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INDICATIONS FOR USE

The nitric oxide from the LungFit PH System is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. Refer to the full Prescribing Information within the LungFit PH System Operator’s Manual before use.

IMPORTANT SAFETY INFORMATION

• The nitric oxide from the LungFit PH is contraindicated in neonates dependent on right-to-left shunting of blood.
• Methemoglobin levels increase with the dose of nitric oxide; it can take 8 hours or more before steady-state methemoglobin levels are attained. Monitor methemoglobin and adjust the dose of nitric oxide to optimize oxygenation.

DEVICE WARNINGS

• Persons using the LungFit PH System should be trained and experienced in its use before performing procedures described in this manual to assure effective administration of nitric oxide and to avoid injury to the patient or to others resulting from inhalation of excess nitric oxide, nitrogen dioxide, or other reaction products.
• Abrupt discontinuation of nitric oxide may lead to worsening oxygenation and increasing pulmonary artery pressure, ie., Rebound Pulmonary Hypertension Syndrome. Signs and symptoms of Rebound Pulmonary Hypertension Syndrome include hypoxemia, systemic hypotension, bradycardia, and decreased cardiac output. If Rebound Pulmonary Hypertension occurs, reinstate nitric oxide therapy immediately. 
• A non-expired NO₂ Filter must be properly installed at all times for the LungFit PH System to function. Always have at least 1 spare NO₂ Filter available.
• Do not make unauthorized changes to the device as it can result in harm to the patient.

CAUTION

• To maintain the LungFit PH batteries in a charged state, keep the system plugged in between uses.

Rx Only

Consult the LungFit PH System Operator’s Manual for complete information. For technical support, call 1-855-586-4359.