1. Manuals
  2. Brands
  3. Diesse Manuals
  4. Laboratory Equipment
  5. CHORUS EVO
  6. User manual

Diesse CHORUS EVO User Manual

Hide thumbs Also See for CHORUS EVO:
Table of Contents

Advertisement

Quick Links

Download this manual
USER MANUAL
Rev. 1.1 – November 2024
Bench top immunometric testing platform, with ready-to-use single devices
and multiparametric testing capabilities
SOFTWARE VERSION 1.xx.xx
CHORUS EVO (REF. 82000)
ONLY FOR IN VITRO DIAGNOSTIC USE

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the CHORUS EVO and is the answer not in the manual?

Questions and answers

Related Manuals for Diesse CHORUS EVO

Summary of Contents for Diesse CHORUS EVO

  • Page 1 USER MANUAL Rev. 1.1 – November 2024 Bench top immunometric testing platform, with ready-to-use single devices and multiparametric testing capabilities SOFTWARE VERSION 1.xx.xx CHORUS EVO (REF. 82000) ONLY FOR IN VITRO DIAGNOSTIC USE...
  • Page 2 CHORUS EVO models: This manual applies to the following models of CHORUS EVO. Catalogue number Description 82000 CHORUS EVO Accessories: Catalogue number Description 83606 WASHING BUFFER 86004 WASHING BUFFER AUTOIMMUNITY 83609 CLEANING SOLUTION 2000 83604 SANITIZING SOLUTION R30233150, R30233160 CLEANING SOLUTION TANK 2L...
  • Page 3 MANUFACTURER DIESSE DIAGNOSTICA SENESE SPA Strada dei Laghi 39, 53035 Monteriggioni (SI) Italy Phone +39 0577 307109, Fax. + 39 0577 307106 www.DIESSE.it TECHNICAL ASSISTANCE Strada dei Laghi 39, 53035 Monteriggioni (SI) Italy Phone +39 0577 307109, Fax. + 39 0577 307106...
  • Page 4 No part of this manual may be reproduced in any form or by any means, electronic, mechanical or otherwise, for any use whatsoever without the prior written permission of DIESSE DIAGNOSTICA SENESE S.p.A. Symbols: Legend of graphic symbols used in this manual Instrument meeting the requirements of the EC Directive 2017/746/EU on in vitro diagnostic medical devices.
  • Page 5 In case of sale or transfer, make sure that this manual accompanies the CHORUS EVO to allow new users to be informed about the instrument’s operation and the related warnings.
  • Page 6 The screenshots in this manual are for illustration purposes only. DIESSE is not liable for damages caused directly or indirectly by errors, faults or incidents, due to the use of manuals that do not correspond to the version of the instrument provided.
  • Page 7 BIO-CONTAMINATION HAZARDS Potentially infected material is handled. When an analysis system like the CHORUS EVO is used, all precautions must be taken regarding biological risks. The samples must be disposed of in accordance with laboratory instructions and with local laws.

  • Page 8: Table Of Contents

    COMMISSIONING THE INSTRUMENT .......................... 28 LOG IN ....................................... 28 START-UP CONTROLS ................................29 3.3.1 Washing request .................................... 29 3.3.2 Resources ......................................30 3.3.3 Motors ........................................31 3.3.4 Device loading for Hydraulic check ..........................32 3.3.5 Priming ........................................32 Rev. 1.1 CHORUS EVO USER MANUAL...
  • Page 9 Working cycle ....................................69 5.3.8 Analysis abort: ABORT ALL button ............................ 71 5.3.9 End of the analytical cycle ................................ 71 5.3.10 Conclusion of daily analytical activity ..........................71 ARCHIVE ......................................72 SETTINGS ......................................76 EXAM SCHEDULING ................................78 CHORUS EVO USER MANUAL Rev. 1.1...
  • Page 10 TROUBLESHOOTING ..................................80 SAMPLE RACK: BARCODE NOT PROPERLY RED ....................80 ERROR TABLE ....................................81 APPENDICES ......................................84 OPERATIONAL FLOW CHART - JOB LIST: DEVICE AND RESOURCE LOADING ......84 MACROARRAY TESTS ANALYTICAL EVALUATIONS ..................85 Rev. 1.1 CHORUS EVO USER MANUAL...

