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Orphee Mythic 22 Hematology Analyzer

1. ORIGIN PROBLEMS SOLUTIONS MYTHIC Diluent leaks around the Check the rinsing needle block presence of clots and clean needle during the run cycle it if necessary see section 9 4 2 No starting Check the power supply connection wires 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 ID and or PID are mandatory see section 3 4 3 impossible Message TEMPERATURE Check the origin of the problem of temperature in section 9 3 OUT OF RANGE or flag Trigger temperature values INS_T Ambient 17 C lt gt 37 C Enclosure 33 C lt gt 40 C TEMPERATURE OUT OF RANGE 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 PRESSURE DEFAULT ORAIN fluidics counting vacuum default perform a piston greasing see section PRESSURE DEFAULT VACUUM 9 1 3 and check the tubing connection of the fluidics For all occurrences check also the level of the reagents Printer No printing Check the paper Check the electrical connection Bad printing Check the black ribbon 9 6 TROUBLESHOOTING MESSAGE This section allows knowing what to do when a troubleshooting message appears on the screen If the problem go on
2. 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 MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 91 99 9 SERVICE REF M22 UM EN 006 part Remove the o ring and replace by a new one or replace the whole NOTA The WBC aperture block is marked with a figure 8 on the ear and with a figure 5 for the RBC REASSEMBLY PROCEDURE To reassemble the unit carry out the various operations in the opposite direction Place the seal on the aperture block gently not to wound it 9 5 TROUBLESHOOTING In any case if a problem is not solved call Orph e s representative 9 5 1 Analytical problems PARAMETERS PROBLEMS CONDITIONS SOLUTIONS WBC No 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 stability Perform a Back flush and a Cleaning Cycle and then a Bleach cycle if
3. MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 81 99 9 SERVICE REF M22 UM EN 006 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 performs a maintenance cycle of the apertures and the flow cell follow with a standby mode during 2 min After 2 min MYTHIC 22 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 LEE cl from the MAIN MENU then press NOTA The greasing frequency must be increase proportionally to the number of samples per day See maintenance table 9 1 1 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 Press _werrcarion pos f to put the piston of the syringe module in the greasing position Page 82 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 9 SERVICE 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 THIN FILM of grease around each piston
4. 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 To have access to the hydraulic cycle press seme from the MAIN MENU then press MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 83 99 9 SERVICE REF M22 UM EN 006 To drain the counting baths the flow cell and the waste syringes press To fill the counting 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 9 3 MECHANICS Eno e SCREEN TOOLS To have access to this cycle press Se from the MAIN MENU then press Lee J see below uc eec performs a complete test of the needle owe Rocker performs a complete test of the rocker CHE Sne performs a complete test of the syringe Ge e see below tee tev oe switches on or off the HGB led to check it switches or off the optical led to check it MEE DISNANTLING see section 9 4 2 __ Pos see section 9 1 3 Page 84 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 Ens era REUIOU ff nenu REF M22 UM EN 006 9 SERVICE TOOLS
5. rrastRUMENT Guo mee meet ume DRIVE FORMAT wr pass il e A CONTROL CYCLE MOTORINIT maay S SES Par ERRORS SJ SE BEAN Mechanic Control cycle NES EN repeats bility control Euro oe REN cse eem CHECK ROCKER CHECK SYRINGES CHECK SEN SORS ERK Ee CHANGE CHANGE CHANGE Ei SSS OTHERVIAL gt Hesse MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 79 99 9 SERVICE REF M22 UM EN 006 9 SERVICE The quality of the results and the reliability of the MYTHIC 22 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 A YEAR ANNUALLY User Tech User Tech User Tech User Tech User Tech Reagents level X Start Up X Automatic cleaning X Concentrate cleaning X Shut down X Cover cleaning X Piston greasing A A Needle greasing X Needle o ring replacement X Syringes o ring replacement
6. EE Press to calibrate Press then PRINT PRINT to print these information see the print out report above SEND Loos to send these information mE to store these information in the USB key SAVE EXIT MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 65 99 7 CALIBRATION REF M22 UM EN 006 NOTA If the M letter appears on the right of the date of calibration that means that the last calibration was done by modification of the calibration factor see section 3 4 5 Model of print out calibration report CALIBRATION IN PROGRESS SER MBER X amp aaaaaa aaaaoa SOF ION Up En PRINTED ON 19 06 2004 15 50 00 BV BILL COEFFICIENTS 1 600 1 8880 1 8880 1 600 1 600 LOT CS224 CREATED ON 18 12 2003 BV BILL EXPIRY 06 01 2004 WBC RBC HGE HET PLT TaRGETS 9 5 4 25 16 5 46 91 375 LIMITS 1 8 a 24 5 2 1 25 COEF 1 8 1 8 1 60 1 8 1 8 MEANT 6 007 6 01 6 6 6 01 e e 7 1 RESULTS 7 1 1 Calibration blood analysis This screen allows carrying out analysis on calibration blood to perform the MYTHIC 22 calibration Present the calibration tube under the sampling needle and press the trigger behind the needle The cycle LED DI located at the top of the needle flickers alternatively of red with green when it becomes red the tube can be removed The results are p
7. Optical Manifold o Liquid valve manifold assembly and tubing Optical bench o Optical bench patented with his flow cell patented Optical bench Optical manifold Sampling module Se d m 7 D M H EM d J Lenci Gan v 4 gt 22 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 2 GENERAL OVERVIEW 2 3 3 Mono electronic board The mono electronic board is located between the hydraulic part and the reagent tray The board driven by a 32 bit processor manages the following parts Sample needle rocker syringe block motors Display and keyboard Connexion mode RS232 Ethernet Printer Measurement Counting hemoglobin measurement Data processing External barcode reader A To avoid all deterioration risks only the service people can touch this electronic board 2 3 4 Power Supply Block Switch on off MYTHIC 22 is supplied with an external power supply block In the case of replacement of the main power wire supplied with the MYTHIC 22 the new one must comply with the local regulation The MYTHIC 22 has been certified with the power supply box provided with the machine The use of another external power supply box is not guaranteed Please contact your Orph e s representative MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 23 99
8. 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 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 doing 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 Sample 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 Page 70 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN
9. 2 GENERAL OVERVIEW REF M22 UM EN 006 2 3 5 Reagent tray The reagent tray is dedicated to the OnlyOne lysing reagent and cleaning solution bottles Page 24 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 3 INSTRUMENT SET UP 3 INSTRUMENT SET UP 3 1 USER S IDENTIFICATION 3 1 1 Start Up LOGIN PRSSWORD 2 ENGLISH AUTONOMY CBC run AUTONOMY DIF run LOGIN PASSWORD SHUT DOWN CALIBRATION QUALITY CONTROL RESULTS SET UP SERVICE OPERATOR LOG OUT REAGENTS LOGS RUN SAMPLE After the instrument s initialization the identification window is displayed In the window 081 BILL the last operator s identification appears Either the identification is yours press PASSWORD L land enter your password or the identification is not press Loi to enter your login ENGLISH The window enables to change the language Press x to validate it AUTONOMY run indicates the number of samples runs you can perform calculated with the smaller quantity of reagents 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 proposes 3 access levels o User No password o Biologist Password by default 1 2 3 o Service people Biologist Password can be modified in section 3 3
10. 6 External power supply block 7 Printer 8 Barcode reader option 2 3 MAIN PART DESCRIPTION Stand and 2 3 1 Display Keyboard ON OFF button Numeric keyboard Delete DEL Exit ESCAPE Cursors Enter ENTER Cycle in process Led Touch screen LCD display 380 240 Page 20 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 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 Date and time System status Section 3 2 TOOLS HERU Cleaning and standby mode Log In and Log Out Section 3 1 Reagents replacement Section 5 3 Analysis Mythic Events performing Logs Section 5 5 Section 5 9 MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 21 99 2 GENERAL OVERVIEW REF M22 UM EN 006 2 3 2 Dilution hydraulic part All the fluidic part is on the right side of the instrument and consists of only five modules Sampling module o Rocker patent pending Manages the rise and descent of the needle Syringe module patent pending consists of one block o Reagent syringes Diluent lysis sampling and air syringes o Liquid valve manifold assembly and tubing Counting chambers o WBC and RBC counting chambers and hemoglobin measurement o Liquid valve manifold assembly and tubing
11. Indication TMCV YHCT 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 N1 amp or N2 amp or L1 amp or HL flags Cause In association with various pathologies cryoglobulins cause the WBC RBC Pit 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 N2 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 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 4 SPECIFICATIONS Parameter Specimen Occurrence Possible Indication of Error on MYTHIC 22 action LYM amp Nucleated RBC Erythroblastosis Platelet aggregation Indication
12. REJECT PANIC HIGH v PANIC Low LIMIT HIGH v LIMIT Low Once modifications are done press either previous setting 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 and send o US MODE The Research Use Only message is printing below the printing report o ABSOLUTE DIF With tag absolute values for sub populations of leucocytes are displayed In the other case percentages are displayed o QC ALARMS The message QC F QC failed appear below the printing report when the QC result is out of tolerance or expired see section 8 5 5 The message QC ND QC not done appear below the printing report when it is not run see section 8 5 5 UNITS STRNDRRD Gives a choice of three unit systems Standard International System and mmol Barcode Reader box The reading of the bar code 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 to validate your choices or ESE to exit keeping the 3 4 4 Lab parameters PREVIOUS SCREEN TYPE STANDARD THRESHOLDS FLRGS LEUEL CORRECT FACTORS RENAME TYPES BLOOD TYPE PRINT SELECTED EXIT TYPE STANDARD Select the blood type in the combo box press to adjust the normal and panic limits see
13. Thermal printer SEIKO DPU 414 model DIF mode CBC mode ORPHEE MEDICAL ORPHEE MEDICAL Presentation Results MYTHIC 22 Presentation Results MYTHIC 22 Name 14 12 2005 Mame 14 12 2005 Patient Id 11 25 56 Patient Id 11 27 39 Sample Id 00017 Sample Id 88818 Type STANDARD Type STANDARD Seat 00032 Seqt 00033 Operator ID SAS Operator ID SAS WBC 5 7 10 3 1 4 07 12 6 WC 5 8 10 3 1 4 0 12 0 LNS 48 2 25 0 50 0 MOI 11 3 h X 2 0 10 0 NEUZ 42 8 L 58 80 80 0 EOS 5 6 z 0 07 5 0 BAS 9 7 z 0 07 2 RBC 5 14 10 6 1 4 00 6 20 HGB 15 4 gdl 11 0 17 0 REC 5 12 10 6 1 4 00 6 20 HET 46 3 a 35 0 55 0 HGB 15 3 9 81 11 0 17 8 MCU 98 0 be 80 0 100 0 HET 46 4 H 35 0 55 8 MCH 29 9 bg 26 0 34 0 t4 f MCU 90 6 e 80 0 100 0 MCHC 33 2 gdl 31 0 35 5 nen 30 9 Sch 26 0 34 0 RDW 13 2 x 18 0 16 0 33 1 g 31 0 35 5 PLT 18 8 1 RDW 13 2 19 97 16 8 MPU 881 n 52 tie PLT 10 3 1 150 400 200 MPU 8 1 m 8 7 0 11 8 oe PCT 248 4 4 200 4 500 12 0 x 18 0 18 0 FLRGS MONOCYTOSIS NEUTROPENIA ORPHEE MEDICAL ORPHEE MEDICAL Presentation Results MYTHIC 22 Presentation Results MYTHIC 22 Name Patient Id Name Patient Id Comments Sample Id 090017 Comments Sample Id 90818 Type STANDARD Type STANDARD Operator ID SAS Date 14 12 2005 11 25 56 Seqt 00032 Operator ID SAS Date 14 12 2005 11 27 30 Seqt 00033 Result Flags
