MacoTronic V4 User Manual English - Blood Safety
Contents
1. 27 MAINTENANCE NY GAA Mon 28 ERROR MESSAGES ERREUR SIGNET NON DEFINI GAF ANTEE eu I tc eae eee E ser CN WU NC DA 35 Ref MTC4BUME04 1 DESCRIPTION 1 1 GENERAL DESCRIPTION The MACOTRONIC is used for the illumination of plasma following the THERAFLEX MB Plasma procedure The MACOTRONIC is an illumination device with the following characteristics e Completely Computer controlled illumination process e Capacity of 4 packs per cycle e lllumination System Low pressure Sodium Vapour lamps with U shaped tube 91 W e Individual control of energy supplied by each lamp e Plasma cooled under continual agitation e Data Traceability time intensity temperature lot and donation numbers lamp control e Lid Opening Closing System Ref MICABUMEO4 Page 1 1 2 TECHNICAL SPECIFICATIONS 1 2 1 Machine Specifications MACO I RONIC Illumination device for methylene blue pathogen reduction process with THERAFLEX MB Plasma 0459 Dimensions Macotronic 94cmxBO cmx110cm width x depth x height IT with material 60cmxB cmx141cm width x depth x height Weight 280 kg Capacity 4 bags cycle Power supply 230 volts 5 50Hz 2800 watts Fuses 15 A ATM dim 10 3238 Dissipated energy 1480 watts Electrical opening closing system for the lid Illumination characteristics Light source B sodium low pressure l2. mace pi taasti yman Fi dm Hel frees ti In order to start the illumination cycle follow the steps as described in sections 5 1 to 5 3 Ref MTC4BUME04 Page 26 5 HOW TO CONSULT PREVIOUS ILLUMINATION FILES Click on the 24 icon or from the FILE menu The various saved illumination files are shown Open marine Gy Data v tj c 5 11000007 11000001 11000008 5 11000002 3 2987654 04 21 2000 000 5 1000003 5 2387654 04 21 2000 001 5 11000004 52387654 04 21 2000 002 5 11000005 5 2987654 04 21 2000 003 5 11000006 5 2987654 04 21 2000 004 Files of type MacoTronic File Cancel Select the desired file and click on the OPEN button in the dialogue box The data are automatically loaded and shown in the MACOTRONIC main window 9 8 HOW TO VIEW ILLUMINATION TUBE STATUS It is possible to view the total illumination time for each of the tubes and therefore their status In the SYSTEM menu select the SYSTEM INFORMATION icon The following dialogue box opens System Information E 4 X General Infarmatian Macatranic Serial number MD31553 Agitator state ok Source B Bk Ok H11 M5 5 46 H12 Mod 8 86 Source F b Source B b H11 Malt 8 24 11 31 5 13 Ref MTC4BUMEO4 Page 27 6 ERROR amp WARNING MESSAGES 6 1 FAILURE DURING ILLUMINATION CYCLE Rappe
3. ALL eat CR T russe pen aram L1 Ls mang mp oe cs d Puura tasca Imam i lone inan E Chan Fumie Fi pus 1 caf a fa a a nt i rug dn 015 0 00 29 mim rmprerfurs E ern Erzrrgy frm a ups PCE Zr di Dirman HH MHES i53 al Peel pwsi E LR Ref MTC4BUMEO4 Page 22 Print selected label NB All printing action will be mentioned and dated on the illumination report In the case of we use the option label re print from the Option menu the illumination report will be automatically updated and printed References number 0E1023 Illumination date 130 200 WARNING Thisilluminslioandid notfini sh correctly 11 45 Amerrerof communi cation oooured File C Arogram File Meoophe ma bBo onic Daa 11 3 2007 001 MTC n Fradud cade E T E L amp a n 1reprintedthe 11 3007 za 11 433 Inwdid compar son 9 4 SAVING ILLUMINATION FILES Once an illumination cycle is complete a file is automatically created in the following Way MACHINE SERIAL NUMBER DATE ILLUMINATION NUMMBER FOR THE DAY MTC For example 000001 05 03 2000 007 MTC represents the 7 illumination carried out on 5 March 2000 on the machine with serial N A000001 All saved files are placed within a folder
4. LZ gwenwyn 22 C mad Souce B4 Source Sauce F4 Sowce FE B Source Bt er J Y Temperature Illumination mWicm 0 000 Energy 0 000 Temcesue cH EU Duration HH MM SS 00 00 r Ref MTC4BUME04 Page 8 3 4 PLACEMENT OF PLASMA PACKS Opening and closing the lid On the front of the Macotronic are 4 buttons 2 green for opening and 2 red for closure of the lid e In order to open the lid push simultaneously on both green buttons during opening the orange light on the lid will flash e To close the lid push simultaneously on both red buttons until the lid has completely closed CAUTION e When the lid is opening or closing verify that there is no one close to the machine e Do not place hands fingers underneath the lid e Check that there are no obstructing objects under the lid Placement of plasma packs e Open the two glass panes see below Ref MTC4BUME04 Page 9 e Place each of the 4 packs on its own pr
