operating manual - DIESSE Diagnostica Senese
Contents
1. 35 GENERAL 35 CLEANING THE INSTRUMENT 35 REPLACEMENT OF PRINTER PAPER rn 35 SUBSTITUTION GHEOGK DEVICE 36 REeFLACEMNENT OP TRE BUSES en ire 37 VERIFICATION OF SAFETY MICROSWITCHES AND keene 38 Rev 1 00 03 2010 34 61 S Operating manual VE 5 1 GENERAL RECOMMENDATIONS The VES MATIC cube 30 has been designed and produced to require minimum maintenance For any type of maintenance work WY Disconnect instrument from power supply Use the personal protection features foreseen during functioning Do not remove casing and do not remove safety devices AA In caso di fuoriuscita di sangue durante il ciclo di lavoro per pulire le superfici esterne dello strumento utilizzare i dispositivi previsti per la sicurezza personale 5 2 EXTERNAL CLEANING OF THE INSTRUMENT External cleaning is required for safety reasons Use a mild non aggressive detergent Contact an authorised Assistance Centre for internal cleaning 5 3 REPLACEMENT OF PRINTER PAPER Procedure 1 Disconnect instrument from power supply Press the printer hatch inwards and a click mechanism will open it Remove the paper pin Substitute the old paper roll with a new one Lift up the printer head using the side2. la M old This entry appears in the main menu only if the last analysis cycle has been deliberately A or accidentally B interrupted E g to introduce new samples into free positions to correct blood levels in samples to correct entered data B E g to interrupt the power supply The programme creates a backup file containing the information on the tested test tubes such as the ID number acquired using the barcode reader and the samples introduced up to that moment DESCRIPTION OF ANALYSIS CYCLE It also supplies results in agreement with the Westergren method using readings after one hour Total duration of test 33 minutes An analysis cycle can be broken down into five main operations e Loading e Sample shaking e Reference reading e Sedimentation e Analytical reading A detailed description of the various analytical cycle phases is given below LOADING Once the analysis cycle has started the instrument rotates the plate and stops at the position number one and the instrument will show the following screen display Rev 1 00 03 2010 Operating manual VES MELE Analysis ESR 1h CD 35407 Pos 01 Waiting sample code 16 15 22 04 09 sa E OH 000008 It will then be possible to enter the sample code and then the test tube or the test tube directly is the traceability given by the plate number is sufficient in this case it is better to set the working mode to OFF se
3. 13 e 28 PREPARATION REQUIRED BY THE CUSTOMER 14 e 29 14 e 2 10 COMPOSITION OF THE MACHINE INDICATIONS FOR DISPOSAE E 14 5 61 Rev 1 00 03 2010 Operating manual VES 2 1 GENERAL DESIGN OF THE INSTRUMENT WITH EXTERNAL CONNECTIONS LEGEND 1 Keyboard 2 Display 3 Paper holder drawer with printer hole 4 Sample holder drawer door 5 30 Test tube holder plate 6 Numbered test tube holder positions 7 Housing for check device 8 Barcode reader 9 Housing for reducer plate required for rubbers Fig 2 1 1 Front view Rev 1 00 03 2010 6 61 NIECCE LLL Operating manual VES SEs fig 2 1 2 Rear view LEGEND 10 Switch ON OFF Fuses and voltage changer Socket for power cable 13 RS 232 connector for connection to external computer Connector 485 Forced air fan 7 61 Rev 1 00 03 2010 Operating manual VE 2 2 BLOCK DIAGRAM 8 9 eee The detailed diagrams can be found in the Assistance Manual Fig 2 2 Block diagram Ves Matic Cube 30 LEGEND 1 CPU board 2 Motor Drivers board 3 Feeder 4 Motor block 5 Reading Sensor Unit 6 Check Device Unit 7 Display Keyboard interface 8 Graphic display 9 Keyboard Rev 1 00 03 2010 10 11 12 13 14 15
4. VES Mis 30 OPERATING MANUAL Software release 2 06 Automatic professional laboratory device for the determination of the erythrocyte sedimentation rate ESR patented NIECCE INNOVATIVE CLINICAL DIAGNOSTIC SYSTEMS NIECCE Ve Operating manual VE teal MANUFAC TURER AGENT DIESSE DIAGNOSTICA SENESE S p A Via delle Rose 10 53035 Monteriggioni SI Italy Tel 39 0577 587111 Fax 39 0577 318690 WWW diesse it LEGAL REPRESANTATIVE MANAGING DIRECTOR Dr Francesco Cocola REGISTERED AND ADMINISTRATIVE OFFICE Via A Solari 19 20123 MILANO Italy Tel 39 02 4859121 Fax 39 02 48008530 DIESSE ASSISTANCE CUSTOMER CARE Via del Pozzo 5 53035 Monteriggioni SI Italy Tel 39 0577 319556 Fax 39 0577 319020 e mail customercare diesse it DIESSE INC 1690 W 38 Place Unit B1 Hialeah FL 33012 U S A Phone 305 827 5761 1 877 DIESSE 3 Fax 305 827 5762 e mail salesoffice diesse us DIESSE ASSISTANCE DIESSE INC 1690 W 38 Place Unit B1 Hialeah FL 33012 U S A Phone 800 582 1937 TECHNICAL ASSISTANCE DIESSE INC CUSTOMER CARE CUSTOMER CARE 1690 W 38 Place Unit Bi Hialeah FL 33012 Tel 1 877 343 7733 Fax 805 827 5762 e mail customercare diesse us Rev 1 00 03 2010 ii Operating manual VE 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 mean
5. EXAMPLES See following table ESR value we sent Bytes of the string 0x20 0x20 0x20 0x31 140 Ox3E 0x31 0x34 0x30 H FLAGS L FLAGS 8 bit Bitmap of the sample errors represented in HEX ASCII The following table illustrates the errors Description 0 Sample High Sample tube overfilled Sample Low Sample tube underfilled 1 5 ml Sample Absent Test Tube Empty Error in acquisition of height 4 QC PASS The ESR of the QC measured is within the NENNEN d 5 QC FAIL The ESR of the QC measured is outside NENNEN 87 Reed EXAMPLES n the case of a Sample High error the Bit 0 least significant will be set to one and all the others to zero therefore the byte of the Flags will have a 0x01 hexadecimal value and its HEX ASCII representation will be 0x30 0x31 n the case of a QC Fail error the Bit 5 will be set to one and all the others to zero therefore the byte of the Flags will have a 0x20 hexadecimal value and its HEX ASCII representation will be 0x32 0x30 RACK ID A string of 4 characters without terminator identifies the sample holder rack in which the sample has been repositioned POSITION A string of 2 characters without terminator identifies the co ordinates of the position in which the sample has been repositioned in the sample holder rack Heply from the Host Computer Upon receiving a message the Host computer must send an ACK message to acknowledge correct receipt an
6. 1 61 1 00 03 2010 Operating manual VES 1 1 PRESENTATION OF THE INSTRUMENT The VES MATIC cube 30 is a bench tool that can measure the erythrocyte sedimentation rate ESR of 30 blood samples human and animal at the same time The instrument carries out the ESR analysis directly from the test tubes being used on the blood cell counter in the laboratory duplicate samples or extravasation of biological material are therefore unnecessary The test is carried out automatically and the results are comparable with the ones obtained using the Westergren method The instrument is managed by a microprocessor and its functionality will be described in more detail in the forthcoming paragraphs 1 2 WARRANTY DIESSE DIAGNOSTICA SENESE S p A subjects all its products to strict quality controls However should the instrument show signs of malfunctioning despite these controls you are invited to contact the authorised Technical Assistance Centre indicated to you at the time of delivery of the instrument General warranty regulations DIESSE DIAGNOSTICA SENESE S p A guarantees the VES MATIC Cube 30 for a period of 24 months from the delivery date the date on the transport document shall be valid for defects in the materials or manufacturing Should the product prove to be defective during the guarantee period the authorised Assistance Centres will repair it and you will only be charged the transport costs Terms 1 Th
7. 16 17 nireer Printer interfacer Printer Solenoid Unit door Door Micro switch Forced air fan ON OFF switch with network filter External connections Barcode reader 8 61 Operating manual VE 2 3 9 61 NIECCE S TECHNICAL DESCRIPTION OF THE INSTRUMENT CENTRAL UNIT Controls and processes the incoming data from the sensors and manages all peripherals it understands the FLASHEPROM which contains the programmes it also contains the EEPROM where read and processed data is memorised OPTICAL READING UNIT Unit made up of a photodiode phototransistor pair MOTORS FOR TILTING AND ROTATION OF TEST TUBE HOLDER PLATE A motor tilts the test tube holder plate to 90 and another motor turns it using the shaft in order to ensure the homogeneous suspension of red blood cells OPTICAL READING MOTOR UNIT Lifts the optical reading unit for controlling the test tubes inside the blood level and the sedimentation KEYBOARD It has 5 buttons which are used to activate the various functions on the VES MATIC cube 30 TEST TUBE HOLDER PLATE The plate comprises a radial crown with 30 numbered sites for inserting the test tubes These are symmetrically tilted compared to the rotation axis to arrange the test tubes on the cone generator The test tube holder plate also has a reducer which is needed to use rubber test tubes Only use the plate reducer when rubber test tubes are used ACOUSTIC SIGNAL
