Silvercrest HealthForYou SBM68 Instructions For Use And Safety Notes

UPPER ARM BLOOD PRESSURE MONITOR
IAN 290990
OBERARM-BLUTDRUCKMESSGERÄT Gebrauchsanleitung und Sicherheitshinweise
BLODTR YKSMÅLER TIL OVERARMEN
Brugsvejledning og sikkerhedshenvisninger
UPPER ARM BLOOD PRESSURE MONITOR
Instructions for Use and Safety Notes
GB / IE / NI Instructions for Use and Safety Notes Page 5 DK Brugsvejledning og sikkerhedshenvisninger Side 43 DE / AT / CH Gebrauchsanleitung und Sicherheitshinweise Seite 79
Before reading, unfold both pages containing illustrations and familiarise yourself with all functions of the device.
Før du læser, vend begge sidene med billeder frem og bliv bekendt med alle apparatets funktioner.
Klappen Sie vor dem Lesen die beiden Seiten mit den Abbildungen aus und machen Sie sich anschlie­ßend mit allen Funktionen des Gerätes vertraut.
C D
A
1
7
2 3 4
5 6
8
9
10
11
B
12
13
14
151617
18
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22
E F
G H
I J
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List of pictograms used ...............................................Page 6
Introduction .....................................................................Page 7
Intended Use .................................................................... Page 8
Improper Use ...................................................................Page 8
Parts Description ..............................................................Page 9
Scope of delivery .............................................................Page 10
Technical Data ................................................................. Page 10
Important Safety Notes ..............................................Page 13
Battery safety information ...............................................Page 15
Initial use ........................................................................... Page 17
App / web version of „HealthForYou“ ...........................Page 18
Configuring the date / time / bluetooth
®
........................Page 18
Measuring blood pressure ........................................Page 19
Attaching the cuff ............................................................. Page 20
Adopting the correct posture ..........................................Page 20
Selecting a memory ......................................................... Page 21
Carrying out the blood pressure measurement .............Page 21
Transferring measurements via Bluetooth
®
.......Page 23
Evaluating Measurements ......................................... Page 24
Classification of measurement results ............................. Page 25
Saving, requesting and deleting
measurements ................................................................Page 26
Cleaning and Care.........................................................Page 28
Storage ..............................................................................Page 28
Troubleshooting ............................................................. Page 29
Disposal .............................................................................Page 30
Warranty / Service ........................................................Page 31
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List of pictograms used
Warning of risks of injury or health hazards
Safety note related to possible damage to the device / components
Safety notes
Instructions
Observe instructions for use
Direct current
Storage & Transport
Permissable storage and transport temperature and humidity
Operating
Permissible operating temperature and humidity
Permissible storage, transport and operating air pressure
Manufacturer
7 GB/IE/NI
Applied part, type BF
Serial number
0483
The CE mark certifies compliance with the basic requirements of Medical Devices Directive 93/42/EEC.
Improper disposal of batteries can harm the environment!
IP21
Device protected against foreign matter ≥12.5 mm and against water falling vertically
21
PAP
Dispose of the packaging and the blood pressure monitor in an environmentally friendly manner!
Upper arm blood pressure monitor
Introduction
Please make yourself familiar with the upper arm blood pressure monitor before preparing it for
use or using it for the first time. Please carefully read the following instructions for use and the important safety notes. Failure to observe the notes may result in per­sonal injury or property damage. The product must only be
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used as described in these instructions for use and for the specified fields of application. Keep these instructions for use in a safe place. If you pass the upper arm blood pres­sure monitor on to anyone else, please ensure that you also pass on all the documentation.
Intended Use
This upper arm blood pressure monitor is intended to meas­ure and monitor the arterial blood pressure values of adults in a non-invasive way. Using this device, you can quickly and easily measure your blood pressure, save the measurements and display the progression and average of these measurements. You are warned in cases of pre-existing cardiac arrhythmia. The values determined are classified and evaluated graphically. Any use other than previously mentioned or any product modification is prohibited and may result in injuries and / or product damage. The manufacturer assumes no liability for damage arising out of improper use. The product is only intended for use in private environments (at home).
