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OPERATING MANUAL - DIESSE Diagnostica Senese

1. rei 85 APPENDIX B WARRANTY CERTIFICATE nnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnnennnnnennnnnennnnnennnn 87 APPENDIX C ASSISTANCE REQUEST FORM urennnennnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnennnnnennnnnennnnnennn 89 APPENDIX D ACCESSORIES SPARE PARTS AND CONSUMABLES 90 APPENDIX E REQUEST FORM FOR ACCESSORIES SPARE PARTS AND CONSUMABLES T 91 APPENDIX F METHOD MANUAL ACCORDING TO THE WESTERGREN TECHNIQUE 92 Rev 2 02 10 2009 8 VES Cus nireer Operating manual 1 CHAPTER 1 1 1 PRESENTATION OF THE INSTRUMENT 1 2 GENERAL DESCRIPTION OF THE INSTRUMENT 1 2 2 Compatibility with test tubes used for the CBC test 1 3 MATERIALS SUPPLIED WITH THE INSTRUMENT 1 4 TECHNICAL SPECIFICATIONS 1 5 TECHNICAL DESCRIPTION OF THE INSTRUMENT 1 6 INFORMATION ABOUT DISPOSAL 1 1 PRESENTATION OF THE INSTRUMENT The Ves Matic Cube 80 is a bench top instrument designed and programmed to determine the Erythrocyte Sedimentation Rate ESR with continuous and random loading of samples It is able to analyse up to a maximum of 90 blood samples every hour 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 instrument is managed by an on board touch screen PC and its functio
2. ADS ba im PH Un i oii be ES TI 721 T4 28 Tri 74 77 Bm ANTAR 200078 Ate fig 3 2 f Next page allows the display of the next pages Besides the buttons described in the previous paragraph it is possible to have information about the samples being analysed This window displays fig 3 2 f POS position of the sample in the chain ID Identification code of the sample READ1 Reading no 1 corresponding to the level of the entire column of blood after mixing This data can only be seen after typing the specific access code Access to this function is only allowed to personnel authorised by DIESSE Diagnostica Senese S p A READ2 Reading no 2 corresponding to the level of the erythrocyte column after mixing This data can only be seen after typing the specific access code Access to this function is only allowed to personnel authorised by DIESSE Diagnostica Senese S p A ESR ESR result Rev 2 02 10 2009 33 VES gt BO nireer Operating manual Search function Apri Sportello F Scarica Campioni esl ra rer ra rs rs r7 ro 2 re T gt 1 2 3 4 5 e 7 8 9 o AS Scarica Portacamp re a w e r t v u i o p L I V m a s ajrje n i k r z me z x e v b n m ue oo miw s raf dnl nen Ui I gt Archivio Impostazioni fig 3 2 g The search button allows the detection of a sample on the inside of the Ves Matic Cube 80 and the possible
3. VES 2e BO OPERATING MANUAL Software release n 2 24 Automatic professional laboratory device for the determination of the erythrocyte sedimentation rate ESR patented nireer INNOVATIVE CLINICAL DIAGNOSTIC SYSTEMS VES Cus nireer Operating manual pos MANUFACTURER 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 REPRESENTATIVE MANAGING DIRECTOR Dr Francesco Cocola REGISTERED AND ADMINISTRATIVE OFFICE Via S Vittore 36 1 20123 MILANO Italy Tel 39 02 4859121 Fax 39 02 48008530 SERVICE ASSISTANCE CUSTOMER CARE Via del Pozzo 5 53035 Monteriggioni SI Italy Tel 4439 0577 319556 Fax 4439 0577 319020 e mail customercare 2diesse it DIESSE INC 1690 W 38 Place Unit B1 Hialeah FL 33012 U S A Phone 305 827 5761 1 877 DIESSE 3 Fax 805 827 5762 e mail salesoffice diesse us ASSISTANCE SERVICE 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 2 02 10 2009 2 VES Cus nireer Operating manual 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 neit
4. e Mix the blood immediately after the withdrawal with at least 2 complete inversions of the test tube Suitability of the sample The sample can be considered suitable when e the test is conducted within 4 hours of the withdrawal e the test is conducted on a blood sample conserved at 4 for a maximum period of 24 hours In this case ensure that the sample is at room temperature before inserting it into the instrument for the analytic cycle e always turn the test tube upside down before inserting it into the instrument Attention during this manoeuvre ensure no clots are present AN ATTENTION Verify that the test tube is hermetically closed Filling of the test tube The level of blood in the test tube is fundamental for the correct conduct of the ESR examination by the Ves Matic Cube 80 instrument 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 In the case of excessive over 4 0 ml or insufficient filling less than 1 5 ml the AN instrument will print an error 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 Check of test tube labelling Sample labelling method and compatibility with the number of labels Ves Ma
5. Feb Mar 22 24 10 Caswell M Stuart J Assessment of DIESSE VES MATIC automated system for measuring erythrocyte sedimentation rate J Clin Pathol 1991 44 946 949 11 Manley R W J Clin Pathol 1957 10 354 12 ICSH Recommendation for Measurement of Erythrocyte Sedimentation Rate of Human Blood Amer J Clin Pathol 1977 68 4 505 507 13 ICSH Guidelines on Selection of Laboratory Tests for Monitoring the Acute Phase Response J Clin Pathol 1988 41 1203 1212 14 ICGH Recommendations for measurement of erythrocyte sedimentation rate J Clin Pathol 1993 46 198 203 15 How to Define and Determine Reference Intervals in the Clinical Laboratory Approved Guideline EA ASSE 2000 NCCLS Rev 2 02 10 2009 84 VES Cus nireer Operating manual APPENDIX A EC DECLARATION OF COMPLIANCE EC DECLARATION OF COMPLIANCE pursuant to the EEC 98 79 directive relating to in vitro medical diagnostic devices IVDD RIEC CE Diesse Diagnostica Senese S p A The company DIESSE DIAGNOSTICA SENESE S p A with its registered office in Milan Via san Vittore 36 1 hereby declares that the design type of manufacture of the in vitro Diagnostic Device CE IVDD described below and the version distributed on the market complies with EEC DIRECTIVE 98 79 RELATING TO IN VITRO MEDICAL DIAGNOSTIC DEVICES IVDD through the completion of Appendix III except section 6 and the essential requirements set out in Append
6. H L COM command code for sample code to process 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 the authorisation request to Host for two bar codes of two samples and the authorisation reply for the analysis of only the second see paragraph 7 2 4 ATTENTION The non printable characters 0x20 are represented with their hexadecimal value between brackets 0x Ves Matic Cube 80 TX Request 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 CODE ETX CHK TERMINATOR tetta AMEN W STX Ox3E 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 BAR CODE 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 2 02 10 2009 83 VES Cus nireer Operating manual BIBLIOGRAPHY 1 Westergren A The Technique of the red cell sedimentation reaction Am
7. 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 EXAMPLES See following table ESR value String sent Bytes of the string 0x20 0x20 0x20 0x31 Rev 2 02 10 2009 81 Operating manual VES Cus nireer LII H FLAGS L FLAGS 8 bit Bitmap of the sample errors represented in HEX ASCII The following table illustrates the errors 0 Sample High Biodcoummtoohgh 3 Sample Low Blood columntootow 2 Sample Absent Test Tube Empty 3 Abnormal Error in acquisition of height QC PASS The ESR of the QC measured is within the acceptability range QC FAIL The ESR of the QC measured is outside the acceptability range 0 ED 2 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 repre
8. 0x30 0x30 0x30 0x31 0x35 0x30 Ox0D The hexadecimal values indicated in brackets are constant values for this message The fields in bold print are variable and are described below 7 2 4 1 1 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 7 2 4 1 2 Data 1 Data n Data field The data field for the message code 0x50 is composed as follows H NUM BarCode 1 Terminator BarCode 2 Term BarCode n Term L NUM ASCII string of the ASCII string of the ASCII string of the 2 bytes max 15 Barcode 1 max 15 Barcode 2 max 15 Barcode n HEX characters string characters string characters string ASCII 0x10 0x10 0x10 Rev 2 02 10 2009 74 VES Cus nireer Operating manual H NUM L NUM Number of bar codes contained in the message represented in HEX ASCII BARCODE n ASCII string with variable length maximum of 15 characters allowed This is the barcode as it is read by the Ves Matic Cube 80 Barcode Reader Terminator Each string of the barcode is terminated with the byte 0x10 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 can contain a maximum of 255 bytes in any
9. C ASSISTANCE REQUEST FORM Modulo Segnalazione Reclamo DATA Prodotto Cliente Matricola Referente Release SW Indirizzo D D T Tel Data Fax Garanzia si No E mail ULTIMO INTERVENTO TECNICO sul prodotto Eseguito da In Data DESCRIZIONE DETTAGLIATA DEL PROBLEMA CONSIDERAZIONI VARIE DEL CLIENTE USO INTERNO Fornitura Prodotto Servizio Tecnico Tipologia di reclamo Segnalazione Uff Commerciale da inoltrare a Uff Tecnico Uff Acquisti Ass Qualit entro gg URGENTE Hitornare a Fax Tempi risposta LIE TE JEJE TEILTE IET Note Al fine di meglio comprendere e risolvere il guasto segnalato consigliamo di 1 Compilare il presente modulo in tutte le sue parti 2 Allegare al presente modulo se disponibile la documentazione fornita dal cliente es report di stampa fotografie ecc la documentazione fornita dal personale di Service es stampa dei settings reports ecc FIRMA DATA CUSTOMER CARE DIESSE Via del Pozzo 5 53035 Monteriggioni SI Italy ASSISTANCE Tel 39 0577 319556 Fax 4439 0577 319020 SERVICE e mail customercare diesse us Rev 2 02 10 2009 89 VES MRTIC Operating manual Appendix D ACCESSORIES SPARE PARTS AND CONSUMABLES i 2 Sample holder racks m 2 Micro switch keys n 1 Roll of thermal paper h mm 1257 D 50 z 2 5x20mm UL 5A delayed fuse blocks n 1 3x0 75 L 2m SCHUKO 90 C1 Power cable3 n 1 SVT PLUG USA OUTLET VDE 2MT UL Power cabl
10. Device see paragraph 3 3 Next Result indicates the waiting time for the next analytical result Temperature indicates the temperature on the inside of the instrument in C and in F Information bar shows important information such as the error code see the table in paragraph 6 1 Trouble shooting Counter of the total number of samples transferred from preparer module to analyses module indicates the total number of samples transferred from the preparer module to the analyses module To display the total number of tests conducted by the instrument during its life span it is necessary to contact a technician authorised by DIESSE Diagnostica Senese S p A Window OPEN CLOSED OPEN with red background CLOSED with green background indicates the status of the sensor present in the lid Date Time indicates date and time SW X XX indicates the Software version installed on the instrument In addition to the commands and information described in the previous paragraph it is also possible to see an online animation on the display screen of the status of the test tubes in terms of position reported to the various components of the instrument this information can also be obtained by visual observation of the various colours of the individual samples as explained in the following image Rev 2 02 10 2009 30 VES cus nireer Operating manual Q new new sample to analysed O mixed sample being mixed e NEW e
11. collection of the product contact the manufacturer or the distributor for the disposal or the redelivery of the instrument For the USA market Therefore At the end of the product lifecycle it is obligatory to carry out separate waste collection of the product contact the manufacturer or the distributor for the disposal or the redelivery of the instrument Rev 2 02 10 2009 20 Operating manual VES Cus nireer LIII 2 CHAPTER 2 2 1 PREPARATION AND CHECKS BEFORE INSTALLATION 2 2 PLACEMENT 2 3 LIMITATIONS AND WARNINGS The INSTALLATION must be carried out by a 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 2 1 PREPARATION AND CHECKS BEFORE INSTALLATION The following conditions must be ensured for the safety of the instrument and the operator The power source installation category ll must be compatible with the electrical requirements specifications and current indicated on the electric power plate supplied on the rear of the instrument it is advisable that the efficiency of the electrical system is periodically verified The network and relative outlets must be fitted with an efficient earthing connection following the laws in force on the matter of electrical systems Before connecting with ex
12. executes a reset of all internal systems Rev 2 02 10 2009 69 VES 160 nireer Operating manual 6 2 INDEPENDENT MANAGEMENT OF SOME PROBLEMS AN ATTENTION The described procedures must be carried out only while the instrument is switched off Before reactivating the instrument it is necessary to restore all safety covers 6 2 1 Procedure for access to the Classifier module 1 Remove the two Insertion Extension Racks by sliding them upwards by about 1 cm and moving them to the outside to free them from the holding buttons fig 6 2 1 a Push the Insertion Extension Racks upwards then move them outwards following the order of the arrows fig 6 2 1 a fig 6 2 1 a 2 Open the preparer module door and lift the front cover vertically about 1 cm pushing from the bottom so that it slides upwards fig 6 2 1 b 3 Completely remove the front cover Verify whether or not there are any test tubes causing a block and remove them 4 For reassembly follow the reverse procedure to the one described until the upper part of the cover is aligned with the lateral panels Rev 2 02 10 2009 70 Operating manual VES TE nireer 6 2 2 List of some error messages and their solution When the instrument is in the View Analysis Module or View Preparer module mode it can indicate error messages on the screen in the information bar see fig 3 2 b Some error messages and the operating instructions for their solution
13. instrument in C F the correction of the temperature active ON not active OFF the date DD MM YYYY or MM DD YYYY see paragraph 1 1 and the time HH MM SS of the execution of the analyses the barcodes the corresponding ESR value if the ESR value does not appear on the printout this means that the sample has not been analysed or that it is in the pending archive and the position of the sample in the sample holder rack classifier identified by a alohanumeric code POS NUM At the end of the list of samples and their related data the barcode of the sample holder rack COD SAMPLE HOLDER will appear When a control sample is analysed see paragraph 3 2 the results printout shows the following fig 3 4 a QC PASS xx xx N Lot xxxx Expiry date DD MM YY xxxxxxx QC barcode the ESR value reading for that control sample and its position in the sample holder rack To evaluate the obtained result refer to the technical instructions supplied with the control sample Rev 2 02 10 2009 51 VES MRTIC Operating manual ROCK Ok OOK CK GR OK OK CK GB CR CK GR GR OK GR GB CR CR Ck GB X DIESSE S p A ROCK Ok OOK CK GR OK CR CK GB CR CK GR GR CR GR GB GR CR GB GB X VES MATIC CUBE 80 V 2 23 SN 2007 01 00XX TEMPERATURE XX C XX F TEMPERATURE CORRECTION ON DATE DD MM YYYY MM DD YYYY TIME HH MM SS BarCode QC PASS N Lotto Xxxxx Scadenza DD MM YYYY QC ID Bar Code 5 Cl QC PASS