14. PRESSURE TEMPERATURE This screen allows checking if the different sensors are available in case of problem WBC PLT NOTA To understand the function of each sensor we recommend to do FSC an Orph e s training ALL HOME NEEDLE HOME ROCKER START SWITCH ini Range of standard temperature measured by the sensors Ambient 17 C lt gt 37 C Enclosure 33 C lt gt 40 C Reagents 34 C lt gt 45 C ENC TEMPERATURE r o e D m To test each valve press the dedicated button To test all the valves press 9 4 REPAIRING 9 4 1 Emergency stop In case of mechanical or hydraulic problem immediately press e the MYTHIC 22 will make an emergency stop After having identified the problem it is necessary to perform a Control cycle To have access to this cycle press EE from the MAIN MENU then press MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 85 99 9 SERVICE REF M22 UM EN 006 9 4 2 Needle or o ring replacement Wear rubber gloves and wash hands with a disinfectant after completion of work From the main menu pres n 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 The needle is in front of the counting chambers
15. Re start the Mythic Re start the Mythic You have to be Logged with the good access code Perform a new start up cycle This MY THIC can not be connected to the SVM Call an Orph e representative System is resetting after version release Re start the Mythic Re start the Mythic Replace the container and perform a prime Diluent Replace the bottle and perform a prime Lysis USB DIRECTORY DOES NOT EXIST Try again or change for another USB Thumb MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 95 99 9 SERVICE REF M22 UM EN 006 MESSAGE ACTION USB DIRECTORY IS NOT EMPTY USB EMPTY FILE Try again or change for another USB Thumb Try again or change for another USB Thumb Try again or change for another USB Thumb USB THUMB DRIVE IS FULL Delete some files Please connect USB thumb drive to the analyzer USB TOO MANY FILES OPENED USB UNABLE TO CREATE DIRECTORY Delete some files Try again or change for another USB Thumb Try again or change for another USB Thumb USB UNABLE TO OPEN FILE Try again or change for another USB Thumb RELEASE IS NOT COMPATIBLE WITH THE MYTHIC 22 SYSTEM WASTE ALMOST FULL Try again or change for another USB Thumb Select the correct version Replace the waste container Page 96 99 Copyright Orph e SA All Rights Rese
16. dip in UT for 25 cycles 5 UT 295 dip in 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 should 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 requires continued operation during power mains interruptions it is recommended that the MYTHIC 22 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 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 Guidance and manufacturer s declaration Electromagnetic immunity The MYTHIC 22 is intended for use in the electromagnetic environment specified below The customer or the user of the MYTHIC 22 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance Electromagnetic environment guidance level Portable and mobi
17. or MON Monocytes in percentage Monocytosis MON MON h amp or MON Monocytes in value NEU Neutrophils in percentage Neutrophilis NEU gt NEU h amp or NEUZ Neutrophils in value Neutropenia NEU NEU b amp or EOS Eosinophils in percentage Eosinophilis EOS gt EOS h amp or EOS Eosinophils in value BAS Basophils in percentage Basophilis BAS gt BAS h amp or BAS Basophils in value MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 71 99 8 TECHNOLOGY REF M22 UM EN 006 8 3 ERYTHROCYTE ANALYSIS The erythrocyte analysis is done by impedancemetry in the RBC counting chamber and by analysis of the hemoglobin inside WBC chamber as previously described Seven parameters are obtained Parameters Pathologies adjustment section 3 4 4 1 RBC Red Blood Cells Erythrocytosis RBC gt RBC h HGB Hemoglobin Anemia HGB HGB b HCT Hematocrit MCV Mean Corpuscular Volume Microcytosis VMC lt VMC b Macrocytosis VMC gt VMC h MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration Hypochromia MCHC MCHC b Cold Agglutinin MCHC gt MCHC h RDW jRed blood cells Distribution Width Anisocytosis 1 RDW gt RDW hi Hematocrit HCT is measured by integration volume of all of the red blood cells which flow in the RBC counting chamber aperture MCV
18. 127 0 991 HGB g dL 127 0 997 HCT 127 0 984 MCV fL 127 0 947 RDW 127 0 746 MCH pg 127 0 963 MCHC g dL 127 0 151 PLT 105 mm 127 0 990 MPV fL 127 0 890 2x Xy Calculated method rz mm Zx n gt xy PENTRA 120 is a registered trademark of HORIBA ABX Page 36 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 4 SPECIFICATIONS 4 2 PHYSICAL SPECIFICATIONS General Ambient temperature from 18 to 34 Relative Humidity 80 maximum at 32 Storage temperature 10 to 50 temperature during 24 hours before switching it on d If the MYTHIC 22 has been stored at a temperature less than 10 C it must stay at room INSTRUMENT Dimensions 350 mm approx Width 250 mm approx Depth 340 mm approx Weight 12kg approx Power supply Input 24V 5A DC Electric consumption During cycle 75 VA 30 10 Stand By 20 VA 30 10 110 30 10 Display TFT Color LCD 240 320 Mode portrait Retro lighted Barcode option Barcode reader C39 Barcode 2 interleaved 5 Memory capacity gt 500 Files Demographics results and histograms in the internal memory gt 60 000 files 512 Kbit USB key QC 6 levels 100 Files per level Connection RS 232C Ethernet TCP IP MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 37 99 4 SPECIFICATION
19. 5 gt to 6 0x10 mm LYM lt 5 gt to 15 MON 10 gt to7 NEU 4 gt to 50 EOS 10 gt to 5 BAS lt 40 gt to 2 RBC lt 2 gt to 4 0x10 mm H6B 15 gt to 12 0 g dL HCT 2 to 400 MCV 1 gt to 85 fL RDW 4 gt to 14 PLT lt 5 gt to 250x10 mm PMV 3 gt to 8 fL Calculated method CH SD X Xx N N 1 MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 35 99 4 SPECIFICATIONS REF M22 UM EN 006 Carry Over For each parameter we perform 3 runs froma high concentration sample followed by 3 runs without sample WBC RBC HGB PLT High concentration value 145x10 mm 8 40x10 mm 20g dL 2300x10 mm Measured carry over 76 0 68 0 0 0 04 Maximum carry over 10 10 10 10 The percentages 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 was done with one commercial instrument HORIBA ABX PENTRA 120 normal blood samples without alarm and with about 100 PARAMETERS N R WBC 10 mm 127 0 997 113 0 989 113 0 935 NEU 113 0 988 EOS 113 0 950 BAS 113 0 187 RBC 105 mm
20. 56 10mm Tubing 57 80mm Tubing 58 1000mm Tubing 59 8mm Page 98 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 9 SERVICE CLEANER LYSE DILUENT 5 o wo a le 2 a 8 22 38 36 34 sspe wna r m HAS 31SVM TYAS 31SVM LI E HAS 3SA1 NET E m JONIYAS DH Ida ge MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 99 99
21. Cec 458JFD L DIF CBR488 H DIF WxC789 NI cec ABC128 LI cec TRR456 H Cec BHAFD HI OIF CJJT288 L DIF C2C3789 H DIF KKDF88 NI DIF MBK785 LI DIF MEK3781 L DIF EES ee 3 1 1 LOT RBECi23 CBC 2 LEVEL OL ON H GE Tag the lot number to select then press the appropriate button sve 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 o Target values and tolerances o Level Press or to change the analysis mode Press Esc to delete the modifications you made Press to validate your modifications or the loading Press 9 2 to change the Lot number To print the targets and limits come back to the previous display Press Lem to load the target and tolerances values the lot number and expiry date from a USB key Select the right lot then press een Press ves to confirm MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 61 99 6 QUALITY CONTROL REF M22 UM EN 006 6 2 2 Run control blood Press MESRINE the contro blood TOOLS MENU E PREVIOUS SCREEN LOTS MBX81648 CBC MBX61581 N CBC 1762 L CBC C MBKe1762 L CBC C C Before to run the control check and clean the opening of the cover dedicated to the down of the needle to avoid any fall of
22. ER R 5 6 2 Sample uge 563 SOMPE DEE b RESULTS ee DISPRINTINGi MR A RA rai 5 8 1 Model report A4 external pprinter e a t 54 5 8 2 Model report Thermal printer ENEE 55 GIAN riali een GL On RIGO TOMA RCHIVE LARA RO eee AIA E 510 1 Results a in ono ea a ad E A tte RR CA E RE 5 10 2 5 11 STAND BY AND SHUT DOWN sti oos die gei 6 QUALITY CONTROL abdo ro eb les AE ele MA tog Do us 6 1 INTRODUCTION 6 2 1 Change 6 2 2 Run control blood 6 2 3 Levey Jennings graph ette ii 60 24 RESTON Cs NE 6 3 REPEATABILITY ott RE Te CALIBRATIONO s0 0 Cc ro EEUU eo a E UU e A m LL ate AB aaan PARE SUITS EE Lr ii 7 1 1 Calibration blood analysis 7 1 2 Calibration 7 2 TARGET VALUE MODIFICATIONS TECHNOLOGY i oa i IAA I O DIAL 8 1 DETECTION PRINCIPLE 8 1 1 WBC RBC PLT Counting 8 1 2 Five part diff measurement 8 1 3 Hemoglobin Measurement ARR iii 71 8 2 LEUCOCYTE ANALYSIS i e ste ste iste iste ste ste ete ste ete iste aaa aaa 71 BiSSERVTHROCY TE ANALY SIS ee 72 BA ANALYSTS OF PLATELETS Ir 73 BEIS 8 5 1 General Flags on aa ds d T 8 5 2 Instrument Flags eie eee e m ERR GR P HR OR e E PR ERU RE AU 74 8 5 3 Leucoc
23. 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 N1 amp or 2 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 generate 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 See
24. Remove the sampling module while slightly lowering the clip 1 to the bottom Page 86 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 9 SERVICE Draw the system towards outside 2 Remove the tubing fixed at the end of the needle Unscrew the serrated roller which maintains the seal and the needle Leave the serrated roller the needle and the o ring from the rinsing head MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 87 99 9 SERVICE REF M22 UM EN 006 Remove the o ring Replace the needle with or the o ring REASSEMBLY PROCEDURE To reassemble the unit carry out the various operations in the opposite direction Place the seal on the needle gently not to wound it 9 4 3 Baths dismantling This procedure must be carried out to replace the bath seals on the manifold or the aperture seals A Wear rubber gloves and wash hands with a disinfectant after completion of work From the MAIN MENU press a a then press MENU Press Eee 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 Page 88 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 9 SERVICE To remove the counting bath module draw on the clip machine
25. ae anb Date eie eh i Dese tte ehe eie eb e Oe le i n e Ci et 20 2 3 MAIN PART PESCRTETTION cirie 20 2 3 1 Display Keyboard e nac e RR E Gace 20 2 3 2 Dilutiori hydraulic part iine rec d M M Ric TRE REED 22 223 3 MONO electronic board iis yen RE a 23 2 3 4 Power Supply Block m 23 2 3 b Reagent Try indes uee a a aee eea 24 3 INSTRUMENT SET OP rainse a r ete vd erts nette o se sab fie dur etas 25 3 1 USER S IDENTIFICATION iii 25 3 1 1 Start Up 3 1 2 In process 3 2 SYSTEM STATUS S44 Lab Parameters EE 29 3 4 5 Calibration factor 4 3 REAGENTS SPECIFICATIONS dE 43 2 LYTIC REAGENT OMY OME a e ERR RR ee 40 43 3 Cleaning Selten 41 AAANALYIICALLIMITATIONS cca OR 42 44 T RECOMMENDATIONS ed 42 dA LINTE al ol a dal eL e nil ME EM 42 MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 9 99 REF M22 UM EN 006 5 SAMPLE TE EE 5 1 VERIFICATIONS BEFORE STARTING oi ds m DI STARTUP RARA ARA IRON RIA IO I ARIA RIO REI RENI D SREAGENTREPLACEMENT i urna aria DA EE dE 5 5 PREPARATIONS BEFORE ANALYSIS D OA NALLY EES 5 64 zu E E EC
26. b 6o 4 9 6o ho K CH m n Press ves to confirm the loading of the target and tolerances values and expiry date and lot number Page 68 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 8 TECHNOLOGY 8 TECHNOLOGY The innovative technology of the MYTHIC 22 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 on a side of the aperture allows the cells passage They oppose their physical volume to the course passage A voltage impulse is registered at the electrodes terminal The height of this impulse is proportional to the cell volume VACUUM Time Lee Aperture 7 Electrode Detection area Proportional height to the cell volume Voltage impulse et the electrode terminal Counting Impulse MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 69 99 8 TECHNOLOGY REF M22 UM EN 006 8 1 2 Five part diff measurement
