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Orphee Mythic 18 Hematology Analyzer

1. d O0 IO 0 0 0 0 0 6e 0 o 0 o In this menu the user can modify the calibration factors without any calibration with calibration blood The modification of any of these factors without running a calibration blood could affect the quality of the result Page 30 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 3 INSTRUMENT SET UP 3 4 6 Other Setting DELAY ms SHUT DOWN mn NEEDLE UP mn v VALID RUTOCLERN CLERN FREQUENCV Run Nb In DELAY box the user can modify o Time in minutes to start the automatic shut down o Time in minutes to build up the needle o setting up of the automatic cleaning and its frequency in number of analysis Reagent checking enables the reagent control see section 1 5 2 Pressure checking enables the pressure control during a measurement cycle see section 9 6 AM PM mode enables to display the time of your choice BIOLOGIST PASSWORD 177 enables to modify the biologist password REAGENT CHECKING 7 PRESSURE CHECKING AM PM MODE BIOLOGIST PASSWORD DATE FORMAT a OD HM YY DATE FORMAT enables to select the date format Once modifications are done press _vau to validate or 52 to exit without any modification 3 4 7 Storage options E RESULTS OPTION THUMB DRIVE OPTIONS REAL TIME RUNS SAVE
2. 54 84 REPEATABILITY The key Se allows having access to the repeatability display This screen allows carrying out a test of repeatability on all the parameters measured by the MYTHIC 18 Present the sample under the sampling needle and press in the trigger located behind the needle The cycle LED located at the top of the needle flickers alternatively of red with green when it becomes red the tube can be removed Repeat the operation as many times as desired maximum 20 runs The results are progressively sent on line in the table Statistical calculations are automatically carried out with each run The cursor located between the two tables enables to send the other results the results of statistical calculations move at the same time The column allows to validate or to unselect a result The key allows carrying out the following actions o Print the table o Send the results o Delete the results Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 7 CALIBRATION 7 CALIBRATION The calibration of the MYTHIC 18 should be carried out only if the QC carried out on a blood control used under the recommended conditions is out of the limits to a significant degree see section 6 The calibration blood must be used before its expiry date be mixed and stored in accordance with the instructions of use recommended by the manufacturer
3. lt lt d TOOLS ip EN To print send delete or save in an USB key results press 94 11 04 s10 10 04AM DATE allows to accede to the results date list SELECTION CALL PAGES 36 It is possible to print send delete or save in a USB sea 8538 8538 All results Press NB PRGES 36 for printing Selected results Select the first and the last results SEQ sFROM RESULT PRINT Then press ID PRLRDO PID FR567 95 11 84 510 00420 18 15AM This prompt appears to confirm the storage the USB key PREVIOUS SCREEN 2001 2001 2802 2802 2802 2802 2802 2803 2803 2803 2803 2803 If you press LES the selected results will be deleted from the internal memory and stored in the USB key This prompt allows to following the storage PROCESSING PLERSE WRIT SRUING RESULT 0090 0100 MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 47 84 5 SAMPLE ANALYSIS REF M18C UM EN 012 SELECTION NB PRGES 37 FROM TOOLS To print send delete or save results per day press EE It is possible to print send delete or save All results of the same month Press FROM Between two days of the same month press The prin
4. sip 88981 _______ STANDARD 5 7 RESULTS LE OOOO coco OOOO QI DOLU c SLIC 2 2 09 gt coo 25 2 The results of the analysis are sent before the cycle is finished to be checked at the same time as the printer starts NOTA It is not necessary to wait for the end of the result printing to TOOLS MENU 30710 18 38 TYPE STANDARD BC 11 2 launch a new analysis MONS 132 H M GRAZ 56 5 The results are sent to the selected unit see section 3 RBC 6 18 Hee 151 The information located on the right of each parameter corresponds to HEH B the indicators for out of range limits and for the rejections see section 3 MEER The curves of distribution of each cellular population are located on the E en p right screen Under the results zone FLAGS is reserved for analytical alarms At the bottom of the screen there are the three inlet fields for the identification of the following sample See section 5 6 2 TOOLS Press to reprint or to resend the result FLAGS FLIFL2FLS FRIFR2 STARTUP FAILED GC FAILED SID 00001 TYPE STANDARD Page 44 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 5 SAMPLE ANALYSIS 5 82 11 18 20 TYPE STANDARD i To print th
5. Field strengths 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 strength 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 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 strengths should be less than 3V m The symbol on the product indicates that this product be treated as household waste Instead it shall be handed over the applicable collection point for the recycling of electrical and electronic equipment By ensuring this product is disposed of correctly you will help prevent potential negative consequences for the environment and human health which could otherwise be caused by inappropriate waste handling of this product For more detailed information about recycling of this product please contact your local city office or your distributor of this product Page 4 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 Orph e KONFORMITATSERKLARUNG
6. ID AND OR PID MANDATORY CHECK SETUP SID INTERN COUNT ERROR INTERN RESULT AREA IS LOCKED NUMBER MAX OF FILES REACHED PLEASE PRINTER DRIVER UPDATE FAILED THE CHOSEN DRIVER IS NOT COMPATIBLE WITH THE MYTHIC 22 SYSTEM RINSE NOT DONE RS232 INTERNAL ERROR Wait before performing a cycle Change the valve representative Perform an initialization or a control cycle Change the valve Replace the container and perform a prime Diluent Switch on the printer or invalidate the printings Re start the Mythic Re start the Mythic Select other lot Perform an initialization or a control cycle Perform an initialization or a control cycle Re start the Mythic Re start the Mythic Perform a pistons greasing Perform a control cycle Call an Orph e representative Switch on the printer or invalidate the printings Modify the value Perform a control cycle Close the door in case of emergency stop run a control cycle Run Startup Cycle If the problem still occurs call an Orph e May occurred by leak of reagent check tubing in the fluidics Re start the Mythic Wait for the system to reach its temperature Enter an ID and or PID and SID Re start the Mythic Wait before performing a cycle If persisting re start the Mythic The files format are not available for the Mythic Replace the bottle and perform a prime Lysis Pe
7. EE 80 STRRT UP SHUT DOWN CRLIBRRTION QUALITY CONTROL RESULTS SET UP SERVICE OPERATOR LOG OUT RERGENTS LOGS RUN SAMPLE CRLIBRRTION To reach the screen Calibration press the key emon from the main menu This menu sends the following information o Lot number of the last used calibrator PREVIOUS 001 5 MEN 2 SCREEN dm LOT o The expiry date of the current lot LOT CS224 EXPIRY 06 01 04 o Thelast date of calibration Sio EN o The operator name BY BOB EE target values WBC 9 5 1 current coefficients of calibration RBC 4 25 1 888 m HGB 16 5 1 028 ES uc PRINT Press to print send or save in a USB key PLT 375 1 008 all these information SEND CHRNGE SAVE RESULT EXIT RESULT CHRNGE To enter new values to modify the values press To calibrate press NOTA If the M letter appears on the right of the date of calibration that means that the last calibration was done by modification of the calibration factor see section 3 4 5 MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 55 84 7 CALIBRATION REF M18C UM EN 012 Model of print out calibration report CALIBRATION IN PROGRESS SER SOF PRINTED ON 19 06 2004 15 50 00 BV BILL COEFFICIENTS 1 606 1 606 1 000 1 808 1 808 LOT cs224 CRERTED ON 18 12 2003 BV BILL EXPIRY 0670
8. 3 INSTRUMENT SET UP REF M18C UM EN 012 If this window appears it means that several results in memory have not been SOME RESULTS HAVE TO BE sent before the MYTHIC 18 was switched off SENT DO YOU WANT TO SEND Press YES to send them immediately or press LATER to wait for another time NO if you do not want to send them No USB key is available connect an USB key then press YES or see section 3 4 7 EE to change the archive mode NOT SRUED ONTO THE EXTERNAL STORAGE DEVICE 00 YOU WANT THESE FILES TO BE MOVED ONTO IT 3 2 SYSTEM STATUS Press on the date and hour SHUT DOUN window CRLIBRATION QUALITY CONTROL RESULTS SET UP SERUICE OPERATOR LOG OUT RERGENTS LOGS RUN SAMPLE to have access to the system status PREUIDUS e SCREEN TOOLS MENU Different system status information is displayed 10 OPERATOR ACCESS SETUP VERSION SOFT VERSION To return to the MAIN MENU press LE Page 24 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 3 INSTRUMENT SET UP 3 3 SET UP From the MAIN MENU press on This menu is available for all users DATE amp TIME Nm SCREEN The DATE amp TIME window enables to modify the time and the date To select the language of the Mythic menu choose the
9. SET UP SERUICE SHUT DOUN From the main menu press LU M MYTHIC 18 automatically perform a shut down cycle the hydraulic circuits are rinsed and then cleaned with the cleaning solution At the end of the cycle MYTHIC 18 automatically stop Shut Down can be automatically performed after a setting time see section 3 4 6 OPERATOR LOG OUT NOTA After a shut down it is impossible to perform an analytical cycle without launching a start up cycle See section 5 2 RERGENTS LOGS RUN SAMPLE A MYTHIC 18 must stay at rest with cleaning solution during three hours every 24 hours MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 49 84 6 QUALITY CONTROL REF M18C UM EN 012 6 QUALITY CONTROL 6 1 INTRODUCTION Quality control allows checking the stability of the MYTHIC 18 analytical performances when operating manufacturer instructions for use It must be well mixed before use The control blood must be used before its expiry date and stored according to the In case of no local regulation it is recommended to run a control blood at the beginning of each working day before running sample In case of exceeding the tolerances indicated on the blood control result sheet it is recommended to perform a calibration see section 7 6 2 QC MYTHIC 18 stores in memory up to 100 results per lot for 6 different lots Results of each lot
10. e Press ESC to leave the menu without modification Any modification lot number date or target values involves the deletion of all the associated results always in memory PREVIOUS SCREEN LOT ABC123 ZER456 203 458JFD CBR488 15 789 RBC128 ZXR456 BHRFD CJJT288 C2C3789 KKDFES ET 55 214 Ed EH y Press m to load from a USB key all the information about a new lot of calibrator Press sl you are sure to load the right file DO YOU CONFIRM TO LORD THE FILE 123 gt MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 57 84 8 REF M8C UM EN 012 8 TECHNOLOGY 8 1 DETECTION PRINCIPLE 8 1 1 WBC RBC PLT Counting The counting of the cellular elements in a blood sample is done with the impedancemetry technique This technique is based on the modification of the impedance of a calibrated aperture soaking in an electrolyte and going through a constant course delivered by two electrodes located on both sides of the aperture A vacuum applied on a side of the aperture allows the cells passage They oppose their physical volume to the course passage A voltage impulse is registered at the electrodes terminal The height of this impulse is proportional to the cell volume VACUUM Aperture 7 Electrode Detection area Proportional heigh
