Orphee Mythic 22 User manual

mythic 22

User’s Manual

Orphée SA

19, chemin du Champ des Filles - 1228 CH-Plan Les Ouates / SWITZERLAND Tel : +41.(0)22.706.18.40 Fax : +41.(0)22.794.43.91 - Web Site : www.orphee-medical.com

Cod. M22/UM-EN/006

REF : M22/UM/EN/006

Page 2/99

MYTHIC 22

Revision Nb

Date

Author

Software

Comments

16/11/05

> V1.0

Creation

27/03/06

OM/HC

> V1.0.0-008

Sections 3.4.6 / 4.2 / 5.6.3 / 9.8 modified

25/10/06

HC/SH

> V.1.1.0

Sections 3.4.4 / 5.7 / 8.5 / 9.6 / 9.1.1 modified

03/05/07

> V 2.0.0

Management of USB key (sections 3.3/5.10/6.2/7.2)

07/12/09

HC/CM

> 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

Manufactured in France for

ORPHEE SA

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

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

http://www.orphee-medical.com

CONTACT ADDRESS

MANUFACTURER

REVISIONS

LOCAL AGENT

REF : M22/UM/EN/006

MYTHIC 22

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

KEEP THESE INSTRUCTIONS

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)

REF : M22/UM/EN/006

Page 4/99

MYTHIC 22

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 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) 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 UT is the a.c. mains voltage prior to application of the test level.

This equipment needs special precautions regarding general requirements for safety.

REF : M22/UM/EN/006

MYTHIC 22

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

= 1,2√P

Radiated RF IEC 61000-4-3

3 Vrms 80Mhz to 2,5Ghz

3 Vrms

= 1,2√P 80MHz to 800MHz

= 2,3√P 800MHz to 2,5GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range

Interference may occur in the vicinity of equipment marked with the following symbol:

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

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

Field 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.

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

REF : M22/UM/EN/006

Page 6/99

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

REF : M22/UM/EN/006

MYTHIC 22

Page 7/99

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.

KONFORMITÄTSERKLÄRUNG /

DECLARATION DE CONFORMITE

DECLARATION OF CONFORMITY /

DICHIARAZIONE DI CONFORMITA

REF : M22/UM/EN/006

Page 8/99

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

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

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

REF : M22/UM/EN/006

MYTHIC 22

Page 11/99

9.1.3 Piston greasing ....................................................................................................................................................................................... 82

9.2 HYDRAULIC CYCLES ................................................................................................................................................................................. 83

9.3 MECHANICS............................................................................................................................................................................................. 84

9.4 REPAIRING............................................................................................................................................................................................... 85

9.4.1 Emergency stop ...................................................................................................................................................................................... 85

9.4.2 Needle or o-ring replacement ............................................................................................................................................................ 86

9.4.3 Baths dismantling .................................................................................................................................................................................. 88

9.4.4 Baths o-ring replacement .................................................................................................................................................................... 91

9.4.5 Aperture block replacement ............................................................................................................................................................... 91

9.5 TROUBLESHOOTING ............................................................................................................................................................................... 92

9.5.1 Analytical problems ............................................................................................................................................................................... 92

9.5.2 Other problems ..................................................................................................................................................................................... 93

9.6 TROUBLESHOOTING MESSAGE .............................................................................................................................................................. 93

9.7 LOGS ERRORS .......................................................................................................................................................................................... 97

9.8 HYDRAULIC DIAGRAM ............................................................................................................................................................................. 98

1. INSTALLATION

REF : M22/UM/EN/006

Page 12/99

MYTHIC 22

If the MYTHIC 22 has been stored at a temperature less than 10°C it must be left at room temperature during 24 hours. It must be calibrated at each displacement and installation (See section 7).

