Beurer BC 50: ENGLISH

ENGLISH: Beurer BC 50

ENGLISH

Contents

1. Getting to know your device ............................................14

6. Displaying and deleting measurements ...........................22

2. Important notes ................................................................14

7. Transferring measurements ..............................................23

3. Unit description ................................................................17

8. Error messages/troubleshooting ......................................23

4. Preparing for the measurement ........................................18

9. Cleaning and maintenance ...............................................23

5. Measuring blood pressure ................................................19

10. Technical specifications .................................................24

Dear customer,

The wrist blood pressure monitor is used to carry out non-

Thank you for choosing one of our products. Our name stands

invasive measurement and monitoring of arterial blood pressure

for high-quality, thoroughly tested products for applications in

values in human adults. This allows you to quickly and easily

the areas of heat, gentle therapy, blood pressure/diagnosis,

measure your blood pressure, save the measurements and

weight, massage,

display the development of the measurements. You are also

beauty and air.

warned of possible existing cardiac arrhythmia.

Please read these instructions for use carefully and keep them

The recorded values are classified according to the WHO guide-

for later use, be sure to make them accessible to other users

lines and evaluated graphically.

and observe the notes they contain.

Store these instructions for use for future reference and make

them accessible to other users.

With kind regards,

Your Beurer team

2. Important notes

1. Getting to know your device

Signs and symbols

Check that the packaging of the Beurer BC80 blood pressure

The following symbols are used in these instructions for use,

monitor has not been tampered with and make sure that all the

on the packaging and on the type plate for the device and the

required contents are present.

accessories:

14

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

15

%

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-

Permissible storage temperature and

70°C

humidity

ministration).

-25°C

Do not use the blood pressure monitor on newborns or

patients with pre-eclampsia. We recommend consulting a

Operating

Permissible operating temperature and

doctor before using the blood pressure monitor during preg-

40°C

humidity

nancy.

5°C

RH 15-93%

In the case of restricted circulation on the arm as a result of

chronic or acute vascular diseases (including vascular con-

Protect from moisture

striction), the accuracy of the wrist measurement is limited.

In this case you should avoid using an upper arm blood pres-

sure monitor.

SN

Serial number

Cardiovascular diseases may lead to incorrect measurements

Instructions for storage and maintenance

or have a detrimental effect on measurement accuracy. The

same also applies to very low blood pressure, diabetes, circu-

The blood pressure monitor is made from precision and elec-

latory disorders and arrhythmias as well as chills or shaking.

tronic components. The accuracy of the measurements and

The blood pressure monitor must not be used in connection

service life of the device depend on its careful handling:

with a high-frequency surgical unit.

Protect the device from impacts, humidity, dirt, marked

Only use the unit on people who have the specified wrist

temperature fluctuations and direct sunlight.

measurement for the device.

Do not drop the device.

Please note that when inflating, the functions of the limb in

Do not use the device in the vicinity of strong electromag-

question may be impaired.

netic fields and keep it away from radio systems or mobile

During the blood pressure measurement, the blood circula-

telephones.

tion must not be stopped for an unnecessarily long time. If

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

the device malfunctions, remove the cuff from the arm.

We recommend that the batteries be removed if the device

Do not allow sustained pressure in the cuff or frequent meas-

will not be used for a prolonged period of time.

urements. The resulting restriction of the blood flow may

Notes on batteries

cause injury.

Ensure that the cuff is not placed on an arm in which the

Swallowing batteries can be extremely dangerous. Keep the

arteries or veins are undergoing medical treatment, e.g. in-

batteries and products out of the reach of small children. If

travascular access or therapy, or an arteriovenous (AV) shunt.

a battery is swallowed, seek medical attention immediately.

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

Batteries must not be recharged, taken apart, thrown into an

tectomy.

open fire or short circuited.

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

If the batteries are empty or you do not intend to use the de-

injury.

vice for longer periods, remove the batteries from the device.

The blood pressure monitor can only be operated with bat-

This prevents damage which could occur when the batteries

teries.

expire. Always replace all batteries at the same time.

