Orphee mythic 22 User manual

Orphée SA
19, chemin du Champ des Filles - 1228 CH-Plan Les Ouates / SWITZERLAND
Tel : [phone] Fax : [phone] - Web Site : www.orphee-medical.com
mythic 22
Cod. M22/UM-EN/006
User’s Manual

REF : M22/UM/EN/006
Page 2/99
Copyright© Orphée SA. All Rights Reserved.
MYTHIC 22
REVISIONS
Revision Nb
Date
Author
Software
Comments
01
16/11/05
HC
> V1.0
Creation
02
27/03/06
OM/HC
> V1.0.0-008
Sections 3.4.6 / 4.2 / 5.6.3 / 9.8 modified
03
25/10/06
HC/SH
> V.1.1.0
Sections 3.4.4 / 5.7 / 8.5 / 9.6 / 9.1.1 modified
04
03/05/07
HC
> V 2.0.0
Management of USB key (sections 3.3/5.10/6.2/7.2)
05
06
07/12/09
HC/CM
OM
> V2.2.0
Add flags information. (section 8.5.5 / 8.5.6)
Modify (QC & CALIBRATION )
Update Hydraulic diagram and tubing list
Update of Installation Kit
Update of Maintenance Kit
Update Hydraulic diagram and tubing list
CONTACT ADDRESS
MANUFACTURER
M
Manufactured in France for
ORPHEE SA
19, chemin du champ des filles
CH-1228 Geneva / Plan-les-Ouates
SWITZERLAND
Tel : [phone]
Fax : [phone]
http://www.orphee-medical.com
LOCAL AGENT

REF : M22/UM/EN/006
MYTHIC 22
Copyright© Orphée SA. All Rights Reserved.
Page 3/99
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
DANGER
Misuse of electrical equipment may cause electrocution, burns, fire and other hazards.
Check that the voltage setting matches the supply voltage.
Protective earthing is required, plug the MYTHIC 22 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 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 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 come into contact with surfaces which are too hot to touch.
Do not place anything on top of the MYTHIC 22
Do not use the MYTHIC 22 where aerosol sprays are being used, or where oxygen is being administred.
Do not use the MYTHIC 22 out of doors
Always switch off the MYTHIC 22 and disconnect the power adaptor before dismantling any part.
The MYTHIC 22 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 use.
- 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 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 by parts supplied by ORPHEE distributor.
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 an hydraulic 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

REF : M22/UM/EN/006
Page 4/99
Copyright© Orphée SA. All Rights Reserved.
MYTHIC 22
This equipment needs special precautions regarding general requirements for safety.
Guidance and manufacturer’s declaration – Electromagnetic emmissions
The MYTHIC 22 is intended for use in the electromagnetic environment specified below. The customer or
the user of the MYTHIC 22 should assure that it is used in such an environment.
Emmissions test
Compliance level
Electromagnetic environment - guidance
Harmonic emissions
IEC 61000-3-2
Class A
The MYTHIC 22 is suitable for use in all establishments, including
domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration – Electromagnetic immunity
The MYTHIC 22 is intended for use in the electromagnetic environment specified below. The customer or
the user of the MYTHIC 22 should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance
level
Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
Complies
Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic material, the relative
humidity should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
Complies
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
Complies
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % U T
(>95 % dip in U T) for 0,5 cycle
40 % U T
(60 % dip in U T) for 5 cycles
70 % U T
(30 % dip in U T) for 25 cycles
<5 % U T
(>95 % dip in U T) for 5 sec
Complies
Mains power quality should be that of a typical
commercial or hospital environment. If the user of the
MYTHIC 22 requires continued operation during power
mains interruptions, it is recommended that the MYTHIC
22 be powered from an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
Complies
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
or hospital environment.
NOTE U T is the a.c. mains voltage prior to application of the test level.

REF : M22/UM/EN/006
MYTHIC 22
Copyright© Orphée SA. All Rights Reserved.
Page 5/99
Guidance and manufacturer’s declaration – Electromagnetic immunity
The MYTHIC 22 is intended for use in the electromagnetic environment specified below. The customer or
the user of the MYTHIC 22 should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance
level
Electromagnetic environment - guidance
Portable and mobile RF communications equipment should
be used no closer to any part of the MYTHIC 22,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
3 Vrms
150Khz to 80Mhz
3 Vrms
d = 1,2√ P
Radiated RF
IEC 61000-4-3
3 Vrms
80Mhz to 2,5Ghz
3 Vrms
d = 1,2√ P 80MHz to 800MHz
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,ashould 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 is used exceeds the applicable RF compliance level above, the MYTHIC 22 should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting
or relocating the MYTHIC 22.
bOver the frequency range 150KHz to 80MHz, field strengths should be less than 3V/m.

REF : M22/UM/EN/006
Page 6/99
Copyright© Orphée SA. All Rights Reserved.
MYTHIC 22
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.
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
Diagnostics may cause, harmful interference and void the FCC authorization to operate this equipment.

REF : M22/UM/EN/006
MYTHIC 22
Copyright© Orphée SA. All Rights Reserved.
Page 7/99
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
Orphée S.A.
19 Chemin du Champ des Filles
1228 Plan Les Ouates
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
Mythic 22
Ref. M22OT
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.