14. must reply to this message with a similar message containing the barcode among 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 80 sends 10 bar codes to the host the host returns only 4 of the 10 received codes that is only those that must be analyzed by the Ves Matic Cube 80 the other 6 samples will not be processed by the instrument this type of management is strongly not recommended Example 2 WITH management of unknown codes The Ves Matic Cube 80 sends 10 barcodes to the host the host returns 4 codes with the attribute ESR to execute 2 codes with the attribute unknown code 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 7 2 4 1 Reauest Ves Matic Cube 80 sends the following frame STX H BLK L BLK H LEN L LEN H ADD L ADD H COM L COM ETX H CHK L CHK Ox3E
15. paragraph Setup Menu Search allows the search for a sample within the instrument Rev 2 02 10 2009 29 Operating manual VES Met nireer View Analysis Module allows the graphical display of the processes inside the Ves Matic Cube 80 regarding the analysis module View Preparer Module Allows the graphical display of the loading unloading module processes in the rack preparer module View data allows the display of the data of the samples present in the cycle of analysis Alarm OFF deactivates the sound alarms of the instrument ID Sample holder indicates the identification number bar code of the used sample holder rack Remaininq sample holder positions indicates how many positions in the sample holder rack are still available Check Device indicates the number of tests still executable on the instrument The green colour of the window indicates that more than 1000 tests are available orange indicates availability of between 500 and 1000 executable tests yellow indicates that from O to 500 tests remain available while red indicates that the number of available tests is exhausted This leads to the automatic block of the transfer of the samples from the preparer module to the analysis module The samples already in the analysis module are nevertheless read and the relative ESR results are displayed With the test counter at O the instrument is blocked to execute other tests it will be necessary to recharge the analyser with a Check
16. possible to open the pdf files as the user manual Rear returns to the MAIN menu that is SET UP Export Files pressing this button allows for copying the following files on the SD card external memory COUNTERS INI File ERRORLOG TXT File EVENTS TXT File LOG TXT File Rev 2 02 10 2009 46 Operating manual VES engBo nireer Vescube DB File Vescube INI File The procedure is the following insert the compact flash card in the relative slot as shown in the figure 3 2 q the button Export Files will activate illuminating the command in white then press the button and await the end of operation before removing the SD card Temperature Corr ENAH HD Fig 3 2 q Service allows access by means of a password to the service menu of the instrument Only personnel authorised by DIESSE Diagnostica Senese S p A are permitted to AN access this function Rear Allows return to the MAIN MENU that is SETUP Rev 2 02 10 2009 47 VES Cus nireer Operating manual 3 3 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 DINDOR wp A VES CSE GARD IAT III i RARE orem qc nmm X0170007 E 2201 rl ir number of tests is exhausted it is necessary to reload the instrument using the special
17. samples present in the database of the Quality check archive FIND search function of samples based on barcode or date Select all immediate selection of all present samples De select all immediate de selection of all present samples Send to host sends the selected sample s to the host Eliminate eliminates the sample s selected Print print the list of the samples that are selected by means of the check box Export DB QC allows export of the Database of the QC archive in text format Arrow Up executes multiple selections of samples by scrolling up the list Arrow Down executes multiple selection of samples by scrolling down the list Exit returns to the main menu In addition to the buttons described in the previous paragraph the following information is presented Rev 2 02 10 2009 40 Operating manual VES Met nireer Number of records in the archive total number of samples present in the quality archive of the database Number of records in the list total number of samples present in the list that is displayed Error legend interpretation of the letters indicated in an error code Furthermore the following is also visible on the display screen Code barcode of the sample Host if an is present near the alphanumeric identification code of the sample this means the sample is already sent to the host Date date of analysis Time time of analysis ESR ESR result Errors error code Rack ID identification of the sam
18. that will check the presence and location of the first samples and then to the optimum position for allowing the pincers to draw out the test tubes At this point the samples are withdrawn by the pincers and placed in front of the barcode reader the samples will be turned round until the barcode can be read by the reader After the barcode reading a host query for each sample is conducted if there is a connection with a host to recognise if the identified sample requires an ESR analysis After recognising the sample the samples for which an ESR analysis has been requested will be introduced into the chain otherwise they will be placed back on the rack The samples for ESR are inserted one by one in the underlying chain of the analysis module and moved with a step time of 19 secs to the mixing zone On entering the mixing zone every sample is rotated by 120 3 times every step so after 5 steps inside the mixing zone every sample has been mixed 15 times At the exit from the mixing zone the instrument will execute the first reading for the determination of the total blood level in the sample Every test tube is then moved with a step time of 19secs to the second sensor overall time of 20 mins The instrument then executes a second reading for the determination of the level of the red blood cells after the sedimentation all data is processed and the ESR results are Rev 2 02 10 2009 54 Operating manual VES MERE nireer reported in W
19. 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 Rev 2 02 10 2009 92 Operating manual VES Met nireer Appendix G QUICK START INSTRUCTIONS Excerpt from this Operating Manual These quick start instructions are directed only to expert users with a good level of knowledge of the entire contents of this manual Turn the instrument on using the main switch situated to the left of the power cable on the back of the instrument turning it to position I fig 2 2 5 Press the START button wait for the Reset to be completed Check that the labels adhere perfectly to the test tubes the adhesive parts if detached could cause friction during the mechanical movement systems inserter ejector and sorter creating inserting and ejecting problems in the analytical chain and possible blocks of the reading Sensors Blood sample level The minimum acceptable level is 21 5 ml maximum acceptable level is lt 4 ml No special preparation of the test tubes is required since the Ves Matic Cube 80 uses the ones coming from another analytical system CBC examination it is nevertheless advisable to comply with the ICSH standards Insert the rack in its housing see figure 4 2 3c Remember that the rack loading positions are only the ones with a red interior see figure 4 2 4a The remaining positio
20. used in this document ATTENTION potential hazard of personal injuries all conditions indicated in the text must be read and understood before proceeding CAUTION potential danger of damage to the machine all conditions indicated in the text must be read and understood before proceeding N B important information BIOHAZARD danger of contamination with possibly infected materials Pd Rev 2 02 10 2009 4 VES Cus nireer LIMITATIONS AND WARNINGS Before installation and use of the instrument for proper and safe use it is advisable to read carefully the warnings and instructions contained in this user manual It is important that this user manual is stored together with the device for future reference In the event of sale or transfer make sure that this manual accompanies the Ves Matic Cube 80 to allow new users to be informed about the instrument s functions and the related warnings Use of this instrument is recommended by qualified and skilled personnel only The installation must be carried out by an authorised Diesse Diagnostica Senese S p A technician who will create an Installation Report supplied separately with the Installation Check Guide This Report must be sent to the Diesse Diagnostica Senese S p A Technical Service Department in charge to allow the effectiveness of any technical interventions and assistance after installation Operating manual It is important that this user manual is kept with the device for
21. 2009 75 Operating manual VES Cus nireer LIII General Error Checksum Error Field value Error H LEN L LEN OE ear luce Timeout on NACK Message 2 Sec 7 2 5 Reply Message with 0x50 Control Data After having sent the ACK message the host computer must send the real reply to the 0x50 message This response will be identical to the message sent by the Ves Matic Cube 80 with the only difference being that the barcodes sent will only be the ones that must be processed by the Ves matic Cube 80 and with the other difference of the terminator 0x11 for the unknown codes I e not yet accepted on the host computer and therefore also to be processed 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 0x52 message code consists of the following H NUM L BarCode 1 Terminator BarCode 2 Terminator BarCode n Terminator NUM ASCII string of the Barcode ASCII string max of the ASCII string max of the 2 bytes max 15 string 15 characters Barcode 2 15 characters Barcode n HEX characters 0x10 0x11 string string ASCII 0x10 0x11 0x10 0x11 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 This is the
22. 2009 DI VES 2 80 Operating manual n a fig 2 2 2 left side of the Ves Matic Cube 80 sample holder rack exiting fig 2 2 3 right side of the Ves Matic Cube 80 sample holder rack entering Choose a position close to an undisturbed electric socket free from electrical fluctuations Never move the instrument after it is properly installed Should movement or 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 protected from dust To move the instrument always apply the supplied handles to the instrument to move the instrument as shown in sequence fig 2 2 4 a b c fig 2 3 4 c Rev 2 02 10 2009 23 VES tue nireer Operating manual MH 7 During the movement of the analyser avoid blows and excessive inclination that could cause damage 1 Assure that the power switch is in the OFF 0 position before continuing 2 Plug connections with external instruments see paragraph 2 1 3 Install the rack insert extension as shown in the photographic sequence 4 Before connecting the instrument to the power supply make sure that the network voltage is compatible with the specifications on the registration label on the back of the instrument 9 Connect the
23. 38 64 N Lotto xxxxx Scadenza DD MM YYYY QC ID Bar Code 45 53435661 90087006 99887788 65432211 65443297 43325544 16554888 65334567 53435661 90087006 99887788 65432211 44332255 53435543 COD PORTACAMPIONI 1234 fig 3 4 a ROCK Ok OOK CK GR OOK OK CK GB CR CK GR GRO CR kK GB CR CR GB GB X DIESSE S p A ROCK Ok OK CK GR OK OK CK GB CR CR GB GRO CR GR GB CR CR GB GB X VES MATIC Em SN 2007 01 00XX TEMPERATURE XX C XX F TEMPERATURE CORRECTION ON DATE DD MM YYYY MM DD YYYY TIME HH MM SS BarCode QC PASS N Lotto Xxxxx Scadenza DD MM YYYY QC ID Bar Code Cl QC PASS 58 88 N Lotto xxxxx Scadenza DD MM YYYY QC ID Bar Code 53435661 90087006 99887788 65432211 65443297 43325544 16554888 65334567 53435661 90087006 99887788 65432211 44332255 53435543 COD PORTACAMPIONI 4321 Fig 3 4 b the modality of expression of the results is highlighted in the red circle according to the Westergren EDTA manual method mm h EDTA When a sequence of points in the ID BarCode column appears this means that the internal barcode reader did not read that barcode for that sample the position of which is indicated in the respective sample holder rack but was analysed anyway in the example of fig 3 4 a the result is displayed in B1 because there is no host connection active in the case of an active host connection see the description in 3 2 2 Archive Menu the data
24. CODE READER The recording of the identification number of the sample holder rack can only occur by means of the external BAR CODE READER supplied with the instrument GENERAL SPECIFICATIONS FOR CONNECTION Before connecting the external Barcode Reader verify that a this is fitted with a cable with a female DB9 connector in DTE configuration with a current of 5Vdc on 9 pins refer to the barcode reader instruction manual b the signals on the DB9 female connector are compatible with the connector placed on the back of the instrument to which it is connected DB9 Male External barcode SIGNAL Tx data to reader not used C TECHNICAL INFORMATION The electric levels of the signals are RS232 standard type The communication is one way from the barcode reader to the machine he transmission speed is 9600bit s the data format is 8 bit of data 1 stop bit and no parity bit The communication protocol is the ASCII type the read barcode must be finished by the Carriage return 0x0d character The reader must be connected WHILE THE INSTRUMENT IS TURNED OFF to the appropriate DB9 male placed on the back of the Window Group Rev 2 02 10 2009 72 Operating manual VES Met nireer On turning on the instrument if it is connected correctly the reader will emit an acoustic signal A similar signal is sent every time the reader obtains a barcode 7 2 CONNECTION TO THE HOST COMPUTER Serial Protocol for communication with th
25. Check Device Transponder RF test tube fig 3 3 a see paragraph 1 3 The test tube has fig 3 3 a the dimensions and appearance of a Check Device Transponter RF test tube normal one H B s H STER Ji To reload it is necessary to open the door This will allow access to the check device reloading device to the left of the mixing unit see figure 3 3b Then insert the Check Device Transponder RF inside the device see figure 3 30 MA fig 3 3 b fig 3 3 C After placing the Check Device Transponder RF test tube in the slot choose the Check Dev Procedure in the user settings fig 3 2 p After a delay of a few seconds a message will appear in the dialog bar Refill check device conducted if the outcome of the recharge is positive Error in refill check device in the case of a negative result in this case it is advisable that the operator retrieves the Check Device Transponder RF test tube and repeats the operation from the beginning At the end of the procedure the Check Device Transponder RF test tube is empty and cannot be reused It should be retrieved from the slot and disposed of in accordance with current legislation Rev 2 02 10 2009 48 Operating manual VES TE nireer Functioning of the check device A When the result of a sample is saved on the historical database and possibly printed the counter of the check device is decreased B If the instrument works without a host c