  • Page 11: Introduction

    DESCRIPTION OF THE INSTRUMENT The CHORUS EVO analyzer is a standalone, bench-top unit that is pre-programmed with the software required to conduct the necessary tests autonomously. Figure 1 shows the CHORUS EVO model (REF: 82000).

  • Page 12: Front Side

    Figure 1 – The instrument CHORUS EVO The high level of automation provides the CHORUS EVO analyser with a “walk-away” capability and gives the instrument the continuous loading and random-access features. The user only needs to insert the samples into the dedicated racks, place the racks in the appropriate front compartment, define the test work plan, and insert any necessary devices or missing resources (e.g.

  • Page 13: Right Side

    Right View Legend: "I" [ON]/ "O" [OFF] Switch DB9 serial connector for connection to Host (LIS) Ethernet network socket Double USB port for connection to external barcode reader, external printer, keyboard or USB keys CHORUS EVO USER MANUAL Rev. 1.1...

  • Page 14: Left Side

    The electrical connection of the instrument is positioned on the rear left side, as shown in Figure 5. Figure 5 - Rear side Rear View Legend: Power cord receptacle Fuses Cooling fans 1.4.5 Technical components Rev. 1.1 CHORUS EVO USER MANUAL...
  • Page 15 SAMPLING UNIT • Unit responsible for the transfer of the samples from the test tubes in the rack to the device strips inside the preload rotor and for the sample dilution in the precycle CHORUS EVO USER MANUAL Rev. 1.1...

  • Page 16: Technical Data

    The unit consists of a metal needle, equipped with a crash sensor and a capacitive level search sensor. TECHNICAL DATA Figure 6 - CHORUS EVO general layout Figure 1.6.1 – CHORUS EVO general layout FIELD VALUE Europe: 230Vac@50Hz;Usa/Canada: 110-...
  • Page 17 Service camera 8MP Camera Image processor See Central Unit Interfaces 1 x RS232C, 3 Host USB, Ethernet Protection category CLASS I Safety standard EN 61010-1, EN 61010-2-101 EN61326-1, EN61326-2-6 Installation category Protection Class IP22 CHORUS EVO USER MANUAL Rev. 1.1...

  • Page 18: Instrument Label

    9. Instrument serial number DISPOSAL The CHORUS EVO instrument relies on the use of an electrical power source and therefore, in compliance with the EUROPEAN DIRECTIVE 2012/19/CE of July 04, 2012 and later amendments by the European Parliament, it is classified as Electrical-Electronic Equipment.

  • Page 19: Transport, Installation And Safety

    DIESSE DIAGNOSTICA SENESE S.p.A. Any materials and/or accessories supplied for CHORUS EVO have been specially designed and cannot be replaced with other types of materials or supplies. The instrument's performance can be severely compromised when using other types of materials and/or accessories.

  • Page 20: Electrical Hazards

    2.2.2 Electrical hazards The instrument must be powered only by the power supplies given by DIESSE DIAGNOSTICA SENESE S.p.A., contained in the packaging, and these power supplies must be connected to an electrical outlet. The power supply must meet the requirements indicated on the label.

  • Page 21: Transport And Storage

    Before connecting to external instruments (Host, PC, external barcode reader), which must always be carried out with the CHORUS EVO USER MANUAL Rev. 1.1...

  • Page 22: Positioning

    INSTALLATION must be carried out by an installation technician authorised by DIESSE DIAGNOSTICA SENESE S.p.A. as stated in the Installation Report. Please refer to the Installation Guide. DECOMMISSIONING and SHIPPING must be carried out by a technician authorised by DIESSE DIAGNOSTICA SENESE S.p.A.

  • Page 23: Materials Provided With The Instrument

    To move the instrument, always install and use the supplied handles. When handling the device, avoid excessive bumps and inclinations which could damage the instrument. MATERIALS PROVIDED WITH THE INSTRUMENT The CHORUS EVO is supplied with the following materials: User manual • •...
  • Page 24 In particular, the solution compartment of the CHORUS EVO is equipped with (see Figure 8): A connection for the Washing Buffer Autoimmunity tank • A connection for the Washing Buffer Infectious Diseases tank • • Two connections for the Cleaning solution tanks •...
  • Page 25 Figure 10 - Connection of the tanks to the internal pipes Once all tanks have been connected to the corresponding tube, they can be loaded on its vessel. Final assembly should look like Figure 11: CHORUS EVO USER MANUAL Rev. 1.1...
  • Page 26 Connect the hydraulic connection, marked with the green label, to the cap of the Washing Buffer Autoimmunity tank, also marked with the green label. During the priming cycle, the program will check the corresponding load cells to ensure correct connections. Rev. 1.1 CHORUS EVO USER MANUAL...

