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        ElePhor 24S USER MANUAL
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1.       InterMlecicall  Diagnostics       ElePhor 24S    AUTOMATIC ELECTROPHORESIS ANALYSER    USER MANUAL    REV  01 2011    ELEPHOR 24S   USER MANUAL    1 0    2 0    3 0    4 0    INDEX    DESCRIPTION OF THE INSTRUMENT  1 1 Standard components   1 2 Technical characteristics   1 3 Host computer requirements   1 4 Installation    TURNING ON  2 1 Instrument preparation  2 2 ELEPHOR 24Smanagement software start up       ELEPHOR 24S       MANAGEMENT SOFTWARE  3 1 Main Panel  3 2 Starting Work  3 3 Patient Lists  3 4 Archive Management    Storage    Search by date    Search by name    Data backup    Restore Data    Deletion  3 5 Display graphs    Delete areas    Insert minimums    Remove minimums    Edit baseline    Calibrate Fraction    Highlight fraction    Set fraction name    Cancel Changes    Print current graph  3 6 Configuration    EXAM parameters    VARIOUS    REAGENTS  3 7 Printout    Print graphs in archive    Print graphs of the day    MAINTENANCE  4 1 Daily maintenance  4 2 Routine maintenance    Page 2 52       Nan  amp  Bye    on    10  10  12  14  16  16  17  18  19  20  21  22  24  24  24  24  25  25  25  25  25  26  26  29  30  31  31  32    33  33  33    5 0    5 1  5 2  5 3    A l  A 2  A 3  A 4    B 1  B 2    QUALITY CONTROL QC  New Control  Modify Control  Delete Control  Exec a QC statistics    REMOTE HOST  Setting Remote Host Info  Start     Selecting data from Remote Host  Sending data to the Remote Host  Send Database Items to Remote Host    VETERINARY SC
2.    Values of samples are shown on the graph in the range of confidence 2s   2 s that is in the range of 2  times the standard deviation    Pressing the button press produces printed copy of the QC for all these villages  regardless of the  currently displayed     Page 39 52    ELEPHOR 24Ssoftware is capable of exchange data with a remote host in order to manage exams  Work list automatically     Exam Misc   Reagents Remote Hast    Remote Hast    Inpu amp Data Path InpubFile Name     NETDIR ACCETTAZIONE    QutpulDatajRath    tim firm     F  TEMP EXPRIMENET NETDIR JE       Pressing the  REMOTE HOST  button you ll be able to indicate where remote host data are located   You must first indicate the name of input file without extension  this file contains the work lists  after  this you can use the browse button           to locate your file folder    The same is for the output file  this file contains the results of exams      Page 40 52    A 2 START     SELECTING DATA FROM REMOTE HOST    In order to select data from a remote host you must     e Press the button  START  from the main screen of program  e Press the button  REMOTE HOST     REMOTE HOST  SIEROPROTEINE         Items Selected   fo  Items Sended   fo    Select Items    Delete Last Selection      Delete All Selections    Print Last Selection      Print all Selections   ltems Sended   ltems To Send   Send Items      Now you ll see all available exams queued and for each exam the work list    Selections are possible into t
3.   ARCHIVE MANAGEMENT   RESTORE    Store   Search by Date Z by Name   Backup PE Delete e Host    estore Type          Entire Backup    C A Year          A Month             Select  RESTORE  from the  ARCHIVE MANAGEMENT    menu to restore data previously  stored on BACKUP media to the archive     In order to restore data   Select the backup unit  floppy disk drive A  by default   Select what to restore    Whole archive  default   One particular year only    e o opne    One particular month only     Then select the year and or month to be restored and insert the disk labelled  Restore Disk  in the  chosen unit  for example floppy drive A       Once done  click the  DONE  button to start restoring the data  If necessary  insert the other  numbered disks in the order in which they are requested     Note  button    Remote Host    will be explained into appendix A     Page 20 52    ARCHIVE MANAGEMENT   DELETION    Store  Bean by Date  Bean by Name   piety   Restore Piete  emote Host    elete Options    Delete Year          Delete Month       Delete Support               Confira   Abo       Select  DELETE  from the  ARCHIVE MANAGEMENT  menu to delete all or part of the  atchive   First of all  select the type of deletion required     e Delete Year  e Delete Month  e Delete Support     Once the support has been selected  you may also choose to delete only certain graphs     By default all graphs are selected for deletion  To prevent certain graphs from being deleted  deselect  them by
4.   Insert a minimum between two fractions  Delete a minimum between two fractions  Correct the baseline   Calibrate the value of a fraction  Highlight a fraction by dividing it  Change the fraction label  name    Restore a graph    Print a graph    Left click one of the icons on the correction menu to select the type of correction required  Right click  to deselect it     Page 23 52    DELETE TRACE AREAS  When this button is clicked  a vertical light blue line appears which may be positioned at the point  where the area to be deleted is found using the mouse   A yellow square appears next to the displayed graph showing the optical density  O D   of the trace   This parameter changes with the movement of the cursor line   The O D  is useful when determining the position where deletion is necessary   By left clicking the first half of the graph  everything between the beginning of the graph and the cursor  line is deleted  by left clicking the latter half of the graph  everything between the cursor line and the  end of the graph is deleted   Right clicking or selecting another button from the correction menu cancels the deletion function     INSERTING MINIMUMS  When this button is clicked  a vertical light blue line appears which may be positioned at the point  where the minimum is to be inserted using the mouse   A yellow square appears next to the displayed graph showing the optical density  O D   of the trace   This parameter changes with the movement of the cursor line   The
