Dräger caleo - Intended Use; Restrictions of Use

Intended Use
19
Operating Instructions Caleo, Software 2.n
Applications
Restrictions of Use
Intended Use
Applications
Caleo
®
is an infant incubator system for premature babies and
sick infants up to a body weight of 5 kg (11 lbs) or a body
length of 55 cm (22 inches), providing a controlled environment
of warmth, humidity*, and elevated O
2 concentration* in the
patient area. The total body weight when treating twins is
limited to 5 kg (11 lbs).
Caleo
is intended for use in clinical environments where
premature babies or infants are treated who require a
controlled climatic environment.
Options for nursing and therapy:
– Convective heat therapy through control of incubator air
temperature or infant skin temperature
– Humidification of the incubator air
–O
2 therapy through controlled elevation of the O2
concentration in the patient environment
– Nursery and intensive care via access ports or two large
access doors
– Pivoting bed for raising and lowering the infant’s head
(Trendelenburg and anti-Trendelenburg position)
With monitoring for:
– Air temperature
– Skin temperature
– Relative humidity
–O
2 concentration
– Weight*
WARNING !
This device may only be used by properly trained
personnel under the supervision of qualified medical
personnel familiar with the currently known risks and
benefits of using an infant incubator.
* Available option
WARNING !
Dräger cannot warrant or endorse the safe performance
of third party accessories for use with the Caleo
incubator system.
Only use accessories that are qualified to the required
specifications for an intended use in an oxygen enriched
environment.
Restrictions of Use
CAUTION !
Restriction of Distribution
Federal Law (U.S.) restricts this device to sale by or on the
order of a physician.
CAUTION !
Device for use in health care facilities only and exclusively by
persons with specific training and experience in its use.
WARNING !
This device is to be used only in rooms with line power
installations complying with national safety standards
for hospital patient rooms (e.g., IEC/EN 60601-1 "Medical
Electrical Equipment - General Requirements For
Safety").
To maintain grounding integrity, connect only to a
"hospital grade" receptacle.
Always disconnect supply before servicing.
WARNING !
DANGER, risk of explosion if used in the presence of
flammable anesthetics.
This device is neither approved nor certified for use in
areas where combustible or explosive gas mixtures are
likely.
WARNING !
The use of this device requires continuous supervision
of the infant by trained nursing personnel in order to
ensure immediate corrective action in situations with a
risk of patient injury.