8. Carraro P D Osualdo A Di Vito S N Paleari C D Valutazione del Sistema Ves Tec VES MATIC Confronto con il Metodo ICSH Il Patologo Clinico 1985 4 120 Jou J M Insa M J Aymeric M Vives Corrons J L Evaluaci n de un Sistema Totalmente Autom tico para realizar la Velocidad de Sedimentacion Globular Sangre 1988 33 6 474 478 Prischl Schwarzmeier J D Automatisierte Bestimmung Blutkor perchensenkungsgeschwindigkeit VES MATIC Einsatz im Krankenhaus Berichte der OGKOC 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 Vallespi Sole T Valor Actual de la Velocidad de Sedimentaci n Globular Lab 2000 1989 19 5 14 Fernandez de Castro M Fern ndez Calle P Viloria A Larrocha C Jimenez M C Valoraci n de un Sistema Alternativo Totalmente Autom tico para la Determinaci n de la Velocidad de Sedimentaci n Globular Sangre 1989 34 1 4 9 Koepke J A Caracappa P Johnson L The Evolution of the Erythrocyte Sedimentation Rate Methodology Labmedica 1990 Feb Mar 22 24 Caswell M Stuart J Assessment of DIESSE VES MATIC automated system for measuring erythrocyte sedimentation rate J Clin Pathol 1991 44 946 949 Manley R W J Clin Pathol 1957 10 354 ICSH Recommendation for Measurement of Erythrocyte Sedime
9. SIX H BLK L BLK H LENL LEN H ADD L ADD H COM L COM ETX H L Ox3E 0x30 0x30 0x30 0x31 0x35 0x30 0x0D CHK CHK The hexadecimal values indicated in brackets are constant values for this message The fields in bold print are variable and are described below H LEN L LEN Length of the data field from Data 1 to Data n inclusive represented in HEX ASCII Maximum Value F 0x46 F 0x46 This is the effective number of bytes contained in the Data field In fact the maximum number of bytes accepted in the DATA field is 255 Rev 1 00 03 2010 44 61 NIECCE S Operating manual VE Data 1 Data n Data Field The data field for the message code consists of the following BarCode 1 Terminator BarCode 2 Term BarCode n Term ASCII String For the ASCII String For the ASCII String of the max 15 barcode 1 max 15 barcode max 15 Barcode n characters string characters 2 string characters string 0x10 0x10 0x10 H NUM L NUM Number of bar codes contained in the message represented by HEX ASCII BARCODE n ASCII string with variable length maximum of 15 characters allowed It is the barcode that is read by the Ves Matic Cube Barcode Reader Terminator Each string of the barcode is terminated with the byte Ox10 This is because the length of this string is variable The number of bar codes contained in the data field is limited by the fact that the data field itself
10. Operating manual VE Matic NIECCE CHAPTER 4 OPERATORS INSTRUC HONS EE ra 19 41 KEYBOARD COMMANDS crecieron EAE 20 42 PREPARATION OF SAMPLES eioen rina 20 e 43 TYPES OF TEST TUBES 24 44 SWITCHING ON THE INSTRUMENT i 25 40 raga aaa 26 e 46 DESCRIPTION OF ANALYSIS CYCLE 27 dl ROSTER 28 e 48 VISUALISING AND PRINTING OF STORED 29 e 49 INSTRUMENT 31 T 31 402 EANGUA CE e EE 32 49 3 TEMPERATURE SCALE uan 32 4094 PARAME TERS aaa 32 s 95 WORRING MODE cele alia 33 OE a 33 E PRINTOUT oserei 33 65 33 19 61 Rev 1 00 03 2010 E nireer Cj MATIC Operating manual VE 4 1 KEYBOARD COMMANDS Fig 4 1 Keyboard The keys on the keyboard correspond to a virtual button at the bottom of the display The buttons are reconfigured on the display each time a button is pressed depending on the function selected The selected function is only activated when the corresponding key is pressed and released 4 2 PREPARATION OF SAMPLES No specific preparation of the test tubes is necessary as the Ves Matic Cube 30 uses the ones from another analytic system hemochromocytometric test I
11. on the Ves Matic Cube back panel shows the following pin out SIGNAL Rx data from Host Tx data to Host GND The type of protocol used sometimes enters codes e g rack and rack position that are set to default values for the cube 30 but which are essential for aligning the protocol for the entire Ves Matic Cube line thus allowing two instrument with the same protocol to be connected 7 2 FOREWORD HEX ASCII REPRESENTATION In the protocol described below many of the parameters and data are represented in Hexadecimal ASCII HEX ASCII format in other words a byte with a value of Ox7A is represented by two ASCII characters 7 0x37 and A 0x41 the first represents the most significant nibble and the second the least significant Examples Original Byte HEX ASCII Representation As can be noted this type of representation means that two ASCII characters are necessary for the representation of the value of one byte 7 3 GENERAL NOTES RESPONSE DELAYS To allow the machine time to activate the reception mode it is necessary to enter a delay of 1 second on the reply 43 61 Rev 1 00 03 2010 m NIECCE S MoT Operating manual VE 7 4 REQUEST FOR TEST TUBES TO BE PROCESSED MESSAGE COMMAND 0X50 This message is sent by the Ves Matic Cube towards the host computer The message contains the test tube barcode The host computer must reply to this message with a similar message containing the barcode among
12. DEVICES 18 Rev 1 00 03 2010 iii 6 Operating manual VE CHAPIER dici ORERATORS INSTRUC TIONS alla e 4 1 KEYBOARD COMMANDS essen nennen enne nennen e 4 2 PREPARATION OF SAMPLES e 4 5 MAIN MENU e 4 6 DESCRIPTION OF ANALYSIS CYCLE e 4 9 INSTRUMENT SETUP e 4 9 2 LANGUAGE e 4 9 5 WORKING MODE e 4 9 6 QUALITY CONTROL MAINTENANCE pn E e 5 1 GENERAL RECOMMENDATIONS esee e 5 2 EXTERNAL CLEANING OF THE INSTRUMENT e 5 3 REPLACEMENT OF PRINTER PAPER e 5 4 SUBSTITUTION OF THE CHECK DEVICE e 5 5 REPLACEMENT OF THE FUSES e 5 6 VERIFICATION OF SAFETY MICROSWITCHES AND ACOUSTIC DEVIGES onere oae a G m RUTO DAGNO IUe E e 6 1 AUTO DIAGNOSTICS ii e 7 1 FOREWORD TECHNICAL INFORMATION eene e 2 FOREWORD HEX ASCII REPRESENTATION e 7 3 GENERAL NOTES RESPONSE DELAYS e 7 4 REQUEST FOR TEST TUBES TO BE PROCESSED MESSAGE COLLIDER e 7 5 RESPONSE MESSAGE WITH COMMAND DATA e 7 6 RESULT SENDING MESSAGE COMMAND 0X51 Rev 1 00 03 2010 e 43 We OE TESISHUBES ceca doi aieo Etpe EE 8 0 1 0 9 m e 4 8 VISUALISING AND PRINTING OF STORED ANALYSES d AE EOE e 7 7 QC QUALITY
13. SYSTEM This functions as an alert for the operator during specific phases of the work cycle A beep sounds each time the buttons on the keyboard are pressed TEMPERATURE SENSOR It is used to measure the temperature and is placed on the central unit next to test tube holder plates PRINTER It prints the test results at the end of each work cycle DISPLAY It is used to view all the instrument s messages Rev 1 00 03 2010 m NIECCE S MoT Operating manual VE 2 4 TECHNICAL SPECIFICATIONS CENTRAL UNIT AND With low dissipation RISC 8 BIT technology INTERFACES ATMEGA128 microprocessor TEST TUBE HOLDER With 30 number places it can hold various types of test tubes OPTICAL UNIT One couple of optic electronic elements Led amp analogical sensor PRINTER Alphanumeric with thermal paper 58 mm wide 36 characters per line speed 20 mm sec DISPLAY Liquid crystal screen 240x128 pixel back lighting with cfl lamp POWER SUPPLY 110 to 230 VAC 50 60 Hz FUSES 2 X 1 0A Fast 5 x 20 mm ABSORBED 65 W max ELECTRICAL POWER DIMENSIONS 510 x 350 x 500 mm Ixhxd WEIGHT 20 Kg WORKING from 15 C to 35 C TEMPERATURE STORAGE from 5 C to 45 C TEMPERATURE RELATIVE HUMIDITY from 20 to 80 without condensation PLATE ROTATION 1 Rotation every 1 5 seconds during normal functioning SPEED CLASSIFICATION CLASS 1 equipment IEC classification Rev 1 00 03 2010 10 61 Operating manual VE 2 5 NIEC
14. TEXT MUST BE FULLY KNOWN AND UNDERSTOOD BEFORE PROCEEDING Co DANGER POTENTIALLY INFECTED SUBSTANCE A OBLIGATORY CARRY OUT ALL FUNCTIONS DESCRIBED BELOW FORBIDDEN DO NOT CARRY OUT THE FUNCTION DESCRIBED BELOW GENERAL INFORMATION PARTICULARLY IMPORTANT NOTES IO PRINTING THE DATA CLEANING THE INSTRUMENT BY THE OPERATOR Rev 1 00 03 2010 4 61 NIECCE Operating manual VE CHAPTER 2 lE Rugs 5 This chapter aims to provide all the information required for identifying installing and starting up the instrument Below is a list of the technical specifications and the product composition as required by European Directives to allow a safe use and disposal at the end of the life cycle The INSTALLATION must be carried out by an Technical Installer authorised by Diesse Diagnostica Senese SpA with a subsequent Installation Report Refer to the Installation Check guide DISCONNECTION and SHIPMENT of the instrument must be performed by a Technician authorised by DIESSE Diagnostica Senese S p A e 2 1 GENERAL DESIGN OF THE INSTRUMENT WITH EXTERNAL 6 22 Lan 8 e 23 TECHNICAL DESCRIPTION OF THE INSTRUMENT li 9 e 24 TECHNICAL 10 29 RR Lan 11 e 26 INSTRUCTIONS FOR TRANSPORT i 11 6 27 PIACEMENT
15. The host computer must only reply to this message with an ACK or NACK type message to notify the successful receipt of the results or the presence of errors in the message N B the samples that were analyzed by the instrument with the attribute unknown code are not sent automatically at the end of the analysis process but can only be sent manually by the operator by means of the command Send to host from the management menu of the pending database Control Ves Matic Cube sends the following frame STX H BLKIL BLK H L ADD H ETX H 0 30 0x30 LEN LEN ADD 0x31 COM ir CHK bs 0x30 0x35 0x31 The hexadecimal values indicated in brackets are constant values for this message The fields in bold print are variable and are described below H LEN L LEN Length of the data field from Data 1 to Data n inclusive represented in HEX ASCII Maximum Value F 0x46 F 0x46 This is the effective number of bytes contained in the data field In fact the maximum number of bytes accepted in the DATA field is 255 Data 1 Data n Data Field The data field for the message code 0x51 is as follows 76 Rev 1 00 03 2010 m NIECCE S MoT Operating manual VE H PRO L PRO Test Tube 1 Test Tube n Record 2 bytes HEX ASCII Record H PRO L PRO Number of Test Tube records contained in the message represented in HEX ASCII The Test Tube Record number contained in the data field is limited by the fact
