Awareness Technology Stat Fax 4200 Operator's Manual
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Awareness Technology Stat Fax 4200 Operator's Manual

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Stat Fax 4200
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© Awareness Technology Inc. 2008 Stat Fax
®
4200 Operator's Manual Revised 2018 Rev. K

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Summary of Contents for Awareness Technology Stat Fax 4200

  • Page 1 Stat Fax 4200 ® MICROPLATE READER ’ ’ © Awareness Technology Inc. 2008 Stat Fax ® 4200 Operator’s Manual Revised 2018 Rev. K...

  • Page 2: Table Of Contents

    TABLE OF CONTENTS 1. Introduction ...................... 1 1.1 Applications ..........................1 1.1.1 Intended Use ........................1 1.1.2 Summary of the Instrument ....................1 1.1.3 Principles of Operation ...................... 2 1.2 Warning Markings Inscriptions d’avertissement ..............3 1.2.1 Safety Symbols Le Symboles de Sûreté ................3 1.2.2 Safety Terms Terminologie de Sûreté...
  • Page 3 3. Cleaning and Maintenance ................50 3.1 Cleaning ..........................50 3.1.1 Exterior ..........................50 3.2 Maintenance........................... 50 3.2.1 Calibration and Linearity....................50 3.2.2 Storage ..........................51 4. Troubleshooting ..................... 52 4.1 Messages and Flags ......................52 4.2 Error Messages ........................55 5.

  • Page 5: Introduction

    1. Introduction 1.1 Applications 1.1.1 Intended Use The Stat Fax 4200 is a compact, microprocessor-controlled, multi-purpose photometer ® system designed to read and calculate the results of assays, which are read in 96 well microplates or strip trays. The Stat Fax 4200 may be used for in-vitro diagnostics.

  • Page 6: Principles Of Operation

    Summary of the Instrument (continued) The Stat Fax 4200 accepts all standard microplates. Trays containing microstrips may also ® be read whether they are 12 wells in length, 8 wells or even partial strips. Pre-programmed Modes - The basic calculations are permanently stored in ...

  • Page 7: Warning Markings Inscriptions D'avertissement

    1.2 Warning Markings Inscriptions d’avertissement 1.2.1 Safety Symbols Le Symboles de Sûreté Symbols that may appear on the product: Les symboles de sûreté peuvent apparaitre sur le produit WARNING Protective Ground CAUTION BIOHAZARD AVERTISSEMENT La Terre Electrique L’ATTENTION BIOHAZARD Refer to Manual Risk of Shock (Earth) Terminal Risk of Infection...

  • Page 8: Safety Precautions

    1.3 Safety Precautions To assure operator safety and prolong the life of your instrument, carefully follow all instructions outlined below. Read Instructions Take time to read this manual carefully before using this instrument. Review the following safety precautions to avoid injury and prevent damage to this instrument or any products connected to it.

  • Page 9: Disposal

    CAUTION! L’ATTENTION! WARNING: If any materials are overturned during operation, immediately set the power switch to OFF. This material should be treated as potentially biohazardous. Appropriate cleanup and disposal of biohazardous waste should be used. Avertissement! Lors du fonctionnement, si on renverse des matériaux, coupez immédiatement le courant.

  • Page 10: Specifications

    1.4 Specifications Photometric Linear Measurement Range: ........0.0 to 4.0 Absorbance Units (A) Photometric Accuracy: ..........+/- (1% +/- 0.010) 0.0 through 1.5 ABS +/- (2% +/- 0.010) 1.5 through 3.0 ABS Stability: ..............Drift of no more than 0.005A in 8 hours Light Source: ..............
  • Page 11 Software Speed: ................ Reads absorbance of 96 wells in about 10 seconds Calculation Modes: ............. Factor, Single Standard, Point-to-Point, Regression, Cubic Spline, Cut Off Mode Test Storage: .............. Stores 120 tests; stores all parameters including wavelengths, calculations, unit codes, linear and normal ranges, standard values, test names, and previous standard curve.

  • Page 12: Installation

    1.5 Installation 1.5.1 General Carefully unpack the instrument, removing it from its plastic bag. Report any damage to your freight carrier at once. Retain the original packing material for future use in the event that the instrument is shipped to another location or returned for service. Items packed with the instrument include: 1.5.2 Installation/Preparation Instrument Placement...