5. PARAMETERS 11 4 2 ILUMINATION AND TEMPERATURE 5 22 12 4 3 SOFTWARE CONFIGURATION YR RR FNAN YRR FF O 13 4 3 1 User 13 4 3 2 Illumination stor 13 4 3 3 Creation of a text file ASCII for illuminations 14 2 94 sc OCI CL Oe SE NHY NND NY RF NO NR HU dU YO EE 15 4 3 5 Printing an Illumination report HNN SNP 16 4 3 6 Printing Barcode 16 4 3 7 Non authorised Barcode entry on keyboards 16 4 3 8 Definition modification of password access to the Parameters 16 2 USE THE SOFTWARE 18 5 1 DEFINITION OF DATA RELATING TO AN ILLUMINATION 18 5 2 STARTING ILLUMINA TION 19 5 3 PRINTING BARCODE LABELS 21 5 4 VERIFICATION OF BARCODE ERREUR SIGNET NON DEFINI 5 5 OF WING ILLUMINA TION FILES 25 5 6 HOW TO EDIT THE COMMENTS BOX FOR AN ILLUMINATION 25 5 7 HOW TO START A NEW ILLUMINATION 0 26 5 8 HOW TO CONSULT PREVIOUS ILLUMINATION FILES 27 Ref MTC4BUME04 5 9 HOW TO VIEW ILLUMINATION TUBE STATUS
6. Do you confirm you want to stop the illumination The failed source appears in red screen Data back up with error code invalid treatment for every bags Corrective intervention NA Communication loss Cause Communication between Macotronic and PC X WARNING Consequence This illumination has not finished correctly Illumination Stop Communication Error The failed source appears in red screen Data back up with error code invalid treatment for every bags LE Corrective intervention Check the connections Check the serial port Check the status of the cable PC Macotronic Ref MTC4BUME04 Page 30 6 1 2 Warnings Message Comment Lamp aging alarm Cause ln i The cycle duration goes beyond 30min WARNING the illumination time is more than Consequence None The cycle is validated 30 minutes If this is not an illumination with cold sources this means you will soon have to replace them mE Corrective intervention Sources replacement the warming period has to be take into account Temperature alarm Cause The temperature inside shaft s is up to 226 pee The temperature rose above 22 C during the The overtaking appears on the curves of the interface Illumination It is mentioned in the data file and on the report Nevertheless illuminated bags are considered as welle treated plasma Labels have the MB treated plasma mention Corrective in
7. Macamanic Rental member cama nium Bab Li blah ia mw Pear ie Amg r RG r FEE i Lm amm om T xin Pda Vm NR r E eee bb TT Lateef a zi Lr EI TY Ti LX ETETE EIF zm litipivain 71 NUN illmrriianiian mium 5 amp 3 peu gregis oe HFE Fur a penis Fj It is possible to visualise the graphs of each unit of tubes by clicking on the tab corresponding to the tube unit Source B t B b etc Source B t Source B b Source F Source F b Illumination data is automatically saved with a predetermined file name Serial Number of machine date illumination number MTC Cf Section 5 4 Abort Illumination Click on the STOP button to abandon an ongoing illumination cycle An interrupted cycle may not be restarted The treatment of an interrupted cycle is not valid Any partially treated plasma is unusable NOTE Temperature f the temperature exceeds the maximum defined temperature during an illumination the corresponding section of the graph is cross hatched in red Illumination is NOT stopped A warning message appears on the scree
8. be certified to IEC 950 standard or IEC ISO applicable to equipment 2 6 2 Connection of PC peripherals Keyboard Macotronic Cable connection Sr Parallel port SATO Barcode printer E iz E Barcode A d EN reader cable LE Screen connector oe 7 Barcode Label Mu TN YW Ed USB Cable HP Printer 4 Peripheral connections The PC is delivered with pre installed software as standard installation and updates are carried out by a qualified technician Ref MTC4BUMEO4 Page 7 3 STARTUP 3 1 STARTING UP THE MACOTRONIC Switch on the machine by pressing on the interrupter switch rear right of the casing 3 2 STARTING UP THE PC Ensure that the PC has power from the wall socket Verify that all peripherals are powered printers screen Power up the PC by pressing on the interrupter button on the front panel Wait for automatic launch of the MACOTRONIC software This is the default configuration 3 9 PROGRAMME LAUNCH The screen below will appear play Options System info Dire 8 Macotranlc Serial number MI 35006 Uart rrr Sha B Donabon Number Product Code Busy Lot Humber Donation Humber Product Code Bag Lit Number Shalt F Delwyn Product Code Bn Lot Humber Donahen Humber ode Bag Lit Number p Se
9. carried out except in case of emergency except by a qualified technician Before any intervention unplug the machine at the wall socket In order to open the lid manually follow these instructions Remove the panel at the rear of the machine Loosen the nuts and remove the cover in order to lift the handle of the pneumatic pump Tip the handle towards the rear to allow access to the lifting arm It is now possible to open the cover of the MACOTRONIC CAUTION Once the opening procedure is finished carefully and slowly lower the cover into a closed position once more Put back the lever and replace those parts previously removed effectively carrying out the procedure in reverse For all questions regarding maintenance please contact the after sales service by email at the following address sav equipment macopharma com or by telephone on 33 0 3 20 11 86 50 Ref MTC4BUMEO4 Page 34 8 GARANTEE The information contained in this manual is validated for the use of the MACOTRONIC MacoPharma will not be held responsible for any errors or omissions which might exist in this manual or for any consequences arriving from them MacoPharma can under no circumstances be held responsible for and damages or problems arising from the use of the apparatus in question outside the specifications laid down in this manual MacoPharma will not be held responsible for damages nor problems arising from the use of parts or accessories othe
