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Diesse VES MATIC Original User Manual

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USER MANUAL
Rev. 1.0 – September, 2022
Automated instrument for ESR determination
with modified Westergren method
Software version 1.xx.xx
For in vitro diagnostic use only
Rev. 1.0 (09.2022)
VES MATIC Original
|
USER MANUAL USER
1

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Summary of Contents for Diesse VES MATIC Original

  • Page 1 USER MANUAL Rev. 1.0 – September, 2022 Automated instrument for ESR determination with modified Westergren method Software version 1.xx.xx For in vitro diagnostic use only Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 2 This page is intentionally left blank. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 3 VES MATIC Original models: This manual is applicable to the following VES MATIC Original instrument models: Catalogue number Description 10340 VES MATIC Original VES MATIC Original Accessories: Catalogue number Description 10270 TEST DEVICE ORIGINAL 4K (4000 tests) 10430 ESR Control (4x9 mL)
  • Page 4 Manual revisions list: Description REV. User manual 1.0 – September, 2022 First issue Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 5 MANUFACTURER DIESSE DIAGNOSTICA SENESE S.p.A. Strada dei Laghi 39, 53035 Monteriggioni (SI) Italy Tel. +39 0577 307109, Fax. + 39 0577 307106 WWW.DIESSE.IT TECHNICAL SUPPORT Strada dei Laghi 39, 53035 Monteriggioni (SI) Italy Tel. +39 0577 307109, Fax. +39 0577 307106...
  • Page 6 CAUTION: potential risk of damage to the instrument; all the conditions indicated in the relative text must be read and understood before proceeding. N.B. important information. BIOHAZARD: risk of contamination with potentially infected substances. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 7 In the event of biological material leakage during the operating cycle, clean the external surfaces of the instrument with personal protective equipment and follow the decontamination rules. All supplied materials must be disposed of in compliance with the local laws. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 8: Table Of Contents

    Materials Provided ............................. 23 Unpacking the Instrument ........................24 Operating Environment ........................25 Installation Procedure ..........................26 Disposal ................................26 Fuse replacement ............................27 Procedure for replacing the printer paper ................28 Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 9 10 CONNECTION TO HOST COMPUTER ......................73 PERFORMANCES ................................74 11.1 Precision of VES MATIC Original ....................... 74 11.2 Correlation of VES MATIC Original and Westergren reference method ....78 BIBLIOGRAPHY ................................85 Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 10: Introduction

    The instrument is to be used only by professional laboratory users. Instrument overview The VES MATIC Original (Figure 1) is an instrument designed to measure the quantitative Erythrocyte Sedimentation Rate (ESR) with the modified Westergren method using venous whole blood anticoagulated in citrate (Ref. 1,14-18). The instrument allows up to 30 blood samples to be analysed in random access and continuous loading mode.
  • Page 11 2-hour Westergren method in only 60 minutes. (Ref. 1-10). The maximum analytical output of the system is 60 results/hour. Figure 1 – VES MATIC Original The instrument, programmed to always work with the temperature correction activated, reports results at a temperature of 18°C according to Manley's nomogram (Figure 2).

  • Page 12: Clinical Significance Of Esr

    “acute phase proteins”, the binding of these proteins (fibrinogen, immunoglobulins) with the surface of the red blood cells alters the negative membrane charge (Z-potential) and these can stack up to form so-called rouleaux. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 13: Normal Esr Values (Westergren Citrated)

    <60 mm / hr) and high (ESR> 60 mm/hr) (Ref. 14-18) regardless of gender and age. The scientific literature indicates that the normal ESR value for ages under 50 is between 1 Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 14: Material Required For Using The Instrument

    In the VES MATIC Original, these samples may be undetected or yield varying results; for this reason, a visual inspection of the sample to verify the presence of a clear interface between the plasma and sedimented cells at the conclusion of the test is recommended.

