ABOUT THIS MANUAL lanual is designed to supplement on-screen operating instructions and printed texts. Revised 96TABLE OF CONTENTS 1ON 1. Introduction Introduction (test categories; types of samples analyzed. etc.) 1:2 Available Methods... ce ceccesee ee 12 Some Facts and Figures 12 SECTION 2. Unpacking and Installation Unpacking Carton Contenes 2 Installstion 22 If Using Flow Cell Placing waste twhe into waste container 23 Washing tubing 23 Calibrating flow cell aspiration volume 23 If Using Disposable Cuvettes Use only (type) Slane ree 23 BAYER Semi-micto Cuventes ......... 23 BAYER micro Cuvettes 23 EDP? Personal Computer Interfaci a) 24 Turning the Power OfF . 24 Turning the Power On (Anytime sfter Installation) 24 Updating Software Ss : 24 SECTION 3, RA-SO Chemistry Analyzer ~ Deseription Front Panel eee 34 Back Panel 22... eee eee ei 33 Lett Side Panel 34 Audible Tones oes HEINE, corcicvic este esn 34 SECTION 4. Basic Set Up Options - Select Key Operations Viewing Factory Settings for Basic Set Up Options 40 Accept Factory Settings? - : 42 How to Change Settings for Busic Set Up Options. 3 43 Locking Only Test Programs OF Your Choice (Example #1) eto 44 Locking All Test Programs (Example #2) ..... e = 46 Printing ‘Test Parameters At Test Selection (Example #3)... . 47 Select Key Operations ~ Additional Functions . coe 48 Catibrating Flow Cell Volume eee cee eee coe 4B Initializing Data Memory ......... eee 5 48 Print Test Menu 48 Print Number of Samples Analyzed. . 48 Changing the Password (Example #4) . re 49SECTION S. Program Key Operations ‘The Program Key Allows You To’ Checking the Status of a Program... s1 How to Check Program Status (Example #5) . 52 (Changing Program Parameters that do not Affect Algorithm . 53 Programming or Re-prograniming Test ‘Types of Algorithms : s4 Bichromatic Measurement x 54 Program Parameters for Each Algorithm 55 How to Program or Re-program a Test (Example #6)... 56 Deleting an Unlocked Test Program... RUNG Oy fareneney ores 5.10 Deleting Changes to a Locked Test Program su SECTION 6. Absorbance Key Operations How to Measure the Absorbance (Flow Cell Active ~ SERA-PAK Status) Example #7 ...... 6.1 SECTION 7. QC Key Operations Use the QC key to 7 Labeling and Storing the First QC Result... Bina oarruios eae 2.2 Labeling and Storing QC Results (not the frst) eee ee eeeeeee 73 Printing Quality Control Charts, Deleting QC Memory, Printing QC Results. 74 SECTION 8. Analyzing Samples Sarfiple Preparation . : 81 Sample Analysis nee 8.1 Using the Blank Key (Flow Cell Active) . 82 Using the Calibrate Key (Flow Celll Active) epee . 83 Using the Analyze Key (Plow Cell Active) . a 84 Using the Clear Key =... eee 85 Using the Decimal Point Key .... 83 General Tips .-... Bere Reg era era aetna et re re one 83 SECTION 9. Troubleshooting, Error and Warning Displays. ot Revised 12/90SECTION 10. Instrument Care, Maintenance and Minor eg Instrument Care : x Riera theney 10.1 Maintenance ‘Cleaning Exterior of Instrument and Flow Cell Chamber (Disinfection of Exterion) 10.1 Cleaning Cuvette Well... eee cece paki 10.2 Flow Cell seo 10.2 Calibration of Flow Cell Aspiration Volume 0... .0c00sce0 10.4 Minor Repa Replacing Lamp ...... e peeieeseermice: 103 Replacing Fuses 10.4 Selecting Operating Voltage a B stvncen 105 Replacing Printer Paper obs Tateralioe ECD ees = 106 Replacing Flow Cell Tubing Flow Cell cee 107 Replacing Aspiration Tube and Suction Tube a LrooenO\S Replacing Flow Cell eSB gain ae sone: 10.8 SECTION Ml Service Information How to Report the Problem .....+ es na Replacement Parts und Accessories shiatss 11.2 SECTION 12, Specifications, Safety Notes, Warranty 00000... Parra iil APPENDIX. Test Mento... 0-0 App 1.2 iv Revised 12/90INTRODUCTIONINTRODUCTION The RA-50 is a programmable Chemistry Analyzer capable of providing quantitative results for up to 106 different test in the following categories: * therapeutic drugs © plana promine + hormones: + electrolytes + substrates * coagulation The RA-50 Chemistry System consists af: + RA-SO Chemistry Analyzer with Phug:in Pro ram Module BAYER DIAGNOSTICS Reagents The RA-50 Chemistry System analyzes: plasm + whole blood (hemoglobin) unne Available methods are: * Endpoint + Fixed time + Kinetic Multi-calibration + Bichromatic + Absorbance Some Facts and Features © use of flow cell or disposable cuvettes © display prompts to easily guide you through test procedures * printed! HELP texts available by pressing Help, key rated quillity control program includes printed contro! chart * your choice of text in either English, German, French, ltalian snd Spanish languages © updatable software vi program module #2 keyboard tests: 64 available by entering test code number exe able plug-in Revised 591NOLLV FIVISNE ANY DNINDVAND. UNPACKING AND INSTALLATIONUNPACKING AND INSTALLATION UNPACKING Use extreme care when unpacking and handling the RA-50 Chemistry Analyzer The instrument ‘contains sensitive electronic and optical parts. NOTE: Affer removing instrument from carton, lift flow cell chamber cover (found on right front panel, above yellow clamp) and remove foam packing material. CARTON CONTENTS * RA-S0 Chemistry Analyzer ~ Product Code No. 7424 (shipped with printer paper and re~ movable program module already installed) * Power Cond * Dust Cover * Operating Manual Missing Items? Damaged Items? Contact your nearest RA-50 Representative Revised 12/90STALLATION 1. Place the Instrument: * on a firm, Jevel, vibration free surface away from microwaves emitted by therapeutic ‘equipment used in the same roon * away from areas of direct heat, direct sun light or other direct fight sources closer than Tmeter; * at least 30 em from wall to allow for proper ventilation (and placement of waste con- tuiner, if using flow cell) ay [rom excessive dust or other particu late matter CAUTION: Do not sinoke near instrument. Smoke may leave a film on the optical sur- faces within the instrument. This film may affect optical transmission qualities. WARNING: Set the power switch to OFF. (The power switch is set to OFF when the ted ‘O° on switch is displayed.) 3. Check to make sure the (yellow) program module (on the left side of the instrument) is securely plugged in. CAUTION: The program module ean be damaged if inserted when the power is ON 4. Check to verify printer paper is installed. ‘* Instructions for installing printer paper are found in Section 10. Lack of printing paper ‘will cause premature deterioration of the printer. Do not operate the instrument with ‘ut printer paper unless the printer is turned. OFF, 5. WARNING: Make sure the correct voltage for your location is indicated on the voltage selector on the back panel of the instrument. * The RA-SO instrument is factory set to. operate on 220 AC If your location requires a different voltage (JO0V, 120V or 24O0V) reter to Section 10. 6. Connect the appropriate end of the provided ‘power cord (or an approved power cord, see SECTION 12) 0 the instrument. 7. Plug the remaining end of the power cord into a properly grounded. live, AC electrical outlet: 8, Set the power switch to ON, The software version number is displayed on the first line FASO Vix ‘Data memory . © The instrument automatically checks the primter, data memory, filter whee! and optical system. Upon successful completion of the System check, the following is displayed (about 45 seconds after the power is turned ON). 7 (time) Instrument does not function? Display(s) fail to appear? Contact your nearest RA-50 Representative. Revised 591UNPACKING AND INSTALLATION IF USING FLOW CELL NOTE: The cuvette system is factory set tor flow ccell use and 37°C temperature control, Tempera- ture control may be reset for 25°C or 30°C. In addition, you may easily switch trom flow cell to disposable cuvette use Instructions are found in Section 4. |. Place the waste line tube into a waste container (provided by you). NOTE: As waste enters the container. air must ‘escape, Make sure the hole through which the tube is placed is large enough to allow arto ‘escape trom container. Or. provide a separate hole for the escape of air. 2. Wash the aspiration tubing to remove possible dust or other particulate matter: * Place aspiration tube into about 5 ml of distilled water. + Press the Rinse key until all distilled water is aspirated, + Repeat step 2. twice. Calibrate the flow cell aspiration volume: + Press Select, 5, Enter, * Accurately add 5 mi of distitled water to a test tube. + Insert the aspiration tube into the water until the aspiration tube touches the bottom of the test tube. + Press the Rinse key only until all water is aspirated. CAUTION: Immediately release Rinse key when all water has been aspirated. NOTE: Complete instructions for maintaining the flow cell system are tound in Section 10) Review this section before usimg your instrument IF USING DISPOSABLE CUVETTES Use only: * BAYER Semi-micro Cuvettes (Code No. 7220) + BAYER Micro Cuvettes (Code No. 7221) Why? * They provide for optimum temperature control since the cuvette well was specially designed to fit the shape of these cuvettes * They meet the required specific plastic cuvettes in endpoint deter for using tions. BAYER SEMI-MICRO CUVETTES (Code No. 7220) mix contents by tilting or gentle shaking * locate grooved marking on upper rim: with to groove, place cuvettes into cuvette in the sime direetion each time (allows for optimum results) BAYER MICRO CUVETTES (Code No. 7221) * place cuvettes into cuvette well in the same direction each time (allows for optimum results) + use for coagulation tests (shipped with hid) NOTE. The cuvette system is factory set for flow cell use and 37°C temperdture control, Tempera- be reset for 25°C or 30°C, ing from flow cell to disposable cuvette Instructions are found in Section 4 Revised 3796EDP, PERSONAL COMPUTER INTERFACING ‘The RA-S0 instrument may be interfaced to an EDP System or personal computer, Contact ux for instructions TURNING POWER OFF ‘Turn the power off when the instrament is notin use (no data will be lost) + It takes only about 45 seconds for the instru- ment to be ready-for-use after if is turned ON. ‘+ Turing the power Off when the instrument is not in use prolongs lamp life. TURNING THE POWER ON (Anytime after installation) Ifusing the flow cell: ‘+ Make sure the flow cell is filled with distilled water (not sample or reagent solution) when the power switch is