Orphee Mythic 18 vet User manual

MYTHIC 18

Page 1/93

ORPHEE

19, chemin du champ-des-filles

CH-1228 Geneva / Plan-les-Ouates

SWITZERLAND

Tel : +41 (0) 22 884 9090

Fax : +41 (0) 22 884 9099

http://www.orphee-medical.com

Mythic™

Vet

Operator’s

Manual

REF : M18Vet/UM-EN/001

Page 2/93

MYTHIC 18

REF : M18 Vet/UM-EN/001

MYTHIC 18

Page 3/93

REVISIONS

Revision Nb

Date

Author

Software

Comments

01/02/2010

PhD

> V 1.0

Creation

CONTACT ADDRESS

MANUFACTURER

Manufactured in France for

ORPHEE SA

19, chemin du champ des filles

CH-1228 Geneva / Plan-les-Ouates

SWITZERLAND

Tel : +41 (0) 22 884 9090

Fax : +41 (0) 22 884 9099

http://www.orphee-medical.com

LOCAL AGENT

REF : M18Vet/UM-EN/001

Page 4/93

MYTHIC 18

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.

NOTA

Indicates important additional information

DANGER

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

Check that the voltage setting matches the supply voltage.

Protective earthing is required; plug the MYTHIC 18 VET into a supply outlet which has an earth connection.

Preserve a good access to the supply outlet to be able to unplug the MYTHIC 18 VET 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 18 VET 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 18 VET

Do not use the MYTHIC 18 VET where aerosol sprays are being used, or where oxygen is being administered.

Do not use the MYTHIC 18 VET out of doors

Always switch off the MYTHIC 18 VET and disconnect the power adaptor before dismantling any part.

The MYTHIC 18 VET is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories by an

authorized people.

- Only Veterinary 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 18 VET are potentially infective. Wearing

rubber gloves is highly recommended and after completion of work, washes 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 a hydraulic cycle is in

progress for it would lead to an immediate stop. To re-start, shut the door and run a Control cycle (see section 9.3.1)

KEEP THESE INSTRUCTIONS

REF : M18 Vet/UM-EN/001

MYTHIC 18

Page 5/93

This equipment needs special precautions regarding EMC and needs to be installed and put

into service according to the EMC information listed below.

Guidance and manufacturer’s declaration – Electromagnetic immunity

The MYTHIC 18 VET is intended for use in the electromagnetic environment specified below. The customer

or the user of the MYTHIC 18 VET should assure that it is used in such 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 18 VET,

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√

Radiated RF

IEC 61000-4-3

3 Vrms

80Mhz to 2,5Ghz

3 Vrms

= 1,2√

80MHz to 800MHz

= 2,3√

800MHz to 2,5GHz

Where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter

manufacturer and d is the recommended separation

distance in meters (m).

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey,ashould be

less than the compliance level in each frequency range

Interference may occur in the vicinity of equipment

marked with the following symbol:

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

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

structures, objects and people.

aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,

amateur radio, AM an FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the

electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should considered. If the measured field

strength in the location in which the MYTHIC 18 VET is used exceeds the applicable RF compliance level above, the MYTHIC 18 VET

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 18 VET.

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

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.

REF : M18Vet/UM-EN/001

Page 6/93

MYTHIC 18

KONFORMITÄTSERKLÄRUNG /

DECLARATION DE CONFORMITE

DECLARATION OF CONFORMITY /

DICHIARAZIONE DI CONFORMITA

Name und Adresse der Firma

Nom et adresse de l’entreprise

Nome e indirizzo della ditta

Name and address of the firm

Orphée S.A.

19 Chemin du Champ des Filles

1228 Plan Les Ouates

Wir erklären in alleiniger Verantwortung, dass

Nous déclarons sous notre propre responsabilité que

Dichiariamo sotto nostra responsabilità che

We declare under our sole responsibility that

das Medizinprodukt für die In-vitro-Diagnostik

le dispositif médical de diagnostic in vitro

il dispositivo medico-diagnostico in vitro

the in vitro diagnostic medical device

Mythic 18 Vet

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

avec la classification selon la directive relative aux dispositifs médicaux de diagnostic in vitro 98/79/CE

con la classificazione secondo la direttiva relativa ai dispositivi medico-diagnostici in vitro 98/79/CE

classified as follows according to the directive on in vitro diagnostic medical devices 98/79/EC

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

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

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

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

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

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

Dispositivo per test autodiagnostico non elencato nell’allegato II /

Device for self-testing not listed in Annex II

Sonstiges Produkt / Autre dispositif / Altro dispostivo / Other device

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

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

qui le concernent.

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

riguardano.