5.  O D  is useful when determining the position where the minimum is to be inserted between two  graph fractions   Left click to insert the minimum   Right clicking or selecting another icon from the correction menu cancels the minimum insertion  function     REMOVE MINIMUMS  When this button is clicked  a vertical light blue line appears which may be positioned on the minimum  to be removed using the mouse  Left click to remove the selected minimum   Right clicking or selecting another icon from the correction menu cancels the minimum removal  function   A yellow square appears next to the displayed graph showing the optical density  O D   of the trace   This parameter changes with the movement of the cursor line   The O D  is useful when checking the position of a minimum between two graph fractions     EDIT BASELINE  This function is useful for correcting supports which have undergone uneven destaining  and therefore  have ODs above the baseline value at the beginning or towards the end of the graph   In this case the graph must be corrected so that its beginning and or end have a uniform O D  value  equal to zero   When this button is clicked  two adjustment bars appear along side the graph which may be used to  move the baseline where necessaty   Select one of the two bars by left clicking  and adjust the corresponding cursor either using the cursor  keys on the keyboard or by dragging with the mouse  hold the left button pressed   Adjust the other  cursot if necessary in 
6.  The graph is restored when it is displayed  Once a new support has been displayed  it is no longer  possible to go back and restore the original state of a previously displayed graph     PRINT GRAPH  Click this button to print the graph displayed   Printing takes place according to the settings made by choosing  VARIOUS  from the   CONFIGURATIONS   menu      Page 25 52    F    Serum proteins Haemoglobin       Exam Name     SERUM PROTEINS    Applicator Step           Fractions   minte _  max  min gfdt  Max gja    amp  Micro p gt   ff   ae a 4  __y    Semimicro       pret  igration    10 0   mAN  4 0E20E0HIMA    Td Current is Constant    Multizone       Select  EXAM  from the  CONFIGURATIONS  menu to configure the parameters for individual  tests   The following parameters may be configured on this screen for each test     Test name   Number of fractions and their names  max 10      reference tables   g dl reference table for total proteins   Deposition step  MICRO and SEMIMICRO   Number of points to eliminate in the deposition area  Migration voltage   Migration current   Multifractionation technique  serum proteins only     Method operating values    Note  you can change the test name in order to rename a pre defined exam     Page 26 52    A new name is automatically selected for a fraction  or edited  after the name of the fraction itself is  written  If the FRACTIONS field is not completed  the fraction itself is not included in the graph  minimums calculation    Numerical
7.  left clicking     Page 21 52    3 5 DISPLAY GRAPHS    After preparing measuring a support  its graphs may be displayed     The  DISPLAY  menu shows a list of available supports  prepared and measured    By selecting a support with the mouse  a preview appears where it is possible to display the contents of      vetrino n   1 del 18 02 2002   SIEROPROTEINE       TRACCIATO NON YALIDO   TRACCIATO NON YALIDO   TRACCIATO NON VALIDO             the whole support and immediately see if any errors have occurred during the preparation and  measurement stages     In order to leave the preview of the entire support and display the individual graphs for editing or  correcting  simply click the mouse on one of the traces displayed     Note   In order to display traces retrieved from the archive  select    DISPLAY    again from the     PATIENT LISTS      gt  PATIENT ARCHIVE    screen     It is possible to display both the patient data associated with a graph and the percentage values of its  individual fractions from the individual graph correction and display menu     Page 22 52    Every graph has a correction menu with icons placed along side it         Yetrino n   1 del 18 02 2002   SIEROPROTEINE    AMARI LETIZIA 101234 roam  50  Sesso  F   2   Prelievo del   Reparto   a    22 5 10 0    Note di Commento    Questo    un Commento    Ogni riferimento a persone  realmente esistenti    da ritenersi  casuale     l Ferogramma  mr         From the menu it is possible to    Delete a trace atea 
8.  left part shows the sample grid  seen from above  and the right  consists of buttons for the methods and functions which may be carried out  support preparation   support measurement or both      The sample grid is arranged in rows from top to bottom  Therefore row 1 corresponds to support 1   row 2 to support 2  etc   the position of the first sample in each row is indicated by a yellow dot     Therefore by selecting a row from the sample base  you also select the position of the support to be  used        f f      Unselect All 3 i j    Serum pyoteins Haemoglobin Urinary proteins    aa gaeane  i  inn f  amp   amp   amp  ie Lipo proteins    i dl  ee  v Prepare Supports   v Read Supports  J Read Suppo       All you have to do after that is select the type of test required by clicking the corresponding button     Note that by default the MS is set for support preparation and its subsequent measurement  the two  checkboxes are selected   Therefore  if you only wish to do one of the two functions  deselect the  option concerned by pointing the mouse at the checkbox and left clicking  the box is no longer  selected      Page 12 52    e Once the supports samples to be used and the test to be performed have been selected a button  marked    Start    appears     By clicking this button  the chosen process starts and a status screen appears which shows the progress  of the various stages of the method for each support  as well as data regarding certain parts of  ELEPHOR 24S  migratio
9.  percentage values are expressed as       for example 12 7   i e  with only one decimal place  and a decimal point separator  The program beeps if characters or numbers with a different format are    typed in     After inputting the min max   reference table  a congruity test may be carried out by clicking the    T     key found beside the table     Any errors found are automatically highlighted in sequence by a box which appears on the cell s   containing the incorrect value s    The min max total proteins reference values in g dl together with the min max   reference table  determines the min max reference table in g dl for the single fractions   For example   Min  ALBUMIN value in g dl   Min  g dl value for TOTAL PROTEINS   Min    value for  ALBUMIN    If a SEMI MICRO deposition step is chosen  only four traces may be selected  choose  CURRENT  DATA  from the  PATIENT LISTS  menu      The odd traces are available for measurement  whereas the even ones are automatically defined as  NOT VALID     On this screen  you can choose whether to carry out constant voltage or constant current migration for  the type of test concerned and set the appropriate value     Clicking the    METHOD    button displays a new screen where the time of operations performed by  ELEPHOR 24S may be edited  All times are in seconds  changing these times changes the method and  affects the quality of the traces produced  The default method parameters are a good compromise  between process speed and res
