ACL 3000 Coagulation System Operator's Manual = P/N 80000-06 QS instrumentation Laboratory Instrumentation Laboratory SpA - Viale Monza, 338 - 20128 ManoOperator's Manual Text Ml PIN981S9-26 mM Rlov.3 mM April 1903, ‘This publication and any and all materials (including software) concerning the products ot L's Coagulation Systems are of proprietary natuxe and ave communicated on a strictly confiden- tial basis; hey may notbe reproduced, recorded, stored in a revieval system, transmitted or dlisclosedin any way and by any means whatsoever, whether electionic, mechanical hrough pethecopying or otherwise, without IL's prior witien consent Information contained herein s believed by IL to be accurate:In any event, no responsibly, \heiner expressor implied, s assumedhareby by ILfororinconnection withthe use thereat, oF for intingomont of any thid part rights which might arise therettom., or trom any representation or omissions contained therain Information is subject to change andior updating without any noticeContents 1 General Information 10 1 General Information Product Use = Measured Parameters Expression of Results. Instrument Description .. Principle Components Additional Features Procedural Limitations Reverse Display... Bar Code Scanner 2 Installation 2.0 INSPECHON eerste 21 Installation Requirements . 2.41.1 Ambient Conditions ... 2.1.2 Spatial Requirements 21.3 Electrical Requirements. 2.2 Instrument Unpacking 2.3 Instrument Parts Mounting 24 Switch On : 3 Operation 3.0 Preparation of the instrument 3.1 PT-Fibrinogen : 3.2 33 34 35 TTAPTT 2.6 Extrinsic Pathway 3.7 Intrinsic Pathway..... 3.8 Single Factors 39 Double Test 3.10 Heparin... 3.11 Antithrombin Il. 3.12 Plasminogen 3.13 -2-Antiplasmit Instrumentation Laboratory3.14 3.15 3.16 3.17 3474 3.172 3.18 3.18.4 3182 3.183 3.19 Contents Procomplex.... 3-100 Hepatocomplx .. 3-108 Proclot 3-116 Titration 3-123 PT-FIB Titration 9-123 3-192 3-138 3-138 3-140 3-142 3-445 APTT Titration... so Re-use of Partially Used Rotors Introduction | svt Operator's Actions. Rotor Loading Characteristics ‘System Precision .. _ 4° Special Programs 40 44 444 42 424 422 423 43 44 45 46 47 474 472 48 49 4.10 4104 4.10.2 4103 ait 412 4124 4122 4423 4124 4125 4.13 414 415 QQ) tostrumentation taboratory Special Programs (PROG) ... Loadiist Program... Use of the Bar Code Scanner. Cal Data Program . PT-FIB Cal Data : Extrinsic Pathway Cal Data .. Intrinsic Pathway Cal Data PT Calculation Program... Warning Program| Units Program Data Time Program Printer Status Program Printer Set Up ... Printout Format .. : Acquisition Time Program Interface Status Program Data Transmission Program. Data Transmission 1/2 ... Sample ID/Batch No. Selection Delete Sample ID/Batch No. Priming Program .. Check List Program. ‘Temperature Control... VDU Brightness Needles Position .. Maintenance Semice..... ne Reference Data Program SP Data and Plot Program Ratio Adjustment ProgramACL Operator's Manual 5 Maintenance 5.0 5A 52 53 54 55 56 Maintenance ese Daily Preventive Maintenance Weekly Maintenance... Bi-weekly Maintenance... Monthly Maintenance... Needles Adjustment Procedure . Annual Maintenance... 6 Troubleshooting 60 61 614 612 61.3 614 615 616 617 618 619 6.1.10 64.11 62 6.24 622 6.23 6.24 63 7 Specifications 7.0 744 7A2 743 TA TAS 72 73 74 75 76 77 78 Q3 instrumentation aboratory Introduction Warning : Magnatic Stirrer Fail. Flush/Optic Channel Error Halogen Lamp Fail... Printer Fail ‘Thermal Fail — Preheater Temperature out of range Peltier Temperature out of Range Master Storage Battery . = Slave Storage Battery FS282C Interface. Sensor Fail Other Warnings and Alarms esuhs <7 eauenes Printer Error Codes ..... Cycle Abort Situations . Error Codes on VDU Alarms Introduction ....... Sample Tray Positions . Sample/Reagent Rotor Position. Coagulimetric Analytical Cycles . Chromogenic Analytical Cycles . Special Tests oes Volume of Cups and Reagents Reservoirs Calibration Plasma and Sample Predilutions. Measured Parameters sone Calculated Units Flagging Limits. Output VDU and Printer Particular Indications...Contents 7.9 VDU Indications for not Calibrated Situations 7-30 7.10 Slope Curve (m) for Calibrated/Not Calibrated Situations 7-30 7.11 Intercept in Calibration Curves .. 734 7.12 Ranges for Calibration Plasma Value Insertion... 7-82 7.13 Measuring Ranges of all the Coagulimetric and Chromogenic Parametsr. 