Breas Vivo 3 Clinician Manual page 17

Risk of Faulty Treatment
The responsible organization should periodically reassess the settings of the therapy
for effectiveness.
Risk of Faulty Treatment
Always prepare the Vivo 3 as described in this manual before use.
Risk of Unnoticed Critical Conditions
• All the physiological alarms of the Vivo 3 must be set at safe levels that will effec-
tively warn the user of any risk.
The alarm levels should be assessed considering the patient's treatment settings.
• Any change of treatment settings or change of components in the ventilation sys-
tem may require readjustment of the alarm levels.
• The alarm sound level should be set to a clearly audible level. Setting the alarm
sound level below that of the ambient sound level can impede recognition of
alarm conditions.
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 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.
WARNING!
Risk of Electric Shock
Modifying or using the ventilator with accessories that are not specified or approved
by Breas may cause cardiac arrhythmia.
The Vivo 3 must only be used in original and unmodified shape and only with acces-
sories specified or approved by Breas Medical.
Inadequate use of device or accessories may cause loss of treatment or decreased
performance.
Doc. 007232 Y-2
Safety Information 17
Vivo 3 Clinician's Manual