300004969171/B Page 129 of 148
Catheters and Guide Wire
SmartWire II (guide wire)
6603J, 6613, 6613J
7900, 7900J, 7903,
7903J, 7913, 7913J
PrimeWire PRESTIGE (guide wire)
PrimeWire PRESTIGE Plus (guide wire)
10185, 10185J, 10300,
10300J
Standards and Regulations
The Volcano System Series of Precision Guided Therapy Systems complies with the
requirements of these standards and requirements:
Medical electrical equipment – General requirements for safety
IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012
ANSI/AAMI ES60601-1:2005+A2 (R2012) +A1
IEC 60601-2-37:2007
IEC 60601-2-34:2011
CAN/CSA C22.2 No. 60601-1-14
The Volcano system FFR Option does not comply with Clause 51.102.1 since the guide
wire’s pressure transducer can drift over extended periods of time. It is important that the
guide wire’s reading be verified every 10 minutes and normalized to the aortic reading if
drift has occurred. The Volcano system FFR Option is not intended for long-term (hours)
invasive pressure monitoring but rather is a diagnostic instrument for measuring pressure
during catheterization procedures.
Medical electrical equipment – Electromagnetic compatibility
IEC 60601-1-2:2014
SYMBOL: Declaration of Conformity:
We declare that the Volcano system series of Precision Guided Therapy Systems meets
the requirements of the Medical Device Directive 2007/42/EC for Electromagnetic
Compatibility (EMC) through the use of International Standard IEC/EN 60601-1-2 and
complies with the following standards:
To Next Page
Loading...
General