10. gt MacoPharma MACOTRONIC V4 USER MANUAL n T MIN rs 4 cyd Wy Na in ey NE at i LES TE ARARAT EIE LE LAT Rue Lorthiois 59420 Mouvaux France Tel 33 0 3 20 11 84 30 Direct 33 0 3 20 11 86 50 Fax 33 0 3 20 11 84 04 Ref MTC4BUMEO04 CONTENTS 1 DESCHIPEIO 1 Ld GENERAL DESC IE 1 L2 TECHNICAL SPECIFICATIONS yD 1 1 2 1 Machine 5 1 PO 2 2 TNSTALE ATON GR E 3 2 1 5 3 eu UNPA SKIN oreen iE E E 3 PACKING OUST eera nbn E A 3 2 4 MACHINE 5 4 20 MWOAPBNINOSSEOURBIDYE eiae EE EN NN ite bebe FN 5 2 6 CONNECTING THE AND 7 2 6 1 Connecting the PC to the 22 2 T 2 6 2 Connection of OCCT NS 7 9 STAR UP 8 3 1 STARTING UP THE MACOTR ONNVIQ eror rotor 8 me INP THE 8 3 3 PROGRAMME LAUNCH cccccccccseececeeeceteececeeeeeceseeseeueesaeseetseeeesaeeeessneeeeas 8 3 4 PLACEMENT PLASMA PACKS uias shee ces armatur rit 9 4 SOFTWARE PARAMETERS 11 4 1 ACCESS TO
11. two nuts CAUTION Handle the glass plates with care After cleaning the two lower glass panes reposition the plates and retighten the two nuts Air Intake Grilles Never obsiruct the air intake grilles Clean these frequently to avoid blockage Suggested Frequency Once per month Laboratory temperature The MACOTRONIC has a refrigeration unit allowing regulation of its interior temperature during the illumination cycle However the MACOTRONIC system must always be used within a temperature controlled environment from 15 C to 21 C Maintenance Preventative Heplacement Lamps The MACOTRONIC equipment includes a monitoring system for the function of each amp unit This allows an illumination to be stopped in case of a large disparity between the energy delivered between lamps In case of a problem all 4 units must be replaced CAUTION Request the intervention of a qualified technician in order to replace the lamps Sensor Calibration The MACOTRONIC is equipped with 8 sensors which detect and quantify the energy delivered by each lamp These sensors are integrated with each lamp unit When the unit is replaced the sensors are provided pre calibrated Ref MTC4BUMEO4 Page 33 The units lamps sensors must be replaced every 24 moths by a qualified technician Opening the lid In case of Emergency In case of breakdown it is possible to open the cover manually CAUTION Manual opening of the lid must not be
12. a Pobail ey rnt 41 4 Lam VL anb IP INI N y yn xl ur 1 Lodi PF TE LU mcns Dp pa Wer aay eed SE ngen B Un i E Ir mm T di TE dem B DB pe tities s 006 ean ud 8 8 Ul prm F 1 a During the illumination phase the data shown on screen are kept up to date automatically The four bar charts indicate in real time the total energy delivered compared to the requested energy 180J cm Each bar represents the energy supplied by a unit of two lamps Localisation of sources B t Unit at rear of machine Back cover section Source Eb 6 nnns CEE Top lM B b Unit at rear of machine Back central E EID section Bottom D mmn KEE F t Unit at front of machine Front cover section gen Top ux F b Unit at front of machine Front central section Bottom Tempessiwe C Ref MTC4BUME04 Page 19 The TEMPERATURE field independently shows the current temperature inside the MACOTRONIC Illumination stops for each unit automatically once the energy delivered by the tube unit equals the defined quantity 180J cm The cycle is finished once the last tube switches off The following screen appears mmm E Fis s Epes
13. acotronic serial number lot number donor code bag location and file name MTC When the option automatic label printing is selected it will print directly the label without operator intervention With this mode the labels are printed sequentially 4 3 Barcode comparison This option allows checking that the user has stuck the Macotronic Label on the correct bag If this option has been validated the donor codes checking is requested for each registered bag at the previous step bags identification phase 4 3 8 Non authorised Barcode entry on keyboards When activated this option prevents the entry of barcode information by use of the keyboard The keyboard remains useable for all other applications i e text editing for comments box etc 4 3 9 Definition modification of password access to the Parameters menu Ref MTC4BUMEO4 Page 16 By default the software is delivered without a password Access to password definition is open t all at this point Access can be controlled by password which is recommended In the SYSTEM menu select the PARAMETERS option e Click on Modify Password e Enter the new password in the appropriate field e Click on OK to validate Ei Password Cancel e Confirm the password by repeating the same series of steps From this point the new password must be used each time that you wish to access the software parameters section In order to delete the s
