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switching on the macotronic b2 - Blood Safety

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1. 86 Available FUNG a 86 WGI 88 Avallabie CRUS 88 Process Menti n 90 Available 90 Pur soeia KERNE SERENE SEE 92 Available TANG MON 92 Mantenan Ce t c M 94 Available function CN E 94 Pic MENU eM RTT UR 96 Available ERE 96 E ER 97 Date TIE mee 98 Available 98 Current maintenance procedures 102 Hardware 102 Preventive maintenance 102 Fanar grids Cle AMIN ee EE TEE 103 External parts Cle cue ERSTER 103 internal pans INA Go 104 Internal glass cleaning 222 105 RED OEE Tm 105 Barcode 0 105 Errors and curative maintenance procedure
2. eese 62 Operating mode with auto print label 62 Operating mode with auto print label disabled 64 Remarks ERROR 66 Ending tne illumination iUa ay aa 68 Operating mode RN RR ELEC 68 zi dre inl pfe Kol PEE E E ET EODEM 70 Switching off the peripheral 70 Switching off the MacoTronic B2 70 Reprint report or TAD Cl 72 Fe OLE 72 RP 73 SENO MENUS sssi 76 Aim of the settings 76 Access to the setting Menus soto tnit Eos pls etin D dud 76 Note concerning the buttons 77 go TO eee E 78 User management MeO AU 80 PV AMADIS E 80 scsosus a 82 Available TING 82 Table of content V
3. Figure 143 RFID warning Error level Warning error Cause Connection error with the DataManager Consequence Illumination data can be transferred to the Macotrace Corrective action Check if the Datamanager is switched on and correctly connected to the machine Perform a manual import on the Macotrace once the problem is fixed Figure 144 120 RFID warning MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Error level Warning error Cause Maintenance has to be done for optical block Consequence Illumination time may be longer Corrective action Contact your Macopharma representative to plan the maintenance ERROR CODE ON ILLUMINATION REPORT All errors and messages are logged in the report journal The report journal is automatically printed after each illumination cycle on the report printer Error label Error description codes Correct ending References 0000000 reatrm nt corect 1115 AM 9003111 15AM 8009 11 15AM 8003 1 1 15AM 003 1037 AM 5001 10 53 gt 8001 Macctoric sera number MBO amp 3501 serial marter 836 date 2010 02 05 T11 1509 0100 Bumeahon date 2010 02 05 T11 15 00 01 00 Fite MBO amp 83501 20100208 001 D 148083801 20100205 001 1 Figure 145 Example of illumination report with error codes left side or without report code right side Errors and curative maintena
4. Atmospheric pressure 500 hPa to 1060 hPa 126 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b INDEX 9 93 42 CEE 126 93 42 EEC 126 A Aborting the illumination 59 Absorbed energy 125 Air fan Maintenance 102 103 Air humidity 36 Already illuminated bag 114 Altitude 125 Approvals Electrical 124 Auto log off Settings menu 81 Automatic stop of illumination 27 58 B Bag Already illuminated 114 Check presence 90 Dotation code error 112 Invalid detection 111 112 Label print 87 Misplaced 27 56 RFID reader 125 Temperature management 125 Temperature too high setting 82 Bag label print 87 Bag temperature setting 82 Bar code printer Socket 16 Bar code reader Socket 16 Barcode Sticker to be fixed 63 65 66 Barcode 88 Barcode checking 27 62 64 66 Barcode control 91 Barcode label printing 27 62 64 66 Barcode printer Connection 40 Description 19 Socket 16 40 Barcode printer COM port 87 Barcode reader Connection 40 Description 18 Maintenance 105 Socket 16 40 Technical characteristics 18 battery 7 Blinking light 58 Buttons Colors 77 C Casing 124 CE Marking 9 17 CEE 93 42 126 Characteristics Main 15 Check Barcode 27 62 64 66 Check bags presence 90 Cleaning 7 External 102 103 Internal 104 Internal glasses 105 Closing drawer 26 54 Code error Display 121 COM port 87 Communication outputs 15 Compliance ce
5. Figure 140 Cycle error MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b 118 Error level Critical error Cause An hardware error occured Consequence Illumination is stopped The failed source appears in red color on the screen A data back up with error code invalid treatment for every bag is carried out Corrective action Write down the error code and discard the bags CYCLE WARNINGS Cycle warnings are displayed at the end of the cycle These warning mean that something went wrong during the cycle but the treatment is still valid An icon will be display under the bag for which the errors occurs Please note that multiple icon can be display Error level Warning error cA 28 Cause Bags temperature have exceeded the threshold set in the temperature settings menu Consequence Inactivation result is not affected Depends of your operating mode Figure 141 Corrective action Bag Temperature warning Change the thresholds Check the plasma temperature before inactivation If the problem persist contact you Macopharma representative some fans might be defective Maco Error level Warning error a aa BB Cause RFID tag cannot be written Consequence Illumination data cannot be written on the tags Corrective action Replace the tags Figure 142 RFID warning Errors and curative maintenance procedures 119 e
6. 128 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b EMC 9 Ethernet wall socket 36 Fuse type 17 General data 124 Guarantee 10 Laboratory 36 Limit of responsibilities 11 Main characteristics 15 Mass 124 Mechanical data 124 OFF soft button 29 70 On push button 23 44 Packing content 33 Packing material 33 Peripheral space 36 Place of use 14 Power on 23 44 Power rating 17 Power supply wall sockets 36 Power off 29 70 Property rights 11 Purpose 14 124 Room temperature 36 Safety requirement 35 Serial number 17 Storage 34 Transport 33 Type 17 Unpacking 33 Voltage rating 17 Weight 124 Working area 36 Error Display 121 Reminder 108 Ethernet Socket 16 40 125 Wall socket 36 Ethernet socket Localization 16 External cleaning 103 External devices Front side 16 Localization 16 Rear side 16 External parts Maintenance 102 103 104 F Fan Outputs 16 Fan ouputs Localization 16 Fan outputs 16 File transfer 96 97 Free space Internal memory 96 USB key 96 Frequency 125 Current maintenance 102 Front panel Localization 16 Front side External devices 16 Fuse 16 125 Localization 16 Type 17 G General data 124 Glass bottom drawer Maintenance 102 104 Graph of 57 Guarantee 10 H Heat symbols Safety 6 Holder 3 How to 78 Humidity 36 Storage 125 Working 125 126 Icons During illumination cycle 46 On
7. With end processus screen Transferring data Illumination start after scan Manage user Print report button Bar printer COM port n Print report Product code Print report With RFID With RFID Warning temp threshold of bag C Maximum temperature to start C Transferring data Transferring data Transferring data Manage user Manage user See page 90 91 62 90 91 91 87 91 97 91 97 90 80 86 87 86 88 86 89 89 84 84 97 97 97 80 80 Settings menu 79 USER MANAGEMENT MENU AVAILABLE FUNCTION User Management TETT The functions are described below Password Auto Log off Reprint Access for user Figure 98 The Settings menu when displayed Manage user Click on this button to select one of the two choices W Password at the beginning of an illumination cycle the standard password screen will be shown The user should enter his user s name and his password Barcode at the beginning of an illumination cycle the password will be entered scanning bare code X Wife ere Figure 99 Figure 100 When Password is selected this screen will be When Barcode is selected this screen will be displayed at the beginning of an illumination displayed at the beginning of an illumination cycle cycle 80 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Auto log off Define the display status of the login screen at the beginning of each il
8. s es Del Galea Oh ead d properly place in the drawer and if the tags are valid 2211 Wrong Donation Number for Bag 1 2212 Wrong Product code for Bag 1 2213 Wrong Lot Number for Bag 1 Checks the bag 2221 Wrong Donation Number for Bag 2 identification data format 2222 Wrong Product code for Bag 2 2223 Wrong Lot Number for Bag 2 Kit Type 2310 Wrong Kit Type for Bag 1 Use a correct Theraflex kit Application and contact your Code 2320 MacoPharma representative Bag Status 2410 Bag 1 has already been illuminated Bag Status 2420 Bag 2 has already been illuminated Be 414 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Datamanager error code table 2611 Bag 1 is reserved DM by another 2611 machine 2612 1 has already been illuminated according to the DM 2613 1 is refused by the DM for unknown reason data and the Macotrace list 2621 Bag 2 is reserved on DM by another 2621 i machine 2622 Bag 2 has already been illuminated according to the DM 2623 2 is refused by the DM for unknown reason Errors and curative maintenance procedures 115 PRETEST ERRORS Pretest error occurs just before starting the cycle This means that if an error occurs during pretest the cycle hasn t started yet therefore you can try to run another cycle with these bags All the bag data validation error code will be in the following range 3000 3999 Figu
9. Before switching on the 2 23 Switching on the MacoTronic 2 29 User s identification PNE 24 Positionning the bags PRENNE 25 Scanning the plasma packs 25 Launching the TCIM RI Em 26 Barcode label printing and barcode checking NE We ON PENECTUS 28 Extracting the illuminated bags Sep ecce Bern Loo quise ed socer nns 28 Switching off the equipments nnn nnne nnns 28 IV MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Transport storage ANd 33 Die e IO 33 Controls during the unpacking MENT 33 ee 35 Safety requirements 35 Equipment to be WOO TD m 35 E E 35 E E E E E E E 37 CGONHECHONS 39 General connection scheme cccccecseeeccceeeceeeeeeeeceeeeeeaee
10. F10AL250 3 Power supply socket 110 240 V AC 4 Fan outputs upper electronic 5 Fan outputs upper drawer 6 Ethernet socket RJ 45 7 USB sockets Front top to bottom Barcode reader if not connected on front side or USB key Bar code printer 8 Seal Guaranty 8a 9a 10 Ob 8b void if broken Figure 4 9 Fan outputs The rear side lower drawer 10 Fan outputs illumination chamber 16 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Label MacoTronic B2 illumination equipment for THERAFLEX procedure Machine dillumination pour le proc d THERAFLEX MB Plasma Belichtungsgerat f r das THERAFLEX MB Plasma Verfahren Equipo de Iluminaci n para ef sistema THERAFLEX MB Plasma iWuminatore per procedura THERAFLEX MB Plasma SN mm Voltage 110 240 V 50 60 Hz Power 750W Fuse F10AL250V Made in EEC Figure 5 The manufacturer label See instructions for use K 60459 ETEUMTCB2 F Item Description Equipment type SN Equipment serial number N Date of manufacturing Voltage Minimum and maximum input voltages power supply frequency Power Maximal energy consumption Fuse Type of fuses to be used F10AL250V Respect these values Indicates that the reading of the user handbook is mandatory before using the equipment See instructions for use Indicates
11. Figure 23 Scan of donation barcode Quick start 27 d 7 Repeat the steps 3 to 6 for the second EB 8 If the procedure cannot be finished properly press the 4 icon to abort it Figure 24 Scanning and printing of the bag labels PRINTING THE REPORT A report is normally automatically printed EXTRACTING THE ILLUMINATED BAGS 1 Open the drawer if not yet opened and remove the illuminated bags Figure 25 Extracting the bags SWITCHING OFF THE EQUIPMENTS 4 Maco 1 Power off the peripheral equipment s label printer log printer PC computer 2 If the 9 icon is not displayed touch the 4 icon Figure 26 The welcome screen 28 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Touch the 5 icon Figure 27 The OFF soft button 3 In the opened window touch the corresponding button No abort the shutdown procedure and return to the Donation screen Yes shuts down the equipment Note the front lights turn off the system shuts down and the screen goes black It takes then about two minutes to completely shut down the machine fan stop until the internal MacoTronic B2 temperature goes below the preset temperature Figure 28 The screen waits the confirmation of the shutdown Quick start 29 30 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b SETT
12. Donation code 5 Scan the second bag Product code Figure 16 6 Scan the second bag Lot code Scanning OFS teed 7 Touch the icon to display the next screen Quick start 25 Maceo 8 The waiting screen is displayed 222 Figure 17 The screen waits for the drawer closing 9 Close the drawer Figure 18 Closing the drawer LAUNCHING THE ILLUMINATION 1 Touch the icon Ces Figure 19 The waiting screen with is blinking triangle 26 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b 2 The illumination cycle is launched as soon as the timer located inside the ring starts P d Maco NU e Figure 20 The screen during an illumination cycle B8 2 3 Illumination automatically stops for each unit once the quantity of energy defined by THERAFLEX MB Plasma procedure is reached Figure 21 The screen at the end of an illumination cycle BARCODE LABEL PRINTING AND BARCODE CHECKING Note this paragraph 15 to be followed only if this function has been activated If not continue on paragraph Printing the report 1 At the end of the cycle the label for bag 1 is automatically printed stick it on bag 1 2 The label screen is displayed See figure on the left Figure 22 The first label screen 3 Scan the bag donation barcode in the first field 4 Scan the label barcode in the second field
