Guardian R1000 User manual

DISCLAIMER:
For use by trained personnel
to perform rapid biological
screening on environmental
samples.
Not for conrmatory 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
Specications .................................................................................................................................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 Conguration...................................................................................................................21

Page 3
LCD contrast conguration..........................................................................................................21
Autoprint conguration .................................................................................................................................. 21
Time and date conguration........................................................................................................................... 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 Conrmation ........................................................................................................................................28
Conguration 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

Page 4
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: [e-mail] 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 Identication (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 identication 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 conrmatory 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 identication 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-specic 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 specic 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 difcult lighting conditions or when low
concentrations of the biological agent have been detected.
At high concentrations of the target biological agent, easily iden-
tiable 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 difcult, 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 Identication (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.
Specications
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

Page 9
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 identication (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

Page 11
III – Operating Instructions
The Guardian Reader System includes Test Strips and the Guard-
ian Reader. Instructions for using the Test Strips are detailed below,
followed by operating instructions for the Guardian Reader.
Please see the Product Insert (included in each box of test strips)
and Alexeter’s Testing Flow Chart for complete instructions before
performing these tests. A handy Quick Reference is located on the
back of the Flow Chart. The Testing Flow Chart and Quick Reference
are also contained in Appendix IV of this manual.
Materials Needed
• Bio Detect Test Strip
• Bio Detect Sample Buffer
• Disposable Bulb Droppers (included with each test)
• Disposable Sample Vials
• Disposable Polyester-tipped Swabs
• pH test paper
Sample Preparation and Evaluation
The key to sampling is to sample moderately. The test strips are
very sensitive and require about a microgram of material, dispersed in
one milliliter (ml) of buffer solution to obtain a valid result.
A pH test is also recommended to guard against the inadvertent
evaluation of harsh chemical agents, which can damage the test strip.
Swipe Samples
1) Fill the sample vial with 1 ml of Sample Buffer.
2) Collect the sample by swiping the contaminated surface with
a polyester-tipped swab.
3) Transfer the sample by placing the swab in the vial, then stir
to disperse.
4) Cap the vial and agitate vigorously for 10 seconds.
Chapter
3

Page 12
Aerosol Samples
1) Collect the sample with an air-sampling device, following
manufacturer’s instructions.
2) If necessary, disperse the sample in the Sample Buffer.
Granular Samples
1) Fill the sample vial with 1 ml of Sample Buffer.
2) Add the sample to the vial.
3) Cap the vial and agitate vigorously.
4) Allow any large particles to settle.
Liquid Samples
1) Fill the sample vial with 0.5 ml of Sample Buffer.
2) Add 0.5 ml of the liquid sample to the vial.
3) Cap and agitate vigorously.
Test Procedures
The Guardian Reader will “read” test strips in either of 2 modes:
Manual Mode or Automatic Mode. The Manual Mode allows the
user to obtain quick results by running multiple tests in parallel. The
Automatic Mode ensures precise timing of each test and should be run
whenever a positive result is obtained in Manual Mode.
pH Test
Before dosing a test strip, check the sample’s pH using test paper
(supplied in the Collection Kit). If the pH is not in the range of pH
4 to pH 10, perform a 1:4 dilution. See the Guardian Reader System
Testing Flow Chart (Appendix IV) for details.
Manual Mode (User-timed) Test
1) Inspect the Test Strip protective pouch for damage. Torn or
punctured pouches should not be used. Allow all samples
and test strips to reach room temperature before use.
2) Remove the Test Strip and place it on a at surface.
3) Label the Test Strip with appropriate identiers (sample
source, user ID, etc.).
4) Using the disposable dropper, place 5-7 drops into the
sample port (3-5 drops if using the Alexeter Collection
Swab), lling the sample port completely within a period of
3-4 seconds. When properly dosed, a red liquid will begin
moving across the test strip within 20 seconds.
5) Note the time. If possible, write it on the Test Strip.
6) Wait 15 minutes, then visually inspect the test strip. The

