8 Instructions for use Babyleo TN500 SW 1.0n
Safety-related information
2 Safety-related information
2.1 Intended use
The IncuWarmer Babyleo TN500 is intended for use with premature babies and
neonates and can be used as both an incubator and a radiant warmer. When the
product is switched between incubator and radiant warmer operation, patients
continue to be kept warm during the transition. The device provides a thermally
regulated environment for patients with a body weight of up to 5 kg (11 lbs) and a
height of up to 55 cm (22 in). The device can be operated as either a closed care
unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator.
Neonates are kept warm in the patient compartment with humidifiable air, which can
be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant
warmer.
2.2 Indications
The IncuWarmer Babyleo TN500 provides controlled ambient conditions for
premature babies and neonates. The following parameters are regulated, according
to the intended use:
– Temperature
– Humidity
– Oxygen (option)
2.3 Contraindications
Do not use Babyleo TN500 outside the specified environments of use.
2.4 Environments of use
Babyleo TN500 provides controlled ambient conditions for premature babies and
neonates in a hospital. Babyleo TN500 is intended for use in the following
environments:
– Labor and delivery units
– Labor and delivery rooms
– Neonatal intensive care units
– Operating rooms
Babyleo TN500 is intended for use in the following environments where some of the
functions described under intended use are restricted (no active warming therapy,
humidification, and oxygen enrichment). For further information, see the following
chapter: ''Intrahospital patient transfer with switched off warming
therapy'' (page 150)
– During intrahospital patient transfer
Babyleo TN500 is not intended for use in the following environments:
– Home use
– Transport vehicles, e.g., ambulances, airplanes, or helicopters
– MRI environment
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