Edwards EV1000

Safety and Symbols
2-9
Applicable Standards
EV1000 NI Essential Performance
The system shall provide noninvasive measurement of
arterial blood pressure according to the specification*. The
system shall provide alarm, alert, indicator, and/or system
status when unable to provide accurate measurement of the
above parameter.
 The Essential Performance specification refers to the
finger cuff blood pressure stated in Appendix A:Table A-3,
"Base Parameters" on page A-2.
Documentation and Training
Available documentation and training for the EV1000
Clinical Platform NI includes:
• EV1000 Clinical Platform NI Operator’s Manual
• EV1000 Clinical Platform NI Instructions for Use
Instructions for Use are included with EV1000 Clinical
Platform NI components. See Table A-4, “EV1000 Clinical
Platform NI Components,” on page A-2. For more
information on how you can receive training or available
documentation for the EV1000 Clinical Platform NI, contact
your local Edwards Representative or Edwards Technical
Support. See Appendix E: System Care, Service and Support.
Warehouse Storage Humidity Limitations
(X = lower limit, Y = upper limit)
Transport and Storage Atmospheric Pressure
Limitations
(X = lower limit, Y = upper limit)
Table 2-3 Applicable Standards
Standard Title
IEC 60601-1:2005
(3
rd
ed)
Medical electrical equipment - Part 1:
General requirements for basic safety
and essential performance + Correction
AC:2010
IEC 60601-1-2: 2007 Medical electrical equipment - Part 1-2:
General requirements for basic safety
and essential performance- Collateral
standard: Electromagnetic compatibility
- Requirements and tests
IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6:
General requirements for basic safety
and essential performance - Collateral
standard: Usability
IEC 60601-1-8:2006 Medical electrical equipment - Part 1-8:
General requirements for basic safety
and essential performance-Collateral
Standard: General requirements, tests
and guidance for alarm systems in
medical electrical equipment and
medical electrical systems
IEC 60601-2-49:2011 Medical electrical equipment
Part 2-49: Particular requirements for
the basic safety and essential
performance of multifunction patient
monitoring equipment.
IEC 60601-2-57:2011 Medical electrical equipment - Part 2-
57: Particular requirements for the
basic safety and essential performance
of non-laser light source equipment
intended for therapeutic, diagnostic,
monitoring and cosmetic/aesthetic use
ISO 13485:2003/
AC:2009
Medical devices - Quality management
systems - Requirements for regulatory
purposes
IEC 62366:2007 Medical devices - Application of
usability engineering to medical
devices
ISO-10993-1:2009 Biological evaluation of medical
devices - Part 1: Evaluation and testing
within a risk management system
ISO 14971:2007 Medical devices - Application of risk
management to medical devices
Table 2-2 Symbols on Product Labels (Continued)
Symbol Description
ISO 15223-1:2012 Medical devices - Symbols to be used
with medical device labels, labelling
and information to be supplied - Part 1:
General requirements
IEC 62471:2008 Photobiological safety of lamps and
lamp systems
AAMI ES 60601-1:
2006
Medical Electrical Equipment,
Part 1: General Requirements for Basic
Safety and Essential Performance; with
AMD C1; 2009, AMD 2; 2010, AMD 1;
2012.
CSA C22.2#60601-1:
2008
Medical electrical equipment - Part 1:
General requirements for basic safety
and essential performance; COR 2:
2011/06/01.
Table 2-3 Applicable Standards (Continued)
Standard Title