Do not use the MYTHIC 22 if it is not working properly, or if it has suffered any damage ( damage to the supply cord or its plug; damaged caused by dropping the power supply adapter).
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This equipment needs special precautions regarding general requirements for safety. Guidance and manufacturer’s declaration – electromagnetic emissions. The MYTHIC 22 is intended for use in the electromagnetic environment specified below. The customer or the user of the MYTHIC 22 should assure that it is used in such an environment.
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RF transmitters, an electromagnetic site survey should considered. If the measured field strength in the location in which the MYTHIC 22 is used exceeds the applicable RF compliance level above, the MYTHIC 22 should be observed to verify normal operation.
- The optimum performances can only be achieved if the calibration, controls check, cleaning and maintenance procedures are carefully followed If the MYTHIC 22 has been stored at a temperature less than 10°C it must be left at room temperature during 24 hours.
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050-1001-01 150 24 European Power line cord 150-2001-CEE C13 1000 5/10-20L Adaptator 300-1009-05 1020 M22C User manual MYTHIC 22 Installation Report MYTHIC 22 Quality Control Certificate Screwdriver Slot 1/4" 700-7101-02 MAINTENANCE KIT Box 18/22 Designation Part Number Tygon tubing 1.52x3.2mm(1000mm) 300-0502- 016 032 Tygon tubing 2.06x4mm(500mm)
1.2.1 Installation place To ensure that the MYTHIC 22 fulfills its function, place the instrument on a table that supports the weight of the instrument, printer and reagents (around 40 Kg). Leave a space of 10 cm in the rear of the instrument to ensure a well-ventilated place.
Choose a well-ventilated place for the block and be sure to connect this power supply in a socket-outlet with a correct earth connection. The power supply block must be placed at the rear of the MYTHIC 22 and, if possible in an upper position to avoid the contact with any liquid.
Example of neutralization procedure usually used in a laboratory for waste material: For 20 liters of waste, produced by the MYTHIC 22, add 50 ml of a solution of sodium hydroxide (NaOH) at 200g/l, mix the container, add 100ml of bleach at 36°C, mix the container, wait one hour before empty Only use this procedure if there is no specific local legislation for the treatment of the waste.
1.5.2 Priming When first starting the MYTHIC 22, it is necessary to perform a complete prime of the fluidic circuit. Before starting, be sure that all the reagent and waste tubes are properly connected. The reagents must be stored minimum 24 hours at room temperature before use.
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- Press on NOTA To execute an emergency stop push shortly on the switch on/off button - Press : The MYTHIC 22 performs a complete priming cycle. - The cycle LED turns red. No cycle can be performed before it turns green.
1.6 TRANSPORTATION AND STORAGE Storage temperature: -10°C to +50°C. If the MYTHIC 22 has been stored at a temperature less than 10°C it must be left at room temperature for 24 hours. Before transportation outside the laboratory, perform a complete cleaning with a disinfectant in compliance with the local legislation.
ENERAL OVERVIEW 2.1 GENERALITIES The MYTHIC 22 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 ORPHEE controls or calibrators) should be run.
2.3.5 Power Supply Block MYTHIC 22 is supplied with an external power supply block. - In the case of replacement of the main power wire supplied with the MYTHIC 22 the new one must comply with the local regulation. - The MYTHIC 22 has been certified with the power supply box provided with the instrument.
- Enter your identification name with the alphabetic keyboard. - Place the cursor in the password window. - Enter your password for identification. - For the first login, MYTHIC 22 proposes 3 access levels : User : No password, Biologist : Password by default 1- 2- 3 , Service people.
3.4.4.1 Limits: - This display enables to enter normal and panic limits for every 24 parameters given by the MYTHIC 22 (see section 8). - To validate the new values, press VALID key in the next page (see below). - Once modifications are done, press...
3.4.7 Storage options: MYTHIC 22 can save more than the last 1000 patients with results, alarms, distribution curves in the internal memory and until a maximum of 60 000 results in a memory stick (USB key) of 512 Mbit or more.
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Mythic management. The serial number of the Mythic 22 is coded as : xxxxxx-yyyyyy These two groups of 6 digits will be used to create private folders, only usable on one instrument. Root folder for Mythic 22 analyser.
8 to 15 HCT (%) 70 to 80 PLT (10 2000 to 5 000 Repeatability: Calculated with 20 runs of a fresh whole blood sample performed on a commercial MYTHIC 22. PARAMETERS Coefficient Variation RANGE < 2,5% > to 6,0×10 <...
