1. The device must be able to detect body position.

• Specifications:
  • 1.1: Device must be able to accurately categorize sleeping position as supine or prone
• Justification:
  • Sleeping in the prone or lateral position can obstruct the baby’s airway leading to suffocation
  • Pediatrician recommended sleeping position is supine.

2. The device must be able to non-invasively measure body temperature.

• Specifications:
  • 2.1: Device must be able to accurately measure local temperatures between a range of 31°C to 39°C.
• Justification:
  • A body temperature outside the normal physiological range (35.5^oC to 37^oC) is an indicator of disease.

3. The device must be able to detect the sound signals of the baby.

• Specification:
  • 3.1: Device must be able to measure frequencies between a range of 1,000 Hz to 6,000 Hz.
• Justification:
• This frequency range includes those measured from crying due to reasons such as hunger, need of a diaper change, emotional needs, and physical discomfort or pain.

4. The device must be able to non-invasively measure respiratory rate.

• Specifications:
  • 4.1: Device must be able to accurately (RMSE ≤ 3 bpm) measure respiratory rate between 10 and 80 bpm.
• Justification:
  • Respiratory rate is important in determining whether professional medical care is required.
  • 18 to 68 breaths/min covers range of 98% of healthy children under 2.
  • Accuracy specification based on similar devices.
    

5. The device must be able to non-invasively measure heart rate.

• Specifications:
  • 5.1: Device must be able to accurately (± 5 bpm or ± 10%) measure heart rate between 70 and 210 bpm.
• Justification:
  • A heart rate outside the normal physiological range is an indicator of disease.
  • 80 to 185 bpm covers heart rates of 98% of normal children under 2 years old.
  • EC13 standard requires measurements to be accurate within ± 5 bpm or ± 10%, whichever is greater.
    

6. The device must take measurements in light and dark conditions.

• Specification:
  • 6.1: Minimum: 1 lux. Maximum: 300 lux. 
• Justification:
  • Babies sleep in dark and light environments.
  • Recommended: Adults indoor: 1-250 lux, Babies in NICU: 10-600 lux
    

7. The device must have the ability to set alarm limits based on input values. 

• Specifications:
  • 7.1: Low alarm: Indicates cautionary alarm; outside selected range. 
  • 7.2: High alarm: Indicates danger; measured values are at or exceeding hospitalization level.
  • 7.3 Alarm must be less than 100 dB.
• Justification:
  • Vitals vary per child. An alert must be generated as per a pediatrician’s recommendation.
  • Sounds over 100 dB can cause hearing loss.