local control very clear on the ICE system, it shall through front disable programming pump's state. through its front panel and panel Programming disabled display an appropriate to prevent possible message. The pump unintended interaction "pause" command shall between ICE system not be disabled. and clinician. # Rqmt ID Name Description Rationale To prevent unauthorized access The ICE Supervisor shall to the device provide means for an Configuration 7.3.1 CR_0000000001 settings that may authorized and privileged authorization lead to loss of user to configure key parameters on the device. important data or inaccurate data. PCA app implementations PCA trigger shall be able to trigger ICE 7.3.2 CR_0000000049 alarms system alarms and stop the infusion pump. The ICE system shall verify that it is receiving data from at least one source of Data devices for the following parameters: verification - 7.3.3 CR_0000000110 • Heart rate from at least one • Blood pressure app • Respiration rate • SpO2 • Pain score • Sedation score The Infusion Management Electronic Application shall have Medical Record 7.3.4 CR_0000000218 the capability to (EMR) Data request data from the Requests Electronic Medical Record (EMR). The Infusion Management EMR: Patient Application shall have Time is particularly important for neonatal 7.3.5 CR_0000000219 data and time of the capability to patients birth request and maintain patient date and time of birth. 7.3.6 CR_0000000220 EMR: Drug The Infusion
local control through front panel ICE system, it shall disable programming through its front panel and display an appropriate message. The pump "pause" command shall not be disabled. very clear on the pump's state. Programming disabled to prevent possible unintended interaction between ICE system and clinician. # Rqmt ID Name Description Rationale 7.3.1 CR_0000000001 Configuration authorization The ICE Supervisor shall provide means for an authorized and privileged user to configure key parameters on the device. To prevent unauthorized access to the device settings that may lead to loss of important data or inaccurate data. 7.3.2 CR_0000000049 PCA trigger alarms PCA app implementations shall be able to trigger ICE system alarms and stop the infusion pump. 7.3.3 CR_0000000110 Data verification - from at least one app The ICE system shall verify that it is receiving data from at least one source of devices for the following parameters: • Heart rate • Blood pressure • Respiration rate • SpO2 • Pain score • Sedation score 7.3.4 CR_0000000218 Electronic Medical Record (EMR) Data Requests The Infusion Management Application shall have the capability to request data from the Electronic Medical Record (EMR). 7.3.5 CR_0000000219 EMR: Patient data and time of birth The Infusion Management Application shall have the capability to request and maintain patient date and time of birth. Time is particularly important for neonatal patients 7.3.6 CR_0000000220 EMR: Drug The Infusion
ICE-PCA-MSIS-Mock-Vendor-Submission-v0.11.docx