Page 11 of 38
User requirements
1.7
The
ASSKEA secretion aspirator proVisio
®
M28
may only be operated and used
by instructed and appropriately trained persons. Familiarize yourself with the
mode of operation of the
ASSKEA secretion aspirator proVisio
®
M28
prior to
startup.
Training on how to handle the
ASSKEA secretion aspirator proVisio
®
M28
is provided by
ASSKEA GmbH or an authorized distribution partner of ASSKEA GmbH. Product training takes
approximately 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.
The training should be repeated regularly every 24 months.
Each participant receives a certificate as proof of training.
Information on product liability
1.8
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,
the device is used beyond its lifetime of 3 years.
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.
Material compatibility
1.9
Aggressive substances can damage the device and the accessories.
Follow the instructions for cleaning and care (see section 4.1 resp. 4.2).
