Home

Orphee Mythic 22-CT Hematology Analyzer

1. 0 0 0 2 2 02 2 2 3 L USER S IDENTIFICATION tbe ov EL REC Ve Ee PERTENECER nt ven 3 1 1 Start Up 3 1 2 In process 3 2 SYSTEM STATUS 3 3 A RAU min nn ann ner nn ie ne nn an en nee 3 A ADVANCED SE THURS te EAER ERNA 3 4 1 Printer set up 3 4 7 Storage options pi SAB Version telease iic eterna hdi a Ee RE RA REC CURED thc ERR E Qe PEE naines RR KR nt 34 4 SPECIFICATIONS vo b V ale d edu Mt E deu c Ae le 4 1 ANALYTICAL SPECIFICATIONS 4 2 PHYSICAL SPECIFICATIONS nn nn mn tnt mt AS REAGENTS SP CIFICAITONS En relire EDITORI E TE EE E A A E E OE A 4 3 2 Lytic reagent OnlyOne ess m m E eie rel eTA Ke 0n To et DM T D ERE 4 4 ANALYTICAL LIMITATIONS 4 3 1 Recommendations 4 3 1 Interferences MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 9 102 REF M22CT UM EN 003 D SAMPLE ANALYSIS o a ede d ee ME Sy cheeses bid 5 1 VERIFICATIONS BEFORE STARTING gas DZ START scat de bee T dee RR e a e d a en et eae ed RE i e 9 3 REAGENT REPLACEMENT M DA START UP RINSING sement tr en ein nt nt nr nt nr nr rte 5 5 PREPARATIONS BEFORE ANALYSIS 5 5 1 An
2. MAINTENANCE TO BE DONE BY THE USER yellow boxes Reagents level control see section 5 3 Start up see section 5 2 Automatic Cleaning The cleaning is automatically performed by the MYTHIC 22 CT 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 22 CT in case of analyzes of pathological samples or if there are too many flags and too often Concentrated cleaning see the following section 9 1 2 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 In line filter cleaning see section 9 1 4 Needle o ring replacement see section 9 4 2 Pump drying The pump is checked and cleaned every year Page 82 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 95 9 1 2 Concentrate cleaning This cleaning is necessary once a week to clean the WBC bath or when MYTHIC 22 CT is in permanent rejection for one measured parameter or permanent clog flag see section 8 1 5 Prepare a Sodium Hypochlorite solution at 12 in chloride diluted 4 times with distilled water if sodium hypochlorite is concentrated at 48 in chloride or three time with 36 MENU Return to the main menu by pressing EI
3. PR DATE amp TIME ME hh mn DRTE LRNGURGE ISH PRINTER Select the printer or no printing PRPER SIZE LETTER Select the paper size per result PAPER SIZE 11 LETTER START DAY SID Two SID are available Start day SID enables START DAY SID to select the first SID for each new day CURRENT SID 1 CURRENT SID If you want to select a new SID number ADVANCED Esc PRINTER 3 UPDATE ADVANCED Biologist reserved for complete settings See section 3 4 Once modifications are done press either veut to valid or lt to exit keeping the previous setting TOOLS Press KH to print save or load from an USB key all the set up To load new printers drivers plug the USB key then press on PRINTER 9 UPDATE in the previous screen ous PERS cud ES PRINTER PORT Select the printer and his connection mode LOAD Then press Press Aes then the driver is loaded in the MYTHIC 22CT This prompt appears to confirm the Driver update 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 22 CT Copyright Orph e SA All Rights Reserved Page 27 102 3 INSTRUMENT SET UP REF MZ2CT UN EN OO3 3 4 ADVANCED SET UP Any modifications can af
4. MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 65 102 6 QUALITY CONTROL nEF M22CT UM EN O03_ 6 3 REPEATABILITY To run repeatability press first mE The key meun or __cLOse TUBE allows to access to the repeatability display This screen allows to carry out a test of repeatability on all the parameters measured by the MYTHIC 22 CT To run repeatability analysis from a closed tube o Put the sample in the tube holder Press Repeat this operation as long as needed The results are displayed in line run after each run The statistic calculation is shown at the bottom of the display and are automatically done after each run Repeat the operation as many times as desired maximum 20 runs It is mandatory to change for a new cap after a Maximum of 10 piercing WEE REC HOT PLT rici 0 0 2 001 a al a a 3 01 6 001 a a 3 81 al a 5 07 0 07 0 0 0 01 aol a The column _ lt EL allows to validate or to unselect a result Page 66 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT REF M22CT UM EN 003 6 QUALITY CONTROL CLOSE amp RUN mmm 2 0 4 00 a a al a 8 81 6 00 6 8 1 a a al a 8 81 o ala ala al a al TOOLS The key 8 allows to do the f
5. 2 oo OCOC CCOGUO EC ELIO NO NNVOWLLD Example of a normal result analysis in CBC mode 68 08 00 00 TOOLS Press to reprint or to resend the result To print the result press To send the result press Ls To close the window press MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 55 102 5 SAMPLE ANALYSIS REF M22CT UMVEN O03_ 5 8 PRINTING Once the analysis is finished the MYTHIC 22 CT prints a result report To modify the printing presentation or to disconnect the printer see section 3 4 1 To load a new printer driver see section 3 3 5 8 1 Model report A4 external printer EPSON LX 300 model One result per page DIF mode CBC mode ORPHEE MEDICAL DRPHEE MEDICRL Presentation Results MYTHIC 22 Presentation Results MYTHIC 22 Name Patient Id N Comments Sample Id 80017 00018 STANDARD STANDARD Operator 10 SAS Date 14 12 2005 11 25 56 Seat 00032 Operator ID SAS Date 14 12 2005 11 2 Seat 00033 Result Flags Unit Normal Limits Result Flags Unit Normal Limits 5 7 10 3 1 WBC 5 8 18 871 4 0 12 0 Ih P 40 2 11 3 h L RBC 107671 aa 6 20 HGB g dl HCT A MCU Ji MCH HY MCHC g dl RDW PLT 10 3 1 187671 MPU n 3 A g dl PCT z FN Z A n 3 i pa AGS g dl FLAGS PLT L MPU PCT
6. 2 000 N2v aaa UM MON LNLX 866 LNLY 000 NEU a EOS 000 LMNY BAS 6 LNEX 9890 LNEY 000 Ni N2 6 Easy 966 ALL H ALL L 6 LMX NH L 6 NH H 666 RNEY 000 NL L NL H NMY RL L A jJ Bx1 666 1 Bx2 000 BY2 aaa POP 000 BYS aaa WBC 0 8 Ex4 900 BY4 LYNZ 8 0 LYM 6 6 MONZ NEUZ 05 BAS esc resr init ver Copyright Orph e SA All Rights Reserved Page 31 102 3 INSTRUMENT SET UP REF M22CT UM EN O03 _ S DIFF THRESHOLDS RAW DATA EE N1Y aaa WBC 7 Hat 900 666 1 a Iz 1 NH L 8 NH H NL L NLL 666 NLH aaa NL H RL L RLL 666 RLR 900 RL R HL L 8 HLL 886 HLH 000 HL H a FLAGS LEVEL TYPE STANDARD a TE Page 32 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT Threshold modifications can affect the quality of the results or can affect the alarm detection area We recommend to modify these values only after an Orph e s training INIT DEF Press DEF 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 PLT and differential
7. FLAGS MONOCYTOSIS NEUTROPENIA Comments Comments Page 56 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT REF M22CT UM EN 003 5 SAMPLE ANALYSIS Two results per page DIF mode CBC mode ORPHEE MEDICAL Presentation Results MYTHIC 22 ORPHEE MEDICAL Presentation Results MYTHIC 22 Name Comments Name Patient 14 Comments Sample Id Type 90818 STANDARD WBC Lyn MON 05 BRSZ RBC HGB HCT mcu MCH MCHC RDW PLT MPU PCT FLAGS MYTHIC 22 CT Operator ID Result 5 7 480 2 11 3 42 8 5 8 8 7 5 12 15 3 46 4 98 6 30 0 33 1 13 2 308 8 1 9 248 12 8 5 8 2 Model report Thermal printer SAS Patient Id Sample Id 90017 Type STANDARD Date 14 12 2005 11 25 56 Seat 00032 Flags Unit Normal Limits 18 3 1 4 8 12 0 25 0 50 0 h 2 8 10 0 L 50 0 80 0 8 8 5 0 8 8 2 0 187671 4 08 7 6 20 gdl 11 0 17 0 A 35 0 55 8 n 3 80 8 100 0 pg 26 0 34 0 g dl 31 0 7 35 5 z 10 0 16 0 18 1 158 400 m3 7 0 11 8 2 9 209 4 500 z 19 8 18 0 MONOCYTOSIS NEUTROPENIA Operator ID SAS Date Result Flags Unit Normal limits WBC 5 8 104371 4 8 12 8 REC 5 14 10 6 1 4 00 6 20 HGB 15 4 gdl 11 0 17 0 HCT 46 3 35 0 55 0 MCU 90 0 n 8 80 0 180 0 MCH 29 9 pg 26 0 34 8 MCHC 33 2 91 0 35 5 RDW 13 2 18 0
8. To validate the new values press VALID key in the next page see below Once modifications are done press to validate or Esc to exit without any modification to return to the parameter setting of the standard MYTHIC 22 CT REF M22CT UM EN 003 3 INSTRUMENT SET UP Example of reference values from LABORATOIRE D HEMATOLOGIE DU C H U D ANGERS FRANCE First week BIOS te 3 to 6 years 92028 Adult months 3 years 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 4 0 to 10 0 Neutrophils 10 pL 6 0 to 26 0 1 5 to 8 5 15108 5 15108 5 1 8 to 8 0 1 8 to 7 5 Eosinophils 10 pL 0 2 to 0 85 0 2 to 1 2 0 05 to 0 7 0 02 to 0 65 0 to 06 0 04 to 0 8 Basophils 10 uL 0 to 0 64 O to 0 2 O to 0 2 O to 0 2 O to 0 2 O to 0 2 Lymphocytes 10 pL 2 0 to 11 0 2 0 to 11 0 4 0 to 10 5 2 0 to 8 0 1 5 to 6 5 1 0 to 4 5 Monocytes 10 pL 0 4 to 3 1 0 05 to1 1 0100 8 0100 8 0100 8 0 2 to 10 6 12 M 4 5 to 58 RBC 10 uL 10 L 5 0 to 6 0 3 8 to 4 8 3 6 to 5 2 44 to 5 3 4 0 to 5 4 38 954 H 13 5 to 17 5 HGB g dL 14 5 to 22 5 10 to 16 105 to 13 5 105 to 13 5 11 5 to 14 5 F 125t0155 e 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 or 27 MCHC g dL 32 to 36 32 to 36 32 t
9. ur SID STANDARD Example of an abnormal result analysis in DIF mode with flags located at rt the right of the results and in the flag box under the result comzzrz DOMO lt D Qno It is mandatory to read the section 8 5 to understand the flags meaning gt pip cose un SID STANDARD DEBRIS OR SHELL CELLS Press on the flags zone to open the flags window In regard of the different flags found by the MYTHIC 22CT the upper OB ERAS ay aie part propose list of the cells to check on the smear In any case this proposal is a commitment it is mandatory to read the section 8 5 to understand the flags meaning AGS L1L2 S_TINS_P 10 PID 510 TYPE STANDARD LS RiR2 INS The lower part describe the machine problem see section 8 5 2 Page 54 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT PREVIOUS TOOLS MENU ID 28 07 06 48AM EID REPEATABILITY TYPE STANDARD e Press the scattergram to access to a zoomed view LYNZ 32 DIF NEU EDS BAS DSSS IID Cm E TOOLS TEN MENU 14 12 11 27 TYPE STANDARD WND 1 WADON 4 ee
10. 1085 From the main menu press a to reach the logs display MYTHIC 22 CT manage simplified log allowing to save and display all the events done for the following actions BIO Login with the Biologist password Login with the service Technician password STC Login with the Super service Technician password 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 ITE ACN Autocleann cycle Ni Bleach cycle CAL Calibration Quality control DEL Results deleted in Archive Each column is identified by a number recall at the right bottom of the screen In the bottom of the screen is displayed the date PAIE and under it the number of analysis MUM run during this X X X X X m D zd DO 00 iO Imi r m d TOOLS SELECTION NB PAGES 8 To print or save the log report press Select AY to print or save the logs of the of pages indicated the screen To print or save the logs of one or more days select DAY then enter the day reference number Press se to save the logs on the USB thumb drive DAY MYTHIC 22 CT can save more tha
11. Re start the Mythic Nothing Re start the Mythic Perform pistons greasing Perform a control cycle Check your analyzer configuration Check your analyzer configuration Switch on the printer or invalidate the printings Switch on the printer or invalidate the printings Switch on the printer or invalidate the printings Delete data on the selected directory Modify the value Select the right driver compatible with the Mythic 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 Re start the Mythic Re start the Mythic Press OK The instrument is ready to work You have to be Logged with the good access code Perform a start up cycle Perform a new start up cycle Update the SVM software Re start the SVM This MYTHIC cannot be connected to the SVM Re enter the file or confirm it manual connection on the SVM Westgard alarm XB alarm Call an Orph e representative System is resetting after the version released Re start the Mythic Re start the Mythic Page 98 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT REF M22CT UM EN 003 9 SERVICE MESSAGE ACTION SYSTEM INTERNAL TIME OUT TOO MANY FILES OPENED VERSION RELEASE FAILED THE CHOSEN RELEASE IS NOT COMPATIBLE WITH
12. Then press Press to start the cycle drain the counting chamber MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 83 102 9 SERVICE REF M22CT UM EN 003 Open the door on the right side see section 1 1 3 Put 3 ml of sodium hypochlorite solution in each counting chamber Press the button in the window located in the screen center MYTHIC 22 CT performs a maintenance cycle of the apertures and the flow cell follow with a stand by mode during 2 min After 2 min MYTHIC 22 CT rinses all of the elements Operator can perform an analytic cycle Wear rubber gloves and wash hands with a disinfectant after completion of work To have access to the hydraulic cycle press ee 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 PRENIO TOOLS MENU CER Press Pos to put the piston of the syringe module in the greasing position Page 84 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 95 Wear rubber gloves and wash hands with a disinfectant after completion of work Open the door on the right side see section 1 1 3 Put a small nut of grease on a finger Put a
13. This module two patents pending enables to draw the sample to distribute the reagents to drain the baths to do the vacuum necessary for counting to push the waste to the waste container to push the WBC sample and the diluent sheath in the flow cell 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 8 6 4 Optical manifold This manifold allows to drive the different reagent toward the counting bath module or toward the optical bench It maintain seven commutation valves MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 79 102 8 TECHNOLOGY REF M22CT UW EN 003 8 6 5 Optical bench This very important part two pending patents allows to measure the leucocytes sub population It is made of three parts an illumination module which contain the semi conductor light source a beam adjustment glass smear and lens a flow cell made in injected plastic in which the sample and the passive sheath flow away and the detection module which contains lens a beam separation glass smear photodiodes and the amplifier boards for the two measurement axes 8 8 SOFTWARE 8 8 1 Windows Common keys uM 2 allows
14. Tubing 61 CT 240 100 Tubing 62 CT 200 100 Tubing 63 CT 30 Tubing 64 CT 70 Tubing 65 CT 60 MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 1 9 SERVICE REF M22CT UM EN 003 Al ET x e Den al Page 102 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT
15. 16 8 PLT 301 1a 37l 159 408 MPU 8 1 n 3 7 6 11 0 PCT 9 243 8 208 0 590 PDW 12 7 10 0 18 8 SEIKO DPU 414 model DIF mode ORPHEE MEDICAL Presentation Results MYTHIC 22 Name 14 12 2005 Patient Id 11 25 56 Sample Id 00017 Type STANDARD Seat 90032 Operator ID SAS WBC 5 7 182371 4 87 12 6 LYNZ 40 2 E 25 0 50 0 MOI 11 3 h 7 2 0 10 0 NEUZ 42 8 L 58 80 80 0 EOS 5 8 z 8 0 5 0 BASZ 9 7 z 0 07 2 0 RBC 5 12 187671 4 00 6 20 HGB 15 3 g dl 11 0 17 0 HCT 46 4 85 0 55 0 MCU 98 6 n 3 80 0 100 0 MCH 30 0 pa 26 0 34 0 MCHC 33 1 gdl 31 0 35 5 RDW 13 2 z 19 9 16 0 PLT 308 187371 150 400 MPU 8 1 n 3 7 0 11 0 PCT 248 4 200 4 500 12 8 x 18 0 18 0 FLAGS MONOCYTOSIS NEUTROPENIA CBC mode 14 12 2005 11 27 39 ORPHEE MEDICAL Presentation Results MYTHIC 22 Name 14 12 2005 Patient Id 11 27 30 Sample Id 00018 Type STANDARD Seat 00033 Operator ID SAS WBC 65 8 1893 1 4 87 12 8 5 14 10 6 1 4 087 6 20 HGB 15 4 gdl 11 0 17 8 46 3 35 0 55 0 MCU 92 0 n 8 89 0 180 0 29 9 pa 26 0 34 0 MCHC 33 2 gdl 31 0 35 5 RDW 13 2 10 0 16 8 PLT 301 1873 1 1587 400 MPU 8 1 n 8 7 0 11 8 PCT 9 243 9 298 6 500 12 7 18 0 18 8 Copyright Orph e SA All Rights Reserved Seat 00033 Page 57 102 5 SAMPLE ANALYSIS REF M22CT UMVEN O03_ 5 9 LOGS
16. 22 CT Copyright Orph e SA All Rights Reserved Page 25 102 _3 INSTRUMENT SET UP REF M22CT UMVEN O03_ If this window appears it means that several results in memory have not been sent RESULTS HAVE TO before the MYTHIC 22 was switched off Oo OU WANT TO SEND Press YES to send them immediately or press LATER to wait 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 NOT SAVED ONTO THE EXTERNAL STORAGE DEVICE to change the archive mode BO 900 WANT THESE FILES TO BE MOUED ONTO IT P SOME RESULTS HAVE BEEN 3 2 SYSTEM STATUS IS MERE M TOOLS Ez Press on the date and hour to have access to the system status window 10 OPERATOR ACCESS gt Different system status information are displayed SOFT UERSION LORDER RIEN To change the screen luminosity press L N or H Dios EN eur To return to the MAIN MENU press RUN SAMPLE Page 26 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 3 INSTRUMENT SET UP 3 3 SET UP From the MAIN MENU press on mn nil This menu is available for all users The DATE amp TIME window enables to modify the time and the date To select the language of the Mythic menu choose the right one in the LRNGURGE ENGLISH Language combo box PRINTER LX 398
17. ALL Board Check the hardware connection on FSC Board Check if your temperature fan is running Call an Orph e representative Check your enclosure sensor Call an Orph e representative Check your reagent sensor Re start the Mythic Wait for the system to reach its temperature Message reserved to the service people Message reserved to the service people MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 97 102 9 SERVICE REF M22CT UM EN 003 MESSAGE ACTION HOLDER CLOSE DOOR TO ADJUST ID AND OR PID MANDATORY CHECK SETUP SID ALWAYS MANDATORY PRINTER DRIVER UPDATE FAILED THE CHOSEN DRIVER IS NOT COMPATIBLE WITH THE MYTHIC 22 SYSTEM SYSTEM DOWNLOADING NEW VERSION PLEASE SYSTEM FATAL ERROR Message reserved to the service people Check if something prevent the door closing Check if something prevent the door opening Put the tube holder Check if something prevent the door opening Enter an ID and or PID and SID Switch on the printer or invalidate the printings Re start the Mythic Re start the Mythic Re start the Mythic Wait before performing a cycle If persisting re start the Mythic Select another lot Replace the bottle and perform a prime Lysis Perform an initialization or a control cycle Perform an initialization or a control cycle Perform an initialization or a control cycle Re start the Mythic Nothing
18. AUTOCLEAN and its frequency in number of analysis CLEAN FREQUENCY Run Nb o The setting of the automatic wake up M VALID WAKE and its daily time WAKE UP TIME t4 e0 Reagent checking enables the reagent control see section 1 5 2 Pressure Checking is accessible for technician only BIOLOGIST PASSWORD 125 enables to modify the biologist password M VALID AUTOCLEAN CLEAN FREQUENCY Run Nb 3a VALID UP WAKE UP TIME DATE FORMAT j v AM PM MODE BIOLOGIST PASSWORD REAGENT CHECKING v PRESSURE CHECKING DATE FORMAT enables to select the date format Once modifications are done press _vau to validate or without any modification 3 4 7 Storage options PREVIOUS MYTHIC 22 save more than the last 1500 patients with results alarms distribution curves in the internal memory and until a maximum of 60 000 oe results in a memory stick USB key with capacity from 512 Mb to 2 Gb a maximum can be used Dre eu Because the technology of the USB key are very different some of them could not work For more information contact your Orph e s representative 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 Choose REAL TIME RUNS SAVE to directly save sample ru
19. BRCKUP SYST 82786 12 33 088 BRCKUP SYST 83786 20 51 889 BRCKUP SYST 04706 64 09 090 BRCKUP SYST 85786 12 27 891 BACKUP SVST 86786 20 45 892 BACKUP SYST 87786 04 03 893 HARDWARE SV 08706 12 21 894 HARDWARE SV PEE 9706 20 39 895 HARDWARE SV 6 64 57 096 HARDWARE SV Y HARDWARE SYSTEM ERROR ET 1 Tans seem SELECTION PAGES 5 ERR FROM 55706 PM TOGO INTERN COU 86786 68 45PM 061 INTERN COU 87786 64 03AM 862 RUNNING AUT 08796 12 21PM 863 DILUENT ALM 09796 08 39PM 064 LYSE ALMOST 212 26 04 57AM 965 CLEANER ALM Y 4 CLEANER ALMOST EMPTY Page 100 102 From the MAIN MENU press Then press This screen allows to visualize the date and time 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 Select to print the errors of the number of pages indicated on the screen 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 NP then enter the error reference number Copyright Orph e SA All Rights Reserved MYTHIC 22 CT REF M22CT UM EN 003 9 SERVICE 9 8 HYDRAULIC DIAGRAM The length and inner diame
20. Complies Electromagnetic environment guidance The MYTHIC 22 CT is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Guidance and manufacturer s declaration Electromagnetic immunit The MYTHIC 22 CT is intended for use in the electromagnetic environment specified below The customer or the user of the MYTHIC 22 CT should assure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 test level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT gt 95 dip UT for 5 sec 3 A m Compliance level Complies Complies Complies Complies Complies Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality sh
21. Plan Les Ouates Mythic 22 CT Ref M22CT 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 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 L Produkt zur Eigenanwendung das nicht in Anhang II genannt ist Dispositif destin l autodiagnostic non list dans l annexe 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
22. See section 8 5 The WBC flags appear when the limit AND limit are reached The RBC and PLT flags appear when the limit OR limit are reached Once modifications are done press to validate or to exit without any modification INIT DEF Press type to return to the parameter setting of 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 Once modifications are done press _vau to validate or Esc without any modification To exit _REF M22CT UM EN 003 3 INSTRUMENT SET UP 3 4 5 Calibration factor CALIBRATION FACTORS To accede to this menu press in the ADVANCED SET UP MENU see section 3 4 a a In this menu the user can modify the calibration factors without any calibration with calibration blood AM letter appears on the right of the date of calibration in case of modification in the Calibration Menu 1 66 py 7 005 1 06060 The modification of any of these factors without running a calibration blood could affect the quality of the result 3 4 6 Other Setting ae In DELAY box the user can modify Eu 02 Time in minutes to start the automatic shut down DELAY ms o Time in minutes to buildup the needle ee The setting of the automatic cleaning M VALID
23. THE MYTHIC 22 SYSTEM VERSION RELEASE FAILED THE CHOSEN RELEASE IS NOT COMPATIBLE WITH THE MYTHIC 22 SYSTEM WASTE ALMOST FULL Re start the Mythic Room temperature out of range lt 18 or gt 34 C Replace the bottle and perform a prime Cleaner Replace the container and perform a prime Diluent Replace the bottle and perform a prime Lysis The USB thumdrive as an incompatible tree structure for the analyzer try another one The USB thumdrive as an incompatible tree structure for the analyzer try another one The USB thumdrive as an incompatible tree structure for the analyzer try another one The USB thumdrive as an incompatible tree structure for the analyzer try another one No memory available in USB for storage You have to delete some data to work Connect an USB thumdrive The USB thumdrive as an incompatible tree structure for the analyzer try another one The USB thumdrive as an incompatible tree structure for the analyzer try another one The USB thumdrive as an incompatible tree structure for the analyzer try another one The USB thumdrive as an incompatible tree structure for the analyzer try another one The USB thumdrive as an incompatible tree structure for the analyzer try another one Select the correct version Replace the waste container The USB thumdrive as an incompatible tree structure for the analyzer try another one The USB thumdriv
24. 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 The in line filter allows to eliminate the small piece of rubber cap which could be created in case of multiple sampling of the same sample or if the rubber cap quality is poor Wear rubber gloves and wash hands with a disinfectant after completion of work Clean or exchange the filter following the maintenance table see section 9 1 1 or when the message Pressure default appear see section 9 5 2 MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 85 102 9 SERVICE REF M22CT UM EN 003 This type of filter is disposable and must be throw away when it is blocked Be aware to not reuse inline filter upside down It could inject small parts in to valves and generate malfunction Open this type of filter older then clean the filter cartridge with a disinfectant and remove the pieces of rubber Reassemble the filter cartridge and the filter holder Take attention to well closed the filter holder To have access to the hydraulic cycle press ae from the MAIN MENU then press REESE drain the counting baths the flow cell and the waste syringes press To fill the counting
25. WBC 10 mm 127 0 997 52 0 996 LYM 113 0 989 52 0 974 MON 113 0 935 52 0 974 NEU 113 0 988 52 0 963 EOS 113 0 950 52 0 933 BAS 113 0 187 50 0 093 RBC 10 mm 127 0 991 52 0 994 HGB g dL 127 0 997 52 0 995 HCT 127 0 984 52 0 990 MCV fL 127 0 947 52 0 968 RDW 127 0 746 52 0 903 127 0 963 52 0 980 MCHC g dL 127 0 151 52 0 175 PLT 103 mm 127 0 990 52 0 978 MPV fL 127 0 890 52 0 924 2x Xy Calculated method n 2 Zx n zy Mode to mode closed tube and other vial acceptable differences PARAMETERS MEAN DIFFERENCE whichever is greater WBC 10 mm 0 5 or 5 RBC 105 mm 0 3 or 2 HGB g dl 0 5 or 2 PLT 105 mm 40 or 7 Page 36 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 4 SPECIFICATIONS 4 2 PHYSICAL SPECIFICATIONS General Ambient temperature from 18 to 34 C Relative Humidity 80 maximum at 32 C Storage temperature 10 to 50 C room temperature during 24 hours before switching it on If the MYTHIC 22 CT has been stored at a temperature less than 10 C it must stay at INSTRUMENT Dimensions Height 350 mm approx Width 250 mm approx Depth 340 mm approx Weight 13kg approx Power supply Input 24V 5A DC Electric consumption During cycle 75 VA 30 10 Stand By 20 VA 30 10 Maximum 110 VA 30 10 Display
26. levels are adjustable in the 20 types of blood see section 3 4 4 Number of cells in zone 1 Noise 1 Presence of platelet aggregate debris or resistant RBC 2 Noise 2 Presence of platelet aggregate erythroblast or small lymphocytes IC Presence of Immature Cells from the mono or polynucleated cells line Number of cells located of each side of the threshold RL Right Lymphocytes Presence of atypical lymphocytes or basophiles HL High Lymphocytes Presence of basophiles small Neutrophils without granulations or few segmented band cells NL Neutrophils Low Presence of small Neutrophils without granulations or few segmented band cells or hyper basophil Monocytes NH Neutrophils High Presence of giant Neutrophils hyper segmented Neutrophils eosinophils with few granulations or damaged eosinophils The WBC flags appear when the limit AND limit are reached much more than 30 times These flags may appear if the blood was not store good conditions if it was sampled too MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 77 102 8 TECHNOLOGY REF M22CT UW EN 003 DIF parameters display rules If one or more DIF parameters LYC MON NEU EOS or BAS are following with a star XXX the sample must be checked on smear Basophile result must be checked on smear if it is following by a star XXX WBC CURVE FLAGS This curve is done by the WBC channel
27. representative authorization 1 3 1 Power supply block MYTHIC 22 CT 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 22 CT and if possible in an upper position to avoid the contact with any liquid To disconnect electrically the MYTHIC 22 CT remove the power supply plug from the main circuit In case of replacement of the main power wire supplied with the MYTHIC 22 CT the new one must comply with the local regulation 3X1 5mm cable and 250V 10 plug The MYTHIC 22 CT has been certified with the power supply provided with the machine If another power supply is used with the instrument Orph e or its representative will not apply any warranty on this power supply and on the instrument Please contact Orph e or its local representative before to use such material 1 4 PRINTER CONNECTION Connect the printer cable in conformity with the printer user s manual Use the parallel rear plug of the MYTHIC 22 or the USB plug lt to connect the printer cable Select the printer driver section 3 3 Page 14 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 1 INSTALLATION 1 5 CONNECTION CHANGE AND PRIMING REAGENTS
28. strengths should be less than 3V m MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 5 102 REF M22CT UM EN 003 NOTE This equipment has been tested and found to comply with the limits for a Class digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference ina residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet ona circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help The user may find the following booklet prepared by the Federal Communications Commission helpful How to identify and Resolve Radio TV Interference Problems This booklet is available from the U S Government Printing Office Washington D C 20402 Stoc
