, date and time

This menu allows you to set the following functions, one after another.

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 ① 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 ①

The month flashes on the display.

- Select the month using the M1/M2 memory buttons and confirm with the START/STOP button ①.

The day flashes on the display.

- Select the day using the M1/M2 memory buttons and confirm with the START/STOP button①

If the hour format is set as 12h, the day/month display 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 ①.

The minutes flash on the display.

- Select the minute with the M1/M2 memory buttons and confirm with the START/STOP button ①.

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

5. Measuring blood pressure

Attaching the cuff

12 1cm

- 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.

Adopt the correct posture

• Before every measurement, relax for about five minutes. Otherwise 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. Al-

ways make sure that the cuff is at heart level. 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.

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 no start the blood pressure

monitor. All displays will illuminate briefly.

The blood pressure monitor will begin the measurement automatically after 3 seconds.

Silhouette of a person sitting with hands placed on a table, no text or symbols present

The measurement is taken during the inflation phase.

i You can cancel the measurement at any time by pressing the START/STOP button ⓘ

As soon as a pulse is found, the pulse symbol ♥ displayed.

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

- E_ appears if the measurement could not be 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 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 ☐ no switch off the blood pressure monitor. The measurement is then stored in the selected user memory. If you forget to turn off the device, it will switch off automatically 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 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 GP's instructions.

Classification of measurements:

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 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 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
Setting 3: severe hypertension	≥ 180 ≥ 110		seek medical attention
Setting 2: moderate hypertension	160–179	100–109	seek medical attention
Setting 1: mild hypertension	140–159	90–99	regular monitoring by doctor
High normal 130	-13985–89		regular monitoring by doctor
Normal 120–129	80–84 self-monitoring
Optimal <120<80	self-monitoring

Source: WHO, 1999 (World Health Organization)

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).
  i PresstheM1 button if you have selected user memory 1. Press the M2 memory button if you have selected user memory 2.

A flashes on the display.

The average value of all saved measured values in this user memory is displayed.

- Press the relevant memory button (M1 or M2).

AN flashes on the display.

The average value of the morning measurements for the last 7 days is displayed (morning: 5.00 a.m. - 9.00 a.m.).

- Press the relevant memory button (M1 or M2).

PA flashes on the display.

The average value of the evening measurements 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 ①

i 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.

• Start individual measurement access.
• Press and hold the M1 & M2 memory buttons for 5 seconds.

CL and 00 appear on the display.

All the values in the current user memory are deleted.

The device will then switch off automatically.

7. Error messages/troubleshooting

In the event of errors, the error message E_- appears on the display.

Error messages may appear if:

• It was not possible to record the pulse: E1;
• You move or speak during the measurement:: E2;
• The cuff is fastened too tightly or loosely: ☐;

- Errors occur during the measurement: E4;

- The pump pressure is higher than 300 mmHg: E5;

- The batteries are almost empty ☐ E6.

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

8. 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.

9. Technical specifications

Model no. BC 50

Measurement method Oscillometric, non-invasive blood pressure measurement on the wrist

Measurement range Cuff pressure 0-300 mmHg, Systolic 50-250 mmHg, Diastolic 30-200 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 94 mm x W 68 mm x H 20 mm

Weight Approximately 108 g (without batteries)

Cuff size 135 to 230 mm

Permissible operating conditions +5 °C to +40 °C, 15-93 % relative humidity (non-condensing) Permissible storage conditions -25 °C to +70 °C, ≤93 % relative humidity, 700-1050 hPa ambient pressure

Power supply 2 x 1.5V --- AAA batteries

Battery life For approx. 300 measurements, depending on levels of blood pressure and pump pressure
Accessories Instructions for use, 2 x 1.5V AAA batteries, 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 electromagnetic 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 Directive 93/42/EEC, the German Medical Devices Act (Medizinproduktgesetz) and the standards EN 1060-1 (non-invasive sphygmomanometers, Part 1: General requirements), EN 1060-3 (non-invasive sphygmomanometers, Part3: Supplementary requirements for electro-mechanical blood pressure measuring systems) and IEC 80601-2-30 (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 using the device for commercial 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.

