IFU 51958955-01A

Rx Statement

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. 

User Information

The System is a medical device system for use by, or on the order of, a physician. For details on the hardware and software components included in this System, see Device Description below.

 This System supports intravascular ultrasound (IVUS), fractional flow reserve (FFR) and Diastolic hyperemia - Free Ratio (DFR) functionalities.

The IVUS functionality of the System and the IVUS portions of this documentation are intended for in-vivo use only by medical professionals fully qualified to perform invasive ultrasound procedures; however, other personnel properly educated in System usage may use the System and this documentation when patient contact is not involved. It is assumed that all users are fully qualified in proper laboratory procedures and protocols.

The FFR and DFR functionalities of the System and the respective portions of this documentation are intended for use only by medical professionals fully qualified to perform interventional human blood pressure measurement procedures; however, other personnel properly educated in System usage may use the System and this documentation when patient contact is not involved. It is assumed that all users are fully qualified in proper laboratory procedures and protocols.

For information about the intended use, indications for use, contraindications, warnings, cautions, and precautions for compatible Imaging Catheters, pressure guidewires, and System accessories, refer to the Instructions for Use packaged with those devices.

Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

Indications for System Use

The IVUS modality of the System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

FFR and DFR are intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.

Refer to the Catheter Instructions for Use provided with all Boston Scientific Ultrasound Imaging Catheters to determine compatibility with the System. All Ultrasound Imaging Catheters will be referred to as Imaging Catheters throughout the remainder of this User Guide.

The Imaging Catheters generate ultrasound images and are intended for ultrasound examination of vascular and cardiac pathology. Boston Scientific manufactures a wide variety of catheters for different applications. The recommended use of each of these catheters may vary depending on the size and type of the catheter. Please refer to the Imaging Catheter Instructions for Use, packaged with each catheter.

Indications for Auto Pullback Use (IVUS Only)

Automatic Pullback is indicated when the following occurs:

• The physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator.
• The physician/operator wants to make linear distance determinations post-procedurally, which requires the imaging core of a catheter to be pulled back at a known uniform speed.
• Two-dimensional, longitudinal reconstruction of the anatomy is desired.

CONTRAINDICATIONS

The System has no patient alarm functions and should not be used for cardiac monitoring.

Consult the Imaging Catheter, Guidewire, FFR Link, Motordrive Unit, and the Sled Instructions for Use for a complete list of Contraindications, Adverse Events, Warnings and Precautions.

WARNINGS AND PRECAUTIONS

It is not possible for Boston Scientific Corporation (hereafter referred to as “Boston Scientific” or “BSC”), to anticipate every condition and situation in which the System is used. The following warnings and precautions represent typical situations that require special attention. Your knowledge and experience with your specific application and environment must also be taken into consideration in order to help assure safety for personnel.

WARNINGS

Carefully read all instructions prior to use. Observe all indications, contraindications, warnings, and precautions noted in these directions before attempting to use the System.

