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MYTHIC 18 - Frank`s Hospital Workshop

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1. usAcc1 ausCrc Tab1 puc Data usAcc1 4 15 usAccl gt gt 4 usAcc1 ausCrc Tab1 pucData gt gt 4 usAcc1 4 15 usAccl gt gt 4 pucData ISize return usAcc1 XOR gt gt Logical shift right logical AND Page 36 68 Copyright Orph e SA Ali Rights Reserved MYTHIC 18 6 PARTS LISTE 4 BLOW UP VIEW rer mis sM 001Revoz 6 PARTS LIST 4 BLOW UP VIEW 6 1 PARTS LIST 6 1 2 Two years spare parts kit NEN Part Number 002 1001 50 20 02 Designation Mythic 18 2 years spare parts kit Designation 3 A 002 1001 50 10 Mythic 18 O Rings kit 1 A 002 1001 5011 Mythic 18 Tubings kit 2 A 005 1001 03 03 Piston Y 22 1 A 010 2501 02 05 Sampling needle 1 A 010 2501 03 01 Piston Y 6 5 Syringes module 1 A 010 2501 03 02 Piston 16 Syringes module 6 1 2 Maintenance kit Part Number 002 1001 50 02 Designation Mythic 18 Maintenance Kit 1 B 005 100 9009 mg 1 B 005 1001 9010 m ng 5 53010110025 Cables Tieg 2 312 0505 1310 160 Gong 13 1x1 6 Fluocarbon80SH 1 312 0505 140 125 010 lO ring 14x25 Fluocarbon80SH 2 312 0505 500100 O ringg5xiFluocarbonBOSH 005 410 0501 01 Silicon M1011 grease _ 1 700 110140 Short Arm TORX T10 Tool __ 1 zoo t101 20 Short Arm TORX T20 Taal Page 37 68 Copyright Orph e SA All Rights Reserved MYTHIC 18 6 PARTS LISTE 4 BLOW UP VIEW
2. 2 205 1001 01 Mythic 18 CPU board 3 205 1001 03 Mythic 18 Preamplifier Doan 4 360 0101 030 060 Screw CZXM3x6 Zoo 5 360 0101 040 060 Screw CZXM4x6 gt 6 360 6203 040 600 Hexagonal spacer FF M4x60 8 360 0102 040 080 ScrewRLX M4 x 8 Page46 68 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18 SM 00 RevO2 PARTS LISTE amp BLOW UP VIEW 6 2 5 Front cover Module Rep Part Number Designation 1 005 1001 04 02 Front cover 2 1005 1001 84 06 170 Start key Switch MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 47 68 _REF M18 SM 001 Rev02 0 7 SOTWARE 7 SOFTWARE 7 1 INTRODUCTION Please refer to the User s Manuel for explanation of the software operation 7 2 SPECIFIC TECHNICIAN DISPLAY The following section describe the software operation which are only accessible with the technician and super technician passwords 7 2 1 Technician password The unmodified technician password is 8SUP It is strictly forbidden to disclose the technician password to the final customer In such case Orph e guarantee will not be valid 7 2 2 Technician display The technician display are accessible from MAIN SCREEN then SERVICE then TECHNICIAN 7 2 2 1 Technician allows access to the adjustment of the counting parameters and lysis quantity These adjustments are possible with the super technician co
3. BRE L MIB SM O01 Rev 02 6 1 2 O rings kit PI Part Number 002 1001 50 10 Designation Mythic 18 O Rings kit 1 312 0501 1554 262 O ring 15 54x2 62 Silicone 60SH 1 312 0501 1877178 O ring 18 77x1 78 Silicone 60SH 2 812 0501 2189 262 O ring 921 89x2 62 Silicone 60SH 1 812 0501 4734 178 Gong 247 34x178 Silicone 60SH 1 312 0501 630 240 lO ring 06 3x2 4 Silicone 60SH 1 p12 0501 635178 O ring 6 35x1 78 Silicone 60SH 1 312 0501 952 178 O ring 9 52x1 78 Silicone 60SH 248 12 0505 1310 160 O ring 13 1x1 6 Fluocarbon 80SH 312 0505 140 125 010 O ring 21 4x1 25 Fluocarbon 80SH 2 312 0505 500100 O ring 5x1 Fluocarbon 80SH 6 1 2 Tubing kit PT Part Number 002 1001 50 11 Designation Mythic 18 Tubing kit 1 1 1 B 005 1001 9007 Tubing7 1 B 005 1001 9009 Tubing9 1 B 005 1001 9010 TubingO 1 B 005 1001 9014 Tubing14 1 B 005 1001 9021 Tubing 1 B 005 1001 9023 Tubing23 DILUENT 1 B 005 101 9024 Tubing24 WASTE Page38 68 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18 SM 00 RevO2 6 PARTS LISTE amp BLOW UP VIEW 6 1 2 All spare parts Mythic 18 Spare Parts Rev 3 UNI MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 39 68 6 PARTS LISTE 4 BLOW UP VIEW Designation Piston Carriage Piston 16 010 2501 03 02 Piston 22 005 1001 03 03 Piston
4. CR MCH Value A B CR MCHC Value A B CR RDW Value A B CR PLT Value A B CR MPV Value A B CR THT Value A B CR PDW Value A B CR LYM Value A B CR MON Value A B CR GRA Value A B CR LYM Value A B CR MON Value A B CR GRA Value A B CR END RESULT Checksum value CR A and B like routine results 5 2 3 CHECKSUM For the frames with a few number of lines the block is finished with an end line with a checksum This sum is calculated from the beginning of the headline to the end of the line finishing the block The algorithm of the calculation for the sum is CRC OxFFFF For each byte Work on high neeble Indix byte XOR CRC Indix Indix AND OOOF CRC Table Indix XOR CRC divided by 16 Work on low neeble MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 35 68 B OUTPUT FORMAT REE MI8 SM 00 Rev 02 _ Indix byte divided by 16 Indix Indix XOR CRC Indix Indix AND OOOF CRC Table Indix XOR CRC divided by 16 Example in C language Hash table static const unsigned short ausCrcTab1 0x0000 OxCCO1 0xD801 0x1400 0xF001 0x3C00 0x2800 0xE401 OxAO01 0x6C00 0x7800 0xB401 0x5000 0x9C01 0x8801 0x4400 D CRC computing unsigned short calc_crc unsigned char pucData long Size 9 9 p 9 d unsigned short usAcc1 OxFFFF while ISize gt 0 d gestion par guartet du calcul
5. ORIGIN PROBLEMS SOLUTIONS YTHIC Diluent leaks around the Check the rinsing needle block presence of clots and clean needle during the run cycle it if necessary see section 9 3 2 No starting Check the power supply connection wires In any case if a problem is not solved call Orph e s All results bad Check the level diluent and if the tubing is pinched No display Check the flat cable Printer No printing Check the paper Check the electrical connection Bad printing Check the black ribbon MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 66 68 REF M18 SM 001 Rev 02 10 TROUBLESHOOTING 10 3 TROUBLESHOOTING MESSAGE This section allows to know what to do when a troubleshooting message appears on the screen MESSAGE ACTION BACKUP BAD FOLDER DUPLICATION Re start the Mythic BACKUP CALIBRATION HISTORY IS FULL Delete the calibration results BACKUP FOLDER NOT FOUND Re start the Mythic BACKUP MEMORY IS ALMOST FULL PLEASE DELETE RESULTS BACKUP NO MEMORY AVAILABLE FOR STORAGE Delete the stored results BACKUP QC HISTORY IS FULL Delete the Q C results of the ongoing lot BACKUP REPEATABILITY HISTORY IS FULL Delete the repeatability results BACKUP LAST RESULTS RESTORED COM CRC CONTROL ERROR Communication error retry Re start the Mythic INTERN COUNT ERROR Re start the Mythic INTERN MEMORY CORRUPTED Re start the Mythic INTERN NO MEMORY AVAILABLE Re start the Mythic INTERN
