Beurer BC 44: ENGLISH

ENGLISH: Beurer BC 44

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 pressure,

The following symbols are used in these instructions for

body temperature, pulse, gentle therapy, massage and air.

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

Please read these instructions for use carefully and keep

and accessories:

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

Caution

users and observe the information they contain.

Best regards,

Your Beurer Team

Note

Note on important information

1. Getting to know your instrument

The wrist blood pressure monitor is used for non-invasive

Follow instructions for use

measurement and monitoring of adults’ arterial blood pres-

sure.

This allows you to quickly and easily measure your blood

Type BF applied part

pressure and to display the last recorded measurement.

A warning is issued for anyone suffering from cardiac ar-

rhythmia.

Direct current

The values determined are classified and graphically evalu-

Disposal in accordance with EC Directive

ated according to WHO guidelines.

2002/96/EC – WEEE (Waste Electrical and

Electronic Equipment).

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Manufacturer

13

Storage

Permissible storage temperature and hu-

55°C

midity

-20°C

RH ≤90%

Operating

Repeat the measurement if you are unsure of the meas-

ured value.

The measurements taken by you are for your information

only – they are not a substitute for a medical examination!

Discuss the measurements with your doctor, and never

base any medical decisions on them (e.g. medicines and

Permissible operating temperature and

40°C

their administration)!

humidity

10°C

Do not use the blood pressure monitor on newborns,

RH ≤90%

pregnant women or patients with preeclampsia.

Keep dry

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

SN Serial number

limited. In this case you should avoid using an upper arm

The CE labelling certifies that the product

blood pressure monitor.

complies with the essential requirements

Cardiovascular diseases may lead to incorrect measure-

of Directive 93/42/EEC on medical prod-

ments or have a detrimental effect on measurement ac-

0483

ucts.

curacy. The same also applies to very low blood pressure,

diabetes, circulatory disorders and arrhythmias as well as

chills or shaking.

Advice on use

The blood pressure monitor must not be used in connec-

In order to ensure comparable values, always measure

tion with a high-frequency surgical unit.

your blood pressure at the same time of day.

Only use the unit on people who have the specified wrist

Before every measurement, relax for about five minutes.

measurement for the device.

If you want to perform several measurements on the same

Please note that when inflating, the functions of the limb

person, wait five minutes between each measurement.

in question may be impaired.

Do not take a measurement within 30 minutes after eat-

ing, drinking, smoking or exercising.

During the blood pressure measurement, blood circulation

You should protect the device from impact, moisture,

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

dirt, major temperature fluctuations and direct exposure

device malfunctions, remove the cuff from the arm.

to the sun’s rays.

Do not allow sustained pressure in the cuff or frequent

Never drop the device.

measurements. The resulting restriction of the blood flow

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

may cause injury.

it away from any radio systems and mobile phones.

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

Do not press the start/stop button

before the cuff is

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

placed on.

intravascular access or therapy, or an arteriovenous (AV)

We advise you to remove the batteries if the device is not

shunt.

going to be used for a longer period of time.

Do not use the cuff on people who have undergone a

Advice on batteries

mastectomy.

Do not place the cuff over wounds as this may cause fur-

Batteries can be fatal if swallowed. You should therefore

ther injury.

store the batteries and products where they are inaccessi-

The blood pressure monitor can only be operated with

ble to small children. If a battery has been swallowed, call

batteries.

a doctor immediately.

To conserve the batteries, the monitor switches off auto-

Batteries should not be charged or reactivated with any

matically if no buttons are pressed for one minute.

other means, nor should they be taken apart, thrown in

The device is only intended for the purpose described in

the fire or short-circuited.

these instructions for use. The manufacturer is not liable

Remove the batteries from the instrument if they are worn

for damage resulting from improper or careless use.

out or if you are not going to use the instrument for any

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

Storage and Care

leakage. Always replace all the batteries at the same time.

The blood pressure monitor is made up of precision elec-

Never use different types of battery, battery brands or

tronic components. Accuracy of readings and the instru-

batteries with different capacities. You should preferably

ment’s service life depend on careful handling.

use alkaline batteries.

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Repair and disposal

3. Unit description / Icons in the display

Batteries do not belong in domestic refuse. Used batter-

1

ies should be disposed of at the collection points pro-

WHO

vided.

10

SYS

Never open the instrument. If these instructions are not

mmHg

9

2

heeded, the warranty will be null and void.

Never attempt to repair the instrument or adjust it your-

DIA

self. We can no longer guarantee perfect functioning if

8

mmHg

you do.

