Operator’s Manual

Automated 3-part Hematology Analyzer

Norma Instruments Zrt.

Arany János u. 11-13, 3530 Miskolc, Hungary
Papírgyár u. 58-59, 1038 Budapest, Hungary

Icon-3 product code: NI30H

Icon-3 software version: 1.3.1652.0
Manual Issue date: 2020/11/27
Manual Revision: v34
Contents
Foreword................................................................................................... 9
Introduction ............................................................................................ 10
Who should read this manual? ........................................................... 10
Symbols used in the manual ............................................................... 10
Intended Use....................................................................................... 10
Disclaimer ........................................................................................... 11
Symbols on the outside of the analyzer ............................................. 12
Technical contact ................................................................................ 13
Warranty ............................................................................................. 13
Exclusions to warranty ........................................................................ 14
Measurement technology ...................................................................... 15
Impedance based cell counting .......................................................... 15
Hemoglobin measurement method ................................................... 15
Interpreting histograms ...................................................................... 16
Hematology parameters ..................................................................... 17
3-part differentiation of White Blood Cells ........................................ 18
The measurement process ................................................................. 18
Supported blood collection tubes ...................................................... 20
Package contents .................................................................................... 21
Accessories.......................................................................................... 22
Identifying parts of the analyzer ......................................................... 23
Installing the analyzer ............................................................................. 25
User serviceable parts ........................................................................ 26
Connecting peripheral devices ........................................................... 26
Keyboard (optional) .......................................................................... 26
Mouse (optional)............................................................................... 26

Page 2 OMICON3_v34
 Bar code scanner (optional) .............................................................. 26
USB flash drive (optional) ................................................................. 26
USB Wi-Fi Dongle (optional) ............................................................. 27
Network (“Ethernet”)........................................................................ 27
Reagent pack ..................................................................................... 27
Reagent bottles ................................................................................. 28
Analyzer packaging material ............................................................... 28
Power ...................................................................................................... 29
External power supply ........................................................................ 29
Power button ...................................................................................... 29
Power on ............................................................................................. 30
Power off ............................................................................................ 30
Emergency power off.......................................................................... 31
Handling reagents ................................................................................... 31
Precautions about reagents ................................................................ 31
Reagent characteristics....................................................................... 31
Blood samples ......................................................................................... 32
Taking the sample ............................................................................... 32
Transporting and storing samples ...................................................... 33
Sample age .......................................................................................... 33
Preparation for analysis ...................................................................... 33
Proper Sample Mixing prior to run ..................................................... 34
Bubbles in sample ............................................................................... 35
Sample handling ................................................................................. 35
Menu system .......................................................................................... 36
The screen area................................................................................... 36
Menu tree ........................................................................................... 37

Page 3 OMICON3_v34
 Gestures .............................................................................................. 37
Tap..................................................................................................... 38
Swipe ................................................................................................. 38
Hold ................................................................................................... 39
On-screen keyboard............................................................................ 39
Data input ........................................................................................... 40
Alphanumeric input .......................................................................... 40
External keyboard ............................................................................. 40
Barcode input .................................................................................... 41
Numeric input ................................................................................... 41
Description of icons displayed ............................................................ 42
Setup ....................................................................................................... 45
Initial setup ......................................................................................... 45
Language ........................................................................................... 45
Time and date ................................................................................... 46
Laboratory specific information (printout contents) ........................ 46
Report output (email) ....................................................................... 46
Settings – Customize........................................................................... 47
Appearance ....................................................................................... 47
Languages.......................................................................................... 48
Units .................................................................................................. 48
System Settings ................................................................................... 49
Date and time ................................................................................... 49
Email settings .................................................................................... 49
Network preferences ........................................................................ 50
Printout Settings ............................................................................... 51
Printout Format................................................................................. 52

Page 4 OMICON3_v34
 Network Printing ............................................................................... 54
Customization ................................................................................... 55
Profiles .............................................................................................. 56
LIS (Laboratory Information System) ................................................ 57
Measurement Settings ...................................................................... 58
Setting up reagents ............................................................................. 59
Reagent: Pack .................................................................................... 59
Reagent: Individual Reagents............................................................ 61
Manual QR code entry ...................................................................... 63
Network Settings ................................................................................ 64
Wi-Fi settings .................................................................................... 65
Wired network settings..................................................................... 65
Daily operation ....................................................................................... 66
Power on ............................................................................................. 66
Running samples ................................................................................. 67
Closed tube mode ............................................................................. 67
Open tube mode ............................................................................... 69
Results................................................................................................. 71
Short (Quick) result ........................................................................... 71
Full result (Full screen) ...................................................................... 72
Flags .................................................................................................. 73
Interpretative Flags ........................................................................... 77
Reports................................................................................................ 78
PDF .................................................................................................... 78
Printer Thermal ................................................................................. 79
Printer PCL5/6 ................................................................................... 80
Power off ............................................................................................ 81

