1.2 Intended Use
Nippy 4 is intended to provide non-invasive or invasive ventilation for adult or paediatric
patients weighing over 10 kg (22 lbs) who require long-term support or mechanical ventila-
tion for respiratory insufficiency or respiratory failure, with or without obstructive sleep
apnea.
Nippy 4 is intended for spontaneously breathing patients.
1.3 Contraindications
The Nippy 4 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 Nippy 4 is contraindicated in an MRI environment.
Adverse Effects
If the patient experiences chest discomfort, pain, severe headache or shortness of breath
while using the Nippy 4, a physician or responsible clinician should be contacted
immediately.
The following side effects may occur during the course of therapy with the Nippy 4,
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
1.4 Intended Environment
The Nippy 4 is intended to be used in clinical settings (e.g. hospitals, sub-acute care institu-
tions), public spaces and home environments as well as during portable applications such as
wheelchairs, personal family vehicles, ground ambulances and civil aircraft, excluding
helicopters.
It is not intended for use during emergency transportation.
Introduction
9
Doc. 006553 M-6 User Manual
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