29. supply outlet which has an earth connection Preserve a good access to the supply outlet to be able to unplug the MYTHIC 22 CT in emergency case 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 c Do not use the MYTHIC 22 CT if it is not working properly if it has suffered any damage damage to the supply cord or its plug damage caused by dropping the power supply adapter Do not let the power supply adapter or its flexible cord coming in contact with surfaces which are too hot to touch Do not place anything on top of the MYTHIC 22 gt Do not use the MYTHIC 22 CT where aerosol sprays are being used or where oxygen is being administered gt Do not use the MYTHIC 22 CT outside gt Always switch off the MYTHIC 22 CT and disconnect the power adaptor before dismantling any part The MYTHIC 22 CT is an automated hematology analyzer for in vitro diagnostic to be used 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 be used The optimum performances can be only achieved if the cleaning and maintenance procedures are carefully followed Due to the use of this equipment all parts and surfaces of the MYTHIC 22 CT are potentially infective Wearing rubber gloves is highly recommen
30. the white blood cell membrane to keep it in closed native state EOSINOPHILES ALL 0 NEUTROPHILES BASOPHILES ee MONOCYTES FSC LYMPHOCYTES 8 1 3 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 oxy hemoglobin type cyanide free technique 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 number analysis is done by impedancemetry in the WBC counting chamber the other ten parameters are obtained by flow cytometry measurement see section 8 1 2 All the thresholds of the differential are adjustable in the 20 blood types see section 3 4 4 2 Parameters Pathologies adjustment section 3 4 4 1 WBC White Blood Cells Leucocytosis 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 NEU Neutrophils in percentage Neutrophilis NEU gt NEU h amp or NEU Neutrophils in value Neutropenia NEU lt N
31. these information SE to store these information in the USB key Page 68 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT REF M22CT UM EN 003 7 CALIBRATION NOTA If the M letter appears on the right of the date of calibration that means that the last calibration was done by manual modification of the calibration factor see section 3 4 5 Model of print out calibration report CALIBRATION IN PROGRESS SERIAL NUMBER aGaaaaa aaaaaa SOFT UERSION UB 5 PRINTED ON 19 06 2004 15 50 00 BV BILL COEFFICIENTS 1 606 1 606 1 000 1 066 1 606 LOT cs224 CREATED ON 18 12 2063 BV BILL EXPIRY 66 61 2004 WBC RBC HGB PLT TARGETS 9 51 4 25 16 5 46 375 LIMITS 1 8 a 24 0 51 2 1 25 COEF 1 8 1 8 1 61 1 8 1 8 MEANT 6 67 5 081 a a a a o l 8 81 e e 7 1 RUN CALIBRATOR 7 1 1 Calibration blood analysis This screen allows to run analysis on calibration blood to perform the MYTHIC 22 CT calibration To run calibration analysis from a closed vial calibrator blood o Put the control blood in the tube holder CLOSE amp RUN o Press L The results are progressively sent on line in the table Repeat the operation as many times as desired maximum 10 runs Statistical calculations are automatically done after each run The window LoT cszza located between the results and the sta
32. to another character page press or To change the blood type press the combo box us zj and select the type To valid the entry and return to the previous screen press Lm To return to the previous screen without validation press MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 51 102 5 SAMPLE ANALYSIS REF M22CT UMVEN O03_ NOTA The needle will be available as soon as the working temperature is reached about 15 min at 23 C of room temperature ee This prompt means that the temperature setting of the enclosure and or the reagent is not reached yet This prompt means that the temperature setting of the enclosure and or the reagent is reached and that a cycle can be run 5 6 3 Close tube sample run Wear rubber gloves and wash hands with a disinfectant after completion of work f PREVIOUS ay SCREEN TOOLS MENU 12 00AM As soon as the temperature is reached a measurement cycle can be run From the MAIN MENU press _cuose Tube to accede to the closed tube measurement screen The tube holder door open Use the appropriate tube holder NNNNA COOOOCOG e Sate ae OOOO OOOO OOOO e Never use a tube holder with a non dedicated sample tube the needle could be destroyed and the results could be erroneous See the authorized tubes in section 5 5 2 ont lt DOMO lt D O GUII
33. to come back to the previous display This three keys are always present in all screen allows to come back to the MENU display where ever you are the arborescence TOOLS KH depends on the screen it allows to open a window dedicated to perform an action for example to select information to print send save or delete it Windows CYCLE VALVE 1 FAILED NG RESULTS NTER_DRIVER HP HAS BEEN UPLOADED ITO TOAT TOR SU ULLY ROGRE TEM UPDRTE EM UPD SHOULD NOT EXCEED 6 xf MN Means an ERROR WARNING You have to INFORMATION window occurred it is mandatory confirm or not the action to do the action describe in the window describe in the window or in the table section 9 6 8 8 2 Menu tree Page 80 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22cT UM EN O03_ CB TECHNOLOGY USER TREE VIEW VERSION 2 2 0 MYTHIC 22 OT CT TER NSN START UP y Launch Mechanicalaction SHUT DOWN End of day Cycle menus ri diu View Results menu not available Mode chance Te get values Runs for calibration Di 555 J RESULTS 22 ViewChart results YEE CV LEE View by dateand by device nternB memory Mass storage MEW Vieve full screen USE THUME DR
34. 538 22 All results Press NB PAGES 36 for printing Selected results Select the first and the last results SEQ 8 PRINT B i SEND Then press Rm Jy Ded RESULT NOTA the printed report is a list of all selected patients PID FRSE7 05 11 04 510 00420 19 159 05704 95 704 This prompt appears to confirm the storage in the USB key PREVIOUS rc F ET YOU ARE ABOUT TO COPY RESULTS FROM _ INTERNAL MEMORY TO THE USB THUMB MEMORY TO THE Use THUMB If you press YES the selected results will be deleted from the internal memory and stored in the USB key w LO f In co Co Co Co co 4 This prompt allows to follow the storage INTERNAL MEMORY MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 59 102 5 SAMPLE ANALYSIS REF M22CT UMVEN O03_ 5 10 2 View TOOLS MENU 7 63 18 11 44 TYPE STANDARD ONCZIO OO NNN SELECTION H NB PAGES 530 N SEQ sFROM RESULT TALISATION IN RES ULD NOT EXCEED 6 Page 60 102 ER allow to display each result and its TOOLS Keys identification To print send or delete a result press The effects of the TOOLS key are as described in section 5 10 1 The printed
35. C 22 CT performs a home position checking for the three motors The cycle LED turns red None cycle can performed before it turns green Enter your login and password as described in section 3 1 AUTONOMY run indicates the number of samples runs you can perform in CBC or DIF mode calculated with the smaller quantity of reagents MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 47 102 5 SAMPLE ANALYSIS REF M22CT UMVEN O03_ 5 3 REAGENT REPLACEMENT A The reagents must be stored 24 hours minimum at room temperature before use To check the level of each reagent press SE 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 in CBC or DIF mode calculated with the smaller quantity of reagents AUTONOMY CBC run AUTONOMY DIF run Page 48 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT 5 4 START UP RINSING TE SHUT DOWN CALIBRATION QUALITY CONTROL RESULTS SET UP SERVICE 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 RERGENTS Loss WBC 0 5 R
36. CI ID CUOI SES IIC HUC OO 77 Coco E 1 5 Pin 71 CLOSE amp RUN TET BID If no tube holder exist for special vial please refer to the section 5 6 4 to run it Tube holder Tube holder door support Put the sample tube inside the tube holder Page 52 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT To launch the measurement cycle push slowly the door which close itself or press on the screen It is mandatory to change for a new cap after a Maximum of 10 piercing To open the door press OPEN or wait the automatic opening at the end of the measurement cycle 5 6 4 Other vials sample run Wear rubber gloves and wash hands with a disinfectant after completion of work PREVIOUS a TED SCREEN TOOLS MENU 92703 00700 12 00AM ID PID From the MAIN MENU press to access to the other vial WBC 8 0 measurement screen MONS 020 The following prompt appears BAS 4 08 LYNZ 6 6 RBC HGB 6 6 HCT a u MCU a u Mic 5 6 THE NEEDLE WILL GO DOWN Rb TO THE OTHER VIAL bes POSITION ELT 0 3 PLEASE CONFIRM PCT 6 666 PDW 6 6 Press E to allow the down of the needle if not press NO Present the tube of the blood sample under the needle and press on the display The cyc
37. ECHNOLOGY 8 6 HYDRAULIC DESCRIPTION The hydraulic part of the MYTHIC 22 CT is very simple and made of these modules Sampling module Counting bath module Syringes module Optical manifold Optical bench The modules are connected together by semi rigid tubing 8 6 1 Sampling module This module two patents pending enables to pierce the cap of the sample tube with only one needle 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 The sample tube is maintained by a system of tube holder dedicated to each type of tube The tube holder is maintained by a door driven to close or open by a motor 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 reagent commutation valves and the counting bath block with their measurement block including the apertures The counting bath block assembly and these apertures be removed without tool see section 9 3 3 4 5 8 6 3 Syringes module
38. EU b amp or EOS Eosinophils in percentage Eosinophilis EOS gt EOS 4 EOS Eosinophils in value BAS Basophils in percentage Basophilis BAS gt BAS h amp or BAS Basophils in value Page 74 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 8 TECHNOLOGY 8 3 ERY THROCYTE 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 VMC gt VMC h MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration Hypochromia MCHC lt MCHC b Cold Agglutinin MCHC gt MCHC h RDW 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 calculation following the formula MCV 10 RBC The RBC distribution curve analysis allows the measurement of RDW RDW is an expression of the standard deviation divided by MCV This parameter evaluates the RBC anis
39. FICATIONS Parameter Specimen Occurrence Possible Indication of Error on MYTHIC 22 CT action LYM amp Nucleated RBC Erythroblastosis Platelet aggregation Indication NRBC may be detected on the WBC scattergram with 1 amp or N2 amp or L1 amp or HL flags Indication aggregates may be detected on the WBC scattergram with 1 amp or N2 amp or L1 flags Seek for NRBC on smear Seek for Platelet aggregates on smear MON amp Large or atypical lymphocytes Small Neutrophils Lymphoid amp myeloid Blasts Excessive number of basophils Immature monocytes Cause These lymphocytes are larger than normal lymphocytes and tend to overlap the MON clump on the scattergram Indication reduced LYM MON gap with LYM band RL flags Cause These few segmented and granulations lacking Neutrophils tend to overlap the MON clump on the scattergram Indication reduced NEU MON gap with NL flags Cause Blasts are large and polymorphic immature cells that may overlap all normal cells clumps Indication reduced absent LYM MON even MON NEU LYM gap with overlapping population RL amp or NL amp or HL flags Cause in case of basophilia the basophils clump may overlap the MON clump on the scattergram Indication reduced LYM MON gap RL amp or HL amp or NL flags Cause Immature monocytic line cells proliferate in certain pathologies multiple myeloma monocytic leukemia and g
40. HAS This prompt appears to confirm the version is loaded EEN EE UPLO JADED AFT ONF IRMAT ION STRUMENT n REBOOT This prompt appears when the release of the software is failed Choose another version or call your Orph e s representative Page 34 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT REF M22CT UM EN 003 A SPECIFICATIONS 4 SPECIFICATIONS 4 1 ANALYTICAL SPECIFICATIONS Throughput Close tube mode gt 40 samples hour Other vial mode gt 45 samples hour Sampling Volume 18 2 pl approx Measurement Principle WBC RBC PLT Impedancemetry Five part diff Optical flow cytometry 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 103 3 to 100 0 4 or 4 RBC 10 mm 0 1 to 8 0 07 or 3 HGB g dL 1 0 to 24 0 3 or 2 HCT 5 to 70 2 or 3 PLT 105 mm 5 to 2 000 10 or 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 103 mm 100 to 150 RBC 10 mm 8 to 15 HCT 70 to 80 PLT 103 mm 2000 to 4 000 Repeatability Calculated with 20 runs of a fresh whole blood sam
41. IVE FORMAT FLAGS LEVEL CORRECT FACTORS NS L CLOSE TUBE CHECK SY RINGES each Sa INIT PRESS HGB LEDOFF NEEDLE DISMANTLING GEG SESS TREE MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 81 102 9 SERVICE REF M22CT UM EN 003 9 SERVICE The quality of the results and the reliability of the MYTHIC 22 CT 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 completion of work 9 1 MAINTENANCE 9 1 1 Maintenance table NOTA This table is made for an average number of 50 samples per day For more please increase proportionally the number of maintenances MAINTENANCE DAILY WEEKLY QUARTERNALY HALF YEAR ANNUALLY or 3750 cycles or 7500 cycles or 15000cycles User Tech User Tech User Tech User Tech User Tech Reagents level X Start Up X Automatic cleaning X Concentrate cleaning X X Shut down X Cover cleaning X Piston greasing X X In line filter cleaning X X Needle o ring replacement X X Syringes o ring replacement X Motor screw greasing X Pump Drying X
42. Orph e SA All Rights Reserved Page 45 102 4 SPECIFICATIONS REF M22CT UM EN 003 Parameter Specimen Morbus action P Possible Indication of Error on MYTHIC 22 CT See Hgb value and The MCH is determined according to Hgb value and MCH RBC count RBC count The limitations listed for Hgb and RBC interferences may cause indirect interferences The MCMH is determined according to Hgb and MCHC See kgb ena eT HCT values The limitations listed for Hgb and HCT values interferences nee may cause indirect interferences The ROW is determined according to RBC count See RBC count 9 RDW The limitations listed for RBC may cause indirect interferences interferences P Cause Clumped platelets may cause a decreased aggregates on Smear Platelet Aggregation The specimen should be PLT Indication aggregates may be detected on the Severe Microcytosis Megalocytic Platelets RBC agglutination Hemolysis WBC scattergram with N1 amp or N2 amp or L1 amp or HL flags TMPV Cause in case of severe microcytosis microcytes and schizocytes are below the inferior threshold and may be counted with Platelets and cause an erroneously high Plt count Indication RBC TPIt R1 amp or amp or P2 flags Cause may cause a low inaccurate platelet count as these platelets exceed the upper threshold for the platelet parameter
43. P 80MHz to 800MHz IEC 61000 4 3 80Mhz to 2 5Ghz d 2 34P 800MHz to 2 5GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined 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 800MHz 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 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 22 CT is used exceeds the applicable RF compliance level above the MYTHIC 22 CT Should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the MYTHIC 22 CT gt Over the frequency range 150KHz to 80MHz field