REF : M22/UM/EN/006
Page 8/99
Copyright© Orphée SA. All Rights Reserved.
MYTHIC 22
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
IEC 60601-1-2 (2001)
EN 61000-3-2
EN 61000-3-3
EN 61000-4-2 (95) A1 (98) A2 (01)
EN 61000-4-3 (02)
EN 61000-4-4 (95) A1(01)
EN 61000-4-5 A1 (01)
EN 61000-4-6 (96) A1 (01)
EN 61000-4-11 (94) A1 (01)
EN 55011 Class B
EN 55022 Class B
IEC 61010-1 (2001)
IEC 61010-2-081 (2001)
IEC 61010-2-101 (2002)
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)
N/A
Ort, Datum / Lieu, date /
Luogo, data / Place, date
Genève le 06 Juin 2008
Name und Funktion / Nom et fonction /Nome e
funzione / Name and function
Philippe Daire
RA & QA

REF : M22/UM/EN/006
MYTHIC 22
Copyright© Orphée SA. All Rights Reserved.
Page 9/99
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 hydraulic 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
4.4.1 Recommendations ..................................................................................................................................................................................42
4.4.2 Interferences........................................................................................................................................................................................42

REF : M22/UM/EN/006
Page 10/99
Copyright© Orphée SA. All Rights Reserved.
MYTHIC 22
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
5.6 ANALYSIS ............................................................................................................................................................................................... 49
5.6.1 Introduction ...........................................................................................................................................................................................49
5.6.2 Sample Identification..........................................................................................................................................................................50
5.6.3 Sample run.............................................................................................................................................................................................. 51
5.7 RESULTS .................................................................................................................................................................................................. 52
5.8 PRINTING ................................................................................................................................................................................................ 54
5.8.1 Model report (A4) –external printer ...............................................................................................................................................54
5.8.2 Model report –Thermal printer ........................................................................................................................................................55
5.9 LOGS ........................................................................................................................................................................................................ 56
5.10 ARCHIVE ................................................................................................................................................................................................ 56
5.10.1 Results ...................................................................................................................................................................................................57
5.10.2 View........................................................................................................................................................................................................58
5.11 STAND BY AND SHUT DOWN................................................................................................................................................................. 59
6. QUALITY CONTROL .................................................................................................. 60
6.1 INTRODUCTION....................................................................................................................................................................................... 60
6.2 QC ........................................................................................................................................................................................................... 60
6.2.1 Change...................................................................................................................................................................................................... 61
6.2.2 Run control blood ..................................................................................................................................................................................62
6.2.3 Levey-Jennings graph ..........................................................................................................................................................................63
6.2.4 Restore....................................................................................................................................................................................................63
6.3 REPEATABILITY....................................................................................................................................................................................... 63
7. CALIBRATION......................................................................................................... 65
7.1 RESULTS................................................................................................................................................................................................... 66
7.1.1 Calibration blood analysis .....................................................................................................................................................................66
7.1.2 Calibration...............................................................................................................................................................................................67
7.2 TARGET VALUE MODIFICATIONS........................................................................................................................................................... 67
8. TECHNOLOGY.......................................................................................................... 69
8.1 DETECTION PRINCIPLE............................................................................................................................................................................ 69
8.1.1 WBC, RBC, PLT Counting.......................................................................................................................................................................69
8.1.2 Five part diff measurement................................................................................................................................................................70
8.1.3 Hemoglobin measurement .................................................................................................................................................................... 71
8.2 LEUCOCYTE ANALYSIS.............................................................................................................................................................................71
8.3 ERYTHROCYTE ANALYSIS ....................................................................................................................................................................... 72
8.4 ANALYSIS OF PLATELETS....................................................................................................................................................................... 73
8.5 FLAGS ...................................................................................................................................................................................................... 73
8.5.1 General Flags..........................................................................................................................................................................................73
8.5.2 Instrument Flags ..................................................................................................................................................................................74
8.5.3 Leucocytes Flags...................................................................................................................................................................................75
8.5.3 Erythrocyte and HGB Flags................................................................................................................................................................76
8.5.4 Platelet Flags .........................................................................................................................................................................................76
8.5.5 QC Flags..................................................................................................................................................................................................76
8.5.6 STARTUP Flags.....................................................................................................................................................................................76
8.6 HYDRAULIC DESCRIPTION...................................................................................................................................................................... 77
8.6.1 Sampling module.....................................................................................................................................................................................77
8.6.2 Counting bath module...........................................................................................................................................................................77
8.6.3 Syringes module ....................................................................................................................................................................................77
8.6.4 Optical manifold....................................................................................................................................................................................77
8.6.5 Optical bench.........................................................................................................................................................................................78
8.8 SOFTWARE .............................................................................................................................................................................................. 78
8.8.1 Windows ..................................................................................................................................................................................................78
8.8.2 Menu tree...............................................................................................................................................................................................78
9. SERVICE ............................................................................................................... 80
9.1 MAINTENANCE ........................................................................................................................................................................................ 80
9.1.1 Maintenance table..................................................................................................................................................................................80
9.1.2 Concentrate cleaning ............................................................................................................................................................................ 81