MILES. a ——————— @ RA-1000° system REFERENCE MANUAL @ mies/AA _—= ‘Miles inc., Diagnostios Division Publication No, UA8-2506A24 / November 1993, ‘Tarrytown, NY 10591-5097 USA ‘This pubcaion supersedes Toca Punteabon No, UAB 2506485 Peb 1968, ors 64.005 x80PUBLICATION CHANGE RECORD PUBLICATION No. DATE PUBLICATION No. DATE us0-2506-00 July 1982 Us8-2506820 February 1985 as-2506821 January 1986 uss-2s06a22 January 1989 uss-2506823 February 1989 uae 2506826 November 1993 LIST OF EFFECTIVE PAGES DATE GE No. DATE November 1992 Novernber 1999 February 1989 November 1993 ivthrough xis Febeuary 1909 {1 through 1-51-46 February 1989 @ 2ithrough25172-52 February 1989 3-1 through 3-60 Febeuary 1989 a February 1989 2 November 1983 3 through 4.66 February 1989 as November 1993 ‘44 throughs? February 1989 ‘es2nand e528 November 1993, 453 through 4771678 February 1989 1 though 5-4915:50 February 1989 6-1 though 635 February 1989 7a through 7-74 February 1989 8-1 through 824 February 1989 9-1 through 912 February 1989 INDEX: through Now 0 February 1969 * Page(s) changed by current revision. A Rewsed: November 1993,TABU: @ Table Of Contents Section INTRODUCTION Purpose of The Reference Manual Organization of The Reference Manual Instructions for Use of the Reference Manual Identification of Hazards Interpretation Results Formats Used to Represent Keypad Entries, LED Messages, and Printed Messages Warranty EmergencyTelephone Troubleshooting DESCRIPTION Introduction Functional Description Controls and indicators Detailed Description Reagent and Sample Delivery Reagent Delivery Sample Delivery Analytical Procesing e 5 Reaction Tray ek Reaction Tray Module Colorimeter Assembly ‘System Control and Data Handling CPU & Memory VSIPC Board assembly Serial VO PC Board Assembly ‘AC. Motor Control PC Board Assembly 4 Stepper Motor Control and Front Panel PC Board Assembiy Data Acquisition PC Board Assembly Disk Drive Assembly Temperature Controller Assembly Operator interface Display PC Board Assembly Control Pane! Printer Assembly Electrical Power Distribution ‘Summary of System Specifications General Sample De Reagent Delivery Reaction Tray Optics Temperature Control Data Handling Installation Specifications Physical Dimensions and Space Requirements Environmental Requirements Ventilation Requirements Electrical Requirements Waste Disposal Requirements Optional Equipment ISE Option ISE Specifications Technicon RA-1000 Data Manager ‘Data Manager Specifications TEN: Page sitsTABLE OF CONTENTS Section ' Table Of Contents (Cont) DESCRIPTION (Cont) User-supplied Serial Printer Technicon IDee Option. ‘CALCULATION OF RESULTS Introduction Calculation of Reported Results ‘SLOPE and INTERCPT Chemistry Parameters UNIT FAC Chemistry Parameter Absorbance Data Provided By Printer Output Formats 2 and 3 Calculations Performed for Zero-Order Chemistries Calculation of ASSAY RESULT Substrate Depletion Check for Inverse 340-nm Chemistries Calculations for First-Order Chemistries Calculation of ASSAY RESULT Substrate Depletion Check for Inverse Chemistries Calculations for Endpoint Chemistries Calculation of ASSAY RESULT (Without Sample Blanking) Calculation of ASSAY RESULT (itn Sample Banking) ‘Sample Blank Assay Bichromatic Analysis, Variable Bichromatic Analysis Calculations for Two-reagent Chemistries Two-reagent Endpoint Algorithm Automatic Linearization for End-Point Assays Calculations for Blank-corrected Zero-order Chemistries Calculation of ASSAY RESULT Blanked Rate Algorithm Calculations for Quadratic Rate chemistries Calculation of ASSAY RESULT Calculations for immunoassay Chemistries COMPUTER COMMAND CODES Introduction 3-1 Function Computer Command Codes Subfunction Computer Command Codes ‘OPERATION Introduction Startup Start-up Procedure Loading Reagents Loading Samples Routine Operation Routine Operation Dally Checks and Cleaning STAT Procedures STAT Protocol for All Operating Modes Except AUTO REQUEST STAT Protocol for AUTO REQUEST Operating Mode Reagent Tray Configuration Reagent Tray Configuration Profiles Default Profiles Saving Reagent Tray Configurations, Profiles, and Default Profile Entry Developing Reagent Tray Configurations and Profiles Example A: Entering a Reagent Tray Configuration and Profiles Example 8: Changing a Reagent Tray Configuration and Profiles Issued! February 1989 Page 1-45/1-6 1-45/1-46, 415/416 a7 a7 a7 421 421 422 423 4.23 42a 424 428 425 4.28 431TABLE OF CONTENTS Table Of Contents (Cont) Section Page v OPERATION (Cont) Work List General Work List (Number) Status. Work Lists for RB Rate and Reagent Blank Samples Work Lists for Calibration Samples ‘Work Lists for Unknown Samples Prepared at Technicon RA-1000 Keypad Work Lists and Peripheral Computers i Test Selectivity in AUTO REQUEST Made Test Selectivity in WORK LIST DOWNLOAD Mode Example C: Entering a Work List at the Technicon RA-1000 Keypad Example D: Changing a Work List i Example €: Managing Work List Downioaded RB Rates and Reagent Blanks Calibration Introduction Calibration of First-order and Endpoint Tests. Calibration of Zero-order Tests: ALT, ALT/P, ALTP2, AST, AST/P, ‘ASTP2, CK, LD, LD(P->L), and LO (P-+1) 2” Calibration Procedure Calculations e Theoretical Basis for Calculations ‘ibraton of Zeroorder ALP and ALP (DEA) Tess Calibration Procedure Calculations Theoretical Basis for Calculations Calibration ofZaroxorder Amylase (405 nn Test Calibration Procedure"... Calculations ... Theoretical Basis for Calculations Calibration of Zero-order Amylase (AMS-L) Test. Galibration Procedure Calculations ‘Theoretical Basis for Calculations Calibration of Zero-order GGT Test Calibration Procedure Calculations .. Theoretical Basis for Calculations Calibration of ISE Tests (Two-point Calibration) Calbration of Immunoassay Tests Calibration Procedure Detailed Explanation of Immunoassay Calibration Special Operations Configuring the CPU & Memory VSi PC Board Configuring a Program Disk Copying Program Disks Technicon iDee Option Description ‘Selecting the Technicon iDee Option IDee Request Mode IDee Auto Mode Iee Manual Mode @ Ordering Sample Blank Correction for Endpoints in iDee Manual Mode Reagent Consumption Monitoring Operation of a User-supplied Printer evsed, Novernbe’ 1993,Ta INTENTS Table Of Contents (Cont) Section Page Ee eh otto s He aihe favicon aod te ale 3s rene 2d De 8 ne SPB Again Take (crenata ae En 3 fans sar ates TSMS i Rehan ft coca 3 Hehe (mmeeteyascae sa 8 TENG IS feeieenbe Neder Bg Ladin ti 2 BZ @ soa ia g Jn Stati Aa ee Pee ne TENG SoCal Sh et oes reali s aeaurrd a =f fenhe te seemen ae ig Behar seeeeniacas i TORS fincas si ERS 4 gumearerey HI Tne (are Sear i Test No. 20- Reaction Tray index Test, Test No. 21 = Reaction Tray Mix Test Test No 22 Printer Test Test No 23 Filter Wheel Test (Alignment) Test No 24- Reaction Tay Step Tet Alignment) Test No, 25~ Air Bar Test, Test No. 26 ~ Alarm ON/OFF Test ‘Test No. 27-10 Read Test ‘Test No. 28 Frequency Select Test No. 29-ISE Probe Test Test No. 30-1SE Valves Test v Issues: February 1989Section vw TABLE OF CONTENTS Table Of Contents (Cont) ‘TROUBLESHOOTING (Cont) Test No, 31-ISE Pump Test Test No. 32 Disk Read Test Device Tests ‘Voltage Monitor Panel Test Air Pump Device Test MAINTENANCE Introduction Preventive Maintenance Maintenance Schedule Care of Reagent and Sample Probes Parts Replacement Illustrated Parts Breakdown Manual Calibration After Replacement of Critical Parts Replacement of Syringe Assemblies Exercising Care When Removing Reagent Probe Electrical Cable Exercising Care When Reattaching Electrical Connectors Special Alignment Procedures ‘Alignment of Sample and Reagent Probes Reagent Probe Test Procedure 2 Introduction Reagents and Supplies Needed to Perform the Probe Test Procedure Reagent Probe Test Procedure Reagent Probe Troubleshooting Guide USER-DEFINED METHODS, Introduction Getting Started ‘What Are Chemistry Programs? How To Create and Run a Chemistry Program General instructions For Determining Chemistry Parameter Vaiues Managing Chemistry Programs 3 Entering Chemistry Programs Editing Chemistry Programs Copying Chemistry Programs Onto Another Program Disk Deleting Chemistry Programs Description of Chemistry Parameters ‘Automatic Dilution ‘Auto Dilution Methods Determining Chemistry Parameter Values for an Auto Dilution Method Determining Parameter Values for Zero-order Methods Procedure To Determine Values For C1108 ~ 6, C2+10E ~ 6,and D1=10E -6 Procedure To Determine Value For DELTA # Procedure To Determine Value For DEP Lit mining Parameter Values for First-order Methods Procedure To Determine Values For LIN FACT and 1ST LIM Procedure To Determine Value For DEP LIM Determining Parameter Values for Endpoint Methods Procedure To Cetermine Value For EP LIM Bichromatic Analysis vs Sample Blank Assay Procedure To Determine Values For BIC