Beurer BC 58: ENGLISH

2. Important information

Storage

Permissible transport and storage tempe-

55°C

Signs and symbols

rature. Permissible transport and storage

-20°C

RH ≤95%

humidity.

The following symbols are used in these instructions for

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

and accessories:

Caution

Note

Note on important information

Follow instructions for use

Type BF applied part

Direct current

Please dispose of the device in accordance

with EC Directive – WEEE (Waste Electrical

and Electronic Equipment).

Manufacturer

16

Permissible operating temperature and

40°C

humidity.

5°C

RH ≤90%

Keep dry

SN Serial number

The CE labelling certifies that the prod-

uct complies with the essential require-

0483

ments of Directive 93/42/EEC on medical

products.

Advice 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 after eat-

ing, drinking, smoking or exercising.

•

Repeat the measurement if you are unsure of the meas-

ured value.

•

The measurements taken by you are for your information

•

Do not allow sustained pressure in the cuff or frequent

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

measurements. The resulting restriction of the blood flow

Discuss the measurements with your doctor, and never

may cause injury.

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

•

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

their administration)!

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

•

Do not use the blood pressure monitor on newborns,

intravascular access or therapy, or an arteriovenous (AV)

pregnant women or patients with preeclampsia.

shunt.

•

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

•

Do not use the cuff on people who have undergone a

of chronic or acute vascular diseases (including vascu-

mastectomy.

lar constriction), the accuracy of the wrist measurement is

•

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

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

ther injury.

blood pressure monitor.

•

The blood pressure monitor can only be operated with

•

Cardiovascular diseases may lead to incorrect measure-

batteries.

ments or have a detrimental effect on measurement accu-

•

To conserve the batteries, the monitor switches off auto-

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

matically if no buttons are pressed for one minute.

diabetes, circulatory disorders and arrhythmias as well as

•

The device is only intended for the purpose described in

chills or shaking.

these instructions for use. The manufacturer is not liable

•

The blood pressure monitor must not be used in connec-

for damage resulting from improper or careless use.

tion 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 elec-

•

Please note that when inflating, the functions of the limb

tronic components. Accuracy of readings and the instru-

in question may be impaired.

ment’s service life depend on careful handling.

•

During the blood pressure measurement, blood circula-

– You should protect the device from impact, moisture,

tion must not be stopped for an unnecessarily long time.

dirt, major temperature fluctuations and direct exposure

If the device malfunctions, remove the cuff from the arm.

to the sun’s rays.

17

– Never drop the device.

• Use identical or equivalent battery types only .

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

• Always replace all batteries at the same time.

it away from any radio systems and mobile phones.

• Do not use rechargeable batteries.

– Only ever use the cuffs provided with the monitor or

• Do not disassemble, split or crush the batteries.

original replacement cuffs. Otherwise erroneous results

Repair and disposal

will be recorded.

•

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

•

Batteries do not belong in domestic refuse. Used batter-

•

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

ies should be disposed of at the collection points pro-

recommend removing the batteries.

vided.

•

Never open the instrument. If these instructions are not

Notes on handling batteries

heeded, the warranty will be null and void.

•

If your skin or eyes come into contact with battery fluid,

•

Never attempt to repair the instrument or adjust it your-

flush out the affected areas with water and seek medical

self. We can no longer guarantee perfect functioning if

assistance.

you do.

•

Repairs may only be performed by Beurer Customer Ser-

•

Choking hazard! Small children may swallow and

vice or authorized dealers. However, always check the

choke on batteries. Store the batteries out of the reach of

batteries and replace them if necessary prior to making

small children.

any complaint.

• Observe the plus (+) and minus (-) polarity signs.

•

For environmental reasons, do not dispose of the

• If a battery has leaked, put on protective gloves and clean

device in the household waste at the end of its use-

the battery compartment with a dry cloth.

ful life. Dispose of the unit at a suitable local collec-

• Protect the batteries from excessive heat.

tion or recycling point. Dispose of the device in accord-

•

Risk of explosion! Never throw batteries into a fire.

ance with EC Directive – WEEE (Waste Electrical and

• Do not charge or short-circuit batteries.

Electronic Equipment). If you have any questions, please

• If the device is not to be used for a long period, take the

contact the local authorities responsible for waste dis-

batteries out of the battery compartment.

posal.

18

3. Unit description

Icons in the display:

1

9

1. Time and date

8

2

1. Display

2. WHO classification

8

3. Systolic pressure

3

2. Memory button MEM

7

3. START/STOP button

4. Diastolic pressure

6

4

4. USB interface

5. Measured pulse

5

min

5. Touch screen activation

6. „Change battery“ icon

switch

7. Pump up, release air (arrow)

6. Battery cover

8. Memory display

( )

, average value ( ), morning ( ),

evening ( )

9. Cardiac arrhythmia icon

PC interface

The Beurer blood pressure monitor also allows you to trans-

Touch screen activation switch

fer your measured values to the PC.

