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Ultrasound (acoustic) output of the Eagle Eye and PV catheters imaging
transducer is active when an active moving image is displayed
Ultrasound (acoustic) output of the Revolution catheter imaging transducer is
active in imaging mode only
System control of movement of the catheter imaging transducer is limited to the
following operator actions:
− Push and pull motion of the catheter imaging transducer can be initiated
through manual manipulation of catheter body by the operator
− Motorized pullback of the Revolution catheter is manually controlled by
the operator. Motorized push motion of Revolution catheter is not
possible.
Changes in Revolution catheter, ultrasound imaging operation from off to on and
from on to off occur only when initiated by the operator
Ultrasound output power settings are automatically maintained at preset and safe
levels during imaging operations
Electrical safety is maintained in all operational modes
Catheter Acoustic Outputs
Ultrasound Exposure Maxima
Ultrasound Exposure/ Acoustic output power is fixed and cannot be adjusted by the
operator of this equipment. Ultrasound exposure only when LIVE imaging is enabled.
When LIVE imaging is not selected by the operator, no ultrasound exposure occurs.
The Volcano system is in compliance with the Acoustic Output Display Standard and are
within FDA limits for Ultrasound equipment.
Eagle Eye Gold
Acoustic Output Parameter B-Mode ChromaFlo
SPPA
3
3
1. Uncertainty: +33.9% / -30.5%
2. Uncertainty: +17.0% / -15.3%