Convergent Convergys X5 User manual

Convergys
®
X5
Hematology Analyzer
_
User’s Manual
Release 1.6
X5USER20120404
ConvergentTechnologies GmbH & Co. KG
Softwarecenter 1, D -35037 Marburg, Germany
Tel.: [phone]
Fax: [phone]
www.convergent-technologies.de
[email protected]

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
2
This user manual is intended to give detailed information for end users of Convergent Technologies
GmbH & Co. KG Convergys
®
X5 optical hematology analyzer.
All information contained herein is the intellectual property of Convergent Technologies GmbH & Co.
KG and should not be used or reproduced without prior agreement of Convergent Technologies
GmbH & Co. KG, the manufacturer.
This manual was written with the intention to give the most precise and up-to-date, detailed description
of operation and use of the analyzer for laboratory purposes.
Descriptions contained herein are relevant to Convergys
®
X5, software version 1.3.936

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED
OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY
PARTICULAR PURPOSE.
Every Convergys
®
X5 H a e m a t o l o g y A n a l y s e r u n i t is tested thoroughly before delivery to the
customers’ laboratory and is guaranteed for eighteen months from the dated of invoice/delivery
(whatever is earlier) for all manufacturing defects.
The warranty is for all mechanical and electrical parts. It is granted only for a proper installation, use
and maintenance in compliance with the instructions as contained in this User’s Manual.
All parts and consumables that are subject to deterioration, because of their specific use, are excluded
from the warranty.
Exemptions
Convergent Technologies obligation or liability under this warranty does not include any transportation
or other charges or liability for direct, indirect or consequential damages or delay resulting from the
improper use or application of the product or the use of parts or accessories not approved by
Convergent Technologies or repairs by people other than Convergent Technologies authorized
personnel.
This warranty shall not extend to:
•Any Convergent Technologies product which has been subjected to misuse, negligence or
accident.
•any Convergys
®
product from which Convergent Technologies original serial number tag or
product identification markings have been altered or removed.
•Any product of any other manufacturer.
Manufactured by:
Convergent Technologies GmbH & Co. KG
Software Centre 1
D-35037 Marburg, Germany
Tel: [phone]
Fax: [phone]
Homepage: www.convergent-technologies.de
e-mail: [e-mail]

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
4
Table of Contents
1 For Your Safety .............................................................................................................................. 11
1.1 Who Should Use This Manual....................................................................................... 11
1.2 Special Symbols Used In This Manual ........................................................................... 11
1.3 General Precautions .................................................................................................... 11
1. .1 Environmental Factors................................................................................................................... 12
1. .2 Electrical Requirements ................................................................................................................. 12
1. . Space Requirements ...................................................................................................................... 1
1. .4 Weight Requirements .................................................................................................................... 15
1. .5 Waste Disposal............................................................................................................................... 15
1. .6 Known Limitations ......................................................................................................................... 16
1. .7 Emergency Situations .................................................................................................................... 16
2 Support of the Product .................................................................................................................. 17
3 First time use ................................................................................................................................. 18
3.1 What is in the Bo ....................................................................................................... 18
.1.1 The Analyzer Package .................................................................................................................... 18
.1.2 The Autosampler Package ............................................................................................................. 18
.1. Visual inspection before starting the analyzer .............................................................................. 18
4 The Conver ys® X5 ........................................................................................................................ 19
4.1 General Description..................................................................................................... 19
4.1.1 Measured Parameters ................................................................................................................... 19
4.1.2 Reagents and control materials .................................................................................................... 20
4.1. Genuine Convergys
®
Reagents ..................................................................................................... 21
4.2 Measurement principles .............................................................................................. 23
4.2.1 Volumetric Impedance Method..................................................................................................... 2
4.2.2 Principle of HGB Measurement ..................................................................................................... 24
4.2. Principle of Optical Light Scatter and Diffraction Method............................................................. 24
4.3 Identifying the Convergys
®
X5 ...................................................................................... 27
4. .1 Front Panel..................................................................................................................................... 27
4. .2 Rear Panel (electrical connections) ............................................................................................... 28
4. . Left Side Assembly ......................................................................................................................... 29
4. .4 Right Side Assembly....................................................................................................................... 0
With side panel removed .......................................................................................................................... 0
4. .5 Front Assembly .............................................................................................................................. 1
5 User Interface ................................................................................................................................ 32
5.1 Using the Touch Screen................................................................................................ 32
5.2 Using the ‘Start’ Button ............................................................................................... 32
5.3 Using an E ternal Mouse ............................................................................................. 32
5.4 Using an E ternal Keyboard ......................................................................................... 33
5.5 Using the On-Screen Virtual Keypads ........................................................................... 33

