Mythic 22 Workbook-V3 PDF [PDF]

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Mythic™22 Service Engineer Training Workbook

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Orphée S.A/M22/SEW/003

Proprietary Statement Copyright 2006, Orphée S.A. All rights reserved. No part of this document may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopied, recorded, or otherwise, without the prior written permission of Orphée S.A. Service engineer training workbook usage disclaimer Information contained in this document was developed for use by trained Orphée S.A. service engineers personnel, or by other persons knowledgeable or experienced with operation and service of the Mythic system. Trademark statements Mythic is a trademark of Orphée S.A.

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Revision history

Pages revised and added

SEW/001

12/2006

First release

SEW/002

01/2008

Second release: USB function version 2 and Higher Cap Piercing version

SEW/003

09/2009

Third release: Add electronic troubleshooting Add Technical Notes in Section 8

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Mythic™22 Service Engineer Training Workbook Index

Section Section Section Section Section Section Section Section Section

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1……………………………Overview 2…………………………..User Interface 3…………………………..Mythic™22 Fluidic 4…………………………..Mythic™22 Electronic 5…………………………..Mythic™22 Mechanic 6…………………………..Mythic™22 Optic 7…………………………..Mythic™22 Heater 8…………………………..Technical Notes 9…………………………..Mythic™22 CT – Cap piercing module

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Section 1: Overview      

Learning Objectives Front view Right side view Rear view Left side view Physical specifications

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Learning objectives Section 1 will provide and overview of the system and physical dimensions of the Mythic™22. After reviewing Section 1 of this workbook you should be able to do the following:   

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Identify the connections located on the rear of the Mythic™22. Connect the right reagents on the right connectors. Identify the different fluidic module of the Mythic™22.

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Mythic™22 – front view

Power Switch TFT Display touchscreen

Numerical Keyboard

Status Indicator LED

Start Cycle key

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Mythic™22 – Right Side View

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Mythic™22 – Rear View

USB ports TCP/IP port Barcode reader Waste connector

RS232 port

Diluent connector

Centronic port 24 V Power supply connector

External grounding

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Mythic™22 – Left side view

Lyse solution Straw

Cleaner Straw

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Mythic™22 – Physical Specifications Physical dimensions Dimension Height Width Depth Weight

Instrument 350 mm 250 mm 340 mm 12 kg

Note: For complete listing of physical specifications, refer to Mythic™22 System Operator’s Manual.

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Section 2: User Interface   

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Learning Objectives. Operator Screens. Technician Screen.

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Learning Objectives Section 2 will explain the user and service interface. After reviewing this section of the workbook you should be able to do the following:      

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List the main menus of the instrument. Describe how to calibrate the instruments. Describe how to restore Quality Control values. Describe how to connect the SVM. Describe how to check the pressure on the Mythic™22. Describe where to adjust the electronic gains.

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Operator Screens – Main tree

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Operator Screens – Login

1- Password:    

None 123 2TEC MAPD

: : : :

User – Lab tech Chief of lab Field Service Engineer Super Technician

Note1: with MAPD password, everything is possible, no alert message is displayed. Note2: We recommend using the 2TEC password during the installation of a new instrument. 2- Language: Choose the selected language with the scroll bar.

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How to use the USB key The USB key must be formatted before any use. The format should be done on the Mythic 18. How to proceed? 1. Plug the USB key on o o

One of the two USB port for the Mythic 18 equipped with normal USB port. The USB port on the lower position for the Mythic 18 equipped with small USB port (like camera USB port).

2. Go to Set Up, Advanced menu, Storage Options.

3. Then, press USB thumb drive format. 4. When the format is finished a prompt will appear. o

If the USB key is not compatible, a prompt will appear to inform you. In this way, try another one.

NOTE: The format is done in FAT16. For this reason it is not necessary to equip the Mythic 18 with a USB key with a capacity higher than 2 Gb. 2 Gb capacity = Around 60.000 patients. 128 Mb capacity = Around 10.000 patients.

Once your USB key is formatted, you can start to work with it.

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Overview of the main tree of the USB key: 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

Common folders. The content of this part can be used on all Mythic 22 instruments. NOTE: These folders must be created manually, with Explorer Windows for example.

All of these folders and datas contained in these folders are dedicated to the instrument and can’t be transfer to another instrument. Each folder is automatically created by the Mythic 22.

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Folders description: 1/ Common datas

files

LOT

MXC1234.QCN MBC02174.QDL (target name.Test_Level) CAL0233.CAL (target name.CAL) USER.SET

Qc target values

V100-004.b ( version name.b) HP6122.LPT (prn_name.port LPT or USB )

SETTINGS UPDATE\ VERSION UPDATE\ PRTDRV

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COMMONS DATAS : \ROOT\ contents comments

(sub)Folder

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Format and Analyser unit Write/Read

One file per target Limited at 100 files

ASCII STD unit

Common settings

One file

ASCII + UTF-8

Software release

One file per software release

binary

NO/YES

Printer drivers

One file per printer driver

binary

NO/YES

Calibration target values

NO / YES YES / YES

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2/ Mythic 18 dedicated data

(sub)Folder CALI

Format and unit

Analyser Write / Read

221006.CAL (calibration date as DDMMYY.CAL) LOG_ERR.CSV LOG.CSV CRXV6875.QCN (target name.level)

Calibration report = calibration factors + target + results Error log service log QC report = target + results

One file per calibration date

ASCII + UTF-8 current unit

YES / NO

Two files

ASCII

YES / NO

One file per QC target and level

ASCII + UTF-8 STD unit

YES / YES

RESULTS\ YYYY-MM\ DD

0047.CSV (sequence number. CSV)

Result analysis

ASCII + UTF-8 current unit

SETTINGS

TECH.SET

Private analyzer settings

One sub folder per Year/month (YYYYMM), One sub folder per day (DD), One file per result Limited to 510 files One file

REAGENTS

REAGLOGS.CSV

Private reagents log

One file

ASCII

LOG QC

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PRIVATES DATAS : \ROOT\xxxxxx\yyyyyy\ Files name (example) contents comments

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ASCII + UTF-8

YES / YES

YES / YES YES / YES

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Once installed, you can use the USB key how you want. Two cases: 5. The USB key is not connected on the instrument: All the patient results will be saved on the internal memory of the instrument.

