Bionet BM1, Руководство пользователя

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Rev. 2.2
9
Patient Classification
BM1 monitors are designed for use by adults, pediatrics and neonates.
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.