Medisana BW 320 manual

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  • Brand: Medisana
  • Product: Sphygmomanometer
  • Model/name: BW 320
  • Filetype: PDF
  • Available languages: , , , , , , , , , , , , ,

Table of Contents

Page: 1
Common factors of wrong measurements
Proper use
•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.
•The device is not suitable for measuring the blood pressure of children. Ask your doctor before using
it on older children.
This item is not suitable for persons who suffer from a strong arrhythmia.
Explanation of symbols
Follow the instructions for use!
Non-observance of these instructions
can result in serious injury or damage
to the device.
These warning notes must be ob-
served to prevent any injury to the
These notes must be observed to
prevent any damage to the device.
These notes give you useful
additional information on the
installation or operation.
Device classification: type BF
applied part
LOT number
Date of manufacture
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 AAA, LR03) 1.5 V
• 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. All these factors will
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, 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.
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 loose or open cuff causes false readings.
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.
Not to be used by very young
children (0-3 years)!
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 va-
lues for your doctor, you should visit the doctor from time to time to keep him updated. i
When taking readings, remember that the daily values are influenced by several factors.
Smoking, consumption of alcohol, drugs and physical exertion influence the measured
values in various ways. i
Measure your blood pressure before meals. i
Before taking readings, allow yourself at least 5-10 minutes rest. i
If the systolic and diastolic readings seem unusual (too high or too low) on several 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.
Starting up
Insert / replace batteries
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.
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 remain on the display. The unit switches off automatically
after approx. 3 minutes if no buttons are pressed. The unit may also be switched off
using the - button .
You must insert the batteries provided before you can use your unit. The lid of the battery
compartment is located on the left hand side of the unit. Open it and insert the 2 AAA
LR03 type 1.5 V batteries supplied. Ensure correct polarity when inserting the batteries (as
marked inside the battery compartment). i
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.
Setting date and clock
After insertion of the batteries you need to set the date and clock. To enter the setting
mode, press and hold the - button for approx. 3 seconds. Firstly, the user memory 1
or 2 is flashing. Now press the - button again to adjust the correct year figure.
Adjust to correct year by pressing - button and press - button to confirm the
setting. The device now switches to the month setting mode. Proceed accordingly (in the
same way as with the year adjustment) to adjust the correct figures for month, day, hour
and minute. Afterwards, the setting procedure is complete. Shortly, the current date ap-
pears and then the clock appears. If you want to look at the date later on, press the -
button shortly. If the batteries are changed, the set information is lost and needs to be
entered again.
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. To select
the user memory, press and hold the - button for approx. 3 seconds. The user me-
mory 1 or 2 is flashing. Now press - button to select the user memory or .
Confirm by pressing - button . Your selection will be saved by the device and will be
considered in next blood pressure measurement respectively when the measurement re-
sult is saved. Your selection is valid until you make another selection.
Press the - button to start the measurement. i
The device automatically inflates the cuff slowly in order to measure your blood pres-
sure. The rising pressure in the cuff is shown on the display. i
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.
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 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 arrhyth-
mia display will also be shown.
This unit features 2 separate memories, each with a capacity of 120 memory slots. Re-
sults are automatically stored in the memory selected by the user. Press the - button i
and the average values of the last 3 measurements appear on the display. Press the -
button again and the latest stored measurement value will be shown, together with the
memory symbol "MR" and the memory location place "1" . Repeatedly pressing the
- button displays the respective values measured previously (MR2, MR3 and so on). If you
have reached the final entry and do not press a button, the unit automatically switches itself off
after approximately 3 min. Memory recall mode can be exited at any time by pres-
sing the - button . The oldest value is deleted, if 120 measured values have been
stored in the memory and a new value is saved - at the same time, "Ful" shortly appears
on the display.
Display Cause
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,
naphtha, 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 comple-
tely dry. Only inflate the cuff when it is in position around the wrist. i
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 storage box when not in use.
Store the unit in a clean and dry location.
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. i
Only use the unit for its intended purpose in accordance with the instructions for use.
