1.2 Intended Use
Vivo 45 is intended to provide non-invasive or invasive ventilation for adult or paediat-
ric patients weighing over 10 kg (22 lbs) who require long-term support or mechanical
ventilation for respiratory insufficiency or respiratory failure, with or without obstruc-
tive sleep apnea.
Vivo 45 is intended for spontaneously breathing patients.
1.3 Contraindications
The Vivo 45 is not a life-support ventilator and is contraindicated in patients who are
unable to tolerate more than brief interruptions in ventilation.
If a patient has any of the following conditions, therapy with positive airway pressure
may be contraindicated and the prescribing clinician shall decide if the benefit of ventila-
tory assistance overweighs the risks:
• Untreated pneumothorax
• Pneumomediastinum
• Inability to maintain a patent airway or adequately clear excessive respiratory
secretions
• Severe acute systemic complications (shock, unstable arrhythmias, myocardial
ischemia)
• Severe bullous lung disease
• Risk of vomiting
• Pathologically low blood pressure, especially if associated with intravascular volume
depletion
• Cerebrospinal fluid leak, recent cranial surgery or trauma
The use of the Vivo 45 is contraindicated in an MRI environment.
Adverse Effects
If the patient experiences chest discomfort, pain, severe headache or shortness of breath
while using the Vivo 45, a physician or responsible clinician should be contacted
immediately.
The following side effects may occur during the course of therapy with the Vivo 45,
patients are advised to report any new or changing adverse effects to their physician:
• Nasal, mouth or throat dryness
• Nosebleeds
• Abdominal bloating
• Ear or sinus discomfort
• Eye irritation
• Skin rashes
Introduction 11
Doc. 006149 D-3
Vivo 45 User manual
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