Knick Protos CONDI 3400(X)-051, Руководство пользователя

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Intended Use
The module is an input module for conductivity measurement with commer-
cially available electrodeless (toroidal) sensors.
The CONDI 3400X-051 module is intended for operation in locations subject to
explosion hazards which require equipment of Group II, device category 2(1),
gas/dust.
In their directive “Title 21 Code of Federal Regulations, 21 CFR Part 11,
Electronic Records; Electronic Signatures“ the US American health agency FDA
(Food and Drug Administration) regulates the production and processing of
electronic documents for pharmaceutical development and production. This
results in requirements for measuring devices used for corresponding applica-
tions. The following features ensure that the Protos 3400(X) modular process
analysis system meets the demands of FDA 21 CFR Part 11:
Electronic Signature
Access to the device functions is regulated and limited by individually adjust-
able codes (“Passcodes“). This prevents unauthorized modification of device
settings or manipulation of the measurement results. Appropriate use of these
passcodes makes them suitable as electronic signature.
Audit Trail Log
Every change of device settings can be automatically recorded and docu-
mented in the Audit Trail Log on the SmartMedia card. The recording can be
encrypted.
Conformity with FDA 21 CFR Part 11