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4 Intended use of the device
Instrument for the measurement of binocular and monocular refraction based on infrared
photorefraction.
5 Classification and Applied Standards
5.1 Classification according MDD 93/42/EEC, Annex IX
Class IIa
5.2 Classification and type of applied parts
When used without the KALEIDOS accessory, there are no applied parts.
When used in the 2WIN-S configuration, with the KALEIDOS accessory, the applied part is
Class I, Type B.
5.3 IP classification
IPX0 (degree of protection provided by the external plastic shells with reference to the
penetration of any special material or water).
5.4 Electromagnetic compatibility
This device has been classified as class B according to the standard IEC 60601-1-2.
5.5 Applied standards
EN 60601-1; EN 60601-1-2; EN ISO 15004