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Product Safety Information


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

Evident Vascular® Guidance System

Intended Use

The Evident Vascular® Guidance System (EVGS) is intended for ultrasound examination of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

The Evident® Peripheral Imaging Catheters generate ultrasound images and are intended for ultrasound examination of peripheral vascular pathology only. The recommended use of each of these catheters may vary depending on the size and type of catheter. Refer to the Instructions for Use for all Evident Peripheral Imaging Catheters for additional information on recommended use. 

Contraindications

Use of the Evident Vascular Guidance System is contraindicated in the presence of conditions that create unacceptable risk during catheterization. It is not to be used in coronary arteries.

Possible Adverse Events

The use of the Evident Peripheral Imaging Catheter – or any percutaneous intravascular catheter – could result in adverse reactions; the following complications may occur as a consequence of intravascular examination:

  • Myocardial infarction
  • Vessel occlusion
  • Vessel dissection
  • Perforation, rupture, or injury
  • Restenosis
  • Hemorrhage or hematoma
  • Drug reactions
  • Allergic reaction to contrast medium
  • Hypotension/hypertension
  • Infection/sepsis
  • Vessel spasm
  • Arteriovenous fistula
  • Embolism
  • Entry puncture site bleeding
  • Vascular wall injury
  • Vessel thrombosis
  • Pseudoaneurysm (at site of catheter insertion)
  • Renal insufficiency/failure
  • Vessel aneurysm
  • Vessel trauma requiring surgical repair or intervention
  • Additional surgical intervention
  • Death 

Warnings and Precautions

General Safety Warnings

  • WARNING: To avoid electrical shock, do not remove any panels or covers. In the event of malfunction or system damage, power down the Guidance System, unplug from the power receptable and contact Evident® Technical Support Services.
  • WARNING: Do not modify this equipment. Any changes or modifications not expressly approved by Evident Vascular, Inc. could result in a hazard to the patient or user and possibly void the user’s authority to operate this equipment under FCC regulations. 
  • WARNING: If you suspect malfunction or system damage, turn the system off, unplug the system from the power receptacle, and contact a qualified service person and Evident Technical Support Services.

Electrical Safety Warnings

  • WARNING: The system must be properly grounded to avoid electrical shock. Connect only to power supply mains with protective earth. 
  • WARNING: Removing or defeating the protective earth conductor presents a risk of electric shock and is prohibited.
  • WARNING: Do not connect multiple socket–outlets or extension cords to the system. This may exceed safety limits of the system.
  • WARNING: To prevent fire or shock hazard, do not expose the system to moisture or rain. Use a protective cover during transport in wet conditions. 
  • WARNING: If moisture enters the system, allow it to dry thoroughly before plugging the AC power cord into an electrical outlet.
  • WARNING: If the Mains circuit breaker interrupts power to the system repeatedly, turn the system off, unplug it, and contact a qualified service person and Evident Technical Support Services.
  • WARNING: To prevent compromising patient isolation, operators must not simultaneously touch the patient/catheter/guidewire and any part of the Mobile Cart, Workstation or connector interface.

EMC and Wireless Safety Warnings

  • WARNING: Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC). Portable and mobile Radio Frequency (RF) communications equipment can affect the performance of the system. 
  • WARNING: See Compliance (Chapter 24) for the recommended separation distances between RF communications equipment and the system.
  • WARNING: Portable RF communications equipment (including antenna cables and external antennas) should be at least 30 cm (12 in) from any part of the System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 
  • WARNING: Maintain a minimum separation of 20 cm (8 in.) between the wireless transmitter and the human body during operation to comply with FCC exposure limits.
  • WARNING: Operation of this wireless interface is restricted to healthcare facilities. Use outside of this environment may increase interference risk with other devices.
  • WARNING: Wireless coexistence has been validated for healthcare environments per ANSI C63.27. Use in home or residential settings has not been evaluated.
  • WARNING: The emissions characteristics make the system suitable for industrial and hospital use. Residential use may require mitigation measures. 
  • WARNING: Electrical Fast Transients on the AC line can result in a suspension of operation. If this occurs, turn the system off and back on to resume operations.

Environmental Hazards Warnings

  • WARNING: An explosion risk may exist in areas with high concentrations of flammable anesthetics or cleaning agents. The probability of occurrence of the ignition of such anesthetic mixtures depends upon their concentration, the appropriate minimum ignition energy, the presence of high surface temperatures, and potential sparking. 
  • WARNING: Sparks from switches, connectors, fuses, or over-current releases can ignite such mixtures. 
  • WARNING: Do not power on the workstation in elevated atmospheric concentrations of flammable agents. If the system is already running, do not power off. 
  • WARNING: This device is not intended for use in oxygen-rich environments.