  • Page 13: Load Paper

    Power Cord With the power switch in the OFF [down] position, insert the DC Requirements connector attached to the end of the power supply module cable to the instrument. Insert the mating end of the AC power cord to the inlet of the power supply module, and plug the other end of the AC power cord into an AC outlet.

  • Page 14: Touch Screen Description

    1.5.4 Touch Screen Description The touch screen responds to touch pressure which causes electrical contact between the conductive and resistive layers. The touch screen provides the following advantages: • High touch resolution • Pressure sensitive, works with any stylus • Not affected by dirt, dust, water or light •...

  • Page 15: Checkout Procedure

    Figure 1.7-1 Power up Screen Display door opens and microplate tray extends out. Click Tray In and make sure door closes. Stat Fax 4200 Ver: Eng-01.26.00 Before running any assays, read at least one plate in Laboratory Name (if defined)

  • Page 16: Operating Procedures

    2. Operating Procedures 2.1 Operating Precautions Avoid lifting, leaning or turning the instrument over when a plate is in place. • Be sure to run a sufficient number of controls in each assay. If controls are not within • their acceptable limits or if incomplete, disregard test results. 2.2 General Selections For every test, the instrument will require a mode selection and filter combination.

  • Page 17: Main Display Menu Options

    2.3 Main Display Menu Options The Main display menu options are: • Run Test explained in Section 2.3.1 • Settings explained in Section 2.3.2 • Manage Tests explained in Section 2.3.3 • Utilities explained in Section 2.3.4 • Tray In – the plate carrier transports the plate into the and the door closes •...

  • Page 18: Run Test

    2.3.1 Run Test The Run Test feature allows the operator to recall user tests that have been stored in the instrument’s memory (see example in Figure 2.3.1-1). The Stat Fax 4200 stores up to ® 120 complete test setups in nonvolatile memory, making it easy for the user to recall complete test configurations.

  • Page 19: Settings

    2.3.2 Settings Select the Settings option on the main display screen and the Unit Settings will display: Unit Settings Arrow Keys: Utilize the Adjust Date and Time arrow keys to scroll up and down the list of options or Printer Setup press the option directly from the list;...

  • Page 20: External Output

    2.3.2.1 External Output To enable output to be sent to a personal computer, a user must use a software application such as SF_Capture to transmit and store data from the Stat Fax ® 4200 and have the following in place: •...

  • Page 21: Manage Tests

    2.3.3 Manage Tests Detailed descriptions of the Modes of Operation may be found in Section 2.5. Select Manage Tests on the Main display screen and the following options will display: Create Test Multi-Test Edit Test Clone Test Delete Test Print Test List Exit Figure 2.3.3-1 Manage Tests options The functions of the Manage Tests options are:...

  • Page 22: Multi-Test

    Feature Function Create Test • Set Blank Minimum and or Maximum (Continued) • Set Normal Range Low and or High • Define Valid Range Low and or High Edit Test Used to change test programming. Editing a test will erase any stored blank or standard values for that test Delete Test Allows selection and deletion of user programmed and stored...
  • Page 23 Multi-Test (Continued) Example 1 1) Two tests with different wavelengths have been selected to run. 2) Select “Read Plate” and the first test will run. When that test is done, use the “Results” button to printout out data. (Print Plate can be used to verify well and well absorbance reading location.) 3) The next test will be recalled and run automatically.
  • Page 24 Multi-Test (Continued) Example 2, 1) Three tests – 2, 1 and 3 - were selected to run; 2) Reading of the Standards in the second test, TSH, results in an invalid curve. 3) The next test in the plate will not run. Multi-test mode is ended. Stat Fax ®...

  • Page 25: Utilities

    2.3.4 Utilities Select Utilities from the Main display screen and Utility Menu options used for diagnostic purposes will display. The arrow keys control movement up and down the list of options as well as using the edge of the list to scroll up and down. To select an option from the list, press the Select button.

