MIRI
®
II-12 Multiroom IVF incubators User Manual Rev. 4.0
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The average N
2
gas variation must stay within SP ± 0.2% absolute on all external sampling
and internal sensor readings.
The gas flow under regular operation is less than 12 liters per hour, and thus, the average
should be below 12 liters.
33.1.5 Cosmetic
•
No misalignment in the lids.
•
Each lid should be opened and closed easily.
•
The seals for the lids must be appropriately attached and aligned.
•
There will not be any scratches or missing paint on the cabinet.
•
Overall, the device must be presentable as a high-quality item.
•
The heat optimization plates are checked for misalignment and shape. These are
placed into the compartments to check for any mismatch due to the compartment
and aluminum blocks' sizes.
34 Validation on-site
Even though at Esco Medical, we strive to do the most comprehensive tests before the device
is shipped to the customer, there is no way to be sure that everything is still OK at the location
when the device is set up.
Therefore, in keeping with established good medical device practice, we have set up a
validation test regimen that must be completed before the device can be accepted into
clinical use.
In the following, we describe these tests and the equipment necessary to perform them.
A test documentation form is also provided. A copy must be provided to Esco Medical for
internal device tracking and device history record.
34.1 Mandatory equipment
All equipment must be of high quality and calibrated.
•
A thermometer with a suitable sensor for measuring in a droplet of media covered
with Paraffin oil with a resolution minimum of 0.1 °C
•
A thermometer with a suitable sensor for measuring on an aluminum surface with a
resolution minimum of 0.1 °C
•
A CO
2
analyzer with a range of 0.0 – 10.0%.
•
An O
2
analyzer with a range of 0.0 – 20.0%.
•
A Pressure tester with a range of 0.0 – 1.0 bar.