Kaye ValProbe RT, Руководство пользователя

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Chapter 11: Qualification Reports
Kaye ValProbe RT User Manual 105
Lethality
The Accumulated Lethality graph displays lethality totals for each included sensors at
each timestamp programmed or defined to calculate lethality. Alternatively, the lethality
accumulation can be displayed as a bar graph.
Sat P
The Saturation Pressure calculation is only available if the study includes at least one
temperature sensor and pressure sensors.
The Saturation Pressure vs. Measured Pressure graph displays measured pressure from
the selected pressure sensor and the saturation pressure calculated from the temperature
sensors selected in the Edit Sensors screen. To access the Saturation Pressure vs.
Measured Pressure graph, select Temp and Pressure Sensors group from
Select Group
drop-down list.
Sat T
The Saturation Temperature calculation is only available if the study includes at least one
pressure sensor along with temperature sensors.
The Saturation Temperature vs. Measured Temperature graph displays the saturation
temperature calculated from the selected pressure sensor and the measured temperature
from the sensors selected in the Edit Sensors screen. Red horizontal lines on the graph
display the base temperature (Tb) entered during the study setup, and the base
tempe3 K. The text at the bottom of the graph displays if the data passed or failed
three conditions:
•
All measured temperatures and the calculated saturation temperature are
within the specified sterilization temperature band.
•
Each measured temperature and the calculated saturation temperature do
not fluctuate more than 1 K.
•
All measured temperatures and the calculated saturation temperature do not
differ from each other by more than 2 K.
Equilibrium
The Equilibration Time graph displays whether all temperature sensors in the Edit
Sensors list reached the lethality base temperature within a 15 or 30 second time period,
satisfying the equilibration conditions.
Regulations require that sterilization chambers less than 800 liters have an equilibration
time no greater than 15 seconds; sterilization chambers greater than 800 liters should
have an equilibration time of no more than 30 seconds.
This graph is only available if the sensors had a one second sampling rate, and at least
one sensor reached the lethality base temperature. If you did not define the lethality base
temperature during the study setup, the default temperature of 121.1°C is used.