Beurer BC 19: ENGLISH

pressure, diabetes, circulatory disorders and arrhyth-

• The device is only intended for the purpose described in

mias as well as chills or shaking.

these instructions for use. The manufacturer is not liable

•

The blood pressure monitor must not be used in con-

for damage resulting from improper or careless use.

nection with a high-frequency surgical unit.

Storage and Care

•

Only use the unit on people who have the specified

wrist measurement for the device.

•

The blood pressure monitor is made up of precision

•

Please note that when inflating, the functions of the

electronic components. Accuracy of readings and the

limb in question may be impaired.

instrument’s service life depend on careful handling.

•

During the blood pressure measurement, blood circu-

– You should protect the device from impact, moisture,

lation must not be stopped for an unnecessarily long

dirt, major temperature fluctuations and direct expo-

time. If the device malfunctions, remove the cuff from

sure to the sun’s rays.

the arm.

– Never drop the device.

•

Do not allow sustained pressure in the cuff or frequent

– Do not use near strong electromagnetic fields, i.e.

measurements. The resulting restriction of the blood

keep it away from any radio systems and mobile

flow may cause injury.

phones.

•

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

– Only ever use the cuffs provided with the monitor

the arteries or veins are undergoing medical treatment,

or original replacement cuffs. Otherwise erroneous

e.g. intravascular access or therapy, or an arteriove-

results will be recorded.

nous (AV) shunt.

•

Do not press any buttons until the cuff is in position.

•

Do not use the cuff on people who have undergone a

•

If the instrument is not used for any length of time, we

mastectomy.

recommend removing the batteries.

•

Do not place the cuff over wounds as this may cause

further injury.

Advice on batteries

•

The blood pressure monitor can only be operated with

•

Batteries can be fatal if swallowed. You should there-

batteries.

fore store the batteries and products where they are

•

To conserve the batteries, the monitor switches off

automatically if no buttons are pressed for one minute.

16

inaccessible to small children. If a battery has been

the batteries and replace them if necessary prior to

swallowed, call a doctor immediately.

making any complaint.

•

Batteries should not be charged or reactivated with

•

The appliance should be disposed of according to

any other means, nor should they be taken apart,

Regulation-WEEE (Waste Electrical and Elec-

thrown in the fire or short-circuited.

tronic Equipment). In case of queries, please

•

Remove the batteries from the instrument if they are

contact the municipal authorities responsible for

worn out or if you are not going to use the instrument

waste disposal in your area.

for any length of time. This prevents any damage as a

3. Unit description

result of leakage. Always replace all the batteries at the

same time.

8

1

. Battery cover

7

•

Never use different types of battery, battery brands or

2

. Display

4

batteries with different capacities. You should prefer-

1

3

.

Loudspeaker

ably use alkaline batteries.

4

. START/STOP

2

button

Repair and disposal

5

. Memory button M

•

Batteries do not belong in domestic refuse. Used bat-

3

6

. Wrist cuff

teries should be disposed of at the collection points

7

. Volume button

5

provided.

louder +/quieter -

6

•

Never open the instrument. If these instructions are

8. WHO - LED

not heeded, the warranty will be null and void.

•

Never attempt to repair the instrument or adjust it

yourself. We can no longer guarantee perfect function-

ing if you do.

•

Repairs may only be performed by Beurer Customer

Service or authorized dealers. However, always check

17

Icons in the display:

Once batteries have been removed from the device, the

10

1. Systolic pressure

time must be reset. Any measurement results that have

9

2. Diastolic pressure

been stored are however retained.

8

1

3. Pulse rate

Note: You will find these markings on batte

4. Pulse icon

/ Cardiac

ries containing harmful substances: Pb =

arrhythmia icon

7

battery containing lead, Cd = battery con-

2

5. Number of memory space

taining cadmium, Hg = battery containing

6. Time and date

mercury.

6

3

7. Inflate/deflate arrow

Setting date and time

45

8. ‘Change battery’ icon

It is vital to set the date and time. This is the only way

9. WHO classification

that measurements can be saved and recalled with the

10. Memory Zones

correct date and time.

4. Prepare measurement

The time is shown in 24 hour format. The device also has

five languages. The device is set to German on delivery.

Inserting battery

Proceed as follows to set the date, time and language:

•

Remove the battery cover (left side of the unit).

•

Press the memory key M for over 5 seconds.

•

Insert two 1.5 V micro batteries (alkaline, type LR 03).

•

The year starts flashing. Use the +/- key to set the year

Make absolutely sure that you insert the batteries with

and confirm with the memory key M.

the correct polarity as marked. Do not use recharge-

•

Set the year, month, day, hour and minute and confirm

able batteries.

in each case with the memory key M.

•

Replace the battery cover carefully.

