VUM088 - Abacus 3CT User's Manual v1.2

Abacus 3CT
User’s Manual
Revision 1.2
Revision history
Rev Author Changes Effective Date
Márton Rajkai
1.01 Original version 2014-03-18
Árpád Gyetvai
1.03 Árpád Gyetvai Minor changes, dimensions, weight 2014-03-21
1.1 Árpád Gyetvai Minor edits 2014-07-15
1.2 Márton Rajkai New software release update 2014-08-04
Approvals
Ref Team Role Name Signature Date
1 R&D Director Gábor Farkas 2014-07-15
2 QA Mike Switzer 2014-07-15

2 Abacus 3CT User’s Manual
Abacus 3CT
User’s Manual
1.2 Release
Abacus 3CT software v1.2.630
1097 Táblás utca 39.

Budapest, Hungary
Tel: +36 1 4369800
Fax: +36 1 4369809
www.diatron.com
Abacus 3CT User’s Manual 3
This user’s manual is intended to give detailed information for end users and operators of the
Abacus 3CT hematology analyzer.
Warranty
THE WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR
IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR
PURPOSE.
Exemptions
Diatron’s 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
Diatron or repairs by people other than Diatron authorized personnel.
This warranty shall not extend to:
 any Diatron product which has been subjected to misuse, negligence or accident.
 any Diatron product from which Diatron’s original serial number tag or product
identification markings have been altered or removed.
 any product of any other manufacturer.
Company contact
Manufacturer: DIATRON MI ZRT
Address: Táblás utca 39.
Budapest, HUNGARY
H-1097
Contacts: Tel: +36-1-436 9800
Fax: +36-1-436 9809
www.diatron.com
support@diatron.com
Table of Contents
1 Indications for Use............................................................................................. 10
2 For Your Safety ................................................................................................... 11
2.1 Who Should Use This Manual ........................................................................................................ 11
2.2 Special Symbols Used In This Manual and on the Analyzer .............................................. 11
2.3 General Precautions .......................................................................................................................... 11
2.4 Environmental Requirements ....................................................................................................... 13
2.5 Electrical Requirements .................................................................................................................. 13
2.6 Space Requirements ......................................................................................................................... 13
2.7 Weight Requirements ...................................................................................................................... 14
2.8 Waste Disposal .................................................................................................................................... 14
2.9 Known Limitations ............................................................................................................................ 15
2.10 Emergency Situations .................................................................................................................. 15
3 Product Support ................................................................................................. 16
4 Installation ........................................................................................................... 17
4.1 Abacus 3CT Analyzer Package ...................................................................................................... 17
4.2 Accessories ........................................................................................................................................... 17
4.3 Installation check-list ....................................................................................................................... 18
4.3.1 Select a suitable location ........................................................................................................................ 18
4.3.2 Connect reagents ....................................................................................................................................... 18
4.3.3 Connect power ........................................................................................................................................... 19
4.3.4 Connectible peripheral devices ........................................................................................................... 19
5 General Overview and Principles of Operation ....................................... 21

5.1 General Overview............................................................................................................................... 21
5.2 Measured Parameters ...................................................................................................................... 21
5.3 Genuine Reagents .............................................................................................................................. 23
5.4 Optional reagents ............................................................................................................................... 24
5.5 Approved Controls and Calibrator .............................................................................................. 24
5.6 Principles of Operation .................................................................................................................... 24
5.6.1 Photometric Light Absorbance Method ........................................................................................... 25
5.6.2 Volumetric Impedance Method ........................................................................................................... 25
5.6.3 3-Part Differential Analysis Method.................................................................................................. 26

5.6.4 Measurement Sequence ......................................................................................................................... 27
5.7 Parts of the Abacus 3CT Analyzer................................................................................................ 28
5.7.1 Front panel................................................................................................................................................... 28
5.7.2 Rear connectors ......................................................................................................................................... 28
5.7.3 Reagent connectors on the back ......................................................................................................... 29
5.7.4 Left side ......................................................................................................................................................... 29
5.7.5 Right side ...................................................................................................................................................... 29
5.7.6 Built-in Printer ........................................................................................................................................... 30
5.7.7 Loading paper into the built-in printer............................................................................................ 30
6 User Interface ...................................................................................................... 31

6.1 Using the Touch Screen ................................................................................................................... 31
6.2 Using an External Keyboard .......................................................................................................... 31
6.3 Sections of the Graphical User Interface ................................................................................... 31
6.3.1 Button color ................................................................................................................................................. 32
6.3.2 Entering Information............................................................................................................................... 32
6.4 Menu System........................................................................................................................................ 32
6.4.1 Main Menu ................................................................................................................................................... 32
6.4.2 Menu Tree .................................................................................................................................................... 33
6.4.2.1 Measure menu ............................................................................................................................................................ 33
6.4.2.2 Database menu .......................................................................................................................................................... 33
6.4.2.3 Quality Control menu .............................................................................................................................................. 33
6.4.2.4 Maintenance menu ................................................................................................................................................... 33
6.4.2.5 Settings menu ............................................................................................................................................................. 34
6.4.2.6 Exit menu...................................................................................................................................................................... 34
7 Start-up and shut down of Abacus 3CT....................................................... 35

7.1 Turning the Instrument ON ........................................................................................................... 35
7.2 Turning the Instrument OFF.......................................................................................................... 36
7.3 Preparing for shipment ................................................................................................................... 37
7.4 Emergency shut-down ..................................................................................................................... 37
8 Sample Measurement ....................................................................................... 38
8.1 Sample Tube Support of Abacus 3CT ......................................................................................... 38
8.1.1 Supported Sample Tube Types............................................................................................................ 38
8.1.2 Sampling Depth .......................................................................................................................................... 38

8.2 Introducing sample, sample adapters ........................................................................................ 39
8.2.1 Standard sample adapter ....................................................................................................................... 39
8.2.2 Microtainer adapter ................................................................................................................................. 39
8.2.3 Small control adapter .............................................................................................................................. 40
8.3 Sample Collection and Handling .................................................................................................. 40
8.4 Sample Types and Modes................................................................................................................ 41
8.5 Sample Identification........................................................................................................................ 41
8.6 Running Samples................................................................................................................................ 42
8.6.1 Running Blank measurement............................................................................................................... 42
8.6.2 Patient Sample Run .................................................................................................................................. 43
8.6.3 Remote work list (EMR) mode ............................................................................................................ 44
8.6.4 Pre-diluted Sample Run.......................................................................................................................... 45
8.6.5 Small Sample Mode (SSM) ..................................................................................................................... 46
8.6.6 Control Runs and Control Bar Codes ................................................................................................ 46
9 Interpretation of Results ................................................................................. 47

9.1 Results Screen ..................................................................................................................................... 47
9.1.1 Parameter screen ...................................................................................................................................... 47
9.1.2 Normal ranges screen ............................................................................................................................. 47
9.1.3 Technical details screen ......................................................................................................................... 48
9.2 Parameter Flags .................................................................................................................................. 48
9.2.1 Out of Normal Range flags ..................................................................................................................... 48
9.2.2 Measurement condition flags ............................................................................................................... 49
9.2.2.1 Flagging on WBC and HGB channels ................................................................................................................. 49
9.2.2.2 Flagging on RBC/PLT channel ............................................................................................................................. 49
9.2.3 Warning flags of Differential Parameters ....................................................................................... 50
9.2.4 Blank measurement flagging ................................................................................................................ 50
9.3 Known Limitations in WBC Differentials .................................................................................. 51
10 Database Operations ........................................................................................ 52
10.1 Main database menu..................................................................................................................... 52
10.2 Database detail view..................................................................................................................... 53
10.2.1 Editing stored records........................................................................................................................ 53
10.3 Filtering and Selecting records in database ........................................................................ 54
10.4 Managing selected records in database ................................................................................ 56

10.4.1 Deleting selected records.................................................................................................................. 56
10.4.2 Sending selected records to computer or LIS ........................................................................... 57
10.4.3 Backup of selected records .............................................................................................................. 58
10.4.4 Backup view function ......................................................................................................................... 59
10.4.5 Backup one day ..................................................................................................................................... 60
10.5 Statistics of selected records ..................................................................................................... 60
10.6 Printing selected records ............................................................................................................ 61
10.6.1 Handling print jobs .............................................................................................................................. 61
11 Maintenance menu ............................................................................................ 62

11.1 Cleaning ............................................................................................................................................. 62
11.2 Calibration Menu ........................................................................................................................... 63
11.2.1 Calibration Factors menu.................................................................................................................. 63
11.2.2 Calibration with Measurement ....................................................................................................... 64
11.2.3 Calibration History and Calibration Database ......................................................................... 65
11.2.4 Pre-diluted Mode Calibration menu ............................................................................................. 66
11.3 Diagnostics menu .......................................................................................................................... 67
11.3.1 Device Information .............................................................................................................................. 67
11.3.2 Device statistics .................................................................................................................................... 67
11.3.3 Self-test ..................................................................................................................................................... 68
11.4 Reagent Status ................................................................................................................................ 68
11.4.1 Replacing Reagents ............................................................................................................................. 69
11.4.2 Reagent Lock System .......................................................................................................................... 69
11.4.3 Measurement credits menu ............................................................................................................. 70
11.4.4 Liquid sensors ....................................................................................................................................... 71
11.4.5 Reagent log menu ................................................................................................................................. 71
12 Quality Control (QC) Menu.............................................................................. 72

12.1 QC database...................................................................................................................................... 72
12.1.1 Entering New Lot of QC material ................................................................................................... 73
12.1.2 Levy-Jennings QC chart ...................................................................................................................... 73
13 Multi-User Mode ................................................................................................. 74

13.1 Types of Users ................................................................................................................................. 74
13.2 Logging in ......................................................................................................................................... 74

13.3 User Management.......................................................................................................................... 75
13.3.1 Add new user ......................................................................................................................................... 76
13.3.2 Deleting or Editing Users .................................................................................................................. 76
13.3.3 Automatic login set .............................................................................................................................. 76
14 Settings menu ...................................................................................................... 77

14.1 General settings .............................................................................................................................. 77
14.2 Communication settings ............................................................................................................. 79
14.2.1 Device communication....................................................................................................................... 79
14.2.1 Peer communication ........................................................................................................................... 80
14.3 Measurement settings ................................................................................................................. 81
14.3.1 Measurement units settings ............................................................................................................ 81
14.3.2 Normal ranges settings ...................................................................................................................... 82
14.4 Date and time settings ................................................................................................................. 82
14.5 Printer settings ............................................................................................................................... 83
15 Routine Maintenance........................................................................................ 84
15.1 User-accessible parts ................................................................................................................... 84
15.2 Maintenance schedule ................................................................................................................. 85
15.2.1 Daily maintenance, before daily routine .................................................................................... 85
15.2.2 Daily maintenance, after daily routine ........................................................................................ 85
15.2.3 Weekly maintenance........................................................................................................................... 85
15.2.4 Semi-annual Maintenance ................................................................................................................ 85
15.3 Cleaning the Analyzer .................................................................................................................. 86
16 Troubleshooting................................................................................................. 87
16.1 Error messages ............................................................................................................................... 87
16.2 Pneumatic/mechanical error messages ............................................................................... 87
16.3 Mechanical Problems ................................................................................................................... 88
16.3.1 Sample Rotor Failures ........................................................................................................................ 88
16.3.2 Needle Mechanics, Vertical Motor (MVert) Problems .......................................................... 88
16.3.3 Needle Mechanics, Horizontal Motor (MHori) Problems .................................................... 88
16.3.4 Dilutor Errors ........................................................................................................................................ 88
16.3.5 Priming Problems – reagent warnings ........................................................................................ 88
16.3.6 Touch screen is not working ........................................................................................................... 89

16.3.7 The Analyzer Does Not Power On ................................................................................................. 89
16.4 Problems related to Measurement results .......................................................................... 89
16.4.1 Measurement with Warning Flags ................................................................................................ 89
16.4.2 Fluctuating PLT background ........................................................................................................... 89
17 Performance Characteristics ......................................................................... 90

17.1 Accuracy ............................................................................................................................................ 90
17.2 Precision............................................................................................................................................ 90
17.3 Linearity ............................................................................................................................................ 91
17.4 Carry-over ........................................................................................................................................ 91
17.5 Sample Stability .............................................................................................................................. 91
17.6 Reference ranges ........................................................................................................................... 92
17.7 Interfering Substances................................................................................................................. 92
18 Print Formats ...................................................................................................... 93
18.1 Print Formats of built-in printer.............................................................................................. 93
18.2 Table print format ......................................................................................................................... 94
18.3 Print formats of external printer ............................................................................................. 94
19 Specifications ...................................................................................................... 95
19.1 Reagent consumption chart of Abacus 3CT ......................................................................... 96
20 Fluidic Schematics ............................................................................................. 97
21 Calibration of Bar Code Reader (Motorola DS4208 only) .................... 98
1 Indications for Use

Abacus 3CT is a quantitative, fully automated, multi-parameter, bench-top automated hematology
analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the
following 22 hematology parameters:
WBC, LYM%, LYM#, MID%, MID#, GRA%, GRA#, RBC, HGB, HCT, MCV, MCH,
MCHC, RDW-SD, RDW-CV, PLT, MPV, PCT, PDW-SD, PDW-CV, P-LCR, P-LCC.
The analyzer takes 100l of K2 or K3-EDTA anti-coagulated whole blood from open or closed sample
vial placed into an adapter in the sample rotor station. It can process 60 samples per hour.
The instrument has an option (can be set by service person) to take 25l of whole blood sample
from open vial.
Abacus 3CT is indicated for use in identifying patients with hematologic parameters within and
outside of established reference (normal) ranges.
If equipment operation is different from the manufacturer’s specifications and

intended use, 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.
2 For Your Safety

2.1 Who Should Use This Manual
This user’s manual is intended for clinical laboratory professionals using the Abacus 3CT automated
hematology analyzer. This manual includes information about the operation and user interface of
the analyzer, and also describes daily routine maintenance requirements to keep your analyzer
functioning properly.
Please, go through this manual before operating the analyzer.
2.2 Special Symbols Used In This Manual and on the Analyzer
Label Meaning Explanation
Blood samples and analyzer waste are potentially infectious

Biohazard
materials. Please, handle them accordingly.
Corrosive Reagents may cause corrosion or skin irritation.
Warning General warning of possible hazard conditions.
Sharp needle warning The sampling needle may be a hazard to the operator.
2.3 General Precautions

