11 03 04 004 02 User Manual M60 V2 en PDF

Mythic 60
User’s Manual
MYTHIC 60 Copyright© Orphée SA. All Rights Reserved. Page 1/118
REVISIONS
Revision Nb Date Author Software Comments

01 25/09/19 ML Document creation V1
02 14/11/19 KZ/SK V 0.7.3. All sections updated.
CONTACT ADDRESS
MANUFACTURER
Manufactured in Germany for:
ORPHEE SA
19, chemin du champ des filles
CH-1228 Geneva / Plan-les-Ouates
SWITZERLAND
Tel : +41 (0) 22 706 1840

Fax : +41 (0) 22 794 4391
http://www.orphee-medical.com
LOCAL AGENT

Table of contents
CONTACT ADDRESS .................................................................................................................................................. 2
MANUFACTURER ......................................................................................................................................................... 2
LOCAL AGENT .............................................................................................................................................................. 2
Chapter 1 SAFETY GUIDANCE ................................................................................................................................. 6
1.1 Symbols and Definitions .................................................................................................................. 6
1.2 Warnings and Cautions .................................................................................................................... 7
Chapter 2 GENERAL OVERVIEW ............................................................................................................................. 9
2.1 Introduction ...................................................................................................................................... 9
2.2 Main Parts ....................................................................................................................................... 10
2.2.1 Front cover ........................................................................................................................... 10
2.2.3 Reagent area ........................................................................................................................ 12
2.2.4 Connection board ................................................................................................................ 12
2.2.5 External power supply block ............................................................................................ 13
2.2.6 Printer ................................................................................................................................... 13
2.2.7 External Barcode reader & keyboard ............................................................................ 13
2.3 Configuration .................................................................................................................................. 13
2.3.1 Standard Configuration starter kit ................................................................................ 13
Chapter 3 INSTALLATION GUIDANCE .............................................................................................................. 14
3.1 Installation Requirement.............................................................................................................. 14
3.1.1 Location .................................................................................................................................. 14
3.1.2 Installation environment ................................................................................................... 14
3.2 Unpacking ........................................................................................................................................ 14
3.2.1 Unpacking Procedure ................................................................................................................. 14
3.2.2 Visual check .......................................................................................................................... 15
3.3 Installation...................................................................................................................................... 15
3.3.1 Electric and Hydraulic connections................................................................................. 15
3.3.2 User’s Identification ........................................................................................................... 19
3.3.2.1 Log in screen ..................................................................................................................... 19
3.3.2.2 Rights of access............................................................................................................... 20
3.3.3 Main screen .......................................................................................................................... 21
3.3.4 Reagent setting ................................................................................................................... 23
Chapter 4. STATS ...................................................................................................................................................... 26
4.1 Introduction .................................................................................................................................... 26
4.2 Qc...................................................................................................................................................... 26
4.2.1 Change .................................................................................................................................... 27
4.2.2 Load........................................................................................................................................ 28
4.2.3 Results ................................................................................................................................... 29
4.2.4 Levey-Jennings graph ........................................................................................................ 30
4.2.5 Details ................................................................................................................................... 31
4.3 Calibration ....................................................................................................................................... 32
4.3.1 Change .................................................................................................................................... 32
4.3.2 Results ................................................................................................................................... 33
4.3.3 Load ..................................................................................................................................... 37
4.4 Repeatability .................................................................................................................................. 38
Chapter 5 RUN SAMPLE ........................................................................................................................................... 39
5.1 Introduction .................................................................................................................................... 39
5.2 Run sample ................................................................................................................................ 40
5.2.1 Run Sample – Sample Information & Sampling/Analysis Mode .................................... 40
5.2.2 How to run with patient blood analysis.............................................................................. 43
5.2.3 Understand Results ................................................................................................................ 44
Chapter 6 TECHNOLOGY ......................................................................................................................................... 47
6.1 Detection Principle WBC, RBC, PLT Counting .......................................................................... 47
6.2 Five-part diff measurement. ...................................................................................................... 48
6.3 Hemoglobin Measurement ........................................................................................................... 49
6.4 Leukocyte Analysis ........................................................................................................................ 49
6.5 Erythrocyte Analysis .................................................................................................................... 51
6.6 Platelet Analysis ............................................................................................................................ 53
6.7 Alarms .............................................................................................................................................. 54
6.7.1 General Flags ........................................................................................................................ 54
6.7.2 Leukocytes Flags................................................................................................................. 55
6.7.3 Erythrocyte and HGB Flags ............................................................................................. 57
6.7.4 Platelet Flags ....................................................................................................................... 58
6.7.5 System Alerts .................................................................................................................. 59
6.7.5.1 INS-T / Instrument Temperature Out Of Range ............................................ 59
6.7.5.2 WBC BAL / WBC Balance ........................................................................................ 59
6.7.5.3 WBC-CL / WBC Aperture Clog .............................................................................. 59
6.7.5.4 RBC-CL / RBC Aperture Clog.................................................................................. 59
6.7.5.5 O-DF / Optical Default ........................................................................................... 59
6.7.5.6 SU-F / Startup Failed ............................................................................................. 59
6.7.5.7 QC Not Done / QC Not Done During The Day................................................... 59
6.7.5.8 QC Failed / Last Run QC Failed ............................................................................ 59
6.8 Hydraulic Description ................................................................................................................... 60
6.8.1 Sampling module .................................................................................................................. 61
6.8.2 syringe module ..................................................................................................................... 61
6.8.3 Syringe valve module ......................................................................................................... 61
6.8.4 Counting module .................................................................................................................... 61
6.8.5 Optical Bench ...................................................................................................................... 61
6.9 Software ......................................................................................................................................... 61
6.9.1 Graphical User Interface.................................................................................................. 61
6.9.2 Windows ................................................................................................................................ 62
Chapter 7 SPECIFICATIONS ................................................................................................................................. 63
7.1 Analytical Specifications ............................................................................................................. 63
7.1.1 Linearity ................................................................................................................................. 63
7.1.2 Background............................................................................................................................ 64
7.1.3 Precision ................................................................................................................................ 64
7.1.4 Carry-Over ............................................................................................................................ 65

7.1.5 Correlation ............................................................................................................................ 66
7.2 Units........................................................................................................................................... 67
7.3 Reagent consumption .................................................................................................................... 68
7.4 Physical Specifications ................................................................................................................ 69
7.4.1 Instrument Specifications ................................................................................................ 69
7.4.2 Power Supply Block ............................................................................................................. 69
7.5 Reagents Specifications .............................................................................................................. 70
7.5.1 Diluent for Mythic 22 ........................................................................................................ 70
7.5.2“OnlyOne” .............................................................................................................................. 71
7.5.3 Cleaner for Mythic 22 ....................................................................................................... 72
7.5.4 Mythic 18-22 FLUSH – CLEANER .................................................................................. 73
7.6 Analytical Limitations ................................................................................................................... 74
7.6.1 Interferences ...................................................................................................................... 74
Chapter 8 RESULTS .................................................................................................................................................. 75
8.1 Introduction .................................................................................................................................... 75
8.2 Results ....................................................................................................................................... 75
8.2.1 Date..................................................................................................................................... 76
8.2.2 Details .................................................................................................................................. 77
Chapter 9 SERVICE ................................................................................................................................................... 78
9.1 Introduction .................................................................................................................................... 78
9.2 system init....................................................................................................................................... 78
9.3 Logs ................................................................................................................................................... 78
9.3.1 Event logs .............................................................................................................................. 78
9.4 error log........................................................................................................................................... 79
9.5 backup & restore ........................................................................................................................... 80
9.5.1 backup .................................................................................................................................... 80
9.5.2 restore .................................................................................................................................. 80
9.6 settings ............................................................................................................................................ 81
9.6.1 Lab parameters .................................................................................................................... 81
9.6.1.1 Lab preferences ............................................................................................................... 82
9.6.1.2 units .................................................................................................................................... 84
9.6.1.2.1 US Format & units .................................................................................................... 84
9.6.1.2.2 SI Format & units ..................................................................................................... 84
9.6.1.2.3 SI Mode Format & units: ........................................................................................ 85
9.6.1.2.4 Japanese Format & units: ....................................................................................... 85
9.6.1.3 CBC Thresholds and flags .............................................................................................. 85
9.6.1.4 DIF Thresholds and flags .............................................................................................. 86
9.6.1.5 References ranges ........................................................................................................... 86
9.6.1.6 Calibration Factors .......................................................................................................... 87
9.6.2 Date & Time ......................................................................................................................... 88
9.6.3 Automatic cycles ................................................................................................................ 89
9.6.4 Printer ................................................................................................................................... 90
9.6.4.1 Printer settings ................................................................................................................ 90
9.6.4.2 Printer management........................................................................................................ 91
9.6.5 Communication ..................................................................................................................... 93
9.6.6 Users management ............................................................................................................. 94
9.6.6.1 Add ...................................................................................................................................... 95
9.6.6.2 Change Password ............................................................................................................. 95
9.6.6.3 Remove ............................................................................................................................... 95
9.6.7 Software update ................................................................................................................. 95
9.7 TROUBLESHOOTING ................................................................................................................. 97
9.7.1 Fluidics controls .................................................................................................................. 97
9.7.2 Flush cleaning ...................................................................................................................... 98
9.7.3 Drain baths .......................................................................................................................... 99
9.7.4 Backflush apertures........................................................................................................... 99
9.7.5 Backflush optical bench flowcell ..................................................................................... 99
9.7.6 Needle dismantling ............................................................................................................. 99
9.7.7 Check rocker ...................................................................................................................... 101
9.7.8 Park motor syringes ......................................................................................................... 101
9.7.9 Rinse .................................................................................................................................... 101
9.7.10 Clean ................................................................................................................................... 101
9.7.11 Clean and Drain for pack up the instrument ............................................................. 101
9.7.12 Syringes greasing............................................................................................................ 102
9.7.13 Check sensors and valves .............................................................................................. 103
9.7.14 Check syringes ................................................................................................................. 105
9.7.15 Check needle .................................................................................................................... 105
Chapter 10 MAINTENANCE .................................................................................................................................. 106
10.1 Analytical problems ................................................................................................................... 107
10.2 Other problems ..................................................................................................................... 107
10.3 Troubleshooting Messages ...................................................................................................... 108
Chapter 11 SHUTDOWN ......................................................................................................................................... 118
Chapter 1 SAFETY GUIDANCE
1.1 Symbols and Definitions
WARNING RISK OF DANGER. Indicates a procedure to be strictly respected in order to

avoid any risk for the user, damage on the instrument or on the result’s quality.
Indicates that wearing gloves is mandatory before performing the described operation due to
risk of contact with materials that may be infectious.
NOTE Indicates important information

Indicates that this product may not be treated as household waste. Instead it shall be handed
over the applicable collection point for the recycling of electrical and electronic equipment. By
ensuring this product is disposed of correctly, you will help prevent potential negative
consequences for the environment and human health, which could otherwise be caused by

inappropriate waste handling of this product. For more detailed information about recycling of
this product, please contact your local city office or your distributor of this product.
1.2 Warnings and Cautions
NOTE: Misuse of electrical equipment may cause electrocution, burns, fire and other hazards.
Check if the voltage setting matches the supply voltage.
Connect MYTHIC 60 power supply block to main power supply outlet with an earth connection.
Preserve a good access to the supply outlet to be able to unplug MYTHIC 60 in emergency case.
Do not place the power supply adapter in liquid, nor put it where it could fall into liquid. If the power
supply adapter becomes wet, unplug it before touching it.
Do not use MYTHIC 60 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).
Do not let the power supply adapter or its flexible cord meet surfaces which are too hot to touch.
Do not place anything on top of MYTHIC 60.
Do not use MYTHIC 60 where aerosol sprays are being used, or where oxygen is being administered.
Do not use MYTHIC 60 outside.
Always switch off MYTHIC 60 and disconnect the power adaptor before dismantling any part.
NOTE: MYTHIC 60 is an automated hematology analyzer for in vitro diagnostic use in clinical
laboratories by a representative people.
Only human blood or artificial control and calibration blood must be run.
The optimum performances can be only achieved if the cleaning and maintenance procedures are
strictly respected.
Due to the use and the environment of this equipment, all parts and surfaces of MYTHIC 60 are
potentially infective. Wearing gloves and hands washing after work completion are strongly
recommended.
Always replace or use parts of the equipment by original parts.
Basic safety precautions should always be taken. If the equipment is not used per the
manufacturer’s instructions, the protective by the equipment may be impaired.
The treatment of waste and the elimination of a part or the complete instrument must be done in
compliance with the local legislation.
Any output or input connections (except the printer and the barcode reader) cannot be done without
representative authorization.
Do not open the door located on the right side of the instrument when hydraulic cycle is in progress,

it will lead to an immediate stop.

Chapter 2 GENERAL OVERVIEW
2.1 Introduction
Mythic 60 is a fully automated analyzer performing hematological analysis on whole blood collected on
EDTA tubes.
Sampling volume is 15.6 µl and analysis cycle duration is 60 seconds.
NOTE: Result is displayed and printed before the end of the analysis cycle.
Here below the list of all parameters determined by the analyzer for each analysis:
White blood cell parameters: Determination

Symbol Description
WBC Total Count Measured
LYM%/# Lymphocyte percent and absolute value Measured/Calculated
MON%/# Monocyte percent and absolute value Measured/Calculated
NEU%/# Neutrophil percent and absolute value Measured/Calculated
EOS%/# Eosinophil percent and absolute value Measured/Calculated
BAS%/# Basophils percent and absolute value Measured/Calculated
ALY%/#* Abnormal Lymphocyte percent and absolute value Measured/Calculated
IMM%/#* Immature Monocyte percent and absolute value Measured/Calculated
Red blood cell parameters: Determination

Symbol Description
RBC Total count Measured
HGB Hemoglobin Measured
HCT Hematocrit Measured
MCV Mean Cell Volume Calculated
MCH Mean Cell Hemoglobin Calculated
MCHC Mean Cell Hemoglobin Concentration Calculated
RDW-CV Red Blood Cells Distribution Width-CV Calculated
RDW-SD Red Blood Cell Distribution Width-SD Calculated
Platelet parameters: Determination

Symbol Description
PLT Total count Measured
MPV Mean Platelet Volume Calculated
PCT* Plateletcrit Calculated
PDW* Platelets Distribution Width Calculated
P-LCR* Large Platelets Counts Ratio Calculated
Note: Parameters followed with (*) are RUO (Research Use Only), to be displayed the option must
be activated.

2.2 Main Parts
MYTHIC 60 consist of the seven main parts listed below:
1. Front cover.
2. Fluidic part.
3. Reagent area.
4. Connection board.
5. External power supply block.
6. Printer (optional).
7. External Barcode reader.
2.2.1 Front cover

The front cover consists of the five elements listed below:
1. Touch screen LCD display (8.4”).

2. ON/OFF & EMERGENCY STOP button.
3. Start analysis cycle trigger.
4. USB port connection.
5. CPU board located behind the screen.

2.2.2 Fluidic part
The fluidic part is located on the right side of the instrument directly accessible after opening of
the fluidic door.
The fluidic part consists of the six elements listed below:
1. Sampling module.
2. Syringe module.
3. Syringe valve module.
4. Counting chambers.
5. Counting valve module.
6. Optical Bench.
1
3

2.2.3 Reagent area
The reagent area is located on the left side of the instrument directly accessible after opening of the
reagent door. The reagent area is dedicated for lyse & cleaner reagent bottles.
2.2.4 Connection board

The connection board is located at the back of the instrument and allows different types of connections
described below.
4 USB Ports
TP/TCIP Port
Serial Link RS232

Port
Not Used
P/S 24V

2.2.5 External power supply block
MYTHIC 60 is supplied with an external power supply block. •
100-240 VAC
• 50/60 Hz
• Single phase with ground
• 24VDC/6.67A (160W)
In the case of replacement of the main power cord supplied with MYTHIC 60, the
new cord must comply with the local regulation.
MYTHIC 60 have been certified with the power supply block provided with. Use with
another external power supply block is not guaranteed.
2.2.6 Printer
MYTHIC 60 is not delivered with the printer. The instrument is equipped already with PCL3 & PCL6
standard protocol printer drivers which cover compatible printer models. Here below examples of
printers compatible with the instrument. It is not an exhaustive list:
EPSON M100/M105/M200/M205
HP1102w/1106/1108
Lexmark CS310/MS410.
2.2.7 External Barcode reader & keyboard

An external barcode reader is provided and is included with the delivery box.
Connected to an USB port of MYTHIC 60, it allows entering automatically the following fields:
 Sample identification SID.
 Reagent identification (LYSE, CLEANER and DILUENT).
 QC and calibration lot number.
NOTE: The Automatic barcode identification is available only for these fields.
An external keyboard is not provided.
2.3 Configuration
2.3.1 Standard Configuration starter kit
• 1 analyzer
• 1 power cord
• 1 power supply block
• 1 flat screwdriver
• 1 certificate of approval
• 1 diluent pick up tubing
• 1 waste tubing
• Maintenance kit
• 1 USB Barcode scanner

Chapter 3 INSTALLATION GUIDANCE
3.1 Installation Requirement
3.1.1 Location
To ensure MYTHIC 60 fulfills its function, it must be installed on strong and stable table which
supports the weight of the unit as well as the one of the printer and reagents (around 30 Kg). Ten
centimeters space at the rear of the instrument and 30 centimeters on each side are required for
maintenance tasks and reagents change. Exposure to direct sunlight shall be avoided as well exposure
to close neon light or any apparatuses which could create magnetic or high frequency disturbances.
3.1.2 Installation environment

• Indoor use.
• Altitude up to 3000 meters.
• Using temperature [18 °C to 32 °C].
Note: If the ambient temperature moves more than 10°C during the working day, MYTHIC 60
must be calibrated more frequently.
• Maximum relative humidity for temperatures up to 31 °C is 80 %, decreasing linearly to 50 % at

40 °C.
• Main power supply voltage fluctuations up to ±10 % of the nominal voltage.
• Transient over voltages typically present on the main supply.
• Rated pollution degree II.
Contact your distributor to use the MYTHIC 60 in other conditions than the ones
described above. Please take care of reagents temperatures constraints.
3.2 Unpacking
3.2.1 Unpacking Procedure
MYTHIC 60 is delivered in a cardboard. It is recommended to examine the package visually before

unpacking. If there is any sign of mishandling, damage or else, contact the carrier to claim for damage.
During device unpacking, person in charge of the installation must control the good presence of all
elements needed for installation comparing to the PACKING LIST.
Installation of the device must be done according to the procedure described hereafter.

3.2.2 Visual check
Open the fluidic door on the right side with the screw driver provided in the kit and check the following
items:
 Syringes pistons located in top position.
 Sampling module located on front.
 Needle rinsing dismountable system

well locked on the sampling module.
If MYTHIC 60 has been stored at a temperature less than 10°C, it must stay at
room temperature during 24 hours to let the time all elements to reach the ambient
temperature before switching it on.
3.3 Installation
This instruction describes the different stages to follow for the physical installation of MYTHIC 60
instrument.
3.3.1 Electric and Hydraulic connections.
1. Remove the instrument from the cardboard and place it on a stable table.

2. Remove the accessories boxes from the reagent
compartment and unpack the elements.
Control the presence of all elements comparing to the packing list.
Whether any element would be missing, contact immediately your ORPHEE distributor.
Before handling the reagents, read carefully their specifications described in section.
3. Connect the diluent pickup tubing to the dedicated hydraulic connector located at the back of
the instrument.
To connect the diluent pick up

tubing, place the two hydraulic
connectors face to face and turn
clockwise the one of the diluent
pickup tube.

4. Connect the waste tubing to the red hydraulic connector located at the back of the instrument.
To connect the waste tubing, place

the two hydraulic connectors face
to face and turn anticlockwise the
red one of the instrument.
5. Tighten the cap of the Lyse pickup tubing (Yellow

color sleeve) and the cap of the Cleaner pickup tubing
(Blue sleeve) to the dedicated bottles.
6. Install lyse and cleaner bottles in the reagent

compartment of the instrument.
7. Connect the diluent pickup tubing to the diluent

container.
DILUENT CONTAINER MUST ALWAYS BE PLACED ON THE SAME LEVEL THAN

THE INSTRUMENT. NOT ON THE FLOOR.
8. Place the waste straw into a waste container.
WASTE CONTAINER MUST ALWAYS BE PLACED ON FLOOR UNDER THE

INSTRUMENT.

MYTHIC 60 works exclusively with the reagents described in section 4.3. Orphee’s
or its local representative will not be responsible for the quality of the results and
for the maintenance of the instrument if other commercial reagents are used.
Warranty does not cover any defect, malfunction or damage due to failure to use the
inappropriate reagents or chemicals specified for the product.
 Do not modify the type and the length of the diluent and waste tubes.
 Collect the waste in a container preferably placed on the floor and treat it in
compliance with your local legislation.
Example of neutralization procedure usually used in a laboratory for waste material:
For 20 liters of waste, produced by the MYTHIC 60, add 50 ml of a solution of sodium hydroxide
(NaOH) at 200g/l, mix the container, add 100ml of bleach at 36°C, mix the container, wait one hour
before empty it.
Only use this procedure if there is no specific local legislation for the treatment of
the waste.
9. Connect the power supply cable coming from the power

supply block to the instrument respecting the connection
way as shown on the picture.
MYTHIC 60 has been certified with the power supply block provided with.
Any use of another external power supply block could not be guaranteed.
10. Connect the main cord to the power supply block.

Very good earth connection of socket-outlet power is required.
In the case of change the power cord provided with the instrument, the replacing
cord must be in compliance with the local regulation and the instrument specification
in matter of consumption.
NOTE: The power supply block must be placed at the rear of MYTHIC 60 and if possible, upper
than instrument level to avoid any risk of contact with liquid.

11. Connect the main cord to a plug of the main power supply.
• 100-240 VAC
• 50/60 Hz
• Single phase with ground.
12. Switch on the instrument by pressing the start button and wait for loading until the display of
the login screen.
3.3.2 User’s Identification
3.3.2.1 Log in screen
Regarding login, two different levels of access are available, BIOLOGIST AND USER.
Thereafter, additional access level could be created.
USER level is the more limited in terms of access.
It is possible to create, change or modify ID and/or associated password for Biologist and User
access levels only (see describtion of ADMINUSER screen).
▪ Biologist: Operator ID = BIOLO, Password = 123456

▪ Operator: To be defined in ADMINUSER screen.
If one field is empty, error

message is displayed.
If one field is wrongly filled,

error message is displayed.

Enter your Operator ID and Password using the Alpha-Numeric keyboard displayed on screen or
the external keyboard.
Press on to access to the main menu.
3.3.2.2 Rights of access
ARBORESCENCE ACCESS
MENU SUB-MENU FUNCTION OPERATOR ADMINISTRATOR TECHNICIAN
STARTUP
SHUTDOWN
CHANGE LOAD
QC LJ GRAPHS
RESULT
DETAIL
CHANGE
STATS
CALIBRATION RESULT Calibrate
LOAD
DEL.UNSELECT
REPEATABILITY
DETAIL
RUN SAMPLE NEXT SAMPLE
DATE
RESULTS
DETAILS
PRIME ALL
DILUENT PRIME
LYSE PRIME
REAGENTS CLEANER PRIME
WASTE RESET
Cycle Counters RESET
Reagents Log
SYSTEM INIT
EVENT LOGS
ERROR LOGS
BACKUP
BACKUP & RESTORE
RESTORE
LAB PREFERENCES
UNITS
CBC TRHESHOLDS AND
FLAGS
LAB PARAMETERS
DIFF TRHESHOLDS AND
FLAGS
REFERENCE RANGES
CALIBRATION FACTORS
SETTINGS DATE AND TIME
AUTOMATIC CYCLES
PRINTER SETTINGS
PRINTER
PRINTERS MANAGEMENT
COMMUNICATION COMMUNICATON SETUP
ADD
USERS MANAGEMENT CHANGE PASSWORD
REMOVE
SOFTWARE UPDATE
FLUIDIC CONTROL
SERVICE
BLEACH CLEANING
DRAIN BATHS
BACKFLUSH APERTURES
BACKFLUSH OPT.
BENCH
NEEDLE DISMANTLING
CHECK ROCKER
PARK MOTORS
RINSE
CLEAN
DRAIN FOR PACK UP
TROUBLESHOOTING
SYRINGE GREASING
DRAIN FLOW CELL
EV1-x
ALL EV ON
EV CHASER
CHECK SET HGB LED OFF
SENSORS/VALVES SET CO ON
SET OPT LED ON
TEST VACUUM
PUMP ON
CHECK SYRINGE
CHECK NEEDLE

ADJ. LED
ADJ. OB
ADJUST DIF CHECK OB
ADJ.WBC
CHECK WBC
WBC ADJUST
TECHNICIAN
WBC CHECK
RBC ADJUST
ADJUST OTHERS
RBC CHECK
HGB ADJUST
PRESSURE ADJUST
SYSTEM CONFIG
LOG OUT
3.3.3 Main screen
The main menu is displayed immediately after validation of the login screen.
From this screen it is possible to access to the following sub-menus:
▪ STATS,
▪ RUN SAMPLE,
▪ RESULTS,
▪ REAGENTS,
▪ SERVICE.
Start up cycle must be launched every

day after switch on the instrument.
Shutdown cycle must be launched

every day to switch off the instrument.
Note : All menus and sub-menus are displayed with the same header as described below.
▪ Will go back to the previous sreen in menu structure.
▪ Depending on the screen, will gain access to the following options.
Send results data to the host computer.
Make a printout.
Delete the data.
Save on the USB drive.
Escape from this menu.

▪ Back to the main menu.
▪ Get access to the following software and hardware configuration status.
Note: Editable screens have following buttons:
▪ Confirmation button.
▪ Cancel button.
▪ Selection in tables.
Note: Table screen have following buttons:
Move to the top of the table.
Move up in the table step by step.
Move down in the table step by step.

Move to the bottom of the table.
move to the bottom of the table
Move to the left of the table.
Move to the left step by step.
Move to the right of the table.
Move to the right step by step.
Uncheck to unselect.
Check to select.