set to ON. Otherwise, the optical system check will fail, resulting in an error message, or erroneous test results may oceur If using disposable cuvettes: *# Make sure no cuvette is in the cuvette well when the power switch is set to ON. ‘Otherwise, the optical system chock will fal, resulting in an error message. or erroneous test results may oceur. UPDATING SOFTWARE Before you install a new program module, make stire all changes made to factory settings ancl individual programs are recorded and available. ‘When you install a new program module, all stored data are: + untouehed if changes inelude only text modlifi- cations, or the addition of other languages + ost for any test when changes affect the ‘measurement algorithm INSTALLING UPDATED SOFTWARE 1, Turn the power off. Unplug the cord from the instrument and power source. WARNING: Do not insert program module if power is ON. This can damage program module. Plug new program modulle into program module receptacle. (It should click into place.) 3. Connect power cord to instrument and power source Turn the power ON, Audible tones sound while the new software is loaded into memory. 4, WAIT until the display shows “Press test key or test code number” (no data is lost). or “Loss of data” (data is lest), IMPORTANT: If the following appears, you ‘must press “1 or “0” to complete installation # IF “1” is pressed, do not interrupt printing. If you interrupt printing, installati be completed; “Loss of data!” to appear Revised 12/90RA-50 CHEMISTRY ANALYZER — DESCRIPTION FRONT PANEL BD pistes ~ shows date, time, error messages, test results, procedural prompts, etc Kaper 42 Test Keys — selects test printed on key Number Keys — selects test code number for a test not available via test key provides numerical input for instru- ‘ment set up, prograin parameters, ete Decimal Point — selects decimal point displays time of coagulation for coagulation tests (PT and P” Asterisk — prints error list Enter ~ confirms selected operations and numerical inputs Clear ~ erases an incorrectly typed number if “Enier™ was not pressed ~ deletes calibration, blank values, analyses (Refer to Section 8) Paperfeed ~ advances the printer paper Rinse ~ initiates flow cell rinsing Revised 96labels and stores the next result as a control result ~ initiates printing of stored quality control data (Refer to Section 7) Absorbance — selects one of seven available wave- lengths for absorbance measurement; initiates absorbance measurement for ‘both flaw cell and disposable cuvette modes (Refer to Section 6) Calibrate ~ initiates analysis of Standard (if using disposable cuvette mode) = allows you to calibrate, then decide whether to retain the old calibration, store the new calibration or stare the average of old and new calibrations (Gf using the flow cell mode) [Refer to Section 8} Blank ~ initiates analysis of Blank (if using disposable cuvette mode) ~ initiates & new test run that uses sample blank values, if using flow ell mode (Refer to Section 8) ~ allows you to analyze a new reagent blank and store its value, if using flow cell mode (Refer to Section 8) Analyze ~ initiates analysis of Sample (if using disposable cuvette mode) — allows you to analyze samples before all sample blanks have been entered for the number of samples selected, if using flow cell mode (Refer to Section 8) Program — indicates program type, enters pro- ‘gram changes, inputs new programs, deletes entire program or just pro- ‘gram changes (Refer to Section 5) Seloet selects basic set up options, restores system to factory settings, etc. (Refer to Section 4) Abort ~ terminates printing in progress = cancels procedure or test in progress Help — prints available “Help” texts Aspiration Tube = carries sample to flow cell for analysis ~ carries distilled water or cleaning/ disinfection solution to flow cell Yellow Clamp — holds the aspiration tube place Aspiration Button ~ pressed to aspirate sample (flow cell mode) Cuvette Well Cover = cavers and protects the cuvette well ~ slides left Flow Cell Chamber Cover = covers and protects cuvette well, flow cell storage chamber and aspiration tubing — lifts up Lamp Cover = protects the area where the lamp is located ‘Thermal Printer ~ prints test results, “Help” texts, QC data, number of samples analyzed, etc. — can be turned off Revised 12/90RA-3S0 CHEMISTRY ANALYZER BACK PANEL RS-232-C Output Connector — accepts the plug for the seria Printer Paper Holder cable © ids printer paper mae Pump Power Cord Connector — provides suction to aspirate liguid and — accepts the plug for connecting the Bree aese power cord to the instrument Waste Tube Power Switeh = tums power ON and OFF one end is connected to pump waste outlet while the other end is placed into ‘ease container (provided by you) Fuse and Voltage Selector Cover ~ covers and protects the area where Suction ‘Tube fuses und voltage selector are logated ‘one end is connected to the pump Suction inlet while the other end is connected to the flow cell * See page 12.2 for interface cable connection as Revised 396LEFT SIDE PANEL BB broeram module Receptacle — holds program module EB Program Module — stores lest specific parameters — exchangeable