2
Safety
In case of complaints and events in connection with the medical device, please inform Renfert
immediately. Renfert will investigate the matter and report serious incidents to the authorities in
the Member States concerned.
2.1
Intended Use
This appliance is to be used exclusively for the professional cleaning of removable dentures as well as
orthodontic appliances and splints�
The appliance is designed for non-sterile use only�
2.2
Improper Use
Only spare parts and accessories supplied or authorized by Renfert GmbH may be used with this prod-
uct. If other spare parts or accessories are used, this could have a detrimental effect on the safety of the
device, increase the risk of serious injury and lead to damage to the environment or the device itself�
In particular, only use cleaning agents distributed by Renfert GmbH� If any other cleaning agents are
used, the results of the cleaning cannot be guaranteed and this may damage parts of the unit�
2.3
Ambient Conditions for Safe Operation
The device may only be operated:
• Indoors,
• Up to an altitude of 2,000 m above sea level,
• At an ambient temperature of between 5 - 40 ºC [41 - 104 ºF] *),
• At a maximum relative humidity of 80 % at 31 ºC [87�8 ºF], dropping to a linear of up to 50 % relative
humidity at 40 ºC [104 ºF] *),
• With mains power where the voltage fluctuations do not exceed 10 % of the nominal value,
• Under contamination level 2 conditions,
• Under over-voltage category II conditions�
*) Between 5 - 30 ºC [41 - 86 ºF] the device can be operated at a relative humidity of up to 80 %� At temperatures
between 31 - 40 ºC [87�8 - 104 ºF] the humidity must decrease proportionally in order to ensure operational readi-
ness (e�g� at 35 ºC [95 ºF] = 65 % humidity, at 40 ºC [104 ºF] = 50 % humidity)� The device may not be operated at
temperatures above 40 ºC [104 ºF]�
2.4
Ambient Conditions for Storage and Transport
For storage and transport the following specifications to ambient conditions apply:
• Ambient temperature - 20 – + 60 ºC [- 4 – + 140 ºF]�
• Maximum relative humidity 80 %�
2.5
Hazard and Warning Information
2.5.1
General Information
► If the device is not used in compliance with the supplied instructions, the safety of the device can
no longer be guaranteed.
► Only to be used indoors. The device is only intended for dry operation and should not be used or
stored outdoors or in wet conditions.
► The device may only be operated using a mains cable with the country-specific plug system. Any
necessary alterations must be carried out by a qualified electrician.
► The device may only be operated if the information on the identification plate conforms to the
specifications of your local mains power supply.
► The device may only be plugged into outlets which are connected to the protective conductor
system.
► The mains plug must be easily accessible.
► Disconnect the device from the mains before carrying out work on the electrical parts.
► Pull out the mains plug to disconnect the equipment from the mains supply. Detachable power
cords must not be replaced with inadequately rated power cords.
► Only use original Renfert replacement parts.
► Detachable power cords must not be replaced with inadequately rated power cords.
Only use original Renfert replacement parts.
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