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GLOBAL 300

1. search criteria By Patient No Fro To mE By ID By Name white In any case to print the report it s necessary that the operator once established the parameters of the search criterion desired clicks on the Search key The report or the reports will be printed automatically To escape from this function click on the Exit key Its also possible to print the work lists related to some or to all the tests entered for the patients in memory To print the work lists related to some tests it s necessary to select the desired tests before therefore click on the key Print Selected Tests Cr cux EB cox sui cor cer vax Ger are soo cmm rer ca ca me mr m x fioa ar Gu en pen asc mo na 111 O E E E AU RS O HA O HS IS SS IS E i i Pint Today s 5 Tesi Frid Print Pasari List ay ere Aes zioni TEST Prol l Pini Feriis Est GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 50 of 78 OPERATING ROUTINE Otherwise to print the work lists related to all the tests present for the patients in memory simply click on the Print Today s Tests key without any previous selection of tests Finally we have the functions related to the plain printout of the results for each test executed These printouts are useful in case the operator needs to transcribe the results in an external management system whenever a bi directional on li
2. 11 12 likely to be walked on or pinched by items placed upon or against them paying particular attention to cords at plugs convenience receptacles and the point where they exit from the appliance Cleaning The appliance should be cleaned only as recommended by the manufacturer Non use Periods The power cord of the appliance should be unplugged from the outlet when left unused for a long period of time Object and Liquid Entry Care should be taken so that objects do nat fall and liquids are not spilled into the enclosure through Heat The appliance should be situated openings away from heat sources such as radiators 13 Damage Requiring Service The heat registers stoves or other appliances appliance should be serviced by qualified Power Sources The appliance should be service personnel when the instrument connected to a power supply only of the does not appear to operate normally or type described in the operating instructions exhibits a marked change in performance or as marked on the appliance or the instrument has been dropped or the Grounding or Polarization The enclosure damaged precautions that should be taken so that 14 Servicing The user should not attempt to the grounding or polarization means of an appliance is not defeated Power Cord Protection Power supply cords should be routed so that they are not GLOBAL 300 USER S MANUAL Rev lux 02 05 service the appliance beyond that des
3. e o Wh Dial ion E The test or tests selected will appear with the indication RERun instead of the result previously present Finally 1f the operator selects a test and then he clicks on Repeat Test key this test will be repeated for all the patients present in the memory In case the repetition 1s executed within the analytical routine the instrument will complete the routine job before executing the repetitions which are always performed at the end of the analytical routine In case the repetition is executed outside of the analytical routine to start the repetitions it will be necessary to start a new routine proceeding as indicated in the section Start Routine although 1t will not be necessary to enter patients Note in the reports printout the result which will be printed on a report for a certain test is the last one obtained in case of repetition of such a test Note the results obtained for a test before its repetition are not cancelled or overwritten but are still available for an eventual verification by the operator These results can be visualized by mean of the Patients List function by selecting the repeated test and therefore by clicking on the Details key it will appear the mask related to the results obtained for each repetition of that test GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 43 of 78 OPERATING ROUTINE To display the different results obtained by the first execution and then by the s
4. Before entering the patients data the operator shall open the main cover of the instrument this will interrupt the sampling process but not the reading process Then the operator enters the data related to the new patient specifying if it s a standard patient or a STAT patient and after he shall click on the Next key and eventually enter other patients Once completed this operation he shall click on Exit key to return to the Patients Menu where the new patients are displayed on the samples tray in the positions where these must be placed The operator can now place the new samples on the tray as the sampling process is halted Once positioned the samples on the tray the operator can close the main cover and then he must click again on the Start key to enter the routine mask and click on the Continue key to restart the routine Note in case the operator closet the main cover but he doesn t restart the routine by clicking on the Continue key the instrument will complete the readings in progress therefore it will stop the routine and return to the Main Menu The operator shall then restart the routine which will reprise from the point it stopped including also the new patients just entered GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 40 of 78 OPERATING ROUTINE 3 4 REPEAT TESTS After the routine has been completed or also when the routine 1s in progress the operator has got the possibility to examine the results and eventually repeat
5. 007 E 1244 bil Enc F Bil Direrra AC UHLDcO nilssi CFE HAT i LEH P CLora Cmlcin Hare sium romr2nc IT proceine Co lamterolo HDL Rl Eos Vial Vol EE Pos Vial Vol Factor case at the moment the operator clicks on OK it appears the following Mr Test 32 B isse x i id I Lara mr un Operi Crank AE ye Li 2 E gt gt 28 al E MW x Cr fn Caba air Patents Enim odas Sakri Tazi CE rium Ek daa ti i Carcal Close the main cover and click on OK the instrument will therefore start the routine GLOBAL 300 USER S MANUAL Rev 1ux 02 05 Page 36 of 78 OPERATING ROUTINE On the screen during the operations will be displayed all the operations performed such as the sampling the reading and so on In the routine mask are available some function keys which allows the user to perform some operations while the instrument is operating Hee OK Waste DE Tempo Rimansnte uv Zero fies from 25 Ta 45 The operator can therefore add serum to a sample cup if the level detector warns him about the eventual low level of the sample in such a case he shall click on the Add Sample key the following mask opens Basing on the legenda present on the upper right part of the screen the samples whose volume is insufficient appear in red colour on the tray and moreover they are listed on the left column The operator must add serum to the samples indicated and therefore click on Ex
6. to the 100 transmittance of light through the cuvettes Once the system has completed the operation on the screen it will appear the following list of all the voltages for each filter and for each cuvette CE Filter e Cavetk UTOZERO performed ee CAN AE A ERA AE TS EIA O TEA RE Ros A TS MPAA i i E a e RIO Cuwerre Offset 340 405 505 546 570 azi 280 450 300 ul 2 510 2 510 2 510 2 510 2 510 2 510 2 510 2 510 2 510 2 510 dz 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 03 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 04 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 05 0 000 0 000 0 000 0 000 0 000 0 000 4 000 0 000 0 000 0 000 Ua 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 o7 0 000 0 000 0 000 6 000 0 000 0 000 0 000 0 000 0 000 0 000 Da 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 n3 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 10 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 11 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 du 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 a 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 14 0 000 0 000 0 000 0 000 0 000 0 000 0 000 06 000 0 000 0 000 15 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 60 000 0 000 15 0 000 0 000 0 000 0 000 0 000 0 000 1 000 6 000 0 000 0 000 We 0 000 0 000 0
7. 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 18 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 la E 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 E 20 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 21 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 za 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 23 0 000 1 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 0 000 hinihodz Esaculs Eval The GLOBAL 300 is at this stage ready to start the routine NOTE It s recommended to perform at least another AUTOZERO cycle during the working day GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 17 of 78 OPERATING ROUTINE 3 OPERATING ROUTINE 3 1 ENTER PATIENTS amp REQUESTS The first operation to perform is to enter the patient s details by entering in database of all patients details and tests requested for the samples to be analysed To access to this function click on the Patients key located on the lower part of the screen of the Main Menu the following screen will be displayed Enter Repeat Text EE On the lower part of the screen there are some command keys which allow the operator to perform several additional functions or options This key allows the operator to set the tests and the samples to be repeated This key allows the operator to enter the archive functions such as retrieving and or reporting patients
8. Est At this stage he can select the function to activate by clicking on the corresponding key In case he wants to modify the method selected he will click on the Modify View Test key and therefore the screen will display the different pages for the test s parameters These parameters will be better explained in the section 5 3 GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 66 of 78 5 2 DEFINE A NEW METHOD METHODS PROGRAMMING If the operator wants to define a completely new chemistry without modifying any of the existing ones he shall click on the New Test key the following text box appears on the screen Then the operator shall simply type in the box a three letters code to define the new chemistry therefore once he clicks on OK the parameters windows will appear 5 3 METHODS PARAMETERS Here are the several windows which are accessed whenever the New Test key or Modify View Test key are clicked by the operator This is the first parameters window Code Unite Minimum Value Min 7 Blank OD Decimal Figures 1 24 872 Jl GLOBAL 300 USER S MANUAL Method T Rev lux 02 05 Tray Linearit Limit Maximum Value Max e Blank OD Mixing STD Lot No 0 Ye 1 Dilution Beag Code Page 67 of 78 METHODS PROGRAMMING Here are the parameters of the first window with the related explanations This is the test code which appears in the tests grid Typically th
9. an ENQ every 10 seconds Transmitting Mode Receiving Mode GLOBAL 300 COMPUTER Connection Established Reswm OO If Data String accepted BCC Ok If Data String not Accepted BCC not Ok Res String B If ACK is received send following data string Res String A If NAC is received Resend data string If no further data string present AAA A E A UI GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 77 of 78 APPENDIX APPENDIX A DATA STRING FORMAT Every data string consists of STX data BCC ETX The data are only ASCII printable characters included between ASCII 32 and 255 BCC is composed of 2 ASCII characters representing the sum of all the characters in the data string excepting the STX BCC and ETX characters This sum shall be expressed in Hexadecimal notation HEX A Patients Data String From LMS N of Characters 8 39 3 3 3 3 121 B Results Data String From G 300 N ofCharacterss 8 9 3 9 3 9 2 NOTE No space between each character of the strings Result is code in the following format XXXX XXXX 9 characters including decimal point ASCII Characters used in communication STX ASCII 2 decimal ETX ASCII 3 decimal EOT ASCII 4 decimal ASCII 5 decimal ASCII 6 decimal NAC ASCII 21 decimal GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 78 of 78
10. analyser are available TIC RR Si To access these functions position the pointer of the mouse on the key corresponding to the function desired and click on the mouse s left key GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 13 of 78 PRELIMINARY INFORMATION 2 4 INSTRUMENTS INSTALLATION Wash and fill up with distilled water the reservoir located in the front right part of the instrument therefore empty and wash the waste reservoir located beside the water reservoir At this stage before starting the analytical routine with the instrument it s necessary to perform some preliminary operations to set up the optimal operating conditions of the analyser Using the mouse select the sub menu SERVICE on the lower part of such menu there are several keys to access some additional functions Washing System Reaction Tray Reset Washing Arm Ca Reset cuvettes Tray Reset Barcode Motor T Reset vertical Movemen Reset samples Tray M Photomete P Frobe washi piluter E UD Wastes Probe wash Pump E Reset Diluter EN Probe Washing Valves o M valve OFF Sess Lega Salar The function keys available are the following This key allows the operator to change the language of the instrument s menus To make Language any language s change effective the operator must restart the instrument Selection This key launches the routine which set all the steps nee
