Contraindications - Breas Vivo 3 User Manual

The lay operator may also perform basic maintenance that doesn't require special equipment
or a service environment.
Training
The lay operator shall be trained to basic knowledge of the Vivo 3 and in the specific opera-
tions they are assigned to perform. The training shall be based on this user manual and the
responsible clinical personnel shall assess the level of training required for each lay operator.
This manual shall be available for training and as reference when operating the Vivo 3.
1.5

Contraindications

The Vivo 3 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 ventilatory
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 3 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 3, a physician or responsible clinician should be contacted immediately.
The following side effects may occur during the course of therapy with the Vivo 3, 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
Doc. 007231 F-3
Introduction 7
User Manual