13. If the procedure cannot be finished properly press the 4 icon to abort it Continue on paragraph Ending the illumination cycle on page 68 M Barecode label printing and checking 63 OPERATING MODE WITH AUTO PRINT LABEL DISABLED In this case you need to scan the original donation barcode to print the label and then you can do the crossmatch 1 The label screen is displayed See figure on the left Figure 72 The first label screen 2 Scan the bag donation barcode of the first bag Figure 73 Scan of donation barcode 3 If the donation barcode is correct the label is printed automatically and the next field is selected 4 Stick the printed label on the bag Figure 74 The original label has been scanned once and printed The crossmatch can be done 64 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b 5 22026141875 0261 875 in Figure 75 The two first scan have been done X Maco 6 re 22026141875 mt 44026141875 ee u D Figure 76 9 The two first scan have been done 10 11 Scan the original donation barcode again if the scan is correct the last field will be selected Scan the printed label If the printed label barcode is correct the field background will change to green and label screen for bag two will be displayed If the printed label barcode is correct the field background will change to red If necessary repeat the
14. Launch Maintenance software Figure112 The Process menu when displayed Button List This button are not toggle button but action button use it only if a MacoPharma representative request it Enable the remote control functionality Cab ENDE PERT Disable the remote control functionality Launch maintenance software Launch the maintenance software 94 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Maintenance menu 95 USB MENU AVAILABLE FUNCTION The icons are Maco Fie ip hp S Figure 113 The Process menu 96 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Eject USB Deactivate the USB key before extracting it from the USB connector Select the language file for a transfer Select the illumination data file MT2 for a transfer Select the user list file for a transfer Select the parameter file for a transfer Select the mask file for a transfer Select the transfer log file for a Click on this button to transfer from the MacoTronic B2 to the USB key the selected data Click on this button to transfer from the USB key to the MacoTronic B2 the selected data Picture of the used memory on the USB key Picture of the used memory on the MacoTronic B2 internal memory TRANSFERRING DATA This function allows transfer of data from the MacoTronic B2 to an USB k
15. Print 86 Auto Log off Bag identification 88 Process 90 Reprint Access for user DM 92 Maintenance 94 USB 96 NOTE CONCERNING THE BUTTONS The buttons are presented with three possible states as follows State Background Foreground Meaning Non available function disabled Function Name Grey Blue Non activated function a Blue Blue Activated function Settings menu 77 How TO Action to be carried out Automatic checking of bag presence Bag checking with Data manager Bag label printing end of illumination Bag presence detection automatic Barcode comparison Check bag with DM COM port of the barcode printer Data Manager Data transfer End processus screen selection File transfer Illumination starting after scan Password checking Print report mode with without graph Printer barcode printer COM port Printer Report printer selection Product code entering field Report printer selection RFID activation RFID presence Temperature maximum of bag Temperature maximum to start Transferring data USB key USB transfer User s name manual entry User s name scanner entry 78 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Paragraph name Check bags presence Check bags with DM Barcode label printing Check bags presence End illumination barcode control Use of the DataManager software Bar printer COM port n With DM Transferring data
16. been deactivated grey button Activated this option displays an end process screen With end processus screen With end processus screen Maceo Grayed button and foreground indicates a non accessible function To enable this function open the User management function see page 81 and deactivate the Auto Log Off button it must be grey Blue button activated function the choice screen Figure is displayed Grayed button and blue foreground non activated function the login screen Figure is directly displayed Maco Figure 109 Figure 110 When the With end processus screen button is When the With end processus screen button is activated this screen is displayed at the end of not activated this screen is directly displayed at an illumination cycle the end of an illumination cycle End illumination barcode control Activated this option avoids errors that can occur during the reading and the printing of the label and allows verifications that the user has stuck the MacoTronic label on the correct bag End Illumination Barcode Control End Illumination Barcode Control The function cannot be enabled because the label printing is not enabled Grayed button non activated function the barcode comparison process between the original and the printed label is not requested Blue button activated function the barcode compariso
17. by MacoPharma or be distributed reproduced translated disassembled decompiled analyzed adapted modified incorporated or combined with another software except the cases authorized by the law Guarantee 11 GENERAL PRESENTATION 12 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b 13 DESCRIPTION PURPOSE OF THE EQUIPMENT The MacoTronic B2 equipment is used for the illumination of plasma bags according to the THERAFLEX MB Plasma procedure Only bag systems for THERAFLEX MB Plasma treatment provided by MacoPharma BSV BRJ ZDV SDV SRV SPV JPJ series must be used in combination with the device MacoPharma is excluded from all liability or responsibility for any other non specified use The MacoTronic B2 is an illumination device with the following characteristics Completely embedded computer controlled illumination process W Capacity of 2 bags per cycle Double side illumination system using LED technology 2 panels of 24 LED per bag position Control of energy supplied by each panel by photo diode m Temperature management inside illumination chamber using laminar air flow fans with monitoring by pyrometer for each bag Data traceability bag identification light intensity energy delivered time temperature Figure 1 The MacoTronic B2 equipment drawer opened PLACE OF USE The MacoTronic B2 equipment has to be installed in clean room on a fixed support being able to support
18. equipment Note the front lights turn off the system shuts down and the screen goes black It takes then about two minutes to completely shut down the machine fan stop until the internal MacoTronic B2 temperature goes below the preset temperature Switching off 71 REPRINT REPORT OR LABEL REPRINT At any time you can reprint the illumination label or the report for a bag P Kw 1 Login as Administrator 2 Click on the printer icon Figure 88 The administrator screen 3 Scan the donation barcode 4 Scan the product code if needed Figure 89 The retrieve bag screen To reprint a label click on the barcode icon To reprint a report click on the printer icon Figure 90 72 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b 1 Donation 44026141875 Product WBPLS Found MB083101 20111205 001 1 MT2 Figure 91 Donation MAALE Product WBPLS Found MB083101 20111205 001 1 MT2 Figure 92 Figure 93 Reprint Menu access for user If you have printed a barcode then you need to perform the crossmatch by scanning the printed label If the crossmatch is successful the field background will change to green otherwise it will change to red If option is enabled users cannot access to the reprint menu by pressing the printer button in the bag identification screen Reprint report or label 73 SETTINGS 7
19. if exposed to light doses for 60 min In all cases the validation or quality control data and acceptance criteria of the respective blood bank under their routine production conditions are pivotal 4 Stefan Reichenberg Scientific Marketing Manager Transfusion 8 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b CE MARKING The equipment has MDD 93 42 EEC marking located rear 0459 ofthe MacoTronic B2 equipment DESTRUCTION OF THE EQUIPMENT harmful electronics components for the environment It is requested to the owner to get into contact with the producer or distributor in order to take note of the procedure to be followed for the recycling of the MacoTronic B2 equipment The producer cannot be responsible for the recycling of a MacoTronic B2 equipment which will not have followed the definite procedure In accordance with directive 2002 96 CE this device can be made up by battery will be removed prior to the destruction of the MacoTronic B2 and The equipment contains a button type battery for the real time clock This deposited in a collection center for used batteries DECLARATION OF CONFORMITY TO THE STANDARDS The medical device for inactivation of pathogens in plasma by photo treatment with methylene blue THERAFLEX MB Plasma procedure conforms to the European Directive 93 42 EEC The MacoTronic B2 illumination equipment conforms to the following
20. norms Electrical safety EN 61010 1 2010 and EN 61010 2 081 2001 Security rules for electrical apparatus for measuring regulation and the laboratory EMC EN 61326 1 2006 Measuring Control and Laboratory Electrical systems Class equipment Safety 9 GUARANTEE LIMIT OF RESPONSIBILITIES AND PROPERTY RIGHTS GUARANTEE The guarantee of the equipment only applies if the equipment is installed in accordance with the present handbook and is used in accordance with the delivered instruction manual It does not cover the consumable such as the LEDs and holder for storage bag During the installation of the equipment the guarantee is invalidated in the following cases E Connections with invalid peripherals electrical power supply connections of the equipment not envisaged m Use maintenance or repair by a not competent personnel m Use of spare parts and accessories not approved by MacoPharma The period of guarantee runs starting from the date of emission of this delivery form for one year duration The delivery of the goods is under the responsibility of MacoPharma when this one is carried out by a forwarding agent approved by MacoPharma In the other case this one is under the responsibility of the purchaser MacoPharma guarantees the supply against any design defect or construction affecting the MacoTronic B2 equipment The guarantee of MacoPharma is strictly limited with the choice of MacoPharma to the repa
21. printer log printer PC computer 2 HING ON THE MACOTRONIC B2 1 Check that the drawer marker 2 is correctly closed An opened drawer inhibits the checking procedure 2 On the MacoTronic B2 equipment push the On button marker 3 and release it The front lights go up blue continuous light marker 1 Figure36 The On switch 44 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b 3 The initializing screen appears during the MacoTronic B2 initialization procedure Messages are displayed in the center zone according to initializing az NOE process If an error occurs during the start up check first the eventual presence of a bag into the drawer MB PIiasma Figure 37 The initialization screen 4 After the initializing the login screen is displayed 5 The MacoTronic B2 equipment is ready to be used as described on page 48 Figure 38 The login screen SETTING THE WORKING PARAMETERS Before using the MacoTronic B2 equipment the authorized user administrator should set the equipment parameters as described in chapter Settings on page 74 Starting up 45 ICONS DISPLAYED ON THE SCREEN The following tables show the various icons which can be displayed onto the various screens Right screen side 2 Logged user with his name Drawer status closed Drawer status opened Average equipment internal temperature red icon indicates that the 4 m
22. report and the label Date Format Display ddMMyyyy day month yearie 30 03 2012 for 30 March 2012 MMddyyyy month day yearie ss 30 03 2012 for 30 March 2012 Time Format Display le 02 34 59 PM PAM HHmmss 14 34 59 Date time menu 99 CURRENT MAINTENANCE 100 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b 101 CURRENT MAINTENANCE PROCEDURES The current preventive maintenance actions cover the maintenance and the regular cleaning of the equipment the users will have to carry out In addition to assure safe trouble free service the Macotronic B2 has to be A serviced at least every 12 months by a qualified and certified technician according MacoPharma procedure twice a year minimum is highly recommended in case of intensive use Every 24 months or after 12 000 cycles the 4 optical blocks have to be exchanged in order to recalibrate the integrated photocell and perform a complete LED aging control HARDWARE REQUIREMENTS Before carrying out the current maintenance of the equipment the user must have the following tools Aclean work bench Akit of cleaning baby wipes absolute ethanol lint free clean cloth PREVENTIVE MAINTENANCE FREQUENCY The preventive maintenance actions are limited to the cleaning of the equipment The preventive maintenance will have to be carried out as indicated in the following table Item Frequency Rear air fan grid
23. the bag has to be thrown away Some messages are only warning messages Errors and curative maintenance procedures 109 W Tests are performed during The initialization of the machine Autotest The bag identification Bag Data Validation Before starting a cycle Pre Tests During the cycle Cycle Tests The only errors which are critical and could lead to the bag destruction are the errors which happens during the cycle E When problem occurs always write down the date and time the error code and what you were doing on the machine just before the errors have occurred Then call your MacoPharma representative 110 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b AUTOTEST ERRORS An Autotest error occurs during machine startup All the Autotest error code will be in the following range 1000 1999 If an error occurs the only verification that you can do is to check if there is nothing forgotten in the drawer and restart the machine if the problems persist contact a MACOPHARMA representative Error level Critical error Error code Cause 1021 T Software configuration is not correct Consequence occurs Autotest cannot be started uring machine Corrective action initialization Close the drawer Figure123 Screen displayed if an initialization error occurs Error level Warning error Cause The drawer is not close Consequence Autotest cannot be started Corrective action Lead he