for easy software update AUDIBLE TONES Long tone = sounds when the instrument is mrned ON. Short beep — sounds when a key is pressed, the aspiration button is pressed, or an error message is displayed ‘Continuous beeps — sounds while updating software HELP TEXTS Some display messages are supplemented with printed “Help” tests, Press Help key to print help text. Revised 3/96BASIC SET UP - SELECT KEYBASIC SET UP OPTIONS - Select Key Operations VIEWING FACTORY SETTINGS FOR BASIC SET UP OPTIONS serviced it. settings marked with an asterisk (*). rt on the next page, are active in your instrument In addition, the number of calibration replicates is factory set to 0, and the uspiration volume factory set to 1000 juL. Instructions for chan aspiration volume, one test at time, a Section 5. Note that some basic set up options, such as DATE/TIME nly one senting choice * Read this chart to determine if factory settings must be changed. Revised 12/90Select Key Basic Set Up Option Factory Setting Other Available Settings Code No. GENERAL Cuveite Type *Flow Cell Disposable Cuvettes Language English German, Spontsn, French, Halian, Time'Date *Central European Portuese Day-Month-Year 5 Normal Range Check +00 4 RS-252-C Serial Port Bavd Rate 9600 110, 180, 300, 600, 1200, 2400, 4800, 9600 6 Parity Check Even, Odd Stop Bits 2 Block Transfer on XON/XOFF Protocol Yes No UNITS: Substrates, Immunoassays, Electrolytes, Conventional sr 10 Eneymes *Conventional st u Coagulation - PT “Quick % See prr Sec R 2 ENZYME Linearity Check ‘on of 20 Sarnple Substrate Srarier *Sabstrote Sample 2 ‘TEMPERATURE sre 25, 0C 30 (ior BAYER DIAGNOSTICS Kinetic Tests, only) PRINTER +on of a — prinrour With oF without program parameters attest selection without with 2 (fortests programmed by you. only) PROGRAM Lock/Valock AML tests are Lock attests: Test Programs unlocked Test specific loek/unlock 50 Accept factory settings? Continue with instructions on page +8 Revised 1/92BASIC SET UP OPTIONS HOW TO CHANGE SETTINGS FOR BASIC SET UP OPTIONS Keys Required: Select, Number Keys, Enter. Password: 4711 (required for test lock/unlock procedure (Code 50) If necessary use: “Clear” to erase incorrectly typed digits before pressing Enter “Select, 6, Enter, Abort” to determine (via Printout) what settings are active in your instru ‘ment for serial port parameters IMPORTANT: Keep a permanent record of all changes made. DISPLAY. WHAT YOU DO 1. Press Select . Type Code Number for the option you desine to change (see previous chart) * Press Enter. ay Follow instructions on display. ‘HELP TEXT IS AVAILABLE At some future time, if you would like to change the setting for an option available via Select key, press Help (after pressing Select.) The following menu is displayed: Now you can select the subject for which you re- quire detailed information, * All options and functions available via Select key are printed with corresponding code ‘numbers. (To terminate printing. press Abort.) * This printout, however, does not indicate option settings active in your instrument. That is, for ‘example, the printout does not indicate whether you have selected 37°C or 25°C, or disposable cuvettes, SI units, ete ‘Therefore, keep a permanent record of all ‘changes made so that you can quickly det. mine the status of your instrument's Basic Set Up Options. Revised 1/92LOCKING ONLY TEST PROGRAMS OF YOUR CHOICE (one at a time). The factory set password is 4711, recommended that your luboratory choose gramming status. Instructions for changing the a-new password to ensure the safety of pro- password are an page 4.9. EXAMPLE #1 The RA-50 System is unlocked. Lock programs for Cholesterol and IgG. DISPLAY WHAT YOU DO Press Test key or SEeee eeieet ‘Test code number Flow cell active (date) (time) RA 60 Contiguration? 2. Locate the Code No. for Programming, lock/ Funetion: 7 unlock in the chart on page 4.2 (or press cieaencn . Help key). ‘Then, press Enter Press $0. Then, press Enter 3. Type 47 ‘Type in a ee (factory set password) feet Eee continued on next page Revised 12/90,BASIC SET UP OPTIONS DISPLAY Type in Password: a7 Press “Enter” Test programming 4: yes, all tests Test Program Please select a Test by entering Code or pressing a Test key Chol programming 0: no tyes hot Test programming is not possible Then: Test Program Please select a Test by entering Code or pressing a Tast key WHAT YOU DO. 4. Press Enter 5. Press 3. Reminder: All tests were unlocked, Pressing *3” allows you to lock tests individually: ‘Those tests you do not individually lock will remain unlocked. (Conversely, if programs were locked, pressing. *3" allows you to unlock tests individually. Those tests you do not individually unlock will remain locked.) 6. Press CHOL. 7. Press. NOTE: The Cholesterol program is now locked. No changes affecting algorithm can be made. However, you can change normal range, aspiration volume, etc, (items that have no effect on algorithm). Such changes are made using “Program” key (refér to Section 5). Reminder: All other programs remain unlocked. 