6. Orph e SA All Rights Reserved REF M18 SM 001 Rev 02 MYTHIC 18 REF M18 SM 001 Rev 02 6 PARTS LISTE 4 BLOW UP VIEW 6 2 BLOW UP VIEW 6 2 1 Counting Module Rep Part Number Designation 12 0505 500 100 O ring 5x1 Silicone 80SH 60 0101 030 060 Screw CZX M3 x 6 312 0505 1310 160 O ring WM13 1x1 6 Fluocarbon 80SH MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 41 68 6 PARTS LISTE 4 BLOW UP VIEW rer mis sM 001Revoz 6 2 2 Sampling Module Rep Part Number Designation 005 1001 02 01 Sampling module 005 1001 02 03 Rocker Motor 005 1001 02 02 Needle Motor 005 1001 02 04 Rinsing head 005 1001 82 880 300 Needle Optical Sensor 10 363 0201 030 080 Screw K 30 x 8 11 1360 0102 030 060 Screw RLX M3 x 6 9 COIN O1 ONA 12 360 0101 030 080 Screw CZX M3 x 8 13 1005 1001 82 880 200 Rocker Optical Sensor 14 370 4050 030 10 Anti loss washer 3 x 1 Page 42 68 CopyrightO Orph e SA All Rights Reserved MYTHIC 18 REF M18 SM 00 RevO2 PARTS LISTE amp BLOW UP VIEW 6 2 3 Syringe Module Rep Part Number Designation 1 002 1001 03 05 Syringes body 2 010 2501 0306 Seal plate 3 010 2501 0302 Piston 16 4 005 1001 0303 PPistonO22 Z 5 01
7. high normal High panic CR MPV Value A B low panic low normal high normal High panic CR THT Value A B low panic low normal high normal High panic CR PDW Value A B low panic low normal high normal High panic CR LYM Value A B low panic low normal high normal High panic CR MON Value AR low panic low normal high normal High panic CR GRA Value A B low panic low normal high normal High panic CR LYM Value A B low panic low normal high normal High panic CR MON Value A B low panic low normal high normal High panic CR GRA Value A B low panic low normal high normal High panic CR WBC CURVE Channel valuet Channel value 128 CR WBC THRESHOLDS 51 52 53 CR RBC CURVE Channel valuet Channel value 128 CR RBC THRESHOLDS S1 S2 CR PLT CURVE Channel valuet Channel value 128 CR PLT THRESHOLDS S1 CR ALARMS x x ix ix ix ix x ix ix ix x CR INTERPRETIVE WBOCy y y y y y y y y y y y CR INTERPRETIVE RBCy y y y y y y y y CR INTERPRETIVE PLT y y y y y y y y y y y y CR COMMENT RUO message if necessary END RESULT Checksum value CR MYTHIC 18 Copyright Orph e SA All Rights Reserved 5 OUTPUT FORMAT Page 31 68 B OUTPUT FORMAT REE MI8 SM 00 Rev 02 _ A None or Rejection flag B None or Dor Hor h or l or L Out of limit flags x None or Alarm y None or pathologic message S1 S2 S3 thresholds of the curves Between O and 127 This
8. RESULT AREA IS LOCKED ere performing a cycle If persisting re start LY SE ALMOST EMPTY Replace the bottle and perform a prime Lysis INIT PRINTER Switch on the printer or invalidate the printings MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 67 68 10 TROUBLESHOOTING REF M18 SM O01 Rev 02_ MESSAGE ACTION Perform an INIT MOTOR or a CONTROL CYCLE Perform an INIT MOTOR or a CONTROL CYCLE Perform an INIT MOTOR or a CONTROL CYCLE Nothing Nothing Nothing Perform a CONTROL CYCLE Re start the Mythic Re start the Mythic Re start the Mythic O PRINTER RESPONSE Switch on the printer or invalidate the printings NO PRINTER RESPONSE NO PRINTER SELECTED Switch on the printer or invalidate the printings OUT OF RANGE Modify the value RUNNING AUTO CLEANING Press OK START UP CYCLE FAILED Perform a new start up cycle START UP CYCLE NOT DONE ZI mimimimimimlimimlmim alalalalalalalalala 25 25 5 KIK KIK KI AA E ud or 0101011616 6159515 dildadagiaanizzi s PIPPIP HES da OZ m Z z ulp z lt m Z ZA S d H lajoiz ie 5 DJE i Mzimic o mi g NV mizisiuim m m o o Z mio mizz B IC dljao 2 3 6 9 9 SO D Vj Aid OQ x x 9 3 Sie Es 8 J O O O O L S S a G o o O Z Z Switch on the printer or invalidate the printings Perform a start up cycle Update the SVM software Re start the SVM This MYTHIC can not be connected to the SVM Re enter the file or confirm it m
9. SW e edes UU NP RUE Me NE MEINE 2 42 Pi die COOP SWITCH EE 3410 Tem A O REAR UE 4 SPECIFICATIONS 4 TANALYTICAL SPECIFICATIONS EEN 4 2 REAGENTS SPECIFICATIONS nn ASLIM TAT ON eta tdt titi ET ENE 5 OUTPUT FORMAT EE De L Oeneral Wl e BEE 5 2 2 VREOUBST TO SEND RESULTS EE 9 2 2 1 1 Request ro send I oret este eb e tu aea 5 2 2 1 2 ACKNOWLEDGEMENT REQUEST TO SEND RESULTS esse eee 9 2 2 1 3 ACKNOWLEDGEMENT RESULTS arido tin pe tpi ee De 2 e ROUTINERESUEVS3 a dnd oen ARE D Lee AAlabm HIS T os nO I MIR O RE RE ive TEDE D2 220 2 en ee e T RBC parhologicmessages sc esa SOR a aka Dese d PETpathologic e L De e CALIBRA TION or nn eg T E aroraa a AEE O D C OG a O OO OE OO O ONE D2 A A oat sel ode REPEATABTLLETY EE Page 6 68 Copyright Orph e SA All Rights Reserved REF M18 SM 001 Rev 02 dos 9 M 32 MYTHIC 18 REF M18 SM 001 Rev 02 A DT 35 Doe SEHECKSU Msn e ET O d eU e O RE NA 35 6 PARTS LIST 4 BLOW UP VIEW 37 O ei O A a NE E EEE EP TE M 37 OL Two years spare TEE 37 o d 2 eh le EE 37 OTZ OMA M A 38 oU RAM TTL o To KI Mc Vv 38 OL 2 Ten ele aiebat at imeem depo e estet eee eee 39 OC BEOW UP ag 41 9 2 COUR ng Module a a RC alt nd lear ses MM CN et uer 41 Ge e Sampling TT 42 ord 3 SVU IGS MOI a es inuitus ett tt E nji 43 62 4 CPU PREAMPEIFIER Module sce A MANA a ie aet DUR 46 AR As A O a 47 7 SOFTWARE 48 Fa Ee EE 48
10. Y 6 5 010 2501 03 01 Part Number Qty Pkg 010 2501 03 08 410 0503 01 005 1001 01 02 02 005 1001 02 04 005 1001 02 03 Plastic grease SPG35 RBC Counting Head Rinsing head Rocker Motor 1 1 1 1 1 1 Rocker Optical Sensor 005 1001 82 880 200 Sampling module 005 1001 02 01 Sampling needle 010 2501 02 05 Screw CBLX M2 x 10 360 0103 020 100 Screw CZX M3 x 6 360 0101 030 060 Screw CZX M3 x 8 360 0101 030 080 Screw CZX M4 x 20 360 0101 040 200 Screw CZX M4 x 6 360 0101 040 060 Screw K 30 x 10 363 0201 030 100 Screw K 30 x 8 363 0201 030 080 Screw K 40 x 10 363 0201 040 100 Screw RLX M3 x 6 360 0102 030 060 Screw RLX M4 x 8 360 0102 040 080 Seal plate 010 2501 03 06 Short Arm TORX T10 Tool 700 1101 10 Short Arm TORX T20 Tool 700 1101 20 Silent bloc M4 385 1001 04 30 Start key Switch 005 1001 84 06 170 Stepper motor cable 005 1001 80 01 220 Syringe Body 002 1001 03 05 Syringe Motor 005 1001 03 10 Syringe Motor Holder 005 1001 03 07 Syringe Optical Sensor 005 1001 82 880 250 1 UNIT Syringe Piston 1 6 005 1001 03 09 UNIT Syringe Valves Cable 005 1001 84 03 UNIT Temperature Sensor 005 1001 85 01 50 UNIT Tubing 23 DILUENT 005 1001 90 23 Tubing 24 WASTE 005 1001 90 24 Tubing Ground Cable 005 1001 84 07 150 Tygon tubing 0 8x2 4mm 300 0502 008 024 Tygon tubing 1 3x3mm 300 0502 013 030 Tygon tubing 1 6x3 2mm 300 0502 016 032 Tygon tubing 2x4mm 300 0502 020 040 WBC Counting Head 005 1001 01 02 01 UNIT Page 40 68 Copyright
