C.S.O. srl - Costruzione Strumenti Oftalmici with headquarters in V. Degli Stagnacci 12/e - 50010 Badia a Settimo - Firenze – Italia, manu-
facturers of the medical electrical device (Class I, as per Directive 93/42/EEC) denominated
CHART PROJECTOR
MODEL: CP 2047, CP 2147, CP 1042, CP 1142, CP 2033, CP 3000, CP 3137,
in the person of its legal representatives Sergio Mura and Giuseppe Matteuzzi,
who assume full personal liability for the following,
WHO ASSUMES
full personal liability for the following, hereby certifies
- complies fully with the following EU directive, including the latest amendments, and with the relative national implementing legislation:
DIRECTIVE 93/42/EEC “MEDICAL DEVICES ” of 14 June 1993
and that
- the following harmonized standards were applied:
•
EN 60601-1 - “MEDICAL ELECTRICAL EQUIPMENT – PART 1: GENERAL REQUIREMENTS FOR SAFETY" as amended, corresponding to
Italian standard CEI 62-5 - 2005 edition
•
EN 60601-1-2 - “MEDICAL ELECTRICAL EQUIPMENT – PART 2: Collateral Standard: Electromagnetic Compatibility,” corresponding
to Italian standard CEI 62-50 – 2001 edition;
•
UNI EN ISO 8596 (1996) “Visual Acuity Test Types. Standard Optotype and its Presentation.”
•
UNI EN ISO 8597 (1996) “Visual Acuity Test Types. Method for Correlating Optotypes.”
•
ISO 10938: (1998) “Ophthalmic Instruments. Chart Projectors.”
- The instrument is marketed with the mark attesting to compliance with the above-mentioned directives.
SCANDICCI (FIRENZE), 28/09/06
The legal representatives of CSO Srl
(Sergio Mura and Giuseppe Matteuzzi)
.......………………….............................
STATEMENTS OF COMPLIANCE
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