Safety; 2�1 Intended Use; 2�2 Improper Use; 2�3 Ambient Conditions For Safe Operation - Renfert PROMIX one Mode D'emploi

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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
The equipment is only to be used for the mixing of capsules from Dentsply Sirona:
• Surefil one™
• Calibra Bio
®
Comply with the enclosed directions for using the capsules�
See Technical Data for the mixing time and mixing frequency�
2.2 Improper use
Mixing of capsules from other manufacturers can cause unsatisfactory mixing results and thereby inade-
quate quality of the filling material.
Using other capsules not named in section 2�1 is prohibited�
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
equipment, increase the risk of serious injury and lead to damage to the environment or the product itself�
2.3 Ambient conditions for safe operation
The equipment may only be operated:
• Indoors,
• Up to an altitude of 2,000 m above sea level,
• At an ambient temperature of between 18 - 30 ºC [64�4 - 86 ºF] *),
• At a maximum relative humidity of 80 % at 31 ºC [87�8 ºF], linear reduction up to 50 % relative humidity
at 30 ºC [86 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�
2.4 Ambient conditions for storage and transport
For storage and transport the following specifications for ambient conditions apply:
• Ambient temperature - 20 – + 60 ºC [- 4 – + 140 ºF],
• Relative humidity 10 % – 96 %�
• Air pressure 70 kPa – 105 kPa�
2.5 Hazard and warning information
2.5.1 General information
► If the equipment is not used in compliance with the supplied instructions, the safety of it can no
longer be guaranteed.
► The equipment may only be operated using a power cord with the country-specific plug system.
Any necessary alterations must be carried out by a qualified electrician.
► The equipment may only be operated if the information on the rating plate conforms to the specifi-
cations of your local mains power supply.
► The mains plug must be easily accessible.
► Disconnect the equipment from the mains before carrying out work on the electrical parts.
► Pull out the mains plug to disconnect the equipment from the mains supply.
► It is the responsibility of the operator that national regulations during operation and regarding a
repeated safety inspection of electrical equipment are complied with.
For Germany these are MPBetreibV in relation to DIN EN 62353 (VDE 0751).
► Check connection cables (such as power cords), tubes and housing (i.e. the key-pad) regularly, at
least once a week, for damage (i.e. kinks, cracks and porosity) or signs of ageing.
Do not operate equipment with damaged connection cables, hoses or housing parts or other de-
fects!
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