Page 5 OMICON3_v34
 ER mode .............................................................................................. 83
ER Sampling....................................................................................... 83
ER Results .......................................................................................... 84
Switching between ER and Admin mode .......................................... 85
Calibration............................................................................................... 86
Target values....................................................................................... 86
Mode-to-mode calibration ................................................................. 87
Automatic calibration ......................................................................... 88
Manual calibration .............................................................................. 90
QC – Quality Control ............................................................................... 91
Expected values .................................................................................. 91
Assay sheets ...................................................................................... 92
QC diagrams ...................................................................................... 94
QC reports ......................................................................................... 95
Database functions ................................................................................. 96
Browsing records ................................................................................ 96
Database context menu...................................................................... 97
Selecting records................................................................................. 98
Moving to specific date in database ................................................... 98
Selecting records between two dates ................................................ 99
Search (filtered view) .......................................................................... 99
Managing data .................................................................................. 100
Managing data in Recycle Bin ........................................................... 100
Sending e-mail .................................................................................. 100
LIS transmission error ....................................................................... 101
Maintenance ......................................................................................... 102
Cleaning the analyzer........................................................................ 102

Page 6 OMICON3_v34
 Daily maintenance ............................................................................ 102
Weekly maintenance ........................................................................ 102
Emergency procedures ..................................................................... 102
Reagent pack replacement ............................................................... 103
Replacing reagent bottles ................................................................. 103
Cleaning procedures of the fluidic system ....................................... 104
Software update ............................................................................... 104
Management menu .......................................................................... 105
Maintenance ................................................................................... 105
Alarm Clock symbol ......................................................................... 108
Diagnostics ...................................................................................... 109
Service ............................................................................................. 110
Supervision ........................................................................................... 111
History............................................................................................... 111
History details ................................................................................. 111
About menu ...................................................................................... 112
Database capacity ........................................................................... 113
Status bar .......................................................................................... 114
Technical Specifications ........................................................................ 115
Performance Data ................................................................................. 117
Precision............................................................................................ 117
Accuracy ............................................................................................ 117
Linearity ............................................................................................ 117
Display range of parameters............................................................. 118
Carry-over ......................................................................................... 119
List of measured parameters ............................................................ 119
Known Limitations, interfering substances .......................................... 120

Page 7 OMICON3_v34
 Low PLT performance ....................................................................... 120
PLT clumps ........................................................................................ 120
HGB interference .............................................................................. 120
Anti-coagulant used .......................................................................... 121
Sample age ........................................................................................ 121
Nucleated RBC (nRBC) ...................................................................... 121
Electrical block diagram ........................................................................ 122
Fluidic diagram...................................................................................... 123
Reagent consumption ........................................................................... 124
Error messages...................................................................................... 125
Mechanical Errors ............................................................................. 125
Operation related errors................................................................... 126
Electronic errors ............................................................................... 128
System (software) errors .................................................................. 128
Troubleshooting.................................................................................... 132
Measurement problems ................................................................... 132
Electrical problems ........................................................................... 133
Mechanical problems ....................................................................... 134
Hydraulic problems ........................................................................... 135
Network problems ............................................................................ 136
Printer problems ............................................................................... 136
Directives and Standards ...................................................................... 137
Declaration of Conformity .................................................................... 138
Errata .................................................................................................... 138
Revision history..................................................................................... 139

Page 8 OMICON3_v34
Foreword

Thank you for choosing the Norma Icon-3 automated hematology

analyzer.

We believe that Icon-3 is the suitable blood cell counter to your needs
and will ease your daily laboratory routine.
Welcome to the Norma family…

Page 9 OMICON3_v34
Introduction
Icon-3 is a small, 60 tests/hour impedance-based hematology analyzer for small
to medium size laboratory use, performing 3-population analysis of human
whole blood samples. Icon-3 is easy to use and uses low amounts of reagent to
determine 22 hematology parameters.
Icon-3’s small footprint allows operating in space-constrained environments.

Who should read this manual?

This manual is written for operators of the analyzer describing the structure of
the analyzer, daily routine and basic maintenance required to keep the analyzer
in good working condition to ensure reliable and dependable operation.

