Manual Medisana BU 535 Voice (page 2 of 6) (English, German, Dutch, French, Italian, Turkish)

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WARNING

Blood pressure that is too low represents just as great a health

risk as blood pressure that is too high! Fits of dizziness may

lead to dangerous situations arising (e.g. on stairs or in trafﬁc)!

Do not take any therapeutic measures on the basis of a self

measurement. Never alter the dose of a medicine prescribed

by a doctor.

This blood pressure monitor meets the requirements of the EU standard for

non-invasive blood pressure monitors. It is certiﬁed in accordance with EC

Guidelines and carries the CE symbol (conformity symbol) “CE 0297”. i

The speciﬁcations of EU Guideline “93/42/EEC of the Council Directive dated 14

June 1993 concerning medical devices” are met. The blood pressure monitor

corresponds to European standards: EN 60601-1:2005 +A1:2012(E)/EN 60601-

1：2006/A11: 2011, EN80601-2-30:2009+AMD1：2013/EN 80601-2-

30:2010/A1：2015, EN 1060-1: 1995 + A2: 2009, EN 1060-3: 1997 + A2:2009.

Electromagnetic compatibility: The device complies with the EN60601-1-

2:2007/EN 60601-1-2:2007 /AC:2010 standards for electromagnetic compatibility.

You can ﬁnd details on this measurement data on the seperate enclosure.

systolic diastolic

mmHg mmHg

≥ 180 ≥ 110

160 - 179 100 - 109

140 - 159 90 - 99

130 - 139 85 - 89

120 - 129 80 - 84

< 120 < 80

severe hypertension

moderate hypertension

mild hypertension

high-normal blood pressure

normal blood pressure

optimal blood pressure

red

orange

yellow

green

Blood Pressure Indi-

cator /

2 u

Switch the unit on by pressing the - button . The display will shortly show all

available symbols.

The MEDISANA blood pressure monitor BU 535 / BU 535 Voice gives you the

opportunity to assign readings to one of two user memories, each of which

provides 120 memory slots. After switching on the device, press the M - button

, to choose between user 1 and user 2. If no selection is made within 5

seconds, the following measurement will be assigned to the current shown user.

The last value measured for this user is shown in the display (if no value is

available „0" is shown). The device now starts to deﬂate the cuff completely - the

symbol for zero pressure search is shown in the display.

The readings are automatically saved in the selected memory ( or ).

Up to 120 measured values with date and time can be stored in each me-

mory along with time and date.

The measurement readings remain on the display. The unit switches off

automatically after approx. 1 minute if no buttons are pressed. The unit

may also be switched off using the - button .

Delete saved values

If you want to delete the saved measurements of a user, ﬁrst follow the ins-

tructions under "Display stored values" to display any record of the user. Now

press and hold the M - button for approx. 3 seconds, The display will show „CL“

and „00" and the values are deleted.

The service centre address is shown on the attached leaflet.

Read the instruction manual carefully before

using this device, especially the safety

instructions, and keep the instruction manual

for future use. Should you give this device to

another person, it is vital that you also pass on

these instructions for use.

Safety Instructions

Ÿ The unit is intended only for use in the home. Consult your doctor prior to using

the blood pressure monitor if you are concerned about health matters.

Ÿ Only use the unit for its intended purpose in accordance with the instructions

for use. Warranty claims become void if the unit is misused.

Ÿ Please consult your doctor prior to using the unit if you suffer from illnesses

such as arterial occlusive disease.

Ÿ The unit may not be used to check the heart rate of a pacemaker.

Ÿ Like on any other oscillometric blood pressure measurement devices, certain

medical conditions can affect the measurement accuracy, among others:

cardiac arrhythmias, low blood pressure, circulatory disorders, states of shock,

diabetes, pregnancy, pre-eclampsy etc. Always consult a physician before you

use the device.

Ÿ This device is not suitable to provide a medical diagnosis. The measurement

results are for reference only. Contact your physician to get information about

treatment and medicine, which are necessary for you.

