Read this section in full before using Baby FM.

Intended Use: Baby FM is a Class IIa medical device intended for continuous or spot-check body temperature monitoring. It measures axillary (underarm) body temperature using a wearable thermometer sensor that transmits data wirelessly to the Baby FM smartphone app via Bluetooth.

Warnings: Under no circumstances may this device be used for diagnostic purposes or to make decisions in situations considered to be life-threatening.

• Baby FM is intended for temperature monitoring only. Always consult a qualified healthcare professional for diagnosis and treatment.
• Do not ignore symptoms or medical advice, even if temperature measurements appear normal.
• This product is intended for use by adults (18 years or older). When used with infants or children, a parent or caregiver must supervise at all times.
• Do not use the device on damaged, irritated, or broken skin.
• Do not use the device if it is visibly damaged.
• The device contains a CR2032 lithium coin cell battery. Keep batteries out of reach of children. Swallowing a battery can cause severe internal injury or death within 2 hours. If battery ingestion is suspected, seek emergency medical attention immediately.
• Do not expose the device to temperatures outside the specified storage range (-10 C to +50 C).
• Do not submerge the device in water or any liquid.
• Do not attempt to open, repair, or modify the device. There are no user-serviceable parts inside other than the battery.

Cautions

• Measurements are intended as supportive clinical information. Do not rely solely on Baby FM readings for clinical decisions.
• Axillary temperature readings may differ from oral, rectal, or tympanic readings. Consult your healthcare provider if you are unsure how to interpret your results.
• Factors that may affect accuracy: recent physical activity, eating, drinking, bathing, environmental drafts, direct sunlight, and excessive sweating.

When to Seek Medical Care

• Infant under 3 months with an axillary reading >= 37.5 C (99.5 F).
• Fever persists for more than 3 days.
• Temperature is very high: >= 40.0 C (104 F).
• Red-flag symptoms are present, including lethargy, stiff neck, breathing difficulty, rash, or signs of dehydration.
• The person is immunocompromised.