Diesse VES-MATIC CUBE 30 Instruction Manual
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Diesse VES-MATIC CUBE 30 Instruction Manual

Automatic instrument for the determination of the erythrocyte sedimentation rate (esr)
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INSTRUCTIONS MANUAL
Software Release N°3.0
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 INSTRUCTIONS MANUAL Software Release N°3.0 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. 2/50...
  • Page 3 Changed software release 3.0 2.00 of 02/16 3.00 10/14 Complete restyling APPLICATION OF THE MANUAL This manual applies to the following models of the VES-MATIC CUBE 30: DIESSE Code Model description 10390 VES-MATIC CUBE 30 Rev 2.0 of 02/2016 3/50...
  • 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 It is important that this user manual is stored together with the instrument for future reference. In case of sale or transfer make sure that this manual accompanies the VES-MATIC CUBE 30 to allow new users to know about the instrument functionality and the related warnings.

  • Page 6: Table Of Contents

    Instructions Manual CONTENTS CHAPTER 1 ............................8 1.0 INTENDED USE OF THE INSTRUMENT ..................8 1.1 PRESENTATION OF THE INSTRUMENT ..................8 1.2 GENERAL DESCRIPTION OF THE INSTRUMENT ..............10 1.3 MATERIAL SUPPLIED WITH THE INSTRUMENT ..............11 1.4 LIST OF MATERIAL REQUIRED BUT NOT PROVIDED ............. 12 1.5 TECHNICAL SPECIFICATIONS ....................
  • Page 7 Instructions Manual 7.4 MESSAGE REQUESTING TEST TUBES TO BE PROCESSED: COMMAND 0X50 ....39 7.5 REPLY MESSAGE WITH COMMAND DATA ................41 7.6 RESULT SENDING MESSAGE: COMMAND 0X51 ..............42 7.7 QC (QUALITY CONTROL) SAMPLE DATA SENDING MESSAGE: COMMAND 0X52 ....44 7.8 EXAMPLE OF SERIAL PROTOCOL ....................

  • Page 8: Chapter 1

    Automatic instrument for the determination of erythrocyte sedimentation rate (ESR). PRESENTATION OF THE INSTRUMENT VES-MATIC CUBE 30 is a bench instrument designed and programmed to measure the Erythrocyte Sedimentation Rate (ESR) of up to a maximum of 30 blood samples contained in test tubes coming from the blood cell counter used in the laboratory, therefore, neither double sampling nor biological material transfer is necessary.
  • Page 9 According to the scientific literature, normal ESR values are between 1 and 10 mm/h for men and between 1 and 15 mm/h for women; in pathological conditions they can increase to values of up to 100 mm/h and above. Approximate normal range of the VES-MATIC CUBE 30 instrument: MALES up to 10 mm/h...

  • Page 10: General Description Of The Instrument

    Instructions Manual GENERAL DESCRIPTION OF THE INSTRUMENT LEGEND: Keypad Display Paper drawer with printer slot Instrument lid 30-postion test tube holding plate Numbered test tube positions Check device housing Barcode reader Housings for fitting the plate reducer required rubber- capped test tubes Fig.

  • Page 11: Material Supplied With The Instrument

    14) USB connector 15) Forced ventilation fan MATERIAL SUPPLIED WITH THE INSTRUMENT VES-MATIC CUBE 30 is supplied with the following materials: - An instruction manual. - Two spare fast-blow fuses, 1A (5x20) each. - A plate reducer for using rubber-capped test tubes.

  • Page 12: List Of Material Required But Not Provided

    Instructions Manual LIST OF MATERIAL REQUIRED BUT NOT PROVIDED  Disposable gloves  Cleaning paper  Solutions for cleaning the instrument TECHNICAL SPECIFICATIONS CENTRAL UNIT AND Low-dissipation RISC 8-BIT technology; INTERFACES ATMEGA128 microprocessor TEST TUBE HOLDING PLATE With 30 numbered positions to host various types of test tube. OPTICAL UNIT A pair of optoelectronic devices (LED &...

