Disposal Of The Packaging; Manufacturer's Declaration; Regulatory Information; Standards And Regulations - Zeiss VISUFIT 1000 Platform User Manual

Manufacturer's declaration

B2B
Name
RENE AG
Address Steinrinnenweg 6,
87745 Eppishausen, Germany
It is of the personal responsibility of you, as the user to delete any personal data before disposal of the
device. At the end of the product's service life, the lamps and installed batteries must be removed from
the device and properly disposed according to the EU guidelines separately.

10.2 Disposal of the packaging

The disposal of the product packaging is carried out according to national regulations. In accordance with
the regulations of the German Packaging Act, the Carl Zeiss Vision fulfills the obligation to collect used,
empty packaging that does not bear the mark of a nationwide waste disposal system (e.g. "Green Dot" or
"RESY" symbol).
For further information on disposal of the product packaging and if you would like to make use of this
possibility, please contact the Carl Zeiss Vision GmbH or your local distributor.
11 Manufacturer's declaration
Please note that any serious incident that has occurred in relation to the device should be reported to
the manufacturer and the competent authority of the Member State in which the user and/or patient
is established.
VISUFIT 1000 Platform may only be operated and used for its intended use and in accordance with:
•
country-specific provisions,
• generally recognized rules of technology and
• principles of occupational health and safety.

11.1 Regulatory information

This device fulfills the Medical Device Regulation (MDR) 2017/745.
Medical Device Class: I
UMDNS No.: 17-960
GMDN: 60723
EMC and ICES-003: Refer to the chapter 9 / 11.3
This statement is rendered null and void by changes to the product that are not authorized by the
manufacturer.

11.2 Standards and regulations

VISUFIT 1000 Platform fulfils the requirements of the following standards and regulations:
• Directive 2011/65/EU and Delegated Directive 2015/863
Restriction of the use of certain hazardous substances in electrical and electronic equipment
(RoHS)
Carl Zeiss Vision GmbH
EN_20_070_0018I_V1.8_VISUFIT 1000 Platform_20211213
B2C
REMONDIS Elektrorecycling GmbH
Brunnenstraße 138,
44536 Lünen, Germany
31