Mixrate-X20 - United Laboratories Company
Contents
1. YES YES NO NO 7 3 Sample insertion batch mixing mode To initialize integrated sample mixing simply close the plastic cover after samples have been inserted into the analyzer Once the cover is closed samples are automatically mixed for five minutes Time remaining is shown on the screen during the mixing When the mixing feature is used samples are run in a batch mode 7 4 Sample insertion in random mode For sample identification follow the instructions in Section 3 1 After pre mixing the sample must be promptly transferred to the analyzer It is recommended to follow a numerical sequence while loading the channels The operator can check the display for the proper location in which to put the new test tube if ID function 2 is used For the random mode insertion DO NOT CLOSE THE COVER If the cover is closed automatic mixing will start and analysis in process will be re started from the beginning Channel positions on the support plate are numbered from 1 to 20 Numbering is meant progressively in groups of 20 samples so when the analysis of the sample in channel number 1 is complete the new pa sample inserted in channel 1 automatically becomes sample number 21 and so on with the other samples After insertion of the twentieth sample wait for the CORRECT MIXING results of the first loaded sample Once compl2. 20 3 34 MIX Rate X20 USER S MANUAL Vital Diagnostics 8 6 RESIDUALIRISKS A AO APA OE EE 20 9 PERFORMANCE CRITERIA AND 21 9 1 PERFORMANCE GRITERIA EL A A S LE LLL Le 21 9 2 IMETATIONS A A A 21 10 TEMPERATURE 21 10 1 RESULTS CORRECTION 48 Gives tete lilla alice riali iaia 21 11 iii 22 11 1 MAINTENANCE pit DU de e ie a a ia e le i e ne ne le n e ia e le 22 11 2 GEEANINGINSTRUGTIONS pi E ERA 22 12 ul gna VC 22 12 1 RESULT DATAERRORt4 E E I I E O DS 22 12 2 OE ERROR E EER T E E E 22 12 3 CHECK PRINTER 22 12 44 EGHECKHOST CONNECTION s E ER E A 22 12 5 ERROR SYSTEM STOPPED KE E A AI R 22 13 TROUBLESHOOTING 23 14 APPENDIX Nee 23 14 1 WESTERGRENIMETEQGOPD ar he oh ot A R EER E E deo Pai EEE 23 14 2 REFERENCE RANGES OF NORMAL ESR VALUES
3. Pag 8 34 Vital Diagnostics MIX Rate X20 USER S MANUAL After the operating time has changed a message will appear indicating that the results stored in memory will be deleted see Figure 3 Press ENT to accept and ESC to abort Res config changedt deleting results deleting data CENT to accept t ESCI to abortt Figure 3 T REF The Mixrate X20 features an automatic adjustment of temperature related to the reference temperature of 18 C in accordance with Manley see Section 8 Temperature Compensation for further details To change this setting select No PRINT The default printer is an internal printer as indicated by the INT If you wish to connect an external printer select EXT Select NO if a printer will not be connected and you do not wish to use the internal printer GRAPH To view the sedimentation graph see Section 4 4 set Graph to either Yes or Auto If Auto is set the sedimentation graph will print with each result HOST The instrument may be connected to a Laboratory Information System LIS To transfer the results to a laboratory computer it is necessary to select YES or AUTO on the HOST line DATE and TIME If needed register the date and local time by moving the cursor to the desired line and pressing enter Use the numeric keypad to enter the numbers The date format is month day year Additionally a 24 hour clock is used e g 2 00 p m would appear as 14 00
4. The Mixrate X20 was designed and manufactured to conform to various national and international standards and safety regulations Possible known risks were eliminated or reduced Nevertheless all risk cannot be eliminated When operating the Mixrate X20 national guidelines and regulations must be observed as in the normal lab routine Power supply accessories cables plugs must be installed in such a way that sources of danger overheating of cables short circuit due to incorrect fuse ratings loose cables etc are eliminated The user should be aware that if the Mixrate X20 is not used in the manner specified by the manufacturer the protection provided by the equipment and the measurement results may be impaired This manual should be kept with the instrument for consultation when necessary CAUTION To assure proper instrument performance Vital Diagnostics requires the use of Vital Diagnostics ESR Vacuum Tubes or ESR Non Vacuum Tubes and Precision Rate Controls with this analytical system This instrument is designed as a system Results obtained from the system may vary depending upon the specific characteristics of disposables controls and operator expertise Control kits and the test parameters for each control have been optimized and tested to ensure compatibility and performance with the instrument Vital Diagnostics assumes no responsibility for erroneous test results caused by disposable tubes or controls not supplied by Vital Diagno
5. THYGESEN J E 1942 The mechanism of blood sedimentation Acta Medica Scandinavia Suppl 134 WINTROBE M M and Landsberg J W 1935 A standardized technique for the blood sedimentation test American Journal of Medical Sciences 189 102 HARDWICKE J and SQUIRE J R 1965 The basis of the erythrocyte sedimentation rate Clinical Science 11 333 International Committee for Standardization in Hematology 1977 Recommendation for measurement of erythrocyte sedimentation rate of human blood American Journal of Clinical Pathology 68 505 LASCARI A D 1972 The erythrocyte sedimentation rate Pediatric Clinics of North America 19 1113 MANLEY R W 1957 The effect of room temperature on erythrocyte sedimentation rate and its corrections Journal of Clinical Pathology 10 354 CDC Universal Precautions U S Department of Health and Human Services Recommendation for Prevention of HIV Transmission in Health Care Settings MMW Report Aug 21 1987 Vol 36 No 2S Pag 24 34 Vital Diagnostics MIX Rate X20 USER S MANUAL 14 4 Hardware specifications 14 4 1 Power Supply Units Specification Manufacturer Dee Van Enterprises DVE Model DSA 0421S 12 Input 100 240 Vac 47 63 Hz Output 12Vdc 3 5A Warning For user s security and instrument safety use only original power supply unit NOTE In case of power supply cord substitution use only power supply cord listed certified minimum 18 AVG 3C VW 1 Min
6. M c RES zh RESULT Res XX The default factory setting of the Mixrate X20 is Result 1h with PRINT lin Hi ET a 30 minute working time This setting provides results which are displayed and HUST E HUT printed in 30 minutes for each measurement referenced to one hour Westergren TIME 69 56 The coefficient of correlation at a 30 minute working time with the Westergren method is R 0 98 To change the default set the desired setting to Yes More than one result may be pa chosen For example by selecting 30 1h and 30 60 the operating time opt Lene remains at 30 minutes and the results are reported for both 30 minutes and for 1 dei hour referencing the Westergren method By selecting 2h the operating time is and time one hour for each measurement referencing the 2 hour Westergren All three excu combinations are possible with a 2 hour operating time and all three results reported Figure 2 If the 15 minute working time is selected W Time 15 results are displayed and printed in 15 minutes referenced to one hour Westergren Results can only be correlated to a one hour value results cannot be correlated to 30 minutes or 2 hours in the 15 minute working time mode The coefficient of correlation at 15 minutes working time with the Westergren method is less than R 0 92 NOTE Changing the operating time with results stored in memory requires a reset of the memory and stored results will be deleted
