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Cypress Diagnostics CYANExpert 130 User Manual

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  • Page 2 CY008 CYANExpert 130 User Manual For a clear and precise diagnose  ISO 9001:2008 ISO 13485:2003 www.diagnostics.be Langdorp • Belgium • Tel: ++ 32 16 44 63 89 • Fax: ++ 32 16 44 77 62 • e-mail: cypress@diagnostics.be...
  • Page 3 DAILY ROUTINE Chapter 05 METHODOLOGY Chapter 06 CALIBRATION CURVES Chapter 07 MAINTENANCE Chapter 08 FORMULAS AND CALCULATION MODELS Chapter 09 ERROR SIGNALING AND TROUBLESHOOTING Chapter 10 PACKING LIST Chapter 11 DIAGNOSTIC PROGRAM CYANExpert 130 User Manual Rev.01, Sept 2013 Page 1...

  • Page 4: Table Of Contents

    Install additional methods (if necessary) ........................13 1.3.4.2 Configure the user specific options ..........................13 1.3.4.3 Create user profiles ................................13 1.3.5 ! .......................13 IVE EXTENSIVE EXPLANATION TO THE USER CYANExpert 130 User Manual Rev.02, Feb 2014 Chapter 1, Page 1...

  • Page 5: Unpacking

    Chapter 01 - INSTALLATION 1.1 UNPACKING The CYANExpert 130 is packed and delivered in a wooden crate with an adjoining cardboard box. The wooden crate contains the analyzer itself. The accessories are packed in the cardboard box. The packing has been expressly studied and designed to insure maximum protection of the contents during shipping and handling.
  • Page 6 Remove the adhesive tape from the cover of the samples and reagents housing, from the front panels and from the samples and reagents racks. Before connecting the CYANExpert 130, remove the protective packing material around the sampling arm and under the washing station.

  • Page 7: Installation

    OCATION PECIFICATION Verify that the CYANExpert 130 is not exposed to direct sunlight, draughts, dust or strong magnetic fields. In addition, please take note of the following conditions required for the location of the installation: In a covered and dry place...

  • Page 8: Abel And Symbols

    Ground terminal (conductor) Wash bottles connection I Rinse Solution II Distilled water III Cleaning Solution IV Acid Solution Stand-by button CYANExpert 130 User Manual Rev.02, Feb 2014 Chapter 1, Page 5...

  • Page 9: Regulatory Compliance

    1.2.5 IMITATIONS OF USE The CYANExpert 130 cannot be used by blind operators because the user interface with the system requires a monitor. Furthermore the CYANExpert 130 must be used with particular caution by color blind operators because the graphic interface displays different colors with different meaning.
  • Page 10 CY008-S40 Micro-Pump assembly (μP 2 to 5) CY008-S54 Air Micro-Pump assembly (μP 6) CY008-S55 Solenoid Valve –2 way CY008-S58 Solenoid Valve –3 way CY008-S59 Interferential filters kit (Stablife) CY008-S64 CYANExpert 130 User Manual Rev.02, Feb 2014 Chapter 1, Page 7...

  • Page 11: Brief Installation Procedure

    Chapter 01 - INSTALLATION 1.3 BRIEF INSTALLATION PROCEDURE The installation of the CYANExpert 130 instrument should be performed by a qualified service engineer! 1.3.1 OFTWARE INSTALLATION By service engineer 1.3.2 CCESSORIES ONNECTIONS Please follow these instructions carefully in order not to damage any parts of the instruments.

  • Page 12: Hydraulic Connections

    1. Biological hazard or biohazard: sample and reagents Silicon tubing Øi2-Øe4 2. Limited biohazard: minimal contact with sample and reagents Silicon tubing Øi2-Øe4 3. No biohazard PVC tubing Øi2-Øe6 CYANExpert 130 User Manual Rev.02, Feb 2014 Chapter 1, Page 9...

  • Page 13: Pump Tube Connection

    Manually rotate clockwise the peristaltic pump rotor and check to make sure that the tubes are correctly positioned insides the guides. Hooked hinged guide Close the peristaltic pumps’ door. CYANExpert 130 User Manual Rev.02, Feb 2014 Chapter 1, Page 10...

  • Page 14: Sample Probe Installation

    Open the “Diagnostic” program; select "Miscellaneous” folder and request an Instrument General Reset. Wait until the general reset procedure has been completed; make sure that all the Home Sensors of the Sampling Arm (Vertical and Horizontal), Reactions, Reagents and Samples Plates light up in green. CYANExpert 130 User Manual Rev.02, Feb 2014...

  • Page 15: Reaction Rack Installation

    Turn the two metal locking pins back to their original position. Turn the plate by using the “load reaction rack” button in the software interface and perform the same for the other 5 reaction racks. CYANExpert 130 User Manual Rev.02, Feb 2014...

  • Page 16: Checking The Analyser

    Teach them how to run the tests and check the results. Always do some tests together with the customer in order to teach them how to use the CYANExpert 130! In order to protect the sampling probe and its level sensor, always make sure the programmed type of sample...

  • Page 17: Chapter 02 - General Description

    SOFTWARE AND COMPUTER SPECIFICATIONS ..............9     TECHNICAL & OPERATIVE FEATURES ..................9     DIMENSION, WEIGHT and ENVIRONMENT ................10     INSTALLATION SPECIFICATIONS ..................... 10     CYANExpert 130 User Manual Rev.02, Feb 2014 Chapter 2, Page 1...

  • Page 18: Intended Use And System Description

    “CYANExpert 130" icon on the computer desktop. The login menu will appear. NOTE: The CYANExpert 130 is a system that allows configuration with different reagents selected by the customer in order to fit his needs. Upon delivery, the instrument is configured for the validated biochemistry kits of Cypress Diagnostics.

