2 Safety Information
2.1 General User Precautions
WARNING!
When a patient is treated, there must be a supervising person present during the treat-
ment in order to take care of alarms and conditions that the patient cannot solve on their
own.
Always have immediate access to an alternative means of ventilation, which is ready for
use, to avoid patient death or serious injury. Failure to have an alternate means of ventila-
tion can result in serious injury or patient death if ventilator fails.
Failure to have an alternative means of ventilation can result in serious injury or patient
death if ventilator fails.
The Vivo 65 must be turned off and on at least every 90 days. This is necessary in order
for the Vivo 65 to perform a complete self-test. The self-test automatically tests the
alarm sound and certain components.
If you are admitted to a hospital or are prescribed any other form of medical treatment,
always inform the medical staff that you are on mechanical ventilation treatment.
The Vivo 65 must only be used:
• for the intended treatment in accordance with this operating manual and with the
instructions given by the responsible clinical personnel;
• in accordance with the operating conditions specified in this operating manual;
• in original and unmodified form and only with accessories specified or approved
by Breas Medical.
Do not use the Vivo 65 in the event of suspected damage to the device, unexplainable or
sudden pressure, performance or sound changes during operation, or if the delivered air
from the Vivo 65 is abnormally hot or emits an odour. In these cases, contact the
patient’s responsible care provider for an inspection.
The Vivo 65 may not work properly if any part has been dropped, damaged or sub-
merged in water.
Inadequate use of device or accessories may cause loss of treatment or decreased
performance.
The Vivo 65 therapy settings must always be based on medical advice and must be car-
ried out by authorised clinical personnel only. Blood gas measurement shall be per-
formed when changing treatment settings or changing to another device.
Always perform the procedure in4.5 Inspecting the Vivo 65 before Use, page 39 before use.
Safety Information 11
Doc. 006150 M-1 User manual