7.44 — Maximum End Time for Coaputmetic and Chromogenic Tests... : 7.45 Parameter Gorrelation . 7.16 Analytical Characteristics 7A7— Carry-over e740 718 — Lipemic Samples creer 7-40 7.19 Primary Tubes Characteristics... esses PAO 7.33 7:36 2 7-39 7:39 7.20 Instrument Characteristic . TA 7.21 Ambient Conditions .... 7-42 7.22 Electrical Requirements 7-42 7.23 Dimensions... 7-43 8 Sample Collection and Storage 8.0 Introduction... 8.1 Collection of Plasma 82 Separation and Conservation of Plasma. 83 Calibration Plasma... 9 PRE 9.0 Expendable Material 9.1 Reagent Reservoirs....... 9.2 Black Probes Assay 9.3 Sample Cups 94 Sample Tray 95 Rotors 8.6 — Magnetic Stirrer.. 9.7 Waste Tube (1 meter) 9.8 Printer Paper... 99 Sample and Reagent Tubing (1 meter) 9.10 Waste Reservoir 10 Decontamination Procedure 10.0 Introduction... 10.1 Decontamination Procedure Falowing the Analys of Highly Infectious Samples ... - QB instrumentation taboratory‘ACL Operator's Manual " Appendix A Appendix B Appendix C Addendum Warranty 11.0 General Warranty Conditions os veseeeee 1-4 114.1 IL Wordlwide Locations .... ers RS 232C General Information 1.0 RS 2326 Electronic Communications Interface 20 Main Characteristics. : 3.0 RS 232Connections RS 232C Specifications 4.0, Introduction wee 2.0 Transmission Types .. 2.1 Interface Configurations .... 22 Prog "Data Transmission"... 2.3 Prog "Interface Status” . 2.4 Instrument Configurations 3.0 Data Transmission Procedure 3.1 Communication Procedure for the IL Protocol... 3.2 Communication Sequence for the IBM Protocol. 3.3 Interconnect Cables . 4.0 Formal Description .. 441 Transmission Types .. 4.2 Reception Types... 43 Protocol Description 44 Message Description 5.1 Message Contents Description 52 X,Y, Description . 5.3 m,q, description .. 5.4 NP Description 55 —_NP-ID Description 56 — W Description... 5.7 Sample ID Descriotion CCD Barcode Scanner Setting 1.0 Introduction .. 2.0 ‘General Information at Recommendations ....... - 3.0 Changing of the Barcode Setting ..... 4.0 Enabling of Addition Barcodes 5.0 Checking the Scanner ............ 51 Checking of the Enabled Code(s) 5.2 ‘Checking of the not Enabled Codes. 53 Checking of Alphanumeric Codes... 54 ‘Checking of the Scanner Timeout Software Revision 0.7 Q) instrumentation taboratory1 General Information 1.0 General Information This manual contains the procedures to operate, maintain and troubleshoot the ACL System (Figure 1-1). Personnel responsible for operating and maintaining the instrument should read and understand the included material prior to use. This manual should be kept near the instrument or in a suitable location for reference as required. This section includes a general description of the Instrumentation Laboratory ACL. Covered material includes product use, methodology, additional features and procedural limitations. 1.1. Product Use Instrumentation Laboratory's ACL System is a fully automated, high productivity analyzer for specific clinical use in coagulation and/or fibrinolysis testing. Results include both direc hemostatic measurements and calculated parameters ‘ACL System: Front View | | | | QS hstrumentation Laboratory1-2 Ganeralintormation 1.2 Measured Parameters The ACL system is capable of performing the following tests: Coagulimetric Tests + PT-FIB (Prothrombin Time and Fibrinogen Level) + APTT (Activated Partial Thromboplastin Time) - PT-FIB/APTT (three tests run simultaneously) + TT (Thrombin Time) - TTAPTT (two test run simutaneousty) - Extrinsic Pathway Factors (Vil, X,V.ll) + Intrinsic Pathway Factors (XII, XI, IX, Vill) + Single Factors (VII, X, V, 1 Xil, XI, IX, VIll: high curve and low curve factor assays: simultaneous calibration and sample analysis) Double Tests A double test facility for PT-FIB, APTT, TT and PT-FIB/APTT is also provided. Chromogenic Tests ~ Antithrombin Il ~ Heparin (high curve and low curve) - a-2-Antiplasmin ~ Plasminogen Special Tests = Procomplex ~ Hepatocomplex = ProClot 1.3. Expression of Results The ACL system displays and prints results in: = s (seconds) ~~ R (ratio) - INR (International Normalized Ratio) = % (percent activity) ~ U/ml (units/ml) = mg/dl or g/l (Fibrinogen level) The ACL measures the parameters at 37°C+1°C (98.6°F+1.8°F) at an ambient temperature from 15°C to 32°C (59°F to 89°F). At a constant ambient temperature, the ACL measures the parameters at 37°C+0.25°C.. Q8 instrumentation Laboratory‘ACL Operator's Manus! 