FACT, BIC FACZ, BIC LIMT,BIC LIMZ Determining Parameter Values for Blank-corrected Zero-order Methods Procedure To Determine Values For C1+10E ~ 6, C2+10E ~ 6, 01-108 — 6, DELTA #, DEPLIM S45, 5-46 5-47 5-47 549/450TABLE OF CONTENTS Section vi va Table Of Contents (Cont) USER-DEFINED METHODS (Cont) Determining Parameter Values for Quadratic Rate Methods Procedure To Determine Values For C1-10E ~ 6 and C2+10E-6 Determining Calibration Parameter Values for Immunassay Methods ‘Chemistry Programs for immunoassay Methods : How To Prepare An Immunoassay Chemistry Program When All Chemistry and Calibration Parameter Values Are Known How To Prepare An Immunoassay Chemistry Program When Calibration Parameter Values Are Not Known Le Entering Calibration Parameter Values for Immunoassay Methods List of Immunoassay Calibration Parameters Procedure To Determine Values For LIM, SLM, RSP, 9% RSP, and RSS LIM ‘CHEMISTRY PARAMETER VALUES FOR TECHNICON-DEFINED METHODS. ‘SUPPORTED BY VERSION 2.8 SOFTWARE LABORATORY COMMUNICATIONS, ‘SUBJECT INDEX leswed: February 1989,INTRODUCTION INTRODUCTION PURPOSE OF THE REFERENCE MANUAL This Reference Manual has been written to document the clinical use of the TECHNICON RA-1000° system and to comply with the regulations governing In Vitro Diagnostic Products for Human Use, issued by the Food and Drug Administration (FOA) under the provisions of the Federal Food, Drug, and Cosmetic Act ORGANIZATION OF THE REFERENCE MANUAL The Reference Manual is comprised of eight Sections that provide the pertinent descriptions and Procedures required to successfully operate, troubleshoot, and maintain the Technicon RA-1000 system. © Section!, Description Provides functional description that explains how the instrument operates as a system to report a clinical test result. Detailed descriptions discuss each of the individual assemblies that comprise the system, © Section Il, Calculation of Results Gives a detailed explanation of the calculations performed for each type of colorimetric assay performed by the system © Section il, Command Codes Describes each of the command codes by which the operator communicates with the system © Section tv, Operation Provides the specific instructions required to start up and to operate the system. Included are details concerning reagent tray configuration and worklist assignments, the calibration of ‘methods, and the insertion of STAT samples © Section, V, Troubleshooting Provides recommended action for each alarm message that alerts the operator to 2 possible malfunction. © Section Vi, Maintenance Contains the preventive maintenance schedules and procedures required to maintain the performance characteristics of the system. © Section Vi, User-defined Methods Provides instructions that enable users to prepare their own chemistry programs. © Section vitl, Chemistry Programs for Technicon Methods Gives a complete listing of parameter vaiues for each Technicon Chemistry Program, © Section 1X, Laboratory Communications Contains the current documentation that describes the interconnection of the Technicon RA-1000 system and a peripheral computer. INSTRUCTIONS FOR THE USE OF THE REFERENCE MANUAL ‘The operator 1s urged to become familiar with the contents of the Reference Manual before attempting tooperate the system To locate specific information, first turn to the TABLE OF CONTENTS. if the desired information cannot be readily found, consult the SUBJECT INDEX that is located after Section IX lesued: February 1989 viINTRODUCTION IDENTIFICATION OF HAZARDS Technicon systems incorporate safety features to protect the operator from injury, the instrument from damage, and the test results from inaccuracies. A bold-captioned heading is used to identify the possible hazard and to call the operator's attention to the existence of this condition, Hazards that could be encountered while operating the system are categorized as follows: WARNING Indicates operating procedures, practices, etc, which could result in personal injury of loss of life if not correctly followed, Indicates operating procedures, practices, etc that, if not strictly observed, could resutin damage o or destruction of equipment Indicates operating procedures practices, etc that, if not strictly observed, dicates operating procedures practices, etc that. if not strictly observed, could adversely affect the function (test results) of the equipment. Hazards that are associated with the presence, handling, and use of required reagents are categorized as, follows: DANGER! Indicates a hazard that is life threatening. This hazard is assigned to substances that are highly toxic, extremely corrosive, or extremely flammable. WARNING! Indicates a hazard that is injurious but not life threatening under ordinary circumstances. This hazard is assigned to substances such as toxic liquids or ‘gases, irritants, or flammable materials cauTiON! Indicates a hazard that could cause illness, burns, skin reactions, etc. This hazard is assigned to substances such as diluted acids, mild caustics, minor skin irritants, or combustible materials. INTERPRETATION OF RESULTS. System operators and laboratory supervisors are responsible for operating and maintaining Technicon Products in accordance with the procedures described in the applicable Product Labeling and for determining that these products are conforming to the applicable performance claims. if, under these prescribed conditions of operation and maintenance, an aberrant result, as defined by the laboratory protocol, occurs, laboratory personnel should first make certain that the system is peforming in ‘accordance with the Product Labeling; then follow the laboratory protocol for advising the clinician of @ result that appears to have deviated from the norms established by the laboratory. Technicon makes ‘every effort to identify in the Troubleshooting, Maintenance, Merits and Limitations, and Bibliography sections of the Product Labeling the potential effects on patient results caused by instruments, reagents, ‘or other endogenous sources. This information is provided in lieu of attempting to define the need for additional testing which involves medical judgement. The decision whether or not to report a diagnostic result rests with the laboratory, Technicon products do not make diagnoses on patients Technicon intends its diagnostic products (ystems, reagents, software, hardware, etc) to be used to collect data reflecting the patient's chemical, hematological, oF immunological status ata certain point in time. Such data must be used in conjunction wath other diagnostic information and with the attending physician's evaluation of the patent's ‘condition in arriving at a diagnosis and a course of treatment Any malfunction of a Technicon diagnostic product (je, failure to meet a peformance specification or otherwise to perfrom as intended) should be appropriately addressed by the laboratory personnel Various sections of the Product Labeling previously noted address malfunctions and their possible effect on resultsINTRODUCTION FORMATS USED TO REPRESENT KEYPAD ENTRIES, LED DISPLAY MESSAGES, AND PRINTED MESSAGES ‘Communication between the system and operator is accomplished via a keypad, an LED Display, and a Printer. The following formats are employed in this publication to represent keypad entries performed by the operator and system messages generated by the LED Display or Printer, Keypad Entries The keypad contains numeric keys and control keys. The numeric keys are used to enter variable items of information, while the control keys instruct the system to process an entry in a specific way. The following numeric keys are portrayed in bold typeface that is one size larger than the surrounding text: . (decimal point), 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12. The following control keys are depicted in bold typeface enclosed by the less than and greater than symbols: , , , , , , , , and . For example: To bypass the thirty minute warm-up timer, the operator sequentially presses the 6 key, the 3 key, and the control key. In condensed form, this sequence of events, canbe shown as 6 3 . LED Display Messages Messages that appear on the LED Display are portrayed in a bold typeface (eg, PRG LOAD) Printed Messages Messages generated by the Printer are represented in an ic typeface (e g, ENTER TIME). sued: February 1989 *WARRANTY WARRANTY THE FOLLOWING WARRANTY 15 IN PLACE OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, AND ALL OTHER WARRANTIES, INCLUDING WARRANTIES AS TO MERCHANTABILITY OR FITNESS, ARE EXPRESSLY EXCLUDED, 2. SYSTEMS, PARTS AND LABOR. Technicon warrants purchased equipment (except consumable supplies and gis tubing 3nd cots and heensed software tobe fre of detects n material and workmarshia under norma use and marnterance fm the date