26. ITH THE INSTRUMENT The Ves Matic Cube 80 is supplied with the following materials a 1 Operating Manual in ENGLISH hard copy Ref R30600540 n 2 Sample holder racks Ref R30003650 m 2 Input extension racks Ref R10338870 a 2 Lifting handles Ref R10340531 2 V 2 Micro switch keys Ref R10345960 m 1 Roll of H mm L 57 D 50 thermal paper Ref R12300000 m 2 5x20mm UL 5A delayed fuses Ref R20400070 n 1 3x0 75 L 2m SCHUKO 90 C13 Power cable Ref R21890040 1 SVT PLUG USA OUTLET VDE 2MT UL Power cable Ref R21890370 m 1 Z 3080 Barcode reader Cable CAB50607 R9 Ref R20550510 n 1 Packing list m 1 Installation guide m 1 Warranty Card n 1 Final Inspection report Micro switch keys V 2 5x20 mm UL BA delayed fuses Barcode reader Z 3080 Cable CAB50607 3x0 75 L 2m SCHUKO 90 C13 Power cable Rack Input Extension Rev 2 02 10 2009 14 Operating manual VES ZB nireer Roll of thermal paper H mm SVT PLUG USA SOCKET VDE 2MT UL Power L 57 D 50 B Consumables that can be purchased for using the instrument y y Rev 2 02 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 hits Ref 10290 ESR Control 9 ml 2 Normal Bottles 2 Abnormal Bottles Ref 10430 ESR Control 9 ml 1 Normal Bottle 1 Abnormal Bottle Ref 10434 Thermal p
27. MPLES WITHOUT BLACKOUT FOLLOW THE PROCEDURE FROM 3 if necessary insert a sample holder rack Sample holder emptying procedure The sample holder emptying procedure allows the automatic recovery of all test tubes present in the rearrangement zone of the instrument sample holder rack for example to recover an urgent sample or in the case of an instrument block due to a forced interruption of the analytical cycle SEQUENCE OF THE OPERATIONS 1 Press the STOP button 2 Press the UNLOAD SAMPLE HOLDER button and wait for the end of the procedure Rev 2 02 10 2009 31 VES txis0 nireer Operating manual Description of the commands and information in the View Preparer module mode Vite Bed Aredia Lus Bee Propra Wat Deli eme oi e e e e e e e e 6 e e LJ NE NE NE NE NE NE LJ NE NE NE NE NE NE JA E NE NE NE NE NU JA E E E ae VES 13 06 34 2184 2008 fig 3 2 e Besides the buttons described in the previous paragraph there is also an online animation of the status load and unload racks module fig 3 2 6 Colour code of racks in View Preparer module mode Q sample tube waiting to be processed O empty position or not yet verified by the sensor analysed sample Rev 2 02 10 2009 32 VES Axis0 nireer Operating manual Description of the commands and information in View Data mode Next page PET PM MCE Vries Bee Spazi
28. Movement error along vertical axis on pincers unit If the problems persist contact technical service o obstructions can be occur that must be removed see Error in pincer inside pincer unit paragraph 6 2 If the problem persists contact technical service Device Error 0x20 Transponder Contact technical service Error of the refill device of the Check Device Error test tube absent Ph Chain Besides possible electric breakdowns mechanical obstructions can be verified that must be removed see paragraph 6 2 The system does not detect an expected test tube in the chain If the problems persist contact technical service Check Device running out Insert a new check device Transponder in the instrument The test counter is running out the instrument has no more then 500 tests available box is YELLOW If the problem persists after the refill contact technical service Check Device empty Insert a new check device Transponder in the instrument The test count has run out box is RED If the problem persists after the refill contact technical service Error in refilling Check Device Insert a new check device Transponder in the instrument Problems in refilling the test counter If the problem persists after the refill contact technical service Verify front left micro switch Verify the correct positioning of the front container on the indicated side of the micro switch Error in left micro sw
29. Rev Tuberc 1926 14 94 101 2 Silvestri M G Cozza E Bertoli G Federzoni C Marzullo F Determinazione Automatica della velocit di Eritrosedimentazione Assoc Italiana Patologi Clinici XXXIV Congresso Nazionale 1984 Abstract 3 De Franchis G 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 4 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 Sedimentaci n Globular Sangre 1988 33 6 474 478 5 Prischl F C Schwarzmeier J D Automatisierte Bestimmung der Blutkor perchensenkungsgeschwindigkeit VES MATIC Einsatz im Krankenhaus Berichte der OGKC 1988 11 112 114 6 Vatlet M Brasseur M Poplier M et al Evaluation of the DIESSE VES MATIC for the Automated Determination of the Erythrocyte Sedimentation Rate ESR Belgian Hematological Society Meeting 1989 Abstract 7 Vallespi Sole T Valor Actual de la Velocidad de Sedimentacion Globular Lab 2000 1989 19 5 14 8 Fern ndez 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 9 Koepke J A Caracappa P Johnson L The Evolution of the Erythrocyte Sedimentation Rate Methodology Labmedica 1990
30. 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 without terminator identifies the sample holder rack in which the sample has been repositioned POSITION A string of 2 characters without terminator identifies the coordinates of the position in which the sample has been repositioned in the sample holder rack 7 2 6 1 C 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 Rev 2 02 10 2009 79 VES Cus nireer Operating manual 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 7 2 6 2 Reply 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 hav
31. a Stein R TSE hee 225102008 ee d ig ttes fig 3 2 m QC settings Quality control fig 3 2 n The quality control settings window allows the set up of all parameters for the QC samples so that the Ves Matic Cube 80 can recognise them and store them separate to the normal samples To set up any QC parameter select by touching it one of the available white fields bar AN code lot number expiration date minimum value maximum value immediately the virtual Windows CE keyboard will appear for the input of the values To delete possible input errors it is sufficient to position on the right of the character that must be deleted and use the BS Rear Space button which allows deleting a character at a time EXPLANATION OF EACH SECTION Normal level area reserved for the QC parameters for a normal ESR value refer to the technical instructions supplied with the control sample Abnormal level area reserved for the QC parameters for abnormal pathological ESH value refer to the technical instructions supplied with the control sample EXPLANATION OF THE FIELDS Bar code insert bar code present on the test tube s of the QC sample s Batch num insert the batch number of the QC sample traceable on the package Expiration date insert expiry date of the QC sample traceable on the package Rev 2 02 10 2009 43 Operating manual VES Met nireer Min Value insert the minimum value obtainable with the QC sample traceable in
32. aper for printer 1 pack Ref 10403 The safety and performance requirements of the instrument can no longer be guaranteed when the instrument is powered using a different cable from the one supplied compatible with the power supply of the country of installation The safety and performance requirements of the instrument are not quaranteed whenever the instrument is used with different materials from the ones supplied and shown below External barcode reader moulded sample holder rack delayed 5A fuses 5x20 mm UL internal barcode reader programming quide 10 2009 15 VES MRTIC Operating manual nireer 1 4 TECHNICAL SPECIFICATIONS Current Europe 230Vac 50Hz USA Canada 110 120Vac 60Hz Absorbed electric power N O OT lt gt Fuses 2 X 5 0 AT Delayed 5 x 20 mm UL Dimensions Weight 650 x 580 x 690 mm Ixh xd N C1 from 15 to 35 C Room temperature Display Warehouse from 5 C to 45 C 5 C Co D Allowable relative humidity from 20 to 80 without condensation Freescale i MX31 ARM11 Microprocessor Flash 128MB NAND 128 MB DDR RAM TFT 800x 600 colour with Touch Screen Central unit Control unit peripherals Microprocessor card on owner bus Internal analytic section 89 position chain for the appropriate test tube otep progress chain 19 seconds in the normal functioning Analysed samples collection 8x14 position sample holder rack 4x14 samples to be a
33. ar view Legend fig 1 2 4 Detail of the connection panel RS232 connector for connection to the Host Computer EXTERNAL BARCODE reader connector USB HOST connector fig 1 2 4 Detail of connection panel Legend fig 1 2 5 Detail power supply box Switch I ON O OFF fig 1 2 5 Detail of power supply box Filtered outlet with fuse holder lodging Rev 2 02 10 2009 12 VES Sel nireer Operating manual 1 2 1 Compatibility with test tubes used for the CBC test VACUETTE VACUTAINER BD RUBBER SARSTEDT GREINER BIO ONE RUBBER CAP BD TERUMO E E N C 2 0 c Q fig 1 2 2 1 The Ves Matic Cube 80 is configured to use the same test tubes coming from the blood cell counter in the laboratory The compatible test tubes are those described in fig 1 2 2 1 The test tube models described in figure1 2 2 1 are substantially different in height diameter shape and dimensions of the cap but it is nevertheless possible to use different test tubes at the same time If the type of test tube being used is not displayed in the above examples it is possible to request that the instrument be programmed to make it compatible with the desired test tube type This modifie tian can only be carried out by a specialised technician authorised by DIESSE Diagnostica oenese S p A Rev 2 02 10 2009 13 VES TEBO nireer Operating manual 1 3 MATERIALS SUPPLIED W
34. ards 5 the pointer moves towards the left ww 7 invio enter fig 2 2 Rev 2 02 10 2009 17 Operating manual VES Met nireer e ACOUSTIC SIGNAL SYSTEM This functions as an alert for the operator during specific phases of the work cycle Whenever the instrument is switched on it emits a special signal each time a button on the keyboard is pressed it emits a characteristic beep and additionally to signal a problem it emits a specific alarm sound PRINTER This prints the information regarding the processed test tubes sample code ESR result contained in the sample holder rack and all useful information regarding the working cycle date hour temperature For a detailed description see paragraph 3 4 The Preparer Module consists of SAMPLE PRESENCE DETECTION UNIT The unit comprises a group of sensors that allow the machine to understand whether and where the samples are inside the rack BARCODE READING UNIT This unit carries out the barcode reading of each sample so that the instrument can execute a Host Query to differentiate the test tubes that require an ESR and thus must be inserted in the test tube holder chain The samples for which an ESR is not required can instead be placed in the rack CLAMP UNIT This unit is the connection between the preparatory module and the analysis module It comprises pincers activated by four motors that allow the transfers e The samples still to be analysed are then ta
35. barcode as it is read by the Ves Matic Cube 80 Barcode Reader Terminator Every string of the bar code is terminated by a Ox10 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 bar code string terminates with a Ox10 byte this means that the sample must be processed by the Ves Matic Cube 80 at the end of the examination the result will be printed and stored in the Historic Database If the bar code string terminates with a Ox11 byte this means the code of the sample is unknown in this case the Ves Matic Cube 80 will process the sample but at the end of the examination the result will not be printed and it will be stored in the Pending Database Rev 2 02 10 2009 76 VES Cus nireer Operating manual Timeout on Message with Data 5 Seconds 7 2 5 1 Error on Reply Message with Data If the Ves Matic Cube 80 detects an error in the receipt of the message it will repeat the transaction from the beginning and resend the request message indicated in paragraph 7 2 4 1 7 2 0 Message for sending Results 0x51 Control This message is sent from the Ves Matic Cube 80 to the host computer The message contains the results of t
36. buttons and MM set up the month using the buttons and YYYY set up the year using the buttons and Time set up time EXPLANATION OF THE FIELDS HH set the hour of the day using the buttons and MM set the minutes using the buttons and SS set the seconds using the buttons and Rev 2 02 10 2009 44 VES VEO nireer Operating manual COMMANDS of the Set up Date Time window Confirm saves the data inserted or modified Hear returns to the MAIN menu that is SET UP F F Vista Mod Analisi V ista Mod Preparat Vista Dati Apri Sportello LUICISE d ris F Scarica Campioni F Scarica Portacamp u 3 UL ILI gt Ricerca Archivio Impostazioni fig 3 2 0 Temperature corr allows the activation deactivation of the automatic temperature correction of the results when the automatic correction of the temperature is activated the relative window is coloured green and displays the writing ACTIVE when it is deactivated the window is red and shows the writing DEACTIVATED User settings fig 3 2 p DESCRIPTION OF THE FIELDS ESR MAX VAL This field allows the user based on specific needs to set up the ESR value ESR MAX VAL beyond which one desires to repeat a new analytic cycle RETRY All samples with ESR results higher than the inserted value will be automatically re analysed MAX NUM RETRY This field allows setting the number of repetitions of the analytic cy
37. by the operator are shown below Verify front left micro switch in this case it is advisable to verify the correct application of the front cover without necessarily switching off the instrument Device Error 0x04 Mixing device the normal movement of the mixer is blocked it is advisable to access the analysis module following the procedure described in 6 2 1 and 6 2 2 with the instrument turned off verify whether there are any mechanical blocks then remove the sample near the mixer switch the instrument on press Start and verify that the reset indicated in the information bar occurs correctly Error Test Tube absent Ph Chain this error may occur if the sample remains blocked in the rack caused by adherence generated by the incorrect labelling of the test tube see paragraph 4 2 2 In this case it Is sufficient to restart the analysis to move on to the next sample Rev 2 02 10 2009 71 VES Cus nireer Operating manual 7 CHAPTER 7 7 1 EXTERNAL BARCODE READER 7 2 CONNECTION TO THE HOST COMPUTER 7 2 1 Preface Technical information 7 2 2 Preface Hexadecimal ASCII HEX ASCII representation 7 2 3 General remarks Delay in replying 7 2 4 Message Requesting Test Tubes to be Processed Control 0x50 72 5 Reply Message with 0x50 Control Data 7 2 6 Message for sending Results 0x51 Control 7 2 7 Message for sending QC Quality Control sample data Control 0x52 7 2 8 Example of serial protocol 7 1 EXTERNAL BAR