27. contact your Orphee representative MESSAGE ACTION MEMORY IS USED BACKUP CALIBRATION HISTORY IS FULL BACKUP FAIL TO SAVE RESULT ONTO THE EXTERNAL STORAGE DEVICE THE INTERNAL Re start the Mythic Re start the Mythic Delete the calibration results Please connect USB thumb drive to the analyzer Re start the Mythic BACKUP LAST RESULT SAVED Memory full next result will not be saved You have to delete MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 93 99 9 SERVICE REF M22 UM EN 006 MESSAGE ACTION BACKUP MEMORY IS ALMOST FULL PLEASE DELETE RESULTS BACKUP QC HISTORY IS FULL CYCLE STOPPED BY USER CYCLE EMERGENCY STOP CYCLE HGB CHANNEL SATURATION PLEASE RUN STARTUP TD AND OR PID MANDATORY CHECK SETUP SID ALWAYS MANDATORY INTERN MEMORY CORRUPTED INTERN RESULT AREA IS LOCKED MECA HOME ROCKER NOT FOUND Delete the stored results Delete the repeatability results hardware failure on memory Replace the bottle and perform a prime Cleaner Orph e representative Perform a control cycle Emergency stop please perform a control cycle Change the valve Perform a control cycle May occurred by leak of reagent check tubing in the fluidics Change the valve check the hardware connection on ALL Board check the hardwar
28. graph PREVIOUS SCREEN TOOLS MENU d NADOG ONO ONOAG WII OOOO 0000000000 6 5 5 5 5 9 9 2 8 T 3 3 3 2 2 4 3 E 3 2 1 1 AOMWOOW CONI Oho WOOD f PREVIOUS EM LOT RBCi23 CBC U 05 04 MENU TOOLS LEVEL TEST B ot Ceci ZER456 NI cec SR 458JFD L DIF CBR488 HIT DIF WXC789 NI cec ABC128 CT ec 2 456 HI cec EHRFD HI DIF CJJT288 CT DIF c2c3789 HI DIF KKDF88 HI DIF MBK785 CT DIF 1 MBK3781 1 LI DIF MBKS Sli poe This menu enables to display the Levey Jennings graph for each quality control run The column on the left shows each parameter with the target values and the limits The value under the name of the parameter is the value where the cursor is located on the graph The keys lt gt gt enable to display the other results The cursor A 2_ located under the graph enables to display all the registered results number of the result give the date and the time of the displayed result This menu enables to restore all the information results and targets for the file selected from the USB key to the internal memory YOU ARE GOING TO QVERWRITE THE SELECTED 00 YOU WANT TO CONTINUE Press YES if you are sure to load the selected file All the information of the selected file will be overwrite by the one from the USB k
29. has been performed DIL Diluent replacement LYS Lysis replacement Cleaner replacement DATE ACN Autocleanning cycle SCH Bleach cycle CAL Calibration QC 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 STE and under it the number of analysis run during this day Rio PRES 8 To print the log report press PIN ER H i to print the logs of the number of pages indicated on the To print the logs of one or more days select DAY then enter the day reference number sel allows to save the log file in an USB key 1 EIL TOOLS The recommended maintenances are described in a table section 9 1 1 5 10 ARCHIVE MYTHIC 22 CT can save more than the last 500 patients with results alarms distribution curves in the internal memory and until a maximum of 60000 results in a memory stick USB key of 512 Mbit or more see section 3 4 7 Press NE to enter the archive display Page 56 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 5 SAMPLE ANALYSIS 5 10 1 Results lt lt ID GAILLARD DATE PID R4857 4 11 84 SID 09903 16 84AM T A SELECTION S NB PAGES 36 ALL PID FRS67 S 11 84 SID 60420 18 1
30. i Then upwards raise the counting module the right side of the counting module 1 while pushing the top from the counting bath towards the inside of the Next remove the tubing fixed on the RBC counting head located on MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 89 99 9 SERVICE REF M22 UM EN 006 Remove the tubing fixed on the plastic fitting located under the stainless tube from WBC counting block Remove all connectors The counting bath module can now be handled to carry out the desired operations of replacement REASSEMBLY PROCEDURE To reassemble the unit carry out the various operations in the opposite direction Page 90 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 9 SERVICE 9 4 4 Baths o ring replacement Wear rubber gloves and wash hands with a disinfectant after completion of work Before performing the operation drain the baths and dismantle the counting bath block see section 9 4 3 Replace the o ring and or the complete bath block REASSEMBLY PROCEDURE To reassemble the unit carry out the various operations in the opposite direction Place the seal on the counting bath gently not to wound it 9 4 5 Aperture block replacement A Wear rubber gloves and wash hands with a disinfectant after completion of work
31. 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 anisocytosis RDW SD MCV Wintrobe constant calculation The Mean Corpuscular Hemoglobin MCH calculation is made from HGB and RBC by the formula below MCH HGB 10 RBC The Mean Corpuscular Hemoglobin Concentration MCHC is made from HGB and HCT by the formula below MCHC HGB 100 HCT Page 72 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 8 TECHNOLOGY 8 4 ANALYSIS OF PLATELETS Platelet analysis is made by impedancemetry in the RBC counting chamber at the same time with red blood cells Four parameters are obtained Parameters Pathologies adjustment section 3 4 4 1 PLT Platelets Thrombopenia PLT 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 measuring the Mean Platelet Volume MPV and the Platelet Distribution Width PDW Thrombocrit PCT is made from PLT and MPV by formula below PCT PLT MPV 10000 N 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 qu
32. 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 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 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 particulates 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 persisting symptoms Eyes Abundantly rinse opened eye during 15 minutes Skin Abundantly rinse during 15 minutes seek for medical advice in case of persisting symptoms Ingestion give large amount of w
33. section 3 4 4 1 THRESHOLDS Tress to adjust the parameters thresholds see section 3 4 4 2 eee to adjust the flags level see section 3 4 4 3 CORRECT FACTORS to adjust the corrections factors see section 3 4 4 4 NOTA No correction factors with type STANDARD RENAME TYPES To enter a new blood type press SSeS NOTA The name of the first type STANDARD cannot be change then TOOLS Press rons to print the blood type set up allow to print all the blood type set up about 20 pages are printed _PRINT SELECTED only the blood type in the combo box is printed MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 29 99 3 INSTRUMENT SET UP REF M22 UM EN 006 000 TYPE To rename a blood type press then select it then press Li to accede at the alphabetic keyboard then press veut to validate or Esc to exit without modification ro OD d 00 amp o 000 0 0 0 000 C C C C C C C 3 4 4 1 Limits PREUIDUS EDEN SCREEN MENU li 12 08 STRNDRRD This display enables to enter normal and panic limits for every 22 parameters given by the MYTHIC 22 see section 8 WBC RBC HGB HCT Meu MCH MCHC 28 8 RDW PLT MPU PCT PDW Ka N m n w oii oa oN e roll e ojojo To validate the new values press VALID key in the
34. the analysis are done with results of the Start Up outside the limits see section 5 4 Page 76 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 8 TECHNOLOGY 8 6 HYDRAULIC DESCRIPTION The hydraulic part of the MYTHIC 22 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 patent pending enables to draw the sample and to perform the WBC and RBC PLT dilutions It is assembled with a rotating rocker moving around a support which maintains the system to move up and down the sampling needle A very reliable system of rack gear moves the rocker The cleaning system of the sampling needle can be removed without tool see section 9 3 2 The o ring of the needle included in the cleaning system can also be removed without tool see section 9 3 2 The maintenance of these parts is very easy to perform 8 6 2 Counting bath module This module allows to count the WBC and RBC PLA and to measure the HGB It is made with a manifold maintaining the reagent commutation valves and the counting bath block with their measurement block including the apertures The counting bath block assembly and these apertures can be removed without tool see section 9 3 3 4 5 8 6 3 Syringes module This module two patents pending en
35. tolerances indicated on the blood control result sheet it is recommended to perform a calibration see section 7 6 2 QC MYTHIC 22 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 QUALITY CONTROL to have access to the quality control START UP SHUT DOWN CRLIBRRTION QUALITY CONTROL RESULTS SET UP SERUICE OPERATOR LOG OUT RERGENTS LOGS RUN SAMPLE Quality control display presents the identification of the lots The last active lot is labeled with a dark dot on the left lot LOT To choose another lot press on the wished lot CHANGE I The key allows the modification of the MBKO1762 L CBC identification and the target values RESTORE The key allows restoring the data from a USB key RESULT The key allows To view the result table To perform quality control analysis CHANGE RESTORE RESULT TOOLS To print send or save the targets results and graphics press KH Page 60 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 6 QUALITY CONTROL TOOLS MENLI PREVIOUS LOTS nBXei581 N CBC 1762 L riBKe1762 L TOOLS MENU H tor neseiese vr Leem CREATED ON TARGETS LIMITS 15 06 04 BY BOB PREVIOUS SCREEN is se ZER456 NI
36. 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 preamp 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 stability HCT amp PLT Perform a Back flush and a Cleaning Cycle and then a Bleach cycle if unsuccessful Check the level bubble flow in the RBC bath during the run cycle Check the level bubble flow in the WBC bath during the first dilution HGB No 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 Flag INS_H Close the door Perform a new Start Up cycle Perform a new Start Up cycle Page 92 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 9 SERVICE 9 5 2 Other problems
37. v HGB v REC Eur report To calibrate one or more parameters e Select the parameter 000 e Press the key CALIBRATION Raa el 1 6 1 6 1 8 0 9 a 6 00 G 0 0 0 Ex s e8 0 0 0 0 WS Gol 0 0 0 0 0 0 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 122224 e modify the lot number press Rest e Select the field to be modified e Enter your new value with the numerical keyboard or with the alphabetical keyboard Iess EXPIRY CRERTED ON 18 12 83 BV BILL TARGETS LIMITS RBC HGB HCT PEL e Press to validate your modifications or the loading e Press e Press tomo to load the target and tolerances values and expiry date and lot number from a USB key 2 to leave the menu without modification VDU BRE GOING TO DELETE SSOCIATED R 3 SULTS Eeer e Any modification lot number date or target values involves the deletion of all the associated results always in memory ves MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 67 99 7 CALIBRATION REF M22 UM EN 006 Plug the USB key then Select the right lot then press K i co Co Go o o Co Go o Co n ico lu
38. when the release of the software is failed Choose another version or call your Orph e s representative Page 34 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 4 SPECIFICATIONS 4 SPECIFICATIONS 4 1 ANALYTICAL SPECIFICATIONS Throughput gt 45 samples hour Sample Volume 15 7 ul inside the needle the total volume could be upper in function of the blood remaining outside of the needle 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 10 mm 0 to 100 0 4 or 4 RBC 10 mm 0 1 to 8 0 07 or 3 H6B g dL 0 5 to 24 0 3 or 2 HCT 5 to 70 2 or 3 PLT 103 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 mm3 8 to 15 HCT 70 to 80 PLT 105 mm 2000 to 4 000 Repeatability Calculated with 20 runs of a fresh whole blood sample performed on a commercial MYTHIC 22 PARAMETERS CV RANGE WBC lt 2
39. 006 8 TECHNOLOGY 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 the white blood cell membrane to keep it in closed native state EOSINOPHILES ALL ge NEUTROPHILES BASOPHILES TT 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 maintaining 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 lt WBC b LYM Lymphocytes in percentage Lymphocytosis LYM gt LYM h amp LYM Lymphocytes in value Lymphopenia LYM LYM b amp
