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Stat Fax® 2100 Operator`s Manual

1. 39 2 3 9 SSE MENU k SEE 39 2 3 6 Multi Test Format AUX1 kk nennen nnns 39 2 4 opeclal Features gee Eege k ee EU EUR 42 241 TION P 42 2212 PIR qe 42 c ge 42 2 4 4 Lamp Saver Feature usu reels eluting k s kaka acne icri kaka a wa kek keka aa ERE 43 2 4 5 Flags and Error Messages 43 2 4 6 Calibration and bine EE 44 2 4 7 Clock and Calendar Ek kk kk kk KK KAK 44 2 4 8 Mechanical Col NE 45 2 4 9 Monochromatic and Offset Absorbance 45 3 ADDITIONAL TIPS AND INFORMATION cccccceeeeeeseeeseeeeeeeeeeeeeeeeeeeeeeeeees 47 SES Precautions NE Me bAn na ceed WENA K Ke 47 EE le 47 33 Jee eech 48 94 Re l l gt mr ee ne ne ura ua eet dee Eva Ke eee ee 50 3 9 Dm Dye CIHOON e 50 3 6 Sample IP PS ceca nele illa lS k laya ek naa w k ak a E asa KCR KEK ken R 51 oF Wiser TESt ISM N ere PR N o o rrr td 59 3 8 Contact Informati9on u Tu aaa sassa sasa asa aa saa sassa sasa sasa aasan sss 60 1 INTRODUCTION 1 1 Applications 1 1 1 Intended Use The Stat Fax 2100 is a laboratory instrument intended for in vitro diagnostic use It is a compact microprocessor controlled photometer system designed to read and calculate t
2. Approx 43 x 37 x 18 cm 11 4 kg Environmental Conditions for Safe Operation Indoor use Altitude up to 2000m Temperature 5 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 temperatures up to 31 C decreasing linearly 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 8096 Optional Accessories Serial printer DRI DYE Check Strips for instrument QC 2 OPERATING PROCEDURES To begin the reader 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 General Selections provides information about making general selections such as mode filter blank replicates cutoffs and controls Section 2 2 Calculation Programs follows with mode specific instructions for ea
3. When the instrument is ready a double beep will be heard and the instrument will read Standard microplates can be read in either the left right direction 8 well strips or in the front back direction 12 well strips beginning at well A 1 It may be necessary to switch formats in order to perform assays from different manufacturers Your plate reader can be configured for reading and presenting data using either format Once a format is selected it stays selected until you change it or until a stored test of different format is run To select a plate format first press the 8X12 key H key The display will ask READ MODE A to H Y N If you answer YES 1 key the plate will read in the left right direction 8 well strips and data will be printed as A 1 B 1 C 1 etc If you answer NO 0 key to this display the plate will be read in the front back format 12 well strips and data will be printed as A 1 A 2 A 3 etc After you make your format selection your choice will be printed and the display will return to SELECT MODE You may change formats as needed whenever SELECT MODE is being displayed If you store a test in the menu the read direction is also saved 2 1 2 Selecting a Mode Stat Fax 2100 contains several pre programmed general purpose calculations which have been selected to facilitate data handling for enzyme immunoassays and other similar tests 1 Absorbance only ABS key Single calibrator STND ke
4. 0 3174 4 D 2584 0 2194 i 3 0 1704 E 2 122 2 0 9734 0 024 1 ss sd mn nnn CSS SC nn nn en ZC nnn nnn tn nnn een nent CONC Oc 4 2 8 4 12 6 16 8 Y ABSj A X 2 B X C A 1000 1 282 B 0 048 C 0 01 MAX ABS ON CURVE 0 473 MAX CONC 18 80 END OF RUN TEST ENDED 16 09 16 INDEX O CH CO 9 OO OO OH 00 00 ugs 55 22 57 00 63 34 00 DREI PAGE 1 EXP DATE A mL A mL A mL ABS 031 186 178 0 182 409 432 0 420 689 792 0 740 273 005 398 150 115 124 223 418 008 02 SLOPE REGRESSION MODE LOT NUMBER WAVELENGTHS 492NM 630NM AXES SETUP Y ABS X CONC BLANK MUST BE WELL 1 CALIBRTRj41 2 20 0 CALIBRTR 2 40 0 CALIBRTR 3 80 0 DUPLICATE CALIBRTRS Positive gt 50 0 Negative lt 50 0 Last Well is at l1H 02 PLTE WELL SAMPLE ID 1A 1 Blank 18 1 CALIBRATOR 1 0 1C 1 CALIBRATOR 1 0 1D 1 CALIBRATOR 2 0 LE 1 CALIBRATOR 2 0 lF 1 CALIBRATOR 3 0 lG 1 CALIBRATOR 3 0 1H 11 0 1A 2 2 lB 2 3 ic 2 4 0 iD 2 5 0 1E 2 6 0 1F 2 7 ic 2 8 0 1H 2 9 ABSORBANCE 0 739 D 6614 583 505 427 D 350 O 272 D 0 134 k s 1 0 116 SS Q 039 0 00 21 R 0 994 0 TEST ENDED 03 09 98 16 12 40 USER A mL INTERPRET INDEX 0 0 20 0 20 0 40 0 40 0 80 0 80 0 27 5 Negative 0 55 0 0 Negative 0 00 41 2 Negative 0 82 14 0 Negative 0 28 10 2 Negative 0 20 11 2 Negative 0 22
5. 3 0 EV CALIBRTR 2 200 EV CALIBRTR 3 1 0 EV CALIBRTR 4 0 1 EV DUPLICATE SAMPLES Positive gt Ls Negative lt 0 8 Lo Pos Well is at 1F 01 Lo Pos must be 2 4 EV Lo Pos must be gt 1 H EV Last Well is at 1H 02 PLTE WELL SAMPLE ID ABS EV INTERPRET A Hi Cal 1A 1 Blank 0 079 0 0 1B 1 CALIBRATOR 1 1 870 3 0 100 0 1C 1 CALIBRATOR xe 1 091 2 0 58 3 1D 1 CALIBRATOR _ 3 0 502 1 0 26 8 1E 1 CALIBRATOR 4 0 171 0 1 9 1 1F 1 1 183 1G 1 Lo Pos Ctrl 0 880 32 1 9 55d 1H 1 0 267 14 2 1 0 211 239 0 2 Negative 12 7 1B 2 0 325 Ic 2 2 0 367 346 0 5 Negative 18 5 ip 2 1 636 1E 2 3 1 198 117 2 0 Positive 59 7 1F 2 0 580 1G 2 4 0 916 748 1 4 Equivocal 40 0 lH 2 0 821 A Hi Cal de ue 89 2504 38 1507 68 2507 57 750 47 2504 36 1504 26 2504 15 7504 5 25D 4 bon np ow r nnn nnn nnd CONC DG op DT 155 ER Hal END OF RUN TEST ENDED 15 58 09 INDEX 05 08 16 32 16 81 POINT TO POINT MODE 8 PAGE 03 09 98 16 01 20 LOT NUMBER EXP DATE USER WAVELENGTHS 450NM 630NM BLANK MUST BE WELL 1 CALIBRTR 1 2 0 Cone CALIBRTR 2 2 8 Cone CALIBRTR 3 4 0 Cone CALIBRTR 4 5 6 Cone CALIBRTR 5S 8 0 Cone Positive gt 4 0 Negative lt 2 8 Last Well is at l1H 02 PLTE WELL SAMPLE ID ABS Conc INTERPRET INDEX 1A 1 Blank 0 020 0 0 1B 1 CALIBRATOR de 0 130 2 0 1C 1 CALIBRATOR _ 2 0 254 2 8 1D 1 CALIBRATOR
6. A 96 well plate can be read and printed in the absorbance mode in about 2 minutes 1 2 Warning Markings 1 2 1 Safety Symbols Safety symbols which may appear on the product A A A gt 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 2 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 WARNING Warning 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 CAUTION Caution 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 1 3 Safety Precautions To assure operator safety and prolong the life of your instrument carefully
7. KEY 6 z type in the wavelength for the filter in position 2 on the filter label list ENTER 2 4 6 Calibration and Linearity Every instrument is calibrated during manufacturing using standards that are traceable to NIST and each instrument is tested to verify its linearity No calibration adjustment is accessible to the operator since the preset calibration is very stable Absolute calibration cannot be readily verified without using a specifically designed product called DRI DYE9 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 Since lab test results are typically based upon standards rather than upon absolute absorbances the linearity of the instrument is the more critical indicator of instrument performance A reduction in linearity may be indicative of filter deterioration In this event filter replacement is required for continued reliable operation A monthly verification of instrument linearity is generally required to comply with regulatory agencies DRI DYE Check Strips can also be used to verify linearity Alternately the degree of linearity can be checked by reading a 1 2 serial dilution of a material having a peak absorbance at or near one of the wavelengths and observing a 1 2 ratio in the absorbance readings If you prepare dilutions to verify linearity uniform pipett
8. The instrument will display LOAD NEXT PLATE READ To continue reading in the Regression Mode load the next plate and press the READ key Only the first plate must contain the calibrator materials In the event that the absorbance reading of a calibrator is greater than 3 0 A the printer will indicate gt 3 00 in the absorbance field The test mode will not be cancelled If a sample has an absorbance reading greater than 3 0 the printer will also print gt 3 00 for the absorbance reading and will calculate and print the result In the log logit mode any sample with an absorbance greater than that of the reference well will be flagged as gt Reference Note that in the logarithmic modes any values which would require the log of a zero or negative number are invalid and will either invalidate the curve if in the standards or invalidate the specimen Press the STOP key any time after the test has begun to read the second strip third strip in the A H direction if you want to stop the reading without quitting the mode If you want to store this test in your user test menu be sure to store it prior to canceling see section 2 3 f Storing a Test Press the CLEAR key twice to cancel the mode and return the plate to the home position 2 3 Test Menu The Stat Fax 2100 offers the operator 8K bytes of non volatile memory This is user programmable memory enough for 36 tests that will not be lost when the i
9. 09 98 15 36 43 LOT NUMBER EXP DATE USER WAVELENGTHS 492NM 6 amp 30NM BLANK MUST BE WELL 1 CALIBRTR 1 50 0 MPL mL Positive gt 40 9 Negative lt 20 0 Pos C Well is at 1F O1 Pos C must be lt 100 0 MPL mL Pos C must be gt 40 0 MPL mL Neg C Well is at lG 01 Neg C must be 20 0 MPL mL SAVED AS USER TEST 1 37 UNUSED Last Well is at l1H 02 PLTE WELL SAMPLE ID ABS MPL mL INTERPRET INDEX 1a 1 Blank 0 033 0 0 1B 1 CALIBRATOR i 0 584 50 0 1 25 1c 1 1 0 520 44 5 Positive Lll 1D 12 0 526 45 0 Positive Pal 1E 1 3 0 514 44 0 Positive 1 10 1F 1 Pos Control _ 0 765 65 5 1 63 1c 1 Neg Control 0 007 0 6 0 01 1H 1 4 0 271 23 2 Equivocal 0 58 1A 2 5 0 004 0 3 Negative 0 00 1B 2 6 0 404 34 6 Equivocal 0 86 IC 2 7 0 148 12 6 Negative 0 31 1D 2 8 0 071 6 0 Negative 0 15 1E 2 9 0 123 10 5 Negative 0 26 lF 2 10 0 224 19 1 Negative 0 47 1G 2 il 0 120 10 3 Negative 0 25 1H 2 12 0 006 0 5 Negative 6 01 END OF RUN TEST ENDED COV X mNC mPC FAC 8 PAGE 03 09 98 15 43 00 LOT NUMBER EXP DATE USER WAVELENGTHS 492NM 630NM BLANK MUST BE WELL 1 Blank must be lt 0 100 CCV 1 00 mNC 0 500 mPC 0 100 POS gt 1 25COV NEG D 75COV of Neg Controls 2 Neg C must be lt 0 500 of Pos Controls z Pos C must be gt 0 500 mP mN must be gt 1 500 Last Well is at 1H 02 PLTE WELL SAMPLE ID ABS Abs COV INTERPRET 1A 1 Blank 0 033 1A 1 1B 1 Neg Control 0 181 1B 1 1
10. 3 0 403 4 0 1E 1 CALIBRATOR 4 0 600 5 6 lF 1 CALIBRATOR _ 5 0 792 8 0 2 00 1G 1 1 0 811 8 2 Positive 2 05 1H 1 2 0 192 2 4 Negative 0 60 1A 2 3 0 306 3 2 Equivocal 0 80 1B 2 4 0 138 2 0 Negative 0 51 L m 2 5 0 319 3 3 Equivocal 0 83 1D 2 6 0 838 8 5 Positive 2 14 1E 2 7 0 344 3 5 Equivocal 0 88 1F 2 8 0 207 2 5 Negative 0 62 1 2 9 0 695 6 7 Positive 1 69 1H 2 10 0 394 3 9 Equivocal 0 88 ABSORBANCE 0 7904 0 707 0 6244 0 5414 0 4574 9 3744 ss 0 3914 2 O 208 0 2244 1 0 0424 Ee ipii isis kaka dee en necem Pies oe Zu CONC 0 09 2 4 2 E END OF RUN TEST ENDED POLYNOMIAL MODE 8 PAGE 1 03 09 98 LOT NUMBER EXP DATE USER WAVELENGTHS 492NM 630NM CALIBRTR 1 0 0 Cone CALIBRTR42 2 0 Conc CALIBRTR43 4 0 Cone CALIBRTR 4 8 0 Conc CALIBRTR 5 16 0 Cone Positiva gt 10 0 Negative lt 6 0 Last Well is at 1H 02 PLTE WELL SAMPLE ID ABS Conc INTERPRET 1A 1 CALIBRATOR _ 1 0 014 0 0 18 1 CALIBRATOR 2 0 112 2 9 ic 1 CALIBRATOR aoe 0 204 4 0 iD 1 CALIBRATOR 2 0 313 8 0 1E 1 CALIBRATOR 5 0 464 16 0 1F 1 i 0 604 OFF 0 0 Negative 1G 12 0 626 OFF 0 0 Negative 1H 1 3 0 162 3 2 Negative 1A 2 4 0 246 5 5 Negative 1B 2 5 0 119 2 2 Negative ic 2 6 0 255 5 7 Negative ib 2 7 0 632 OFF 0 0 Negative 1E 2 8 0 274 6 3 Equivocal 15 2 9 0 171 3 4 Negative lG 2 10 0 526 OFF 0 0 Negative IH 2 11 6 311 7 5 Equivocal ABSORBANCE OFF CURVE 0 4634 5 0 4144 0 365
11. Cutoff Ctrl or Pos Control The mNC must be less than the mCC and the mCC must have an absorbance greater than 0 000 otherwise the test will be invalid and interpretations will not be reported Press the STOP key any time after the test has begun to read the second strip third strip in the A H direction if you want to stop the reading without quitting the mode 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 DO NOT store a test after an invalid test run as this test will not recall properly Press the CLEAR key twice to cancel the mode and return the plate to the home position 2 2 4 Absorbance Multi Point Mode ABS The Absorbance Multi Point Mode is a multi point calibrator mode that allows the operator to enter as many as seven different calibrator concentrations When you select the ABS key the printer prints ABSORBANCE MULTI PT 8 or 12 for the plate format PAGE 1 indicating the page number of the test the date and the time Spaces will be provided to write in the lot number expiration date and the name of the analyst In this mode calibrator materials of known concentrations are used to calibrate the instrument so that concentrations of unknown samples may be calculated according to Beer s Law In addition the highest absorbance calibrator will be assigned a value of 100 in the field A Hi Cal and each sample
12. READ The lamp turns on and begins to warm up A built in 45 second countdown is displayed It ends with an audible signal indicating that the instrument is ready NOTE If the lamp is already on the warm up step is bypassed The reader will automatically transport the samples through the optical system Absorbance readings will be displayed and printed Calibrators are identified as CALIBRATOR 1 CALIBRATOR 2 etc in the sample ID column After the first strip is read 2 strips in the 8 well format the reader will pause to ask if you would like to see the curve printed out Answer YES or NO aw Awareness Technology Inc Zug 9y when you see the display PLOT CURVE Y N The plotted curve shows the calibration curve with Concentration on the x axis and A Hi Cal on the y axis If calibrators were read in duplicate the display will ask EDIT WELLS Y N Use the YES or NO key to answer If NO is pressed the instrument will proceed to read and calculate the samples If YES is pressed you will see DELETE WELL displayed Even if well A 1 was the blank consider it as well 1 The second well read is 2 the third well read is 3 and so on Type in the well number that you wish to delete and press ENTER Again you will see DELETE WELL displayed If you wish to delete another well type in its well number and press ENTER You may delete as many as one from each pair but you may not delete an entire point
13. Selecting a Plate Format en 18 2 1 2 Selecting B ModE uu nies aen bns at yeka nan eee kada 18 2 1 3 Quitting a Mode T Y 20 2 1 4 Selecting FIIBES ak A kx kana kaka ak kann kak dak bek ya eo a eE E bela kra ka kra UR ka d n anda a 20 2 1 5 Selecting a TE 21 2 1 6 Selecting UNIS ee TCU kaka ka kenda yl kan Ahaa kan keke d a an Zan w k 21 2 1 7 Selecting Duplicates 22 2 1 8 Selecting Control Options E 22 2 1 9 Selecting Cutoffs 23 2 2 Galoulalan e eler E 24 2 2 1 Absorbance Mode ABS kk kk r KK KK KK 24 2 2 2 Single Calibrator Mode STND 25 2 2 3 Cutoff Mode C OFF 26 2 2 4 Absorbance Multi Point Mode ABS 29 2 2 5 Point to Point Mode PGM 31 2 2 5 Polynomial Mode POLY LLULLU seiten brennen otn 34 2 2 7 Regression Mode ans EEE kk ue pula kek qeu KK KA KK KK KA A 36 2 3 Test Menu a aa EH an n nn 38 23 1 Stoning a TEST Dm 38 e EE le E E EE 38 2 3 3 Recallino TEST Rm 38 2 3 4 Editing a Me
