Description Of Unit; Intended Use; User Qualification - Weinmann BiLevel ST 22 Description Of Unit And Instructions For Use

1. Description of unit

1.1 Intended use

Use as a sleep therapy unit
BiLevel ST 22 is a BiLevel unit for treating sleep-related respiratory disorders, i.e. it uses two
pressure levels (inspiration = IPAP, exhalation = EPAP) to keep the airways open during
sleep. The unit is designed for adult patients with an autonomous respiratory drive. This is
in keeping with the following clinical scenarios:
• obstructive, mixed and central sleep-related respiratory disorders, e.g. OSAS, CS and
obstructive OHS.
BiLevel ST 22 is not designed for life-support.
When used as a sleep therapy unit, BiLevel ST 22 complies with EN ISO 17510-1 (sleep
apnea breathing therapy equipment).
Use as a ventilation device
BiLevel ST 22 is a ventilation device for non-invasive ventilation (not for life-support purpos-
es) of adult patients with respiratory insufficiency but capable of breathing autonomously.
This is in keeping with the following clinical scenarios:
• restrictive and obstructive ventilation problems, e.g. OSAS, COPD, obesitas hypoventila-
tion syndrome
• Problems with the mechanics of breathing, e.g. scoliosis or a chest deformity
• neurological, muscular and neuromuscular problems, e.g. diaphragmatic paresis
• Central respiratory regulation disturbances
BiLevel ST 22 is not designed for life-support.
When used as a breathing apparatus, BiLevel ST 22 complies with EN ISO 10651-6
(ventilatory support units).

1.2 User qualification

The settings on BiLevel ST 22 may only be set by a doctor and to suit the individual patient.
Description of unit
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EN