NOTE: The capacity of the internal memory is 1.500 patient results instead of 500 in the previous version.

When the key will be locked on the instrument, the Mythic 18 will ask you if you want to transfer the data on the USB. In this way, these data will be erased from the internal memory. 6. The USB key is connected on the instrument: If you have activated the option Real time runs save in the Storage Options, all the results from the patient will be directly saved on the USB key.

NOTE: To avoid the problem of memory full, we recommend activating the option FIFO Mode (First In, First Out) in the storage options. When the memory is almost full the first result will be erased and replaced by the last one.

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New printer options: With the upgrade 2.0.0-009 or higher, we provide you with two USB drivers: - 1st driver is a PCL3 driver, common to many USB printers. - 2nd driver is a PCL6 driver, used by Laser Color printer like HP Color Laserjet 2605. How to install this driver:      

Plug your USB key on a computer. Create the folder UPDATE in the root folder M18, and the sub-folder PRTDRV, respecting the size of the letters. Upload the driver in the PRTDRV folder. Plug your USB key on the Mythic 18. Go to Set-Up. Select PRINTER 3 UPDATE. 

 



o o

From the page displayed, select the driver you need to install and press LOAD. Validate the message of confirmation. After uploading, go to PRINTER and select the printer you installed. To finish, select the format of the paper. o 12” = A4 format o 11” = US Format

6” = A4 format, 2 results per page 5,5” = US Format, 2 results per page.

In the Advanced Set-up you can select 3 new options in the Printer menu:  



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Automatic Print-out Analysis: o Check box activated: ON o Check box inactivated: ON DEMAND Automatic Print-out Start Up: o Check box activated: the result of the background is automatically printed. o Check box inactivated: No print. Automatic Print-out QC: o Check box activated: QC run is automatically printed. - 24 -

o

Check box inactivated: QC run not printed.

Archive of patients: In the previous version, all the patients were archived in the same table from 1 to 500 (max.). With this new version, each patient result is archived in list of the day with the following architecture: o o o o o o -

YY/MM1 dd1 dd2 etc … YY/MM2 dd1 dd2 etc … etc … Step 1: To display one result for one patient, you just need to load the list of the day while pressing the DATE button in the ARCHIVE menu.

Step 2: Select either “INTERNAL MEMORY” or “MASS STORAGE” INTERNAL MEMORY = Mythic 18 memory MASS STORAGE = USB Drive.

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Step 3: The screen is shared in two parts: - On the left, the list of the year and months in the memory, - On the right part, the list of days for the selected month. By default, the current month is displayed. Select the day while pressing on it then, press in VIEW. The list of results for this day is displayed.

From the archive menu, it is possible to save some results from the internal memory to the USB drive. To proceed, press on TOOLS from the main screen of the archive menu, select the days you want to save, press SAVE.

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New communication protocol With the update version 2.0.0-009 or higher, it is now possible to connect the Mythic 22 either with RS232 cable or using TCP/IP protocol. This new option is available in Set-up, Advanced, and Communications. -

Host serial = RS232 connection Host net = TCP/IP protocol SVM serial = to connect to SVM through RS232 connection.

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Once you select one option, you can define the setting for each option. o SERIAL PARAM. For RS232 connection o NET. PARAM. for Network connection

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For the SERIAL PARAM., normally you don’t need to modify the default setting.

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For the NET. Parameters, select UDP/IP or TCP/IP protocol, then input the different requested information about the host and the instrument (Automaton).

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The MAC address is defined on the CPU board. If no MAC address is displayed, please contact us.

Due to the new functionalities on the Mythic 22, please refer to the document “CP.pdf” to modify the communication protocol for the existing connection.

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Operator Screens – Main Menu

Toolbar available in each menu: Menu: Go back to Main Menu Previous screen: Come back to the previous menu. Tools: Print, Send, Save, Delete. Date/time: By pressing, gives the following informations.

Mythic S/N Password SW version

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Operator Screens – Reagents

Note: Either you change one reagent and you prime this reagent or you change all the reagents and you prime all.

Input The lot diluent Expiry date Volume of container in ml. Press Change Reagent to confirm.

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Operator Screens – Calibration

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1.

2. Input lot, targets, limits or press Load to load these data from USB key

3. Press load on the previous menu and select a lot.

4. Press Result and run calibrator at least in triplicate. Press Calibration to calibrate.

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Operator Screens – Quality controls

1. Choose one lot

3. Press Load on the previous menu, and then, select the file you need to load, finish by Load.

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2. Input lot, targets and limits, or press load to load a lot from USB key

4. Run your control selecting Result

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Operator Screens – Set Up

Only available with biologist password

Communication default parameters : Format : Shell Bauds : 115200 Parity : None Stop Bit : 1 Flow : No Length : 8 Refer to Service Manual for the output format to connect Mythic™22 to LIS.

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Operator Screens – Set Up

Default parameters : Shut down : 180 mn. Needle Up : 5 mn. Valid Autoclean : Activated Clean frequency : 80 Valid. Wake Up unchecked Pressure checking Check Note: if the customer performs more than 100 tests per day, let the autoclean activated. The shut down inactivates the test counting for autoclean. Activate the reagent checking to check the validation of the expiry date as well as the remaining volume of the reagents. To avoid waiting 30 minutes during the warm up on the morning, we recommend checking the option Valid. Wake Up and input the time. The pressure checking option can’t be modified by the customer, only by the service engineer

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Operator screens – SVM Connection

Set Up of the SVM in the Mythic™22 menu: Set Up. Advanced. Communication. Check the radio button SVM Serial.

Connect the RS232 cable between Mythic™22 and Computer. The cable configuration should be as described below.

