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Stat Fax 303 Plus

1. C to 40 C Although it may be safe to operate in these conditions it may not be suitable for the performance of your tests check with your supplier Humidity 80 for temperature up to 31 C decreasing linearity to 50 humidity at 40 C Mains supply voltage fluctuations not to exceed 10 of nominal voltage Recommended Environmental Conditions Recommended Operating Temperature 18 35 C Recommended Operating Humidity Less than 80 Optional Accessories Available from your dealer oocooo DRI DYE Check Strips for instrument QC replacement lamps fuses thermal paper serial cable Design and instrument specifications are subject to change without notice Awareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 13 14 Notes Stat Fax 303 Plus Operator s Manual Rev J ST EAwareness Technology Inc 2 0 OPERATING PROCEDURES When reading microstrips the instrument must be programmed to calculate and to label wells and results according to the operator s specifications For test procedures with many entries it is recommended that inexperienced operators prepare a list of their selections before beginning operation Alternately these tests can be stored in non volatile memory to reduce set up requirements to a single step for subsequent uses When tests are recalled from the user menu all of the general selections will have been predetermined Section 2 1 provides informat
2. END function at this time to read only part of a strip by following the instructions in section 2 1 10 Selecting an END location Load the carrier and press the READ key The instrument will then begin to read the first strip and print the results labeling the controls as NC or PO NOTE All controls plus the blank must fit into 8 wells If more are entered Too many controls and TEST ENDED will print and the mode will cancel After the first strip is read the display shows C O Abs OK Y N If the cutoff absorbance value is acceptable press YES C O Abs is stored will print If the cutoff absorbance value is not acceptable press NO If the test is stored the display will show Recall test Y N If the test is not stored the display will show Re start Y N In either case press YES to run the test again press NO to return to the C O Abs OK Y N prompt or press the CLEAR key twice to cancel the mode The instrument will be ready for the next strip when it displays Set Carrier Then Press Enter To continue reading in the C O Control mode load the next strip and press the ENTER key If you want to store this test in your user test menu be sure to store it prior to canceling see section 2 3 1 Storing a Test Press the CLEAR key twice to cancel the mode 2 2 5 Regression Mode Press the MULT key multi point modes to access the regression mode Regression Y N will be
3. CALIBRATION DATA label by using the MENU key and selecting test 212 When the display prompts ABS FACTOR enter the number from the ABSORBANCE line If the message ADJUST OUT OF RANGE appears simply re enter the correct data To print a report of the entered data run test 213 The data in test 213 should match the data from the CALIBRATION DATA label Note When the stored calibration data is lost the absorbance factor is set to 1 000 The instrument will not accept a change greater than 10 900 1 100 for the absorbance factor If the calibration data is lost these limits assure that the instrument requires only minimal adjustment from the keyboard to remain calibrated Note that the number entered in test 212 is multiplied by the current absorbance factor set to 1 when reset Thus running test 212 and entering a factor more than once will result in an incorrect absorbance factor Confirm that the factor is correct by running test 213 3 2 Operating Precautions Most errors in clinical laboratory testing are due not to bad reagents or malfunctioning instrumentation but rather to operator error We have taken several steps in the design of the Microstrip Reader to minimize operator error stable factory calibration automatic zeroing complete operator prompting detailed labeling pre programmed calculations comprehensive visual and audible feedback flags and error messages and minimal maintenance requirements T
4. Carrier Pins lt gt O ZO GOLLL QA Po lt gt lt gt O lt gt lt gt lt gt O ZO lt gt OX y wareness Technology Inc 2 2 Calculation Programs Be sure to familiarize yourself with the general selections in section 2 1 Unless otherwise specified all general selections are available as described In addition all modes may be stored and recalled in the user test menu section 2 3 and any additional prompts that appear in recalled tests are discussed in section 2 3 3 Note that the Absorbance and Uptake Modes do not have curve storage When selected all modes print the date time mode and strip type 8 or 12 The instrument automatically transports the samples through the optical system and back out again with the carrier position and readings displayed and printed simultaneously The instrument reads and prints results of an 8 well strip in about 30 seconds Sample printouts from all modes are found in Section 4 3 Appendix 3 2 2 1 Absorbance Mode In this mode absorbances will be read at the user selected wavelengths and the absorbance will be displayed and printed Use of a blank is optional After the filters are selected the reader displays Set Carrier Then Press Enter Press the BLANK key to blank on the first well Blank s in well 1 is printed Position the carrier in the instrument to read your first strip and press ENTER Absorbance mode does no
5. Negative range enter 1 if you want Negative values to be all values less than the cutoff value The display will then prompt Pos gt X COV X Enter a number which when multiplied by the cutoff value will be the lower limit of the Positive range enter 1 if you want Positive values to be all values greater than or equal to the cutoff value Any samples with absorbances falling between these ranges will be labeled E equivocal The display will show Num of NCs Type in the number of Negative Controls and press ENTER If you select 2 or more wells for each control the display will prompt Check mean Y N Press NO if the criteria apply to the individual wells or YES if the criteria apply to the mean of the wells The display will show mNeg C lt mNeg C gt Type in each value and press ENTER The display will show Num of PCs Type in the number of Positive Controls and press ENTER The display will show Pos C gt Pos C lt Type in each value and press ENTER The total number of controls plus the blank must be less than or equal to 8 If more are entered Too many controls and TEST ENDED will be printed and the mode will automatically cancel Set Carrier to X Then Press Enter is displayed where X is either 1 or A depending on the strip type In Cutoff Mode you may not select additional Controls or Cutoffs Load the first strip into the righ
6. displayed Answer YES This mode calculates a best fit linear equation based upon the standard points It is designed for use with either linear logarithmic or log logit data with absorbance on the y axis and concentration on the x axis After filter selection you are prompted to select your axes type There are five possible formats Linear Log Abs Log Conc Log Log and Log Logit The first choice displayed is Linear Y N where both the absorbance data y and the concentration data x are linear Press YES to select NO to continue Next is Log Abs Y N where the natural log of the absorbance 1000 is plotted against the concentration Note that in logarithmic calculations resulting concentrations will be the same no matter what logarithmic base is used In or log but slopes and intercepts will vary Press YES to select NO to continue Next is Log Conc Y N where absorbance is linear and concentration is logged Press YES to select NO to continue Next is Log Log Y N where the log is taken of both absorbance 1000 and concentration Press YES to select NO to continue Next is Log Logit Y N where a log logit calculation is done The first calibrator must be the 0 calibrator instrument assigned and have the darkest absorbance of all the calibrators Press YES to select NO to recycle the options After the blank and duplicate selections the display prompts for the number of calibrators to be used by displa
7. for data printed in graphical mode i e standard curve plots You may use the serial port with the strip reader to output to a PC but this will require a cable and software not provided with the reader Contact your dealer for the appropriate cable Remember that the microstrip reader only sends data out It does not accept any input from the external equipment The serial connector of the reader is located on the right side of the rear panel Interface DB 9P is configured for data terminal equipment D connector with 9 male pin contacts Pin 1 is ground Pin 2 is the transmit data output ZAwareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 7 PIE Data is transmitted at 2400 baud with 1 start bit 1 stop bit 8 data bits in ASCII Code and no parity bit RS 232 signal levels With both the reader and the receiving equipment turned off plug in both ends of the cable Then turn the receiving equipment on Finally turn on the strip reader It is important to have the receiving equipment ready before starting up the strip reader so that data will not be lost 1 5 3 Internal Printer If there is no paper in the printer install a new roll of paper as follows How to install a roll of paper Remove the paper cover by pinching its sides together and pulling up Unroll about 10 inches 25cm of paper and place the roll on the table behind the instrument A ragged edge or wrinkled paper will be difficult t
8. high and low controls to be used for automatic labeling w wE 10 Stat Fax 303 Plus Operator s Manual Rev J Awareness Technology Inc y PIE The END key allows the user to select the total number of wells to read and print The key assignments for the filters are as follows For all models key 1 is 405nm key 2 is 450nm key 3 is 492nm key 4 is 630nm 6 filter UV key 5 is 545nm key 6 is 340nm 6 filter VIS key 5 is 600nm key 6 is 545nm The 1 and O keys are also used to answer YES and NO questions Awareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 11 1 8 Specifications Photometric Linear Measurement Range n a 0 00 to 3 0 Absorbance Units A Photometric Accuracy coococccccccccnananananaano nono 1 of the reading 0 01 A from 0 to 1 5A a ll ita 2 of the reading 0 01 A from 1 5 to 3 0A A ee ot det enna Drift of no more than 0 005A in 8 hours Warm UP TIME ooccccccccnnnnccnnncncnnnnnnnnnonnccnnnns 45 seconds built in Light SOurce EE Tungsten Lamp Standard Wavelengths Standard 405 450 492 630nm Six Filter UV 405 450 492 630 545 and 340 nm Six Filter VIS 405 450 492 630 600 and 545 nm Type Of Filter 3 cavity hard coat interference filter 10nm half band pass typical VOSSEl E Single double or break apart strips up to 12 wells long 3 strip loading capacity Electronic and Software Speed riie ihia itore eaa Reads calculates and prints results for up t
9. multiplied by the mean of the positive controls and each of these two numbers are added to the FAC to obtain the cutoff value For example your package insert says that the cutoff value is 1 the mean of the positive controls 02 You would enter O for X 1 for Y and 02 for FAC a To select this mode press the CUT key The display will then show C O Control Y N If you wish to use cutoff controls press YES and go on to section 2 2 3 b otherwise when you press NO the display will show Cutoff Mode Y N The cutoff mode uses the equation CO X mNC Y mPC Fac where CO is the cutoff absorbance mNC is the mean of the negative controls and mPC is the mean of the positive controls X Y and FAC are user entered coefficients that can have any positive or negative numerical value including 0 and 1 Press YES After the filters are selected if you chose no differential the Offset Absorbance questions will follow see section 2 4 4 Differential Absorbances for instructions The instrument will give you the choice for reverse cutoff The display will show POS IF gt C O Y N Press YES to choose the regular Cutoff Mode If you press NO the display will show POS IF lt C O Y N Press YES to select the Reverse Cutoff Mode in which absorbances lower than the cutoff are labeled positive Note that in the Reverse Cutoff Mode negative controls have high absorbances and positive controls have low absorbances All rela