  • Page 15: Personal Protective Equipment (Ppe)

    Safety glasses ▪ Lab coat ▪ Ordinary maintenance The VES MATIC Original has been designed and built to require minimal maintenance. Before any maintenance works: • Turn off the instrument and disconnect it from the power supply • Use suitable personal protective equipment (paragraph 1.7) during...
  • Page 16 For assistance with the inside of the instrument not easily accessible to the operator, contact Technical Services. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 17: Technical Data

    2 TECHNICAL DATA Technical description Figure 3 - Instrument Layout The VES MATIC Original consists of a single body containing all the operating functions necessary for analysing the sample. Test Tube Plate The instrument is fitted with a 3D-printed test tube plate with 30 slots arranged in two concentric circles of 15 positions each that allow accommodating the samples.

  • Page 18: External Connections Of The Instrument

    The power connector is on the back of the instrument (Figure 4). Figure 4 - Power connector The “I “ [ON] / “O” [OFF] switch is on the left side of the instrument base (Figure Figure 5 - Power button Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 19: Software Update

    Figure 6 – Connectors for external supports 2.3 Software Update Software updating is a simple, direct procedure: • Download the software from www.diesse.it • Save the contents of the “VM_Original_version_number” folder in a USB memory device. Note: depending on the update, the folder "VM_Original_version_number" may contain: a.

  • Page 20: Technical Features

    ARM Cortex-M4 180 MHz Microprocessor DISPLAY 10.1” vertical, wide OPTICAL UNIT 2 pairs of optical elements INTERFACES USB Host; USB Client; 2x RS232 PROTECTION CLASS SAFETY STANDARDS EN 61010-1; EN 61010-2-101 EN 61326-1/EN 61326-2-6 Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 21: Instrument Composition

    Cadmium Tantalum Others (No Latex) 2.6 Units of Measurement The units of measurement are expressed according to the INTERNATIONAL MEASURING SYSTEM as indicated in the technical standard CEI EN ISO 80000-1:2013. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 22: Instrument Label

    6. Specification of maximum power consumption and characteristics of protection fuses at instrument input 7. Serial number of the instrument consisting of the year, month, and day of production and progressive number Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 23: Installation

    3 INSTALLATION The VES MATIC Original is a precision instrument and must be handled as such. Inappropriate operations may damage the internal optoelectronic components and cause mechanical damage. Follow the instructions in this chapter to ensure the safety of the instrument and the operator.

  • Page 24: Unpacking The Instrument

    Open the box from the top. Figure 10 - Unpacking the instrument: opening the box Remove the block of polyethylene foam covering the instrument. Remove the accessories stored inside. Remove the instrument from the box. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 25: Operating Environment

    The safety of the instrument and the operator is not guaranteed if one or more of the following conditions are not met: • The mains must be compatible with the voltage and current specifications indicated on the metal plate affixed to the rear of the instrument. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 26: Installation Procedure

    UNPLUG THE POWER CABLE. 3.7 Disposal The VES MATIC Original, to be functional, 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 27: Fuse Replacement

    Figure 17 – Fuse replacement: repositioning the fuse box 5. Reconnect the instrument to the power supply. 6. Turn the instrument back on. If the problem persists after completing the fuse replacement, contact Technical Service. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 28: Procedure For Replacing The Printer Paper

    3.9 Procedure for replacing the printer paper The following section describes the correct procedure for replacing the paper roll in the thermal printer integrated into the VES MATIC Original instrument. When red lines appear on the printed document, the paper roll needs to be replaced.
  • Page 29 The incorrect positioning of the black bar (Figure 19 and Figure 18) would compromise the normal functioning of the printing procedure. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 30: Use

    2. The test can be performed if the total volume, including citrate and blood, is between 1.0 ml and 1.6 ml inside the tubes (ESR-TEC or VACU-TEC). 3. When using the VES MATIC Original system in the random access mode, it is recommended to mix the samples before starting the test.
  • Page 31 In order for the barcodes of the tubes to be read by the internal barcode reader, insert the test tube into the instrument so that the label is positioned opposite the mark on Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 32: Home Page