  • Page 27: Connecting The Discharge Tank

    (Figure 4). If a different connector is required, it is possible to order it directly from DIESSE DIAGNOSTICA SENESE S.p.A, specifying the characteristics of the connection itself.

  • Page 28: Limitations And Warnings

    Improper use and lack of or incorrect maintenance could seriously affect the analytical process. Reagents and Consumables: Any materials and/or accessories supplied for CHORUS EVO have been specially designed and cannot be replaced with other types of materials or supplies. The instrument's performance can be severely compromised when using other types of materials.

  • Page 29: Instrument Preparation

    LOG IN Only registered users can operate the CHORUS EVO. During the installation of the instrument, specialized personnel will define the following levels of grant access: Operator: Users with all the rights needed to execute the exams.

  • Page 30: Start-Up Controls

    DIESSE personnel. The list of functionalities dedicated to this level is reported in the service manual. • DIESSE QC: Users having, in addition to the Service Technician rights, the possibility to change the default setting of the machine in terms of lids control checks, maintenance setting, exam barcode validity etc.

  • Page 31: Resources

    The refilling sequence and the color code shown is the following: Green: Autoimmunity (Figure 15) • Blue: Infectivology (Figure 16) • White: Cleaning (Figure 17) • Yellow: Sanitizing (not mandatory) • Figure 15 - Initialization, check solutions weight (Autoimmunity) CHORUS EVO USER MANUAL Rev. 1.1...

  • Page 32: Motors

    18), and check that all the home positions are reached without loss in the encoders reading. If a motor is not positioned correctly, an error message is shown. If no errors occur, no interaction with the user is required. Rev. 1.1 CHORUS EVO USER MANUAL...

  • Page 33: Device Loading For Hydraulic Check

    Autoimmunity or Infectiology buffer. During this phase no action is required by the user. If the procedure is successful the user is redirected to the next phase of the initialization (paragraph 3.3.6), otherwise the procedure can be repeated. CHORUS EVO USER MANUAL Rev. 1.1...

  • Page 34: Hydraulic Checks

    Green: check passed Red: check failed • No interaction from the user is needed. In case of failure in one of the checks above, a popup will be shown, and the user may retry the procedure. Rev. 1.1 CHORUS EVO USER MANUAL...

  • Page 35: Optical Checks

    (82058) in the loading rotor (see Figure 19). During the optical check the instrument verifies the proper operations of all the components related to the CHORUS EVO reading system. The following aspects are checked: The dark noise received from the photomultiplier used in the CLIA exams is below •...

  • Page 36: Strip Recovery

    3.3.9 Thermoregulation CHORUS EVO is equipped with a Peltier system which can increase or decrease the internal temperature of the instrument depending on the exam needs. During the start- up phase, the instrument will start a thermoregulation procedure until the default temperature (usually 28 °C) is reached.

  • Page 37: Instrument Functionality After Start-Up Controls

    3.4 STRIPS, CALIBRATORS AND QUALITY CONTROL 3.4.1 Strip Exams in CHORUS EVO are performed on single-use devices, called “strips”. Each strip is identified by a barcode (code type 128) of 16 digits. The three initial digits correspond to the test identification code.

  • Page 38: Quality Control

    PLEASE NOTE: if the QC is not inserted, the analysis is performed anyway but its absence is registered in the audit system of the instrument. CLEANING AND MAINTENANCE The CHORUS EVO, based on its design, require specific maintenance. For any type of maintenance work: Disconnect the power supply of the instrument.