1.4 Instrument Description ‘The ACL is a fully automatic microcomputer-controlled, microcentrifugal analyzer. The ACL™ system incorporates a video display unit (VDU) that continually displays the status of the instrument and gives instructions ‘on how to proceed. Instructions are entered into the ACL system via a membrane keyboard. ACL System: Components Dascipton Dr @ 2 e 1. Roteranco Emulsion 2.Dlutor 3. Tharmal Pent 4.vou 6 5. Cover | 6. Rotor Proheator 7. Keyboard © 8 Rotor Housing = ‘§. Sampiing Am « ‘= 10. Rinso Reservoir 11 Reagents Raservors re 12, Sample Tray D @ ( S 2 1.4.4 When a sampling cycle is initiated, the samples and reagents are ‘sequentially pipetted into a 20 place acrylic rotor (loading). Sample and reagents are mixed via centrifugal force (rapid acceleration and braking to blend reaction mixture). Measurements are made while the rotor is spinning (acquisition). ‘The results are displayed on the VDU and printed by the thermal printer. The ACL is able to perform an automatic calibration, offers a series of utility programs for the operator and is capable of carrying out a system precision quality assurance program. Principle Components The instrument is composed of the following functional Parts: = body structure + sample tray (for cups and primary tubes) ~ feagent reservoir group (macro and micro reservoirs) + waste system + sampling/dispensing systemGeneral Intormation = needle carrying arm assembly + sensors - rotor housing/measuring chamber = rotor compartment + optical measuring system (clotting and chromogenic) + microprocessor and electronics - thermal printer = video display unit (VDU) - keyboard - RS232C interface = internal cooling system Body Structure The body is a flame retardent molded structure which houses the electrical and mechanical components of the system. ‘Sample Tray ‘The autosampler uses a rotating sample tray with 20 positions each of 14.2 mm diameter (for sample cups of 14 mm and primary tubes of 13 x 75 mm) Optical sensors control that the plate is positioned and centralized correctly. The optical sensor also detects the presence of cups/primary tubes. Empty position (no cup/primary tube) will stop the loading operation of the instrument to maximize saving of rotor cuvettes. The ACL is provided with two sample trays (type 1 or 2) according to the different kind of primary tube used. Instrumentation LaboratoryAGL Operator's Manual Macro Raservolr 1. Sample tray for cups and primary tubes (13mm x 75mm) with a total filing volume of 5 ml 2, Sample tray for cups and primary tubes (13mm x 75mm) with a total filing volume of 3.5 ml. Glass Anticoagulant Drawn Blood Total Volume Volume Volume 13x75 mm 0.5 mi 4.5 mi 5 ml 13x75mm 0.35 ml 3.15 ml 3.5 mi In general, a sample cup is loaded with calibration plasma (normal poo!) in the poo! position. In addition to the pool, IL diluent (sample or factor) is loaded in the DIL position to perform calibration procedures. Reagent Reservoirs This group consists of three reservoirs marked by their respective ‘numbers of which two (Position 1 and 2) are cooled to about 15°C by ‘means of a Petter effect regulator and agitated by magnetic stir bars (macro oniy). ‘The reagent cups are of two types:‘Mero Resonvor Macro, with a capacity of 10 mi 1 PTFIB PT/FIB Extrinsic Pathway Single Factors Extrinsic Pathway PCX-HPX Procomplex - Hepatocomplex 2 APTT APTT Intrinsic Pathway Single Factors Intrinsic Pathway Proclat 3 CaCl, APTT Intrinsic Pathway Single Factors Intrinsic Pathway ProClot QU tostrumentauon taboratory‘ACL Operator's Manual 17 Micro 1 with a capacity of 2.5 ml; 2 and 3 with a capacity of 2 mi Reservoir# Reservoir Name Test 1 7 ‘Thrombin Time 2 E Enzyme for Chromogenic Tests 3 s Substrate for Chromogenic Tests The position lacking a number houses the waste/tinse cup. This cup is removable for cleaning. Waste/Rinse System ‘The ACL™ is provided with a waste/rinse system which internally connects the housing of the waste/rinse cuvette with an exit on the right side of the instrument by means of a plastic tube. Wasta/Ringa System 7 Wo ‘Sampling/Dispénsing System ‘The system consists of the following parts: a. Reference bottle This is a plastic bottle containing 500 mi of silicone emulsion which is | employed as a rinse solution and as the optical reference for the | nephelometric channel. b. Piston block This is an acrylic block