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CEPir User Manual

1. PUMPS CALIBRATION SCREEN 2 OF 2 COMPLETE SETUP AND CALIBRATE Now complete the calibration process as shown below Note that the appearance of the Pump Calibration screen has changed Start Vey 81111 3000 E PWM Pump Calibration Pulses Ed Invalid ml Invalid ml Time NNNNEEEEE mi NEER Current Volume 1008 ml Rate 16 ml per minute To complete the calibration Weigh the empty collection vial Place the collection vial at the end of the tube leading from the Buffer pump Press Start to start the calibration When progress bar shows that the process has ended weigh the collection vial again Subtract the original empty vial weight step 1 above from the vial weight measured in step 4 Dm N eS MR Enter the result of this calculation into the ml data entry area m a mi EN FR Note that clicking on the three dots eee will open an on screen keyboard 7 Press Save Data to save the calibration values Repeat the instructions on the previous page and this page for the Sample pump and the Separation pump 9 When all three pumps are calibrated press Done Fa e an Caution Please be extra careful and as accurate as possible in the pump calibration process Even a small error in calibration can lead to erroneous separation results Fa a Caution Re calibration is required after the CEPir has been switched off 2012 BioCEP Ltd Page 38 BI P User Manual Preparing for a Cell Separation CEPi
2. Pump Buffer Rate 3 mi minVolume 1 ml step 2 8 Demagnetize Pump Separator Rate 3 ml minVolume 5 mi Starts during step 3 Pump buffer after passing 0 5m 4 1 Carousel Select vial number 2 Demagnetize Turn off electromagnetic fields at the four separation units Begin this step only after step 1 above has completed 3 Pump Start the buffer pump at a rate of 3 ml min until 1 ml has been pumped Begin this step only after step 2 above has completed 4 Pump Start the separator pump at a rate of 3 ml min until 5 ml have been pumped Begin this step after step 3 has pumped 0 5 ml of fluid 2012 BioCEP Ltd Page 66 BIOCEP User Manual CEPir Maintenance CEPir HOW TO EDIT THE PROCESSES OF A SEPARATION SCENARIO CHANGING THE VALUES OF PARAMETERS IN A PROCESS FUNCTION Double click on the function process step that you wish to edit or click once and then press Edit You will be presented with a dialog box that shows the parameters available in that process step The parameters and related dialog boxes are shown below Carousel Select a vial Separator Turn on a magnet Activate a pump to the user and wait until he responds on the touch panel 7 2012 BioCEP Ltd Which vial 1 2 or 3 Which magnet Left or right Strength of magnetic field 100mT to 900 mT Which pump Separator Buffer or Sample Rate of pumping 0 5 ml to 10 ml per minute Volume to be
3. Running the Cell Separation EP BIOC User Manual Ga CEPir SCENARIO STATUS EXAMPLE 3 A PUMP DOOR IS ACCIDENTALLY OPEN In this example CEPir is notifying us that a pump door is open 00 06 10 Detected open motor doors Exit Cancel execution of the scenario Log Enter a user comment to the CEPir log file Info Display an on screen legend explaining the icons used on the Scenario Run screen Resume Resume execution of the scenario 2012 BioCEP Ltd Page 48 Running the Cell Separation CEPir Scenario BICEP User Manual SCENARIO STATUS EXAMPLE 4 PERFORMING SEPARATION In this example the separator magnetic fields are in operation and the selected cells are in magnetic Stasis 00 07 47 Log Enter a user comment to the CEPir log file Info Display an on screen legend explaining the icons used on the Scenario Run screen Pause Temporarily pause the scenario operation 2012 BioCEP Ltd Page 49 BIQCEP User Manual Calibration CEPir SCENARIO STATUS EXAMPLE 5 DEGAUSSING In this example the degaussing operation is running 00 07 06 Log Enter a user comment to the CEPir log file Info Display an on screen legend explaining the icons used on the Scenario Run screen Pause Temporarily pause the scenario operation 2012 BioCEP Ltd Page 50 BIQCEP User Manual CEPir 11 DEVICE SHUTDOWN It is recommended to turn off the device at the end o
4. 2012 BioCEP Ltd Page 27 Installing Disposable EP BIOC er BEd Components and Sample mall STEP 6 PLACE THE TUBES IN THE CAROUSEL SEE ITEM 5 ON PAGE 19 Ensure that the end of the yellow connector is placed into the vial STEP 7 LOAD THE PREPARED SAMPLE INTO THE SAMPLE VESSEL SEE ITEM 2 ON PAGE 19 Follow your bead manufacturer s instructions for the sample preparation procedure In order to load the prepared sample depress the red shutter of the Sample vessel until it is fully down load the sample in to the vessel through the red hole using a pipette when finish pull up the red shutter 2012 BioCEP Ltd Page 28 BIQCEP User Manual Preparing for a Cell Separation CEPir 9 PREPARING FOR A CELL SEPARATION After the BioCEP Disposable Kit has been installed and the buffer and sample have been loaded the cell separation process can be initiated Note Software Updates From time to time we will inform you of available software updates These can be downloaded from the BioCEP website www biocep com Installation is per online instructions START THE SOFTWARE AND LOG IN 1 Turn on the system with the ON OFF switch 2 Click on the BioCEP icon The Logon screen will display B OS ed Process Cell Enrichment Process v1 41 Enter your username and password Click on the three dots to display an onscreen keyboard Fi Note First time login If you are logging in for the first time
5. G E EE ed 55 EIOEEP PROMIDED MAINTENANCE sie asse ek Se eed ene ee ie oe be et ee ede n SE ee es oe ie ee EE Ee EE 55 Separation Scenarios on the WoD ise scccceconeteiscncenaseconcoetanarecute nnn E ie ei oo Ee eN 55 Calibration of the Electromagnetic Fields BioCEP Personnel Only ees ees see ee ee ee ee ee 56 2012 BioCEP Ltd Page 5 BI CEP User Manual About this Manual CEPir APPENDIX A SEPARATION SCENARIO GENERATOR cccecscscsccccccccccscscscscccscsccccscscscssssseesees 57 HOW ARE SEPARATION SCENARIOS CREATED sees ee RE DE ME Ee ee ER Oe Ee SR Dee Ee Ge ee Ge Ge ee ee Es ei ee 57 STARTING THE SEPARATION SCENARIO GENERATOR SSG FOR THE FIRST TIME ees sesse ee ee esse see ee ee ee ee ee ee ee ee ee ee ee ee 58 Cicek of EO ee EE ee ee ee Ee ee ee Ee EE ee eer er 58 AE RE EE EE EE N 58 3uEriter User and Password esse GE ee N ee oe GE ER De ge be GR Ke ee Ge GE Gee ee Ge Eg Ene 59 id ie bee lt 9 f g EE OE EE EE OE EE 59 5 Adding Users and Changing PaSSwords sees sees ee ee ee ee RR ee RR ee ee RE ee ee ee Ee ee 60 IMPORTING SEPARATION SCENARIOS dasse Ge eN Se eg se eg const ee Ee ER Ge ig oe eb Oe Ga Ge Ee Ge EG N ie ge N eg ee 61 6 IMmiportine a Scenario ESE ge Eg RE GE De GR Ge Ge eee 61 EDITING SEPARATION SCENARIOS os eon ee NE E Ee Oe RD EG Ge Ge AR 62 OVERVIEW OF THE EDIT SCENARIO SCREEN vs eie ae bees ie gig se eg ee EG Ee ee Ee bee ke Ge ee oge Ge ee 63 TERMS USED IN SEPARATION SCENARIO Scsi
6. O TE Side view showing the power The fully assembled CEPir cord inlet on off switch and fuse housing 1 Dual Separation Units 10 Sample Pump 2 Sample Disposable Unit and 11 Ventilation Opening tubing 12 Sample Vessel handle 3 Buffer Disposable Unit and tubing 13 Mixing Vessel and Separation disposable unit and tubing 4 Buffer Bottle 14 Rear handle 5 Carousel and vials 15 Reset Switch 6 Front handle 16 USB ports 7 Display Screen 17 Fuse assembly 8 Buffer Pump 9 Separation Pump Disposable component of the BioCEP Disposable Kit 2012 BioCEP Ltd Page 18 BIQCEP User Manual System components CEPir DETAILED DESCRIPTIONS OF SYSTEM COMPONENTS A Note Item numbers in blue are references to the diagram on page 18 1 DUAL SEPARATION UNITS Electromagnets that hold the target cells in stasis 2 SAMPLE DISPOSABLE UNIT BIOCEP DISPOSABLE KIT Vessel to hold the sample cells and the tube that will lead them to the mixing chamber 4 BUFFER BOTTLE Standard consumable that contains the liquid buffer Buffer bottle 2012 BioCEP Ltd Page 19 BIQCEP User Manual System components CEPir 5 CAROUSEL The CEPir comes with two carousels one for up to four test tubes of 15 ml and one for up to four test tubes of 50 ml The Carousel Assembly 6 FRONT HANDLE If it necessary to move the device it should be gripped firmly by this handle and by the rear handle 7 DISP
7. DISPOSABLE COMPONENTS sesse skede oes de SEG Ge ER SG Oe OG Ge be ee Ge ge Oe ere di bi eg ee 22 INSTALLING THE BIOCEP DISPOSABLE KIT DISPOSABLE COMPONENTS ese esse sees ee ee ee ee ee ee ede ee ee ee ee ee ee ee ee ee ee ee 23 Step 1 Open the BIOCEP disposable kit esse eed Ee de Ge ee ie ee ed Ed GE ER ee 23 Step 2 Prepare the Buffer and collection Area ees see seek ee ee ee RR ee ee ee RR ee ee Ee ee 23 Step 3 Place the separation disposable unit see item 13 on page 19 esse see ee ee ee Ee 24 Step 3 Continued Place the separation disposable unit see item 13 on page 19 esse ees ee 25 Step 4 Place the Buffer disposable unit see item 3 on page 19 ees see ee ee ee ee ee ee EE 26 Step 5 Place the Sample disposable unit see item 2 on page 19 ee ee ee ee ee ee ee Ee ee 27 Step 6 Place the Tubes in the Carousel see item 5 on page 19 ees see ee ee ee RE ee ee EE 28 Step 7 Load the Prepared Sample into the Sample Vessel see item 2 on page 19 ees ees 28 9 PREPARING FOR A CELL SEPARATION osse sasse ene e ee ee oed eke Su Ge Ge Ke ep ee Ge eg Gods e e aeina 29 START THE SOFTWARE AND LOG ING eien es ese Ge oe ei ee eie we ee GE ee OG ent er ae Goeie Ge die 29 THECEPIRINTACSCREEN OO EE ER EE OO OE EO EE 30 INITIAL SCREEN FOR NORMAL PERMISSIONS LEVEL USER esse sees sees ese ese see ee ee ee ee ee ee ee ee ee RR EE ee ee ee de ee ee ee 31 INITIAL SCREEN FOR ADVANCED PERMISSIONS LEVEL USER esse esse sees ese ee ee ee ee