  • Page 19: Main Components And Analyse Cycles

    LATE DESCRIPTION: The reaction plate of the CYANExpert 130 contains 6 semi-disposable racks with 20 reaction cuvettes each. The racks can be removed individually. However, it is recommended to replace them together. The basic operating cycle of the reaction plate takes 26 seconds. This cycle includes the optic reading of the cuvettes in incubation, the aspiration and dispensation of the reagents and the samples by the arm, along with the relative positioning of the plate.

  • Page 20: Washing Well

    Sample racks can be continuously loaded during running. The CYANExpert 130 is delivered with 4 racks for primary tubes. They each contain 8 sample positions and 8 corresponding predilution positions. This rack can be used with primary tubes and 3 ml cups.

  • Page 21: Sampling Arm

    5. The arm is raised from the washing well and moves to the specified sample while aspirating a third air bubble; 6. Once the level sensor detects the presence of liquid, the arm stops and aspirates the sample; CYANExpert 130 User Manual Rev.02, Feb 2014...
  • Page 22 (To prevent sample loss) External probe cleaning above washing well Aspiration of Air Dispensing and mixing in cuvette External and internal probe cleaning above washing well with rinse solution CYANExpert 130 User Manual Rev.02, Feb 2014 Chapter 2, Page 6...

  • Page 23: Washing Station

    All these operations are part of the routine operation of the instrument. Every reaction cuvette is washed at the end of each round of analysis and the reusability (optical integrity) of each reaction cuvette is also tested, thus before the next round of analysis. CYANExpert 130 User Manual Rev.02, Feb 2014...

  • Page 24: Incubator

    Red: flickers when the instrument is running and in case of barcode readings. 2.2.10 B ARCODE EADER Reading samples and reagent with a barcode reader is an optional feature. CYANExpert 130 User Manual Rev.02, Feb 2014 Chapter 2, Page 8...

  • Page 25: Software And Computer Specifications

    NOTE: Even though the computers demonstrate the same technical and operative characteristics, some of these could have different hardware installed. This could cause problems for the CYANExpert 130- software when running tests (‘Random’ error or blocking of the program). Please contact your local distributor in case of any problems.

  • Page 26: Dimension, Weight And Environment

     No Break module UPS - (Uninterrupted Power Supply) This module provides two important functions: - stabilizes the main-line power - supplies current to the instrument in case of a main-line power failure CYANExpert 130 User Manual Rev.02, Feb 2014 Chapter 2, Page 10...
  • Page 27 ............................41 UALITY ONTROL ESULTS 3.5.7 R ..............................43 ECEIVE FROM ARCHIVE ............................44 3.6.1 P ..................................44 ATIENTS 3.6.2 C ................................46 ALIBRATION 3.6.3 B ..................................48 ACKUP CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 1...
  • Page 28 ................................ 68 EPORT PTIONS 3.7.10 A ................................... 69 CCOUNTS HELP ............................... 71 3.8.1 G ..................................71 UIDE 3.8.2 I ....................................71 LOG OFF ............................72 3.10 SHUT DOWN ..........................73 CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 2...

  • Page 29: System Monitor

    Pay attention: The CYANExpert 130 should be linked to a designated PC used only to run the CYANExpert 130 program. It is impossible to run other programs when the analyser is in use.

  • Page 30: Main Taskbar

    Sample plate composed of four racks with eight positions for sample cups and corresponding 8 predilution positions or a predilution rack with 25 positions.  Reaction plate composed by six racks with twenty cuvettes. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 4...

  • Page 31: View Data /Details Area

    (SID), rack and position) will appear in the upper portion of the window. In the lower portion of the window, a table listing the tests programmed to run (pending) on that sample will appear or information concerning the results if the test is already run. CYANExpert 130 User Manual Rev.02, May 2014...

  • Page 32: Legend

    Remarks:  Cypress 35 mL bottles are indicated in white, 6 mL bottles in sky-blue. The other bottle colours are currently not used. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 6...

  • Page 33: Command Buttons

    “Set”. The selected name will be listed in the “Sort Key List” area, ready to be re-ordered. By selecting a name and clicking on “Remove”, the name can be removed again from the ‘Sort Key List’-area. CYANExpert 130 User Manual Rev.02, May 2014...
  • Page 34 Select the row in the Details Area and then either double click on it with the mouse or click on the “Graph” button. This Graph button is activated only when the Details Area contains at least one row of data. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 8...
  • Page 35 Furthermore, an “E” will be shown in the Flags column and on the print report, indicating an Edited Result. The Exit button allows the operator to annul the editing operation. CYANExpert 130 User Manual Rev.02, May 2014...
  • Page 36 If the user places the mouse pointer over an icon, a visual text message will appear describing the corresponding function, if the function is active. CYANExpert 130 User Manual Rev.02, May 2014...

  • Page 37: Operative Buttons

    After physically replacing the rack, confirmation should be done by clicking again “OK” in the newly opened window. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 11...
  • Page 38 Note: Reagents can only be loaded in the running condition. Pushing the load button brings the analyser from the Running to the Pausing and finally to the Pause condition, to allow the reagents to be loaded. CYANExpert 130 User Manual Rev.02, May 2014...

  • Page 39: Warning Lights

    Status: Stand By, Stop, Washing, Running WBL, Running, Pause, Pausing, Safe, Priming  Icon indicating a fault sample reading executed by the Bar Code reader  The firmware version is shown when passing over it with the mouse pointer CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 13...

  • Page 40: Start Work

    “Water Blank Level” menu - Checks, or in the Details Area by selecting the reaction cuvette on the System Monitor. Note: Make sure the Rinse solution bottle (I) is sufficiently filled. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 14...