14. When no more deletions are desired press ENTER again The standard curve will be recalculated showing an X beside the deleted well s When a duplicate absorbance is deleted the remaining well will be used as the value for that standard point Again the operator will have an opportunity to plot and to edit This may be repeated as many times as desired until either an acceptable curve is obtained or the mode is cancelled To read and calculate specimens answer NO to the question EDIT WELLS Y N The remainder of the plate will be read calculated and printed To unload a plate simply lift the plate straight up The instrument will display LOAD NEXT PLATE READ To continue reading in the Absorbance Multi Point Mode load the next plate and press the READ key Only the first plate must contain calibrator materials If a calibrator has an absorbance reading greater than 3 0 A the printer will print gt 3 00 for the absorbance reading and the concentration will be calculated and printed The test mode will continue however it is not advisable to use such a highly absorbing material as a reference If a sample has an absorbance reading greater than 3 0 A the printer will also print gt 3 00 for the absorbance reading and the concentration will be calculated and printed Press the STOP key any time after the test has begun to read the second strip third strip in the A H direction if you want to stop the reading w
15. absorbance values must be nonzero and positive If the absorbance value of a well is negative will be printed in the CONC field The instrument can accept calibrator values up to 7 digits and calibrators less than 1000 can accept 2 decimal places If 2 decimal places are desired for calibrators or concentration values the first calibrator must have a 2 decimal place value assigned When all of the calibrator values have been entered the duplicate selections and cutoff options will be displayed Remember to use cutoff options with care especially for equations having negative slopes Then the instrument will display LOAD NEXT PLATE READ You may locate controls and set their ranges at this time following the instructions in section 2 1 8 Selecting Control Options You may use the End function at this time to read only part of a plate by following the instructions in section 2 4 3 End Press the READ key As in the Point to point and Polynomial modes there will be a pause after the first 12 wells are read 16 wells for the 8 well format The instrument will ask if you want to see the regression line plotted Use the YES and NO keys to answer If you do not answer the prompt within 2 minutes the instrument will continue to read the plate until completion 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
16. curve If calibrators were read in duplicate the display will ask EDIT WELLS Y N Use the YES or NO key to answer If you do not answer the EDIT WELLS Y N prompt within 2 minutes the plate is read to completion If NO is pressed the instrument will proceed to read and calculate the samples If YES is pressed you will see DELETE WELL displayed Even if well A 1 was the blank consider it as well 1 The second well read is 2 the third well read is 3 and so on Type in the well number that you wish to delete and press ENTER Again you will see DELETE WELL displayed If you wish to delete another well type in its well number and press ENTER You may delete as many as one from each pair but you may not delete an entire point When no more deletions are desired press ENTER again The standard curve will be recalculated showing an X beside the deleted well s and the new slope intercept and correlation coefficient will be printed When a duplicate absorbance is deleted the remaining well will be used as the value for that standard point Again the operator will have an opportunity to plot and to edit This may be repeated as many times as desired until either an acceptable curve is obtained or the mode is cancelled To read and calculate specimens answer NO to the question EDIT WELLS Y N The remainder of the plate will be read calculated and printed To unload a plate simply lift the plate straight up
17. darkly colored substance may be used 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 2 Maintenance It is important to follow the installation instructions carefully as described in section 7 4 Installation Adequate clearance and ventilation should be provided as well as a vibration free surface Connections to main circuits with large pumps compressors or refrigerators should be avoided The Stat Fax 2100 is designed to be a maintenance free instrument To insure optimum trouble free performance the instrument should be kept dry and operated in an area free from excessive dust This instrument employs interference filters of advanced technology and will provide extended life in humid environments when compared to standard soft interference filters In general however excessive humidity should be avoided Optimum operating conditions are from 18 to 35 centigrade and less than 80 relative humidity Storage temperatures should not exceed 10 to 50 centigrade Cleaning should be done when necessary Use a slightly damp soft cloth to remove dirt or spills For decontamination 7096 isopropanol is recommended Use of other chemicals or abrasive cleaners is not recommended Care should be exercised not to wet the keypad excessively 3 3 Troubleshooting Using the following guidelines simple probl
18. fingerprints from the bottoms of the plates before using Do not read plates that contain bubbles or condensation Use the same volume for the blank as you use for the samples 2 1 6 Selecting Units In all modes other than Absorbance Mode and the Cutoff Modes you are given the option of selecting units for your concentration values When the display prompts Select units 0 13 you may select the unit code you wish to use Entering 99 will print out the available unit codes shown here 0 Conc 1 AU mL 2 Ratio 3 ugEq mL 4 IU mL 5 ulU mL 6 CAL 7 GPL mL 8 MPL mL 9 EV 10 U mL 11 A mL 12 Abs 13 Selecting unit code 13 will give no unit code To select a unit code enter the number of the code you wish to use The unit code assigned the number you have entered will display on the screen and you may either press Enter to confirm and select or press Clear to choose another unit code Pressing Enter at the Select units 0 13 prompt will display the default of Conc and you still must press Enter again to confirm 2 1 7 Selecting Duplicates In most modes requiring one or more calibrators the operator is given the option of reading either one well or two consecutive wells of each calibrator In the latter case the mean absorbance reading is used as the reference absorbance for that standard The operator will also be given a choice of reading specimens singly or in duplicate If duplicate specimens are sel
19. 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 terminal on the rear panel of the instrument to a suitable ground such as to a grounded pipe or some metal surface to ear
20. instrument will print its number the mode name the plate format PAGE 1 indicating the page number of the test the date and time last modified lines to write in lot number expiration and operator the wavelengths calibrators blank replicates control options and cutoff options which were previously selected If you are recalling a test with a stored curve the display will ask USE STORED CURVE Y N If you select YES then your plate will be read as if all of the wells contained samples The standard curve stored in memory will be recalled to calculate the concentrations If you select NO the instrument will assume that the new plate contains new standards The plate will be read using all of the selections in memory but a new standard curve will be generated using the new absorbance readings The new curve will automatically replace the old curve in memory If you want to enter additional control options do this using the CNTRL key just before reading the first plate The test will be updated after the standard points are read 2 3 4 Editing a Test The edit function is a convenience feature that allows you to make changes to stored tests without reentering all of the selections and without causing the user test numbers to change This is especially useful when a new lot of reagent is received with no test parameter changes required except for the entry of the new calibrator values The stored curve is automatically erased
21. printed when an error occurs in recalling a test This feature assures that recalled values are the same as those which were stored MECHANISM ERROR AT PS W where P is the plate number S is the strip A H and W is the well number is displayed when a mechanical problem in the plate transportation system is detected The printer will also print MECH ERR PS W READ ENDED TEST ENDED See the section 2 4 8 Mechanical Control for information about this message FILTER WHEEL ERR is printed when there is a mechanical problem with the instrument If this occurs turn the unit off and then on again If this fails to clear the problem return the unit for service FILTER LABELS RESET or RUN TEST 248 to RESET FILTERS is displayed when the RAM has been affected such that the filter labels have been erased To restore filter labels select test 248 The filters wavelengths and their respective positions in the filter wheel are listed inside the rear hatch cover on the right hand side To access this list remove the two screws on the back of the hatch cover then pull the hatch cover free to view the list The hatch cover will remain attached to the instrument by a cable CAUTION Note that the positions listed on the filter label list do not correspond directly to the key numbers When the display prompts KEY 5 type in the wavelength for the filter in position 3 on the filter label list ENTER When the display prompts
22. using only a primary filter monochromatically select 0 for the differential filter When reading monochromatically the absorbance is elevated relative to the curvature of the meniscus A correction can be entered by the user to compensate for this effect The correction is termed Offset Absorbance 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 and use this number as your offset absorbance When no differential filter is selected the message OFFSET BLANK ABS Y N will be shown If you answer YES you will see OFFSET ABS Enter the value that you determined should be used as the offset absorbance This value will be subtracted from all absorbance readings to correct for the meniscus effect 3 ADDITIONAL TIPS AND INFORMATION 3 1 Operating Precautions Most errors in clinical laboratory testing are not due to bad reagents or malfunctioning instrumentation but rather to operator error We have taken several steps in the design of Stat Fax 2100 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 The following precautions are offered to further assur
23. when a user test is edited Press the EDIT key followed by the TEST key to make changes to a test in the user test menu The instrument will ask for the test number that you wish to change Then all of the test parameters will be printed for your review One by one the selections will be displayed If you want to edit the displayed parameter select YES ENTER If you want to maintain the current selection press NO and ENTER to move on The display starts with EDIT TEST NAME Y N If you press YES you may edit the name of the test If you press NO the display will show EDIT WAVELENGTHS Y N If you press YES you will have the opportunity to make new wavelength selections If you press NO the display will show EDIT CALIBRATORS Y N If you choose YES you must key in the number of calibrators then you will see KEY VAL C1 ENTER This will continue until all of the parameters have been reviewed Duplicate selections cutoff options and control options will follow Note if you choose to edit the controls other than in cutoff mode you must edit all the controls Then you will see EDIT MODE ENDED printed To run the test with the new parameters press the TEST key and select that test by its number When you are ready to read the first plate a new standard curve will be generated The new curve will be stored under the same test number as before Be sure to update your log 2 3 5 Test Menu Test 99 will print out a Men
24. your second calibrator material Then press the ENTER key This will continue until all calibrator values have been entered Then the printer will print CALBRTR 1 XXXX CALBRTR 2 XXXX CALBRTR 3 XXXX where XXXX represents the calibrator values you acceptable curves entered The instrument can accept calibrator ascendingordescending values up to 7 digits and calibrators less than 1000 monotonic can accept 2 decimal places If 2 decimal places are desired for calibrators or concentration values the first calibrator must have a 2 decimal place value notacceptable assigned mixed direction The display will ask DUPLICATE CALIBRTRS Y non monotonic N Use the YES or NO keys to answer Then the display will ask DUPLICATE SAMPLES Y N Again answer with YES or NO If duplicates are selected this will be indicated on the printout and mean readings will be used Cutoff options will follow Positive gt and Negative lt Refer to section 2 1 9 Selecting Cutoffs for instructions Then the instrument will display LOAD NEXT PLATE READ You may locate controls and set their ranges at this time following the instructions in section 2 1 8 Selecting Control Options You may use the End function at this time to read only part of a plate by following the instructions in section 2 4 3 End Place the first plate into the carrier so that well A 1 is at the right rear then press
25. 22 0 Negative 0 44 43 3 Negative 0 86 0 0 Negative 0 00 CONC J 0 0 0092 REGRESSION LINE 3 7 User Test Menu Log Stat Fax 2100 SN User Test Menu Log page 3 8 Contact Information In the unlikelihood 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 Phone 772 283 6540 Fax 772 283 8020 E mail info awaretech com e Mail Awareness Technology Inc P O Drawer 1679 Palm City FL 34991 USA When contacting Awareness Technology please provide the following the serial number of your instrument a description of the problem with as much detail as possible e printouts which can be submitted to us by mail fax or email
26. ENTER CONTROL LIMITS Neg C must be z As with the positive control enter the high limit for the control Negative controls do not have a lower limit If you wish to enter a low positive control answer NO to the prompts Pos C Y N and Neg C Y N You will then see Lo Pos Y N Answer YES Position this control by Plate Row st and Well then enter its limits as you would those of a positive control After cycling through Pos C Y N Neg C Y N and Lo Pos Y N you will see Exit Y N If you wish to enter more controls select no then enter any additional positive negative or low positive control locations A total of 3 controls any combination may be located and all of the controls of each type will be compared to the range you entered with the first one of that type 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 To find controls on the printout look for Pos Control Neg Control or Lo Pos Ctrl printed immediately after the well number in the SAMPLE ID column In the column labeled Interpretation look for the words Control is HI or Control is LO to determine whether or not the control values are in range In range controls have nothing printed in the Interpretation column 2 1 9 Selec