11. 2 Needle or o ring replacement 9 4 3 ene 9 4 4 Baths o ring replacement cce ome e EGRE HER RE RR UHR IH ee tiun 9 4 5 Aperture block replacement Js 9 5 TROUBLESHOOTING ttt ta totae te Ga tap aot da pasta da bcd een able da breton d Gea debct bte da bereit tt 9 5 ANA problems Re ete ME Me Mc EE UE 9 5 2 UR 9 6 TROUBLESHOOTING MESSAGE aee ni nana REA Rp 9 7 LOGS ERROR fM 9 8 T Page 8 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 1 INSTALLATION 1 INSTALLATION 1 1 UNPACKING 1 1 1 Introduction The MYTHIC 18 is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories by an authorized people Only human blood or artificial control blood should be run Only the reagents mentioned in this manual are permitted to use The optimum performances can be only achieved if the cleaning and maintenance procedures are carefully followed If the MYTHIC 18 has been stored at a temperature less than 10 C it must stay at room temperature during 24 hours before switching it on 1 1 2 Unpack ing Procedure Before unpacking the instrument we recommend to check the box of the instrument and notify any
12. 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 9 SERVICE Wear rubber gloves and wash hands with a disinfectant after completion of work Wait for the information window and then Open the door on the right side see section 1 1 3 Put a small nut of grease on a finger Put a thin film of grease around each piston Turn the two big pistons waste pistons with the help of the key supplied in the installation kit Continue to put a thin film of grease around each piston The other pistons can be turned with fingers PREVIOUS SCREEN To have access to the hydraulic cycle press from the MAIN MENU then press MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 69 84 9 SERVICE REF M8C UM EN 012 To drain the counting baths and the waste syringes press To fill the counting baths with 2 ml of diluent press To perform a cleaning of the aperture block with the cleaner press To perform back flush in the aperture blocks press 9 3 MECHANICS PREVIOUS SCREEN To have access to this cycle press Nu NN from the MAIN MENU then press ce venues See below NR Lol Jm Performs a complete test of the needle A a complete test of the rocker _____ CHECK SYRINGE performs a complete test of the syringe ____________ to check the different sensors euer on or off t
13. CONTINUE 6 3 REPEATABILITY START UP SHUT DOUN d a ae REAGENTS LOGS SERVICE To run repeatability press first RE MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 53 84 6 QUALITY CONTROL REF M18C UM EN 012 PREVIOUS N SCREEN MOTOR INIT HYDRAULICS MECHANICS REPEATABILITY LOG ERRORS TECHNICIAN 11 2 6 18 1145 21 501 aj EN 12 71 5 25 HORRERT 15 11 21 6 12 2 2 3307 mr 5 85 EN 11 e as e c c Al co cn zen fn lili l cof co gt gt gt 5 gt 0 co n in en Pol in ro w w w raf wf f w ree pal af mal ma ms Oy col pox N c memp Pan od RIDE Gh bal Eb oa Ap A sO ES ET w w e v N a p in al 020 wee PLT i 19 91 5 97 15 9 48 9 323 8 ERN 02 2 5 151 8 21 a4 A 2 21 2 1 1 6 0 7 2 40 PREVIOUS Tani MENII 020 wee HGE TR NET fam 19 91 5 97 15 0 48 9 323 8 ERN 5 515 151 2 2 a4 A 2 1 2 1 1 6 0 7 2 40
14. DECLARATION DE CONFORMITE DECLARATION OF CONFORMITY DICHIARAZIONE DI CONFORMITA Name und Adresse der Firma Orph e S A Nom et adresse de l entreprise 19 Chemin du Champ des Filles Nome e indirizzo della ditta Name and address of the firm 1228 Plan Les Ouates Wir erkl ren in alleiniger Verantwortung dass Nous d clarons sous notre propre responsabilit que Dichiariamo sotto nostra responsabilit che We declare under our sole responsibility that das Medizinprodukt f r die In vitro Diagnostik le dispositif m dical de diagnostic in vitro Mythic 18 il dispositivo medico diagnostico in vitro the in vitro diagnostic medical device mit folgender Klassifizierung nach der Richtlinie ber In vitro Diagnostika 98 79 EG avec la classification selon la directive relative aux dispositifs m dicaux de diagnostic in vitro 98 79 CE con la classificazione secondo la direttiva relativa ai dispositivi medico diagnostici in vitro 98 79 CE classified as follows according to the directive on in vitro diagnostic medical devices 98 79 EC L Produkt der Liste A Anhang II Dispositif de la liste A annexe II Dispositivo dell elenco A allegato II Device of List A Annex II L Produkt der Liste B Anhang II Dispositif de la liste B annexe II Dispositivo dell elenco B allegato II Device of List B Annex II Produkt zur Eigenanwendung das nicht in Anhang II genannt ist Dispositif destin l autodiagnostic non list dans l anne
15. Reserved MYTHIC 18 REF M18C UM EN 012 4 SPECIFICATIONS 4 SPECIFICATIONS 4 1 ANALYTICAL SPECIFICATIONS Throughput 60 samples hour approx Sample Volume 9 8 ul approx Measurement Principle WBC RBC PLT Impedancemetry Hemoglobin Spectrophotometry at 555 nm Hematocrit Volume integration Linearity Linearity is measured with linearity sample performed four times for each level PARAMETERS RANGE LIMITS the larger WBC 10 mm O to 100 0 4 or 4 RBC 105 mm 0 1 to 8 0 07 or 3 HGB g dL 0 5 to 24 0 3 or 2 HCT 5 to 70 2 3 PLT 105 mm 5 to 2 000 5 5 Reportable range Within the reportable range the results are flagged with a D to indicate that it is necessary to re dilute and re run the sample PARAMETERS REPORTABLE RANGE WBC 10 mm 100 to 150 RBC 105 mm 8 to 15 HCT 70 to 80 PLT 103 3 2000 to 4 000 Repeatability Calculated with 20 runs of a fresh whole blood sample performed on a commercial MYTHIC 18 PARAMETERS CV RANGE WBC lt 2 5 gt to 6 0x103 mm LYM 5 15 MON 10 to 5 GRA 3 50 RBC lt 2 gt to 4 0x105 mm HGB lt 15 gt to 12 0 g dL HCT 2 gt to 35 0 lt 1 to 85 fL RDW 3 to 12 PLT 5 gt to 200x10 mm PMV 3 gt to 7 fL Cal
16. SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 4 SPECIFICATIONS 4 2 PHYSICAL SPECIFICATIONS General Ambient temperature from 18 32 C Relative Humidity 80 maximum at 32 C Storage temperature 10 to 50 C temperature during 24 hours before switching it on If the MYTHIC 18 has been stored at a temperature less than 10 C it must stay at room INSTRUMENT Dimensions Height 350 mm approx Width 250 mm approx Depth 340 mm approx Weight 9kg approx Power supply Input 24V DC Electric consumption In cycle 30 VA 30 10 Stand By 20 VA 30 10 Maximum 50 30 10 Display Monochrome LCD 240 320 Mode portrait Retro lighted Barcode option Barcode reader C39 Barcode 2 interleaved 5 Memory capacity 1000 Files Demographics results and histograms QC 6 levels 100 Files per level Connection RS 232C Ethernet TCP IP MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 35 84 4 SPECIFICATIONS REF M8C UM EN 012 Reagent Consumption ml Software Version 0 5 CYCLES DILUENT LYSE CLEANER Run Sample 12 80 0 34 0 42 Rinse 6 00 Back flush 6 00 0 20 Control 10 00 0 84 All 28 00 4 00 9 00 Lyse 12 00 3 00 Reagent Prime Diluent 30 00 Cleaner 8 60 Cleaning 6 00 2 10 Bleach 6 00 Start Up 32 80 0 34 0 42 Shut Dow
17. USB THUMB DRIVE FORMAT Choose for a FIFO first in first out mode or real time to store the results in the resident memory or in a USB key REAL TIME RUNS SAVE enables to save the results in the USB key at the end of each measurement cycle Press _vau save the modification Press _ use DRIVE Former to format USB key system will format the USB Key and build specific directories for Mythic management This prompt appears if none USB key is available Press yes if you agree to format the USB key It is mandatory to format the USB key on the Mythic before to use it ABO 0 FORMAT DRIUE DO the information includes in the USB key will be erased MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 31 84 3 INSTRUMENT SET UP REF M18C UM EN 012 3 4 8 Version release Em teuer TOOLS ES E UERSION RELERSE Press _ to load new software version from USB key Choose the right version then Press yes only if you are sure to load new version software 070 002 The current software version will be erased definitively This prompt appears to confirm the version loading ti THE This prompt appears when the release of the software is failed H THE MYTHIC Choose another version or call your Orph e s representative Page 32 84 Copyright9 Orph e SA All Rights
18. analyses carried out on one calibrator during the same day remain with the screen and are used in calculations if they are selected Page 56 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 7 CALIBRATION 7 1 2 Calibration Before to start the calibration unselect the results which you do not wish to use for the calculation of the calibration see below section 7 1 1 CRLIBRRTION TOOLS The key E mmn or allows CALIBRATION 7 7 e To calibrate with the selected results RBC HCT 2 delete the results Press Ss PRINT e To print the results Press ED see below the print P P CAL IERATION report To calibrate one or more parameters COEF 1 0 1 8 1 6 1 8 1 0 Select the parameter Ei 5 016 001 9 8 amp G CALIBRATION 2 21 6 010 601 S G 0 0 e Press the key 7 2 TARGET VALUE MODIFICATIONS PREVIOUS modify information relative to a batch to create a new batch please follow the following steps CHRNGE From Calibration Menu press e Select the lot number LOT 25224 modify the lot number press Az e Select the field to be modified e Enter your new value with the numerical keyboard or with the alphabetical keyboard LOT ExPIRv ee e1 es CREATED ON 22 09 G8 BV BILL Press to validate your modifications
19. can be viewed in tables and Levey Jennings graph PREVIOUS 22709 QUALITY CONTROL Press to have access to the quality control START UP SHUT DOWN menu CRLIBRRTION QUALITY CONTROL RESULTS SET UP SERUICE OPERATOR LOG OUT RERGENTS LOGS RUN SAMPLE PREVIOUS Sem 2 SCREEN LOTS v 01640 1762 L MBxaissi N Quality control display presents the identification of the lots The last active lot is labeled with a dark dot on the left lot To choose another lot press on the wished lot mpxai7e2 L C CHANGE The key allows the modification of the identification and the target values RESULT CHANGE The key allows To view the result table To perform quality control analysis RESTORE The key allows restoring the data from a USB key results and targets see section 6 2 4 RESULT RESTORE TOOLS To print or send the targets results and graphics press KH 50 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 6 QUALITY CONTROL PREVIOUS 01640 MEXG1581N 1762 PRINT TRRGETS PRINT RESULTS PRINT GRRPHICS PREVIOUS SCREEN BY BOB TARGETS LINITS uec Lm row PLT LOT EXPIRV CRERTED ON 15 06 04 LEVEL LON TRRGETS LIMITS nonz Gne
20. information listed below Guidance and manufacturer s declaration Electromagnetic immunit The MYTHIC 18 is intended for use in the electromagnetic environment specified below The customer the user of the MY THIC 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 1 2 P 80MHz to 800MHz IEC 61000 4 3 80Mhz to 2 5Ghz d 2 34P 800MHz to 2 56Hz 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 strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol t NOTE 1 At 80Mhz and 800 2 the higher frequency range applies NOTE 2 Theses guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people
21. logs of the number of pages indicated on the screen T T1 T1 7 To print the logs of one or more days select DAY then enter the EBEN XIXIXIXIXI BM MN day reference number ES m 4 En 1 _ allows to save the log file in an USB key DATE 02 18 2004 5 10 ARCHIVE STRRT UP SHUT DOWN CALIBRATION QUALITY CONTROL RESULTS UP SERVICE OPERRTOR LOG OUT RERGENTS LoGS RUN SAMPLE Page 46 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 MYTHIC 18 can save more than the last 1000 patients with results alarms distribution curves RESULTS Press to enter the archive display REF M18C UM EN 012 5 SAMPLE ANALYSIS 5 10 1 Results ESS The Archive display allows viewing the results of the analysis The first column presents the name of the different parameters the first line the result number The results of the patients are presented in column At the bottom of the display under the table the ID PID SID SEQ number date and time of the selected patient dark background are presented for each result selected The button 551 22 located under the table allows changing pages To find a result in the list select the SEQ number wanted press To view an entire result select the SEQ number wanted press VIEW