INSTALLATION KIT

QTY

Designation

Tubing DILUENT

Tubing WASTE

150W switching adapter

European Power line cord

MYTHIC 22 User manual

MYTHIC 22 Installation Report

MYTHIC 22 Quality Control Certificate

Screwdriver Slot 1/4"

MAINTENANCE KIT

QTY

Designation

Tygon tubing L=500mm 1.02mm

Tygon tubing L=500mm 1.3mm

Tygon tubing L=1000mm 1.52x3.2mm

Tygon tubing L=500mm 2.06x4mm

Tubing 10

Tubing 50

Cables Ties

Rinsing Head O-ring

Silicon grease (3gr)

Short Arm TORX T10 Tool

Short Arm TORX T20 Tool

1. INSTALLATION

1.1 UNPACKING

1.1.1 Introduction

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.

1.1.2 Unpacking Procedure

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

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

- Remove the MYTHIC 22 from the box.

Starter kit contents:

REF : M22/UM/EN/006

1. INSTALLATION

MYTHIC 22

Page 13/99

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

kit.

To be checked :

1- Counting chambers perfectly locked in their manifold

locations.

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

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

1.1.3 Visual checking

1.2 INSTALLATION CONSTRAINTS

1.2.1 Installation place

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

1.2.2 Installation environment

a) Indoor use; b) Altitude up to 2 000 m; c) Temperature 18 °C to 34 °C; d) Maximum relative humidity 80 % for temperatures up to 31 °C decreasing linearly to 50 % relative humidity at 40 °C; e) MAINS supply voltage fluctuations up to ±10 % of the nominal voltage; f) Transient over voltages typically present on the MAINS supply. g) Rated pollution degree II.

1. INSTALLATION

REF : M22/UM/EN/006

Page 14/99

MYTHIC 22

CONNECTION :

SYMBOL :

- 2 USB ports (section 3.4.7) :

- Ethernet connection (TCP/IP) :

- External barcode reader (RS232C) :

- Host connection (RS232C) :

- Printer connection (Centronics) :

- Power supply cord connection :

- Equipotentiality :

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

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

- The MYTHIC 22 has been certified with the power supply box provided with the machine. The use of another external power supply box is not guaranteed. Please contact your Orphée’s representative.

Please contact Orphée’s representative if you want to use the instrument in special conditions (height higher

than 2000 m or special power supply conditions).

1.3 ELECTRICAL CONNECTIONS

All the connectors are in the rear of the MYTHIC 22

1.3.1 Power supply block

MYTHIC 22 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 and, if possible in an upper position to avoid the contact with any liquid. To disconnect electrically the MYTHIC 22, remove the power supply plug from the main circuit.

1.4 PRINTER CONNECTION

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

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

REF : M22/UM/EN/006

1. INSTALLATION

MYTHIC 22

Page 15/99

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

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

- Put the reagent bottles in the dedicated location.

- Remove the caps of the bottles

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

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

- To use a 20 liter diluent container adds 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.

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

Diluent

Waste

1.5 CONNECTION, CHANGE AND PRIMING REAGENTS

MYTHIC 22 works with the reagents described in section 4.3. Some commercial reagents can also be used. Please contact your Orphée’s representative.

1.5.1 Connection

Lysis reagent and cleaning solution:

Diluent and waste:

1. INSTALLATION

REF : M22/UM/EN/006

Page 16/99

MYTHIC 22

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.

1.5.2 Priming

When first starting the MYTHIC 22, it is necessary to perform a complete prime of the fluidic circuit.

Priming procedure :

 Switch on:

- Connect the power supply block.

- Press the ON/OFF button.

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

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

 Login:

- The operator’s identification display appears.

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

to validate.

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

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

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

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

REF : M22/UM/EN/006

1. INSTALLATION

MYTHIC 22

Page 17/99

NOTA

To do an emergency stop push shortly on the switch on/off

button

 System priming:

- The main menu is displayed.

- Press on .

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

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

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

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

- Press to visualize the cycle counters.

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

1. INSTALLATION

REF : M22/UM/EN/006

Page 18/99

MYTHIC 22

MYTHIC 22 IS NOW READY TO WORK.

DILUENT PRIME:

- From the MAIN MENU press then

- 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.

