Page 1 CHORUS OPERATING MANUAL Release Software N° 2.09 rev 30 Multiparametric processor for immunometric assays with ready to use single test devices.
Page 2 For the USA DIESSE INC. 1690 W 38 Place, Unit B1 Hialeah, FL 33012, U.S.A. Phone: (305) 827-5761 | 1-877-DIESSE-3 | Fax: (305) 827-5762 E-Mail : salesoffice@diesse.us SERVICE ASSISTANCE DIESSE INC. 1690 W 38 Place, Unit B1 Hialeah, FL 33012, U.S.A.
Page 3 Printed in 2012 (Total pages: 127) ATTENTION Don’t use this manual if it is not complete. If this manual is used when not complete, DIESSE Diagnostica Senese S.p.A. declines responsibility for any adverse results. To request a new copy contact Servizio Customer Care - Via del Pozzo 5, 53035 Monteriggioni (SI), Italy. Tel. ++39 0577 319556 Fax.
Page 4 The CHORUS instrument is designed to be used exclusively with established DIESSE procedures which are stored in the instrument memory. The CHORUS instrument is designed to be used with components manufactured and supplied by DIESSE (strips, diluent solution, washing solution etc.).
Page 5: Table Of Contents
CHORUS Manuale operativo TABLE of CONTENTS INTRODUCTION ........................ 9 SAFETY INFORMATION ......................9 FIELD OF APPLICATION ......................9 1.2.1 Infectious diseases ......................9 1.2.2 Autoimmunity ........................9 DESCRIPTION OF THE INSTRUMENT ................10 1.3.1 Front side ........................11 1.3.1.1 Introduction of the strips ......................11 1.3.1.2...
Page 6 CHORUS Manuale operativo 3.2.6 Electrical connections ..................... 29 SWITCHING THE INSTRUMENT ON ..................30 START-UP CONTROLS ......................31 3.4.1 Electronic check ......................31 3.4.2 Calibration of the touch-screen ..................31 3.4.3 Control of the lid ......................31 3.4.4 Control of the motors ...................... 32 3.4.5...
Page 7 Identification of the Buffer Solution for Autoimmunity ............ 116 : ............................. 117 N CASE THE IDENTIFICATION OF ONE OF THE TWO TANKS OF BUFFER IS SKIPPED THE INSTRUMENT SETS ........................117 THE IDENTIFIED BUFFER CHORUS HOSTING ......................118 5.6.1 Introduction ........................118 Rev. 0 del 06/2012...
Page 8 CHORUS Manuale operativo 5.6.2 Communication Protocol ....................118 5.6.3 Interface Programming ....................119 5.6.4 Serial communication frame ..................120 5.6.5 Enquiry ......................... 120 5.6.6 Sample programming ....................121 5.6.7 Result management ..................... 123 EC DECLARATION OF CONFORMITY ................126 Rev. 0 del 06/2012...
Page 9: Introduction
FIELD OF APPLICATION The CHORUS instrument is a multi parametric instrument, designed to automatically conduct serologic tests using ready to use diagnostic devices with single doses (strips). The available test panels are: Infectious diseases and Autoimmunity.
Page 10: Description Of The Instrument
Manuale operativo DESCRIPTION OF THE INSTRUMENT The CHORUS instrument is a main “bench-top” type unit, completely autonomous, operating with its installed software already programmed to conduct the necessary tests (see fig. 1). The high level of automation characterizes it as a real instrument with “walkaway” potentiality.
Page 11: Front Side
CHORUS Manuale operativo 1.3.1 RONT SIDE 1.3.1.1 Introduction of the strips By lifting the cover with the green port-hole positioned on the left front side of the instrument (A) fig. 1, it is possible to access the zone to insert strips into the tray (see fig. 2).
Page 12: Back Side
1.3.2.2 Hydraulic connections The hydraulic section area is located on the back of the instrument on the right side as described in figure 6. 1. identification code of the CHORUS product 2. manufacturing date 3. serial number of the instrument 4.
Page 13: Supplied Materials
CHORUS Manuale operativo SUPPLIED MATERIALS The instrument is delivered in a box including: • n°1 CHORUS instrument with the software installed • n°1 bar code reader with cable • n°1 separate power cable • n°1 10x concentrated Washing Buffer solution •...
Page 14: Environment Requirements
CHORUS Manuale operativo • Sensor LCD solid state (2048 pix) • Default codes code 128, code 39, Interleaved & Codebar 2 of 5 • Test tube codes 1-16 alphanumeric characters • Strip and bottle codes 1-20 alphanumeric characters Communication ports •...