22. ncu cuc Pou Tag the lot number to select then press the appropriate button allows to save the targets results and graphics in the USB key In this display the user can enter the o Lotnumber o Expiry date o Target values and tolerances o Level Press _ to delete the modifications you made Press mum to validate your modifications or the loading Press CE to change the Lot number To print the targets and limits come back to the previous display Press Lom to load the target and tolerances values the lot number and expiry date from a USB key NOTA All the results in memory linked with the control lot number will be cleared as soon as the validation is confirmed PREVIOUS SCREEN LOT ABC123 Press m to load from a USB key all the information about a new lot of calibrator Press file if you are sure to load the choice MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 51 84 6 QUALITY CONTROL REF M18C UM EN 012 6 2 2 Run control blood PREVIOUS SCREEN LOTS MBXG164 H MBKG1762 L mexaissin MBxai762 L CHANGE RESULT RESTORE SEL PREC 11 2 25 pes 72 4 E i 45 2 33o 14 8 48 5 315 x 49 0 24 8145 81 3581 0 16 6 72 2 2 2 28 741 EN 1 56 158 43 2 3301 __ ue
23. of these alarms appear on the right of the result In presence of one or more alarms it is recommended to check the result by a conventional measure or on blood smear NOTA Most of these alarms can be modified by the user see section 3 8 5 1 General Flags The following alarms are common for all parameters Counting or measure rejection Can appear with WBC RBC PLT and HGB see section 8 5 3 HGB XXXD Higher than linearity limits but lower than the reportable limits WBC RBC PLT HGB D Higher than the reportable limits WBC RBC PLT HGB h results higher than normal value b results lower than normal value H results higher than panic value B results lower than panic value MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 61 84 8 REF M8C UM EN 012 8 5 2 Leukocytes Flags L1 CL1 to CL1 2 Platelet aggregate or erythroblast L2 CL2 to CL2 2 Presence of Myelocytes lymphoblast or basophiles L3 CL2 to CL2 3 Presence of eosinophils myelocytes L4 CL4 Granulocyte volume too low L5 CL5 to the end Presence of large size cells 8 5 3 Erythrocyte and HGB Flags CR1 CR2 a 21 CR1 Abnormal quantity of microcytes at the left side R2 CR2 Abnormal quantity of macrocytes at the right side HGB means bad measure of the HGB blank 8 5 4 Platelet Flags P1 O to CP1 Presence of abno
24. right one in the LRNGURGE ENGLISH gt Language combo box PRINTER LRNGURGE ISH PRINTER Select the printer or no printing PRPER SIZE fis LETTER gt Select the paper size depending on the number of results per page PRPER SIZE 11 LETTER babes START DAY SID Two SID are available Start day SID enables to select the first SID for each new day o mon CURRENT 510 If you want to select a new SID number Esc PRINTER 3 UPDATE See section 3 4 RDURNCED MUR Biologist reserved for complete settings Once modifications are done press either po to valid or lt to exit keeping the previous setting TOOLS to print save or load from an USB key all the set up To load new printer drivers plug the USB key then press on LPRINTER 8 UPDATE in the previous screen Select the printer and its connection mode LOAD PRINTER PORT Then press VES Press then the driver is loaded in the MYTHIC 22 This prompt appears if the release is failed Check the USB connection or change the USB key or call your Orph e s representative MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 25 84 3 INSTRUMENT SET UP REF M18C UM EN 012 3 4 ADVANCED SET UP COMMUNICATION ANALYSIS OPTIONS LAB PARAMETERS CALIBRATION FACTORS OTHER SETTINGS STORAGE OPTIONS UER
25. solution at 12 in chloride or 3 6 diluted 4 times with distilled water if sodium hypochlorite is concentrated at 487 in chloride or three times with 367 Page 66 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 9 SERVICE MENU Return to the main menu by resino Then press Press ae HEN to start the cycle drain the counting chamber MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 67 84 9 SERVICE REF M8C UM EN 012 Wear rubber gloves and wash hands with a disinfectant after completion of work Wait for the information window and then Open the door on the right side see section 1 1 3 Put 2 ml of sodium hypochlorite solution 12 or 3 6 in each counting chamber Press the button in the window located in the screen center MYTHIC 18 perform a maintenance cycle of the apertures follow with a standby mode during 2 min After 2 min MYTHIC 18 rinses all of the elements Perform a blank cycle before to run any analytic cycle from the MAIN MENU then press Operators must be trained and to know that due to moving parts there is a risk to pinch their fingers between pistons and the syringe body M PREVIOUS SCREEN Press _werrcarton pos to put the piston of the syringe module in the greasing position Page 68
26. the container add 100ml of bleach at 36 Chl mix the container wait one hour before empty it A Page 12 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 Only use this procedure if there is no specific local legislation for the treatment of the waste REF M18C UM EN 012 1 INSTALLATION 1 5 2 Priming When first starting the MYTHIC 18 it is necessary to perform a complete prime of the fluidic circuit A Before starting be sure that all the reagent and waste tubes are properly connected Priming procedure Switch on Connect the power supply block TION IN EM UPDATE Press the ON OFF button EXCEED 3 The cycle LED turns red No cycle can be performed before it turns green The information window could stay up to 3 mn to enable the update of all files The operator s identification display appears LOGIN Enter the user s identification the password see section 3 1 and press password OK a z x x to validate AUTONOMY run 12 AUTONOMY run indicates the number of samples runs you can perform calculated with the smaller quantity of reagents MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 13 84 1 INSTALLATION REF M18C UM EN 012 PREVIOL US SaaS 3 System priming The main menu is displayed Press on If this window appears it means that sever
27. the flags level see section 3 4 4 3 i 1 to adjust the corrections factors see section 3 4 4 4 NOTA No correction factors with type STANDARD RENAME TYPES To enter a new blood type press NOTA The name of the first type STANDARD cannot be change then BLOOD TYPE Press to print the blood type set up PRINT ALL SS allow to print all the blood type set up about 20 pages are inted EXIT PRINT SELECTED nore only the blood type in the combo box is printed MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 27 84 3 INSTRUMENT SET UP REF M18C UM EN 012 3 4 4 1 Limits TYPE STANDARD D Z mu o M ol Sll c m nm rol ro cra nie elo e T co op eile He o c NN ol c c j E all leo bod Red air an cia 232 UG rc ro ceo e gt aie E E 4 70 a m arie gum 7 x bad wo BI This display enables to enter normal and panic limits for every 18 parameters given by the MYTHIC 18 see sect
28. tubing 0 8x2 4mm 1 3 3 1 6 3 2 2x4mm 3x6mm Part Number Designation 005 1001 90 01 Tubing 1 820 180mm 005 1001 90 02 2 250mm 005 1001 90 03 Tubing 3 135 20mm 005 1001 90 04 Tubing 4 175 15mm 005 1001 90 05 Tubing 5 210mm 005 1001 90 06 Tubing 6 170mm 005 1001 90 07 Tubing 7 220mm 005 1001 90 08 8 80mm 005 1001 90 09 Tubing 9 425mm 005 1001 90 10 Tubing 10 370mm 8mm 005 1001 90 11 Tubing 11 90mm 005 1001 90 12 Tubing 12 60mm 005 1001 90 13 Tubing 13 250mm 005 1001 90 14 Tubing 14 250mm 005 1001 90 15 Tubing 15 1000mm 005 1001 90 16 Tubing 16 130mm 005 1001 90 17 Tubing 17 80mm 005 1001 90 18 Tubing 18 80mm 005 1001 90 19 Tubing 19 80mm 005 1001 90 20 Tubing 20 130mm 005 1001 90 21 Tubing 21 600mm 005 1001 90 22 22 200mm 005 1001 90 23 23 DILUENT 1500mm 005 1001 90 24 Tubing 24 WASTE 1500mm MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 83 84 9 SERVICE REF M8C UM EN 012 3ONIPAS YAS 315 YAS 315 F r INIuAS 3547 PRESSURE SENSOR 22 LYSE CLEANER Page 84 84 Copyright Orph e SA All Rights Reserved MYTHIC 18
29. 10 10 L 150 to 400 150 to 400 150 to 400 150 to 400 150 to 400 150 to 400 Page 28 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 3 INSTRUMENT SET UP 3 4 4 2 Thresholds STANDARD WBC cL1 ge1 cL1 2 M2 cL2 42 1 2 2 18 2 CLS PLT E CP1 2 CP3 2 WBC mi cL1 1 11 2 M2 cL2 42 1 2 2 e18 cr 2 8 CLS FLAGS WBC 8 8 LYNZ 6 6 0 0 GRA 0 0 ESC TEST INIT DEFAUL 1 va 3 4 4 3 Alarms TYPE STANDARD t m 55555 19 0 22255 rcs 15 0 05955 Fis 55 5 22220 rcs 22225 Fri 18 8 05555 Fre 5555 Fei 18 8 22225 re 15 8 95553 rea 05555 DEFAULT _vaio 18 The threshold display enables to modify the detection thresholds located on the WBC RBC PLT curves Threshold modifications can affect the quality of the results or can affect the alarm detection area We recommend modifying these values only after an Orph e s training Once modifications are done press _vau to validate or ESE to exit without any modification INIT DEF Press to return to the manufacturer parameter setting This screen allows displaying the WBC thresholds position after a run After modification press to allow the recalculation and chec
30. 172004 RBC HCT PLT TARGETS 4 25 5146 91 37 LIMITS 5 8 24 5 2 1 2 aa COEF ol 1 8 MEAN ola STOU 0 00 CUR ao 8 04 81 5 8 ol olels i 7 1 RESULTS 7 1 1 Calibration blood analysis This screen allows carrying out analysis on calibration blood to perform the MYTHIC 18 calibration PREVIOUS 001 5 MEN SCREEN LI EN o T T T FT Present the calibration tube under the sampling needle and press the trigger behind the needle The cycle LED m located at the top of the needle flickers alternatively of red with green when it becomes red the tube can be removed The results are progressively sent on line in the table Repeat the operation as many times as desired maximum 10 runs Statistical calculations are carried out automatically with each run CRLIBRRTION CALIB LOT CS224 Wee BEC Hop PLI The window toT 0324 located between the results and the statistical calculation reminds the lot number of the calibrator The column 5 amp allows to validate or to unselect a result 0 1 9 9 08 8 6 01 6 01 6 0 1 6 81 CRLIBRRTION To calibrate press or Before to run the calibrator check and clean the opening of the cover dedicated to the down of the needle to avoid any fall of dry blood particles inside the calibrator tube NOTA The results of the
31. 4 0 MCHC 32 8 g dl 31 0 7 35 5 RDW 12 1 2 18 80 7 16 8 PLT 350 18 27p1 158 408 MPU 8 6 pm 8 7 0 7 11 0 PCT 8 325 A 8 208 8 5808 12 2 18 0 18 8 FLRGS FL1FL2 Comments MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 45 84 5 SAMPLE ANALYSIS REF M18C UM EN 012 5 9 LOGS From the main menu press s to reach the logs display MYTHIC 18 manages a simplified log allowing to save and display all the events done for the following actions Login with the Biologist code TEC Login with the service Technician code STC Login with the Super service Technician code An intervention or maintenance has been performed 50 Start Up cycle has been performed SUF Start Up cycle has failed SDN Shut down cycle has been performed DIL Diluent replacement LYS Lysis replacement Cleaner replacement ACN Auto cleaning cycle Bleach cycle CAL Calibration Quality control Results deleted in Archive PREVIOUS m CEN Each column is identified by a number recall at the right bottom of SELECTION the screen In the bottom of the screen is displayed the date NB PRGES 8 DAY FROM DATE 8271972994 and under it the number of analysis NUM run PRINT Al DATE 6271072004 during this day TOOLS To print the log report press EH Select to print the
