REF : M22AL/UM/EN/004
REVISIONS
Revision Nb |
Date |
Author |
Software |
Comments |
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01 |
28/05/10 |
HC |
> V0.4.0 |
Creation. |
02 |
25/06/10 |
HC |
> V0.5.0 |
Update of the entire document. |
03 |
04/08/10 |
HC |
> 1.0 |
Update of the sections 3.4.3/3.4.1/3.4.4/5.10.1/7.2 |
04 |
13/08/10 |
HC |
> 1.0 |
Add the Declaration of Conformity |
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CONTACT ADDRESS
MANUFACTURER
M
ORPHEE SA
19, chemin du champ des filles CH-1228 Plan-les-Ouates SWITZERLAND
Tel : +41 22 884 90 90 Fax : +41 22 884 90 99
http://www.orphee-medical.com
LOCAL AGENT
MYTHIC 22 AL |
Copyright© Orphee SA. All Rights Reserved. |
Page 1/109 |
REF : M22AL/UM/EN/004
WARNING
Important Safety Instructions
Must be read before attempting to install the product.
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CAUTION - RISK OF DANGER |
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Indicates a procedure to be strictly respected in order to avoid any risks for the |
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operator (user) or damages on the instrument or on the quality of results. |
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CAUTION – BIOHAZARD RISK |
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Indicates that wearing gloves is mandatory before performing the described |
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operation due to risk of contact with materials that may be infectious. |
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CAUTION – HOT SURFACE |
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Indicates hot temperatures surfaces and risk of burns |
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CAUTION – CLASS 2 LASER RADIATION |
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Indicates laser radiation and do not stare into the beam |
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NOTA |
Indicates important additional information |
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The slots and openings in the back or bottom are provided for necessary ventilation. To |
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ensure reliable operation of this apparatus or its DC adaptor, and to protect it from |
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overheating, these openings must never be blocked or covered. |
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Do not place this apparatus or its DC adaptor near or over a radiator or heat resistor, or |
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where it is exposed to direct sunlight. |
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Do not place a vessel containing liquid on this apparatus and its DC adaptor, as this can result |
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in a risk of fire or electric shock. |
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Do not expose this apparatus or its DC adaptor to rain or place it near water. If this |
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apparatus or its DC adapter accidentally gets wet, unplug it and contact your service center |
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immediately. |
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Make sure to pull out the power cord from the outlet before cleaning. |
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Do not overload wall outlets, extension cords or adaptors beyond their capacity, since this |
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can result in fire or electric shock. |
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Do not use travel power adapter |
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Power-supply cords should be routed so that they are not likely to be walked on or pinched by |
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items placed upon or against them. |
Page 2/109 Copyright© Orphee SA. All Rights Reserved. MYTHIC 22 AL
REF : M22AL/UM/EN/004
To protect apparatus or its DC adaptor from a lightning storm, or when it is left unused for long periods of time, unplug it from the wall outlet. This will prevent damage to the set due to lightning and power line surges.
Before connecting the AC power cord to the DC adaptor outlet, make sure the voltage designation of the DC adaptor corresponds to the local electrical supply.
Never insert anything metallic into the open parts of the DC adaptor. Doing so many create a danger of electric shock.
To avoid electric shock, never touch the inside of the DC adaptor.
Make sure to plug the power cord in until it is firmly inserted. When removing the power cord, make sure to hold the power plug when pulling the plug from the outlet. Do not touch the power cord or DC adaptor with wet hands.
If this apparatus does not operate normally – in particular, if there are any unusual sounds or smells coming from it – unplug it immediately and contact your service center.
Be sure to contact an authorized service center, when installing your set in a location with heavy dust, high or low temperatures, high humidity or chemical substances. Failure to do so may cause serious damage to your set.
Use only a properly grounded plug and receptacle. An improper ground may cause electric shock or equipment damage.
To disconnect the apparatus from the mains, the plug must be pulled out from the mains socket, therefore the mains plug shall be readily operable.
Do not install the product in an unstable location such as a shaky table or a location exposed to vibration.
Do not drop or impart any shock to the product. If the product is damaged, disconnect the power cord and contact your service center.
Always replace or use parts of the apparatus supplied by your service center.
The MYTHIC 22 AL 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.
All parts or surfaces of this apparatus could be potentially infective. Use adequate protection to prevent any risk of contamination (gloves, glasses, disinfectant).
The elimination of waste supplied by this apparatus must be done in compliance with your local authorities.
MYTHIC 22 AL |
Copyright© Orphee SA. All Rights Reserved. |
Page 3/109 |
REF : M22AL/UM/EN/004
ATTENTION
RAYONNEMENT LASER DE CLASSE 2
EN CAS D’OUVERTURE NE PAS REGARDER DANS LE FAISCEAU
CAUTION
CLASS 2 LASER RADIATION
WHEN OPEN DO NOT STARE INTO THE BEAM
This equipment has an embedded class 2 laser product.
