Device Description; Contents; Ekos Device; Ekos Control System 4�0 - Boston Scientific EKOS Control System 4.0 User Manual

ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician�

DEVICE DESCRIPTION

The EKOS Endovascular System (see Figure 1) consists of the EKOS Device and EKOS Control System 4�0� The EKOS Control System 4�0 consists
of the EKOS Control Unit 4�0 (Control Unit), Connector Interface Cable and power cord� This Instructions for Use is for the EKOS Control
System 4�0�
Figure 1. EKOS Endovascular System (Power Cord Not Shown)

Contents

One (1) Control Unit
One (1) Power Cord
One (1) Connector Interface Cable

EKOS Device

The EKOS Endovascular Device and the EkoSonic Endovascular Device are interchangeable names for the same device and from henceforth
will be referred to as the EKOS Device� The EKOS Device is a single-use sterile device, consisting of a multi-lumen Infusion Catheter and
an Ultrasonic Core that contains multiple transducers� The Infusion Catheter delivers the specified solutions to the target area while the
transducers simultaneously deliver ultrasound therapy to the same location�
See the EKOS Device Instructions for Use to get detailed information on preparation and placement of the EKOS Device� The instructions
for use packaged with the EKOS Device may still reference both Control System 4�0 and the previous EKOS Control System (PT-3B)� All EKOS
Devices will function as intended whether connected to a Control System 4�0 or PT-3B Control System�
EKOS Control System 4.0
The EKOS Control System 4�0 includes a portable Control Unit and reusable Connector Interface Cables� The Control Unit has two ports or
channels for Connector Interface Cable connections� The channels are labeled A and B and can provide energy for up to two devices at the
same time�
The Control Unit should be connected to AC power during operation but has an internal lithium-ion battery to power the Control Unit
temporarily during patient transport�
Black (K) ∆E ≤5.0
Infusion
Catheter
Connector
Ultrasonic Core
Connector
EKOS Control Unit 4.0
Start Start
Stop Stop
A B
Connector
Interface Cable
(Housing End of
Connector Interface
Cable)
EKOS Device
(Infusion Catheter + Ultrasonic Core)
6