14. ad printing the user has the possibility to re print a label by the set up Barcode Barcode matching Bag n 1 Code for bag 1 Code for macotronic label n 1 First comparison If comparison failure Ref MTC4BUMEO4 Page 21 Barcode matching Bag n 1 E X Code for bag 1 Possibility to re print the ond comparison Code for macatranic label n 1 label by a password Set up 3 comparison failures can be authorized Up to 3 the next bag label will be printed The following message appears 3 X Each failure during the barcode comparison will be mentioned on the illumination report References saia number De d T3 Wuninationdate 1127 2007 WARNING This illumination did mottinish correctly 15 4 An errarof communi cation occured File C Arogram Fileskvtasophr resvecotroni AD 11 27 DO User uw 1 cK 4 LS E Bag 1 The barcodes are differents Iriedid comparison EE NB In the menu Option a fonction re print allows to print the label followed by a new comparison window S figs fon dk T MT Lara WD a Led Fyrddau a grain Ps info Eie Lot Bi rnm zi x Dorum Fm Pnuer Bag limbs Mara bipes Tag Lar
15. amps 81 watts lamp Delivered energy 180J cm2 as per THERAFLEX procedure with individual control of energy delivered by each lamp Wave length 580nm Temperature control Integrated cooling system to maintain the temperature inside the illumination shafts Regulated temperature 18 c Programmable temperature alarm 22 c by default Bag mixing during illumination a Conditions of use 5 Air conditionned room at 21 S Process control amp Traceability 5 Displayed data Light intensity energy delivered temperature graphs amp indicator of m advancement lt Plasma ID Donor number product code lot number e lllumination report and label printing Data back up and export under ASCII files format 3 As an option process control and traceability ensured by RFID Radio Frequency Identification device Accessories incl the ref HMC4P000 Central unit keyboard screen mouse IT cart barcode reader label printer report printer le Two i Regulations y 79 Conformity MDD 93 42 EEC Pharr ma F 59420 MOUVAUX Ref MTC4BUME04 Page 1 1 1 2 PC Specification Minimal Configuration PC XT AT compatible 1 parallel port e 1 serial port RS 232 1 USB port e WINDOWS 2000 Operating System Ref MICABUMEO4 Page 2 2 INSTALLATION 2 1 INSPECTION MACOTRONIC devices are tested prior to consignment and delivery It is recommended that the state of the delivered m
16. and a password The User Identification option will now become available The user name and the password are now required in order to access the MACOTRONIC software User management 6 User Definition User name Password DK Cancel 4 3 2 Illumination History Management When the History management option is selected in SOFTWARE PARAMETERS DIALOGUE BOX a history file is automatically created for each illumination All history data is stored in a file ILLUMINATIONS DAT created in the following location C Program Files MacoPharma Macotronic At the end of an illumination cycle click on SYSTEM then on ILLUMINATION HISTORY to view the history file Ref MTC4BUME04 Page 13 Illumination History DATE 02 10 03 15 33 20 MACHINE S N gt MODAEDI FILENAME gt Macatronic AD atan 2501 0210 2003 042 MT USER NAME gt lt ORDER J cme 180 REGUL TEMP 20 00 STATUS gt Mat Ok BAG N gt 1 lt DONATION NUMBER gt lt PRODUCT CODE gt lt LOT NUMBER gt NOTE The text editor used to view the history files can read files of 32kb or less If the file exceeds 32kb only the latest illuminations are recorded 4 3 3 Creation of a text file ASCII for illuminations Energy programmed Jcr wW arning Temperature programmed Current 180 Current 220 180 Software Configuration User Identification User management barcod
17. aterial is verified in order to point out any apparent damage from transporter Setting up and use of the equipment should follow the instructions in this document stringently 2 2 UNPACKING The MACOTRONIC is packed on a special palette and covered in packing material Remove the packing material as shown below and lower the front part placing the ramps at the front of the machine Remover the harness and unlock the brakes on the wheels in front of the machine then carefully lower the machine from the palette 2 3 PACKING LIST The delivered MACOTRONIC system comprises 3 packages e MACOTRONIC Dim 108x108x130 cm mass 330 kg e Trolley Dim 65x65x135 cm mass 50 kg e PC unit printer Dim 100x50x50 cm mass 30 kg The MACOTRONIC carton contains the following pieces MACOTRONIC e PC MACOTRONIC connection cable e Frontal wheel cover to fit to the machine The PC Printer carton contains the following pieces e PC e Screen e Report printer Ref MTC4BUME04 Page 3 e Barcode label printer e Barcode reader e Documentation Certificate of conformity for the machine amp software calibration certificates for light sensors 2 4 MACHINE INSTALLATION INSTRUCTIONS WARNING Work space The MACOTRONIC must be used in a temperature regulated environment controlled to between 15 and 21 C Electrical connections Verify that the voltage of your equipment corresponds to that of the available supply 230v 50 Hz Con
