Although this medical device complies with applicable electromagnetic compatibility (EMC) standards, electromagnetic disturbances may still occur in some environments. Strong electromagnetic fields can affect the device’s performance, and the device itself may affect nearby equipment.

Recommended separation distances

• Keep the device at least 1 m away from strong electromagnetic fields such as mobile phones and radio installations (per EN 60601-1-2, table 5).
• During a measurement, make sure no mobile device or other electrical device that emits electromagnetic fields is within 30 cm of the thermometer. This may result in incorrect operation and/or an inaccurate reading.

Sources to keep away from

MRI systems, diathermy equipment, HF surgical equipment, radio transmitters and receivers, walkie-talkies, Wi-Fi routers at very close range, mobile phones in hotspot or high-power modes, and induction cookers.

Do not use the device in the immediate vicinity of imaging rooms or physiotherapy diathermy, or inside shielded medical environments, unless permitted by the facility.

If you suspect interference

If the device provides unexpected readings, alarms, or connection loss, check for nearby electromagnetic sources, increase the distance, switch off the emitter or move to a different location, and repeat the measurement.

Devices that may be affected

• Sensitive medical implants and equipment — pacemakers, defibrillators, ECG/EEG/EMG devices — may be susceptible to RF interference. Maintain a prudent distance and follow their manufacturers’ instructions.
• Home electronics with poor EMC immunity may experience disturbance if placed immediately adjacent to the device or phone.

Defibrillation

The Baby FM device is not designed or validated for use in combination with defibrillation equipment. Application of external defibrillation currents can interfere with device function and may cause damage to the medical device.

• Electromagnetic disturbance: high-energy pulses from defibrillators may induce transient voltages or disturb Bluetooth communication.
• Device reliability: no testing under defibrillation conditions has been performed; functionality cannot be guaranteed during or immediately after a defibrillation event.