Beurer BC 16: ENGLISH

ENGLISH: Beurer BC 16

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. You can use it to measure your blood pressure quickly

Type BF applied part

and easily, storing the results and displaying the progres-

sion of readings together with the average.

A warning is issued for anyone suffering from cardiac

Direct current

arrhythmia.

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

Keep these instructions carefully for further use and also let

Electronic Equipment).

other users have access to them.

13

Do not take a measurement within 30 minutes after eat-

Manufacturer

ing, drinking, smoking or exercising.

Repeat the measurement if you are unsure of the meas-

60°C

Temperature limitation

ured value.

-10°C

The measurements taken by you are for your information

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

Permissible storage humidity

Discuss the measurements with your doctor, and never

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

RH 10-90%

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 vascu-

SN Serial number

lar constriction), the accuracy of the wrist measurement is

The CE labelling certifies that the prod-

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

uct complies with the essential require-

blood pressure monitor.

0483

ments of Directive 93/42/EEC on medical

Cardiovascular diseases may lead to incorrect measure-

products.

ments or have a detrimental effect on measurement accu-

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

Advice on use

diabetes, circulatory disorders and arrhythmias as well as

chills or shaking.

In order to ensure comparable values, always measure

The blood pressure monitor must not be used in connec-

your blood pressure at the same time of day.

tion with a high-frequency surgical unit.

Before every measurement, relax for about five minutes.

Only use the unit on people who have the specified wrist

If you want to perform several measurements on the same

measurement for the device.

person, wait five minutes between each measurement.

Please note that when inflating, the functions of the limb

in question may be impaired.

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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

Only ever use the cuffs provided with the monitor or

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

original replacement cuffs. Otherwise erroneous results

intravascular access or therapy, or an arteriovenous (AV)

will be recorded.

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 fur-

Advice on batteries

ther injury.

The blood pressure monitor can only be operated with

Batteries can be fatal if swallowed. You should therefore

batteries.

store the batteries and products where they are inaccessi-

To conserve the batteries, the monitor switches off auto-

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

matically if no buttons are pressed for one minute.

a doctor immediately.

The device is only intended for the purpose described in

Batteries should not be charged or reactivated with any

these instructions for use. The manufacturer is not liable

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

for damage resulting from improper or careless use.

the fire or short-circuited.

Remove the batteries from the instrument if they are worn

Storage and Care

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

The blood pressure monitor is made up of precision elec-

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

tronic components. Accuracy of readings and the instru-

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

ment’s service life depend on careful handling.

15

Never use different types of battery, battery brands or

3. Unit description

batteries with different capacities. You should preferably

1. LCD Display

use alkaline batteries.

1

2. Battery Cover

2

3. Date/Time Set Key

Repair and disposal

4

4. Memory Recall Key M

Batteries do not belong in domestic refuse. Used batteries

5. ON/OFF Key

7

should be disposed of at the collection points provided.

6. User-Switching Key

Never open the instrument. If these instructions are not

6

7. Wrist Cuff

heeded, the warranty will be null and void.

3

Never attempt to repair the instrument or adjust it your-

5

self. We can no longer guarantee perfect functioning if

you do.

Icons in the display:

Repairs may only be performed by Beurer Customer Ser-

vice or authorized dealers. However, always check the

1. Date/Time Indicator

1

batteries and replace them if necessary prior to making

2. WHO classification

3. Memory Zones

2

any complaint.

10

The appliance should be disposed of according to

4. Weak Battery Mark

5. Memory Sequence Number

3

Regulation 2002/96/EC-WEEE (Waste Electrical

9

6. Cardiac arrhythmia icon

4

and Electronic Equipment). In case of queries,

please contact the municipal authorities responsible for

7. Pulse Mark

waste disposal in your area.

8. Pulse Rate

5

8

9. Diastolic Pressure

6

7

10. Systolic Pressure

11. Problem shown on the display

11

16

4. Prepare measurement

Press the key and to adjust the month. Then press the

and in turn to adjust the date, hour, minute and con-

Inserting battery

firm the entry .

Remove the battery compartment cover.

The time is being displayed in 12-hour format, which means

Insert the two batteries into the battery compartment

a time from 13:00 onwards is being displayed as pm 1:00.

ensuring correct polarity.

Use exclusively brand-name batteries of the type 2 x 1.5 V

5. Measuring blood pressure

Micro (Alkaline Type LR03).

