IMPORTANT SAFETY INFORMATION
OPTIS™ Imaging Systems and Software
INDICATIONS
The OPTIS Integrated System and Mobile System with OPTIS Software combined with Dragonfly™ DUO or Dragonfly™ OPTIS™ Imaging Catheter are intended for the imaging of coronary arteries and are indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly DUO or Dragonfly OPTIS Imaging Catheter are intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The OPTIS Integrated System and Mobile System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.
CONTRAINDICATIONS
The OPTIS Integrated System and Mobile System with OPTIS Software are contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include:
- Bacteremia or sepsis
- Major coagulation system abnormalities
- Patients diagnosed with coronary artery spasm
- Patients disqualified for CABG surgery
- Patients disqualified for PTCA
- Severe hemodynamic instability or shock
- Total occlusion
- Large thrombus
- Acute renal failure
NOTE: The systems have no patient alarm functions. Do not use for cardiac monitoring.
WARNINGS
- Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
- Observe all advancement and movement of the Dragonfly Imaging Catheter under fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage.
- Leave the guidewire engaged with the catheter at all times during use. Do not withdraw or advance the guidewire prior to withdrawing the catheter.
- If resistance is encountered during advancement or withdrawal of the Dragonfly Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the catheter and guidewire together.
- The catheter should never be forced into lumens that are narrower than the catheter body or forced through a tight or heavily calcified lesion.
- The catheter should not be advanced through abnormally tortuous anatomy.
- When advancing or retracting a catheter with a minirail tip through a stented vessel, the catheter may engage the stent between the junction of the catheter and guidewire, resulting in entrapment of catheter/guidewire, catheter tip separation, and/or stent dislocation.
- Refer to the contrast media’s instructions-for-use for general warnings and precautions relating to use of the contrast media.
PRECAUTIONS
- Safety and effectiveness have been established for the following patient population: adult patients undergoing non-emergent percutaneous coronary interventions in lesions with reference vessel diameters between 2.0 to 3.5 mm, which were not located in the left main coronary artery or in a target vessel which has undergone previous bypass procedures.
- All operators must be trained prior to using the OPTIS Integrated System, the OPTIS Mobile System and the Dragonfly Imaging Catheter.
- Only 100% contrast media is approved for human use.
- Store the catheter at ambient temperature in a dry location out of direct sunlight.
- Never attempt to attach or detach a catheter to the DOC while the “lock” LED is lit.
- Do not kink, sharply bend, pinch, or crush the catheter at any time.
- The catheter is for single use only. Do not reuse, re-sterilize, or reprocess.
- The catheter is sterilized by ethylene oxide and is intended for one time use only. Non-pyrogenic. Do not use if the package is opened or damaged.
- After use, the catheter may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
- The catheter has no user serviceable parts. Do not attempt to repair or alter any part of the catheter assembly as provided.
POTENTIAL ADVERSE EVENTS
Potential complications which may be encountered during all catheterization procedures include, but are not limited to: acute myocardial infarction or unstable angina, allergic reaction to the contrast media, arterial dissection, injury, or perforation, cardiac arrhythmias, coronary artery spasm, embolism, thrombus formation, or death.
Caution: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use provided inside the product carton (when available) or at eifu.abbottvascular.com or at manuals.sjm.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
QUANTIEN™ Measurement System
INTENDED USE
The QUANTIEN™ system is 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.
INDICATIONS
The QUANTIEN™ Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.
The QUANTIEN™ Measurement System is 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.
CONTRAINDICATIONS
The device has no patient alarm functions. Do not use it for cardiac monitoring.
WARNINGS
- No modification of this equipment is allowed.
- Do not open or remove access covers on the QUANTIEN™ system unless specifically instructed by St Jude Medical technical support to do so.
- External equipment intended for connection to signal input, signal output or other connectors, shall comply with relevant IEC standard (e.g., IEC 60601 series for medical electrical equipment). In addition, all such combinations of systems shall comply with the standard IEC 60601-1-1, Safety requirements for medical electrical systems, alternatively IEC 60601-1 ed.3 §16, ME SYSTEMS. Any person who connects external equipment to signal output, or other connectors, has formed a system and is therefore responsible for compliance of the system with these requirements.
- Do not use the QUANTIEN system if it has been dropped or in any other way exposed to mechanical or electrical damage. This can cause the user or patient to be exposed to electric shock or cause faulty readings of data.
- High frequency surgical equipment must not be used on a patient at the same time as PressureWire™ guidewire and the QUANTIEN system.
- Do not use the QUANTIEN system if liquid is suspected to have penetrated the enclosure or the power supply unit. This can cause the user or patient to be exposed to electric shock.
- Do not sterilize the QUANTIEN system or any of its parts.
- Do not use this system or any of its parts if it has been sterilized.
- The QUANTIEN system contains a lithium battery for the system real-time clock. Danger of explosion. Battery is not intended to be replaced
PRECAUTIONS
- The QUANTIEN™ system is Type CF equipment and protected against the effects of a discharge of a defibrillator. PressureWire guidewire readings may be affected by defibrillation. After defibrillation restart procedure, i.e. re-zero and re-equalize PressureWire guidewire.
- If it is necessary to install the QUANTIEN system adjacent to other equipment, this system should be observed to verify normal operation. If abnormal performance is observed, it is necessary to increase distance between equipment.
POTENTIAL ADVERSE EVENTS
Potential complications which may be encountered during all catheterization procedures include, but are not limited to: acute myocardial infarction or unstable angina, allergic reaction to the contrast media, arterial dissection, injury, or perforation, cardiac arrhythmias, coronary artery spasm, embolism, thrombus formation, or death.
Caution: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use provided inside the product carton (when available), at eifu.abbottvascular.com or at Manuals.sjm.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events
PressureWire™ X Guidewire
INDICATIONS
The PressureWire™ X Guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X Guidewire can also measure blood temperature.
CONTRAINDICATIONS
This guidewire is contraindicated for use in the cerebral vasculature.
WARNINGS
- No modification of this device is allowed.
- The PressureWire™ X Guidewire is supplied sterile. Discard the guidewire if the pouch is opened or damaged, compromising the sterile barrier. The guidewire is designed for single use only and shall not be reused or resterilized. Adverse effects of using a non-sterile or resterilized guidewire may include, but are not limited to:
- Local and/or systemic infection
- Mechanical damage
- Inaccurate readings
- Observe all guidewire movements. Whenever the guidewire is moved or torqued, the tip movement should be examined under fluoroscopy. Never push, withdraw, or torque the guidewire if it meets resistance or without observing corresponding movement of the tip, otherwise vessel/ventricle trauma may occur.
- Torquing or excessive manipulation of the guidewire in a sharp bend, against resistance, or repeated attempts to cross a total vessel occlusion may:
- Cause dissection or perforation of blood vessels
- Cause vessel spasm
- Damage and/or fracture the guidewire
- When introducing the guidewire, flush the catheter and administer anticoagulation as for a standard catheterization procedure or clotting may occur.
- Do not use the guidewire in the ventricles if the patient has a prosthetic mechanical or biological valve. It may result in damage to both the prosthesis and the guidewire, which may cause injury or death.
- Use of the PressureWire™ X Guidewire in conjunction with interventional devices with a short rapid exchange may result in a folded or fractured guidewire.
- High frequency surgical devices must not be used on a patient at the same time as the guidewire.
PRECAUTIONS
- The PressureWire™ X Guidewire is a delicate instrument and should be handled carefully.
- Make sure that the transmitter is kept dry to ensure accurate pressure and/or temperature readings. Inaccurate readings may necessitate device replacement.
- Do not use the guidewire in conjunction with atherectomy catheters. It may damage the guidewire.
- Do not withdraw or manipulate the guidewire in a sharp-edged object. It may result in abrasion of the guidewire coating.
- Factors that may affect the accuracy of the diagnostic information include, but are not limited to:
- Improper placement of the aortic pressure sensor.
- Failure to achieve maximum coronary and myocardial hyperemia.
- Blood flow affected by the position of interventional devices, such as balloon catheters.
- Guidewire readings may be affected by defibrillation. Rezero the guidewire after defibrillation use.
- Do not measure pressure when the guidewire sensor element is in a sharp bend or in contact with atrial or ventricular walls. It might result in pressure artifacts.
- Do not use the PressureWire™ X Guidewire together with another guidewire, for so called jailed wire technique, due to difficulty in guidewire withdrawal and possible guidewire entrapment.
- Store at room temperature in a dry and dark place.
POTENTIAL ADVERSE EVENTS
Potential complications which may be encountered during all catheterization procedures include, but are not limited to: vessel dissection or occlusion, perforation, embolus, spasm, local and/or systemic infection, pneumothorax, congestive heart failure, myocardial infarction, hypotension, chest pain, renal insufficiency, serious arrhythmias, or death.