750.168 0616_SBC21 FZN SBC21

2017-07-05

: Kogan Fzn-Sbc21 FZN-SBC21 usermanuals files

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D
Blutdruckmessgerät
:
Gebrauchsanweisung .............................................. 2 – 11
G
Blood pressure monitor
Instructions for use .............................................. 12 – 20
F
Tensiomètre
Mode d’emploi ......................................................21 – 30
I
Misuratore di pressione
Istruzioni per l’uso .................................................31 – 40
r
Прибор для измерения кровяного
давления на запястье
Инструкция по применению .............................. 41 – 52
Electromagnetic Compatibility Information ............. 53 – 55
SBC 21
0483
12
Please read these instructions for use carefully and keep them
for later use, be sure to make them accessible to other users
and observe the information they contain.
1. Getting to know your device
The wrist blood pressure monitor is used to carry out non-
invasive measurement and monitoring of arterial blood pressure
values in human adults. This allows you to quickly and easily
measure your blood pressure and to display the last recorded
measurement.
A warning is issued for anyone suffering from cardiac ar-
rhythmia.
The recorded values are classified and evaluated graphically.
2. Important notes
Signs and symbols
The following symbols are used in these instructions for use,
on the packaging and on the type plate for the device and the
accessories:
Attention
Note
Note on important information
Observe the instructions for use
Application part, type BF
Direct current
Dispose of the device in accordance with EC
Directive – WEEE (Waste Electrical and Elec-
tronic Equipment).
Manufacturer
Storage
RH 10-95%
-20°C
60°C
Permissible storage temperature and
humidity
ENGLISH
1. Getting to know your device .......................................... 12
2. Important notes .............................................................. 12
3. Unit description .............................................................. 15
4. Preparing the measurement ...........................................16
5. Measuring blood pressure ............................................. 17
6. Saving and displaying measurements ...........................19
7. Deleting stored values ....................................................19
8. Error message/troubleshooting ...................................... 19
9. Cleaning and storing the device and cuff .......................19
10. Technical specifications ............................................... 19
Contents
13
Operating
10°C
40°C
RH 30-85%
Permissible operating temperature and
humidity
Protect from moisture
SN Serial number
0483
The CE labelling certifies that the product
complies with the essential requirements of
Directive 93/42/EEC on medical products.
Advice on use
•
In order to ensure comparable values, always measure your
blood pressure at the same time of day.
•
Before every measurement, relax for about five minutes.
•
If you want to perform several measurements on the same
person, wait five minutes between each measurement.
•
Do not take a measurement within 30 minutes after eating,
drinking, smoking or exercising.
•
Repeat the measurement if you are unsure of the measured
value.
•
The measurements taken by you are for your information
only – they are not a substitute for a medical examination!
Discuss the measurements with your doctor, and never base
any medical decisions on them (e.g. medicines and their ad-
ministration)!
•
Do not use the blood pressure monitor on newborns, preg-
nant women or patients with preeclampsia.
•
In the case of restricted circulation on the arm as a result of
chronic or acute vascular diseases (including vascular con-
striction), the accuracy of the wrist measurement is limited.
In this case you should avoid using an upper arm blood pres-
sure monitor.
•
This device is not intended for use by people (including chil-
dren) with restricted physical, sensory or mental skills or a
lack of experience and/or a lack of knowledge, unless they
are supervised by a person who has responsibility for their
safety or they receive instructions from this person on how
to use the device. Supervise children around the device to
ensure they do not play with it.
•
Cardiovascular diseases may lead to incorrect measurements
or have a detrimental effect on measurement accuracy. The
same also applies to very low blood pressure, diabetes, circu-
latory disorders and arrhythmias as well as chills or shaking.
•
The blood pressure monitor must not be used in connection
with a high-frequency surgical unit.
•
Only use the unit on people who have the specified wrist
measurement for the device.
•
Please note that when inflating, the functions of the limb in
question may be impaired.
•
During the blood pressure measurement, blood circulation
must not be stopped for an unnecessarily long time. If the
device malfunctions, remove the cuff from the arm.
•
Do not allow sustained pressure in the cuff or frequent meas-
urements. The resulting restriction of the blood flow may
cause injury.
•
Ensure that the cuff is not placed on an arm in which the
arteries or veins are undergoing medical treatment, e.g. in-
travascular access or therapy, or an arteriovenous (AV) shunt.
14
•
Do not use the cuff on people who have undergone a mas-
tectomy.
