Diesse VES-MATIC 20 Instruction Manual
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Diesse VES-MATIC 20 Instruction Manual

Automatic instrument for the determination of the erythrocyte sedimentation rate esr
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VES-MATIC 20
INSTRUCTIONS MANUAL
Software Release N°1.33
Rev. 2.0 issued on February 2016
Automatic instrument for the determination
of the Erythrocyte Sedimentation Rate (ESR)
(Patented)
For In Vitro Diagnostic use only

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  • Page 1 VES-MATIC 20 INSTRUCTIONS MANUAL Software Release N°1.33 Rev. 2.0 issued on February 2016 Automatic instrument for the determination of the Erythrocyte Sedimentation Rate (ESR) (Patented) For In Vitro Diagnostic use only...
  • Page 2 The information contained in this manual may be subject to modifications without notice. No page in this manual may be reproduced in any form or by any means, neither electronic nor mechanical, for any use whatsoever without prior written permission from DIESSE Diagnostica Senese S.p.A. 2/59...
  • Page 3 Added Intended Use & removed CE 20 PLUS Updated attachment A of 04/15 1.33 of 05/07 Updated chapter 1, changed attachments and complete restyling. MODELS This manual applies to the following VES-MATIC 20 models: DIESSE Code Description 10334/CE VES-MATIC 20 Rev.2.0 of 02/2016...
  • Page 4 Instructions Manual SYMBOLS Legend of graphic symbols used on the instrument. Instrument satisfying requirements of European directive on in vitro diagnostic medical devices (98/79/EC). In Vitro Diagnostic medical device. Date of manufacturing of the unit. Serial number of the unit. Manufacturer.
  • Page 5 Instructions Manual GENERAL WARNINGS Before installation and use of the instrument, for ensuring correct and safe use, it is recommended to carefully read the warnings and instructions contained in this instruction manual. It is important for this instruction manual always to be stored together with the instrument for future consultation.

  • Page 6: Table Of Contents

    Instructions Manual CONTENTS CHAPTER 1 ....................................8 INTENDED USE OF THE INSTRUMENT ......................... 8 PRESENTATION OF THE INSTRUMENT ........................8 GENERAL DESCRIPTION OF THE INSTRUMENT ....................... 10 MATERIAL SUPPLIED WITH THE INSTRUMENT ......................11 LIST OF MATERIAL REQUIRED BUT NOT PROVIDED ....................11 TECHNICAL SPECIFICATIONS .............................
  • Page 7 Instructions Manual CHAPTER 7 ....................................47 EXTERNAL BARCODE READER ..........................47 GENERAL CONNECTION SPECIFICATIONS ........................47 CONNECTING UP TO A HOST COMPUTER ......................... 47 GENERAL SPECIFICATIONS FOR THE RS232C SERIAL CONNECTION ..............48 GENERAL SPECIFICATIONS FOR THE RS485 SERIAL CONNECTION ................. 48 SPECIFICATIONS OF THE ASYNCHRONOUS SERIAL COMMUNICATION PROTOCOL...........

  • Page 8: Chapter 1

    The analysis is performed in complete automation (mixing and reading) and the results are comparable 1-10 with those obtained with the Westergren method VES-MATIC 20 allows for obtaining results equivalent to those of the Westergren method (1 hour) in only 25 minutes, and equivalent to the Westergren method (2 hour) in only 45 minutes, including the mixing of the sample.
  • Page 9 Instructions Manual The instrument is designed with the temperature correction always activated and relates the results to a temperature of 18°C according to Manley’s Nomogram However, it is possible to de-select the temperature correction for individual laboratory needs. Clinical concept of the ESR The Erythrocyte Sedimentation Rate test (ESR) is performed measuring the distance travelled by red cells in autologous plasma over a fixed period of time.

  • Page 10: General Description Of The Instrument

    According to the scientific literature, normally ESR values are between 1 and 10 mm/h for males and between 1 and 15 mm/h for females; in pathological conditions they can increase to values of up to 100 mm/h and above. Approximate normal range of VES-MATIC 20 instrument: MALES...

