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Orphee Mythic 22-AL Hematology Analyzer

1. gta 6 2 2 control blood OIJ REPEATABILITY E CALIBRATION son SR OD UE Ted Sec Da AS OS T IRUN CAETBRA aKO I Desa ram re nte RE E RR DR SER RT RR RR RETE cr 7 11 Calibration blood analysis 5 eee ttes aiii Ie Ae ee ees eae nk vein tein ees arena 74 TL2 S Tor Dr het 74 7 2 TARGET VALUES MODIFICATIONS nn den e e ire ei eaten 75 TECHNOLOGY 5 eise Re Re A apes ee MuR irr CU D e et 8 1 DETECTION PRINCIPLES RT O e EXT 8 11 PLT Counting T A a ie 8 1 2 Five part diff measurement tette eie eee ARRAS eX RABAT ERE eoa AE nn 77 8 1 3 Hemoglobin meas rement dee rede e 78 8 2 LEU KOCY TE ANALY SES qs tote eei Re RR ASA Vete 78 82 1 scene nte as onde coda nov me ir Pon ted a OR en iR n e ER Cer e a rre REA dh e 78 8 2 2 Eocal blood controllimittatiotis oorr eire roster e RR E EAR AUR ABRE PRESE RM 79 8 3 ERYTHROCYTE ANALYSIS coo n e a OL a c c ON E DL Ebo c EL a E v ec 80 8 4 ANALYSIS OF PLATELETS 81 8 amp ed tre heave Nr een ee ee RIES BNE GEENA M 8 5 1 General Flags d D d Re 8 5 2 Instr mert Flags mee ne en OUI OI RO UR Ge EGRE aede re tete 82 OK REND eA HE 82 8 5 4 Erythrocyte and
2. This prompt allows follow up the storage This prompt informs that the storage has been unsuccessful try another USB key 5 10 2 View 4 0 SE TOOLS STATUS 16 04 19 39 Keys 1 and allow displaying each result and its identification To send print delete or save results press The printed report covers one full page with one or two results per page To come back to the archive main page press D PREVIOUS SCREEN To come back to the Main Menu press MENU MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 67 109 5 SAMPLE ANALYSIS REF M22AL UM EN 004 4 PREVIous SE TOOLS NB PAGES 14 FROM To STATUS 16 04 19 43 5 11 STAND BY AND SHUT DOWN 4 PREVIous SE START UP SHUT DOWN TOOLS STATUS QUALITY CONTROL CALIBRATION OP LOGOUT DISPLAY RUNS RESULTS 30 04 18 16 To send print delete or save results press TOOLS It is possible to send print delete or save All results Press FREE for printing Selected results select the first and the last results ces ji die numeric keyboard Then press on SEND PRINT and DELETE or SAVE To exit the prompt without action press EXIT SHUT DOHN From the main menu press SHUT DOWN MYTHIC 22 AL automatically performs a shut down cycle
3. RimseAl no 01 00 Bockflush Aperture 112 SysemInt 148 O0 04 Prime LysisOnyOne 57 66 ___ 40 1 demr 00 00 34 Latex RBC PLT 72 00 00 AdjOPTGCAL 130 10 Nate OP 10 00 Adjust LED 09 01 00 Startup o 32 0 Consumption with one run sample add one or two run sample DIF consumption if needed POWER SUPPLY BLOCK Dimensions Height 40 mm Width 70 mm Length 170 mm Weight 0 4Kg Power supply Input 90 to 260VAC 1A rms for 230VAC 2A rms for 115VAC Power supply output 24VDC 150W maximum output power PRINTER LX 300 optional Dimensions Height 164 mm approx Width 366 mm approx Depth 275 mm approx Weight 4 4 kg approx Power supply Model 120V Model 220 240V 99 to 132Vac 198 to 264Vac 50 to 60 Hz Electrical consumption 23W approx Paper size A4 Printer Impact 9 needles Speed Up to 300 cps character per second MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 41 109 4 SPECIFICATIONS REF M22AL UM EN 004 4 3 REAGENTS SPECIFICATIONS All the reagents must be stored at room temperature 18 C to 25 C 4 3 1 Diluent ORPHEE code number HM22 003 10 Opening shelf life 60 days Application The diluent is used to carry out the necessary dilutions for the measurement performe
4. 5 6 ANALYSIS 5 6 1 Introduction All the maintenance see section 9 1 must be done before running any samples or controls The quality of the results cannot be insured if the maintenance is not done It is recommended or mandatory according to the legislation to carry out a Quality Control QC and possibly a calibration before any analysis see section 6 amp 7 Read the analytical limitations see section 4 4 before running the sample The working temperature of the fluidic part must be reached before starting the analysis The average time to reach it is around 20 min at a room temperature gt 23 C If the quality control is not carried out before beginning the series it is recommended to perform two analyses on a normal sample the day before to check the results are closed to results obtained the day before NOTA The MYTHIC 22 AL is delivered with a standard parameter setting described in section 3 The samples can be run in two sampling modes Closed tube with the use of the racks see section 5 6 7 STAT with open tube or other vial only see section 5 6 8 5 6 2 Working rules General rules The analysis of a sample in RUN RACK or RUN NEEDLE mode can be run after all fluidics cycles except the SHUT DOWN after which a START UP is mandatory and DRAIN ALL after which a RINSE ALL is mandatory Sampler The setting rules of working of the rack system are defined in section 3 4 4 Sam
5. To print a part of or all the errors press REX NB PAGES 1 From To print or save on an USB key the errors select ALL for all the pages the number appears at the right or select ERR then the starting number and the ending number 9 4 REPAIRING After opening any doors or dismantle any parts for performing a cleaning or a repairing take attention with all metal sheets which can injure your fingers 9 4 1 Emergency stop 4 PREVious scREEN TOOLS STATUS 30 04 18 16 ae In case of mechanical or hydraulic problem immediately press the MYTHIC 22 AL will make an emergency stop QUALITY CONTROL O After having identified the problem see section 9 5 it is necessary to perform a system initialization by pressing SYSTEM INIT or accede to this cycle by pressing EE from the MAIN MENU WORKLIST DISPLAY RUNS m o SHUT DOWN CALIBRATION OP LOGOUT Page 94 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 9 SERVICE 4 Previous M TOOLS STATUS 01 05 11 18 To mE the Ea init E This cycle allows reinitializing all the motors unloads the racks which remain in the sampler clean and rinse all the fluidics part After this initialization the work may continue 9 4 2 Needle or o ring replacement Wear rubber gloves and wash hands with a disinfectant after completion of work The replac
6. 3 INSTRUMENT SET UP REF M22AL UM EN 004 3 4 6 5 Rename types PREVIOUS SCREEN TOOLS STATUS 23 02 15 15 VALID ESCAPE UNDO alo 3 4 3 Other Setting 04 08 15 58 VALID AUTOCLEAN VALID F THR F FRI SAT su UNDO REAGENT CHECKING PRESSURE CHECKING To validate or not the modification see section 8 7 1 3 4 1 Printer set up PREVIOUS SCREEN TOOLS STATUS 23 02 14 38 PRINT VALID F NORMAL LIMITS F PATHOLOGIES Iv HEADER FLAGS Iv COMMENTS F CURVES ESCAPE Iv UNITS UNDO AUTO PRINT Iv ANALYSIS F STARTUP To rename a blood type press then select the box to change and enter the name of the new type with the alphabetic keyboard To validate or not the modification see section 8 7 1 NOTA The name of the first STANDARD type cannot be changed In DELAY box the user can modify o Time in minutes to start the automatic shut down o Time in minutes to raise up the needle o The setting of the automatic cleaning Iv WALID AUTOCEEAN and its frequency in number of analysis o The setting of the of the automatic wake up M VALID WAKE UP and its daily time and the day of the week Reagent checking enables the reagent control see section 1 5 2 Pressure Checking is available for techni
7. 31 9 35 5 2 Ar woe PLT 1 190 3 1 150 400 J RDU 13 2 x 18 8 16 8 MPU 1 7 0 11 0 PLT 388 10 3 1 159 400 PCT 243 a 6 200 0 500 MPU 8 1 m 3 7 0 11 6 7 18 8 18 6 NY PCT 9 248 9 200 0 500 10 0 18 6 Xe FLAGS MONOCYTOSIS NEUTROPENIA MYTHIC 22 AL REF M22AL UM EN 004 5 SAMPLE ANALYSIS 5 9 LOGS INTERVENTIONS LOGS From the main menu press ES to reach the logs display MYTHIC 22 AL manages a simplified log allowing to save and display all the events performed each day for the following actions BIOLOGIST Login with the Biologist password 4 PREVIOUS SCREEN TOOLS MENU STATUS 04 08 16 44 TECHNICIAN Login with the service Technician password SUPERTEC Login with the Super service Technician INTERVENTION X password START UP PAIL i 7 5 INTERVENTION intervention or maintenance has SHUT DOWN mn x X DILUENT CHANGE x x X x uem been performed LYSIS CHANGE START UP Start Up cycle has been performed START UP FAIL Start Up cycle has failed DELETE RESULTS Ss X X X SHUT DOWN Shut down cycle has been performed DILUENT CHANGE Diluent replacement LYSIS CHANGE Lysis replacement CLEANER CHANGE Cleaner replacement AUTOCLEANING Auto cleaning cycle BLEACH Bleach cycle CALIBRATION Calibration QUALITY CONTROL Quality control DELETE RESULTS Results deleted in Archi
8. Page 28 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 3 INSTRUMENT SET UP 3 2 SYSTEM STATUS 4 PREVIous scrEEN TOOLS MENU STATUS 30 04 18 16 Press on the date and hour to have access to the system information window START UP QUALITY CONTROL DISPLAY RUNS SHUT DOWN CALIBRATION RESULTS OP LOGOUT Press on to have access to the status of the MYTHIC 22 AL Different information are displayed e Name of the operator LOGIN LEVEL SUPERTECH E RUNNING CYCLE e Level of acce NUMBER OF RACKS IN THE e Name of the cycle in progress CURRENT RACK IDENTIFICATION e Number of racks CURRENT TUBE USER FREDDY 3 3 SET UP From the MAIN MENU press on 4 PREVIOUS SCREEN TOOLS MENU STATUS 30 04 18 34 This menu is available for all users E The DATE amp TIME window enables to modify the time the TIME hh m d date and the day DUE gm EDS To select the language of the Mythic menu choose the right one in the LANGUAGE combo box EJB PRINTER Select the printer no printing PAPER SIZE Select the paper size per result ILE Two SID are available een START DAY SID enables to select the first SID for each new day CURRENT SID enables to fix the beginning of the current SID number which will be used in the AUTO SID number in the work list see section 5 6 2 ADVANCED PRN DRIVER Bio
9. 01 05 11 34 VALID LOGIN ESSEN Enter your login and password as described in section 3 1 AUTONOMY run indicates the number of samples runs e rM you can perform in CBC or DIF mode calculated with the smaller quantity of reagents To validate or not the modification see section 8 7 1 The following prompt appears when you switch on the instrument every day If you press YES the work list will be automatically cleared and the AUTOSID will be reset 5 3 REAGENT REPLACEMENT The reagents must be stored 24 hours minimum at room temperature before use Page 50 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 5 SAMPLE ANALYSIS 4 FEV screen TOOLS STATUS 30 04 18 16 START UP REAGENTS To check the level of each reagent press REAGENTS SHUT DOWN OP LOGOUT PREVIOUS SCREEN TOOLS STATUS 23 02 10 25 If one reagent or more 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 PRIME ALL CYCLES COUNTER 5 4 START UP RINSING To rinse the system before analysis press 4 PREVIOUS SCREEN TOOLS MENU STATUS 30 04 18 16 Mythic will perform 1 to 3 blank cycles to check the carry over level The level should not to exceed t
10. 5 SAMPLE ANALYSIS REF M22AL UM EN 004 5 6 3 Work list 4 PREVIous SE TOOLS MENU STATUS 30 04 18 16 START UP QUALITY CONTROL WORKLIST DISPLAY RUNS SHUT DOWN CALIBRATION RESULTS Press 114833 to access to the work list OP LOGOUT 4 Miu E TOOLS MENU STATUS 15 04 20 01 SID 20 ams SUE A The work list allows to follow the demographic data of each 08 GAILLARD sample to be run P0003 GAILLARD 599008 DUPONT The list can be filled out directly from the LIS see section 1 RITCHIE PA0008 PALADO 3 4 2 or manually P00006 GUILLOU Pone MAROT To enter the demographic data of a new sample press LRU see section 5 6 4 To modify an existing demographic data press see section 5 6 5 To display the full result in progress press see section 5 6 6 To run an emergency sample STAT press see section 5 6 8 RUN RACK ORDER ORDER DISPLAY RUN Meaning of the columns LS is the Type of rack see section 5 6 7 fl is the number of the Rack see section 5 6 7 is the Position of the tube inside the rack see section 5 6 7 is the Status of the samples To do T Done D In Progress P done but Unmatched U Other columns modifiable in the following sections Sample Identification MLD Patient Identification MDM Identification Type of test reques
11. 8 2 RBC 5 12 4 00 6 20 HGB 15 3 9j 11 0 17 0 HCT 46 4 A 35 0 55 6 Meu 90 6 mes 80 0 100 0 MCH 30 0 pg 26 0 34 0 MCHC 3 1 gdl 31 8 35 5 ROW 13 2 z 10 0 16 8 PLT 308 10 371 159 400 MPU 7 0 11 8 A PCT G 248 z 9 200 0 500 FN 12 9 z 19 8 18 8 aw FLAGS MONOCYTOSIS NEUTROPENIA Comments Mame Patient Id Comments Sample Id Type STANDARD Operator ID SAS Date 14 12 2005 11 27 30 Seat 00033 Result Flags Unit Normal Limits WBC 5 8 10 3 1 4 8 12 0 Un RBC 5 14 10 6 1 4 08 6 20 HGB 15 4 g dl 11 0 17 0 HCT 46 3 a 35 0 55 0 A MCU 20 0 n 3 90 0 180 0 MCH 9 9 pg 26 0 34 0 MCHC 33 2 gdl 91 0 35 5 ROW 13 2 10 0 16 0 PLT 301 10 3 1 isa 400 MPU 8 1 n 3 7 0 11 0 PCT 9 243 9 200 4 500 12 7 z 98 0 18 0 FLRGS Comments MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 63 109 5 SAMPLE ANALYSIS REF M22AL UM EN 004 DIF mode Two results per page CBC mode 5 8 1 PCL6 model report Name CARMONA Patient Id Comments Sample Id Birth Type Gender Test Coll Operator Tn oM Date Seas Result Flags Unit Normal limits WBC 8 7 18 3 l 4 0 12 0 35 8 ra 25 6 58 80 MON 10 7 h ra 2 8 10 0 NEUZ 49 3 50 0 88 80 050 4 1 6 9 5 0 BAS 8 1 z 0 0 2 0 LYM 3 10 3
12. All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 9 SERVICE Wear rubber gloves and wash hands with a disinfectant after completion of work Put bleach in a container Then introduce the tip to wet it Clean the top of the bath some traces of dried blood can remain with the tip until the complete removing of the durst IMPORTANT NOTICE Never enter the tip inside the bottom of the bath otherwise the counting electrode could be damaged and the results altered Put 3 ml of sodium hypochlorite solution in each counting chamber Close the door Press the button in the window located in the middle of the screen MYTHIC 22 AL performs a maintenance cycle of the apertures and the flow cell followed with a standby mode during 2 min After 2 min MYTHIC 22 AL rinses all of the elements Operator can perform an analytic cycle Wear rubber gloves and wash hands with a disinfectant after completion of work MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 89 109 9 SERVICE REF M22AL UM EN 004 9 1 3 Piston greasing 4 Miu E TOOLS 91 05 11 18 To have access to the hydraulic cycle press SERYICE from the MAIN MENU and then press BGR to put the piston of the syringe module in the greasing position Operators must be trained and should know that due to moving parts there is a risk to pinch t
13. D ANGERS FRANCE First week J Rene Yo 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 1 5 to 8 5 1 5 to 8 5 1 8 to 8 0 1 8 to 7 5 Eosinophils 10 uL 0 2 to 0 85 0 2 to 1 2 0 05 to 0 7 0 02 to 0 65 O to 0 6 0 04 to 0 8 Basophils 10 uL 0 to 0 64 O to 0 2 O to 0 2 O to 0 2 O to 0 2 O to 0 2 Lymphocytes 10 uL 2 0 to 11 0 2 0 to 11 0 4 0 to 10 5 2 0 to 8 0 15 to 6 5 10 to 4 5 Monocytes 10 uL 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 1 0 6 12 M 4 5 to 5 8 RBC 10 pL 10 L 5 0 to 6 0 3 8 4 8 3 6 to 5 2 44 to 5 3 40 to 5 4 F 3 8 t0 5 4 H 13 5 to 17 5 HGB g dL 14 5 to 22 5 10 to 16 105 to 13 5 105 to 13 5 11 5 to 14 5 F 12510155 S M 40 to 50 HCT 44 to 58 38 to 44 36 to 44 36 to 44 37 to 45 37 to 47 MCV fl 100 to 120 85 to 96 70 to 86 73 to 89 77 to 91 82 to 98 MCH pg 34 to 38 24 to 34 23 to 31 24 to 30 24 to 30 gt or 27 MCHC g dL 32 to 36 32 to 36 32 to 36 32 to 36 32 to 36 32 to 36 PLT 102 31 10 L 150 to 400 150 to 400 150 to 400 150 to 400 150 to 400 150 to 400 3 4 6 2 Thresholds PREVIOUS SCREEN TOOLS MENU STATUS 23 02 15 36 The threshold display enables to modify the detection VALID thresholds located on the WBC scattergram and RBC PLT curves see section 8 04
14. Data processing External barcode reader To avoid all deterioration risks only the field service engineer may touch this electronic board 2 4 3 Power Supply Block MYTHIC 22 AL is supplied with an external power supply block In case of replacement of the main power wire supplied with the MYTHIC 22 AL the new one must be in compliance with the local regulations The MYTHIC 22 AL has been certified with the power supply box provided with the machine If another power supply is used with the instrument Orphee or its representative will not apply any warranty on this power supply and on the instrument Please contact Orphee or its local representative before using such material Page 26 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 2 GENERAL OVERVIEW 2 4 4 Reagent tray The reagent tray is dedicated to the OnlyOne lysing reagent and cleaning solution bottles 2 4 5 Sampler gli This module enables to load transfer mix and unload the racks Ten racks of five tubes can be loaded The loading can be done continually The rack are loaded on the guide rail by a loading screw then displaced by another screw transfer screw The rail which maintains the rack can also rotated for mixing the blood inside the tubes When all the samplings are performed for a rack it is unloaded by the unloading motor MYTHIC 22 AL Copyright Orphee