32. 5 85 uu 48 5 3151 EN 11 21 6 00 FERE 45 6 EN 5 5 14 5 45 0 5521 4 2 Lot MExe1648 H Lu 000 wee eee HOT PLT es ANT 2 91 6 00 6 8 ol 8 EH 0 2 s ee e a 0 06f 2 9 5 916 017 6 0 1 aal a PREVIOUS RESULT PRINT SEND DEL NOT SELECT Tan c MENIT finn wee HGB HCT PLI rici mum o e 0 00 0 0 a a al Ex 0 2 s ee e a 2 01 al 8 EPA 2 02 2 aol a 52 84 RESULT to run the control blood Before to run the control check and clean the opening of the cover enabling the descent of the needle to avoid any fall of dry blood particles inside the control tube Copyright Orph e SA All Rights Reserved To run quality control analysis o Press Results o Present the control blood under the sampling needle o Press the start cycle trigger The cycle LED ba located at the top of the needle flickers alternatively of red with green when it becomes red the tube can be removed Repeat this operation as long as needed The results are displayed in line run after run The statistic calculations are shown at the bottom of the display and are automatically done after each run The cursor the other parameters allows displaying results for The window allows access to the results in memory for another blood control lot The column allow
33. 64 NIT PRINTER 61706 64 15 865 0 PRINTER SE 82796 12 33 066 RINTER IS BU 93796 28 51 867 FRINTER NO P 04206 04 09 068 JO PRINTER SE 85796 12 27 069 RINTER IS 6706 20 45 878 JO PRINTER RE 87786 84 83 871 FRINTER ERROR 98796 12 21 872 NTERN RESUL This screen allows visualizing the date and timing when an error has occurred as well as the code and the origin of this error To see the origin of the error press on the figure located on the left of the date the complete error appears at the bottom To print it press 1 83786 28 39 873 IRCKUP SYSTE 421127026 84 57 874 FACKUP SYSTE BACKUP SYSTEM ERROR tone W meni SELECTION NB PAGES 5 ERR FROM TO Select to print the errors of the number of pages indicated on the Screen To print or save in an USB key the error of one or more days select ERR FROM 256 then enter the error reference number BACKUP SYSTEM ERROR Page 82 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 9 SERVICE 9 8 HYDRAULIC DIAGRAM The length and inner diameters of the tubing shown on the diagram below the tubing table must be strictly respected when replaced otherwise there is a significant risk in the quality of results given tubing tubing tubing tubing
34. D 6 NOT EXCEED Means an ERROR WARNING You have to INFORMATION window occurred it is mandatory confirm or not the action to do the action describe describe in the window in the window or in the table section 9 6 8 8 2 Menu tree Page 64 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 8 TECHNOLOGY WSN NN NEN MSSR 8 Launch Mechanical action View Results VIEW DATE View full screen View by date and by device Internal history memory Mass storage fai quem d i OPTIONS 22 FACTORS SETTINGS OPTIONS RELEASE RSS 1 i M om ALARMS ______ SENS NI NES D CHECK ROCKER CHECK SENSORS HGB LED OFF NS SAW poem WS NSS KKKK meajo agen E Ec Launch new menu L Launch Mechanical action Entry menus View Results MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 65 84 9 SERVICE REF M8C UM EN 012 9 SERVICE The quality of the results and the reliability of the MYTHIC 18 are directly linked to the strict respect of the maintenance hereafter described To perform the maintenance and the repair described in this section it is mandatory to have received adequate training to wear rubber gloves and wash hands with a disinfectant after c
35. ENTS LOGS RUN SAMPLE Reagent replacement Analysis performing section 5 5 section 5 3 Calibration section 7 Quality Control section 6 Patient Archive section 5 10 Mythic Parameters section 3 Maintenance and Service Menu Log In and Log Out section 3 1 Mythic Events Logs section 5 9 MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 19 84 2 GENERAL OVERVIEW REF M18C UM EN 012 2 3 2 Dilution hydraulic part the fluidic 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 Syringe module Counting module Page 20 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 2 GENERAL OVERVIEW 2 3 3 Mono electronic board mut ES JL UB 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 Disp
36. IN ent displayed PASSWORD In the window 081 BILL the last operator s identification 2 OK 5 Either the identification is yours press PASSWORD L land enter your AUTONOMY CBC run TTE Arce AUTONOMY DIF run 12 password or the identification is not press to enter your login The window enables to change the language Press 2 to validate it AUTONOMY run indicates the number of samples runs you can perform calculated with the smaller quantity of reagents Orph e LOGIN PASSWORD Enter your identification name with the alphabetic keyboard Place the cursor in the Password window Enter your password for identification For the first login MYTHIC 18 propose 3 access levels o User No password Biologist Password by default 1 2 3 o Service people Biologist Password can be modified in section 3 4 6 JENNI 3 1 2 In process PREVIOUS EX SCREEN TOOLS MENU STRRT UP SHUT DOUN CALIBRATION QUALITY CONTROL RESULTS SET UP SERVICE OPERRTOR LOG OUT RERGENTS LOGS RUN SRHPLE MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 23 84 MENU To change operator during the process press EZR to return to the OPERRTOR LOG QUT main menu and then press on To change identification proceed as described above section 3 1 1
37. NG MESSAGE This section allows knowing what to do when a troubleshooting message appears on the screen In any case if a problem is not solved call Orph e s representative MESSAGE ACTION BACKUP FOLDER NOT FOUND BACKUP CALIBRATION HISTORY IS FULL BACKUP FAIL TO SAVE RESULT ONTO THE EXTERNAL STORAGE DEVICE THE INTERNAL Re start the Mythic Re start the Mythic Delete the calibration results Please connect USB thumb drive to the analyzer MEMORY IS USED BACKUP MEMORY IS ALMOST FULL PLEASE DELETE RESULTS COM SIZE ERROR CYCLE STOPPED BY USER Re start the Mythic Memory full next result will not be saved You have to delete results Delete results Delete the stored results Delete the results of the ongoing lot Delete the repeatability results hardware failure on memory Re start the Mythic Perform a rinse cycle Replace the bottle and perform a prime Cleaner Rebuild cycles with good options Communication error retry Try to send the file again If the problem still occurs call an Orph e representative Perform a control cycle Emergency stop please perform a control cycle MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 79 84 9 SERVICE REF M18C UM EN 012 MESSAGE ACTION CYCLE BUSY CYCLE EMERGENCY STOP CYCLE HGB CHANNEL SATURATION PLEASE RUN STARTUP
38. PECIFICATIONS nn nn n t ande nda Ran 4 3 REAGENTS SPECIFICATIONS dp Ra ABORTO ERROR DRE 4 3 DIlUento os E Et b vv ot E PLE 4 32 LYSIS A 323 Cleaning 4 4 ANALYTICAL LIMITATIONS s ss 4 3 Recommendations ede el e oe a dil ehe it rebat Oni biete 42 5 SAMPLE ANALYSIS 5 T VERTFICATIONS BEFORE STAR TING octies iret oet lee o b 40 52 S 40 5 3 REAGENT REPLACEMENT eet RE bt o Eb teo e eb E rt ede o n Eco E Ec e tete 41 BASS TART UP RINSING at ro Ma Ma vw ab RC vC an b CO EM va wa bc bcd 42 5 5 PREPARATIONS BEFORE ANALYSIS iecit dioe v d dE OCC c OD E E d a b a LO brc o 42 5 6 ANALYSIS 5 6 1 Introduction 5 6 2 Sample Identification 5 63 Sample FUN e dette det ie eR RE eie Lene Re REN de MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 7 84 REF M18C UM EN 012 ccm 5 8 PRINTING 5 8 1 Model report A4 external printer m n 5 8 2 Model rep
39. SION RELERSE MYTHIC NUMBER This menu is reserved biologist see section 3 1 Any modifications can affect the quality of the results We recommend modifying these values only after an Orph e s training Please refer below for the description of each key 3 4 1 Printer set up AUTO PRINT STRRTUP Printer set up menu is intended to present the printing report To select an option on the report press on the corresponding case To enter a header press Ha key To exit the menu either press Esc to keep the last setting or _vau PRINT v NORMAL LIMITS v PRTHOLOSIES to save the last modifications HEADER v FLAGS v COMMENTS v CURVES v UNITS HERDER 8 E PREVIOUS SCREEN TOOLS MENU Reserved for technical Service people To set up the connection between MYTHIC and Host or between MYTHIC YOu ARE NOT ALLOWED TO and SVM Validation Station for MYTHIC ACCESS TO THIS MENU LAB PARAMETERS CALIBRATION FACTORS OTHER SETTINGS STORRGE OPTIONS UERSION RELERSE MYTHIC NUMBER 26 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 3 INSTRUMENT SET UP 3 4 3 Analysis options PREUTOUS 22799 OPTIONS box o ALWAYS ID and ALWAYS PID To run a sample user mandatory OPTIONS RUO needs to enter a ID and or a PID ALWAYS PID us MODE o R
40. TION QUALITY CONTROL RESULTS SET UP SERUICE OPERATOR LOG OUT STRRT UP To rinse the system before analysis press The cycle LED turns red None cycle can be performed before it turns green Mythic will perform 1 to 3 empty cycles to check the carry over level This level should not to exceed the following ratios WBC 0 5 RERGENTS Logs RUN SAMPLE HGB 0 5 PLT 10 If the level is higher MYTHIC 18 proposes to perform a new start up or to escape If the user chooses to escape every result will be printed with Start Up not done message 5 5 PREPARATIONS BEFORE ANALYSIS The human blood venous sample must be collected in an EDTA K3 Ethylene Diamine Tetracetic Acid tri potassic tube in sufficient quantity The LMG results are available for six hours after the blood draw The use of EDTA K2 leads to a poor quality 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 quantity of anticoagulant or a bad mixing may involve an erroneous result 5 6 ANALYSIS 5 6 1 Introduction QC and possibly a calibration before any analysis see section 6 amp 7 It is recommended or mandatory according to the legislation to carry out a Quality Control If the quality control is not carried
41. UM EN 012 1 5 CONNECTION CHANGE AND PRIMING REAGENTS MYTHIC 18 works with the reagents described in section 4 3 Some commercial reagents can also be used Please contact your Orph e s representative 1 5 1 Connection Lysis reagent and cleaning solution Before handling the reagents read carefully their specifications described in section 4 3 Remove the door on the left side of the instrument Put the reagent bottles in the dedicated location Remove the caps of the bottles Tighten the yellow caps on the Lysis bottle yellow sticker and the blue one on the cleaning solution bottle blue sticker Diluent and waste Connect the diluent tube male connector on the outlet on the bottom and tighten the cap on the diluent container To use a 20 liter diluent container adds the tubing straw adaptor supplied with the installation kit Connect the waste tube female connector on the outlet on the Diluent top and tighten the cap on an empty container Do not modify the type and the length of the diluent and waste tubes The diluent must be placed at the same level as the MYTHIC 18 Collect the waste in a container and treat it in compliance with your local legislation Example of neutralization procedure usually used in a laboratory For 20 liters of waste produced by the MYTHIC 18 add 50 ml of a solution of sodium hydroxide NaOH at 200g l mix
42. UO With tag the PCT and PDW parameters are displayed STARTUP ALARMS ABSOLUTE LNG printed and sent o US MODE The Research Use Only message is printing below the printing report only if RUO is tagged o ABSOLUTE LMG With tag absolute values for sub populations of leucocytes are displayed In the other case percentages are ALARMS UNITS srenonno BAR CODE READER PID C ID C SID BOLD DISPLAY 0 DIL displayed V REJECT o QC ALARMS The message QC failed appear below the printing v PANIC HIGH v PANIC LOU A 7 LIMIT HIGH LIMIT Low report when the QC result is out of tolerance or expired The message QC not done appear below the printing report when it is not run STANDARD UNITS Gives a choice of three unit systems Standard International System and mmol CDB box The bar code reader is dedicated to the PID ID or SID BOLD DISPLAY box display and print in bold faced type the different Choices in this box Once modifications are done press either uum to validate your choices or Esc to exit keeping the previous setting 3 4 4 Lab parameters STRNDRRD LIMITS THRESHOLDS STANDARD Select the blood type in the combo box press EIE to adjust the normal and panic limits see section 3 4 4 1 THRESHOLDS Tene to adjust the parameters thresholds see section 3 4 4 2 RRE to adjust