Please, read this section carefully before operating the analyzer.
The sampling needle and other components inside the analyzer may cause injury, or can
get damaged if handled incorrectly. Only certified personnel should open the covers.
Running samples with opened cover is not recommended due to the risk of possible
injury. Always wear safety gloves while performing maintenance actions.
The analyzer should be moved holding the analyzer in an upright position.
Make sure to retain the original packaging material for safe transportation and storage
in the future.
To prepare the analyzer for shipping, storage or extended periods of inactivity, please
drain the reagents (run Preparing for shipment procedure) and repackage it in its
original packaging.
Do not expose the Abacus 3CT to direct sunlight, extreme temperature or humidity over
80%.
The analyzer operates with chemically and biologically active reagents. Physical contact
with these reagents should be avoided. Please read reagent descriptions and MSDS
carefully for possible emergency actions.
To ensure reliable operation and reliable results:

 Only human blood samples should be analyzed
 Only genuine Diatron reagents should be used
 Required user maintenance should be performed as detailed in this manual
 Only Diatron certified service personnel should perform service actions
 Only genuine Diatron service materials and spare parts should be used
Only Diatron certified service personnel that have successfully completed the Abacus
3CT Service Training program are qualified to service the Abacus 3CT analyzer.
Before operating the Abacus 3CT analyzer, all operators should complete an Abacus 3CT
Operator Training program. This program is offered by certified service personnel of
Diatron.
Replacement materials or spare parts (tubes, valves, etc.) which might have been in
contact with human blood or reagents should be handled as a potentially biologically
hazardous and chemically dangerous material. All applicable laws and regulations must
be observed in the handling and disposal of these materials.
Abacus 3CT is designed for laboratory operation. Mobile operation is not supported.
Operate it within the ambient temperature range described in section 2.4.
This IVD equipment complies with the emission and immunity requirements described
in relevant part of the IEC 61326 series.
This equipment has been designed and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take
measures to mitigate the interference.
Electromagnetic environment should be evaluated prior to operation of the device.
This analyzer contains electronic components. Please handle electronic waste

adhering to local or federal regulations.
Waste contains poisonous substances (because of chemical content) and human origin
substances meaning biohazard. These substances are representing potential danger to
environment. For this reason, safe handling of the waste liquid is very important.
2.4 Environmental Requirements

Operate Abacus 3CT analyzer within the ambient temperature range of 15-30°C (59-86 °F) and a
relative humidity range of 10-80%. The optimum operating temperature is between 20-25°C (68-
77°F).
Abacus 3CT should be stored within the temperature range of 5-35°C (41-95°F). Avoid exposing it to
direct sunlight or to extreme high or low temperatures. If the analyzer was subjected to extreme
temperatures during shipment or storage, the analyzer must be placed for at least one hour in a
room whose temperature is within the operational range before installation or use.
Reagents should be stored at a temperature range of 15-30°C (59-86 °F). Reagents may experience a
temperature range of at most 5-35°C (41-95 °F) for a maximum of 3 days.
Analyzer operation at an altitude above 2000 meters (6560 feet) is not guaranteed.
2.5 Electrical Requirements

The analyzer should only be operated from a wall outlet meeting these power input requirements:
 The analyzer MUST be operated from its power supply module packaged into the
accessory box
 Input voltage: 100-240VAC; 47Hz to 63Hz, max. 100 VA
 The analyzer must be earth grounded
Abacus 3CT analyzer comes with a power cord appropriate for your power system. Use of the
appropriate power cord assures adequate grounding of the system. If the power is not reliable,
contact your representative for options such as installation of an external UPS (uninterruptible
power supply) module.
Failure to properly ground Abacus 3CT 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, 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.
2.6 Space Requirements

It is important to install the instrument in a suitable location. A poor location can adversely affect its
performance. Select a well-ventilated location near a power source and close to a suitable drain.
Place the unit on a clean, level surface. Leave at least 0.5 m (18 inches) space on both sides and
above the instrument to access pneumatics and the back easily. A minimum of 0.2 m (8 inches) must
be maintained between the rear panel and the wall to allow for heat dissipation and tubing
clearance.
Figure 1. Abacus 3CT Space Requirements
For recommended placement of the reagents, see section 4.3.2
Placing reagents above the analyzer could result in reagent overflow and spilling.
2.7 Weight Requirements

Please select a table, laboratory shelf, or other location which can support the weight of Abacus 3CT
with accessories, and is free from vibration from other devices.
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.
2.8 Waste Disposal

Abacus 3CT analyzer waste contains human blood and reagents that are chemically and biologically
active, and should be considered to be potential infection and biohazard threat. Safe laboratory
practices must be followed including the use of personal protective when operating the Abacus 3CT
and handling blood, reagents, and waste.
System waste should be handled as a potentially bio-hazardous material. All applicable

laws, regulations, and laboratory practices should be followed in the handling and
disposal of waste.
2.9 Known Limitations

Abacus 3CT is not intended for analysis of animal blood samples. Anti-coagulated and homogenized
(well-mixed) human blood samples must be free from contamination and clots.
Blood samples should be analyzed within 7 hours of venipuncture, otherwise precision is not
guaranteed, especially on 3-part differential WBC parameters.
2.10 Emergency Situations

Always follow all applicable laws and regulations in regards to emergency situations.
The following list provides some examples when emergency shutdown is needed:
 Personal injury or risk of personal injury
 Fire or flood in the laboratory, or wrong reagent is connected to Abacus 3CT
 Risk of high voltage on the electric grid so that Abacus 3CT can sustain permanent damage
In emergency situation, cut off power by disconnecting mains power cable, or turning the main
switch off. In case of electric risk, cut off power from external power supply unit, do not use the
main switch.
Use a fire extinguisher if necessary.
In case of fire, do not use water to extinguish the fire unless the Abacus 3CT is
disconnected from the electrical power network.
After emergency power off, be cautious when reaching into the unit through the side
door, since the sampling needle may be in a position that it can cause injury.
3 Product Support
Your sales representative is trained and qualified to answer questions about applications and the
operation of the Abacus 3CT analyzer. If you have additional questions regarding the Abacus 3CT,
please ask for manufacturer support through your sales representative.
Diatron makes every effort to provide excellent support and up to date information and services
regarding the Abacus 3CT analyzer. Software updates and application documents are available on
the Diatron web site at http://www.diatron.com.
4 Installation
Your Diatron certified service engineer will perform the initial installation of Abacus 3CT analyzer
and train selected laboratory personnel on the proper use and maintenance of it.
The analyzer should be operated by properly trained laboratory personnel only.
4.1 Abacus 3CT Analyzer Package

After opening the Abacus 3CT analyzer 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 desiccant
packs. The package should contain the following items:
 Abacus 3CT analyzer in a plastic bag
 Accessory box on top of the analyzer
Retain the original analyzer packaging for future transportation and storage.
4.2 Accessories
The accessories box of Abacus 3CT contains the following items:
 User’s Manual (this document)
 Reagent tube kit in a plastic bag, with 3 caps and 5
color-coded tubes:
o Diluent tube (green)
o Lyse tube (yellow)
o Cleaner tube (blue)
o 2x Waste tubes (red)
 Power cord
 External 12 VDC power
supply unit
 3 sample tube adapters for the sample rotor

 Plastic waste container (20 L)
 Cardboard box for the waste container
 “Preparing for shipment” tube kit
 2 pcs of roll paper for built-in printer
Please, inform your sales representative if any item is missing or damaged.

4.3 Installation check-list

Abacus 3CT is a complex medical device. Follow the checklist below for important information.
Always handle the instrument with care. Refer to Chapter 2 for Safety and other requirements.
4.3.1 Select a suitable location

 Ensure that enough space is available for the analyzer and optional printer on a level, well-
supported surface with adequate space available.
 Place the analyzer in a well-ventilated location. Avoid placing it in areas of extremely high
or low temperatures, air-flow or where it is exposed to direct sunlight.
 Do not place it near potentially interfering devices capable of emitting radio frequencies
(e.g. radio or television transmitters, radars, centrifuge, X-ray devices, fans, etc.).
4.3.2 Connect reagents

Abacus 3CT is capable of aspirating reagents from 3.3 ft. (1m) below the analyzer’s base.
 Place the Diluent and Waste tanks below the analyzer, and the Lyse and Cleaner bottles on
the same level, near the back or side of the analyzer.
Figure 2. Recommended placement of Reagents and Waste
 Connect the reagent tubes to the analyzer, use the supplied connecting tubes and special
bottle caps. Do not block the small air vent hole on the container caps to provide air flow.
Vent hole
 Be sure that the color on each tube, cap and connector in the back of the instrument match;
 Before putting the drop-down tubes into the reagent containers, wipe the dust off from
them using a lint-free wet paper wipe
 Use separate Waste lines for the waste tank connections as indicated below:
Figure 3. Establishing correct waste connection
4.3.3 Connect power

 Make sure that the main switch (next to the power connector at rear) is in ‘0’ position;
 Connect the DC cable of the external power supply module to the Abacus 3CT power input.
 Tighten the connector by turning the securing screw (2 – 3 turns).
 Connect the power cord to the external power supply;
 Plug-in the power cord into the wall-outlet. See section 2.5 for electrical requirements.
 Connect keyboard and LAN (Ethernet) cables to the appropriate connectors (optional);
 Power up the Abacus 3CT by flipping the power switch to on ‘I’ position;
 Check the operational status of the peripherals and the operation of touch screen.
4.3.4 Connectible peripheral devices

Abacus 3CT is capable of connecting to the following peripherals:
 Various HP printers directly to USB port or printers through optional PrinterBox® device
 Keyboard with USB connector
 Bar-code readers with USB connector
 USB memory devices up to 16 Gbytes in capacity (such as a USB pen drive)
 Host computer via USB link connected to USB B port on the back. (To utilize this USB
connection, you need a USB cable, and a suitable driver should be installed on the computer.
Refer to your service personnel for instructions.)
 Host computer or local area network (LAN) via Ethernet link.
As a general rule: if the peripheral you want to connect has its own power source /
power supply then turn off both the peripheral device to be connected and the Abacus
3CT instrument as well before connecting the peripheral device.
The peripheral connectors on Abacus 3CT are SELV (safety extra low voltage)
connectors, only connect external devices that are SELV rated to the instrument.
5 General Overview and Principles of Operation

5.1 General Overview
Abacus 3CT is a fully automated, high quality hematology analyzer for in vitro diagnostic use in
clinical laboratories. It provides precise and accurate 3-part WBC differential measurement results
using impedance measurement technology.
Abacus 3CT analyzer uses the impedance 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. 3-part WBC
differential (LYM%, MID%, GRA%) is accomplished by using a differential lysing reagent.
A vivid color touch-screen display is featured with an intuitive, informative, and attractive user
interface.
Abacus 3CT analyzer’s unique software system supports the use of commonly used external printers
of HP brand with USB connections. The internal database is capable of storing 10,000 patient
results, separate QC, and calibration result records including flags and graphical histograms. System
software is field-upgradeable via a USB storage device to ensure up-to-date operation.
Abacus 3CT features advanced Ethernet LIS connectivity using the HL7 protocol in addition to
standard serial interfaces (via USB B port), providing the clinical laboratory with flexible
connectivity options.
5.2 Measured Parameters

Abacus 3CT determines 22 hematology parameters including 3-part WBC differential.
The analyzer samples 100 l of whole blood from a Closed or Open sample vial placed in the sample
rotor. Option for 25l open vial sampling and Pre-diluted sample mode can be enabled.
Measurement cycle time is 60 seconds.
Parameter Description Unit Calculation method
WBC White Blood Cell count cells/l, cells/µl Number of leukocytes

WBC = WBCcal x counted WBC (cells/l, cells/µl)
RBC Red Blood Cell count cells/l, cells/µl Number of erythrocytes

RBC = RBCcal x counted RBC (cells/l, cells/µl)
HGB Hemoglobin g/dl, g/l, mmol/l Measured photometrically at 540 nm; in each cycle
concentration blank measurement is performed on diluent.
HGB = HGBcal x (HGBmeasured – HGBblank)
MCV Mean Corpuscular fl Average volume of individual erythrocytes derived from
Volume the RBC histogram.
HCT Hematocrit percentage, Calculated from the RBC and MCV values.
absolute HCTpercentage = RBC x MCV / 10
HCTabsolute = HCTpercentage / 100
MCH Mean Corpuscular pg, fmol Average hemoglobin content of erythrocytes, calculated
Hemoglobin depends on HGB from RBC and HGB values.
unit selected MCH = HGB / RBC
MCHC Mean Corpuscular g/dl, g/l, mmol/l Calculated from the HGB and HCT values.
Hemoglobin equals to HGB MCHC = HGB / HCTabsolute
Concentration unit selected
RDW-SD Red Cell Distribution fl Distribution width of the erythrocyte or platelet
Width – SD population derived from the histogram at 20% of peak
PDW-SD Platelet Distribution fl
Width – SD
RDW-CV Red cell Distribution %
Width – CV
PDW-CV Platelet Distribution %
Width – CV
xDW-SD = RDWcal x (P2 - P1) (fl),
xDW-CV = RDWcal x 0.56 x (P2 - P1) / (P2 + P1)
by the factor of 0.56 CV is corrected to the 60% cut
PLT Platelet count cells/l, cells/µl Number of thrombocytes (platelets)
PLT = PLTcal x counted PLT
PCT Thrombocrit percentage, Calculated from the PLT and MPV values
absolute PCTpercentage = PLT x MPV /10.000
PCTabsolute = PLT percentage /100
MPV Mean Platelet Volume fl Mean volume of platelets derived from PLT histogram
MPV has its own calibration factor.
P-LCC Large PLT count cells/l, cells/µl Number of platelets larger than 12fl in size
P-LCR Large PLT percentage % Percentage of platelets larger than 12fl in size
P-LCR = P-LCC/PLT
White blood cell 3-part Absolute values counted in the channels determined by
differential: the three WBC discriminators:
LYM, LYM% count and % of

lymphocyte cells
cells/l, cells/µl
MID, MID% count and % of medium and %
size cells
LYM MID GRA
GRA, GRA% count and % of

granulocyte cells
Percentages calculated from the absolute WBC value.
WBC = LYM+MID+GRA
LYM% = LYM/WBC, MID% = MID/WBC,