7. eene nenne nennen nennt enn 23 14 3 ESFRIN DISEASE STATES SN de tonni de tei PI ona PE LC D e I Dee I o Ele na OLI 24 144 HARDWARE SPECIFICATIONS A a E ee eee ev eva Re eU 25 14 4 1 Power Supply Units 5 25 14 4 2 Power Connector DescripliOT iri citri titii ARRA A ARA LERRA RR RR RA ARRA 25 14 4 3 Printer Connector Description 25 14 5 HOST SBPEGIEIGATIONS ceo Dee hee e dE I SG die e 25 14 5 1 Host Connector Description 25 14 5 2 Barcode Connector Description 25 14 5 3 Host Connection Specifications Communications 26 14 5 4 HOST CONNECTOR SIGNALS DESCRIPTION ie 26 14 5 5 HOST DATA TRANSMISSION REQUEST FROM HOST 26 14 5 6 MESSAGES SENT IN THE GEOGINNINMG ie 26 14 5 7 MESSAGE SENT FOR ANY RESULT STORED IN 27 14 5 8 DESCRIPTION OF THE DATA ERAME 27 14 6 INTERFACING SPECIFICATIONS i 28 14 6 1 Basic PIOCOEUUfFe ee ee ee 28 14 6 2 COGEO E 28 14 6 3 Hardware CONfigUrationi 28 14 6 4 Software COnNtIGUTAtION E 28 14 7 FORMAT 8 EXAMPLE DATA FILE ve 30 5 4 GHECKSUM GALGULATIONJ eU EE KISA ENI KISI te 30 15
8. Mixrate X20 USER S MANUAL Manual Ge MAN 053 Revision 04 Bev n date 05 23 2008 MIX Rate X20 USER S MANUAL Vital Diagnostics Pag 2 34 Vital Diagnostics MIX Rate X20 USER S MANUAL CONTENTS T INTRODUCTIO N ul La 6 1 1 OPERATOR OVUALIFICATION sena 6 1 2 ANALYTICAL RESULTS stia 6 PAM ui pd lm 7 Bis IMPROPER USE 2 eerie iie 7 4 INSTALLATION oje iii 7 4 1 PLACEMENT OF THE ANALYZER ii 7 4 2 elle age E 7 4 3 POWER ON S 7 4 4 SETUP MAIN MENU FUNCTION 6 8 5 FUNCT ONS 9 5 1 MAIN MENU FUNCTION 1 ID SAMPLES IDENTIFICATION eeeeeeeennnn eene nnne 9 5 1 1 Samples Identification Sub Menu Function 1 101 10 5 1 2 Samples Identification Sub Menu Function 2 ID 11 5 2 MEMORY MAIN MENU FUNCTION 2 11 5 2 1 Memory Sub Menu Function 1 11 5 2 2 Memory Sub Menu Function 2 En 12 5 3 QUALITY CONTROL MAIN MENU FUNCTION 3 OC 12 5 39 1 QC INR Sub Menu Function 2 sis 0 p On i 13 5 3 2 2 5 1 tet et t e e 13 5 8 8 QC CH Sub Menu Function 4 14 534 QC Sub Menu F nclion 8 ooi v v ra iieii 14 535 Sub Menu Function 8 E 15 53 6 Sub Menu Funet
9. If the printer was enabled in the setup function then the printer must be ESCI to abort connected and ready to print Check the printer connection or turn off the printer in the setup function 12 4 CheckHost Connection If the host option is enabled in the setup function then the host system must be connected and ready to receive data If this error message is received check the host connection or turn on hosting in the setup function Figure 24 12 5 Error System Stopped This message will be displayed if the instrument is ERROR system stopped not functioning and has completely stopped due to mechanical problems with the reading plate movements Contact Technical Support Figure 25 Pag 22 34 Vital Diagnostics MIX Rate X20 USER S MANUAL 13 TROUBLESHOOTING Before calling for a service technician please check the handling of sample collection mixing procedures and operating instructions ERROR ALARM CAUSE REMEDY lev a Sample level high or low a Repeat sample collection b The label was not placed in its b Replace label and repeat proper position analysis Sample has been removed Re insert sample Temp T ERR Temperature sensor malfunction Call Technical Support System stopped Motor or mechanical defect Call Technical Support Data result is not printed a Printer setup turned off Check setup and turn b Printer cable b Check cable i Printer malfunction 5 Replace printer Data resu
10. The Day is changed Each time the Mixrate X20 is switched on it carries out an electronic initialization and an instrument self test to check for proper operation deleting results CENT to accept ESCI to abortt Pag 7 34 MIX Rate X20 USER S MANUAL Vital Diagnostics After initialization the main menu will be displayed see Figure 1 The numbers from 1 to 20 on the screen indicate the positions channels for MEMORY samples to be placed while indications relative to the status of the analysis appear above channels 1 through 10 and below channels 11 through 20 See Section 4 3 PRINT for complete symbol descriptions HOST SETUP On the top of the display there are six 6 functions They can be accessed by pressing the appropriate number on the keypad Main Menu Functions ID Register the identification number for each sample MEMORY Display and edit data stored in memory QC Quality Control program PRINT Print a work list or print the results of the analysis HOST Transfer data to the host computer Fi 1 SETUP Initial setup and configuration of the instrument igure See Section 3 Functions for further details 44 Setup Main Menu Function 6 The operating parameters of the Mixrate X20 are factory set to the default values ofruara 1 8 shown in Figure 2 The parameters may be changed by using the UP and DOWN li TIME Bl 15 arrows to move the cursor through the menu options
11. 75 C minimum SVT type 14 4 2 Power Connector Description PIN DIRECTION NAME DESCRIPTION 1 internal 12V Power supply 12Vdc 3 5A 2 external GND Ground 14 4 3 Printer Connector Description Instrument 9 pin female connector PIN DIRECTION DESCRIPTION 1 Do not connect 2 Do not connect 3 OUTPUT TXD Serial data output 4 OUTPUT DTR Data Terminal Ready 5 Ground 6 Do not connect 7 Do not connect 8 INPUT CTS Clear to send 9 Do not connect 14 5 Host specifications 14 5 1 Host Connector Description Instrument 9 pin male connector PIN DIRECTION NAME DESCRIPTION 1 Do not connect 2 INPUT RXD Serial data input 3 OUTPUT TXD Serial data output 4 OUTPUT DTR Data Terminal Ready 5 GND Ground 6 Do not connect 7 Do not connect 8 INPUT CTS Clear to send 9 Do not connect 14 5 2 Barcode Connector Description Instrument 9 pin male connector PIN DIRECTION NAME DESCRIPTION Pag 25 34 MIX Rate X20 USER S MANUAL Vital Diagnostics Do not connect INPUT RXD Serial data input Do not connect OUTPUT DTR Data Terminal Ready GND Ground Do not connect Do not connect Do not connect Do not connect 2 MH wa 14 5 3 Host Connection Specifications Communications Protocol EXAMPLE OF A CONNECTION TO A PC IBM COMPATIBLE COMPUTER No