Warranty claims become void if the unit is misused. i
Please consult your doctor prior to using the unit if you suffer from illnesses such as arterial
occlusive disease. i
The unit may not be used to check the heart rate of a pacemaker. i
Pregnant women should take the necessary precautions and pay attention to their indivi-
dual circumstances. Please consult your doctor if necessary. i
If you experience discomfort during a measurement, such as pain in the wrist or other
complaints, press the - button to release the air immediately from the cuff. Loosen
the cuff and remove it from your wrist. i
Blood pressure measurements in high repetition rates may lead to unwanted side effects,
e.g. nerval compression or blood clots. i
Blood pressure measurements - especially if executed frequently - may lead to temporary
marks on the skin and / or to blood circulation disorders. If necessary, contact your physi-
cian to get more information. i
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 obser-
vation by a person responsible for their safety, or unless they have been instructed in the
use of the device. i
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. i
Do not allow children to use the unit. Medical products are not toys! i
Please ensure that the unit is kept away from the reach of children. i
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. i
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 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 (such as alcohol) are present. i
Do not take measurements, if any other equipment is applied to the same limb for moni-
toring. This could lead to disturbances or failures. i
Never apply the cuff over hurt skin, in case of an inserted catheter or after a mastectomy.
In cases of cardiac irregularity (arrhythmia) only use this device after consultation of your
doctor. i
No modification of this unit/device is allowed. i
Please do not attempt to repair the unit yourself in the event of malfunctions, since this will
void all warranty claims. Only have repairs carried out by authorised service centres. i
Only use original additional or spare parts from the manufacturer. Other parts could da-
mage the device or could lead to personal injury. i
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. i
The cuff is very sensitive and needs to be handled with care. Only inflate the cuff when it is
properly positioned on the wrist. i
Protect the device from dirt, direct sunlight and extreme temperatures. i
Please do not use a dilution agent, alcohol or petrol to clean the unit. i
Please do not hit the device heavily or let if fall down from a high place. i
If the unit is not going to be used for a long period, please remove the batteries.
1 2 3
4 5 6
7 8
9 q
w e
r z
Unit and LC-Display
LC-display - button (Clock/Date) - button (ON/OFF)
- button (Memory recall) Wrist cuff Lid of the Battery Compartment
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 Arrhythmia display (arrhythmia cordis)
Display of Pulse Rate Change Battery symbol Memory location number
Memory symbol Pulse symbol Blood Pressure Indicator
i o
M 4
M 4
ERR1 No pulse was detected.
ERR2 Movement or talking during measurement.
ERR3 Inflation process lasts too long. The cuff probably has not been positioned
ERR5 Systolic and diastolic pressure are too far apart from each other. Repeat the
measurement. If you constantly receive unusual measurement results, please
contact your doctor.
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. Check, if the device is working
well. In the case of doubt, contact the service centre.
Put on the cuff correctly. Repeat the measurement after
relaxing 30 minutes. Do not speak or move during the
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. It is not
unusual to measure strongly deviating values outside of your
Please contact the manufacturer resp. the service centre if you can’t solve the problem. Do
not disassemble the unit by yourself.
Display area
Grade 3 Hyper-
tension (severe)
≥ 180 ≥ 110 Red
Grade 2 Hyper-
tension (moderate)
160 - 179 100 - 109 Orange
Grade 1 Hyper-
tension (mild)
140 - 159 90 - 99 Yellow
High - Normal 130 - 139 85 - 89 Green
Normal 120 - 129 80 - 84 Green
Optimal < 120 < 80 Green
7 o
Technical specifications
In accordance with our policy of continual product improvement, we
reserve the right to make technical and visual changes without notice.
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
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 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 simultaneously! i
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, observing the polarity! i
Remove the batteries from the device if it is not going to be used for an extended period
of 3 months or more! 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 pur-
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 pres-
sure. 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 ar-
teries also falls. Once the arteries are relaxed, a second reading is taken – the diastolic
Blood pressure classification WHO
Fitting the cuff
Attach the clean cuff to the left wrist which is free from clothing with the palm of the hand
facing upwards (fig.1). i
There should be a gap of approx. 1 cm between the cuff and the palm of the hand (fig.2).
