EKOS Control System 4.0 Instructions for Use

Transcription

1 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: Rev J

2 Manufacturer EKOS Corporation North Creek Pkwy South Bothell, WA USA T: (425) F: (425) Authorized Representative Dr. Hans Joachim Lau Airport Center (Haus C) Flughafenstrasse 52a Hamburg, Germany F: 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 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

3 Table of Contents General Information... 1 Introduction... 1 EkoSonic Device... 2 EKOS Control System 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 Safety Information Warnings and Precautions Power Using AC Power and Charging the Battery AC Power / Battery Status Indicator Battery Gauge Low Battery Notification Critically Low Battery Battery Error Battery Charging Indicator Control Unit Turned Off Ultrasound Operation Preparing for Ultrasound Use Starting Ultrasound Monitoring Ultrasound... 32

4 Completing Ultrasound Using an Infusion Stand or EKOS CU 4.0 Cart Selecting the Appropriate Infusion Stand Attaching the Control Unit to an Infusion Stand Transporting the Patient and Control Unit Maintaining the Control Unit Cleaning the Control Unit Storing the Control Unit Disposal System Information Power Graph Reading the Power Graph Screen Layout Power Graph Example Power Graphs Snapshot System Configurations Audible Alert Volume Screen Brightness Selecting Language Troubleshooting System Errors Channel Errors Channel Messages Symbols and Indicators Specifications System Specifications Electromagnetic Emissions Declarations... 64

5 General Information 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 (Housing End of Connector Interface Cable) Infusion Catheter Connector Ultrasonic Core Connector EkoSonic Device (Infusion Catheter + Ultrasonic Core) Figure 1. EkoSonic Endovascular System (Power Cord Not Shown) 1

6 General Information EkoSonic Device The EkoSonic Device (device) is a single-use sterile device, consisting of a multilumen 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 2

7 Overview 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. 3

8 Overview 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 Display/Touch Screen Hard Controls Channel A Channel B Figure 2. Front View of Control Unit 4

9 Overview 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 5

10 Overview 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 Mounting Bracket Service Panel/Port USB Port Equipotential Terminal AC Receptacle Figure 3. Back View of Control Unit 6

11 Overview 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 Attachment Bolt Connector Interface Cable Attachment Bracket Connector Interface Cable Attached for Storage Figure 4. Side View of Control Unit 7

12 Overview 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). Menu Tabs AC Power / Battery Status Channel A Message Area Channel B Message Area 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: 8

13 Overview 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) 9

14 Overview Menu Tabs AC Power / Battery Status Channel A Message Area Channel B Message Area 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. 10

15 Overview 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 11

16 Safety Information 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 12

17 Safety Information 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 13

18 Safety Information 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. 14

19 Safety Information 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 Caution Caution Caution Caution Carefully read all instructions and precautionary information prior to use. Failure to do so may result in improper operation of the device. 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. 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. 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. 15

20 Safety Information Caution 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). 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 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. This equipment has been tested and found to comply with the limits for medical devices in BS EN 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 16

21 Power 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. Power The Control Unit operates on AC power or its internal lithium-ion battery. The system can switch from battery to AC power or from AC power to battery while the Control Unit is turned ON. Unplugging the AC power cord will automatically switch the Control Unit to battery power. Note: During operation on battery, output power to the EkoSonic Device(s) is reduced to 50% to prolong battery life. The Control Unit should be plugged into AC power whenever possible during operation to ensure full output power. 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. Using AC Power and Charging the Battery The Control Unit operates on AC power or an internal lithium-ion battery. Important battery information: During use, the Control Unit should be plugged into a hospital-grade outlet. When disconnected from an outlet the Control Unit automatically operates on battery power. The battery is intended to only power the Control Unit during patient transport or for short periods when AC power is unavailable. It is recommended that prior to patient transport the battery level be checked to ensure it is adequate. Whenever possible plug the Control Unit into a hospital-grade outlet to operate using AC power and automatically recharge the battery. 17

22 Power A fully charged battery provides power for approximately 2 hours if one channel is providing therapy or 1 hour if two channels are providing therapy. Connect the Control Unit to AC power after each use to recharge the battery. Typically, a fully depleted battery will recharge to full capacity in approximately 4 hours. 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. AC Power / Battery Status Indicator When the Control Unit is turned ON and connected to AC power, an indicator is displayed showing the connection and battery charging status. Item Description Connected to AC power and battery is charging. Connected to AC power and battery is fully charged. If the battery is defective the battery icon is red with an X. The battery charge level (shown in %) is displayed in the upper right corner of the display, next to the AC power / battery status indicator (see Figure 7). AC Power / Battery Status 18