ot snipment fora period of one yenr (90 daysin the case of (i fuses, lamps ight emitting odes, vacuum tubes and cathode ‘ay tubes, il pares n contact th te reagent steam, ncuaing owcels, lyse blocks, cartnege type nesting Bats. electrodes tnd imjecvon blocs, and fl separately purchased replacement ports, and 780 days n the cate of Bverhaules modules 406m ‘exchange for similar nonfunctioning modules). Consemable suppies (nciuding pump tubes, sample Cuot and chart pager) and ‘las tubing and cols are warranted to'be fee of defects 9 materal ang workmanship atthe time of pment. cabornvoreed {Connection with repars performea at a Techn con faclty # warranted for 8 eroc ot 90 days rom the gate of pment oF the ‘eoared equipment. The putenoted equipment and icereed software warranty terminater on transfer of tte t0 the Butchated quoment 1b CHEMICALS. Technicon warrants purchased chemicals to be free of defects in material and workmanshp at the time of shipment. and, pronded Techricon'ssorage intruchons are sincty a@heree to, Techmcon warrants he freshest of chemeals Untied appearing onthe container © __UMITATION OF REMEDY. Technicon shall have no labity for any direc, incidental or consequential damages resulting ‘rom breach of warranty, fom the breach or nonperformance of any term or condioon hereof oF from Tecnnicons actual of imputed negigence. Inthe event of any uch breach, nonperformance oF negligence Techncon’s abity small be ime) in the ‘ate of purchased equipment or eensed software. to repsiting o repiacing (with 9 new component oF ore equivalent new 0 Performance) any eomaonert which Tecancon fad 40 be detective in material or workmanship, t Teehncons option ether at buyers instalation ste o a Techncon facity dengnatee by Techncon(hypment to such fait to be at Techmcom's expense ‘Technican finds tre component to be defective in materal or workmanship} Jn the cae of abor mvoiced m connection wth ‘epars, at Technicons election 10 correcting ary workmanship which Technicen finds to have been defective, oF refunding 0 ‘buyer the labor repave cnarges paid to Technica and (i nthe case of themcale, to replacing any chemicals which Technion ‘ina tobe nonconforming, 6. GEOGRAPHICAL LIMITATION: NONTRANSFERABILITY; INCONSISTENT LANGUAGE. This warranty does not apply to ‘Sauipment so long ass located out ote SO sates, the Distictof Colombia anc the Commonwveaith of Puerto ca. serve will not be performed outsie of such geog‘aphical area except on payment of ocaly applicable serie charges. in the case of ‘Sauspment located outs of such geograghveal aren which # retuned (n whole or ia part to Techrcon Facity within the United sates for warranty service, the transportation costs incu nsuch return shall beat buyers expante. Ths warranty f Rot {ansterable and may not oe supplemented or amended except 19 wnting referring pecially hereto ane signed by buyer ane TTecnncon Without imtng the generality of the foregoing. any inconstent language contarned in requerts for Quotation, buyer's purchase orders shipping instucuons of smiar documents pecially rejected By Technicos SOFTWARE LICENSE io tte to oF ownersnvp of software is transferred to purchaser. The software component of ths Technicon system and any ‘modvies thereto are merely icensed to purchase forts wa use on such system. Any software (reloging documentation) Browsed pursuant hereto contains proprietary information congtnting valuable trade secrets snd it protected by federal Eopyngntlaw. The software may not be dacosed, nwhole oF: par to rd partes or Supicated in any form of medium enced Ss nccasary for program execution ane archival storage x Issued: February 1969,EMERGENCY TELEPHONE NUMBERS EMERGENCY TELEPHONE TROUBLESHOOTING Technicon instruments Corporation maintains a toll-free, 24-hour emergency telephone service. The ‘purpose of this unique service is to enable our customers to contact knowledgeable Technicon personnel to receive, without charge, counseling in the installation, operation, and troubleshooting of any Technicon system or component that they have purchased from us. Before calling, it is recommended that the customer first determine that the solution to his problem, or the answer to his question, is not provided in the applicable Product Labeling or supporting technical publications. Calling Instructions for Ordering and Technical Assistance and Counsel Within Continental United States.. Toll-free technical assistance, telephone service is available 24 hours a day, 7 days a week in the continental United States, Call 1-800-241-2500 This country-wide sales and customer service number automatically routes your calls to the proper Technicon Distribution Center in the continental United States, Corporate Headquarters ‘Technicon instruments Corporation 511 Benedict Avenue, Tarrytown, New York 10591-5097 (914) 631-8000 Eastern Regional Technicenter Mid-America Regional Technicenter 600 Hadley Road, 20180 Governors Highway, Suite 100 ‘South Plainfield, New Jersey 07080 ‘Olympia Fields, llincis 60461 (201) 754-5900 (708) 481-0050 ‘Southeastern Regional Technicenter_ _ Western Regional Technicenter 472 Plaza Drive, 14791 Franklin Street, Atlanta, Georgia 30349 Tustin, California 92680 (404) 768-7021 (714) 731-6900 Outside Continental United States. For service in Canada, Mexico, and Puerto Rico call your local regional center using appropriate numbers listed below: Technicon Canada inc. Technicon Mexico 4080 Tristar Drive, Unit 5 Technicon, S.A. de C.V. Mississauga. Ontario, Canada LSL 384 Avenue Colonia del Valle, No. 615 (416) 838-1277 Mexico 12, D.F. Mexico (800) 387-8142 (805) 523-8350 ‘889 Montee DeLiesse Road Technicon Puerto Rico Montreal. Quebec. Canada HaT 1P5—_Technicon instruments Corp. (514) 341-3100 65th Infantry Avenue Stalion (800) 361-7126 P.O. Box 28431 Rio Piedras, 00929, Puerto Rico 6151D Westminster Highway (809) 852-1035 Richmond, B.C., Canada V7C ava (604) 272-2351 (800) 663-0921 Issued: February 1989 ipaSection | DESCRIPTION INTRODUCTION INTRODUCTION, This Section provides information to familiarize the user with the operational characteristics and the specifications of the TECHNICON RA-10008 system. TOPICS COVERED IN THIS SECTION Introduction 1-1/1-2 Functional Description Controls and indicators Detailed Description Reagent and Sampie Delivery Reagent Delivery Sample Delivery Analytical Processing Reaction Tray Reaction Tray Module Colorimeter Assembly ‘System Control and Data Handing CPU & Memory VSI PC Board Assembly Serial VO PC Board Assembly A.C. Motor Control PC Board Assembly Data Acquisition PC Board Assembly Disk Drive Assembly ‘Temperature Controller: Assembly, Operator interface Display PC Board, Assembly Control Panel Printer Assembly Electrical Power Distribution System Specifications General ‘Sample Delivery Reagent Delivery Reaction Tray Optics Temperature Control Data Handling Installation Specifications Bhyseal Dimensions and Space Requirement Environmental Requirements Ventilation Requirements Electrical Requirements Waste Disposal Requirements Optional Equipment ISE Option. ISE Specifications Technicon RA-1000 Data Manager ‘Data Manager Specifications User-supplied Serial Printer Technicon IDee !Option ‘Stepper Motor Control and Front Panel PC Board Assembly BERSES BREEESES 8 1a) vat vat 1-42 1-43 1-45/1-46 1-45/1-46, saved: February teeFUNCTIONAL DESCRIPTION FUNCTIONAL DESCRIPTION ‘The TECHNICON RA-1000® system (Figure 1-1) is a bench-top, computer-controlled, random access chemistry analyzer. It can be kept available for operation on a 24-hour basis with a minimum of ‘operator attention; no routine adjustments are required. REAGENT SYRINGE RANDOM AccESS REAGENT/SAMPLE FLUID REAGENT BOTTLE Penwowr assemsy / REAGENTPROBE DISK DRIVE Lep pispLay SAMPLE SYRINGE SAMPLE TRAY SAMPLE PROSE REACTION TRAY ti REAGENT TRAY Figure 1-1 TECHNICON RA-1000 SYSTEM The system is designed to perform the following types of assays at 30°C or 37°C: zero-order rate, first- order rate, endpoint, blank-corrected zero-order rate, and quadratic rate. The system can maintain a library of up to 63 methods. Of these, a maximum of 15 tests (when optional ISE* tests are included) can bbe performed for each sample. Information concerning Technicon-defined methods is provided in Technicon RA-1000 System, Methods Manual. For information concerning the preparation of your own methods, refer to Section Vil, USER-DEFINED METHODS. Depending on the specific test ordered, the throughput time for an individual assay is between one and ten minutes. The maximum analytical rate is 240 individual assays per hour. For tests that require a ‘sample blank assay or a second reagent addition, the analytical rate for completed test results is 120 per hour. Between 2 pL and 30 pl of sample are required for each assay, depending upon the