Sterility Warning

  • WARNING: Drape any part of the Evident Vascular Guidance System or components that may extend into the sterile field or that interacts with a sterile user.

System User and Compatibility Warnings

  • WARNING: The system can only be used with Evident® Peripheral Imaging Catheters and accessories. 

Mechanical Safety and Handling Warnings

  • WARNING: Avoid rolling the Mobile Cart over objects to prevent tipping and damage to the system.
  • WARNING: Do not push the Mobile Cart at the neck- use the handles provided.
  • WARNING: Do not push the Mobile Cart on unsafe slopes.
  • WARNING: Do not put the Workstation on its side.
  • WARNING: Position the Mobile Cart and power cord to minimize tripping hazards.
  • WARNING: Keep fingers away from moving parts and joints on the Articulating Tablet Mount as well as the Mobile Cart.
  • WARNING: Remove the Tablet from the Articulating Tablet Mount before clamping and unclamping it from the bedrail or storing the Articulating Tablet Mount.
  • WARNING: When keeping the CIM on the Mobile Cart instead of a bed rail, ensure casters are locked to avoid inadvertent removal of imaging catheter from patient.

Operational Precautions

  • CAUTION: Stop imaging and withdraw the Evident Peripheral Imaging Catheter from the patient prior to defibrillation. 
  • CAUTION: Ensure catheter latch is engaged in the CIM receptacle before imaging.
  • CAUTION: Do not disconnect the Evident Peripheral Imaging Catheter while imaging. 
  • CAUTION: Do not share user login credentials. All logins are traceable and part of the medical record.
  • CAUTION: Installation of unauthorized software is prohibited and may impair performance or security.
  • CAUTION: If you archive, the case will be deleted after 1 month. If not, the system will prompt you to archive when disk space falls below 20% of maximum capacity. 
  • CAUTION: The system must be shut down using the application software controls before switching off the main AC power switch. Pressing the main AC power switch or the tablet power button during recording may corrupt data. Wait at least 10 seconds before turning the system back ON. 

Cleaning Precautions

  • CAUTION: Never spray or otherwise apply any cleaner directly into the openings or seams of the Evident Vascular Guidance System or components. Always apply the cleaner to a soft cloth instead. 
  • CAUTION: Do not use harsh chemicals or cleaning solvents to clean the Evident Vascular Guidance System or its components. Never use acetone to clean the Evident Vascular Guidance System or its components. 
  • CAUTION: No portion of the Evident Vascular Guidance System or its components should be immersed in water or other fluids.

Electrical and Environmental Safety Precautions

  • CAUTION: The product and its accessories are rated IPX0 – No special protection provided.
  • CAUTION: No batteries are user replaceable. 
  • CAUTION: Do not block ventilation fans on the CIM or Workstation.
  • CAUTION: To achieve proper grounding reliability, the power plug must be fully inserted into a Hospital Grade receptacle. If you are unsure, seek qualified technical assistance. 
  • CAUTION: Avoid sudden temperature changes to prevent condensation. After exposure to cold, allow time for acclimation before plugging in. 
  • CAUTION: The Workstation should not be stacked with other equipment.
  • CAUTION: Do not to position the equipment so that it is difficult to access or operate the AC inlet (or plug) at the rear of the equipment which is the equipment’s disconnection device.

Wireless and EMC Precautions

  • CAUTION: Never use the system or accessories that you suspect may have been damaged.
  • CAUTION: In case of abnormal system operation, follow shutdown and startup procedures in the User Manual. 
  • CAUTION: Do not roll equipment over the System Cable, AC power cord, ethernet cable or other connected cabling.
  • CAUTION: Do not use excessive force when disconnecting the System Cable.
  • CAUTION: The CIM should not be placed below an IV pole where liquids may drip into the catheter receptacle and cause damage.
  • CAUTION: Ensure that Tablet is fully latched into the Tablet Mount before operating.
  • CAUTION: Use only cables and accessories approved by Evident Vascular, Inc. (e.g., power cords, adapters, ethernet/ video cables). Otherwise, degradation of the performance of this equipment could result.

Declarations for Electromagnetic Compatibility (EMC) and Associated Risks

The Evident Vascular® Guidance System complies with the requirements of IEC 60601-1-2:2020. The system was tested to the following standards. The system is designed for use in a clinic/hospital non-protected electromagnetic environment. It should not be located where there are any active HF Surgical, magnetic resonance, electrocautery, or diathermy devices.