11. be used for the statistical calculation on the screen will appear the related values in the left column while on the right appears the related Levy Jennings graph and below it the values obtained for the SD and the CV related to the series of results obtained for the control sera selected To escape from this window click on the Exit key Can be displayed also the mask related to the values of absorbance of the reagent blank obtained during the calibrations of the selected test and to the related statistical calculation furthermore the statistical calculation can be performed also on the several calibration factors obtained during the calibrations To visualize such data the operator shall click on the OD Blank Factor key therefore proceed as for the visualization of the data related to the control sera DE b Ss anal Farkas Test GPT ALT 1232 From 01 01 Toi RIP lo Of Data 4 Mean 1 00 pes 0 00 CY 0 00 GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 58 of 78 SPECIAL FUNCTIONS Finally a further function available in this section 1s a function which allows the operator to perform a statistical calculation on a series of data he can enter directly To access such a function the operator shall click on the Manual key 1t appears the related window therefore he shall click on Enter Values key to open the entering mask where he shall type in the values to be used for the statistical calculation Then after having typed
12. of absorbance of the reagent blank only reagent under which the reagent cannot be considered working correctly This Max Reag Blank OD value is normally pre programmed for BPC reagents otherwise to obtain such a value for different reagents it s suggested to contact the reagent s manufacturer Here the operator can define how many decimal figures will be displayed for the result and therefore will be used for the calculation Decimal Figures Note that the upper five rounding method is applied therefore whenever the operator selects i e 2 decimal figures in case the calculated result is 1 365 the value effectively displayed will be 1 37 Here the operator can select whether he want the system to perform a Mixing N20 Y 1 further aspiration and dispensation of the reaction mixture into the reading cuvette in order to have a better mixing of reagent and sample STD Lot Here the operator types the lot number of the standard used either for clinical chemistry tests and immunoturbidimetric tests X This 1s the dilution rate to be used in case of repetition with dilution of Dilution 2 4 m SM a test for a sample This is not a pre dilution rate This code is extremely important as it shall correspond to the code expressed by the barcode of the reagent In case these two codes do not Tray Linearity Limit Reag Code match the barcode reader will not be able to determine that the reagent present in the tray 1s the rea
13. or large electric heater are connected If you use the GLOBAL 300 in an area with a different power voltage first consult your dealer or the nearest BPC BioSed service station You can use the GLOBAL 300 with a power frequency of 50Hz or 60Hz It 1s very dangerous to use a power cord that is frayed or damage In such a case stop using the GLOBAL 300 immediately and ask your dealer to repair the cord To avoid possible electric shock and damage to the GLOBAL 300 do not Rev lux 02 05 handle the power plug while your hands are wet To prevent possible electric shock and damage to the GLOBAL 300 do not remove the main unit cover or reach the inside the GLOBAL 300 Do not let water or other liquid or metal objects such as pins accidentally enter the inside of the GLOBAL 300 because this may lead to electric shock or damage Should water enter the inside of the GLOBAL 300 remove the power plug from AC outlet and consult your dealer or the nearest BPC BIOSED service station Important Equipment name electrical ratings serial number and other information for the GLOBAL 300 are written on a plate inside the reservoirs compartment Note on repair The GLOBAL 300 does not use any parts that user can repair easily Contact your dealer or the nearest BPC BIOSED service station to ask about repairs Use the packing carton designed for the GLOBAL 300 when you transport the GLOBAL 300 to the dealer for repair or retu
14. the related requests click on the Reg Patient key on the screen will be displayed the Patient s Entering mask Patient Wo 3 P STAT t OFF Ling E EF Petar E Control 4 BDO rani cex nom r cx ca me em e rea CACI cue ce aso mon sa A am EI T e ALC Lora eca ion Pa eel Pio Sa ented Cano Pst be ok Pater Esi On this mask we have also another set of keys which can give access to further functions related to this operation The keys available are the following This key enters the On Line communication function allowing the download of patients from an external computer connected to the serial port of the External Comunication Management Computer of the instrument co This key stores the patient s data and requests and goes to the next available record Bio where a new patient will be entered Eno This key pages to the record of the previous patient to verify the entered data or eventually to modify them Previous This key allows the user to select the tests without clicking directly on the tests grid By clicking on this key a test box is opened and here the operator can type the codes of selected the desired tests GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 19 of 78 OPERATING ROUTINE This key allows the user to delete the current record and therefore all the contained patient s data and requests This key allows the operator to copy the patient s data and r
15. those test whose results are not corresponding to an eventual clinical pattern for that patient The repetition of tests can be done during the routine by clicking on the function key present on the lower part of the Patients Menu or outside the routine once all the results have been printed and therefore the operator can have a better overview of the status for each patient To perform repetitions while in Main Menu the operator shall click on Patients key and then again on the Repeat Tests key Hr paatu Pat Cap ID Ham TEST Paz B 1 RN Ll La iii Mlt Dai 2 002 Andrew Red DDd 3 10053 ruig Black al aj ad Dicen ica Cd en Asta all den cioe Pepesi Pod era eng T Exi In the lower part of the mask the operator can select the type of repetition to execute if standard or with dilution the dilution ratio specified in the method is used The default option is standard without dilution between reagent s volume and sample s volume the result obtained is therefore The repetition with dilution of a certain test is performed by changing the ratio multiplied by the dilution ratio applied The operator has got therefore the following options related to the repetition of eventual tests Repeat all the tests of all the patients present in memory which are listed on the mask Repeat a single patient with all 1ts tests Repeat only the selected tests for a patient Repeat a single test common for all patien
16. to which number of patient he wants to print the list moreover it s possible to select the printout of the list without including the tests for each patient but only the demographic data By clicking on By Patient key the operator launches the printout otherwise by clicking on All key he launches the printout for the list of all the patients GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 48 of 78 OPERATING ROUTINE By clicking on the Print Results key the following mask related to the search options for the patients whose reports are to be printed appears on the screen Prist Fue ports Ssacch Criteria By Patient Wo Fro m eM C E at It s possible to select three different search criteria to select the patients whose reports shall be printed The criterion by Patient Number requires the operator to specify the initial number and the last number of patient the reports of the patients in between such interval of numbers will be printed It s also possible to perform the search of the patient by specifying his ID in such a case the operator shall type the ID of the patient whose report shall be printed in the apposite text box search Criteria By Patient No Eto By ID adl Ey Name TO GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 49 of 78 OPERATING ROUTINE As last search criterion it s possible to specify the name of the patient whose report has to be printed
17. which however are available for the tests the operator shall therefore verify the volume of reagent effectively present in the reagent container and confirm it GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 33 of 78 OPERATING ROUTINE This can be done by typing directly such a volume into the apposite text box or activating the functions related to the level detector and to the Automatic Volume CK Such functions can be activated in the Set Steps Menu which can be accessed by the Service Menu Select setting 2 05 oA M wettes mr TT eg Hed Up Mov from GK Lip Hur 3 8 9 sample i 4 Fangen Dalai Barcode Reader Recon Descent on _ i CK Dun Ma Pa sample Sar D i Fisaganiz Dk Simply click on the buttons on the right lower part of the mask the two buttons to be activated are the following Reagent Detector and Automatic Volume CK Once activated these functions the colour of the LED on each one of the activated buttons becomes green therefore click on Exit twice to return to the Main Menu If the operator doesn t want to use the function Automatic Volume CK he can activate only the function Reagent Detector this to have however the check for the presence of the reagent Therefore from the previously displayed Start Routine mask he can verify the volume of reagent present for each one of the tests present in the mask In case the volume of reagent is not enough to perform all t
18. 10 undiluted GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 75 of 78 APPENDIX APPENDIX A ON LINE COMMUNICATION PROTOCOL INTERFACE The Standard Serial Port needed for the connection to an external computer on which runs a Laboratory Management System is located on the External Computer used to control the GLOBAL 300 analyser EXTERNAL Serial Port GLOBAL 300 MANAGEMENT COMPUTER SYSTEM j Transmit Receive 3 Receive Transmit Ground RS232C Serial Setup 19200 BAUD 8 data bit I stop bit no parity GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 76 of 78 APPENDIX APPENDIX A COMMUNICATION PROTOCOL If the Laboratory Management System LMS wants to send data to GLOBAL 300 1t must send an ENQ If the GLOBAL 300 is in receiving mode it will answer with an ACK therefore the LMS can begin to send the data strings Transmitting Receiving Mode Mode COMPUTER GLOBAL 300 ACK Connection Established Data String A Data String B NQ ACK ACK If Data String accepted BCC OK NAC f Data String not Accepted BCC not OK Data String A f ACK is received send following data string f NAC is received Resend data string f no further data string present LII pd j p o m If the GLOBAL 300 wants to send the results strings to the LMS first it will send an ENQ If the LMS is in receiving mode it will answer with an ACK If no ACK is received the GLOBAL 300 send
19. BioSed GLOBAL 300 Discrete Random Access Analyser BE pene VEBF ITT T REB mu a Serer ernie USER S MANUAL Rev lux 02 05 SAFETY INSTRUCTIONS PRECAUTIONS CAUTION RISK OF ELECTRIC SHOCK DO NOT OPEN CAUTION TO REDUCE THE RISK OF ELECTRIC SHOCK DO NOT REMOVE COVER OR BACK NO USER SERVICEABLE PARTS INSIDE REFER SERVICING TO QUALIFIED SERVICE PERSONNEL The lightning flash with arrowhead symbol within an equilateral triangle is intended to alert the user to the presence of non insulated dangerous voltage within the product s enclosure that may be of sufficient magnitude to constitute a risk of electric shock to persons The exclamation point within an equilateral triangle is intended to alert the user to the presence of important operating and maintenance servicing instructions in the literature accompanying the appliance SAFETY INSTRUCTIONS Read Instructions All the safety and operating instructions should be read before the appliance is operated Retain Instructions The safety and operating instructions should be retained for future reference Heed Warnings All warnings on the appliance and in the operating instructions should be adhered to Follow Instructions All operating and use instructions should be followed Ventilation The appliance should be situated so that its location or position dose not interfere with its proper ventilation 10
20. NTER MANUALLY RESULTS ennt 46 3 6 VIEW AND PRINT RESULTS en 47 A SPECIAL FUNC TIONS sa 52 4 1 COPY ONE PATIENT S DETAILS ON FOLLOWING PATIENTS 52 4 2 RECEIVE PATIENTS AND TRANSMIT RESULTS 53 4 3 SELECT PRINTER nenea nana nne ana nana 54 4 4 CREATE MODIFY LABORATORY HEADER HtHH H 54 4 5 CREATE MODIFY PROFILES nenea ana ana ana 55 4 6 QUALITY CONTROL o i a a i du 56 OA III i n a i i M i iu n i ee 60 4 8 PREDILUTIONS pp 63 GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 4 of 78 TABLE OF CONTENTS 5 METHODS PROGRAMMING Qeesseooeesessvvveessesvvvveeseevveveeesenvnnveensennnneeesennenseee 65 SNOEN TONNS EE 65 4 DEFINEANEN ME THOD se 67 2 9 METHODS PARAMETER Saa 67 6 ORDINARY MAINTENANCE cosa dis 73 GL WASHING RUNG TIONS sr 73 0 PRIMING DILUTER SSYRINGE LS 74 6 3 ORDINARY MAINTENANCE REPLACEMENT CHART 75 APPENDUEN Josie do eite nt n EI RD INEL liinda 76 APPENDIX A uie dar EE Edi p he 77 MENDES 78 GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 5 of 78 BASIC INFORMATION 1 BASIC INFORMATION 1 1 INTRODUCTION The GLOBAL 300 is a discrete Random Access analyser with microprocessor control The instrument is available as bench top or stand floor version The tests routine is random patient by patient with the possibility to enter at any moment of the routine new patients as standard patients or as STAT samples Reading is performed b