16. and the date SETUP Select hour Use the arrows to set up Press OK to store 31 61 After entering the submenu the following screen will appear to set the time To change the submenu selected use the arrow keys By pressing the OK key confirm the entered value the confirmation message Memorised Appears on the display and then proceed to next item set sequence hours minutes date month year At the end of the sequence the programme automatically reappears to the Setup menu Rev 1 00 03 2010 Operating manual VES 4 9 2 LANGUAGE Permits the instrument language to be chosen in fact the following window appears when we select this command To change the language select the language required moving up and down using the arrow keys and then press the key OK SETUP Italkano Eng ish Francais Espano Fonugues 00000 4 9 3 TEMPERATURE SCALE This setting allows you to change the temperature scale choosing between degrees Celsius or degrees Fahrenheit 4 9 4 PARAMETERS This screen allows you to change some parameters Enable disable the Temperature correction emm If the temperature parameter is set to ODD the E E NEN instrument determines the value of erythrosedimentation a Display ON rate ESR and shows the results at ambient temperature ES E o neo f H it can b d to show th a P nirevem owever It can be programmed to show the results at a temp
17. by the Ves Matic Cube Barcode Reader Rev 1 00 03 2010 46 61 NIECCE S Operating manual VE Terminator Every string of the bar code is terminated by a 0x10 byte or a Ox11 byte for unknown codes This allows the management of the variable length of the codes as well the management of unknown codes The number of bar codes contained in the data field is limited by the fact that the data field itself can contain a maximum of 255 bytes in any case the bar codes are never truncated but always complete with terminator If the barcode string ends with the byte 0x10 it means that the sample must be processed by the Ves Matic Cube At the end of the test the result will be printed out and stored in the historical database If the barcode string ends with the byte 0x11 it means that the sample code is unknown in this case the Ves Matic Cube will process the sample but the result will not be printed at the end of the test but will be stored in the Pending Database Timeout on Message with Data 5 Seconds 7 5 1 Error on Reply Message with Data If the Ves Matic Cube detects an error in the reception of this message it will repeat the transaction from the beginning resending the request message as set out in paragraph 7 4 1 7 6 RESULT SENDING MESSAGE COMMAND 0X51 This message is sent by the Ves Matic Cube towards the host computer The message contains the results of the analysis performed on one or more samples
18. can contain a maximum of 255 bytes in any case the bar codes are never truncated but always complete with terminator 7 4 1 H CHK L CHK CheckSum of the message represented in HEX ASCII The Checksum is calculated by carrying out the OR exclusive of all the bytes sent from STX to ETX inclusive The resulting hexadecimal value is then converted into HEX ASCII and the two characters that represent it are sent ATTENTION for debugging purposes it is possible to disable the checksum control replacing the H COM bytes with the value of 0x44 instead of 0x35 In this case the two bytes of the checksum are still sent but their value will be insignificant The Host computer must also manage any possible cases in which the checksum is disabled Heply from the Host Computer Upon receiving the message the Host computer has to first send an ACK message to acknowledge correct receipt and interpretation of the message meaning that all the fields have the correct values and the checksum is correct or a NACK message to indicate that the message contains one or more errors inexact checksum incorrect length of the data field etc ACK message ACK H ADD L ADD ETX 0x06 0x30 0x31 OxOD Timeout on ACK Message 2 Sec 451 Rev 1 00 03 2010 NIECCE MoE Operating manual VE NACK messag e NACK H ADD L ADD L ERR ETX 0x15 0x30 0x31 OxOD where H ERR L ERR are the HEX ASCII representation of the error code
19. for a maximum period of 24 hours In this case make sure that the sample has reached ambient temperature before inserting it into the instrument Check that there is no coagulation turning the test tube upside down before inserting it into the instrument Verify that the test tube is hermetically closed Sample Labelling The Ves Matic Cube is prepared to work with maximum 2 labels that are not overlapping and which are applied to the test tube sample to be analysed reading it through a maximum of 3 paper layers along the reading axis Therefore if one test tube has two labels it is necessary to enter the sample in such a way that the reading axis has no more than three layers of paper see figure It is also preferable to enter the samples in such a way that the sample layers are opposite the emitter 21 61 Rev 1 00 03 2010 Operating manual VES MELE Reading Axis Reading Axis 3 Receiver 3 md Receiver nd 2 Layer TE LJ Factory Label Y Factory Label Barcode Label x57 1 Layer 4 2 ayer Barcode Label 1 Layer fa Emitter Light Emitter Reading Axis N Light Receiver Reading Axis x Sola ye E X E ad La yer Vea Factory Label Tube cross section N Barcode Label m factory Label Barcode Label uw de 2 Layer Layer Light Emitter 2 TTT Layer Max 3
20. instrument we recommend that the original E packaging is preserved including the internal parts especially the polyurethane foam blocks that block the sample holder plate in its housing Rev 1 00 03 2010 12 61 Operating manual VES MES 2 7 PLACEMENT The environment intended for this instrument is the laboratory For normal safety reasons and given the type of analysis carried out the instrument must be placed away from sources of heat in areas not accessible to liquids in environments free from dust and on perfectly flat work benches that are not subject to shocks or vibrations The safety distances described 20 cm back to wall front of instrument free left and right sides 10 cm must be observed to prevent the instrument from overheating obstruction of fan and to act quickly on the switch and power cable in the event of danger to stop the machine from overheating It is totally prohibited to place any material on the instrument for the same reason 10 cm Fig 2 7 Never move the instrument after it is properly installed Should movement or Ds relocation of the instrument be necessary a re verification of the conditions listed in this paragraph would be required before using the instrument again Whenever the instrument will not be used for an extended period of time it is suggested that it is disconnected from the power source and covered 13 61 Rev 1 00 03 2010 Operating manual VES MELE 2 8 PR
21. laboratory use Part 1 General requirements EN 61326 1 Electrical Equipment for Measurement Control and Laboratory Use Electromagnetic compatibility requirements Part 1 General requirements And therefore meets the minimum requirements of the following Community directives and their amendments Low Voltage Directive 2006 95 EEC Electromagnetic Compatibility Directive 89 33 93 68 and 2004 108 EEC Place date of issue Monteriggioni 01 April 2009 signature Francesco Cocola General Manager This is the certified copy of the original document stored in archive of DIESSE Diagnostica Senese SpA PR Issued Monteriggioni 20 April 2010 4 Tout PF Gabriele Monciatti R A Manager Rev 1 00 03 2010 56 61 Operating manual VES ANNEX B WARRANTY CERTIFICATE Y N Terms 1 The warranty will only be acknowledged if the warranty certificate is sent together with a copy of the transport documents and the installation report within 15 days of delivery 2 This produce will not be considered to have material or manufacturing faults if it is adapted changed or regulated to comply with national or local regulations in force in a country other than the one for which the product was originally designed and made This warranty shall not cover said adaptations modifications or adjustments or any attempts at the same irrespective of whether performed correctly or incorrectly or any damage der
22. lever at oe 6 Insert the end of the paper strip in the opening of the paper guide taking care to level it precisely with a pair of scissors and respecting the paper rotation direction 35 61 Rev 1 00 03 2010 Operating manual VES 7 Turn on the power supply 8 Push the paper as far as possible until it begins to load automatically 9 Lower the print head lever 10 The paper enters until it comes out of the front of the printer if the paper does not come out press the key S2 top left on the control board 11 Pull the paper outwards so that it is cut 12 Rip off the paper jutting out of the front of the printer Close the hatch 5 4 SUBSTITUTION OF THE CHECK DEVICE The check device is an electronic device that allows the instrument to have a defined number of executable tests available For every result the check device will automatically undergo a decrease of the number of available tests Once the tests have been loaded it is necessary to recharge the instrument using the special Check Device Transponder RF see figure The test tube looks like a normal vacutainer test tube and can be used to load any instrument into the Ves Matic Cube line The Ves Matic Cube 30 is supplied as already controlled and ready to carry out the first ESR tests without any recharging To carry out check device recharging it is necessary to follow the simple procedure described below with the instrument turned on