24. the bags can be rescanned as they have not been treated Preparing the illumination 55 LAUNCHING AN ILLUMINATION According to the MacoTronic B2 configuration see paragraph Options menu Illumination start after scan paragraph on page 90 the illumination starting is Manual the user is launching the illumination Automatic the illumination starting is automatic as soon as the drawer is closed 7 No illumination cycle will be launched until the inside temperature of the system 1 correct MANUAL LAUNCHING To change to an automatic illumination launching see paragraph Options menu Illumination start after scan paragraph on page 90 1 The screen is as per figure on the left 2 Touch the icon A new screen is displayed Figure60 The waiting screen with is blinking triangle 3 The illumination cycle is launched as soon the timer located inside the ring starts If an error occurs bag misplaced etc the corresponding error message is displayed In this case refer to Errors Message section before any other action regarding the bag In the rotating ring data is continuously updated Figure 61 The screen during an illumination cycle 56 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b The displayed information is as follows 0 85 Jiem Current quantity delivered energy defined as per THERAFLEX MB Plasma procedure fo
25. the right side of the screen 46 Identification User 24 48 Illumination Abort procedure 59 Automatic stop 27 58 Bag already illuminated 114 Barcode control 91 Drawer 16 End of cycle 28 68 End of cycle information 58 Energy received 57 Graph 57 Information 57 Light intensity 57 Manual launching 56 Manual stop 59 Product code 89 Saving data 60 Start after scan 90 Temperature exceeded 57 Illumination block Characteristics 125 Light power 125 Wave lenght 125 Illumination box Characteristics 125 Illumination drawer Localization 16 Illumination start after scan 90 Indicator Power on 16 Information End of cycle 58 Initialization 24 45 Internal cleaning 104 Internal glasses Cleaning 105 Internal memory 96 Invalid detection 111 112 K Key USB 96 97 L Laboratory 36 LCD Display 16 124 LCD display Localization 16 LED 125 Light front Status 58 Light intensity 57 Light power 125 Limit of responsibilities 11 Localization Cover 16 Ethernet socket 16 Fan outputs 16 Front panel 16 Fuse 16 Illumination drawer 16 LCD display 16 Manufacturer label 16 On push button 16 Power on indicator 16 Power supply socket 16 Seal 16 USB front sockets 16 USB rear sockets 16 Login screen 24 45 Lot number 53 Macotrace 93 MacoTronic B2 ON button 23 44 Powering OFF 70 Powering on 23 44 Main characteristics 15 Mainenancet Menu 94 Mains Freque
26. wowinBlood Saretu Close the drawer Figure124 Screen displayed when drawer is opened Error level Warning error A power failure occurred but no Cause E dad A power failure occurred but no cycle was drawer if necessary andpressOK running to continue startup Consequence The machine has not been switched off properly Corrective action Open the drawer to check there are bags remaining in the machine If there are bags you will be able to print label and report from the reprint menu Lead the wow inBiocod Salety Figure 125 Restart after power failure with a cycle running Errors and curative maintenance procedures 111 A power failure occurred while a cycle was running Please remove bags from the drawer and discard it Press the Ok button to continue startup Lead the wow inBiood 4 Figure126 Restart after power failure with a cycle running Error level Warning error Cause A power failure occurred and a cycle was running Consequence The cycle has been abort the treatment is not correct and the bags have to be discard Corrective action Open the drawer to remove and bags and destroy it An error occurs during Autotest please check that the drawer is clean and empty If the error persist write down the error code and contact your Macopharma representative Figure 127 Autotest error message THEFRAF L EX MB Piasmea NE Shutdown R
27. 0V 750 W 57 dBa IEC connector 2 phases earth for report printer if used 2 rear connectors and 2 front connectors through one specific USB connector through one specific USB connector Optical modules optical blocks Power supply Number of LED per module Type of LED Emitted wavelength Light power Power light control Light intensity control Number of optical modules Delivered energy Safety Illumination parameters Others functions Temp management Measurement range HFID reader 24 V DC 24 LED Luxeon 627 nm 10 nm 3W per LED PWM control via optical block board 1 measurement photodiode per optical block Aluminum radiator and one fan per optical module as per THERAFLEX MB Plasma procedure 120 J cm detection of out of order illumination LEDs protected by password Setting from the LCD display commands 2 pyrometers one per bag 0 to 40 C optional ENVIRONMENTAL DATA Working conditions Temperature Altitude Pollution level Humidity Transport conditions Temperature Humidity Atmospheric pressure Storage conditions use in an air conditioned room between 20 C 2 C lt 2000 meters lt 2 according EN 61010 1 lt 80 non condensedq 30 to 75 10 to 80 500 hPa to 1060 hPa Technical data 125 Temperature 10 to 40 Humidity 10 to 80
28. 4 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b 75 SETTING MENUS AIM OF THE SETTINGS MENUS The setting menus allow the setting of some functions of the MacoTronic B2 equipment such as the login method by user name or by scanner RFID detection maximum and minimum allowed internal and bags temperatures file transfer to or from an USB key etc These functions are detailed in the following chapters Moreover the paragraph How to on page 78 summarizes the main actions which can be carried out by the administrator ACCESS TO THE SETTING MENUS 7 1 Login as an administrator 2 Enter the corresponding password 3 Click onto The setting menus are only accessible by the administrator Figure 94 Selecting the Admin7 level x 4 Click onto Figure 95 Selecting the Tools icon 76 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Maco 5 The Settings menu is displayed The other icon functions are User Management X Return to the previous screen Figure Return to the previous screen Figure Auto Log off Reprint Access for user Figure 96 The Settings menu when displayed 6 Click on the drop down list to display Figure 97 the available functions Refer to The Settings menu when displayed paragraph Available settings below Function See page User management 80 Temperature 82
29. BLOOD SAFETY MON y gt gt ify THERAFLEX MB PLASMA MACOTRONIC B2 REV 2 USER MANUAL TRANSFUSION mocophormo DESIGNED FOR LIFE 2 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Copyright JANUARY 2014 by MacoPharma English version Version MTCB2UME10 b All rights reserved Reproduction of this document prohibited without the written permission of MacoPharma Information of this handbook is to our Knowledge exact Because of continuous research and development the specifications of this product can be modified at any moment without notice MacoPharma Rue Lorthiois 59420 Mouvaux France Tel 33 0 3 20 11 84 30 Fax 33 0 3 20 11 84 04 Web site http oloodsafety macopharma com Table of content ill Table of content About this 1 Aim of this IO 968 1 Structure of the NANGDOOK ccccccccceseeeceeeeeeeeeeeecceeeessaeeeceeeesseaeeseeeeeeesssaaeeeeeeessaaaeeess 1 WhO me Cadel ecenin i e eaii 2 How to use this handbook denne onde ndun UE 2 ROM eee ee ee ee ee eee ee ee ee 2 Mentioned trade marks cccccseccccceececseecceceeeceeceeeceeeeccecaueceeseuecessaeeeeseaeesseeeeesseeeesa
30. D bag data validation error Error level Warning error Cause Bag 1 identification data equals bag 2 identification data Consequence Cycle cannot be started Corrective action Restart bag identification step Error level Warning error Cause Bag identification data contained in the RFID tags are not correct Consequence Cycle cannot be started Corrective action Find in the error code table the signification of the error and check the content of RFID tags Error level Warning error Cause Bag identification data are refused by the Macotrace Consequence Cycle cannot be started Corrective action Find in the error code table the signification of the error and check the Macotrace Errors and curative maintenance procedures 113 Error level Warning error Cause The bag has already been illuminated on this equipment This bag has been already illuminated Do you really edil lo Consequence The MacoTronic B2 warns the user who can choose continuing or canceling the cycle Corrective action Click Figure 132 Yes to continue eed alee No to return to the identification screen Remove the bags and contact the administrator RFID error code table Reader 2010 Reader 1 is defective Restart the machine if the problems persist contact Reader your MacoPharma Status 2020 Reader 2 is defective representative Check if the bags are a 2100
31. DM 93 With end processus screen 91 With RDIF 89 Working area 36 Index 131 Working humidity 125 126 Working temperature 125 132 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b ay mocophormo b i kj m Rue Lorthiois 59420 Mouvaux France T l 33 0 320 11 84 00 Fax 4 33 0 320 11 84 03 Web site http bloodsafety macopharma com Appendix A Revision changes for Macotronic B2 user Manual Description of revision 08 11 2013 MTCB2UME10 S W 1 6 0 0 First release MACOTRONIC B2 Rev 2 30 01 2014 Minor change figure numbering MTCB2UME 10 b 134 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b
32. ING UP 32 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b TRANSPORT STORAGE AND UNPACKING TRANSPORT The equipment is shipped on a wooden pallet with a carton cover especially designed to ensure its integrity during transport Figure 29 The transport case CONTROLS DURING THE UNPACKING During the reception initially check the external integrity of the case and then the presence of all the elements listed in the Packing list Using this document follow attentively all the described steps and check the presence of all the parts Once the document completed it will be returned to MacoPharma If a problem occurs during the checking note the problem and contact the local MacoPharma representative or MacoPharma If all is in conformity the MacoTronic B2 equipment could be unpacked A technician approved by MacoPharma will have to install the equipment The MacoTronic B2 equipment will carefully be unpacked near its place of installation Packing content Packing contains the elements described in paragraph Delivered equipment on page 3 All these components will have to be controlled before beginning the installation Packing materials After having checked the contents of the transport packing the installation can be carried out as indicated in the following chapter Transport storage unpacking 33 MacoPharma advises the conservation of the transport packing This one can be re used to dispatch t
33. a total load corresponding to the double of the weight of the MacoTronic B2 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b 14 equipment 54 kg The MacoTronic B2 equipment has to be connected to the mains 110 240 VAC 50 60 Hz 750W and if required to peripheral equipment Ethernet connection for report printer USB connections for Barcode printer and Barcode reader MAIN CHARACTERISTICS The equipment main characteristics are Item Description AC power supply 110 240 VAC 50 60 Hz Electrical consumption 750 W Weight 54kg Noise level 57 Overall dimensions See next figure Communication outputs Ethernet connection for report printer USB connection for barcode reader USB connection for Barcode printer USB connection if required The detailed characteristics are listed on page 122 440 mm 680 mm 470 mm Figure 2 Overall external dimensions Description 15 LOCALIZATION OF THE EXTERNAL DEVICES Front side 1 23 4 5 6 Item Description 1 Front USB connectors Also used for the barcode reader connection 2 LCD display Power on indicator Steady blue when normally working Blinking when illumination ended low frequency or faulty high frequency 4 Front panel b ON push button 7 Figure 3 6 Cover The front side 7 Illumination drawer Rear side 123 4a 5a 5b 4b 6 7 1 Manufacturer label See Label paragraph 2 Fuse sockets
34. aeees 2 see lor m AT 3 c Jj 5 General data relating to 5 Instructions relating to symbols and safety 5 Operator 6 Precautions in the event of a breakdown 7 Protection of plasma from light during and after THERAFLEX MB Plasma treatment 8 GE RTT 9 Destruction Of the 9 Declaration of conformity to the standards sese 9 Guarantee limit of responsibilities and property rights 10 Rm 10 Limit of responsibilities 11 seinieni n TTTRTRER 11 EE SC FOUN srine E R 14 Purpose Of the 14 Pace E m Tm 14 Main characteroliCS PR TEN 15 Localization of the external 16 Peripheral equipment 18 Barcode reader eee ee ee OTT 18 Barcode printer TIERE 19 POC Hi OIG Mem M RR P 19 20 UN Siar Ma D 23
35. and connector Pictures may differ from delivered equipment General data Purpose Operational Laser source Resolution Mechanical Overall dimensions Weight hand held laser scanner Red LED 610 650 nm Maximum 0 102 mm 4mils 17 x 7 1 x 6 6 mm 6 7 x 2 8 x 2 6 in 121 9 g 4 3 02 18 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Electrical Current Operating 340mA 5VDC Stand By 190mA 5VDC Input voltage 5 VDC 10 Environmental Operating temperature use in air conditioned room at 0 to 50 C 0 to 122 F Operating humidity 5 to 95 relative humidity non condensing Note for more detailed data refer to the manufacturer manual BARCODE PRINTER The barcode printer also called label printer is used to print the label with illumination result at the end of the cycle Figure7 The barcode printer Pictures may differ from delivered equipment The barcode printer must be connected to the dedicated MacoTronic B2 output See paragraph Rear side on page 16 Note for more detailed data refer to the manufacturer manual REPORT PRINTER The report printer is used to print illumination report at the end of the cycle The report printer must be connected to the dedicated MacoTronic B2 output See paragraph Rear side on page 16 Figure 8 The report printer Note for more detailed data refer to the manufacturer manual Pictures may differ from de