Symbols used in the manual

This Operator’s Manual uses symbols listed below to indicate hazards in
connection with operating the analyzer. These symbols are used wherever such
hazards arise during operation or handling of the analyzer.
Symbol Meaning
WARNING
Risk of personal injury
BIOHAZARD
Risk of biological infection, contamination

Intended Use
Icon-3 is a 60 tests/hour impedance based IVD hematology analyzer for
laboratory use, using specific reagents, performing 3-population, 22 parameters
analysis of anti-coagulated human whole blood samples introduced in open or
closed vials.
Icon-3 is suitable for use as a Pont-of-Care analyzer provided that the analysis
results are approved and validated by a trained healthcare professional.

Page 10 OMICON3_v34
Disclaimer
The manufacturer reserves the right to:
- modify the contents of this manual without prior notice,
- change technology applied within the analyzer without prior notice,
- change technical specifications without prior notice.
The manufacturer does not warrant this manual to be 100% free of unintentional
errors.
Please note that this Manual may be revised without prior notification. The
Manufacturer reserves the right to change the specifications of the product
and/or the contents of this manual as deemed necessary, without prior notice.
Pictures included in this manual may differ from the actual delivered product.
Performance and reliability are never influenced by minor visual differences
between this manual and the actual product.

Page 11 OMICON3_v34
Symbols on the outside of the analyzer
Symbol Meaning
WARNING
Risk of personal injury
BIOHAZARD
Risk of biological infection, contamination

CE mark

for In Vitro Diagnostic use

Address of manufacturer

Date of manufacture

Serial number

Catalog number

See instruction for use (manual)

Waste of electrical and electronic equipment

Page 12 OMICON3_v34
Technical contact
Icon-3 is a precision laboratory instrument. Its built-in safety measures guarantee
safe and reliable operation. Any malfunction is indicated by the software, and
suggestions are made to remedy the situation. Being a complex device, there is
limited access to internal structures provided to the end user.
Under no circumstances should the Operator attempt to open or remove the
outer cover of the analyzer, as this may influence reliable operation and might
fool built-in safety measures and can invalidate warranty.
There are no user serviceable parts inside this analyzer. Adjustments of internal
structures and repairs of these structures should only be performed by qualified
service personnel.
Your local dealer is always ready to help you in case of malfunction.
The contact of your local dealer is available on the insert of this Manual.
Please use the [email protected] email address to contact the
manufacturer directly.
Norma will be doing its best to resolve your problems either directly or indirectly
with the help of its local representative.

Warranty
Your Icon-3 comes with a manufacturer’s warranty against workmanship defects.
Warranty claims must be made through your local representative.
Your supplier will only be able to repair and warrant operation of the analyzer as
per its specifications if all service actions are performed by qualified Service
Personnel, and the Warranty Label is intact.
Warranty is void if any of the below can be identified, or inoperability,
malfunction can be traced back to any of the events listed below:
- broken warranty seal;
- intentional damage and/or modification to the analyzer;
- improper use, use against instructions in this manual, against intended
use;
- damage from intentional activities overriding built-in safety logic;
- natural disaster;

Page 13 OMICON3_v34
 - uncertified power supply, or unapproved peripheral has been
connected to the analyzer;
- disassembly, repair attempt performed by unauthorized staff;
- damage rooted back to unreported shipping and/or installation induced
activities.
The manufacturer does not recommend and support modifying the operating
software of this hematology analyzer. The analyzer is able to log and track
modifications to the operating software.
- In the case, when the End User required or performed installation of
any software product not controlled by the manufacturer and would
afterwards experience erroneous or unreliable operation of the
analyzer, or would experience erroneous results, then the manufacturer
cannot accept any complaints about operation, reliability or
performance.

Exclusions to warranty
The below listed items are not covered by warranty unless they were found
damaged upon arrival to the End User. In such cases, proper complaint must be
filed along with a complaint registered with the forwarder/Distributor company:
- Batteries, external power cable
- Plastic cover elements (including transparent display cover),
- External reagent tubes, rear reagent connector, external reagent
connector
- Labels, printed material
- Internal piercing needle, flexible sampling tip, power button, open wash
head.

Page 14 OMICON3_v34
Measurement technology
Icon-3 uses volumetric impedance and photometric method for measurement to
provide 22 hematology parameters from 13 µl (open sampling mode) and 38 µl
(closed sampling mode) of whole human blood samples.
The measurement cycle time is:
• 60 seconds in closed mode yielding 60 tests/hour throughput, and
• 90 seconds in open sampling mode (40 tests/hour).