18. ature energy and intensity curves of the illumination process detailed format on request 4 3 4 Product Code When this option is selected the line Product Code is activated in Bag Definition window This identification field may then be filed in Bagdefintion MET Eag definition 2 i Donation number Donation number Product code Product code Bag lot number Bag lat number Cancel Cancel Ref MTC4BUME04 Page 15 4 3 5 Printing an Illumination report If the Print Illumination Report is selected in the software parameters the report will automatically be printed as defined by default There are two printing modes Standard with graphs and Simplified without graphs If this option is not selected it is still possible to print a single report In order to do SO Select the Option PRINT PREVIEW in the FILE menu in order to view the file to be printed Click on the a icon to start printing the document or select PRINT on the FILE menu 4 3 6 Printing Barcode labels If the Label printing option is selected in the software parameters the following window will appear once illumination is finished The number of labels per bag has to be specified but except specific case this one must be 1 On this label there are the illumination status Invalid treatment or MB treated plasma the date and time of illumination M
19. e comparison lllumination report print out Standard l History management NE Product code W Automatic label print out yes no System with antena Keyboard barcode entry disabled pom Automatic sequencial identification Automatic ASCII Export Fullillumination ASCII Export Define default directores Secure a amp remtmmatemeters sereenr Modify password Cancel When the option Export ASCII automatically is selected in the SOFTWARE PARAMETERS dialogue box an ASCII format data file is automatically created for each illumination If this option is not selected an ASCII file may be created at the end of an illumination by clicking on FILE then on EXPORT ASCII FILE Click on SAVE in order to save the ASCII file to a user specified location The file is created with a TXT file extension Ref MTC4BUME04 Page 14 This file will be organized with n lines from 1 to 4 For each bag you will follow the next fields Lot number Donor code Product code Starting illumination status Ending illumination status Macotronic Serial number User s name Illumination date Illumination starting time sequential number of cycle programmed energy Bag location illumination duration maximum temperature reached The selection of the parameter Full illumination ASCII export allows the automatic creation of the ASCII file along with the points of temper
20. e illumination time of the last Source s is longer than 20 compared to the first Source switched off Since the illumination may not be homogeneous the process is stopped Replace all the Sources in order to have a correct illumination WARNING For shaft s 1 the illumination time of the last Xx Source s is longer than 50 compared to the first Source switched off Since the illumination may not be homogeneous the process is stopped Replace all the Sources in order to have a correct illumination WARNING The intensity of Source s A is lower than 50 of the maximum intensity calculated Since the illumination may not be homogeneous the process is stopped Replace all the Sources in order to have correct illumination Cause Light blinking detection ratio up to 20 between minimum and maximum illumination Consequence Illumination shutdown The failed source appears in red screen Data back up with error code invalid treatment for every bags Corrective intervention Ask to a qualified technician for lamp s replacement Cause Dispersion between tubes for one shaft maximum variance in term of illumination duration between 4 sources At the shutdown of the first lamp the maximum time is calculated according to the following formula TimeMaxlllumz Timelllum Tubeoff TimelWarmingTubeoff 1 5 Consequence Illumination stops as soon as the calculated