By removing the protect cover operator could have exposure to hazardous laser radiation.
Do not stare into the beam
All operations of service must be do after equipment is switched off.
Wavelength: |
650nm |
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Beam divergence: |
54° |
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Pulse duration and repetition rate: 200 |
scans/s |
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Maximum power: 1mW
Page 4/109 |
Copyright© Orphee SA. All Rights Reserved. |
MYTHIC 22 AL |
REF : M22AL/UM/EN/004
This equipment needs special precautions regarding general requirements for safety.
Guidance and manufacturer’s declaration – Electromagnetic emissions
The MYTHIC 22 AL is intended for use in the electromagnetic environment specified below. The customer or the user of the MYTHIC 22 AL should assure that it is used in such an environment.
Emissions test |
Compliance level |
Electromagnetic environment - guidance |
Harmonic emissions |
Class A |
The MYTHIC 22 AL is suitable for use in all establishments, including |
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domestic establishments and those directly connected to the public |
IEC 61000-3-2 |
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low-voltage power supply network that supplies buildings used for |
Voltage fluctuations/flicker |
Complies |
domestic purposes. |
emissions |
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IEC 61000-3-3 |
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Guidance and manufacturer’s declaration – Electromagnetic immunity
The MYTHIC 22 AL is intended for use in the electromagnetic environment specified below. The customer or the user of the MYTHIC 22 AL 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 |
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Electrical fast |
±2 kV for power supply lines |
transient/burst |
±1 kV for input/output lines |
IEC 61000-4-4 |
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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 |
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<5 % UT |
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(>95 % dip in UT) for 5 sec |
Power frequency |
3 A/m |
(50/60 Hz) |
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magnetic field |
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IEC 61000-4-8 |
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Compliance
level
Complies
Complies
Complies
Complies
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.
Mains power quality should be that of a typical commercial or hospital environment. If the user of the MYTHIC 22 AL requires continued operation during power
mains interruptions, it is recommended that the MYTHIC 22 AL 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.
MYTHIC 22 AL |
Copyright© Orphee SA. All Rights Reserved. |
Page 5/109 |
REF : M22AL/UM/EN/004
Guidance and manufacturer’s declaration – Electromagnetic immunity
The MYTHIC 22 AL is intended for use in the electromagnetic environment specified below. The customer or the user of the MYTHIC 22 AL should assure that it is used in such an environment.
Immunity test |
IEC 60601 test level |
Compliance |
Electromagnetic environment - guidance |
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level |
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Portable and mobile RF communications equipment should |
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be used no closer to any part of the MYTHIC 22 AL, |
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including cables, than the recommended separation |
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distance calculated from the equation applicable to the |
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frequency of the transmitter. |
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Recommended separation distance |
Conducted RF |
3 Vrms |
3 Vrms |
d = 1,2√P |
IEC 61000-4-6 |
150Khz to 80Mhz |
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Radiated RF |
3 Vrms |
3 Vrms |
d = 1,2√P 80MHz to 800MHz |
IEC 61000-4-3 |
80Mhz to 2,5Ghz |
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d = 2,3√P 800MHz to 2,5GHz |
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Where P is the maximum output power rating of the |
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transmitter in watts (W) according to the transmitter |
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manufacturer and d is the recommended separation |
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distance in meters (m). |
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Field strengths from fixed RF transmitters, as |
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determined by an electromagnetic site survey,a should be |
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less than the compliance level in each frequency range |
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Interference may occur in the vicinity of equipment |
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marked with the following symbol: |
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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 AL is used exceeds the applicable RF compliance level above, the MYTHIC 22 AL 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 AL.
bOver the frequency range 150KHz to 80MHz, field strengths should be less than 3V/m.
Page 6/109 |
Copyright© Orphee SA. All Rights Reserved. |
MYTHIC 22 AL |
REF : M22AL/UM/EN/004
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.
MYTHIC 22 AL |
Copyright© Orphee SA. All Rights Reserved. |
Page 7/109 |
REF : M22AL/UM/EN/004
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 AL
Ref. M22AL
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.
