Triturus Analyzer Instructions for Use

Transcription

1 Triturus Analyzer Instructions for Use Triturus Analyzer Instructions for Use Diagnostic Grifols, S.A. Passeig Fluvial, Parets del Vallès, España (Spain) Tel. [34] Fax [34]

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3 TRITURUS ANALYZER Instructions for Use Diagnostic Grifols, S.A. Passeig Fluvial, Parets del Vallès, ESPAÑA (SPAIN)

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5 PLEASE READ THESE INSTRUCTIONS FOR USE CAREFULLY BEFORE STARTING TO WORK WITH THE EQUIPMENT Information about matters relating to the equipment safety can be found in Chapter 2 SAFETY INFORMATION. The symbols used in these Instructions for Use are as follows: DANGER! Any kind of injure critical or not for people, that only can be diminished following the instructions shown. WARNING! Any kind of injure for people for which other protection systems are provided, but it is convenient the RESPONSIBLE AUTHORITY or the OPERATOR knows it. CAUTION! Any kind of harmful situation for equipment or others. This situation can be diminished using this indication or with other protections. Used for clarification and complementary or emphasised information. Definitions: RESPONSIBLE AUTHORITY: Individual or group responsible for the use and maintenance of equipment, and for ensuring that operators are adequately trained. OPERATOR: Person operating equipment for its intended purpose. The operator should have received training appropriate for this purpose. QUALIFIED TECHNICIAN: Person responsible for the installation, reparation and special maintenance of the equipment who has received specific training for this purpose. All restrictions referred to RESPONSIBLE AUTHORITY are valid for the OPERATOR.

6 This instrument is protected by international patents that affect all the equipment and parts of it. The manufacturer reserves the right to legal action in order to protect his interests. In the same way, information contained in this document can be changed without any prior warning.

7 Table of contents TABLE OF CONTENTS Page 1 INTRODUCTION Indications of use Purpose, limitations and operator training SAFETY INFORMATION Important safety instructions Equipment labelling Read before using EQUIPMENT CHARACTERISTICS Technical specifications Triturus specifications Software characteristics Accessories Regulatory Description of the equipment parts INSTALLATION What to do on when it arrives Installation requirements Mains power supply connection Water connection Drain Computer equipment Connections diagram OPERATING PROCEDURE Putting into operation Worksheet REAGENT LAYOUT SHEET Multibatch operation STATUS SHEET RESULTS SHEET i

8 Table of contents 8.1 Test Information TEST PROGRAMMING Test Programming window Creating and editing tests Wash programming Common reagent programming REVISION OF THE EXECUTED BATCHES Results by batch Export results FITTING WITH A MEMORIZED CURVE Description Memorizing Fitting with a memorized curve Messages Results WELL VERIFICATION Description Programming the step Execution of step Results QUALITY CONTROL Analysis Quality Control Programming the Quality Protocol Obtaining reports Other options of the Quality Control menu MULTIPLE AND/OR SERIAL DILUTION OF SAMPLES Programming multiple or serial dilution Results SEROTHEQUE Description Programming ii

9 Table of contents 15.3 Processing Report Viewing reports Exporting results MISCELLANEOUS OPERATIONS Initialize Priming Rinse Decontamination Emptying of the waste container Manual probe washing Self-Test Technical Service Password control Configuration Help MAINTENANCE Maintenance plan Cleaning and decontaminating equipment Information about contaminant liquids Decontaminating liquids Computer system TRANSPORT AND STORAGE Equipment storage Unpacking the equipment Locating the equipment HOW TO DISPOSE OF THE INSTRUMENT WARRANTY WARNINGS AND INCIDENTS Messages in the System Warning window Incidents in batch verification iii

10 Table of contents 21.3 Incidents in the execution of a batch Other incidents TROUBLESHOOTING MAINTENANCE SERVICES iv

11 Introduction 1 INTRODUCTION THIS EQUIPMENT IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE (IVD). THE TRITURUS ANALYZER IS AN OPEN SYSTEM, DESIGNED FOR USE WITH GENERIC REAGENTS TO PERFORM ELISA TESTS AUTOMATICALLY, AND WHICH HAS NOT BEEN DESIGNED TO PERFORM ANY SPECIFIC ANALYSIS. THE USER IS RESPONSIBLE FOR THE INDIVIDUAL VALIDATION OF EACH TESTS WITH THE APPROPRIATE REAGENTS IN THE TRITURUS ANALYZER, BEFORE USING IT FOR THE PURPOSE OF PERFORMING ANALYSES. THE TRITURUS HAS NOT BEEN DESIGNED TO CREATE, MODIFY, SAVE, RECOVER OR MAINTAIN ANY ELECTRONIC FILES REQUIRED TO DEMONSTRATE COMPLIANCE WITH FDA REGULATIONS. CONSEQUENTLY, THE TRITURUS ELECTRONIC FILES MAY NOT BE USED TO REPLACE THE PAPER FILES SUBJECT TO SAID AGENCY S REGULATIONS. These Instructions for Use, which are intended for the OPERATORS of the Triturus, contain all the information that is necessary for safely and adequately working with the instrument. Please carefully read all this information before attempting to work with the equipment, especially on the maintenance section, the suggestions for correct use and the information about contaminating liquids. If you have any doubt whatsoever, please get in touch with the manufacturer or corresponding distributor before starting any operation. These Instructions for Use should be accessible to all the personnel who work with the instrument. 1.1 Indications of use The Triturus is an autoanalyzer of enzyme immunoassay on 96 well plates, open system and fully automatic, able to perform different assays to a group of samples and to process several batches simultaneously. 1-1

12 Introduction 1.2 Purpose, limitations and operator training The Triturus has been designed to automatically perform all the steps of an ELISA plate test. The equipment is capable of sequentially processing an indefinite number of plates with a maximum of eight tests in each one, using two sampling and dispensing probes with fixed and/or disposable tips. The samples that are employed must be human serum samples. The equipment has been designed to be used with enzyme immuno-reaction techniques reactive kits. Duly prepared personnel who have received training in the use of the Triturus should only use the equipment. The use of this instrument for purposes other than specified by the manufacturer or distributing company shall automatically invalidate any type of warranty. 1-2

13 Safety information 2 SAFETY INFORMATION 2.1 Important safety instructions DANGER! Misuse of the equipment can impair the protection provided by itself. DANGER! This equipment works with some substances that carry a chemical or biological risk. The established regulations for working in laboratories in relation to the use of suitable gloves or other personal protective means should be followed. DANGER! In the event of any spillage into the equipment, it must be isolated from the electrical supply, cleaned up and decontaminated. In any case the instrument must be disassembled and the equipment must not be reconnected until it has been fully inspected by a QUALIFIED TECHNICIAN. WARNING! This equipment only must be used by RESPONSIBLE AUTHORITY, OPERATORS and QUALIFIED TECHNICIANS. WARNING! Basic safety precautions must always be taken, including those indicated in section 2.3 Read before using. Furthermore, before installing the instrument, the rules of 4.2 Installation requirements section must be read. 2-1

14 Safety information CAUTION! Using cables other than those specified may result in increased electromagnetic emissions and/or decreased immunity of the equipment. CAUTION! The equipment should not be used adjacent to or stacked with other equipment, and if adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it will be used. WARNING! Electromagnetic compatibility and electrical safety tests have been performed using the cord supplied by the manufacturer. However, if it is necessary to use another cord, be sure that the new cord meets the following specifications: Cable type: Flexible cable with insulation and PVC cover with 3 conductors (neutral, live and earth). Cord length: 2m. Conductor section: 1mm 2 or higher. Connector type: For IEC inlet. Connector for class I appliances. Plug type: Plug type used in the country where the equipment is installed and with earth connection. Connector, cable and plug must comply electrical safety requirements applicable in your country. 2-2

15 Safety information 2.2 Equipment labelling The equipment is marked with the following labels: Figure 1: Equipment labelling (1) Laser product. (2) Wipe all spills dry. (3) Moving part. (4) Biohazard and risk of injury from the probes (5) Biohazard and risk of injury from the wash manifold. 2-3

16 Safety information (6) Hot surface. (7) Identification of containers and waste tray. (8) Waste tray biohazard. (9) Waste container biohazard. (10) Waste container cap biohazard. (11) Equipment specification. (12) Container connection diagram. (13) Correct placement of the reagent tray. (14) Mains supply connection. (15) Computer connection. (16) Waste disposal connector. (17) Instrument front. (1) Laser product label. This is located on the laser bar code reader and contains the information that is required by the EN standard: Laser products safety. Part 1: Equipment classification, safety requirements and guide. It includes the laser product classification, the symbol and safety message text. (2) Wipe all spills dry label. It is located above the plate-loading platform and points out the importance of keeping it clean from any liquid spills in order to avoid damaging the equipment. 2-4

17 Safety information (3) Moving part label. This label is located on the equipment moving arm and warns of the movement of this part. As a safety precaution, in order for the arm to move, the doors covering the inside of the instrument must be closed or the door covering the carrousel must be totally open and the main door closed (so that the zone of arm movement is separated from the OPERATOR). (4) and (5) Biohazard and risk of injury from the probes and from the wash manifold labels. This label (4) can be found on the front part of the moving arm near the lower zone, where the dispensing probes are located. These probes suppose a biohazard since they are in contact with the samples and reagents etc, and also due to the risk of injury from the cutting edge at the end. This label (5) is located on the wash capillary manifold. This point also comes in contact with biological liquids (it washes the well contents) and there is a danger of injury from the needles that form the manifold where the wash solutions are dispensed. 2-5

18 Safety information (6) Hot surface label. This is fitted to the incubator, and warns of the possibility of the surface being at a high temperature. The maximum temperature for normal operation is 50 ºC. (7) Identification of containers and waste tray labels. These labels can be found on the front of the containers and the waste tray and are visible when the lower door is open. Their function is to identify each container so that it can be correctly positioned and also to identify their contents. In addition, the waste tray for the used disposable tips is also identified. 2-6

19 Safety information 2-7

20 Safety information (8) Waste tray biohazard label. This is fitted to the front of the disposable tip waste tray and indicates the biohazard supposed by these tips that have been in contact with biological liquids. There is an additional risk due to the presence of aggressive chemical substances. (9) Waste container biohazard label. It is located on the front of the waste container, which is where the waste produced during the tests is collected, and warns that its contents is a biohazard. (10) Waste container cap biohazard label. It is located on the cap of the waste container and warns that it is a biohazard and that it contains aggressive chemical substances. The cap should not be used with the other containers and it is distinguished by its red colour. 2-8

21 Safety information (11) Equipment specification label. The following information is provided by this label: Supply voltage, frequency, power, fuses, model, serial number, manufacturing date, manufacturer s name and address. The following symbol is used: : manufacturing date (12) Container connection diagram. This is fitted to the inside of the folding door that provides access to the containers and waste tray. This label consist of a diagram showing the correct connection and placement of the containers, together with explanatory warning text in order to prevent injury to personnel and damage to the equipment. 2-9

22 Safety information (13) Label of correct placement of the reagent tray (Ref. 13, Figure 1). This indicates the correct position for placing the reagent tray. It is fixed on the base where this tray should be placed. (14) Mains supply connection label. It indicates the connector for the mains supply cable. (15) Computer connection label. It indicates the connector for the computer cable. 2-10

23 Safety information (16) Waste disposal connector label. This label indicates the connection for the optional automatic disposal of the waste container. (17) Instrument front label (Ref. 4, Figure 2). Contains: - A green power-on pilot lamp (upper left). - A pushbutton to request the opening of the door to the sampling and carrousel area (lower left). - A pushbutton to request the opening of the reagent drawer (lower right). - An orange pilot lamp that when on indicates that the instrument main door should not be opened (upper right). 2-11

24 Safety information 2.3 Read before using - Use the equipment only for the purpose described in the Instructions for Use. - Unless specifically instructed to do so by the Instructions for Use, do not drop or put anything into any opening in the equipment. - Do not use the equipment if it is not working properly, or if it has suffered any damage. Examples of defects typically include: 1) Visible damage caused by dropping the equipment. 2) Visible damage caused by liquid spillage. 3) Visible damage caused by subjection to prolonged storage and under unfavourable conditions or by subjection to severe transport stresses. 4) Damage to the flexible supplies cord or its plug. - Do not use the equipment in hazardous atmosphere, or with hazardous materials for which the equipment has not been designed. - Do not use any accessories which are not supplied or recommended by the manufacturer. - For refilling the containers you must before take them away from the equipment. - Keep air openings free from lint, hair, dust, etc. - Main fuses only must be replaced by a QUALIFIED TECHNICIAN. - This instrument should only be disassembled by a QUALIFIED TECHNICIAN, either for internal cleaning and/or for repairing. Before disassembling, the equipment must be unplugged. - Before using any cleaning or decontaminating method of section 17.2 Cleaning and decontaminating equipment, the equipment must be unplugged. - Switch off the equipment after using. 2-12

25 Equipment characteristics 3 EQUIPMENT CHARACTERISTICS 3.1 Technical specifications MODEL: SUPPLY: PROTECTION AGAINST ELECTRIC SHOCK: TRITURUS Voltage: / V~ Frequency: Hz Input power: 300 W Fuses: 2 x T4AL 250V, 5x20 mm. Class: I INSTALLATION CATEGORY: DIMENSIONS (cm): WEIGHT (Kg): MATERIALS: TRANSPORT AND STORAGE CONDITIONS: BOTTLE WORKING PRESSURE: COMPUTER EQUIPMENT REQUIREMENTS (not supplied with the Triturus ) Overvoltage category II (local level, appliances, portable equipment, etc.). 72 depth x 105 width x 87 height. Approximately 120 kg. Packaging: wood, polyurethane. Electronic and electric components: motors, circuits, cables. Equipment: polyurethane (expanded foam), aluminium, stainless steel, glass... Temperature: Maximum relative humidity non condensing: -10ºC to 60ºC. 85%. Approx. 230 mbar (pressure). < 500 mbar (vacuum). Controlled by PC with 128 Mb of RAM or higher, with LPT1 parallel port and at least one free standard serial RS-232C port. Operating system Windows 2000/XP. Compatible printer. 3-1

26 Equipment characteristics OPERATING CONDITIONS: Indoor use Temperature: Maximum relative humidity non condensing: Minimum relative humidity non condensing: Maximum altitude: Mains supply maximum voltage fluctuations: 10ºC to 40ºC (less than 25ºC for the correct performance of the temperature control during incubation). 80% for temperatures up to 31ºC, decreasing linearly to 50% at 40ºC. 30%. 2000m. 10% of nominal voltage. The Triturus has been designed and tested so that it complies with all the necessary requirements of accuracy and reproducibility in the handling of liquids, contamination, temperature stability and accuracy, precise mechanical movements and all those parameters that might affect the specific tests for which it has been designed. Any other specifications are not guaranteed, especially in the case where the equipment is used for functions other than the ones for which it has been designed. 3.2 Triturus specifications Samples: 92 Predilution tubes: 96 Simultaneous tests: 8 Controls / test: Up to 14 controls. Calibrators / test: Up to 14 calibrators. Diluent / test: 1 Disposable sampling tips: 120 Simultaneous plates: 4 3-2

27 Equipment characteristics Sample bar code detection, with automatic orientation: Detection of the presence of samples, predilution tubes, disposable tips, calibrators and controls vials, diluent vials and plate wells: Loading of new work batch while processing the previous one: Yes (Bar Code Types: Code 39, Industrial 2 of 5, Codebar, Code 128) Yes Yes Common reagents: 12 Disposable tips for common reagents: 32 Reagent drawer with removable tray: Plate incubators: Yes 4 independent. Incubation temperature: Independently selectable from 25 to 40 ºC for each incubator. Incubation shaking: Selectable, jointly for the 4 incubators. Incubation time: Plate washer: Wash solutions: Wash type: Wash manifold: Normal wash volume: Continuous wash time: Soak time: Maximum number of wash cycles: 6 Read channels: 1 Read type: Wavelengths: Programmable. 8 suction channels, 8 for dispensing. 2 selectable and H 2 O for cleaning. Programmable in cycles, volume and time, continuous wash option. Removable and can be placed in an autoclave. 50 to 350 µl. 0 to 3,1 seconds. 0 to 127 seconds. Monochromatic or dichromatic. 405, 450, 492, 550, 600 and 3-3

28 Equipment characteristics Filters: Dynamic range: 620 nm. Up to 7 interferential filters. Up to 3 O.D. Linearity: 1% at 405 nm between 0 and 2 O.D. Liquid Containers: 5: Wash 1, Wash 2, Prime, H 2 O, Waste. Capacity: Container control: Pressure control: Capacity of the disposal tray: Arm: Level sensors: Obstruction detectors (clot): Sample tips: Reagent dispensing tips: Fixed needle wash: 4 litres (each). Minimum and maximum volume control by weight on load cells. 1 pressure sensor and 1 for vacuum. Up to 1000 tips. 2 probes and 1 plate transport grip. 2, one in each probe. 2, one in each probe. Fixed or disposable tips. Fixed or disposable tips. Double wash station. Drift contamination: For disposable tips: 0% For fixed needle: it depends on the programmed wash. Dilution capacity: Up to 1:500. Dilution precision (fixed needle): 5%. Dilution precision (disposable tip): 5%. 3.3 Software characteristics - Familiar User Interface is based on the Windows operating system. - Simple programming of tests and reagents. - It allows the tests to be easily grouped together in profiles and folders. 3-4