8. Details hen enter information for the new r l Inen ente ArmA OI ei E NENS Permission can be one of the following values Edit User Regular user This user can run scenarios on CEPir but cannot change scenario Uzer Name New User 1 parameters Password New User 1 Advanced Can also change some protocol parameters igs such as pumping volume and speed PFermissierl admin Can also modify Separation Scenarios Expert Mode Users and User details Can create new scenarios Admin reserved for BioCEP use If expert mode is checked fewer notification messages will be displayed by the system We recommend that you check this box only after you are familiar with the system HHHH User Name and Password Selection Since the CEPir device supports the US English keyboard only use English letters and numbers to define new users and passwords Switch your keyboard to English and type the user name and password If your keyboard does not support English use the on screen virtual English keyboard to type your user name and password Please note that when typing the Scenario Name and Scenario Description you can use your local language which will display correctly on the CEPir screen 2012 BioCEP Ltd Page 60 CEPir BIOCEP User enue CEPir Maintenance IMPORTING SEPARATION SCENARIOS CEPir comes with two predefined Separation Scenarios If you are signed in as an Advanced or Admin user you Can imp
9. Kit is described in detail on page 19 Caution Always check the expiration date prior to using a BioCEP Disposable Kit Caution Do not use if the BioCEP Disposable Kit BioCEP Disposable Kit seal is broken Caution The entire BioCEP Disposable Kit BioCEP Disposable Kit must be discarded after each cell separation It cannot be cleaned or reused Eee Note The Buffer solution is not part of the BioCEP Disposable Kit BioCEP Disposable Kit and may be used in more than one procedure 2012 BioCEP Ltd Page 16 BIQCEP User Manual Overview of System Components CEPir STANDARD CONSUMABLE ITEMS These are off the shelf disposable items and are replaced for each separation Examples of standard disposable items include off the shelf reagents and magnetic beads a buffer liquid agent and the vials used for cell collection Note The CEPir can utilize any of a number of off the shelf reagents and beads Be sure to follow incubation and bead detach protocols for the specific type of reagent in use for best results The CEPir software allows parameter manipulation which can be adjusted per specifications of the beads in use Collection vials Buffer 2012 BioCEP Ltd Page 17 BIQCEP User Manual System components CEPir 7 SYSTEM COMPONENTS The following diagram lists all of the CEPir components O Bottom view of the Display Screen Item 7 r ad _ xy Ss YO 0 YOO o g Go F
10. Manual Run screen 2 Default scenario name for this user The 8 Calibrate pumps and touch screen page 36 default scenario is automatically set to the last scenario selected 9 Administration Edit scenarios page 42 3 Description of the selected scenario 10 Calibration Status e OK Pump is OK 4 System information e Calibrate You must perform pump calibration page 36 prior to proceeding 5 Select a scenario page 35 with separations 6 Run the selected scenario page 46 2012 BioCEP Ltd Page 32 BIQCEP User Manual Preparing for a Cell Separation CEPir INITIAL SCREEN FOR MASTER PERMISSIONS LEVEL USER B 1032 File Zoom Display Tools Help Active User tali Master Buffer Pump 6 Sample Pump 6 Separation Pump 6 Cell Enrichment Process v1 41 1 User information 2 Default scenario name for this user The default scenario is automatically set to the last scenario selected 3 Description of the selected scenario 4 System information 5 Select a scenario page 35 6 Run the selected scenario page 46 2012 BioCEP Ltd 3 14 2012 9 30 AM On 3 14 2012 9 32 AM OK 3 14 2012 9 34 AM OK 7 Open Scenario Manual Run screen 8 Calibrate pumps and touch screen page 36 9 Administration Edit scenarios import export XML files set scenario active inactive page 42 Update firmware page 43 Export log file page 41 10 Calibration Status e OK Pump is OK e Calibrate You must
11. may be set to 1 for all oe scenarios Click on Add kit then enter 1 in the resulting dialog 1 DOX Cancel Edit Scenario x Scenario Name protocol 4 Kit Identification Number Description ho bubble Q Add YE remove Fre pad Priming Proc Component Param 1 Param2 P Add Fill f Fai i ha RR p 1 arousel Vial 1 A kanos my Separation 2Pump Buffer Rate 4 mi minVolume 4 mi Ri MP A es 3 Pump Separator Rate 4 mi minVolume 2 4 ml dj Collecting Down la User Text Check that the Buffer and Caption Down Separator tubes are full with liquid Reset Edit Counters el Dependency Done closes this window Save saves your changes to the scenario Save As saves your changes under a new scenario name Process shows the process Functions shows the steps defined for the detailed actions and Separation Scenario This parameters for each example has five process process This example steps shows has four functions The buttons on the left Add The buttons on the right Remove Up Down allow Add Remove Up gt you to add delete or re Down Edit allow you to order the processes add delete re order or Reset Counters restarts the edit the functions volume indicator when Dependency allows you running the scenario to specify when to start the function 2012 BioCEP Ltd Page 63 BIOCEP
12. pages 2012 BioCEP Ltd Page 30 BIQCEP User Manual Preparing for a Cell Separation CEPir INITIAL SCREEN FOR NORMAL PERMISSIONS LEVEL USER Gm 1432 File Zoom Display Tool Help Active User batel Mor mal auto fill enh rinse Maintenance Calibration Status ec C a Calibration Element Run Count LastTime Status Buffer Pump Sample Pump Separation Pump Cell Enrichment Process v1 41 1 User information 2 Default scenario name for this user The default scenario is automatically set to the last scenario selected 3 Description of the selected scenario 4 System information 5 Select a scenario page 35 2012 BioCEP Ltd 3142012 9 30 AM 142012 9 32 AM A142012 9 34 AM 6 Run the selected scenario page 46 7 Open Scenario Manual Run screen 8 Calibrate pumps and touch screen page 36 9 Calibration Status e OK Pump is OK e Calibrate You must perform pump calibration page 36 prior to proceeding with separations Page 31 BIQCEP User Manual Preparing for a Cell Separation CEPir INITIAL SCREEN FOR ADVANCED PERMISSIONS LEVEL USER 132 File Zoom Display Tools Help 5 4 auto fill reset counters N O O Active User eran Advanced Calibration Status Element Run Count LastTime Status Buffer Pump 3 14 2012 9 30 AM OK sample Pump 3 14 2012 9 32 AM OK Separation Pump 3 14 2012 9 34 AM UFR Cell Enrichment Process v1 41 1 User information 7 Open Scenario
13. scenarios you can export the scenarios to a flash drive The can then be imported from the flash drive into the CEPir device using the touch screen software see page 42 To export the scenarios first ensure that they are marked as Exportable in the list of scenarios on the main screen In order to mark a scenario as exportable right click on the no icon next to the scenario The icon will change to yes Right mouse click Xr 2 Mre When you have marked all of the desired scenarios as exportable you are ready to export them to the flash drive You screen might appear as follows User EP i _ New E Delete BI Ot EE Versior IT A Export LE Import SE Users Scenarios Description Id User Scenario Name Exportable no bubble 1 master protocol 4 yes 2 master protocol 5 Y yes 3 master si X no 2012 BioCEP Ltd Page 69 BIOCEP User Manual CEPir Maintenance CEPir In this example when we click on Export we will export the following information e List of all users always included in the exported data e Protocol No 4 e Protocol No 5 In order to begin the export click on Export A standard Windows dialog box will be displayed 7 Select an output filename iN aa E OOO T tw J biocep Separation Scenario Generator gt v 44 Search Separation Scen P Organize New folder SEE v A A J Downloads Name Date mod
14. use username master password master to login Please start by loading the XML file that includes users and scenarios created with the BiOCEP Scenario Generator software When done logoff and login again using the user credentials as defined with the BioCEP Scenario Generator See Appendix A for instructions 2012 BioCEP Ltd Page 29 BIQCEP User Manual Preparing for a Cell Separation CEPir If you cannot logon press Help A support code will be displayed in orange text near the middle of the screen File Zoom Display Tools Help B IOS ode Process username in Contact BioCep with Code 4254 1091 6736 Help Code EK Cell Enrichment Process v1 41 Contact BioCep with Code 4254 1091 6736 For assistance call BioCEP support and provide the support code THE CEPir INITIAL SCREEN The initial screen that you see is customized to reflect your permission level in the system The capabilities of each permission level are given below Permission Level Capabilities Normal Select Scenario to run Calibrate Pumps Screen Advanced Normal permissions and also Edit Scenario Advanced permissions and also Import Export XML files Set Scenario Active Inactive Update Software Update Firmware Export Log file BioCEP Master permissions and also Manual Scenario Run Calibrate Separators Set degauss voltage set pump properties exit to Windows Each of these initial screens is discussed in the following
