Orphee Mythic 22-CT User manual

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mythic 22 CT

User’s Manual

Orphée SA

19, chemin du Champ des Filles - 1228 CH-Plan Les Ouates / SWITZERLAND

Tel : +41.(0)22.884.90.90 Fax : +41.(0)22.884.90.99 - Web Site : www.orphee-medical.com

Cod. M22CT/UM-EN/003

				REF : M22CT/UM/EN/003
			REVISIONS

Revision Nb	Date	Author	Software	Comments


01	23/10/06	HC	> V1.0	Creation
02	11/01/08	HC	> V2.0	English correction, Section 4.2 modified
03	25/05/08	CM/HC	> V2.2.0	Update of the prompts

CONTACT ADDRESS

MANUFACTURER

Manufactured in France for

ORPHEE SA

19, chemin du champ des filles CH-1228 Geneva / Plan-les-Ouates SWITZERLAND

Tel : +41 (0) 22 706 1840 Fax : +41 (0) 22 794 4391

http://www.orphee-medical.com

LOCAL AGENT

Page 2/102

MYTHIC 22 CT

REF : M22CT/UM/EN/003

READ THIS BEFORE USING THE EQUIPMENT

			WARNING ! RISK OF DANGER ! Indicates a procedure to be strictly respected in
			order to avoid any risks for the operator (user) or damages on the instrument or on
			the quality of results.
			Indicates that wearing gloves is mandatory before performing the described
			operation due to risk of contact with materials that may be infectious.

			Indicates hot temperatures surfaces and risk of burns


	NOTA		Indicates important additional information
			Indicates important additional information

			DANGER
			Misuse of electrical equipment may cause electrocution, burns, fire and others hazards.

Check that the voltage setting matches the supply voltage.

Protective grounding is required, plug the MYTHIC 22 CT into a supply outlet which has an earth connection.

Preserve a good access to the supply outlet to be able to unplug the MYTHIC 22 CT 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 the MYTHIC 22 CT if it is not working properly, or if it has suffered any damage ( damage to the supply cord or its plug; damage caused by dropping the power supply adapter).

Do not let the power supply adapter or its flexible cord coming in contact with surfaces which are too hot to touch.

Do not place anything on top of the MYTHIC 22 CT

Do not use the MYTHIC 22 CT where aerosol sprays are being used, or where oxygen is being administered.

Do not use the MYTHIC 22 CT outside.

Always switch off the MYTHIC 22 CT and disconnect the power adaptor before dismantling any part.

The MYTHIC 22 CT is an automated hematology analyzer for in vitro diagnostic to be used in clinical laboratories by an authorized people.

-Only human blood or artificial control blood should be run.

-Only the reagents mentioned in this manual are permitted to be used.

-The optimum performances can be only achieved if the cleaning and maintenance procedures are carefully

followed.

Due to the use of this equipment, all parts and surfaces of the MYTHIC 22 CT are potentially infective. Wearing rubber gloves is highly recommended and after completion of work, wash hands with disinfectant.

Always replace or use parts of the equipment supplied by ORPHEE’s representative.

Basic safety precautions should always be taken. If the equipment is not used according to 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 supplied by ORPHEE) cannot be done without the ORPHEE representative authorization.

Do not open the door located on the right side of the instrument (see section 1.1.3) when a fluidic cycle is in progress for it would lead to an immediate stop. To re-start, shut the door and run a Control cycle (see section 9.3.1)

KEEP THESE INSTRUCTIONS

MYTHIC 22 CT

Page 3/102

REF : M22CT/UM/EN/003

This equipment needs special precautions regarding general requirements for safety.

Guidance and manufacturer’s declaration – Electromagnetic emissions

The MYTHIC 22 CT is intended for use in the electromagnetic environment specified below. The customer or the user of the MYTHIC 22 CT should assure that it is used in such an environment.

Emissions test	Compliance level	Electromagnetic environment - guidance
Harmonic emissions	Class A	The MYTHIC 22 CT is suitable for use in all establishments, including
		domestic establishments and those directly connected to the public
IEC 61000-3-2		low-voltage power supply network that supplies buildings used for
Voltage fluctuations/flicker	Complies	domestic purposes.
emissions
IEC 61000-3-3

Guidance and manufacturer’s declaration – Electromagnetic immunity

The MYTHIC 22 CT is intended for use in the electromagnetic environment specified below. The customer or the user of the MYTHIC 22 CT should assure that it is used in such an environment.