15. 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 a decrease in the result which is sample dependent Page 46 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 4 SPECIFICATIONS Parameter Specimen action P Possible Indication of Error on MYTHIC 22 AL Cause Toxic or abnormal granules as much as EOS Granulations degranulated areas may alter optical properties of Seek for Granulations amp modifications eosinophils and cause an erroneous EOS counting modifications on smear Indication diffuse downwards spreading EOS clump overlapping N
16. 1 1 0 75 6 MON 10 3 1 8 1 1 8 NEU 4 18 3 l 2 0 8 8 EOS 190 3 1 0 9 7 0 4 BAS 190 3 1 6 8 0 2 REC 4 46 18 6 1 4 00 7 6 20 HGB 13 5 g dl 11 8 17 8 HCT 42 2 4 35 0 55 8 MCU 94 6 ft 80 0 100 0 MCH 30 3 pg 26 9 34 0 MCHC 32 8 g dl 31 8 7 35 5 RDW 12 2 18 8 16 8 PLT 264 190 3 1 159 400 MPU 8 7 fl 7 8 11 0 L1RLNiN 2355488 49 deno Page 64 109 MONOCYTOSIS NEUTROPENIA ATYPICAL LYMPHOCYTES ERYTHROBLASTS PLATELET AGGREGATES Copyright Orphee SA All Rights Reserved ORPHEE MEDICAL ORPHEE MEDICAL Presentation Results MYTHIC 22 Presentation Results MYTHIC 22 Name Patient Id Patient Id Comments Sample Id 88017 Comments Sample Id 00018 STANDARD Type STANDARD perator ID SAS Date 14 12 2005 11 25 56 Seqt 00032 Operator ID SAS Date 14 12 2005 11 27 39 Seqt 00033 Result Flaas Unit Normal limits Result Flaas Unit Normal limits WBC 5 7 10 341 4 0 12 0 WBC 5 8 10 341 4 8 12 0 LYM 40 2 25 0 50 0 MONA 11 3 h a 2 0 18 80 NEUZ 42 8 L 50 0 80 0 EUS 5 8 2 9 9 5 0 BAS g 7 x 0 0 2 0 RBC 14 10 671 4 00 6 20 HGB 4 gdl 11 0 17 0 C 6 HCT 3 35 0 55 0 RBC 5 12 10 6 1 4 00 6 28 9 5 HGB 15 3 gdl 11 0 17 8 MCU n 3 80 6 100 0 de 1 f MCH 19 pg 34 0 46 4 d 95 0 55 0 MCHC 2 dl 9 MCU 30 6 n 3 80 0 100 0 2 8 35 5 h 30 0 pa 26 0 34 0 2 16 8 MCHC
17. 5 or 2 PLT 103 mm 40 or 7 MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 39 109 4 SPECIFICATIONS REF M22AL UM EN 004 4 2 PHYSICAL SPECIFICATIONS General Ambient temperature from 18 to 34 C Relative Humidity 80 maximum at 31 C Storage temperature 10 to 50 C Altitude up to 3 000 m If the MYTHIC 22 AL has been stored at a temperature lower than 10 C it should stay at room temperature during 24 hours before being switched on INSTRUMENT Dimensions Height 410 mm approx Width 500mm approx Depth 430 mm approx Weight 25 kg approx Power supply Input 24V 6 25A DC Electrical consumption During cycle 60 W 10 Stand By 25 W 10 Maximum 130 W 10 Display TFT Color LCD 8 4 640 480 Mode landscape Retro lighted Barcode optional Barcode reader C39 Barcode 2 interleaved 5 Memory capacity 1500 Files Demographics results and histograms in the internal memory gt 50 000 results in a memory stick USB key of 512 Mbit or more until 8 Gb QC 12 levels 200 Files per level Connection RS 232C Ethernet TCP IP USB Page 40 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 4 SPECIFICATIONS Reagent Consumption ml Software Version gt V1 0 Run Sample 227 10 O6 o 147 06 DIF Stat 222 10 06 pC stot 144 06
18. 6 1 ON FLAGS see section 3 4 6 3 ON CLOGS the rerun will be done when one or several parameters are clogged SAMPLER AUTO STOP Conditions of sampler stop After 3 consecutive clogs on the same parameter After 3 consecutive flags on the same parameter SAMPLER The sampler will draw only the blood with a CDB REPEATABILITY Enter a number to fix the number of sampling done in the repeatability test in RUN RACK mode see section 6 3 To validate or not the modification see section 8 7 1 OPTIONS box ALWAYS ID and ALWAYS PID To run a sample it is mandatory for the user to enter a ID and or a PID RUO With tag the PCT and PDW parameters are displayed printed and sent US MODE The Research Use Only message is printed under the printing report ABSOLUTE DIFF With tag absolute values for sub populations of leucocytes are displayed In the other case percentages are displayed QC ALARMS The message QC failed appear under the printing report when the QC result is out of tolerance or expired the message QC not done appear under the printing report when it is not run UNITS EDI Gives a choice of three unit systems Standard International System and mmol BOLD DISPLAY box display and print in bold faced type the different choices in this box To validate or not the modification see section 8 7 1 Page 30 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM
19. All the hydraulic circuits are rinsed and then cleaned with the cleaning solution At the end of the cycle MYTHIC 22 AL automatically Stops Shut Down can be automatically performed after a setting time see section 3 4 6 NOTA After a shut down it is impossible to perform an analytical cycle without launching a start up cycle see section 5 2 MYTHIC 22 AL must stay at rest with cleaning solution during three hours every 24 hours or replaced by a bleach cleaning done each day instead of each week see section 9 1 2 Page 68 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 6 QUALITY CONTROL 6 QUALITY CONTROL 6 1 INTRODUCTION Quality control allows checking the stability of the MYTHIC 22 AL analytical performances when operating Orphee recommends using the following controls Myt 5D tri level code number MYT502 Myt 5D Normal level code number MYT506 The control blood must be used before its expiry date and stored according to the manufacturer s instructions for use It must be well mixed before use according to the instructions for use In case of no specific local regulations it is recommended to run a control blood at the beginning of each working day before running sample In case of exceeding the tolerances indicated on the blood control result sheet it is recommended to perform a calibration see section 7 In
20. E 31 3 4 3 Other Setting 34 3 41 3 41 3 4 2 Calibrationif actor eee ied loei tbe edet bete ao edel t eti pert ee do toes bet coa ed unn 36 34 3 E STORAGE OPTION SE onse nn 36 3 44 Version release on tee te e ted ed d Eee E 37 4 4SPECIFICATIONS Dd RR BE oe pew eR cote entries Be ite duc DER anne 38 41 ANALYTICAL SPECIFICATIONS A t v eet oe te debet e e A n THERE TAE Pe Edge 38 4 2 PHYSICAL SPECIFICATIONG 4 3 REAGENTS SPECIFICATIONS d Jis s AL sise en ie 4 3 2 Lytic reagent OnlyOne 4 3 3 CCIE ANALYTICAL EIMETATIONS be Rede b v ETC CE RE V DNE dei Ee e D t dee eee 4 41 Recommendations at d d i der 24 2 ENTER TE eedem MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 11 109 5 REF M22AL UM EN 004 SAMPLE ANALYSES PE Di cius ocean Pio a cie e 5 1 VERIFICATIONS BEFORE STARTING T 2 Y T aM ario ant RER nn ne tn de A M M RE 53x REAGENT REPLACEMENT UE ne Mn du ne ne MEUM er STARTUP RINSING en O een EE etre ie 5 5 PREPARATIONS BEFORE ANALYSIS wu sccsssssssssssssesscsscsssessessessssscsucsucsucsussssssssssscsucsucsucsucssssssssssssussucsucsuc
21. EN 004 3 INSTRUMENT SET UP 3 4 2 Lab parameters PREVIOUS SCREEN TOOLS STATUS 23 02 14 45 Select the blood pe in the combo box TYPE STANDARD then press LIMITS DT s PTS to adjust the normal and panic limits see section 3 4 4 1 THRESHOLDS LIMITS to adjust the parameters THRESHOLDS thresholds see section 3 4 4 2 FLAGS LEVEL rice dre to adjust the flags level CORRECT FACTORS see section 3 4 4 3 RENAME TYPES COS dnos to adjust the correction factors see section 3 4 4 4 NOTA No correction factors with type STANDARD To enter a new blood type press RENAME TYPES NOTA The name of the first STANDARD type cannot be changed TOOLS Press to print the blood type set up PRINT allows to print all the blood type set up about 20 pages are printed EXIT to leave the prompt without action 3 4 6 1 Limits PREVIOUS SCREEN Fas Em E This display enables to enter normal and panic limits for every 22 parameters performed by the MYTHIC 22 AL see VALID H section 8 ESCAPE The limits are those of the type displayed above the table UNDO To validate or not the modification see section 8 7 1 Press to return to the parameter setting of the standard type MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 31 109 3 INSTRUMENT SET UP REF M22AL UM EN 004 Example of reference values from LABORATOIRE D HEMATOLOGIE DU C H U
22. HGB Flags ro tti ER DR REO pe e titel peut ederent een nee ec 83 8 5 5 Platelet Flags sine RNA n e te IO e REP RON EG POR Nina il deemed e 83 8 56 Got ol 3 6 cM 83 BDF STARTUP feo a RE en ee ent en ee lent nee 83 8 6 HybRAULIC amp MECHANIC DESCRIPTION onerati pea indio tea i e an d p ra a ERGUN 84 8 6 1 Auto loader module s E As Le 8 62 Sampling mod le RR e e e RR 8 6 3 COUNTING 84 8 6 4 Syringes module cease e eere eo IR ER HT ne nan ARREST nn nana ennui 84 8 6 9 Optical manifold rr eee i Te d 84 Page 12 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 9 8 6 6 Optical bench eti ee ment nel R dr tr Ne ein 85 Acro uni ARE EI 85 8 741 Common F nctionalities d eee tete ee etd co eo i dete ade b a deoa be ea YS CMKH RE ERR 85 8 7 2 Menu tree SERVICE m SRM MAINTENANCE 9 11 Maintenance table 9 12 Concentrate cleaning 9 3 Piston greasing SEE O EE eH OLA Inline filter cleaning eene ite h eae Ee ee eee een ebd eene bea dee eL essaie 9 15 Barcode cleaning 9 2 CLEANING 9 3 TROUBLESH
23. MCHC is made from HGB and HCT by the formula below MCHC HGB 100 HCT Page 80 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 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 EN 8 5 FLAGS MYTHIC 22 AL manages 25 different flags These flags allow the user to be warned if there is a problem which may affect the quality of the results All of these flags appear on the right of the result In presence of one or more flags it is recommended to check the result by a conventional measure or on blood smear 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 can appear with WBC RBC PLT and HGB see section 8 5 3 for HGB an
24. PREVIOUS SCREEN RERUN is only available when the sample become Done D Enter the demographic data of the new patient with the keyboard To validate or not the modification see section 8 7 1 To run this patient in STAT mode or open vial mode press see section 5 6 8 To come back to the work list press il PREYIOUS SCREEN RERUN is only available when the sample become Done D This screen allows displaying the last result in progress and its demographic data At each analysis the screen is updated with the last result To run this patient in STAT mode or open vial mode press SSeS scc section 5 6 8 To come back to the work list press MUS PREVIOUS SCREEN To stop the racks in progress to run a emergency sample or for any other reason press STOP RACK The movement of the rack stops then the fluidics stops To re launch the rack press Meisel then The analyze re start at the last sample Page 55 109 5 SAMPLE ANALYSIS REF M22AL UM EN 004 5 6 7 Run Rack 5 6 7 1 Preparation before loading Wear rubber gloves and wash hands with a disinfectant after completion of work Never use a rack with a non dedicated sample tube the needle may be destroyed and the results may be erroneous See the authorized tubes in section 5 5 2 If no rack exists for a special vial please refer to the section 5 6 8 to run it The lab
25. SA All Rights Reserved Page 27 109 3 INSTRUMENT SET UP REF M22AL UM EN 004 3 INSTRUMENT SET UP 3 1 USER S IDENTIFICATION 3 1 1 Start Up Machine UI ER MM MM EMEN LEE After the instruments initialization the identification window is displayed m OGIN FREDDY EUR In the window the last eso operator s identification appears Either the identification is yours press PASSWORD 1 and enter your password or the NUN identification is not enter your login with the keyboard PROS MENGE The window enables to change the language To validate or not the modification see section 8 7 1 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 AL 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 6 3 1 2 In process 4 Miu E TOOLS MENU STATUS 30 04 18 16 To change operator during the process press EE OP LOGOUT START UP return to the main menu and then press on rs To change identification proceed as described above section 3 1 1 WORKLIST DISPLAY RUNS CALIBRATION RESULTS SHUT DOWN OP LOGOUT
26. ULM EP deem D E the table allow changing pages 20 gz demo PRESCRIPTOR ESC TYPE To find a result in the list select the required SEQ COMMENT DEPARTMENT RACK Pos sa number press on the column of the result O DATE gt To view an entire result select the required result identified in blue then press VIEN see section 5 10 2 hereafter 4 PREVIOUS SCREEN TOOLS MENU l STATUS 16 04 19 36 DAY RES allows an access to the results date list Select the right year month and day to display the results The column RES indicates the number of results in memory Press to see the table of results DATE 11 03 2010 INTERNAL MEMORY Page 66 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 5 SAMPLE ANALYSIS 4 MIL SUCCES E TOOLS STATUS 04 08 16 55 To print send delete or save in an USB key results press It is possible to print send delete or save in a USB key All results Press FREE NB PAGES 10 Selected results Select the first and the last results ces i de numeric keyboard Then press on SEND PRINT SAVE and DELETE the selected result or DELETE ALL To exit the prompt without action press EXIT RACK Pos NOTA the printed report is a list of all selected patients If you press YES the selected results will be deleted from the internal memory and stored in the USB key
27. connectors CONNECTION SYMBOL Not available 1 USB port This USB port can be used ONLY for the printer connection Ethernet connection TCP IP zu Host connection RS232C External barcode reader RS232C Equipotentiality y Power supply cord connection 24V Page 16 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 1 INSTALLATION 1 3 2 Front connectors 3 USB ports eR Any output or input connections except the printer and the barcode reader supplied by ORPHEE cannot be done without the ORPHEE s representative authorization 1 3 3 Power supply block MYTHIC 22 AL 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 AL and if possible in an upper position to avoid the contact with any liquid To disconnect electrically the MYTHIC 22 AL remove the power supply plug from the main circuit In case of replacement of the main power wire supplied with the MYTHIC 22 AL the new one must comply with the local regulation 3X1 5mm cable and 250V 10 plug The MYTHIC 22 AL has been certified with the power supply provided with the instrument If another power supply is used with the instrumen
28. 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 Page 8 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 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 valutazionedellaconformit 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 Geneva 10 08 2010 MYTHIC 22 AL Copyright Orphee SA All Rights Reserved IEC 60825 1 2007 IEC 61010 1 2001 IEC 61010 2 101 2002 IEC 61010 2 081 2001 and A1 2003 IEC 61326 2 6 2005 Annex III N A Name und Funktion Nom et fonction Nome e funzione Name and function Tomasz Tuora CE
29. 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 LEUKOCYTE ANALYSIS 8 2 1 Measurement 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 Leukocytosis WBC gt WBC h Leucopenia WBC lt WBC b LYM Lymphocytes in percentage Lymphocytosis LYM gt LYM h amp or f LYM Lymphocytes in value Lymphopenia LYM LYM b amp MON Monocytes in percentage Monocytosis MON gt MON h amp or MON Monocytes in value NEU Neutrophils in percentage Neutrophilis NEU gt NEU h amp or NEU Neutrophils in value Neutropenia NEU lt 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 Page 78 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 8 TECHNOLOGY 8 2 2 Local blood control limitations In the ca
30. emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Compliance level Class Complies Electromagnetic environment guidance The MY THIC 22 AL 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 immunity The MYTHIC 22 AL is intended for use in the electromagnetic environment specified below The customer or the user of the MYTHIC 22 AL 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 IEC 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 695 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT gt 95 dip 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 flo
31. enclosure sensor Call an Orphee representative Check your reagent sensor Re start the Mythic Wait for the system to reach its temperature Enter an ID and or PID and SID Switch on the printer or invalidate the printings Re start the Mythic MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 105 109 9 SERVICE REF M22AL UM EN 004 MESSAGE INTERN MEMORY CORRUPTED PRINTER DRIVER UPDATE FAILED THE CHOSEN DRIVER IS NOT COMPATIBLE WITH THE MYTHIC SYSTEM SYSTEM EEPROM COM ERROR ACTION Re start the Mythic Re start the Mythic Wait before performing a cycle If persisting re start the Mythic Check the data format Select another lot Replace the bottle and perform a prime Lysis Perform a SYSTEM INIT Perform a SYSTEM INIT Perform a SYSTEM INIT Re start the Mythic Nothing to do Re start the Mythic Nothing to do Re start the Mythic Perform a pistons greasing Perform a SYSTEM INIT Perform a SYSTEM INIT Re start the Mythic Nothing to do Perform a SYSTEM INIT Perform a SYSTEM INIT Re start the Mythic Nothing to do Perform a SYSTEM INIT Perform a SYSTEM INIT Re start the Mythic Nothing to do Perform a SYSTEM INIT Perform a SYSTEM INIT Re start the Mythic Nothing to do Perform a SYSTEM INIT Check your analyzer configuration Check your analyzer configuration Switch on the printer or invalidate the printings Switch on
