Taylor-Wharton CS Series - Manual (Page 49)

47
CS SERIES
Declaration of Conformity
EC DECLARATION OF CONFORMITY
The undersigned representing the manufacturer
Pacer Digital Systems, Inc.
Attn: Kevin Oeff
8658 Castle Park Drive
Suite 103
Indianapolis, IN 46256
USA
Herewith declared that the Product: LN
2
Level Control for Cryostorage System
Model/Type ref.: CS CONTROL SYSTEM
is in conformity with the Essential requirements of the following EC Directives when
subject to correct installation, maintenance and use conforming to its(their)intended
purpose, to the applicable regulations and standards, to our operation and
maintenance manual.
93/42/EEC Medical Device Directive
2004/108/EC EMC Directive
2006/95/EC Low Voltage Directive
and that the Standards and/or technical specifications referenced below have been
applied:
• EN 60601-1:2006 Edition 3 Medical Electrical Equipment – General
Requirements for basic safety and essential performance.
• IEC 60601-1-2: 2007 Edition 3 Medical Electrical Equipment – General
Requirements for basic safety and essential performance – Collateral standard :
Electromagnetic Compatibility
• IEC/CISPR 11:2009+A1:2010 Radiated & Conducted Emissions.
• IEC61000-3-2:2005+A1:2008+A2:2009. Harmonics
• IEC 61000-3-3:2008. Flicker
Year of CE Marking: 2012
Manufacturer: Pacer Digital Systems, Inc.
Signature: Kevin Oeff Digitally signed by Kevin Oeff
DN: cn=Kevin Oeff, o=Pacer Digital Systems, Inc., ou,
[email protected], c=US
Date: 2012.05.24 13:48:04 -04’00’
Position: President
Date: 24 May 2012
Place: Indianapolis, IN USA
Warranty
Taylor-Wharton warrants that each of its electronic control products will be free
from defects in material and workmanship, in the normal service for which the
product was manufactured, for a period of two years from the date of purchase.
Taylor-Wharton at its option will either repair or replace any item covered under this
warranty.
This warranty is void if the product is used for any other purpose than that for which
it was designed, including but not limited to connection with third party systems.