Page 13
only valid result is either one or two lines on a clean white
background. If only one line is present it must be the control
line.
7) Insert the Test Strip into the Reader after the required 15
minutes have elapsed, but no later than 30 minutes after dos-
ing the test strip. Follow the detailed instructions below “To
Run a Manual Mode Test”.
Figure 1: Bio Detect test strip details
Automatic Mode (Reader-timed) Test
1) Inspect the Test Strip protective pouch for damage. Torn or
punctured pouches should not be used. Allow all samples
and test strips to reach room temperature before use.
2) Remove the Test Strip from the foil pouch and place it on a
at surface.
3) Label the Test Strip with appropriate identiers (sample
source, user, etc.).
4) Do not dispense the sample into the sample port! You will
be instructed to do so at the proper time.
5) Follow the detailed instructions below “To Run an
Automatic Mode Test”.
Note: ALL TEST STRIPS MUST BE VISUALLY INSPECTED
BEFORE INSERTION INTO THE GUARDIAN READER. ANY
DUST, DEBRIS OR FOREIGN MATERIAL IN THE TEST STRIP
WINDOW MAY RESULT IN READING ERRORS AND MUST BE
REMOVED BEFORE READING. AVOID DIRECT CONTACT
WITH THE TEST STRIP PAPER MEMBRANE.
ONLY TEST STRIPS WHICH SHOW EITHER ONE OR TWO
LINES ON A CLEAN WHITE BACKGROUND ARE VALID CAN-
DIDATES FOR EVALUATION IN THE GUARDIAN READER.
IF ONLY ONE LINE IS PRESENT IT MUST BE THE CONTROL
LINE.
Test Type Test Window Sample Port
Control Line Sample Line
Figure 3: Guardian Reader
start-up screen
Figure 4: Reader system
test screen
Figure 5: Main Menu
screen
Figure 6: Enter User ID.
The User ID is optional.

Page 14
Operating Instructions for Guardian Reader
System Set-up
• 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 by
rotating the Pressure Release Value (the round knob located
under the case handle). Rotate the valve counter-clockwise
to release pressure. Remove the Guardian Reader and power
adaptor.
• Place the Reader onto a level surface, free from liquid and
debris.
• Connect the Reader to a 120-240V power source. Ensure, if
possible, that a “clean” line power source is used. For ex-
ample, if generator power is employed, a line lter or surge
suppressor is highly recommended. USE ONLY THE POWER
ADAPTOR THAT IS SUPPLIED WITH THE READER OR
DAMAGE TO THE INSTRUMENT MAY RESULT!
• The Reader may also be powered by 4 AA batteries. This will
allow approximately 25 tests to be run before the batteries are
exhausted. To conserve power we recommend that the AUTO-
PRINT option be turned off when operating on battery power.
See the “System Conguration” section, below. If the batteries
fail during a test do not force the strip drawer open to retrieve
the test strip. Replace the batteries and press the “ON” button
to restart the Reader. The test strip drawer will open during
boot up and the test strip can then be retrieved.
• When using “line” power, the Reader will automatically power
up, displaying the startup screen (Figure 3). If running on bat-
teries, press the “ON” button to start the Reader. On power-up,
the Reader will perform a self-calibrating system test (Figure
4) and proceed to the MAIN MENU display screen (Figure 5).
Figure 8: Be sure to orient
the test strip as indicated
above
Figure 9: Enter Sample ID.
Sample ID is optional
Figure 10: The Reader is
evaluating the test strip
Figure 7: Place a dosed
test strip into the Reader Figure 2: Bio Detect test strip results
2A: Positive results: 2 visible lines 2B: Negative results: Control line only