    4.3 Home page Turn on the VES MATIC Original with the switch on the left side of the instrument. When the instrument is turned on, the LEDs around the screen will activate. Initially, the colours will follow one another then each colour will have its meaning to help the user understand the instrument's condition even from a distance.
  • Page 33 Instrument logo: it displays the instrument logo identifying the trade name. • Info: this button allows the user to display the instrument Help, i.e. a short, interactive guide on how to use the instrument. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 34: Start - Performing An Analysis Cycle

    ARCHIVE: Allows the user to consult the data contained in the archives; • SETTINGS: Allows the user to change instrument settings. START - Performing an analysis cycle Click START to enter the analysis mode (Plate view). Figure 26 – Plate view Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 35 “PRINT”: prints, upon confirmation, the results of the last cycle. If the instrument is switched on or restarted for the first time, selecting this function does not result in any operation. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 36: Inserting The Test Tubes

    (red circle in Figure 27). Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 37: Starting The Analysis Cycle

    If the barcode reading is not successful, a black dot is shown next to the sample (Figure 29). At the end of the barcode reading cycle (Figure 28), a timed window will Figure 1 display the unread positions (Figure 30). Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 38 (180°), interspersed with a 90° rotation half-way through the process, so as to thoroughly homogenise the samples (Figure 32). During this phase, a progress bar will display the time remaining until the end of the operation. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 39 (Figure 33). With reference to Figure 33, the two positions of the black and white circle represent two Quality Controls, respectively, Pathological (Abnormal) QC and Normal QC (Normal). Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 40 “Plate View”. If the 1-hour (1H) Westergren analysis mode is selected, the instrument will take a single sedimentation reading after 30 minutes. In the case of the 2-hour (2H) Westergren Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 41: Inserting A New Sample (Random Access)

    In this case, it is recommended to thoroughly mix the sample by complete inversion of the tube performed at least 12 times before inserting it into the instrument. The VES MATIC Original does not perform mixing for samples which are added in random-access mode.
  • Page 42 Information concerning the time remaining until the end of the analysis of the initial samples is always displayed in the tube view (Figure 38). Figure 38 – Timer update after adding a sample Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 43: Results

    After the test, the instrument displays the results for each sample in mm/hr (Figure 40 and Figure 41), according to the 1- or 2-hour Westergren method (W) (default setting). Simultaneously, the instrument provides an automatic printout and sends the results to the LIS (if applicable). Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 44 ESR testing. To view the detail of the error (Figure 42) or, more generally, the details of the sample (Figure 43), simply press the circle identifying the sample. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 45: Guided Reading Of The Results Printout

    At the beginning of the printout is the header, followed by the results. The order and information included in the printout are as follows: • Name of the manufacturer (DIESSE diagnostica senese); • Name of the instrument (VES Matic Original); • The software release (V 1.00.00); • The serial number of the instrument (SN 2021-05-1271);...
  • Page 46 • The range of acceptability (MIN/MAX); • The outcome of the test carried out on the control sample (FAIL/PASS); DIESSE Diagnostica senese VES Matic Original - V 1.00.00 SN 2021 – 05 – 1271 R&D STRUMENTI Date/Time 12/05/2022 14:28 Cycle Temperature: 25.4°C...
  • Page 47 The ESR result for 1-hour Westergren (1H) and 2-hour Westergren (2H), respectively, with the indication of the reference method (W/P); • The Katz index (KI) calculated in the case of the 2-hour Westergren analysis mode; Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 48: Interruption Of A Work Session

    4.4.6 Interruption of a work session In the VES MATIC Original, it is possible to interrupt the work cycle at any time by pressing the ‘STOP’ button If the interruption is confirmed (Figure 46), the relevant red status string “Cycle xx...