11. down to the rinsing position 5 Syringe down WBC bath drain valve 1 6 Syringe up Second outside needle cleaning valve 4 Waste syringe drain valve 7 7 Syringe down WBC bath drain valve 1 8 Syringe up Waste syringe drain valve 7 WBC DILUTION 9 Needle down to the dilution position and the syringes down to prime the diluent valve 8 10 Syringe up for the WBC dilution 2 ml Diluent outside of the needle valve 4 Diluent inside the needle valve 4 5 Bubble to mix the dilution valve 1 RBC DILUTION AND LYSING 11 Syringe down no valve Drawing sample of the first dilution 20yl MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 9 68 2 FLUIDICS BEE MI8 SM O0 Rev 02 Diluent prime Vacuum prime 12 Needle up and syringe up Rocker move above the RBC bath Needle outside cleaning with diluent and waste vacuum valve 3 4 13 Needle down to the rinsing position 14 Syringe up Second outside needle cleaning valve 4 8 Lysis in the WBC bath 0 3 to 0 5ml valve 9 Bubble to mix the dilution valve 1 15 Syringe down RBC bath drain valve 2 16 Needle down to the dilution position 17 Syringe up for the RBC dilution 1 5ml Waste syringe drain valve 7 Diluent outside of the needle valve 4 8 Diluent inside the needle valve 5 Bubble to mix the dilution and diluent to rinse the counting head valve 6 10 2 MEASUREMENTS 18 Syringe down to process the vacuum counting valve 10 19 First
12. frame is available for LMG test Numeric values should be replaced by 5 plus for a out of range result or by 5 dots donor invalid results If RUO mode is not activated PCT and PDW are not transmitted 5 2 2 2 1 Alarm list S UP NOT DONE S UP FAIL QC NOT DONE QC FAIL INS M INS T INS P INS R INS H L1 L2 L3 L4 L5 R1 R2 P1 P2 P3 5 2 2 2 2 WBC pathologic alarms LEU LEU LYM gt LYM lt GRA gt GRA lt MON gt NO_INTERPRETATION Page 32 68 CopyrightO Orph e SA All Rights Reserved MYTHIC 18 REF Mis sM oo1Revo2 5 OUTPUT FORMAT 5 2 2 2 3 RBC pathologic messages ANE ERY gt MICRO MACRO MICR gt MICR gt gt MICR gt gt gt MACR gt MACR gt gt MACR gt gt gt ANIS gt ANIS gt gt ANIS HYPOCR COLDAGG NO INTERPRETATION 5 2 2 2 4 PLT pathologic messages THR THR MACROP PLTAGGR MICROC SCHIZ CELLD NO INTERPRETATION 5 2 2 3 CALIBRATION MYTHIC X Y CALIBRATION Y Calibration date calibration time LOT Expiry date Creation date Creation time X A B C D F Number of results CR WBC target value tolerance CR RBC target value tolerance CR HGB target value tolerance CR HCT target value tolerance CR PLT target value tolerance CR END CALI Checksum CR Where X User who creates the lot Y User who performs the calibration A B C D and F are the coefficient of the calibration for respectively WBC RBC HGB HCT and P
13. measurement sequences valve 10 20 Syringe up Diluent back pressure valve 4 6 21 Syringe down to perform the vacuum counting valve 10 22 Second measurement sequences valve 10 DRAIN AND RINSE BATH 22 Syringe down Cleaning the apertures valve 11 WBC bath drain valve 1 RBC bath drain valve 2 23 Syringe up RBC bath rinse diluent valve 4 Waste syringe drain valve 7 24 Needle up and syringes up for back flush valve 4 6 25 Rocker move above the WBC bath 26 Syringe up WBC bath rinse diluent valve 4 Waste syringe drain valve 7 NEEDLE BACK AND WASTE DRAIN 27 Syringe down Dry the outside of the needle valve 3 28 Rocker move in the sampling position 26 Syringe up Waste syringe drain valve 7 30 Needle down in sampling position The MYTHIC 18 is ready to perform a new analyze Page 10 68 Copyright Orph e SA All Rights Reserved MYTHIC 18 _REF M18 SM 001 Rev O2 0X FLUIDICS 2 3 FLUIDICS VIEW All the fluidics part is on the right side of the instrument and consists of only three modules Sampling module o Rocker patent pending Manages the rise and descent of the needle Syringe module patent pending consists of one block o Reagent syringes Diluent lysis sampling and air syringes o Liquid valve manifold assembly and tubing Counting chambers o WBC and RBC counting chambers and hemoglobin measurement o Liquid valve manifold assembly and tubing Sampling module S
14. o ring replacement Syringes o ring replacemen Motor screw greasing Reagents level control see User s Manual Start up see User s Manual Automatic Cleaning see User s Manual Concentrated cleaning see User s Manual Shut down see User s Manual Cover cleaning see User s Manual Piston greasing see User s Manual Needle o ring replacement see section 9 2 1 Syringes o ring replacement see section 9 4 2 Motor screw greasing This operation is described during the ORPHEE training Page 51 68 Copyright Orph e SA All Rights Reserved MYTHIC 18 8 2 CONCENTRATED CLEANING Such cleaning is necessary when MYTHIC 18 is in permanent rejection for one measured parameter Prepare a Sodium Hypochlorite solution at 12 in chloride diluted 4 times with distilled water if sodium hypochlorite is concentrated at 48 in chloride ME MEN Then press S HYDRAULICS Press E CONTROL CYCLE 7 ere Press to start the cycle drain the counting chamber Page 52 68 Copyright Orph e SA All Rights Reserved MYTHIC 18 Wait for the information window Open the door on the right side see section 1 1 3 Put 2 ml of sodium hypochlorite solution in each counting chamber Press the button in the window located in the middle of the screen MYTHIC 18 performs a maintenance cycle of the apertures followed by a stand by mode during 2 min After 2 min MYTH
15. put the MYTHIC on its left side m Remove the baths connection HGB WBC coaxial RBC coaxial and thermal captor ps Unscrew but WITHOUT dismantle them the three screws which maintain the baths module the third screw is located T behind the over flow tubing Cut the fixation ties of the tubing Disconnect the tubing from the manifold and the bath Slide up and remove the baths module NOTA Take care about the tubing reconnection if necessary cut few millimeters 2 to 3mm of tubing or exchange them REASSEMBLY PROCEDURE To reassemble the unit carry out the various operations in the opposite direction Page 56 68 CopyrightO Orph e SA All RightsReserved o MYTHIC 18 _REF M18 SM 001 Rev02 oo REPARING 9 4 SYRINGE MODULE 9 4 1 Piston greasing Perform the piston greasing as described in the User s Manual 9 4 2 O ring or piston replacement Before replacing the complete syringe module drain all the tubing Remove the diluent lysis and cleaner straw from their bottle e Perform a PRIME ALL MAIN MENU REAGENT PRIME ALL Put the syringe in lubrication position MAIN MENU SERVICE MECHANICS LUBRICATE POS Switch off the MYTHIC and disconnect the power supply Remove the Lysis and Cleaner bottle from their location Then put the MYTHIC on its left side Lift the bloc to exit the syringe pistons from the piston carriage Exchange the piston if needed MYT
16. 0 250 pi AE 250mm HOA0880 T5 1 Page 22 68 CopyrightO Orph e SA All Rights Reserved o MYTHIC 18 REF M18 SM 00 Rev 02 3 ELECTRICS amp ELECTRONICS 3 4 5 Needle optical sensor E i O e J a LG v ie z c 3 Els be E ONE Syg BE 8 s oo gl z a 2 3 E S 8 KE E R zo sa EE u lt AK E s Z le CO 4 X Soudure Thermo 2 4mm L HOA0880 T51 Attache c ble MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 23 68 REF M18 SM 001 Rev 02 3 ELECTRICS 4 ELECTRONICS 3 4 6 Syringe valve cable 0 per 100 1 500 dequmN MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 24 68 3 ELECTRICS 4 ELECTRONICS REF M18 SM 001 Rev 02 3 4 7 Counting valve cable PO por 100 17500 dJequmN Page 25 68 Copyright Orph e SA All Rights Reserved MYTHIC 18 3 ELECTRICS 4 ELECTRONICS BREL M18 SM 001 Rev 02_ 3 4 8 Start key switch AAA EE ae S z bei gt X gt o m A KS o SC D o o TE wv e o Title Number 170 mm BLACK BLACK nl MEM A Page 26 68 CopyrightO Orph e SA All Rights Reserved o MYTHIC 18 3 ELECTRICS 4 ELECTRONICS REF M18 SM 001 Rev 02 3 4 9 Fluidic door switch OLE 90 p8 1001 500 am OV 18 OV Ig Page 27 68 Copyright Orph e SA All Rights Reserved MYTHIC 18 3 ELECTRICS 4 ELECTRONICS REF mi8 SM 001Revoz 3 4 10 T