  • Page 13: Block Diagram

    Instructions Manual BLOCK DIAGRAM (The detailed diagrams are contained in the Service Manual) Fig. 1.6.1 VES-MATIC CUBE 30 block diagram LEGEND: 1) CPU board 10) Printer interface 2) Motor driver board 11) Printer 3) Power supply 12) Lid unit solenoid...

  • Page 14: Technical Description Of The Instrument

    KEYPAD The keypad has 5 keys which are used to activate the VES-MATIC CUBE 30 functions. TEST TUBE HOLDING PLATE The plate has a radial crown with 30 numbered positions into which the test tubes are inserted. These are symmetrically tilted with respect to the rotation axis in such a way as to arrange the test tubes on the cone generator.

  • Page 15: Information Regarding Disposal

    COPPER EPOXY RESINS and SILICON PLASTICS The VES-MATIC CUBE 30 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 16: Chapter 2

    Instructions Manual CHAPTER 2 STORAGE AND TRANSPORT The VES-MATIC CUBE 30 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 17: Unpacking

    Instructions Manual The electrical system and relative sockets must all be fitted with efficient ground connections according to the regulations in force with regard to electrical installations. The instrument is fitted with an internal power supply that supports voltage surges as per the specifications indicated on the nameplate on the back side of the device;...

  • Page 18: Positioning

    2.4.1 must be respected (rear panel 20 cm from the wall, front panel free, left and right side panels 10 cm space). Fig.2.4.1 Positioning of the VES-MATIC CUBE 30 It is strictly prohibited to place anything on top of the instrument.

  • Page 19: Installation

    Instructions Manual 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. b. Open the door of the printer compartment and remove the elastic band holding the roll of thermal paper in place (used to prevent it from coming out of its housing during transport).

  • Page 20: Shutting Down And Shipping

    Instructions Manual SHUTTING DOWN AND SHIPPING Before shutting down and shipping the instrument it is recommended carrying out the following sanitising procedure: A) The instrument must be turned off and cleaned internally of all residues or spillages with a liquid detergent and left to dry. B) Use one of the ready-to-use spray cans of isopropyl alcohol available on the market.

  • Page 21: Chapter 3

    KEYBOARD Fig. 3.1.2 The VES-MATIC CUBE 30 is fitted with a Control Panel (Fig. 3.1.2) that allows easy access to all the programmes controlled by the software of the instrument. A LCD with numerous windows guides the user through all the procedures.

  • Page 22: Main Menu

    2 seconds. = to scroll up or down in the main menu (3) = to confirm the item selected in the main menu (3) 2 – Description DIESSE’s logo Instrument internal temperature Number of analyses performable without reloading the check device (see paragraph 5.4).

  • Page 23: Query To Host

    ID number acquired with the barcode reader, and the samples inserted up to that moment. QUERY TO HOST VES-MATIC CUBE 30 performs the ESR analysis directly on the test tubes used by the blood cell counter in the laboratory. Activating the host query, you can also select the samples to be subjected to the ESR analysis at the time of loading.
  • Page 24 Instructions Manual - Use the arrow keys to select the results to be analysed and press OK to access the next menu: Fig. 3.5.2 - At this point, you can decide whether you want to view the analysis results on the display (A) or print them: (A) Example of result display Fig.

  • Page 25: Instrument Setup

    Instructions Manual INSTRUMENT SETUP Going into user Setup, you can access a series of configurations. Fig. 3.6.1 CLOCK Selecting Clock from the user Setup menu, you can update the time and date. Once you have accessed, the following page will appear where you can set the time and date: - Use the arrow keys to change the selected item.
  • Page 26 OFF - for samples without barcode QUALITY CONTROL VES-MATIC CUBE 30 allows you to use the control blood ESR Control Cube (code. 10435 4x9 ml) or the control ESR Control Cube (code 10436 2x9 ml) which is a test to monitor the erythrocyte sedimentation rate values (ESR).
  • Page 27 Instructions Manual Instrument setup Instrument setup allows you to change the respective parameters of the two control blood levels (normal and abnormal): Lot: indicated in the information leaflet. Expiration date: the expiry date of the ESR control (information leaflet). Bar Code ID: the barcode shown on the sample whereby the instrument recognises that a control blood test tube is inserted.

