Mini MIRI
®
Dry and Mini MIRI
®
Humidity Multiroom IVF incubators User Manual
Rev. 3.0
62
The gas flow under regular operation in the Mini MIRI
®
Dry multiroom IVF incubator is
less than 2 liters per hour, whereas in the Mini MIRI
®
Humidity multiroom IVF incubator
–
4 liters per hour. The average should be below 2 liters in the Mini MIRI
®
Dry multiroom
IVF incubator, whereas in the Mini MIRI
®
Humidity multiroom IVF incubator
–
below 4
liters.
The average N
2
gas variation must stay within setpoint ± 0.2% absolute on all external
and internal sensor readings.
The gas flow under regular operation in the Mini MIRI
®
Dry multiroom IVF incubator is
less than 2 liters per hour, whereas in the Mini MIRI
®
Humidity multiroom IVF incubator
–
8 liters per hour. The average should be below 2 liters in the Mini MIRI
®
Dry multiroom
IVF incubator, whereas in the Mini MIRI
®
Humidity multiroom IVF incubator
–
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.
•
No 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.