GRA% = GRA/WBC
Table 1. Parameters determined by Abacus 3CT

5.3 Genuine Reagents

For operating Abacus 3CT analyzer use the following reagents only. All these reagents are for in-
vitro use only. Open bottle stability for all reagents is 120 days.
Reagent storage temperature: 15-30 °C (59-86 °F).
If eyes or skin gets contact with any of the reagents, flush abundantly with water.
If a large quantity ingested, drink water immediately and contact a doctor.
MSDS (Material Safety Data Sheet) of these reagents can be downloaded from Diatron’s
website: www.diatron.com
Performance and lifespan of the Abacus 3CT are guaranteed only if reagents supplied
by the manufacturer are used.
Ordering code, volume Color code

Packaging Description
Name Shelf life
D1512 20 L cubitainer Green This is an isotonic, filtered saline
DiatroDil-5P diluent 3 years solution, used to dilute whole blood
samples and rinse the fluidic system
between measuring cycles.
It is connected to a dedicated diluent
input at the rear of the analyzer.
D2011HK 1L bottle Yellow Lyse reagent is connected to the rear

DiatroLyse-DIFF lyse 4 years reagent input.
It creates hemolysate for 3-part WBC
Comes with a reagent differential, total WBC count and HGB
key attached to the determination.
bottle in a plastic zip-bag. Reagent key attached to the bottle
contains 900 measurement credits.
D5011 1L bottle Dark Blue Cleaning solution of the fluidics,

DiatroCleaner cleaner 4 years connected to the dedicated rear
reagent input.
The analyzer uses this reagent from

time to time, to clean the tubing,
counting chambers and apertures.
D8011 100 ml Black Used for Hard Cleaning procedure to

DiatroHypoClean CC 15 months remove protein and lipids from sample
emergency cleaner tubes, chambers and apertures.
This reagent should be dispensed into
a sample vial, put into the sample
rotor before Hard cleaning is started.
Table 2. Genuine Abacus 3CT Reagents
5.4 Optional reagents

Below reagents are optional for use, maintenance and preparing for shipment of Abacus 3CT.
Ordering code,
volume Color code
Packaging Description
Shelf life
Name, reagent type
Removes salts from tubing during “Preparing
D4011 1L bottle White
1L plastic packaging for shipment” procedure.
DiatroRinse-VET similar to D5011 3 years In its absence, DI water can be used.
Rinsing solution
D6011 1L bottle Light blue Optional cleaner instead of D5011.
1L plastic packaging Used for service maintenance for removing
DiatroClenz 2 years
similar to D5011 debris from tubing.
Enzymatic cleaner
D7011 1L bottle Purple
1L plastic packaging Optional reagent. Used for service maintenance
DiatroHypoClean 2 years
similar to D5011 for removing debris from tubing and chambers.
Hypochlorite solution
Table 3. Optional Abacus 3CT Reagents
For reagent consumption information, see section 19.1.
5.5 Approved Controls and Calibrator

Hematology controls and optional calibrator are used to check precision, accuracy and to calibrate
the system, if necessary. Below control and calibrator products are optimal to use with Abacus 3CT.
Material Purpose Availability
Control material Checking the performance of Diacon3 Hematology Control
(low, normal, high) Abacus 3CT
Calibrator Material (optional) Performing calibration of DiatroCal Hematology
Abacus 3CT Calibrator
Table 4. Approved controls and calibrator
You can find useful information on using these products in their package insert. Look for the assay
sheets indicating ‘Abacus 3CT’.
5.6 Principles of Operation

Abacus 3CT analyzer uses a combination of methods to determine measurement results:
 Volumetric impedance method is used to determine the cellular concentrations and volume
distributions of erythrocytes (RBC), and platelets (PLT) from so-called RBC dilution.
 Volumetric impedance method is used in combination with a lytic reagent to determine
distribution of leukocytes (WBC), and their three sub-populations (LYM, MID, GRA).
 Photometric measurement of light absorbance of the WBC dilution determines hemoglobin
(HGB) concentration of erythrocytes (RBC).
5.6.1 Photometric Light Absorbance Method

A lysed blood sample (WBC) dilution is analyzed for hemoglobin (HGB) concentration based on its
stable chromogen content.
The lyse reagent lyses the red blood cells causing
them release cellular hemoglobin. The hemoglobin
concentration is measured by taking a photometric
reading across the Abacus 3CT WBC chamber. HGB
result is calculated as the difference between and
blank and a sample measurement with and without
illumination to reduce the effect of liquid refraction
and incident light.
Figure 4. Photometric Light Absorbance Method
5.6.2 Volumetric Impedance Method

Volumetric impedance method determines cellular concentrations and volume distributions of cells
by detecting and measuring changes in electrical impedance when particles suspended in a
conductive liquid pass through a small aperture.
Figure 5. Volumetric Impedance Method
A constant direct current flows between the electrodes on both sides of the aperture. Each cell
passing through the aperture causes a change in the electrical impedance of the conductive blood
cell suspension (diluted blood). This impedance change is detected by the Abacus 3CT electronics
and converted to an electrical voltage pulse.
The number of pulses is proportional to the number of particles in the diluted sample.
Intensity (amplitude) of each voltage pulse is proportional to the volume of the particle. The volume
distribution diagrams of the particles are displayed as the WBC, RBC, and PLT histograms measured
in femtoliter (fl, µm3) units.
Electronic discrimination by size allows separation of platelets (PLT) and erythrocytes (RBC), and
WBC populations. Discriminators are indicated by dotted vertical lines on the histograms.
Figure 6. RBC histogram Figure 7. WBC histogram
5.6.3 3-Part Differential Analysis Method

Abacus 3CT is a 3-part WBC differential hematology analyzer. It uses a WBC lytic process that allows
the instrument to simultaneously count and size-differentiate the white blood cells. There are three
elements controlling where the different cell types fall in the 3-population WBC histogram:
 Chemical formulation and concentration of the lytic reagent:
It controls how different WBC types are differentially lysed. Concentration of the lytic
reagent controls the rate of the lysing (shrinking) process.
 Cell type and maturation of the cell types present for analysis:
Different WBC types and their grade of maturation have different sensitivities to the lytic
reagent. Different WBC types lyse at different rates: lymphocytes are the most sensitive,
while band neutrophils and segmented neutrophils are the least sensitive. Eosinophils,
basophils, immature granulocytes and blasts also have a cell wall membrane that is more
sensitive to the lytic process thereby moving them into the Mid-size cell population
following the lytic process and at the time, these cells are counted and sized.
 Time window in the lytic process that the cells are counted and sized:
The lytic process is a dynamic reaction, not a static reaction. Therefore, the count and sizing
time window used during the lytic process has been optimized for performance.
Data of particles are used to present a size distribution histogram of the WBC populations.
Since size distribution is the only data available for the WBC histogram, there is no enough
resolution to accurately differentiate more than three distinct WBC populations.
Based on this fact, all possible normal and abnormal WBC cell types fall into those three histogram
populations. This being the case, there is also not enough resolution to generate accurately specific
morphological flags when abnormal WBC populations are present in the sample.
This is a known limitation of all 3-part differential WBC cell counter systems that are in the market
today. Based on the above facts, Abacus 3CT does not have the ability to generate specific
morphological flags.
5.6.4 Measurement Sequence

For the Schematics of the fluidic system, see section 20.
Stages of blood testing process during normal mode:
The sampling needle moves into the sample vial, and takes 100 µl of EDTA anti-coagulated
venous whole blood sample.
1.
A precise amount of 25µl of this sample is separated in the sampler head. Remaining blood
is disposed through sampling needle into a dedicated washing chamber.
The 25µl of whole blood sample is transported to the MIX chamber through the sampling
needle with an addition of 4ml Diluent, to form 1:160 primary dilution.
2.
25µl of this diluted sample is aspirated into the sampler head, and then mixed with another
4 ml of diluent dispensed into the RBC chamber. This forms a 1:25,600 overall RBC dilution.
Remaining MIX dilution is moved into the WBC chamber where typically 0.9 ml of lysing
3, reagent is added. Abacus 3CT uses bubbles for mixing lyse with MIX dilution.
This lytic dilution of 1:196 is suitable for photometric measurement and WBC counting.
4. WBC cell counting is performed. HGB is measured at the end of the WBC counting process.
5. RBC and PLT measurement is performed.
The system drains and cleans measuring chambers and related tubing, and prepares for the
6.
next blood sample. Apertures get cleaned with high voltage burning pulses.
Table 5. Sample preparation process
Nominal dilution rates used in Abacus 3CT:

 Primary dilution 1:160
 Total RBC dilution 1:25,600
 WBC dilution 1:196
Measuring times:
 WBC count (adaptive) 2-6 seconds
 HGB measurement 2 seconds
 RBC/PLT count 5 seconds
5.7 Parts of the Abacus 3CT Analyzer

5.7.1 Front panel
LCD
touchscreen
Sample rotor
station
5.7.2 Rear connectors
Reagent Key
Slot
Main Power
Switch
Grounding
Screw Power
Connector
Reagent USB ports

Connectors
LAN port
USB B port
5.7.3 Reagent connectors on the back
Diluent inlet
Lyse inlet
Cleaner inlet
Waste #1
connector
Waste #2
connector
5.7.4 Left side
USB-A port
connectors
5.7.5 Right side
Side door
lock
5.7.6 Built-in Printer

Abacus 3CT is equipped with an optional built-in thermal printer.
This printer is capable of printing on 58 mm wide thermal paper.
 If the status LED is lit, the printer is ready to use.
 If the status LED is blinking, then reload paper.
 Push the button on the right to advance paper.
5.7.7 Loading paper into the built-in printer

 Open the paper lid (pull the lid upwards by the handle)
 Remove central plastic roller of old paper roll
 Unwind new paper roll, so that the “starting edge” is coming
from down under towards you.
 Gently drop the new roll into the holder of the printer, hold
“starting edge” with your hand, and make sure it comes out on
the front of the printer as indicated in the picture
 Close the lid, making sure that the paper captured between it
and the printer mechanics, and it is securely closed
6 User Interface
The user interface of the Abacus 3CT analyzer is designed to be intuitive and easy to use, and
provide access to all user level functions. You can interact with the Abacus 3CT by using only the
touch screen and the virtual on-screen keypad, or by using an external keyboard.
6.1 Using the Touch Screen

The touch screen is a capacitive sensor behind a glass. It must be operated by finger or a conductive
stylus designed for capacitive touch screens, since it is not sensitive against pressure.
The touch screen allows selection of menu items and ‘pressing’ of buttons by gently tapping the
surface over the selected item. The touch-screen device used in the Abacus 3CT analyzer is selected
for reliability, endurance and compatibility with the medical laboratory environment. Simple
operations are supported, but multi-touch ‘gestures’ or multiple tapping are not supported.
The surface glass material is resistant to liquids, however it should be dry when in use, otherwise it
may not work reliably. Use a damp cloth to clean the glass surface when the analyzer is turned off.
6.2 Using an External Keyboard

An external keyboard provides the same data entry features as the on-screen virtual keypad
presented by the touch screen, with faster typing.
6.3 Sections of the Graphical User Interface

The graphical user interface (GUI) of Abacus 3CT is menu driven, and changes its contents based on
the function selected.
Current time
Warning message
indicator
Selectable menu
buttons
Title of Menu or
function
Background image
(Inactive area)
Context sensitive
function buttons
Figure 8. Graphical User Interface Sections

Tap on the warning message indicator in the header for details.
6.3.1 Button color

Active buttons are displayed in full color, while inactive or not selectable buttons remain faded.
6.3.2 Entering Information

Abacus 3CT sometimes requires the operator to enter information such as sample ID or patient
data. In order to enter information into a data field simply tap or click on its box. The data field will
change color indicating that data entry is active for that field. Information can be entered using the
virtual on-screen keypad or with an optional external keyboard.
Data is not saved until user presses Enter or Save or Accept to proceed.
6.4 Menu System

Abacus 3CT offers a menu tree to access all functions.
6.4.1 Main Menu

The Main menu will appear after start-up or when Home button is pressed in the menu tree.
Figure 9. Abacus 3CT Main Menu
The different sub-menus are available by pressing their Name or icon.

6.4.2 Menu Tree

The following is a listing of the Abacus 3CT analyzer main menu tree.
6.4.2.1 Measure menu

 New Sample – with the following options:
o Run
o Blank
o Normal Range
o EMR (LIS) – Remote work list
 Re-run
 Print
 Discard
 Back to Main menu
6.4.2.2 Database menu

 Details
 Print
 Statistics
 Filter
 Manage
6.4.2.3 Quality Control menu

 New Lot
 Delete
 Print
 Export
 Monthly view
6.4.2.4 Maintenance menu

 Cleaning
 Calibration
 Diagnostics
 Reagent Status
6.4.2.5 Settings menu

 General
o Sound (enable or disable)
o Language selection
o Export format (advanced text,
simple text, or extended text)
o Screensaver time (measured in
minutes)
o Barcode reader enable/disable
 Communication
o Device communication (adjust
settings)
o Peer communication (adjust
settings)
 Measurement
o Units
o Normal Ranges
 Printer (printer settings)
 Date and Time (adjust settings)
6.4.2.6 Exit menu

 Shutdown
 Preparing for shipment
 Logout/Login
 User management (if Admin is logged in)
o Add new user
o Remove user
o Automatic login set
o Edit user
7 Start-up and shut down of Abacus 3CT

7.1 Turning the Instrument ON
Make sure all external devices are turned on first (printer, host computer).
Turn on Abacus 3CT using the main power switch on the

back, above the DC power input connector (see section
5.7.2).
‘On’ position is marked by the ‘I’ symbol.
During start-up, the following screen will appear.
The software comes up in the Main Menu.
If you wish to browse the database, then no further user
action is required.
If you wish to run a sample, then go to Measure menu.
Starting a new measurement will perform prime of
reagents and cleaning automatically.
After power on, wait 5 minutes before initiating any measuring process to allow the
instrument to reach optimal working temperature.
In some cases, a priming cycle is necessary prior to sample measurement. The analyzer will perform
prime cycles automatically if the fluid sensors are turned on, and additional liquid in the fluidic
system is required.
Run priming cycle in the following circumstances:
 After installation;
 After extended time out of use;
 Replacement of any component related to the Fluidic System;
 Replacement of reagents with the analyzer turned on.
7.2 Turning the Instrument OFF
Do not turn off the instrument by simply flipping the power switch on the rear panel.
Doing so, may result in erroneous operation, loss of data or prolonged start up cycle
during later use.
The built in Shut down procedure will set the analyzer electronics, fluidics and mechanics in a
definite state:
 Abacus 3CT saves data, settings, closes the databases and other files. If the power is simply
cut before all data items are securely saved, some data might be lost.
 The SW will perform cleaning to remove debris and fill chambers and apertures to avoid
clogging and contamination. Without proper shut down, blood-sample can remain inside the
instrument increasing the risk of contamination or if dried in, blood can permanently block
the sample-paths.
 The analyzer will move the mechanical parts (sample needle, syringe pumps, valves) into
their safe home positions to reduce risk of injury, and avoid more time and higher amount of
reagents during the next start-up process.
Therefore always follow the instructions below when switching the instrument off.
To shut down Abacus 3CT, press EXIT key in the Main menu. The following screen appears.
Press Shutdown.
Abacus 3CT will display a message and give a tone indicating that
it is safe to turn off power, after the shut down procedure is
finished.
Turn off the instrument using the power switch on the rear
panel. Off position is marked by ‘0’ symbol.
7.3 Preparing for shipment