15. 12 BioCEP Ltd Page 6 BIQCEP User Manual About this Manual CEPir 1 ABOUT THIS MANUAL This manual provides the information necessary to operate the CEPir in a safe and efficient manner Please read and understand this manual before operating the system If you have any questions please contact customer support WARNINGS CAUTIONS AND NOTES Three types of special messages appear in this User Manual A warning indicates the possibility of general system failure or hazard to health A caution indicates a condition that may lead to incorrect or misleading results A note provides other important information 2012 BioCEP Ltd Page 7 BIOCEP User Manual Safety CEPir 2 SAFETY GENERAL SAFETY INSTRUCTIONS Warning Do not use before reading and understanding this manual Warning Place this user manual in a place accessible to all users for future reference Warning To reduce the risks of electric shock do not remove cover or back of device Warning To reduce the risks of fire or electric shock do not expose the device to rain water splashes or moisture The device is intended for indoor use only Caution Do not block any of the ventilation openings Caution Unplug this device when it will be unused for a long period of time Warning Do not install near any heat source Warning Do not scratch or press with excessive force on the display screen Do not touch the screen with a sharp instrument War
16. 60Hz 600W Fuse 3 5A 250V T N MADE IN ISRAEL BioCEP Ltd Tel 972 4 6828828 Cell Enrichment Process web www biocep com CEPir Cell Enrichment Process Device Device package label This label is found on the MODEL No CEP 01 Gen 1 P N 500001 Ed ale FRAGILE CEPir device package MADE IN ISRAEL B I BioCEP Ltd OGE Tel 972 4 6828828 Cell Enrichment Process web www biocep com BioCEP Disposable Kit FOR SINGLE USE ONLY Disposable kit label This label is found on the P N 500002 STERILE JEO Label No 500006 DO NOT USE IF PACKAGE IS disposable kit Expiration Date MM YYYY DAMAGED OR OPEN YYYYMMDD STORE IN A COOL DRY PLACE MADE IN ISRAEL B BioCEP Ltd OCT Enrichment Process web www biocep com Disposable kit package label This label is found Package of 16 BioCEP Disposable Kits on the package of disposa ble BioCEP kits P N 500004 Label No 500008 LOT YYYYMMDD Expiration Date MM YYYY MADE IN ISRAEL 2012 BioCEP Ltd Page 13 BIOCEP User Manual Labels and Symbols CEPir SYSTEM FEATURES CEPir has the following system features e Silicone tubing protects cell populations e Flow through technology enables high volume separations e Four separation areas ensure high yield e User controlled electromagnetic magnetic field strength and flow rates e Buffer fluid prevents aridity e Depletion and positive separations e Touch screen definition for simplicity of use e Fits under l
17. CEP Ltd Page 15 BIQCEP User Manual Overview of System Components CEPir 6 OVERVIEW OF SYSTEM COMPONENTS CEPir includes components of three types e Fixed components which are used and reused for all procedures e Disposable components specifically the CEP Kit a set of pre packaged disposables provided by BioCEP Ltd which is replaced for each separation that is performed e Consumable components which includes standard off the shelf consumable medical supplies such as reagents vials and physiological buffer Replacement of all disposable components before each separation procedure prevents cross sample contamination and eliminates routine cleaning between separations A brief discussion of these components is given below CEPIR ISOLATION DEVICE The CEPir Isolation Device is the basic hardware and software used for cell separation It includes electromagnetic field generators pumps fluid reservoirs computer touch screen and related software The CEPir Isolation Device is used for all procedures It does not require cleaning or maintenance before each procedure The CEPir Isolation Device is described in detail beginning on page 18 SPECIAL DISPOSABLE ITEMS BIOCEP DISPOSABLE KITS The BioCEP Disposable Kit is a set of three pre packaged disposable items used for cell separation Sample unit Buffer unit Separation unit The BioCEP Disposable Kit is for one time use only and must not be cleaned or re used The
18. EP SCREEN This screen displays when the BioCEP button is pressed on the main screen BioCep Configuration 1 Reset Calibration Configuration 2 Validate Calibration Set Regional Serial Control Task Manager Remote Display Configuration 1 Set Degauss Voltage Pump Max speed and Magnet inactivity timeout Configuration 2 Other BioCEP related settings Reset Calibration Reset the Calibration Run Count and set the Status to OK Validate Calibration Set the Calibration Status to OK Set Regional Configure the Language Currently US English only Task Manager See the running software status Exit OS Exit the CEPir application Serial Control Used by BioCEP technical support for low level non user control and status Remote Display Manage the CEPir from a PC Requires WiFi network access Exit Sentinel Exit in order to change CEPir software version Done Return to the main screen Log View internal messages generated by the CEPir software 2012 BioCEP Ltd Page 44 BIQCEP User Manual Preparing for a Cell Separation CEPir CONFIGURATION SCREEN This screen appears as follows Configuration 1 Voltage Pump Max Rate Buffer Sample Separation Coils time limit 15 i Minutes Voltage Set the default degauss de magnetize voltage Default is 36 V Pump Max Rate Set the maximum rate for each pump Default is 20 ml min Coils time limit Set the overheating protecti
19. EPir performs several operations including priming the pumps with Buffer pumping quantities of buffer and sample into the mixing vessel pumping the resulting mixture past the electromagnetic separation areas and so forth The exact sequence and details of these operations are referred to as a Separation Scenario When you use CEPir you are presented with a dropdown list of the available Separation Scenarios From this list you choose one Separation Scenario to perform the cell separation Note A Personal Computer or Laptop running Windows XP Vista 7 is required to run the Separation Scenario Generator HOW ARE SEPARATION SCENARIOS CREATED The Separation Scenario Generator software application is executed on a PC to create the desired Separation Scenarios Then the CEPir Administrator imports the Separation Scenarios into CEPir so that they will be available in the dropdown list The CEPir Administrator can also manage the list of authorized users This Appendix describes the operation of the Separation Scenario Generator software This process is illustrated below Generate Separation Scenarios n Details on page 58 Run Separation Scenario Generator software One time application O operation by Administrator Separation Scenarios data file Import Scenarios to CEPir n Details on ET One time Import Separation Scenarios data file operation by Administrator TT Additional Separation Scenarios available in dropdow
20. G POWERFUL MAGNETS sesse sesse se ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee 10 3 INTRODUCTION oases octet esse vans Oe Roe ie EG WER GR EG De ae AR Ee ERG ED EE De hee eo ee 11 THE CELL ENRICHMENT PROCESS CEP AN EE N 11 TAE CEPI EE RE ER E N 11 IMMUNO MAGNETIC CELL ISOLATION cccccccccccecececcceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeeeeeeeeeeeeess 11 FLOW THROUGH CONTACT FREE ISOLATION sssssssssesesereeeeeeesrereeseerereeeerereeeereeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeereeees 12 FOUR ISOLATION AREAS AND ELECTROMAGNETIC TECHNOLOGY esse sesse ees ee ee ee ee 12 OTAR INGINI T io ee se saree sam vAN EE ee Ge AO ee ve SE AO ee Se AO ee ee Eg 12 4A LABELSAND SYMBOLS oats eed Steek ee ee eN Gee ee ime wee eo be oe Eend AE Ee Ge EE ke EE Ee Gee 13 Ed RE EE 13 SVOTE Fe VS EE OE EE N EE EE EER 14 5 SYSTEM INSTALLA TION sesse sis ese ede eN SEGE de NR ME EE ee Ee HE GES doe N ERG ee Ao AO oe ee EE 15 CONNECTING TE SYSTEM COMPONENTS es ea ee Re Ee ee ee RR ee ee ee ee ee 15 PANE asaitsble lo OR ee EE ER De GE ee re Ge GE OE EE de ee 15 Connecting the boel supply ae de EE 15 6 OVERVIEW OF SYSTEM COMPONENTS sees REG GE ER See n Ge Go SE Re ERG EG Ee ee We ee OE Ge Reed RE die 16 CEPIF SORA TIO IIE CE asses ee sues RE seve Ge RE seve R 16 SPECIAL DISPOSABLE ITEMS BIOCEP DISPOSABLE KITS sesse sesse ee ee ee ee ee ee ee ee ee ee ee ee ee ee 16 STANDARD CONSUMABLE ITEMS sd n eo Go Ee Ge ee i
21. LAY SCREEN The display screen is a touch sensitive device A user friendly graphical user interface GUI guides the user through the process The GUI is described on page 29 8 BUFFER PUMP The Buffer Pump is one of three peristaltic pumps used in the device It gently draws the buffer solution from the Buffer bottle to the mixing chamber 9 SEPARATION PUMP Draws from the mixing vessel through the user controlled electromagnetic fields and four separation areas 10 SAMPLE PUMP Draws the sample from the sample vessel into the mixing chamber 11 VENTILATION OPENING Take care not to block this opening 12 SAMPLE VESSEL ANGLE HANDLE The lower position of this part is to be used in a laminar hood see next page 13 SEPARATION DISPOSABLE UNIT MIXING CHAMBER This is the mixing vessel where the buffer solution and the sample are mixed in preparation for target cell separation 2012 BioCEP Ltd Page 20 BIOCEP User Manual System components CEPir 14 REAR HANDLE Use this handle and the front handle see item 6 in the diagram on page 18 to move or carry the device 15 RESET SWITCH In the event of a device malfunction you may push Reset to restart the machine 16 USB PORTS For connecting a keyboard or a disk on key WORKING UNDER A LABORATORY HOOD Working under a hood allows isolations in a sterile environment Isolations performed under a hood are performed in the same manner as re