  • Page 11: Material Supplied With The Instrument

    13. RS485 connector 14. Forced air fan Fig. 1.2.2 Rear view MATERIAL SUPPLIED WITH THE INSTRUMENT VES-MATIC 20 is supplied with the following material:  Instruction manual (CD) [Order Code: P30650010]  2x1.0A T fuses (5x20mm) [Order Code: P20400000] ...

  • Page 12: Technical Specifications

    Instructions Manual TECHNICAL SPECIFICATIONS Power supply from 90 to 264 VAC (50 / 60 Hz) Power consumption 65 W max Fuses 2 x 1.0A T (5 x 20 mm) Dimensions 490 x 330 x 365 mm ( L x H x W ) Weight 12 Kg Ambient temperature...

  • Page 13: Block Diagram

    Instructions Manual BLOCK DIAGRAM (Detailed diagrams are contained in the Assistance Manual) Fig.1.6.1 Block diagram – VES-MATIC 20 Legend: 1. C.P.U. board Keyboard 2. Motor Driver board 10. Printer interface 3. Power supply 11. Printer 4. Motor unit 12. Micro-switch door 5.

  • Page 14: Information Regarding Disposal

    COPPER EPOXY RESINS and SILICON PLASTIC MATERIALS VES-MATIC 20 instrument is operated by mains voltage, therefore has been classified as Electrical- Electronic Equipment according to the European Directive 2012/19/UE dated July 04 2012, and subsequent amendments. At the end of its life cycle, the instrument must be treated as separate collection, potentially infected, waste and eliminated according to law.

  • Page 15: Chapter 2

    Instructions Manual CHAPTER 2 STORAGE AND TRANSPORT VES-MATIC 20 is a precision instrument and must be treated as such. Inappropriate operations could damage the internal opto-electronic components and cause mechanical damage. In view of the overall dimensions and weight of the machine, the transport must be carried out manually by taking all necessary precautions in order to avoid impact or excessive tipping over that could damage the instrument.

  • Page 16: Unpacking

    Instructions Manual The power supply system (installation category II), must be “compatible” with the voltage and current specifications indicated on the nameplate attached at the back side of the instrument; and it is recommended checking the efficiency of the electrical system periodically.

  • Page 17: Positioning

    (rear panel 20 cm from the wall, front panel free, left and right side panels 10 cm space). 20 CM Fig. 2.4.1 Positioning of VES-MATIC 20 Rev.2.0 of 02/2016 17/59...

  • Page 18: Installation

    INSTALLATION The installation must be performed by an authorised DIESSE Diagnostica Senese S.p.A. technician as confirmed by the Installation Report. a. Place the instrument on a solid surface as described in the previous paragraph.

  • Page 19: Shutting Down And Shipping

    The use of other types of materials may seriously compromise the performance of this instrument. DIESSE Spa declines all liability for the performance of the instrument in case of use of other materials. All the ESR cuvettes are disposable and must not be reused.

  • Page 20: Chapter 3

    Instructions Manual CHAPTER 3 TURNING ON THE INSTRUMENT Turning on After the installation of the instrument as indicated in Chapter 2, make sure that the lid is closed and turn the power supply switch (located to the left of the power supply cable at the back side of the instrument) to the ON position «...

  • Page 21: Keyboard

    KEYBOARD Fig.3.2.1 VES-MATIC 20 is fitted with a keyboard with twelve bifunctional keys. The function of each key is only activated when the corresponding key is pressed in and released. During the manual introduction of the identification number and during the date and time updating procedure the bifunctional keys automatically provide the following numeric values: Rev.2.0 of 02/2016...

  • Page 22: Main Menu

    Instructions Manual Numeric Function value From the Select Function Menu, carry out the Line Feed of the printer. From the Select Function Menu, recall the Main Menu of the instrument (it contains the exams that can be performed by the instrument, the configuration set-up and the database with the stored exams).

  • Page 23: Description Of The Exams

    Instructions Manual The main menu contains: 4 types of analysis that can be performed by VES-MATIC 20 : ANALYSIS - ESR F1 ANALYSIS - ESR F2 ANALYSIS - ESR KINETICS F1 ANALYSIS - ESR KINETICS F2 the archive of the results of the last 3 analyses completed by the instrument in chronological order: ANALYSIS –...

