Instructions for Use Neonatal Intensive Care System VARIOTHERM REA-KCE
D 2002_01.doc
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Normal use
The resuscitation and intensive care system VARIOTHERM is used for postnatal care and resuscitation,
warming care, oxygen therapy as well as intensive care of infants up to 12 kg weight. It is laid out for
continuous operation and conforms to the "Particular requirements for the safety of blankets, pads and
mattresses, intended for heating in medical use EN-60601-2-35" as well as the "Particular requirements for
the safety of infant radiant warmers EN 60601-2-21".
General safety instructions
The user must be thoroughly acquainted with this instruction for use. The resuscitation and intensive care
system must only be used under medical supervision by qualified instructed persons who are acquainted
with the use and risks of conductive warming devices and radiant warmers for infants.
If the device shall be used for another purpose than the normal use described above, this must not be done
without our written consent.
In order to guarantee the safe operation, the resuscitation and intensive care system should be subject to
regular preventive maintenance measures by authorized qualified persons. For normal operating conditions
we recommend yearly preventive maintenance intervals whereas under unfavourable ambient conditions
and in case of high-duty use half-yearly intervals should be observed. We can only be held responsible for
the safety features of this device when maintenance and modifications are carried out by authorized
qualified persons, by using original spare parts.
Transport and storage
For transport and storage the following conditions should be observed:
Temperature: 0°C to 70°C
Relative air humidity: 15 % to 95 %
Atmospheric pressure 900 to 1100 hPa
The device must not be exposed to strong vibrations.
Ambient requirements
The device can be used under the following operation conditions:
Temperature: 18°C to 30° C
Relative air humidity: 15 % to 95 %
Atmospheric pressure: 900 to 1100 hPa
This device is not suitable for the use in explosion-hazardous areas.
When using HF-surgery devices are applied, it should be observed that the under-pad heating consists of
electrically conductive material and that it is earthed.
Mobile telephones may interfere the function of electro-medical devices. Therefore no mobile telephones
should be used within a distance of 10 meters around the device.
It has to be considered that other heating sources, fans and cold walls may change the effect of the device.
Therefore a distance of 1 m should be kept clear and the bassinet should be protected from direct sunlight.
Furthermore the device should not be placed in draughts (e.g. air condition) and at windows. Fluids and
inflammable agents must not be brought into touch with the radiant warmer. In order to avoid the risk of fire
there must not be any inflammable material (e.g. curtains) within an area of 70 cm around the radiant
warmer.