  • Page 26: General Operation

    2.4 General Operation 2.4.1 Bichromatic Differential Operation The option to operate this instrument using differential absorbance readings is available for every mode. The absorbance readings at the differential wavelength are subtracted from the absorbance readings at the operating (primary) wavelength. Use of the bichromatic differential absorbance values corrects for optical imperfections in the plastic wells and removes the effects of meniscus and turbidity.

  • Page 27: Locating Controls

    Loading & Formatting a Plate (Continued) When using a strip tray, make sure wells are pushed down into tray so that they will not cause the plate to jam on entry. Use care that well tabs do not extend over other wells. Do not place the tabbed ends of strips in row 1;...
  • Page 28 A new screen will open up showing the current plate map (Figure 2.4.2.1-2). Controls can be placed anywhere on the map by manually selecting a well location. The well location selected will then be displayed in the box “Location”. In the example below, a cutoff mode assay is being run and strips are to be read in the 8 way read direction.

  • Page 29: Reading A Plate

    2.4.3 Reading a Plate Select and confirm a stored test, or create a new test. The display will show the plate, indicating where Blanks, Standards and Controls are located. The example below (Figure 2.4.3.-1) shows the layout of a Point to Point mode assay that has duplicate Blanks, 5 Standards, using all three Controls read in duplicate.

  • Page 30: Unit Of Measurement Codes (Unit Code)

    2.4.4 Unit of Measurement Codes (Unit Code) To access the list of Unit Codes, select Manage Tests, select Create Test select any mode except Absorbance, and advance to the Test Definition Final Page. Select the Units field and the list will display. Seven units of measurement designations are stored for labeling the concentration column plus a blank customizable selection.

  • Page 31: Offset Absorbance

    2.4.5 Offset Absorbance If Differential Filter is set to "None", then the Offset Absorbance field is displayed. TEST DEFINITION Name Exit Absorbance Mode Primary Filter Differential Filter Blank Edit Offset Absorbance Print Save Test Definition – Offset Absorbance field displayed The user should determine the value of the Offset Absorbance.

  • Page 32: Modes Of Operation

    2.5 Modes of Operation Mode Function Absorbance See Section 2.5.1 - Absorbance mode reads and prints the monochromatic or bichromatic differential absorbance at the user- selected wavelengths. Blanking is optional. Most Assays require a mode other than Absorbance Mode. In this mode, no calculations are made - only absorbance values are reported.
  • Page 33 Regression See Section 2.5.4- In Regression mode, the instrument accepts a number of Calibrators and calculates concentration values based on a best-fit curve (linear regression). Cubic Spline See Section 2.5.4– Cubic Spline Mode accepts a minimum of 3 and a maximum of 8 calibrators and calculates concentrations based on the Cubic Spline (constrained) calibration curve.

  • Page 34: Absorbance Mode

    2.5.1 Absorbance Mode NOTE: Every user should begin by learning to use the Absorbance Mode. Absorbance mode will read and print sample absorbance values at user selected wavelengths. All of the other modes that follow function the same way but use the measured absorbance to calculate final results.

  • Page 35: Blank

    2.5.1.2 Blank The Test Definition Blank screen will display when the Blank field is selected. This screen allows for the Blank setting to be enabled (Yes or No); and for inputting the number of Replicates. Press the Done button when editing is completed. TEST DEFINITION Blank Enabled # Replicates...
  • Page 36 Factor Mode (Continued) The Test Definition 2nd page will display and allow editing of Factor and Controls. Use the arrow keys to advance through the options, press the Edit key to change the values displayed on the screen. NOTE: The Factor comes from the assay package insert or from a previous assay in the Single Standard Mode.
  • Page 37 Factor Mode (Continued) The Factor Mode Test Definition Final Page will display and allow editing of Interpretation Mode, Units, Decimals, and number of Sample Replicates. Selecting the Units field on the Factor Mode Test Definition – Final Page will display a list of seven measurement designations including a customizable selection, which are stored for labeling the concentration column (see Section 2.4.3 Unit of Measurement Codes).

  • Page 38: Single Standard Mode

    2.5.3 Single Standard Mode To operate in Single Standard Mode, select Manage Tests and then select Create Test. The Test Definition screen will display. Select the mode field and the Select Mode screen will display the list of modes. Use the arrow keys to scroll through the mode selections to the desired selection and press Select, or use the stylus to highlight Single Standard.
  • Page 39 Single Standard Mode (Continued) Selecting any of the Control fields will open a Test Definition Control screen with options to enable the Control (Yes or No), input the number of Replicates, Name the Control, input a Low and a High Range, set the Action to Take (Warn, Continue or End Test), input a Lot Number, input an Expiration Date, and input a Location.

