Renfert 276100 0000, Manual

Page: 17 / 360

2 Safety
Using these operating instructions as a starting point, instruct all operators of the unit with regard
to the area of application, the possible hazards during operation, and the proper operation of the
unit.
Please have these operating instructions readily available for the operators�
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 Proper Use
The duomix II is designed solely for the extrusion of 2-component precision impression materials�With the
duomix II it is possible to use 5:1 cartridges or pouches in support cartridges from various manufacturers�
Dynamic mixing nozzles with hex drive are used to mix the material�
Always comply with all safety and processing instructions provided by the manufacturer!
Only the mixing nozzles specified by the manufacturer may be employed.
2.2 Ambient conditions for safe operation
Safe operation of the unit can only be ensured under the following ambient conditions:
-Indoors;
-Up to an altitude of 2,000 m above sea level;
-At an ambient temperature range between 5 - 40 ºC [41 - 104 ºF] *);
-At a maximum relative humidity of 80 % at 31 ºC [88 ºF], dropping in a linear manner 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 – 40 °C [41 – 104 °F], the unit can be operated at a relative humidity of up to 80 %� At temperatures
between 31 – 40 °C [88 – 104 °F], the humidity must decrease proportionally in order to ensure operational read-
iness (e�g�, at 35 °C [95 °F] = 65 % humidity; at 40 °C [104 °F] = 50 % humidity)� The unit may not be operated at
temperatures above 40 °C [104 °F]�
2.3 Ambient conditions for storage and transport
Ensure the following ambient conditions during storage and transport:
-Ambient temperature - 20 – + 60 ºC [- 4 – + 140 ºF],
-Maximum relative humidity 80 %�
2.4 Hazard and Warning Information
2.4.1 General Information
► 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.
► The device may only be plugged into outlets which are connected to the protective conductor
system.
► The mains plug must be easily accessible.
► Pull out the mains plug to disconnect the equipment from the mains supply.
► Check connection cables (such as power cords), tubes and housing (i.e. the key pad) regularly for
damage (i.e. kinks, cracks and porosity) or signs of ageing. Do not operate equipment with dam-
aged connection cables, hoses or housing parts or other defects!
► The equipment may only be operated if the information on the identification plate conforms to the
specifications of your local mains power supply.
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