21. The GLOBAL 300 uses a serial port RS 232C for the connection between the A external computer and the internal CPU into the instrument It s therefore necessary to have enabled a second serial port RS 232C to be able to connect the system to a host computer In case there is not installed the second serial port the system will prompt on the screen an error message box Patient Mo 5 I STAT C OFF Line ID Patan WHEEL Jj E mi Control 4 EXESERESEXEXARAE IAE TE IE For the Communication Protocol needed to implement the connection on line with an existing software please refer to the Appendix at the end of this manual GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 53 of 78 SPECIAL FUNCTIONS 4 3 SELECT PRINTER To operate correctly the Global 300 instrument requires a printer to be connected to the managing external computer Even if there is not any printer connected it s necessary to install a file printer in Windows before launching the program and therefore operating the instrument To install the printer use the apposite option of Windows XP or 2000 Important Printer s selection must be made before starting the Global 300 management software this because if the system doesn t detect any printer connected it doesn t start 4 4 CREATE MODIFY LABORATORY HEADER Under the Patients Menu there is the function which allows the operator to modify the laboratory header which will be printed on all the report
22. al archives If the operator clicks on the NO key all these patients and related data will be erased completely without any possibility of retrieving them later If the operator clicks on the YES key all the patients in memory will be stored onto a definitive archive file which will be able to be retrieved whenever needed GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 20 of 78 OPERATING ROUTINE Once performed a choice on the screen appears the following message box Patient No GE m im Potent iii dna II Si v fT Conral4 apa asa a o ala 2 la TED eM oe TEL GIIA AU em Pa En Aaj gt el laaj Now the operator is prompted to save the samples in memory which have not been processed yet If the operator clicks on YES these will be assigned new progressive numbers and therefore will be added to the new patients which are going to be entered If the operator clicks on NO these patients will be discarded definitively without any possibility to be retrieved Once performed one of these choices on the screen appears the last message box C STAT Patient Mo 5 OFF Line ID E Patient i Cartmi 3 imr ENE NEDENES DENE RE ME SEES Fed Press E mda ci Cancel F enis Copa linii soba Patent This is a confirmation message at this stage the operator is still on time to change his decision to delete all the patients GLOBAL 300 USER S MANUAL Rev lux 02 05 Pag
23. ay 1t EA AA Once checked visually the patients entered it s possible to display the list of the patients with the related details for each one of them the operator shall in this case click on the Patients List key Repre Tes Reg Parks Pat Gap ID NTT 00231 2 1002 Andrew Red By clicking on each patient on the right column the tests selected for the patients will be displayed moreover in case these tests have been already performed the related results are displayed beside each test code GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 32 of 78 OPERATING ROUTINE It s also possible to display the Absorbance s values for each test in case it s been performed already this is achieved by clicking on a test to select 1t 1t will appear white on a blue strip background and then click on the Details key ID qas Tess e aia eee AT 0 0000 0 0000 3 0 0000 0 0000 E 0 0000 0 0000 ee To return to the Main Menu simply click on the Exit key to return to the Patients Menu and again to return to the Main Menu At this stage the operator can start the analytical routine by clicking on the Start key the following window will appear Bl Bos ial Yol Az Boet Vial Vol Factor WE AZOTERIA Gznps Crumncinina ITBIGLYSER BLITS HT GPT ALT A 1162 Fnsf klcslins HOT E i346 T proteins colesterolo HEL On the screen appear all the reagents present on the reagents tray or
24. cking on the Delete File key Once selected an archive file on the upper part of the screen the operator can visualize the list of the patients and their tests with the related results present on that date by clicking on the Patients List key 1t will appear the list related to the selected date Patre Led Pat Cap 1D m La i aaz Ham l Test Pat No 1 IJahn Smat George Washington am y Pa iub Archive on Date 02 15 2005 Arc GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 61 of 78 SPECIAL FUNCTIONS It s possible to print the list directly from this window by clicking on the Print key otherwise escape from this window by clicking on Exit key Anyway after having selected the archive file if the operator wants to print the report of some patients he shall follow the same procedure described in the previous section There is another archive area available in the software this 1s the archive for the methods Considering that on the tests grid in the Methods section there are only 96 positions available only 96 tests at a time are available to select the tests which are needed for the patients Anyway the number of tests which can be programmed on the instrument is much higher as the tests which are not going to be used continuously or which have been replaced by new ones can be stored into an archive appositely available for the methods From this archive the methods can be retrieved vis
25. cribed in the operating instructions All other servicing should be referred to qualified service personnel Page 2 of 78 SAFETY INSTRUCTIONS PRECAUTIONS Precautions upon handling Before you change the location of the GLOBAL 300 pack the unit in the shipping carton or an impact resistant case Make sure that the GLOBAL 300 is kept free from external impact Do not install the GLOBAL 300 in locations subject to the following Extremely high or low temperature or significant changes in temperature Excessive humidity or dust Excessive changes in power supply voltage Near a strong magnetic field such as a RMN units If you move the unit from a place with an excessively low temperature to a warm place or if you use the GLOBAL 300 in a room in which the temperature varies significantly during winter condensation may occur on the hard disk or other parts In such cases leave the GLOBAL 300 for about an hour in the new location before you turn on the power About power supply GLOBAL 300 USER S MANUAL Be sure to connect the GLOBAL 300 to the power supply specified in the Specifications section of this owner s manual Do not use an AC outlet of any other voltage Do not connect the GLOBAL 300 to the same AC outlet to which devices that could generate noise such as a large motor or dimmer or the devices that consume a large amount of power such as an air conditioning system
26. cription and Tray are common for all the windows Here the operator defines the type of reaction which is going to occur this can be 1 End Point 2 Kinetic 3 ISE 4 Initial Rate or 5 Differential or with sample blank This parameter defines the calculation mode which will be applied to the reading points Here the operator defines the time during which the reading will take place Note that cycle of the instrument is 12 seconds and therefore the time will be recalculated as multiple of such time despite the value typed in here Here the operator defines the time between the sampling of reagent and sample and the first reading Note that cycle of the instrument is 12 seconds and therefore the time will be recalculated as multiple of such time despite the value typed in here Here the operator defines the time after which the reagent 2 is added Note that cycle of the instrument is 12 seconds and therefore the time will be recalculated as multiple of such time despite the value typed in here Primary wavelength used for reading Secondary wavelength used for reading First Reading Time Time after which is performed the first reading minimum 60 seconds Substrate Depletion Value under which substrate depletion occurs kodes This is the direction of the kinetic reactions this value can be 0 for Reac Direct decreasing reaction whose absorbencies have a decreasing trend or can be 1 for the reactions with an increasing trend Ranco H
27. culating between the walls of the carousel keeps the temperature stable with variations of 0 1 C while an automatic washing station allows the reuse of all reading cuvettes with an average useful life of about 6 months GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 8 of 78 BASIC INFORMATION 1 9 ELECTRONIC AND MANAGEMENT SYSTEM The management system of GLOBAL 300 is structured through two different CPU the first CPU 1s built into the instrument and manages all the mechanic and robotic functions at a lower level while for the high level management and user interface is provided an external computer which communicates with the internal CPU of the GLOBAL 300 The software running on the external management computer is written to operate under Windows NT environment 1 9 1 ELECTRONIC CONTROL SYSTEM All the electronic control system of GLOBAL 300 is container in a rack system on the right part of the instrument The several functions of the unit are controlled by different boards slotted into a mother board this to facilitate technical servicing of the instrument Therefore are available two boards controlling the motors and the robotic systems one board for the A D conversion and digital signal processing and a board for the control of the different temperatures of the instrument s systems Under the rack mounting of these boards is located the power supply group of the analyser 1 9 2 MANAGEMENT COMPUTER SYSTEM The external computer
28. ded to establish the correct alignment or centring of the mechanical assemblies Set Steps This key activates the function which performs a series of Priming of the diluter A therefore it s used to fill in the hydraulic circuit of sampling system with water when it s Prime empty Au This key recalls the routine to set all the motors of the mechanical assemblies of the instrument to their Home Position Reset Motors GLOBAL 300 USER S MANUAL Rev 1ux 02 05 Page 14 of 78 PRELIMINARY INFORMATION Select the key SET STEPS to access the function needed to set up the instrument the following window will appear Herharical Sep Select Setting i T Ready Tun pon E Da n Press T Ll m Cuvetres Tray AE ww i Setup Pad Up Mov from E CX Ug Mos a a 3 sampie ans Pesmi Detection BamodsaFesde Fensian Descent on M F sample iiem nde Secado vehi El Pesgent LE L Bmwbestk W m gt Sel naci Check num Tem Volume In this menu on the upper central part of the window there is the Cuvettes Tray Set up function which allows the correct centring of the cuvette respect to the light beam coming from the fiberoptic Type in the text box labelled Cuvettes Tray Set up the number of steps needed to achieve the higher reading level in the graph above 1 e type in 1 Hechanical Se bun Fara cuvattes Tray i1 piu setup Res Up Mav fram 9 ZH Se
29. e 21 of 78 OPERATING ROUTINE If he clicks on NO he will return to the initial stage 1f he clicks on YES all the patients are deleted and therefore the counter is reset to 1 The operations described so far can be schematised by the following flow chart Patients in memory Save in Archive YES Keep Unfinished D Delete No YES Enter Patients Once the patients in memory have been deleted and the patients counter reset to 1 the following mask will appear Patient WO 1 STAT m Control C Car pl d NENEAEREBEAEDENEDE XE NER wz cu cx cox mm oor arr var oo wr wo av Casa cx von rer cx ca m6 mx me n iea aca GLU CHE PCR aso ot NA J f 34 gt e k ag 4 Lara reala Plant Prestre EI E TE Cancel Pabardr Cam Urd d Ic he Pan Ei On the upper part of the mask we can find the progressive counter of patients entered the text box for the ID of the patient and the text box for the patients data such as name family name and so on GLOBAL 300 USER S MANUAL Rev 1ux 02 05 Page 22 of 78 OPERATING ROUTINE On the central part of the mask there is a grid with all the tests available which can be selected for each patient while the strip with the numbers above is indicating the eventual profiles grouped tests which can be selected for each patient On the right upper part the operator can select which kind of patient is entered the default is standard patient the