29 Equipment characteristics - Intuitive programming of new batches. - Connection to a central computer. - Real time graphic information on the status of each plate under execution. - Results processing based on the following calculation methods: - Cut-Off. - Single point. - Point-to-point. - Linear regression. - Polynomial regression. - Cubic spline. - 4PL. - Lin-Log. - Log-Log. - Logit-Log. - Results print by tests and by samples. - Import of tests. 3.4 Accessories CODE DESCRIPTION PRESENTATION Carrousel Triturus Multi-format Carrousel Red adapter ring White adapter ring ml microtube adapter, with bar code ml microtube adapter Tube centering rings Calibrator and control vials, 2ml Caps for calibrator and control vials Reagent containers Reagent container caps

30 Equipment characteristics CODE DESCRIPTION PRESENTATION Disposable sample tips Disposable reagent tips Plate frames/covers. 8 / Plastic protector reagent tray Waste container Container: Distilled water / Wash solution A and B / Priming solution Disposal tray Reagent tray Serotheque adapter Waste water hose Performance check kit Regulatory Triturus, conforms to the requirements of the Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices. 3-6

31 Equipment characteristics 3.6 Description of the equipment parts Figure 2: Identification of the external parts of the equipment (1) Carrousel and sampling station access door. (2) General door. (3) Reagent drawer. (4) Interlock pushbuttons on the access door to the carrousel and reagent drawer and ON indication. (5) Containers and waste container access cover. (6) Main switch and mains supply connection. (7) Computer (PC) cable connector. (8) Connection for automatic waste container disposal. 3-7

32 Equipment characteristics Figure 3: Identification of the internal equipment parts (1) Sample carrousel. (2) Tube rotator. (3) Bar code reader. (4) Plate-loading platform. (5) Diluters. (6) Reagent tray. (7) Probe wash station. (8) Plate incubators. (9) Plate washer. (10) Plate reader. (11) Movable arm. (12) Cover station. (13) Processed plates deposit. (14) Containers. (15) Waste tray. (16) Reader light source (lamp and filter wheel). 3-8

33 Equipment characteristics Sampling station Sample carrousel Figure 4: Carrousel This is a circular support that is divided into two concentric crowns. The exterior crown contains positions for 188 tubes: 92 for samples (Ref. 1, Figure 4) and 96 for sample dilution, controls and calibrators (Ref. 2, Figure 4). If 4 consecutive empty positions are left on the sample crown, the tubes placed after them will be considered predilution tubes. These tubes will be used in the event that more than 96 predilution tubes should be necessary. It also contains another 120 positions for disposable tips (Ref. 3, Figure 4), which are used for calibrator, control and sample dilution according to the test programming. The interior crown is divided into eight colour-coded sections, each having a space for one 50-ml diluent container (Ref. 4, Figure 4) and 7 positions for calibrators and controls (Ref. 5, Figure 4). The carrousel is totally removable and interchangeable in order to facilitate its loading and unloading by the OPERATOR. 3-9

34 Equipment characteristics Tube rotator A system that is employed to rotate the sample tubes in order to correctly orientate them so the bar code reader may read them Bar code reader This is used to read the bar codes on the sample tubes in order to identify them. The following should be taken into account for optimum operation of the automatic bar code reader: - The labels should be firmly fixed to the sample tubes and the bar codes should be horizontally lined-up, clean and sharp. - The lower edge of the code should be more than 15 mm from the tube base and the upper edge should be less than 55 mm from the tube base Plate-loading platform This has the capacity for four superposed plates (Ref. 1, Figure 5). From this position the plates are moved on to the incubator by the movable arm and will be replaced just before beginning the dilutions and dispensation of calibrators, controls and samples. Each plate must have a plate carrier frame, which is a plastic frame that fits around the plate and has two slots to gripe it by the movable arm. The automatic detection of well strips also takes place on this platform. The platform can be folded in order to remove the sample carrousel (Ref. 2, Figure 5). Raise the latch (Ref. 1, Figure 6) to return the platform to its original position. CAUTION! Do not fold the platform with a plate inside. If plates contain liquids, these liquids could be spilled inside the equipment. 3-10

35 Equipment characteristics Figure 5: Plate-loading platform lowered Figure 6: Plate-loading platform raised 3-11

36 Equipment characteristics Reagent tray Figure 7: Reagent tray The reagent drawer (Ref. 2, Figure 7) is fitted with a twelve-position tray for 50-ml plastic containers for various reagents (Ref. 1, Figure 7) and 32 positions for 1100 l disposable tips for pipetting (Ref. 4, Figure 7). The reagent tray may be removed from the equipment and stored in a refrigerator (Ref. 3, Figure 7). CAUTION! Avoid any rapid movement of the reagent drawer in order to prevent reagent spills Incubators Heated surface divided into 4 different areas where plates can be incubated. The temperature in each area may be separately programmed from room temperature to 40 ºC. It also includes the possibility of orbital agitation of the plate set. 3-12

37 Equipment characteristics Washer It includes a plate carrier and a wash manifold, which dispenses the wash solution and also sucks up the waste. The carrier is fitted with a bath for automatically washing the manifold and a draining system that will collect any remaining solution that could spill during the wash operation Fluid system There are five 4-litre containers, located in the lower part of the instrument. Two of them contain wash solutions for plates, another for the final fluid system rinse (distilled water for normal laboratory use), another holds the probe wash solution (saline solution for normal laboratory use, NaCl 0,9%) and the last one is for the waste. The system automatically monitors the remaining liquid volume in each container and it also has an optional system for automatic waste disposal. In addition, the fluid system is fitted with a probe wash station that consists of two cylindrical containers for submerging the probes to wash them with a suitable solution after they have been in contact with the samples or reagents Reader This consists of a halogen lamp, interferential filters of various wavelengths (see 3.2 Triturus specifications ), and a specific plate light meter for monochromatic and dichromatic readings with a dynamic range of up to 3 O.D Diluters It consists of four syringe modules. Each probe has two associated modules: one with a 500 µl syringe for greater precision dilution (calibrators, controls and samples) and the other with a 2500 l syringe for pipetting of reagents Movable arm This mechanism is used to transport the plates and incorporates the suction/dispensing probes. It is capable of performing up to five different linear movements: - X: Transverse arm movement. - Y: In/out arm movement. - Z1 and Z2: Vertical movement of each suction/dispensing probe. 3-13

38 Equipment characteristics - Hook: Vertical movement of the plate frame gripping system. The mechanism includes a clot (or blockage) detector and a liquid level sensor for each probe. CAUTION! There is a zone at the end of each probe that is sensitive to liquid contact for automatic level detection. The probes should be both clean and dry for correct operation. Under normal circumstances, they are automatically maintained in these conditions, however, when necessary, the OPERATOR should intervene to clean and/or dry them. WARNING! The movable arm is the element that implies most danger. Although measures have been taken to minimise the risks, all safety measures that are given in the Instructions for Use and marked on the labels should be strictly observed Cover station and processed plates deposit Figure 8: Cover station and processed plates deposit The cover station will normally hold four plate covers (Ref. 1, Figure 8). The instrument will automatically use them to cover the plates in order to prevent any evaporation of the liquids during the incubation processes. 3-14

39 Equipment characteristics The used plate container holds the plates for which the processing has finished (Ref. 2, Figure 8). They shall be removed manually for disposal after the prior recovery of the plate carrier frame. CAUTION! The reagents used can be corrosive. In order to avoid the deterioration of the instrument, remove the vials as well as the plates from the processed plates deposit when the batch is finished Computer accessories In addition to the instrument equipment, the operation of the Triturus system requires the following computer accessories: - The Triturus software: It is supplied with the equipment. This program is responsible for the controlling of the equipment functions and the later processing of the obtained data. This program runs under the Windows operating system. - PC: See section 3.1 Technical specifications (not supplied with the Triturus ). - Printer: See section 3.1 Technical specifications (not supplied with the Triturus ) Other required elements Independently of the units supplied with the instrument, the indicated materials may be obtained through your habitual distributor. Consult the table in section 3.4 Accessories Sample and predilution tubes Tubes of 12x75 or 13x75 mm should be employed, both for the samples as well as for predilution. They are not supplied with the Triturus. 3-15

40 Equipment characteristics (a) (b) (c) Figure 9: Sample tube: (a) 12-13x75 mm tubes; (b) 2 ml microtubes; (c) 1.5 ml microtubes 1.5 and 2 ml microtubes such as those shown in Figure 9 (a) and (b) may also be used in carrousel sample positions. To do so, any available adapters must be used ( / ). This kind of microtubes allows three working modes: - The instrument uses microtubes for every sample and in every batch. - The instrument allows batches to be alternated between 12-13x75 mm tubes and microtubes. User must choose between 12-13x75 mm tubes or microtubes in sample positions. Microtubes and 12-13x75 mm tubes may not be used in the same batch. - The instrument allows 12-13x75 mm tubes and microtubes to be alternated. To add this function, contact your distributor. To use tubes or microtubes with formats other than those described above, the Triturus analyzer uses the TRITURUS Multi-format Carrousel. Contact your distributor for installation. CAUTION! Using, in the carrousel samples positions, 12-13x75 mm tubes and microtubes within the same batch can cause deterioration and malfunction of the instrument if not configured correctly. Contact your distributor to confirm the configuration. To configure the Triturus in order to be able to alternate 12-13x75 mm tubes and microtubes batches in carrousel sample positions, please contact a QUALIFIED TECHNICIAN. 3-16

41 Equipment characteristics The minimum sample volume for correct level detection is 300 µl. CAUTION! Any presence of foam, bubbles or drops on the tube side could cause sample-dispensing failure, with a corresponding error in the test results. CAUTION! The use of tubes other than those specified could cause instrument damage Tube centering rings The tube centering rings shown in Figure 10 are placed in the carrousel when the outside diameter of the sample or predilution tubes is 12 mm. Figure 10: Tube centering rings Disposable tips The probes can use both disposable tips or directly use the fixed needle fitted the actual probes themselves. The 300 µl tips are fitted to the carrousel and are used for sampling. The 1100 µl tips are fitted to the reagent tray and are used for reagent dispensing. 3-17

42 Equipment characteristics Figure 11: Disposable tips CAUTION! The use of disposable tips other than those specified could cause damage and incorrect operation of the instrument Diluent and reagent containers These are located on the carrousel for sample diluent and in the reagent tray for reagents. Figure 12: Reagent container 3-18

43 Equipment characteristics CAUTION! The minimum reagent volume for correct level detection is 1 ml. CAUTION! The use of containers other than those specified could cause instrument damage Control and calibrator vials These are used to contain the controls and calibrators on the carrousel. CAUTION! The minimum control/calibrator volume for correct level detection is 125 µl. CAUTION! The use of control or calibrator tubes other than those specified could cause instrument damage. Figure 13: Controls and calibrators vial 3-19

44 Equipment characteristics CAUTION! Any presence of foam, bubbles or drops on the vial side could cause controldispensing or calibrator-dispensing failure, with a corresponding error in the test results Plate frames and covers The plates (Ref. 2, Figure 14) should be fitted inside the plate carrier frame supplied with the instrument (Ref. 3, Figure 14). They transport within the instrument inside this frame and are automatically covered with a plate cover during incubation processes (Ref. 1, Figure 14). The prepared frames must be entered in the instrument through the plateloading platform (Figure 5), and removed, once the processing has finished, from the processed plates deposit (Ref. 2, Figure 8). The plate covers (4 units) are held in the cover station (Ref. 1, Figure 8), from which they are taken when required and to which they are returned after use. The frames and the covers have a chamfer that facilitates their correct positioning. They are also fitted with two pivots, one larger than the other, on the upper surface, and two corresponding holes on the lower surface for exact positioning in the instrument. There are also two slots for gripping them during transport. Figure 14: Plate frame and cover 3-20

45 Equipment characteristics CAUTION! If any deformation is noted in the slots, the pivots or the general appearance (bended sides or warping) of a frame or cover, then it should be discarded and substituted by a new one so it could cause important damage to the instrument. CAUTION! The use of frames and covers other than those specified could cause damage to the equipment. 3-21

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47 Installation 4 INSTALLATION 4.1 What to do on when it arrives QUALIFIED TECHNICIANS should always install this equipment. The QUALIFIED TECHNICIAN will provide all the necessary information that is required by the OPERATOR in order to put it into operation. On receiving the equipment, it should be checked to ensure that it includes all those elements specified on the Packing List that is inside the package. To unpacking the equipment, section 18.2 indications must be followed. 4.2 Installation requirements The requirements for the site where the equipment is to be installed are as follows: - Environmental conditions: See section 3.1 Technical specifications. - Space requirements: It is recommended that a solid and flat surface is available that is capable of supporting more than 120 Kg in weight and which has dimensions of at least 125 x 90 cm. - Do not place the equipment out-of-doors. - Do not place the equipment on a surface of flammable material. - Do not place the equipment so that it is difficult to access for maintenance or technical service - Do not block air openings. - Do not place the equipment where it could get wet. - Do not position the equipment so that it is difficult to operate the mains supply switch. - Do not let the equipment or its flexible cord come into contact with surfaces, which are too hot to touch. - Do not place any objects on top of the equipment. CAUTION! Exposure to intense light levels should be avoided as this could affect the operation of the equipment. The position of the equipment can be adjusted by means of its feet. 4-1

48 Installation 4.3 Mains power supply connection Mains power supply connections are required for the Triturus, computer and printer. Consult the requirements in the equipment specification label (Ref. 11, Figure 1). 4.4 Water connection A water connection is not required. All the solutions used by the Triturus are stored in removable 4-litre containers inside the equipment. 4.5 Drain All the produced waste is taken to a removable 4-litre container. However, there is the possibility of automatic liquid waste disposal from the equipment (Ref. 8, Figure 2) directly to a drain that has been authorised for this type of waste. 4.6 Computer equipment The computer equipment, with the Windows operating system, should be installed in accordance with the supplier s standard procedures. The Triturus program should be installed by a QUALIFIED TECHNICIAN trained by the manufacturer. 4.7 Connections diagram Figure 15: Connections 4-2

49 Installation ID FUNCTION 1 Triturus mains supply cable. 2 Computer mains supply cable. 3 Printer mains supply cable. 4 Connecting cable from Triturus to the computer. 5 Monitor cable. 6 Monitor mains supply cable. 7 Printer connection cable. 8 Keyboard connection cable. 9 Mouse connection cable. 4-3

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51 Operating procedure 5 OPERATING PROCEDURE CAUTION! To avoid possible software malfunction, it is recommended: - Not installing any additional software and/or hardware as far as the strictly required. - Disabling any screensaver and the Windows energy saving mode. The information contained in these Instructions for Use refers to an analyzer with the standard configuration using version 4.0 of the Triturus program. If yours is an earlier version of the program, there may be slight differences. For non-standard configurations of the analyzer, please consult the supplemental documentation or your distributor with any questions. Products that appear in these Instructions for Use screens have been included as an example. 5.1 Putting into operation In order to put the system into operation, connect the Triturus, the computer and the printer to the mains power supply in accordance with section 4.7 Connections diagram. Switch the Triturus on (Ref. 6, Figure 2). Then switch on the computer and the printer and wait for the operating system to correctly start up. The program is loaded by selecting the Triturus icon. The program will then initialize the equipment and display the Status Window with the following information: 5-1

52 Operating procedure Figure 16: Status Window (1) Worksheet: For the introduction of a new work batch. (2) Programming of test and profiles. (3) Results: For displaying the results of previous batches. (4) Quality Control: To access the Quality Control reports (see chapter 13 QUALITY CONTROL). (5) Stop button. (6) Menu bar with the following options: Run: It provides access to the Worksheet for the processing of a batch (equivalent to selecting Ref. 1, Figure 16). Programming: It allows new tests to be programmed (equivalent to selecting Ref. 2, Figure 16). A password is required if password control is selected (see 16.9 Password control ). Results: It allows the results of previous batches to be displayed (equivalent to selecting Ref. 3, Figure 16), and it allows the results of previous batches to be exported. Quality Control: It allows you to access to the Quality Control menu in order to program Protocols and make Reports (see chapter 13 QUALITY CONTROL). 5-2