  • Page 28: Recharge Cd

    CUBE line. Fig. 3.6.8 VES-MATIC CUBE 30 is supplied already tested and set up to perform the first ESR determinations without having to reload it. In order to reload the instrument using the check device, you need to be outside the analysis cycle with...
  • Page 29 Instructions Manual 1. Open the lid of VES-MATIC CUBE 30. 2. Access Setup/User/Recharge_Cd from the menu. 3. You will be asked to insert the “Check Device Transponder RF” into the dedicated port (as shown in the figure 3.6.9). 4. Press OK.

  • Page 30: Chapter 4

    Instructions Manual CHAPTER 4 DESCRIPTION OF THE ANALYSIS CYCLE The analysis cycle provides the results according to the Westergren method with reading after one hour. Total analysis duration = 34 minutes. An analysis cycle can be divided into five main operations: ...
  • Page 31 Filling of the test tube For a correct execution of the ESR exam by the VES-MATIC CUBE 30 instrument, the level of blood in the test tube is fundamental. The instrument itself will verify the correct filling of the tube, measuring the level and comparing it with the preset tolerance values of maximum and minimum level.

  • Page 32: Preparation Of The Sample

    Fig. 4.2.1 Check of test tube labelling: The VES-MATIC CUBE 30 is prepared to work with maximum 2 non-overlapping labels applied on the test tube of the sample to be analysed. The reading unit sensor is able to detect correctly the sedimentation rate inside each sample, reading it through a maximum of 3 paper layers, along the reading axis.
  • Page 33 Instructions Manual Fig. 4.2.2 It is also preferable to enter the samples in such a way that the sample layers are opposite the emitter. Fig. 4.2.3 It is important to verify, before loading the instrument, that the labels adhere perfectly to the tubes: the adhesive parts, if unattached, could cause frictions during the mechanical movements of the groups.

  • Page 34: Test Tube Types

    Instructions Manual TEST TUBE TYPES VES-MATIC CUBE 30 is capable of analysing various types of test tube (Figure 4.2.1) in the same cycle, however, there are limitations for rubber-capped test tubes that require the plate reducer in order to be processed.

  • Page 35: Chapter 5

    Instructions Manual CHAPTER 5 GENERAL RECOMMENDATIONS The VES-MATIC CUBE 30 is designed and constructed to in such a way that a minimum maintenance is required. For any intervention: - disconnect the power from the instrument. - use the personal protective equipment, required while operating the instrument.

  • Page 36: Substitution Of The Fuses

    Instructions Manual Fig. 5.3.1 Cut off the end of the paper strip with scissors making a clean cut and insert it in the paper guide opening respecting the paper feed direction. Turn on the instrument. Feed in the paper until it starts auto-loading. Push down the print head lever.

  • Page 37: Checking The Safety Devices (Micro-Switches) And Acoustic Devices

    Instructions Manual 3. Replace the blown fuses with the new ones provided. 4. Refit the fuse box and reconnect the instrument to the mains. 5. Turn the instrument back on. If the fuses blow again when turning on, contact Technical Service. CHECKING THE SAFETY DEVICES (MICRO-SWITCHES) AND ACOUSTIC DEVICES Follow the procedure below to check functionality of the safety devices.

  • Page 38: Chapter 6

    Instructions Manual CHAPTER 6 AUTODIAGNOSTICS As well as controlling and driving the peripheral devices, the microprocessor continuously controls the most important parts of the instrument. When a fault occurs, the cycle in progress is automatically interrupted and an acoustic signal sounded and at the same time the type of fault or problem that has occurred is shown on the display.