•
Do not place the cuff over wounds as this may cause further
injury.
•
Place the cu on your wrist only. Do not place the cu on
other parts of the body.
•
The blood pressure monitor can only be operated with batteries.
•
To conserve the batteries, the monitor switches off automati-
cally if no buttons are pressed for two minutes.
•
The device is only intended for the purpose described in
these instructions for use. The manufacturer is not liable for
damage resulting from improper or careless use.
Instructions for storage and maintenance
•
The blood pressure monitor is made from precision and elec-
tronic components. The accuracy of the measurements and
service life of the device depend on its careful handling:
– Protect the device from impacts, humidity, dirt, marked
temperature fluctuations and direct sunlight.
– Do not drop the device.
– Do not use the device in the vicinity of strong electromag-
netic fields and keep it away from radio systems or mobile
telephones.
•
Do not press the buttons before the cuff is placed on the arm.
•
We recommend that the batteries be removed if the device
will not be used for a prolonged period of time.
Notes on handling batteries
•
If your skin or eyes come into contact with battery fluid, flush
out the affected areas with water and seek medical assistance.
•
Choking hazard! Small children may swallow and
choke on batteries. Store the batteries out of the reach of
small children.
•
Observe the plus (+) and minus (-) polarity signs.
•
If a battery has leaked, put on protective gloves and clean
the battery compartment with a dry cloth.
•
Protect the batteries from excessive heat.
•
Risk of explosion! Never throw batteries into a fire.
•
Do not charge or short-circuit batteries.
•
If the device is not to be used for a long period, take the
batteries out of the battery compartment.
•
Use identical or equivalent battery types only.
•
Always replace all batteries at the same time.
•
Do not use rechargeable batteries.
•
Do not disassemble, split or crush the batteries.
Instructions for repairs and disposal
•
Batteries do not belong in household waste. Please dispose
of empty batteries at the collection points intended for this
purpose.
•
Do not open the device. Failure to comply will result in voiding
of the warranty.
•
Do not repair or adjust the device. Proper operation can no
longer be guaranteed in this case.
•
Repairs must only be carried out by Customer Services or
authorised suppliers. Before making a claim, please check
the batteries first and replace them if necessary.
•
For environmental reasons, do not dispose of the device in
the household waste at the end of its useful life. Dispose of
15
the device at a suitable local collection or recycling
point. Dispose of the device in accordance with EC
Directive – WEEE (Waste Electrical and Electronic
Equipment). If you have any questions, please contact the
local authorities responsible for waste disposal.
3. Unit description
1. Display
2. Scale for classifying the measurements
3. Wrist cuff
4.
START/STOP button
5. User selection button
6. Memory button +/M
7. Date/time setting button
8. Battery compartment lid
Information on the display:
1. Time and date
2. Systolic pressure
3. Classification of measurements
4. Diastolic pressure
5. Cardiac arrhythmia symbol
6. Calculated pulse value
7. Pulse symbol
8. Pump up, release air (arrow)
9. User memory /
10. Unit in mmHg
11. Average value of the last three measurements
12. Battery level indicator
13. Memory space number
8
1
2
3
4567
11
12
13
10
9
8
6 57 4
1 2
3
16
4. Preparing the measurement
Insert the batteries
•
Remove the battery
compartment lid on the
left side of the device.
•
Insert two 1.5 V micro
(alkaline type LR03) bat-
teries.
Make sure that the batteries are inserted the correct way
round. Do not use rechargeable batteries.
•
Close the battery compartment lid again carefully.
If the battery change symbol is flashing and appears,
no more measurements are possible and you must replace
all batteries.
After inserting the batteries, the year appears on the display
and you can then set the date and time.
Battery disposal
• The empty, completely flat batteries must be disposed of
through specially designated collection boxes, recycling
points or electronics retailers. You are legally required to
dispose of the batteries.
• The codes below are printed on batteries
containing harmful substances:
Pb = Battery contains lead,
Cd = Battery contains cadmium,
Hg = Battery contains mercury.
Setting the date and time
You should set the date and time without fail. Otherwise, you
will not be able to save your measured values correctly with
a date and time and access them again later. The time is dis-
played in the 24-hour format.
To set the date and time, proceed as follows:
1. After inserting the batteries:
•
Following the display check, during which all segments ap-
pear, the year flashes on the display.
•
Using the +/M button, you can increase the basic values to be
set. Set the year and confirm the entry using the button.