53 Operating procedure Misc.: It allows getting access to Initialize, Priming, Rinse, Decontamination, Emptying of the Waste Container, Manual Probe Washing, Self-Test, Technical Service, Passwords and Configuration (see Chapter 16 MISCELLANEOUS OPERATIONS). Help: It provides information about the Triturus Program. (7) System Warning window. (8) Program version identification. 5.2 Worksheet The Worksheet displays the tests and samples to be processed in one batch. Selecting the Worksheet icon (Ref. 1, Figure 16) will cause the Worksheet to appear with an overlaid dialogue box that enables the OPERATOR to decide the type of sample identification to be used. Figure 17: Worksheet (1) Automatic sample identification. (2) Manual sample identification. (3) Host (only enabled when a Host connection is configured). (4) Repeat carrousel. 5-3

54 Operating procedure In addition to the identification options, a button appears (Ref. 5, Figure 17) which allows the dialog box to be closed. At this point, the OPERATOR will have access to the carrousel and to the reagent drawer. DANGER! Be sure that the introduced samples are free of fibrin and clots Automatic identification of samples This option permits the reading of the bar codes that identify the sample tubes in the carrousel. Place the bar-code-identified samples in the outer carrousel crown (Ref. 1, Figure 4). Close the carrousel access door (Ref. 1, Figure 2). Select the Automatic option (Ref. 1, Figure 17). The equipment will then read the bar codes and display the identification of samples on the Worksheet. An ERROR message will appear in the corresponding sample position in a situation where the reader is unable to identify one or more detected samples. If the OPERATOR so desires, the samples that have not been read automatically may now be identified manually. Selecting each nonidentified sample and pressing the Sample Loading icon, followed by the introduction of the corresponding code does it. The Worksheet should be completed by entering the tests to be performed on the identified samples (see section Completing the Worksheet ). CAUTION! It is important for correct equipment operation that the bar code labels are correctly fixed to the sample tubes and that their position and the orientation of the bars is the indicated in the Figure

55 Operating procedure >4 mm <28 mm <50 mm >15 mm Figure 18: Label position on the 12-13x75 mm tube and the microtubes Manual identification of samples This option allows the number of samples and their identification to be entered via the keyboard. Place the samples in the outer carrousel crown (Ref. 1, Figure 4). Close the carrousel access door (Ref. 1, Figure 2). Select the Manual option (Ref. 2, Figure 17). A dialogue box appears where the number of samples to be analysed and their identification should be entered. Figure 19: Sample loading 5-5

56 Operating procedure An Auto-enumeration of the samples that have been entered can be performed manually. For it, the identification number of the first sample is entered with a sufficient number of digits to carry out a correlative numbering of the rest of the samples and select the Auto-enumeration option. Click on OK to continue. Complete the Worksheet by entering the tests to be performed on the identified samples (see section Completing the Worksheet ). For greater ease when inserting the tubes and microtubes, the carrousel may be removed from the instrument. In order to do this, raise the plate-loading platform (Ref. 4, Figure 3) and then lift the carrousel straight up until it is free of its support shaft. To introduce the carrousel again, maintain the plate-loading platform in the raised position and return the carrousel to its initial position. DANGER! The sample identification safety is reduced if samples are identified manually. The OPERATOR must be sure that the samples are correctly identified and positioned in the correct place. CAUTION! Ensure that the carrousel is correctly positioned in the equipment. The carrousel support shaft is fitted with a pivot that must be located in the corresponding hole on the carrousel when the latter is correctly fixed in position Repeat carrousel This operation allows the repetition set of samples that were analysed in the previous batch. Fit the carrousel. Close the carrousel access door. Click on the Repeat button (Ref. 4, Figure 17). The samples will automatically be displayed on the Worksheet. 5-6

57 Operating procedure Complete the Worksheet by entering the tests to be performed on the identified samples (see section Completing the Worksheet ). CAUTION! This option provides very little security in sample identification. They should not be handled in order to prevent any possible errors. If during the identification process, samples with the same identification number are entered, a message will appear indicating this situation Completing the Worksheet Once the sample identification has been carried out, the batch to be performed by the Triturus should be completed in the Worksheet (Figure 20). The Worksheet is divided into two clearly separate areas: - Tests and Profiles Menu (Ref. 1, Figure 20): A list of all the available tests and profiles. - Worksheet: This space is reserved for the entry of the tests to be performed on a new batch, together with the samples (Ref. 2, Figure 20) to be processed by this batch. Displayed on this screen can be found counters for the plates, predilution tubes, disposable tips and wells that are necessary for completing a given batch (Ref. 3, Figure 20). The Worksheet should be completed in the following fashion: Use the mouse to drag each of the tests to be performed, from the Tests and Profiles Menu (Ref. 1, Figure 20) to the space reserved for them on the Worksheet. 5-7

58 Operating procedure Figure 20: Creating a batch in a Worksheet Tests can be entered on the Worksheet by double-clicking on the name of each one on the Tests and Profiles menu. All the programmed tests and profiles on the menu may be displayed using the vertical scroll bar. Right-clicking with the mouse on the name of a test or profile will display a drop-down menu with the following options: Add: This allows a new test to be added to the batch. Cancel: It closes the menu. Each time that a test is dragged to the Worksheet, a dialogue box will open with the following options: - Cn: It permits the concentration value for each calibrator to be entered (Ref. 1, Figure 21). In the event that the Allow for calibrators and/or controls repetition at the end of test option is activated for the test, the program will display some selection boxes which allow selection of the calibrators to be repeated at the end of the test, once all of the samples are dispensed. 5-8

59 Operating procedure - COn: It allows the acceptance range of the controls to be entered. The maximum and minimum values that the controls can reach according to the specifications of the kit manufacturer can be entered (Ref. 3, Figure 21). If the Allow for calibrators and/or controls repetition at the end of test option is activated for the test, (see section Validation conditions data ), the program will display some selection boxes which will allow selection of the controls to be repeated at the end of the test, once all of the samples are dispensed. - Validation Conditions: It allows new validation criteria to be added in addition to those programmed in the test. - Traceability: It allows information to be saved about the user identification, the lot, and the expiry date of the kit being processed. Enter the numerical values corresponding to the test lot. Select whether the maximum and minimum values are expressed in concentration or optical density (Ref. 2, Figure 21). If there are more than 2 controls, they can be accessed by clicking on the scroll buttons. Figure 21: Calibrators and controls Click on OK to close the calibrators and controls dialogue box. 5-9

60 Operating procedure The dialogue box of the Calibrator and Controls can be opened again by double-clicking with the mouse on the test name on the Worksheet. The information of this dialogue box also can be introduced at the end of the execution of a batch. Right-clicking with the mouse on each one of the entered tests on the Worksheet will display a menu with the following options: Calibrators and Controls: It allows the calibrator s concentration value and the controls upper and lower limits to be modified. Select all Samples: It permits the test to be performed on all the samples entered on the Worksheet. Validation Conditions: It allows getting access to the window that corresponds to validation criteria entry. Delete: It allows a test to be removed from the Worksheet. Cancel: It closes the menu. Enter the samples if this has not already been done by means of the procedures described in section Automatic identification of samples. Select the Samples Loading icon (Ref. 4, Figure 20). A dialogue box with the following options appears (Figure 19): - Number of samples: It permits the entry of the total number of samples to be analysed. - Sample identification: It allows the position number of the sample on the carrousel to be entered and then the identification number. - Auto-enumeration: It allows selection of the option for autoenumerating samples entered manually. - Automatic: It allows automatic reading of the bar codes on the sample tubes in the carrousel. Select the previous or following samples to the one displayed by pressing Enter or by means of the scroll arrows (Ref. 1, Figure 19). Enter the corresponding identification code via the keyboard. Press OK to continue once the sample identification has been completed. 5-10

61 Operating procedure Once the Worksheet window options have been completed, the samples that are going to be analysed for each test should be selected. Click on the intersection of the test rows and sample columns that are to be selected. The samples may be selected by dragging the mouse over the corresponding boxes. Right-clicking with the mouse on a selected sample box will display a menu with the following options: Unselect: This allows the request for a specific test to be deleted, for a given sample. Replicates: It permits the number of replicates to be entered. A maximum of eight replicates per sample is accepted. Multiple Dilution: It allows different sample dilutions to be programmed (various dilutions starting with the sample or serial dilution of a sample). See chapter 14 MULTIPLE AND/OR SERIAL DILUTION OF SAMPLES. External Control: It allows you to identify a specific sample position on the carrousel as an external control (see chapter 13 QUALITY CONTROL). Print: It prints the Worksheet. Cancel: It closes the menu. Right-clicking on sample identification on the Worksheet, a menu will open with the following options: Modify Id: It enables a sample identification to be modified. Delete: It eliminates a programmed sample. Cancel: It closes the menu. Double-clicking on a sample number allows the identification to be modified. A deleted sample can be re-entered. To do so, right-click with the mouse on the sample number and click on Select. As new requests are entered, the Worksheet will display: 5-11

62 Operating procedure - The number of wells that are required in order to perform the test, taking into account the requirement or not for using blanks, calibrators and controls. - The number of predilution tubes and disposable tips that are required in order to perform the tests. - The number of plates to use and the well distribution on these plates. A batch may consist of one, two, three or four plates and a maximum of eight different tests. The number of plates used will depend on the tests selected and the number of samples to be processed. The entire Worksheet may be displayed through the use of the scroll bars. Print button: It allows a printout to be made of the Worksheet with the different samples and tests used to process each one. Press the Next button (Figure 20) to continue once the Worksheet has been completed. The Reagent Layout Sheet will then be automatically displayed (Figure 22) Completion of the Worksheet via the Host computer Information can be loaded onto the Worksheet using data sent by the Host computer of the laboratory. In order to do this, the Bi-directional option in the Host window from the Configuration menu must be activated and the Triturus computer connected to the Host computer. For more details concerning connection to the Host computer, please contact with the Technical Service. Follow the steps outlined below to complete the Worksheet via the Host computer: In the dialogue box appearing on the Worksheet, press the Host button (Ref. 3, Figure 17). The program will load the information received from the Host computer with the sample identification and the tests allocated to each sample. Identification will be displayed with the circle identifying the position in the carrousel left blank. Through the Sample Loading button (Ref. 4, Figure 20), press Automatic identification. 5-12

63 Operating procedure The program reads the bar codes on the sample tubes in the carrousel. The following results are possible: - The identification of a sample received from the Host computer coincides with the identification of a sample from the carrousel. The program repositions the sample identification on the Worksheet in the position where it has been detected in the carrousel, displaying this position inside the circle that accompanies the identification. - The identification of a sample received from the Host computer does not coincide with any sample identification from the carrousel. The program deletes it from the Worksheet and no mark is sent in the results that it sends to the Host computer once a test is validated. - During automatic identification a sample has been found whose identification does not coincide with any of those received from the Host computer. The program places it on the Worksheet with the circle that identifies the position in the carrousel in red. - During automatic identification it is unable to read the identification of a sample. The program displays a window requesting manual identification of the sample. If the identification entered coincides with any of those received from the Host computer, the program displays this identification in the position of the carrousel indicated in the window on the Worksheet. If it does not coincide, it places the identification in the position indicated in the window and with the position circle in red. Finish completing the Worksheet linking the samples to the tests that have been detected in the carrousel but that have not been sent by the Host computer (red circle). Press Next and Start to begin the analysis. CAUTION! Do not use bi-directional communication with the Host computer to complete the Worksheet, if Automatic identification of the samples is not possible. 5-13

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65 Reagent layout sheet 6 REAGENT LAYOUT SHEET Once the Worksheet has been completed and the Next button is pressed (Figure 20) the Reagent Layout Sheet will be displayed, which shows the positions of the various elements that will take part in a given batch. Figure 22: Reagent Layout Sheet This window is divided into four different areas: - Carrousel: this employs colours to show the layout of the diluents, calibrators, controls, samples and predilution tubes. Placing the mouse pointer over graphic carrousel display will cause the + symbol to appear alongside which indicates the possibility to zoom in on the display. If a specific section of the carrousel is selected, an enlargement of this section will appear showing the identification and layout of the calibrators, controls and diluents. The - symbol indicates that the image can be returned to its original size. 6-1

66 Reagent layout sheet If the mouse pointer is left immobile for a few seconds over each one of the various sections that make up the graphic display, a label will appear that provides the following information: Diluent: Identification and required volume for the selected test Calibrators: Calibrator identification Controls: Control identification Samples: Sample identifying code (if there is one) and number. Remember to place the necessary disposable sample tips on the carrousel as indicated on the Worksheet. DANGER! Triturus allows the equipment s traceability to be maintained and records the expiry date. It is the OPERATOR s responsibility to input the equipment expiry date correctly. - Plates: It uses colours to indicate the number and layout of the wells on each plate required to process a batch. In the case where a batch needs more than one plate, these may be displayed independently by clicking on the corresponding button for each one of them. In the situation where the eight wells of the last row on each test are not completed, then it should be filled with empty wells to prevent spilled liquids during the wash phase. When the mouse pointer is placed over any of the plate wells, a label will appear identifying the content, calibrators, controls, the sample number, the identification code, and the sample dilution that was carried out. Locate the plates with the strip layout as indicated by the program on the loading platform. In the case where more than one plate is required, they should be stacked one on top of the other as shown in the example of Figure

67 Reagent layout sheet Figure 23: Stacked plates DANGER! It is the responsibility of the OPERATOR to use the suitable plate according to the programmed test. - Wash solutions: The equipment s five solution containers are displayed. Each one of them displays information about its layout inside the instrument, its contents, the available volume and the volume required in order to perform the programmed batch. In addition, each one provides a graphic display of the contained liquid level. The solution containers that were not used by the batch will appear in grey. If the amount of liquid held in a given container is not sufficient to complete all the work in a batch or if the waste container is excessively full, then it will be displayed on a flashing yellow background. A warning will also be displayed in the System Warning window. If the container is incorrectly positioned, then a question mark will be displayed inside its graphic representation. 6-3

68 Reagent layout sheet In a situation where these warnings are displayed, the container indicated by the program should be filled or, in the case of the waste container, it should be emptied. To do this, open the lower cover of the equipment, disconnect the tubes going to the container, remove it from the instrument and either fill or empty it. Return the container to its original position, connect the tubes according the container connection diagram and close the cover. DANGER! The waste container may contain dangerous liquids. CAUTION! For the correct operation of the levels system, the containers should be inserted until the base signal is visible. CAUTION! These containers are subjected to pressure and/or vacuum. For correct system operation, ensure that the container caps are firmly pushed in place and that the tube connections are correctly fitted. - Reagent drawer: This uses both name and colours to indicate the layout and the required volume of the various reagents on the reagent drawer tray. When the mouse pointer is placed over the reagent name, the complete identification will appear. The graphic display may show three types of icons: A green arrow on a white background: It indicates the position of a new reagent in a batch. A green arrow on a white background and green stripe: This indicates the need to add more reagent to that being used by a batch in process. A white lock on a red background: It indicates a position occupied by a reagent that is being used by a batch in process. 6-4

69 Reagent layout sheet DANGER! The reagents may be dangerous. They should be handled in accordance with the manufacturer s instructions. CAUTION! The reagents employed in this equipment should be warmed before use. Failure to do this could cause incorrect reagent mixture. In necessary case, remember to place the reagent disposable tips (1100 µl) in the reagent drawer. Once the referred reagents, samples and material have been laid-out, close the carrousel door, the reagent drawer and click on the Run button to continue (Figure 22). A window for confirming the start of the analysis will automatically be displayed. In addition, the Triturus should have four plate covers laid-out as shown in Figure 8, and it is recommended that the processed plates be removed from the position indicated in the same figure. The general door should be closed prior to confirming the start of the work batch. DANGER! The used plates may contain dangerous liquids. They should be handled in accordance with the manufacturer s instructions. If the instrument is configured to allow alternating work batches using 12-13x75 mm tubes or microtubes in the carrousel s sample positions, the program will show a window to allow choosing the kind of tube in the batch that is going to be run. Then, the equipment will commence the following checks: - That the number of sample tubes on the carrousel corresponds to the number of programmed samples identified automatically or with that manually programmed by the OPERATOR. 6-5

70 Reagent layout sheet - That the number of predilution tubes corresponds to the number programmed on the Worksheet. - That the necessary calibrators, controls, and diluents have been placed on the carrousel. - That the number of carrousel tips corresponds to that indicated on the Worksheet. - That the number of plates and wells is correct. - That the processed plates deposit is not full. - That the liquid level in the containers is sufficient to perform the batches. If the verification does not correspond to the programmed work, a warning window will be displayed indicating to the OPERATOR any deficiency encountered. The OPERATOR will have two options: Ignore or Cancel : When Ignore is selected, the instrument will begin the batch. If Cancel is selected, the batch should be verified again before beginning. The instrument will block access to the carrousel and to the reagent drawer and then initiate the programmed work. In order to open the carrousel door or the reagent drawer again, the corresponding button on the instrument s front panel should be pressed (Ref. 4, Figure 2). It is possible that the instrument will not permit immediate access because it is carrying out operations in these areas. It will therefore be necessary to wait until the current process ends. If so, a message will be displayed on the System Warning window, opening the door automatically. The main access door may be opened at any time. However, on opening, it will immediately block any Triturus operation. Ensure that it is firmly closed and that it is not opened during the processes. 6-6