  • Page 41: Predilution Rack ( S ) Replaced

    The instrument program will carry out any (programmed) automatic rerunning of the tests without the need for the operator to intervene. Further rerunning can be requested only after testing has been completed and before rack replacement. CYANExpert 130 User Manual Rev.02, May 2014...

  • Page 42: Operational Menu (Main Taskbar)

    12 that is dedicated to distilled water.  Predilution: contains all that data regarding the positions dedicated to sample predilution as set-up in the “Reagent Configuration” mask. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 16...

  • Page 43: Water Blank Level (Wbl)

    28000 and 63000 counts. The Details area gives the values for all the positions of the photometer filter wheel, both for the reference and the sample channel. A. Main area B. Details area CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 17...

  • Page 44: Reagents Volume

    By using the Print button, on the left of the interface, the data can be printed. This window is divided into two sections, Main area (A) and Details area (B). CYANExpert 130 User Manual Rev.02, May 2014...
  • Page 45 If a control is selected in the Main area, the Details area will show the type, name, lot number, and expiration date. If a calibrator is selected in the Main area, the Details area will show the type, name, lot number, expiration date, the number of points, and the corresponding diluent. CYANExpert 130 User Manual Rev.02, May 2014...

  • Page 46: Reagents Configuration

    Programmed methods: Checked in the (all) method list and listed with their corresponding position on the plate and container volume indicated in sky blue (6 mL) or white (35 mL). Programmed controls with their corresponding position. Number of predilution racks. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 20...
  • Page 47 Exit button The “Exit” button allows to close the Reagents Configuration mask and to return to the System Monitor without saving any modifications. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 21...

  • Page 48: Predilution

     Predilution Ratio: indicates the predilution ratio of the sample as set-up in the corresponding method. By using the Print button, on the left of the interface, the data can be printed. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 22...

  • Page 49: Routine

    C. Right-hand side of the screen, dedicated to the methods, profiles and ratios requested for a specific patient. D. Lower portion of the screen that contains those buttons necessary for the various management operations regarding the mask. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 23...
  • Page 50 When selecting a cup/SID, the sample’s corresponding personal data is shown in the central area of the Samples card; and the requested methods, in the right area of the Methods card. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 24...
  • Page 51 Once the sample has been saved, the PID can no longer be changed. At this point it will appear coloured dark grey. Last Name The patient’s last name (family name/surname) First Name The patient’s first name (given name) CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 25...
  • Page 52 For serum samples, it is important that they are well coagulated and then carefully centrifuged, residual fibrinogen clots can obstruct the probe and lead to inexact sampling.  If blood samples containing gel are used, it is suggested that the manufacturer’s recommendations be followed. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 26...
  • Page 53 Grey: reagent not programmed. Click the “check boxes” (√) to program the requested methods for that patient. The tests highlighted in blue will be run when the sample rack is loaded and the CYANExpert 130 User Manual Rev.02, May 2014...
  • Page 54 To save a programming of data that are the same for more than one patient, use patient the “Save for…” button (e.g. more than one patient has the same methods programmed). The following dialog box will appear: CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 28...
  • Page 55 By transferring the data to the archives, the rack position will automatically become free again. To exit the work list mask and return to the System monitor. CYANExpert 130 User Manual Rev.02, May 2014...

  • Page 56: Result B Y Patient

    The rack number and position/cup in the rack used for that sample Type Type of sample used Samp. Dil. Dilution ratio used for the sample Sample identification number Patient identification number Name, Sex, Birthdate As programmed in the work list CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 30...
  • Page 57 Deleting a sample rack or a sample in the work list menu without first archiving the data implies loss of the data! Archived data cannot be edited or re-run anymore.  Unload button to send the data to the Host computer CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 31...

  • Page 58: Result By Test

    The errors are signalled using letters that stand for the type of error encountered – as reported in Report Options - Flags Description. This field allows the operator to view if any errors occurred during operation. CYANExpert 130 User Manual Rev.02, May 2014...

  • Page 59: Calibration

    (photometer lamp, dilutor module, etc.) Prior to any calibration, it is mandatory that calibrators and quality controls are correctly programmed in the Parameter menu for the respective methods (see 3.7.3 and 3.7.4). CYANExpert 130 User Manual Rev.02, May 2014...
  • Page 60 The number and the name of the calibrators are shown in blue, if they are still to be assigned and saved, or in black if already assigned and confirmed; Attention: Expired calibrators (past expiration date) will not be shown. CYANExpert 130 User Manual Rev.02, May 2014...
  • Page 61 Make any necessary changes and then click “Assign/Check”. A calibration request message will appear informing the user of the number of operations already assigned: CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 35...
  • Page 62 By clicking “Yes”, the pending calibration(s) are deleted, and the calibration is no longer valid. Click “No” to annul the request to delete. To close the Calib. and Q.C. Setup and return to the system monitor. CYANExpert 130 User Manual Rev.02, May 2014...

  • Page 63: Calibration Results

    When an error did occur, all the fields regarding that item are automatically shown coloured red. Errors are signalled using letters which stand for the type of error encountered – as CYANExpert 130 User Manual Rev.02, May 2014...
  • Page 64 Errors are signalled using letters which stand for the type of error encountered – as reported in Report Options - Flags Description. CYANExpert 130 User Manual Rev.02, May 2014...
  • Page 65 – as reported in Report Options - Flags Description. Recalculated The new calculated value obtained with relation to the type of calculation algorithm. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 39...
  • Page 66 In order to memorize and use the settings programmed in this mask, click “Save”. To print the graph and the associated data. This button is deactivated during editing, but is automatically reactivated once the edited data has been saved. CYANExpert 130 User Manual Rev.02, May 2014...