12. After any adjustments are made press the ESC button return to the main menu 5 FUNCTIONS 5 1 Main Menu Function 1 ID Samples Identification After selecting 1 ID the instrument shows two options 101 and 102 to record the data see Figure 4 Pag 9 34 MIX Rate X20 USER S MANUAL Vital Diagnostics 5 1 1 Samples Identification Sub Menu Function 1 ID1 After selecting 1 ID1 enter a patient s code by either entering the number the keyboard and pressing enter or scanning the barcode by passing the tube in front of the CCD scanner window located on the right side of the analyzer The tube should be swiped at a distance of approximately 6 If the barcode does not scan move the tube side to side left to right in the path of the LED until you hear a beep and the ID code is accepted If desired an external barcode reader can be connected to the BARCODE port NOTE f the keyboard is used to enter the barcode ID enter must be pressed after the ID code is input lf enter is not pressed then the insert instrument will not recognize the ID 123131 esc to exit NOTE The CCD scanner is made up of red LED s and emits visible Figure 5 red light that is not dangerous for the operator Duaci ieee Cano DODO donno bobo After the barcode is accepted the operator will be instructed to insert the tube into any open position see Figure 5 The analyzer will detect the channe
13. INTERNAL BARCODE SCANNER DEFAULT CONFIGURATION 31 16 TECHNICAL 32 17 EC DECLARATION d ES 33 18 DISPOSAL AND RECYCLING 34 Pag 4 34 Vital Diagnostics MIX Rate X20 USER S MANUAL Pag 5 34 MIX Rate 20 USER S MANUAL Vital Diagnostics 1 INTRODUCTION Prior to operating the Mixrate X20 carefully read the instructions in this manual for proper use of the instrument Mixrate X20 has been designed to simplify ESR analysis avoiding sample handling and reducing the operators risk of infection To perform the analysis the operator simply places the sample in the instrument The results are complete in 30 minutes correlated to one 1 hour following the Westergren reference method This feature allows the instrument to be used directly on the ward in the blood sample collection department and in small laboratories Caution Before installing and working with the Mixrate X20 analyzer read this manual carefully and observe the safety precautions and regulations stated Safety comes first
14. hex data in the data frame between ETX and STX including ETX but not STX This is equal to 0519 hex The least significant byte from 0519 is 19 the ASCII equivalent of these digits is 31 39 the check sum data 5 5 Host participation IMPORTANT There is no host intervention in communication protocol If the host finds checksum does not match the data the only thing the host can do is to request the Mixrate X20 resend data by sending a character Pag 30 34 Vital Diagnostics 15 INTERNAL BARCODE SCANNER DEFAULT CONFIGURATION The instrument is supplied with a default barcode configuration that enables the reading of the most commonly used barcode label formats The barcode scanner manual supplied with the instrument can be used to enable or change configuration for other formats Use the barcode scanner to change settings Caution Wrong configuration codes may lead to barcode scanner malfunction In case of reading problems this page can be used to reset the scanner to the factory setting Turn on the instrument wait for the self test to complete and then read all barcode labels on this page from top to bottom The configuration is automatically saved in the barcode scanner MIX Rate X20 USER S MANUAL DEFAULTS uf jz START 98d fs RS232 8500118 FLASH 50276 CR Sez SO ALL SAIL END SAVE
15. in the appropriate support and the erythrocyte level is read after 60 minutes 14 2 Reference Ranges of Normal ESR Values Normal ESR Values male female After 1 hour mm 0 15 0 20 Greer John P et al 2004 Wintrobe Clinical Hematology 11th ed Vol 2 pp 2697 Philadelphia Lippincott Williams amp Wilkins Pag 23 34 MIX Rate X20 USER S MANUAL Vital Diagnostics 14 3 ESRin disease states ESR 100 mm or more per hour Multiple myeloma Waldenstrom macroglobulinemia Internal hemorrhage Etopic pregnancy Acute hepatitis Malignant lymphoma Leukemia Oral contraceptives Serious anemia Carcinomas Menstruation Serious bacterial infections Sarcomas Normal pregnancy after the third month Collagenosis Biliary or portal cirrhosis Tuberculosis Ulcerative colitis Nephrosis Dextran administration Postcommissurotomy syndrome ESR Moderate increase Acute and chronic contagious diseases Acute localized infections Reactivation of a chronic infection Rheumatic illness Rheumatoid arthritis Myocardial infarction Malignant tumor with necrosis Hyperthyroidism Hypothyroidism Lead or arsenic poisoning Nephrosis ESR Normal values First stage acute appendicitis Whooping cough Malarial paroxysm Cirrhosis of the liver Arthritis Mononucleosis Acute allergies Virus infections without complications Peptic ulcer Typhoid fever Rheumatic carditis with cardiac decompensation Bibliography
16. so that results are not affected Once the samples have been inserted return to the main menu to monitor the status of the analysis by pressing ESC During analysis symbols are shown on each channel to indicate time remaining see Section 4 3 5 2 Memory Main Menu Function 2 MEM Up to 500 results can be stored in memory at one time although the manufacturer recommends clearing the memory at least every other day When the instrument is turned on at the start of a new day the user is prompted to delete results see Figure 8 Pressing enter will erase all the pay is changed records in memory ESC aborts this action self test MEMORY QC PRINT HOST deleting results SETUP 4 p CENT to accept When the memory is full a warning message will be ESC to abortt displayed and the analyzer will emit a beep see Figure 9 Press CANC key to clear this message H E El El El Figure 8 WARNING memory full press CCAHCI to clear this message WARNING When the memory is full the instrument will overwrite samples already in memory starting with the first sample stored sample 1 Figure 9 5 2 1 Memory Sub Menu Function 1 Clear Use option 1 to clear the memory This will delete all data stored in memory so caution should be used After 1 is pressed a warning message will appear see Figure 10 To continue press ENT to accept or press ESC to abort deleting results CENT to acce
17. string lt ETX gt ECC MIX Rate X20 USER S MANUAL ECC represent the checksum used to detect if a string transmitted is defective The checksum is encoded as two characters sent after the lt ETX gt character The checksum is computed by adding the binary values of the characters in a string modulo 256 and keeping the least significant 8 bits of the result The 8 bits can be considered as two groups of 4 bits which are converted to ASCII and represented in hexadecimal format The two ASCII characters are transmitted as the checksum with the most significant character first Using the following frame as an example the checksum for this frame is calculated Example lt STX gt ABCDEFGHI lt ETX gt 70 Character ASCII value A 065 1st character for calculation B 066 2nd C 067 etc D 068 etc Pag 27 34 MIX Rate X20 USER S MANUAL Vital Diagnostics E 069 etc F 070 etc G 071 etc H 072 etc 073 etc lt ETX gt 003 etc Total sum value 624 Module 256 624 is 112 Then 112 decimal is 70 hex ECC is 70 If ECC length is 1 character the resultant ECC is adding a zero character ASCII 48 on the left Example First ECC The resultant ECC is 14 6 Interfacing specifications This document contains moderately complex technical information The reader should have an intermediate level of knowledge in the following areas Computer systems Computer communications This manual assumes that the users of Wi
