Beurer BC 31: ENGLISH

ENGLISH: Beurer BC 31

ENGLISH

Dear Customer,

2. Important information

thank you for choosing one of our products. Our name

Signs and symbols

stands for high-quality, thoroughly tested products for

the applications in the areas of heat, weight, blood pres-

The following symbols are used in these instructions

sure, body temperature, pulse, gentle therapy, massage

for use, on the packaging and on the type plate for the

and air.

device and accessories:

Please read these instructions for use carefully and keep

Caution

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

other users and observe the information they contain.

Best regards,

Note

Your Beurer Team

Note on important information

1. Getting to know your instrument

Follow instructions for use

The wrist blood pressure monitor is used for non-inva-

sive measurement and monitoring of adults’ arterial

blood pressure.

Type BF applied part

You can use it to measure your blood pressure quickly

and easily, storing the results and displaying the pro-

gression of readings. A warning is issued for anyone

Direct current

suffering from cardiac arrhythmia.

Disposal in accordance with EC Direc-

The values determined are classified and graphically

tive 2002/96/EC – WEEE (Waste Electri-

evaluated according to WHO guidelines.

cal and Electronic Equipment).

Keep these instructions carefully for further use and

also let other users have access to them.

13

Do not take a measurement within 30 minutes after

Manufacturer

eating, drinking, smoking or exercising.

Repeat the measurement if you are unsure of the

Storage

Permissible storage temperature and

measured value.

55°C

humidity

The measurements taken by you are for your infor-

-20°C

RH ≤95%

mation only – they are not a substitute for a medi-

Operating

Permissible operating temperature and

cal examination! Discuss the measurements with your

40°C

humidity

doctor, and never base any medical decisions on them

5°C

RH ≤90%

(e.g. medicines and their administration)!

Do not use the blood pressure monitor on newborns,

Keep dry

pregnant women or patients with preeclampsia.

In the case of restricted circulation on the arm as a

result of chronic or acute vascular diseases (including

SN Serial number

vascular constriction), the accuracy of the wrist meas-

The CE labelling certifies that the prod-

urement is limited. In this case you should avoid using

uct complies with the essential require-

an upper arm blood pressure monitor.

0483

ments of Directive 93/42/EEC on medi-

Cardiovascular diseases may lead to incorrect meas-

cal products.

urements or have a detrimental effect on measurement

accuracy. The same also applies to very low blood

Advice on use

pressure, diabetes, circulatory disorders and arrhyth-

mias as well as chills or shaking.

In order to ensure comparable values, always measure

The blood pressure monitor must not be used in con-

your blood pressure at the same time of day.

nection with a high-frequency surgical unit.

Before every measurement, relax for about five minutes.

Only use the unit on people who have the specified

If you want to perform several measurements on the

wrist measurement for the device.

same person, wait five minutes between each meas-

Please note that when inflating, the functions of the

urement.

limb in question may be impaired.

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During the blood pressure measurement, blood circu-

Storage and Care

lation must not be stopped for an unnecessarily long

time. If the device malfunctions, remove the cuff from

The blood pressure monitor is made up of precision

the arm.

electronic components. Accuracy of readings and the

Do not allow sustained pressure in the cuff or frequent

instrument’s service life depend on careful hand ling.

measurements. The resulting restriction of the blood

You should protect the device from impact, moisture,

flow may cause injury.

dirt, major temperature fluctuations and direct expo-

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

sure to the sun’s rays.

the arteries or veins are undergoing medical treatment,

– Never drop the device.

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

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

venous (AV) shunt.

keep it away from any radio systems and mobile

Do not use the cuff on people who have undergone a

phones.

mastectomy.

Only ever use the cuffs provided with the monitor

Do not place the cuff over wounds as this may cause

or original replacement cuffs. Otherwise erroneous

further injury.

results will be recorded.

The blood pressure monitor can only be operated with

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

batteries.

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

To conserve the batteries, the monitor switches off

recommend removing the batteries.

automatically if no buttons are pressed for one minute.

Advice on batteries

The device is only intended for the purpose described

in these instructions for use. The manufacturer is not

Batteries can be fatal if swallowed. You should there-

liable for damage resulting from improper or careless

fore store the batteries and products where they are

use.

inaccessible to small children. If a battery has been

swallowed, call a doctor immediately.

Batteries should not be charged or reactivated with

any other means, nor should they be taken apart,

thrown in the fire or short-circuited.

15

Remove the batteries from the instrument if they are

3. Unit description

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

1. Display

1

2

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

2. Memory button M

result of leakage. Always replace all the batteries at the

3

3. Wrist cuff

5

same time.

