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Guardian R1000 Operation Manual

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DISCLAIMER:
For use by trained personnel
to perform rapid biological
screening on environmental
samples.
Not for confirmatory 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

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Summary of Contents for Guardian R1000

  • Page 1 For use by trained personnel to perform rapid biological screening on environmental samples. Not for confirmatory 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

    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...
  • Page 3 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...
  • Page 4 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.

  • Page 5: Intended Use

    Chapter 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...

  • Page 6: Principles Of The Immunoassay Test Strip

    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.
  • Page 7 In low light or critical situations, the Guardian Reader provides added assurance that test results are correctly reported.

  • Page 8: Ii - System Features

    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.

  • Page 9: Operating Parameters

    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 file transfer via serial port Alarm: Audio Operating Parameters: Although designed primarily for indoor use, the unit may be used outdoors in appropriate conditions;...

  • Page 10: Other Features

    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 first-in, first-out basis. Data transfer: ASCII file transfer via serial port to the PC. Exports a comma-delimited file.

  • Page 11: Iii - Operating Instructions

    Chapter 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...

  • Page 12: Aerosol Samples

    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.

  • Page 13: Automatic Mode (Reader-Timed) Test

    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 Figure 5: Main Menu WINDOW MAY RESULT IN READING ERRORS AND MUST BE screen REMOVED BEFORE READING.

  • Page 14: Operating Instructions For Guardian Reader

    Pressure Release Value (the round knob located under the case handle). Rotate the valve counter-clockwise Figure 8: Be sure to orient to release pressure. Remove the Guardian Reader and power the test strip as indicated above adaptor.

  • Page 15: Running The Tests

    Running the Tests GUARDIAN READER MANUAL MODE TEST Follow these steps to run a Manual Mode (User-Timed) Test: From the MAIN MENU (Figure 5) display screen, select Figure 11: A negative result “RUN MANUAL TEST” by using the Up (∆) or Down (∇) for anthrax.
  • 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.

  • Page 17: Guardian Reader Automatic Mode Test

    GUARDIAN READER AUTOMATIC MODE TEST Follow these steps to run an Automatic Mode (Reader-Timed) test: 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.

  • Page 18: Aborting A Test In Progress

    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. Figure 25: Posi- Figure 26: Nega- 11.

  • Page 19: Disposal Information

    These test report data files can be recalled from mem- ory, displayed on the LCD screen and re-printed. After a total of 200 data files have been stored on the Guardian Reader, data from new test files overwrite previous data files. The oldest data file is overwritten with the newest data file so that the most recent 200 data files always reside in the Reader’s memory.

  • Page 20: To View And Print Data Contained In An Rfid

    Windows Vista. Open HyperTerminal. The full path is: C:\ Program Files\ Accessories\ Hyperterm.exe 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.

  • Page 21: System Configuration

    LCD Figure 35: Select “LCD Contrast” screen. The Guardian Reader comes from the factory with the default to adjust the screen contrast set- ting, select “Autoprint” to change setting for AUTOPRINT as “ON”.

  • Page 22: System Shutdown

    Printer Paper Replacement The Guardian Reader uses 2.25 in x 24 ft x 1 in (W x L x D) ther- mal paper. It is recommended that you use paper with thermal stability to at least 150°...

  • Page 23: Maintenance &Troubleshooting

    Properly repackage the unit per Alexeter specifications (see operating manual). Remove the batteries before storing the Guardian for any extended period. Place a label on the outside of the case stating the date the maintenance was performed and person who performed it.

  • Page 24: Routine Operation

    Reader Cleaning The outer housing of the Guardian Reader can be wiped down with a soft cotton cloth. Spills onto the surface should be immediately wiped off. If any liquid is spilled onto the Reader, it should be powered off immediately and left outside of the carrying case to completely dry.

  • Page 25: Appendix I: Bio Detect Sampling Procedures

    Appendix I: Bio Detect Sampling Procedures Materials Contained in 1 Box of Test Strips • 25 Test Strips • Bottle of Sample Buffer • Disposable Bulb Droppers (contained within foil pouch) • Sterile Applicator Swabs • Sample Vials Materials Contained in each Standard Collection Kit •...

  • Page 26: Liquid Samples

    Appendix I Liquid Samples Fill the sample vial with 0.5 milliliters of the Sample Buffer (0.5 mark on the vial). Add the liquid to be tested up to the 1.0 ml mark on the vial. Close the cap on the vial and agitate vigorously. Using the disposable bulb dropper remove liquid from top liquid layer (below any foam) of the sample vial.

  • Page 27: Run An Additional Toxin Test At A 1:40 Dilution

    Add one drop of the original sample to this vial and agitate for 10 seconds. Dose the additional toxin strip(s) with the 1:40 dilution. Evaluate the tests as per our standard protocol. See the Guardian Reader Manual and the Guardian Reader Testing Flow Chart for details.

  • Page 28: Appendix Ii: Guardian Reader Screens

    Appendix II: Guardian Reader Screens Guardian Reader Screens are illustrated below, with a short explanation for each Reports Menu User ID Screen Reader Power Up Choose the report you wish Enter your user identifi- The Reader is starting up, to see, then press “Enter”...

  • Page 29: Error Screen

    Appendix II Error Reading RFID Error Screen Insert Dosed Cartridge The RFID cannot be read, Insert the cartridge 15 minutes An error has occured, retry after dosing, no sooner. This is a heve you inserted the the step, call Alexeter if the cartridge correctly? Manual Test.

