Breas Medical Vivo 45, User Manual

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11 Safety Information
Vivo 45 User Manual
Doc.006149 En Y-2
2 Safety Information
2.1 General User Precautions
• Vivo 45 must only be used:
– as prescribed by a qualified clinician, such as a physician or respira-
tory therapist.
– for the intended treatment in accordance with this manual and with
the instructions given by the responsible clinical personnel.
– in accordance with the operating conditions specified in this manual.
– in original and unmodified form and only with accessories specified
or approved by Breas Medical AB.
• Changes to the patient circuit, like adding or removing accessories or
changing type or length of breathing tube, may affect both circuit
compliance and alarm triggering conditions.
It’s recommended to perform a pre-use test and re-test the alarm
function after making changes to the patient circuit.
• When a patient is treated, there must be a supervising person present
during the treatment in order to take care of alarms and conditions
that the patient cannot solve on their own.
• To prevent disconnection of the tubing or tubing system during use,
only tubes in compliance with ISO 5367 or ISO 80601-2-74 should
be used.
• Covering breathing tubes with a blanket or heating them in an incu-
bator or with an overhead heater can affect the quality of the therapy
or injure the patient.
• If the patient is admitted to a hospital or is prescribed any other form
of medical treatment, always inform the medical staff that the patient
is on mechanical ventilation treatment.
• Do not use the Vivo 45 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 45 is
abnormally hot or emits an odour. In these cases, contact the
patient’s responsible care and service providers for an inspection.