32. has been restored to previous state Memory full next result will not be saved You have to delete results File has been restored to previous state Indicate that your SETUP has been restored Delete results Delete the stored results A bad Result storage occurred A bad Result storage occurred A bad Result storage occurred A bad Result storage occurred Delete the Q C results of the ongoing lot Internal database as been restored after detecting incoherence Delete the repeatability results Hardware failure on memory Indicate that your SETUP has been released Re start the Mythic Perform a CLEANING Replace the bottle and perform a prime Cleaner Rebuild cycles with good options Communication errors re try Try again if the problem occurs call an Orphee s representative Perform a SYSTEM INIT Check the pump connection Emergency stop please perform a SYSTEM INIT Wait before performing a cycle Change the valve Perform a SYSTEM INIT Close the Fluidic door Run SYSTEM INIT Run Startup Cycle If the problem still occurs call an Orphee s representative Perform an initialization or a SYSTEM INIT May occur by leak of reagent or check tubing in the fluidics Change the valve Replace the container and perform a prime Diluent Check the hardware connection on ALL Board Check the hardware connection on FSC Board Check if your temperature fan is running Call an Orphee s representative Check your
33. number of the last used calibrator The expiry date of the current lot The last date of calibration The operator s name The target values The current coefficients of calibration To enter new values or to modify the values press Rae To calibrate press COEF 1 000 1 008 1 000 O o 1 000 1 000 CHANGE RESULT Press TOOLS then o PRINT to print these information see the print out report above o SEND to send these information o SAVE to store these information in the USB key o EXIT to leave the TOOLS without modification NOTA If the M letter appears on the right of the date of calibration that means that the last calibration was done by manual modification of the calibration factor see section 3 4 5 MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 73 109 7 CALIBRATION REF M22AL UM EN 004 7 1 RUN CALIBRATOR 7 1 1 Calibration blood analysis This screen allows running analysis on calibration blood to perform the MYTHIC 22 AL calibration 4 Miu E TOOLS MENU STATUS 01 05 11 50 ET OS OT HCT PLT This screen allows carrying out the calibration on the parameters measured by the MYTHIC 22 AL To run calibration in open or other vial tube mode o Press BALLE and repeat this operation as long as needed maximum 10 runs The results are displayed in line run after run The statistics calculations are shown at the bottom of
34. 9 T THRESHOLDS TYPE STANDARD L5 Threshold modifications may affect the quality of the results or the alarm detection area We recommend to modify these values only after an Orphee s training UNDO 052 CR2 Press EME return to the manufacturer parameter setting To validate or not the modification see section 8 7 1 To accede to modification of the scattergram threshold INIT STD press PREVIOUS SCREEN STATUS 23 02 15 38 Threshold modifications may affect the quality of the results or the alarm detection area We recommend to modify these values m only after an Orphee s training VALID a ESCAPE ale oum als ee XIN co o afe ayo al oi Press LE to return to the manufacturer s parameter setting Blo oo 060 026 olo ES Qi Press to check the modification on the scattergram of the last run To validate or not the modification see section 8 7 1 To access to modification of the flags threshold press FLAGS o INIT STD Page 32 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 3 INSTRUMENT SET UP PREVIOUS SCREEN TOOLS STATUS 23 02 15 39 VALID ESCAPE UNDO INIT STD 3 4 6 3 Flags level 47 PR
35. CIFICATIONS Occurrence P Specimen Possible Indication of Error on MYTHIC 22 AL Sean 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 CT MCHC d e ano HCT values The limitations listed for Hgb and HCT values interferences s P may cause indirect interferences BBC Count The RDW is determined according to RBC count RDW The limitations listed for RBC may cause indirect interferences interferences Cause Clumped platelets may cause a decreased aggregates on Smear Platelet Aggregation elet count The specimen should be PLT Indication aggregates may be detected on the Severe Microcytosis Megalocytic Platelets RBC agglutination Hemolysis WBC scattergram with N1 amp or N2 amp or L1 amp or HL flags 4 TMPV Cause in case of severe microcytosis microcytes and schizocytes are under the RBC inferior threshold and may be counted with Platelets and cause an erroneously high Plt count Indication VRBC TPIt R1 amp or amp or P2 flags Cause may cause a low inaccurate platelet count as these platelets exceed the upper threshold for the platelet parameter and are not counted Indication PIt TMPV P2 flag Cause agglutinated RBC may trap platelets a
36. CREEN RERUN is only available when the sample become Done D Copyright Orphee SA All Rights Reserved Page 59 109 5 SAMPLE ANALYSIS REF M22AL UM EN 004 5 6 9 STAT or other vial sample run Wear rubber gloves and wash hands with a disinfectant after completion of work Behind the front door you will find hazardous moving parts beware to stay away from these parts if they move when the front door is open and the machine switched on NOTA The analysis can start as soon as the working temperature is reached about 20 min at 23 C room temperature This prompt means that the temperature setting of the enclosure and or the reagent is not ESS reached yet This prompt means that the temperature setting of the enclosure and or the reagent is reached Before launching the run enter the identification of the sample see section 5 6 8 Press on the display of the WORKLIST screen this prompt appears If the sampler is running wait for the complete stop the red light located between the screen and the front door becomes m D and a prompt appears on the pr Screen 4 Never open the door before the complete stop of the sampler otherwise see section 9 5 2 Open the front door by pushing on the mark The door goes down slowly Be careful with laser light of the barcode reader if the red light is present duri
37. ER a 0 81 a a STDU 2 0 0 001 a a a a cuzi 6 61 8 01 8 01 0 01 7 2 TARGET VALUES MODIFICATIONS 4 PREVIOUS SCREEN TOOLS STATUS 01 05 11 52 To modify information relative to a batch or to create a new batch please follow the following steps oo xm From Calibration Menu press e Select the lot number e Select the field to be modified e Enter your new value with the numerical keyboard or with the alphabetical keyboard e Press to load the target and tolerances values and expiry date and lot number from an USB key e To validate or not the modification see section 8 7 1 VALID 001 ABC123 002 ZER456 003 458JFD 004 CBR488 005 WXCTSO The prompt display the lots available in the USB key 006 eel 28 Select the good lot and press LOAD Any modification lot number date or target values involves the deletion of all the associated results still in memory MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 75 109 8 TECHNOLOGY REF M22AL UM EN 004 8 TECHNOLOGY The innovative technology of the MYTHIC 22 AL is covered by six filed or pending patents new innovative concept of optical measurement system and a 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 tech
38. EU clump NH Flag Cause hyper segmented or giant Neutrophils may Seek atypical Neutrophils Atypical overlap EOS clump is TE P 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 ne 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 he ane increase Seek for red cell clumping Indication TMCV VHCT ogee Cause in very rare case of severe microcytosis size evere Microcytosis of microcytes may fall under the minimum eek for microcytes on 5 Microcytosi C f microcy y fall und he mini RBC Seek for microcy threshold Smear Indication RBC TPIt R1 amp or flags Cause in case of macrocytosis size of macrocytes Macrocytosis may overcome the maximum RBC counting zone Indication RBC TMCV R2 flag Cause agglutinated RBC may cause a low inaccurate RBC agglutination RBC count qumpe RRE n Indication abnormal MCH and MCHC values Fragmented RBC Cause RBC fragments schizocytes may agglutinate See fou sdhizacyfes on and interfere with RBC counting Sneak Indication VRBC 1PIt TMPV P2 flag Ad level of WBC may cause an erroneous Centrifuge the sample and Leukocytosis Indication very high WBC gt 100 000 u
39. EVIOUS SCREEN TOOLS STATUS 23 02 15 50 FLAGS LETYPE STANDARD VALID ESCAPE UNDO INIT STD 3 4 6 4 Correction factors 4 Previous screen TOOLS MENU STATUS 4 19 27 VALID Threshold modifications may affect the quality of the results or the alarm detection area We recommend to modify these values only after an Orphee s training Press BALE to return to the manufacturer s parameter setting Press RE to check the modification on the scattergram of the last run To validate or not the modification see section 8 7 1 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 The WBC flags appear when the limits AND limit are reached The RBC and PLT flags appear when the limit OR limit are reached To validate or not the modification see section 8 7 1 Press ESS to return to the parameter setting of the standard type In this menu for each blood type users can define a correction factor which is multiplied by the calibration factor see section 3 4 7 given by a normal calibration see section 7 To validate or not the modification see section 8 7 1 MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 33 109
40. HCT Agglutinin C lacy Indication TMCV LHCT Leukocytosis Elevation of WBC Cause in case of chemotherapy cytotoxic and Abnormal Red Cell immunosuppressive drugs may increase RBC as well Fragility as WBC fragility leading to a low HCT Indication P1 flag Cause in case of Spherocytosis sphered RBC are Gel tav spherscutes on Spherocytosis smaller than normal RBC leading to a low HCT sc 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 e e Indication abnormal MCH and MCHC values Cause may cause a low inaccurate MCV value because of an excessive size Indication VPlt 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 a decrease in the result which is sample dependent Page 48 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 4 SPE
41. ID ESCAPE UNDO PLT MPV 3 4 3 Storage options Q PREVIOUS SCREEN TOOLS STATUS 05 03 20 11 VALID ESCAPE UNDO USB THUMB DRIVE FORMAT Page 36 109 In this menu the user can modify the calibration factors without any calibration with calibration blood AM letter appears on the right of the date of calibration in case of modification in the Calibration Menu The modification of any of these factors without running a calibration blood may affect the quality of the result Copyright Orphee SA All Rights Reserved To validate or not the modification see section 8 7 1 MYTHIC 22 AL can save more than the last 1500 patients with results alarms distribution curves in the internal memory and up to a maximum of 60 000 results in a memory stick USB key with capacity from 128 Mb to 2 Gb maximum Because the technologies of the USB key are very different some of them may not work For more information contact your Orphee representative Choose for a FIFO first in first out mode or real time to Store the results in the resident memory or in a USB key To validate or not the modification see section 8 7 1 MYTHIC 22 AL REF M22AL UM EN 004 3 INSTRUMENT SET UP 3 4 4 Version release Load a new software version only with the agreement of an Orphee s representative Be sure to load the new upgrade in the right folder on the USB thumb drive If you have any doubt please co
42. L be the re diluted RBC TRBC TMCHC pare 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 a decrease in the result which is sample dependent MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 47 109 4 SPECIFICATIONS REF M22AL UM EN 004 Parameter Specimen RC rece action P Possible Indication of Error on MYTHIC 22 AL Centrifuge the sample Cause high level of WBC causes excessive light remove WBC and HGB Y scatter that interferes with Hgb measurement the re diluted RBC part Or Indication very high WBC gt 100 000 uL TMCHC use reference spectrophotometric method Cause in case of high level of lipids in blood will give fy en Use reference manual hyperlipidemia the plasma a milky appearance that causes methods and a plasma blank inaccurate Hgb measurement to determine Hab Indication plasma appearance TMCHC 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 level may lower RBC and increase
43. MPLE ANALYSIS 5 6 8 4 PREVIous SE TOOLS MENU STATUS 30 04 18 16 START UP QUALITY CONTROL WORKLIST em CALIBRATION DISPLAY RUNS RESULTS SHUT DOWN OP LOGOUT 4 PREVious E TOOLS STATUS 15 04 20 22 TEST GUILLOU GAILLARD WAGNER 7 8 1 9 Peee10 PO0008 PO0006 P0001 DUPONT RITCHIE PALADO GUILLOU MAROT RUN RACK NEW ORDER DISPLAY RUN PREVIOUS SCREEN TOOLS STATUS 21 04 17 21 RACK Type Numbe GENDER TEST STANDARD PID 7 ID MARTIN JLP BIRTH DRAW DATE DRAW TIME TYPE MYTHIC 22 AL STAT or other vial Sample Identification From the main menu press 148 31 table to reach the work list From the work list select the demographic data of the sample to be run the line becomes orange or To enter the demographic data of new sample press To modify an existing demographic data select the line then press The setting of the work list can be modified in the Set up see section 3 4 5 Work list Options To run the EZ in STAT mode or Open vial read hereafter press Select the box and enter the modification with the help of the keyboard To validate the modification or not see section 8 7 1 To run this patient in STAT mode or open vial mode press RUN NEEDLE To come back to the work list press MEI 4 PREVIOUS S
44. Mythic 22 AL User s Manual Orph e S A 19 chemin du champ des filles 1228 Plan Les Ouates Switzerland Ph 41 22 884 90 90 Fax 41 22 884 90 99 Web site orphee medical com Cod M22AL UM EN 004 REF M22AL UM EN 004 REVISIONS 28 05 10 Creation 25 06 10 5 Update of the entire document 04 08 10 Update of the sections 3 4 3 3 4 1 3 4 4 5 10 1 7 2 13 08 10 Add the Declaration of Conformity CONTACT ADDRESS MANUFACTURER ORPHEE SA 19 chemin du champ des filles CH 1228 Plan les Ouates SWITZERLAND Tel 41 22 884 90 90 Fax 41 22 884 90 99 http www orphee medical com LOCAL AGENT MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 1 109 REF M22AL UM EN 004 CAUTION 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 operation due to risk of contact with materials that may be infectious CAUTION HOT SURFACE Indicates hot temperatures surfaces and risk of burns CAUTION BIOHAZARD RISK Indicates that wearing gloves is mandatory before performing the described CAUTION CLASS 2 LASER RADIATION Indicates laser radiation and do not stare into the beam NOTA Indicates important additional information The slots and openings in the back or bottom are provided for necessary ventilation To ensure reliable operation of this apparatus o
45. O amp President Orph e SA 19 chemin du Champ des Filles CH 1228 Plan les Ouates Gen ve Orph e SUISSE N f d CH 660 1111002 1 Page 9 109 REF M22AL UM EN 004 Page 10 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 TABLE OF CONTENTS 1 INSTALLATION 2 22 en on nr de Era nn bd enti anne DU Ra SEES L1 UNPACKING act A e CHEN Ee ASE AS A debe ee De o PT Ee TC LLE d ei edes cR 11 25 1 se tienne teinte 113 Visual checking 1 2 INSTALLATION CONSTRAINTS a s ie m 121 Installation place c heh e eedem ee e E e ace Ode td a UR eec a e tea Rte 12 2 Installation environment 1 3 ELECTRICAL CONNECTIONS int antenne atia eat ape na ate ah aportar 1 314 Rear conhe CTODS ioco ace ERR S e le en PN ol clon aio d dr Hd sueta LAND NER EIER 13 2 Front CONNECT OMS ERR EE e Md rauco c TA PRINTER CONNECTEON 4 orti retten roter b eet e e E CER T d eb e eR C P D Rete verla ie ree ERR res 15 CONNECTION CHANGE AND PRIMING REAGENTS L5 Connections ette das S x s p 15 2 Prithitg ie ee toe RR 1 6 STRANSPORTATEON AND STORAGE vori oe c