  • Page 67: Quality Control Results

    The name of the method and the associated unit of measurement programmed. CONTROL Name The name of the control, lot number and expiration date. REFERENCE Mean The mean reference value as defined in Parameters - Controls. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 41...
  • Page 68 “Graph” button. This Graph button is activated only when the Details Area contains at least one row of data. Click “Exit” to return to the Q.C.Results mask. CYANExpert 130 User Manual Rev.02, May 2014...

  • Page 69: Receive From Host

    Host. In order to view the item, the user must first select “Host Connection” in Parameters - Options. For further information regarding data transmission, see service manual chapter 8 - Host Communication. CYANExpert 130 User Manual Rev.02, May 2014...

  • Page 70: Archive

    Insert the desired search criteria. Click “OK” to confirm the selection. The program will pull up all the data contained in the Archive that match the entered criteria (AND-AND relation). To annul the selection, click “Exit”. CYANExpert 130 User Manual Rev.02, May 2014...
  • Page 71 The predilution ratio. The sample’s identification number. The patient’s identification number. Name The name of the patient. Sex and Birthdate The sex and date of birth of the patient. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 45...

  • Page 72: Calibration

    3.1.5.  Sort button to reorder the viewed data.  Print button to print the selected data.  Graph button to view the absorbance graph of the selected test. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 46...
  • Page 73 The measurement unit used. Factor The factor resulting from the calibration procedure for that test. Flags Shows if any errors occurred during operation. If an error occurred a character with a small CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 47...

  • Page 74: Backup

    This window allows recopying data back into the Archive. These data are copied from the memory device that was previously used for performing a Backup, and are hereby reinserted into the program, where they can be accessed for reference and/or for performing various other operations. CYANExpert 130 User Manual Rev.02, May 2014...

  • Page 75: Test Counter

    How many times that particular test was performed, total of all operations. How many RBLs (Reagent Blanks) were carried out for that specific test. The total number of calibrators carried out for that particular test. CYANExpert 130 User Manual Rev.02, May 2014...

  • Page 76: Event Log

    The following mask will open. The administrator can indicate the time interval from which he wants to see all the data. By clicking OK, all the actions of all the users will be indicated, with their respective time and date. CYANExpert 130 User Manual Rev.02, May 2014...

  • Page 77: Parameters

    Select Parameters and from the options listed, click Reagents ID. Item Description All methods currently programmed in the software. See Parameters  Methods. Test Reagent All reagents codes (Rgt. Code) currently programmed in the parameters section of the CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 51...

  • Page 78: Profiles

    Select Parameters and from the options listed, click Profiles. Section Description Profiles List List of the profiles programmed, listed in alphabetical order. Details List of the methods programmed in the “Methods” mask, listed in alphabetical order. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 52...
  • Page 79 (maximum: 12 alphanumeric characters).  Confirm the name by clicking “OK” (clicking on “Exit” will cancel the “Add” operation). The new profile will be listed along with the other already existing profiles. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 53...

  • Page 80: Ratio

    There is no limit to the number of ratios the user can define. Select Parameters and from the options listed, click Ratio. A. Description Area B. Calculation Area CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 54...
  • Page 81 – the activated fields appear coloured blue. Expression To view the programmed ratios. Please note that in this field the LIS Code of the selected Tests are shown. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 55...

  • Page 82: Calibrators

    This area contains a list of the programmed calibrators, listed in alphabetical order. If a calibrator is selected from the list, the methods associated with that calibrator along with their relative values are automatically displayed in the Details area. CYANExpert 130 User Manual Rev.02, May 2014...
  • Page 83 To copy a selected calibrator, but enter new calibrator details and test values. Delete CAL To delete a calibrator from the list of calibrators. Add Tests To add a test to a calibrator included in the list of calibrators. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 57...
  • Page 84 1-point calibrator, only those tests defined with “calibrator” as calculation Model (Parameters  Methods) will be listed. If the calibrator requires 2-points or more, then the list will only contain those methods defined as multipoint calculations. CYANExpert 130 User Manual Rev.02, May 2014...
  • Page 85 Select the calibrator to be deleted from the “Calibrators List”.  Click on the button. The “Delete Calibrator” dialogue box will automatically open.  Confirm the deletion request by clicking “Yes”; clicking “No” will cancel the delete operation. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 59...

  • Page 86: Controls

    This mask allows the user to program the quality controls along with the relevant methods. Select Parameters and from the options listed, click Controls. B. Details Area C. Operative Area CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 60...
  • Page 87 To add a new control to the list of controls. Copy as New To copy a selected control, but enter new control details and test values. Delete CTRL To delete a control from the list of controls. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 61...
  • Page 88 Select the method(s) required from among those options offered in the “Add Tests” menu.  Click “OK” to confirm the method(s) chosen; clicking “Exit” will cancel the selections made.  Define for each of the previously selected method(s) the following configuration parameters: CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 62...
  • Page 89 Select the method(s) to be deleted from among the choices offered in the “Delete Tests” window.  Confirm the deletion of the method(s) from the required control by clicking “OK”; clicking “Exit” will cancel the delete test operation. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 63...

  • Page 90: Options

    Clicking “Exit” allows closing the mask and returning to the “System Monitor” mask. 1.7.6 PTIONS This mask allows defining a series of default parameters for the analyser. Select Parameters and from the options offered, click on “Options”. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 64...
  • Page 91 In order to save and use the settings programmed in this mask, click “OK”. Changing the settings is only possible when the instrument is in the Stand-by status. To exit the Options and return to System Monitor, click “Exit”. CYANExpert 130 User Manual Rev.02, May 2014...
  • Page 92 Parameters  Reagents ID (see 3.7.1).  Read the reagent barcode: Checks  Reagents configuration  Barcode button (see 3.4.3). The following instruction will appear. Remove sample rack “A” and click “OK” to confirm. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 66...