Evident® 14 Peripheral Imaging Catheter

Intended Use

The Evident 14 Peripheral Imaging Catheter is intended for ultrasound examination of peripheral vascular pathology only. lntravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Contraindications

This product is contraindicated in the presence of conditions that create unacceptable risk during catheterization. It is not to be used in the coronary arteries.

Adverse Events

The following potential risks or discomforts may be associated with vascular imaging procedures. These risks include those associated with all catheterization procedures. The frequency and severity of these adverse events can vary, and may necessitate additional medical intervention, including surgery. The physician should communicate all foreseeable risks to the patient.

  • Myocardial infarction
  • Vessel occlusion
  • Vessel dissection
  • Perforation, rupture, or injury
  • Restenosis
  • Hemorrhage or hematoma
  • Drug reactions
  • Allergic reaction to contrast medium
  • Hypotension/hypertension
  • Infection/sepsis
  • Vessel spasm
  • Arteriovenous fistula
  • Embolism
  • Entry puncture site bleeding
  • Vascular wall injury
  • Vessel thrombosis
  • Pseudoaneurysm (at site of catheter insertion)
  • Renal insufficiency/failure
  • Vessel aneurysm
  • Vessel trauma requiring surgical repair or intervention
  • Additional surgical intervention
  • Death

Warnings

  • The EV14P imaging catheter should be used only by physicians who are familiar with and properly trained to perform the techniques, as well as the specific approach to be used, in a fully equipped catheterization lab.
  • The catheter is supplied sterile. If the package is opened or damaged, compromising the sterility, discard the product.
  • The catheter is for single-use only. Do not reuse or resterilize.
  • Do not use the catheter for purposes other than those indicated.
  • Use the catheter with the introducer sheath or guide catheter size and guidewire size as indicated on the product label. Failure to do so may result in inability to advance the catheter and/or damage to the catheter.
  • The catheter may not be safe for patients who cannot be properly anticoagulated or who cannot receive anti-platelet or anti-coagulation therapies.
  • The catheter has no user-serviceable parts. Do not attempt to repair or modify any component of the catheter assembly as provided. Modifying the catheter could result in poor image quality or patient complications.
  • The safety and effectiveness of the coated device has not been established, or is unknown, in vascular regions other than those specifically indicated.
  • Failure to abide by the warnings in this labeling might result in damage to the device, which may necessitate intervention or result in serious adverse events.
  • Never advance or withdraw the catheter without direct fluoroscopic visualization, as it might cause vessel injury or patient complications.
  • Do not forcibly advance the catheter if resistance is encountered. The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis. A catheter that is forcibly advanced might cause vessel injury or patient complications. Determine the source of resistance, exercise caution when removing the device and/or other components as a unit, and exchange the device for a new one to complete the procedure when there is resistance or the device does not move freely.
  • Do not advance the catheter along a guidewire that may be passing between one or more stent struts. This could result in stent dislocation, the entrapment of the catheter/guidewire, or separation of the catheter distal tip from the catheter hub.
  • If resistance is met upon withdrawal of the catheter, assess the cause of resistance using fluoroscopy. If necessary, remove both the catheter and guidewire together. If additional imaging is needed, exchange the device for a new one to complete the procedure.
  • Use caution when removing the catheter over the guidewire from a stented vessel to minimize patient risk.

Precautions

  • While inserting the catheter through a hemostasis valve into a guide or sheath, do not turn on imaging until after the catheter distal end is in the sheath or guide lumen.
  • If inserting the catheter through a rotating hemostasis valve, tighten the valve around the catheter just enough to prevent fluid or blood leakage. Excessive tightening of the valve may cause image distortion and/or catheter damage.
  • Before use, carefully inspect the catheter for physical damage. Do not use a damaged catheter.
  • Protect the catheter distal tip from impact and excessive force.
  • Protect the electrical connections from exposure to fluid.
  • During use, ensure that the placement of the catheter does not preclude blood flow through the vessel.
  • Do not advance the catheter without guidewire support, as it can cause difficulty in reaching the intended region or may cause the catheter distal tip to kink.
  • Do not advance the catheter around a tight bend without sheath or guide catheter support, as it can cause difficulty in reaching the intended region or may cause the catheter distal tip to kink.
  • When inserting the guidewire, both the catheter and the guidewire must be straight with no bends or kinks. Bends or kinks might damage the guidewire lumen.
  • During the procedure, provide appropriate anticoagulation to the patient, as needed.
  • After use, dispose of the catheter and packaging according to institutional, local, and state policies.

MRI Safety Information

The catheter is MR Unsafe and should remain outside an MR scanner room.

