User's Manual

25
15.0 Standards
The Vpatch System has been designed and tested to conform to the essential requirements
and provisions of European Council Medical Devices Directive 93/42/EEC Annex II (excluding
Section 4) for a Class IIa device, (under Annex IX Rule 10 – non-invasive active device),
obtaining the European CE Mark.
The device has been designed to conform to the following International Standards:
IEC 60601-1 :
2005/AMD1:2012/COR1:2014
ISO 14971:2012 BS EN 980:2008
IEC 60601-1-2 :2014 EN 1041 : 2008 BS PD IEC TR 60878:2003
IEC 60601-1-6 : 2010+AMD1: 2013 ANSI/AAMI EC57:2012 EC38 : 1998
IEC 60601-1-11:2015 BS EN 60529: 1992
AAMI EC 12:2000 (R2015) ISO 15223-1:2016
EN 60950-1 : 2001 plus amendments
A11:2004
ISO 13485 2016
Table 8
16.0 Warranty
Medical Manufacturers products are warranted to be free from manufacturing and material
defects for a period of 1 year from the date of shipment by the manufacturer to the distributor
or directly to the health care professional workplace.
Excluded from this warranty are the CR3032 Lithium Coin Cell Batteries and the Mascot
Battery Charger.
Any repairs made to the product that are not covered by the warranty shall be billed to the
customer.
For service or technical support contact your distributor.