helena V8 NEXUS Operator's Manual page 105

7.3.3
7.3.4
7.3.5
V8 Operator Manual
external power supplies). This warranty shall be fulfilled by the repair or replacement, at the option of Helena Biosciences Europe, of
any part or parts, free of charge including labour, F.O.B. it's factory or authorised service centre.
This warranty shall be voided by any repair, alteration, or modification, by persons other than employees of Helena Biosciences
Europe, or those expressly authorised by Helena Biosciences Europe to perform repairs, and by any abuse, misuse, or neglect of the
product, or by use not in accordance with Helena Biosciences Europe's published instructions.
Helena Biosciences Europe reserves the right to make changes in design and / or improvements to its products without any
obligation to include these changes in any products previously manufactured. Correction of defects by repair or replacement shall
constitute fulfilment of all warranty obligations on the part of Helena Biosciences Europe.
THIS WARRANTY IS EXPLICITLY IN LIEU OF OTHER EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. THIS WARRANTY OBLIGATION IS
LIMITED TO REPAIR OR REPLACEMENT OF THE UNIT RETURNED TO HELENA BIOSCIENCES EUROPE OR AN
AUTHORISED SERVICE CENTRE FOR THAT PURPOSE.
WEEE
As of the 19th February 2007, Helena Biosciences Europe products meet the European Union Waste Electrical and Electronic
Equipment (WEEE) directive. Please refer to www.helena-biosciences.com for more information on Helena Biosciences compliance
with the WEEE directive.
When supplied as B2B EEE the producer invokes regulation 12.2 and passes all WEEE obligations to the end user.
Applicable standards and directives
The V8 capillary electrophoresis instrument complies with the relevant clauses and articles of the following recognised standards and
directives for its development, manufacture and servicing.
2014/35/EU Low Voltage Directive
98/79/EC In Vitro Diagnostic Medical Devices Directive
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6:
EN 61326-2-6:2013
Particular requirements – In vitro diagnostic (IVD) medical equipment
2014/32/EU Measuring Instruments Directive
BS EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use
BS EN Safety requirements for electrical equipment for measurement, control, and laboratory use:
61010-2-101:2002 Particular requirements for in vitro diagnostic (IVD) medical equipment
Safety requirements for electrical equipment for measurement, control and laboratory use: Particular
EN 61010-2-081:2015
requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
2011/65/EU Restriction of Hazardous Substances in Electrical and Electronic Equipment Directive
ISO 13485:2003
Medical Devices -- Quality Management Systems
EN ISO 13485:2012
ISO 9001:2008 Quality Management Systems
ISO 14971:2012 Medical Devices -- Application of Risk Management to Medical Devices
2012/19 /EU WEEE Directive
2014/30/EU Electromagnetic Compatibility Device
EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use – EMC requirements. Part 1: General
requirements
EN 61000-3-2:2014 Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current emissions
(equipment input current ≤ 16 A per phase)
EN 61000-3-3:2013 Electromagnetic compatibility (EMC) – Part 3-3: Limits – Limitation of voltage changes, voltage
fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16 A per
phase and not subject to conditional connection
47 CFR Part 15 subpart FCC
B (10-1-14)
2006/95/EU Electrical safety requirement
For instruments that will be sold in the United States of America, all relevant federal regulations of the Food and Drug Administration
(FDA) Title 21CFR have been complied with.
Precautions and limitations
1. To fully isolate the system remove the mains power cord from the rear of the instrument. This should be easily accessible by the
operator in the event of an emergency.
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