Patient Circuit - Warnings And Precautions - Breas Vivo 3 Clinician Manual

2.4 Patient Circuit — Warnings and Precautions
WARNING!
Risk of Insufficient Ventilation
Insufficient ventilation may cause transient hypoxia.
The Vivo 3 ventilator is intended to be used with patient circuits with intentional leak-
age and compliant to ISO 17510. Recommended leak rate: 20 to 50 liters per minute
at 10 cmH
Failure to use a mask or accessory that minimizes rebreathing of carbon dioxide or
permits spontaneous breathing can cause asphyxiation.
Risk of Abnormal Exhalation Volume Measurement
Non-invasive ventilation: The exhaled volume of the patient can differ from the
measured exhaled volume due to unintentional leaks around the mask.
Invasive ventilation: The exhaled volume of the patient can differ from the measured
exhaled volume due to unintentional leaks around the cannula.
For correct measurements, minimize unintentional leaks.
Risk of Reduced Safety and Performance
Accessories that have not been tested with the Vivo 3 might affect safety features and
performance negatively. Only use the Vivo 3 with accessories approved by
Breas Medical.
Incompatible parts can result in degraded performance and change of pressure
gradient.
If unapproved accessories are used, Breas Medical has no responsibility for the safe
and effective use of the Vivo 3.
The responsible organization is responsible for ensuring the compatibility of the ven-
tilator and all parts used to connect to the patient before use.
Risk of Reduced Performance
Filters and patient connected parts must be replaced regularly to ensure correct func-
tion of the Vivo 3.
Risk of Insufficient Ventilation
Insufficient ventilation may cause transient hypoxia.
Before use:
• Make sure that the patient circuit and joined parts are undamaged and correctly
connected, in order to avoid unwanted leakage.
• Make sure that the leakage port of the circuit or mask is not blocked or obstructed.
This port prevents rebreathing by flushing the exhaled air.
• For active exhalation valve circuits: Check the function of the exhalation valve and
that is not blocked or obstructed.
• The Vivo 3 should be turned on and the function of the leakage port should be
checked before use: The pressurized air from the Vivo 3 causes a continuous flow
of air through the leakage port, enabling flushing of exhaled air.
22 Safety Information
Vivo 3 Clinician's Manual
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