8. Repeat steps #6 and #7 for IgG. 45 Revised 12/90LOCKING ALL TEST PROGRAMS ‘The factory set password is 471 * Iris recommended that your laboratory choose anew password to ensure the safety of pro- ‘gramming status. Instructions for changing the password are on page 4.9. EXAMPLE #2 The RA-S0 System is unlocked. Lock ull test programs, DISPLAY Press Test key or Test code number Flow cell active (date) (time) RIA 50 Configuration? Function: Press number(s); Then, press Enter Type in Password: 2 Press “Enter” Type in Password: a7 Press “Enter” Test programming 1: yes, all tests 10, all tests rest specitic WHAT YOU DO 1. Press Select 2. Locate the Code No. for Programming, lock/unlock in the chart on page 4.2 (or press Help key) Press 50. Then, press Enter, 3. Type 471. (tactory set password) 4. Press Enter, Press 1. Reminder: All tests were unlocked. Pressin; "1" locks all test programs. Revised 12/90 46BASIC SET UP OPTIONS PRINTING PROGRAM PARAMETERS AT TEST SELECTION * only for tests programmed by you (not for factory programmed tests) EXAMPLE #3 DISPLAY WHAT YOU DO Press Test key or Ieee es Test code number Flow cell active (date) (time) RA5O 2. Locate Code No. for Printout (with or without Configuration? rogram parameters) in the chart on page 4.2. Function: eee Press number(: 3. Press 42. ‘Then, press Enter 4. Press Enter. BA S0 Configuestion? Funetion: Then, press Enter 5. Press 1. Print measurement parameters at test selection: 0:no tryes a ison 47 Revised 12/90SELECT KEY OPERATIONS — ADDITIONAL FUNCTIONS In addition to changing settings for Basic Set Up ‘Options, the following chuart shows additional Select key functions. ADDITIONAL FUNCTIONS Calibrate Flow Cell Aspiration Volume Initialize Data memory Ee Race Print Test Menu 40 Print Number of Samples Analyzed ..... 43 ‘Change the Password 31 Correct QC Chart... 8 CALIBRATE FLOW CELL ASPIRATION VOLUME Section 10 ells you when aspiration volume must be calibrated. When calibration is required or desired: * Press Select, 5, Enter:* + Then follow the display prompts *HELP TEXT IS AVAILABLE: The complete procedure for calibrating the aspiration volume is printed. INITIALIZE DATA MEMORY When you initialize data memory: * Settings for Basie Set Up Options, shown in the chart on page 4.2, are reset to factory selection except Program lock/unlock. If test programs are locked, they will remain locked. + All data is deleted (such as blank values, QC data, calibrations) regardless if test programs. are locked or unlocked, * All unlocked test programs are reset to original factory program, or no program staitss, which- ever is the case * Locked test programs are untouched: however changes made (via Program key — refer to Section 5) that do not affect the algorithm such ‘as normal range, aspiration volume, etc. are Teset to factory selection. ‘Toinitialize data memory: + Press Select, 7, Enter? «Then follow the display prompts *HELP TEXT IS AVAILABLE PRINT TEST MENU ‘The printed test menu supplements the 42 tests you see on the keyboard. * Up to 64 more tests are available via code umber entry. ‘What ‘ests Appear On Printout? Up to 54 tests (available via Code No), plus {en unassigned tests, appear on printout (see appendix 1) * Iftest programs are locked: ~ only programmed tests (and unassigned tests #1-10) ure shown on printout ¢ If test programs are unlocked: ~ all available code number tests (and unas- signed tests #1-10) ure shown on printout ~ an asterisk (*) marks each programmed test To print test menu: * Press Select, 40, Enter* To stop printing, press Abort “HELP TEXT AVAILABLE The test menu is also printed by pressing Help While “Press Test key or Test code number” is displayed. NOTES: All keyboard tests are programmed for BAYER DIAGNOSTICS Reagents except, Chlorine (Cl) (which is not pro- rammed). ‘The first ten programs (see printout) are Unassigned and are reserved for programs of your choive. PRINT NUMBER OF SAMPLES ANALYZED + Press Select, 43, Enter. ‘The test name and number of samples analyzed {not including marked QC samples) are printed. Revised 1/92 48BASIC SET UP OPTIONS CHANGING THE PASSWORD The password must consist of up to 4 digits. IMPORTANT. If you change the factory set password, and the new password is forgotten or Jost, functions requiring password entry cannot be accessed. * To regain access to such functions, the instru- ment must be returned to us for servicing. Dur- ing servicing, the entire instrument memory is deleted and the factory set password is restored. CAUTION: Make sure you save new pass- word in a safe place. EXAMPLE #4 ‘The existing password is 4711, (Change password to S711. DISPLAY Press Test key or Test code number (date) (time) RA 50 Configuration? Function? Press number(s) Then press “Enter” RA 50 Configuration? Function 51 Press number(s) Then press “Enter” ‘Type in password: 2 Press “Enter” WHAT YOU DO 1. Press Select. 