Guardian R1000 Manuale utente
DISCLAIMER:
For use by trained personnel
to perform rapid biological
screening on environmental
samples.
Not for conrmatory analysis,
diagnostic or clinical use.
Guardian Reader Model R1000 Software version 1.22 Operating Manual Version 2.82 Rev. 10.1.13
THE RECOGNIZED LEADER IN
COMMERCIAL BIOLOGICAL DEFENSE SYSTEMS
Page 2
Table of Contents
Introduction
Intended Use ..................................................................................................................................5
Summary and Explanation of the Test System ..............................................................................5
Principles of the Immunoassay Test Strip ....................................................................................6
Principles of the Guardian Reader .................................................................................................6
System Features
Unpacking Instructions ................................................................................................................8
Components ...................................................................................................................................8
Specications .................................................................................................................................8
Physical Characteristics: .................................................................................................................................8
Operating Parameters:.....................................................................................................................................9
Other Features: .............................................................................................................................................. 10
Chemical Compatibility: ................................................................................................................................10
Tests Currently Available: ..............................................................................................................................10
Operating Instructions
Materials Needed .........................................................................................................................11
Sample Preparation and Evaluation.............................................................................................11
Swipe Samples ................................................................................................................................................ 11
Aerosol Samples ............................................................................................................................................. 12
Granular Samples ..........................................................................................................................................12
Liquid Samples ...............................................................................................................................................12
Test Procedures ............................................................................................................................12
pH Test............................................................................................................................................................ 12
Manual Mode (User-timed) Test.....................................................................................................................12
Automatic Mode (Reader-timed) Test.............................................................................................................13
Operating Instructions for Guardian Reader................................................................................14
System Set-up.................................................................................................................................................. 14
Running the Tests.........................................................................................................................15
Guardian Reader Manual Mode Test .............................................................................................................15
Guardian Reader Automatic Mode Test .........................................................................................................17
Aborting a test in progress .............................................................................................................................18
Interpreting your results................................................................................................................................. 18
Disposal information......................................................................................................................................19
Accessing Stored Reports and RFID Data...................................................................................19
To view and print data contained in an RFID: .............................................................................................. 20
To export Reader data to a PC:......................................................................................................................20
System Conguration...................................................................................................................21
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LCD contrast conguration..........................................................................................................21
Autoprint conguration .................................................................................................................................. 21
Time and date conguration........................................................................................................................... 21
System Shutdown ............................................................................................................................................22
Printer Paper Replacement...........................................................................................................22
Maintenance &Troubleshooting
Instrument Maintenance...............................................................................................................23
Instrument Storage.......................................................................................................................23
Routine Operation........................................................................................................................24
Cleaning ......................................................................................................................................24
Troubleshooting ...........................................................................................................................24
Error Messages .............................................................................................................................................. 24
Appendicies
Appendix I: Bio Detect Sampling Procedures
Materials Contained a Box of Test Strips....................................................................................................... 25
Materials Contained in each Standard Collection Kit ...................................................................................25
Swipe Samples (Dry or Wet)..........................................................................................................................25
Liquid Samples ...............................................................................................................................................26
Granular/Powder Samples ...........................................................................................................................26
Solid Samples ................................................................................................................................................26
Dilution Procedure: (1:4 dilution) .................................................................................................................26
Run an additional toxin test at a 1:40 dilution............................................................................................... 27
Dilution Procedure (1:40 dilution).................................................................................................................27
Appendix II: Guardian Reader Screens
Reader Power Up ........................................................................................................................................... 28
System Self Test............................................................................................................................................... 28
Main Menu .....................................................................................................................................................28
Reports Menu .................................................................................................................................................28
Print Menu...................................................................................................................................................... 28
Printing in Progress .......................................................................................................................................28
User ID Screen ...............................................................................................................................................28