23 Power Figure 7. Screen with AC Power/Battery Status Battery Gauge When the Control Unit is turned ON and is powered by the battery, a battery gauge shows the level of battery charge. As battery charge decreases, the battery gauge shows the decrease in battery charge. The battery gauge with a red bar indicates a very low or fully depleted battery. Item Description 76% - 100% 51% - 75% 26% - 50% 16%-25% 0% - 15% If the battery is defective the battery icon is red with an X. 19

24 Power Low Battery Notification If the Control Unit is operating on battery power and the battery charge level is 15% or less, a low battery message with an alert icon displays and an audible alert sounds. The percentage of remaining charge and the battery gauge with a red bar in the upper right corner of the display indicates the level of battery charge. Connect to AC power to continue to use the Control Unit. The message remains on the display and the tone repeats every minute until the Control Unit is connected to AC power or the Dismiss button on the touchscreen is pressed (see Figure 8). Note: If the Dismiss button was pressed and the battery charge level drops to 10%, the low battery message and alert is repeated. 20

25 Power Battery Power / Battery Gauge Figure 8. Low Battery Message Critically Low Battery If the Control Unit is operating on battery power and the battery charge level is 5% or less, the critically low battery message with an alert icon displays and an audible alert sounds. The percentage of remaining charge and the battery gauge with a red bar in the upper right corner of the display indicates the level of battery charge. Ultrasound runtime for each channel is displayed during a critically low battery notification. Immediately connect the Control Unit to AC power to prevent the unit from automatically shutting down in 3 minutes. A countdown timer is displayed indicating how much time remains before the Control Unit will shut down (see Figure 9). Figure 9. Critically Low Battery 21

26 Power Note: In the event the time elapses and the Control Unit automatically shuts down, the ultrasound runtime will be saved. Infusion of the solutions will not be interrupted since the solutions are delivered by a separate infusion pump. Once the Control Unit is plugged into AC power, turned back ON and ultrasound is started, the runtime will resume for each channel where it left off. Battery Error During operation on AC power, if the internal battery cannot provide power to the Control Unit, a battery error message with an alert icon displays. The red battery gauge with an X indicates the battery is defective. Even with a battery error, the Control Unit can continue to operate as long as it is connected to AC power. Do not attempt to open the Control Unit and change the battery. Contact your EKOS representative for information on replacing the battery. The battery error notification is dismissed by pressing the Dismiss button on the touch screen. The battery error notification appears whenever the Control Unit is connected to AC power, is turned ON and a battery error is detected (see Figure 10). If a battery error occurs when the Control Unit is not plugged into AC power, the Control Unit may not power up when the power button is pressed. If the Control Unit does power up, a system error message will display indicating the Control Unit will shut down in three minutes. If the Control Unit is turned ON when the battery error occurs, the Control Unit will immediately turn off. To bypass these battery errors, plug the Control Unit into AC power, power ON and operate normally. Note: In the event that the battery is fully depleted or a battery error occurs and the Control Unit automatically turns OFF, infusion of the solutions will not be interrupted. 22

27 Power Figure 10. Battery Error Message Battery Charging Indicator Control Unit Turned Off When the Control Unit is turned OFF, a battery icon is illuminated on the front of the Control Unit to indicate the battery charging status. (see Figure 11). Charging Indicator Figure 11. Charging Indicator on Control Panel The charging indicator on the front of the Control Unit changes color to indicate the charging status. If the battery reaches a critically low state the Control Unit enters battery saving mode and the charging indicator is not illuminated. 23

28 Power Indicator Control Unit Turned Off & AC Connected Description Steady green indicates Control Unit is connected to AC power and battery is fully charged. Steady yellow indicates Control Unit is connected to AC power and battery is charging. Blinking red (once per second) indicates Control Unit is connected to AC power and has a battery error. (Blinking) Control Unit Turned Off & AC Not Connected Indicator (Blinking) (Blinking + Audible Alert) Description Blinking red (once every 10 seconds) indicates Control Unit is not connected to AC power and reminds to plug into AC power (Charge greater than 30%.) Blinking red (once every 10 seconds) and an audible alert indicates Control Unit is not connected to AC, the battery has reached a low charge state, and reminds to plug into AC power immediately. (Charge between 20% and 30%.) Battery icon not illuminated while the Control Unit is turned OFF indicates: (Not illuminated) AC power is not connected and battery has reached a critically low state, causing the Control Unit to enter battery saving mode. (Charge less than 20%.) Plug into AC power immediately. OR AC power is not connected and battery has an error. Note: Connecting the Control Unit to AC power and pressing the Power button will bring the Control Unit out of its low power/battery saving mode. 24

29 Ultrasound Operation Ultrasound Operation 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! 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! 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. Caution 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). 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. Preparing for Ultrasound Use 1. Verify the Control Unit is securely attached to the recommended infusion stand, EKOS CU 4.0 Cart, or placed on a table near the patient. 25