27. France Belgique Belgi Espana Fisher t l 0388671414 t l 056 260 260 tfno 915159234 2 2 SES fax 0388671168 fax 056260270 fax 915159235 Bioblock Scientific email infos bioblock fr email belgium bioblock com email ventas bioblock com Parc d innovation BP 50111 F67403 illkirch cedex www bioblock com www bioblock be www es fishersci com Stat Fax 2100 Operator s Manual Copyright 1989 2005 Awareness Technology Inc Revised 01 05 Doc 2100 Rev J Table of Contents 1 INTRODUCTION 1 1 1 veris e pe epee SEA A RL 1 1 1 1 Intended RN 1 1 1 2 Summary of the Instrument kk Em tx ato Rida YR 1 1 1 3 Principles of Operation EE 2 1 2 Warning Markings a kk kk kk kK KK KK kk kk KK KK KK KK KK KK UE 3 UAE Rules s six xin ayan an neda nekan mM 3 poe AMI comm 3 1 3 Safety Precautions mc 4 Peline e t 6 1 4 1 General Installation E 6 1 4 2 Printer Requirements gegen due Edge EEN k k kake kk kK KK KA A 7 1 4 3 Serial Connection EE 8 1 4 4 Parallel Printer Operation 8 1 5 Check out Procedure E 10 T G Parts and Controls uuu ccs eee uuu au eaten E E aki Ki xe yana uk kk EENE 11 1 6 1 Parts of the Instrument T o oo 0T 11 1 6 2 Keyboard E Ee 12 INE e ee E 15 2 OPERATING PROCEDURES IIU U J J 17 ER EE 17 2 1 1
28. LE or 6 FILTER UV if applicable and the instrument s serial number Then the reader displays SELECT MODE the date and time Check that the clock and calendar are correctly set for your time zone If you need to set the time and or date follow the instructions in section 2 4 7 Clock and Calendar 1 4 4 Parallel Printer Operation The 2100 series can output text and graphs to an external printer connected to the parallel port Compatible printers are Hewlett Packard Desk Jet series parallel only Canon Bubble Jet BJ series parallel only Epson Dot Matrix Printers and others capable of Epson emulation serial or parallel Configuration To select a pagination mode select Test 101 and press ENTER The display will show New test new page Y N Select YES to print a new sheet each time you begin a new test Select NO to print continuously with page breaks determined by the lines allowed per page At power up the printed header will indicate Test form feed on or Test form feed off To configure the instrument for parallel output to Canon BJ series or Hewlett Packard Desk Jet printers select test 102 The display will show Select printer HP DeskJet To select HP DeskJet press YES Select NO and the display will show Select printer Canon Bubble Jet To select Canon Bubble Jet press YES Select NO and the display will show Select printer Epson Dot Matrix To select Epson D
29. Messages Flags and error messages are printed to alert the operator when he approaches certain limitations of the reader After printing the warnings the instrument will continue to perform regardless of the implications except where indicated below The Stat Fax 2100 employs these messages gt 3 00 is printed in the absorbance field whenever any absorbance exceeds 3 0 A gt Reference is printed when a sample exceeds the absorbance of the reference well well 1 in a log logit test gt 10 7 is printed as the concentration value whenever the calculated result is greater than 7 digits and can not be properly printed in the concentration field Curve is invalid is printed in the interpretation field in the Absorbance Multipoint or Point to Point Modes when a non monotonic curve a curve in which the slope is neither consistently positive OR consistently negative is read Invalid Regression is printed in a logarithmic regression if the standard curve requires the log of a negative or zero number OFF is printed in the Polynomial Mode when an absorbance exceeds the maximum teme is printed in the Ln 1000 ABS regression mode when an absorbance is negative lt 0 0 CONTROL BUFFER FULL is displayed if a fourth control location is attempted MEMORY FULL is displayed when no more user tests can be stored Deletions must be made before adding any new tests MEMORY ERROR is
30. Negative values to be all values less than the cutoff value The display will then 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 labeled Equivocal The Cutoff Mode also offers you the option of adding a QC parameter for the minimum cutoff value In the event the mNC absorbance reads less than the specified minimum the Min COV is used as the cutoff After entering the X Y and FAC values and the Equivocal range prompts If Y 0 and FAC 0 the display will prompt Use Min COV Y N Press NO unless your test specifies a minimum absorbance value for the cutoff Press YES to use the minimum COV as the cutoff instead of the mNC if the mNC absorbance reads less than the specified minimum COV The display then shows Min COV Enter the minimum cutoff value If X mNC gt Min COV the cutoff will be X mNC If X mNC lt Min COV the cutoff will be Min COV The instrument then asks for the number of each type of control to be read It will also ask for the absorbance acceptance criteria for the mean of each type of control it of Neg Controls Neg C must be lt of Pos Controls Pos C must be gt NOTE All controls plus the blank must fit into 8 wells Next the in
31. R Communicates to the instrument that the operator is finished providing keyboard input Generally the ENTER key causes the instrument to move on to the next prompt YES and NO keys are used to answer yes and no questions They are on the 1 and 0 keys and only serve these functions when a yes or no question is asked in the display The Alpha Set The primary function of the alpha keys A H is to locate wells The other lower functions on this key set are the positive and negative signs a colon used in editing time and a slash mark used in editing date Just as with the numeric keys lower functions are only available when a question requiring their use is being displayed by the instrument Use of non volatile memory involves the upper function keys STORE DEL EDIT and TEST STORE is used to add a new test number DEL DELETE is used to completely erase a test number making that memory location available for a future test EDIT is used to edit a test in memory and also to change the time and date and TEST is used to recall a rest from the stored test menu TEST Accesses stored user tests TIME Pressing EDIT TIME allows for changing the time and date 8X12 Configures the reader for 8 or 12 well reading format Aux1 Format Plate Allows the user to set up a plate containing multiple tests SelfCk Initiates an automatic function check Mix Causes the plate to move inside the instrument and mix for a specified time interval STOP Stop
32. al Connection For connecting the instrument to either a serial printer or a computer serial port a custom double ended cable is provided Itis a nonstandard cable available through your instrument dealer If your equipment requires a different plug configuration you may need to purchase the appropriate adapter CAUTION Consult the manual of the PC or printer for the correct pin connections and type of connector before transmitting data Also consult the instruction manual of your printer or PC to set up the receiving equipment for serial data input This is generally done by setting dip switches The serial receptacle of the plate reader is located on the left 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 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 instrument and the external printer off plug in both ends of the cable provided Then plug in and turn on the printer installing printer paper if needed Finally turn on the plate reader It is important to have the receiving equipment ready before starting up the plate reader otherwise data might be lost The display will indicate Stat Fax 2100 followed by a software code the time and date This information will also be printed as well as 6 FILTER VISIB
33. alibrator the absorbance of calibrator is generated in this mode and then multiplied by subsequent absorbances to determine concentrations Multi point calibration modes In the Absorbance Multi Point Mode the instrument accepts a number of calibrators from 2 to 7 read singly or in duplicate It then calculates concentrations based on the point to point calibration curve assigning the highest absorbance calibrator as 100 Blanking graphing and editing options are available In the Point to Point Mode the instrument accepts a number of calibrators from 2 to 7 read singly or in duplicate It then calculates concentrations based on the point to point calibration curve Blanking graphing and editing options are available In the Polynomial Mode the instrument accepts a number of calibrators from 3 to 7 subsequently calculating concentrations based upon the best fit polynomial regression calibration curve The polynomial mode is designed for parabolas that open downward and the lower concentration result is reported No blank is allowed Graphing and editing options are available In the Regression Mode the instrument accepts a number of calibrators from 2 to 7 subsequently calculating concentrations based on the best fit linear regression Data may be entered for linear linear In natural log linear linear In or In In calculations A logit log calculation is also available Blanking graphing and editing options ar
34. and calibrator is reported in that field as a percent of the absorbance of the highest calibrator If you wish to use the point 0 0 as a calibrator you must put the blank material in a calibrator well and assign it a concentration of 0 Be sure to use at least 2 calibrators since two points are necessary to describe a line The resulting calibrator curve is a series of lines connecting the calibrator points which may be entered in ascending or descending order of absorbance The direction of slope between the first and second calibrators determines the direction of the curve If the direction of the curve changes the curve will be flagged as invalid and no interpretations will be printed Unknown samples are calculated as follows First the unknown sample s absorbance is read and compared to the calibrator absorbances Then the line selected as the calibration curve for determining the concentration of the unknown is the line 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 An unknown sample whose absorbance is lower than the lowest calibrator absorbance is calculated from the line passing through the two lowest standards For calibrators read in duplicate dispense the duplicates in consecutive wells When reading in the 12 well d
35. avelength combination for your chromophore c Wells should not have bubbles condensation floating material severe scratches or smudges d Review the procedure for blanking Remember to use the same volume for the blank and the samples e Be certain that you are reading in the correct position Refer to the operating instructions for correct placement of the blank and calibrator materials f Check the printer to be sure that no flags were printed that would indicate improper results see section 2 4 5 Flags and Error Messages for a review of flags and error messages Problem The instrument lacks reproducibility Solution a Be certain that the table or lab bench is free of vibration b If reproducibility of a plate is poor check that the reaction has completely stopped c Remove the plate press the BLANK key and press the READ key to check the repeatability of the instrument on air If there are no electronic problems readings should be within 0 000 0 003 If greater values are observed the instrument will require service d Check that the wells are positioning properly This can be done by inserting a DRI DYE Check Strip for multiple readings OR a plate with water and surfactant in all wells A plate of 96 wells of uniformly pipetted water surfactant read in the absorbance mode and blanked on the first well should consistently provide results within 0 01A e Very high absorbance readings are noi
36. brators or concentration values the first calibrator must have a 2 decimal place value assigned Nw Awareness Technology Inc Zug gy The display will ask DUPLICATE CALIBRTRS Y N Use the YES or NO keys to answer Then the display will ask DUPLICATE SAMPLES Y N Again answer with YES or NO If duplicates are selected this will be indicated on the printout and mean readings will be used Cutoff options will follow Positive gt and Negative lt Refer to section 2 1 9 Selecting Cutoffs for instructions Then the instrument will display LOAD NEXT PLATE READ You may locate controls and set their ranges at this time following the instructions in section 2 1 8 Selecting Control Options You may use the End function at this time to read only part of a plate by following the instructions in section 2 4 3 End Place the first plate into the carrier so that well A 1 is at the right rear then press READ The lamp turns on and begins to warm up A built in 45 second countdown is displayed It ends with an audible signal indicating that the instrument is ready NOTE If the lamp is already on the warm up step is bypassed The reader will automatically transport the samples through the optical system Absorbance readings will be displayed and printed Calibrators are identified as CALIBRATOR 1 CALIBRATOR 2 etc in the sample ID column After the first strip is read 2 strips in the 8 well
37. c 1 Neg Control 0 180 IC d Mean of 2 NCs 0 186 lD 1 Pos Control 0 531 ip 1 1E 1 Pos Control 0 515 1E 1 Mean of 2 PCs 0 523 C O ABS 0 547 IF 11 0 768 1 402 Positive lF 1 1G 1 2 0 008 0 014 Negative 1G 1 1H 1 3 0 271 0 495 Negative lH 1 1A 2 4 0 002 0 003 Negative 1A 2 1B 2 5 0 403 0 736 Negative 1B 2 1C 2 6 0 150 0 274 Negative ic 2 1D 2 7 0 070 0 128 Negative 1D 2 1E 2 8 0 123 0 224 Negative lE 2 1F 2 9 0 224 0 408 Negative lF 2 IG 2 10 0 406 0 742 Negative 1G 2 1H 2 il 0 005 0 010 Negative lH Z END OF RUN TEST ENDED COV 2X mNC Y mPC4FAC 8 LOT NUMBER WAVELENGTHS 492NM 630NM POS COV NEG COM BLANK MUST BE WELL 1 Blank must be gt 30 500 COV 0 50 mNC 0 050 of Neg Controls 2 Neg C must be gt 0 500 of Pos Controls 2 Pos C must be lt 0 500 mP mN must be lt 1 500 Last Well is at 1H 02 PLTE WELL SAMPLE ID 1A 1 Blank 2 1B 1 Neg Control 1 1c 1 Neg Control i Mean of 2 NCs 1 813 1D 1 Pos Control __ Q lE 1 Pos Control __ O Mean of 2 PCs 0 425 C O ABS 0 956 1F 11 J 1G 12 1 1H 1 3 D 1A 2 4 D 1B 2 5 D 1c 2 6 1 1D 2 7 1 1E 2 8 D IF 2 9 D 1G 2 10 1 1H 2 11 1 END OF RUN TEST ENDED PAGE EXP ABS 335 899 2727 2337 493 102 145 303 287 446 098 135 503 566 096 192 03 09 98 15 48 43 USER INTERPRET 1A 1B 1C 1D 1E Negative lF Negative 16 Positive 1H Posi
38. celled If a sample has an absorbance reading greater than the absorbance maximum on the best fit curve the instrument will print OFF next to the concentration Press the STOP key any time after the test has begun to read the second strip third strip in the A H direction if you want to stop the reading without quitting the mode 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 and return the plate to the home position 2 2 7 Regression Mode This is a multi point calibrator mode that calculates a best fit linear equation based upon the standard points It is designed for use with either linear or logarithmic data with absorbance on the y axis and concentration on the x axis When you select the REGR key the printer prints REGRESSION MODE 8 or 12 to indicate the selected plate format PAGE 1 indicating the page number of the test the date and the time Spaces will be provided to write in the lot number expiration date and the name of the analyst After the filters are selected if you chose no differential the Offset Absorbance questions will follow see section2 4 9 Monochromatic and Offset Absorbance for instructions Then you will see AXES SETUP SELECT There are four possible formats The first choice displayed is Y ABS X CONC for the case where both the absorbance data y and the c