71 Reagent layout sheet CAUTION! Check that there are no warning messages being displayed in the System Warning window. If the Disposed tips tray full. Please empty message is displayed, then this should be emptied. Double-clicking on the actual message removes it from the window. 6.1 Multibatch operation The program allows a maximum of 4 plates to be run in a single batch. These plates will be processed consecutively as long as the sequences of the test steps do not overlap. If this should occur, the plate will be paused until the test can be started and finished without any problems or until the previous plates have finished. To add new plates while plates are still being processed, the program will do the same thing. 6-7

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73 Status sheet 7 STATUS SHEET Figure 24: Status Sheet Once the programmed batch has been initiated, the Status Sheet will be displayed on the screen. In this sheet, each plate of the batches in execution is shown as a bar of icons that indicates constantly the state of its process (dispensing, wash, incubation, reading or well verification). The upper section of each status bar indicates the batch number, the plate number and the names of the tests that are being performed on this plate, together with the time remaining to the end of the batch. While a specific stage is being processed, the corresponding icon will be displayed on a highlighted background. If there is any variation in the incubation time due to incidents, it will be indicated by a red mark on the icon. In the event that a subincubation is produced due to programming, it will be indicated by a red question mark over the icon. Each of the icon bars contains a button at the right that enables the Reagent Layout Sheet to be displayed during the execution of the current batch. If a batch consists of more than one plate, a status bar will be displayed for each plate within the batch. The plates that are not being processed will be 7-1

74 Status sheet indicated by the corresponding icon bar and with the message Waiting and their estimated start time. Once the processing of each plate has finalised, the right button will allow access to the Results Sheet. This becomes possible when the Tests to be validated message is displayed on the lower section of the status bar. The program allows any plate to be cancelled, whether being processed or waiting to be processed. To do this, position the cursor on the status bar of the plate that is to be cancelled and right-click with the mouse. A dialogue box will be displayed with the following options: Cancel plate: A confirmation window will be displayed when this option is selected. Click on Yes to confirm plate cancellation. This confirmation window can also be reached by double-clicking on the plate status bar. Cancel: It closes this dialogue box. By cancelling a plate, the processes will be interrupted and the plate will be deposited in the processed plates deposit and deleted from the Status Sheet. The processed plates will disappear from the Status Sheet when all the tests they contain have been validated or invalidated through the Results Sheet. 7-2

75 Results sheet 8 RESULTS SHEET The Results Sheet shows the calculated values and interpretations performed on the samples once the tests on a batch have been completed. Figure 25: Batch Results window WARNING! Triturus results must be interpreted and validated by qualified personnel. This sheet is accessed by means of the right button of the status bar of a batch that will be available when all the internal instrument operations have been completed. Before declaring the results of a test to be valid, it should be verified that blank, calibrators and controls are within the established specifications and that they meet the validation conditions. The Batch Results window is structured in the same way as the Worksheet, but now the corresponding results are displayed in the selected sample boxes. 8-1

76 Results sheet By default, the results that are within the normal limits will appear on a blue background, the results that are outside the normal limits will appear on a red background, and those that are in the questionable area will appear on a yellow background. The colours of the interpretation levels can be programmed for each test. In the case where some of the samples are replicated or they have multiple or serial dilution, a small green square will be displayed in the lower right of the corresponding box. Double-clicking on the square will bring up a dialogue box with the following information: Sample identification code (if there is one), name of the test, the mean and the variation coefficient of the optical density values, the concentration, and the sample interpretation. Select the Replicates button to display the value of each one of the replicated samples. A window will be displayed containing the individual concentration and optical density values, together with a box that permits each replicated sample to be selected or deselected. A password will be required if password control is selected (see section 16.9 Password control ). The Replicates button may appear highlighted in yellow to indicate values that fall outside the allowed range during the well verification step (see chapter 12 WELL VERIFICATION). If it is thus, in the Replicates window, the program it will show a information button that allows access at these values. Right-clicking with the mouse on the box that is displaying a sample s result and then selecting the Result Sample option, allows access to this window. If a right-click is made on sample identification, a drop-down menu with the following options will be displayed: - Report: It prints out a report on a sample. - Cancel: It closes the menu. Double-clicking on its identification on the Batch Results window can also print out a sample s result. There are also six command buttons on the Batch Results window: - Test Information: It displays the specifications, the results, the calibration curve and its calculation method. - Calibrators and Controls: It shows the calibrator values and the range of the controls. - Edit O. D.: It displays the optical density values of each well on the plate. The ODs can be edited if the test was programmed with this option enabled. 8-2

77 Results sheet If the value of the optical density is modified, this one will be shown with a different colour and the change will be recorded in the registry. - Print Samples: It allows printing of the results of a specific sample or of all the samples processed in one batch. - Registry: It allows the printing out of the schedule of the various steps of the process. Further information can also be found on incidents that can occur during the batches, optical density modifications, validation of wells with an incident, and test validations. - Close: It closes the Results Sheet. Right-clicking on the test name will display a drop-down menu with the previously described options (without the Registry option). 8.1 Test Information Figure 26: Test Information Select a test and click on the Test Information button in order to find out if it fulfils the manufacturer s specifications and a window will appear containing the following sections: - Results: Displays the identifying code for each sample, the mean average optical density value, the variation coefficient and the concentration value. 8-3

78 Results sheet As each sample is selected with the mouse pointer, its position on the calibration curve is indicated by means of a red cross. When the sample is clicked again, the Sample Results information can be accessed. - Calibration Curve: The calibration curve is represented on axes, with the calibrator O.D. mean average shown on the ordinate axis and their concentration shown on the abscissa axis. If the Allow for calibrators and/or controls repetition at the end of test option is activated, the O.D. of the repeated calibrators will not be taken into account for calculation of the average. The positions of the test calibrators and controls are shown on the calibration curve by means of an identifying label. When it is a programmed Cut-Off method test, the information related to this method will appear. - Specifications: Groups together the target, control and calibrator values, and the Quality Control information. When any of these do not meet specifications, they will be shown in yellow background. If replicates of the target have been made, a button will appear with a number representing the number of replicates. - Method: It shows the method of calculation used. Is possible change it once the results have been obtained. This window also has eight buttons that are described below: - Controls - Calibrators - Validation Conditions - Quality Control - Adjustment - Invalidate - Print - Validate - Cancel Controls The mean average O.D. control values, the variation coefficient and the concentration will be displayed. If the Allow for calibrators and/or controls repetition at the end of test is activated, the mean average O.D. value, the 8-4

79 Results sheet variation coefficient and the concentration of repeated controls will be shown below (Ref. 1, Figure 27). Figure 27: Controls window When the value of any of the test control parameters falls outside the specifications, it will appear on a yellow background. This will not apply to parameters corresponding to the controls repeated at the end of the test. When any of these values does not cover the ranges specified in the well verification, the blue information button will appear next to the optical density box. If replicates have been made, a button will appear with a number representing the number of replicates. Click on the button " xn" (x1, x2, n being the number of replicates) in order to see the value of the replicates. The value of each of the replicates of controls corresponding to the test can be deactivated by means of the corresponding checkbox. If the password control is enabled, a password will be requested (see section 16.9 Password control ). If they have been processed, the external controls will be displayed differently to the internal analysis controls. Calibrators The mean average value of the calibrators is displayed in O.D., the variation coefficient and concentration. If the Visualize the results from interpolation of calibrators (see section Calculation data ), the concentration values corresponding to said interpolation will also be displayed. If the Allow for calibrators and/or control repetition at the end of test option is activated, the mean average O.D. value, the variation coefficient and the interpolated calibrator concentration will be displayed (Ref. 1, Figure 28). 8-5

80 Results sheet Figure 28: Calibrator window When the value of the test calibrator parameters falls outside the specifications, it will appear on a yellow background. This will not apply to parameters corresponding to calibrators repeated at the end of the test. When any of these values does not cover the specified ranges in the well verification, the blue information button will appear next to the optical density box. If replicates have been made, a button will appear with a number representing the number of replicates. Click on the button " xn" (x1, x2, n being the number of replicates) in order to see the value of the replicates. The value of each of the replicates of the calibrators corresponding to the test can be deactivated by means of the corresponding checkbox. If password control is enabled, a password will be requested (see section 16.9 Password control ). Validation Conditions The programmed validation conditions and the results obtained appear in this window. The validation conditions that do not meet the corresponding specifications, will appear on a yellow background. Said criteria shall not be applied to the values obtained from the calibrators and controls repeated at the end of the test when the test programming has said option activated. Quality Control Information regarding statistical rules appears in this window when the test has an associated Quality Control protocol (see chapter 13 QUALITY CONTROL). Adjustment This window allows access to the option of adjusting a previously memorized curve (this option will be described in detail in chapter 11 FITTING WITH A MEMORIZED CURVE). 8-6

81 Results sheet Figure 29: Adjustment curve window - Adjustment Curve: It allows adjustment of the test for the selected curve. In the calibration curve graph, the 2 curves that were obtained will be visible (adjusted curve and memorized curve). - Memorizing Curve: It allows the current test curve to be saved. This will save the description that was entered and a series of extra pieces of information on the curve: batch number, date, test name, and traceability information. - Edit: It allows modification of the curve description for some of the memorized curves. - Delete: It allows memorized curves to be deleted. - OK. - Cancel. Invalidate It allows the results of a test that are inadequate to be deleted. The results of invalidated tests will appear in grey. The invalidated tests appear with a red on the Batch Results window. Print It allows a printout to be made of the test results. 8-7

82 Results sheet Figure 30: Test results print out The results printout will display all the information on the test that was processed. - Heading of the printout, if it has been configured, and the processing date (Ref. 1, Figure 30). 8-8

83 Results sheet - Batch information (batch number, plate number, and test) and traceability data if it has been entered (Ref. 2, Figure 30). - Reading filters (Ref. 3, Figure 30). - Graphic with the calibration curve or Cut-Off information (Ref. 4, Figure 30). - Results of the blank (if there is one), calibrators and controls (Ref. 5, Figure 30). - Results of the statistical rules and validation conditions. - Sample results. The following indications can also appear with these results (Ref. 6, Figure 30): (*)Does not meet the QC specifications: A result that does not meet any of the programmed specifications. (**)Out of curve range: A result that falls outside the calibration curve range. (OWR) Out of reader working range: An optical density value greater than 3. Up to an O.D. of 3 it is considered to be within the dynamic range of the reader. Type of identification: (M)=Manual. (A)=Auto. (H)=Host. (R)=Repeat. Indicates how each sample has been identified. BKF=Back Fit: This abbreviation will appear when fitted curves are being used. Indicates the values that have been calculated from the adjustment. Validate It allows the results of a test to be validated. The validated tests appear with a green on the Batch Results window. On validating or invalidating all the tests in a batch will cause its status bar to disappear from the Status Sheet and will terminate the process. The results may then be revised via the Results menu. 8-9

84

85 Test programming 9 TEST PROGRAMMING 9.1 Test Programming window Figure 31: Test Programming window Figure 31 shows the Test Programming window. This is accessed via icon (Ref. 2, Figure 16) or via the main menu Programming option; if the password control is enabled, a supervisor s password will be requested. 9-1

86 Test programming CAUTION! The modification of existing tests or the creation of new ones may cause incorrect results. Test programming should be performed by the RESPONSIBLE AUTHORITY. The Test Programming window contains an organised list of tests and profiles. Click on "+" or "-" to maximise or minimise each folder. A profile is a group of already existing tests that has been given a collective name that enables them to be entered as a block onto the Worksheet. To create a new profile, click on the New Profile button and enter the profile name and then drag over it the tests that it is to contain. A folder allows a set of tests to be grouped under one name. Unlike a profile, a folder cannot be entered in one block on the Worksheet. The Copy Test option allows a copy to be made of any of the tests on the menu once it has been previously selected. Then, all the parameters can be edited and modified. Clicking on the New Test button can create a new test. The test parameters screen will be appear with all the parameters blank or pre-set. A test that already exists can be edited by selecting the test and clicking on the button marked Edit, and the same screen as in the previous instance will appear but with the current test parameters. Test parameter programming will be explained in chapter 9.2 Creating and editing tests. To delete a test or a profile, select it and click on the button marked Delete. When the Print button is clicked, a printout of the selected test programming will be produced. The buttons marked Import and Export allow the tests, folders, and profiles that have been selected with the cursor to be copied to or from other information system directories. 9.2 Creating and editing tests Test programming is performed by means of multiple windows that are accessible through their corresponding tabs: Heading, Blank, Calibrators and Controls, Samples, Steps, Calculation, Interpretation and Validation Conditions. Each successive sheet should be accessed in order and it is not possible to move on to the following one when the current sheet is missing parameters or there are incorrect ones. 9-2

87 Test programming Header data Figure 32: Test programming: Heading Name and description of the test. Correlative dispensing of samples checkbox. This option allows samples to be distributed on the plate in a correlative manner, instead of the default manner used by the Triturus analyzer. Serotheque checkbox. This option allows a Serotheque test to be performed (see chapter 15 SEROTHEQUE) Diluent allows the user to choose the type of tip to be used to dispense the diluent and also to choose one of the common diluents from the list or to define a particular diluent. 9-3

88 Test programming Double strip wells checkbox allows the user to work with double well strips. This option should be enabled if the plate being utilised has this characteristic. Control well checkbox. This option allows processing of equipment using the control antigen design. Selection of the control well automatically enables the Double strip wells option. The plate frame permits a choice between various programmed types of plate frames. It is important to correctly select the appropriate frame to each kit. It is possible to independently select between Fixed needle and Disposable tips for the sampling and reagent dosing operations. With fixed needle, it is possible to select different types of washes. The default settings are the Regular and the Strong washes. Users can define their own washes by means of the Common Reagents option. When disposable tip is selected, the reuse tips option will be enabled. The reuse of tips in samples means that the same tip will be used to prepare predilutions and to dispense them onto the plate. If there are dilutions that are shared by several tests, the tips are reused between tests. With reuse of tips in reagents, the instrument uses the same tip to dispense a common reagent in the same batch. This option can be unselected. Enter the reporting units that will be used, for example "IU/ml." Blank data This indicates the data in relation to the blank of test. It is possible to disable the blank. In the case where the blank is used, the diluent volume, the number of replicates and the maximum acceptable optical density should be indicated. A maximum variation coefficient can be programmed for the replicates. 9-4

89 Test programming Calibrators and controls data Figure 33: Test programming: Calibrators and controls Up to fourteen positions can be programmed for calibrators and controls. Calibrators The drop-down Source menu allows the user to choose the source of dilution that will be performed by each calibrator: - Cn: Each dilution is performed starting with a calibrator vial. - C1 Orig: All the dilutions are performed starting with a single calibrator vial. - Cn-1: A dilution of the previous calibrator is performed. - N/A: This calibrator will not be used. The program for each calibrator, in addition to the source, allows the programming of the dilution (x:yyy), the volume to be dispensed in the well, the number of replicates, the maximum variation coefficient that is 9-5

90 Test programming acceptable if there are replicates, a description and the minimum optical density that is acceptable. In order to enter more than 5 calibrators, use the movement buttons. Controls It allows the user to define for each control the dilution to be performed, the volume to be dispensed in the well, the number of replicates, the maximum variation coefficient that is acceptable if there are replicates and a description. In order to enter more than 5 controls, use the movement buttons Sample data The dilution, the volume to be dispensed in the well, the number of replicates and the maximum variation coefficient that is acceptable may be programmed Data for the steps to be performed Figure 34: Test steps programming 9-6

91 Test programming To the right of this sheet is a list of the steps that may be performed on a plate within the instrument, and to the left is the sequence of test that have been selected. The selectable steps may be dragged and inserted into the required position on the left-hand side sequence. During execution of the test, this sequence is performed from top to bottom. Some steps have parameters that can be edited, which should be defined when a step is added to a sequence. Once added, they can be modified by right-clicking with the mouse on the step and selecting Edit. To delete a programmed process, select it and press the delete key or rightclicking with the mouse and select Delete. Sample pretreatment: This process allows the sample to be treated with a pretreatment solution in a predilution tube. By selecting this option, the programme offers the option of selecting the name of a pretreatment solution from a list of common pretreatment solutions, or entering a specific one. It allows the proportions to be entered, among volume, microlitres, sample and pretreatment solution to be dispensed in the predilution tube. In addition, dispensing of said solution to the blank, calibrators, controls and/or samples (all or specific ones) can be deactivated. The programme only allows a single sample pretreatment process to be programmed. Incubation of predilution tube: This process allows programming of the time, in minutes, for incubation in the predilution tube. Such incubation is done at room temperature and without agitation of the predilution tubes. Sample dilution: There are no programmable parameters. This process performs dilution of calibrators, controls and/or samples. Programming this process is essential, independent of whether or not there calibrator, control and/or sample dilution. Sample dispensing: This does not have any programmable parameters. This process dispenses the blank, calibrators, controls and samples, or their respective dilutions, to the plate according to the test programming. The sample pretreatment, incubation in predilution tubes and/or sample dilution processes cannot be programmed after the sample dispensing process. Well verification: This step makes it possible to control dispensing in some of the test steps. If the established range does not meet, the wells will be treated as incidents, and a specific procedure should be followed to validate them (see chapter 12 WELL VERIFICATION). 9-7

