Advanced Bilirubin Stat-Analyzer BR2, Service Manual, Page: 12 / 69

The Advanced® Model BR2 Service Manual
12
U.S. Safety This product has been listed by ETL
testing laboratories as being in compli-
ance with the requirements of UL
61010-1 2nd edition, "Electrical
Equipment for Laboratory Use”. The
"US" in the lower right of the ETL
mark demonstrates this listing.
Canadian Safety This product has been listed by ETL
testing laboratories as being in compli-
ance with the requirements of
CAN/CSA C22.2 No. 61010-1 2nd
edition, "Safety Requirements for
Electrical Equipment for Measure-
ment, Control and Laboratory Use”.
The "C" in the lower left of the ETL
mark demonstrates this listing.
EC Declaration of This product meets the intent of
Conformity - EMC Directive 2004/108/EC for
Electromagnetic Compatibility.
Compliance was demonstrated using
the following standards, as listed in the
Official Journal of the European
Communities: Consult the Declaration
of Conformance certificate shipped
with the product for the latest update.
• EN 61326-1:2006, Group 1, Class
B, "Electrical Equipment for
Measurement, Control, and
Laboratory Use".
EC Declaration of: This product meets the intent of
Conformity - Low Directive 2006/95/EC, the Low
Voltage Voltage Directive. Compliance was
demonstrated using the following stan-
dards as listed in the Official Journal
of the European Communities:
Consult the Declaration of
Conformance certificate shipped with
the product (if required) for the latest
update.
· IEC/EN 61010-1 2nd edition,
"Safety Requirements for Electrical
Equipment for Measurement,
Control and Laboratory Use”.
· IEC 61010-2-101 (2002-01) -
“Safety Requirements for Electrical
Equipment for Measurement,
Control, and Laboratory Use; Part 2-
101: Particular Requirements for In
Vitro Diagnostic (IVD) Medical
Equipment, First Edition”.
EC Declaration of This product meets the intent of
Conformity - IVD Directive 98/79/EC for In Vitro
Diagnostic Medical Devices. Consult
the Declaration of Conformance certifi-
cate shipped with the product (if
required) for the latest update.
Regulatory
approval type Description
Regulatory
approval type Description
EC Declaration of This product does not meet the
Conformity - WEEE intent of Directive 2012/19/EU for
“Waste Electrical and Electronic
Equipment” (WEEE) due to the presence
of a restricted material, lead (> 0.1%), in
some of the electronic components used.
Instruments delivered prior to July 22,
2016 were in compliance with the ruiles
in effect at that time.
EC Declaration of This product does not meet the
Conformity - RoHS intent of Directive 2011/65/EU for
“Restriction of the Use of Certain
Hazardous Substances in Electrical and
Electronic Equipment” (RoHS) due to the
presence of a restricted material, lead
(> 0.1%), in some of the electronic com-
ponents used. Instruments delivered prior
to July 22, 2016 were in compliance with
the rules in effect at that time.
FCC - Part 15, This device complies with Part 15
Subpart B, Class B of the FCC Rules. Operation is subject
to the following two conditions: (1) this
device may not cause harmful interfer-
ence, and (2) this device must accept any
interference received, including interfer-
ence that may cause undesired operation.
Canadian ICES-003 This Class B digital apparatus complies
with Canadian ICES-003.
Cet appareil numérique de la classe
B est conforme à la norme NMB-003 du
Canada.
CB Report A CB report and certificate have
CB Certificate been issued for this product. The standard
used was IEC 61010-1, 2nd edition and
61010-2-101, 1st edition.
U.S. FDA Listing The Bilirubin Test System, along with the
calibrators and controls manufactured by
Advanced Instruments, are listed with
U.S. Department of Health and Human
Services, Food and Drug Administration,
as:
Bilirubin Test System Class 2
Calibrators Class 2
Controls Class 1
Health Canada The Bilirubin Test System, along with
License the calibrators and controls manufactured
by Advanced Instruments, are licensed
with Health Canada, Therapeutic
Products Directorate, Medical Devices
Bureau, as:
Bilirubin Test System Class 2
Calibrators Class 2
Controls Class 2