39. centrations 8 Will locations of 1 or more controls be marked If so you will need to indicate plate number row number and well number for each 9 Will acceptance cutoffs or ranges for controls be entered for automatic comparison If so what cutoffs or ranges are to be used for each 10 Will a cutoff value be used to label positive samples If so the value which begins the positive range will be required 11 Will a cutoff value be used to label negative samples or define an equivocal zone If so results less than what cutoff should be labeled as negative 12 Will this test be stored If so you must remember to store it before you cancel the mode 13 For multi point modes with duplicate standards the instrument will ask if you wish to delete points from the standard curve before proceeding What criteria will be used to determine bad curves If you do not accept a curve 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 2 1 1 Selecting a Plate Format To begin turn the instrument on and see SELECT MODE 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 READ key the display will indicate LAMP WARM UP XXX SECS where XXX represents the number of seconds remaining
40. ch general purpose calculation program Section 2 3 Test Menu explains how to create and use your own test menu stored in non volatile memory Finally section 2 4 Special Features provides specific details on the operation of each additional special feature i e mixer date and time printer etc 2 1 General Selections Although many features are available to aid the user this instrument may be operated in most modes by pressing ENTER to bypass questions relating to extra optional features For every test the instrument will require a mode selection and filter combination Thereafter only those questions that pertain to the 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 calculating program will be used 2 What filters are optimal operating and differential wavelengths 3 If reading monochromatically how much absorbance offset is necessary 4 Is a blank required desired 5 How many calibrators will be used Note for the purpose of this manual the terms calibrator and standard are used interchangeably to designate reference materials of known concentrations 6 What is the calibrator value or values 7 Will calibrators and or specimens be read in duplicate or singly Note for the purpose of this manual the terms specimen and sample are used interchangeably to mean materials of unknown con
41. d as above except rated 250 V with a tandem blade grounding type attachment plug The cord set provided by the manufacturer meets 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 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 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 A Warning 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 a 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 switc
42. dicating the page number of the test the date and the time Spaces will be provided to write in the lot number expiration date and the name of the analyst In this mode a single calibrator material of known concentration is used so that concentrations of unknown samples may be calculated according to Beer s Law The monochromatic or bichromatic absorbances at the user selected wavelengths will be read and the instrument will automatically blank on well A 1 and subtract its absorbance from each subsequent well After the filters are selected if you chose no differential the Offset Absorbance questions will follow see section 2 4 9 Monochromatic and Offset Absorbance for instructions The display then prompts you to enter your desired unit code with Select units 0 13 see section 2 1 6 Selecting Units for instructions The instrument will then display KEY VAL C1 ENTER Type the concentration value assigned to your calibrator material then press the ENTER key The printer will print CALBRTR 1 XXX where XXX is the calibrator value you have entered The instrument can accept calibrator values up to 7 digits and calibrators less than 1000 can accept 2 decimal places If 2 decimal places are desired for calibrators or concentration values the first calibrator must have a 2 decimal place value assigned The display will ask DUPLICATE CALIBRTRS Y N Answer by pressing the YES or NO key Next the display will a
43. e available Absorbance or In of 1000 absorbance is always on the Y axis and concentration or In of concentration is always on the X axis Cutoff modes In the Cutoff Control Test a number of negative controls are read then a number of Cutoff Controls followed by a number of positive controls Blanking on the first well is optional The instrument calculates the mean of each set of controls and uses the mean of the cutoff controls as the cutoff value It also calculates the ratio of the means for QC purposes 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 You may choose either the regular cutoff mode positive gt cutoff negative lt cutoff or the reverse cutoff mode positive lt cutoff negative gt cutoff The instrument calculates the mean of the positives and the mean of the negatives It also calculates the ratio of 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 This determines a cutoff point for interpretation of subsequent specimens 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 the section 2 3 Test Menu for instructions on adding a t
44. e quality laboratory results Read your instrument instruction manual before performing any testing then keep it handy as areference 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 plates is removed from the results In order to preserve sensitivity however it is important not to use differential readings at 630nm when the chromophore which you are reading exhibits substantial absorbance at or near 630nm It is also advisable to make dilutions of solutions that exceed 2A and understand the relationship of read volume to absorbance Use clean plates and follow the instructions for blanking and standardizing very closely Use of the appropriate blanking material is also very important water is not always specified Do not read wells with bubbles or condensation 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 blanking and all absorbance readings Monitoring the printer and display during operation may help you detect an error in the making Check the calibration and linearity of your instrument against some standard reference periodically DRI DYE Check Strips or a carefully pipetted serial dilution of a stable
45. eater than the number of tests to be read the additional sections will not be read Next you will see SELECT STORED TEST ENTER TEST NUMBER Select the number of the test you want to put in the first section The display will then ask SELECT ANOTHER TEST Y N Press the YES key to enter another test then select its test number This step will repeat until you either reach the number of tests you selected to put in the plate or you answer NO to the SELECT ANOTHER TEST Y N prompt The printout of this mode will show the appropriate transposed locations of the controls You may then run the plate If you have fewer tests than you have plate sections the instrument will only read until the end of the final test then end the test Multi Test Format Options 1 12 Direction 4 Tests 2 Tests H Direction 3 Tests A 6 Tests 2 Tests 2 4 Special Features 2 4 1 Mixer To mix the contents of a plate load the plate and press the MIX key The display will read MIX MODE KEY MIX TIME IN SECONDS Type in the number of seconds maximum time 999 seconds and press ENTER The display will show LOAD NEXT PLATE READ Press the READ key The plate will be transported into the instrument then mixed until the time has elapsed Then the plate will return to the home position 2 4 2 Printer For information on the selection and installation of the printer refer to section 1 4 nstallation An external se
46. ected the mean absorbance reading will be used to calculate a single concentration and any subsequent labeling of that sample will be based upon that single result Remember that the blank well is always read singly To make your selections use the YES and NO keys to answer the following two questions when they come up in the display DUPLICATE CALIBRTRS Y N then DUPLICATE SAMPLES Y N If you choose duplicates in either case your selections will be printed Duplicates must be pipetted into consecutive wells Plates read in the 12 well direction are calculated beginning with well A 1 A 2 A 3 A 4 to A 12 and then B 1 B 2 B 3 etc Side by side duplicates A 1 B 1 will not pair up Plates read in the 8 well direction are calculated beginning with well A 1 B 1 C 1 to H 1 and then A 2 B 2 C 2 etc If samples are being read singly the instrument will assume that controls are also being read singly if samples are being read in duplicate the instrument will assume that controls are also being read in duplicate When using the controls locator feature it will only be necessary to label the location of one member of the control duplicate pair See section 2 1 8 Selecting Control Options below for more information about the controls locator feature When using the best fit modes the absorbances of duplicates will be averaged to designate a single point For example consider a 3 point linear regression for which
47. ed The results are printed in a column labeled INDEX The index equals the resulting concentration divided by the positive cutoff 2 2 Calculation Programs 2 2 1 Absorbance Mode ABS When you select the ABS key the printer prints ABSORBANCE MODE 8 or 12 to indicate the plate format PAGE 1 indicating the page number of the test the date and the time Spaces will be provided to write in the lot number expiration date and the name of the analyst In the absorbance mode the monochromatic or bichromatic absorbances at the user selected wavelengths will be read The differential absorbance will be displayed and printed If a blank is required fill well A 1 with the blank material In this mode the instrument will not blank unless you press the BLANK key before the READ key After the filters are selected if you chose no differential the Offset Absorbance questions will follow see section 2 4 9 Monochromatic and Offset Absorbance for instructions Then the reader displays LOAD NEXT PLATE READ You may use the End function at this time to read only part of a plate by following the instructions in section 2 4 3 End Place the plate into the carrier so that the first well A 1 is at the right rear When the plate is in place press the READ key If the lamp is off it will turn on and begin to warm up as a built in 45 second countdown is displayed The countdown will end with an audible signal indicating
48. ems 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 The lamp does not light or the LAMP OUTPUT LOW message appears Solution Lamp replacement is an infrequent event since your lamp is rated to read over 1000 hours and your lampsaver feature minimizes idle time Lamp replacement is only indicated if the lamp does not light or if the output message indicates low intensity Call your dealer to arrange for lamp replacement service Problem The instrument is several years old and has lost some linearity with time Solution Filters are expected to last for at least 3 years under normal environmental conditions Most will last much longer than that but eventually you may need new filters Return the instrument for replacements To retard the deterioration of filters store the instrument in an air conditioned environment and do not expose to severe temperature shock If necessary call your dealer to arrange for service Problem Incorrect answers are obtained Solution a Check that the procedures and materials used were valid b Be sure that you are reading in the specified range of the instrument and using an appropriate w
49. ence of the two absorbances absorbance at operating filter minus absorbance at differential filter 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 made relative to reading air no plate or contents The difference between a water blank and an air blank read bichromatically is typically less than 0 010 A The Single Calibrator Mode requires that a blank be used in well A 1 The material of choice is a reagent blank that best defines the absorbance of zero concentration The polynomial mode operates without a blank For all other modes use of a blank is optional If a blank material is used it must always be in well A 1 and it is always read singly BLANK will be printed to indicate that the absorbance of the first well has been blanked The absorbance which is printed for well A 1 is the absorbance of the blank material relative to air This absorbance value is automatically subtracted from subsequent absorbances before printing and calculating In the absorbance mode blanking is accomplished by pressing the BLANK key prior to reading a plate In all other modes with a blanking option the question BLANK Y N will be shown in the display during the test set up Press the YES key to blank and well A 1 of the first plate will be blanked TIPS wipe any dust or
50. ess the EDIT key followed by the TIME key If the MM DD YY format has been selected the display will ask for the month 1 12 the day and the year 2 digits for each entry Separate the entries using the slash key and press ENTER when the date is correctly displayed Alternately if the DD MM YY format has been selected the display will ask for the day month 1 12 and the year 2 digits for each entry Separate the entries using the decimal point key and press ENTER when the date is correctly displayed Then the instrument will ask you to enter the hour 1 24 minutes 0 59 and seconds 0 59 When entering hour use military time 13 for 1 PM 14 for 2 PM etc Separate hours from minutes and minutes from seconds using the colon key Press ENTER when the displayed time is correct Once set the time and date will not be lost when the instrument is turned off The time may be viewed whenever a mode is cleared since the instrument displays both the date and time Whenever a mode is selected the printer prints the date and time on the report The dates and times of changes made to the test menu are also recorded in the non volatile memory 2 4 8 Mechanical Control Accurate positioning of each well in the optical system is a requirement affecting instrument precision To assure exact positioning the instrument is programmed to check its alignment in the home position before reading every plate If your instrument seems to pause mome
51. est To cancel a mode press the Clear key twice This may be done at any time 2 1 4 Selecting Filters The modes all begin by asking you to choose an operating filter and a differential filter The filter choices along with their Keyboard assignments will be displayed Note The instrument should be used bichromatically Use monochromatic readings only when no appropriate bichromatic wavelength is available The filter choices are shown below along with their keyboard assignments 2100 2100 Six UV 2100 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 When you see SELECT FILTERS in the display press the key corresponding to the wavelength of your choice See your selection in the display If it is incorrect press the clear key once and select again When you see the correct selection in the display press the ENTER key SELECT DIFFERENTIAL FILT will then be displayed Again use the numbered keys to select the desired wavelength or the 0 zero key for no differential wavelength and press ENTER Your filter choices will be printed and the operating mode will continue When reading monochromatically you may want to exercise a special feature called offset absorbance See the section 2 4 9 Monochromatic and Offset Absorbance for more details The instrument will read every well at both wavelengths reporting the differ
