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, 8
.5in x 11in Global,
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IFU
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CU4,
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5
1011236
-001A
Black (K) ∆E ≤5.0
Black (K) ∆E ≤5.0
• When using two EKOS Devices (one in channel A and one in channel B), care should be taken to not cross the device cables� Ensure
each pair of device cables is connected to a single Connector Interface Cable� If the device cables are crossed, ultrasound is not
operational and could result in delay of ultrasound therapy�
• Failure to store and operate the Control Unit as specified could result in equipment failure leading to delay of ultrasound therapy (See
Specifications Section)�
• This equipment has been tested and found to comply with the limits for medical devices in BS EN 60601‐1‐2. These limits are designed
to provide reasonable protection against harmful electromagnetic interference in a typical medical installation� However, portable and
mobile RF communications equipment can affect medical electrical equipment� Use of the Control Unit with a power cord or accessory
other than as specified in this Instructions for Use may result in increased electromagnetic interference (EMI) emissions or decreased
immunity to EMI from other sources� (See Specifications Section)�
This equipment generates, uses, and can radiate energy and, if not installed and used in accordance with the instructions, may cause harmful
interference to other devices in the vicinity or be affected by interference from other devices� There is no guarantee that interference will not
occur in a particular installation� If this equipment does cause harmful interference to other devices, which can be determined by turning this
equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving device�
• Increase the separation between the equipment�
• Connect this equipment into an outlet on a circuit different from that to which the other device(s) are connected�
• Consult the manufacturer for help�
If the Control Unit must be used directly adjacent to other equipment, observe the function of the Control Unit to verify normal operation in
that configuration� If this equipment is adversely affected by interference from other devices, similar actions to increase the separation and
isolation between the pieces of equipment should be attempted�
This equipment also complies with requirements for safe operation when subjected to adverse power line conditions� If this occurs, solution
delivery will continue, and the operator will be presented with an error message on the display� Resolving the error and restarting ultrasound
therapy will resume normal operation� For further information about resolving error messages see the Troubleshooting Section�
ADVERSE EVENTS
The EKOS Control System 4�0 is intended for use with EKOS Devices� The EKOS Control System 4�0 and the EKOS Device together comprise the
EKOS Endovascular System; the EKOS Control System 4�0 cannot perform its intended purpose without the EKOS Device�
The Instructions for Use for the EKOS Control System 4�0 and the EKOS Device must each be followed for all endovascular interventional
procedures� For specific observed and/or potential adverse events related to use of the EKOS Endovascular System please refer to the EKOS
Device Instructions for Use�
CONFORMANCE TO STANDARDS
Classification
Complies with ISO 60601-1, Edition 3�
• Complies with ISO 60601-1-2 Class A Emissions Limits when used with the provided medical grade power cord, two Connector Interface
Cables (700-10410), and two EKOS Devices, each consisting of an Infusion Catheter and an Ultrasonic Core�
• Class I, Grounded Equipment
• Type CF Patient Applied Parts, Defibrillation proof
• Mode of Operation: Continuous, with automatic shut-off features
• Control Unit water ingress rating: IPX2
• Connector Interface Cable water ingress rating: IPX4