44. S PREVIOUS ae EXPIRY CREATED ON 18 12 83 BY BILL To modify information relative to a batch or to create a new batch please follow the following steps CHRNGE From Calibration Menu press e Select the lot number LOT 25225 TARGETS LIMITS s Je ie modify the lot number press Li e Select the field to be modified e Enter your new value with the numerical keyboard or with the alphabetical keyboard e Press to validate your modifications or the loading e Press ESO to leave the menu without modification e Press tomo to load the target and tolerances values and expiry date and lot number from a USB key Any modification lot number date or target values involves the deletion of all the associated results always in memory Page 70 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 7 PREVIOUS E SCREEN SN roos MENU a 26 Plug the USB key then LOT RBC123 Select the right lot then press i c o Co Go Go o n rd o c 1D c o A co ho OO 4 On crt CO Po 00 YOU CONFIRM TO LOAD THE FILE RBC123 Press Aes to confirm the loading of the target and tolerances values and expiry date and lot number No MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Pa
45. SET UP 3 1 USER S IDENTIFICATION 3 1 1 Start Up After the instrument s initialization the identification window is LOGIN ert displayed In the window LOS the last operator s identification anej eem T appears Either the identification is yours press PASSWORD L land enter your AUTONOMY CBC run sea 2 a z AUTONOMY COIR sun password or the identification is not press to enter your login ENGLISH The window enables to change the language Press lt to validate it AUTONOMY run indicates the number of samples runs you can perform calculated with the smaller quantity of reagents 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 22 CT proposes 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 3 6 3 1 2 In process E SHUT DOWN CRLIBRRTION QUALITY CONTROL RESULTS SET UP SERUICE OPERATOR LOG OUT RERGENTS LOGS RUN SAMPLE OTHER VIAL CLOSE TUBE To change operator during the process press to return to the OPERATOR LOG OUT main menu and then press on To change identification proceed as described above section 3 1 1 MYTHIC
46. T Copyright Orph e SA All Rights Reserved Page 61 102 6 QUALITY CONTROL REF M22CT UW EN 003 6 QUALITY CONTROL 6 1 INTRODUCTION Quality control allows checking the stability of the MYTHIC 22 CT analytical performances when operating Orph e recommends to use the following controls Myt 5D tri level code number MYT502 Myt 5D Normal level code number MYT506 The control blood must be used before its expiry date and stored according to the manufacturer instructions for use It must be well mixed before use according with the instruction for use In case of no local regulation it is recommended to runa 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 calibration see section 7 6 2 QC MYTHIC 22 CT stores in memory up to 100 results per lot for 6 different lots Results of each lot can be viewed in tables and Levey Jennings graph PREVIOUS SCREEN 001 5 T 92 0 QUALITY CONTROL Press to have access to the quality control SHUT DOWN menu CALIBRATION QUALITY CONTROL RESULTS SET UP SERVICE OPERATOR LOG OUT REAGENTS Loss mer vi OTHER VIAL CLOSE TUBE PREVIOUS SCREEN MENU 2 Quality control display presents the identification of the lots The last active lot is labeled with a dark dot on the left l
47. TFT Color LCD 240 320 Mode portrait Retro lighted Barcode option Barcode reader C39 Barcode 2 interleaved 5 Memory capacity gt 1500 Files Demographics results and histograms in the internal memory gt 60 000 results in a memory stick USB key of 512 Mbit or more QC 6 levels 100 Files per level Connection RS 232C Ethernet TCP IP USB MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 37 102 4 SPECIFICATIONS REF M22CT UM EN 003 Reagent Consumption ml Software Version gt V2 2 0 005 CT ee Control 1 148 O45 Reagent L A 0 45 56 Lysis Prime 5 7 Diluent 30 _ 35 Shut Down 1 69 05 2 Latex RBC 170 Latex OPT 1 1300 09 Latex 1300 09 Latex 1300 09 Optical Led 10 Consumption with one run sample add one or two run sample DIF consumption if needed POWER SUPPLY BLOCK Dimensions Height 55 mm Width 127 mm Depth 230 mm Weight 1 32Kg Power supply Input 100 to 240VAC 2A 230VAC at maximum load 4 115 at maximum load 50 60Hz PRINTER LX 300 option 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 A4 P
48. UN SAMPLE RBC 0 1 amem mue H6B 05 PLT 10 If the level is higher MYTHIC 22 CT displays a window START UP FAILED press OK and perform a new start up If the user chooses to run samples every result will be printed with Start Up not done message 5 5 PREPARATIONS BEFORE ANALYSIS 5 5 1 Anticoagulant and mixing The human blood venous sample must be collected in an EDTA K2 or K3 Ethylene Diamine Tetracetic Acid two or tri potassic tube in sufficient quantity The 5 part diff results are available up to 48 hours after the blood draw and if the sample is stored at 4 to 8 C 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 The results and the number of flags could be affected in case of too much sampling more than 20 times A volume of insufficient blood for the quantity of anticoagulant or a bad mixing may involve an erroneous result 5 5 2 Blood sample collection tube The following table shows the type of sample collection tubes available with the MYTHIC 22 CT The use of another types of sample collection tube could destroy the sampling needle or give false results please contact your Orph e s representative before to use this other type The more important close tube characteristics are the length and diameter for the tube holder the cap which contains the rubber membrane for th
49. UU ERREUR REOR EUR PG I iere ee 84 9 114 In line filtercleahifg in terere b de 85 9 2 HYDRAULIC CYCLES 9 3 MECHANICS 9 4 9 4 1 Emergency stop 9 4 2 Needle or o ring replacement 9 4 3 5 6 cic d 9 44 Baths o ring replacement eet e ER ERR UE ea erii in EA 9 4 5 Aperture block replacement 9 5 TROUBLESHOOTING 9 5 1 Analytical problems 9 0 ZONELE prODIEMS Uc NM IM MEME 9 6 TROUBLESHOOTING MESSAGE IT LOGS zl Lc M 9 8 HYDRAULIC DIAGRAM MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 11 102 ALINSTALLATION REF MZZCT UWEN 003 1 INSTALLATION 1 1 UNPACKING 1 1 1 Introduction The MYTHIC 22 CT 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 be used The optimum performances can be only achieved if the cleaning and maintenance procedures are carefully followed If the MYTHIC 22 CT has been stored at a temperature lower than 10 C it must be let at room temperature during 24 hours 1 1 2 Unpacking Procedure Before unpacking the instrument we recommend to check the box of the instru
50. ack to the previous display Press Lem to load the target and tolerances values the lot number and expiry date from a USB key Pow PREVIOUS SCREEN LOT ABC123 CBC toro EINE SE al ZER456 m 458JFD DIF CBR488 DIF WXC789 NI cec AEC128 L cec 2 8456 BHAFD N OIF CJJT288 L DIF c2c3789 H OIF KKDF88 OIF 85 L DIF MEK3781 L DIF p 1 l 1 3 Select the right lot then press oen Press es to confirm 4 MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 63 102 6 QUALITY CONTROL REF M22CT UM EN 003 6 2 2 Run control blood PREVIOUS E I ERLEN LES LOTS 01640 CBC C 1581 N CBC 1762 L CBC 1762 L CBC eee e 11 2 6 18 49 2 3307 4 E 12 71 5 55 ENS 45 51 3151 i 6 00 35 2 EN 22 14 5145 2 ser EN 2 225 16 6 72 2212 25 16 8 7 Em 11 2 6 18 49 2 330 Bc LOT 01642 H CBC m aee T 9 01 9 00 8 8 8 8 ER 8 8 ol LEA 8 8 8 81 ST PREVIOUS fp TOOLS MENU E LE THE NEEDLE WILL GO DOWN TO THE OTHER VIAL POSITION PLEASE CONFIRM Bc LOT 01642 H CBC w m pec HGB HOT LELI LUGI 3 0 0 001 0 0 0 0 al a 5 01 6 001 a a a a al a 6 01
51. and are not counted Indication Pit TMPV P2 flag Cause agglutinated RBC may trap platelets and cause a low inaccurate Plt count Indication abnormal MCH and MCHC values Cause hemolysed samples contain RBC stromas that cause a high inaccurate Plt count Indication abnormal MCH and MCHC values recollected in sodium citrate anticoagulant and re assayed Seek for microcytes on Smear Seek for megalocytic platelets on Smear Seek for clumped RBC on Smear Instrument count is affected by an increase in the result Instrument count is affected by a decrease in the result Instrument count is affected by either an increase or decrease in the result which is sample dependent Page 46 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT REF M22CT UM EN 003 5 SAMPLE ANALYSIS 5 SAMPLE ANALYSIS 5 1 VERIFICATIONS BEFORE STARTING Before starting MYTHIC 22 CT 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 If needed switch on the power supply the power supply can stay on Press ON OFF button INFORMATION EM UPDATE NOT EXCEED 3 LOGIN BILL PASSWORD pz ENGLISH x AUTONOMY CBC run AUTONOMY DIF run on the Mythic The initialization menu is displayed and MYTHI
52. ate and Time System status section 3 2 TOOLS HEHLI Cleaning and stand by mode START UP QUALITY CONTROL REAGENTS RUN SIMPLE Log In and Log Out section 3 1 OTHER Reagent replacement section 5 3 Analysis performing section 5 5 Mythic Events Logs section 5 9 MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 21 102 2 GENERAL OVERVIEW REF M22CT UMV EN O03_ 2 3 2 Dilution fluidic part All the fluidic part is on the right side of the instrument and consist of only three modules Sampling module o Rocker patented Manages the rise and descent of the needle Syringe module patented 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 240 000250 e 1 260 1407 236 4 B Optical bench JE SS m 1 41 Sampling module I a Ju N s3 a A pay ais A he Ny i Syringe module 22 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 2 GENERAL OVERVIEW 2 3 3 Mono electronic board LIENS The mono electr
53. baths and the flow cell with diluent press To perform a cleaning of the aperture blocks and the flow cell with the cleaner press To perform a back flush in the aperture blocks and the flow cell press Page 86 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 95 9 3 MECHANICS TS EFE NEUEN 73 SCREEN TOOLS MENU Fo To have access to this cycle press UE from the MAIN MENU then press creck vecves and SES see below creck NEEDLE performs a complete test of the needle ce Rocker performs a complete test of the rocker __ CHECK SYRINE performs a complete test of the syringe nue Switches on or off the pump to check it L emer switches on or off the HGB led to check it uen oe Switches on or off the optical led to check it MEME DISHANTLINS see section 9 4 2 _LUBRICATION Pos see section 9 1 3 cen E ES This screen allows to check if the different sensors are available in case of problem il PRESSURE TEMPERRTURE FSC ALL i NOTA To understand the function of each sensor we recommend to do an Orph e s training HOME NEEDLE HOME SERINGUE HOME ROCKER DOOR SWITCH HOLDER TYPE SENS T iii Range of trigger temperature measured by the sensors TUBE 1 TUBE 2 TRAP CLOSED Ambient 17 C lt gt 35 C TUBE 3 p TRAP OPENED Encl
54. d 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 MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 95 102 9 SERVICE REF M22CT UM EN 003 PARAMETERS PROBLEMS CONDITIONS SOLUTIONS HGB No result Check the led light on Bad stability Check if no bubble in the lysis tubing Check the reagent and enclosure temperature Check the level bubble flow in the WBC bath during the run cycle Rejection Close the door Perform a new Start Up cycle Flag INS_H Close the door Perform new Start Up cycle 9 5 2 Other problems ORIGIN PROBLEMS SOLUTIONS MYTHIC Diluent leaks around the needle Check the rinsing needle block presence of clots and clean it if during the run cycle necessary Clean the needle for removing the grease in the grooves see section 9 4 2 No starting Check the power supply connection wires Check the switch on button located on the power supply block All results bad Check the level diluent and if the tubing is pinched Check if the diluent is at the same level than the analyzer No display Check the flat cable ID and or PID typing impossible ID and or PID are mandatory see section 3 4 3 Message TEMPERATURE OUT Check the origin of the problem of te
55. ded and after completion of work wash hands with disinfectant Always replace or use parts of the equipment supplied by ORPHEE s representative 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 The treatment of waste and the elimination of a part or the complete instrument must be done in compliance with the local legislation Any output or input connections except the printer and the barcode reader supplied by ORPHEE cannot be done without the ORPHEE representative authorization Do not open the door located on the right side of the instrument see section 1 1 3 when a fluidic 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 22 CT Copyright Orph e SA All Rights Reserved Page 3 102 REF M22CT UM EN 003 This equipment needs special precautions regarding general requirements for safety Guidance and manufacturer s declaration Electromagnetic emissions The MYTHIC 22 CT is intended for use in the electromagnetic environment specified below The customer or the user of the MYTHIC 22 CT should assure that it is used in such an environment Emissions test Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Compliance level Class A
56. disposal legislation If any doubt call an emergency center MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 39 102 4 SPECIFICATIONS REF M22CT UM EN 003 4 3 2 Lytic reagent OnlyOne ORPHEE code number HM22 002 1 Opening shelf life 60 days Application OnlyOne Lytic reagent is used as unique leukocyte and hemoglobin reagent to lyse red blood cells enable cells subpopulations differentiation and counting and quantitatively determine hemoglobin content of blood samples on MYTHIC 22 CT see section 8 Active components alkaline salts and buffering means ionic and non ionic surfactants mix Leuko protective agents non toxic Hemoglobin chelate Preservatives Description clear pale yellow aqueous solution with slight characteristic smell composed of alkaline salts inorganic buffers leukoprotective agents detergents a non toxic hemoglobin stabilizing chelate and preservatives NOTA This reagent does not contains any cyanide neither formaldehyde nor azide Storage At room temperature until expiry date labeled on the bottle Precautions cause skin and eyes irritation Wear a smock gloves and glasses during manipulation First emergency care Inhalation Breathe fresh air seek for medical advice in case of persisting symptoms Eyes Abundantly rinse opened eye during 15 mn Skin Abundantly rinse during 15 mn seek for medical advice in case of persisting symptoms Inges