Abort Conrmation ........................................................................................................................................28
Conguration Menu .......................................................................................................................................28
Error Screen ...................................................................................................................................................29
Cartridge Expired...........................................................................................................................................29
No Records Found.......................................................................................................................................... 29
Data Records Screen ...................................................................................................................................... 29
Error Reading RFID.......................................................................................................................................29
Blank Strip Test...............................................................................................................................................29
Flow Detection ...............................................................................................................................................29
Test Aborted.................................................................................................................................................... 29
Insert Dosed Cartridge................................................................................................................................... 29
Sample ID Screen ...........................................................................................................................................29
Reading Screen............................................................................................................................................... 29
Test Countdown .............................................................................................................................................. 29
Used Cartridge Alert ......................................................................................................................................30
Apply Sample Now .........................................................................................................................................30
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Automatic Test Recommended........................................................................................................................30
Wait to Apply Sample...................................................................................................................................... 30
Wait until prompted to dose the test strip....................................................................................................... 30
Positive Test Result......................................................................................................................................... 30
Insert Undosed Cartridge............................................................................................................................... 30
Insert an undosed cartridge now....................................................................................................................30
Negative Test Result .......................................................................................................................................30
Appendix III: Guardian Reader Warranties
Guardian Reader Standard Warranty ............................................................................................................31
Guardian Reader Extended Warranty ............................................................................................................32
Appendix IV: Flow Chart & Quick Reference
Guaridan Reader System Testing Flow Chart................................................................................................ 33
Bio Detect Test Strip Quick Reference ...........................................................................................................34
Technical Bulletins (follow the Appendices)
Technical Bulletin 1: Revised User Instructions, Automatic Error Code 202 .............................35
Technical Bulletin 2: Data Transfer from the Reader via USB Port............................................36
Technical Bulletin 3: Use of Multiple Test Strip Types...............................................................37
Technical Bulletin 4: Evaluating Product Claims ........................................................................38
Technical Bulletin 5: Test Strip Storage.......................................................................................40
Technical Bulletin 6: Toxin Dilution Recommended...................................................................41
Technical Bulletin 7: Reader Storage and Maintenance .............................................................42
Technical Bulletin 8: Interpreting Positive Results .....................................................................43
Technical Bulletin 9: Software Update v 1.22 ............................................................................45
Technical Bulletin 10: Guardian Reader Battery Life and Storage Conditions ..........................46
Technical Bulletin 11: Updated Dosing Instructions for Bio-Detect Test strips..........................47
Alexeter Technologies, Wheeling, IL, USA
847-419-1507 Toll Free: 877-591-5571
Email: service@alexeter.com Web: www.alexeter.com
© This Guardian Reader Operation Manual is the copyrighted prop-
erty of Alexeter Technologies, Wheeling, IL, USA. It may not be cop-
ied in any manner without Alexeter’s written permission.
Guardian Reader™, Guardian Reader System™, and Bio Detect Test™ are trademarks of
Alexeter Technologies. All other trademarks are the property of their respective owners.
Alexeter
Technologies LLC
Commerical Biological Defense Systems
Chapter
1
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 Identication (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 identication screening device. It is intended only for use by
trained personnel and only for use in the eld to perform rapid analysis
on environmental samples that may contain biological threats. It is
NOT intended for conrmatory 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 eld.
Although the Guardian Reader has been shown to provide a reliable
and accurate representation of results in laboratory and eld 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 identication of biologi-
cal agents, in conjunction with an analytical measuring instrument,
Page 6
using the same proven methods have been employed for over twenty
years in the medical diagnostic’s industry. The System is comprised
of disposable, single-use test strips and the portable test strip analyzer
(the Guardian Reader manufactured exclusively by Alexeter Technolo-
gies).
Principles of the Immunoassay Test Strip
Note: Always refer to the test strip’s package insert for the latest prod-
uct information!
The Test Strip is a rapid qualitative test (or assay) to detect the
presence of biological threat agents in aqueous environmental samples.
See the “System Features” section, below, for a complete list of tests
available.
The test utilizes a combination of monoclonal and polyclonal an-
tibodies to selectively detect the presence of biological threat agents in
aqueous samples. The test is conducted by dispersing the suspect mate-
rial in Bio Detect Sample Buffer™, then adding this mixture into the
test strip sample port and observing for the formation of colored lines.
At the beginning of the test, the antibody colored conjugate
migrates via capillary action along the membrane, reaching antibodies
immobilized in two areas on the membrane. A positive specimen reacts
with this biological agent-specic conjugate and forms a colored line
in the sample area of the test strip. This is the sample line. The ab-
sence of this colored (sample) line indicates a negative result. To serve
as a control for the procedure, a colored line in the control area must
always appear regardless of the absence or presence of specic bio-
logical agents in the sample. This is the control line. No test may be
considered valid without the presence of the control line. See Figures
1& 2 and also the ”Interpreting Your Results” section, below.
Principles of the Guardian Reader
The Guardian Reader is a precision analytical instrument may be
operated in either of two modes; Manual Test mode or Automatic Test
mode.
In Manual Test mode, the test strip is inserted into the Reader 15
minutes after the sample was added to it. This is called a “dosed” test
strip. In Automatic Test mode, a fresh, unused (“undosed”) test strip in
inserted into the Reader. The Reader will then direct the user with step-
by-step instructions on the screen. As the last step in either mode, the
Guardian Reader will analyze the test strip and report the results.
The Guardian Reader uses an optical diode-array detector to rap-
idly determine the test result by measuring the line density across the
Test Strip. The resulting sample value is compared to a programmed
Page 7
threshold value that is stored in the test cartridge’s RFID. If the sam-
ple value from the test is determined to be above the threshold value,
a POSITIVE test result is displayed and the Reader’s audio alarm will
sound.
