MIRI
®
TL family`s multiroom IVF incubators User Manual Rev. 1.0
89
33 The Validation guide
33.1 Product release criteria
The Esco Medical MIRI
®
TL6 and MIRI
®
TL12 multiroom IVF incubators undergo strict
quality and performance testing before being released for sale.
33.1.1 Performance
Each component used in the MIRI
®
TL6 and MIRI
®
TL12 multiroom IVF incubator is
tested during the manufacturing process to ensure a defect-free unit.
Before release, the incubator is tested per a release test having a duration of at least 24
hours, using high-performance thermometers and gas analyzers, along with real-time
data logging to ensure that the unit lives up to expected performance standards.
Pass I:
Internal sensor temperature variation from setpoint 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.
33.1.2 Electrical safety
An electric safety test is also carried out using a high-performance medical safety tester
with each unit to ensure that electric requirements for medical devices defined by the
EN60601-1 3
rd
edition standards are met.
33.1.3 Communication & data logging
Each unit is connected to a computer running the MIRI
®
TL6 or MIRI
®
TL12 data logging
software. Gas is supplied to the unit, and the system is activated. The data received by the
PC program is analyzed to ensure communication between the incubator and the PC.
33.1.4 Gas concentration levels and consumption
A leak test is performed on each compartment. The maximum leakage allowed through
the seals is 0.0 l/h.
The average CO
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 2 liters per hour, and thus, the average
should be below 2 liters for both MIRI
®
TL6 and MIRI
®
TL12 multiroom IVF incubators.
