EKOS Control System 4.0 User Manual

TABLE OF CONTENTS DEVICE DESCRIPTION... 6 Figure 1. EKOS Endovascular System (Power Cord Not Shown)... 6 Contents... 6 EKOS Device... 6 EKOS Control System 4.0... 6 Operating Principle...7 Overview...7 Table 1. ...7 Front View... 8 Figure 2. Front View of Control Unit... 8 Table 2... 8 Back View... 9 Figure 3. Back View of Control Unit... 9 Table 3...10 Side View...10 Figure 4. Side View of Control Unit...10 Screen Layout – Prior to Connection ...10 Figure 5. Example Screen-Prior to Connection... 11 Table 4... 11 Screen Layout – During Ultrasound Therapy ... 12 Figure 6. Example Screen-During Ultrasound Therapy... 12 Table 5... 12 Color Coding Glossary... 13 Table 6... 13 User Information... 13 Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92310058G), IFU, MB, CU4, en, 51011236-001B

INTENDED USE... 13 INDICATIONS FOR USE... 13 Clinical Benefit Statement... 13 Summary of Safety and Clinical Performance... 13 CONTRAINDICATIONS... 13 WARNINGS...14 PRECAUTIONS ... 15 ADVERSE EVENTS...16 CONFORMANCE TO STANDARDS...16 Classification...16 Electromagnetic Emissions Declarations... 17 Table 7. ... 17 Table 8... 17 Table 9...19

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HOW SUPPLIED...19 Device Details...19 Cleaning the Control Unit...19 Table 10... 20 Storing the Control Unit Within the Clinical Facility... 20 Environmental Conditions... 20 OPERATIONAL INSTRUCTIONS... 20 Expected Service Life... 21 Ultrasound Operation ... 21 System Configurations... 21 Figure 7. Settings Menu Screen...22 Figure 8. Language Selection Screen ...22 Figure 9. Language Confirmation Screen ...23 Preparing for Ultrasound Use...23 Figure 10. Boot Screen ...23 Figure 11. Logo Screen (Starting)...24 Using AC Power and Charging the Battery...24 AC Power / Battery Status Indicator...24 Table 11...25 Figure 12. Screen with AC Power/Battery Status...25 Battery Gauge...26 Table 12...26 Low Battery Notification...26 Figure 13. Low Battery Message...26 Critically Low Battery...27 Figure 14. Critically Low Battery...27 Figure 15. Battery Error Message ... 28 Battery Charging Indicator – Control Unit Turned Off... 28 Figure 16. Charging Indicator on Control Panel ... 28 Table 13... 28 Table 14... 29 Starting Ultrasound... 29 Figure 17. Activate Screen... 29 Figure 18. Connect Interface Cable Screen... 30 Figure 19. Connect Interface Cable Diagram... 30 Figure 20. Connect Device Cables Screen... 31 Figure 21. Connect Device Cables Diagram... 31 Figure 22. Connect Infusion Catheter Screen...32 Figure 23. Connect Ultrasonic Core Screen...32 Figure 24. Ready Screen...32 Figure 25. Reminder to Start Treatment Screen ...33

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Battery Error...27

Monitoring Ultrasound...33 Figure 26. One Channel with Ultrasound Running Screen ...33 Figure 27. Two Channels with Ultrasound Running Screen ...34 Figure 28. Ultrasound Paused/Ready Screen ...34 Figure 29. Ultrasound Paused/Ready Screen ...35 Transporting the Patient and Control Unit...35 Disposal...35 Completing Ultrasound...36 Figure 30. Ready Screen Showing Disable Button...36 Figure 31. Disable Confirmation Screen ...36 Figure 32. Disabled/Ready to Activate Screen ...36 Figure 33. Logo Screen (Shutting Down) ...37 INFORMATION TO BRIEF THE PATIENT...37 SYSTEM INFORMATION...37 Figure 34. System Information Screen ...37 Table 15... 38 TROUBLESHOOTING... 38 Power Graph... 38 Reading the Power Graph... 38 Figure 35. Power Graph Menu Tab... 38 Screen Layout – Power Graph... 38 Figure 36. Screen Layout-Power Graph... 39 Table 16... 39 Example Power Graphs... 40 Figure 37. Example-Two Channel Power Graph... 40 Figure 38. Example-Two Channel Power Graph, Device Changed... 40 Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92310058G), IFU, MB, CU4, en, 51011236-001B

Snapshot... 40 Figure 39. Example-Snapshot Power Graph...41 Troubleshooting...41 System Errors...41 Figure 40. Connection Error Screen...41 Figure 41. Temperature Error Screen...42 Technical Support...42 Table 17...42 Table 18...42 Channel Errors...43 Figure 42. Channel A Connection Error ... 44 Figure 43. Channel B Connection Error ... 44 Technical Support... 44 Table 19... 44 Table 20... 45

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Channel Messages... 48 Figure 44. Channel A Message... 48 Figure 45. Channel A and B Messages ... 48 INFUSION STAND... 49 Selecting the Appropriate Infusion Stand... 49 Table 21... 49 Attaching the Control Unit to an Infusion Stand... 50 Figure 46. Pole Inside Bracket ... 50 Figure 47. Turn Knob ... 50 Figure 48. Secure ... 51 SYMBOLS AND INDICATORS... 51 Table 22... 51 SPECIFICATIONS... 54 Table 23... 54 Table 24. Ordering Information... 54 WARRANTY... 54

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SYMBOL DEFINITIONS ... 54

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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.

EKOS Control Unit 4.0

Start

Start

Stop

Stop

A

B

Connector Interface Cable (Housing End of Connector Interface Cable) Infusion Catheter Connector

Ultrasonic Core Connector EKOS Device (Infusion Catheter + Ultrasonic Core)

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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.

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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. Precaution: 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. Operating Principle The EKOS 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 EKOS 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 EKOS Devices. These devices can deliver ultrasound therapy simultaneously, yet are controlled independently. Table 1. 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. Infusion Catheter:

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.

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Connects to the Connector Interface Cable. The Infusion Catheter is a multi-lumen catheter that delivers physician specified fluids into the vasculature.

Front View Display/Touch Screen

Hard Controls

Start

Start

Stop

Stop

A

B

Channel A Channel B Figure 2. Front View of Control Unit Table 2. Control/Indicator/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. Press and hold the button for 10 or more seconds to put the Control Unit into low power/battery-saving mode.

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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 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 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 %) • 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 battery does not start charging, a battery error may have occurred, call EKOS Help Line.

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CMYK /

Control/Indicator/Connector

Start

Start

Stop

Stop

A

B

Description

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.

Start

Ultrasound Start Button: Starts energy transmission for a specific channel when pressed.

Stop

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

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Service Panel/Port

Mounting Bracket

USB Port Equipotential Terminal

AC Receptacle

Figure 3. Back View of Control Unit

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Table 3. Connector

Description

AC Receptacle: For connecting the AC power cord to the Control Unit

Mounting Bracket: Secures Control Unit to infusion stand or EKOS CU 4.0 Cart.

USB Port: Used by Boston Scientific authorized 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

Attachment Bolt

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A B Connector Interface Cable Attachment Bracket

Connector Interface Cable Attached for Storage

Figure 4. Side View of Control Unit 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).

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Menu Tabs

AC Power/Battery Status

Channel A Message Area

Channel B Message Area

Figure 5. Example Screen-Prior to Connection Table 4 Item

Description Home Tab: Displays cable connection and system instructions, and ultrasound runtime.

i

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.

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Settings Tab: 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.

A B

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.

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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.) Menu Tabs

AC Power/Battery Status

Channel A Message Area

Channel B Message Area

Figure 6. Example Screen-During Ultrasound Therapy Table 5. Item

Description

A B

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.

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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.

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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

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. 13

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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.

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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-hospitalgrade 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.

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• •

•

•

•

PRECAUTIONS • 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. • 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. • 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. • 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. • 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. • EKOS 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. • 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. • When using two EKOS 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).

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•

Failure to follow these guidelines could result in the infusion stand tipping or equipment falling, resulting in bodily injury. 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. 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 EKOS Device may cause the device to dislodge, loss of access and patient injury. 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. 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. Do not disassemble or modify the Control Unit or CIC. There are no customer serviceable parts. Only the manufacturer or Boston Scientific authorized personnel should service the Control Unit and CIC. Improper disassembly of the Control Unit could result in electric shock or burn. Ensure the CIC is always exposed to an open-air environment and is never covered or placed under a blanket or exposed to venting from a warming blanket.

•

When using two EKOS 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. • Failure to store and operate the Control Unit as specified could result in equipment failure leading to delay of ultrasound therapy (See Specifications Section). • 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 from other devices, similar actions to increase the separation and isolation between the pieces of equipment should be attempted. This equipment also complies with requirements for safe operation when subjected to adverse power line conditions. If this occurs, solution delivery will continue, and the operator will be presented with an error message on the display. Resolving the error and restarting ultrasound therapy will resume normal operation. For further information about resolving error messages see the Troubleshooting Section.

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ADVERSE EVENTS 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. For specific observed and/or potential adverse events related to use of the EKOS Endovascular System please refer to the EKOS Device Instructions for Use. CONFORMANCE TO STANDARDS Classification Complies with ISO 60601-1, Edition 3. • Complies with ISO 60601-1-2 Class A Emissions Limits when used with the provided medical grade power cord, two Connector Interface Cables (700-10410), and two EKOS Devices, each consisting of an Infusion Catheter and an Ultrasonic Core. • Class I, Grounded Equipment • Type CF Patient Applied Parts, Defibrillation proof • Mode of Operation: Continuous, with automatic shut-off features • Control Unit water ingress rating: IPX2 • Connector Interface Cable water ingress rating: IPX4

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Electromagnetic Emissions Declarations Table 7. Guidance and manufacturer’s declaration – electromagnetic emissions The Control Unit is intended for use in the electromagnetic environment specified below. The customer or the user of the Control Unit should assure that it is used in such an environment. Emissions text

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 2

The Control Unit must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

The Control Unit is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: 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.

Table 8. Guidance and manufacturer’s declaration – electromagnetic immunity

IMMUNITY test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC 61000-4-2

± 8 kV contact

± 8 kV contact

± 15 kV air

± 15 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst IEC 61000-4-4

± 2 kV for power supply lines

± 2 kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

± 1 kV for input/output lines

Not Applicable

± 1 kV line(s) to line(s)

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

± 2 kV line(s) to earth

<5 % UT (>95 % dip in UT) for 0,5 cycle

<5 % UT (>95 % dip in UT) for 0,5 cycle

40 % UT (60 % dip in UT) for 5 cycles

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

70 % UT (30 % dip in UT) for 25 cycles

<5 % UT (>95 % dip in UT) for 5 s

<5 % UT (>95 % dip in UT) for 5 s

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Mains power quality should be that of a typical commercial or hospital environment

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Control Unit requires continued operation during power mains interruptions, it is recommended that the internal battery in the Control Unit be properly maintained and charged.

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Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92310058G), IFU, MB, CU4, en, 51011236-001B

The Control Unit is intended for use in the electromagnetic environment specified below. The customer or the user of the Control Unit should assure that it is used in such an environment.

Guidance and manufacturer’s declaration – electromagnetic immunity Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level. The Control Unit is intended for use in the electromagnetic environment specified below. The customer or the user of the Control Unit should assure that it is used in such an environment.

Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92310058G), IFU, MB, CU4, en, 51011236-001B

IMMUNITY test

IEC 60601 test level

Compliance level

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

Conducted RF IEC 61000-4-6

3 V/m 80 MHz to 2,5 GHz

3 V/m 80 MHz to 2,5 GHz

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Control Unit, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.17√P

d = 1.17√P 80 MHz to 800 MHz d = 2.33√P 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Control Unit is used exceeds the applicable RF compliance level above, the Control Unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Control Unit. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m. a

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Table 9. Recommended separation distances between portable and mobile RF communication equipment and the Control Unit The Control Unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Control Unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Control Unit as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d = 1.17√P

80 MHz to 800 MHz d = 1.17√P

800 MHz to 2,5 GHz d = 2.33√P

0,01

0.12

0.12

0.23

0,1

0.37

0.37

0.74

1

1.17

1.17

2.33

10

3.70

3.70

7.37

100

11.7

11.7

23.3

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. HOW SUPPLIED This product is supplied non-sterile and is intended for multiple use. Device Details Do not use if package is damaged or unintentionally opened before use. Do not use if labeling is incomplete or illegible Cleaning the Control Unit

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. Clean the Control Unit and Connector Interface Cable(s) after each use. 1. Turn OFF the Control Unit. 2. Unplug the power cord from the wall outlet. 3. Disconnect the power cord and Connector Interface Cable(s) from the Control Unit. 4. Wipe the Control Unit and cables with: • An approved cleaning and disinfection hospital wipe or • A mild cleaning solution applied with a damp soft cloth followed by application of a disinfection solution

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Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92310058G), IFU, MB, CU4, en, 51011236-001B

Warning: 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.

Note: Carefully clean the connector ports. Do not use excessive amounts of cleaning fluids. See table below for example cleaning and disinfection products. Table 10. Solution

Example Product

Up to 90 % isopropyl alcohol

Super Sani‐Cloth™ by PDI Healthcare

10 % solution of bleach and water

Sani‐Cloth™ Bleach by PDI Healthcare

5. Dry the Control Unit and Connector Interface Cable(s) as needed Storing the Control Unit Within the Clinical Facility To store the Control Unit and the Connector Interface Cable(s), follow these guidelines: 1. Store the Control Unit at room temperature, in a well-ventilated area. Caution: Failure to store and operate the Control Unit as specified could result in equipment failure leading to delay of ultrasound therapy. Note: For more information about storage and operating specifications see Specifications Section. Place Control Unit on a flat surface or attached to an EKOS CU 4.0 cart, or infusion stand, close to a hospital-grade outlet. 2. To maintain a fully charged battery, always connect the Control Unit to a hospital-grade outlet when not in use.

Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92310058G), IFU, MB, CU4, en, 51011236-001B

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. 3. An AC power / Battery Charging Indicator on the front of the Control Unit illuminates when the unit is turned OFF. For more information about the power and charging, see Power Section. 4. The Connector Interface Cable(s) may be stored on the side of the Control Unit by using the bracket on the back side of the cable housing. 5. Carefully route the power cord and Connector Interface Cable(s) to minimize the possibility of someone tripping. Environmental Conditions Operating Conditions: • Humidity: 30 % to 75 %, non-condensing • Temperature: +15 °C to +40 °C • Atmospheric Pressure: 73 kPa to 111 kPa External Storage/Transport Conditions: • Humidity: 10 % to 90 %, non-condensing • Temperature: -20 °C to +60 °C • Atmospheric Pressure: 73 kPa to 111 kPa OPERATIONAL INSTRUCTIONS Improper EKOS Control Unit 4.0 preparation or abnormal component operation will halt Control Unit operation and troubleshooting steps, or error messages may occur. If operation halts, refer to System Errors, Channel Errors, or Channel Messages in the Troubleshooting section. Required Items: • EKOS Device (1 or 2) • EKOS Connector Interface Cable (1 or 2) • Power Cord Note: Quantity for EKOS Devices and Connector Interface Cables depends on prescribed protocol by physician.

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