• The System is intended for use by healthcare professionals only.
• Inappropriate use of the System may lead to patient illness, or injury. Please read this User Guide and the Instructions for Use for the FFR Link, Imaging Catheters, MDU, and pressure guidewires carefully and completely before attempting to use the System.
• The System can only be used with Boston Scientific specified accessories, imaging catheters, pressure guidewires and cables. The use of accessories and cables other than the items provided by Boston Scientific may result in increased emission or decreased immunity of the System. For questions regarding this matter, please contact Boston Scientific for technical assistance.
• No modifications to hardware or software, including installation of third party software, are allowed.
• Provide the System with external Internet connectivity through a secure, trusted network so that it can receive current security policies. Without Internet connectivity, the System will not receive the latest downgrade protections, malware definitions, application whitelisting, firewall rules, exploit-prevention and security-monitoring configurations, or trusted code-signing certificates, which may increase exposure to cybersecurity threats.
• Do not attempt to disassemble any component of the System.
• The System is not sterilized and is not intended for use in the sterile field; however, the Tableside Control component of the system is intended for use in the sterile field where it needs to be properly covered with clear sterile draping during procedures.
• To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth.
• To achieve proper grounding reliability, the power plug must be fully inserted into a receptacle marked “Hospital Grade.” If there is any question of power outlet or power cord integrity, do not proceed. Obtain qualified technical assistance.
• Do not block the power switch or the main system power plug with another device or any other obstacle so the operator is free to easily disconnect the system from AC Mains.
• Connecting electrical equipment to the Multiple Socket Outlet (MSO) effectively leads to creating a Medical Electric (ME) system and the result can be a reduced level of safety (i.e., the MSO is the Isolation Station and the ME system is the AVVIGO+ System).
• Do not place the Isolation Station Transformer on the floor.
• Do not plug components intended to be plugged into the Isolation Station Transformer into a wall outlet. The risk involved with this action could present higher leakage currents to the operator and/or patient.
• If an emergency shutdown is necessary, cut off the main electric supply to the System by switching the power OFF on the Isolation Station.
• Only BSC supplied video cables, video splitters and converters, power cords, and data cables should be used with the system. Use of other cables may result in increased risk of electromagnetic interference.
• Portable Radio Frequency (RF) Communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in) to any part of the System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
• The AVVIGO+ System and FFR Link uses type CF (Cardiac Floating) defibrillator-proof connections with its applied parts. So that the defibrillator-proof function of the AVVIGO+ System and FFR Link is not compromised. Only use the AVVIGO+ System and FFR Link with parts, accessories, applied parts and transducers approved by Boston Scientific.
• Equipment is suitable for hospital environment except for near active high frequency surgical equipment (i.e., electrocautery, diathermy, etc.) and the RF shielded room of medical equipment for magnetic resonance imaging (MRI), where the intensity of electromagnetic disturbances is high.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• The System and/or the external equipment can be damaged if signal levels are not appropriate. If equipment not specifically authorized by Boston Scientific is to be connected, it must meet all applicable electrical safety standards that apply to the System in order to maintain the System’s safety integrity.
• If fuses for the AC Power Isolation Station are to be checked or replaced, disconnect the Isolation Station (or power cord from the System) from the facility’s AC mains before starting, to avoid potential electrical shock.
• Use only fuses complying with IEC 60127 which have high breaking capacity.
• To prevent fire or shock hazard, do not expose the System to moisture or rain. If it is necessary to transport the System through rain, place a protective cover over it. If moisture gets into the instrument, allow it to dry thoroughly before plugging the AC power cord into an electrical outlet.
• Spilling liquids on the System can damage it or cause it to shut down. Never pour any liquid into an opening. This may cause fire or electrical shock.