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
5
5.6 Using the Graphical User Interface ............................................................................... 35
5.6.1 Quick Links ..................................................................................................................................... 5
5.6.2 The Interactive Display Area .......................................................................................................... 5
5.6. The Status Display.......................................................................................................................... 5
5.6.4 Entering Information ..................................................................................................................... 6
5.7 The Menu System........................................................................................................ 36
5.7.1 Primary Menu Items ...................................................................................................................... 6
5.7.2 Starting a Manual Single Tube Measurement ............................................................................... 6
5.7. Start Automated Measurements ................................................................................................... 7
5.7.4 Access the Database ...................................................................................................................... 7
5.7.5 Initiate Printing .............................................................................................................................. 7
5.7.6 Main Menu .................................................................................................................................... 7
5.7.7 Autosampler Control Panel............................................................................................................ 8
5.7.8 Adjust the Time and Date .............................................................................................................. 8
5.7.9 Open the Warning Panel................................................................................................................ 8
5.7.10 Menu tree ...................................................................................................................................... 8
5.7.11 Safety Access Codes....................................................................................................................... 40
6 Start Up and Shut Down the Conver ys
®
X5 .................................................................................. 41
6.1 Start Up and Shut Down Overview ............................................................................... 41
6.2 Starting Up the Convergys
®
X5 Analyzer........................................................................ 41
6.2.1 Visual Check ................................................................................................................................... 41
6.2.2 Power on– Start up ........................................................................................................................ 41
6.2. Start Up the User Interface............................................................................................................ 42
6.2.4 User Login ...................................................................................................................................... 42
6.2.5 Pneumatic System Start and Blank Measurement ........................................................................ 4
6.3 E iting theConvergys® X5 Analyzer............................................................................... 44
6. .1 Log Off............................................................................................................................................ 44
6. .2 Shut Down ..................................................................................................................................... 44
6. . Prepare for Shipment .................................................................................................................... 45
6. .4 Emergency Shut Down................................................................................................................... 47
6. .5 Repackaging the Convergys
®
X5 Analyzer ...................................................................................... 48
7 Sample Measurement ................................................................................................................... 49
7.1 Sample Types Supported by the Convergys
®
X5............................................................. 49
7.1.1 Supported Sample Tubes Types..................................................................................................... 49
7.1.2 Sampling Depth.............................................................................................................................. 49
7.1. Open or Closed Sample Tubes ....................................................................................................... 50
7.1.4 Sample Collection and Handling .................................................................................................... 50
7.2 Sample Types and Modes ............................................................................................ 51
7.3 Sample Identification................................................................................................... 51
7.4 Running Samples ......................................................................................................... 52
7.4.1 Manual Mode ................................................................................................................................ 52
7.4.2 Automatic Mode ............................................................................................................................ 54
7.5 Result Display.............................................................................................................. 64

