Intended purpose
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heyer_LUVAR_UserManual_EN-3_CRev-1
Other terms
Terms Meaning
Frequency (Freq) Breaths per minute (bpm)
Tidal volume (VT) Volume of air inhaled and exhaled during one
breath in milliliters (ml)
Leakage Volume of air escaping unused between de-
vice and patient in liters per minute (l/min).
Minute volume (MV) Volume of air inhaled and exhaled over the
course of one minute in liters (l/min).
Intended purpose
The CPAP and BiLevel system is intended as an active therapeutic medical device
for the treatment of sleep-related breathing disorders or forms of respiratory insuf-
ficiency in patients weighing more than 30 kg.
The clinical benefit of CPAP and BiLevel therapy for obstructive sleep apnea is a
reduction in apnea and hypopnea events.
WARNING: Patient hazard due to use outside the intended purpose!
• Sleep apnea respiratory therapy devices cannot be used for life-sustaining
measures. They are generally not suitable for patients who require ventilator
support or are dependent on a ventilator, or for patients who have had a tube
inserted through the mouth or through an incision in the windpipe (tracheal
or tracheostomy intubation).
This respiratory therapy device is intended for use and operation by a single un-
trained user at a time, under professional supervision, in health care facilities or
unsupervised in home health care.
The expected service life, assuming average daily use of 8 hours, is 5 years.
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