Safety Information
15
Do not disassemble or modify the Control Unit. There are no operator
serviceable parts. Only the manufacturer or qualified personnel should
service the Control Unit. Improper disassembly of the Control Unit could
result in electric shock or burn.
The Control Unit is designed to be operated by trained hospital personnel
who are responsible for direct patient care in the setting of the
Angiography Lab and in-patient hospital wards. Control Unit operators
should have knowledge of endovascular therapy. All Control Unit
operators should receive in‐service training from an authorized EKOS™
trainer before operating this equipment.
Carefully read all instructions and precautionary information prior to use.
Failure to do so may result in improper operation of the device.
During use, the Control Unit should remain plugged into a hospital-grade
outlet. The battery is only intended to power the Control Unit for patient
transport. It is recommended that prior to transport the battery level be
checked to ensure it is adequate. Failure to plug in the AC power after
transport could result in the Control Unit turning OFF and delay of
After each use, the Control Unit should be plugged into a hospital-grade
outlet to ensure the battery is recharged fully. Failure to plug in the AC
power after use could result in the battery not being fully charged and
delay of ultrasound therapy.
When using the Control Unit, the ultrasound will not start or will
automatically shut off if certain conditions occur. An alert is presented on
the display and must be resolved before the ultrasound can be restarted.
Some of the conditions are:
• Connector Interface Cable disconnected.
• EkoSonic™ Device temperature is above the maximum limit.
• Ultrasonic Core and Infusion Catheter are incompatible.
• Blocking the ventilation of the Control Unit so that the Control Unit
becomes too hot.
During use, the Control Unit should be monitored for alerts. Failure to
resolve the issue could result in delay of ultrasound therapy.
When using the Control Unit, care should be taken to optimize the
display brightness and volume level for the use environment. Failure to
optimize could cause audible and visual information to be missed
resulting in delay of ultrasound therapy.
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