30 Ultrasound Operation 2. Connect the Control Unit power cord to an appropriate hospital-grade outlet. 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. 3. Press the Power button on the front of the Control Unit. The EKOS boot screen followed by the logo screen display while the Control Unit performs its initial hardware and software test (see Figure 12 and Figure 13). Figure 12. Boot Screen 26

31 Ultrasound Operation Figure 13. Logo Screen (Starting) Starting Ultrasound The sterile, disposable EkoSonic Device is sold separately. Carefully read the Instructions for Use that is provided with the device for a complete description, instructions, warnings, cautions and specifications specific to the EkoSonic Device. The Instructions for Use packaged with the EkoSonic Device may still reference the previous Control System (PT-3B) and terminology. All EkoSonic Devices will function as intended whether connected to a model PT-3B Control System or a Control System 4.0. After the physician has placed the EkoSonic Device into the patient, do the following: 1. If not already ON, press the Power button on the front of the Control Unit. When the Control Unit start-up is complete and if the Connector Interface Cable is not connected, both channels are available to Activate (see Figure 14). 27

32 Ultrasound Operation Figure 14. Activate Screen Pressing the Activate button for either channel displays a connect message indicating to plug the Connector Interface Cable into the Control Unit (see Figure 15). Figure 15. Connect Interface Cable Screen Note: If the Connector Interface Cable is already connected when the Control Unit is turned ON, the channel is automatically activated and a connect device cables message is displayed (see Figure 17). Similarly, if the Connector Interface Cable is connected after the Control Unit is turned ON, the channel is automatically activated and a connect device cables message is displayed (see Figure 17). 28

33 Ultrasound Operation 2. Connect the Connector Interface Cable to the channel A or B receptacles on the front panel of the Control Unit by inserting the Connector Interface Cable until a click is heard. Note: The Connector Interface Cable can be used in either channel A or B. If providing ultrasound therapy to two devices, connect one Connector Interface Cable to each receptacle (see Figure 16). A or B illuminates on the Connector Interface Cable housing once connected to the Control Unit. A or B indicates the channel to which the cable is connected. Figure 16. Connect Interface Cable Diagram After the Connector Interface Cable is connected to the Control Unit, a connect message displays indicating to connect the device connectors to the Connector Interface Cable (see Figure 17). 29

34 Ultrasound Operation Figure 17. Connect Device Cables Screen 3. Connect the Ultrasonic Core to the Connector Interface Cable (see Figure 18). 4. Connect the Infusion Catheter to the Connector Interface Cable (see Figure 18). Ultrasonic Core Infusion Catheter Figure 18. Connect Device Cables Diagram If the device is not properly connected, a connect message displays indicating the specific device cable that needs to be connected (Infusion Catheter or the Ultrasonic Core) (see Figure 19 and Figure 20). 30

35 Ultrasound Operation Figure 19. Connect Infusion Catheter Screen Figure 20. Connect Ultrasonic Core Screen Once the device is properly connected, a ready message displays indicating the Control Unit is ready (see Figure 21). Figure 21. Ready Screen 5. Turn on the drug and coolant pumps, and set the specified flow rate per the physician s orders and within the flow rates specified in the EkoSonic Device Instructions for Use. 6. Secure the housing end of the Connector Interface Cable near the patient using standard hospital practices. 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. 31

36 Ultrasound Operation 7. Press the Start button on the Control Unit for the appropriate channel, when prompted (see Figure 22). 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 is damaged in this manner and then used to continue therapy, vascular injury or tissue burns could occur. Note: If the Start button is not pressed within 5 minutes of successfully connecting the device, the reminder alert tone activates, the alert icon appears on the display, and the Ready title bar flashes alternating between white and yellow. Pressing the Audio Pause button reminder for 5 minutes. on the Control Unit silences the Figure 22. Reminder to Start Treatment Screen Monitoring Ultrasound 1. Confirm ultrasound therapy is running or ON. 32

37 Ultrasound Operation When ultrasound is running, a runtime clock counts up, white bands animate in the channel message area and a green Running indication displays. The running status is displayed independently for each channel or device (see Figure 23 and Figure 24). Figure 23. One Channel with Ultrasound Running Screen Figure 24. Two Channels with Ultrasound Running Screen 2. Monitor the runtime clock to determine how long the channel has delivered ultrasound therapy. The runtime is shown as Hours:Minutes:Seconds. Time segments not yet reached are dimmed. In the example below, ultrasound therapy has been running for 23 minutes and 47 seconds (see Figure 25). Hours Minutes Seconds Figure 25. Runtime Clock Note: The runtime information is saved for the channel, not for the device connected. If the ultrasound therapy is stopped and restarted, the timer will resume when the ultrasound therapy is started again. If the device cables are disconnected (e.g., patient transport) and re-connected the channel timer will resume when ultrasound therapy is started again. It is strongly recommended that devices be reconnected to the same channel they started on to ensure the total runtime displayed for the channel reflects the total runtime for the device. Note: During normal use, ultrasound therapy may cause a temperature rise in the treatment zone. There are temperature sensors in the EkoSonic 33