92 Test programming The user can enter a description of the step, the primary and secondary filters to be used, establish an optical density range that the reading should meet and select whether said verification should be done on the blank, calibrators, controls and/or samples (any or all.). Conjugate addition: The name of a conjugate may be selected from a list of common conjugates, or a specific one may be introduced. It allows introducing the conjugate volume to be dispensed. The dispensing of the conjugate into the blank, calibrators, controls and/or samples (all of them or specific ones) can be disabled. Substrate addition: The name of a substrate may be selected from a list of common substrates, or a specific one may be introduced. It allows introducing the substrate volume to be dispensed. The dispensing of the substrate into the blank, calibrators, controls and/or samples (all of them or specific ones) can be disabled. Stop addition: The name of the stop solution may be selected from a list of common stop solutions, or a specific one may be introduced. It allows introducing the stop solution volume to be dispensed. The dispensing of the stop solution into the blank, calibrators, controls and/or samples (all of them or specific ones) can be disabled. Incubation: The time in minutes, the temperature in ºC and plate shaking during the incubation period may be selected. It also allows you to select when to start counting the incubation time. If the previous step is a reagent addition or a sample dispensation and the following incubation is at room temperature there are two possibilities, to start when the last well on the plate has been dispensed or to start once the first well has been dispensed. CAUTION! Bear in mind, especially for incubations at room temperature, that the temperature inside the equipment can exceed up to 3ºC the outside temperature. For this reason, incubations at temperature higher than desired, can be expected if the outside temperature is close to the selected incubation temperature. Washing:Type of wash may be selected from a predetermined list. Reading: The primary filter, and the secondary one if dichromatic reading is required, may be selected from the list of installed filters. 9-8

93 Test programming Calculation data This allows the selection among three possible calculation methods: - Cut-Off method: The Cut-Off value should be entered directly or via formula. The Cut-Off formula is a mathematical expression consisting of operators, variables, constants and brackets. Valid operators are: * : Multiplication. / : Division. + : Addition. - : Subtraction. () : Brackets. Acceptable variables are: B: Represents the mean average O.D. value of the target. C: Represents the mean average O.D. value of the calibrators. Cn : Represents the mean average O.D. value of calibrator 'n'. CnRx: Represents the O.D. value of replicate 'x' of calibrator 'n'. CO: Represents the mean average O.D. value of the controls. COn: Represents the mean average O.D.value of control 'n'. COnRx: Represents the O.D.value of replicate 'x' of control 'n'. S: Represents the mean average O.D. value of each sample. The use of upper or lower case letters makes no difference. Constants may be real or integers, using decimal dot notation (.). For example: 5,.5, 0.5. Any number of brackets may be used, provided that they are correctly nested. In this way an example formula could be: 0.5*(C1+C2) 9-9

94 Test programming The previous formula indicates that the Cut-Off value shall be the result of multiplying the sum of the mean values of O.D. of calibrators 1 and 2 by 0.5. Additionally, the Index formula option can be enabled. The index allows for quantification of the samples. By default, the formula is programmed: S/CUTOFF. This formula can be modified, and the valid operators and acceptable variables will be the same as those for defining the Cut-Off. Additionally, the CUTOFF variable may be used. For example, if the Cut-Off formula is 0.5*(C1+C2), in the index formula it can be used S/CUTOFF since it is equivalent to use S/0.5*(C1+C2) Through the Info button, information of the operators and allowed variables is obtained. The program checks that all the variables defined in the formula are compatible with the test and it also checks its syntax. If there is any error, a warning message is displayed. Single point method: It calculates the results by multiplying the test calibrator concentration by the quotient resulting from dividing the absorbance value obtained for a sample and the absorbance value obtained for the same calibrator. Curve interpolation method: This allows the introduction of a calibration curve with eight possible calculation methods: Point-to-point, Linear regression, Polynomial regression, Cubic spline, 4PL, Lin-Log, Log-Log and Logit-Log. The Visualize the results from interpolation of calibrators option displays, in the test results, the calibrator concentration value obtained from interpolating the respective O.D.s onto the calibration curve. This option is valid for the following calculation methods: linear regression, polynomial regression, 4PL, Lin-Log, Log-Log and Logit-Log Interpretation data Qualitative interpretation: A sample interpretation can be selected as positive for values greater than the Cut-Off and negative for lesser values and vice versa. A borderline can be entered around the Cut-Off. 9-10

95 Test programming Figure 35: Test programming: Interpretation Quantitative interpretation: Up to 5 levels of interpretation can be entered. It is necessary to define, as a minimum, the ranges for the positive and negative interpretations. In this case, the area contained between the two values is, automatically, considered as the indeterminate area. The defined colour in each level can be changed by double-clicking on the square that it shows the colour selected by default. Only when using the Cut-Off method with an index the user can choose between a qualitative or quantitative interpretation. One or the other will be disabled when using other methods. 9-11

96 Test programming Validation conditions data Figure 36: Programming Validation Conditions Up to 10 different validation conditions can be programmed in this window. Different validation conditions can be listed in each box by separating them with a comma. In each validation condition, it should be specified if the variables make reference to the optical density or the concentration. In addition to the operators and variables described in the Cut-Off section, the following logical operators are also valid: 9-12

97 Test programming > greater than. < less than. >= greater than or equal to. <= less than or equal to. = equal to. Using the Info button, information is obtained from the operators and allowed variables. This window also allows you to select the Quality Control protocol to be linked to the test. The protocols previously defined in the Quality Control menu will appear on the list (see chapter 13 QUALITY CONTROL). Three more parameters to be selected for the test are found in this window: - Permission to validate with results out of the specifications In the test results, the Validate button will appear as enabled even if the specifications do not meet. - Permission to edit optical densities It allows modifying optical densities in the test results. - Permit adjustment of a memorized curve The test curve can be adjusted to another that has been previously memorized. - Allow for calibrators and/or controls repetition at the end of the test. For each test, when dispensing to the plate, calibrator and/or control dispensing will be repeated after having dispensed all of the samples. The repetition will be done using the same order and the same number of replicates used when programming the test. Calibrators and/or controls repeated at the end of the test cannot be used as variables in the validation criteria. 9.3 Wash programming Using the Wash Programming button in the Test Programming window (Figure 31), the user can create, modify, or delete the preset washes that appear when a test is programmed. 9-13

98 Test programming Figure 37: Wash Programming Clicking on the Edit or New buttons will display the window of Figure 37 and this permits the wash type to be defined with the following parameters: - Wash Name, with which it is identified on the predefined list of wash operations. - The names of solution 1 and of solution 2, which can be selected from a list of common solutions, or specific ones may be defined. - The lower box shows the wash cycle sequence that makes up a wash type. The sequence is configured by means of the New, Copy, Edit or Delete buttons and the parameters are programmed for each cycle. 9-14

99 Test programming Figure 38: Wash Cycle Programming Figure 38 shows the window displayed when editing or creating a cycle. The wash solution used during the cycle may be selected (from the two predefined in the previous window and distilled water), together with the aspiration time, corresponding to the disposal of the liquid present in the plates when the wash is commenced. The normal wash cycle consists of sucking up the liquid from the plate, dispensing a volume of wash solution, allowing a soak time and then sucking this up. All these parameters are OPERATOR-programmable. The continuous wash cycle consists of sucking up the liquid from the plate and then, for a fixed amount of time, the dosing and suction, at the same time, of the wash solution from the upper part of the well in order to obtain an intense washing of the well walls. After the soak time, the liquid is finally emptied from the plate. This form of washing however, consumes more wash solution than the normal wash. 9-15

100 Test programming The dispense time of the continuous wash and soak time parameters are programmable. When wash by strips is selected, all of the cycles of a wash will be performed on one strip before continuing on to the next. Once wash by strips is selected, the Not leaving the wells empty in the last cycle option will allow the wells to remain full in the last wash cycle. Once the wash is finished, the liquid of the all wells are aspirated. 9.4 Common reagent programming The Common Reagents button in the Test Programming window (Figure 31), permits the creation of lists of reagents common to several tests that are displayed as predetermined in the various programming steps. Common reagent programming is performed starting from eight windows that can be selected in the upper tab (Figure 39). Figure 39: Common Reagent programming The method of including a reagent in one of the common reagent tables is the only way that the program will recognise that two tests share the same reagent and will only request a single container with the reagent in order to perform the two tests at the same time. Through the use of the New or Delete buttons, the list of common reagents may be updated for diluents, wash solutions, frames, conjugates, substrates, stop solutions, probe washings and pretreatment solutions. Note that the plate frames are considered to be sharable items. When the plates are removable and the same type of frame is used by several reagent units, the program will allow the strips for different tests to be placed in the same frame, which will optimise the instrument capacity and speed. 9-16

101 Test programming In addition, it is possible to configure the specific sizes of each frame or plate on the plate frame sheet. Adjustment of a new plate Each time a new frame type is incorporated into the Triturus frame base, an adjustment should be carried out that assures the correct emptied of the wells. If an existing frame is to be configured from the list of frames in the common reagent base, first select the frame and then click on the Configure button. When a new frame is to be introduced, click on the New button, then enter an identifying name for this frame, and click on OK. In both cases, a screen will be displayed requesting the manual entry of the plate and its frame in the washer. Open the Triturus general door, correctly position the plate on the washer base and then click on the Next button. This new screen is used to adjust the washer manifold inside the wells. There are four buttons in the window, which are used to control the position of the washer manifold and the plate carrier: - Number of steps: The amount of steps to be moved by the system, each time a movement button is clicked (approx. 7 steps per mm for the manifold and 10 steps per mm for the carrier). - Number of steps moved by the manifold: The amount of steps done by the manifold from its original position. - Number of steps moved by the plate carrier: The amount of steps done by the plate carrier from its original position. Enter a value for the number of steps, (a value of 5 is recommended when starting the adjustment). By using the on-screen control buttons, position the manifold so that the long capillaries are close to the well wall, but without actually touching it. If an accurate adjustment is required, then enter a value of 1 for the number of steps and continue with the adjustment. You can also disable the carrier movement during the aspiration cycle. 9-17

102 Test programming Figure 40: Normal wash adjustment Once the frame is correctly adjusted, click on Next. The new screen can be used to check the adjustment with a standard wash or one from the program base. Perform the wash and, if a fine frame adjustment is necessary, go back to the previous window and repeat the process. Then click on Next and new screens for continuous wash adjustment will be displayed. By following the same procedure previously described, adjust the manifold so that the long capillaries are 1 mm below the upper part of the well and, after checking for correct operation of the continuous wash, click on Done. Figure 41: Continuous wash adjustment 9-18

103 Test programming A warning will be displayed, requesting the removal of the frame from the washer, do so and then click on OK. Probe wash This tab allows the kinds of probe washes to be added or modified. Figure 42: Probe wash programming When a new wash is introduced or one is modified, the name and strength of the wash can be specified. Strength is defined by the factors (x1, x2..., x10) directly related to the volume of the saline solution used in the wash. Specifically, x1 equals to 250 l of saline solution. 9-19

104

105 Revision of the executed batches 10 REVISION OF THE EXECUTED BATCHES The program automatically saves all the batches carried out by the Triturus. Figure 43: Revision of the executed batches Using the Results option on the main menu, two options can be accessed: - Results by Batch (also selecting the icon Ref. 3, Figure 16). - Export Results Results by batch When this option is selected, a list of the batches that have been processed will appear. Each batch is identified by its number, date, the time of processing, and the names of the tests used in it. The batches that have an asterisk and are in grey are being processed or are awaiting validation in the Status Sheet or are being read. An access to the Results Sheet described in chapter 8 RESULTS SHEET can be made by selecting any batch without an asterisk, continuing in a manner similar to that described in the mentioned chapter. 10-1

106 Revision of the executed batches 10.2 Export results This option allows the user to export the results of batches processed with the Triturus to other programs that accept text file format separated by commas. Select the batches that are to be exported and click on OK. Give the exported file a name. Once the data has been exported, they will be arranged in a set of fields described as follows: ld_triturus: It displays the identification of the instrument. This identification is the one established in the Host's configuration window (see Figure 69). Date: It displays the date on which the batch was processed. Time: It displays the time at which the test was processed. Batch: It displays the batch number. Plate: It displays the plate number. Test: It displays the name of the test. Lot: It displays the lot number of the kit that was processed if this parameter was entered in the traceability. Expiry: It displays the expiry date of the lot if this parameter was entered in the traceability. User: It displays the name of the user if this parameter was entered in the traceability. Well: It displays the well number in the plate. Type: It displays the type of well, B=blank, C=calibrator, C(F)=calibrator repeated at end of test, CO=control, CO(F)=control repeated at end of test, S=sample. Num_Sample: It displays the sample number, calibrator or control. Id_Sample: It displays the sample identification. Replicate: It displays the replicate number. Dilution: It displays the dilution used in each case. OD: It displays the optical density value that was obtained. OD_Mean: It displays the average optical density value. OD_CV: It displays the variation coefficient for the optical density values among the replicates. 10-2

107 Revision of the executed batches Concentration: It displays the value of the final calculated concentration. Backfit: Indicates the calibrator concentration value obtained from the interpolation of its O.D. value onto the calibration curve. Corrected: It indicates whether the final concentration has been corrected (see chapter Replicates window ). Interpretation: It displays the interpretation of the results. Units: It displays the units that are used in each test. Method_Calculation: It displays the method of calculation that was used. 10-3

108

109 Fitting with a memorized curve 11 FITTING WITH A MEMORIZED CURVE 11.1 Description This option allows the user to memorize a test curve, which can later be used with tests in which not all of the calibrators have been processed Memorizing In order to perform this type of fitting, the curve that will be used as a model should already be memorized. Figure 44: Curve memorizing - To memorize a curve, click on the Fitting button from the Test Information window. A new window with the list of memorized curves will appear. Click on Memorizing Curve and enter a descriptive name. In addition to the name of the curve, the batch number, the date, the test name and the lot identification, entered by the user, will also be recorded. Once a curve has been memorized, it will be available to make tests with this type of adjustment. 11-1

110 Fitting with a memorized curve 11.3 Fitting with a memorized curve To do this, starting at Test Programming, enable the following option: - Permit fitting with a memorized curve. When the test is loaded onto the Worksheet, the calibrators and controls window will appear. Figure 45: Calibrators and controls selection The checkboxes allow the user to unselect the calibrators that the user decides not to process. The test will only be processed with the calibrators that remain selected. If the Allow for calibrations and/or controls repetition at the end of the test option is activated, the only selection allowed will be repetition of those calibrators selected to process the curve. Once the results are obtained, click on the Fitting button, select the memorized curve, and then click on Fitting Curve. The two curves will appear in the calibration curve window: 11-2

111 Fitting with a memorized curve - The memorized curve in red. - The fitted curve in black Messages While the fit is being calculated, the following error messages may appear: The number of calibrators is higher than in the memorized curve. For example, a test with 4 calibrators is processed with the 4 calibrators selected. The results attempt to fit with a memorized curve from a test that was processed with 3 calibrators. There are calibrators that do not correspond with the memorized curve. For example, in a test with 5 calibrators, only three are selected, C1, C2, and C5. The final result attempts to fit with a memorized curve that was processed with a test with 4 calibrators, C1, C2, C3, and C4. There is no value corresponding to C5. Error, concentration out of the range of memorized curve. This error appears when a fitting is made with calibrators that they have different concentrations respect the memorized curve and the interpolation is outside the rank of the curve. It is not possible to adjust a curve with a negative slope to one with a positive slope. When a curve with a negative slope is fitted to a curve with a positive slope or vice versa. If any of these error messages should appear, the curve cannot be fitted Results Once the curve has been fitted, the results may be printed out to display the following information: - (Ref. 1, Figure 46) Graph with the representation of the memorized curve and the fitted curve. - (Ref. 2, Figure 46) Method of calculation, which shows the curve to which the results have been fitted. - (Ref. 3, Figure 46) Calibrator column. Test calibrators that were not processed and are to be calculated from the memorized curve will appear in parentheses. - (Ref. 4, Figure 46) Memorized optical density column. It shows the optical density values for the memorized curve. - (Ref. 5, Figure 46) Optical density column. It shows optical density values for the fitted curve. - (Ref. 6, Figure 46) Average optical density column. It shows the average optical density for each calibrator. If the calibrator was not processed 11-3