18. 14 mf JO Pag 31 34 MIX Rate X20 USER S MANUAL Vital Diagnostics 16 TECHNICAL SPECIFICATIONS Area of application Operating Conditions Tube employed Reading channels Analysis time Analytical capacity Loading capacity Loading pattern Results Temperature correction Measuring method Reading resolution Results resolution Acceptable blood draw level Display Interface Instrument size Weight Voltage Pag 32 34 Erythrocyte sedimentation rate analysis 15 32 C room temperature Humidity 4596 8596 Special 8 x 120 mm tubes 20 15 30 or 60 minutes Maximum 40 tests hour 30 minute working time Maximum 80 tests hour 15 minute working time Maximum 20 samples at a time Random In Westergren mm h by interpolation Automatic compensation referenced to 18 Manley Infrared beam 0 2 mm 1 mm 0 90 to 1 20 ml GRAPHIC LCD with backlight RS232 for printer host and barcode scanner Height 200 mm Width 330 mm Depth 310 mm about 5 kg External power supply 100 240 Vac 47 63 Hz 12 Vdc 3 5A Vital Diagnostics MIX Rate X20 USER S MANUAL 17 DECLARATION DICHIARAZIONE DI CONFORMIT CE EC DECLARATION OF CONFORMITY conforme all Allegato Ill della Direttiva 98 79 CE Dispositivi Medico Diagnostici In Vitro conforme all Allegato Il della Direttiva 2006 42 CE Direttiva Macchine according to
19. Annex II of the Directive 98 79 CE In Vitro Diagnostic Medical Devices according to Annex II of the Directive 2006 42 CE SSL Vital Diagnostics S r l manufacturer Via Balzella 41 G 4 indirizzo address 47100 FORLI ITALIA telefono fax phone 0039 0543 721220 fax 0039 0543 796001 Identificazione dei prodotti Analizzatore Automatico della VES Product identification ESR Automated Analyzer Nome commerciale Mixrate X20 Brand name Numero i di catalogo PRD X20 EL O8TKN Part number s classificazione dei prodotti dispositivi diversi da quelli elencati nell Allegato Il della Direttiva 98 79 CE product identification devices other then those mentioned in Annex Il of the Directive 98 79 EC Si dichiara sotto la propria responsabilit che i dispositivi sopraelencati rispettano le disposizioni applicabili delle seguenti direttive Hereby we declare under our sole responsibility that the above mentioned devices meet the applicable provisions of the following Directives Direttiva 98 79 CE Direttiva 2006 42 CE Direttiva 2004 108 CE Compatibilit Elettromagnetica Direttiva 2006 95 CE Bassa Tensione Direttiva 2002 96 CE e 2003 108 CE RAEE Direttiva 2002 95 CE RoHs Tutta la documentazione tecnica comprovante il rispetto dei requisiti applicabili delle Direttive elencate conservata a cura del Fabbricante All the technical documents required to demonstrate the conformity to the listed Directives are kept by the Manufa
20. Position with ID no tube 7 Test finished X Pag 16 34 Vital Diagnostics 6 4 Sedimentation graph It is possible to monitor the state of the sedimentation by viewing the sedimentation graph see Figure 23 Select the sample to monitor from the main menu by moving the arrows and then press Enter to view the graphic Pressing enter a second time enables you to print Moving the arrows up and down allows you to pass to the next or previous samples The graph can only be viewed if the Graph Setting is set to Yes or Auto in the Setup menu See Section 2 4 Setup 6 5 ESR Tubes Specially designed vacuum and non vacuum ESR measurement tubes supplied by Vital Diagnostics must be used to ensure accuracy of measurement for the Mixrate X20 Both types of tubes contain sodium citrate at 3 8 Vacuum tubes are made to draw 1 2 mL of blood Refer to package insert for detailed instructions 7 OPERATING PROCEDURE 7 1 Sample collection MIX Rate X20 USER S MANUAL EDIT ID H time minutes 68 mme ZE mm zh z 36 3140 Figure 23 Samples must be collected following the techniques shown in the Vital Diagnostics ESR Vacuum and Non Vacuum package inserts The following external factors can alter the ESR value after blood collection Dilution ratio Bubbles Strongly hemolyzed samples Sudden agitation Temperature Time after sample taking Direct sunlight Foam Lipemic samples Tube
21. city of 20 test tubes at a time When a sample has been analyzed it can be replaced by another so it is possible to analyze up to 40 tests per hour Mixrate X20 has been developed to simplify ESR analysis as much as possible avoiding sample handling and the operator s infection risk To perform the analysis the operator places the sample test tube into the instrument The results are complete in 30 minutes correlated to one 1 hour Westergren This feature allows the instrument to be used directly in the blood sample collection department and in small laboratories In performing the analysis the Mixrate X20 surveys the room temperature and converts the result to the reference temperature of 18 C Manley This is necessary in order to avoid considerable variations of values due to different room temperatures 6 2 Results in 15 minutes Mixrate X20 can be run in a 15 minute working time mode If selected results are displayed after 15 minutes referenced to 1 hour Westergren Results are correlated to a one hour value results cannot be correlated to 30 minutes or 2 hours in the 15 minute working time mode The coefficient of correlation at a 15 minutes working time referenced to the Westergren method is less than R 0 92 6 3 Symbol Description 1 Tube inserted start time 2 Tube inserted complete CI E L Tube inserted L complete 4 Tube inserted end time 1 d 5 Empty position 6
22. cturer anno di immissione in commercio year of introduction on the market luogo e data place and date Forl 11 03 2008 2006 firma 7 Mo signature gt timbro della Societa Pag 33 34 MIX Rate 20 USER S MANUAL Vital Diagnostics 18 DISPOSAL AND RECYCLING Herewith we declare that this instrument is subject to the European Directive 2002 96 EC RAEE Directive Therefore the instrument must be disposed separately not as urban waste and delivered to the specific collection center in according to the Directive 2002 96 EC The user can ask to the dealer the collection of the instrument if a new instrument is ordered to replace the old one On the instrument there is a label with the symbol shown in this page The symbol means that the instrument can not be disposed as urban waste 24 Pag 34 34
23. el as there are no specially assigned positions for the controls When the control results are ready the instrument will print the data and store the results in the QC memory When the control samples are being analyzed the individual channel display will show C see Figure 16 NOTE Vital Diagnostics recommends using control solutions with known values for each test and running two levels each day of use in accordance with CLIA and local regulatory guidelines Results obtained should fall within the limits defined by the day to day variability of the system as determined in the user laboratory If the results fall outside the laboratory s established limits refer to the troubleshooting information in this manual 5 3 3 QC CH Sub Menu Function 4 This function allows the operator to view a Yuden Plot graph detailing the QC results over the last 30 days Press 4 from the QC menu to display the graph see Figure 17 To print see Section 3 3 5 5 3 4 QC ED Sub Menu Function 3 The calculated QC values are shown on the right side of the screen and may be used to replace the theoretical values inserted at beginning of the lot To adjust the theoretical values of the graph press 3 to enter into QC ED The theoretical values are displayed to the left of the screen while the instrument s calculated values are display to the right of the screen To replace the theoretical values with the new values select the QC type either 1