Impedance based cell counting

Cells found in a blood sample have
various sizes. The volume of these
cells can be measured electronically.
A known direct electric current (I) is
driven through a small opening
(aperture – yellow on figure) with
70µm (for RBC/PLT detection) and
100µm (for WBC counting) of
diameter separating two liquid
compartments containing diluent,
that conducts electricity.
A syringe pump pushes through (blue arrow) the diluted blood sample from
one side of the aperture to the other side.
When there is only diluent in the aperture, a certain electric resistance can be
measured due to the conductive characteristic of the diluent.
Blood cells do not conduct direct current. When a cell (red circle above) passes
through the aperture (yellow) then the resistance of the liquid will increase for
the moment the cell passes the aperture. The change of resistance is
proportional to the volume of the cell in the aperture. The bigger the change, the
bigger the cell passing through the aperture.

Hemoglobin measurement method

Determination of HGB is based on absorption of light of the hemolyzed
WBC/HGB blood sample at 540 nm wavelength. A light source (green LED) and
detector are located at the bottom of the WBC syringe pump. HGB blank is
measured in each measurement cycle to maintain stable HGB results.

Page 15 OMICON3_v34
Interpreting histograms
Icon-3 presents histograms on its
screen, in printed or in electronic
format.

WBC histogram shows the

identified populations separated LYM MID GRA
by vertical lines (markers), giving
an indication of the borders of the populations.
- LYM contains lymphocytes (left of the left side marker)
- MID contains monocytes (between the two markers)
- GRA contains neutrophil, basophil and eosinophil cells (right to the
right-side marker)
Note: the above classification is valid for samples run within 12 hours from sampling

The algorithm is looking for populations in the histogram and marks the end of
MID population with vertical lines. The lines themselves do not mean that all cells
between the markers is the marked (MID) population, rather than the normal
distribution curve of the MID population resides between the volumes (fl)
indicated by these vertical lines.

RBC and PLT histograms are related in

such a way that the front of the RBC
histogram is magnified and repeated
as the PLT histogram.
The vertical line separating PLT and
RBC regions are present on both
histograms.

Page 16 OMICON3_v34
Hematology parameters
Parameter Explanation units
WBC White blood cell count 103/µL & 109/L
LYM# Lymphocyte count 103/µL & 109/L
MID# Mid cell count 103/µL & 109/L
GRA# Granulocyte count 103/µL & 109/L
LYM% Lymphocyte percentage (of WBC) %
MID% Mid cell percentage (of WBC) %
GRA% Granulocyte percentage (of WBC) %
RBC Red blood cell count 106/µL & 1012/L
HGB Hemoglobin g/dL, g/L, mmol/L
HCT Hematocrit %, L/L
MCV Mean Corpuscular Volume fL
MCH Mean Corpuscular HGB pg, fmol
MCHC Mean Corpuscular HGB Concentration g/dL, g/L, mmol/L
RDWsd/cv Red blood cell distribution width fL/%
PLT Platelet (thrombocyte) count 103/µL & 109/L
MPV Mean Platelet Volume fL
PCT Plateletcrit/thrombocrit %, L/L
PDWsd/cv Platelet distribution width fL/%
PLC-R% Platelet Large Cell Ratio; %
The ratio of PLT’s with volume above
12fl versus total PLT count
PLC-C Platelet Large Cell Count 103/µL & 109/L
of PLT’s with volume above 12fl

Page 17 OMICON3_v34
3-part differentiation of White Blood Cells
Three-part white blood cell differential counts (so-called diffs), performed during
electrical impedance counting of blood cells, can accurately classify lymphocytes,
granulocytes, and mononuclear cells in 85% of specimens, with an error rate not
exceeding that of conventional diffs. The differential count is made on diluted
specimens and additional hemolyzing agent that breaks down RBC and WBC cell
membranes.
Normal RBC’s have no nucleus; only WBC nuclei remain in the solution. The size
(volume) of various WBC nuclei will help the analyzer classify cells by the volume
of their nuclei.

The measurement process

The analyzer is able to process human blood samples in open or closed sample
vials. Closed tube mode is only available with certain vial types. The analyzer in
Closed mode will only run a vial that has the cap on. Vials without caps are not
processed.
Sample vials with caps are lowered into the sample disc that turns the vial upside
down to allow small sample volume aspiration. The vial is pushed onto a fixed
metal sampling needle and is pierced in the upside-down position. The fixed
needle is equipped with a washing head to clean the needle’s external and
internal surfaces.
Sample vials without caps can be run in open tube sampling mode. The open
sampling takes place via a retractable, flexible sampling tip equipped with a wash
head. The wash head cleans the outside of the sampling tip and aspirates excess
blood. The internal and external surfaces of the sampling tip are washed after
every open tube sampling process. During normal operation, the flexible
sampling tip is retracted into the analyzer.
The sampling system takes a total of 13 µl (open sampling mode) or 38 µl (closed
sampling mode) of blood, 2.5 µl of which is used for the measurement. After
closed sampling, the sample vial is returned and ejected in the top of the vial
holder.
A ceramic shear valve guarantees precise sampling volume. The 2.5 µl of blood
is mixed with isotonic diluent to create a dilution of approximately 1:200 dilution
rate (primary dilution). Less than 3 µl of this primary dilution is used to create
another dilution to the final dilution rate of 1:20000 (secondary dilution) using
the same isotonic diluent.