43. al results memory have not been sent before the DO YOU WANT TO SEND 18 was switched off Press YES to send them immediately or press LATER to wait at another time or NO if you do not want to send them No USB key is available connect an USB key then press YES or see section 3 4 7 to change the archive mode Press Peu e The MYTHIC 18 performs a complete priming cycle The cycle LED w turns red No cycle can be performed before it turns green AUTONOMY run AUTONOMY run indicates the number of samples runs To prime or to know the quantity of reagent press the dedicated button Press Ll to visualize the cycle counters CYCLES COUNTER RUNS 115 STRRTUP 12 SHUT DOWN The reset of the counter is allowed by an Orph e s representative only Page 14 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 1 INSTALLATION DILUENT PRIME PREVIOUS lt 3 22709 SCREEN MENU 8 9 DILUENT LOT EXPIRY 28 19184 CAPACITY ml 200 0 19000 CHANGE REAGENT PRIME DILUENT ssf Le RERGENTS From the MAIN MENU press m cam then DILUENT to have access this screen Enter lot number the expiry date and the container capacity CHANGE REAGENT Press to validate the new entry or after changing a new container with the same information After the replacement a new container or to pr
44. blood should be run Only the reagents mentioned in this manual are permitted to use The optimum performances can be only achieved if the cleaning and maintenance procedures are carefully followed c Due to the use of this equipment all parts and surfaces of the MYTHIC 18 are potentially infective Wearing rubber gloves is highly recommended and after completion of work washes hands with disinfectant gt Always replace or use parts of the equipment by parts supplied by ORPHEE distributor Basic safety precautions should always be taken If the equipment is not used according to the manufacturer s instructions the protective by the equipment may be impaired c The treatment of waste and the elimination of a part or the complete instrument must be done in compliance with the local legislation c Any output or input connections except the printer and the barcode reader supplied by ORPHEE cannot be done without the ORPHEE representative authorization c Do not open the door located on the right side of the instrument see section 1 1 3 when a hydraulic cycle is in progress for it would lead to an immediate stop To re start shut the door and run a Control cycle see section 9 3 1 KEEP THESE INSTRUCTIONS MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 3 84 REF M18C UM EN 012 This equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC
45. ccessful Bad stability HCT amp PLT too Perform a 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 HGB No results Check the led light on Bad stability Check if no bubble the lysis tubing Check the level bubble flow in the WBC bath during the run cycle Rejection Close the door Perform a new Start Up cycle Page 78 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 9 SERVICE 9 5 2 Other problems ORIGIN PROBLEMS SOLUTIONS MYTHIC 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 4 2 No starting Check the power supply connection wires All results bad Check the level diluent and if the supply tubing is pinched Check if the diluent is placed at the same level as the MYTHIC 18 No display Check the flat cable ID and or PID typing ID and or PID are mandatory see section 3 4 3 impossible Message cycle pressure Check the level of the reagents check the tubing default or Flag INS P connection of the fluidics Printer No printing Check the paper Check the electrical connection Bad printing Check the black ribbon 9 6 TROUBLESHOOTI
46. culated method CV SD X Xx N N 1 MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 33 84 4 SPECIFICATIONS REF M8C UM EN 012 Carry Over For each parameter we perform 3 runs from high concentration sample followed by 3 runs from empty cycles WBC RBC HGB PLT High concentration value 18 0 5 33 17 9 466 Measured carry over 0 0 18 0 0 6 Maximum carry over 10 10 10 10 The percentage of carry over inter samples is calculated with the following formula Result empty cycle 1 Result empty cycle 3 Carry over x 100 Sample 3 Result empty cycle 3 Accuracy Correlation with one commercial instrument ABX PENTRA 120 and with 100 normal blood samples without alarm for all the parameters except LMG Correlation with one commercial instrument ABX MICROS 60 and with 31 normal blood samples for LMG PARAMETERS N R WBC 10 mm 97 0 9985 LYM 25 31 0 9801 MON 31 0 9533 31 0 9860 RBC 105 mm 99 0 9958 HGB g dL 99 0 9973 HCT 99 0 9898 MCV fL 99 0 9783 RDW 99 0 6000 MCH pg 99 0 9789 MCHC g dL 99 0 4020 PLT 103 mm 99 0 9940 MPV fL 99 0 9196 2x Xy Calculated method rz 5 Zx n Zy2 5 2 Page 34 84 Copyright Orph e
47. d connection 24 Equipotentiality V Any output or input connections except the printer and the bar code reader supplied by ORPHEE cannot be done without the ORPHEE representative authorization 1 3 1 Power supply block MYTHIC 18 must be connected to the power with the power supply block provided with the starter kit Choose a well ventilated place for the block and be sure to connect this power supply in a socket outlet with a correct earth connection The power supply block must be placed at the rear of the MYTHIC 18 and if possible in an upper position to avoid the contact with any liquid To disconnect electrically the 18 remove the power supply plug from the main circuit In the case of replacement of the main power wire supplied with the MYTHIC 18 the new f one must comply with the local regulation 3 1 5mm cable and 250V 10 plug 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 your Orph e s representative 1 4 PRINTER CONNECTION Connect the printer cable in conformity with the printer user s manual Use the parallel rear plug of the MYTHIC 18 or the USB plug s to connect the printer cable Select the printer driver section 3 3 MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 11 84 1 INSTALLATION REF M18C
48. damage to the carrier Open the box on the top remove the starter kit Remove the MYTHIC 18 from the box Starter kit contents INSTALLATION KIT QTY Designation Part Number 1 M18 DILUENT 005 1001 90 23 1 M18 WASTE 005 1001 90 24 1 70W switching adapter 050 1001 01 70 24 1 European Power line cord 150 2001 CEE C13 1000 2 5 10 20L Adaptator 300 1009 05 1020 1 M18C User manual 605 1201 02 1 Screwdriver Slot 1 4 700 7101 02 MAINTENANCE KIT QTY Designation Part Number 1 Tygon tubing L 1000mm 1 52x3 2mm 005 1001 90 016 032 1 Tygon tubing L 500mm 2 06x4mm 005 1001 90 020 040 1 Tubing 9 005 1001 90 09 1 Tubing 10 005 1001 90 10 5 Cables Ties 153 0101 100 25 2 O ring 013 1 1 6 Fluocarbon 80SH 312 0505 1310 160 1 O ring 01 4 1 25 Fluocarbon 80SH 312 0505 140 125 010 2 O ring 5x1 Fluocarbon 80SH 312 0505 500 100 1 Silicon grease 3gr 410 0501 02 02 1 Short Arm TORX T10 Tool 700 1101 10 1 Short Arm TORX T20 Tool 700 1101 20 MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 9 84 1 INSTALLATION REF M18C UM EN 012 1 1 3 Visual checking e Open the door on the right side with the key provided in the kit To be checked 1 Counting chambers perfectly locked in their manifold locations 2 Needle s dismountable system located in the rocker 3 Rocker in front po
49. e 1 3 1 Power supply block s T 1 4 PRENTEB CONNECTION rene se n RE ERR ERREUR at nr re die tete petens dedu 1 5 CONNECTION CHANGE AND PRIMING REAGENTS 1 5 1 Connection d s ae a LO Z PRIMING MH G PH 1 6 TRANSPORTATION AND STORAGE decetero eet ete ete eoa epa edd m dag 2 GENERAL OVERVIEW 2 I GENERAEETIESA 2 2 OVERVIEW 2 3 MAIN PART DESCRIPTION T m n T 2 31 Display Keyboard oa eoe d a AERE ER HIE ete e He E eta En 2 3 2 Dilution hydraulic partes tien dee ede te e Redde 2 3 3 Mono electronic board ee tet ten cest ves oes ive cocer eeu eee 2 34 Power Supply Block eda etre e HS EHE ORI GEI RESI UTOR ed 2 3 9 Tray sedeecevedtotne ede edtioetvademecdieibedeedi tredelgside eritielesedeo tpa en ete b trend 3 INSTRUMENT SET UP 31 USER S TDENTIFICATION a tcn tata teta deer eb da bcne door a caen ce dare a teta oss nate e LS tt SE ater mel 3 2 TUpPOCess EUER BRI D t TT RIA dU 3 0 SYSTEM STATUS S23 SET UP e M 4 SPECIFICATIONS 4 1 aR akinak 33 A 2 PHYSICAL S
50. e initialization menu is displayed and MYTHIC 18 performs a home position checking for the three motors The cycle LED turns red None cycle can be performed before it turns green mm Enter your login and password as described in section 3 1 PASSWORD 1 a z gt AUTONOMY run indicates the number of samples runs you can perform calculated with the smaller quantity of reagents AUTONOMY run 12 WARNING If this window appears it means that several results in memory have not been sent before the MY THIC 18 was switched off iE Press YES to send them immediately or press LATER to wait at another time or NO if you do not want send them LRTER ves Page 40 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 5 SAMPLE ANALYSIS No USB key is available connect an USB key then press YES or see section 3 4 7 EXTERNAL STO to change the archive mode TO BE MOVED TOOLS MENU If one or more reagent needs to be replaced proceed as indicated in section 1 5 2 AUTONOMY run indicates the number of samples runs you can perform calculated with the smaller quantity of reagents MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 41 84 5 SAMPLE ANALYSIS REF M18C UM EN 012 5 4 START UP RINSING PREVIOUS mer STRRT UP SHUT DOWN CRLIBRR
51. e result press 5 To send the result press gt EXIT To close the window press FLAGS 1 5 FRIFR2 FPiFPS STARTUP FR L2FL ILED GC FAILED SID 00001 TYPE STANDARD 5 8 PRINTING Once the analysis is finished the MYTHIC 18 prints a result report To modify the printing presentation or to disconnect the printer see section 3 4 1 5 8 1 Model report A4 external printer EPSON LX 300 model ORPHEE MEDICAL Presentation Results MYTHIC 18 5 8 2 Model report Ticket printer SEIKO DPU 414 model ORPHEE HEDICRL Presentation Results 18 DUPONT 31 18 2084 Patient Id X28 13 15 03 Sample Id 60100 Type STANDARD Name RHEROLE Patient Id 53487 C Sample Id 80450 onmen ts i Type STRNDRRD Seat 02587 Operator ID WBC 11 0 10 37p L 4 0 7 12 0 HNO LS HIS Ge Le Sas 69925250 Operator ID Date 01 11 2004 10 01 00 Seqt 84531 Grae CE 5592809 RBC 6 00 18 67pl 4 00 6 20 mE HGB 15 0 g dl 11 807 17 0 Result Flags Unit Normal Limits m Qu WBC 9 0 18 37pl 4 9 7 12 8 EU ELE LUE LYM 38 6 10 3 p 1 9 7 5 0 ei 100 1807 168 MON 1 6 H 10 34 8 1 1 8 BU pe pma 780 GRA 4 2 18 87pl 2 0 8 0 6 402 0 208 0 600 21 resins GRAZ 46 5 58 0 88 8 REC 5 30 10 67p L 4 88 6 20 HGB 14 8 g dl 11 8 7 17 8 HCT 45 6 2 35 0 55 8 MCU 88 8 pm 8 88 8 100 0 33 0 pa 26 0 8
52. e system towards outside 2 Remove the tubing fixed at the end of the needle Unscrew the serrated roller which maintains the seal and the needle Leave the serrated roller the needle and the o ring from the rinsing head MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 73 84 9 SERVICE REF M8C UM EN 012 Remove the o ring Replace the needle with or the o ring REASSEMBLY PROCEDURE To reassemble the unit carry out the various operations in the opposite direction Place the seal on the needle gently not to wound it 9 4 3 Baths dismantling This procedure must be carried out to replace the bath seals on the manifold or the aperture seals A Wear rubber gloves and wash hands with a disinfectant after completion of work PREVIOUS S m 22 09 From the MAIN MENU press E press Press to perform a draining of the counting baths Open the door located on the right side of the instrument to have access EU to the hydraulic part Page 74 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 9 SERVICE To remove the counting bath module very carefully and slowly draw on the clip 1 while pushing the top from the counting bath towards the inside of the machine 2 Then upwards raise the counting module Next remo
