Convergent Convergys X3 User manual

Convergys®X3
Hematology analyzer ’
User’s Manual
Release 1.5
X3User20140304
Convergent Technologies GmbH & Co. KG
Ringstrasse 14, 35091 Coelbe, Germany
Tel.: [phone]
Fax: [phone]
www.convergent-technologies.de
[e-mail]
CT_X3_ENG_Ver1.5

Convergent Technologies GmbH & Co. KG User manual
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Table of contents
1 INTRODUCTION...................................................................................................... 3
1.1 Intended Use.....................................................................................................3
1.2 The Instrument ..................................................................................................3
1.3 Patient Testing...................................................................................................4
1.4 Reagents...........................................................................................................4
1.5 Technical Operation ..........................................................................................5
1.6 Calibration and Quality Control..........................................................................5
1.7 Instrument features............................................................................................6
1.8 Parts of the Analyzer……………………..............................................................………….…….8
1.9 Function of the Fluidics......................................................................................8
1.10 Control Panels.................................................................................................9
1.11 Display.............................................................................................................9
1.12 Keyboard.........................................................................................................9
1.13 Control Material.............................................................................................12
1.14 Accessories...................................................................................................12
1.15 Specifications ................................................................................................13
2 INSTALLATION ..................................................................................................... 14
2.1 General information.........................................................................................14
2.2 Environmental factors......................................................................................14
2.3 Electrical requirements....................................................................................14
2.4 Space requirements ........................................................................................14
2.5 Peripherals......................................................................................................15
2.6 Reagents and waste handling.........................................................................15
2.7 Maintenance....................................................................................................16
2.7.1 Cleaning....................................................................................................16
2.7.2 General points...........................................................................................16
2.8 Unpacking and installation...............................................................................16
2.8.1 Keyboard and external printer...................................................................17
2.8.2 Host Computer..........................................................................................17
2.8.3 Power supply ............................................................................................17
2.8.4 Reagent Containers..................................................................................17
2.9 Turning the Instrument ON..............................................................................18
2.10 Turning the Instrument OFF..........................................................................19
2.11 Preparing for shipment..................................................................................19
2.12 Emergency handling......................................................................................20
3 MENU SYSTEM ..................................................................................................... 21
3.1 General Information.........................................................................................21
3.2 Navigating in the Menu System.......................................................................21
3.3 Menu structure.................................................................................................22
4 OPERATING PRINCIPLES ................................................................................... 24
4.1 Impedance Method..........................................................................................25
4.2 Principle of HGB Measurement.......................................................................25
4.3 Parameters......................................................................................................25
4.4 Absolute and Linearity Ranges of Measured Parameters ...............................26

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5 ROUTINE UTILIZATION and MEASUREMENT ................................................... 27
5.1 Sample handling..............................................................................................28
5.2 Sample analysis ..............................................................................................30
5.2.1 Sample preparation...................................................................................30
5.2.2 Modifying lyse quantity..............................................................................30
5.2.3 Sample information...................................................................................31
5.3 Results ............................................................................................................32
5.4 Measurement...................................................................................................34
5.4.1 Measure local menu..................................................................................34
5.4.1.1 Blank Measurement ...........................................................................34
5.4.1.2 Using Pre-diluted Mode......................................................................35
6 DATABASE ........................................................................................................... 38
7 UTILITIES .............................................................................................................. 40
7.1 Maintenance....................................................................................................40
7.1.1 Regular Maintenance Jobs.......................................................................40
7.1.2 Cleaning....................................................................................................40
7.2 Priming............................................................................................................41
7.3 Draining chamber............................................................................................41
7.4 Reagent status................................................................................................41
7.4.1 Empty waste container..............................................................................42
8 MAINTENANCE..................................................................................................... 43
8.1 User-accessible parts......................................................................................43
8.2 Maintenance schedule.....................................................................................44
8.2.1 Daily, before daily routine:.........................................................................44
8.2.2 Daily, after daily routine: ...........................................................................44
8.2.3 Weekly:.....................................................................................................44
8.2.4 Semi-annual:.............................................................................................45
8.3 Calibration.......................................................................................................45
8.4 Quality Control Procedure...............................................................................48
8.5 Diagnostics......................................................................................................49
8.5.1 Device Information....................................................................................49
8.5.2 Self Test....................................................................................................49
8.6 Settings ...........................................................................................................49
8.6.1 Printer settings..........................................................................................50
8.6.2 Customize.................................................................................................51
8.6.3 Units..........................................................................................................53
8.6.4 Laboratory information..............................................................................54
8.6.5 User mode settings...................................................................................54
8.6.6 Date and time............................................................................................55
9 Printing ................................................................................................................. 56
9.1 Printouts..........................................................................................................56
10 Fluidic Schematics ............................................................................................. 58
11 Warning labels on the analyzer......................................................................... 59
12 Warranty Information………………………………………………………………...58

