cell counts. capability to display complete blood cell counts. The patient monitoring Monitoring: system shall have the activated Partial capability to display 6.4.24 CR_0000000239 Thromboplastin activated Partial Time (aPPT) Thromboplastin Time (aPPT) The Operator shall have the Infusion capability to access patient 6.4.25 CR_0000000249 Management medical information and App medical history through the Infusion Management App. # Rqmt ID Name Description Rationale The ICE System shall 7.2.1 CR_0000000041 Pump status display the pump status at all times. The pump To ensure that the The pump shall conform 7.2.2 CR_0000000042 shall conform pump is compatible to {specify} standards. to standards. with the ICE system. PCA app implementations shall be able to receive information signals, such PCA as alarm signals, 7.2.3 CR_0000000043 information generated by other ICE signals applications running simultaneously on the ICE system. If the pump is in a state where user input is required, the ICE system shall issue periodic Device alerts, alerts/indications every t 7.2.4 CR_0000000044 pump alerts minutes until the required input is provided, as determined by the safety and clinical performance needs for the user input. The ICE system shall display the hard and soft Medication limits of the medication 7.2.5 CR_0000000045 limits being delivered and a warning of overdose limits. The ICE system shall be Infusion capable of displaying 7.2.6 CR_0000000046 summary infusion summary and delivery profile
cell counts. capability to display complete blood cell counts. 6.4.24 CR_0000000239 Monitoring: activated Partial Thromboplastin Time (aPPT) The patient monitoring system shall have the capability to display activated Partial Thromboplastin Time (aPPT) 6.4.25 CR_0000000249 Infusion Management App The Operator shall have the capability to access patient medical information and medical history through the Infusion Management App. # Rqmt ID Name Description Rationale 7.2.1 CR_0000000041 Pump status The ICE System shall display the pump status at all times. 7.2.2 CR_0000000042 The pump shall conform to standards. The pump shall conform to {specify} standards. To ensure that the pump is compatible with the ICE system. 7.2.3 CR_0000000043 PCA information signals PCA app implementations shall be able to receive information signals, such as alarm signals, generated by other ICE applications running simultaneously on the ICE system. 7.2.4 CR_0000000044 Device alerts, pump alerts If the pump is in a state where user input is required, the ICE system shall issue periodic alerts/indications every t minutes until the required input is provided, as determined by the safety and clinical performance needs for the user input. 7.2.5 CR_0000000045 Medication limits The ICE system shall display the hard and soft limits of the medication being delivered and a warning of overdose limits. 7.2.6 CR_0000000046 Infusion summary The ICE system shall be capable of displaying infusion summary and delivery profile
ICE-PCA-MSIS-Mock-Vendor-Submission-v0.11.docx