  • Page 93: Sampling Order

    Methods still indicated with a 0 will not get any priority and will be examined after the other tests. To save, click “OK”. The order of the tests can be also printed by clicking on the “Print” button. CYANExpert 130 User Manual Rev.02, May 2014...

  • Page 94: Print Order

    Header Text area, where up to 800 characters can be inserted to make a specific laboratory heading for the reports. Confirm by clicking “OK”.  Warning message area, containing a Warning message on the right and the flags list with the following fields on the left: CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 68...

  • Page 95: Accounts

    Click on “change password” in the account menu.  Give in the new password and confirm it.  To save, click “Change”. Clicking “Exit” allows closing the mask without saving any changes. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 69...
  • Page 96 (), they are activated for the user. Locked: An account can be locked totally, in case of total restriction of the user using this analyser. The user will not be able to log-on. CYANExpert 130 User Manual Rev.02, May 2014...

  • Page 97: Help

    Select “Help” and from the options listed, click “Info”. To close this window, exit the Info mask and return to the main mask by clicking on “Exit”. CYANExpert 130 User Manual Rev.02, May 2014...

  • Page 98: Log Off

    To access the system, enter User ID and Password. To confirm the data entered in the “Login” window, click “Log On”. Note: To avoid improper use of the instrument under your own login, please always log off when you are leaving the laboratory. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 72...

