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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.
1.
2.
3.
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
green
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.
6.
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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.
GB
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!
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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
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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
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•
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.
GB
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)
2
3
1
1 2
3
4
5
7
AM
PM
1
2
4 x LR03, 1.5 V, AAA
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8 9
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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.
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Unit and LC-Display
o
Insert / replace batteries
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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.
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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.
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Fitting the cuff
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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).
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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
4.
5.
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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