Unit and LC-display
Intended use
• The Wrist Blood Pressure Monitor is intended to measure the systolic pressure and diastolic pressure,
as well as the pulse rate of adult person via non-invasive oscillometric technique by an inatable cuff
wrapped around the wrist. The unit can be used in medical facilities or at home.
Contraindications
• There are no known contraindications.
Explanation of symbols
0123
IMPORTANT
Follow the instructions for use!
Non-observance of these instructions
can result in serious injury or damage
to the device.
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.
Device classication: type BF
applied part
General prohibition symbol
Keep dry
LOT number
Manufacturer
Date of manufacture
Observe local disposal guidelines!
Medical device
Temperature range
Ambient pressure limitation
Humidity range
Recycling symbols/codes:
These are used to provide information
about the material and its proper use and
recycling.
Do not disassemble or dismantle!
CE sign
This side up
Keep away from sunlight
The device is protected against splash-
ing water. Water splashed against the
enclosure from any direction shall have no
harmful effects.
Serial number
EU authorized representative
IP22
Shenzhen AOJ Medical Technology Co., Ltd.
Add: Room 301&4F, Block A, Building A, Jingfa Intelligent
Manufacturing Park, Xiaweiyuan, Gushu Community, Xixiang Street, Bao’an
District, 518126 Shenzhen, CHINA
Share Info GmbH
Address: Heerdter Lohweg 83, 40549 Düsseldorf, GERMANY
Tel: 0049 179 5666 508; E-mail: [email protected]
GB Safety Instructions
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.
• Only use the unit for its intended purpose in accordance with the instructions for
use. Warranty claims become void if the unit is misused.
• The unit is intended only for use in the home.
• Please consult your doctor prior to using the unit if you suffer from illnesses such
as arterial occlusive disease.
• The unit may not be used to check the heart rate of a pacemaker.
• The result of a blood pressure measurement with this device is not suitable for
self-diagnosis or self-treatment. To avoid health risks, always follow your doctor‘s
instructions and contact him/her for an assessment of the measurement result.
• Never change the intake of medication prescribed by a doctor as a result of a
measurement with this device and consult your doctor for advice on the best time
to take the measurement before measuring.
• The device is not suitable for continuous monitoring of a patient, assessment of an
existing disease or rst aid.
• The device is not suitable for use on patients undergoing surgical treatment and
should only be used in specied locations or in private homes.
• Pregnant women should take the necessary precautions and pay attention to their
individual circumstances. Please consult your doctor if necessary.
• The patient is an intended operator and all the functions can be safely used.
• If you experience discomfort during a measurement, such as pain in the wrist or
other complaints, press the Start/Stop - button
3
to release the air immediately
from the cuff. Loosen the cuff and remove it from your wrist.
• This device is not designed to be used by persons with limited physical, sensory
or mental abilities, or by persons with insufcient 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.
• 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.
Medical devices are not toys!
• Do not let a child below 12 years old or the people who can’t express intention to
use the device.
• Keep the appliance out of the reach of children.
•
The device must not be operated in rooms with high radiation levels or in the vicinity
of devices with high radiation levels, such as radio transmitters, mobile phones or
microwaves, or together with high-frequency surgical devices (magnetic resonance
[MR] devices). This may cause malfunctions or incorrect readings.
• Do not operate near active RF surgical equipment and the RF-shielded room of an
ME system for magnetic resonance imaging where the intensity of EM interference
is high.
• Do not move during the measurement.
•
Protect the unit from moisture. Should liquid nevertheless penetrate the device, the
batteries must be removed immediately and further applications avoided. In this
case, contact your specialist dealer or inform us directly.
•
Never use the unit outdoors or in damp rooms.
•
Do not operate the unit near ammable gas (e.g. narcotic gas, oxygen or hydrogen)
or ammable liquid (e.g. alcohol).
• Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary,
this equipment and the other equipment should be observed to verify that they are
operating normally.
•
Use of accessories, transducers and cables other than those specied or provided
by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
• Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the equipment, including cables specied by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
• Do not make any modications to the unit, do not disassemble it and never
repair the unit yourself. Have repairs carried out only by authorised service
centres.
• Before using the device, it is the user‘s responsibility to determine that the device
is safe and working properly.
• Repeated blood pressure measurements in high numbers can lead to undesirable
side effects, e.g. nerve crushing or blood clots.
• Do not measure more than 3 times in a row and leave at least 5 minutes between
two measurements. Do not measure more than 6 times a day in total.
• Never place the cuff over injured skin, with an existing catheter connection or after
a mastectomy.