10. 150 ml of buffer solution until the compartment level reaches  the reference line  level off the quantity between the two compartments    4 Put the electrophoretic chamber back into its slot and push home    5 Pull out the sampler and pipette 25 30 ul of sample into each well  1   fig  2 1 1     1        Fig  2 1 1    6 Fill the depositor washing compartment  2  with 1 ml of bidistilled water   7 Insert the special strip of absorbent paper in the compartment  3  in position E on the treatment  rack   8 Put the sampler back in place and push home   9 Place the applicator on the support plate in position D  Fig  2 1 2    10 Place the supports to be prepared on the support plate  1 3 in Fig  2 1 2    11 Run the ELEPHOR 24Ssoftware to start the operating cycle        Page 8 52    2 2 ELEPHOR 24S MANAGEMENT SOFTWARE START UP        Turn the computer on and let the operating system  Windows 9x  start up        When the Windows Desktop appears  fig 2 2 1   click the start button and choose ELEPHOR  24Sfrom the menu  or point the mouse at the ELEPHOR 24Sicon on the Windows Desktop and  double click     Note   to avoid visuals artifacts set Windows    Desktop theme in    Windows classic    mode     ELEPHOR       msaasa   esea as    Follow the instructions in section 3 2 to start working     Page 9 52    The Management Software provided with the ELEPHOR 24S analyser allows electrophoresis traces  to be selected  customized  corrected  stored and printed through an intuitive hierarchica
11. 2    1 4 INSTALLATION    The instrument must be placed on a perfectly flat surface in a room with a temperature of between  15  C and 30  C and humidity of 40 80  max  Make sure the ventilation slits are not obstructed and  leave at least 10 cm of space behind the back panel         Remove the lock screw from the mechanical arm before use      Connect the USB cable provided to  USB  connector on the left panel of the instrument  fig  1 4 1   and connect the other end to the computer USB hub        RESET Button    Link to P C  USB    fig  1 4 1    Power Plug  Main Power Switch            Connect the power cord to the Power Plug      Connect the five connectors on the back of the instrument  fig  1 4 2  using the tube provided    D  0 9 8           Whete     1   stainer tank   2    destainer tank   3    buffer tank   4    washing solution tank and  5  waste tank    Page 6 52    2 0 TURNING ON    To turn the instrument on press the power switch on the left panel of the device  the system starts to  move back to the home position     Note  during the first activation  be sure to remove the lock screw from the mechanical arm      Page 7 52    2 1 INSTRUMENT PREPARATION    Before starting an electrophoresis process  prepare the electrophoretic chamber in the following way     1 Pull the electrophoretic chamber out from its slot by the sides  Place the two floats in the electrophoretic chamber and fasten them using the support with  holes provided   3 Fill the two compartments with 
12. IENCE MANAGEMENT  Configuring species  Managing species    TROUBLESHOOTING  REMOTE HOST INTERFACE SPECS    Page 3 52    34  35  36  37    40  40  41  42  43    44  44  46    47  50    10 DESCRIPTION OF THE INSTRUMENT    ELEPHOR 24Sis able to perform the electrophoretic procedures of the following clinical tests  automatically       Serum proteins    Haemoglobins     Lipo proteins     Urinary proteins    furthermore additional tests may be created and customized  such as Serum protein multifractionation   ELEPHOR 24S uses supported cellulose acetate strips which are managed completely automatically   Simply insert them in the appropriate slots and tell the machine which strips to use    The patient archive is stored on an external computer  HOST  connected to the machine through a  standard USB cable  The number of patients which can be stored in the archive  never less than  100 000 in any case  therefore depends on the capacity of computer s magnetic storage medium   HARD DISK      11 STANDARD COMPONENTS    ELEPHOR 24S comes complete with the following standard components         Eight thin plate serum applicators for MICRO methods       24 place sampler  3 supports x 8 samples        3 supports for cellulose acetate strips       1 reagent tank with two compartments for automatic reagent handling       Usb cable       Power cord       Destainer  washing and waste tank connection tube  external diameter   5 mm  internal diameter    3 mm        One reagent tank  buffer        
13. M  M       Support 1 19 11 2004       Select  PATIENT ARCHIVE  from the  PRINT  menu to print the support selected from the  patient archive   When this option is selected  all the valid graphs for the support are selected for printing     Graphs may be deselected by left clicking beside the traces which you do not wish to print   Once selection is complete  click  DONE  to start printing     Printing may be interrupted at any time by clicking the  CANCEL PRINT  button on the top right of  the screen     Page 31 52    ji  From Database   stork List    Support 1 Support 2 Support 3      Confit            Select  CURRENT DATA  from the  PRINT  menu to print the supports produced during the  operating cycle   When this option is selected  all valid supports and graphs are selected for printing     Supports and or graphs may be deselected by left clicking beside the supports or graphs you do not  wish to print    Once deselection is complete  click  DONE  to start printing the graphs    Printing may be interrupted at any time by clicking the  CANCEL PRINT  button on the top right of  the screen     Page 32 52    4 0 MAINTENANCE    4 1 DAILY MAINTENANCE    At the end of each work session  it is advisable to carry out the following cleaning operations         Wash the serum plate under running water and dry with absorbent paper       Empty the electrophoretic chamber and recycle the buffer  remove the floats from their housings   rinse them with deionized water and leave them to dr