57. e as an incompatible tree structure for the analyzer try another one The USB thumdrive as an incompatible tree structure for the analyzer try another one The USB thumdrive as an incompatible tree structure for the analyzer try another one No memory available in USB for storage You have to delete some data to work Connect an USB thumdrive The USB thumdrive as an incompatible tree structure for the analyzer try another one The USB thumdrive as an incompatible tree structure for the analyzer try another one The USB thumdrive as an incompatible tree structure for the analyzer try another one The USB thumdrive as an incompatible tree structure for the analyzer try another one The USB thumdrive as an incompatible tree structure for the analyzer try another one Select the right version Replace the waste container MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 99 102 9 SERVICE REF M22CT UM EN 003 9 7 LOGS ERRORS PREVIOUS SCREEN TOOLS MENU 2 PREVIOUS SCREEN HOUR TERRI 23 06 20 51 275 INTERN RESU 04706 64 09 252 BACKUP SYST 05706 12 27 881 BACKUP SYST 06706 28 45 882 BRCKUP SYST 04 03 083 BRCKUP SYST 22 06 12 21 884 BRCKUP SYST 09786 29 39 885 BRCKUP SYST 18786 84 57 886 BRCKUP SYST 21 26 84 15 587
58. e diluent leak and the results will be altered 9 4 3 Baths dismantling This procedure must be carried out to replace the bath seals on the manifold or the aperture seals Wear rubber gloves and wash hands with a disinfectant after completion of work From the MAIN MENU press EE M then press Press ms to perform a draining of the counting baths Open the door located on the right side of the instrument to have access to the hydraulic part MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 91 102 9 SERVICE REF M22CT UM EN 003 To remove the counting bath module pull 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 remove the tubing fixed on the RBC counting head located on the right side of the counting module Page 92 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 95 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 MYTHIC 22 CT Copyright O
59. e only NEU Neutrophils in amp DIF mode only EOS Eosinophils in amp DIF mode only BAS Basophiles in amp DIF mode only Erythrocyte parameters RBC Red Blood Cells HGB Hemoglobin HCT Hematocrit MCV Mean Corpuscular Volume MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration RDW Red Blood cells Distribution Width Thrombocyte parameters PLT Platelet MPV Mean Platelet Volume PDW Platelet Distribution Width PCT Thrombocrit For Investigation Use only in the United States of America MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 19 102 2 GENERAL OVERVIEW REF M22CT UM EN O03 _ 2 2 OVERVIEW MYTHIC 22 CT consists of 8 main parts 1 Display Keyboard 2 Dilution hydraulic part 3 Mono electronic board 4 Reagent tray 5 Connection 6 External power supply block 7 Printer 8 Barcode reader option 2 3 MAIN PART DESCRIPTION 2 3 1 Display Keyboard Stand By and ON OFF button Numeric keyboard Delete DEL Exit ESCAPE Cursors FLAGS Cycle in process ce Led Touch screen LCD display 380 240 Page 20 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 2 GENERAL OVERVIEW Main Menu description Print Start Up rinsing Send Direct access to Back to previous and Blank control Select main menu screen Options D
60. e piercing module The close tubes serial numbers below are showed only as example please contact your tube vendor for more details about EDTA and VACCUM contain The minimum volume of blood required the sample tube is 300 1 MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 49 102 5 SAMPLE ANALYSIS REF M22CT UMVEN O03_ BD 368861 13x75 BD 368452 13x75 7 a BD 367651 13x75 i z 4 T RSET wher mi BD 367652 13x75 VENOJECT 13x75 TERUMO y VENOSAFE VFO54SDK 13x75 TERUMO VACUETTE 454036 13x75 154036 10 5 6 ANALYSIS 5 6 1 Introduction It is recommended or mandatory according to the legislation to carry out a Quality Control QC and possibly a calibration before any analysis see section 6 amp 7 Read the analytical limitations see section 4 4 before run the sample The working temperature of the fluidic part must be reached before starting the analysis The average time to reach it is around 15 min at a room temperature gt 23 C see 5 6 3 If the quality control is not carried out before beginning the series it is recommended to perform two analyses normal sample of the day before to verify if the results are closed to results obtained the day before NOTA The MYTHIC 22 CT is delivered with a standard parameter settin
61. e start the Mythic Delete the calibration results Check if the USB thumb drive is connected to the analyzer Re start the Mythic File has been restored to previous state Memory full next result will not be saved You have to delete results File has been restored to previous state Indicate that your SETUP has been restored Delete results Delete the stored results A bad Result storage happened A bad Result storage happened A bad Result storage happened A bad Result storage happened Delete the results of the ongoing lot Internal database as been restored after detecting incoherent Delete the repeatability results Hardware failure on memory Indicate that your SETUP has been released 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 again if the problem occur call an Orph e representative Perform a control cycle Check the pump connection Emergency stop please perform a control cycle Wait before performing a cycle Change the valve Perform a control cycle Close the Fluidic door Run Control cycle Run Startup Cycle If the problem still occurs Call an Orph e representative Perform an initialization or a control cycle May occurred by leak of reagent or check tubing in the fluidics Change the valve Replace the container and perform a prime Diluent Check the hardware connection on
62. e the MYTHIC 22 CT for the first time it is necessary to perform complete prime of the fluidic circuit This operation should be done by a Field Service Engineer Before starting be sure that all the reagent and waste tubes are properly connected The reagents must be stored 24 hours minimum at room temperature before use Priming procedure INFORMATION 0 switch TER Connect the power supply block Switch on the power supply see section 2 3 4 The power supply can stay switch on all the time Press the ON OFF button The cycle LED turns red No cycle can be performed before it turns green The information window could stay up to 3 min to enable the update of all the files Login E The operator s identification display appears PASSWORD Enter the user s identification the password see section 3 1 and press Anej ok to validate AUTONOMY run indicates the number of samples runs you can 2 on perform calculated with the smaller volume of reagents AUTONOMY D run 2 If this window appears it means that several SONE RESULTS HAVE results in memory have not been sent before the eee ean asa MYTHIC 22 was switched off undi Press YES to send them immediately or press LATER to postpone them or NO if you do not want to send them No USB key is available connect an USB key then pr
63. elow the FT STARTUP ALARMS 7 ALARMS UNITS 5 printing report o ABSOLUTE DIFF With tag absolute values for sub populations of leucocytes are displayed In the other case percentages are BAR CODE READER PID 10 510 displayed ee QC ALARMS The message QC failed appear below the printing 7 REJECT report when the QC result is out of tolerance or expired The PANIC 2 EM message QC not done appear below the printing report when it is v LIMIT HIGH LIMIT LOW 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 or 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 to validate your choices or ESE to exit keeping the previous setting 3 4 4 Lab parameters PREVIOUS SCREEN MENU srenonno STANDARD Select the blood type in the combo box dns then press to adjust the normal and panic limits see section 3 4 4 1 THRESHOLDS FLAGS LEVEL CORRECT FACTORS RENAME TYPES THRESHOLDS 2 to adjust the parameters thresholds see section 3 4 4 2 FLAGS LEVEL este to adjust the flags level see section 3 4 4 3 CORRECT FACTORS to adjust the corrections factor
64. enerate a band at the right of normal MON clump that causes an inaccurate high level of monocytes Indication diffuse MON clump with right end flame population IC amp or L5 amp or NL flags Seek for Erythroblasts on smear Seek for blasts on smear Seek for basophils on smear Seek for immature monocytes on smear NEU amp Excessive number of eosinophils Immature granulocytes Cause The excessive presence of eosinophils eosinophilia may interfere with NEU counting Indication EOS clump is overlapping NEU clump NH flag Cause metamyelocytes myelocytes promyelocytes blasts or plasma cells are large and polymorphous cells that may overlap NEU clump Indication diffuse spreading out NEU clump NL amp or RL amp or IC amp or L5 flags check the eosinophils clump on the scattergram to eliminate eosinophilia Seek for immature cells on smear Instrument count is affected by an increase in the result Instrument count is affected by a decrease in the result Instrument count is affected by either an increase or decrease in the result which is sample dependent MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 43 102 4 SPECIFICATIONS REF M22CT UM EN 003 Occurrence Parameter Specimen Possible Indication of Error on MYTHIC 22 CT Cause Toxic or abnormal granules as much as EOS Granulations degranula
65. ero dU AE date Nee tede ud aid terre eat Ve dg Ne ku d vaa 12 c M 12 PAL Intred ction Joe tenido eed ee 12 14 2 Unpacking Proced re 55 irre eli tutes hie cubes sien eire eitis 12 1 1 3 Visual checking 1 2 INSTALLATION CONSTRAINTS ENEKE E A Le Installation pce etc dee este nee orte rd 1 2 2 Installation environment 1 3 ELECTRICAL 5 1 3 1 Power supply block L4 PRINTER CONNEGTION vet beta aste vet ee tva a vec oo veta EE bet Oen eco eue 1 5 CONNECTION CHANGE AND PRIMING REAGENTS siennes 15 1 5 1 Connection 2 2 2 1 7002000000000 000000004 1 5 2 Priming 1 6 TRANSPORTATION AND STORAGE 2 GENERAL OVERVIEW ioo ce hab ciate nnd ev Snags Cha andes NT e I BEND AIRES Dane Us 2 1 GENERALI TIES ER ni a vn tn n ine 2 2 OVERVIEW 2 3 MAIN PART DESCRIPTION 2 31 Display y 42r 2 3 2 Dilution fluidic part icc et teme rete do a 2 3 3 Mono electronic board T As ae 2 34 Power Supply Blocks IER EROR AER RERO AER ens 2 3 5 Reagent Tray 3 secar deed Ive ai d d rH e pee tbe e e en t uet tete e teet 3 INSTRUMENT SET
66. ese flags can be modified by the user see section 3 8 5 1 General Flags The following alarms are common for all parameters XXX Counting or measure rejection Can appear with WBC RBC PLT and HGB see section 8 5 3 for HGB and section 8 5 2 for DIF parameters XXXD Higher than linearity limits but lower than the reportable limits WBC RBC PLT HGB D Higher than the reportable limits WBC RBC PLT HCT HGB Rejected value h results higher than normal value b results lower than normal value H results higher than panic value B results lower than panic value Page 76 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 _ _ 8 TECHNOLOGY 8 5 2 Instrument Flags CL Suspicion of WBC aperture clog if it persists run a concentrated cleaning see section 9 1 2 R CL Suspicion of RBC aperture clog if it persists run a concentrated cleaning see section 9 1 2 O_CL Suspicion of Optical injector clog if it persists run concentrated cleaning see section 9 1 2 OPT Counting gap between resistive and optical WBC count if it persists run a concentrated cleaning see section 9 1 2 INS_H HGB channel saturation runa START UP cycle INS_T A temperature enclosure reagents or ambient is out of range see section 9 5 2 INS_P Pressure default see section 9 5 2 8 5 3 Leucocytes Flags SCATTERGRAM FLAGS NL IC All the followings flags
67. ess YES or see section 3 4 7 to change the archive mode Page 16 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 1 INSTALLATION D Toots MENU Q System priming The main menu is displayed Press on NOTA Todo an emergenc gt in case of problem push shortly on the on off button press the MYTHIC 22 CT performs a complete priming cycle The cycle LED turns red No cycle be performed before it turns green AUTONOMY CBC run AUTONOMY DIF run AUTONOMY run indicates the number of samples runs To prime or to know the quantity of reagent press the dedicated button Press to display the cycle counters Secor ten To reset the counter with the button er DIF RUNS E please contact your Orph e s representative STRRTUP SHUT DOUN MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 17 102 1 INSTALLATION REF M22CT UW EN 003 DILUENT PRIME REAGENTS From the MAIN MENU press ERE then DILUENT to have access to this screen m DILUENT LoT euni Ge Enter lot number the expiry date and the container capacity CRPRCITV ml eee o 19000 CHANGE REAGENT Press to validate the new entry or after changing a new container with the same information CHANGE REAGENT If needed enter the container volume in millili
68. fect 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 Euer E rry SCREEN MENU Printer set up menu is intended to present the printing report PRINT 7 1 To select an option on the report press on the corresponding case M HEADER M FLAGS Az F COMMENTS V CURVES To enter a header press key M UNITS To exit the menu either press Esc to keep the last setting or poem to save the last modifications AUTO PRINT M ANALYSIS M ac STARTUP HEADER ORPHEE MEDICAL Presentation Results MYTHIC 18 3 4 2 Communication EG ES COM MODE HOST NET SUM SERIAL NONE Reserved for Field Service Engineer To set up the connection between MYTHIC and Host TRANSMIT MYTHIC NUMBER HANDSHAKE DELAY ms Page 28 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 3 INSTRUMENT SET UP 3 4 3 Analysis options OPTIONS box o ALWAYS ID and ALWAYS PID To run a sample user mandatory needs to enter a ID and or a PID o RUO With tag the PCT and PDW parameters are displayed printed RUO ALWAYS ID US MODE and send ALuavs PID ABSOLUTE DIF o US MODE The Research Use Only message is printing b
69. g described in section 3 Page 50 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT 5 6 2 Sample Identification From the main menu press the appropriate button RUN SAMPLE to reach the analysis display This prompt appears when the results memory PLEASE DELETE RESULTS is almost full BACKUP MEMORY IS ALMOST This prompt appears when the results memory is totally full BACKUP MEMORY AVAILABLE FOR STORRGI To delete results see section 5 1 The display bottom is reserved for the entry of the next sample identification to run Three fields allow the entry of the identification o ID Patient Name 20 characters max o PID Patient Identification 16 characters max o SID Sample identification 16 characters max a See NOTA SID number is already done See section 3 3 Press a z to accede to the blood type and alphabetic characters Press or to change the measurement mode SID CRT Press see section 5 6 3 or _STHER_VIAL see section 5 6 4 to launch the measurement cycle D J 8 IDENTIFICATION PROCEDURE SID To enter or modify identification place the cursor in the selected field STANDARD Y m E with your finger or the arrow To enter a figure use the keyboard on the right of the screen for a letter use the alphabetic keyboard by pressing accede