Mythic 18 DB9 male 1 2 3 4 5 6 7 8 9

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PC DB9 Female

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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1 CD 2 RXD 3 TXD 4 DTR 5 GND 6 DSR 7 RTS 8 CTS 9 RI

Technician Menu

This entire menu is available for all the users. Control Cycle: To use after an emergency stop. Motor Init: To reinitialize the 3 steppers motors. Hydraulics: To clean the system in case of clogging. Mechanics: To check the entire mechanical part of the instrument. Repeatability: To test the repeatability of the instrument. (up to 20 replicates) Log Errors: All the errors from the instruments. Technician: Only available with technician password.(See next section)

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Technician Menu – Mechanics Pressure: In the stand by mode, the pressure is 0. To check a leak of pressure: Run a cycle (Run Analysis) Stop the cycle by pressing the ON/OFF button, when pistons are in medium position. Go to Check Sensors. Check the value for Pressure. This value must be unchanged along the time. If the pressure decreases, check the tubing and the syringe block. HGB sensor: If the LED is OFF, the value must be around 0. If the LED is ON (turn ON in the previous menu), the value must be between 850 and 950. WBC and RBC sensors: In Stand by mode, the values are less than 30. These values are measured directly on the preamplifier board. If one or both values are higher (higher than 100), check for interferences inside the machine or check for an interference source outside the machine. Temperature: 3 sensors allow checking the temperature inside and outside the instrument. Temperature (Near Pressure): gives the room temperature. Enclosure Temperature: gives the temperature inside the machine. Reagent temperature: gives the temperature in the reagent heater

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Technician Menu – Technician part

Note: This part is only available with the technician password: 2TEC Only available with super technician password.

CO=Aperture Current. To check the current inside the counting bath. Turn 0N by pressing the button. Open the fluidic door. Put a pin of the voltmeter inside the courting bath, a pin to the ground. Measure the voltage. For WBC chamber, the value should be around 9V. For RBC/PLT chamber, the value should be around 13V. If the values are different, either change the counting chamber or the CPU board.

NOTE: The different sub-menus will be developed in the different sections, hereafter.

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Technician Menu – Technician part

To adjust the electronic gains for WBC, RBC and PLT. To adjust the HGB blank. See section Electronic part.

To clean the entire instrument before packing. Note: Never travel with liquid inside the instrument. To unlock the instrument To adjust all the parameters of the optical bench

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Section 3: Mythic™22 fluidic   



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Learning Objectives. Fluidic diagram. The different modules. o Sampling module o Counting module o Syringe module Troubleshooting on the fluidic part.

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Learning Objectives Section 3 will explain the Mythic™22 fluidic. After reviewing this section of the workbook you should be able to do the following:     

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List the main modules of the instrument. Describe how to replace a sample probe. Describe how to change the O-rings. Describe how to fix a clogging problem. Describe how to diagnosis and fix a pressure leak.

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General fluidic diagram

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Fluidic cycles description: Sampling cycle 1- Syringes down: (no valve) ~16.7 µl of blood sample are draw inside the sampling needle Diluent prime Vacuum prime 2- Needle up and syringe up (valve 3+4 ON) Needle outside cleaning with diluent (~0.7 ml) and waste vacuum 3- Rocker move above the WBC bath and the syringes up to drain the waste (valve 7 ON) 4- Needle down to the rinsing position 5- Syringe down WBC bath drain (valve 1 ON) Tubing transfer drain (valve 11+14 ON) 6- Syringe up Second outside needle cleaning (~1.5 ml) (valve 4 ON) Waste syringe drain (valve 7 ON) 7- Syringe down WBC bath drain (valve 1 ON) 8- Syringe up Waste syringe drain (valve 7 ON)

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Fluidic cycles description: Sample dilution WBC Dilution 9- Needle down to the dilution position and the syringes down to prime the diluent (valve 8 ON) 10- Syringe up for the WBC dilution (~2 ml) Diluent outside of the needle (valve 4 ON) Diluent inside the needle (valve 4+5 ON) Bubble to mix the dilution (valve 1 ON) RBC dilution and lysing 11- Syringe down (no valve) Drawing sample of the first dilution (~25µl) Diluent prime Vacuum prime 12- Needle up and syringe up Rocker move above the RBC bath Needle outside cleaning with diluent (~0.5 ml) and waste vacuum (valve 3+4 ON) 13-

Needle down to the rinsing position

14- Syringe up Second outside needle cleaning (~0.9 ml) (valve 4+8 ON) Lysis in the WBC bath (0,73 ml) (valve 9 ON) Bubble to mix the dilution (valve 1 ON) 15- Syringe down RBC bath drain (valve 2 ON) 16-

Needle down to the dilution position

17- Syringe up for the RBC dilution (~2 ml) Waste syringe drain (valve 7 ON) Diluent outside of the needle (valve 4 ON) Diluent inside the needle (valve 5 ON) Bubble to mix the dilution and diluent to rinse the counting head (valve 6+10+2 ON) 03/09/2009

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Fluidic cycles description: Measurement: 18- Syringe down to process the vacuum counting (valve 8 +10 ON) 19- First measurement sequences, CBC 2 seconds (valve 10 ON) 20-

Syringe up Diluent back pressure (valve 4+6 ON)

21- Syringe down to perform the vacuum counting (valve 8 +10 ON) 22-

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Second measurement sequences (valve 10 ON) CBC Measurements, 8 seconds (valve 10 ON ) Syringe up for DIF measurements, 12 seconds (valve 4+9+12+13+16+17)

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Fluidic cycles description: Cleaning and drain Drain and Rinse bath 23-

Cleaning Cleaning the apertures (valve 11 ON) Back pressure in the injector (valve 4+13+14 ON)

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Syringe down WBC bath drain (valve 1 ON) Tubing transfer drain (valve 11+14 ON) RBC bath drain (valve 2 ON)

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Syringe up RBC bath rinse diluent (~2 ml) (valve 4 ON) Waste syringe drain (valve 7 ON)

26- Needle up and syringes up for back flush (valve 4+6 ON) 27-

Rocker move above the WBC bath

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Syringe up WBC bath rinse diluent (~2.5 ml) (valve 4 ON) Waste syringe drain (valve 7 ON)

Needle back and waste drain

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Syringe down Transfer tubing rinsing with ~0.5 ml (valve 11+14 ON) Dry the outside of the needle (valve 3 ON)

