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are backed by our comprehensive 3 Year Warranty.
Please fill in and return the Warranty Card to the address
provided.
General information 2
• Please read these operating instructions thoroughly and
follow them and the safety notes in particular before using
the appliance for the first time!
• Anything done to or with this appliance may only be
undertaken as described in the operating instructions.
• If you pass on your device to someone else, always include
the operating instructions.
5
Safety instructions 3
• This device is not intended to be used by individuals with
limited physical, sensory or intellectual abilities or limited
experience, and/or a lack of knowledge (including
children), unless they are being supervised by an individual
responsible for their safety or receive instructions from
them concerning how the device must be used.
• Children should be supervised in order to ensure that they
do not play with the device.
• Keep the device and its accessories out of reach of small
children.
• Keep the packing materials, such as foil away from
children. The danger of suffocation could arise in the case
of misuse.
• The device is suitable for healthy adults. Use the unit for
comparative measurements, particularly during sporting
activities. Do NOT use the unit for medical diagnosis. It can
not replace medical intervention.
• Only start the air supply (ON/OFF button) once the unit is
attached correctly.
• Do not drop the unit and do not place objects on top of it.
• Never immerse the unit in water. Do not expose it to water
or moisture!
6
•Do not use the device under extreme temperature
conditions!
• Do not bend the fixed part of the sleeve!
Batteries and Proper Treatment
Batteries may contain combustible materials. By misuse, this
may cause battery leakage, heat, explosion or ignition,
bringing about injury or damage to the device.
Please observe strictly the following matters:
• The unit is battery-operated. Batteries may endanger life if
swallowed. For these reasons, keep the unit out of reach of
children. If a battery is swallowed, please obtain immediate
medical assistance.
• Clean the battery and device contacts, if necessary, before
inserting batteries.
• Do not charge batteries (except rechargeable batteries).
• Do not forcibly discharge batteries.
• Do not short-circuit batteries.
• Do not heat or dispose off in fire.
• Do not disassemble or deform batteries. Your hands and
fingers may be injured, or the liquid of the battery may get
into your eyes or adhere to your skin. If this happens, rinse
with a large quantity of water immediately and consult a
doctor.
• Do not expose batteries to strong impact by dropping or
throwing the batteries.
7
•Do not reverse the positive (+) and negative (-) terminals to
avoid short-circuit.
• Do not mix used and new or different types of batteries
together.
• Remove the used batteries promptly from the device.
• Remove the batteries from your device if it is not to be
used for a long period.
• Replace all batteries with new batteries of the same type at
the same time.
Disposal
• Your device is packaged to protect it against damage
during transportation. The packaging is manufactured
from materials that can be sent to a specialist recycling
facility and disposed of in an environmentally-friendly way.
• At the end of its life, the appliance must not be disposed of
in household rubbish.
• Do not dispose of used batteries in the household rubbish!
They must be deposited at a collection point for used
batteries.
Repair
• Leave all repairs of your device to authorized and qualified
personnel only.
8
•Never try to open and/or repair the unit yourself. Repairs
may only be undertaken by our Service Centre or other
appropriate specialist workshop.
About this device 4
Purpose of use
The device is used to measure blood pressure at the wrist. It
is suitable for healthy people above 14 years of age and can
be used to make comparative measurements – especially
during sporting activities.
The memories are stored in two units, and each unit can
store 60 memories at most.
This device is only suitable for using in dry, internal rooms.
This device is intended for personal use only. It is not
intended to commercial use in a heavy industry
environment. Use under extreme environmental conditions
can result in damage to your device.
If the values obtained give you cause to be concerned
about your health, take medical advice. Do not
change your treatment/dosage of medication as a
result of the values unless you have discussed this
with your doctor!
9
Blood pressure values
When interpreting the values measured, please note that
there can be differences in the values measured at the wrist
and arm. However, because the values measured at the
upper arm and wrist undergoes the same changes the
values measured at the wrist can be used for comparative
measurements.
The blood pressure measurement device displays blood
pressure (systolic and diastolic values), pulse, date and time.
The following summary can help you to assess the values
you measure.