70. ge 71 102 8 TECHNOLOGY REF M22CT UW EN 003 8 TECHNOLOGY The innovative technology of the MYTHIC 22 CT is covered by six pending patents A new innovative concept of optical measurement system and an unique lysing reagent were developed to obtain a so small and powerful analyzer 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 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 eae Aperture 7 Electrode Detection area Proportional height to the cell volume Voltage impulse et the electrode terminal Counting Impulse Page 72 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 8 TECHNOLOGY 8 1 2 Five part diff measurement The innovative optical detection system is covered by two patents pending This technology called OCHF for Optical Cytometer Hydrofocus Free is based on an unique and innovative concept of an active sample flow and a passive
71. he results in Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 TOOLS To print send or delete a result press 1 to open the Levey Jennings graph screen This menu enables to display the Levey Jennings graph for each quality control run 48 meer vvi The column on the left shows each parameter with the target values and e 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 J 2 located under the graph enables to display all the registered results me MOWWL FOPOCOCOCD JO0 COD AMOOW OMADA IO ROO D number of the result give the date and the time of the displayed result WAND PNAD OO TOG This menu enables to restore all the information results and targets for the file selected from the USB key to the internal memory Press YES if you are sure to load the selected file i co co e a n Co ND 00 a m GOING TO ITE THE SELECTED WANT TO CONTINUE All the information of the selected file will be overwrite by the one from the USB key Co o fore jw ro
72. ith RBC counting EE Indication VRBC TPIt TMPV P2 flag ne level of WBC may cause an erroneous Centrifuge the sample and Leukocytosis Indication very high WBC 100 000 uL a the re diluted RBC RBC TMCHC Instrument count is affected by an increase in the result Instrument count is affected by a decrease in the result Instrument count is affected by either an increase or decrease in the result which is sample dependent Page 44 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT REF M22CT UM EN 003 4 SPECIFICATIONS Occurrence Parameter APELIN Possible Indication of Error on MYTHIC 22 CT aeren Centrifuge the sample Cause high level of WBC causes excessive light remove WBC and re assay HGB y scatter that interferes with Hgb measurement the re diluted RBC part Or Indication very high WBC gt 100 000 uL TMCHC use reference spectrophotometric method Cause in case of high level of lipids in blood will give T ACUTUM Use reference manual hyperlipidemia the plasma a milky appearance that causes methods and a plasma blank inaccurate Hgb measurement to determine Hab Indication plasma appearance TMCHC 9 Cause in case of high level or abnormal of Abnormal Protein proteins in blood will give the lysed sample Use reference manual hyperproteinemia appearance that causes inaccurate Hgb me
73. k No 004 000 00345 4 Pursuant to Part 15 21 of the FCC Rules any chanaes or modifications to this equipment not expressly approved by C2 The symbol on the product indicates that this product may not 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 6 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT REF M22CT UM EN 003 KONFORMITATSERKLARUNG DECLARATION DE CONFORMITE DECLARATION OF CONFORMITY DICHIARAZIONE DI CONFORMITA Name und Adresse der Firma Nom et adresse de l entreprise Nome e indirizzo della ditta Name and address of the firm 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 il dispositivo medico diagnostico in vitro the in vitro diagnostic medical device Orph e S A 19 Chemin du Champ des Filles 1228
74. le LED 6 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 As soon as the cycle is launched the SID is incremented automatically and thanks to its data processing multitasks the MYTHIC 22 CT is available for the identification of the following sample See section 5 6 2 MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 53 102 5 SAMPLE ANALYSIS REF M22CT UMVEN O03_ 5 7 RESULTS The results of the analysis are sent before the cycle is finished to be checked at the same time as the printer starts D ID NOTA It is not necessary to wait for the end of the result printing to tory launch a new analysis ene The results are sent to the selected unit See section 3 The information located on the right of each parameter corresponds to Her the indicators for out of range limits and for the rejections see section 3 Heic The scattergram and curves of distribution of each cellular population are PLT located on the right screen Under the results a zone FLAGS is reserved for analytical alarms see section 8 5 Press in this zone to have a clear explanation of the flags At the bottom of the screen there are the three inlet fields for the identification of the next sample See section 5 6 2 gore pp amp ose
75. local representative will not be responsible of the quality of the results and of the MYTHIC 22 CT works exclusively with the reagents described in section 4 3 Orph e or its maintenance of the instrument if other commercial reagents are used 1 5 1 Connection Lytic 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 red caps on the OnlyOne bottle red sticker and the blue one on the cleaning solution bottle blue sticker 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 add the tubing straw adaptor supplied with the installation kit Connect the waste tube female connector the outlet the gum 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 on the same level as the MYTHIC 22 CT It is mandatory to collect the waste in a container and to treat it in compliance with your local regulation MYTHIC 22 CT Copyright9 Orph e SA All Rights Reserved Page 15 102 1 INSTALLATION REF M22CT UW EN 003 1 5 2 Priming us
76. measurement and does not appear on the normal results screen The flags L1 and L5 complete the flags N2 and IC cLi cL5 L1 Presence of platelet aggregate erythroblast or small lymphocytes at the left of CL1 L5 Presence of immature cells at the right of CL5 8 5 4 Erythrocyte and HGB Flags R1 Abnormal quantity of microcytes at the left side of CRI R2 Abnormal quantity of macrocytes at the right side of CR2 HGB means bad measure of the HGB blank 8 5 4 Platelet Flags P1 O to CP1 Presence of abnormal quantity of debris or small cells P2 P to CP2 Presence of schizocytes P3 CP3 to CP3 2 Presence of microcytes The RBC and PLT flags appear when the limit OR limit are reached 8 5 5 QC Flags QC F QC Failed This flags appear when the result of the QC run was out of the limits This flag is printed with each result QC ND QC Not Done this flags appear when no QC was run before the analysis of samples This flag is printed with each result See section 6 8 5 6 STARTUP Flags SU F STARTUP Failed This flag appear when samples are run after a bad START UP This flag is printed with each result SU ND STARTUP not done This flag appear when samples are run without START UP running This flag is printed with each result See section 5 4 Page 78 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 8 T
77. ment and notify any damage to the carrier Open the box on the top remove the starter kit Remove the MYTHIC 22 CT from the box Starter kit contents INSTALLATION KIT MAINTENANCE KIT QTY Designation QTY Designation 1 Tubing 23 DILUENT 1 tubing L 500mm 1 02mm 1 Tubing 24 WASTE 1 tubing L 500mm 1 3mm 1 150W switching adapter 1 tubing L 1000mm 1 52x3 2mm 1 European Power line cord 1 Tygon tubing L 500mm 2 06x4mm 1 MYTHIC 22 CT User manual 1 Tubing 50 1 MYTHIC 22 CT Installation Report form 4 jottle cap filter 1 MYTHIC 22 CT Quality Control Certificate 1 Inline filter 1 Screwdriver Slot 1 4 5 Tie wraps 2 Rinsing Head O ring 1 Silicon grease 3gr 1 Short Arm TORX T10 Tool 1 Short TORX T20 Tool Page 12 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 ES INSTALLATION 1 1 3 Visual checking e Open the door the right side with the key provided in the kit To be checked 1 Counting chambers perfectly locked in their manifold B 1 locations A 2 Needle s dismountable system located the rocker 3 Rocker front position 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 tha
78. mperature in section 9 3 OF RANGE or flag INS_T Trigger temperature values Ambient 17 C lt gt 37 C TEMPERATURE OUT OF RANGE Enclosure 33 C lt gt 40 C Reagents 34 C lt gt 45 C Message CYCLE PRESSURE Cases of occurrence DEFAULT or Flag INS_P drain chamber default check the tubing connection of the fluidics PRESSURE DEFAULT DRAIN BATH DEFAULT rinsing head default check the in line filter locking see section PRESSURE DEFAULT NEEDLE 9 1 4 and the pump operation RINSING DEFAULT counting vacuum default perform a piston greasing see section 9 1 3 PRESSURE DEFAULT VACUUM and check the tubing connection of the fluidics COUNTING DEFAULT For all occurrences check also the level of the reagents Printer No printing Check the paper Check the electrical connection Bad printing Check the ink ribbon or the ink cartridge Page 96 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT REF M22CT UM EN 003 9 SERVICE 9 6 TROUBLESHOOTING MESSAGE This section allows to know what to do when a troubleshooting message appears on the screen If the problem go on contact your Orph e s representative MESSAGE ACTION BACKUP FOLDER NOT FOUND BACKUP FAIL TO SAVE RESULT ONTO THE EXTERNAL STORAGE DEVICE THE INTERNAL MEMORY IS USED BACKUP MEMORY IS ALMOST FULL PLEASE DELETE RESULTS HOLDER TOO MUCH STEP DONE ADJUST CYCLE Re start the Mythic R
79. mythic 22 CT Orph e SA 19 chemin du Champ des Filles 1228 CH 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 M22CT UM EN 003 REF M22CT UM EN 003 REVISIONS 01 HC 23 10 06 Creation 02 11 01 08 HC English correction Section 4 2 modified 03 25 05 08 CM HC Update of the prompts 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 2 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT REF M22CT UM EN 003 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 described operation due to risk of contact with materials that may be infectious Indicates hot temperatures surfaces and risk of burns NOTA Indicates important additional information DANGER Misuse of electrical equipment may cause electrocution burns fire and others hazards gt Check that the voltage setting matches the supply voltage Protective grounding is required plug the MYTHIC 22 CT into a
80. n onto USB key if USB key is available result will be store at the end of the sample run MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 33 102 3 INSTRUMENT SET UP REF M22CT UM EN O03 _ Press Use mure DRIVE Former to format USB key The system will format the USB Key and build specific directories for Mythic management USE DRIVE 15 NOT This prompt appears if no USB key is available or if the USB key is not compatible with the instrument TUTGT TUE Press yes if you agree to format the USB key It is mandatory to format the TUE Pee ee USB key on the Mythic before to use it All the information includes in the USB key will be erased 3 4 8 Version release Load a new software version only with the agreement of an Orph e s representative Be sure to load the new upgrade in the right folder on the USB thumb drive If you have any doubt please contact Orph e S A service department or your Orph e s representative Press Lt to load a new software version from a USB key Choose the right version then Press yes only if you are sure to load a new version software m ara ag 1515 The current software version will be erased definitively and replaced by the new one C boul Doug Co boul Ding 00 N 9 w HE VERSION RELEASE
81. n the last 1500 patients with results START UP E m s alarms distribution curves in the internal memory and until a maximum of 60 000 results a memory stick USB key of 512 Mbit or more see QUALITY CONTROL section 3 4 7 RESULTS SET UP SERVICE Press LIS to enter the archive display OPERATOR LOG OUT REAGENTS LOGS RUN SAMPLE 58 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT 5 10 1 Results The Archive display allows to view the results of the analysis Each result is saved worklist of the day 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 55122 located under the table allows to change pages To find a result in the list select the SEQ number wanted press a To view an entire result select the SEQ number wanted press HOEN PID R4857 04 11 04 TOOLS SID 10 04AM To print send delete save in an USB key results press 98 DATE 1 allows to accede to the results date list CALL NB PAGES 36 m It is possible to print send delete or save in a USB key seq sFROM 2
82. nU E eos 7 FAL Calibration 8 toe ete a eo 7 1 2 7 2 TARGET VALUE MODIFICATIONS 8 TECHNOLOGY s ota e Seu tr edes Malla AL SE Vo ees Bhd 8 1 DETECTION PRINCIPLE a tts totns ta sesta t irasceris deine tras rese ive vedere eigene ded 8 1 1 WBC RBC PLT Counting zs 8 L2 Five part diff measuremert uitae ENEE OENE 81 3 Hemoglobin measurement oii eee ee e e cec deg ce deb nr tt a Mtt 82 LEUCOCYTE ANALYSIS data tape lta ta stai del bed be t bte peto dal eta debct da petet bt zd 8 3 ERYTHROCYTE ANALYSTS bs asa asa das asc deca dac dec rc reca dr c do ec rc dcc dece d eec deeds BA ANALYSIS OF PLATELETS cites tesis tasas test rasta vaste na te veste nas t vaste nas te veste raster tel rate v steve ra redes 8 D FLAGS es 8 5 General Flags pibe de hse ede eel PRO e Me en aet e rat aa a tie D 8 5 2 nstr ment Flags e i n IRAE ERE ORIENT ROS ORAN nt 8 5 3 Leucocy dar M 8 5 4 Erythrocyte and HGB Flags ecsessssss
83. o 36 32 to 36 32 to 36 32 to 36 PLT 10 41 10 L 150 to 400 150 to 400 150 to 400 150 to 400 150 to 400 150 to 400 3 4 4 2 Thresholds THRESHOLDS STANDARD WBC The threshold display enables to modify the detection thresholds located on the WBC scattergram and RBC PLT curves see section 8 L1 5 110 asa DIF FLRGS 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 100 Bas 2 869 120 CP3 2 007 ESC INIT DEF to the flags threshold press Once modifications are done press _vau to validate or to exit without any modification Press 1 ner to return to the manufacturer parameter setting T DIF To accede to modification of the scatter gram threshold press nel and Threshold modifications can affect the quality of the results or can affect the alarm detection area We recommend to modify these values only after Orph e s training 2 0 Press 1117 DEF EE to return to the manufacturer parameter setting 5 DIFF THRESHOLDS RAW DATA Nix EE niv aaa WBC
84. o ala ala al 6 01 Page 64 102 Select __ or blood to run the appropriate control To run quality control analysis from a closed vial control blood o Put the control blood in the tube holder Press Repeat this operation as long as needed The results are displayed in line run after run The statistic calculation are shown at the bottom of the display and are automatically done after each run The cursor other parameters 2 allows to display results for the Lor Mexei H CBC The window memory for another blood control lot The column 5E allows to validate or to unselect a result allows access to the results in To run quality control analysis from a open vial control blood o warning window inform that the needle is going to down in front of the front panel Press YES then the needle down in front of the tube holder door Open the vial and enter the needle o Then press eme to launch the measurement cycle Repeat this operation as long as needed The results are displayed in line run after run The statistic calculation are shown at the bottom of the display and are automatically done after each run The cursor 1 other parameters 2 allows to display results for the The window memory for another blood control lot The column allows to validate or to unselect a result allows access to t
85. ocytosis RDW SD MCV Wintrobe constant calculation The Mean Corpuscular Hemoglobin MCH calculation is made from HGB and RBC by the formula below MCH 10 RBC The Mean Corpuscular Hemoglobin Concentration MCHC is made from HGB and HCT by the formula below MCHC HGB 100 HCT MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 75 102 8 TECHNOLOGY REF M22CT UW EN 003 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 lt 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 to measure 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 AN 8 5 FLAGS MYTHIC 22 CT manages 25 different flags These flags allow the user to be alerted if there is a problem which can affect the quality of the results All of these flags appear on the right of the result measure or on blood smear In presence of one or more flags it is recommended to check the result by a conventional NOTA Most of th
86. old Agglutinin Nucleated RBC Erythroblastosis Unlysed RBC Cryoglobulins Platelet aggregation Cause high IgM level may lower RBC and increase MCV Indication TMCV N1 amp or N2 amp or L1 amp or HL flags Indication NRBC may be detected on the WBC scattergram with N1 amp or N2 amp or L1 flags Cause in some rare instance few erythrocytes may not be completely lysed Indication lyse resistant RBC may be detected on the WBC scattergram with 1 amp or N2 amp or 1 amp or HL flags Cause In association with various pathologies cryoglobulins cause the WBC RBC and Hgb to increase Indication high level of all above mentioned items in case of myeloma carcinoma leukemia and other proliferative disorders pregnancy Indication aggregates may be detected on the WBC scattergram with N1 amp or 2 amp or L1 flags Seek for red cell clumping on Smear Seek for NRBC on smear Warm the specimen up to 37 C 99 F for 30min and re assay immediately after Seek for Platelet aggregates on smear Instrument count is affected by an increase in the result Instrument count is affected by a decrease in the result Instrument count is affected by either an increase or decrease in the result which is sample dependent Page 42 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT REF M22CT UM EN 003 4 SPECI
87. ollowing actions o Print the table o Send the results o Delete the results NOTA Use the same procedure to run the repeatability with an open vial MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 67 102 7 CALIBRATION REF M22CT UW EN 003 7 CALIBRATION The calibration of the MYTHIC 22 CT 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 PREVIOUS SCREEN LOT CAL BY WBC RBC HGB HCT PLT The calibration blood must be used before its expiry date be mixed and stored in according with the instructions of use recommended by the manufacturer SAMPLE EXPIRY TOOLS MENU To reach the screen Calibration press the key cn from the main menu This menu sends the following information Lot number of the last used calibrator The expiry date of the current lot LOT CS224 86 81 04 0 ea o Thelast date of calibration TET eum o operator name 9 5 1 000 o The target values 4 25 1 000 ee ie pe The current coefficients of calibration 46 9 1 888 To enter new values or to modify the values press 375 1 000 To calibrate press OTHER VIAL 2 Press E then L rm to print these information see the print out report above to send
88. on in vitro diagnostic medical devices 98 79 EC which apply to it MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 7 102 REF M22CT UM EN 003 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 Annex III Procedimentodi valutazionedellaconformita Conformity assessment procedure Konformitatsbewertungsstelle falls beigezogen Organe respons de l valuat de la conformit si consult N A Organo incaric della valutaz della conform se consultato Notified Body if consulted Ort Datum Lieu date Name und Funktion Nom et fonction Nome e Luogo data Place date funzione Name and function Gen ve le 19 Juin 2008 Philippe Daire RA amp QA Page 8 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT REF M22CT UM EN 003 TABLE OF CONTENTS READ THIS BEFORE USING THE 3 1 INSTALLATION ns A eV d
89. onic board is located between the hydraulic part and the reagent tray The board driven by a 32 bit processor manages the following parts Sample needle rocker syringe block motors Display and keyboard Connexion mode RS232 Ethernet Printer Measurement Counting hemoglobin measurement Data processing External barcode reader board A To avoid all deterioration risks only the field service engineer can touch this electronic 2 3 4 Power Supply Block Switch on off MYTHIC 22 CT is supplied with an external power supply block In the case of replacement of the main power wire supplied with the MYTHIC 22 CT the new one must be in compliance with the local regulation The MYTHIC 22 CT has been certified with the power supply box provided with the machine If another power supply is used with the instrument Orph e or its representative will not apply any warranty on this power supply and on the instrument Please contact Orph e or its local representative before to use such material MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 23 102 2 GENERAL OVERVIEW REF M22CT UM EN 003 2 3 5 Reagent tray INOAIN The reagent tray is dedicated to the OnlyOne lysing reagent and cleaning solution bottles Page 24 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 3 INSTRUMENT SET UP 3 INSTRUMENT
90. osure 32 C lt gt 40 C ENCLOSURE REAGENT 249 o mS Reagents 34 C lt gt 45 C HEAT 100 MODE OFF FORCED MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 87 102 9 SERVICE REF M22CT UM EN 003 MENU To test each valve press the dedicated button To test all the valves press are 9 4 REPAIRING 9 4 1 Emergency stop In case of mechanical or hydraulic problem immediately press the MYTHIC 22 CT will make an emergency stop PREVIOUS ues After having identified the problem it is necessary to perform a Control cycle To have access to this cycle press pem from the MAIN MENU then press emen vi 9 4 2 Needle or o ring replacement The replacement of the o ring is MANDATORY for each disassembling of the needle Wear rubber gloves and wash hands with a disinfectant after completion of work From the main menu press ESS hen 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 Page 88 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 95 The needle is in front of the counting chambers First remove the top of the needle from the clip lets the needle free in front of the clip do not
91. ot LOTS To choose another lot press on the wished lot 1581 N CBC CHANGE 2 L CEC allows the modification of the 2 ASAE IL TEE identification and the target values RESTORE The key allows to restore the data from a USB key OTHER VIAL CLOSE TUBE The key omer allows To view the result table To perform quality control analysis CHANGE RESTORE RESULT OTHER VIAL CLOSE TUBE TOOLS To print or send the targets results and graphics press Page 62 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 QUALTTY CONTROL PREVIOUS ron MENII LOTS Tag the lot number to select then press the appropriate button nBXei581 N CBC 1762 L MILL k Es se allows to save the targets results and graphics in the USB key In this display the user can enter the Lot number o Expiry date Target values and tolerances Level Press or to change the analysis mode to CBC or DIF Press Esc to delete the modifications you made Press to validate your modifications or the loading Lor reserese exprny 9512215 CREATED ON 15 06 84 BY BOB a IMITS WBC LYM MON NEU Eos BAS RBC HCT MCH RDW PLT Press 9 2 to change the Lot number To print the targets and limits come b
92. ould be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the MYTHIC 22 CT requires continued operation during power mains interruptions it is recommended that the MYTHIC 22 CT be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level Page 4 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT REF M22CT UM EN 003 Guidance and manufacturer s declaration Electromagnetic immunit The MYTHIC 22 CT is intended for use in the electromagnetic environment specified below The customer or the user of the MY THIC 22 CT should assure that it is used in such an 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 22 CT 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
93. ple performed commercial MYTHIC 22 CT PARAMETERS RANGE WBC 2 5 gt to 6 0x10 mm LYM lt 5 to 15 MON 10 to 7 NEU 4 gt to 50 EOS lt 10 gt to 5 BAS 40 gt to 2 RBC 2 gt to 4 0x10 mm HGB 1 5 gt to 12 0 g dL HCT 2 gt to 40 0 MCV lt 1 gt to 85 fL RDW 4 gt to 14 PLT 5 gt to 250x103 mm PMV 3 to 8 fL Calculated method CV SD X Xx ERE E N 1 MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 35 102 4 SPECIFICATIONS REF M22CT UM EN 003 Carry Over For each parameter we perform 3 runs from a high concentration sample followed by 3 runs without sample WBC RBC HGB PLT High concentration value 140x10 mm 8x10 mm 20g dL 3000 103 Measured carry over 0 29 0 13 0 0 07 Maximum carry over lt 10 lt 10 lt 10 lt 10 percentage of carry over inter samples is calculated with the following formula Low value cycle 1 Low value cycle 3 Carry over x 100 High value cycle 3 Low value cycle 3 Accuracy Correlation with one commercial instrument HORIBA ABX PENTRA 120 and with normal blood samples without alarm MYTHIC 22 MYTHIC 22 CT PARAMETERS N R R
94. pull a lot the upper needle Remove the sampling module while slightly lowering the clip to the bottom Pull the needle and the rinsing head system towards outside MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 89 102 9 SERVICE REF M22CT UM EN 003 Lift the sleeve only if you want exchange the needle Lets the tubing connected and the sleeve in place if you exchange only the o ring Remove the tubing fixed at the end of the needle only if you want exchange the needle Do not pull the Teflon tubing but the crystal tubing Lets the tubing connected if you exchange only the o ring 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 Page 90 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 95 Remove the o ring Replace the needle and or the o ring Grease only the o ring If the needle is greased the grease could block the grooves and create diluent leak and the results will be altered 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 Do not grease the needle after removing If the needle is greased the grease could block the grooves and creat
95. report is full page with one or two results per page EUST SCREEN To come back to the archive main page press come back to the Main Menu press It is possible to print or send All results Press NB PAGES 36 for printing Selected results Select the first and the last results sea sFROM 9538 Then press 1 mI This message appears when you exit the result screens and it could stay up to 6 mn to FILE UPDATE enable the update of all the files Copyright Orph e SA All Rights Reserved MYTHIC 22 CT REF M22CT UM EN 003 5 SAMPLE ANALYSIS 5 11 STAND BY AND SHUT DOWN E SHUT DOWN CALIBRATION QUALITY CONTROL RESULTS SET UP SHUT DOWN From the main menu press MYTHIC 22 CT automatically performs a shut down cycle All the hydraulic circuits are rinsed then cleaned with the cleaning solution At the end of the cycle MYTHIC 22 CT automatically stops Shut Down can be automatically performed after a setting time see section 3 4 6 SERVICE 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 OTHER VIAL CLOSE TUBE MYTHIC 22 CT must stay at rest with cleaning solution during three hours every 24 hours MYTHIC 22 C
96. rinter Impact 9 needles Speed Up to 300 cps character per second Page 38 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 4 SPECIFICATIONS 4 3 REAGENTS SPECIFICATIONS All the reagents must be stored at room temperature 18 C to 25 C 4 3 1 Diluent ORPHEE code number HM22 003 10 Opening shelf life 60 days Application The diluent is used to carry out the necessary dilutions for the measurement performed by the MYTHIC 22 CT see section 8 Active components Solid content 0 9 Others components Buffer Preservative Description Clear and odorless aqueous solution Storage At room temperature until the 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 seek for medical advice in case of persisting symptoms Eyes Abundantly rinse opened eye during 15 mn Skin not skin irritating Ingestion rinse out mouth seek for medical advice in case of persisting symptoms Accidental release and disposal measure Person related safety precautions Wear protective equipment keep unprotected persons away environmental protection Do not allow product to reach sewage system or water bodies cleaning collecting Absorb with liquid binding material sand diatomite acid binders universal binders saw dust Comply with local and or federal