Page 15
Running the Tests
GUARDIAN READER MANUAL MODE TEST
Follow these steps to run a Manual Mode (User-Timed) Test:
1) From the MAIN MENU (Figure 5) display screen, select
“RUN MANUAL TEST” by using the Up (∆) or Down (∇)
arrow keys. Press the “ENTER” button.
2) Enter a user ID number at the prompt, using the numeric
keypad (Figure 6). Press the “ENTER” button.
NOTE: Although user and sample ID Numbers are highly recom-
mended to avoid confusion during subsequent review, use of
this feature is optional. Badge numbers, dates and locations
are suggested identiers.
3) Insert the dosed Test Strip into the Reader at the prompt
(Figure 7). Remember that a dosed strip should be inserted
15 MINUTES after the sample was added to the strip. Press
the “ENTER” button.
CAUTION: False positive results can be obtained if the operator does
not wait 15 minutes before reading the test strip.
NOTE: e Test Strip should be inserted with the indicator strip to the
left and the “sample port” toward the user. See Figure 8.
4) Enter the sample ID at the prompt, using the numeric keypad
(Figure 9). Although you are encouraged to use this feature,
it is optional. Press the “ENTER” button.
5) The Test Strip will automatically move into the Reader. The
screen will display the word “READING” (Figure 10).
6) At this time, the Reader will read data from the RFID con-
tained within the test strip, determining the strip test type
and other test parameters.
7) After approximately three minutes, reading is completed.
The results are automatically displayed on the LCD screen.
If the Reader is set to the default AUTOPRINT setting (see
the “System Conguration” section, below), the results are
also automatically printed on the built-in thermal printer.
NOTE: During printing, the keyboard will not respond to any key-
board input.
Figure 11: A negative result
for anthrax.
Figure 12: A positive result
for anthrax
Figure 13: Press “Enter” to run
another dosed test strip. Press
“Stop” to return to the Main Menu
Figure 14: Insert
a dosed test strip
to run your next
Figure 15: Choose
your next action from
the Main Menu
Enter
Stop
test

Page 16
If the sample value (“SV”) from the Test Strip reading is less than
the threshold value (“TV”), a NEGATIVE test indication is displayed
(Figure 11). If the sample value (“SV”) exceeds the threshold value
(“TV”) setting, a POSITIVE test indication is displayed (Figure 12)
and an audio alarm sounds. Press the “STOP” button to turn the alarm
off.
NOTE: ANY POSITIVE TEST RESULT SHOULD BE IMMEDI-
ATELY REPEATED ON A FRESH TEST STRIP BEFORE ANY
ACTION IS TAKEN. ANY REPEATED TESTS SHOULD BE PRE-
CISELY TIMED USING THE AUTOMATIC MODE TEST. SEE
AUTOMATIC MODE TEST SECTION, BELOW.
All users are strongly encouraged to call Alexeter immediately if
any positive results are obtained to review the operating procedures.
For 24/7/365 emergency service,
Call Toll-Free: [phone]
8) To repeat or run another MANUAL test, press the “Enter”
button after the results have printed. The Display will then
return to the “INSERT DOSED CARTRIDGE” Screen (Fig-
ure 14). From here, follow instructions beginning at Step 3,
above.
9) After all Test Strips have been read and all results have print-
ed, press the “STOP” button to return to the Main Menu.
10) To abort a test during reading, press the “Stop” button and
conrm your choice. For details, see the “Aborting a Test in
Progress” section, below.
12) When running toxin tests (ricin, botulinum toxin or SEB),
prepare a 1:40 dilution and dose another test strip. See Tech-
nical Bulletin #6 for details. Alexeter Technical Bulletins
may be found at the end of this manual. Be sure to check
Alexeter’s website for the latest Technical Bulletins.
NOTE: e operator has thirty seconds to abort the test after [ABORT]
is pressed. If the operator does not conrm the abort request
within the thirty-second period, the test automatically resumes.
Figure 20: The Reader is
evaluating the test strip
Figure 19: Enter a sample
identication number
Figure 18: Place an undosed test
strip in the Reader
Figure 17: Enter a user identica-
tion number (optional)
Figure 16: Reader Main Menu.
Select “Run Automatic Test”