14. Manuals       ELEPHOR 24Ssoftware CD ROM    Page 4 52    1 2    1 3    TECHNICAL CHARACTERISTICS    Power supply voltage  220 V 50Hz   Power consumption  250 W max   Automatic reagent loading and handling   Sample refrigeration by a Peltier cell   Reagent  buffer and stain  recycling upon job completion  Pluid circuit washing routine upon job completion  Electrophoresis power supply unit with voltage  100V 300V   and current regulation  7mA 30mA   Pneumatic support handling   Operating capacity of 16 tests per hour   Measurement with non cleared supports   Dimensions  WxHxP   56x46x54 cm   Weight   30 Kg    HOST COMPUTER REQUIREMENTS    The minimum configuration for correctly interfacing with the ELEPHOR 24Ssystem is     700 MHz PENTIUM III PC  or equivalent   128MB RAM   1 2 Gbyte hard disk   800x600 resolution 65000 colour video adapter  15    monitor   2X CD ROM drive   Windows XP SP1 operating system    Recommended configuration     1200 MHz PENTIUM III PC   256MB RAM   1 2 Gbyte hard disk or better   800x600 resolution 16 million colours video adapter  17    monitor   2X CD ROM drive or better   Windows XP SP3 operating system or better    About 30MByte of free space is needed on the hard disk for installation  The remaining space may be  used for the patient archive until full     Note   to avoid visual artifacts set Windows    Desktop theme in    Windows classic    mode and  set numeric format in    0 00    notation using          dot  as decimal separator     Page 5 5
15. N network  serial connection  etc     physically connected to the  analyser and the remote host  Such operation does not need the information provided herein and is  pertaining exclusively to the final user and or the host program providers  Interfacing the two  computers requires the compliance with the standard rules of LAN connections or other  management specifications allowing text file exchange and folder sharing by two or more  computers  please note that if you have computers running under Windows 2000 XP or Linux  you  may need to configurate the user accounts with administrator rights     In general  you just need to share the NetDir folder of the computer the analyser is connected to and  a folder of the computer the host is part of  such folder will be indicated in the ELEPHOR 24Snet  program configurations     Coding of acceptance data    Acceptance takes place through a text file in the NetDir folder sent by the remote computer  such  file will have a fixed name followed by the extension     txt     typical of text files   Eg    Acceptance txt    The acceptance host software shall take exclusive care of the removal of such file from the NetDir  folder  the updating of the data contained therein shall be made concurrently by the two software   ELEPHOR 24S and the host program   consequently we recommend the use of methods allowing  to synchronise the file access by the acceptance host software     Acceptance file data format    The acceptance file is an unformatt
16. PROTEINE             Support 8   SIEROPROTEINE    Support 9   SIEROPROTEINE       Confirm          JKKK                When this option is selected  all valid supports are selected for storage   Deselect any supports you do not wish to save by left clicking beside them   Once selection  deselection is complete  click  DONE  to start saving the graphs in the archive     Page 16 52    ARCHIVE MANAGEMENT   SEARCH BY DATE    Select  SEARCH BY DATE  from the  ARCHIVE MANAGEMENT  menu to search for a  support in the archive by its storage date     Select the year  then the month then the day concerned  a list of supports stored on the date input  appears  Scroll through the list to find the support required       Store Eain by Date  Beareh by Name   Backup   Restore   Delete  Remote Host    ADDON 1 SIEROPRO TEINE  i iaa aa  Support 2 SIEROPROTEINE    Support 9 SIEROPROTEINE       Once selected  click  DONE  to load the support     The patient data for the chosen support may be displayed by choosing  PATIENT ARCHIVE  from  the  PATIENT LISTS  menu     Page 17 52    ARCHIVE MANAGEMENT   SEARCH BY NAME      Store  Beare by Date rath by Name   Backup   Restore   Delete  emote Host    123456789 SIEROPROTEINE 1271704  444123456 SIEROPROTEINE 1271704  LOL123455 SIEROPROTEINE 1271704  SIEROPROTEINE 1271704  SIEROPROTEINE 1271704  ACABEBACC SIEROPROTEINE 1271704  SIEROPROTEINE 1271704  SIEROPROTEINE 12 1 04       Select  SEARCH BY NAME  from the  ARCHIVE MANAGEMENT  menu to search for a  su
17. Problem    Probable cause    Soluzione       Too high migration current  over 10  mA    Migration at constant voltage     Wrong dilution of the buffer  too much  concentrated    Acetate membrane too much wet before  migration    Replace the buffer solution correctly diluted   1 10    Increase the drying time 1 in the method  parameter configuration  up to 120 sec         Too high migration voltage  over 250  volts    Migration at constant current     Too dry acetate membrane    One or both wicks are glided down respect  their correct position    Decrease the drying 1 time on the method  parameters configuration  up to 30 sec     Replace the wicks assuring the correct  position       Distortion on migrations    One or both wicks are glided down respect  their correct position   Too high buffer solution level in the  electrophoretic chamber    Acetate membrane is too wet before the  migration    Replace the wicks assuring the correct  position   Recheck the buffer solution level in both  sides of the chamber  up to reach the  contact with the wicks  total buffer volume   150 ml  equally distributed in the sides of  the electrophoretic chamber    Increase the drying 1 time on the method  parameters configuration  up to 120 sec         Insufficient staining of the fractions   too low alpha1 fraction     Exhsausted staining solution  Destaining solution too diluted    Too low quantity of samples in the wells    Replace the staining solution   Replace the destaining solution with w
18. R 24S software when such patient is accepted     lt Sentflag gt  boolean flag indicating the occurred dispatch by ELEPHOR 24S software of the report  data relating to that patient  It is set at  lt F gt   False  by the host the first time the acceptance file is  sent and is modified into  lt T gt   True  by ELEPHOR 24S software when the report data are sent     Typical line examples of an acceptance file  please note that the use of characters  lt  gt  is only the  result of an agreement in order to highlight the used fields and characters  they are not shown in the  text file    Acceptance of Seroproteins    MARIO ROSSI33 M  15 09 02 0001 6 0  HAEMATOLOGY  1 F F lt CR gt  lt NL gt     when the test is accepted the line becomes   MARIO ROSSJI 33 M  15 09 02 0001 6 0  HAEMATOLOGY  1 T F lt CR gt  lt NL gt     when the test is sent to the remote host  the line becomes   MARIO ROSSI 33 M  15 09 02 0001 6 0  HAEMATOLOGY  1 T T lt CR gt  lt NL gt     Now  the report data of the patient MARIO ROSSI are available and the remote host may retrieve  them from the report file     For partial acceptance  for example  with no information about age  gender  Total Proteins and  department you would obtain the following     MARIO ROSSL lt SP gt   lt SP gt   15 09 02 0001  lt SP gt   lt SP gt  1 F F lt CR gt  lt NL gt     When the field  lt Sentflag gt  becomes  lt T gt  the data have been keyed in the report file and may be  decoded and processed by the host     Page 51 52    Report file spe