23. manual VES MELE 3 1 THE INSTRUMENT The VES MATIC cube 30 is a bench instrument designed and planned to measure the Erythrocyte sedimentation rate ESR of up to a maximum number of 30 blood samples contained in the same test tubes coming from the blood cell counter used in the laboratory In this way neither dual blood taking or a transfer of biological material are required The test is carried out automatically shaking and reading and the results are comparable with the ones obtained with the Westergren method bibl Reference 1 10 and if obtained at ambient temperature can be taken to the temperature of 18 automatically using the Manley nomogram fig 3 1 The VES MATIC cube 30 provides for excellent results equivalent to the Westergren method 1 hour in just 33 minutes including sample shaking Rear Temperatura i Found Coparecied P Ll 35 o0 25 7 70 65 i Fig 3 1 Clinical concept of the ESR The instrument provides information about the erythrocyte sedimentation rate ESR a measurement of the acute response phase to an inflammatory pathology and that reflects the speed with which erythrocytes sediment The ESR value measured in a certain moment is influenced by the concentration of some proteins whose plasma concentration changes in the presence of inflammation and other pathologies for example neoplasms It is also affected by some properties of the erythrocytes and the degree of anaemia ha
24. of two samples and authorisation response for analysis only for the second see paragraph 7 4 3 ATTENTION The non printable characters 0x20 are represented with their hexadecimal value between brackets 0x Request Ves Matic Cube TX gt 0014015002010910583 0x10 20586743 0x10 0x0D 36 Host Message TX ack 0x06 01 0x0D Host Reply TX gt 000B01500120586743 0x10 0x0D 5D SAMPLE 2 BAR ADD ba 29953 EI OHK TERMINATOR celata 53 61 Rev 1 00 03 2010 NIECCE Operating manual VE STX 0x3E gt H L BLK fixed value 00 H L LEN number of characters present in the data field OB hex 11 characters 2 for H L NUM 9 SAMPLE 2 BARCODE TERMINATOR H L ADD fixed value 01 H L COM command code for sample code to be processed request 50 H L NUM number of barcodes included in this message 01 hex 1 bar code SAMPLE 2 BAR CODE TERMINATOR ETX character OxOD H L CHK xor of all characters from STX to ETX included Rev 1 00 03 2010 54 61 Operating manual VE NIECCE eo BIBLIOGRAPHY 1 11 12 55 61 Westergren A The Technique of the red cell sedimentation reaction Am Rev Tuberc 1926 14 94 101 Silvestri M G Cozza E Bertoli G Federzoni C Marzullo F Determinazione Automatica della velocita di Eritrosedimentazione Assoc Italiana Patologi Clinici XXXIV Congresso Nazionale 1984 Abstract De Franchis G
25. p a assumes all liability for damages arising from manufacturing defects or malfunctioning of the instrument during the foreseen use of the same It declines any other type of liability Directive 1999 34 CE that amends the European Directive 85 374 EEC implemented in Italy via the Presidential Decree no 224 dated 24 May 1988 Legislative Decree no 25 dated 02 02 2001 REFERENCE LEGISLATION The manufacturing company DIESSE DIAGNOSTICA SENESE S p a declares that it abides by the manufacturing dispositions contained in the ISO 9000 standards It also declares that it has followed the Directives shown below for the design and manufacture of the VES MATIC cube 30 as indicated in APPENDIX A EC Declaration of Compliance 98 37 EEC 89 336 EEC REQUEST FOR TECHNICAL ASSISTANCE If Technical Assistance should be required please contact the centre you were informed about when the instrument was delivered otherwise contact Diesse Diagnostica Senese S p a See APPENDIX C REQUEST FOR SPARE PARTS The request for spare parts indicated on the order form see APPENDIX D can be made by the customer to request other spare parts please refer to the Assistance Manual Rev 1 00 03 2010 S Matic NIECCE Operating manual VE 1 7 PRINTING AGREEMENTS READ THE OPERATIONAL MANUAL AND INSTRUCTIONS OBSERVE THE SYMBOLS RELATING TO THE SAFETY FEATURES USED NW WARNING DANGER OF PERSONAL INJURY ALL THE CONDITIONS INDICATED IN THE
26. provide an acoustic signal if the instrument works correctly 3 Close the hatch and check that it is blocked in order to carry out reset At this point if the instrument works correctly the two conditions acoustic signal and blocking must be checked If they do not work contact technical assistance Rev 1 00 03 2010 38 61 Operating manual VE CHAPTER 6 AUTO DIAGNOSTICS e 6 1 AUTO 39 61 B NIECCE S Mans DILODE DIAGNO siti Cierre 42 Rev 1 00 03 2010 Operating manual VE 6 1 AUTO DIAGNOSTICS In addition to carrying out command and control operations for peripherals the microprocessor constantly controls the most important parts of the instrument When a fault occurs the current running cycle is automatically interrupted and an acoustic signal is sent At the same time the type of fault and problem appears on the Display screen The messages are as follows MESSAGE AND FAULT ERROR READING This occurs if the movement of the reading unit is not completed within the set time limit ERROR PLATE If the test tube holder plate does not make a full rotation in the preset time ERROR TRASLATOR If the test tube holder plate does not make a full translation in the preset time CHECK DEVICE EXHAUSTED This occurs when the Check Device is exhausted ERROR PRINTER This occurs when the printer has a problem Rev 1 00 03 2010 CAUSE AND SOLUTION In addition to pos
27. that the data field itself is able to contain up to a maximum of 255 bytes in any case the test tube records are never truncated Test tube record Barcode Terminator ASCII String of the string max 15 Barcode characters 0x10 charact characters BARCODE ASCII string with variable length maximum of 15 characters allowed It is the barcode that is read by the Ves Matic Cube Barcode Reader Terminator The barcodes string terminates with the 0x10 byte This is because the length of this string is variable DATA ANALYSIS String of 6 characters without DDMMYY terminator where DD day of the month from 01 to 31 ASCII MM Month of the year from 01 to 12 ASCII Y Y Year of the century from 00 to 99 ASCII ANALYSIS TIME String of 4 characters without hhmm terminator where hh hour of the day from 00 to 23 ASCII mm Minutes from 00 to 59 ASCII ESR Value of the ESR measured ASCII string without terminator from 0 8 Spaces 0 transmitted in the case of an error to 140 1 Space 140 If the result is higher than 140 the string will be gt 140 Rev 1 00 03 2010 48 61 NIECCE S Operating manual VE EXAMPLES See following table ESR value otring sent Bytes of the string 1 0x20 0x20 0x20 0x31 N B If traceability has been activated inside the sample holder rack the ESR r
28. 03 2010 28 61 Operating manual VES MES SEDIMENTATION After the reference reading the instrument waits for another 15 minutes for the erythrocytes to settle ANALYTICAL READING The last phase of the cycle is the final reading that allows the instrument to calculate the ESR values which are then forwarded to the user via the preset modes N B it is possible to abort analysis at any time by pressing the key ESC and then pressing the key OK 4 7 HOST QUERY As already stated the Ves Matic Cube 30 carries out ESR tests directly on test tubes used by the blood cell counter in the laboratory By activating the host query it is also possible to choose the samples that must carry out the ESR analysis during the loading phase In fact when the sample code is read by the instrument it also carries out a host query and once the answer has been received it will show up on the screen whether the sample must be analysed or not details on protocol section 7 4 8 VISUALISING AND PRINTING OF STORED ANALYSES Procedure By pressing the key Mem the following list appears if the instrument has carried out at least 1 analysis cycle VES30 ESR 1h ESR 1h ESR 1h ESR 1h ESR 1h ESR 1h 24 04 09 22 04 08 22 04 08 03 04 09 03 04 09 02 04 09 09 35 31 14 48 20 14 12 12 16 30 07 15 08 02 16 01 26 CD 35407 15 59 27 04 08 ee 17417717551 00080 The arrow keys are used to select the test results to b
29. CE eo SUPPLIED MATERIAL The VES MATIC Cube 30 is supplied with the following materials An INSTRUCTION MANUAL Two spare RAPID 1A fuses 5x20 each A plate reducer for using test tubes An IEC International Standard power supply cable Female Plug IEC 320 C 13 Male Plug Schuko CEE 7 VII Rating 10A 250Vac packing list and installation report Warranty certificate Consumables that can be purchased for using the instrument Check device Transponder RF 1K for Ves Matic Cube 1000 tests Ref 10292 Check device Transponder RF 5K for Ves Matic Cube 5000 tests Ref 10291 Check device Transponder RF 10K for Ves Matic Cube 10000 tests Ref 10290 ESR Control 9ml 2 Normal Bottles 2 Abnormal Bottles Ref 10430 ESR Control 9 ml 1 Normal Bottle 1 Abnormal Bottle Ref 10434 Thermal paper for printer 1 pack Ref 10403 2 6 INSTRUCTIONS FOR TRANSPORT 11 61 The VES MATIC cube 30 is a precision instrument and must be handled as such Inappropriate operations may damage the internal opto electronic parts and cause mechanical damage Given the machine s reduced volume and weight it can be transported manually using all necessary precautions to avoid knocks and excessive tilting which may damage the instrument Fig 2 6 Rev 1 00 03 2010 S NIECCE Operating manual VE PACKAGING DIMENSIONS WIDTH HEIGHT GROSS WEIGHT PACKAGING WEIGHT DEPTH For any later transportation of the