To conserve the batteries, the monitor switches off automati-

Do not use different types of batteries, different brands or

cally if you do not press any buttons for 2 minutes.

batteries with different capacities. Use alkaline batteries.

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.

16

3. Unit description

Instructions for repairs and disposal

1. WHO indicator

Batteries do not belong in household waste. Please dispose

2. USB interface

of empty batteries at the collection points intended for this

3. Display

purpose.

4. Positioning display (heart level)

Do not open the device. Failure to comply will result in voiding

5. Memory button M1

of the warranty.

6. Memory button M2

Do not repair or adjust the device yourself. Proper operation

7. START/STOP button

can no longer be guaranteed in this case.

8. Battery compartment lid

Repairs must only be carried out by Customer Services or

9. Wrist cuff

authorised suppliers. Before making a claim, please check

the batteries first and replace them if necessary.

3

Please dispose of the device in accordance with EC

2

Directive WEEE (Waste Electrical and Electronic

4

5

Equipment).

1

If you have any questions, please contact the local

authorities responsible for waste disposal.

M1

O

k

M2

6

7

8

9

17

Information on the display:

1. WHO classification

2. Time and date

3. Systolic pressure

4. Diastolic pressure

5. Resting indicator (symbol is inactive)

6. Cardiac arrhythmia symbol

Pulse symbol

7. Calculated pulse value

8. User memory /

9. Pump up, release air (arrow)

10. Memory space number/memory display

average value (

A

), morning (

AM

), evening (

PM

)

11. Battery status indicator

1 2

11

3

10

9

8

4

567

18

OK

!

4. Preparing for the measurement

Inserting the batteries

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

E6

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.

Used batteries should not be disposed of in normal household

waste. Dispose of them via your electronics retailer or your lo-

cal recycling point. You are legally obligated to do so.

Note: The codes below are printed on batter-

ies containing harmful substances: Pb: battery

contains lead, Cd: battery contains cadmium,

Hg: battery contains mercury.

Setting the hour format, date and time

The day flashes on the display.

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

Select the day using the M1/M2 memory buttons and

another.

confirm with the START/STOP button .

Hour format

Date

Time

If the hour format is set as 12h, the day/month dis-

play sequence is reversed.

It is essential to set the date and time. Otherwise, you will not

Time

be able to save your measured values correctly with a date and

time and access them again later.

The hours flash on the display.

If you press and hold the M1 or M2 memory button, you

Select the hour using the M1/M2 memory buttons

can set the values more quickly.

and confirm with the START/STOP button .

Hour format

The minutes flash on the display.

Press and hold the START/STOP button

Select the minute with the M1/M2 memory but-

for 5 seconds.

tons and confirm with the START/STOP button

.

Select the desired hour format using the M1/

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

M2 memory buttons and confirm with the

tomatically.

START/STOP button .

5. Measuring blood pressure

Date

Attaching the cuff

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

.

19

1 2 3

1 cm

O

k

M2

M1

k

O

M2

M1

O

k

M2

M1

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

Press the START/STOP button to

upper edge of the device is positioned approx. 1 cm under-

start the blood pressure monitor. All

neath the heel of the hand.

displays will illuminate briefly.

The cuff must be fitted tightly around the wrist, but must not

OK

!

The blood pressure monitor will begin the

constrict.

measurement automatically after 3 sec-

Adopt the correct posture

onds.

The measurement is taken during the in-

Before every measurement, relax for about five minutes. Oth-

flation phase.

erwise deviations can occur.

You can take the measurement

You can cancel the measurement at any time by pressing

while sitting or lying. To take

the START/STOP button

.

your blood pressure, make sure

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

you are sitting comfortably with

The systolic pressure, diastolic pressure

your arms and back leaning on

and pulse rate measurements are

something. Do not cross your

displayed.

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

E

_ appears if the measurement could not be performed prop-

the device to additionally assist you. It signals the correct

erly. Observe the chapter on error messages/

position of the blood pressure monitor. You are in the right

troubleshooting in these instructions for use and

position if you can see O.K. on the display.

repeat the measurement.