Improper Use
Do not use this product on newborns and preeclampsia patients. We recommend consulting your doctor before using the product if you are pregnant.
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The measurements determined by you are only intended
for your information - they do not replace a medical ex­amination. Discuss the measurements with your doctor. Do not self-diagnose or self-treat based on the measure­ment results without consulting your attending physician. Do not start new medication without consulting a doctor and do not modify the type and / or dosage of current medications.
The product may not be used in conjunction with a
high-frequency surgical unit.
Parts Description
1
Cuff
2
Cuff tubing
3
Cuff plug
4
Display
5
Memory button M
6
Settings button SET
7
Function button -/+
8
START/STOP button
9
Scale for classifying measurement results
10
Connection for cuff plug
11
Battery compartment
Display indicators
12
Time and date
13
Systolic pressure
14
Diastolic pressure
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15
Release air
16
Pulse value determined
17
Classification of measurement results
18
Symbol for cardiac arrhythmia
Symbol pulse
19
Memory display: Average value (A), morning (AM),
evening (PM), number of the memory space
20
Symbol for replace battery
21
User memory
22
Symbol for Bluetooth® transfer
Scope of delivery
1 Upper arm blood pressure monitor 1 Upper arm cuff (Material no. 163.243) with cuff tubing 4 Batteries 1.5 V Type AA 1 Instructions for use 1 Quick start guide
Technical Data
Model no.: SBM 68 Measuring method Oscillometric, non-invasive blood
pressure measurement on the upper arm
Measurement range: Cuff pressure 0–300 mmHg,
systolic 50–250 mmHg, diastolic 30–200 mmHg, pulse 40–180 beats per minute
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Display accuracy: systolic ± 3 mmHg, diastolic
± 3 mmHg, pulse ± 5 % of the
displayed value Measurement uncertainty: max. permissible standard deviation
according to clinical testing: systolic
8 mmHg / diastolic 8 mmHg Memory: 4 x 30 memory spaces Dimensions: L 131 mm x W 107 mm x H 56 mm Cuff: suitable for an arm circumference
between 22 and 36 cm Weight: approx. 282 g (without batteries
and cuff) Permissible operating conditions: +5 °C to +40 °C, 15 to 93% rela-
tive humidity (non-condensing) Permissible storage conditions: -25 °C to +70 °C, < 93% relative
humidity, 700-1060 hPa ambient
pressure Power supply: 4 x 1.5 V AA batteries Product expected lifespan: 5 years Battery life: Approx. 200 measurements, depend-
ing on blood pressure level and infla-
tion pressure / Bluetooth
®
transfer
Components: Instructions for use, 4 x 1.5 V AA,
batteries, storage pouch
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Classification: Internal supply, IP21, no AP or APG,
continuous operation, applied part
Type BF Data transfer via
Bluetooth
®
wireless technology: The product uses Bluetooth
®
low
energy technology, frequency band
2.402 - 2.480 GHz, maximum trans-
mission power radiated in the fre-
quency band < 4 dBm, compatible
with Bluetooth
®
4.0 smart phones /
tablets
For a list of compatible smart phones,
information about the HealthForYou
app and software, as well as further
details about the devices, please
visit: www.healthforyou.lidl
System requirements of the „HealthForYou“ web version - MS Internet Explorer
- MS Edge
- Mozilla Firefox
- Google Chrome
- Apple Safari
(in the respective updated version)
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System requirements of the „HealthForYou“ app iOS from Version 9.0, Android
TM
from Version 5.0, Bluetooth
®
4.0. Technical specifications subject to change without notice due to updates.
Important Safety Notes
This device is not intended to be used by persons with limited physical, sensory or mental abilities or lacking experience and / or knowledge unless supervised or instructed on its use by an person responsible for their safety. Children should be supervised to ensure they do not play with the device.