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

REF : M18 Vet/UM-EN/001

MYTHIC 18

Page 7/93

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

Annex III

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 2009

Name und Funktion / Nom et fonction /Nome e

funzione / Name and function

Philippe Daire

RA & QA

REF : M18Vet/UM-EN/001

Page 8/93

MYTHIC 18

TABLE OF CONTENTS

1. INSTALLATION 10

1.1 UNPACKING .........................................................................................................................................................................................10

1.1.1 Introduction..................................................................................................................................................................................................10

1.1.2 Unpacking Procedure ..................................................................................................................................................................................10

1.1.3 Visual checking..............................................................................................................................................................................................11

1.2 INSTALLATION CONSTRAINTS ..........................................................................................................................................................11

1.2.1 Installation place .........................................................................................................................................................................................11

1.2.2 Installation environment ...........................................................................................................................................................................11

1.3 ELECTRICAL CONNECTIONS ...............................................................................................................................................................12

1.3.1 Power supply block ......................................................................................................................................................................................12

1.4 PRINTER CONNECTION.......................................................................................................................................................................12

1.5 CONNECTION,CHANGE AND PRIMING REAGENTS .............................................................................................................................13

1.5.1 Connection.....................................................................................................................................................................................................13

1.5.2 Priming...........................................................................................................................................................................................................14

1.6 TRANSPORTATION AND STORAGE .....................................................................................................................................................16

2. GENERAL OVERVIEW 17

2.1 GENERALITIES ...................................................................................................................................................................................17

2.2 OVERVIEW .........................................................................................................................................................................................18

2.3 MAIN PART DESCRIPTION .................................................................................................................................................................19

2.3.1 Display / Keyboard .....................................................................................................................................................................................19

2.3.2 Dilution hydraulic part..............................................................................................................................................................................21

2.3.3 Mono electronic board .............................................................................................................................................................................22

2.3.4 Power Supply Block ...................................................................................................................................................................................22

2.3.5 Reagent tray...............................................................................................................................................................................................23

3. INSTRUMENT SET UP 24

3.1 USER’S IDENTIFICATION .................................................................................................................................................................24

3.1.1 Start Up........................................................................................................................................................................................................24

3.1.2 In process ....................................................................................................................................................................................................24

3.2 SYSTEM STATUS ...............................................................................................................................................................................25

3.3 SET UP ...............................................................................................................................................................................................26

3.4 ADVANCED SET-UP ............................................................................................................................................................................27

3.4.1 Printer set up:.............................................................................................................................................................................................27

3.4.2 Communication:...........................................................................................................................................................................................27

3.4.3 Analysis options: ........................................................................................................................................................................................28

3.4.4 Lab. parameters:........................................................................................................................................................................................28

3.4.5 Calibration factor: ....................................................................................................................................................................................32

3.4.6 Other Setting: ...........................................................................................................................................................................................32

3.4.7 Storage options: ........................................................................................................................................................................................33

3.4.8 Version release: .........................................................................................................................................................................................34

4. SPECIFICATIONS 35

4.1 ANALYTICAL SPECIFICATIONS.........................................................................................................................................................35

4.2 PHYSICAL SPECIFICATIONS .............................................................................................................................................................39

4.3 REAGENTS SPECIFICATIONS............................................................................................................................................................41

4.3.1 Diluent ...........................................................................................................................................................................................................41

4.3.2 Lysis reagent...............................................................................................................................................................................................41

4.3.3 Cleaning solution ........................................................................................................................................................................................42

4.4 ANALYTICAL LIMITATIONS..............................................................................................................................................................43

4.3.1 Recommendations.......................................................................................................................................................................................43

4.3.1 Interferences.............................................................................................................................................................................................43

5. SAMPLE ANALYSIS 44

5.1 VERIFICATIONS BEFORE STARTING .................................................................................................................................................44

5.2 START UP...........................................................................................................................................................................................44

5.3 REAGENT REPLACEMENT....................................................................................................................................................................45

5.4 START UP RINSING ...........................................................................................................................................................................46

5.5 PREPARATIONS BEFORE ANALYSIS...................................................................................................................................................46

5.6 ANALYSIS .........................................................................................................................................................................................46

5.6.1 Introduction................................................................................................................................................................................................46

5.6.2 Sample Identification ..............................................................................................................................................................................47

5.6.3 Sample run...................................................................................................................................................................................................49

REF : M18 Vet/UM-EN/001

MYTHIC 18

Page 9/93

5.7 RESULTS............................................................................................................................................................................................49

5.8 PRINTING...........................................................................................................................................................................................51

5.8.1 Model report (A4) – external printer....................................................................................................................................................51

5.8.2 Model report – Ticket printer ................................................................................................................................................................51

5.9 LOGS..................................................................................................................................................................................................52

5.10 ARCHIVE ..........................................................................................................................................................................................52

5.10.1 Results ........................................................................................................................................................................................................53

5.10.2 View.............................................................................................................................................................................................................54

5.11 STAND BY AND SHUT DOWN............................................................................................................................................................55

6. QUALITY CONTROL 56

6.1 INTRODUCTION .................................................................................................................................................................................56