17. 0 2501 0301 PistonG6 5 6 005 1001 0309 Syringe Piston 1 6 gt gt gt 8 312 0501 2189 262 Omg 21 89x2 62 Silicone 60SH 9 312 0501 630 240 O ring 6 3x2 4 Silicone 60SH 10 312 0505 140 125 O ring 1 4x1 25 Fluocarbon 80S8H 11 010 2501 0310 O ring spacer gt gt gt 12 363 0201 030 100 Screw K 30 x 10 MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 43 68 6 PARTS LISTE 4 BLOW UP VIEW Page 44 68 Rep Part Number Designation 1 005 1001 03 10 2 360 0101 030 080 3 363 0201 030 100 4 360 0101 040 200 5 385 1001 04 30 6 005 1001 82 880 250 7 363 0201 030 080 Copyright Orph e SA All Rights Reserved REF M18 SM 001 Rev 02 MYTHIC 18 6 PARTS LISTE 4 BLOW UP VIEW REF M18 SM 001 Rev 02 pi a e A TASA ubing 26 v D D O v EE Slo O Q E S olov E S EI E DS OINI Plain washer 3 Screw CZX M3 x 8 T p A AN ec j Y Y xe j Da A 02 1001 03 05 360 0101 030 080 005 1001 90 26 005 1001 03 07 0 360 4002 030 Part Number Page 45 68 MYTHIC 18 Copyright Orph e SA All Rights Reserved 6 PARTS LISTE 4 BLOW UP VIEW rer mis sM 001Revoz 6 2 4 CPU PREAMPLIFIER Module 1 002 2001 04 Mythic 18 CPU amp Preamplifier board
18. 1 600 SJ2gW0y9 bui4uno OG 10 68 1001 G00 Josuas 2JnjoJadua ya R VO v8 1001 600 2 q02 S2AJ0A bui4uno W 022 TO 08 1001 600 2 90 4040W Jaddajs 022 TO 08 1001 600 2 q09 4040W Jaddajs URZ 088 28 1001 600 40sueg po14dQ sabuAs 002 088 281 Josuag o214d EU v8 1001 600 2 909 SIADA sabulJAs 022 10 08 1001 G00 2 q09 4040W Jaddajs 00 088 28 1001 600 Josu25 0914d0 2 P22N 04 90 v8 1001 200 YO4IMS Joop 21PINIJ 2190 40 4 219 X2 4 dovi 012 G0 TOOp 0ZT Page 19 68 Copyright Orph e SA All Rights Reserved MYTHIC 18 3 ELECTRICS 4 ELECTRONICS BREL M18 SM 001 Rev 02_ 3 4 2 Stepper motor AS an m S GE E S S E gt o oN CH o o Se o o SE wv c o C2 HR 1 2 3 4 Title Number 220 mm BLIJE ORANGE YELLOW RED EEE SSS Page 20 68 CopyrightO Orph e SA All Rights Reserved o MYTHIC 18 REF M18 SM 001 Rev 02 3 ELECTRICS amp ELECTRONICS 3 4 3 Rocker optical sensor A AA GE di 2 BLACK RED e gt E ui x E Ry S O S e o o CH o co CO o o E KO So o Title Number 200mm HOA0880 T5 1 MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 21 68 3 ELECTRICS 4 ELECTRONICS REF mi8 SM 001Revoz 3 4 4 Syringe optical sensor GE di 2 BLACK RED SYRINGE OPTICAL SENSOR 005 1001 82 88
19. 4 PA A 2 H Unscrew but WITHOUT dismantle them the two upper screws which maintain the front panel Unscrew but WITHOUT dismantle it the lower screw which maintain the front panel MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 59 68 3 REPARING BEE MI8 SM 00 Rev 02 Lift the front panel and then pull it toward the front of the instrument VERY CAREFULLY and SLOWLY push on the upper side of the connector and then push on the lower side to up the fixing system This part is VERY sensitive In case of brake the complete GUI board have to be changed VERY SLOWLY pull the flat cable outside the connector _REF M18 SM 001 Rev02 oo REPARING 9 5 2 Main board replacement NOTA Before to dismantle the main board dismantle the GUI board see section 3 4 1 VERY SLOWLY push the flat cable inside the window Remove the nine connectors located at the top of the board ol i Z Remove the baths connection HGB WBC coaxial RBC coaxial and temperature sensor MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 61 68 3 REPARING BEE MI8 SM 00 Rev 02 Remove this three screws at the back of the instrument Remove the two screws located at the hydraulics side Remove the vacuum tubing then remove the board NOTA After having performed the replacement of the board dont forget to reconnect the vacuum tubing REF M18 SM 001
20. GE OF THE METAL SHEETS AFTER HAVING DISMANTLED THE COVERS MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 3 68 REF M18 SM 001 Rev 02 This equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information listed below Guidance and manufacturer s declaration Electromagnetic immunity The MYTHIC 18 is intended for use in the electromagnetic environment specified below The customer or the user of the MYTHIC 18 should assure that it is used in such environment Immunity test IEC 60601 test level Compliance Electromagnetic environment guidance level Portable and mobile RF communications equipment should be used no closer to any part of the MYTHIC 18 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms d 1 2 P IEC 61000 4 6 150Khz to 80Mhz Radiated RF 3 Vrms d 12 P 80MHz to 800MHz IEC 61000 4 3 80Mhz to 2 5Ghz dz 2 3 P 800MHz to 2 5GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strenghts from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each freguency range Interference may occur in the vicinity of eguip
21. HIC 18 Copyright Orph e SA All Rights Reserved Page 57 68 3 REPARING BEE M18 SM 001 Rev 02 Unscrew and remove the eight screws which maintain the o ring j plate Remove the o ring plate and exchange the o rings REASSEMBLY PROCEDURE To reassemble the unit carry out the various operations in the opposite direction 9 4 3 Complete syringe module replacement Before exchanging the complete syringe module put the MYTHIC on its left side as describe above section 9 4 2 Disconnect all the valves connection Unscrew but WITHOUT dismantle them the four screws which maintain the syringe module 2 Remove the waste and diluent tubing Cut the fixation ties of the tubing Unscrew and remove the screws which maintain the ground fitting Disconnect the tubing Remove the complete syringe module NOTA Take care about the tubing reconnection if necessary cut few millimeters 2 to 4mm of tubing or exchange them Page58 68 Copyright Orph e SA All Rights Reserved o MYTHIC 18 _REF M18 SM 001 Rev02 REPARING 9 5 BOARDS REPLACEMENT THE THREE BOARDS OF THE MYTHIC 18 ARE VERY SENSITIVE TO ELECTROSTATIC DISCHARGE YOU HAVE TO USE A BODY EARTH CONNECTION TO HANDLE THE BOARDS FOR THEIR REPLACEMENT OR DISMANTLING 9 5 1 GUI board replacement e e E y bs gt Lk G y PEN E E P cc E LE DA 7 TERR Us Gong c b 4 ma SJ 8 V a Vb 77 N
