REPLIGEN CTech FlowVPX System - Table 3. Regulatory Information

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DOC0211
eRev. 1.08/15/2023
User Guide
CTech™ FlowVPX® System
4. Regulatory
Table 3. Regulatory information
CE Compliance
CE Compliance for the FlowVPX instrument is indicated by the following:
• The CE marking on the rear of the FlowVPX Head
• Repligen’s Analytics business document: CTech FlowVPX CE Declaration of Conformity CTIDC-0002
CE Compliance for the Beams System is indicated by the following:
• The CE marking on the bottom of the Beams Controller
• Repligen’s Analytics business document: Declaration of Conformity, CTech Beams System CTIDC-0005
CE compliance covers the FlowVPX Head, Detector, Fibrette® Optical Component, Repligen’s Analytics business-provided power
supply, three-meter cabling, and smart technology installed in every Flow Cell or System Suitability Adapter that mates with the
FlowVPX Head, Beams Source, and Beams Controller. FlowVPX installations utilizing cabling longer than three meters and/or
customer-provided 24 VDC power through the I/O cable have not been tested for CE compliance.
The CTech FlowVPX and Beams™ System have been designed and tested for compliance by independent testing laboratories in
accordance with the standards listed on the Declaration of Conformity documents listed above.
Under IEC 61010-1, the system is rated for measurement category I. Do not use this equipment for measurements within categories
II, III, and IV.
The FlowVPX System falls into pollution degree 2 as defined in IEC 61010-1.
Mains Supply
A power supply and location-specific power cord has been provided with the system. CE compliance and expected instrument
performance have only been tested with the following components.
Symbol Description
CE Compliance
The CE marking (conformité européenne, or “European conformity”) certifies that a product has met EU health,
safety, and environmental requirements, which ensure consumer safety.
UKCA
Compliance
The United Kingdom Conformity Assessment (UKCA) marking is used for products being placed on the market in
Great Britain and applies to most products for which the CE marking could be used.
KC Certification
Korea Certification (KC) is a product certification which ensures the conformity of products to Korean safety
standards. The KC mark is similar to the CE mark in the EU but involves different requirements and testing.
Hazardous
Locations
Compliance
(C1D2)
—
Hazardous Locations are areas where flammable liquids, vapors, gases, or combustible dusts are likely to occur
in quantities sufficient to cause a fire or explosion. A Class 1 (C1) location involves the presence of flammable
vapors or gases. A Division 2 (D2) location indicates that hazardous material is present only under abnormal
conditions.
IP65 Certification
The International Electrotechnical Commission (IEC) has developed ingress protection (IP) ratings, which grade
the resistance of an enclosure against the intrusion of dust or liquids. An IP65 Rating indicates that the product
has the highest level of dust protection and is able to withstand low-pressure water jets from all directions.
WEEE
Compliance
The EU has developed rules on waste from electrical and electronic equipment (WEEE) to steer manufacturing
towards sustainable production and consumption. The rules address environmental and other issues caused by
discarded electronics.