Page 8/109 |
Copyright© Orphee SA. All Rights Reserved. |
MYTHIC 22 AL |
REF : M22AL/UM/EN/004
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
Geneva, 10.08.2010
IEC 60825-1:2007
IEC 61010-1:2001
IEC 61010-2-101:2002
IEC 61010-2-081:2001 and A1:2003 IEC 61326-2-6:2005
Annex III
N/A
Name und Funktion / Nom et fonction /Nome e funzione / Name and function
Tomasz Tuora
CEO & President
MYTHIC 22 AL |
Copyright© Orphee SA. All Rights Reserved. |
Page 9/109 |
REF : M22AL/UM/EN/004
Page 10/109 |
Copyright© Orphee SA. All Rights Reserved. |
MYTHIC 22 AL |
REF : M22AL/UM/EN/004
TABLE OF CONTENTS
1. |
INSTALLATION ..................................................................................................... |
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14 |
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1.1 |
UNPACKING .................................................................................................................................................................................................. |
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14 |
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1.1.1 |
Introduction ................................................................................................................................................................................................. |
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14 |
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1.1.2 |
Unpacking Procedure................................................................................................................................................................................... |
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14 |
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1.1.3 |
Visual checking ............................................................................................................................................................................................. |
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15 |
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1.2 |
INSTALLATION CONSTRAINTS .................................................................................................................................................................. |
16 |
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1.2.1 |
Installation place ......................................................................................................................................................................................... |
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16 |
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1.2.2 |
Installation environment ............................................................................................................................................................................ |
16 |
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1.3 |
ELECTRICAL CONNECTIONS ........................................................................................................................................................................ |
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16 |
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1.3.1 |
Rear connectors ........................................................................................................................................................................................... |
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16 |
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1.3.2 |
Front connectors ......................................................................................................................................................................................... |
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17 |
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1.3.3 |
Power supply block....................................................................................................................................................................................... |
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17 |
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1.4 |
PRINTER CONNECTION ................................................................................................................................................................................ |
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17 |
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1.5 CONNECTION, CHANGE AND PRIMING REAGENTS .................................................................................................................................... |
18 |
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1.5.1 |
Connection ..................................................................................................................................................................................................... |
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18 |
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1.5.2 |
Priming............................................................................................................................................................................................................ |
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19 |
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1.6 |
TRANSPORTATION AND STORAGE ............................................................................................................................................................. |
21 |
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2. |
GENERAL OVERVIEW ............................................................................................... |
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22 |
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2.1 |
INTENDED USE ........................................................................................................................................................................................... |
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22 |
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2.2 |
GENERALITIES............................................................................................................................................................................................ |
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22 |
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2.3 |
OVERVIEW................................................................................................................................................................................................... |
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23 |
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2.4 |
MAIN PART DESCRIPTION.......................................................................................................................................................................... |
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23 |
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2.4.1 |
Display............................................................................................................................................................................................................ |
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2.4.2 |
Dilution fluidic part ..................................................................................................................................................................................... |
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25 |
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2.4.3 |
Power Supply Block...................................................................................................................................................................................... |
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26 |
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2.4.4 |
Reagent tray ................................................................................................................................................................................................. |
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27 |
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2.4.5 |
Sampler.......................................................................................................................................................................................................... |
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27 |
3. |
INSTRUMENT SET UP.............................................................................................. |
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28 |
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3.1 |
USER’S IDENTIFICATION.......................................................................................................................................................................... |
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28 |
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3.1.1 |
Start Up Machine ........................................................................................................................................................................................ |
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28 |
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3.1.2 |
In process ..................................................................................................................................................................................................... |
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28 |
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3.2 |
SYSTEM STATUS......................................................................................................................................................................................... |
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29 |
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3.3 |
SET UP ......................................................................................................................................................................................................... |
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29 |
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3.4 |
ADVANCED SET-UP ..................................................................................................................................................................................... |
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30 |
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3.4.1 |
Sampler option: ............................................................................................................................................................................................ |
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30 |
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3.4.1 |
Analysis options: .......................................................................................................................................................................................... |
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30 |
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3.4.2 |
Lab. parameters: .......................................................................................................................................................................................... |
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31 |
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3.4.3 |
Other Setting: ............................................................................................................................................................................................. |
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34 |
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3.4.1 |
Printer set up: .............................................................................................................................................................................................. |
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34 |
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3.4.1 |
Communication:............................................................................................................................................................................................. |
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35 |
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3.4.2 |
Calibration factor:....................................................................................................................................................................................... |
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36 |
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3.4.3 |
Storage options:........................................................................................................................................................................................... |
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36 |
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3.4.4 |
Version release:............................................................................................................................................................................................ |
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37 |
4. |
SPECIFICATIONS ................................................................................................... |
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38 |
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4.1 |
