Use Instructions

SpiroSphere
®
ECG Instructions for Use
Page 125/136
Version 02.02 • 04AUG2022
Guidance and Manufacturer¶s Declaration ± Electromagnetic Emissions
The ECG unit is intended for use in the electromagnetic environment specied below. The customer or
the user of the ECG unit should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment ± Guidance
RF Emissions CISPR 11 Group 1 The ECG unit uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.
RF Emissions CISPR 11 Class B The ECG unit is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
Guidance and Manufacturer¶s Declaration ± Electromagnetic Immunity
The ECG unit is intended for use in the electromagnetic environment specied below. The customer or
the user of the ECG unit should assure that it is used in such an environment.
Immunity Test IEC 60601 Test
Level
Compliance Level Electromagnetic Environment
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4kV, ±8kV air
±8 kV contact
±2 kV, ±4kV, ±8kV air
Floors should be wood, concrete
or ceramic tile. If oors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Radiated,
Radiofrequency,
Electromagnetic
Field Immunity
IEC 61000-4-3
3 V/m
80 to 2700 MHz
80% AM at 1 kHz
3 V/m
80 to 2700 MHz
80% AM at 1 kHz
Portable and mobile RF
communications equipment must
be used no closer to any part of
the ECG unit, including cables,
than the recommend separation
distance shown earlier
Power Frequency
Magnetic Field
IEC 61000-4-8
30 A/m
(50/60Hz)
30 A/m
(50/60Hz)
Power frequency magnetic elds
should be at levels characteristic
of a typical commercial or
hospital environment.
ECG ampli¿er