97. rph e SA All Rights Reserved Page 93 102 9 SERVICE REF M22CT UM EN 003 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 4 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 A 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 to 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 Page 94 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT REF M22CT UM EN 003 9 SERVICE Remove the o ring and replace by a new one or replace the whole part NOTA The WEC aperture block is marked with a figure 8 on the ear and with a figure 5 for the RBC REASSEMBLY PROCEDURE To reassemble the
98. s see section 3 4 4 4 No correction factors with type STANDARD RENAME TYPES To enter a new blood type press SS NOTA The name of the first type STANDARD cannot be change BLOOD TYPE TOOLS Press KH to print the blood type set up PRINT ALL 7 PRINT SELECTED allow to print all the blood type set up about 20 pages printed EXIT __PRINT SELECTED ee only the blood type in the combo box is printed MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 29 102 3 INSTRUMENT SET UP REF M22CT UM EN 003 MENU LOOD 0010010 C C C C C C MENU STANDARD A B m Ho A e E m gt ofofo 100 0 34 0 120 0 37 m a Hi lt fo a s EU SCREEN TYPE STANDARD h 3 Les ayo n exo 1 2 2 45 0 5 e ho ojo ro m oise 30 102 Copyright Orph e SA All Rights Reserved To rename a blood type press then select it then press to accede at the alphabetic keyboard then press to validate or Esc to exit without any modification This display enables to enter normal and panic limits for every 22 parameters given by the MYTHIC 22 CT see section 8
99. sheath The sample flow is introduced in the flow cell under pressure and the sheath is only dedicated to maintain it This principle enables to introduce a large quantity of sample and to use a great dilution rate which allows to do the Hemoglobin measurement with the same dilution The main advantages are High level of reliability of the optical adjustment Only two measurement axes for five parameters High resolution matrix Only one passive sheath with low reagent consumption No hydro focusing system Low level of contamination between two measurements Very low cost flow cell injected plastic Sample flow Optical window Light beam 455 nm wavelength Passive sheath Injector LIGHT INTENSITY WBC CELL OPTICAL DETECTION AREA TIME ALL SAMPLE FLOW For each cell throwing the optical detection area two pulses are generated one for the Axis Loss Light ALL measurement and one for the Forward Side SCatter FSC measurement The result of those two axes of measurement is the high definition matrix that enables to identify five WBC populations FSC MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 73 102 8 TECHNOLOGY REF M22CT UW EN 003 The five part diff is obtained by the optical matrix analysis after action of the lytic reagent pending patent This reagent destroys the RBC and their stromas composes the oxy hemoglobin chromogen and protects
100. ssesssessesecnessessesnecssessesuceuccsecaccuesseeasesucsucsuccucsuesseeasesuesucsecsuceuesaeeasesuesuesuccuceuesaeeaeenueaueseceeceneesses 8 5 4 Platelet Elags iore eie d ans in m RE oO e NEN 85 5 QC Flags oue dpa eda eti bee dl 85 65 56 0 6 E ate 8 6 HYDRAULIC DESCRIPTIONS 25 dead eiuauduadnd alea 8 6 1 Sampling modules oss eet te RO ER MEI Me me GR ee E e es tine aE 8 6 2 Counting bathimodule 3 ene e Ree reiecta e ace t ook eco eta oth eee ete En a nr 8 6 3 Syringes module eter RR NER ERREUR SERENA 8 6 4 Optical iiim 8 6 5 Optical benehi 5er ee ener d e pe ie e re et Re RD URS 8 3 SOFTWARE add 8 81 WindoWs ER RERO los A ee NA NA RM ele ARIA dt HBEAMUTJ TII P 9 Page 10 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT REF M22CT UM EN 003 9 1 MAINTENANCE Re ne ni TE ee 82 9 11 Maintenance fables eere oe t EE EET YU SU REX EUNT REIS E ED HR 82 9 1 2 Concentrate cleaning Jeden eee eee qe e Re p e o te o pel ene eques nee gue 83 9 13 Piston greasing sni eR RE RAE GEHE Re EE
101. sting symptoms Eyes Abundantly rinse opened eye during 15 mn Skin Abundantly rinse during 15 mn seek for medical advice in case of persisting symptoms Ingestion give large amount of water seek for medical advice in case of persisting symptoms Accidental release and disposal measures Person related safety precautions Wear protective equipment keep unprotected persons away environmental protection Do not allow product to reach sewage system or water bodies cleaning collecting Absorb with liquid binding material sand diatomite acid binders universal binders saw dust Comply with local and or federal disposal legislation If any doubt call an emergency center MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 41 102 4 SPECIFICATIONS REF M22CT UM EN 003 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 Occurrence Possible Indication of Error on MYTHIC 22 CT action WBC C
102. t the MYTHIC 22 CT fulfills its function place the instrument on 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 a Indoor use Altitude up to 2 000 c Temperature 18 C to 34 C d Maximum relative humidity 80 for temperatures up to 31 C decreasing linearly to 50 relative humidity at 40 C MAINS supply voltage fluctuations up to 10 of the nominal voltage f Transient over voltages typically present on the MAINS supply g Rated pollution degree IT MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 13 102 1 INSTALLATION REF M22CT UW EN 003 Please contact Orph e s representative if you want to use the instrument in special conditions altitude higher than 2000 m or special power supply conditions 1 3 ELECTRICAL CONNECTIONS All the connectors are in the rear of the MYTHIC 22 CT CONNECTION SYMBOL 2 USB ports Ethernet connection TCP IP External barcode reader RS232C Printer connection Centronics ec mu Host connection RS232C Power supply cord connection 24V Equipotentiality Any output or input connections except the printer and the bar code reader supplied by ORPHEE cannot be done without the ORPHEE
103. ted areas may alter optical properties of Seek for Granulations amp modifications eosinophils and cause an erroneous EOS counting modifications on smear E Indication diffuse downwards spreading EOS clump overlapping NEU clump NH Flag Cause hyper segmented or giant Neutrophils may Seek atypical Neutrophils Atypical overlap EOS clump on mr Neutrophils Indication upwards spreading NEU clump overlapping EOS clump NH amp or IC amp or L5 Flags Cause abnormal cells may overlap the basophils BAS Blasts immature clump and interfere with the basophil counting on emear amp atypical cells Indication absence of LYM MON NEU gap with RL amp or NL amp or HL flags Cause high IgM level may RBC and in RBC Cold Agglutinin Oo ER E IU Seek for red cell Indication TMCV VHCT one Cause in very rare case of severe microcytosis size Severe Microcytosis of microcytes may fall below the minimum RBC Seek for microcytes on Y threshold Smear Indication RBC TPIt R1 amp or flags Cause in case of macrocytosis size of macrocytes Macrocytosis may overcome the maximum RBC counting zone Indication RBC TMCV R2 flag Cause agglutinated RBC may cause a low inaccurate RBC agglutination RBC count 2 eu ped RBC on Indication abnormal MCH and MCHC values Fragmented RBC Couse fragments Gens may agglutinare Seek for schizocytes on and interfere w
104. ter After the replacement of a new container or to prime the diluent press PRIME ee PRIME DILUENT EJ 9 END 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 CRPRCITV ml 9500 0 UE After replacement of the waste container press RESET to initialize the waste calculation 1 6 TRANSPORTATION AND STORAGE Storage temperature 10 C to 50 C If the MYTHIC 22 CT has been stored at a temperature lower than 10 C it must be left at room temperature during 24 hours Before transportation outside the laboratory perform a complete cleaning with a disinfectant in compliance with the local regulation Page 18 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 2 GENERAL OVERVIEW 2 GENERAL OVERVIEW 2 1 GENERALITIES MYTHIC 22 CT is a fully automated analyzer performing hematological analysis on whole blood collected on EDTA K2 or K3 tubes Sampling volume 18 2 pl Two sampling mode closed tube or other vial Throughput close tube mode gt 40 samples hour other vial mode gt 45 samples hour 22 analysis parameters in DIF mode and 12 parameters in CBC mode Leukocyte parameters WBC White Blood Cells LYM Lymphocytes in amp DIF mode only MON Monocytes in amp DIF mod
105. ters 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 79 79 e 79 SILICON 0 38 2 e 1x3mm Q2 1x2 70 mm 2 e 1 3 x 3mm 1 55 x 3 4 mm 2 1 55 x 3 4 mm lt 2 1 x 4 mm 2 2 29 lt 2 79 2 e z lt 3 2 x 6 4 mm s 2 4x4 mm Designation Tubing 5 210 Tubing 6 130 Tubing 8 80 Tubing 12 CT 55 Tubing 13 250 Tubing 14 250 Tubing 17 80 Tubing 18 80 Tubing 22 200 Tubing 3 135 20 Tubing 10 CT 350 Tubing 30 130 Tubing 31 80 Tubing 32 510 Tubing 33 CT 300 20 Tubing 34 CT 160 110 Tubing 35 130 Tubing 36 230 Tubing 37 190 Tubing 38 CT 150 30 Tubing 39 180 Tubing 40 960 Tubing 41 200 Tubing 42 180 2x5 Tubing 43 250 3x15 2x5 Tubing 44 270 Tubing 45 100 Tubing 46 400 Tubing 47 240 3x15 Tubing 48 150 Tubing 49 70 Tubing 50 100 2X20 Tubing 51 180 Tubing 52 50 Tubing 53 60 Tubing 54 365 Tubing 55 140 2x15 Tubing 56 15 Tubing 58 835 165 10 Tubing 59 Tubing 60 CT 430
106. thods and a plasma blank hyperbilirubinemia measurement to determine Hgb Indication lysed sample appearance TMCHC A Cause high IgM level may lower RBC and increase HCT Cold Agglutinin C e Indication TMCV VHCT Leukocytosis Elevation of WBC Cause in case of chemotherapy cytotoxic and Abnormal Red Cell immunosuppressive drugs may increase RBC as well Fragility as WBC fragility leading to a low HCT Indication P1 flag Cause in case of Spherocytosis sphered RBC are hero Spherocytosis smaller than normal RBC leading to a low HCT Smed P y Indication P2 amp or P3 amp or R1 flags Seek for clumped RBC on Cause agglutinated RBC may cause an inaccurate Smear MCV RBC agglutination MCV value Use reference manual Indication abnormal MCH and MCHC values methods to determine the accurate MCV value Megalocytic C 2 7 MEN Seek for megalocytic Platelets platelets on Smear Leukocytosis Indication TMPV P2 flag Cause high level of WBC interferes with MCV determination Indication very high WBC gt 100 000 uL TMCHC Use reference manual methods to determine the accurate MCV value Instrument count is affected by an increase in the result Instrument count is affected by a decrease in the result Instrument count is affected by either an increase or decrease in the result which is sample dependent MYTHIC 22 CT Copyright
107. ticoagulant and mixing elt 5 5 2 Bloodisample collect tom tubes oaeee neie EE rE ERE 5 6 ANALYSIS au 5 6 1 LAT 5i6 2 Sample Identification eee reet etie D 6 3 Close tube Sample oe eae ena eae 5 6 4 Other vials sample r n iens tete tede been edet hende eee dee ke eR HR NA RESULTS 5 8 PRINTING 5 8 1 Model report A4 external printer si ds ja ag 5 8 2 Model report Thermal printer eere re Ieri he ATEA EE A D 9 O65 ri dede d dca S E aded d peo EE E EE E R EE 510 L ReSUl CA a 5 10 2 5 11 STAND BY AND SHUT DOWN 6 QUALITY CONTROL ERR ERR RES RERO RR ENS mui non npe w 22 en ne ee 6 2 2 Run control blood osea le e MEER ERRORS ERE RA EE vender 6 2 3 LeveysJennings graph reed ebbe tbe a ite leet e degeret entre bee OZA RESTORES RP M M 6 3 REPEATABILITY as a alie die aped ed ddp ae eU aeta an oda dnd T CALIBRATION 5 rendir Pv
108. tion give large amount of water seek for medical advice in case of persisting symptoms Accidental release and disposal measure Person related safety precautions Wear protective equipment keep unprotected persons away environmental protection Do not allow product to reach sewage system or water bodies cleaning collecting Absorb with liquid binding material sand diatomite acid binders universal binders saw dust Comply with local and or federal disposal legislation If any doubt call an emergency center Page 40 102 Copyright Orph e SA All Rights Reserved MYTHIC 22 CT _REF M22CT UM EN 003 4 SPECIFICATIONS 4 3 3 Cleaning solution ORPHEE code number HM22 001 1 Opening shelf life 60 days Application Components Description Storage Precautions The cleaning solution is used to carry out the cleaning of the measurement system and hydraulic circuit see section 8 Enzyme Propylene glycol 2 5 10 dangerous component with critical values that require monitoring at the workplace CAS 55 57 6 EINECS 200 338 0 OES long term value 474mg m 150ppm total 10mg m particules Violet dye Clear aqueous solution violet color with characteristic smell At room temperature until expiry date labeled on the bottle Can cause skin and eyes irritation Wear on a smock gloves and glasses during manipulation First emergency care Inhalation Breathe fresh air seek for medical advice in case of persi
109. tistical calculation reminds the lot number of the calibrator The column _2 allows to validate or to unselect a result CALIBRATION To calibrate press or CLOSE amp RUN CALIBRATION CALIB LOT cs224 wes maa 1 01 1 0 1 4 1 6 1 0 MEAN 6 001 6 81 a a E 0 81 6 00 8 01 a a a STDU BETA 6 01 oc e o o e o NOTA Press omes and use the same procedure to run the calibrator open NOTA The results of the analyses performed on one calibrator during the same day remain in the memory and are used in calculations if they are selected MYTHIC 22 CT Copyright Orph e SA All Rights Reserved Page 69 102 7 CALIBRATION REF M22T UMVEN O03_ 7 1 2 Calibration Before to start the calibration unselect the results you do not wish to use for the calculation of the calibration See below section 7 1 1 The key or allows ___ DELETE ALL e To calibrate with the selected results To delete the results Press EEE ah vu p e print the results Press LL mm ses below the print M wec HGB PF rec HeT M PLT To calibrate one or more parameters LEALTERATION Select the parameter opa HOT L PLI CALIBRATION Eu 1 1 6 1 6 1 8 1 6 e Press the key 7 2 TARGET VALUE MODIFICATION
110. 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 result No HGB Check the lysis level Check the right lysis tubing connection to the WBC bath Check the valve Nb 9 HGB OK Check the bath wires Perform a Cleaning Cycle and then a Bleach cycle if unsuccessful Change the aperture block if unsuccessful Bad stobility 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 Check the reagent and enclosure temperature 5 DIFF No result or bad stability No HGB amp WBC Check the lysis level Check the right lysis tubing connection to the WBC bath Check the valve Nb 9 HGB amp WBC OK Perform a Back flush Cycle and then a Bleach cycle if unsuccessful Check the valves Nb 12 13 16 amp 17 Check the reagent and enclosure temperature Check the preampli connection wires Rejection Check the results on blood smear RBC No result No HCT amp PLT Check the bath wires Perform a Cleaning Cycle and then a Bleach cycle if unsuccessful Bad stobility HCT amp PLT Perform a Back flush an

Orphee Mythic 22-CT Hematology Analyzer

Contents

Download Pdf Manuals

Related Search

Related Contents