3. Press Enter. + ‘Type old password, 47H. 49 Revised 12/90DISPLAY WHAT YOU DO ea rrnaeioneds 5, Press Enter. S711 New Password g Pore Press number(s); Then press “Enter” New Password 5711 Peete Press number(s); ‘Then press “Enter” 8. Type S New Password 5711 vee ori Verity Passw.: 2 Press number(s); Then press “Enter” New Password 5711 ce Verify Passw.: 5711? Re astnie: Press number(s); Ine arene ee a Then press “Enter” CORRECT QC CHART Outliers caused by incorrect instrament use can be deleted if'the user knows the pussword ATTENTION: Change factory-set password to avoid abuse Revised 92 4.10f wm SNOLIVaAO. MD WHOM PROGRAM KEY OPERATIONSPROGRAM KEY OPERATIONS ‘To quickly view all functions of the Program key, press Program? The following is displayed ‘Test Program: Status 2: Change Input new program 4: Delete program 1 ‘The program key allows you t * Check the status of a test program (and print program parameters for a test individually pro- gtammed by you) + Make changes to programs that do not affcet the algorithm + Program oF re-pragram a test * Restore an unlocked test program to factory status, or delete changes (not affecting al- ‘gorithin) to a locked test program HELP TEXT IS AVAILABLE, CHECKING THE STATUS OF A TEST PROGRAM — [Code 1: Status] Telly You: the testis factory programmed for BAYER DIAGNOSTICS Reagents ‘if the test has heen programmed individually by you + ifthe testis not programmed Allows You ‘To Obtain 2 Printout of Program Parameters: * fora Jocked or unlocked test that is individually programmed by you (not factory programmed) Revised 501HOW TO CHECK PROGRAM STATUS EXAMPLE #5 DISPLAY Press Test key or test code number (date) (time) Test program: _ 2: Change: i: new program table program ‘Test program: Please select a Test by Code or Pressing a Test key ‘Then one of the following three displays appear: BAYER DIAGNOSTICS X’s = test name abbreviation Or 1X5 = test name abbreviation (est name abbreviation or test ntimbers t= 10. WHAT YOU DO 1. Press Program Press 1 3. Press Test key Or, Press digits corresponding to test code number. Then, press Enter. + Ifthe test is factory programmed. # Ifthe testis individually programmed by you. Press 0 to return to previous display; Or, Press 1 to print test parameters. Reminder: If Abort is pressed while printing is in progress. press Paperfeed (to advance paper at least one line) after printing stops. ‘This ensures that text/data printed next, will not be printed over the last line of aborted text += Ifthe test is not programmed. Revised S91PROGRAM KEY OPERATIONS CHANGING PROGRAM PARAMETERS THAT DO NOT AFFECT ALGORITHM - [Code 2: Change] * Changes may be made for “locked” or “unlocked” tests Changes depend! on the test selected; may consist of any combination of the following 5 parameters? 1. Normal Range 2. Aspiration Volume (Reminder: Factory Set to 1000 3. Standard Concentration 4, Linearity Check: Maximal Acceptable Deviation 5. No. of Calibration Replicates (Reminder: Factory Set to 0 * HELP TEXT IS AVAILABLE: Press HELP to print list of parameters that can be changed for the test selected. HOW TO CHANGE PROGRAM PARAMETERS DISPLAY Press Test key or test code number (date) (time) Test program: 2: Change Test program: Please select a Test by entering Code or pressing a Test key WHAT YOU DO 1. Press Program, 2. Press. 3. Follow on-sereen user guide. 53 Revised 12/90PROGRAMMING OR RE-PROGRAMMING A TEST - [Code 3: Input new program] The test must be “unlocked” + Test programs for PT and PTT (coagulation tests) are not re-programmable. ‘= Entered program parameters are automatically printed. Reminder: Press SELECT, 40 to obtain a list of tests available via test code number. Note that the first ten tests are unassigned and reserved for tests of your choice. ‘TYPES OF ALGORITHMS End Pott wit: ~ factor and reagent blank value* — factor and sample blank values ~ standard and reagent blank value" ~ standard and sample blank values standard and sample, reagent and standard blank values Kinetic Two poiat with standard ~ Two point with standard and reagent blank value ~ Enz Multipoinc calibration curve with up to 7 calihrauars ani: ~ reagent blank value — sample blank values “Bichromatic measurement is possible for all available wavelengths except 340 nm (u.. range) after selecting any end point measurement algorithm with only reagent blank value. The chart on the next page shows program pa- rameters for all available algorithm selections. Revised S91 54PROGRAM KEY OPERATIONS PROGRAM PARAMETERS FOR EACH ALGORITHM MULTIPOINT - CALIBRATION ENDPOINT a CURVE : Fact Pact Stender Simdird! Su! on ‘With Reagent’ PROGRAM | Rowent Samp “Remgent| Sop’) opmog | 2PL S| ame Some PARAMETERS| SOx) ‘suuk ‘Mam Ramsay vm | "anu ar Waive Shes aloe Yalu "Sates atwe Values Winelengt bore < € E | me me Unis «© € € * | me me Normal Range ‘or confirm no Normal Range | ee © « k x kim me Sample Vorume | ee ¢ € € * E a Reagent Volume | ee © © k E tame me Aspiration Volume eb © © k x s_| me me Deeciensl Places fm Reval ee: ie ¢ © k x t | im me “Temperanire oF ao temp. control < © € i E me Facior aT x Standard = = = ik k Retin Reagent Blonk Value . . © k Measurement Time (7, and k x Temperature ined k k ‘ Minimal Start [Absorbance k Delay Time ‘ Measurement ‘Tune Interval x Linearity Max Deviation k Numer of Readings k Measuring Range me Number of Calibration Replicates meme 38 Revied 991RE-PROGRAM A TEST EXAMPLE #6 Enter ‘Test Program for: End Point Determina- tion (standard and reagent blank value) and bi- chromatic measurement To make this example more meaningful: We have selected only the wavelength (to ensure bichromatic