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
6
7.6 Printing Reports .......................................................................................................... 64
7.7 The Measurement Process........................................................................................... 64
8 Result Interpretation ..................................................................................................................... 66
8.1 Results ........................................................................................................................ 66
8.2 Sample Identification Information................................................................................ 67
8.3 Parameter Information................................................................................................ 67
8. .1 Scatter Diagrams and Histograms.................................................................................................. 68
8. .2 Warnings........................................................................................................................................ 69
9 Database Functions....................................................................................................................... 75
9.1 Database Overview...................................................................................................... 75
9.2 Scrolling and selection ................................................................................................. 76
9.3 Sorting Database Information ...................................................................................... 76
9.4 Manual Selection of Database Records......................................................................... 77
9.5 Automatic Selection of Database Records .................................................................... 77
9.6 Viewing Detailed Results ............................................................................................. 77
9.7 Statistics...................................................................................................................... 78
9.8 Managing Database Records ........................................................................................ 78
9.8.1 Select By......................................................................................................................................... 78
9.8.2 Importing ....................................................................................................................................... 79
9.8. Export............................................................................................................................................. 80
9.8.4 Send to LIS ..................................................................................................................................... 80
9.8.5 Save Tab File .................................................................................................................................. 80
9.8.6 Save Raw Data ............................................................................................................................... 81
9.8.7 Delete............................................................................................................................................. 81
9.8.8 Calibration...................................................................................................................................... 81
9.9 Calibrating the Convergys
®
X5 ...................................................................................... 82
9.9.1 View Calibrations ........................................................................................................................... 84
10 Quality Control .............................................................................................................................. 86
10.1 Set QC Reference......................................................................................................... 87
10.2 QC Measurement ........................................................................................................ 88
10.3 View QC References..................................................................................................... 88
10.4 View QC Data .............................................................................................................. 88
10.5 View QC Diagrams ....................................................................................................... 88
11 Patients database.......................................................................................................................... 89
12 Settin s.......................................................................................................................................... 91
12.1 Customize Settings ...................................................................................................... 92

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
7
12.2 Laboratory Settings ..................................................................................................... 92
12.3 E ternal Devices .......................................................................................................... 92
12.4 System Settings ........................................................................................................... 93
12.5 Units ........................................................................................................................... 95
12.6 Printer Settings............................................................................................................ 96
12.7 Profile Limits Settings .................................................................................................. 97
12.8 Date and Time Adjustment .......................................................................................... 98
13 Instrument Dia nostics.................................................................................................................. 99
1 .1.1 Self-Test of the Analyzer ................................................................................................................ 99
1 .1.2 Daily Log....................................................................................................................................... 101
1 .1. Reagent Status ............................................................................................................................. 101
1 .1.4 Statistics....................................................................................................................................... 102
1 .1.5 Information.................................................................................................................................. 102
14 Maintenance................................................................................................................................ 103
14.1.1 Opening the Front Panel.............................................................................................................. 10
14.1.2 Closing the Front Panel ................................................................................................................ 10
14.1. Removing the Side Panels............................................................................................................ 104
14.1.4 User Maintainable Parts Of The Analyzer.................................................................................... 104
14.1.5 Maintenance programs in the analyzer....................................................................................... 105
14.1.6 Cleaning the shear valve .............................................................................................................. 106
14.1.7 Cleaning the Washing Head......................................................................................................... 111
14.1.8 Cleaning the Measuring Chambers (Hard Cleaning).................................................................... 112
14.1.9 Daily Cleaning .............................................................................................................................. 112
14.1.10 Special Cleaning Procedure.......................................................................................................... 112
14.1.11 Replacing Reagents...................................................................................................................... 11
14.1.12 Disposal of Reagent Containers ................................................................................................... 114
15 Rea ent Lockin .......................................................................................................................... 115
16 The Daily-Routine ........................................................................................................................ 116
17 Troubleshootin ........................................................................................................................... 118
17.1.1 Software error messages ............................................................................................................. 118
17.1.2 Pneumatic errormessages ........................................................................................................... 119
17.1. Mechanical Problems................................................................................................................... 120
17.1.4 Sample Rotor (SR) Failures........................................................................................................... 120
17.1.5 Needle Mechanics, Vertical Motor (Mvert) Problems................................................................. 121
17.1.6 Shear Valve (SV) Related Errors ................................................................................................... 122
17.1.7 Dilutor Errors ............................................................................................................................... 122
17.1.8 Priming Problems......................................................................................................................... 122
17.1.9 Electronics Related Problems ...................................................................................................... 12
17.1.10 The Analyzer Does Not Power On................................................................................................ 12
17.1.11 I2c Errors Displayed At Startup.................................................................................................... 12
17.2 Measurement results related problems.......................................................................123
17.2.1 Fluctuating PLT background values.............................................................................................. 12
17.2.2 Long, smeared population ........................................................................................................... 12