46. OOTING SCREEN Sampler s eden d RR OUR Hd e UE REGERE tn D IN E GR RR RN 9 3 2 Check sensors M MM te 9 3 4 Check motors fluidics 9 3 5 Log errors vid Mili c tente ten nee LR nn M MR RM en ne tn 9 41 Emergency stop 9 42 Needle or o ring replacemeht sen nn nn SR nn Ni 95 9 43 Baths dismantling vais regen eneeene tede ee td La E eter 98 9 44 Baths ring replacement eeocee pendere i acp o RE C RUMQUE GU MET 100 9 4 5 Aperture block replacement nesana gen ga a p d tert RS 101 9 5 TROUBLESHOOTING OCCURENCES tritt tret tec iet bet et c E D eet e ee ee ive t be eet be tbe 102 9 5 1 Analytical problems 9 5 2 Other problems 9 6 TROUBLESHOOTING MESSAGE 9 7 HYDRAULIC DIAGRAM MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 13 109 1 INSTALLATION REF M22AL UM EN 004 1 INSTALLATION 1 1 UNPACKING 1 1 1 Introduction The MYTHIC 22 AL is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories by an authorized and trained people Only human blood or artificial blood recommended control or calibrator should be run Only the reagents mentioned in this manual are permitted to be used The optimum performances can only be achieved if the cleaning and maintenance procedures are carefully followed see section 9 1 I
47. T GRAPHICS print the LJ graphics o SEND to send targets results and graphics to a host o SAVE to save targets results and graphics in the USB key o EXIT to leave the tool without action CHANGE RESTORE RESULT 4 PREVIOUS SCREEN TOOLS 04 08 17 06 EI e In this display the user can enter the Lot number o Expiry date o Target values and tolerances o Level o Select DIF or CBC mode To load target values and limits press LOAD To validate or not the modification see section 8 7 1 002 ZER456 003 458JFD 004 CBR488 005 WXC789 The prompt display the lots available in the USB key Select the good lot and press LOAD 013 MBK3781 014 ABC123 zx mz z zxr jz Page 70 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 6 QUALITY CONTROL 6 2 2 Run control blood 4 PREVIOUS SCREEN STATUS 01 05 11 47 This screen allows running a control blood to check the precision of the MYTHIC 22 AL Sel RBC HCT RDW GEL 6 5 5 8 To run a control blood analysis in open tube mode o Press LES and repeat this operation as long as needed maximum 20 runs The results are displayed in line run after run SE EDT Va ad The statistics calculations are shown at the bottom of the display and are automatically done after each run The column SEL allows selecting or unselecting a result the stat
48. WBC scattergram with N1 amp or N2 amp or L1 amp or HL flags Indication aggregates may be detected on the WBC scattergram with N1 amp or N2 amp or L1 flags Seek for NRBC on smear Seek for Platelet aggregates on smear MON amp Large or atypical lymphocytes Small Neutrophils Lymphoid amp myeloid Blasts Excessive number of basophils Immature monocytes Cause These lymphocytes are larger than normal lymphocytes and tend to overlap the MON clump on the scattergram Indication reduced LYM MON gap with LYM band RL flags Cause These few segmented and granulations lacking Neutrophils tend to overlap the MON clump on the scattergram Indication reduced NEU MON gap with NL flags Cause Blasts are large and polymorphic immature cells that may overlap all normal cells clumps Indication reduced absent LYM MON even MON NEU LYM gap with overlapping population RL amp or NL amp or HL flags Cause in case of basophilia the basophils clump may overlap the MON clump on the scattergram Indication reduced LYM MON gap RL amp or HL amp or NL flags Cause Immature monocytic line cells proliferate in certain pathologies multiple myeloma monocytic leukemia and 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 Seek for Erythroblasts on smear
49. a prime Diluent Replace the bottle and perform a prime Lysis The USB thumdrive has an incompatible tree structure for the analyzer try another one The USB thumdrive has an incompatible tree structure for the analyzer try another one The USB thumdrive has an incompatible tree structure for the analyzer try another one The USB thumdrive has an incompatible tree structure for the analyzer try another one No memory available in USB for storage You have to delete some data to work Connect an USB thumdrive The USB thumdrive has an incompatible tree structure for the analyzer try another one The USB thumdrive has an incompatible tree structure for the analyzer try another one The USB thumdrive has an incompatible tree structure for the analyzer try another one The USB thumdrive has an incompatible tree structure for the analyzer try another one The USB thumdrive has an incompatible tree structure for the analyzer try another one Select the correct version Replace the waste container The USB thumdrive has an incompatible tree structure for the analyzer try another one The USB thumdrive has an incompatible tree structure for the analyzer try another one The USB thumdrive has an incompatible tree structure for the analyzer try another one The USB thumdrive has an incompatible tree structure for the analyzer try another one No memory available in USB for storage You have to delete some data to wor
50. ading and analysis NOTA To perform an emergency stop in case of any problem push shortly on the on off button and see section 9 5 2 Before loading the FIRST rack when the MYTHIC 22AL is USER FREDDY EE operating the light between the screen and the front door NUMBER OF S 9 is red press located at the top of all screens to see NT RACK IDENTIFICATION CHENE which cycle is in progress and wait for the green light the other racks be added at any time on the first Place the rack in the right position as shown on the picture The round white label must be placed on the left of the instrument If the racks are in bad position or not present the auto loader does not start or stop and a prompt appears on the screen to inform the user that no rack is present NOTA Introduce a rack or place it in the good position 4 PREVIous SE TOOLS MENU STATUS 15 04 20 22 5 510 PID ID 90 00 0 T 01604 4 T 90009 PO0007T GUILLOU 02 03 4 T 9001 8 GAILLARD 03 04 5 T 0007 Pao010 WAGNER 9001 E The run of the rack launched after having done the 9001 1 RITCHIE 0007 Po0008 PALADO demographic entries see section 5 6 2 and followings 0004 Po0006 GUILLOU 0004 P0001 MAROT Before launching the sampler you must read all the section 5 6 When everythi
51. ains the semi conductor light source a beam adjustment glass smear and lens A flow cell made of 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 7 SOFTWARE 8 7 1 Functionalities Common buttons PREVIOUS SCREEN TOOLS MENU STATUS These four keys located at the top of the screens are C gm RSR allows to come back to the previous display KU allows to come back to the MENU display wherever you are in the arborescence depends on the screen it allows to open a window dedicated to perform an action for example to select information to print send save or delete it allows to check the status of the sampler ca allow to move at the beginning or at the end of the table 1 1 allow to move on the right or on the left page by page or column by column E E allow to go to the first or the last line of a table allow to change for the previous next button in grey instead of white EUR AM that it is not available at this moment The following buttons are common for the screens where entries are possible YALID Allows to leave the screen after modifications a prompt appears to request a confirmation Allows to delete the modification in progress in one box Allows to cancel all modificatio
52. ast 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 basophils HL High Lymphocytes Presence of basophils small Neutrophils without granulations or few segmented band cells NL Neutrophils Low Presence of small Neutrophils without granulations or few segmented band cells or hyper basophil Monocytes NH Neutrophils High Presence of giant Neutrophils hyper segmented Neutrophils eosinophils with few granulations or damaged eosinophils The WBC flags appear when the AND limits are reached These flags may appear if the blood was not stored in good conditions or if it was sampled too many times more than 20 times Page 82 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 8 TECHNOLOGY DIF parameters display rules If one or more DIF parameters LYC MON NEU EOS or BAS are followed with a star XXX the sample must be checked on smear Basophil result must be checked on smear if it is followed by a star XXX 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 CL1 CL5 L1 Presence of platelet aggregate erythroblast or small lymphocytes at the left of CL1 L5 Presence o
53. by an authorized people Only human blood or artificial control blood should be run Only the reagents mentioned in this manual are permitted to be used optimum performances can be only achieved if the cleaning and maintenance procedures are carefully followed All parts or surfaces of this apparatus could be potentially infective Use adequate protection to prevent any risk of contamination gloves glasses disinfectant The elimination of waste supplied by this apparatus must be done in compliance with your local authorities MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 3 109 REF M22AL UM EN 004 This equipment has an embedded class 2 laser product By removing the protect cover operator could have exposure to hazardous laser radiation Do not stare into the beam All operations of service must be do after equipment is switched off Wavelength 650nm Beam divergence 54 Pulse duration and repetition rate 200 scans s Maximum power 1mW Page 4 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 This equipment needs special precautions regarding general requirements for safety Guidance and manufacturer s declaration Electromagnetic emissions The MYTHIC 22 AL is intended for use in the electromagnetic environment specified below The customer or the user of the MYTHIC 22 AL should assure that it is used in such an environment Emissions test Harmonic
54. centration value 140x10 mm 8x105 mm 20g dL 3000 10 mm Measured carry over 76 0 29 0 13 0 0 07 Maximum carry over 76 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 Results of the correlation done with one commercial instrument SYSMEX XE 50009 for the MYTHIC 22 AL and HORIBA ABX PENTRA 1200 for the MYTHIC 22 and with normal blood samples without alarm MYTHIC 22 vs PENTRA 120 MYTHIC 22 AL vs SYSMEX XE5000 PARAMETERS N R N R WBC 103 mm 127 0 997 103 0 984 LYM 113 0 989 97 0 935 MON 113 0 935 97 0 896 NEU 113 0 988 97 0 957 EOS 113 0 950 97 0 906 BAS 113 0 187 97 0 253 RBC 105 mm 127 0 991 103 0 993 HGB g dL 127 0 997 103 0 993 HCT 127 0 984 103 0 984 MCV fL 127 0 947 103 0 940 RDW 127 0 746 103 0 836 MCH pg 127 0 963 103 0 954 MCHC g dL 127 0 151 103 0 623 PLT 103 mm3 127 0 990 103 0 960 MPV fL 127 0 890 103 0 886 2x Ly Calculation method r n Zx n Zy Zy Mode to mode closed tube and other vial acceptable differences PARAMETERS MEAN DIFFERENCE whichever is greater WBC 103 0 5 5 RBC 10 mm 0 3 or 2 HGB g dl 0
55. cians only The entry enables to modify the biologist password The entry JOD AVY I enables to select the date format Printer set up menu is intended to present the printing report To select an option on the report press on the corresponding case To enter a header use the keyboard To validate or not the modification see section 8 7 1 Page 34 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 3 INSTRUMENT SET UP 3 4 1 Communication 4 Previous screen TOOLS STATUS 04 08 16 05 Reserved for Field Service Engineer Hove To set up the connection between MYTHIC and Host HOST SERIAL C HOST NET To validate or not the modification see section 8 7 1 TRANSMIT HANDSHAKE SERIAL PARAM NET PARAM 3 4 2 1 Serial Param 4 PREVIOUS SCREEN TOOLS STATUS 12 03 08 33 VALID 115200 ESCAPE Reserved for Field Service Engineer M BIT vis INO FLOW 3 4 2 2 Netware Param PREVIOUS SCREEN TOOLS STATUS 12 03 08 28 VALID T EET Reserved for Field Service Engineer 192 168 103 ESCAPE 1200 UNDO MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 35 109 3 INSTRUMENT SET UP REF M22AL UM EN 004 3 4 2 Calibration factor PREVIOUS SCREEN TOOLS STATUS 23 02 15 52 VAL
56. d by the MYTHIC 22 AL see section 8 Active components Solid content 0 9 Others components Buffer Preservative Description Clear and odorless aqueous solution Storage At room temperature until the expiry date labeled on the bottle Precautions Mayn 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 Page 42 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 4 SPECIFICATIONS 4 3 2 Lytic reagent OnlyOne ORPHEE code number HM22 002 1 Opening shelf life 60 days Application Only One Lytic reagent is used as unique leukocyte and hemoglobin reagent to lyse red blood cells enabling cells subpopulations differentiation and counting and quantitativel
57. d 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 AL Copyright Orphee SA All Rights Reserved Page 81 109 8 TECHNOLOGY REF M22AL UM EN 004 8 5 2 Instrument Flags W CL Suspicion of WBC aperture clog if it persists run a concentrated cleaning see section 9 1 2 R CL Suspicion of RBC aperture clog if it persists run a concentrated cleaning see section 9 1 2 O CL Suspicion of Optical injector clog if it persists run 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 START UP cycle INS T A temperature enclosure reagents or ambient is out of range see section 9 5 2 INS P Pressure default see section 9 5 2 8 5 3 Leukocytes Flags SCATTERGRAM FLAGS NL IC N1 N2 H R 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 erythrobl
58. d without tool see section 9 3 2 The maintenance of these parts is very easy to perform 8 6 3 Counting bath module This module allows to count the WBC and RBC PLT 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 4 Syringes module This module two patents enables To draw the sample To distribute the reagents To drain the baths To do the vacuum necessary for counting To push the waste to the waste container To push the WBC sample and the diluent sheath into the flow cell It is made with a manifold maintaining the fluid commutation valves and with the syringes block including five syringes The sampling syringe The lysis syringe The two waste and vacuum pressure syringes And the diluent syringe Single motor drives the five syringes 8 6 5 Optical manifold This manifold allows driving the different reagent towards the counting bath module or towards the optical bench It maintains seven commutation valves Page 84 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 8 TECHNOLOGY 8 6 6 Optical bench This very important part two patents allows measurement of the leucocytes sub population It is made of three parts An illumination module which cont
59. datory to read the section 8 5 to understand the flags meaning The lower part describes the machine trouble see section FLAGS L IRLNIN2 8 5 2 WORKLIST RUN NEEDLE STOP RACK 4 Previous SE TOOLS STATUS 16 04 19 27 Press LUE to reprint or to resend the result MCHC ROW To print the result press To send the result press NEN To close the window press WORKLIST RUN NEEDLE STOP RACK Page 62 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 5 SAMPLE ANALYSIS 5 8 PRINTING Once the analysis is finished the MYTHIC 22 AL prints a result report To modify the printing presentation or to disconnect the printers see section 3 4 1 To load a new printer driver see section 3 3 5 8 1 PCL3 LX 300 USB model report One result per page DIF mode ORPHEE NEDICAL Presentation Results MYTHIC 22 CBC mode ORPHEE MEDICAL Presentation Results MYTHIC 22 Name Patient Id Comments Sample Id 60017 Type STANDARD Operator ID SAS Date 14 12 2005 11 25 56 90032 Result Flaas Unit Normal Limits WBC 5 7 4 0 12 0 48 2 25 0 50 0 MONA 11 3 h 2 0 10 0 NEUX 42 8 L 50 0 80 0 EOS 5 8 8 8 5 8 BASA g 7 9 80 2 0 LYM 2 3 1 0 5 9 MOM 6 8 1 1 8 NEU 2 4 2 0 8 0 EOS 9 3 9 0 0 4 BAS 8 0
60. ded separation distance Conducted RF 3 Vrms d 1 2 P IEC 61000 4 6 150Khz to 80Mhz Radiated RF 3 Vrms d 1 2JP 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 t NOTE 1 At 80Mhz and 800MHZ the higher frequency range applies NOTE 2 Theses guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM an FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should considered If the measured field strength in the location in which the MYTHIC 22 AL is used exceeds the applicable RF compliance level above the MYTHIC 22 AL Should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary
61. e and cleanable Unscrew the two parts of the filter remove the o ring and clean the part with the grid under water the grid is fixed with the part Reassemble with the two parts and screw the two parts completely If the o ring is missing or if the filter is not completely screwed the MYTHIC 22 AL will stop with a pressure alarm NEEDLE RINSING DEFAULT see section 9 5 2 Open the front door only when the light is green o see section 5 6 8 Be careful with laser light of the barcode reader if the red light is present during the opening of the door close it switch off the AL and call Orphee representative The barcode reader is a laser CLASS II never dismantles the cover in case of problem call Orphee representative Clean the mirror of the barcode reader with soft paper and a glass cleaner MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 91 109 9 SERVICE REF M22AL UM EN 004 9 2 CLEANING CYCLES 4 rev SE TOOLS MENU STATUS 01 05 11 18 9 3 TROUBLESHOOTING SCREEN 4 PREVIous TOOLS MENU STATUS 01 05 11 18 4 PREVIous screen TOOLS MENU STATUS 01 05 12 06 Page 92 109 To have access to the hydraulic cycles press SERVICE from the MAIN MENU then press Yo dan d cure baths the flow cell and the waste syringes END To fill the counting baths the flow cell and the waste syringes Gens O To