Page 17
GUARDIAN READER AUTOMATIC MODE TEST
Follow these steps to run an Automatic Mode (Reader-Timed) test:
1. From the MAIN MENU display screen, select “RUN AU-
TOMATIC TEST” by using the Up (∆) or Down (∇) arrow
keys (Figure 16). Press the “ENTER” button.
2. Enter a user ID number at the prompt, using the numeric
keypad (Figure 17). You will be reminded NOT to apply the
sample to the strip. Press the “ENTER” button.
NOTE: Although user & sample ID Numbers are highly recom-
mended, this feature is optional. Badge numbers, dates and locations
are suggested identiers.
3. Insert an undosed test strip at the prompt (Figure 18). Press
the “ENTER” button.
4. Enter the sample ID number at the prompt (Figure 19).
Press the “ENTER” button.
5. At this time, the Reader will read data from the RFID con-
tained within the test strip, determining the strip test type
and other test parameters.
6. The Reader will now verify that the test strip is unused (Fig-
ure 21). If the Reader does not nd a new, unused test strip,
you will be prompted to insert one.
7. If a new, unused strip is found, you will be prompted to
apply the sample to the cartridge (Figure 22). Using the
disposable dropper, place 5-7 drops into the sample port
(3-5 drops if using the Alexeter Collection Swab), lling
the sample port completely within a period of 3-4 seconds.
When properly dosed, a red liquid will begin moving across
the test strip within 20 seconds. Press the “Start” button now.
8. The Reader will now enter the Flow Detection phase (Figure
23), verifying that the test strip was dosed and the test started
at the correct time by “watching” for the liquid ow to pass
the sensor. No user intervention is required at this point.
9. The Reader will next begin the timing countdown. The dis-
play will let you know how much time remains until the test
is completed. (Figure 24). No user intervention is required
during this process.
10. After approximately 15 minutes, reading is completed. The
results are automatically displayed on the LCD screen (Fig-
ures 25 & 26). The results are also automatically printed on
the built-in thermal printer, if the Reader is set to the default
AUTOPRINT setting (see “System Conguration”, below).
NOTE: During printing, the keyboard will not respond to any key-
board input
Figure 24: The Reader will
display the time countdown and
then evaluate the test strip
Figure 23: Flow Detection Phase.
The Reader is “watching” for the
liquid front to pass the sensor
Figure 22: Add 4 drops of the
sample to the sample port
Figure 21: Blank Strip Test.
The Reader is making sure
that test strip is undosed

Page 18
If the sample value (“SV”) from the Test Strip reading exceeds
the threshold value (“TV”) setting, a POSITIVE test indication is
displayed and an audio alarm sounds. Press the “STOP” button to turn
off the alarm.
11. To repeat or run another Automatic test, press the “Enter”
button. The Display will return to the “INSERT UNDOSED
CARTRIDGE” Screen (Figure 27). From here, follow the
instructions beginning at step 3, above.
12. After all Test Strips have been read and all results have
printed, press the “STOP” button to return to the Main Menu
(Figure 28).
13. When running toxin tests (ricin, botulinum toxin or SEB),
prepare a 1:40 dilution and dose another test strip. See Tech-
nical Bulletin #6 for details. Alexeter Technical Bulletins
may be found at the end of this manual. Be sure to check
Alexeter’s website for the latest Technical Bulletins.
ABORTING A TEST IN PROGRESS
Follow these steps to run abort a test in progress:
1) You may abort the test process at almost any point in the
testing process by pressing the “STOP” button.
2) Conrm your decision by selecting “Yes” at the prompt
(Figure 29).
3) Press the “Enter” button to return to the MAIN MENU.
INTERPRETING YOUR RESULTS
1) No test result is valid in the visual absence of a strong line in
the control area. If you do not see a control line proceed as
follows:
a. Retest the sample, making sure you are using a fresh
test strip from an undamaged foil pouch.
b. If the sample is very viscous (thick), dilute it 1:4
with Sample Buffer and retest. Remember that the
sample must be able to ow across the strip.
c. If you continue to fail to get a line in the control
area, call Alexeter for instructions.
2) The visual presence of a line in the sample area indicates
the presence of the target material in your test sample. It is
strongly suggested that you retest in Automatic Mode. Call
Alexeter immediately if you verify positive results.
3) The visual absence of a line in the sample area indicates that
the target material is not present or is present at a very low
level in your test sample. Always visually inspect all test
strips to conrm the Reader output.
Figure 25: Posi-
tive test result
Figure 26: Nega-
tive test result
Figure 27: To begin another Auto-
matic Test, place an undosed test
strip in the Reader
Figure 29: Conrm that you wish
to abort the current test
Figure 28: Reader Main
Menu