3.3.4 Reagent setting
Select , the following screen is

displayed.
1. Select and by using Barcode Scanner fill in the fields Lot, Expiry, Capacity, SERIAL and
CODE. Information is provided on the label of diluent container in form of two barcodes.
Once fields completed, select to save

modification, the following window is displayed.
Select to save changes or to cancel.
2. Select and by using Barcode Scanner fill in the fields: Lot, Expiry, Capacity, SERIAL and
CODE. Information is provided on the label of lyse container in form of two barcodes.
Once fields completed, select to save

modification, the following window is displayed.

3. Select and by using Barcode Scanner fill in the fields: Lot, Expiry, Capacity, SERIAL and
CODE. Information is provided on the label of cleaner container in form of two barcodes.
Once fields completed, select to save modification,

the following window is displayed.
4. Select to enter in the dedicated waste management menu.
By leaving the WASTE OPEN DRAIN option unselected , the waste capacity is required. With
this configuration, the waste capacity is managed and is required to be reset when the waste level is
ALMOST FULL OR FULL.
NOTE: It is recommended to use a waste container at least from the same capacity than the
diluent one.
To Reset the waste volume:
Select on WASTE menu to reset the waste current level, the following window is displayed.
Select to confirm, then waste current level is reset to 0%.

Select in reagent screen to validate the modifications, the following window is displayed.
Selecting the WASTE OPEN DRAIN option removes the WASTE CAPACITY from the user interface.
In this case, the waste level is not managed. This

configuration is required when the instrument is
connected to centralized waste management system.
Select to perform a complete prime of all reagents.
Be sure that all reagents and waste tubes are properly connected before starting.
Perform a calibration, section 7 and a quality control, section 6, then the
MYTHIC 60 WILL BE READY TO OPERATE.
When the cycle LED turns red, no cycle can be performed before it turns back
green.
The reset of the Cycle Counter is only allowed to the Technician.
3.3.5 STARTUP
Startup cycle is dedicated to daily determine the background (blank) values of measured parameters.
It must be launched everyday before QC and then before patient’s analysis.
Press on .
The front cycle LED turns red , meaning no cycle can be launched
before it turns green.
Instrument will proceed first with counting chambers rinsing then,
1 to 3 blank cycles to control the background values.

NOTE: The background values do not to exceed the following levels:
WBC: 0.2
RBC: 0.02
HGB: 0.2
PLT: 10
DIF#: 100 (number of pulses within the DIF Plot)
If any level from any parameter is higher than expected value, the system warns the user with an alarm
message “STARTUP FAILED”, it is suggested in this case to perform a new start up.
NOTE: If the user chooses to run patient blood after a startup failed, all results will be displayed
and printed with the indication “Startup failed”.
Once the startup is performed, the following screen is display

in the RESULTS screen.
Only WBC, RBC, HGB, PLT and DIF# are displayed.
Chapter 4. STATS
4.1 Introduction
STATS menu is dedicated for Calibration, Quality Control and repeatability.
To control the stability of the instrument before running patient samples, it is mandatory to run QC
bloods from different levels at the beginning of the working day. In case of result out of range on QC
bloods, it is recommended to perform a calibration, then run QC blood again.
Concerning Quality Control Blood, it is strongly recommended to respect strictly the

manufacturer instructions in matter of storage temperature, agitation and caution
to use. Read carefully the information provided by supplier.
4.2 QC
QC menu is dedicated to Quality Control of the instrument. MYTHIC 60 can store in internal memory,
up to 100 results (results and histograms) per lot for 12 different lots. Results of each QC lot and level
can be viewed in tables and as Levey-Jennings graph.
It is recommended to run QC every day before patient’s analysis. If it is not done,

the message “QC not done” will appear in Flags field of the result on screen as well
as on the printed report.
If the last QC result is out of the lot limits, the message “QC FAILED” is set to
every analysis until a correct message “QC is done“ - MYTHIC 60 is configured in
this way.
Press STATS on the main menu, then QC, the following screen is displayed.
This screen is the table of the entire existing QC runs already recorded in the instrument.
Available in this screen:
Select the QC lot number(s), then the

action.
Concerning the QC table of the existing QC :

• The last active lot is labeled with a dark dot on the left of lot identification.
• To choose another lot, press on the related field.
• The button CHANGE allows the modification or the creation of a new item.
• The button RESULTS allows to view result table and to perform quality control analysis.
4.2.1 Change
This option allows the user: To modify data of an existing QC after selection in QC table.
To create a new item of QC after selection of a free field in QC table.
In case of modification of an existing QC, all recorded results linked with this
modified control lot number will be erased.
 Enter the QC data:

• Lot number,
• Level,
• Expiration date,
• Target values,
• Limits.

1
2 Available in this screen:
3
4
Alpha-Numeric touch screen

keyboard
Using Alpha-Numeric touch screen keyboard:
1
Enter the QC Lot number.
2
Select the QC Level among the options L (low), N (normal) or H (high).
3 Enter the QC expiration date.
4 Enter target values and limits for all parameters.
Use accessing to other parameters down in the list.
Select to confirm or to cancel modifications.
In case of validation concerning

modifications of an existing QC
Warning window is displayed.
Option allows importing QC data from usb drive instead of using touch screen keyboard.
4.2.2 Load
How to proceed to import QC from usb drive:
1. U-drive must be formatted in FAT 32.

2. Under the root, create the directory MYTHIC 60. MY
3. Under the directory MYTHIC 60, create a THI
directory QC. C
4. Under the directory QC, place the QC files. 60
Units format must be specified in order to the system to know which unit is used
Unit;1 stands for US units.
Parameters must be specified in US units ONLY.

QC LOT must be the LOT NUMBER followed by the LEVEL as shown below in an example:
QC_LOW QC_NORMAL QC_HIGH
4.2.3 Results
This screen is dedicated to:
• See results of a QC after selection in QC table.
• Run a QC analysis, after selection in QC table.

How to run with QC.
1. Select in QC table, the needle moves down in sampling position.

2. Place the control blood in sampling position.
3. Press on start cycle trigger, front LED flickers alternatively red to green, when it becomes red
only, the tube can be removed.
 Results are displayed in line in the table after run.
 Displayed down on the screen, automatic statistical calculations are implemented also
run after run.
NOTE: concerns only the selected results ( ) in the table.
 and allow access to other parameters results.

 The column allows selecting or unselecting result(s) in the table. Automatic
statistical calculations will be implemented accordingly.
4.2.4 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 parameter name is the result of the QC run where the cursor is located.

Target Cursor
• High limit
• Result
• Low limit
 The key enable displaying following pages giving access to all parameters view.
 The keys and enable displaying first or last page directly.
 The keys and enable to move the cursor from QC result to another one.
 The keys and enable to move the cursor to the first QC result or the last one directly.
 RESULT shows the number of results for the selected QC.

 DATE/HOUR gives data about date and time of the related displayed result.
Date & time for selected run number 10.
4.2.5 Details
This screen allows to see the detailed result of a selected QC in RESULTS table.
Note: To select a QC results in RESULTS table, first press on the QC line at the place you
want to see the details, then select DETAIL.
QC lines selected.

move to the first result move to the last result
move to the previous result move to the next result
4.3 Calibration
To reach Calibration screen, press in main menu, then press .

The following screen is displayed, providing information concerning the last calibration done:
• Lot number.
• Expiry.
• Date.
• Operator name.
• Target and ranges values for calibrated parameters.
• Current coefficients from last calibration.
4.3.1 Change
To enter new data or to modify existing ones, press , the following screen is displayed.

In case of modification of an existing calibration data, all linked recorded results
will be erased.
Using the Alpha-Numeric touch screen keyboard or external keyboard:
1
Enter the Calibrator Lot number.
2
Enter the Calibrator expiration date.
3
Enter targets and limits values for all parameters.
4
Select to confirm modification, the following window is displayed.
In case of validation concerning modifications of an existing

calibration Question window is displayed.
Press to validate new calibrator data record or to exit without saving.
4.3.2 Results
This screen is dedicated to:
• See results of last Calibration.
• Run a new Calibration.

How to run with Calibration.
1. Select , following screen is displayed and sampling needle go down in sampling position.
1. Place the tube of calibrator in the sampling position.

2. Press on start cycle trigger, front LED flickers alternatively red to green, when it becomes red
only, the tube can be removed.
3. Repeat the same operation at least three times (maximum 12).
NOTE: At least three consecutive runs are mandatory to validate the Calibration.

 Results are displayed in line in the table after run.
 Displayed down in the screen, automatic statistical calculations are implemented also
after run.
 The column allows selecting or unselecting a result(s) in the table. Automatic

statistical calculations will be implemented accordingly.
NOTE: fields are calculated functions of the selected results ( ) in the table.
In the field below: N is the selected number of results, LOT and EXPIRY information from calibrator
used.
N= 3
LOT PUUS1116
EXPIRY 05/01/2017
Concerning Calibrator Blood, it is strongly recommended to respect strictly the

manufacturer instructions in matter of storage temperature, agitation and caution
to use. Read carefully the supplier information provided with.
The calibration blood must be used before its expiry date, be mixed and stored in
accordance with the instructions of use recommended by the manufacturer.
4. To calibrate press , the following window is displayed.

NOTE: If necessary, uncheck parameter(s) you do not want to calibrate.
5. Press to validate new calibration, following window is displayed.
7 Press to validate.
6. Select to exit without saving.
7. Press on to restart the calibration, the following window is displayed.
Select to cancel the previous calibration data or to exit

without saving.
NOTE: To print the calibration report, press TOOLS then .
Example of calibration report Print out:

4.3.3 Load
To load calibrator data from Udrive, press on , the following screen is displayed.
How to proceed to import Calibration data from Udrive.
1. Under the directory MYTHIC 60, previously created for QC, create the directory Cali.
2. Under the directory Cali, place the Calibration file.
Units format must be specified in order for the system to know which unit is used
Unit;1 stands for US units.
Parameters must be specified in US units ONLY.
Mythic 60

4.4 Repeatability
From main menu, press , then , the following screen is displayed.

This screen allows carrying out a test of repeatability on all parameters.
How to run with Repeatability.
1. Place the sample tube in sampling position and press the start cycle trigger.
2. The cycle LED flickers alternatively red to green, when it becomes red only the tube can be removed.
3. Repeat the operation as desired (maximum 50 runs).
4. Statistical calculations are automatically carried out with each run.
5. The column # allows to validate or to unselect a result.
6. The button allows deleting the unselected result(s).

Chapter 5 RUN SAMPLE
5.1 Introduction
Preparations before analysis.
The human venous blood sample must be collected in an EDTA K2 or K3 (Ethylene Diamine Tetracetic
Acid, two or tri potassic) tube in sufficient quantity. K3 is recommended. Time between blood collection
and measurement on the Mythic 60 should not exceed 24 hours for optimal results. If the blood was
cooled, please remove it from cooler and keep it at room temperature for minimum 20 minutes in
vertical position.
Sample must be correctly homogenized before analysis. It is recommended to use a rotary agitator,
turning between 20 to 30 turns / minute, for 10 minutes.
The insufficient blood volume for the quantity of anticoagulant or a bad mixing
may involve an erroneous result.
If the room temperature moves more than 10°C during the working day,
MYTHIC 60 must be calibrated again.
It is recommended (or mandatory per the legislation) to carry out a Quality

Control (QC) and possibly a calibration at the beginning of every working day.

5.2 Run Sample
5.2.1 Run Sample – Sample Information & Sampling/Analysis Mode
1. From the main menu, press on .
2. The needle goes down in sampling position and the following screen is displayed.
3. Press NEXT SAMPLE, the following screen is displayed.
4. NAME field, to enter Patient Name (20 characters max.).
5. PID field, to enter Patient Identification (16 characters max.).
6. SID field, to enter Sample identification (16 characters max.).
7. Birth Date field, to select patient’s data.
Select successively fields day, month, year and ajust with arrows.
Note: It is not possible to enter a date <1900, future or not realistic date.
8. Doctor field, to enter Doctor ID.

9. Comments field, to add comments if needed.
10. Mode field, to select blood type among DIF WB for DIF whole blood mode, DIF PD for DIF
pre-diluted mode, CBC WB for CBC Whole Blood or CBC PD for CBC pre-diluted mode.
11. Gender field, to select gender among F for female, M for male or U for unknown.
12. To valid the entry and return to the previous screen, press , following screen is displayed.
13. To return to the previous screen without validation, press .
14. The mode is also accessible from the mode button localized on the RUN SAMPLE screen.

Clicking on the mode button, allow to display the following prompt:
The user can then select among the four available modes.
Once the mode is selected, the button label is updated with the following name: DIF WB, DIF PD,
CBC WB or CBC PD.
Pre-dilution:
If the Pre-diluted mode is selected, the following prompt is displayed and the DIL DISPENSE
button is displayed on the RUN SAMPLE screen.
Clicking on the DIL DISPENSE button allows dispending 300µL to prepare the dilution.

5.2.2 How to Run With Patient Blood Analysis
Wear rubber gloves and wash hands with a disinfectant after completion of work.
1. If the needle is not down in sampling position, press on start cycle trigger and needle will go
down in sampling position.
Start cycle trigger.
2. Place the tube in order to introduce the needle two-thirds inside the blood volume and press
on start cycle trigger.
two-thirds
of the Blood volume
needle inside
NOTES:
• Front LED blinks red, meaning that tube cannot be removed.