21. in the following location by default C Program Files MacoPharmaMAacotronic Data To update an existing file It is not possible to update existing files Files written by the software are in Read Only format An illumination file may be saved again by changing the filename for instance in order to add comments Ref MTC4BUMEO4 Page 23 Ref MICABUMEO4 Page 24 5 5 HOW TO EDIT THE COMMENTS BOX FOR AN ILLUMINATION Comments may be defined for each illumination Once comments are added through the comments editor they may be seen by means of the comments window which is attached to all illumination data Click on the icon or select the COMMENTS EDITOR in the OPTIONS menu or via the Comments button at the base of the screen TL an s mi y im rig m B ee This is the Comment Editor 71 This editor is used exactly the same way as other applications such as WordPad In order to quit the window select Close or File and Exit Ref MTC4BUMEO4 Page 25 5 6 HOW TO START A NEW ILLUMINATION NOTE It is only possible to manage one illumination at the same time In order to create a new file for a new illumination run click on the DI Icon or select the NEW option form the FILE menu The following window will appear Tomes cm Ce fgl Mas _ rw e l ES
22. inted area cf diagram below VIEW FROM ABOVE OQ OQ Interior B ie nS po dO 4 gt Packn2 555 J ay ae nid NR 999 MOOK Pack n3 aee Pack 22222 M i lt lt Interior Front face of MACOTRONIC CAUTION e Once the packs are correctly placed close the two panes e Incase of breakdown the lid may be opened This type of opening must only be carried out in an emergency by a qualified technician Cf point 6 Ref MTC4BUME04 Page 10 4 SOFTWARE PARAMETERS 4 1 ACCESS TO PARAMETERS MENU To access and modify MACOTRONIC software options select the Software Para
23. l The Macotronic system prints automatically validation labels and report that show if the illumination cycle is well done or not Only plasma bags with MB treated plasma mention can be considered as well treated according to the Theraflex process The plasma bags with invalidated treatment do not use have to be thrown away This mention means that the cycle has been interrupted a failure during the cycle cf list below A treated bag without label has to be considered as an invalidated treatment case or power outage 6 1 1 Critical error Invalid treatment Message Comment Agitating failure Cause Failure of the agitating motion or sensor WARNING Consequence This illumination has not finished correctly Illumination stop Du SOPPER nU Ln Data storage with error code invalid treatment Corrective intervention Ask to a qualified technician Lid failure Cause Lid failure Failure of the lid sensor The cover is not properly closed Consequence The illumination is not valid and is going to be Illumination stop cancelled Data storage with error code invalid treatment Corrective intervention Ask to a qualified technician Ref MTC4BUMEO4 Page 28 Message Comment Light failure Note The lamps are controlled after a warning period regarding the 8 sensors 1 photodiode for each lamp A Ref MTC4BUME04 WARNING For shaft s 1 Th
24. meters menu from the System Tab The following dialogue box below will appear A X OE omnid art bae BA mco Saco rusqu Uc Warren T emo ature programmed Gami THU 220 ihana ator dedication Mem nag he barcode companion mood miri pended 3 Product code 2 hola fd ea Leig Auth regquenci identiicahon ASCH Export Defa rn ene AELH E situe M pel dynnai gurad amri Ref MTC4BUMEO4 Page 11 4 2 ILUMINATION AND TEMPERATURE SETTINGS Erer piogaammesd Lier Winning ampera programmed E Lied Lunerd 220 rao Software M Llar Ll gad radar eee rrr compara print out Standard History management J E Panchurl once rm I amp ulomahc Babel pond pul perna Fydden yw antena Labeling 1 1 baiiia erly chested Prue fees iun ath Animali ASCI Dedine defauk clanrinnes Fulldumiohnn A51 Fwnnit cure bo parameser icreen Minky Cancel Definition of Settings The setting for illumination for
25. n and in the report The labels will still indicate Plasma treated with MB The user should analyse the amount by which the warning temperature was exceeded and determine the validity of the procedure by means of internal protocols Ref MTC4BUME04 Page 20 Viewing instantaneous illumination data Place the mouse cursor on the graph a black line appears in the position of the cursor and the appropriate values are shown on a legend on screen see below ES xit 35711 IO QUGUATE Me Dmpiwy Opos Sperm ints 7 Disaj di v w Macevonic Serial number MH SS pana Dinan Harrie Presdusct Uni Bars Lot aco a Fecuduet Conky Bina Lot Burnham lS po ep e Sj m eristan humiie educa Code fiag Lor Mantes Poaduct Coe py ps5 Hh roro tering ip 22 Sii Cae FU Thaf E Tm arw i ao nid 107178 Ipingsraturr 1 nA om Energy Jc Duration HE AEL mu FE o 3 PRINTING BARCODE LABELS amp VERFICATION OF BARCODE Following to the illumination and if the function Automatic label printing is activated the procedure is the following one Illumination Barcode Label comparison comparison report printing printing bag bag n2 If there is a comparison error scan failure or b