Cardiovascular system diseases may result in incorrect
measurements and/or impairments to the device‘s measurement accuracy. This is also the case when it comes to low blood pressure, diabetes, circulatory prob­lems and dysrhythmia, as well as chills and shaking.
Only use the product on individuals who have the up-
per arm range stated for the product.
Ensure that the limb is not functionally impaired during
inflation.
Blood circulation should not be restricted by the blood
pressure measurement for an unnecessary amount of time. Remove the cuff from the arm if the device mal­functions.
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Avoid mechanically restricting, compressing or kinking
the cuff tubing.
Avoid sustained pressure to the cuff, as well as frequent
measurements. The resulting curtailing of the blood flow can lead to injuries.
Ensure that the cuff is not placed on an arm whose
arteries or veins are undergoing medical treatment, i.e. intravascular access or intravascular therapy or an arteriovenous (A-V) shunt.
Do not place the cuff on individuals who have had a
mastectomy.
Do not place the cuff over wounds as this could lead to
further injuries.
Only place the cuff on the upper arm. Do not place the
cuff on other body parts.
Attention: The device may only be used in conjunction
with the original cuff provided. Do not use rechargeable batteries. If no button is pressed, the automatic shutoff will switch
off the blood pressure monitor within 1 minute to save
the batteries.
Attention! Potential damage to the device!
The blood pressure monitor is made up of
precision components and electronic compo-
nents. The accuracy of the measurements
and the service life of the device depend on
the device being used with a due amount of
care:
Protect the device from impacts, moisture, dirt, severe
temperature fluctuations and direct sunlight.
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Do not drop the device. Do not use the device in the vicinity of strong electro-
magnetic fields, keep it away from radio equipment
and mobile telephones. Only use the cuff provided or an original replacement
cuff. Otherwise, measurements could be miscalculated. Remove the batteries from the device if it is not used
over a longer period of time. Routinely inspect the device to ensure the device is not
visibly damaged before use and the battery level is suf-
ficient. When in doubt, do not use and contact service
or an authorised retailer. Do not use additional parts
not recommended or sold as components by the manu-
facturer. Never open or repair the device or proper function cannot
be guaranteed. Non-compliance will void the warranty. Please contact service or an authorised retailer for
repairs. However, before making a complaint, firstly
check the batteries and replace them if necessary.
Battery safety
information
DANGER TO LIFE! Keep batteries out of the reach of
children. Seek immediate medical attention if swallowed!
EXPLOSION HAZARD! Never recharge
disposable batteries. Never short-circuit and / or open batteries. The battery may overheat,
ignite or explode. Never throw batteries into fire or water.
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Do not exert mechanical stress on batteries.
Risk of battery leakage
Avoid extreme conditions and temperatures which may
affect batteries, e.g. radiators / direct sunlight.
Avoid contact with the skin, eyes and mucous membranes!
In the event of contact with battery acid, flush the
affected area with clean water and seek immediate
medical attention!
WEAR PROTECTIVE GLOVES! Leaked or
damaged batteries can cause burns on con­tact with the skin. Therefore wear suitable
safety gloves in this case.
In the event of a battery leak, immediately remove the
batteries from the product to prevent damage.
Only use the same type of batteries. Do not mix old
and new batteries!
Remove the batteries if the product will not be used for
an extended period.
Risk of product damage
Only use the specified battery type!
Insert the batteries according to the polarity marking
(+) and (-) on the battery and the product. Clean the contacts on the battery and inside the battery
compartment with a dry cloth before inserting the battery! Immediately remove drained batteries from the product. Do not use rechargeable batteries.
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Initial use
Verify the parts listed in the scope of delivery are com-
plete.
Remove all packaging material.
Inserting / Replacing Batteries
Slide the battery cover off the battery compartment
11
(Fig. C). Insert the four type 1.5V AA (Alkaline Type LR6) batter-
ies (with the correct polarity) into the device (Fig. C).
Please note the marking inside the battery compartment. Carefully close the battery cover on the battery com-
partment
11
.
