IN-E-HyClip DI-V1_10
Rotronic AG
Bassersdorf, Switzerland
Document code
Unit
Instruction Manual
Document Type
HygroClip DI digital interface: instruction
manual
Document title
Page
14
of 24
© 2007; Rotronic AG
IN-E-HyClip DI-V1_10.doc
IMPORTANT:
All devices within an RS-485 multi-drop should use the same baud rate. Communication within
the RS-485 multi-drop will not work when the devices are configured with different baud rates.
HygroClip DI-4 and DI-4-WL: after changing the baud rate in Device Manager, you should also
reflect the change in the configuration of the internal Digi International module used by the device
to connect to the LAN. See Baud rate compatibility requirements.
7.3 Compliance with FDA 21CFR Part II and GAMP
When used together with the validated ROTRONIC HW4 software – Professional Edition; the
HygroClip DI complies with the FDA / GAMP requirements regarding electronic records and
electronic signatures. HW4 is designed to keep track of configuration changes and of any probe
adjustment. HW4 also keeps track of user events (main operations performed by each user) and
self-events (software problems). The records generated by HW4 are protected, have an
electronic signature and can be cross referenced one with the other.
7.4 Device
protection
This function is used to protect the HygroClip DI against malicious users. This is particularly
useful when the device is exposed to the Internet. When a device is protected, the following
functions are disabled:
•
All Device Manager functions
•
Log function programming (HygroLog NT)
•
Probe
adjustment
•
Deletion of files from the device memory card (HygroLog NT)
Warning:
The following HW4 automatic functions are also disabled for the protected device:
•
Automatic address change when adding new devices to a RS-485 multi-drop network
•
Automatic synchronization with the HW4 PC clock
The procedure used to protect or unprotect a device is described, using the HygroClip DI as an
example:
Select the device in the device tree and open Device Manager > Device Information: