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01/02/2010 > V 1.0 Creation CONTACT ADDRESS MANUFACTURER Manufactured in France for ORPHEE SA 19, chemin du champ des filles CH-1228 Geneva / Plan-les-Ouates SWITZERLAND Tel : +41 (0) 22 884 9090 Fax : +41 (0) 22 884 9099 http://www.orphee-medical.com...
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Do not use the MYTHIC 18 VET 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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RF transmitters, an electromagnetic site survey should considered. If the measured field strength in the location in which the MYTHIC 18 VET is used exceeds the applicable RF compliance level above, the MYTHIC 18 VET 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 18 Vet le dispositif médical de diagnostic in vitro il dispositivo medico-diagnostico in vitro the in vitro diagnostic medical device mit folgender Klassifizierung nach der Richtlinie über In-vitro-Diagnostika 98/79/EG...
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REF : M18 Vet/UM-EN/001 IEC 60601-1-2 (2001) Angewandte Gemeinsame Technische EN 61000-3-2 Spezifikationen, harmonisierte Normen, EN 61000-3-3 nationale Normen oder andere normative EN 61000-4-2 (95) A1 (98) A2 (01) Dokumente EN 61000-4-3 (02) Spécifications techniques communes, EN 61000-4-4 (95) A1(01) normes harmonisées, normes nationales et EN 61000-4-5 A1 (01) autres documents normatifs appliqués...
REF : M18Vet/UM-EN/001 TABLE OF CONTENTS 1. INSTALLATION 1.1 U ......................................10 NPACKING 1.1.1 Introduction ........................................10 1.1.2 Unpacking Procedure ....................................10 1.1.3 Visual checking......................................11 1.2 I ................................11 NSTALLATION CONSTRAINTS 1.2.1 Installation place ......................................11 1.2.2 Installation environment ...................................11 1.3 E ................................12 LECTRICAL CONNECTIONS 1.3.1 Power supply block ......................................12 1.4 P ..................................12...
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REF : M18 Vet/UM-EN/001 5.7 R ......................................49 ESULTS 5.8 P ......................................51 RINTING 5.8.1 Model report (A4) – external printer..............................51 5.8.2 Model report – Ticket printer ................................51 5.9 L ........................................52 5.10 A ......................................52 RCHIVE 5.10.1 Results ........................................53 5.10.2 View..........................................54 5.11 S ................................55 TAND BY AND SHUT DOWN 6.
- The optimum performances can be only achieved if the cleaning and maintenance procedures are carefully followed. If the MYTHIC 18 VET has been stored at a temperature less than 10°C, it must stay at room temperature during 24 hours before switching it on.
1.2.1 Installation place To ensure that the MYTHIC 18 VET 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 18 VET and, if possible in an upper position to avoid the contact with any liquid.
Example of neutralization procedure usually used in a laboratory: For 20 liters of waste produced by the MYTHIC 18 VET, add 50 ml of a solution of sodium hydroxide (NaOH) at 200g/l, mix the container, add 100ml of bleach at 36° Cl, mix the container, wait one hour before empty it.
REF : M18 Vet/UM-EN/001 1.5.2 Priming When first starting the MYTHIC 18 VET, 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. Priming procedure: ...
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2. GENERAL OVERVIEW REF : M18 Vet/UM-EN/001 Main Menu description Print, Direct access to Send, Back to previous Start Up rinsing main menu Select screen and Blank control Options Date and Time. System status (section 3.2). Cleaning and stand by mode Archive of results QC and Calibration menu...
2. GENERAL OVERVIEW REF : M18 Vet/UM-EN/001 2.3.2 Dilution hydraulic part All the fluidic part is on the right side of the instrument and consists of only three modules: Sampling module : Rocker (patent pending): Manages the rise and descent of the needle. Syringe module (patent pending) consists of one block : Reagent syringes (Diluent, lysis), sampling and air syringes.
2.3.4 Power Supply Block MYTHIC 18 VET is supplied with an external power supply block. - In the case of replacement of the main power wire supplied with the MYTHIC 18 VET the new one must comply with the local regulation.
