Arterial Pressure Monitoring Set/Tray
Spectrum Vascular
FDA Clearance Information
FDA-Cleared Indications
- For use with compatible intravascular diagnostic catheters and pressure-monitoring equipment to measure arterial pressure.
- For monitoring arterial pressure during intravascular diagnostic or interventional procedures.
Clinical Applications
- Continuous arterial pressure monitoring during catheter-based vascular procedures.
- Connection of an arterial catheter to a pressure transducer and monitoring system.
- Hemodynamic monitoring during diagnostic angiography or embolization procedures.
- Arterial pressure measurement when intermittent cuff measurements are inadequate or unavailable.
Reported off-label uses
- Continuous arterial pressure monitoring in an operating room or intensive care unit through an indwelling arterial catheter, when used outside the device's specific labeling.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- Confirm compatibility among the arterial catheter, tubing, pressure transducer, flush solution, and monitoring system before use.
- Available configurations may differ in tubing length, stopcock arrangement, connectors, flush components, and included accessories; verify the product-specific instructions for use.
- Use sterile technique and remove air from the fluid pathway before connection to reduce the risk of air embolism or inaccurate pressure readings.
- MRI safety depends on the specific components, including any transducer, cable, or metal-containing parts; check the complete system's MRI labeling before scanning.
- Do not use if the package is damaged, opened, expired, or otherwise compromised. Follow the labeled contraindications, warnings, and instructions for use.
Procedures that use this device
Frequently Asked Questions
What is an arterial pressure monitoring set used for?
It connects an arterial catheter to a pressure-monitoring system so clinicians can measure arterial blood pressure continuously during a procedure or other monitored setting.
Is an arterial pressure monitoring set MRI safe?
MRI safety varies by the specific set and by connected components such as the pressure transducer and cable. Check the complete system's product labeling before an MRI examination.
What sizes are arterial pressure monitoring sets available in?
The set may be supplied in different tubing lengths and configurations rather than a single standard size. Select the configuration and connector type that match the catheter, transducer, and monitoring equipment.
How long does an arterial pressure monitoring set last?
Most sets are sterile, single-use devices and are discarded after the procedure or according to the manufacturer's instructions. They are not intended for indefinite reuse.
How much does an arterial pressure monitoring set cost?
Cost varies by configuration, included components, supplier, and purchasing agreement. Patients typically do not purchase the set separately; it is generally included in the facility's procedure or hospital charges.