MIRI
®
II-12 Multiroom IVF incubators User Manual Rev. 4.0
70
Ensure that the sample lines do not contain any particles.
36 Clinical use
Congratulations! Your device is now ready for clinical use with the validation tests completed
and the test report submitted to Esco Medical.
It should provide many years of stable service.
It is necessary to monitor the performance of the device continually.
Use the below scheme for in-use validation.
Do not attempt to run the MIRI
®
II-12 multiroom IVF incubator for clinical
purposes without access to high-grade quality control validation equipment.
Table 36.1
Validation intervals
Task
Every day
Every week
Temperature check
X
CO
2
gas concentration check
X
O
2
gas concentration check
X
Check log for anomalies
X
CO
2
gas pressure check
X
N
2
gas pressure check
X
pH check
X
36.1 Temperature check
The temperature check is performed using a high-precision thermometer. Place the
thermometer on each zone and verify the temperature. Calibrate if necessary.
Please refer to the "13.5.3 Temperature calibration menu" section for more information on
how to perform the temperature calibration.
PASS:
•
All temperatures measured on the bottom of the compartment in the locations
where the dishes would be placed must not deviate more than ± 0.2
°C from the
setpoint.
•
All temperatures measured on the lid must not deviate more than ± 0.5
°C from
the setpoint.
36.2 CO
2
gas concentration check
The CO
2
gas concentration is checked for deviations. The gas sample port on the side of the