Page 15: Safety
CHORUS Manuale operativo 2 SAFETY MECHANICAL RISKS 2.1.1 RANSPORTATION The instrument is packaged and the internal mobile parts are blocked to guarantee safe transportation if the following precautions are taken: The package, which can be loaded on a pallet, must be moved using a transpallet.
Page 16: Movement Of The Sample Tray
CHORUS Manuale operativo 2.1.4 OVEMENT OF THE SAMPLE TRAY The only part of the moving instrument which might come in contact with the operator is the strip tray (carousel), which partially extends outside the front opening. To reduce this risk the instrument is fitted with a frontal lid that has to be kept closed during the tray movement.
Page 17: Risks Due To High Temperatures
CHORUS Manuale operativo - do not over-fill the tanks when they are inserted in the instrument. - do not spill any liquids on the instrument. RISKS DUE TO HIGH TEMPERATURES The carousel is an exposed part of the instrument and is heated to a temperature that can vary from 25 to 40 °C during the test cycle, depending on the executed test.
Page 18: Personal Protection Equipment (Ppe)
- protection glasses; - lab coat. SECURITY LABELS The following labels are used on the Chorus to point out possible danger conditions. Risk of puncture to hands and fingers Risk of hands bumping mechanical equipment Risk of thermal shock at touch Risk of electrical shock at touch Rev.
Page 19: Plate Data
CHORUS Manuale operativo 2.7.1 LATE DATA manufacturer information instrument name and code (P/N) certification mark for conformity to CSA normative for Canada and USA certification mark for conformity to CE normative for European Union mark of declaration of use for in-vitro diagnostic instruments...
Page 20: Preparation Of The Instrument
This chapter includes unpacking instructions and is inserted on the external cover of the transport box. It has to be carefully read and the operations described are to be executed by specialized personnel of DIESSE Diagnostica Senese SpA or personnel authorized by DIESSE. HANDLING 3.1.1...
Page 21 CHORUS Manuale operativo The open box appears as showed in the figure fig.8 Remove the strip of wood blocking the polyethylene packing, indicated in the figure. fig. 9 To do this unscrew the two screws blocking the strip of wood, positioned on the right and left side of the box.
Page 22 At this point the ply-wood box can be taken down, unscrewing the four screws positioned low on the four sides on the bottom. fig.12 Once the CHORUS instrument has been taken out of the box, it can be positioned on the working table. fig. 13 ATTENTION The operation has to be performed by two persons, using both hands.
Page 23 CHORUS Manuale operativo Before turning on the instrument, it is necessary to remove the internal protections blocking the mechanical movements of the washers, of the X trolley and of the dispensers. For this purpose, remove the superior part of the...
Page 24: Disconnection And Reinstallation
- move the tanks by themselves, using all the necessary precautions, especially for the waste tank which could drop potentially infectious liquids. Once the CHORUS instrument has been placed in its new position it is necessary to: - reconnect the waste tubes, using all the necessary precautions;...
Page 25: Installation
3.2.1 UP OPERATIONS BY THE USER The CHORUS has to be installed in an environment suitable for its normal function, that will meet the electrical requirements (see par. 1.5.2) and safety information (see chap. 2) supplied in this manual. In particular, the laboratory must have a network socket in accordance with relative legislation, fitted with a correct earth connection and with a line voltage that must be guaranteed in accordance with the power and frequency specifications.
Page 26: Washing Buffers
CHORUS Manuale operativo Each of the probes that must be inserted into the tanks (see fig. 17), is equipped with two terminals: - a plastic tube with relative connector, for aspiration of the liquid, identified by a blue (Infectious Washing buffer), green (Autoimmunity Washing buffer) or white band (Cleaning...
Page 27: Sanitation Solution
CHORUS Manuale operativo - insert the probe connected to the CLEANING (white) entrance 3.2.2.3 Sanitation solution The Sanitation Solutions is used as a substitute to the Cleaning Solution, during the sanitation cycle. The solution is collected in a tank with code 53541 and is identified by the color yellow.
Page 28: Connection To A Centralized Waste Disposal System
In this case, only the connection with the red band can be used to connect to the drainage. If a suitable connection is required, it can be ordered from DIESSE Diagnostica Senese SpA, specifying the features of the connection needed.
Page 29: Strip Introduction
CHORUS Manuale operativo fig. 20 fig. 21 3.2.5 TRIP INTRODUCTION This operation is not strictly connected to switching on the instrument, except for the fact that during the phase of the initial automatic check (chap. 3.4), the operator is asked to insert a strip. When the front cover is opened, the inside appears as shown in fig.
Page 30: Switching The Instrument On
- Connect the network cable on one side to the power outlet located on the backside of the Chorus (see fig. 5) and the other on the available network outlet. - Move the on-off switch and bring it to the on position: the indicator “I” protruding, while the indicator “O”...
