BTG EKOS User manual

EKOS™ Control System 4.0
Instructions for Use
Caution: Federal law restricts this device to use by or on the order of a physician.
Part number: 8490‐099 Rev J

Manufacturer
EKOS™ Corporation
11911 North Creek Pkwy South
Bothell, WA 98011 USA
T: (425) 415‐3100
F: (425) 415‐3102
Authorized Representative
Dr. Hans‐Joachim Lau
Airport Center (Haus C)
Flughafenstrasse 52a
22335 Hamburg, Germany
F: [phone]‐100
This equipment conforms to essential requirements of the
Medical Device Directive 93/42/EEC, as amended by
2007/47/EC, and complies with the Restriction of
Hazardous Substances Directive (RoHS) 2011/65/EU.
For Support
Outside the U.S.
Contact your local EKOS
representative
or call +1‐425‐415.3100
EKOS™, the EKOS Logo™, EkoSonic™, and MicroSonic™ are trademarks of
EKOS Corporation, a BTG International group company.BTG and the BTG
roundel logo are registered trademarks of BTG International Ltd. All rights
reserved. In addition, various other page elements may be trademarks claimed
by EKOS, including page headers, icons, graphics and scripts.
All other trademarks not owned by EKOS, but that appear in this document, are
the property of their respective owner(s).
Copyright ©2017 EKOS Corporation, a BTG International group company. All
rights reserved.
Publication date: November 2018

Table of Contents
General Information......................................................................................................... 1
Introduction.................................................................................................................. 1
EkoSonic™ Device ...................................................................................................... 2
EKOS™ Control System 4.0........................................................................................ 2
Intended Use ............................................................................................................... 3
Contraindications......................................................................................................... 3
Principles of Operation ................................................................................................ 3
Overview ......................................................................................................................... 3
Component Glossary................................................................................................... 3
Front View ................................................................................................................... 4
Back View.................................................................................................................... 6
Side View..................................................................................................................... 7
Screen Layout – Prior to Connection........................................................................... 8
Screen Layout – During Ultrasound Therapy............................................................... 9
Color Coding Glossary............................................................................................... 11
Safety Information ......................................................................................................... 12
Warnings and Precautions......................................................................................... 12
Power ............................................................................................................................ 17
Using AC Power and Charging the Battery................................................................ 17
AC Power / Battery Status Indicator .......................................................................... 18
Battery Gauge ........................................................................................................... 19
Low Battery Notification ............................................................................................. 20
Critically Low Battery ................................................................................................. 21
Battery Error .............................................................................................................. 22
Battery Charging Indicator – Control Unit Turned Off ................................................ 23
Ultrasound Operation .................................................................................................... 25
Preparing for Ultrasound Use .................................................................................... 25
Starting Ultrasound.................................................................................................... 27
Monitoring Ultrasound................................................................................................ 32

Completing Ultrasound .............................................................................................. 34
Using an Infusion Stand or EKOS™ CU 4.0 Cart.......................................................... 36
Selecting the Appropriate Infusion Stand................................................................... 37
Attaching the Control Unit to an Infusion Stand ......................................................... 37
Transporting the Patient and Control Unit ..................................................................... 39
Maintaining the Control Unit .......................................................................................... 40
Cleaning the Control Unit........................................................................................... 40
Storing the Control Unit ............................................................................................. 41
Disposal..................................................................................................................... 42
System Information ....................................................................................................... 42
Power Graph ................................................................................................................. 43
Reading the Power Graph ......................................................................................... 43
Screen Layout – Power Graph .................................................................................. 44
Example Power Graphs............................................................................................. 45
Snapshot ................................................................................................................... 46
System Configurations .................................................................................................. 47
Audible Alert Volume ................................................................................................. 48
Screen Brightness ..................................................................................................... 48
Selecting Language................................................................................................... 48
Troubleshooting ............................................................................................................ 49
System Errors............................................................................................................ 49
Channel Errors .......................................................................................................... 51
Channel Messages.................................................................................................... 54
Symbols and Indicators ................................................................................................. 55
Specifications ................................................................................................................ 62
System Specifications................................................................................................ 62
Electromagnetic Emissions Declarations................................................................... 64

General Information
1
General Information
Introduction
The EkoSonic™ Endovascular System consists of the EkoSonic™ 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 (see Figure 1).
EKOS™ Control Unit 4.0
Connector
Interface
Cable
Infusion
Catheter
Connector
EkoSonic™ Device
(Infusion Catheter + Ultrasonic Core)
Ultrasonic Core
Connector
Figure 1. EkoSonic™ Endovascular System (Power Cord Not Shown)
(Housing End of
Connector
Interface Cable)

