- The INOmax DSIR Plus Delivery Systems deliver INOMAX (nitric oxide) gas, for inhalation. The INOmax DSIR Plus Delivery Systems must only be used in accordance with the indications, usage, contraindications, and warnings and precautions described in the INOMAX package inserts and labeling. The approved patient population is limited to neonates. Refer to the INOMAX Full Prescribing Information prior to use.
- Abrupt discontinuation of INOMAX can lead to worsening oxygenation and increasing pulmonary artery pressure (rebound pulmonary hypertension syndrome). To avoid abrupt discontinuation, use the INOblender® or backup mode immediately to reinstate INOMAX therapy and refer to the INOMAX package insert.
- If the high NO2 alarm activates, the delivery system should be assessed for proper setup while maintaining INOMAX delivery.
- Do not connect items that are not specified as part of the system.
- If an alarm occurs, safeguard the patient first before troubleshooting or repair procedures.
- Use only INOMAX, pharmaceutical grade NO/N2.
Use in an MR Environment
- Only use a size “88” (1,963 liters) cylinder that is marked “MR Conditional. Keep cylinder at 100 gauss or less.” With the DSIR Plus MRI while in the scanner room. Use of any other cylinder may create a projectile hazard.
- The INOmax DSIR Plus MRI is classified as MR Conditional with MR scanners of 1.5 or 3.0 Tesla strength ONLY in areas where the field strength is less than 100 gauss.
- This device contains ferromagnetic components and hence will experience strong attraction close to the magnet. It should be operated at a fringe field of less than 100 gauss.
- A strong magnetic field such as that from an MRI system can affect the ability of the INOmeter to detect if the cylinder valve is open. This can cause a “Cylinder Valve Closed” alarm to occur when the cylinder valve is actually open. If this alarm occurs, reposition/rotate the INOmax DSIR Plus MRI cart outside the 100 gauss area to reduce the magnetic interference in the area of the INOmeter until the cylinder handle graphic on the display turns green. This will resolve the “Cylinder Valve Closed” alarm. Typically the required INOmax DSIR Plus MRI cart location adjustment is less than 6 inches (15 cm)/90 degrees. Note that interruption of INOMAX therapy will occur one hour from point when the “Cylinder Valve Closed” alarm is activated if the alarm is not resolved.
Consult the Operation and Maintenance Manual, which may be found at www.inomax.com/training-and-education/device-support-resources, for complete information. For technical assistance, call (877) 566-9466.