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Rocker move in the sampling position

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Syringe up Waste syringe drain (valve 7 ON)

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Needle down in sampling position

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Fluidic modules: Sampling module

Rep Part Number Designation 1 005-1001-02 01 Sampling module 2 005-1001-02 03 Rocker Motor 3 005-1001-02 02 Needle Motor 4 005-1001-02 04 Needle rinsing head 5 010-2501-02 05 Sampling Needle 6 312-0505-140 125 O-ring Ø1.4x1.25 Fluocarbon 80SH 7 010-2501-02 02 Needle carriage 8 353-0301-08 120 19 Belt pitch 2.032 (l=4.763-L=243.84) 9 005-1001-82 880 300 Needle Optical Sensor 10 363-0201-030 080 Screw K 30 x 8 11 360-0102-030 060 Screw RLX M3 x 6 12 360-0101-030 080 Screw CZX M3 x 8 13 005-1001-82 880 200 Rocker Optical Sensor 14 370-4050-030 10 Anti-loss washer Ø3 x 1

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Fluidic modules: Counting module

Rep 1 2 3 4 5 6 7

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Part Number Designation 005-1001-01 01 Counting chambers 010-2501-01 03 Counting manifold 005-1001-01 02 01 WBC Counting Head 005-1001-01 02 02 RBC Counting Head 312-0505-500 100 O-ring Ø5x1 Silicone 80SH 360-0101-030 060 Screw CZX M3 x 6 312-0505-1310 160 O-ring Ø13.1x1.6 Fluocarbon 80SH

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Fluidic modules: Syringe module

Rep Part Number Designation 1 002-1001-03 05 Syringes block 2 010-2501-03 06 Seal plate - Syringes module 3 010-2501-03 02 Piston Ø 16 - Syringes module 4 005-1001-03 03 Piston Ø 22 5 010-2501-03 01 Piston Ø 6.5 - Syringes module 6 005-1001-03 09 Syringe Piston Ø 1.6 7 312-0501-1554 262 O-ring Ø15.54x2.62 Silicone 60SH 8 312-0501-2189 262 O-ring Ø21.89x2.62 Silicone 60SH 9 312-0501-630 240 O-ring Ø6.3x2.4 Silicone 60SH 10 312-0505-140 125 O-ring Ø1.4x1.25 Fluocarbon 80SH 11 010-2501-03 10 O-ring spacer 12 363-0201-030 100 Screw K 30 x 10

Note1: For

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replacement of the O-rings on the syringe block, please refer to the Mythic™18 service manual. Note2: The O-rings on the seal plate of the syringes module are greased in the factory, as well as the pistons. It is very important that the greasing of these parts is maintained all the time. We recommend greasing the pistons every 6 months and the Orings once per year. The pistons can be greased by the customer. A default of greasing could be suspected in the following cases of troubles: -

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Trace of liquid under the syringes block. Leak of pressure. Abnormal noise during the movement of the pistons.

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Fluidic modules: Tubing connection

View n° 1 - Counting manifold

View n° 2 - Syringes manifold

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View n° 3 - Syringes body

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Fluidic troubleshooting: Clogging When could you suspect this problem? A clogging could be suspected in the following cases: -

Rejected result on WBC, RBC, PLT. Drop of blood on the needle.

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Rejected result on WBC, RBC, PLT:

The result of one or more parameters appears as below: WBC: --- * RBC: --- * PLT: --- * Or WBC: Value with “*” RBC: Value with “*” PLT: Value with “*” In any case, the flags “W_CL” or “R_CL” appear in the flag box below the results. W_CL means WBC Clog. R_CL means RBC/PLT clog. To fix the problem: 1/ Rerun the sample. 2/ If the problem continues, follow the next procedure:

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Service Menu

Hydraulic

Cleaning

End of service

OK

Run Sample NO Backflush

OK

Run Sample NO Bleach with hypochloride solution 10%

OK

Run Sample

NO

OK

1/ Dismantle the counting head. 2/ Remove the o-ring. 3/ Place the counting head in bleach solution for 10 minutes. 4/ Rinse the counting head with distilled water 5/ Replace the counting head

Replace the counting head by a new one

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-

Drop of blood on the needle.

When could you suspect this problem? It could happen that you observe a drop of blood falling from the needle after the blood aspiration. Note: As we explain before, none of the valves is used during this part of the cycle. So, it is not a problem of valve. To fix the problem: This problem appears when a clog is located in the rinsing head of the probe.

Rinsing head

Tubing n°10 : Aspiration tubing

Tubing n°21 : Diluent tubing

Follow the next procedure:

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Remove the rinsing head from the rocker

1/ 2/ 3/ 4/

Dismantle the needle, unscrew the roller which maintains the O-ring, remove the O-ring. Disconnect the 2 tubing: n°10 and 21

1/ Place the rinsing head in hypochloride solution for 5-10 minutes. 2/ Rinse it with distilled water

Replace the rinsing head and the needle. Don't forget the o-ring

End of service

OK

Run Sample

NO

Replace the tubing n°10, aspiration tubing.

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Fluidic troubleshooting: Leak of pressure When could you suspect this problem? -

HCT result rejected or too low (not proportional with Hb result). Impossible to recalibrate. Repeatability problem on the results. Message “Default Pressure”, follow with emergency stop.

How to fix problem with HCT results too low or repeatability problem? 1- Diagnosis Follow the next procedure:

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Login as Technician

Open the door of the instrument

Run analysis

Emergency stop when pistons on down position

1/ Service Menu 2/ Mechanics 3/ Check sensors

Check leak of liquid

PRESSURE STABLE

Check the value of the pressure. Should be stable along the time. If the pressure is decreasing, leak of pressure

PRESSURE UNSTABLE Dismantle the seal plate of the syringes module. 1/ If the o-rings are old, replace them by new ones. 2/ If not, grease the o-rings.

