User Requirements; Information On Product Liability - Asskea M Serie Gebrauchsanweisung

2 User information
Possible physiological effects and unobvious risks
• Select the vacuum depending on the respective patient and on the
medical indication to avoid personal injuries.
• Never use the ASSKEA secretion aspirators M- and S-series to aspi-
rate solids or inhaled foreign objects out of the throat. This could
lead to the object being pushed deeper into the airways potentially
causing total obstruction.
• Always place the device upright on a sturdy and flat base without
slope. Make sure that the device cannot be knocked over or fall in
such a way that persons could be hit by the falling device.
• Other devices, examinations or treatments may be influenced by the
device. For this reason, special attention should always be paid to
other devices as well as to examinations and treatments performed
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in parallel so that any effect is detected as quickly as possible.
• When using the device, adequate lighting must always be ensured so
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that all labels can be identified clearly.
• Small, detached parts could be inhaled or swallowed. Therefore
ensure that no unauthorized persons, children or pets are near the
device.
• Although the materials used have been tested for compatibility, in
exceptional cases allergic reactions to the exposed materials on the
device and the accessories may occur. This applies especially for
contact injuries after prolonged exposure. In such cases, consult a
doctor immediately.
Contact of the interior of the device with liquids and solids
If the interior of the device comes into direct contact with liquids or
solids, the device must be inspected by ASSKEA GmbH or by a service
partner authorized by ASSKEA GmbH.

2.7 User requirements

The ASSKEA secretion aspirators M- and S-series must only
be operated and used by instructed and appropriately trained
persons. Familiarize yourself with the mode of operation of the
ASSKEA secretion aspirators M- and S-series prior to start-up.
Training on how to use the ASSKEA secretion aspirators M- and S-series
is provided by ASSKEA GmbH or an authorized distribution partner
of ASSKEA GmbH. Product training includes, among other things, an
explanation of the design and function of the device, handling of the
device, cleaning and disinfection as well as the procedure to be follo-
wed for each new patient and for disposal.
Training should be repeated regularly every 24 months.
Each participant receives a certificate as proof of training.

2.8 Information on product liability

Liability for the operation of the devices is transferred to the operator
in the following cases:
• if the device is used for a purpose other than its intended use,
• if the device is not used in accordance with the instruction for use,
• if the device is opened by unauthorized personnel,
• if the safety seal is removed / broken,
• if installation, settings, enhancements, processings or repairs are
performed by unauthorized personnel,
• if incorrect accessories or spare parts are used.
The assembly of ME systems and modifications during their
expected service life must be evaluated again based on the
requirements of the applicable standards.