25
Technical Details
Compulsory Registration
Operators, distributors and retailers
who were informed about the occur-
rences regarding §29 of the Medical
Devices law must report this. The
method of reporting is detailed in
the Medical Devices Safety Plan
Ordinance. Outside of Germany the
corresponding local conditions ap-
ply.
Safety Check
A
safety check must be done in
compliance with the regulations of
the country where the device is
used. The inspection interval is
once a year.
Repeated control and control after
repair (DIN EN 62353, VDE 0751-1)
Inspection interval for repeated
control: 1 year
Technical Information:
Safety class: I
Application: Type B (separate
measuring of discharge current not
necessary)
Power connection: NPS (non-
detachable power connection)
The protective ground conductor is
not connected to touchable conduc-
tive parts.
Necessary
function
inspection:
speed, display, on/off, spray, clamp-
ing system.
Inspection before use
During the production control the
following inspections as per DIN EN
62353 (VDE 0751-1) are conducted
among others:
Optical control, unit discharge cur-
rent <1000µA, discharge current at
applied part <1000µA
Functional inspection of display,
on/off button, spray, speed and
clamping system. Safety and func-
tion deficiencies have not been
found. By providing this information
an inspection before use can be
renounced as per DIN EN 62353,
which otherwise would have to be
ordered by the user.
Disposal
The device and filter may
contain infectious material
such as residual sanding
dust or skin particles. Therefore,
please bear in mind the following
disposal instructions.
Disposing of the device
Old devices bought in Germany that
correspond to the electronic device
law should be sent directly to the
manufacturer (hadewe). We will
dispose of the device free of
charge. The devices should not be
taken to public disposal plants
(WEEE Reg. No. DE20392713, b2b
device). For disposal of this unit out
of Germany, please contact the site
where you bought this hadewe
product.