40. 2 2001 EN 61000 3 2 EN 61000 3 3 EN 61000 4 2 95 A1 98 A2 01 EN 61000 4 3 02 EN 61000 4 4 95 A1 01 EN 61000 4 5 A1 01 EN 61000 4 6 96 A1 01 EN 61000 4 11 94 A1 01 EN 55011 Class B EN 55022 Class B IEC 61010 1 2001 IEC 61010 2 081 2001 IEC 61010 2 101 2002 N A Name und Funktion Nom et fonction Nome e funzione Name and function Co Philippe Daire RA amp QA MYTHIC 22 REF M22 UM EN 006 TABLE OF CONTENTS READ THIS BEFORE USING THE EQUIPMENT 0 ccc cee cece cence e cence ee Ie e e n erre 3 1 INSTALLATION ilic so bete th dootesebeak ooet tior eta ue anced eats d TT NPACKING eebe 1 1 1 Introduction Ge na ae di o 1 1 2 Unpacking Procedure aura aaa RO RI OEA 12 11 3 5 aerea N I A ART 13 EE ee Oe dE 13 1 2 1 Installation place 1 2 2 Installation environment 1 3 ELECTRICAL CONNECTIONS ae Gs 12 1 3 1 Power supply block teet e ordei de Rue a Eh eee ERE dede 1 4 PRINTER CONNECTION sss ta tasto aaa lo Eeer 1 5 CONNECTION CHANGE AND PRIMING REAGENTS ie 15 TDL Connection ic aed edet o RETRO ER CAT HER e C Qi GRE ia I ao 15 El EE 16 1 6 TRANSPORTATION AND STORAGE ees ee 18 23 GENERAL OVERVIEW xl LE RI cate eR rea rrUOU e E Ve nia 19 ZA GENERALITIES ddp Ree dn ade Ne RIRs ede o Ideen aded ag aet ee eR 19 2 2 OVERVIEW ds sae
41. 5AM NW PREVIOUS SCREEN YEAR 200 2001 2001 2002 2002 2002 2002 2002 2003 2003 2003 2003 2003 31 11 93 INTERNAL MEMORY The Archive display allows viewing the results of the analysis The first column presents the name of the different parameters the first line the result number The results of the patients are presented in column At the bottom of the display under the table the ID PID SID SEQ number date and time of the selected patient dark background are presented for each result selected The button lt gt located under the table allows changing pages To find a result in the list select the SEQ number wanted press To view an entire result select the SEQ number wanted press VIEW TOOLS To print send delete or save in an USB key results press ORTE allows to accede to the results date list It is possible to print send delete or save in a USB key All results Press NB PAGES 36 for printing Selected results Select the first and the last results CG seq aFROM essa to Then press Dum IEEE or NOTA the printed report is a list of all selected patients This prompt appears to confirm the storage in the USB key VOU ARE ABOUT TO If you press YES the selected results will be deleted from the internal memory and stored in the USB key This prompt al
42. 6 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 22 Copyright Orph e SA All Rights Reserved Page 25 99 3 INSTRUMENT SET UP REF M22 UM EN 006 If this window appears it means that several results in memory have not been sent before the MYTHIC 22 was switched off Press YES to send them immediately or press LATER to wait at another time or NO if you do not want to send them No USB key is available connect an USB key then press YES or see section 3 4 7 SOME RESULTS HAVE BEEN i ROME RESULTS HAVE to change the archive mode EXTERNAL STORAGE DEVICE DO YOU WANT THESE FILES TO BE MOVED ONTO IT 3 2 SYSTEM STATUS aL Press on the date and hour to have access to the system status window Different system status information is displayed SERIAL NUMBER OPERATOR ACCESS SETUP VERSION SOFT VERSION a To return to the MAIN MENU press BOARD tt To change the screen luminosity press L N or H LUMINOSITY Page 26 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 3 INSTRUMENT SET UP 3 3 SET UP 005 mage DATE amp TIME ns From the MAIN MENU press on SSS This menu is available for all users The DATE amp TIME windo
43. 6 5 1 0 to 4 5 Monocytes 10 pL 0 4 to 3 1 0 05 to 1 1 O to 0 8 O to 0 8 O to 0 8 0 2 to 10 6 12 M 4 5 to 5 8 RBC 10 yL 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 F 38t054 H 13 5 to 17 5 HGB g dL 14 5 to 22 5 10 to 16 105 to 135 105 to 13 5 11 5 to 14 5 F 125t0155 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 to 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 PREVIOUS soia SCREEN 2 THRESHOLDS STANDARD The threshold display enables to modify the detection thresholds located on the WBC scattergram and RBC PLT curves see section 8 WBC Li LEE 51118 asa DIF FLAGS 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 aas 869 126 2 607 ESC INIT DEF wgl TY DIF To accede for modification to the scatter gram threshold press orl and to the flags threshold press i Once modif
44. C 22 REF M22 UM EN 006 2 GENERAL OVERVIEW 2 GENERAL OVERVIEW 2 1 GENERALITIES MYTHIC 22 is a fully automated analyzer performing hematological analysis on whole blood collected on EDTA K2 or tubes Sample volume 15 7 pl inside the needle the total volume could be upper in function of the blood remaining outside of the needle Throughput gt 45 samples hour 22 analysis parameters DIF mode and 12 parameters in CBC mode Leukocyte parameters WBC LYM MON NEU EOS BAS White Blood Cells Lymphocytes in A DIF mode only Monocytes in amp DIF mode only Neutrophils in amp DIF mode only Eosinophils in amp DIF mode only Basophiles in amp DIF mode only Erythrocyte parameters RBC HGB HCT MCV MCH MCHC RDW Red Blood Cells Hemoglobin Hematocrit Mean Corpuscular Volume Mean Corpuscular Hemoglobin Mean Corpuscular Hemoglobin Concentration Red Blood cells Distribution Width Thrombocyte parameters PLT MPV PDW PCT Platelet Mean Platelet Volume Platelet Distribution Width Thrombocrit For Investigation Use only in the United States of America MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 19 99 2 GENERAL OVERVIEW REF M22 UM EN 006 2 2 OVERVIEW MYTHIC 22 consists of 8 main parts 1 Display Keyboard 2 Dilution hydraulic part 3 Mono electronic board 4 Reagent tray 5 Connection
45. 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 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 5 SAMPLE ANALYSIS 5 SAMPLE ANALYSIS 5 1 VERIFICATIONS BEFORE STARTING Before starting MYTHIC 22 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 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 MYTHIC 22 performs a home position checking for the three motors Th
46. EAGENTS 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 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 minutes 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 disposal legislation If any doubt call an emergency center MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 39 99 4 SPECIFICATIONS REF M22 UM EN 006 4 3 2 Lytic rea
47. ECIFICATIONS REF M22 UM EN 006 Parameter Specimen action P Possible Indication of Error on MYTHIC 22 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 pes 2190 and MT HCT values The limitations listed for Hgb and HCT values interferences M may cause indirect interferences The ROW is determined according to RBC count See RBC count RDW 2 The limitations listed for RBC may cause indirect interferences interferences Cause Clumped platelets may cause a decreased Seen tor latest aggregates on Smear Platelet Aggregation platelet count The specimen should be PLT Indication aggregates may be detected on the Severe Microcytosis Megalocytic Platelets RBC agglutination Hemolysis WBC scattergram with 1 amp or 2 amp or L1 amp or HL flags 4PIt TMPV Cause in case of severe microcytosis microcytes and schizocytes are below the RBC inferior threshold and may be counted with Platelets and cause an erroneously high Plt count Indication VRBC 1PIt 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 and are not counted Indication VPIt TMPV P2 flag
48. EH T please contact your Orph e s representative STRRTUP 12 SHUT DOWN 11 H MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 17 99 1 INSTALLATION REF M22 UM EN 006 DILUENT PRIME RERGENTS From the MAIN MENU press eem then DILUENT to have access to this screen r DILUENT LOT BUS EUM Enter lot number the expiry date and the container capacity CAPACITY ml 19000 CHRNGE RERGENT Press to validate the new entry or after changing a new container with the same information CHANGE REAGENT After the replacement a new container or to prime the diluent press PRIMEC DIVENT PRIME DILUENT KS ES Em A new entry is automatically done in the logs see section 5 9 LYSE AND CLEANER PRIME Proceed as described above for the diluent iE EM Enter only the capacity of the container CRPRCITV ml 9500 0 Hui After replacement of the waste container press RESET to reset to initialize the waste calculation 1 6 TRANSPORTATION AND STORAGE Storage temperature 10 C to 50 C If the MYTHIC 22 has been stored at a temperature less than 10 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 legislation Page 18 99 Copyright Orph e SA All Rights Reserved MYTHI
49. KER BUSY NUMBER MAX OF FILES REACHED PLEASE DELETE FILES PRINTER DRIVER UPDATE FAILED THE CHOSEN DRIVER IS NOT COMPATIBLE WITH THE MYTHIC 22 SYSTEM PRINTER ERROR PRINTER NO PAPER RS232 INTERNAL ERROR RUNNING AUTO CLEANING START UP CYCLE NOT DONE SVM COM TIME OUT SVM UNMATCH Re start the Mythic Re start the Mythic Perform a pistons greasing Call an Orph e representative Call an Orph e representative 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 Re start the Mythic Re start the Mythic Press The samples be run Perform a start up cycle Update the SVM software Re start the SVM Re enter the file or confirm it manual connection on the SVM Westgard alarm XB alarm Re start the Mythic Room temperature out of the limits lt 18 or 34 C Replace the bottle and perform a prime Cleaner Perform an initialization or a control cycle Re start the Mythic Perform a control cycle Switch on the printer or invalidate the printings Delete some files Modify the value Select the correct version Switch on the printer or invalidate the printings Switch on the printer or invalidate the printings Perform a clean cycle
50. OS clump overlapping NEU clump NH Flag _ ause hyper segmented or giant Neutrophils may Seek atypical Neutrophils Atypical overlap EOS clump RARA 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 Cali 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 increas RBC Cold Agglutinin NOV Cid ane increase Seek for red cell clumping Indication MCV VACT Cause in very rare case of severe microcytosis size evere Microcytosis of microcytes may fall below the minimum eek for microcytes on 5 Microcytosi C f microcy y fall bel he mini RBC Seek f icrocy threshold Smear Indication RBC TPlt R1 amp or flags Cause in case of macrocytosis size of macrocytes Macrocytosis may overcome the maximum RBC counting zone Indication YRBC TMCV R2 flag Cause agglutinated RBC may cause a low inaccurate Seek for clumped RBC on RBC agglutination RBC count Smear Indication abnormal MCH and MCHC values Fragmented RBC Cause BES copi zor ytes Seek for schizocytes on and interfere with RBC counting enean Indication RBC TPlt TMPV P2 flag c a level of WBC may cause an erroneous Centrifuge the sampl
51. Page 97 99 9 SERVICE REF M22 UM EN 006 9 8 HYDRAULIC DIAGRAM The length and inner diameters of the tubing shown on the diagram below the tubing table must be strictly respected when replaced otherwise there is a significant risk in the quality of results given E E E a E e E E 3 E 9 S 5 amp A Li x E El o o a x 31 N N po b N B 3 amp Designation Tubing 5 210mm Tubing 6 130mm Tubing 8 80mm Tubing 12 60mm Tubing 13 250mm Tubing 14 250mm Tubing 17 80mm Tubing 18 80mm Tubing 22 200mm Tubing 23 DILUENT 1500mm Tubing 24 WASTE 1500mm Tubing 25 55mm 45 Tubing 26 5mm Tubing 3 135 20 mm Tubing 9 40mm Tubing 10 500mm 2 X 10mm Tubing 30 130mm 5mm Tubing 31 80mm 5mm Tubing 32 510mm Tubing 33 240mm Tubing 34 270mm Tubing 35 130mm Tubing 36 230mm Tubing 37 190mm Tubing 38 180mm Tubing 39 180mm Tubing 40 960mm Tubing 41 200mm Tubing 42 180mm 2x5mm Tubing 43 250mm 3 x 15mm 2x5mm Tubing 44 270mm Tubing 45 100mm Tubing 46 400mm Tubing 47 240mm 3x15 mm 2x5mm Tubing 48 150mm 5mm Tubing 49 70mm Tubing 50 100mm 2 x 20 mm 5mm Tubing 51 180mm Tubing 52 50mm Tubing 53 60mm Tubing 54 365mm Tubing 55 140mm 15mm Tubing
52. S REF M22 UM EN 006 Reagent Consumption ml Software Version gt V2 2 0 005 CYCLES DILUENT LYSE CLEANER Run Sample DIF 21 0 0 96 0 45 CBC 13 10 0 73 0 45 Rinse All 11 0 Back flush 11 0 0 30 Control 14 7 0 50 All 39 20 5 6 5 60 Reagent Lysis OnlyOne 5 7 6 5 Prime Diluent 31 0 Cleaner 5 6 Cleaning 12 7 0 2 5 6 Bleach 46 0 14 0 45 Start Up 49 6 3 2 0 45 Shut Down 0 5 23 0 Latex WBC 14 5 1 10 0 45 Latex RBC 7 10 Latex OPT 1 13 00 0 9 Latex OPT 2 13 00 0 9 Latex OPT 3 13 00 0 9 Optical Led 1 00 0 10 Consumption with one run sample add one or two run sample consumption if needed POWER SUPPLY BLOCK Dimensions Height Width Depth Weight Power supply Input PRINTER LX 300 Dimensions Height Width Depth Weight Power supply Electric consumption Paper size Printer Speed 55 mm 127 mm 230 mm 1 32Kg 100 to 240VAC 2A 230VAC at maximum load 4A 115VAC at maximum load 50 60Hz 164 mm approx 366 mm approx 275 mm approx 4 4 kg approx Model 120V Model 220 240V 99 to 132Vac 198 to 264Vac 50 to 60 Hz 23W approx Depends on the format chosen in the set up Impact 9 needles Up to 300 cps character per second Copyright Orph e SA All Rights Reserved Page 38 99 MYTHIC 22 REF M22 UM EN 006 4 SPECIFICATIONS 4 3 R
53. TART 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 Page 74 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 8 TECHNOLOGY 8 5 3 Leucocytes Flags SCATTERGRAM FLAGS NL Ic All the followings flags levels are adjustable in the 20 types of blood see section 3 4 4 Number of cells in a zone N1 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 These flags may appear if the blood was not store in good conditions or if it was sampled too much more than 10 times 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 o
54. Unit Normal Limits Result Flags Unit Normal Limits WBC 5 7 Deg 4 0 12 8 WBC 5 8 De 4 0 12 8 Lt 48 2 n 25 0 50 0 MONZ 11 3 h H 2 0 18 8 NEUZ 42 8 L H 50 0 80 0 EOS 5 6 H 0 0 5 0 BASA g 7 0 0 2 0 RBC 5 14 19 6 1 4 00 6 20 W 15 4 gdl 11 0 17 0 RBC 2 100621 2 46 3 35 0 55 0 HGB Pere En 1 00 50 00 Meu 90 0 be 80 0 100 0 15 3 3 11 0 17 8 MCH HCT 2 2 H 29 9 pg 26 0 34 0 46 4 35 0 55 0 HCH 7 7 MCU n 8 33 2 g dl 31 6 35 5 98 6 80 0 100 0 RDU 2 2 5 30 08 SH 26 0 84 0 13 2 18 8 16 0 33 1 a 31 0 35 5 PLT 301 19 3 1 159 400 RDW D 7 13 2 gt 10 0 16 0 wu 84 Ke 24 4 18 PLT ses 10 1 15 400 PCT 9 243 H 0 200 6 500 MPU 8 1 m s 7 0 11 8 12 7 H 18 0 18 0 PCT 8 248 H 0 200 0 500 POW 12 0 z 10 0 18 0 FLAGS MONOCYTOSIS NEUTROPENIA MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 55 99 5 SAMPLE ANALYSIS REF M22 UM EN 006 5 9 LOGS From the main menu press to reach the logs display E MYTHIC 22 manage a simplified log allowing saving and displaying all the events done for the following actions Login with the Biologist code Login with the service Technician code STC Login with the Super service Technician code An intervention or maintenance has been performed 50 Start Up cycle has been performed SUF Start Up cycle has failed SDN Shut down cycle
55. VANCED SET UP TOOL m 04 This menu is reserved to biologist see section 3 1 Any modification can affect the quality of the results We recommend modifying these values only after an Orph e s training Please refer below for the description of each key 3 4 1 Printer set up ii E E e PRINT MI NORMAL LIMITS V PATHOLOGIES Printer set up menu is intended to present the printing report To select an option on the report press on the corresponding case JV HEADER v FLAGS KR comments V cURVES v UNITS To enter a header press Li key To exit the menu either press Esc to keep the last setting or to save the last modifications AUTO PRINT M ANALYSIS v ac v STARTUP HERDER ORPHEE MEDICAL Presentation Results MYTHIC 18 3 4 2 Communication eg E COM MODE HOST SERIAL HOST NET SUM SERIAL NONE Reserved for technical Service people To set up the connection between MYTHIC and Host TRANSMIT MYTHIC NUMBER HANDSHAKE DELAY ms Page 28 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 3 INSTRUMENT SET UP 3 4 3 Analysis options OPTIONS ALWAYS ID Us MODE ALWAYS PID ABSOLUTE DIF STARTUP ALARMS 7 ALARMS UNITS STANDARD BAR CODE READER PID C ID C SID BOLD DISPLAY f t D DIL
56. X Motor screw greasing X Reagents level control see section 5 3 Start up see section 5 2 Automatic Cleaning The cleaning is automatically performed by the MYTHIC 22 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 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 NOTA Maintenance information s are registered in a log see section 5 9 Page 80 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 9 SERVICE 9 1 2 Concentrate cleaning This cleaning is necessary once a week to clean the WBC and RBC baths or when MYTHIC 22 is in permanent rejection for one measured parameter or if it give too much clog flags see section 8 5 1 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 times with 36 MENU Return to the main menu by pressing Then press Press Hm ANA to start the cycle drain the counting chamber
57. a normal sample of the day before before beginning the series NOTA The MYTHIC 22 CT is delivered with a standard parameter setting described in section 3 MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 49 99 5 SAMPLE ANALYSIS REF M22 UM EN 006 5 6 2 Sample Identification RUN SAMPLE From the main menu press to reach START UP 1 the analysis display CALIBRATION QUALITY CONTROL SEET TS ANGST This prompt appears when the results memory FULL RESULT is almost full To avoid this message select the option FIFO mode in the set up SET UP SERUICE OPERATOR LOG OUT REAGENTS LOGS RUN SAMPLE BACKUP NO MEMORY AVAILABLE This prompt appears when the results memory is totally full To delete results see section 5 10 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 NOTA SID number is already done See section 3 3 Press E to accede to the blood type and alphabetic characters Press or or to change the measurement mode IDENTIFICATION PROCEDURE sin To enter or modify identification place the cursor in the selected field Typ
58. ables 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 driving the different reagent toward the counting bath module or toward the optical bench It maintain seven commutation valves MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 77 99 8 TECHNOLOGY REF M22 UM EN 006 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 These three keys are always present in all s
59. acturer s declaration Electromagnetic emmissions The MYTHIC 22 is intended for use in the electromagnetic environment specified below The customer or the user of the MYTHIC 22 should assure that it is used in such an environment Emmissions test Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Compliance level Class A Complies Electromagnetic environment guidance The MYTHIC 22 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 is intended for use in the electromagnetic environment specified below The customer or the user of the MYTHIC 22 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
60. ality of the results All of these flags appear on the right of the result measure or on blood smear d In presence of one or more flags it is recommended to check the result by a conventional NOTA Most of these 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 It 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 HCT 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 MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 73 99 8 TECHNOLOGY REF M22 UM EN 006 8 5 2 Instrument Flags W CL Suspicion of WBC aperture clog if it persists runs a concentrated cleaning see section 9 1 2 R CL Suspicion of RBC aperture clog if it persists runs a concentrated cleaning see section 9 1 2 O CL Suspicion of Optical injector clog if it persists runs a 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 run a S
61. ater 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 Copyright Orph e SA All Rights Reserved Page 41 99 4 SPECIFICATIONS REF M22 UM EN 006 4 4 ANALYTICAL LIMITATIONS 4 4 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 4 2 Interferences Parameter Specimen Occurrence Possible Indication of Error on MYTHIC 22 action WBC Cold Agglutinin Nucleated RBC Erythroblastosis Unlysed RBC Cryoglobulins Platelet aggregation Cause high IgM level may lower RBC and increase MCV
62. comes red the tube can be removed only when the needle up Start cycle A new cycle can be started again when it turns by again green trigger PREVIOUS TOOL MENU www cosce AS Soon as the cycle is launched the SID is incremented automatically and thanks to its data processing multitasks the MYTHIC 22 is available for the identification of the following sample See section 5 6 2 DOC DO H mmzaxrz mell Gol EE 00000 c 00000 co co c 000000 90900 0000000 RBC HGB HCT MEU MCH HCH RDW PLT MPY PCT PDW DOO SID TYPE STANDARD MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 51 99 5 SAMPLE ANALYSIS REF M22 UM EN 006 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 NOTA It is not necessary to wait for the end of the result printing to launch a new analysis The results are sent to the selected unit See section 3 The information located on the right of each parameter corresponds to the indicators for out of range limits and for the rejections see section 3 The scattergram and curves of distribution of each cellular population are located on the right screen Under the results a zone FLAGS is reserved for analytical alarms see section 8 5 At the bottom of the screen there are the three inlet fields
63. creen allows to come back to the previous display aT allows to come back to the MENU display where ever you are in the arborescence TOOLS depends on the screen it allows to open a window dedicated to perform an action for example to select information to print send or delete it Windows CYCLE VALVE 1 FAILED NG RESULTS THE PRINTER ORIVER HP PP PEEN UPLOADED Means an ERROR WARNING You have to INFORMATION window occurred it is mandatory confirm or not the action to do the action describe describe in the window in the window or in the table section 9 6 8 8 2 Menu tree See next page Page 78 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 8 TECHNOLOGY USER TREE VIEW VERSION 2 2 0 MYTHIC 22 OT CT Sasi haba ar J RSL START UP y O Launch Mechanical action SHUT DOWN End of day Cycle View Results CT menu not available in OT Mode 2L CHANGE RESU Target values entry CHANGE RESTORE RESULT oTHerviat Target values entry Retrieve OH QC Runs for checking _ciose USE levey Jennings Graphs RESULTS View chert results View NEL Vieve full screen _ View by dBteBnd by device 0 Web Interne memory Mass storage STBRINTERURBATE S 2 COMMUNICATION 7A RE 7 GTMERS 7 e Ce
64. dry blood particles inside the control tube To run quality control analysis EZ il o Present the control blood under the sampling needle o Press the start cycle trigger The cycle LED m located at the top of the needle flickers alternatively of red with green when it becomes red the tube can be removed 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 mm m The cursor AL allows displaying results for the other parameters VEC REC HSE CI i13 3 s 4e6 18 3 48 8 488 98 QC LOT MBX61 H CBC g 2 6 05 6 2 0 8 s il The window 8 8 6 90 6 80 1 50 1 60 1 memory for another blood control lot The column SEL allows to validate or to unselect a result e ala 0 ada E EAR 4 ba el om A allows access to the results in TOOLS To print send delete or save in an USB key a result press LoT nBxe1640 H CBC m wee IHG HET PLT rici 9 0 a ee a a 0 0 al a o o a a al a c el a ala ala al aol a Press to open the Levey Jennings graph screen Page 62 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 6 QUALITY CONTROL 6 2 3 Levey Jennings
65. e and LeuKocytosis C Indication very high 100 000 uL erer RE RBC 1MCHC pari Instrument count is affected by an increase in the result Instrument count is affected by a decrease in the result 2 Instrument count is affected by either an increase or decrease in the result which is sample dependent Page 44 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 4 SPECIFICATIONS Parameter Specimen action Possible Indication of Error on MYTHIC 22 Centrifuge the sample Leukocytosis 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 100 000 uL TMCHC use reference spectrophotometric method Cause in case of high level of lipids in blood will give NE wd Use reference manual hyperlipidemia the plasma a milky appearance that causes methods and a plasma blank inaccurate Hgb measurement to determine Hob Indication plasma appearance TMCHC 3 Cause in case of high level or abnormal of Abnormal Protein proteins in blood will give the lysed sample a Use reference manual hyperproteinemia cleudy appearance that causes inaccurate Hgb methods and a plasma blank hyperbilirubinemia measurement to determine Hgb Indication lysed sample appearance TMCHC Cause high IgM le
66. e connection on FSC Board Call an Orph e representative check your enclosure sensor check your reagent sensor Wait for the system to reach its temperature Switch on the printer or invalidate the printings Re start the Mythic Re start the Mythic Select other lot Replace the bottle and perform a prime Lysis results Delete results Delete the Q C results of the ongoing lot Re start the Mythic Perform a rinse cycle Rebuild cycles with good options Communication error retry Try to send the file again If the problem still occurs call an Wait before performing a cycle Close the door in case of emergency stop run a control cycle Run Startup Cycle If the problem still occurs call an Orph e representative Perform an initialization or a control cycle Replace the container and perform a prime Diluent check if your temperature fan is running Call an Orph e representative Re start the Mythic Enter an ID and or PID and SID Re start the Mythic Wait before performing a cycle If persisting re start the Mythic The files format are not ovailable for the Mythic Perform an initialization or a control cycle Perform an initialization or a control cycle Page 94 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 9 SERVICE MESSAGE ACTION MECA HOME SYRINGE NOT FOUND MECA MOTOR ROC
67. e cycle LED m turns red None cycle can be 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 Copyright Orph e SA All Rights Reserved Page 47 99 5 SAMPLE ANALYSIS REF M22 UM EN 006 5 3 REAGENT REPLACEMENT 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 12 AUTONOMY DIF run 12 Page 48 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 5 SAMPLE ANALYSIS 5 4 START UP RINSING START UP SHUT DOWN START UP To rinse the system before analysis press sse CRLIBRRTION QUALITY CONTROL RESULTS The cycle LED BI turns red None cycle can be performed before it turns green SET UP SERVICE Mythic will perform 1 to 3 empty cycles to check the carry over level This operator Los our level should not to exceed the following ratios WBC 0 5 RERGENTS Logs RBC 01 RUN SAMPLE HGB 0 5 PLT 10 If the level i
68. e fstanoaro 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 af lt lt To accede to another character page press or TYPE STANDARD To change the blood type press the combo box and select the type To valid the entry and return to the previous screen press Lm To return to the previous screen without validation press Page 50 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 5 SAMPLE ANALYSIS 5 6 3 Sample run Wear rubber gloves and wash hands with a disinfectant after completion of work NOTA The needle will be available as soon as the working temperature is reached about 15 minutes at 23 of room temperature PLEASE WALT O ESS 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 soon as the temperature is reached a measurement cycle be run ca x If the needle is not visible first presses the start cycle trigger and wait for the descent Present the tube of the blood sample under the needle and press the start cycle trigger The cycle LED located at the top of the needle be
69. ed 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 Stock No 004 000 00345 4 Pursuant to Part 15 21 of the FCC Rules chanaes or modifications to this equipment not expressly approved by C2 The symbol 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 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 Orph e KONFORMITATSERKLARUNG DECLARATION DE CONFORMITE DECLARATION OF CONFORMITY DICHIARAZIONE DI CONFORMITA Name und Adresse der Firma Orph e S A Nom et adresse de l entreprise 19 Chemin du Champ des Filles Nome e indirizzo della ditta Name and address of the firm 1228 Plan Les Ouates Wir erkl ren in al
70. elative 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 Copyright Orph e SA All Rights Reserved Page 13 99 1 INSTALLATION REF M22 UM EN 006 Please contact Orph e s representative if you want to use the instrument in special conditions height higher than 2000 m or special power supply conditions 1 3 ELECTRICAL CONNECTIONS All the connectors are in the rear of the MYTHIC 22 CONNECTION SYMBOL 2 USB ports section 3 4 7 ec Ethernet connection TCP IP External barcode reader RS232C Host connection RS232C Printer connection Centronics E Je Power supply cord connection 24V Equipotentiality Si Any output or input connections except the printer and the bar code reader supplied by ORPHEE cannot be done without the ORPHEE representative authorization 1 3 1 Power supply block MYTHIC 22 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 and if possible in an u
71. ey To run repeatability press first seme MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 63 99 6 QUALITY CONTROL REF M22 UM EN 006 PREUIOUS EN TOOLS l MENU 1 The key eme allows having access to the repeatability display This screen allows carrying out a test of repeatability on all the parameters ii measured by the MYTHIC 22 SEL Prec HG LHET PLI icf 6 10 61 143 21 3381 Present the sample under the sampling needle and press in the trigger LEE EE located behind the needle 15 7 5 55 14 56 486 5 315 ER 50 The cycle LED located at the top of the needle flickers alternatively of red with green when it becomes red the tube can be removed EE Repeat the operation as many times as desired maximum 20 runs Pesi The results are progressively sent line in the table er Sab Statistical calculations are automatically carried out with each run DIS gt The cursor located between the two tables enables to send the other results the results of statistical calculations move at the same time 620 wec TeecC HGB lucy PLT i1s 5 97 19 8 48 9 ses amp i The column SEL J allows to validate or to unselect a result 8 3 8 13 8 2 8 4 s a EH 2 3 1 1 6 0 70 2 47 TOOLS The key SEE allows carrying out the following actions o Print the table o Send the res
72. for the identification of the next sample See section 5 6 2 TIRI XIIIIIOD ont EH KEN A 510 STANDARD 1 2 2 n Tye staNDARO Example of an abnormal result analysis in DIF mode with flags located at the right of the results and in the flag box under the result DO ST Vj DOMO lt D o MOCZIO SIMANA It is mandatory to read the section 8 5 to understand the flags meaning 14 12 2 TYPE STANDARD we N A Example of a normal result analysis in CBC mode 4 52 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 5 SAMPLE ANALYSIS 05411 10 15 TYPE STANDARD DO TS now DOMO lt D O PREZZO OO wm EE S T 816718 EB EIN E i a 5 Press on the matrix to access to a zoomed view Press on the flags zone to open the flags window In regard of the different flags found by the MYTHIC 22 the upper 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 Press on flag region to access detailed flags window The lower part describes the machine problem see section 8 5 2 TOOLS Press to reprint or to resend the result To print the result press To send the resul
73. g 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 adds the tubing straw adaptor supplied with the installation kit Connect the waste tube female connector on the outlet on the top and tighten the cap on an empty container Do not modify the type and the length of the diluent and waste tubes The diluent must be placed at the same level as the MYTHIC 22 It is mandatory to collect the waste in a container and treat it in compliance with your local legislation MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 15 99 1 INSTALLATION REF M22 UM EN 006 1 5 2 Priming When first starting the MYTHIC 22 it is necessary to perform a complete prime of the fluidic circuit The reagents must be stored 24 hours minimum at room temperature before use A Before starting be sure that all the reagent and waste tubes are properly connected Priming procedure INFORMATION SYSTEM UPDATE SHOULD NOT EXCEED 3 LOGIN PASSWORD A z ENGLISH AUTONOMY CBC run 12 AUTONOMY DIF run 12 D switch on Connect the power supply block Press the ON OFF button The cycle LED turns red No cycle can be performed before it turns green The information w
74. gent 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 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 haemoglobin 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 minutes Skin Abundantly rinse during 15 minutes 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 measure Person related safety precautions Wear protective equipment
75. ications are done press to validate or to exit without any modification Press cer to return to the manufacturer parameter setting 5 DIFF THRESHOLDS RAW DATA NiX 05 HIV aaa WBC Mat D N2x bbb N2Y bbb LYN a HON LNLX 1000 LNLY NEU EOS a LMNX 808 LMNY BAS 000 LNEY 000 Eosv 599 cL E ALL L a LMX DD NH L a NH H a ICK DI RNEY NL L a NL H NMY RL L 8 BX1 900 BY1 PL a ope e ex leoo eve Threshold modifications can affect the quality of the results exa ooo eva 598 uec or affect the alarm detection area We recommend to eee Cee 8 8 modify these values only after an Orph e s training 0 0 0 0 6 8 BAS 8 0 INIT DEF Press Lr oer to return to the manufacturer parameter setting ESC TEST INIT DEF MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 31 99 3 INSTRUMENT SET UP REF M22 UM EN 006 5 DIFF THRESHOLDS Raw DATA Mix EEE nv 666 w o da A P N a NH L 600 666 NH H IA NL L a 00 666 NL H a RL L a 666 RLR RL R HE L a aaa HLH aaa HL H Threshold modifications can affect the qualit
76. indow could stay up to 3 mn to enable the update of all the files Login The operator s identification display appears Enter the user s identification the password see section 3 1 and press _ to validate AUTONOMY run indicates the number of samples runs you can perform calculated with the smaller quantity of reagents If this window appears it means that several results in memory have not been sent before the Si uae men PE MYTHIC 22 was switched off GE Press YES to send them immediately or press LATER to wait at another time or NO if you do not want to send them No USB key is available connect an USB key then press YES or see section 3 4 7 to change the archive mode Page 16 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 1 INSTALLATION MENU system priming The main menu is displayed Press on NOTA To do an emergency stop push shortly on the switch on off button Press The MYTHIC 22 performs a complete priming cycle The cycle LED BI turns red No cycle can 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 EL TL to visualize the cycle counters RE MER To reset the counter with the button NEN NEN DIF RUNS fot H
77. ing In DELAY box the user can modify o Time in minutes to start the automatic shut down DELAY ms o Time in minutes to buildup the needle bes E o The setting up of the automatic cleaning M VALID AUTOCLEAN and its frequency in number of analysis CLEAN FREQUENCY Run Nb o The setting up of the automatic wake up M VALID WAKE UP and its daily time WAKE UP TIME Reagent checking enables the reagent control see section 1 5 2 Pressure Checking is accessible for technician only Eee enables to modify the biologist password V VALID AUTOCLEAN CLEAN FREQUENCY Run Nb sa VALID WAKE UP WAKE UP TIME 80 90 DATE FORMAT foo v AM PM MODE BIOLOGIST PASSWORD REAGENT CHECKING v PRESSURE CHECKING DD HM vVy DATE FORMAT enables to select the date format AM PM mode enables to display the format of time of your choice Once modifications are done press to validate or ESC_ to exit without any modification 3 4 7 Storage options PREVIOUS ans MEN Case MYTHIC 22 can save more than the last 1000 patients with results alarms distribution curves in the internal memory and until a maximum of 60 000 F FIFO Hone results ina memory stick USB key of 512 Mbit or more m All the capacity until 2 Gbit maximum can be used REAL TIME RUNS SAVE Because the technology of the USB key is very different fro
78. k 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 Copyright Orph e SA All Rights Reserved Page 43 99 4 SPECIFICATIONS REF M22 UM EN 006 Parameter Specimen action Possible Indication of Error on MYTHIC 22 Cause Toxic or abnormal granules as much as EOS Brahulstons degranulated areas may alter optical properties of Seek for Granulations ft A modifications eosinophils and cause an erroneous EOS counting modifications on smear Indication diffuse downwards spreading E
79. le RF communications equipment should be used no closer to any part of the MYTHIC 22 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms d 1 2 P IEC 61000 4 6 150Khz to 80Mhz Radiated RF 3 Vrms d 1 2 P 80MHz to 800MHz IEC 61000 4 3 80Mhz to 2 5Ghz d 2 34P 800MHz to 2 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 by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Kp 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
80. leiniger Verantwortung dass Nous d clarons sous notre propre responsabilit que Dichiariamo sotto nostra responsabilit che We declare under our sole responsibility that das Medizinprodukt f r die In vitro Diagnostik le dispositif m dical de diagnostic in vitro Mythic 22 il dispositivo medico diagnostico in vitro the in vitro diagnostic medical device Ref M220T 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 entsprich
81. lows following the storage MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 57 99 5 SAMPLE ANALYSIS REF M22 UM EN 006 5 10 2 View MENU Keys 03 10 SEIL stANDARO identification allow displaying each result and its ce a TOOLS To print send or delete a result press The effects of the TOOLS key are as described in section 5 10 1 The printed report is full page with one or two results per page quien DOMO lt D O Deo cmomzzrz oue S z OO Kr CIT c ANON come back to the archive main page press MENU E SEET WWAN BIEN m To come back to the Main Menu press 1 eus em BE It is possible to print or send i ALL SEQ sFROM To All results Press m NB PRGES 36 for printing Selected results Select the first and the last results RESULT seq aFROM 2538 Then press Lett esee cl This message appears when you exit the result screens and it could stay up to 6 mn to IN EILE SYETE UPDATE enable the update of all the files MN ULD NOT EXCEED 6 Page 58 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 5 SAMPLE ANALYSIS 5 11 STAND BY AND SHUT DOWN NOTA It is recommended to switch off the MYTHIC 22 if it is not
82. m one to the other 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 USB key Choose REAL TIME RUNS SAVE to directly save sample run onto USB key If USB key is available result will be store at the end of the sample run MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 33 99 3 INSTRUMENT SET UP REF M22 UM EN 006 Press wee DRIVE FORMAT to format USB key The system will format the USB Key and build specific directories for Mythic management This prompt appears if none USB key is available Press yes if you agree to format the USB key It is mandatory to format the USB key on the Mythic before to use it 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 TOOLS MENU VERSION RELEASE LORD Uara aa2 Press to load a new software version from a USB key Choose the right version then Press yes only if you are sure to load new version software The current software version will be erased definitively This prompt appears to confirm the version loading This prompt appears
83. mythic 22 User s Manual SA 19 chemin du Champ des Filles 1228 CH Plan Les Ouates SWITZERLAND Tel 41 0 22 706 18 40 Fax 41 0 22 794 43 91 Web Site www orphee medical com Cod M22 UM EN 006 REF M22 UM EN 006 REVISIONS 01 HC 16 11 05 gt V1 0 Creation 02 27 03 06 OM HC gt V1 0 0 008 Sections 3 4 6 4 2 5 6 3 9 8 modified 03 25 10 06 HC SH gt V 1 1 0 Sections 3 4 4 5 7 8 5 9 6 9 1 1 modified 04 03 05 07 HC gt V 2 0 0 Management of USB key sections 3 3 5 10 6 2 7 2 05 HC CM gt V2 2 0 Add flags information section 8 5 5 8 5 6 Modify QC amp CALIBRATION Update Hydraulic diagram and tubing list Update of Installation Kit 07 12 09 Update of Maintenance Kit Update Hydraulic diagram and tubing list 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 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 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 operatio
84. n 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 other hazards gt Check that the voltage setting matches the supply voltage gt Protective earthing is required plug the MYTHIC 22 into a supply outlet which has an earth connection Preserve a good access to the supply outlet to be able to unplug the MYTHIC 22 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 gt Do not use the MYTHIC 22 if it is not working properly or if it has suffered any damage damage to the supply cord or its plug damaged caused by dropping the power supply adapter Do not let the power supply adapter or its flexible cord come into contact with surfaces which are too hot to touch Do not place anything on top of the MYTHIC 22 Do not use the MYTHIC 22 where aerosol sprays are being used or where oxygen is being administred c Do not use the MYTHIC 22 out of doors gt Always switch off the MYTHIC 22 and disconnect the power adaptor before dismantling any part gt The MYTHIC 22 is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories by an authorized people Only human blood o
85. n smear Basophile result must be checked on smear if it is following by a star XXX MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 75 99 8 TECHNOLOGY REF M22 UM EN 006 WBC CURVE FLAGS This curve is done by the WBC channel measurement and does not appear on the normal results screen The flags L1 and L5 complete the flags N2 and IC cui 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 3 Erythrocyte and HGB Flags R1 Abnormal quantity of microcytes at the left side of CR1 R2 Abnormal quantity of macrocytes at the right side of CR2 HGB means bad measure of the HGB blank dl KZ 8 5 4 Platelet Flags P1 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 8 5 5 QC Flags QC_F QC Failed means that the results are outside the limits entered for one or several parameters see section 6 2 1 QC_ND QC Not Done means that the Quality Control has not been done or that the analysis are done with QC results outside the limits see section 6 2 1 8 5 6 STARTUP Flags SU_F STARTUP Failed means that the results are outside the limits for one or several parameters see section 5 4 SU ND STARTUP not done means that the Start Up has not been done or that
86. next page see below S PE 80 0 26 0 31 0 KA n e ole DIER pol AH pol ro Zu oll Al alal S UE He Halal eee e T e x n e A e e o o co ta Hrs HO colo m o Sun ce PREUIOUS SCREEN TOOLS MENU 4 L L h H LYM vaL e e J r Once modifications are done press to validate or to exit NEU SC 2 8 8 0 2 0 A ops EOS without any modification BAS 15 6 1 0 NEU 45 0 50 0 85 0 eosa sasz 2 0 Press INIT STD to return to the parameter setting of the lt standard type Page 30 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 3 INSTRUMENT SET UP Example of reference values from LABORATOIRE D HEMATOLOGIE DU C H U D ANGERS FRANCE First week Hays doc 2 manta 1 3 to 6 years 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 15 to 8 5 15 to 8 5 1 8 to 8 0 1 8 to 7 5 Eosinophils 10 yL 0 2 to 0 85 0 2 to 1 2 0 05 100 7 0 02 to 0 65 O to 0 6 0 04 to 0 8 Basophils 10 yL 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 20 to 8 0 15 to
87. pper position to avoid the contact with any liquid To disconnect electrically the MYTHIC 22 remove the power supply plug from the main circuit In the case of replacement of the main power wire supplied with the MYTHIC 22 the new f one must comply with the local regulation 3X 1 5mm cable and 250V 10A plug The MYTHIC 22 has been certified with the power supply box provided with the machine The use of another external power supply box is not guaranteed Please contact your Orph e s representative 1 4 PRINTER CONNECTION Connect the printer cable in conformity with the printer user s manual Use the parallel rear plug of the MYTHIC 22 A or the USB plug e to connect the printer cable Select the printer driver section 3 3 Page 14 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 1 INSTALLATION 1 5 CONNECTION CHANGE AND PRIMING REAGENTS MYTHIC 22 works with the reagents described in section 4 3 Some commercial reagents can also be used Please contact your Orph e s representative 1 5 1 Connection Lysis reagent and cleaning solution Before handling the reagents read carefully their specifications described in section 4 3 Remove the door on the left side of the instrument Put the reagent bottles in the dedicated location Remove the caps of the bottles Tighten the red caps on the Lyse bottle red sticker and the blue one on the cleanin
88. r artificial control blood should be run Only the reagents mentioned in this manual are permitted to use The optimum performances can be only achieved if the cleaning and maintenance procedures are carefully followed Due to the use of this equipment all parts and surfaces of the MYTHIC 22 are potentially infective Wearing rubber gloves is highly recommended and after completion of work wash hands with disinfectant gt Always replace or use parts of the equipment by parts supplied by ORPHEE distributor gt 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 gt The treatment of waste and the elimination of a part or the complete instrument must be done in compliance with the local legislation c Any output or input connections except the printer and the barcode reader supplied by ORPHEE cannot be done without the ORPHEE representative authorization Do not open the door located on the right side of the instrument see section 1 1 3 when an hydraulic cycle is in progress for it would lead to an immediate stop To re start shut the door and run a Control cycle see section 9 3 1 KEEP THESE INSTRUCTIONS MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 3 99 REF M22 UM EN 006 This equipment needs special precautions regarding general requirements for safety Guidance and manuf
89. ring replacement EE 91 9 4 5 Aperture block e E 91 9 5 TROUBLESHOOTING 9 5 1 Analytical problems 9 5 2 Other problems ies E 79 d 9 6 TROUBLESHOOTING MES SAGE e e e o 93 9 LOGS ERRORS een bre ila 9 8 HYDRAULIC DIAGRAM MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 11 99 1 INSTALLATION REF M22 UM EN 006 1 INSTALLATION 1 1 UNPACKING 1 1 1 Introduction The MYTHIC 22 is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories by an authorized people Only human blood or artificial control blood should be run Only the reagents mentioned in this manual are permitted to use The optimum performances can be only achieved if the cleaning and maintenance procedures are carefully followed If the MYTHIC 22 has been stored at a temperature less than 10 C it must be left at room temperature during 24 hours It must be calibrated at each displacement and installation See section 7 1 1 2 Unpacking Procedure Before unpacking the instrument we recommend to check the box of the instrument and notify any damage to the carrier Open the box on the top remove the starter kit Remove the MYTHIC 22 from the box Starter kit contents INSTALLATION KIT Designation Tubing DILUENT Tubing WASTE 150W switching adapter European Power line cord MYTHIC 22 User manual MYTHIC 22 Installation Report MYTHIC 22 Q
90. rogressively sent on line in the table Repeat the operation as many times as desired maximum 10 runs Statistical calculations are carried out automatically with each run CALIB LOT C9224 CALIBRATION The window og Lor ees located between the results and the came Lor es statistical calculation reminds the lot number of the calibrator The column SEL allows to validate to unselect a result COEF 1 9 1 4 1 6 1 0 1 8 CALIBRATION ES To calibrate press or 6 0 0 00 6 0 6 0 6 6 0 00 0 0 8 6 6 6 6 6 2 01 6 6 Before to run the calibrator check and clean the opening of the cover dedicated to the down of the needle to avoid any fall of dry blood particles inside the calibrator tube NOTA The results of the analyses carried out on one calibrator during the same day remain with the screen and are used in calculations if they are selected Page 66 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 7 CALIBRATION 7 1 2 Calibration Before to start the calibration unselect the results which you do not wish to use for the calculation of the calibration See below section 7 1 1 CALIBRATION The key DO mon or allows e To calibrate with the selected results DELETE RLL e To delete the results Press SEDE GEL e To print the results Press ELE see below the print v wec
91. rved MYTHIC 22 REF M22 UM EN 006 9 SERVICE 9 7 LOGS ERRORS PREVIOUS aE E EM mum From the MAIN MENU press Then press aeos PRENIOUS TOOLS menu aile oc 20 51 079 INTERN RESU a _ ech TOM ES SE ST suet This screen allows visualizing the date and timing when an error has 05706 12 27 981 BACKUP SYST ini i eae EE UST occurred as well as the code and the origin of this error 706 04 03 083 BACKUP SYST 5 12 21 SYST h h h kei 03786 20 39 085 BACKUP SVST iai i ENS bon t the error press on i e ocated on the left of 1217026 84 15 687 BRCKUP SVST SE E ee the date the complete error appears at the bottom 63 06 20 51 889 BACKUP SYST 24706 4 09 090 BACKUP SYST 85796 12 27 091 BACKUP SVST 06706 29 45 092 BRCKUP SVST To pri nt it press 87786 04 03 893 HARDWARE SV 98796 12 21 994 HARDUARE SV 59796 29 39 995 HARDUARE SV 19796 64 57 696 HARDWARE SV e HARDWARE SYSTEM ERROR TOOLS PREVIOUS MENU E 04 SELECTION PAGES 5 C ERR FROM TO Select to print the errors of the number of pages indicated on the Screen To print or save in an USB key the error of one or more days select ERR FROM TU then enter the error reference number INTERN COUNT ERROR MYTHIC 22 Copyright Orph e SA All Rights Reserved
92. s higher MYTHIC 22 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 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 with more flags up to 48 hours after the blood draw and only 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 minutes during 10 minutes The results and the flags could be affected in case of too much sampling more than 10 times l A volume of insufficient blood for the quantity of anticoagulant or a bad mixing may involve an erroneous result 5 6 ANALYSIS 5 6 1 Introduction 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 at a room temperature gt 23 see 5 6 3 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 If the quality control is not carried out it is recommended to perform two analyses on
93. t die anwendbar sind remplit toutes les exigences de la directive relative aux dispositifs m dicaux de diagnostic in vitro 98 79 CE qui le concernent soddisfa tutte le disposizioni della direttiva relativa ai dispositivi medico diagnostici in vitro 98 79 CE che lo riguardano meets all the provisions of the directive on in vitro diagnostic medical devices 98 79 EC which apply to it MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 7 99 Angewandte Gemeinsame Technische Spezifikationen harmonisierte Normen nationale Normen oder andere normative Dokumente Sp cifications techniques communes normes harmonis es normes nationales et autres documents normatifs appliqu s Specifiche tecniche comuni norme armonizzate o nazionali applicate altri documenti normativi applicati Applied common technical specifications harmonised standards national standards or other normative documents Konformitatsbewertungsverfahren Proc dure d valuation de la conformit Procedimentodi valutazionedellaconformita Conformity assessment procedure Konformitatsbewertungsstelle falls beigezogen Organe respons de l valuat de la conformit si consult Organo incaric della valutaz della conform se consultato Notified Body if consulted Ort Datum Lieu date Luogo data Place date Gen ve le 06 Juin 2008 Page 8 99 Copyright Orph e SA All Rights Reserved REF M22 UM EN 006 IEC 60601 1
94. t press Ls A EXIT To close the window press MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 53 99 5 SAMPLE ANALYSIS REF M22 UM EN 006 5 8 PRINTING Once the analysis is finished the MYTHIC 22 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 One result per page DIF mode CBC mode ORPHEE MEDICAL ORPHEE MEDICAL Presentation Results MYTHIC 22 Presentation Results MYTHIC 22 Name Patient Id Name Comments Sample Id 90017 Comments 90018 y STANDARD STANDARD Operator ID SAS Date 14 12 2005 11 25 56 Seq 00032 Operator ID SAS Date 14 12 2005 11 27 30 Seqt 00033 Result Flags Unit Normal Limits Result Flags Unit Normal Limits 5 7 WBC 5 8 10 3 1 4 0 12 0 48 2 11 3 h L RBC 10 671 HGB g dl LYM c e d MON e Bee NEU MCH pg Los MCHC CH BAS RDW H PLT 18 37l RBC MPU m s HCT PDW d MCU MCH GS MCHC FLAGS RDW PLT MPU PCT FLAGS MONOCYTOSIS NEUTROPENIA Comments Comments Page 54 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 5 SAMPLE ANALYSIS Two results per page DIF mode CBC mode 5 8 2 Model report
95. the location in which the MYTHIC 22 is used exceeds the applicable RF compliance level above the MYTHIC 22 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 gt Over the frequency range 150KHz to 80MHz field strengths should be less than 3V m MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 5 99 REF M22 UM EN 006 NOTE This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a 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 in a 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 on a circuit different from that to which the receiver is connect
96. uality Control Certificate Screwdriver Slot 1 4 e e e e e jeje MAINTENANCE KIT Designation Tygon tubing L 500mm 1 02mm Tygon tubing L 500mm 1 3mm Tygon tubing L 1000mm 1 52x3 2mm Tygon tubing L 500mm 2 06x4mm Tubing 10 Tubing 50 Cables Ties Rinsing Head O ring Silicon grease 3gr Short Arm TORX T10 Tool k lele leloa le 1 1 1 Short Arm TORX T20 Tool Page 12 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 1 INSTALLATION 1 1 3 Visual checking e Open the door on the right side with the key provided in the kit To be checked 1 Counting chambers perfectly locked in their manifold locations 2 Needle s dismountable system located in the rocker 3 Rocker in front 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 that the MYTHIC 22 fulfills its function place the instrument on a table which supports the weight of the instrument printer and reagents around 40 Kg Leave a space of 10 cm in the rear of the instrument to ensure a well ventilated place Avoid a place that can be exposed to direct sunlight 1 2 2 Installation environment Indoor use b Altitude up to 2 000 m c Temperature 18 C to 34 C d Maximum r
97. ults o Delete the results wee Lee HGB HET PLT rici 19 9 s 97 15 8 48 9 323 81 8 3 8 13 8 2 8 4 s a Cu 2 2 1 i 8 8 amp 7 2 47 6 Page 64 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 7 CALIBRATION 7 CALIBRATION The calibration of the MYTHIC 22 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 Before the launch of a calibration make sure that the analyzer is ready for use Do not hesitate to run a cleaning cycle followed by a STARTUP cycle The calibration blood must be used before its expiry date be mixed and stored in accordance with the instructions of use recommended by the manufacturer 1 CALIBRATION sur mom HI To reach the screen Calibration press the key mon CALIBRATION from the main menu QUALITY CONTROL RESULTS SET UP SERVICE OPERATOR LOG OUT REAGENTS Loss RUN SAMPLE This menu sends the following information LOT 5224 o Lot number of the last used calibrator e a o The expiry date of the current lot BY BOB o The last date of calibration deel The operator name si o The target values 16 5 o The current coefficients of calibration ui Se CHANGE Press to enter new values or to modify the values CHANGE NEN RESULT
98. use for several hours consecutives SHUT DOWN From the main menu press ME MYTHIC 22 automatically performs a shut down cycle __startue soroan All the hydraulic circuits are rinsed and then cleaned with the cleaning CALIBRATION solution ri At the end of the cycle MYTHIC 22 automatically stop Shut Down can be automatically performed after a setting time see EX ven 3 4 6 SET UP SERVICE NOTA After a shut down it is impossible to perform an analytical cycle ne without launching a start up cycle See section 5 2 REAGENTS LOGS RUN SAMPLE MYTHIC 22 must stay at rest with cleaning solution during three hours every 24 hours MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 59 99 6 QUALITY CONTROL REF M22 UM EN 006 6 QUALITY CONTROL 6 1 INTRODUCTION Quality control allows checking the stability of the MYTHIC 22 analytical performances when operating 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 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 a Cleaning cycle see section 9 1 2 followed by a STARTUP cycle If result still exceeding the
99. vel may lower RBC and increase 3 Cold Agglutinin C mev M cell clumping Indication MCV 4HCT Leukocytosis Elevation of WBC Cause in case of chemotherapy cytotoxic and Abnormal Red Cell C 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 Ses EE Spherocytosis smaller than normal RBC leading to a low HCT Sag 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 Megalocytic Platelets Leukocytosis Indication abnormal MCH and MCHC values Cause may cause a low inaccurate MCV value because of an excessive size Indication TMPV P2 flag Cause high level of WBC interferes with MCV determination Indication very high WBC gt 100 000 uL TMCHC methods to determine the accurate MCV value Seek for megalocytic platelets on Smear 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 Copyright Orph e SA All Rights Reserved Page 45 99 4 SP
100. w enables to modify the time and the date To select the language of the Mythic menu choose the right one in the LANGUAGE ENGLISH Language combo box PRINTER DATE LANGUAGE ISH e PRINTER Select the printer or no printing PRPER SIZE fu LETTER Select the paper size depending on the number of results per page PAPER SIZE 11 LETTER START DAY SID START DAY SID Two SID are available Start day SID enables to select the first SID for each new day ADVANCED CURRENT SID If you want to select a new SID number Esc PRINTER 3 UPDATE vao See section 3 4 ADVANCED n Biologist reserved for complete settings Once modifications are done press either Luc to valid or E to exit keeping the previous setting TOOLS to print save or load from an USB key all the set up Select the printer and its connection mode PRINTER PORT Then press LOAD Press ses then the driver is loaded in the MYTHIC 22 This prompt appears if the release is failed Check the USB connection or change the USB key or call your Orph e s representative This prompt appears if the THE PRINTER ORIVE HRS BEEN UPLORDED SUCCESSFULLY R HP6l22 release is done successfully MYTHIC 22 Copyright Orph e SA All Rights Reserved Page 27 99 3 INSTRUMENT SET UP REF M22 UM EN 006 3 4 AD
101. y of the results or can affect the alarm detection area We recommend to modify these values only after an Orph e s training to return to the manufacturer parameter setting FLAGS LEVEL TYPE 2 In the Alarm menu users can modify the sensitivity of the alarms for the different cells WBC RBC PLT and differential See section 8 5 Once modifications are done press NS to validate or Esc to exit without any modification Press type to return to the parameter setting of the standard 3 4 4 5 Correction factors 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 _ to validate or E without any modification to exit Page 32 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 3 INSTRUMENT SET UP 3 4 5 Calibration factor CALIBRATION FACTORS To accede at this menu press in the ADVANCED SET UP MENU see section 3 4 In this menu the user can modify the calibration factors without any calibration with calibration blood A M letter appears on the right of the date of calibration in case of modification The modification of any of these factors without running a calibration blood could affect the quality of the result 3 4 6 Other Sett
102. ytes Flags tere it die e ele he SEENEN 75 8 5 3 Erythrocyte and HGB Flags leale ale PU ead teed e hee RU MED ente aeta tacet 76 8 5 4 Platelet Flags alla EE Ed 76 85 9 QC Flags p 1 76 8 5 6 STARTUP FAQS iiss iiss ee eee Le Rte n d ede ARIA 76 8 6 HYDRAULIC DESCRIPTIONL ette e ili ii eil i la 77 8 6 Sampling mod le nsin nl ao REA AE RA RO AA RR 77 8 6 2 Couriting bath module eee eter ti pectet coperte eade posted esti adc 77 BIEN 77 8 6 4 Optical manifold ZI 77 8 6 b Optical bench i ERI Ae da ere aed ea AR a Ra 78 BiB SOFTWARE 78 RN Windows LORO lA 78 8 8 2 Menu TOS 78 9 55 80 ERE IT UVsm B 80 SLL Maintenance table sedie eee eee le e edle dee n Leet ir 80 9 1 2 Concentrate clearing uer oae aos eie ere e REOR ORO YER EORR UNTERE CR Tet 81 Page 10 99 Copyright Orph e SA All Rights Reserved MYTHIC 22 REF M22 UM EN 006 RE ET EE 9 2 Ke ere KENE DA REPAIRING 9 4 1 Emergency stop Se 9 4 2 Needle or o ring replocement iii 86 9 4 3 Baths dismantling ENEE 88 9 4 4 Baths o

Orphee Mythic 22 Hematology Analyzer

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