30. CONTROL SAMPLE DATA SENDING MESSAGE nireer Operating manual VE C Matic NIECCE COMMAND OZ e 50 e 7 8 EXAMPLE OF SERIAL PROTOCOL i 53 BIBLIOGRAPHY 55 APPENDIX A EC DECLARATION OF COMPLIANCE APPENDIX B WARRANTY CERTIFICATE APPENDIX C REQUEST FOR ASSISTANCE APPENDIX D APPENDIX E REQUEST FOR SPARE PARTS METHOD MANUAL ACCORDING TO THE WESTERGREN TECHNIQUE FOR DETERMINING EST Rev 1 00 03 2010 MATO NIECCE Operating manual VE CHAPTER 1 INTRODUC TON cigni N Before installation and use of the instrument for safety reasons it is advisable to read carefully the warnings and instructions contained in this user manual It is important that this user manual is kept with the device for future reference In the case of sale or transfer make sure that this manual accompanies the VES MATIC Cube 30 to allow the new users to be informed about the instrument functionality and its related warnings Use of this instrument is recommended by qualified and skilled personnel only e 1 1 PRESENTATION OF THE INSTRUMENT i ARR coos 1 39 LIMITS OF RESPONSIBIEI aaa e 1 5 REQUEST FOR TECHNICAL 5 5 T5 REQUEST FOR SPARE PARTO ir I 127 PRINTING AGREEMENTS
31. EPARATION REQUIRED BY THE CUSTOMER The instruments and operators safety is no longer guaranteed if one of the following conditions does not apply The power sourcework installation category Il must be compatible with the electrical requirements specifications and current indicated on the metal plate supplied on the rear of the instrument it is advisable that the efficiency of the electrical system is periodically verified V The network and relative outlets must be fitted with an efficient earthing connection following the laws in force The instrument has an internal power supply that stands variations in voltage as per specifications shown on the back plate of the equipment if the line suffers from severe interference use a normal saturated iron stabilizer 65 W minimum Before connecting with external instruments host PC Barcode Reader it is necessary to verify compatibility see the relative user manual with the specifics indicated in chapter 7 and verify that the earth connection between them is uninterrupted The operators protective equipment gloves containers for collecting used test tubes cleaning solutions for cleaning the instrument must be available The operator must be trained to ensure awareness of the procedures restrictions and warnings indicated in this manual in addition to the required laboratory safety procedures The location of the instrument should follow the guidelines indicated in paragraph abov
32. UND ON INSTRUMENT 59 61 Rev 1 00 03 2010 S Matic NIECCE Operating manual VE ANNEX D Spare Parts Request Form B a CUSTOMER COMPANY ADDRESS CITY Signature Fill out and send a legible copy of the following to CUSTOMER CARE DIESSE Via del Pozzo 5 53035 Monteriggioni SI Italy Tel 39 0577 319556 Fax 39 0577 319020 ASSISTANCE SERVICE e mail customercare diesse it Rev 1 00 03 2010 60 61 Matic NIECCE Operating manual VE ANNEX E METHOD MANUAL ACCORDING TO WESTERGREN S TECHNIQUE FOR DETERMINING THE ESR In order to measure the ESR according to Westergren s technique follow the recommendations of the International Committee for Standardisation in Haematology ICSH bibliog ref 12 13 outlined below Materials Blood collected no later than three hours previously on EDTA K2 1 5 0 25 mg per mL of blood or su EDTA K3 1 7 0 3 mg per mL of blood The haematocritical value must be between 30 and 36 PCV packed cell volume 0 33 0 03 Anti coagulant diluting solution comprising Trisodium Citrate Dihydrate 1009 mmol L 3 28 g dissolved in 100 ml of distilled water Glass sedimentation test tubes with the following dimensions total length 300 1 5 mm internal diameter 2 55 0 15 mm with a uniformity of 0 05 mm graded scale 200 0 35 mm long subdivided into 10 mm steps or less with a maximum error tolerance between two consecutive divisions of 0 2 mm the t
33. ate For this reason we advise that settings are made according to the samples used ON for samples with barcode OFF for samples without barcode QUALITY CONTROL With the VES MATIC cube 30 instrument it is possible to use the control blood ESR control code 10430 4x9 MI that represents a test to monitor Erythrosedimentation rates ESR Please refer to the information leaflet for methods of use and procedures Setting the instrument It is possible to change the control blood parameters from this setting Batch written on the product information leaflet IDNORMAL IDAMNORMAL are the codes shown on the control blood sample thanks to e DNORMAL ATERTB Which the instrument recognises them i fil a NORMAL ABNORMAL are the ranges of SABNORMAL 26 140 acceptability for that control blood sample information leaflet Date is the expiry date for the ESR control 9 2 2 4 information leaflet 80808080 To 7 i i change the values move up and down the items using the arrow keys The set value can be changed by scrolling with the arrows and then pressing OK SETUP 4 9 7 QC PRINTING This function is used to print the settings for control blood 4 9 8 CD RECHARGING This operation permits recharging of the Check device see paragraph 5 4 Rev 1 00 03 2010 Operating manual VE CHAPTER 5 MAINTENANCE e 5 2 e 5 3 e 5 4 e 5 5 S Matic NIECCE
34. but when no analysis cycle is running DIESSE 3 p A VES CUBE CARD 1000 1 Open the Ves Matic Cube 30 lid 2 Enter setup user Recharge Cd from the menu 3 The instrument will ask you to introduce the Check Device Transponder RF into the specific housing see figure 4 Press OK o At this point the instrument will show a message stating that recharging has been completed and the test counter will increase Replace the Check Device when it is not completely worn out when there are at least about sixty tests that can still be carried out Rev 1 00 03 2010 36 61 Dus Operating manual VE 5 5 REPLACEMENT OF THE FUSES If it necessary to replace fuses proceed as follows 1 Turn off the instrument and disconnect it from the power supply 2 Remove the fuse box using a straight screwdriver 3 Replace the damaged fuses with new ones supplied with the instrument 4 Return fuse box and reconnect instrument to power supply 5 Turn on the power supply 37 61 Rev 1 00 03 2010 S Matic NIECCE Operating manual VE If the fuses blow again when the machine is turned on contact Technical E Assistance em 5 6 VERIFICATION OF SAFETY MICROSWITCHES AND ACOUSTIC DEVICES To check that safety devices work correctly carry out the following procedure 1 Open the hatch when the instrument is turned off 2 Turn on the instrument At this point the instrument will
35. d interpretation of the message meaning that all the fields have the correct values and the checksum is correct or a NACK message to indicate that the message contains one of more errors inexact checksum incorrect length of the data field etc see paragraph 7 4 1 Rev 1 00 03 2010 52 61 NIECCE S Operating manual VE 7 8 EXAMPLE OF SERIAL PROTOCOL 1 Example for the ESR analysis request on two samples two barcodes see paragraph 7 4 1 ATTENTION The non printable characters lt 0x20 are represented with their hexadecimal value between brackets 0 Ves Matic Cube TX gt 001401500201091053 0x10 20586743 0x10 0x0D 36 HL HL HL HL HL SAMPLE 1 BAR SAMPLE 2 BAR SIX CODE CODE ETX BLK LEN ADD COM NUM CHK TERMINATOR TERMINATOR gt 9 9 9 27400 36 STX Ox3E gt H L BLK fixed value 00 H L LEN number of characters in the data field 14 hex 20 characters 2 per H L NUM 9 SAMPLE 1 BARCODE TERMINATOR 9 SAMPLE 2 BARCODE TERMINATOR H L ADD fixed value 01 H L COM command code for sample code to be processed request 50 H L NUM number of barcode included in this message 02 hex 2 bar codes SAMPLE 1 BAR CODE TERMINATOR SAMPLE 2 BAR CODE TERMINATOR ETX character OxOD H L CHK xor of all characters from STX to ETX included 2 Example of request for authorisation to Host for two barcodes
36. defined according to the following table Error code Value of L ERR H ERR Value 0x05 0x30 0x35 Field value Error H LEN L LEN Timeout on NACK Message 2 Sec 7 5 RESPONSE MESSAGE WITH COMMAND DATA After sending the ACK message the host computer must send the actual response to the message 0x50 This response will be identical to the message sent by the Ves Matic Cube 30 see paragraph 7 4 1 with the only different that the barcodes sent will only be the ones that must be processed by the Ves Matic Cube and with the further difference of the terminator 0x11 for the unknown codes i e not yet accepted on the host computer and therefore to be processed anyway Therefore the H LEN L LEN and H NUM L NUM fields may be different If none of the barcodes must be processed the Data field will only contain the H NUM L NUM 0x30 0x30 value field and H LEN L LEN will be equal to 0x30 0x32 The data field for the message code consists of the following BarCode 1 Terminator BarCode 2 Terminator BarCode n Terminator ASCII String For the ASCII string of the ASCII string of the max 15 barcode 1 max 15 Barcode 2 max 15 Barcode n characters string characters string characters string 0x10 0x1 1 0x10 0x1 1 0x10 0x1 1 H NUM L NUM Number of bar codes contained in the message represented by HEX ASCII BARCODE n ASCII string with variable length maximum of 15 characters allowed lt is the barcode that is read
