Beurer BM 44: ENGLISH

ENGLISH: Beurer BM 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 upper arm blood pressure monitor is used for non-

Follow instructions for use

invasive measurement and monitoring of adults‘ arterial

blood pressure.

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).

14

Manufacturer

15

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

Cardiovascular diseases may lead to incorrect measure-

ments or have a detrimental effect on measurement ac-

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

SN Serial number

diabetes, circulatory disorders and arrhythmias as well as

The CE labelling certifies that the product

chills or shaking.

complies with the essential requirements

The blood pressure monitor must not be used in connec-

0483

of Directive 93/42/EEC on medical prod-

tion with a high-frequency surgical unit.

ucts.

Only use the device on people who have the specified up-

per arm measurement for the device.

Please note that when inflating, the functions of the limb

Advice on use

in question may be impaired.

In order to ensure comparable values, always measure

During the blood pressure measurement, blood circulation

your blood pressure at the same time of day.

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

Before every measurement, relax for about five minutes.

device malfunctions, remove the cuff from the arm.

If you want to perform several measurements on the same

Avoid any mechanical restriction, compression or bending

person, wait five minutes between each measurement.

of the cuff line.

Do not take a measurement within 30 minutes after eating,

drinking, smoking or exercising.

Do not allow sustained pressure in the cuff or frequent

Storage and Care

measurements. The resulting restriction of the blood flow

may cause injury.

The blood pressure monitor is made up of precision elec-

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

tronic components. Accuracy of readings and the instru-

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

ment’s service life depend on careful handling.

intravascular access or therapy, or an arteriovenous (AV)

You should protect the device from impact, moisture,

shunt.

dirt, major temperature fluctuations and direct exposure

Do not use the cuff on people who have undergone a

to the sun’s rays.

mastectomy.

Never drop the device.

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

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

ther injury.

it away from any radio systems and mobile phones.

You can either use the blood pressure monitor with batter-

Do not press the start/stop button before the cuff is

ies or with a mains part. Please note that data transfer and

placed on.

data storage is only possible when your blood pressure

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

monitor is supplied with power. As soon as the batter-

going to be used for a longer period of time.

ies are empty or the mains part is disconnected from the

Advice on batteries

power supply, the blood pressure monitor loses the date

and time.

Batteries can be fatal if swallowed. You should therefore

To conserve the batteries, the monitor switches off auto-

store the batteries and products where they are inaccessi-

matically if no buttons are pressed for one minute.

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

The device is only intended for the purpose described in

a doctor immediately.

these instructions for use. The manufacturer is not liable

Batteries should not be charged or reactivated with any

for damage resulting from improper or careless use.

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

the fire or short-circuited.

Remove the batteries from the instrument if they are worn

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

16

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

3. Unit description / Icons in the display

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

1

Never use different types of battery, battery brands or bat-

3

teries with different capacities. You should preferably use

2

alkaline batteries.

Repair and disposal

Batteries do not belong in domestic refuse. Used batteries

should be disposed of at the collection points provided.

Never open the instrument. If these instructions are not

heeded, the warranty will be null and void.

Never attempt to repair the instrument or adjust it your-

self. We can no longer guarantee perfect functioning if you

do.

Repairs may only be performed by Customer Service or

authorized dealers. However, always check the batteries

and replace them if necessary prior to making any com-

plaint.

The appliance should be disposed of according to

Regulation 2002/96/EC-WEEE (Waste Electrical

1. Cuff tube

and Electronic Equipment). In case of queries,

2. Cuff

please contact the municipal authorities responsible for

3. Cuff connector

waste disposal in your area.

17

4. Prepare measurement

WHO

Inserting battery

12

1

Remove the battery cover

SYS

11

mmHg

from the back of the moni-

tor.

10

2

Insert four AA 1.5 V alkaline

DIA

9

mmHg

batteries. making absolutely

PUL

sure that you insert them

/min

3

with the correct polarity

8

as marked. Never use re-

4

chargeable batteries.

7

Replace the battery cover carefully.

5

6

If the battery change

is continuously illuminated, meas-

urement is no longer possible and you must replace all the

1. Mains part port

batteries.

2. Systolic pressure

Used batteries do not belong in the household waste. You

3. Diastolic pressure

are legally obliged to dispose of the batteries. Dispose of

4. Pulse

them via your specialist electrical supplier or local collec ting

5. Pulse symbol

point for recyclable waste.

