A‐8Specifications ExpressionMR400InstructionsforUse
Cardiotach
Sensitivity(Monitorfiltermode) Adultpatienttype:>200μV
Neonate/Pediatricpatienttype:>100μV
QRSDuration Adultpatienttype:70to120ms
Neonate/Pediatricpatienttype:40to120ms
Bandwidth(Monitorfiltermode) 0.5to40Hz
BaselineOffset Automaticallyremoved
TallT‐WaveRejectionCapabilityforHeartRate
Indication
2mVwitha1
mVQRSamplitude(Monitormode)
Leads‐offSensing DetectionbyDCcurrentwavef ormof<100nA,notapplied
Alarm Limits (HR)
Lower
Upper
Off,or30to250BPM
60to250BPM,oroff
Test/Calibrations
SquareWaveTestSignal 60BPM±1BPM,1mV±10percent
ECG Supplemental Information, as required by IEC 60601-2-27
HeartRate(HR)AveragingMethod Fifteen‐pointmedianfilteremployedwheretheBPMheartrateis
computedbytakingthemeanofthe threemiddleelements.
Updaterateofthedisplayis2Hz.
TimetoAlarmforTachycardia
B1‐VentTachycardia
1mVpp,206BPM
B2‐VentTachycardia
2mVpp,195BPM
Gain0.5
(12.03,11.04,14.1,11.8,11.4)Average:12.1sec(The
monitoringsystemmaytemporarilyexitthealarmcondition
duringthearrhythmiawaveformduration.)
Gain1.0(11.9,11.6,9.2,9.6,10.9)Average:10.6seconds
Gain2.0(8.8,9.1,10.3,9.4,12.1)Average:9.9seconds
Gain0.5(9.0,10.4,12.3,8.1,10.4)Average:10.0seconds
Gain1.0(8.4,7.7,12.5,7.7,8.3)Average:8.9seconds
Gain2.0(9.7,12.6,8.9,11.8,8.3)Average:10.3seconds
Measurements made in FILTER MODE - MONITOR, outside of the MR environment. The alarm condition response
time of some arrhythmia complexes may be affected by MRI gradient artifacts.
ResponseTimeofHeartRateMetertoChange
inHeartRate
HRchangefrom80to120BPM:8.3secaverage
HRchangefrom80to40BPM:7.9secaverage
ECG