INO Therapeutics

INOmaxDSir Ventilator Breathing Systems Compatibility List Technical Bulletin TB-08007 Jan 2014

Technical Bulletin

4 Pages

Technical Bulletin Ref: TB-08007  Issue date: January 2014  Product: INOmax DSIR  ®  Priority: Low  Affected parts: Breathing Systems Compatibility  Classification: Information for Distribution  Subject: Ventilator/Breathing Systems Compatibility List WARNING:  In the United States, the approved patient population for the INOmax DSIR, as ® specified in the drug labeling for INOMAX (nitric oxide) for inhalation, is limited to term and near-term neonates with hypoxic respiratory failure. The INOmax DSIR is not intended to be used in other patient populations.  Outside of the United States, use of the INOmax DSIR is limited to the use in accordance with INOMAX or INOflo, nitric oxide for inhalation prescribing information as established with the national health authority.  Patient disconnect and high pressure alarms are required for the ventilator. The INOmax DSIR is compatible with most types of ventilators/breathing systems by connecting into the inspired limb of a patient’s breathing circuit. The system measures the gas flow in the breathing circuit and then injects NO/N2 gas to produce the set NO concentration in ppm. Measure  Specification  Inspiratory Flow Rate:  L/min  2 - 120  Respiratory Rate:  bpm  6 - 60  Airway Peak Pressure:  cmH2O  0 - 70  PEEP:  cmH2O  0 - 20  The INOmax DSIR has been validated against the following ventilators/breathing systems:  Ventilators/Breathing Systems validated for use in the United States:  Manufacturer  Model  A-plus Medical  Baby-Plus Bubble CPAP  Airon Corporation  pNeuton  Bear  750ps (Cub)  Bio-Med Devices  Crossvent 2  Neonatal  Pediatric/ Adult  Transport  High Frequency  Anesthesia  Nasal Continuous Positive Airway Pressure (CPAP)  ● ● ● ●  TB-08007 Update 01-2014 Ref. 20093 rev. 08, ECN # 201, 239, 286, 376, 580, 826, 991, CC-0118  Page 1 of 4  High Flow Nasal Cannula
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