36. authorized temperature of the plasma bag temperature measured by the pyrometer In all cases the cycle remains valid if the required energy is delivered The warning temperature threshold of bag corresponds to a warning level When the temperature of the plasma bag measured by the pyrometer is above the programmed value an alarm occurs It is recommended to fix it at 26 C In all cases the cycle remains valid if the required energy is delivered If the temperature is exceeded during the cycle the temperature is printed in red on the report It is just a warning the plasma temperature is high and may affect the quality of the plasma but the THERAFLEX procedure 1 still valid The corrective action is to check that the machine is well located according to the user s manual recommendations And that the plasma temperature was not too high when placed within the machine Note that if the warning occurs during a cycle the maximum temperature reached during a cycle will be written in red on the report lluminaton data Source 1 Source 2 Warning temperature programmnad Maximum temperature reached t 00 1258 00 13 28 27 80 28 30 Temperature menu 83 Maximum temperature to start C Error occurs during d J PreTests Error code 3100 Figure 103 When displayed this screen indicates that the Maximum Temperature to start threshold of bag value ha
37. aximal admissible internal temperature has been reached Maximum temperature start parameter Figure 39 A Maintenance required for optical block j Current equipment Date and time Icons displayed during the illumination cycle Icon Meaning Bag fully identified and being treated or ready for treatment Bag not identified it won t be treated Bag unsuccessfully treated an error occurred during the treatment SI Bag successfully treated 46 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Starting up 47 PREPARING THE ILLUMINATION USER S IDENTIFICATION The MacoTronic B2 equipment has been switched on according to chapter Starting up on page 44 According to the MacoTronic B2 configuration see paragraph Manage user on page 80 the user can be selected on the main screen by Manual entry of the user s name and password W Scanning the user s name and password Manual entry of the user s name and password Maco 1 Touch the gt icon until your name is displayed or touch the arrows to scroll the user list up and down Figure 40 Selecting your name 2 on Touch the icon and enter the corresponding password on_ the keyboard shown on the screen Maco 3 Touch the icon 2 to display the next screen Figure 41 Entering the corresponding password 48 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b 4 The screen waits the bag code entrie
38. ble Connection of the barcode printer cable Connect the MacoTronic B2 equipment Barcode printer output to the barcode printer USB socket via an USB cable The barcode printer must be connected to the dedicated MacoTronic B2 output and through the delivered specific adapter Connection of the barcode reader cable Use this connection if the RFID reader is not used Connect the MacoTronic B2 equipment Barcode reader output to the barcode reader USB socket via the specific delivered cable The Barcode reader can be connected either on the front USB socket or on the back USB socket 40 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b The barcode reader must be connected to the dedicated MacoTronic B2 output and through the delivered specific cable POWER SUPPLY CONNECTION Connect the following power supply cables to the equipment and to the wall socket To mains socket To mains socket Report printer m MacoTronic B2 Figure 34 The MacoTronic B2 power supply connections Report printer if used W Barcode printer if used Connections 41 42 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b 43 STARTING UP BEFORE SWITCHING ON THE MACOTRONIC B2 1 Open the drawer and check that no 4 d bag has been left inside the drawer Figure a Checking of the presence of left bags S WITCHING ON THE PERIPHERAL EQUIPMENTS 1 If necessary power on the peripheral equipment s label
39. e Cannot write illumination data on the tag Consequence Error code 33XX Cycle cannot be started Corrective action Figure 137 3610 Bag one 3620 Bag two Error during check bag presence test Disable RFID functionality or replace the RFID tag Error level Warning error Error occurs Cause durin Hardware problem Consequence Error code 3XXX Cycle cannot be started Corrective action Figure 138 Contact you Macopharma representative Hardware error Error code table 2611 Bag 1 is declared but not detected 2612 Bag 2 15 declared but not detected 2621 Bag 1 is detected but not declared 2622 Bag 2 15 detected but not declared Errors and curative maintenance procedures 117 CYCLE ERRORS Cycle error occurs during the cycle and leads to an invalid treatment Bags with an invalid treatment have to be discarded All the cycle error code will be in the following range 4000 4999 Maco 17 Error code 4900 Figure139 Screen displayed after click on the stop button during an illumination cycle Error level Critical error Cause The cycle has been stopped by the user Consequence Illumination is stopped The failed source appears in red color on the screen A data back up with error code invalid treatment for every bag is carried out Corrective action Non applicable Error code 4XXX
40. eceeeesseeeeeeeeeeeessaeaeeeeesseaaaesees 39 MacoTronic B2 CAO eS uei GEDE tudin esp 40 Power supply COnnectiOnN EN E T m TT 41 AP UNE UU NOR 44 Before switching on the B2 eese nee 44 Switching on the peripheral 44 Switching on the MacoTronic 2 44 Setting the working parameters nennen nennen nennen nnns 45 Icons displayed on the 46 Preparing the Humatol f 48 User s 48 Opening the CrAWEL cccccccsseeeecccceeeeeseeceeeeeeeeeeeeeeeeeeseeeeeeeeeessaeeeueeeeeeessaaseeeeeeeeessaeses 50 Placing the plasma packs cen scccuscudevs ics censeatadastens indddennentudabd 50 Scanning the plasma packs cccccccccessseececceeseeeeeeceeeeeeeeeeeeeeeeseueeeeeeeeesssaeeeeeeeessaageses 51 NG SUNG TET 54 MUMINA OI een 56 Manual 56 Stopping aborting an illumination 59 Saving the illumination data nnne nnn nnns 60 Barcode label printing and barcode checking
41. emote control Figure128 Autotest error message 112 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Error level Critical error Cause A hardware problem has been detected Consequence The machine cannot be use Corrective action Open the drawer to check if there is nothing remaining in the machine Press the restart button If the problem persists write down date time and error code Then contact your Macopharma representative BAG DATA VALIDATION ERRORS Bag data validation error occurs just after the bag identification step An error is triggered if the bag identification data are incorrect or incoherent Bag data can be checked by the system itself by the Macotrace or by the RFID reader Depending which system trigger the error a different screen will be displayed the error code will help you to understand how to fix the problem All the bag data validation error code will be in the following range 2000 2999 If an error occurred the bag identification screen will be displayed again after error acknowledgement make sure that the data entered are correct Maco Error occurs A during bag data Error code 2500 validation Figure 129 Bag data validation error Maco Error occurs during bag data validation Error code 2XXX Figure 130 RFID bag data validation error Maco Error occurs during bag data validation Error code 2XXX Figure 131 HFI
42. equipment WORKING AREA The working area requires the presence of The MacoTronic B2 equipment m Windows PC computer the computer features are specified on page 19 On site operation 35 Laboratory The MacoTronic B2 equipment requires the following operating conditions W Controlled room temperature 20 C 2 C Ambient air humidity 80 maximum without condensation Working area Working bench it will have to support the weight of the MacoTronic B2 equipment with important safety margin In addition the surface of the working bench will have to be compatible with the used products resistance to the possible chemical aggression when cleaning etc m MacoTronic B2 equipment peripheral space will have to allow the opening of drawer as well as the access to various rear connections and the mains socket for complete switch off Thus the working area will have to be sufficiently vast to ensure a good mobility around the MacoTronic B2 equipment this is important both for the users and the ventilation of the MacoTronic B2 equipment at least 20 cm space behind m MacoTrace computer peripheral space will have to allow the use of the mouse and the keyboard in accordance with the usual ergonomic recommendations 200 mm 440 mm 470 mm 680 mm 615 mm Figure 30 The working area Power supply wall sockets The following power supply socket should be available Item Description Mac
43. er 16 Barcode cable connection 40 Barcode printer 16 40 Barcode reader 16 40 Barcode reader connection 40 Ethernet 16 40 125 Power supply connection 41 Report printer 16 40 Report printer cable connection 40 USB 16 40 125 Space Internal memory 96 USB key 96 Start after scan 90 Starting up 44 Stop button Clicked 118 119 120 Stop of illumination 27 58 59 Storage 34 Storage humidity 125 Storage temperature 125 126 Symbols Electrical 5 Heat 6 Other 6 Safety 5 Technical characteristics Barcode reader 18 Technical data 122 Temperature Bag max temperature 82 Menu 82 Storage 125 126 Too high bag setting 82 Working 125 Temperature exceeded illumination 57 Temperature management bag 125 Temperature menu Warning temperature 82 Transferring Data 96 97 Files 96 97 Translucent tray 104 Maintenance 102 104 Transport 33 Transportation 37 Type conformity certificate with EMC requirements 126 Type of equipment 17 U Unpacking 33 USB 15 Key 96 97 Key free space 96 Lateral front sockets 16 Menu 96 Rear sockets 16 Socket 16 40 125 Transfering data 97 USB front socket Localization 16 USB rear socket Localization 16 Use 42 User management Menu 80 User s identification 24 48 User s name Manual entry 24 48 Scanning entry 49 V Voltage 125 Mains 5 Voltage Rating 17 W Wave lenght 125 Weight 15 124 With
44. ey or from an USB key to the MacoTronic B2 1 Insert an USB key into one of the USB connector The USB connectors are located on the front face see Figure 3 marker 5 the rear side Figure 4 marker 6 2 Click on one or several of these 6 icons Ga 188 to select the data to be transferred The selected icon s receive s a blue background 99 3 SICK on 5 To transfer data from the MacoTronic B2 to the USB key 5 on to transfer data from the USB key to the MacoTronic B2 Figure 114 3 Check the transfer or the residual The Process menu memory with the two animated scrolls USB menu 97 DATE TIME MENU AVAILABLE FUNCTION DateTime 3 This screen is used to set the date time value and format 30 03 2012 11 54 37 Date Format Time Format 281 Figure 115 The Date Time menu when displayed Set the Date and time values W Tochange the date and time press the value that you want to change to highlight it in blue W Then press the up and down arrow to increase or decrease this value W Then press the apply button to save the modification 18 03 2012 12 12 50 98 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Change the date and time format To change the date or time format open the corresponding list by pressing the blue arrow and select the desired value This display format will be used for the right menu the
45. g screen appears during the 2 initialization procedure THERAFLEX NAB PlIosm co Lt aa ee B NL Lead the wowinBiocod Salety Figure 11 The initialization screen 5 After the initializing the login screen is displayed 6 The MacoTronic B2 equipment is ready to be used Figure 12 The login screen USER S IDENTIFICATION User selection 1 Touch the icon until your name is displayed Or touch the V icon to display all the authorized users and select your name pu 2 Touch the icon and enter the corresponding password on the keyboard shown on the screen Figure 13 3 Touch the icon 2 to display the next Selecting of the users name and password screen entry 24 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b POSITIONNING THE BAGS y 1 Open the drawer 3 2 Place the first pack in its holder and set the holder in on the left side of the drawer 3 Place the second pack in its holder and set the holder in on the right side of the drawer Figure 14 The two holders are placed in the drawer The current screen is as represented on the figure on the left Maco Product o Figure 15 The screen is waiting the Donation number scan 1 Scan the first bag Donation code 2 Scan the first bag Product code 3 Scan the first bag Lot code The second bag screen is then displayed 4 Scan the second bag
46. g up Use Software configuration Error and warning messages First step maintenance Technical data About this handbook 1 WHO IS THE READER This handbook is addressed to any professional wishing to use the present equipment HOW TO USE THIS HANDBOOK We recommend to read this handbook attentively and to apply the mentioned restrictions THE CD ROM The CD Rom contains this handbook in an electronic format pdf The reading or the impression of this handbook presented in a pdf format requires the presence on the computer of a specific reading software named Acrobat Reader and available in free remote loading on the www adobe com site MENTIONED TRADE MARKS Microsoft and Windows are registered trademarks of Microsoft Corporation in the United States and in other countries Adobe and Adobe Acrobat Reader are marks of Adobe Systems Incorporated 2 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b DELIVERED EQUIPMENT The equipment is delivered with a specific pallet together with the following parts Item Description MacoTronic B2 equipment 4 Holders Compliance certificate Power cord Hand scanner Report printer Label printer se pet CD Rom 9 User manual in english Delivered equipment 3 4 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b SAFETY GENERAL DATA RELATING TO SAFETY This MacoTronic B2 equipment complies with the Medical Device Directi