- 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 18 VET propose 3 access levels: User : No password Biologist : Password by default 1- 2- 3 Service people - Biologist Password can be modified in section 3.4.6.
3. INSTRUMENT SET UP REF : M18 Vet/UM-EN/001 - If this window appears, it means that several results in memory have not been sent before the MYTHIC 18 VET was switched off. - Press YES to send them immediately, or press LATER to wait for another time, or NO if you do not want to send them.
3. INSTRUMENT SET UP REF : M18 Vet/UM-EN/001 3.3 SET UP - From the MAIN MENU press on , then SET UP. - This menu is available for all users. - The DATE & TIME window enables to modify the time and the date - To select the language of the Mythic menu, choose the right one in the Language combo box.
3. INSTRUMENT SET UP REF : M18 Vet/UM-EN/001 3.4 ADVANCED SET-UP - This menu is reserved to biologist (see section 3.1). Any modifications can affect the quality of the results. We recommend modifying these values only after an Orphée’s training. - Please refer below for the description of each key.
3. INSTRUMENT SET UP REF : M18 Vet/UM-EN/001 3.4.3 Analysis options: - OPTIONS box: o ALWAYS ID and ALWAYS PID: To run a sample, user mandatory needs to enter a ID and/or a PID. o RUO: With tag the PCT and PDW parameters are displayed, printed and sent.
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3.4.4.1 Limits: - This display enables to enter normal and panic limits for every 18 parameters given by the MYTHIC 18 VET (see section 8). - To validate the new values, press VALID key in the next page (see below).
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3. INSTRUMENT SET UP REF : M18 Vet/UM-EN/001 - This screen allows displaying the WBC thresholds position after a run. - After modification press to allow the recalculation and check the results and flags. - Once modifications are done, press to validate or to exit without any modification.
3. INSTRUMENT SET UP REF : M18 Vet/UM-EN/001 3.4.4.5 Correction factors: - This function can be reached only for any other type than the standard. - In this menu, for each blood type, users can define a correction factor which is multiplied by the calibration factor given by a normal calibration (see section 7).
3. INSTRUMENT SET UP REF : M18 Vet/UM-EN/001 - In DELAY box, the user can modify: o Time in minutes to start the automatic shut down. o Time in minutes to build up the needle. o The setting up of the automatic cleaning and its frequency in number of analysis.
3. INSTRUMENT SET UP REF : M18 Vet/UM-EN/001 3.4.8 Version release: - Press to load a new software version from a USB key. - Choose the right version then, - Press yes only if you are sure to load new version software. The current software version will be erased definitively.
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 18 VET. PARAMETERS RANGE < 2,5% > to 6,010 < 5% >...
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4. SPECIFICATIONS REF : M18 Vet/UM-EN/001 Carry-Over: For each parameter, we perform 3 runs from high concentration sample followed by 3 runs from empty cycles. High concentration value 18,0 5,33 17,9 Measured carry-over (%) 0,18 Maximum carry-over (%) < 1,0 <...
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4. SPECIFICATIONS REF : M18 Vet/UM-EN/001 Intercept Slope Bias Coefficient of Parameter Species (Confidence (Confidence (95% Limits of correlation interval) interval) agreement) 2.05 0.94 0.16 0.99 (1.23 to 2.74) (0.92 to 0.97) (-2.15 to 2.48) 0.95 -0.79 0.99 (0.05 to 2.13) (0.93 to 0.98) (-3.42 to 1.83) 1.36...
Ambient temperature: from 18 to 32°C Relative Humidity: 80% maximum at 32°C Storage temperature: -10 to 50°C If the MYTHIC 18 VET 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.)
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15,00 Consumption with one run sample, add one or two run sample consumption if needed. ** The consumption of the lysis is given for the ORPHEE reagent with a standard adjustment and depends on the animal analyzed. POWER SUPPLY BLOCK: Dimensions: Height:31 mm (approx.)
Shelf life once opened: 60 days. Application: Lytic reagent is used to lyse the red blood cells, the leukocyte differentiation and the cyanmethemoglobin complex formation used during the measurement performed on the MYTHIC 18 VET (see section 8) Active components : 3,50% surfactant.