24. ent until it is disconnected from the power supply If the power is on damage can be caused by moving parts Do not try to stop the agitator manually or inserting something between the moving part and the device This could cause instrument s damage The operator can t be injured by the agitator because the moving part is driven by a low power motor and the motor is via software controlled in order to stop its movement every time an external object force blocks its movement 84 Samples Analysis biological fluids must be considered potentially infectious by the operator Even if it is not necessary to remove the cap during the analysis and so there is no direct contact with blood the operator must adopt the national and international standards of precautions to avoid the biological danger Specimens patient samples and controls and liquid waste should be considered potentially infectious and capable of transmitting human immuno deficiency virus HIV hepatitis B virus HBV and other bloodborne pathogens The handling of these substances must be performed in accordance with established laboratory safety regulations CDC Universal Precautions U S Department of Health and Human Services Recommendation for Prevention of HIV Transmission in Health Care Settings MMW Report Aug 21 1987 Vol 36 No 2S in order to minimize risk to laboratory staff This includes wearing of gloves splash protection etc Contact with skin and mucous membrane
25. ete remove the analyzed samples and insert new test tubes in these channels to continue the analysis 7 5 Sample removal During the analysis the display on the Mixrate X20 shows the operative state of the instrument time remaining symbol see Section 4 3 and already concluded analysis Before the final result is shown on the display the operator is advised by two short beeps 7 6 Final Results When the analysis is finished the results are printed The X symbol will remain on the display until the operator removes the corresponding test tube from the analyzer After removing the tube the displayed X will disappear within one minute Removal of the tube causes the displayed result to clear Once cleared the operator may insert a new sample into the channel Pag 18 34 Vital Diagnostics MIX Rate X20 USER S MANUAL Brief Working Instructions Set up instrument Connect the power supply Insert paper in the internal printer Turn the instrument on by pressing the switch located at the rear side of the instrument The display will show free channels to insert samples as indicated by this symbol Sample Insertion choose from one of the following Insert well mixed sample into any free channel Insert unmixed samples into free channels and close the cover to begin the mixing process 01 Scan the barcode and insert well mixed sample into any free channel 01 Scan the barcode and insert samples into free channe
26. g temperature value with one decimal Transmitted only if the temperature correction is enabled Pag 26 34 Vital Diagnostics 14 5 7 MESSAGE SENT FOR ANY RESULT STORED IN MEMORY sss pp mmmm 30mm 60mm where sss is the sequential sample number 1 999 pp sample location identified by a number from 1 to 20 patient ID code if not present mmmm 30 analysis result whose values can be shown as sample under analysis LEV if error level REM if sample error mmm result in millimeters on the right gt 140 result more than 140 millimeters 30mm 1h analysis result whose values can be shown as sample under analysis if the result of mmmm is an error or the value is higher than gt 140 mmm result in millimeters on the right gt 140 result more than 140 millimeters 60mm 2h the result of the analysis can have the following values sample under analysis if the result of mmmm is an error or the value is higher than gt 140 mmm result in millimeters on the right gt 140 result more than 140 millimeters Note the 60mm result is present only if the instrument works in mode 60 lt is send if the instrument works in mode 30 14 5 8 DESCRIPTION OF THE DATA FRAME Any string of characters is transmitted with the following frame lt STX gt
27. inclination recommendations of the Time of test In accordance with the International Committee for Standardization in Hematology ICSH blood samples collected in this manner should be tested within 4 hours if left at room temperature or within 6 hours if stored at 4 C Samples must be brought to room temperature prior to analysis 7 2 Labeling Identify the sample by writing on the original test tube label or by applying a bar code label Follow the scheme to carry out this action correctly In the figure the test tube A has the correct blood level and the original label on which to write the patient code or any other relevant data if the bar code label is absent The part marked H shows the transparent zone that must be absolutely free and clear to allow the infrared rays to recognize the end of the blood column The next test tube B shows the correct position for the label Test tubes C and D illustrate how erroneous applications of the labels obstruct the reading of the analysis If the Mixrate X20 is installed in the surgery the sample can be immediately analyzed by placing samples in a free position Anyway the sample should be analyzed within three hours paying attention to external agents shown below that might alter ESR in the pre analysis phase Pag 17 34 MIX Rate X20 USER S MANUAL Vital Diagnostics
28. ion TEE 15 5 4 PRINTOUT FUNCTION 4 PRINT uf EE dE EE AAP ERP TER 15 SAT Met Sub Menti Function I ee 15 5 42 gt Memory Sub Menu Function OH 15 5 4 3 Memory Range Sub Menu Function 3 15 5 5 HOST FUNCTION 5 HOST 16 6 SYSTEM DESCRIPTION red ecce ege Eege coles ese 16 6 1 MIXRATE X20 ANALYZER eae ob aee a charte Prae cei oil 16 6 2 HESUETSTNH T5 MINUTES Een Een la ICI MIC reca 16 6 3 SYMBOL DESORIPTION sele ta ctae na LASA IA EH MAR REA EE CHEER REC EE 16 6 4 SEDIMENTATION GRAPH 17 6 5 EE 17 T gt OPERATING PROCEDURE ee 17 7 1 SAMPLE eeler 17 7 2 le 17 7 3 SAMPLE INSERTION BATCH MIXING MODE nana 18 7 4 SAMPLE INSERTION IN RANDOM MODE EE EES nEn Ener Ennen Eneee nnne 18 7 5 SAMPLE REMOVAL 18 7 6 FINALRESULTS snai oi 18 7 7 BRIEF WORKING INSTRUCTIONS 19 8 SAFETY MEASURES ee 19 8 1 USER PREGAUTIONS TTT E 19 8 2 ELEGTRICALEQUIPMENT et chet al E tab et 19 8 3 MECHANICAL EQUIPMENT RM 19 8 4 SAMPLES ANALYSIS 4 e Ei ELE o te ELEC GL tita d dt edet ete teet er 19 8 5 NOTES ON SAFETY MEASURES