52. except that rather than connecting the points with a series of linear segments a smooth curve is generated The curve is the best fit quadratic equation calculated from the calibration points using a least squares method of fit Choose this mode only for parabolas in which the vertex is at the top and represents the highest absorbance that can be interpolated to a concentration value The parabola opens downward ideally crossing the x axis close to the point 0 0 The quadratic equation is then solved for each absorbance and the lower mathematical solution becomes the specimen concentration Calibrator Vertex of Curve Points NE _ absorbance side mirror side Absorbance Polynomial Curve Concentration The standard curve will have the equation y ax 2 bx c where a lt 0 Absorbances must have positive values The coefficients a b and c will be printed as will the maximum absorbance and concentration vertex point Then the operator will be given the opportunity to print the curve for visual examination and to edit the curve by deleting one or more duplicates before calculating samples When you select the POLY key the printer prints POLYNOMIAL MODE 8 or 12 to indicate the selected plate format PAGE 1 indicating the page number of the test the date and the time Spaces will be provided to write in the lot number expiration date and the name of the analyst After the filters are
53. f characters ABCDEFGHIJKLMNOPQRSTUVWXYZ 1234567890 _ is shown in the display Use the 4 key to move the cursor to the left the 6 key to move to the right When the cursor is positioned over the correct character press the READ key When you have finished entering the test name press the ENTER key The instrument will print and display SAVED AS USER TEST XX YY UNUSED where XX represents the next available test number and YY represents the remaining number of available test soaces Be sure to update your test log 2 3 2 Deleting a Test To completely remove a test from the user menu press the DEL key The instrument will ask for the test number to be deleted Type in the number and press the ENTER key The instrument will display DELETE USER TEST XX Y N Use the YES key 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 Pressing the NO key will abort the deletion To erase the entire memory delete all user tests press TEST and enter 183 ERASE ALL TESTS Y N will be displayed If you select YES the display will return to SELECT MODE and the time and date will be displayed All stored tests will be cleared 2 3 3 Recalling a Test To select a stored test press the TEST key and you will see SELECT STORED TEST ENTER TEST NUMBER Press the key s corresponding to the test number of your choice then press ENTER The
54. for 1 plate in about 2 minutes DiSplay 2 ttm e eee uu 24 character x 2 line liquid crystal display LCD Keyboard au E eet rua 29 key enunciating membrane switch Calculation Modes Absorbance only single point calibration from a standard cutoff absorbance multi point curve fit point to point curve fit best fit linear In log logit and quadratic Other features Mixer real time clock self check system controls locator partial plate reading complete user prompting flags and error messages cutoff comparisons curve editing and graphing monochromatic option read format 8 vs 12 direction SOM lll POM eS Output only 2400 Baud 1 start bit 8 data 1 stop no parity no handshake serial cable provided el Switch selectable power supply 115V or 230V indicated Voltage Source 110 120V 220 240V Frequency 50 to 60Hz Power Consumption less than 50 Watts Fuse two 1 2 A T rating 250V slo blo 3AG type fuses All power cords must be approved for the country of use Certifications and Compliances Listed to UL Standard 1262 Laboratory Equipment CE Certificate of Conformity Conforms to the following standards EN 50082 1 and EN 55022 following the provisions of the 89 336 EEC directive Physical Encdosure isirsrcininisesisnedssidairi irena Fire retardant ABS Plastic cover with metal base DIMENSIONS sis erento nanan
55. format the reader will pause to ask if you would like to see the curve printed out Answer YES or NO when you see the display PLOT CURVE Y N If you do not answer the prompt within 2 minutes the instrument will continue to read the plate until completion The plotted curve shows the calibration curve with Concentration on the x axis and Absorbance on the y axis If calibrators were read in duplicate the display will ask EDIT WELLS Y N Use the YES or NO key to answer If you do not answer the EDIT WELLS Y N prompt within 2 minutes the plate is read to completion If NO is pressed the instrument will proceed to read and calculate the samples If YES is pressed you will see DELETE WELL displayed Even if well A 1 was the blank consider it as well 1 The second well read is 2 the third well read is 3 and so on Type in the well number that you wish to delete and press ENTER Again you will see DELETE WELL displayed If you wish to delete another well type in its well number and press ENTER You may delete as many as one from each pair but you may not delete an entire point When no more deletions are desired press ENTER again The standard curve will be recalculated showing an X beside the deleted well s When a duplicate absorbance is deleted the remaining well will be used as the value for that standard point Again the operator will have an opportunity to plot and to edit This may be repeated as ma
56. h and slide it into its alternate position Upon sliding the switch you will see the 115V label appear A Warning 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 for a moment When you turn the instrument back on it will resume normal operation but a standard curve which was not stored in non volatile 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 A WARNING 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 4 2 Printer Requirements Either an off line pr
57. he results of assays including in vitro clinical diagnostic assays which are read in microtiter plates This general purpose instrument is intended to be used by trained laboratory professionals 1 1 2 Summary of the Instrument This 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 340 nm and a six filter VIS model 405 450 492 630 545 and 600 nm Substitute wavelengths in the range of 340 nm 700 nm are available on specially ordered models It accepts all standard microplates whether the wells have flat or round bottoms Trays containing microstrips may also be read The instrument can be configured to read and format printed data in either the 12 well 1 12 direction or the 8 well A H direction to accommodate both types of assays The instrument automatically positions the plates blanks reads calculates and sends the results to an external serial printer Alternately the data may be output to a computer which has been programmed to accept serial data A serial cable is provided as a standard accessory More information about the printer requirements and instructions for serial connection are given in this manual 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 t
58. he CLEAR key twice to cancel the test then set up the next test 5 When using this option you may not use any stored curves However the curve generated if valid will be stored over any curve previously stored with that test After setting up all your tests you are now ready to run the Multi Test Format Press the Aux1 key which is used to format the plate for running the multiple tests In the A to H direction the plate can be divided into halves with each section consisting of 6 8 well strips thirds with each section consisting of 4 strips or sixths with each section consisting of 2 strips In the 1 to 12 direction the plate can be divided into halves with each section consisting of 4 12 well strips or quarters with each section consisting of 2 strips The first question the instrument will ask is for the read direction READ MODE A to H Y N Answer YES if you are reading 8 well strips and NO if you are reading 12 well strips The instrument will begin formatting the plate by asking HOW MANY TESTS IN PLATE This question is used to divide the plate into sections If you want to divide the plate in half press 2 ENTER if you are running more than two tests or if you have a smaller run and wish to have less empty space between tests e g if you are running two tests and have only enough samples to fill 2 strips each select 3 or 6 in the A to H mode or 4 in the 1 to 12 mode If you enter a number of sections gr
59. his will be indicated on the printout and mean readings will be used Cutoff options will follow Positive gt and Negative lt Refer to section 2 1 9 Selecting Cutoffs for instructions The instrument will then prompt LOAD NEXT PLATE READ You may locate controls and set their ranges at this time following the instructions in section 2 1 8 Selecting Control Options You may use the End function at this time to read only part of a plate by following the instructions in section 2 4 3 End Then load the first plate with well A 1 at the right rear and press the READ key After the first strip is read two strips in the 8 well format the instrument will pause to ask if you would like to see a graphic representation of the curve printed PLOT THE CURVE Y N is displayed If you do not answer the prompt within 2 minutes the instrument will continue to read the plate until completion Press YES ENTER to print the polynomial curve or NO ENTER to bypass the option Then the coefficients and vertex will be printed Check the coefficient a to be sure that it is negative If a is not negative then the POLY mode is not applicable to the particular calibration data If calibrators were read in duplicate the display will ask EDIT WELLS Y N Use the YES or NO key to answer If you do not answer the EDIT WELLS Y N prompt within 2 minutes the plate is read to completion If NO is pressed the instr
60. identify the location of a positive control press the YES key For all controls the instrument will first ask for the plate number by displaying PLATE 1 9 Use only 1 9 and then press ENTER The instrument will then ask for the row designation as ROW A H Identify the row using the keys A H and then press ENTER Next the instrument asks for the well number as WELL 1 12 Type in the well number 1 12 and then press ENTER Leading zeros are not needed When you finish locating the first positive control the instrument asks for the greatest acceptable value for the positive controls by displaying Pos C must be lt The upper and lower values that you enter for the positive controls will be considered in 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 your calibrators Type in the upper limit and press ENTER Then the instrument will display Pos C must be Type in the lower limit and press ENTER All criteria must be entered for the controls do not press ENTER to bypass any QC checks The instrument will then display LOAD NEXT PLATE 4 READ again If you answer NO to the prompt Pos C Y N you will see Neg C Y N If you want a negative control press the YES key Position this control by Plate Row and Well The instrument will then display
61. ill be flagged as invalid no interpretations will be printed and in the event the test has been stored the curve will not be stored Unknown samples are calculated as follows First the unknown sample s absorbance is read and compared to the calibrator absorbances Then the line selected as the calibration curve for determining the concentration of the unknown is the line 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 An unknown sample whose absorbance is lower than the lowest calibrator absorbance is calculated from the line passing through the two lowest standards For calibrators read in duplicate dispense the duplicates in consecutive wells When reading in the 12 well direction with no blank for example put the first calibrator into both wells A 1 and A 2 The second calibrator will be pipetted into well A 3 and A 4 and so on The mean absorbance reading of each pair will be used in the calculations After the filters are selected if you chose no differential the Offset Absorbance questions will follow see section 2 4 9 Monochromatic and Offset Absorbance for instructions The instrument will then ask BLANK Y N Use the YES or NO key to indicate your choice Then the reader will ask how many calibrators
62. ing pathlength and minimal transfer error are important since the tolerance limits which you will establish must take into consideration the sources of error that are not due to the instrument Pipetting errors can be identified by comparing duplicate readings The instrument should give the expected value 1 of the expected value 01A For example if the 1 4 dilution reads 520 A then you can expect your 1 2 dilution sample to read twice as much or 1 04 A 196 of 1 04 0 01 A which is 02 A good working instrument would then give a result between 1 02 A and 1 06 A You will know that your filters are deteriorating when your darkly colored solutions consistently read lower than expected Since the procedures for verifying the calibration and linearity of a vertical photometer are quite cumbersome and not conducive to stringent criteria the best way to assure quality instrument performance is with DRI DYE Check Strips When running assays you should also include a sufficient number of controls in each assay to cover the entire clinical range 2 4 7 Clock and Calendar Before setting the time and date you may select the preferred date format either day period month period year or month slash day slash year To do this press the TEST key and enter 100 to access the date format switch located at TEST 100 To select MM DD YY press the 0 key and to select the DD MM YY format press the 1 key To set the time and date pr
63. inter off line and use the line feed function This allows the printer to track the spacing correctly This function may not work properly when curves are plotted 2 4 3 End This key allows you to stop reading at a designated well It may be used in any mode when the display is showing LOAD NEXT PLATE When you press the END key the display will show Where is Last well The instrument will first ask for the plate number 1 9 then the row letter A H and finally the well number 1 12 Leading zeros are not needed Ensure that all calibrators and controls will have been read before the selected end location is reached Only one End location may be entered for each plate After that location is read the plate reader will stop and return to home END OF RUN will be printed The mode will not be cancelled End locations are not stored in non volatile memory when tests are saved 2 4 4 Lamp Saver Feature To prolong the lamp life the instrument is programmed to turn off the lamp automatically after about 10 minutes of idle time To turn the lamp back on press the Lamp key The lamp will warm up for 45 seconds after which you may select a new mode or proceed to operate in the current mode with no need to re blank or recalibrate Pressing the READ key while the lamp is off will also cause the lamp to turn on and warm up If you want to turn off the lamp without turning off the instrument use the Lamp key 2 4 5 Flags and Error