•

After setting the date and time you can set the lan-

If the ‘change battery’ icon

is displayed, measure-

guage.

ment is no longer possible and you must replace all

•

Use the + and - volume keys to select the following

the batteries.

languages: L1 = German, L2 = English, L3 = French,

L4 = Spanish, L5 = Russian, L0 = no language. Con-

firm your selection with the memory key M.

18

•

You can then set the volume of the selected language:

•

Bare your left wrist, making sure that the circulation in

Vol 3 = high, Vol 2 = medium, Vol 1 = low. Confirm

the arm is not restricted by any clothes etc. that are

your selection with the memory key M.

too tight. Position the cuff on the inside of your wrist.

Note: Language off means that voice output is

•

Fasten the cuff with the Velcro fastening so that the

not selected and the measurement value will not be

upper edge of the monitor is positioned approx. 1 cm

announced.

below the ball of your thumb.

•

The cuff has to be fitted tightly around the wristbut

Select memory

should not constrict it.

Switch on the device with the

button. When the

device is switched off only the clock in the display is

Important: The instrument should only be operated with

shown. After the announcement you can select the

the original cuff.

desired memory space by pressing the + or - volume

Correct posture

button.

•

Rest for approx. 5 minutes before each measurement.

Two memories with 60 memory spaces each are avail-

Otherwise there may be divergences.

able to save the measurement results of two different

•

You can perform the measurement

people separately or to save morning and evening meas-

while sitting or lying. To carry out a

urement values separately.

blood pressure measurement, make

5. Measuring blood pressure

sure you are sitting comfortably with

your arms and back leaning on

Positioning cuff

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.

•

In order not to distort the result, it is important to keep

still during the measurement and not talk.

19

Measuring blood pressure

instructions on error messages/troubleshooting and

•

Put on the cuff as described previously and assume

repeat the measurement.

the position in which you want to carry out the meas-

•

The test result is saved automatically.

urement.

Evaluating results

•

Start the measurement process by pressing START/

Cardiac arrhythmia:

STOP button . After checking the display with all

This instrument can identify possible cardiac arrhythmia

digits lighting up, the monitor will automatically inflate.

disorders during measurement and if necessary indi-

Following the self-test, during which all display ele-

cates the measurement with the flashing icon

.

ments briefly appear, the measurement begins. Dur-

This may be an indicator for arrhythmia. Arrhythmia

ing inflation the device already determines measured

is a condition where the heart rhythm is abnormal as

values used to estimate the required inflation pressure.

a result of defects in the bioelectrical system control-

If this pressure is insufficient, the device automatically

ling the heart beat. The symptoms (omitted or prema-

inflates by another 40 mmHg (Real Fuzzy Logic).

ture heart beats, slow or excessively fast heart rate) may

•

Then the pressure in the cuff is slowly released and

be caused, among other things, by heart disease, age,

the pulse is measured.

physical predisposition, excessive use of stimulants,

•

When the measurement has been completed, the

stress or lack of sleep. Arrhythmia can only be ascer-

remain ing air pressure is released very quickly. The

tained through examination by your doctor.

pulse, the systolic and the diastolic blood pressure are

Repeat the measurement if the flashing icon is

displayed.

displayed after the measurement. Please note that you

•

You can adjust the volume during the announcement

should rest for 5 minutes between measurements and

by pressing + and -.

not talk or move during the measurement. If the icon

•

You can interrupt measurement at any time by press-

appears often, please contact your doctor. Any

ing the START/STOP button .

self-diagnosis and treatment based on the test results

•

_ appears if it has not been possible to perform the

may be dangerous. It is vital to follow your doctor’s

measurement properly. Observe the section in these

instructions.

20

WHO classification:

Have it che-

In accordance with the guidelines/definitions of the

High-normal

cked regu-

130 -139 85 - 89

World Heath Organization and the latest findings, the

(Green)

larly by doc-

measurements can be classified and assessed accor-

tor

ding to the following table.

Check it

However, these standard values serve only as a general

Normal (Green) 120 -129 80 - 84

yourself

guideline, as the individual blood pressure varies in diffe-

Check it

rent people and different age groups etc.

Optimal (Green) <120 <80

yourself

It is important to consult your doctor regularly for advice.

Your doctor will tell you your individual values for normal

Source: WHO, 1999

blood pressure as well as the value above which your

blood pressure is classified as dangerous.

The bar graph in the display and the scale on the unit

indicate the range of the blood pressure which has been

Range of blood

Systolic

Diastolic

Measure

recorded. An accoustic evaluation of your measurement

pressure values

(in mmHg)

(in mmHg)

also follows.