  • Page 39: Manual Cleaning

    (medical device class IIb IX directive 2007/47/EC reg. 15), DIESSE code 0092. o Spray Umonium Medical Spray on the medical device 3 times to wet the surface and leave to act for 15 minutes. Dry with a dry and clean Umonium wipe (DIESSE code 0091).
  • Page 40 This operation must be carried out with the instrument switched off or in idle (no operations ongoing). o If using the tank supplied with the instrument (PART R30233150, R30233160), the supplied probe must be used (Figure 25). This probe is equipped with a tube and a connector. Rev. 1.1 CHORUS EVO USER MANUAL...
  • Page 41 Before the start of a working cycle, the instrument checks the solid waste level in the containers; if it is too much to complete the current run, the user has to empty it. To carry out the emptying of the waste container, proceed as follow: CHORUS EVO USER MANUAL Rev. 1.1...

  • Page 42: Sanitization

    This cycle consists in washing, with an antibacterial solution supplied by DIESSE DIAGNOSTICA SENESE S.p.A, all parts that come into contact with the human sample (whole or diluted).
  • Page 43 Before access to the internal parts of the instrument by authorized personnel • 3.5.3.1 Automatic sanitization procedure CHORUS EVO sanitization procedure consists in: Flushing the circuit with the Sanitizing Solution • To wait 2h for the Sanitizing Solution to eliminate all the microorganisms present •...
  • Page 44 At counter timeout, the tubes will be rinsed again with the cleaning solution. After that, SW asks for the emptying of the dedicated liquid waste. The correct maintenance of the hydraulic circuit is fundamental for the good interpretation of the results of the tests performed by the instrument. Rev. 1.1 CHORUS EVO USER MANUAL...

  • Page 45: Routine Maintenance

    3.5.6 Software update The instrument software may be updated periodically by DIESSE personnel. This is important to continuously improve the instrument performance and capabilities. Moreover, a software update can be necessary in order to process newest tests designed by DIESSE.

  • Page 46: Instrument Uninstallation

    If the is the need to uninstall the instrument, follow the procedure below: o Wash the internal circuits of the instrument using the SANITIZING SOLUTION supplied by DIESSE (REF. 83604). The solution is supplied concentrated; it is therefore necessary to prepare a 2-liter tank according to the instructions in the package.

  • Page 47: Description Of The User Interface

    20. Status bar: number of tests in progress, time remaining to complete precycle, currently available positions in the pre-load rotor 21. USB safe removal) 22. ABORT ALL button 23. Strip status in pre-load and reaction rotors CHORUS EVO USER MANUAL Rev. 1.1...

  • Page 48: Command Description - Common Information

    The samples present are displayed in different colours, depending on the status of the latter: Light blue: sample ready to be processed • Green: correctly processed sample. The sample can be removed • Purple: sample aborted • White: sample not yet associated with any exam • Rev. 1.1 CHORUS EVO USER MANUAL...
  • Page 49 A drop icon is used for the liquid waste while a strip/device icon for the solid waste (Figure 35, on the left). In correspondence with full discharges, a red allert icon is CHORUS EVO USER MANUAL Rev. 1.1...
  • Page 50 Select the samples that user want to analyze, as described in paragraph 5.1 (manually or using the “Get from Host” option) Clicking on “Cancel Selection” it is possible to remove the exams associated with • a sample Rev. 1.1 CHORUS EVO USER MANUAL...
  • Page 51 The archive page is divided into 3 sections: QC, Patient Results and Calibrators. The 3 types will be selectable from the same page, that will contain the results of the archive selection made. The description of the Archive is reported in paragraph 5.4. Search button CHORUS EVO USER MANUAL Rev. 1.1...
  • Page 52 Allows, by typing the relative barcode, the search for a sample or a specific test inside the instrument or in the rack or in the instrument archive. Settings button Allows access to the instrument configuration menu. Rev. 1.1 CHORUS EVO USER MANUAL...

  • Page 53: Use Of The Instrument

    RACKS MANAGEMENT CHORUS EVO is equipped with 4 racks. There are 3 racks of type shown in Figure 37 (the 3 items on the left) to be used to host samples of the patients. Each of them can host up to 16 tubes.

  • Page 54: Warnings And Limitations

    A. 5.2.1 Warnings and limitations Cal and QC dedicated tubes provided by DIESSE should always be hosted inside the dedicated adaptor supplied with the instrument (10614300, see Figure 39). If CAL or QC samples are inserted in racks Rev.

