User's Manual

ENGLISH – 17
The SMARTVIEW monitor may be interfered with by
other equipment, even if that other equipment
complies with CISPR emission requirements.
12. DATA PROTECTION
Any clinical data is fully secured with restricted access. You have the
right to access this information at any time and ask for any change by
request only. Please contact your doctor or our toll-free technical
assistance.
13. DECLARATION OF CONFORMITY
Sorin declares that this device conforms to the following Product
Specifications:
Safety - IEC 60601-1:2005 (Ed. 3) - Medical electrical equipment - Part 1:
General requirements for basic safety and essential performance.
EMC - IEC 60601-1-2:2007 (Ed. 3) - Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility - Requirements and Tests.
EN 50371:2002 - Generic standard to demonstrate the compliance of low
power electronic and electrical apparatus with the basic restrictions related
to human exposure to electromagnetic fields (10 MHz - 300 GHz).
EN 50385:2002 - Product standard to demonstrate the compliance of
radio base stations and fixed terminal stations for wireless
telecommunication systems with the basic restrictions or the reference
levels related.
EN 301 489-1 v1.8.1 - Electromagnetic compatibility and Radio
spectrum Matters (ERM); Electromagnetic Compatibility (EMC)
standard for radio equipment and services. Part 1: Common technical
requirements.