Do not use rechargeable batteries.
Note: If the battery indicator
20
is displayed continu­ously, measurement is not possible and you must replace all of the batteries with new batteries. As soon as the batteries have been removed from the device, the date and time will be reset.
All display elements will be displayed briefly and „24h“
will flash on the display. Configure the date, time and
Bluetooth
®
(see „Configuring date / time / Bluetooth®“).
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App / web version of
„HealthForYou“
Download the free app „HealthForYou“ from the Apple App Store and Google Play.
Follow the installation instructions on the screen. Alternatively, you can also visit the website
www.healthforyou.lidl. Here you will be able to enter measurements and find guidance for assessment.
Configuring the date /
time / bluetooth
®
Configure the date, hour format and time. It is only in
this way that you will be able to correctly save these measurements with the date and time and request them later on.
Configure the date, Bluetooth
®
and time as follows:
Insert the batteries, or press the SET button
6
for over
5 seconds for batteries that have already been inserted.
Configure the 12-hour or 24-hour mode using the +
7
button. Press the SET button
6
to confirm.
The year will flash.
Configure the year using the + button. Press the SET
button
6
to confirm.
The month will flash.
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Configure the month using the + button. Press the SET
button
6
to confirm.
Configure the day, hour and minute consecutively as
described above. Press the SET
6
button to confirm
each entry.
The Bluetooth
®
symbol will be shown on the display.
„On“ or „Off“ will flash at the same time.
Using the function buttons „-/+“ choose whether you
want to activate („On“ flashes) or deactivate („Off flashes“) automatic Bluetooth
®
data transfer. Press the
SET button
6
to confirm.
If Bluetooth
®
is activated („On“) data transfer will begin
automatically after the measurement has been taken.
Note: The battery life is reduced by transfer via
Bluetooth
®
.
Measuring blood pressure
Note: To guarantee that you will be able to compare
values adequately, always measure your blood pressure at the same time of day. Rest for approx. 5 minutes before every measurement!
If you wish to undertake multiple measurements on the
one person, wait for 5 minutes between taking each measurement.
You should not eat, drink, smoke or be active in the
30 minutes before each measurement.
Repeat the measurement process if the measured values
seem incorrect.
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Bring the device to room temperature before the meas-
urement.
Attaching the cuff
ATTENTION! The device may only be used in conjunc-
tion with the original cuff provided. The cuff is suitable for an arm circumference between 22 and 36 cm.
Place the cuff
1
on a bare upper left arm (Fig. D). The blood flow of the arm should not be constricted by clothing which is too tight, etc.
The cuff
1
should be placed on the upper arm in such a way that the lower edge lies 2–3 cm over the crook of the arm and the artery. The cuff tubing
2
points to
the centre of the palm.
Place the free end of the cuff
1
closely, but not too tightly, around the arm and close the Velcro strip. The cuff
1
should not be too tight (Fig. E). Check that two
fingers can still fit beneath the cuff
1
(Fig. F).
Now insert the cuff tubing
2
with the cuff plug
3
into
the connector (Fig. G).
Adopting the correct posture
Note: Stay still during the measurement process and do not
talk to prevent the measurement result from being falsified.
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You can carry out the measurement while sitting or lying
down. Always ensure that the cuff
1
is at the same
level as the heart (Fig. H-J).
Sit comfortably for the blood pressure measurement.
Recline your back and arms. Do not cross your legs. Put your feet flat on the ground.
In order not to falsify the measurement result, it is impor-
tant that you stay still and do not talk.
Selecting a memory
Press the SET button
6
. Select the desired user mem-
ory
...
21
by pressing the function buttons -/+
7
.
You have 4 memories with 30 memory spaces for
saving the measurement results of 4 different people separately.
Confirm your choice using the START / STOP button
8
or wait 3 seconds. Your choice will then be saved
automatically.
Carrying out the blood
pressure measurement
Place the cuff on your arm as previously described and
assume the position in which you wish to carry out the measurement.