measurement option). You are free to make your own selections for the remaining peo- gram parameters, DISPLAY WHAT YOU DO. Press Testkey or 1. Press Program, 2. Press 3, 3. Press Test key (or press Code Number, then Enter) 4. Press 1 5. Sequentially press 1 until “End point with standard and reagent blank value” is displayed Revised 5/91 56EXAMPLE #6— continued DISPLAY ‘Temperature [°C] 0: no temp. control 1:25 2:90 3:37 Normal range from 1.111 (units) Press number(s) Then press “Enter” Blinking 1'\ = lower limit of normal range (actual decimal places may vary) Normal range from 1.111 (units) to uu.uuu (8) Then press “Enter” Blinking u's = upper limit of normal range (ac~ tual decimal places may vary) Reaction siope Please select: 0: decreasing 1; increasing Retain reagent blank value after test selection 0: no tyes Sample volume: KR Yh Press number(s) Then press “Enter™ WHAT YOU DO 13. Press the digit comesponding to the desired temperature option. NOTE: The parameters printed indicate the selected temperature. The printout docs not indicate a “no temperature control” selection, 14, Press Enter to accept blinking digits as the lower limit of the normal range: Or, ‘Type numbers corresponding to lower limit of normal range. Then press Enter. (Or. if'no normal range is desired, type O's. ‘Then, press Enter) 1S. Press Enter to accept blinking digits as the Upper limit of the normal range: Or, ‘Type numbers corresponding to upper limit of normal range, Then press Enter. (Or, if no normal range is desired, type O's. ‘Then, press Enter.) 16, Press digit corresponding to desired reaction slope. 17. Press digit corresponding to desired action. 18, Pross Enter to accept blinking digits as the sample volume; Or, ‘Type numbers corresponding to desired sample volume. Then press Enter. Revised 12/90PROGRAM KEY OPERATIONS EXAMPLE #6~—continued DISPLAY WHAT YOUDO 19. Press Enter to accept blinking digits as the reagent volume: Or ‘Type numbers corresponding to desired reagent volume. Then press Enter. 20, Press Enter to accept blinking digits as the aspiration volume; Or, ‘Type numbers corresponding to desired aspiration volume. Then press Enter. 21. Wait for all test parameters to be printed Or, Press Abort to cancel printing. Reminder: If Abort is pressed while printing is in progress, press Paperteed after printing stops (to advance printer paper at least one line). 59 Revised 12/90DELETING AN UNLOCKED TEST PROGRAM - [Code 4; Delete program] » Restores an unlocked test program to original factory status (BAYER DIAGNOSTICS program or no program, whichever is the ease). ¢ All calibrations and blank values are also deleted for the selected test. NOTE: If you would like to reset (at one time) the entire systein (Basic set up parameters and test programs) to factory selections, use the Select key (refer to Section 4), HOW TO DELETE AN UNLOCKED TEST PROGRAM (Restores factory program status) DISPLAY Press Test key or test code number (date) (time) ‘Test program: 1:Status 2: Change : Input new program 4; Delete program Test 2 Please select a Test entering Code or een areal eo WHAT YOU DO |. Press Program. Press 4 3. Follow on-sercen user guide, Revised S91 5.10PROGRAM KEY OPERATIONS, DELETING CHANGES TO LOCKED TEST PROGRAM — [Code 4: Delete program) + cannot delete algorithm: * can only delete changes made when “2” in following display was selected: ‘Test program: 4:Status 2: Change 3: Input new program 4: Delete program ges deleted are test dependent and may st of ‘Normal Rat — Aspinition Volume (Reminder: Factory Set 0 1000 wl.) ~ Standard Concentration Linearity Check: Maximal Acceptable Deviation ~ Number of Calibration Replicates (Re- minder: Factory Set to. 0) © Ail calibrations and blank values are also deleted for the selected test NOTE: If you would like to delete (at one time) all char ges made to all tests, and reset all basic set Lup parameters fo factory selections, use the Seleet key (refer to Section 4), HOW TO DELETE CHANGES TO A LOCKED TEST PROGRAM DISPLAY Press Test key or test code number (date) (time) Test program: 1:Status 2: Change 3: Input new program 4: Delete program Test program: Please select a Test by entering Code or pressing a Test key WHAT YOU DO 1. Press Program, 2, Press. 3. Follow on-screen user guide. Revised 12/90aN SNORLV AAO ABSORBANCE KEY OPERATIONSABSORBANCE KEY THE ABSORBANCE KEY ‘+ measures absorbance at 340, 405, 500, 546, 578. 620 oF 670 nm (whichever is selected just after “Absorbance” key is pressed) * functions with both flow cell and disposable cuvette systems + is factory programmed for BAYER DIAGNO- STICS (End point with factor and reegent blank value) ‘¢ check program status (BAYER DIAGNOS TICS or other ‘= change norm: « input a new program # delete changes to the BAYER DIAGNOSTICS program or delete the entire program entered ‘by you (testores factory program status) age or aspiration volume HOW TO MEASURE THE ABSORBANCE (Flow Cell Active — SERA-PAK Status) DISPLAY WHAT YOU DO Press Test key or 1. Press Absorbance. test code number (date) (time) 2. Press 0 to select 340 nm. Wavelength: 340nm z Please select: os Hyeetans Sequel pres uni he desi : wwavelenath is displayed. Then, press een confirm choice. Absorb. (appears fora few seconds) 6.1 Revised 5/91EXAMPLE #7—continued DISPLAY Rinse flow cell Press “Rinse” key to aspirate about 5 ml water from test tube Rinsing in progress (displayed while “Rinse key is pressed) Absorb. Absorb. ready Aspirate XXXX 1 of Reagent blank solut. (Reagent) your chosen aspiration ne (via Progeam key) or the factory set volume of 1000 yal Absorb. ready (displayed while “Reagent blank value stored” is printed) WHAT YOU DO. 3. Press Help. Follow printed instructions describing how to rinse flow cell, 4. Press aspiration button to aspirate reagent blank solution from test tube. Revised! 