22
Technical Details
Operating Time
The device is designed for extend-
ed usage.
Ambient Conditions
The device is intended for use in
dry closed rooms.
Operation:
temp.: +10°C to +26°C
rel. humidity: 25% to 75%
(not condensed)
air pressure: 700 hPa to 1060 hPa
Storage:
temp: -5°C to +55°C
rel. humidity: 10% to 95%
(not condensed)
air pressure: 500 hPa to 1060 hPa
Transport (up to 4 weeks):
temp: -5°C to +55°C
rel. humidity: 10% to 95%
(not condensed)
air pressure: 500 hPa to 1060 hPa
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: II
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, suc-
tion/spray, clamping 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 <500µA, discharge current at
applied part <500µA
Functional inspection of display,
on/off-button, suction/spray, speed
and clamping system. Safety and
function 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.
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.
