Volcano CORE Mobile, Руководство оператора

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intensity levels, “white out” the IVUS image. Under this extreme condition the
IVUS system is rendered in-operable. Whenever electromagnetic interference
renders the IVUS system inoperable, the appropriate action is to identify the
source of the interfering signal and reduce the in-band local intensity levels
sufficient to operate the IVUS system.

CAUTION: This device is not intended for use in the presence of flammable
substances which could cause combustion.

CAUTION: The Volcano system should not be used adjacent to or stacked with
other equipment and if adjacent or stacked use is necessary, the system should be
observed to verify normal operation in the configuration in which it will be used.

WARNING: Portable and mobile RF communications equipment can affect
MEDICAL ELECTRICAL EQUIPMENT
. See Chapter 18, Technical Specifications
for the recommended separation distances between portable and mobile RF
communications equipment and the Volcano Model equipment.

WARNING: The use of accessories, transducers and cables other than those
specified, with the exception of transducers and cables sold by the manufacturer
of the system as replacement parts for internal components, may result in
increased emissions or decreased immunity of the system.

WARNING: Accessory equipment connected to the analog and digital
interfaces must be certified according to the respective IEC standards (i.e. IEC
60950 for data processing equipment and IEC 60601-1:2005 for medical
equipment). Furthermore all configurations shall comply with the system
standard IEC 60601-1, Clause 16. Anyone who connects additional equipment
to the signal input part or signal output part configures a medical system, and is
therefore responsible that the system complies with the requirements of IEC
60601-1-1:2000. If in doubt, consult the technical services department or your
local representative. In specific, AC Mains powered devices are not
recommended unless approved and installed by Volcano Corporation.

WARNING: Changes to IT-networks including network configuration updates,
equipment disconnection, equipment update or upgrade, or additional equipment
connection to IT-networks could result in previously unidentified risks to
patients, operators, or third parties.

CAUTION: Non-medical equipment supplied as part of the Volcano Imaging
System is intended to be connected to a multiple socket-outlet isolation
transformer. If any Volcano or customer-supplied equipment is connected
directly to a wall outlet or a multi-socket outlet, this may result in excessive
leakage current per IEC 60601-1 and presents a risk of electric shock to the
operator and/or patient. The user must verify that the leakage current remains
below the IEC 60601-1 limits.

WARNING: Do not connect a multiple socket-outlet or extension cord to the
system. This may exceed the safety limits of the system and void the warranty.

WARNING:
The Volcano system contains no user-serviceable components. To
avoid electric shock, do not remove any panels or covers. In the event of
malfunction or system damage, turn the system off, unplug the system from the
power receptacle, and contact a qualified service person and Volcano Customer
Service.