Orphee Mystic 18 Service manual

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

ORPHEE

MYTHIC 18

SSEERRVVIICCEE MMAANNUUAALL

REF : M18-SM-001 Rev 02

REVISIONS

Revision Nb Date Author Software Comments

01 19/07/04 HC V 0.6x Creation

02 28/02/05 HC V 1.0X Update of all parts

CONTACT ADDRESS

LOCAL REPRESENTATIVE

MANUFACTURER

AUTHORIZED REPRESENTATIVE

WORLDWIDE

C2 Diagnostics

2214, Bd de la Lironde 34397 Montpellier Cedex 5 FRANCE

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

REF : M18-SM-001 Rev 02

IMPORTANT SAFETY INSTRUCTIONS

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.

BEFORE TO INSTALL OR TO MAINTAIN A MYTHIC 18 YOU HAVE TO READ AND TO REFER TO THE USER’S MANUAL.

OPERATORS MUST HAVE RECEIVED ADEQUATE TRAINING.

BE CAREFUL WITH THE EDGE OF THE METAL SHEETS AFTER HAVING DISMANTLED THE COVERS.

REF : M18-SM-001 Rev 02

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 is intended for use in the electromagnetic environment specified below. The customer or the user of the MYTHIC 18 should assure that it is used in such environment.

Immunity test IEC 60601 test level Compliance

level

Recommended separation distance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

Where P is the maximum output power rating of the

Field strenghts from fixed RF transmitters, as

Interference may occur in the vicinity of equipment

3 Vrms 150Khz to 80Mhz

3 Vrms 80Mhz to 2,5Ghz

3 Vrms

Electromagnetic environment - guidance

Portable and mobile RF communications equipment should be used no closer to any part of the MYTHIC 18, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

= 1,2√P

= 1,2√P 80MHz to 800MHz

= 2,3√P 800MHz to 2,5GHz

transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

determined by an electromagnetic site survey, less than the compliance level in each frequency range.

marked with the following symbol:

should be

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

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

Field strenghts 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 strenght in the location in which the MYTHIC 18 is used exceeds the applicable RF compliance level above, the MYTHIC 18 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.

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

REF : M18-SM-001 Rev 02

TABLE OF CONTENTS

1. INTRODUCTION 8

2. FLUIDICS 9

2.1 GENERALITIES ...................................................................................................................................................................................... 9

2.2 FLUIDICS SEQUENCES DESCRIPTION :................................................................................................................................................ 9

2.3 FLUIDICS VIEW ...................................................................................................................................................................................11

2.4 FLUIDICS PARTS DESCRIPTION.......................................................................................................................................................... 12

2.4.1 Sampling module .....................................................................................................................................................................12

2.4.2 Counting bath module ...........................................................................................................................................................12

2.4.3 Syringes module..................................................................................................................................................................... 12

2.5 FLUIDICS DIAGRAM............................................................................................................................................................................ 13

2.5.1 General Diagram .....................................................................................................................................................................13

2.5.2 Manifold tubing position...................................................................................................................................................... 14

2.6 SIZE & LENGTH TUBING ..................................................................................................................................................................... 15

3. ELECTRIC & ELECTRONIC 16

3.1 GENERALITIES .................................................................................................................................................................................... 16

3.2 ELECTRICS PARTS VIEW ..................................................................................................................................................................... 16

3.2.1 Main board ...............................................................................................................................................................................16

3.2.2 GUI board................................................................................................................................................................................ 17

3.2.3 Preamplifier board ................................................................................................................................................................17

3.2.4 Power supply block................................................................................................................................................................. 17

3.3 ELECTRONIC DIAGRAM ....................................................................................................................................................................... 18

3.4 WIRING DIAGRAM .............................................................................................................................................................................. 19

3.4.1 General view............................................................................................................................................................................. 19

3.4.2 Stepper motor........................................................................................................................................................................20

3.4.3 Rocker optical sensor ........................................................................................................................................................... 21

3.4.4 Syringe optical sensor..........................................................................................................................................................22

3.4.5 Needle optical sensor...........................................................................................................................................................23

3.4.6 Syringe valve cable................................................................................................................................................................24