26. nect to the electrical supply using an EARTHED socket Installation must be carried out by a qualified technician e Place the MACOTRONIC in the designated workspace and lock the wheel brakes e Install the frontal wheel protector as shown below SSS HIGH LOW CAUTION Leave at least 30cm of free space at the rear of the machine in order to allow sufficient air circulation for correct operation of the cooling unit e Install the PC and Printer trolley and al associated parts Ref MTC4BUME04 Page 4 2 5 WARNING SECURITY e The interrupter switch D puts the system into stand by but is NOT a general power cut off switch In order to disconnect the unit from the mains supply unplug at the wall socket Never unplug by pulling on the wire e his apparatus must be connected to an earthed socket Earthing the system provides essential protection for users and the system e n order to avoid risk of electrocution do not expose the unit to rain or excess moisture e f a long period of non use is planned unplug the equipment at the wall socket Unplug the cord from the machine using the adapter unit never pull on the cord itself to unplug e Do not obstruct the air intake grill on this appara
27. r than those approved by MacoPharma Our equipment not including lamp units is guaranteed against all defects and errors of construction for one year from the date of delivery except for incorrect use negligence or incorrect maintenance and handling The return of materiel under guarantee will not be accepted except following written authorisation from the supplier Ref MTC4BUMEO4 Page 35 MacoPharma rare 59420 Mouvaux FRANCE CONFORMITY The medical device for inactivation of viruses in plasma by photo treatment with methylene THERAFLEX MB Plasma procedure conforms to the European Directive 93 42 CEE 0459 The MACOTRONIC illumination equipment conforms to the following directives and norms Directives 89 336 CEE CEM 73 23 CEE Low tension 98 37 CE Machines Norms EN 61326 1 part 1997 A1 part 1997 A2 part 2000 Measuring Control and Laboratory Electrical systems EN 61010 1 2001 2 edition Security rules for electrical apparatus for measuring regulation and the laboratory Ref MTC4BUMEO4 Page 36
28. tervention Check that the machine is well located according to the user s manual indications Cause MacoTronic E xi The temperature inside the shaft is up to the defined shaft A XX C shaft B XX C is higher than the maximum defined XX C Consequence You can The software waits the decrease of the temperature and At least one of the current shaft temperature limit 22 0 5 21 56 Wait for the temperature decrease om or Click on Cancel button or press Esc key to the illumination will be started automatically as soon as abort the temperature is under the limit Corrective intervention Check that the machine is well located according to the user s manual indications Ref MTC4BUMEO4 Page 31 6 2 OTHER ERROR MESSAGES Error Message Corrective Action MacoTronic A Invalid password Try again or click on Cancel i Barcode formats not specified Please define them in the barcode definition module Communication error Check The connections between the computer and MacaTronic unit The Maco Tronic unit is switched on Click on Retry to restart the illumination Es Annuler Barcode Formats not specified Please define them in the barcode definition module xi A The codes are differents 1 The bags have not been removed From the shafts You cannot illuminate them twice Replace
29. the THERAFLEX MB Plasma process is fixed at 180J cm Verify that the value entered is 180J cm The defined energy delivery is the sole parameter used by the system to validate or invalidate an illumination cycle Definition of maximum temperature The maximum temperature setting must be fixed at 22 C This value corresponds to a warning level Temperatures in excess of this value are noted by a cross hatched area on the illumination graphs The operator is warned that the defined temperature ha been exceeded during the illumination cycle In all cases the cycle remains valid if the required energy is delivered The state of an illumination cycle is programmed around this warning temperature and will not begin until the temperature is less than 21 5 C 226 a variability of 0 56 defined by default This variable is define d as an additional security margin against excess temperature during illumination Ref MTC4BUMEO4 Page 12 4 3 SOFTWARE CONFIGURATION 4 3 1 User Identification When this option is selected user identification is obligatory in order to allow each illumination cycle This function provides a way to define multiple users who may obtain secure access to the MACOTRONIC software by means of a password system At least one user must be defined in order for this option to become available To select this option from set up click as before on User Management and then go on to define a new user a user name
