User Requirements; Information On Product Liability - Asskea proVisio M28 Gebrauchsanweisung

Damage to the device by ingress of liquids
The ASSKEA proVisio ®
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.
• Never submerge the device in water or other liquids (including while it is switched off).
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 proVisio
by instructed and appropriately trained persons. Familiarize yourself with the
operation of the ASSKEA proVisio
Training on how to handle the ASSKEA proVisio
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 optional disinfection, as well as the procedure to be followed for each new
patient and for disposal.

2.8 Information on product liability

The liability for the operation of the device is transferred to the operator in the following cases:
• the device is used beyond the scope of 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, processing or repairs are performed by unauthorized
personnel;
• original accessories and spare parts have not been 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.
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M28 secretion aspirator has the IP classification IP22 against the
M28 secretion aspirator may be operated and used only
®
M28 secretion aspirator prior to startup.
®
® M28 secretion aspirator is provided by