Dürr Technik SICOLAB med, Installation And Operating Instructions Manual

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1018100100L02 1907V005
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Important information
Installation and repairs
i
Always arrange for any assembly work, read-
justments, alterations, extensions, and repairs
to be performed by Dürr Technik or by per-
sonnel authorised and trained by Dürr Tech-
nik. Qualified personnel are defined as those
trained by Dürr Technik; who are familiar with
the unit technology; and are aware of the dan-
gers presented by the unit.
2.5 Electrical safety
i
Observe and comply with all the relevant elec-
trical safety regulations when working on the
unit.
i
Replace any damaged cables or plugs imme-
diately.
2.6 Essential performance charac-
teristics
The SICOLAB med unit does not have any es-
sential performance characteristics in accord-
ance with EN/IEC 60601-1 section 4.3. The unit
is classified as
not life-sustaining . An adequate
replacement supply must be provided for the
supply of a life-sustaining ventilator.
2.7 Notification requirement of seri-
ous incidents
The user / patient is required to report to the
manufacturer and the competent authority of
the Member State, in which the user and/or pa-
tient is established, any serious incident that has
occurred in relation to the device.
2.8 Only use original parts
i
Only use accessories and special accessories
that are specified or approved by Dürr Tech-
nik.
i
Only use original working and spare parts.
i
Ensure that the unit operator has access to
the Installation and Operating Instructions at
all times.
Should the user connect additional units
to the respiratory air compressor, the re-
sulting system is a medical device sys-
tem.
It is the responsibility of the user to make
sure that the medical device system
meets the requirements of IEC 60601-1.
WARNING
The supply pressure of life-sustaining
ventilators is too low.
Should the respiratory air compressor
supply the respirator unit with an insuffi-
cient amount of compressed air, this
can result in a pressure drop in the ven-
tilator and insufficient air supply to the
patient.
i
The ventilator must have a suitable
alarm signal.
WARNING
Malfunction of the device due to
portable and mobile RF communica-
tion units (electromagnetic interfer-
ence)
Portable and mobile RF communication
units (including antennae cable and ex-
ternal antennae) generate electromag-
netic fields. This can result in malfunc-
tion of the unit.
i
Keep a minimum distance of 30 cm
between the unit (including power
cord) and RF communication unit /
accessories.
2.4 Specialist personnel
Operation
Unit operators must ensure safe and correct
handling based on their training and knowledge.
i
Instruct or have every operator instructed in
the handling of the unit.
EN