19. TEINE 12 1 04  LOL1Z3455 SIEROPROTEINE 12 1 04  SIEROPROTEINE 12 1 04  SIEROPROTEINE 12 1 04  ACABBBACC SIEROPROTEINE 1Z 1 04  SIEROPROTEINE 12 1 04  SIEROPROTEINE 12 1 04          To send Database items to a remote host you must   e Select the button  Database  from the main screen  Press the button  Remote Host     Search the items to send using the name  exam and data filter  Select items you want to send  Press the button  Send     Page 43 52    APPENDIX B VETERINARY SCIENCE MANAGEMENT    This appendix describe program items to manage animal species  by using a dedicated software  program   version  V     All things described for the standard version are valid too     B 1 CONFIGURING SPECIES    Using the  Settings  window you can create for each exam one or more species with a particular range  of normal values and a particular number of fractions max 10 fractions      Note  Veterinary program version doesn t allow the creation of a user defined exam     Ben    Varig ME Reagents   Host Remoto        f      Sieroproteine   Emoglobine    Esame Selezionato       SIEROPROTEINE  Pet  dieataa    asso di Lettura        5  9 Micro SPECIE    CANE    Semimicro pe    EFAULT 2    igrazi DEFAULT 1    igrazione                  _ ii 1   DEFAULT 3  D    EFAULT 4     EFAULT 5 z  10 0   MAR  C A 0ER20FE0IMA    e         Id Migra a Corrente Costante    a   PO    Proteinemotall  Multifrazionata         Pressing the button  SPECIES  will appear a drop down menu where you can     1  Create a 
20. cifications    The report file is organised very similarly to the acceptance file  an unformatted text file containing  the patient   s data and the report data including the scan data     Individual report line data format      lt Name gt   lt age gt   lt gender gt   lt data gt   lt Idcode gt   lt TP gt   lt department gt   lt Testcode gt   lt Acceptedflag gt   lt Sen  tflag gt   lt Testname gt   lt RefMinPT gt   lt RefMaxPT gt      lt NumRef gt   lt RefMinPct1 gt       lt RefMinPct NumRef gt   lt RefMaxPct1 gt       lt RefMaxPct NumRef gt     lt NumVal gt   lt ValPct I gt        lt ValPct NumVal gt      lt Labell gt       lt Label NumVal gt      lt NumMarks gt   lt Mark 1 gt       lt Mark NumMarks gt      lt NumPoints gt   lt Point1 gt       lt Point numPoints gt  lt CR gt  lt NL gt     The same rules of the acceptance file are applicable and the initial fields are identical to those of the  acceptance file  Now let us examine the report specific fields      lt Testname gt  string indicating the test name as it is shown on the analyser   lt RefMinPT gt  float string type min reference value for Total Proteins in g dL  format 0 00      lt RefMaxPT gt  float string type max reference value for Total Proteins in g dL  format 0 00      lt NumRef gt  this value indicates the number of elements forming the test reference table  followed  by NumRef values being the percentage minimum reference values  followed by NumRef values  being the percentage maximum reference values  All va
21. dow is active   USB cable is not connected to the P C   correctly    Turn on the analyzer   Reset the analyzer by pressing the Reset  button and re run the software   Control the connection of the cable between  the analyzer and the P C  host       Serum sample is not in appropriate quantity  or it is not uniformly dispensed in the serum    Remove the serum samples from the plate  and re add  well distributed  a sufficient       electrophoretic chamber    Acetate membrane is bad mounted on the  plastic frame    2  Samples are not applied correctly on   plate quantity  25 microliters each   the acetate plate Tips of applicator are not independed the  Clean the applicator assuring the  one from the others indipendent moving of each tip  Damaged applicator tips Replace damaged tips with new one  Acetate membrane is too wet before the Increase the drying 1 time on the method  application of samples parameters configuration  up to 120 sec     increase the application time  up to 25 sec    Insufficient migration current One or both wicks are glided down respect  Replace the wicks assuring the correct  their correct position position  3 Insufficient buffer solution level in the  Refill the buffer solution in both sides of the    chamber  up to reach the contact with the  wicks  total buffer volume  150 ml  equally    distributed in the sides of the  electrophoretic chamber   Assure the correct mounting of the    membrane on the plastic frame                      Page 47 52          
22. ed text file the lines of which are the acceptance data of an  individual test in the following form      lt Name gt   lt age gt   lt gender gt   lt date gt   lt Idcode gt   lt TP gt   lt department gt   lt Testcode gt   lt Acceptedflag gt   lt Sen  tflag gt  lt CR gt  lt NL gt     The following rules are applicable      Each line consists of a set of 10  ten  string type fields separated by a comma     Each line ends with a character  lt CR gt   Carriage Return  and a character  lt NL gt   New Line      Each field must be indicated  for the fields that are not desired just key in a character  lt SP gt    SPace  and maintain the correct sequence as above specified     Field meaning     lt Name gt  Name of the Patient the test is relating to  max 30 characters    lt age gt  age  max 3 characters     lt gender gt  gender  1 character M F     lt date gt  date related to the test in dd mm yy format  this field must be compulsory    lt Idcode gt  patient identity code  max 9 characters     lt TotalProteins gt  float type value  format 0 00 accounting for total proteins   lt department gt  name of relevant department  max 25 characters     Page 50 52     lt Testcode gt  test code  1 Seroproteins 2 Haemoglobins 3 Lipoproteins   This field is  COMPULSORY     lt Acceptedflag gt  boolean flag indicating the occurred acceptance of the test relating to that patient   It is set at  lt F gt   False  by the host the last time the file is sent and is modified into  lt T gt   True  by  ELEPHO
23. ell  diluted one  dilution is   1 20    Remove the serum samples from the plate  and re add  a sufficient quantity  25  microliters each    well distributed             Inhomogeneous destaining of the  acetate membrane background       Destaining tank empty during the analytical  cycle       Check  before the startup of the machine   the presence of enough destaining solution  in the external tank  for a complete cycle of  3 membrane  the minimum quantity of 500  ml is required        Page 48 52          Truncation of the gamma fraction in    Back migration of the gamma zone fraction    Decrease  in the params configuration  the          9  the graph during the migration deposition line value  up to 130  and re scan  the membrane  before to re scan  please  assure the complete drying of the  membrane   Gamma fraction is moving forward Too high migration Tension Currente at See points 4 and 5   10   respect the application point the startup                Page 49 52       REMOTE HOST INTERFACE SPECS    Remote Host Specifications    The data relating to a test and to the patient related thereto are sent by a remote computer  host  by  sending a text file to the NetDir folder of ELEPHOR 24S management program  located on the  local PC connected to the instrument  The coding of the data contained in such file will be  explained later in this section     Requirements  in order to properly interface ELEPHOR 24S analyser with a remote host  first you  have to network the PC  by a LA