Ÿ The arrhythmia function does not replace a professional cardiac examination.

Check with your doctor if any treatment or medical action is necessary for you.

Ÿ Irregularity of pulse or arrhythmia can lead to difﬁculties in recording a correct

reading when measurements are taken using oscillometric blood pressure

devices. This device is electronically equipped to detect arrhythmia which it

indicates with the icon . In this case, contact your physician.

Ÿ Please contact your physician about the speciﬁc risks of cuff pressure in your

individual case.

Ÿ If you experience discomfort during a measurement, such as pain in the upper

arm or other complaints or in case the device does not stop to inﬂate the cuff,

press the - button to release the air immediately from the cuff. Loosen

the cuff and remove it from your arm.

Ÿ Blood pressure measurements in high repetition rates may lead to unwanted

side effects, e.g. nerval compression or blood clots.

Ÿ Blood pressure measurements - especially if executed frequently - may lead to

temporary marks on the skin. These marks may be visible for several days in

individual cases. If necessary, contact your physician to get more information.

Ÿ This device is not designed to be used by persons with limited physical,

sensory or mental abilities, or by persons with insufﬁcient experience and/or

knowledge, unless under observation by a person responsible for their safety,

or unless they have been instructed in the use of the device.

Ÿ This device is intended to be used by adults. The unit is unsuitable for children

or babies. Contact your doctor, if you want to use this device on young persons.

Ÿ Do not allow children to use the unit. Medical products are not toys!

Ÿ The swallowing of small parts like packaging bag, battery, battery cover and

so on may cause suffocation.

Ÿ The user needs to check that the equipment functions properly and that it is in

proper working condition before being used.

Ÿ The device needs to be used in accordance to the speciﬁed ambient conditions

(see "Technical speciﬁcations") only. Otherwise the accuracy of readings

might be affected.

Ÿ Do not use the device in moving vehicles.

Ÿ The device may not be operated in rooms with high levels of radiation or in the

vicinity of high-radiation devices, such as radio transmitters, mobile

telephones or microwaves, as this could cause functional defects or incorrect

measurements.

Ÿ Do not use the equipment where ﬂammable gas (such as anaesthetic gas,

oxygen or hydrogen) or ﬂammable liquids (such as alcohol) are present.

Ÿ Contact your physician before using the device, if:

- the cuff should be applied over hurt or burned skin

- the cuff should be applied on limbs with an inserted catheter or shunt

- the cuff should be applied on the same side of the body where a

mastectomy has been realized

- a blood pressure measurement should be executed together with other

measurements on the same part of the body

- a control of the blood circulation of the user is necessary

Ÿ Never use any other cuff than the one supplied and do not use the cuff together

with other persons to avoid infections.

Ÿ Do not apply the cuff on any other part of the body than the left upper arm.

Ÿ The cuff must not be applied over clothes as this may lead to injuries or

inaccurate readings.

Ÿ Do not kink or fold the cuff and do not pull it over sharp edges.

Ÿ No modiﬁcation of this unit/device is allowed.

Ÿ Do not disassemble the device.

Ÿ Avoid high temperatures and direct sunlight.

Ÿ Protect the unit against moisture. If liquid does manage to penetrate into the

unit, remove the batteries immediately and do not continue to use the unit. In

this case contact your specialist dealer or notify us directly.

Ÿ Please do not attempt to repair the unit yourself in the event of malfunctions.

Only have repairs carried out by authorised service centres.

Ÿ If the device has been stored at cool temperatures, you should allow some time

to acclimatise at room temperature before using.

Ÿ Please do not use a dilution agent, alcohol or petrol to clean the unit.

Ÿ Do not hit the device heavily or let if fall down from a high place.

Ÿ Do not insert any objects into the device openings and never push the buttons

with heavy force or with the help of peak objects. This may lead to damages of

the device.

Ÿ If the unit is not going to be used for a long period, please remove the batteries.