with two cylinders each of which has a stainless steel piston . Electrovalve ‘Two electrovalves are housed above the acrylic block, one for each piston. They are controlled electronically and connect the pistons to | the reference bottle and the two needles mounted on the autosampling arm, QS instrumentation taboratory‘Samplng/Depansing System (General Information Eloctrovalves —) Piston Block Reterence = Emulsion Needle Carrying Arm Assembly ‘The two needles, one for the sample (S) and one for the reagent (R), are mounted on the distal end of an arm which moves radially by means of a stepping motor. The needle arm also moves in the vertical plane by means of a worm screw, driven by another stepping motor. The combination of these two movements permits the execution of the following operations: 1. Aspiration of the sample (S) and/or reagent (R) from their respective positions. Filling of the rotor with sample and reagent in the internal and external holes in the rotor cuvette. 3. Washing of the needles in the constant level waste/rinse station between reagent cups 2 and 3. In the needle block two fluidic sensors are contained to detect sample/s and reagents presence.‘ACL Operators Manual ‘Sampling Atm with Sensors tegrated in the ACL by operating them in the analytical cycles without reducing the throughput of the system. The fluid sensing cycle is executed during the incubation and before the acquisition cycle. ‘The only exceptions are the chromogenic tests where the sensor cycle has been spittin two phases: ~The first phase is carried out during the incubation time of sample loaded in the analysis compartment with the reagent (pos. 2). During this phase the presence of both the sample (sample tray) and the reagent (position 2) is checked. ~The second phase is carried out after the loading of the reagent in Position 3 and the presence of this reagent is checked.1-10 General Information The liquid sensors contro! the presence of flush (reference emulsion) = samples in the sample tray (pool, patient samples, def. plasma, dient) - reagents (in reagent reservoirs) ‘The philosophy is to give out results with a general waming in case of sensor failure and absence of liquid in the reservoirs (reagents, flush) and to indicate “no sample" for a specific cup in the sample tray without liquid. If all cuvettes in the sample tray are empty, the cycle will be aborted (after the final self check). No other warnings appear on the video nor on the printer. ‘The sequence performed during a cycle is as follows: a. selfcheck bb. liquid test c. flushing (450 j!) d. final sensor self check e. indications about the lack of reagents on the video Each time an analytical cycle is entered the liquid sensors are checked. ‘Any waming SENSOR FAIL or NO REAGENT will: = disappear at the beginning of the loading phase + appear during incubation/acquisition in case of selfcheck error or absence of reagents = remain up to the next loading phase in the following cycle. ‘An error during the initial selfcheck terminates the sensor test, but the analytical cycle continues. Test results will be presented together with a ‘warning in the status line indicating the sensor failure. No indications will bbe given about the absence of samples and/or reagents, ‘The operator will find the waming condition selecting the PROG WARNING. An equivalent message will be printed out with the results. Note: Liquid quantity aspireted for sensor check on samples and reagents is 14,1. Measuring Chamber ‘The measuring chamber is located under the cover on the right top side of the instrument. It consists of the following sections: a. Rotor holder ‘The rotor holder in the measuring chamber is an aluminium disk thermostatically controlled to a temperature of 38.520.5°C to ‘guarantee 37°C inside the cuvette.ACL Operator's Manual Rotor Prohaator ‘The 20 (position) cuvette rotors are mounted on the shaft of a stepping motor which is piloted by a bipolar-chopper circuit. The system, together with the associated decoding disk, turns the rotor and controls the positioning during the filing and measuring stages. + The normal poo! or calibration plasma is dispensed into cuvette 20 of the rotor when a clean rotor is used. ~The flush/optic reference solution taken from the 500 ml bottle housed in the instrument is generally dispensed into cuvette 19 of the rotor. ~The remaining 18 rotor cuvettes (1-18) are filled with samples and reagents. ~ Therefore, 18 is the maximum number of samples that can be analyzed simultaneously for each rotor and cycle (PT/FIB or APTT or TT) in single test mode. Rotor Preheater {It contains up to ten rotors. The rotor compartment (preheated) is molded into the working surface and permits an easy removal of the disposable rotor for analyses. The rotor preheater is thermostatically controlled. The temperature is kept at 36°-39°C. Both the rotor Support and the preheater are covered to maintain thrmoregulation. €. Optical Measuring System ‘The measuring chamber also contains the optic paths for the two readings channels: (1) nephelometric and (2) chromogenic. QQ) tostrumentation aboratory | |Clot and Chromogenic Detection System QS instrumentation aboratory General Information Chromegenie Cie chamel pee a Led | PIT rover ce Lenses sor THe vars optical ee = ne 1, Nephelometric Channel ‘The light source is a light emitting diode (LED) with a life longer than 100.000 hours. ‘The light ray is directed to the measuring cuvettes of the rotor by means of an optic fiber system (A = 660 nm). The scattered light is read at 90° with respect to the incident source by means of a solid state detector, contained below the rotor holder. 2. Chromogenic Channel The light source is an halogen lamp, from which the radiation is directed to the cuvettes of the rotor via a quartz optic fiber and a focusing system. The selection of the wavelength for analysis is effected by a narrow band interference fitter centered at 4 = 405 nm. The optical detector is mounted in the cover of the measuring chamber. ‘Therefore, readings are obtained at an 180° angle from the light souree, ‘The optic path for the chromogenic channel is 0.5 om. ‘Aremovable cover on the right side of the instrument allows the ‘operator to substitute the halogen lamp with ease.‘ACL Operator's Manual 1-19 Microprocessor and Electronics This section of the instrument is built around two Intel microprocessors type 8031. These microprocessors drive all events in the equipment, mechanical movements, aspiration and dispensing of samples and fluids, acquisition and processing of data and operator interface with input (keyboard) and output (video/printer) devices. The electronics consists essentially of six printed circuit cards contained in a frame mounted on the rear of the front panel. Three cards are assigned to the microprocessor and logic sections while the other three are used for the interface modules and the various activation controls. ‘These circuits and the subassemblies of the instruments are supplied by a switch mode power supply directly connected to the main power. Thermal Printer This is a thermal printer with 150 print dots on a 72 mm width strip. It allows a maximum of 21 characters per line in either the graphic or column mode. Tharmal Printer | Gsrmein ; |1-14 Goneral Intormation Video Display Unit This module consists of a command circuit and a 9” cathode ray tube (CRT). It quides the operator during the analytical cycle procedures and displays calibration data and patient results. it can also be used to display calibration curves. Itis a split screen system that produces both green on black (normal format) and black on green (reverse format) alphanumeric displays. The upper section (A) displays the status of the instrument and each alarm. The central section (B) displays menus, results, graph plots and instructional guidelines. The lower section (C) displays the operational instructions. Video Display Unit (VOU) ‘SECTION B SECTION ©. Keyboard ‘The keyboard with 18 membrane keys makes it possible to enter the various operating modes of the instrument. The panel is spill proof. The keys are divided into three principal groups: 1. Operative 2. Decisional 3. Numerical QQ) tostrumertation taborstory‘AGL Operator's Manual 1-15 Keyboard Operative Keys STOP Will abort all cycles at any instant, if confirmed by using the ENTER key within 5 seconds. If STOP is activated when the instrument is in the utility menu (PROG), it will return to the main menu or to a cycle in progress, (it PROG was pressed during a cycle). Ifthe STOP key is activated and confirmed with ENTER it will cause the cycle to abort. Afterwards the messages "remove rotor" and "ENTER to continue” appear on the video. Instrumentation LaboratoryGeneral Information PRT PROG Numerical