  • Page 30: Used Cartridge Alert

    Appendix II Wait to Apply Sample Used Cartridge Alert Insert Undosed Cartridge You are running an Automatic You are running an Automatic This cartridge has been dosed Test, wait until prompted to dose Test, insert an undosed cartridge and/or “read”. If running an Au- the test strip tomatic Test, insert an undosed test strip.

  • Page 31: Appendix Iii: Guardian Reader Warranties

    For a period of one (1) year, Alexeter Technologies, LLC (“Seller”) warrants that upon delivery at its dock that the Guardian Bio Threat Alert™ Reader shall be free from defects in material and workmanship or from malfunctions under the operating conditions specified in the equipment docu- mentation.

  • Page 32: Guardian Reader Extended Warranty

    For the length of the warranty period, Alexeter Technologies, L.L.C. (“Seller”) warrants that upon delivery at its dock that the Guardian Reader™ shall be free from defects in material and work- manship or from malfunctions under the operating conditions specified in the equipment documenta- tion.

  • Page 33: Appendix Iv: Flow Chart & Quick Reference

    Appendix IV: Flow Chart & Quick Reference Page 33...

  • Page 34: Bio Detect Test Strip Quick Reference

    Quick Reference: Alexeter Guardian Reader ™ See the Guardian Reader Operating Manual for complete instructions. The manual was supplied with your Guaridan Reader. Additional copies are available online at www.alexeter.com or may be obtained by calling Alexeter at 877-591-5571. Start Up 4.

  • Page 35: Technical Bulletin 1: Revised User Instructions, Automatic Error Code 202

    “Start” button. This ensures that the liquid will reach the sensors before the timeout occurs. Therefore, we are changing Step 8 on page 22 of the Guardian Reader Manual to read as follows: 8.

  • Page 36: Technical Bulletin 2: Data Transfer From The Reader Via Usb Port

    Set the port speed to 115,200. Click “OK” From the Transfer Menu, select “Capture Text”. Name the file which will capture the data. “Guardian Data” is a good choice. Be sure to note where the file is being saved. Start the file capture by pressing the “Start” butto n. The PC is now ready to accept data from the Reader.

  • Page 37: Technical Bulletin 3: Use Of Multiple Test Strip Types

    Alexeter Technologies, LLC Technical Bulletin #3 All Guardian BioThreat Alert™ Customers Subject: Use of Multiple Test Strip Types Date: 28 May 2002 It has come to our attention that many users of the BioThreat Alert™ System have been deviating from our training protocols and only running an Anthrax BioThreat Alert™ test strip when testing for unknown powders.

  • Page 38: Technical Bulletin 4: Evaluating Product Claims

    “real world” conditions. In the case of the Alexeter’s Guardian Reader System, our field data surveys from use over the last several years indicate a false-positive rate of less than 0.2% under “real-world”...
  • Page 39 100,000 spores per milliliter of test solution. Fact is, when comparing concentration sensitivity; there is no commercial antibody test system more sensitive than the Guardian System with BioThreat Alert tests. The important point is that the customer needs to demand from the manufacturer what concentration is required to detect the target substance.

  • Page 40: Technical Bulletin 5: Test Strip Storage

    3. The test strips should not be stored in direct sunlight or for prolonged periods of time above 90° F. 4. The Guardian Reader may be stored in the range of 15° to 130° F. 5. Bring the test strips and the Guardian Reader to room temperature before use; the operating range is 59°...

  • Page 41: Technical Bulletin 6: Toxin Dilution Recommended

    3. Add one drop of the original sample to this vial and agitate for 10 seconds. 4. Dose the additional toxin strip(s) with the 1:40 dilution. 5. Evaluate the tests as per our standard protocol. See the Guardian Reader Manual and the Guardian Reader Testing Flow Chart for details.

  • Page 42: Technical Bulletin 7: Reader Storage And Maintenance

    Guardian Reader™ Storage and Maintenance Recommendations Date: 14 March 2003 The following are storage and maintenance recommendations for the Guardian Reader: Storage: 1. Storage temperature range: 15 to 130 °F. 2. Storage humidity; outside storage container: 15 to 80% RH, non-condensing.

  • Page 43: Technical Bulletin 8: Interpreting Positive Results

    24 April 2003 An Automatic Mode test is required to obtain a positive biological screening from the Guardian Reader System. Users of the Guardian Reader System must avoid interpreting “positive” results prematurely, especially if interpreting based solely on the results of a Manual Mode test.
  • Page 44 4. Prepare a 1:40 dilution and dose a second set of toxin tests (ricin, botulinum toxin and SEB). Write the dosing time on each test. 5. Wait at least 15 minutes and no longer than 25 minutes before reading a Manual Mode test with the Reader.

  • Page 45: Technical Bulletin 9: Software Update V 1.22

    To address this issue, we are offering a software update that installs operating system version 1.22 on your Guardian Reader. Version 1.22 allows the user to reset the Guardian’s clock. The software also improves the reliability of the testing procedure, ensuring that expired test strips cannot be inadvertently used.

  • Page 46: Technical Bulletin 10: Guardian Reader Battery Life And Storage Conditions

    Reader has experienced. Warmer storage conditions decrease the life of lithium-ion batteries. Therefore if your Guardian Reader has been stored in a hot climate, often without benefit of air conditioning, or regularly transported in hot vehicle compartments, even in moderate climates, and your Reader is over 4 years old, you are at risk of experience premature internal battery failure.

  • Page 47: Technical Bulletin 11: Updated Dosing Instructions For Bio-Detect Test Strips

    Recommendations The Guardian and Defender User manuals, as well as our Product Inserts, posted on our website reflect this change, A revised Product Insert is also attached to this Technical Bulletin. Download and print the appropriate file, replacing the current manual. Please call Alexeter Customer Service with any questions you have.

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