SAFETY NOTES FOR BATTERIES

Do not disassemble batteries! i

Replace all batteries if the unit display shows the low battery symbol. i

Never leave any low battery in the battery compartment since it may leak and

cause damage to the unit. i

Increased risk of leakage! Avoid contact with skin, eyes and mucous mem-

branes! If battery acid comes in contact with any of these parts, rinse the

affected area with copious amounts of fresh water and seek medical attention

immediately! i

If a battery has been swallowed, seek medical attention immediately! i

Replace all of the batteries simultaneously! i

Only replace with batteries of the same type, never use different types of

batteries together or used batteries with new ones! i

Insert the batteries correctly, observing the polarity! i

Keep batteries out of children's reach! i

Do not attempt to recharge batteries! There is a danger of explosion! i

Do not short circuit! There is a danger of explosion! i

Do not throw into a ﬁre! There is a danger of explosion! i

Do not throw used batteries into the household refuse; put them in a

hazardous waste container or take them to a battery collection point, at the

shop where they were purchased!

•

Upper arm cuff Blood Pressure Indicator (green - yellow - orange - red)

LC-display - button (START/STOP) M - button (Memory Recall)

Battery compartment (on underside) Push-in Connector for air tube

Display of time Display of date Display of Systolic Pressure

Display of Diastolic Pressure Display of Pulse Rate

Pulse symbol Symbol for zero pressure search

Memory Location number M - symbol (memory)

Blood Pressure Indicator Change Battery symbol User memory

Arrhythmia display (arrhythmia cordis)

What is blood pressure?

Blood pressure is the pressure created in the blood vessels by each heart beat.

When the heart contracts (= systole) and pumps blood into the arteries, it brings

about a rise in pressure. The highest value is known as the systolic pressure

and is the ﬁrst value to be measured. When the cardiac muscle relaxes to take

in fresh blood, the pressure in the arteries also falls. Once the arteries are re-

laxed, a second reading is taken – the diastolic pressure.

How is blood pressure measured?

The MEDISANA BU 535 Voice is a blood pressure unit which is used to

measure blood pressure at the upper arm. The measurement is carried out by a

microprocessor, which, via a pressure sensor, measures the vibrations resulting

from the inﬂation and deﬂation of the cuff over the artery.

Blood pressure classiﬁcation WHO

These values have been speciﬁed by the World Health Organisation (WHO)

without making any allowance for age.

Inﬂuencing and evaluating readings

•

Measure your blood pressure several times, then record and compare the

results. Do not draw any conclusions from a single reading. i

Your blood pressure readings should always be evaluated by a doctor who is

also familiar with your personal medical history. When using the unit regularly

and recording the values for your doctor, you should visit the doctor from time

to time to keep him updated. i

If the systolic and diastolic readings seem unusual (too high or too low) on

several occasions, despite correct use of the unit, please inform your doctor.

This also applies to the rare occasions when an irregular or very weak pulse

prevents you from taking readings.

•

Starting up

You must insert the batteries provided before you can use your unit. The lid of the

battery compartment is located on the underside of the unit. Open it by pushing

the cover outward and remove it. Insert the 4 AAA LR03 type 1.5 V batteries sup-

plied. Ensure correct polarity when inserting the batteries (as marked on the

battery compartment cover).

Close the battery compartment. Replace the batteries immediately, if the change

battery symbol appears on the display or if nothing appears on the

display after the unit has been switched on.

Taking a blood pressure measurement

After the cuff has been appropriately positioned,the measurement can begin:

Discontinuing a measurement

If it is necessary to interrupt a blood pressure measurement for any reason

(e.g. the patient feels unwell) the - button can be pressed at any time.

The device immediately decrease the cuff pressure automatically.

Display stored values

This unit features 2 separate memories, each with a capacity of 120 memory

slots. Results are automatically stored in the memory selected by the user.