test. Ammicroprocessor directs all system functions such as assay control, data acquisition, data processing, and fault monitoring. The system is managed by one operator who programs the Reagent Tray Configuration and Work List, loads the reagent and sample trays, and initiates sample processing, ‘A Reagent Tray Configuration, which designates the reagent order on the removable, fourteen-position reagent tray, must be specified before samples can be processed _The operator can recall a previously programmed Reagent Tray Configuration or enter a new Reagent Tray Configuration each time that the Feagent tray 1s loaded A maximum of ten Reagent Tray Configurations can be stored on the system program disk, With the optional ISE tests included, a maximum of 15 tests can be assigned to 2 Reagent Tray Configuration + For complete detals concerning the optional TECHRICON RA10000 ISE Module. reler ‘0 Addendum, Technicon RA1000 SE ‘Module “echinicon RA-1000 and Technicon RANDOM ACCESS FLUID are registered trademarks of Techncon Instruments Corporation Tarrytown, NY 10591-5097 sued: February 1989 13FUNCTIONAL DESCRIPTION ‘A Work List, which specifies the tests ordered for each sample loaded onto the removable, thirty- Position sample tray, must be entered before samples can be processed. For each sample placed on the Work List, the operator can order any of the tests listed in the Reagent Tray Configuration. ‘The operator can order individual tests or order a profile of tests. However, individual tests and a profile cannot be ordered for the same sample wen required, » STAT sample cn be proceed with minimal IMtarupeon tthe Wor un bong prose The operation of the Technicon RA-1000 system is divided into three modes: STANDBY, READY, and OPERATE. Figure 1-2 illustrates the functional relationships among these modes. STANDBY is the start-up mode during which there is 2 30-minute waiting period for the system to stabilize at operating temperature. READY is the waiting mode. To run samples, the operator selects a reagent tray configuration, loads the samples, and designates a work list. OPERATE is the processing mode. Each reagent and sample is quantitatively transferred from its Fespective tray position into a cuvette on the reaction tray by a dedicated positive-displacement type Pump. Each reagent aliquot is heated within the reagent probe preheater prior to being dispensed. Carryover between successive aliquots of sample or reagent is virtually eliminated by the Technicon RANDOM ACCESS FLUID immiscible separator. A peristaltic pump is used to deposit a thin, uniform film ‘of Technicon RANDOM ACCESS FLUID on the internal and external surfaces of the sample and reagent probes. This film prevents contact between the aspirated liquid and the walls of the probe. Sample and heated reagents are combined, mixed, and optically measured in one of the 100 cuvettes on ‘the disposable reaction tray. in the OPERATE mode, a fifteen-second reaction tray work cycle is repeated continuously until the last test is completed. The four main elements of the reaction tray work cycle are as follows: 1. Receive reagent and/or sample, Rotate reaction tray abruptly to mix cuvette contents, 1 to allow an optical reading for each of Rotate reaction tray smoothly past colorime’ 43 cuvettes, and 4, Position next reaction tray cuvette to receive reagent or sample. The colorimeter data, converted into a digital format, are transferred to the microprocessor. The system. ‘automatically calculates each test result which is printed out and released to the LIS interface. When ‘more than one testis processed for a sample, the system waits until all individual test results ar able before reporting these results The keypad, LED Display, and printer provide communication between the system and the operator. The system can be configured to provide all displayed and printed information in any one of the following languages: English, French, German, Spanish, or italian. The default language is English All items that require routine replenishment or replacement (e g, RANDOM ACCESS FLUID, pump tubes, etc) are directly accessible to the operator All user-replaceable modules or components (e g, PC boards, colorimeter lamp, etc) are accessible after raising the hinged, top cover nsure prope regulation ofthe aay temperature and proper seating of the tay covers, the stem must always be operated withthe hinged, top cover Closed and secured by meant of the ‘wo vetaining bots served shrough te system bate or the location ofall user-replacenble pars, eter to Technion ‘RA-1000 System, tustated Parts Breakdown, sued: FebrostyEUNCTIONAL DESCRIPTION ‘ssued: February 1989, 15-6CONTROLS AND INDICATORS CONTROLS AND INDICATORS Table 1-1 lists the function for each control and indicator on the Technicon RA-1000 system. Table 1-1 CONTROLS AND INDICATORS ‘CONTROLINDICATOR FUNCTION [Controls application of electrical power to Technicon MAIN POWER ON-OFF IRA-1000 system. Protects system from current overloads. Circuit Breaker [Mode Status indicators: STANDBY Indicator Lit while system isin STANDBY mode. See Figure 1-2. Lit while system isin READY mode. See Figure 1-2. Lit while system isin OPERATE mode. See Figure 1-2. READY indicator (OPERATE Indicator LED Display Performs the following functions: J* Displays each keypad entry. Je Prompts operator to enter required information, J Provides appropriate status and alarm messages. Within [Sounds when a keypad key is pressed, Keypad Assembly. Keypad: Tone (Beep) Generator Keys 0 through 9 are used to enter numerical data, to select command codes, and to order tests. The 10 key is used only to produce a minus sign (-) or to select the test assigned to reagent tray position 10 for a work list or profile. The 11 or 12 key is used only to select the test assigned to reagent tray position 11 or 12, respectively, for [a work list ora profile through 12 Keys [Figure 1-4 @key Figure 1-4 | Enters decimal point in a numerical input. The space key separates elements within a keypad entry Isequence. When used with a time entry, the space key produces a colon (eg: 11 4 5 = 11:45) after ‘ is pressed. In a date entry, the space key produces a slash (eg: 12 26 8 4 = 12/26/84) after is pressed Key Figure 1-4 ‘ Key Figure 1-4 [Advances the printer paper five lines Key [Figure 1-4 Enters data that appear on LED Ovsplay 4 [When preceded by the number for a prepared work list, pressing this key places system in OPERATE mode and begins sample processing. For additional details, refer to [Section IV, OPERATION. See paragraphs titled “START-UP PROCEDURE” and “ROUTINE OPERATION. ‘ Key [Figure 7 Issued: February 1CONTROLS AND INDICATORS Figure 1-3 MAIN POWER ON-OFF CIRCUIT BREAKER Lepoisruay on counsser MORESTORS® | xevsoano — FUsH'BUTTON Figure 1-8 CONTROL PANEL INTERFACE ASSEMBLY 18 Inived Febvuary 1989CONTROLINDICATOR Table LOCATION CONTROLS AND INDICATORS ‘1 CONTROLS AND INDICATORS (Cont) FUNCTION Keypad (Cont) ‘ Key Figure 1-4 Requests system to insert a STAT sample, For additional details, refer to Section IV, OPERATION. See paragraph titled “STAT PROCEDURES.” Key Figure 1-4 Executes numerical entry as a keypad command code. A. numerical entry before is pressed will be processed as a function command code. For example: 2 selects the WORK LIST function |A numerical entry after is pressed selects a subfunction command code. For example: ‘ 2 requests calibration for a specific sample [cup on the work ist. NOTE The applicable function command code must be executed before an essociated subtunction fommang code can be requested. For example P'SRUNCTION™ must be entered and 2 worklst telected before 2 valid ‘ Key Figure 1-4 Enables operator to program up to nine chemistry profiles for each Reagent Tray Configuration and, subsequently, jto request any of these chemistry profiles for a specific sample. For complete details concerning the profile function, refer ito Section IV, OPERATION. See paragraph titled “Profiles.” Key Figure 1-4 [Causes system to leave the current command code Hunction and to enter a waiting state during which the ime appears on LED Display. “ Key Figure 1-4 Erases a Keypad entry that has not been executed, The cleared entry disappears from the LED Display. Erases alarm messages, and silences the audible alarm, Note that this key does not reset a hardware alarm, which ican only be accomplished by successfully exercising the hardware function via the Exerciser Program or Exerciser, Disk. Refer to Section V, TROUBLESHOOTING. If a hardware alarm is not reset, any attempt to initiate Joperation is inhibited, and @ DEV ERR alarm message is splayed [CPU RESET Push Button Figure 14 Initiates the microcomputer restart function, the program 15 loaded from the disk, and the start-up diagnostic test, sequence is begun. All data