Page 31: Start-Up Controls
This is performed on request by the user, by pressing the touch screen within 5 seconds from the moment in which, right after the screen of the initial electronic check, the blue side bar and the DIESSE logo are shown (for a complete handling see 5.2).
Page 32: Control Of The Motors
CHORUS Manuale operativo No further controls will be performed on the lid. An error message (warning) will appear in the first error window, at the end of the check. If the window should close due to time-up, the system check will proceed.
Page 33: Preparations For The Check Procedure
CHORUS Manuale operativo Note: The operator has the possibility of not performing the control procedures in as far as: - the efficiency of the hydraulic circuit, - the control of the liquid present in the wash buffer circuit, - the efficiency of the optic group,...
Page 34 CHORUS Manuale operativo For verification of point D) a window (fig. 24) select the washing buffer intended for use during the working session. fig. 24 For verification of points A), B) and E), a window (see fig. 25) requests to insert and/or remove the strips from the positions indicated.
Page 35 CHORUS Manuale operativo The check continues, and the system controls the position of the strips and, if insertion/removal of the strips is not correct, the window is displayed again for a new attempt. If after the sixth insertion/removal operation of the strips the check is not executed correctly, the procedure is aborted.
Page 36: Start Of The Check
CHORUS Manuale operativo 3.4.5.2 Start of the Check 1) The Hydraulic check requires the Cleaning solution tank to contain at least 25% of liquid and consists of the following: Control of the level of liquid present in the Cleaning solution tank.
Page 37: Warm-Up
CHORUS Manuale operativo fig. 28 Note: In this case, before performing a new cycle the instrument automatically performs a quick priming of the washers Note: If there are any outstanding controls, the status bar will show the information “Not ready”. The check window (see 4.11) can be used to view the elements that need an efficiency check.
Page 38: Connection To A Host-Computer
ONNECTION TO A HOST COMPUTER The CHORUS is equipped with an RS232 serial interface, which provides a connection to a Host Computer. This connection allows the instrument to be programmed and allows the results to be handled by a centralized system.
Page 39: Strips, Calibrators And Qc
CHORUS Manuale operativo STRIPS, CALIBRATORS AND QC 3.5.1 TRIP 3.5.1.1 Label indications Each strip is identified by a barcode of 16 characters divided in 7 fields: [ AAA ] B [ CC ] D [ EE ] [ FFF ] [GGGG]...
Page 40: Serum Distribution
CHORUS Manuale operativo The insertion of the strip ensures that the strip is be pushed to overcome the resistance of the spring which, although it seems negligible, can take the operator by surprise and provoke a kick which causes the collected serum to spill.
Page 41: Label Indications
CHORUS Manuale operativo The strips with the calibrators may be processed at the same time as the sample strips of the same batches. The only condition to comply with is that the strips of the calibrators must be placed in the first positions of the trays, one by one, without any precise sequence.
Page 42: Maintenance
CHORUS Manuale operativo MAINTENANCE 3.6.1 LEANING THE INSTRUMENT AND ITS SURROUNDINGS The outside of the instrument must be cleaned using the following precautions: - switch off and unplug the instrument; - use a damp cloth (alcohol or non corrosive detergents) for the painted parts;...
Page 43: Replacement Of The Waste Tank
DIESSE Diagnostica Senese. The goal of this procedure is to prevent mold growing in the hydraulic circuit and has to be executed once a week.
Page 44: Ordinary Maintenance
CHORUS Manuale operativo Note: The execution of the sanitation causes the activation of the pendings of the priming. ATTENTION The correct maintenance of the hydraulic circuit is essential for a valid interpretation of the results of the tests executed by the instrument.
Page 45: Programmed Maintenance
CHORUS Manuale operativo 3.6.6 ROGRAMMED MAINTENANCE To guarantee correct instrument function, periodic maintenance must be programmed. This includes: - Cleaning internal parts, - Replacing worn components, - Calibrating controls, and must be performed by trained staff. The timing of these interventions must be programmed with the Technical Assistance service based on actual use of the instrument, i.e.
Page 46: Use Of The Instrument
Job List (J-list) is the list which associates all the sample codes to the test codes. In the CHORUS system the sample must be transferred to a ready-to-use device for a specific test, in order to be tested: the strip.
Page 47: Connection To Host Computer Not Available
CHORUS Manuale operativo 4.1.3.1 Connection to Host Computer not available The following procedure is recommended: • On the basis of the paper J-list, assemble the strips necessary to perform the tests. • Place all the strips in the tray (it is not necessary to respect the order of insertion from the paper J-list), taking care to place the calibrators always in the first positions of the tray.