53. ed eee e be eee endo 8 2 LEUCOCYTE ANALY SES RC rio le ei Ree D 8 3 ERYTHROCYTE ANALYSIS 8 4 ANALYSIS OF PLATELETS 8 5 5 8 5 1 General Flags us n si a s 8 5b 2 e kocytes Flags os cete eR Ste ENTER tem OO e ER ee RH eem 8 5 3 Erythrocyte and HGB EORR AERE URS 8 5 4 Platelet Flags ERR eR ERR ee ER TER EUM e TOREM UR ET eo 8 2 5 Machine 8 6 HYDRAULIC DESCRIPTION dae ma e a oH ae acea dae eaa aHa oa mr 8 61 module eec tse ite ee ihe de ete Rhe PRU ede ee Renee rhe retento de 8 6 2 Co nting bathimodu le RU ei M o cR t EE 8 6 3 Syringes module 8 7 SOFTWARE 8 8 1 Windows s d s 8 8 2 Menu free ED 9 SERVICE PAN MAINTENANCE UE GAT Maintenance ne 91 2 ON Die TAYDRAULIG CYCLES re de E P ute e tae e 9 3 MECHANICS 9 4 9 4 1 Emergency stop 9 4
54. he led to check it See section 9 4 2 ___WentcaTion Ise section 9 1 3 Page 70 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 9 SERVICE To test each valve press the dedicated button To test all the valves press 9 4 REPAIRING 9 4 1 Emergency stop In case of mechanical or hydraulic problem immediately press e the MYTHIC 18 will make an emergency stop TOOLS MENU After having identified the problem it is necessary to perform a Control cycle To have access to this cycle press eR 4 from the MAIN MENU then press MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 71 84 9 SERVICE REF M8C UM EN 012 9 4 2 Needle or o ring replacement A Wear rubber gloves and wash hands with a disinfectant after completion of work From the main menu press to go to the display described on the left Press on The rocker places the sampling needle in the disassembling position Open the door located on the right side to have access to the hydraulic part Wait for the information window and then open the door The needle is in front of the counting chambers Remove the sampling module while slightly lowering the clip 1 to the bottom Page 72 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 9 SERVICE Draw th
55. ime the diluent press PRIME DILUENT A new entry is automatically done in the logs see section 5 9 LYSE AND CLEANER PRIME Proceed as described above for the diluent WASTE Enter only the capacity of the container WASTE CAPACITY ml 9500 0 After replacement of the waste container press RESET to reset to initialize the waste calculation pan MYTHIC 18 IS NOW READY TO WORK 1 6 TRANSPORTATION AND STORAGE Storage temperature 10 C to 50 C Before transportation outside the laboratory perform a complete cleaning with a disinfectant in compliance with the local legislation MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 15 84 2 GENERAL OVERVIEW REF M18C UM EN 012 2 GENERAL OVERVIEW 2 1 GENERALITIES MYTHIC 18 isa fully automated analyzer performing hematological analysis on whole blood collected on EDTA tubes Sample volume 9 8 pl Throughput 60 samples hour 18 analysis parameters Leukocyte parameters WBC LYM LYM MON MON GRA GRA White Blood Cells Lymphocytes in percentage Lymphocytes Monocytes in percentage Monocytes Granulocytes in percentage Granulocytes Erythrocyte parameters RBC HGB HCT MCV MCH MCHC RDW Red Blood Cells Hemoglobin Hematocrit Mean Corpuscular Volume Mean Corpuscular Hemoglobin Mean Corpuscular Hemoglobin Concentration Red Blood cells Distrib
56. ion 8 To validate the new values press VALID key in the next page see below Once modifications are done press _vau to validate or 252 to exit without any modification Press LI ver to return to the manufacturer parameter setting Example of reference values from LABORATOIRE D HEMATOLOGIE DU C H U D ANGERS FRANCE 8 days to 3 3 months to First week 3 to 6 years 6 to 15 years Adult months 3 years WBC 10 uL 10 L 10 0 to 30 0 6 0 to 18 0 6 0 to 15 0 5 0 to 13 0 5 0 to 11 0 40 to 10 0 Neutrophiles 10 pL 6 0 to 26 0 15 to 8 5 15 to 8 5 15 to 8 5 1 8 to 8 0 18107 5 Eosinophiles 10 u 0 2 to 0 85 0 2 to 12 0 05 to 0 7 0 02 to 0 65 0 to 06 0 04 to 0 8 Basophiles 10 pL O to 0 64 O to 0 2 0100 2 0100 2 O to 0 2 O to 0 2 Lymphocytes 10 uL 2010110 2010110 4 0 to 10 5 20 to 8 0 15 to 65 10104 5 Monocytes 10 uL 0 4 to 3 1 0 05 to 1 1 0100 8 0100 8 O to 0 8 0 2 to 10 M 4 5 to 5 8 6 12 RBC 10 pL 10 1 5 0 to 6 0 3 8 to 4 8 3 6 to 5 2 41 to 5 3 40 to 5 4 F 381054 H 13 5 to 17 5 H6B g dL 14 5 to 22 5 10 to 16 10 5 135 105 to 13 5 11 5 to 14 5 2 12510155 o M 40 to 50 HCT 44 to 58 38 to 44 36 to 44 36 to 44 37 to 45 37 to 47 MCV fl 100 to 120 85 to 96 70 to 86 73 to 89 77 to 91 82 to 98 MCH pg 34 to 38 24 to 34 23 to 31 24 to 30 24 to 30 gt 27 MCHC g dL 32 to 36 32 to 36 32 to 36 32 to 36 32 to 36 32 to 36 PLT
57. k the results and flags Once modifications are done press _vau to validate or lt to exit without any modification Press Lr oer to return to the manufacturer parameter setting In the Alarm menu users can modify the sensitivity of the alarms for the different cells WBC RBC and PLT Once modifications are done press _vau to validate or _ESC to exit without any modification Press ner to return to the manufacturer parameter setting Copyright Orph e SA All Rights Reserved Page 29 84 3 INSTRUMENT SET UP REF M18C UM EN 012 3 4 4 5 Correction factors TOOLS MENU 2 2 This function can be reached only for any other type than the standard In this menu for each blood type users can define a correction factor which is multiplied by the calibration factor given by a normal calibration see section 7 5 co 9 co olo c Once modifications are done press _vau to validate or to exit without any modification 3 4 4 4 Rename Types PREVIOUS E 2 In the Blood type menu users can the limits thresholds alarms and calibration correction factors associated to each blood type To modify the name of the blood type Select the type Press Rz Input the new 55 to validate Esc to exit without any modification BLOOD TYPE
58. lay and keyboard Connexion mode RS232 Ethernet Printer Measurement Counting hemoglobin measurement processing External barcode reader A To avoid all deterioration risks only the service people can touch this electronic board 2 3 4 Power Supply Block a 4 fim forma A 60 G E 5 IE Tt 2 5 3 S E 5 S 8 2 D E 7 E 5 OUTPUT 24V 3 04 For with Intormation Techsalogy Equipment CAUTION USE ONLY MYTHIC 18 is supplied with an external power supply block In the 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 your Orph e s representative MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 21 84 2 GENERAL OVERVIEW REF M18C UM EN 012 2 3 5 Reagent tray The reagent tray is dedicated for the lysis and cleaning solution bottles Page 22 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 3 INSTRUMENT SET UP 3 INSTRUMENT SET UP 3 1 USER S IDENTIFICATION 3 11 Start Up After the instrument s initialization the identification window is LOG
59. mula approach is obtained by WBC distribution curve analysis after action of the lytic reagent This reagent destroys the RBC and their stromas and acts on the white blood cell cytoplasmic walls E In this case lymphocytes are between the beginning of the curve and M1 monocytes between M1 and 2 and granulocytes higher than M2 When the WBC result is lower than 1 0 103 the lymphocytes monocytes and granulocytes results and the curve do not appear MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 59 84 8 REF M8C UM EN 012 8 3 ERYTHROCYTE ANALYSIS The erythrocyte analysis is done by impedancemetry in the RBC counting chamber and by analysis of the hemoglobin inside WBC chamber as previously described Seven parameters are obtained Parameters Pathologies adjustment section 3 4 4 1 RBC Red Blood Cells Erythrocytosis RBC gt RBC h HGB Hemoglobin Anemia HGB HGB b HCT Hematocrit MCV Mean Corpuscular Volume Microcytosis VMC lt VMC b Macrocytosis h MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration Hypochromia MCHC MCHC b Cold Agglutinin MCHC gt MCHC h RDW jRed blood cells Distribution Width Anisocytosis 1 RDW gt RDW h1 Hematocrit HCT is measured by integration volume of all of the red blood cells which flow in the RBC counting chamber aperture MCV is obtained by calc
60. mythic 18 mythic 16 19 Chemin du champ des Filles 1228 Plan Les Ouates SWITZERLAND Tel 41 0 22 884 90 90 Fax 41 0 22 884 90 99 Web Site www orphee medical com Cod M18 UM EN 001 REF M18C UM EN 012 REVISIONS 27 04 04 Creation 22 06 04 All sections modified 09 07 04 5 All sections modified 10 09 04 6 Sections 4 1 9 5 8 5 1 modified 13 09 04 6 Sections 4 1 5 7 1 9 6 9 7 modified 08 10 04 6 Sections 5 7 11 10 04 6 Safety instructions pages 3 60 et 62 25 10 04 6 Sections 1 5 1 5 5 modified 18 02 05 0 Sections 1 5 2 3 1 1 5 6 2 5 1 0 modified 28 10 05 0 Sections 1 1 2 4 1 modified WEEE page 4 05 03 07 Add USB key management sections 5 10 6 7 Printer management section 3 3 4 15 10 08 pages new color screen CONTACT ADDRESS MANUFACTURER Manufactured in France for ORPHEE SA 19 chemin du champ des filles CH 1228 Geneva Plan les Ouates SWITZERLAND Tel 41 0 22 706 1840 Fax 41 0 22 794 4391 http www orphee medical com LOCAL AGENT Page 2 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 READ THIS BEFORE USING THE EQUIPMENT WARNING 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 quality of results Indicates that wearing gloves is mandatory before performing the desc
61. n 15 00 Consumption with one run sample add one two run sample consumption if needed The consumption of the lysis is given for the ORPHEE reagent with a standard adjustment To change the quantity to use another lysis please contact your ORPHEE representative POWER SUPPLY BLOCK Dimensions Height 31 mm approx Width 58 5 mm approx Depth 132 mm approx Weight 0 35 kg approx Power supply Input 100 to 240V AC 15A 50 60Hz PRINTER LX 300 Dimensions Height 164 mm approx Width 366 mm approx Depth 275 mm approx Weight 4 4 kg approx Power supply Model 120V Model 220 240V 99 to 132Vac 198 to 264Vac 50 to 60 Hz Electric consumption 23W approx Paper size 4 Printer Impact 9 needles Speed Up to 300 cps character per second Page 36 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 4 SPECIFICATIONS 4 3 REAGENTS SPECIFICATIONS All the reagents must be stored at room temperature 15 C to 25 C 4 3 1 Diluent ORPHEE code number HM18 003 10 Shelf life once opened 60 days Application The diluent is used to carry out the necessary dilutions for the measurement performed by the MYTHIC 18 see section 8 Active components 0 45 Sodium Chloride 100 Sodium Sulfate Others components Buffer Preservative Description Clear and odorless aqueous solution Storage At room temperature until the expi
62. n 8 Components Enzyme Potassium and Sodium salts Surfactant and preservatives Coloring agent Description Clear aqueous solution blue color Storage At room temperature until expiry date labeled on the bottle Precautions Can cause skin and eyes irritation Wear on a smock gloves and glasses during manipulation First emergency care Inhalation Breathe fresh air Eyes To rinse abundantly during 15 mn Skin To rinse abundantly Ingestion Vomit If any doubt call an emergency center Page 38 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 4 SPECIFICATIONS 4 4 ANALYTICAL LIMITATIONS 4 3 1 Recommendations MAINTENANCE Please respect the maintenance procedure and the quality control procedure Otherwise results can be affected GENERALITIES Some abnormal samples may give incorrect results by automated cell counting methods The following table Shows examples of specific specimens that could cause errors Each result for a new patient out of lab linearity limits or with an alarm must be checked with a conventional method or checked with blood smear 4 3 1 Interferences Parameter Specimen Possible Indication of Error WBC Cold Agglutinin TMCV LHCT red cell clumping on smear Nucleated RBC NRBC on smear Cryoglobulins Platelet aggregation Platelet aggregates on smear Erythroblastosis Eryth