To do this you require a USB cable (included in delivery) and

The device features a touch screen display. To prevent the

the Beurer “Health Manager” PC software.

screen from being activated accidentally, keep the touch

The software can be downloaded free of charge from

screen activation switch set to OFF when the device is not

www.beurer.com/service/download

in use. To operate the device, move the touch screen acti-

vation switch to ON. When the touch screen display is

System requirements for the Beurer “Health Manager”

touched (START/STOP button

or MEM button), a beep

computer software

is output.

1. Supported operating systems:

Tip: You can switch off the device at any time by setting the

•

Windows XP SP3

touch screen activation switch to the OFF position.

•

Windows Vista SP1 or later

•

Windows 7

•

Windows 7 SP1

19

2. Supported architectures:

The empty, completely flat batteries must be disposed of

•

x86 (32 bit)

through specially designated collection boxes, recycling

•

x64 (64 bit)

points or electronics retailers. You are legally required to dis

-

pose of the batteries.

3. Hardware requirements:

The codes below are printed on batteries

•

Recommended: at least Pentium 1 GHz or faster with at

containing harmful substances:

least 1 GB RAM

Pb = Battery contains lead,

•

Free memory on the primary partition of at least:

Cd = Battery contains cadmium,

– x86 – 600 MB

Hg = Battery contains mercury.

– x64 – 1.5 GB

•

Graphic resolution from: 1024 x 768 pixels

Setting date and time

•

USB port 1.0 or later

You should set the date and time without fail. Otherwise,

you will not be able to save your measured values correctly

4. Prepare measurement

with a date and time and to access them again later.

Inserting battery

Tip: If you press and hold the MEM button, you can set the

•

Open the battery compartment lid.

values more quickly.

• Use exclusively brand-name batter-

To set the date and time, proceed as follows:

ies of the type: 2 x 1.5 V Micro (Alkaline

•

Move the touch screen activation switch to the ON position.

Type LR 03). Making absolutely sure

•

Press the START/STOP and MEM buttons simultane-

that you insert them with the correct

ously, 24h begins to flash. Select 12h or 24h mode using

polarity as marked. Do not use rechargeable batteries.

the MEM button. Press START/STOP to confirm your

• Replace the battery cover carefully.

selection. The year display will start to flash. Set the year

If the battery change is continuously illuminated, meas-

with the MEM button and confirm with START/STOP .

urement is no longer possible and you must replace all

•

Then set the month, day, hour and minutes and confirm

the batteries. Once batteries have been removed from the

each setting with START/STOP .

device, the time must be reset.

20

•

Pressing the START/STOP button again will switch the

Correct posture

display off.

•

Rest for approx. 5 minutes before each measurement.

Otherwise there may be divergences.

5. Measuring blood pressure

•

You can perform the measurement

Please ensure the device is at room temperature before

while sitting or lying. To carry out a

measuring.

blood pressure measurement, make

Positioning cuff

sure you are sitting comfortably with

your arms and back leaning on some-

thing. 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.

•

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

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

Measuring blood pressure

Position the cuff on the inside of your wrist.

•

Move the touch screen activation switch to the ON posi-

•

Fasten the cuff with the Velcro fastening so that the upper

tion.

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

•

Switch on the blood pressure monitor with the START/

ball of your thumb.

STOP button . After the full-screen display, the most

•

The cuff has to be fitted tightly around the wristbut should

recently used user memory appears ( or ). To change

not constrict it.

the user memory, press the MEM button and confirm

Important: The instrument should only be operated with the

your selection with the START/STOP button . If no but-

original cuff.

ton is pressed, the most recently used user memory is

automatically used after 5 seconds.

21

•

Before the measurement, the last saved test result is

6. Evaluating results

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

Cardiac arrhythmia:

ory, the instrument always displays the value

.

This instrument can identify possible cardiac arrhythmia dis-

•

The cuff automatically inflates. Cuff air pressure is

orders during measurement and if necessary indicates the

released slowly. If a tendency towards high blood pres-

measurement with the flashing icon

.

sure is already detectable, the cuff is pumped up again

This may be an indicator for arrhythmia. Arrhythmia is a

and cuff pressure increased further. As soon as a heart

condition where the heart rhythm is abnormal as a result

rate is detected, the heart rate symbol

is displayed.

of defects in the bioelectrical system controlling the heart

•

After the pressure has been completely reduced, the sys-

beat. The symptoms (omitted or premature heart beats,

tolic pressure, diastolic pressure and pulse readings are

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

displayed.

other things, by heart disease, age, physical predisposition,

•

You can cancel the measurement at any time by press-

excessive use of stimulants, stress or lack of sleep. Arrhyth-

ing the START/STOP button

or by pushing the touch

mia can only be ascertained through examination by your

screen activation button to OFF.

doctor.

•

appears if it has not been possible to perform the

Repeat the measurement if the flashing icon is dis-

measurement properly. Observe the section in these

played after the measurement. Please note that you should

instructions for use on error messages/troubleshooting

rest for 5 minutes between measurements and not talk or

and repeat the measurement.

move during the measurement. If the icon appears

•

The test result is saved automatically.

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

•

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

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

or push the touch screen activation switch to OFF. If

vital to follow your doctor’s instructions.

you forget to switch off the device, it switches off auto-

matically after approx. 1 minute.