Immunity test	IEC 60601 test level
Electrostatic	±6 kV contact
discharge (ESD)	±8 kV air
IEC 61000-4-2
Electrical fast	±2 kV for power supply lines
transient/burst	±1 kV for input/output lines
IEC 61000-4-4
Surge	±1 kV differential mode
IEC 61000-4-5	±2 kV common mode
Voltage dips, short	<5 % UT
interruptions and	(>95 % dip in UT) for 0,5 cycle
voltage variations	40 % UT
on power supply	(60 % dip in UT) for 5 cycles
input lines	70 % UT
IEC 61000-4-11	(30 % dip in UT) for 25 cycles
	<5 % UT
	(>95 % dip in UT) for 5 sec
Power frequency	3 A/m
(50/60 Hz)
magnetic field
IEC 61000-4-8

Compliance

level

Complies

Electromagnetic environment - guidance

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the MYTHIC 22 CT requires continued operation during power

mains interruptions, it is recommended that the MYTHIC 22 CT be powered from an uninterruptible power

supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

Page 4/102

MYTHIC 22 CT

REF : M22CT/UM/EN/003

Guidance and manufacturer’s declaration – Electromagnetic immunity

The MYTHIC 22 CT is intended for use in the electromagnetic environment specified below. The customer or the user of the MYTHIC 22 CT should assure that it is used in such an environment.

Immunity test	IEC 60601 test level	Compliance	Electromagnetic environment - guidance
		level
			Portable and mobile RF communications equipment should
			be used no closer to any part of the MYTHIC 22 CT,
			including cables, than the recommended separation
			distance calculated from the equation applicable to the
			frequency of the transmitter.
			Recommended separation distance
Conducted RF	3 Vrms	3 Vrms	d = 1,2√P
IEC 61000-4-6	150Khz to 80Mhz
Radiated RF	3 Vrms	3 Vrms	d = 1,2√P 80MHz to 800MHz
IEC 61000-4-3	80Mhz to 2,5Ghz
			d = 2,3√P 800MHz to 2,5GHz
			Where P is the maximum output power rating of the
			transmitter in watts (W) according to the transmitter
			manufacturer and d is the recommended separation
			distance in meters (m).
			Field strengths from fixed RF transmitters, as
			determined by an electromagnetic site survey,a should be
			less than the compliance level in each frequency range
			Interference may occur in the vicinity of equipment
			marked with the following symbol:

NOTE 1 At 80Mhz and 800MHz, the higher frequency range applies.

NOTE 2 Theses guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM an FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should considered. If the measured field strength in the location in which the MYTHIC 22 CT is used exceeds the applicable RF compliance level above, the MYTHIC 22 CT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MYTHIC 22 CT.

bOver the frequency range 150KHz to 80MHz, field strengths should be less than 3V/m.

MYTHIC 22 CT

Page 5/102

REF : M22CT/UM/EN/003

NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

-Reorient or relocate the receiving antenna.

-Increase the separation between the equipment and receiver.

-Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

-Consult the dealer or an experienced radio/TV technician for help.

The user may find the following booklet, prepared by the Federal Communications Commission, helpful:

How to identify and Resolve Radio/TV Interference Problems. This booklet is available from the U.S. Government Printing Office, Washington, D.C. 20402, Stock No. 004-000-00345-4.

Pursuant to Part 15.21 of the FCC Rules, any changes or modifications to this equipment not expressly approved by C2

The symbol on the product 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.

Page 6/102

MYTHIC 22 CT

REF : M22CT/UM/EN/003

KONFORMITÄTSERKLÄRUNG /

DECLARATION DE CONFORMITE

DECLARATION OF CONFORMITY /

DICHIARAZIONE DI CONFORMITA

Name und Adresse der Firma

Nom et adresse de l’entreprise

Nome e indirizzo della ditta

Name and address of the firm

Wir erklären in alleiniger Verantwortung, dass

Nous déclarons sous notre propre responsabilité que Dichiariamo sotto nostra responsabilità che

We declare under our sole responsibility that

das Medizinprodukt für die In-vitro-Diagnostik le dispositif médical de diagnostic in vitro

il dispositivo medico-diagnostico in vitro the in vitro diagnostic medical device

Orphée S.A.

19 Chemin du Champ des Filles

1228 Plan Les Ouates

Mythic 22 CT

Ref. M22CT

mit folgender Klassifizierung nach der Richtlinie über In-vitro-Diagnostika 98/79/EG

avec la classification selon la directive relative aux dispositifs médicaux de diagnostic in vitro 98/79/CE con la classificazione secondo la direttiva relativa ai dispositivi medico-diagnostici in vitro 98/79/CE classified as follows according to the directive on in vitro diagnostic medical devices 98/79/EC

Produkt der Liste A, Anhang II / Dispositif de la liste A, annexe II /

Dispositivo dell’elenco A, allegato II / Device of List A, Annex II

Produkt der Liste B, Anhang II / Dispositif de la liste B, annexe II /

Dispositivo dell’elenco B, allegato II / Device of List B, Annex II

Produkt zur Eigenanwendung, das nicht in Anhang II genannt ist /

Dispositif destiné à l’autodiagnostic non listé dans l’annexe II /

Dispositivo per test autodiagnostico non elencato nell’allegato II /

Device for self-testing not listed in Annex II

Sonstiges Produkt / Autre dispositif / Altro dispostivo / Other device

allen Anforderungen der Richtlinie über In-vitro-Diagnostika 98/79/EG entspricht, die anwendbar sind.

remplit toutes les exigences de la directive relative aux dispositifs médicaux de diagnostic in vitro 98/79/CE qui le concernent.

soddisfa tutte le disposizioni della direttiva relativa ai dispositivi medico-diagnostici in vitro 98/79/CE che lo riguardano.

meets all the provisions of the directive on in vitro diagnostic medical devices 98/79/EC which apply to it.