63. nge for another USB Thumb Try again or change for another USB Thumb Try again or change for another USB Thumb Delete some files Please connect USB thumb drive to the analyzer Delete some files Try again or change for another USB Thumb Try again or change for another USB Thumb Try again or change for another USB Thumb Re start the Mythic Press OK Perform a new start up cycle This MY THIC cannot be connected to the SVM XB alarm Call an Orph e representative System is resetting after version release Re start the Mythic Replace the container and perform a prime Diluent Try again or change for another USB Thumb Try again or change for another USB Thumb Select the correct version Replace the waste container MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 81 84 9 SERVICE REF M18C UM EN 012 9 7 LOGS ERRORS zi From the MAIN MENU press 5 LOG ERRORS Then press MOTOR INIT HYDRAULICS MECHANICS REPEATABILITY LOG ERRORS TECHNICIAN ___ __ 03786 20 51 057 VSE ALMOST E 94706 04 09 258 LEANER 5 25 06 12 27 859 ALMOST 6 86 28 45 860 HE DILUENT U 87796 84 83 861 LYSE USED 05706 12 21 062 HE CLEANER U 09706 20 33 063 STET EEPRO 18786 84 57 9
64. nt 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 8 6 3 Syringes module This module patent pending enables to draw the sample to distribute 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 MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 63 84 8 REF M8C UM EN 012 8 7 SOFTWARE 8 8 1 Windows Common keys This three keys allows to come back to the previous display are always present in all screen MENU EIN allows to come back to the MENU display where ever you are in the arborescence TOOLS depends on the screen it allows to open a window dedicated to perform an action for example to select information to print send or delete it Windows CYCLE VALVE 1 FAILED DELETING RESULTS NTER DRIVER n HRS BEEN UPLORDED TOCOTINON Y SU ULLV LE t UPDATE KCEE
65. o be replaced With the help of the provided tool in the maintenance kit unscrew the screw and remove the connection NOTA This operation can be performed without dismantling the complete bath block MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 77 84 9 SERVICE REF M18C UM EN 012 part Remove the o ring and replace by a new one or replace the whole NOTA The WBC aperture block is marked with a figure 8 on the ear and with a figure 5 for the RBC REASSEMBLY PROCEDURE To reassemble the unit carry out the various operations in the opposite direction Place the seal on the aperture block gently not to wound it 9 5 TROUBLESHOOTING In any case if a problem is not solved call Orph e s representative 9 5 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 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 then a Bleach cycle if unsuccessful Check the level bubble flow in the WBC bath during the run cycle RBC No results No HCT amp PLT Check the bath wires Perform a Cleaning Cycle and then a Bleach cycle if unsu
66. ompletion of work 9 1 MAINTENANCE 9 1 1 Maintenance table NOTA This table is made for an average number of 50 samples day For more please increase proportionally the number of maintenances MAINTENANCE DAILY WEEKLY MONTHLY HALF A YEAR ANNUALLY User Tech User Tech User Tech User Tech User Tech Reagents level X Start Up X Automatic cleaning X Concentrate cleaning X Shut down X Cover cleaning X Piston greasing X X Needle greasing X Needle o ring replacement X Syringes o ring replacement X Motor screw greasing X Reagents level control see section 5 1 Start up see section 5 2 Automatic Cleaning The cleaning is automatically performed by the MYTHIC 18 following the set up defined by the user see section 3 3 6 the standard value is 80 Increase the frequency of the cleaning of the MYTHIC 18 in case of analyzes of pathological samples or if there are too many flags and too often Concentrated cleaning see section 9 1 1 Shut down see section 5 11 Cover cleaning Clean the cover above and around the sampling needle with a wet paper with a disinfectant to eliminate the blood trace Piston greasing see section 9 1 3 9 1 2 Concentrate cleaning This cleaning is necessary when MYTHIC 18 is in permanent rejection for one measured parameter Prepare a Sodium Hypochlorite
67. onsult Organo incaric della valutaz della conform se consultato Notified Body if consulted Ort Datum Lieu date Luogo data Place date Gen ve le 06 Juin 2008 REF M18C UM EN 012 IEC 60601 1 2 2001 EN 61000 3 2 EN 61000 3 3 EN 61000 4 2 95 A1 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 1 01 EN 55011 Class B EN 55022 Class B IEC 61010 1 2001 IEC 61010 2 081 2001 IEC 61010 2 101 2002 Annex III N A Name und Funktion Nom et fonction Nome e funzione Name and function Philippe Daire RA amp QA Copyright Orph e SA All Rights Reserved Page 6 84 MYTHIC 18 REF M18C UM EN 012 TABLE OF CONTENTS 1 INSTALLATION 1 T EE LL Introductio RR eda vede lila ati vede ae M e EET NN 11 2 Unpacking Procedure e E ree PDS Visual Tes RAR mme L2 INSTALLATION CONSTRAINTS L2 A Enstallation place E RO RR NUT rA e LC TE 1 2 2 Tnstallation environment nli dr tee ri eer eee pe ry decebat sry desee eset rr de 1 3 ELECTRICAL CONNECTIONS ne
68. ort Ticket printer ua cese dena cene tense ee me o M ever a Dee AM ul c M Ner irai ee 5101 Results M E TD A SUEDE DU A E TINS TAND AND SH T DOWN 6 QUALITY CONTROL OT ENTRODUGTION S seem pb et ted e e eee eed em ede remite pa e maet 6 21 M 6 2 2 Run control blood rete nn RR RAT eec 6 223 ene tete eter a edo pte pede e tees re pitis be erint ee peel eed 6 2 4 Restore ain o eR ARRA REO n Da RE 6 3 REPEAT nho M 7 CALIBRATION TA RESULTS e RAI GARA SUO SERRA RISO aan cam an can SIR RUNS RIBERA anc ancman cman cn ancnancnancnancnaney 7 11 Calibration blood analysis eie hee iii ree npe ehe bee ene denis 7 1 2 7 2 TARGET VALUE MODIFICATIONS 8 TECHNOLOGY DETECTION PRINCIPLE ett ste ete ete aesti te este ote te este ete reet ete dre dietis ete iade ted 8 1 1 WBC RBC PLT Counting i 8 52 Hemoglobin measurement saines eee Tee ehe a
69. out it is recommended to perform two analyses on a normal sample of the day before before beginning the series NOTA The MYTHIC 18 is delivered with a standard parameter setting described in section 3 Page 42 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 5 SAMPLE ANALYSIS 5 6 2 Sample Identification __ RUN SAMPLE From the main menu press to reach START UP SHUT DOWN the analysis display CRLIBRRTION QUALITY CONTROL RESULTS SET UP SERVICE OPERATOR LOG OUT RERGENTS LOGS RUN SAMPLE This prompt appears when the results memory is almost full To avoid this message select the option FIFO mode in the set up This prompt appears when the results memory is totally full To delete results see section 5 1 The display bottom is reserved for the entry of the next sample ID 66706 66 66 PIB TN upc identification to run 9 Three fields allow the entry of the identification P GRAZ ID Patient Name 20 characters max PID Patient Identification 16 characters max SID Sample identification 16 characters max zi E coc ID MOON ICAO c uere OOOO COOOOOO OOOO D m e NOTA SID number is already done see section 3 2 IDENTIFICATION PROCEDURE To enter or modify identification place the cursor in the selected field with your finger o
70. r the arrow To enter a figure use the keyboard on the right of the screen for a 510 00001 letter use the alphabetic keyboard by pressing lt lt accede to another character page press or gt i TYPE STANDARD To change the blood type press the combo box and select the type To valid the entry and return to the previous screen press Lm ESC To return to the previous screen without validation press MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 43 84 5 SAMPLE ANALYSIS REF M18C UM EN 012 5 6 3 Sample run If the needle is not visible first presses the start cycle trigger and wait for the descent X Xx Present the tube of the blood sample under the needle and oo x press the start cycle trigger The cycle LED located at the top of the needle becomes red the tube can be removed only when the needle up A new cycle can be started again when it turns by again green Wear rubber gloves and wash hands with a disinfectant after completion of work Start cycle trigger As soon as the cycle is launched the SID is incremented automatically 0 00 00 09 and thanks to its data processing multitasks the MYTHIC 18 is available for the identification of the following sample see section 5 6 2 mi 0D J a 2
71. rform an initialization or a control cycle Re start the Mythic Call an Orph e representative Switch on the printer or invalidate the printings Switch on the printer or invalidate the printings Delete some files Select the correct version Switch on the printer or invalidate the printings Switch on the printer or invalidate the printings Switch on the printer or invalidate the printings Add some paper Perform a clean cycle Re start the Mythic Re start the Mythic Page 80 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 9 SERVICE MESSAGE ACTION 5232 SYNCHRO ERROR RUNNING AUTO CLEANING SYSTEM DOWNLOADING NEW VERSION PLEASE WAIT THE LYSE USED 15 OUT OF DATE USB DIRECTORY IS NOT EMPTY USB THUMB DRIVE IS FULL USB UNABLE TO CREATE DIRECTORY USB WRITE PROTECTED FILE 4 4222 RELEASE IS COMPATIBLE WITH THE MYTHIC 22 SYSTEM WASTE ALMOST FULL Re start the Mythic You have to be Logged with the good access code Perform a start up cycle Update the SVM software Re start the SVM Re enter the file or confirm it manual connection on the SVM Westgard alarm Re start the Mythic Re start the Mythic Replace the bottle and perform a prime Cleaner Replace the bottle and perform a prime Lysis Try again or cha
72. ribed operation due to risk of contact with materials that may be infectious NOTA Indicates important additional information DANGER Misuse of electrical equipment may cause electrocution burns fire and other hazards gt Check that the voltage setting matches the supply voltage gt Protective earthing is required plug the MYTHIC 18 into a supply outlet which has an earth connection c Preserve a good access to the supply outlet to be able to unplug the MY THIC 18 in emergency case c Do not place the power supply adapter in liquid nor put it where it could fall into liquid If the power supply adapter becomes wet unplug it before touching it gt Do not use the MYTHIC 18 if it is not working properly or if it has suffered any damage damage to the supply cord or its plug damaged caused by dropping the power supply adapter gt Do not let the power supply adapter or its flexible cord come into contact with surfaces which are too hot to touch gt Do not place anything on top of the 18 gt Do not use the MYTHIC 18 where aerosol sprays are being used or where oxygen is being administered c Do not use the MYTHIC 18 out of doors gt Always switch off the MYTHIC 18 and disconnect the power adaptor before dismantling any part gt The MYTHIC 18 is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories by an authorized people Only human blood or artificial control
73. rmal quantity of debris or small cells P2 P to CP2 Presence of schizocytes P3 CP3 to CP3 2 Presence of microcytes 8 5 5 Machine Flags INS T Means that the working temperature is lower than 17 C or higher than 33 C and the result could be affected INS P Means that the vacuum counting is out of range if the flag appears at each cycle please contact your Orph e s representative Page 62 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 8 TECHNOLOGY 8 6 HYDRAULIC 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 8 6 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 The o ring of the needle included in the cleaning system can also be removed without tool see section 9 3 2 The maintenance of these parts is very easy to perform 8 6 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 reage
74. roblasts on smear RBC Cold Agglutinin 3 red cell clumping on smear Severe Microcytosis C Fragmented RBC Leukocytosis gt 100 000 uL Elevation of WBC HGB Leukocytosis gt 100 000 L Elevation of WBC Lipemia TMCHC milky appearance of plasma Abnormal Protein TMCHC Lysed Hgb WBC sample turns cloudy HCT Cold Agglutinin TMCV LHCT red cell clumping on smear Leukocytosis gt 100 000 uL Elevation of WBC Abnormal Red Cell Fragility Spherocytosis vMCV spherocytes on smear PLT Pseudothrombocytopenia Platelet Satellitism on smear Platelet Aggregation Platelet Aggregates on smear Increased Microcytosis Platelets Instrument count is affected an increase in the result Instrument count is affected a decrease in the result Instrument count is affected by either an increase or decrease in the result which is sample dependent MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 39 84 5 SAMPLE ANALYSIS REF M18C UM EN 012 5 SAMPLE ANALYSIS 5 1 VERIFICATIONS BEFORE STARTING Before starting MYTHIC 18 we recommend to check the reagent levels in each bottle and the level of the waste container Please also check the paper quantity in the printer 5 2 START UP Press ON OFF button on the printer to start Press ON OFF button on the Mythic TION IN EM UPDATE EXCEED 3 Th