  • Page 40: Multi-Point Modes (Point To Point, Regression And Cubic Spline)

    Single Standard Mode (Continued) Selecting the Interpretation Mode field will open the Test Definition Interpretation screen for editing Interpretation controls. Use the arrow keys to advance through the options, press the Edit key to change the value of the selection. Press the Done button when editing is complete.
  • Page 41 Multi-Point Modes (Point to Point, Regression and Cubic Spline) (Continued) The Test Definition first page displays the available options. TEST DEFINITION Name Exit Point to Point Mode Primary Filter Differential Filter Blank Edit Offset Absorbance 0.000 Print Save Test Definition – 1 page with Offset Absorbance field displayed If Differential Filter is set to "None", then the Offset Absorbance field is displayed The Test Definition 2nd page includes use of % Absorbance, number of Standards,...

  • Page 42: Absorbance

    2.5.4.1 - % Absorbance The % Absorbance option is used with multipoint uptake assays. % Absorbance assigns a value of 100% to the first Standard, which must be entered from darkest to lightest. An additional calculation (%A/A0) is calculated, which is the absorbance of the sample divided by the absorbance of the first calibrator, or “percent of first calibrator”.

  • Page 43: Editing A Curve

    2.5.4.2 – Editing a Curve When Duplicate Standards are used, the curve may be edited by deleting one of any pair of standards. For Point to Point and Regression Modes, the minimum is two; for Cubic Spline Mode, the minimum is three. Once the curve has been read, select the ‘Edit’...

  • Page 44: Select Axes

    2.5.4.3 – Select Axes Axes selections include linear-linear, ln (= natural log)-linear, linear-ln, or ln-ln calculations. A logit-log calculation is also available. Absorbance, or ln of (1000 * absorbance), is always on the “Y” axis. Concentration, or ln of concentration, is always on the “X”...
  • Page 45 Select Axes (Continued) The Log / Logit option is available under the Point to Point Mode, Regression Mode, and the Cubic Spline Mode. Concentrations must be greater than zero in this axes mode. The program automatically increases the number of Standards by one. SELECT AXES Log / logit option –...

  • Page 46: Controls

    2.5.4.4 – Controls Selecting any of the Control fields will open a Test Definition Control screen with options to enable the Control (Yes or No), input the number of Replicates, Name the Control, input a Low and a High Range, set the Action to Take (Warn, Continue or End Test), input a Lot Number, and input an Expiration Date.

  • Page 47: Cut Off Mode

    Controls (Continued) Editing the Interpretation Pos/Neg field will display the Interpretation Normal option for inputting Normal Range Low, Normal Range High, Valid Range Low, or Valid Range High. Press the Done button when editing is completed. TEST DEFINITION Interpretation Normal Interpretation Normal Range Low Normal Range High...
  • Page 48 Cut Off Mode (Continued) The Cut Off Mode Test Definition first page displays the available options: Name, Mode (Cut Off), Primary Filter, Differential Filter, and Blank. Enter wavelength and blank as shown in Section 2.5.1 Absorbance Mode. TEST DEFINITION Name Exit Cut Off Mode...
  • Page 49 Cut Off Mode (Continued) Selecting any of the Control fields will open a Test Definition Control screen with options to enable the Control (Yes or No), input the number of Replicates (1 to 5), Name the Control, input a Low and a High Range, set the Action to Take (Warn, Continue or End Test), input a Lot Number, input an Expiration Date, and input a Location.
  • Page 50 Cut Off Mode (Continued) Set the Controls by selecting the appropriate control field. Note: When setting the Controls, if there are Replicates, the Location will be the starting location. If the Controls or their Replicates overlap due to the plate setup, an error flag will display while running the test to warn the operator.
  • Page 51 Cut Off Mode (Continued) COV Formula Explanation Y * mean(PC) +F • Use this equation if only a positive control is used to determine the COV. • For interpretation, you may choose either the Regular Cut Off Mode (positive >= cutoff, negative <...
  • Page 52 Cut Off Mode (Continued) Selecting the QC Criteria field opens the Test Definition Cutoff Quality screen: (mPC / mNC): Enter the lowest Backup to be used in case acceptable ratio for controls read are too high or TEST DEFINITION Cutoff Quality the mean of the too low.
  • Page 53 Cut Off Mode (Continued) By selecting Pos/Neg, Positive and Negative Interpretations can be entered. It is not necessary to enter both Positive and Negative. These can also be set to be evaluated in the reverse, where Positive is LESS than or equal to (<=) the value entered. NOTE: Double check that the COV calculations and...

