Hazard Statements

Please review the following Smart Device Connectivity hazard statements.

CAUTION: Ensure with hospital administration that the Smart Device Connectivity system and all integrated components have been certified by Hillrom prior to room occupation by patients.

CAUTION: The system must be recertified and validated after configuration changes.

CAUTION: It is important to associate any wirelessly connected beds used for patient care to a valid facility location at the bedside to ensure that data from the bed is provided to the electronic medical record (EMR) and supported clinical interfaces.

CAUTION: If a wirelessly connected bed has been associated with an incorrect location, use the bedside interface to associate it with a valid location. If another wirelessly connected bed has been incorrectly assigned to that location, the incorrect location can be overridden via the bedside interface.

CAUTION: The system will remove a wirelessly connected bed from an assigned location if the bed is connected via a wired connection and the assigned wired and wireless locations are different, to defer to the greater reliability of the wired connection being accurate.

CAUTION: If any Smart Device Connectivity connected devices lose connections to the Gateway, follow your hospital's manual processes to complete all patient and caregiver workflows. For example:

In the event of a system failure to transmit vitals monitor, bed, and/or risk score data to the EMR, this data should be manually charted in the EMR.
In the event of a system failure to process or transmit ADT messages or notifications, patient admissions/discharges/ transfers should be viewed within the ADT system, via alternative interfaces, or obtained from the charge nurse.
In the event of a system failure to process or transmit EMR-based notifications, a patient's condition should be assessed based on vital signs and EMR data.
In the event of loss of power, a backup generator should be used to maintain connected device operations and network connectivity.
Incorrect association of patient data is mitigated by the segregation of customer data into distinct databases using a unique identifier for each customer. This risk is also addressed via UX design, usability testing, and other risk control measures on supported vital signs monitors. If incorrect association of patient data were to occur, only patient data from the vital signs monitor would be impacted; notifications based on orders, lab values, medications, and other EMR data not from the vital signs monitor would not be impacted. Erroneous data could be detected by comparing displayed data on the vitals monitor to data in the ADT and EMR systems.
The Connex® Spot Monitor and Connex® Vital Signs Monitor will indicate loss of network connectivity and indicate failed patient queries, along with suggested troubleshooting actions.
System deployment will be certified prior to clinical use and after any configuration changes.
System software updates are validated by Hillrom at the system level prior to clinical deployment. Software updates should not disrupt clinical operation of the system, as single clustered servers can be taken offline for software updates without affecting online servers.
In the event of a system failure, the system can be rolled back to a prior software release to maintain operations while troubleshooting occurs.

CAUTION: Smart Device Connectivity relies on complete and accurate data being entered into all integrated systems and devices. It is very important that complete and accurate patient, facility, and location information is entered at the device level for all component systems to ensure the correct data is associated with the correct patients, facilities, and locations.

CAUTION: Hospital network connectivity is necessary for bed data and patient vitals and risk score data to be transmitted to the hospital EMR system and supported clinical interfaces and for hospital ADT- and EMR-based notifications to be sent to caregiver Voalte mobile devices. An indication of loss of network connectivity on Hillrom vitals monitors and caregivers' Voalte mobile devices mitigates the risk of a hospital network outage and is consistent with industry standards. Standard hospital procedures should be followed to prevent possible delays in treatment. A patient must be manually checked and vitals signs monitor data confirmed by a caregiver at the patient's bedside before treatment decisions are made.

CAUTION: In the event the Dashboard loses connection with the Smart Device Connectivity system, it will display a visual indication of connectivity loss so it is clear that the displayed data may not be the latest available.

CAUTION: In the event of an error in the process of the client browser rendering the Smart Device Connectivity Dashboard, the Dashboard will display an error indication so it is clear that the Dashboard is non-functional.

CAUTION: The Dashboard can be configured to remove stale/outdated patient-related data after a configured amount of time has elapsed. It is important to define appropriate “remove after” times if facility policy dictates that caregivers should not act on stale/outdated data. Otherwise, the most recent data will be displayed until patient discharge or transfer.

CAUTION: The Smart Device Connectivity Dashboard requires the CFCM non-vitals alert column to be displayed when the "Bed HR/RR On" column is selected to ensure users are aware that if a CFCM non-vitals alert is generated the CFCM patient monitoring activities may not occur even though the "Bed HR/RR On" column displays with a green check mark (On).

CAUTION: All instances of the Dashboard will restart in staggered fashion upon a saved edit of a dynamic data column (such as those displaying patient physiologic data) or communication disruption in order to distribute the processing required to load each instance. Each connected Dashboard instance will be randomly assigned a recovery wait time between 2 and 7 minutes, with the remaining wait time displayed counting down in seconds to zero.

CAUTION: Data changes or notifications indicating high risk to a patient must be manually checked and confirmed by a caregiver at the patient's bedside before treatment decisions are made.

CAUTION: When the Smart Device Connectivity system is not operational—either due to system maintenance, servicing, or an unanticipated failure—staff must follow standard hospital notifications and patient care procedures. The system must be recertified and validated after configuration changes. For more information, contact Hillrom Technical Services at (800) 445-3720.

CAUTION: All caregivers should be trained on a hospital's proper notification workflow and be aware of possible consequences to the patient if notification procedures are not followed.

CAUTION: The hospital should perform periodic testing of the Smart Device Connectivity system to ensure the system is working properly, including after any Smart Device Connectivity system upgrades or component device upgrades, connections, disconnections, or resets. The system must be recertified and validated after configuration changes. For more information, contact Hillrom Technical Services at (800) 445-3720.

CAUTION: Hillrom recommends that multiple levels of escalation should be in place for Voalte notification calls.

CAUTION: Clinical decision support systems such as Smart Device Connectivity are not meant to take the place of provider or caregiver interactions and knowledge or judgement. This system is meant to augment their clinical knowledge and assist in more timely and patient-specific care. Caregivers should not view this system as a replacement for their current clinical practice.