14423-INS-LAB-RevD11 6
WARNINGS
WARNING:FederalLaw(USA)restrictsthisdeviceto
salebyorontheorderofaphysician.Thisproduct
shouldnotbeusedunlesstheoperatorhasbeenin-
structedbyaqualiedhealthcareprofessional.
WARNING:DonotusetheGrafcoPocketDopplerina
ammableatmospherewhereconcentrationsofam-
mableanestheticsorothermaterialsmayoccur.
WARNING:Donotexposebatteriestoheat.
WARNING:Donotattempttochargealkalinebatter-
ies;theymayleakorcatchonre.
WARNING:DONOTsimultaneouslytouchsignalin-
putoroutputconnectorandthepatient.
WARNING:Accessoryequipmentconnectedtothe
analoganddigitalinterfacesmustbecertiedaccord-
ingtotherespectiveIECstandards(e.g.IEC950for
dataprocessingequipmentandIEC60601-1formedi-
calequipment).Furthermoreallcongurationsshall
complywiththevalidversionofthesystemstan-
dardIEC60601-1-1.Anyonewhoconnectsadditional
equipmenttothesignalinputconnectororsignal
outputconnectorconguresamedicalsystem,andis
thereforeresponsiblethatthesystemcomplieswith
therequirementsofthevalidversionofthesystem
standardIEC60601-1-1.Ifindoubt,consultyourGF
HealthProducts,Inc.authorizeddistributor.
WARNING:TheGrafcoPocketDopplerisatooltoaid
thehealthcareprofessionalandshouldnotbeusedin
placeofnormalfetalmonitoring.
WARNING:Exposuretoultrasoundshouldbekeptas
lowasreasonablyachievable.Thisisconsideredto
begoodpracticeandshouldbeobservedatalltimes.
WARNING:Replacethebatteryatleast6feet(1.5me-
ters)fromthepatient.