Table 18. Environment Compliance
Environment Compliance Butterfly iQ Butterfly iQ+ Butterfly iQ3
IEC 60601-1-11, Home Use - ✓ ✓
IEC 60601-1-12, EMS
Environment
- ✓ ✓
18.5. Electromagnetic Conformance (EMC)
The Butterfly iQ/ iQ+/ iQ3 is intended to enable diagnostic ultrasound imaging and measurement of anatomical
structures and fluids by qualified and trained healthcare professionals. Electromagnetic fields, however, can cause
distortion or degradation of this information, affecting this performance.
The Butterfly iQ/ iQ+/ iQ3 has been designed for use within electromagnetic environments specified in Table 19,
“Electromagnetic Emissions” [95] and Table 20, “Electromagnetic Immunity” [96]. To avoid radiated and conducted
electromagnetic disturbances, the customer or the user of the Butterfly iQ/ iQ+/ iQ3 should assure that it is used
within these stated specifications.
Table 19. Electromagnetic Emissions
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
Emission Test
Compliance
Butterfly iQ
Butterfly iQ+ Butterfly iQ3
RF emission CISPR 11
EN55011
Group 1
a.
RF emission CISPR 11
EN55011
Class A
b.
Class B
c.
Harmonic emission EN/IEC
61000-3-2
Not applicable
Voltage fluctuations/flicker
emissions EN/IEC 6100-3-3
Not applicable
a.
The Butterfly iQ/ iQ+/ iQ3 Ultrasound System 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.
b.
The Butterfly iQ Ultrasound System is suitable for use in all establishments, excluding domestic establishments and those directly connected to
the public low-voltage power supply network that supplies buildings used for domestic purposes.
c.
The Butterfly iQ+/ iQ3 Ultrasound System 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.
Electromagnetic Conformance (EMC)
Specifications 95
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