112 Fitting with a memorized curve and it is to be calculated from the memorized curve, the indication BKF (back fit) will be displayed next to the optical density value. Figure 46: Print test with fitted curve 11-4

113 Well verification 12 WELL VERIFICATION 12.1 Description This step permits a reading to be made during processing of a test that allows verifying the correct dispensation (of samples or reagents) Programming the step Add this additional step during test programming. The software displays a window with the following sections: Description: Allows a description to be established of the well verification steps. Selection: Allows deactivation of the blank, calibrator, control and/or sample verification. Filters: Allows selection of the filters (primary and secondary) to be used by the analyzer to perform the O.D. reading on the wells selected in the above section. Optic density range: Allows entry of the O.D.s for which the wells being checked should be found. Calculation method: Allows establishment of the reference value from which the O.D. range has been defined, in the event of differential well verifications. If no option is selected, the verification will be carried out using only each well s O.D.s. When programming the test, more than one well verification process can be programmed, whether consecutively or in different stages of the test Execution of step The Status Sheet shows information on the well-verification step during test processing. If all wells are within the established range, the processes will continue as programmed once the reading terminates. If any well is not within the established range, the verification will be marked with a red cross. To obtain information on the verification step, place the cursor over the icon (Ref. 1, Figure 47) and press: 12-1

114 Well verification Figure 47: Well verification A window with the following information will open: Well outside the programmed range of optical density, descriptive name of step, filters used in reading, range entered and optical density value obtained. Figure 48: Well verification information If the verification step is not satisfied after dispensing reagents and the option Automatic cancellation of samples after pipetting errors is not activated in the Miscellaneous menu, Dilutor, a window will open for a minute to allow the OPERATOR to press OK to enable manual dispensing. 12-2

115 Well verification Figure 49: Error well verification 12.4 Results Once results are obtained, all wells that are not within the range of any well verification will be marked as cancelled with a highlighted colour. Figure 50: Well verification results In each of these wells, an information icon summarising well incidents appears. The user should decide whether accept the results of these wells or not. 12-3

116 Well verification If the test is validated, the wells with incidents that have not been activated will be cancelled definitively. Before validation, a warning will appear if all the incidents have not been reviewed. Once a test is validated, the information corresponding to well verifications is lost. This will only be recorded in the Registry, where the incidents of each step and well validations with incidents are noted. 12-4

117 Quality control 13 QUALITY CONTROL 13.1 Analysis Quality Control The Triturus Quality Control program allows assessing the certainty of the results obtained in the analysis. To do so, controls are established in the internal and external parameters of the test. A system for obtaining charts is also established. This allows studying the evolution of the data through successive analyses Internal parameters In order to establish the controls in the internal parameters of the tests the program allows programming for the blank, controls and calibrators the following specifications: Blank: - The maximum optical density. - The maximum CV in the case of existing replicates. Calibrators: - The minimum optical density allowed for each calibrator. - The maximum CV in the case of existing replicates. Controls: - The valid range of optical densities or concentrations for the results of each internal control. - The maximum CV in the case of existing replicates. It also enables setting certain Validation Conditions (see section Validation conditions data"). These specifications are programmed from the Test Programming window. Once the test has been processed, the program shows, in the Test Information window and on a yellow background, the parameter that does not comply with the programmed specification External parameters These parameters are formed by the external controls. These controls are processed in the Triturus as if they were samples. Certain statistical rules are applied to the results. These rules analyse their behaviour regarding other controls results in the same analysis and regarding results from previous analyses. The external controls are programmed in the Quality Protocol window. The external controls are assigned in the configuration of the Worksheet. 13-1

118 Quality control The result of applying the statistical rules to the values of the external controls is shown in the Test Information window. If any of these rules are not obeyed, the Quality Control button in this window appears in yellow Statistical rules These rules are decision algorithms for establishing the limits within which the results of the external controls should fall. The rules that can be programmed in the Quality Protocol are: - Rule 1 2s: It checks if any of the external controls exceeds the mean by twice the standard deviation, up or down. - When a value fails to comply with this rule, the remaining rules programmed are applied automatically. An alarm rule is considered. - Rule 1 3s: It rejects a test when an external control exceeds the mean by three times the standard deviation, up or down. - Rule 2 2s: It rejects a test when two external controls exceed the mean by twice the standard deviation in the same direction. This rule is applied first to the controls of one test and, whenever necessary, to two values of each control over consecutive tests. This rule is used to detect systematic errors. - Rule R xs: It rejects a test when the difference between two external controls exceeds the standard programmed value of 'x' standard deviations. This rule is only applied to one specific analysis and is used to detect random errors. - Rule X 1s: It rejects a test when X consecutive external controls are on the same side of the mean and exceed the value of a standard deviation. This rule is applied first to the external controls of one test and, later, to the values of each control of previous consecutive tests. This rule detects systematic errors. - Rule Xx: It rejects a test when X consecutive values are situated on the same side of the mean. This rule first seeks among the X external controls from the current test back and, later, among the X values of each control of previous consecutive tests. This rule detects systematic errors. When programming the rules, bear in mind that their running may vary, depending on the number of external controls. For example, rule 4-1s is applied to one analysis only if four external controls have been programmed, or to two analyses if the number of controls is a half. 13-2

119 Quality control Reports Quality Control also allows evaluating the quality of the results of an analysis through the study of the evolution of its parameters in previous analyses. To do so, the Triturus program allows reports to be obtained with the following charts: - Evolution of the optical density in an interval of performed tests. This chart can be shown for the blank, calibrators and controls. - Evolution of the concentration in an interval of performed tests. This chart can be shown for the internal and external controls. - Levey-Jennings. These represent the number of a control's standard deviations from the mean in an interval of tests performed. - Cusum. It is similar to a Levey-Jennings chart but the number of a control's standard deviations from the mean is added to the previous value if this number exceeds 0.5. The accumulated value is set to zero when the value of the control changes side of the mean. - CV in an interval of performed test. This chart can be shown for the blank, calibrators and controls Programming the Quality Protocol Defined in the Quality Protocol are the external controls to be used and the statistical rules to be applied to said controls. Figure 51: QC Protocols window Upon selecting QC Protocols from the Quality Control option of the main menu the window will appear with a list of the programmed protocols and with the New,Edit and Delete options. (Figure 51). Upon pressing New or Edit a window with three tabs will appear: 13-3

120 Quality control - Heading: It enables entering the name and description of the Quality Protocol. - External Controls: It enables programming the name of the external controls and maximum permitted CV if they are used in replicates. This window, also, enables configuring the system the program will use to calculate the mean and standard deviation used in the statistical rules and if the values used for the calculation concern the optical density or concentration. Figure 52: Programming the external controls Calculate the mean and SD with the values in the same lot number. The calculation is made with the values of the external controls of the same lot. Calculate the mean and SD with the last N values. The calculation is made with the values of the N ' last determinations of each external control. Use the mean and SD entered by the user for every control. The mean and standard deviation are entered by the user when selecting the external controls in the configuration of the Worksheet. - Multirules: This window enables programming the statistical rules to be applied to the external controls. 13-4

121 Quality control Figure 53: Programming the statistical rules CAUTION! It is the responsibility of each laboratory to define the most appropriate quality protocol in each case Assigning the Quality Protocol to a test For a Quality Protocol to be applied to the results of a technique, it should already have been selected in the programming of said test. To make this selection during the programming of the test, select a protocol from the QC Protocols list shown in the Validation Conditions window. A Quality Protocol can be assigned to different tests Identifying the external controls. The external controls are placed in positions of the crown of samples on the carrousel. During configuration of the Worksheet, the user should identify 13-5

122 Quality control these positions with the external controls with which the test's Quality Protocol has been programmed. On the Worksheet, select the position of the sample containing an external control. Without moving the cursor from the box, press the right hand button of the mouse and, from the list, select the External Control option. Figure 54: Identifying an external control The program shows the window for configuring the external control. (Figure 55). From the list, choose the control corresponding to the selected position and enter the lot identification and expiry date. If when programming the Quality Protocol the Use the mean and SD entered by the user for every control option was selected, then, enter the value of the mean and the standard deviation of the external control. Repeat these steps for all the external controls to be processed. 13-6

123 Quality control Figure 55: Configuration of the external control Results of the Quality Protocol Once the test has been processed, access to the window of the results of the Quality Control will be gained using the Quality Control button in the Test Information window. Shown in this window is the name of the Quality Protocol and the statistical rules programmed. For each external control it shows the name, value of the concentration or optical density obtained, the number of standard deviations of this value regarding the mean, the mean, the standard deviation and the number of previous results used in the calculation. It also shows if the result is ACCEPTED or REJECTED depending on whether or not it complies with the statistical rules. Upon revising the result of the Quality Control of a previous series, the value of the mean and of the standard deviation of each external control may have varied due to later series. In order to revise the results as they were shown at the time the test was validated, de-select the Calculate the mean with the latest validated values option. The window showing the results of the Quality Control also enables obtaining a report with the Levey-Jennings charts and a report with the Precision Profile chart. 13-7

124 Quality control Figure 56: QC Results Levey-Jennings: This shows the evolution of the value of all the external controls processed in the test throughout the determinations that have been used for the Quality Control calculations. For each chart, represented on the Y-axis is the number of standard deviations by which the external control differs with regard to the mean. Shown on the X-axis is a reference to the series to which the external control used for the calculation belongs. Precision Profile: It shows the value of the CV of the replicates of the samples, of the internal controls and of the external controls with regard to its values of concentrations. If the test has been processed without replicates, the Precision Profile button remains disabled. Upon validating a test, its parameters are stored in the Quality Control database. The calculations of the mean and standard deviation are made from the information in this database. 13-8

125 Quality control Figure 57: Levey-Jennings charts 13-9

126 Quality control 13.3 Obtaining reports To configure Quality Control reports, select Reports in the Quality Control option on the main menu. The program shows the window of Figure 58. Then, select the test and the type of reagent to be studied. In each selection it shows a window for identifying the selected reagent, for selecting the search interval and for selecting the type of chart. Figure 58: Selecting the test and the reagents The reagent is selected from a list showing the available reagents in the selected tests. For example, for a test with two internal controls, it allows choosing between CO1 and CO2. The selection of the search interval of data about the selected reagent allows the following options: - By lot ID: The chart will show the data of one lot. Upon selecting this option, it activates a list that allows selecting the lot number. - In the last 'N' run tests: The chart will show the data of the last N test performed. Upon selecting this option, it activates a field for entering the number of tests. - All run tests: The chart will show the data of all the tests performed. - By interval of time: The chart will show the data of the tests performed in the specified interval of time. Upon selecting this option, it activates the fields for entering the start and end dates

127 Quality control Figure 59: Configuration of the report The selection of the type of chart offers the following options: - Optical density evolution. - Concentration evolution. - Levey-Jennings. - Cusum. - CV evolution. If the selected reagent of a test for drawing up the report is the Internal Control and the search interval is for data of the same lot, in the charts of Optical density evolution and Concentration evolution then it shows the lines representing the range of said controls. If the selected reagent is the External Control and the search interval is for data of the same lot, then upon activating the Use the mean and SD entered 13-11

128 Quality control by the user option, in the Levey-Jennings and Cusum charts, the value of the mean and the standard deviation is not the one calculated by the program but the one entered by the user. The configuration of the Quality Control report for the samples allows selecting the interval of concentrations or the level of interpretation with which the samples of the report have to comply. The program will show a chart where the Y-axis represents the percentage of samples compliant with the selection criteria and the X-axis represents a reference to the series of the test compliant with the search interval. Upon pressing Print Report, the program will show a window with all the selected reports and allow them to be sent to the printer Other options of the Quality Control menu Regenerate Data: When eliminating a batch, the results are not eliminated from the database that is used for the Quality Control. This option allows create again this base from the data of the series available. Reset Rules: In the application of statistical rules(see section Statistical rules ), if a result is rejected but the root cause has been solved, it is necessary to start collecting new data to calculate the mean and the standard control deviations according the new conditions. This option allows the program to begin collecting data later subject to the application of statistical rules. However, the data obtained up to that moment will remain in the program database, their visualization being available through Quality Control reports (13.3 Obtaining reports )

129 Quality control Figure 60: Quality Control report 13-13

130

131 Multiple and/or serial dilution of samples 14 MULTIPLE AND/OR SERIAL DILUTION OF SAMPLES This option permits more dilutions than programmed in the test to be made. This option is accessed through the Worksheet when a batch is programmed Programming multiple or serial dilution Once the sample is selected in the Worksheet, press the right mouse button and choose the Multiple Dilution option. Figure 61: Multiple dilution option 14-1

132 Multiple and/or serial dilution of samples The following window will open: Figure 62: Programming multiple dilution The first dilution of the sample is the dilution programmed in the test and it cannot be modified. To add new dilutions, fill out the corresponding controls: Source: The dilutions to be programmed can come from two different sources: - Sample: The different dilutions are processed from the original sample. - DIL X: The different dilutions are processed from dilutions of the original sample. Dilution: Enter the factor of the dilution to be made. Volume: Enter the volume of the dilution to be dispensed into the well. Replicates: Enter the number of replicates. Once a range of dilutions in a sample is programmed, it can be recorded for repetition with any or all of the samples. Once the desired dilutions for a sample are programmed, press Copy dilution and OK to close the window. Select the next sample, press the right mouse button and select Apply dilutions to this sample or Apply dilutions to all samples, as desired. Paste dilution can also be selected through the multiple dilutions window described above. In the Worksheet, samples with multiple and/or serial dilution will be marked with a dot in the lowest right part of the box. On the Reagent Layout Sheet, the programmed dilutions can be seen by placing the cursor over the well on the plate map. 14-2

133 Multiple and/or serial dilution of samples 14.2 Results Replicates window The test results for each of the different dilutions are shown in the replicates window. To access to this window, double-click on the sample box in the Batch Results window. The Result Sample window will then open. Press the Replicates button. The Result Sample window can be accessed by selecting the sample box, pressing the right mouse button and selecting Result Sample. Figure 63: Multiple dilution results The default result active is of the programmed dilution of the test. To perform the interpretation using other programmed dilutions, mark the corresponding selection box. Only one programmed dilution can be left activated as the final result. The Apply dilution factor option will appear by default. This option allows the concentration to be multiplied by the corresponding dilution factor. The Dilutions button is used to access to the information on the programmed dilutions Optical density editor In the optical density editor, when placing the cursor over each well label, the dilution used in each case is shown Printing results When printing results from the Test Information window, the concentration used is of the selected dilution in the replicate window. 14-3

134 Multiple and/or serial dilution of samples Figure 64: Print multiple dilution results Through Print Samples in the batches results window, the concentration of the dilution selected in the replicate window is printed if there are multiple sample dilutions. If the Print multiple dilutions option is activated, the concentrations of all programmed dilutions are printed (Ref. 1, Figure 64) indicating the dilution selected (Ref. 2, Figure 64) in the replicate window. 14-4

135 Multiple and/or serial dilution of samples In these reports, samples with a selected dilution that is different than the one programmed in the test, and the Apply dilution factor option, will be marked with the symbol to the left of the numeric value. If the Apply dilution factor option is deactivated for said samples, they will be marked with a symbol Exporting results In exporting results, all dilutions programmed for each sample and corrected concentrations are specified. 14-5

136

137 Serotheque 15 SEROTHEQUE 15.1 Description This option makes it possible to transfer a volume of liquid from the sample tubes in the carrousel to a 96-tube plate (Ref. 1, Figure 65) positioned in an adapter (Ref. 3, Figure 65) in the reagents drawer (Ref. 2, Figure 65). It also provides a means of obtaining a report showing the position of each sample on the plate and the volume dispensed. The procedure for working with a Serotheque is similar to that used for processing a test, i.e. Test Programming, Worksheet configuration and processing. Figure 65: Serotheque plate positioning 15.2 Programming In the Test Programming window, select the New Test option. In the heading, enter a name for the purposes of identification and select the Serotheque option. The program automatically disables all the options that are not related to the Serotheque.. In order to make subsequent sample identification easier, it is possible to use the Correlative samples dispensation option to configure the Triturus to distribute the samples in a correlative manner on the plate, instead of performing default distribution. Next, select the type of tip for the instrument to use in order to transfer the sample. In the case of the Fixed needle option, the type of wash must be selected. 15-1

