GE CARESCAPE ONE - J Electromagnetic compatibility; Essential performance in EMC

J
Electromagneticcompatibility
IEC60601-1-2
ThesystemcomplieswithIEC60601-1-2:2007-03.
Accordingtoparameter-specicIEC60601-2-xseriesstandardrequirementsforESU
(electrosurgicalunit)tests,theequipmentisprotectedagainstmalfunctioncaused
byelectrosurgery.
EssentialperformanceinEMC
Parameter
Essentialperformance
General●Nolossofdisplayorusersettings.
●Nolossofpatientdata,modeofoperation,orstoreddataduringlossofACmains
orbatterypower>10s.
●Noinvalidorerroneousalarms.
●Abilitytogenerateatechnicalalarmduringabnormaloperation.
ECG
●Nofalsebeatdetectionthatproducesanincorrectheartratemeasurementgreater
than±10%or±5bpm,whicheverisgreater.
●Nowaveformamplitudeerror>20%.
Impedance
respiration
●Noerrorinrespirationrategreaterthan±1breathperminute.
Invasiveblood
pressure
●Noinvasivepressureerrorgreaterthan±4%ofreadingor±0.5kPa(±4mmHg),
whicheverisgreater.
Temperature
●Noerrorsintemperaturereadings>0.3°C.
CO
2
(RGM)
●NoerrorinCO
2
greaterthan±(volumefractionof+8%ofGasLevel)withthegas
levelsetbetween71-100mmHg..
●Nochangeinrespirationgreaterthan±1breathperminute.
●CO
2
owrate<60ml/min.
SpO
2
:GETruSignal,
Nellcor,Masimo
●Noerrorsinpulserategreaterthan±2bpmforGETruSignalSpO
2
orgreaterthan
±3bpmforNellcorandMasimoSpO
2
.
●Noerrorinsaturationgreaterthan±4%.
Non-invasiveblood
pressure
●Noerrorforthemeasurementofthecuffpressuregreaterthan±2mmHg(±0.3kPa).
Debrillatorsync
markeroutput
●TimedelayfrompeakofECGR-wavetosynchronizationpulse≤35ms.
2094480-001CARESCAPEONE387
CARESCAPE ONE User Manual DRAFT 26 October 2017