GE CARESCAPE - BIS cautions

Bispectralindex
WARNING
Thismonitorusesacomponentmodulardeviceinderivingthe
Bispectralindex(BIS)purchasedfromCovidien.Itisimportant
torecognizethisindexisderivedusingsolelythatcompany’s
proprietarytechnology.Itisrecommendedthatclinicians
havereviewedapplicableinformationonitsutilityand/orrisks
inpublishedarticlesandliterature/websiteinformationfrom
Covidien(www.covidien.com)orcontactthatcompanyitselfif
theyhaveclinical-basedBISquestionsrelatingtothismodule
portionoftheGEmonitor.Failuretodosocouldpotentially
resultinincorrectadministrationofanestheticagentsand/or
otherpotentialcomplicationsofanesthesiaorsedation.We
recommendthatcliniciansalsoreviewthefollowingpractice
advisory(thatincludesasectiononBISmonitoring):The
AmericanSocietyofAnesthesiologists,PracticeAdvisoryfor
IntraoperativeAwarenessandBrainFunctionMonitoring
(Anesthesiology2006;104:847-64).Cliniciansarealso
recommendedtomaintaincurrentknowledgeofgovernment
regulatory,practiceorresearchinformationonBISand
relatedtopics.
WARNING
MisinterpretationofBIScanresultinincorrectadministration
ofanestheticagentsand/orotherpotentialcomplicationsof
anesthesiaorsedation.
BIScautions
CAUTION
Duetoelevatedsurfacetemperature,donotplacetheBIS
deviceinprolongeddirectcontactwiththepatient’sskin,asit
maycausediscomfort.
CAUTION
TheBISmeasurementbasedonmeasuringtheEEGsignalis
inherentlyverysensitive.Radiatedelectromagneticeldsmay
causeerroneousmeasurementsatvariousfrequencies.Do
notuseelectricalradiatingequipmentclosetotheBISxor
DSC.Detailsregardingradiatedeldstrengthsaregivenin
thetechnicalspecications.
CAUTION
Automaticsensorcheckmayneedtobedisabledifthe1
nA128Hzimpedancechecksignalinterfereswithother
equipment,suchasEEGmodulewithevokedpotentials
measurement.
CAUTION
TheBISmodulehasbeendesignedtooperatewitha
disposableBISsensor.Onlyuserecommendedsensors.
CAUTION
DonotusetheBISsensorifthesensorgelisdry.Toavoid
dryout,donotopenthepackuntilyouarereadytousethe
sensor.
CAUTION
Checkthesensorexpirationdateonthesensorpackage.Do
notuseexpiredsensors.
CAUTION
Ifskinrashoranyunusualsymptomdevelops,discontinuethe
BISmeasurementandremovethesensor.
394CARESCAPEModularMonitors2062971-001