  • Page 24: Esr F1 (Erythrocyte Sedimentation Rate 1H) Analysis

    Instructions Manual 3.4.1 ESR F1 (Erythrocyte Sedimentation Rate 1h) ANALYSIS ANALYSIS ESR F1 Fig.3.4.2 Gives the results in accordance with the Westergren method with the reading at one hour; the overall duration of the analysis is 25 minutes. Description of the examination cycle: At the beginning of the analysis the unit carries out a cuvette recognition cycle.

  • Page 25: Esr Kinectis F1 (Erythrocyte Sedimentation Rate 1H) Analysis

    Instructions Manual operator, and if the printing function has been previously activated, prints out the list of the cuvettes with unsuitable blood levels. 20 minutes from the end of the cycle an additional reading is made. At 0 minutes the unit makes the last reading and gives the results according to the set mode. 3.4.3 ESR KINECTIS F1 (Erythrocyte Sedimentation Rate 1h) ANALYSIS ANALYSIS ESR KINETICS F1...

  • Page 26: Displaying (And Printing) Of The Stored Analyses

    Instructions Manual Next, the instrument translates the plate to 90° for mixing of the samples according to the time and speed parameters that have been set. At the end of the mixing the first reference reading is made. 40 minutes from the end of the cycle a second reference reading is made. The highest value between the two reference readings is considered as valid.

  • Page 27: Param. Setting Set-Up

    Instructions Manual Press to return to the Select Function. Fig. 3.5.4 Printout example PARAM. SETTING SET-UP The Param.Setting set-up gives a list of functions, described below, which are useful for the various operations of the systems. To gain access to this menu, select the item "SETUP-PARAM.SETTING" from the main menu, and confirm the item by pressing the OK key.

  • Page 28: Temperature Correction

    Instructions Manual 3.6.1 TEMPERATURE CORRECTION Normally the instrument determines the value of the erythrocyte sedimentation rate (ESR) and indicates the results at room temperature. Nevertheless, it may be programmed to show the results at a temperature of 18°C. The transformation takes place according to the Manley Nomogram It is recommended to apply this function in laboratories where the room temperature is well above 18°C.

  • Page 29: Printer Set-Up

    Instructions Manual 3.6.3 PRINTER SET-UP To disable the printer due to technical problems with the printer itself, or if it is considered sufficient to have the results appear on the display without being printed, proceed as follows: select the item “Setup -Param. Setting” from the Main menu and confirm with the OK key. use the ...

  • Page 30: Quality Control Set-Up

    The set status remains active until modified again. QUALITY CONTROL SET-UP With VES-MATIC 20 instrument it is possible to use the control blood (ESR Control – sold separately: REF 10430 and REF 10434) by activating the QC function, which represents a test for monitoring the values of the erythrocyte sedimentation rate (ESR), in order to check the analytical methods.
  • Page 31 Instructions Manual 1. Number of the ESR Control blood production lot LOT. Nr. _ _ _ _ _ _ Fig. 3.7.3 2. Production date of the ESR Control blood DATE _ _ _ _ _ _ Fig. 3.7.4 3. Min-Max values of the Sample Normal ESR Control blood NORMAL 0 0 0 Fig.

  • Page 32: Updating The Date And Time

    Instructions Manual If the data is not set the QC will be carried out with the default values 1. The set status remains active until modified again. 2. In case if the supplied values don’t comply with the expected values contact the Technical Assistance.

  • Page 33: Chapter 4

    In order to prepare the cuvettes, refer to the relative Instructions for Use. Filling the test tube For VES-MATIC 20 instrument to correctly carry out the ESR exam, check the filling of the test tube by measuring the filling value and comparing it with the pre-set tolerance values of the maximum and minimum levels.

  • Page 34: Sequence For Preparing An Exam

    Instructions Manual In case of over-filling, the instrument will print a "(sample) HIGH" error message, while in case of under- filling the instrument will print a "(sample) LOW" error message. In both cases it will be necessary to repeat the filling operation. SEQUENCE FOR PREPARING AN EXAM This procedure is not applied in case of using an external barcode or if the “manual insertion”...