  • Page 55: Operational Flow

    LED showing the position of the rack in the loading compartment is of the correct colour and the racks must be removed horizontally towards the operator without lifting them. 5.3.2 Preparation for work cycle and authentication CHORUS EVO USER MANUAL Rev. 1.1...

  • Page 56: Sample Loading

    Press the dedicated door unlock button to request access to the loading compartment and open the door (Figure 41). If the instrument is in idle and does not have any racks inside, the door is already unlocked and the door unlock button is disabled. Rev. 1.1 CHORUS EVO USER MANUAL...
  • Page 57 If the barcode of the sample has not been read correctly, the error will be signaled on the screen by a red dot. Moreover, if the rack reference barcodes are not red correctly the red arrow corresponding to the rack’s position will turn red (Figure 42). CHORUS EVO USER MANUAL Rev. 1.1...
  • Page 58 However this must be done only in really exceptional cases as it causes the abort of all ongoing analyses. If a rack containing a sample to be processed is removed, the following popup will appear: Rev. 1.1 CHORUS EVO USER MANUAL...

  • Page 59: Job List Definition

    Alternatively, it is possible to automatically compile the job list through the connection to the centralized system Host. In this specific case, the user does not need to perform the actions described in paragraphs 5.3.4.2 and 5.3.4.3, and the relevant paragraph is 5.3.4.4. CHORUS EVO USER MANUAL Rev. 1.1...
  • Page 60 User can do the exam search multiple tipe following the instruction above and expanding the current list at his will. Figure 46 shows a “Current list” with two different types of exams. Rev. 1.1 CHORUS EVO USER MANUAL...
  • Page 61 R1-P1 BARCODE-ID on the left and the row showing the exam id 0951 on the right. Once confirmed (by pressing the CONFIRM button), the pair Sample/Exam is shown in the summary table “Job List Summary” shown on the bottom of the page. CHORUS EVO USER MANUAL Rev. 1.1...
  • Page 62 (including calibrator, QC and additional solutions) will be asked to the user (as described in paragraph 5.3.5). Notice that by clicking on the DONE button, a first check of the resources is performed, where it is highlighted: Rev. 1.1 CHORUS EVO USER MANUAL...

  • Page 63: Job List Devices And Resource Loading

    PRINT, it is possible to print the list of scheduled tests. This function is not currently implemented on the instrument. By pressing CONTINUE on the shopping list page, user is redirected to the Device Insertion page (Paragraph 5.3.5.1). CHORUS EVO USER MANUAL Rev. 1.1...
  • Page 64 At the end of the rotation of the rotor, the automatic door will reopen to allow the user to continue with the insertion of the devices. Also the “Device list” is refreshed at this point. Rev. 1.1 CHORUS EVO USER MANUAL...
  • Page 65 In case it is necessary to insert calibrators or QC, after the insertion of the first batch of devices described in paragraph 5.3.5.1, the instrument will show the calibrators and QCs shopping list as reported in Figure 54. CHORUS EVO USER MANUAL Rev. 1.1...
  • Page 66 User can check that all the sample barcode are properly red. If not the user can insert the sample barcode manually or retry the rack insertion after having checked the correct Rev. 1.1 CHORUS EVO USER MANUAL...
  • Page 67 3.3.2. NOTICE: If during this phase some exams are already running, it is possible that the reintegration of the operating liquids and the emptying of the CHORUS EVO USER MANUAL Rev. 1.1...

  • Page 68: Special Cases And Flow Correction

    (PART R30512301). This QR-code contains relevant data which is used by the analysis algorithms to properly process the Macroarray exams. More details on the Macroarray algorithms are available in appendix. Rev. 1.1 CHORUS EVO USER MANUAL...
  • Page 69 This happens when: o Some mandatory resources are not provided, as described in 5.3.6.3 o Clicking the back button during device loading (Paragraph 5.3.5) CHORUS EVO USER MANUAL Rev. 1.1...

  • Page 70: Working Cycle

    Light blue: sample ready to be processed • White: sample not assigned • Green: correctly processed samples. The rack and all the samples can be removed • Purple: sample aborted • Rev. 1.1 CHORUS EVO USER MANUAL...
  • Page 71 Home position; at this point the operator can open the door and the automated security door will only open in correspondence with the rotor arc containing free positions in which to insert the new devices. At each additional loading, the scheduling CHORUS EVO USER MANUAL Rev. 1.1...

