The OsmoPRO
®
Micro-Osmometer Service Manual
Regulatory
approval type Description
CE Declaration of: This product meets the intent of
Conformity - Low Directive 2014/35/EU, the Low
Voltage Voltage Directive. Compliance
was demonstrated using the fol-
lowing standards as listed in the
Official Journal of the European
Communities: Consult the
Declaration of Conformance cer-
tificate shipped with the product
(if required) for the latest update.
· EN 61010-1, "Safety
Requirements for Electrical
Equipment for Measurement,
Control and Laboratory Use,
General Requirements".
· EN 61010-2-101, "Safety
Requirements for Electrical
Equipment for Measurement,
Control and Laboratory Use -
Part 2-101, Particular
Requirements for In Vitro
Diagnostic (IVD) Medical
Equipment”.
FCC - Part 15 This device complies with Part 15
Subpart B, Class B of the FCC Rules. Operation is
subject to the following two condi-
tions:
(1) This device may not cause
harmful interference.
(2) This device must accept any
interference received, including
interference that may cause unde-
sired operation.
Canadian This Class B digital apparatus
complies with Canadian ICES-003.
ICES-003 Cet appareil numérique de la classe
B est conforme à la norme NMB-
003 du Canada.
Japan VCCI This Class B digital apparatus
complies with VCCI technical
requirement V-3.
EC Declaration of This product meets the intent of
Conformity - WEEE Directive 2012/19/EU for Waste
Electrical and Electronic
Equipment (WEEE). Consult the
Declaration of Conformance cer-
tificate shipped with the product
(if required) for the latest update.
Regulatory
approval type Description
EC Declaration of This product meets the intent of
Conformity - RoHS Directive 2011/65/EU for
“Restriction of the Use of Certain
Hazardous Substances in Electrical
and Electronic Equipment.”
EC Declaration of This product meets the intent of
Conformity - WEEE Directive 2002/96/EC as amended
by 2003/108/EC for Waste
Electrical and Electronic
Equipment (WEEE). Consult the
Declaration of Conformance cer-
tificate shipped with the product
(if required) for the latest update.
CB Certificate A copy of the certificate is avail-
able upon request.
U.S. FDA Listing The osmometer, along with the cal-
ibrators and controls manufactured
by Advanced Instruments, are list-
ed with the U.S. Department of
Health and Human Services, Food
and Drug Administration, as:
Osmometer Class 1
Calibrators Class 2
Controls Class 1
The osmometer, along with the cal-
ibrators and controls manufactured
by Advanced Instruments, are
licensed with Health Canada,
Therapeutic Products Directorate,
Medical Services Bureau as:
Osmometer Class 2
Calibrators Class 2
Controls Class 2
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