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REF : M22/UM/EN/014 Precision (Reproductibility)* The Mythic 22 was initially calibrated with Myt-CAL calibrator (lot PLUS065, expiry date 14-05-2015). Three levels of Myt-5D control material (lot MYT 506, expiry date 05-08-2015) were run in duplicate twice daily for 20 days. The results were used to quantify within run precision, SD of the run means, SD of the daily means and the total imprecision with the NCCLS EP-05 A2 guidelines.
Relative Humidity: 80% maximum at 32°C. Storage temperature: -10 to 50°C. If the MYTHIC 22 has been stored at a temperature lower than 10°C, it must stay at room temperature for 24 hours before switching it on. If the room temperature change by more than 10°C during the working day, the MYTHIC 22 must be re calibrate.
REF : M22/UM/EN/014 4.3 REAGENTS SPECIFICATIONS All the reagents must be transported and stored at temperature stated on their labels. 4.3.1 Diluent for Mythic 22 ORPHEE code number: HM22-003-10 Open shelf life: 60 days. Application: The diluent is used to carry out the necessary dilutions for the measurement performed by the MYTHIC 22.(see section 8)
OnlyOne Lytic reagent is used as unique leukocyte and hemoglobin reagent to lyse red blood cells, enable cells subpopulations differentiation and counting and quantitatively determine hemoglobin content of blood samples on MYTHIC 22, (see section 8). Active components: alkaline salts,...
3. INSTRUMENT SET UP REF : M22/UM/EN/014 4.3.3 Cleaner for Mythic 22 ORPHEE code number: HM22-001-1 (please do not use HM18-007-1 which is dedicated for Mythic 18) Opening shelf life: 60 days. Application: The cleaning solution is used to carry out the cleaning of the measurement system and hydraulic circuit (see section 8).
3. INSTRUMENT SET UP REF : M22/UM/EN/014 4.3.4 Mythic 18-22 FLUSH – CLEANER ORPHEE code number: HM18-011-025 Application: Mythic 18-22 FLUSH - CLEANER is hypochlorite-based reagent. Its function is periodic and routine cleaning of the measuring system of haematology analysers (see section 9.1.2).
4.4.2 Interferences Occurrence Parameter Specimen action Possible Indication of Error on MYTHIC 22 Cause : high IgM level may lower RBC and increase MCV. Seek for red cell clumping Cold Agglutinin Indication : ↑MCV, ↓HCT, N1 &/or N2 &/or L1 &/or...
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3. INSTRUMENT SET UP REF : M22/UM/EN/014 Occurrence Parameter Specimen action Possible Indication of Error on MYTHIC 22 Indication: NRBC may be detected on the WBC Nucleated RBC Seek for NRBC on smear. scattergram with N1 &/or N2 &/or L1 &/or HL (# &...
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3. INSTRUMENT SET UP REF : M22/UM/EN/014 Occurrence Parameter Specimen action Possible Indication of Error on MYTHIC 22 Cause: Toxic or abnormal granules, as much as degranulated areas may alter optical properties of Seek for granulations Granulations eosinophils and cause an erroneous EOS counting.
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3. INSTRUMENT SET UP REF : M22/UM/EN/014 Occurrence Parameter Specimen action Possible Indication of Error on MYTHIC 22 Centrifuge the sample remove WBC and re-assay Cause: high level of WBC causes excessive light Leukocytosis the re-diluted RBC part. Or scatter that interferes with Hgb measurement.
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3. INSTRUMENT SET UP REF : M22/UM/EN/014 Occurrence Parameter Specimen action Possible Indication of Error on MYTHIC 22 The MCH is determined according to Hgb value and See Hgb value and RBC count. The limitations listed for Hgb and RBC RBC count interferences may cause indirect interferences.
5. S AMPLE ANALYSIS 5.1 VERIFICATIONS BEFORE STARTING Before starting MYTHIC 22, we recommend to check the reagent levels in each bottle and the level of the waste container. Please also check the paper quantity in the printer. 5.2 START UP - Press ON/OFF button on the printer to start.
If the level is higher, MYTHIC 22 displays a window “START UP FAILED”, press OK and perform a new start up. If the user chooses to run samples, every result will be printed with “Start Up not done” message.
The working temperature of the fluidic part must be reached before starting the analysis. The average time to reach it is around 15’ at a room temperature > 23 °C (see 5.6.3). NOTA: The MYTHIC 22 is delivered with a standard parameter setting described in section 3. 5.6.2 Sample Identification...