Repeatability

OK

Run Sample

NO

HCT calibration

OK

Change valve n°4

End of service

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Fluidic troubleshooting: Leak of pressure How to fix problem with “Default pressure” message? The message “Default pressure” is generated if the option “pressure checking” is activated in the menu “Set Up”, “Others settings”. This message is displayed if the system detects a default of vacuum during the counting cycle or during the drain cycle of the chambers. Different cases could activate this alarm: -

Diluent container empty (Option “Checking Reagents” not activated). Tubing disconnected. Leak on the waste syringe.

Before to perform a control cycle,

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

Check the volume of diluent in the container.



Open the door of the instrument and make a visual check of the fluidic part to detect any tubing disconnected or leak of liquid.

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Section 4: Mythic™22 Electronic      

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Learning Objectives. Electronic diagram. Boards description. Wiring description. Valves replacement. Electronic gain adjustment.

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Learning Objectives Section 4 will explain the Mythic™22 Electronic part. After reviewing this

section of the workbook you should be able to do the following:    

03/09/2009

List the 3 boards of the instrument. Describe how to replace a main board. Describe how to calibrate the touchscreen. Describe how to adjust the electronic gain.

- 67 -

Mythic™22 Electronic: General electronic diagram

03/09/2009

- 68 -

Mythic™22 Electronic: Main Board – Main components 03/09/2009

- 69 -

CMD Rocker

+60 V DC

CMD Nee

+3.3V DC

CMD Syring

CMD Count EV

+ 5V DC

Pulse proce logic DRAM

Printer driver

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microprocessor

Flash memory

Mythic™22 Electronic: Main Board – Voltage check points

+3.3 V DC

+ 5 V DC

+60 V DC

03/09/2009

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Mythic™22 Electronic: Preamplifier board

03/09/2009

- 72 -

Mythic™22 Electronic: GUI board & Calibration of the touchscreen

NOTE: It could be useful to recalibrate the touchscreen. To do this calibration:     

03/09/2009

Press in the same time on the numerical keyboard the key “.” and “DEL”. A cross appears on the display. Press in the middle of the cross. Proceed as previously with the next cross which appears. When the calibration is done, the display comes back to its initial status.

- 73 -

Mythic™22 Electronic: General wiring

03/09/2009

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Mythic™22 Electronic: Main wiring

Door switch

Syringe EV

Needle Optical Sensor

Counting EV

Rocker Optical Sensor

Needle motor

Motor syringe

Rocker motor

Syringe Optical Sensor

NOTE: For the wiring of the different parts (sensors, motors, valves …), please refer to the Mythic™22 service manual.

03/09/2009

- 75 -

Mythic™22 Electronic: Valves replacement Note: In order to proceed to the valves replacement we recommend using the following material:  Dynamometric screwdriver 15-75 cNm (Facom A.301MTJ1 or equivalent)  Torx plug 6 1. Counting chamber valves replacement

03/09/2009

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Mythic™18 Electronic: Valves replacement 2. Syringes module valves replacement

WARNING EV 3/2 Ø 1.6mm

03/09/2009

- 77 -

Mythic™22 Electronic: Electronic gain adjustment Note1: The electronic gain adjustment should be done after replacement of the following parts:    

Main board Preamplifier board Counting chamber Counting heads

Note2: The electronic gain adjustment doesn’t replace the calibration of the parameters with a blood calibrator.

03/09/2009

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Mythic™22 Electronic: Electronic gain adjustment 1.

2.

03/09/2009

WBC Latex (Diameter : 7µ) Spare Parts Changed

Action

PCB Board

WBC Electronic Gain Adjustment

Preamplifier Board

WBC Electronic Gain Adjustment

Counting Chamber

WBC Electronic Gain Adjustment

WBC counting head

WBC Electronic Gain Adjustment

Flow cell

Optical gain adjustment

RBC/PLT Latex (Mix 1/1 Diameter 3µ/5µ) Spare Parts Changed

Action

PCB Board

RBC/PLT Electronic Gain Adjustment

Preamplifier Board

RBC/PLT Electronic Gain Adjustment

Counting Chamber

RBC/PLT Electronic Gain Adjustment

RBC/PLT counting head

RBC/PLT Electronic Gain Adjustment

- 79 -

Mythic™22 Electronic: Electronic gain adjustment You need to login in TECHNICIAN MODE (enter the TECHNICIAN password). -

Select the SERVICE option Select the TECHNICIAN option And select PROD ADJUST

Report the diameter for WBC

Report the diameter for RBC and PLT

-

Shake the WBC LATEX with a VORTEX system Place the tube under the sample needle and press LATEX WBC

-

Wait the end of the cycle and check that values are inside the following range:

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Mythic 18

Gain

Mean Range

WBC

Between 210 and 242 Between 66 and 72

Mythic 22

Gain

WBC

Between 160 and 220 Between 53 and 72

Mean Range

-

Shake the RBC/PLT latex with a VORTEX system Place the tube under the sample needle and press LATEX RBC PLT

-

Wait the end of the cycle and check that values are inside the following range:

-

03/09/2009

Mythic 18

Gain

Mean Range

RBC

Between 210 and 250 Between 29 and 42

PLT

Between 215 and 250 Between 48 and 52

Mythic 22

Gain

RBC

Between 160 and 220 Between 38 and 50

PLT

Between 160 and 220 Between 48 and 65

Mean Range

When it is OK press VALID and confirm SAVING IN MEMORY

- 81 -

Electronic troubleshooting: WBC, RBC or PLT bad results?

03/09/2009

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03/09/2009

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Section 5: Mythic™22 mechanic   

03/09/2009

Learning Objectives. Syringe motor sub-assembly and greasing Sampling module and greasing

- 84 -

Learning Objectives Section 5 will explain the Mythic™22 mechanic part. After reviewing this

section of the workbook you should be able to do the following:   

03/09/2009

List the main mechanical parts of the instrument. Describe how to grease the main part of the syringe module. Describe how to grease the sampling module

- 85 -

Mythic™22 mechanic: Syringe motor sub-assembly

2 parts needs to be greased during the preventive maintenance: -

03/09/2009

The endless screw with the grease “Lubriplate DS-ES” ref. 410-0502-01. The guide of the pistons holder with the grease “Plastic grease SPG35” ref. 410-0503-01

- 86 -

Mythic™22 mechanic: Sampling module 2 parts could be greased during the preventive maintenance: -

Axis of the rocker  with the grease “Plastic grease SPG35” ref. 410-0503-01 The rail of the rocker  with the grease “Plastic grease SPG35” ref. 410-0503-01





03/09/2009

- 87 -

Section 6: Mythic™22 optical part     

03/09/2009

Learning Objectives. Optical manifold. Optical bench. Transverse adjustment. Optical electronic gain adjustment.