To call up the measured values stored, press the M - button when the device is

switched on to activate the memory recall mode. A user memory ( or ) along

with the number of saved values is shown. Change the user memory with the -

button . Press the M - button to show the average values of the last 3

measurements of this user (along with „A3"). With each press on the M - button

the display proceeds to show the average values for all measurements of this user

memory (“AL“), the average value of the measurement results of the last 7 days

taken between 5 o‘clock and 9 o‘clock in the morning (“AM“) and the average value

of the measurement results of the last 7 days taken between 6 o‘clock and 8 o‘clock

in the evening (“PM“).

Now press the M - button again to display the last measurement value of the

user. Repeatedly pressing the M - button displays the respective values

measured previously. If no further values are saved, the display will show a „0". If

no button is pressed, the unit automatically switches itself off after approximately 1

minute. Memory recall mode may also be exited at any time by pressing the -

button , which will also switch the unit off. The oldest value is deleted if 120

measured values have been stored in the memory and a new value is saved.

Error messages and error remedying

The following notiﬁcations in the display indicate problems or errors:

Disposal

This product must not be disposed of together with domestic waste. All

users are obliged to hand in all electrical or electronic devices, regardless

of whether or not they contain toxic substances, at a municipal or commer-

cial collection point so that they can be disposed of in an environmentally

acceptable manner.

Remove the batteries before disposing of the device/unit. Do not dispose of

old batteries with your household waste, but at a battery collection station at

a recycling site or in a shop. Consult your local authority or your supplier for

information about disposal.

Guidelines / Standards

Name and model

Display system

Memory slots

Measuring method

Power supply

Blood pressure measuring range

Pulse measuring range

Maximum error tolerance for

static pressure

Maximum error tolerance for

pulse rate

Pressure generation

Deflation

Automatic switch-off

Operating conditions

Storage conditions

Dimensions (main unit)

Cuff

Weight

Item number

EAN number

Acessories

MEDISANA Blood pressure monitor

BU 535 Voice

Digital display

2 x 120 measurement values

Oscillometric

6 V=, 4 x 1.5V batteries AAA LR03

40 – 260 mmHg

40 – 180 beats/min.

± 3 mmHg

± 5 % of the value

Automatic with pump

Automatic

After approx. 1 minute

+10 °C to +40 °C, ≤ 85 % relative humidity;

Air pressure 80 kPa - 105 kPa

-20 °C to +50 °C, ≤ 85 %. relative humidity;

Air pressure 80 kPa - 105 kPa

Approx. 150 x 95 x 41 mm (L x W x H)

22 - 36 cm for adults

Approx. 235 g without batteries

51178

40 15588 51178 3

- Cuff M 22 - 36 cm for adults with

average upper arm circumference

Art. No. 51135 / EAN 40 15588 51135 6

- Cuff, L 30 - 42 cm for adults with upper

arm of large circumference

Art. No. 51126 / EAN 40 15588 51126 4

Technical specifications

In accordance with our policy of continual product improvement, we

reserve the right to make technical and visual changes without notice.

The current version of this instruction manual can be found under

www.medisana.com

Please contact your supplier or the service centre in case of a claim under the

warranty. If you have to return the unit, please enclose a copy of your receipt and

state what the defect is.

The following warranty terms apply:

1. The warranty period for MEDISANA products is 3 years from date of purchase.

In case of a warranty claim, the date of purchase has to be proven by means

of the sales receipt or invoice.

2. Defects in material or workmanship will be removed free of charge within the

warranty period.

3. Repairs under warranty do not extend the warranty period either for the unit

or for the replacement parts.

4. The following is excluded under the warranty:

a. All damage which has arisen due to improper treatment, e.g.

nonobservance of the user instructions.

b. All damage which is due to repairs or tampering by the customer or

unauthorised third parties.

c. Damage which has arisen during transport from the manufacturer to the

consumer or during transport to the service centre.

d. Accessories which are subject to normal wear and tear as batteries etc..

5. Liability for direct or indirect consequential losses caused by the unit are

excluded even if the damage to the unit is accepted as a warranty claim.

Warranty and repair terms

MEDISANA GmbH, Jagenbergstr. 19, 41468 NEUSS, GERMANY.