• Tube can be removed only when the needle goes up and after front red LED stops blink
continuously.
• A beep can be heard when the sampling has been completed.
• New cycle can be started only when LED turns green again .
• As soon as the cycle is started, the SID is incremented automatically, meaning that
MYTHIC 60 is available for the next sample identification.
• Display, sending and printing of the result start few seconds before the end of the analysis
cycle.
• No need to wait till the end of the printing to start the next analysis.
3. Result is displayed on the screen.
4. In the lower part of screen patient data field is located.
5.2.3 Understand Results
On the left side there is the field of patient’s identification data.

In the lower part of the screen there is Flag box field where the potential System or
Morphological flags are displayed if any.
Note: If you press anywhere on System Alerts field, an enlarged window is displayed. In this
window, the messages are displayed in expanded version. For Example, “QC Not Done” will be
displayed as “QC Not Done During The Day”.
Note: If you press anywhere on DIF Plot or histograms fields, a zoom of the one selected is
displayed.

Each parameter value is accompanied with specific information per the automation characteristics.
Thus, additional information can be displayed on the right side of the result.
• Over range on linearity high limit: Result is displayed such as “XXXX +”.
• Over range on reportable limit: Result is displayed such as “++++”.
• Over range on extreme limits (user controlled): Result is displayed such as “XXXX L/H”.
• Over range on normal limits (user controlled): Result is displayed such as “XXXX l/h”.
• Rejected result: Result is displayed such as “XXXX *”.
• Suspicious result is displayed such as “XXXX!”.
• Invalid result is displayed such as “----“.
Example of patient result printout:

Chapter 6 TECHNOLOGY
6.1 Detection Principle WBC, RBC, PLT Counting
The counting as well as the discrimination of the cellular elements of the blood sample is based on The
Coulter Principle.
This technics is based on the modification of the impedance of a calibrated aperture soaking in an
electrolyte and going through a constant current delivered by two electrodes located on both sides of
the aperture.
A vacuum applied on a side of the aperture allows the cells passage. Cells oppose their physical volume
to the current passage. A voltage impulse is registered at the electrodes terminal. The height of this
impulse is proportional to the cell volume.

6.2 Five-part diff measurement
The principle of this technology is based on the introduction of the sample solution flow in the flow cell
with low pressure and the introduction of the diluent sheath with a high pressure. Thus, the diluent
sheath drives the sample flow straight across the cuvette through the detection area.
The main advantages are:
 High level of reliability of the optical adjustment.

 Only two measurement axes for five parameters.
 High resolution matrix.
 Low level of contamination between two measurements.
 Low reagents consumption.
Hydraulic connection
Optical Flow Cell
Flow Cell holder
Nozzle holder
Hydraulic connection
White blood cells

Absorbance detection
Transmitted Incident Light

LED Light flow Flow
Diffraction
detection
Absorbance
Eosinophils Neutrophils
Lymphocytes Monocytes
Diffraction
Basophils

6.3 Hemoglobin Measurement
The hemoglobin measurement is done directly in the WBC chamber, by spectrophotometry ( = 545
nm).
Hemoglobin is detected by formation of oxyhemoglobin.
HGB blank check is performed at each STARTUP cycle.
HGB blank measurement is done also at the beginning of each analysis cycle.
By comparison of the two values, it is possible to follow potential evolution of the blank value in order
to warn the user if necessary.
6.4 Leukocyte Analysis
The White Blood Cell Total Count is obtained by Impedance metric in the WBC counting chamber; the
other ten parameters are obtained by flow cytometry measurement.
Parameter Associated Pathologies

Leukocytosis when WBC>WBC h
WBC White Blood Cells Total count.
Leucopenia when WBC<WBC l
LYM% Lymphocytes expressed in percentage. Lymphocytosis when LYM # > LYM # h
LYM# Lymphocytes expressed in absolute value. Lymphopenia when LYM # < LYM # l
MON% Monocytes cells expressed in percentage.
Monocytosis when MON > MON h (% & #)
MON# Monocytes cells expressed in absolute value.
Neutrophilia when NEU % > GRA % h
NEU% Neutrophils expressed in percentage.
Neutropenia when NEU % < GRA % l
Neutrophilia when GRA # > GRA # h
NEU# Neutrophils expressed in absolute value.
Neutropenia when GRA # < GRA # l
EOS% Eosinophils expressed in percentage.
Eosinophila when EOS > EOS h (% & #)
EOS# Eosinophils cells expressed in absolute value.
BAS% Basophils expressed in percentage.
Basophilia when BAS > BAS h (%&/or #)
BAS# Basophils expressed in absolute value.
IMM% Immature cells expressed in percentage.
Immature Cells when IMM> IMM h (%&/or #)
IMM# Immature cells expressed in absolute value.
ALY% Atypical lymph. cells expressed in percentage. Atypical Lymphocytes when ALY> ALY
ALY# Atypical lymph. expressed in absolute value. h(%&/or #)

WBC Total Count calculation is based on the pulses distribution curve after the action of the lytic
reagent.
The lyse reagent destroys the RBC and their stromas and acts on the cell cytoplasmic walls for better
discrimination into the optic measurement.
L1 L5
 WBC histogram is displayed after pressing on DIF Plot on the result screen.
 L1 and L5 thresholds are displayed on curve in full vertical blue color line.
NOTE: First peak on the left side of the histogram represents the lymphocytes cells, the other
one located on the right side represents all the others WBC populations.
WBC 5 differential absolute values and percentages are obtained by optic measurement.
The measured pulses on the two optical channels are displayed on DIF Plot ALL (Y axis) and
FSC (X axis).
Each dot on the DIF Plot represents the height in ALL and FSC of each pulse.
Lymphocytes (as well as atypical lymphocytes)

population is colored in PINK.
Monocytes population is colored in BLUE.
Neutrophils population is colored in GREEN.
Eosinophils population is colored in YELLOW.
Basophils population is colored in ORANGE.
Immature cells population is colored in RED.

6.5 Erythrocyte Analysis
The erythrocyte analysis is done by impedance metric in RBC counting chamber. Eight parameters are
obtained:
Parameters Associated Pathologies

RBC Red Blood Cells Erythrocytosis RBC > RBC h
HGB Hemoglobin Anemia HGB < HGB b
HCT Hematocrit
MCV Mean Corpuscular Volume Microcytosis VMC < VMC b
Macrocytosis VMC > VMC h
MCH Mean Corpuscular Hemoglobin
MCHC Mean Corpuscular Hemoglobin Concentration Hypochromia MCHC < MCHC b
Cold Agglutinin MCHC > MCHC h
RDW-CV Red blood cells Distribution Width (CV) Anisocytosis RDW-CV > RDW-CV h
RDW-SD Red blood cells Distribution Width (SD) Anisocytosis RDW-SD > RDW-SD h
RBC calculation is based on the pulses distribution curve.
R1 R2
 RBC histogram is displayed on result screen.

 R1 and R2 thresholds are displayed on curve in full vertical blue color line.
 Hematocrit (HCT) is measured by integration of the volume of the red blood cells which flow in
the RBC counting chamber aperture.
 Mean Corpuscular Volume (MCV) is obtained by calculation, following the formula:
𝐇𝐂𝐓 𝐱 𝟏𝟎
𝐌𝐂𝐕 =
𝐑𝐁𝐂
 The RBC distribution curve analysis allows the measurement of RDW-CV which is an expression

of the standard deviation compared to MCV. This parameter evaluates the RBC anisocytosis.
𝐤 𝐱 𝐒𝐃
𝐑𝐃𝐖 =
𝐌𝐂𝐕
 Mean Corpuscular Hemoglobin (MCH) calculation is obtained from HGB and RBC by the following
formula:
𝐇𝐆𝐁 𝐱 𝟏𝟎
𝐌𝐂𝐇 =
𝐑𝐁𝐂
 Mean Corpuscular Hemoglobin Concentration (MCHC) is calculated from HGB and HCT by the
formula below:
𝐇𝐆𝐁 𝐱 𝟏𝟎𝟎
𝐌𝐂𝐇𝐂 =
𝐇𝐂𝐓
 RDW-SD is an actual measure of size. It is derived by finding the width at the 20% height of
the distribution histogram.
 RDW-CV is determined by taking the standard deviation of RDW-SD and the mean corpuscular
volume (MCV) number.

6.6 Platelet Analysis
Platelet analysis is made by impedance metric in the RBC counting chamber.

Five parameters are obtained:
Parameters Pathologies
PLT Platelets Thrombopenia PLT<PLT b
Thrombocytosis PLT>PLT h
MPV Mean Platelet Volume Giant platelets MPV> MPV h
Small platelets MPV<MPV l
PCT Thrombocrit
PDW Platelet Distribution Width
PLCR Platelet Large Cell Ratio
PLT calculation is based on the pulses distribution curve.
CP1 CP2
P CP3
 PLT histogram is displayed on the result screen.

 Only P threshold is displayed in full vertical line using Blue as standard color.
 Thrombocrit (PCT) is made from PLT and MPV by formula below:
𝐏𝐋𝐓 𝐱 𝐌𝐏𝐕
𝐏𝐂𝐓 =
𝟏𝟎𝟎𝟎𝟎

 Platelet Large Cell Ratio (PLCR) indicates the percentage of large platelets with a volume >12 fL.
Aside from the two flexible discriminators which delimit the volume distribution curve, there
is additionally a fixed discriminator at 12 fL (marked in red on below picture). The PLCR is the
percentage of cells higher than 12fL regarding the whole platelets count.
6.7 Alarms
MYTHIC 60 manages different alarms. These alarms allow user to be alerted if there is a mistake
which can affect the quality of the results. These alarms appear on screen at the right of the result.
In presence of one or more alarms, it is recommended to check the result by a

conventional measure or on blood smear.
NOTE: Most of these alarms can be adjusted by the user.
6.7.1 General Flags

Each parameter value is accompanied with specific information per the automation characteristics.
XXXX+: Over range on linearity high limit.

XXXX!: Suspicious result. Occurs when a morphological alarm has been triggered (please see chapters
below) or when an associated parameter might be suspected (For instance, if WBC if flagged with +,
LYM, MON, NEU, EOS and BAS will be flagged with +).
++++ : Higher than the reportable limits. WBC, RBC, PLT, HCT, HGB.
----: Invalid result.
XXXX*: Rejected result.
h: Results higher than normal value.
L: Results lower than normal value.
H: Results higher than panic value.
L: Results lower than panic value.
NOTE: Whenever one of the following symbol is triggered: *, -, +, ++++, display tagged result
in bold (flag included).
Whenever one of the following flag is triggered: L, l, h, H, display tagged result normally and
flagged in bold.
Whenever “!” is triggered display afferent result in italic (flag included).
Change color of all flagged result to a specific color in accordance to the UI specifications (flag
included):
• Orange (l, h) is used as standard color.

• Red (L, H) is used as standard color.
When result is flagged with: *, +, ++++,!, the parameter printout on table view is the parameter
value followed or replaced (++++) by the appropriate symbol.
When result is flagged with L,l, h or H, the parameter printout on table view is in reverse video
only.
6.7.2 Leukocytes Flags

Extraction of distribution curve in height of pulses (after initial pulse width based cut-off).
L1 L5
Two editable thresholds L1, L5 enable to discriminate the resistive count flags.
MORPHOLOGICAL ALARMS
On Curve
Alarm Short
Trigger Condition Alarm Flags enlarged
version
Review on Smear:
Determination of the population defined from channel
Small lymphocytes,
CL1 to CL1-2.
Probable Incomplete,
The alarm is raised if this population is higher than L1
Erytrolysis,
an absolute limit AND a percentage of the
Platelet Aggregates,
lymphocytes population.
Erythroblats.
Determination of the population defined by CL5
threshold and curve ending.
Review on Smear:
The alarm is raised if this population is higher than L5
Immature Cells.
an absolute limit AND a percentage of the WBC
population.

The measured pulses on the two optical channels are displayed on DIF Plot ALL (Y axis) Vs
FSC (X axis).
Definition of height zones enable to discriminate optic count flags.
On DIF Plot
Trigger Condition Alarm Short version Alarm Flags enlarged
Presence of cells in the zone Review on Smear:
regarding the total number of N1 Debris or Small Cells,
leukocytes in the DIF Plot. Platelet Aggregates.
Review on Smear:
Presence of cells in the zone Probable Incomplete,
regarding the number of N2 Erytrolysis,
lymphocytes. Platelet Aggregates,
Erythroblasts.
Review the DIF.
Presence of Immature Cells (from
IMM Review on Smear:
the mono or polynucleated cells line).
Immature Cells.
Review the DIF.
Presence of atypical lymphocytes. ALY Review on Smear:
Atypical Lymphocytes.
Review the DIF.
Presence of atypical lymphocytes or
RL Review on Smear:
basophiles.
Right Lymphocytes.
Presence of basophiles, small
Review the DIF.
neutrophils (without granulations or HL
High Lymphocytes.
few segmented), band cells.
Presence of small neutrophils
(without granulations or few Review the DIF.
NL
segmented), band cells or hyper Low Neutrophils.
basophil monocytes.

