22
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 62535, 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 < 1000 µA, discharge current at
applied part < 1000 µA.
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 62535,
which otherwise would have to be
ordered by the user.
Accessories
Art. No.
Description
0970
Foot switch
3497
Spray filter
4571
Protection washer
6475
Tool for washer
8555
AquaHy
The clamping system is designed
for rotating instruments, which have
a shaft of 2,35mm in accordance
with ISO EN ISO 179-1.
