Invasive Use - Warnings And Precautions - Breas Vivo 3 Clinician Manual

WARNING!
Risk of Cross-Contamination
Deep tissue or mucosal contact with infectious agents may cause infections:
• If assigning the Vivo 3 to a new patient, always replace the filters.
• Always use the Vivo 3 with patient air inlet filters installed.
Risk of Cross-Contamination
Deep tissue or mucosal contact with infectious agents may cause infections.
If the Vivo 3 is used by several patients, a low resistance bacteria filter shall be used
between the air outlet and the patient circuit, for preventing patient cross-contamina-
tion. Reuse of bacteria filter, patient circuit or mask may expose patients to conta-
gious agents.
2.6 Invasive Use — Warnings and Precautions
WARNING!
Risk of Therapeutic System Performance or Failure
Invasive use of the attachable humidifier may cause reduced performance.
The attachable humidifier is not intended for invasive use.
Risk of Faulty Treatment
If using the Vivo 3 for invasive ventilation, humidification is recommended. Make
sure to use an external heated humidifier that complies to invasive use according to
ISO 80601-2-74.
Risk of Unnoticed Critical Conditions
When using the Vivo 3 invasively, physiological alarms, such as the low volume alarm
and the low breath rate alarm, must be carefully set, to ensure safe use.
Risk of Rebreathing
The Vivo 3 is equipped with a low leakage alarm. The low leakage alarm is not a sub-
stitute for operator vigilance in ensuring that the leakage ports remains clear at all
times. Periodically check the leakage ports during therapy.
Safety Information 25
Doc. 007232 Y-2 Vivo 3 Clinician's Manual