  • Page 72: Analysis Abort: Abort All Button

    In case of any error occurring during the analysis cycle or during the elaboration of the results, a popup is shown in foreground describing the error ID (see section 6.2), the sample and the strip affected. 5.3.10 Conclusion of daily analytical activity Rev. 1.1 CHORUS EVO USER MANUAL...

  • Page 73: Archive

    NOTICE: Before turning off the instrument's main switch, ALWAYS press the STOP button. ARCHIVE Archive can be accessed anytime by clicking ON the icon displayed at the bottom part of the screen: CHORUS EVO USER MANUAL Rev. 1.1...
  • Page 74 Figure 65 - Generic archive page In the future, result searches will also be possible by clicking on the appropriate icon located at the bottom of the main screen. Currently, this feature is not yet implemented. Rev. 1.1 CHORUS EVO USER MANUAL...
  • Page 75 For the operation to be successful, the LIS network cable must have been previously connected to the instrument's serial port (Paragraph 1.4.2). When the button is pressed, the user is prompted to confirm the action via a pop-up (Figure 67). CHORUS EVO USER MANUAL Rev. 1.1...
  • Page 76 Figure 69 - Recalculated results in the archive Pressing EXPORT ARCHIVE will display the following message (Figure 70) if the USB drive is incompatible (or if the USB drive is not properly inserted into the designated slots; see Paragraph 1.4.2): Rev. 1.1 CHORUS EVO USER MANUAL...

  • Page 77: Settings

    (see section 3.2). Settings relevant for service or technical operators are reported in the service manual. To access the setting page user must press the button on the home page: The following page will be displayed (Figure 72): Figure 72 - Settings Menu CHORUS EVO USER MANUAL Rev. 1.1...
  • Page 78 Operator or Administrator type. For each new user created, a validity period for the profile can be set. Additionally, the Administrator can disable profiles that are no longer needed. Rev. 1.1 CHORUS EVO USER MANUAL...

  • Page 79: Exam Scheduling

    EXAM SCHEDULING CHORUS EVO is a “continuous loading” instrument which means that, providing the loading rotor has enough free slots, exams can be programmed anytime by the user. The instrument uses a scheduling algorithm to efficiently process the exams with the criteria reported below (in this order of importance): •...
  • Page 80 Furthermore, the instrument will not allow the loading of samples whose strips would remain in the preloading rotor for more than five hours, potentially causing degradation of the kit. The user will be notified via a pop-up. Rev. 1.1 CHORUS EVO USER MANUAL...

  • Page 81: Troubleshooting

    Once removed the GUI shows a yellow arrow suggesting that user can insert again the rack (Figure 78): Figure 78 - Possible to insert again the rack If the rack is properly red the GUI will show a green arrow (Figure 79): CHORUS EVO USER MANUAL Rev. 1.1...

  • Page 82: Error Table

    Problem with analyzing the raw data file. Export the LOG, Archive, and contact Technical Support Invalid calibrator Check the correct entry of the calibrator barcode. If the error occurs again, restart the instrument and scan the calibrator again. If the problem Rev. 1.1 CHORUS EVO USER MANUAL...
  • Page 83 Make sure the QR code is positioned correctly so code of the Macroarray that it can be scanned by the external barcode reader. If the problem persists, export the LOG, Archive, and contact Technical Support CHORUS EVO USER MANUAL Rev. 1.1...
  • Page 84 11006 Weekly maintenance The user has not performed the weekly cleaning not performed of the instrument. It is strongly recommended to carry cleaning procedures whenever requested by the instrument Rev. 1.1 CHORUS EVO USER MANUAL...

  • Page 85: Appendices

    RESOURCE LOADING The following flow chart show the operations needed to run a new job list, as described in section 3.3.5 (Figure 80, Figure 81): Figure 80 - Resource loading (solutions and CAL/QC) flowchart CHORUS EVO USER MANUAL Rev. 1.1...

  • Page 86: Macroarray Tests Analytical Evaluations

    In particular, the parameter name is reported under the “Test” Column. Rev. 1.1 CHORUS EVO USER MANUAL...

This manual is also suitable for:

82000

Table of Contents