ThermoFisher Scientific HERASAFE 2025, Operating Instructions Manual

Page: 37 / 76

HERAsafe 2025 50161258 | 37
Start-up |
Chapter 5
Installation Test
Do not operate the device before the installation test has been completed.

The installation inspection of the device must be conducted in accordance with EN
12469. The cabinet may be operated as a Class II microbiological safety cabinet, in
accordance with EN 12469 / 2000, if the device functions or function patterns listed
below were checked and if the test results are within the safety value tolerances
specified by the manufacturer:

Electrical safety test

Inflow speed test

Downflow speed test

Leakage test of HEPA filters

Airflow control test

A repeat test must also be performed after repairs to the device or after considerable
changes (more than 5 cm) to the location of the device.

The operator must prepare a test report or request a written test report from the
authorized test service.
NOTE Safety warranty
The operational safety of the device, particularly the personal and material
protection, are guaranteed only if all safety functions of the device have been
tested and approved.
Thermo Electron LED will not warrant the operational safety if the device is
operated without performance of the required installation test or if the
installation test and repeat test are not performed by adequately trained and
authorized personnel!
NOTE Device hygiene
The initial start-up with subsequent installation test does not include any
decontamination measures. For operation in the work process, the sample
chamber of the device and the accessories required for the work process must
be disinfected and cleaned in accordance with the hygiene guidelines set forth
for the application.