User Requirements; Information On Product Liability - Lowenstein Medical Allegra M30 Mode D'emploi

User information
• Do not use the device near splashing water.
• Do not use the device in damp rooms where humidity is >90 % (no condensation),
in the bath or when showering (risk of electric shock).
• Avoid wet conditions on power supply unit, control panel and socket for the
power supply unit.
• Never submerge the device in water or other liquids (also not while it is switched
off).
Known, identifiable or foreseeable conditions for medical care
within a domestic environment
• Children and pets should be kept away from the device. Make sure that the
device cannot be knocked over or fall in such a way that persons could be hit by
the falling device.
• Prior to connecting the power supply unit, ensure that the voltage of the device
corresponds to the domestic power supply.
• The device may not be used in damp rooms where humidity is >90 % (no con-
densation). Avoid wet conditions on power supply unit, control panel and socket
for the power supply unit.
• Ensure that fluff and dust are immediately removed from the device incl. acces-
sories, in order to ensure unimpaired functionality. Furthermore no pests may be
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allowed in the proximity of the device, as there is a risk they may get inside the
device causing damage.
11 • Never expose the device incl. accessories to direct sunlight as this could result in
a strong heating effect, causing functional impairments.
• Some devices and sources that are commonly used in the domestic
environment may cause potential faults in the device incl. accessories,
e.g. fireplaces or radiant heaters (strong heating of the device) resp. inhalers or
steam kettles (excessive air humidity). Do not operate such devices and sources
in the vicinity of the secretion aspirator Allegra M30.

1.7 User requirements

The secretion aspirator Allegra M30 may only be operated and
used by instructed and appropriately trained persons. Familiarize yourself
with the mode of operation of the secretion aspirator Allegra M30
prior to startup.
Training on how to handle the secretion aspirator Allegra M30 is provided
by Löwenstein Medical GmbH & Co. KG or an authorized distribution partner of
Löwenstein Medical GmbH & Co. KG. Product training, among other things, includes
an explanation of the design and function of the device, the handling of the device,
the cleaning and disinfection as well as the procedure to be followed for each new
patient and for disposal.

1.8 Information on product liability

The liability for the operation of the device is channeled to the operator in the
following cases:
• the device is used outside its intended use,
• the device is not used in accordance with the instructions for use,
• the device is opened by unauthorized personnel,
• the safety seal is removed/broken,
• installation, settings, enhancements, routine maintenance or repairs are per-
formed by unauthorized personnel,
• original accessories and spare parts have not been used.
Advice for the responsible organization:
The assembly of ME systems and modifications during their actual service life shall
be evaluated based on the requirements of the applying standards.