MYTHIC 22 CT

Page 7/102

REF : M22CT/UM/EN/003

Angewandte Gemeinsame Technische Spezifikationen, harmonisierte Normen, nationale Normen oder andere normative Dokumente

Spécifications techniques communes, normes harmonisées, normes nationales et autres documents normatifs appliqués

Specifiche tecniche comuni, norme armonizzate o nazionali applicate, altri documenti normativi applicati

Applied common technical specifications, harmonised standards, national standards or other normative documents

Konformitätsbewertungsverfahren

Procédure d’évaluation de la conformité

Procedimentodi valutazionedellaconformità Conformity assessment procedure

Konformitätsbewertungsstelle (falls beigezogen) Organe respons. de l'évaluat.de la conformité(si consulté)

Organo incaric. della valutaz. della conform. (se consultato)

Notified Body (if consulted)

Ort, Datum / Lieu, date /

Luogo, data / Place, date

Genève le 19 Juin 2008

Annex III

N/A

Name und Funktion / Nom et fonction /Nome e funzione / Name and function

Philippe Daire

RA & QA

Page 8/102

MYTHIC 22 CT

REF : M22CT/UM/EN/003

TABLE OF CONTENTS

READ THIS BEFORE USING THE EQUIPMENT..........................................................................		3
1. INSTALLATION .......................................................................................................		12
1.1 UNPACKING................................................................................................................................................................................................		12
1.1.1 Introduction ............................................................................................................................................................................................		12
1.1.2 Unpacking Procedure	.............................................................................................................................................................................	12
1.1.3 Visual checking........................................................................................................................................................................................		13
1.2 INSTALLATION CONSTRAINTS...............................................................................................................................................................		13
1.2.1 Installation place....................................................................................................................................................................................		13
1.2.2 Installation environment ......................................................................................................................................................................		13
1.3 ELECTRICAL CONNECTIONS.....................................................................................................................................................................		14
1.3.1 Power supply block .................................................................................................................................................................................		14
1.4 PRINTER CONNECTION.............................................................................................................................................................................		14
1.5 CONNECTION, CHANGE AND PRIMING REAGENTS .................................................................................................................................		15
1.5.1 Connection ...............................................................................................................................................................................................		15
1.5.2 Priming .....................................................................................................................................................................................................		16
1.6 TRANSPORTATION AND STORAGE ..........................................................................................................................................................		18
2. GENERAL OVERVIEW .................................................................................................		19
2.1 GENERALITIES..........................................................................................................................................................................................		19
2.2 OVERVIEW...............................................................................................................................................................................................		20
2.3 MAIN PART DESCRIPTION......................................................................................................................................................................		20
2.3.1 Display / Keyboard ................................................................................................................................................................................		20
2.3.2 Dilution fluidic part ..............................................................................................................................................................................		22
2.3.3 Mono electronic board .........................................................................................................................................................................		23
2.3.4 Power Supply Block ...............................................................................................................................................................................		23
2.3.5 Reagent tray ..........................................................................................................................................................................................		24
3. INSTRUMENT SET UP................................................................................................		25
3.1 USER’S IDENTIFICATION ......................................................................................................................................................................		25
3.1.1 Start Up...................................................................................................................................................................................................		25
3.1.2 In process ...............................................................................................................................................................................................		25
3.2 SYSTEM STATUS.....................................................................................................................................................................................		26
3.3 SET UP .....................................................................................................................................................................................................		27
3.4 ADVANCED SET-UP..................................................................................................................................................................................		28
3.4.1 Printer set up :.......................................................................................................................................................................................		28
3.4.2 Communication: ......................................................................................................................................................................................		28
3.4.3 Analysis options:....................................................................................................................................................................................		29
3.4.4 Lab. parameters: ...................................................................................................................................................................................		29
3.4.5 Calibration factor: ................................................................................................................................................................................		33
3.4.6 Other Setting:.......................................................................................................................................................................................		33
3.4.7 Storage options :...................................................................................................................................................................................		33
3.4.8 Version release : ...................................................................................................................................................................................		34
4. SPECIFICATIONS .....................................................................................................		35
4.1 ANALYTICAL SPECIFICATIONS..............................................................................................................................................................		35
4.2 PHYSICAL SPECIFICATIONS	..................................................................................................................................................................	37
4.3 REAGENTS SPECIFICATIONS ................................................................................................................................................................		39
4.3.1 Diluent......................................................................................................................................................................................................		39
4.3.2 Lytic reagent “OnlyOne”......................................................................................................................................................................		40
4.3.3 Cleaning solution....................................................................................................................................................................................		41
4.4 ANALYTICAL LIMITATIONS...................................................................................................................................................................		42
4.3.1 Recommendations ..................................................................................................................................................................................		42
4.3.1 Interferences ........................................................................................................................................................................................		42
MYTHIC 22 CT	Copyright© Orphée SA. All Rights Reserved.	Page 9/102