for assays in progress are lost. lesued: February 1989 19CONTROLS ANO INDICATORS CONTROLINDICATOR ‘Table 1-1 CONTROLS AND INDICATORS (Cont) LOCATION FUNCTION Disk Drive Assembly: Disk Load/Release |Figure 1-5 | When pressed downward, secures the inserted Disk within Bar Disk Drive Assembly. When pulled upward, allows Disk to bbe removed from the Disk Drive Assembly. Busyindicator | Figure 1-5 _| Lights when Disk Drive Assemblyis active. [Audible Alarm Figure 1-6 ‘CAUTION To avoid damage to the Program Disk or Disk Drive Assembly. do not attempt to remove oF Insert the oak while the Busy Indicator i It Instead, press the CPU RESET push button. This wil provide approximately 6 208 seconds to insert the program dik before the disk drive i selected tne the Bury necator ight. [Sounds when a hardware error is detected, PROBE Preheater Status Indicator (white lens cap) 1-10 Audible Alarm Figure 1-6 controls audible alarm sound level. Loosen locking nut Adjustment Screw before turning adjustment screw; tighten locking nut after adjustment is completed Temperature Figure -7_ | Selects assay temperature Controller: 30°C~37°C Toggle Switch ‘AIRStatus Figure 1-8, | Displays status of reaction tray heater. Indicator Figure 1 (orange lens cap) AIR REACTION TRAY or INDICATOR HEATER STATUS reel Off Heater is off. Reaction tray temperature may be above “set point.” Figure 1 Figure 1-9 Continuously lit Heater is on constantly. Reaction tray temperature is below “set point.” Flashing Heater is alternately on and off to maintain reaction tray temperature at “set point.” Displays status of reagent probe preheater PROBE REAGENT PROBE INDICATOR PREHEATER STATUS off Heater is off Reagent probe temperature may be above “set point.” Continuously it Heater is on constantly. Reagent probe temperature is below “set point.” Flashing Heater is alternately on and off to maintain reagent probe temperature at “set point.” Issued: February 1989CONTROLS AND INDICATORS usY ioc INDICATOR RELEASE, Bar Figure 1-5 DISK DRIVE ASSEMBLY oO Figure 1-6 AUDIBLE ALARM ASSEMBLY Issued February 1989 mnCONTROLS AND INDICATORS aoear'e Figure 1-7 TEMPERATURE CONTROLLER ASSEMBLY aun stavus. INDIcATOR iNotcaTon Figure 1-8 HEATER STATUS INDICATORS 12 Issued: February 1989DETAILED DESCRIPTION DETAILED DESCRIPTION The major assemblies that comprise the Technicon RA-1000 system are identified in Figures 1-9 and 1-10 For descriptive purposes, these assemblies are discussed in the following functional groupings: Reagent and Sample Delivery, Analytical Processing, System Control and Data Handling, Operator Interface, and Electrical Power Distribution REAGENT POSITIVE DISPLACEMENT REAGENT TRANSFER POMP ASSEMBLY (MECHANISM ASSEMBLY REAGENT/SAMPLE PERIPUMP ASSEMBLY ‘aun msecton ano _/| FUSES, FS, F5,AND FS Disk onive SAMPLE Positive ASSEMBLY. DISPLACEMENT PUMP E> ASSEMOLY canD cage ‘CONTROL PANEL SAMPLE TRANSFER, Intenrace MECHANISM ASSEMBLY ASSEMBLY. Fuse F? REAGENT TRAY ‘TURNTABLE SAMPLE TRAY DRIVE ASSEMBLY ‘TURNTABLE DRIVE ASSEMBLY covonmerc REACTION TRAY LED ALARM MODULE impicatons wren'c ‘TooGLe SwrrcH AIR STATUS (TOP) ‘TeMpeRATURE ‘AND prose STATUS Contaotten (sorrow inpicaToRs ‘ASSEMBLY Figure 1-9 LOCATION OF MAJOR ASSEMBLIES (FRONT VIEW) as. Power THANSFORMER POWER SUPPLY AND WARNESS, Supply FUSES AIR PUMP si) Assewaty sa)” FLLF2 ASSEMBLY ‘auorwie ‘ASsemaLy onrorr Gincurr BREAKER Powe Sorry as. 32) Figure 1-10 LOCATION OF MAJOR ASSEMBLIES (REAR VIEW) Issued: February 1989 113Reagent and Sample Delivery ‘The purpose of the Reagent and Sample Delivery function is to quantitatively transfer a specific volume ‘of reagent or sample from its respective tray position into.a reaction tray cuvette Reagent Delivery. ~The reagent delivery sequenceis as follows: Step 1. The reagent tray is rotated to position the appropriate reagent container at the Reagent ‘Tray Aspiration Station. See Figure 1-11 The reagent tray holds a maximum of 14 reagent containers, each of which is identified via the Reagent Tray Configuration. The reagent tray and the Reagent Tray Turntable Drive Assembly are keyed to establish the position of each reagent container. Subsequently, a5 ‘the reagent tray is rotated, the location of each reagent container is tracked using an ‘optical sensing device. When the required reagent container is at the Reagent Tray Aspiration Station, reagent tray rotation is stopped. REAGENT /SAMPLE PeRiPuMe sampce ASSEMBLY pe agenr REAGENT PROBE SYRINGE SYRINGE ARMMASSEMBLY SAMPLE PROBE ‘ARM ASSEMBLY REAGENT TRAY ASPIRATION ‘SawPLe TAAY STATION Sepnarion RESERVOIR CUP RESERVOIR CUP SAMPLE DISPENSING REAGENT OWEN STATION Starion Figure 1-11 REAGENT AND SAMPLE DELIVERY 114 Issued: February 1909Step2. Step 3. Step. step 5. REAGENT AND SAMPLE DELIVERY The Reagent Probe, which is mounted on the Reagent Probe Arm Assembly, is raised out of its RANDOM ACCESS FLUID reservoir cup and rotated to a position over the Reagent Tray Aspiration Station The Reagent Probe Arm Assembly is moved by the Reagent Transfer Mechanism Assembly via two d-c drive motors: one for vertical motion, and one for horizontal motion. Individual optical sensing devices are used to monitor the following probe positions: © Vertical Drive Motor Sensor 1 Upposition 5 Downposition © Horizontal Drive Motor Sensor [J RANDOM ACCESS FLUID reservoir cup Reagent Tray Aspiration Station Gl Reaction Tray Reagent Dispensing Station As the Reagent Probe is lowered toward the reagent container, the Reagent Syringe aspirates an air bubble (Figure 1-12, View A) that maintains the integrity of the first reagent aliquot Using a bidirectional stepper motor, the Reagent Positive Displacement Pump Assembly drives the Reagent Syringe that precisely aspirates and dispenses reagent. Depending upon the chemistry, there can be one or two reagent additions. The volume of reagent used for the first reagent addition (between 5 ul and 400 pl) is determined by the %RGT VOL chemistry parameter. When a second reagent addition is required, its volume (between 30 pL and 330 ul) is determined by the 2RGT VOL chemistry parameter. To prevent overfilling of the cuvette, the sum of two reagent additions cannot exceed 450 pl. The volume of reagent aspirated or dispensed is determined by the distance that the piston* moves within the syringe barrel. With respect to the %RGT VOL and 2RGT VOL chemistry parameters, this volume is expressed as a percentage of the total distance that the piston can travel within the syringe barrel; that is, the percent stroke. A 100 % stroke of the reagent syringe piston aspirates/dispenses 500 nL of reagent. To determine the percent stroke required to aspirate/dispense a specific reagent volume, use the following expression: REAGENT VOWUME (xl) PERCENT STROKE = %RGT VOL or 2RGT VOL = /OL or 2RGT VOL ate 100 When an operating error is detected for the Reagent Positive Displacement Pump Assembly, an audible alarm is sounded, and the message RPMP ERR appears on the LED Display and is printed out by the Printer. ‘As reagent is aspirated (Figure 1-12, View 8), air bubbles are injected into the Reagent Probe to maintain a uniform thin film of RANDOM ACCESS FLUID on the inner probe walls and to facilitate even heat transfer when the reagent enters the reagent preheater (Step 6) Air bubbles are generated by the Air injector and Bracket Assembly using pressurized a {(Slb/in) supplied from the Air Pump Assembly Under control of the Ar Injection PC Board Assembly, the two pinch valves on the Arr Injector and Bracket Assembly form an air bubble in the following three steps that begin with both pinch valves closed: 1) Pinch Valve 1 ‘opens to admit a slug of pressurized air; 2) Pinch Valve 1 closes to entrap the pressurized air slug: and 3) Pinch Valve 2 opens to release the pressurized air slug into the reagent probe As the Reagent Probe is raised out of the reagent container, a large air bubble is injected to ‘expel any reagent lodged in the airline. + Thesyringe paton se reterred tat the Plunger and Tip Assembly. Issued: February 1989 115REAGENT AND SAMPLE DELIVERY. veayeig 1wa6eay, ‘rau pavestdse uobeass lssued Febrvary 1989 annaiuae awys/ingovad ous ain sss200¥ NOONYE Ny anna wie Figure 1-12 ASPIRATION AND DISPENSING OF REAGENTREAGENT AND SAMPLE DELIVERY Step6. When the Reagent Probe Arm Assembly reaches the up position, the Reagent Syringe aspirates sufficient air to move the air-segmented reagent stream within the reagent preheater coil (Figure 1-12, View C), To ensure a uniform reagent temperature, the reagent stream is moved back and forth within the reagent preheater coil by the Reagent Syringe, which cycles three times in each direction to alternately dispense and aspirate an appropriate volume of air ‘The reagent preheater raises the reagent temperature approixmately 0.5°C above that of the