3.4.7 Counting valve cable..............................................................................................................................................................25

3.4.8 Start key switch....................................................................................................................................................................26

3.4.9 Fluidic door switch................................................................................................................................................................27

3.4.10 Temperature sensor............................................................................................................................................................28

4. SPECIFICATIONS 29

4.1 ANALYTICAL SPECIFICATIONS ..........................................................................................................................................................29

4.2 REAGENTS SPECIFICATIONS ............................................................................................................................................................29

4.3 LIMITATIONS.....................................................................................................................................................................................29

5. OUTPUT FORMAT 30

5.2 C2 FORMAT .........................................................................................................................................................................................30

5.2.1 General principle.....................................................................................................................................................................30

5.2.2 FRAMES...................................................................................................................................................................................30

5.2.2.1 REQUEST TO SEND RESULTS.............................................................................................................................. 30

5.2.2.1.1 Request to send results..................................................................................................................................... 30

5.2.2.1.2 ACKNOWLEDGEMENT REQUEST TO SEND RESULTS............................................................................................... 30

5.2.2.1.3 ACKNOWLEDGEMENT RESULTS............................................................................................................................... 30

5.2.2.2 ROUTINE RESULTS ..................................................................................................................................................31

5.2.2.2.1 Alarm list.............................................................................................................................................................. 32

5.2.2.2.2 WBC pathologic alarms..................................................................................................................................... 32

5.2.2.2.3 RBC pathologic messages ................................................................................................................................. 33

5.2.2.2.4 PLT pathologic messages.................................................................................................................................. 33

5.2.2.3 CALIBRATION ........................................................................................................................................................... 33

5.2.2.3.1 Results................................................................................................................................................................... 34

5.2.2.4 QC................................................................................................................................................................................... 34

5.2.2.4.1 Results................................................................................................................................................................... 34

5.2.2.5 REPEATABILITY........................................................................................................................................................ 35

REF : M18-SM-001 Rev 02

5.2.2.5.1 Results................................................................................................................................................................... 35

5.2.3 CHECKSUM .............................................................................................................................................................................35

6. PARTS LIST & BLOW UP VIEW 37

6.1 PARTS LIST..........................................................................................................................................................................................37

6.1.2 Two years spare parts kit....................................................................................................................................................37

6.1.2 Maintenance kit ......................................................................................................................................................................37

6.1.2 O-rings kit................................................................................................................................................................................38

6.1.2 Tubing kit .................................................................................................................................................................................38

6.1.2 All spare parts ........................................................................................................................................................................39

6.2 BLOW UP VIEW.................................................................................................................................................................................... 41

6.2.1 Counting Module ..................................................................................................................................................................... 41

6.2.2 Sampling Module ....................................................................................................................................................................42

6.2.3 Syringe Module ......................................................................................................................................................................43

6.2.4 CPU-PREAMPLIFIER Module..............................................................................................................................................46

6.2.5 Front cover Module...............................................................................................................................................................47

7. SOFTWARE 48

7.1 INTRODUCTION...................................................................................................................................................................................48

7.2 SPECIFIC TECHNICIAN DISPLAY ........................................................................................................................................................48

7.2.1 Technician password..............................................................................................................................................................48

7.2.2 Technician display .................................................................................................................................................................48

7.2.2.1 Technician ..................................................................................................................................................................... 48

7.2.2.2 Counting parameters.................................................................................................................................................. 49

7.2.2.3 Prod. adjust.................................................................................................................................................................. 49

7.2 SOFTWARE ARBORESCENCE................................................................................................................................................................50

8. MAINTENANCE 51

8.1 MAINTENANCE TABLE......................................................................................................................................................................... 51

8.2 CONCENTRATED CLEANING ................................................................................................................................................................52

8.3 CLEAN OUT..........................................................................................................................................................................................53

9. REPAIRING 54

9.1 EMERGENCY STOP ................................................................................................................................................................................54

9.2 SAMPLING MODULE.............................................................................................................................................................................54

9.2.1 Needle replacement...............................................................................................................................................................54

9.2.2 Complete rocker module replacement..............................................................................................................................54

9.3 COUNTING BATHS MODULE................................................................................................................................................................56