22. N SCENARIOS A Separation Scenario specifies the detailed steps of buffer and sample pumping speeds and volumes magnetic field strengths waiting periods and other parameters for cell separation Your CEPir comes with two preinstalled Separation Scenarios e Scenario 11 Basic isolation scenario e Scenario 12 Basic isolation scenario with intense rinse mode Scenarios can be edited and created using the PC based Scenario Protocol Generator which is described on page 57 Additional scenarios are available for downloading at BioCEP s website www biocep com See page 55 for more information on downloading separation scenarios Two screens in the CEPir touch screen GUI are used in connection with scenarios e CEP Scenarios Management screen see page 42 o Import export and edit scenarios o Not available for Normal level permissions user limited to Edit capability for Advanced level users e Select Scenario screen described below o Choose a scenario to use when you run the separation process CHOOSE AND RUN THE SEPARATION SCENARIO Choose the working scenario by pressing Select from the main screen The Select Scenario screen will display Select Scenario no bubble bubble in washing changing magnetic fields separation in 9 fractions Click on the name of a scenario and press Select This will return you to the main screen Then click Run to run the scenario Click Cancel to return to the main screen without cho
23. P technology utilizes a flow through contact free approach The flow through approach allows the gentle passage of the specimen through the isolation areas The negative fraction flows through the disposable silicon tubing and out of the system while the tagged cells are held in stasis within a buffer fluid in any of the four isolation areas The cells do not aggregate on any metallic medium on the tubing or on each other This novel design is the key to the high viability of CEP isolated cells FOUR ISOLATION AREAS AND ELECTROMAGNETIC TECHNOLOGY The CEPir offers four separate isolation areas through which the cells pass during the isolation process These numerous isolation areas enable excellent recovery rates with only a single pass and enable rare cell isolation of 1 in 10 The unique electromagnets enable customization of magnetic field strength to suit your isolation needs STARTING KIT Your CEPir comes with a specialized starting kit the CEPir Disposable Kit Isolations with the device require off the shelf reagents beads and buffer 2012 BioCEP Ltd Page 12 BIQCEP User Manual Labels and Symbols CEPir 4 LABELS AND SYMBOLS LABELS B I BioCEP Ltd OGE Tel 972 4 6828828 Cell Enrichment Process web www biocep com CEPir Cell Enrichment Process Device Device label This label is found near the power MODEL No CEP 01 Gen 1 PIN 500001 inlet at the back of the device S N 2012XXXXXX POWER 100 240V 50
24. SPOSABLE KIT STEP 2 PREPARE THE BUFFER AND COLLECTION AREA 1 Open and remove the buffer bottle cap and replace it with cap from the BioCEP disposable kit 2 Place the Buffer bottle in the device see item 4 on page 19 3 Be sure to open the right plug as shown in the diagram in preparation for inserting the tube 2012 BioCEP Ltd Page 23 Installing Disposable Components and Sample BIQCEP User Manual CEPir STEP 3 PLACE THE SEPARATION DISPOSABLE UNIT SEE ITEM 13 ON PAGE 19 1 Place the mixing vessel in its place making sure that it is secured in the omega vessel holder Ensure that the Orientation Tongue is positioned as shown in the figure You should hear a click when the mixing vessel is in place 2 Open the Separation Pump door see r item 9 on page 19 the yellow pump ay Open 2012 BioCEP Ltd Page 24 BIOCEP TT Installing Disposable CEPi Components and Sample r STEP 3 CONTINUED PLACE THE SEPARATION DISPOSABLE UNIT SEE ITEM 13 ON PAGE 19 3 Place the yellow Pump Key and Close A close the pump door Ensure that the kl id Pump tubing is in the correct path and is Door not pinched when closing the pump door 4 Before positioning the tubing place the 90 connector at the hole in the end of the rail 5 Place the tube through the four separation units 2012 BioCEP Ltd Page 25 Installing Disposable EP BOG Boe Com
25. User Guide CEPir Cell Enrichment Process for Isolation of Rare Cells QU Enrichment Process BIOCEP User Manual About this Manual CEPir Manual Number 100011 Text Revised March 2012 Pd Note The information in this document is BioCep Ltd proprietary It is provided to customers and authorized representatives of BIOCEP LTD only Copyright BioCep Ltd 2012 This document may not be copied by any means including electronic mechanical photocopying recording or otherwise without the prior written consent of BioCEP Ltd Unless otherwise indicated the BioCEP system is for research use only CONTACT INFORMATION Customer satisfaction is a BIOCEP LTD priority To help us in providing you with the best possible product and support please send us your comments and suggestions BioCEP Ltd Rebecca Sieff Medical Center P O B 1008 Safed 13100 Israel Tel 972 4 6828828 7 Fax 972 4 6923753 Email info biocep com support biocep com Web www biocep com 2012 BioCEP Ltd Page 2 BIOCEP User Manual About this Manual CEPir TABLE OF CONTENTS 1 ABOUT THIS MANUAL sestig see ee ee Ee ee Ee oe se eo ede doe ee n ge ie do ae ee EE ER ed n Ee Ge 7 WARNINGS CAUTIONS AND NOTES sesse ss a nenne EEEE REEERE REEERE SEERE EEEE E EE EREE EEEn Ennens a nennen anneanne 7 2 SAFETY e E E EE RE E 8 GENERAL SAFETY INS WRU CIOS ass sies ee de oes ees EE Ge Ee ee ie ee rris 8 SPECIAL SAFETY INSTRUCTIONS FOR HANDLIN
26. User Manual CEPir Maintenance CEPir TERMS USED IN SEPARATION SCENARIOS A process is a complete stage of the separation such as rinsing buffer through the system or separating the target cells A process is composed of one or more functions A function is one of the actions of a process such as pumping fluid from the buffer A function may have parameters A parameter is an operational detail of a function such as the flow rate for a Pump function or the message to be displayed for a User function Timing and dependencies determine when a process starts and stops THE FIVE BASIC SEPARATION SCENARIO PROCESSES A Separation Scenario can consist of any combination of the five basic processes as shown below Priming Set up the collection vial and pump buffer fluid into the buffer and separator tubes Fil Fill the mixing vessel with buffer fluid Separation Activate the electromagnets in the separation areas Pump sample into the mixing vessel and pump the contents of the mixing vessel past the separation areas At this point the desired cells will be in stasis near the separation areas The undesired cells will exit into a collection vial Pump additional buffer fluid through the separation areas This will remove any unwanted sample that may have still been in the separation areas Collecting Demagnetize the separation areas The target cells will now be released from stasis Flush the target cells from the system into a collec
27. ab hoods e Two preset scenarios e Isolation scenario definition and customization option e isolation of up to 1 in 10 tagged cells e Isolates 1 50 ml of specimen e Support for most bead types and sizes 2012 BioCEP Ltd Page 14 BIOCEP User Manual System Installation CEPir 5 SYSTEM INSTALLATION CONNECTING THE SYSTEM COMPONENTS FINDING A SUITABLE LOCATION In order to place the CEPir in an appropriate location please note the following e Place the CEPir ona flat hard and stable surface Do not position the CEPir on top of other equipment e Install the unit near an AC outlet and where the AC power plug can be easily reached e Place the device in a location with adequate ventilation to prevent internal heat buildup Do not block the ventilation opening see item 11 on page 18 In addition please ensure that the following items are located near the CEPir e A cabinet for CEPir disposable kits storage e A Biohazard waste can e An analytical laboratory scale A Note Some beads require refrigeration CONNECTING THE POWER SUPPLY Please perform the following steps Connect the power cable to the AC input voltage connector The CEPir has an auto range power supply for input voltage 100 240 VAC Connect the power cord to the wall plug and assure that all cables and connectors are properly connected Switch the unit on Power cable and on off switch item 17 on page 18 2012 Bio
28. agement screen page 43 Set Date Time Change the time zone date and time CEP Upgrade Place a USB disk on key with the CEPir software update file in the USB connection under the screen then press this button Follow the on screen instructions to update the software Export Log Save the system log to an external log file page 41 Log View internal messages generated by the CEPir software Done Return to the main screen 2012 BioCEP Ltd Page 41 BIOCEP User Manual Preparing for a Cell Separation CEPir THE CEP SCENARIOS MANAGEMENT SCREEN This screen allow you to import and export scenarios from the system change which scenarios are available to the user and edit scenarios Scenarios Managment Load XML Save XML Name Active Author Notes 54 Yes no fill 5 4 auto fiill 0 5m rate Yes no fill 5 4 auto fill reset counters Yes auto fill 5 4 auto fill rate 2mi sec No no fill 5 4 auto fillrenh collecting Yes auto fill 5 4 fast rinse Yes auto fill 5 4 fixed No no fill 5 4 fixed 0 5m Yes no fill 5 4 fixed 30 ml sample Yes no fill Yes no fill Done rr Load XML Import a scenario file into CEPir Save XML Export an edited scenario file for later use in the Separation Scenario Generator program on the PC Edit Make changes to the selected scenario Toggle Active Enable disable Normal and Advanced users from having access to a scenario Log View internal messages generated by th