Page 48: Description Of The Windows
This shows the company logo, the name of the instrument, current time and date. Status bar: This shows information on the status of the instrument. The white background shows that the CHORUS instrument is ready and/or running, the red, yellow, or magenta color indicates a problem interfering with normal operation, while the blue color denotes the editing mode.
Page 49: Main Window (Start Window)
CHORUS Manuale operativo MAIN WINDOW (START WINDOW) The start window appears at the end of the initial controls, and it is possible to go from this window to all the different functions of the instrument. There is no Exit key.
Page 50: Manual Editing
CHORUS Manuale operativo MANUAL EDITING Manual editing substituted the barcode reader in the following cases: - manual introduction of codes which the barcode reader is unable to read - correction of erroneous codes - introduction of personalized codes - introduction of telephone numbers for remote assistance 4.4.1...
Page 51: Editing In Insert Mode
CHORUS Manuale operativo In the starting window, the editing command can be activated in two different ways: - insert mode (default mode) - modify mode When the operator enters the screen in insert mode, the editing bar is empty and ready for the new code to be inserted.
Page 52: Editing In Modify Mode
CHORUS Manuale operativo 4.4.3 DITING IN MODIFY MODE When the operator enters the modify mode of editing, the bar shows the whole code selected, with the cursor positioned after the last character. fig. 35 The characters to be modified are cancelled by pressing the BS (backspace) key.
Page 53: The C-List Window (Coupling List)
CHORUS Manuale operativo THE C-LIST WINDOW (COUPLING LIST) The C-list shows the list of the associations between samples and tests (see 4.1) . Test/Sample: to move the selection bar from the samples column to the test column Keyb: to access the editing window...
Page 54: How To Use The C-List
CHORUS Manuale operativo 4.5.1 OW TO USE THE When the C-list window opens, there may be two possible situations: First case: list empty Second case: list compiled fig. 39 fig. 40 ATTENTION It is not possible to start the compilation of a C-list unless at least one sample code has been inserted, because each test must be associated to a sample code already present.
Page 55: Insertion Of The First Sample Code
CHORUS Manuale operativo 4.5.1.1 Insertion of the first sample code ATTENTION The Insertion mode must be enabled. INSERTION BY MEANS OF THE BAR CODE READER In an empty C-list, the selection bar is not present, and only the Keyb and Exit keys are enabled.
Page 56 CHORUS Manuale operativo INSERTION THROUGH MANUAL EDITING In an empty C-list the selection bar is not present and the only keys enabled are the Keyb and Exit keys. To insert the first sample code using manual editing, press the Keyb.
Page 57: Insertion Of The Following Sample Codes
The Insertion mode must be enabled. Note: As the CHORUS automatically recognizes the strip codes, the QC codes (quality control) and the calibrator codes, the selection bar may be positioned indifferently either on the “samples” column or on the “test” column.
Page 58 CHORUS Manuale operativo INSERTION OF A SAMPLE CODE WITH MANUAL EDITING To insert a new sample code manually, press the Keyb key (in the insertion mode, the position of the selection bar is not important). fig. 48 Insert the code manually in the editing window.
Page 59: Modification Of A Sample Code
CHORUS Manuale operativo 4.5.1.3 Modification of a sample code ATTENTION The Modification mode must be enabled. MODIFICATION USING THE BAR CODE READER The selection bar must be positioned on the line relative to the sample code to be modified fig. 51...
Page 60 CHORUS Manuale operativo MODIFICATION THROUGH MANUAL EDITING The selection bar must be positioned on the line relative to the sample code to be modified. fig. 54 By pressing the MOD key, the Modification mode is enabled: The selection bar moves to the samples column, the change column key is enabled and the status bar will show “Modify”.
Page 61: Insertion Of A Strip Code
ATTENTION The Insertion mode must be enabled. Note: As the CHORUS automatically recognizes the strip codes, the QC codes (quality control) and the calibrator codes, the selection bar can be positioned either on the “sample” column or the “test” column.
Page 62 CHORUS Manuale operativo INSERTION USING THE BARCODE READER Test not present In case the test is not present in the line selected and a valid strip code is scanned: fig. 58 The new code is inserted in the selected field.
Page 63 CHORUS Manuale operativo Test already present In case the test is already present in the line selected and a valid strip code is scanned: fig. 60 The sample code is duplicated. The new sample/test association is inserted at the bottom of the list of codes already present.
Page 64 CHORUS Manuale operativo INSERTION THROUGH MANUAL EDITING ATTENTION The Insertion mode must be enabled. Bar positioned on empty test code When the selection bar is positioned on a line without a test code, and the operator wants to insert a test manually: Press the Keyb key.