Presence of giant neutrophils, hyper
segmented neutrophils, eosinophils Review the DIF.
NH
with few granulations or damaged High Neutrophils.
eosinophils.
6.7.3 Erythrocyte and HGB Flags

Extraction of distribution curve in height of pulses (after initial pulse width based cut-off).
Two editable thresholds R1 and R2 enable to discriminate between microcytes, normocytes and
macrocytes. CR1 CR2
100%
68.26% of total
distribution area
RDW
RDW-SD
20%
MCV
 MCV is measured on the whole RBC acquisition.

 HCT parameter is calculated from MCV and RBC parameters.
 MCHC parameter is calculated from HGB and HCT parameters.
 MCH parameter is calculated from HGB and RBC parameters.
 RDW parameter is calculated on curve distribution (defined as the CV of 68.26% of total
distribution area).
 RDW-SD parameter is calculated on curve distribution (defined as curve width at 20% of
peak).
On The Curve
Determination of the population defined from
channel 0 to CR1.
The alarm is raised if this population is higher than R1 Microcytes
an absolute limit OR a percentage of the RBC
population.
Determination of the population defined by CR2
threshold and curve ending.
The alarm is raised if this population is higher than R2 Macrocytes
an absolute limit OR a percentage of the RBC
population.

6.7.4 Platelet Flags
Extraction of distribution curve in height of pulses (after initial pulse width based cut-off), below an
editable threshold P that discriminates between PLT and RBC (sample dependent).
On The Curve
Determination of the population defined from channel 0
to CP1.The alarm is raised if this population is higher
than an absolute limit OR a percentage of the PLT P1 Platelet Debris
population.
Determination of the population defined by CP2

threshold and P.
P2 Schizocytes
The alarm is raised if this population is higher than an
absolute limit OR a percentage of the PLT population.
Determination of the population defined by CP3
threshold and over a CP3-2 width at the right of CP3.
P3 Microcytes
The alarm is raised if this population is higher than an
absolute limit AND a percentage of the PLT population.
NOTE: Only P threshold is displayed on histogram.

 MPV parameter is calculated on curve distribution (defined as curve width at 20% of peak).
 PCT parameter is calculated from PLT and MPV parameters.
 P-LCR is calculated as the percentage of platelets with a volume higher than 12fL, i.e. those
appearing between 12fL and P.
 P-LCR is significantly decreased in patients with thrombocytosis while it is increased in
thrombocytopenia. In patients with high counts, P-LCR is significantly decreased in reactive
thrombocytosis than neoplastic thrombocytosis. P-LCR is more likely higher in destructive
thrombocytopenia than hypoproliferative thrombocytopenia. P-LCR is inversely related to
platelet count and directly related to PDW and MPV.

6.7.5 System Alerts
6.7.5.1 INS-T / Instrument Temperature Out Of Range

Means that the instrument temperature is lower than 17°C or higher than 33°C and the results could
be affected.
6.7.5.2 WBC BAL / WBC Balance

Unbalanced counting between the resistive and the optical measurement on the WBC channel. This may
be explained by a clog on the WBC aperture, a clog on the WBC flow cell or that the stop cock has been
left as closed.
6.7.5.3 WBC-CL / WBC Aperture Clog

Clog detected during WBC measurement.
6.7.5.4 RBC-CL / RBC Aperture Clog

Clog detected during RBC or PLT measurement.
6.7.5.5 O-DF / Optical Default

Unstable LED light low measurement during WBC DIF measurement. This may come from bubble or
unexpected phenomenon during WBC DIF measurement.
6.7.5.6 SU-F / Startup Failed

Background limits or HGB blank are out of range.
6.7.5.7 QC Not Done / QC Not Done During The Day

While no QC are done during the day. This system alert is set to every analysis until a QC sample is
run.
6.7.5.8 QC Failed / Last Run QC Failed

The last QC result is out of the lot limits. This system alert is set to every analysis until a correct QC
is done.

6.8 Hydraulic Description
The fluidic part is located on the right side of the instrument directly accessible after opening the
fluidic door.
The fluidic part consists six elements listed below:
1. Sampling module.
2. Syringe module.
3. Syringe valve module.
4. Counting module.
5. Counting valve module.
6. Optical Bench.
1
3

6.8.1 Sampling module
This module (patented) allows the blood sampling and dispensing in counting chambers (WBC and RBC)
to perform appropriate dilutions.
It supports the needle and its rinse block assembly called rinse head.
The needle and its rinse head can be removed completely without tool.
The o-ring of the needle, located inside the rinsing head, can also be removed without tool.
The maintenance of these parts is very easy to perform, please refer to the maintenance chapter to
perform it as describes.
6.8.2 Syringe module

This module allows to perform the aspiration/dispense of the reagents, blood’s drawing, vacuum and
positive pressure.
6.8.3 Syringe valve module

This module supports the valves allowing opening or closing the reagents and waste syringes hydraulic
circuit as well as the optic hydraulic circuit.
6.8.4 Counting module

This module allows to count the WBC and RBC/PLT and to measure the HGB.
6.8.5 Optical Bench

This module allows discriminating the 5 parts diff for WBC.
6.9 Software
MYTHIC 60 software runs using the Linux operating system. The software is embedded on a Q7 CPU
board.
This board is equipped with an Intel ATOM CPU (32 bits), RAM memory and flash where software and
data are stored.
6.9.1 Graphical User Interface

Common keys present in all screens:
allows coming back to the previous screen in the menu tree.
allows to opens a contextual menu for actions linked to the current menu (save, delete, print,
sent…).
An exit button allows closing the tools window and returning to current menu.
allows coming back to the MENU display where ever you are in the arborescence.

displays of current state of the instrument:
• Instrument Model.
• Operation System version.
• Software version.
• FPGA / uBlaze versions.
• Algorithm (dynamic clustering version).
• Cycles modules.
• Fluidic module: N/A.
• Instrument’s Serial Number.
• User - Login level.
• IP address.
6.9.2 Windows
Mythic 60 displays few types of window to communicate with the operator in case of needs.
1. Confirmation message.
2. Information message.

Chapter 7 SPECIFICATIONS
7.1 Analytical Specifications
7.1.1 Linearity
Linearity of WBC, RBC, HGB, HCT and PLT will be verified using linearity kits.
Measuring Limits (the Operating

Measurand Units*
Range larger) Range
WBC 103/µL 0.2 – 100 ± 0.4 or ± 4% 0 - 150
0.02 – 8.0 ± 0.05 or ± 3%

RBC 106/µL 0 - 15
8.0 – 15 ± 0.10 or ± 4%
HGB g/dL 0.2 – 24 ± 0.2 or ± 2% 0-25
HCT % 5 – 70 ± 2 or ± 3% 0-80
MCV fL 50-150 ±2.5 or ±3.0% 50 - 150
PLT 103/µL 10 – 2000 ± 10 or ± 10% 0 - 4000
RDW-CV % 10 – 40 ± 1.5 or ± 10% 0 – 70
RDW-SD fL 15 – 150 ± 6.5 or ± 10% 0 – 220
MPV fL 5 – 25 ± 1 or ± 10% 0 – 25
MCH pg N/A N/A 0 – 99.9
MCHC g/dL N/A N/A 0 – 99.9
PCT % N/A N/A 0 – 9.999
PDW % N/A N/A 0 – 99.9
PLCR % N/A N/A 0 - 100
LYM, MONO, NEU,

EOS, BASO, ALY, 103/µL 0-100 N/A 0 - 150
IMM #
LYM, MONO, NEU,

EOS, BASO, ALY, 103/µL 0-100 N/A 0 - 100
IMM %

7.1.2 Background
Maximum background counts during STARTUP cycle.
Measurand* Background Concentration Limits
WBC / DIFF < 0.2 103/µL
RBC < 0.02 106/µL
HGB < 0.2 g/dL
PLT < 10 103/µL
*Results are expressed in Standard (US) units.
7.1.3 Precision
Short term (within run) imprecision will be tested by assaying the same normal whole blood (collected
in K2EDTA) specimen consecutively 20 times.
Measurand Repeatability Limits

Ranges Tested
(Units*) Whole blood (%CV)
WBC (103/µL) >6.0 < 2.5
RBC (106/µL) >3.5 < 2.0
HGB (g/dL) >11 < 1.5
MCV (fL) >80 < 1.0
HCT (%) >35 < 2.0
RDW-CV (%) >12 < 4.0
RDW-SD (%) >40 < 4.0
PLT(103/µL) >200 <5.0
MPV (fL) >8 <3.0
Lymphocyte (%) >15 < 5.0
Monocyte (%) >5.0 < 10
Neutrophil (%) >40 < 3.0
Eosinophil (%) >5.0 < 10
Basophil (%) >1.0 < 40

7.1.4 Carry-Over
The following table shows carryover percent for WBC, RBC, HGB and PLT. Carryover will be determined
by running linearity kit specimens with high target values of WBC, RBC, HGB and PLT. Each specimen
will be run in triplicate followed by three blank runs. Carryover is calculated and expressed as
a percentage using the following formula:
Measurand Target Values % Carryover

(95% Confidence
(units*) Low Target Values High Target Value Limit)
WBC / DIFF
> 0 < 0.2 >15 <1%
(103/µL)
RBC (106/µL) > 0 < 0.02 >6 <1%
HGB (g/dL) > 0 < 0.2 >20 <1%
PLT (103/µL) > 0 < 10 >300 <2%

7.1.5 Correlation
Specimens from normal blood donors and specimens from patients identified with normal and abnormal
hematology results will be run in duplicate on test systems and comparative Systems using same
measurement technique.
All results have no alarm or flag.
Measurand (Units*) Range Tested r-value Comparability
0.2-100 ≥0.95 N/A
WBC (103/µL) 0.2 to <2.00 N/A ±10%
2.00 to 100 N/A ±5%
RBC (106/µL) 0.02 – 7.0 ≥0.95 ±2.5%
HGB (g/dL) 0.2 -22 ≥0.95 ±2.5%
HCT (%) 15 – 60 ≥0.90 N/A
MCV (fL) 55-120 ≥0.90 ±3.0%
RDW-CV (%) >12 ≥0.60 N/A
RDW-SD (%) ≥ 35 ≥0.60 N/A
PLT (103/µL) 10-1500 ≥0.95 N/A
MPV (fL) >7 ≥0.90 N/A
Lymphocyte (%) >15 ≥0.95 N/A
Monocyte (%) >5.0 ≥0.95 N/A
Neutrophil (%) >40 ≥0.95 N/A
Eosinophil (%) >5.0 ≥0.90 N/A
Basophil (%) >1.0 ≥0.15 N/A
*Results are expressed in Standard (US) units

7.2 Units
MYTHIC 60 presents the hematology results in a multiple units.
US
Parameters SI SI MOD JAPANESE
(Standard)
WBC XXX.X XXX.X XXX.X XXXX.

103/µL 109/L 109/L 102/µL
LYM, MONO, NEU, EOS, BASO, ALY, IMM # XXX.X XXX.X XXX.X XXX
103/µL 109/L 109/L 102/µL
LYM, MONO, NEU, EOS, BASO, ALY, IMM % XX.X XX.X XX.X XX.X
% % % %
RBC XX.XX XX.XX XX.XX XXXX

106/µL 1012/L 1012/L 104/µL
HGB XX.X XXX XX.XX XX.X

g/dL g/L mmol/L g/dL
HCT XX.X X.XXX X.XXX XX.X

% L/L L/L %
MCV XXX.X XXX.X XXX.X XXX.X

fL fL fL fL
MCH XX.X XX.X X.XX XX.X

pg pg fmol pg
MCHC XX.X XXX XX.XX XX.X

g/dL g/L mmol/L g/dL
RDW CV XX.X XX.X XX.X XX.X

% % % %
RDW SD XXX,X XXX,X XXX,X XXX,X

fl fl fl fl
PLT XXXX XXXX XXXX

XXX.X 104/µL
103/µL 109/L 109/L
MPV XX.X XX.X XX.X XX.X

fL fL fL fL
PCT X.XXX X.XXX X.XXX X.XXX

% cL/L cL/L %
PDW XX.X XX.X XX.X XX.X

% % % %
P-LCR XX.X XX.X XX.X XX.X

% % % %
 L: liter.
 µ: micro (10-6).
 g: gram.
 dl: deciliter.
 f : femto (10-15).
 mmol : millimole (10-3 mole).
 mol: mole.
 SI MOD: SI modified (mole instead of g).
 JAPANESE: commonly used in Japan.