assay temperature, 30°C or 37°C, as applicable. Electrical power to the reagent preheater is regulated by the Temperature Controller Assembly, Step7. After waiting stationary over the Reagent Tray for approixmately five seconds, the Reagent Probe is rotated to a point directly above the Reaction Tray Dispensing Station and then is lowered into the cuvette below. Step8. While reagent is being dispensed (Figure 1-12, View 0), additional air bubbles are injected into the Reagent Probe to maintain a uniformly thin film of RANDOM ACCESS FLUID on the inner walls and to aid in expelling reagent. Concurrently, the Reagent/Sample Peripump ‘Assembly is actuated to supply RANDOM ACCESS FLUID that flushes any remaining reagent from the probe. The small volume of RANDOM ACCESS FLUID dispensed into the cuvette settles below the optical window. Step9. The Reagent Probe is raised out of the cuvette and rotated toward the reagent tray to obtain the next reagent. If another reagent delivery is not required or if the next cuvette is defective as determine by the QC Scan Check, the reagent probe stops and lowers into its RANDOM ACCESS FLUID reservoir cup, ‘The OC Sean Check i pectormed via 3.0 and escnbedin Section Il, COMPUTER COMMAND CODES. Sample Delivery. — the sample delivery sequence for the first assay is initiated approximately 45, Seconds after reagent is dispensed into the first reaction tray cuvette. This delay provides sufficient time to obtain reagent blank readings for the first reagent. The sample transfer sequence is as follows: Step 1. The sample tray is rotated to place the next sample cup at the Sample Tray Aspiration Station. See Figure 1-11 \fmuloae stration ae requrad from the same cp, the sample tray ncerec um the an spravensabraee ‘The 30-position sample tray is mounted on the Sample Tray Turntable Drive Assembly that, rotates the sample tray one sample cup position ata time Step2. The Sample Probe is raised from its RANDOM ACCESS FLUID reservoir cup and rotated to a position over the Sample Tray Aspiration Station. ‘The Sample Probe Arm Assembly 1s moved by the Sample Transfer Mechanism Assembly that operates in the same manner as previously described for the Reagent Transfer Mechanism Assembly. When the Sample Probe Arm Assembly cannot be positioned Properly, the message SMP PROB appears on the LEO Display and is printed out by the Printer. lesued: Febuary 1989) 417REAGENT AND SAMPLE DELIVERY Step 3. Steps Steps. Steps. Step7 steps ‘As the Sample Probe is lowered toward the sample cup, the Sample Syringe aspirates an air bubble (Figure 1-13, View A) that maintains the integrity of the first sample aliquot Using a bidirectional stepper motor, the Sample Positive Displacement Pump Assembly drives the Sample Syringe that precisely aspirates and dispenses a fluid volume between 2 ul and 30 ut as specified by the chemistry-specific %SMP VOL parameter. ‘A100 % stroke of the sample syringe piston* aspirates/dispenses 50 ul of sample. To determine the percent stroke required to aspirate/dispense a specific sample volume, use the following expression: PERCENT STROKE = SAMPLE VOLUME (pL) , so oul When an operating error is detected for the Sample Positive Displacement Pump Assembly, an audible alarm is sounded, the message SPMP ERR appears on the LED Display and 1s printed out by the Printer. ‘The required volume of sample is aspirated (Figure 1-13, View B). A thin, uniform film of RANDOM ACCESS FLUID prevents sample contact with the probe surfaces, ‘The Sample Probe is raised from the sample cup. ‘After waiting stationary over the Sample Tray for approximately five seconds, the Sample Probe is rotated to the Reaction Tray and lowered into the cuvette positioned at the Reaction Tray Sample Dispensing Station. See Figure 1-11 While sample is being dispensed into the cuvette (Figure 1-13, View Q), the ReagentSample Peripump Assembly is actuated to supply RANDOM ACCESS FLUID that flushes any remaining sample from the probe. The RANDOM ACCESS FLUID dispensed into the cuvette Ge, reagent and sample probe washings) settles below the optical window (Figure 1-13, View! The Sample Probe is raised and rotated toward the sample tray to obtain the next sample. If another sample delivery is not required or if the next cuvette is defective as determined by the QC Scan Check, the Sample Probe stops and lowers into its RANDOM ACCESS FLUID reservoir cup. + Thesjinge ston sreferred tos the Plunger and Tip Assembly 118 Issued: February 1909,Y 9 5 wong asin uo : 3 pans sutton qurta 2 5 ney ‘71949 gaausig ayvs ony 37242 amasia inaovau — haavat nous Sowa mods thats SS Wooo ‘int Soaoav woah g 5 g Figure 1-13 ASPIRATION AND DISPENSING OF SAMPLE aeows stays — anoauag snawsiingovad wows aint nae ‘ssagov noONYd sowiuas sansANALYTICAL PROCESSING Analytical Processing The analytical processing function is performed by the Reaction Tray, the Reaction Tray Module, and the Colorimeter Assembly. Reaction Tray. ~ The Reaction Tray contains 100 individual cuvettes in which the reagent and sample are mixed and incubated, and the resulting absorbance is measured. After all cuvettes are used, the feaction tray must be replaced. Before operation, the quality of each cuvette can be checked via command code 30 . When a cuvette is not acceptable (ie, defective or previously used), its position is stored in memory and the cuvette is not used. For details concerning use of this command «ode, refer to Section Il, COMPUTER COMMAND CODES. Reaction Tray Module. - the Reaction Tray Module performs the following two functions: 1)it maintains a constant temperature environment at 30°C or 37°C, as selected by the user, and 2) it ‘transports the Reaction Tray through each step of the assay work cycle. The Reaction Tray Module maintains the assay temperature using a heated-air bath produced by an electrical heater and a fan. Electrical power to the reaction tray heater is regulated by the Temperature Controller Assembly. The Reaction Tray is locked in place on the keyed Reaction Tray Drive that is rotated incrementally by a ‘Stepper Motor. A belt and pulley arrangment links the Stepper Motor and Reaction Tray Drive, Position feedback is obtained from an optical sensing device that monitors the following reaction tray drive Positions which are expressed in terms of cuvette position: © Cuvette 1 (Home position) © Cuvette 25 (first 1/4-turn tray rotation CCW from Home position) © Cuvette 50 (second 1/4-tur tray rotation CCW from Home position) Cuvette 75 (third 1/4-turn tray rotation CCW from Home position) Al reaction tray cave orientations ave with reset 10 the feagemt Dupersing Staton The React Tay anc Reson Tay Onve are Heyed 1a thats home iniemion obtained wher Givetie | wt the Reagent Oapering Seton Lkewre, the St ‘vatum rataton Cow ss cetected when cuvette 75s ot the Reagent Opening sation When the Reaction Tray Drive cannot be positioned properly, an audible alarm is sounded, and the ‘message RCT ERR appears on the LED Display and is printed out by the Printer. ‘The Reaction Tray Module work cycle is repeated continuously until the last assay is processed, The 15- second reaction tray work cycle is comprised of four elements: 1) receive reagent and/or sample, 2) rotate reaction tray drive abruptly to mix cuvette contents, 3) rotate 43 cuvettes past Colorimeter Station, and 4) position next cuvette to receive reagent or sample. When operation is initiated, only reagent is dispensed during the initial three work cycles. The first sample is dispensed during the fourth work cycle, approximately 45 seconds after the first reagent. This delay enables the system to obtain three reagent blank readings, as required The following sequence describes the initial reaction tray work cycle performed in the OPERATE Mode. ‘Assume that operation is started with Cuvette 1 at the Reagent Dispensing Station as illustrated in Figure 1-14, View A Stept Reagent for the first assay is dispensed into Cuvette 1. Note that sample is not dispensed at thistime. See Figure 1-14, View MGinate 1 defective ms detemined by the QC Scan Check no feagent is dispensed and the Reagent Prabe remy he AatooM access FLUD rereton cap Then, the trench troyworkjcesscompetedntranenpty Covete 1 cuvete! 