E-mail: info@medisana.de, Internet: www.medisana.com

Proper use

Contraindications

•

The device is not suitable for measuring the blood

pressure of children. Ask your doctor before using

it on older children.

This device is not suitable for persons who suffer

from strong arrhythmia.

•

This fully automatic electronic blood pressure

monitor is intended for measuring the blood

pressure at home. It is a non-invasive blood

pressure measurement system to measure the

diastolic and systolic blood pressure and pulse of

an adult using a non-invasive technique by means

of a cuff, which needs to be ﬁtted on the upper arm.

The cuff size is limited to 22 - 42 cm.

Instruction Manual

Please read carefully!

Please check ﬁrst of all that the unit is complete.

The following parts are included as standard:

• 1 MEDISANA Blood pressure monitor BU 535

Voice

• 4 batteries (type AAA, LR03) 1,5V

• 1 cuff with air tube

• 1 storage pouch

• 1 instruction manual

Please contact your supplier if you notice any

transport damage on unpacking the unit.

Scope of supply

Explanation of symbols

Blood Pressure Monitor BU 535 Voice

GB Unit and LC-Display

DE/GB

1-2 cm

(a)

(b)

(c)

1 2

4 x LR03, 1.5 V, AAA

8 9

ertz

IMPORTANT

Follow the instructions for use!

Non-observance of these instructions

can result in serious injury or damage

to the device.

Device classiﬁcation: type BF applied part

LOT number

Manufacturer

Date of manufacture

WARNING

These warning notes must be observed

to prevent any injury to the user.

CAUTION

These notes must be observed to prevent

any damage to the device.

NOTE

These notes give you useful additional

information on the installation or

operation.

Common factors of wrong measurements

•

Please keep quiet for 5-10 minutes and avoid eating,

drinking alcohol, smoking, exercising and bathing

before taking a measurement. All these factors will

inﬂuence the measurement result.

Remove any garment that ﬁts closely to your

upper arm.

Always measure on the same arm (normally left).

Measurements should be taken regularly at the

same time of each day, as the blood pressure varies

even during the day.

Any effort to support the arm during measurement

may increase the measured blood pressure.

Make sure, you are in a comfortable, relaxed posi-

tion and do not move or constrict your muscles

during measurement. Use a cushion to support your

arm if necessary.

If the arm artery lies lower or higher than the heart,

a false reading will be obtained.

A loose or open cuff causes false readings.

With repeated measurements , blood accumulates

in the arm which can lead to false reading.

Consecutive blood pressure measurements should

be repeated after 1.5-minute pause or after the

arm has been held up in order to allow the

accumulated blood to ﬂow away.

•

Unit and LC-Display

Insert / replace batteries

Settings: Display format, date, time

For a correct operation of the device it is necessary to set time and date.

Immediately after inserting the batteries the device is in setting mode for 1 minute.

Afterwards, it will switch to standby-mode. You may enter the setting mode at any

time by pressing and holding the - button and the M - button at the same

time for approx. 2 seconds. In setting mode, ﬁrstly the clock format (12 or 24 hours

format) can be set. The value can be adjusted with the M - button . Press the -

button afterwards to enter the date and time setting mode. Adjust the year,

month, day, hour and minute ﬁgure in sequence. You may adjust the ﬂashing value

by pressing M - button and conﬁrm the value and go to next step by pressing the

- button . After the minutes have been set and - button is pressed, all

adjustments have been done and the device will switch itself to standby mode

again. If no button is pressed during approx. 1 minute during the setting process,

the device will automatically switch to standby-mode. If the batteries are changed,

the set information is lost and needs to be entered again.

Setting the voice language

The MEDISANA Blood pressure monitor BU 535 Voice features a voice output. To

adjust a language, press and hold the M - button during the clock display mode.

„L0", „L1" or similar appears in the display - the „0" represents a deactivated voice

output and the other ﬁgures represent a language as follows:

1 = German 2 = English 3 = Dutch

4 = French 5 = Italian 6 = Turkish

Hold the M - button pressed down, until the desired language is set and then

release the button. After the language is selected, you may use the M - button

again in the same way to adjust the output volume.