Switch on the blood pressure monitor using the START /
STOP button
8
.
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After the full-screen display, the last measurement result saved will be displayed. If no measurement has been saved, the de­vice will display the value of „0“. The cuff will inflate automatically. The cuff air pressure is released slowly. If a tendency towards high blood pressure has been detected, it will be repressurised and the cuff pres­sure will be increased once more. As soon as a pulse has been detected, the pulse symbol
will be displayed. The measurement results for systolic pressure, diastolic pres­sure and pulse will be displayed.
You can stop the measurement at any time by pressing
the START / STOP button
8
.
If the measurement has not been carried out correctly,
„Er_“ will be displayed. Also take a look at „Trouble-
shooting“ and repeat the measurement process. The measurement result will be saved automatically. If you have activated Bluetooth
®
data transfer, the data will be transferred. The blood pressure monitor displays the symbol for Bluetooth
®
transfer during transfer. Switch the blood pressure monitor off by pressing the START / STOP button once more.
To power down press the START / STOP button
8
.
Note: The device switches off automatically after one minute if no button has been pressed. Wait for at least 5 minutes before taking another measurement!
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Transferring measurements
via Bluetooth
®
You have the option of transferring the measured values and values saved on your device to your smartphone using
Bluetooth
®
low energy technology.
Activate Bluetooth® in your smartphone settings and
open the „HealthForYou“ app.
Note: The „HealthForYou“ app must be activated for
transfer to occur.
Add „SBM 68“ in the app.
Warning! The displayed values are intended merely as a
visualisation and may not be used as the basis for therapeu­tic measures. The software is not part of a diagnostic medi­cal system. We wish to expressly indicate that the software at hand is not a medical product in accordance with the EU directive 93/42/EEC. Note: During data transfer, button functions cannot be executed. To transfer measurements to your smartphone via Bluetooth
®
proceed as follows:
Manual transfer
Go to save mode (see „Saving, requesting and deleting measurements“). As soon as the average value of all meas­urements is displayed, a Bluetooth
®
connection will auto­matically be established. The data will be transferred and the Bluetooth
®
symbol will be shown on the display.
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Switch the blood pressure monitor off by pressing the
START / STOP button
8
.
Automatic transfer
If you forget to switch off the blood pressure monitor, it will automatically switch off after one minute. In this case, the value will be saved in the selected user memory and the data will be transferred if Bluetooth
®
data transfer has been
activated. The Bluetooth
®
symbol will be shown on the
display during transfer.
Evaluating Measurements
Cardiac arrhythmia
This device can identify any potential cardiac arrhythmia disorders and, if necessary, indicates this after the measure­ment process with the symbol
. This can be an indicator for arrhythmia. Arrhythmia is an illness in which the heart rhythm is abnor­mal due to errors in the bioelectric system, which controls the heartbeat. The symptoms (skipped or premature heart­beats, slow or rapid pulse) can stem from heart conditions, age, physical predispositions, an excess of luxury foods, stress or a lack of sleep. Arrhythmia can only be diagnosed by a doctor after a physical examination.
Repeat the measurement process if the symbol is
shown on the display after the measurement. Please guarantee that you rest 5 minutes before the measure­ment and do not talk or move during it.
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If the symbol is displayed repeat­edly, contact your doctor. Self-diagnosis and self-treatment on the basis of measurement results can be dangerous. Follow your doctor‘s instructions.
Classification of
measurement results
In accordance with the guidelines / definitions provided by the World Health Organisation (WHO) and the latest find­ings, the measurement results can be classified and evalu­ated according to the following table:
Range of blood pressure values
Systole (in mmHg)
Diastole (in mmHg)
Remedies
Stage 3 se­vere hyper­tension
≥ 180 ≥ 110 seek medical
attention
Stage 2: moderate hypertension
160–179 100–109 seek medical
attention
Stage 1: mild hypertension
140–159 90–99 regular monitoring
by a doctor
High, normal 130–139 85–89 regular monitoring
by a doctor
Normal 120–129 80–84 Self-monitor
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Range of blood pressure values
Systole (in mmHg)
Diastole (in mmHg)
Remedies
Ideal < 120 < 80 Self-monitor
Source: WHO, 1999
Note: These standard values merely serve as a general guideline as blood pressure deviates depending on the individual, different age groups, etc.