4. START/STOP

Never use different types of battery, battery brands or

5. Battery cover

batteries with different capacities. You should prefer-

ably use alkaline batteries.

4

Repair and disposal

Batteries do not belong in domestic refuse. Used bat-

Icons in the display:

teries should be disposed of at the collection points

1. Time and date

11

provided.

Never open the instrument. If these instructions are

2. Systolic pressure

1

not heeded, the warranty will be null and void.

3. Diastolic pressure

10

2

9

Never attempt to repair the instrument or adjust it

4. mmHg unit

yourself. We can no longer guarantee perfect function-

5. Measured pulse

8

3

ing if you do.

6. Pulse icon

4

Repairs may only be performed by Customer Service

7. Number of memory space

5

or authorized dealers. However, always check the

8. Inflate/deflate arrow

76

batteries and replace them if necessary prior to mak-

9. “Change battery” icon

ing any complaint.

10. Cardiac arrhythmia icon

The appliance should be disposed of accor ding

11. WHO classification

to Regulation 2002/96/EC-WEEE (Waste Electri-

cal and Electronic Equipment). In case of que-

ries, please contact the municipal authorities

responsible for waste disposal in your area.

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4. Prepare measurement

Note: If you hold down M, you can set the values faster.

Inserting battery

Press and M simultaneously. The month starts

flashing. Using the M button, set the month 1 to 12

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

and confirm with .

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

Set the day, hour and minute and confirm in each case

Make absolutely sure that you insert the batteries with

with .

the correct polarity as marked. Do not use recharge-

able batteries.

5. Measuring blood pressure

Replace the battery cover carefully.

Please ensure the device is at room temperature before

If the “change battery” icon

is displayed, measure-

measuring.

ment is no longer possible and you must replace all the

Positioning cuff

batteries.

Used batteries do not belong in the household waste.

You are legally obliged to dispose of the batteries. Dis-

pose of them via your specialist electrical supplier or

local collec ting point for recyclable waste.

Note: You will find these markings on bat-

teries containing harmful substances:

Pb = battery containing lead, Cd = bat-

Bare your left wrist, making sure that the circulation in

tery containing cadmium, Hg = battery

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

Pb Cd Hg

containing mercury.

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

Setting date and time

Fasten the cuff with the Velcro fastening so that the

It is vital to set date and time. Only in this way is it pos-

upper edge of the monitor is positioned approx. 1 cm

sible to save and subsequently retrieve your measured

below the ball of your thumb.

values with the right date and time.

The cuff has to be fitted tightly around the wristbut

Time is shown in 24 hour format.

should not constrict it.

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Important: The instrument should only be operated with

and cuff pressure increased further. As soon as a heart

the original cuff.

rate is detected, the heart rate symbol is displayed.

Heart rate, systolic and diastolic blood pressure are dis-

Correct posture

played.

Rest for approx. 5 minutes before each measurement.

You can interrupt measurement at any time by pressing

Otherwise there may be divergences.

the button.

You can perform the measurement

_ appears if it has not been possible to perform the

while sitting or lying. To carry out a

measurement properly. Observe the section in these

blood pressure measurement, make

instructions on error messages/troubleshooting and

• • • • • • • • • • • • •

sure you are sitting comfortably with

repeat the measurement.

your arms and back leaning on

The test result is saved automatically.

something. Do not cross your legs.

Place your feet flat on the ground. Make sure to rest

Evaluating results

your arm and move it. Always make sure that the cuff

Cardiac arrhythmia:

is at heart level. Otherwise significant deviations can

This instrument can identify possible cardiac arrhythmia

occur. Relax your arm and the palm of your hand.

disorders during measurement and if necessary indicates

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

the measurement with the flashing icon .

still during the measurement and not talk.

This may be an indicator for arrhythmia. Arrhythmia

is a condition where the heart rhythm is abnormal as

Measuring blood pressure

a result of defects in the bioelectrical system control-

Switch on the blood pressure monitor with the but-

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

ton.

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

Before the measurement, the last saved test result is

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

briefly displayed. If there is no measurement in the

physical predisposition, excessive use of stimulants,

memory, the instrument always displays the value

.

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

The cuff automatically inflates. Cuff air pressure is

tained through examination by your doctor.

released slowly. If a tendency towards high blood pres-

sure is already detectable, the cuff is pumped up again

18

Repeat the measurement if the flashing icon is

measurements can be classified and assessed accord-

displayed after the measurement. Please note that you

ing to the following table.

should rest for 5 minutes between measurements and not

However, these standard values serve only as a general

talk or move during the measurement. If the icon

guideline, as the individual blood pressure varies in dif-

appears often, please contact your doctor. Any self-diag-

ferent people and different age groups etc.

nosis and treatment based on the test results may be

It is important to consult your doctor regularly for advice.

dangerous. It is vital to follow your doctors instructions.

