Ec Declaration Of Conformity; Safety; Proper Use; Ambient Conditions For Safe Operation - Kulzer Dynamix speed Instrucciones De Uso

12

EC declaration of conformity

We, Kulzer GmbH, hereby declare that the present product:
Dynamix speed
Item no.: 66045779
complies with the following European directives:
− 93/42/EEC, Medical Devices Directive
2

Safety

Using these operating instructions as a starting point, instruct all operators of the unit with regards 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.
21

Proper Use

The Dynamix speed is designed solely for the extrusion of 2-component dental impression materials.
The Dynamix speed works with 5 : 1 cartridges or tubular bags in reinforcing cartridges from various manufacturers.
Dynamic mixing nozzles with hexagonal head drives are used for mixing.
Only the mixing nozzles and other system parts (e.g. fixation ring, supporting cartridges etc.) specified
by the impression material manufacturer may be used. The use of other mixing nozzles and system parts may
cause malfunction.
Always comply with all safety and processing instructions provided by the manufacturer!
Only the mixing nozzles specified by the manufacturer may be used.
22

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°C [41 – 104°F] *
for reaching optimum product properties of the impression materials the temperature requirements are valid from those
manufacturers. Please also see chapter 4.1.3. Setup Recommendations;
– At a maximum relative humidity of 80% at 31°C [88°F], dropping in a linear manner to 50% relative humidity
at 40°C [104°F] * ) ;
– With mains power where the voltage fluctuations do not exceed 10% of the nominal value;
)
;
66045779
Item no.:
GB
- 3 -