9.3.1 Baths dismantling...................................................................................................................................................................56

9.3.2 Baths o-ring replacement....................................................................................................................................................56

9.3.3 Aperture block replacement...............................................................................................................................................56

9.3.4 Complete baths module replacement................................................................................................................................56

9.4 SYRINGE MODULE ...............................................................................................................................................................................57

9.4.1 Piston greasing........................................................................................................................................................................57

9.4.2 O-ring or piston replacement.............................................................................................................................................57

9.4.3 Complete syringe module replacement.............................................................................................................................58

9.5 BOARDS REPLACEMENT.......................................................................................................................................................................59

9.5.1 GUI board replacement........................................................................................................................................................59

9.5.2 Main board replacement ...................................................................................................................................................... 61

9.5.3 Main board...............................................................................................................................................................................63

9.5.3.1 Fuse replacement ........................................................................................................................................................ 63

9.5.3.2 Battery replacement.................................................................................................................................................. 63

9.5.4. Preamplifier board replacement.......................................................................................................................................65

10. TROUBLESHOOTING 66

10.1 ANALYTICAL PROBLEMS ....................................................................................................................................................................66

10.2 OTHER PROBLEMS .............................................................................................................................................................................66

10.3 TROUBLESHOOTING MESSAGE.........................................................................................................................................................67

1. INTRODUCTION

BEFORE TO INSTALL OR TO MAINTAIN A MYTHIC 18 YOU HAVE TO READ AND TO REFER TO THE USER’S MANUAL

The following chapters describe the different technical parts of the MYTHIC 18

- Fluidic

- Electric & electronic

- Technical specification

- Output format

- Spare parts list and blowup view

- Maintenance procedure

REF : M18-SM-001 Rev 02

2. FLUIDICS

2.1 GENERALITIES

MYTHIC 18 is a fully automated analyzer performing hematological analysis on whole blood. The human blood venous sample must be collected in an EDTA K3 (Ethylene Diamine Tetracetic Acid, tri potassic) tube in sufficient quantity. The LMG results are available for six hours after the blood draw. The use of EDTA K2 leads to a poor quality level of the LMG results. It must be correctly homogenized before analysis. It is recommended to use a rotary agitator turning between 20 to 30 turns/mn during 10 minutes.

A volume of insufficient blood for the quantity of anticoagulant or a bad mixing may involve an erroneous result.

Two dilution rate are performed : ~1/237 to 1/257 for WBC/HB (depend of the lysis quantity, see section 7.2.2.2) ~1/15000 for RBC/PLT

2.2 FLUIDICS SEQUENCES DESCRIPTION :

SAMPLING SEQUENCE : 1- Syringes down : (no valve) ~Less than 9,8 µl of blood sample are draw inside the sampling needle Diluent prime Vacuum prime 2- Needle up and syringe up (valve 3+4) Needle outside cleaning with diluent and waste vacuum 3-Rocker move above the WBC bath and the syringes up to drain the waste (valve 7) 4- Needle down to the rinsing position 5- Syringe down WBC bath drain (valve 1) 6- Syringe up Second outside needle cleaning (valve 4) Waste syringe drain (valve 7) 7- Syringe down WBC bath drain (valve 1) 8- Syringe up Waste syringe drain (valve 7)

WBC DILUTION : 9- Needle down to the dilution position and the syringes down to prime the diluent (valve 8) 10- Syringe up for the WBC dilution (~2 ml) Diluent outside of the needle (valve 4) Diluent inside the needle (valve 4+5) Bubble to mix the dilution (valve 1)

RBC DILUTION AND LYSING : 11- Syringe down (no valve) Drawing sample of the first dilution (~20µl)

2. FLUIDICS

Diluent prime Vacuum prime 12- Needle up and syringe up Rocker move above the RBC bath Needle outside cleaning with diluent and waste vacuum (valve 3+4) 13- Needle down to the rinsing position 14 Syringe up Second outside needle cleaning (valve 4+8) Lysis in the WBC bath (0,3 to 0,5ml) (valve 9) Bubble to mix the dilution (valve 1) 15 Syringe down RBC bath drain (valve 2) 16- Needle down to the dilution position 17- Syringe up for the RBC dilution (~1,5ml) Waste syringe drain (valve 7) Diluent outside of the needle (valve 4+8) Diluent inside the needle (valve 5) Bubble to mix the dilution and diluent to rinse the counting head (valve 6+10+2)