37. e IT IS TOTALLY FORBIDDEN To cover the back slits fan of the instrument remove or modify the safety and protection devices 2 9 INSTALLATION PROCEDURE To unpack the instrument Control the supplied material For positioning please refer to paragraph 2 7 Remove the polyurethane block that keeps the plate still Connect the cable to the power supply satisfying point 2 8 Turn on the instrument dE E Lu Before using the instrument in the normal work cycle a series of parameters concerning the test tubes used in the laboratory must be set This type of setting must be modified Rev 1 00 03 2010 14 61 NIECCE S Operating manual VE SOLELY by an authorised Diagnostica Senese S p A technician as must be appear in the installation report supplied separately with the Installation Check Guide IN CASE OF FIRE OR GENERAL DANGER TURN OFF THE INSTRUMENT WY AND UNPLUG THE POWER CABLE 2 10 COMPOSITION OF THE MACHINE INDICATIONS FOR DISPOSAL 1 The VES MATIC cube 30 consists in percentages of IRON 20 ALUMINIUM 20 COPPER 8 EPOXY RESINS and SILICON 6 PLASTICS 45 2 to dispose of the instrument at the end of its life cycle please refer to the local laws in force on waste disposal CHAPTER 3 FUNG HONING c 15 21 _ STRUMENT lle 16 22 aaa 18 e 33 PERSONAL PROTECTION DEVICES i 18 15 61 Rev 1 00 03 2010 Operating
38. e analysed and then the next menu appears once OK has been pressed 29 61 Rev 1 00 03 2010 nireer Operating manual VES 27 300 VES30 ESS Display data o Print data o Analysis trasmission 16 59 27 04 08 0000 The operator can now decide whether to show the test results A on the screen or whether to print them E g of screen display Analisi ESR 1h Cycle Temperature Sample OK D1610860 N1609520 MDBDGSBR D1412798C M1411279 To return to the previous menu press the key ESC Rev 1 00 03 2010 30 61 Operating manual VE 4 9 INSTRUMENT SETUP MATIC 1 nireer It is possible to access a series of configurations by entering User Setup SETUP SETUP ol a lialiano Select hour English Use tha arrows to set up a Francais Press OR to store o Espanol Poriuques SETUP Lotto 000000 DNORMAL o DABHORMAL o NORMAL 25 o ABHORMAL 26 140 4 9 1 CLOCK SETUP a Clock o Qualiti C o Language o Print DC o Temp scale o Recharge CO o Setting a Working moda Temp scale Setting SETUP o Temperatura GN H DN o Display o Print o Print ravers ON WS SETUP Printing in progress Working mode SETUP Working mode ME OFF samples with barcode Recharge CO SETUP Insert CO and press DK By entering the clock from the User Setup menu it is possible to update the time
39. e paragraph 4 9 5 To enter the code the reader located inside the hatch can be used or it can be entered manually on the keypad pressing the edit key Once the code has been entered a request to insert the sample appears on the screen if connection to host applies see paragraph below Before introducing the sample in the first free position shake it twice so that the reading unit recognises the presence of the test tube and moves the plate forward one position regardless of whether the code has been entered or not Hemember that the code can only be entered before placing the sample inside the instrument Following this procedure up to sample number 30 it will be possible to move onto the next phase however if there are fewer than 30 samples to be analyses press start as soon as the last sample has been inserted to proceed with the analysis SHAKING Once the loading phase has been completed the instrument will commence the sample shaking phase The shaking phase is run by two motors The translator that turns the plate by 90 degrees and another motor that makes the plate rotate on itself During this phase which lasts for 15 minutes the blood in the test tubes is shaken in order to make sure that the red blood cells are homogeneously suspended REFERENCE READING When shaking has been completed the instrument makes a reading of each sample that checks the blood level inside the test tube Rev 1 00
40. e warranty is only acknowledged if the warranty certificate is sent within 30 days of the instrument being delivered attaching a copy of the transport documents and the installation report 2 materials and manufacture of this product shall not be considered as defective if the instrument has been adapted modified or adjusted to comply with national or local standards which differ from those for which the product has originally been designed and constructed This warranty shall not cover said adaptations modifications or adjustments or any attempts at the same irrespective of whether performed correctly or incorrectly or any damage deriving from the same 3 This warranty shall not cover periodic checks maintenance and repairs or replacement of parts due to normal wear and tear Rev 1 00 03 2010 2 61 Operating manual VE 1 3 1 4 1 5 1 6 3 61 NIECCE S transport costs and risks linked directly or indirectly to the warranty of this product including the transfer from the assistance centre to the customer s address damage due to neglect and improper use of the instrument malfunctioning of the instrument due to modifications or repairs carried out thereon by unauthorised third parties damage caused by the assembly of parts or components not approved by the manufacturer The WARRANTY CERTIFICATE is included among the APPENDIXES LIMITS OF RESPONSIBILITY DIESSE DIAGNOSTICA SENESE S
41. ematocrit Extremely high values are typical in multiple myeloma leukaemia lymphoma breast and lung carcinomas rheumatoid arthritis SLE pulmonary infarction It is high in infections of any type in carcinomas especially in the presence of liver metastasis acute and chronic inflammations Rev 1 00 03 2010 16 61 Ope 17 61 M NIECCE rating manual VES Normal ESR values Westergren citrate During the first hour ESR values are normally between 1 and 10 for men and between 1 and 15 for women in pathological conditions results can increase to values of up to 100 and higher Normal range for the instrument VES MATIC cube 30 MEN up to 10 mm hr WOMEN up to 15 mm hr Normal ESR values Westergren EDTA In general since the ESR value varies with age and gender the reference values should respect this characteristic and should be established in relation to gender and age The reference values should be established by the laboratory and in accordance with the Guidelines for the determination of the reference values Furthermore there are other clinical variables for example the level of haemoglobin some medicines the menstrual cycle pregnancy smoking that can influence ESR values and thus reflect also on the physiological reference values To evaluate the values in EDTA consult the table present in the reference document ICSH Recommendations for measurement of erythrocyte sedimentation rate J Clin Pat
42. erature of 18 setting the parameter to ON We advise the use of this function especially in laboratories O P O O with temperatures above 18 Transformation takes place according to indications from Manley bibl ref 11 In order to change it use the arrow keys to be on the temperature item and then press OK to change the parameter status Enable disable the Printer and Display settings If the Display parameter is set to off results will not appear Temperature OFI on the screen i pm i The Printer parameter allows it to be disabled if results must a Printrevers ON O 6 58 only be shown on the screen or to the host due to a temporary lack of paper in the printer or due to malfunction The Reverse printing parameter allows the direction of the test s final report printout to be set 0 1 1 00 03 2010 32 61 Operating manual VE 4 9 5 4 9 6 33 61 NIECCE eo WORKING MODE Changing the working mode also changes the instrument loading If the working mode is set to ON the instrument will request the barcode for each sample and then the introduction of each sample into the instrument if host connection applies see paragraph 4 7 If instead we set the working mode to OFF the instrument will simply ask to enter the samples inside the instrument and then to press the key OK This loading mode is much quicker but the only traceability is the position number in the pl
43. est tubes must be cleaned dried and free of any residual traces of detergent before use Supporting rack for holding the test tubes in a perfectly vertical position 19 and structured so as to be completely stable to prevent any spillage of the blood from the test tubes Procedure Dilute the blood collected in EDTA after careful though not too vigorous shaking with the citrate 109 mmol L in a proportion of 4 1 for example 2 mL of blood 0 5 mL of citrate mix the blood with the citrate carefully for a long time but not vigorously and draw up into Westergren test tubes place the test tubes in the supporting rack making sure not to expose to direct sunlight vibrations or impact after exactly 60 minutes read the distance in mm between the lower meniscus of the plasma and the level of the column of sedimented erythrocytes 61 61 Rev 1 00 03 2010
44. esult may be 0 with no error flag In this case it means that the sample in question has not been analysed as requested by the host H FLAGS L FLAGS 8 bit Bitmap of the sample errors represented in HEX ASCII The following table illustrates the errors Bit Besmpin 0 Sample High Sample tube overfled QC PASS Reserved for samples with control blood QC FAIL Reserved for samples with control blood er Reset EXAMPLES n the case of a Sample High error the Bit 0 least significant will be set to one and all the others to zero therefore the byte of the Flags will have a 0x01 hexadecimal value and its HEX ASCII representation will be 0x30 0x31 n the case of a Sample Absent error the Bit 2 will be set to one and all the others to zero therefore the byte of the Flags will have a 0x04 hexadecimal value and its HEX ASCII representation will be 0x30 0x34 Management of UNCERTAIN RESULT If a Test Tube record is sent with an ESR value equal to 0 and with an error flag active Bit 3 set to 1 the result ESR 0 must be interpreted by the Host as Sample reading error If a Test Tube record is sent with an ESR value different from 0 and with an error flag active Bit 3 set to 1 the result ESR different from 0 must be interpreted by the Host as an Uncertain Result in the report the result is printed and indicated with an asterisk RACK ID A string of 4 characters with