- 88 -

Learning Objectives Section 6 will explain the Mythic™22 optical part. After reviewing this

section of the workbook you should be able to do the following:   

03/09/2009

Describe how to change an entire optical bench. Describe how to perform the transverse adjustment. Describe how to adjust FSC and ALL gains.

- 89 -

Important Note:

Today only the complete optical module (Optical bench, P/N: 005-100201 01) or the flow cell (Optical flow cell P/N: 005-1002-02 01) can be replaced on customer site. It means that it is impossible to replace independently the illumination or detection sub-assembly which composes the optical bench and it is obvious that it is impossible to replace independently the different parts which compose these sub-assemblies. Those sub assemblies are adjusted in production area on a specific benchmark which allows to control each part independently and to adjust the complete optical bench. The only adjustment required after module or flow cell replacement is the transverse lens support adjustment, as we well see hereafter

03/09/2009

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Mythic™22 Optical part: Optical Manifold 1. Tubing position

2. Valves position

03/09/2009

- 91 -

Mythic™22 Optical part: Optical Manifold

Tubing 48: Note that it is very important in case of change of this tubing to respect the loop made by this tubing. The loop create a microbubbles catcher and avoid these bubbles go to the injector.

03/09/2009

- 92 -

Mythic™22 Optical part: Optical Manifold Troubleshooting No scattergram of too few points displayed on screen after blood analysis

1. Check all solenoid valves (Service > Mechanics > Check Valves>Open/close). You must hear distinctly the state changing. 2. Check the different steps in the WBC bath (empting, filling, dilution, homogenization, lysing, etc…) 3. Check if the tubing #48 makes the loop against the illumination part. This position avoid pushing micro bubbles in the injector during the measurement, those bubbles will stay in the high part of the loop and will be evacuated at the end of the cycle.

4. Check if the tubing #48 is emptied and filled properly during the cycle. a. At the beginning of the cycle, at the end of the WBC bath emptying, the tubing #48 must be completely empty. b. During the cycle, just after the second homogenization in the WBC bath, the tubing #48 must be completely filled with the blood sample present in the WBC bath. If it is not the case:   

03/09/2009

Check if the hydraulic “T” on the WBC bath is not damaged, which could cause a pressure difference. Check tubing # 56, 55 and 47 (refresh if necessary) Check tubing # 37, 5, 6 (they could be pitched when the fluidic door is closed, which could generate problems for the tubing #48 empting and filling)

- 93 -

Mythic™22 Optical part: Optical bench Optical Bench Functioning Generalities 1 Origin of the alignment Particles to be analyzed are transported by the 80µm cross section sample flow (see Fig. 2.3c), they have to pass the optical interrogation zone where light-particle interaction occurs. In order to get the best possible SNR (Signal Noise Ratio) for the optical measurement, dimensions of the optical interrogation zone have to be close to the sample flow diameter . Since optical interrogation zone is a rectangular area of 110µm  30µm and sample flow has a diameter of 80µm, their relative positioning has a tolerance of 15µm. Such a tolerance can not directly be reached when stacking the several mechanical parts of the optical bench: an alignment is thus required. So, the alignment basically comes from the need of high accuracy positioning of the light beam with respect to the sample flow. 2 Principle of the alignment In the Mythic22 optical setup, the flow cell is static (i.e. the sample flow position is fixed) but the light beam is shifted either longitudinally or transversally (see Fig. 2.2a) for the optical interrogation zone to match the sample flow. 2.1 Longitudinal alignment This is a factory done process which requires specific equipments. The longitudinal alignment is done once-for-all when the system is assembled and never requires further adjustment. In particular, maintenance or replacement of the flow cell has not impact onto longitudinal alignment.

>> Never release illumination module screws Mechanics > OPT. LED OFF/ON. If no, check if the CPU board sends the power supply on the led connector before to change optical bench (if no, change the CPU board) 

The CPU board is damaged. 



The FSC board is damaged. 



The transverse support adjustment is not possible. There is no pulse and no curve in the adjustment menu (OPTICAL ADJUST). Be careful if the FSC gain is too high the curve will be out of screen (input a default gain equal to 130).

The ALL board is damaged. 

03/09/2009

There is no pulse on the matrix result and you had checked all previous items. Replace the CPU board.

The transverse support adjustment is not possible. There is no pulse and no curve in the adjustment menu (OPTICAL ADJUST).

- 101 -

Mythic™22 Optical part: Optical bench troubleshooting TRANSVERSE SUPPORT ADJUSTMENT 

After complete module or just the flow cell replacement, run three empty cycles in order to remove all air bubbles from the optical hydraulic circuit.



Run a blood sample analysis and wait the result.



You must see the matrix on screen.



From the main menu, select “SERVICE”, “TECHNICIAN” and “OPTICAL ADJUST”.



Select « ADJUST LED » and wait the result of the adjustment.

WARNING: Be careful, this adjustment must be done with fluidic door closed. 

The transverse adjustment must be done after the instrument reaches the correct temperature.



Place the 7.0 µm latex solution in sample aspiration position.



In “OPTICAL ADJUST” select run and wait the result of the test.

03/09/2009

- 102 -

Note: The black and red curves must be located at the top position of the graph; they must be as smooth as possible and must be as close as possible. If it is the case, the transverse support doesn’t need any adjustment.

03/09/2009

- 103 -

 

Place the 7.0 µm latex solution in sample aspiration position. In “OPTICAL ADJUST” select «LATEX WBC» and wait the result of the test.



If it is not the case, gently release the transverse holder screw by executing 1 turn in CCW direction (Torx T06)

*    

Put the specific tool «Transverse Adjustment Tool» at its nominal position. Put the 7.0 µm latex solution in sample aspiration position. In “OPTICAL ADJUST” select run. When the curves appear, carefully turn the transverse holder in one way or the other, in order to define the best adjustment position which gives the best result regarding the black and red curves.

