User Manual: Easy DR
ODB-100-5070ENG
5
Rev.:17-04-2020
Preface
Identification
Manuals are identified by a part number.
The part number is printed at the bottom of the title page. Numbers printed on
other pages are for internal revision control and may differ.
CE Classification
Manuals made for products that have been CE (Conformité Européenne) marked
have the CE mark on the front page. The number behind the CE Mark defines the
responsible notified body.
Oldelft Benelux B.V. systems are classified according to IEC 60601-1 as Class I,
type B. Oldelft Benelux B.V. systems meet the relevant provisions of the European
Medical Device Directive 93/42/EEC; this is based on conformity of the products
and the quality system according to ISO 13485:2016.
Symbols
Symbol
Meaning
Remarks
Location:
Near or on
the type identification
plate.
Symbol for separated collection of
electrical and electronic equipment
per Directive 2002/96 of the
European Parliament and the
Council of the European Union
(Directive on Waste of Electrical
and Electronic Equipment -
WEEE
).
If applicable to the type of device,
it indicates legally imposed
obligations within EU member
states, Iceland, Norway and
Switzerland when the equipment is
disposed of, at the end of its life-
time.
Owners of marked equipment
should contact the organization that
imported the equipment into their
country, when they want to dispose
of the equipment, at the end of its
lifetime. The Directive prioritizes re-
use of equipment over re-use of
components over re-use of
materials over disposal as waste.
Article 5 part 2d allows producers to
decline the return of any used
equipment that is or may be
biologically or radiologically
contaminated.
Legal manufacturer