1 defece but Covet? accepts regent fs the ft say ‘dspenseu mt cuvete? mg econdracton tay won ue 1-20 Issued February 1989save BIsPeNSING REAGENT DISPENSING Stavion STATION, ey ° coLonmerer Staion’ starr READ A Cuvette 1 positioned at Reagent Dispensing Station same DISPENSING Dispens REAGENT DISPENSING STATION. ° coLonmerer Staion starr ii Cc... Tray indexed abruptiy 28-cuvette postions (CCW for mixing. same REAGENT o1sreNsi Bisrensine __Staviow USTENSING STATION Reap (> coLORIMETER Forty-three Cuvettes indexed Station past Colorimeter Station ANALYTICAL PROCESSING REAGENT o1sPeNsiNe Oo Reagent dispensed into ‘Stanowe Te" Guverte 1 sampe BIPENSING REAGENT oISPENSING Stanion”_ Sranion D.., Tray positioned prior {0 obtaining optical readings. SAMPLE REAGENT DISPENSING Bisrensinc STATION STATION start READ ° coLonmeren Stanion F Reaction Tray slewed to position Guvette 2 at Reagent Dispensing ‘Station, Figure 1-14 REACTION TRAY WORK CYCLE - ADDITION OF REAGENT ONLY Issued: February 1989ANALYTICAL PROCESSING Step2. The Reaction Tray is rotated abruptly 28 cuvette positions counterclockwise to mix the cuvette contents (Figure 1-14, View C), Step3, The reaction tray is slewed (a rapid mechanical motion) six positions clockwise prior to taking optical readings. The last cuvette to be read is placed 43 cuvette positions (clockwise) from the Colorimeter Station. In Figure 1-14, View D, Cuvette 1 is placed 43 cuvette positions from the Colorimeter Station, Step4, Forty-three (43) cuvettes are indexed (a slow mechanical motion) smoothly to the Colorimeter Station. After each index movement is completed, time is allowed for any fesidual tray motion to cease before an optical reading is taken at the Colorimeter Station. ‘An optical reading is obtained only when required by the chemistry program. For ‘additional details, refer to paragraph titled “Colorimeter Assembly,” page 1-25. In Figure 1-14, View E, Cuvette 1 is the last cuvette to be indexed to the Colorimeter Station Step5. The reaction tray is slewed until the next cuvette to be used is positioned at Reagent Dispensing Station. In Figure 1-14, View F, Cuvette 2 is positioned at the Reagent Dispensing Station. As previously stated, the addition of sample occurs three reaction tray work cycles after the corresponding reagent is dispensed. Assuming that reagent is dispensed into Cuvette 1, Figure 1-15 shows the sequence for the fourth reaction tray work cycle during which sample is dispensed into Cuvette 1 and reagent is dispensed into Cuvette 4. This sequence is identical to that shown in Figure 1-14, except that the cuvette positions have been incremented by 3. When required by the chemistry program, the sécond reagent is dispensed at a time determined by the 2RGT DELAY parameter, which is measured with respect to sample addition, The 2RGT DELAY time is reviewed by the operator when the OPERATE mode is entered and can be any interval between Omin 15s and 5 min 0 s, in 15-5 increments. The specified 2RGT DELAY is applied to all two-reagent chemistries on the reagent tray configuration. The following sequence describes the modified reaction tray work cycle used to add a second reagent. For illustrative purposes, assume that 2 second reagent is to be added to cuvette 1 during the reaction ‘tray work cycle that immediately follows addition of the sample (ie, second reagent delay time is 15 seconds). Step 1, At end of the preceeding reaction tray work cycle, the cuvette requiring a second reagent ‘addition is positioned at the Reagent Dispensing Station. As illustrated in Figure 1-16, View A, Cuvette 1 is position at the Reagent Dispensing Station. (if a second reagent addition was not required, Cuvette 5 would have been Positioned at the Reagent Dispensing Station.) ‘Step2__The appropriate volume of second reagent (between 30 pl and 330 pl) is dispensed There iso addition of sample at this time. Step3. The Reaction Tray 1s indexed 28 cuvette positions to mix the liquid contents of each cuvette aspreviously described Step4 The reaction tray 1s slewed (counterclockwise of clockwise) until the cuvette positions are identical to those at this same time during the last reaction tray work cycle This step restores the cuvette processing order that was interrupted in Step 1 In Figure 1-16, View , the reaction tray is slewed three cuvette positions clockwise to place Cuvette 4 at a point 43 cuvette positions from the Colorimeter Station Step5. _In turn, 43 cuvettes are indexed to the Colorimeter Station as previously described As shown in Figure 1-16, View E, Cuvette 4 is the last cuvette to be indexed to the Colorimeter Station, (Continued on page 1-25) 122 Issued: February 1989SAMPLE DISPENSING REAGENT DISPENSING STATION STATION start o coLonimerer SPATION A CCuverte 4 positioned at Reagent Dispensing Station, and Cuverte 1 positioned at Sample Dispensing Station, DISPENSING STATION. REAGENT DISPENSING STATION stant ReaD wx ‘eB Cc Reaction Tray indexed abruptly 2B-cuvette positions (CCW) for ‘mixing SsaMre DISPENSING REAGENT DISPENSING STATION’ STATION start ° STATION E Forty-three Cuvetes indexed past Colorimeter Station, ANALYTICAL PROCESSING sampce DISPENSING REAGENT DISPENSING StaTION STATION stant READ Reagent canensed into Stanow Cuverte 4, and sample dispensed into Cuvette 1 C aur Hina senaaye oererene ieee recon (i D coXonmeren Feacion Tn ooitonnd pr sexe eben Set cae sue SEENEma neaceur wens camer sesege stant ReaD cotonmeren Reaction Tray slewed to position Cuverre 5 STATION ‘a1 Reagent Dispensing Station and Cuvette 2 at Sample Dispensing Station O ? Figure 1-15 REACTION TRAY WORK CYCLE ~ ADDITION OF REAGENT AND SAMPLEANALYTICAL PROCESSING SAMPLE DISPENSING REAGENT DISPENSING STATION” STATION. staRr READ mix v4 coLORMeTER STATION’ A Cuvette 1 positioned at Reagent Dispensing Station, O same DISPENSING STATION REAGENT DISPENSING STATION stant READ 9 Reaction Tray indexed abruptly sranion 2éscuvette positions (CCW) for Fn mixing. saMeue DISPENSING REAGENT DISPENSIN STATION”. Sravion’ STENSING starr reap Forty-three Cuvettes indexed stanon past Colorimeter Station sameLe DISPENSING STATION REAGENT DISPENSING STATION x ‘stanr READ mix B ? Reagent dispensed into coLonmerer Rood Starion samp DISPENSING REAGENT OISPENSING STATION StaTion’ stant Reap E D ne to obtaining optical readings DISPENSING STATION REAGENT DISPENSING S1ATION F Reaction Tray slewed to position Cuverte at Reagent Dispensing Station and Cuvette 2 Sample Dispensing Station, cousnimeren, 5 STATION Figure 1-16 REACTION TRAY WORK CYCLE - ADDITION OF SECOND REAGENT 1-24 Issued February 1989ANALYTICAL PROCESSING Step6. The reaction tray is slewed until the next cuvette to be used is positioned at Reagent Dispensing Station. In Figure 1-16, View F, Cuvette 5 is positioned at Reagent Dispensing Station. ‘After the last sample is dispensed and the Sample Probe returns to its reservoir, the system enters the IN PROCESS submode. At this time, the operator can generally start another run. However, a work list containing calibration, RB rate, and or reagent blank samples must be completely finished (READY indicator lighted) before another work list can be started. This delays ensures that CAL FACT, RGT RATE, ‘and RGT BUNK values are updated before patient samples are run. Any premature attempt to start ‘another run is inhibited, and a WAIT message appears. During the IN PROCESS submode, the same set of cuvettes is processed during each reaction tray work cycle. When the last assay is completed and the results for the last sample are printed, the READY mode isentered, Colorimeter Assembly. Figure 1-17 provides a diagram of the Colorimeter Assembly. Light from a ‘tungsten-halogen lamp is focused onto one of eight filter wheel positions mounted on a stepper-motor driven filter wheel. The eight positions are occupied by six interference filters (340 nm, 380 nm, 405.nm, 5001nm, 550.11m, and 600 rm) and two plugs (dark-current readings). All light that passes through an, interference filter is split into two paths, each of which is subsequently focused onto a separate silicon photodetector. The sample light path passes through the reaction tray cuvette; the other light path provides @ continuous air reference. The amplified output from each photodetector is routed to the Data Acquisition PC Board Assembly When an optical reading is required as determined by the chemistry program, the filter wheel is rotated to the appropriate position and the amplified analog outputs from the sample and reference photodetectors are processed by the Data Acquisition PC Board Assembly. If an optical reading is not Fequired, the filter wheel position remains unchanged and the colorimeter analog outputs are not processed f cuverte arte eee / Figure 1-17 SCHEMATIC DIAGRAM OF COLORIMETER ASSEMBLY Issued: February 1988 1-25ANALYTICAL PROCESSING Dark Current Optical Readings Dark current readings are taken using filter position 7, which contains a light blocking plug Consequently, the dark current readings represent the output of the sample and reference Photedetectors with no light present and provide an electronic baseline for each detection channel Using command code 2 3. , the operator should obtain updated dark current feadings before air filter readings are taken. The system automatically takes dark current readings before processing each work lst. Air Filter Optical Readings When