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 integrated/imbedded 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.