Page 65 CHORUS Manuale operativo Bar positioned on a test code which is present When the selection bar is positioned on a line which already contains the test code and the operator wants to manually insert a new test associated to the same sample code: Press the Keyb key.
Page 66 CHORUS Manuale operativo INSERTION OF STRIP CODES IN THE HOST MODE Open the C-list window. In the example shown in the figure the C-list is completely empty, but some associations could also be present (associations already present will not be considered by the connection to the Host).
Page 67: Modification Of A Strip Code
CHORUS Manuale operativo ATTENTION It is advised not to cancel the tests from the Job List because at the end of the RUN, the system automatically cancels those which have been performed, leaving only those still to be executed on the list.
Page 68 CHORUS Manuale operativo Scanning the new code leads to immediate replacement of the previous one. fig. 73 MODIFICATION THROUGH MANUAL EDITING The selection bar must be positioned on the line relative to the strip code to be changed. fig. 74...
Page 69: Cancellation Of Codes Present In The C-List
CHORUS Manuale operativo Insert the code manually in the editing window To save and exit, press the OK key (to exit without saving, press Cancel) fig. 76 The new code replaces the old one. fig. 77 4.5.1.6 Cancellation of codes present in the C-list...
Page 70 CHORUS Manuale operativo A window will appear for 10 seconds, giving the following choices: • Delete the whole C-list which is saved (All key) • Delete the single line selected by the selection bar (Current key) If the Cancel key is pressed, no changes will be made to the C-list.
Page 71: The R-List (Running List) Window
CHORUS Manuale operativo THE R-LIST (RUNNING LIST) WINDOW 4.6.1 TANDARD USE OF THE LIST The R-list contains the list of tests to be performed and may also contain the sample codes associated to these tests. (For information regarding the R-list, see paragraph 4.1.3).
Page 72 CHORUS Manuale operativo After this the R-list window will open, and may appear as follows: First case: C-list stored Second case: C-list not stored fig. 80 fig. 81 Note: If the previous cycle was interrupted, before entering this window, the instrument will automatically execute a quick priming of the washers.
Page 73: A C-List Is Stored
CHORUS Manuale operativo 4.6.2 A C- LIST IS STORED If a C-list is stored, the positions in the carousel in which valid strip codes have been identified, are associated with the sample codes present in the C-list itself. The number in blue indicates that the sample is pediatric. (This characteristic is not used at the moment, see 4.4.1)
Page 74: No C-List Is Stored
CHORUS Manuale operativo 4.6.3 LIST IS STORED If there is no C-list, the instrument simply indicates the strip codes detected in each of the 30 positions on the carousel and assigns a sample code corresponding to the position of the strip on the plate to each one.
Page 75: Insertion Of A Strip Code
CHORUS Manuale operativo If it is necessary to modify or cancel a sample code which is already associated to a test, exit from the R-list window temporarily, go to the C-list, modify the code and return to the R-list. Note: To program a pediatric sample, position the selection bar on the corresponding field, enter the editing mode (Keyb), press the Ped key and save.
Page 76: Starting The Run
CHORUS Manuale operativo STARTING THE RUN At the end of the identification phase, press the Run key to start the cycle. If any strips give an error, a message will appear asking for confirmation to start the cycle. Whenever expired strips are present on the tray, a message box will display to indicate whether they have to be processed in the cycle as well.
Page 77: Running The Cycle
CHORUS Manuale operativo RUNNING THE CYCLE 4.8.1 HE CYCLE WINDOW When the cycle starts, the system performs the tests programmed and the Run window appears. STOP: interrupts the cycle Sample in error Pag: moves between pages, showing 10 samples on each page fig.
Page 78: Cycle Results
CHORUS Manuale operativo The possible codes of the operations being performed on the samples are the following: Transfer W1 W2 W3: Washings in the three stations R1 R2 R3: Optic readings in the three stations For the error codes, see Errore. L'origine riferimento non è stata trovata..
Page 79: Printed Report
The pediatric codes are shown in blue. (This characteristic is not used at the moment, see 4.4.1) 4.8.3 RINTED REPORT Below is an example of the printout of the analysis results: CHORUS DIESSE Diagnostica Senese SpA 2006/11/01 12:00 Rel. 2.09r21 Meth. 11 S/N: 1000/10/2006 Nr Smp Code...