Grade 3:

If the values for systolic and diastolic pressure are in

Seek medical

Severe hyperten-

≥180 ≥110

two different WHO ranges (e.g. systolic in the high-nor-

advice

sion (Red)

mal range and diastolic pressure in the normal range)

Grade 2:

the graphic WHO classification on the unit indicates the

Seek medical

Moderate hyper-

160 -179 100 -109

higher range (high-normal in the example described).

advice

tension (Orange)

6. Saving, retrieving and deleting results

Have it che-

Grade 1:

•

The results of each successful measurement are

cked regu-

Mild hypertension

140 -159 90 - 99

stored together with date and time. With more than

larly by doc-

(Yellow)

60 items of measured data, the earliest items of data

tor

measured are lost.

21

•

In order to retrieve measurement results again, press

•

there is a system or device error (

ErA

,

, Er7

or

the memory key M. Initially, the average value of the

Er8

appears on the display)

last three blood pressure readings is displayed (Dis-

•

the batteries are almost empty .

play ). Press the memory key M again to display the

In the above cases, you must repeat the measurement.

latest measurements with date, time and graphic WHO

Make sure that the cuff tube is properly inserted and that

classification and to hear the values announced. You

you do not move or talk.

can adjust the volume during the announcement by

Re-insert the batteries if necessary, or else replace

pressing the volume key + and -.

them.

•

You can clear the memory by pressing and holding +

and - simultaneously for 5 seconds after pressing the

Technical alarm – description

memory key M and selecting the user.

Should the recorded blood pressure (systolic or diasto-

•

If you wish to change the user memory, see “Select

lic) lie outside the limits specified in the section “Techni-

memory”.

cal specifications”, the technical alarm will appear on the

display indicating either “

” or “

Lo

”. In such cases, you

7. Error messages/troubleshooting

should seek medical assistance and check the accuracy

In case of faults, the _ message appears in the display.

of your procedure.

Error messages may appear if:

The limit values for the technical alarm are factory set

•

systolic or diastolic pressure could not be measured

and cannot be adjusted or deactivated. These alarm limit

( or appears on the display)

values are accorded second priority under the standard

•

systolic or diastolic pressure was outside the measure-

IEC 60601-1-8.

ment range ( or

Lo

appears on the display)

The technical alarm is a non-locking alarm and must not

•

the cuff is fastened too tightly or loosely (

Er3

or

Er4

be reset. The signal shown on the display will disappear

appears on the display)

automatically after about 8 seconds.

•

the pump pressure is higher than 300 mmHg (

Er5

appears on the display)

•

pumping up takes longer than 160 seconds (

Er6

appears on the display)

22

8. Cleaning and storing the instrument

Dimensions L 85 mm x W 70 mm x H 31 mm

•

Clean your blood pressure monitor carefully using a

Weight Approx. 140 g (without batteries)

slightly damp cloth only.

Cuff size 14.0 to 19.5 mm

•

Do not use any detergents or solvents.

•

Never hold the instrument under water as otherwise

Permissible operating

+10 °C to +40 °C, ≤ 85 % relative

liquid can penetrate and damage the instrument.

conditions

air humidity (non-condensing)

•

Never place any heavy objects on the instrument.

Permissible storage

-20 °C to +55 °C, ≤85 % relative

conditions

air humidity, 800-1050 hPa ambi-

9. Technical details

ent pressure

Model no. BC 19

Power supply

2 x 1,5 V

AAA batteries

Measurement

Oscillometric, non-invasive blood

Battery life For approx. 250 measurements,

method

pressure measurement on the

depending on the blood pressure

wrist

level and/or pump pressure

Measurement range Cuff pressure 0 – 300 mmHg,

Accessories Instruction for use, 2 x 1.5 V AAA

systolic 60 – 260 mmHg,

batteries, storage box

diastolic 40 – 199 mmHg,

Classification Internal supply, continuous oper-

Pulse 40 –180 beats/minute

ation, type BF applied part, IPX0,

Display accuracy Systolic ± 3 mmHg,

no AP or APG

diastolic ± 3 mmHg,

pulse ± 5 % of the value shown

Technical information is subject to change without notifi-

Measurement inac-

Max. permissible standard devia-

cation to allow for updates.

curacy

tion according to clinical testing:

•

This unit is in line with European Standard EN 60601-

systolic 8 mmHg /diastolic

1-2 and is subject to particular precautions with regard

8 mmHg

to electromagnetic compatibility (EMC). Please note

Memory 2 x 60 memory spaces

that portable and mobile HF communication sys-

23

tems may interfere with this unit. More details can be

requested from the stated Customer Service address

or found at the end of the instructions for use.

•

This device is in line with the EU Medical Devices

Directive 93/42/EC, the “Medizinproduktegesetz”

(German Medical Devices Act) and the standards

EN1060-1 (non-invasive sphygmomanometers, Part 1:

General requirements), EN1060-3 (non-invasive

sphygmomanometers, Part 3: Supplementary require-

ments for electro-mechanical blood pressure measur-

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

equipment – Part 2 – 30: Particular requirements for the

safety and essential performance of automated non-

invasive blood pressure monitors).

•

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. Precise instructions for checking

accuracy may be requested from the service address.

24