29. and efficient separation with outstanding results The unique contact free design ensures non damaged cell populations and exemplary separation capabilities The CEP s flow through technology and four electromagnetic fields offer endless separation scenario alternatives and rare cell separation capabilities Silicone tubing and buffer fluid ensure high viability of target cells suitable for downstream processes THE CEPIR The CEPir incorporates the patented CEP technology for research and development purposes The CEPir is a bench top cell separator which can fit under a hood for sterile isolations Each isolation requires a CEPir disposable kit The CEPir can process up to 10 tagged cells and can handle specimen volumes of 0 5 50 mL The CEPir comes with two preset isolation scenarios and includes an easy to use software system for infinite isolation scenario creation and a touch screen input mechanism The CEPir IMMUNO MAGNETIC CELL ISOLATION The CEPir enables positive isolation of tagged cells or depletion based on immuno magnetic cell isolation principles Prior to utilizing the CEPir the target cells must be tagged with the relevant reagents and magnetic beads as is commonly acceptable in this discipline The CEPir separates cells tagged with any of a number of off the shelf reagents and magnetic beads 2012 BioCEP Ltd Page 11 BI CEP User Manual Introduction CEPir FLOW THROUGH CONTACT FREE ISOLATION The CE
30. ario contains incorrect separation unit parameters Scenario contains incorrect separation unit parameters Buffer level too low Scenario contains incorrect pump parameters Review the scenario and change parameters if required Review the scenario and change parameters if required Add more buffer solution to buffer bottle Review the scenario and change parameters if required Page 52 BIOCEP User Manual Troubleshooting CEPir Condition Probable Cause Recommended Action Run Scenario does not Pump door is open Close pump door start the scenario Communication problem in unit Check that the communication cable is securely attached to the screen Unit firmware not loaded Check that the firmware version number is displayed in main screen will display Version HxSy Select Program CEP and make sure the firmware is loaded correctly will display Version HxSy Cannot edit scenario User does not have permission Check the user permissions If parameters to edit scenario required change user permissions to permit parameter editing J Note When contacting BioCEP for support please provide the device log file Administrator permissions required and the scenario XML file used 2012 BioCEP Ltd Page 53 BI P User Manual CEPir Maintenance CEPir 13 CEPir MAINTENANCE Because a new disposable Kit is used for each cell separation CEPir does not require frequent user maintenance This se
31. bei ego se veg ee Ee Ee oe ee SG Ge Ge DR EG EN Sie ge ie dv ee 64 THE FIVE BASIC SEPARATION SCENARIO PROCESSES ie sees ies se EG Ge Sa ee SEG N EN We ge OU EG Ne Ee ve Ne EG gee Sie 64 Processes and Related FUNCTIONS c ccccccccccssessssececcccssaeeesseeccecessaueussececccessseuusseeceeeesseueuseeeeeseeenaaas 64 Action and P AARNE ENS ei EDE EE EE la ve Pe eri de erect eran en iN 65 EXAMPLE DETAILED EXPLANATION OFA PROCESS es eiersel nee gee ee oe Ge ee Ge os Ee eg se Oe n Gn Ge oe GE Ok ee 66 HOW TO EDIT THE PROCESSES OF A SEPARATION SCENARIO essens ese N See ees EG N ER ee SR eb Gee NG Ee Ke Ne EG gee 67 Changing the values of parameters in a process FUNCTION cceccceeecccesececeneceeenseceeececeueceeeueeeeeneeeeens 67 Changing the Timing and Dependencies of a Process Step ss esse ee dee dee ee ee ee 68 SAVING A SEPARATION SCENARIO AND USING IT IN A CEPIR CELL SEPARATION ees ees sees see ees ee ee ee ee ee ee ee ee ee ee 69 Savine the CuUrrent Scena Es RE Ee ee Ee Ee RE ee 69 Export th Scenarios toa Hash Drive se ES ER DE Ee DR RE Ge GE EE ee Ge ER ee ee EE 69 SHUTTING DOWN THE SEPARATION SCENARIO GENERATOR ees see ees ee ee ss ee ee se ee ee see ees see ee see ee see ee Es ee ee De ee ee see ee ee 70 APPENDIX B SPECIFICATION Soos soes es de ees oe de oe Ge Ese GOS ee eN GO ele Ee ee de Go ER ee Ge ee 71 APPENDIX C WARRANTY i s ese se es ed ee oe ed ewe ee OG ER Ge N Re GE Ee ie Ge LG N RO ee Ge ed we ed de 72 20
32. contain powerful electromagnets Observe the following related warnings and cautions when using CEPir go Separation units Warning Pacemaker Magnets can affect the functioning of pacemakers and implanted heart defibrillators e A pacemaker can switch into test mode and cause illness e A heart defibrillator may stop working If you wear these devices keep a sufficient distance from the magnetic separators Caution Magnetic field Magnets produce a far reaching strong magnetic field They can damage electronic devices and other items including laptops computer hard drives credit and ATM cards data storage media mechanical watches hearing aids and speakers Warning Influence on people According to the current level of knowledge magnetic fields of permanent magnets do not have a measurable positive or negative influence on people It is unlikely that permanent magnets constitute a health risk but it cannot be ruled out entirely For your personal safety avoid constant contact with the electromagnetic fields near the separation units 2012 BioCEP Ltd Page 10 BIOCEP User Manual Introduction CEPir 3 INTRODUCTION Congratulations on your newly acquired CEPir the most advanced and flexible immuno magnetic cell isolation system THE CELL ENRICHMENT PROCESS CEP The Cell Enrichment Process is a novel design in immuno magnetic cell isolation The CEP s flow through design enables quick
33. ction describes the small amount of maintenance that is performed by the user and by BioCEP Caution Do not open the device There are no user serviceable parts inside Opening the device may void your warranty and service agreements USER MAINTENANCE GENERAL CARE In case liquid is spilled on one of the CEPir surfaces simply dry the surface with a plain paper towel and dispose of the towel properly CALIBRATION OF THE PUMPS BY THE USER Calibration of the pumps consists of testing the pumps for correct volume and speed of pumping When the device is initially installed by BioCEP personnel calibrations of the pumps will be performed If a pump recalibration is required the device will display Calibrate in the Calibration Status section of the initial CEPir screen page 31 and a popup message will appear 3 18 2012 9 29 AM 3 18 2012 9 30 AM 3 18 2012 9 33 AM Pump calibration is performed via the Calibration button of this screen 2012 BioCEP Ltd Page 54 BIOCEP User Manual CEPir Maintenance CEPir CALIBRATION OF THE TOUCH PANEL BY THE USER The touch panel is pre calibrated If recalibration is required use the Calibration option of the main screen of the CEPir touch screen GUI page 31 FUSE REPLACEMENT In the event of an electrical surge or other problem with the main AC current it may be necessary to replace the fuse If you wish to replace the fuse proceed as follows 1 Locate the 1 fuse housin
34. e CEPir software Done Return to the main screen ah Note Only Master and Administrator users can remove scenarios A scenario must have Active status of No to be eligible for removal 2012 BioCEP Ltd Page 42 BIQCEP User Manual Preparing for a Cell Separation CEPir THE FIRMWARE IMAGE MANAGEMENT SCREEN This screen is used when the device s firmware must be changed Hardware Image Managment 26 2 27 2012 22581 BIOCEP2_2012Feb27_H8S26 rbf 25 22 16 2012 225295 BIOCEP2_ 2012Feb16_H8S25 rbf Add HW Image Choose a hardware image file and add it to the list of available images Delete HW Image Remove the selected hardware image from the list Automatic If Automatic is displayed here then the hardware image mode is set to Automatic This means that CEPir will automatically use the hardware image file with the highest software version number the next time the device is started Clear Default Clear the selected file from being the default hardware image The hardware image mode will be set to Automatic Set Default Set the selected hardware image file to the default The next time the device is started the selected file will be used Done Return to the main screen Log View internal messages generated by the CEPir software A Note Only Master and Administrator users can delete hardware image 2012 BioCEP Ltd Page 43 BIQCEP User Manual Preparing for a Cell Separation CEPir BIOC
35. ee ee ee ee ee ee ede ee ee ee ee ee ed ee ee ee 32 INITIAL SCREEN FOR MASTER PERMISSIONS LEVEL USER esse sees esse ese ee se ee ee ee ee dee ee ee ee ee ee ee ee ee ee de de ee ee 33 2012 BioCEP Ltd Page 4 BI CEP User Manual About this Manual CEPir INITIAL SCREEN FOR BIOCEP PERMISSIONS LEVEL USER uses esse sees ees ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ede EE ee ee ee ee RE Ee 34 EAR TION SCENARIOS 2 ee sect ao E 35 CHOOSE AND RUN THE SEPARATION SCENARIO see see ese ene Ge we EE ee ee Ee ER Ee Se Ste EE ee RS se be ee 35 Ee EE EE ER EE N ER EE EE N 36 PUMPS CALIBRATION SCREEN 1 OF 2 FILL TUBING WITH BUFFER FLUID esse ees sees sees sees sees sees se ees ee ee ee ee ee ee ee ee 37 PUMPS CALIBRATION SCREEN 2 OF 2 COMPLETE SETUP AND CALIBRATE esse esse esse ees sees ee ee sees ee ees ee ee ge dee ee ee ee ee 38 MAGNETIC SEPARATORS CALIBRATION es ees ete ED Re N EER SE GR NR EE Ee Ee EE ee RE Ee Se OE 39 TOUCH SCREEN EALIG RANG ae EG Ee ee ER GER ee GE ee EE GE OE ee HE GE Oe DE 40 TEE ADMIN HA WON SCREEN oes ei oe Ee ee sane semen ee Ee EE Re DE ER DE EE Ie Re ee GE Ie SE A1 THE CEP SCENARIOS MANAGEMENT SCREEN sees ese ee ee EE see ee ee Nee is ee RD ere ges ee Ee ese Dee EE ER EED 42 THE FIRMWARE IMAGE MANAGEMENT SCREEN ccssctseuveressmcessedt vas Ge SG gese Ene sae oe vets Ee Re Se Se ee heb be se ed ee ee ke Ee Se 43 BIOGEP SEREEN 2 oa eo eee er ee eee ee ee OE ee ee 44 EONFIGHRASION S ORF EN ies ee De
