8 Safety Information
Vivo 65 users manual
Doc. 006088 En-US U-1b
• 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 odor. 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 submerged 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 carried out by authorized clinical personnel only. When
changing treatment settings or changing to another device, a clinical
assessment must be performed to determine if blood gas measure-
ment needs to be performed.
• Always perform the procedure “Inspecting the Vivo 65 before Use”
on page 39 before use.
• The Vivo 65 can be used for life-supporting treatment provided an
emergency equipment (e.g. resuscitation bag) is available, and that
one of the following configurations is used for surveillance of venti-
lator-dependent patient breathing:
– Dual limb patient circuit and insert with integrated exhalation valve:
The
Vivo 65’s internal measurement and monitoring of exhaled vol-
ume must be supervised.
– Single limb with leakage patient circuit: The
Vivo 65’s monitoring of
exhaled volume must be supervised
– Single limb with exhalation valve patient circuit: The CO
2
sensor or
an external EtCO
2
monitor (capnometer) must be used. The CO
2
sensor must be connected between the patient and the exhalation
valve to be able to measure exhaled gases. The CO
2
monitor shall ful-
fil the ISO 80601-2-55 standard (Medical electrical equipment - Par-
ticular requirements for the basic safety and essential performance of
respiratory gas monitors).
• Make sure that accessories are compatible with the Vivo 65 before
use.
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