Bost
on Scientific (Mast
er Br
and,
Spir
al Bound Manual T
empla
te
, 8
.5in x 11in Global,
923100
58G),
IFU
, MB,
CU4,
en,
5
1011236
-001A
Black (K) ∆E ≤5.0
Black (K) ∆E ≤5.0
13
Color Coding Glossary
Messages and icons are displayed to inform the operator of the state of the Control Unit and device(s)� The following color coding is used to
help communicate the importance of these messages and icons�
Table 6.
Color
Description
Example
GREEN
Used to indicate the channel is ready, running or generally
without issue�
Note:
Ultrasound is ON for channel A in this example
YELLOW
Used to indicate further steps are required to start the
ultrasound�
Note:
Ultrasound is OFF for channel A in this example
RED
Used to indicate there is an error or issue that requires
further steps to resolve�
Note:
Ultrasound is OFF for channel A in this example
User Information
The Control Unit is designed to be operated by medical personnel who have knowledge of endovascular interventional procedures and who
are responsible for direct patient care in the areas of the hospital where the unit is used� Optional in-service training from an authorized EKOS
or Boston Scientific trainer is available�
INTENDED USE
The EKOS Control System 4�0 is intended to be used with EKOS Endovascular Devices to employ high frequency (2 MHz - 3 MHz), low power
ultrasound to facilitate the infusion of physician-specified fluids, including procedural fluids and thrombolytics, into the pulmonary and/or
peripheral vasculature of adults�
INDICATIONS FOR USE
See EKOS Device Instructions for use for detailed information on indications for EKOS Devices�
Clinical Benefit Statement
The EKOS Endovascular System is intended to facilitate the administration of physician-specified fluids, including thrombolytics, and deliver
ultrasound to the peripheral vasculature or the pulmonary arteries� The clinical benefit can be measured by overall clinical outcomes,
including, but not limited to, improved right ventricular heart function and hemodynamic stability when treating PE or the ability to infuse
physician-specified fluids into the peripheral vasculature, along with low rates of hemorrhage, recurrent PE, and all-cause mortality�
Summary of Safety and Clinical Performance
For customers in the European Union, use the device name found in the labeling to search for the device’s Summary of Safety and Clinical
Performance, which is available on the European database on medical devices (Eudamed) website: https://ec�europa�eu/tools/eudamed�
CONTRAINDICATIONS
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� See the EKOS Device Instructions for Use for detailed information on contraindications for EKOS Devices�
/CMYK