WHO classification:

In accordance with the guidelines/definitions of the World

Wait at least 5 minutes before taking another measurement!

Health Organization and the latest findings, the measure-

ments can be classified and assessed according to the fol-

lowing table.

22

However, these standard values serve only as a general

It is important to consult your doctor regularly for advice.

guideline, as the individual blood pressure varies in different

Your doctor will tell you your individual values for normal

people and different age groups etc.

blood pressure as well as the value above which your blood

pressure is classified as dangerous.

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

The WHO classification in the display shows the range of

•

Move the touch screen activation switch to the ON posi-

the measured blood pressure.

tion.

If the values for systolic and diastolic pressure are in two

•

Make a selection with the MEM button, and then con-

different WHO ranges (e.g. systolic in the grade hyperten-

firm the desired user memory with the START/STOP but-

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

ton . If you press the MEM button again, the aver-

WHO classification on the unit always indicates the higher

age value of all the stored measured values in the user

range (grade hypertension in the example described).

memory will be displayed. If you press the MEM button

again, the average value of the last 7 days for the morning

7. Saving, retrieving and deleting results

measurement will be displayed (Morning: 5 a.m. – 9 a.m.,

•

The results of each successful measurement are stored

display ). If you press the MEM button again, the aver-

together with date and time. With more than 60 items of

age value of the last 7 days for the evening measurement

measured data, the earliest items of data measured are

will be displayed (Evening: 6 p.m. – 8 p.m., display ). If

lost.

you continue to press the MEM button, the most recent

23

individual measured values with date and time are dis-

After 30 seconds of not being in use or if communication

played in turn.

with the PC is interrupted, the blood pressure monitor swit

-

•

You can delete the memory by pressing and holding the

ches itself off automatically

.

MEM button for 3 seconds. All the values in the current

9. Error messages/trouble-shooting

user memory are deleted after three beeps are output.

•

To switch off the device, press the MEM button again or

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

the START/STOP button or push the touch screen acti-

Error messages can occur when

vation switch to OFF.

• systolic or diastolic pressure could not be measured (

•

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

or appears on the display),

automatically after 2 minutes.

• systolic or diastolic pressure was outside the measure-

ment range ( or Lo appears on the display),

8. Transferring measurements

• the cuff is fastened too tightly or loosely ( or

Connect the blood pressure monitor to your PC using the

appears on the display),

USB cable.

• the pump pressure is higher than 300 mmHg (

appears on the display),

No data transfer may be launched whilst performing a

• pumping up takes longer than 160 seconds ( appears

measurement.

on the display),

PC

is shown on the display. Begin the data

• there is a system or device error ( , , or

transfer in the “HealthManager” PC software.

appears on the display),

During the data transfer, an animation is shown

• the batteries are almost empty ,

on the display. A successful data transfer is

f

igure 1

•

the data could not be sent to the PC ( appears in

displayed as in figure 1.

the display).

If the data transfer is unsuccessful, an error

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

message appears as in figure 2. In this case,

move or speak.

interrupt the PC connection and start the data

If necessary, re-insert or replace the batteries.

transfer again.

f

igure 2

24

11. Specifications

Technical alarm – description

Should the recorded blood pressure (systolic or diastolic) lie

Model no. BC 58

outside the limits specified in the section “Technical speci-

Measurement

Oscillometric, non-invasive blood

fications”, the technical alarm will appear on the display

method

pressure measurement on the wrist

indicating either “

” or “Lo”. In such cases, you should seek

Measurement

Cuff pressure 0 – 300 mmHg,

medical assistance and check the accuracy of your proce-

range

systolic 60 – 260 mmHg,

dure.

diastolic 40 – 199 mmHg,

The limit values for the technical alarm are factory set and

Pulse 40 –180 beats/minute

cannot be adjusted or deactivated. These alarm limit val-

Display accuracy

Systolic ± 3 mmHg, diastolic ± 3 mmHg,

ues are accorded second priority under the standard

pulse ± 5 % of the value shown

IEC 60601-1-8.

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

Measurement

Max. permissible standard deviation

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

inaccuracy

according to clinical testing:

matically after about 8 seconds.

systolic 8 mmHg /diastolic 8 mmHg

Memory 2 x 60 memory spaces

10. Cleaning and storing the instrument

Dimensions L 90 mm x W 68 mm x H 30 mm

•

Clean your blood pressure monitor carefully using a

slightly damp cloth only.

Weight Approx. 158 g (without batteries)

•

Do not use detergents or solvents.

Cuff size 140 to 195 mm

•

On no account must you immerse the computer in water,

Permissible operat-

+ 5 °C to + 40 °C, ≤ 90 % relative air

otherwise liquid can enter it and cause demage.

ing conditions

humidity (non-condensing)

•

When storing the device, make sure that no heavy objects

Permissible storage

- 20 °C to + 55 °C, ≤ 95 % relative air

are placed on top of it. Remove the batteries. The cuff

conditions

humidity, 800 –1050 hPa ambient pres

-

tube should not have any sharp kinks.

sure

Power supply

2 x 1,5 V

AAA batteries

25