Common factors
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Proper use
Contraindications
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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 wrist.
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The device
it on
This item
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Explanation of symbols
IMPORT
Follow the
Non-observance of
can result
to the
W
These warning
served to
user
CAUTION
These notes
prevent any
NOTE
These notes
additional information
installation or
Device classification:
applied part
LOT number
Manufacturer
Date of
Keep dry
Please check first of all that the unit is complete.
The following parts are included as standard:
• 1 MEDISANA Blood Pressure Monitor BW 320
• 2 batteries (type
• 1 storage box
• 1 instruction manual
Please contact your supplier if you notice any
transport damage on unpacking the unit.
Scope of supply
Please keep quiet for 5-10 minutes and avoid eating,
drinking alcohol, smoking, exercising and bathing
before taking a measurement.
influence the measurement result.
Remove watches or other spruce from your wrist
before measurement.
Always measure on the same wrist (normally left).
Measurements should be taken regularly at the
same time of each day
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
Extreme temperatures, humidity or altitudes may
impair the performance of the device.
If the wrist is not at heart level, a false reading may
be obtained.
A
With repeated measurements, blood accumulates
in the wrist, what may lead to false readings.
Consecutive blood pressure measurements should
be carried out after a 3-minute pause or after the
arm has been held up in order to allow the accu-
mulated blood to flow normally
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Not to
children (0-3
3
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These values have been specified by the World Health Organisation (WHO) without making
any allowance for age.
Influencing and evaluating readings
•
Measure your
draw any conclusions from a single reading. i
Y
with personal
lues for
When
Smoking, consumption of alcohol, drugs and physical exertion influence the measured
values in various ways. i
Measure your blood pressure
Before taking readings, i
If readings or oc-
casions, 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.
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Starting up
Insert / replace batteries
W
Do not take any therapeutic measures on the basis of a self measure-
ment. Never alter the dose of a medicine prescribed by a doctor
5.
6.
The readings are automatically saved in the selected memory ( or ). Up to 120
measured values with date and time can be stored in each memory. i
The measurement readings
after
using the - button
•
Y the
compartment
LR03
marked inside the battery compartment). i
Close the battery compartment. Replace the batteries immediately if the change battery
symbol
has been switched on.
Setting date and clock
After insertion of the batteries you need to set the date and clock. T enter the setting
mode, press
or 2
Adjust
setting.
same
and procedure Shortly date
pears and
button shortly
entered
Setting up the user memory
The MEDISANA wrist blood pressure monitor BW 320 gives you the opportunity to assign
readings to one of two user memories, each of which provides 120 memory slots. T
the user memory
mory 1 or 2 is flashing. Now press - button to select the user memory or .
Confirm by pressing - button . Y
considered in next blood pressure measurement respectively when the measurement re-
sult is saved. Y
1.
2.
3.
4.
Press the - button to start the measurement. i
The
sure. The rising i
The
the When
device detects starts to i i
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 pres-
sure
blood pressure classification. If the unit has detected an irregular heartbeat, the arrhyth-
mia display will also be shown.
This unit features 2 separate memories,
sults
and the average values
button
memory MR " 1 "
-
have
after approximately 3 min. Memory recall mode can be exited at any time by pres-
sing the
stored Ful "
on
Display Cause
Cleaning and care
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•
Remove
lightly mild soapy use abrasive
naphtha, thinner or gasoline etc.. Never immerse the unit or any component in water.
cautiious not to
tely dry i
Do
the unit to extreme hot or cold temperature. Keep the unit in the storage box when not in use.
Store the unit in a clean and dry location.
The
pressure monitor if you are concerned about health matters. i
Only use the unit for its intended purpose in accordance with the instructions for use.
W
Please consult your
occlusive disease. i
The unit may i
Pregnant take precautions attention
dual circumstances. Please consult your i
If you experience discomfort during a measurement, such as pain in the wrist or other
complaints, press the - button
the cuff and remove it from your wrist. i
Blood
e.g. nerval compression or blood clots.
Blood
marks
cian to get more information.
This
abilities,
vation
use of the device. i
This
Contact your
Do not allow i
Please ensure
The swallowing of small parts like packaging bag, battery battery cover and so on may
cause suffocation. i
The user needs to check that the equipment functions properly and that it is in proper
working condition before being used.
The
high-radiation devices, such as radio transmitters, mobile telephones or microwaves or
together with HF surgical equipment, as this could cause functional defects or incorrect
measurements. i
Do not use the equipment where flammable gas (such as anaesthetic gas, oxygen or
hydrogen) or flammable liquids
Do equipment for
toring. This could lead to disturbances or
Never
In
doctor i
No modification of this unit/device is allowed. i
Please
void
Only use original additional or spare parts from the manufacturer. parts could da-
mage the
Protect
the batteries immediately and do not continue to use the unit. In this case contact your
specialist dealer or notify us directly i
The cuff
properly positioned on i
Protect the i
Please do not use a dilution agent, alcohol or petrol to clean the unit. i
Please do not hit i
If the unit is not going to be used for a long period, please remove the batteries.