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
8
18 Accessories .................................................................................................................................. 124
19 Known Problems.......................................................................................................................... 125
20 Appendices .................................................................................................................................. 126
20.1.1 Reagent Consumption ................................................................................................................. 126
20.1.2 Display Range............................................................................................................................... 127
20.1. Fluidic System .............................................................................................................................. 128
20.1.4 Printed Report Formats ............................................................................................................... 129
20.1.5 Specifications ............................................................................................................................... 1
20.1.6 Measured Parameters ................................................................................................................. 1
20.1.7 Technical Data.............................................................................................................................. 1 4
20.1.8 Performance Data........................................................................................................................ 1 6
20.1.9 Reagent System ........................................................................................................................... 1 8
20.1.10 Tab File Format ............................................................................................................................ 1 9
21 Index ............................................................................................................................................ 140
Table of Figures
Figure 1. Convergys
®
X5 with Autosampler Space Requirements....................................................... 14
Figure 2. Convergys
®
X5 without Autosampler Space Requirements................................................. 15
Figure . Volumetric Impedance Method ............................................................................................. 2
Figure 4. Photometric Light Absorbance Method................................................................................. 24
Figure 5. Convergys
®
X5 Optical Head Block Diagram......................................................................... 24
Figure 6. Optical Signal Processing System ........................................................................................... 25
Figure 7. Cellular Light Scatter............................................................................................................... 25
Figure 8. 4DIFF Scatter Diagram............................................................................................................ 26
Figure 9. Left Side Assembly.................................................................................................................. 29
Figure 10. Right Side Assembly ............................................................................................................. 0
Figure 11. Behind the Front Panel......................................................................................................... 1
Figure 12. Alphanumeric Virtual On-Screen Keypad.............................................................................
Figure 1 . ‘Sticky’ Shift and Symbol Buttons......................................................................................... 4
Figure 14. Numeric Virtual On-screen Keypad...................................................................................... 4
Figure 15. Date Virtual On-Screen Keypad............................................................................................ 4
Figure 16. Graphical User Interface Sections ........................................................................................ 5
Figure 17. The Status Display ................................................................................................................ 5
Figure 18. Convergys
®
X5 Main Menu................................................................................................. 8
Figure 19. Log Off .................................................................................................................................. 44
Figure 20. Shut Down ............................................................................................................................ 44
Figure 21. Prepare for Shipment ........................................................................................................... 45
Figure 22. Connect Distilled Water Panel.............................................................................................. 46
Figure 2 . Remove Reagent Tubing Panel............................................................................................. 46
Figure 24 Shut Down Ready Panel ........................................................................................................ 46
Figure 25. Shut Down Ready Panel ....................................................................................................... 47
Figure 26. Sampling Needle................................................................................................................... 50