Page 80 CHORUS Manuale operativo Value: Numeric result. In the QC (quality control) out side the acceptability range this information is proceeded by the character !? Units of measure (varies according to the test method used) Min: Minimum acceptable limit in the case of QC (quality control)
Page 81: The Sessions Archive
CHORUS Manuale operativo THE SESSIONS ARCHIVE 4.9.1 HE ARCHIVES WINDOW This window presents a list of the runs performed, displaying the date and time of execution for each one. The instrument can store up to 20 runs; the most recent ones overwrite the oldest ones.
Page 82 Release firmware of the CHORUS Modem Release: Release firmware of the modem S/N: Serial number of the CHORUS instrument (serial number/month of production/year of production) Absolute strips: Absolute counter of the strips processed by the instrument Relative strips: Relative counter of the strips processed (returns to zero after an intervention by technical staff)
Page 83: Settings Window
CHORUS Manuale operativo 4.10.1 S ETTINGS WINDOW This window makes it possible to reach the instrument settings windows. Clock: sets the date and time of the instrument Audio: sets the volume of the speaker Contrast: sets the contrast of the monitor...
Page 84: Audio Setting
CHORUS Manuale operativo 4.10.1.2 Audio setting Store: memorizes the volume that has been set Indicator of volume (only enabled in case of modification) level increases/decreases the volume by one unit at a time Fast: if activated, allows increases/decreases by ten units at a time Exit: returns to the settings window fig.
Page 85: Remote Connection Window
Exit: returns to the utilities window fig. 99 ATTENTION This characteristic is available only on the domestic market of DIESSE or in those countries where DIESSE has verified the reliability of the data transmission via modem. Rev. 0 del 06/2012...
Page 86: Check Window
CHORUS Manuale operativo 4.11 CHECK WINDOW The check window shows the state of the instrument and allows access to the various controls necessary to re-establish good functioning. Restore: checks which controls are due to be performed and starts those necessary...
Page 87: Information On The State Of The Instrument
CHORUS Manuale operativo 4.11.1 I NFORMATION ON THE STATE OF THE INSTRUMENT Strip temp: Temperature measured inside the thermostatic chamber Instrument temp.: Temperature measured inside the instrument Wash. buf. level (infectivity or autoimmunity)/ Clean. sol. level: Level of liquid in the buffer/cleaning solution tanks.
Page 88: Errors Window
CHORUS Manuale operativo 4.12 ERRORS WINDOW If errors are found during the initial check procedure, the following summary appears: Print: prints the list of errors found with numeric identification and corresponding string Silence: disables the sound alarm Report: prints errors...
Page 89: Appendixes
CHORUS Manuale operativo 5 APPENDIXES WINDOWS FLOW-CHART Note: The dotted blocks are functioning only if the modem is enabled. Rev. 0 del 06/2012...
Page 90: Touch Screen Calibration
CHORUS Manuale operativo TOUCH SCREEN CALIBRATION Calibration of the touch screen is activated, when chosen by the operator, during the starting procedure of the instrument, pressing the screen within 5 seconds from the moment the first empty screen is formed (see fig. 102) fig.
Page 91 CHORUS Manuale operativo If the pressure is not maintained for all 5 seconds, or if the press point is not stable, it is requested to repeat the operation. If, after 5 tries, the calibration operation of the edge fails, the calibration is interrupted and the instrument continues the starting procedure.
Page 92: Analytic Evaluations
CHORUS Manuale operativo ANALYTIC EVALUATIONS Determining the final test result (titration) is based on the mathematical processing, by dedicated algorithms, of the six optical densities (OD1 to OD6) that were detected in the respectively optical channels (Ch1 to Ch6) in three different times (t1, t2 and t3) of the kinetics of the reaction, which represent how the color of the solutions, that are reacting in well 5 or 6 of the strip, changes.
Page 93: Kinetics Acceptance
CHORUS Manuale operativo In case the test requires an analytical calibration, the corresponding data must be stored in the memory beforehand since the mathematical algorithm processes them as described below. The aim of this paragraph is to indicate the main elements of the different steps of the analytical evaluation routine which is carried out by the mathematical algorithms.
Page 94: Titration In The Qualitative Tests
CHORUS Manuale operativo The OD is then compared to the acceptability upper and lower limits ( 100 – 1000 ) defined by the method parameters. If OD complies with the parameters, • OD ≥ OD ≥ OD upper lower Its value is stored in the memory; otherwise, either error Cal Low , or Cal High arises and the calibration fails.
Page 95: Calibration In The Quantitative Tests
CHORUS Manuale operativo 5.3.3.1 Quality control The check routine of the QC involves processing the QC of a test batch with the corresponding strip in the standard mode, as a sample. Once the optical density of the QC has been determined, = OD3 –...