		REF : M22CT/UM/EN/003
5. SAMPLE ANALYSIS ...................................................................................................		47
5.1 VERIFICATIONS BEFORE STARTING ......................................................................................................................................................		47
5.2 START UP .................................................................................................................................................................................................		47
5.3 REAGENT REPLACEMENT .........................................................................................................................................................................		48
5.4 START UP RINSING.................................................................................................................................................................................		49
5.5 PREPARATIONS BEFORE ANALYSIS .......................................................................................................................................................		49
5.5.1 Anticoagulant and mixing .....................................................................................................................................................................		49
5.5.2 Blood sample collection tube ..............................................................................................................................................................		49
5.6 ANALYSIS ...............................................................................................................................................................................................		50
5.6.1 Introduction ...........................................................................................................................................................................................		50
5.6.2 Sample Identification..........................................................................................................................................................................		51
5.6.3 Close tube sample run ..........................................................................................................................................................................		52
5.6.4 Other vials sample run.........................................................................................................................................................................		53
5.7 RESULTS ..................................................................................................................................................................................................		54
5.8 PRINTING ................................................................................................................................................................................................		56
5.8.1 Model report (A4) – external printer ...............................................................................................................................................		56
5.8.2 Model report – Thermal printer ........................................................................................................................................................		57
5.9 LOGS ........................................................................................................................................................................................................		58
5.10 ARCHIVE ................................................................................................................................................................................................		58
5.10.1 Results ...................................................................................................................................................................................................		59
5.10.2 View........................................................................................................................................................................................................		60
5.11 STAND BY AND SHUT DOWN..................................................................................................................................................................		61
6. QUALITY CONTROL ..................................................................................................		62
6.1 INTRODUCTION.......................................................................................................................................................................................		62
6.2 QC ...........................................................................................................................................................................................................		62
6.2.1 Change......................................................................................................................................................................................................		63
6.2.2 Run control blood ..................................................................................................................................................................................		64
6.2.3 Levey-Jennings graph ..........................................................................................................................................................................		65
6.2.4 Restore....................................................................................................................................................................................................		65
6.3 REPEATABILITY.......................................................................................................................................................................................		66
7. CALIBRATION .........................................................................................................		68
7.1 RUN CALIBRATOR .............................................................................................................................................................................		69
7.1.1 Calibration blood analysis .....................................................................................................................................................................		69
7.1.2 Calibration...............................................................................................................................................................................................		70
7.2 TARGET VALUE MODIFICATIONS ...........................................................................................................................................................		70
8. TECHNOLOGY..........................................................................................................		72
8.1 DETECTION PRINCIPLE............................................................................................................................................................................		72
8.1.1 WBC, RBC, PLT Counting.......................................................................................................................................................................		72
8.1.2 Five part diff measurement ................................................................................................................................................................		73
8.1.3 Hemoglobin measurement ....................................................................................................................................................................		74
8.2 LEUCOCYTE ANALYSIS............................................................................................................................................................................		74
8.3 ERYTHROCYTE ANALYSIS .......................................................................................................................................................................		75
8.4 ANALYSIS OF PLATELETS.......................................................................................................................................................................		76
8.5 FLAGS ......................................................................................................................................................................................................		76
8.5.1 General Flags ..........................................................................................................................................................................................		76
8.5.2 Instrument Flags ..................................................................................................................................................................................		77
8.5.3 Leucocytes Flags ...................................................................................................................................................................................		77
8.5.4 Erythrocyte and HGB Flags ................................................................................................................................................................		78
8.5.4 Platelet Flags .........................................................................................................................................................................................		78
8.5.5 QC Flags..................................................................................................................................................................................................		78
8.5.6 STARTUP Flags .....................................................................................................................................................................................		78
8.6 HYDRAULIC DESCRIPTION......................................................................................................................................................................		79
8.6.1 Sampling module.....................................................................................................................................................................................		79
8.6.2 Counting bath module...........................................................................................................................................................................		79
8.6.3 Syringes module ....................................................................................................................................................................................		79
8.6.4 Optical manifold....................................................................................................................................................................................		79
8.6.5 Optical bench.........................................................................................................................................................................................		80
8.8 SOFTWARE ..............................................................................................................................................................................................		80
8.8.1 Windows ..................................................................................................................................................................................................		80
8.8.2 Menu tree ...............................................................................................................................................................................................		80
9. SERVICE ...............................................................................................................		82
Page 10/102	Copyright© Orphée SA. All Rights Reserved.	MYTHIC 22 CT

