Breas Vivo 3 User Manual page 12

Risk of Unnoticed Critical Conditions
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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 verified to be compatible with the Vivo 3 might affect
safety features and performance negatively.
Only use the Vivo with accessories that are compatible with the ventilator. Use of incom-
patible parts to connect the ventilator to the patient can result in degraded performance
and change of pressure gradient.
Breas Medical has verified the compatibility between the Vivo 3 and the accessories listed
in the Clinician's manual.
The responsible organization must ensure the compatibility of the ventilator with all
parts used to connect to the patient before starting the intended treatment. If incompati-
ble accessories are used, Breas Medical AB has no responsibility for the safe and effective
use of the Vivo 3.
WARNING!
Risk of Electric Shock
Modifying or using the ventilator with incompatible accessories may cause cardiac
arrhythmia.
The Vivo 3 must only be used in original and unmodified shape and only with compati-
ble accessories.
Inadequate use of device or accessories may cause loss of treatment or decreased
performance.
WARNING!
Risk of Burns
Covering breathing tubes with a blanket or heating them with an overhead heater can
affect the quality of the therapy or injure the patient.
CAUTION!
Proper placement and positioning of the patient interface is critical to the consistent
operation of this equipment.
Handle the Vivo 3 with care.
Always use the therapeutic pressure setting, as individually determined with the configu-
ration of the equipment and accessories.
Make sure to place and pack the device in a way that prevents unintentional start of the
machine.
10 Safety Information
User Manual
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.
Doc. 007231 F-3