• Always keep an eye on the pressure reading on the display. If it exceeds 295
mmHg (39.3 kPa), press the Start/Stop - button
3
immediately to deate the cuff.
• The cuff is delicate and must be handled with care. Only inate the cuff when it is
correctly applied to the wrist.
• Protect the unit from heavy blows and do not drop it. Never use force, e.g. when
putting on the cuff.
• Use only original accessories and spare parts from the manufacturer, otherwise
damage to the unit or personal injury may result.
• Observe the local disposal guidelines if you wish to dispose of the unit.
• If you have any doubts about the proper functioning of the unit, stop using it and
contact the service centre immediately.
• Swallowing small parts such as packaging material, battery, battery compartment
cover, etc. can lead to suffocation. Therefore, never leave children alone with the
unit.
• No maintenance or cleaning may be carried out during operation. Follow the
maintenance and cleaning instructions in this manual.
• People with irregular or unstable peripheral blood circulation due to diabetes, liver
disease, arteriosclerosis, etc. may experience uctuations in the measured blood
pressure values.
• Wash your hands before using the device.
• Do not measure blood pressure when other measurements are being taken on the
same part of the body at the same time, as these may be disturbed or fail.
• If the ambient temperature is less than 5°C or more than 40°C, the waiting time from
minimum storage temperature to use is at least 1 hour; the time from maximum
storage temperature is at least 2 hours.
• Blood pressure values measured with this device are usually slightly lower than
clinically determined values due to the quieter conditions.
• Remove the batteries if you are not using the device for a long time.
• Too frequent measurements can cause injury to the patient due to blood ow
interference.
• The cuff has been tested for biocompatibility, but it varies from person to person,
and some people may still be allergic to the contact material.
• Maintenance should be done by the operator as suggested.
• When the performance changes (such as: inaccurate measurement or abnormal
display), please stop using it immediately and contact the after-sales service
personnel in time.
SAFETY NOTES FOR BATTERIES
• Do not disassemble batteries!
• Replace all batteries if the unit display shows the low battery symbol.
• Never leave any low battery in the battery compartment since it may leak and
cause damage to the unit.
• Increased risk of leakage! Avoid contact with skin, eyes and mucous membranes!
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!
• If a battery has been swallowed, seek medical attention immediately!
• Replace all of the batteries simultaneously!
• Only replace with batteries of the same type, never use different types of batteries
together or used batteries with new ones!
• Insert the batteries correctly, observing the polarity!
• Remove the batteries from the device if it is not going to be used for an extended
period of 3 months or more!
• Keep batteries out of children‘s reach!
• Do not attempt to recharge batteries! There is a danger of explosion!
• Do not short circuit! There is a danger of explosion!
• Do not throw into a re! There is a danger of explosion!
• 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!
Unit and LC-Display
1
Battery compartment
2
LC-Display
3
Start/Stop
4
Wrist cuff
5
User selection / Memory / Settings
6
Blood pressure indicator
7
Time/Date
8
Battery change icon
9
Blood pressure measuring unit
0
Display of Systolic Pressure
q
Display of Diastolic Pressure
w
Display of Pulse Rate
e
Symbol irregular heartbeat
r
Pulse icon
t
Memory number
z
Memory icon
u
Average value
i
User icon 1/2
Scope of delivery
First check that the unit is complete. The scope of delivery includes:
• 1 medisana Blood pressure monitor BW 345
• 2 Batteries (type AAA, LR03) 1.5V
• 1 Storage box
• 1 Instrucion manual
If you notice any transport damage when unpacking, please contact your dealer
immediately.
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 rst 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 relaxed, a second reading is taken – the
diastolic pressure.
Blood pressure classication
Inuencing and evaluating readings
• Measure your blood pressure several times, then record and compare the results.
Do not draw any conclusions from a single reading.
• 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.
• When taking readings, remember that the daily values are inuenced by several
factors.Smoking, consumption of alcohol, drugs and physical exertion inuence
the measured values in various ways.
• Measure your blood pressure before meals.
• Before taking readings, allow yourself at least 5-10 minutes rest.
• 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: Insert / replace batteries
Before you can use your device, you must insert the enclosed batteries. The cover
of the battery compartment
1
is located on the back of the unit. Open it and insert 2
1.5V batteries, type AAA LR03. Pay attention to the polarity (as marked in the battery
compartment). Close the battery compartment again.
Replace the batteries immediately if the battery change symbol
8
appears in the
display or if nothing appears in the display after the unit has been switched on.