The classification of blood pressure values is based on a
definition and classification by the WORLD HEALTH
ORGANISATION from 1999. The WHO defines high blood
10
pressure as values above 140 mmHg (systolic value) and
90 mmHg (diastolic value).
The new blood pressure classification indicator visually
indicates user’s blood pressure category,
Blood pressure
classification
Low < 90 < 50 Green
Normal 91 - 129 51 - 84 Green
High-Normal 130 -139 85 - 89 Green
systolic
mmHg
diastolic
mmHg
Colourindicator
Hypertension
stage I
Hypertension
stage II
Hypertension
stage III
140 – 159 90 – 99 Yellow
160 – 179 100 – 109 Orange
> 180 > 110 Red
11
Overview and Display 5
1. Colour indicator
2. Battery icon, the battery icon appears if the batteries
need to be changed.
3. Time
4. Date (M month; D day)
M: Memory button: save measured blood values, set date
5.
and time,
6. Power button: Start measurement,
confirm date and time setting.
12
1. Memory sign
2. Number of measurement (01 – 60)
01 last measurement, 02 previous measurement, etc.
3. Blood pressure classification
4. Pulse sign
5. Pulse frequency per minute
6. Diastolic pressure display
Display of the memory unit (
7. Systolic pressure display,
8. Irregular heartbeat indication
U1/U2)
13
Getting started 6
Inserting the batteries
1. Remove the cover of the battery compartment in the
direction of the arrow.
2. Insert two 1.5V batteries size AAA/LR03 (alkaline). Pay
attention to the polarity (the negative terminal faces
the spring).
3. Close the battery compartment.
Replace the batteries
• if the battery icon appears on the display,
• if the display remains blank after pressing the ON/OFF
button.
Replace all batteries with new batteries of the same
type at the same time. Do not mix used and new or
different types of batteries together.
Rechargeable batteries are not suitable for the
operation of this device.
14
Setting the date and time
1. Press the buttons and M at the same time.
The current month flashes.
2. Press the M button repeatedly to set the current month.
3. Press the
4. Press the
5. Press the button. The hour flashes.
6. Press the M button repeatedly to set the current hour.
7. Press the button. The minutes flash.
8. Press the M button repeatedly to set the current minutes.
Date and time have been set. The flashing bar disappears
after 10 seconds.
9. Press the button to finish the date and time setting.
The device closes the setting mode automatically after one
minute.
button. The day flashes.
M button repeatedly to set the current day.
15
Usage 7
1. Attach the wrist sleeve in such a
way that it is approx. 5 – 10 mm
away from the palm of your left
hand (see fig. B). Ensure that no
articles of clothing are trapped
in the sleeve.
2. Hold the lower part of the sleeve
as shown in fig. C. Pull down and
wrap it around and upwards, so
that there is no gap between the
sleeve and your wrist.
3. Use your thumb to hold the
sleeve cover while you wrap it
upwards.
4. Wrap the sleeve according to
the shape of your wrist. If the
sleeve is not firmly attached the
pressure will increase and the
wrist will become numb. Correct
measurement is then no longer
possible.
16
If the sleeve cannot be attached to your left arm and if it is
not possible to measure your left arm, use your right one.
Attach the sleeve as shown in fig. D.
17
Correct measurement 8
Place your elbow on the table or other supporting surface,
and hold your arm so that the wrist sleeve is at heart height.
In doing so, support your lower arm on the storage box or
on a folded towel or similar.
To measure your blood pressure, sit comfortably on a chair,
take 5 or 6 deep breaths and relax.
Always measure your blood pressure at the same time each
day! It is important to measure your blood pressure at home
and at the same time each day so that the blood pressure,
which can change over the course of a day, is recorded
properly.
18
Inform your doctor of the values measured so that he can
give you medical advice.
Blood pressure measured at the wrist can vary from that
measured at the upper arm. The values may be slightly
different because of the different measurement positions
and the strength of the blood vessels in the wrist and upper
arm. In many cases, the difference for healthy people can be
±10 mmHg of the systolic and diastolic blood pressure.
Attention is advised for the following types of person:
People with high blood pressure, diabetes, liver
disease, hardened arteries, poor circulation.
