Dantec Clavis User Guide
20
Safety & Standards Conformity
Standards of Compliance and Normative References
The Dantec Clavis System is powered by a 9V battery with the following levels of protection:
1.
Type of protection against electric shock: Class II
2.
Degree of protection against electric shock: Type BF
3.
Degree of protection against ingress of water, IPX1
4.
Degree of safety of application in the presence of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
5.
Mode of operation: Continuous
6.
Environmental Conditions: Normal: 10-40°C, 30-75% rH, 700-1060hPa
The Clavis System and its accessories have been designed to comply with the following national and
international standards:
Table 1
–
Safety Standard of Compliance and Normative References
CAN /CSA-C22.2 No. 60601-1: 08(R2013) +
C2:2011
ANSI/AAMI ES60601-1:2005/(R)2012 +
C1:2009/(R)2012 and A2:2010/(R)2012
IEC 60601-1:2005 + C1:2006 and C2:2007,
Third Edition
CENELEC EN 60601-1:2006 + A1:2013
Medical electrical equipment – Part 1: General
requirements for basic safety and essential
performance
IEC 60601-1-6:2010, Edition 3.0 + A1:2013
Medical electrical equipment – Part 1-6: General
requirements for basic safety and essential
performance – Collateral standard: Usability
IEC 62366:2007, Edition 1.0
Medical devices – Application of usability
engineering to medical devices
IEC 60601-2-40:2016
Medical electrical equipment - Part 2-40: Particular
requirements for the basic safety and essential
performance of electromyographs and evoked
response equipment