Keys REMOVE ROTOR ENTER to continue Upon pressing ENTER, the test menu will be presented. If the operator does not confirm the stop command within 5 seconds with ENTER, the instrument will proceed normally. This key is used to print out under the following conditions: - When the video displays PRT, the operator may print calibration (CAL) and S.P. data if available, or sample data if automatic printout has not been selected, - Acopy of the last data generated can be reprinted while the information is stil in the instrument memory, in the results screen or in the "ready" state. PRT can always be used except during test cycles. Note: the paper advance key (orange) is under the printer cover. This key is used to select the utility programs or to exit from the utility, menu back to the test menu. This special program menu (PROG) can be activated at any time except while the system is in the acquistion phase of the cycle; although some individual programs cannot be entered during an analytical cycle. Decisional Keys ‘These keys are used to move the cursor & or in a menu display. This enables selection of the desired cycle or program, or to effect choices requested on the video display. To confirm numerical data or a decision. To cancel the last input figure, to return to a previous frame or to correct ‘a numerical entry. Numerical Keys To input all numerical data (also sample 1D) QU tostrumentation Laboratory‘ACL Operator's Manual 1-17 RS 292C Interface The instrument is provided with two RS 232C interfaces (OTE standard) for the output of data to a central computer or a personal computer. oar Pane Demons ua 1 peawe secs tis 2 seme ¥ Cape Beaton 3) aR conescANER Bar Code Reader Interface The instrument is provided with an interface for a bar code scanner which allows sample ID reading Internal Cooling System ‘Two ventilators, with an air fiter to prevent dust from entering the unit, ‘are mounted on the lett side of the instrument. A safety element prevents the internal temperature from rising to temperatures which could damage the function of the instrument by means of a two level alarm to the operator. The first level alerts the operator to the condition allowing testing to continue altough a warning will be displayed. The second level switches off the instrument. QU tostrumentation taboratory | | | i |1-18 General Information 15 Additional Features Standby Status Ifthe instrument is left on for a period of more than 30 minutes without operator action the instrument passes into the standby status. In this condition the video display is dimmed (low light) and a particular display is presented. In this condition all motors are disactivated to reduce power consumption and the LED light source is switched off, A priming cycle is automatically performed every 30 minutes, when the instrument is in standby mode. Operating the ¥ key as indicated on the video, the display returns to normal brightness (the LED light source is switched on) and shows the ‘main menu unless standby occurred with sample results on the screen in which case the display shows these results. Note: if the instrument was in a utility menu (PROG), or in a results frame, at the time the Stanaby status started the activation of it will cause the display to show the condition (menu or results) present before entering PROG. End of the Cycle At the end of each analytical cycle a 3-beep signal will inform the ‘operator of the completion of the cycle. Power Loss ‘The ACL contains a non-volatile memory to retain the data base in the ‘event of a power interruption. The retained data is listed in the following table. QE instrumentation aboratoryACL Operator's Manual 1-19 Default Values at Initial Power On or after NVRAM Initialization Date and Time Calibration Not calibrated Isl 1.000 Ref. Values. PT =120 APTT=300 TT =120 INR Off Autocal On Unit. Temp =°C FIB = mg/dl Printer Status Printout Format Fib ON Interface Statust Protocol IL Baud rate 9600 Char Length 7 bits Parity none Stop bits 1 Interface Status 2 Protocol IL Baud rate S600 Char Length 7 bits Parity none Stop bits 1 Data Transmission 1 Off (BATCH ID/SAMPLE ID OFF) Data Transmission 2 Off (BATCH ID/SAMPLE ID OFF) SP. No Data When power returns after an interruption the instrument carries out a number of checks including the temperature of the rotor holder (measuring chamber) and presents the “power on” display. Entering