12/90ABSORBANCE KEY OPERATIONS EXAMPLE #7 - Continued DISPLAY WHAT YOU DO pe see aa a oeptasdugi sll Aboot ready a Senet ‘solution pnt + Sample) 0.000 A Absorb. (displayed while the sample number and absorbance value are printed) Repeat Step 5 for additional samples 63 Revised 12/90QUALITY CONTROL (QC) KEY OPERATIONS THE QC KEY: USE THE QC KEY TO: * Functions only afier a test is selected and the + Label and store the next result as a QC-Normal instrument is ready to perform an analysis or QC-Abnormal result + Enter the QC range * Print control charts * Delete ull QC results + Print all QC results CORRECT QC CHART * Out on ATTENTION: Change factory-set password to avaid abuse. rs caused by incorrect instrument use cleted, if the user knows the pass- 71 RevisedLABELING AND STORING THE FIRST QC RESULT The first QC result refers to the first result stored for the test or the first result stored after QC memory has been deleted. Tn either case, the instrument will prompt you to center the QC range before the first QC analysis is performed. + Ifthe instrument does not prompt you to enter the QC range, the QC range has already been entered and one or more QC results have already been stored. DISPLAY WHAT YOU DO XXXK QC select: 1. Press #1” or #2” 4 Se * the riext result will be labeled as either a 2: Store abnormal normal or abnormal QC result (whichever 3: Print statistics ‘you choose) and then stored in cither the QC-Normal or QC-Abnormal memory XXXX's = test name abbreviation (whichever applies) 2. Type in digits corresponding to the lower limit CC ane oT ial of QC range ‘Type value; Press Enter. then press “Enter” tor Abnormal whichever selected 3, Type in digits corresponding to the upper come ere Tint of QC range. ae = 3X QC Memory Analyze the sample. The result will be stored Feout wil bo QC meas ‘stored Revised 12/90QC KEY OPERATIONS LABELING AND STORING QC RESULTS (not the first) * Upto 50 normal and up to 50 abnormal QC results can be labeled and stored for each of 50 tests DISPLAY WHAT YOU DO XXXX QC select: have ancl 1: Store normal +» the new result will be labeled as either a 2: Store abnormal normal or abrormal QC result (whichever 3: Print statistics you choose) and then stored in either the QC-Nornal or QC-Abnormal memory XXX's = test name abbreviation (Whichever applics) XXXX QC Memory Analyze the sample. The next result will be Result will be stored in QC memory: stored Repeat procedure for each QC sample (up to 50). 73 Revised 12790PRINTING QUALITY CONTROL CHARTS, DELETING QC MEMORY, PRINTING QC RESULTS + (Wo oF more QC results must be stored fora statistical analysis, DISPLAY XXXX QC select: 4: Store normal 2: Store abnormal 3: Print statistics XXNX's = test name abbrev 1. Continue 3: Delete OC memory 4: Print all values WHAT YOU DO. 1. Press3 The QC-Normal control chart (statistics and graphics) is printed. 2. Press The QC-Abnormal control (statistics and graphics) is printed. Or, Press 3 to delete the entire QC memory. Or. Press to print all QC results n asterisk (*) marks each out-of-range ac result Revised 1/92 74ANALYZI SAMPLISAMPLE PREPARATION AND ANALYSIS SAMPLE PREPARATION © Musing BAYER DIAGNOSTICS Reagents, prepare samples according to provided instruc: tions = If using other reagents, follow the instructions provided hy the manulaeturer. Do not use test tubes longer than 55 mm or the aspiration tube will not touch the bottom of the test tube ATTENTION: Make sure that there is ne cuverte in the cuverte compartment when sclecting atest SAMPLE ANALYSIS: Complete instructions for analyzing the sample are provided on the display. In addition to display instructions * Test information is printed the first time a particular testis selected after the power is turned ON. ‘+ Printed test information depends on the test selected (algorithm dependent), Although not required for routine testing, you may use the following keys while the flaw cell is active: * Blank + Cali * Analyze &t Revised 3USING THE BLANK KEY (flow cell active) 1. The first display (below) appears after you have finished a rest run that uses sample blank values DISPLAY WHAT YOU DO (test result) 1. Press Blank. Series finished Press “Blank” key 2. Follow display Dales Pore teepee instructions. Press number(s): Then press “Enter” 2. When analyzing tests requiring a reagent blank value, you may press Blank to enable you to analyze a new reagent blank and store its value, EXAMPLE: (test reaun) 1. Press Blank, 1 Aspirate 1000 11 of | Sample solution (test result) Follow display instructions Revised 12290