FRANÇAIS

Sommaire

Silhouette of a person sitting at a desk with hands placed on the right, no text or symbols present

1 2 3 4 M1 M2 5 6 7 FUS device DIA device

Three identical line drawings of a cylindrical mechanical component, showing internal structure and mounting holes (no text or symbols)

Silhouette of a person sitting at a desk with hands placed on the right, no text or symbols present

Three identical line drawings of a mechanical component or bracket, showing internal features without any text or symbols.

Silhouette of a person sitting at a desk with hands placed on the phone and heart symbols on their arms (no text or labels)

Three identical line drawings of a mechanical component or bracket, showing internal features without any text or symbols.

Silhouette of a person sitting with heart symbols on her hand, holding an object (no text or symbols present)

Three identical line drawings of a cylindrical object with a central rod, shown from different angles (no text or symbols)

Silhouette of a person with heart symbol resting on arm and hand, no text or symbols present

Three identical line drawings of a mechanical component or housing, showing internal components and mounting brackets (no text or symbols)

Silhouette of a person sitting at a desk with hands placed on the phone and heart symbols on the chest (no text or labels)

Guidance and manufacture's declaration – electromagnetic emissions – for all EQUIPMENT and SYSTEMS

Guidance and manufacture's declaration – electromagnetic emission
The BC50 blood pressure monitor is intended for use in the electromagnetic environment specified below. The customer of the user of the BC50 blood pressure monitor should assure that it is used in such and environment.
Emission test	Compliance	Electromagnetic environment – guidance
RF emissions CISPR 11	Group 1 The	BC50 blood pressure monitor uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emission CISPR 11 Class B		The BC50 blood pressure monitor is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Guidance and manufacture's declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS

Guidance and manufacture's declaration – electromagnetic immunity
The BC50 blood pressure monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the BC50 blood pressure monitor should assure that it is used in such an environment.
Immunity test IEC 60601	test level	Compliance level	Electromagnetic environment – guidance
Electrostatic discharge (ESD)IEC 61000-4-2	± 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 fieldIEC 61000-4-8	3 A/m 3 A/m		Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Guidance and manufacture's declaration – electromagnetic immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacture's declaration – electromagnetic immunity
The BC50 blood pressure monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the BC50 blood pressure monitor should assure that it is used in such an environment.
Immunity test	EC 60601 test level	Compliance level	Electromagnetic environment – guidance
Conducted RF IEC 61000-4-6Radiated RF IEC 61000-4-3	3 Vrms150 kHz to 80 MHz3 V/m80 MHz to 2.5 GHz	3 Vrms3 V/m	Portable and mobile RF communications equipment should be used no closer to any part of the BC50 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 = [ 3.5V_1 ] d = [ 3.5E_1 ] to 800 MHz d = [ 7E_1 ] 00 MHz to 2.5 GHzWhere 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, ^a should be less than the compliance level in each frequency range. ^b Interference may occur in the vicinity of equipment marked with the following symbol:[IMAGE]
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 affected by absorption and reflection from structures, objects and people.
^a 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 BC50 blood pressure monitor is used exceeds the applicable RF compliance level above, the BC50 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 BC50 blood pressure monitor. ^b 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 – for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING

Recommended separation distances between portable and mobile RF communications equipment and the BC50 blood pressure monitor
The BC50 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 BC50 blood pressure monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the BC50 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 = [ 3.5V_1 ]	80 MHz to 800 MHz d = [ 3.5E_1 ]	800 MHz to 2.5 GHz d = [ 7E_1 ]
0.01 0.117 0.117 0.234
0.1 0.370 0.370 0.740
1 1.170 1.170 2.340
10 3.700 3.700 7.400
100 11.7 11.7 23.4
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 affected by absorption and reflection from structures, objects and people.

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

CE 0483