ANALYTICAL SPECIFICATIONS................................................................................................................................................................. |
38 |
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4.2 |
PHYSICAL SPECIFICATIONS ...................................................................................................................................................................... |
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40 |
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4.3 |
REAGENTS SPECIFICATIONS .................................................................................................................................................................... |
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42 |
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4.3.1 |
Diluent............................................................................................................................................................................................................ |
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42 |
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4.3.2 |
Lytic reagent “OnlyOne” ............................................................................................................................................................................ |
43 |
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4.3.3 |
Cleaning solution........................................................................................................................................................................................... |
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44 |
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4.4 |
ANALYTICAL LIMITATIONS ...................................................................................................................................................................... |
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45 |
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4.4.1 |
Recommendations......................................................................................................................................................................................... |
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45 |
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4.4.2 |
Interferences............................................................................................................................................................................................... |
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45 |
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MYTHIC 22 AL |
Copyright© Orphee SA. All Rights Reserved. |
Page 11/109 |
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REF : M22AL/UM/EN/004 |
5. |
SAMPLE ANALYSIS ................................................................................................. |
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5.1 |
VERIFICATIONS BEFORE STARTING ......................................................................................................................................................... |
50 |
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5.2 |
SWITCH ON ................................................................................................................................................................................................ |
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5.3 |
REAGENT REPLACEMENT ............................................................................................................................................................................. |
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50 |
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5.4 |
START UP RINSING...................................................................................................................................................................................... |
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51 |
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5.5 |
PREPARATIONS BEFORE ANALYSIS ........................................................................................................................................................... |
52 |
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5.5.1 |
Blood collection ............................................................................................................................................................................................ |
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52 |
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5.5.2 |
Blood sample collection tube ..................................................................................................................................................................... |
52 |
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5.6 |
ANALYSIS ................................................................................................................................................................................................... |
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53 |
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5.6.1 |
Introduction ................................................................................................................................................................................................. |
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53 |
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5.6.2 |
Working rules ............................................................................................................................................................................................... |
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53 |
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5.6.3 |
Work list........................................................................................................................................................................................................ |
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54 |
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5.6.4 |
Modify an order ........................................................................................................................................................................................... |
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55 |
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5.6.5 |
New Order .................................................................................................................................................................................................... |
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55 |
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5.6.6 |
Display run..................................................................................................................................................................................................... |
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55 |
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5.6.7 |
Run Rack......................................................................................................................................................................................................... |
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56 |
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5.6.8 |
STAT or other vial Sample Identification ............................................................................................................................................. |
59 |
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5.6.9 |
STAT or other vial sample run.................................................................................................................................................................. |
60 |
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5.7 |
DISPLAY RUNS............................................................................................................................................................................................. |
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61 |
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5.8 |
PRINTING .................................................................................................................................................................................................... |
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63 |
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5.8.1 |
PCL3/LX 300 (USB) model report............................................................................................................................................................ |
63 |
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5.8.1 |
PCL6 model report ....................................................................................................................................................................................... |
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64 |
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5.9 |
LOGS INTERVENTIONS .............................................................................................................................................................................. |
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65 |
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5.10 |
ARCHIVE ...................................................................................................................................................................................................... |
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66 |
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5.10.1 |
Results ........................................................................................................................................................................................................... |
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66 |
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5.10.2 |
View ................................................................................................................................................................................................................ |
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67 |
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5.11 |
STAND BY AND SHUT DOWN...................................................................................................................................................................... |
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68 |
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6. |
QUALITY CONTROL ................................................................................................ |
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69 |
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6.1 |
INTRODUCTION .......................................................................................................................................................................................... |
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69 |
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6.2 |
QUALITY CONTROL .................................................................................................................................................................................... |
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69 |
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6.2.1 |
Change............................................................................................................................................................................................................ |
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70 |
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6.2.2 |
Run control blood ......................................................................................................................................................................................... |
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71 |
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6.3 |
REPEATABILITY .......................................................................................................................................................................................... |
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72 |
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7. |
CALIBRATION ....................................................................................................... |
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73 |
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7.1 |
RUN CALIBRATOR........................................................................................................................................................................................ |
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74 |
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7.1.1 |
Calibration blood analysis........................................................................................................................................................................... |
74 |
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7.1.2 |
Calibration ..................................................................................................................................................................................................... |
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74 |
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7.2 |
