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The IRMA mainstream gas analyzer is intended to be connected to other medical devices for monitoring of breath rate and the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane. It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients. IRMA CO2 may also be used in the emergency medical services environment and road ambulances. Note: An IRMA mainstream gas analyzer shall only be connected to medical backboard devices approved by PHASEIN.

IRMA is a mainstream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to another medical backboard device for display of respiratory parameters. IRMA is connected to the patient breathing circuit via the Airway Adapter. This premarket submission adds the M80 device as a host backboard display to IRMA. There are no changes to the previously cleared sensor technology. The following IRMA models are available: a) IRMA CO2 (model/catalogue number 200101), measurement of CO2. b) IRMA AX+ (model/catalogue number 200601), measurement of CO2, N2O and anesthetic agents with automatic agent identification The IRMA product family also includes the adult and pediatric/infant Airway Adapter. A modura holder and velcro holder are offered as optional accessories.

The ISA product family consists of three types of sidestream gas analyzers (ISA CO2, ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for display of real time and derived monitoring data of the following breathing gases: ISA CO2: CO2 ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA CO2 is also intended to be used in road ambulances. The intended patient population is adult, pediatric and infant patients.

ISA is a sidestream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to a Host/Backboard Device for display of respiratory parameters. ISA is connected to the patient breathing circuit via the Nomoline sampling line that includes a water separation section and a bacteria filter. The following ISA models are available: a) ISA CO2 (model/catalogue number 800101), measurement of CO2. b) ISA AX+ (model/catalogue number 800601), measurement of CO2, N2O and 5 Anesthetic agents with automatic agent identification c) ISA OR+ (model/catalogue number 800401), measurement of CO2, O2, N2O and 5 Anesthetic agents with automatic agent identification (includes paramagnetic oxygen sensor). The ISA product family also includes the disposable Nomoline sampling line. A clamp adapter and modura holder are offered as optional accessories.

The VEO Multigas Monitor for Pocket PC, model 400601 is intended to provide monitoring of CO2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room and emergency medicine settings for adult, pediatric and infant patients.

The VEO Multigas Monitor for Pocket PC, model 400601 is a miniature mainstream infrared gas analysis bench. The complete multigas analyzer is contained within a transducer that is attached to the breathing circuit via an airway adapter.

The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients. The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.

The EMMA Emergency Capnometer is a miniature mainstream infrared gas analysis bench with an integrated user interface. The complete carbon dioxide analyzer is contained within a transducer that is attached to the breathing circuit via the EMMA Airway Adapter.

The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult and pediatric patients. The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult and pediatric patients.

The EMMA Emergency Capnometer is a miniature mainstream infrared gas analysis bench with an integrated user interface. The complete carbon dioxide analyzer is contained within a transducer that is attached to the breathing circuit via the EMMA Airway Adapter.