User should perform Preparing for shipment procedure, before shipping the analyzer, or if it will
not be used for more than a week.
The analyzer will perform three individual cycles:
1. Drain reagents into Waste tank after disconnecting reagent lines
2. Prime Rinse reagent or DI water into reagent lines to dissolve and remove salt and reagent
residuals
3. Drain all liquids into Waste tank.
For the above procedure, please, prepare the cleaning tube kit (refer to section 4.2) and 150ml of
Rinse reagent (refer to section 5.4) or clean DI water.
To start the process, press EXIT key in the Main Menu.
Tap Preparing for shipment button.
Follow the on screen instructions:
1. Remove reagent tubing (diluent, lyse and cleaner), but
leave waste lines connected. SW will prime on air, and empty
reagent lines and syringe pumps.
2. Connect the cleaning tube kit to the reagent inputs,
submerging the free end in a bottle containing at least 150 ml of
Rinse reagent or clean DI water. The SW will prime rinse to
dissolve salt remains, and flush the fluidics.
3. Remove cleaning tube kit, leave waste connected. SW will
drain the fluidics to remove all liquids.
4. Power off the analyzer and disconnect the waste tubes.
5. Disconnect electronic connection and power supply.
7.4 Emergency shut-down

Please, refer to section 2.10 for Emergency shut-down procedures.
8 Sample Measurement
In this chapter you will find information about sample runs.
8.1 Sample Tube Support of Abacus 3CT

8.1.1 Supported Sample Tube Types
Abacus 3CT supports the following K2- or K3-EDTA, 13x75mm sample-tubes:
 Becton Dickinson (BD) Vacutainer®
 Terumo Venosafe®
 Sarstedt Monovette® (in open mode only)
Use only sample tubes with K2- or K3-EDTA anticoagulant.
You can use sample tubes from other vendors if the below conditions are met:
 It should be mechanically compatible (13x75 mm family) with the sample rotor and adapter
 It can be pierced or should be used in open vial mode
 If the bottom of the tube is lifted, adjustment of the sampling depth is necessary (see section
8.1.2 below).
It is recommended to contact your service representative before using another type of sample tube.
Although these sample tube types are designed for multiple piercing, it is recommended
to remove the cap after 3-4 piercing cycles. Small rubber bits can crumble into the
blood and adversely affect the performance of the Abacus 3CT analyzer, or it can cause
aperture clogging.
8.1.2 Sampling Depth

Abacus 3CT is equipped with a piercing needle capable of aspirating samples from closed sample
tubes. Since piercing is performed from the top, the needle goes to the bottom of the sample vial to
take sample if few blood is available in the tube.
In case of using a sample tube with a lifted bottom (such as Sarstedt Monovette®), the sampling
depth should be adjusted before pressing Run button in Measure menu.
Sampling depth can be adjusted in the following steps: -2mm, –––, +5mm, +10mm, +15mm.
Default sampling depth is: 0 mm, indicated by ‘–––‘ in the selection list, and it means approximately
3 mm clearance between the bottom of sample tube and the tip of the piercing needle.
Example to set up sampling depth correctly: if the bottom of the tube is lifted by 12 mm, select +15
mm setting to make sure the needle will not intend to pierce the bottom of the sample tube.
If sampling depth is not adjusted to the tube correctly, the piercing mechanics will try
to pierce the bottom of the tube, which may result in damage to the sampling needle, or
pneumatic error of Vertical motor.
8.2 Introducing sample, sample adapters

Abacus 3CT can process both open and closed sample tubes in the sample rotor.
There are 3 different types of tube adapters provided for sampling. Use the appropriate sample
adapter in the sample rotor: standard, microtainer or small control adapter.
The appropriate sample adapter must be selected before introducing sample into the sample rotor.
8.2.1 Standard sample adapter

This adapter is used for piercing vacutainer tubes of 13x75mm, and tall control vials.
Vacutainer with blood Vacutainer with blood 5ml control tube

(cap removed) (with cap) (screw-cap removed)
8.2.2 Microtainer adapter

Below you can see three types of microtainers used in microtainer adapters.
Turn vial so that the cap of the

microtainer gets close to the
Remove cap from microtainer. Remove cap from microtainer.
sample rotor to avoid blockage.
8.2.3 Small control adapter

Below you can see correct application of the small control adapter.
2 ml control blood – open mode only Always remove the hard plastic cap.
8.3 Sample Collection and Handling

Please consider the following when collecting and handling human blood samples:
 Make sure that the sample tube is filled to the sample level line indicated by the tube
manufacturer. The anticoagulant not only prevents the coagulation of blood, but also dilutes
it. If the volume of blood is too low, than this dilution can adversely affect measurement
results.
 Ensure that the blood and anticoagulant are properly mixed by inverting the tube at least 8
times. Do not shake the sample as this could damage blood cells and cause micro bubbles.
 A minimum of 30 minutes should elapse between taking the blood sample and running it on
the Abacus 3CT for analysis to ensure that the interaction of blood and anticoagulant has
fully stabilized. Check the data sheet of the sample tube for exact time requirement.
 Use K2- or K3-EDTA anti-coagulated fresh whole blood as sample.
 Analyze blood samples within 7 hours of collection.
 Samples should be analyzed at room temperature.
 Before running measurement, the tubes must be mixed by inverting the tubes 11 times
 Pre-diluted samples should be prepared and analyzed immediately after dilution (1 part
blood to 5 parts saline).
 Do not deliver or store the samples at temperatures above normal body temperature.
All blood samples must be handled as potentially infectious material that represent
biohazard.
8.4 Sample Types and Modes

The Abacus 3CT analyzer is designed to process the following sample types:
 Whole human venous blood to determine the hematology parameters of the blood
 Quality control (QC) materials for quality control purposes
 Calibrator materials for calibration of the primary hematology parameters
QC materials are artificially modified human and/or animal blood samples with known parameter
values. QC samples can be stored for a period of time as indicated on the control vial.
Sample mode must be selected before a measurement starts. Abacus 3CT analyzer works in the
following measurement modes:
 Blank mode: No sample has to be presented to run a blank. Blank mode checks that the
measuring system is operating correctly, it is clean so that blank results are acceptable.
 Human blood mode: Choose one of 10 human blood profiles (Human, Male, Female, Profile
1, Profile 2, up to Profile 7). Each mode has a unique set of normal ranges associated with it.
For Profiles 1 to 7 the name of profile and the normal ranges can be defined by the operator.
 Control (QC) mode: The hematological parameters of QC and control materials are known
prior to analysis. Controls are used to check the long-term stability of the Abacus 3CT
analyzer, while calibrator is used to perform calibration.
Calibration with a calibrator material is not one of the Abacus 3CT sample modes, but a specific
procedure that is accessible from the Calibration menu.
8.5 Sample Identification
Use caution and ensure accurate data entry when manually entering sample ID or
patient ID information into the user interface of the Abacus 3CT analyzer to avoid
possible misidentification of sample results.
The following sample information items are used to uniquely identify samples:
 Sample Mode (Blank, Control, Human, pre-diluted, etc.)
 Time of measurement: assigned automatically by the Abacus 3CT analyzer SW
 Sample ID: assigned by the operator – or automatically assigned by Abacus 3CT SW
o Abacus 3CT doesn’t require the sample ID to be unique
o Sample ID can submitted by:
 Manual typing
 Bar code reading (with a manual bar code reader)
 Automatically assigned by Abacus 3CT SW
o Sample ID is not applicable on blank measurements
 Patient ID: assigned by the operator by manually typing in
o Not applicable for blank and QC measurements
o Can be changed in the database later on
8.6 Running Samples

After powering up Abacus 3CT, you need to perform the following steps
in order to run samples.
Ensure that:
 All reagents and the waste are properly connected
 All environmental conditions are met
 Blank measurement has been run and accepted (see section
8.6.1 below)
 Quality Control material have been tested and produced
acceptable results, so that calibration of the analyzer is valid
(see chapter 12)
 Specimen is ready to use, mixed well and it is in the
recommended time for measurement (see section 8.3)
8.6.1 Running Blank measurement

There must be an accepted Blank measurement performed before running controls, calibrator or
patient samples.
Blank measurement must be performed:
 Before sample analysis starts, and at the beginning of every shift
 If the analyzer was not used from more than 3 hours
 After any reagent replacement or service/maintenance operation
In Blank measurement mode, the analyzer will perform a measurement cycle without sample to
check cleanliness of the analyzer. After this cycle the Blank values are displayed.
Follow the process below to run Blank:

 In the Main menu select Measure, then New Sample
 Press Blank to perform a blank cycle
 After 1 minute, the analyzer will display Blank values
Blank results screen will appear.
Blank values ranges:

Parameter Acceptable Blank range
HGB 0-1 g/dl
WBC 0-0.5 x103 cells/µl
PLT 0-25 x103 cells/µl
RBC 0-0.05 x106 cells/µl
If the blank values are within the above ranges, press Accept
to store the blank values.
If one or more parameters are out of range, repeat Blank
measurement 2-3 times, by pressing Re-blank key.
If the Blank is stable high for certain parameters, run Cleaning
or Hard cleaning in Maintenance menu (refer to section 11.1).
Press Print to print blank results.
Press Back to return to measure menu.
8.6.2 Patient Sample Run

There must be an accepted Blank measurement performed before running samples (see section
8.6.1)
Follow the process below to run patient samples:
 Mix the sample gently but thoroughly by inverting the
sample tube 8-10 times (refer to section 8.3).
 In the Main menu select Measure, then New Sample
 Insert the applicable adapter into the sample rotor
 Open the tube if necessary
 Put the sample tube into the adapter
 Adjust sampling depth if needed (see section 0)
 Select sample profile (Human, Male, Female, Profile 1..7)
 Select Pre-diluted mode if needed
 Select Small Sample mode if needed (open vial)
 Identify the sample (sample ID) either manually or by
scanning the barcode. Refer to section 8.5
 Push Run key on the display.
The sample rotor will turn in and the needle aspirates 100 µl of
sample from the tube. Then the sampling needle is retracted,
while its outer surface is automatically rinsed with diluent.
After a few seconds, the sample rotor turns out.
 Remove the sample tube from the adapter.
If there was no Blank measurement performed before, then the SW

will display the following message. Press OK to measure Blank.
After 1 minute the analyzer will display the results.
Measurement results screen:
You have the following options:
 You can print the results by pressing Print button.
 Return to measurement panel by tapping Back button.
 Run a new sample by pushing New sample button
 Re-run the previous sample with the same sample ID by
pressing Re-run button
 Discard the measurement record if you made a mistake,
or error is displayed. Press Discard button, and the actual
measurement record will be deleted from the Database
Please, refer to Chapter 9. for result interpretation, and
understanding flagging.
Do not reach inside the instrument during

piercing because the needle can cause injury.
8.6.3 Remote work list (EMR) mode

If Remote work list was transferred to the Abacus 3CT from
LIS (laboratory information system), then this work list is
available in Measure menu after pressing New sample.
Press EMR(LIS) to see the work list of samples to be
measured:
Select sample ID to measure that sample, or scan the bar code

of a sample from the list to automatically set Sample ID and go
to run mode.
Press Run to measure EMR (remote) sample.
8.6.4 Pre-diluted Sample Run

This mode allows the operator to measure CBC results on samples having only small volumes, or
when some parameters are out of the linearity range.
Sample must be diluted manually in an appropriate, clean sample tube with physiological saline at a
ratio of 1 part blood sample to 5 parts clean saline. It is important to ensure there is a sufficient
final volume in the tube to enable the analyzer to aspirate the diluted sample satisfactorily.
The suggested minimum diluted sample volume is 300 µl for a Vacutainer sample tube.
When the pre-dilute mode is selected, all results are automatically corrected and calculated for the
dilution factor of 1:6. Please, refer to Pre-diluted calibration in section 11.2 as well.
Make sure to use physiological saline and not diluent to prepare diluted samples,
otherwise
some parameters may change due to the stabilizing effect of diluent.
Follow the steps below to run pre-diluted sample:

Prepare a diluted patient sample at a dilution ratio of 1:6 (1
part blood to 5 parts saline) using physiological saline.
Please ensure that the sample is well mixed and measured
on the analyzer immediately after preparation.
 Go to Measure menu, press New Sample
 Tap Prediluted box on the screen to
change it to YES.
 Tap Sampling mode menu to enable the
small sampling option.
 Place the diluted sample into the
appropriate sample adapter
 Initiate the measurement by pressing Run
button.
 Analysis will take place. CBC results are
corrected for the dilution factor, and displayed on the screen
and can be printed.
 Remove sample when prompted.
8.6.5 Small Sample Mode (SSM)

This feature enables to take 25µl of whole blood sample from open vial only. This is a low sample
volume-measuring feature. This feature can be enabled by Service personnel and has to be selected
before every sample run in sample run menu. The needle will take precise 25µl whole blood from
the sample vial and directly transfer it to the MIX chamber for dilution.
To select the SSM mode tap on the sampling mode option and change Normal sampling to Small
sampling, if enabled.
SSM mode can calibrated only by service person on service level.
8.6.6 Control Runs and Control Bar Codes

Abacus 3CT offers Control measurement in Measure menu by selecting measurement type as
Control.
With an optional data-matrix bar code reader, the operator can read the
bar code of the Control vial and the system will recognize it, if the actual
Control LOT has been already read in as quality control material. In this
case the QC measure menu will pop-up and the operator only has to tap
Run to initiate control measurement.
Refer to section 12 for details on Quality control functions.
9 Interpretation of Results
This chapter provides description about interpreting and understanding results and flags.
9.1 Results Screen

Result screen of Abacus 3CT is displayed in 3 separate screens, where the header will be the same.
9.1.1 Parameter screen

In Parameters screen the Parameters tag is highlighted. There are three major sections.
Sample identification header with:
PID – patient ID, date and time of sample run,
SID – sample ID and sample Type (Human in this case)
WARNING – flags will be shown, LYSE setting, Pre-diluted
and Needle settings will also appear here.
Parameters measured:
Parameter names, values, units, and evaluation if those are
lower, inside or higher than the normal range.
Values within the normal range are displayed in white, and
outside the normal range are displayed in red, and flagged:
L – if lower than the normal range, or
H – if higher than the normal range specified by the
measurement type.
Histograms: Graphical information about volume distribution
of WBC, RBC and PLT. Histograms indicate discriminators by
vertical lines that separate different cell populations.
9.1.2 Normal ranges screen

Pressing Normal Ranges tag brings up this screen.
In normal range screen: in place of the histograms on the
right, normal ranges will be displayed in a graphic format.
Each value will be indicated by positioning a white arrow
within the normal range graphics.
Low and high limits of the normal range are displayed on the
two sides of the line. If the value is out of normal range, the
line is red, otherwise it is shown in green.
If a parameter has no normal range defined then no normal
range graphics will appear.
9.1.3 Technical details screen

Pressing Tech Details tag below the sample ID header, the following technical details screen
appears.
Probe voltage:
This section shows electrode voltages for WBC and RBC
counting, min. and max. values, for service purpose only.
WBC lyse volume: 0.9 ml.

