
14
Boston Scientic (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92310058G), IFU, MB, CU4, en, 51011236-001A
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
Note: 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�
WARNINGS
• 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�
• 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�
• 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�
• During normal use, ultrasound energy may cause a temperature rise in the treatment zone� There are temperature sensors in the EKOS
Device�The EKOS Control Unit monitors and controls the device temperature to limit the device temperature to a maximum of 43 °C�
• 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�
• Never transmit output power (ultrasound therapy ON) from the Control Unit to the EKOS 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 is damaged in this manner and then used
to continue therapy, vascular injury or burns could occur�
• Avoid spilling fluids on the cables and Control Unit� Do not immerse any portion of the cables or Control Unit in water or other fluids as
this may cause the equipment to perform inaccurately or fail, which could result in vascular injury, electric shock or fire�
• The Control Unit is designed for use with the EKOS Device, approved cables and electronic devices� Do not connect non-EKOS devices,
cables (e�g�, power cord) or electronic equipment to the Control Unit� Use of non-approved devices, cables and electronic equipment
could result in electric shock or burn, increased electromagnetic interference (EMI) emissions, decreased immunity to EMI from other
sources, or delay of therapy�
• The reusable Connector Interface Cable and Control Unit are NOT STERILE� Use caution if maintaining a sterile operating field after
connecting to the EKOS Device� Failure to do so could result in patient infection�
• Inspect all connectors, cables and the Control Unit for damage prior to use� If damaged (e�g�, exposed wires), do not use and replace
immediately�
• Ensure all connectors are dry before connecting the Connector Interface Cable to the Control Unit or the Connector Interface Cable to
the EKOS Device� If connectors do become wet, thoroughly dry prior to use� Fluid in the connectors may affect sensor accuracy and
result in vascular injury�
• Connect system cables only to their proper connectors as marked and ensure connections are secure� Failure to do so could result in
electric shock or burn�
• Secure device cables and the Connector Interface Cable using standard practices to preserve the integrity of the device, minimize
device movement at the insertion site, and prevent device dislodgement� If the Connector Interface Cable is dropped,it has sufficient
weight to pull on the device and possibly dislodge it from where it has been inserted into the patient�
• The Control Unit should be placed on a flat table or attached to the EKOS CU 4�0 Cart or an infusion stand during use� If attached to an
infusion stand adhere to the following guidelines (see Attaching the Control Unit to an Infusion Stand Section):
• Always use an infusion stand that meets the specifications in these Instructions for Use�
• Follow the mounting instructions described in these Instructions for Use to ensure the Control Unit is securely attached to the
infusion stand�
• Attach the Control Unit to a position on the infusion stand such that the combined weight of the infusion pumps and Control Unit
is as low as practical�
• When transporting the infusion stand or CU 4�0 Cart, hold the pole in the middle or use the handle if available to ensure the
best control