Digi HygroClip DI digital interface instruction manual Compliance with FDA 21CFR Part II and Gamp

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IN-E-HyClip DI-V1_10

Rotronic AG

Bassersdorf, Switzerland

Document code

Unit

 

 

 

HygroClip DI digital interface: instruction

Instruction Manual

manual

 

Document Type

Document title

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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.

7.3Compliance 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.

7.4Device 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:

© 2007; Rotronic AG

IN-E-HyClip DI-V1_10.doc

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Contents HygroClip DI digital interface instruction Manual HygroClip DI Digital InterfaceIN-E-HyClip DI-V110 Contents HygroClip DI-3 OverviewModels HygroClip DI-4 Power supplyProbes HygroClip DI-4-WLIN-E-HyClip DI-V110 Connector identification Pin-out diagrams Operation with the HW4 softwareHW4 Device Manager Device Manager Menu Bar FileDevice Information Language / Unit System Probe Inputs Digital Interface Compliance with FDA 21CFR Part II and Gamp IN-E-HyClip DI-V110 IN-E-HyClip DI-V110 Baud rate compatibility requirements Ethernet local area network RS-485 multi-drop networkExample HygroClip DI with USB port USBSpecifications Accessories Communications protocolElectrical Installation Guidelines Power supply wiringLightning protection Document releases Hardware and firmware

HygroClip DI digital interface specifications

The Digi HygroClip DI is an advanced digital interface designed for precise measurement and control of humidity and temperature in various applications. An integral tool for numerous industries, the HygroClip DI is particularly prized in environmental monitoring, HVAC systems, agriculture, and laboratories, where accurate climate data is essential for operational efficiency and sustainability.

One of the standout features of the Digi HygroClip DI is its exceptional measurement accuracy. The device utilizes a high-performance capacitive sensor for humidity measurement and a precision thermistor for temperature. This combination enables the HygroClip DI to deliver consistent and reliable readings, ensuring that users can trust the data used for critical decision-making processes.

The HygroClip DI incorporates innovative digital signal processing technology. This technology enhances the device's stability and response time, significantly improving performance compared to traditional analog sensors. This digital approach also simplifies integration with other systems, making it an ideal choice for applications requiring connectivity to data loggers, control systems, or telemetry networks.

Another significant characteristic of the HygroClip DI is its robust design. Constructed to withstand demanding environments, the device is both water-resistant and resistant to dust, ensuring that it maintains functionality even in challenging conditions. Its design also allows for easy installation, often requiring minimal effort to mount or connect.

Flexibility is another key advantage of the Digi HygroClip DI. It comes with various calibration options and can accommodate different operating ranges, making it versatile for diverse industrial needs. Users can select calibration settings that best match their specific environment, further enhancing the accuracy and efficiency of the device.

Additionally, the HygroClip DI is equipped with intuitive interfaces for easy operation. With user-friendly software options available, users can easily manage settings, monitor conditions, and analyze data trends. This accessibility makes it suitable for both experienced professionals and newcomers to the field.

Overall, the Digi HygroClip DI embodies a perfect blend of technology, accuracy, and user-friendliness. Its features cater to a wide range of measurement needs, making it an invaluable tool for any professional seeking reliable climatic data in their operations. Whether used in industrial settings or research facilities, the HygroClip DI is a testament to innovation in environmental monitoring technology.
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