INSTRUCTIONS MANUAL
Software Release N°3.0
Rev.2.0 issued on February 2016
Automatic instrument for the determination
of the Erythrocyte Sedimentation Rate (ESR)
(Patented)
For In vitro Diagnostic Use Only
Page 1: ...INSTRUCTIONS MANUAL Software Release N 3 0 Rev 2 0 issued on February 2016 Automatic instrument for the determination of the Erythrocyte Sedimentation Rate ESR Patented For In vitro Diagnostic Use Only ...
Page 2: ...STERED AND ADMINISTRATIVE OFFICE Via A Solari 19 20144 MILANO Italy Tel 39 02 4859121 Fax 39 02 48008530 For Technical Assistance please contact your distributor The information contained in this manual may be subject to modifications without notice No page in this manual may be reproduced in any form or by any means neither electronic nor mechanical for any use whatsoever without prior written pe...
Page 3: ...nces in Electrical and Electronic Equipment Directive RoHS2 LIST OF MANUAL REVISIONS APPLICATION OF THE MANUAL This manual applies to the following models of the VES MATIC CUBE 30 DIESSE Code Model description 10390 VES MATIC CUBE 30 MANUAL REVISIONS VERSION SW VES MATIC CUBE 30 DESCRIPTION OF MODIFICATION 0 00 of 10 09 2 06 of 10 09 Initial revision 1 00 of 03 10 2 06 of 10 09 Restyling of the do...
Page 4: ...ing to L D 25 07 2005 no 151 Italy enforcement of the 2002 96 EC and 2003 108 EC directives Warning read the Manual and pay attention to the safety symbols Warning risk of electric shock Legend of symbols used in this document ATTENTION potential hazard of personal injuries all conditions indicated in the text have to be read and understood before proceeding CAUTION potential danger of damage to t...
Page 5: ...ty for more effective technical interventions and assistance after installation The safety requirements and instrument performance are no longer guaranteed if to power the machine a model of cable other than the supplied one compatible with the voltage of the country of installation is used BIOHAZARD Potentially infected material is handled When an analysis system like the VES MATIC CUBE 30 is use...
Page 6: ... 6 RESTRICTIONS AND WARNINGS 19 2 7 SHUTTING DOWN AND SHIPPING 20 CHAPTER 3 21 3 1 TURNING ON THE INSTRUMENT 21 3 2 KEYBOARD 21 3 3 MAIN MENU 22 3 4 QUERY TO HOST 23 3 5 DISPLAYING AND PRINTING OF THE STORED ANALYSES 23 3 6 INSTRUMENT SETUP 25 RECHARGE CD 28 CHAPTER 4 30 4 1 DESCRIPTION OF THE ANALYSIS CYCLE 30 4 2 PREPARATION OF THE SAMPLE 32 4 3 TEST TUBE TYPES 34 CHAPTER 5 35 5 1 GENERAL RECOMM...
Page 7: ...0X50 39 7 5 REPLY MESSAGE WITH COMMAND DATA 41 7 6 RESULT SENDING MESSAGE COMMAND 0X51 42 7 7 QC QUALITY CONTROL SAMPLE DATA SENDING MESSAGE COMMAND 0X52 44 7 8 EXAMPLE OF SERIAL PROTOCOL 47 BIBLIOGRAPHY 48 ATTACHMENT A EC COMPLIANCE CERTIFICATE 49 ATTACHMENT B ACCESSORIES SPARE PARTS AND CONSUMABLES 49 ...
Page 8: ... autologous plasma over a fixed period of time In normal conditions red cells tend to repel each other by virtue of the negative membrane net charge due to the presence of numerous sialic acid residues at the level of membrane glycoproteins When the protein composition of the plasma is changed with the production of so called acute phase proteins as a result of an inflammatory process or tissue da...
Page 9: ... face of the meniscus of the plasma and the upper face of the layer of sedimented red blood cells General functions of the instrument The blood obtained in the test tube for the CBC cell blood count exam is accurately mixed by the instrument the samples then remain at rest for a predetermined amount of time to allow the sedimentation to occur Through analogue sensors optic electronic groups the in...
Page 10: ...5 6 7 Fig 1 2 1 Front view LEGEND 1 Keypad 2 Display 3 3 Paper drawer with printer slot 4 Instrument lid 5 5 30 postion test tube holding plate 6 Numbered test tube positions 7 Check device housing 8 Barcode reader 9 Housings for fitting the plate reducer required for rubber capped test tubes 8 9 ...
Page 11: ...tional Standard power cable IEC 320 C 13 female plug EEC 7 VII Schuko male plug rating 10A 250VAC Packing list and installation report Purchasable consumables for use with the instrument Check Device Transponder RF 1K for VES MATIC CUBE 1000 tests Ref 10292 Check Device Transponder RF 5K for VES MATIC CUBE 5000 tests Ref 10291 Check Device Transponder RF 10K for VES MATIC CUBE 10000 tests Ref 1029...
Page 12: ...r line speed 20 mm sec DISPLAY Liquid crystal graphic 240x128 pixels POWER SUPPLY 110 to 230 VAC 50 60 Hz FUSES 2 x 1 0A Fast 5 x 20 mm ELECTRICAL POWER ABSORBED 65 W max DIMENSIONS 510 x 350 x 500 mm L x H x D WEIGHT 20 kg OPERATING TEMPERATURE 15 C to 35 C STORAGE TEMPERATURE 5 C to 45 C RELATIVE HUMIDITY 20 to 80 without condensation PLATE ROTATION SPEED 1 turn every 1 5 seconds during normal o...
Page 13: ...ock diagram LEGEND 1 CPU board 10 Printer interface 2 Motor driver board 11 Printer 3 Power supply 12 Lid unit solenoid 4 Motor block 13 Lid micro switch 5 Reading sensor unit 14 Forced ventilation fan 6 Check device unit 15 ON OFF switch with mains filter 7 Display keypad interface 16 External connections 8 Graphic display 17 Barcode reader 9 Keypad ...
Page 14: ...pad has 5 keys which are used to activate the VES MATIC CUBE 30 functions TEST TUBE HOLDING PLATE The plate has a radial crown with 30 numbered positions into which the test tubes are inserted These are symmetrically tilted with respect to the rotation axis in such a way as to arrange the test tubes on the cone generator The test tube holding plate is also equipped with a reducer required for use ...
Page 15: ...SINS and SILICON 6 PLASTICS 46 The VES MATIC CUBE 30 instrument is operated by mains voltage therefore has been classified as Electrical Electronic Equipment according to the European Directive 2012 19 UE dated July 04 2012 and subsequent amendments At the end of its life cycle the instrument must be treated as separate collection potentially infected waste and eliminated according to law ...
Page 16: ...1 Complete packaging Package dimensions WIDTH box cm 65 HEIGHT box cm 50 DEPTH box cm 70 GROSS WEIGHT kg 26 PACKAGING WEIGHT kg 6 Do not throw away the original packaging of the internal parts of the instrument in case of further transportation of the instrument in the future 2 2 PREPARATION AND CHECKS PRIOR TO INSTALLATION In order to ensure the safety of the instrument and the operator the follo...
Page 17: ...nnection and the external instruments The operator must be trained to be familiar with the procedures restrictions and warnings indicated in this manual as well as those pertaining to safety in the work place The material for the operator s safety gloves containers for disposing of used expendable items detergent solutions for cleaning the instrument must always be available The positioning of the...
Page 18: ...commended placing the instrument as far away as possible from any electromagnetic waves generators e g refrigerators laboratory centrifuges and instrumentation lacking in the CE mark as these could compromise its correct functioning In order to avoid overheating of the instrument blocking of the fan and to be able to act quickly on the switch and power supply cable the safety distances described i...
Page 19: ...er point Fig 2 5 1 2 6 RESTRICTIONS AND WARNINGS IN CASE OF FIRE OR HAZARDS IN GENERAL TURN OFF THE INSTRUMENT AND DISCONNECT THE POWER SUPPLY CABLE DISCONNECT the instrument from the power supply system before performing any type of technical operation or in the case of malfunctioning of the instrument It is only possible to enter the commands with a light pressure of the fingers It is prohibited...
Page 20: ...s or spillages with a liquid detergent and left to dry B Use one of the ready to use spray cans of isopropyl alcohol available on the market C Spray well inside the instrument and on top of the sample holder plate D Close the lid of the instrument and leave turned off for at least one hour before beginning a new work cycle or any other type of operation on the instrument During handling avoid all ...
Page 21: ...fication number entry procedure with barcode reader To open the lid during the cycle it have to be interrupted by means of a specific procedure ESC key During the initial test the following message is shown on the display Fig 3 1 1 3 2 KEYBOARD Fig 3 1 2 The VES MATIC CUBE 30 is fitted with a Control Panel Fig 3 1 2 that allows easy access to all the programmes controlled by the software of the in...
Page 22: ...cal order analysis cycle if present in case of a new or just updated instrument hence without any saved results the message No analyses in memory will be displayed and the program will return to the main menu after about 2 seconds to scroll up or down in the main menu 3 OK to confirm the item selected in the main menu 3 2 Description Fig 3 3 2 Number of analyses performable without reloading the c...
Page 23: ...erted up to that moment 3 4 QUERY TO HOST VES MATIC CUBE 30 performs the ESR analysis directly on the test tubes used by the blood cell counter in the laboratory Activating the host query you can also select the samples to be subjected to the ESR analysis at the time of loading In fact when the instrument reads the code of a sample it queries the host and once it has received a reply a message on ...