Positioning cuff

Then close the battery compartment by fitting the cover

and clicking it in position.

If the battery change is continuously illuminated, meas-

urement is no longer possible and you must replace all the bat-

teries. Once batteries have been removed from the device, the

time must be reset. The stored measured values are last.

Used batteries do not belong in the household waste. You are

legally obliged to dispose of the batteries. Dispose of them

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

via your specialist electrical supplier or local collec ting point

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

for recyclable waste.

Position the cuff on the inside of your wrist.

Note:

Batteries containing pollutant substances

Fasten the cuff with the Velcro fastening so that the upper

are marked as follows: Pb = Battery contains

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

lead, Cd = Battery contains cadmium,

ball of your thumb.

Hg = Battery contains mercury.

The cuff has to be fitted tightly around the wristbut should

not constrict it.

Setting date and time

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

Important: The instrument should only be operated with the

ble to save and subsequently retrieve your measured values

original cuff.

with the right date and time.

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Correct posture

Measuring blood pressure

Rest for approx. 5 minutes before each measurement.

Put on the cuff as described previously and assume the

Otherwise there may be divergences.

position in which you want to carry out the measurement.

You can perform the measurement while

Press the User-Switching key

to select a memory

sitting or lying. To carry out a blood

zone, and press the key 2x to start measurement in

pressure measurement, make sure you

the chosen memory zone. After checking the display with

are sitting comfortably with your arms

all digits lighting up, the monitor will automatically inflate.

and back leaning on something. Do not

Following the self-test, during which all display elements

cross your legs. Place your feet flat on

briefly appear, the measurement begins. During inflation

the ground. Make sure to rest your arm

the device already determines measured values used to

and move it. Always make sure that the cuff is at heart

estimate the required inflation pressure. If this pressure is

level. Otherwise significant deviations can occur. Relax

insufficient, the device automatically inflates by another

your arm and the palm of your hand.

40 mmHg (Real Fuzzy Logic).

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

Then the pressure in the cuff is slowly released and the

during the measurement and not talk.

pulse is measured.

When the measurement has been completed, the remain-

Select memory

ing air pressure is released very quickly. The pulse, the

You have two memories (50 memory spaces each) in order to

systolic and the diastolic blood pressure are displayed.

save the test results of 2 different people separately, or else

The device requires approx. 5 seconds to store the deter-

save measurements in the morning and evening separately.

mined measured value.

Select the required memory space by pressing the user

You can interrupt measurement at any time by pressing

selection button

.

the ON/OFF button .

To switch off and release the pressure, press the ON/OFF

button again. If you forget to switch off the device, it

switches off automatically after approx. 1 minute.

Wait at least 5 minutes before taking another measurement!

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• • • • • • • • • • • •

Evaluating results

move during the measurement. If the icon appears often,

Cardiac arrhythmia:

please contact your doctor. Any self-diagnosis and treat-

ment based on the test results may be dangerous. It is vital

This instrument can identify possible cardiac arrhythmia dis-

to follow your doctor’s instructions.

orders during measurement and if necessary indicates the

measurement with the flashing icon

.

WHO classification:

This may be an indicator for arrhythmia. Arrhythmia is a

The World Health Organization (WHO) and National High

condition where the heart rhythm is abnormal as a result of

Blood Pressure Education Program Coordinating Commit-

defects in the bioelectrical system controlling the heart beat.

tee have developed a blood pressure standard, according to

The symptoms (omitted or premature heart beats, slow or

which areas of low- and high-risk blood pressure are identi-

excessively fast heart rate) may be caused, among other

fied. This standard, however, is a general guideline as indi-

things, by heart disease, age, physical predisposition, exces-

vidual’s blood pressure varies among different people and

sive use of stimulants, stress or lack of sleep. Arrhythmia can

different age groups ... etc.

only be ascertained through examination by your doctor.

It is important that you consult with your physician regu-

Repeat the measurement if the flashing icon is dis-

larly. Your physician will tell you your normal blood pres-

played after the measurement. Please note that you should

sure range as well as the point at which you will be consid-

rest for 5 minutes between measurements and not talk or

ered at risk.