REF : M22CT/UM/EN/003
9.1 MAINTENANCE ........................................................................................................................................................................................	82
9.1.1 Maintenance table..................................................................................................................................................................................	82
9.1.2 Concentrate cleaning ............................................................................................................................................................................	83
9.1.3 Piston greasing .......................................................................................................................................................................................	84
9.1.4 In line filter cleaning ............................................................................................................................................................................	85
9.2 HYDRAULIC CYCLES.................................................................................................................................................................................	86
9.3 MECHANICS.............................................................................................................................................................................................	87
9.4 REPAIRING...............................................................................................................................................................................................	88
9.4.1 Emergency stop......................................................................................................................................................................................	88
9.4.2 Needle or o-ring replacement ............................................................................................................................................................	88
9.4.3 Baths dismantling..................................................................................................................................................................................	91
9.4.4 Baths o-ring replacement....................................................................................................................................................................	94
9.4.5 Aperture block replacement...............................................................................................................................................................	94
9.5 TROUBLESHOOTING ...............................................................................................................................................................................	95
9.5.1 Analytical problems...............................................................................................................................................................................	95
9.5.2 Other problems .....................................................................................................................................................................................	96
9.6 TROUBLESHOOTING MESSAGE ..............................................................................................................................................................	97
9.7 LOGS ERRORS .........................................................................................................................................................................................	100
9.8 HYDRAULIC DIAGRAM ............................................................................................................................................................................	101

MYTHIC 22 CT

Page 11/102

1. INSTALLATION

REF : M22CT/UM/EN/003

1.INSTALLATION

1.1UNPACKING

1.1.1 Introduction

The MYTHIC 22 CT is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories by an authorized people.

-Only human blood or artificial control blood should be run.

-Only the reagents mentioned in this manual are permitted to be used.

-The optimum performances can be only achieved if the cleaning and maintenance procedures are carefully followed.

If the MYTHIC 22 CT has been stored at a temperature lower than 10°C it must be let at room temperature during 24 hours.

1.1.2 Unpacking Procedure

Before unpacking the instrument, we recommend to check the box of the instrument and notify any damage to the carrier.

-Open the box on the top, remove the starter kit.

-Remove the MYTHIC 22 CT from the box.

Starter kit contents :

	INSTALLATION KIT
QTY		Designation
1	Tubing 23 - DILUENT
1	Tubing 24 - WASTE
1	150W switching adapter
1	European Power line cord
1	MYTHIC 22	CT User manual
1	MYTHIC 22	CT Installation Report form
1	MYTHIC 22	CT Quality Control Certificate
1	Screwdriver Slot 1/4"

MAINTENANCE KIT

QTY Designation

1 Tygon tubing L=500mm 1.02mm

1 Tygon tubing L=500mm 1.3mm

1 Tygon tubing L=1000mm 1.52x3.2mm

1 Tygon tubing L=500mm 2.06x4mm

1 Tubing 50

4Bottle cap filter 1 In line filter

5Tie wraps

2 Rinsing Head O-ring

1 Silicon grease (3gr)

1 Short Arm TORX T10 Tool

1 Short Arm TORX T20 Tool

Page 12/102

MYTHIC 22 CT

REF : M22CT/UM/EN/003

1. INSTALLATION

1.1.3 Visual checking

3 2

Open the door on the right side with the key provided in the kit.

To be checked :

1- Counting chambers perfectly locked in their manifold locations.

2- Needle’s dismountable system located in the rocker. 3- Rocker in front position at the maximum course.

HAZARDOUS MOVING PARTS, BEWARE TO STAY AWAY FROM THESE PARTS WHEN THE MACHINE IS SWITCH ON.

1.2 INSTALLATION CONSTRAINTS 1.2.1 Installation place

To ensure that the MYTHIC 22 CT fulfills its function, place the instrument on a table which supports the weight of the instrument, printer and reagents (around 40 Kg). Leave a space of 10 cm in the rear of the instrument to ensure a well-ventilated place. Avoid a place that can be exposed to direct sunlight.

1.2.2Installation environment

a)Indoor use;

b)Altitude up to 2 000 m;

c)Temperature 18 °C to 34 °C;

d)Maximum relative humidity 80 % for temperatures up to 31 °C decreasing linearly to 50 % relative humidity at 40 °C;

e)MAINS supply voltage fluctuations up to ±10 % of the nominal voltage;

f)Transient over voltages typically present on the MAINS supply.

g)Rated pollution degree II.

MYTHIC 22 CT

Page 13/102

1. INSTALLATION

REF : M22CT/UM/EN/003

Please contact Orphée’s representative if you want to use the instrument in special conditions (altitude higher than 2000 m or special power supply conditions).

1.3 ELECTRICAL CONNECTIONS

All the connectors are in the rear of the MYTHIC 22 CT
CONNECTION :	SYMBOL :
- 2 USB ports :
- Ethernet connection (TCP/IP) :
- External barcode reader (RS232C) :
- Host connection (RS232C) :
- Printer connection (Centronics) :
- Power supply cord connection :
- Equipotentiality :

Any output or input connections (except the printer and the bar code reader supplied by ORPHEE) cannot be done without the ORPHEE representative authorization.

1.3.1 Power supply block

MYTHIC 22 CT must be connected to the power with the power supply block provided with the starter kit. Choose a well-ventilated place for the block and be sure to connect this power supply in a socket-outlet with a correct earth connection.

The power supply block must be placed at the rear of the MYTHIC 22 CT and, if possible in an upper position to avoid the contact with any liquid.