38. cal service Device Error 0x04 Mixing device Besides possible electric defects there can be mechanical obstructions that should be removed see Error in mixer device of the test tube in the analysis paragraph about independent management of some module problems If the problems persist contact technical service Device Error 0x05 and 0x06 Reader 1 or 2 Besides possible electric defects there can be mechanical obstructions that should be removed see Errors in the reader devices of the optical sensors paragraph about independent management of some problems If the problems persist contact technical service Device Error 0x08 Sample holder Press the STOP button to interrupt the analysis cycle and let the rack exit by selecting Unload sample Error in the movement of the sample holder rack noder racie If the problems persist contact technical service Device Error 0x10 horizontal Pincers Besides possible electric defects there can be mechanical obstructions that should be removed see paragraph about independent management of some problems Movement error along horizontal axis on pincers unit If the problems persist contact technical service Device Error 0x11 vertical pincers Besides possible electric defects there can be Rev 2 02 10 2009 67 MATIC Operating manual VES DIESO mechanical obstructions that should be removed see paragraph about independent management of some problems
39. case the bar codes are never truncated but always complete with terminator 7 2 4 1 3 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 7 2 4 2 Reply from the Host Computer Upon receiving the message the Host computer must 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 7 2 4 2 1 ACK Message ACK H ADD L ADD ETX 0x06 0x30 0x31 Ox0D Timeout on ACK Message 2 Sec 7 2 4 2 2 NACK Message 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 defined according to the following table Error code Value of L ERR Value H ERR Rev 2 02 10
40. ch pending samples must be saved and rendered available to the operator and which ones must be removed 2 Samples with bar codes that were unable to be read will also be inserted into this archive in this case the operator must open the Pending archive to insert the missing codes this can be done with the external bar code reader or manually with the virtual Windows CE keyboard This way the devices will be able to ask authorisation to the host also for these samples The operator can force the authorisation for one or more samples manually select the sample s and push Send to host This forcing manoeuvre determines the passing of the data regarding the sample to the host the move of them from the pending archive to the historical archive and the decrease of the test counter of the check device see paragraph 3 3 If the instrument works without a host connection in this archive the samples where the barcode was unable to be read will be present Opening the pending archive the position in the sample holder rack and the result of the ESR will be displayed for these samples The relative missing codes must be inserted by the operator using the external barcode reader or manually with the virtual Windows CE keyboard as indicated in the paragraph Description of the commands and the information in the pending archive mode The Quality Check database fig 3 2 k contains the historic data regarding the results of the ESR Control samples t
41. chives of the instrument e Open the door View preparer Mod View analysis Mod View Data Alarm Off Displayed table r a TARET Vista Mod Analisi Vista Mod Preparat vista Dati Apri Sportelle Unload Rack Unload samples Sample holder emptying se ID sample holder e mixed e sedimentation e completed e Low High ET A i Remaining sample holder positions Mixing Unit F ci 2 Check Device Remaining time for obtaining next result VES Temperature Software Version 2 22 Ricerca Search pas og Setup Archivio Impostazioni zo Information Bar Boftware Release Start Stop Archive Date Hour Counter of the total number of samples fig 3 2 a transferred from the preparer module to the analyses module Rev 2 02 10 2009 27 VERS cuss nireer Operating manual Description of the commands and information common to the 3 modalities Start starts the analysis cycle The Start up command allows the initialisation of the instrument for the analytical procedures Once Start is selected it executes a Reset of the instrument after which it will be possible to insert the samples and proceed with the analysis cycle Stop his interrupts the activity of the instrument The Stop command interrupts the analytical procedures of the instrument and allows the saving of all analysed sample data At the end of a normal daily routine and before turning off the instrument it is recommend
42. cle MAX NUM RETRY regarding those samples which ESR is higher than the set value the maximum number of sample repetitions is three Rev 2 02 10 2009 45 VERS cuss nireer Operating manual nirecer Allarme OFF Scarica Campioni joi User Settings Scarica Portacamp Portacampioni ID Portacampioni Posizioni Rimanenti Check Device Prossimo Risultato Positioner Ster VF MATIC Temperatura SW 2 24 fig 3 2 p DESCRIPTION OF THE FIELDS Touch screen calibration pressing this button allows temporary adjustment of the calibration of the tabled PC The procedure to follow is guided and at the end of it the new User settings will appear The obtained calibration is only temporary and will be lost at the switch off of the analyser by the main switch Positioner step this command which should be used by expert operators only and allows rapid retrieval of a test tube from the analytical chain After opening the front panel of the instrument and inserting the appropriate micro switch key to avoid a complete stop it is possible to determine by pressing the button several times the advancement of the desired test tube up to the point in which manual access for the removal of it is allowed Check Dev Procedure This button allows you to initiate the recharge of the check device see section 3 3 External Viewer pressing this button starts up the Acrobat Reader programme with which it will be
43. d very thoroughly It is also important that the control blood at the moment of the examination is at room temperature Quality Control Test The performance of the Ves Matic Cube 80 instrument is verifiable at any moment using the ESR Quality Control The ESR Quality Control constitutes a stable material that allows the determination of the precision of the Ves Matic Cube 80 and of the total Ves Matic line for measurement of the erythrocyte sedimentation rate The expected values dependent on instrument type are reported on the illustrative page inside the ESR Quality Control pack see paragraph 0 Y For the conservation the preparation and use of the control blood refer to the illustrative page inside the packaging of the control blood Rev 2 02 10 2009 55 Operating manual VES Met nireer 4 2 2 Preparation of the sample No special preparation of the test tubes is required since the Ves Matic Cube 80 uses the test tubes from the haematology analyser CBC examination it is advisable none the less to comply with the guidelines related by the ICSH of which we cite the most important ones e he 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 80 uses the test tubes directly from the blood cell counter
44. e operator to intervene rapidly without changing the sedimentation The time passed in STOP appears in the Next result window which will be renamed STOP Time At the end of the intervention that must take less than 90 seconds it is enough to push the START button and the instrument will resume its analytical activity If the analyses cycle is re started within 90 seconds the instrument will resume the analyses of the samples present in the analytical chain and will complete the reading of the relative ESR the data corresponding to the test tubes present in the analytical chain during the Stop time are not lost and the link of the barcode of each sample with the relative position in the analytical chain is maintained to guarantee a correct correspondence between the data of the sample especially the link ID result If the analysis isn t restarted within 90 seconds the analytical run will be cancelled and after the pushing of the START button the samples present in the chain are not ejected but sent to a new analytical cycle shaking first reading sedimentation second reading and ejection without a decrease of the check device In the information bar the message Expired STOP time Analysis aborted will appear to disappear at the next Reset after pushing the Start button fig 3 2 c Archive allows access to the database of the instrument Set up allows access to the configuration menu of the instrument see
45. e z 1 Z 3080 Cable CAB50607 R9 Barcode reader Consumables Check device Transponder RF 1K for Ves Matic Cube 1000 tests Check device Transponder RF 5K for Ves Matic Cube 5000 tests Check device Transponder RF 10K for Ves Matic Cube 10000 tests ESR Control 9 ml 2 Normal Bottles 2 Abnormal Bottles ESR Control 9 ml 1 Normal Bottle 1 Abnormal Bottle Thermal paper for printer 4packets Rev 2 02 10 2009 Ref Ref Ref Ref Ref Ref Ref R30003650 H103483131 R12300000 R20400070 R21890040 R21890370 R20550510 Ref 10292 Ref 10291 Ref 10290 Ref 10430 Ref 10434 Ref 10403 90 VES Cus nireer Operating manual Appendix E REQUEST FORM for ACCESSORIES SPARE PARTS AND CONSUMABLES Fill out and send a legible copy of the following to CUSTOMER CARE DIESSE Via del Pozzo 5 53035 Monteriggioni SI Italy ASSISTANCE Tel 4439 0577 319556 Fax 4439 0577 319020 SERVICE e mail customercare diesse us Spare Parts Request Form INSTRUMENT MODEL SN 200 a I CUSTOMER COMPAN Y ADDRESS CITY ZIP CODE Remarks Code Description Requested quantity Date Signature Rev 2 02 10 2009 9 VES Cus nireer Operating manual Appendix F METHOD MANUAL ACCORDING TO THE WESTERGREN TECHNIQUE METHOD MANUAL ACCORDING TO WESTERGREN S TECHNIQUE FOR DETERMINING THE ESR In order to measure the ESR according to Westergren s technique fo
46. e Host Computer 7 2 1 Preface Technical information The electric levels of the signals are the RS232C standard type The transmission speed is 9600bit s the data format is 8 bit of data 1 stop bit and no parity bit The DB9 Male RS232C connector on the back panel of the Ves Matic Cube 80 reflects the following pin out PIN SIGNAL Rx data from Host Tx data to Host 7 2 2 Preface Hexadecimal ASCII 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 2 3 General remarks Delay in replying To allow the machine time to activate the reception mode it is necessary to enter a delay of 1 second on the reply and send the ACK frame and any reply together in a single frame Rev 2 02 10 2009 73 Operating manual VES Cus nireer LIII 7 2 4 Message Requesting Test Tubes to be Processed Control 0x50 This message is sent from the Ves Matic Cube 80 to the host computer The message contains the test tube barcode The host computer
47. e sample holder rack completely At the same time the printer will complete the printout of the results of the samples in that sample rack holder that will appear as described in fig 3 4 a and 3 4 b 2 When at the end of the day the analytical routine is completed and after having pressed the Stop button in this case the sequence of operations is the following pressing the Stop button activation and pressing the Unload sample holder which allows the sample holder rack to slide to the exit and the printout of the results regarding the samples contained in that sample holder rack which will appear as described in fig 3 4 a 3 When the samples to be analysed in the sample holder rack classifier have been completed and there is a new rack queuing up in this case the conveyor belt will move the sample holder to the exit of the Ves Cube and the printer will end the data printout on the classifier rack as described in figures 3 4a and 3 4b In any case a header will appear displaying in this order the name of DIESSE the name of the instrument the software release V X xx the writing of EDTA for results expressed in Westergren EDTA 1h units or no specification for results expressed in Westergren citrate 1h units see figs 3 4 a and 3 4 b depending on the set up selected in the laboratory at the time of installation see paragraph 1 1 the serial number of the instrument SN the temperature detected inside the
48. e 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 7 2 7 Message for sending QC Quality Control Sample Data Control 0x52 This message is sent from the Ves Matic Cube 80 to the host 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 7 2 7 1 Control Ves Matic Cube 80 sends the following frame STX H BLK L BLK H LEN L LEN H ADD L ADD H COM L COM ETX H CHK L CHK Ox3E 0x30 0x30 0x30 0x31 0x35 0x32 Ox0D The hexadecimal values indicated in brackets are constant values for this message The fields in bold print are variable and are described below 7 2 7 1 a 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 7 2 7 1 b Data 1 Data n Data Field The data field for the message code 0x52 Is composed as follows 7 2 7 1 b 1 QC Data Batch No EXPIRY DATE H VALMIN L VALMIN H VALMAX L VALMAX ASCII string 6 ASCII String charact
49. e the individual protection devices foreseen by current regulations do not take remove the covers or bypass the safety devices Samples that are not treated correctly may not guarantee a good end result Improper use and lack of or incorrect maintenance could seriously jeopardise the analytical process The safety and performance requirements of the instrument can no longer be uaranteed when the instrument is powered using a different cable from the one S upplied compatible with the power supply of the country of installation BIO CONTAMINATION HAZARDS Potentially infected material is treated When an analysis system like the Ves Matic Cube 80 is used all precautions must be taken regarding biological risks The samples do not require preparation The samples must be disposed off in accordance with the laboratory instructions and with local laws Observe personal and group safety measures planned for the operator and appropriate for the work environment Comply with the DIRECTIVES on safety matters and with the laws in force In the case of leakage of biological material during the working cycle clean external surfaces of the instrument using appropriate laboratory safety devices in order to ensure personnel safety see paragraph 5 2 All supplied materials must be disposed off in accordance with the local laws 10 2009 6 VES Cus nireer LII Operating manual INDEX T CHAPTER inssssdesnueeddudted
50. echnical intervention or in the case of malfunctioning of the instrument It is forbidden to WORK on the machine while parts are moving it is only allowed to key in commands on the touch screen and or introduce and remove racks A Limitations regarding the Check Device consumable buyable for the use of the NW instrument the instrument is provided with special Ves Check Device Transponder RF see paragraph 1 3 destined to refill the test counter Check Device of the instrument see paragraph 3 3 Using other material types can seriously jeopardise the performance of the instrument DIESSE SpA declines all responsibility on the performance of the instrument if the materials used are different from those indicated in this manual All Check Device test tubes supplied can be used only once and cannot be used again All Check Device test tubes are electronic devices and when exhausted must be disposed of according to the laws in force A When the Ves Matic Cube 80 is used all precautions regarding the biological risk must be assumed The consumables must be disposed of according to the laboratory instructions and the laws in force Observe personal and group safety measures foreseen for the operator and appropriate for the work environment Comply with the instructions in security matter and with the laws in force Potentially infected material is treated Rev 2 02 10 2009 25 VES Cus nireer Operating man
