Volcano CORE Mobile - Page 10

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 CAUTION: Although the components are spill-resistant, avoid spilling or
dropping any foreign material onto components. It is important to be especially
careful with the keyboard, controller, CPU and the monitor.
 The bedside-mounted Volcano system equipment complies with the fluid
ingress requirements of IEC60529 (IPX4 for Control Console II and all other
bedside peripherals) when configured for normal use. The bedside-mounted
Volcano equipment should be located under a sterile drape when configured for
normal use.
 WARNING: The Volcano system must be properly grounded to avoid electrical
shock. To avoid risk of electric shock, this equipment must only be connected to
a supply mains with protective earth.
 WARNING: To prevent compromising patient isolation, the Volcano system
console operator must not simultaneously touch the patient and/or any implanted
catheter or guide wire and any part of the Volcano system mobile cart or
computer chassis or connector interface.
NOTE: Within the U.S.A., a hospital-grade receptacle must be used.
 WARNING: Hand crush/pinch potential when positioning device parts.
 CAUTION: The Volcano system must have the original cord, or installed
electrical power in an Volcano integrated system must be used at all times. The
Volcano systems are protected against the voltages of defibrillation; still, we
recommend that you disconnect the catheter from the patient interface module
prior to defibrillation.
 CAUTION: Grounding reliability can only be achieved when equipment is
connected to an equivalent receptacle marked “hospital only” or “hospital grade.”
 CAUTION: Do not obstruct access to the main power cord when plugged into
wall socket.
 CAUTION: Do not connect Volcano equipment to non-medical grade or un-
grounded power strip, especially when shared with non-medical grade
equipment.
 For cardiac catheterization applications, the Volcano system must be connected
to the potential equalization system of the hospital room.
 CAUTION: The Volcano system is a high-gain wide-band patient connected
intravascular ultrasound (IVUS) system intended for use during diagnostic or
interventional percutaneous coronary or peripheral procedures. As such, the
system is susceptible to in-band (5-60MHz) reciprocal interfering
signals. Reciprocal interference is non-synchronous to the IVUS system and
typically transient in nature. When local intensities are sufficiently high, non-
synchronous in-band transient interference will be visible on the IVUS display as
random “speckle” like noise, or faint, intermittent radial spokes or rings. This
type of electromagnetic interference is an annoyance to the operator but typically
does not render the device unusable. Non-transient (modulated continuous wave
transmitters) with in-band center frequency carriers can, under high local