Page 24: ...ect the results to be analysed and press OK to access the next menu Fig 3 5 2 At this point you can decide whether you want to view the analysis results on the display A or print them A Example of result display Fig 3 5 3 To go back to the previous menu press the ESC key ...
Page 25: ... where you can set the time and date Use the arrow keys to change the selected item Press OK to confirm entered value the message Stored will appear on the display and go to the next item set sequence hours minutes day month year At the end of the sequence the program automatically returns to the Setup menu Fig 3 6 2 LANGUAGE Selecting Language from the Setup menu the following page will appear Us...
Page 26: ...ows disabling the printer if you only want to view the results on the display or send them to a host because of a temporary lack of paper in the printer or its malfunctioning The Reverse Printing parameter allows setting the printing direction of the final analysis report Fig 3 6 5 OPERATING MODE Changing the operating mode changes the way the instrument is loaded If the operating mode is set to O...
Page 27: ...provided in the ESR Control Cube the instrument will automatically also fill in the other fields batch expiry date and range If you use different labels you can change the other values using the arrow keys to move from one item to the next and pressing EDIT to change the set value by scrolling up or down with the arrow keys Pressing the NEXT key the values entered will be saved and the instrument ...
Page 28: ...llowing will be printed together with the results of the other samples OK means that TEST was successful or ERR in this case it is advisable to repeat the TEST Should an error occur several times contact Technical Service RECHARGE CD The check device is an electronic device that allows loading a defined number of executable tests to the instrument For each result produced the check device automati...
Page 29: ... Check Device Transponder RF into the dedicated port as shown in the figure 3 6 9 4 Press OK 5 At this point the instrument will show a message that reloading is complete and the test counter will increase Fig 3 6 9 It is advisable to recharge the check device counter when its functionality is not fully exhausted i e when at least sixty executable tests remain ...
Page 30: ...nt in this case it would be easier to set the operating mode to OFF To enter the code you can use the Barcode reader inside of the lid or enter it manually using the keypad by pressing the EDIT key Once you have entered the code a message on the screen will ask you to insert the sample if connected to a host Fig 4 1 1 Before inserting the sample in the first free position it is advisable to agitat...
Page 31: ... the instrument to obtain the ESR values which are then provided to the user according to the settings The instrument at the end of the cycle automatically prints the results as shown in figure 4 1 3 Fig 4 1 3 Filling of the test tube For a correct execution of the ESR exam by the VES MATIC CUBE 30 instrument the level of blood in the test tube is fundamental The instrument itself will verify the ...
Page 32: ...ube is hermetically closed The compatible test tubes are shown in Fig 4 2 1 In case of test tubes not contemplated in these examples you can request a compatibility check by a specialized technician authorized by DIESSE Diagnostica Senese S p A VACUETTE GREINER BIO ONE AND SIMILAR VACUTAINER BD VACUTEST KIMA VENOSAFE TERUMO VACUTRUST ETC RUBBER RUBBER CAP BD TERUMO Consult paragraph 4 3 SARSTEDT F...
Page 33: ... the samples in such a way that the sample layers are opposite the emitter Fig 4 2 3 It is important to verify before loading the instrument that the labels adhere perfectly to the tubes the adhesive parts if unattached could cause frictions during the mechanical movements of the groups ...
Page 34: ...en designed specifically for laboratories that need to process different types of test tubes among which rubber capped so that it can be very easily fitted removed several times a day Step 1 Place the reducer on the plate in such a way that the 3 locking pins slip into the dedicated housings Figure 4 3 2 and that the groove in the pin head is horizontal with respect to the plate numbering Step 2 P...
Page 35: ...ons Use a bland non aggressive detergent solution Do not use solvents diluents acids acetone or similar materials in order to avoid damage of the outer casing SANITISING Procedure for the internal parts accessible to the operator 1 The instrument must be turned off and cleaned of any residues or leakage with a liquid detergent and then left to dry 2 Use one of the ready to use spray cans of isopro...
Page 36: ...loading 9 Push down the print head lever 10 The paper will move further forward until it comes out at the front should it not come out press the button S2 top left on the control board 11 Pull out the paper so that it is cut 12 Tear off the paper protruding from the front 13 Close the flap 5 4 SUBSTITUTION OF THE FUSES Operate as follows to replace the fuses 1 Turn off the instrument and disconnec...
Page 37: ...e 5 5 CHECKING THE SAFETY DEVICES MICRO SWITCHES AND ACOUSTIC DEVICES Follow the procedure below to check functionality of the safety devices 1 Open the lid with the instrument off 2 Turn on the instrument If it is functioning properly an acoustic signal should sound 3 Close the lid and check that it is locked and do a reset If the instrument is functioning properly an acoustic signal should sound...