It shows amount of lyse used for the measurement. Lyse
setting can be modified by the user before measurement run.
See section Hiba! A hivatkozási forrás nem található. for
details on lyse volume setting.
Diagnostic flags: This area shows evaluations made by the

analyzer SW based on the results. There may be numerous
diagnostic flags and suspects appear here.
Warning flags are displayed for the measurement. See

section 9.2 below for details on warning flags.
9.2 Parameter Flags

This section describes diagnostic and warning flags indicated by Abacus 3CT.
9.2.1 Out of Normal Range flags

The first flagging method is evaluation against the normal
ranges.
If a parameter is out of range, it will generate:
 L flag if under the normal range, or
 H flag if over the normal range.
In addition, the flagged parameters are highlighted in red.
The operator can establish normal ranges for each Profile
provided by the software. (Refer to section 14.3.2)
If 0 (zero) value is set for range limit of a parameter, it will not
be verified, and no normal range graphics will appear behind
it.
9.2.2 Measurement condition flags

If the instrument cannot interpret measurements appropriately, measurement condition flags will
be attached to the result. These flags are displayed in the header of the results screen, after
‘Warning’, and appear in Tech. details screen in the lower section, with a short explanation.
9.2.2.1 Flagging on WBC and HGB channels

Uppercase letters refer to WBC or HGB flags.
Flag Meaning Explanation, recommended user action
No WBC 3-part  Possibly lyse problem, or sample was inadequate. May also occur in
E
differential pathological lymphocytosis. Rerun sample, making sure it is enough.
3-part differential  Possibly lyse problem, or the sample is more than 7 hours old.
W warning  Run prime lyse, and rerun sample.
HGB blank is high, or  Repeat blank measurement. If HGB blank is still not stable, there are
no HGB blank probably bubbles in the WBC chamber. Run prime lyse, run cleaning
G
and try blank again. Close the side door if open during
measurement.
WBC blank is high, or  Possibly lyse contamination, or noise problem. Repeat blank
B
no WBC blank measurement, or run prime lyse and try blank measurement again.
WBC clogging  Aperture clogging. Perform cleaning or hard cleaning and rerun
sample. If this flag persists, please, contact your Service Personnel.
C
 Low temperature reagent can cause it as well (mainly diluent), in
this case, you will have to wait until they reach room temperature.
WBC coincidence is too  Rerun sample in pre-diluted mode. See section 8.6.4 for details.
M
high. Linearity error.
WBC/RBC threshold  The RBC-WBC discriminator is over 45 fl on the histogram.
D Interference  Rerun sample with higher lyse volume setting.
Tip: Flagged results should be repeated.
9.2.2.2 Flagging on RBC/PLT channel

Lowercase letters refer to RBC/PLT flags.
Flag Meaning Recommended user action

PLT blank is high, or Run cleaning or Hard cleaning and repeat blank measurement.
no PLT blank Diluent or system cleanliness problem. Check for bubbles at reagent
p
inlets, and prime diluent. If it is stable high, replace the diluent by
opening a new tank.
RBC blank is high, or no
b Same action as in case of warning flag p.
RBC blank
c RBC/PLT clogging See remedial action above described in case of warning flag C.
RBC/PLT coincidence is Rerun sample in pre-diluted mode. Refer to section 8.6.4 for details.
m
too high. Linearity error.
RBC/PLT threshold The analytical software could not separate RBC’s from PLT’s
d Interference because of a population overlap. Possibly clumped PLTs.
Tip: Flagged results should be repeated.

9.2.3 Warning flags of Differential Parameters

If the following flags appear at differential parameters, see Possible indication column for suspect.
Parameter Flag Flag type Flag Description Possible Indication

Lymphocytosis;
LYM cell
LYM% H Distributional Variant lymphocytes;
population > 46%
Chronic lymphoid leukemia;
LYM cell Lymphopenia;
LYM% L Distributional
population < 11% Chemotherapy; HIV
Abnormal WBC cell types;
immature granulocytes; blasts;
basophilia, monocytosis,
MID cell esosinophilia;
MID% H Distributional
population >17% Chronic inflammation;
Leukoerythroblastic pattern if
combined with a “d” or “D” region
interference flag.
Granulocytosis;
GRA cell left shifted myeloid maturation
GRA% H Distributional
population > 81% (Bands);
Bacterial Infection
Granulopenia;
GRA cell
GRA% L Distributional Acute leukemia;
population < 44%
Viral infection
Interference
Region WBC fragments;
N/A D between PLT and
Interference RBC agglutination
WBC population
Interference Nucleated RBC’s;
Region
N/A d between PLT and Giant platelets;
Interference
RBC population Platelet clumps
9.2.4 Blank measurement flagging

Parameters will be flagged if the operator accepted high Blank value. In some cases the associated
parameter is flagged, but in other case it is dashed out. See details below.
Parameter Value is displayed Value is dashed out ‘–––‘

but flagged by ‘* ‘ and flagged by ‘E’ (error) flag
HGB 1 – 2.5 g/dl > 2.5 g/dl
WBC 0.6 - 1.0 x103 cells/µL > 1.0 x103 cells/µL
PLT 26 - 50 x103 cells/µL > 50 x103 cells/µL
RBC 0.06 - 0.5 x106 cells/µL > 0.5 x106 cells/µL
Tip: Perform cleaning, and run Blank measurement again to correct blank measurement flags.
9.3 Known Limitations in WBC Differentials

 Each laboratory is responsible for establishing its own protocols for addressing flags.
Abacus 3CT classifies cells based on size differentiation only and does not have the
capability of flagging specimens with morphologic abnormalities of any of the particular cell
types.
 Due to the limited performance characteristics of Abacus 3CT, some abnormal cell types that
are present at low frequencies (e.g. ≥1% leukemic blast or plasma cell, >5% atypical
lymphocytes, >2% metamyelocytes, ≥1% myelocyte or 1% promyelocyte or a few blast
abnormalities in the absence of a leukocytosis or lymphocytosis) are not likely to be
identified.
 Abacus 3CT does not have the resolution to flag atypical lymphocytes or abnormal
lymphocytes from normal lymphocytes, based strictly on size differentiation.
 Nucleated RBCs are not classified or flagged by the Abacus 3CT analyzer.
10 Database Operations
Patient results are stored in the analyzer’s memory in chronological order, and can be viewed in the
database at any time.
Memory capacity is 10,000 patient records, including all parameters, histograms, flags, sample ID
and date/time of measurement.
If storage space is full, the latest (actual) record will overwrite the oldest record in the Database.
10.1 Main database menu

To access Database table, press the Database icon in the Main
Menu. This will display a main database screen, which allows
selecting stored results for further operation.
All records can be selected/deselected by pressing Select all
button on top of the screen.
Selected state is indicated by a filled (yellow) circle in front of
each record. Press this button to select/deselect that record.
The top indicator is active if at least one record is selected.
Use the ⇧ and ⇩ keys to browse within records, and tap ⇦ and ⇨
to browse between parameters columns.
Details button allows the user to view results with
histograms, the same results screen like after measurement.
Total number of records, and the number of selected records are
displayed below the list.
If more than one records are selected, the Statistics button will
be activated, and the SW will be capable of calculating statistics
of the parameters (mean, SD, CV, Levy-Jennings chart).
Print will start printing selected records on the actually selected printer.
Filter button allows searching/selecting records by specific criteria.
Manage button allows the user Delete, Send, or Backup selected records.
Back button will return to Main menu.
10.2 Database detail view

Pressing Details button in Database menu will show the actual or the first selected record.
The user can switch between Parameters, Normal ranges and Tech details views by pressing the tag.
10.2.1 Editing stored records

In database detail view certain data fields of the database records can be edited/updated.
Sample ID, Type of measurement, Prediluted mode, Lyse settings,
and Sampling depth cannot be modified. Those are indicated by
shaded box.
Patient ID, Name of patient, Birthdate, Sex and name of Doctor
can be modified.
Pressing the white box of the data field, an on-screen keyboard
will pop up (see screen below).
After making all modifications, press Accept to save changes and
return to Details view.
Press Cancel if you wish to exit by discarding all changes made.
This screen shows an example of on-screen keyboard when

entering the Name of the patient.
The field identifier (Name) appears in the header of the
keyboard pop-up menu item.
Type in the desired data, and press Enter to save changes.
Use Shift to toggle between uppercase/lowercase characters.
Use Del key to delete the last character.
Press Cancel to discard changes and return to previous
screen.
10.3 Filtering and Selecting records in database

Data records can be selected either individually by pressing the selection button in front of the
record, or by using Select in Filter function. Result filter helps filtering the database for further
operations.
Press Filter button in Database menu to access Result filter
function.
Stored records can be filtered/selected by the following
criteria (see screen for further details):
 Measured between specified dates (date from/to)
 Patient ID
 Sample ID
 Type of measurement (Human, Blank, etc.)
 Records: All/Selected settings only
The default setting for the date is the actual date. Pressing
Clear will delete dates and restore default settings.
Press Select button to select the records that meet the
criteria or press Filter button to filter those records from
database that meet the criteria.
Press Cancel to return to main database menu without
changes.
A numerical input pop-up screen will appear after pressing

e.g. Date to field.
Type the desired date and press Enter. ‘/’ character will
appear automatically. Use Delete to delete the last character.
Press Cancel to discard changes.
Data input is similar for Patient ID and Sample ID fields as
well.
Selection on filtering can be applied on the whole database
(All) or on the already Selected records only. Push the
Records field to toggle between these two states.
Press Type field if you wish to filter/select based on type of
measurement. The following selection screen will appear.
Push the desired type of measurement, or push All.
Database main menu after filtering records:
After filtering or selecting records, the number of filtered

and selected records will appear in the database main menu.
In this case, filtered records will be shown in the list only.
10.4 Managing selected records in database

After selecting records in database main menu, press Manage to select from the operations below.
By pressing Delete, selected records can be deleted.
Send button can be used to transmit selected records to

external computer or laboratory information system (LIS).
Backup button will open back-up options menu. Selected

records can be saved in different file formats onto USB mass
storage device connected to the analyzer, such as a USB pen
drive.
Press Back to return to Database menu.
10.4.1 Deleting selected records

Pressing Delete button in Manage database menu will
delete records selected previously.
Since deleted records cannot be restored, the SW will ask
for confirmation with this screen.
Press OK to proceed, or Cancel to return without deleting
records selected.
10.4.2 Sending selected records to computer or LIS

It is possible to send selected records to a connected computer or laboratory information system
(LIS). There must be a hardware connection already established between the analyzer and the
external PC or network. For details on setting up communication link, please, refer to Section 0.
After selecting records in database main menu, press Manage
and tap Send button to transmit selected records to external
computer or laboratory information system (LIS).
Send menu will appear, to select from connections enabled.
Select the connection to send the selected records to, or press
Cancel to cancel the operation.
On the Send screen select:
 PC to transmit
selected records to a PC via Ethernet channel
 EMR to upload the
selected record to a PC or LIS connected via Ethernet port,
as remote work list was previously downloaded from LIS
to Abacus 3CT
 USB-Serial to use PC
link via USB-B port connection, and serial communication
protocol.
After selecting the communication port, a progress bar will

appear, showing the link as the selected data are being sent.
Press Abort to stop sending the data record, and return to

Manage menu or wait until transmission is over.
10.4.3 Backup of selected records

Tapping Backup button in Manage database menu will open backup options menu.
Before proceeding with backup function, insert a pen

drive into one of the USB ports.
Select one of the Backup options below:
 Save: to save selected records in .db format. Data saved
in this format can be viewed later using Backup view function.
 Export: to export selected records as .txt file. In this
ASCII format, data can be easily imported into Excel and other
programs.
(Refer to section 14.1 to set up format of text exported to file.)
 Backup view: function will open
.db format data files previously saved onto a pen drive. See
section 10.4.4 for details.
 Backup one day: function will
allow you to backup data record of a specific day in .db format.
See section 10.4.5.
Press Home to go to Main menu.
Press Back to return to Manage menu.
If Save or Export functions are selected, the following

progress bar will appear during file saving, indicating the
name of the file being saved.
Wait until the save operation is completed (progress bar is

over), check the pen drive if there is further activity (LED
flashing).
Remove pen drive from USB port if no activity detected to

avoid data loss.
10.4.4 Backup view function

This function allows the operator to retrieve saved records
database and view the data records on the display.
Data opened in backup view mode can be, selected, printed or

transmitted.
 Insert the pen drive containing saved data record

database in .db file format.
 Tap Backup view in Backup menu.
 The analyzer will list saved database files found.
 Select the one to open and press OK.
After opening the record database from pen drive, the following menu appears. The header will
show the file name.
Individual records can be viewed by Details button.
Records loaded from the USB storage device can be viewed,

printed, filtered, managed, and statistics calculated just like for
normal database records.
See Chapter 10 for details on database functions.
Tap Back to return to Backup menu.

10.4.5 Backup one day

Use this function if you wish to save records of one particular day
from the database.
Tap Backup one day button in Backup menu, and follow the steps
below:
 Connect a pen drive into a USB port.