PUL

/min

Repairs may only be performed by Customer Service or

authorized dealers. However, always check the batteries

7

3

and replace them if necessary prior to making any

6

complaint.

4

The appliance should be disposed of according

5

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

1. Systolic pressure

cal and Electronic Equipment). In case of queries,

2. Diastolic pressure

please contact the municipal authorities responsible for

3. Pulse

waste disposal in your area.

4. Pulse symbol

5. Battery compartment

6. Start/stop button

7. Battery replacement symbol

8. Deflate arrow

9. Arrhythmia recognition

10. WHO indicator

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4. Prepare measurement

Positioning cuff

Inserting battery

Bare your left wrist, making sure that the circulation in the

arm is not restricted by any clothes etc. that are too tight.

Remove the battery compartment lid on

Position the cuff on the inside of your wrist.

the lower left side of the device.

Fasten the cuff with the Velcro fastening so that the upper

Insert two 1.5 V micro batteries (alka-

edge of the monitor is positioned approx. 1 cm below the

line, type LR03).

ball of your thumb.

Make sure that the batteries are insert-

The cuff has to be fitted tightly around the wristbut should

ed with the correct polarity, according

not constrict it.

to the label on the battery compartment

lid. Do not use rechargeable batteries.

1

2 3

Replace the battery cover carefully.

1 cm

If the battery change

is continuously illuminated, meas-

W

HO

urement is no longer possible and you must replace all the

SYS

mm

PUL

/min

DIA

Hg

mm

Hg

batteries.

Used batteries do not belong in the household waste. You

are legally obliged to dispose of the batteries. Dispose of

them via your specialist electrical supplier or local collec ting

Important: The instrument should only be operated with the

point for recyclable waste.

original cuff.

Note: Batteries containing pollutant substances

Correct posture

are marked as follows: Pb = Battery contains

Rest for approx. 5 minutes before each measurement.

lead, Cd = Battery contains cadmium,

Otherwise there may be divergences.

Hg = Battery contains mercury.

You can perform the measurement ei-

5. Measuring blood pressure

ther sitting or lying down. To carry out

Please ensure the device is at room temperature before

a blood pressure measurement, make

measuring.

sure you are sitting comfortably with

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• • • •

your arms and back leaning on something. Do not cross

_ appears if it has not been possible to perform the

your legs. Place your feet flat on the ground. It is essen-

measurement properly. Observe the section in these in-

tial to support your arm and have it at an angle. Always

structions on error messages/troubleshooting and repeat

make sure that the cuff is level with your heart. Otherwise

the measurement.

there may be serious divergences. Relax your arm and the

The test result is saved automatically.

palms of your hands.

Evaluating results

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

Cardiac arrhythmia:

during the measurement and not talk.

This instrument can identify possible cardiac arrhythmia dis-

Measuring blood pressure

orders during measurement and if necessary indicates the

Start the blood pressure monitor with the start/stop but-

measurement with the flashing icon

.

ton

. A beep and a brief display of all the symbols con-

This may be an indicator for arrhythmia. Arrhythmia is a

firm that the device is switched on.

condition where the heart rhythm is abnormal as a result

Before the measurement, the last saved test result is

of defects in the bioelectrical system controlling the heart

briefly displayed. If there is no measurement in the memo-

beat. The symptoms (omitted or premature heart beats,

ry, the instrument always displays the value

.

slow or excessively fast heart rate) may be caused, among

The cuff automatically inflates. Cuff air pressure is re-

other things, by heart disease, age, physical predisposi-

leased slowly.

tion, excessive use of stimulants, stress or lack of sleep.

If a tendency towards high blood pressure is already de-

Arrhythmia can only be ascertained through examination by

tectable, the cuff is pumped up again and cuff pressure

your doctor.

increased further. The pulse symbol flashes

as soon

Repeat the measurement if the flashing icon

is dis-

as a pulse is found.

played after the measurement. Please note that you should

After the pressure has been completely reduced, the sys-

rest for 5 minutes between measurements and not talk or

tolic pressure, diastolic pressure and pulse readings are

move during the measurement. If the icon

appears

displayed.

often, please contact your doctor. Any self-diagnosis and

Measuring can be cancelled at any time by pressing the

treatment based on the test results may be dangerous. It is

start/stop button

.

vital to follow your doctor’s instructions.

