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iHealth Neo Notice D'utilisation page 22

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requirements for basic safety and essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests);
IEC80601-2-30:2009
1
AMD1 : 2013/EN 80601-2-30:2010/A 1 : 201 S(Medical electrical equipment
-Part 2-30: Particular requirements for the basic safety and essential performance of automated
non-invasive sphygmomanometers);
EN 1060-1 • 1995 + A2: 2009 (Non-invasive sphygmomanometers - Part 1 • General requirements),;
EN 1060-3: 1997
+
A2: 2009 (Non-invasive sphygmomanometers - Part 3: Supplementary
requirements for electro-mechanical blood pressure measuring systems);
ISO81060-2 : 2013, (Non-Invasive Sphygmomanometers
Part 2: Clinical Validation Of Automat-
ed Measurement Type).
ELECTROMAGNETIC COMPATIBILITY INFORMATION
This product is applicable to the equipment and system requirements for the purpose of receiving
radio frequency energy for the purpose of the work, Bluetooth receive bandwidth 2M. This product
can also be used to include RF transmitter equipment and system requirements and emission
frequency of 2.4GHz ISM band, Bluetooth modulation types: GFSK, effective radiated power:
< 20dBm.
Table 1 - Emission
Phenomenon
Compiancll
BectromagneClcMM'l1r1111111t
RF emissions
CISPR 11 Group 1, Class B
Home healthcare environment
Harmonic distortion
IEC 61000-3-2 Cla88 A
Home healthcare environment
Voltage fluctuattons and flicker
IFC 61000-3-3 Compliance
Home healthcare environment
Table 2 - Enclosure Port
20

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