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22 User’s Manual Orphée SA 19, chemin du Champ des Filles - 1228 CH-Plan Les Ouates / SWITZERLAND Tel : +41.(0)22.706.18.40 Fax : +41.(0)22.794.43.91 - Web Site : www.orphee-medical.com...
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 emmissions The MYTHIC 22 is intended for use in the electromagnetic environment specified below. The customer or the user of the MYTHIC 22 should assure that it is used in such an environment.
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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.
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Nous déclarons sous notre propre responsabilité que Dichiariamo sotto nostra responsabilità che We declare under our sole responsibility that das Medizinprodukt für die In-vitro-Diagnostik Mythic 22 le dispositif médical de diagnostic in vitro il dispositivo medico-diagnostico in vitro Ref. M22OT the in vitro diagnostic medical device mit folgender Klassifizierung nach der Richtlinie über In-vitro-Diagnostika 98/79/EG...
- The optimum performances can be only achieved if the cleaning and maintenance procedures are carefully followed. If the MYTHIC 22 has been stored at a temperature less than 10°C it must be left at room temperature during 24 hours.
1.2.1 Installation place To ensure that the MYTHIC 22 fulfills its function, place the instrument on a table which supports the weight of the instrument, printer and reagents (around 40 Kg). Leave a space of 10 cm in the rear of the instrument to ensure a well-ventilated place.
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.
1. INSTALLATION REF : M22/UM/EN/006 1.5 CONNECTION, CHANGE AND PRIMING REAGENTS MYTHIC 22 works with the reagents described in section 4.3. Some commercial reagents can also be used. Please contact your Orphée’s representative. 1.5.1 Connection Lysis reagent and cleaning solution: Before handling the reagents, read carefully their specifications described in section 4.3.
REF : M22/UM/EN/006 1.5.2 Priming When first starting the MYTHIC 22, it is necessary to perform a complete prime of the fluidic circuit. 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.
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- Press on NOTA To do an emergency stop push shortly on the switch on/off button - Press : The MYTHIC 22 performs a complete priming cycle. - The cycle LED 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 during 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 MYTHIC 22 is a fully automated analyzer performing hematological analysis on whole blood collected on EDTA K2 or K3 tubes. Sample volume: 15,7 µl (inside the needle, the total volume could be upper in function of the blood remaining outside of the needle).
Switch on/off MYTHIC 22 is supplied with an external power supply block. - In the case of replacement of the main power wire supplied with the MYTHIC 22 the new one must comply with the local regulation. - The MYTHIC 22 has been certified with the power supply box provided with the machine.
- 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 - Biologist Password can be modified in section 3.3.6.
3. INSTRUMENT SET UP REF : M22/UM/EN/006 - If this window appears, it means that several results in memory have not been sent before the MYTHIC 22 was switched off. - Press YES to send them immediately, or press LATER to wait at another time or NO if you do not want to send them.
- Then press - Press then, the driver is loaded in the MYTHIC 22 - This prompt appears if the release is failed. Check the USB connection or change the USB key or call your Orphée’s representative. This prompt appears if the release is done successfully.
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3.4.4.1 Limits: - This display enables to enter normal and panic limits for every 22 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.
8 to 15 HCT (%) 70 to 80 PLT (10 2000 to 4 000 Repeatability: Calculated with 20 runs of a fresh whole blood sample performed on a commercial MYTHIC 22. PARAMETERS RANGE < 2,5% > to 6,0 10 < 5% >...
Ambient temperature: from 18 to 34°C Relative Humidity: 80% maximum at 32°C Storage temperature: -10 to 50°C If the MYTHIC 22 has been stored at a temperature less than 10°C, it must stay at room temperature during 24 hours before switching it on. INSTRUMENT: Dimensions: Height: 350 mm (approx.)
4.3.1 Diluent ORPHEE code number: HM22-003-10 Opening shelf life: 60 days. Application: The diluent is used to carry out the necessary dilutions for the measurement performed by the MYTHIC 22.(see section 8) Active components: Solid content: 0,9%. Others components: Buffer.
OnlyOne Lytic reagent is used as unique leukocyte and hemoglobin reagent to lyse red blood cells, enable cells subpopulations differentiation and counting and quantitatively determine hemoglobin content of blood samples on MYTHIC 22, (see section 8) Active components: - alkaline salts and buffering means...
4. SPECIFICATIONS REF : M22/UM/EN/006 4.3.3 Cleaning solution ORPHEE code number: HM22-001-1 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). Components: Enzyme...
4.4.2 Interferences Occurrence Parameter Specimen action Possible Indication of Error on MYTHIC 22 Cause : high IgM level may lower RBC and increase Seek for red cell clumping Cold Agglutinin Indication MCV, HCT, N1 &/or N2 &/or L1 &/or...
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4. SPECIFICATIONS REF : M22/UM/EN/006 Occurrence Parameter Specimen action Possible Indication of Error on MYTHIC 22 Indication: Nucleated RBC NRBC may be detected on the WBC Seek for NRBC on smear. (# & %) Erythroblastosis scattergram with N1 &/or N2 &/or L1 &/or HL flags...
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4. SPECIFICATIONS REF : M22/UM/EN/006 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 modifications on smear (# &...
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4. SPECIFICATIONS REF : M22/UM/EN/006 Occurrence Parameter Specimen action Possible Indication of Error on MYTHIC 22 Centrifuge the sample Cause: high level of WBC causes excessive light remove WBC and re-assay Leukocytosis scatter that interferes with Hgb measurement. the re-diluted RBC part. Or Indication: very high WBC (>100,000/ L), MCHC...
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REF : M22/UM/EN/006 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 RBC count. The limitations listed for Hgb and RBC 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.
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- Press on the matrix to access to a zoomed view. - Press on the flags zone to open the flags window. - In regard of the different flags found by the MYTHIC 22 the upper part propose list of the cells to check on the smear.
5. SAMPLE ANALYSIS REF : M22/UM/EN/006 5.8 PRINTING Once the analysis is finished, the MYTHIC 22 prints a result report. To modify the printing presentation or to disconnect the printer, see section 3.4.1. To load a new printer driver, see section 3.3.
5.9 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/006 5.11 STAND BY AND SHUT DOWN NOTA: It is recommended to switch off the MYTHIC 22 if it is not use for several hours consecutives. - 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.
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This screen allows carrying out a test of repeatability on all the parameters measured by the MYTHIC 22. - 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 only if the QC carried out on a blood control used under the recommended conditions, is out of the limits to a significant degree (see section 6).
Model of print out calibration report: 7.1 RESULTS 7.1.1 Calibration blood analysis This screen allows carrying out analysis on calibration blood to perform the MYTHIC 22 calibration. - Present the calibration tube under the sampling needle and press the trigger behind the needle.
REF : M22/UM/EN/006 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 an unique lysing reagent were developed to obtain a so small and powerful analyzer.
8.5 FLAGS MYTHIC 22 CT manages 25 different flags. These flags allow the user to be alerted if there is a problem which can affect the quality of the results. All of these flags appear on the right of the result.
8. TECHNOLOGY REF : M22/UM/EN/006 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, to wear rubber gloves and wash hands with a disinfectant after completion of work.
9.1.2 Concentrate cleaning This cleaning is necessary once a week to clean the WBC and RBC baths or when MYTHIC 22 is in permanent rejection for one measured parameter or if it give too much clog flags (see section 8.5.1).
- MYTHIC 22 performs a maintenance cycle of the apertures and the flow cell follow with a standby mode during 2 min. - After 2 min. MYTHIC 22 rinses all of the elements. Operator can perform an analytic cycle. Wear rubber gloves and wash hands with a disinfectant after completion of work.
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. - To have access to this cycle, press...
Bad printing Check the black ribbon. 9.6 TROUBLESHOOTING MESSAGE This section allows knowing what to do when a troubleshooting message appears on the screen. If the problem go on contact your Orphee representative. ACTION MESSAGE Re-start the Mythic. BACKUP : FOLDER NOT FOUND...
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