47. he MacoTronic B2 equipment to another laboratory in the event of removal or for the return of the MacoTronic B2 equipment to MacoPharma for a repair If the elimination of materials of packing is decided it will be necessary to take account of the legislation of the country and the rules of the laboratory Storage The storage of the MacoTronic B2 equipment is carried out in its packing of transport The temperature and the moisture of the storage zone must remain under normal operating conditions 10 C lt temperature lt 45 C and 10 lt moisture lt 80 The packing of transport has to be protected from any environmental risk water gas dust shock etc Displacement The MacoTronic B2 equipment can be moved from the laboratory in which it was initially installed in the case of a transfer to another laboratory or building MacoPharma is not responsible for the damage or the accidents caused by the users To take out the MacoTronic B2 equipment of the service follow the following procedure Preserve the database of the results of preceding treatments Switch the MacoTronic B2 equipment off Remove the power plug Remove the used connections Ethernet printers barcode reader Clean the internal drawer Place the wood transport casing near the MacoTronic B2 equipment Install the MacoTronic B2 equipment in the wood transport casing Place all the accessories and documents provided with the MacoTronic B2 equipment in t
48. he wood transport casing The above procedure is also applicable to dispatch the MacoTronic B2 equipment to the retailer or to the MacoPharma technical center for maintenance purpose 34 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b ON SITE PREPARATION SAFETY REQUIREMENTS MacoPharma recommends scrupulously following the rules of the company and the country in particular W Safety regulations for the users handling of the products etc The installation of an adapted laboratory ventilation reducing the local temperature MacoPharma is not responsible for problems involved in the installation by user escapes ventilation etc All actions will have to be taken in accordance with the rules of the laboratory and under the responsibility of the use EQUIPMENT TO BE PROVIDED The following equipment will be necessary for the use of the MacoTronic B2 equipment An electrical power supply 110 240 V AC 50 60 Hz 10 A earth A barcode reader A barcode printer A report printer A computer PC if the MacoTrace application is used Only the equipment listed above or any equipment provided exclusively by MacoPharma may be used The use of accessories and cables other than those specified including the maximum length for cables can involve dysfunction as well as increase in the emission of the apparatus All equipment connected to the system must be certified to IEC 950 standard or IEC ISO applicable to
49. indicator 16 Localization 16 Power rating 17 Power supply 15 Connection 41 Socket 16 Voltage 125 Wall sockets 36 Power supply mains Socket 16 Power supply failure 108 Power supply socket Localization 16 Powering Off MacoTronic B2 70 Peripheral equipments 70 Powering on MacoTronic B2 23 44 Peripheral equipments 44 Power off 29 70 Power on 23 44 Print Bag label print 87 Bar printer COM port 87 Barcode label 27 62 64 66 Menu 86 Print report 86 Print report button 86 Test 87 Print report 86 Print report button 86 Process Check bags presence 90 Menu 90 With end processus screen 91 With RFID 89 Product code 89 Product number 52 Property rights 11 Purpose of the equipment 14 Pyrometer 125 Q Quick start guide 21 R Radio frequency identification device 37 Rear side External devices 16 Report printer Connection 40 Description 19 Ethernet socket 16 Maintenance 105 Socket 16 40 Reprint 72 73 RFID 37 89 RFID bag 125 Room temperature 36 Rules Safety 5 5 Safety Blood 7 Electrical symbols 5 General rules 5 Heat symbols 6 Operator s safety 6 Other symbols 6 Requirements 35 Symbols 5 Saving illumination data 60 Scan Donation barcode 27 63 64 66 Seal 16 Localization 16 Serial number 17 Settings 74 Access to the menu 76 Menu 76 Settings menu Auto log off 81 Manage user 80 Socket Bar code printer 16 Bar code read
50. ir or the replacement of parts which are recognized defective and at the expenses of labor except transport costs and packing The replaced defective pieces become again the property of MacoPharma The repair the modification or the replacement of parts for the period of guarantee cannot cause to prolong the warranty period For this guarantee the user will have to present to MacoPharma within 15 days a complaint as well as the delivery form The repairs modifications or replacements required in consequence of the normal wear of deteriorations or accidents coming from operator s errors of defect of maintenance lack of care overloads as well as shocks falls or degradations due to the non conform use are not covered by the guarantee This guarantee will cease immediately in the event of replacement or of repair of the original parts by people not approved by MacoPharma Within the limits permitted by the applicable laws it is of express convention that the guarantee stipulated in this paragraph is the only implicit guarantee express or legal that MacoPharma concedes on the sold equipment and that except written contrary provision the purchaser gives up any action that the purchaser or his employees affiliated companies successors or dealers could have against MacoPharma his employees affiliated companies successors or dealers because of the sold materials are aimed without limitation the actions concerning the accidents
51. lasma process m The plasma bags with nvalidated treatment have to be thrown away This means that the cycle has been interrupted or a failure occurs during the cycle POWER SUPPLY FAILURE W Incase of power failure and when no UPS Uninterruptible Power Supply is installed you will find the machine in a switch off status To restart you need to push the switch on button after having removed the plasma bags remained inside the illumination chamber if not the LED autotest could failed W f power failure occurs during running cycle the bags have to be discarded no label and report will be printed or printable for those bags If power failure occurs after the end of the cycle but before the label has been printed then it will be possible to reprint this label using the reprint function as described in chapter 108 MacoTronic B2 Rev 2 User manual Ref MTCB2UME 10 b Reprint report or label on page 72 A warning message is display during autotest in case of power failure please refer to autotest error section for more details HOW TO UNDERSTAND AND HANDLE ERRORS MESSAGE The MacoTronic B2 is performing testing at various stages of its use to provide a safe treatment When the MacoTronic B2 detects an problem an unusual behavior a error code or an error screen will be display to warn the user W An error message doesn t always mean that the machine is defective or that the treatment is not correct and that
52. livered equipment Peripheral equipment 19 PC COMPUTER This PC is not mandatory It will be used to run the MacoTrace application Purpose Run the MacoTrace application if several MacoTronic B2 units are connected to a same Ethernet network Characteristics Refer to Maco Trace manual 20 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b QUICK START GUIDE 29 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b QUICK START equipment Use this chapter only after having fully read and understand this entire document MacoPharma cannot be responsible in any way for consequences of actions taken without having followed the safety procedures described in the others pages of this document BEFORE SWITCHING ON THE MACOTRONIC B2 1 Open the drawer and check that no bag has been left inside the drawer 1 This chapter named Quick start summarized the various possibilities of the 2 Close the drawer 1 Figure 9 Checking of the presence of left bags SWITCHING ON THE MACOTRONIC 2 1 2 3 Note cables are to be connected as indicated on page 39 1 Power on the peripheral equipments label printer log printer computer 2 Check that the drawer marker 2 is correctly closed 3 On the MacoTronic B2 equipment push the ON button marker 3 and release it The front lights go up blue continuous light marker 1 Figure 10 The ON switch Quick start 23 4 The initializin
53. lumination cycle Grayed button non activated function the login screen Figure Auto log off Figure 100 will not be displayed at the beginning of each illumination cycle Blue button function activated the login screen Figure or Figure 100 will be displayed at the beginning of each illumination cycle Reprint Access for user Define if the reprint button will be accessible for user Grayed button non activated function the reprint button won t be Reprint access for user accessible for user Blue button no activated function activated the reprint button will be Reprint access for user accessible for user User management menu 81 TEMPERATURE MENU The maximum temperature settings must be fixed according to the blood centre procedures The temperature setups recommended below are defined taking into account that the machine is properly installed in an air conditioned room below 21 C AVAILABLE FUNCTION E Temperature The two functions are described below Maximum temperature to start C Ea Warning temperature threshold of the bag C EN 22 0 NNI Figure 101 The Temperature menu 82 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Warning temperature threshold of bag C A Maco pu 9 2794 Figure 102 The Warning temperature threshold By clicking on the or _ buttons select the maximal
54. n process between the original and the printed label is requested at the end of the illumination see page 62 MacoPharma strongly recommends activating this barcode control function Process menu 91 DM MENU AVAILABLE FUNCTION DM This screen allows the configuration of the Macotrace Data manager With DM You can configure Mode 1 The Macotrace behavior ne o 3 O machine network configuration Subnet 55 255 255 d Gateway m mr 07 128 c SLELE Figure 111 The DM menu 92 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Macotrace behavior The with DM button activated the Macotrace functionalities please note that you have to restart the machine to finish the configuration Grayed button non activated function the Macotrace functionalities With DM are disable Blue button activated function the Macotrace functionalities are enabled The mode drop down list allows you to select what will be the behavior of the Macotrace Mode 0 The Macotrace B2 will transfer his status to the Macotrace and the illumination file will be automatically imported in the Macotrace at the end of the cycle There is no verification on the bag identification data a bag can be illuminated twice Mode 1 The Macotronic B2 will transfer his status to the Macotrace and the illumination file will be automatically imported in
55. n the figure on the left Place the bag marker D on a flat position The barcode marker A must be clearly visible for the scanning Figure 46 Positioning the bag and the holder Check the correct positioning of the tube marker A at the holder exit Figure 47 Detail of the positioning 50 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b 2 Place then the first pack and its holder on the left side of the drawer as indicated on the figure on the left Figure 48 Placing the first holder in the drawer 3 Repeat the step 1 for the second pack 4 Then place the second pack and its holder on the right side of the drawer Figure 49 Placing the second holder in the drawer SCANNING THE PLASMA PACKS Scanning can be done through the holder material 7 The screen is as represented on the figure on the left Figure 50 The screen is waiting the Donation number scan Preparing the illumination 51 Figure 51 Scanning of the first bag Product Lot Figure52 The screen is waiting the Donation number scan Donation 44026141876 Lat Figure 53 The Donation code has been scanned Maco Donation 4026141876 product EPCS Let Figure 54 The Product code has been scanned 52 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Scan the Donation code on the first bag The scree
56. n waits for the Donation number scanning If the scan is immediately erased a false entry has been detected As soon as the scan has been validated the cursor automatically jumps into the next field If the donation code is not valid the scanned data is automatically cancelled As soon as the Donation code is scanned and validated the yellow border is moved to the Product field In case of reading error click on 4 to go back to the previous field or to jump to the next one Scan the Product code on the first bag If the scan is immediately erased a false entry has been detected The cursor automatically jumps into the next field If the product code is not valid the scanned data is automatically cancelled Note the Product code field is displayed only if the corresponding parameter has been set See Options menu Product code paragraph on page 88 7 In case of reading error click on to go back to the previous field or JJ to jump to the next one P d Maco Donation i 141876 Product WBPLS Figure 55 The Lot code has been scanned Donation Product Lot Figure56 The second set of screens relating for the second bag is displayed Figure 57 The screen waits for the drawer closing Scan the Lot code first bag If the scan is immediately erased a false entry has been detected Note this