7.3 Reagent consumption
Software V0.7.3 Type DILUENT LYSE (mL) CLEANER

(mL) (mL)
WB CBC Analysis Analysis 15.44 0.92 0.48
WB DIF Analysis Analysis 17.71 1.00 0.51
PD CBC Analysis Analysis 15.19 0.92 0.48
PD DIF Analysis Analysis 17.46 1.02 0.49
Dil Dispense Analysis 0.30 0.00 0.00
Fluidics Control Daily Use 15.04 0.11 0.29
Pre-Startup Daily Use 63.89 2.71 1.48
Startup Daily Use Pre-Startup + from 1 to 3 WB DIF
cycles
Shutdown Daily Use 0.00 0.47 32.24
Automatic Rinse Daily Use 17.71 1.19 0.55
Bleach Clean 61.62 1.27 9.40
Back flush Clean 11.72 0.10 0.71
Backflush Optic Clean 5.51 0.19 0.00
Cleaning Clean 17.08 0.42 15.02
Prime ALL Prime 40.15 7.13 5.25
Prime Diluent Prime 39.13 0.42 0.00
Prime Lyse Prime 5.76 6.84 0.00
Prime Cleaner Prime 0.00 0.00 5.05
Rinse Chambers Rinse 11.70 0.10 0.00
Rinse WBC BAL Rinse 11.62 0.89 0.00
Prime_Wait Rinse 16.19 1.09 0.53
Latex RBC Adjust. 7.55 0.00 0.39
Latex WBC Adjust. 13.16 1.01 0.38
Adjust OB Adjust. 17.80 1.02 0.00
Adjust OB LED Adjust. 5.90 0.05 0.00
Check OB / ADJ Adjust. 17.71 1.0 0.51
WBC /
CHECK WBC
Adjust HB LED Adjust. 11.70 0.10 0.00
Drain For Pack Up Drain 61.69 1.27 9.40
Drain Flow Cell Drain 5.42 0.10 0.00

7.4 Physical Specifications
General:
Ambient temperature: from 18 to 32°C.
Relative Humidity: maximum 80% at 32°C.
Storage temperature: -10 to 50°C.
If MYTHIC 60 has been stored at a temperature less than 10°C, it must stay at
room temperature during 24 hours before switching it on.
If the room temperature moves more than 10°C during the working day, MYTHIC 60
must be calibrated.
7.4.1 Instrument Specifications

The physical specifications of the instrument:
- Dimensions: height: 405 mm (approx.) * width: 270 mm (approx.) * depth: 430 mm (approx.).
- Weight: 12kg (approx.).
- Power supply input: 100-240VAC 50-60Hz.
- Power supply output: 24V – 6.75A.
- Electric consumption: 160W
- Screen: LCD Touch-screen 8.4 inch (800*600).
- Memory capacity: 35000 Files (demographics, results and histograms).
QC: 12 lots (100 results per lot).
- Connection: 5 USB ports/ Ethernet-RJ45/ Serial LIS-SUB D9, PC connection/Serial Port.
7.4.2 Power Supply Block

Mythic 60 is equipped with an external Power Supply Block.
Dimensions:
• Height: 31 mm (approx.)
• Width: 58,5 mm (approx.)
• Depth: 132 mm (approx.)
• Weight: 0,35 kg (approx.)
• Power supply Input: 100 to 240V AC - 1,5A, 50-
60Hz

7.5 Reagents Specifications
7.5.1 Diluent for Mythic 22

ORPHEE code number: HM22-003-10.
Open shelf life: 60 days.
Application: The diluent is used to carry out the necessary dilutions for the measurement performed
by the MYTHIC 60 (see section 6).
Active components: Inorganic salts …………… <0.9 %

Other components:
Buffer.
Others components: Preservatives and metal ion chelator.
Description: Clear colorless solution with mild characteristic smell of 2-phenoxyethanol.
Storage: At temperature between 18C and 30C until the expiry date printed on the bottle label.
Precautions:
Classification according to Regulation (EC) No. 1272/2008 [CLP]/GHS: Not classified.
Adverse physicochemical, human health and environmental effects.
To our knowledge, this product does not present any particular risk, provided it is handled in
accordance with good occupational hygiene and safety practice.
Labelling: No labelling applicable.
This mixture does not contain any substances to be mentioned according to the criteria of section 3.2
of REACH annex II.
Wear a lab coat, gloves and glasses during manipulation.
First emergency care:

Inhalation: Supply fresh air. Consult doctor in case of symptoms.
Eyes: Rinse opened eye for several minutes under running water.
Skin: The product is not skin irritating.
Ingestion: In case of persistent symptoms consult doctor.
Accidental release and disposal measure:

Person related safety precautions: Wear protective equipment; keep unprotected persons away.
Environmental protection: Do not allow product to reach sewage system or water bodies.
Cleaning/collecting: Absorb with liquid-binding material (sand diatomite, acid
binders, Universal binders saw dust).
Comply with local and/or federal disposal legislation.
If any doubt, call an emergency center.

7.5.2“OnlyOne”
Open shelf life: 60 days.
Application: 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 60 (see section 6).
Active components: alkaline salts,

buffer system,
mixture of ionic (quaternary ammoniums) and non-ionic detergents,
hemoglobin chelating agent,
preservatives and leukoprotective agents.
Description: A clear, pale yellow, odourless, aqueous solution.
NOTA: This reagent is cyanide-, formaldehyde- and azide-free.
Storage: At temperature between 4C and 25C, until expiry date printed on the bottle label.
Precautions: Avoid contact with skin or eyes. Do not swallow or inhale. DO NOT REUSE THE
CONTAINER.
Labelling according to Regulation (EC) No. 1272/2008 [CLP]/GHS

May produce an allergic reaction.
OnlyOne EUH208 Reaction Mass of: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-
methyl-2H -isothiazol-3-one (3:1). <0,0015%.

After exposure by respiratory passages: supply fresh air. Consult doctor in case of symptoms.
After skin contamination: The product is not skin irritating.
After contamination of eyes: Rinse opened eye for several minutes under running water.
After swallowing: In case of persistent symptoms consult doctor.
Accidental release and disposal measure:

Cleaning/collecting: Absorb with liquid-binding material (sand diatomite, acid binders,
Universal binders saw dust).
7.5.3 Cleaner for Mythic 22
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 6).
Active Components: Proteolytic enzyme

Propylene glycol (2.5 - 10%)
Violet dye.
Description: Clear blue-violet solution with distinctive enzyme smell.
Storage: At temperature between 18C and 30C, until expiry date printed on the bottle label.
Precautions: Avoid contact with skin or eyes. Do not swallow or inhale. DO NOT REUSE THE
CONTAINER.
Labelling: No labelling applicable.

After exposure by respiratory passages: supply fresh air. Consult doctor in case of symptoms.
After skin contamination: The product is not skin irritating.
After contamination of eyes: Rinse opened eye for several minutes under running water.
After swallowing: In case of persistent symptoms consult doctor.
Accidental release and disposal measures:

Cleaning/collecting: Absorb with liquid-binding material (sand diatomite, acid binders,
universal binders, saw dust).
NEVER PUT IN A NEW REAGENT BOTTLE THE REMAINING VOLUME OF

THE PREVIOUS ALMOST EMPTY ONE.

7.5.4 Mythic 18-22 FLUSH – CLEANER
Application: Mythic 18-22 FLUSH - CLEANER is hypochlorite-based reagent. Its function is periodic
and routine cleaning of the measuring system of haematology analysers (see section 9.7.2).
Components: Sodium chloride < 10 g/l

Sodium hydroxide < 2.5 g/l
Sodium hypochlorite 70 g/l
Sodium carbonate < 5 g/l
Description: Clear, colourless solution with specific smell of chlorine.
Storage: At temperature between 2°C and 25°C, until the expiry date printed on the bottle label if
closed.
Precautions:. Product is classified as causing serious eye damage, irritating to skin and acute toxic to
aquatic life. Contact with acids liberates toxic gas. For detailed precautions please refer to relevant
Material Safety Data Sheet.

After exposure by respiratory tract: Remove exposed individual to fresh air. Call physician.
After skin contamination: Wash off with plenty of water. Take off the contaminated clothing.
After contamination of eyes: rinse out with plenty of water for at least 15 minutes with the
eyelid held wide open.
After consumption: give the individual, copious amounts of water to drink. If condition does not
improve or becomes worse, consult physician immediately.
If the sufferer feels unwell, consult a doctor/ambulance.

For detailed first aid measures please refer to relevant Material Safety Data Sheet.
It is recommended to store the bottle in the cooler once open.

7.6 Analytical Limitations
MAINTENANCE Recommendations: Please respect the maintenance procedure, calibration 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.
Each result for a new patient out of lab linearity limits or with an alarm must be
checked with a conventional method or checked with blood smear.
7.6.1 Interferences
Parameter Specimen Possible Indication of Error

Cold Agglutinin (+) ↑MCV, ↓HCT, red cell clumping on smear
Nucleated RBC (+) NRBC on smear
WBC Cryoglobulins (+)
Platelet aggregation (+) Platelet aggregates on smear
Erythroblastosis (+) Erythroblasts on smear
Cold Agglutinin (-) ↑MCV, ↓HCT, red cell clumping on smear
Severe Microcytosis (-) Elevation of WBC
RBC
Fragmented RBC (-)
Leukocytosis (>100,000/µL) (+)
Leukocytosis(>100,000/µL) (+) Elevation of WBC
HGB Lipemia (+) ↑MCHC, “milky” appearance of plasma
Abnormal Protein (+) ↑MCHC, Lysed Hgb/WBC sample turns cloudy
Cold Agglutinin (-) ↑MCV, ↓HCT, red cell clumping on smear
Leukocytosis(>100,000/µL) (+) Elevation of WBC
HCT
Abnormal Red Cell Fragility (?)
Spherocytosis (?) ↓MCV, spherocytes on smear
Pseudothrombocytopenia (-) Platelet Satellitism on smear
Platelet Aggregation (-) Platelet Aggregates on smear
PLT Increased Microcytosis (+) ↓MCV
Megalocytic Platelets (-)
(+): Instrument count is affected by an increase in the result.

(-): Instrument count is affected by a decrease in the result.
(?): Instrument count is affected by either an increase or decrease in the result which is sample
dependent.

Chapter 8 RESULTS
8.1 Introduction
MYTHIC 60 can save in internal memory up to 35 000 patient reports with results and histograms.
Here below explanations how to use results areas to search, print, send, save or erase results.
8.2 Results
Press on main menu, the following screen is displayed.
Select by ALL or by Sequences.

Select the option desired among the
available options.
All parameters are listed in first column, results of first tube of the day in second column, results of
second tube of the day in third column, etc.
The keys and allow moving from first to last page of results of the day.
The keys and allow moving from a patient file to another one.
The keys and allow moving from beginning to the end of the list of parameters.
The keys and allow moving from a parameter to another one.
The field under the table, describes NAME, PID, SID, Seq number, birth date, gender, mode, date
& time of the selected patient file.
To select a result in the table, select the corresponding column, result will appear in reverse video.

8.2.1 Date
This option allows searching a patient file(s).
1. Select the year in first column on the left.
2. Select the month in the second column.
3. Select the day in the last column on the right.
• Select to access to a general view of the selected day.

• Select to get the detailed view of the selected patient file.
Once in detailed view, use the keys moving in detailed views as the same way than
on results table view.
Select to be back in results table view.

8.2.2 Details
This option allows to display (from the results table level) the detailed view of the selected patient’s
file.
• Select to be back in results table.

Chapter 9 SERVICE
9.1 Introduction
From the main menu, select , the following screen is displayed.
No Available in this screen.
9.2 System Initialization
This option allows performing a mechanic initialization of all the modules.
NOTE: Can be used whether the instrument is switched on with the fluidic door opened and due
to that, did not performed the automatic mechanic initialization.
9.3 Logs
Log depth (EVENT+ERROR) is set to 500 entries.

When the number or EVENTS+ERRORS is higher than 500, older messages are removed from the
database.
9.3.1 Event Logs

This option allows displaying the EVENT logs of the instrument.
EVENTS are the most important actions performed or requested by the instrument’s user.
Among EVENTS lists, the user can find: WASTE IS RESET, WASTE SET AS OPEN DRAIN, PRIME
ALL CYCLE REQUESTED, STARTUP STARTS, ….
For each EVENT, the Date, Time, Operator, Event Type and Event description is recorded.

9.4 Error Log
This option allows displaying the error logs of the instrument.

Each occurrence of ERROR message window will be recorded in this file.
Among ERRORS lists, the user can find: PLEASE REPLACE DILUENT, PLEASE REPLACE DILUENT, ….
For each ERROR, the Date, Time, Operator, Event Type and Event description is recorded.

9.5 Backup & Restore
This option allows to backup and/or to restore the patients result (.csv format) the set up and
adjustments.
9.5.1 Backup
In BACKUP field check the options you want backup “Data and Setup” and/or “.csv file”, then select
.
The following window is displayed.
Connect an USB drive then press to confirm the backup.
9.5.2 Restore
In restore field, press on , the following window is displayed.
Connect an USB drive then press to confirm the restoration.

NOTE: It is recommended to perform backup regularly because in case of trouble it would be the
easiest way to restore all data in the state of the last backup save.
9.6 Settings
This menu is dedicated to set all the instrument with different options as printer, communication, limits,
flags, etc.
Select from menu, the following screen is displayed.
9.6.1 Lab Parameters

This menu allows to access to set-up options as described below.

9.6.1.1 Lab Preferences
 DIF DISPLAY FORMAT

Select the option desired for the DIFF result format among:
 Auto Increment
Check in box if you want auto-increment of SID from start number specified.
 QC
Check in the box if you want QC alert displayed and printed on patient files (QC Not Done and
QC Failed).
 RUO
Check in the box if you want to display the RUO parameters.

