User Manual for LCO-i100 Console
www.levitronix.com
PL-4066-00, Rev05, DCO# 24-013
This document and its content are confidential and the property of Levitronix
®
and shall not be reproduced, distributed,
disclosed or used for manufacturing or sale of Levitronix
®
products without the expressed written consent of Levitronix
®
.
9 Appendix
9.1 Regulatory Status
9.1.1 CE and UKCA Marking
We herewith declare that the PuraLev
®
Console LCO-i100, in its configurations as listed below is in conformity with the
below described European Directives and UK Statutory Instruments. The console is thought to be used in laboratory and
industrial production environment of Life Science markets like Biotech and Pharmaceuticals.
LCO-i100.x-yy with x = various hardware configuration options and yy = various firmware options.
Consoles with 24 VDC for up to 160W supply input.
Note: The standard specified AC/DC power supplies for 50 and 160W are commercially available NRTL certified components.
Compatible CE certified IPD-30.x drivers (24 VDC) of the PuraLev
®
i30SU pump system.
Compatible CE certified IPD-100.x drivers (24 VDC) of the PuraLev
®
i100SU pump system.
Compatible CE certified IPD-600.x drivers (48 VDC) of the PuraLev
®
i600SU pump system.
Single-Use DCP-30.x pump heads of the PuraLev
®
i30SU pump system.
Multi-Use LPP-30.x pump heads of the PuraLev
®
i30MU pump system.
Single-Use DCP-200.x pump heads of the PuraLev
®
i100SU pump system.
Multi-Use LPP-200.x pump heads of the PuraLev
®
i100SU pump system.
Single-Use DCP-600.x pump heads of the PuraLev
®
i600SU pump system.
Clamp-on flow sensors of the LEVIFLOW
®
LFSC-D and LFSC-iX and LFSC-X.1 Series.
Single-Use sensors of the LEVIFLOW
®
LFS-SU Series.
Various signal adaptor cables for LEVIFLOW
®
flow sensors.
Machinery Directive 2006/42/EU – Machinery Regulation SI 2008 Nr. 1597:
The machinery directive/regulation essentially has been followed by a risk analysis, according mitigation actions and a
user manual for safe operation. For the design and testing the following standards are used as a guideline:
Safety for machinery – principles for risk assessments: used for system risk analysis.
Degree of protection provided by enclosure (IP code).
Low Voltage Directive 2014/35/EU – Low Voltage Regulation SI 2016 Nr. 1101:
The low voltage directive/regulation essentially has been followed by a risk analysis, electrical safety testing and a user
manual for safe operation. For the design and testing the following standards are used as a guideline:
Safety requirements for electrical equipment: tested at certified 3
rd
party laboratory.
Fulfilled by the specified standard commercially available AC/DC powers supplies.
Safety for machinery – principles for risk assessments: used for system risk analysis.
EMC Directive 2014/30/EU – EMC Regulation SI 2016 Nr. 1091:
The following standards of the EMC directive/regulation are tested and confirmed:
Electrical equipment for measurement, control and laboratory use – EMC requirements
9.1.2 IECEE CB Safety Certification
The Levitronix
®
LCO-i100 Console is 3
rd
party tested and certified by Electrosuisse following the IECEE CB
Scheme according to the following safety standards:
Safety requirements for electrical equipment for measurement, control and laboratory use.
9.1.3 NRTL/ETL Safety Certification and Marking
The Levitronix
®
LCO-i100 Console is tested by the US national recognized laboratory (NRTL) Intertek according to the
following safety standards:
Safety requirements for electrical equipment for measurement, control and laboratory (US Standard).
CSA-C22.2, No. 61010-1-12
Safety requirements for electrical equipment for measurement, control and laboratory use (Canadian Standard).
9.1.4 Disposal of Equipment – WEEE Directive 2012/19/EU
Follow local legislation for disposal of equipment. In the European Union (EU) marked ( ) devices are governed by the
European WEEE Directive 2012/19/EU. Do not dispose with normal waste.