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
9
Figure 27 Result Screen......................................................................................................................... 5
Figure 28. Autosampler Info and AS Panel............................................................................................ 54
Figure 29. Full Scan Automatic Processing Mode ................................................................................. 56
Figure 0. Full Scan Mode Tray View Progress...................................................................................... 57
Figure 1. Full Scan Mode Tray and List Views ..................................................................................... 58
Figure 2. Free List Mode Selection ...................................................................................................... 59
Figure . +Figure 4. Preparing a Free List.......................................................................................... 60
Figure 4. Free List Mode Progress: List View....................................................................................... 60
Figure 5. Free List Mode Progress: Tray View ..................................................................................... 61
Figure 6. Selected Sample Mode Panel............................................................................................... 62
Figure 7. Control the Autosampler with Info Panel ............................................................................ 6
Figure 8. Results Display and Magnified Scatter Plot.......................................................................... 64
Figure 9. Convergys
®
X5 Measurement Process................................................................................ 65
Figure 40. Convergys
®
X5 Result Screen.............................................................................................. 66
Figure 41. Parameter Information Display........................................................................................... 67
Figure 42. Graphical Normal Range Display.......................................................................................... 67
Figure 4 . Result Screen Scatter Diagrams............................................................................................ 69
Figure 44. Result Screen Histograms..................................................................................................... 69
Figure 45. Warnings Section of Results Screen..................................................................................... 69
Figure 46. Accessing the Database........................................................................................................ 75
Figure 47. Scrolling and Selecting.......................................................................................................... 76
Figure 48. Multi-Select and Multiple-Selection..................................................................................... 77
Figure 49. Manage Records Panel......................................................................................................... 78
Figure 50. Select By Panel ..................................................................................................................... 78
Figure 51. Database Importing Panel.................................................................................................... 79
Figure 52. Directory Panel for Data Storage.......................................................................................... 80
Figure 5 . Calibration Options............................................................................................................... 82
Figure 54. Calibration Panel and Calibration Run Result Panel............................................................. 82
Figure 55. Calibration Factor Panel ....................................................................................................... 84
Figure 56. View Calibration Panel ......................................................................................................... 85
Figure 57. QC Panel ............................................................................................................................... 86
Figure 58. Set QC Reference Panel........................................................................................................ 87
Figure 59. View QC Diagrams Panel ...................................................................................................... 88
Figure 60. Patients Panel....................................................................................................................... 89
Figure 61. Edit Patient Panel ................................................................................................................. 90
Figure 62. Settings Panel ....................................................................................................................... 91
Figure 6 . Customize Settings Panel ..................................................................................................... 92
Figure 64. External Devices Settings Panel............................................................................................ 9
Figure 65. System Settings Panel........................................................................................................... 94
Figure 66. Units Settings Panel.............................................................................................................. 95
Figure 67. Printer Settings Panel ........................................................................................................... 96
Figure 68. Profile Limits Settings Panel ................................................................................................. 97
Figure 69. Time/Date Settings............................................................................................................... 98
Figure 70. Statistics display ................................................................................................................. 102
Figure 71. Information display ............................................................................................................ 102

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
10
Table of Tables
Table 1. Convergys
®
X5 Analyzer Parameters...................................................................................... 20
Table 2. Convergys
®
Dil-Diff (D50) Diluent Information ....................................................................... 21
Table . Convergys
®
Lyse-5P Information............................................................................................. 21
Table 4. Convergys
®
Diff-5P Information.............................................................................................. 22
Table 5. Convergys
®
Hypoclean CC Information................................................................................... 22
Table 6. Convergys
®
X5 Analyzer Menu Tree ...................................................................................... 40
Table 7. Sample Identification Information........................................................................................... 67
Table 8. Normal Range Flags ................................................................................................................. 68
Table 9. Linearity Range Flag................................................................................................................. 68
Table 10. High Blank Flag....................................................................................................................... 68
Table 11. Warning Flags ................................................................................................................... 7
Table 12. Interpretive Flags .............................................................................................................. 74
Table 1 . Database Sort Criteria............................................................................................................ 76
Table 14. Count Unit Parameters.......................................................................................................... 95

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
11
1For Your Safety
1.1 Who Should Use This Manual
This user manual is written for clinical laboratory professionals using the Convergent Technologies
Convergys
®
X5 automated hematology analyzer. The manual includes information about operation and
user interface of the Convergys
®
X5.
It also introduces the steps to perform the setup procedures to tailor the operation to the requirements
of your laboratory.
This description also describes daily routine and maintenance requirements to keep your analyzers
up-time as long as possible.
1.2 Special Symbols Used In This Manual
Label Meaning Explanation
Biohazard
The sample and the waste are potentially infectious
material
Corrosive Reagents may cause corrosion or skin irritation.
Warning General warning of injury.
Sharp needle warning The sampling needle may cause injury.
1.3 eneral Precautions
The analyzer weighs 35kg, please do not attempt to move it alone, the instrument should
always be moved by two persons, holding the analyzers two sides and hold it in a nearly
standing position.
To avoid injury, always kneel down before lifting the unit from lower positions.
For the longer transportation, please, drain the reagents and repackage the Convergys
®
X5.
Make sure to retain packaging material for safe transportation and storage in the future.
In case of inactivity of analyzer or storage, please, drain the reagents and repackage the
Convergys
®
X5. Do not expose the Convergys
®
X5 to direct sun shine or extreme temperature
condition or humidity (>80%)
The analyzer operates with reagents. These are chemical materials; direct (skin) contact
should be avoided. Please read reagent descriptions carefully for possible emergency
actions.