29. l in which the tube was placed After inserting the sample a beep will confirm that the sample has been recognized and the instrument is ready to accept the next identification code see Figure 6 insert id Cesc to exit Figure 6 If all twenty channels are used and the analyzer is full the operator will not be able to input additional ID s and an Analyzer Full message will appear see Figure 7 To exit the screen press the ESC key OI fr e fr rn CO P3 HHHHHHHHHHHHHHHHHHH OOOOOOOOCOOOCOOOCOOOCO Analyzer full esc to exit Figure 7 After all ID s are entered return to the main menu to monitor the status of the analysis or before closing the cover to start the mixing process If the cover is closed while the analyzer is still in the ID mode mixing will not occur During analysis symbols are shown on each channel to indicate time remaining see Section 4 3 Pag 10 34 Vital Diagnostics MIX Rate X20 USER S MANUAL 5 1 2 Samples Identification Sub Menu Function 2 102 This function enables the operator to insert a series of sample identification codes following a work list Once the codes are entered the operator must transfer the samples to the channels relative to the identification codes This procedure is ideal when one has to transfer many samples from the external mixer to the instrument quickly
30. ls Close the cover to begin the mixing process ID2 Scan the bar coded samples in sequence or enter the ID s using the keyboard Then insert well mixed samples into any free channel ID2 Scan the bar coded samples in sequence or enter the ID s using the keyboard Then insert samples into any free channel and close the cover to begin the mixing process After 30 minutes or 15 minutes record the results Results will print if the printer is correctly configured in the setup menu If Host is connected and configured under setup the data will be sent to the host according to the set up configuration After results have been recorded remove the tubes will appear indicating that this position is free for introduction of next tube Follow points 3 5 for additional samples 8 SAFETY MEASURES 8 1 User Precautions Before using the analyzer the operator must know the rules for handling potentially infectious materials and for handling the electro mechanical systems 8 2 Electrical equipment As with all electrical equipment the power supply is a potential source of danger To prevent the risk of electrical shock to the user and or damage to the instrument the operator should not open the covers of live electrical parts of the instrument Only authorized personnel Vital Diagnostics Service Technicians may open the instrument to perform maintenance or repair 8 3 Mechanical equipment As a precaution do not open the instrum
31. lts seem to be wrong a Sample clot a Repeat sample collection b Sample has foam b Re mix gently c Sample measured after 4 E Repeat sample collection and hours from sample collection promptly process d Incorrect sample mixing d Follow mixing instructions found in Section 5 3 CCD Scanner does not read Scanner configuration wrong a Check setup and turn on barcode b Driver board malfunction b Call Technical Support Scanner malfunction c Call Technical Support b Configuration disabled Check setup Display background is dark a Power switch on a Switch power on b Power supply working 3 Check power supply E problem Call Technical Support IH battery discharged Technical Support Keyboard malfunction Keyboard broken Call Technical Support Clock battery discharged Call Technical Support 14 APPENDIX 14 1 Westergren Method This is the selected method in accordance with the National Committee for Clinical Laboratory Standards NCCLS It consists of a support that keeps the Westergren tubes containing anticoagulated blood perfectly vertical and hermetically sealed Westergren tubes have a diameter of 2 5 mm and are graduated up to 200 mm As soon as the sample is taken the venous blood is mixed with a sodium citrate solution in the ratio of respectively four to one 1 6 ml of blood 0 4 ml of sodium citrate The blood thus prepared and well mixed is drawn into a Westergren tube up to the zero mark The tube is placed
32. ndows systems have logged on as Administrator 14 6 1 Basic Procedure The basic procedure to setup an Mixrate X20 and a host system is Connect the two systems together Configure Mixrate X20 Configure host PC 14 6 2 Configuration The Mixrate X20 can be interfaced to an external computer system using a 9 pin serial cable The Mixrate X20 host settings can be configured in 3 modes these are No Yes or Auto In Auto mode the Mixrate X20 sends data when results are ready or the host computer can request a data dump of the complete Mixrate X20 memory by sending a character to the Mixrate X20 This request will be ignored if the Mixrate X20 is busy 14 6 3 Hardware Configuration The Mixrate X20 can be interfaced to an external computer system with a 9 pin Serial cable The cable configuration is Host Side Mixrate X20 Side Pin Pin 2 3 Both sides use female connectors 3 2 4 8 8 4 5 5 Press 6 from the Mixrate X20 main menu and set the host to AUTO 14 6 4 Software Configuration The host system uses a standard PC serial COM port configured with the following settings 9600 bits second 8 Data bits Pag 28 34 Vital Diagnostics MIX Rate X20 USER S MANUAL N No Parity 1 Stop bit Hardware handshake RTS CTS The host system must be configured to read data in the format described in Section C 6 This is the responsibility of the cus
33. ontrol of functionality 9 2 Limitations Strongly lipemic or hemolytic samples may alter reading capability Sedimentation rate values 140 mm h will be indicated with this mark 140 Temperatures outside the given range will be accepted as 15 C minimum and 32 C maximum Anemia under 2 5 million cubic mm RBC can give reading problems As with all ESR analyzers abnormally high or low hematocrits along with other hemoglobinopathies may affect results 10 TEMPERATURE COMPENSATION 10 1 Results correction to 18 C The results achieved are correlated to the method of reference considering the room temperature The Mixrate X20 constantly measures the internal temperature and normalizes the values at the temperature of 18 degrees according to the Manley table shown in 1 below This process guarantees better reproducibility instead of instruments which perform results without temperature compensation 1 Manley Table correct values casta Analysis Temperatures 18 15 18 20 25 30 5 4 6 8 10 9 10 10 12 16 20 18 20 21 25 31 30 27 30 31 37 45 40 36 40 42 49 58 50 46 50 52 60 71 60 55 60 62 71 82 70 63 70 72 82 93 80 72 80 82 93 104 90 81 90 93 103 114 100 90 100 103 114 125 Pag 21 34 MIX Rate 20 USER S MANUAL Vital Diagnostics Mixrate X20 converts the results to 18 degrees according to the table if room tempe
34. or 2 press enter and then replace the MEAN and SD with new values Once done press ESC to exit the menu see Figure 18 Pag 14 34 Vital Diagnostics insert id esc to enit Figure 16 toro Corno T Ig E Paro XM LOBI Mx ux Ds en Lun n eem PH M Dncom ios n T1 s a CO BC Spl Mean SD CUa 1 8 4 49 5 2 43 24 0 Figure 17 GC EDIT QC 1 Theor ID 1603108027 Mi Lot Calc Hr 4 3 5 43 5 ZO ro 3 Du 7 8 Use arrows to move Cent to change esc to Figure 18 Vital Diagnostics MIX Rate X20 USER S MANUAL 5 3 5 PRT Sub Menu Function 5 To print a list of recent OC results press 5 from the OC menu The results will print 5 3 6 QC DEL Sub Menu Function 6 To delete all of the OC data press 6 from the OC menu The operator will hear four shorts beeps followed by the message shown in Figure 19 Press ENT to delete the data or press ESC to abort and exit the menu 5 4 Printout Function 4 Print From the main menu press 4 to enter the print menu Using this command displays three options see Figure 20 5 4 1 W List Sub Menu Function 1 deleting GC data CENT to accept ESC to abortt W LIST RH MEMORY El MEMORY RANGE Figure 20 The W LIST enables the operator to retrieve a summary printout list of the samples currently being anal
