User's Manual

Supplier’s Declaration
The Quanta Smart Wearable ECG Monitoring Device conforms to the international EN 60601-1 and EN
60601-1-2 standards for electromagnetic compatibility with medical electrical devices and systems.
Emission Testing Compliant Standard Electromagnetic Environment Guidelines
The recommended electromagnetic environment for this instrument is shown in the table below. The
customer or user should ensure that this instrument is used in the described environment.
RF Emissions
CISPR 11
Group 1
Radio-frequency is only used by the internal functions of
this instrument. The emission energy is also very low
and does not interfere with nearby electronic
instruments.
RF Emissions
CISPR 11
Class B
This instrument is suitable for home use (including
residential or other mixed residential/public low-voltage
power grids)
Harmonic Emissions IEC 61000-3-2
Voltage
Fluctuations/
Flicker Emissions
IEC 61000-3-3
Testing IEC 60601-1-2 testing
Compliant
Standard
Electromagnetic Environment
Guidelines
The recommended electromagnetic environment for this instrument is shown in the table below. The
customer or user should ensure that it is used in the described environment.
Electrostatic
Discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
The floor should be timber,
concrete or ceramic tile. If the
floor is covered in a synthetic
material then it should have a
relative humidity of at least
30%.
Power Frequency
(50/60Hz)
Magnetic Field
IEC 61000-4-8
3 A/m 3 A/m Power frequency and magnetic
field in representative
commercial or hospital
environments.
Supplier's declaration and guidelines — Electromagnetic Immunity
Testing IEC 60601-1-2 testing
Compliant
Standard
Electromagnetic Environment Guidelines
The recommended electromagnetic environment for this instrument is shown in the table below. The
customer or user should ensure that it is used in the described environment.