24. firm    First create a control sample pressing the button  New Control     after selecting the exam by the drop down menu and fill in the text box    Control    with the name that  identify that caontrol    Fill in the bottom grid from left to right with the theoretical values of the control and click on     Confirm        Page 35 52    5 2 MODIFING CONTROL DATA    Once you create the control is always possible to change the values expected in the following way    e Select the exam   e From the control box  select the name of the control to change   e Once you pop the grid values  select the  Edit  button and proceed to the modification of values in    the grid    Quality Control        TEST CONTROL1 ba  SIEROPROTEINE hd             Modify                   Control      E    SIEROPROTEINE x    New Control    Delete Control       Referenc lues     Se  Ea   e FE AS   a  2 0 7 8 12 4 17 6    Search       50 2    Confirm                   Click on    Confirm    to store the modified data     Page 36 52    5 3 DELETING A CONTROL    To delete a control from the list of available controls  select the Exam and the control name as done in  the previous paragraph once the pop up screen        New Control    Delete Control       ren es    a ae eee   ee  ce        2 0 7 8 12 4 17 6    Search       Confirm                   Click on    Delete Control    and press    Confirm    to submit the operation     Page 37 52    5 4 EXECUTION OF A QC STATISTICS    To perform a useful statistical QC 
25. for a monthly or annual review and select the control you want to  make statistics and press  Search      LOTTO XYZ PATOLOGICO bs Nuovo Controllo  SERUM PROTEINS sf    Elimina Controllo    Ricerca    E egui oc  Cancella    Annulla    Annulla                It will appear a box with a list of all the years of work in which the reference control was used  clicking  the right mouse button on the year with a series of options appear     e Run QC  QC statistics starts and displays the result  e Delete  delete the selected item  Year   Month  from the QC  e Abort  Closes the menu    If the entry for the year you left click mouse  a screen appears containing the list of months  the year  selected  which was used as the reference standard     Controllo   LOTTO XYZ PATOLOGICO bd Nuovo Controllo  Esame   SERUM PROTEINS sd    Elimina Controllo       Ricerca       FEBBRAIO20  MARZO2007 Cancella    4nnulla    Annulla                Page 38 52    Now right click mouse menu appears as described above from which to start statistics on the option  with the click left button           Coeff  Variazione               15 01 07    Stampa Annulla    Controllo Eseguito su3 punti          The screen displays the average values for each reference sample  relative to the day of the month in  which it was performed for each portion of the examination in which the QC will appear    Reference value   Median   Variance   Diversion   CV    The total number of points on which it is performed to Statistical 
26. he right box clicking on the little box on the left of the patient name by the  left button of the mouse  Press the right button to select all patient listed into the box    When you have selected some patients press the    Select Items    button to add this selection to the  sample grid           Note  you can select only a single exam list per operative cycle     Pressing the button  Delete All Selections  all elements selected for that exam will be deselected   pressing the button  Delete Last Selection  the last elements queued are deselected     To obtain a printed work list press the button  Print All Selections      Page 41 52    A 3 SENDING DATA TO THE REMOTE HOST    REMOTE HOST  SIEROPROTEINE      Items Received   fi  Items Selected   fo  Items Sended   fo    Select Items    Delete Last Selection    je eee  ei ad   Delete All Selections    pea ea     Print Last Selection    Print All Selections   Items Sended   Items To Send   Send Items      To send the results of an exam to the remote host you must           Press the button Start from the main screen an then select  REMOTE HOST   Press thebutton  Items To Send    Select items into the box   Press the button  Send Items     It   s also possible to send data from the local database to the remote host  see next session      Page 42 52    A 4 SEND DATABASE ITEMS TO REMOTE HOST      Store  Eee by Date Ee Name   Backup   Restore   Delete Bemote Host       ID EXAM DATE  123456783 SIEROPROTEINE 1Z 1 04  4B4123456 SIEROPRO
27. l organization   Every function or group of functions is brought together on a single screen  which can be selected  from the main panel by simply clicking the corresponding button    Geir seit Bfoewocierosis J yai versie hii         Database       Work Lists m Start s Corrections       Settings    2O 2 ET EE         1  Archive Management Button   2  Patient List Button    3  Start Button    4  Graph Display Button    5  Configuration Button    6  Print Management Button   7  Quality Control Button    Page 10 52       Before starting a    work routine    you must Log in into the software  default user name ADMIN with  password admin  and choose the type of test and the number of supports the sample to be analysed is  to be deposited on  The position of the support corresponds to the position of the samples contained  in the sample holding base     To select a test and the samples to prepare and or measure  carry out the following procedure on the  Management Software  hereinafter referred to as MS  main screen     e point the mouse at the    Start    button and left click     ei EG stead Elasin Jyly garaje Lij    A ER EEES  i   Work Lists Y Corrections        Settings   Print       Page 11 52    the following screen appears           Unselect All          Serum proteins Haemoglobin Urinary proteins    Saag agueaeme      inne ft   tm Lipo proteins    ete    oe Td Prepare Supports  Yd Read Supports    BB Read Supports  Immediate           the screen is split into two areas  The