62. el situated at the top of the rack allows identifying the type and the number of the rack The arrow helps the user to introduce the rack in the good position inside the loader In this example the type is O1 dedicated for the type of tubes listed in section 5 5 2 and the number of the rack In this example the type is O2 dedicated only for the SARSTEDT tube and the rack number O2 Before loading the sample tubes in the rack check if all the caps are perfectly closed Before load the rack with the sample tube check if all the barcode labels are not altered The barcode label of the sample must be placed in front of the rack The barcode labels at the bottom of the rack are used to know if a sample tube is present The barcode label situated between the first two positions is dedicated to identify the type and the number of the rack The barcode label of the sample must be placed in front of the rack Bad position of the label Good position of the label If the barcode of the sample cannot be read bad position altered unknown code only the rack position NOTA RAC POS will appear with the result see section 5 7 If the barcode of the rack is missing or altered the rack will be ejected automatically Page 56 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 5 SAMPLE ANALYSIS 5 6 7 2 Lo
63. ement of the o ring is MANDATORY for each disassembling of the needle Open the door on the right side by unscrewing the two quarter turn screws with the key provided in the kit Open completely the door and then lift it to remove The needle is in front of the counting chambers First remove the top of the needle from the clip leave the needle free in front of the clip do not pull a lot the upper needle MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 95 109 9 SERVICE REF M22AL UM EN 004 Remove the sampling module while slightly lowering the clip to the bottom Pull the needle and the rinsing head system towards outside Remove the tubing fixed at the end of the needle only if you want to change the needle Leave the tubing connected if you only change the o ring Page 96 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 9 SERVICE Unscrew the serrated roller which maintains the seal and the needle Raise up together the serrated roller the needle and the o ring from the rinsing head Remove the o ring Replace the needle and or the o ring Only grease and lightly the o ring between your fingers If the needle is greased the grease could block the grooves and create diluent leak and the results would be altered REASSEMBLY PROCEDURE To reassemble the unit ca
64. ems 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 any chanaes or modifications to this equipment not expresslv approved by C2 The symbol on the product indicates that this product may not be treated as household waste Instead 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 MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 7 109 REF M22AL UM EN 004 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 indirizzo della ditta 19 Chemin du Champ des Filles Name and address of the firm 1228 Plan Les Ouates Wir erkl ren in alleiniger Verantwortung dass Nous d clarons sous notre propre responsabilit que Dichiariamo sotto nostra responsabilit che We declare under our sole responsibility that das Medizinprodukt f r die In vitro D
65. ent and Log Out Section 7 section 5 11 Analysis section 3 1 performing Patient Archive Section 5 10 section 5 5 Page 24 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 2 GENERAL OVERVIEW 2 4 2 Dilution fluidic part All the fluidic part is on the right side of the instrument and consists of five modules only Sampling module o Rocker patented Manages the rise and descent of the needle Syringe module patented consists of one block o Reagent syringes Diluent lysis sampling and air syringes o Liquid valve manifold assembly and tubing Counting chambers o WBCand RBC counting chambers and hemoglobin measurement o Liquid valve manifold assembly and tubing Optical Manifold o Liquid valve manifold assembly and tubing Optical bench o Optical bench patented with its flow cell patented MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 25 109 2 GENERAL OVERVIEW REF M22AL UM EN 004 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 Fluidics sample needle rocker syringe block motors Autoloader loading transfer mixing and unloading Display and keyboard Connection mode RS232 Ethernet Printer Measurement Optical and resistive counting hemoglobin measurement
66. ent container is at the same level as the analyzer Page 102 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 9 SERVICE 9 5 2 Other problems ORIGIN PROBLEMS SOLUTIONS ANALYZER Diluent leaks around the needle Check the rinsing needle block presence of clots and clean it if during the run cycle necessary Clean the needle by removing the grease in the grooves see section 9 4 2 No starting Check the power supply connection wires No display Check the flat cable ID and or PID typing impossible ID and or PID are mandatory see section 3 4 3 Message TEMPERATURE OUT OF RANGE or flag INS T ERROR Check the origin of the problem of temperature in section 9 3 2 Trigger temperature values Ambient 17 C lt gt 35 C Enclosure 32 C lt gt 40 C Reagents 34 C lt gt 45 C Stop of the analysis Proceed as stated hereafter for all prompt starting with CYCLE Wait the complete stop of the sampler the red LED becomes green then Perform a SYSTEM INIT MENU SERVICE if the problem remains call your Orphee s representative Message CYCLE PRESSURE DEFAULT or Flag INS P Cases of occurrence each case has his dedicated prompt NOTA For all these occurrences also check the level of the reagents NEEDLE RISING DEFAULT check the in line filter locking see secti
67. f immature cells at the right of CL5 8 5 4 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 a 8 5 5 Platelet Flags P1 O to CP1 Presence of abnormal quantity of debris or small cells P2 P to CP2 Presence of schizocytes P3 CP3 to CP3 2 Presence of microcytes The RBC and PLT flags appear when the limit OR limit is reached 8 5 6 QC Flags QC_F QC Failed This flag appears when the result of the QC run was out of the limits This flag is printed with each result QC_ND QC Not Done this flag appears when no QC was run before the analysis of samples This flag is printed with each result See section 6 8 5 7 STARTUP Flags SU F STARTUP Failed This flag appears when samples are run after a bad START UP This flag is printed with each result SU Nb STARTUP Not Done This flag appears when samples are run without START UP running This flag is printed with each result See section 5 4 MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 83 109 8 TECHNOLOGY REF M22AL UM EN 004 8 6 HYDRAULIC amp MECHANIC DESCRIPTION The hydraulic part of the MYTHIC 22 AL is very simple and made of these modules 1 Auto loader module 2 Sampling module 3 Counting bath module 4 Syringes module 5 Optical
68. f the MYTHIC 22 AL has been stored at a temperature lower than 10 C it must be left at room temperature during 24 hours before power on 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 AL from the box Starter kit contents INSTALLATION KIT MAINTENANCE KIT QTY Designation QTY Designation 1 Tubing 23 DILUENT 1 Tubing 50 1 Tubing 24 WASTE 10 Silicon Sleeve 1 150W DC adaptor 5 Tie wraps 1 European Power line cord 2 Head O ring 1 MYTHIC 22 AL User s manual L agn 1 Screwdriver Slot 1 4 1 Short Arm TORX T10 Tool 1 Short Arm TORX T20 Tool 10 Racks Page 14 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 1 INSTALLATION 1 1 3 Visual checking Open the door on the right side by unscrewing the two quarter turn screws with the key provided in the kit Open completely the door then lift it to remove Unscrew the two quarter turn screws with the key provided in the kit To remove the unloading table push to the back first then lift it Check the good fixation of the air pump Remove the plastic wedge of the bath block To be checked 1 Counting chambers perfectly locked in
69. h a new analysis starts 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 Press in this zone to have a clear explanation of the flags At the bottom of the screen MEIN allows coming back to the Work list screen and allows launching a run in Open Vial mode See section 5 6 9 WORKLIST RUN NEEDLE STOP RACK MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 61 109 5 SAMPLE ANALYSIS REF M22AL UM EN 004 4 PREVIous scREEN TOOLS STATUS 16 04 19 22 NEU M Example of an abnormal result analysis in DIF mode with L flags located at the right of the results and in the flag box under the result It is mandatory to read the section 8 5 to understand the flags meaning d FLAGS LIRLNIN2 WORKLIST RUN NEEDLE STOP RACK Press on the flags zone to open the flags window STATUS 16 04 19 25 With regards to the different flags found by the MYTHIC 22 AL the upper part proposes a list of the cells to be checked on the smear In no case this proposal is a commitment it is man
70. he DC adaptor Doing so many create a danger of electric shock To avoid electric shock never touch the inside of the DC adaptor Make sure to plug the power cord in until it is firmly inserted When removing the power cord make sure to hold the power plug when pulling the plug from the outlet Do not touch the power cord or DC adaptor with wet hands If this apparatus does not operate normally in particular if there are any unusual sounds or smells coming from it unplug it immediately and contact your service center Be sure to contact an authorized service center when installing your set in a location with heavy dust high or low temperatures high humidity or chemical substances Failure to do so may cause serious damage to your set Use only a properly grounded plug and receptacle An improper ground may cause electric Shock or equipment damage To disconnect the apparatus from the mains the plug must be pulled out from the mains socket therefore the mains plug shall be readily operable Do not install the product in an unstable location such as a shaky table or a location exposed to vibration Do not drop or impart any shock to the product If the product is damaged disconnect the power cord and contact your service center Always replace or use parts of the apparatus supplied by your service center The MYTHIC 22 AL is an automated hematology analyzer for in vitro diagnostic to be used in clinical laboratories
71. he following WBC 0 5 RBC 0 1 HGB 05 PLT 10 If the level is higher MYTHIC 22 AL displays a window START UP FAILED press OK and perform a new start up otherwise every result will be printed with Start Up not saad Msi done message An automatic Start Up can be performed at a scheduled time see section 3 4 8 OP LOGOUT NOTA The startup can start as soon as the working temperature is reached about 20 min at 23 C room temperature WARNING This prompt means rrREORHATIOR This prompt means HEATING IN PROGRESS PLEASE that the SET TEMPERATURE REACHED that the temperature temperature setting setting of the of the enclosure enclosure and or the ELSE and or the reagent OK reagent is reached is not reached yet MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 51 109 5 SAMPLE ANALYSIS REF M22AL UM EN 004 5 5 PREPARATIONS BEFORE ANALYSIS 5 5 1 Blood collection 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 CBC and 5 part diff results are available up to 48 hours after the blood draw and if the sample is stored early at 4 to 8 C more flags may occur The results and or the number of flags may be affected in case of too much sampling in the same tube around 20 times in function of the type of blood an aged and or abnormal bl
72. heir fingers between pistons and the syringe body Wear rubber gloves and wash hands with a disinfectant after completion of work Open the door on the right side and remove the unloading table see section 1 1 3 Put a small nut of grease on a finger Put a THIN FILM of grease around each piston Z Turn the two big pistons waste pistons with the help of the key provided in the installation kit Keep on putting a thin film of grease around each piston The other pistons can be turned with fingers Page 90 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 9 SERVICE 9 1 4 In line filter cleaning D f The in line filter allows to eliminate the small pieces of rubber cap which could be generated in case of multiple sampling of the same sample or if the rubber cap quality is poor we N Wear rubber gloves and wash hands with a disinfectant after completion of work Exchange or clean the filter following the maintenance table see section 9 1 1 or when the message NEEDLE RINSING DEFAULT appears see ection 9 5 2 Disconnect the luer connector and let the other tubing connected on the filter Unscrew the luer part of the filter from the part remaining fixed Always open the filter after the disconnection of the luer to avoid losing the o ring The filter is dismountabl
73. iagnostik le dispositif m dical de diagnostic in vitro Mythic 22 AL il dispositivo medico diagnostico in vitro the in vitro diagnostic medical device Ref M22AL mit folgender Klassifizierung nach der Richtlinie ber In vitro Diagnostika 98 79 EG avec la classification selon la directive relative aux dispositifs m dicaux de diagnostic in vitro 98 79 CE con la classificazione secondo la direttiva relativa ai dispositivi medico diagnostici in vitro 98 79 CE classified as follows according to the directive on in vitro diagnostic medical devices 98 79 EC Produkt der Liste A Anhang II Dispositif de la liste A annexe II Dispositivo dell elenco A allegato II Device of List A Annex II L Produkt der Liste B Anhang II Dispositif de la liste B annexe II Dispositivo dell elenco B allegato II Device of List B Annex II L Produkt zur Eigenanwendung das nicht in Anhang II genannt ist Dispositif destin l autodiagnostic non list dans l annexe II Dispositivo per test autodiagnostico non elencato nell allegato II Device for self testing not listed in Annex II x Sonstiges Produkt Autre dispositif Altro dispostivo Other device allen Anforderungen der Richtlinie ber In vitro Diagnostika 98 79 EG entspricht die anwendbar sind remplit toutes les exigences de la directive relative aux dispositifs m dicaux de diagnostic in vitro 98 79 CE qui le concernent soddisfa tutte le disposizioni della direttiva relativa ai
74. ights Reserved MYTHIC 22 AL REF M22AL UM EN 004 2 GENERAL OVERVIEW 2 3 OVERVIEW f MYTHIC 22 AL consists of 9 main parts 1 Auto loader system 2 Display 3 Dilution hydraulic part 4 Mono electronic board 5 Reagent tray 6 Connection 7 External power supply block 8 Printer 9 Barcode reader option 2 4 MAIN PART DESCRIPTION 2 4 1 Display 4 Previous screen TOOLS 1 MENU 1 STATUS 1 30 04 18 16 START UP SHUT DOWN Use only a soft paper to clean the screen never use direct liquid otherwise the screen could be damaged MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 23 109 2 GENERAL OVERVIEW REF M22AL UM EN 004 Main Menu description Start U insin d MAU Direct Display of ses Sansa Send a the sampler Date and Time previous blank control Select System status main menu status screen Section 5 2 Options Section 3 2 Reagent replacement 4 PREVious screen TOOLS STATUS 30 04 18 16 section 5 3 QUALITY CONTROL START UP Mythic Parameters Section 3 Quality Control Section 6 Maintenance and Service Menu HORKLIST DISPLAY RUNS Mythic Events Logs Section 5 9 em Full screen run CALIBRATION RESULTS displayed Section 3 1 SHUT DOWN OP LOCOUT System init Section 9 4 1 Cleaning and Work list Log In and Calibration standby mode managem
75. iner To use 20 liters diluent container add 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 AL It is mandatory to collect the waste in a container and to treat it in compliance with your local regulations Page 18 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 1 INSTALLATION 1 5 2 Priming When using the MYTHIC 22 AL for the first time it is necessary to perform a complete prime of the fluidic circuit This operation should be done by a Field Service Engineer Before starting be sure that all the reagent and waste tubes are properly connected The reagents must be stored 24 hours minimum at room temperature before use Priming procedure D Switch on Connect the power supply block see section 2 3 4 Press the ON OFF button o The logo Orphee appears during a few seconds Q Login 4 PREVIous scrEEN TOOLS MENU STATUS 01 05 11 34 The operator s identification display appears P Enter the user s identification the password see section PassWonD EL 3 1 validate not the modification see section 8 7 1 AUTONOMY
76. istics are done with the selected results only RUN NEEDLE 4 Miu ES I TOOLS MENU STATUS 01 05 11 47 MCV MPY 9 0 8 7 8 7 8 7 To print send or delete a result selected press MAES Press LJ to open the Levey Jennings graph screen RUN NEEDLE MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 71 109 6 QUALITY CONTROL REF M22AL UM EN 004 6 3 REPEATABILITY 4 Previous scrEEN TOOLS MENU STATUS 30 04 18 16 START UP To run repeatability first press SERVICE QUALITY CONTROL HORKLIST DISPLAY RUNS SHUT DOWN CALIBRATION RESULTS OP LOGOUT This screen allows carrying out a test of repeatability on all the parameters measured by the MYTHIC 22 AL M To run repeatability analysis in Rack mode Check the number of sampling to change see section 3 4 4 o Enter the RAC POS of the sample to analyze o Press illias 4 Previous screEN TOOLS STATUS 16 04 20 02 It is mandatory to change for a new cap Nb of REPET Samples 10 after a maximum of 20 piercings he WBC RBC HCT MEAN 7 1 4 49 A 2 2 dide STDV 2 4 0 51 22 37 6 0094 1 To run repeatability in open tube mode 35 5 11 3 9 A o Press BALE ond repeat this operation as long RUN NEEDLE RUN RACK as needed maximum 20 runs The results are displayed in line run after run The stati
77. k Connect an USB thumdrive The USB thumdrive has an incompatible tree structure for the analyzer try another one The USB thumdrive has an incompatible tree structure for the analyzer try another one The USB thumdrive has an incompatible tree structure for the analyzer try another one The USB thumdrive has an incompatible tree structure for the analyzer try another one The USB thumdrive has an incompatible tree structure for the analyzer try another one Select the right version Replace the waste container MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 107 109 9 SERVICE REF M22AL UM EN 004 9 7 HYDRAULIC DIAGRAM a 4 i z a 8 g U3NY319 a E AIR IN gt gt S 3SA7 m m Ch YOSN3S uv m m af 2 n b e i dE 2 z D o 5 a n s a SONIWAS LNY MIA n m Bio YAS 31SVM YAS 31SYM Page 108 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL
78. logist reserved for complete settings See section 3 4 To validate or not the modification see section 8 7 1 SAVE RESTORE Press to save load RESTORE print or delete all the settings from T i i ings an USB key Three pages are required to print all the settings EXIT MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 29 109 3 INSTRUMENT SET UP REF M22AL UM EN 004 3 4 ADVANCED SET UP 4 PREVIous TOOLS MENU 3 4 1 4 Previous screen TOOLS STATUS Sampler option STATUS OVER PANIC LIMITS ON FLAGS ON CLOGS M CONSECUTIVE CLOGS M CONSECUTIVE FLAGS SAMPLER MANDATORY REPEATABILITY 3 4 1 4 TOOLS MENU OPTIONS Analysis options STATUS ALWAYS ID T ALWAYS PID T RUO T US MODE T ABSOLUTE DIF T QC ALARMS UNITS STANDARD M BOLD DISPLAY T STARTUP ALARMS K D F PANIC LOW Iv DIL Iv REJECT Iv PANIC HIGH F LIMIT HIGH F LIMIT LOW 30 04 19 00 04 08 15 37 VALID UNDO 30 04 19 01 VALID This menu is reserved to biologist see section 3 1 Any modifications may affect the quality of the results We recommend to modify these values only after an Orphee s training Please refer below for the description of each key RERUN For each type of blood you can select the conditions OVER PANIC LIMITS see section 3 4
79. loves and wash hands with a disinfectant after completion of work After opening any doors or dismantle any parts for performing a cleaning or a repairing take attention with all metal sheets which can injure your fingers 9 1 MAINTENANCE 9 1 1 Maintenance table NOTA This table is made for an average number of 150 samples per day For more please proportionally increase the number of maintenances MAINTENANCE DAILY WEEKLY QUARTERALY HALF A YEAR ANNUALLY 11250 cycles 22500 cycles 45000cycles User Tech User Tech User Tech User Tech User Tech Reagents level x Start Up X Automatic cleaning X Concentrate cleaning X X Shut down or concentrate cleaning X Cover cleaning X Piston greasing X X In line filter cleaning X X Barcode cleaning X X Needle o ring replacement X Syringes o ring replacement X Motor screw greasing X MAINTENANCE TO BE DONE BY THE USER yellow boxes Reagents level control see section 5 3 Start up see section 5 2 Automatic Cleaning The cleaning is automatically performed by the MYTHIC 22 AL 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 AL in case of analyzes of pathological samples or if there are too many flags and too often Concentra
80. lush and a Cleaning Cycle and then a Bleach cycle if unsuccessful Check the level bubble flow in the WBC bath during the run cycle Check the reagent and enclosure temperature 5 DIFF No result or bad stability No HGB amp WBC Check the lysis level Check the right lysis tubing connection to the WBC bath Check the valve No 9 HGB amp WBC OK Perform a Back flush Cycle and then a Bleach cycle if unsuccessful Check the valves No 12 13 16 8 17 Check the reagent and enclosure temperature Check the preampli connection wires Rejection Check the results on blood smear RBC No result No HCT amp PLT Check the bath wires Perform a Cleaning Cycle and then a Bleach cycle if unsuccessful Bad stability HCT amp PLT Perform a Back flush and a Cleaning Cycle and then a Bleach cycle if unsuccessful Check the bubble flow level in the RBC bath during the run cycle Check the bubble flow level 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 bubble flow level in the WBC bath during the run cycle Rejection Close the door Perform a new Start Up cycle Flag INS_H Close the door Perform a new Start Up cycle ALL Bad results Check the diluent level and if the tubing is pinched Check if the dilu
81. manifold 6 Optical bench The modules are connected together by semi rigid tubing 8 6 1 Auto loader module This module patented enables to load transfer mix and unload the racks Ten racks of five tubes can be loaded The loading can be done continually The racks are loaded on the guide rail by a loading screw then displaced by another screw transfer screw The rail which maintains the rack can also rotate for mixing the blood inside the tubes The blood is mixed by complete returning Each sample is identified with the barcode reader before the sampling Each rack is also identified by the barcode reader The speed mixing is 25 reversals per minute with a minimum of 20 reversals for a first mixing then 10 per minute The system allows the rerun of the sample before the displacement to the next sample tube see section 3 4 1 When all the samplings are done for a rack it is unloaded by the unloading motor 8 6 2 Sampling module This module two patents enables to pierce the cap of the sample tube with one needle only 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 the sampling needle up and down 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 remove
82. nd cause a low inaccurate Plt count Indication abnormal MCH and MCHC values Cause hemolysed samples contain RBC stromas that cause a high inaccurate PIt count Indication abnormal MCH and MCHC values LRBC 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 a decrease in the result which is sample dependent MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 49 109 5 SAMPLE ANALYSIS REF M22AL UM EN 004 5 SAMPLE ANALYSIS 5 1 VERIFICATIONS BEFORE STARTING Before starting MYTHIC 22 AL 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 SWITCH ON Press ON OFF button on the printer to start If needed switch on the a supply the power supply can stay on Press ON OFF button on the Mythic The initialization menu is displayed and MYTHIC 22 AL performs a home position checking for the three motors of the fluidics and the four motors of the auto loader If one or two racks are always inside the rail they are transferred to be unloaded 4 PREVIOUS SCREEN TOOLS STATUS
83. ng is ready press read the maid NOTA on the following page NEW ORDER DISPLAY RUN STAT This prompt appears if the STARTUP has not been done Run a STARTUP see section 5 4 otherwise a message Startup not done will be km printed on all results printings The sampler will work as defined by the user in the Set up Sampler Options section 3 4 4 MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 57 109 5 SAMPLE ANALYSIS REF M22AL UM EN 004 NOTA To perform an emergency stop in case of any problem push briefly on the on off button and see section 98 5 2 NOTA The analysis can start as soon as the working temperature is reached about 20 min at 23 C room temperature This prompt means This prompt means that that the temperature the temperature setting setting of the F of the enclosure and or enclosure and or the the reagent is reached reagent is not reached E yet 5 6 7 3 Unloading The racks are unloaded from the sampler automatically NOTA Never breach the exit of a rack otherwise the sampler will stop in emergency See section 9 5 2 to restart the sampler The rack can be re used to load new samples To remove each sample put the rack on the table and push on the bottom of the tube then take it by the cap Page 58 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 5 SA
84. ng module Next remove the tubing fixed on the RBC counting head located on the right side of the counting module Leave the sheath on the tubing Remove the tubing fixed on the plastic fitting located under the stainless tube from WBC counting block Leave the sheath on the tubing MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 99 109 9 SERVICE REF M22AL UM EN 004 Remove all connectors The counting bath module can now be handled to carry out the required operations of replacement REASSEMBLY PROCEDURE To reassemble the unit carry out the various operations in the opposite direction Do not forget to put the sheaths back on the tubing 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 in order not to wound it Page 100 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 9 SERVICE 9 4 5 Aperture block replacement Wear rubber gloves and wash hands with a disinfectant after completion of work Befo
85. ng the opening of the door close it switch off the AL and call Orphee representative The barcode reader is a laser CLASS II never dismantles the cover in case of problem call Orphee s representative Page 60 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 5 SAMPLE ANALYSIS Press YES in the prompt to allow the needle go down Open the door if this prompt appears This prompt appear if the STARTUP has not been done Run a STARTUP see section 5 4 otherwise a message Startup not done will be printed on all results print Introduce the tube of the blood sample without cap under the needle Press YES in the new to launch the analysis cycle The green LED becomes red the tube can be removed only when the needle is up A new cycle can be started again when it becomes again green return to section 5 6 7 to identity the sample As soon as the cycle is launched the SID is automatically incremented and thanks to its data processing multitasks the MYTHIC 22 AL is available for the identification of the following sample See section 5 6 7 After running the samples close the door by pushing the top of the door Previous SEEN Toos EE The results of the analysis are sent before the cycle is finished to be checked at the same time as the printer NOTA It is not necessary to wait for the end of the result printout to launc
86. nique 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 Aperture Electrode Detection area Proportional height to the cell volume Sn Se ER Voltage impulse et the electrode terminal Counting Impulse Page 76 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 8 TECHNOLOGY 8 1 2 Five part diff measurement The innovative optical detection system is covered by two pending patents 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 samples 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
87. ns done in one or several boxes Once a modification is done this prompt allows to save press YES or not press NO the modification Means an ERROR occurred it WARNING You have to INFORMATION window no is mandatory to do the action confirm or not the action action required described in the window or in described in the window the table section 9 6 MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 85 109 8 TECHNOLOGY REF M22AL UM EN 004 8 7 2 Menu tree Launch new menu Launch Mechanical action Entry menus View Results START UP Blank Cycle SHUT DOWN End of day Cyde CHECK VALVES CHECK FLUIDICS waste primeatt CYCLESCOUNTER LOGERRORS H CHECK SENSORS roo on RUN NEEDLE Page 86 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 9 SERVICE 9 SERVICE The quality of the results and the reliability of the MYTHIC 22 AL 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 been adequately trained to wear rubber g
88. ntact Orphee S A service department or your Orphee s representative 4 Previous screEN TOOLS MENU STATUS 30 04 19 00 Place the USB key with the new software in the USB connector at the rear of the MYTHIC 22AL Press to load the new software version The different prompts hereafter appear to help you during the loading Select the software version to load and press LOAD Press EXIT to exit of the prompt without action The current software version will be definitively erased and replaced by the new one Press yes only if you are sure you want to load a new version software This prompt appears to confirm the version has been successfully loaded This prompt appears when the release of the software has failed MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 37 109 4 SPECIFICATIONS REF M22AL UM EN 004 4 SPECIFICATIONS 4 1 ANALYTICAL SPECIFICATIONS Throughput Close tube mode gt 40 samples hour Other vial mode gt 45 samples hour Sampling Volume 18 2 ul Nominal volume inside the needle the total volume could be upper according to 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 fo
89. on 9 1 4 and the pump operation DRAIN BATH DEFAULT check the tubing connection of the fluidics VACUUM COUNTING DEFAULT perform a piston greasing see section 9 1 3 and check the tubing connection of the fluidics SYRINGE VACUUM perform a piston greasing see section 9 1 3 and check the tubing connection of the fluidics MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 103 109 9 SERVICE REF M22AL UM EN 004 SAMPLER No Barcode reading Wait for the end of the in progress cycle then open the front door and clean the mirror see section 9 1 5 Non loading of a rack Proceed as stated hereafter for all prompt starting with LOADER Erkon Check if the rack is in the good loading position and if the round label and the barcode label are present and clean see section 5 6 6 2 If the problem remains call your Orphee s representative Rack blocked Proceed as hereafter for all prompt starting with TRANSFER Perform a SYSTEM INIT MENU SERVICE if the problem remain call your Orphee representative Rack blocked during the ejection Proceed as stated hereafter for all prompt starting with EJECTOR Remove all the racks present on the unloading part then run a SYSTEM INIT MENU SERVICE if the problem remains call your Orphee s representative Mixer blocked Proceed as stated hereafter for all prompt starting with MIXER Perf
90. 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 wavelength Passive sheath Injector Sample LIGHT INTENSITY WBC CELL OPTICAL DETECTION AREA TIME SAMPLE FLOW ALL For each cell throwing the optical detection area two pulses are generated one for the Axis Loss Light ALL measurement and one for the Forward Side SCatter FSC measurement The result of those two axes of measurement is the high definition matrix that enables to identify five WBC populations FSC MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 77 109 8 TECHNOLOGY REF M22AL UM EN 004 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 EOSINOPHILS ALL NEUTROPHILS BASOPHILS T 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
91. ood can be altered before 20 samplings A volume of insufficient blood for the quantity of anticoagulant may involve an erroneous result 5 5 2 Blood sample collection tube The following table shows the type of sample collection tubes available with the MY THIC 22 AL The use of another type of sample collection tube may destroy the sampling needle or give false results please contact your Orphee s representative before using this different type The more important close tube characteristics are the length and diameter for the tube holder the cap which contains the rubber membrane for the piercing module The close tubes serial numbers below are showed only as examples please contact your tube vendor for more details about EDTA and VACCUM contain The minimum volume of blood required in the sample tube is 300 1 BD VACUTAINER 368861 13x75 BD VACUTAINER 368452 13x75 BD VACUTAINER 367651 13x75 BD VACUTAINER 367652 13x75 TERUMO VENOSAFE VFO54SDK 13x75 GBO VACUETTE 454034 13x75 GBO VACUETTE 454024 13x75 GBO VACUETTE 454087 13x75 GBO VACUETTE 454023 13X75 GBO VACUETTE 454036 13x75 The SARSTEDT tube request a special optional rack type O2 see section 5 6 6 1 please contact your Orphee s representative for its supply Page 52 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 5 SAMPLE ANALYSIS