22. IC 18 rinses all of the elements Operator can perform an analytic cycle Wear rubber gloves and wash hands with a disinfectant after completion of work 8 3 CLEAN OUT This procedure has to be used when the MYTHIC 18 must be transported for a long distance by car train or plane This procedure consists of cleaning the MYTHIC 18 with sodium hypochloride then rinsing it with distilled water and drying it before the transportation The clean out is accessible from MAIN SCREEN then SERVICE then TECHNICIAN CLEAN OUT Press MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 53 68 REF M18 SM 001 Rev 02 9 REPARING 9 REPAIRING For all the following operations wear rubber gloves and wash hands with a disinfectant after completion of work Be careful with the edge of the metal sheets after having dismantled of the covers 9 1 EMERGENCY STOP In case of mechanical or hydraulic problem immediately press the MYTHIC 18 will make a emergency stop After having identified the problem it is necessary to perform a Control cycle 9 2 SAMPLING MODULE 9 2 1 Needle replacement Perform needle replacement as is describe in the User s Manual 9 2 2 Complete rocker module replacement Before to replace the complete syringe module drain all the tubing Remove the diluent lysis and cleaner straw from their bottle e Perform a PRIME ALL MAIN MENU REAGENT PRIME ALL Switch off the MYTHIC and d
23. J 250mm 005 1001 90 03 01 A Tubing 3 1 IL 135mm 005 1001 90 03 02 A Tubing3 2 1 20mm LI 005 1001 90 04 01 A Tubing4 1 LL 175mm 005 1001 90 04 02 A Tubing4 2 ll fmm 005 1001 90 05 A Twingo LL amm 00510019006 A Tubig6 Onn 005 1001 90 07 B Tubng7 LL 220mm IL 005 1001 90 08 A Tubing8 em 005 1001 90 09 B Twingo J 45mm 005 1001 90 1001 B Tubing 101 8mm LI 005 1001 90 10 02 A Tubingl0 2 370mm ll ll o 005 1001 9011 A Tubingtt Ill 9mm LI 005 1001 90 12 A Tubing 12 60mm 005 1001 9013 A Tubing3 ll mm ll 005 1001 9014 B Tubingi4 Il m 005 1001 9015 A Tubing ll 100mm 005 1001 90 16 A Tubing 16 mi 130mm EE 005 1001 90 17 A Tubing 17 o 80mm 005 1001 90 18 A Tubing 18 80mm 005 1001 90 19 A Tubing LL 8Omm 005 1001 90 20 A Tubing20 Il 130mm 005 1001 9021 B Tubing21 60mm ll 005 1001 90 22 A Twing22 200mm 005 1001 9023 A Tubing 23 DILUENT 150mm 005 1001 9024 A Tubing24 WASTE 150mm 0051009025 A Tubing25 III IBB 459 005 1001 90 26 A Twing26 2 J J Binn 005 1001 90 016 Tygon Tubing L 1000mm 032 A 1 6x3 2mm 1000mm 005 1001 90 020 e en Tuba tona zum 0mm 005 1001 90 030 A m MYTHIC 18 Copyright Orph e SA All Rights Res
24. LT Follow N results which served for calibration In case of manual input of the coefficients information of the lot are empty and the number of results is null Acknowledgement of the calibration is done by the frame ACK CALI Lot A CR Where A OK or Error Code MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 33 68 5 OUTPUT FORMAT 5 2 2 3 1 Results MYTHIC X Y RESULT CR DATE dd mm yyyy CR TIME hh mm ss CR MODE CALIBRATION CR UNIT Unit CR SEG Number of sequence O CR TEST LMG CR OPERATOR login Mythic when analysis is performed CR WBC Numerical Value A B CR RBC Numerical Value A B CR HGB Numerical Value A B CR HCT Numerical Value A B CR PLT Numerical Value A B CR END RESULT Checksum value CR A and B like routine results 5 2 24 QC 5 2 2 4 1 Results MYTHIC X Y RESULT CR DATE dd mm yyyy CR TIME hh mm ss CR MODE QC CR UNIT Unit CR SEG Number of sequence O CR LOT Number of lot CR Maximum 10 characters LOT DATE Creation Dateof the lot time of creation CR EXPIRY DATE Expiry date CR USER User login who created the lot CR TEST LMG CR OPERATOR login Mythic when analysis is performed CR WBC Value A B Target tolerance Target tolerance CR RBC Value A B Target tolerance Target tolerance CR HGB Value A B Target tolerance Target tolerance CR HCT Value A B Target tolerance Targ
25. ORPHEE 19 chemin du champ des filles CH 1228 Geneva Plan les Ouates SWITZERLAND Orph e Tel 41 0 22 706 1840 Fax 41 0 22 794 4391 http www orphee medical com MYTHIC 18 SERVICE MANUAL REF M18 SM 001 Rev 02 MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 1 68 REF M18 SM 001 Rev 02 REVISIONS 19 07 04 V 0 6x Creation sa 28 02 05 de V 1 0X Update of all parts CONTACT ADDRESS MANUFACTURER C2 Diagnostics 2214 Bd de la Lironde 34397 Montpellier Cedex 5 FRANCE AUTHORIZED REPRESENTATIVE ORPHEE SA 19 chemin du champ des filles CH 1228 Geneva Plan les Ouates WORLDWIDE SWITZERLAND Tel 41 0 22 706 1840 Fax 41 0 22 794 4391 http www orphee medical com LOCAL REPRESENTATIVE Page 2 68 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18 SM 001 Rev 02 IMPORTANT SAFETY INSTRUCTIONS RISK OF DANGER Indicates a procedure to be strictly respected in order to avoid any risks for the operator user or damages on the instrument or on the guality of results Indicates that wearing gloves is mandatory before performing the described operation due to risk of contact with materials that may be infectious NOTA Indicates important additional information BEFORE TO INSTALL OR TO MAINTAIN A MYTHIC 18 YOU HAVE TO READ AND TO REFER TO THE USER S MANUAL OPERATORS MUST HAVE RECEIVED ADEQUATE TRAINING BE CAREFUL WITH THE ED
26. RANCE MYTHIC 18 CONFORMS TO THE FOLLOWING DIRECTIVE 4 STANDARDS EST CONFORME A LA DIRECTIVE ET AUX NORMES SUIVANTES DIRECTIVE STANDARDS Henri CHAMPSEIX CEO President Directeur General FormDeclar Version 04 MYTHIC 18 Copyright Orph e SA All Rights Reserved 98 79 CE IVD Medical devices IEC 60601 1 2 2001 EN 61000 3 2 EN 61000 3 3 EN 61000 4 2 95 Al 98 A2 01 EN 61000 4 3 02 EN 61000 4 4 95 A1 01 EN 61000 4 5 A1 01 EN 61000 4 6 96 A1 01 EN 61000 4 11 94 Al 01 EN 55011 Class B EN 55022 Class B IEC 61010 1 2001 IEC 61010 2 081 2001 IEC 61010 2 101 2002 JUIN 2004 Page 5 68 TABLE OF CONTENTS 1 INTRODUCTION 2 FLUIDICS ed GENERALE A VERNA Mm 2 2 FLUTDICS SEQUENCES DESCRIPTION anni lotta ce E dida CAN Ia VIEW a den ete et ll one 2A FLUIDICS PARTS DESCRIPTION EE 2 4 5anipling Modules us Re ois tala NU nes 22 COUNTING DAT module alas 24 3 SYriInges module O NN 2O FLUIDICS DIAGRAM EE e 5l oeneral Le 2 5 2 Manifold tubing POSITION il AAA dd 20 5 TZEOULENGTH EE 3 ELECTRIC amp ELECTRONIC SEINE RAIL TIE M S 3 2 ELECTRICS PARTS VIEW ti nds O WE 3L Z GUT d A AI ME A A A NE PA RE RE RE 9 2 3 Pream pli ier e lis 5 24 Power supply DIR da EE ee cel zade vas ds 34 WIRINGDIACR A Mestalla KK eT EE 342 Stebber MOTOR E SR We Te EE 344 e Geh dE 3 4 5 Needle d E 94 0 Syringe ValVe Caleta riadas 34 7 COUNTING Valve Cable AAA 3418 le KEY
27. Rev 02 9 REPARING 9 5 3 Main board 9 5 3 1 Fuse replacement This fuse protects the 24v circuit Remove the fuse with a thin pliers and replace it by a new one Use a Littelfuse NANO Slo Blo fuse model 0454 004 to replace the old one It s strictly forbidden to use an another type of fuse d This battery is only used to supply the real time clock With a screwdriver lift the clips maintaining the battery Slip down the battery to remove it and replace it by a new one Use a Maxell battery model CR2016 to replace the old one kel B 8 a v sa f S y E k m A II ET D s gt It s strictly forbidden to use an another type of battery PEA We kilo Cf z CR READ CAREFULLY THE FOLLOWING RECOMMENDATIONS Handling storage Never expose the battery to ultrasonic sound Exposing the battery to ultrasonic sound may cause short circuiting because the inside material is broken into pieces leading to distortion leakage overheating explosion or fire Never subject the battery to severe shock Dropping throwing or stomping on the battery may cause distortion leakage overheating explosion or fire MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 63 68 3 REPARING REF M18 SM 001 Rev 02 _ Never short circuit the battery while installing into equipment Please be careful when installing the battery not to short circuit it with metal portions of the equipm