Page 18 OMICON3_v34
The rest of the primary dilution is mixed with cyanide-free hemolyzing reagent
and aspirated into the WBC syringe. The secondary dilution is aspirated into the
RBC syringe.
The syringes are using air bubbles to homogenously mix the respective dilutions
inside. Then a positive pressure (max 400mBar) is generated in both syringes and
measurements start. The positive pressure forces both dilutions through their
respective measuring heads composed of apertures of 70µm and 100µm for the
RBC/PLT and WBC counts, respectively.
The lysed WBC solution prior to entering the measuring aperture passes through
a microfluidic flow cell and is measured for HGB content at 540nm wavelength.
The cell counts are read simultaneously in the two channels along with a parallel
HGB measurement. The entire cell counting and HGB measuring process takes 8
seconds.
HGB blank is measured and evaluated during every sample. Icon-3 does not use
a separate HGB background measurement as a blank value. This allows a more
precise live tracking of performance.
As a final step, the system empties the measuring elements and is ready to take
the consecutive sample.

Page 19 OMICON3_v34
Supported blood collection tubes
Icon-3 can process human whole blood samples from open or closed sample
vials.
Icon-3’s closed tube mode supports the following closed sample vials:
Type, Manufacturer Minimum sample
volume
BD Vacutanier (∅13x75 mm) or compatible 400 µL

Greiner Vacuette (∅13x75 mm) or compatible 400 µL

BD MAP vials or compatible 250 µL

Please consult the Instructions for use of relevant primary sample tube types.
WARNING
Pierceable vial caps are designed for a limited number of
penetrations with a needle. Using a closed vial more than 5 times
without removing it from the sample rotor of Icon-3 poses a risk
of damaging the rubber cap and causing liquid damage or
clogging in the analyzer.

Icon-3’s open tube sampling supports any whole human blood collected in
sample vials prefilled with potassium-EDTA or prepared accordingly.
Icon-3’s retractable flexible sampling tip allows using a wide size range of sample
collection devices. The minimum blood sample volume to achieve reliable
sampling is 100µl.
Samples must be mixed/homogenized adhering to general blood sample
collection guidelines prior to analyzing them on Icon-3.
Refer to section Blood samples later in this manual.

Page 20 OMICON3_v34
Package contents
Icon-3 comes in a double cardboard packaging. The outer box provides a
protection against shipping damage to the analyzer’s internal box.

The internal box contains the analyzer and its accessories inside protective
foams. The analyzer comes with a protective film covering the scratch resistant
polycarbonate cover elements.
Upon arrival, carefully check the contents of the package and look for visible
damages, even on the outer packaging box. File any obvious damage through the
shipping company to be eligible for compensation and support from your local
dealer and from the manufacturer.
Packing list:
- Analyzer outer packaging box and shipping foams (top, bottom)
- Accessories box
o Power supply; Power cord
- Reagent tubing set
o Black cap cleaning vials
- Documents and Guides
o Calibration Certificate and Final Check Report
o Quick Guide
o Reagent Connector Guide
o Reagent Pickup Tubes Installation Advisory
o Installation Report
- Analyzer packaging bag
- Icon-3 analyzer

Page 21 OMICON3_v34
Accessories
• external power supply
SYS1443-6512-T3 or SYS1548-6512-T3

• grounded power cord matching your standard

power outlets

• reagent pickup tube set in a plastic bag:

o reagent connector
o tubing
o caps for various reagent setup
o draining tube kit
o black cap cleaning vials
o Reagent Connector Guide

Always use original accessories and cables.

Non-approved electronic accessories may damage the system
and can result in electric shock.

Page 22 OMICON3_v34
Identifying parts of the analyzer

Front and right side of Icon-3

1. Sample vial with cap
2. Status indicator ring
3. Front camera (in the middle of character O)
4. Opening for open tube sampling tip (retracted)
5. POWER/START button
6. Display with touch screen

Page 23 OMICON3_v34
 7

10

11

Rear and left side of Icon-3

7. USB connectors
8. RJ45 (network) connector
9. Power connector (12V DC input)
10. Reagent connector (with cover)
11. ID label of analyzer with S/N and electrical data

Page 24 OMICON3_v34
Installing the analyzer
Icon-3 is a precision hematology analyzer. Incorrect handling or
accidental falling of the analyzer may damage parts inside and
could influence performance.
To avoid overheating of the device, avoid installation in confined
space. If the system detects overheating, safety functions will
disable operation. Ambient temperature being above 34°C (86°F)
for an extended time may cause the system over-heat.