Note: See below the difference of display between with and without RUO parameters.

9.6.1.2 Units
This screen gives the possibility to the user to choose the units among the following list
9.6.1.2.1 US Format & Units
9.6.1.2.2 SI Format & Units

9.6.1.2.3 SI Mode Format & Units:
9.6.1.2.4 Japanese Format & Units:
 Select the model of unit you want use, then press to valid, the following window is displayed.
 Press to save changes or to cancel.
9.6.1.3 CBC Thresholds and Flags

This menu allows to modify the thresholds and flags for each CBC parameters.
No available in this screen.

Thresholds modification can affect the quality of the results or can affect the alarm
detection. We recommend to modify these values only after training.
9.6.1.4 DIF Thresholds and Flags

This menu allows to modify the thresholds and flags for each DIF parameters.
Thresholds modification can affect the quality of the results or can affect the alarm
detection. We recommend to modify these values only after training.
NOTE: In both CBC & DIF thresholds and flags menus, the button allows returning
to the original values.
9.6.1.5 References Ranges

This menu allows to modify the existing values of normal and panic limits values for all parameters.
1. allows displaying the CBC parameters.

2. allows displaying the DIF parameters.
3. allows coming back to the default values.

Following window is displayed.
Once modifications are done, press to validate or to exit

without any modification.
9.6.1.6 Calibration Factors

This menu allows modifying the calibration factors manually without to redo the complete calibration.
Once modifications are done, press to validate or to exit without any modification.
The modification of these factors without running a calibration blood could affect
the quality of the result.
If the calibration factors are manually modified, the calibration information in the
calibration screen will be flagged with “MODIFIED” and previous calibration results
are modified
If the calibration factors are manually modified, the following prompt is displayed to
inform the biologist that the calibration results will be removed.

9.6.2 Date & Time
This menu is dedicated to modify the Date /Time Settings.
 To change the date, select the field among day/month/year and change the value using the
arrows or enter it manually using the displayed numeric keyboard.
 To change the date format, press on the arrow and choose the desired format.
D for day
M for month
Y for year
 To change the time, select the minute or hour field and change the value using the arrows or
enter it manually using the displayed numeric keyboard.
 To change the time format, select the arrow and choose the desired format.
 Once modifications are done, press to validate or to exit without any modification.

9.6.3 Automatic cycles
This menu is dedicated to set the different automatic cycle.
 To enable automatic power up setting, Select Enable and choose the time and date for the automatic
power up.
 To modify the autoclean frequency, adjusted by default to be done every 25 analyses, the value can
be set from 10 to 50.
25
 If you want set an automatic shutdown, check in the option enable and enter the time chosen.
NOTE: Time is expressed in minutes and shutdown frequency can be set from 30 to 720.
Once modifications are done, press to validate or to exit without any modification.

9.6.4 Printer
This menu is dedicated to set the different possible printing options.
9.6.4.1 Printer Settings

This screen is dedicated to the printing option settings.
Select , the following screen is displayed.
 Report Headers: allows to enter the laboratory header using touch screen keyboard.
 Patient Report Options: options selected will be printed on the patient report.
 Auto Print: options selected will be automatically printed.
 Control Report Options: allows to select LMG format, percentage or absolute value for all
analysis and not only for control.
 Printer Selection: allows to select the printer and paper size.
 Once modifications are done, press to validate or to exit without any modification.
9.6.4.2 Printer Management
This screen is dedicated to the printer installation.
It must be used the first time the printer is connected to the instrument, following the instruction
below.
 Connect the printer to an USB port located at the rear of the instrument.
 Switch ON the printer.
 Select , the following screen is displayed.
No available in this
screen.
NOTE: It needs few seconds for the instrument to detect the printer as in the example below.
 Press on printer name’s field, the following window is displayed.
 Press , the following window is displayed.

 Select the field corresponding to the printer connected then press .
NOTE : As in the exemple above, if the field of the printer, connected and detected, is not
present in the list, choose pcl3 or pcl6 drivers depending from printer compatibility.
Generally: pcl3.ppd in dedicated to black & white printers and pcl6.ppd for colors printers.
 Exit the menu pressing PREVIOUS, then go back and check that the printer is well installed.
Previously not installed

 Go back to and select the type of printer in Printer Selection field.
 Press to valid, the following window is displayed.
 Press to save changes. The printer is installed.
9.6.5 Communication
This menu allows to setup the connection between MYTHIC 60 and the Host Computer of the Lab.
Select from menu, the following screen id displayed.
 Communication field allows the user to select the type of communication required.

o COMMUNICATION FORMAT, at that time only CSV format (Coma Separated Values).
NOTE: MYTHIC 60 can be connected to the host computer in two different ways:
1. Serial link (type RS232),
2. Ethernet.
3. Select NONE if no communication is required.
 allows to configure the communication data accordingly to the host computer data.
 Auto Transmit field provides the possibility to

choose the data to be transmitted. Select the
concerned options.
9.6.6 Users Management
This menu allows to add, to modify or to delete an operator and/or a biologist login information.
Select from menu, the following window is displayed.

9.6.6.1 Add
Select to add a new operator or biologist and fill in the different fields.
9.6.6.2 Change Password

Select to change the password of the selected user and fill in the different fields.
9.6.6.3 Remove
Select to delete the selected user, the following window is displayed.
Press to validate or to exit without modification.
Note: at least one Biologist id must stay in the list.
9.6.7 Software Update

This option allows to update the software when necessary.
Select , the following window is displayed.

 Connect to the front USB port, USB drive containing the software update (two files), then
press , the following screen is displayed.
 Select to valid the software update, the following screen is displayed.
NOTE: Software upgrade can take few minutes, do not remove the USB drive or power off the
instrument until the following message.

9.7 TROUBLESHOOTING
This menu gives access to different fluidic options as well as mechanical checks.
Select , the following screen is displayed:
9.7.1 Fluidics Controls
option allows performing a complete control cycle of the mechanic and the fluidic
of the instrument in case of needs. A control bar indicates the progress of the cycle.
NOTE: Control cycle allows to control mechanic, hydraulic and electric functions to completely
reinitialize the instrument when it is needed.
Example of need: In case of mechanical or hydraulic problem, immediately press on button,

MYTHIC 60 will perform an emergency stop. After having identified and fixed the problem, it is
necessary to perform a control cycle to reinitialize the instrument mechanically and hydraulically.
When control cycle is finished, the following window is displayed.

9.7.2 Flush Cleaning
allows performing a concentrate cleaning cycle using HM18-011-25 FLUSH-
CLEANER (SEE CHAPTER 7.5.4).
1. Press on button, the following window is displayed.
 Select to confirm, the following window is displayed.
2. Instrument begins to drain the counting chambers and the following window is displayed.
3. Open the fluidic door and put 4ml of Flush-Cleaner in each counting chamber. Close the fluidic
door when bleach dispense is done, then press . The system will perform fluidic actions cleaning
the mains counting module parts like apertures, counting chambers and optic flow cell.
NOTE: On each counting bath, an arrow indicates the volume of 4ml for bleach.
The bleach cycle takes 15 minutes to be completed.
It is not possible to use the instrument during that time.
9.7.3 Drain Baths
option allows draining the two counting chambers in case of needs.
The following window indicates the progress of the cycle.
NOTE: This option is principally used by Field Service Engineer in case of parts replacement
which does not require a complete instrument draining.
9.7.4 Backflush Apertures
option allows to perform a backflush onto the apertures* in case of needs.
*Backflush onto the apertures: The system push cleaner under pressure into the WBC and RBC
apertures in order to remove a potential clogging. It can be used in case of permanent rejection for
one or few measured parameters.
9.7.5 Backflush Optical Bench Flowcell
option allows to perform a backflush onto optic flow cell* in case of needs.
*Backflush onto optic flow cell*: The system push cleaner under pressure into the flow cell in order to
remove a potential clogging. It can be used in case of permanent rejection for optic measurement.
9.7.6 Needle Dismantling
option allows moving automatically the sampling module to give the access to the
needle in case of needs (needle and/or rinse head O-ring replacement).
Hereafter the instruction to replace the needle and/or the rinse head O-ring.
1. Press , the system moves the sampling module in “Needle Disassembling

Position” and the following window is displayed.
2. Pull on the top of the needle to remove it from the needle carriage.

3. Pull on the rinsing head and remove it from the sampling module.
4. Pull up the needle to remove it from the rinsing head. Disconnect it from tubing and remove
it from the instrument.
5. If needed, replace the needle following the reverse instruction.
Wear rubber gloves and wash hands with a disinfectant after completion of
work.

9.7.7 Check Rocker
option allows controlling the functionality of the sampling module transversal axis; it
checks the motor and sensors.
9.7.8 Park Motor Syringes
option allows to place the syringe pistons into the maximum high position.
NOTE: This option is mainly used for instrument transportation in order to protect the
mechanisms.
9.7.9 Rinse
option allows the counting chambers rinsing, following tool bar indicates the
progress of the rinse cycle.
At the end of the rinse cycle the following window indicates the user that rinse cycle is completed.
9.7.10 Clean
option allows cleaning the apertures with cleaner. It performs three back flush,
a drain chambers and refill.
9.7.11 Clean and Drain for Pack up the Instrument
option allows performing a complete cleaning of the instrument. This procedure

includes cleaning MYTHIC 60 with sodium hypochloride, then rinsing with distilled water and drying.
NOTE: This option must be always used before a long term shut down.

9.7.12 Syringes Greasing
option allows moving the pistons down in order to perform the greasing.
NOTE: The piston greasing must be performed minimum every 6 months, please proceed as
describe in the procedure below.
1. Press on and wait for the following information window.
2. Wear rubber glove on one hand and place a bit of silicon grease at the tip of the index.
3. Spread a thin film of grease on each piston excepted sampling piston.
NOTE: With a tool key type T20, turn the two bigger pistons (waste pistons) in order to
spread the grease all around the pistons.

NO GREASE ON
SAMPLING PISTON
9.7.13 Check Sensors and Valves
: This option is a control panel of all the

sensors of the instrument.
 HOMES STATES
means the module is not at the

initialization position, home sensor is
not detected.
means the module is at the home

position, home sensor is detected.
 SWITCHS
means the start analysis trigger is

not activated.
means the fluidic door is closed.
 COUNT

 THERMAL
Value of vacuum/pressure measured in waste chambers.
Value of the vacuum generated by the rinse pump.
Diluent Temperature (measured by diluent t° sensor).
Reagent temperature measured by heater t° sensor.
Instrument temperature.
Percentage of heating (from 0 to 100%).
 VALVES
To test each valve, press the dedicated

button.
To test all the valves, press ALL EV ON.
To test the valves one by one, press EV

CHASER.
 CHECK DEVICE
This function allows switching ON/OFF optic LED.
This function allows switching ON the apertures current.
This function allows switching ON/OFF the Hemoglobin LED.
This function allows controlling the vacuum.
This function allows switching ON/OFF the rinse pump.

9.7.14 Check Syringes
option allows controlling the syringe module functionality, this function checks the
syringe motor and sensor.
9.7.15 Check Needle
option allows controlling the functionality of the Y axis of the sampling module, this
function checks the motor and sensors.

Chapter 10 MAINTENANCE
The quality of the results and the reliability of MYTHIC 60 are directly linked to the strict respect
of the maintenance hereafter described.
To perform the maintenance and the repairs described in this Chapter, it is

mandatory to receive adequate training, to wear rubber gloves and wash hands with
a disinfectant after completion of work.
NOTE: This maintenance table is dedicated to the user and to FSE. It is established an average
workload of 50 daily patients. For bigger workload, please increase proportionally the frequency of
maintenance actions.
Needle
Motor
Pistons O-ring
Startup Shutdown Bleach screw
greasing replaceme
greasing
nt
U  
Daily

Weekly
Semi 
annually
Annually
 

10.1 Analytical Problems
PARAMETERS PROBLEMS CONDITIONS SOLUTIONS

No results. No HGB Check the HGB LED wires.
Check the electrode wires.
No results. HGB OK Perform a Cleaning Cycle and then a Bleach cycle
WBC
if unsuccessful.
Perform a Back flush and a Cleaning Cycle and
Bad then a Bleach cycle if unsuccessful.
stability. Check if bubbles in WBC bath during the analysis
cycle.
Check the electrode wires.
No HCT nor
No results. Perform a Cleaning Cycle and then a Bleach cycle
PLT
if unsuccessful.
Perform a Back flush and a Cleaning Cycle and
RBC
then a Bleach cycle if unsuccessful.
Bad Check if bubbles in RBC bath during the analysis
HCT & PLT too
stability. cycle.
Check the level of bubbles in WBC bath during the
first dilution.
No results. Check if the GHB LED is lighted on.
Check the level bubble flow in the WBC lath
Bad
during the run cycle.
HGB stability.
Change Lyse reagent.
---
Rejection. Perform a new Start Up cycle.
*
10.2 Other Problems
ORIGIN PROBLEMS SOLUTIONS

Check the rinsing needle block (presence of
Diluent leaks around the needle
clots) and clean it if necessary.
during the run cycle.
Check the rinse pump.
Check the power supply connection wires.
Instrument No starting.
Check the power supply block
Check the level of diluent and if the supply
tubing is not pinched.
All results bad.
Verify if the diluent container is well placed at
the same level as MYTHIC 60.
Check the screen wires connection on CPU
No display.
boardflat cable.
Check the paper.
Printer No printing.
Check the electrical connection.