General Information
2
EkoSonic™ Device
The EkoSonic™ Device (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 EkoSonic™ Device Instructions for Use to get detailed information on
preparation and placement of the EkoSonic™ Device. The instructions for use
packaged with the EkoSonic™ Device may still reference both Control System 4.0 and
the previous EkoSonic™ Control System (PT-3B) or may reference only the PT-3B
Control System. All EkoSonic™ Devices will function as intended whether connected to
a PT-3B Control System or Control System 4.0.
EKOS™ Control System 4.0
The 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.
The Control Unit provides electrical energy to the transducers of the Ultrasonic Core
and monitors the device temperature during ultrasound therapy. The temperature data
is used to automatically optimize ultrasound therapy to the treatment area. The Control
Unit also allows the operator to monitor, control and troubleshoot operation of the
device.
The ultrasound therapy delivered during operation disperses the solutions delivered into
the treatment area via the Infusion Catheter. The solutions are controlled by user
supplied infusion pumps or syringes.
Caution
This document provides instructions for operating the Control Unit, as
well as configuration, maintenance and troubleshooting information. It is
important that all persons using the Control Unit read and understand all
the information contained in these instructions prior to use.
The Control Unit is designed to be operated by trained medical personnel who have
knowledge of endovascular therapy and who are responsible for direct patient care in
the setting of the Cardiac Cath Lab, Interventional Radiology Lab, Critical Care Unit,
Cardiac Care Unit, or other areas of the hospital where the unit is used. All Control Unit

Overview
3
operators should receive in-service training from an authorized EKOS™ trainer before
operating this equipment.
Intended Use
The Control Unit is intended exclusively for use with EKOS™ Devices.
Contraindications
See the EkoSonic™ Device Instructions for Use to get detailed information on
contraindications for EKOS Devices.
Principles of Operation
The EkoSonic™ Endovascular System generates ultrasonic waves at the Infusion
Catheter treatment zone through the piezoelectric transduction of radio-frequency (RF)
energy generated by the Control Unit. The ultrasound emanates radially from the
treatment zone into and through blood, thrombus, or tissue surrounding the treatment
zone, within the patient’s vasculature. The ultrasound acts locally to increase the
dispersion of the delivered solutions into the treatment region.
In addition to generating the prescribed ultrasound therapy profile, the Control Unit
continually monitors output power and temperature of the EkoSonic™ Device. The
system has safeguards to prevent deviation of these parameters from preset ranges.
Overview
This section provides a basic orientation to the Control Unit controls, components,
connectors and screens. The Control Unit is comprised of a single display with an
integrated touch screen and a set of hard controls. The display/touch screen and the
hard controls are configured to operate up to two EkoSonic™ Devices. These devices
can deliver ultrasound therapy simultaneously, yet are controlled independently.
Component Glossary
Component
Description
Connector Interface Cable:
Used to connect the Infusion Catheter and Ultrasonic
Core to the Control Unit.
Note: This is sometimes referred to as the CIC.

Overview
4
Component
Description
Infusion Catheter:
Connects to the Connector Interface Cable. The
Infusion Catheter is a multi-lumen catheter that delivers
physician specified fluids into the vasculature.
Note: This is sometimes referred to as the Intelligent™
Drug Delivery Catheter (IDDC).
Ultrasonic Core:
Connects to the Connector Interface Cable. The
Ultrasonic Core incorporates up to thirty fully
encapsulated, radiopaque piezoelectric ceramic
ultrasound transducers along the distal length of the
shaft. The transducers emit ultrasound therapy radially
along the axis of the treatment zone.
Note: This is sometimes referred to as the MicroSonic™
Device (MSD).
Front View
Figure 2. Front View of Control Unit
Display/Touch Screen
Channel A
Channel B
Hard Controls

Overview
5
Control/
Indictor/
Connector
Description
Power Button:
Turns the Control Unit ON and OFF. When the Control
Unit is ON, a green LED illuminates. Press and hold the
button for 3 seconds to turn the Control Unit OFF.
Audio Pause Button:
Silences the audio alert tone for 5 minutes when
pressed. Pressing the button when audio is silenced
turns ON the audio alert tone.
Note:
When audio alert tone is ON, the alert icon
displays on the screen.
When the audio alert tone is silenced, the alert
icon is crossed-out indicating audio is silenced.
AC Power/Battery Charging Indicator:
Illuminates when the Control Unit is OFF, indicating
battery charge status. (Note: this icon is not visible when
the Control Unit is ON.)
When the Control Unit is connected to AC power:
•Steady green indicates battery is fully charged.
•Steady yellow indicates battery is charging.
•Blinking red (once per second) indicates a
battery error.
When the control Unit is not connected to AC power:
•Blinking red (once every 10 seconds) reminds to
plug into AC power. (Charge is greater than
30%.)
•Blinking red (once every 10 seconds) and an
audible alert indicates the battery has reached a
low charge state and reminds to plug into AC
power immediately. (Charge between 20% and
30%.)
•No light indicates the battery has reached a
critically low state causing the Control Unit to
enter a battery saving mode. (Charge less than
20%.) Plug into AC power immediately. If the

Overview
6
Control/
Indictor/
Connector
Description
battery does not start charging, a battery error
may have occurred, call EKOS Help Line.
Ultrasound Channel:
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.
Ultrasound Start Button:
Starts energy transmission for a specific channel when
pressed.
Ultrasound Stop Button:
Stops energy transmission for a specific channel when
pressed.
Connector Interface Cable Receptacle:
For connecting the Connector Interface Cable(s) to the
Control Unit.
Display/Touch Screen:
Shows ultrasound and battery information; and other
messages, settings and soft key buttons.
Back View
Figure 3. Back View of Control Unit
AC Receptacle
USB Port
Mounting Bracket
Equipotential
Terminal
Service
Panel/Port