51. ed result or to repeat the analysis Verify that an air space exists between the end of the cap and the level of the sample If the level in the test tube is in fact excessive remove after mixing about 500uL of blood and repeat the test Test Tube with sample level too high exceeds 4 ml Verify the level of the sample Should this be under 1 5 ml repeat the blood sample Sample test tube with sample level too low less than 1 5 ml Rev 2 02 10 2009 53 Operating manual 4 VES Cus nireer CHAPTER 4 4 1 GENERAL DESCRIPTION OF AN ESR ANALYTICAL CYCLE IN THE VES CUBE 80 4 2 DETAILED DESCRIPTION 4 1 4 2 1 FIRST SWITCH ON 4 2 2 PREPARATION OF THE SAMPLE 4 2 3 WARNINGS AND LIMITATIONS 4 2 4 PREPARATION SEQUENCE OF A TEST 4 2 5 CONCLUSION OF THE ANALYTICAL CYCLE 4 2 6 CONCLUSION OF THE DAILY ANALYTICAL ACTIVITY GENERIC DESCRIPTION OF AN ESR ANALYTIC CYCLE IN THE VES CUBE 80 ESR Erythrocyte sedimentation rate 1h This supplies the results in accordance with the Westergren citrate method with a reading after one hour the overall duration of the analysis for the first sample is 24 minutes then the results come out every 38 seconds Description of the test cycle At the beginning of the analysis the unit queries the sensor underneath the rack pulling unit and checks that there is a sample holder present If not insertion will be requested on the information bar and it is then pulled first under the sensors
52. ed that users press the otop button in order to allow the removal of any samples still present in the classifier module and to memorise the analysis in the archive see paragraph 3 2 2 If the Stop button is pressed during the analytical cycle a request of confirmation of the stop will automatically appear on the screen with the following message STOP Analysis are you sure NO YES fig 3 2 b This avoids unwanted interruptions of the analytical cycle instrument otherwise the data regarding the last analysis cycle will not be saved inside the archives At the end of a work cycle remember to press the stop button before turning off the Uu Portacamooni n Por acarnpimi Posizioni H manl STOP Analisi Sei sicuro He Check Device Pross rit E PAL Temperatura i VES Rev 2 02 10 2009 28 Operating manual VES A180 nireer ITIL Vietie Myj Ashes kaja et Pepe ai oer Dati Allee me Orit Api Sportelio UIL dI RR A D rx n Cd np x xxu Scarica Campioni ee SEDMENTA TION TE w j scarico Folucenp xx Hi GJ dd oe ed CR du L ga tis mt LITRI LIM LI Hat DUODODOC E VES T Esaurito tempo di STOP Analisi annullata 4 11 428 27 2000 2009 Archivio fig 3 2 c Confirmation of the YES button automatically activates a stopwatch of the stop time decreasing second counter with the duration of 90 seconds This maximum interruption time allows th
53. eeeeeeees 61 o CHAPTER SA 62 51 GENERAL HEGOMMNIENDATIONR itcsusnticiirved tete rte EAS Ke e O 62 5 2 CLEANING DISINFECTION OF THE INSTRUMENT eene 62 5 3 REPLACEMENT OF PRINTER PAPER essen enne nnne 63 Bd AmBPLAGEMENTOE TIHE USES dosdeiautt mcr vento DUE eee E 65 6 CHAPTERO ili 67 6l TROUBLESHOOTING vnr 67 6 2 INDEPENDENT MANAGEMENT OF SOME PROBLEMS 70 6 2 1 Procedure for access to the Classifier module eese 70 6 2 2 List of some error messages and their SOlUtion 71 TT GMPERT an 72 VoL EXIEANVAL PARCOIE EBERT xdi CIEN 72 Rev 2 02 10 2009 7 VES Cus nireer Operating manual 7 2 CONNECTION TO THE HOST COMPUTER vv 73 7 2 1 Preface Technical information 73 7 2 2 Preface Hexadecimal ASCII HEX ASCII representation 73 7 2 3 General remarks Delay in replyin 73 7 2 4 Message Requesting Test Tubes to be Processed Control 0x50 74 7 2 5 Reply Message with 0x50 Control Data 76 7 2 6 Message for sending Results 0x51 Control ii 24 7 2 7 Message for sending QC Quality Control Sample Data Control 0x52 80 7 2 8 Example of Serial ProtocCol iii 82 l jmlelci ubge 84 APPENDIX A EC DECLARATION OF COMPLIANCE
54. er rotation direction hk E fig 5 3 b Fig 5 3 a e Connect the instrument to the power source and switch on e Push the paper until self loading begins fig 5 3 c It is possible to use a toothed roll as indicated by B figs 5 3 a b to facilitate loading Rev 2 02 10 2009 63 VES 160 nireer Operating manual fig 5 3 c e Lower the print head lever e Let the paper move forward until extending from the front figs 5 3 d e fig 5 3 d fig 5 3e fig 5 3 f e Pull the paper through close the window and extract the paper that extends from the front fig 5 3 f Rev 2 02 10 2009 64 Operating manual VES B0 nireer 5 4 REPLACEMENT OF THE FUSES When it is necessary to substitute the fuses the procedure to follow is the one described here after Make the lid of the lodging of the fuses accessible Filtered socket with fuse holder lodging fig 5 4 a which is located on the back of the instrument beneath the general power supply cable fig 5 4 a e power supply cable Filtered socket with fuse fig 5 4 b holder lodging Insert a screwdriver with a flat head in the point shown in fig 5 4 b then push the right tab to the left as indicated by the white arrow in fig 5 4 c repeat the operation with the left tab that in this case is pushed to the right as indicated by the red arrow in fig 5 4 c n fr A Jd n Rn E TUN NY him p TUS f F Wy fig 5 4 d fig 5 4 c Pressi
55. ers 6 characters BATCH No ASCII string of 6 characters Identifies the production batch of the control blood Rev 2 02 10 2009 80 Operating manual VES Met nireer EXPIRY DATE 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 H VALMIN L VALMIN The minimum value of the acceptable range for the control blood represented in HEX ASCII H VALMAX L VALMAX The maximum value of the acceptable range for the control blood represented in HEX ASCII 7 2 7 1 b 2 QC Test Tube Record Barcode Terminator ANALYSIS ANALYSIS ESR H FLAGS L FLAGS RACK ID POSITION ASCII String max of the string DATE TIME ASCII 15 characters Barcode ASCII String ASCII String String 0x10 6 characters 4 characters 4 characters BARCODE ASCII string with variable length maximum of 15 characters allowed This is the barcode as it is read by the Ves Matic Cube 80 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 YY Year of the century from 00 to 99 ASCII ANALYSIS TIME
56. estergren citrate units or Westergren EDTA units depending on the set up selected by the laboratory at the time of installation see paragraph 1 1 e he analysed test tubes are removed one by one from the chain by means of an ejection system and positioned in the green area of the sample holder rack in positions identified by alphanumeric co ordinates 4 2 DETAILED DESCRIPTION 4 2 1 Initial power up After the installation of the instrument as indicated in chapter 2 ensure that the window is closed and press the power switch situated on the left of the power cable on the back of the instrument into the ON position lt lt I gt gt At the first power up to verify the status of the instrument and the efficiency of the Optical Reading Group the following is advised e Introduce the Normal and Abnormal ESR quality control blood in two separate test tubes normally used in the laboratory position them in the racks and start an analytic cycle At the end of the test verify that the results obtained correspond to the expected values refer to in the content of the technical instructions supplied with the ESR Quality Control package Attention The blood contained in both the Normal and Abnormal ESR is an artificial control blood with particular characteristics such as consistent and resistant compression Thus to obtain the fluidity necessary to execute a correct control test it is necessary to mix the samples for a long time an
57. future reference In the case of sale or transfer make sure that this manual accompanies the Ves Matic Cube 80 to allow the new users to be informed about the instrument functionality and its related warnings The Ves Matic Cube 80 instrument must be used by qualified laboratory personnel previously trained by Diesse Diagnostica Senese S p A or by companies nominated thereby IN CASE OF FIRE OR GENERAL DANGER TURN OFF THE INSTRUMENT AND UNPLUG THE POWER CABLE DISCONNECT the machine from the power source before any technical intervention or in the case of malfunctioning of the instrument Only use finger pressure to key in the commands of the display and or the keyboard It is PROHIBITED to operate the machine while any parts are moving users are only permitted to key in commands on the keyboard ATTENTION The machine is designed to work with the door closed Rev 2 02 10 2009 5 Operating manual Rev 2 02 VES cus nireer CLAN Reagents and Consumables Any materials and or accessories supplied for the Ves Matic Cube 80 are specially designed and cannot be replaced with other types of materials or supplies Using other material types can seriously jeopardise the performance of the instrument Diesse Diagnostica Senese S p A declines all responsibility for the performance of the product if original reagents and materials are not used Before carrying out any maintenance unplug the machine from the power source us
58. he 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 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 7 2 6 1 Control Ves Matic Cube 80 sends the following frame STX H BLK L BLK H LEN L LEN H ADD L ADD H COM L COM ETX H CHK L CHK Ox3E 0x30 0x30 0x30 0x31 0x35 0x31 0x0D The hexadecimal values indicated in brackets are constant values for this message The fields in bold print are variable and are described below 7 2 6 1 a 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 7 2 6 1 b Data 1 Data n Data field The data field for the message code 0x51 is as follows H PRO L PRO Test Tube 1 Record Test Tube n Record 2 bytes HEX ASCII H PRO L PRO Number of Test Tube records contained in the message represented in HEX ASCII The Test Tube Record number contained in
59. her electronic nor mechanical for any use whatsoever without prior written permission from DIESSE DIAGNOSTICA SENESE S p A Printed in 2009 Total pages 91 ATTENTION this manual consists of 91 pages It is to be used only when complete If not DIESSE Diagnostica Senese S p A declines all responsibility It is possible to request a new copy from Servizio Customer Care Via del Pozzo 5 53035 Monteriggioni Sl Italy Tel 39 0577 319556 Fax 4439 0577 319020 e mail customercare diesse it otandards applied to the present document UNI EN 591 II Edition November 2001 IEC 61010 1 04 IEC 61010 1 04 Rev 2 02 10 2009 3 VES Cus nireer Operating manual SYMBOLS Key of graphic symbols used on the instrument European Standard EN980 2003 CE Instrument that fulfils the requirements of the European directive on in vitro diagnostic devices 98 79 EC 3 b Instrument that complies with CSA standards for the Canadian and US markets C US IVD In vitro diagnostic medical device Manufacturing date Serial number gi Key of electric and safety symbols used for the instrument Caution electrical shock danger Attention read the manual observe the symbols regarding safety WEEE Waste from Electrical and Electronic Equipment Obligation of separate waste collection according to L D 25 07 2005 no 151 Italy enforcement of the 2002 96 EC and 2003 108 EC directives gt gt A D lt of symbols
60. his database has an autonomic management regarding the other archives Rev 2 02 10 2009 36 VES gt BO nireer Operating manual Description of the commands and information in Historical archive mode ARCHIVIO STORICO codie BE Da gg mm AAAA 2210 2008 RISULTATI IN ARCHIVIO epe ent 4 Livello alto B Livello basso C Abnormal Seleziona tutti Deseleziona tutti a li U ILI gt Elimina Stampa Indietro fig 3 2 i Show All List all all samples present in the historical archive of the database are listed FIND equals an enter has the function of sample search based on the code number FIND equals an enter has the function of sample search based on the date From dd mm yy to dd mm yy the automatic presence of the current day facilitates the search of samples analysed on that date To search for samples analysed in other days it is necessary to insert in the corresponding range in which one wants to execute the search or us the code search field Select all immediate selection of all present samples De select all immediate de selection of all present samples Send to host sends the sample s selected by means of the checkbox to the host Eliminate eliminates the sample s selected Print print the list of the samples that are selected by means of the check box Arrow UP executes multiple selections of samples by scrolling the list up the list Arrow Down executes
61. itches on the front panel l l If the problem persists contact technical service Verify front right micro switch Verify the correct positioning of the front container on the indicated side of the micro switch Errors in right micro switch on the front panel l l If the problem persists contact technical service Timeout Host Verify the correct connection of the cable on the rear of the Ves Matic Cube 80 Error of connection line to host computer mE Verify the correct functioning of the IT network of the laboratory Printer out of paper Insert a new roll of paper in the printer see paragraph 5 3 Printer paper ran out l l If the problem persists contact technical service Printer head is raised Lift the lid of the printer and lower the head using the Rev 2 02 10 2009 68 VES Cus nireer Operating manual The printer head is raised black lever on the right side of the head If the problem persists contact technical service If the problem persists contact technical service Communication error between printer and PC Tablet After any ERROR signal it is advisable to repeat the whole operation at least once to ensure that the error isn t caused by external factors like the momentary interruption or variation of ls electricity Switch the instrument off and wait a few seconds turn the instrument on again and restart the cycle in the prescribed mode at the start of the analysis procedure the instrument
62. ix I This declaration shall be invalid if unauthorised modifications are made to the unit the instrument is used improperly technical interventions are made on the instrument by unauthorised staff non original spare parts are used Product Automatic system for the examination of ESR Speed Type Ves Matic Cube 80 Technical data 90 264 Vac 50 60 Hz Pwr 265VA complies in whole and in all of its parts to the following standards and related amendments EN 61010 1 Safety directives for electrical equipment for measurement control and laboratory use Part 1 General directives EN 61326 1 Electrical equipment for measurement control laboratory use EMC directives Part 1 General directives therefore meets the minimum requirements of the following EEC directives and related amendments Low voltage EEC Directive 2006 95 EEC Electromagnetic compatibility EEC Directive 89 336 EEC and 93 68 EEC Rev 2 02 10 2009 85 VES MRTIC Operating manual Monteriggioni 01 09 2005 Signature R amp D Director J Rev 2 02 10 2009 86 VES Cus nireer LIII Operating manual Appendix B WARRANTY CERTIFICATE Ves Matic Cube 80 Warranty Certificate S N Certificate 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 Ce
