iHealth Easy Instrucciones De Uso página 8

This product complies with Industry Canada. IC: RSS-210
IC NOTICE
This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to
the following two conditions:
(1) this device may not cause interference, and
(2) this device must accept any interference, including interference that may cause undesired
operation of the device.
Hereby, [ANDON HEALTH CO., LTD] declares that the radio equipment type [BP3L] is in compliance
with Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet address:
https://ihealthlabs.eu/fr/content/189-DoC-RED
OTHER STANDARDS AND COMPLIANCES
The Wireless Blood Pressure Monitor corresponds to the following standards:
IEC 60601-1:2005/A1:2012/EN 60601-1:2006/A1:2013(Medical electrical equipment – Part 1: General
requirements for safety); IEC 60601-1-2:2014//EN 60601-1-2:2015 (Medical electrical equipment –
Part 1: General requirements for safety; Collateral Standard-Electromagnetic compatibility -
Requirements and tests); EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive
sphygmomanometers - Part 1: General requirements); EN 1060-3: 1997 + A1: 2005 + A2: 2009
(Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical
blood pressure measuring systems);
IEC80601-2-30:2009+AMD1: 2013/EN 80601-2-30:2010/A1: 2015 (Medical electrical equipment –Part
2-30: Particular requirements for the basic safety and essential performance of automated
non-invasive sphygmomanometers).
ISO81060-2 : 2013(Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated
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
Phenomenon
RF emissions
Harmonic distortion
Voltage fluctuations and flicker
Phenomenon
Electrostatic Discharge
Radiated RF EM field
Proximity fields from RF wireless
communications equipment
Rated power frequency magnetic fields
Table 1-Emission
Compliance
CISPR 11 Group 1, Class B
IEC 61000-3-2 Class A
IEC 61000-3-3 Compliance
Table 2 - Enclosure Port
Basic EMC Immunity test levels
standard
Home Healthcare Environment
IEC 61000-4-2 ± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
IEC 61000-4-3
10 V/m
IEC 61000-4-3
Refer to table 3
IEC 61000-4-8
7
Electromagnetic environment
Home healthcare environment
Home healthcare environment
Home healthcare environment
80 MHz to 2.7 GHz
30 A/m 50 Hz or 60 Hz
80% AM at 1 kHz