•
Now set the month using the +/M button. Confirm using the
button.
•
Set the day/hour/minute and confirm each using the
button.
•
To switch off, press the START/STOP button .
2. At any time:
•
Press the button to display the date/time and current user
memory.
•
Press and hold the button again for about 3 seconds to
reach Date and time mode.
•
Set as described above.
17
5. Measuring blood pressure
Attach the cuff
•
Expose your left wrist. Ensure that the circulation of the arm
is not hindered by tight clothing or similar.
Place the cuff on the inside of your wrist.
•
Fasten the cuff with the hook and loop fastener so that the
upper edge of the monitor is positioned approx. 1 cm below
the ball of your thumb.
•
The cuff must be fitted tightly around the wrist, but must not
constrict.
Adopt the correct posture
•
Before every measurement, relax for about five minutes.
Otherwise deviations can occur.
•
You can perform the measurement while
sitting or lying. To carry out a blood
pressure measurement, make sure you
are sitting comfortably with your arms
and back leaning on something. Do not
cross your legs. Place your feet flat on
the ground. Make sure to rest your arm
and move it. Always make sure that the cuff is at heart level.
Otherwise significant deviations can occur. Relax your arm
and the palm of your hand.
•
To avoid falsifying the measurement, it is important to remain
still during the measurement and not to speak!
Selecting memory
Press the button to display the date/time and current user
memory. Select the desired user memory by pressing the user
selection button . Confirm your selection with the button.
You have 2 memories with 60 memory spaces each to store the
measurements of 2 different people separately or to separate
measurements taken in the morning and at night.
Performing the blood pressure measurement
•
As described above, attach the cuff and adopt the posture
in which you want to perform the measurement.
•
Select the user memory or . Start the measurement by
holding the button. Following the display check, during
which all numbers appear, the cuff inflates automatically.
Whilst the cuff is pumping up, the device already calculates
measurements for estimating the necessary pump pressure.
If this pressure is insufficient, the device automatically pumps
more pressure.
•
Then the pressure in the cuff is slowly released and the pulse
is detected.
•
When the measurement has been taken, the remaining air
pressure dissipates very quickly. The pulse, the systolic and
diastolic blood pressure are displayed.
•
Measuring can be cancelled at any time by pressing .
•
The symbol
_
appears if the measurement could not be per-
formed properly. Take note of the chapter on error messages/
18
trouble-shooting in these instructions for use and repeat the
measurement.
•
The device switches off automatically after 2 minutes.
Wait at least 5 minutes before taking another measurement!
Evaluating results
Cardiac arrhythmias:
This unit can identify potential disruption of the heart rhythm
when measuring and if necessary, indicates this after the meas-
urement with the symbol .
This can be an indicator for arrhythmia. Arrhythmia is an illness
in which the heart rhythm is abnormal because of flaws in the
bioelectrical system that regulates the heartbeat. The symptoms
(skipped or premature heart beats, pulse being slow or too fast)
can be caused by factors such as heart disease, age, physical
make-up, excess stimulants, stress or lack of sleep. Arrhythmia
can only be determined through an examination by your doctor.
If the symbol is shown on the display after the measure-
ment has been taken, it should be repeated. Please ensure that
you rest for 5 minutes beforehand and do not speak or move
during the measurement. If the symbol appears frequently,
please consult your doctor. Self-diagnosis and treatment based
on the measurements can be dangerous. Always follow your
GP’s instructions.
Classification of measurements:
The measurements can be classified and evaluated in ac-
cordance with the following table.
However, these standard values serve only as a general
guideline, as the individual blood pressure varies in different
people and different age groups etc.
It is important to consult your doctor regularly for advice.
Your doctor will tell you your individual values for normal
blood pressure as well as the value above which your blood
pressure is classified as dangerous.
The classification on the display and the scale on the unit
show which category the recorded blood pressure values fall
into. If the values of systole and diastole fall into two different
categories (e.g. systole in the ‚High normal‘ category and
diastole in the ‚Normal‘ category), the graphical classifica-
tion on the device always shows the higher category; for the
example given this would be ‚High normal‘.