  • Page 35: Resume Analysis

    Instructions Manual It is possible to abandon the analysis at any time by pressing the ESC key and then pressing the OK key. a. During the course of the analysis, the type of exam and the time left until it is finished will appear on the display.
  • Page 36 Instructions Manual POSITION : DISP TO EDIT Fig. 4.4.2 and the instrument emits an acoustic signal. press the DISP key to manually load the identification number and the following message will appear on the display: Input BARCODE: ... . . Fig.
  • Page 37 Instructions Manual 1234567890ABC POSITION: 01 Fig. 4.4.5 4. if the code is incorrect the operator can press the ESC key, the following message will appear: 1234567890ABC NEW CUVETTE? Fig. 4.4.6 by pressing the OK key you’ll return to the loading of the code by pressing the ESC key the loading procedure is cancelled and you’ll move onto the analysis.

  • Page 38: Sequence For Preparing An Exam With An External Barcode Reader

    Instructions Manual a. press the OK key if you want to continue the manual loading of the ID number b. press the ESC key to terminate the procedure; when the following message appears on the display: END LOADING? Fig. 4.4.8 close the lid and confirm with the OK key.
  • Page 39 Instructions Manual 5. The operator then proceeds with the reading of the identification number of the sample via the use of the barcode reader, and after having checked that the code has been accepted by the instrument (shown on the display), loads the cuvette into the position indicated on the display. At this point the instrument emits a prolonged acoustic signal to confirm the loading of the test tube into the correct position and moves onto the next loading position.
  • Page 40 Instructions Manual press the ESC key to terminate the procedure; when the following message appears on the display END LOADING? Fig. 4.5.6 close the lid and confirm with the OK key 10. The following request will appear at the end of the procedure: PRINT JOBLIST? Fig.

  • Page 41: Chapter 5

    Instructions Manual CHAPTER 5 GENERAL RECOMMENDATIONS VES-MATIC 20 has been designed and manufactured in a way that very little maintenance is required. For any interventions: - disconnect the instrument from the power supply, - use the personal protection equipment during operation, - do not remove the safety guards and do not ignore the safety devices.

  • Page 42: Replacement Of The Check Device

    - Close the paper-holder compartment. REPLACEMENT OF THE CHECK DEVICE VES-MATIC 20 is supplied already tested and set up for carrying out the first 4000 tests without the Check Card. After having carried out the first 4000 tests it will be necessary to insert a new Check Card into the housing.

  • Page 43: Check Of The Acoustic And Safety Devices (Microswitches)

    Instructions Manual 5.5.1 CHECK OF THE ACOUSTIC AND SAFETY DEVICES (MICROSWITCHES) Operations to be carried out with the instrument turned on: Leave the lid open and launch an analysis cycle. At this point, if the safety devices function correctly, the instrument will emit a prolonged acoustic signal and will prevent any movement of the internal mechanical parts.
  • Page 44 Instructions Manual Use a socket head screwdriver to extract the fuse box. Fig.5.6.2 Replace the damaged fuses with new ones supplied with the instrument. Fig.5.6.3 Replace the fuse box. Fig.5.6.4 (1) Reconnect the instrument to the power supply. Fig.5.6.5 Turn on the instrument again. If at the time of turning on the fuses they trip again, contact the Technical Assistance.

  • Page 45: Chapter 6

    Instructions Manual CHAPTER 6 SELF-DIAGNOSIS Besides carrying out the command and control operations of the peripherals, the C.P.U. constantly controls the most important parts of the instrument. Whenever a fault is detected the operation in progress is automatically interrupted with an acoustic signal and at the same time a message with the type of fault or trouble detected appears on the display.
  • Page 46 Instructions Manual ABSENT (Sample) Control presence cuvettes instrument. This message is printed when there is an absence Remove the fault sample and replace it with new of cuvettes or samples with a hematocrit value of with a hematocrit value >15% <...

  • Page 47: Chapter 7

    CONNECTING UP TO A HOST COMPUTER It is possible to connect VES-MATIC 20 to a Host Computer either via the RS232C serial interface (Fig. 72.1.1 - 12) or via the RS485 serial interface (Fig.7.2.1 - 13), installed on the back side of the instrument.

