MIRI
®
TL family`s multiroom IVF incubators User Manual Rev. 1.0
97
Place the thermometer on each zone and verify the temperature.
Pass: all temperatures measured on the compartments' lid must not deviate more
than ± 0.2 °C from the setpoint.
If calibration is needed, please refer to the "13.5.1.1 Temperature calibration" section for
more information on how to perform the temperature calibration.
An iterative process may be needed if differences in the temperature levels are
found and compensated through the calibration procedures. Bottom and lid
temperatures will affect each other to some extent. There will be no crossover heat
noticeable between compartments.
35.10 6-hour stability test
Following the careful validation of the single parameter, a 6-hour (minimum duration)
check must be initiated.
The device must be set up as closely as to the condition under which it will be running in
clinical use.
If the preference of CO
2
setpoint is 6.0% or temperature is different from the default
setting, an adjustment needs to be done before the test.
If the device will not be clinically operational with the O
2
regulation activated, but there
is N
2
gas available, the test should be conducted with O
2
regulation switched on and with
N
2
gas supply.
If the N
2
is not available, the test can be done without it.
Make sure that the Esco Medical data logger software is running.
Check that parameters are logged and give a meaningful reading. Let the device run
without interfering for at least 6 hours. Analyse the results on the graphs.
Pass I:
Internal sensor temperature variation from set point is within ± 0.1 °C absolute.
Pass II
Internal sensor CO
2
concentration variation from setpoint within ± 0.2% absolute.
Pass III:
Internal sensor N
2
concentration variation from setpoint within ± 0.2% absolute.
Pass IV:
Gas flow CO
2
less than 2 l/h.
Pass V:
Gas flow N
2
less than 5 l/h.