  • Page 99: Shut Down

    Once Shut Down is completed, the instrument can either be turned off or left on – in stand-by – ready to be reactivated for another work cycle. During Stand-by, the instrument will maintain the following conditions:  Heating of the reaction plate;  Reduced power (voltage) to the photometer lamp. CYANExpert 130 User Manual Rev.02, May 2014 Chapter 3, Page 73...
  • Page 100 Chapter 04 - DAILY ROUTINE CHAPTER 04 – DAILY ROUTINE 4.1. DAILY ROUTINE............................2 4.2. STAND-BY FUNCTION ..........................3 CYANExpert 130 User Manual Rev.01, Aug 2013 Chapter 4 Page 1...
  • Page 101 2. Visually check the liquid level in the waste bottle(s), empty them if necessary. There is no level sensor for the waste. 3. If the CYANExpert 130 has remained unused for more than 24 hours (e.g. during the weekend), run a cuvette wash cycle by pressing the designated key in the "Start Work" mask.
  • Page 102 7. Print out the test results. 8. Transfer the completed samples to the Archive. 9. When the work has finished, click on the Shutdown key to exit the CYANExpert 130 program and switch off the computer and peripheral equipment. 10. Switch off the analytical module or leave it in Stand-by.
  • Page 103 CUVETTE WASHING WBL (WATER BLANK LEVEL) REAGENT CONFIGURATION REAGENT LEVELS QUALITY CONTROL RBL, CALIBRATOR & CONTROLS CALIBRATION & QC RESULTS PATIENT ENTRY START WORKLISTS RESULTS: ANALYSE, RERUN, PRINT & ARCHIVE CYANExpert 130 User Manual Rev.01, Aug 2013 Chapter 4 Page 4...
  • Page 104 DESCRIPTION AREA ........................3 5.2. REFERENCE AREA ........................4 5.3. REACTION AREA ........................4 5.4. CALCULATION AREA ........................ 7 5.5. STABILIZATION AREA ....................... 7 5.6. COMMAND AREA ........................7 CYANExpert 130 User Manual Rev.01, Aug 2013 Chapter 5 Page 1...
  • Page 105 5. Stabilization Area: contains the stability time for the reagent (RBL), calibrator and to test the stability of the reaction by measuring controls at multiple times. 6. Command Area: these buttons allow the user to save, add, copy, delete, print, exit, restore and backup the methods. CYANExpert 130 User Manual Rev.01, Aug 2013 Chapter 5 Page 2...
  • Page 106 CYANExpert 130 can be corrected by changing the slope and the intercept. In this calculation the original CYANExpert 130 result will be multiplied with the slope value (default = 1) and the intercept (default = 0) will be added. After calculation the new CYANExpert 130 result is equal to the result of Instrument X.
  • Page 107 This limit indicates exhaustion of the substrate and will automatically be flagged. This specific parameter is only applicable when using the “Kinetics” and “Fixed Time” methodologies. CYANExpert 130 User Manual Rev.01, Aug 2013 Chapter 5 Page 4...
  • Page 108 For the parameters listed below, it is possible to define the following information (when applicable):  Times (s)  Dil/Rgt.Code (Diluent or Reagent Code)  Lot number  Ratio/vol (μl)  Rinse (μl)  Sample (μl) CYANExpert 130 User Manual Rev.01, Aug 2013 Chapter 5 Page 5...
  • Page 109 The secondary filters are the same as those given above in the Filter 1 mask. Bichr. Factor The bichromatic factor allows the user to correlate the sample absorbance reading with the secondary filter (Filter 2) to the primary filter (Filter 1). CYANExpert 130 User Manual Rev.01, Aug 2013 Chapter 5 Page 6...
  • Page 110 This is used to insert a new method. It should be done by following the below instructions:  A new window “New test” requests the user to insert the short name of the test (from 1 to 6 characters max).  Push OK. CYANExpert 130 User Manual Rev.01, Aug 2013 Chapter 5 Page 7...
  • Page 111 Exit To return to the system monitor. For each selected Method, the disabled fields are highlighted opaque gray. The values of the enabled fields are given in black figures. CYANExpert 130 User Manual Rev.01, Aug 2013 Chapter 5 Page 8...
  • Page 112 ALIBRATORS UNDILUTED TYPE 6.1.3. M ......................2 ASTER ALIBRATOR DILUTED 6.1.4. M ......................3 ASTER ALIBRATOR UNDILUTED 6.2. CALIBRATION CURVE ......................3 6.3. PROGRAMMING A MULTIPOINT CALIBRATION ..............4 CYANExpert 130 User Manual Rev.01, Aug 2013 Chapter 6, Page 1...
  • Page 113 Only the cup containing the Master calibrator is available in the calibration rack. The system prepares the individual points of the calibration curve, starting from this Master calibrator. The instrument itself does the preparation, CYANExpert 130 User Manual Rev.01, Aug 2013...
  • Page 114 0 concentration CYANExpert 130 User Manual Rev.01, Aug 2013 Chapter 6, Page 3...
  • Page 115 6.3. PROGRAMMING A MULTIPOINT CALIBRATION In order to prepare a calibration curve, the operator must first select “Calibrators” from the “Parameters” menu. CYANExpert 130 User Manual Rev.01, Aug 2013...
  • Page 116 “System Monitor”, but only when this calibration is requested. 5. Press “Add Tests” to select those tests to be calibrated using that calibrator. CYANExpert 130 User Manual Rev.01, Aug 2013...
  • Page 117 N.B.: the percentages inserted must be in either increasing or decreasing order. If the Calibration Curve is a Ready-to-Use type (pre-prepared calibrators for the various points), the operator must insert in the “Ref.” field, the concentration value of the calibrators. CYANExpert 130 User Manual Rev.01, Aug 2013...
  • Page 118 14. Press “Start Work” under “System Monitor”. 15. After having placed the Reagent(s), Diluent(s), and the predilution cups (if necessary) in their respective positions, select “Calibration & Q.C.” in the “Start Work” window and then press “OK”. CYANExpert 130 User Manual Rev.01, Aug 2013...
  • Page 119 ASHING 7.2.5 – C & R RYER LEANING EPLACING 7.2.6 HANGING THE EACTION UVETTES 7.2.7 HANGING THE PERISTALTIC PUMP TUBES 7.2.8 ECONTAMINATION ROCEDURE MAINTENANCE FORM MAINTENANCE INSTRUCTIONS REPAIR FORM CYANExpert 130 User Manual Rev.02, May 2014. Chapter, 7 Page 1...
  • Page 120 Remove dust inside the instrument with pressurized (dry!) air Service Engineer NOTE: The above-described maintenance schedule refers to that situation in which the workload of the CYANExpert 130 is approximately 500 tests/day. The interval frequency may vary according to the individual instrument’s daily workload. CYANExpert 130 User Manual Rev.02, May 2014.
  • Page 121 How often the bottles must be cleaned depends on their use and on the quality of the distilled water used in that particular laboratory. However, Cypress Diagnostics recommends thorough washing at least once every two weeks. 1) Turn OFF the CYANExpert 130 analyser.
  • Page 122 How often the hydraulic circuit must be washed depends on the operating conditions/environment of the single instrument and on the quality of the distilled water used in that particular laboratory. Cypress Diagnostics recommends thorough washing at least once a month.
  • Page 123 Let it air-dry and reposition it. B. DRYER PAD REPLACING PROCEDURE Cypress Diagnostics suggests replacing the dryer pad every six months. This frequency may vary depending on the workload of the individual laboratory and the operating conditions/environment of the single instrument.
  • Page 124 Over time and through normal use, the perfect transparency of the cuvettes diminishes. This has a negative impact on the quality of the optical readings. Cypress Diagnostics suggests that the cuvettes are replaced after three to six months of use. The cuvettes racks are located inside the reaction plate.
  • Page 125 7) Turn ON the CYANExpert 130 and wait until the instrument has reached its proper operating temperature. 8) Have the instrument carry out a ‘Wash cuvettes’ cycle and then a ‘WBL’ cycle. Check the system efficiency by comparing the WBL values and the test results obtained against the laboratory’s quality control values.
  • Page 126 Material necessary ESOFENOL CYDIS Surface (delivered by Cypress Diagnostics) or a 6% solution (60 cc in one liter of distilled water). These are antibacterial and antiviral substances. Rubber gloves, mask & lab coat External surfaces and individual parts ...
  • Page 127 (date) CYANStart Delivered:  (date) CYANPlus End Warranty: Instrument:  CYANPro Serial number:  CYANExpert 130 (date) Last visit: Next visit: (date) Signature Laboratory Technician: Name Signature Maintenance Engineer: Name CYANExpert 130 User Manual Rev.02, May 2014. Chapter, 7 Page 9...
  • Page 128 Remove dust inside instrument  6 Months Replace the peristaltic pump tube 2000  Replace the lamp Hours  1 Year Replace the tubes  Problems Fill in repair form* CYANExpert 130 User Manual Rev.02, May 2014. Chapter, 7 Page 10...
  • Page 129 Please file the above documents, in order to track the different interventions. We suggest to keep the original together with the instrument and to deliver a copy to the maintenance engineer. CYANExpert 130 User Manual Rev.02, May 2014. Chapter, 7 Page 11...
  • Page 130 DEPLETION LIMIT WITH FIXED THRESHOLD ......................15 8.5.2. DEPLETION LIMIT WITH VARIABLE THRESHOLD ....................16 8.6. KINETIC METHODOLOGY ........................17 8.6.1. METHODOLOGY ................................17 8.6.2. TIMING OF THE KINETIC REACTIONS ........................18 CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 8, Page 1...

