Classification And Safety Standards - Schiller FRED easy User Manual

8 Technical Data
8.2

Classification and safety standards

Display
Type
Dimensions
Standards
EMC
Compliance
Patient Protection
Explosions protection
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High-resolution LCD screen, electroluminescent backlighting, text and symbol display
100 x 37 mm
8.2 Classification and safety 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.
See 8 Technical Data.
• FRED easy® bears the
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.
BF type, resistant to defibrillation shocks.
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.
(Notified Body LNE/G-MED) mark indicating its
FRED easy