 Tap the white Date field and enter the date you wish to save.
 Press Enter, then tap Accept. The SW will save data records
in .db (database) format.
Press Cancel to return to Backup menu without saving data onto

the pen drive.
10.5 Statistics of selected records

Abacus 3CT SW can calculate and display statistics on selected sample records. In main database
menu select the records to calculate statistics on. Refer to sections 10.1 and 10.3.
Tap Statistics button. A Levy-Jennings chart will be displayed.
Data of each measurement record will be displayed in graphics.

The SW will calculate N (number of data points), CV (coefficient
of variance), SD (standard deviation), and MEAN of data points.
Use ⇦ and ⇨ keys in the bottom of the screen to move between

previous/later data points indicated by the white pointer.
Press View button to view details of the actual data point
indicated by the arrow white pointer.
Use ⇧ and ⇩ in the bottom of the screen to browse between

parameters.
Press Print to print tabular or Levy-Jennings charts.
Press Back to return to main database menu.

10.6 Printing selected records

Pressing Print key after selecting samples, the following
option screen pops up.
Press Result by result to print
normal report format.
Press Table format to print a
summary of records without
histograms.
Press Cancel to cancel printing.
There will be a progress bar displayed during printing.
The operator can abort printing by pressing Abort key.
Refer to chapter 18 for available printing formats.
10.6.1 Handling print jobs

If printing is started but not finished due to an error situation (no connection to the printer or
printer is out of paper), the analyzer will show an error icon
in the header.
Push this icon to open the Print jobs menu.
Print jobs screen (indicated on the left) will show the actual
printer status and list of printer jobs pending.
The operator can Abort current job to cancel current

printing, and Abort all to delete all printing jobs from the
printer queue.
Press Back to exit this menu.
11 Maintenance menu
Maintenance icon allows access to Cleaning, Calibration,

Diagnostics, and Reagent Status menus.
11.1 Cleaning
Cleaning: Starts a wash cycle using the cleaning reagent
connected to cleaner input. A cleaning cycle is automatically
performed during a start-up and a shutdown procedure.
Hard Cleaning: It must be performed weekly as part of

routine maintenance. Clogging errors or high PLT blank
indicates the need for additional hard cleaning.
The SW will prompt to insert the HypoClean CC solution (see
in section 5.4) into the sample rotor using a sample vial.
Drain Chamber: Used during troubleshooting or component

replacement only. Drain of the chamber should be run before
removal or replacement of parts related to the measuring
chambers or apertures (Service personnel task).
11.2 Calibration Menu

From the Calibration menu, the operator can initiate
calibration of Abacus 3CT or can review calibration history.
Prior to Calibration, a Self-Test and a Blank Measurement
must be performed with acceptable results.
Calibration is required at installation, or when the control
values are out of range.
Press Factors to check or modify Calibration factors
manually.
Tap Database to see calibration database.
Push Calibration with measurement to run calibrator.
Tap History to see history of calibration events by factors.
Pressing Prediluted enters to Prediluted calibration menu.
Prediluted calibration factors are used to calulate results
measured in Pre-diluted mode. Refer to section 8.6.4 for
details on pre-diluted sample mode.
11.2.1 Calibration Factors menu

This menu allows the operator view or modify the actual
calibration factors.
Tap the white box of a factor to enter a new value.
Press Accept after all modifications are made to save the new
factors. This will generate a new event in the calibration
history log, with the current date and time, by storing the new
factors. See calibration history in section 11.2.3.
Press Print to print the factors.
Press Cancel to discard changes and return to Calibration
menu.
11.2.2 Calibration with Measurement

In Calibration menu, select ‘Calibration with Measurement’
menu.
If you have a 2D bar code reader connected, simply scan the
2D (Q-R) barcode on the assay sheet of the control to upload
lot number, expiration date, and target values for the
calibration material.
In the absence of a bar-code reader, enter these values
manually, one after another by tapping on the value boxes.
Select the number of calibration runs desired (3 or 7).
If you wish to calibrate pre-diluted mode, then prepare pre-
diluted calibrator, and set Prediluted mode to YES.
Select sampling depth based on the vial used, or leave it in
default ‘––– ‘ (= 0 mm) setting. See section 8.1.2 for details.
Tap Accept to proceed to run calibrator, or Cancel to exit
without calibration.
If Accept is pressed, the analyzer will save the target values
and proceed to calibration measure screen.
Mix the calibrator thoroughly, insert it into the sample
adapter and press Run.
After calibrator measurement is complete, the results will
be displayed.
If the results look good, and there are no warning flags
displayed, Run calibrator again until the preset number of
runs (3 or 7) is reached.
If warning flag was received (‘C’ or ‘c’ meaning clogging,
etc.), press Discard to delete that particular calibration run
and Run calibrator again.
After performing the last run, the Calibration results
screen will appear, as indicated below.
A statistical evaluation of calibration results will appear.

Target values, means of runs, CV% and the new calculated
factors will appear (see screenshot to the left).
If CV% (coefficient of variance) values and the new factors are
satisfactory, press Accept to save the new calibration factors.
Each calibration factor must be within 1.00 ± 0.20 limits.
If a calibration factors is outside this range, it will be highlighted
by red.
Press Cancel if you do not wish to modify calibration factors.
 If results are not acceptable, repeat the calibration process
using a new vial of calibrator material.
 If it is still not acceptable, call Technical Support.
11.2.3 Calibration History and Calibration Database

In Calibration menu both the Database and History menus contain historical calibration
information.
 Database contains the details of each calibration run.
 History menu contains the calibration factors generated with each calibration.
11.2.4 Pre-diluted Mode Calibration menu

In Calibration/Prediluted menu there are two options.
In Factors menu, the operator can check and set up the
calibration factors used for pre-diluted sample runs.
In History menu the history of the pre-diluted calibration
factors can be reviewed, just like for normal calibration
factors.
Tap Home to return to Main menu.
Press Back to return to Calibration menu.
Prediluted calibration factors and history menus. See sections 11.2.1 and 11.2.3 for details on use.
11.3 Diagnostics menu

Diagnostics menu contains Device Information, Statistics,
and Self test submenus.
Select the desired submenu.
Tap Home to go to Main menu, or Back to exit to
Maintenance menu.
11.3.1 Device Information

Device information includes the Model, Serial Number, SW
version, PIC version, and SW Compilation date, as shown
below:
11.3.2 Device statistics

Device statistics show statistics of measurement cycles, errors, and other technical information.
Press Back to return to previous menu.

11.3.3 Self-test
Run self-test to verify operation of essential components of the
analyzer.
Self-test should be performed:
 After installation.
 After replacing any component.
 After extended time not in use.
 If you have any doubt that the analyzer is not reliable.
When self-test is finished, Abacus 3CT displays a summary of
the results: Success or Error. The results should fall within the
ranges specified by the Min. and Max. values.
Tap Save if you wish to save the results onto a USB pen drive.
Press Print to print self-test results.
Press Start to start self-test again.
If any of the self-test parameters fail, contact your

Press Back to return to Diagnostics
local service representative.
menu.
11.4 Reagent Status

This menu helps monitoring reagents, set up and check lot numbers, expiration date, and actual
level.
There are individual sensors for the three reagents, which can be
turned On/Off by switching the sensor icon by pulling left/right.
For priming press Prime at the selected reagent, or Prime all to
prime all reagents. Reagent sensors will control priming.
Go to Replace menu, if you wish to replace one or more reagents.
Waste and reagent level % calculation is based on the setting of
the tank capacity. Use Volume key to set up capacity of tanks.
If you receive reagent sensor error messages, then run Calibrate
sensors to reset sensors (see section 11.4.4 below).
Tapping View log will show reagent replacement history.
Tap Measurement credits to check measurement credit counter
(see section 11.4.3)
Pressing Empty Waste will restore Waste counter to 0%. Make
sure to dispose of the contents of waste container.
11.4.1 Replacing Reagents

Follow the steps below to replace reagents. The SW will record reagent replacement events.
 From the Main Menu select Maintenance/Reagent Status, then
press the Replace button at the bottom of the screen.
 Touch the white box of Reagent type and select the reagent
to be replaced from the drop down menu that opens.
 Type in the Lot number and the expiration date.
 If you replace Diatro.Lyse-Diff, then insert the reagent HK
into the ‘HW key for reagent’ slot on the back. See section 11.4.2.
 Press Accept to complete the replacement or Cancel to exit.
 Repeat the above process for the all reagents to be replaced.
When you push Accept in case of Diatro.Lyse-Diff reagent, the

instrument will look for a reagent key (HK). This key must be
inserted into “HW Key for Reagent” slot at the back of the analyzer.
11.4.2 Reagent Lock System

Abacus 3CT is equipped with a Reagent Lock System to prevent use of inappropriate or bad quality
reagents, and in order to provide the best results possible.
Reagent Lock System is based on number of measurement credits, which is factory set to 900. By
running each measurement, the number of credits is decreased by one. If the number of credits
reaches 0 (zero), the analyzer will not perform more measurements, but displays an error message.
To restore measurement credits, reagent hardware key (HK) must
be introduced.
Packaging of each DiatroLyse-DIFF reagent comes with a
hardware key (HK) containing 900 measurement credits.
See section 5.3 for picture of D2011HK reagent with HK.
Figure 10. Hardware Key (HK) of lyse reagent
Follow the steps below to load the measurement credits

from the HK module to the analyzer:
1. Remove HK from the zip bag of a new DiatroLyse-
DIFF reagent.
2. Plug the Hardware Key into the HW key connector on
the back of the Abacus 3CT in the way indicated by the
picture to the left.
The golden connectors of HK should face downwards.
4. In Maintenance/Reagent Status menu perform a Replace function after selecting DiatroLyse-

DIFF, and press Accept.
5. All measurement credits will be moved to the analyzer, while the credits will be deleted from HK.
6. Remove the HK from the Reagent Lock connector. This reagent HK cannot be used again.
Do not connect the reagent Hardware Key into USB ports, because the analyzer cannot
read the credits via USB. Use the ‘HW Key for reagent lock’ connector on the back only.
Failure to insert the key, or if a used key is inserted, or a

key that is not compatible with your analyzer, the
following error message will message will be displayed.
If this happens, insert a good key and press Retry.
All measurement cycles will decrease the number of measurement credits, except for
initialization, standby and wake up cycles.
Counting of measurement credits is connected to lyse reagent.

It is possible that lyse still remains in the reagent container when the counter gets to 0.
This is caused by the extra amount of lyse in the lyse container to make sure that lyse will
be enough for extra maintenance and/or service procedures.
11.4.3 Measurement credits menu

This menu is available from the Reagent status menu, by tapping on Measurement credits.
With this function the Available number of measurement on
the reagent HK and on the instrument can be displayed.
The SW will read the number of available credits from the
instrument and from the HK module connected to the
analyzer.
950 is the max. limit of the measurement credits on the instrument, so it makes no sense
to load the credits of more than 1 reagent HK at once. Measurement credits above 950 will
be lost, and the number of credits on the HK will be deleted.
Example: if there are 100 remaining measurements on the analyzer, and the operator connects and
uploads the content of a new HK (900 credits), then there will be 950 measurement credits on the
analyzer, and all credits deleted from HK.
11.4.4 Liquid sensors

Abacus 3CT is equipped with four liquid sensors. Three of them are used to check Diluent, Lyse, and
Cleaner reagents and can be turned On/Off in Reagent status menu.
The 4th sensor is built into the sampling head and checks aspiration of blood sample. If this sensor
detects bubbles during sampling, an error message will appear after measurement.
Monitoring the reagents with liquid sensors reduces the risk of performing a measurement without
adequate amount of reagent and blood sample.
You can perform measurements (human sample, QC, calibration, blank) only if all the
liquid sensors are turned on (enabled), i.e. their check boxes are ‘On’.
If one or more sensors are disabled, the operator can perform maintenance sequences only.
Turn off (disable) one or more sensors and perform the related maintenance operations if:
 There are micro bubbles in the tubing of Abacus 3CT. Check the tubing connections at the
reagent containers, the pick-up tubes and at the back of the unit. Correct/reconnect tubing if
needed.
 Some contamination dried or accumulated in a position that it blocks the sensor. In this case
the sensor always incorrectly detects liquid. Turn off the affected sensor(s) and perform
cleaning/hard cleaning sequences until the contamination is removed and the Abacus 3CT is fully
operational again. Afterwards enable all sensors again and run Calibrate sensors.
 If the service person instructs you to do so. In this case, follow their instructions.
Use Calibrate sensors function to start a procedure to readjust trigger/threshold setting of the
liquid sensors.
11.4.5 Reagent log menu

From the Main Menu select Maintenance/Reagent Status, then press the View log button at the
bottom of the screen.
By pressing Filter button the operator can select which reagents to
show in the log:
Press Export to save Reagent change log on a USB pen drive as file
“reagent_tracking.csv” in ASCII format. It can be opened in Excel.
Press Print to print reagent log.
Tap Back to return to previous menu.
12 Quality Control (QC) Menu

Quality control menu allows the operator to monitor day-to-day reproducibility, and accuracy of
Abacus 3CT. Before performing QC measurements the target values and tolerance ranges for each
parameter must be entered for the QC material (control blood) you wish to use.
Target values and tolerance ranges are listed on the assay sheet of the QC material.
Target values of the control material should be set only once, when you start using the
given lot. Resetting parameters deletes previous QC results of that level.
Any change in the QC material setting deletes previous QC results. It is strongly
recommended to print QC results prior to changes.
In QC menu the operator can enter a new lot of controls (by scanning the barcode, loading from data
file or by entering the assay data from the assay sheet manually), review data of previous control
lots, and print Levy-Jennings graphs. For instructions on running QC samples, refer to Chapter 8.
Always follow the manufacturer’s instructions for warming and mixing of the QC
material before use. Instructions are listed in the package insert instruction sheet.
Keep track of the expiration date and open-bottle stability of the QC material.
Most QC materials (controls) are shipped with non-piercable hard caps. Please, remove
the cap before running the control.
12.1 QC database
QC database contains the results of the QC measurements in both
table and Levy-Jennings formats.
To access a QC Database, select the Quality Control in Main Menu.
All QC files will be displayed (as shown on the left).
Use ⇧ and ⇩ to browse up/down in the list.
Select the lot number by tapping the circle in front of the lot
number, and tap to display Levy-Jennings chart.