Table for classification of blood pressure values (unit of measurement mmHg) for adults:

Range Systolic Diastolic Action

Hypotonia (degraded blood pressure) lower than 105 lower than 60 Check with doctor

Normal range between 105 and 120 between 60 and 80 Self check

Pre-hypertensive blood pressure range (*)

between 120 and 140 between 80 and 90 Check with doctor

High blood pressure - degree

between 140 and 160 between 90 and 100 Consult your doctor

High blood pressure - degree

higher than 160 higher than 100

Consult your doctor

(*) Blood pressure range that might transfer to high blood pressure Adapted from JNC 2003

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The WHO classification in the display shows the range of

7. Cleaning and storing the instrument

the measured blood pressure.

Clean your blood pressure monitor carefully using a

If the values for systolic and diastolic pressure are in two dif-

slightly damp cloth only.

ferent WHO ranges (e.g. systolic in the grade

hyperten-

Do not use any detergents or solvents.

sion range and diastolic pressure in the normal range), the

Never hold the instrument under water as otherwise liquid

WHO classification on the unit always indicates the higher

can penetrate and damage the instrument.

range (grade hypertension in the example described).

Never place any heavy objects on the instrument.

6. Saving, retrieving and deleting results

8. Rectifying faults

The computer automatically saves the blood pressure read-

Error messages can occur when

ings of the last 50 measurements. When the 50 memory

the blood-pressure value is unusually high or low (

locations are exceeded, the current oldest value is deleted.

appears in the display),

You can display the memory as follows:

you move or talk during the measurement ( appears in

Press the User-Switching key

to select a mem-

the display),

ory zone, and press the M key to switch from memory to

the cuff tube is not properly inserted ( appears in the

memory with sequence numbers.

display),

The saved measured values are continuously stored.

inflation takes longer than 20 seconds ( appears in the

Press the On/Off switch to turn the unit off.

display),

If you forget to switch off the computer, it will switch off

the inflation pressure is higher than 300 mmHg (

automatically after 1 minute.

appears in the display),

Press the User-Switching key

to select a memory

an error occurs when storing the measured values (

zone, then press and hold the M key for approximately

appears in the display),

5-seconds to clear the data in the pre-designated memory

Exceeding measurement range ( appears in the display).

zone. The data in both memory zones – zone 1 and zone 2

In the about cases, you must repeat the measurement. Put

may be erased if any of the batteries is removed.

the batteries back in if necessary, or else replace them.

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9. Specifications

Power supply

2 x 1,5 V

AA batteries

Model no. BC 16

Battery life For approx. 300 measurements,

Measurement

Oscillometric, non-invasive blood

depending on the blood pressure

method

pressure measurement on the wrist

level and/or pump pressure

Measurement range Cuff pressure 0 299 mmHg,

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

systolic 30 – 260 mmHg,

teries, storage box

diastolic 30 – 260 mmHg,

Classification Internal supply, IPX0, no AP or

Pulse 40 – 199 beats/minute

APG, continuous operation, type BF

Display accuracy Systolic ± 3 mmHg,

applied part

diastolic ± 3 mmHg,

Technical information is subject to change without notifica-

pulse ± 5 % of the value shown

tion to allow for updates.

Measurement

Max. permissible standard deviation

inaccuracy

according to clinical testing:

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

systolic 8 mmHg /diastolic 8 mmHg

and is subject to particular precautions with regard to

electromagnetic compatibility (EMC). Please note that

Memory 2 x 50 memory spaces

portable and mobile HF communication systems may

Dimensions L 82 mm x W 69 mm x H 28 mm

interfere with this unit. More details can be requested from

Weight Approx. 120 g (without batteries)

the stated Customer Service address or found at the end

Cuff size 135 to 220 mm

of the instructions for use.

This device is in line with the EU Medical Devices Direc-

Permissible operating

+10 °C to +40 °C, 40 – 85 % relative

tive 93/42/EC, the “Medizinproduktegesetz” (German

conditions

air humidity (non-condensing)

Medical Devices Act) and the standards EN1060-1

Permissible storage

-10 °C to +60 °C, 10 – 90 % relative

(non-invasive sphygmomanometers, Part 1: General

conditions

air humidity, 800-1050 hPa ambient

requirements), EN1060-3 (non-invasive sphygmoma-

pressure

nometers, Part 3: Supplementary requirements for elec-

21

tro-mechanical blood pressure measuring 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 pur-

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

priate means. Precise instructions for checking accuracy

may be requested from the service address.

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