28. lues of reference tables are of float string  type in format 0 0  so following the  lt NumRef gt  field there will be 2 NumRef values forming the  percentage reference tables  To retrieve the reference tables expressed in g dL use the parameters  RefMinPT and RefMaxPT with the percentage Min Max reference tables      lt NumVal gt  Number of elements forming the table of the read concentration values  such value  takes also into account a fraction partitioning values  Then there area NumVal values being the  percentage concentration values    All concentration values are of float string type  format 0 0   These are followed by NumVal strings  lt Labell gt       lt Label NumVal gt  representing the names of  fractions and partitioning  please consider that the partitioning names are always preceded by a  character  lt   gt   at     In order to obtain the concentration values expressed in g dL use the TP value  if available  and the  percentage concentration values     lt NumMarks gt  Number of elements being fraction marks  followed by NumMarks values of full  type representing the abscissa where the fraction marks are shown  such values are associated with  the scan data values     lt NumPoints gt  Number of points being the scan  followed by NumPoints values of full type being  the scan curve    The report file name reflects the rules of the acceptance file  it will be of    Report txt    type  The host  management program takes care of the removal of such file from the folde
29. n voltage and current  and the levels of the reagents in the tanks     Note  it is advisable to wait until ELEPHOR 24S has carried out all the initialization operations before  leaving the MS workstation unmanned  if necessary  since error messages may appear which must be  corrected by the operator so that the processes may be restarted correctly     One typical error which may occur is insufficient reagent in the storage tank  In the case of a method  with automatic reagent level handling  this results in failure to reach the operating level and leads to the  corresponding error message     Once the ELEPHOR 24S has started up correctly  the MS workstation may be left unmanned     In order to correct an error  the operator must fill the corresponding reagent storage tank  click the     Continue    button on the error screen  and click the    Start    button on the main screen again     Note  button named    Remote Host    will be explained into appendix A    Page 13 52    This button opens a screen with information relating to the patients to be tested  Up to 24 patients may  be managed at a time  8 patients x 3 supports  plus eight other patients which may be retrieved from  the archive using search functions        ins lrlinlincre Actttalllis      Support 1 Support 2   Support 3    Name v cge    m n a j L N          The  PATIENT ARCHIVE  menu contains the data relating to the support selected from the  archive     The patient s data  name  surname  age  etc   and total pro
30. new species  2  Select a species  3  Delete a species    You can create a species by pressing the button  SPECIES  and choosing  Create Species   it will be  created a new table of normal ranges and a new label where you can input the name of the created  species     Page 44 52    To delete a species press the button  SPECIES  and choose  Delete Species   it will appear the list of  species available where you can select the item to delete     Note  the default species cannot be deleted  but can only be modified in all its parts     Page 45 52    B 2 MANAGING SPECIES    Species management can be done for each sample by selecting the appropriate species item into the   Work Lists  window    Where not stated  default species parameters are used    Samples recalled from the database not allow species to be changed     Archivio Pazienti We Attiali   Stampa lista    r    Supporto 1   Supporto 2   Supporto 3    Molina ive    T oF  T F  pecs    a 25  Jo F    TEST3_6    frests    oo  eyes    ELETTROFORESI BELLE SIER PROTEINE       To change a species on a sample click on the drop down list button into the field  SPECIES  and  select the species you want  To change the species all eight samples in one pass click on the button   SPECIES  and make your selection     Page 46 52    APPENDIX C TROUBLESHOOTING       Problem    Probable cause    Solution       1   Analyzer not linked to the P C  Host    The analyzer is turned off   The analyzer is on and the Busy indicator  on the status win
31. pport in the archive by the patient s name  the patient s exam or id code  any combination is valid      Type the patient s name into the appropriate field to start searching  the result is highlighted in blue     Left click the result to select the patient found along with the types of tests concerned and their storage  date and press Confirm to display it     The patient data relating to the graph and support selected may be displayed by choosing  PATIENT  ARCHIVE  from the  PATIENT LISTS  menu     Page 18 52    ARCHIVE MANAGEMENT   BACKUP      Store  Bean By Date  Bean by Name Bk   Restore   Delete  emote Host       C A Year        amp Month          It is advisable to save the archive data periodically on a floppy disk or backup unit  for example  IOMEGA ZIP    Select  BACKUP  from the  ARCHIVE MANAGEMENT  menu to save all or part of the data  archive   In order to make a backup   1  Select the backup unit  floppy disk drive A  by default   2  Select the type of backup  e Whole Database  default   e One particular year only  e One particular month only     Then input the year and or month to be saved   Once done  click the DONE button to save the data on the backup media selected  for example floppy  disk A      In the case of floppy disks  the backup procedure may require more than one disk  it is advisable to  number each disk used during the procedure   The last disk must be labelled  Restore Disk  and may be used to restore the data saved if necessary     Page 19 52  
32. r     Page 52 52    
33. reserved for the header of the printed report  it   s possible to  modify font  size and text formatting      Notes at Bottom of Page   this space is used to print fixed text at the bottom of values     Additional Line at the Bottom Of Page   a single line can be typed in which is printed under the  footnotes with the same layout as used when writing      Print Report in Colour   it is possible to choose either a colour or black and white trace printout   This selection only refers to the trace printout  Depositions are normally printed in red      Mark Values out of Range   this option prints any fraction values which are out of the normal range  in bold      Kit Management   it   s reserved for analyzers with smart card reader     Page 29 52       e   Remarc tsact      nN Gc  6  i es    Reagents    Recycle   Clean    MENEGES Singe RE e ene       It   s not a real configuration  but it offers a way to manage some operations on Reagents individually   Fill  Flush  Recycle   In this screen it is also possible to Recycle all Reagents  Recycle button  or to  Recycle Reagents and Clean Sides  Recycle   Clean button      VERY IMPORTANT NOTE   YOU MUST BE SURE THAT ALL CONNECTORS OF SIDES ARE PLUGGED IN      ANYWAY IT MAY RESULT IN DAMAGES TO THE CIRCUIT OF REAGENTS     Page 30 52    The whole printing process may be set up in one place on this screen  where the graphs to be included  in the report may be selected        UNKNOWN JHON  NONAME MICHAEL  NAMELESS JOLANDA       M  M    
