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The User manual is intended for lay operator. It shall be available for the training and as
reference when operating the Vivo 2.
1.4.3
Service Personnel
Certified service personnel with responsibility to maintain the equipment in proper
working order. They have a technical education and/or relevant experience of technical
work on electrical equipment. If local or national regulations requests additional author-
ization or competence, these shall be complied to.
Certified service personnel may perform any repairs, upgrades or service operations that
they have been certified to perform, as long as they have the required equipment and
the operation is performed in an appropriate environment. They may also operate soft-
ware applications for follow-up on ventilators usage and for troubleshooting.
Training and Certification
Service personnel shall be trained on the Vivo 2 and certified by Breas for being allowed
to perform any service, repairs or other operations on the Vivo 2. The training consists
of reading the services manual in full.
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1.5
Contraindications
The Vivo 2 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:
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Doc. 007229 D-3
The Service Manual.
The Clinician's Manual.
Service bulletins, available for certified service personnel on the Breas extranet.
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
Introduction
13
User manual
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