38 Ultrasound Operation Device. The control unit monitors the device temperature and optimizes the output power to the treatment area. 3. To stop or pause the ultrasound, press the Stop button on the Control Unit for the appropriate channel. When the Stop button is pressed, the ready to start instruction is displayed indicating the total elapsed runtime for the ultrasound therapy (see Figure 26). Figure 26. Ultrasound Paused/Ready Screen 8. To restart the ultrasound, press the Start button on the Control Unit for the appropriate channel. The runtime will resume from the time at which it was stopped. If the Start button is not pressed within 5 minutes the start reminder activates. Completing Ultrasound Ultrasound therapy can be provided for an individual device on a single channel or two devices using both channels. Because each channel operates independently, ultrasound can be stopped and completed for one or both channels at any time. 1. Press the Stop button on the Control Unit for the appropriate channel. 2. If desired, press the Disable X icon for the appropriate channel to inactivate or disable the channel no longer in use (see Figure 27). 34

39 Ultrasound Operation Figure 27. Ready Screen Showing Disable Button Press the Disable icon on the confirmation screen and the channel becomes inactive (see Figure 28 and Figure 29). Figure 28. Disable Confirmation Screen Figure 29. Disabled/Ready to Activate Screen 3. Disconnect the Infusion Catheter and Ultrasonic Core from the Connector Interface Cable. 4. Press and hold the Power button for 3 seconds to turn OFF the Control Unit. The shutdown screen displays as the Control Unit shuts down (see Figure 30). Note: If the Power button is pressed and held for 10 seconds or more it will force the Control Unit into a low power/battery saving mode and data may be lost. In this mode the battery charging indicator on the front panel will not illuminate. Connecting the Control Unit to an AC power source and turning the Control Unit on will bring it out of the low power/battery saving mode. 35

40 Using an Infusion Stand or EKOS CU 4.0 Cart Figure 30. Logo Screen (Shutting Down) 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. 5. The Connector Interface Cable may be stored on the side of the Control Unit (see Figure 4). It is not recommended that the Connector Interface Cable be placed on the side of the Control Unit during ultrasound therapy because the cord lengths are restricted. 6. See Maintaining the Control Unit section for instructions on cleaning and storing the Control Unit. Using an Infusion Stand or EKOS CU 4.0 Cart During use or storage, the Control Unit can be attached to the custom designed EKOS CU 4.0 Cart or an infusion stand that meets at least the minimum specifications. Alternatively, the Control Unit can be placed on a flat table or cart. Note: For more information on the EKOS Cart see the EKOS CU 4.0 Cart Instructions for Use. Note: EKOS CU 4.0 Cart may not be available in all geographic regions. 36

41 Using an Infusion Stand or EKOS CU 4.0 Cart 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 infusion stand adhere to following guidelines: 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 infusion stand. Attach the Control Unit and infusion pumps 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, hold the pole in the middle or use the handle if available to ensure the best control. Always evaluate infusion stand stability for use environment after configuring for treatment. Failure to follow these guidelines could result in the infusion stand tipping or equipment falling, resulting in bodily injury. Selecting the Appropriate Infusion Stand Use this guideline when selecting an infusion stand for mounting the Control Unit. Component Pole diameter: Specification Minimum in. (1.9cm) Maximum in. (3.2cm) Pole Height: Maximum - 100in. (254.0cm) Base: Minimum Number of Legs/Casters - 6 Minimum Diameter - 25in.. (63.5cm) Mimimum Safe Working 100Lbs. (45.4kg) Load: Material: Construction: Handle (optional): Steel Welded Fixed-position handle located at the ideal pushpoint height Attaching the Control Unit to an Infusion Stand Follow the mounting instructions below to ensure the Control Unit is securely attached to the infusion stand. 1. Select a position to attach the Control Unit on the infusion stand. Ensure: 37

42 Using an Infusion Stand or EKOS CU 4.0 Cart The infusion pumps and Control Unit are positioned as low as practical on the pole. Access to the infusion pumps is not blocked when the Control Unit is attached. 2. Place the pole inside the mounting bracket that is located on the back of the Control Unit (see Figure 31). Figure 31. Pole Inside Bracket 3. Turn the knob clockwise until it is tight (see Figure 32). Figure 32. Turn Knob 4. Ensure the Control Unit is securely attached to the pole and cannot fall off the stand (see Figure 33). 38