Page 38: ...RROR This occurs if one full translation of the test tube holding plate is not completed within the established time limit As well as possible electrical faults there may be mechanical obstructions that need to be removed In the first case contact Technical Service CHECK DEVICE EXHAUSTED This occurs when the check device is exhausted Insert a new check device If the error persists contact Technica...
Page 39: ...NTATION 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 0x7A is represented by two ASCII characters 7 0x37 and A 0x41 the first representing the most significant nibble and the second the least significant Examples Original byte HEX ASCII representation Hexadecimal value H character L charac...
Page 40: ...CUBE sends the following frame STX 0x3E H BLK 0x30 L BLK 0x30 H LEN L LEN H ADD 0x30 L ADD 0x31 H COM 0x35 L COM 0x30 Data 1 Data n ETX 0x0D H CHK L CHK The hexadecimal values indicated in brackets are constant values for this message The fields in bold type are variable and described below H LEN L LEN Length of the data field from Data 1 through Data n represented in HEX ASCII Maximum Value F 0x4...
Page 41: ...ect length of the data field etc ACK message ACK 0x06 H ADD 0x30 L ADD 0x31 ETX 0x0D ACK message timeout 2 sec NACK message where H ERR L ERR are the HEX ASCII representation of the error code defined according to the following table Error code H ERR value L ERR value Meaning 0x00 0x30 0x30 Generic error 0x04 0x30 0x34 Checksum error 0x05 0x30 0x35 Field value error H LEN L LEN 0x06 0x30 0x36 Data...
Page 42: ...tabase If the barcode string terminates with the byte 0x11 it means that the sample code is unknown in this case VES MATIC CUBE will process the sample but the result will not be printed at the end of the test but stored in the pending database Data message timeout 5 sec 7 5 1 Data reply message error If VES MATIC CUBE detects an error in receipt of this message it will repeat the transaction from...
Page 43: ...K ID ASCII string of 4 characters POSITION ASCII string of 2 characters BARCODE ASCII string of variable length maximum 15 characters permissible This is the barcode as read by the VES MATIC CUBE barcode reader Terminator The barcode string terminates with the byte 0x10 This is because the length of this string is variable ANALYSIS DATE String of 6 characters without DDMMYY terminator where DD day...
Page 44: ...by the host as an Uncertain Result in the report the result is printed and marked with an asterisk H CHK L CHK CheckSum of the message represented in HEX ASCII The Checksum is calculated executing the exclusive OR of all the bytes sent from STX through ETX The resulting hexadecimal value is then converted into HEX ASCII and the two characters that represent it are sent For debugging purposes you c...
Page 45: ...ASCII string of 6 characters Identifies the production batch of the control blood EXPIRY DATE String of 6 characters without DDMMYY terminator where DD day of the month from 01 to 31 ASCII MM Month of the year from 01 to 12 ASCII YY Year of the century from 00 to 99 ASCII H VALMIN L VALMIN The minimum value of the acceptability range for the control blood represented in HEX ASCII H VALMAX L VALMAX...
Page 46: ... high 1 Sample Low Blood column too low 2 Sample Absent Test tube empty 3 Abnormal Error in height acquisition 4 QC PASS The QC ESR measured is within the acceptability range 5 QC FAIL The QC ESR measured is outside the acceptability range 6 7 Reserved EXAMPLES In case of a Sample High error bit 0 least significant will be set to one and all the others to zero therefore the byte of the flags will ...
Page 47: ...quest for sample code to process 50 H L NUM number of barcodes included in this message 02 hex 2 barcodes SAMPLE 1 BARCODE TERMINATOR SAMPLE 2 BARCODE TERMINATOR ETX character 0x0D H L CHK xor of all the characters from STX through ETX 2 Example of request for authorisation sent to the host for two barcodes of two samples and reply for analysis authorisation only for the second see paragraph 7 4 3...
Page 48: ...onocyte volume and mean neutrophil volume are associated with markers of folic acid deficiency 2011 Clin Chem Lab Med 49 Special Suppl pp S1 S874 2 Pini F Paoli L Barlettani B Campigli R Faggiani L Comparison of two systems for the determination of the erythrocyte sedimentation rate in blood EDTA samples 2010 DIESSE Diagnostica Senese S p A Marketing information 3 Westergren A The Technique of the...
Page 49: ...VT PLUG USA OUTLET VDE 2MT UL Power cable Ref R21890370 1 Z 3080 Cable CAB50607 R9 Barcode reader Ref R20550510 Consumables Check device Transponder RF 1K for VES MATIC CUBE 1000 tests Ref 10292 Check device Transponder RF 5K for VES MATIC CUBE 5000 tests Ref 10291 Check device Transponder RF 10K for VES MATIC CUBE 10000 tests Ref 10290 ESR Control Cube 4x9ml 2 normal vials 2 abnormal vials Ref 10...
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