Press New lot if you wish to enter a new control lot.
Monthly view brings up this screen for selecting month by
tapping on ⇦ and ⇨ in the header:
After selecting QC lots, Delete will delete all data related to the selected QC lots, Print will print,
Export will save data onto a USB pen drive.
Press Back to return to Main menu.
12.1.1 Entering New Lot of QC material

In the Main menu/Quality control menu press New lot.
New lot input menu brings up.
Enter the lot number of the new lot of control material by
pressing LOT box (e.g. B053), and press Enter.
If you have a 2D (Q-R) bar code reader connected to the
analyzer, then target values and tolerance ranges can be read
from the Abacus 3CT assay sheet, by scanning the Q-R code (see
example below):
If you have a target value file on a USB pen drive for this lot,
then connect the pen drive and press Load button. Contact
your local service for proper data file (e.g. ‘B053.ini’).
Select Level as Low, Normal or High, and the correct expiration date. Type in target and range
values manually.
When finished, press Accept to save QC lot data, or Cancel to return to previous menu without
saving changes.
12.1.2 Levy-Jennings QC chart

Levy-Jennings charts are displayed after selecting a control lot
in Main menu/Quality control and pressing ⇨ arrow.
Measurement points are indicated as white ‘o’. The mean and
the specified range are displayed on the right for each
parameter. If a result is out of range it is marked by a red ‘x’ on
the chart.
Press Print to print table or Levy-Jennings charts.
Use ⇦ and ⇨ to move between data points.
Press View to see the measurement results screen for the
actual data point.
Use ⇧ and ⇩ to browse between parameters.
Tap References to show reference values.
Press Database to see the QC measurement results in database
view. Refer to Chapter 10. on database options.
Press Measure to start a new QC run of the selected lot, indicated in the header.
13 Multi-User Mode
Multi-user mode provides the clinical laboratory manager the means to control access to the Abacus
3CT analyzer by ensuring that only authorized users can operate the analyzer. With the multi-user
mode, the laboratory manager can assign some users the authority to perform critical system
functions such as maintenance and calibration, and restrict other users to routine activities such as
running samples.
13.1 Types of Users

Multi-user mode provides three types of users:
 Admin (administrator) users have access to all system functions.
 Advanced user can access all functions, except for setting up users.
 Basic users can run samples, but cannot perform calibration and system settings.
13.2 Logging in
The operator has to log in using its password in order to
use the analyzer. Users can be set up by the person having
Admin access to the analyzer.
In Exit menu, press Log in to start log in.
In order to manage users, Admin level of user has to log
in.
The default Admin password is ‘0’ (one zero character).

If Multi-user mode is used, it is strongly recommended to change the Admin password,
so that no one can manage the user privileges without knowing the new password.
Log in screen will appear.

Tap the box over Login name to select from available users,
enter the password, then press Enter.
If you are logged in as Admin, then in the Exit menu User
management menu will be available, otherwise Logout
only.
13.3 User Management

After logging in as Admin user, the User management menu
is available to set up and modify users.
Tap Add new user to set up a new user account.
Press Remove user to delete an existing user account.
Tap Automatic login set, to set up automatic login option.
Tap Edit user to modify an existing user account.
13.3.1 Add new user

Use this menu to set up new user accounts and privilege
levels for multi-user mode.
Tap each box to modify its contents.
Login name will appear in the Log in box to select from.
Password should be entered and re-entered for security
reasons. This password must be entered by the user
selected for the log in name.
User type should be selected: Admin, Advanced or Basic.
Refer to section 13.1 for details on user types.
Additional data fields, such as name, phone, email can be
entered for each user as well.
Press Accept to save the new user account.
Press Cancel to exit without saving.
13.3.2 Deleting or Editing Users

Edit user and delete user menu will bring up selection menu and allows deletion or editing of user
data, such as User type, name, Log in name and password.
13.3.3 Automatic login set

If automatic log in feature is set for any of the existing users, the analyzer will log in into that user.
Log in as Admin and press Automatic login set. The following menu
appears.
Select the user account for automatic log in.
By tapping Automatic login off the operator can turn off this
feature, then the analyzer will start with the Exit menu to start
with Log in.
Be careful to set Admin as automatic log in user, because then all multi-user modes will
be available, including editing Admin password.
14 Settings menu
From the Settings menu, there are five settings submenus that can be accessed.
 General settings
 Communication settings to set up and enable
communication links
 Measurement settings
 Printer settings, and
 Date and time
Tap the submenu icon or text to proceed.
Pressing Back button will return to Main menu.
14.1 General settings

In General settings screen the following settings can be set up or modified:
 Sound Enabled or Disabled.

 Language of the user interface:
 Export format of data transmission can be set up, as

o Advanced text: Results are saved only
o Simple text: Results are saved with ranges
o Extended text: Results are saved with histograms and
ranges
 Screensaver time setting:
o specifies the time elapses without touch screen activity
before the screen goes off to conserve power. Default setting:
15 min.
 Barcode reader can be Enabled or Disabled.
After changes made, press Accept to save changes and exit. Press Cancel to discard changes, and
return to Settings menu.
14.2 Communication settings

Communication settings menu is used to set up communication
ports.
Tap Communication in Settings menu to enter
Communication settings menu.
There are two submenus available:
 Device communication – this menu allows the operator
to set up network address or enable DHCP and other network
settings.
 Peer communication – this menu helps enabling and

disabling different communication ports.
See details in the sections below.
14.2.1 Device communication

Tap Device communication in Communication settings menu
to enter this menu. The following settings can be modified:
DHCP : Disabled or Enabled. If DHCP is enabled, the master
device on the local network will assign device address for
Abacus 3CT.
IP address: If DHCP is disabled, enter a valid IP address in order
to use Abacus 3CT in the network. Contact the network
administrator for details on IP address in your laboratory
network.
Gateway: typically set to 0.0.0.0
DNS: typically set to 0.0.0.0
Current settings are shown for reference below in shaded area.
Press Accept to save settings and return to previous menu.
Press Cancel to exit without saving changes.
14.2.1 Peer communication

Tap Peer communication in Communication settings menu to enter this menu. The following
settings can be modified:
PC: PC communication can be Active or Inactive.
PC remote IP address: A valid network address should be set up
here if PC setting is Active, otherwise the analyzer cannot
transmit data to the LIS.
EMR: EMR (remote work list mode) can be Active or Inactive.
EMR remote IP address/EMR local port: A valid network
address should be set up here if EMR setting is Active,
otherwise the analyzer cannot transmit/receive work list
to/from LIS.
USB-Serial link: Can be Enabled or Disabled. If a PC is connected
via the USB-B port, this setting should be Enabled.
USB-Serial Baud Rate: To connect PC via USB B emulated serial
link, set up baud rate here identically to the setting of the
connected PC serial link baud rate.
Automatic send: This setting can be one or combination of
links enabled. After a measurement is completed, data record
will be sent automatically to the ports selected here.
Press Accept to save settings and exit or Cancel to exit without saving changes.
By tapping automatic send button, the active/enabled ports can
be configured for automatic data transmission after every
measurement.
Select one of the options on the screen for automatic sending of
data records after measurement:
 Disabled: no records will be transmitted automatically
 PC only: records will be sent to PC connected via LAN port
 EMR (LIS) only: records will be sent to LIS address via
LAN
 PC and EMR(LIS): records will be sent to both addresses
via LAN (Ethernet) port
 USB-Serial: records will be sent on USB B port to PC
Contact service personnel or LIS administrator for more
information on network settings.
14.3 Measurement settings

In this menu measurement related settings can be modified.
Press Measurement in Settings menu to enter this menu.
There are two options:
 going to Units submenu, or
 selecting Normal ranges menu.
Press Home to return to Main menu.
Press Back to return to Settings menu.
14.3.1 Measurement units settings

This setting menu can be used to set up units of measured parameters.
Tap the white fields to change and Accept to save changes made.
14.3.2 Normal ranges settings

In this menu Normal ranges can be set up for Human, Male, Female and all other Profiles.
Tap the Type field to select profile to edit or review.
Profile 1..7 can be renamed by pressing Rename button.
Press ⇦ and ⇨ keys to move between normal ranges screens
of parameters.
Push any of the parameters field to edit the value, and press
Enter.
Press Accept to save changes made, or Cancel to discard
changes.
14.4 Date and time settings
In this menu format and actual value of system date and time
can be set up.
To enter this menu select Date and time in Settings menu
Tap the white field to modify settings:
Date: enter current date in the format selected below under
Date format.
Time: enter current time, and press Enter.
Date format: select date format one of Day/Month/Year or
Month/Day/Year or Year/Month/Day formats.
Time format: can be 12h mode or 24h mode.
Press Accept to save date and time settings and exit or Cancel
to exit without saving changes.
14.5 Printer settings

Enter this menu to select printer used for printing and other settings related to printing.
There are the following options available:
 Tap Device to select printer and related settings, or
 Push Format to adjust individual fields printed
 Home button takes you to Main menu
 Back button will step back to Settings menu
In Printer settings menu tap the
white field to modify settings:
Printer: USB or Built-in
Mode: printing mode can be
Black&White or Color.
Paper: sets up paper size for
printing: A4 or Letter
Top margin: displacement from
edge of paper, expressed in
Margin unit setting option (cm or
inch).
Automatic printing: if Enabled, the analyzer will print all
measurement results automatically after each measurement.
In printer format menu, tap the

white field to Enable/Disable:
Limits: if Enabled, normal ranges will be printed on the report
Warnings: if Enabled Warning flags will appear on printout
Technical information: controls printing of lyse volume and
probe voltages
Diagnostic flags: if Enabled diagnostic flags will be printed
Logo: if enabled, Abacus 3CT logo will be printed in header
Operator can set up text printed into the Laboratory headers.
Header lines 1..4: can contain customized text, name of lab,
address, telephone number, contact person, etc.
Tap the appropriate white field to enter or modify text.
Press Accept to save settings and exit, or press Cancel to exit
without saving changes.
15 Routine Maintenance
15.1 User-accessible parts
There is a side door on the right side of the analyzer. It allows the operator reach the fluidic system
and the mechanical parts for maintenance.
X-Y sampling Sampler Reagent

unit with Head sensors
piercing Blood Sensor
needle
Big glass
vacuum
Measuring chamber
chambers
Dilutors
RBC aperture
assembly Sampling
micro dilutor
WBC aperture
assembly HGB head Valves Dilutors
The operator is allowed to access, maintain and check the following parts behind the
side door of Abacus 3CT:
 Tubing and chambers
 Wash head on the XY needle moving mechanics
The following parts must NOT be opened or serviced by the user:
 power supply
 instrument housing, and electronic boards
15.2 Maintenance schedule

The operator should carry out below user maintenance/check-up activities to the analyzer.
15.2.1 Daily maintenance, before daily routine

 Check reagent condition: go to reagent status screen, check if the liquid amount in reagent
containers is enough for the expected number of daily measurements.
 Check the contents of waste tank: if the level is above 80% empty the waste container.
 Check the existence of air bubbles at rear reagent liquid connectors and syringes (except
waste line). In case of bubbles experienced, reagent prime and perform a blank
measurement.
 Run Blank measurement daily: if the results of the blank measurement are within range,
accept the results and proceed with your routine.
 Run QC samples according to established laboratory protocols before patient samples.
15.2.2 Daily maintenance, after daily routine

 At the end of the day, before shutting the analyzer down, go to Main Menu/Maintenance
/Cleaning to run the required daily cleaning.
15.2.3 Weekly maintenance

 Perform Hard Cleaning: Put 1ml of HypoClean CC solution into a sampling tube and run Hard
cleaning function in Main Menu/Maintenance/Cleaning menu.
 Check tubing system: open the side door and look for any liquid leakage. If you experience
leakage, contact authorized technician.
 Clean the needle wash head:
 Perform shut down procedure and turn the analyzer off
 Open the side door
 Use a moistened cotton swab to remove salt and blood residuals from the bottom of
the wash head
The sharp tip of the piercing needle can cause injury. Always use rubber gloves
and a cotton swab to clean the wash head to avoid injury to fingers.
15.2.4 Semi-annual Maintenance

Certified service personnel should carry out periodic service maintenance to Abacus 3CT.
15.3 Cleaning the Analyzer
Disconnect Abacus 3CT power supply from the electric network before cleaning the
chassis of the analyzer and front cover.
 Clean the instrument and its power supply on the outside only, using a damp cloth with
some soft detergent.
 DO NOT let liquids get inside the unit or to electrical connectors.
16 Troubleshooting
Abacus 3CT provides all the necessary software maintenance functions required to keep the
analyzer operating in optimum working order. Despite excellent maintenance, the analyzer can still
encounter problems where operator intervention is required. Abacus 3CT analyzer software
informs the operator of situations when further help is required. These are called error messages.
16.1 Error messages

Abacus 3CT analyzer provides additional information in the
form of numerical codes that help the operator to identify
the root cause of the error. These error codes are important
for service personnel. They can interpret the messages and
take necessary actions.
If you receive error messages with codes, please write them
down. If possible, describe what you were doing before the
error appeared. This important information helps your
service engineer to help you when necessary. The software
will store and re-display every error message, but it cannot
describe the operation you were performing when the error
happened.
When an error comes up, the software usually attempt to
offer a solution, or will try to resolve the problem and retry
the current operation. If this recovery process fails, or the
problem continues to occur, please contact your service
engineer.
16.2 Pneumatic/mechanical error messages

The analyzer software is designed to be error
tolerant and recover from minor problems.
However, if some physical obstructions or extreme
operating conditions cause some mechanical parts to
behave unexpectedly, the system will give you an
error message such as this.
Clicking Retry retries the current operation.

