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

Overview
7
Connector
Description
AC Receptacle:
For connecting the AC power cord to the Control Unit.
Mounting Bracket:
Secures Control Unit to infusion stand or custom
EKOS™ CU 4.0 Cart.
USB Port:
Used by qualified personnel to download data and event
logs using only a USB memory stick.
Equipotential Terminal:
In the absence of adequate grounding on the A/C mains
power line, this terminal can be connected to a locally
available external equipotential line to prevent danger
caused by the difference in the potentials between this
device and other devices.
Side View
Figure 4. Side View of Control Unit
Connector Interface Cable
Attached for Storage
Attachment Bolt
Connector Interface
Cable Attachment
Bracket

Overview
8
Screen Layout – Prior to Connection
When the Control Unit is on, the display/touch screen provides helpful messages to
guide the operator through proper connection of the Connector Interface Cables and
device cables. The messages are provided for each channel independently and once
all cable connections are made the message will indicate the channel is ready to start
the ultrasound therapy. Additionally, the display/touch screen provides menu tabs to
navigate to other screens and indicates the current AC power/battery status (see Figure
5).
Figure 5. Example Screen – Prior to Connection
Item
Description
Home Tab:
Displays cable connection and system instructions, and
ultrasound runtime.
Information Tab:
Displays Control Unit model number and software
version, Connector Interface Cable and device
information and the EKOS help line phone number.
Graph Tab:
Displays a line graph that shows the percentage of the
maximum average power delivered for each channel.
Settings Tab:
Menu Tabs
Channel B
Message Area
Channel A
Message Area
AC Power / Battery Status

Overview
9
Item
Description
Displays a configuration menu for setting alert tone
volume, screen brightness and language.
AC Power / Battery Status Indicator:
Provides AC power and battery charge information
when the Control Unit is turned ON.
Disable Button:
Disables channel when “X” icon is pressed.
Disable button may be green, yellow or red.
Channel Identifier:
Indicates channel A or channel B.
Note: Messages and information associated with
channel A are provided in the message area on the left
side of the display; messages and information
associated with Channel B are provided in the message
area on the right side of the display.
Screen Layout – During Ultrasound Therapy
During ultrasound therapy, the display/touch screen provides helpful information to
monitor the ultrasound therapy. This information is provided for each channel
independently and channels can be interacted with separately. The channels are
labeled A and B and can provide energy for up to two devices at the same time.
Additionally, during ultrasound therapy, the display/touch screen continues to provide
menu tabs to navigate to other screens and indicates the current AC power/battery
status (see Figure 6)

Overview
10
Figure 6. Example Screen – During Ultrasound Therapy
Item
Description
Channel Identifier:
Indicates channel A or channel B.
Note: Messages and information associated with
Channel A are provided in the message area on the left
side of the display; messages and information
associated with Channel B are provided in the message
area on the right side of the display.
Ultrasound Runtime:
Displays the current runtime for the channel. Runtime is
the length of time a device has delivered ultrasound
therapy on a channel. Time is displayed in
Hours:Minutes:Seconds.
Running:
A green running indication is displayed when the
ultrasound therapy is ON. Additionally, white bands
animate in channel message area.
Menu Tabs
Channel B
Message Area
Channel A
Message Area
AC Power / Battery Status

Overview
11
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.
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

Safety Information
12
Safety Information
Warnings and Precautions
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.
WARNING!
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.
WARNING!
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.
WARNING!
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.
WARNING!
During normal use, ultrasound energy may cause a temperature rise in
the treatment zone. There are temperature sensors in the EkoSonic™
Endovascular Device. The EkoSonic™ Control Unit monitors and
controls the device temperature to limit the device temperature to a
maximum of 43° C.
WARNING!
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.
WARNING!
Never transmit output power (ultrasound therapy ON) from the Control
Unit to the EkoSonic™ 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

Safety Information
13
is damaged in this manner and then used to continue therapy, vascular
injury or tissue burns could occur.
WARNING!
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. Fluids may
cause the equipment to perform inaccurately or fail, which could result in
vascular injury. Additionally, fluids could result in fire or electric shock.
WARNING!
The Control Unit is intended for use with the EkoSonic™ 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.
WARNING!
The reusable Connector Interface Cable and Control Unit are NOT
STERILE. Use caution if maintaining a sterile operating field after
connecting to the EkoSonic™ Device. Failure to do so could result in
patient infection.
WARNING!
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.
WARNING!
Ensure all connectors are dry before connecting the Connector Interface
Cable to the Control Unit or the Connector Interface Cable to the
EkoSonic™ Device. If connectors do become wet, thoroughly dry prior
to use. Fluid in the connectors may affect sensor accuracy and result in
vascular injury.
WARNING!
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.
WARNING!
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.
WARNING!
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

