same patient, ID/MRN, Bed Location, Patient Last Name, DoB, preventing or etc.) is the same from providing a chance for ALL connected devices. alerting on mismatch If there is a mismatch, the and adding/correcting ICE system shall provide the mismatched data. a mechanism to correct. ICE Applications shall have access to patient To prevent incorrect data and device status patient data from being data collected during recorded, especially patients who are moving transport, for instance by an infusion pump, patient from Location A to Data Collection monitor, or telemetry Location B and with pack that is moving with multiple devices 6.2.4 CR_0000000005 During connected, all of which the patient. Access may Transport be via a wireless network may not be going with where available and patient to Location B. applicable or by a download of cached data To prevent the loss of data when the patient and including records of events devices arrive at their that occur during transport. destination. We want the ICE system to be able to communicate to Battery-powered devices users when attached devices have low battery must indicate to the ICE system how they are levels. The individual powered (mains vs devices may not be aware Alarms - battery), when they of the context of use to the 6.2.6 CR_0000000007 battery switch from mains to extent that an application battery, and when on is, so the application can battery provide some send alerts like 'the battery won't last until the end of indication of remaining battery life. the surgery'. The PCA application Users should be kept aware shall display a of the system status as Alarm, user 6.2.12 CR_0000000013 notification when it loses components are added or notification connectivity to any removed - intentionally or relevant component. otherwise. How devices handle unexpected disconnection Medical devices or other will vary according to the equipment intended for type of device, use case, use with an ICE system ICE downtime, and environment. This may must be capable of require controlled devices 6.2.13 CR_0000000014 data handling unexpected to a failover or availability disconnection from the 'safe' state, monitoring ICE system at any phase devices maintaining a local of operation. cache of data to be sent upon reconnection, and so on.
ID/MRN, Bed Location, Patient Last Name, DoB, etc.) is the same from ALL connected devices. If there is a mismatch, the ICE system shall provide a mechanism to correct. same patient, preventing or providing a chance for alerting on mismatch and adding/correcting the mismatched data. 6.2.4 CR_0000000005 Data Collection During Transport ICE Applications shall have access to patient data and device status data collected during transport, for instance by an infusion pump, patient monitor, or telemetry pack that is moving with the patient. Access may be via a wireless network where available and applicable or by a download of cached data when the patient and devices arrive at their destination. To prevent incorrect patient data from being recorded, especially patients who are moving from Location A to Location B and with multiple devices connected, all of which may not be going with patient to Location B. To prevent the loss of data including records of events that occur during transport. 6.2.6 CR_0000000007 Alarms - battery Battery-powered devices must indicate to the ICE system how they are powered (mains vs battery), when they switch from mains to battery, and when on battery provide some indication of remaining battery life. We want the ICE system to be able to communicate to users when attached devices have low battery levels. The individual devices may not be aware of the context of use to the extent that an application is, so the application can send alerts like 'the battery won't last until the end of the surgery'. 6.2.12 CR_0000000013 Alarm, user notification The PCA application shall display a notification when it loses connectivity to any relevant component. Users should be kept aware of the system status as components are added or removed - intentionally or otherwise. 6.2.13 CR_0000000014 ICE downtime, data availability Medical devices or other equipment intended for use with an ICE system must be capable of handling unexpected disconnection from the ICE system at any phase of operation. How devices handle unexpected disconnection will vary according to the type of device, use case, and environment. This may require controlled devices to a failover or 'safe' state, monitoring devices maintaining a local cache of data to be sent upon reconnection, and so on.