  • Page 48: General Specifications For The Rs232C Serial Connection

    Instructions Manual GENERAL SPECIFICATIONS FOR THE RS232C SERIAL CONNECTION Check that the connectors of the 3-wire type (Tx-Rx-Gnd), connecting cable are connected in the following manner: (Standard cable) VES CONNECTOR HOST-COMPUTER CONNECTOR DB9 Type DB9 Type DB25 TYpe GENERAL SPECIFICATIONS FOR THE RS485 SERIAL CONNECTION To connect VES-MATIC by means of the RS485 serial connection it is necessary to have the USB/485 Optional Converter Kit on hand (see attachments).

  • Page 49: Ves20/30 Serial Commands And Parameter Format

    (that is, the command ‘02’ without the control of the check sum) with the parameter ‘03’ indicating the number of the analysis that has to be received. From ’01’ to ‘04’ for VES-MATIC 20 New; from ‘01’ to ‘03’ for VES-MATIC 30 New. To request the last analysis carried out the parameter must be ‘00’.
  • Page 50 Instructions Manual N.B.: after having received each data block the host computer must send an ACK message. A header with 20 bytes is sent with information relating to : The type of analysis 1 byte [0x01=F1, 0x02=F2, 0x03=F1K, 0x04=F2K] Settings of the ESR at the time of receipt 1 byte [X X BO BE BI FP FD FT where FT= flag correction in temperature 1 is ON, FD=Flag results on the display, FP=flag results on the printer, BI=Flag internal barcode selection, BE=flag selection of external Barcode, BO=flag deselection of barcode]...
  • Page 51 Instructions Manual 0x04: Command requesting machine status The machine status consists of 2 entire hexadecimal ASCII represented respectively in two groups of 4 bytes each. The first four bytes codify the following information: Value of the bits: Code Type of analysis Type of analysis Type of analysis Reset in progress...
  • Page 52 Instructions Manual 0x05: Setting of reading register The value of the register of the settings is restored in 2 hexadecimal ASCII bytes. The bits of the register have a Boolean value (1=ON) Code Temperature correction Results on the display Results on the printer Internal Barcode External Barcode Barcode disabled...
  • Page 53 ‘ACK’ response if affirmative, otherwise ‘NACK’ 0x09: Barcode reading This carried out the reading of the barcode stored in the position requested. The positions range from 0 to 19 in case of VES-MATIC 20. Example: from Host The machine with ID ’01‘ is requested to carry out the command ‘0x89’...
  • Page 54 Instructions Manual 0x0A: Barcode writing This command allows for writing the barcode in the desired position of the analysis in progress. The positions range from 0 to 19 in case of VES-MATIC 20. Example: from Host >000F018A07ABCDEFGHILMNO+CR+00 The machine with ID ’01‘ is requested to carry out the command ‘0x8A’...

  • Page 55: Bibliography

    Blutkor- perchensenkungsgeschwindigkeit (VES-MATIC): Einsatz im Krankenhaus. Berichte der OGKC 1988; 11:112-114. 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 56: Attachment A: Ce Compliance Certificate

    Instructions Manual Attachment A: CE COMPLIANCE CERTIFICATE The current EC Declaration of Conformity is available for the download from DIESSE’s website www.diesse.it Attachment B: GUIDELINES FOR THE INSTALLATION REPORT Installation report Sequence see Paragraph Preliminary checks 2.2. Unpacking of the instrument 2.4.

  • Page 57: Attachment C: Optional " Converter Kit - Usb/485" ( Order Code: 30501150)

    Instruction Manual Attachment C: OPTIONAL “ CONVERTER KIT - USB/485” ( order code: 30501150) To connect only One instrument "VES-MATIC 20/30" with a PC, it is possible use a normal serial cable. To connect more instruments to a PC you must use connection RS485.
  • Page 58 Layout of the instruments: (responsibility of the Technical Assistance) 1. In order to use the converter kit USB/485 with an instrument of the ESR line: Set up the NEW protocol (from the FACTORY TEST for VES-MATIC 20 or from the SET-UP SERVICE for VES-MATIC 30)

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