6. Battery compartment

Note: Batteries containing pollutant

7. Start-/stop-button

substances are marked as follows:

8. Battery replacement symbol

Pb = Battery contains lead, Cd = Battery

9. Deflate arrow

contains cadmium, Hg = Battery contains

10. Arrhythmia recognition

mercury.

11. Cuff connector port

12. WHO classification indication

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Operation with the mains part

Positioning cuff

You can also operate this device with a mains part.

Fit the cuff round your bare left

When doing so, there must not be any batteries in the bat-

upper arm. Blood circulation in the

tery compartment. The mains part can be obtained from

arm should not be restricted by

specialist retailers or from the service address using order

tight clothing or other objects.

number 071.19.

To prevent possible damage to the device, the blood

The cuff should be placed on the

pressure monitor must only be used with the mains part

upper arm so that the lower edge is

described here.

2 to 3 cm above the bend of the

Insert the mains part into the connection provided for this

elbow and above the artery. The

purpose on the right-hand side of the blood pressure mo-

tube should be in line with the

nitor. The mains part must only be connected to the mains

centre of the palm.

voltage that is specified on the type plate.

Then insert the mains plug of the mains part into the

Now place the free end of the

mains socket.

cuff snugly, but not too tightly,

After using the blood pressure monitor, unplug the mains

around the arm, and fix it with the

part from the mains socket first and then disconnect it

Velcro fastener. The cuff should be

from the blood pressure monitor. As soon as you unplug

fitted tight enough to allow just two

the mains part, the blood pressure monitor loses the date

fingers to fit beneath the cuff.

and time setting but the saved measurements are retai-

Insert the cuff tubing into the

ned.

socket for the cuff attachment.

5. Measuring blood pressure

Please ensure the device is at room temperature before

measuring.

19

Important: The instrument should only be operated with the

Measuring blood pressure

original cuff. The cuff is suitable for an arm circumference of

Switch on the blood pressure monitor with the start/stop

22 to 30 cm.

button

.

A larger cuff for upper arm circumferences from 30 to 42 cm

Before the measurement, the last saved test result is brief-

is available from retailers or the service address under order

ly displayed. If there is no measurement in the memory,

no. 162.795.

the instrument always displays the value

.

The cuff automatically inflates. Cuff air pressure is re-

Correct posture

leased slowly.

If a tendency towards high blood pressure is already

detectable, the cuff is pumped up again and cuff pressure

increased further. As soon as a heart rate is detected, the

heart rate symbol

is displayed.

Heart rate, systolic and diastolic blood pressure are dis-

played.

Rest for approx. 5 minutes before each measurement.

You can interrupt measurement at any time by pressing

Otherwise there may be divergences.

the start/stop button

.

You can perform the measurement either sitting or lying

_ appears if it has not been possible to perform the

down. Always make sure that the cuff is on a level with

measurement properly. Observe the section in these in-

your heart.

structions on error messages/troubleshooting and repeat

To carry out a blood pressure measurement, make sure

the measurement.

you are sitting comfortably with your arms and back lean-

The test result is saved automatically.

ing on something. Do not cross your legs. Place your feet

To switch off and release the pressure, press the start/

flat on the ground.

stop button

again. If you forget to switch off the device,

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

it switches off automatically after approx. 1 minute.

during the measurement and not talk.

Wait at least 5 minutes before taking another measurement!

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Evaluating results

However, these standard values serve only as a general

Cardiac arrhythmia:

guideline, as the individual blood pressure varies in different

people and different age groups etc.

This instrument can identify possible cardiac arrhythmia dis-

It is important to consult your doctor regularly for advice.

orders during measurement and if necessary indicates the

Your doctor will tell you your individual values for normal

measurement with the flashing icon

.

blood pressure as well as the value above which your blood

This may be an indicator for arrhythmia. Arrhythmia is a

pressure is classified as dangerous.

condition where the heart rhythm is abnormal as a result

of defects in the bioelectrical system controlling the heart

Range of blood

Systolic

Diastolic

Measure

beat. The symptoms (omitted or premature heart beats,

pressure values

(in mmHg)

(in mmHg)

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

Grade 3:

>= 180 >= 110 Seek medical

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

Severe hyper-

advice

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

tension

Arrhythmia can only be ascertained through examination by

Grade 2:

160 – 179 100 – 109 Seek medical

your doctor.

Moderate

advice

Repeat the measurement if the flashing icon

is dis-

hyper tension

played after the measurement. Please note that you should

rest for 5 minutes between measurements and not talk or

Grade 1: Mild

140 – 159 90 – 99

Have it checked

move during the measurement. If the icon

appears

hypertension

regularly by doctor

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

High normal 130 – 139 85 – 89

Have it checked

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

regularly by doctor

vital to follow your doctor’s instructions.