Carrying out measurements
1. Attach the wrist sleeve to your wrist as described above.
2. Press the button.
All indicators are displayed for a few seconds on the
screen; then the screen shows the time and the most
recently selected memory unit (
3. You can modify the current memory unit by pressing the
M.
button
If you have already stored measurements in this unit the
display shows the latest values.
U1/U2).
19
During measurement do not move the sleeve or your
arm or hand muscles.
A few seconds later the monitor starts searching the zero
point. When the air pressure is stable the monitor begins to
measure automatically.
4. If you want to stop the measurement, press the
button. The air is released from the sleeve.
If you want to repeat a measurement you should wait
at least five minutes. The air must be completely
removed from the sleeve.
Automatic Measurement
Measurement starts automatically; the device pumps up the
sleeve. If the sleeve pressure is too low the device pauses
and pumps up the sleeve again until it reaches a sleeve
pressure that is appropriate for the measurement.
The device also measures your pulse. The value displayed
will fall during measurement.
The sleeve deflates when the measurement is complete. The
systolic and diastolic blood pressure and the pulse with the
pulse icon appear in the display.
20
Indication of an irregular heartbeat
(arrhythmia)
The pulse normally beats evenly (rhythmically). The symbol
will appear in the display if the device perceives
irregularities in the rhythm of the pulse.
Repeat the measurement in this case.
There can be different causes of irregularities in the rhythm
of the pulse. Please consult your doctor if your pulse is
arrhythmic in the long term.
If you want to repeat a measurement you should wait
at least five minutes. The air must be completely
removed from the sleeve.
21
Memory unit 9
Reading the stored values
The device has two memory units U1 and U2. Up to 60
measurements can be saved in each unit. You can also
display the average values of the saved measurements.
1. The device should not be in measure mode. Switch it off
if necessary.
2. Press the button M to enter the memory mode.
On the display appear the memory sign, the memory unit
and the number of measurements, which have been
stored in this unit.
3. You can modify the current memory unit by pressing the
button.
4.
Press the button M to display the stored values.
5.
The measured values are displayed in reverse order. With
each press of the button
M the previous results appear.
6.Press the button to exit the memory.
22
The saved values remain saved when the device is
switched of with the
button.
Deleting memory
1. Press the button M to enter the memory mode.
On the display appear the memory sign, the memory unit
and the number of measurements, which have been
stored in this unit.
2. Select the memory unit you want to delete by pressing
button.
the
3. Press the button M for more than 2 seconds.
A control tone signalizes the deletion. On the display
appear two bars.
The values of the selected memory unit are deleted.
23
Cleaning and maintenance 10
Notes on maintenance
It is recommended that you check the usability of the unit
every three years.
Cleaning and storage
Clean the device with a soft, lint-free cloth. Do not use any
solvents, corrosive or gaseous cleaning agents.
Store and transport the device in the storage box supplied.
Do not bend the preshaped sleeve outwards. The sleeve
should neither be washed nor dry cleaned.
If the appliance is not going to be used for long periods,
remove the batteries.
24
Error messages 11
Defect Possible cause and solution
The batteries are dead Replace both batteries
Er 0
Er 1
Er 2
Er 3
Er 4
Pressure system is
unstable before
measurement
Systolic pressure
detect fail
Diastolic pressure
detect fail
Pneumatic system
blocked or cuff is too
tight during inflation.
Pneumatic system
leakage or cuff is too
loose during inflation
with 2 new 1.5V, LR03/
AAA batteries
Take the measurement
again. Don’t move and
don’t speak during the
measurement.
Place the cuff correctly
and try again.
25
Defect Possible cause and solution
Er 5
Er 6
Er 7
Er 8
Er 9
Er A
Inflation above
300 mmHg
Over 3 minutes while
pressure above
15 mmHg
EEPROM accessing
error
Device parameter
check error
MCU self-verity error
Span error
Take the measurement
again after a 5 minute
break.
Contact the service
centre if the error is
indicated repeatedly
over a long period of
time.
If you detect failures on the display or wrong measurements, remove the batteries and replace them after 1
minute.
26
Technical Data 12
Measurement method: oscillometric
Measuring range: Blood pressure: 30 ~ 250 mmHg
Pulse: 40 ~ 180 beats/min.
