Requirements

Device Requirements & Specifications

    1. The device must calculate Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC).
      • Justification:
        • FVC and FEV1 are predominantly used to assess lung function. Peak expiratory flow rate varies between males and females with males having and upwards of 550 L/min. In males 33-55 years of age, peak expiratory flow was 471.6 ± 91.8 L/min (2022)
      • Specification:
        • Use of FEV1 and FVC data must comply with usability and acceptability criterion in accordance with the ATS
        • FVC testing maneuvers must conform to procedures outlined by the ATS
        • Calculate these metrics from flows of up to 550 LPM

    2. The device must comply with standards for testing lung function set by the American Thoracic Society (ATS).
      • Justification:
        • The ATS ensures that all interpretations of respiratory function are clinically accurate and reliable. Regulation by the FDA requires that all respiratory devices are compliant with ATS standards. Compliance with ATS standards ensures contraindications to spirometry are followed
      • Specification:
        • The device must be able to be calibrated daily with a 3L syringe at 20, 280, and 550 LPM flow
        • Outcomes must be reported at BTPS (body temperature, ambient barometric pressure, saturated with water vapor)
        • Ambient temperature must be recorded within ±1°C of accuracy

    3. The electronic components of the device must meet medical device electrical standard IEC 60601 and IPX1 standards.
      • Justification:
        • Complying with electrical standards protects patients and health care providers from electrical hazards. Meeting standards allows the device to interact with other systems within a clinical setting
      • Specification:
        • Maximum allowable leakage current must be lower than 500 µA
        • Device must be protected against condensation or dripping water falling vertically

    4. The device must be able to store a patient’s personal information, raw data, calculations, and test conclusions.
      • Justification:
        • Electronically stored data allows users’ data to be accessible and continuously shared with healthcare providers. Storage of data allows longitudinal trends in pulmonary function to be observed and allows clinicians to improve treatment plans
      • Specification:
        • Age must be reported in years to one decimal place
        • Height must be reported in centimeters to one decimal place
        • Weight must be reported to the nearest 0.5 kg

    5. Stored data must be accessible to healthcare providers in accordance with HIPAA and HITECH regulations.
      • Justification:
        • Stored data must be secure and comply with HIPAA and HITECH standards
      • Specification:
        • Stored data must be password protected
        • Authorization must be obtained to retrieve data

    6. The device must be able to withstand cleaning and disinfection methods in accordance with ISO23747.
      • Justification:
        • Cleaning and disinfection avoids cross-contamination of infectious respiratory secretions
      • Specification:
        • All parts labeled as “reusable” must be able to be cleaned and disinfected
        • All components that come into contact with the patient or breathing gasses must be capable of being cleaned and disinfected

    7. The device must have secure, comfortable interface with patients mouths.
      • Justification:
        • Interface must fit all patients mouths to prevent leaks, discomfort and obstruction. Air leakage reduces measured FVC and FEV1 making lung function appear diminished and inaccurate
      • Specification:
        • The device must have minimal evidence of leak at the mouth piece or nose and no obstruction of the mouthpiece

    8. The device must be handheld.
      • Justification:
        • Device sizes that fit the 95th percentile accommodates the majority of the population allowing the device to be accessible to use
      • Specification:
        • The device must have a maximal handling circumference of 15.8 cm
        • The handle of the device must be longer than 9.6 cm

    9. The device must operate for a clinically relevant period of time.
      • Justification:
        • Allowing for the device to last for a long period of time allows the user to not to recharge it / change the batteries for at least a month assuming a maximum of 4 minute use per day
      • Specification:
        • The batteries must be able to power all electrical components
        • The device must last for a minimum of 2 hours on one charge