8 Technical Data
8.2 Classification and safety standards
Page 82
Art. no.: 0-48-0013 Rev. m
FRED easy
8.2 Classification and safety standards
Display
Type
Dimensions
High-resolution LCD screen, electroluminescent backlighting, text and symbol display
100 x 37 mm
Standards
FRED easy® complies with IEC standard 60601-2-4.
According to IEC standard 60601-2-4, FRED easy® is a device for frequent use.
EMC
See 8 Technical Data.
Compliance
• FRED easy® bears the (Notified Body LNE/G-MED) mark indicating its
compliance with the provisions of the Directive 93/42/EEC (modified by the Direc-
tive 2007/47/EEC) regarding medical devices and fulfils the essential require-
ments of Annex I of this directive.
• FRED easy® is a class IIb device.
Patient Protection
BF type, resistant to defibrillation shocks.
Explosions protection
FRED easy® is not designed to be used in the presence of flammable mixtures of
anaesthetic agents with air or oxygen.
The SCHILLER quality management system complies in full with the international
standards ISO 9001 and ISO 13485.
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