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WHO classification:

Optimal < 120 < 80 Check it yourself

In accordance with the guidelines/definitions of the World

Source: WHO, 1999

Heath Organization and the latest findings, the measure-

ments can be classified and assessed according to the fol-

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

lowing table.

dicate the range of the blood pressure which has been

However, these standard values serve only as a general

recorded.

guideline, as the individual blood pressure varies in different

If the values for systolic and diastolic pressure are in two

people and different age groups etc.

different WHO ranges (e.g. systolic in the high-normal range

It is important to consult your doctor regularly for advice.

and diastolic pressure in the normal range) the graphic WHO

Your doctor will tell you your individual values for normal

classification on the unit indicates the higher range (high-

blood pressure as well as the value above which your blood

normal in the example described).

pressure is classified as dangerous.

6. Error messages/troubleshooting

Range of blood

Systolic

Diastolic

Measure

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

pressure values

(in mmHg)

(in mmHg)

Error messages may appear if:

Grade 3:

>= 180 >= 110 Seek medical

systolic or diastolic pressure could not be measured (

Severe hyper-

advice

or

appears on the display)

tension

systolic or diastolic pressure was outside the measure-

Grade 2:

160 – 179 100 – 109 Seek medical

ment range (Hi or Lo appears on the display)

Moderate

advice

the cuff is fastened too tightly or loosely (

or ap-

hyper tension

pears on the display)

the pump pressure is higher than 300 mmHg (

appears

Grade 1: Mild

140 – 159 90 – 99

Have it checked

on the display)

hypertension

regularly by doctor

pumping up takes longer than 160 seconds (

appears

High normal 130 – 139 85 – 89

Have it checked

on the display)

regularly by doctor

there is a system or device error (

, , or

Normal 120 – 129 80 – 84 Check it yourself

appears on the display)

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the batteries are almost empty .

8. Technical details

In such cases, repeat the measurement. Ensure you do not

Model no. BC 44

move or speak.

Measurement

Oscillometric, non-invasive blood pres-

If necessary, re-insert or replace the batteries.

method

sure measurement on the wrist

Technical alarm – description

Measurement

Cuff pressure 0 300 mmHg,

range

systolic 60 – 260 mmHg,

Should the recorded blood pressure (systolic or diastolic)

diastolic 40 –199 mmHg,

lie outside the limits specified in the section “Technical

specifications”, the technical alarm will appear on the dis-

Pulse 40 –180 beats/minute

play indicating either “Hi” or “Lo. In such cases, you should

Display accuracy Systolic ± 3 mmHg, diastolic ± 3 mmHg,

seek medical assistance and check the accuracy of your

pulse ± 5 % of the value shown

procedure.

Measurement

Max. permissible standard deviation

The limit values for the technical alarm are factory set and

inaccuracy

according to clinical testing:

cannot be adjusted or deactivated. These alarm limit val-

systolic 8 mmHg /diastolic 8 mmHg

ues are accorded second priority under the standard IEC

Dimensions L 87,8 mm x W 65,8 mm x H 28,6 mm

60601-1-8.

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

Weight Approx. 98 g (without batteries)

reset. The signal shown on the display will disappear auto-

Cuff size 140 to 195 mm

matically after about 8 seconds.

Permissible oper-

+ 10 °C to + 40 °C, ≤ 90 % relative air

7. Cleaning and care

ating conditions

humidity (non-condensing)

Clean your blood pressure monitor carefully using a

Permissible stor-

- 20 °C to + 55 °C, ≤ 90 % relative air hu-

slightly damp cloth only.

age conditions

midity, 800 –1050 hPa ambient pressure

Do not use any detergents or solvents.

Power supply

2 x 1,5 V

AAA batteries

Never hold the instrument under water as otherwise liquid

can penetrate and damage the instrument.

Never place any heavy objects on the instrument.

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Part 2 30: Particular requirements for the safety and

Battery life For approx. 180 measurements, depend-

essential performance of automated non-invasive blood

ing on the blood pressure level and/or

pressure monitors).

pump pressure

The accuracy of this blood pressure monitor has been

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

carefully checked and developed with regard to a long

ies, storage box

useful life. If using the device for commercial medical pur-

Classification Internal supply, IPX0, no AP or APG,

poses, it must be regularly tested for accuracy by appro-

continuous operation, type BF applied

priate means. Precise instructions for checking accuracy

part

may be requested from the service address.

Technical information is subject to change without notifica-

tion to allow for updates.

This unit 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 in-

terfere 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 Direc-

tive 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 sphygmoma-

nometers, Part 3: Supplementary requirements for

electro-mechanical blood pressure measuring systems)

and IEC 80601-2-30 (Medical electrical equipment –

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