Page 96: Titration In The Quantitative Tests
CHORUS Manuale operativo The calibration curve is stored in the memory of the instrument. I1 = I4 = I3 = I5 = ODcal ODcal ODcal ODcal fig. 111 5.3.5 ITRATION IN THE QUANTITATIVE TESTS The sample is processed with one strip of a test batch and its optical density is thus determined: = OD3 –...
Page 97: Avidity
CHORUS Manuale operativo R% = (T ) *100 10 ng/ml 5.3.5.2 Quality control The verification routine of the QC involves processing the QC of a test batch with the corresponding strip in the standard mode, as any sample. Once the optical density of the QC has been determined, = OD3 –...
Page 98: Screen Test
CHORUS Manuale operativo In the opposite case, the percentage of Avidity is determined by index I ( %Av ) = OD x 100 / OD urea The result is then determined by the following comparison results: • if I (%Av) > 40% High level ( H) •...
Page 99 CHORUS Manuale operativo 5.3.7.2 Quality control with direct index After determining = OD3 – OD1 Calculate index: • I = OD / OD • And make sure that : ≥ I ≥ I • upper lower Where the limits I are contained in the QC barcode.
Page 100: Cft
CHORUS Manuale operativo 5.3.8 The test foresees the execution at the same time of the following: • Anti-complementary power of the sample (ACP) in well 6 (blu curve) • Reaction Sample-Antigen in well 5 (green curve) The cycle is carried out in 3 reading operations (R1, R2, R3) for both the reaction with the antigen and the anti-complementary power (ACP).
Page 101 CHORUS Manuale operativo c) Antigen determination The routine continues with: > OD1 x ACP% ant. The value >1/128. (fig 18 b) is given as titer < OD1 x ACP% ant. The routines continues with the titration of the sample, phase d) ACP % A.C.P...
Page 102 CHORUS Manuale operativo d) Sample titration Near the threshold value of ACP% the times concerning the two kinetics are evaluated and factor ∆ ∆ ∆ ∆ t is calculated. On the basis of ∆ ∆ ∆ ∆ t (Antigen Anticomplementary Power) parameter that is detected on the label of the strip, the titration is carried out as follows: •...
Page 103: Troubleshooting
CHORUS Manuale operativo TROUBLESHOOTING An error detection procedure in background is present on the instrument, to alert the operator of possible anomalies during functioning with a message on the status-bar. This chapter reports the actions that should be taken in case these errors occur.
Page 104: Errors In Functioning
CHORUS Manuale operativo 5.4.2 RRORS IN FUNCTIONING 5.4.2.1 Warnings Printer paper empty Description: the paper is lacking in the printer Corrective action: replace the roll of paper Lever printer lifted Description: the printer carriage is open Corrective action: lower the lever of the paper carriage...
Page 105: Recoverable Errors
CHORUS Manuale operativo 5.4.2.2 Recoverable Errors Clean Sol. 0% Clean Sol. < 25% Clean Sol. < 50% Clean Sol. < 75% Wash buf. 0% Wash buf. < 25% Wash buf. < 50% Wash buf. < 75% Sanit. Sol. 0% Sanit. Sol. < 25% The errors in the tank levels (33-42) are generated when the tank is checked before using the liquid contained in it.
Page 106 CHORUS Manuale operativo Loading bitmaps ..DATA ERROR Description Detection of corrupted data during the loading of the bitmaps Loading fonts…ERROR: Description Detection of corrupted data during the loading of the character fonts Loading HW parameters…NOT FOUND Description Detection of corrupted data during the loading of the HW parameters.
Page 107 CHORUS Manuale operativo Disp. #1 level sens. Description: error in the level sensor of dispensator 1 X carriage assembly Tray assembly Syringe assembly Disp. #1 assembly Disp. #2 assembly Washer #1 assembly Washer #2 assembly Washer #3 assembly OptFilter assembly TSD assembly The fatal errors (77 - 86) are related to the check of the movement of the relative groups.
Page 108 CHORUS Manuale operativo Wsh#2 coll.well filling Description: error due to the collection well of the washing station 2 which was not filled Wsh#1 coll.well voiding Description: error found due to the collection well of the washing station 1 which was not emptied Wsh#2 coll.well voiding...
Page 109 CHORUS Manuale operativo Washer#2 suct. (well#5) Description: error found at the start of the hydraulic check, due to incorrect aspiration of washer 2 from well n°5 of the test strip Washer#2 fill. (well#5) Description: error found at the start of the hydraulic check, due to incorrect dispensation of washer 2 from well n°5 of the test strip...
Page 110: Identification Errors
CHORUS Manuale operativo The errors from 138 to 143 may be found during the optic check, and indicate poor function of the offset regulation of the channel indicated Channel #1 dark Channel #2 dark Channel #3 dark Channel #4 dark...
