ExpressionMR400InstructionsforUseGettingStarted3‐11
•Alarmflagsrelatedtootheralarmsoundstateswillberemovedfromthedisplay.
•Analarmconditionnotpreviouslyplacedinanaudiooffstatewillcausethealarmto
sound.
Selecting the Patient Type
DeterminingthePatientType
IEC80601‐2‐30Edition1.0,theinternationalstandardregardingparticularrequirementsfor
safety,includingessentialper formanceofautomaticcyclingnon‐invasivebloodpressure
monitoringequipment,definespatienttypesintwocategories:neonatalandadult.Neonatal
patientsaredefinedbytheapproximateagerangeofbirthto
afewweeks.Allotherpatientsare
identifiedasadults.
ANSI/AAMISP10:2008,theAmericanNationalStandardformanual,electronic,orautomated
sphygmomanometers,definespatienttypesaccordingtoagelimitations,asindicatedinthetable
below.
Similarly,theFood&DrugAdministrationdefinespatientswithintwocategories:pediatricsand
adults.Eachcategory
isfurtherdefinedintosubgroupsaccordingtoapproximateage.
There may be occasions when a particular mode is not suitable for its apparent category of patients
based on age alone. In these cases, a clinical decision shall be made to use another patient type or
measurement technique. The clinical decision shall be based on all of the factors listed in
Determining the Patient Type (above) to ensure the best possible and most timely measurement
acquisitions.
Patient Type Age
Neonatal Birth to 28 days
Pediatric 29 days to 12 years
Adult Greater than 12 years
Patient Type Subgroup Approximate Age Range
Pediatric Newborn (neonate) Birth to 1 month
Pediatric Infant Greater than 1 month to 2 years
Pediatric Child Greater than 2 to 12 years
Pediatric Adolescent Greater than 12 to 21 years
Adult --- Greater than 21 years