34. teins value may be edited   The  SHOW  button displays the graphs which correspond to the selected support   Any corrections or changes to the traces displayed may be made on this screen     Page 14 52    Acttalllus    Support 1 Eresi eae  3          Select  CURRENT DATA  from the  PATIENT MANAGEMENT  menu to input the patient  data corresponding to the pherogram to be measured    Once this function is chosen  the set of selected supports appears and it is possible to input patient data  for all the supports displayed     Simply type the surname  name  sex  sampling date  the default is always the current data   patient ID   total proteins and department into the Patient Data table  The Q C  field is used to select a previously defined Control     Page 15 52    3 4ARCHIVE MANAGEMENT    This screen provides complete control over the report archive  Patients may be searched for by name  or by storage date  reports which have not yet been stored or edited may be saved  and data may be  backed up on removable media or deleted     ARCHIVE MANAGEMENT   STORE    Select  STORE  from the  ARCHIVE MANAGEMENT  menu to save the supports measured  along with the corresponding patient data in the archive     a Store  Bean By Date  Bean By Name   Backup   Restore   Delete  emote Host    SELECT SUPPORTS TO STORE    Support 1   SIEROPROTEINE  Support 2   SIEROPROTEINE  Support 3   SIEROPROTEINE  Support 4   SIEROPROTEINE  Support 5   SIEROPROTEINE  Support 6   SIEROPROTEINE  Support 7   SIERO
35. the same way   Once cursor adjustment is complete  click the button again and correct the graph baseline obtained by  moving the end points of the trace onto the zero O D  line     CALIBRATION FRACTION  The   value of a single measured fraction may be calibrated applying a calibration factor  When this  button is pressed a grid of values will be displayed  Set the single calibration factor by changing the  value and pressing the    Enter    key to validate it  After you changed the values click on    Confirm    to    apply it     Page 24 52    SET FRACTION NAME  Click the grid containing the fraction names to display an input box where a new name for the fraction  or sub fraction may be input     INSERT NEW FRACTION  Right clicking on the grid containing fraction names it will be displayed an input box where setting a  new fraction name and a new  optional  range of values in pct   The new added fraction will be placed where the right mouse button was pressed     HIGHLIGHT FRACTION  This function highlights certain fraction characteristics by dividing it into several areas  maximum of 3    In this way precise information may be obtained regarding the concentrations of certain pathological  components  e g  monoclonal peaks      CANCEL CHANGES  If you make irreversible mistakes while correcting a graph  for example when correcting its baseline or  deleting an area   it is possible to restore the graph as measured  Click this button to restore the graph  to its original state  
36. ult quality  It is therefore unadvisable to change these settings unless you  are fully aware of what you are doing     Page 27 52       EARE          aR          a  Ls    720 44  aq  Ez  a    ad    Application Line    Filet a Breer    AM nioln  Peele                                   Parameters modification related to tracks editing are shown on this screen     e Application Line   by decreasing this value more points at the end of the track will be displayed    needs membrane re scanning      e Filter Calibrator  allows to change the filter parameter used by the instrument to compensate  variation density of the acetate membrane  default value is 23    Change of this parameter is password protected  PW   device   and should be performed only by  authorized technical service personnel    It is higly reccomended not to modify this parameter unless to be able to prove its correctness by  means of a proper serum calibrator     e Calibration Factors   allows to set a calibration factor for each fraction defined into the exam    Page 28 52             his is a sample Te    RIES ek Eon Ot PETS    Aabi Ume Ete  toe ro Or Eee    it managemet         _  Pri f  md Print Logo O None     Automatic    yd Print Report in Colour    Wil Mark Values out of Range Inactivity time joo  gt           Select the  VARIOUS  button from the  CONFIGURATIONS  menu to edit the printing and  instrument connection parameters     REPORT PRINTOUT CONFIGURATION PARAMETERS     PAGE HEADER   this is the space 
37. y        Remove the acetate supports from the strip racks        Clear the depositor by a soft bristle brush     4 2 ROUTINE MAINTENANCE    It is advisable to wash the following parts more carefully at regular intervals         Migration chamber  fill the chamber  fill it with distilled water and leave it for an hour       Clear the buffer side   Remove the buffer tank and put a tank with a 10  hypochlorite solution  From the Reagents  Menu  click on the buffer  Fill  button and after a couple of seconds press the  Recycle    button        Immerse the serum plate in 10  hypochlorite solution for an hour and rinse with distilled water     Page 33 52    Here must be defined all Samples used for control purpose  It   s possible define one or more samples  for each exam indicating the average value attended for every fraction     When a Control is defined it   s possible to select it by the Q C  dropdown menu into the    List of  Patient    screen           New Control    SIEROPROTEINE                Page 34 52    The first thing to do to properly use the QC management is to select the type of exam from the drop   down  Exam   In this menu we offer exams currently configured in the software  click the mouse on  the exam for which you want to make a QC or where you want to add a new control     By default the software comes with no parameters related  standard  samples  as this is made by  known  sample  for the laboratory or using special kits     New Control    f             Con
    
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