  • Page 49: Archive

    Position occupied in the sample holding plate between []; • ESR value (mm/h) for 1-hour Westergren (1H) and 2-hour Westergren (2H), respectively. The reference method is displayed in square brackets: W for Westergreen, P for Pachenkov. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 50: Sample Archive Functionality

    (Figure 49). It is also possible to search for the desired sample using the white box of the 'SEARCH' function (red box in Figure 49). Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 51 (Figure 50). By pressing and holding down a single line, it is possible to see the detail of the sample (Figure 53). Figure 50 - Filtered samples Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 52: Samples Selection

    The information and operations described above can be accessed in the filtered archive. 5.1.2 Samples selection Pressing on a sample row allows it to be selected: each selected row will have all fields coloured blue (Figure 52). Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 53 Print the results of the selected samples; • Permanently delete the selected samples. By pressing and holding down a sample string, it is possible to access the relevant detailed information (Figure 53). Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 54 When the 'BACK' button is pressed, confirmation of the record change is requested. • HCT, haematocrit value. The VES MATIC Original corrects the ESR value based on the haematocrit value, when present, according to the Fabry formula (correction limited to values of 15% < HCT < 40%).
  • Page 55 Archive screen, allows the user to view the QC Archive page in which the results of the quality controls are displayed (see Chapter 7). Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 56: Settings

    ➢ LANGUAGE: allows the user to select the language from those available in the drop-down menu that appears by pressing and holding down the language string. The languages that can be set on VES MATIC Original are: ENG (English), ITA (Italian), DT (German), ES (Spanish), FR (French), PT (Portuguese).
  • Page 57 ➢ TEMPERATURE CORRECTION: allows the user to enable or disable temperature correction of ESR values. ➢ QC DIESSE DECODE: disables automatic decoding of the DIESSE quality control barcode. With this setting disabled, DIESSE controls are handled as normal samples; for their recognition, the controls must be registered using the procedure described in 7.1.
  • Page 58 Figure 55 - Test Device Original 4K To refill the number of executable tests, insert the "Test Device Original 4K" tube in the appropriate slot and follow the instructions that appear on the screen (Figure 56) Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 59 On the right is the numeric keypad for entering the access code (Figure 57). Figure 57 - Service Access to the service menu is only available to personnel authorised by DIESSE Diagnostica Senese S.p.A.; please refer to the Service Manual for full details on access and service functions.

  • Page 60: Quality Control

    7 QUALITY CONTROL The Quality Controls provided by DIESSE Diagnostica Senese are automatically identified by the instrument, so there is no need to perform the registration procedure. QC registration procedure If a quality control not supplied by DIESSE is used: Apply the dedicated barcode labels;...
  • Page 61 4.2. Figure 59 shows, as an example, the correct labelling of QCs. Figure 59 – Correct labelling of QC tubes When performing an analysis cycle, the VES MATIC Original will read the barcode and automatically recognise the tube as QC, displaying it on the screen (Figure 60).

  • Page 62: Qc Archive

    (N in the case of Normal CQ or A in the case of Pathological CQ), position in the sample holder plate and ESR result for 1-hour (1H) Westergren analysis only. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 63 ESR analysis result for 1-hour (1H) Westergren analysis only, the graph of sedimentation kinetics and directional arrows to browse the detail of the previous or next sample without returning to the main page of the QC archive. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 64 By selecting the 'EXPORT' button, it is possible to print the QC. By pressing the 'Graph' button, the user accesses the "QC History" page, where the QC data are displayed in a Levey-Jennings graph (Figure 64). Figure - QC History Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 65 By pressing the “EXPORT” button , it is possible to: • Print QC data, such as QC details, mean, standard deviation, CV%, date, time and result of each analysis (Figure 65); • Filter by lot. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 66 DIESSE Diagnostica senese VES Matic Original - V 1.00.00 SN 2021 – 05 – 1271 R&D STRUMENTI __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ QC TYPE: NORMAL NAME: DIESSE_QC LOT N.: EXP DATE:...