User setting
In standby mode, briey press the START/STOP button
3
and the User icon
i
ashes. Then press the “M” button
5
to switch between users 1 or 2
i
. Press the
START/STOP button
3
to conrm the user.
Setting the date, time, measuring unit, Delete stored value
The wrist blood pressure monitor automatically stores up to 199 readings for each
user (1 or 2). The memory function stores the readings with the date and time.
Set the device to the current date and time before taking a measurement for the rst
time. The date and time cannot be changed during a measurement.
1. Press “M” button
5
until the year ashes.
2. Press the “M” button
5
to set the year and then press START/STOP button
3
again to move to the month setting.
3. Press the “M” button
5
again to set the month and proceed analogously for the
day, hour and minute settings. Then press START/STOP button
3
to move to the
measuring unit setting.
4. There are two kinds of units of blood pressure display, mmHg and kPa. mmHg is
set as default measuring unit. Press the “M” button
5
to switch between mmHg/
kPa. Then press the START/STOP button
3
to move to memory setting.
5. Press the “M” button
5
to select which user’s memories need to be deleted.
Then keep pressing the “M” button
5
for 3 seconds to delete the memories of the
selected user and the “NO” icon will appear on the screen. Press the START/STOP
button
3
to end the settings.
6. During these processes, if you want to stop the settings, press the START/STOP
button
3
for 3 seconds to exit the current settings and turn off the device.
WARNING
Please ensure that the polythene packing is kept away from
the reach of children! Risk of suffocation!
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 trafc)!
Fitting the cuff
1. Attach the clean cuff to the left wrist which is free from clothing with the palm of the
hand facing upwards (see illustrations on the left).
2. There should be a gap of approx. 10-15 mm (0.4“-0.6“) between the cuff and the
palm of the hand.
3. Press the Velcro tape rmly around the wrist ensuring that it is not so tight that it
could falsify the measured result.
How to measure correctly
• Perform the measurement while sitting down.
• Relax for 5 to 10 minutes before the measurement.
• Relax your arm and rest it loosely, e.g. on a table.
• Raise your wrist so that the pressure cuff is at heart level (see illustrations on the
left).
• Keep calm during the measurement: do not move and do not talk, otherwise the
measurement results may change.
• Never take a measurement after physical exertion or a bath.
• Keep your legs still during the measurement and do not cross your legs.
• Take the measurement at the same time every day.
• Always use only the original cuff and no spare parts that have not been approved
by the manufacturer.
• Keep your feet at on the oor.
Measure the blood pressure
After you have properly applied the cuff, the measurement can be started:
1. Press the START/STOP button
3
to start the measurement. Automatically, the
device slowly inates the cuff to measure your blood pressure and the display
shows “00“
2. The device will continue to inate the cuff until it reaches a sufcient pressure
for the measurement. The device then slowly deates the cuff and takes the
measurement. As soon as the device detects a signal, the pulse icon
r
starts
ashing in the display.
3. When the measurement is nished, the cuff is deated. The systolic
0
and diastolic
q
blood pressure and the pulse value
w
appear in the display. If the device has
detected an irregular pulse, the symbol for irregular heartbeat
e
also appears.
4. The measured values are automatically stored in the selected user memory (1
or 2). Up to 199 readings can be stored in each user memory. If 199 values are
already stored, the oldest value is overwritten.
Discontinuing a measurement
If it is necessary to interrupt a blood pressure measurement for any reason (e.g. the
patient feels unwell) the START/STOP button
3
can be pressed at any time. The
device immediately decrease the cuff pressure automatically.
Display stored values
In standby mode, press the “M” button
5
button once and the unit displays the
average blood pressure reading for the last three times (“AVG” Average Value Icon
u
lights up). You can then use the “M” button
5
to display other readings.
If you want to delete stored values, please refer to “Setting” section.
Automatic switch-off
If no operation is performed for approx. 20 seconds, the unit switches off automatically.
Error displays
In the event of unusual measurements, the following indications appear on the
display:
Troubleshootng
Problem Cause and solution
No display although the unit
is switched on and batteries
are inserted
The batteries may be empty. Insert new batteries, observing
the polarity. Check whether the unit is defective. If necessary,
contact the customer service.
Measurement cannot be
carried out or air escapes /
no pressure build-up
Put the cuff on correctly. Repeat the measurement after
a 30-minute rest period. Do not talk or move during the
measurement.
Each measurement achieves
widely differing results
Repeat the measurement in the correct manner after a
30-minute rest period. Follow all the instructions given in this
manual for correct measurement and common causes of
incorrect measurements. Slightly deviating results are normal
as blood pressure is subject to constant uctuations.
