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Warnings and Precautions
Read and Review Manual before Operation
Carefully read and review the entire Volcano CORE System Operator’s Manual before
attempting to operate the system.
Volcano Corporation makes no warranty, representation or condition of any kind,
expressed or implied (including any warranty of merchantability, suitability or fitness for
a particular purpose) respecting the misuse of the system or the reuse of the catheter.
Volcano Corporation assumes no responsibility or liability for incidental or consequential
damages which may result from reuse or misuse of the catheter.
WARNINGS are used to indicate the possibility of severe personal injury. Follow
the instruction or procedure correctly to avoid injury to yourself, the patient, or
other personnel.
The warnings are identified by the exclamation symbol.
CAUTIONS are used to indicate the possibility of damage to the equipment. Follow
the instruction or procedure correctly to avoid damage to the equipment.
For Use only by Trained Medical Personnel
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. Only
physicians or other persons with adequate medical training in catheter insertion
procedures should use the Volcano system. Only those personnel who are familiar with
its operation and who have been trained to perform the procedures for which this device
is intended should use the system.
System Use Cautions and Warnings
CAUTION: For the Volcano CORE system, you can easily roll it by holding the
hand grips on either side of the Control Console. Do not exceed a slow walking
pace when moving the system to reduce risk of causing the unit to topple which
may cause significant damage and/or operator injury.
CAUTION: A tipping hazard may occur if the unit is pushed while wheels are
immobilized.
The Volcano system supplies diagnostic information when used in conjunction
with the Volcano imaging catheters during ultrasonic imaging of peripheral and
coronary vasculature. It is intended to be used as an adjunct to conventional
angiographic procedures or interventional therapies such as balloon angioplasty.
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General