Multi-zone ART Workstation User Manual Rev. 6.0
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29 The Validation guide
29.1 Product release criteria
The Esco Medical Multi-zone ART Workstation undergoes a strict quality and
performance testing before being released for sale.
29.1.1 Performance
Each component used in the Multi-zone ART Workstation is tested during the
manufacturing process to ensure a defect-free unit.
Before release, the Multi-zone ART Workstation 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.
The below list is only applicable for Multi-zone ART Workstation with a built-in gas mixer
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 8 l/h
29.1.2 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.
29.1.3 Communication & data logging
Each unit has a built-in AIO PC running the Multi-zone ART Workstation
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 Multi-zone ART
Workstation and the PC.
29.1.4 Gas concentration levels and consumption (only for models with a
built-in gas mixer)
A leak test is performed on each compartment. The maximum leakage allowed through
the seals is 0.0 l/h.
