The new v12.1 software update headed your way brings a range of features designed to enhance your experience working with the Spectra OptiaTM Apheresis System. The software enhancements are designed to fortify cybersecurity measures and improve usability of the system. There are also several alarm upgrades that will further assist you in caring for patients and donors.
Please note: The changes made in software v12.1 do not affect the intended use, performance, patient safety profile, or efficacy of the Spectra Optia system. Terumo Blood and Cell Technologies has verified the Spectra Optia software v12.1 in accordance with our design control requirements. Any validation required by your facility should be conducted according to your change control process.
Below are some of the features you can look forward to with v12.1.
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The Run Summary Report will now include alarms that occur during start-up, kit loading, saline prime, and custom prime.
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When converting an exchange procedure to a single-needle procedure, the pumps will now automatically pause after confirming the single-needle selection. After you confirm the patient is connected, touch
Resume Run to continue the procedure.
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During exchange procedures and after conversion to a single-needle procedure, the system will now check to ensure the return line saline clamp is closed (with or without a custom prime or saline rinse). This will help with consistency across procedures.
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The maximum run time for an exchange procedure is now capped at 360 minutes instead of the previous 480 minutes, to align with the Exchange Set life.
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The “Low level reservoir sensor detected excess fluid” alarm (#2525) has been updated to include both collect line and plasma line occlusions as possible causes.
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The “Packing factor exceeded recommended limits” alarm (#4038) instructions have been updated to include the appropriate packing factor for the procedure.
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For several alarms, the
Disable AIM button has been removed from the initial alarm screens. This is to reduce the chance of an operator disabling the Automated Interface Management (AIM) system in a stressful situation. In addition, some AIM alarms may resolve themselves or be resolved by operator actions.
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A new “Multiple AIM system alarms have occurred” alarm (#1176) has been created that is triggered after four AIM system alarms. It includes the option to disable the AIM system if necessary.
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The system software has been modified to mitigate the occurrence of “Safety system detected software communication error” and subsequent reboot of the system (sometimes referred to as “watchdog reboots”). Additional measures were implemented to mitigate “Inlet line prime failed” alarms.
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If the AIM system is disabled, the trend graph will still be displayed on the collection status screen, but the green diamonds will not be displayed.
You will receive the
customer letter along with a training presentation that contains screenshots of the changes. You will receive a second notification this summer announcing when the upgrade will be available. Every Spectra Optia operator should review this presentation prior to performing a procedure with the v12.1 software. If additional training is needed, please contact your local Terumo Blood and Cell Technologies representative.