Press the Velcro tape firmly around the wrist ensuring that it is not so tight that it could
falsify the measured result (fig.3).
Correct position for taking readings
Carry out the measurement whilst seated. i
Relax your arm and place it comfortably, on a table for instance. i
Raise the wrist so that the cuff of the monitor is at heart level (fig. 4, position a = too high,
b = correct, c = too low). i
Keep still during the measurement: Do not move and do not talk as this may alter the
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 imme-
diately decrease the cuff pressure automatically.
Taking a blood pressure measurement
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:
This product must not be disposed of together with domestic waste. All users are ob-
liged 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 house-
Guidelines / Standards
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”. The blood pressure monitor corresponds to
European standards EN 60601-1, EN 60601-1-2, EN 60601-1-11, EN 80601-2,
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
(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
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
Not applicable
Electromagnetic emissions
RF emissions
CISPR 11 Group 1
The blood pressure monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the blood
pressure monitor should ensure that it is used in such an environment.
The “blood pressure monitor”
uses RF energy only for its
internal function. Therefore, its
RF emissions are very low and
are not likely to cause any
interference in nearby
electronic equipment.
The “blood pressure monitor”
is suitable for use in all es-
tablishments other than
domestic and those directly
connected to the public low-
voltage power supply network
that supplies buildings used
for domestic purposes.
Class B
RF emissions
Emissions test Compliance
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should be
at least 30 %.
IEC 60601
test level
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2 kV/ ±4 kV/
±8 kV/ ±15 kV
±8 kV contact
±2 kV/ ±4 kV/
±8 kV/ ±15 kV
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m 30 A/m
The blood pressure monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the blood
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
IEC 61000-4-5
± 1 kV
line to line
±2 kV line to
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.
Voltage dips,
short interruptions
and voltage varia-
tions on power
supply input
IEC 61000-4-11
< 5% UT
(> 95% dip in
U ) for 0.5
< 5% UT
(> 95% dip in
U ) for 1
70% UT
(30% dip in
U ) for 25/30
< 5% UT
(> 95% dip in
U ) for 5/6 sec
NOTE: U is the a.c. mains voltage prior to application of the
test level.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
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, such as reorienting or relocating the “blood pressure monitor”.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than [V1] 3 V/m.
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, should
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:
Electromagnetic immunity
The blood pressure monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the blood
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-
IEC 60601
test level
NOTE 1 At 80 MHz and 800 MHz, the higher 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.
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
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, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher
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 pressure monitor” is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The
customer or the user of the blood pressure monitor can help prevent
electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the
“blood pressure monitor” as recommended below according to the
maximum output power of the communications equipment.
Recommended separation distances between portable and mobile
RF communications equipment and the blood pressure monitor
Separation distance according to frequency of transmitter
Rated maximum
output power
of transmitter
approx. 1 cm
1 2
3 4
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)!
Name and model
Display system
Memory slots
Measuring method
Power supply
Blood pressure measuring
Pulse measuring range
Maximum error tolerance for
static pressure
Maximum error tolerance for
pulse rate
Pressure generation
Automatic switch-off
Operating conditions
Storage conditions
Dimensions (main unit)
Item number
EAN number
Blood pressure monitor 320
Digital display
2 x 120 measurement values
3 V=, 2 x 1.5V batteries AAA LR03
30 – 280 mmHg
40 – 200 beats/min.
± 3 mmHg
± 5 % of the value
Automatic with pump
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 x W x H)
approx. 117 g without batteries
40 15588 51074 8
GB Unit and LC-Display
Blood Pressure Monitor BW 320
Instruction manual - Please read carefully!
2 x LR03, 1.5 V, AAA
8 9
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
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.
d=1.2 x P 80 MHz to 800 MHz
d=2.3 x P 800 MHz to 2.7 GHz
3 Vrms
150 kHz -
80 MHz
6 Vrms in
ISM bands
10 V/m
80 MHz -
2,7 GHz
not appli-
not appli-
10 V/m
80 MHz -
2,7 GHz
Test specifications
for Enclosure port
immunity to RF wire-
less communication
equipment (Refer to
table 9 of IEC 60601-
d=[3,5/V ] x P

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