28. Vie PECIFIC TECHNICIAN DESPLA Y gie 48 eL Tecnnician DOSSWORG DEE 48 TeL a gf allel ee ee A NE MA O O A A et o ab 48 EE ee EE 48 Teee COUNTING PATONES nn AR 49 AA ds E 49 RE SOSIWAREAPBORESCENCES li eee 50 8 MAINTENANCE 51 BA MAINTENANCE ABE ee ee chia a A ae ca ea nea oa aed ee ben Ea o1 8 2 el E EE 52 B CEAR ai da a O O TON 53 9 REPAIRING 54 Ez ccce E 54 9 2 SAMPLING MODULE t 54 9 2 UNecaje replace meh E 54 9 2 2 Complete rocker module 1 ee a 54 QS COUNTING BATHS MODULE asin 56 AA A O LUE niet 56 9 2 Bars 0 UG E 56 95 S Apenjure block MED ACCME INN sci cence a a e dan el o tute pud 56 9 3 4 Complete baths module replacement nn ee Ata iet oie ere Rene nus 56 TA NA II IA Un delle E 97 9 TL PISTON QI COSI EE 57 O e tt ture p me 57 9 4 3 Complete syringe module replocement coco coran A 58 Ge E E 59 S9 OVE board pe NACE GE 59 95 2 Main board Tepla ement E 61 ELERS MAN OO afa ERR A IN ER CE EO AE A O OE AR AE ER NI 63 Beete ee 63 95 22 A AAA E ee ee 63 954 Preamplifier Doard e ee T EE 65 10 TROUBLESHOOTING 66 Hare in mare Nec Micenas rta a EO ER UIDE ats 66 JO OTHER PE E H 66 10 35 TROUBLESHOOTING MESSAGE arcadas 67 MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 7 68 1 INTRODUCTION rr DEE M1B SM 001 Rev 02 1 INTRODUCTION BEFORE TO INSTALL OR TO MAINTAIN A MYTHIC 18 YOU HAVE TO READ AND TO REFER TO THE USER S MANUAL The following c
29. anual connection on the SVM Westgard alarm SVM COM TIME OUT SVM UNMATCH SVM WG SVM XB XB alarm Re start the Mythic Re start the Mythic Re start the Mythic Replace the bottle and perform a prime Cleaner Replace the container and perform a prime Diluent Replace the bottle and perform a prime Lysis Ln OU Ln LD Ln SITIO ajaja a mjmimjujujo clolalalala Z dlle lel 101010 H w mn IP III SIS IS me gt Bemici m O z S G gt Z 0 ME O mId3 9 dli CH Ololclici2i m X u d ninimim mizix A O C ololiBli gt la H Z E r gt el IN KO O qQjejeo mdsz Z CIS m Z 1 S lolo CRE E Amm S N fT g E mm Replace the waste container Page 68 68 Copyright Orph e SA All Rights Reserved MYTHIC 18
30. coded in UTF8 non Latin languages management 5 2 2 FRAMES 5 2 2 1 REQUEST TO SEND RESULTS Mythic sends results after acknowledgement by the host Frames used in Hand Shake mode 5 2 2 1 1 Request to send results MYTHIC X Y RESULT READY Size CR 5 2 2 1 2 ACKNOWLEDGEMENT REQUEST TO SEND RESULTS ACK RESULT READY CR 5 2 2 1 3 ACKNOWLEDGEMENT RESULTS ACK_RESULT A B CR Where A OK or Error Code B Reserved MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 30 68 REF M18 SM 001 Rev 02 5 2 2 2 ROUTINE RESULTS MYTHIC X Y RESULT CR DATE jj mm aaaa CR TIME hh mm ss CR MODE NORMAL CR UNIT Unit CR 0 1 ou 2 SEQ Sequence number O CR SID Sample Identification CR PID Patient Identification CR ID Identification CR TYPE Blood Type CR TEST Run Test CR OPERATOR login Mythic when analysis is performed CR WBC Value A B low panic low normal high normal High panic CR RBC Value A B low panic low normal high normal High panic CR HGB Value A B low panic low normal high normal High panic CR HCT Value AR low panic low normal high normal High panic CR MCV Value A B low panic low normal high normal High panic CR MCH Value AR low panic low normal high normal High panic CR MCHC Value A B low panic low normal high normal High panic CR RDW Value A B low panic low normal high normal High panic CR PLT Value A B low panic low normal
31. de only Ee For an access to the latex adjustment and HGB blanc adjustment press CO OFF allows to test the aperture current CLEAN OUT ctm an PA LOG INTERUENTION EES Lut to fil up the leg accessible from the MAIN MENU CLEAN OUT MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 48 68 _REF M18 S5M 001 Rev02 0 7 SOTWARE 7 2 2 2 Counting parameters The modification of one of these parameters must be done in compliance with Orph e after having performed a specific training In this case of modification without authorization Orph e guarantee will not be The access of this display is available with the super technician password BLANK HGE only WEC GAIN REC GAIN PLT GAIN The twenty types of blood can be changed and selected with the type STANDARD _ STANDARD windows THRES NEL WIDTH WEC This display enables to modify the HGB WBC RBC and PLT gain located in THRES REL WIDTH REC the upper window and the counting pulse parameters in the lower window THRES PLT L 4 e In case of using a different lysis the lysis guantity can be modified in the PLT OFFSET 48 LYSE pL lowest window located on the right 7 2 2 3 Prod adjust The modification of one of these parameters must be done in compliance with Orph e after having performed a specific training In this case of modification without authorization Orph e guarantee will not be Not available manufactu
32. e the reagents to drain the baths to do the vacuum necessary for counting and to push the waste to the waste container It is made with a manifold maintaining the fluid commutation valves and with the syringes bloc including five syringes The sampling syringe The lysis syringe The two waste and vacuum pressure syringes And the diluent syringe Only one motor drives the five syringes The diluent input and the waste output are also included in this manifold Page 12 68 CopyrightO Orph e SA All Rights Reserved MYTHIC 18 2 FLUIDICS REF M18 SM 001 Rev 02 2 5 FLUIDICS DIAGRAM 2 5 1 General Diagram C Page 13 68 JSAl YINVI19 Copyright Orph e SA All Rights Reserved YOSNAS JYASSIYA MYTHIC 18 E FLUIDICS REF MI8 SM 00 Rev 02 2 5 2 Manifold tubing position Each figure corresponds to a tubing number see the Fluidic diagram section 2 5 1 Counting manifold Syringe body Page 14 68 CopyrightO Orph e SA All Rights Reserved MYTHIC 18 _REF M18 SM 001 Rev 02 E FLUIDICS 2 6 SIZE amp LENGTH TUBING To ensure perfect results it is mandatory to respect the size and the length of the tubing Tygon Tygon Tygon Tygon Tygon Tygon tubing tubing tubing tubing tubing tubing 0 8x2 4mm 1 3x3mm 1 6x3 2mm 2x4mm 3x6mm 5x8mm Part Number REV Designation ae EN aaa Pi 005 1001 90 0101 A Tubing il 1 82mm ll 005 1001 90 0102 A Tubing 1 2 180mm 005 1001 9002 A Twing2