Blood pressure
value category
Systole
(in mmHg)
Diastole
(in mmHg) Action
Setting 3:
severe hyper-
tension
≥ 180 ≥ 110 seek medical at-
tention
Setting 2:
moderate hyper-
tension
160 – 179 100 – 109 seek medical at-
tention
Setting 1:
mild hyperten-
sion
140 – 159 90 – 99 regular monitoring
by doctor
High normal 130 – 139 85 – 89 regular monitoring
by doctor
Normal 120 – 129 80 – 84 self-monitoring
Optimal < 120 < 80 self-monitoring
Source: WHO, 1999 (World Health Organization)
19
6. Saving and displaying measurements
•
The results of every successful measurement are stored
together with the date and time. If there are more than 60
measurements, the oldest measurements are lost.
•
Use the button and then the button to select the desired
user memory. Pressing the +/M button displays the average
value of the 3 most recent measurements stored in the user
memory.
If you continue to press the memory button +/M,
the most recent individual measured values are displayed in
turn with the date and time.
7. Deleting stored values
To delete individual measurements, you must first select them.
Press and hold the memory button +/M until appears in the
display. Then confirm the deletion with the user selection button
( and appear on the display).
To delete measurements from a user memory, you must first
select them. Press the memory button +/M and the average
value of the last 3 saved measurements is displayed. Then press
and hold the memory button +/M again until appears in the
display. Confirm the deletion with the user selection button
( and appear on the display).
8. Error message/troubleshooting
In the event of errors, the error message
_
appears on the
display.
Error messages may appear if:
•
it was not possible to record the pulse: ;
•
you move or speak during the measurement: ;
•
the cuff is fastened too tightly or loosely: ;
•
errors occur during the measurement: ;
•
the pump pressure is higher than 300mmHg: ;
•
the batteries are almost empty .
In such cases, repeat the measurement. Ensure that you do not
move or speak. If necessary, reinsert or replace the batteries.
9. Cleaning and storing the device and cuff
•
Clean the device and cu carefully using a slightly damp
cloth only.
•
Do not use any cleaning agents or solvents.
•
Under no circumstances hold the device and cu under
water, as this can cause liquid to enter and damage the
device and cu.
•
If you store the device and cu, do not place heavy objects
on the device and cu. Remove the batteries.
10. Technical specifications
Model no. SBC 21
Measurement
method
Oscillometric, non-invasive blood pres-
sure measurement on the wrist
Measurement
range
Cuff pressure 0-300 mmHg,
systolic 50-250 mmHg,
diastolic 30-200 mmHg,
pulse 40-180 beats /minute
Display accuracy Systolic ± 3 mmHg, diastolic ± 3 mmHg,
pulse ± 5 % of the value shown
Measurement
inaccuracy
Max. permissible standard deviation
according to clinical testing:
systolic 8 mmHg / diastolic 8 mmHg
20
Memory 2 x 60 memory spaces
Dimensions L 70 mm x W 72 mm x H 27.5 mm
Weight Approximately 105 g (without batteries)
Cuff size
135 to 195 mm
Permissible operat-
ing conditions
+10 °C to +40 °C, 30-85 % relative hu-
midity (non-condensing)
Permissible storage
conditions
-20 °C to +60 °C, 10-95 % relative hu-
midity, 700-1050 hPa ambient pressure
Power supply 2 x 1.5 V AAA batteries
Battery life For approx. 300 measurements,
depending on levels of blood pressure
and pump pressure
Accessories Instructions for use, 2 x 1.5 V AAA bat-
teries, storage box
Classification Internal supply, IPX0, no AP or APG,
continuous operation, application part
type BF
• This unit is in line with European Standard EN 60601-1-2 and
is subject to particular precautions with regard to electro-
magnetic compatibility (EMC). Please note that portable and
mobile HF communication systems may interfere with this
unit. More details can be requested from the stated Customer
Services address or found at the end of the instructions for
use.
• This device is in line with the EU Medical Devices Directive
93/42/EEC, the “Medizinproduktegesetz” (German Medi-
cal Devices Act) and the standards EN1060-1 (non-inva-
sive sphygmomanometers, Part 1: General requirements),
EN1060-3 (non-invasive sphygmomanometers, Part3: Sup-
plementary requirements for electro-mechanical blood pres-
sure measuring systems) and IEC80601-2-30 (Medical elec-
trical equipment – Part 2-30: Particular requirements for the
safety and essential performance of automated non-invasive
blood pressure monitors).
• The accuracy of this blood pressure monitor has been care-
fully checked and developed with regard to a long useful life.
If using the device for commercial medical purposes, it must
be regularly tested for accuracy by appropriate means. Pre-
cise instructions for checking accuracy may be requested
from the service address.
Subject to error and change

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