138 Serotheque The parameters in the Blank, Calibrators and Controls windows are disabled. In the Samples window, it is possible to program the volume to be transferred from the sample tubes to the positions on the tube plate. The available range is from 10 to 1000 µl. The number of replicates can also be programmed. All the parameters in the Steps, Calculation, Interpretation and Validation Conditions windows are disabled. Click on OK to conclude the programming of the Serotheque test Processing The first step in Serotheque processing consists of configuring the Worksheet. Identify the samples in the carrousel (see chapter 5.2 Worksheet ). Drag the Serotheque test from the test menu to the Worksheet. Select the samples from which a certain volume is to be transferred to the tube plate and click on Next. Position the adapter and the tube plate in the reagents drawer. If the test has been configured for dispensation by means of disposable tips, place the tips in the carrousel. Click on Run to begin processing the Serotheque. For the Serotheque, the Triturus can use disposable 300 µl or 1100 µl tips. In order to optimise the process time, it is recommended that 1100 µl tips be used. Contact your distributor for this. The Triturus begins the process by detecting the presence of the samples in the carrousel, of the adapter for the tube plate and of the disposable tips, if the test has been configured for dispensation using this kind of tips. If detection is completed successfully, the transfer of the liquid will begin, and the Serotheque status bar will be shown on the Status Sheet. If detection is not successfully performed, the differences found in comparison to the Worksheet will be shown Report Once the Serotheque has been completed, the program allows access to the tube plate map, which shows the position of the sample and the volume transferred. The sample s identification can be viewed by placing the cursor on the box that indicates its position. This information can be accessed by means of the button located on the right of the status bar. 15-2

139 Serotheque When Print is selected, the program shows a window that contains the data sent to the printer. This data consists of the date of processing, the batch number, the plate number and the tube map, which shows the position of the sample, its identification and the volume transferred. Once the data has been displayed, the Serotheque status bar disappears from the Status Sheet Viewing reports In order to view the data again, go to the main menu and select Results, followed by Serotheque. The program displays a window containing a list of all the Serotheques that have been processed, from which it is possible to review each one s tube map and report printout Exporting results In order to export the Serotheque data, go to the main menu and select Results, followed by Serotheque Export. This option allows the user to export the results of batches processed with the Triturus to other programs that accept text file format separated by commas. The program displays a window containing a list of all the Serotheques that have been processed. Select the batches that are to be exported and click on OK. Give the exported file a name. Once the data has been exported, they will be arranged in a set of fields described as follows: Id_Triturus: It displays the identification of the instrument. This identification is the one established in the Host's configuration window (see Figure 69). Date: It displays the date on which the batch was processed. Time: It displays the time at which the test was processed. Batch: It displays the batch number. Test: It displays the name of the test. Well: It displays the well number in the plate. Num_Sample: It displays the sample number, calibrator or control. Id_Sample: It displays the sample identification. Replicate: It displays the replicate number. Volume: It displays the transferred volume. Units: It displays the unit (µl). 15-3

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141 Miscellaneous operations 16 MISCELLANEOUS OPERATIONS This chapter lists all the operations that can be performed from the Misc. and Help options of the main menu. Figure 66 shows the drop-down menu corresponding to Misc. Figure 66: Misc. drop-down menu 16.1 Initialize The program sends acknowledgement and start-up commands to the Triturus. Under normal conditions, it is not necessary to carry out any initialization since this is done automatically Priming This option carries out a priming of the hydraulic circuit. The priming is very important in order to maintain correct syringe precision. The instrument automatically performs the priming operation when it is connected. It is advisable to carry out several complementary priming operations if the instrument has not been used during a prolonged period of time, during the installation or if bubbles are detected in the syringes. 16-1

142 Miscellaneous operations 16.3 Rinse This option rinses the hydraulic circuit using distilled water. The instrument automatically performs washes of the hydraulic circuit in order to prevent the build-up of precipitates that could alter the normal liquid dispensing operation Decontamination It performs a decontamination operation of the Triturus hydraulic circuit. Following the program instructions, which include the changing of the contents of a container, carries this out. See chapter 17 MAINTENANCE. In the System Warning window, a message will appear when decontamination is considered necessary. This decontamination process only has an effect on the interior of the hydraulic piping. For surface decontamination see chapter 17 MAINTENANCE Emptying of the waste container If the installation is equipped with specially designed sumps for biological waste or a container for such a purpose, a tube may be installed from the automatic emptying connection (Ref. 8, Figure 2) to the sump or container. This option may then be used to perform the emptying operation automatically Manual probe washing In order to guarantee the correct operation of the probe level detector system, and to maintain the exterior of the probes clean, the probes should be periodically manually cleaned and when it is suspected that they might be dirty. This option facilitates this operation by locating the probes in an accessible fashion. Please consult the chapter 17 MAINTENANCE Self-Test This option automatically performs a succession of tests to confirm that the different parts of the instrument work correctly. In order for this option to completely test the analyzer s modules, the following elements must be placed in their respective positions: Outside carrousel crowns: 2 predilution tubes, 2 sample tubes and two 300 µl tips. 16-2

143 Miscellaneous operations Inside carrousel crown: 3 vials with 200 µl of distilled water in positions 1, 2 and 3. Containers: At least 500 ml of distilled water, primer solution and a waste container of 1000 ml. Figure 67: Self-Test window During Self-Test execution, the program opens a window (Figure 67) with information on the status of each test: - A grey circle indicates pending tests. - An intermittent orange circle indicates tests in progress. - A green circle indicates correctly finalised tests. - A red circle with uppercase text indicates incorrectly finalised tests. A report can be printed once the Self-Test has concluded by pressing the Details button. 16-3

144 Miscellaneous operations CAUTION! If any of the tests performed during the Self-Test do not finalise correctly, contact the TECHNICAL SERVICE Technical Service The Triturus Technical Service menu may be accessed via this option. This menu is password-protected and should not be used except by an authorised QUALIFIED TECHNICIAN. The explanations for the Technical Service options are outside the scope of these Instructions for Use Password control The Triturus program manages a group of passwords that allow access to the various programming levels. There are three different programming levels: - Technical Service: This allows access to the entire program, including the Technical Service menu. - Supervisor: It permits access to the entire program except the Technical Service menu. - User: It allows access to the test results in order to validate or invalidate. This does not allow access to the tests programming nor to the Technical Service menu. Figure 68 shows the Password Control window, which is reached by selecting this option and entering the supervisor s password. There is a checkbox on the upper part of the window that enables the use of passwords. The passwords are hierarchically arranged on two levels: The one of the supervisor (high-priority) and the one of the rest of the users. The supervisor and the users are recognised through a user name, and a password. 16-4

145 Miscellaneous operations Figure 68: Password control window The name of the supervisor, which may be edited, appears at the top of screen, together with a button for changing the password. There is a list of users and their corresponding passwords on the lower part of the screen. The users passwords are displayed on this screen because the supervisor is the only person authorised to access and modify them. The New User, Modify User and Delete User buttons enable the required list to be established. There is also another button that allows any specific user on the list to be enabled or disabled Configuration This section provides information about the various program configurations and options. Figure 69 shows the configuration window, which consists of several sheets that may be selected using the upper tabs. Some of these are of a technical nature and are not explained in detail. Contact Technical Service with any questions. 16-5

146 Miscellaneous operations Figure 69: Configuration window Print This window allows configuration of reports. It is divided into two sections: Heading: Offers the option of customizing reports through text appearing at the top of the reports. (Ref. 1, Figure 30). Bottom margin: Allows blank lines at the end of each report page to be configured, in order to adapt them to the available printer. Interpretation level format: Allows configuration (style and colour) of the interpretation level text Options This permits the Triturus program language to be selected. This also allows the choice of start with the Worksheet when the Triturus program is initiated Dilutor This allows selection of different options relating to the dilutor module. Automatic sample cancelling after pipetting errors: Allows the analyzer to automatically cancel a sample after a pipetting error. 16-6

147 Miscellaneous operations Automatic test or sample cancelling 1 minute after pipetting errors: Allows the analyzer to automatically cancel a sample or a test one minute after detecting an error in pipetting the sample or reagent, respectively. Once cancelled, the analyzer will continue to process the remaining samples or tests. Activate audible alarm in case of error: In the event of error, the analyzer activates an audible alarm that can be stopped by pressing any button on the computer keyboard. When incubating always cover the plates, even at room temperature: The analyzer covers the plates for incubations higher than 25ºC. Through activation of this option, incubations under 25ºC are also performed with covered plates. Pipetting of replicates independently: This option allows selection of dependant (all from the same dilution) or independent (all from the same original sample) processing of replicates. Predilution tubes are used in all the dilutions: The analyzer, dilutes the sample without the need to use predilution tubes, according to different factors such as the type of dilution, number of replicates, tip type and volume to be dispensed into the well. By activating this option, the analyzer uses predilution tubes to dilute the sample, independent of said factors. The predilutions of all the plates are prepared at the beginning of the batch: If there is more than one plate in a batch, the analyzer carries out sample dilution and later dispensing it on the plate before processing the next plate. With this option, and if a real optimization time exists, the analyzer distributes the required diluent in the predilutions tubes for all samples of all plates in the batch, and then continues with the process normally, dispensing the first plate Host It enables the activation and selection of specific parameters in relation to the communications with a central computer (Host). The explanations for the Host options are outside the scope of these Instructions for Use Help This option allows getting access to a document with the Instructions for Use of the Triturus. 16-7

148

149 Maintenance 17 MAINTENANCE 17.1 Maintenance plan Maintenance is the set of operations that are carried out at regular intervals in order to preserve the functionality and reliability of the Triturus. There are various types of maintenance operations. Some of them are very simple and may be performed by the OPERATOR. Others, however, should only be carried out by the authorised QUALIFIED TECHNICIAN. Among the operations that can be carried out by the OPERATOR are those of checking, cleaning and decontamination of the equipment. As a general rule, and provided that there is no irregularity in the operation of the equipment, the maintenance plan that should be followed is as follows: OPERATION Check for loss of liquids ( ). Check for growth of microorganisms ( ). Cleaning of surfaces ( ). Cleaning of probes ( ). Clean the tray for disposable tips ( ). Decontamination (17.2.2). Optical system cleaning ( ). Technical Service Maintenance ( ). INTERVAL DAILY WEEKLY PERIODIC 1 month 1 month 6 months Periodical maintenance operations (greater or equal than one month) carried out by OPERATOR or by a QUALIFIED TECHNICIAN, should be recorded in the table attached at the end of this manual. 17-1

150 Maintenance 17.2 Cleaning and decontaminating equipment DANGER! During cleaning and decontamination processes, protective gloves must be used by the OPERATOR. WARNING! The cleaning and/or decontamination works of equipment surfaces shall be carried out with the equipment unplugged from the electric main supply. WARNING! Take care of not leaking cleaning/decontamination solution into the equipment openings. CAUTION! Before using any cleaning or decontamination methods except those recommended by the manufacturer, the RESPONSIBLE AUTHORITY must check with the manufacturer that the proposed method will not damage the instrument. CAUTION! Due to the fragility of the removable parts (wash manifold, carrousel, containers, container caps, tip waste tray and reagent tray), special attention must be paid during cleaning and/or decontamination processes. 17-2

151 Maintenance Equipment cleaning Loss of liquids The items to check are: - The pistons of the four syringes and the surfaces where the syringes might drip onto. If any loss is found, then the Technical Service should be notified. - The carrousel and the tray underneath the carrousel. - The reagent tray and drawer. - The probes wash area (behind the reagent drawer). - The plate wash area and the plate wash manifold. Any loss or drops of liquid must be very carefully cleaned and the Technical Service should be notified if it occurs again The growth of microorganisms The growth of microorganisms should be prevented through the systematic cleaning of the equipment. Check daily: - The containers and their caps. - The container connection fittings. - The incubator, washer and plate and cover deposit surfaces. - The washer manifold. - The carrousel, the plate-loading platform and the sampling zone. - In general, all the interior surfaces of the instrument. The Technical Service should be notified if any dirt is seen in inaccessible places Cleaning of surfaces A damp cloth should be used to clean the surfaces of the carrousel, plateloading platform, underneath the carrousel, the reagent drawer, the incubator surfaces, the washer, the washer manifold, the reader carrier and the processed plates and cover deposits. The covers and the frames should also be kept clean. In case of any liquid spill, it should be rapidly eliminated and the surface decontaminated: Dry the wet surface with absorbent paper. Use a cloth dampened with 70% alcohol to clean the surface. 17-3

152 Maintenance Leave the solution in contact with the surface for, at least, ten minutes. Rinse the surface with another cloth dampened with distilled water. DANGER! Some liquids carry a chemical or biological risk. The established regulations for working in laboratories in relation to the use of suitable gloves or clothing should be followed. DANGER! The Triturus has been designed so as to minimise the possibility of liquids entering section containing electrical devices. Nevertheless, if large quantities of liquid are spilled (in excess of 5 ml), then the equipment should be immediately disconnected from the mains supply in order to prevent any possible risk Cleaning of probes During normal operation of the equipment, incrustations could build up causing incorrect assembly of the disposable tips on the probes and resulting in an incorrect operation. Periodically, the metal shafts that hold the disposable tips, as well as the fixed needle, should be externally cleaned with 70% alcohol: Use a cloth dampened with 70% alcohol to clean the surface. Leave the solution in contact with the surface for, at least, ten minutes. Rinse the surface with another cloth dampened with distilled water. The option Manual Probe Washing that appears on the Misc. submenu of the main menu can help in this cleaning operation by placing the probes in a position that is comfortably accessible to the OPERATOR Disposable tips tray Remove the disposable tips tray. Empty it in a suitable container for contaminated material. 17-4

153 Maintenance Wet the tray with a 0.5% solution of sodium hypochlorite. Leave the sodium hypochlorite solution in contact with the tray for, at least, ten minutes. Rinse with distilled water Optical system The light meter is located underneath the surface of the incubators and has the shape of a fork in the middle of which the plate is positioned for reading. Very carefully clean the glass of the lower surface of the fork with a cloth dampened in 70% alcohol Technical service maintenance QUALIFIED TECHNICIAN trained by the manufacturer should revise sixmonthly servicing. This maintenance should include a check of the equipment s mechanical parts (adjustments and transmission, etc), the fluid section (piping, valves, dilution syringes, etc), the optics (lamp and light meter checks etc) and the computer system (disk checks, etc) Equipment decontamination In order to prevent any risk of infection, it is very important to carry out a decontamination of the instrument before performing certain operations with it. Equipment decontamination should be performed under the following situations: - The production of potentially contaminating liquid spills or leaks, etc. - Preparing the equipment for transport or storage. - Prior to certain maintenance and repair operations. - Equipment disposal. The hydraulic circuit and any surfaces that are in contact with potentially contaminating liquids should be decontaminated Surface decontamination Prepare a 0.5% solution of sodium hypochlorite. Wet the zones to be decontaminated with the prepared solution. Remove any type of incrustation. 17-5

154 Maintenance Leave the solution in contact with the contaminant parts for, at least, 15 minutes. Rinse with a cloth dampened with distilled water Hydraulic circuit decontamination Select the Decontamination option on the Misc submenu, on the main menu, and follow the program instructions. Replace the distilled water container by another identical one containing a 0.5% solution of sodium hypochlorite. Press OK to continue. The equipment will automatically carry out a priming of the entire hydraulic system and will maintain it for a period of 15 minutes. Replace the decontaminating solution container by the distilled water container. Press OK to continue. The equipment will automatically perform a rinse of the entire hydraulic system using distilled water. DANGER! The sodium hypochlorite solution is corrosive that can cause irritation to eyes and skin, it is toxic by inhalation, absorption or if swallowed. The washer manifold may be dismounted by simply pulling on it. Once it has been removed, it may then be washed and/or sterilized in an autoclave. The containers and caps can also be placed in an autoclave. To avoid any container deformations, do not place them with the caps closed. The previously described procedure does not guarantee that the equipment is totally decontaminated, but it reduces any risk of contamination to a minimum. 17-6

155 Maintenance 17.3 Information about contaminant liquids DANGER! Any part of the equipment that could come into contact with blood or serum samples, calibrators, controls or any other biological liquid should be treated as potentially contaminant. Some reagents, such as the reaction stop solutions, may be caustic. In order to prevent any risk, the following protective clothing should be worn during the decontamination process: - A long-sleeved laboratory coat with elastic cuffs. - Throwaway gloves. - Protective goggles. Special precautions should be taken when handling the following parts of the equipment: - Metal probes. - Washer manifold. - Waste container. - Disposable tips tray. - Reagent containers. - Used plates Decontaminating liquids DANGER! The sodium hypochlorite solution that is used during equipment decontamination could be harmful if it is not handled correctly. When handling these liquids: Always use a laboratory coat with long sleeves and elastic cuffs, gloves and protective goggles. Always handle them it in a well-ventilated room. 17-7

156 Maintenance In case of accidental contact with the skin or eyes, immediately wash in abundant water and seek medical attention Computer system The Triturus uses a standard PC and operating system on which the Triturus program is loaded and run. It is highly recommendable not to use this computer for other uses apart from that of the Triturus. The usual security procedures for computer systems should be employed in order to prevent any problems caused by inexperienced personnel, computer viruses, etc. The Triturus has not been designed to store historical data. For this reason, it is not supplied with tools nor procedures for back-up copies or for data recovery. In case of a computer system malfunction, the Triturus program may be reinstalled on the same or a different computer, and will be ready for use once the options indicated in these Instructions for Use have been configured. It is possible, however, that the disk data will be lost. 17-8

