INDICATIONS AND IMPORTANT SAFETY INFORMATION
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QUANTIENTM Measurement System
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.
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.
The device has no patient alarm functions. Do not use it for cardiac monitoring.
- 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
- 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.
AP2946267-WBU Rev. A