43 Transporting the Patient and Control Unit Figure 33. Secure Transporting the Patient and Control Unit 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. 1. Unplug AC power cord from the wall outlet. Note: The Control Unit will automatically switch to battery power and continue to provide ultrasound therapy, if the battery is adequately charged. If the battery is not adequately charged ultrasound will stop and the Control Unit will turn OFF. 2. Secure the housing end of the Connector Interface Cable near the patient to prevent the EkoSonic Device from dislodging. 3. Secure the power cord. 4. Use the carrying handle, the EKOS CU 4.0 Cart or an infusion stand to transport the Control Unit with the patient. Ensure the Control Unit is securely attached to the EKOS CU 4.0 Cart or stand. Transport by holding the pole in the middle or using the provided handle if available to ensure the best control. Do not allow the EKOS CU 4.0 Cart or infusion stand to tip. 39

44 Maintaining the Control Unit Secure patient cables to prevent disconnection during transport. Take care not to trip on the power cord or Connector Interface Cable. 5. When the transport is complete, place the Control Unit on a table near the patient. If using the EKOS CU 4.0 Cart or an infusion stand, ensure the Control Unit is securely attached. 6. Plug the Control Unit into a hospital-grade outlet and, if it is not already turned ON, press the Power button. Note: Press the Start button if ultrasound was stopped or paused during transport and needs to be restarted. Maintaining the Control Unit Cleaning the Control Unit 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! 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. 40

45 Maintaining the Control Unit 3. Disconnect the power cord and Connector Interface Cable(s) from the Control Unit. 4. Wipe the Control Unit and cables with: o An approved cleaning and disinfection hospital wipe or o A mild cleaning solution applied with a damp soft cloth followed by application of a disinfection solution Note: Carefully clean the connector ports. Do not use excessive amounts of cleaning fluids. See table below for example cleaning and disinfection products. Solution Up to 90% isopropyl alcohol Example Product 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 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 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. Note: For more information about storage and operating specifications see Specifications Section. Place Control Unit on a flat surface or attached to an EKOS custom stand, or infusion stand, close to a wall outlet. 2. To maintain a fully charged battery, always connect the Control Unit to a hospital-grade outlet when not in use. 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. 41

46 System Information 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. Disposal The Control Unit and the Connector Interface Cable contain materials that must be disposed of in accordance with environmental protection requirements. Do not dispose of the Control Unit or the Connector Interface Cable as unsorted municipal waste. Please observe all national and local regulations. In accordance with WEEE requirements, before disposing of the Control Unit or the Connector Interface Cable, contact EKOS Corporation for recovery and recycling instructions. System Information This section describes how to view information for the Control Unit, the Connector Interface Cable and the EkoSonic Device. To access the system information, press the Information tab on the display (see Figure 34). Figure 34. System Information Screen 42

47 Power Graph Item Control Unit Software Version Description Serial number for Control Unit Version number for Software Indication of Channel A or B CIC Serial # Ultrasound Serial # Catheter Serial # Ultrasound Zone Catheter Zone Serial number for the Connector Interface Cable Serial number for the Ultrasonic Core Serial number for the Infusion Catheter Ultrasound treatment zone (cm) Infusion Catheter treatment zone (cm) Ultrasonic Core with 5 transducer groups present and active. Displayed for each catheter. Note: number is dimmed if the transducer group is inactive and number is not displayed if the transducer group in not present. Power Graph The Control Unit monitors and presents a historical graph of the ultrasound power delivered to the EkoSonic Device(s). The percentage of the maximum average power actually delivered by each of the two channels, is plotted over time on the power graph. 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. Reading the Power Graph 1. To view the power graph, press the Graph tab on the display (see Figure 35). 43

48 Power Graph Figure 35. Power Graph Menu Tab 2. The power graph displays the power information for each channel with a 6, 12 or 24 hour time scale. As runtime increases the power graph will automatically update to the most appropriate time scale. 3. The percentage of the maximum average power is plotted in the graph. 4. The graph and power data will be displayed as zero if the therapy is stopped for any reason (i.e. stop button pressed, cables disconnected, channel made inactive). See the figures below for examples of a power graphs. 5. The power graph shows the total runtime for the channel, not for the device. If possible, always reconnect devices to the same channels they started on. If two devices are switched from one channel to another, the runtime will reflect the total amount of time that specific channel delivered therapy regardless of the device currently connected. Screen Layout Power Graph Power Graph information is provided for each channel independently showing percent of the maximum average power for the duration of the therapy. Additionally, the current state of the device is shown by the colored channel icon (see Figure 36 and the table below). Menu Tabs Channel A Power Information Channel B Power Information Figure 36. Screen Layout Power Graph Item Description Channel label (A and B): 44