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1 INTRODUCTION
1.1 Intended Use
Convergys®X3 hematology analyzer is a fully automated cell counter designed for in vitro
diagnostic use. The instrument was developed for small clinics or laboratories.
1.2 The Instrument
Convergys®X3 is a fully automated, bench top hematology cell counter.
It implements the so-called Coulter-method for counting cells passing through a small
aperture, and measures the hemoglobin content of red blood cells.
The analyzer features a color graphical LCD display module and a foil keypad of 29 keys
including 6 software buttons (with icons), 6 function keys (above LCD) and has a START
button.
The instrument allows printing reports to an external printer (USB port), or can have an
optional built-in printer module.
Its internal memory is capable of storing 5000 records with full histograms, and individual
patient data. QC measurements are stored in a separate database. Upgrade of the software
operating the instrument is possible USB flash memory device. The instrument allows
connecting to a host computer for uploading records stored in its memory through a USB
SLAVE port (USB B) or serial link (RS232). Archiving and restoring of records to and from
USB flash memory device is also possible.
NOTE: If the equipment is used in a manner different from which the manufacturer
specified, the protection provided by the equipment may be impaired. Misuse of
equipment or use other than its intended purpose will invalidate conditions of
warranty. The accuracy and precision may also be impaired.

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1.3 Patient Testing
The analyzer can process 60 samples per hour. Samples can have individual sample data,
and additional parameters. You can print results to an external or to the optional built in
printer. The user can customize the report format.
Convergys®X3 determines 20 hematology parameters including three-part WBC differential.
The instrument requires 25µl of whole blood sample:
WBC total white blood cell count
LYM lymphocytes count
MID MID count
GRA granulocyte count
LYM% lymphocytes percentage
MID% MID percentage
GRA% granulocyte percentage
HGB hemoglobin
RBC red blood cell count
HCT hematocrit
MCV mean corpuscular volume
MCH mean corpuscular hemoglobin
MCHC mean corpuscular hemoglobin concentration
RDWcv red cell distribution width
RDWsd red cell standard deviation
PLT platelet count
PCT platelet percentage
MPV mean platelet volume
PDWcv platelet distribution width
PDWsd platelet standard deviation
1.4 Reagents
Accuracy is guaranteed only if reagents supplied by the manufacturer are used
Convergys®
Dil-DIFF (diluent): Isotonic saline solution, used to dilute whole blood
samples
and to rinse the fluidic system between measuring
procedures.
Convergys®
Lyse-DIFF (lyse): Creates hemolysate for 3-part WBC differential and for
total WBC and HGB.
Convergys®
Cleaner (cleaner): For cleaning process of the fluidi

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1.5 Technical Operation
As Convergys ®X3 is a fully automated instrument, operating it requires minimal training or
technical support. Operator interaction is reduced to the following:
- Perform a Blank Measurement in case the instrument is not used for a specific time
- Enter sample and/or patient data
- Apply the sample for analysis
- Print results either one-by-one, or in groups by selecting records from the database
- Perform simple weekly maintenance, as described later in this description (8.2).
1.6 Calibration and Quality Control
Convergys ®X3 arrives to your laboratory factory-calibrated and ready to use. However,
calibration needs updating whenever you find that the results have slightly changed, or a
different or new control material is used. With each control material you receive for the
instrument, you will find a control sheet listing the parameters the instrument should match.
Perform these calibrations as explained in a later chapter (8.3).
Use Quality Control procedures to check for proper calibration and performance of the
analyzer. Running these samples should happen on a regular basis, as also explained in a
later chapter (8.4).