To avoid falsifying the measurement, it is important to remain

Now select the desired user memory by pressing

still during the measurement and not to speak.

the M1 or M2 memory buttons. If you do not select a user

Performing the blood pressure measurement

memory, the measurement is stored in the most recently used

user memory. The relevant symbol M1 or M2 appears in the

As described above, attach the cuff and adopt the posture in

display.

which you want to perform the measurement.

Press the START/STOP button to switch off the blood

pressure monitor. The measurement is then stored in the

selected user memory.

20

If you forget to turn off the device, it will switch off auto-

However, these standard values serve only as a general guide-

matically after approx. 3 minutes. In this case too, the value

line, as the individual blood pressure varies in different people

is stored in the selected or most recently used user memory.

and different age groups etc.

Wait at least 5 minutes before taking another

It is important to consult your doctor regularly for advice. Your

measurement.

doctor will tell you your individual values for normal blood pres-

sure as well as the value above which your blood pressure is

Evaluating results

classified as dangerous.

Cardiac arrhythmia:

The bar chart on the display and the scale on the unit show

This device can identify potential disruptions of the heart

which category the recorded blood pressure values fall into. If

rhythm when measuring and if necessary, indicates this after

the values of systole and diastole fall into two different WHO

the measurement with the symbol .

categories (e.g. systole in the ‘High normal’ category and di-

This can be an indicator for arrhythmia. Arrhythmia is an illness

astole in the ‘Normal’ category), the graphical WHO classifica-

in which the heart rhythm is abnormal because of flaws in the

tion on the device always shows the higher category; for the

bioelectrical system that regulates the heartbeat. The symp-

example given this would be ’High normal’.

toms (skipped or premature heart beats, pulse being slow or

Blood pres-

Systole

Diastole

Action

too fast) can be caused by factors such as heart disease, age,

sure value

(in mmHg)

(in mmHg)

physical make-up, excess stimulants, stress or lack of sleep.

category

Arrhythmia can only be determined through an examination

Grade 3:

seve-

seek medical at-

by your doctor.

≥180 ≥110

re hypertension

tention

If the symbol is shown on the display after the measure-

ment has been taken, repeat the measurement. Please ensure

Grade 2:

mo-

seek medical at-

derate hyper-

160-179 100-109

that you rest for 5 minutes beforehand and do not speak or

tention

tension

move during the measurement. If the symbol appears fre-

quently, please consult your doctor. Self-diagnosis and treat-

Grade 1:

mild

regular monitoring

140-159 90-99

hypertension

by doctor

ment based on the measurements can be dangerous. Always

follow your GP’s instructions.

regular monitoring

High normal 130-139 85-89

by doctor

WHO classification:

Normal 120-129 80-84 self-monitoring

In accordance with the guidelines/definitions of the World Heath

Organization and the latest findings, the measurements can

Optimal <120 <80 self-monitoring

be classified and assessed according to the following table.

Source: WHO, 1999

21

6. Displaying and deleting measurements

AM

flashes on the display.

User memory

The average value of the morning meas-

The results of every successful measurement are stored

urements for the last 7 days is displayed

together with the date and time. If there are more than 60

(morning: 5.00 a.m. – 9.00 a.m.).

measurements, the oldest measurements are lost.

Press the relevant memory button

(M1 or M2).

To access memory recall mode, press the M1 or M2

memory button to select your desired user memory ( ).

PM

flashes on the display.

To view the measurements for user

The average value of the evening meas-

memory

press the M1 memory

urements for the last 7 days is displayed

button.

(evening: 6.00 p.m. – 8.00 p.m.).

To view the measurements for user

memory

, press the M2 memory

Individual measured values

button.

When the relevant memory button

Your last measurement will appear on

(M1 or M2) is pressed again, the last

the display.

individual measurement is displayed

Average values

(in this example, measurement 03).

Press the relevant memory button (M1 or M2).

When the relevant memory button

Press the M1 button if you have selected user memory

(M1 or M2) is pressed again, you can view your individual

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

measurements.

memory 2.

To switch the device off again, press the START/STOP

A

flashes on the display.

button .