75. ry date labeled on the bottle Precautions Can cause skin and eyes irritation Wear a smock gloves and glasses during manipulation First emergency care Inhalation Breathe fresh air Eyes Abundantly rinse during 15 mn Skin Abundantly rinse Ingestion Vomit If any doubt call an emergency center 4 3 2 Lysis reagent ORPHEE code number HM18 002 1 Shelf life once opened 60 days Application Lytic reagent is used to lyse the red blood cells the leukocyte differentiation and the cyanmethemoglobin complex formation used during the measurement performed on the MYTHIC 18 see section 8 Active components 3 50 surfactant 0 03 Potassium cyanide Quaternary ammonium salt Description Clear aqueous solution with a light almond odor MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 37 84 4 SPECIFICATIONS REF M8C UM EN 012 Storage At room temperature until expiry date labeled on the bottle Precautions Can cause skin and eyes irritation Wear a smock gloves and glasses during manipulation First emergency care Inhalation Breathe fresh air Eyes Abundantly rinse during 15 mn Skin Abundantly rinse Ingestion Vomit If any doubt call an emergency center 4 3 3 Cleaning solution ORPHEE code number 18 001 1 Shelf life once opened 60 days Application The cleaning solution is used to carry out the cleaning of the measurement system and hydraulic circuit see sectio
76. s to validate or to unselect a result TOOLS To print send delete or save ina USB key a result press KH Press to open the Levey Jennings graph screen MYTHIC 18 REF M18C UM EN 012 6 QUALITY CONTROL 6 2 3 Levey J ennings graph PREVIOUS SCREEN This menu enables to display the Levey Jennings graph for each quality control run The column on the left shows each parameter with the target values and the limits The value under the name of the parameter is the value where the cursor is located on the graph The keys lt gt enable to display the other results The cursor tf 1 2_ located under the graph enables to display all the registered results number of the result give the date and the time of the displayed result 6 2 4 Restore Lot RESTORE This menu enables to restore all the information results and targets for the file selected from the USB key to the internal memory PREVIOUS SCREEN Press YES if you are sure to load the selected file a EE ozerase N EA 458JFD L CBR488 H 789 N RBC128 L a ZWR4S6 H BHRFD N CJJT288 L the information of the selected file will be overwrite by the one coming from the USB key E 0263789 H 811 KKDF88 N YOU AR OING TO MBK785 L BUERURTTE THe 0 _ QC LOT DO YOU WANT TO
77. sition at the maximum course HAZARDOUS MOVING PARTS BEWARE TO STAY AWAY FROM THESE PARTS WHEN THE MACHINE IS SWITCH ON 1 2 INSTALLATION CONSTRAINTS 1 2 1 Installation place To ensure that the MYTHIC 18 fulfills its function place the instrument on a table which supports the weight of the instrument printer and reagents around 40 Kg Leave a space of 10 cm in the rear of the instrument to ensure a well ventilated place Avoid a place that can be exposed to direct sunlight 1 2 2 Installation environment Indoor use b Altitude up to 2 000 m c Temperature 18 C to 32 C d Maximum relative humidity 80 for temperatures up to 31 C decreasing linearly to 50 relative humidity at 40 C e MAINS supply voltage fluctuations up to 10 of the nominal voltage f Transient over voltages typically present on the MAINS supply 9 Rated pollution degree IT Page 10 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 1 INSTALLATION Please contact Orph e s representative if you want to use the instrument in special conditions height higher than 2000 m or special power supply conditions 1 3 ELECTRICAL CONNECTIONS All the connectors are in the rear of the MYTHIC 18 CONNECTION SYMBOL 2 USB ports Ethernet connection TCP IP External barcode reader RS232C Printer connection Centronics e Eu Host connection RS232C Power supply cor
78. t to the cell volume Voltage impulse et the electrode terminal Counting Impulse Page 58 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 8 TECHNOLOGY 8 1 2 Hemoglobin measurement The hemoglobin measurement is directly done in the WBC chamber by spectrophotometry at 555 nm Hemoglobin is detected by formation of a chromogen cyanmethemoglobin type for lytic solution with cyanide and oxyhemoglobin for lytic solution without cyanide A measurement of the blank of hemoglobin is done for each analytic cycle and during the start up rinsing step An automatic offset circuit for the LED 555 nm allows to maintain the blank level at the same range It is not necessary to adjust this range with a potentiometer 8 2 LEUCOCYTE ANALYSIS The leukocyte analysis is done by impedancemetry in the WBC counting chamber seven parameters are obtained Parameters Pathologies adjustment section 3 4 4 1 WBC White Blood Cells Leukocytosis WBC gt WBC h Leucopenia WBC WBC b LYM Lymphocytes in percentage Lymphocytosis LYMeLYM h amp or LYM Lymphocytes in value Lymphopenia LYM LYM b amp or MON Monocytes in percentage Monocytosis MON MON h 4 MON Monocytes in value GRA Granulocytes in percentage Granulocytosis GRA gt h amp or GRA Granulocytes in value Ganulopenia GRA lt GRA b amp or The for
79. ted report is a list of all selected results between the two days 5 10 2 View PREVIOUS E RESULT RESULT Keys and allow displaying each result and its GRILLRRD 84 11 10 04 82825 TYPE STRNDRRD ban identification Mu iE HON 4 6 MEER h ER NAN To print send or delete a result press Hey So The printed report is full page with one or two results per 33 0 HCHC 36 2 h RDW 12 3 PLT 5 ES 0 498 To come back to the archive main page press 5 FLAGS FL1FL2FLS FRIFRe To come back to the Main Menu press STARTUP FAILED QC FAILED PREVIOUS SELECTION To print or send a result press H ALL NB PAGES 538 E q It is possible to print or send ALL All results Press Selected results Select the first and the last results amp SEQ sFROM 8526 0 To delete a result come back to the list display SEQ sFROM FLRGS FL1F STARTUP FR PREVIOUS SEQ NEXT RESULT 9529 RESULT 2215 FRIFR2 TILED QC FAILED This message appears when you exit the result screens and it could stay up to 3 to enable the update of all the files Page 48 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 5 SAMPLE ANALYSIS 5 11 STAND BY AND SHUT DOWN START UP SHUT DOUN CALIBRATION QUALITY CONTROL RESULTS
80. ulation following the formula MCV HCT 10 RBC The RBC distribution curve analysis allows the measurement of RDW RDW is an expression of the standard deviation compared to MCV This parameter evaluates the RBC anisocytosis RDW SD MCV Wintrobe constant calculation The Mean Corpuscular Hemoglobin MCH calculation is made from HGB and RBC by the formula below HGB 10 RBC The Mean Corpuscular Hemoglobin Concentration MCHC is made from HGB and HCT by the formula below MCHC HGB 100 HCT Page 60 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 8 TECHNOLOGY 8 4 ANALYSIS OF PLATELETS Platelet analysis is made by impedancemetry in the RBC counting chamber at the same time with red blood cells Four parameters are obtained Parameters Pathologies adjustment section 3 4 4 1 PLT Platelets Thrombopenia PLT PLT b Thrombocytosis PLT gt PLT h MPV Mean Platelet Volume Giant platelets MPV gt MPV h PDW Platelet Distribution Width PCT Thrombocrit The analysis of the platelet distribution curve allows measuring the Mean Platelet Volume MPV and the Platelet Distribution Width PDW Thrombocrit PCT is made from PLT and MPV by formula below PCT PLT MPV 10000 8 5 ALARMS MYTHIC 18 manage 17 different alarms These alarms allow the user to be alerted if there is a mistake which can affect the quality of the results All
81. ution Width Thrombocyte parameters PLT MPV PDW PCT Platelet Mean Platelet Volume Platelet Distribution Width Thrombocrit For Investigation Use only in the United States of America Page 16 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 2 GENERAL OVERVIEW 2 2 OVERVIEW MYTHIC 18 consist of 8 main parts 1 Display Keyboard Dilution hydraulic part Mono electronic board Reagent tray Connection External power supply block Printer Barcode reader option ON Oo Oe MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 17 84 2 GENERAL OVERVIEW REF M18C UM EN 012 2 3 MAIN PART DESCRIPTION 2 3 1 Display Keyboard Stand By and ON OFF button Numeric keyboard Delete DEL Exit ESCAPE m Lem Enter ENTER Cycle in process Led Touch screen LCD display 380 240 gt 18 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 2 GENERAL OVERVIEW Main Menu description Start Up rinsing and Blank control Back to previous screen PRELTOUS Print Send Select Direct access to Options main menu Date and Time System status section 3 2 SCREEN ae MENU HAT Cleaning and stand mode STRRT SHUT CALIBRATION QUALITY CONTROL RESULTS SET UP SERVICE OPERATOR LOG OUT REAG
82. ve the tubing fixed on the RBC counting head located on the right side of the counting module MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 75 84 9 SERVICE REF M8C UM EN 012 Remove the tubing fixed on the plastic fitting located under the stainless tube from WBC counting block Remove all connectors The counting bath module can now be handled to carry out the desired operations of replacement REASSEMBLY PROCEDURE To reassemble the unit carry out the various operations in the opposite direction Page 76 84 Copyright Orph e SA All Rights Reserved MYTHIC 18 REF M18C UM EN 012 9 SERVICE 9 4 4 Baths o ring replacement Wear rubber gloves and wash hands with a disinfectant after completion of work Before performing the operation drain the baths and dismantle the counting bath block see section 9 4 3 Replace the o ring and or the complete bath block REASSEMBLY PROCEDURE To reassemble the unit carry out the various operations in the opposite direction Place the seal on the counting bath gently not to wound it 9 4 5 Aperture block replacement VN Wear rubber gloves and wash hands with a disinfectant after completion of work Before performing the operation drain the baths and dismantle the counting bath block see section 9 4 3 Remove the tubing from the blocks t
83. xe II Dispositivo per test autodiagnostico non elencato nell allegato II Device for self testing not listed in Annex II X Sonstiges Produkt Autre dispositif Altro dispostivo Other device allen Anforderungen der Richtlinie ber In vitro Diagnostika 98 79 EG entspricht die anwendbar sind remplit toutes les exigences de la directive relative aux dispositifs m dicaux de diagnostic in vitro 98 79 CE qui le concernent soddisfa tutte le disposizioni della direttiva relativa ai dispositivi medico diagnostici in vitro 98 79 CE che lo riguardano meets all the provisions of the directive on in vitro diagnostic medical devices 98 79 EC which apply to it MYTHIC 18 Copyright Orph e SA All Rights Reserved Page 5 84 Angewandte Gemeinsame Technische Spezifikationen harmonisierte Normen nationale Normen oder andere normative Dokumente Sp cifications techniques communes normes harmonis es normes nationales et autres documents normatifs appliqu s Specifiche tecniche comuni norme armonizzate o nazionali applicate altri documenti normativi applicati Applied common technical specifications harmonised standards national standards or other normative documents Konformitatsbewertungsverfahren Proc dure d valuation de la conformit Procedimentodi valutazionedellaconformita Conformity assessment procedure Konformitatsbewertungsstelle falls beigezogen Organe respons l valuat de la conformit si c

Orphee Mythic 18 Hematology Analyzer

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