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VersaMed iVent201 - Cautions and Warnings

VersaMed iVent201
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Introduction
6
1.3 Cautions and Warnings
WARNING: The iVent
201
is a life-sustaining device. Do
not rely solely on the ventilator performance: always
make sure an alternative source of ventilation is
available. Clinical supervision of the patient is
mandatory.
CAUTION: The iVent
201
is a restricted medical device to
be operated by qualified medical personnel under the
direction of a qualified medical practitioner.
WARNING: Qualified medical personnel should
visually monitor patients on life-support ventilation.
Life-threatening conditions may arise that might not
activate alarms.
CAUTION: Always perform a complete Operation
Verification Test (O.V.T.) when connecting a new patient
circuit to the ventilator, and before using it on a patient.
Standard facility policy should be followed.
WARNING: Do not use the iVent
201
ventilator to treat
infants weighing less than 10 kg/ 22 lb.
CAUTION: The factory default setting for “Leak Alarm”
is set to ”off.” Users must manually set the leak alarm to
enable it.
WARNING: To prevent explosion hazard, do not use the
ventilator in the presence of flammable anaesthetics.

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