1. Carefully remove Icon-3 from the shipping carton. Look for signs of
damage, such as cracks on the outer covers or loose/missing screws. If
you find such signs, please file a complaint to the shipping company to
be eligible for compensation and support from your local dealer and
from the manufacturer. Make sure you can find all the accessories listed
in the packing list.
2. Prior to powering on Icon-3, allow the analyzer to reach room
temperature to avoid dew condensation. Sudden temperature changes
may cause dew to condensate on colder internal structures and can lead
to damage of electronic components.
3. Place the analyzer on a desktop bench and find a nearby grounded
power outlet. Please avoid power extension cords, use direct
connection to the power outlet. Always use the power supply packaged
along with the analyzer.
4. Connect the power supply to the socket on the rear plate of the
analyzer.
5. Connect the power cord to the power outlet.
6. Remove the protective foil from the analyzer’s front.
Attention
If you experience any error, like smoke, immediately disconnect the
power cord from the power outlet.
Use a fire extinguisher if necessary.

Page 25 OMICON3_v34
User serviceable parts
Attention
There are no user serviceable parts inside the analyzer. Please
do not attempt to open or disassemble the analyzer to avoid
electric shock or injury and will void the warranty.
Attention
Only qualified Service Personnel are allowed to perform
adjustment and repair procedures related to internal
components.

Connecting peripheral devices

Icon-3 offers 2 USB sockets for connecting external peripheral
devices. To expand USB connectivity options, you can connect
any standard USB HUB.

Keyboard (optional)
Icon-3 supports connecting external USB keyboards
that can facilitate data entry. The keyboard can be
connected any time.

Mouse (optional)
Icon-3 supports connecting a USB mouse. The mouse can be
connected any time. If a mouse is connected, the touch screen
remains operating, yet a small arrow icon will be displayed to
track the movement of the mouse.

Bar code scanner (optional)

You can connect a USB bar code scanner.

USB flash drive (optional)

You can connect a USB flash drive to save reports, archive
settings and database content. The USB flash drive is also
suitable to review and import data stored externally.
The USB devices should use FAT32 file system to be
compatible with Icon.

Page 26 OMICON3_v34
USB Wi-Fi Dongle (optional)
The device offers connectivity options to wireless networks
(sending measurement reports via email). Network settings must
be revised. The analyzer software supports a limited number of
Wi-Fi dongles.

Attention
It is not guaranteed that any random Wi-Fi dongle will work
with the analyzer.
Supported models:
- AmbiCom WL250N-USB (Chipset: Ralink RT3070)
- EnGenius EUB9707 USB Wi-Fi adapter
- LM Technologies – LM006

Network (“Ethernet”)
Connect the cable (not included) from the computer network to
Icon-3’s RJ45 socket. Network settings must be revised.

Reagent pack
The Norma Icon-3 reagent pack provides
sufficient reagent to run a specified number of
tests with Icon-3. The pack contains all
necessary reagents.
Waste bottle is not included.

Hematology reagent waste must be considered biohazard

material. Always follow local regulations regarding disposal of
used consumables, and reagent.

Page 27 OMICON3_v34
Reagent bottles
Norma Icon-3 is also suitable to run using individual reagents, external reagent
containers, bottles. Care must be taken when connecting reagent bottles to the
system. Always pay attention to match the right line with the correct reagent. It
is possible to shorten the tubes as necessary.
Assemble the reagent bottle caps following the sketch below:

Each tube is equipped with a label indication which bottle to connect it to. The
caps will match the standard Icon-3 reagent bottles.
Rear view (from tube side) of the reagent connector:

Attention
For best results and performance, place the reagents to the same
level (on the same desk) as the analyzer.

Analyzer packaging material

Retain the packaging for return and storage.

Page 28 OMICON3_v34
Power
External power supply
Icon-3 can only be used with the supplied
external power supply. The power supply
generates 12 VDC required for operation of
the analyzer.
The power supply is able to operate between
90-264 VAC @ 47-63Hz. No setting is required for input voltage selection. The
power supply has standard input and output connectors.
Upon connecting the power supply, Icon-3 is in low power consumption mode
and ready for operation.
Always use a grounded power outlet to avoid the risk of an electric
shock, and to ensure reliable operation.
An unearthed power outlet may make the analyzer sensitive to
external electrical interferences and may impair operation.