air filter readings are taken, each interference filter is, in turn, rotated into the colorimter light path. By protocol, no reaction tray is loaded so that the air filter readings represent the absorbance obtained with oniy a filter in the sample channel light path (ie, no cuvette). The air teading measured for each filter is used for reference purposes and is indicative of overall colorimetric performance. Using command code 2 4 , the operator should obtain updated air filter readings daily, especially before performing the QC Reaction Tray Check via command code 3 To simplify calculations within the system, a value of 3.0000 is added to every colorimetric reading. Subtraction of the associated air filter reading from this system-based value provides an “air. corrected” value in the usual absorbance units (A). All absorbance data provided via printer formats 2.and3(6 0 ) are in system-based absorbance terms, Optical Readings Obtained Before Sample Addition As previously discussed, there are three reaction tray work cycles between reagent and sample additions. The first work cycle provides an opportunity to determine the reagent baseline (RBL) at 4 secondary wavelength specified via the FILTER 2 chemistry parameter. This optical reading is identified as RBL1. If a bichromatic test is not being processed, the RAL! reading is not taken. During the second and third work cycles, the reagent baseline (RAL) is determined at the primary wavelength specified via the FILTER P chemistry parameter. These readings are identified as RBL2 and RBL3, respectively, For all tests, the air-corrected RBL3 reading is compared to the RBL LOW and RBL HIGH (direct. methods only) limits. if the air-corrected RBL3 reading is not within these limits, the reported test result is annotated by an “R." For endpoint tests only, the difference between the RBL3 and RBL2 is compared with an end- point limit (EP LIM). If the difference exceeds the EP LIM, the test result is not reported and is replaced by XXXXX L. Optical Readings Obtained After Sample Addition After sample addition, the number of optical readings obtained is dependent upon the type of assay (ie, zero-order rate, first-order rate, endpoint, etc). For complete details concerning the Optical readings taken for each assay type and the calculations performed to obtain the reported result, refer to Section II, CALCULATION OF RESULT. Issued: February 19893Y STEM CONTROL AND DATA HANDLING System Control and Data Handling Figure 1-18 provides a block diagram of information flow within the Technicon RA-1000 system. The CPU & Memory VSI PC Board Assembly and associated interface assemblies perform all system control and data handling functions except for temperature regulation. This is performed by the Temperature Controller Assembly. The temperature Controller Awsembly provides alarm status Information othe CPU & Memory VSI PC Board Asemby CPU & Memory VSI PC Board Assembly. - the CPU & Memory VSi PC Board Assembly (Figure 1-19) contains 4k bytes of Programmable Read-Only-Memory (PROM) and 64k bytes of Random ‘Access Memory (RAM). PROM provides the initial instructions required to perform the start-up diagnostic tests and to load the program from disk into RAM The program consists of an organized sequence of instructions for controlling system operation and for data processing. The program is executed by the Central Processing Unit (CPU) which is based on a 8085A-2 microprocessor that performs the necessary logic, arithmetic, and timing operations Fundamentally, logic decisions originating from the CPU are converted by the applicable interface assembly into specific control signals that initiate action by the peripheral device (e g, colorimeter filter wheel, reaction tray drive, etc). Conversely, the peripheral device provides position feedback data that ‘are converted by the interface assembly into status information for the CPU. ‘A Disk Controller, type 8272A, provides the interface between the CPU and the Disk Drive Assembly. Communication between the CPU and the peripheral devices is accomplished using the following PC Board Assemblies: Serial VO PC Board Assembly, A.C. Motor Control PC Board Assembly, Stepper Motor Control and Front Panel PC Board Assembly, and Data Acquisition PC Board Assembly. All of these PC Board Assemblies are located in the Card Cage (Figure 1-19} ‘There are two switches mounted on the CPU & Memory VSi Board Assembly: a red, RESET push-button switch and a DIP program switch. When pressed, the red RESET push-button switch (51) begins the system initialization routine; the program is loaded from disk into RAM, and the start-up diagnostic tests are performed. The reset function can be requested remotely via the control panel RESET push-button switch. The DIP program switch contains eight individual configuration selector switches that are set at ‘the factory and should not be changed unless otherwise directed. The correct switch positions are listed in Figure 1-19. If it is necessary to change switch positions, refer to Section IV, OPERATION. See Paragraph titled “Configuring the CPU & Memory VSI PC Board.” Serial HO PC Board Assembly. - The Serial VO PC Board Assembly has three RS-232-C* compatible Serial VO channels to provide an interface between the CPU and the following peripheral functions: © IS Module (when used) © Technicon iDee system © Laboratory Information Service (Lis) Interface The following LEDs indicate the presence of the specified d-c voltages at the PC Boara Assembly DS1 (+15. V de), 082(~ 15 Vdc), and DS3( + SV.de) + nterface Between Date Terminal Equipment ElectronisindustnesAsvociaton Standard 16 Data Communication Equipment Employing Serial Binary Data Interchange 2c Issued: February 1969SYSTEM CONTROL AND DATA HANDLING ze 1 1 ' I 1 I 1 | I 1 | ! ie 4 3 Figure 1-18 INFORMATION FLOW BLOCK DIAGRAM 1-28 ‘issued. February 1968‘SYSTEM CONTROL AND DATA HANDLING. LEGEND DIP PROGRAM SWITCH S2 Atta designator SMITCH* FUNCTION —_swITCH POSITION Indicator lamp) Connector (emste © 1 Nor Uses on Connector (rate) ] 1 2 DikDensy oF Part Nomber 2 3 Dee Option On= Disabled Switch Off = Enabled Switen | 3 4 Ise option On= Disabled Cabie | Oft » Enabled 45 DiskSize On 5 6 Starvup Diagnostics On | § 7 Babugan Rest On 7 8 System /Debup Boot On ‘thor O though Yor 1 Uvouah 8 =n Ee RN es - ee TE) gg BZ” Si a chu & MEMORY VSLP.C.BO_ASSY. (v4) PHIDE.148-01 oa FCS so eset om omen) neo TERS my 7 Tea Tauren ns Terre woroR conrad 8 FRONT PANEL C80 ASSY.(A1) P10 Ga we TORfaeriONTRATE EEL japrinten PRNTER SV GDionetenraven POMDRESET poe TOPRINTER ser wmnceuassys en ten i Ore maura te al BS, > | SREB oo ey eae Z Figure 1-19 CARD CAGE PC BOARD ASSEMBLIES, Issued: February 1989 1-29‘SYSTEM CONTROL AND DATA HANDLING A.C. Motor Control PC Board Assembly. - The A.C. Motor Control PC Board Assembly provides an interface between the CPU and the following peripheral functions: © Sample Transfer Mechanism Motors © Reagent Transfer Mechanism Motors © Sample Turntable Drive Motor © Reagent Turntable Drive Motor © Peristalitic Pump Motor # Airinjector Solenoids LED 051 indicates the presence of +5 V de at the PC Board Assembly Stepper Motor Control and Front Panel PC Board Assembly. - The Stepper Motor Control and Front Panel PC Board Assembly provides an interface between the CPU and the following peripheral functions. The corresponding interface control device is provided parenthetically. '* Filter Wheel Stepper Motor (Peripheral Interface Microcomputer, type 87418) © Reaction Tray Stepper Motor (Peripheral interface Microcomputer, type 8741A) * Reagent Positive Displacement Pump Stepper Motor (Peripheral interface Microcomputer, type a7aia) * Sample Positive Displacement Pump Stepper Motor (Peripheral Interface Microcomputer, type 8741) © Printer Assembly (Peripheral interface Microcomputer, type 8741A) ¢ LED Display (Programmable Peripheral Interface, type 82448) © Keypad (Programmable KeypadDisplay interface, type 8279) ‘The following push-button switches are mounted on the PC Board Assembly: 1 resets the interface control device for the Printer Assembly, and S2 resets the interface control device for the Filter Wheel ‘Stepper Motor, and the Reagent and Sample Positive Displacement Pump Stepper Motors. LED DS! indicates the presence of +5 dc at the PC Board Assembly Data Acquisition PC Board Assembly. - The Data Acquisition PC Board Assembly converts analog data from the sample and reference colorimeteric channels into a digital format that can be processed by the CPU. The data acquisition function communicates with the CPU via a Programmable Peripheral Interface, type 8255. The following LEDs indicate the presence of the specified dc voltage at the PC Board Assembly DS! (+5 Vdo), DS2 (~ 15V de), and 053 (+ 15 V de) 1:30 usued: Febraney 1989