92. orm a SYSTEM INIT MENU SERVICE if the problem persists open the front door see section 5 6 8 and check if the mixer can move easy from top to low position nothing as tube should breach the movement then close the door and perform a SYSTEM INIT MENU SERVICE if the problem remains call your Orphee s representative Rack is ejected directly without The barcode of the rack is missing or altered check the quality of the blood sampling label and change it if necessary NOTA In any case of problem generated by the printer read the printer s operator s manual PRINTER No printing Check if the printer is selected see section 3 3 Check the paper level Check the electrical connection Bad printing Check the ink ribbon or the ink cartridge Page 104 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 9 SERVICE 9 6 TROUBLESHOOTING MESSAGE This section allows knowing what to do when a troubleshooting message appears on the screen If the problem remains contact your Orphee s representative MESSAGE ACTION BACKUP FOLDER NOT FOUND BACKUP MEMORY IS ALMOST FULL PLEASE DELETE RESULTS CYCLE VALVE X FAILED DILUENT ALMOST EMPTY SID ALWAYS MANDATORY INTERN COUNT ERROR Re start the Mythic Re start the Mythic Delete the calibration results Check if the USB thumb drive is connected to the analyzer Re start the Mythic File
93. ors 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 AL requires continued operation during power mains interruptions it is recommended that the MYTHIC 22 AL 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 MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 5 109 REF M22AL UM EN 004 Guidance and manufacturer s declaration Electromagnetic immunity The MYTHIC 22 AL is intended for use in the electromagnetic environment specified below The customer or the user of the MYTHIC 22 AL should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance Electromagnetic environment guidance level Portable and mobile RF communications equipment should be used no closer to any part of the MYTHIC 22 AL including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommen
94. perform a cleaning of the aperture blocks and the flow cell with the cleaner Pe BACKFLUSH APERTURE coe To perform a back flush in the aperture blocks pr BACKFLUSH OPTICS OPTIES To perform a back flush in the flow cell To have access to this cycle press SERVICE from the MAIN MENU then press TROUBLESHOOTING NOTA TECHNICIAN is only available to the Orphee s service people Copyright Orphee SA All Rights Reserved The function of each button is described in the sections hereafter 9 3 1 to 9 3 5 MYTHIC 22 AL REF M22AL UM EN 004 9 SERVICE 9 3 1 Sampler 04 08 17 32 4 PREVIOUS SCREEN TOOLS 9 3 2 Check sensors 4 PREVIous SE TOOLS MENU STATUS 28 06 20 38 FLUIDIC DOOR TRANSFER FRONT DOOR 55 e WBC g e HOME SERINGUE 1 PLT RACK DETECTION 1 EJECTOR FSC FLAP DOOR e MIXER ALL EJECT COVER e LOADER LE ALE PX EJECT FULL e HOME NEEDLE HOME ROCKER REAR ENCLOSURE CLEANER 9 3 3 Check valves 4 rev SE STATUS 01 05 12 09 MYTHIC 22 AL NOTA To understand the function of each button we recommend to follow an Orphee s training Copyright Orphee SA All Rights Reserved This screen allows checking if the different sensors are available in case of problem NOTA To understand the function of each sensor we recommend to follow an Orphee s training Range of trigge
95. pler Options Two modes are possible 1 Barcode exclusive this mode allows the maximum security because only the tubes with a barcode label and read by the MYTHIC 22AL are run no error is possible 2 Barcode and RAC POS If the barcode label is not present or in case of non reading the sample is run and its result is identified by the RAC POS Security rules 1 SID is mandatory 2 SID is unique for a patient in a work list 3 RACPOS is always unique for the order To do T in the column amp Status 4 If an order is rerun it is duplicated in the work list 5 Nothing can be changed when the run is in Progress P in the column E Status 6 When an Order is Done D the column E Status only the test and the RACPOS can be changed for the rerun in rack or needle mode 7 When a rack is finished and in case of sample tubes missing in the rack the orders corresponding become Unmatched U in the column E Status Association rules 1 Once a sample is analyzed the result is associated with its order if the result cannot be associated an order with AUTOSID with an incremental number initialized at each beginning of day is automatically generated see section 3 3 to set up the number 2 The results are never matched with in progress P or unmatched U order 3 Incase of manual match performed by the operator the letter M will appear on the printout MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 53 109
96. r its DC adaptor and to protect it from overheating these openings must never be blocked or covered Do not place this apparatus or its DC adaptor near or over a radiator or heat resistor or where it is exposed to direct sunlight Do not place a vessel containing liquid on this apparatus and its DC adaptor as this can result in a risk of fire or electric shock Do not expose this apparatus or its DC adaptor to rain or place it near water If this apparatus or its DC adapter accidentally gets wet unplug it and contact your service center immediately Make sure to pull out the power cord from the outlet before cleaning Do not overload wall outlets extension cords or adaptors beyond their capacity since this can result in fire or electric shock Do not use travel power adapter Power supply cords should be routed so that they are not likely to be walked on or pinched by items placed upon or against them Page 2 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 To protect apparatus or its DC adaptor from a lightning storm or when it is left unused for long periods of time unplug it from the wall outlet This will prevent damage to the set due to lightning and power line surges Before connecting the AC power cord to the DC adaptor outlet make sure the voltage designation of the DC adaptor corresponds to the local electrical supply Never insert anything metallic into the open parts of t
97. r temperature Ambient 17 C lt gt 35 C Enclosure 32 C lt gt 40 C Reagents 34 C lt gt 45 C The four buttons located at the bottom of the screen allow checking the HB led the optical led the aperture current and the pump For testing press the button check the function then press again the button For testing the valve press the dedicated button to switch the valve on then press again to switch it off At each pressing a click noise can be heard if nothing is heard call an Orphee s representative Page 93 109 9 SERVICE REF M22AL UM EN 004 9 3 4 Check motors fluidics Each motor of the fluidics part is tested during a short cycle If one or several motors are in default the associated prompts will be displayed In case of problem call your Orphee s representative 9 3 5 Log errors 4 Previous screEN TOOLS STATUS 04 05 17 47 DATE _HOUR ERR ERROR 001 01 06 04 15AM 001 xxx 002 02 06 12 33PM 002 ERRSYSIO 003 03 06 08 51PM 003 ERRLINK 004 04 06 04 09AM 004 INTERN NO MEMORY AVAILABLE 005 05 06 12 27PM 005 ERRRTCIO 006 06 06 08 45PM 006 ERREEPROMIO 23 i i 171 imi 06 86 08 APM 006 en This screen allows visualizing the date and timing when an 008 08 06 12 21PM 008 ERRBADPARAM IS RE H 009 09 06 08 39PM 009 EFRADSSOIO error has occurred as well as the code and the origin of this 010 10 06 04 57AM 010 ERRAD5308IO error
98. ral disposal legislation If any doubt call an emergency center MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 43 109 4 SPECIFICATIONS REF M22AL UM EN 004 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 particles Violet dye Clear aqueous solution violet color with characteristic smell At room temperature until expiry date labeled on the bottle may 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 water seek for medical advice in case of persisting symptoms Accidental release and disposal measures Person related safety precautions Wear protective equipment keep unprotected persons away Environmental protection Do not allow product to reach se
99. re 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 tool provided in the maintenance kit unscrew the screw and remove the connection NOTA This operation can be performed without dismantling the complete bath block Unscrew the aperture block a quarter of turn Remove the o ring and replace it by a new one or replace the whole part NOTA The WBC aperture block is marked with a figure 8 on the ear and with a figure 5 for the RBC Do not grease the aperture o ring REASSEMBLY PROCEDURE To reassemble the unit carry out the various operations in the opposite direction Place the seal on the aperture block gently in order not to wound it MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 101 109 9 SERVICE REF M22AL UM EN 004 9 5 TROUBLESHOOTING OCCURENCES In any case if a problem is not solved call your Orphee 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 No 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 f
100. rry out the various operations in the opposite direction Place the seal on the needle gently in order not to wound it Do not grease the needle after removing If the needle is greased the grease could block the grooves and create diluent leak and the results would be altered MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 97 109 9 SERVICE REF M22AL UM EN 004 9 4 3 This procedure must be carried out to replace the bath seals on the manifold or the aperture seals Baths dismantling Wear rubber gloves and wash hands with a disinfectant after completion of work 4 Previous SE TOOLS MENU STATUS 30 04 18 16 START UP From the MAIN MENU press SERVICE QUALITY CONTROL e DISPLAY RUNS RESULTS SHUT DOWN CALIBRATION OP LOGOUT PREVIOUS SCREEN TOOLS STATUS 25 02 10 59 SYSTEM INIT CLEANINGS FLOW CELL CLEANING BACKFLUSH APERTURE BACKFLUSH OPTICS TROUBLESHOOTING DRAIN ALL RINSE ALL LUBRIFICATION POS REPEATABILITY Then press DRAIN ALE The WBC bath will emptied BLEACH To remove the counting bath module pull the clip 1 while pushing the top from the counting bath towards the inside of the machine 2 Page 98 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 9 SERVICE Then upwards raise the counti
101. run indicates the number of samples runs you can perform calculated with the smaller volume of reagents VALID AUTONOMY CBC run AUTONOMY DIF run MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 19 109 1 INSTALLATION REF M22AL UM EN 004 System priming 4 PREVIous SE TOOLS STATUS 30 04 18 16 START UP SHUT DOWN OP LOGOUT PREVIOUS SCREEN TOOLS STATUS 23 02 10 25 DILUENT CYCLES COUNTER PREVIOUS SCREEN TOOLS STATUS 23 02 10 25 Page 20 109 Copyright Orphee SA All Rights Reserved The main menu is displayed Press on l es NOTA To do an emergency stop in case of D push briefly on the on off button Press BCE e 22 AL performs a complete priming cycle AUTONOMY run indicates the number of samples runs To prime or to know the quantity of reagent press the dedicated button CYCLES COUNTER Press to display the cycle counters To reset the counter with the button RESET please contact your Orphee s representative MYTHIC 22 AL REF M22AL UM EN 004 1 INSTALLATION DILUENT PRIME STATUS 23 02 10 40 PREVIOUS SCREEN TOOLS VALID CHANGE REAGENT PRIME DILUENT LYSE AND CLEANER PRIME Proceed as described above for the diluent WASTE PREVIOUS SCREEN TOOLS STATUS 23 02 10 41 VALID ESCAPE UNDO DILUENT From the MAIN MENU pre
102. se of use of local blood controls or national hematology survey a difference can be observed on the WBC results This is done by the measurement techniques used in the MYTHIC 22AL The WBC can be lower than the expected results Result obtained on a normal FRESH blood Others cells Lymphocytes Electrical threshold FSC The number of WBC is done by counting all the cells in the curve between the electrical threshold to the end of the curve The left peak is the lymphocytes and the right peak all the others WBC cells Result obtained on a CONTROL blood Electrical threshold FSC For a control blood in order to allow to have the lymphocytes in the lymphocyte area in the scattergram the manufacturer of the control bloods must use smaller fixed cells which appears for the lymphocytes under the electrical threshold on the WBC curve and therefore are not considered The use of smaller cells is necessary because the fixation of the membrane increase the measurement of the FSC signal The fixed membranes of the cells give a more important deviation of the light beam compare to the same membranes without fixation It is well known in cytometry than the use of fixed cells increase the FSC signal It appears therefore evident that regarding a control blood the resistive WBC counting is lower than the real number of cells inside the control blood The local blood controls manufacturers or national hematology survey providers mu
103. secsesssssecussucsucsessesseessesseucescancaneaeeasess 5 5 1 Blood collection x Js de is 5 0 2 Blood sample collection TUbe EE EEEE AEEA ER PERDU e He Ue e na nn md nent 5 6 ANALY SIS scs d RR RR RR OR RR RR D 6 1 MR rere lll Rep D 6 2 Working rules delete be ebat ibd v dees bee asd epe epe dte eate dee Eee D 6 3 EOD GRO GRE de 564 5 6 OLIEN E ecc De T MEDICAE 5 6 7 Run Rack 5 6 8 STAT or other vial Sample Identification reete e ete edat eere e eer 59 5 6 9 STA Tor other vial Sample TUN noiiire nl den RER le 60 DTA DISPLAY RUNS nn ns lle 61 5 8 PRINTING Gd CENTRE Yr tenen Ven ne NT NN EN ERE CERE PCR VR NE Ne EE TA P te Vera eve tu eed 63 5 8 1 PCE3 EX 300 USB model report eoe Oe e RO RR de ec e E RT b CREDE RM eles 63 5 81 PCL6 model report 5 9 LOGS INTERVENTIONS RR UR EROR RORUR RR RU RRORE UR ASL ERU RR ORT E Een 5 10 5 10 1 Results 5 10 2 View HAL STAND BY AND SHUTDOWN oiua aeoieo ee ete et ee lec ec t tiber to et bett Ne 68 QUALITY CONTROL eda yo ns dee rose nee tn ee ne tem en des dtes bte m ae dettes 69 6 1 INTRODUCTION natation E RV CERE both Le E EE bb e vec ve a EL a vei 6 2 QUALITY CONTROL m ess m yer
104. ss then to have access to this screen Enter lot number the expiry date and the container capacity Press to validate the new entry or after changing a new container with the same information If needed enter the container volume in milliliter After the replacement of a new container or to prime the PRIME DILUENT diluent press new entry is automatically done in the logs see section 5 9 To validate or not the modification see section 8 7 1 Only enter the capacity of the container After replacement of the waste container press RESET to initialize the waste calculation To validate or not the modification see section 8 7 1 1 6 TRANSPORTATION AND STORAGE Before transportation outside the laboratory perform a complete cleaning with a disinfectant in compliance with the local regulations Storage temperature 10 C to 50 C If the MYTHIC 22 AL has been stored at a temperature lower than 10 C it must be left at room temperature during 24 hours MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 21 109 2 GENERAL OVERVIEW REF M22AL UM EN 004 2 GENERAL OVERVIEW 2 1 INTENDED USE The MYTHIC 22 AL is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories by an authorized and trained people Only human blood or artificial blood recommended control or calibrator should be run Only the reagen
105. st be informed of this limitation MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 79 109 8 TECHNOLOGY REF M22AL UM EN 004 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 lt MCHC b Cold Agglutinin MCHC gt MCHC h RDW Red blood cells Distribution Width Anisocytosis 1 RDW gt RDW h1 Hematocrit HCT is measured by integration volume of all of the red blood cells which flow in the RBC counting chamber aperture MCV is obtained by calculation following the formula MCV 10 RBC The RBC distribution curve analysis allows the measurement of RDW RDW is an expression of the standard deviation divided by MCV This parameter evaluates the RBC 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
