Revision History

Corrected typos after internal review. Added sections for license management.

interdependency rules (cycle consistency check); removed Sterilant Inject phases and associated parameters; redefined “Cycle Complete”; removed paddle switch and general failure functionality; removed Chamber Configuration Parameters report; removed alarms 30, 39, 42, 43, 46, 47, 50, 51, 104, 207, 126, 156, 165, 166, 167, 168, 196, 197, 198, 199, 123, 124, 126, 156, 162, 163, 164, 165, 166, 167, 168, 196, 198, 199; removed Legacy Cycle Converter license; revised chamber capability check (verified at time of cycle consistency);

User privileges for manual device control in dormant sequence; cycle in progress; phase start and complete interlock indicators; gas valve boil-off definition; auto-recovery and PLC event configuration: process run summary report

Incorporated version D of the AccuSOLO SFS.

From Addendum #4: Added in-spec timer when the pressure is less than minimum hold condition for EO Dwell phases; Added definition on when the in-spec timer is held.  Add a new parameter that will be used as maximum alarm pressure tolerance during EO dwell.

Stop heat if jacket > dormant jacket temp SP + 5°C; typo and formatting corrections;

Removed references to “contaminated”; updated info in Event Configuration section; DataTrace import utility; calibration module updates; additional info in database section; Linked Loads; Parameter 84 in EO Dwell phases; alarm 400 for Stop mode; alarm 399 for Hold mode.

Added additional information to Device Diagnostics and Manual Control; added select/deselect all info to charts; added CJC open circuit alarm info; tighten door locks pressure parameter; non-EO abort sequence; start command and Keyword 28; import/export of Event Configuration.

Additional details added to Charts, stopping sequence for Vacuum pump operation, Linked Loads cycle consistency rule, reviewing archived historical data; alarm 372 in EO Inject phases; added note for end of phase dwell durations; removed Subsystem Interlocks; Updated boil-off description; Updated Vacuum phase start interlock, DI-395 must be OFF.

Added description of device interlock alarms; added Alternate Heating/Cooling Control description; updated In-Spec Timer rules; updated Vacuum and Continuous Steam Conditioning phases; updated Cycle Definition section; updated Phase Start Interlocks; updated Abort Command functionality; Added Dynamic Conditioning with Nitrogen and Dynamic Conditioning with Air phases; miscellaneous improvements, typo corrections, additional screenshots, and revised text for clarity.

Updated minimum system components requirements and Typical Server Architecture section. Added System Configuration parameter names to Drum Database Management for clarification. Added additional details to Ramp-Hold Time Parameters. Added In-Spec time and Total Phase Time clarifications for Phase Duration in Device Measurements Summaries. Added RH, AH, and EO Concentration device references to Periodically Reported Device Measurements sections. Additional detail provided for Start-up phase completion when blower feedback set to 0. Updated cycle consistency rules (Value Validation) and added Parameter ID references. Added Start-up Checklist. Added Equipment Quarantine State section. Added Loads with Validation Specification section. Updated Alternate Chamber Heating/Cooling Control section. Additional detail provided on calibration without Calibration Module. Added Process Record with Chart to Reports Added User Audit Log Service and Flexible Audit Trail. Miscellaneous typo corrections and clarifications.

Added Event 498 to prevent cycle start if blower feedback configuration is incorrect Added new Super-Atmospheric EO Dwell phase. Added parameter 30 for EO percentage in EO and inert gas mixture Created new Roles for system functions “Force Clear Alarm” and Abort Cycle. Added Expiry Date to EO Drum Management. Prevent changing certain Load details after Load has been started. Added Super Atmospheric EO Dwell to In-Spec Timer Rules Changes to how summary and deviations are reported for Steam Inject and Conditioning Dwell. Added Monitoring Specification type. Allow Controlling and Monitoring Equipment in the same site. Updated minimum server requirements for App and SQL servers

Formatting and clarity edits. Updated the list of phases that support pressure warnings.