Guidance And Manufacturer's Declaration - Electromagnetic Immunity - D-Heart 4021 Manual De Instrucciones

Guidance and manufacturer's declaration - electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below. The customer
or the user of the device should assure that it is used in such an environment.
Immunity test
ETSI EN 301 489-1 V1.9.2 (2011-09)
Electromagnetic compatibility and Radio spectrum Matters
(ERM)
Electromagnetic Compatibility (EMC) standard for radio
equipment and services
Part 1: Common technical requirements
ETSI EN 301 489-17 V2.2.1 (2012-09)
Electromagnetic compatibility and Radio spectrum Matters
(ERM)
Electromagnetic Compatibility (EMC) standard for radio
equipment
Part 17: Specific conditions for Broadband Data Transmission
Systems
CEI EN 60601-1-2:2016-04
EN 60601-1-2:2015-09
IEC 60601-1-2:2014-02
Medical electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests
ETSI EN 301 489-1 (V2.2.0)
ElectroMagnetic Compatibility (EMC)
standard for radio equipment and services;
Part 1: Common technical requirements
ETSI EN 301 489-17 (V2.2.1)
ElectroMagnetic Compatibility (EMC)
standard for radio equipment and services;
Part 17: Specific conditions for
Broadband Data Transmission Systems
CEI EN 60601-1-2:2016-04
EN 60601-1-2:2015-09
IEC 60601-1-2:2014-02
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Electrostatic Discharge
12
User Manual Smartphone ECG Device
Compliance level
10 V/m
80 MHz to 2.7 GHz
3 V/m
2.7 GHz to 6.0 GHz
According to IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV
air
D-Heart