To disconnect electrically the MYTHIC 22 CT, remove the power supply plug from the main circuit.

In case of replacement of the main power wire, supplied with the MYTHIC 22 CT, the new one must comply with the local regulation (31.5mm cable and 250V 10A plug).

The MYTHIC 22 CT has been certified with the power supply provided with the machine. If another power supply is used with the instrument, Orphée or its representative will not apply any warranty on this power supply and on the instrument. Please contact Orphée or its local representative before to use such material.

1.4 PRINTER CONNECTION

Connect the printer cable in conformity with the printer user’s manual.

Use the parallel rear plug of the MYTHIC 22 () or the USB plug () to connect the printer cable. Select the printer driver (section 3.3).

Page 14/102

MYTHIC 22 CT

REF : M22CT/UM/EN/003

1. INSTALLATION

1.5 CONNECTION, CHANGE AND PRIMING REAGENTS

MYTHIC 22 CT works exclusively with the reagents described in section 4.3. Orphée or its local representative will not be responsible of the quality of the results and of the maintenance of the instrument if other commercial reagents are used.

1.5.1 Connection

Lytic reagent and cleaning solution :

Before handling the reagents, read carefully their specifications described in section 4.3.

-Remove the door on the left side of the instrument.

-Put the reagent bottles in the dedicated location.

-Remove the caps of the bottles.

-Tighten the red caps on the OnlyOne bottle (red sticker) and the blue one on the cleaning solution bottle (blue sticker).

Diluent and waste :

Waste

Diluent

-Connect the diluent tube (male connector) on the outlet on the bottom and tighten the cap on the diluent container.

-To use a 20 liter diluent container add the tubing straw adaptor supplied with the installation kit.

-Connect the waste tube (female connector) on the outlet on the top and tighten the cap on an empty container.

Do not modify the type and the length of the diluent and waste tubes.

The diluent must be placed on the same level as the MYTHIC 22 CT.

It is mandatory to collect the waste in a container and to treat it in compliance with your local regulation.

MYTHIC 22 CT

Page 15/102

1. INSTALLATION

REF : M22CT/UM/EN/003

1.5.2 Priming

To use the MYTHIC 22 CT for the first time, it is necessary to perform a complete prime of the fluidic circuit. This operation should be done by a Field Service Engineer.

Before starting, be sure that all the reagent and waste tubes are properly connected. The reagents must be stored 24 hours minimum at room temperature before use.

Priming procedure :

 Switch on :

-Connect the power supply block. Switch on the power supply (see section 2.3.4). The power supply can stay switch on all the time.

-Press the ON/OFF button.

-The cycle LED turns red. No cycle can be performed before it turns green.

-The information window could stay up to 3 min to enable the update of all the files.

 Login :

-The operator’s identification display appears.

-Enter the user’s identification, the password (see section 3.1) and press

to validate.

- AUTONOMY (run) indicates the number of samples (runs) you can perform (calculated with the smaller volume of reagents).

- If this window appears, it means that several results in memory have not been sent before the MYTHIC 22 was switched off.

- Press YES to send them immediately, or press LATER to postpone them or NO if you do not want to send them.

- No USB key is available, connect an USB key then press YES or see section 3.4.7 to change the archive mode.

Page 16/102

MYTHIC 22 CT

REF : M22CT/UM/EN/003

1. INSTALLATION

 System priming :

-The main menu is displayed.

-Press on .

NOTA To do an emergency stop in case of problem push shortly on the on/off button

-Press : The MYTHIC 22 CT performs a complete priming cycle.

-The cycle LED turns red. No cycle can be performed before it turns green.

-AUTONOMY (run) indicates the number of samples (runs).

-To prime or to know the quantity of reagent press the dedicated button.

-Press to display the cycle counters.

-To reset the counter with the button , please contact your Orphée’s representative.

MYTHIC 22 CT

Page 17/102

1. INSTALLATION

REF : M22CT/UM/EN/003

DILUENT PRIME:

- From the MAIN MENU press then

to have access to this screen.

-Enter lot number, the expiry date and the container capacity.

-Press to validate the new entry or after changing a new container with the same information.

-If needed enter the container volume in milliliter.

-After the replacement of a new container or to prime the diluent, press

-A new entry is automatically done in the logs (see section 5.9)

LYSE AND CLEANER PRIME:

Proceed as described above for the diluent.

WASTE :

-Enter only the capacity of the container.

-After replacement of the waste container press

to initialize the waste calculation.

MYTHIC 22 CT IS NOW READY TO WORK.

1.6 TRANSPORTATION AND STORAGE

Storage temperature: -10°C to +50°C.

If the MYTHIC 22 CT has been stored at a temperature lower than 10°C it must be left at room temperature during 24 hours.

Before transportation outside the laboratory, perform a complete cleaning with a disinfectant in compliance with the local regulation.

Page 18/102

MYTHIC 22 CT

REF : M22CT/UM/EN/003

2. GENERAL OVERVIEW

2.1 GENERALITIES

MYTHIC 22 CT is a fully automated analyzer performing hematological analysis on whole blood collected on EDTA K2 or K3 tubes .

