Classification
Internal supply, IP22, no AP
or APG, continuous operation,
application part type BF
All components
Pump,valve, LCD, cuff, sensor
belonging to the
pressure measuring
system, including
The serial number is located on the device or in the bat-
tery compartment.
Technical information is subject to change without notifi-
cation to allow for updates.
• This device complies with the European standard EN
60601-1 (Medical electrical equipment -- Part 1: Gen-
eral requirements for basic safety and essential per-
formance), EN 60601-1-2 (compliance with CISPR 11,
IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-8) and is
subject to special precautionary measures with regard
to electromagnetic compatibility. Please note that
portable and mobile HF communication systems may
interfere with this device.
• The device complies with the EU Medical Devices
Directive 93/42/EEC, the German Medical Devices Act
(Medizinproduktgesetz) and the standards EN 1060-1
(Non-invasive sphygmomanometers – Part 1: General
requirements), EN 1060-3 (Non-invasive sphygmoma-
nometers – Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring sys-
tems), IEC 81060-2(Non-Invasive Sphygmomanom-
eters - Part 2: Clinical Validation Of Automated Meas-
urement Type) and IEC 80601-2-30 (Medical electrical
equipment – Part 2 – 30: Particular requirements for
the basic safety and essential performance of auto-
mated non-invasive sphygmomanometers).
• The accuracy of this blood pressure monitor has been
carefully checked and developed with regard to a long
useful life. If the device is used for commercial medical
purposes, it must be regularly tested for accuracy by
appropriate means. Precise instructions for checking
accuracy may be requested from the service address.
12. Warranty/service
Medel International, via Villapizzone 26 / 20156, Milan
(hereinafter referred to as "Medel") provides a warranty
for this product, subject to the requirements below and
to the extent described as follows.
The warranty conditions below shall not affect the
seller's statutory warranty obligations which ensue
from the sales agreement with the buyer.
The warranty shall apply without prejudice to any
mandatory statutory provisions on liability.
Medel guarantees the perfect functionality and com-
pleteness of this product.
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