Verification Protocols
Requirement 1: Comfort
Requirement 1 states that the device must be comfortable for the patient to wear in at- home environments. Thus, the weight must fall below 9.1 lbs (10% of body weight for a short, healthy adult), as it is not recommended for an adult to carry more than 10% of their body weight for an extended period of time.
Requirement 2: Monitor Continuously
A 12-hour continuous use test will be conducted while device is attached to a contraption (see below).
Requirement 3: Cough Detection (Accelerometer/Gyroscope)
The industry-standard procedure for accelerometer and gyroscope verification is to assume the sensors are able to measure the parameters stated on the specification sheet. Therefore, because the spec sheets for the accelerometer and gyroscope state that 2-30 m/s2 and 0-60° m/s2 are within the range of measurability, this is assumed within the context of testing to be correct.
Requirement 4: Data Storage
Theoretical storage for 12 hours and 1 month of data must be calculated, then compared with actual storage and made sure not to fall over the limit.
Requirement 5: Classification
Results must be classified into mild/moderate/severe coughs, or no coughs at all, after a variety of walk cycles, cough intensities, and daily activities.
Requirement 6: Feedback
Results must be displayed back to the user in an ADA-compliant visual manner, with power-on and low-battery LED indicators present.
Requirement 7: Noise Generation
Measurements of noise generated by the app and those of background noise must have a difference of less than 40 dB.
Requirement 8: Leakage Current
Requirement 9: Cleanable
Device is already able, by design (of ABS plastic), to be cleaned/disinfected.
Requirement 10: Wet/Dry Classification
Classification algorithm must display the ability to classify coughs between wet and dry.
Validation Protocols
Requirement 1: Comfort
A user survey of at least 10 people (ideally 12) will validate whether or not the device is comfortable for the average patient to wear.
Requirement 3: Cough Detection
A spirometer (measurement of flow rate) must be used to compare a cough to normal breathing.
Requirement 5: Classification
Use the spirometer to simulate different severities of cough, then measure. Compare with data from device.
Requirement 6: Feedback
User survey must be conducted to reveal whether or not users are able to see the data.
Requirement 10: Wet/Dry Classification
Use the spirometer to simulate productive and non-productive coughs, then measure. Compare with data from device.