MEASUREMENTS : 18- Syringe down to process the vacuum counting (valve 10) 19- First measurement sequences (valve 10) 20- Syringe up Diluent back pressure (valve 4+6) 21- Syringe down to perform the vacuum counting (valve 10) 22- Second measurement sequences (valve 10)

DRAIN AND RINSE BATH : 22- Syringe down Cleaning the apertures (valve 11) WBC bath drain (valve 1) RBC bath drain (valve 2) 23- Syringe up RBC bath rinse diluent (valve 4) Waste syringe drain (valve 7) 24- Needle up and syringes up for back flush (valve 4+6) 25- Rocker move above the WBC bath 26- Syringe up WBC bath rinse diluent (valve 4) Waste syringe drain (valve 7)

NEEDLE BACK AND WASTE DRAIN : 27- Syringe down Dry the outside of the needle (valve 3) 28- Rocker move in the sampling position 26- Syringe up Waste syringe drain (valve 7) 30- Needle down in sampling position

The MYTHIC 18 is ready to perform a new analyze.

REF : M18-SM-001 Rev 02

2. FLUIDICS

2.3 FLUIDICS VIEW

All the fluidics part is on the right side of the instrument and consists of only three 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.

Sampling module

Syringe Module

Counting module

2. FLUIDICS

REF : M18-SM-001 Rev 02

2.4 FLUIDICS PARTS DESCRIPTION

The hydraulic part of the MYTHIC 18 is very simple and made of only three modules :

- Sampling module.

- Counting bath module.

- Syringes module.

The modules are connected together by semi rigid tubing.

2.4.1 Sampling module

This module (patent pending) enables to draw the sample and to perform the WBC and RBC/PLT dilutions. It is assembled with a rotating rocker moving around a support which maintains the system to move up and down the sampling needle. A very reliable system of rack-gear moves the rocker. The cleaning system of the sampling needle can be removed without tool (see section 9.3.2 in the user manual). The o-ring of the needle included in the cleaning system can also be removed without tool (see section 9.3.2 in the user manual). The maintenance of these parts is very easy to perform.

2.4.2 Counting bath module

This module allows to count the WBC and RBC/PLA and to measure the HGB. It is made with a manifold maintaining the reagent commutation valves and the counting bath block with their measurement block including the apertures. The counting bath block assembly and these apertures can be removed without tool (see section 9.3.3/4/5 in the user manual).

2.4.3 Syringes module

This module (patent pending) enables : to draw the sample to distribute the reagents to drain the baths to do the vacuum necessary for counting and to push the waste to the waste container. It is made with a manifold maintaining the fluid commutation valves and with the syringes bloc including five syringes : The sampling syringe The lysis syringe The two waste and vacuum/pressure syringes And the diluent syringe. Only one motor drives the five syringes. The diluent input and the waste output are also included in this manifold.

REF : M18-SM-001 Rev 02

2.5 FLUIDICS DIAGRAM

2.5.1 General Diagram

2. FLUIDICS

2.5.2 Manifold tubing position

Each figure corresponds to a tubing number (see the Fluidic diagram section 2.5.1)

Counting manifold

REF : M18-SM-001 Rev 02

Syringe manifold

Syringe body

REF : M18-SM-001 Rev 02

2. FLUIDICS

2.6 SIZE & LENGTH TUBING

To ensure perfect results it is mandatory to respect the size and the length of the tubing.

