| Requirement | Specifications | Justification |
| 1. The device must be able to measure the pressure applied by the mask onto the nose bridge, cheeks, and chin. | 1.1. Measure pressure on nose bridge, cheeks, and chin at 10-100 mmHg.8,9 1.2. Pressure measurements above 95% accuracy. | This range describes pressures applied to nose bridge, cheeks, and chin, which are most susceptible to pressure ulcers.5 Above 95% accuracy provides a proper confidence interval for medical devices.10 |
| 2. The device must actively adjust in response to detected pressure that exceeds safe time frames. | 2.1. Adjustments must be initiated when pressure exceeds 30 mm Hg for longer than an hour.11,12,13 2.2. Adjustment will be terminated when pressure is reduced to 25 mmHg. | Blood vessels become occluded when applied pressure exceeds capillary pressure for prolonged periods of time.11 This causes ischemia which leads to the formation of ulcers. |
| 3. The device must allow for normal airflow functionality of the noninvasive ventilation mask. | 3.1. The pressure between the device and skin interface must be 1.5 mmHg greater than the patient’s peak inspiratory airway pressure. | A pressure range that is 1.5-2.5 mmHg greater than peak inspiratory airway pressure is enough to prevent extensive air leaks that could interfere with desired airflow.14 BiPAP circuits typically deliver an inspiratory airway pressure of 5-20 mmHg.15 |
| 4. The wearable components of the device must be lightweight. | 4.1. The weight of the wearable components of the device must not exceed 1 ounce in addition to the existing mask. | Heavy masks may negatively impact patient compliance when used in a home setting.16 The weight of the mask must not cause additional and excessive pressure on a patient’s face, as current masks are 3-4.5 ounces. |
| 5. The device must be powered for a clinically relevant period of time. | 5.1. The device must be powered for 8 hours of passive pressure sensing and active adjustments. | Most long term therapies last anywhere between 6-8 hours, across treatments in the hospital or for at home use.5 Thus, the active and passive components must be powered for 8 hours. |
| 6. The noise generated by the device must not impact a patient’s quality of sleep. | 6.1. Noise generated by device should be less than 40 dB.17 | Exceeding this decibel threshold can result in sleep disturbances. Quiet noises would positively impact patient compliance, avoid potential damage to patient’s hearing, and prevent sleep disruption. |
| 7. The device must be able to be disinfected between patient uses. | 7.1. The device must follow the disinfection guidelines of ISO 17664-1. | Noninvasive ventilation devices are disinfected during repeated use by the same patient.18 Thus, following the current cleaning procedures, the device can be properly disinfected. |
| 8. The device must adhere to electrical safety standards. | 8.1. The device must follow the guidelines of IEC 60601-1-12. | Electrical components of the device integrated into the mask must be safe for use on the patients face while promoting safety during exposure to high voltage sources. |
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