33. emperature sensor 50mm AAA PHR 4 Grey 2 Black 3 White 4 Title Temperature Sensor ize Numbei05 1 001 85 He i ion A Approval by OMONNIER e 3 x Thermo diam 1 6mm x 10mm Thermo diam 12mm x 20mm Voul GND Vs AAA EE CH Page 28 68 CopyrightO Orph e SA All Rights Reserved o MYTHIC 18 4 SPECIFICATIONS 4 1 ANALYTICAL SPECIFICATIONS Refer to the User Manual 4 2 REAGENTS SPECIFICATIONS Refer to the User Manual 4 3 LIMITATIONS Refer to the User Manual Page 29 68 Copyright Orph e SA All RightsReserved MYTHIC 18 REF Mis sM oo1Revo2 5 OUTPUT FORMAT 5 OUTPUT FORMAT The choice of the setting format speed is explained in page N 24 of the User s Manual 5 2 C2 FORMAT 5 2 1 General principle Mythic begins frame with headline MYTHIC X Y Z eventual parameters CR Where X is the number of the Mythic maximum 2 characters Y is the user identification login maximum 10 characters Z frame identification The decimal separator is the dot The field separator is The line separator and the indicator of end is CR The uncut frame are Request of results send with send results Send calibration pack with results of calibration All the lines of a frame must be sent If no information the parameter is not fulfilled All the identifiant frame or parameters are in block letters All editable text field Identification lot are
34. ent Use the correct battery suitable for the equipment The battery may not be suitable for the specific equipment due to the using conditions or type of equipment Please select the suitable battery according to the handling instructions of the equipment Never use or leave the battery in a hot place such as under the direct rays of the sun or in a car in hot weather If you do this may cause distortion leakage overheating explosion or fire Never allow the battery to come in contact with water If it does this may cause the battery to rust or lead to distortion leakage overheating explosion or fire Never store the battery in a hot and highly humid environment Doing so may cause the performance of the battery to deteriorate In certain environments this may lead to distortion leakage overheating explosion or fire Disposal The battery may be regulated by national or local regulation Please follow the instructions of proper regulation As electric capacity is left in a discarded battery and it comes into contact with other metals it could lead to distortion leakage overheating or explosion so make sure to cover the and terminals with friction tape or some other insulator before disposal Page 64 68 Copyright Orph e SA All Rights Reserved MYTHIC 18 _REF M18 SM O01Rev02 o REPARING 9 5 4 Preamplifier board replacement NOTA Before to dismantle the preamplifier board dismantle the Main b
35. erved Page 15 68 4 SPECIFICATIONS REF MI8 SMOOLReVO2 3 ELECTRIC 4 ELECTRONIC 3 1 GENERALITIES Only three boards compose the MYTHIC 18 the main board the preamplifier board and the GUI board In the case of replacement of the main board or preamplifier board be aware of the sensibility of this board to the electrical static discharge ESD Before operating check the earth connection and use the antistatic bag supply with the board Please contact your Orph e for more information Be careful with the edge of the metal sheets after having dismantled the covers 3 2 ELECTRICS PARTS VIEW 3 2 1 Main board t SCH z mmm mt a cf Zei The mono electronic board is located between the hydraulic part and the reagent tray The board driven by a 32 bit processor manages the following parts Sample needle rocker syringe block motors Display and keyboard Connexion mode RS232 Ethernet Printer Measurement Counting hemoglobin measurement Data processing External barcode reader Page 16 68 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18 SM 001 Rev 02 oms 3 ELECTRICS amp ELECTRONICS 3 2 2 GUI board 3 2 3 Preamplifier board T EE m de 1 UL LLL MADE IH TA WAN AC ADAPTER CINCON ELECTRONICS COLTO MODEL ra7oaza TEXTE INPUT 100 240V 1 55 50 60Hz OUTPUT 24V 3 04 CAUTION For wrn
36. et tolerance CR MCV Value A B Target tolerance Target tolerance CR MCH Value A B Target tolerance Target tolerance CR MCHC Value A B Target tolerance Target tolerance CR RDW Value A B Target tolerance Target tolerance CR PLT Value A B Target tolerance Target tolerance CR MPV Value A B Target tolerance Target tolerance CR THT Value A B Target tolerance Target tolerance CR PDW Value A B Target tolerance Target tolerance CR LYM Value A B Target tolerance Target tolerance CR MON Value A B Target tolerance Target tolerance CR GRA Value A B Target tolerance Target tolerance CR LYM Value A B Target tolerance Target tolerance CR MON Value A B Target tolerance Target tolerance CR Page 34 68 Copyright Orph e SA All Rights Reserved REF M18 SM 001 Rev 02 MYTHIC 18 REF M18 SM 001 Rev 02 5 OUTPUT FORMAT GRA Value A B Target tolerance Target tolerance CR END RESULT Cheksum value CR A and B like routine results 5 2 2 5 REPEATABILITY 5 2 2 5 1 Results MYTHIC X Y RESULT CR DATE dd mm yyyy CR TIME hh mm ss CR MODE REPEATABILITY CR UNIT Unit CR SEG Number of sequence O CR TEST LMG CR OPERATOR login Mythic when analysis is performed CR WBC Value A B CR RBC Value A B CR HGB Value A B CR HCT Value A B CR MCV Value A B
37. hapters describe the different technical parts of the MYTHIC 18 Fluidic Electric 4 electronic Technical specification Output format Spare parts list and blowup view Maintenance procedure Page 8 68 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18 SM 001 Rev 02 E FLUIDICS 2 FLUIDICS 2 1 GENERALITIES MYTHIC 18 is a fully automated analyzer performing hematological analysis on whole blood The human blood venous sample must be collected in an EDTA K3 Ethylene Diamine Tetracetic Acid tri potassic tube in sufficient guantity The LMG results are available for six hours after the blood draw The use of EDTA K2 leads to a poor guality level of the LMG results It must be correctly homogenized before analysis It is recommended to use a rotary agitator turning between 20 to 30 turns mn during 10 minutes A volume of insufficient blood for the guantity of anticoagulant or a bad mixing may involve an erroneous result Two dilution rate are performed 1 237 to 1 257 for WBC HB depend of the lysis quantity see section 7 2 2 2 1 15000 for RBC PLT 2 2 FLUIDICS SEQUENCES DESCRIPTION SAMPLING SEQUENCE 1 Syringes down no valve Less than 9 8 pl of blood sample are draw inside the sampling needle Diluent prime Vacuum prime 2 Needle up and syringe up valve 3 4 Needle outside cleaning with diluent and waste vacuum 3 Rocker move above the WBC bath and the syringes up to drain the waste valve 7 4 Needle
38. isconnect the power supply Remove the Lysis and Cleaner bottle from their location Remove the upper cover three screws from the MYTHIC Page 54 68 Copyright Orph e SA All Rights Reserved MYTHIC 18 _REF M18 SM 001 Rev02 o REPARING Unscrew the rocker fixation screw but DO NOT remove it Unscrew and remove the screw which maintain the IR barrier Disconnect the three tubing and cut the ties Unscrew the two guide screw but DO NOT remove it Then slide down the guide Remove the complete rocker module REASSEMBLY PROCEDURE To reassemble the unit carry out the various operations in the opposite direction MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 55 68 3 REPARING BEE M18 SM 001 Rev 02 9 3 COUNTING BATHS MODULE 9 3 1 Baths dismantling Perform baths dismantling as described in the User s Manual 9 3 2 Baths o ring replacement Perform baths o ring replacement as described in the User s Manual 9 3 3 Aperture block replacement Perform aperture block replacement as described in the User s Manual 9 3 4 Complete baths module replacement Before to replace the complete syringe module drain all the tubing Remove the diluent lysis and cleaner straw from their bottle e Perform a PRIME ALL MAIN MENU REAGENT PRIME ALL Switch off the MYTHIC and disconnect the power supply Remove the Lysis and Cleaner bottle from their location Then
