800953 Bittium Faros Manual
© Bittium Biosignals Ltd 2023
2 GENERAL WARNINGS AND CAUTIONS TO REVIEW BEFORE USE
Do not operate Bittium Faros™ device without first reviewing the following notices. See also Appendix 3:
Bittium OmegaSnap electrodes supplementary information and Appendix 4: Bittium Faros 180L supplemen-
tary information.
WARNING: Do not disassemble, try to repair, or modify device.
WARNING: Device is not suitable for direct cardiac application.
WARNING: Do not touch parts of the computer, docking station or any non-medical electri-
cal equipment and the patient at the same time when operating the Faros ECG device.
WARNING: To avoid danger of electrical shock and electromagnetic disturbances, the com-
puter and associated equipment used with the Faros ECG device should comply with IEC/EN
60950 (IT and office equipment safety) or EN60601-1 (Medical electrical equipment safety)
standard. If a computer that does not comply with the IEC/EN 60601-1 requirements is used
in the patient environment, the computer and peripherals must be plugged in using an iso-
lation transformer that fulfils the requirements.
WARNING: Do not attempt self-diagnosis or self-treatment based on acquired data.
CAUTION: Faros device IP classification is IP67.
CAUTION: Operating environments: Professional healthcare facility environment and Home
healthcare environment.
CAUTION: Faros does not directly provide diagnosis as a supervising physician is responsible
for ECG data interpretation.
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