-Sampling volume : 18,2 µl

-Two sampling mode : closed tube or other vial

-Throughput: close tube mode: > 40 samples/hour

other vial mode: > 45 samples/hour

-22 analysis parameters in DIF mode and 12 parameters in CBC mode :

Leukocyte parameters :

WBC	White Blood Cells
LYM	Lymphocytes in % & # (DIF mode only)
MON	Monocytes in % & # (DIF mode only)
NEU	Neutrophils in % & # (DIF mode only)
EOS	Eosinophils in % & # (DIF mode only)
BAS	Basophiles in % & # (DIF mode only)
Erythrocyte parameters
RBC	Red Blood Cells
HGB	Hemoglobin
HCT	Hematocrit
MCV	Mean Corpuscular Volume
MCH	Mean Corpuscular Hemoglobin
MCHC	Mean Corpuscular Hemoglobin Concentration
RDW	Red Blood cells Distribution Width
Thrombocyte parameters
PLT	Platelet
MPV	Mean Platelet Volume
PDW*	Platelet Distribution Width
PCT*	Thrombocrit

* For Investigation Use only in the United States of America

MYTHIC 22 CT

Page 19/102

2. GENERAL OVERVIEW

REF : M22CT/UM/EN/003

2.2 OVERVIEW

MYTHIC 22 CT consists of 8 main parts:

1.Display / Keyboard.

2.Dilution hydraulic part.

3.Mono electronic board.

4.Reagent tray.

5.Connection.

6.External power supply block.

7.Printer.

8.Barcode reader (option).

2.3MAIN PART DESCRIPTION

2.3.1 Display / Keyboard		Stand By and
		ON/OFF button


		Numeric keyboard


		Delete (DEL)


		Exit (ESCAPE)


		Cursors


		Enter (ENTER)


		Cycle in process
		Led


		Touch screen LCD
		display 380*240



Page 20/102	Copyright© Orphée SA. All Rights Reserved.	MYTHIC 22 CT

REF : M22CT/UM/EN/003

2. GENERAL OVERVIEW

Main Menu description

Start Up rinsing Back to previous and Blank control screen

Reagent		Analysis
replacement		performing
(section 5.3).		(section 5.5).

Print,
Send,	Direct access to
Select	Direct access to
Select	main menu
Options	main menu
Options


		Date and Time.
		Date and Time.
		System status
		(section 3.2).


		Cleaning and stand by
		mode


		Calibration
		(section 7).


		Quality Control
		(section 6).


		Patient Archive
		(section 5.10).


		Mythic Parameters
		(section 3).


		Maintenance and
		Service Menu

Mythic Events Logs

(section 5.9).

MYTHIC 22 CT

Page 21/102

2. GENERAL OVERVIEW

REF : M22CT/UM/EN/003

2.3.2 Dilution fluidic part

All the fluidic part is on the right side of the instrument and consist of only three modules:

-Sampling module :

oRocker (patented) : Manages the rise and descent of the needle.

-Syringe module (patented) consists of one block :

oReagent syringes (Diluent, lysis), sampling and air syringes.

oLiquid valve manifold assembly and tubing.

-Counting chambers :

oWBC and RBC counting chambers and hemoglobin measurement.

oLiquid valve manifold assembly and tubing.

Optical bench

Optical manifold

Sampling module

Syringe module

Counting module

Page 22/102

MYTHIC 22 CT

REF : M22CT/UM/EN/003

2. GENERAL OVERVIEW

2.3.3 Mono electronic board

The mono electronic board is located between the hydraulic part and the reagent tray. The board, driven by a 32-bit processor, manages the following parts :

-Sample needle, rocker, syringe block motors.

-Display and keyboard.

-Connexion mode (RS232, Ethernet, …).

-Printer.

-Measurement (Counting, hemoglobin measurement).

-Data processing.

-External barcode reader.

To avoid all deterioration risks, only the field service engineer can touch this electronic board.

2.3.4 Power Supply Block

Switch on/off

MYTHIC 22 CT is supplied with an external power supply block.

-In the case of replacement of the main power wire supplied with the MYTHIC 22 CT the new one must be in compliance with the local regulation.

-The MYTHIC 22 CT has been certified with the power supply box provided with the machine. - If another power supply is used with the instrument, Orphée or its representative will not apply any warranty on this power supply and on the instrument. Please contact Orphée or its local representative before to use such material.

MYTHIC 22 CT

Page 23/102

2. GENERAL OVERVIEW

REF : M22CT/UM/EN/003

2.3.5 Reagent tray

The reagent tray is dedicated to the OnlyOne lysing reagent and cleaning solution bottles.

Page 24/102

MYTHIC 22 CT

REF : M22CT/UM/EN/003

3. INSTRUMENT SET UP

3.INSTRUMENT SET UP

3.1USER’S IDENTIFICATION

3.1.1Start Up

-After the instrument’s initialization, the identification window is displayed.

-In the window , the last operator’s identification appears.

-Either the identification is yours, press and enter your

password or the identification is not, press to enter your login.