4. SPECIFICATIONS REF : M18 Vet/UM-EN/001 Storage: At room temperature, until expiry date labeled on the bottle. Precautions: Can cause skin and eyes irritation. Wear a smock, gloves and glasses during manipulation. First emergency care: Inhalation: Breathe fresh air. Eyes: Abundantly rinse during 15 mn. Skin: Abundantly rinse.
4. SPECIFICATIONS REF : M18 Vet/UM-EN/001 4.4 ANALYTICAL LIMITATIONS 4.3.1 Recommendations MAINTENANCE: Please respect the maintenance procedure and the quality control procedure. Otherwise, results can be affected. GENERALITIES: Some abnormal samples may give incorrect results by automated cell counting methods. The following table shows examples of specific specimens that could cause errors.
5. S AMPLE ANALYSIS 5.1 VERIFICATIONS BEFORE STARTING Before starting MYTHIC 18 Vet, we recommend to check the reagent levels 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.
5. SAMPLE ANALYSIS REF : M18 Vet/UM-EN/001 - No USB key is available, connect an USB key then press YES or see section 3.4.7 to change the archive mode. 5.3 REAGENT REPLACEMENT - To check the level of reagents, press then REAGENTS - If the pack needs to be replaced, proceed as indicated in section 1.5.2...
PLT : 10 If the level is higher, MYTHIC 18 VET proposes to perform a new start up or to escape. If the user chooses to escape, every result will be printed with “Start Up not done “message. 5.5 PREPARATIONS BEFORE ANALYSIS The Veterinary blood venous sample must be collected in an EDTA K3 (Ethylene Diamine Tetracetic Acid, tri potassic) tube in sufficient quantity.
5. SAMPLE ANALYSIS REF : M18 Vet/UM-EN/001 5.6.2 Sample Identification - From the main menu, press one icon between the set of icons available: : Dog : Cat : Horse : Others animals to reach the analysis display. - This prompt appears when the results memory is almost full. To avoid this message, select the option FIFO mode in the set up.
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5. SAMPLE ANALYSIS REF : M18 Vet/UM-EN/001 - To enter or modify identification, place the cursor in the selected field with your finger or the arrow. - To enter a figure, use the keyboard on the right of the screen, for a letter use the alphabetic keyboard by pressing - To accede to another character page press - To change the blood type, press the combo box...
Start cycle trigger - As soon as the cycle is launched, the SID is incremented automatically and, thanks to its data processing multitasks, the MYTHIC 18 VET is available for the identification of the following sample (see section 5.6.2). 5.7 RESULTS - The results of the analysis are sent before the cycle is finished (to be checked) at the same time as the printer starts.
- To close the window, press 5.8 PRINTING Once the analysis is finished, the MYTHIC 18 VET prints a result report. To modify the printing presentation or to disconnect the printer, see section 3.4.1. 5.8.1 Model report (A4) – external 5.8.2 Model report –...
5.9 LOGS From the main menu, press and LOGS to reach the logs display - MYTHIC 18 VET manages a simplified log allowing to save and display all the events done for the following actions: BIO: Login with the Biologist code.
5. SAMPLE ANALYSIS REF : M18 Vet/UM-EN/001 5.10.1 Results - The Archive display allows viewing the results of the analysis. - The first column presents the name of the different parameters, the first line the result number. - The results of the patients are presented in column. - At the bottom of the display, under the table, the ID, PID, SID, SEQ number, date and time of the selected patient (dark background) are presented for each result selected.
5. SAMPLE ANALYSIS REF : M18 Vet/UM-EN/001 - To print, send, delete or save results per day press - It is possible to print, send, delete or save: . All results of the same month: Press . Between two days of the same month: press - The printed report is a list of all selected results between the two days.
In case of exceeding the tolerances indicated on the blood control result sheet, it is recommended to perform a calibration (see section 7). 6.2 QC MYTHIC 18 VET 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 then QUALITY CONTROL to have access to the quality control menu.
6. QUALITY CONTROL REF : M18 Vet/UM-EN/001 - Tag the lot number to select then press the appropriate button. allows to save the targets, results and graphics in the USB key. 6.2.1 Change - In this display, the user can enter the: Lot number Expiry date Target values and tolerances...
6. QUALITY CONTROL REF : M18 Vet/UM-EN/001 6.2.2 Run control blood - Press to run the control blood. Before to run the control, check and clean the opening of the cover enabling the descent of the needle, to avoid any fall of dry blood particles inside the control tube - To run quality control analysis: Press Results.
6. QUALITY CONTROL REF : M18 Vet/UM-EN/001 6.2.3 Levey-Jennings graph - This menu enables to display the Levey-Jennings graph for each quality control run. - The column on the left shows each parameter with the target values and the limits. The value under the name of the parameter is the value where the cursor is located on the graph.
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This screen allows carrying out a test of repeatability on all the parameters measured by the MYTHIC 18 VET. - Present the sample under the sampling needle and press in the trigger located behind the needle.
7. C ALIBRATION The calibration of the MYTHIC 18 VET 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).
7.1 RESULTS 7.1.1 Calibration blood analysis This screen allows carrying out analysis on calibration blood to perform the MYTHIC 18 VET calibration. BEFORE TO CALIBRATE THE MYTHIC 18 VET, PLEASE CONTACT YOUR REPRESENTATIVE. - Present the calibration tube under the sampling needle and press the trigger behind the needle.
7. CALIBRATION REF : M18 Vet/UM-EN/001 7.1.2 Calibration Before to start the calibration, unselect the results which you do not wish to use for the calculation of the calibration (see below section 7.1.1). - The key allows: To calibrate with the selected results. ...
8. TECHNOLOGY REF : M18 Vet/UM-EN/001 8. T ECHNOLOGY 8.1 DETECTION PRINCIPLE 8.1.1 WBC, RBC, PLT Counting The counting of the cellular elements in a blood sample is done with the impedancemetry technique. This technique is based on the modification of the impedance of a calibrated aperture soaking in an electrolyte and going through a constant course delivered by two electrodes located on both sides of the aperture.
8. TECHNOLOGY REF : M18 Vet/UM-EN/001 8.1.2 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 cyanmethemoglobin type, for lytic solution with cyanide and oxyhemoglobin for lytic solution without cyanide. A measurement of the blank of hemoglobin is done for each analytic cycle and during the start up rinsing step.
8. TECHNOLOGY REF : M18 Vet/UM-EN/001 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) Red Blood Cells Erythrocytosis : RBC>RBC h Hemoglobin...
8.5 ALARMS MYTHIC 18 VET manage 17 different alarms. These alarms allow the user to be alerted if there is a mistake which can affect the quality of the results. All of these alarms appear on the right of the result.
8. TECHNOLOGY REF : M18 Vet/UM-EN/001 8.5.2 Leukocytes Flags CL1-2 CL2-2 CL2-3 L1 = CL1 to CL1-2: Platelet aggregate or erythroblast L2 = CL2 to CL2-2: Presence of Myelocytes, lymphoblast or basophiles. L3 = CL2 to CL2-3: Presence of eosinophils, myelocytes. L4 = CL4 Granulocyte volume too low L5 = CL5 to the end: Presence of large size cells.
8. TECHNOLOGY REF : M18 Vet/UM-EN/001 8.6 HYDRAULIC DESCRIPTION The hydraulic part of the MYTHIC 18 VET is very simple and made of only three modules: - Sampling module. - Counting bath module. - Syringes module. The modules are connected together by semi rigid tubing.
8. TECHNOLOGY REF : M18 Vet/UM-EN/001 8.7 SOFTWARE 8.8.1 Windows Common keys: This three keys are always present in all screen allows to come back to the previous display. allows to come back to the MENU display where ever 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 or delete it.
9. S ERVICE The quality of the results and the reliability of the MYTHIC 18 VET 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.
- MYTHIC 18 VET perform a maintenance cycle of the apertures follow with a standby mode during 2 min. - After 2 min. MYTHIC 18 VET rinses all of the elements. Perform a blank cycle before to run any analytic cycle 9.1.3 Piston greasing...
9. SERVICE REF : M18 Vet/UM-EN/001 Wear rubber gloves and wash hands with a disinfectant after completion of work. - Wait for the information window and then - Open the door on the right side (see section 1.1.3). - Put a small nut of grease on a finger. - Put a thin film of grease around each piston.
9. SERVICE REF : M18 Vet/UM-EN/001 drain counting baths waste syringes, press fill counting baths with diluent, press - To perform a cleaning of the aperture block with the cleaner, press perform back flush aperture blocks, press 9.3 MECHANICS - To have access to this cycle, press from the MAIN MENU, then press CHECK VALVES: See below.
9.4.1 Emergency stop In case of mechanical or hydraulic problem, immediately press , the MYTHIC 18 VET 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...
9. SERVICE REF : M18 Vet/UM-EN/001 9.4.2 Needle or o-ring replacement Wear rubber gloves and wash hands with a disinfectant after completion of work. - From the main menu, press then to go to the display described on the left. - Press on - The rocker places the sampling needle in the disassembling position.
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9. SERVICE REF : M18 Vet/UM-EN/001 - Draw the system towards outside - Remove the tubing fixed at the end of the needle. - Unscrew the serrated roller which maintains the seal and the needle. - Leave the serrated roller, the needle and the o-ring from the rinsing head.
9. SERVICE REF : M18 Vet/UM-EN/001 - Remove the o-ring. - Replace the needle with or the o-ring. REASSEMBLY PROCEDURE: To reassemble the unit, carry out the various operations in the opposite direction. Place the seal on the needle gently not to wound it. 9.4.3 Baths dismantling This procedure must be carried out to replace the bath seals on the manifold or the aperture seals.
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9. SERVICE REF : M18 Vet/UM-EN/001 - To remove the counting bath module, very carefully and slowly, draw on the clip while pushing the top from the counting bath towards the inside of the machine - Then, upwards, raise the counting module. - Next, remove the tubing fixed on the RBC counting head, located on the right side of the counting module.
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9. SERVICE REF : M18 Vet/UM-EN/001 - Remove the tubing fixed on the plastic fitting located under the stainless tube from WBC counting block. - Remove all connectors. - The counting bath module can now be handled to carry out the desired operations of replacement.
9. SERVICE REF : M18 Vet/UM-EN/001 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.
9. SERVICE REF : M18 Vet/UM-EN/001 - Remove the o-ring and replace 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. REASSEMBLY PROCEDURE: To reassemble the unit, carry out the various operations in the opposite direction.
Check the power supply connection wires. All results bad Check the level diluent and if the supply tubing is pinched. Check if the diluent is placed at the same level as the MYTHIC 18 VET No display Check the flat cable. and/or typing ID and/or PID are mandatory (see section 3.4.3).
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9. SERVICE REF : M18 Vet/UM-EN/001 ACTION MESSAGE Change the valve CYCLE: CMD VALVE FAILED Perform a control cycle. CYCLE: EMERGENCY STOP Close the door, in case of emergency stop run a control cycle CYCLE: FLUIDIC DOOR OPENED CYCLE: HGB CHANNEL SATURATION. PLEASE RUN Run Startup Cycle.
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9. SERVICE REF : M18 Vet/UM-EN/001 ACTION MESSAGE Re-start the Mythic. RS232: TIME OUT Press OK. RUNNING AUTO CLEANING You have to be Logged with the good access code SETUP: MODIFICATION NOT ALLOWED. Perform a start up cycle. START UP CYCLE NOT DONE Perform a new start up cycle STARTUP CYCLE FAILED Update the SVM software...
9. SERVICE REF : M18 Vet/UM-EN/001 9.7 LOGS ERRORS - From the MAIN MENU press , then SERVICE - Then press LOG ERRORS - This screen allows visualizing the date and timing when an error has occurred, as well as the code and the origin of this error. - To see the origin of the error, press on the figure located on the left of the date, the complete error appears at the bottom.
9. SERVICE REF : M18 Vet/UM-EN/001 9.8 HYDRAULIC DIAGRAM The length and inner diameters of the tubing shown on the diagram below the tubing table must be strictly respected when replaced; otherwise there is a significant risk in the quality of results given.
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