Fitting the cuff

Push the end piece of the air tube into the hole on the left side of the unit

prior to use. i

Slide the open end of the cuff through the metal bracket so that the Velcro

fastener is on the outside and it becomes a cylindrical form (Fig.1). Slide the

cuff over your left upper arm. i

Position the air hose in the middle of your arm in line with your middle ﬁnger

(Fig.2) (a). The lower edge of the cuff should be 2 - 3 cm above the crease of

the elbow. (b). Pull the cuff tight and close the Velcro fastener (c). i

Measure the pulse on your bare arm. i

Only position the cuff on the right arm if it cannot be used on the left arm. Al-

ways carry out measurements on the same arm. i

Correct measuring position for sitting (Fig.3).

Notiﬁcation

Cause and correction

Hi or Lo

The measurement result is out of the measurable

range. Repeat the measurement and contact your

physician if necessary.

Unusual

measurement

results

Cuff not ﬁtted properly; Movement or speaking

during measurement; Incorrect body posture; Heart

arrhythmia. Repeat the measurement and contact

your physician if necessary.

Replace all batteries.

Er 0 / Er 1 / Er 2

Pressure system instable at start of the

measurement / Error in measuring the systolic

pressure / Error in measuring the diastolic pressure.

Do not move!

Er 3 / Er 4

Pressure system is blocked or sleeve is too tight

during inflation / Pressure system has a leak or

sleeve is too loose during inflation

Put the sleeve on correctly!

Er 5 / Er 6 / Er 7 /

Er 8 / Er A

Sleeve pressure above 300 mmHg / Longer than

160 seconds with sleeve pressure over 15 mmHg /

EEPROM access error / Error when testing the

functions on the device / Failure of pressure sensor

Perform measurement again after 5 minutes!

No reaction after

pressing a button or

insertion of batteries

Remove the batteries, wait for 5 minutes and re-

insert the batteries.

Please contact the manufacturer resp. the service centre if you can’t solve the

problem. Do not disassemble the unit by yourself.

Cleaning and care

Remove the batteries before cleaning the unit. Clean the unit and the cuff using

a soft cloth lightly moistened with a mild soapy solution. Never use abrasive

cleaning agents, alcohol, naphta, thinner or gasoline etc.. Never immerse the

unit or any component in water. Be cautiious not to get any moisture in the main

unit. Do not use the unit again until it is completely dry. Only inﬂate the cuff when it is

in position around the upper arm.

Do not expose the unit to direct sunlight; protect it against dirt and moisture. Do not

subject the unit to extreme hot or cold temperature. Keep the unit in the

original packing when not in use. Store the unit in a clean and dry location.

Servicing and calibration:

The unit has been calibrated by the manufacturer for a period of two years’ use. In

the case of commercial use, the unit must be serviced and recalibrated at least

once every two years. This calibration will be charged for and can be carried out by

an appropriate authority or an authorised service centre - in accordance with the

regulations for users of medical equipment. The device is designed for maintaining

the safety and performance characteristics for a minimum of 10,000

measurements resp. 3 years. The cuff integrity is maintained after 1,000 open-

close cycles of the closure.

WARNING

The unit is now ready for measurement and it automatically inﬂates the cuff

slowly in order to measure your blood pressure. The rising pressure in the cuff is

shown on the display. The unit inﬂates the cuff until sufﬁcient pressure has built

up for a measurement. Then the unit slowly releases air from the cuff and carries

out the measurement. When the device detects the signal, the heart symbol

starts to ﬂash on the display.

When the measurement is ﬁnished, the cuff is deﬂated completely. The

systolic and diastolic blood pressure and the pulse value appear on the

display . The blood pressure indicator is shown next to the relevant

coloured bar depending on the WHO blood pressure classiﬁcation. If the unit

has detected an irregular heartbeat, the arrhythmia display will also

be shown.

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Medisana BU 535 Voice Manual

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