Power supply: 2 x 1.5 V batteries size LR03/AAA
(alkaline)
Display: LCD
Memory space: 2 x 60 measurement results
Pressure built up: automatically by pump
Air release: automatically via one-way valve
Measuring accuracy +/- 3 mmHg pressure indicator
Operating temperature: +5 ~ +40 °C
air humidity < 80 %
Storage temperature: -20 ~ +55 °C,
air humidity < 95 %
Weight: ca. 108 g (excluding batteries)
Sleeve size: 14 ~ 19.5 cm
Subject to technical changes.
27
The product meets the requirements of the guideline
93/42/EWG for medical devices.
The device corresponds with standards EN 1060-1: 1995 and
EN 1060-3: 1997 for non-invasive blood pressure measuring
devices.
Type B
The device was manufactured in 2008.
0197
The serial number is arranged inside the battery
compartment.
28
Appendix 13
Table 201
Guidelines and manufacturer's declaration –
electromagnetic emissions
Model MD 15231 is designed for operation in an environment as
described below: The customer or user of Model MD 15231 should
ensure that it is operated in such an environment.
Interference
emission
measurements
HF emissions
according to
CISPR 11
In line
with
Group 1 Model MD 15231 uses HF energy
Electromagnetic environment
guidelines
exclusively for its internal operation.
Therefore its HF emission is very low and
it is unlikely that nearby electronic devices
should suffer interference.
29
Interference
emission
measurements
HF emissions
according to
CISPR 11
Emission of
harmonics
according to IEC
61000-3-2
Emission of
voltage fluctuations/flicker
according to IEC
61000-3-3
In line
with
Class B
Not
applicable
Not
applicable
Electromagnetic environment –
guidelines
Model MD 15231 is intended for use in
all premises including residential areas
and those that are directly connected
to public supply networks that also
supply buildings that are used for
residential purposes.
Table 202
Guidelines and manufacturer's declaration –
electromagnetic interference immunity
Model MD 15231 is intended for operation in an electromagnetic
environment as described below: The customer or user of Model
MD 15231 should ensure that it is operated in such an environment
30
Interference
immunity
tests
Electrostatic
discharge
(ESD)
according to
IEC 61000-4-2
Fast, transient
electrical
interference/
bursts according to IEC
61000-4-4
Voltage
surges according to IEC
61000-4-5
IEC 60601-
test level
± 6 kV
contact
discharge
± 8 kV
air discharge
± 2 kV for
supply lines
± 1 kV for
input and
output lines
± 1 kV
bipolar
voltage
± 2 kV
unipolar
voltage
Pass level Electromagnetic
environment – guidelines
N± 8 kV
Air discharge
Floors should be of wood or
concrete or laid with
ceramic tiles.
If the floor is covered with
synthetic material, the
relative humidity should be
at least 30%.
Not
applicable
The quality of the power
supply should match that
of a typical business or
hospital environment.
Not
applicable
The quality of the power
supply should match that
of a typical business or
hospital environment.
31
Interference
immunity
tests
Voltage dropouts, shortterm breaks
and drops in
supply
voltage
according to
IEC 61000-411
IEC 60601-
test level
1)
< 5 % U
T
2
40 % U
)
T
3)
70 % U
T
4)
< 5 % U
T
Pass level Electromagnetic
environment – guidelines
Not
applicable
The quality of the power
supply should match that
of a typical business or
hospital environment. If the
user of Model MD 15231
requires continued
operation even if power
supply drop-outs occur, we
recommend supplying
Model MD 15231 from an
uninterruptible power
supply or a battery.
Magnetic
field at the
power
frequency
(50/60 Hz)
3 A/m Not
applicable
Magnetic fields at the mains
frequency should match
the typical values found in
business or hospital
environments.
according to
IEC 61000-4-8
Note: VT is the main AC voltage befor application of the test level.
1)
(> 95 % drop in VT) for ½ period
2)
(60 % drop in V T) for 5 periods
3)
(30 % drop in VT) for 25 periods
4)
(> 95 % drop in VT) for 5 s
32
Table 204
Guidelines and manufacturer's declaration –
electromagnetic stability
Model MD 15231 is designed for operation in an electromagnetic
environment as described below: The customer or user of Model MD
15231 should ensure that it is operated in such an environment.