TARGET VALUES MODIFICATIONS ............................................................................................................................................................ |
75 |
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8. |
TECHNOLOGY ....................................................................................................... |
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76 |
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8.1 |
DETECTION PRINCIPLE ............................................................................................................................................................................... |
|
76 |
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8.1.1 |
WBC, RBC, PLT Counting............................................................................................................................................................................. |
76 |
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8.1.2 |
Five part diff measurement ...................................................................................................................................................................... |
77 |
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8.1.3 |
Hemoglobin measurement .......................................................................................................................................................................... |
78 |
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8.2 |
LEUKOCYTE ANALYSIS ............................................................................................................................................................................... |
|
78 |
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8.2.1 |
Measurement ................................................................................................................................................................................................ |
|
78 |
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8.2.2 |
Local blood control limitations .................................................................................................................................................................. |
79 |
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8.3 |
ERYTHROCYTE ANALYSIS........................................................................................................................................................................... |
|
80 |
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8.4 |
ANALYSIS OF PLATELETS ........................................................................................................................................................................... |
|
81 |
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8.5 |
FLAGS ........................................................................................................................................................................................................... |
|
81 |
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8.5.1 |
General Flags ................................................................................................................................................................................................ |
|
81 |
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8.5.2 |
Instrument Flags ......................................................................................................................................................................................... |
|
82 |
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8.5.3 |
Leukocytes Flags.......................................................................................................................................................................................... |
|
82 |
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8.5.4 |
Erythrocyte and HGB Flags....................................................................................................................................................................... |
83 |
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8.5.5 |
Platelet Flags ................................................................................................................................................................................................ |
|
83 |
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8.5.6 |
QC Flags ........................................................................................................................................................................................................ |
|
83 |
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8.5.7 |
STARTUP Flags............................................................................................................................................................................................ |
|
83 |
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8.6 |
HYDRAULIC & MECHANIC DESCRIPTION .................................................................................................................................................. |
84 |
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8.6.1 |
Auto loader module...................................................................................................................................................................................... |
|
84 |
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8.6.2 |
Sampling module........................................................................................................................................................................................... |
|
84 |
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8.6.3 |
Counting bath module.................................................................................................................................................................................. |
|
84 |
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8.6.4 |
Syringes module ........................................................................................................................................................................................... |
|
84 |
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8.6.5 |
Optical manifold........................................................................................................................................................................................... |
|
84 |
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Page 12/109 |
Copyright© Orphee SA. All Rights Reserved. |
MYTHIC 22 AL |
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REF : M22AL/UM/EN/004
|
8.6.6 |
Optical bench................................................................................................................................................................................................ |
85 |
8.7 |
SOFTWARE .................................................................................................................................................................................................. |
85 |
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8.7.1 |
Common Functionalities .............................................................................................................................................................................. |
85 |
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8.7.2 |
Menu tree ...................................................................................................................................................................................................... |
86 |
9. SERVICE ............................................................................................................. |
87 |
||
9.1 |
MAINTENANCE ........................................................................................................................................................................................... |
87 |
|
|
9.1.1 |
Maintenance table ....................................................................................................................................................................................... |
87 |
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9.1.2 |
Concentrate cleaning................................................................................................................................................................................... |
88 |
|
9.1.3 |
Piston greasing ............................................................................................................................................................................................. |
90 |
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9.1.4 |
In line filter cleaning .................................................................................................................................................................................. |
91 |
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9.1.5 |
Barcode cleaning .......................................................................................................................................................................................... |
91 |
9.2 |
CLEANING CYCLES....................................................................................................................................................................................... |
92 |
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9.3 |
TROUBLESHOOTING SCREEN..................................................................................................................................................................... |
92 |
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9.3.1 |
Sampler.......................................................................................................................................................................................................... |
93 |
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9.3.2 |
Check sensors............................................................................................................................................................................................... |
93 |
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9.3.3 |
Check valves.................................................................................................................................................................................................. |
93 |
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9.3.4 |
Check motors fluidics ................................................................................................................................................................................. |
94 |
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9.3.5 |
Log errors...................................................................................................................................................................................................... |
94 |
9.4 |
REPAIRING .................................................................................................................................................................................................. |
94 |
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9.4.1 |
Emergency stop............................................................................................................................................................................................ |
94 |
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9.4.2 |
Needle or o-ring replacement ................................................................................................................................................................... |
95 |
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9.4.3 |
Baths dismantling......................................................................................................................................................................................... |
98 |
|
9.4.4 |
Baths o-ring replacement......................................................................................................................................................................... |
100 |
|
9.4.5 |
Aperture block replacement..................................................................................................................................................................... |
101 |
9.5 |
TROUBLESHOOTING OCCURENCES........................................................................................................................................................... |
102 |
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9.5.1 |
Analytical problems ................................................................................................................................................................................... |
102 |
|
9.5.2 |
Other problems.......................................................................................................................................................................................... |
103 |
9.6 |
TROUBLESHOOTING MESSAGE ................................................................................................................................................................. |
105 |
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9.7 |
HYDRAULIC DIAGRAM................................................................................................................................................................................ |
108 |
|
MYTHIC 22 AL |
Copyright© Orphee SA. All Rights Reserved. |
Page 13/109 |
1. INSTALLATION
REF : M22AL/UM/EN/004
1.INSTALLATION
1.1UNPACKING
1.1.1Introduction
The MYTHIC 22 AL is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories by an authorized and trained people.