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

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

LYSE AND CLEANER PRIME: Proceed as described above for the diluent.

WASTE:

- Enter only the capacity of the container.

- After replacement of the waste container press

to have access to this screen.

to reset to initialize the waste calculation.

1.6 TRANSPORTATION AND STORAGE

Storage temperature: -10°C to +50°C. If the MYTHIC 22 has been stored at a temperature less than 10°C it must be left at room temperature during 24 hours. Before transportation outside the laboratory, perform a complete cleaning with a disinfectant in compliance with the local legislation.

REF : M22/UM/EN/006

2. GENERAL OVERVIEW

MYTHIC 22

Page 19/99

2. GENERAL OVERVIEW

2.1 GENERALITIES

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

- Sample volume: 15,7 µl (inside the needle, the total volume could be upper in function of the blood

remaining outside of the needle).

- Throughput: > 45 samples/hour

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

Leukocyte parameters: WBC White Blood Cells LYM Lymphocytes in % & # (DIF mode only) MON Monocytes in % & # (DIF mode only) NEU Neutrophils in % & # (DIF mode only) EOS Eosinophils in % & # (DIF mode only) BAS Basophiles in % & # (DIF mode only)

Erythrocyte parameters: RBC Red Blood Cells HGB Hemoglobin HCT Hematocrit MCV Mean Corpuscular Volume MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration RDW Red Blood cells Distribution Width

Thrombocyte parameters: PLT Platelet MPV Mean Platelet Volume PDW* Platelet Distribution Width PCT* Thrombocrit

* For Investigation Use only in the United States of America

2. GENERAL OVERVIEW

REF : M22/UM/EN/006

Page 20/99

MYTHIC 22

Stand By and ON/OFF button

Numeric keyboard

Delete (DEL)

Exit (ESCAPE)

Cursors

Enter (ENTER)

Cycle in process Led

Touch screen LCD display 380*240

2.2 OVERVIEW

2.3 MAIN PART DESCRIPTION

2.3.1 Display / Keyboard

MYTHIC 22 consists of 8 main parts:

1. Display / Keyboard.

2. Dilution hydraulic part.

3. Mono electronic board.

4. Reagent tray.

5. Connection.

6. External power supply block.

7. Printer.

8. Barcode reader (option).

REF : M22/UM/EN/006

2. GENERAL OVERVIEW

MYTHIC 22

Page 21/99

Back to previous screen

Print, Send, Select Options

Direct access to main menu

Start Up rinsing and blank control

Cleaning and standby mode

Patient Archive (Section 5.10).

Quality Control (Section 6).

Calibration (Section 7).

Mythic setting parameters (Section 3).

Maintenance and Service Menu

Analysis performing (Section 5.5).

Mythic Events Logs (Section 5.9).

Reagents replacement (Section 5.3).

Date and time. System status (Section 3.2).

Main Menu description

2. GENERAL OVERVIEW

REF : M22/UM/EN/006

Page 22/99

MYTHIC 22

Sampling module

Syringe module

Counting module

Optical manifold

Optical bench

2.3.2 Dilution hydraulic part

All the fluidic part is on the right side of the instrument and consists of only five modules:

- Sampling module : o Rocker (patent pending): Manages the rise and descent of the needle.

- Syringe module (patent pending) consists of one block :

o Reagent syringes (Diluent, lysis), sampling and air syringes. o Liquid valve manifold assembly and tubing.

- Counting chambers :

o WBC and RBC counting chambers and hemoglobin measurement. o Liquid valve manifold assembly and tubing.

- Optical Manifold :

o Liquid valve manifold assembly and tubing.

- Optical bench :

o Optical bench (patented) with his flow cell (patented).

REF : M22/UM/EN/006

2. GENERAL OVERVIEW

MYTHIC 22

Page 23/99

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

- In the case of replacement of the main power wire supplied with the MYTHIC 22 the new one must comply with the local regulation.

- The MYTHIC 22 has been certified with the power supply box provided with the machine.