It is important that you consult your doctor at regular intervals. Your doctor will give you your particular values for normal blood pressure as well as the value for when your blood pressure is classified as dangerous.
The bar chart on the display and the scale on the device state which range the blood pressure measured is in. If the systole and diastole values are in two different ranges (i.e. systole is „high, normal“ and diastole is „normal“) the graphic categorisation on the device will always show the higher range i.e. in the above example this would be „high, normal“.
Saving, requesting and deleting
measurements
The results of each successful measurement are saved together with the date and time. If there are over 30
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measurement values, the oldest measurement value will be overwritten.
Press the SET button
6
. Press the function buttons -/+
7
to select the desired user memory ... . Confirm
your choice using the START / STOP button
8
.
Press the memory button M
5
to display the average value „A“ of all saved measurements pertaining to the user memory. Press the memory button M
5
again to display the average value of the last 7 days for the morning measurement. (Morning: 5.00 am – 9.00 am, display „AM“). Press the memory button M
5
again to display the average value of the last 7 days for the evening measurement. (Evening: 6 pm – 8 pm, display „PM“). By pressing the memory button M again, the last individual measurement will be displayed with the date and time.
Press the START / STOP button
8
to switch off the
device.
Note: The device switches off automatically after one
minute when no button has beenpressed.
Deleting data
Press the memory button M
5
to delete the entire
memory of the respective user.
Wait until the Bluetooth® symbol no longer flashes. Keep
the function buttons -/+
7
pressed simultaneously for 5 seconds.After successful deletion the „CL 00“ will appear in the display.
The data has been deleted.
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Cleaning and Care
ATTENTION! Possible property damage! Never hold
the product under water as liquid could enter the product and damage it.
Clean the device and cuff 1 carefully using a slightly
damp cloth.
Do not use cleaners or solvents.
Storage
Attention! Possible property damage! Do not place
any heavy objects on the device and cuff
1
.
If the product will not be used for more than one month,
remove both batteries from the device to prevent possible battery leakage.
Do not kink the cuff tubing 2. Store the product in a dry location (relative humidity
≤ 93 %). High humidity can shorten the service life or damage the product. Store the product in a location with ambient temperatures between -25 °C and +70 °C.
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Troubleshooting
Trouble­shooting
Problem Solution
Er1 The pulse cannot
be measured correctly.
Repeat the measurement process. Be sure not to move or talk.
Er2 You have been
talking or moving during the meas­urement process.
Er3 The cuff was at-
tached too tightly or too loosely.
Er4 An error occurred
during the meas­urement process.
Er5 The inflation
pressure is over 300 mmHg.
Er6
The batteries are almost dead.
Reinsert the batteries or replace them with new batteries.
Er7
Data cannot be sent via
Bluetooth®.
Activate Bluetooth® on your smartphone and start the "HealthForYou" app.
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Disposal
The packaging is made entirely of recyclable materials, which you may dispose of at local re­cycling facilities.
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PAP
Observe the marking of the packaging materials for waste separation, which are marked with ab­breviations (a) and numbers (b) with following meaning: 1–7: plastics / 20–22: paper and fibreboard / 80–98: composite materials.
In accordance with European Directive (covering waste electrical and electronic equipment) and its transposition into national legislation, worn-out electrical devices must be collected separately and taken for environmentally compatible recy­cling.
Contact your local refuse disposal authority for more details of how to dispose of your worn-out product.
Per Directive 2006 / 66 / EC and its amendments, defective or used batteries must be recycled. Return the batteries and/or the product to a collection site.
Pb Cd Hg
Improper disposal of batteries can harm the environment!
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