Intended Use; Summary And Explanation Of The Test System - Guardian R1000 Operation Manual

I – Introduction
This Guardian Reader Manual contains operating instructions
for the Guardian Reader as well as information regarding the use of
Alexeter's Bio-Detect Test™, and other Alexeter-approved test strips
containing a Radio Frequency Identification (RFID) tag. For the
remainder of this manual, these will simply be referred to as "Test
Strips". Be sure to check Alexeter's website (www.alexeter.com) for
the latest version of this manual as well as the recent Technical Bulle-
tins. Sign up to automatically receive Technical Bulletins and Updates
via email; contact Alexeter for details.

Intended Use

The Guardian Reader™ is a portable biological agent detec-
tionand identification screening device. It is intended only for use by
trained personnel and only for use in the field to perform rapid analysis
on environmental samples that may contain biological threats. It is
NOT intended for confirmatory analysis, diagnostic or clinical use. It
is NOT intended for use by consumers or individuals who have not
received factory-approved training.
IMPORTANT: The Guardian Reader is an integral component of
the Guardian Reader System and is NOT intended to be a replace-
ment for a trained user's experience and sound judgment in the field.
Although the Guardian Reader has been shown to provide a reliable
and accurate representation of results in laboratory and field trials,
the user is expected to ensure that all proper procedures, cautions and
warnings are exercised when operating this equipment. Alexeter rec-
ommends that factory-approved personnel have trained all eventual
users of this equipment. Only factory-approved trained personnel
should use the Test Strips or the Guardian Reader.
Summary and Explanation of the Test
System
The Guardian Reader System™ employs unique biological
reagents (antibodies) for the detection and identification of biologi-
cal agents, in conjunction with an analytical measuring instrument,
Chapter
1