157 Transport and storage 18 TRANSPORT AND STORAGE WARNING! Take care of decontaminating the equipment before being transported and/or stored Equipment storage If the Triturus has to be stored for a long period of time, it is recommendable to pack it as for transportation. The required storage environmental conditions are those indicated in section 3.1 Technical specifications. The space requirements for storing the equipment are as follows: - Size: 115 cm height x 100 cm depth x 125 cm width. - Weight: 160 kg. (approximately). WARNING! Only use the original packaging for transporting the equipment Unpacking the equipment Before unpacking the Triturus, it should be located on its pallet as close as possible to where it is to be installed. In order to unpack the equipment, the packaging material should be removed by following these instructions: Remove the wooden box taking into account the screws that join it to the pallet. Remove the protective material that is wrapped around the equipment. Unscrew the supports that join the equipment to the packaging base. Screw the transport handles into the lateral holes of the equipment (where the supports were fixed). Check that the equipment is not damaged due to the storage and transport. 18-1

158 Transport and storage 18.3 Locating the equipment. Four people are required for transporting the equipment, one at each corner. One hand should be used to grip the transport handle (Figure 70), and the other should be placed on the side of the equipment to prevent any unbalance. All four people should lift the equipment together, in a synchronized way, keeping their backs erect and then place it on its corresponding shelf. Figure 70: Equipment transport handles DANGER! The weight of the equipment is quite considerable and it is therefore recommended that these instructions for location be strictly followed. It should be lifted by four people, holding it in the indicated manner (hands on the handles, back erect and flexing their legs). 18-2

159 How to dispose of the instrument 19 HOW TO DISPOSE OF THE INSTRUMENT This chapter explains how to dispose of the Triturus once it is no longer required. CAUTION! When the equipment is at the end of its useful life, you must take into account all local in force regulations to dispose of it. If the equipment is to be disposed of, it should be first completely cleaned and decontaminated and any possible remains of samples and reagents should be eliminated. Once this has been completed, the instrument should be sent to an authorised centre for the disposal of this type of waste. DANGER! This instrument should only be disassembled by authorised specialists. The Triturus is considered to be electronic waste. The local authorities can provide information about waste collection centres. 19-1

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161 Warranty 20 WARRANTY The warranty conditions are set up in documents aside. For additional information contact the equipment s supplier. The following parts are excluded from warranty: - External equipment connections. - Fluid tubes and its fittings. - Syringe. - Wash and waste solution containers. - Probes. - Disposable tip waste tray. 20-1

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163 Warnings and incidents 21 WARNINGS AND INCIDENTS During the normal operation of the Triturus, certain warnings may appear and trivial incidents might occur, which the OPERATOR is able to resolve without the need for intervention by the specialised Technical Service. The warnings will appear in the upper right text box (System Warning window) and do not require any immediate attention on the part of the OPERATOR. They are recommendations for the future. However, if they are not eventually performed, they could become incidents. On the other hand, the incidents will appear in a dialogue box with a red background indicating the cause. There are two basic types of incidents: - Automatically resolved incidents: If the OPERATOR does not resolve the problem within a specified period of time, the Triturus will automatically cancel the sample, test or plate and will continue executing any other pending work. - Non automatically resolved incidents: The OPERATOR must select the way in which the problem is to be resolved. In the automatically resolved incidents, a window appears that includes information about the incident that has occurred, a counter indicating the remaining time for resolving the incident and the Stop button. Press Stop in order to stop the countdown. Resolve the problem. Press Retry. If the countdown is not detained, when it reaches zero, the Triturus will automatically cancel the sample, test or plate and will continue with any other pending work. In the non automatically resolved incidents, a window will appear that contains information about the incident that has occurred and the Cancel, Retry and Fix manually buttons. The Cancel button allows a sample, a test or a plate to be cancelled in function of the type of incident produced. On the other hand, the Retry button will permit the process that caused the incident to be repeated. In many cases the Fix manually option appears. When the Fix manually button is pressed, the incident can be solved through the intervention of the OPERATOR. 21-1

164 Warnings and incidents Other buttons may appear in certain incidents, such as: Cancel remaining replicates when an error occurs in the reagent-dispensing process, or Changing tips in errors of disposable tip function. Through the Misc, Configuration and Dilutor menus, pipetting incidents that are automatically resolved can be enabled or disabled (Refs.1 and 2, Figure 71). Figure 71: Configuration dilutor window 21.1 Messages in the System Warning window The warnings that appear in the upper right text box are listed below: Unable to communicate with the Triturus. Is it switched on and connected to the PC? The program cannot communicate with the Triturus. Check that the Triturus is connected to the mains supply and switched on. Check that the Triturus serial cable is not damaged or incorrectly connected (wrong communications port). 21-2

165 Warnings and incidents Once the incident has been resolved, the equipment will automatically connect itself. If it cannot be resolved, then notify the Technical Service Communication port unavailable. Try to free the port Another system program is occupying the communications port. Check that there are not two Triturus applications being run at the same time and which use the same communications port (windows status bar). Close any application that is using the same communications port as the Triturus Disposed tips tray full. Please empty It has been detected that the disposable tips tray is full and it is recommended to empty it. Once emptied, double-click on the warning message to make it disappear The lamp of the reader should be changed as soon as possible Based on the hours of lamp use, it is recommended that it be changed. Get in touch with the Technical Service Wait, the reagent drawer will open soon After an OPERATOR request to open the reagent drawer, the Triturus will decide when it can be opened depending on the task that is being executed Wait, the carrousel door will open soon After an OPERATOR request to open the carrousel door, the Triturus will decide when it can be opened depending on the task that is being executed The processed plates deposit is completely full. Please remove plates The Triturus has detected that processed plates deposit is completely full, and cannot continue with the normal execution of the batch. Open the main door. Empty the plate deposit. Close the main door Initialising is cancelled. Perform initialising manually The Triturus has not been able to initialise itself correctly. Get in touch with the Technical Service. 21-3

166 Warnings and incidents This sample has automatically been cancelled The Triturus was unable to detect sufficient sample or diluent, and since the automatic cancelling option is enabled, the sample has been cancelled Plate number XX has no wells A plate without wells is being programmed Exceeding maximum number of 4 plates per batch A batch is being programmed that exceeds the capacity of the Triturus A batch cannot contain more than 120 disposable sample tips A batch is being programmed that exceeds the capacity of the Triturus and Prepare dilution of all plates at start of batch option is selected through the Misc., Configuration and Dilutor menu Exceeding maximum number of predilution tubes A batch is being programmed that exceeds the capacity of the Triturus XX container wrongly placed The Triturus has detected that the indicated container is incorrectly positioned or is missing Fill XX container The Triturus has detected that the indicated container has not enough level to finish the bath Empty waste container The Triturus has detected that the waste container has not enough capacity for the waste liquids that will be generated during the batch running Liquid has been detected in the washer platform during XX washing of Plate YY in Batch ZZ Triturus has detected liquid in the washer platform. If the plate has been handled during the process, check that its position has not been inverted. If this error is ruled out, check that the test programming cannot lead to overflowing. If it is not possible that either of these errors are the cause of the overflow and the problem persists, please contact the Technical Service. 21-4

167 Warnings and incidents 21.2 Incidents in batch verification The warnings that appear after instrument verification, before initiating a work batch, are listed below: You have put more samples in the carrousel than selected on the Worksheet The Triturus has detected a difference between the programmed samples and the samples detected on the carrousel. If Ignore is pressed, the program initiates the work batch by processing only the samples selected on the Worksheet XX more disposable tips are required in the carrousel During verification, missing tips have been detected. Open the door of the carrousel. Add the number of tips indicated by the program. Close the door of the carrousel. Reinitiate the batch. If Ignore is pressed, the program initiates the batch, stopping when the tips in the carrousel have been spent. The error message of section Tips are required in the carrousel or in the reagent tray is then shown. The program reinitiates the process once tips have been added XX more predilution tubes are required in the carrousel During verification of new batch, missing predilution tubes have been detected. Open the door of the carrousel. Add the number of tubes indicated by the program. Close the door of the carrousel. Reinitiate the batch. If Ignore is pressed, the program initiates the work batch. As soon as the predilution tubes are needed to perform the dilutions, the analyzer halts and displays the error message from section Predilution tubes are required. 21-5

168 Warnings and incidents Sample(s) XX not placed in the carrousel The Triturus has detected that the carrousel does not contain all of the samples programmed on the Work Sheet. Open the door of the carrousel. Add the programmed samples to the Worksheet. Close the door of the carrousel. Reinitiate the batch. If Ignore is pressed, the program initiates the batch, establishing that a sample tube is actually in place in the positions where sample tubes have not been detected. CAUTION! Press Ignore only after confirming that the samples not detected are in the carrousel but the instrument has not detected them Wrong number of plates on the plate-loading platform The Triturus has detected that the number of plates on the plate-loading platform is not the number requested on the Reagent Layout Sheet. Open the door of the carrousel. Place the plates as indicated in the Reagent Layout Sheet. Close the door of the carrousel. Reinitiate the batch. The Ignore option does not exist in the verification of the number of plates Well number XX not found in the plate During detection of the plate wells, the Triturus has not detected all the wells requested on the Reagent Layout Sheet. Open the door of the carrousel. Place the number of wells on the plates as indicated in the Reagent Layout Sheet. Close the door of the carrousel. Reinitiate the batch. 21-6

169 Warnings and incidents If Ignore is pressed, the program initiates the batch establishing that a well is actually in place in the positions where no well has been detected. CAUTION! Press Ignore only after confirming that the wells not detected are in the plate but the instrument has not detected them Complete the last strip of each test with wells in order avoid liquids spilling during the wash process. During detection of the wells on the plate, the Triturus has detected that the last strips of wells in each test have not been completed. Open the carrousel door. Complete the last strips, of each test, on the plate that the programme identifies using wells identical to those used in the respective test but which may have been used previously. Close the carrousel door. Restart the batch. If Ignore is pressed, the programme starts the batch establishing that there truly is a well placed in the positions where it indicated there were none. CAUTION! Press Ignore only after verifying that the wells not detected are indeed on the placed, but the instrument has failed to detect them Verify liquid level in containers One or more solution containers do not have sufficient volume for processing the work batch programmed. Open the access cover of the containers. Fill the containers indicated with the necessary volume. Close the access cover of the containers. Reinitiate the batch. 21-7

170 Warnings and incidents If Ignore is pressed, the batch is initiated. When the level of the containers is below minimum processing level, the process halts and an error message of section Liquid level error in container appears Incidents in the execution of a batch The messages shown in the program when incidents are detected during the execution of batches are listed below: Error in the containers connections The tubes of the indicated container are not correctly connected. Open the access cover of the containers. Check that all tubes are connected as indicated in the connection diagram which is inside the access cover to containers (Ref. 12, Figure 1). Press Retry. The instrument performs the check again. Close the access cover of the containers. If the connections have been found to be correct and Retry has been pressed, but the program still shows the same message, Ignore can be pressed to continue the batch. 21-8

171 Warnings and incidents XX container wrongly placed The indicated container is not fully in place and the container level system does not detect it. Open the access cover of the containers. Push the indicated container toward the inside of the instrument until the mark on the base is completely visible. Close the access cover of the containers and press Retry Liquid level error in container The indicated container has a volume below minimum processing level Open the access cover of the containers. Remove the container and add the necessary minimum volume. Press Retry. Close the access cover of the containers. If it is a waste container, the process also halts when a full container is detected. 21-9

172 Warnings and incidents Open the access cover of the containers. Remove the container and empty it. Press Retry. Close the access cover of the containers. If the waste disposal connection of the instrument is connected to a drain or external waste container, the waste container can be emptied automatically: Press Emptying of the waste container. Once emptied, press Retry Not enough pressure or vacuum The instrument does not reach the necessary pressure or vacuum to work correctly. Open the access cover of the containers

173 Warnings and incidents Check that rubber seals are present on the caps of solution containers, the adequate closure and the correct placement of fittings on the different tubes. Press Retry to continue The Triturus has stopped momentarily The Triturus has stopped execution at the request of the OPERATOR The Triturus is processing tests The OPERATOR has pressed Close Application during the execution of the batches

174 Warnings and incidents There is no carrousel installed The Triturus does not detect any carrousel installed. Open the door of the carrousel. Place the carrousel ensuring that it is correctly seated on the centring mechanism of the carrier system. Close the door of the carrousel and press Retry. If the carrousel is present and the program shows this message, the carrousel is not correctly seated on the centring mechanism of the carrier system. Open the door of the carrousel. Turn the carrousel slightly until it is seated on the centring mechanism of the carrier system. Close the door of the carrousel and press Retry Carrousel door open 21-12

175 Warnings and incidents Close the door of the carrousel correctly. If this takes place during a process, the Triturus automatically continues the pending task Can not open the carrousel door The Triturus cannot open the door of the carrousel. You may be trying to open the door by hand while requesting opening with the carrousel door button. Do not hold the door. Press the carrousel door button again. Press OK General door open Close the general door of the instrument correctly. If this takes place during a process, the Triturus automatically continues the pending task

176 Warnings and incidents Reagent drawer open Close the reagent drawer correctly. If this takes place during a process, the Triturus automatically continues the pending task Can not open the reagent drawer The Triturus cannot open the reagent drawer. You may be trying to open the drawer by hand while requesting opening with the reagent drawer button. Do not hold the drawer. Press the reagent drawer button again. Press OK

177 Warnings and incidents Please, lower the plate-loading platform Open the door of the carrousel. Place the plate-loading platform in a horizontal position. Close the door of the carrousel Level error The level error window opens when the probes detect no fluid. Open the door of the carrousel or the reagent drawer. Add the necessary minimum volume of the indicated sample or reagent. Close the door of the carrousel/reagent drawer. Press Retry to continue. If the Triturus is using disposable tips to dispense diluent or reagents, the option Changing tips will appear in the error window. Tip defects can cause this type of error. This option allows the program to discard the tip causing the problem and it will retry detection with a new tip. The Fix manually option can be pressed

178 Warnings and incidents Fix manually in samples: Open the door of the carrousel and check that the minimum volume for aspiration exists. Close the door and press Fix manually. The following screen will appear: Use the cursors to lower the probes until they touch the fluid, or position the probes directly in the bottom of the tube by pressing Bottom of the tube. Press OK. A warning window will open to report that the wells diluted in this way will appear marked in the result window and should be validated individually

179 Warnings and incidents Fix manually in reagents: After pressing Fix manually, the wells in which manual dispensing of reagent should be performed are listed. Press OK. The wells involved will appear marked in the result window and the OPERATOR should validate them individually

180 Warnings and incidents Insufficient level The Triturus detects the liquid level but the existing volume is not sufficient for performing the process. The steps to follow in order to continue the test are the same as in the above case Clot error This may be due to obstruction of the probe by a clot or by aspiration of any solid residue. If the test that is processing uses disposable tips, press Retry. The instrument finalises the process with an unclogged tip. It then expels the two tips and picks up a new tip with the probe that gave a clot indication, in order to retry the process

181 Warnings and incidents If the test that is processing uses a fixed needle, press Fix manually. The probes position themselves for manual washing of the probes. Insert a wire in the end of the fixed needle to remove the obstruction. Press Retry to continue with the process Tips not found The probes have not detected tips in a certain position. Open the door of the carrousel. Place tips in the empty positions of the carrousel. Close the door of the carrousel. Press Retry to continue. If Ignore is pressed, the program continues the process by establishing that the probes really have disposable tips. CAUTION! Press Ignore only if it is confirmed, after opening the door of the carrousel, that the probes have picked up disposable tips but the instrument has not detected them

182 Warnings and incidents Tips are required in the carrousel or in the reagent tray The Triturus needs more disposable tips in the carrousel or in the reagent tray to continue execution of the batches. Open the door of the carrousel or reagent drawer. Place the necessary tips. Close the door of the carrousel or the reagent drawer. Press OK Predilution tubes are required The Triturus needs more predilution tubes to continue execution of the batches. Open the door of the carrousel. Place the necessary tubes

183 Warnings and incidents Close the door of the carrousel. Press OK The processed plates deposit is full The program reports that the processed plates deposit is completely full. The pending job is not cancelled by this incidence, however, the equipment halts until the OPERATOR empties the station. Open the general door. Empty the processed plates deposit. Close the general door. Press OK to continue Plate not found 21-21

184 Warnings and incidents The Triturus has not detected the plate in the indicated position. The plate may have been removed for inspection and not replaced in the correct position. Open the general door. Place the plate in the position indicated in the message. Close de general door and press Retry. If the plate is in its place but the Triturus does not detect it, solve the incident using the Fix manually option. Press Fix manually. Open the carrousel door/general door. Manually place the plate in the position indicated in the graph. Close the carrousel door/general door. Press OK to continue