Power button
It is located on the right side of the beveled front
panel. When the external power supply is
connected both to the analyzer and to the mains
outlet, the analyzer can be turned on by pushing
the START button.

Page 29 OMICON3_v34
Power on
The single push of the START button will power on the electronics and Icon-3 will
display the welcome screen and the main menu automatically.

When Icon-3 is turned on, the screen remains dark, only backlight illumination
can be seen at the edges of the screen. This is normal. After a few moments Icon-
3 will show the welcome screen and load the SW when it is ready the main menu
will appear.

Power off
Icon-3 is a sensitive device with liquids inside. A simple power off might leave the
system in a state that can represent potential risk to moving components and
liquids inside.
Therefore, Icon-3 has a programmed power off sequence. It is recommended to
always follow the programmed power off sequence to avoid unreliable operation
of the structures inside the analyzer.
Icon-3 can be turned off by holding any point of the screen for 3 seconds and
initiating Shutdown in the submenu. To power off the analyzer, select
“Shutdown”. The automatic process will start, and the analyzer is safely powered
off within 30 seconds. Do not interrupt this sequence.
It is strongly recommended to power off the analyzer every day,
at the end of the daily routine. This will save electricity and
ensures that the analyzer operates reliably on a day to day basis.

Page 30 OMICON3_v34
Emergency power off
If necessary, Icon-3 can be powered off by holding the power button for 4
seconds. This method skips the preprogrammed Shutdown.
Performing an emergency power off can leave the analyzer in an
undetermined state. Not operating the analyzer after emergency
power off can result in malfunction.
Please contact your maintenance personnel to avoid damage to
internal components.

To completely and immediately power down Icon-3, remove the power cord plug
from the mains outlet or the power connector from the back of the analyzer.

Handling reagents
Icon-3 operates with special reagents. The reagents have been carefully designed
to meet the requirements of the analyzer. Icon-3’s quality assurance system
requires the use of these special reagents. Icon-3 recognizes and accepts genuine
reagents only.
Reagents are sensitive substances and as such require careful handling.

Precautions about reagents

Reagents are considered chemicals and do arrive along with respective package
inserts and MSDS. Always follow instructions of the reagents concerning reagent
handling.
It is recommended to wear protective gloves when installing and
replacing reagents to avoid contaminating reagent tubes
immersed into the reagent bottles.
Always rinse reagent tubes at first installation using clean water to
avoid contamination of reagents. After rinsing, wipe the outside of
the tubes to be immersed using clean, lint-free tissues.

Reagent characteristics
Icon-3’s original reagents do not contain any environmentally hazardous
substances.

Page 31 OMICON3_v34
Blood samples
Icon-3 is able to process whole blood human samples.
Proper handling of a hematology sample is of key importance for accurate,
dependable and reproducible results. Blood is a living tissue composed of cellular
structures suspended in liquid plasma. The cellular structures are composed of
cell membranes with liquid and intracellular structures inside. Hematology
analyzers are designed to detect, calculate and classify these cellular bodies and
their content. As the cells are actually alive in the meaning of active chemical
interaction with their environment, keeping them close to their ideal
environmental conditions is important for correct analysis. Blood samples
intended to be analyzed for hematology purposes are sensitive to temperature,
anticoagulant quantity and quality, and mechanical effects.
Follow the guidelines below for optimal sample handling.

Taking the sample

Collect venous blood using (preferably K2- or K3-EDTA-prefilled vacutainer; 1.5-
2.2mg/ml) anticoagulant collection tube.
Hematology sampling tubes have the anti-coagulant prepared inside the vial in
the form of liquid or gel. To ensure the correct amount of blood that can be
treated with the pre-dosed anti-coagulant, sample vials are shipped with vacuum
inside that ensures aspiration of the right amount of blood during the original
sampling process.
Sample vials also have a mark indicating the optimal sample level for the anti-
coagulant already included in the sample vial.

An EDTA quantity below or above the recommended ratio will

cause false or no results due to improper chemical treatment of
blood cells.

Rapidly and thoroughly mix the blood with the anticoagulant; do NOT shake the
vial for mixing. The anticoagulant requires approximately 15 minutes for taking
its required effect on the sample. Running the sample within the reaction time
of the anticoagulant may result in false cell counts and improper differential
results.

Page 32 OMICON3_v34
Transporting and storing samples
For best results, blood samples must be run within 8 hours from venipuncture if
stored at room temperature.
- Samples should be stored upright at room temperature for not more than
12 hours.
- If samples need to be transported after collection, provide a cooled
environment (2-8°C).
- Hematology blood samples must not freeze. Avoid direct contact of sample
containers and cooling agent (cold surface, ice pack, etc.).
- Samples can be stored refrigerated (between 2-8°C) for not more than 24
hours prior to analysis.