Evident® 35 Peripheral Imaging Catheter

Intended Use

The Evident 35 Peripheral Imaging Catheter is intended for ultrasound examination of peripheral vascular pathology only. lntravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Contraindications

This product is contraindicated in the presence of conditions that create unacceptable risk during catheterization. It is not to be used in the coronary arteries.

Adverse Events

The following potential risks or discomforts may be associated with vascular imaging procedures. These risks include those associated with all catheterization procedures. The frequency and severity of these adverse events can vary, and may necessitate additional medical intervention, including surgery.

The physician should communicate all foreseeable risks to the patient.

  • Myocardial infarction
  • Vessel occlusion
  • Vessel dissection
  • Perforation, rupture, or injury
  • Restenosis
  • Hemorrhage or hematoma
  • Drug reactions
  • Allergic reaction to contrast medium
  • Hypotension/hypertension
  • Infection/sepsis
  • Vessel spasm
  • Arteriovenous fistula
  • Embolism
  • Entry puncture site bleeding
  • Vascular wall injury
  • Vessel thrombosis
  • Pseudoaneurysm (at site of catheter insertion)
  • Renal insufficiency/failure
  • Vessel aneurysm
  • Vessel trauma requiring surgical repair or intervention
  • Additional surgical intervention
  • Death

Warnings

  • The EV35P imaging catheter should be used only by physicians who are familiar with and properly trained to perform the techniques, as well as the specific approach to be used, in a fully equipped catheterization lab.
  • The catheter is supplied sterile. If the package is opened or damaged, compromising the sterility, discard the product.
  • The catheter is for single-use only. Do not reuse or resterilize.
  • Do not use the catheter for purposes other than those indicated.
  • Use the catheter with the introducer sheath size and guidewire size as indicated on the product label. Failure to do so may result in inability to advance the catheter and/or damage to the catheter.
  • The catheter may not be safe for patients who cannot be properly anticoagulated or who cannot receive anti-platelet or anti-coagulation therapies.
  • The catheter has no user-serviceable parts. Do not attempt to repair or modify any component of the catheter assembly as provided. Modifying the catheter could result in poor image quality or patient complications.
  • The safety and effectiveness of the coated device has not been established, or is unknown, in vascular regions other than those specifically indicated.
  • Failure to abide by the warnings in this labeling might result in damage to the device, which may necessitate intervention or result in serious adverse events.
  • Never advance or withdraw the catheter without direct fluoroscopic visualization, as it might cause vessel injury or patient complications.
  • Do not forcibly advance the catheter if resistance is encountered. The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis. A catheter that is forcibly advanced might cause vessel injury or patient complications. Determine the source of resistance, exercise caution when removing the device and/or other components as a unit, and exchange the device for a new one to complete the procedure when there is resistance or the device does not move freely.
  • Do not advance the catheter along a guidewire that may be passing between one or more stent struts. This could result in stent dislocation, the entrapment of the catheter/guidewire, or separation of the catheter distal tip from the catheter hub.
  • If resistance is met upon withdrawal of the catheter, assess the cause of resistance using fluoroscopy. If necessary, remove both the catheter and guidewire together. If additional imaging is needed, exchange the device for a new one to complete the procedure.
  • Use caution when removing the catheter over the guidewire from a stented vessel to minimize patient risk.

Precautions

  • While inserting the catheter through a hemostasis valve into a guide or sheath, do not turn on imaging until after the catheter distal end is in the sheath or guide lumen.
  • If inserting the catheter through a rotating hemostasis valve, tighten the valve around the catheter just enough to prevent fluid or blood leakage. Excessive tightening of the valve may cause image distortion and/or catheter damage.
  • Before use, carefully inspect the catheter for physical damage. Do not use a damaged catheter.
  • Protect the catheter distal tip from impact and excessive force.
  • Protect the electrical connections from exposure to fluid.
  • During use, ensure that the placement of the catheter does not preclude blood flow through the vessel.
  • Do not advance the catheter without guidewire support, as it can cause difficulty in reaching the intended region or may cause the catheter distal tip to kink.
  • Do not advance the catheter around a tight bend without sheath or guide catheter support, as it can cause difficulty in reaching the intended region or may cause the catheter distal tip to kink.
  • When inserting the guidewire, both the catheter and the guidewire must be straight with no bends or kinks. Bends or kinks might damage the guidewire lumen.
  • During the procedure, provide appropriate anticoagulation to the patient, as needed.
  • After use, dispose of the catheter and packaging according to institutional, local, and state policies.

MRI Safety Information

The catheter is MR Unsafe and should remain outside an MR scanner room.