64. inter or a computer must be used with this reader to record the test data and results The printout provides a permanent record of the date and time modes filters and other test parameters used If data is output to a via the serial port you will require software for data management Contact your dealer for information on serial connection to a PG The instrument does not require a PC It is designed for use with a serial printer that prints 80 characters per line and has a buffer capacity of at least 2000 characters 2K bytes This specification is met or exceeded by most commercially available printers Any print type i e ink jet thermal impact etc may be used The instrument uses EPSON emulation other emulation modes may provide incorrect handling of control codes resulting in incorrect bolding underlining condensed printing etc Serial printers are also available from Awareness Technology consult your dealer Alternately you may choose to use your Stat Fax 2100 microplate reader with the additional parallel interface If so you may use a standard parallel cable DB 25 connector to connect your parallel printer The parallel port is located on the rear of the instrument above the rear panel in the center of the back part of the hatch cover NEVER USE THE PARALLEL PORT OR CABLE FOR A SERIAL DEVICE With the parallel interface you will have full handshake Both serial and parallel ports may be used simultaneously 1 4 3 Seri
65. irection with no blank for example put the first calibrator into both wells A 1 and A 2 The second calibrator will be pipetted into well A 3 and A 4 and so on The mean absorbance reading of each pair will be used in the calculations After the filters are selected if you chose no differential the Offset Absorbance questions will follow see section 2 4 9 Monochromatic and Offset Absorbance for instructions The instrument will then ask BLANK Y N Use the YES or NO key to indicate your choice Then the reader will ask how many calibrators will be used by displaying KEY OF CALS ENTER Up to 7 may be used if read singly in either 8 well or 12 well format or if read in duplicate in the 8 well format The entire calibration curve including any blank must be contained in 12 wells for the 12 well format i e 6 duplicate calibrators without a blank or 5 with a blank Type the number of calibrators then press the ENTER key The display then prompts you to enter your desired unit code with Select units 0 13 see section 2 1 6 Selecting Units for instructions Next the instrument will ask you to enter the first calibrator value by displaying KEY VAL C1 ENTER Type the concentration value assigned to your first calibrator material Then press the ENTER key The instrument will then ask you to enter the second calibrator value by displaying KEY VAL C2 ENTER Type the concentration value assigned to
66. ithout quitting the mode 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 Storing this test will not store the calibration curve Press the CLEAR key twice to cancel the mode and return the plate to the home position 2 2 5 Point to Point Mode PGM The Point to Point Mode is a multi point calibrator mode that allows the operator to enter as many as seven different calibrator concentrations When you select the PGM key the printer prints POINT TO POINT MODE 8 or 12 for the plate format PAGE 1 indicating the page number of the test the date and the time Spaces will be provided to write in the lot number expiration date and the name of the analyst In this mode calibrator materials of known concentrations are used to calibrate the instrument so that concentrations of unknown samples may be calculated according to Beer s Law If you wish to use the point 0 0 as a calibrator you must put the blank material in a calibrator well and assign it a concentration of 0 Be sure to use at least 2 calibrators since two points are necessary to describe a line The resulting calibrator curve is a series of lines connecting the calibrator points which may be entered in ascending or descending order of absorbance The direction of slope between the first and second calibrators determines the direction of the curve If the direction of the curve changes the curve w
67. itive values to be all values greater than or equal to the cutoff value Any samples with absorbances falling between these ranges will be labeled Equivocal The instrument then asks for the number of each type of control to be read You may select 0 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 of Neg Controls Neg C must be lt of COV Controls COV C must be gt of Pos Controls Pos C must be gt NOTE All controls plus the blank must fit into 8 wells Next you will be prompted to enter an additional quality control value This is a check of the ratio between the positive and negative controls to assure adequate distinction When you see the prompt mP mN must be gt enter the lowest acceptable ratio for the mean of the positive controls to the mean of the negative controls or press enter to bypass the option Many options not required can be bypassed by pressing ENTER Once all values have been entered the instrument will display LOAD NEXT PLATE amp READ You may use the End function at this time to read only part of a plate by following the instructions in section 2 4 3 End Load the first plate and press the READ key The instrument will then begin to read the plate and print the results labeling the controls as Neg Control
68. lean 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 amp BIOHAZARD WARNING If any materials are overturned during operation immediately set the power switch to OFF 0 This material should be treated as potentially biohazardous Appropriate clean up and disposal of the material should be observed 1 4 Installation 1 4 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 User s Manual and a serial cable Remove Shipping Screw from Bottom of Instrument This screw prevents movement of the plate transportation mechanism and should ALWAYS be in place during shipping During shipments use the original packaging material or other suitable p
69. nothing 3 4 References 1 Engineering data supplied by Awareness Technology Inc Palm City Florida 1987 1990 2 Data on DRI DYE Check Strips provided by Awareness Technology Inc Palm City Florida 1989 1990 3 5 Dri Dye Check Strips DRI DYE CHECK STRIPS Dri Dye Check Strips offer an easy means of verifying proper calibration and linearity on a routine basis The charts provided allow simple interpretation of results If a strip or plate reader can repeatedly obtain acceptable results with this kit then the instrument demonstrates linearity calibration filter integrity repeatability and lack of stray light Proper use of the Dri Dye Check Strips along with good record keeping will constitute compliance with most quality control and licensing agency requirements for instrument performance verification Dri Dye Check Strips allow the instrument owner to perform testing that is very similar to the Q A Q C testing initially done by the instrument manufacturer Dye absorbance values are determined by a reference instrument that is routinely calibrated with materials traceable to the National Institute of Standards and Technology NIST formerly NBS Dyes are then precisely dispensed into the wells dried and packaged Using predispensed dyes reduces the degree of pipetting precision required to reconstitute the check set strips Since the readers look through the samples from top to bottom volume is proportional t
70. nstrument is turned off Test selections may be stored so that set up time is significantly reduced when the same assay is repeated Calibration curves are also stored The time and date are maintained using this same type of memory Items in non volatile memory may be entered changed or deleted from memory by the operator following the instructions in this section 2 3 1 Storing a Test User tests are stored in the test menu by number 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 identify your numeric entries A sample format for this log can be found in the appendices of this manual Photocopies of that format can be made as new log sheets are needed Each time you store a test the instrument will assign the next available test number The instrument will record the date and time that each test was stored or last modified Remember to update your log The STORE key is used to save a test in the menu Any time after you have made your general selections and read the plate containing the standards but before either turning the instrument off or canceling the mode you may press the STORE key to store a test When the STORE key is pressed the display will ask the question NAME THE TEST Y N To store a name with the test press the YES key A string o
71. ntarily before reading it is correcting for any slight movement of the plate carrier which may have occurred during the normal loading and unloading of plates If you are reading microstrips in trays it is very important that the strips are well seated down into the trays Otherwise they may obstruct plate transportation If for any reason the plate carrier can not advance the display will show MECHANISM ERROR AT PS W and the printer will print an error message as the mode is cancelled The plate will return to home position Remove the plate from the carrier Push the strips down into it Turn the instrument off and then back on again The full range of mechanical motion required to read a plate is tested as part of the Self Check Function A periodic check done by pressing the SelfCk key is recommended 2 4 9 Monochromatic and Offset Absorbance This instrument requires two filter selections the operating filter and a differential filter which may be selected as 0 to read with no differential 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 for which the chromophore being assayed exhibits substantial absorbance A monochromatic option is available for use in scanning the filters independently To read
72. ny times as desired until either an acceptable curve is obtained or the mode is cancelled To read and calculate specimens answer NO to the question EDIT WELLS Y N The remainder of the plate will be read calculated and printed To unload a plate simply lift the plate straight up The instrument will display LOAD NEXT PLATE READ To continue reading in the Point To Point Mode load the next plate and press the READ key Only the first plate must contain calibrator materials If a calibrator has an absorbance reading greater than 3 0 A the printer will print gt 3 00 for the absorbance reading and the concentration will be calculated and printed The test mode will continue however it is not advisable to use such a highly absorbing material as a reference If a sample has an absorbance reading greater than 3 0 A the printer will also print gt 3 00 for the absorbance reading and the concentration will be calculated and printed Press the STOP key any time after the test has begun to read the second strip third strip in the A H direction if you want to stop the reading without quitting the mode 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 and return the plate to the home position 2 2 6 Polynomial Mode POLY The Polynomial Mode operates similarly to the Point to point mode
73. o further facilitate testing Pre programmed Modes The basic calculations are permanently stored in memory and include several single and multi point equations Provisions are made in certain cases for reading specimens in duplicate and or using the mean reading in calculations Each calculation mode is described in detail in section 2 2 Calculation Programs These modes are keyboard selectable and self prompting to reduce error and simplify operation The following general purpose modes are offered absorbance mode single calibrator mode cutoff mode absorbance multi point mode point to point mode and best fit determinations for linear and quadratic functions regression and polynomial modes Convenience Features Convenience features include the ability to indicate the locations and outcomes of positive negative and low positive controls via the keyboard the ability to enter positive and negative cutoffs for automatic interpretations options for automatic blanking the ability to end reading at a user designated well and the ability to plot and edit curves in the multi point calculation modes A convenient built in mixer is also available to provide plate agitation for a timed interval A Self Check key offers automatic function testing to facilitate daily instrument QC requirements and troubleshooting Instructions for the use of each of these features are provided in this manual User programmable Memory User programmable memo
74. o 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 Simply stated the system is self correcting for random pipetting errors up to 10 The charts provided in this kit are designed to replace the normal calculations with easy to visualize built in acceptance ranges 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 3 6 Sample Printouts STAT FAX 2100 W 6 FILTER VISIBLE 03 09 98 15 26 23 READ MODE 1 to 12 ABSORBANCE MODE 12 PAGE 1 03 14 98 08 53 12 LOT NUMBER EXP DATE USER WAVELENGTHS 450NM 630NM BLANK MUST BE WELL 1 1 2 3 4 5 6 7 8 9 10 11 12 1A 0 012 0 455 0 228 0 223 0 457 0 431 0 848 0 920 1 842 1 853 1 853 0 000 BLANK 1B 0 001 0 454 0 221 0 224 0 458 0 462 0 917 0 925 1 877 1 805 1 864 0 001 lC 0 002 0 458 0 221 0 221 0 455 0 449 0 922 0 917 1 868 1 851 1 858 0 001 LD 0 001 0 461 0 223 0 228 0 455 0 459 0 920 0 923 1 861 1 816 1 797 9 9001 lE 0 002 0 459 0 226 0 222 0 455 0 445 0 923 0 894 1 833 1 801 1 717 0 003 1F 0 001 0 452 0 218 0 224 0 461 0 412 0 916 0 920 1 832 1 781 1 689 0 000 iG 0 001 6 456 0 225 0 225 0 464 0 451 0 926 0 915 1 829 1 772 1 699 0 000 IH 0 000 0 456 0 223 0 219 0 449 0 444 0 808 0 940 1 920 1 912 1 881 0 003 TEST ENDED READ MODE A to H CALIBRATOR MODE 8 PAGE 1 03
75. oncentration data x are linear To select this option press YES Otherwise press NO to see the next option YzLn 1000 ABS X CONC This is used when the natural log of the absorbance is plotted against the concentration Resulting concentrations will be the same no matter what base is used In or log however slopes and intercepts will vary The absorbance values are multiplied by 1000 before taking the logs Press YES for this format otherwise press NO and see Y ABS XzLn CONC displayed This is a log linear option Use the YES key to select this If NO is pressed then the log log option will be displayed as Y Ln 1000 ABS X Ln CONC If NO is pressed then the logit log option will be displayed as Y Logit Abs Xz Log Conc Ifthe NO key is pressed the 4 options are cycled again After the axes are formatted the instrument asks whether or not there will be a blank Then the number of the calibrators the units and the value of the calibrators will be requested It will be necessary to enter the values in the same order that the materials are pipetted for accurate pairing Unlike the polynomial mode the Regression mode may be used for both positive and negative slopes When using a format which calculates the In of the concentration do not use 0 0 for the concentration since In O is not defined The smallest number for which this instrument can calculate an accurate In is 0 5 Likewise when using In of 1000 Abs the