The average value of all saved meas-

You can exit the menu at any time by pressing the

ured values in this user memory is

START/STOP button .

displayed.

Deleting measured values

Press the relevant memory button

(M1 or M2).

To clear the memory of the relevant user memory, you

must first select a user memory.

22

Start individual measurement access.

8. Error messages/troubleshooting

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

In the event of errors, the error message

E

_

appears on the

onds.

display.

Error messages may appear if:

CL

and

00

appear on the display.

It was not possible to record the pulse:

E 1

;

All the values in the current user memory

You move or speak during the measurement::

E2

;

are deleted.

The cuff is fastened too tightly or loosely:

E3

;

The device will then switch off automati-

Errors occur during the measurement:

E4

;

cally.

The pump pressure is higher than 300 mmHg:

E5

;

The batteries are almost empty

E6

.

In such cases, repeat the measurement. Ensure that you

7. Transferring measurements

do not move or speak. If necessary, reinsert or replace the

Connect the blood pressure monitor to your PC using the

batteries.

USB cable.

No data transfer may be launched whilst performing a

9. Cleaning and maintenance

measurement.

Clean your blood pressure monitor carefully using a slightly

damp cloth only.

PC

is shown on the display. Begin the data

Do not use any cleaning agents or solvents.

transfer in the “HealthManager” PC software.

Under no circumstances should you hold the unit under

During the data transfer, an animation is

water, as this can cause liquid to enter and damage the

shown on the display. A successful data

unit.

transfer is displayed as in figure 1. If the data

Never place any heavy objects on the device.

transfer is unsuccessful, an error message

f

igure 1

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,

f

igure 2

the blood pressure monitor switches itself off

automatically.

23

10. Technical specifications

Accessories Instructions for use, 2 x 1.5V AAA bat-

Model no. BC 80

teries, storage box

Measurement method Oscillometric, non-invasive blood pres-

Classification Internal supply, IPX0, no AP or APG,

sure measurement on the wrist

continuous operation, application part

type BF

Measurement range Cuff pressure 0-300 mmHg,

Systolic 50-250 mmHg,

This device is in line with European Standard EN 60601-1-2

Diastolic 30-200 mmHg,

and is subject to particular precautions with regard to electro

-

Pulse 40-180 beats/minute

magnetic compatibility (EMC). Please note that portable and

Display accuracy Systolic ± 3 mmHg,

mobile HF communication systems may interfere with this

Diastolic ± 3 mmHg,

Pulse ± 5 % of the value shown

unit. More details can be requested from the stated Customer

Services address or found at the end of the instructions for

Measurement inac-

Max. permissible standard deviation

use.

curacy

according to clinical testing:

Systolic 8 mmHg /

This device corresponds to the EU Medical Devices Directive

Diastolic 8 mmHg

93/42/EC, the German Medical Devices Act (Medizinproduk-

tgesetz) and the standards EN1060-1 (non-invasive sphyg-

Memory 2 x 60 memory spaces

momanometers, Part 1: General requirements), EN1060-3

Dimensions L 97 mm x W 68 mm x H 22 mm

(non-invasive sphygmomanometers, Part3: Supplementary

Weight Approximately 108 g (without batteries)

requirements for electro-mechanical blood pressure measur-

Cuff size 135 to 230 mm

ing systems) and IEC80601-2-30 (Medical electrical equip-

Permissible operating

+5 °C to +40 °C, 15-93 % relative hu

-

ment – Part 2-30: Particular requirements for the basic safety

conditions

midity (non-condensing)

and essential performance of automated non-invasive sphyg-

momanometers).

Permissible storage

-25 °C to +70 °C, 10-93 % relative hu-

conditions

midity, 700-1050 hPa ambient pressure

The accuracy of this blood pressure monitor has been care-

fully checked and developed with regard to a long useful life.

Power supply 2 x 1.5V

AAA batteries

If using the device for commercial medical purposes, it must

Battery life For approx. 300 measurements, de-

be regularly tested for accuracy by appropriate means. Pre-

pending on levels of blood pressure

cise instructions for checking accuracy may be requested

and pump pressure

from the service address.

24