106. stics calculations are shown at the bottom of the display and are automatically done after each run The column SEL allows selecting or unselecting a result the statistics are done only with the selected results TOOLS The key allows doing the following actions o PRINT Print the table o SEND Send the results o DELETE ALL Delete all the results DELETE ALL o SAVE Save the results in USB key Press to exit the prompt without action Page 72 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 7 CALIBRATION 7 CALIBRATION The calibration of the MYTHIC 22 AL should be carried out only if the QC carried out on a blood control used according to the recommended conditions is significantly out of the limits see section 6 Orphee recommends using the following calibrator Myt Cal code number MY TCAL2 The calibration blood must be used before its expiry date It should be mixed and stored in accordance with the instructions of use recommended by the manufacturer 4 FEV E TOOLS MENU STATUS 30 04 18 16 START UP QUALITY CONTROL e HORKLIST DISPLAY RUNS SHUT DOWN CALIBRATION RESULTS To reach the screen Calibration press the key 212381 from the main menu OP LOGOUT 4 PREVIous screEEN TOOLS MENU STATUS 16 04 15 22 This menu sends the following information o Lot
107. such as re orienting or relocating the MYTHIC 22 AL Over the frequency range 150KHz to 80MHz field strengths should be less than 3V m Page 6 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 C 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 connected Consult the dealer or an experienced radio TV technician for help The user may find the following booklet prepared by the Federal Communications Commission helpful How to identify and Resolve Radio TV Interference Probl
108. t Orphee or its representative will not apply any warranty on this power supply and on the instrument Please contact Orphee or its local representative before using such material 1 4 PRINTER CONNECTION Connect the printer cable in conformity with the printer user s manual Use ONLY the rear USB plug of the MYTHIC 22 AL to connect the printer cable Select the printer driver section 3 3 MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 17 109 1 INSTALLATION REF M22AL UM EN 004 1 5 CONNECTION CHANGE AND PRIMING REAGENTS MYTHIC 22 AL works exclusively with the reagents described in section 4 3 Orphee or its local representative will not be responsible for the quality of the results and for the maintenance of the instrument if other commercial reagents are used 1 5 1 Connection Lytic reagent and cleaning solution Before handling the reagents read carefully their specifications described in section 4 3 and check if their shelf life dates are not reached Remove the door on the left side of the instrument Put the reagent bottles into the dedicated location Remove the caps of the bottles Tighten the red caps on the OnlyOne bottle red sticker and the blue one on the cleaning solution bottle blue sticker Diluent and waste Connect the diluent tube male connector on the outlet on the bottom and tighten the cap on the diluent conta
109. t rt ne e to e ar Ee ER e eere o eee ree o NOAE 2 GENERAL OVERVIEW gt o isco oa eens e EA ed bos net de du donna RM RENE Led A TRES TINTENDED USE An NN Re T do tcn E ta E d rM Eo foto E ta lad o ooo NE 2 2 GENERALITIES tatit tre tab da asc e Ob av wa aw a ca abo eate tabe vai a cte eraat da inv 253 TOVERVIEW E 2 4 MAINPART DESCRIPTION vite vata v a CHRONO Ceo rato tte n MC za MEI AT 2 42 Dil tion fl idic part iioi een eto ire e e OR bI IR COE I re t 2 453 Power Supply Block iie eed e vede n ete E ech reta eed eee teda a ve tede 24 4 Reagetnt ACY Encres SR nm ane LE Ham up M 3 INSTRUMENT SET UP LL d RE 3T USERS TDENTIEICA TION ovre ttn oer PUE RENE TRE D VI PEU inner EE EE TEE PRAET VP EU inner 314 Starr Wp Machine reete tee rete sd beens eee o ecl a bete 3127 JImphoGess eee li entente ten enr dede 3 2 SYSTEM STATUS s RR RR READ RR ER RERO REANO RR RETRO 9 9 SET UP lee nef ne ie balada b aU pd ebd ird R 3 4 ADVANCED SET UP o eet etim n rt ntn te anat n dta 3 41 Sampler option si us E 79 A 3 41 Analysis options s ven edepol nn a ee e Rote esee eai eee 30 3 4 2 EADS parameters SR AEE DENEN S D D M E
110. ted CBC or DIF Male or Female or Unknow Date of the blood drawing Time of the blood drawing Prescriptor Origin of the sample Comments TOOLS Press on to delete all delete the selected order print or save in internal memory the complete worklist RESTORE allows to load a worklist from an USB key and BACKUP allows to save the worklist into an USB key Page 54 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 5 SAMPLE ANALYSIS 5 6 4 Modify an order 4 0 SE TOOLS STATUS 21 04 17 21 VALID sib PID PO0007 ID MARTIN JLP BIRTH GENDER fe TEST DRAW DATE DRAW TIME TYPE BRION NOTE 12 RACK PAT COMMENT 5 6 5 New Order 4 Previous SE TOOLS MENU STATUS 15 04 20 16 RACK TyPe Number Posi t ion VALID NNNM DO Dan BS CET r Be TYPE BIRTH DRAW DATE DRAW TIME 4 PREVIous SE TOOLS STATUS 28 06 19 21 WORKLIST RUN NEEDLE STOP RACK MYTHIC 22 AL Copyright Orphee SA All Rights Reserved NOTA A patient order can be modified until the blood is drawn Select the box and enter the modification with the keyboard To validate or not the modification see section 8 7 1 To run this patient in STAT mode or open vial mode press I zz adl see section 5 6 8 To come back to the work list press EEE or
111. ted cleaning see the following section 9 1 2 Shut down or concentrate cleaning see section 5 11 Cover cleaning Clean the cover above and around the sampling needle with a wet paper with a disinfectant to eliminate the blood trace Piston greasing see section 9 1 3 In line filter cleaning see section 9 1 4 Barcode cleaning see section 9 1 5 Needle o ring replacement see section 9 4 2 MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 87 109 9 SERVICE REF M22AL UM EN 004 9 1 2 Concentrate cleaning This cleaning is necessary once a week to clean the WBC bath or when MYTHIC 22 AL is in permanent rejection for at least one measured parameter or permanent clog flag see section 8 1 5 Prepare a Sodium Hypochlorite solution at 12 in chloride diluted 4 times with distilled water if sodium hypochlorite is concentrated at 48 in chloride or three times with 36 4 PREVIous screen TOOLS MENU STATUS 30 04 18 16 START UP Return to the main menu MENU Then press QUALITY CONTROL e WORKLIST DISPLAY RUNS CALIBRATION RESULTS SHUT DOWN OP LOGOUT 4 Miu E TOOLS STATUS 01 05 11 18 BLEACH Press Wa t for the prompt then Open the door on the right side by unscrewing the two quarter turn screws with the key provided in the kit Open completely the door then lift it to remove Page 88 109 Copyright Orphee SA
112. the display and are automatically done after each run The column SEL allows to validate or to unselect a result RUN NEEDLE CALIBRATION To calibrate see the following section hereafter NOTA The results of the analyses performed on one calibrator during the same day remain in the memory and are used for calculations if they are selected 7 1 2 Calibration Before starting the calibration unselect the results you do not wish to use for the calculation of the calibration See below section 7 1 1 4 Previous scREEN TOOLS MENU STATUS 61 05 11 51 From the previous menu the key CALIBRATION or TOOLS RBC HGB HCT allows e To calibrate with the selected results e delete the results Press e Toprint the results Press see below the print report To calibrate one or more parameters e Select the parameter E E z e Press the key To exit without action press RUN NEEDLE CALIBRATION Page 74 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 7 CALIBRATION Model of print out calibration report CALIBRATION IN PROGRESS PRINTED ON 19 06 2004 15 50 00 BY BILL COEFFICIENTS 1 6888 1 000 1 000 1 000 1 000 LOT cs224 CREATED ON 1871272003 BY BILL EXPIRY 0670172004 WBC RBC HGB 1 PLT TARGETS 9 51 4 25116 5146 9 37 5 LIMITS 1 01 8 241 8 5 E 1 25 COEF 1 81 1 8 1 8 MERN
113. the case of use of local blood controls or national hematology survey a difference can be observed on the WBC result This is done by the measurement techniques used in the MYTHIC 22AL See the section 8 2 2 6 2 QUALITY CONTROL MYTHIC 22 AL stores in memory up to 100 results per lot for 12 different lots Results of each lot can be viewed in tables and Levey Jennings graph 4 PREVIOUS SCREEN TOOLS MENU STATUS 30 04 18 16 START UP Press tse to have access to the quality control menu QUALITY CONTROL e WORKLIST DISPLAY RUNS CALIBRATION RESULTS SHUT DOWN OP LOGOUT 4 PREVIous SE MENU STATUS 16 04 15 52 Quality control display presents the identification of the lots The last active lot is labeled with a dark dot on the left lot To choose another lot press on the required lot The key allows the modification of the identification and the target values The key allows restoring the data from an USB key The key allows To view the result table To perform quality control analysis CHANGE RESTORE RESULT MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 69 109 6 QUALITY CONTROL REF M22AL UM EN 004 B Previous screen TooLs nee To print or send the targets results and graphics press Tag the lot number to select then press the appropriate button o PRINT TARGETS print the targets o PRINT RESULTS print the results o PRIN
114. the printer or invalidate the printings Switch on the printer or invalidate the printings Delete data on the selected directory Modify the value Select the right driver compatible with the Mythic Switch on the printer or invalidate the printings Switch on the printer or invalidate the printings Switch on the printer or invalidate the printings Add some paper Perform a clean cycle Re start the Mythic Re start the Mythic Re start the Mythic Re start the Mythic Press OK The instrument is ready to work You have to be logged with the good access code Perform a start up cycle Perform a new start up cycle Call an Orphee s representative System is resetting after the version is released Re start the Mythic Page 106 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 9 SERVICE MESSAGE SYSTEM FATAL ERROR DIRECTORY DOES NOT EXIST THUMB DRIVE IS FULL TOO MANY FILES OPENED VERSION RELEASE FAILED THE CHOSEN RELEASE IS NOT COMPATIBLE WITH THE MYTHIC 22 AL SYSTEM DIRECTORY DOES NOT EXIST TOO MANY FILES OPENED VERSION RELEASE FAILED THE CHOSEN RELEASE IS NOT COMPATIBLE WITH THE MYTHIC 22 SYSTEM WASTE ALMOST FULL ACTION Re start the Mythic Re start the Mythic Room temperature out of range 18 or gt 34 Replace the bottle and perform a prime Cleaner Replace the container and perform
115. 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 SWITCHED ON THE BARCODE READER IS A LASER CLASS II NEVER DISMANTLE THE COVER IN CASE OF PROBLEM CALL ORPHEE REPRESENTATIVE MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 15 109 1 INSTALLATION REF M22AL UM EN 004 1 2 INSTALLATION CONSTRAINTS 1 2 1 Installation place To ensure that the MYTHIC 22 AL fulfills its function place the instrument on a table which supports the weight of the instrument printer and reagents 40 Kg Leave a space of 10 cm at the rear of the instrument to ensure a well ventilated place Avoid a place that can be exposed to direct sunlight 1 2 2 Installation environment a Indoor use b Altitude up to 3 000 m see NOTA hereafter c Temperature 18 C to 34 C d Maximum relative humidity 80 for temperatures up to 31 C decreasing linearly to 50 relative humidity at 40 C e MAIN supply voltage fluctuations up to 10 of the nominal voltage f Transient over voltages typically present on the MAIN supply g Rated pollution degree IT Please contact Orphee s representative if you want to use the instrument in special conditions altitude higher than 2000 m or special power supply conditions NOTA 1 3 ELECTRICAL CONNECTIONS 1 3 1 Rear
116. tion TMCV LHCT 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 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 a decrease in the result which is sample dependent MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 45 109 4 SPECIFICATIONS REF M22AL UM EN 004 Parameter Specimen Occurrence Possible Indication of Error on MYTHIC 22 AL action LYM amp Nucleated RBC Erythroblastosis Platelet aggregation Indication NRBC may be detected on the
117. ts mentioned in this manual are permitted to be used The optimum performances can be only achieved if the cleaning and maintenance procedures are carefully followed see section 9 1 2 2 GENERALITIES MYTHIC 22 AL is a fully automated analyzer performing hematological analysis on whole blood collected on EDTA K2 or K3 tubes Sampling volume 18 2 pl inside the needle the total volume could be upper according to the blood remaining outside of the needle Two sampling modes closed tube in 10 racks of 5 tubes opened other vial in a special position front door open Throughput close tube mode gt 40 samples hour Other vial mode gt 45 samples hour 22 analysis parameters in DIF mode and 12 parameters in CBC mode Leukocyte parameters WBC White Blood Cells LYM Lymphocytes in amp DIF mode only MON Monocytes in amp DIF mode only NEU Neutrophils in amp DIF mode only EOS Eosinophils in amp DIF mode only BAS Basophils in amp DIF mode only Erythrocyte parameters RBC Red Blood Cells HGB Hemoglobin HCT Hematocrit MCV Mean Corpuscular Volume MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration RDW Red Blood cells Distribution Width Thrombocyte parameters PLT Platelet MPV Mean Platelet Volume PDW Platelet Distribution Width PCT Thrombocrit For Investigation Use only in the United States of America Page 22 109 Copyright Orphee SA All R
118. ur times for each level PARAMETERS RANGE LIMITS the larger WBC 10 mm O to 100 0 4 or 4 RBC 10 mm 0 1 to 8 0 07 or 3 H6B g dL 1 0 to 24 0 3 or 2 HCT 5 to 70 2 or 3 PLT 10 mm 5 to 2 000 10 or 5 Reportable range Within the reportable range the results are flagged with a D to indicate that it is necessary to re dilute and re run the sample PARAMETERS REPORTABLE RANGE WBC 10 mm 100 to 150 RBC 105 mm 8 to 15 75 70 to 80 PLT 103 mm 2000 to 4 000 Repeatability Calculated with 20 runs of a fresh whole blood sample performed a commercial MYTHIC 22 AL PARAMETERS CV RANGE WBC lt 25 gt to 6 0x10 mm LYM 5 gt to 15 MON lt 10 gt to7 NEU lt 4 gt to 50 EOS lt 10 gt to 5 BAS lt 40 gt to 2 RBC 2 gt to 4 0x105 mm HGB lt 15 gt to 12 0 g dL HCT lt 2 gt to 40 0 MCV 176 to 85 fL RDW lt 4 gt to 14 PLT 5 gt to 250x103 mm PMV 3 gt to 8 fL Calculation method Page 38 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 4 SPECIFICATIONS Carry Over For each parameter 3 runs are performed from a high concentration sample followed by 3 runs without sample WBC RBC HGB PLT High con
119. ve Each column is identified by its date To print or save the log report press Select to print or save the logs of the number of pages indicated on the screen To print or save the logs of one or more days select COMO then enter the starting day and ending day MYTHIC 22 AL Copyright Orphee SA All Rights Reserved Page 65 109 5 SAMPLE ANALYSIS REF M22AL UM EN 004 5 10 ARCHIVE MYTHIC 22 AL can save more than the last 1500 patients with results alarms distribution curves in the internal memory and up to a maximum of 60 000 results in a memory stick USB key of 512 Mbit or more see section 3 4 7 4 FEV SE TOOLS MENU STATUS 30 04 18 16 START UP QUALITY CONTROL Press SOE to enter the archive display WORKLIST DISPLAY RUNS SHUT DOWN CALIBRATION RESULTS OP LOGOUT 5 10 1 Results The Archive display allows viewing the results of the 4 PREVIOUS SCREEN TOOLS STATUS 16 06 16 24 analysis Each result is saved in a work list of the day The first column gives the name of the different parameters the first line the result number The results of the patients are given in column A value in bold means out of the normal limit and a value in white on black mean rejection At the bottom of the display under the table are the demographic data of the selected result The buttons D 3X1 located under 1D c EM ee
120. wage 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 44 109 Copyright Orphee SA All Rights Reserved MYTHIC 22 AL REF M22AL UM EN 004 4 SPECIFICATIONS 4 4 ANALYTICAL LIMITATIONS 4 4 1 MAINTENANCE Please respect the maintenance procedure and the quality control procedure Otherwise results may 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 Recommendations 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 In the case of use of local blood controls or national hematology survey a difference can be observed on the WBC result This is done by the measurement techniques used in the MYTHIC 22AL See the section 8 2 2 4 4 2 Interferences Parameter Specimen SCENE action P Possible Indication of Error on MYTHIC 22 AL Cause high IgM level may lower RBC and increase C wec cold Acautitin MCV Seek for red cell clumping Nucleated RBC Erythroblastosis Unlysed RBC Cryoglobulins Platelet aggregation Indica
121. y determining hemoglobin content of blood samples on MYTHIC 22 AL 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 A clear pale yellow aqueous solution with slight characteristic smell composed of alkaline salts inorganic buffers leukoprotective agents detergents a non toxic hemoglobin stabilizing chelate and preservatives NOTA This reagent does not contain any cyanide neither formaldehyde nor azide Storage At room temperature until expiry date labeled on the bottle Precautions May 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 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 fede

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