  • Page 67: User Management

    After the logout confirmation, the user is directed to the login page. The same page is displayed to the user each time the instrument is switched on (Figure 67). All registered users are displayed on this page. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 68 If the password is correct, the user can access the home screen; otherwise, the error is notified with the message “Wrong Access Code”, and the login screen is displayed again (Figure 67). Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 69 If the logged-in user is different from the Administrator (Figure 69), the 'Settings' button will not be displayed on the home screen because he/she is not allowed to use the functions it contains. Figure 69 - User home page Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 70: Troubleshooting

    (11) the analysis position Check for any additional Failed control Failure to confirm labels and position the method control method tube as described in Chapter 4 Err (13), Err (14) Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 71: Temperature Out Of Range

    If the working temperature of the instrument does not comply with the 15°C-35°C limits set in the technical characteristics (see paragraph 2.4), this condition is signalled to the operator as soon as the corresponding key is pressed to start an analysis cycle (Figure 70). Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 72 At the end of the analysis, for the samples analysed in this condition, the ESR value is again followed by the "!" in the print report and in the archive. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 73: Connection To Host Computer

    PC to establish communication with the VES MATIC Original through a virtual COM port on USB. The “HOST BY USBD” parameter must be set to ON in the VES MATIC Original service menu. 2. Using a serial RS232 COM port on the PC: Connect a standard straight serial cable between the PC’s RS232 COM port and...

  • Page 74: Performances

    VES MATIC Original instrument (REF 10340). Test protocol Two levels of DIESSE ESR-Control (Level 1-Normal and Level 2- Abnormal) are used to assess precision. Intra-assay precision (Repeatability): the analysis must be performed on a single day by one operator and on a single instrument.
  • Page 75 ESR Value Operator 1 Day 4_ Day 5_ Replicate 1_run 1_run 2_run 3_run 4_ run run 1 run 2 run 2 run 2 run 1 Prototype 2_1585 Prototype 3_1274 Prototype 4_1654 Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 76 Day 1_ Day 1_ Replicate 2_ run 3_ run 3_ run 5_ run 5_ run run 1 run 2 run 1 run 1 run 2 Prototype 2_1585 Prototype 3_1274 Prototype 4_1654 Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 77 CV values are obtained in all precision evaluations. Furthermore, the use of three different VES MATIC Original instruments and two operators over several days ensures that the ESR measurement is not affected by instrument performance.

  • Page 78: Correlation Of Ves Matic Original And Westergren Reference Method

    11.2 Correlation of VES MATIC Original and Westergren reference method Purpose The study was conducted to assess the precision, i.e. the correlation of the automated VES MATIC Original system to the Westergren reference method. Test protocol Analysing the blood samples contained in the VACU-TEC tubes with the ESR MATIC Original in 'second hour' (2H) mode and perform the manual Westergren method for each sample.
  • Page 79 Pearson’s Correlation Coefficient r: Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 80 Determination Coefficient R Second hour Spearman’s Correlation Coefficient and Passing and Bablok regression: Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 81 Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 82 Pearson’s Correlation Coefficient: Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 83 Westergren manual benchmark method. The data obtained show that the VES MATIC Original instrument can be used instead of the Westergren method in ESR determination using DIESSE tubes.
  • Page 84 The results obtained show a high correlation between the VES MATIC Original instrument and the Standard Westergren method. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

  • Page 85: Bibliography

    Blutkorperchensenkungsgeschwindigkeit (VES-MATIC): Einsatz im Krankenhaus. Berichte der OGKC 1988; 11:112-114. 6. Vatlet M., Brasseur M., Poplier M. et al.: Evaluation of the DIESSE VES-MATIC for the Automated Determination of the Erythrocyte Sedimentation Rate (ESR). Belgian Hematological Society Meeting 1989, Abstract.
  • Page 86 Approved standard, 5 ed. CLSI document H02-A5; 2011. 26. Clinical and Laboratory Standard Institute (CLSI): Defining, establishing and verifying reference intervals in clinical laboratory; approved guideline, 3 ed CLSI document EP28-A3C; 2010. Rev. 1.0 (09.2022) VES MATIC Original USER MANUAL USER...
  • Page 87 Rev 1.0 (09.2022) VES MATIC Original USER MANUAL USER...

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