Product Manual

MN078-1 Rev K
25
EMC SUMMARY: IMMUNITY TEST RESULTS PERFORMANCE CRITERIA
Criteria During Test After Test
A
Operate as intended
No Degradation of performance
No loss of function
Operate as intended
No degradation of performance
No loss of function
B
Loss of function (one or more) Operate as intended
No degradation of performance
Functions self-recoverable
C
Loss of function (one or more) Operate as intended
No degradation of performance
Functions recoverable by the operator
* Applicable to all life support equipment and any equipment with less than 1 kVA input power, equipment with input power
above 1 kVA and below 16A per phase need only meet criteria B.
Note (1)- N/A – No I/O Ports;
Note (2) - N/A – Power did not have ground
Note (3): IMMUNITY FAILURE CRITERIA TO BE APPLIED
(a) If O2 concentration is above 87% and the alarm turns ON, this will be considered a nuisance
alarm and not a failure, because the percent of concentrated oxygen being delivered to the
patient is at or above specification.
(b) If the EUT resets during testing for EN61000-4 -2 thru -11 Immunity testing it is acceptable. The
concentration (%O2) will drop momentarily during the rest condition. The system should recover
and return to its previous concentration level.
(c) A reset has occurred when the system restarts by turning on its 4 waste/feed valves, the O2
alarm LED and the audible alarm for 4 seconds. The compressor may also turn off momentarily.
The EUT is expected to recover with no performance degradation
This device provides physician recommended oxygen therapy.
Source testing: ULTRATECH GROUP OF LABS File #: IEC 60601-1-2: 2007 (3rd EDITION) – Immunity for Medical Electrical Equipment
AIR095 & 116-EN601-1-2 Elite 120v 60 Hz, January, 2014
AIR-116_EN 60601-1-2_Elite 230v 50Hz, January, 2014,