Read the entire User Manual before using the device. If you do not understand any instruction, contact customer care at support@babyfm.rs.

Intended Use: Baby FM is a Class IIa medical device intended for continuous monitoring of human body temperature. It measures axillary (underarm) body temperature using a wearable thermometer sensor that transmits data wirelessly to the Baby FM smartphone app via Bluetooth. It operates in direct mode only — the displayed reading is the actual measured value at the measurement site, with no correction applied.

Medical judgment: Alarms and readings support but do not replace clinical judgment. If symptoms persist or readings are unexpected, seek medical advice.

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.
• Intended use site: use only to measure body temperature at the axilla, on healthy, intact skin. Do not use on broken, inflamed, irritated, infected, or recently treated skin.
• Do not wear the device continuously for more than 24 hours.
• Do not use the device if the enclosure or battery compartment is cracked, deformed, loose, or cannot be closed securely.
• Handle with care. Avoid drops, crushing, excessive pressure, or vibration.
• Do not recharge: do not attempt to recharge the CR2032 battery. Risk of leakage, overheating, or explosion. Replace only with a CR2032 primary lithium coin cell from an approved supplier, observing polarity.
• Keep batteries away from children. Coin cells are a choking and ingestion hazard. If swallowed or inserted into any body part, seek immediate medical attention.
• Do not open the device. There are no user-serviceable parts inside. Opening may damage the device and void the warranty. Battery replacement via the battery compartment is the only permitted user operation.
• Liquids: do not submerge the device or expose it to running water. Keep it dry and clean only as instructed (wipe method).
• Do not sterilize. Sterilization can damage the electronics, enclosure, seals and labels. If a sterile device is required for a procedure, this product is not suitable for that use.
• Cleaning chemicals: use only the specified cleaning and disinfection agents at approved concentrations. Do not use solvents, oils, strong acids or alkalis, undiluted bleach, or abrasives.
• Environmental conditions: operate only within the specified temperature, humidity and pressure ranges (10 – 40 °C, 10 – 95 % relative humidity). Allow the device to acclimate to room conditions to avoid condensation.
• EMC warning: despite compliance with EMC standards, strong electromagnetic fields may cause disturbance. Keep away from MRI, diathermy or HF surgical equipment, powerful transmitters, and hotspots. If interference is suspected, increase the distance or relocate.
• Not validated with defibrillation equipment. Application of external defibrillation currents can interfere with device function and may damage the device.
• Use environment: not for use in explosive atmospheres or oxygen-enriched environments.
• Smartphone settings: if the phone is in Silent or Do Not Disturb mode, audible alarms may be suppressed. The app will display a banner. Adjust phone settings to receive audible alerts.
• Power loss: if the device loses power or connection (low battery, out of range), measurements may not be recorded. Replace the battery when notified and keep the phone within range.
• Patient identification: verify the correct patient is selected in the app before recording, interpreting or exporting data.
• Data privacy: measurement data are stored locally on the smartphone. Protect access to your phone; share or export data only as intended.
• Allergies and sensitivity: discontinue use and consult a healthcare professional if skin irritation or discomfort occurs at the placement site.
• Temperature handling: avoid direct heating or cooling sources, or intense sunlight, on the device during measurement — these can affect accuracy.
• Do not share the thermometer among individuals without properly disinfecting it first.

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. Wait at least 30 minutes after bathing, feeding or physical activity before measuring.
• Ignoring the exclusions and precautions in the User Manual can create hazardous situations, including inaccurate temperature readings, delayed detection of fever, skin injury or irritation, electric malfunction, battery leakage or explosion, loss of data or notifications, and damage to the device.