- The use of another external power supply box is not guaranteed. Please contact your Orphée’s representative.

Switch on/off

2.3.3 Mono electronic board

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

- Sample needle, rocker, syringe block motors.

- Display and keyboard.

- Connexion mode (RS232, Ethernet, …).

- Printer.

- Measurement (Counting, hemoglobin measurement).

- Data processing.

- External barcode reader.

2.3.4 Power Supply Block

MYTHIC 22 is supplied with an external power supply block.

2. GENERAL OVERVIEW

REF : M22/UM/EN/006

Page 24/99

MYTHIC 22

2.3.5 Reagent tray

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

REF : M22/UM/EN/006

3. INSTRUMENT SET UP

MYTHIC 22

Page 25/99

3. INSTRUMENT SET UP

3.1 USER’S IDENTIFICATION

3.1.1 Start Up

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

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

- Either the identification is yours, press and enter your

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

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

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

- Enter your identification name with the alphabetic keyboard.

- Place the cursor in the Password window.

- Enter your password for identification.

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

- Biologist Password can be modified in section 3.3.6.

o User : No password o Biologist : Password by default 1- 2- 3 o Service people

3.1.2 In process

- To change operator during the process, press to return to the

main menu, and then press on

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

3. INSTRUMENT SET UP

REF : M22/UM/EN/006

Page 26/99

MYTHIC 22

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

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

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

3.2 SYSTEM STATUS

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

- Different system status information is displayed.

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

- To return to the MAIN MENU press

REF : M22/UM/EN/006

3. INSTRUMENT SET UP

MYTHIC 22

Page 27/99

3.3 SET UP

- From the MAIN MENU press on

- This menu is available for all users.

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

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

Language combo box.

- : Select the printer or no printing.

- : Select the paper size depending on the number of results per page.

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

- : If you want to select a new SID number

- : Biologist reserved for complete settings.

(See section 3.4).

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

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

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

- Select the printer and its connection mode.

- Then press

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

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

This prompt appears if the release is done successfully.

3. INSTRUMENT SET UP

REF : M22/UM/EN/006

Page 28/99

MYTHIC 22

Any modification can affect the quality of the results. We

recommend modifying these values only after an Orphée’s

training.

3.4 ADVANCED SET-UP

3.4.1 Printer set up:

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

- Please refer below for the description of each key.

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

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

- To enter a header, press key.

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

3.4.2 Communication:

- Reserved for technical Service people.

- To set up the connection between MYTHIC and Host.

REF : M22/UM/EN/006

3. INSTRUMENT SET UP

MYTHIC 22

Page 29/99

3.4.3 Analysis options:

- OPTIONS box:

o ALWAYS ID and ALWAYS PID: To run a sample, user mandatory

needs to enter a ID and/or a PID.

o RUO: With tag the PCT and PDW parameters are displayed,

printed and send.

o US MODE: The Research Use Only message is printing below the

printing report.

o ABSOLUTE DIF: With tag absolute values for sub-populations of

leucocytes are displayed. In the other case, percentages are displayed.

o QC ALARMS: The message QC_F “QC failed” appear below the

printing report when the QC result is out of tolerance or expired (see section 8.5.5); The message QC_ND “QC not done” appear below the printing report when it is not run (see section 8.5.5).

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

- Barcode Reader box: The reading of the bar code is dedicated to the PID or ID or SID.

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

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

3.4.4 Lab. parameters:

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

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

to adjust the parameters thresholds (see section 3.4.4.2).

to adjust the flags level (see section 3.4.4.3).

to adjust the corrections factors (see section

3.4.4.4).NOTA: No correction factors with type STANDARD.

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

- Press to print the blood type set up.

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

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

3. INSTRUMENT SET UP

REF : M22/UM/EN/006

Page 30/99

MYTHIC 22

3.4.4.1 Limits:

To rename a blood type press then select it

then press to accede at the alphabetic keyboard then press

to validate or to exit without any modification.

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

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

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

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

+ 69 hidden pages

Orphee Mythic 22 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual