Safety Information
12
Safety Information
Warnings and Precautions
The following warning and precaution statements provide important information for safe
operation of the Control Unit. Observe all warnings and precautions provided in these
Instructions for Use. Failure to do so may result in patient injury, operator injury or
product damage.
WARNING!
Do not operate the Control Unit in the presence of oxygen-rich
atmospheres, flammable anesthetics, or other flammable agents. Using
the unit in such environments could result in a fire or explosion.
WARNING
!
Do not place the Control Unit, Connector Interface Cable and/or Control
Unit power cord in the presence of high magnetic fields created by a
Magnetic Resonance Imaging (MRI) device. The high magnetic field
generated by an MRI device can attract the equipment with a force
sufficient to cause death or serious personal injury to persons between
the equipment and the MRI device. This magnetic attraction could
result in damage and affect the performance of the equipment.
WARNING
!
This equipment/system is intended for use by healthcare professionals
only. This equipment/system may cause radio interference or may
disrupt the operation of nearby equipment. It may be necessary to take
mitigation measures, such as re-orienting or relocating the Control Unit
or shielding the location.
WARNING!
During normal use, ultrasound energy may cause a temperature rise in
the treatment zone. There are temperature sensors in the EkoSonic™
Endovascular Device. The EkoSonic™ Control Unit monitors and
controls the device temperature to limit the device temperature to a
maximum of 43° C.
WARNING!
Connect the Control Unit only to a properly grounded hospital-grade
outlet using the specified power cord. Use of a non-hospital-grade
outlet could result in electric shock or burn. Use of a non-specified
power cord could result in increased electromagnetic interference (EMI)
emissions or decreased immunity to EMI from other sources.
WARNING
!
Never transmit output power (ultrasound therapy ON) from the Control
Unit to the EkoSonic™ Device unless it is placed within the patient
anatomy, solution is running through the drug lumen, and coolant is
flowing through the coolant lumen.
Always turn OFF the ultrasound
before removing the Ultrasonic Core from the Infusion Catheter
,
otherwise, overheating of the device may occur, potentially causing
damage to the device, burns and/or interruption of therapy. If the device
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