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
12
To ensure reliable operation and reliable results:
•only human blood samples should be analyzed
•only Convergent Technologies supplied reagents should be used
•minimal maintenance actions should be performed on a regular basis
•only Convergent Technologies certified service personnel should perform service actions
•only Convergent Technologies supplied service material and spare parts should be used
The original reagents and service materials and spare parts are available from Convergent
Technologies
Service personnel should participate a Convergys
®
X5 Service Training and pass the service
training examination.
Operators should participate on a Convergys
®
X5 Operator Training. This training is
organized and controlled by a certified service person responsible for the training
Replaced materials, spare parts (tubes, valves, etc.) which might have been in contact with
human blood or any of the reagents should be handled as a potential biologically hazardous
and chemically dangerous material. These materials should be handled observing
applicable law. Convergent Technologies recommends disposal of these components with
burning.
This analyzer contains electronic components. Please handle electronic waste
adhering to local or federal regulations.
1.3.1 Environmental Factors
Convergys
®
X5 is designed for laboratory operation. Mobile operation is not supported.
Operate Convergys
®
X5 within the ambient temperature range of 15-35°C (59-98 °F) and
maximum relative humidity of 80%. The optimum operating temperature is 25°C. Reagents
should be stored at a temperature range of 15-30°C. The Convergys
®
X5 operates properly
up to 3000 meters above sea-level.
Do not place the reagent containers to a higher position than Convergys
®
X5. This is to
avoid unintentional spilling of reagents. The vertical distance between the reagent
container and Convergys
®
X5 must not be more than 120 centimeter
1.3.2 Electrical Requirements
The analyzer should only be operated from a wall outlet meeting general specifications of
power input requirements: 110/220VAC; 47Hz to 63Hz
Power Consumption: maximum 400 VA
If power network is not reliable, contact your representative for options (e.g. installation of
an external UPS module).
Only the power cord supplied with the instrument should be used. Avoid using extension
cords.

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
1
Failure to properly ground the Convergys
®
X5 bypasses important safety features and may
result in electrical hazard.
The instrument should not be placed near potentially interfering devices capable of emitting radio
frequencies (e.g. radio or television transmitters/receivers, radars, centrifuges, X-ray devices, fans,
etc.).
This analyzer is designed to be safe for transient voltages to INSTALLATION CATEGORY II and
POLLUTION DEGREE 2.
1.3.3 Space Requirements
To allow reliable operation and to provide a safe working environment, make sure that the
table supporting the unit is stable enough to carry the weight of the instrument and
necessary accessories (total weight ca. 55 kg). Reagents should be placed below the
supporting desk, or next to the analyzer on the same level, not above the analyzer.
Reagents below the analyzer save desk space.
It is important to install the instrument in a suitable location. A poor location can adversely
affect its performance. Consider the following space requirements:
Select a location near a power source and close to a suitable drain. Place the unit on a clean and level
surface. Leave at least 0.5 m space on both sides and above the instrument to access pneumatics.
Provide a minimum of 0.2 m between the rear panel and the wall to allow for heat dissipation and tube
clearance. Keep clear the place in front of the equipment to be able to open the front panel.