49 Power Graph Item Description Green icon indicates ultrasound is ready to start or currently running. Yellow icon indicates further steps are required to start the ultrasound. Red icon indicates there is an error detected and ultrasound is not running. Black icon indicates the channel is not active. Percentage of the maximum average power currently being delivered. Note: 0% indicates ultrasound is NOT currently being delivered. Channel A power is plotted with a solid line. Channel B power is plotted with a dashed line. Example Power Graphs The power graph screen (Figure 37) shows an example of what is displayed for two devices using two channels. One device is connected to channel A and one device is connected to channel B. Ultrasound therapy has been running for approximately 13.5 hours continuously for both devices and is currently on as indicated by the green channel icons and the 63% and 67% power levels. The average power for channel A has stayed between 50% to 65% during the runtime. This is indicated by the solid white line. The average power for channel B has been slightly higher between 55% to 75%. This is indicated by the dashed white line. Figure 37. Example - Two Channel Power Graph 45

50 Power Graph The next power graph screen (Figure 38) shows an example of what is displayed for two channels when one device is replaced during therapy. For example, one device is connected to channel A and one device is connected to channel B. Ultrasound therapy was running for approximately 15.5 hours continuously for both devices, then the device connected to channel B was replaced with a new device. The new device was connected to channel B on the Control Unit and ultrasound therapy was restarted. Figure 38. Example - Two Channel Power Graph, Device Changed Note: If therapy is stopped for both devices and the devices disconnected from the Control Unit, it is important to reconnect the devices to the same channel therapy was started on. If two devices are switched from one channel to another, the runtime will reflect the total amount of time that specific channel delivered therapy regardless of the device currently connected. Snapshot Every time the Control Unit is turned off and then back on (e.g., turning off for patient transport) a snapshot of the last power graph data will appear on the power graph screen until therapy is started. To access the snapshot, turn the Control Unit off and then back on. Then, press the Power Graph tab on the display. The power graph screen (Figure 39) shows an example of a snapshot power graph. In this example, the label snapshot appears across the graph and both channels have black icons indicating the channels are ready for ultrasound to start. Note: It is not possible to download or print the snapshot. Also, upon starting therapy the snapshot is cleared and active graph data is displayed. 46

51 System Configurations Figure 39. Example - Snapshot Power Graph System Configurations This section describes how to select audible alert tone volume, screen brightness and language on the Control Unit. 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 being missed resulting in delay of ultrasound therapy. To access the system settings, press the Settings tab on the display (see Figure 40). Figure 40. Settings Menu Screen 47

52 System Configurations Audible Alert Volume 1. To increase the volume, tap the right volume symbol until the desired volume is achieved. 2. To lower the volume, tap the left volume symbol until the desired volume is achieved. Note: The minimum setting reduces the volume but does not silence the tone. Screen Brightness 1. To increase the brightness, tap the right circle until the desired brightness is achieved. 2. To lower the brightness, tap the left circle until the desired brightness is achieved. Note: The minimum setting reduces the brightness but does not completely darken the display. Selecting Language 1. To view the list of available languages, press the Select button. 2. From the list of languages, tap the desired language to highlight the selected language (see Figure 41). If the desired language is not visible on the screen, use the blue arrow buttons to navigate to other available languages. Note: Pressing Cancel returns to the main settings menu without changing the current language setting. Figure 41. Language Selection Screen 48

53 Troubleshooting 3. Press Apply to confirm selection and restart the Control Unit (see Figure 42). Note: Pressing Cancel returns to the previous menu and displays the list of available languages. Figure 42. Language Confirmation Screen Troubleshooting The Control Unit provides system errors, channel errors and channel messages to communicate status information. Descriptions of these errors/messages and troubleshooting steps are provided in this section. System Errors A system error affects both channels and stops ultrasound therapy on both channels. System errors are related to system failures, control unit temperature conditions and device cross connection errors. When a system error occurs, an error message with an alert icon displays and an audible tone sounds. Read the message and follow the instructions to attempt to correct the error. Press the Audio Pause button on the Control Unit to silence the alert tone for 5 minutes. When the tone is silenced the alert icon on the display is crossed out. If the issue cannot be resolved by following the onscreen instructions, note the error code in parentheses at the end of the message and contact your local EKOS representative or call Note: In the event that the Control Unit is not operational and ultrasound therapy has stopped, infusion of the solutions will not be interrupted. See Figure 43 and Figure 44 for examples of system error messages: 49

54 Troubleshooting Figure 43. Connection Error Screen Figure 44. Temperature Error Screen System errors that may occur and the steps to take are provided in the table below. Message Description Error Code Possible Cause Troubleshooting Step Unrecoverable Control Unit error. E007 System failure. Contact your local EKOS representative or call Critically low battery. E003 Control Unit is not connected to AC power and remaining battery charge is 5% or less. Control Unit will automatically shut down in 3 minutes. Connect the Control Unit to AC power. Battery/charge error (AC not connected). E008 Control Unit is not connected to AC power and an error with the battery has occurred. Control Unit will automatically shut down in 3 minutes. Connect the Control Unit to AC power. Control Unit is too hot. E004 Control Unit internal temperature exceeds the maximum operating temperature. 1. Ensure the blue cooling vents under the handle are not obstructed. 2. Wait for the Control Unit to cool. 50

55 Troubleshooting Message Description Error Code Possible Cause Troubleshooting Step 3. When the message disappears, resume ultrasound. Control Unit is too cold. E005 Control Unit internal temperature has fallen below the operating temperature. 1. Place the Control Unit in a warmer environment. 2. Wait for the Control Unit to warm to room temperature. 3. When the message disappears, resume ultrasound. Device cables are crossed. E006 Device cables are cross connected between two different Connector Interface Cables. 1. Disconnect all device connectors and reconnect, ensuring that the Infusion Catheter and the Ultrasonic Core from a single EkoSonic Device are connected to one Connector Interface Cable. 2. Press Start to begin ultrasound. Channel Errors A channel error affects one specific channel and stops ultrasound therapy to the device associated with that channel. The channel that does not have a channel error will not be interrupted or affected by the error. Channel errors are related to channel errors, device temperature errors, cable errors and connection errors. Channel errors can occur on both channels at the same time. When a channel error occurs, read the message and follow the instructions to attempt to correct the error. If the issue cannot be resolved by following the onscreen instructions, note the error code in parentheses at the end of the message and contact your local EKOS representative or call Note: In the event that a specific channel is not operating and ultrasound therapy cannot be delivered, infusion of the solutions will not be interrupted. See Figure 45 and Figure 46 below for examples of channel error messages: 51

56 Troubleshooting Figure 45. Channel A Connection Error Figure 46. Channel B Connection Error Channel errors that may occur and the troubleshooting steps to take are provided in the table below. Message Description Error Code Possible Cause Troubleshooting Step Check the catheter connector. E300 E309 E310 E312 E322 Poor connection of the Infusion Catheter. Infusion Catheter Connector is wet at the connection site. 1. Disconnect the Infusion Catheter. 2. Inspect for fluid or damage to the pins. 3. Dry the Infusion Catheter connector, if necessary. 4. Reconnect the Infusion Catheter and ensure the connection is secure. 5. Resume ultrasound. Please contact EKOS Help Line. E301 E303 E316 E317 E318 E319 E323 E324 E325 E326 E327 E328 E329 E330 Channel error. Contact your local EKOS representative or call

57 Troubleshooting Message Description Error Code Possible Cause Troubleshooting Step Check the Ultrasound connector. E302 E320 Poor connection of the Ultrasonic Core. Ultrasonic Core Connector is wet at the connection site. 1. Disconnect the Ultrasonic Core. 2. Inspect for fluid or damage of the pins. 3. Dry the Ultrasonic Core connector, if necessary. 4. Reconnect the Ultrasonic Core and ensure the connection is secure. 5. Resume ultrasound. The Infusion Catheter and Ultrasonic Core are not compatible. E304 The Infusion Catheter and Ultrasonic Core connected to the Control Unit are not compatible (either catheter zone length and ultrasound zone length or working length). Notify the physician. Ensure the Ultrasonic Core is fully inserted in the catheter. E314 The Ultrasonic Core is not fully inserted in the Infusion Catheter while ultrasound is running. Ensure the Ultrasonic Core is fully inserted in the Infusion Catheter. Resume ultrasound. Check the Connector Interface Cable connection to the Control Unit. E306 Connector Interface Cable is disconnected from the Control Unit while ultrasound is running. Ensure the Connector Interface Cable is securely connected to the Control Unit. Replace the Connector Interface Cable. E307 E315 E321 Defective Connector Interface Cable. Replace Connector Interface Cable, or Contact your local EKOS representative or call

58 Troubleshooting Message Description Error Code Possible Cause Troubleshooting Step Check the device connectors. E311 Poor connection of the Infusion Catheter and Ultrasonic Core. Infusion Catheter and Ultrasonic Core Connectors are wet at the connection site. 1. Disconnect the Infusion Catheter and Ultrasonic Core from the Connector Interface Cable. 2. Inspect for fluid or damage to the pins. 3. Dry the Infusion Catheter and Ultrasonic Core connectors, if necessary. 4. Reconnect the Infusion Catheter and Ultrasonic Core and ensure the connections are secure. 5. Resume ultrasound therapy. Incompatibility of CIC E331 The Connector Interface Cable is not compatible with the Infusion Catheter, Ultrasonic Core, or both. Replace the Connector Interface Cable with one compatible with the Infusion Catheter and Ultrasonic Core. The same error has occurred three times. n/a Control Unit has detected the same error three times in a row. Contact your local EKOS representative or call Channel Messages A channel message is specific to a particular channel and indicates a task needs to be completed for the Control Unit to provide ultrasound therapy to that channel. The message may also ask the operator to confirm a particular action that was initiated by the operator. It does not indicate that an error or failure has occurred. The channel that does not have a channel message will not be interrupted or affected by the message. Messages occur when a cable needs to be connected, when ultrasound therapy needs to be started or when a confirmation is needed. Channel messages can occur for both channels at the same time. When a channel message occurs, read the message and follow the instructions for troubleshooting steps to take. See Figure 47 and Figure 48 below for examples of a channel message: 54