Electromagnetic environment – guidelines
Portable and mobile should not be used closer to the [appliance or system]
than the protection distance calculated using the equation applicable for
the emission frequency.
Interference
immunity
tests
Conducted
HF
interference
according to
IEC 61000-4-6
Radiated HF
interference
according to
IEC 61000-4-3
IEC 60601-
test level
3 V
eff
150 kHz to
80 MHz
3 V/m
80 MHz to
2,5 GHz
Pass level Recommended
protection distance:
3 V
eff
3 V/m
d = 1,17 1/V *
d = 1,17 m/V *
80 MHz to 800 MHz
d = 2,33 m/V *
800 MHz to 2,5 GHz
33
Interference
immunity
tests
IEC 60601-
test level
Pass level Recommended
protection distance:
Where P is the transmitter's nominal output in Watt (W) according to the
information provided by the manufacturer of the transmitter and d is the
recommended protection distance in metres (m).
The field strength at all frequencies of stationary transmitters is, according
to an on-site inspection
a
, below the pass level b. Interference may be
experienced in the vicinity of appliances marked with the following symbol
NOTE 1: The higher applies at 80 MHz and 800 MHz.
NOTE 2: These guidelines may not apply to all situations. The radiation of
electromagnetic waves is influenced by absorption and reflection
from buildings, objects and people.
a
The field strength of stationary transmitters, such as base stations for
radio telephones and terrestrial mobile services, amateur stations, AM
and FM radio and television transmitters cannot be determined precisely
in theoretical terms. In order to determine the electromagnetic
environment resulting from stationary HF transmitters we recommend
an on-site inspection. If the field determined at the location of Model MD
15231 exceeds the pass level stated above the Model MD 15231 must be
checked for normal operation at each point of use. If unusual performance characteristics are observed, it may be necessary to undertake
additional measures such as realigning or moving Model MD 15231.
b
Not applicable in the frequency range from 150 kHz to 80 MHz.
34
Table 206
Recommended protective distances between
portable and mobile HF telecommunication devices and the
[DEVICE or SYSTEM]
Model MD 15231 is intended for operation in an electromagnetic
environment in which the HF interference is controlled. The customer or
user of Model MD 15231 can help to avoid electromagnetic interference by
adhering to the minimum distance between portable and mobile HF
telecommunication devices (transmitters) and the Model MD 15231 –
depending on the output of the communication device as shown below.
Nominal
output of
trans-
mitter W
0.01 N/A N/A 0.12 0.23
0.1 N/A N/A 0.38 0.73
1 N/A N/A 1.2 2.3
10 N/A N/A 3.8 7.3
100 N/A N/A 12 23
Protective distance depending on the transmission
frequency m
150 kHz to 80 MHz
150 kHz to 80 MHz
outside the
ISM bands
within the
ISM bands
80 MHz to
800 MHz
d = 1.2
800 MHz to
d = 2.3
2.5 GHz
35
For transmitters whose nominal output is not listed in the above table, the
distance can be determined using the equation in the relevant column,
where P is the transmitter's maximum nominal output in Watt (W) as
specified in the information provided by the transmitter's manufacturer.
NOTE 1 The higher frequency range applies at 80 MHz and 800 MHz.
NOTE 2 The ISM frequency bands (for industrial, scientific and medical
applications) between 150 kHz and 80 MHz are 6.765 MHz to 6.795
MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz and
40.66 MHz to 40.70 MHz.
NOTE 3 The pass levels in the ISM frequency bands between 150 kHz and
80 MHz and in the frequency range from 80 MHz and 2.5 GHz are
intended to reduce the probability that mobile/portable
communication devices might cause interference if they are
accidentally brought into the patient area. For this reason the
additional 10/3 factor is applied when calculating the
recommended protection distances in these frequency ranges.
NOTE 4 These guidelines may not apply to all situations. The radiation of
electromagnetic waves is influenced by absorption and reflection
from buildings, objects and people.
36
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