-Only human blood or artificial blood (recommended control or calibrator) should be run.
-Only the reagents mentioned in this manual are permitted to be used.
-The optimum performances can only be achieved if the cleaning and maintenance procedures are carefully followed (see section 9.1).
If the MYTHIC 22 AL has been stored at a temperature lower than 10°C it must be left at room temperature during 24 hours before power on.
1.1.2Unpacking 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 AL from the box.
Starter kit contents:
|
|
INSTALLATION KIT |
QTY |
|
Designation |
1 |
Tubing 23 |
- DILUENT |
1 |
Tubing 24 |
- WASTE |
1 |
150W DC adaptor |
|
1 |
European Power line cord |
|
1 |
MYTHIC 22 AL User’s manual |
|
1 |
Screwdriver Slot 1/4" |
|
10 |
Racks |
|
|
MAINTENANCE KIT |
QTY |
Designation |
1 |
Tubing 50 |
10 |
Silicon Sleeve |
5 |
Tie wraps |
2 |
Rinsing Head O-ring |
1 |
Silicon grease (3gr) |
1 |
Short Arm TORX T10 Tool |
1 |
Short Arm TORX T20 Tool |
Page 14/109 |
Copyright© Orphee SA. All Rights Reserved. |
MYTHIC 22 AL |
REF : M22AL/UM/EN/004
1. INSTALLATION
1.1.3Visual checking
3
1
2
-Open the door on the right side by unscrewing the two quarter turn screws with the key provided in the kit.
-Open completely the door, then lift it to remove.
- Unscrew the two quarter turn screws with the key provided in the kit.
- To remove the unloading table, push to the back first then lift it.
- Check the good fixation of the air pump.
Remove the plastic wedge of the bath block. 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 SWITCHED ON. THE BARCODE READER IS A LASER CLASS II; NEVER DISMANTLE THE COVER, IN CASE OF PROBLEM CALL ORPHEE REPRESENTATIVE.
MYTHIC 22 AL |
Copyright© Orphee SA. All Rights Reserved. |
Page 15/109 |
1. INSTALLATION
REF : M22AL/UM/EN/004
1.2INSTALLATION CONSTRAINTS
1.2.1Installation place
To ensure that the MYTHIC 22 AL fulfills its function, place the instrument on a table which supports the weight of the instrument, printer and reagents (~40 Kg). Leave a space of 10 cm at the rear of the instrument to ensure a wellventilated place. Avoid a place that can be exposed to direct sunlight.
1.2.2Installation environment
a)Indoor use;
b)Altitude up to 3 000 m (see NOTA hereafter);
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)MAIN supply voltage fluctuations up to ±10 % of the nominal voltage;
f)Transient over voltages typically present on the MAIN supply.
g)Rated pollution degree II.
NOTA |
Please contact Orphee’s representative if you want to use the instrument in special conditions (altitude higher |
|
than 2000 m or special power supply conditions). |
||
|
1.3ELECTRICAL CONNECTIONS
1.3.1Rear connectors
CONNECTION : SYMBOL :
-Not available
-1 USB port:
This USB port can be used ONLY for the printer connection.
- Ethernet connection (TCP/IP):
- Host connection (RS232C):
- External barcode reader (RS232C):
- Equipotentiality:
- Power supply cord connection:
Page 16/109 |
Copyright© Orphee SA. All Rights Reserved. |
MYTHIC 22 AL |
REF : M22AL/UM/EN/004
1. INSTALLATION
1.3.2Front connectors
3 USB ports
Any output or input connections (except the printer and the barcode reader supplied by ORPHEE) cannot be done without the ORPHEE’s representative authorization.
1.3.3Power supply block
MYTHIC 22 AL 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 AL and, if possible, in an upper position to avoid the contact with any liquid.
To disconnect electrically the MYTHIC 22 AL, remove the power supply plug from the main circuit.
In case of replacement of the main power wire, supplied with the MYTHIC 22 AL, the new one must comply with the local regulation (31.5mm cable and 250V 10A plug).
The MYTHIC 22 AL has been certified with the power supply provided with the instrument. If another power supply is used with the instrument, Orphee or its representative will not apply any warranty on this power supply and on the instrument. Please contact Orphee or its local representative before using such material.
1.4PRINTER CONNECTION
Connect the printer cable in conformity with the printer user’s manual.
Use ONLY the rear USB plug (
) of the MYTHIC 22 AL to connect the printer cable. Select the printer driver (section 3.3).
