Edwards HemoSphere

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HemoSphere Advanced Monitor 2 Safety and Symbols
2.6 Applicable Standards
2.7 HemoSphere Advanced Monitor Essential Performance
The platform shall provide display of continuous CO and intermittent CO with a compatible Swan-Ganz
catheter according to the specifications provided in appendix A. The platform shall provide display of
intravascular blood pressure with a compatible FloTrac or FloTrac IQ sensor or compatible TruWave DPT
according to the specifications provided in appendix A. The platform shall provide display of SvO
2
/ScvO
2
with a compatible oximetry catheter according to the specifications provided in appendix A. The platform
shall provide alarm, alert, indicator, and/or system status when unable to provide accurate measurement of
the applicable hemodynamic parameter. For more information, see Essential Performance Characteristics on page
189.
Table 2-3 Applicable standards
Standard Title
IEC 60601-1:2005 / A1:2012 Medical electrical equipment — Part 1: General requirements for basic
safety and essential performance + amendment 1 (2012)
IEC 60601-1-2: 2014 Medical electrical equipment — Part 1-2: General requirements for basic
safety and essential performance — Collateral standard:
Electromagnetic compatibility - Requirements and tests
IEC 60601-2-34: 2011 Medical electrical equipment — Part 2-34: Particular requirements for
the basic safety and essential performance of invasive blood pressure
monitoring equipment
IEC 60601-2-49:2011 Particular requirements for the basic safety and essential performance of
multifunction patient monitoring equipment
IEEE 802.11 b/g/n Telecommunications and information exchange between systems Local
and metropolitan area networks — Specific requirements Part 11:
Wireless LAN Medium Access Control (MAC) and Physical Layer (PHY)
Specifications
Status = Released Printed Date: 2018-01-16 Released Date: 2017-09-14