30. e walls of the rotor itself GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 7 of 78 BASIC INFORMATION 1 4 SAMPLING SYSTEM The sampling system of GLOBAL 300 is a SIP amp DIP system which uses only one probe to pipette and delivery the reagents and the samples The system is composed by a diluter module which uses a syringe pump of 10 ml a 3 ways electro valve and a serpentine for pre heating of refrigerated reagent The sampling sequence it s really simple the system aspirates the volume of reagent required then the volume of sample as specified in the method and therefore 1t delivers both volumes into the available reading cuvette Mixing is obtained by means of a subsequent aspiration and delivery of the reaction mixture previously delivered in the reading cuvette In case of methods that use two reagents the second reagent 1s added into the reading cuvette at the following cycle The reagent s pre heating system it s necessary as the reagents are kept at low temperature into the reagents carousel this to reduce the degradation of reagent which occurs at room temperature 1 5 REAGENTS CAROUSEL The reagents carousel of GLOBAL 300 provides 30 positions which can be used for single and double reagent containers this to have always available 30 reagents on line either if mono or 2 components reagents are used The reagents carousel is cooled at a temperature which is about 8 C lower than operating environment s temperature this in po
31. ed shall be performed Therefore the mask of the last patient will appear Patient No E ETAT r OFF Line a NN Paini r Coral 3 er E Vira Control fata a aer c os o se ar ork uot ver cx ca me m sr x Jroa aca er cuv cue por ase TT I II A LL LLL Lol LI 1 1 1 J L 1 jJ L1 1 41 1 0 1 2 41 1 L 41 41 41 1 4 1 1 1 1 4 i Comunica Mei Preia ___ Seded Concello do Patent Em Mj gt j ei k aoje a NOTE It s suggested to not type a patient name and ID on the first patient to be copied this to identify copied patients only basing on the progressive number of the patient GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 52 of 78 SPECIAL FUNCTIONS 4 2 RECEIVE PATIENTS AND TRANSMIT RESULTS The Global 300 instrument can be connected to an external Laboratory Management System therefore it can receive patients accepted by this system and once completed the tests it can resend the patients with the related results to the Management System To access this function the operator shall enter the Patients Menu and then the Enter Patients Menu therefore to access the On Line connection function he shall click on the Communication key At this stage there are the two options Receive Patients and Transmit Results by clicking on the related option key the operator can activate such functions therefore he shall follow the instructions appearing on the screen Note
32. equests contained in the current record either onto the next record or the next records The system requests the operator to specify onto how many records the data shall be copied This key allows the operator to go directly to the record of a determined patient without the need to page continuously through the entered patients by means of the arrow keys This key allows the operator to escape from this function and to return to the Main Menu In case there are some patients already entered in memory in the text box labelled Patient No will appear a number other than 1 as this is a progressive counter of the patients stored in memory When the operator wants to start over a new routine it could be necessary to delete all the existing patients whether these have been processed or not By clicking on the key Cancel Patients the system begins the operations needed to perform such an action on the screen it appears the following message box TE TS Patient No ID amp Patent Control sr Datei i ss ee e a oo relua Z EE E Sor Er ai cos saw cue PER A A AI A 1 1 IL I J PL Lo JI A L Lr r II Y 1 N gt k MM M Loara raza Fiant Praire ETE Cancel Palarii Cam Urd d Go by Pan The message informs the operator that the patients currently in memory are going to be deleted therefore it s requested if these patients and all the related results shall be stored into a permanent file in the historic
33. er Windows NTO environment Inkjet External Printer 80 columns SVGA Colour Display 17 Bi Directional On Line interface RS 232C Indication on Display for the samples Load List Diagnostic System for technical service Help On Line function Environmental Temperature 15 to 32 C Relative Humidity Max 70 at 32 C Volt 115 230 AC x 6 Frequency 50 60 Hz Power 300 VA 123 L x 83 D x 68 H cm 67 Kg ISE module Na K Cl or Na K or Na K Li Stand Floor Cabinet Barcode Reader Rev lux 02 05 Page 11 of 78 PRELIMINARY INFORMATION 2 PRELIMINAR Y INFORMATION The GLOBAL 300 management software allows an easy and intuitive use of all the functions available for the user this to reduce the learning time and therefore to begin almost immediately to work with the analyser Every screen offers different options which can be selected directly with the mouse and therefore with a left click or by using a combination of keyboards keys corresponding to the function desired This section of the manual describes the preliminary information that s necessary to know before to operate the instrument 2 1 REAGENTS PREPARATION Prepare the reagents calibrators and controls required to run the analytical routine Some reagents calibrators and controls require a certain time of stabilization at room temperature to have complete dissolution of powders or before they can be used For the preparation of each reagent calibrat
34. ere the operator can define whether the reagent blank absorbance R Blank Corr must be used to correct the reaction s absorbance only in case a theoretical factor 1s used instead of the calibration using a standard Here the operator can type in a theoretical factor to be used instead of a Factor 1cm calibration to calculate results from the raw absorbance The factor which must be type in here is the factor for 1cm optical path GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 70 of 78 React Mode Reading Time 12 252 Incubat Time 60 300 R2 Add Time 12 204 METHODS PROGRAMMING Here 1s the fourth parameters window bere A Codes dc Method Description Trav pos Control 1 Control 1 Hin Control 1 Max i1 TYT a3H Val Val 1 30 50 control z Control 2 Min Control Max l1 Y DeH Ya Val 1 130 190 Control 3 Min Control 3 Maz Ya val Control 3 Min Control 4 Max Wa Val lt j 4 en S10 v ra Fea Prova Pra pn Parameter Dems Ew And here are the parameters of the fourth window with the related explanations of course the Code Method Description and Tray are common for all the windows Control 1 12Y O N Enables disables the reading of Control 1 during calibration Control 1 Min Val Lower value of reference values of Control 1 Control 1 Max Val Upper value of reference values of Control 1 Control 2 1 Y OzN Enables disables the reading of Control 2 duri
35. everal repetitions of a test it s necessary to enter the Patients Menu and therefore the Patients List function Fabenk L st Pat Cap ID l Test Pat No I nz gt z daraa Whit OGZ1 2 002 Andrew Red OOS 3 003 Luis Black The operator then selects the patient and the test whose different results obtained shall be displayed therefore he shall click on the Details key Paent Let G ER HR ox Dp 0000 0 0000 O 0000 0 0000 p D 0000 0 0000 GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 44 of 78 OPERATING ROUTINE There is also the possibility to have an automatic repetition if the result obtained in case this is above the linearity limit programmed in the methods parameters To activate such an option is necessary to enter into the Service Menu and then into the Set Steps Menu here the operator shall click on the option button Automatic Repetition on the lower part of the screen Ppr hoire Sep Op Mow from sample Descent on sample 3 CE Up Hor Cuvettes Tray FR aa set up Amar O a Aerar t Reagans Deci Bercoda Fader Acebo e o G Dinni dme Pionai Vann Ch Darpa CE Reagents LE Note the automatic repetition of test obtained by the automatic repetition option is always performed with dilution this because the repetition is assumed to be performed when the result is higher than the linearity limit established in method and therefore the repetitio
36. fc restinins CLUCOSTO n 1354 froLESTER Eiii2 TFEIGLYTER 61578 NOPTSALT R 1282 Fn a em Mn BColesceraloa HOL Now the operator in case has decided to enter all volumes manually shall repeat the operation above indicated for each test whose reagent s volume is not enough GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 35 of 78 OPERATING ROUTINE Once completed such operation the operator can start the routine by clicking on the Calibration Patients key on the screen appears the usual message box with the final recommendations before starting operations Rl Fos Vial Vol AZOTEMIA 2006 Crestininm GOT OFI ALT E 1282 Foot Alcalina CGT BR 1246 Inil ror F DL Diretta PAL UDICO milsmi CPE EAC LDH P Cloro pEmloio AAA FOSFORO IT protalce Colesternlo HDL R3 Pos Vial Vol Factor Nr i verfy 1 Master Conana ts ful T Alb contara erg 3 Samples Sid Cablbratoru Cor rolo sam or Trang Ea n i T gt cx od Ww B x Deus ue Este ra Uken OD Js Tt Follow the indications and perform all the checks required by the message box then click on OK the system will start operation and the routine mask will appear The Global 300 is equipped with a safety system which avoids the start of the analyser in case the main cover is open in such a warning message Chart Ares ITEST TRIGLTCER B 1378 GPT ALT B 1252 Fnef ALcalira
37. g on the Continue key As it s possible to see on the following mask this key which normally is deactivated whenever one of the functions previously mentioned is performed and the operator returns to the routine mask it becomes active and therefore to restart the routine the operator shall click on it ezo OK waste ox TY tempo Rinanente fis Test coL pu mero Rea from 25 To 45 GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 39 of 78 OPERATING ROUTINE Moreover during the routine the operator can enter new patients or verify the methods in the memory but not modify them Note During the routine the instrument informs the operator with an acoustic and visual signal whenever the water reservoir is getting empty or in case one or more reagents are not enough to perform the tests in such a case it appears also the indication of what reagents are over or not enough and the sampling system halts automatically the sampling for the tests whose reagents are over Once corrected the problem the operator shall click on Continue key to restart the routine If the operator has got the need to enter new patients while the system 1s working he shall simply click on the Patients key to access the Patients Menu therefore click again on the Reg Patients key as previously described Patient Wo 7 I STAT I CFFLine ID Pater UEM D 7 r Controla Patient Dat Luis BLACK r Canmral 4 B gt k k tj i
38. gent for this test GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 68 of 78 METHODS PROGRAMMING Here 1s the second parameters window Sample Vol Water Vol samp Wash 2 1007 r d 300 1 31 Cm Li MH of Beag 1 2 STD Pos 1 8 MultisTD 1 Y D 8N Beag 1 Vol Beag 1 Fos Vial R1 A B C 330 1 60 200 8 Reag 2 Vol Reag 2 FPos Vial R2 A B C STD Conc 1 a 3 E s E e E Vues ST Views Haag Fra vicun Sj Prat Fradara Faarene Oslak Es And here are the parameters of the second window with the related explanations of course the Code Method Description and Tray are common for all the windows Sample Volume 2 100 Type in here the sample s volume Water Volume 0 300 Type here the eventual volume of water which the user wants to add to the reaction mixture Samp Wash 1 3 Here the operator defines the number of washes which shall be E performed by the sampling system after having sampled this test N of Reag 1 2 Here is defined the number of reagents which are used by the test STD Pos 1 8 Here the operator defines the position of the standard which shall be used to calibrate the test MultiSTD 1 Y 020 Here he defines 1f the standard used is common to other tests Reag 1 Vol 2 350 Type in here the volume of reagent 1 Reag 1 Pos 1 60 Type in here the position of the reagent 1 Type in here the type of vial to be used Vial A is the sta
39. he printout of the Patients List of the Work lists of the patents reports and of the plain results for each test executed GLOBAL 300 USER S MANUAL Rev 1ux 02 05 Page 47 of 78 OPERATING ROUTINE The following function keys are available on the lower part of the mask Print Patient List This key performs the printout of the list of all the patients in memory This key accesses the function for the reports printout with the related options of search of the patient by number ID or name Print Results Print Selected This key performs the printout of the work lists for the tests which have been previously noe selected in the upper test grid Print Today s This key performs the printout of work lists for all the tests which have been run during fea the routine of the day A Test Print Selecte This key performs the printout of all the results for the tests selected in the test grid TEST Print This key performs the printout of all the results for all the tests Hep By clicking on each one of these keys the corresponding printout is performed Note in order to have the printout function operating correctly it s necessary to have a printer correctly installed either real or virtual as file printer under the operating system used p By clicking on Print Patients List key it appears the following selection mask Prist Pasti List By Patient Number In such a mask the operator can select from which number