The measured results differ
greatly from the values
measured by the doctor
Save the measured values and discuss them with your
doctor. It is not uncommon that values not measured at home
can deviate greatly.
If you cannot solve a problem, contact customer service. Do not disassemble the
unit yourself.
Cleaning and care
Remove the batteries before cleaning the device. Clean the unit and the cuff with a
soft cloth lightly moistened with a mild soap solution. Never use harsh detergents,
alcohol, naphtha, thinner or petrol etc.. Do not immerse the unit or any accessories
in water. Make sure that no moisture enters the unit. Do not use the unit again until
it is completely dry. Do not expose the unit to direct sunlight, protect it from dirt and
moisture. Do not expose the unit to extreme heat or cold. Clean the unit once a week.
Store the unit in a clean and dry place according to the environmental conditions for
storage and transport.
Display Cause / Solution
Er U The ination phase takes too long. The ination pressure does not reach 30
mmHg within 12 seconds - please check the correct t of the cuff.
Er H Ination pressure reaches 295 mmHg - automatic deation after 20 ms.
Er 1 No pulse detected.
Er 2 Movement, talking or magnetic interference during the measurement process.
Er 3 Abnormal measurement result.
Er 23 Systolic value below 45 mmHg
Er 24 Systolic value above 230 mmHg
Er 25 Diastolic value below 25 mmHg
Er 26 Diastolic value above 160 mmHg
Disinfection
We recommend disinfecting the unit with a 70% isopropanol solution for approx. 1
minute before and after each use. To do this, proceed as follows:
Disinfect the housing with a soft cloth slightly moistened in the solution and wipe dry
immediately.
Do not disinfect with high-temperature steam or ultraviolet irradiation, as this could
damage the unit or accelerate its ageing!
For any cleaning and disinfection, ensure that the specied ambient conditions for
operation are observed.
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 commercial 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 and standards
This blood pressure monitor complies with the EU standard for non-invasive blood
pressure monitors. It is certied according to EC directives and bears the CE mark
(mark of conformity). The blood pressure monitor complies with the European
regulations EN 60601-1 and EN 60601-1-2. This device is certied in accordance with
EC Guidelines and carries the CE symbol (conformity symbol). The specications of
MDR (EU) 2017/745 are met.
Technical specications
Name and model : medisana Blood pressure monitor BW 345
Display system : Digital display
Memory slots : 2 x 199 for measurement data
Measuring method : Oscillometric
Power supply : 3V
, 2 x 1.5V batteries AAA LR03
Pneumatic pressure measuring range : 0-295 mmHg (0-39 kPa)
Overpressure protection limit : 300 mmHg (40 kPa)
Blood pressure measuring range : Systolic: 45-230 mmHg (6-30.7 kPa);
Diastolic: 25-160 mmHg (3.3-21.3 kPa)
Pulse measuring range : 40-199 beats/min.
Maximum error tolerance for : ± 3 mmHg (± 0.4 kPa)
static pressure
Maximum error tolerance for pulse rate : ± 5 beats/min.
Operation mode : Continous operation
Service life : 5 years
Operating conditions : +5 °C to +40 °C, 15 to 90 % max. relative
humidity, atmospheric pressure: 70-106 kPa
Storage and transport conditions : -20 °C to +55 °C, 10 to 93 % max. relative
humidity, atmospheric pressure: 70-106 kPa.
During transportation or storage, avoid
shocks, direct blows, corrosive gas, exposure
to sunlight or rain. Ensure good ventilation.
Dimensions (L x W x H) : approx. 83.9 x 65.9 x 25.5 mm
Screen size : 40 x 28.5 mm
Cuff : approx. 13.5 - 19.5 cm for adults
Weight : approx. 115 g without batteries
Article number : 48153
EAN number : 40 15588 48153 6
Warranty and repair terms
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.
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.
In accordance with our policy of continual product improvement, we reserve
the right to make technical and visual changes without notice.
GB Instruction manual
Wrist Blood Pressure Monitor
BW 345
48153_BW 345_manual_GB(AUS)_202403_L1
systolic
mmHg
diastolic
mmHg
Classication
≥ 160 ≥ 100 High blood pressure
140 - 159 90 - 99 Mild hypertension
90 - 139 60 - 89 Normal blood pressure
< 90 < 60 too low blood pressure
2 x AAA (LR03) 1,5V
6
7
8
9
1
2
3
5
4
0
q
t
r
z
u
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i