Your doctor will tell you your individual values for normal

blood pressure as well as the value above which your

WHO classification:

blood pressure is classified as dangerous.

In accordance with the guidelines/definitions of the

World Health Organization and the latest findings, the

Range of blood pressure values Systolic (in mmHg) Diastolic (in mmHg) Measure

Grade 3: Severe hypertension >=180 >=110 Seek medical advice

Grade 2: Moderate hypertension 160 -179 100 -109 Seek medical advice

Grade 1: Mild hypertension 140 -159 90 - 99 Have it checked regularly by doctor

High-normal 130 -139 85 - 89 Have it checked regularly by doctor

Normal 120 -129 80 - 84 Check it yourself

Optimal <120 <80 Check it yourself

Source: WHO, 1999

According to WHO Guidelines/Definitions and the latest

recorded. An accoustic evaluation of your measurement

findings, the test results can be classified and evaluated

also follows.

according to the following chart.

If the values for systolic and diastolic pressure are in

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

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

indicate the range of the blood pressure which has been

mal range and diastolic pressure in the normal range)

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the graphic WHO classification on the unit indicates the

the pump pressure is higher than 300 mmHg (

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

appears on the display),

pumping up takes longer than 160 seconds (

6. Saving, retrieving and deleting results

appears on the display),

The results of each successful measurement are

there is a system or device error ( , , or

stored together with date and time. With more than

appears on the display),

60 items of measured data, the earliest items of data

the batteries are almost empty .

measured are lost.

In the above cases, you must repeat the measurement.

In order to retrieve measurement results again, press

Reinsert the batteries if necessary, or else replace them.

the memory button

M

. The instrument first displays the

number of memory spaces occupied and then automati-

Technical alarm – description

cally switches to the last saved test result.

Should the recorded blood pressure (systolic or dias-

If you continue pressing the memory button M, the last

tolic) lie outside the limits specified in the section “Tech-

results in each case are measured are displayed with

nical specifications”, the technical alarm will appear on

date, time and graphic WHO classification.

the display indicating either

or . In such cases, you

You can clear the memory by holding down the mem-

should seek medical assistance and check the accuracy

ory button M for 3 seconds.

of your procedure.

The limit values for the technical alarm are factory set

7. Error messages/troubleshooting

and cannot be adjusted or deactivated. These alarm limit

In case of faults, the

_

message appears in the display.

values are accorded second priority under the standard

Error messages may appear if:

IEC 60601-1-8.

systolic or diastolic pressure could not be measured

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

( or appears on the display),

be reset. The signal shown on the display will disappear

systolic or diastolic pressure was outside the measure-

automatically after about 8 seconds.

ment range (

or appears on the display),

the cuff is fastened too tightly or loosely ( or

appears on the display),

20

8. Cleaning and Care

Weight Approx. 112 g (without batteries)

Clean your blood pressure monitor carefully using a

Cuff size 140 to 195 mm

slightly damp cloth only.

Permissible oper-

+5 °C to +40 °C, ≤ 90 % relative air

Do not use any detergents or solvents.

ating conditions

humidity (non-condensing)

Never hold the instrument under water as otherwise

liquid can penetrate and damage the instrument.

Permissible

-20 °C to +55 °C, ≤ 95 % relative air

Never place any heavy objects on the instrument.

storage conditions

humidity, 800 –1050 hPa ambient

pressure

9. Technical details

Power supply

2 x 1,5 V

AAA batteries

Model no. BC 31

Battery life For approx. 180 measurements,

Measurement

Oscillometric, non-invasive blood

depending on the blood pressure

method

pressure measurement on the wrist

level and/or pump pressure

Measurement

Cuff pressure 0 – 300 mmHg,

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

range

systolic 60 – 260 mmHg,

teries, storage box

diastolic 40 –199 mmHg,

Classification Internal supply, IPX0, no AP or

Pulse 40 –180 beats/minute

APG, continuous operation, type BF

Display accuracy systolic ± 3 mmHg,

applied part

diastolic ± 3 mmHg,

Technical information is subject to change without notifi-

pulse ± 5 % of the value shown

cation to allow for updates.

Measurement

Max. permissible standard deviation

This unit is in line with European Standard

inaccuracy

according to clinical testing:

EN 60601-1-2 and is subject to particular precautions

systolic 8 mmHg /diastolic 8 mmHg

with regard to electromagnetic compatibility (EMC).

Memory 60 memory spaces

Please note that portable and mobile HF communica-

Dimensions L 84 mm x W 62 mm x H 30 mm

tion systems may interfere with this unit. More details

21

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.

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