6.2 QC.....................................................................................................................................................................................................56

6.2.1 Change...........................................................................................................................................................................................................58

6.2.2 Run control blood.......................................................................................................................................................................................59

6.2.3 Levey-Jennings graph...............................................................................................................................................................................60

6.2.4 Restore ........................................................................................................................................................................................................60

6.3 REPEATABILITY.................................................................................................................................................................................60

7. CALIBRATION 62

7.1 RESULTS.............................................................................................................................................................................................64

7.1.1 Calibration blood analysis .........................................................................................................................................................................64

7.1.2 Calibration....................................................................................................................................................................................................65

7.2 TARGET VALUE MODIFICATIONS ......................................................................................................................................................65

8. TECHNOLOGY 66

8.1 DETECTION PRINCIPLE ......................................................................................................................................................................66

8.1.1 WBC, RBC, PLT Counting ...........................................................................................................................................................................66

8.1.2 Hemoglobin measurement ........................................................................................................................................................................67

8.2 LEUCOCYTE ANALYSIS ......................................................................................................................................................................67

8.3 ERYTHROCYTE ANALYSIS..................................................................................................................................................................68

8.4 ANALYSIS OF PLATELETS .................................................................................................................................................................69

8.5 ALARMS .............................................................................................................................................................................................69

8.5.1 General Flags...............................................................................................................................................................................................69

8.5.2 Leukocytes Flags .......................................................................................................................................................................................70

8.5.3 Erythrocyte and HGB Flags ....................................................................................................................................................................70

8.5.4 Platelet Flags..............................................................................................................................................................................................70

8.5.5 Machine Flags.............................................................................................................................................................................................70

8.6 HYDRAULIC DESCRIPTION .................................................................................................................................................................71

8.6.1 Sampling module..........................................................................................................................................................................................71

8.6.2 Counting bath module................................................................................................................................................................................71

8.6.3 Syringes module .........................................................................................................................................................................................71

8.7 SOFTWARE ........................................................................................................................................................................................72

8.8.1 Windows .......................................................................................................................................................................................................72

9. SERVICE 73

9.1 MAINTENANCE ..................................................................................................................................................................................73

9.1.1 Maintenance table ......................................................................................................................................................................................73

9.1.2 Concentrate cleaning.................................................................................................................................................................................73

9.1.3 Piston greasing............................................................................................................................................................................................76

9.2 HYDRAULIC CYCLES ...........................................................................................................................................................................77

9.3 MECHANICS.......................................................................................................................................................................................78

9.4 REPAIRING ........................................................................................................................................................................................79

9.4.1 Emergency stop ..........................................................................................................................................................................................79

9.4.2 Needle or o-ring replacement ................................................................................................................................................................80

9.4.3 Baths dismantling ......................................................................................................................................................................................82

9.4.4 Baths o-ring replacement ........................................................................................................................................................................85

9.4.5 Aperture block replacement...................................................................................................................................................................85

9.5 TROUBLESHOOTING..........................................................................................................................................................................87

9.5.1 Analytical problems ...................................................................................................................................................................................87

9.5.2 Other problems..........................................................................................................................................................................................88

9.6 TROUBLESHOOTING MESSAGE .........................................................................................................................................................88

9.7 LOGS ERRORS .....................................................................................................................................................................................91

9.8 HYDRAULIC DIAGRAM .......................................................................................................................................................................92

REF : M18 Vet/UM-EN/001

1. INSTALLATION

MYTHIC 18

Page 10/93

1. INSTALLATION

1.1 UNPACKING

1.1.1 Introduction

The MYTHIC 18 VET is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories

by an authorized people.

- Only Veterinary 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.

If the MYTHIC 18 VET has been stored at a temperature less than 10°C, it must stay at

room temperature during 24 hours before switching it on.

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 18 VET from the box.

Starter kit contents:

INSTALLATION KIT

QTY

Designation

Part Number

M18 - WASTE

005-1001-90 24

70W switching adapter

050-1001-01 70 24

European Power line cord

150-2001-CEE C13 1000

M18 Vet User manual

605-1201-02

Screwdriver Slot 1/4"

700-7101-02

MAINTENANCE KIT

QTY

Designation

Part Number

Tygon tubing L=1000mm 1.52x3.2mm

005-1001-90 016 032

Tygon tubing L=500mm 2.06x4mm

005-1001-90 020 040

Tubing 9

005-1001-90 09

Tubing 10

005-1001-90 10

Cables Ties

153-0101-100 25

O-ring Ø13.1x1.6 Fluocarbon 80SH

312-0505-1310 160

O-ring Ø1.4x1.25 Fluocarbon 80SH

312-0505-140 125 010

O-ring Ø5x1 Fluocarbon 80SH

312-0505-500 100

Silicon grease (3gr)

410-0501-02 02

Short Arm TORX T10 Tool

700-1101-10

Short Arm TORX T20 Tool

700-1101-20

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