Chapter 6 - Functional Testing; Automatic Functional Testing; Manual Functional Testing; Batch-Related Tests - Sirona DAC PROFESSIONAL Instrucciones De Uso

Chapter 6 – Functional testing

Automatic functional testing

The electronic parameter control continuously and automatically monitors the interaction between those
parameters relevant for the sterilization, namely pressure, temperature, and time. The process evaluation
system of the autoclave compares the process parameters during the program with each other and
monitors these in terms of their thresholds. The autoclave monitoring system tests the device components
in terms of the functionality and their plausible interaction. If the thresholds defined for the parameters are
exceeded, the autoclave issues a warning or an error message. If necessary, it interrupts the program with
an appropriate message. If the program was successfully completed, an appropriate message is shown on
the display.

Manual functional testing

You can track the progress of the program on the display using the values shown. In addition, you can
determine whether a program was successful using the log recorded for every program (see Chapter 5 –
Logging).

Batch-related tests

Test set for Helix test
The Helix test set is an indicator and batch monitoring system that satisfies the DIN EN 867-5 standard. It
comprises a process challenge device, the Helix, and an indicator strip.
If you are sterilizing Critical B category instruments, the Helix test set should be included in every
sterilization cycle for cycle monitoring.
You can conduct a steam penetration test with the Bowie & Dick test in the Universal Program at any time
independent of the Helix test.
If the Helix process challenge system is used properly, staining of the plastic surface may occur. This
staining does not have any effect on the functionality of the Helix process challenge system.

Vacuum test

The test is used to detect any leaks from the autoclave. The leak rate is determined in the test.
Carry out a vacuum test in the following situations:
 Once a week during routine operation
 At the initial start-up
 After longer periods of disuse
 In case of a relevant error (e.g., in the vacuum system)
Carry out the vacuum test with a cold and dry autoclave as follows:
Switch the device on at the power switch. The display shows its initial operating state.
1.
Hold down the (P) key until the message Vacuum test appears on the display.
2.
Close the door.
3.
Press the (S) key to start the vacuum test.
4.
The evacuation pressures and the equilibration time or measurement period are shown on the display.
After the measurement period has elapsed, the chamber is ventilated (corresponding message on the
display). A message showing the leak rate is then shown on the → display. If the leak rate is too high, that
is, it is greater than 1.3 mbar, a corresponding message is shown on the display. The display also shows
the current batch number for the day alternating with the message Acknowledge with "+" key. After
pressing the (+) key, you can open the door.
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