Page 111: Errors During The Cycle
CHORUS Manuale operativo CAL NR Description: more than one calibrator was found for the same batch CAL/STR Description: the calibrator is associated to a different test or batch QC/STR Description: the control serum is associated to a different test or batch...
Page 112: Analytical Errors
CHORUS Manuale operativo DISPSYR#1 Description: the 250ml syringe did not dispense the correct quantity of liquid because of a loss of steps of the instrument The error code is S1 DISPSYR#2 Description: the 25ml syringe did not dispense the correct quantity of liquid because of a loss of steps of the instrument.
Page 113: Cycle Messages
CHORUS Manuale operativo 5.4.3 YCLE MESSAGES Messages regarding the test results Description: Anti Complementary Power (CFT). Description: Sample to concentrated. Dilute as described in the instructions for use of the kit N.C. Description: Sample can not be evaluated Rev. 0 del 06/2012...
Page 114: Identification Of The Tanks
CHORUS Manuale operativo 5.5 IDENTIFICATION OF THE TANKS The identification is started: - for all tanks every time the instrument is switched on; - for a specific tank that has to be substituted as soon as the probe from that tank is removed;...
Page 115: Identification Of The Buffer Solution For Infectious Diseases
CHORUS Manuale operativo In case the Cleaning solution identification procedure is skipped, the instrument will not allow you to execute the hydraulic check, since the cleaning solution is a necessary requirement for this test. Furthermore, the instrument will not start a working cycle until the cleaning solution is identified properly.
Page 116: Identification Of The Buffer Solution For Autoimmunity
CHORUS Manuale operativo If the Skip key is pressed, the instrument will not permit you to start the priming of the autoimmunity buffer solution which was selected as current buffer. It will not be possible to start a working cycle until the buffer solution is identified correctly.
Page 117: Note
CHORUS Manuale operativo If the Skip key is pressed, the instrument will not permit you to start the priming of the autoimmunity buffer solution which was selected as current buffer. It will not be possible to start a working cycle until the buffer solution is identified correctly.
Page 118: Chorus Hosting
In this case, the term “Host-Computer” is often used. In general, the term “CHORUS Hosting” means the interface between the analyzer and the computer, to allow tests to be programmed on the instrument and corresponding results to be received with the aid of a Computer.
Page 119: Interface Programming
NTERFACE ROGRAMMING Pinout of the Host connection cable is shown in the following picture (pins shown as unconnected may or may not be connected because not used) To CHORUS To Computer MALE CONNECTOR DB9 FEMALE CONNECTOR DB9 Standard Serial Cable...
Page 120: Serial Communication Frame
Eg. string text is represented by the sequence 0x74 0x65 0x78 0x74 0x00 5.6.5 NQUIRY Before sending the sample list (see chapter 5.6.6) or session results (see chapter Errore. L'origine riferimento non è stata trovata.), the CHORUS checks Computer availability with the following frame: → CHORUS Computer...
Page 121: Sample Programming
5.6.6 AMPLE PROGRAMMING After receiving each sample code inserted by the user, the Computer sends the CHORUS the list of tests to be executed on that sample. This is called Job-List (J-List). After establishing a connection between the Computer and the CHORUS (see chapter 5.6.5), the instrument sends, for each inserted sample, the following frame: →...
Page 122 SampleCode field contains 19 characters (including trailing character). Note: Since the total number of storable tests of the CHORUS is limited, the Computer must not send a number of TestID records greater than StorableRec. Therefore there is the possibility that not all of the relative ID for a given sample can be sent, because of space.
Page 123: Result Management
5.6.7 ESULT MANAGEMENT After each cycle, in the result window, or anytime from the session archive, the CHORUS can send the Computer sample results, in order to archive or elaborate them. After establishing connection between the Computer and the CHORUS (see chapter 5.6.5), the instrument sends the following frame for each sample processed in this session: →...
Page 124 CHORUS Manuale operativo The Computer answers with the following frame: → Computer CHORUS After sending all result frames, the CHORUS sends the following closing frame: → CHORUS Computer ResEnd InstrID Field Description Value Data type Bytes ResEnd Result text sending end command...
Page 125 CHORUS Manuale operativo → Computer CHORUS 0x02 0x01 0x04 0x05 → CHORUS Computer 0x02 0x02 0xD8 0x43 0x99 → Computer CHORUS 0x02 0x01 0x04 0x05 Rev. 0 del 06/2012...
Page 126: Ec Declaration Of Conformity
CHORUS Manuale operativo EC DECLARATION OF CONFORMITY Rev. 0 del 06/2012...
Page 127 CHORUS Manuale operativo Rev. 0 del 06/2012...

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