16.3 Mechanical Problems

Most mechanical problems arise because of some physical blockage of the moving parts. Problems
caused by severe blocks are usually accompanied by a grinding noise. The noise is a result of a
motor not being able to move, but this does not usually result in mechanical damage to moving
parts.
16.3.1 Sample Rotor Failures

 The sample vial is too tall causing the vial hit the front cover or incorrect sample adapter is
used. Replace and Retry operation.
 The opening on the front is not aligned with the sample rotor door.
 Open the door and check the wash head for contamination (blood and/or salt) as excessive
salt build up can prevent the wash head from lifting up effectively and the sample rotor door
can get stuck. Perform wash head cleaning (see section 15.2.3).
16.3.2 Needle Mechanics, Vertical Motor (MVert) Problems

 Sampling depth is not set up correctly for the tube used. Refer to section 8.1.2.
 Salt build up, or thick salt layer at the bottom or on the inside can block the movement of the
needle in the wash head (or the movement of the wash head around the needle).
 The piercing needle is bent or the needle is not set/misaligned. Call service personnel.
 The vertical rod holding the needle carriage is blocked by something. Try removing the part
that causes the block or call service personnel.
16.3.3 Needle Mechanics, Horizontal Motor (MHori) Problems

 The piercing needle is bent or the needle is not set or moved vertically. Call service
personnel.
 The horizontal driving rod holding the needle carriage is blocked by something. Try
removing the part that causes the block or call service personnel.
16.3.4 Dilutor Errors

 Pinched, clogged tube around dilutor or at the rear reagent tubes – check for free flow of
reagents.
 Physical obstruction (foreign material) got into the tubing.
16.3.5 Priming Problems – reagent warnings

 The respective reagent is out, replace reagent.
 Aspirating tube (in container):
o has fallen off,
o kinked – remove the blockage,
o has a leak or broken – cut a piece off from the end, and reconnect reagent
lines/tubes
 Reagent tube is popped off. Open side door and look for the open tube, then reconnect it to
the valve or tubing connection.
 Damaged tube in the system, look for leakage, or traces of liquid, and contact Service
16.3.6 Touch screen is not working

 Check if the screen is vet, make sure to wipe it dry
 Turn the analyzer off and on again to retry operation
 Connect an external USB mouse:
o This will allow clicking on the screen elements
o Contact service for resolution of the problem
16.3.7 The Analyzer Does Not Power On

 Check proper power connections, and the state of the (small) switch at the power supply
 If the above fails, contact Service
16.4 Problems related to Measurement results

16.4.1 Measurement with Warning Flags
Please, refer to section 9.2 for details and remedy actions in connection with warning flags.
16.4.2 Fluctuating PLT background

 When Abacus 3CT is used in increased workload, running 200-300 samples a day, 5 hours of
continuous operation is possible. Despite built-in maintenance programs, the system may
require intensive cleaning from time to time. If you find that blank PLT values are not
consistent, or increasing unexpectedly, please perform a ‘Hard cleaning’ function using
D8011 HypoClener CC reagent as described in section 11.1 and then measure Blank several
times to make sure the analyzer is clean and stable.
 If stable high PLT blank is encountered, check if the reagents are contaminated or not. You
may open a new tank of diluent to see if PLT blank becomes low and acceptable.
 When replacing reagent, always make sure to avoid contamination to the drop down tubes.
Flush them with tap water and clean (wipe) the outer surface of the tubes with a clean and
damp cloth before putting them into the new reagent, otherwise cross contamination may
happen.
 Do not forget, that proper grounding is essential for stable, background free operation.
 If PLT blank fluctuates, check if there is a device nearby that radiates electromagnetic noise.
Relocate the analyzer if you suspect that electronic interference is causing high PLT blank.
17 Performance Characteristics
Performance characteristics of Abacus 3CT are described in below sections:
 Accuracy
 Precision
 Linearity
 Carry-over
 Sample Stability
 Reference ranges
 Interfering Substances
17.1 Accuracy
Difference Criteria Evaluation Levels
Parameter
Absolute Percent Range Low Range High
WBC (103/µl) 0.30 6.00% 0.00 85.00
GRA% (%) 3.00 10.00% 0.00 100.00
LYM% (%) 3.00 10.00% 0.00 100.00
MID% (%) 3.00 10.00% 0.00 40.00
RBC (106/µl) 0.15 6.00% 0.00 8.00
HGB (g/dl) 0.30 6.00% 1.00 25.00
MCV (fl) 1.00 6.00% 50.00 120.00

RDW (%) 0.50 6.00% 8.00 20.00
PLT (103/µl) 15.00 8.00% 0.00 1000.00
MPV (fl) 0.50 10.00% 5.00 30.00
17.2 Precision
Repeatability Within-Device Precision
Parameter
SD CV% SD CV%
WBC (103/µl) < 0.18 < 2.7 % < 0.40 < 4.0%
GRA% (%) < 3.5 < 8.0% < 3.5 < 8.0%
LYM% (%) < 3.1 < 8.0% < 3.1 < 8.0%
MID% (%) < 2.0 < 17.0% < 2.0 < 17.0%
RBC (106/µl) < 0.11 < 1.7 % < 0.15 < 2.5 %
HGB (g/dl) < 0.20 < 2.0 % < 0.22 < 2.4 %
Repeatability Within-Device Precision

Parameter
SD CV% SD CV%
MCV (fl) < 1.0 < 1.7 % < 1.20 < 2.0 %
RDW (%) < 0.4 < 2.5 % < 0.45 < 3.0 %
PLT (103/µl) < 23 < 6.0 % < 27 < 7.0 %
MPV (fl) < 0.45 < 8.7 % < 0.5 < 10.0 %
17.3 Linearity
Nonlinearity
Determination Nonlinearity Reportable Reportable
Parameter absolute
(R2) relative error Low High
error
WBC (103/µl) > 0.95 < 0.80 < 3.0 % 0.0 85.0
HGB (g/dl) > 0.95 < 0.27 < 3.0 % 1.0 25.0
RBC (106/µl) > 0.95 < 0.20 < 3.0 % 0.00 8.00
PLT (103/µl) > 0.95 < 35 < 3.0 % 0 1000
17.4 Carry-over
Maximum Reportable
Parameter Reportable Low
Carryover (%) High
WBC (103/µl) < 1.0% 0.2 83.0
HGB (g/dl) < 0.8% 1.0 23.0

RBC (106/µl) < 0.5% 0.40 7.70
PLT (103/µl) < 1.0% 11 975
17.5 Sample Stability
Long-term sample stability studies on blood specimens drawn in K2- and K3EDTA collection tubes at
room temperature showed no significant clinical variation for all parameters between 30 minutes
and 7 hours post phlebotomy. MPV results can show instability in the first two hours but are stable
afterwards.
17.6 Reference ranges

Parameter Male Female Human Units
Low High Low High Low High
WBC 4.0 11.7 4.0 11.7 4.0 11.7 103cells/µl

LYM% 7.1 43.1 7.1 43.1 7.1 43.1 %
MID% 0.0 18.8 0.0 18.8 0.0 18.8 %

GRA% 44.4 86.4 44.4 86.4 44.4 86.4 %
LYM 0.6 3.1 .06 3.1 0.6 3.1 103cells/µl
MID 0.2 1.8 0.2 1.8 0.2 1.8 103cells/µl
GRA 2.4 9.2 2.4 9.2 2.4 9.2 103cells/µl
RBC 3.26 5.73 2.75 5.59 2.75 5.73 106cells/µl
HGB 10.1 16.5 8.8 15.5 8.8 16.5 g/dl
HCT 30.6 49.6 26.1 47.4 26.1 49.6 %
MCV 76.4 102.0 76.4 102.0 76.4 102.0 fl

MCH 23.3 36.1 23.3 36.1 23.3 36.1 pg
MCHC 29.7 36.7 29.7 36.7 29.7 36.7 g/dl
RDW 12.2 16.6 12.2 16.6 12.2 16.6 %
PLT 97 390 97 390 97 390 103cells/µl
MPV 7.1 10.9 7.1 10.9 7.1 10.9 fl
17.7 Interfering Substances

The following substances can interfere with parameter measurement and alternate measurement
procedures may be required.
Parameter Interference
WBC > 5 NRBC’s/100 WBC’s , PLT clumps/large PLTs
RBC WBC Count > 50.0 x103/µl

MCV WBC Count > 50.0 x103/µl
PLT PLT clumps/large PLTs (Abnormal histogram)
HGB WBC count > 50.0 x103/µl , Lipids > 270 mg/dl
Differential > 5 NRBC’s/100 WBC’s , PLT clumps/large PLTs (Abnormal histogram)

18 Print Formats
18.1 Print Formats of built-in printer
18.2 Table print format
18.3 Print formats of external printer

Levy-Jennings chart: Patient report:
19 Specifications
Item Description
Operating conditions Temperature: 15–30 °C. Optimal temperature is 20-25 °C.
Relative humidity: 45-85% non-condensing
Storage conditions Temperature: 5–35 °C.
Relative humidity: 15-90% non-condensing
Power supply unit External, auto-ranging power supply unit.
Input: 90-240 VAC, 47–63Hz
Maximum input current: 6A at 90VAC, 3A at 240VAC.
Output: 12VDC, max. 8.3A, max. 100W
User interface Easy-to-use, menu driven user interface with a touch screen
Languages available English, Bulgarian, French, Greek, Indonesian, Italian, Polish,
Portuguese, Russian, Rumanian, Slovenian, Spanish, Turkish
Data storage capacity 10,000 results with RBC, PLT, and 3-part diff. WBC histograms
Host computer USB-B port (direct connection to host computer via USB port)
interface PC, LAN: Ethernet port on the back
Data back-up method USB mass storage device up to 16 Gbyte size
Send data to LIS (Laboratory Information System)
Printer interface USB with support for most HP printer languages (DeskJet, LaserJet,
PCL3, PS, LIDIL)
Built-in printer optional 58 mm thermal printer, monochrome printout with
histograms
Display 8” (173x104 mm), LED backlit, color graphics LCD
External keyboard USB connection
Software upgrade via USB-A port using USB mass storage device (max. 16 Gbytes of flash
method drive)
Sampling volume 100 μl of whole blood
Chambers 3 chambers for diluting whole blood and counting; MIX, RBC, WBC
+1 needle-washing/draining chamber
Reagent system Isotonic Diluent, Lyse, Cleaner (see section 5.3)
Aperture diameter 80 μm (RBC/PLT), 100 μm (WBC)
Throughput 60 tests/hour
Sampling method Open or closed tube system with automatic sample rotor
Specimen types Human whole blood, Control blood
supported
Recommended sample K2- or K3-EDTA primary blood sample tubes
collection method
Sample identification Individual sample ID entered by user. Barcode with external manual
method barcode reader (optional accessory)
Sample types Control, Human, Male, Female, (built-in reference ranges), with Profiles
1 – 7 for additional user-defined ranges.
Clog prevention High-voltage pulse on apertures in each analysis cycle; chemical

cleaning; high-pressure back flush of apertures.
Cleaning procedure High-voltage burst of the apertures, high-pressure back-flush, chemical
cleaning of the apertures.
Quality control max. 24 QC levels, QC parameters including:
number of runs, mean, ± range, SD and CV for all measured and
calculated parameters, Levy-Jennings charts, and separate QC database.
Calibration Automatic with 3 or 7 measurements, or manual (factorial) calibration
of WBC, HGB, RBC, RDWc, PLT, MCV and MPV.
Dimensions (WxDxH) 316 x 492 x 360 mm
Net weight 17,8 kg
19.1 Reagent consumption chart of Abacus 3CT

Below chart summarizes the reagent consumption of individual fluidic functions.
Reagent consumption / function (ml)

Diluent Lyse Cleaner
Function D1512 D2011HK D5011
Startup (init + wake up) 114.0 3.0 6.5
Shut down 54.0 0.0 4.6
Measure Blank 40.2 1.1 0.0
Measure Human 41.0 1.1 0.0
Measure Calibration 40.9 1.1 0.0
Measure QC 40.9 1.1 0.0
Prime Diluent 36.0 0.0 0.0
Prime Lyse 14.8 2.4 0.0
Prime Cleaner 19.3 0.0 2.0
Prime All 29.2 2.1 1.9
Standby 13.5 0.0 0.0
Wake up 0.9 0.0 0.0
Clean 49.8 0.0 4.6
Hard clean 76.5 0.0 0.0
Self-test 11.4 0.0 0.0
Preparing for shipment: 122 ml of D4011 (Rinse) or DI water
Hard cleaning cycle: 0.4 ml of D8011 HypoClean CC
Table 6. Reagent consumption charts

20 Fluidic Schematics
21 Calibration of Bar Code Reader (Motorola DS4208 only)

Use this sheet to calibrate the Motorola DS 4208 bar code reader for use with Abacus 3CT analyzer.
To calibration DS4208 follow the steps below:
 Connect the bar code reader to one of the USB slots on the back or the side of the instrument
 Turn on the analyzer
 Read the bar codes below, one after another from the top to the bottom.
 DS4208 bar code reader is ready to use with Abacus 3CT.
1.
2.
3.
4.
end of document

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Abacus 3CT

1.03 Árpád Gyetvai Minor changes, dimensions, weight 2014-03-21

1.1 Árpád Gyetvai Minor edits 2014-07-15

1.2 Márton Rajkai New software release update 2014-08-04

Ref Team Role Name Signature Date

1 R&D Director Gábor Farkas 2014-07-15

2 QA Mike Switzer 2014-07-15

1097 Táblás utca 39.

5 General Overview and Principles of Operation ....................................... 21

5.6.3 3-Part Differential Analysis Method.................................................................................................. 26

6 User Interface ...................................................................................................... 31

7 Start-up and shut down of Abacus 3CT....................................................... 35

8.1.2 Sampling Depth .......................................................................................................................................... 38

9 Interpretation of Results ................................................................................. 47

10.4 Managing selected records in database ................................................................................ 56

11 Maintenance menu ............................................................................................ 62

12 Quality Control (QC) Menu.............................................................................. 72

13 Multi-User Mode ................................................................................................. 74

13.2 Logging in ......................................................................................................................................... 74

14 Settings menu ...................................................................................................... 77

16.3.6 Touch screen is not working ........................................................................................................... 89

17 Performance Characteristics ......................................................................... 90

1 Indications for Use

If equipment operation is different from the manufacturer’s specifications and

2 For Your Safety

2.2 Special Symbols Used In This Manual and on the Analyzer

Label Meaning Explanation

Blood samples and analyzer waste are potentially infectious

Corrosive Reagents may cause corrosion or skin irritation.

Warning General warning of possible hazard conditions.

2.3 General Precautions

The analyzer should be moved holding the analyzer in an upright position.

To ensure reliable operation and reliable results:

Electromagnetic environment should be evaluated prior to operation of the device.

This analyzer contains electronic components. Please handle electronic waste

2.4 Environmental Requirements

2.5 Electrical Requirements

2.6 Space Requirements

Figure 1. Abacus 3CT Space Requirements

For recommended placement of the reagents, see section 4.3.2

2.7 Weight Requirements

2.8 Waste Disposal

System waste should be handled as a potentially bio-hazardous material. All applicable

2.9 Known Limitations

2.10 Emergency Situations

4.1 Abacus 3CT Analyzer Package

 3 sample tube adapters for the sample rotor

Please, inform your sales representative if any item is missing or damaged.

4.3 Installation check-list

4.3.1 Select a suitable location

4.3.2 Connect reagents

Figure 2. Recommended placement of Reagents and Waste

Figure 3. Establishing correct waste connection

4.3.3 Connect power

4.3.4 Connectible peripheral devices

5 General Overview and Principles of Operation

5.2 Measured Parameters

Parameter Description Unit Calculation method

WBC White Blood Cell count cells/l, cells/µl Number of leukocytes