45. few seconds turn on the instrument again and start up the cycle in the prescribed mode Vel Rev 1 00 03 2010 NIECCE Operating manual VE CHAPTER 7 CONNECTION TO THE HOST enne senesi 43 Bi directional connections to the Host common to all Ves Cubes are commented fa below For information regarding mono directional connections see Ves Matic instrument manuals with dedicated test tubes or contact Diesse Diagnostica Senese S p a Serial Protocol for communication with the Host Computer Wy The cables used for external connections must not exceed 3 metres in length e 7 1 FOREWORD TECHNICAL 43 7 2 FOREWORD HEX ASCII REPRESENTATION i 43 e 7 3 GENERAL NOTES RESPONSE DELAYS i i 43 e 7 4 MESSAGE REQUESTING TEST TUBES TO BE PROCESSED COMMAND 0x51 44 e 7 5 RESPONSE MESSAGE WITH COMMAND DATA 46 e 7 6 RESULT SENDING MESSAGE COMMAND 0X51 47 7 7 MESSAGE OF QC SAMPLE DATA SENDING COMMAND 0X52 50 e 7 8 EXAMPLE OF SERIAL PROTOCOL 52 Rev 1 00 03 2010 42 61 NIECCE S Operating manual VE 7 1 FOREWORD TECHNICAL INFORMATION e The electric levels of the signals are the RS232C standard type e The transmission speed is 9600bit s the data format is 8 bit of data 1 stop bit and no parity bit e DB9 Female connector RS232C
46. hol 1993 46 198 203 General functioning of the instrument The blood obtained in the CBC cell blood count test tube examination is carefully mixed by the instrument the samples then remain at rest for a predetermined amount of time to allow sedimentation to occur Through the optic electronic unit the instrument automatically determines the sedimentation level of the erythrocytes subsequently the information is extrapolated and then automatically printed or shown on the display in the case of a host connection please read paragraph 7 Rev 1 00 03 2010 s NIECCE Operating manual VES 3 2 WARNINGS Ah O Y Potentially infected material is treated Abide by the EUROPEAN DIRECTIVES 89 391 89 656 EEC 89 654 EEC 89 655 EEC 90 269 EEC 90 270 EEC 90 394 EEC and 90 679 EEC Implemented in Italy in the Legislative Decree no 626 DISCONNECT the machine from the power source before any technical intervention or in the case of malfunctioning of the instrument lt is forbidden to OPERATE on the machine while any parts are moving only commands can be typed on the keyboard It is forbidden to INTRODUCE fingers and objects between the instrument s plate and protective casing 3 3 PERSONAL PROTECTION DEVICES BD Rev 1 00 03 2010 Observe personal and group safety measures foreseen for the operator and appropriate for the work environment Refer to the local laws 18 61
47. iving from the same 3 This warranty shall not cover periodic checks maintenance and repairs or replacement of parts due to normal wear and tear transport costs and risks linked directly or indirectly to the warranty of this product including the transfer from the assistance centre to the customer s address Damage due to negligence and improper use of the instrument malfunctioning of the instrument due to modifications or repairs carried out thereon by unauthorised third parties damage caused by the assembly of parts or components not approved by the manufacturer 57 61 Rev 1 00 03 2010 Operating manual VES MELE PURCHASER ADDRESS CITY MODEL REGISTRATION NUMBER DELIVERY NOTE NUMBER DELIVERY NOTE DATE DEALER ADDRESS INSTALLER ADDRESS COPY TO BE FILLED IN AND SENT TO v DESSE DIAGNOSTICA SENESE Spa Via delle Rose 10 53035 Monteriggioni Siena Italy Yin PURCHASER ADDRESS CITY ZIP MODEL REGISTRATI T ON NUMBER DELIVERY NOTE NUMBER DELIVERY NOTE DATE DEALER ADDRESS INSTALLER ADDRESS Rev 1 00 03 2010 58 61 Matic NIECCE Operating manual VE ANNEX C REQUEST FOR ASSISTANCE AUTHORISED ASSISTANCE CENTRES TO BE CONTACTED Information to specify in written requests Instrument data MODEL TYPE DATE OF PURCHASE y n warranty certificate 2 Customer data NAME ADDRESS CITY STATE ZIP 3 Dealer s data NAME ADDRESS FAULT OR BREAKDOWN FO
48. layers on the Reading Axis NO Reoding Axis x N 3 Layer _ Barcode Labe Factory Label Sq Fig 4 2 3 Rev 1 00 03 2010 22 61 Operating manual VES MESS 23 61 Filling of the test tube The level of blood in the test tube is fundamental for the correct carrying out of the ESR test by the Ves Matic Cube 30 The instrument itself will verify the correct filling of the test tube measuring the level and comparing it with the pre set tolerance values of maximum and minimum level If overfilled above 4 ml or underfilled less than 1 5 ml the instrument prints a message If the filling is excessive it signals HIGH if the filling is insufficient it signals LOW In both cases the analysis must be repeated with the correct quantity of blood The same message will appear on the results printout the volume values above refer to the use of vacutainer test tubes Rev 1 00 03 2010 eit NIECCE 4 3 TYPES OF TEST TUBES As already stated the Ves Matic Cube 30 can analyse different types of test tubes figure 4 2 2 even during the same cycle however there are limitations for rubber test tubes which require the reducer plate for processing Inserting the reducer plate Assembling dismantling the reducer above the plate is an extremely simple an operation designed to be carried out several times in a working day in laboratories that need to process different ty
49. llowing message appears on the screen during the preliminary controls WAIT Vesall Vers x xx 22 04 09 Software version of the instrument 25 61 Rev 1 00 03 2010 Operating manual VES MELE 4 5 MAIN MENU The main menu appears on the screen when the preliminary controls have been completed piers VES30 OAnalysis ESR 3 o Set up CD 35407 16 15 22 04 09 EESTI 06 0 0 0 The operations that can be carried out are contained in the main menu 3 D Resume analysis 1 Decription of Keyboard Feed to feed paper into the printer Mem to view the latest test cycles in chronological order if present in the event of a new instrument or a recently updated instrument with no stored results the message No analyses in the memory will appear and then the main menu reappears after about 2 seconds arrow keys to scroll up and down the contents of the main menu 3 OK to confirm the item selected in the main menu 3 2 Description Internal temperature of instrument CD 3852 Number of tests that can be carried out without recharging the check device see paragraph 5 4 16 58 13 04 09 System s clock and calendar Rev 1 00 03 2010 26 61 Operating manual VES MELE 4 6 27 61 3 Description of Main Menu VES30 Analysis ER Starts up an analysis cycle Set up Setup 1 e i md mand Ld Lm 4
50. ntation Rate of Human Blood Amer J Clin Pathol 1977 68 4 505 507 ICSH Guidelines on Selection of Laboratory Tests for Monitoring the Acute Phase Response J Clin Pathol 1988 41 1203 1212 Rev 1 00 03 2010 S Matic NIECCE Operating manual VE ANNEXES ANNEX A EC DECLARATION OF CONFORMITY In accordance with 98 79 EEC regulation regarding In Vitro Medical Diagnostics Devices DIESSE Diagnostica Senese S p A DIESSE DIAGNOSTICA SENESE S p A with head office in Milan Via A Solari 19 sc 6 certifies that the design type of manufacture of the in vitro medical diagnostics device described hereafter and the version distributed on the market conforms to the 88 79 EEC directive relevant to the In Vitro Medical Diagnostics Devices IVD through the accomplishment to the Annex Ill except section 6 and the essential requirements of Annex l This certificate will lose its validity in the event of modifications made to the machine in question without our authorization incorrect use of the instrument technical interventions performed by unauthorized personnel installation of non original spare parts Product Automatic instrument for ESR analysis Type VES MATIC CUBE 30 Technical data 110 120 230 Vac 56 60 Hz conforms as a whole and in its parts with the following standards and their amendments EN 61010 1 Safety requirements for electrical equipment for measurement control and
51. of the year from 01 to 12 ASCII Y Y Year of the century from 00 to 99 ASCII H VALMIN L VALMIN The minimum value of the acceptable range for the control blood represented in HEX ASCII H VALMAX L VALMAX Ihe maximum value of the acceptable range for the control blood represented in HEX ASCII QC Test Tube Record ASCII otring ASCII 4 otring characters characters characters 2 characters BARCODE ASCII string with variable length maximum of 15 characters allowed lt is the barcode that is read by the Ves Matic Cube Barcode Reader Terminator The barcodes string terminates with the 0x10 byte This is because the length of this string is variable DATA ANALYSIS String of 6 characters without DDMMYY terminator where DD day of the month from 01 to 31 ASCII MM Month of the year from 01 to 12 ASCII Y Y Year of the century from 00 to 99 ASCII ANALYSIS TIME String of 4 characters without hhmm terminator where hh hour of the day from 00 to 23 ASCII mm Minutes from 00 to 59 ASCII ESR Value of the ESR measured on the QC sample ASCII string without terminator from 0 3 Spaces 0 transmitted in the case of an error to 140 1 Space 140 If the result is higher than 140 the string will be gt 140 51 61 Rev 1 00 03 2010 m NIECCE S MoT Operating manual VE