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1.7 Instrument features
1-1 Front view
1-2 Rear view
HARD Shortcut
keys
SOFT Shortcut
keys
Numerical
keypad
START key
Graphical
LCD
Cursor keys
&
OK key
Sample rotor
with adapter
Power
adapter
connector
USB ports for
printer,
keyboard
Power switch
Reagent
connectors
RS232 port
USB port
Instrument
label
Vent holes
PS2 port
(keyboard)

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Figure 1-3 shows the open built-in printer using roll paper inside.
Press the protruding button to
open the lid. Let the thermal
printer paper fall into the
housing with its open end
toward the paper tearing
(towards the front of the
instrument). Hold the open end
of the paper and close the lid
so that the end of the paper
gets clipped between the black
paper guide and the printer
mechanics.
You can select to use this
printer in the “Printer
Settings” menu (see chapter
8.6.2).
The analyzer works with an external power supply. Figure 1-4 shows the power supply unit
generating 12VDC. The power supply module has a so-called auto range input, allowing
operation on 230V or 115V power system. The power supply complies CE and UL safety
certifications.
The input socket is a standard power cable
connection shipped with the analyzer, the
output is a special, lockable socket as
shown in the picture.
Only the provided power supply shall be
used with the instrument. (“Protek
Electronics Corp.” Model ID: PUP80-12-
N8, or “GLOBTEK INC”, Model ID: GT-
81081-6012-T3”)
1-4
Power supply
Printer lid with
rubber roller
Insert for
thermal paper
Printer
mechanics
Lid opener
button

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1.8 Parts of the Analyzer
Convergys®X3 hematology analyzer is composed of three main units:
Fluidic System: Performs sampling, diluting, mixing, and lysing functions.
Generates the regulated vacuum used for moving cells through
the aperture during the counting process.
Data Processing System: Counts, measures and calculates blood parameters, generates
and stores numerical results and histograms.
Control Panel: Features an LCD display, a 29-button keypad, and USB ports
and serial (computer) interfaces.
1.9 Function of the Fluidics
For the Schematics of the fluidics system, see Section 9.
Sample aspiration and dilution:
Stages of the blood testing process
a.
25 μl of anti-coagulated (K3-EDTA) whole blood sample is aspirated through the sampling
needle and mixed with 4 ml of diluent and stored in the mix chamber (mix dilution).
b.
35 μl of primary dilution is aspirated and then added with 4 ml of diluent into the RBC
chamber (RBC dilution)
c.
The primary dilution remaining in the mixing chamber flows via the tubing into the WBC
chamber where the necessary (preset) amount of lysing reagent is added (WBC dilution).
Table 1.
Dilution rates used within Convergys®X3:
- Primary dilution 1:160
- RBC dilution 1:18 000
- WBC dilution 1:192 (dependent on lyse amount, default volume is
0.8 ml)
Measurement times:
- WBC count 2-6 seconds (depends on the total WBC count)
- HGB measurement 2 seconds
- RBC/PLT count 5 seconds

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1.10 Control Panels
START button - Pressing and releasing the START button triggers an analysis cycle.
Status indicator - A two-color (red/blue) LED is located near the START button.
Its actual color indicates the status of the analyzer.
1.11 Display
The display is 320 x 240 dots, high contrast backlit color graphic LCD module.
1.12 Keyboard
The foil keypad is composed of the following (shown in Section 1.3 - Figure 1):
- Numeric keys for entering numerical data, and selecting menu items
- Function keys with specific functions. These functions are menu-dependent and
are indicated by icons appearing above the keys
- Hardware function keys (short-cut keys) for easier navigation between menus
- Cursor control keys and for moving between database items, and , for moving
between parameter columns or menu levels
- START key for initiating an analysis cycle
- OK key for confirming data
- Del key for deleting characters
- Help key for HELP function