  • Page 131: End Point Methodology- Single Reagent

    = slope b = intercept The specific slope and intercept value for the adaptation of the result on the CYANExpert 130 must be defined under “Parameters  Methods” in the software interface. More information can be found in Chapter 5.
  • Page 132 The analytical result is obtained using the optical density readings at times T and T respectively as the first and second reading points. Absorbance (Abs) Sample/Cal +Reagent Abs (T Abs (T ~ RBL Time 1-13” INCUBATION CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 8, Page 3...

  • Page 133: End Point Limit Concept

    ) < End Point Limit 1 - 13" Add Sample/Cal+ Reagent Absorbance (Abs) Confidence limit Time The following example shows how the E.P. Limit value is calculated: 1 – 13" CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 8, Page 4...

  • Page 134: End Point Methodology - Two Reagents

    Add Reagent 2 Add Sample/Cal+ Reagent 1 Absorbance (Abs) Abs (T Time 1- 8" 2 - 13" INCUBATION R1 INCUBATION R2 CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 8, Page 5...
  • Page 135 Add Reagent 2 Add Sample/Cal+ Reagent 1 Absorbance (Abs) Abs (T Abs (T 1- 8" Time 1- 8" 2 - 13" INCUBATION R1 INCUBATION R2 CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 8, Page 6...
  • Page 136 Analytical Result = F x [[Abs (T ) – (Abs (T ) x VCF)] ± RGT Rate] 1-8” Analytical Result = 85.47 x [[0.1681 – (0.1336 x 0.9886)] - 0.0036] = 2.8 CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 8, Page 7...

  • Page 137: Rgt Rate Concept

    RBL (the value of the RBL is not taken in consideration for the calculation of the final result). In two reagent reactions, a reading is taken at time T and used as the basis for the calculation of the final result. 1 – 8” CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 8, Page 8...

  • Page 138: Differential

    E.P. Limit defined in the method programming. A 13sec small difference indicates that the end point method has reached its stable reading area. See paragraph 8.1.3. CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 8, Page 9...

  • Page 139: Bichromatic

    Reaction type Interference NADH dependent reactions Turbidity 405 nm + chromogen paranitrophenol, Icteric 492(460/500) paranitroaniline Trinder Hemolysis 578 (560/580) All reactions Turbidity 620 (600/700) CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 8, Page 10...

  • Page 140: Fixed Time Or Initial Rate Methodology

    The analytical result is obtained by the system using the Δ Abs obtained between Abs (T ) value as first reading point and Abs (T ) value as second reading point as described in the following formula: CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 8, Page 11...
  • Page 141 Analytical Result 0.2362 = F x (Δ Abs Sample ± RGT Rate) 0.2451 1 - 13" 0.3732 = 5.00 x [(0.6796-0.3732) - 0.015] 0.6047 2 - 13" = 1.46 0.6796 CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 8, Page 12...

  • Page 142: Monochromatic, Two Reagents

    The reagent rate is the mobility of the reagent itself during the reaction (Abs Rgt (T ) – Abs Rgt )). This value is automatically calculated during the calibration phase and it is memorized in CYANExpert 130 User Manual Rev.01, Sept 2013...

  • Page 143: First Limit Concept

    In case the following formula (Δ Abs1 - Lin Fact x Δ Abs2 < First Limit) is not satisfied, the result of the test carried out will be accompanied by the “A” flag. Add Sample/Cal + Reagent Absorbance (Abs) Abs2 Abs1 Time 1 -13" 2 -13" Incubation Reading CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 8, Page 14...

  • Page 144: Depletion Limit Concept

    (See Chapter 05 - Methodology), the results will be given with two asterisks accompanied by a flag “A”. POSITIVE REACTION (UP) Absorbance (Abs) FLAG “A” Depletion Limit Abs (T NO FLAG Abs (T Time READING INCUBATION CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 8, Page 15...
  • Page 145 = represents the Bichromatic Correction Factor = Segment B/Segment A Segment A = represents the absorbance value of the matrix filter 2. Segment B = represents the absorbance value of the matrix filter 1. CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 8, Page 16...

  • Page 146: Kinetic Methodology

    Absorbance Time Corrections to the Depletion Limit (DL) are carried out automatically by the CYANExpert 130 software program which controls both the methods UP and DOWN, with their combinations. In order to activate the automatic correction of the variable threshold for Depletion Limit control, the user needs to: 1.