  • Page 39: Chapter 7

    The type of protocol used sometimes enters codes (e.g. rack and rack position) that are set to default values for VES-MATIC CUBE 30 but are essential in order to align the protocol for the entire VES-MATIC CUBE line, hence allowing two instruments with the same protocol to be connected.
  • Page 40 ‘unknown’ codes remain in the pending database. Actually, VES-MATIC CUBE 30 sends one code at a time to the host, but it is useful to hypothesize that also 10 sample codes can be sent in order to be able to use the same connection for any VES- MATIC CUBE model.

  • Page 41: Reply Message With Command Data

    After sending the ACK message, the host computer should send the actual reply to the message 0x50. This reply will be identical to the message sent by VES-MATIC CUBE 30 (see paragraph 7.4.1), the only difference being that the barcodes sent will only be those to be processed by VES-MATIC CUBE and that the terminator will be 0x11 for “unknown codes”...

  • Page 42: Result Sending Message: Command 0X51

    Instructions Manual The data field for the message code 0x50 is made up as follows: H-NUM/ BarCode-1 Terminator BarCode-2 Terminator BarCode-n Terminator L-NUM (ASCII string of the (ASCII string of of the (ASCII string of of the ….. (2 HEX- of max 15 Barcode-1 max 15...
  • Page 43 Instructions Manual H-LEN/L-LEN: Length of the data field from Data-1 through Data-n represented in HEX-ASCII. Maximum Value ‘F’ (0x46) / ‘F’ (0x46). This is the actual number of bytes contained in the Data field. In fact, the maximum number of bytes contained in the Data field is 255. Data-1 ..

  • Page 44: Qc (Quality Control) Sample Data Sending Message: Command 0X52

    Instructions Manual H-FLAGS/L-FLAGS: 8-bit bitmap of the sample errors represented in HEX-ASCII. The following table defines the errors: Error Description Sample High Blood column too high Sample Low Blood column too low Sample Absent Test tube empty Reading Error Generic reading error QC PASS Reserved for samples with control blood QC FAIL...
  • Page 45 Instructions Manual Command: VES-MATIC CUBE sends the following frame: H-BLK L-BLK H-LEN L-LEN H-ADD L-ADD H-COM L-COM Data-1 ... Data-n ETX H-CHK L-CHK (0x3E) (0x30) (0x30) (0x30) (0x31) (0x35) (0x32) (0x0D) The hexadecimal values indicated in brackets are constant values for this message. The fields in bold type are variable and described below: H-LEN/L-LEN: Length of the data field from Data-1 through Data-n represented in HEX-ASCII.
  • Page 46 Instructions Manual String of 6 characters without “DDMMYY” terminator, where: ANALYSIS DATE: “DD” = day of the month, from “01” to “31” ASCII. “MM” = Month of the year, from “01” to “12” ASCII. “YY” = Year of the century, from “00” to “99” ASCII. String of 4 characters without “hhmm”...

  • Page 47: Example Of Serial Protocol

    Instructions Manual EXAMPLE OF SERIAL PROTOCOL 1. Example for the ESR analysis request on two samples (two barcodes, see paragraph 7.4.1) WARNING: The non-printable characters (<0x20) are represented with their hexadecimal value in square brackets [0x..]. VES-MATIC CUBE TX: >001401500201091053[0x10]20586743[0x10][0x0D]36 SAMPLE 1 SAMPLE 2 BARCODE +...

  • Page 48: Bibliography

    2. Pini F, Paoli L, Barlettani B, Campigli R, Faggiani L. Comparison of two systems for the determination of the erythrocyte sedimentation rate in blood/EDTA samples. 2010. DIESSE Diagnostica Senese S.p.A. Marketing information. 3. Westergren A.: The Technique of the red cell sedimentation reaction. Am. Rev. Tuberc. 1926; 14: 94-101.

  • Page 49: Attachment A: Ec Compliance Certificate

    Instructions Manual Attachment A: EC COMPLIANCE CERTIFICATE The current EC Declaration of Conformity is available for the download from DIESSE’s website www.diesse.it Attachment B: ACCESSORIES, SPARE PARTS AND CONSUMABLES  1 Roll of thermal paper h.mm l=57 D=50 [Ref: : R12300000] ...

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