CARDIOVASCULAR
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The QUANTIEN integrated measurement system, with its wireless design, frees the cardiac cath lab from cables. The QUANTIEN system offers users full integration without time-consuming setup or lab downtime.

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EASY INTEGRATION INTO THE CARDIAC CATH LAB

The QUANTIEN system provides flexibility with easy installation, no clutter from cables in either floor or ceiling, and the ability for physicians to configure the cath lab environment exactly as needed. Used with the Wi-Box unit and the PressureWire X guidewire the QUANTIEN system’s main unit can be set up as a built-in or as a mobile device anywhere in the cath lab. These options can free up valuable table space and allow control by either sterile- or nonsterile-dressed staff.

QUANTIEN’s interaction with the PressureWire guidewire and wireless interface


ENHANCED DIAGNOSTIC DOCUMENTATION

The QUANTIEN system provides clear, concise documentation when assessing complex coronary disease, using both the distal coronary pressure to aortic pressure (Pd/Pa) ratio and hyperemic Fractional Flow Reserve (FFR). The system is designed to offer physicians the greatest practical advantages when performing percutaneous coronary intervention (PCI).

QUANTIEN SYSTEM’S FLEXIBILITY IN THE CATH LAB

The QUANTIEN system’s features offer users a variety of options.

Fast and Easy Wireless Physiology —physiology is always available when and where physicians want it, without time-consuming setup or cables.

Easy Placement—whether it’s on a desktop, on a wall, at the bedside or on a mobile pole.

Full Visibility—no matter where the QUANTIEN system main unit is placed, physicians can view its video screen on the existing cath lab monitors adjacent to the angio and hemo screens.

Touch Display—allows touch access to all features, with a touch screen technology and a high-resolution widescreen.

Full Connectivity—provides quick and easy procedures and full case documentation with DICOM‡, Worklist, DICOM‡ Archive, local network and USB memory stick data export.


Quantien system placement

‡ Indicates a third party trademark, which is property of its respective owner

ORDERING INFORMATION

REORDER NUMBER DESCRIPTION
C12787 QUANTIEN Measurement System
C12797 QUANTIEN Desktop stand
C12798 QUANTIEN Pole bracket
C12799 QUANTIEN Wall mount

To fasten the main unit bedside when no bedside mounted pole is available, order the Multipurpose Bracket C12777 and C12798 Pole Bracket.

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IMPORTANT SAFETY INFORMATION

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rx-only-logo QUANTIENTM 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.

AP2946552-WBU Rev. A

IMPORTANT SAFETY INFORMATION
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CAUTION: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
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