MYTHIC 22 AL |
Copyright© Orphee SA. All Rights Reserved. |
Page 17/109 |
1. INSTALLATION
REF : M22AL/UM/EN/004
1.5CONNECTION, CHANGE AND PRIMING REAGENTS
MYTHIC 22 AL works exclusively with the reagents described in section 4.3. Orphee or its local representative will not be responsible for the quality of the results and for the maintenance of the instrument if other commercial reagents are used.
1.5.1Connection
Lytic reagent and cleaning solution:
Before handling the reagents, read carefully their specifications described in section 4.3 and check if their shelf life dates are not reached.
-Remove the door on the left side of the instrument.
-Put the reagent bottles into 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:
-Connect the diluent tube (male connector) on the outlet on the bottom and tighten the cap on the diluent container.
-To use 20 liters 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 at the same level as the MYTHIC 22 AL.
Diluent Waste
It is mandatory to collect the waste in a container and to treat it in compliance with your local regulations.
Page 18/109 |
Copyright© Orphee SA. All Rights Reserved. |
MYTHIC 22 AL |
REF : M22AL/UM/EN/004
1. INSTALLATION
1.5.2Priming
When using the MYTHIC 22 AL 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 (see section 2.3.4).
-Press the ON/OFF button. 
-The logo Orphee appears during a few seconds.
Login:
-The operator’s identification display appears.
-Enter the user’s identification, the password (see section
3.1).
-To validate or not the modification, see section 8.7.1.
-AUTONOMY (run) indicates the number of samples (runs) you can perform (calculated with the smaller volume of reagents).
MYTHIC 22 AL |
Copyright© Orphee SA. All Rights Reserved. |
Page 19/109 |
1. INSTALLATION
REF : M22AL/UM/EN/004
System priming:
-The main menu is displayed.
-Press on 
.
NOTA To do an emergency stop in case of problem
push briefly on the on/off button
-Press 
: The MYTHIC 22 AL performs a complete priming cycle.
-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 Orphee’s representative.
Page 20/109 |
Copyright© Orphee SA. All Rights Reserved. |
MYTHIC 22 AL |
REF : M22AL/UM/EN/004
1. INSTALLATION
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)
- To validate or not the modification, see section 8.7.1.
LYSE AND CLEANER PRIME:
Proceed as described above for the diluent.
WASTE:
-Only enter the capacity of the container.
-After replacement of the waste container, press
to initialize the waste calculation.
- To validate or not the modification, see section 8.7.1.
MYTHIC 22 AL IS NOW READY TO OPERATE.
1.6TRANSPORTATION AND STORAGE
Before transportation outside the laboratory, perform a complete cleaning with a disinfectant in compliance with the local regulations.
Storage temperature: -10°C to +50°C.
If the MYTHIC 22 AL has been stored at a temperature lower than 10°C, it must be left at room temperature during 24 hours.
MYTHIC 22 AL |
Copyright© Orphee SA. All Rights Reserved. |
Page 21/109 |
2. GENERAL OVERVIEW
REF : M22AL/UM/EN/004
2. GENERAL OVERVIEW
2.1INTENDED USE
The MYTHIC 22 AL is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories by an authorized and trained people.
-Only human blood or artificial blood (recommended control or calibrator) 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 (see section 9.1).
2.2GENERALITIES
MYTHIC 22 AL is a fully automated analyzer performing hematological analysis on whole blood collected on EDTA K2 or K3 tubes.
-Sampling volume: 18,2 µl (inside the needle, the total volume could be upper according to the blood remaining outside of the needle).
- |
Two sampling modes: |
- closed tube in 10 racks of 5 tubes |
-opened other vial in a special position (front door open)
-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 |
Basophils 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
Page 22/109 |
Copyright© Orphee SA. All Rights Reserved. |
MYTHIC 22 AL |
REF : M22AL/UM/EN/004
2. GENERAL OVERVIEW
2.3OVERVIEW
MYTHIC 22 AL consists of 9 main parts:
1.Auto loader system
2.Display.
3.Dilution hydraulic part.
4.Mono electronic board.
5.Reagent tray.
6.Connection.
7.External power supply block.
8.Printer.
9.Barcode reader (option).
2.4MAIN PART DESCRIPTION
2.4.1Display
Use only a soft paper to clean the screen, never use direct liquid otherwise the screen could be damaged.
MYTHIC 22 AL |
Copyright© Orphee SA. All Rights Reserved. |
Page 23/109 |
2. GENERAL OVERVIEW
REF : M22AL/UM/EN/004
Main Menu description
|
|
Start Up |
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Print, |
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Direct |
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Display of |
||||
Back to |
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rinsing and |
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|||
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Send, |
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||||
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|
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access to |
|
the sampler |
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previous |
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blank control |
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|||
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Select |
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|
||||
|
|
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main menu |
|
status |
|||
screen |
|
(Section 5.2) |
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Options |
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||||
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|||
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Cleaning and |
|
Work list |
|
Log In and |
|
Calibration |
standby mode |
|
management and |
|
Log Out |
|
(Section 7). |
(section 5.11) |
|
Analysis |
|
(section 3.1) |
|
|
|
|
performing |
|
|
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|
|
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(section 5.5). |
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Date and Time. System status (Section 3.2).
