Intended use

Baby FM is a Bluetooth continuous temperature monitor. The device senses, records and transmits body temperature via Bluetooth Low Energy to a compatible smart device running the Baby FM mobile application.

It is intended for continuous monitoring of human body temperature, for non-invasive, external use under the arm, with temperature data displayed, stored and analysed within the Baby FM app for health tracking and trend observation.

The thermometer operates in direct mode only: the displayed temperature is the actual measured value at the measurement site, without any automatic adjustment or correction applied.

Indications

Use this thermometer when an elevated body temperature is suspected. The device allows quick and easy measurement of human body temperature in the axilla (armpit) to determine whether the person has a fever.

Contraindications

Persons with limited mental, sensory or intellectual abilities should be supervised by a person responsible for their safety, and should receive instructions from that person on how to use the device.

Children or individuals unable to follow instructions should not use the device without supervision by a responsible adult or healthcare professional.

Where the device must not be used

• Not for use in explosive atmospheres or oxygen-enriched environments.
• Not for use on sites other than the axilla.
• Not for use outside the specified operating conditions (10 – 40 °C, 10 – 95 % relative humidity).

Medical judgment

Alarms and readings support but do not replace clinical judgment. If symptoms persist or readings are unexpected, seek medical advice. Use this device only as indicated in the User Manual: ignoring the indications for use can lead to hazardous situations, including inaccurate or delayed detection of fever, misinterpretation of readings, skin injury or irritation, loss of data or notifications, and device damage. If you cannot meet the indicated conditions of use, do not use the device and contact authorized support.