
33
Appendix D
Regulatory notices
This product has been designed and manufactured to meet the intent of U.S., Canadian, and European regulatory
requirements as outlined below. Modifications made to this product that are not expressly approved in writing by the
manufacturer will void the user’s authority to operate this product, previously issued factory approvals, and the user’s
rights under the warranty.
The distributor or dealer may have applied additional local, national, or international approvals to this product. Consult the
distributor or dealer for more information and documentation.
Connections to this product must be made with shielded cables. Use of non-shielded cables may violate RFI/EMI limits.
Regulatory approval type
Description
U.S. Safety
This product conforms to UL 61010-1:2012 Ed.3., “Safety Requirements for Electrical Equipment for
Measurement, Control, And Laboratory Use - Part 1:General Requirements.”
This product conforms to UL 61010-2-101 Issued: 2015/08/14 Ed: 2., “Safety Requirements for
Electrical Equipment for Measurement, Control, and Laboratory Use – Part 2-101: Particular
Requirements For In Vitro Diagnostic (IVD) Medical Equipment.”
The "US” in the lower right of the ETL mark demonstrates these listings.
Canadian Safety
This product is certified to CSA C22.2#61010-1-12:2012 Ed.3, “Safety Requirements for Electrical
Equipment for Measurement, Control, And Laboratory Use Part 1:General Requirements”
This product is certified to CSA C22.2#61010-2-101:2015 Ed.2.,” Safety Requirements for Electrical
Equipment for Measurement, Control, and Laboratory Use – Part 2- 101: Particular Requirements for In
Vitro Diagnostic (IVD) Medical Equipment.”
The "C” in the lower left of the ETL mark demonstrates these listings.
Europe
Low Voltage Directive
This product conforms to 2014/35/EU Low Voltage Directive
Europe
Electromagnetic Compatibility
Directive
2014/30/EU
This product conforms to Directive 2014/30/EU. Compliance is demonstrated by using the following
standards as listed in the Official Journal of European Communities.
•
IEC 61326-1 ed. 2: 2012 – Electrical equipment for measurement, control, and laboratory use - EMC
requirements - Part 1: General requirements.
•
IEC 61326-2-6 ed. 2: 2012 – Electrical equipment for measurement, control, and laboratory use -
EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment.
Europe
Restriction of the Use of
Certain Hazardous Substances
in Electrical and Electronic
Equipment (RoHS)
201
1
/
65
/EU
This product meets the intent of Directive 201
1
/
65
/EU for “Restriction of the Use of Certain
Hazardous Substances in Electrical and Electronic Equipment.” Compliance is demonstrated by
using the following standards as listed in the Official Journal of European Communities.
•
EN IEC 63000:2018: Technical documentation for the assessment of electrical and electronic
products with respect to the restriction of hazardous substances.
FCC Part 15 Subpart B 2017/05
This device complies with Part 15 of the FCC Rules.
Canada
ICES-003
This Class A digital apparatus complies with Canadian ICES-003.
Japan
VCCI V-3/2012
This Class A digital apparatus complies with VCCI technical requirement V-3.
CB Certificate
A copy of certificate is available on request
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