30. them by new ones and restart the illumination Ref MTC4BUME04 Enter the correct password as defined for the user cf section 4 3 1 and 4 3 9 Define the appropriate barcode format in the Definition of barcodes section cf User manual for barcode definition Communication problem between MACOTRONIC and PC Verify connections Verify serial port Verify state of the PC MACOTRONIC cable cf section 2 6 Barcode format does not correspond to the predefined format The scanned barcodes are not equivalent Verify that the label has been placed upon the correct pack Message indicates opening of the lid of the MACOTRONIC The lid was not correctly shut between the end of the last illumination and the start of the new cycle Page 32 7 MAINTENANCE When the equipment requires disassembly for repair to be carried out only by a qualified technician unplug the equipment at the wall socket first Unplug the power cable by pulling on the plug unit and never by pulling on the cable itself In order to ensure optimal system function several recommendations should be followed Regular Maintenance Cleaning of the interior and glass parts Use a non greasy non abrasive cleaning or warm water Dry with a lint free clean cloth Suggested Frequency Once per week minimum In order to gain access to the glass parts at the rear bottom of the interior pull out the 2 plates by undoing the
31. time is reached The failed source appears in red screen Data back up with error code invalid treatment for every bags Corrective intervention Ask to a qualified technician for cartridge s replacement Cause No homogeneity for a light source based on a maximum ratio between 2 lamps of a source The test is active when delivered energy reaches half of the programmed energy For each source if the ration is up to 50 the light source appears in red Consequence Illumination stop The failed source appears in red screen Data back up with error code invalid treatment for every bags Corrective intervention Ask to a qualified technician for cartridge s replacement Page 29 Cause Maximum illumination time based on a maximum duration for a cycle The maximum duration is WARNING m defined at 40 min to the max intensity Without This illumination did not finish correctly warming The intensity of at least one of the Sources was too weak Consequence Illumination stop The failed source appears in red screen Data back up with error code invalid treatment for every bags Corrective intervention Ask to a qualified technician for cartridge s replacement Message Comment Illumination stop by the operator Cause Click on the stop button Warning the illumination is going to abort The Consequence bags will be discarded Illumination Stop
32. tus e 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 e Any and all use of accessories not supplied by the manufacturer may affect the quality of treated products e Do not use the MACOTRONIC under dangerous atmospheric conditions or with dangerous materials which have not been designated for use with the MACOTRONIC Ref MTC4BUMEO4 Page 5 Guide to symbols found on the machine ATTENTION This symbol indicates the equipotential limit to which all parts of the machine are linked Alternating current This symbol indicates that the system is on standby Refer to maintenance and user notes Risk of electrocution Moving rotating part Risk of crushing OBSERVATIONS Unplug the apparatus at the wall socket if the equipment is not to be sued for a prolonged period Unplug only at the adapter point never by pulling on the cord Connect the electrical cord to the supply using an earthed wall socket Do not dismantle the machine or attempt repairs Maintenance is strictly reserved for qualified personnel JOG Ref MTC4BUME04 Page 6 2 6 CONNECTING THE PC AND PERIPHERALS 2 6 1 Connecting the PC to the MACOTRONIC Using a serial cable attach the SubD9b reference RS 232 on the MACOTRONIC to the PC serial port Important All equipment connected to the system must
33. ystem password use a blank password by entering nothing into the dialogue box Ref MTC4BUMEO4 Page 17 5 USE OF THE SOFTWARE 5 1 DEFINITION OF DATA RELATING TO AN ILLUMINATION User Identification Click on the USER input field and enter the text desired using the keyboard If the option User Identification is selected this field is automatically filled in Cf Section 4 3 1 Identification of a plasma unit In the PACKS zone click on the sguare representing the pack to identify the field opposite will be the field filled out Fur wi peers F Fill out the fields using the barcode reader and validate the entries by clicking on OK in the dialogue box Bag definition Donation number Product cade Bag lot number Ok Cancel Ref MTC4BUME04 Page 18 It is possible to erase the data and to redefine the identification of a pack by once again on the tick box representing the number of the pack to be redefined Note The Product Code function is optional and may be deactivated in the ooftware Parameters section See Section 4 3 4 5 2 STARTING AN ILLUMINATION An illumination cycle will not begin until the interior temperature of the system is correct Illumination is started by clicking on the Illumination button on the software screen see below Dues Opa Diese d 9 wj Beriah meun Md HA Bum CT oe ee Danet
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