The Guardian Reader provides more objective results than the
human eye, especially under difcult lighting conditions or when low
concentrations of the biological agent have been detected.
At high concentrations of the target biological agent, easily iden-
tiable visual bands can be seen on the Test Strip. Low concentrations
of the target agent and/or poor lighting conditions can make such a
visual determination difcult, if not impossible. The Guardian Reader
provides the ability to objectively and reproducibly identify biological
agents at much lower concentration levels than can be easily seen with
the human eye. In low light or critical situations, the Guardian Reader
provides added assurance that test results are correctly reported.
Test strips containing the Radio Frequency Identication (RFID)
chip provide built-in batch calibration, sample test tracking and data
output features that can generate evidentiary documentation for sample
chain-of-custody assurance and easier record keeping.
CRITICAL: Please take time now to read the
Alexeter Technical Bulletins at the end of this
manual. Technical Bulletins are intended to
alert users to recent issues regarding the use
of the Guardian Reader System. Also visit our
website: www.alexeter.com for the latest infor-
mation.
Please check our web site regularly for new Technical Bulletins
and the most recent copy of this manual. To receive updates automati-
cally via email, sign up for updates at our website: www.alexeter.com.
CAUTION: Alexeter Training Strips are used to provide training
in sampling, testing and evaluation techniques. Training positive
strips are intended to provide positive results for training purposes.
In order to minimize the possibility of obtaining a spurious result in
the eld, either positive or negative, do not store Training Strips near
your other test strips. Do not carry Training Strips on your response
vehicle. Keep them in a separate, secured location.
Page 8
II – System Features
Unpacking Instructions
Open the carrying case on a level surface by lifting each latch
upward. Because the case is air- and water-tight, it may be necessary
to release pressure before the case can be opened. To do so, rotate the
pressure release value (the round knob located under the case handle),
counter-clockwise to release pressure. Remove the Guardian Reader
and power adaptor. Place the Reader on a level surface.
Components
Each Guardian Reader purchase includes the following items:
• Test Strip Reader
• Watertight, impact-resistant carrying case with pressure release
valve
• 120-240V International power adapter
• Laminated Quick Reference Instructions w/ Flow Chart
• Operating Manual
• Two (2) rolls of thermal printer (2.25” wide x 24’ long, 1”
diameter), contact Alexeter for re-ordering information.
Specications
Physical Characteristics:
Dimensions: 11 x 9.5 x 3 in.
Weight: 3.5 lbs.
Power supply: The power supply is considered an Installation Cat-
egory II.
Model: Power Supply, Universal 6VDC. Model HUP15A-10-
1B2. Manufactured by International Power Sources.
Voltage range: 100-240. Frequency: 47 – 63 Hz. Sup-
ply current: 2 amps.
Chapter
2
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Battery : 4-AA alkaline batteries (~25 tests with AUTOPRINT
set to OFF position)
Display: 128 x 128 pixel backlit LCD
Output: LCD display, printout and ASCII (comma delimited)
data le transfer via serial port
Alarm: Audio
Operating Parameters:
Although designed primarily for indoor use, the unit may be used
outdoors in appropriate conditions; do not expose the Reader to direct
sunlight or moisture during testing and keep the unit within its operat-
ing temperature range.
Operating Temp. Range: 40° to 105° F
Storage Temp. Range: 15° to 130° F
Humidity Range: 15 to 80% relative humidity, non-condens-
ing.
Altitude Range: 500 ft. below to 6500 ft. above sea level
Ventilation requirements: None
Diffuse sunlight: 1000 W/m2maximum, no direct sunlight
during testing.
Test Time (Manual mode): 3 minutes
Test Time (Auto mode): 15 minutes
Result Range: Positive or Negative
Display Parameters: User ID
Sample ID
Test Strip Type
Date/Time Stamp
Page 10
Other Features:
Memory: Non-volatile memory stores the last 200 test results for
display, reprint and/or transfer to a PC. Records are
then overwritten on a rst-in, rst-out basis.
Data transfer: ASCII le transfer via serial port to the PC. Exports a
comma-delimited le.
Internal Clock: 24-hour factory set clock with 5-year internal clock;
preset to GMT.
• Embedded radio frequency identication (RFID) technology
ensures that the chain of custody is documented for each indi-
vidual Test Strip.
• User is alerted automatically to Test Strip type and expiration
date.
• Limited Warranty; extended service contracts are available.
• UL and CB listed.
• No assembly required.
Chemical Compatibility:
The Reader exhibits no sign of degradation with limited exposure
to the following chemicals:
• Water
• Isopropyl alcohol (70%)
• Chlorine bleach (10%)
Bio-Detect Tests Currently Available:
• Anthrax
• Botulinum Toxin
• Brucella
• Orthopox
• Plague
• Ricin
• SEB (Staphylococcal Enterotoxin B)
• Tularemia
• Training strips
Indice