76. ot Matrix press YES Select NO and the display will return to the first printer selection prompt After the printer type is selected the display will show Select paper type Letter Press YES for Letter size paper 8 12 x 11 Select NO and the display will show Select paper type A4 Press YES for A4 size paper 210mm x 297mm Select NO and the display will return to the first paper selection prompt After selecting the printer configuration the display will return to the main prompt Note that the default settings are Dot Matrix with Letter size paper Operation To view data such as calibrator results or curve plots or to print a partial page press the PAPER key The HP printer will print data stored in its memory the Canon will expel the partially printed page and load the next sheet Subsequent entries and results will be printed on the next sheet Note that the instrument does not reset its page number count each time the PAPER key is pressed 1 5 Check out Procedure After installation perform the following instrument checkout procedure If any portion of this procedure indicates improper function do not use the instrument Contact your dealer to arrange for assistance Ensure that the shipping screw has been removed Press the self check key labeled SelfCk The instrument will automatically check the intensity of the lamp output the rotation of the filter wheel the X Y motion of the plate carrie
77. ple ID column indicating that this well contained calibrator material In the event that calibrators are read in duplicate well 3 will also be labeled as a calibrator Controls will also be identified in this column In the interpretation column look for data relating to cutoffs and control outcomes To unload a plate wait for the transport mechanism to come to a stop and then lift the plate straight up The display will show LOAD NEXT PLATE READ To continue reading in the Calibration mode load the next plate and press the READ key only the first plate must have the blank and calibrator materials If a calibrator has an absorbance reading greater than 3 0 A the printer will print gt 3 00 for the absorbance reading and the concentration will be calculated and printed The test mode will continue however it is not advisable to use such a highly absorbing material as a reference If a sample has an absorbance reading greater than 3 0 A the printer will also print gt 3 00 for the absorbance reading and the concentration will be calculated and printed Again it is not advisable to use calculations made from absorbance readings above the 3 00 Abs level If a concentration is too great to print in the concentration field the message gt 10 7 will be printed for that result Press the STOP key any time after the test has begun to read the second strip third strip in the A H direction if you want to stop the
78. r the alphanumeric display and the printer When you press the SelfCk key the instrument will display SYSTEM DIAGNOSTICS Remove Plate amp ENTER After you press ENTER it begins a 45 second lamp warm up You can observe the countdown on the display LAMP WARMUP XXX SECS where XXX represents seconds remaining Listen for a double beep when the countdown is completed The instrument will check the lamp intensity at this time and display the results of the check using one of these messages LAMP OUTPUT OK or LAMP OUTPUT LOW Then the instrument will check the positioning of each filter in the rotating filter wheel and display the outcome using one of these messages PHOTOMETER OPERATION OK or FILT XXX VOLTAGE IS LOW where XXX identifies the wavelength that did not pass the test Next the plate carrier will exercise its entire range of motion then return to the starting position Watch the display to see PLATE TRANSPORT OKAY or MECHANISM FAILURE When the self check is done the printer will have recorded the results of the tests for lamp output filter selection and plate transportation mechanism The printed message SYSTEMS CHECK OKAY indicates that you are ready to select a mode and begin testing The entire alphanumeric and symbol set of characters will be sent to the printer to test printer function Observe the printout for accurate presentation If errors are detected review the troubleshoo
79. reading without quitting the mode 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 and return the plate to the home position 2 2 3 Cutoff Mode C OFF In the Cutoff Mode X is multiplied by the mean of the negative controls Y is multiplied by the mean of the positive controls and each of these two numbers are added to the FAC to get 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 0 for X 1 for Y and 02 for FAC a To select this mode press the C OFF key The display will then show CUTOFF CONTROL TEST 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 COV X mNC Y mPC FAC Y N where mNC is the mean of the negative controls mPC is the mean of the positive controls and C O is the cutoff absorbance 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 9 Monochromatic and Offset Absorbance for instructions Then the instrument will give you the choice for reverse cutoff The display will show REVERSE COV Y N If you press NO you
80. rial printer will provide a full detailed report of all selections made The printout also shows plate row and well numbers locations of standards blanks and controls absorbance readings mean absorbances when duplicates are selected concentration results and all other optional interpretation labels and calculations Concentration values user test numbers end marks certain flags the labels for positive specimens and for controls that are out of range and other significant messages are printed in bold type for convenience In the absorbance mode the absorbance values are printed in either an 8 line by 12 column format like a 12 well strip microplate or in a 12 line by 8 column format for 8 well strip plates In all other modes there is one line printed for each well The paper may be advanced at any time by pressing the Paper key Each time the key is pressed a carriage return will be sent to the printer This key is used to allow extra spacing between data as required by the operator Test 101 Test Form Feed On Off Selecting Test 101 will toggle the instrument between printing all tests consecutively on the paper and sending a form feed at the beginning of each test to begin each test at the top of the page When the instrument is turned on the status Form Feed On or Form Feed Off will be printed When you turn the instrument power on you must start at the top of the page Do not advance the paper manually but take the pr
81. rotective foam and remember to install the shipping screw NOTE Retain the original packing material and shipping screw 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 A diagram of the rear panel can be found in Section 1 6 Parts and Controls 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 cor
82. ry allows the operator to store test protocols in a numbered test menu Thereafter these tests may be readily recalled for later use with minimal set up Standard curves are also stored in this memory Test protocols remain stored until either changed or deleted by the user Instructions for using this memory are given in section 2 3 5 Test Menu Besides quick accurate and reproducible results this instrument offers versatility economy and easy maintenance free operation A stable factory calibrated durable design and a timed lamp saving feature further assure the reliability of the Stat Fax 2100 microplate reader 1 1 3 Principles of Operation The plate carrier precisely positions each well into the optical path for reading Light energy from an overhead lamp is focused by an integral 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 operating and differential wavelengths Using bichromatic differential absorbance values corrects for optical imperfections in the plastic wells and removes the effects of meniscus and turbidity A photodetector converts transmitted light energy into electrical signals which are amplified and interpreted A single optical system reads each well one by one thus assuring identical optical conditions and providing an economical and low maintenance design
83. s the instrument from reading or mixing and returns the plate to its home position READ Initiates plate positioning and reading There will be a 45 second delay for lamp warm up if this key is pressed when the lamp is off TO PRINT THE ENTIRE USER MENU SELECT TEST 99 AND PRESS ENTER TO CLEAR THE ENTIRE USER MENU SELECT TEST 183 AND PRESS ENTER 1 7 Specifications Photometric Linear Measurement Range 0 00 to 3 0 Absorbance Units A Photometric Accuracy 1 of the reading 0 01 A from 0 to 1 5 A 2 of the reading 0 01 A from 1 5 to 3 0 A SEI Drift of no more than 0 005 A in 8 hours Warm up tle iiie e perdre rh ctn kana 45 seconds built in Eight SOUNCE cf atest as0511k554 4514 sayey cee lana Tungsten Lamp Standard Wavelengihe 2100 405 450 492 and 630nm 2100 Six Filter UV 405 450 492 630 545 and 340 nm 2100 Six Filter VIS 405 450 492 630 600 and 545 nm Substitute filters from 340 nm 700 nm available on special order Type Of T r i uy u u u k rikn n Multiple cavity sealed interference 10 nm half bandpass typical Vesse Liki mi nak sika bar dar be HEN Standard 96 well plates round or flat bottom wells also accepts strip trays of standard size 8x12 configuration Electronic and Software Microprocessor ianen Z80A Speed dd oe k n in bane d Reads calculates and prints results
84. selected if you chose no differential the Offset Absorbance questions will follow see section 2 4 9 Monochromatic and Offset Absorbance for instructions No blank is used in the Polynomial Mode The reader then asks for the number of calibrators to be used Up to 7 may be used if read singly in either 8 well or 12 well format or if read in duplicate in the 8 well format The entire calibration curve must be contained in 12 wells for the 12 well format i e 6 duplicate calibrators In any case at least 3 calibrators must be used After typing the number of calibrators press the ENTER key The display then prompts you to enter your desired unit code with Select units 0 13 see section 2 1 6 Selecting Units for instructions The instrument will then ask you to enter the concentration values of each standard one by one You may read your standards in any order although the values must be entered in the same order that they will be read and duplicates must be in consecutive wells The instrument can accept calibrator values up to 7 digits and calibrators less than 1000 can accept 2 decimal places If 2 decimal places are desired for calibrators or concentration values the first calibrator must have a 2 decimal place value assigned The display will ask DUPLICATE CALIBRTRS Y N Use the YES or NO keys to answer Then the display will ask DUPLICATE SAMPLES Y N Again answer with YES or NO If duplicates are selected t
85. sier than lower readings Be sure you are operating within the acceptable range of the instrument For best results read dilutions of very dark samples and choose a blank lt 0 4A f Check that the plate fits snugly into the plate carrier The Stat Fax 2100 is designed to accept any of the commonly available standard sized plates If plates are of slightly smaller dimensions they may not be usable 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 instrument to fail or crash 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 printer fails to print Solution Consult the manual for the printer to be certain that the dip switches are set to accept output from the reader Refer to section 1 4 2 Printer Requirements for information concerning the printer If only one setting is wrong the printer will either print nonsense characters or
86. sk DUPLICATE SAMPLES Y N Again answer by pressing either YES or NO If duplicates are selected this will be indicated on the printout The instrument will then prompt for the cutoff options Positive gt and Negative lt Refer to section 2 1 9 Selecting Cutoffs for instructions Finally you will see LOAD NEXT PLATE READ You may locate controls and set their ranges at this time following the instructions in section 2 1 8 Selecting Control Options You may use the End function at this time to read only part of a plate by following the instructions in the section 2 4 3 End Place the first plate into the holder so that the blank well A 1 is at the right rear When the plate is in place press the READ key If the lamp is off it will turn on and begin to warm up as a built in 45 second countdown is displayed The countdown will end with an audible signal indicating that the instrument is ready The instrument will automatically transport the samples through the optical system and back to the home position Readings will be displayed as plate row well absorbance reading Results are printed after each row is read two rows in the A H direction The calculated results will be printed out with one line per well Blank will appear beside the first well number in the sample ID column indicating that its absorbance is subtracted from subsequent readings Well 2 will be labeled CALIBRATOR 1 in the sam
87. strument will prompt for an additional quality control value This is a check of the ratio between the means of the positive and negative controls to assure adequate distinction When you see the prompt mP mN must be gt enter the lowest acceptable ratio for the mean of the positive controls to 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 the instrument will display LOAD NEXT PLATE amp READ You may use the End function at this time to read only part of a plate by following the instructions in section 2 4 3 End Load the first plate and press the READ key The instrument will then begin to read the plate and print the results labeling the controls as Neg Control or Pos Control Press the STOP key any time after the test has begun to read the second strip third strip in the A H direction if you want to stop the reading without quitting the mode 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 and return the plate to the home position b CUTOFF CONTROL TEST After you select the cutoff control test filter selection is prompted In this test instead of using the means of the negative and positive controls to determine the cutoff controls labeled COV Controls are
88. t the pre programmed general purpose calculation modes These modes are initiated by keyboard selection whenever the instrument is not asking for a number yes or no or for a filter selection If the instrument is seeking numeric input and you wish to cancel that request in order to select a new mode press the CLEAR key twice and then select the desired mode upper function used to selectthe mode SAMPLEKEY ABS 1 lower function used to designate numberone only when the instrumentis requesting anumeric value The following key designations are used to identify the pre programmed general purpose calculation modes ABS Absorbance Mode STND Single Calibrator Mode C OFF Cutoff Modes ABS Percent Absorbance Multi Point PGM Point to Point Mode POLY Best Fit Polynomial Function REGR Best Fit Linear Function The other upper functions on the numeric key set are these CNTRL Indicates the well locations of and criteria for controls END Designates the last well to be read if desired BLNK 2 Blanks on the first well of the next plate in Absorbance Mode The numeric set also includes these keys Lamp Turns the lamp on and off This serves to extend lamp life Paper Sends a carriage return to the printer Clear If pressed once before using the ENTER key the Clear key removes a keyboard entry allowing for immediate correction of typing errors If pressed twice the Clear key clears the mode of operation ENTE
89. th 12 wells in each row 1 12 Whenever the plate is loaded into the Stat Fax 2100 with well A 1 at the right rear position these keyboard designations may be used In addition to locating wells the numeric keys are used to input numeric information such as standard values number of standards number of seconds etc They are also used to designate filter choices as follows Four Filter Model Key 1 405nm Key 2 450nm Key 3 492nm Key 4 630nm and Key 0 no differential filter Six Filter UV Model Key 1 405nm Key 2 450nm Key 3 492nm Key 4 630nm Key 5 545nm Key 6 340nm and Key 0 no differential filter Six Filter VIS Model Key 1 405nm Key 2 450nm Key 3 492nm Key 4 630nm ABS STNO C OFF TEST STORE EDIT DEL ves CUCC ang a JC 8 p FABS PGM POLY TIME 8x12 6 pas E F 6 H REGR CNTRL END Ap SelfCk Mix Stat Fax 2100 2 JL 8 U9 gen TA EAER C zero decimal point Key 5 600nm Key 6 545nm and Key 0 no differential filter Most of the keys serve several functions Key function is determined by the question asked in the display Key number 1 for example will serve as a number 1 whenever the instrument is asking for numeric input It will select the 405nm filter if a filter choice is being requested It will answer YES if a Yes or No question is being asked Otherwise it will select the Absorbance Mode The upper functions on the first 7 numeric keys represen
90. th 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 name unit should be installed on a sturdy level surface capable of supporting the instrument s weight 25 Ibs 11 4 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 Use Proper Fuse Use only the fuse type and rating specified by the manufacturer for this instrument Use of a 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 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 C
91. that the instrument is ready The instrument will automatically transport the samples through the optical system and back out again Readings will be displayed as plate row well absorbance reading Results are printed after each row is read two rows in the A H direction in either an 8 X 12 ora 12 X 8 matrix pattern depending upon the selected plate format A plate is completely read and printed in about 2 minutes in this mode If the operator has selected to blank by pressing the blank key the instrument will show this by printing BLANK MUST BE WELL 1 before the column headings The absorbance value of the blanked well well A 1 will be subtracted from the subsequent readings To unload a plate simply lift the plate straight up The display will indicate LOAD NEXT PLATE READ To continue reading in the absorbance mode load the next plate and press the READ key Press the STOP key any time after the test has begun to read the second strip third strip in the A H direction if you want to stop the reading without quitting the mode 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 and return the plate to the home position 2 2 2 Single Calibrator Mode STND When you select the STND key the printer prints CALIBRATOR MODE 8 or 12 to indicate the selected plate format PAGE 1 in
92. the 3 calibrators are read in duplicate For calculating the standard curve n 3 nz6 If one well of a pair is deleted during an editing cycle then the other well will represent the mean point and n 3 nz2 2 1 8 Selecting Control Options There are two optional features that facilitate the location and analysis of positive negative and or low positive control outcomes First the locations of up to 3 total controls will be indicated on the printout if programmed by the operator Additionally the operator may enter positive and low positive control acceptance ranges If so the instrument will print the upper and lower limits then automatically compare the resulting concentrations of located controls with this range Controls which do not fall within the designated range are flagged in bold face type Control locations and acceptance ranges are entered using the CNTRL key Control locations may be designated in any mode except the absorbance and cutoff modes when LOAD NEXT PLATE READ is being displayed The location of only one well of a duplicate pair is needed to identify a control being read in duplicate Control locations must be designated in order to make automatic comparisons to user entered acceptance ranges The control ranges and the locations of the controls are saved in non volatile memory when tests are stored in the user test menu After pressing the CNTRL key you will see Select control type Pos C Y N To
93. ting Cutoffs Samples may also be labeled as Positive Equivocal or Negative according to operator entered criteria The criteria used can be 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 Positive is printed in bold type in the column entitled Interpretation All other samples are labeled as Negative in this same column 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 Equivocal Here is how to make cutoff selections in all modes other than Absorbance Mode and Cutoff Mode After choosing the mode filters calibrators and replicates the instrument will display POSITIVE gt If you do not want any cutoffs press the ENTER key to move on Otherwise type in the upper cutoff and then press the ENTER key Next the instrument will display NEGATIVE 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 Your cutoff s will be printed Check to see that they are correct before proceeding If you choose a positive cutoff an additional calculation will automatically be perform
94. ting guide and contact your dealer for assistance The message FILTER LABELS RESET or RUN TEST 248 TO RESET FILTERS occurs when the memory of the instrument is affected in such a way as to lose the filter labels stored in RAM If this occurs see the Flags and Error Messages section of this manual section 2 4 5 for instructions 1 6 Parts and Controls The following labeled sketches serve to clarify the nomenclature which is used in this manual to describe parts and controls of the Stat Fax 2100 More details on the operation of each feature are provided in section 2 Operating Procedures 1 6 1 Parts of the Instrument A Cover B Base C Rear panel D Deck E Microplate in Plate Holder in home position F Alphanumeric display A G Keyboard H Right rear well A 1 Hatch Cover J Parallel port K Power switch L Power cord set M Ground pin alternately the instrument may be supplied with a standard P L J K N O Euro plug 2 round pins for European clients p emp R N Voltage selec switch O Serial output connector P Vent holes C Q Serial Cable Female 9 DB for reader Male 25 pin DB for MS ERIAL printer EM Q D 1 6 2 Keyboard Functions The keyboard is divided into two sets of keys The numeric keys are located in the left most set and the alpha characters A H are located in the right most set These keys are used to indicate well locations Standard microplates are labeled as 8 rows A H wi
95. tive 1A Positive iB Negative 1g Negative 1D Fositive 1E Fositive lr Negative iG Negative lH RR R3 ho Po NN PO KK PA CUTOFF CONTROL TEST 8 PAGE LOT NUMBER WAVELENGTHS 492NM 630NM BLANK MUST BE WELL 1 Blank must be lt EXP DATE 0 100 Correction Factor 0 500 COV 0 50 mCCs POS gt 1 10COV NEG 0 90COV of Neg Controls 1 Neg C must be lt 0 300 of COV Controls 3 cov C must be gt 0 360 of Pos Controls 1 Pos C must be gt 0 500 mP mN must be gt 2 006 Last Well is at 1LH 02 PLTE WELL SAMPLE ID ABS 1A 1 Blank 0 033 1B 1 Neg Control 0 086 Mean of 1 NCs 0 086 1c 1 Cutoff Ctrl 0 522 1D 1 Cutoff Ctrl_ 0 529 IE 1 Cutoff Ctrl 0 515 Mean of 3 CCs 0 522 1F 1 Pos Control 0 768 Mean of 1 PCs 0 768 C O ABS 0 261 1G l1 0 008 1H 1 2 0 271 1A 2 3 0 005 1B 2 4 0 406 1c 2 5 0 151 1D 2 6 0 071 1E 2 7 0 123 1F 2 8 0 226 1G 2 9 0 404 1H 2 10 0 007 END OF RUN TEST ENDED Abs COV Po OO OO OO Ca OC 030 039 013 554 578 2 2 472 865 546 026 03 09 98 15 40 41 USER INTERPRET lA 1 1B i lC 1 lD 1 1E 1 lF i Negative IG 1 Equivocal 1H 1 Negative lA 2 Positive 1B 2 Negative IC 2 Negative 1D 2 Negative lE 2 Negative LF 2 Positive 16 2 Negative lH 2 ABSORBANCE MULTI PT 8 PAGE 1 03 09 98 LOT NUMBER EXP DATE USER WAVELENGTHS 492NM 630NM BLANK MUST BE WELL 1 CALIBRTR 1
96. u of the user tests This menu will list the test number the test name if any the mode the test uses and the date and time last modified 2 3 6 Multi Test Format Aux1 The multi test mode is not actually a test it is used for running a multiple number of stored tests in one plate 2 3 or 6 tests in the A H direction or 2 or 4 tests in the 1 12 direction The tests must be set up individually prior to selecting the Aux1 key e you must store any necessary calibrators etc that you wish to use ahead of time Follow these points carefully 1 Ensure that all tests are set up in the same read direction 8 way or 12 way If a test has been set up with an opposing read direction to the one chosen when the Multi Test Format is run the mechanism will jam while attempting to run the incorrectly formatted test the error message MECHANISM ERROR will be printed and the test will be ended 2 Ensure that all tests are of the same mode type If the tests are of different mode types e g one is a single calibrator mode and another is a cutoff mode the test will not run properly 3 Be certain that all the controls are entered in the first two strips The locations of the controls and calibrators will be automatically transposed to the appropriate section of the plate 4 When you have entered all your controls and duplicate options press the STORE key then follow the directions under 2 3 1 Storing a Test You can then press t
97. ument will proceed to read and calculate the samples If YES is pressed you will see DELETE WELL displayed The first well read is well 1 the second well read is 2 and so on Type in the well number that you wish to delete and press ENTER Again you will see DELETE WELL displayed If you wish to delete another well type in its well number and press ENTER You may delete as many as one from each pair but you may not delete an entire point When no more deletions are desired press ENTER again The standard curve will be recalculated showing an X beside the deleted well s When a duplicate absorbance is deleted the remaining well will be used as the value for that standard point Again the operator will have an opportunity to plot and to edit This may be repeated as many times as desired until either an acceptable curve is obtained or the mode is cancelled To read and calculate specimens answer NO to the question EDIT WELLS Y N The remainder of the plate will be read calculated and printed To unload a plate simply lift the plate straight up The instrument will display LOAD NEXT PLATE amp READ To continue reading in the Poly Mode load the next plate and press the READ key Only the first plate requires the calibrator materials In the event that the absorbance reading of a calibrator is greater than 3 0 A the printer will indicate gt 3 00 in the absorbance field The test mode will not be can
98. used to do so The positive and negative controls are used for QC criteria After filter selection the instrument will prompt BLANK Y N In this mode the photometer can be blanked on air by pressing NO Alternately the instrument can be blanked on the material in well A 1 by pressing YES If yes the instrument will display Blank must be 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 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 will then prompt Correction Factor This Correction Factor is multiplied by the mean of the COV Controls to result in the actual cutoff value Pressing ENTER will bypass this option setting a Correction Factor equal to 1 The instrument then prompts EQUIVOCAL 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 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 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 Pos
99. will be used by displaying KEY OF CALS ENTER Up to 7 may be used if read singly in either 8 well or 12 well format or if read in duplicate in the 8 well format The entire calibration curve including any blank must be contained in 12 wells for the 12 well format i e 6 duplicate calibrators without a blank or 5 with a blank Type the number of calibrators then press the ENTER key The display then prompts you to enter your desired unit code with Select units 0 13 see section 2 1 6 Selecting Units for instructions Next the instrument will ask you to enter the first calibrator value by displaying KEY VAL C1 ENTER Type the concentration value assigned to your first calibrator material Then press the ENTER key The instrument will then ask you to enter the second calibrator value by displaying KEY VAL C2 amp ENTER Type the concentration value assigned to your second calibrator material Then press the ENTER key This will continue until all calibrator values have been entered Tn acceptablecurves Then the printer will print ascendingordescending CALBRTR 1 XXXX monotonic CALBRTR 2 XXXX notacceptable CALBRTR 3 XXXX mixed direction non monotonic where XXXX represents the calibrator values you entered The instrument can accept calibrator values up to 7 digits and calibrators less than 1000 can accept 2 decimal places If 2 decimal places are desired for cali
100. will go into the regular cutoff mode where samples with values higher than the cutoff are labeled as positive If you press YES you will go into the reverse cutoff option where the samples with values lower than the cutoff are labeled as positive If you choose this option be careful to follow the lt and gt signs in the prompts for entering cutoffs and ranges since they will be the reverse of those described here 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 must be 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 FAC cutoff factor values Type each of these values followed by the ENTER key After these values are entered into the equation the instrument prompts EQUIVOCAL 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 Negative range enter 1 if you want
101. y Cutoff Modes C OFF key Absorbance Multi Point Mode ABS key Point to Point Mode curve constructed from point to point connection PGM key Best fit by polynomial regression POLY key Best fit by linear regression REGR key O N O oO A CO N Alternately a previously stored test could be recalled from your user test menu at this time Instructions for this are found in section 2 3 Test Menu The pre programmed general purpose calculation mode designations are located above the numbered keys on the keypad When any of these is selected the printer will print the name of the mode that you have selected either 8 or 12 to indicate the plate format the page number of the test Page 1 and the date and the time The display will then indicate your next instruction A brief description of each mode follows For more details see the section 2 2 Calculation Programs In the Absorbance Mode the Stat Fax 2100 reads and prints the monochromatic or bichromatic differential absorbances at the user selected wavelengths Blanking is optional through use of the BLANK key Modes with one calibration point In the Single Calibrator 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 to determine the 0 0 point A factor equal to the concentration of c

Stat Fax® 2100 Operator`s Manual

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Stat Fax&reg; 2100 Operator`s Manual

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Stat Fax® 2100 Operator`s Manual