40. he tests required it appears the following symbol beside the volume present GLUCO OSTO B 1254 The symbol less than means that the reagent s volume present in the container is not enough to perform all the tests programmed according to the patients entered The system performs a calculation basing on the volume required for each one of the tests to be performed according to the volume of reagent programmed in the method and basing on the volume of reagent remaining in the reagent container and which cannot be aspirated by the sampling system dead volume This minimum volume calculated is updated continuously according to new patients eventually entered GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 34 of 78 OPERATING ROUTINE To modify the volume of reagent present in the container the operator shall select with the mouse the desired test therefore he shall click on the Enter Volume key 1t appears the following mask EL A a m a m x E m PUR gwial Vol Rz Po NE Cremrinirn a 30 Bi 08 COLESTER A1112 TPICLTCEP Bi1275 FI magari Yoma 1 50 mr T proteine Colmmtarplm HOL Type in the box the volume of reagent which is present in the container then click on OK to confirm In the Vol Column beside the test code the volume expressed in ml will change according to the volume which the operator typed in the box Shart UT Rl Pos Vial vol Bi Poz Vial Vol Factor HE Test
41. ich can be analysed during the analytical routine for verification All the results related to the control sera are stored in memory and are used to perform a statistical calculation of the standard deviation and of the coefficient of variation for an In Assay control and also in relation to the target values of each control serum GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 56 of 78 SPECIAL FUNCTIONS To access the statistical calculation the operator shall first select the test whose data have to be verified Quality Control az Gre ar cox vsu cor fam ra coro ser non wr cmo one rer ccs cas wes ms mes x CA Cm cu cur por aso junio na TT rTTTTTTTT Type in the initial date from which it s necessary to perform the statistical calculation of control sera values then click on OK it appears the mask with the request of the final date of the period related to the calculation to be performed type in the date and click again on OK This way 1s defined a time range for which will be performed the statistical calculation of the values of control sera GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 57 of 78 SPECIAL FUNCTIONS At this stage it will appear the mask related to the statistical calculation of the SD and CV for the values of the control sera lo Of Data 3 Mean 29 33 By clicking time by time on the keys related to the different control serum or control sera whose values are to
42. in all the desired values by clicking on OK or by pressing the Enter key after each value for confirmation the operator shall click on the Cancel key to close the entering mask and perform the statistical calculation o of Data 9 Mean 15 67 SD 0 71 CV amp 4 51 a w u Fid Dose Vg ue Delle cal Ente Vies Eal To escape from this function click on the Exit key GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 59 of 78 SPECIAL FUNCTIONS 4 7 ARCHIVES There are two types of archive available on the instrument s software the archive for patients and related results and the archive for the methods The archive for the patients is used to have a definitive long terms storage area where the patients which have been already processed and which therefore have the related results can be moved from the temporary area which is used to perform the daily routine Basing on the following diagram it s easier to understand the architecture used in the program INPUT PATIENTS amp TESTS TEMPORARY TESTS MEMORY EN PROCESSING RESULTS OBTAINED ARCHIVE FOR PROCESSED PATIENTS SAVE PATIENTS YES DELETE TEMP MEMORY RETRIEVE PATIENTS ON DISPLAY PRINTER There are two different areas where the patients are memorized the first one is a temporary sequential area which is used to enter the patients details and the related tests therefore during the processing of the patients here are written
43. is is Code composed by three characters but it can also be composed by only two characters This is the long name for the test Le for GLU it shall be Glucose There is the possibility to assign at the stage of programming the methods the reagents tray number which shall contain a group of reagents Therefore the operator will be able to define a tray for the clinical chemistry another tray for esoteric tests and so on To change the composition of a tray it s necessary to modify the number of tray for the reagent which is necessary to move to another tray Units Here the operator can type the unit to express the results I e for kinetic tests the units can be u Kat L or IU L This is the result value above which the response of the chemistry is not any longer linear and therefore there is not the linear correspondence between the increment of absorbance and the increment of concentration If some tests give results above this value these tests shall be repeated with dilution This 1s the lower limit for the reference values normal values This is the upper limit for the reference values normal values This is the value of absorbance of the reagent blank only reagent above which the reagent cannot be considered working correctly This Min Reag Blank OD value is normally pre programmed for BPC reagents otherwise to obtain such a value for different reagents it s suggested to contact the reagent s manufacturer This is the value
44. it key to return to the routine mask GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 37 of 78 OPERATING ROUTINE The operator can moreover add some reagent whenever during the operative routine the system warns him that a reagent is insufficient to run the tests To add the reagent it s necessary to click on the Add Reagent key appears the following mask In the same way on the mask it s indicated that volumes of reagents which are insufficient to perform all the tests appear in red colour and are also displayed in the left column To add the reagent click on the Add Reagent key a mask will appear on the screen oa Pi rer Bonsen Type in the name of the test whose reagent must be added and click on OK a second mask appears and here the operator shall type in the volume of reagent added then click again on OK to confirm the volume and close the mask To return to the routine mask click on Exit GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 38 of 78 OPERATING ROUTINE A further option 1s to stop the routine after the completion of the tests of a determined patient This function is activated by clicking on the STOP key a small mask is displayed and here the operator shall type in the number of the patient at which the routine shall stop Therefore click on OK to close the mask and return to the routine mask Note every time one of the functions mentioned is activated it s necessary to restart the routine by clickin
45. l Rate reactions 2 points kinetic 5 models for non linear calculation Automatic recalculation of curve from raw data Bi chromatic reactions Differential reactions with sample blank 70 positions for samples in secondary cup or 40 positions for primary tubes 10 Positions for STAT samples 30 positions for mono reagents 55 ml or bi reagents 13 ml 40 ml with Barcode Reader possibility 60 positions for single liquid reagents without Barcode Reader possibility Reagents cooling system User definable Calibration Interval Linear and Non Linear Calibration up to 6 points 50 plastic optical cuvettes path 0 6 mm Automatic 5 steps washing station Temperature controlled at 37 C 0 1 C by means of liquid circulation Interference Filters Photometer with available wavelengths from 340 to 700 nm 340 380 405 450 505 546 570 620 700 Bandwidth 2 nm on 340 e 380 filters and 10 nm on other filters Absorbance s linearity from 0 0005 Abs to 2 5000 Abs Max 300 tests hour Rev Lux 02 05 Page 10 of 78 Sampling System Peripherals User Interface Operating Environment Power Dimensions and weight Options GLOBAL 300 USER S MANUAL BASIC INFORMATION SIP amp DIP sampling system with capacitive level detector Pre Heating serpentine for reagents Accuracy in delivery 1 for steps of 1 ul External Computer for data management with software running und
46. ld with a red background are considered indispensable parameters This means that if such parameters are not defined by Important in the windows of definition for the parameters of the test the the operator it will not be possible to store the test GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 72 of 78 ORDINARY MAINTENANCE 6 ORDINARY MAINTENANCE In this section are described some operations of ordinary maintenance which are to be performed by the end user to have the instrument always in good operating conditions and to achieve the best performance during the analytical routine Moreover in this section is provided a list of the parts which are subject to wear and which therefore it s necessary to replace periodically with the indication of the replacement interval for each one of such parts 6 1 WASHING FUNCTIONS By clicking on the Washing key on the Main Menu it appears the window related to the washing functions for the reading cuvettes Washing Position Ipo 1 30 30 Position Extra 1 30 p Um ia if o gt e a 49 Fakari hd lo Eira Ex The default function is the washing of the reading cuvette with the apposite BPC washing solutions the IpoCleaning and the ExtraCleaning solutions which shall be poured into two 60 ml reagent containers dedicated to this purpose and which shall therefore positioned respectively in the positions on the reagents tray indicated on the screen These positi
47. lume Tpl 150 1 pilluent Position 1 30 Two different types of predilution are available the simple predilution and the scalar predilution the default type is the simple predilution The operator shall select the type of predilution to be used therefore in case of the simple predilution he shall type in the apposite text boxes the following information number of samples to predilute volume of sample and volume of diluent to be used and then the position of the reagents tray where 1s located the container for the diluent Once defined such parameters the operator shall click on the Execute Predilutions key 1t will appear the following mask with the last instructions Simple Predilution No of Samples 11 10 Sample Volume pl L t Eu elg orapieec e pur in poche b L Sure cae ae poc n poor 10 NH Hle Eingeen peat Diluent Le x GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 63 of 78 SPECIAL FUNCTIONS After having positioned the samples and the empty cups in the positions indicated on the screen the operator shall click on OK to start the predilution function In case of simple predilution the operator can perform the predilution of more samples max 10 samples while in case he wants to perform the scalar predilution the parameters are fixed and he cannot change them except the position of the diluent scalar Predilution No of Eamplas 1 10 1 Sample Volume Ipl Diluen
48. managing the GLOBAL 300 analyser can be whatever computer with at least 128 MB RAM and a minimum 20 Gb hard disk It s also necessary a CPU supporting Windows NT operating system as the management software is developed to run under Windows environment To this computer will be connected also the Input Output peripherals such as keyboard mouse Display and Printer moreover it s essential to have at least one RS 232C serial port two RS 232C serial ports are recommended in case it s necessary the on line connection with a host computer The external printer is important because this instrument like other instruments of the same class 1s not provided with an internal printer 1 9 3 RS 232 Moreover is enabled the on line bi directional data transmission through an RS 232C serial port to be able to interface the instrument with an external host computer The LIS 3 batch protocol can be used GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 9 of 78 BASIC INFORMATION 1 10 TECHNICAL SPECIFICATIONS Principle of Operation Reading Mode STAT Function Type of Analysis Samples Tray Reagents Carousel Calibration Reading Carousel Optical System Throughput GLOBAL 300 USER S MANUAL Random Access Absorbance Possibility of entering samples at any moment during the routine End Point with continuous monitoring Reagent Blank absorbance control Kinetic reactions Linear Regression Sample Blank absorbance control Initia
49. n 1t can also be a STAT sample an Off line sample or a control These attributes affect the priority of execution of a sample The Off Line sample is to be selected whenever the tests required for the patient are not to be performed on the Global 300 but must be performed on another instrument Therefore it will be possible once obtained the results from another unit to enter these results manually for the patient Off Line This could be useful in case we want to collate on the biochemistry report also the results obtained for ELISA tests or ESR or others The operator at this stage positions the mouse pointer on the field ID of the patient and types in the text boxes the patients ID which could be the number assigned by an external laboratory management system and the patient s name and family name By pressing the TAB key the operator can jump from a text box to the next one Once entered the patients data the operator can click directly on the tests codes in the grid to select the tests to be run for each patient Once performed all these operations the aspect of the entering mask should be the following Patient No 1 px C OFF Lina ID 201 f Patcr C Control 3 E Control 4 Patient Cat George White SB gt k ii u 3 E pinna Cad ior H cii Predicate Taci Care i Palito Corli LalnPaknd barcode reader option The positive ID of the sample is performed by comparing the ID stored for the entered patie
