CAUTIONS!
• Cardiac rhythm disturbances during cardiac studies using gas ultrasound contrast agents have
been observed in the diagnostic range of Mechanical Index (MI) values. See the specific
package insert for the contrast agent being used for further details.
• Butterfly Cloud enables remote viewing of ultrasound images on a variety of platforms and in
uncontrolled environments (e.g., ambient lighting). Clinician discretion on the appropriate use of
images must be applied.
• Only trained operators should use the instrument for needle placement.
• Special precautions should be considered when using the transducer on children or other
patients who may have pre-existing conditions or sensitivity to temperature.
NOTES
The Butterfly iQ/ iQ+/ iQ3 has been designed to ensure that acoustic limits are not exceeded in
any imaging mode. The Butterfly iQ/ iQ+/ iQ3 has been designed and certified to comply with:
• IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV Medical electrical equipment Part 1: General
requirements for basic safety and essential performance.
• IEC 60601-2-37:2007 Medical electrical equipment - Part 2-37: Particular requirements for
the basic safety and essential performance of ultrasonic medical diagnostic and monitoring
equipment.
Basic Safety/Usage Environment
Safety Information 13
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