 

Repeat this operation as long as necessary to obtain the good result. When the adjustment is made, screw back the transverse holder fixation screw (1 turn in CW direction). Put back the Flow cell protection. Put the 7.0 µm latex solution in sample aspiration position. In “OPTICAL ADJUST” select «LATEX WBC» and wait the result of the test.

  

03/09/2009

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

Press on «VALID» in order to save in memory the gain adjustment result.

  

Back to the main menu and perform a run sample on the latex solution. At the end of the test, press on the screen to obtain a zoom of the matrix. You must get an oval mark in the left upper part of the screen as showed below.



Run sample with a fresh blood sample and wait for the result. WARNING: BE CAREFUL, THIS TEST MUST TO BE PREFORMED AT THE GOOD REGULATION TEMPERATURE, AFTER RECEPTION OF THE MESSAGE “TEMPERATURE REACHED”



At the end of the test, press on the screen to obtain a zoom of the matrix.



It is possible to obtain a matrix with the different populations out of the defined thresholds. To adjust properly the position of the matrix, you have to adjust manually the FSC and/or the ALL gains values. From the main menu, SERVICE, TECHNICIAN, COUNTING PARAMETERS.

 

Note: The matrix moves to the right when the FSC gain value increases, it moves to the left when the FSC gain value decreases. 03/09/2009

- 105 -

The matrix moves to the top when the ALL gain value increases, it moves to the bottom when the ALL gain value decreases.

Gains values 

Modify the FSC and/or the ALL gains values in order to put clusters in these respective boxes. (start with step of 10)



Press on “VALID” to confirm and “Yes” to save in memory.



Re-run the same blood sample to see the difference.



Adjust FSC and/or ALL gains values until you get the right matrix positioning in accordance with the thresholds.

03/09/2009

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03/09/2009

- 107 -

Section 7: Mythic™22 heater     

03/09/2009

Learning Objectives. Different parts of the Mythic™22 heater. How to dismantle the heater. Temperature flagging. How to unlock the Mythic™22.

- 108 -

Learning Objectives Section 7 will explain the Mythic™22 heating module. After reviewing this section of the workbook you should be able to do the following:   

03/09/2009

Describe how to dismantle the heater. Describe the different cases of locking the system. Describe how to unlock the instrument.

- 109 -

Mythic™22 heater: the different parts of the module.

Enclosure heater

Heating FAN

Diluent output

Reagent heater

Diluent input Lyse output Lyse input

Lyse heating circuit

Diluent heating circuit

03/09/2009

- 110 -

Mythic™22 heater: Temperature regulation and associated flagging Note: Three sensors detect the temperature inside and outside the Mythic™22. One is located in the enclosure, connected on the preamplifier board; one is located in the heater; the last one is located under the reagent tray to detect the room temperature. SENSOR REAGENT

OBSERVED TEMPERATURE No increasing during 5 min.

REAGENT

> 60°C

REAGENT

> 70°C

ENCLOSURE

No increasing during 5 min.

ENCLOSURE

> 50°C

ENCLOSURE

> 55°C

AMBIANT

< 17°C

AMBIANT

> 35°C

REAGENT/ENCLOSURE

< 34°C or > 45°C

03/09/2009

ACTION

MESSAGE

M22 Switch Off Heater Stopped

Heat Reagent Failure Hardware: Heat reagent stopped Hardware: Heat reagent Failure

M22 Switch Off M22 locked M22 Switch Off Heater Stopped M22 Switch Off M22 locked Sampling needle not go down Sampling needle not go down Sampling needle not go down

- 111 -

RUN ANALYSIS/CAL/QC NO NO

NO

Heat Enclosure Failure Hardware: Heat enclosure stopped Hardware: Heat enclosure Failure

NO

Temperature out of range

NO

Temperature out of range

NO

Temperature out of range

NO

NO

NO

Mythic™22 heater: How to unlock the system Note: when the system is locked, only the service engineer can unlock it. To unlock the instrument, enter the service password (2TEC), and then follow the next procedure.

Service Menu

Technician Menu

Thermal

Press on "Unock Heat"

The system is unlocked, Check the temperature sensors in "Check Sensors" in the Mechanic Menu.

03/09/2009

T° doesn't increase correctly

Temperature increases correctly

Change the heater

Heater is Ok, preamplifier board or Main board defective (Depending on the alarm)

- 112 -

Section 8: Mythic™22 Technical Notes

03/09/2009

- 113 -

INSTALLATION RECOMMENDATIONS

Objective of this technical note: To give the distributors a guide line to install in good conditions the Mythic 22 OT. Notice: temperature in the Lab must be between 20° C and 30°C max The power current with the Mythic must be grounded or (and) the back of the instrument is grounded properly

Procedure: 1234-

Unpack the system Plug the power supply Plug reagents Open the door a. Remove the foam b. Check needle in the correct position c. Check counting chamber and counting head in correct position and close the door. 5- Switch on 6- Technician password 7- Set-Up: a. Date/time in local format b. Printer (if needed) c. Print-Out options d. Lab parameters (if needed) e. Others options: i. Autoclean (depend off the load of the instrument: 50 samples/day = 25) ii. Wake up (min. 30 minutes before sampling work) iii. Shut down time (time after last measurement, depend of laboratory schedule and workload ) f. Storage Options: FIFO mode activated if memory stick don’t use.

03/09/2009

- 114 -

8- Reagents : a. Expiry date b. Lot number c. Volume Waste: capacity (stand on the floor) 9- Diluent: always stand at same level of the machine. 10- Prime All x 2 11- Start-up (check ground values following the user manual) 12- Calibration ( 3 replicates at least) 13- QC 14- Repeatability (check CV, report to the user’s manual for acceptable range )

03/09/2009

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Adjustments to perform using latex and G-Cal Objective of this technical note: Make a summary of the different adjustments to perform after a service or maintenance on Mythic 22 and 22 CT.

