Attachment 1-Salient Characteristics.pdf

ESSENTIAL/SALIENT CHARACTERISTICS / OPERATION CONDITIONS

(Vyntus Body)

Essential / Salient Characteristics:

Diagnostic testing device capable of performing basic pulmonary function (PFT) measurements and calibrations. PFT also follows the current American Thoracic Society (ATS) standard. PFT programs to include pre and post Slow/Forced Spirometry, Lung Diffusion Capacity, Maximal Voluntary Ventilation (MVV), Plethysmography and Bronchial Challenge testing flexibility that allows the use of a dosimeter and an Aerosol Provocation system module that provides precise dosing/medication delivery. The PFT testing device has integrated programs that measure breath-by-breath volumes and flows, gas exchange measurements for DLCO. MIP/MEP measurements. PFT machine has flexible telescoping arm. PFT machine has capability of linking its program/system to other PFT machines and has the required certificates like a MEDCOI or similar to the DOD/DHA requirements that allows the machine to connect to MHS Genesis or DOD/DHA network to allow patient data or patient studies transfers and upload to the patient’s electronic record.

Operation Conditions:

Meets ATS Standards Device allows the technologist performing the measurements and calibrations to insert patient demographics and perform PFT procedures requested by provider that monitor and record patients’ breath-by-breath pulmonary function test results in correlation to testing procedure. Generates a standardized report that correlates all recorded data into one for technologist and physician use.