57. nce procedures 121 TECHNICAL DATA 122 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b 123 TECHNICAL DATA APPROVALS Electrical EN 61010 1 2010 Security rules for electrical apparatus for measuring safety regulation and the laboratory EMC EN 61326 1 2006 Measuring Control and Laboratory Electrical systems Class A equipment GENERAL DATA Purpose Illumination of plasma bags according the THERAFLEX MB Plasma procedure Displayed information uman machine interface 5 7 LCD touch color screen 640 x 480 pixels Other displayed data bag ID light intensity energy delivered temperature graph and progress bar Capacity Number of bags illumination of 2 bags per cycle Type of bag illumination bags according the THERAFLEX MB Plasma procedure Other Cycle time Around 15 minutes CONSTRUCTION DATA Mechanical data Casing material painted stainless steel Panel material painted polyurethane Mass 54 kg Dimensions 470 W x 680 d x 440 H mm 615 mm lt 440 mm 470 mm 424 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Electrical power supply Power supply voltage Max voltage fluctuation Frequency Protection Absorbed energy Noise level Noise level Electrical connections Mains power Ethernet USB Barcode Printer Barcode reader 110 240 VAC Automatic selection 10 96 50 60 Hz 2 x fuses FST 5 x20 mm 10 A F10AL25
58. ncy 125 Protection 125 Voltage 5 125 Maintenance Air fan 102 103 Barcode reader 105 Current 100 Current maintenance frequency 102 External parts 102 103 Internal parts 104 105 Report printer 105 Translucent tray 102 104 Manage user Settings menu 80 Index 129 Manual illumination launching 56 Manual stop of illumination 59 Manufacturer label 17 Localisation 16 Mask 88 Mass 124 Mechanical data 124 Memory Internal 96 USB key 96 Menu Access to Settings 76 Colors of the buttons 77 DAte time 98 DM 92 Maintenance 94 Options 88 Print 86 Process 90 Settings 74 76 Temperature 82 USB 96 User management 80 N Network 93 Network 93 O OFF soft button Equipment 29 70 ON button 23 44 On push button Equipment 23 Localization 16 ON push button 16 Equipment 44 Opening drawer 50 Operator Blood 7 Safety 6 Options End illumination barcode control 91 Illumination start after scan 90 Menu 88 Product code 89 With Mask 88 Others symbols Safety 6 Outputs 15 Packing content 33 Packing material 33 Password Manual entry 24 48 PC computer Description 20 Peripheral equipments Powering Off 70 Powering on 44 130 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Peripheral space 36 Place of use 14 Plasma bag Donation 52 Lot number 53 Placing 25 50 51 Product number 52 Scanning 25 52 Pollution level 125 Power cord 3 Power on
59. oTronic B2 AC power supply 1 wall socket 110 240 V 10 A earth Report printer AC power supply 1 wall socket 110 240 V 2 A earth Barcode printer AC power supply 1 wall socket 110 240 V 2 A earth PC computer AC power supply 1 wall socket 110 240 V 2 A earth PC computer screen AC power supply 1 wall socket 110 240 V 1 A earth if used Ethernet wall socket Item Description Ethernet 1 RJ45 wall socket if used 36 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Electromagnetic interference The tests carried out on this instrument demonstrate conformity with the standard EN 61326 1 2006Class A equipment These limits are conceived to ensure a reasonable protection against interferences detrimental to a general laboratory installation in a blood center not intended to be used in a residential environment Radio frequency identification device RFID When the instrument is equipped with this option it includes two integrated readers emitting 13 56 MHz Although the distance from emission is very weak a few centimeters check that there is no risk of interference with other equipment TRANSPORTATION Figure 31 Two persons are required to safely carry the machine The machine should be handled with two hands as showed on the picture and on both sides Exercise caution the equipment weight is around 54 kg The MacoTronic B2 equipment transportation sh
60. on the system will accept kind barcode format Blue button activated function the system will accept only barcode which have a format defined in the mask file 88 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Product code This option allows the activation of the line Product Code in the Bag Definition window Figure 106 Figure 107 Product Code Product Code The Product code line is activated blue color The Product code line is inactivated grey color With RFID Activated this option allows the bag identification with RFID tags Product Code With RFID With RFID Grayed button non activated function the Product number will not be asked during the bag scanning before the illumination cycle See step 2 in the Scanning the plasma packs paragraph on page 51 Blue button activated function the Product number will be asked during the bag scanning before the illumination cycle See step 2 in the Scanning the plasma packs paragraph on page 51 Grayed button non activated function the bag code must be read by MacoTronic B2 hand scanned Blue button activated function the bag code Is read by the antenna integrated in the MacoTronic B2 Any manual scan is no longer available Bag identification menu 89 PROCESS MENU AVAILABLE FUNCTION Process The function are described bellow Illumination starts after scan Check bag presence End ill
61. on the equipment will have to apply these safety S ymbols used on the equipment Electrical symbol Electric safety labels are affixed on the outside and the interior of the instrument If one of the labels is absent it will be immediately and imperatively replaced by a new identical one This symbol means Power supply to take care of risks of electrocution Triangles with yellow bottom showing the symbols of electric danger are affixed on the elements presenting a risk of electrocution This symbol means Ground of protection frame of the MacoTronic B2 equipment to be connected to the ground Safety 5 Symbol of nonspecific risk This symbol means Non specific risk These warnings draw the attention of the user to the precautions to be taken for the effective and safe use of the MacoTronic B2 equipment For example this sign indicates the possibility of an eye exposure to a strong intensity light or the possibility of wedging the fingers illumination drawer Symbols used in the handbook This symbol means Information is underlined within the use of the equipment No danger is incurred by the user if this point is not followed This symbol means High temperature Risk of scorch is incurred by the user if this point is not followed OPERATOR SAFETY Any action carried out using the MacoTronic B2 equipment is submitted to safety advices Each operator must comply with the rules of his laboratory Any ac
62. ort or during its use it must be put out of service It is necessary to make sure that it will not be used accidentally The MacoTronic B2 equipment will be repaired by authorized technicians Safety 7 PROTECTION OF PLASMA FROM LIGHT DURING AND AFTER THERAFLE X MB PLASMA TREATMENT The Instructions for use for the THERAFLEX MB Plasma systems have recently been changed Among other minor changes the following sentences were added Do not expose to light the treatment bag containing plasma and methylene blue before illumination After sampling protect the sample from the light up to the control This document describes in more detail the underlying rationale Some customers have recognized during their routine quality control that there was a variation in the fibrinogen recovery in different production facilities One of the reasons identified was a different workflow between the different centres The treatment with the THERAFLEX MB Plasma system includes the illumination with visible light This illumination process reduces the amount of some plasma factors e g functional fibrinogen Such an effect could also occur when the illumination bags with dissolved methylene blue are exposed to day light or artificial light This influence was investigated and it was shown that illumination with strong light doses sunlight 25 000 Lux for 60 min before and or after treatment could reduce functional fibrinogen by 10 14 96 Moderate ligh
63. ould be carried out by two persons On site operation 37 38 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b CONNECTIONS GENERAL CONNECTION SCHEME At the end of this chapter the MacoTronic B2 equipment will be connected to the various peripheral equipments as presented in the following figure 1 Report printer Barcode reader 1 Mains sockets Figure 32 The general connection scheme Connections 39 MACOTRONIC B2 CABLES 1 2 4 Connect the following cables onto the rear connectors of the Maco Tronic B2 1 Mains socket 2 Ethernet for the report printer if used 3 And 4 USB cable for barcode printer barcode reader if used Figure 33 The MacoTronic B2 connectors to cables Connection of the report printer cable Ethernet Use this connection if a report printer is requested Use this connection if single MacoTronic B2 equipment is used Otherwise this printer will be connected a switch connecting the printer the machines and the computer running the MacoTrace application Connect the MacoTronic B2 equipment report printer output to a report printer Ethernet socket The report printer must be connected to the dedicated MacoTronic B2 output Use this connection if several MacoTronic B2 are connected to a single computer running the MacoTrace application Connect the MacoTronic B2 equipment Ethernet output to the Ethernet network socket via a specific Ethernet ca
64. ption is called Auto Print Label and can be configure in Print section of the settings menu OPERATING MODE WITH AUTO PRINT LABEL ENABLED In this case the label is printed automatically and you just need to do the crossmatch Proceed as follows 1 A the end of the label the label for bag 1 is automatically printed 2 Stick it on bag 1 3 The label screen is displayed See figure on the left Figure68 The first label screen 62 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Figure 69 Scan of donation barcode mj Od joe it Figure 70 The first label has been scanned and printed The second label screen waits for the scanning m 0 4 44026141875 Figure 71 The two scans have been done 4 10 11 Scan the bag donation barcode of the first bag If the donation barcode is correct the data will be displayed in field one and the yellow selection rectangle moves to the second field If the donation barcode is not correct the data will be automatically erased and the yellow selection rectangle won t move Scan the printed label If the printed label barcode is correct the field background will change to green the label screen for bag two will be displayed and the label for bag 2 will be printed If the printed label barcode is correct the field background will change to red If necessary repeat the steps 3 to 6 for the second bag
65. r the selected bag 08 09 Current illumination duration minutes seconds maa Visual indicator of the current illumination duration Bag selected a Bag not selected At any moment of the cycle or after the termination it is possible to visualize the graph of the illumination cycle for the considered bag To display this graph touch the corresponding bag icon 8 Tu The displayed information is as follows Donation Scanned data Product Scanned data Lot Scanned data 23 7 C Current bag temperature 164 78 i Current bag light mW cm intensity a s o m es o c coe E cosa ccm Figure 62 120 35 J cm Current bag energy The graph screen at the end of a normally finished received illumination cycle 7 To close this graph touch the corresponding bag icon 8 If the temperature exceeds the maximum defined temperature during illumination see page 84 a warning message appears on the screen and in the report The labels will still indicate Plasma treated with MB The warning temperature threshold of bag corresponds to a warning level When the temperature of the plasma bag measured by the pyrometer is above the programmed value an alarm occurs It is recommended to fix it at 26 C In all cases the cycle remains valid if the required energy is delivered If the temperature is exceeded during the cycle the temperature is printed in red on the repo
66. ration minutes seconds Laughing icon Full dark blue visual indicator In the meantime the front light status is as follows Color Meaning Steady No illumination in progress Slow blinking Correct illumination session ending Fast blinking X Incorrect illumination Session Magenta Illumination progress n It is then possible to print the barcode labels and check the barcode Proceed as per paragraph Barcode label printing and barcode checking on page 62 Note this option should first be selected in the Option menu choice End illumination barcode control activated see page 91 STOPPING ABORTING AN ILLUMINATION CYCLE When an illumination has been launched it is possible to stop it 1 The illumination cycle being launched the screen is as on the figure on the left Maco Figure 65 The screen during an illumination cycle 2 Stop illumination cycle by touching the 74 icon Do you really wn to stop t iluminatin The screen is as the figure in the left 3 Touch EN to continue the currently paused illumination cycle Figure 66 The screen waits the operator s decision to abort the current illumination cycle In this case the screen shows the aborted icon s Touch the lll icon to follow the process 7 An interrupted cycle cannot be restarted The treatment of an in
67. re 120 Glass bottom cleaning 104 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b INTERNAL GLASS CLEANING lalb 2 1c 19 Proceed as follows 1 Remove the front panel refer to the Maintenance manual 2 Open the drawer 3 Remove the 4 screws to 19 and remove the upper front plate 2 3 Remove all the screws 3 and remove the lower front plate 4 i 2 E 122 Figure 121 Removing the front plates 4 Remove the upper marker 1 and lower marker 2 glasses and clean them 5 Remount in reverse way Figure 122 Removing the upper and lower glasses REPORT PRINTER Refer to the manufacturer manual as far as regular maintenance and troubleshooting are concerned BARCODE READER Regularly check the cleanness of the emitting glass Wipe the surface with a lint free clean cloth Refer to the manufacturer manual as far as troubleshooting is concerned Current maintenance procedures 105 ERROR MESSAGES 106 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b 107 ERRORS AND CURATIVE MAINTENANCE PROCEDURES This chapter describes the main error and their solution if exists The MacoTronic B2 automatically prints validation labels and report which indicates if the illumination cycle is correct or not Only plasma bags with MB treated plasma mention can be considered as correctly treated according to the THERAFLEX MB P