36. ee te eee Coats oe oe eN een scare sence se AG Ee GE EE meses Oe EG ER ee ee Ee OER EE Ee 45 10 RUNNING THE CELL SEPARATION SCENARIO scscscscscscscsccccccccscscscscscccsccscscscscsascecsccssscscsssaes 46 SCENARIO STATUS EXAMPLE 1 BEGINNING OF SCENARIO sies mees ies sees ee see Godt gie esse ee Ds vic oe ed De be se eine see ee 46 SCENARIO STATUS EXAMPLE 2 PAUSED SCENARIO eo ees ies ee os Gees vend ese dav ee ee Oe ie oe Ee Gee Gis See see ie ie 47 SCENARIO STATUS EXAMPLE 3 A PUMP DOOR IS ACCIDENTALLY OPEN ese esse es sees sees se ees se ees ee ee dee ee ee ee ee ee 48 SCENARIO STATUS EXAMPLE 4 PERFORMING SEPARATION esse esse ee se ees se ees ee ee ee ee sees ee ee ee ee dee dee ee ee ee ee 49 SCENARIO STATUS EXAMPLE 5 DEGAUSSING asie see es ER Se Ee ee Ge ee Ie DO ee Ge oe GE EE 50 11 DEVICE SHUTDOWN assessors ee eie Ge Dee GE GE Ee Ge Ve Ge Ee ed Ge De ND GE Wee EE N Ge Ge Pe dd GE SG N We Ee 51 12 TROUBLESHOOTING sis eds dese ee Ee GEN Ge NG Ge ERG Ge Ee Oe GE Ge We Ee Ge Ee NG Ge GE ee N Ee Ke Ee KG GE ep Ge 52 13 CEPIR MAINTENANCE ees se ee Ge Ge Ge Ge GO Ge Ge ee De Dee Ge GR Ge Ge oi Ge ee 54 di AN N ie N EE N EE EE 54 EE Ore g SE ER ED EE EO EE EE N N 54 Calibration of the Pumps by the USer ccccccssseccccsseccccessccecaesececeuececeeecceseesecessuneceeseneceeseusesetsuneses 54 Calibration of the Touch Panel by the USeF esse ees seek ee ee ee RE ee RR ee ee RE ee RR ee ee Ee ee 55 RUS FED ACS NEN E sso
37. f each day The system shutdown procedure consists of the following steps e Log off from the system e Switch off the device power a Caution Before switching the device off make sure all disposable kit parts are removed from the device and that the pump doors are closed 2012 BioCEP Ltd Page 51 Troubleshooting CEPir BIOCEP User Manual 12 TROUBLESHOOTING Probable Cause Recommended Action Unexpected undocumented Contact BioCEP Ltd error Check that both ends of the outlet power cable are securely attached Unit does not switch on Unit is not plugged into power Power outlet not working Check that the power outlet is switched on Check power outlet with another working device Unit screen is black Unit is switched off Check that the power switch is in the on position and that the green LED above the screen is On Check that the 12 V power cable connected to the screen is Screen power plug disconnected securely plugged into its socket Add more buffer solution to buffer bottle Unpinch the tube Ensure that the pump door is Liquid not flowing in tubes Buffer level too low Tube is pinched Pump door is not latched closed closed properly Scenario contains incorrect Review the scenario and change pump parameters parameters if required Beads not captured by separation magnets Beads not released by separation magnets Unwanted air bubble in tube 2012 BioCEP Ltd Scen
38. g 2 on off switch and 3 power cord inlet on the side of the device 2 Unplug the power cord from both the wall socket and the device itself 3 Release the fuse cover The black switch will 5 Replace both fuses Note Always replace both fuses Always use the same fuse brand and type The fuse specifications are 3 5 amp and 250 V T time lag BIOCEP PROVIDED MAINTENANCE SEPARATION SCENARIOS ON THE WEB BioCEP publishes additional separation scenarios and software updates on BioCEP s web site www biocep com Periodically check this site for updates If available please follow the instruction provided with the update As part of your on going service and support agreement your BioCEP technician will provide other calibration software updates and other yearly activities 2012 BioCEP Ltd Page 55 BIOCEP User Manual CEPir Maintenance CEPir CALIBRATION OF THE ELECTROMAGNETIC FIELDS BIOCEP PERSONNEL ONLY Calibration of the electromagnetic fields consists of checking for correct field strength at the four separation sites When the device is initially installed by BioCEP personnel calibration of the electromagnetic fields will be performed Should a need arise for further calibration the calibration will be performed by BioCEP personnel only 2012 BioCEP Ltd Page 56 BIQCEP User Mandal CEPir Maintenance CEPir APPENDIX A SEPARATION SCENARIO GENERATOR During the cell separation process C
39. gular isolations The system includes an adjustable sample handle see item 12 in the diagram on page 18 which allows easy access to the sample disposable unit for simple sample loading within the hood 2012 BioCEP Ltd Page 21 Installing Disposable CEPi Components and Sample BIQCEP User Manual 8 INSTALLING DISPOSABLE COMPONENTS AND SAMPLE LOCATION OF THE DISPOSABLE COMPONENTS The following diagram illustrates the CEPir when it is fully prepared for a cell separation procedure The disposable items are highlighted in the diagram CEPir highlighting the disposable components 2 Sample Disposable Unit and tubing 5 Vials 3 Buffer Disposable Unit and tubing 13 Mixing Vessel and Separation disposable unit and tubing 4 Buffer bottle Disposable component of the BioCEP Disposable Kit A Note The numbers used here refer to the main diagram on page 19 As part of the separation procedure the BioCEP Disposable Kit must be installed onto the CEPir The detailed installation steps are given on the following pages 2012 BioCEP Ltd Page 22 Installing Disposable CEPi Components and Sample BIQCEP User Manual INSTALLING THE BIOCEP DISPOSABLE KIT DISPOSABLE COMPONENTS AN Caution Before using the Kit check that its factory seal is intact and that the expiration date has not been reached AN Caution Always use protective latex gloves when handling items in the Kit STEP 1 OPEN THE BIOCEP DI
40. ified Type ak Recent Places L saldrivers 02 Feb 12 9 42 AM File folder J 21 BioCep exp Lxml 02 Feb 12 9 55 AM XML File exp 2 xml 02 Feb 12 9 57 AM XMLFile exp3 xml 02 Feb 12 10 08 A XML File protocol No 4 xml 29 Jan 12 9 55 PM XML File protocol No 5 xml 29 Jan 12 9 55 PM XML File 7 Libraries 4 Documents Music Pictures 4 Videos v E TT b File name Save as type XML files xml v Hide Folders Cancel You will typically wish to navigate to a directory in a flash drive so that you may easily transport the exported data to the CEPir In this example we are naming the output file my_scenarios xml SHUTTING DOWN THE SEPARATION SCENARIO GENERATOR In order to shut down the program just click on the standard Windows X in the upper right hand corner 2012 BioCEP Ltd Page 70 BICyCEP User Manual CEPir Maintenance CEPir APPENDIX B SPECIFICATIONS Size HxWxD in cm 55x56x39 Power AC100v 240v 50 60Hz 600W Operating Temp 5 40 C Operating Altitude Maximum of 2000 m EMI EN 61326 1 06 FCC CFR 47 Part 15 Sub B ICES 003 04 2012 BioCEP Ltd Page 71 BIQCEP User Manual CEPir Maintenance CEPir APPENDIX C WARRANTY In addition to the below BioCEP s warranty the Warranty with respect to BioCEP s product the Product is subject to the terms and conditions of sale of this product BioCEP warrants that the Product will be free fro
41. m O type Carrousel action num 1 type Pump action num 2 type Pump action num 3 type User X Click OK to continue 2012 BioCEP Ltd Page 61 BIOCEP User Manual CEPir Maintenance CEPir EDITING SEPARATION SCENARIOS From the list of separation scenarios shown on the main screen double click to edit or view a scenario A Note Not all users can edit the separation scenarios The list of user permissions is on page Frror Raakmark nat dafinad Separation Scenario Generator D Delete AO EP master delete Cell Enrichment Process Version EER Export LE Import b Users Double click on the Scenarios Description scenario that you Ib User Scenario Name Exportable no bubble wish to view or edit 1 master protocol 4 protocol 5 sl Details of the scenario will display on the Edit Scenario screen An overview of this screen is shown on the next page 2012 BioCEP Ltd Page 62 BIOCEP User Manual CEPir Maintenance CEPir OVERVIEW OF THE EDIT SCENARIO SCREEN This diagram shows an overview of the main sections of the Edit Scenario screen The next page shows more details of the scenario editing procedure One or more Kit identification numbers for future use The Kit ID identifies which models of the disposable kit are required for this scenario Name and description of the For the current version of the system le x scenario this number
42. m material defects in materials and workmanship encountered during ordinary use of the product as described in this user manual The Warranty shall not cover Product issues not arising out of defects in materials and workmanship encountered during ordinary use of the Product including but not limited to Product issues resulting from failure to follow installation operating and or maintenance instructions or environmental conditions prescribed in this user manual misuse abuse neglect unauthorized or improperly performed maintenance or repairs accidents acts of god limitations of technology electrical current fluctuations modification of or to any part of the Product use of accessories spare parts and or consumables other than those recommended by BioCEP in this user manual or normal wear and tear BioCEP does not warrant that the operation of Product or the Product software will be uninterrupted or error free or that all Product software defects can be corrected The Warranty does not cover Products which had its serial number defaced altered or removed or any consumables or parts identified as sold by third parties BioCEP makes no warranties express or implied written or oral by operation of law or otherwise of any products or services furnished under or in connection with the user manual BioCEP shall be obligated to honor the express warranties set forth in this user manual only upon BioCEP s receipt of full payment for the Produc