10.3 Troubleshooting Messages
This Chapter allows knowing what to do when a troubleshooting message appears on the screen.
In any case, if a problem is not solved, contact your distributor.
Messages Description Action/Troubleshooting
System detected optical stop cock Open the stop cock if it’s closed.
as closed. Check that the optical bench isn’t fouled up.
System detected that temperature Wait a moment, the heater will reach set
is < to 18°C or > to 36.5°C. points.
System detected a reagent Wait a moment, the heater will reach set
temperature that is < to target – points.
2.5°C.
System detect a reagent Check the heater.

temperature overflow (reagent Reboot the automaton.
temperature > 60°C).
System detected an efficiency Check the heater.

failure in the heating system Reboot the automaton.
(heating without temperature rising
during 2 minutes).
System communication with I/O Check HGB and FSC/ALL boards connection.
board is out at automaton power on. Reboot the automaton.
Auto clean cycle initiated. Press on and wait the end of the cycle.
Note: Auto Clean frequency is

adjustable in SETTINGS/OTHERS
screen.

Appears when trying to run a cycle Press on and perform a control cycle.
after an emergency stop.
Control cycle is mandatory after
emergency stop.
Trying to run a cycle while another Press on and wait the end of the cycle in
one is in progress. progress before to run another cycle.
Cycle stopped upon user request Press on and perform a control cycle.
(emergency stop button).
Press on to cancel the message.

Vacuum failure during bath draining.
1. RBC/PLT bath is not drained:
• Perform VACUUM TEST then verify
the value (410 mb +/-5%) and the
stability of the vacuum.
• Check tub #2 and #14 (clogged,
pinched or disconnected).
• Check valve #2 (clogged or damaged).
2. WBC bath is not drain:

• Perform VACUUM TEST then verify
the value (410 mb +/-5%) and the
• Check tub #1 and #14 (clogged,
pinched or disconnected).
• Check valve #1 (clogged or damaged).
3. RBC/PLT and WBC baths are not

drained:
• Perform a VACUUM TEST; verify the
value (410 mb +/-5%) and the
• Check tub #14 (clogged or pinched).
• If the vacuum is close to “0”, check
valve #8 functionality, check
tub#5;18;19;24:29 (bad connection
or disconnected).

Vacuum stability check failed during Press on to cancel the message.
syringe vacuum. Perform VACUUM TEST then verify the
value (410 mb +/-5%) and the stability of
the vacuum.
Vacuum failure during the needle Press on to cancel the message.

rinsing. 1. Perform VACUUM TEST then verify the
the vacuum.
2. Check tub #10 (pinched or clogged).
3. Check if diluent comes properly to
rinsing head.
4. Check if needle O-ring damaged.
5. Check if needle guide released.
6. Check valve #3 (clogged or damaged).
Vacuum failure at the beginning of Press on to cancel the message.

bath draining. 1. Verify diluent comes to the baths.
2. Perform VACUUM TEST then verify the
the vacuum.
3. Verify valve #1; #2 (do not close
properly).
Vacuum failure during counting Press on to cancel the message.

phase in analysis cycle. 1. Perform VACUUM TEST then verify the
the vacuum.
Pressure failure during waste Press on to cancel the message.

syringe draining. 1. Check tub #5 (pinched or clogged).
2. Check tub #23 (pinched or clogged).
3. Check valve #7 (clogged or damaged).
System detects waste container Press on , empty the waste container and
full. reset waste level in reagent menu.
Note: Waste container capacity is

adjusted in reagent menu.

The system detected the fluidic If the fluidic door is closed, verify the good
door opened. functionality of the fluidic door switch and
its physical adjustment.
The adjustment of the HGB LED is 1. Verify that WBC bath is filled with
failed. diluent during HGB LED adjustment.
2. Change HGB board.
Note: HGB LED light flux must be 3. Change WBC bath.
included in the range [18000 ;
22000] after gain adjustment.
The system detected HGB command Press on to cancel the window.

error just after switching ON the
instrument. 1. Check the HGB cable connection on HGB
board.
Note: When this error occurs the 2. Check the HGB cable connection on CPU
HGB LED is not lighted ON. board.
3. Replace the HGB board.
4. Replace the CPU board.
Motors initialization is not done. Press on to cancel the window.

Perform motors initialization.
Ex: Instrument was switched ON
with fluidic door opened.
Steps lost on the needle motor. Press on to cancel the window.
1. Check if mechanical hard point on needle

axis.
2. Check if needle bent.
3. Check the needle belt tension.
4. Check O-ring in rinsing head.
Needle cannot join its home. Press on to cancel the window.
1. Bad connection on needle sensor wiring.

2. Needle sensor is damaged.
3. Bad connection on needle motor wiring.
4. Needle motor is damaged.

5. Mechanical hard point on needle axis
which prevents the needle to reach the
home position.
Needle not in home position Press on to cancel the window.

detected before cycle performation. Perform a motor initialization.
Home needle detection error. Press on to cancel the window.

Perform motor init.
If the issue occurs again, change the sensor.
Cycle prime all is mandatory after Press on and perform a prime all cycle.
clean out.
Rinse cycle is mandatory after drain Press on and perform a rinse cycle.
cycle.
Steps loss on the sampling X axis. Press on to cancel the window.
1. Check if mechanical hard point on X axis.

2. Perform greasing of the worm wheel.
3. Check for damaged part cramping
sampling X axis to move freely.
Home sampling X axis detection Press on to cancel the window.

error. Perform motor initialization.
Startup cycle mandatory after Press on and perform startup cycle.

shutdown.
Steps loss on the syringe motor. Press on to cancel the window.
1. Perform greasing of the worm wheel.

2. Perform pistons greasing.
3. Check if tub pinched on syringe.
4. Check if valve do not open or clogged on
syringe.
5. Check if mechanical hard point on
syringe module.
6. Verify if syringe motor damaged.
Syringe can’t join its home. Press on to cancel the window.
1. Bad connection on syringe sensor wiring.

2. Syringe sensor is damaged.
3. Bad connection on syringe motor wiring.
4. Syringe motor is damaged.
5. Mechanical hard point on syringe axis
which prevents the needle to reach the
home pos.
Home syringe detection error. Press on to cancel the window.

Perform motor init.
System detects there’s no bleach Press on and perform motor init.

during bleach cycle. Redo bleach cycle adding bleach when
system require.
Steps loss on the waste motor. Press on to cancel the window.
1. Perform greasing of the wormwheel.

2. Perform pistons greasing.
3. Check if tub pinched on waste syringe.
4. Check if valve do not open or clogged on
waste syringe.
5. Check if mechanical hard point on waste
syringe module.
Verify if waste syringe motor damaged.
Waste cannot join its home. Press on to cancel the window.
1. Bad connection on waste syringe sensor

wiring.
2. Waste syringe sensor is damaged.
3. Bad connection on waste syringe motor
wiring.

4. Waste syringe motor is damaged.
5. Mechanical hard point on waste syringe
axis cramping waste syringe to reach the
home pos.
Home waste syringe detection error. Press on to cancel the window.

Perform motor init.
System detected a command error 1. Verify all connections concerning valve 1

of valve 1. (valve and CPU connectors).
2. Verify electrical continuity on the two
cables of the valve 1.
3. Replace valve 1.

6. Replace valve 2.

3. Replace valve 3.

3. Replace valve 4.

3. Replace valve 5

1. Verify all connections concerning valve 6
System detected a command error (valve and CPU connectors).
of valve 6. 2. Verify electrical continuity on the two
Replace valve 6.

3. Replace valve 7.

4. Replace valve 8.

4. Replace valve 9.
System detected a command error 1. Verify all connections concerning valve

of valve 10. 10 (valve and CPU connectors).
3. Replace valve 10.

3. Replace valve 11.
System detected a background value 1. Redo a second startup.

out of range on one or few measured 2. Perform bleach cycle.
parameters. 3. Troubleshoot on the high background of
the concerned parameter.

System detected start up cycle was Run START UP cycle.
not done.
System detected cleaner reagent Replace cleaner reagent.

bottle out of date after opening.
System detected lyse bottle is Change lyse reagent bottle.

empty.
System detected lot number already Redo using another lot number.
used.
System detected cleaner bottle is Change cleaner bottle.

empty.
System detected lyse reagent Change lyse bottle.

System detected default during Correct the default entering good data.
reagent data recording.
System detected diluent reagent is You still can perform ten analysis then
almost empty. system will generate diluent is empty.
System detected failure during Correct the default entering good data.
System detected diluent bottle is Change diluent bottle.

empty.

System detected default during Correct the default entering good data.
System detected diluent reagent Change diluent bottle.

System detected cleaner bottle You still can perform ten analysis then
almost empty. system will generate cleaner is empty.
System detected lyse bottle almost You still can perform ten analysis then
empty. system will generate lyse is empty.

Chapter 11 SHUTDOWN
1. From the main menu, press SHUTDOWN .
2. The following progress bar will be displayed.
3. The hydraulic circuit of the counting and the optic modules will be rinsed.
4. Counting chambers will be filled with cleaner reagent.
5. At the end of the shutdown cycle, MYTHIC 60 will automatically turn off.
6. Shut Down can be set to be automatically performed (see ).
NOTE: After a shutdown, it is not possible to perform an analytical cycle without performing
startup first.
Every 24 hours MYTHIC 60 must stay at least with cleaning solution, for three
hours.

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Mythic 60

Revision Nb Date Author Software Comments

02 14/11/19 KZ/SK V 0.7.3. All sections updated.

Tel : +41 (0) 22 706 1840

MYTHIC 60 Copyright© Orphée SA. All Rights Reserved. Page 2/118

MYTHIC 60 Copyright© Orphée SA. All Rights Reserved. Page 4/118

Chapter 1 SAFETY GUIDANCE

1.1 Symbols and Definitions

WARNING RISK OF DANGER. Indicates a procedure to be strictly respected in order to

NOTE Indicates important information

MYTHIC 60 Copyright© Orphée SA. All Rights Reserved. Page 6/118

1.2 Warnings and Cautions

Check if the voltage setting matches the supply voltage.

supply adapter becomes wet, unplug it before touching it.

Do not place anything on top of MYTHIC 60.

Do not use MYTHIC 60 outside.

Always replace or use parts of the equipment by original parts.

manufacturer’s instructions, the protective by the equipment may be impaired.

compliance with the local legislation.

MYTHIC 60 Copyright© Orphée SA. All Rights Reserved. Page 7/118

MYTHIC 60 Copyright© Orphée SA. All Rights Reserved. Page 8/118

White blood cell parameters: Determination

Red blood cell parameters: Determination

Platelet parameters: Determination

MYTHIC 60 Copyright© Orphée SA. All Rights Reserved. Page 9/118

MYTHIC 60 consist of the seven main parts listed below:

2.2.1 Front cover

1. Touch screen LCD display (8.4”).

MYTHIC 60 Copyright© Orphée SA. All Rights Reserved. Page 10/118

MYTHIC 60 Copyright© Orphée SA. All Rights Reserved. Page 11/118

2.2.4 Connection board

Serial Link RS232

MYTHIC 60 Copyright© Orphée SA. All Rights Reserved. Page 12/118

2.2.7 External Barcode reader & keyboard

An external keyboard is not provided.

2.3.1 Standard Configuration starter kit

MYTHIC 60 Copyright© Orphée SA. All Rights Reserved. Page 13/118

3.1 Installation Requirement

3.1.2 Installation environment

• Maximum relative humidity for temperatures up to 31 °C is 80 %, decreasing linearly to 50 % at

3.2.1 Unpacking Procedure

MYTHIC 60 is delivered in a cardboard. It is recommended to examine the package visually before

MYTHIC 60 Copyright© Orphée SA. All Rights Reserved. Page 14/118

 Sampling module located on front.

 Needle rinsing dismountable system

3.3.1 Electric and Hydraulic connections.

MYTHIC 60 Copyright© Orphée SA. All Rights Reserved. Page 15/118

Control the presence of all elements comparing to the packing list.

To connect the diluent pick up

MYTHIC 60 Copyright© Orphée SA. All Rights Reserved. Page 16/118

To connect the waste tubing, place

5. Tighten the cap of the Lyse pickup tubing (Yellow

6. Install lyse and cleaner bottles in the reagent

7. Connect the diluent pickup tubing to the diluent

DILUENT CONTAINER MUST ALWAYS BE PLACED ON THE SAME LEVEL THAN

8. Place the waste straw into a waste container.

WASTE CONTAINER MUST ALWAYS BE PLACED ON FLOOR UNDER THE

MYTHIC 60 Copyright© Orphée SA. All Rights Reserved. Page 17/118

Example of neutralization procedure usually used in a laboratory for waste material:

9. Connect the power supply cable coming from the power

10. Connect the main cord to the power supply block.

MYTHIC 60 Copyright© Orphée SA. All Rights Reserved. Page 18/118

3.3.2 User’s Identification