Normal 120 – 129 80 – 84 Check it yourself

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 indicate

lowing table.

the range of the blood pressure which has been recorded.

21

If the values for systolic and diastolic pressure are in two

Technical alarm – description

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

Should the recorded blood pressure (systolic or diastolic)

and diastolic pressure in the normal range) the graphic WHO

lie outside the limits specified in the section “Technical

classification on the unit indicates the higher range (high-

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

normal in the example described).

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

seek medical assistance and check the accuracy of your

6. Error messages / trouble-shooting

procedure.

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

The limit values for the technical alarm are factory set and

Error messages may appear if:

cannot be adjusted or deactivated. These alarm limit val-

systolic or diastolic pressure could not be measured (

ues are accorded second priority under the standard IEC

or

appears on the display)

60601-1-8.

systolic or diastolic pressure was outside the measure-

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

ment range (Hi” or “Lo appears on the display)

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

the cuff is fastened too tightly or loosely ( or ap-

matically after about 8 seconds.

pears on the display)

the pump pressure is higher than 300 mmHg ( ap-

7. Cleaning and care

pears on the display)

Clean your device and cuff carefully only with a slightly

pumping up takes longer than 160 seconds ( appears

moistened cloth.

on the display)

Do not use any detergents or solvents.

there is a system or device error ( , , or

Never hold the instrument under water as otherwise liquid

appears on the display)

can penetrate and damage the instrument.

the batteries are almost empty .

Never place any heavy objects on the instrument.

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

move or speak.

If necessary, re-insert or replace the batteries.

22

8. Technical details

Battery life For approx. 600 measurements, depend-

Model no. BM 44

ing on the blood pressure level and/or

pump pressure

Measurement

Oscillometric, non-invasive blood pres-

method

sure measurement on the upper arm

Accessories Instruction for use, 4 x 1.5 V AA batteries,

storage pouch

Measurement

Cuff pressure 0 300 mmHg,

range

systolic 60 – 260 mmHg,

Classification Internal supply, IPX0, no AP or APG,

diastolic 40 –199 mmHg,

continuous operation, type BF applied

Pulse 40 –180 beats/minute

part

Display accuracy Systolic ± 3 mmHg,

Technical information is subject to change without notifica-

diastolic ± 3 mmHg,

tion to allow for updates.

pulse ± 5 % of the value shown

Measurement

Max. permissible standard deviation

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

inaccuracy

according to clinical testing:

and is subject to particular precautions with regard to

systolic 8 mmHg /diastolic 8 mmHg

electromagnetic compatibility (EMC). Please note that

portable and mobile HF communication systems may in-

Dimensions L 94 mm x W 122 mm x H 53 mm

terfere with this unit. More details can be requested from

Weight Approx. 230 g (without batteries)

the stated Customer Service address or found at the end

Cuff size 22 to 30 cm

of the instructions for use.

Permissible oper-

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

This device is in line with the EU Medical Devices Directive

ating conditions

humidity (non-condensing)

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

Devices Act) and the standards EN1060-1 (non-invasive

Permissible stor-

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

sphygmomanometers, Part 1: General requirements),

age conditions

humidity, 800 –1050 hPa ambient pressure

EN1060-3 (non-invasive sphygmomanometers, Part 3:

Power supply

4 x 1,5 V

AA batteries

Supplementary requirements for electro-mechanical blood

pressure measuring systems) and IEC 80601-2-30 (Medi-

cal electrical equipment – Part 2 30: Particular require-

23

ments for the safety and essential performance of auto-

Enclosures

Equipment enclosed to protect against

mated non-invasive blood pressure monitors).

and Protective

contact with live parts, and with parts which

The accuracy of this blood pressure monitor has been

Covers

can become live (finger, pin, hook test).

carefully checked and developed with regard to a long

The operator shall not contact the patient

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

and the output plug of AC mains part simul-

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

taneously.

priate means. Precise instructions for checking accuracy

may be requested from the service address.

9. Mains part

Model no. FW 7575M/EU/6/06

Input 100 – 240 V, 50 – 60 Hz

Output 6 V DC, 600 mA, in connection with Beurer

blood pressure monitor

Supplier Friwo Gerätebau GmbH

Protection This device is double insulated and pro-

tected against short circuit and overload by

a primary thermal fuse. Make sure to take

the batteries out of the compartment before

using the mains part.

double insulated / equipment class 2

Polarity of the the DC voltage connection

24