68. re 133 Screen displayed when drawer is opened Error level Warning error Cause Drawer opened Consequence Illumination cannot be started Corrective action Close the drawer Maco Error occurs during PreTests EY Error code 3100 Figure134 Machine too hot Error occurs rey m during m hi PreTest Error code 3500 Figure135 Hard drive full 116 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Error level Warning error Cause Machine temperature is higher than the threshold set in the temperature settings menu Consequence Cycle cannot be started Corrective action Adjust the threshold or wait that the machine cool down If the problem persist contact you Macopharma representative some fan might be defectives Error level Warning error Cause The hard drive is full Consequence Illumination data cannot be store therefore the cycle won t start Corrective action Backup the file through the USB menu and restart the cycle Error level Warning error Error occurs during Pretest Cause Error during check bag presence test Consequence Error code 33XX Cycle cannot be started Corrective action Figure 136 Find in the error code table the signification Error during check bag presence test of the error and the bag declaration Error level Warning error Error occurs during Pretest Caus
69. rt It is just a warning the plasma temperature is high and may affect the quality of the plasma but the THERAFLEX procedure is still valid The corrective action is to check that the machine is well located according to the user s manual recommendations And that the plasma temperature was not too high when placed within the machine Note that if the warning occurs during a cycle the maximum temperature reached during a cycle will be written in red on the report The user should analyze the amount by which the warning temperature was exceeded and determine the validity of the procedure by means of internal protocols Launching an illumination 57 7 At this step it is possible to stop or abort the current illumination cycle See page 59 4 Figure 63 The screen at the end of a normally finished illumination cycle Figure 64 The front light status steady blinking and light color are according to the illumination status In this picture the illumination is in progress 5 58 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Illumination automatically stops for each unit once the quantity of energy defined by THERAFLEX MB Plasma procedure is reached The screen shown on the left is displayed At the end of a normal illumination cycle the following icon status are 120 06 Total quantity delivered energy defined as per THERAFLEX MB Plasma procedure 11 58 Total illumination du
70. rtificate 3 Connection principle 39 Construction data 124 Cover Localization 16 Current maintenance 100 Cycle End of illumination 28 68 Launching of illumination 56 Cycle time 124 D Data of illumination 60 Data transfer 96 97 Index 127 Date of manufacturing 17 Date time Menu 98 Declaration of conformity 9 126 Delivered equipment 3 Destruction of the equipment 9 D tection invalide 111 112 Dimensions 15 124 Displacement 34 DM Menu 92 Donation Barcode 27 63 64 66 Number 52 Donation barcode Stick 63 65 66 Donation code error 112 Drawer Closing 26 54 Empty 111 Glass 104 Maintenance 102 104 Open 111 113 116 Opening 50 Translucent tray 104 E EC Certificate 126 Declaration of conformity 126 EEC 93 42 126 Electrical Consumption 15 Data 125 Safety 9 Electrical connections 125 Electrical symbols Safety 5 Electromagnetic interference 37 EMC 9 Type conformity certificate 126 Emitted wave lenght 125 EN 61326 1 126 End illumination barcode control 91 End of illumination cycle 28 68 End processus screen 91 Energy absorbed 125 Energy received 57 Equipment Air humidity temperature 36 Casing material 124 CE marking 9 17 Connection principle 39 Construction data 124 Cycle time 124 Date of manufacturing 17 Declaration of conformity 9 Delivered 3 Destruction 9 Dimensions 124 Displacement 34 Electrical data 125 Electrical safety 9
71. s 108 BU VM LS 108 Power Supply 108 How to understand and handle errors 109 111 Bag data validation errors 113 ONS NR T NOE 116 Cycle OS RN 118 WOES EE Im DaE TEE 119 Error code on illumination 121 zeige 124 POON ANG ves apne TRE TERRE ERR 124 General daid men emer 124 Construci n dala PTT E 124 Environmental data RR RR RERO 125 ARTE QT Em 127 VI MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b ABOUT THIS HANDBOOK AIM OF THIS HANDBOOK This manual is part of the accompanying documents and thus an integral part of the device lt contains the full technical specifications of the MacoTronic B2 equipment and necessary information to support the operator Before operating the user must have been trained by MacoPharma on how to use the device to achieve optimal results The device may only be operated by persons who have been trained on proper operation and handling The manual mu
72. s Follow paragraph Opening the drawer on page 50 d Maco Product Lot Figure 42 The screen waits the bag code entries Scanning the user s name 7 This procedure can be done when corresponding choice has been selected Barcode in the configuration settings In the User management menu set the Manage user choice onto Barcode choice see paragraph Manage user on page 80 1 The MacoTronic B2 screen is as shown the left figure 2 Scan your identification number amp Figure 43 The screen waits for the user s identification scanning 3 As soon as the code scanning is validated the screen waits the code entries Follow paragraph Opening the drawer on page 50 A Maco Donation Ta Product Lot Figure 44 The screen waits the bag code entries Preparing the illumination 49 OPENING THE DRAWER 1 Before opening the drawer check that there is nothing which could obstruct the movement 2 With caution open the drawer of the MacoTronic B2 using the handle on lower part of the front panel If the drawer doesn t open it means that it is automatically locked by software illumination cycle running or auto test in progress Figure 45 Opening the drawer PLACING THE PLASMA PACKS D 1 Set the pack marker C in the holder marker B as indicated o
73. s been reached or exceeded and that you cannot start the cycle until the temperature goes under the threshold 84 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b By clicking on the or _ buttons select the maximal authorized temperature inside the illumination chamber above which the illumination cycle will not start until the temperature decreases below this programmed value is recommended to set up this temperature to 24 C Temperature menu 85 PRINT MENU AVAILABLE FUNCTION X The four functions are described below ron Hen IE standard ian Bag tata rin E E fi T COM part a 4 8 Figure 104 The Print menu Print report button Define the display status of the login screen at the beginning of each illumination cycle Grayed button non activated function no report will be printed at Print Report the end of the illumination cycle Blue button activated function the report will be printed at the end of the illumination cycle Click on the button to select the type of report Standard Bag data illumination results as well as graphs are printed Simple Sole the bag data and illumination results are printed without any graphs Print report The printer selected is the windows default printer in this cas Ghostscript PDF 86 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Bag label print button Define the display status of
74. s monthly External parts monthly Internal glasses monthly Translucent frame weekly minimum Glass bottom drawer weekly minimum 102 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b FAN AIR GRIDS CLEANING Block the fan propellers with a screwdriver and blow with a compressed air small bottle office equipment furniture Never obstruct the air grids Recommended frequency once month Figure 116 Fan cleaning EXTERNAL PARTS CLEANING Cover laterals and front sides except transparent parts Use a non greasy non abrasive cleaner or warm water Dry with a lint free clean cloth Figure117 Surface cleaning Current maintenance procedures 103 LCD display and transparent parts of the front side Use a non greasy non abrasive cleaner or warm water Dry with a lint free clean cloth Take care not to let run cleaning liquid into the lower part of the LCD display Figure 118 LCD cleaning INTERNAL PARTS CLEANING Translucent plastic frame 1 Open the drawer 2 Remove the plastic frame 3 Use a non greasy non abrasive cleaner or warm water to clean the translucent tray Dry with a lint free clean cloth Figure 119 Translucent tray cleaning Drawer glass 1 Open the drawer 2 Use a non greasy non abrasive cleaner or warm water to clean the drawer glass Dry with a lint free clean cloth 3 Place the translucent frame in its notch and close the drawer Figu
75. screen is not visible as the application immediately shows the next screen In case of reading error click on 4 to go back to the revious screen Check that the first bag icon is yellow This indicates that the data has been correctly scanned and validated If no other bag is to be illuminated directly continue to step 6 For the second plasma bag proceed as per steps 1 to 4 above Touch the icon to display the next screen The waiting screen is displayed Note the drawer 1 still open as indicated by the icon Preparing the illumination 53 CLOSING THE DRAWER Figure 58 Closing the drawer Figure 59 The waiting screen with its blinking triangle 54 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b 1 Before closing the drawer check that there is nothing which could obstruct the movement 7 Check the position of the bag tubes f the scanner is connected onto the front USB connector check that the scanner cable will not obstruct the drawer closing 2 With caution close the drawer of the MacoTronic B2 using the handle on lower part of the front panel 3 The MacoTronic B2 is ready to start an illumination cycle The p icon is blinking Continue on chapter Starting an illumination on page 56 The drawer is locked and can t be manually opened due to the presence of an electromagnet To open the drawer touch the icon
76. see Figure 40 on page 48 OPERATING MODE 1 The choice screen is displayed Refer to figure on the left 2 Click on Maco gt to display donation screen and continuing another illumination cycle with new bags Proceed per paragraph Opening the drawer on page 50 close the session new user can then logged x isla Continue as per step 4 on e cnoice screen page 45 3 Open the drawer if not yet opened and remove the illuminated bags Figure 84 Extracting the bags 68 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Ending the illumination cycle 69 SWITCHING OFF SWITCHING OFF THE PERIPHERAL EQUIPMENTS 1 If necessary power off the peripheral equipment s label printer log printer PC computer SWITCHING OFF THE MACOTRONIC B2EQUIPMENT After the illumination process the MacoTronic B2 equipment should be switched off as follows 1 If the 9 icon is not displayed touch the 74 icon Figure 85 The login screen 2 Touch the 0 icon Figure 86 The OFF soft button 70 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b you really want to shutdown Macolrone J S Figure 87 The screen waits the confirmation shutdown of the 3 In the opened window touch the corresponding button No abort the shutdown procedure and return to the Donation screen Yes shuts down the
77. st also be studied carefully before attempting to operate the device The information in this document is subject to change without prior notice in order to improve reliability design and function and does not represent a commitment on the part of the manufacturer Assembly extensions adjustments modifications or repairs may only be carried out by MacoPharma or authorized personal MacoPharma produces this handbook with an aim of providing simple precise information MacoPharma cannot of this fact ensuring any responsibility for all or bad interpretation Although all the efforts were made to propose a handbook as exact as possible this last can however comprise technical inaccuracies and or typographical errors The owner of the material is held to preserve this handbook throughout all the apparatus lifespan with obligation to transmit it to the purchaser in the event of resale The recommendations relating to the declaration of conformity of the European Community to the guarantee and the field of application are also included in this handbook Any information or modification relative to this handbook will have to be addressed to MacoPharma Rue Lorthiois 59420 Mouvaux France Tel 33 0 3 20 11 84 30 Fax 33 0 3 20 11 84 04 Web site http bloodsafety macopharma com STRUCTURE OF THE HANDBOOK For an easy consultation the handbook adopts the following structure General presentation of the equipment Settin
78. steps 3 to 6 for the second bag If the procedure cannot be finished properly press the 4 icon to abort it Continue on paragraph Ending the illumination cycle on page 68 If the label hasn t been printed at the end of the cycle you can reprint it by pressing the following button 11 a Barecode label printing and checking 65 Figure 77 Bag 1 is currently processed Figure 78 Original barcode picture Figure 79 Label barcode picture gt _ 1 1 Figure 80 Yellow selection rectangle Figure 81 Reprint button X Figure 82 66 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b The bag currently processed has a dark blue background in the case bag 1 See figure on the left This image represents the bag original barcode This image represents the barcode on the illumination result label The yellow rectangle shows you which field is selected in this example you have to scan the label barcode If the barcode has not been printed you can reprint it by pressing this button If the procedure cannot be finished properly press the grey cross on the top left corner of the screen icon to abort it Barecode label printing and checking 67 ENDING THE ILLUMINATION CYCLE This screen is displayed only if the With end process screen function as been activated See paragraph With end process screen on page 91 If not the login screen is displayed