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1
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z
t
u
Unit and LC-Display
LC-display - button (Clock/Date) - button (ON/OFF)
- button (Memory recall) Wrist cuf
Blood Pressure Indicator (green - yellow - orange - red) User memory 1/2
Display of Clock / Date Display of Systolic Pressure Unit of measure
Display of Diastolic Pressure
Display of Pulse Rate Change Battery symbol Memory location number
Memory symbol Pulse symbol Blood Pressure Indicator
i
o
M
4
3
1
e
i
o
3
3
M
4
M
z
u
M
4
3
M
4
M
4
ERR1 No pulse was detected.
ERR2 Movement or talking during measurement.
ERR3 Inflation process lasts too long. The cuf
properly
ERR5 Systolic and diastolic pressure are too far apart from each other
measurement. If you constantly receive unusual measurement results, please
contact your doctor
T
Problem Cause and solutions
No display although the
device is switched on and
batteries are inserted
Measurement can not be
proceeded or measure-
ment failed
Each measurement result
strongly deviates from the
one before
The measured values
are remarkably different
from values measured
in a doctors surgery
Maybe the batteries are weak. Insert new batteries and pay
attention to correct polarity
well. In the case of doubt, contact the service centre.
Put on the cuff correctly
relaxing 30 minutes. Do not speak or move during the
measurement.
Repeat the measurement in correct way after relaxing 30
minutes. Pay attention to all the instructions in this manual
and to the common factors of wrong measurements. Slightly
deviating measurement results are quite normal, as the blood
pressure is constantly changing.
Store the measured results and consult your doctor
unusual to measure strongly deviating values outside of your
home.
Please contact the manufacturer resp. the service centre if you can’t solve the problem. Do
not disassemble the unit by yourself.
Grade 3 Hyper-
tension (severe)
Grade 2 Hyper-
tension (moderate)
Grade 1 Hyper-
tension (mild)
7
o
/
T
In accordance with our policy of continual product improvement, we
reserve the right to make technical and visual changes without notice.
G
Read the instruction manual carefully before using
this
keep the
you this device to person, it is
that you also pass on these instructions for use.
Safety Instructions
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SAFETY NOTES FOR BA
Do not disassemble batteries!
Replace all batteries
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 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! i
If a battery has been swallowed, seek medical attention immediately! i
Replace all of the batteries
Only replace with batteries of the same type, never use different types of batteries togeth-
er or used batteries with new ones! i
Insert the batteries correctly
Remove
of 3 months or more! i
Keep batteries out of children's
Do not attempt There is a
Do not short circuit! There is a danger of explosion! i
Do not throw There is
Do into them
container or take them to a battery collection point, at the shop where they were pur-
chased!
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What is blood pressure?
Blood pressure is
heart contracts (= systole) and pumps blood into the arteries, it brings about a rise in pres-
sure. The highest value is known as the systolic pressure and is the first value to be
measured. When the
teries
pressure.
Blood pressure classification WHO
Fitting the cuff
1.
2.
3.
Attach the clean
facing 1 ). i
There should be a gap of approx. 1 cm between the cuf2 ).
Press
falsify 3 ).
Correct position for taking readings
Carry out the measurement
Relax your arm and place it comfortably i
Raise the 4 , a
b = correct, c = too low). i
Keep still during the measurement: Do not move and do not talk as this may alter the
measurements.
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Discontinuing a measurement
If
patient feels unwell) the - button
diately decrease the cuff pressure automatically
T
After the cuff has been appropriately positioned,the measurement can begin:
Display stored values
Delete saved values
If you are sure that you want to permanently remove all stored memories of a user
press and hold the - button for approx. 5 seconds, until CL appears in the display
Release the button. Now press the - button again to confirm the deletion.
Error indicators
The following error codes will appear on the display when a measurement is abnormal:
Disposal
This product must not be disposed of together with domestic waste.
liged
contain
can
before
Guidelines /
This blood
blood
CE
Eur s E 6060 EN 6060 E 6060 E 8060
EN 1060-1, EN 1060-3 and EN 1060-4. The specifications of EU Guideline “93/42/EEC of
the Council Directive dated 14 June 1993 concerning medical devices” are met.
Electromagnetic compatibility: Guidance and manufacturer's declaration
th
(as per 16 November 2017)
hold 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.
Harmonic emissions
IEC 61000-3-2
V
flicker emissions
IEC 61000-3-3
Not applicable
Not applicable
Electromagnetic emissions
RF emissions
CISPR 1
Group 1
The blood pressure monitor is intended for use in the electromagnetic
environment specified belowblood
pressure monitor should ensure that it is used in such an environment.
The
uses
internal
RF
are
interference
electronic
The
is
tablishments
domestic
connected
voltage
that
for
Class B
RF emissions
CISPR 1
Emissions test
Compliance
Electromagnetic
environment-
guidance
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should be
at least 30 %.
Electromagnetic
environment-
guidance
Immunity
test
IEC 60601
test level
Compliance
level
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2 kV/ ±4 kV/
±8 kV/ ±15 kV
air
±8 kV contact
±2 kV/ ±4 kV/
±8 kV/ ±15 kV
air
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 30
The blood pressure monitor is intended for use in the electromagnetic
environment specified belowblood
pressure monitor should ensure that it is used in such an environment.
Electromagnetic immunity
Mains power quality should be
that of a typical commercial
or hospital environment.
Electrical fast
transient / burst
IEC 61000-4-4
± 2 kV for
power supply
lines ; ±1 kV
for input/ out-
put lines
not
applicable
Surge
IEC 61000-4-5
± 1 kV
line to line
±2 kV line to
earth
not
applicable
Mains power quality should be
that of a typical commercial
or hospital environment. If
the user of the blood pressure
monitor requires continued
operation during power mains
dip & interruptions, it is re-
commended that the blood
pressure monitor be powered
from an uninterruptible power
supply or a battery
V
short interruptions
and voltage varia-
tions on power
supply input
lines
IEC 61000-4-1
< 5% U
T
(> 95% dip in
U ) for 0.5
T
cycle;
< 5% U
T
(> 95% dip in
U ) for 1
T
cycle;
70% U
T
(30% dip in
U ) for 25/30
T
cycles;
< 5% U
T
(> 95% dip in
U ) for 5/6 sec
T
NOTE: U is the a.c. mains voltage prior to application of the
T
test level.
not
applicable
a.
Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radios, amateur radio,
broadcast and TV broadcast cannot be predicted theoretically with accuracy
assess the electromagnetic environment due to fixed RF transmitters, an electro-
magnetic site survey should be considered. If the measured field strength in the
location in which the “blood pressure monitor” is used exceeds the applicable RF
compliance level above, the blood pressure monitor should be observed to verify
normal operation. If abnormal performance is observed, additional measures
may be necessary
Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than [V1] 3 V/m.
b.
where P is the maximum output power rating of the trans-
mitter in watts (W) according to the transmitter manu-
facturer and d is the recommended separation distance in
metres (m). Field strengths from fixed RF transmitters,
as determined by an electromagnetic site survey
be less than the comcompliance level in each frequency in
each frequency range. Interference may occur
in the vicinity of equipment marked with the
following Symbol:
a
b
Electromagnetic immunity
Conducted
RF
IEC
61000-4-6
Radiated
RF
IEC
61000-4-3
The blood pressure monitor is intended for use in the electromagnetic
environment specified belowblood
pressure monitor should ensure that it is used in such an environment.
Portable and mobile RF communications
equipment should be used no closer to any part of
the “blood pressure monitor“ including cables than
the recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter
Recommended separation distance:
Electromagnetic environment-
guidance
Immunity
test
Compliance
level
IEC 60601
test level
NOTE 1
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
m
W
150 kHz to 80 MHz
d=1.2 P
80 MHz to 800 MHZ
d=1.2 P
800 MHz to 2.5 GHz
d=2.3 P
0.12
0.38
1.2
3.8
12
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the re-
commended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer
NOTE 1
frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.
The “blood
environment in
customer or
electromagnetic interference
portable and
“blood pressure
maximum output
Recommended separation distances between portable and mobile
RF communications equipment and the blood pressure monitor
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
Separation distance according to frequency of transmitter
Rated maximum
output power
of transmitter
approx.
1 2
3
4
b
a
c
W
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)!
6
t
2
1
2
8
4
M
2
2
M
3
8
2
4
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
Cuff
Dimensions (main unit)
Weight
Item number
EAN number
MEDISANA BW Blood pressure monitor 320
Digital display
2 x 120 measurement values
Oscillometric
3 V=, 2 x 1.5V batteries
30 – 280 mmHg
40 – 200 beats/min.
± 3 mmHg
± 5 % of the value
Automatic with pump
Automatic
After approx. 3 minutes
+5 °C to +40 °C,
15 to 85 % max. relative humidity
-10 °C to +55 °C,
10 to 95 % max. relative humidity
12.5 - 21.5 cm for adults
approx. 75 x 64 x 29 mm (L
approx. 1
51074
40 15588 51074 8
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GB Unit
Blood Pressure Monitor BW 320
Instruction manual - Please read carefully!
2 x LR03
1
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6
5
4
3
2
0
8
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DE/GB
Please contact your supplier or the service centre in case of a claim under the
warranty
state what the defect is.
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.
nonobservance of the user instructions.
b.
unauthorised third parties.
c. Damage which has arisen during transport from the manufacturer to the
consumer or during transport to the service centre.
d.
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.
W
The service centre address is shown on the attached leaflet.
Power magnetic fields should
be at levels characteristic of a
typical location in a typical com-
mercial or hospital environment.
1/2
d=1.2 x P 80 MHz to 800 MHz
1/2
d=2.3 x P 800 MHz to 2.7 GHz
3 V
rms
150 kHz -
80 MHz
6 V
rms in
ISM bands
10 V/m
80 MHz -
2,7 GHz
not appli-
cable
not appli-
cable
10 V/m
80 MHz -
2,7 GHz
385MHz-5785MHz
T
for Enclosure port
immunity to RF wire-
less communication
equipment (Refer to
table 9 of IEC 60601-
1-2:2014)
1/2
d=[3,5/V ] x P
1