-The window enables to change the language. Press to validate it.

-AUTONOMY (run) indicates the number of samples (runs) you can perform (calculated with the smaller quantity of reagents).

-Enter your identification name with the alphabetic keyboard.

-Place the cursor in the Password window.

-Enter your password for identification.

-For the first login, MYTHIC 22 CT proposes 3 access levels :

o User : No password

o Biologist : Password by default 1- 2- 3

oService people

-Biologist Password can be modified in section 3.3.6.

3.1.2 In process

-To change operator during the process, press to return to the main menu, and then press on

-To change identification, proceed as described above (section 3.1.1).

MYTHIC 22 CT

Page 25/102

3. INSTRUMENT SET UP

REF : M22CT/UM/EN/003

-If this window appears, it means that several results in memory have not been sent before the MYTHIC 22 was switched off.

-Press YES to send them immediately, or press LATER to wait NO if you do not want to send them.

-No USB key is available, connect an USB key then press YES or see section 3.4.7 to change the archive mode.

3.2SYSTEM STATUS

-Press on the date and hour to have access to the system status window.

-Different system status information are displayed.

-To change the screen luminosity press L , N or H

-To return to the MAIN MENU press

Page 26/102

MYTHIC 22 CT

REF : M22CT/UM/EN/003

3. INSTRUMENT SET UP

3.3 SET UP

-From the MAIN MENU press on

-This menu is available for all users.

-The DATE & TIME window enables to modify the time and the date

-To select the language of the Mythic menu, choose the right one in the

Language combo box.

- : Select the printer or no printing.

- : Select the paper size per result.

- : Two SID are available; Start day SID enables to select the first SID for each new day.

- : If you want to select a new SID number

- : Biologist reserved for complete settings. (See section 3.4).

-Once modifications are done, press either to valid or to exit keeping the previous setting.

-Press to print, save or load from an USB key all the set up.

-To load new printers drivers plug the USB key then press on in the previous screen.

-Select the printer and his connection mode.

-Then press

-Press then, the driver is loaded in the MYTHIC 22CT

This prompt appears to confirm the Driver update.

- This prompt appears if the release is failed, check the USB connection or change the USB key or call your Orphée’s representative.

MYTHIC 22 CT

Page 27/102

3. INSTRUMENT SET UP

REF : M22CT/UM/EN/003

3.4ADVANCED SET-UP

-This menu is reserved to biologist (see section 3.1).

Any modifications can affect the quality of the results. We recommend modifying these values only after an Orphée’s training.

-Please refer below for the description of each key.

3.4.1Printer set up :

-Printer set up menu is intended to present the printing report

-To select an option on the report, press on the corresponding case.

-To enter a header, press key.

-To exit the menu, either press to keep the last setting, or to save the last modifications.

3.4.2Communication:

-Reserved for Field Service Engineer.

-To set up the connection between MYTHIC and Host.

Page 28/102

MYTHIC 22 CT

REF : M22CT/UM/EN/003

3. INSTRUMENT SET UP

3.4.3Analysis options:

-OPTIONS box:

o ALWAYS ID and ALWAYS PID: To run a sample, user mandatory needs to enter a ID and/or a PID.

oRUO: With tag the PCT and PDW parameters are displayed, printed and send.

oUS MODE: The Research Use Only message is printing below the printing report.

oABSOLUTE DIFF: With tag absolute values for sub-populations of leucocytes are displayed. In the other case, percentages are

displayed.

oQC ALARMS: The message “QC failed” appear below the printing report when the QC result is out of tolerance or expired; The message “QC not done” appear below the printing report when it is not run.

- : Gives a choice of three unit systems: Standard, International System, and mmol.

-CDB box: The bar code reader is dedicated to the PID or ID or SID.

-BOLD DISPLAY box: display and print in bold-faced type the different choices in this box.

Once modifications are done, press either to validate your choices or to exit keeping the previous setting.

3.4.4Lab. parameters:

-Select the blood type in the combo box then press:

to adjust the normal and panic limits (see section 3.4.4.1).

to adjust the parameters thresholds (see section 3.4.4.2).

to adjust the flags level (see section 3.4.4.3).

to adjust the corrections factors (see section 3.4.4.4).NOTA: No correction factors with type STANDARD.

- To enter a new blood type, press NOTA: The name of the first type STANDARD cannot be change.

- Press to print the blood type set up.

- allow to print all the blood type set up (about 20 pages are printed)

- only the blood type in the combo box is printed.

MYTHIC 22 CT

Page 29/102

3. INSTRUMENT SET UP

REF : M22CT/UM/EN/003

3.4.4.1 Limits :

To rename a blood type press then select it then press to accede at the alphabetic keyboard then press to validate or to exit without any modification.

-This display enables to enter normal and panic limits for every 22 parameters given by the MYTHIC 22 CT (see section 8).

-To validate the new values, press VALID key in the next page (see below).

-Once modifications are done, press to validate or to exit without any modification.

-Press to return to the parameter setting of the standard type.

Page 30/102

MYTHIC 22 CT

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