  • Page 54: Cleaning And Maintenance

    3. Cleaning and Maintenance 3.1 Cleaning 3.1.1 Exterior CAUTION: Solvents such as acetone or thinner will damage the instrument! Use only water and recommended cleaners! Avoid abrasive cleaners. The display area is liquid-resistant, but is easily scratched. The exterior of the instrument may be cleaned with a soft cloth using plain water. If needed, a mild all-purpose (nonabrasive) cleaner may be used.

  • Page 55: Storage

    Calibration and Linearity (Continued) Pipetting errors can be identified by comparing duplicate readings. The instrument should give the expected value ± (1% of the expected value + .01A). For example, if the 1/4 dilution reads .520 A, then you can expect your 1/2 dilution sample to read twice as much or 1.04 A ±...

  • Page 56: Troubleshooting

    4. Troubleshooting 4.1 Messages and Flags Messages are displayed to alert the operator when certain limits are approached. After displaying the warning the instrument will continue to function normally. Flags are displayed, for example, when an invalid range is entered. They are intended to help the user correct the problem.
  • Page 57 Messages and Flags (continued) Message/Flag Explanation “EQUIV” This is reported when a Sample is less than the POS cutoff and greater than the NEG cutoff concentration. (If it is reversed, then the sample is > value POS cutoff and < value NEG cutoff.) “Factory Settings Restored”...
  • Page 58 Messages and Flags (continued) Message/Flag Explanation “Pos must be greater than or This message appears during test definition when the equal to Neg!” user is defining positive/negative interpretations. A value was entered for both the positive and negative, but the positive value is less than the negative value entered.

  • Page 59: Error Messages

    4.2 Error Messages Error Messages are displayed when the instrument fails to operate correctly. They are intended to help the user locate the problem. Some error messages require action in order to clear. Most require help from technical support. Error Message Explanation Open the Utility menu and select Print Unit Settings.

  • Page 60: References

    Do not turn off the unit until the update is complete 5. References 1. Engineering data supplied by Awareness Technology, Inc. Palm City, Florida (1987 to current date) 2. Data on DRI-DYE Check Strips, provided by Awareness Technology, Inc. Palm City, ®...

  • Page 61: Optional Accessories

    6. Optional Accessories 6.1 Thermal Printer Paper Reorder replacement Thermal Printer Paper Roll P/N 15003. NOTE: The printer manufacturer strongly recommends the use of thermal paper part number 150003 to ensure the best print quality and the effective operation of the print head. Contact your dealer for replacement rolls 6.2 Dri-Dye Check Strips ®...

  • Page 62: Information

    Telephone: USA 772-283-6540 Fax: USA 772-283-8020 E-mail: support@awaretech.com Mailing Address: Awareness Technology, Inc. 1935 SW Martin Highway Palm City FL 34990 USA Important: When contacting us, please have the Model and Serial Number of the Stat Fax 4200 in ®...

  • Page 63: Appendix A Sf_Capture

    8. Appendix A SF_Capture SF_Capture is a software program for use with this reader. Contact your dealer for a copy of the program. To install drivers, refer to Section 2.3.2.1 External Output. Install the program by double clicking on the setup.exe file found in the SF_Capture folder. The installation process is the same as other software –...

  • Page 64: Appendix B Updating Firmware

    9. Appendix B Updating Firmware To update firmware, follow the instructions below. Contact your dealer or technical support if you have any questions. 1. Erase/delete anything that is on the USB pen drive (or any USB drive used). 2. Unzip the attached file and install the folder romimage.42x on the USB drive. 3.

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