User's Manual

Chapter 9: Qualification Study
Kaye ValProbe RT User Manual 84
Qualification Study
9.1. Introduction
Once the setup is defined and loaded into the Kaye ValProbe RT and the sensors, if
necessary, have gone through a Verification, everything is ready to run a qualification study.
The Kaye ValProbe RT uses the qualification parameters defined in the setup to perform the
qualification study. Depending on the start and stop qualification conditions defined the study
performs a fully automatic qualification, a fully manual qualification, or a mixture of automatic
and manual.
During the qualification study, the Kaye ValProbe RT performs calculations and compiles data
for the qualification reports. Qualification data is always written to the Logger’s internal
memory, as well as transmitted to the Base Station for storage in the Base Station memory.
The ValProbe RT Loggers utilizes internal memory to maintain qualification data during a
study. During the study, data from the Loggers is transmitted via the transit rate to the Base
Station for storage. When Qualification is complete, the Base Station searches for any missing
samples and connects to the affected Loggers to collects missing samples. The User can then
save the file and the study data is transferred to the Console. Qualification data resides in the
internal memory of the Base Station until it is transferred to the console.
The Base Station is also equipped with a Lithium battery to provide short-term power, 60
minutes, in case of AC power loss during the run. The intent of the battery is to provide
enough time (approximately 60 minutes) to perform an orderly shutdown of the system. When
the Kaye ValProbe RT detects that the AC power has failed and the system is running from
battery, it displays an indication on the front panel LED.
Note: In the event of power glitches or short-term drops in supply voltage (“brownouts”), there
is a remote chance that the Kaye ValProbe RT will fail to fall back to its backup battery.
In this case, the Validator could reset and potentially lose any study data stored in
internal memory. To prevent this from occurring, Kaye recommends connecting the
ValProbe RT to an Uninterruptible Power Supply (UPS) in areas likely to experience
brownouts.
When the qualification study is complete, reports can be generated to document the specifics
of the study using the Kaye ValProbe RT report generator (see Chapter 11). Before beginning
the qualification study:
• Place the Kaye ValProbe RT in a location with stable and even temperature, not exposed to any
local heat sources (i.e., close directly to a sterilizer, an open door causing a draft, etc.).
Temperature variations and/or exposure to external heat sources during qualification studies
may cause temporary temperature measurement errors.
• The Kaye ValProbe RT clears the internal memory from temporary files on startup. To ensure
maximum memory availability it is recommended to power-cycle the Kaye ValProbe RT from
time to time, especially before running long studies.
• To provide maximum accuracy during the qualification study, power up the ValProbe RT and let
it run for approximately 30 minutes in the operating environment where qualification is to be
performed for the ValProbe RT to acclimate to the ambient temperature.
• Position the sensors in the vessel or chamber (the asset) being tested.