43. n list Perform Cell Separation n Details on page 35 Fan Repeating I operation by Choose and Run Separation Scenario Users from enhanced dropdown list 2012 BioCEP Ltd Page 57 BIOCEP User Manual CEPir Maintenance CEPir STARTING THE SEPARATION SCENARIO GENERATOR SSG FOR THE FIRST TIME 1 CLICK ON ICON On the PC desktop double click on the Separation Scenario Generator icon eS Separation The SSG application will now begin Scenario Generator When SSG is run for the first time this dialog box displays A master user was created for you user name master password master For security reasons please change these settings as soon as possible This indicates that the initial user password of master master has been automatically created 2 LOG IN The login screen displays reduesting your user and password E Separation Scenario Generator EP B Do OL Enrichment Process Versior FEE Scenarios es Id User Scenario Name Exportable 2012 BioCEP Ltd Page 58 BIOCEP User Manual CEPir Maintenance CEPir 3 ENTER USER AND PASSWORD Click on User to enter your initial user and password of master and master Select user Name master Password EELEE 4 LIST OF SCENARIOS After logging in you will see the main screen updated with a list of available scenarios Here is an example of the screen when signed on as user master Sepa
44. nce Step 3 is These are Dependencies Li p xX A Define dependencies between procedures p dek E to steps in this step 4 Pump separator Starts during will be pumped by Step 3 HOSEL ii eee Ee before we begin Step 4 Note that step 2 Demagnetize afte ml Step 3 the step 3 Pump buffer a immediately derd 9 n step is the same time as Step 3 selected Starts after completion of Click here to start Step 4 after the completion of Step 3 This is the default situation 2012 BioCEP Ltd Page 68 BIOCEP User Manual CEPir Maintenance CEPir SAVING A SEPARATION SCENARIO AND USING IT IN A CEPIR CELL SEPARATION When you have completed your editing of a separation scenario you are ready to save your changes When all scenarios have been created or edited you can export them to a flash drive for use in CEPir SAVING THE CURRENT SCENARIO l wa scen al X Click Save to make permanent the changes that you have made to the Ed Scena scenario If you wish to copy the changes to a new scenario click on Save As Enter scenario name and enter the new scenario s name o aa When you have made and saved all of your changes click Done Edit Scenario Scenario Name protocol 4 Kit Identification Number Description ho bubble C ria aP EXPORT THE SCENARIOS TO A FLASH DRIVE After you have added or updated all
45. ning The CEPir is equipped with a three wire electrical grounded type plug that fits only into a grounded power outlet Do not try to insert the plug into a non grounded power outlet Warning Plug the unit into a properly installed power outlet of the appropriate voltage Ensure that the power cord is not bent or pinched Warning Do not operate with a damaged cord or plug If a cord or plug is damaged have the cord or plug replaced immediately by a qualified service technician Caution Use only with attachments accessories specified by the manufacturer Caution In order to reduce the possibility of damage to the device place on a strong table or other firm surface Warning If the apparatus emits smoke or an odor immediately disconnect the power cord from the wall outlet Wait until the smoke or odor stops before touching the apparatus Call your BioCEP representative for inspection and repair Never attempt to service this product yourself Warning If the CEPir is not working properly follow any instructions which may appear gt PPPRPRP EEEE on the screen If the device is not working properly but no message appears or if a message appears to service the device contact your BioCEP representative 2012 BioCEP Ltd Page 8 BI CEP User Manual Safety CEPir Caution Before moving the CEPir turn off the power via the ON OFF switch and unplug 3 the AC power cord from the power outlet When lifting the CEP be sure
46. o Ee GE GR Ee GE Ee ee Ge 17 7 SYSTEM COMPONENTS osse e oe nee ee GREG OE RE ee ee GE Ee GR Ge EE ER GE ie Gee OG N Es ee 18 DETAILED DESCRIPTIONS OF SYSTEM COMPONENTS esse esse see ee ee ee ee ee 19 FOUI eoaratien OIC S eed EE ee EE GE de OE Ee Go Pe de eb oe Ge GE Ge OG Pe 19 2 Sample Disposable Unit BioCEP Disposable Kit sesse ee see ee ee ee ee ee ee ee ee ee ee ee ee ee ee 19 4 Builler Disposable Unit GER KIT es os ie ER ie De GE ik oe Oe ee 19 A Burner reine EE EE ER OE N EE EO EE EE N N 19 2012 BioCEP Ltd Page 3 BIOCEP User Manual About this Manual CEPir 5 0 t eee ee ee ee ee Re ee Ee N ER ee ee eee ee 20 EFON RONO a en eee Ee oe 20 Vf BOS 6 2 S el cl E cee ee E E A ANE E LA E ne T a 20 Be BU a PURE ee re ee eee eee 20 SS as ACO PO RE N OE EE N 20 TO Sable PURE es ee EE swe E ED N eee 20 di Veitilatlom Oben ie ee EE EA EG ER N EE N EE ee ee eee eee roe 20 12 Sample vessel angle handle ee nr EE EE ee Re De 20 13 Separation disposable unit Mixing Chamber ees sesse see de ee ee ee ee ee RE ee ee EE ee 20 14 ear helle en EE Ee E E Ee Ee NE ee EE DE Ge 21 Ms FSS OE SIN ee oe AE EE E ee Ee sa E E ee ee 21 16 EE DO Ee EG OG ee ee ee ER EE eee eee 21 WORKING UNDER A LABORATORY HOOD steak visse pe se ge se Er n Ge se Ge UGO Ee De ge N ke ee ne ee oe Ge 21 8 INSTALLING DISPOSABLE COMPONENTS AND SAMPLE esse see esse esse sees ee see ese eke eN ee RE ERG Re Re ee 22 LOCATION OF THE
47. on time out If the magnets are left on for a period longer than the configured number of minutes the running scenario is stopped and the magnets are turned off This is required to protect the unit from overheating Save Save the new values Cancel Return to previous menu 2012 BioCEP Ltd Page 45 BIC CEP TT Running the Cell Separation Epic Scenario When the Scenario is running Run from the main screen CEPir displays a status screen showing the scenario s activity The following pages show examples of the status screen SCENARIO STATUS EXAMPLE 1 BEGINNING OF SCENARIO In this example buffer fluid is flowing into the mixing vessel 00 00 11 Log Enter a user comment to the CEPir log file Info Display an on screen legend explaining the icons used on the Scenario Run screen Pause Temporarily pause the scenario operation 2012 BioCEP Ltd Page 46 Running the Cell Separation CEPir Scenario BICEP User Manual SCENARIO STATUS EXAMPLE 2 PAUSED SCENARIO In this example the user has pressed the Pause button The scenario is temporarily stopped with the option to Resume operation or to Exit from the scenario 00 02 40 Exit Cancel execution of the scenario Log Enter a user comment to the CEPir log file Info Display an on screen legend explaining the icons used on the Scenario Run screen Resume Resume execution of the scenario 2012 BioCEP Ltd Page 47
48. ort these scenarios Separation Scenario Basic Isolation Scenario fill separation rinse collection Separation Scenario Basic Isolation Intense Rinse Scenario fill separation rinse collection 6 IMPORTING A SCENARIO From the main menu click on Import Separation Scenario Generator Versior FH OUE Enrichment Process A standard Windows dialog box will display Be EE ger r Open xml file La L 28 G J Local Disk C gt biocep Separation Scenario Generator gt v Search Separation Scen 2 Organize New folder sv i Favorites Name Date modified Type Size E Desktop J saldrivers 02 Feb 12 942 AM File folder J Downloads exp Lxml 02 Feb 129 55AM XML file 16 KB Recent Places exp 2 xml 02 Feb 12 957 AM XMLFile 16 KB J 21 BioCep exp3 xml 02 Feb 12 10 08 A XML File 16 KB my_scenarios xml 19 Feb 12 8 03 PM XML File 16 KB protocol No 4 xml 29 Jan 12 9 55 PM XML File 8 KB protocol No 5 xml 29 Jan 12 9 55 PM XML File 9KB File name protocol No 4 xml v Biocep config files xml v Open M Cancel Choose the desired Separation Scenario and press Open A confirmation screen will display showing summary information about the Separation Scenario Import E3 Import Summary users user name master user name user E user name batel protocols protocol name protocol 4 operation num 1 type Priming action nu
49. osing a scenario 2012 BioCEP Ltd Page 35 BIQCEP User Manual Preparing for a Cell Separation CEPir CALIBRATION This screen allows you to calibrate the pumps magnetic separators or touch screen Calibration Data Pumps Calibrate Pumps Bue Sampe Separator 16 15 16 Separators Calibrate Separators 100 95 200 156 300 216 ANN 214 500 289 600 341 700 302 800 439 Calibrate Screen Click on Calibrate Pumps Calibrate Separators or Calibrate Screen The appropriate calibration screen will display Click on Done to return to the main screen The Pump and Separators information Rate Volume mA Left mT Right mT shows the current values for these parameters 2012 BioCEP Ltd Page 36 BIQCEP User Manual Preparing for a Cell Separation CEPir PUMPS CALIBRATION SCREEN 1 OF 2 FILL TUBING WITH BUFFER FLUID Use this screen to perform calibration of the buffer sample and separation pumps Pump Calibration First follow these steps to fill the tubing with buffer solution 1 Fill the buffer container with Dulbecco s Phosphate Buffered Saline PBS solution Click on Fill for the Buffer pump This will activate the pump motor e Note that the word Fill on the button now changes to Stop 3 Click on Stop when the silicon tubing is completely full and no air bubbles are in the tube This will stop the pump 2012 BioCEP Ltd Page 37 BIC CEP User Manual Preparing for a Cell Separation CEPir
50. perform pump calibration page 36 prior to proceeding with separations Page 33 BIOCEP User Manual Preparing for a Cell Separation CEPir INITIAL SCREEN FOR BIOCEP PERMISSIONS LEVEL USER GP 1432 File Zoom Display Tools Help 5 4 low field 150mT EE Active User auto fil G ros enh rinse ie low field 150m1 Administ ator high field 600mT Maintenance Calibration Status Buffer Pump Administration Sampe Sump Separation Pump H H H H Cell Enrichment Process v1 41 1 User information 2 Default scenario name for this user The default scenario is automatically set to the last scenario selected 3 Description of the selected scenario 4 System information 5 Select a scenario page 35 6 Run the selected scenario page 46 7 Open Scenario Manual Run screen 8 Calibrate the pumps touch screen and magnetic separators page 36 2012 BioCEP Ltd Calibration Element Run Count LastTime Status 3 14 2012 9 30 AM OK 3 14 2012 9 32 AM OK 3 14 2012 9 34 AM 9 Administration Edit scenarios import export XML files set scenario active inactive page 42 Update firmware page 43 Export log file page 41 10 Set degauss voltage set pump properties page 45 11 Calibration Status e OK Pump is OK e Calibrate You must perform pump calibration page 36 prior to proceeding with separations Page 34 BIQCEP User Manual Preparing for a Cell Separation CEPir SEPARATIO
