Edwards HemoSphere - Specifications; A.1 Essential Performance Characteristics

A
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Appendix
Specifications
Contents
Essential Performance Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .189
HemoSphere Advanced Monitor Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .190
HemoSphere Battery Pack Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .192
HemoSphere Swan-Ganz Module Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .192
HemoSphere Pressure Cable Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .194
HemoSphere Oximetry Cable Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .194
A.1 Essential Performance Characteristics
Under normal and single fault conditions either the essential performance listed in table A-1 below is
provided or failure to provide this performance is readily identifiable by the user (e.g., no display of
parameter values, technical alarm, distorted waveforms or delay in parameter value update, complete failure
of the monitor, etc.).
Table A-1 represents the minimum performance when operating under non-transient electromagnetic
phenomena, such as radiated and conducted RF, according to IEC 60601-1-2. Table A-1 also identifies the
minimum performance for transient electromagnetic phenomena, such as electrical fast transients and
surges, according to IEC 60601-1-2.
Table A-1 HemoSphere advanced monitor essential performance – transient and non-transient electromagnetic
phenomena
Module or
cable
Parameter Essential Performance
General: all monitoring modes and parameters No interruption of current monitoring mode. No unexpected reboots
or halting of operation. No spontaneous triggering of events that
require user interaction to initiate.
Patient connections provide defibrillator protection. Following
exposure to defibrillation voltages, the system shall return to an
operational state within 15 seconds.
After the transient electromagnetic phenomena, the system shall
return to an operational state within 10 seconds. If Swan-Ganz
continuous cardiac output (CO) was active during the event, the
system will automatically re-initiate monitoring. The system shall
exhibit no loss of any stored data following the transient
electromagnetic phenomena.
When used with HF Surgical Equipment, the monitor shall return to
operational mode within 10 seconds without loss of stored data after
exposure to the field produced by the HF Surgical Equipment.
Status = Released Printed Date: 2018-01-16 Released Date: 2017-09-14