Reagent replacement (section 5.3).
Mythic Parameters (Section 3).
Quality Control (Section 6).
Maintenance and
Service Menu
Mythic Events Logs (Section 5.9).
Full screen run displayed (Section 3.1).
System init (Section 9.4.1)
Patient Archive (Section 5.10)
Page 24/109 |
Copyright© Orphee SA. All Rights Reserved. |
MYTHIC 22 AL |
REF : M22AL/UM/EN/004
2. GENERAL OVERVIEW
2.4.2Dilution fluidic part
All the fluidic part is on the right side of the instrument and consists of five modules only:
-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 Manifold :
oLiquid valve manifold assembly and tubing.
-Optical bench :
oOptical bench (patented) with its flow cell (patented).
Optical bench
Optical manifold
Sampling module
Syringe module
Counting module
MYTHIC 22 AL |
Copyright© Orphee SA. All Rights Reserved. |
Page 25/109 |
2. GENERAL OVERVIEW
REF : M22AL/UM/EN/004
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:
-Fluidics: sample needle, rocker, syringe block motors.
-Autoloader: loading, transfer, mixing and unloading.
-Display and keyboard.
-Connection mode (RS232, Ethernet …).
-Printer.
-Measurement (Optical and resistive counting, hemoglobin measurement).
-Data processing.
-External barcode reader.
To avoid all deterioration risks, only the field service engineer may touch this electronic board.
2.4.3Power Supply Block
MYTHIC 22 AL is supplied with an external power supply block.
-In case of replacement of the main power wire supplied with the MYTHIC 22 AL, the new one must be in compliance with the local regulations.
-The MYTHIC 22 AL has been certified with the power supply box provided with the machine. - If another power supply is used with the instrument, Orphee or its representative will not apply any warranty on this power supply and on the instrument. Please contact Orphee or its local representative before using such material.
Page 26/109 |
Copyright© Orphee SA. All Rights Reserved. |
MYTHIC 22 AL |
REF : M22AL/UM/EN/004
2. GENERAL OVERVIEW
2.4.4Reagent tray
The reagent tray is dedicated to the OnlyOne lysing reagent and cleaning solution bottles.
2.4.5Sampler
-This module enables to load, transfer, mix and unload the racks. Ten racks of five tubes can be loaded. The loading can be done continually.
-The rack are loaded on the guide rail by a loading screw then displaced by another screw (transfer screw).
-The rail which maintains the rack can also rotated for mixing the blood inside the tubes.
-When all the samplings are performed for a rack, it is unloaded by the unloading motor.
MYTHIC 22 AL |
Copyright© Orphee SA. All Rights Reserved. |
Page 27/109 |
3. INSTRUMENT SET UP
REF : M22AL/UM/EN/004
3.INSTRUMENT SET UP
3.1USER’S IDENTIFICATION
3.1.1Start Up Machine
-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, enter your login with the keyboard.
-The window 
enables to change the language.
-To validate or not the modification, see section 8.7.1.
-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 AL 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.
3.1.2In 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).
Page 28/109 |
Copyright© Orphee SA. All Rights Reserved. |
MYTHIC 22 AL |
REF : M22AL/UM/EN/004
3. INSTRUMENT SET UP
3.2SYSTEM STATUS
- Press on the date and hour 
to have access to the system information window.
-Press on 
to have access to the status of the MYTHIC 22 AL.
-Different information are displayed:
Name of the operator
Level of access
Name of the cycle in progress
Number of racks
3.3SET UP
-From the MAIN MENU press on 
-This menu is available for all users.
-The DATE & TIME window enables to modify the time, the date and the day.
-To select the language of the Mythic menu, choose the right one in the LANGUAGE combo box.
-PRINTER: Select the printer or no printing.
-PAPER SIZE: Select the paper size per result.
-Two SID are available;
START DAY SID enables to select the first SID for each new day.
CURRENT SID enables to fix the beginning of the current SID number (which will be used in the AUTO SID number in the work list, see section 5.6.2)
-
: Biologist reserved for complete settings. (See section 3.4).
-To validate or not the modification, see section 8.7.1.
-Press 
to save, load (RESTORE), print or delete all the settings, from an USB key. Three pages are required to print all the settings.
MYTHIC 22 AL |
Copyright© Orphee SA. All Rights Reserved. |
Page 29/109 |
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