39. ment marked with the following symbol Dol NOTE 1 At 80Mhz and 800MHz the higher frequency range apllies NOTE 2 Theses guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strenghts from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM an FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should considered If the measured field strenght in the location in which the MYTHIC 18 is used exceeds the applicable RF compliance level above the MYTHIC 18 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the MYTHIC 18 Over the frequency range 150KHz to 80MHz field strenghts should be less than 3V m Page 4 68 CopyrightO Orph e SA All Rights Reserved MYTHIC 18 REF M18 SM 001 Rev 02 DIAGNOSTICS WE THE MANUFACTURER NOUS LE FABRICANT NAME NOM ADDRESS ADRESSE DECLARE THAT THE PRODUCT DECLARONS QUE LE PRODUIT NAME OF THE MODEL NOM DU MODEL DECLARATION OF CONFORMITY DECLARATION DE CONFORMITE C2 DIAGNOSTICS Parc Agropolis IT B timent 14 2214 bd de la Lironde 34397 MONTPELLIER CEDEX 5 F
40. oard see section 5 2 1 Remove the two screws located on the copper side Remove the preamplifier box from the main board To reassemble the part carry out the various operations in the opposite direction MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 65 68 REF M18 SM 001 Rev 02 10 TROUBLESHOOTING 10 TROUBLESHOOTING A 10 1 ANALYTICAL PROBLEMS PARAMETERS PROBLEMS CONDITIONS SOLUTIONS WBC No results No HGB Check the bath wires Check the lysis level Check the right lysis tubing connection to the WBC bath HGB OK Check the bath wires Perform a Cleaning Cycle and then a Bleach cycle if unsuccessful Bad stability Perform a Back flush and a Cleaning Cycle and thena Bleach cycle if unsuccessful Check the level bubble flow in the WBC bath during the run cycle Check the lysis quantity see section 7 2 2 2 No results No HCT amp PLT Check the bath wires Perform a Cleaning Cycle and then a Bleach cycle if unsuccessful Bad stability HCT 4 PLT too Performa Back flush and a Cleaning Cycle and then a Bleach cycle if unsuccessful Check the level bubble flow in the RBC bath during the run cycle Check the level bubble flow in the WBC bath during the first dilution No results Check theledlighton o Bad stability Check if no bubble in the lysis tubing Check the level bubble flow in the WBC bath during the run cycle Check the lysis quantity see section 7 2 2 2 10 2 OTHER PROBLEMS
41. ring parameters allows to adjust the HGB blanc level allows to adjust the WBC gain with the use of special latex allows to adjust the RBC and PLT gain with the use of PLT GAIN special latex particles AUTO WALID Wi RUTO Tag means that the adjustments are automatically done MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 49 68 _T _SOTWARE JE M18 SM 001 Rev 02 7 2 SOFTWARE ARBORESCENCE START UP N Launch new menu Blank Cycle m Launch Mechanical action SHUT DOWN Entry menus End of day Cycle V View Results E Runs for calibration S Runs for checking ER UD RS SERVICES SS CONTROL CYCLE MOTOR INIT SSHYDEAUEICS SS SSSMECHANIGSS Y REPEATABILITY dd EE eee Se N GE CHECK ROCKER EXI TAK CHECK SENSORS RUSE WYN SSOBERATORTQG BUT SS NEEDLE CLEAN OUT S Ee EN KE E RR RS RR ES PRIME ALL NESS S N Launch new menu Launch Mechanical action N Entry menus V View Results Page 50 68 CopyrightO Orph e SA All Rights Reserved o MYTHIC 18 8 MAINTENANCE The quality of the results and the reliability of the MYTHIC 18 are directly linked to the strict respect of the maintenance hereafter described MAINTENANCE DAILY WEEKLY MONTHLY MONTHLY HALF A YEAR ANNUALLY ser Tres ose Tech use ren user res fur ra Lo p NI NI ee ri t Piston greasing Needle
42. wilh Inbarmatian Tee hina logy Eguipin eri FOR INOS USE ONLY S N 70240 0055024 MYTHIC 18 is supplied with an external power supply block In case of replacement of the main power wire supplied with the MYTHIC 18 the new one must comply with the local regulation The MYTHIC 18 has been certified with the power supply box provided with the machine The use of another external power supply box is not guaranteed Please contact Orphee MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 17 68 REF M18 SM 001 Rev 02 3 ELECTRICS 4 ELECTRONICS 3 3 ELECTRONIC DIAGRAM F0 0 V ARTAN 1 DIHLAN FER sm reem A Enver A AA RI PENSA Od OV AT 3 E OdAFt HO LdV V AHMOd l l jeno SHALHAANO EE SWHATHd AE X HA TVAOHLJATA NOLLVOINQWINOO AS 30 28 8 TOVLIOA TUALYGaY e O E O i W074 N3320W 7 SE J j Ee TOULNOD AHONSN qum cm aS Ind 300 32018 TIGIAN l 1907 ONISSIJONA ASNA SE DEA ONISSIJONA IS TA 28M ig 320 Id NTH AS Y zm om om cm mm bes zs 4 pe IC DAY Wd TOWING CHVOTAIN AY IdSIG WIVOS 49 VAHALNI MESA quvodg ndo quvod Waa Td YA Md MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 18 68 3 ELECTRICS 4 ELECTRONICS REF M18 SM 001 Rev 02 3 4 WIRING DIAGRAM 3 4 1 General view TO 10 100
43. yringe Module Counting module MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 11 68 2 FLUIDICS REF MI8 SM O0 Rev 02_ 2 4 FLUIDICS PARTS DESCRIPTION The hydraulic part of the MYTHIC 18 is very simple and made of only three modules Sampling module Counting bath module Syringes module The modules are connected together by semi rigid tubing 2 4 1 Sampling module This module patent pending enables to draw the sample and to perform the WBC and RBC PLT dilutions It is assembled with a rotating rocker moving around a support which maintains the system to move up and down the sampling needle A very reliable system of rack gear moves the rocker The cleaning system of the sampling needle can be removed without tool see section 9 3 2 in the user manual The o ring of the needle included in the cleaning system can also be removed without tool see section 9 3 2 in the user manual The maintenance of these parts is very easy to perform 2 4 2 Counting bath module This module allows to count the WBC and RBC PLA and to measure the HGB It is made with a manifold maintaining the reagent commutation valves and the counting bath block with their measurement block including the apertures The counting bath block assembly and these apertures can be removed without tool see section 9 3 3 4 5 in the user manual 2 4 3 Syringes module This module patent pending enables to draw the sample to distribut

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