79. t doses 10 000 Lux have only a minor detrimental effect Detailed results are shown in table 1 Table 1 Reduction in functional fibrinogen under different storage conditions Condition E Condition F 0 MACOTRONIC 15 000 Lux MACOTRONIC 10 000 Lux Mean 50 Condition G Condition a 10 000 Lux MACOTRONIC 10 000 25 000 Lux MACOTRONIC Lux 25 000 Lux Mean 55 50 After 1h 8 000 Lux bag nes nae The workflow of the THERAFLEX MB Plasma procedure is dependent on the local setting of the blood bank This could lead to MB plasma containing illumination bags which are stored for a certain period of time before or after illumination because e g the Macotronic is running Consequently and in order to allow a more consistent procedure the IFU of the respective bag systems was made more precise by introducing the above mentioned sentences so that a possible influence of light would be minimized The protection of the MB plasma containing bag from light before Macotronic illumination and before Blueflex filtration can be done by one of the following measures e Putting the bags into a box e Placing the bags into a drawer e Storing the bags in a dark room A protection during the filtration steps is not necessary These instructions should also be considered for the numbered tubing segments of MB treated plasma used for quality control that should also be kept away from light 13 to 25 loss
80. terrupted cycle is not valid Any partially treated plasma is unusable Figure67 The screen waits the operator s decision Launching an illumination 59 SAVING THE ILLUMINATION DATA Once an illumination cycle is completed a file is automatically created as follows MACHINE SERIAL NUMBER DATE ILLUMINATION NUMBER FOR THE DAY MT2 For example A003001 05 03 2010 007 MT2 represents the 7 illumination carried out 5 March 2010 on the machine with serial N A003001 All saved files are stored into the equipment memory and can be downloaded by USB key on setup menu see paragraph TRANSFERRING DATA on page 97 These files are not erased after equipment switching off 60 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Launching an illumination 61 BARCODE LABEL PRINTING AND BARCODE CHECKING The barcode label printing and barcode checking screen is displayed only if this functionality has been activated Option menu choice End illumination barcode control activated see page 91 If not continue on next chapter on page 68 This step is used to crossmatch the original barcode and the one which will be printed This manipulation can avoid printing problems and allows the user to ensure that the printed label has been stuck on the right bag An option allow you to choose the label will be printed automatically or if you have to scan the original barcode to trigger the printing of the label This o
81. that the equipment should be recycled in order to preserve the environment Mandatory marking of conformity indicating that this industrial product respect the essential requirements of safety mentioned in MDD 93 42 ECC European directive X Description 17 PERIPHERAL EQUIPMENT MacoPharma may be used The use of accessories and cables other than 1 Only the equipment here listed or any equipment provided exclusively by those specified including the maximum length for cables can involve dysfunction as well as increase in the emission and or reduction in the immunity of the apparatus All equipment connected to the system must be certified to IEC 950 standards or IEC ISO applicable to equipment BARCODE READER The barcode scanner allows the user to easily target the desired barcode and complete data transmission with a simple press of a button In addition when the scanner senses a barcode the laser beam automatically switches to scan mode and activate CodeGate to ensure high speed scanning and accuracy output on front side or on back See paragraph Rear side on page 16 The barcode scanner must be connected to the dedicated MacoTronic B2 Figure 6 The barcode reader Item Description 1 Laser window aperture 2 Mode select button CodeGate button 3 Red LED scanner status 4 Cable unlocking 5 Green LED scanner status 6 Bipper adjustable tone 7 USB cable
82. the Macotrace at the end of the cycle There is verification on the bag identification data a bag cannot be illuminated twice Mode 2 The Macotronic B2 will transfer his status to the Macotrace and the illumination file will be automatically imported in the Macotrace at the end of the cycle There is verification on the bag identification data a bag cannot be illuminated if he has not been declared before in the Macotrace imported from BBIS or during sterile connection Network configuration You can configure the network settings of the Macotronic B2 from this screen The configuration will be applied during the next startup of the Macotronic B2 if the DM option is activated therefore you need to enabled the DM button and restart the machine to save the configuration IP Subnet G ateway Standard network configuration set the Macotronic on the same network as the Macotrace IP DM Enter the Macotrace IP address Please note that the software checks if the data entered are valid which means P Gateway IP DM digits must be between 0 and 254 last digit cannot be 0 E Subnet digits must be between 0 and 255 If these rules are not followed a red cross will be displayed otherwise it will be a green mark 192 168 o 1 192 168 0 1999 3 93 MAINTENANCE MENU AVAILABLE FUNCTION Prcess The function are described bellow Enable Remote Control Disable Remote Control
83. the login screen at the beginning of each illumination cycle Bag label print Grayed button non activated function no barcode label will be printed at the end of the illumination cycle Blue button activated function a barcode label will be printed at the end of the illumination cycle On this label are printed the illumination status nvalid treatment or THERAFLEXtreated Plasma the date and time of illumination the MacoTronic B2 serial number the lot number the donor code the bag location and the file name MT2 MT2 being the file extension of the MacoTronic B2 files MacoPharma recommends activating this function Bar printer COM port n By clicking on the _ buttons select the COM port on which the barcode printer is connected This is set up by the technician during the installation and may be changed if several printers are connected to the USB ports Test Print Button Pressing this button will send a print test page to the label printer Pressing this button will send a print test page to the report printer Print menu 87 BAG IDENTIFICATION MENU AVAILABLE FUNCTION Bag Identification The function are described bellow With Masks Product code With RFID Figure 105 The Bag identification menu when displayed With Mask This function enables the mask verification system for barcode format Grey button disabled functi
84. tion taken is done under the operator s responsibility and his laboratory General safety The MacoTronic B2 equipment must be installed in an aerated zone with a controlled room temperature 20 C 2 Like any device this equipment can have an electrical electronic or mechanical breakdown The manufacturer cannot be responsible of the treated products whatever they are which would be lost following this breakdown and this even during the period of guarantee The MacoTronic B2 equipment describes in this handbook is intended to be exclusively used by a personnel beforehand trained The operations of maintenance must be exclusively realized by qualified and authorized personnel For a correct and sure use as well as for all interventions of maintenance it is essential that the personnel observe the normal safety procedures Any use of the equipment contrary to that laid out in the instructions for use documentation may affect the quality of treated products and the safety of users Any use of accessories not supplied by the manufacturer may affect the quality of treated products Do not use the Macotronic B2 under dangerous atmospheric conditions or with dangerous materials which have not been designated for use with the Macotronic B2 In order to avoid risk of electrocution do not expose the unit to rain or excess moisture The machine should be used inside a building Disconnect power before general servicing Never power on
85. umination barcode control With end process screen Autoprint label Figure 108 The Process menu when displayed Illumination start after scan Allow the illumination cycle launching as soon as the scans are done and after the drawer closing Illumination starts after scan Illumination starts after scan Grayed button non activated function the illumination cycle will be launched by the user by touching the launching the icon See paragraph Manual launching on page 56 Blue button activated function the illumination cycle will be automatically launched as soon as the scans are done and after the drawer closing without touching the icon See paragraph Automatic launching Check bags presence Check the bag presence inside the drawer before authorizing an illumination cycle start Check bags presence Check bags presence Grayed button non activated function the blood bag presence is not checked before launching the illumination cycle Blue button activated function the blood bag presence is checked before launching the illumination cycle If at least one bag is missing the missing screen Erreur Source du renvoi introuvable on page Erreur Signet non d fini is displayed 90 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b With end process screen This button can be activated only if in the User management function see page 81 the Auto Log Off button has
86. ve 93 42 EEC and fulfills the requirements of standards for Electrical safety EN 61010 1 2010 and for Electromagnetic Compatibility EN 61326 1 2006 Manufactured and tested in accordance with those standards the equipment leaves the factory in perfect technical safety conditions In order to preserve these conditions and to guarantee a safe use of the equipment the user must conform to the indications and the symbols contained in this handbook Before the installation check that the mains voltage and the apparatus selected voltage coincide When the full safe use is not possible any more the MacoTronic B2 equipment must be put out of service and preserved against an accidental use The use in full safety is not guaranteed any more in the following cases The MacoTronic B2 equipment is obviously damaged E The MacoTronic B2 equipment does not work anymore m After a long storage under unfavorable storage conditions E After serious damage undergone during transport INSTRUCTIONS RELATING TO SYMBOLS AND SAFETY This paragraph details the safety symbols as well as the elementary recommendations intended to ensure the safety of the users and the maintenance technician advices The operator in charge of maintenance must have competences and the necessary information to understand the operation of an electronic device All the users will observe the rules and the security policies of their company T Any person using or intervening
87. with covering parts dismounted The button is used to turn on the machine The shutdown is carried out using a soft button displayed on the screen which will trigger the termination of the program and the extinction of the instrument within 2 minutes Never unplug by pulling out the wire Unplug the machine at the wall socket if the equipment is not to be used for a prolonged period Unplug only at the adapter point never by pulling on the cord The space behind the machine should be at least 20 cm to allow an easy unplug of the power supply cable 6 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b Do not dismantle the machine or attempt repairs Maintenance is strictly reserved for qualified personnel Periodically daily or at least once per week minimum or after each incident the operator must clean the MacoTronic B2 equipment see Current maintenance procedure Battery A contains 2 battery buttons type CR2032 Risk of explosion is given by an incorrect type Contact a qualified technician to replace it DISPOSE OF USED BATTERIES ACCORDING TO THE INSTRUCTIONS Safety related to the manipulation of blood component The users must carry protective gears adapted for operators working in laboratory safety glasses lab coat rubber gloves etc PRECAUTIONS IN THE EVENT OF A BREAKDOWN When one suspect that the MacoTronic B2 equipment is not sure any more for example because of damage undergone during transp
88. with the people damage with goods distinct 10 MacoTronic B2 Rev 2 User manual Ref MTCB2UME10 b from the object of the contract losses or consequential damages or immaterial and in particular loss of use or of profit loss of bags stored products etc The spare parts will have to be used under the operating conditions defined by MacoPharma The application of this guarantee is carried out according to the terms of the general terms of sale of MacoPharma LIMIT OF RESPONSIBILITIES In no circumstances MacoPharma could be responsible for any damage including without limitations of the damage for loss of products interruption of work loss of information defect of the MacoTronic B2 equipment or its accessories physical injuries waste of time financial loss or material or for any indirect effect or consecutive of loss occurring within the framework of use or impossibility of use of the product even if MacoPharma would have been advised such damage PROPERTY RIGHTS The integrated software in the memory of the equipment object of this handbook including the handbook and the related document there are entrusted to the user in license They are the property of MacoPharma and are protected by the author s rights all rights reserved This integrated software can function only on one equipment at the same time and can be used only on the material to which it is built in This software cannot be separated from the hardware provided

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