51. ponents and Sample CEPir STEP 4 PLACE THE BUFFER DISPOSABLE UNIT SEE ITEM 3 ON PAGE 19 Place the straight connector into the Buffer Cap Place the blue Pump Key into the Buffer Pump door see item 8 on page 19 the blue pump Place the tubing Ensure that the tubing is in the correct path and is not pinched when closing the pump door Close the pump door Depress the blue shutter of the mixing vessel until it is fully down Connect the 90 blue buffer connector into the opening in the blue shutter Make sure it is firmly in place Ensure that the pipe runs through the tube arc that leads to the mixing tank 2012 BioCEP Ltd Page 26 Installing Disposable Components and Sample BIOCEP User Manual CEPir STEP 5 PLACE THE SAMPLE DISPOSABLE UNIT SEE ITEM 2 ON PAGE 19 1 Place the Sample vessel into its omega vessel holder 1 a Ensure that the Orientation Tongue is positioned as shown in the figure 1 b You should hear a click when the Sample vessel is in place 2 Open the Sample Pump door see item 10 on page 19 Red pump place the red Pump Key and close the pump door Ensure that the tubing is in the correct path and is not pinched when closing the pump door 3 Depress the red shutter of the mixing vessel until it is fully down Connect the red sample connector to the opening in the red shutter Make sure it is firmly in place 4 Close pump door Orientation Tongue
52. pumped 0 1 ml to 40 ml Caption Title of the message Text Body of the message Select vial nur Select magnet apres SA EP S Stren 45 mT Pump Select pump and parame Rate ml n 4 0 Volume ml 4 0 gt User Text Add Edit instruction or warning Caption Text Check that the Buffer and Separator tubes are full with liquid Page 67 BIOCEP User Manual CEPir Maintenance CEPir CHANGING THE TIMING AND DEPENDENCIES OF A PROCESS STEP The timing and dependency condition of a process step refers to exactly when CEPir should begin the step The default action is to perform each step only when the preceding step has completed However more complex scenarios can be created Some possibilities for dependencies are e Begin step 3 after step 1 and step 2 have completed default e Begin step 3 after step 2 has pumped 0 5 ml of fluid e Begin step 3 after step 1 has completed e Begin steps 2 and 3 simultaneously In order to edit the dependencies of a step first click once on the step then click on Dependency Functions Proc Component Param 1 Param 2 Param 3 1 Carousel Vial 2 Rate 3 mi minVolume 1 ml In this example we click on Step 4 Pump and the dialog box appears that is shown below The purpose of this dialog box is to set the dependencies of Step 4 In other words we are now deciding when to begin Step 4 Click here to start Step 4 during the execution of Step 3 Si
53. r MAGNETIC SEPARATORS CALIBRATION This screen is used to calibrate the electromagnetic separators Separator Calibration Fi Note CEPir comes with a pre calibrated magnetic field Only BioCEP technicians can re calibrate magnetic field strength since this procedure requires special measurement tools 2012 BioCEP Ltd Page 39 BIOCEP User Manual Preparing for a Cell Separation CEPir TOUCH SCREEN CALIBRATION The Calibrate Screen button activates the touch screen calibration process Calibration Mode Select Click on the preferred mode Wait 4 seconds to 9 Points 4 Points 9 Points There are three options for touch screen calibration 4 points 9 points and 16 points Using a higher number of points may result in a more accurate calibration but will take longer to perform the calibration process If no button is pressed within four seconds the system will automatically choose the 9 points calibration option For all calibration options follow the on screen instructions to proceed with the calibration 2012 BioCEP Ltd Page 40 BI P User Manual Preparing for a Cell Separation CEPir THE ADMINISTRATION SCREEN The Administration screen is used to perform system level functions such as importing or exporting separation scenarios and changing the device setup CEP Scenarios Display the Scenarios Management screen for XML Import Export page 42 CEP Hardware Display the Firmware Image Man
54. ration Scenario Generator BI me EN OUE Enrichment Process Scenarios Versior IT Deseription Scenario Name ID User 1 master 2 master protocol 5 no 3 master sl User Switch users master Current user Version 1 65 Software version number New Create a new scenario Delete Delete a scenario Export Save scenarios and users in an external file Import Retrieve scenarios and users from a previously exported file Users View and edit the list of users Scenarios A list of currently defined scenarios 2012 BioCEP Ltd Exportable protocol 4 yes Y yes no bubble ID A system assigned identification for the scenario User Name of the user who created the scenario Scenario Name Name of the scenario Exportable Yes The scenario will be included in the export file when clicking the Export button No the scenario will not be included in the export file Description A brief description of the scenario Page 59 BIOCEP User Manual CEPir Maintenance CEPir 5 ADDING USERS AND CHANGING PASSWORDS Although you can use SSG with the default user of master we recommend that you define a new user You may also wish to remove the master user First click on Users Separation Scenario Generator User B Versior IT Cell Enrichment Process Then click on Add Users Permission Password Expert Mode 22222 YE no 4 IH p Remove Change
55. t BioCEP disclaims all implied warranties of merchantability fitness for particular purpose and those warranties arising by statute or otherwise in law or from a course of dealing or usage of trade Notwithstanding anything to the contrary herein BioCEP shall not in any case a be liable for any special consequential exemplary incidental or indirect damages including but not limited to loss of profits revenues data and or use even if advised of the possibility thereof or b any claim regarding the Product brought more than eighteen 18 months after the cause of action becomes know to the party bringing the claim BIOCEP S LIABILITY AS SET FORTH HEREINABOVE SHALL NOT IN ANY CASE AND FOR ANY REASON WHATSOEVER EXCEED THE PRODUCT S PURCHASE PRICE ACTUALLY RECEIVED BY BIOCEP BioCEP Ltd Rebecca Sieff Medical Center P O B 1008 Safed 13100 Israel Tel 972 4 6828828 7 Fax 972 4 6923753 Email info biocep com support biocep com Web www biocep com 2012 BioCEP Ltd Page 72
56. tion vial PROCESSES AND RELATED FUNCTIONS The following table illustrates the basic processes and related functions CAROUSEL DEMAGNETIZE MAGNET PUMP USER Select a vial Turn off both Turn on an electro Choose separator Display a message electromagnets magnet buffer or sample pump Separation Collecting 2012 BioCEP Ltd Page 64 BIQCEP User Mandal CEPir Maintenance CEPir ACTIONS AND PARAMETERS The following table illustrates each function and its associated parameters Carousel Vial Select a vial no 1 2or3 Pump Separator 0 5 to 20 0 1 to 50 Select pump buffer or ml per ml sample minute pump User Display a text text message E 150 to 850 T left or right urn on an T electromagnet Demagnetize Turn off both no parameters electromagnets 2012 BioCEP Ltd Page 65 BIOCEP User Manual CEPir Maintenance CEPir EXAMPLE DETAILED EXPLANATION OF A PROCESS If you click on the fifth process in this example you will see detailed information on the Collecting process Process Functions n Priming Proc Component Param 1 A Fill 4 Carousel Vial 2 Si Separation 2 Demagnetize Ri dans 3 Pump Buffer Rate 3 mi minVolu amp Separator Rate 3 ml minVolu Here is an explanation of what the Edit Scenario screen is telling us about the four functions in this process Proe Component Param 1 Param 2 Param 3 Cond 1 1 Carousel Vial 2 2 Demagnetize step 1 Carousel
57. to hold it by the back handle and the front handle Always use the original packing materials when moving or storing the CEPir Warning Changes or modifications not expressly approved by BioCEP Ltd could affect the safety and effectiveness of the system and will void the system s warranty Warning The system contains no user serviceable components Do not open the system covers Warning The device is authorized for use only as explained in this User Manual If the equipment is used in a manner not specified by the manufacturer the protection provided by the equipment may be impaired Warning Appliance coupler is used as disconnect from mains power device Caution Always disconnect the device from the mains before servicing EE BPP Ee Caution INVESTIGATIONAL DEVICE Limited by Federal US Law to Investigational Use Only Note The information contained in this User Manual is intended for the sole and exclusive use of the company s customers with the CEPir Any other use of this manual or of any of the information it contains is prohibited Documentation needs to be consulted gt N o 2012 BioCEP Ltd Page 9 BIQCEP User Manual Safety CEPir SPECIAL SAFETY INSTRUCTIONS FOR HANDLING POWERFUL MAGNETS Caution This special caution label is affixed to the device in order to make users aware of the precautions necessary when using strong electromagnetic fields The four separation units see illustration below

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