User Manual

Glossary
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 LITE
system is designed to aid compliance with 21 CFR Part 11.
Antenna – The Gateway and associated transmitters are provided with an antenna. The
antenna is designed for both transmit and receive and is configurable for either horizontal or
vertical mounting.
Autodialler – An optional Autodialler can be provided by Comark for connection to the
Gateway to ensure that in the event of an alarm, an audible alarm message is relayed by
analogue phone.
Email Server IP address – If you have an existing email server, then entering its fixed IP
address will enable the Gateway to send emails to anyone using your own email server.
Ethernet/Network/LAN – Terms used to describe the connection of the Gateway to various
users with access to the system. Personal Computers are connected together using a
network, via Ethernet ports combining to make a Local Area Network of many users.
FCC – Federal Communications Commission.
Firmware – Terms used for the software that runs in each transmitter to make it work.
Frequency – The frequency in use by RF500 LITE is 2.405GHz.
IE – Internet Explorer. Users of the system log in to RF500 LITE by using Internet Explorer or
other web browsing software on a LAN.
IP address – A fixed IP address is required for use on a Network. Contact your IT department
for allocation of a number for your system.
Licence free – Term used to describe the frequency the system operates in terms of licence
to broadcast. RF500 LITE 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.