Requirement

I.  The device must monitor a baby’s physiological indicators (BPIs):

• Respiration rate (RR)
• Heart rate (HR)
• Temperature (Temp)

II. This device must create an auditory and visual alert when measured values are out of the healthy range.

III.  The device must be fluid tolerant to prevent risk of electrical shock due to contact via bodily fluids or washing.

IV.  The device must meet 16 CFR 1501.2, which is the Small Parts Regulation.

V.  The device’s power source must be able to supply power for the duration of an infant’s full night of sleep.

 

Specification

I.  The ranges of the sensor for each BPI must be

• RR: Device Range: 10-70 breaths/min & Healthy Range: 20-60 breaths/min
• HR: Device Range: 72-168 bpm & Healthy Range: 80-160 bpm
• Temp: Device Range: 33-39°C & Healthy Range: 34-38°C

II. An alert must be emitted when the device reads a measurement outside of the healthy range, set by Specification I.

III. All electrical components must be fluid resistant to prevent electrical shock while in use and must also be removable from the onesie for washing.

IV. All free parts near the baby must be larger than the specified designed test cylinder 2.25 inches long by 1.25 inches wide.

V. The device must function for a minimum of 12 hours. This will ensure that the device will last for a full night, regardless of whether the baby sleeps for that full amount of time.