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-In DIFF mode Press on the matrix to access to a zoomed view. - Press on flags window to access detailed flags window. - In regard of the different flags found by the MYTHIC 22 the upper part proposes list of the cells to check on the smear.
5. SAMPLE ANALYSIS REF : M22/UM/EN/014 5.8 PRINTING Once the analysis is finished, the MYTHIC 22 prints a result report. To modify the printing presentation or to disconnect the printer, see section 3.4.1. To load a new printer driver, see section 3.3.
5.9 LOGS From the main menu, press to reach the logs display. - MYTHIC 22 manage a simplified log allowing saving and displaying all the events done for the following actions: BIO: Login with the Biologist code. TEC: Login with the service Technician code.
5. SAMPLE ANALYSIS REF : M22/UM/EN/014 5.11 STAND BY AND SHUT DOWN NOTA: It is recommended to switch off the MYTHIC 22 if it will be not used for next several hours. - From the main menu, press . MYTHIC 22 automatically performs a shut down cycle.
If result still exceeding the tolerances indicated on the blood control result sheet, it is recommended to perform a calibration (see section 7). 6.2 QC MYTHIC 22 stores in memory up to 100 results per lot, for 6 different lots. Results of each lot can be viewed in tables and Levey-Jennings graph. - Press to have access to the quality control menu.
This screen allows carrying out a test of repeatability on all the parameters measured by the MYTHIC 22. - Dry the needle with a clean paper towel. - Present the control blood under the sampling needle. - Press the start cycle trigger.
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(see section 4.1) repeatability table. This screen allows carrying out a test of repeatability on all the parameters measured by the MYTHIC 22. - Dry the needle with a clean paper towel before each aspiration. - Present the sample under the sampling needle and press in the trigger located behind the needle.
7. C ALIBRATION The calibration of the MYTHIC 22 should be carried out minimum once a year or if the QC carried out on a blood control used under the recommended conditions, is out of the limits to a significant degree (see section 6).
7.1.1 Calibration blood analysis This screen allows carrying out analysis on calibration blood to perform the MYTHIC 22 calibration. -Present the calibration tube under the sampling needle and press the trigger behind the needle. The calibrator should be mixed manually during the all process and between each measurement.
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7. CALIBRATION REF : M22/UM/EN/014 Loading values from targets file (files are available on http://www.orphee-medical.com, distributors area)) and copy it on USB key previously formatted on the Mythic. Put it in folder “LOT”. - Plug the USB key, then - Select the right lot then press - Press if you are sure to load the right file.
REF : M22/UM/EN/014 8. T ECHNOLOGY The innovative technology of the MYTHIC 22 is covered by six pending patents. A new innovative concept of optical measurement system and a unique lysing reagent were developed to obtain a small and powerful analyzer.
8.5 FLAGS MYTHIC 22 manages 25 different flags. These flags allow the user to be alerted if there is a problem which can affect the quality of the results. All of these flags appear on the right of the result.
8. TECHNOLOGY REF : M22/UM/EN/014 8.6 HYDRAULIC DESCRIPTION The hydraulic part of the MYTHIC 22 is very simple and made of these modules: - Sampling module, - Counting bath module, - Syringes module, - Optical manifold, - Optical bench. The modules are connected together by semi rigid tubing.
9. S ERVICE The quality of the results and the reliability of the MYTHIC 22 are directly linked to the strict respect of the maintenance hereafter described. To perform the maintenance and the repair described in this section, it is mandatory to have received adequate training, use the Orphee spare parts accordingly, to wear rubber gloves and wash hands with a disinfectant after completion of work.
- MYTHIC 22 perform a maintenance cycle of the apertures followed with a standby mode during 10 min. - After 10 min. MYTHIC 22 rinses all of the elements. Perform a blank cycle before to run any analytic cycle.
- To test all the valves press 9.4 REPAIRING 9.4.1 Emergency stop In case of mechanical or hydraulic problem, immediately press , the MYTHIC 22 will make an emergency stop. - After having identified the problem, it is necessary to perform a control cycle.
REF : M22/UM/EN/014 9.6 TROUBLESHOOTING MESSAGES This section allows knowing what to do when a troubleshooting message appears on the screen. If the problem persists; go on contact your Orphee representative. MESSAGE ACTION Re-start the Mythic. Update to last SW version if not done.
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THE USB THUMB DRIVE FILE SYSTEM IS NOT The USB thumb drive as an incompatible tree structure for the COMPATIBLE WITH THE MYTHIC 22. EITHER analyzer or no file present in the folder. See section 3.4.7. REMOVE IT OR FORMAT IT.
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