User's Manual
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means of browsing through web-pages gain access to the Gateway for all setup and data
viewing.
21 CFR – The FDA (Food and Drug Administration) in the USA, issued regulations Title 21
CFR (Code of Federal Regulations) Part 11 that provide criteria for acceptance by FDA or an
approved regulatory body, for the acceptance of electronic records, electronic signatures, and
handwritten signatures executed to electronic records as equivalent to paper records and
handwritten signatures executed on paper. These regulations, which apply to all FDA program
areas, are intended to permit the widest possible use of electronic technology, compatible with
the FDA’s responsibility to promote and protect public health. Part 11 applies to any record
governed by an existing FDA predicate rule that is created, modified, maintained, archived,
retrieved, or transmitted using computers and/or saved on durable storage media. In other
words any record from a data logger for instance that is at some stage stored on a PC or where
a PC is used to retrieve the data, 21 CFR Part 11 can be applied. The RF500 system is
designed to aid compliance with 21 CFR Part 11.
Firmware – Terms used for the software that runs in each transmitter to make it work.
Firmware upgrades can be installed using the wireless network.
PST – Precision Semiconductor Technology or Thermistor. A sensor for measuring
temperature.
PT100 – Platinum Resistance Device for measuring temperature.
RH – Relative Humidity. Term used to describe the percentage of water in the atmosphere.
Modem – Device for connecting to an analogue phone line to communicate with another
Personal Computer remotely. Used to dial-in to the Gateway for user access and service.
Licence free – Term used to describe the frequency the system operates in terms of licence to
broadcast. RF500 uses a licence free band of 2.4GHz where the end user is not required to
purchase any kind of licence in order to use the product. Also refer to the FCC approvals.
FCC – Federal Communications Commission
Frequency – The frequency in use by RF500 is 2.4Ghz.
IE – Internet Explorer. Users of the system log in to RF500 by using Internet Explorer or
other web browsing software either on a LAN, Modem or direct to the Gateway.
Antenna – The Gateway and associated transmitters are provided with a Long Range
Antenna. The antenna is designed for both transmit and receive and is configurable for either
horizontal or vertical mounting.
Note: Under no circumstances should the antenna be removed from the Gateway when the
Gateway is switched on as serious damage could result. If the Antenna has been removed then
the Gateway should not be switched ON.
Note: The device has been designed to operate with the antenna supplied by Comark, and
having a maximum gain of 7dB. Antennas not supplied by Comark or having a gain of greater