• In the unlikely event that smoke, abnormal noise, or strange odor is present, immediately cut off the main electric supply to the System by switching the power OFF on the Isolation Station and disconnect all power sources. Report the problem to Boston Scientific Technical Assistance immediately.
• Appropriately position the mobile pole / power cord to minimize tripping hazard.
• Avoid rolling the mobile pole over objects to prevent tipping and possible damage to the system.
• External equipment intended for connection to signal inputs, signal outputs or other connectors shall comply with the relevant product standard (e.g., IEC 60950-1 or IEC 62368-1 for IT-equipment and the IEC 60601-series for Medical Electrical Equipment).In addition, all such combinations – Medical Electrical Systems – shall comply with the safety requirements stated in the general standard IEC 60601-1, edition 3, clause 16. Any equipment not complying with the leakage current requirements in IEC 60601-1 shall be kept outside the patient environment (i.e., at least 1.5 m (4.9 ft) from the patient support or shall be supplied via a separation transformer to reduce the leakage currents).  Any person who connects external equipment to signal inputs, signal outputs or other connectors has formed a Medical Electrical System and is therefore responsible for the system to comply with the requirements. If in doubt, contact qualified BSC medical technician or your local BSC representative.
• During the operation, do not touch the metal part of battery connector / SIP / SOP output on the touchscreen and the patient simultaneously.
• Exercise care when depressing the tablet touchscreen. Depressing the touchscreen too rapidly or too firmly can lead to it operating in an unintended manner.
• The tablet battery used in this device may present a risk of fire or chemical burn if mistreated. Do not disassemble, heat above 50°C, or incinerate.
• Dispose of used tablet battery promptly.
• Fluctuations in AC power (voltage dips or surges), may result in unpredictable behavior of the System and may affect the reliability of diagnostic images or waveforms.
• It is required to configure and run the System diagnostics tests as the first step to establish connectivity to various peripherals and verify successful installation.
• The default Time Gain Compensation (TGC) has been preselected as being appropriate for most imaging circumstances for a specific catheter type. Improper setting of this selection may obscure valuable diagnostic information in the display.
• Care should also be exercised in adjusting all settings to avoid obscuring low-level signals that may have diagnostic value. Improper settings can seriously degrade image quality.
• Improper setting of the Data Dependent Processing (DDP) selections may obscure valuable diagnostic information in the display.
• JPEG compression reduces both the spatial and grayscale quality of the stored image, even at the highest (100 %) setting. This could impact the diagnostic quality of the images. Do not utilize this System setting without approval from your institution.
• The ALA feature has not been evaluated in patients with coronary artery aneurysms or with aneurysmal coronary artery disease like Kawasaki’s disease.
• Inappropriate use of the System may lead to misinterpretation of patient data and subsequent misdiagnosis/mistreatment, potentially leading to injury.
• Do not draw a self-intersecting geometry for an area measurement. The area of geometry reported by the System may not be accurate in that scenario.
• Refer to the Instructions for Use supplied with the specific Imaging Catheter to determine certification for use with the System. If the proper identification of a connected Imaging Catheter is not displayed on the Imaging Display, do not proceed with its use.
• The System employs a floating double insulated patient isolation connection within the System’s Motordrive Unit. This connection is intended for defibrillator-proof direct cardiac application (type CF) and includes circuitry to limit the patient leakage current to the levels specified in ANSI/AAMI ES60601-1, EN 60601-1, and JIS-T-0601-1.
• Prior to initiating and during Automatic Pullback, ensure that the Motordrive/Sled combination is in a stable and level position and will not fall. Failure to do so may jeopardize patient safety.
• Connect the Acquisition Processor’s Ethernet interface only to the supplied AVVIGO+ tablet. Do not connect the Acquisition Processor to a hospital network, the Internet, or any other network infrastructure. Such connections may increase exposure to cybersecurity threats, including unauthorized access, malware, modification of system functions, or loss of system availability. Use only the connection methods and equipment specified in this document.