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
14
Use the below sketch to find a suitable location for the analyzer
(the images below shows Convergys
®
X5 with / without its optional Auto Sampler unit):
Figure 1. Convergys
®
X5 with Autosampler Space Requirements

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
15
Figure 2. Convergys
®
X5 without Autosampler Space Requirements
1.3.4 Weight Requirements
The Convergys
®
X5 analyzer weighs 35 Kg without the Autosampler and 47Kg the with optional
Autosampler. Adding an external keyboard, documents etc. can bring the total weight up to 60 Kg. If
you decide to store the reagents on the same surface, then the combined weight can reach 100 Kg.
Please select a table, laboratory shelf, or other location which can support the weight of the
Convergys
®
X5 with accessories and is free from vibration.
To allow reliable operation and to provide a safe working environment, make sure that the
table supporting the unit is stable enough to carry the weight of the instrument and
accessories.
1.3.5 Waste Disposal
Convergys
®
X5 analyzer waste contains human blood and reagents that are chemically and biologically
active, and should be considered to be a potential infection and biohazard threat. Safe laboratory
practices must be followed including the use of personal protective when operating the Convergys
®
X5
and handling blood, reagents, and waste.

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
16
1.3.6 Known Limitations
Convergys
®
X5 analyzer waste contains human blood and reagents that are chemically and biologically
active, and should be considered to be a potential infection and biohazard threat. Safe laboratory
practices must be followed including the use of personal protective when operating the Convergys
®
X5
and handling blood, reagents, and waste.
1.3.7 Emergency Situations
Always follow all applicable laws and regulations with regard to emergency situations.
If the Convergys
®
X5 needs to be powered off due to an emergency situation (like fire, thunderstorm
etc.), follow the procedures in chapter 6.3.4
In case of fire, do not use water to extinguish the fire unless the Convergys
®
X5is
disconnected from the electrical network!

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
17
2Support of the Product
Your sales representative is trained and skilled to answer all application and operation specific
questions. Would you have further inquiries regarding Convergys
®
X5, feel free to ask for support
directly from the manufacturer through your sales representative.
Convergent Technologies makes all efforts to provide maximum support and up to date information
and services regarding Convergys
®
X5. Software updates and application documents are continuously
made available for Convergent Technologies representatives and partners.
Manufactured by:
Convergent Technologies GmbH & Co. KG
Software Centre 1
D-35037 Marburg, Germany
Tel: [phone]
Fax: [phone]
Homepage: www.convergent-technologies.de
e-mail: [e-mail]

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
18
3First time use
Convergys
®
X5 is a complex measuring device. As such, there are some precautions you must take
before turning the analyzer on. First of all, you should read this manual, especially this chapter.
3.1 What is in the Box
3.1.1 The Analyzer Package
After opening the packaging, you will find an accessory box. The analyzer is in a plastic bag in
between cushioning protective material. After opening the bag, remove the silicone desiccants.
•Accessories box on top of the analyzer, including:
a. Power cord
b. User Manual (this document)
c. Sample adapter for the sample unit (1 pcs)
d. Reagent tube kit (in a plastic bag, with special caps)
e. Plastic waste container
•Maintenance kit
a. “Preparing for shipment” tube kit
•Convergys
®
X5 Analyzer
a. Convergys
®
X5 Analyzer final check report
b. The Convergys
®
X5 Analyzer
Would any of the above be missing, please inform your Sales Representative.
3.1.2 The Autosampler Package
The Autosampler is an optional unit that attaches to theConvergys
®
X5. If the optional Autosampler unit
was ordered, package should contain the following items:
•Auto-Sampler unit
•A sample tray
•10 pieces sample racks
•Auto Sampler final check report
Please inform your sales representative if any item is missing or damaged. Retain the original
Autosampler packaging for future transportation and storage.
3.1.3 Visual inspection before starting the analyzer
To ensure correct operation, and to check that the instrument has been delivered to you without any
damage, please check the following before starting the unit for the first time:
•the front panel should have no cracks
•the screen should have no cracks
•no visible dents or bumps on instrument housing (front, side rear, top cover)
•open the front panel of the unit
a. the front panel is easy to open and close (see section 10.1)
b.
inspect that the syringes are not cracked

