Enhanced delivery features, designed with patient safety in mind

For more information about INOmax delivery system features, contact your representative

Validated and compatible with numerous gas delivery systems1-3,7

Listen to respiratory therapists speak about their experience with INOmax delivery systems.

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“During [a stressful time], the INOmax Total Care team stepped up to make sure that we had the equipment and tanks to fully support our requests and needs.”8

Explore more features of INOmax devices

INOmax EVOLVETM DS

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INOmax DSIR® Plus

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INOmax DSIR® Plus MRI

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APPLICATIONS

The INOmax EVOLVE DS and DSIR Plus delivery systems deliver INOmax (nitric oxide) gas, for inhalation. These delivery systems must only be used in accordance with the indications, usage, contraindications, and warnings and precautions described in the INOmax package insert and labeling and are indicated for use in term and near term (>34 weeks gestation) neonates with HRF associated with clinical or echocardiographic evidence of pulmonary hypertension. These delivery systems are indicated for a maximum of 14 days of use.

DEVICE WARNINGS

  • Abrupt discontinuation of INOmax can lead to worsening oxygenation and increasing pulmonary artery pressure (rebound pulmonary hypertension syndrome). To avoid abrupt discontinuation, use the EVOLVE DS eINOblender or the DSIR Plus INOblender as a backup immediately to reinstate INOmax therapy and refer to the INOmax package insert.
  • Do not discontinue INOmax delivery if the high NO2 alarm activates. Assess the delivery system for proper setup while maintaining INOmax delivery and verify INOmax and/or FiO2 are appropriate.
  • Do not use equipment that is not specified as part of the systems or that is not designed for INOmax mixtures. Using equipment that is not specified can cause the systems to malfunction.
  • If an alarm occurs, safeguard the patient first before performing troubleshooting procedures.
  • Use only INOmax, pharmaceutical grade NO.

Use in an MR Environment for INOmax DSIR Plus MRI only

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.

RX ONLY

For the INOmax DSIR Plus consult the Operation Manual which may be found at www.inomax.com/resources, for complete information. For information on the INOmax EVOLVE DS delivery system or for technical assistance for any of these INOmax Delivery Systems, call (877) 566-9466.

References: 1. INOmax DSIR®Plus Operation Manual. Hampton, NJ: INO Therapeutics LLC; 2014. 2. INOmax DSIR®Plus MRI Operation Manual. Hampton, NJ: INO Therapeutics LLC; 2015. 3. INOmax EVOLVE™ DS Operation Manual. Madison, WI: Mallinckrodt Pharmaceuticals; 2024. 4. Data on File – Ref-05507. Mallinckrodt Pharmaceuticals. 5. Data on File – Ref-05578. Mallinckrodt Pharmaceuticals. 6. Data on File – Ref-06554. Mallinckrodt Pharmaceuticals. 7. INOmax DSIR®Plus. Ventilator/Gas Delivery Systems Compatibility List. Technical Bulletin. TB-08007. Mallinckrodt Pharmaceuticals. 2020. 8. Data on File – Ref-06559. Mallinckrodt Pharmaceuticals.

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APPLICATIONS

  • The INOmax EVOLVE DS and 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.

APPLICATIONS

The INOmax EVOLVE DS and DSIR Plus delivery systems deliver INOmax (nitric oxide) gas, for inhalation. These delivery systems must only be used in accordance with the indications, usage, contraindications, and warnings and precautions described in the INOmax package insert and labeling and are indicated for use in term and near term (>34 weeks gestation) neonates with HRF associated with clinical or echocardiographic evidence of pulmonary hypertension. These delivery systems are indicated for a maximum of 14 days of use.

DEVICE WARNINGS

  • Abrupt discontinuation of INOmax can lead to worsening oxygenation and increasing pulmonary artery pressure (rebound pulmonary hypertension syndrome). To avoid abrupt discontinuation, use the EVOLVE DS eINOblender or the DSIR Plus INOblender as a backup immediately to reinstate INOmax therapy and refer to the INOmax package insert.
  • Do not discontinue INOmax delivery if the high NO2 alarm activates. Assess the delivery system for proper setup while maintaining INOmax delivery and verify INOmax and/or FiO2 are appropriate.
  • Do not use equipment that is not specified as part of the systems or that is not designed for INOmax mixtures. Using equipment that is not specified can cause the systems to malfunction.
  • If an alarm occurs, safeguard the patient first before performing troubleshooting procedures.
  • Use only INOmax, pharmaceutical grade NO.

Use in an MR Environment for INOmax DSIR Plus MRI only

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.

RX ONLY

For the INOmax DSIR Plus consult the Operation Manual which may be found at www.inomax.com/resources, for complete information. For information on the INOmax EVOLVE DS delivery system or for technical assistance for any of these INOmax Delivery Systems, call (877) 566-9466.