Page 19
DISPOSAL INFORMATION
• Any materials exposed to potential biological threat agents dur-
ing testing should be disposed of as any other suspected BIO-
HAZARD waste. Consult local regulations for proper disposal
procedures.
• Any Guardian Reader which delivers a positive result, later
conrmed by a certied laboratory, will be replaced at Alex-
eter’s expense.
• All materials supplied by Alexeter (test strips, buffer solution
and sampling materials) are non-toxic and may be disposed of
in the ordinary waste stream. Consult local regulations.
DANGER: The Guardian Reader System™ is used to identify poten-
tial biohazards. Death or serious injury may result from exposure
to biohazardous materials. Handle all suspect material with proper
safety equipment.
ACCESSING STORED REPORTS & R.F.I.D.
DATA
Up to 200 previous test reports are stored in the Reader’s non-
volatile memory. These test report data les can be recalled from mem-
ory, displayed on the LCD screen and re-printed. After a total of 200
data les have been stored on the Guardian Reader, data from new test
les overwrite previous data les. The oldest data le is overwritten
with the newest data le so that the most recent 200 data les always
reside in the Reader’s memory. Loss of power due to non-volatile
battery drainage or dislodging of the battery itself may result in loss
of stored data. Regular backups of stored data are recommended (See
“Reader Data Export”, pg. 27).
To view and print stored reports follow these steps:
1) From the MAIN MENU, select “RUN REPORT” using the
UP (∆) or DOWN (∇) arrow keys (Figure 30). Press the
“ENTER” button.
2) Select “BROWSE TEST RESULTS” using the arrow keys
(Figure 31). Press the “ENTER” button.
3) The display will list (up to) the last 200 tests you have run.
The time, date and sample number are listed for each previ-
ous test on the “DATA RECORDS” screen, beginning with
the most recent test (Figure 32). Using the arrow keys, select
the desired Test Report. Press the “ENTER” button to view
the test details.
4) The selected Test Report will be displayed on the LCD
Figure 33: Test Results detail
screen. Press the “Print” button
to print the test results; press the
“Enter” button to return to the
Data Records screen
Figure 32: The last 200 data
records are displayed here.
Press the “Enter” button to view
any report details
Figure 31: Select “Browse
Test Results” to see a list of
data records
Figure 30: Main Menu screen.
Select “Run Report” to view and
print reports

Page 20
screen (Figure 33). To print the result, press the “PRINT”
button.
5) To access other test results, press the “ENTER” button. To
return to the MAIN MENU, press the “STOP” button.
To view and print data contained in an RFID:
1) Place the test strip you wish to read into the Reader.
2) From the MAIN MENU, select “RUN REPORT” using the
UP (∆) or DOWN (∇) arrow keys (Figure 30). Press the
“ENTER” button.
3) Select “Display RFID Contents” using the arrow keys (Fig-
ure 31). Press the “ENTER” button.
4) The Reader will display the results on the screen. Press the
“Print” button to print the result.
To export Reader data to a PC:
1) Turn the Reader off. Use a standard serial cable (not sup-
plied) to connect the Reader’s serial port to the serial port of
your PC.
2) Turn the Reader on.
3) From the MAIN MENU, select “RUN REPORT” using the
UP (∆) or DOWN (∇) arrow keys. Press the “ENTER” but-
ton.
4) Open an appropriate “terminal” program. The following in-
structions apply to “HyperTerminal” which is supplied with
Windows 98. HyperTerminal is a standard program in all
versions of Windows through Windows XP. HyperTerminal
is not included in Windows Vista.
5) Open HyperTerminal. The full path is: C:\ Program Files\
Accessories\ Hyperterm.exe
6) Type a connection name. “Guardian Reader” is a logical
choice. Select an appropriate COM port and a transfer speed
of 115,200. Consult your system administrator if you are
unsure.
7) Select “Capture Text” from the Terminal Menu. Note the
name and location of the text le you are creating. At the
prompt, click on the “Start” button (in HyperTerminal, not
the Reader!) to initiate the text capture.
8) On the Reader, select “Transfer All Results” using the arrow
keys (Figure 31). Press the “ENTER” button.
9) The data will be transferred (copied) to your PC, the Reader
will also retain its copy of the les.
10) Open the newly created text le with the program of your
choice. Excel is a good choice. Remember that you are
opening a comma-delimited le.