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

1 User information
Damage of the device by ingress of liquids
The secretion aspirator Allegra M30 has the IP classification IP22
against the ingress of liquids. Nevertheless, protect the device from moisture.
• Do not use the device near splashing water.
• Do not use the device in damp rooms or while bathing or showering.
• 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, bathrooms or showers. Avoid
wet conditions on power supply unit, control panel and socket for the
power supply unit.
EN
• Ensure that fluff and dust are immediately removed from the device incl.
accessories, in order to ensure unimpaired functionality. Furthermore no
52 pests may be allowed in the proximity of the device, as there is a risk they
may get inside the device causing damage.
• 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 pro-
vided by Heinen + Löwenstein GmbH & Co. KG or an authorized distribution
partner of Heinen + Löwenstein GmbH & Co. KG. Product training takes ap-
proximately one to two hours and, 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 instruction for use,
• the device is opened by unauthorized personnel,
• the safety seal is removed/broken,
• installation, settings, enhancements, routine maintenance or repairs are
performed 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.

1.9 Material compatibility

Aggressive substances can damage the device and the
accessories.
Follow the instructions for cleaning and care (see section 4.1 resp. 4.2).
1 User information
EN
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