Safety Information
14
infusion stand adhere to 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.
Failure to follow these guidelines could result in the infusion stand
tipping or equipment falling, resulting in bodily injury.
WARNING!
Always use the handle when carrying the Control Unit. Failure to do so
could cause the Control Unit to be dropped resulting in bodily injury.
WARNING!
Before transporting the patient or moving the Control Unit, unplug the
power cord from the wall outlet and secure the Connector Interface
Cable near the patient. Pulling of the EkoSonic™ Device may cause
the device to dislodge, loss of access and patient injury.
WARNING!
The Control Unit user interface presents a historical graph of the
ultrasound power delivered. The power data should not be used for
diagnostic purposes. Diagnosis of drug/ultrasound therapy should
always be made using other clinical diagnostic tools (e.g., fluoroscopy).
An incorrect diagnosis could result in prolonged therapy or inadequate
therapy.
WARNING!
Thoroughly clean the Control Unit and Connector Interface Cable after
each use. When cleaning, adhere to the following guidelines (See
Cleaning the Control Unit Section):
•Follow all cleaning instructions provided in these Instructions for
Use.
•Turn off the Control Unit and unplug it from the power source
before cleaning.
•Only use the recommended cleaning agents.
•Do not spray cleaners directly onto the Control Unit or Connector
Interface Cable.
•Do not expose the Control Unit or the Connector Interface Cable
to autoclaving or other sterilizers.
Failure to follow these cleaning guidelines could result in infection to the
patient or equipment damage.

Safety Information
15
WARNING!
Do not disassemble or modify the Control Unit. There are no operator
serviceable parts. Only the manufacturer or qualified personnel should
service the Control Unit. Improper disassembly of the Control Unit could
result in electric shock or burn.
Caution
The Control Unit is designed to be operated by trained hospital personnel
who are responsible for direct patient care in the setting of the
Angiography Lab and in-patient hospital wards. Control Unit operators
should have knowledge of endovascular therapy. All Control Unit
operators should receive in‐service training from an authorized EKOS™
trainer before operating this equipment.
Caution
Carefully read all instructions and precautionary information prior to use.
Failure to do so may result in improper operation of the device.
Caution
During use, the Control Unit should remain plugged into a hospital-grade
outlet. The battery is only intended to power the Control Unit for patient
transport. It is recommended that prior to transport the battery level be
checked to ensure it is adequate. Failure to plug in the AC power after
transport could result in the Control Unit turning OFF and delay of
ultrasound therapy.
Caution
After each use, the Control Unit should be plugged into a hospital-grade
outlet to ensure the battery is recharged fully. Failure to plug in the AC
power after use could result in the battery not being fully charged and
delay of ultrasound therapy.
Caution
When using the Control Unit, the ultrasound will not start or will
automatically shut off if certain conditions occur. An alert is presented on
the display and must be resolved before the ultrasound can be restarted.
Some of the conditions are:
•Connector Interface Cable disconnected.
•EkoSonic™ Device temperature is above the maximum limit.
•Ultrasonic Core and Infusion Catheter are incompatible.
•Blocking the ventilation of the Control Unit so that the Control Unit
becomes too hot.
During use, the Control Unit should be monitored for alerts. Failure to
resolve the issue could result in delay of ultrasound therapy.
Caution
When using the Control Unit, care should be taken to optimize the
display brightness and volume level for the use environment. Failure to
optimize could cause audible and visual information to be missed
resulting in delay of ultrasound therapy.

Safety Information
16
Caution
When using two EkoSonic™ Devices (one in channel A and one in
channel B), care should be taken to ensure that desired actions (e.g.,
start ultrasound, stop ultrasound, connect cables, disconnect cables,
respond to an alert message) are performed on the correct channel(s) or
device(s).
Caution
When using two EkoSonic™ 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.
Caution
Store the Control Unit in an area of good ventilation and under specified
conditions. (See Specifications Section). Failure to store the Control
Unit as specified could result in equipment failure leading to delay of
ultrasound therapy.
Caution
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