  • Page 147: Timing Of The Kinetic Reactions

    = Maximum Incubation time (including reagent incubation time) • = Reading time inserted in the method parameter • Nr R = Number of readings carried out by the CYANExpert 130 to calculate the slope CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 8, Page 18...
  • Page 148 Chapter 08 - FORMULAS AND CALCULATION MODELS Nr R Nr R Nr R Nr R Nr R Reading every 13” Reading every 26” Reading every 39” Reading every 52” Reading every 65” CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 8, Page 19...
  • Page 149 ................................3 ESULT LAGS 9.2 T ........................5 ROUBLESHOOTING UIDE 9.2.1 ..................................5 ESULTS 9.2.2 ..............................6 YDRAULIC YSTEM 9.2.3 ................................ 7 PTICAL YSTEM 9.2.4 ................................7 OWER UPPLY CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 9, Page 1...
  • Page 150 Interlock open while Instrument is running  Macro send Error  Overflow Rx Buffer Micro  Time out Error (Generic error)  Invalid command error  Invalid parameter error  Check sum error CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 9, Page 2...
  • Page 151 High Alert Low Linearity Limit < Flag when the results are out-of-range as setup in the method. High Linearity Limit > Calculation Error Concentration calculation error unforeseeable causes (Asymptote). CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 9, Page 3...
  • Page 152 This can occur in the following situations: 1 – if the result is less than zero 2 – if the result is equal to zero OPTIC DENSITY ERRORS 3 – flag signalling inversion CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 9, Page 4...
  • Page 153  The lamp is not stable :  Check the WBL by performing a WBL cycle.  Check the D.Rel and D.Abs.  Replace the lamp (by service engineer). CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 9, Page 5...
  • Page 154  Contact service engineer.  Reaction cuvettes are not filled with solution.  Check if the four liquid bottles (rinse, distilled water, cleaning solution, acid solution) are sufficiently filled. CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 9, Page 6...
  • Page 155 The WBL cycle measurement is out of range for one of the filters.  Contact service engineer. 9.2.4 OWER UPPLY  Power supply Check it the connection of the power is correct and firm.  Check if the fuses are intact. CYANExpert 130 User Manual Rev.01, Sept 2013 Chapter 9, Page 7...
  • Page 156 Box N° 2 : cm 60x40x25 : 6 Kg : 5 Kg Code DESCRIPTION Q.ty CY008 Clinical analyser CYANExpert 130 – S/N: CY008-BC Barcode reader kit (optional) Software CYANExpert 130 – Rev. …………………. User manual with application sheets ACCESSORIES CY008-C08...
  • Page 157 ” F OLDER 11.3.8. “M ” F ISCELLANEOUS OLDER 11.3.9. “G ” F LOBAL ETTING OLDER 11.3.10. “M ” F ACRO ETTING OLDER 11.3.11. “C ” F ONFIGURATION OLDER CYANExpert 130 User Manual Rev. 01, Sept 2013 Chapter 11 Page 1...
  • Page 158 To launch the program, the operator has to left-click on the Diagnostic button located on the lower right side of the screen of the System Monitor, as illustrated in the figure below. The CYANExpert 130 must be in the stand-by state to access this area.
  • Page 159  Liquid 4 Status of the operator panel: Front panel button The following fields signal the state of the button on the CYANExpert 130 operator panel. They are green when the button is not pushed in, turn red if it is: ...
  • Page 160 Diagnostics 11.3 TEST FOLDER AREA The CYANExpert 130 diagnostic program is subdivided into 11 folders: Arm: To check the arm positions. Adjustments can be carried out. Diluter: To check if the diluter is functioning correctly. Optic: To check if the optical module is functioning correctly.
  • Page 161 (Miscellaneous folder). Certain commands can only be executed when the probe is in the required horizontal position. To select this horizontal position click “Go ….” in the horizontal command area (see below). CYANExpert 130 User Manual Rev. 01, Sept 2013...
  • Page 162 OLDER The Diluter folder is subdivided into four areas: OPERATIONS area: checking area SENSOR STATUS area : checking area USER area: checking area STATUS COMMAND area: checking area CYANExpert 130 User Manual Rev. 01, Sept 2013 Chapter 11 Page 6...
  • Page 163 Description Send Visualizes the commands sent from the program to the instrument hardware. Receive Visualizes the answers of the instrument’s hardware to the commands sent by the program. CYANExpert 130 User Manual Rev. 01, Sept 2013 Chapter 11 Page 7...
  • Page 164 The correct functioning of the reading/optic module is essential for accurate and precise measurements. In case of doubts about the reading/optic module, always contact your local distributor and its service engineer! CYANExpert 130 User Manual Rev. 01, Sept 2013 Chapter 11 Page 8...
  • Page 165 Visualizes the answers of the instrument’s hardware to the commands sent by the program. 11.3.4 “P ” F LATE OLDER All Motors On/Off Operations area area Status Command area CYANExpert 130 User Manual Rev. 01, Sept 2013 Chapter 11 Page 9...
  • Page 166 Description Send Visualizes the commands sent from the program to the instrument hardware. Receive Visualizes the answers of the instrument’s hardware to the commands sent by the program. CYANExpert 130 User Manual Rev. 01, Sept 2013 Chapter 11 Page 10...
  • Page 167 Description Send Visualizes the commands sent from the program to the instrument hardware. Receive Visualizes the answers of the instrument’s hardware to the commands sent by the program. CYANExpert 130 User Manual Rev. 01, Sept 2013 Chapter 11 Page 11...
  • Page 168 Description Send Visualizes the commands sent from the program to the instrument hardware. Receive Visualizes the answers of the instrument’s hardware to the commands sent by the program. CYANExpert 130 User Manual Rev. 01, Sept 2013 Chapter 11 Page 12...
  • Page 169 Description Send Visualizes the commands sent from the program to the instrument hardware. Receive Visualizes the answers of the instrument’s hardware to the commands sent by the program. CYANExpert 130 User Manual Rev. 01, Sept 2013 Chapter 11 Page 13...
  • Page 170 (Sampling Arm, Reaction plate, Washing Station and Photometer) are moved to all the different positions (random). This test can be performed in case of random problems with mechanical movements. NOTE: Please remove the sampling probe before running this test! CYANExpert 130 User Manual Rev. 01, Sept 2013...
  • Page 171 11.3.9 “M ” F ACRO ETTING OLDER This folder is only used during production and quality control to read the macro present in the CYANExpert 130. 11.3.10 “C ” F ONFIGURATION OLDER This folder can only be accessed by a qualified service engineer. It is necessary to insert a password to access this folder.
  • Page 172 • In covered and dry places • Runs clinical chemistry and turbidimetric tests • Temperature: 18°C – 32°C • Large choice of Cypress Diagnostics reagents available • Relative humidity: 20 %-85 % • Up to 300 clinical applications programmable • Stable surface (no vibrations) •...

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