50. n requires the dilution of sample GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 45 of 78 OPERATING ROUTINE 3 5 ENTER MANUALLY RESULTS In case the operator has selected some tests of a patient Off Line then once such tests have been performed on the instruments dedicated 1 e ESR or ELISA readers to type the related results into the system in order to have a report which includes such tests he shall select the function Manual Entry Results under the Patients Menu Enter PEER Cierre Ui LP tt Once the operator has clicked on the Manual Entry Results key the following entering mask will be opened Now the operator shall page through the different patients by using the Next and Previous keys then enter the results obtained by typing them into the text boxes beside the test codes Once completed such an operation it s enough to click on Exit to escape such a function GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 46 of 78 OPERATING ROUTINE 3 6 VIEW AND PRINT RESULTS Once completed all the operations of the instrument the operator as got the possibility to perform a printout of the reports or of the simple results by means of the Reports Menu This menu can be recalled from the Patients Menu and can be accessed by clicking on the Reports key The mask related to the Reports Printout Menu and its options appears on the screen CA Um me x ua In this menu it s possible to perform t
51. n routine H20 OF Waste CE Tempo Rinanente Bia Test GL Bera lea from 25 To 45 cm won gt i e o j x 3 Cons eoo x Canta La idd ara pde Ard Fi aan Bort Patents Maroc At this stage while calibration 1s in progress and in case Only Calibration function has been selected it s possible to enter patients by clicking on the Patients key In such a case the Patients Menu will be opened and then the operator can proceed as indicated in the section 3 1 Once the patients required have been entered by clicking on Exit key twice the operator will return to the routine mask above displayed To abort for any reason the routine simply click on the Abort key GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 30 of 78 OPERATING ROUTINE 3 3 START ROUTINE If the operator has chosen to run only the calibration routine as stand alone and not grouped with the analytical routine after having completed the calibration he has got the possibility to run immediately the tests on the entered patients upon having verified the calibration values and the eventual control sera values To start the analytical routine after having entered all the patients from the Main Menu click on Start key In this menu the two graphic representations of the Reagents Tray and of the Samples Tray are displayed with the indication of the reagents and of the samples present on the respective trays Al LALA AU On the samples tray we can see the
52. ndard 60 ml Vial R1 A B C single reagent vial the vial B is the 40 ml container and the vial C is the 13 ml container Reag 2 Vol 2 350 Type in here the volume of reagent 2 Reag 2 Pos 1 60 Type in here the position of the reagent 2 Vial R2 A B C Same as Vial R1 Here 1s defined the concentration for the Standard 1 in case of use of STD 1 Conc l linear chemistry this concentration corresponds to 0 reagent blank Here is defined the concentration for Standard 2 in case of linear STD 2 Conc chemistries this would be the multi parametric calibrator common to other tests Here and in the following positions is defined the concentration of each STD 3 Conc e ed one of the standards needed in case of multi point calibration STD 4 Conc STD 5 Conc STD 6 Conc IN GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 69 of 78 METHODS PROGRAMMING Here is the third parameters window LE aa Ping Putea pi Code Method Description Tray oT n vil React Mode 1 EndPoint 2 Kin 3 I8E 4 In Rate h nDif i Reading Time Incubat Time BR Add Time 12 252 60 300 12 204 Filter 1 Filtar 2 First Reading 340 905 505 546 570 620 380 450 700 Time 60 192 340 O ANM Esaurimento Reac Direct l1 Incr Decr 1 R Blank Corr Factor lcm 1 T O N 1768 And here are the parameters of the third window with the related explanations of course the Code Method Des
53. ne connection is not present or cannot be implemented In the same way to activate the printout of results for some tests the operator should select the tests whose results printout are needed in the tests grid therefore he shall click on X Test Print Selected key az cxx B con tn cor er rau Gor ere o Cana ces mom rer ca ca wc mm re x ica mr exo cm por aso mr sa Tr a e TEST Fint Al 3j Esi Otherwise to perform the printout of the results for al the tests of the patients present in memory the operator shall click on the X Test Print All key without any previous selection of the tests To escape from this menu click on the Exit key to return to Patients Menu and therefore click again on Exit to return to the Main Menu GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 51 of 78 SPECIAL FUNCTIONS 4 SPECIAL FUNCTIONS 4 1 COPY ONE PATIENT S DETAILS ON FOLLOWING PATIENTS This function present under the Enter Patient Menu allows the user to establish a series of tests for a patient and then to copy such details onto the following patients When in Enter Patients Menu and having selected the tests required the operator shall click on the Copy Until key Heg P etisi a Patient Ho 3i z E OFF Lia ID E Pati EE a3 CANET IRL 9 M Then the operator shall type the number of the patient until which the copy of the data enter
54. ng calibration Control 2 Min Val Lower value of reference values of Control 2 Upper value of reference values of Control 2 Lower value of reference values of Control 3 GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 71 of 78 METHODS PROGRAMMING Here is the fifth parameters window View JM elr Heatha d Code nep per i HMM Vol Diluente MEM Pos Diluente 100 3 1 301 Model 1 61 Max Variance 1 10D0 And here are the parameters of the fifth window with the related explanations of course the Code Method Description and Tray are common for all the windows Here is defined the Volume of Diluent to be used in case of pre dilutions or in case of immunoturbidimetric chemistries Here is defined the position of the Diluent In case of immunoturbidimetric assays this position can be common to other tests Here is selected the algorhythm which shall be applied to calculate the Model 1 6 calibration curve Note that for linear chemistries such as clinical chemistry tests the model to be used is 6 while all the other models 1 to 5 are all non linear This variance expressed in percentage of variation is defined by the user to establish within which variation can be accepted the result recalculated basing on the calibration curve built during the calibration of a test Max Variance 1 100 Important the test code can be either of one two or max three characters parameters which appear on a fie
55. nt GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 55 of 78 SPECIAL FUNCTIONS 4 6 QUALITY CONTROL The Global 300 has got available four levels of Control Sera which can be programmed by the user and can be used to verify the quality control system of the instrument The Global 300 Quality Control system can be accessed from the Methods Menu by clicking on the QC key the following screen will be displayed Ch sal x Cm Quality Control AA n i ei In the Quality Control system are available different functions which can be recalled by means of the function keys present on the lower part of the mask such functions are the following With this key the operator deletes all the results obtained for all the control sera in the quality control database eS zi Jo Kj fn mj A em e Cancella Valori all the values obtained for the control sera during the calibration and the analytical routines Controlli With this key the operator can access the function to perform a statistical calculation on Ei With this key the operator accesses the window of verification of the optical densities uD Bianco related to the reagent blank values and of the calibration factor obtained This key activates the statistical calculation function for a series of values entered by the user Manuale The control sera which can be analysed on the instrument are C1 and C2 which normally are run during the calibration and C3 and C4 wh
56. nts and the ID which is read by the barcode reader on the samples tray Note The ID of the patient is important whenever the instrument is provided with the GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 23 of 78 OPERATING ROUTINE A different way to select the desired tests 1s by typing the codes directly using the keyboard This is it will appear a text box A Test Selec ban the operator will be therefore able to type the test codes directly and confirm the code entered by pressing the Enter key on the keyboard Once entered the last test code the operator shall press Esc to close the text box By clicking on Next key all the patient s data and requests are stored and the counter moves to the next available free position at this stage proceed to enter again the data required for this new patient Fatient Ho C ETAT gt OFF Line i C Camral 2 Patient Dat andrew Hed 3 C Conul 4 a ata cor cr e oc m on e am cek ron rer ct ea me en 1 x 16A aca I I I I 3 Pi pad Pre E ala rind k Caro Fsi enis Copa Url Poll Eur The selection of tests for the patient can be performed also by clicking on one of the profile s numbers present above the text codes grid Once entered the last patient s data click on Next and therefore on Exit to return to the Patients Menu GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 24 of 78 OPERATING ROUTINE 3 2 TESTS CALIBRATION On the Global 300 s
57. o recall the tests to be calibrated which have been previously selected by clicking on the Test to Calibrate key or From Enter Pat Key it will appear the mask with the selected tests Calibrate SELECT TEST Pe EN oo coc rar ors ons o om cre on rer exs coo mem me e nox Contnu Teth onthe dd Tann Fron Enter Pad Its moreover possible to select for the calibration all the tests which have not been calibrated yet by clicking on the key AII Tests In such a case all the tests which have not been calibrated in any previous routine will appear selected on the tests grid To continue the operator shall click on the Continue key Rl Pos Vial Vol ER Pos Vial Vol Factor Nr Teat AZOTENTA 02008 Lremtininm GLUCOSIO R 1254 ICoLESTER Fiii TRIGLTCER RI37B AAA AN J Water contineri fl e ae con rr nota 2 55nples Sho Colbestors B Con bob are n Trew On the screen appears a message box with all the last recommendations about the controls and checks needed before starting the calibration routine Therefore verify the presence of water in the reservoir in the right front part of the instrument and if the waste container beside the water reservoir is empty GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 29 of 78 OPERATING ROUTINE After having checked all the mentioned recommendations the operator shall click on OK to confirm and the system will therefore start the calibratio
58. o the chapter Theoretical Principle for more details about this matter 1 5 PHOTOMETER ASSEMBLY The photometer assembly used in the GLOBAL 300 instrument is composed by a quartz lamp with stabilized power which provides a spectral emission in the UV IR and Visible spectra regions A filters wheel with a set of 9 interference filters which rotates continuously supplies a series of monochrome light beams which through a fiberoptic cable are transmitted to the reading carousel where 50 plastic cuvettes are installed in such cuvettes occur the chemical reactions The light beams passing through the fiberoptic cable are transmitted through the reading cuvettes and therefore are detected by a photodiode which converts the light signal into an electric analogical signal This signal is then amplified to be after converted into a digital form for further processing On the filters wheel are installed the following standard interference filters 340 nm 380 nm 405 nm 450 nm 505 nm 546 nm 570 nm 620 nm 700 nm On each reading cuvette is performed the scanning with all the available wavelengths thus allowing the multi chromatic reading The reading cuvettes are kept at a temperature of 37 C by means of a system using a thermo regulating liquid which circulates into the external chamber of the reading carousel therefore the reading cuvettes are not immersed into a liquid but are warmed by the air circulating in the space existing between th
59. oftware the tests calibration function requires that tests to be calibrated must be selected and entered before such as for the patients This because the operative flexibility of the instrument allows the operator to start an analytical routine for the tests already calibrated and in the meanwhile to perform the calibration of the tests still to be calibrated giving therefore the possibility to program completely the analyzer s work and then leave the operator to perform other tasks a perfect sample of Walk Away operation To select and enter the tests to be calibrated it s necessary to access the Methods Menu and then the Calibration function To access the Methods Menu simply click on the related key under the Main Menu the following window appears At this stage simply click on the Calibration key the Tests Selection Mask appears SELECT TEST Eo li e Ll e AMI CPR DH FEF cL CA MG PH TP E IGA RE a p NOS A a ee a E T A GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 25 of 78 OPERATING ROUTINE Now the operator can select the tests individually by clicking on each test code with the mouse An alternative way to select the tests is to click on the key From Enter Pat in this case the system will automatically select the tests which have been requested for the patients currently in memory Therefore by clicking on such a key the following mask will be displayed Calibration an
