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Conformity with FDA 21 CFR Part 11
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 docu-
ments for pharmaceutical development and production. This
results in requirements for measuring devices used for corre-
sponding applications. The following features ensure that the
measuring devices of the Transmitter Cond Ind 7100e/2(X)H
Series meet the demands of FDA 21 CFR Part 11:
Electronic Signature
Access to the device functions is regulated and limited by indi-
vidually adjustable codes – “Passcodes” (for Passcode Editor
see Page 56, overview of factory settings on back of manual).
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
Every (manual) change of device settings can be automatically
documented. For that purpose, each change is marked by a
“Configuration Change Flag”, which can be interrogated and
documented via HART communication. Then the changed
device settings/parameters can also be retrieved and docu-
mented via HART communication.
70098_E_CI7100_2XH.QXD 27.07.2005 9:27 Uhr Seite 9
- Instruction manual 1
- Contents 3
- Safety information 5
- EC Declaration of Conformity 8
- Overview of Transmitter 15
- Assembly 16
- Mounting plan 17
- Fig.: Mounting plan 17
- Fig.: Pipe-mount kit 18
- Pipe mounting, panel mounting 18
- Fig.: Panel-mount kit 19
- Installation and connection 20
- Division 2 wiring 20
- Terminal assignments 21
- Wiring examples 24
- InPro 7250 HT sensor 25
- Cond Ind 7100e/2(X)H 25
- User interface and display 26
- Operation: Keypad 28
- Safety functions 29
- Passcodes (factory setting) 33
- Configuration 34
- Menu group 35
- Selection / Default 36
- Individual settings 37
- After correct input a 39
- Code Display 41
- Concentration measurement 43
- 0 ... 120 sec 49
- Time constant 0 to 120 sec 49
- Conductivity 49
- arrow key 53
- Proceed with enter 53
- (xxxx s) 55
- Display Action 56
- Calibration 58
- Display 60
- Display Action 61
- Product calibration 64
- Zero calibration in air 66
- Measurement 70
- Temperature probe adjustment 70
- Diagnostics functions 71
- Operating states 73
- Error messages (Error Codes) 74
- Display of last error message 75
- Sensoface 76
- Problem 77
- Appendix 79
- Specifications 80
- Calibration solutions 86
- Sodium chloride solutions 87
- Concentration curves 89
- -05- Nitric acid HNO 93
- FM Control Drawing 94
- Explosion protection 96
- CSA Control Drawing 98
- TA-194.301-MTE02 011005 108
- Software version: 1.1 108
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