Tygon tubing

Part Number REV Designation

005-1001-90 01 01 A Tubing 1-1 820mm 005-1001-90 01 02 A Tubing 1-2 180mm 005-1001-90 02 A Tubing 2 250mm 005-1001-90 03 01 A Tubing 3-1 135mm 005-1001-90 03 02 A Tubing 3-2 20mm 005-1001-90 04 01 A Tubing 4-1 175mm 005-1001-90 04 02 A Tubing 4-2 15mm 005-1001-90 05 A Tubing 5 210mm 005-1001-90 06 A Tubing 6 170mm 005-1001-90 07 B Tubing 7 220mm 005-1001-90 08 A Tubing 8 80mm 005-1001-90 09 B Tubing 9 425mm 005-1001-90 10 01 B Tubing 10-1 8mm 005-1001-90 10 02 A Tubing 10-2 370mm 005-1001-90 11 A Tubing 11 90mm 005-1001-90 12 A Tubing 12 60mm 005-1001-90 13 A Tubing 13 250mm 005-1001-90 14 B Tubing 14 250mm 005-1001-90 15 A Tubing 15 1000mm 005-1001-90 16 A Tubing 16 130mm 005-1001-90 17 A Tubing 17 80mm 005-1001-90 18 A Tubing 18 80mm 005-1001-90 19 A Tubing 19 80mm 005-1001-90 20 A Tubing 20 130mm 005-1001-90 21 B Tubing 21 600mm 005-1001-90 22 A Tubing 22 200mm 005-1001-90 23 A Tubing 23 - DILUENT 1500mm 005-1001-90 24 A Tubing 24 - WASTE 1500mm 005-1001-90 25 A Tubing 25 55mm (45°) 005-1001-90 26 A Tubing 26 5mm 005-1001-90 016 032 005-1001-90 020 040 005-1001-90 030 060

Tygon Tubing L=1000mm

1,6x3.2mm

A Tygon Tubing L=500mm 2x4mm 500mm

A 20L Tubing Straw adaptor 100mm

0,8x2,4mm

1000mm

Tygon tubing

1,3x3mm

Tygon

tubing

1,6x3,2mm

Tygon tubing

2x4mm

Tygon tubing

3x6mm

Tygon tubing

5x8mm

4. SPECIFICATIONS

3. ELECTRIC & ELECTRONIC

3.1 GENERALITIES

Only three boards compose the MYTHIC 18 :

- the main board

- the preamplifier board

- and the GUI board

- In the case of replacement of the main board or preamplifier board, be aware of the sensibility of this board to the electrical static discharge (ESD).

- Before operating check the earth connection and use the antistatic bag supply with the board. Please contact your Orphée for more information.

- Be careful with the edge of the metal sheets after having dismantled the covers.

3.2 ELECTRICS PARTS VIEW

3.2.1 Main board

REF : M18-SM-001 Rev 02

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.

REF : M18-SM-001 Rev 02

3.2.2 GUI board

3.2.3 Preamplifier board

3. ELECTRICS & ELECTRONICS

3.2.4 Power supply block

MYTHIC 18 is supplied with an external power supply block.

- In case of replacement of the main power wire supplied with the MYTHIC 18, the new one must comply with the local regulation.

- The MYTHIC 18 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 Orphée.

3. ELECTRICS & ELECTRONICS

3.3 ELECTRONIC DIAGRAM

REF : M18-SM-001 Rev 02

3.4 WIRING DIAGRAM

3.4.1 General view

3. ELECTRICS & ELECTRONICS

3.4.2 Stepper motor

REF : M18-SM-001 Rev 02

3.4.3 Rocker optical sensor

3. ELECTRICS & ELECTRONICS

+ 47 hidden pages

Orphee Mystic 18 Service manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1. INTRODUCTION

2. FLUIDICS

2.1 GENERALITIES

2.2 FLUIDICS SEQUENCES DESCRIPTION :

2.3 FLUIDICS VIEW

2.4 FLUIDICS PARTS DESCRIPTION

2.4.1 Sampling module

2.4.2 Counting bath module

2.4.3 Syringes module

2.5 FLUIDICS DIAGRAM

2.5.1 General Diagram

2.5.2 Manifold tubing position

2.6 SIZE & LENGTH TUBING

3. ELECTRIC & ELECTRONIC

3.1 GENERALITIES

3.2 ELECTRICS PARTS VIEW

3.2.1 Main board

3.2.2 GUI board

3.2.3 Preamplifier board

3.2.4 Power supply block

3.3 ELECTRONIC DIAGRAM

3.4 WIRING DIAGRAM

3.4.1 General view

3.4.2 Stepper motor

3.4.3 Rocker optical sensor