59 Symbols and Indicators Figure 47. Channel A Message Figure 48. Channel A and B Messages Descriptions of some of the channel messages are: Press Start to begin ultrasound. Plug the interface cable into the control unit. Plug the device connectors into the interface cable. Plug the ultrasound connector into the interface cable. Plug the catheter connector in the interface cable. Press Apply to accept the new language and automatically restart control unit, or press Cancel to keep the current language. Symbols and Indicators The following symbols and indicators appear in these instructions, on the Control Unit, or on its components (e.g., Connector Interface Cable). Symbol 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. 55

60 Symbols and Indicators Symbol Description 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. Steady green indicates Control Unit is connected to AC power and battery is fully charged. Steady yellow indicated Control Unit is connected to AC power and battery is charging. (Blinking) Blinking red (once per second) indicates Control Unit is connected to AC power and has a battery error. Blinking red (once every 10 seconds) indicates Control Unit is not connected to AC and reminds to plug into AC power. (Charge is greater than 30%.) Blinking red (once every 10 seconds) and an audible alert indicates Control Unit is not connected to AC and the battery has reached a low charge state and reminds to plug into AC power immediately. (Charge is between 20% and 30%.) Ultrasound Start Button: Starts energy transmission for a specific channel when pressed. Ultrasound Stop Button: Stops energy transmission for a specific channel when pressed. Channel A: Channel icon may be green, yellow, red, or black on the display/touchscreen. The label for the hard buttons is always gray. Channel B: Channel icon may be green, yellow, red, or black on the display/touchscreen. The label for the hard buttons is always gray. Home Tab: Displays cable connection, system instructions, and ultrasound runtime information for each channel. 56

61 Symbols and Indicators Symbol Description 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: Displays a configuration menu for setting audible alert volume, screen brightness and language. Connected to AC power and battery is charging. Connected to AC power and battery is fully charged. Battery charge remaining (76% - 100%). Battery charge remaining (51% - 75%). Battery charge remaining (26% - 50%). Battery charge remaining (16%-25%). Battery charge remaining (0% - 15%). 57

62 Symbols and Indicators Symbol Description Defective battery. Contact your local EKOS representative or call Disables channel when pressed. Disable button may be green, yellow or red. 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. Ultrasound therapy is ON. When audio alert tone are on, the alert icon displays. When the audio alert tone are silenced, the alert icon is crossed-out indicating audio is silenced. Decrease screen brightness. Increase screen brightness. Decrease audible tone. Increase audible tone. 58

63 Symbols and Indicators Symbol Description Connector Interface Cable: Used to connect the Infusion Catheter and Ultrasonic Core to the Control Unit. Infusion Catheter: The device Infusion Catheter connects to the Connector Interface Cable. Ultrasonic Core: The device Ultrasonic Core connects to the Connector Interface Cable. CE Mark: The equipment confirms 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. Authorized representative in the European Community. Manufactured on: Equipment was manufactured during the listed year. Symbol for Electro-static Discharge (ESD) sensitive equipment: Equipment is resistant to ESD as required by BS EN However, parts marked with this symbol could be damaged by direct application of electrical discharge. The USB port is for use only by, or at the instruction of, authorized EKOS personnel for downloading procedure log files or uploading new software. When connecting to this port all personnel should first touch the metal housing of the Control Unit chassis with their hand to minimize any potential ESD before plugging in the USB device. Consult Instructions for Use symbol. It is important that all persons using the Control Unit read and understand all the information contained in these instructions prior to use. 59

64 Symbols and Indicators Symbol Description European Directive 2012/19/EU regarding Waste Electrical and Electronic Equipment (WEEE) applies to this device. Canadian Standards Association Certification for the United States. Equipotential Terminal The terminal marked with this symbol is the equipotential terminal. It can be connected to a locally available external equipotential line to prevent danger caused by the difference in the potentials between this device and the other devices. Equipotential Terminal The terminal marked with this symbol is the equipotential terminal. It can be connected to a locally available external equipotential line to prevent danger caused by the difference in the potentials between this device and the other devices. IPX2 Ingress Protection Rating for Control Unit IPX4 Ingress Protection Rating for Connector Interface Cable Symbol for Defibrillator-Proof (Type CF) Equipment: This equipment provides a degree of protection against electrical shock to Type CF as defined in BS EN This equipment has a Type CF applied part capable of withstanding the effects of defibrillator discharge and it meets the leakage current requirements for cardiac intervention. Non-Ionizing Radiation Symbol: Electromagnetic interference may occur in the vicinity of equipment marked with this symbol. 60