52. out terminator identifies the sample holder rack in which the sample has been repositioned POSITION A string of 2 characters without terminator identifies the co ordinates of the position in which the sample has been repositioned in the sample holder rack 4961 Rev 1 00 03 2010 Matic NIECCE Operating manual VE H CHK L CHK CheckSum of the message represented in HEX ASCII The Checksum is calculated by carrying out the OR exclusive of all the bytes sent from STX to ETX inclusive The resulting hexadecimal value is then converted into HEX ASCII and the two characters that represent it are sent For debugging purposes it is possible to disable the checksum control replacing the byte H COM with the value 0x44 instead of 0x35 In this case the two bytes of the checksum are still sent but their value will be insignificant The Host computer must also manage any possible cases in which the checksum is disabled Heply from the Host Computer Upon receiving a message the Host computer must send an ACK message to acknowledge correct receipt and interpretation of the message meaning that all the fields have the correct values and the checksum is correct or a NACK message to indicate that the message contains one of more errors inexact checksum incorrect length of the data field etc see paragraph 7 4 2 7 7 QC QUALITY CONTROL SAMPLE DATA SENDING MESSAGE COMMAND 0X52 This message is sent by the Ves Matic Cube towards the hos
53. pes of test tubes including rubber ones Phase 1 Place the reducer on the plate so that the 3 locking pins enter the housing figure 4 3 1 and they remain with the horizontal groove according to the plate numbers Fia 4 3 1 Phase 2 Push the pin down and rotate by 90 degrees Fia 4 3 2 a Fia 4 3 2 b Phase 3 Repeat the operation for the other pins too Rev 1 00 03 2010 24 61 NIECCE S Operating manual VE Remember that the reducer disk is assembled for the use of rubber test tubes and Le that it must be removed to use vacutainer and vacuette test tubes Sarstedt test tubes are the only ones that can be inserted regardless of whether the reducer disk is in place or not 4 4 SWITCHING ON THE INSTRUMENT PROCEDURE After installing the instrument as shown in section 2 make sure the plate hatch is closed and then flip the switch on the back of the instrument to ON ON ON LL 5 BS 5 3 OFF OFF When turned on the instrument carries out an initial Reset checking the functions of all the internal units While the mechanical parts of moving the hatch is blocked closed by a Cs safety device The hatch will only be released at the end of the cycle at the end of movement or during the entry procedure used for the Identification Number with the barcode reader To open the hatch during the cycle the cycle must be interrupted by means of the specific procedure ESC key The fo
54. s neither electronic nor mechanical for any use whatsoever without prior written permission from DIESSE Diagnostica Senese S p a Printed in 2010 Total number of pages 67 INDEX a 1 INTRODUCTION ET 1 e 1 1 PRESENTATION OF 8 2 2 e Lo LIMITS OE RHESPONSIBIEISE elia 3 e 1 4 REFERENCE LEGISLATION nnnm 3 e 1 5 REQUEST FOR TECHNICAL ASSISTANCE err 3 1 6 REQUEST FOR SPARE PARTO ina rei ae 3 1 7 PRINTING 4 CHAPIERZ i cn 5 INSTALLAT TION E 5 e 2 1 GENERAL DESIGN OF THE INSTRUMENT WITH EXTERNAL CONNECTIONS E 8 e 2 3 TECHNICAL DESCRIPTION OF THE 9 e 2 4 TECHNICAL SPECIFICATIONS nnns 10 e 2 5 SUPPLIED MATERIAL 1 e 2 6 INSTRUCTIONS FOR TRANSPORT i 1 a A 0 cl Ul ii 13 e 2 8 PREPARATION REQUIRED BY THE 14 2 9 INSTALLATION PROCEDURE 14 e 2 10 COMPOSITION OF THE MACHINE INDICATIONS FOR DISPOSAL 15 CHAPTER dc f P 15 FINS o 15 dla RE NSFAVOMEN 16 3 2 WARNINGS 18 3 3 PERSONAL PROTECTION
55. sible electrical faults there may be mechanical blocks that must be reserved In the former hypothesis technical intervention is necessary Check that the test tubes are inserted correctly in the plates In addition to possible electrical faults there may be mechanical blocks that must be reserved In the former hypothesis technical intervention is necessary In addition to possible electrical faults there may be mechanical blocks that must be reserved In the former hypothesis technical intervention is necessary Insert a new Check Device If the error continues technical intervention is required Technical intervention is required 40 61 NIECCE eo Operating manual VE SAMPLE LOW This occurs during the printing phase when the Fill the test tube correctly with the same blood sample level is too low sample SAMPLE HIGH This occurs during the printing phase when the Check whether there is too much blood in the sample level is too high test tube and if so reduce the content in the test tube or check that the labels applied to the sample do not exceed the limits see paragraph 4 2 ANALYSIS ABORTED This is printed when the STOP button is pressed during the work cycle After any ERROR warning the entire operation must be repeated at least once to check m that the error is due to external causes such as interruption or temporary alteration of power voltage Turn off the instrument and wait a
56. t computer The message contains the results of the analysis performed on one or more samples The host computer must only reply to this message with an ACK or NACK type message to notify the successful receipt of the results or the presence of errors in the message Control Ves Matic Cube sends the following frame SIX H BLK L BLK H L H L ADD H L ETX H L OX3E 0x30 0x30 LEN LEN ADD 0x31 COM COM 0x0D CHK CHK 0x30 0x35 0x32 The hexadecimal values indicated in brackets are constant values for this message The fields in bold print are variable and are described below H LEN L LEN Length of the data field from Data 1 to Data n inclusive represented in HEX ASCII Maximum Value F 0x46 F 0x46 This is the effective number of bytes contained in the data field In fact the maximum number of bytes accepted in the DATA field is 255 Data 1 Data n Data Field The data field for the message code 0x52 is composed as follows QC Data QC Test Tube Record QC Data Batch No EXPIRY DATE H VALMIN L VALMIN H VALMAX L VALMAX ASCII string 6 ASCII String characters 6 characters Rev 1 00 03 2010 50 61 NIECCE S Operating manual VE BATCH No ASCII string of 6 characters Identifies the production batch of the control blood EXPIRY DATE String of 6 characters without DDMMYY terminator where DD day of the month from 01 to 31 ASCII MM Month
57. t is however necessary to follow the regulations used by the ICSH the most important of which are stated below e blood should be obtained by means of a withdrawal of the maximum duration of 30 seconds and without excessive venous stagnation e The blood can be gathered in both vacuum test tubes with EDTA as well as non vacuum test tubes with EDTA It is recalled that the Ves Matic Cube 30 uses the test tubes directly from the blood cell counter e Mix the blood immediately after the withdrawal with at least 2 complete inversions of the test tube Compatible test tubes are the ones described in figure 4 2 2 In the event that a type of test tube is used that has not been contemplated in the above examples it is possible to request a compatibility check or a modification reprogramming of the instrument by a specialised technician who has been authorised by DIESSE Diagnostica Senese SpA C If rubber test tubes are used the reducer disk must be Inserted on the plate The disk must only be used for rubber test tubes see paragraph 4 3 Fig 4 2 1 Rev 1 00 03 2010 20 61 NIECCE Operating manual VES M8552 VACUETTE VACUTAINER RUBBER SARSTEDT GREINER BIO ONE BD RUBBER CAP SARSTEDT BD TERUMO E E Y 2 Y E C Fig 4 2 2 Suitability of the sample the test is carried out within four hours of the blood being taken the test is conducted on a blood sample conserved at 4
58. the ones received from the Ves matic Cube 80 for the samples that require ESR testing i e codes that have already been accepted by the host and in the case of codes that have not yet been accepted by the host thus unknown The management of the samples to executed because they have been accepted on the host and that of the samples to be executed although unknown to the host is based on an attribute the terminator of the bar code contained in the host s reply message see 7 2 5 Example 1 WITHOUT management of unknown codes The Ves Matic Cube sends 10 barcodes to the host The host sends back only 4 of the 10 codes received i e only the ones that must be analysed by the Ves Matic Cube itself the other 6 samples are not processed by the instrument Example 2 WITH management of unknown codes The Ves Matic Cube sends 10 barcodes to the host the host sends back 4 codes with an ESR attribution to be carried out 2 codes with the attribution code unknown The instrument will execute the 6 samples at the end of the analysis it will send the results of the 4 codes with ESR to execute while the other 2 unknown codes will stay in the pending database Actually the Ves Matic Cube 30 sends one code at a time to the host but it is useful to theorise that 10 sample codes can be sent in order to be able to use the same connection for any Ves cube model Request Ves Matic Cube sends the following frame
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