800953 Bittium Faros Manual
© Bittium Biosignals Ltd 2023
Any incident (serious or non-serious) that has occurred in relation to the device shall be
reported to the manufacturer and the competent authority of the Member State in which
the user and/or patient is established.
Bittium Faros 180 L does not have any electrical stimulation capabilities.
Accelerometer data is not analyzed within the device or differentiated between various
physical activities.
Bittium Faros 180L device should be kept closer than 10 meters to the Bluetooth companion
device for wireless communication.
Faros ECG sensor housing materials are tested and comply with ISO 10993 biocompatibility
requirements.
Stop using the device if housing or cable set causes adverse reactions such as blisters and
burning.
Bittium recommends using CE marked AMBU disposable ECG electrodes with Faros sensor
when measurement is performed using cable sets. Operator shall consult patient’s allergies
prior to electrode selection. ECG electrodes might cause mild skin irritation, red dots or
rash.
Stop using the device and remove ECG electrode from skin if electrode causes adverse
reactions such as blisters and burning.
Even though materials used in Faros ECG sensor and cables and ECG electrodes are biocom-
patible it might cause mild skin irritation or rash. Check for secure absence of skin reaction
on a daily basis.
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