PRECAUTIONS

• Do not place the Acquisition Processor where it will impede the normal movement of the Patient Table.
• Always adhere to your facility’s personal protective equipment (PPE) precautions and cleaning measures.
• Never use the System and System Accessories that you suspect may have been damaged.
• Always exercise care and caution when operating and handling the System.
• Avoid rolling equipment casters of any size or weight over the cables.
• In case of abnormal System operation, the System may require shutdown and restart to bring it to normal operation. Follow the normal shutdown and startup procedures listed in the Operating Instructions.
• Do not depress the tablet power switch at any time while using the System. Power is controlled by software and the main AC Power Switch. If the tablet power switch is pressed while recording a run, the recorded data may become corrupted and should not be used.
• The System must be shutdown using the application software controls first before switching off the main AC power switch or unplugging the hospital mains power cord. If the main AC power is removed or the tablet power button is pressed while recording a run, the recorded data may become corrupted.
• A failure to follow the security instructions provided in the System Security and Privacy section could result in unauthorized access, malware infections, data breaches, and other disruptions to the System’s security objectives.
• Avoid sudden changes in temperature as condensation can form on the internal parts of the System. If the System has to be moved into a warm location after prolonged exposure to cold temperatures, allow it to acclimate for a minimum of 2 to 3 hours before plugging it into an electrical outlet.
• If you archive, the case will be deleted after 6 months. If you do not archive, the system will prompt the user to archive when the disk space is less than 20 % of the maximum capacity.
• After you select Yes in the Delete Selected Cases Confirmation window, your selected cases are deleted and cannot be recovered.
• The results of an IVUS run using any of the advanced IVUS features are based on a machine learning algorithm. These features rely on human-in-the-loop decision making. Operators must elect to use and edit or review all data outputs. The user has the ultimate discretion on the appropriate actions to take based on the information presented.
• Before attempting to write DICOM files to removable media, make sure that a removable USB is inserted in the tablet.
• External defibrillation or cardioversion can potentially harm the patient or damage the AVVIGO+ System and FFR Link. Consider the following when using a defibrillator:
  • Avoid placing a pad (or paddle) directly over parts and accessories of the AVVIGO+ System and FFR Link.
  • Position the pads (or paddles) as far from the AVVIGO+ System and FFR Link as possible.
  • Set the energy output of external defibrillation equipment as low as clinically acceptable.
• Medical electrical equipment requires special precautions regarding electromagnetic compatibility.
• Use only with BSC supplied external power supplies. Using other power supplies may cause damage to the docking station or monitor.
• The power adapter, charger, and the tablet may become hot during normal use. Allow for proper ventilation around the power adapter, charger, and charging tablet.
• The AC Power Isolation Station is intended to be used only with the System equipment. Do not use any unused outlet on the AC Power Isolation Station for non-BSC equipment.
• Only use your finger to tap to operate the touchscreen. Do not use sharp pointed objects to operate the Touchscreen, as doing this could cause permanent damage to the touchscreen and void the warranty.
• Verify that both latches on the Sled are fully engaged with the Motordrive. If not, apply more pressure to the Motordrive and manually engage the latches. Do not use the Sled if the Motordrive is not properly latched into the receptacle. The Display on the Motordrive will light when the Motordrive is properly mounted in the Sled.
• Ensure that the Imaging Catheter runs in a straight path from the Motordrive to the nose of the Sled. Severe bends in the proximal half of the catheter shaft could affect pullback measurement accuracy and adversely affect image quality.
• When flushing the imaging catheter, DO NOT USE EXCESSIVE PRESSURE!
• If an Imaging Catheter that has not been approved for use with the System is connected, or if an Imaging Catheter is not properly connected, the corresponding Imaging Catheter identification data and Displayed Depth will not be displayed. Imaging will be disabled. Resolve this issue before continuing use.
• Do not let the sterile bag interfere with insertion of the catheter hub in the motordrive.
• Ensure that the Imaging Catheter is carefully inserted through the opening in the Motordrive Sterile Bag, without catching any part of the Bag between the Imaging Catheter and the Motordrive.
• If you have difficulty inserting the Imaging Catheter hub into the Motordrive, remove the Catheter hub and press the Imaging button. After 1 s, the Motordrive shaft will stop spinning; at this point, you can reinsert the catheter hub.
• Never attempt to connect or disconnect an Imaging Catheter to the Motordrive while it is running, or damage to the Imaging Catheter or Motordrive may occur.
• Do not attempt to manually move the Motordrive in the Sled once it is installed in a Sled without first depressing the release lever, or damage to the Sled and/or Motordrive may occur.
• Do not allow anything to obstruct the linear motion pathway of the Motordrive on the Sled, as this will interfere with proper pullback motion.
• If the hemostasis valve seal is tightened excessively, the rotating imaging core within the Imaging Catheter may become pinched, which can damage it, or cause image artifacts.
• The System can be susceptible to ESD (Electrostatic Discharge) and EFT (Electrical Fast Transients). BSC recommends that all staff involved with the operation of the System be shown the ESD warning symbol, and be informed to avoid touching the connectors labeled with an ESD symbol.
• The System is intended for use in the electromagnetic environment as specified below. The user of the System should ensure that it is only used in such an environment.
• The AC Power Isolation Station Transformer must be plugged into a grounded hospital grade AC power wall outlet.
• The AC Power Isolation Station Transformer is intended to be used only with BSC System equipment. Do not use any outlet on the AC Power Isolation Station Transformer for non-BSC System equipment.
• Other than the fuses on the AC Power Isolation Station Transformer, the System enclosures contain no operator-serviceable components. To avoid electrical shock, do not remove covers. As with any other electrical equipment, always observe care when operating this instrument. Refer servicing to BSC authorized personnel only. Failure to do so may void your warranty or service contract coverage.
• For continued protection against fire hazard, replace fuses only with those listed in this manual and on the manufacturer’s replacement fuse label located on the AC Power Isolation Station. Do not use fuses with higher amp rating than those listed in this document.
• The tablet mobile pole height adjustment operates by pneumatic pressure and will travel upward when the foot pedal is engaged. Ensure that nothing obstructs the upward movement of the pole.
• Avoid prolonged exposure of the display panel to any strong heat source. Wherever possible, the tablet should face away from direct light to reduce glare.
• The anti-glare coating on the Liquid Crystal Display (LCD) panel can be scratched.
• Do not disconnect internal network connections. Inadvertently connecting cables to incorrect ports may lead to internal communication errors of the system or system failures. If in doubt about network configurations, contact BSC Technical Assistance Center or your local BSC representative.

ADVERSE EVENTS

Please consult the Imaging Catheter and Pressure Guidewire Instructions for Use.

ADDITIONAL WARNINGS

• The following addresses are reserved for the System’s internal communications only. Do not assign any of these IP addresses for the tablet’s DICOM communications to avoid safety and security risks. 192.168.1.1 192.168.1.2
• The System is intended for use by healthcare professionals only. This system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orientating or relocating the System or shielding the location.

ADDITIONAL PRECAUTIONS

• The top and bottom surfaces of the power supply enclosure are not intended to be touched while the power supply is in use. While the unit is in use, the top and bottom surfaces of the power supply enclosure may reach temperatures which cause discomfort when touched for more than 1 s. There are no user accessible parts on the top and bottom surface of the power supply. Use only the front panel and rear panel switches, knobs and connectors - which are intended to be used while the power supply is in operation.
• The results of an IVUS run using Automated Lesion Assessment (ALA) are based on a machine learning algorithm. This is a feature that relies on human-in-the-loop decision making. Operators must elect to use and edit or review all data outputs. The user has the ultimate discretion on the appropriate positioning of the lumen and vessel borders. The lumen and vessel borders can be repositioned on the cross-sectional image by selecting the border, using the mouse to reposition the border, and selecting the image again.
• The results of an IVUS run using Side Branch Display are based on a machine learning algorithm. Accuracy may be reduced for smaller side branches (< 1.5 mm) and for pullbacks performed within the Right Coronary Artery (RCA), stented and non-major epicardial vessels. In these situations, side branches may be less consistently detected and may result in missed branches or misidentified locations. The Side Branch Display is designed to support clinicians with identification and labeling of side branches within a physician-in-the-loop workflow, and are not intended to provide diagnostic decisions. Operators must elect to use and edit or review all data outputs. The user has the ultimate discretion on confirming the presence of Side Branch Markers. The user may delete side branches. The user may add additional user defined bookmarks if they identify or require side branch markers to be edited or adjusted.
• The results of an IVUS run using Automated Stent Assessment (ASA) are based on a machine learning algorithm. This feature relies on human-in-the-loop decision making. Operators must elect to use and edit or review all data outputs. The user has the ultimate discretion on the appropriate Proximal and Distal Key Frame Markers. The user can move the Distal and Proximal Key Frame Markers and the Lumen Borders to alter the calculations associated with Stent Assessment. The Relative Stent Expansion (RSE) Percentage is a dynamic display and the user may select either the Proximal or Distal Key Frame Marker as the comparative reference with the UI.
• The results of an IVUS run using IVUSConnect are generated by a machine learning algorithm. Accuracy may be reduced for smaller side branches (< 1.5 mm) and for pullbacks performed within the Right Coronary Artery (RCA), stented and non-major epicardial vessels. In these situations, side branches may be less consistently detected and may result in missed branches or misidentified locations. IVUSConnect is designed to support clinicians with identification and labeling of side branches within a physician-in-the-loop workflow and is not intended to provide diagnostic decisions. Operators must elect to use and edit or review all data outputs. The user has the ultimate discretion and responsibility to review and adjust data within the Co-Registration display. The user must select an appropriate still-frame angiogram image of adequate quality and appropriate projection angle to create the reference angiogram frame used to generate the co-registered IVUS and angiographic image. The user must manually assign IVUS run start and stop points based on review of the angiogram and positioning of the guide catheter and IVUS catheter prior to IVUS pullback. The user is prompted to review and align and confirm the IVUS data to the angiogram based on fiducial points corresponding to side branches. To ensure proper alignment, fiducial points should be reviewed and, as determined necessary by the operator, adjusted or deleted to align the position of side branches within the IVUS run to their corresponding locations on the angiogram.
• The System must be shutdown using the application software controls. Avoid using the Power Button (“hold 4 + seconds” feature) to turn off the tablet — this form of hardware shutdown is intended to be a means of recovery from lockups, and not as normal operation. If the tablet power button is pressed while recording a run, the recorded data may become corrupted.
• Once YES is selected, the case(s) cannot be recovered.
• Other than the fuses on the AC Power Isolation Station, the System enclosures contain no operator-serviceable components. To avoid electrical shock, do not remove covers. As with any other electrical equipment, always observe care when operating this instrument. Refer servicing to BSC authorized personnel only. Failure to do so may void your warranty or service contract coverage.
• For continued protection against fire hazard, replace fuses only with those listed in this manual and on the manufacturer’s replacement fuse label located on the AC Power Isolation Station. Do not use fuses with higher amp rating than those listed in this document.