Procedure: 1- With WBC latex if change of: a. b. c. d. e. f.

CPU Board Preamplifier board WBC counting head Counting chamber Flow cell Optical bench

2- With RBC latex if change of: a. b. c. d.

CPU board Preamplifier board RBC counting head Counting chamber

3- With G-Cal if change of: a. Flow cell b. Optical bench

WARNING: When latex is performed to adjust the WBC, RBC and PLT gain, it is important to calibrate these parameters using Myt-CAL from Orphée.

03/09/2009

- 116 -

MAINTENANCE PROGRAM Objective of this technical note: To define a maintenance program for Mythic 22 OT, in order to avoid problems on the system. To define a guideline applicable by every service engineer.

Procedure:

03/09/2009

- 117 -

Workload < 50 samples/day Every 4 months

Short maintenance program

Check points: Greasing:

O-ring needle (rinsing head) O-ring counting head All tubing connections Connectors preamplifier board – counting chamber Adjust HGB, check the value between 800 – 900 Adjust LED (optical adjust), higher than 250

Mechanical grease: -

Endless screw Guide piston motor Guide needle

Plastic grease: - Guide endless screw - Rocker guide - Rocker wheel Silicon grease: -

03/09/2009

Syringes O-ring counting chamber

- 118 -

Cleaning: -

Counting chambers (be careful with the electrode inside the chamber) Screen Bleach

Adjustment: -

03/09/2009

WBC and RBC/PLT latex check. If needed, calibration. Latex WBC optical (every 2 maintenances): See Mythic 22 workbook for the full description of the procedure. G-Cal. See TB-09-01 for the procedure

- 119 -

Workload > 50 samples/day Or 24 hours to 24 hours Every 3 months

Short maintenance program

Check points: -

O-ring needle (rinsing head) O-ring counting head All tubing connections Connectors preamplifier board – counting chamber Adjust HGB, check the value between 800 – 900 Adjust LED (optical adjust), higher than 250

Greasing: Mechanical grease: - Endless screw - Guide piston motor - Guide needle Plastic grease: -

03/09/2009

Guide endless screw Rocker guide Rocker wheel

- 120 -

Silicon grease: -

Syringes O-ring counting chamber

Cleaning: - Counting chambers (be careful with the electrode inside the chamber) - Screen Bleach Adjustment: -

03/09/2009

WBC and RBC/PLT latex check. If needed, calibration. Latex WBC optical (every 2 maintenances): See Mythic 22 workbook for the full description of the procedure. G-Cal. See TB-09-01 for the procedure

- 121 -

Workload < 50 samples/day Every two years

Main maintenance program

Change: - All of the tubings (tubing kit) - All of the O-rings (O-ring kit) Dismantling: - All valves and check Greasing: Mechanical grease: - Endless screw - Guide piston motor - Guide needle Plastic grease: - Guide endless screw - Rocker guide - Rocker wheel Silicon grease: -

03/09/2009

Syringes O-rings

- 122 -

Cleaning: - Counting chambers (be careful with the electrode inside the chamber) - Screen - Bleach Adjustment: -

03/09/2009

WBC and RBC/PLT latex check. Calibration. Latex WBC optical (every 2 maintenances): See Mythic 22 workbook for the full description of the procedure. G-Cal. See TB-09-01 for the procedure

- 123 -

Workload > 50 samples/day Or 24 hours to 24 hours Every year

Main maintenance program

Change: - All of the tubings (tubing kit) - All of the O-rings (O-ring kit) Dismantling: - All valves and check Greasing: Mechanical grease: - Endless screw - Guide piston motor - Guide needle Plastic grease: - Guide endless screw - Rocker guide - Rocker wheel Silicon grease: -

Syringes O-rings

Cleaning: - Counting chambers (be careful with the electrode inside the chamber) - Screen - Bleach Adjustment: 03/09/2009

WBC and RBC/PLT latex check. Calibration. Latex WBC optical (every 2 maintenances): See Mythic 22 workbook for the full description of the procedure. G-Cal. See TB-09-01 for the procedure - 124 -

List of spare parts, reagents and tools required: -

Minimum Tools: o o

-

Spare Parts: o o o o o o

-

03/09/2009

M18-M22-M22CT O-rings kit, code number: 002-1005-50 10 Mythic 22 Tubing kit, code number: 002-1002-50 11 Kit latex, code number: 465-0110-05 Silicon Grease, code number: 410-0501-01 Lubriplate DS-ES, code number: 410-0502-01 Plastic Grease SPG35, code number : 410-0503-01

Reagents: o o o

-

Torque driver with plug of 6, 10 and 20. Flat screwdriver.

Myt-Cal, code number: Myt-Cal2 Myt-5D Normal level or tri level, code number: Myt506 or Myt502 G-Cal, code number: G-Cal

Bleach solution (hypochlorite solution), max. 10% of chloride. Distilled water. Last updated version of software.

- 125 -

Sensors and electronic gain values

Check sensors menu: -

-

Pressure:  0 in standby mode WBC < 15 (little fluctuations are normal) RBC < 25 (little fluctuations are normal) HGB: o LED OFF and all the covers closed: 0 o LED ON and all the covers closed: 800 to 900 FSC (LED ON):  200 Reagent temperature: 34°C (must be in accordance with thermal setting) Enclosure temperature: 36°C (must be in accordance with thermal setting) Both set of temperatures: AUTO mode.

Gain Values, Results reading and channels in Prod Adjust and Optical Adjust Parameters Optical LED HGB LED RBC PLT WBC

03/09/2009

Gain Values 0 - 255 150 - 255 160 – 220 160 – 220 160 – 220

Results reading ≥250 800 – 900

- 126 -

Channels

Comments

43 55 59

Depends on diameter Depends on diameter Depends on diameter

How to use and interpret the ratio O-CL (Only available from version 2.3.0)

With super-technician password, the ratio for the optic is added from Run Sample Menu. See description below to check this value.

i. From patient result, press on the scatter gram to focus on it.

ii. From the focus, press on DIF.

03/09/2009

- 127 -

iii. Check the ratio in O-CL.

iv. How to interpret the value O-CL? If the ratio is low (