60. ogramming function by clicking on the Methods key the following mask appears on the screen m Then the operator shall click again on the Methods key on the lower part of the screen the tests grid will appear on the screen in order to allow the operator to select the test which shall be modified Tests in Memory COL TRI GOT GPT FAL GGT BIT BDD FEF CL ca MG E I GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 65 of 78 METHODS PROGRAMMING On the lower part of this mask there are some additional function keys which can be selected by the user E This key accesses the Archive functions for the Methods Archia This key allows the operator to define a completely new test Hew Test a This key allows the operator to view the parameters of an existing test and eventually to Modiuvien Ter modify them hd n This key allows the operator to rearrange the positions of all the tests on the test grid Arange Tes la This key allows the operator to delete a test whenever it s necessary Date kialbari Pint Sekeried This key allows the operator to select some tests and therefore to print the parameters for ls each selected test ix This key performs the printout of the parameters for all the tests in memory Print All Taste The operator can therefore select a test code in the test grid by clicking on it Sets Hg Es L E 1 by Hora Tact boc halmen Tai Dakota Alto Fari ii Tanz
61. on the Service key therefore once in this menu click on Prime key 1t will be displayed a mask requesting the operator to type in the number of times the priming cycle shall be executed EE Washing System Reaction Tray Reset Washing Arm o Reset Cuvettea Tray Samples Tray ME x Reset Barco APRA cal Movemen M Nu Ed Arnis Peset sampi Fass rontal Moven e Photomete ee rn et Motor OrF 3 Reset Reagents Tray p T Frobe washi Diluter Reset niluter A Waste Probe wash Pump F E Probe Washing Yalves of sf EE Valve OFF a Y 4 of Larges Aral Hoima Exi The operator shall type in the number of priming cycles desired and therefore shall click on the OK key to start the priming operations GLOBAL 300 USER S MANUAL Rev 1ux 02 05 Page 74 of 78 ORDINARY MAINTENANCE 6 3 ORDINARY MAINTENANCE REPLACEMENT CHART Here is the table related to the maintenance operations which must be performed periodically on the instrument basing on the frequency of replacement of the parts subject to wear Expansion Reservoir On Instrument s Alert Photometer s Lamp 2000 Hours Reagents Tray 14 Days Reading Cuvettes 3 Months Barcode Reader 3 Months Piston Syringe 6 Months Bellows Pump 6 Months Bellows Pump 12 Months Cuvettes Washing System Tubes 12 Months Cuvettes Drying Tip 12 Months Sampling Probe 12 Months To fill in use the cleaning solution code BPC C 40
62. ons can be defined by the operator according to the availability of places on the reagents tray To start the washing with such solutions the operator shall click on the Ipo Extra key the confirmation mask will appear on the screen and therefore by clicking on the OK key the operator shall start the washing cycle A Such washing with IpoCleaning and ExtraCleaning must be performed once a week to ensure a proper performance of the instrument GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 73 of 78 ORDINARY MAINTENANCE In the same window the operator can recall the standard washing function which executes a washing cycle of the reading cuvettes with plain distilled water This function is activated by clicking on the HO key and starts immediately without any confirmation mask To escape from this function click on the Exit key while no operation is in progress otherwise the system will not escape from the window 6 2 PRIMING DILUTER S SYRINGE This function performs a series of washing of the syringe of the diluter module The washes related to this function are normally to be performed whenever the instrument has been not in use for a certain period of time and therefore the hydraulic circuit of the sampling system is completely empty of water Moreover this function can be used to verify the correct holding of the piston in case of replacement basing on ordinary scheduled maintenance To activate this function click
63. or and control follow the directions included in the respective packages 2 2 SWITCHING ON THE INSTRUMENT To switch on the GLOBAL 300 analyser follow this start up sequence first turn on the external computer and wait for the management software to be loaded and running therefore turn on the instrument by acting on the main switch located on the right side of it Wait until the GLOBAL 300 analyser performs a reset cycle then on the display will appear the confirmation of the established communication between the external computer and the micro controller of GLOBAL 300 s interface at this stage the settings stored onto the interface micro controller of the instrument are transmitted to the computer therefore the mask of the main menu will be displayed on the screen 2 3 MAIN MENU AND SUB MENUES In the main menu the user can have a general overlook of the status of the instrument including a graphic representation of the reagents and samples trays On the lower part of the screen there are the different command keys which are used to enter the other menus and functions of the instrument The following function keys are available This key launches the analytical routine With this function it s also accessed the La calibration of the methods which can be performed as stand alone or together with the Start analytical routine This key launches the ancillary function used to predilute samples 1 e urine CSF or Predilutions e i
64. r 3 sampla FARER Fa perde Dalecho Barcode Arsis Hrid Heads Fle petitor Descent on AE e y sample domme Anbo Sorabas CE anoles Ck Pia merda Ck GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 15 of 78 PRELIMINARY INFORMATION the reading is performed by clicking on the Read key therefore the graph will change accordingly and a red line on the upper portion of the graph will appear indicating the transmittance level of the light beam across the reading cuvette Select Setting E Ready a 4 a Paal P Ld Cuvettas Tray J IE n Setup Up Moy from 0 C lip Hus rs O e sample Mor E Delenn Barcode Fasder Faceti on Descent on CK Dian Hai EX LE a sample dimai iore Subse ome in horses Ck Samples Li Fis agenda Li This level must be as higher as possible indicating that the light beam is passing exactly across the centre of the cuvette At this stage click on Exit key therefore escape from Service Menu by clicking again on Exit key and when in ain Menu click on the key CK Cuvettes it will appear the window related to this function Ho Data in Memory GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 16 of 78 PRELIMINARY INFORMATION when in this window click on the Execute key to perform the check on all the reading cuvettes this operation performs a check of transmittance on all the cuvettes establishing the reading baseline equal
65. rator to modify for each test to be calibrated the related concentration of the calibrator avoiding the need to modify this parameter in the method s programming This key allows the operator to modify for each test to be calibrated the related calibration factor either theoretical or obtained from a previous calibration This key allows the cancellation of all selection made before the calibration Therefore by clicking on this key in case some tests have been previously selected to be calibrated such a selection will be cancelled At this stage it s necessary to click on Run Calibration key to store the tests which have to be calibrated the system then returns to the Methods Menu therefore click on the Exit key to return to the Main Menu In such a menu click on the Start key the following mask appears Sant dina leer Bl Fo3 Vial Hz Pos Vial Vol Factor Nt LEGTERIA 22006 PE 63 Creat Lil iesi rj Cica ca fa fa TES Bil Direrca Ko TRIC T proteins Colestecolo HPL C A c T c c E C C c T 4 x E q bi fi Fal g IC n e M Caram sar Onde C sibratnon Fisa rar Enter Volume Deer Tet euer eya Hermt Carcel The operator has got the possibility to perform the sole calibration routine for the selected tests or the calibration routine immediately followed by the analytical routine this in order to optimize the job To run only the calibration routine click on the Only Calibration ke
66. rn If you have discarded the packing box try to pack the instrument completely using shock absorbing materials BPC BioSed is not responsible for malfunction or damage due to incomplete packaging or caused during transport About damage BPC BioSed is not responsible for any direct damage or indirect damage caused by using the GLOBAL 300 Page 3 of 78 TABLE OF CONTENTS TABLE OF CONTENTS tk BASIC INFORMATION ovina 6 LI INFRODUGTION oi st o e le cat ee 6 LP MOD UDE ea ea eat eo a pta cod dl os eta lo da no data LEE atado 7 ES PHOPDPONILBTBEIRSAXSSENDBL ae 7 L SAMPLING SYSTEM e endoso 8 1 5 REAGENTS CAROUSEL ennemi 8 LO DILUTERMODULE o a ua ME 8 1 7 SAMPLES TRAY jp 8 1 8 READING CUVETTES CAROQUSEL 4 RR 8 1 9 ELECTRONIC AND MANAGEMENT SYSTEM HIceHe 9 1 9 1 ELECTRONIC CONTROL SYSTEM cerent en nne nene tne sene tne tenens ene 9 1 9 2 MANAGEMENT COMPUTER SYSTEM certet nein eee teen testen etes nne 9 KES em M EMI LI UR DE 9 1 10 TECHNICAL SPECIFICATIONS ctn 10 2 PRELIMINARY INFORMATION coincidi 12 2 1 REAGENTS PREPARATION nenea nennen enne 12 2 2 SWITCHING ON THE INSTRUMENT cttm 12 2 3 MAIN MENU AND SUB MENUES mene 12 2 4 INSTRUMENT S INSTALLATION creen 14 SP OPERATING ROUTINE Sida 18 3 ILENTER PATIENTS REOUBS ES iei etn as 18 3 2 TESTS CALIBRATION nenea nea aaa aaa 25 39 5 START ROUTINE I D D i 3 SL ISEPEBAT IBS NT 41 3 5 E
67. s Cro Lone rer ex cae ws me meo x ca me w TOR Laban E EH ont 4 ENS Teas eno Hoin The selected tests will be the ones selected for the patients entered during the previous phase Now the operator shall click on Run Calibration key to display the following mask Calibrakion STD Fosition Craatinina of 7 51 00436 GLUCDOBIO A 1254 i 161 583 COLESTER RLI12 355 0034 TEIGLYCBR Rl37B 474 62023 A A Holy STD 3j T sn Caras Concerta Mob Fact Auman Carcel In the above mask the operator can modify the variables of the calibration such as the concentration of calibrator the calibration factor or 1f he wants he can select to perform the calibration against calibrator or against factor GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 26 of 78 OPERATING ROUTINE The functions available in this mask are the following T Aun Calibration Delete Reztore Delete Reztore Controls Modify STD Concentration Modity Factor Cancel This key activates the calibration for the selected tests This key allows the operator to delete or restore the concentrations of calibrators for the tests to be calibrated allowing therefore the possibility to perform the calibration against a calibrator or against a previously obtained calibration factor This key allows the operator to enable or disable the reading of the control sera to be analysed during the calibration This key allows the ope
68. s and printouts of the instrument By clicking on the Laboratory Heading key the operator accesses the function which allows him to modify the header EPC BioS3ED sel Via Traversa del Grillo Em 0 606 Tel 065073666 Fax 0635073200 Partita Iva 000000000000 x End Here the operator shall type in the lines corresponding to the desired header and therefore once completed this modification click on Exit key to return to Patients Menu GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 54 of 78 SPECIAL FUNCTIONS 4 5 CREATE MODIFY PROFILES This function present under the Methods Menu allows the user to define a series of profiles which will group several tests and will be useful to speed up the Enter Patients operations By clicking the Panels key under Methods Menu the definition mask will appear Panel N 1 XH BETA cos vo cor ort rau cor mi won av mam cox ion rer cu ca me m zr E nca ac me CCC mnt iti TITT 5 p Hasi Fa siana Enl Here the operator can simply click on the test codes which he wants to be grouped under a profile number and therefore once all the desired tests are selected click on the Next key to store the profile or Panel and move to the next available one Clicking on Exit key will escape such a function A Important Before deleting a test from the methods database eliminate it from on profiles to avoid malfunctioning of the instrume