63. ken from the rack and brought before the barcode reader e to read the barcode and are then inserted in the test tube holder chain or placed in the rack if the specific sample does not need analysing e he analysed samples are then taken from the chain thanks to a piston that pushes the test tube outside the link to allow the pincers to grip it RACK PULLING UNIT With the help of belts positioned on the base this unit moves the sample holder rack along the module to allow the test tube transfer unit to load and unload the samples from all the rack positions The sample holder racks ejected from the instrument must be refrigerated To locate a specific sample the Ves Matic Cube 80 provides the sample code and its location coordinates in the sample holder rack which itself is identified by a specific code Rev 2 02 10 2009 18 Operating manual VES Cus nireer The Analysis module consists of POWER SUPPLY UNIT Mainly comprising 3 switching power suppliers it supplies the electricity to the various modules following a criterion for the allocation of load TEST TUBE HOLDER CHAIN The test tube holder chain consists of 89 links in which the test tubes are inserted with the help of two traction wheels the chain rotates clockwise inside the analysis module transferring the test tubes to the mixing unit and subsequently to the reading units The speed of the chain movement is controlled to allow the samples to settle for a
64. les already analysed were actually requested 4 The results regarding the test tubes requested by the host are transferred and saved in the historical archive and sent to the host The counter of the check device will be decreased in consequence The results of the samples not requested by the host will be removed from the Pending database 5 If it is not possible to re activate the connection with the host the operator can enter the Pending archive and manually force the acceptance of one or more samples the data of which must be printed right away sent to the host if possible and saved in the historical archive The check device test counter will be decreased 6 After a period of 72 hours in the Pending archive the data of the sample test tubes will be removed 7 f caused by a lack of connection to the host the instrument is unable to send the results of the accepted test tubes they are copied and memorised in the historical archive The instrument will try cyclically to send them to the host for 72 hours after which the data is only available in the historical archive 8 he operator can re send the data of one or more samples in the historical database to the host In this case the instrument will try cyclically to send the data of those samples to the host for a maximum of 72 hours E If the number of executable tests finishes during the analytical activity the instrument will save for 72 hours and in a virtual archive all da
65. ll parts exposed 1 Prepare a 1 solution of Virkon dissolve 10 g of powder in 1 litre of water in a container shaking carefully to obtain a homogenous solution For complete and detailed information of the properties of Virkon visit the internet site www virkon it Rev 2 02 10 2009 62 Operating manual VES 60 nireer ITIL 2 Use a wet cloth with the Virkon solution on the internal surfaces of the instrument that should be cleaned and decontaminated taking care to comply with the regulations in force on the matter of biological hazard Use the decontamination solution on the entire surface and carry out the cleaning operation between the electronic cards avoiding any contact therewith 3 The internal electronic cards that are contaminated by the biological samples must be substituted with newly installed equivalent cards The contaminated cards must be gathered in a plastic bag which is to be sealed and sent for disposal according to the regulations in force 5 3 REPLACEMENT OF PRINTER PAPER Procedure e Switch off the instrument and disconnect from the power source e Lift the printer window e Remove the paper pin e Substitute the old paper roll with a new one e Lift the printer head raising the appropriate lateral lever indicated with A by the arrow in figs 5 3 a and b 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 pap
66. llow the recommendations of the International Committee for Standardisation in Haematology ICSH bibliog ref 12 13 outlined below Materials Blood collected not more than three hours earlier with EDTA K2 1 5 0 25 mg per ml of blood or with 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 Anticoagulant diluting solution consisting of trisodium citrate dehydrate 109 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 test 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 1 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
67. means of the checkbox to the host Eliminate eliminates the sample s selected Arrow Up executes multiple selections of samples by scrolling up the list Arrow Down executes multiple selection of samples by scrolling down the list Exit returns to the main menu In addition to the buttons described in the previous paragraph the following information is presented Number of records in the archive total number of samples present in the Pending archive of the database Number of records in the list total number of samples present in the list that is displayed Error key interpretation of the letters indicated in an error code Rev 2 02 10 2009 39 Operating manual VES EEIBO nireer Furthermore the following is also visible on the display screen Code barcode of the sample Date date of analysis Time time of analysis Rack ID identification of the sample holder rack R Pos position in the sample holder rack identified by an alphanumeric code Description of the commands and information in Quality Check archive mode A ATTENTION As a reminder a QUALITY control sample is managed in a different manner i ARCHIVIO QUALITY CHECK Codice BE BERE eV 22 10 2008 22 10 2008 RISULTATI IN ARCHIVIO ii A Livello alto B Livello basso C Abnormal Seleziona tutti Deseleziona tutti O Ww a gt N T gt Elimina Stampa Esporta DB QC Indietro fig 3 2 k Show All List all lists all
68. multiple selection of samples by scrolling down the list Exit returns to the main menu Rev 2 02 10 2009 37 VES Cus nireer Operating manual In addition to the buttons described in the previous paragraph there is additional information available Number of records in the archive total number of samples present in the quality archive of the database Number of records in the list total number of samples present in the list that is displayed Error key interpretation of the letters indicated in an error code The following is also visible on the display screen Code code of the sample and relative check box to allow the selection of that sample Host if an is present near the alphanumeric identification code of the sample this means the sample is already sent to the host Date date of analysis Time time of analysis ESR VES result if it is 0 it means that the sample data has not been analysed on the host s request but availability is active Errors error code Rack ID identification of the sample holder rack R Pos position in the sample holder rack identified by an alphanumeric code Description of the commands and the information in pending archive mode The samples defined as PENDING refer to all those results that have not been downloaded to the host computer for example because of temporary absence of connection or that are not present in the historical archive AN ATTENTION 1 As a remi
69. muxed O sedimentation sample in sedimentation sedimentation 6 completed O completed sample analysed e f0w High Err Low High Error sample for which a problem was encountered blood level to low to high or an error for further explanations see paragraph 3 4 ru N fig 3 2 d tabella a video Open the door This allows the upper door to be opened to check for any irregularities or problems This button is only open when the cycle has not been started otherwise the button will be disabled Unload samples Once a cycle has ended pressing stop this key allows a scan to be made of the analytical chain and the unloading of test tubes to be detected If the instrument is turned off and on this button will be deactivated to activate it it will be necessary to press the start button and the stop button at the end of reset Unload sample holder ejects the sample holder rack Unload samples procedure The Unload samples procedure recovers automatically all test tubes present in the analytical zone of the instrument for example recovering an urgent sample or in the case of a forced interruption of the analytical cycle SEQUENCE OF OPERATIONS IN CASE OF FORCED INTERRUPTION OF ANALYTICAL CYCLE 1 Press the START button 2 Atthe end of the reset insert a sample holder rack in the dedicated zone fig 2 4 3 3 Press the STOP button 4 Press the UNLOAD SAMPLES button and wait for the end of the procedure IN CASE OF AN UNLOAD OF SA
70. nality will be described in more detail in the forthcoming paragraphs The analysis is carried out completely automatically mixing and reading and the results obtained in only 20 minutes are comparable to those obtained with the Westergren Reference method in 1 hour ref 1 10 The instrument is designed with the temperature correction always activated and relates the results to a temperature of 18 C according to Manley s Nomogram graph 1 1 However it is possible to de select the temperature correction for individual laboratory needs Rear Temperature p Found Corrected PI ll 435 25 75 65 Graph 1 1 Manley s Nomogram Rev 2 02 10 2009 9 VES Cus nireer Operating manual Clinical concept of the ESR The Erythrocyte Sedimentation Rate ESR is the measurement of the speed with which the erythrocytes settle The ESR value measured in a specific moment is influenced by the plasma concentration of some proteins This concentration is changed in inflammatory situations and also in the presence of certain pathologies for example some neoplasms The ESR value is also influenced by some erythrocyte properties and the haematocrit value Extremely high ESR 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 carcinoma in the presence of liver metastasis acute and chronic inflammations General f
71. nalysed and 4x14 analysed Optic groups Two couples of optic electronic elements Led amp analogical Sensor Alphanumeric with thermal paper 58 mm wide 36 characters per line speed 20 mm sec 2 x RS232C 2 USB Host 1 USB Client 1 Slot Compact Flash Protection category CLASS Safety standards CEI EN 61010 1 Ed 2001 11 CAN CSA C22 2 Nr 61010 1 04 Ed 2004 07 UL61010 1 Ed 2004 07 16 lt O vw m 2 D D 5 Q h e n D D O O gt D CEI EN 61326 Ed 2004 08 Installation category Rev 2 02 10 2009 VES S Bo Operating manual nireer 1 5 TECHNICAL DESCRIPTION OF THE INSTRUMENT The Window group consists of e PC TABLET CENTRAL UNIT Herein resides the application software that controls manages and receives data via serial connection from the single peripheral microprocessor cards where the EEPROM resides and all parameters of the instrument are memorised It is fitted with e DISPLAY This allows the display of and interaction with by means of a touch screen all the software functions e KEYBOARD The keyboard functions are carried out both using the touch screen system fig 2 1 that allows interaction with all the control software functions and with the 7 keys fig 2 2 located on the PC Tablet frame Description of the key controls 1 and 6 inactive 2 the pointer moves upwards 3 the pointer moves towards the right 5 7 3 4 the pointer moves downw
72. nder a PENDING sample if the instrument is connected to a host does not display the ESR results 2 Every time the Ves Matic Cube 80 sends a result to the host and or the historical archive the counter of the executable test is decreased visible on the Check Device window in the View Analysis Mod and the View Preparer Mod Rev 2 02 10 2009 38 VES BD nireer Operating manual ARCHIVIO PENDING Codice BI Da gg mm AAAA 292211012008 l RISULTATI IN ARCHIYIO Data gg m ID Rack Pos Rack gt B0 c Seleziona tutti Deseleziona tutti UL i gt D O D Imposta tempo permanenza record in DB ore F F F F d Aggiorna codice Leggi cod barre Sposta DB Storico Elimina Indietro fig 3 2 j Show All List all lists all samples present in the Pending archive of the database FIND search function of samples based on barcode or date Select all immediate selection of all present samples De select all immediate de selection of all present samples Update code allows the input of a barcode by means of the Windows CE keyboard in the case it is not read automatically by the instrument the keyboard will appear automatically inserting the desired bar code into the field above this command Read bar code allows the input of a bar code by means of the external bar code reader in the case It is not read by the reader inside the instrument Send to host sends the sample s selected by
73. ng the tabs between thumb and forefinger it is possible to extract the fuse holder lodging completely from the filtered socket fig 5 4 d and to proceed with the replacement of fuse s as shown in fig 5 4 e fig 5 4 e Rev 2 02 10 2009 65 Operating manual VES is nireer LIII fig 5 4 f fig 5 4 g Insert the fuse holder into its lodging fig 5 4 f pressing down in the way indicated by the arrow in fig 5 4 g until the tabs return with a click into their original position Rev 2 02 10 2009 66 VES Cus nireer Operating manual 6 CHAPTER 6 6 1 TROUBLESHOOTING 6 2 INDEPENDENT MANAGEMENT OF SOME PROBLEMS 6 2 1 Procedure for access to the Classifier Module 6 2 2 List of some error messages and their solution 6 1 TROUBLESHOOTING The PC Tablet besides performing command operations and control of the peripherals constantly checks the most important parts of the instrument When an anomaly is encountered the process in progress is automatically interrupted and a sound signal is sent at the same time the type of breakdown or problem encountered is displayed on the Screen The possible messages are the following MESSAGE AND FAULT CAUSE AND SOLUTION Device Error 0x01 Positioner Besides possible electric defects there can be Error of the chain movement mechanical obstructions that should be removed see paragraph about independent management of some problems If the problems persist contact techni
74. ns are used by the machine to unload the analysed samples Once the rack has been inserted type the relative barcode Press the STOP button to interrupt the analysis ATTENTION Do not switch off the instrument during the working phases or during the Reset procedure To safeguard the database it is advisable that the machine is switched off ONLY after pushing the STOP button on the display awaiting completion of the movements At the end of the daily analytical activity and every time access to the archive is required it is necessary to press the Stop button This activates illuminates the Archive button and at the same time saves all data obtained until that moment t is advisable to press the Stop button ALWAYS before turning the main switch of the instrument off see paragraph 3 2 1 description of the Stop button function Rev 2 02 10 2009 93 DIESSE Diagnostica Senese SpA Via del Pozzo 5 Loc S Martino 53035 Monteriggioni SI Italy Tel 39 0577 31 95 60 61 50 Fax 39 0577 31 87 63 http www diesse it e mail salesoffice diesse it
75. ntre indicated to you at the time of delivery of the instrument Limits of liability DIESSE DIAGNOSTICA SENESE S 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 General warranty regulations DIESSE DIAGNOSTICA SENESE S p A guarantees the Ves Matic Cube 80 for a period of 12 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 for transport costs General Conditions The warranty shall only be acknowledged if the warranty certificate is sent within 30 days of the delivery date attaching a copy of the transport documents thereto The 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 in force in a country where they 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 This warranty shall not cover ariodic checks maintenance and repair
76. of its Ad stated in the appropriate instructions described in paragraph 5 2 5 2 CLEANING DISINFECTION OF THE INSTRUMENT Attention to carry out this procedure use the devices foreseen in the legislation in force for handling a biological hazard Cleaning and decontamination of the external surfaces of the instrument 1 All described operations must be conducted with the instrument switched off 2 Prepare a 1 solution of Virkon registered trade mark in a container 10 g of powder in 1 litre of water Dissolve the powder by shaking the container until the solution is homogeneous For complete and detailed information on the properties of Virkon visit the internet site www virkon it 3 Use a wet cloth with the Virkon solution on the external surfaces of the instrument that should be cleaned and decontaminated taking care to comply with the regulations in force on the matter of biological hazard Use the decontamination solution on the entire surface and clean while avoiding any contact with the internal parts of the instrument containing the electronic cards 4 Leave to dry Repeat the operations described in points 2 and 3 to conclude the cleaning and decontamination of the external surfaces of the instrument Cleaning and decontamination of the internal parts of the instrument All operations must be conducted only by personnel authorised by Diesse Diagnostica Senese S p A and must be done with the instrument turned off and with a
77. onnection all results are saved on the historical database printed displayed and the counter of the check device is decreased for each one The results regarding samples with a illegible bar code are saved in the pending archive see Pending Archive in 3 2 2 C If the instrument is configured to work connected to a host only the samples for which the host computer has requested an analysis will be analysed then the results are printed displayed saved on the historical archive and sent to the host and consequently the counter of the check device is decreased All the others will not be analysed however if a request for sample traceability is made the unanalysed samples will be shown in the printout in the archive and on the host which will obviously not decrease the test counter D In the case of a temporary absence of a host connection the instruments proceeds as follows 1 The test tubes will all be processed and the data saved temporarily 72 hours in the Pending database The data of these test tubes is all displayed except the analytical result 2 At the time of the positioning of the test tube in the sample holder rack only the barcode and the position of the test tube in the sample holder rack will be printed the result of the analysis will not be printed 3 Atthe end of the analytical cycle the instrument at regular intervals and for a maximum of 72 hours will continue to interview the host to establish which pending samp
78. period of 20 minutes before the final reading is carried out MIXING UNIT This is the unit in charge of the inclination and 120 rotation of the test tube holder chain for 5 test tubes to guarantee the homogenous mixing of the red blood cells HEADING UNITS 1 amp 2 In each unit a motor lifts the reading unit that with the help of an optical sensor verifies the suitability of the sample contained in the test tube and detects the level of sedimentation TEMPERATURE SENSOR This measures the temperature inside the instrument and is positioned in the analysis module The value of the temperature is visible in the temperature window on the display EJECTOR UNIT This comprises a piston that pushes the test tube outside the chain in order to be picked up by the pincers that will place it in the sample holder rack Rev 2 02 10 2009 19 VES Cus nireer Operating manual 1 6 INFORMATION REGARDING DISPOSAL The Ves Matic Cube 80 instrument relies on the use of an electrical power source and therefore in compliance with European Directive 2002 96 EC of 27 January 2003 and later amendments by the European parliament it is classified as Electrical Electronic Equipment L D 25 07 2005 no 151 Italy Therefore Disposal of the device in the normal solid urban waste is strictly prohibited by law Doing so could incur legal penalties against the violator At the end of the product lifecycle it is obligatory to carry out separate waste
79. ple holder rack R Pos Position of sample in the sample holder rack identified by an alphanumeric code Batch num the lot number of the QC sample Exp date expiry date of the QC sample Min Val the minimum value obtainable with the QC sample Max Val the maximum value obtainable with the QC sample Rev 2 02 10 2009 41 VES T 180 Operating manual 3 2 3 Setup Menu Description of the commands and information of the Setup menu Vries GENE TI EET Verte bed eau i Viris Mali Te t i aTa e e one ia en La Le n lee ere ee aee Sr Del Link al Li Yi M I Indietro Archivio fig 3 2 1 This function allows access to some update and service procedures fig 3 2 1 Language QC Setting SW Update Date time Temperature Correction User Settings Service Language allows the language to be selected in fact by typing this command the following window appears Select language fig 3 2 m To set the selected language in the instrument press the corresponding button on the display Rev 2 02 10 2009 42 VES 160 nireer Operating manual F F Vista Mod Analisi Vista Mod Preparat Prossima pa Apri Sportello LICOSE E pus Miis Pos fio freaDi mEaD2 le I Select language scarica Campioni F a B Italiano Scarica Portacamp IL DS gt English Espanol Deutsch Francais U UL LLI gt 2350 7437 ans 04 f i F 11 07 40 n r Archivio Impostazioni Ricerc
80. recovery of it by insertion of its bar code number fig 3 2 g using the keyboard and pressing the OK button The OK button is replaced by the buttons YES and NO to provide the ability to respond to the proposed option regarding the removal of the sample Removal of the sample Pressing the YES button will start the recover sample procedure A ATTENTION The sample recovery procedure will interrupt the analysis cycle Rev 2 02 10 2009 34 Operating manual VES B0 nireer 3 22 Archive menu Choosing the ARCHIVE command in the main menu the functions of the ARCHIVE Menu are accessed Historical DB allows access to the historical archive of the samples present in the database Pending DB allows access to the archive of the pending samples present in the database The pending samples are those that are not yet sent by the Host nor saved in the historical archive Quality Check DB allows access to the historical archive of the Quality Control samples present in the database Rear returns to the Main Menu F F vista Mod Analisi Vista Mod Preparat Vista Dati Apri Sportello UILJ L Scarica Campioni Scarica Portacamp sedimentation DB Pending completed e Low High Err r DB QualityCheck Indietro a j Ui i gt Ricerca Archivio Impostazioni fig 3 2 h DATABASE ARCHIVE There are 3 archives fig 3 2 h The historical database fig 3 2 i stores up
81. red as indicative and vary depending on age and gender 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 Rev 2 02 10 2009 10 Operating manual VES EEIBO nireer values in EDTA consult the table present in the reference document ICSH Recommendations for measurement of erythrocyte sedimentation rate J Clin Pathol 1993 46 198 203 1 2 GENERAL DESCRIPTION OF THE INSTRUMENT Legend fig 1 2 1 front view closed Instrument control unit with display equipped with Touch Screen PC Tablet Printer Rack introduction compartment Fig 1 2 1 front view closed Legend fig 1 2 2 front view open Sample rack introduction compartment mixer Sample tube withdrawal clamp Fig 1 2 2 front view open Rev 2 02 10 2009 11 Operating manual VES cus nireer LIII Legend fig 1 2 3 Rear View External connections panel Power supply box fig 1 2 3 Re
82. regarding this sample is stored in the Pending Archive At this point the operator can continue as described in 3 2 2 Archive Menu Historic DB and Pending DB Rev 2 02 10 2009 52 Operating manual VES TE nireer The following messages may be shown in the WEST 1H column referring to the results expressed in Westergren citrate units as well as those expressed in Westergren EDTA units ERR means that the instrument has not been able to reveal any characteristic point useful for the readings thus it is advisable to check the sample and after excluding labelling problems clots etc to repeat the analysis LOW means that the quality of blood of the sample is insufficient s than 1 5 ml Verify the level of the sample should this be lower than 1 5 ml repeat the blood sample HIGH means that the quantity of blood of the sample is excessive 4 ml Verify that an air space exists between the end of the cap and the sample level If the level of the test tube is in fact excessive remove after mixing about 500 ul of blood and repeat the test XX value of ESR with an asterisk for example 43 as in fig 3 4 a means that the instrument has read a value but advises the operator that the state of the sample does not correspond to that specified in 4 2 2 figs 4 2 2a 4 2 2 b 4 2 2 c The operator is advised to check the sample to exclude labelling problems clots etc and decide whether to validate the obtain
83. s or replacement of parts due to normal wear and tear ansport costs and risks linked directly or indirectly to the warranty of this product including the transfer from the assistance centre to the customers address damage deriving from erroneous use negligence during use erroneous installation knocks and falls Unsuitable voltage connections use in environments with extreme conditions damage caused by liquids being spilt inside etc or from any other accidental cause nalfunctioning 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 No interventions carried out under warranty shall interrupt or prolong the duration thereof for any reason whatsoever Rev 2 02 10 2009 87 Operating manual VES Cus nireer LIII niECCE DIESSE DIAGNOSTICA SENESE S p A Tel 0577 58 71 11 VIA DELLE ROSE 10 53035 MONTERIGGIONI SIENA ITALY Fax 0577 31 86 90 Ves Matic Cube 80 Warranty Certificate S N Certificate DEN DIESSE DIAGNOSTICA SENESE S p A Copy to be FILLED OUT and RETURNED to Via delle Rose 10 53035 Monteriggioni Siena Italy S N Certificate DENS INSTRUMENT MODEL SN 200 II CUSTOMER COMPANY ADDRESS CITY ZIP CODE DEALER S NAME COMPANY DATA ADDRESS INSTALLER S NAME COMPANY DATA ADDRESS Remarks Rev 2 02 10 2009 88 Operating manual VES cus nireer LIII Appendix
84. sentation 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 7 2 7 2 Reply 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 7 2 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 Ox Ves Matic Cube 80 TX gt 001401500201091053 0x10 20586743 0x10 0x0D 36 Rev 2 02 10 2009 82 VES Cus nireer Operating manual SAMPLE 1 BAR SAMPLE 2 BAR CODE CODE TERMINATOR TERMINATOR CEU OW S 9 8 mons anno 00 3 STX 0x3E gt H L BLK fixed value 00 H L LEN number of characters in the data field 14 hex 20 characters 2 for H L NUM 9 SAMPLE 1 BARCODE TERMINATOR 9 SAMPLE CODE 2 BARCODE TERMINATOR H L ADD fixed value 01
85. socket on the power cable use the cable that is supplied with the instrument to the plug on the right side of the general power switch on the instrument itself as shown in fig 2 2 5 and 2 1 5 Connect the plug of the power cable to the power source fig 2 2 5 6 Turn the instrument on by the general switch on the back of the instrument to position I fig 2 2 5 7 To execute a test cycle and subsequently an analytical cycle check chapter 4 of this manual Also after a long period of not using the instrument it is advisable to contact technical assistance to verify the good functioning 8 lest cycle Insert a rack with at least 5 labelled test tubes and start the analytical procedure Check that the instrument executes the initial reset in a correct manner that the procedure finishes correctly without interruptions that the barcodes attached to the processed test tubes have been acquired by the instrument correctly the print concerning the conducted analytical cycle facilitates this verification operation Rev 2 02 10 2009 24 Operating manual VES Met nireer AN Remember that the test tubes to be analysed must be inserted into the red part of the rack as the green part is used by the instrument to unload the samples already analysed 2 3 LIMITATIONS AND WARNINGS MI IN CASE OF FIRE OR GENERAL DANGER TURN OFF THE INSTRUMENT AND UNPLUG THE POWER CABLE DISCONNECT the machine from the power source before any t
86. st be turned off ONLY after pressing the STOP button on the W display and waiting for the movement to end Rev 2 02 10 2009 59 VES aB nireer A Operating manual ATTENTION If an analysis is carried out using just a few samples it is worthwhile filling the free rows to the left of the rack in the red area only Do not switch off the instrument during the working phases or during the Reset procedure To safeguard the database it is advisable that the instrument is turned off ONLY after pushing the STOP button on the display and awaiting the completion of the movement fig 4 2 4 a Rev 2 02 10 2009 60 Operating manual VES TEbBO nireer ITIL 4 2 4 Preparation sequence for a test Loading procedure of the samples a Press the START button wait for the Reset to be completed b Insert the rack in its housing visible in fig 4 2 4 b c Insert the relative bar code with the external barcode reader or using the virtual Windows CE keyboard pressing the grey button Classifier ID fig 4 2 4 b 4 2 5 Conclusion of the analytical cycle An analytical cycle regarding a single sample is finished when 1 the sample is present and identifiable by the corresponding alphanumeric co ordinates in the sample holder rack that holds it 2 the relative result is present on the result printout regarding the sample holder rack that holds it Every time a sample holder rack is complete the instrument will comple
87. t Bytes of the string 0x20 0x20 0x20 0x31 N B If sample holder rack traceability has been activated the ESR result may be 0 without error flag in this case it means that the sample in question has not been analysed as requested by the host Rev 2 02 10 2009 78 VES Cus nireer Operating manual H FLAGS L FLAGS Bitmap with 8 bit 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 M QC PASS Reserved for samples with control blood 4 QC FAIL Reserved for samples with control blood 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 for non analysed samples the error flag is not active further to a host request If a
88. ta regarding the analysed samples up to a Rev 2 02 10 2009 49 Operating manual VES Cus nireer LIII maximum of 3 000 items the relative results will not be displayed until the test counter is reloaded This temporary saving 72 hours allows analyses to be completed the data on analysed samples not to be lost and therefore to avoid repeating the analysis and provide the laboratory enough time to organise a new transponder to reload the test counter The number of the tests available in the instrument is indicated in the dedicated window fig 3 2 b its colour informs the user of the remaining tests available green indicates the possibility of analysing more than 1000 tests orange indicates that the number of available tests is between 500 and 1000 yellow indicates that the tests available are less than 500 while the red indicates the number of executable tests is exhausted Rev 2 02 10 2009 50 VES Cus nireer Operating manual 3 4 GUIDED READING OF THE RESULTS PRINTOUT The Ves Matic Cube 80 prints the results of each sample in real time The printout complete with header of the results regarding the samples in a sample holder rack classifier is obtained in two cases 1 when the sample holder rack classifier is complete In this case the instrument will slide the sample holder rack automatically up to the exit positioned at the lower left side of the instrument fig 2 2 2 from this position it is possible to extract th
89. te a printout of the results regarding the test tubes of the samples therein also indicated on the printout is the code of the sample holder rack the date the time and the temperature of the analytical cycle the installed software version and the serial number of the instrument paragraph 3 4 4 2 6 Conclusion of the daily analytic activity At the end of the daily analytical activity and every time one desires to access the archive it is necessary to press the Stop button This operation allows the Archive button to become active illuminated and at the same time to save all data obtained until that moment Before turning off the instrument s main switch ALWAYS press STOP otherwise the data saving in the archive will be jeopardised Rev 2 02 10 2009 61 Operating manual VES Met nireer 5 CHAPTER 5 5 1 GENERAL RECOMMENDATIONS 5 2 CLEANING DISINFEC TION OF THE INSTRUMENT 5 8 REPLACING PRINTER PAPER 5 4 REPLACEMENT OF THE FUSES 5 1 GENERAL RECOMMENDATIONS The Ves Matic Cube 80 is designed and constructed to require only a minimum amount of maintenance For any intervention V disconnect the power from the instrument v1 usethe personal protection features foreseen during functioning do not remove barriers and do not avoid the security devices external surfaces use the features provided for decontamination and carry out the actions In the case of leakage of biological material inside the instrument or contamination
90. ternal instruments host PC external Barcode Reader always A remember to do this while the instrument is switched off 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 Connection with an external PC is possible with specific software Microsoft ActiveSync 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 consumables used cleaning and disinfectant solutions for the cleaning and the Items for the security and safety of the operator gloves container for the disposal of the disinfection of the instrument see paragraph 5 2 should always be available The location of the instrument should follow the guidelines indicated in paragraph 2 2 MI ITIS TOTALLY PROHIBITED to remove or modify the safety and protection devices of the instrument Rev 2 02 10 2009 21 Operating manual VES Bo nireer LIII 2 2 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 Ves Matic Cube 80 has been man
91. the data field is limited by the fact 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 Rev 2 02 10 2009 77 Operating manual VES Cus nireer LIII 7 2 6 1 b 1 Test Tube record Barcode Terminator DATA ANALYSIS ANALYSIS ASCII string of the ASCII String TIME max 15 Barcode 6 characters ASCII String characters string 4 characters 0x10 characters characters BARCODE ASCII string with variable length maximum of 15 characters allowed This is the barcode as it is read by the Ves Matic Cube 80 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 YY 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 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 EXAMPLES See following table ESR value String sen
92. the technical instructions Max Value insert the maximum value obtainable with the QC sample traceable in the technical instructions COMMANDS in the Quality Control set up window Confirm saves the data inserted and or modified Rear returns to the main menu that is SET UP fig 3 2 n oelect one of the available white fields to set up any parameter the virtual Windows CE keyboard will appear immediately for the input of the values To delete possible input errors it is sufficient to position on the right of the character that must be deleted and use the BS Rear opace button which allows the deletion of a character at a time To complete the information on the Quality Control please read paragraph 3 4 of this manual and the technical instructions supplied with the control sample Date time allows the select the format of the date and to set Date and Time of the system Pressing this button the Set Date Time window will appear fig 3 2 0 EXPLANATION OF EACH SECTION Date oet up date format DD MMYyY Y Y Y format with day month year MM DD Y Y Y Y format with month day year To complete the selection of the date format confirm the operation using the specific confirm button return to View Analysis Module turn off and turn back on the main instrument switch After this operation the date will be displayed in the selected format Set up of the Date EXPLANATION OF THE FIELDS DD set up the day using the
93. tic Cube 80 models are designed to work with a maximum of two labels not overlapping attached to the same test tube to be analysed Fig 4 2 2 a The internal barcode reader inside the preparer module is mechanically regulated to work with labels applied to the sample at least 3 mm above the rounded bottom of the test tube Fig 4 2 2 Rev 2 02 10 2009 56 Operating manual VES EN nirecr LLL a it is also programmed to read barcodes placed at 90 from the reading band i e with the code perpendicular to the longitudinal axis of the test tube Fig 4 2 2 a The reader nevertheless can correctly read sloping barcodes corrected by 5 fig 4 2 2 a BOK Barcode Label _7 Barcode Label i AE Positioning Min 3mm a 2 Mox LL Fig 4 2 2 a Correct height of application of the label on the test tube The reading group sensors are able to detect correctly the sedimentation rate inside each sample following the reading axis reading through a maximum of three layers of paper Thus only two labels at most are attached to the test tube which must be staggered with each other by least 90 degrees fig 4 2 2 b Reading Axis Reading Axis BOK Light Receiver EL ON 3 Layer Barcode Label Ch 2 Layer Factory Label Light Emitter Tube cross section 1 Layer Max 3 layers on the Reading Axis Fig 4 2 2 b Maximum number of label layers a
94. to a maximum of 10 000 samples managed in a scrolling mode Only those samples for which the host computer or the operator has authorised the analysis will be saved in this archive It will be possible to see print and send the results to the host only for these The check device counter will be reduced only for these results The samples sent to the host will be highlighted in the display page of this database with an asterisk The information code and position inside the sample holder about samples on which ESR tests will not be carried out which for these samples will be O will be printed saved in the historical database and sent to the host this intervention on configuration software is only allowed by technicians authorised by DIESSE Diagnostica Senese S p A It is also possible to set availability of each sample in the Service menu during installation further to the client s request Rev 2 02 10 2009 35 VES Cus nireer Operating manual The Pending database fig 3 2 j stores 1 The samples already processed that have not yet received authorisation from the host to execute their analysis The results of these samples cannot be displayed The presence of a sample in this database is limited to 72 hours the date time field of the sample itself is considered as the beginning after which all information about the sample will be removed The device during the stand by period will try to communicate with the host to know whi
95. ttached to test tube and accepted by the Ves Matic Cube 200 It is important to verify before loading the instrument that the labels adhere perfectly to the AN test tubes the adhesive parts if detached can cause frictions during the mechanical movements of the groups inserter ejector and sorter creating inserting and ejecting problems in the analytical chain and possible blocks of the reading sensors In fig 4 2 2c some INCORRECT labelling examples are displayed which are potential causes of mechanical blocks and or reading problems on the Optic Electronic Sensors Rev 2 02 10 2009 57 VES MATIC Operating manual NO Reading Axis N N N Barcode Label Fig 4 2 2 c INCORRECT sample labelling modes Rev 2 02 10 2009 08 VES BD Operating manual nireer 4 2 3 Warnings and limitations Insert the samples to be analysed in the red area only of the sample holder rack and 1 insertthe rack in the right side of the ves cube along the extension see photo n RR VES tice O ES cU fig 4 2 3 a fig 4 2 3 b left side fig 4 2 3 c right side There is a rack loading extension on the left side of the instrument for the exiting sample holder racks containing the analysed samples fig 4 2 3 b The sample holder rack slides from right to left Do not switch off the instrument during the working phases or during the Reset procedure Nn The machine mu
96. uMu va Eus ga cca 1 1 PRESENTATION OF THE INSTRUMENT serseriye n 9 1 2 GENERAL DESCRIPTION OF THE INSTRUMENT eee 11 1 2 1 Compatibility with test tubes used for the CBC test 13 1 3 MATERIALS SUPPLIED WITH THE INSTRUMENT eer 14 L4 TEGCHNIOAEBSPESIBIOATIONSOS sccitstiensto bench rae imn mn SER Una 16 1 5 TECHNICAL DESCRIPTION OF THE INSTRUMENT eee 17 1 6 INFORMATION REGARDING DISPOSAL essere 20 2 GER 21 2 1 PREPARATION AND CHECKS BEFORE INSTALLATION ll 21 22 PLACEMENT Lecca ra 22 23 LIMIEFATIONS ANDWARNINGS aaa 25 3 CHAPTERS O Eta 26 3 1 SWITCHING ON THE INSTRUMENT essen nnns 26 3 2 DESCRIPTION OF THE SOFTWARE li 27 3 2 1 Vire MONU RENTRER m 27 EAN 35 gt EE EUR 42 2o CHEO DEVIE EE n HUM 48 3 4 GUIDED READING OF THE RESULTS PRINTOUT enm 51 EC uj c 54 4 1 GENERIC DESCRIPTION OF AN ESR ANALYTIC CYCLE IN THE VES CUBE 80 54 422 DET VED PES PINNE 55 4 2 1 La EL PONCE EEE 55 4 2 2 reparation or the SaTblQ ecsiecerueieedestitdess AE E tret bu bue its et E ns Unies UR iet Queue 56 4 2 9 Warnings and limitations sassanidene 59 4 2 4 Preparation sequence for a test 61 4 2 5 Conclusion of the analytical CyCle 61 4 2 6 Conclusion of the daily analytic activity ccc ccccsseceeesseeeeesseeeesss
97. ual 3 CHAPTER 3 3 1 SWITCHING ON THE INSTRUMENT 3 2 DESCRIPTION OF THE SOFTWAHE 3 2 1 MAIN MENU 3 2 2 ARCHIVE MENU 3 2 3 SETUP MENU 3 3 CHECK DEVICE 3 4 GUIDED READING OF THE RESULTS PRINTOUT 3 1 SWITCHING ON THE INSTRUMENT Switching on After verification of the installation of the instrument as described in chapter 2 make sure the window is closed and move the power switch situated on the left of the power cable on the back of the instrument to the on position I fig 2 5 Start up of system Once switched on push the Start button the instrument executes an initial Check Reset This operation is essential and allows for verification of the proper functioning of all internal units and check that the moving parts are in the correct positions During the initial check when the instrument is switched on the Software Version cz installed and subsequently the indications RESET IN PROGRESS are shown on the 57 display Rev 2 02 10 2009 26 VES 160 nireer ITIL Operating manual 3 2 DESCRIPTION OF THE SOFTWARE 3 2 1 Main menu From the Main Menu fig 3 2 a using the function buttons it is possible to e Start the analysis with the Ves Matic Cube 80 e Access the service menu e Modify the display mode for example View Analysis View analysis Mod Preparatory mode Data View e Unload samples that remain in the analytical chain of the Analyses Module e Unload the sample holder rack e Access the ar
98. ufactured to conform to the electromagnetic emissions directives however it is nevertheless advised that whenever possible the Ves Matic Cube 80 is placed far from possible generators of electromagnetic waves for example fridges laboratory centrifuges and from instrumentation without CE labelling as they could occasionally interfere with the functioning of the instrument It is advisable that a bench that can support the weight of the instrument is used The bench top should not exceed 90 cm in height so as to ensure an ergonomically correct position for the operator during the input of the commands on the PC Tablet and the loading and unloading of the sample holder racks in the preparer module e VES MATIC 40cm 40cm nircer fig 2 2 1 frontal view with the extensions for rack input The bench top where the instrument will be placed should allow enough space about 40 cm on each side of the instrument for the operator to easily load and unload the sample holder rack in the sample module fig 2 2 1 fig 2 2 2 and fig 2 2 3 Furthermore to be able to reach the connectors on the rear of the instrument and most of all to be able to access the on off switch and the power cable quickly in the case of emergency it is necessary to maintain a safe distance from the wall of at least 20 cm from the rear of the instrument It is totally prohibited to place any material on the instrument for the same reason Rev 2 02 10
99. unctioning 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 analogue sensors optic electronic groups 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 2 The analytical results are obtained from the internal processing of the readings the values obtained are correlated with the Westergren citrate reference method The instrument is designed to express the results of the ESR measurement in Westergren citrate units nevertheless depending on laboratory requirements during installation it is possible to select the expression mode of the results in Westergren EDTA units To select this mode please contact a specialised technician authorised by DIESSE Diagnostica Senese S p A Normal ESR values Westergren citrate Normally ESR values are between 1 and 10 mm hr for men and between 1 and 15 mm hr for women in pathological conditions results can increase to values of up to 100 mm hr and higher Indicative normal range of the Ves Matic Cube 80 instrument values expressed in Westergren citrate units MEN up to 10 mm hr WOMEN up to 15 mm hr These values must be conside

OPERATING MANUAL - DIESSE Diagnostica Senese

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