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
19
4The Convergys® X5
4.1 eneral Description
The Convergys
®
X5 is a fully automated high quality hematology analyzer for in vitro diagnostic use in
clinical laboratories. It provides precise and accurate 5-part differential measurement using a laser
based optical measurement technology.
The Convergys
®
X5 Analyzer uses the Coulter method for measurement of leukocytes (WBC),
erythrocytes (RBC) and platelet (PLT) concentrations. Measurement of the hemoglobin (HGB) content
of red blood cells is accomplished by photometric measurement technology. Five part leukocyte
differentiation (LYM%, MON%, NEU%, EOS%, BAS%) is accomplished using optical laser-based flow
cytometric technology.
A vivid color touch screen display is featured with an intuitive, informative, and attractive user
interface. A START button allows one-touch operation for ease of use.
The Convergys
®
X5 Analyzer’s unique software system supports the use of many commonly used
external printers with its USB connections. The Convergys
®
X5 internal database is capable of storing
100,000 patients, QC, and calibration result records including flags and graphical scatter diagrams
and histograms. The system software is field-upgradeable to ensure up-to-date operation.
An automatic optional Autosampler is available (sold separately) for automatically processing up to
100 sample tubes for increased laboratory efficiency. The system software supports a variety of
flexible LIS download techniques for efficient integration into laboratory workflow.
The Convergys
®
X5 features advanced Ethernet LIS connectivity using the HL7 protocol in addition to
standard serial interfaces, providing the clinical laboratory with flexible connectivity options.
4.1.1 Measured Parameters
Convergys
®
X5 determines 24 hematology parameters including 5-part WBC differential. The
instrument requires 100 µ l of whole blood-sample in Closed- and Open-mode. Cycle time is 60
seconds.
Parameter Symbol Measurement method
White Blood Cell count WBC Impedance measurement
Lymphocyte count LYM Calculated
Monocyte count MON Calculated
Neutrophil count NEU Calculated
Eosinophil count EOS Calculated
Basophil count BAS Calculated
Lymphocyte percentage LYM% Optical measurement
Monocyte percentage MON% Optical measurement
Neutrophil percentage NEU% Optical measurement
Eosinophil percentage EOS% Optical measurement
Basophil percentage BAS% Optical measurement
Red Blood Cell count RBC Impedance measurement
Hemoglobin HGB Photometric measurement
Hematocrit HCT Calculated
Mean Corpuscular Volume MCV Derived
Mean Corpuscular Hemoglobin MCH Calculated
Mean Corpuscular Hemoglobin
Concentration
MCHC Calculated
Red Blood cells Distribution Width RDWcv Derived
Red Blood cells Distribution Width RDWsd Derived

Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual
20
Parameter Symbol Measurement method
Platelet count PLT Impedance measurement
Mean Platelet Volume MPV Derived
Platelet Distribution Width**
(for Research Use Only)
PDWcv Derived
Platelet Distribution Width**
(for Research Use Only)
PDWsd Derived
Thrombocrit**
(for Research Use Only)
PCT Calculated
**The PDWcv, PDWsd, and PCT parameters are considered to be for Research Use Only
(RUO), and will be marked on the screen, printout, database, and LIS transmission.
Table 1. Convergys
®
X5 Analyzer Parameters
4.1.2 Reagents and control materials
Always use reagents and control materials recommended and approved by the manufacturer. The
analyzer, the control material and the reagents form a system. Each component of this system is
carefully selected and designed to meet certain criteria, which can very sensitively indicate and
validate system operation.
Using non-approved components of this system can cause false indications or incorrect, inaccurate
measurements.
The analyzer operates with reagents. These are chemical materials; direct (skin)
contact should be avoided. Before installation of reagents, please read reagent
specifications carefully for possible emergency actions. Only original reagents are
usable withConvergys
®
X5 available from Convergent Technologies.
Place the reagent containers near the instrument, to an accessible location.
Do not place the containers to a higher position than Convergys
®
X5. This is to
avoid unintentional spilling of reagents.
Locate the reagent connectors on the back of the analyzer. Use the supplied connecting
tubes and special bottle caps. Be sure that the color on each tube, cap and connector in the
back of the instrument match.
You can place the reagent containers below the desk Convergys
®
X5 is installed on. The
instrument has sufficient power to draw the liquids from a lower location.
Do not block the small air vent hole on the special container caps in order to provide free
airflow.
Convergys
®
D
il
-
Diff
(D50)
Convergys
®
Diff
-
5P
Convergys
®
Lyse
-
5P
Waste