69. serum to be used for immunoturbidimetric tests GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 12 of 78 PRELIMINARY INFORMATION This key accesses the functions related to the data handling of the patients such as Enter Patients amp Requests Print Report Patients Lists and so on This key accesses the functions related to the Methods data handling and to the programming of the different chemistries Under this functions there 1s also the calibration of the programmed methods This key accesses the standard maintenance functions related to the washing of the reading cuvette with the apposite solutions or with plain distilled water This key accesses the function for the baseline reading of the cuvettes therefore the check of all the reading cuvettes with all wavelengths to establish their adequacy for the routine and the baseline for the routine readings CE Luvette This key accesses the functions relate to the diagnostic menu and to the different s electronic and mechanical set up needed for servicing the instrument At the moment the instrument is operative on the display will appear the main menu with the three icons related to the main functions located at the centre of the screen and the scroll menu items located on the left upper part of the screen Use the mouse pointer and its left key to select and confirm the functions desired The following sub menu with the different control and management functions of the
70. sitions from 1 to 22 while the positions from 23 to 30 are designed to be less affected by the cooling system and therefore can be used for the reagents which are usually stable at room temperature and do not need to be refrigerated Moreover is provided the possibility to have an optional Barcode Reader This optional device can read the barcode positioned on the back of the reagent containers to achieve an automatic detection of the reagents positioned into the reagents carousel 1 6 DILUTER MODULE The diluter module of GLOBAL 300 is designed to achieve a precision of 1 ul in delivery thanks to the special design of its threading screw used to drive the movement of the piston The 3 ways electro valve used on this module is a special model appositely conceived for long lasting and efficiency 1 7 SAMPLES TRAY The samples tray of GLOBAL 300 is conceived for a great flexibility of use The positions available allow the user to have up to 70 standard samples plus 10 STAT samples into secondary cups or up to 40 samples in primary tube 10 ml type In case it s available the optional Barcode Reader unit it s possible to have the positive ID of the positions of samples contained in primary tubes only together with related patients data of the samples 1 8 READING CUVETTES CAROUSEL This part of the instrument contains the plastic reading cuvettes that are used for the reactions development and the reading of related absorbencies A liquid cir
71. t Wolume plist lil Diluent Position 1 30 This type of predilution allows the dilution of a sample basing on a geometric trend therefore the dilution ratios will be 1 1 whole sample then 1 2 and then basing on the geometric trend 1 4 1 8 1 16 and 1 32 This type of dilution is used to prepare the calibrators needed to calculate a calibration curve starting from a single calibrator typically for immunoturbidimetric tests In such a case as the operator clicks on Execute Predilution key it appears the following mask scalar Predilution Ho of Samples 1 10 Sample volume ul e Dill N Fees cen Da LS E pore po Ti Diluent z Enmpt ran ara put in position 11 005 Mosen gin gen position 1 To escape from this function and return to the Main Menu click on the Exit key GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 64 of 78 METHODS PROGRAMMING 5 METHODS PROGRAMMING As the Global 300 is an open instrument it s possible to modify the existing pre programmed methods in order to use them for different reagent s brands It s also possible to define new methods and chemistries for different tests The methods programming functions are available for the operator directly from the Main Menu The operator can have access to such functions simply clicking on the Methods key on the lower part of the screen 5 1 MODIFY METHODS To modify an existing method the operator shall simply access the methods pr
72. the results for each test This area has got a limited size therefore whenever a new routine must be performed on a different day it must be cleared to get room for the new patients At this stage the operator is requested to save the patients already processed into a definitive archive This is a different area where the patients are stored definitively in a single file named after the date of the day when the storage operation is performed and whose extension is ARC i e 25 01 05 ARC From this location the data can be retrieved whenever needed GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 60 of 78 SPECIAL FUNCTIONS To access such an archive the operator shall click on the Archive key under the Patients Menu the Archive mask will appear on the screen W02 15 2005 Bre 3 05 2005 are 11 16 2009 Arc 11 19 20904 Are 12 22 2009 Arc Therefore the operator has got several functions which can be accessed by clicking the lower keys and which are related to the data management of the archives To perform any operation it s always necessary to click on one of the files present in the upper left area of the screen therefore the operator has got the possibility to print a list of the patients for the day selected by clicking on Patients List or to print a report for the desired patient by clicking on Print Reports or even to delete an archive file whose backup copy has been created or which 1s not necessary any longer by cli
73. ts entered ao of GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 41 of 78 OPERATING ROUTINE To repeat all the tests for all the patients present in memory which would be the same of repeating the entire routine the operator shall click on Repeat All key The results present beside each one of the test in the right column will be replaced by the RERun indication Hepeats i i A E mE FPat cap ID Ham TEST Faz N 3 ID01 1 001 George white poz 2 002 Andrew Red y I I 1 d hi o 3 Stith Din without Do Otherwise to repeat all the tests of a single patient the operator shall select the patient by clicking on 1t with the mouse and therefore shall click on Repeat Patient key LLL ENT Pat Cap ID a TEST Paz Hal HJULET J 1 SEOrge Write Az RERuti WE Andrew Red GI RERUN 1003 luis Black COL RERUN 9 3 wW hDiden without Dion GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 42 of 78 OPERATING ROUTINE To repeat only the tests selected for a certain patient the operator shall select the patient then he shall select the tests by clicking on the desired tests in the right column at this stage the Selected key which normally is deactivated becomes active and therefore the operator shall click on this key Rae NNNM Pat Cap ID Ham TEST Paz H 2 AZ 43 EPE E E r Hed CHE RERUN azi x 003 Luis Black GL Ab coL 16 TRI 93 T m m y ma HILDE He d
74. two patients which have been entered and on the segment 8 which is normally used for the calibrators and controls the two control sera C1 and C2 present on it In case it s been entered a number of samples higher than the number of positions available on the samples tray the key Change Samples Tray is activated and by clicking on such a key the operator has got the possibility once completed the tests routine for the samples present on the tray to select the eventual additional samples entered and therefore to start a new analytical routine Of course he shall remove the previous samples from the tray and position the new samples on it For instance if the operator has entered 120 patients the samples tray with secondary cups can accept maximum 70 samples therefore we have the following correspondence established From Sample N To Sample N 120 Therefore once the analytical routine for the samples from 1 to 70 1s completed the operator shall remove the samples from 1 to 70 and position on the tray the samples from 71 to 120 in the positions from 1 to 50 then he shall start the new analytical routine GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 31 of 78 OPERATING ROUTINE The option Patients List on Patients Menu it s really useful to verify the correspondence between progressive number of the sample and position on the tray In case it s necessary to have a larger image of the samples tray click on Patients key to displ
75. ualized and eventually imported into the tests grid whenever 1t becomes necessary to the operator To access this Methods Archive the operator shall click on the Archive key under the Methods Menu then the following mask will be displayed on the screen Restoring Saving e c id ES E File Name Fila Name Mat 00001 AEC In this case it s possible to select the drive where the methods are going to be saved and from which the methods are going to be retrieved Also in this mask are available the functions which allow the operator to save or restore the methods into the test grid GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 62 of 78 SPECIAL FUNCTIONS 4 8 PREDILUTIONS It s available an auxiliary function which cannot be directly available during the routine which allows the predilution of samples to be used later for the execution of particular assays which require the use of prediluted and not whole sample Such a function results to be useful whenever it s necessary to perform some tests on urine or fluids other than serum used normally or for some turbidimetric assays on serum which require the use of prediluted and not whole sample To access this auxiliary function the operator shall click on the Predilutions key on the Main Menu the following window related to the predilutions function will be displayed Simple Predilution Mo of Samples 11 101 I Sample volume gpl 154 Diluent Vo
76. whose tests have been performed on a date other than the current one This key accesses all the functions related with the results reporting management This key enters the function with which is possible to define a header for the pe laboratory which will be printed on the test reports This key displays a list of all the patients entered processed by the system This key is necessary to access the Enter Patients amp Requests function Reg Patient E This key allows the user to type manually the results for the tests which have not been Mee performed on the instrument such as the OFF LINE type tests GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 18 of 78 OPERATING ROUTINE This key allows the operator to escape from this function and to return to the Main Menu At the beginning of the routine when the operator accesses such a screen he can select the type of samples tray which shall be used It s possible to operate with secondary cups up to 70 samples or with primary tubes up to 40 samples The selection is performed by clicking on the keys located in the upper right part of the screen cups Every time the user changes the type of samples tray to be used the system i NOTE It s not allowed to use at the same time the primary tubes and the secondary warns the operator to delete the patients previously entered with a different tray To access the function which allows the user to enter the patients and
77. y otherwise click on the Calibration Patients key GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 27 of 78 OPERATING ROUTINE By clicking either on the Only Calibration key or on the Calibration Patients key 1t appears on the screen the following mask preliminary to the routine start EST s Vol A Pos Yial Vol Factor Ne Test JAZOTEMIA C2006 CEesrinina GLD OSID E 1784 COLEBSTER Ri112 TRIGLYCER FLSTS GETALT B 183 regne i 06 2 paote container E empty EE 3 53 ples Shd Calbrstors amp Controle are on Trap IT protsire E Colazececolo HIL By clicking on OK the calibration routine will start eventually followed by the analytical routine according to the function selected As in the mask are normally present all the tests available in the reagents tray the operator may want to perform the calibration only for the tests which he effectively needs to run the routine therefore he should select the tests which are to be calibrated To perform such a selection he must click on the Select Test key it appears the following mask SELECT TEST Az CRE GL COL TRI GOT GPT FAL GGT brT BDD AU AMD CPK LDH FEF CL CA MG PH TP E IGA AGA mr emm rm aso mob gt gt Fh kh a Cor n Texi bo cabane el Tesla Fos Entes Pi Eel GLOBAL 300 USER S MANUAL Rev lux 02 05 Page 28 of 78 OPERATING ROUTINE At this stage it s possible t
78. y means of 50 plastic cuvettes moreover is provided an automatic washing station which grants a large autonomy for number of tests to be performed An external computer performs management of patients GLOBAL 300 Management Software has been conceived to use all the functions of the instrument in a simple and intuitive way keeping at the same time the needed flexibility to meet the different needs of each laboratory of analysis The following parts compose the instrument GLOBAL 300 Diluter Reading sampling Arm Module Carousel Photometer Assembly Washing IN Cooling System b Assembly amp Temperature samples Tray Control 2 Assemblies a E pue ERA Vidic si pyi j A diui GLOBAL 300 USER S MANUAL Rev Lux 02 05 Page 6 of 78 BASIC INFORMATION 1 2 OPTIC MODULE This module is composed by the interference filters photometer a fiberoptic cable the reading carousel and a signal preamplifier The photometer emits light beams of several wavelengths sequentially these light beams are transmitted through a fiberoptic cable to the reading carousel where it s performed the reading of reactions specific absorbencies The light beam attenuated by the passage through the reaction mixture reaches a solid state detector which converts it into an analogical electric signal This signal so obtained will be therefore converted into a digital signal to be opportunely processed Please refer t

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