35. pt ESCI to abortt Figure 10 Pag 11 34 MIX Rate X20 USER S MANUAL 5 2 2 Memory Sub Menu Function 2 Edit Vital Diagnostics This function allows the operator to edit ID codes along with the respective results Move the cursor to the sample to be changed press enter and then edit the ID code or the results see Figure 11 5 3 Quality Control Main Menu Function 3 QC o I I I i i t je CERTI CO 7 CP CTI E CO e Cas nico TJ C CTI CO PO I I Ii I I e e CONI Ee CO PO Cas Dc T JO CTI E CO P GC 2 6 li ri 15 ri z 25 38 36 42 45 53 6a ri r5 ri ER ri EIN Hr WEIEN Figure 11 The screen shown in Figure 12 will be displayed when Function 3 is pressed at the Main Menu Pag 12 34 ac QC QC QC 10 IMP Vital Diagnostics MIX Rate X20 USER S MANUAL 5 3 1 QC INP Sub Menu Function 2 This Function precedes Function 1 The lot number from the hematology control blood is entered using 2 QC INP This should be done every time a new lot number of controls will be used Press 2 enter the lot number for both the normal and abnormal controls found on the package insert then press ESC to exit The lot number has a checksum character to ensure that it is entered correctly Be certain to enter lot number exactly as written or the code will not be accepted When the new code is entered a
36. rature is within the range 15 32 C For lower or higher room temperatures the instrument converts temperature in this way 15 C for lower and 32 C for higher temperature 11 MAINTENANCE 11 1 Maintenance The Mixrate X20 does not require special maintenance due to the simplicity of the instrument and the component parts The most sensitive parts are the infrared sensors inside the instrument 11 2 Cleaning Instructions Dust can be removed using an ordinary vacuum cleaner Please pay attention to the cleanliness of the test tube positioning plate When not in use the positioning plate must be covered with the Plexiglas cover Do not clean the upper plate with liquids or damp cloths the entry of liquids or solid material into the channels can cause considerable damage to the instrument Pay particular attention to the test tube The cap must be tightly closed and the label must be positioned correctly and completely adhered to the test tube surface If not label fragments could fall into the test tube channel and obstruct a correct reading function during analysis 12 ERROR DISPLAYS 12 1 Result Data Error There is invalid data stored in memory Contact Technical Support Figure 24 self test results data error 12 2 QC Data Error check printer NE nas ical check host Links There is invalid data within the QC memory Contact Technical Support EE deleting results 12 3 Printer ENT to accept
37. s 8 6 Residual Risks Despite of the measures taken in the designing of the machine to guarantee a safe use of it there might happen reasonably predictable occurrences whose risk was possible to reduce but not to eliminate completely RESIDUAL RISKS PROTECTION MEASURES The operator must wear always gloves and Biological contamination protection glasses as prescribed by laboratory regulations Do not ever open tubes Insert and remove tubes from holes maintaining a vertical position without applying lateral forces Do not try to open the mixing panel in order to avoid tubes breaking Do not try to stop the mixing panel Do not try to insert any object between the mixing panel and the device in order to avoid mixing panel Mixing Panel stop damage and or tubes breaking Do not try to touch the internal moving parts when the mixing panel is open in order to avoid user and or instrument damage Tubes breaking Pag 20 34 Vital Diagnostics MIX Rate X20 USER S MANUAL 9 PERFORMANCE CRITERIA AND LIMITATIONS 9 1 Performance Criteria Level sensor for correct blood draw 1 00 to 1 40 mL Real time detection measuring points 10 point intervals Measuring range 1 140 mm h Graphic curve On printer and display Short time analysis 15 minutes Mechanical optical precision of detection 0 2 mm Automatic temperature correction to 18 C 15 32 Manley table QC software for daily c
38. s must be avoided This also applies to all components of the instrument that are exposed to these substances If any specimen is spilled on the instrument wipe it up immediately and clean the contaminated surface with a disinfectant of 0 596 sodium hypochlorite solution Compliance with local regulations pertaining to the disposal of waste is the responsibility of the operator Refer to local sources for additional information on Pag 19 34 MIX Rate X20 USER S MANUAL Vital Diagnostics correct biohazardous waste disposalQualified technical operators must apply the same warning procedures for instrument maintenance 8 5 Notes on safety measures The operator must pay a special attention to the sample collection Must use the correct vacuum test tubes described for this eguipment in this manual since these tubes have been studied to aspirate the right level of blood Every attempt to put the blood into test tubes different to the one described brings serious dangers of infection due to the risk of sample coming out and this moreover will damage the optical part inside the instrument and provoke the loss of the guarantee Refer to the tubes manual to have more details On the instrument to assure a correct use of the instrument may be placed the following symbols IVD Attention read use instruction For in vitro diagnostic use only 4 ELECTROSTATIC DISCHARGE SENSITIVE DEVICE ESDS f The device could be damaged by electrostatic potential
39. screen similar to Figure 13 will appear CAUTION When a new code is entered and accepted the stored QC data will be erased Therefore before deleting stored QC data 1 must be pressed in order to confirm the deletion of this stored data If you wish to print out this data and do not wish to delete at this time Press ESC to exit now If 1 is pressed the screen shown in Figure 14 will appear Press ENT to confirm the entry of the new control information and the deletion of the old data This will return you to the QC menu 5 3 2 QC ID Sub Menu Function 1 Once the lot numbers for the QC controls are entered using Function 2 QC INP the Mixrate X20 is now ready to measure QC controls and store the results To identify that a control is being measured enter the identification code using the QC ID Function 1 before inserting the control samples into the instrument Entering the QC ID code will indicate to the Mixrate X20 that the next sample placed in the instrument is a control sample The QC identification code is the lot number found on the package insert DC CONTROL CLEAR OLD QC DATA PRESS C1 TO DELETE insert id 2421095013 Cesc to exit Figure 13 CENT TO CONFIRM insert id 262185813 Cesc to exit Figure 14 insert id esc to exit Figure 15 Pag 13 34 MIX Rate X20 USER S MANUAL Control samples may be inserted in any chann
40. stics or by inappropriate use The analyzer and accessories are shipped in transport boxes and should be unpacked and installed using instructions supplied by Vital Diagnostics If these instructions are not observed Vital Diagnostics assumes no responsibility for consequential damage or improper operation of the analyzer 1 1 Operator Qualification The instrument should only be used by qualified and trained personnel For clinical tests the instrument should be used under the management of a doctor or qualified laboratory technician technologist in compliance with CLIA and local regulations 1 2 Analytical Results The analytical results depend upon not only the correct operation of the analyzer but also a variety of external influences beyond the control of the manufacturer Therefore a qualified clinician must carefully examine the test results obtained with this instrument before any diagnostic or therapeutic measures are taken based on the analytical results Caution An incorrectly measured result may lead to an error in diagnosis Technical Service Service to the instrument must be performed by local distributor service representative Service provided by other person s will invalidate the warranty Pag 6 34 Vital Diagnostics MIX Rate X20 USER S MANUAL 2 INTENDED USE The MIX Rate ESR analyzer is an automatic instrument for the analysis of the erythrocyte sedimentation rate lt constantly and simultaneously scans 10 test
41. te Connectors are 9 pin female 2 3 ge 2 die 8 8 4 5 5 14 5 4 HOST CONNECTOR SIGNALS DESCRIPTION Data format is 9600 bps 8 data bit 1 stop bit no parity hardware protocol RTS CTS In order to make this document clear the character tilde is used in place of a space when there is more of one space and spaces are important for data collection Control characters sent by the instrument is STX code 2 decimal in this document replaced by the string STX ETX code 3 decimal in this document replaced by the string ETX 14 5 5 HOST DATA TRANSMISSION REQUEST FROM HOST COMPUTER The host computer could require data transmission by sending the character Data transmission starts only if the operator is not using the instrument If the instrument still executing a command menu characters will not be transmitted 14 5 6 MESSAGES SENT IN THE BEGINNING Instrument model MODEL 1 0 Note The model name and version of the software can be different Device configuration MODE 15 T CORRECTION ON MODE 30 T CORRECTION ON or MODE 60 T CORRECTION ON NOTE Values 15 30 and 60 depend on the analysis time mode respectively 15 30 or 60 The string T CORRECTION ON is transmitted only if the temperature correction is enabled Date and Time DATE GG MM AAAA HH MM Operating temperature TEMPERATURE gg rC where gg r is the operatin
42. tomer or host PC vendor The test procedure described in section 4 will verify that the Mixrate X20 is transmitting data to the host PC Pag 29 34 MIX Rate X20 USER S MANUAL Vital Diagnostics 14 7 Data format amp example data file 5 1 The data format sent out by the Mixrate X20 consists of the following format STX message ETX and a Checksum derived from message amp ETX 5 2 Startup message On startup the Mixrate X20 transmits The model number and version of software The device configuration analysis time mode Date amp time Operating temperature Some of the above are optional and depend on instrument settings 5 3 The file shown in FIG 34 is an example transmission from the Mixrate X20 For the first sample the Sample ID number is 4037340 the sequence number is 2 1 and the result is 62 BOLD STX amp ETX UNDERLINE Checksum Black data Grey Next sample data Hex ASCII 02 20 20 32 20 20 31 20 34 30 33 37 33 34 30 2E 2 1 4037340 2E 2E 2E 2E 20 20 20 20 20 20 36 32 20 20 20 20 e D 20 03 31 39 02 20 20 33 20 20 32 20 34 30 33 38 19 3 2 4038 30 32 31 30 31 2E 2E 2E 20 20 20 20 20 20 20 37 02101 7 20 20 20 20 20 03 30 43 02 20 20 34 20 32 34 20 0C 424 34 30 33 38 32 37 33 2E 2E 2E 2E 2E 20 20 20 20 4038273 20 20 20 37 20 20 20 20 20 03 32 35 7 25 Fig 26 Sample Transmission 5 4 Checksum calculation In the example of FIG 34 the checksum is 31 39 This is derived by Adding all the
43. tubes which are custom made for ESR analysis The MIX F follows the sedimentation of each sample independently memorizing levels for the whole period of analysis di IMPROPER USE Following uses are considered improper 1 Use of the device to obtain results different from ESR 2 Use tubes different from those specified in this manual 3 Every attempt to open tubes analyzed by the device 4 Use the device to analyze samples different from those specified 5 Every attempt to open the mixing panel when it s closed or to block its Movement The above mentioned uses and every attempt to use the MIX Rate X20 ESR analyzer with a purpose different from the intended use must be considered improper 4 INSTALLATION 4 1 Placement of the Analyzer The Mixrate X20 must not be placed near centrifuges oscillating agitators or other vibrating instruments which might cause movement of the bench Please keep in mind that the ESR instrument is very sensitive to vibrations which could cause a false increase of results The workbench must be flat and leveled Direct light on the instrument and sudden changes in temperature should be avoided 42 Configuration Mixrate X20 will be supplied factory configured 4 3 Power on Connect power supply outlet to the instrument Insert the power supply plug into the electrical socket ia Once connected turn on the Mixrate X20 using the switch situated at the rear side of the instrument k A A k GN det
44. yzed Press 1 to print 5 4 2 Memory Sub Menu Function 2 Pressing 2 prints out a list of all samples analyzed and held in memory 5 4 3 Memory Range Sub Menu Function 3 Pressing 3 allows the user to enter a range of results to print from memory see Figure 21 Insert the sample number to start from in the From field and press ENT Insert the ending sample number in the To field and press ENT Printing will start automatically Pressing ESC without entering the From and To fields aborts the function PRINT Memory position From To Pag 15 34 MIX Rate X20 USER S MANUAL Vital Diagnostics 5 5 Host Function 5 Host To transmit data press 5 from the Main Menu Press ENT to send the data or ESC to exit the menu Sending head 6 SYSTEM DESCRIPTION Figure 22 6 1 Mixrate X20 Analyzer The Mixrate X20 ESR analyzer is an automated instrument controlled by a microprocessor and exclusively employed for analysis of the erythrocyte sedimentation rate ESR Its precision and its ability to obtain results corrected to a temperature of 18 C according to Manley in only 30 minutes make the Mixrate X20 an innovative and versatile system for this kind of analysis It simultaneously scans 20 test tubes which are custom made for ESR with this system Mixrate X20 follows the sedimentation of each sample independently The instrument can be used for random and continuous loading of samples to a capa
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