10. press the CUTOFF key The display will then show C O Control Y N Press YES After the filters are selected if you chose no differential the Offset Absorbance questions will follow see section 2 4 4 Differential Absorbances for instructions The display will show BLANK Y N Press NO for the photometer to blank on air Press YES and the instrument will display Blank lt The reader will use this value to check that the blank is valid Type the greatest acceptable absorbance value for the blank material relative to air and then press ENTER The blank absorbance will be subtracted from all subsequent wells and will be flagged if it exceeds the set limit The display shows Equiv Range Y N If you answer YES you will be able to enter an equivocal range based on factors of the cutoff value The instrument will prompt NEG lt X COV X Stat Fax 303 Plus Operator s Manual Rev J EAwareness Technology Inc PE Enter a number which when multiplied by the cutoff value will be the upper limit of the Negative range enter 1 if you want Negative values to be all values less than the cutoff value The display will prompt POS gt X COV X Now enter a number which when multiplied by the cutoff value will be the lower limit of the Positive range enter 1 if you want Positive values to be all values greater than or equal to the cutoff value Any samples with absorbances falling between these ranges will be
11. readings will be printed The instrument will be ready for the next strip when it displays Set Carrier Then Press Enter To continue reading in the Cutoff mode load the next strip and press the ENTER key Press CLEAR twice to cancel the mode Reverse Cutoff Mode The Reverse Cutoff Mode provides the ability to interpret low absorbances as positive results Answer N to the prompt POS IF gt C O Y N then answer Y to the prompt POS IF lt C O Y N This will label results P if they are below the cutoff absorbance and N if they are above the cutoff Blank positive and negative controls coefficients and cutoff parameters are entered following the displayed prompts which occur in the same order described in the regular cutoff mode NOTE Be sure to read the lt and gt signs in each display because blank positive control and negative control parameters are entered in a reverse way when using this option Note that the blank is not subtracted from subsequent sample absorbances All other calculations and criteria for an acceptable run in the Reverse Cutoff Mode are identical to those in the regular Cutoff Mode 2 2 4 Cutoff Control Mode C O Control In this mode instead of using the means of the negative and positive controls to determine the cutoff controls labeled CCs are used to do so The positive and negative controls are used for QC criteria To select this mode
12. s light is low or that the light through a specific filter is low You will be given the option to continue to read but this message may indicate decreased linearity You may require lamp replacement or filter replacement Call your dealer for service assistance if needed Reposition Carrier is printed if you attempt to use a carrier position other than the right most for your first strip in a mode Reposition the carrier to the right most position and re run No Carrier is printed if you press Enter to read when no carrier is loaded MEMORY IS FULL is displayed if you attempt to store more tests than are available DO ABS SET TEST 212 is printed when the factory set absorbance gain calibration has been lost from non volatile memory Instructions are located in Section 3 1 Restoring Electronic Calibration 2 4 4 Differential Absorbances This instrument requires the selection of two filters the operating filter and a differential filter Use of the bichromatic differential absorbance increases precision since the element of variation that is caused by imperfections in plastic microtiter strips is removed from the results In order to preserve the sensitivity however it is important not to choose a differential filter where the chromophore being assayed exhibits substantial absorbance A monochromatic option is available for use in scanning the filters independently To look at only 1 filter select O as the differentia
13. the instrument OFF or canceling the mode you may press the ALT key to store a test The display will ask SAVE TEST Y N Press the YES key and the display will ask NAME TEST Y N If you press the YES key the display will show the first portion of a string of characters ABCDEFGHIJKLMNOPQRSTUVWXYZ 0123456789 The flashing cursor indicates the selected character Use the 4 key to move the string to the left and the 6 key to move to the right continue scrolling to the right to access the rest of the text string When the cursor is located on the first character of your test s name press the ENTER key The display will show the letter chosen Again adjust the cursor and press ENTER when you have the next letter selected The display will show the name up to this point If you make an error press the CLEAR key and begin the name again Continue until you have entered the test s entire name up to 12 characters then press ENTER a second time while the name is shown in the display The printer and display will indicate SAVED AS TEST XX where XX represents the next available number The standard curve for an assay is saved with the test and may be used upon recall 2 3 2 Deleting a Test To remove a test from the user menu press the ALT key First you will see SAVE TEST Y N Press NO Then you will see STRIP TYPE Y N Again press the NO key Now you will see DELETE TEST Y N Answer YES When you see DE
14. to damage the Teflon pressure bar located behind the print head If you are unable to clear the jam call your dealer to arrange for service You may continue to use the instrument but results will not be printed on the internal printer After each well is read the result will remain on the display to permit the user to note the result Press ENTER to advance the strip to the next well Problem The lamp does not light Solution Lamp replacement is an infrequent event since the lamp is rated to read over 50 000 strips and your lamp saver feature minimizes idle time Lamp replacement is indicated if the lamp does not light or if the lamp output flag is printed Call your dealer to arrange for lamp replacement service Problem The instrument is several years old and has lost some linearity with time Solution You may need new filters Return the instrument for replacements To retard the deterioration of filters store in an air conditioned environment and do not expose to severe temperature shock Call your dealer to arrange for service Problem Incorrect answers are obtained Solution a Check that the procedures and materials used were valid Turbid or contaminated reagents for example may affect absorbance readings Be sure that you are reading in the specified range of the instrument and using an appropriate chromophore Wells should not have bubbles condensation severe scratches or smudges b Review the procedure for
15. turned off Test selections may be stored so that setup time is significantly reduced when the same assay is repeated Curves are stored in all modes except Absorbance and Uptake The time and date are maintained using this same type of memory Items in non volatile memory may be entered recalled and deleted from memory by the operator following the instructions in this section There are several test numbers reserved for factory use The user should not come across these in normal use however if one is inadvertently selected it may be aborted by turning the instrument off and then back on 2 3 1 Storing a Test Tests are stored in a user test menu by number with an option to store by name The first test that you store will be test number 1 the next test will be test number 2 and so on When you want to recall a test you will be asked to enter the test number A running list or log book should be kept with your instrument to help you identify your numeric entries A sample format for this log can be found at the end of this manual Each time you store a test the instrument will assign the next available test number Remember to update your log The instrument will record the date and time that each test was stored or last modified 32 Stat Fax 303 Plus Operator s Manual Rev J EAwareness Technology Inc PE The ALT key is used to save a test in the menu Any time after you have made your general selections but BEFORE either turning
16. use the point 0 0 you must include it as a calibrator Unknown samples are calculated as follows First the unknown sample s bichromatic differential absorbance is calculated and compared to the calibrator absorbances Then the line segment used for determining the concentration of the unknown is the one connecting the pair of standards whose absorbances are closest above and below the unknown absorbance An unknown sample whose absorbance is greater than the greatest calibrator absorbance is calculated on the line passing through the greatest 2 calibrator points Likewise an unknown sample whose absorbance is less than the lowest calibrator absorbance is calculated on the line passing through the lowest 2 calibrator points The calibrators absorbances must be either decreasing or increasing down the strip i e if the first calibrator is the darkest the second must be the next darkest etc and if the first calibrator is the lightest the second must be the next lightest etc After filter blank and duplicates selections the display prompts for the number of standards to be used by displaying of Cals The number of standards must be less than or equal to eight seven with a blank The display then prompts for unit selection The display will then prompt you to enter the calibrator values As you enter the values the printer will print CAL 1 XXXX acceptable curves CAL 2 XXXX ascending or descen
17. you suspect there is damage to this instrument have it inspected by a qualified service person Do Not Operate in Wet Damp Conditions Do Not Operate In An Explosive Atmosphere Keep Instrument Surfaces Clean and Dry Solvents such as acetone or thinner will damage the instrument Do not use solvents to clean the unit Avoid abrasive cleaners the display overlay 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 or nonabrasive cleaner may be used A 10 solution of chlorine bleach 5 25 Sodium Hypochlorite or 70 isopropyl alcohol may be used as a disinfectant Take special care not to spill liquid inside the instrument Operating Precautions Be sure to run a sufficient number of controls in each assay If controls are not within their acceptable limits disregard test results Biohazard Precautions BIOHAZARD Teal If any materials are overturned during operation immediately set the power switch to OFF 0 This material should be treated as potentially biohazardous Appropriate cleanup and disposal of biohazardous waste should be used ZAwareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 5 1 5 Installation 1 5 1 General Installation Unpack Instrument Carefully unpack the instrument removing it from its plastic bag Report any damage to your freight carrier at once The box should also contain the Ow
18. EE E E E E RE A A A glance a 33 2 3 3 RE CAINE E 33 24 Special A EE 34 242 Clock and Calida dee ee EE 34 DA PM EE 34 ZA Flags and EE 34 2 4 4 Differential ADSOPDANCES inssin iin dished cana NEE ENEE UNENEE 35 249 Calbraton ANG LHe AIG EE 36 510 Additional lips and Infor edel 37 Sl Restoring Electroni EL E 37 3 2 Operating Pr cautions doit 37 3 3 Maintenances nossu neinean a eii ag hed bad a EA RES EEES EEEE REA SARAS 38 SE Troubles EE 39 SE 41 ee EEN 43 4 1 Appendix 1 Dri Dye Check e CT 44 4 2 Appendix 2 Test EE 45 4 3 Appeidiz 3 Sample PINOS ren ee ee 46 4 4 Appendix 4 Contact Information NEE 48 1 0 INTRODUCTION 1 1 Applications PIE 1 1 1 Intended Use This microstrip reader is a laboratory instrument intended for in vitro diagnostic use It is a compact microprocessor controlled photometer system designed to read and calculate the results of endpoint colorimetric assays which are read in microtiter strips This general purpose instrument is intended to be used by trained laboratory professionals 1 1 2 Summary of the Instrument The instrument reads monochromatically or bichromatically and has 3 models a four filter model 405 450 492 and 630 nm a six filter UV model 405 450 492 630 545 and 340nm and a 6 filter VIS model 405 450 492 630 600 and 545 nm Substitute wavelengths in the range of 340 nm to 700 nm are also available on specially ordered models It is designed to accept many single colum
19. LETE TEST in the display again type in the number of the test you wish to delete and press the ENTER key The instrument will display DELETE TEST Y N Press YES to confirm the deletion of this test The test number will then be available for the next user stored test Be sure to update your log The printout will also indicate DELETED TEST XX Pressing NO will abort the deletion To delete all user tests press TEST and enter 183 Erase Tests Y N will be displayed If you select YES the display will return to Ready All stored tests will be cleared 2 3 3 Recalling a Test Use the MENU key to access the user test menu The instrument will display SELECT TEST Type in the number which identifies the desired test and press ENTER Entering the number 99 will print your entire user menu When you select a stored test its test parameters are printed for your review In modes other than Absorbance and Uptake the previous curve is also recalled If a curve has been stored for a test you are given the option of running a new curve and deciding whether to accept the new curve or use the previous curve When you recall a test you are first allowed to use the old curve data will be printed and you may plot the curve If you do not use the old curve you must run a new curve If at this point you do not want to accept the new curve you can restart the test at the beginning again with the option to use the old curve
20. N If you want to read 8 well strips answer YES and see 8 Well Strips A H printed If you want to read 12 well strips press NO and see 12 Well Strips 1 12 printed The display will return to Ready You may change between reading 8 well strips and 12 well strips via the ALT key whenever the display indicates Ready If a test is stored in the test menu the strip type will also be saved Stat Fax 303 Plus Operator s Manual Rev J EAwareness Technology Inc PE ER 2 1 2 Selecting a Mode This instrument contains several pre programmed general purpose calculations which have been selected to facilitate data handling for enzyme immunoassays and other similar tests 1 Absorbance Mode ABS key Calibrator Single Standard Mode STND key Cutoff Mode CUT key Multi Standard Mode MULT key includes Regression Mode and point to point calculation Absorbance Multi Point Mode ABS key Uptake Mode UPT key ply SC SOW ee Ss e Alternately a previously stored test could be recalled from your user test menu at this time Instructions for that are found in section 2 3 User Test Menu MENU key The mode designations are located above the first 6 numbered keys on the keypad When any of these is selected the printer will print the date the time and the name of the mode selected and the display will indicate the next instruction A brief description of each mode follows For a more detail
21. Ooszrereiss COSCON MER BULA GO AED ACL OD o e e bah o O Hd 2 MNS pon A Ana LOS wo E Jl LJ at etd arwzz a m I 1 XI N E E Se g 1 o Mm mi I ee Of SW NN NNI l ASO le e e M zi yw 1 i M Meeda DD HDD ADMIN in x lt w i 1 0 si 0h AT IT TITLES DR E mm l oc OI Oe a int KEEN Ww oD 1 tee OF AVIDI e NMP Zeit al I ro OO UN SO eent EI si e amp 1 1 Wem NOOO NOM ET MAD se ef Lo re y dp a ei ml OMNOPON EN OO ne Sw LL Wrest hte u al Mr N HINSON mN L co NM IAN id z AEn ALTI le D Wri 101 LAME ws acm wi ELA enee sti en gien Il ail Lhe asss ses a SO wi Ise A Gem WI cx mess EN D DR i Or Neh ive LU Lee OI Sor Crain o WAH en on ert Of Leet eet A AN id Det A o E a NO A OU lU zi ANUN AS Naoto Geen IM Peed ee e Stu msi wo Sieg Cl mei Zei mm ORO Olio DOLAN DELT Sl VOTALO 4 3 Appendix 3 Sample Printouts moo teal D ei W i E EZOO OOO Le Mm E Vu a j nm K A ve n EE GEI l me AAA KN F n DOE AN D bi ien D Deg D OI I e o ebe ES a eo eo ee m WD n hak Ye Ot w wi Cesc etc Dec Se e LEI Oo CJ et KA d K DO NOP m Ww ied mics Gaga ct eq dete west oe a oA ei Hammes DN SCH at ue RK a st ma e OD al I n d e rus e o Ke A IO ie Gul o a 2 M Ku KN LUNI et OO OENC fe E eu ts TD gt go OOM hh COL D Oe 4 a 1431 DS ET S D nl ki kat kal EL Lag porta pe JI L t A ee wee oe ee On M we beri La Cl ann na pn a eu eat wi mess 1 1 AAA D s H SSE OD AC zm UN A b
22. R 5 Lu O Hal tea ke Rd MO Ur a DEA E d VM SELON 00 YN te Ne Di Pet leng SOc 2 gt ok Dd N Sates WM et ee L hi E Ate Ieee OM OI ai eg SE S BOAUWUOCoooW AIS GOOD 2 0 CA OCDE g wre EE 4 4 Appendix 4 Contact Information 48 In the unlikelinood that you should ever experience a problem with your instrument please consult your dealer first Dealer If the dealer is unable to resolve the problem support staff at Awareness Technology is happy to assist you and can be reached in the United States by e Phone 772 283 6540 e Fax 772 283 8020 e e mail support awaretech com e Mailing address Awareness Technology Inc P O Drawer 1679 Palm City FL 34991 USA When contacting us please provide the following e the serial number of the instrument e a description of the problem with as much detail as possible e printouts which can be submitted to us by mail fax or email Stat Fax 303 Plus Operator s Manual Rev J EAwareness Technology Inc PE
23. Stat Fax 303 Plus Operator s Manual pe Read Copyright 2001 Doc 303 Revised 04 2007 Rev J TABLE OF CONTENTS IER 1 LiL Appl eationss user Dees EENEG ANEREN ENEE EENS 1 A RE 1 11 2 S mmary of the OSTER ee ee eege 1 1 2 Principles Of Operation viii idad cda 2 13 W rnine MA EES 3 adeleg 3 Le KE 3 LA Safety Pr cautions messe er or E 4 US Installation ia A EE 6 1 5 EE EE 6 MSZ GLAD OE EE 7 1 3 3 Internal Eft cnor einne ea cias 8 1 5 4 Check o t Procedure einn a casa 8 LS Major Parts an E Ee 9 EE Keyboard Functions ET 10 lS Specifications EE 12 2 0 Operating Procedures isis Tea oE 15 REENE Ee ATO N EEE E cass eens Ee 15 DNs Selecting aStip AAA II E E 16 2 1 2 Selecting a Mode muona ae 17 2 1 3 Quitting a Modesa A A Ee 18 LAS EOL aci 18 2 1 3 Selecting a Bla ini as 19 ZNO Selecting Duplicate a 19 GEN i A Ava Oued i E a hoe tal Liking fs Beate A oly oe 20 2 1 8 Selecting Cutoff le Ee 20 2 19 Selecting Control Options 2 a ys eds janes E a es T 21 2 1 10 Selecting an END lO Caton iii 22 2 1 11 Strip Carrier Loading and Positioning ii A Ra 22 SEET 23 2 2 Absorbance Mode sin eira E E E A E E Ed 23 2 2 2 Calibrator Single Standard Mode sui ie 23 X Zout been 24 2 2 4 Cutoff Control Mode C O Control 26 2D i Regression MOTE or dios 28 2 2 6 Point to Polnt MOde vicios iia dde tddi 30 2 2 7 Absorbance Multi Point Mode Ti 31 220 ier EE EE E 32 2 3 User Test E EE 32 23 E e E a Testenn ore aa E 32 LO LS a E
24. The CLEAR key is used to erase a typing error INTRP CNTRL END when information is being entered by keyboard 716 8 H o Clear Pressing twice quits the mode BLANK MENU The ENTER key is used to tell the instrument when you are finished entering information The AUX key is used to turn the lamp on and off The MENU key is used to access tests stored in non The BLANK key allows automatic blank volatile memory Itis also used to enter a decimal point on well A 1 in the ABS Mode for numeric entries The numeral keys serve several functions As numbers they are used to enter test parameters and to make filter selections Any key serving multiple functions will respond to the displayed request for information ABS STND CUT MULT ABS and UPT are the keys used to select a mode of operation ABS stands for Absorbance Mode STND stands for Calibrator Single Standard Mode CUT stands for Cutoff Mode and offers two choices Cutoff Control and Cutoff mode with Reverse Cutoff option MULT stands for Multi Standard Mode and offers two choices regression including linear log and log logit and point to point connection ABS stands for Percent Absorbance Multi Point Mode UPT stands for Uptake Mode Pressing the INTRP key causes the reader to ask for positive and negative cutoff points to be used for automatic sample interpretation Pressing the CNTRL key causes the reader to ask for the locations and acceptance criteria of
25. ad If you are reading multiple strips the instrument will function normally until the partial strip is reached 2 1 11 Strip Carrier Loading and Positioning The three position carrier 12 well standard 8 well available as an accessory fits into the instrument by placing the carrier s groove over the bar on the instrument Place your strip such that the blank well or first well is located in the well closest to the carrier groove If using break apart wells in the 12 well carrier start from the front of row A and fill all 12 locations then begin at the front of row B etc and continue until done Ensure that the wells are firmly placed in the carrier wells that are not fully seated may be seated too high to enter the instrument s optical system Slide the carrier to position the strip you wish to read in the center of the instrument s read area A panel with a notch assists you in lining up your carrier align the strip you are reading with the notch The instrument requires placement of the first standards in strip 1 A but has no specificity for subsequent strips The printout will show the location of the carrier for each strip read Note The holes at the front of the carrier are used to determine carrier position Ensure that these holes are not blocked or obscured by markings on the end of strip tabs Stat Fax 303 Plus Operator s Manual Rev J Groove fits Over bar in instrument 12 Way Carrier STANDARD
26. anual Rev J 3 1 4 Safety Precautions To assure operator safety and prolong the life of your instrument carefully follow all instructions outlined below Read Instructions Review the following safety precautions to avoid injury and prevent damage to this instrument or any products connected to it To avoid potential hazards use this instrument only as specified For best results familiarize yourself with the instrument and its capabilities before attempting any clinical diagnostic tests Refer any questions to your instrument service provider Servicing There are no user serviceable parts inside the instrument Refer servicing to qualified service personnel Use only factory authorized parts Failure to do so may void the warranty Personal Protective Equipment Many diagnostic assays utilize materials which are potentially biohazardous Always wear protective apparel and eye protection while using this instrument Follow Operating Instructions Do not use the instrument in a manner not specified by the manual or the protection provided by the instrument may be impaired Use Proper Power Cord Use only the power cord specified for this product and certified for the country of use Ground the Product This product is grounded through the grounding conductor of the power cord To avoid electric shock the grounding conductor must be connected to earth ground An alternate method is to attach a ground strap from the external grounding term
27. ate either as day month year or as month day year To select a date format first press the MENU key and then enter test 100 The display will indicate the use of the O key to pick the MM DD format and the use of the 1 key to select the DD MM format Use the 1 or O key to choose and then press ENTER The display will return to Ready Once set the time and date will not be lost when the instrument is turned off or unplugged The time will be displayed whenever the instrument displays Ready The time and date will be printed on all assay reports on either printer The date last modified will be stored with each test in the menu 2 4 2 Lamp Saver To prolong the lamp life the instrument is programmed to turn off the lamp automatically after a few minutes of idle time The lamp automatically comes on when you enter a mode or press ENTER to continue reading in a mode in which the lamp has timed out You may also press AUX to turn lamp on or off Pressing the ENTER key when Set Carrier is in the display will cause the lamp to turn on and warm up After the lamp warms up for 45 seconds the reader will proceed to operate in the previous mode with no need to re blank or recalibrate 2 4 3 Flags and Error Messages Flags are printed messages or labels used to alert the operator of special conditions such as approaching limitations After printing the warnings the instrument will often continue to perform It is the operator s respo
28. automatic comparison If so what are the limits 10 Will a cutoff value be used to label any samples as positive If so the value which begins the positive range will be required 11 Will a cutoff value be used to indicate negative samples or define an equivocal zone If so results less than what cutoff should be labeled as negative 12 Will you be running partial strips If so you may want to assign an END location ZAwareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 15 PIE 13 Will this test be stored If so you must remember to store it before you cancel the mode 14 For modes using duplicate calibrators the instrument will ask you if you accept the standard curve before proceeding What criteria will be used to determine bad curves Then you will be asked which points you wish to delete Again some preestablished criteria for selecting bad points and perhaps a maximum number of acceptable deletions might be needed NOTES 1 For the purposes of this manual the terms standard s and calibrator s are used interchangeably to designate reference materials of known concentrations The terms specimen s and sample s are also used interchangeably to mean materials of unknown concentrations 2 Pressing the ENTER key will bypass many unwanted options To begin turn the instrument on and perform the Check Out Procedure Section 1 5 4 When it is finished the ins
29. ay not delete an entire point When you have finished deleting wells press the ENTER key again The standard curve will be recalculated showing an X beside the deleted well s If one of a duplicate pair is deleted the remaining point will be considered as the value for that standard The new slope intercept and correlation coefficient will be printed Again the operator will have an opportunity to see the graph and to edit This may be repeated as many times as desired until either an acceptable curve is obtained or the mode is canceled To continue reading specimens answer NO to the question DELETE WELLS Y N The instrument will be ready for the next strip when it displays Set Carrier Then Press Enter To continue reading in the Regression mode load the next strip and press the ENTER key Press CLEAR twice to cancel the mode ZAwareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 29 PIE 2 2 6 Point to Point Mode Press the MULT key and answer NO to the display Regression Y N The next display is Pt to Pt Y N Press YES to select the point to point mode The Point to Point Mode is a multi point calibrator mode that allows the operator to enter several different calibrator concentrations These are used to calculate the concentrations of unknown samples according to Beer s Law The resulting calibrator curve is a series of line segments connecting the calibrator points If you wish to
30. blanking Remember to use the same volume for the blank and the samples c Be certain that reagents are dispensed into the correct wells Refer to the operating instructions for each mode regarding correct placement of the blank and calibrator materials ZAwareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 39 PIE d Check the tapes to be sure that no flags were printed that would indicate improper results See section 2 4 3 for a review of flags and error messages IF THE INSTRUMENT CONTINUES TO MALFUNCTION CALL YOUR DEALER TO ARRANGE FOR SERVICE Problem The instrument lacks reproducibility Solution a Check that the substance is not affected by the warming of the lamp First perform the instrument CHECK OUT PROCEDURE in section 1 5 4 to ensure proper operation If the instrument is acceptable insert a strip with water in all wells read it several times and observe whether or not the drifting disappears A strip of 12 wells of uniformly pipetted water read in the absorbance mode and blanked on the first well should consistently provide results within 0 01A b Very high absorbance readings are noisier than lower readings Be sure you are operating within the acceptable range of the instrument For best results make dilutions of very dark samples before reading c Perform the check out procedure to verify good repeatability when reading air Problem The printing is dim or incomplete Solu
31. ce periodically DRI DYE Check Strips are recommended e Appropriate controls should be run with each assay as indicated in the package inserts of the chemistry products used If controls do not give expected results the assay is invalid 3 3 Maintenance 38 It is important to follow the installation instructions carefully using only a suitable power supply and placing the instrument with the proper clearance for good air circulation around it Excessive vibration should be avoided During shipments use the original packing material or other suitable protective foam This reader is essentially a maintenance free instrument To ensure maximum trouble free operation the instrument need only be kept dry Although the filters are well sealed their life may be decreased if the instrument is maintained in a very humid environment greater than 80 humidity Using the instrument in an air conditioned room is recommended for humid climates Extreme temperature shock is also harmful to the filters Maximum changes of 5 C per minute are recommended especially at the lower limits of 50 C where permanent damage may occur The upper limits of adequate performance for the filters are 120 C The instrument is designed for use at 20 C and performs according to specifications in the range of 18 35 C Cleaning should be done only when obviously necessary Use a dry cloth or duster to remove dry dust and dirt Use only a slightly damp soft cloth to
32. cimal point Decimal places for the reported concentrations will be the same as those selected for the calibrator The display will then prompt Cal Limits Y N Select NO to continue or select YES to enter absorbance limits for the calibrator the display will prompt Cal 1 gt Enter the minimum acceptable absorbance value for the calibrator Set Carrier to X Then Press Enter is displayed where X is either 1 or A depending on the strip type Load the first strip into the right most carrier position and press ENTER While the strip is being automatically positioned for reading the display will indicate Positioning Strp ZAwareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 23 PIE 24 The instrument will read the strip and simultaneously display and print the results A letter B will appear beside the first well or wells to indicate blanking The symbol C1 will be printed beside the calibrator well or wells indicating that the well s contained calibrator material The display will then prompt PLOT CURVE Y N Press YES to print the curve Press NO and the display will prompt Accept Curve Y N Press YES if the curve is acceptable Press NO and the display will prompt Re Start Y N Press YES to recall the test or NO to return to the Accept Curve Y N prompt 2 2 3 Cutoff Mode In the Cutoff Mode X is multiplied by the mean of the negative controls Y is
33. clean up spills Water or 70 isopropanol may be used to dampen the cloth Use of other chemicals or abrasive scrubbing may damage the cover Be careful not to soak liquids up under the keyboard overlay If this happens simply allow the keyboard to dry before resuming operation Such a spill does not present a hazard but may cause temporary malfunction of the keys Stat Fax 303 Plus Operator s Manual Rev J EAwareness Technology Inc PE 3 4 Troubleshooting Using the following guidelines simple problems can often be isolated and corrected by the operator If your instrument continues to malfunction you may need to speak with someone from technical services for more information or send your instrument to be repaired Service and repair work should be performed only by trained service personnel Consult your dealer to make arrangements if service is needed Problem Mechanism Error message is displayed Solution Turn the instrument off for about 5 seconds When you turn it back on the cup holder may be driven out very slowly towards the front IF THE INSTRUMENT CONTINUES TO MALFUNCTION CALL YOUR DEALER TO ARRANGE FOR SERVICE Problem PRINTER JAM is displayed Solution This is usually caused by a small piece of paper lodged between the flying print head and the side of the printer mechanism Turn the instrument off Reach into the printer mechanism with a pair of tweezers and carefully remove the paper Take care not
34. d in duplicate you may choose to edit the curve The display will prompt DELETE WELLS Y N Use the YES or NO key to answer If you press NO the instrument will proceed to read and calculate the remainder of the strips If you choose to edit the curve by pressing the YES key the display will ask for the location of the well s that are to be deleted Enter the wells one by one You may delete as many as one from each pair but you may not delete an entire point When you have finished deleting wells press the ENTER key again The standard curve will be recalculated showing an X beside the deleted well s If one of a duplicate pair is deleted the remaining point will be considered as the value for that standard Again the operator will have an opportunity to see the graph and to edit This may be repeated as many times as desired until either an acceptable curve is obtained or the mode is canceled To read and calculate specimens answer NO to the question DELETE WELLS Y N The instrument will be ready for the next strip when it displays Set Carrier Then Press Enter To continue reading in the Point to Point mode load the next strip and press the ENTER key Press CLEAR twice to cancel the mode 2 2 7 Absorbance Multi Point Mode Press the ABS key The Absorbance Multi Point Mode A A Multi Pt is a multi point calibrator mode that allows the operator to enter several different calibrator concentrations The
35. ding CAL 3 XXXX not acceptable where XXXX represents the calibrator values you entered mixed direction Note that the instrument allows calibrator values up to 999999 and calibrators less than 1000 can have up to two places after the decimal point Decimal places for the reported concentrations will be the same as those selected for calibrator 1 After all the calibrator values have been entered the display will prompt Off Curve Ok Y N Press YES if all samples are valid Press NO to flag all samples having absorbance values higher than the highest calibrator or lower than the lowest calibrator Note that the Off Curve flagging feature requires that the calibrators be entered and read from lowest concentration for calibrator 1 to highest concentration for the final calibrator Stat Fax 303 Plus Operator s Manual Rev J EAwareness Technology Inc PE Set Carrier to X Then Press Enter is displayed where X is either 1 or A depending on the strip type Load the first strip into the right most carrier position and press ENTER While the strip is being automatically positioned for reading the display will indicate Positioning Strp After the strip or strips containing the standards are read there will be a pause after the standard curve is read The display will prompt PLOT CURVE Y N Press YES to plot the curve Press NO to continue without printing the curve If calibrators were rea
36. e CNTRL key when Set Carrier is being displayed in any mode except the absorbance mode cutoff mode and cutoff control mode The location of only one well is needed to identify a control being read in duplicate Control locations must be designated to make automatic comparisons to user entered acceptance ranges When you press the CNTRL key the instrument will display CONTROLS Hl 1 LO 0 Press the 1 key and then ENTER to select a positive or high control Press 0 ENTER to select a negative or low control For both high and low controls the instrument will ask for the row and strip number or letter by first displaying ROW A H Type in the row letter and then press ENTER You will see Strip 1 12 Type in the strip number and then press ENTER Note If you are in the 8 well mode the first set of wells right most carrier position will be Strip 1 row A through H If you are in the 12 well mode the first set of wells right most carrier position will be Row A strip 1 through 12 After you locate the first high control the instrument asks for the greatest acceptable value for the high control s by displaying HC Hi gt The upper and lower values which you enter for the positive controls will be considered within range while values lower than the low value or higher than the high value will be considered out of range You must enter the limits using the same concentration units which are used for you
37. e Nee H se lee g all Ee OU Fb OI OI A on wei OI ee ase one Gi 0 EN OI wA me Ue ED IT Peo ren coe o pepe E SE M Mr Ep Amt ih in Lei lU de o un a ma wn Es A hi Col Mea A BI ARI UA toa ye 2 5 F A S 2 mm MEL o aS oe k Ba oo sg e ma e GA AE ea lo OTI o gt w E Nog tmi 8 5 M a d 5 sn Gi 1 I o o eo Hoi CM Cc w Fi i Ga La Lex ba Ka ba P a Oo et D IU Ee z a in gt ici oe MN DD e G Oh O vi We mm cu 10 et Ni Ww a N pue Mm SEO IUl N Rh e bk D Mm om Z 2 ali pon 21 6 171 1 l wd D D D a D D D e e D 4 sees l MAS mO MO Wis Mm OU epa Mrt in O ei QNA 1 wit OG tO AN oO TH Ao Me et 2 o a MIN al Dei amp Gi CP CN M O eE we si Tile a a a a a mou no wih ul t memi mil Oi OU Ot ml St Sil E gt 5 Oh lo tag 6 o a o o a E o g eg PE 1 feet NI MIT tI HE NI MMI g t ei OSHAN peal ei k GON DON ON s E RS CH a Lead kk ZG T T x x T T T E a se DN eise leew NM bi gt Ki by by Ki E d x ML EY eT D LA a hu t iD T Be e P s Kei o OC z I l 3 Zieser e uw l u w se oh CCI Oe ss NOOR UA PH MY oor ee eee eee e Sek Dk 100141 cnNNeenneAaD wi E DONO O a el ONO ei e o CLIO C on Ou Git OI et ec OI ei Ge NADOSO gt slur e ts Stee eh OOI l on e E e ONDNDI OTI l NOAN TN Ss in ke VPI DOUD eat 2 ANNO InI OOONDOMOLNM gm ONEMI KE Ei LOI ANNO Er en Deal NADIE O te an tt Lt LI ed see sx en 4 d sw ess oO ep el n Uz 1 Il LSD AA Ri ei IDA E
38. ead in any combination Blanking on the first well is optional The instrument calculates a cutoff value from the mean of cutoff controls It also checks the individual control wells or the means for QC purposes The user may select Correction factor and equivocal range options These adjust the cutoff value to determine cutoff points for interpretation of subsequent specimens E wareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 17 The Regression Mode accepts calibrators and calculates sample concentrations based on the best fit linear regression Regressions may be calculated for linear or logarithmic data as well as log logit data A blank is optional Duplicates cutoff interpretation and control options are available In the Point to Point Mode several calibrators may be read and a blank is optional Line segments connect the points for subsequent calculation of sample concentrations In the Percent Absorbance Multi Point Mode a point to point curve is generated and the absorbance of the A calibrator is assigned 100 Subsequent absorbances are reported as both concentrations and percents of the A calibrator A blank is optional Duplicates cutoff interpretation and control options are available The Uptake Mode requires one calibrator and no blank Concentrations are calculated based upon a factor which equals the concentration of the calibrator multiplied by its absorbance This factor is divided by each subsequ
39. ed description see section 2 2 In the Absorbance Mode the Microstrip Reader reads and prints the absorbances at the user selected wavelengths Blanking is optional In the Calibrator Single Standard Mode the instrument first accepts a calibrator singly or in duplicate then calculates concentrations based on a single point standard curve passing through the point 0 0 A blank is required in the first well or first two wells if duplicate blank is selected A factor equal to the concentration of the calibrator the absorbance of the calibrator is generated in this mode and then multiplied by subsequent absorbances to determine concentrations Duplicates cutoff interpretation and control options are available In the Cutoff Mode a number of negative controls are read followed by a number of positive controls Blanking on the first well is optional The instrument calculates the mean of the positives and the mean of the negatives It also checks the individual control wells or the means for QC purposes It adds three terms one user entered number X multiplied by the mean of the negative controls another user entered number Y multiplied by the mean of the positive controls and a third user entered number Fac The user may also select an equivocal range This determines cutoff points for interpretation of subsequent specimens In the Cutoff Control Mode negative controls cutoff controls and positive controls may be r
40. elect 405 630nm Then see Set Carrier in the display Now load the empty carrier over the carrier bar and press the BLANK key and the ENTER key The instrument will read air Check that the carrier moves in and back out of the instrument Check that all 8 or 12 of the readings are 0 000 0 005A Poor repeatability of the absorbance readings for air indicates possible electronic problems Stat Fax 303 Plus Operator s Manual Rev J EAwareness Technology Inc PE 1 6 Major Parts and Controls The following labeled sketches will help you to locate and identify the major parts of the microstrip reader More details on the operation of each feature are provided in section 2 Operating Procedures The voltage select switch is on the base The power switch and serial connector are on the rear panel Printer paper well with paper roll cover Cover Optical system under cover Printer paper slot Alpha numeric display Keyboard Carrier track with carrier Place carrier groove over bar E in wareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 9 y 1 7 Keyboard Functions The ALT key is used to enter a negative sign and to access a list of alternate functions such as ABS _STND C ALT saving and deleting tests setting the clock and UT YES 411A 2 8 3 choosing 8 or 12 well strips MULT ABS UPT The PAPER key advances the printer paper forward one line each time it is pressed
41. ent absorbance to determine specimen concentration 2 1 3 Quitting a Mode If a test is to be saved in the user test menu this must be done before canceling the mode See section 2 3 1 for instructions on Storing a User Test To quit a mode press the CLEAR key twice This may be done at any time Mode selection keys will not respond if they are pressed without canceling the previous mode first Press the CLEAR key twice before initiating the next mode 2 1 4 Selecting Filters Each mode begins by asking you to choose an operating filter and a differential filter The filter choices are shown below along with their keyboard assignments Standard Six UV Six VIS Key 1 405nm 405nm 405nm Key 2 450nm 450nm 450nm Key 3 492nm 492nm 492nm Key 4 630nm 630nm 630nm Key 5 545nm 600nm Key 6 340nm 545nm First you will see SELECT FILTER in the display Choose the correct number and then press ENTER After the primary filter has been entered you will see SELECT DIF FILTR Again use the number keys to select the desired filter You may select 0 for no differential filter if monochromatic reading is desired If so refer to Section 2 4 4 Differential Absorbances If you enter an incorrect filter selection press the CLEAR key twice to cancel the mode and then begin again with the primary wavelength Your choices will be printed and the operating mode will resume Stat Fax 303 Plus Operator s Manual Rev J EAwareness Technology I
42. epeatability and lack of stray light Therefore proper use of Dri Dye Check Strips is recommended to assure long term instrument performance verification Dri Dye Check Strips contain 5 absorbance levels of predispensed chromophore with NIST traceable absorbance values assigned Simply add water wait mix and read Using predispensed dyes reduces the degree of pipetting precision required to reconstitute the check set strips Since the strip reader looks through the sample from top to bottom volume is proportional to pathlength and hence to absorbance If a well is reconstituted with too much water the decrease in concentration will be corrected by the increase in pathlength In fact the system is self correcting for random pipetting errors up to 10 The charts and graphs provided in the kit allow instant interpretation of results because they are designed to replace the normal calculations with easy to visualize built in acceptance ranges DRI DYE Check Strips can be ordered from your dealer Available for the following wavelengths DRI DYE Check Strips 405 for 405nm DRI DYE Check Strips 450 for 450nm DRI DYE Check Strips 492 for 492nm Stat Fax 303 Plus Operator s Manual Rev J EAwareness Technology Inc PE 4 2 Appendix 2 Test Log Microstrip Reader Test Analyte SN User Test Menu Log Stored By Date Notes Stat Fax 303 Plus Operator s Manual Rev J Page 45 oo E m am
43. ets these requirements Safety Grounding Do not alter or defeat the safety grounding methods provided To avoid the risk of electric shock the third prong of the AC power plug must be connected to conductive parts internal to the equipment Internal fasteners to grounding points are marked by the IEC 417 symbol 5019 O DO NOT loosen or remove these fasteners or connections An alternate method of grounding is provided by connecting the grounding terminal located on the rear panel to a suitable ground To avoid electric shock the power cord protection ground conductor must be connected to ground 6 Stat Fax 303 Plus Operator s Manual Rev J EAwareness Technology Inc PE Voltage Select Switch Locate the voltage select switch on the rear panel This is a 2 position slide switch that will configure the instrument to accept either 230V or 115V input Do not connect equipment to the power supply before changing the line voltage selection switch UN inna To prevent permanent damage to the instrument this switch must be set for the appropriate input voltage before powering up When you can see the 230V label the instrument is set for 230V input If you plug the instrument into an 115V power supply while 230V is selected the instrument will have insufficient operating power To select 115V input insert a straight screwdriver blade or similar instrument into the slot on the switch and slide it into its alternate position Upon slidi
44. having absorbance values higher than the highest calibrator or lower than the lowest calibrator Note that the Off Curve flagging feature requires that the calibrators be entered and read from lowest concentration for calibrator 1 to highest concentration for the final calibrator Set Carrier to X Then Press Enter where X is either 1 or A depending on the strip type Load the first strip into the right most carrier position and press ENTER While the strip is being automatically positioned for reading the display will indicate Positioning Strp After the strip or strips containing the standards are read there will be a pause after the standard curve is read Next the slope and intercept of the linear regression will be printed The correlation coefficient r will also be given as an aid in determining the acceptability of the curve The display will prompt PLOT CURVE Y N To plot the regression line press YES Press NO to continue without printing the curve If calibrators were read in duplicate you may choose to edit the curve The display will prompt DELETE WELLS Y N Use the YES or NO key to answer If you press NO the instrument will proceed to read and calculate the remainder of the strips If you choose to edit the curve by pressing the YES key the display will ask for the location of the well s that are to be deleted Enter the wells one by one You may delete as many as one from each pair but you m
45. he following precautions are offered to further assure quality laboratory results Read your instrument instruction manual before performing patient testing and then keep it handy as a reference Be sure that you fully understand the purpose and limitations of this instrument Use of the bichromatic differential absorbance for instance generally increases precision since the element of variation caused by imperfections in disposable plastic strips is removed from the results In order to preserve sensitivity however it is important to select the correct combination It is also advisable to make dilutions of solutions that exceed 2 0A You must also understand the relationship of read volume to absorbance Use clean strips and follow the instructions for blanking and standardizing very closely Use of the appropriate blanking material is also very important water alone is not always specified Do not read wells with bubbles or condensation ZAwareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 37 PIE e Check your display and printed results during operation Your display and printer provide useful information such as the values you enter the mode of operation you select whether or not you remembered to blank and all absorbance readings Monitoring the printer and display during operation may help you detect an error in the making e Check the calibration and linearity of your instrument against some standard referen
46. inal on the rear panel of the instrument to a suitable ground such as to a grounded pipe or some metal surface to earth ground Observe All Terminal Ratings To avoid fire or shock hazard observe all ratings and markings on the instrument Consult this manual for further ratings information before making connections to the instrument Install as Directed The Microstrip Reader should be installed on a sturdy level surface capable of supporting the instrument s weight of 13 lbs 5 9 kg safely for safety and ventilation purposes The mounting surface should be free of vibrations Provide Proper Ventilation Refer to the installation instructions for details on installing the product so it has proper ventilation The instrument should be surrounded by the following clearances 8 cm around perimeter of unit and 8 cm on top Do Not Operate Without Covers Do not operate this instrument with covers and panels removed 4 Stat Fax 303 Plus Operator s Manual Rev J EAwareness Technology Inc PE PIE Use Proper Fuse Use only the fuse type and rating specified by the manufacturer for this instrument Use ofa fuse with an improper rating may pose a fire hazard Refer to the section on Trouble Shooting for details on fuse replacement Avoid Exposed Circuitry Do not touch exposed connections and components when power is present Avoid Excessive Dust Do not operate in an area with excessive dust Do Not Operate With Suspected Failures If
47. ion about making general selections such as mode filter blank duplicates cutoffs and controls Section 2 2 follows with mode specific instructions for each of the general purpose calculation programs Section 2 3 explains how to create and use your own test menu stored in nonvolatile memory Finally Section 2 4 provides specific details on the operation of additional special features i e clock and calendar lamp saver etc 2 1 General Selections Although many features are available to aid the user this instrument may be operated very simply in most modes by bypassing optional features For every test the instrument will require a mode selection and filter choices Thereafter only those questions that pertain to the calculation mode selected will be asked In the absorbance mode for example there are no further selections required Here is a list of questions to review before beginning a test 1 What strip length will be used 8 wells or 12 wells What strip type will be used e g break apart What calculating program will be used What filters are optimal operating and differential wavelengths Is a blank required Desired What is the calibrator value s Will blanks calibrators and or specimens be read singly or in duplicate O Oe JON a ae I Will locations of 1 or more controls be marked If so you will need to indicate row and strip number for each 9 Will control acceptance criteria be entered for
48. ive and negative controls and to enter control acceptance criteria for automatic comparisons to select positive and negative interpretations based on concentration value and to edit out discrepant duplicates with automatic reread and recalculation Instructions for each of these modes and convenience features are provided in this manual ZAwareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 1 User Programmable Memory User programmable memory allows the operator to store test protocols recall tests by number and delete unwanted tests from a user generated test menu Instructions for using this memory are given in section 2 3 3 Recalling a Test Besides quick accurate and reproducible results the instrument offers maintenance free and easy operation versatility and economy A stable factory calibrated durable design with a timed lamp saving feature further assures the reliability of this instrument 1 2 Principles of Operation Light energy from an overhead lamp is focused by a lens directed through an aperture and then passed vertically through the sample Below the sample a continuously rotating wheel positions the filters so that readings can be taken very quickly at both the primary and differential wavelengths Use of bichromatic differential absorbance values corrects for optical imperfections in the plastic wells differences in well meniscus turbidity and lamp variation A photo detector convert s transmi
49. l filter When reading monochromatically the blank absorbance is elevated relative to the curvature of the meniscus A correction called offset absorbance can be entered by the user to compensate for this effect To determine the correct offset absorbance read a well of your blank material in the absorbance mode monochromatically without blank or offset Determine the difference between the observed and expected value This is your offset absorbance When no differential filter is selected the message OFFSET ABS Y N is displayed If you answer YES you see OFFSET ABS Enter the value that should be subtracted from the observed blank absorbance ZAwareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 35 PIE 36 2 4 5 Calibration and Linearity Every instrument is calibrated during manufacture using standards whose absorbance readings are traceable to the NIST Each instrument is also tested to verify its linearity to 2A No calibration adjustment is accessible to the operator since the pre set calibration is very stable Absolute calibration can not be readily verified without using a specifically designed product called DRI DYE Check Strips available from your instrument supplier This is because in vertical photometry the fill volume and degree of meniscus determine the pathlength and absorbance is proportional to pathlength For lab test results that are based upon standards rather than
50. labeled Equivocal The instrument then asks for the number of each type of control to be read You may select O for of Neg Controls and or Pos Controls but you must choose at least one Cutoff Control The instrument will also ask for the absorbance acceptance criteria for the mean of each type of control For each type of control the instrument asks for the number of each type of control to be read the absorbance acceptance criteria and if the criteria apply to the individual wells or the mean of the wells for that control The display will show Num of NCs Type in the number of Negative Controls and press ENTER The display will show Neg C lt Neg C gt Type in each value and press ENTER If you select 2 or more wells for each control the display will prompt Check mean Y N Press NO if the criteria apply to the individual wells or YES if the criteria apply to the mean of the wells The display will show Num of CCs Type in the number of Cutoff Controls and press ENTER The display will show C O C gt C O C lt Type in each value and press ENTER The display will show Num of PCs Type in the number of Positive Controls and press ENTER The display will show Pos C gt Pos C lt Type in each value and press ENTER The instrument will then prompt Corr Factor Y N This correction factor is multiplied by the mean of the C O Contro
51. lections Whenever Set Carrier is displayed you may press the INTRP key There are three exceptions absorbance mode cutoff mode and cutoff control mode You will see Pos gt in the display Type in the upper cutoff then press the ENTER key Next the instrument will display Neg lt If you do not need a lower cutoff press the ENTER key to bypass this step Otherwise enter the value of the lower cutoff and press ENTER The cutoff s will be printed Check the printout to see that they are correct before proceeding In Point to Point and Multipoint Abs modes you may also choose to flag samples having absorbance values higher than the highest calibrator or lower than the lowest calibrator Stat Fax 303 Plus Operator s Manual Rev J EAwareness Technology Inc PE 2 1 9 Selecting Control Options There are two optional features that facilitate the location and analysis of controls and their results First the locations of up to 3 total positive and negative or high and low controls will be indicated on the printout if programmed by the operator Additionally the operator may enter a control acceptance range for the high control and an upper limit for the low control The instrument will print the control criteria and automatically compare the resulting concentrations of located controls with these limits Control results are flagged on the printout Control locations and acceptance ranges are entered using th
52. ls to result in the actual cutoff value Press NO if you do not want to use a correction factor Press YES and the display will show Corr Factor You may enter a correction factor with up to 3 decimal places The display will show Done Y N Press YES to run the test Press NO to select options for additional quality control values You may chose to check the ratio or the difference between the means of the positive and negative controls to assure adequate distinction The display will show Ratios Y N Press YES to enter the ratio value for mP mN gt Enter the lowest acceptable ratio for the mean of the positive controls to the mean of the negative controls Press NO and the display will show Difference Y N Press YES and the display will show mP mN gt Enter the lowest acceptable difference for the mean of the positive controls minus the mean of the negative controls Many options not required can be bypassed by pressing ENTER Otherwise type each value and press ENTER Once all information has been entered Set Carrier to X Then Press Enter is displayed where X is either 1 or A depending on the strip type Load the first strip into the right most carrier position and press ENTER While the strip is being automatically positioned for reading the display will indicate Positioning Strp ZAwareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 27 PIE You may use the
53. m Melles Griot Optical Guide 3 1985 pp 266 269 2 Other engineering data supplied by Awareness Technology Inc Palm City FL 1987 2006 3 Data on Dri Dye Check Strips provided by Awareness Technology Inc Palm City FL 1988 2006 ZAwareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 41 PIE 42 Notes Stat Fax 303 Plus Operator s Manual Rev J ST EAwareness Technology Inc 4 0 APPENDICES PIE Appendix 1 contains information concerning Dri Dye Check Strips which can be used to verify proper calibration and linearity of your Microstrip Reader instrument Appendix 2 is a sheet which may be used to document your stored menu tests Appendix 3 is a set of sample printouts of data from each calculation mode Some modes have been set up to show various options available in many modes such as control location blank location duplicate options curve plotting and cutoff interpretations Appendix 4 provides contact information in the event the user has questions regarding instrument operation ZAwareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 43 4 1 Appendix 1 Dri Dye Check Strips 44 DYE CHECK STRIPS Dri Dye Check Strips offer an easy means of verifying proper calibration and linearity on a routine basis If a strip reader can obtain acceptable results with this kit then the instrument demonstrates linearity calibration filter integrity r
54. n microstrips up to 12 wells in length as well as break apart wells whether the wells have flat or round bottoms An accessory carrier is available for use with dual column 2x8 well strips and single column 8 well strips The user need only position the carrier to the desired row the instrument automatically positions the strips reads absorbances calculates concentrations and prints results lt comes with a built in thermal graphics printer with the capability to plot standard curves Besides providing absorbance readings this instrument also offers pre programmed modes for performing the most commonly used calculations multiple convenience features and user programmable memory to further facilitate testing Preprogrammed Modes The reader is programmed with many keyboard selectable general purpose programs Each mode is self prompting to reduce error and simplify operation The general purpose programs include absorbance single point calibration cutoff determination multi point linear and log logit regressions and point to point connections multi point absorbance calculations and an uptake mode Each mode is described in detail in section 2 2 Calculation Programs These calculation modes have been selected to facilitate the performance of enzyme immuno assays drug levels and other similar tests Convenience Features Multiple convenience features include automatic blanking options and the ability to indicate the locations of posit
55. nc PE The instrument will read every well at both selected wavelengths reporting the difference of the two absorbance at primary wavelength minus absorbance at differential wavelength Be sure to select a differential wavelength at which your chromophore has little or no absorbance otherwise sensitivity may be lost 2 1 5 Selecting a Blank If the instrument is not blanked the readings are relative to air no well or contents The difference between a water blank and an air blank is typically less than 0 020A when reading bichromatically The Calibrator Single Standard Mode requires that a blank be used in the first well of the first strip The Uptake Mode operates with no blank All of the other modes offer the option of a blank in the first well or no blank at all The material of choice is a reagent blank that best defines the absorbance of zero concentration The absorbance which is printed for a blank well is the absorbance of the blank material relative to air This absorbance value is automatically subtracted from subsequent absorbances before printing and calculating 2 1 6 Selecting Duplicates In most modes you have the option of reading either one well or two consecutive wells of the blank and calibrators When duplicates are chosen the mean absorbance reading is used as the reference absorbance for the blank and calibrator You may also choose to read specimens singly or in duplicate If duplicate sample
56. nce of a single calibrator by its concentration This factor is then divided by each subsequent absorbance to calculate the concentrations of unknown samples No blank may be used and the calibrator must be in the first well Note that this mode will neither print nor store the curve After filter duplicates and unit selections the display prompts CAL1 Type in the calibrator concentration up to 999999 up to two places after the decimal point for CAL1 lt 1000 and press ENTER The display will then prompt Cal Limits Y N Select NO to continue or select YES to enter absorbance limits for the calibrator the display will prompt Cal 1 gt Enter the minimum acceptable absorbance value for the calibrator Set Carrier to X Then Press Enter is displayed where X is either 1 or A depending on the strip type Load the first strip into the right most carrier position and press ENTER While the strip is being automatically positioned for reading the display will indicate Positioning Strp The instrument will be ready for the next strip when it displays Set Carrier Then Press Enter To continue reading in the Uptake mode load the next strip and press the ENTER key Press CLEAR twice to cancel the mode 2 3 User Test Menu This instrument offers the operator 8K bytes of non volatile memory This is user programmable memory enough for about 31 tests that will not be lost when the instrument is
57. ner s Manual and a serial cable NOTE Retain the original packing material for future use in the event that the instrument is shipped to another location or returned for service Instrument Mounting and Use Place the instrument on a flat working surface capable of safely supporting the weight of the instrument approx 21 Ibs 9 5 kg Excessive vibration during reading may cause poor repeatability thus a sturdy working surface is required A clearance of at least 3 inches 8cm around the instrument is required to assure optimal ventilation It is recommended that the instrument be operated within an ambient temperature range of 18 35 C and humidity of less than 80 Power Switch Position When installing the power cord or if changing the setting on the voltage select switch the unit should be turned off Look at the rear panel of the instrument to check that the power switch is in the Off position Power Cord Requirements Use only the power cord specified for this product and certified for the country of use For 110 120 V units used inside the US use a UL listed cord set consisting of a minimum 18 AWG Type SVT or SJT three conductor cord maximum 3 meters 10 feet in length rated 10 A 125 V with a parallel blade grounding type attachment plug For 220 240 V units used inside the US use a UL listed cord as above except rated 250 V with a tandem blade grounding type attachment plug The cord set provided by the manufacturer me
58. ng the switch you will see the 115V label appear E EEN If the instrument is configured to accept 115V and you plug it into a 230V power supply the fuses will blow and permanent damage to the electronics may result Assure Clean Power Availability The circuit used should be substantially free of large voltage transients Kilovolt amp loads such as large pumps large centrifuges refrigerators and freezers air conditioners large autoclaves ovens and dryers The instrument may fail to operate normally if the power supply is interrupted If this occurs turn the instrument off fora moment When you turn the instrument back on it will resume normal operation but a standard curve which was not stored in nonvolatile memory will be lost Fuse Requirements The fuses are located internally in the instrument there are two fuses fusing both sides of the main power supply Fuse failure is a very rare occurrence and should indicate malfunction of the equipment requiring service by qualified personnel The fuses used within this instrument are 1 2 Amp T rated slow blow 250 V Cartridge size is 3AG or size 0 dimensions 1 4 x 1 1 4 6 3 x 32 mm For continued protection against risk of fire use the same fuse for either 115 or 230 V line voltage selection Disconnect power cord from mains supply before replacing fuses 1 5 2 Serial Port The serial port on the back of the instrument echoes the data shown on the internal printer except
59. no unit label are provided for labeling the concentration column 0 Conc 8 EV 1 AU mL 9 U mL 2 Ratio 10 A mL 3 IU mL 11 ppm 4 ulU mL 12 ppb 5 CAL 13 Abs 6 GPL mL 14 Index 7 MPL mL 15 When the display prompts Select Units Y N select YES to choose a unit designation The display will then prompt Key unit code To print the list of units press 9 9 ENTER To choose a unit of measurement select the numerical designation and press ENTER The selected unit will be displayed along with Y N If the displayed unit is correct press YES If the unit selected is incorrect press NO to return to the previous prompt If no unit labeling is desired select 15 ENTER 2 1 8 Selecting Cutoff Interpretations Samples may be labeled as Positive Equivocal or Negative according to operator entered criteria The criteria used are either a single upper cutoff or both an upper and lower cutoff When a single upper cutoff is used any concentration which is equal to or greater than the cutoff will be labeled as positive The letters P and N are shown in the right most column of the printout to designate these interpretations If an upper and a lower cutoff are both used then the concentrations which are greater than or equal to the upper cutoff are still labeled as positive but only concentrations less than the lower cutoff are labeled as negative All other concentrations are labeled E for equivocal To make cutoff se
60. nsibility to assess any implications Error messages appear on the display when the instrument fails to continue to operate These messages help the operator locate the cause of the problem since it must be overcome before proceeding The Microstrip Reader employs these flags and error messages 53 00 is reported in the absorbance field if a reading exceeds 3A gt 10 6 is printed as the concentration value whenever the calculated result is greater than 6 digits and can not be properly printed in the concentration field CONTROLS FULL is displayed if a fourth control location is attempted 34 Stat Fax 303 Plus Operator s Manual Rev J EAwareness Technology Inc PE Off Curve is printed when a sample value is greater than the highest calibrator or less than the lowest calibrator PRINTER JAM is displayed when the internal printer paper path is obstructed It must be cleared before printing can resume To avoid this problem never feed paper backwards and never load paper with a rough cut edge Mechanism Error and TEST ENDED are both displayed and printed when the strip can not be transported properly This usually indicates improper strip loading obstruction or a mechanical failure Use only standard size microstrips and microwells and ensure they are seated firmly in the carrier Lamp filter s low is printed when less light than necessary is detected which may indicate that the lamp
61. o 12 wells in about 30 seconds DISPIAYs aieiai T T A LCD 16 characters 5x7 dot matrix Internal Printer cc ccccsecceeeeeeeeeeeeaeees Thermal dot matrix 20 characters per line Keyboard ee 16 key membrane switch 4X4 Calculation Modes ooooooococccccccncccnancccnoninons Single point calibration Multi point calibration with regression or point to point curve fit cutoff cutoff control Absorbance Multi Point Uptake Serial Rot et ccc gege ENEE eaves Output only 2400 Baud 1 start bit 8 data 1 stop no parity no handshake Power SOUICE cooooocccoccnnccnnccnnncnnnnnnnnonnnonnnnnos Switch selectable power supply 115V or 230V indicated Voltage Source 110 120 220 240 VAC from 50 to 60 Hz CAT Il Power consumption is less than 50 Watts Fuse two 1 2A T rating 250V 3AG type fuse All power cords must be approved for the country of use Certifications and Compliances NRTL Listed Standard UL 61010A 1 Electrical Equipment for Laboratory Use CE Certificate of Conformity Conforms to the following standards EN 61010 1 EN 61326 following the provisions of the 98 79 EC IVD directive Physical EplOeUte eege ene Eege ABS Plastic cover with metal base DIMENSIONS rra rr Approx 9 x 12 x 3 23 x 30 x 8 cm 13 Ibs 5 9 Kg 12 Stat Fax 303 Plus Operator s Manual Rev J SS wareness Technology Inc PIE Environmental Conditions for Safe Operation Indoor use Altitude up to 2000m Temperature 5
62. o load and could cause a paper jam Feed a clean cut edge of the paper from the back into the printer along the top edge of the metal guide inside the printer paper well Feed slightly more than 1 inch 3 cm of paper in then press the PAPER key several times to automatically feed the paper through the printer You will see the paper feed up through the paper slot in front If you have difficulty cut a new straight edge before trying again Drop the roll of paper into the printer paper well in back spooling up any loose paper Replace the paper cover by pinching its sides together and placing it down over the roll of paper Use of the paper cover is optional for holding the paper down into the printer paper well 1 5 4 Check out Procedure After installation and each time you start up the instrument perform the following instrument checkout procedure If any portion of the procedure does not check out properly contact your dealer to arrange for assistance Turn the power switch on The printer should print the instrument name and X where X is the software revision level Then the time and date will print If they are not correct see section 2 4 1 Clock and Calendar for setting time and date Look for Ready and the correct time in the display Press the ABS key Look into the strip track for light indicating that the lamp is lit See ABSORBANCE MODE displayed and printed The instrument will then display SELECT FILTER S
63. or run a new one NOTE Since many assays require re running calibrators you must ensure that curve storage is appropriate for your assay If using a stored curve is inappropriate you should re run your calibrators upon test recall by selecting NO when STORED CURVE Y N is prompted ZAwareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 33 PIE 2 4 Special Features 2 4 1 Clock and Calendar To set the correct time and date use the ALT key to access the command for setting the clock When you press ALT you will first see SAVE TEST Y N Press NO Then you will see STRIP TYPE Y N Again press the NO key Now you will see DELETE TEST Y N Answer NO Then you will see SET CLOCK Y N This time press the YES key Depending upon the selected date format the display will ask for the month the day and the year last 2 digits by displaying Date MM DD YY or the day month and year by displaying DD MM YY Use two digits for each entry and separate the entries using the decimal point key When the proper date is displayed press ENTER The instrument will then display Time HH MM SS asking you to enter the hour 1 24 minutes and seconds Again use two digits for each entry and separate your entries using the decimal point key When entering hour use 13 for 1PM 14 for 2PM etc Press ENTER when the displayed time is correct You may configure the reader to display the d
64. r calibrators Type in the upper limit and press ENTER Then the instrument will display HC Lo lt Type in the lower limit and press ENTER The instrument will then display CONTROLS Hl 1 LO 0 again A total of three controls all high all low or some of each may be located All high controls will be compared to the range you entered for the first high control For low controls there is only an upper limit The message LC HI gt will be displayed to prompt for the value above which the low control will be considered too high When you have finished entering controls press ENTER again to return to the Set Carrier prompt If control locations are entered for wells that have been reserved for either the blank or calibrators then the blank and calibrator indicators will override positive and negative control indicators when the sample identifications are printed H L or no flag are used to indicate high low or in range respectively If your test is stored the locations and acceptance criteria of the controls entered will also be stored for later recall ZAwareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 21 PIE 22 2 1 10 Selecting an END location If you wish to read partial strips you may use the END key to return the strip to home without reading an entire strip When the display shows Set Carrier press the END key and enter the number of total wells you wish to re
65. s are selected the mean absorbance reading will be used to calculate the result for the pair The reported results for each sample are based on a single concentration value To make selections use the YES and NO keys to answer questions when they are displayed If you select YES to the prompt Duplicates Y N the display will show the following prompts Dup Blanks Y N Dup Calbrtr Y N and Dup Samples Y N You may choose duplicates in any combination When you have made all the selections for duplicates select YES when the display shows Done Y N and your selections will be printed Duplicates must be pipetted into consecutive wells Controls are read in duplicate only if the samples are selected in duplicate When using the controls locator feature only label one location of the control duplicate pair See section 2 1 9 for more information about the controls locator feature When using multi point modes the absorbances of duplicates will be averaged to designate a single point For example consider a 3 point linear regression for which the 3 calibrators are read in duplicate For calculating the standard curve n 3 n 6 If one well of a pair is deleted during an editing cycle then the other well will represent the mean point and n 3 n 2 and n 5 ZAwareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 19 PIE 2 1 7 Unit Codes 16 units of measurement designations plus a blank selection
66. se are used to calculate the concentrations of unknown samples according to Beer s Law The resulting calibrator curve is a series of line segments connecting the calibrator points which is similar to the point to point mode In addition the calibrator with the highest absorbance A calibrator is assigned a value of 100 and all samples have an additional reported value of 100 sample Abs A Cal Abs Unknown samples are calculated as in the point to point mode see section 2 2 6 The additional A A calculation is made as above and printed on a second sample data line Note The calibrators absorbances must be decreasing down the strip i e the first calibrator is the darkest the second must be the next darkest etc The plotted curve shows absorbance vs A A Note If you are using a stored curve you must still run the A calibrator to recalibrate the stored curve All samples will be calculated using the stored A A values for the curve and the newly run A calibrator absorbance Except for the differences mentioned above please follow the procedures for running the Point to Point mode to proceed in this mode ZAwareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 31 PIE 2 2 8 Uptake Mode The Uptake mode UPT is a modified Calibrator mode often required for uptake assays Be careful to use your cutoff options correctly in this mode In this mode a factor is calculated by multiplying the absorba
67. t most carrier position and press ENTER While the strip is being automatically positioned for reading the display will indicate Positioning Strp The instrument reads the strip and prints the results Four columns are printed Well tells which well the reading is from Abs prints the absorbance reading Index prints the ratio of the sample to the positive interpretation cutoff I prints sample interpretations N indicates a negative reading P indicates a positive reading or E indicates an equivocal reading Error messages will also print in the Interpretation column H indicates that the blank or the individual control exceeded the limit entered L indicates that the individual control was lower than the limit entered ZAwareness Technology Inc Stat Fax 303 Plus Operator s Manual Rev J 25 PIE After the first strip is read and the test is valid the display will prompt C O Abs OK Y N If the cutoff value is acceptable press YES If the cutoff value is not acceptable press NO If the test is stored the display will prompt Recall Test Y N If the test is not stored the display will prompt Re Start Y N In either case press YES to run the test again press NO to return to C O Abs OK Y N or press the CLEAR key twice to cancel the mode If the test is invalid for any reason Test is invalid will be printed after the control readings and only the absorbance
68. t require the first strip to be in the right most carrier position The instrument reads the strip and simultaneously displays and prints the results If blanking was selected the letter B will appear beside the first well number When the instrument is ready for the next strip the display will indicate Set Carrier Then Press Enter To continue reading in the Absorbance mode position the carrier for the next strip and press the ENTER key Since there are no concentration interpretations in absorbance mode the cutoff and control options are not available Press the CLEAR key twice to cancel the mode 2 2 2 Calibrator Single Standard Mode In this mode a single calibrator material of known concentration is used to calculate concentrations of unknown samples according to Beer s Law Well A 1 the first well of the right most carrier position is always considered to be the blank with the calibrator well s immediately following If the duplicate blank option is selected the first two wells contain the blank material After the filter duplicates and unit options the instrument will display Cal 1 Type the concentration value assigned to your calibrator material then press the ENTER key The printer will print Cal 1 XXXX where XXXX is the calibrator value you have entered Note that the instrument allows calibrator values up to 999999 and calibrators less than 1000 can have up to two places after the de
69. tet co MMI Ke RTE O e 1 ot wo Mt E se ON min min nu J kel fe DOM AMANO S vi ma 2 0 a oo 1 t D as es D gt HYDD TTI at ax I xI a Ki D DD Crates En 5 co wt o v o Ke ONOLO 202 of SANA ol e w e o Zu QLN OC ano EI gt lt THOS li NO IND IDO ra e DU en 5 a eN e six eM ee od e WMO N n M ADe M MOnt D po eg eer et Omt COMM Mm GR en OTON E pe OZ a 101 Ln pp w gf ANDOM eat ee H uu Tui na Snilli I se UN sanau 2 D my BYAR Sec ie EAE LSS NGOS NN Dee 3 ONO ar A H O es OQUO s ell i D se Y vn m ss QU Cc P ary OO oo ZI 1 aa At EES Y 4 Debt UD O Dore e DO e A SL en o noz YO gt Gecke o Nest pi L Di e D ES SGM i Lea Li o o 00 L ai ke ke gt Cl Sieg OO 2 00 0 22323 OO Op 1 AI z oOo aN 2 Os Souwma2zrszzzg eFoaVF S MOTA SOLL EL SOLDEN Fett AED AC dir ak 00 E NN mi Mm OA ao Me abe ZZ Nn e 1 E com es MI LI WW n ut i E mt HANU NOW int nO Mim BHO LD Al wv 8 ee 8 2 eee tegt lt x ID am TIXI E AO CAPA DO Iau o o o Ze mees O eet en w en LINA Oe N DIE D 7 EY ESOO INMI al o en E eee MU el el VOOM Mt wero NDMC o gt gt ECHO DOOM oono o PND 11 GOOD Y tren OZ D 1411 AAA SN nn LINDO ANO Lian Les H H LEI H sa UN N asss ps e Ko DZNZ nv H Secci Lienen Dee LOA ADD 5 Net a ei ODO e OU e OI VO Ou a E Load Lo KANAL y TAIDO ni oo Ka sf elei im LOZA OA gt gt Net m VUNMEVEOI 1 Le S OO o n NOHO I OO 2 ILIV sie D m5 bar SOLOMMx gt L
70. tion Use only the specified paper available from your dealer Problem The normal operation of the instrument is suddenly interrupted Solution As with all microprocessor controlled devices fluctuations and interruptions of the power supply may cause the Microstrip Reader to fail The keys may not respond to touch and the display may remain fixed Turn the power switch off and wait for about 5 seconds Then turn it back on The instrument will start up normally If this interruption to normal operation occurs with frequency you should try plugging your instrument into a different circuit Choose a circuit that is free of large transient voltages such as pumps refrigerators etc If this is not possible install a commercially available surge protector or noise filter Problem The external printer fails to print Solution Once you are certain that it is turned on consult the printer manual for the correct dip switch settings Refer to sections 1 5 3 of this manual for more information about printer requirements If only one setting is wrong the printer will either print nonsense characters or nothing at all Support is available to help you solve any technical problem or question with this instrument Please call fax or write your dealer for immediate attention Stat Fax 303 Plus Operator s Manual Rev J EAwareness Technology Inc PE 3 5 References 1 Interference filter temperature and humidity recommendations adapted fro
71. tion signs gt and lt are reversed in this mode The regular Cutoff Mode is described below followed by notes on the Reverse Cutoff Mode In addition the Blank is not subtracted in the reverse cutoff option The following description is for the normal cutoff mode The instrument will then prompt BLANK Y N If you press yes the instrument will display Blank lt The reader will use this value to check that the blank is valid Type the greatest acceptable absorbance value for the blank material relative to air and then press ENTER The blank absorbance will be subtracted from all subsequent wells and will be flagged if it exceeds the set limit The instrument now prompts for the X Y and Factor values Type each of these values followed by the ENTER key If Y 0 and Factor 0 the display will prompt Min C O Y N Press YES if your test has a minimum cutoff value If X mNC is less than the Min C O the Min C O will be used as the cutoff The display will prompt Min C O Enter the minimum cutoff value Stat Fax 303 Plus Operator s Manual Rev J EAwareness Technology Inc PE After these values are entered into the equation the instrument prompts Equiv Range Y N If you answer YES you will be able to enter an equivocal range based on factors of the cutoff value The instrument will prompt Neg lt X COV X Enter a number which when multiplied by the cutoff value will be the upper limit of the
72. trument will display Get Carrier Press the CLEAR key twice to cancel the Check Out See Ready and the time in the display If you do not wish to perform the Check Out turn the instrument on and see Ready and the time in the display The lamp will warm up for 45 seconds During this time you may begin making your selections If the lamp warm up is not completed by the time you press the ENTER key to read the first strip the display will indicate LAMP WARM UP 00 where 00 represents the number of seconds remaining When the instrument is ready a double beep will be heard and the instrument will begin reading GENERAL OPERATION TIPS e Wipe any dust or fingerprints from the bottoms of the strips before using Do not read strips that contain bubbles or condensation Use the same volume for the blank as you use for the samples 2 1 1 Selecting a Strip Format Microstrips are typically either 8 or 12 wells in length Using the keyboard this instrument can be configured for reading and labeling either type of strip When using the standard 12 well carrier you may still select either strip format First press the ALT key ALT stands for alternate functions You can use this key to access several functions including changing the strip type The first display is SAVE TEST Y N Respond by pressing the NO key Next you will see STRIP TYPE Y N This time answer with the YES key The display will ask 8 WELLS Y
73. tted light energy into electrical signals which are amplified and interpreted EAwareness Technology Inc PE 2 Stat Fax 303 Plus Operator s Manual Rev J 1 3 Warning Markings PIE 1 3 1 Safety Symbols Safety symbols which may appear on the product A A 3 WARNING Protective Ground CAUTION BIOHAZARD Risk of Shock Earth Terminal Refer To Manual Risk of infection FUSE For continued protection against the risk of fire replace only with fuse of the specified type and current ratings Disconnect equipment from supply before replacing fuse 1 3 2 Safety Terms These terms may appear on the product DANGER indicates an injury immediately accessible as you read the marking WARNING indicates an injury hazard not immediately accessible as you read this marking CAUTION indicates a hazard to property including the product Terms which may appear in this manual AN statements identify conditions or practices that could result in injury or loss of life WARNING indicates an injury hazard not immediately accessible as you read the marking Aisa statements identify conditions or practices that could result in damage to this product or other property BIOHAZARD Biohazards are biological agents that can cause disease in humans Lab workers handling potentially infectious materials must use universal precautions to reduce the risk of exposure to these agents ZAwareness Technology Inc Stat Fax 303 Plus Operator s M
74. upon absolute absorbances the linearity of the instrument is the more critical indicator of instrument performance A gradual reduction in linearity is indicative of filter degradation If this occurs filter replacement will be required for continued reliable operation A monthly verification of instrument calibration and linearity is recommended Such monitoring can be done using DRI DYE Check Strips There is more information about DRI DYE Check Strips in the Appendix Stat Fax 303 Plus Operator s Manual Rev J EAwareness Technology Inc PE 3 0 ADDITIONAL TIPS AND INFORMATION 3 1 Restoring Electronic Calibration This instrument allows the entry of permanent calibration data by keyboard This data is entered at the factory as the original calibration data and is maintained in the non volatile RAM of the instrument The data is also printed on the CALIBRATION DATA label affixed to the bottom of the unit DO NOT ALTER ANY POTENTIOMETER SETTING SUCH ALTERATION RENDERS THE FACTORY CALIBRATION DATA INVALID If the calibration data is lost the printout will show the message DO ABS SET TEST 212 If the data is not restored the message will continue to be printed each time the unit is turned on and every time a new mode is selected or ended The mode will operate but calibration must be restored to assure accuracy If the date is lost reenter the date and time before restoring the calibration data Then enter the data from the
75. ying of Cals The number of calibrators must be less than or equal to eight seven with a blank The display then prompts for unit selection Stat Fax 303 Plus Operator s Manual Rev J EAwareness Technology Inc PE The instrument will then prompt you to enter the calibrator values As you enter the values the printer will print CAL 1 XXXX CAL 2 XXXX CAL 3 XXXX where XXXX represents the calibrator values you entered Except for the log logit mode which requires increasing calibrator values and decreasing calibrator absorbance the points may be entered in any order but must be read in that same order for accurate pairing The regression line may be used for both positive and negative slopes The number of standards must be less than or equal to eight seven with a blank NOTE When using a format which calculates the In of the concentration do not use 0 0 for the concentration since In 0 is not defined Likewise when using In of 1000 Abs the absorbance values must be non zero and positive Note that the instrument allows calibrator values up to 999999 and calibrators less than 1000 can have up to two places after the decimal point Decimal places for the reported concentrations will be the same as those selected for calibrator 1 After all the calibrator values have been entered the display will prompt Off Curve Ok Y N Press YES if all samples are valid Press NO to flag all samples

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