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Rev. 3.0
10
BM3 User’s Manual
Patient Classification
BM3 monitors are designed for use by adults, pediatrics and neonates. At this time,
cardiac output, ST segment analysis and arrhythmia should be used for adults and
pediatrics only.
Functional safety
The essential performance of the patient monitor is to provide the clinician with
meaningful parameter values and to sound an alarm when the established parameter
value is exceeded or the function that provides the value is not working properly. We
assessed the risks associated with the use of these monitors in light of these essential
performance features and mitigated the risk of lowering the residual risk to a level that
could be used without compromise as long as the product maintained its regular
lifecycle maintenance and service recommendations.
