each technical alarm) Current SpO2 Output[j] Current monitored value of SpO2 displayed on SpO2 monitoring device front panel SpO2 Limit Output[j] Auditory and visual notification of violation of SpO2 Alarm limit alarm on SpO2 monitoring device front panel Notification SpO2 Technical Output[j] (fill in description of technical alarms) Alarm Notifications (fill in – create a new row for each technical alarm) Current RR Output[j] Current monitored value of RR displayed on RR monitoring device front panel RR Limit Alarm Output[j] Auditory and visual notification of violation of RR Notification limit alarm on RR monitoring device front panel RR Technical Output[j] (fill in description of technical alarms) Alarm Notifications (fill in – create a new row for each technical alarm) PCA front panel and technical alarm information (fill in – create a new row for each displayed front panel value reported and each technical alarm). System Monitored Variables: External Entity: Clinician System Interaction Point: Devices – PCA Prescription Drug Name Input[k] Name of opioid to be infused Drug Input[k] Concentration of drug Concentration Loading Dose Input[k] Volume of initial dose of drug to be delivered at the
each technical alarm) Current SpO2 Output[j] Current monitored value of SpO2 displayed on SpO2 monitoring device front panel SpO2 Limit Alarm Notification Output[j] Auditory and visual notification of violation of SpO2 limit alarm on SpO2 monitoring device front panel SpO2 Technical Alarm Notifications (fill in – create a new row for each technical alarm) Output[j] (fill in description of technical alarms) Current RR Output[j] Current monitored value of RR displayed on RR monitoring device front panel RR Limit Alarm Notification Output[j] Auditory and visual notification of violation of RR limit alarm on RR monitoring device front panel RR Technical Alarm Notifications (fill in – create a new row for each technical alarm) Output[j] (fill in description of technical alarms) PCA front panel and technical alarm information (fill in – create a new row for each displayed front panel value reported and each technical alarm). System Monitored Variables: External Entity: Clinician System Interaction Point: Devices – PCA Prescription Drug Name Input[k] Name of opioid to be infused Drug Concentration Input[k] Concentration of drug Loading Dose Input[k] Volume of initial dose of drug to be delivered at the
ICE-PCA-MSIS-Mock-Vendor-Submission-v0.11.docx