the date and time allows the operator to correct the time loss caused by the interruption. On completing the last ENTER two possible conditions can occur: i 1. The rotor holder temperature was in range during the checks, The video presents the principal menu. Note: The “Warning” indication may be given if the Peltier (reagent cup) or preheater temperatures are out of range at this instant. | Qe Instrumentation Laboratory - ; |1-20 General information 2. The rotor holder temperature was out of range. ‘The instrument display presents the alarm “INCUBATION TEMP QUT OF RANGE” in the upper section (A) of the video and the message "PLEASE WAIT" in the center section (B) of the video. ‘The "PLEASE WAIT" message, which also appears at first switch on of the instrument, is maintained for at least 15 minutes, to allow a correct warm up of the measuring chamber and the LED, after which the principal menu appears. Special Programs (Utility Menu) The instrument incorporates several special programs that allow certain functions of the instrument to be changed or set according to the individual needs. These programs also aid troubleshooting. Fault Detection The system automatically monitors faults to ensure accuracy of sample data and proper system performance. Fault monitoring includes display of alarms and warnings. 1.6 Procedural Limitations When "2" appears next to the title on the VDU, results-data should be interpreted with great caution. An evaluation of the cause should be determined before accepting the data. ‘The operating range for the ACL is between an ambient temperature of 15°-32°C (59°-89°F) at a relative humidity up to 85%. No safety hazards ccan occur in the temperature range 10°-40°C (50°-104°F) and functional performance characteristics are resumed when the instrument renters the range of 15°-32°C (59%-89°F). 4.7. Reverse Display Any particular situations concerning results and calibration parameters will be displayed in reverse. More specific details are given in section 3 (Operation) of this manual and in section 7 (Specifications). QQ) tostrumentauontaboratory‘ACL Operator's Manual 1-21 1.8 Bar Code Scanner The instrument is provided with a Bar Code Scanner which allows sample ID's reading ‘The bar code scanner can read numerical sample ID\s up to a maximum of 12 digits. The maximum bar code label lenght readable is 6 cm with a resolution of 0.2 mm. Numerical readable codes are: 1. Code 128 2. Code 39 3. Code 93 4. Codabar 5. Interleaved 2 of 5 6. MSV/Plessey The scanner is provided with a black on/off switch. When the scanner is, switched on it has a time out of 10 seconds. If no reading is performed in this period, the scanner will be switched off. Bar Code Scanner QQ) issirumentation aboratory2 Installation 2.0 Inspection This section sets out, in sequence, all the information necessary for the Correct installation and control of the instrument. ‘The instrument must be installed by IL personnel or other person(s) duly authorized by IL only. Note: Check carefully that, before starting installation, all the material identified in the shipping list is present. 2.1. Installation requirements 2.1.1. Ambient Conditions ‘The instrument will function correctly in an ambient temperature of + 15 to 32°C with relative humidity up to 85% (non condensing). The instrument should be placed in a position free from dust, fumes, vibrations and excessive variations of temperature. 2.1.2 Spatial Requirements ‘The maximum external dimensions are: - Height 45.cm 17,7 inches - Width 75cm 29.5 inches + Depth 63cm 24.8 inches + Weight 2Kg 114 lbs. During operation the heat generated by the instrument is expelled via the base and front of the instrument, For this reason, itis important that around the instrument and particularly on the left hand side, sufficient space is left to permit the circulation of air used for cooling. The instrument must be positioned so that a waste tube can be easily connected to the right hand side, Hf the operator wishes to work seated in front of the instrument, then empty space should be left under the front of the instrument. QS instrumentation Laboratory2-2 Instatation 2.1.3 Electrical Requirements The instrument has been designed to operate correctly with variations of up to + 15% on the nominal supply and with supply frequencies between 47 and 63 Hz. Note: Check that the nominal supply of voltage present in the laboratory is compatible with the label on the rear of the instrument as shown in the following table. Rear Panel Beacons nares 1 rszme Bereta wens 2 rene FF canripe tein 2 eanconesannen Value as shown onthe label Values of supply voltage for normal fun 220/240 V 220/230/240 Vac + 15% 115/125 V 110/115/120/127 Vac + 15% 100 V 100 V+ 10% Power Consumption Check that the supply connection is capable of supplying the 2.54 required at 220/240 V or 5.0 A at 115/125/100V. Note: The average power dissipation is about 300 W but peak loads or current surge when turning the instrument on can exceed this value. Qe tnctrumentation taboratory‘ACL Operator's Manual 2.2 Figura 2.1: Instrument Carrying Points 23 2-3 ‘Supply Frequency The instrument will function, without modification, at any frequency between 47 and 63 Hz. ‘The power cord is dedicated to the ACL analyzer; substitutions cannot be made. Instrument Unpacking Remove the box containing rotors and the shipping list. Extract the instrument and place it on the working surface. Note: Two people should Itt the instrument using the retractile handles ‘and the front canying points as shown in Fig. 2.1. Using the shipping list included check that all parts are present. In case of damage to the packaging, instrument or accessories notify the courier and your IL representative immediately. Instrument Parts Mounting Waste tube Connect the waste tube to the relative attachment on the bottom right hand side of the instrument. Cut the tube to a suitable length to fit into a waste container or drawwhich must be situated at a level below the instrument waste attachment. ‘Note: the orizontal section of the tube should be kept as short as possible and the free end should not enter the waste liquid. Reference Emulsion Bottle Place a bottle of reference emulsion in the appropriate position to the left of the dilutor fitting, and at the same time, insert the aspiration tube in it. Accesso + Fit the sample tray (fig. 2.3) on the relative support. Figure: 23: Sample Tray ~ Fit the reagent reservoirs in their appropriate positions as follows: MACRO PT/FIB (P/N 181021-51) in position 1 (Fig. 2.4) MACRO APTT (P/N 181021-52) in position 2 (Fig. 2.4) MACRO CaCl, (P/N 181021-53) in position 3 (Fig. 2.4) Instrumentation Laboratory‘ACL Operator's Manual Figure 2.4: Reagont Reservoirs 24 = ° 6 ———_——_ = Cay) : 30,, the frame goes into low light, the LED light ‘source is switched off and on the video is displayed the last ‘parameter, entered and confirmed. ~ Following the last data entry the video displays once again the ‘please wait” frame if the instrument is in the warm up period or the principal menu if the instrument is already warmed up. ~ Ifthe instrument is in the please wait phase the operator can enter the utilty program (PROG) in order to check or set-up the instrument Q) ostrumentauon taboratoryprior to starting analysis. it an analysis is carried out under these conditions the warning “INCUBATION TEMPERATURE OUT OF RANGE" is displayed and the print-out shows the relative error code. On exit from the analysis the ‘please wait” frame is once more displayed. Warning Before selecting and running any type of tests please check that: - Proper sample level is present in sample cups. Dead volume for 0.5 mi cups is 100 il and for 2 ml cups is 5001. - If primary tubes are used, make sure that the quantity of blood collected allows a filling volume within the specifications stated by the manufacturer. = Adequate reagent level. Dead volume for PT/FIB, APT, Procomplex, Hepatocomplex and CaCI,teagent cups is 2 mi; for TT, enzyme and chromogenic substrate is 0.5 ml. Sensors The fluidic sensors work during the incubation phase of each cycle. The sampling arm moves to samples and reagents to check the effective presence of all liquids. Warning Do not remove the sample tray or reagent reservoirs until the fluidic check has been completed or the cycle will be aborted. For flags and alarms regarding sensors please refer to section 6. Loadiist ‘Action If Sample ID has been selected in the Data Transmission Program (Section 4.10: Sample ID/Batch No. Selection) during the cycle the operator will be able to key in sample ID's or recall a loadlist already stored in PROG Loadlist. For additional information see Section 4.1. Before starting analysis the instrument displays the following frame. QS instrumentation aboratory