Sample age
To get the best WBC differential results, samples should be analyzed between
15 minutes and 8 hours after blood taking. This time period can be extended
up to 24 hours, if samples are kept refrigerated between 2-8°C.
- If a sample is kept refrigerated, remove it from the fridge, and let it rest at
room temperature for at least 15 minutes before analysis. Measuring cold
sample may affect WBC differential results.
Analyzing samples beyond 24 hours after taking is not recommended.

Preparation for analysis

Follow these guidelines for best performance.
- Do not place samples on rockers/homogenizers, because it may
negatively affect WBC differential results.
- Sample temperature must be between 15-28°C. Lower temperatures will
interfere with homogenization, higher temperature may induce faster
degradation of cells.
- Samples must reach room temperature in a natural manner. Do not heat or
directly warm the vials not even by holding them in your palm.
- Samples must not be mixed while cold. Doing so may physically damage the
cells. Let the vials stand in their holder upright for 15 minutes before
running them on the analyzer.

Page 33 OMICON3_v34
Proper Sample Mixing prior to run
Samples must be homogenized prior to analysis by 5-7 inversions of the vial.
Follow the steps below:
1. Tilt the tube carefully looking for clots in the sample – if clot found
refuse the sample from analysis.
2. Invert the tube: turn it upside down, allow the blood flow over
completely (1-2 seconds), then turn it back.
3. Repeat tube inversion another 5-6 times.
4. Run the sample immediately.
5. If you want to rerun a sample within a few minutes, invert the sample
tube just once, and initiate sampling.
Do not shake or drop the vial, this will form bubbles inside.
Do not apply vortex mixing.
Do not place samples on rockers/homogenizers, because it may
negatively affect WBC differential results.

Important factors for sample handling:

1. Running too fresh samples – taken in 15 minutes – may affect WBC
differential results. Wait 15 minutes before analysis.
2. Analyzing a sample without homogenization will result in an incorrect
report. The analyzer has no sensor to detect lack of homogenization.
3. Do not use an automatic sample mixer/rocker, since it applies
mechanical stress to the cells continuously which may negatively affect
WBC differential results. For the same reason, do not invert the sample
tube more than 7 times. Vigorous mechanical mixing weakens cell
membrane, especially NEU cells are sensitive to mechanical mixing.
4. Doing less than 4 inversions may leave the sample in a non-
homogenous state.
5. If a sample is kept refrigerated let it rest at room temperature for at
least for 15 minutes before analysis. Measuring cold sample will affect
WBC differential results.

Page 34 OMICON3_v34
Bubbles in sample
If bubbles are present in a sample, the amount of actual sample processed by
the analyzer may be less than required, and the analyzer may falsely report
incorrect values.
 Such sample should relax for 10 minutes before analyzing it.

Sample handling
Blood samples must always be considered as biohazardous and
infectious biological material.
It is recommended to wear protective gloves and goggles.

Spilled blood must be cleaned up as soon as possible, and the surface it got in
contact with must be cleaned with a suitable sanitizer. Same applies to blood
dried onto surfaces. Always wear protective gear even when you are cleaning dry
blood from surfaces.

Page 35 OMICON3_v34
Menu system
The screen area
Icon-3’s information display screen can be divided into four areas:
1. Status bar
1
Displays active menu and
instrument status 2
2. Page count area
(appears if left-right swipe is
available)
3. Main information
4. Quick links
Displays further functions
available related to displayed 3
data

Page 36 OMICON3_v34
Menu tree
Run open or closed tube samples,
Sampling
Daily routine Calibration, QC, FastBlank
Results Database functions

Prime & Drain, Clean, Diagnose,

Maintenance
Management General
Service Service Personnel Only

Pack Pack usage

Reagents
Individual Individual reagent containers, usage

Date / E-mail / Printout / Printout

System settings Formats / Network Printing /
Options Customization / Patient Profiles / LIS
Customize Language / Units / General settings

History Operation log

System Product info / Hardware info / SW
About
upgrade / Database records deletion

Gestures
Icon-3’s touch screen user interface allows operating the analyzer with light taps
and swipe actions listed below.

Taps (quick touch and release over a certain point)

Hold (touching a certain point and holding your finger there for
2-3 seconds before releasing it)

Swipe (quickly moving your finger along the screen without

lifting it)

Page 37 OMICON3_v34
All actions (touch, hold and release) are acknowledged by a small circular symbol
appearing at the point where the user tapped the screen, and an audible beep is
head if sound was enabled.
Using the above basic actions, Icon-3 can interpret various combined actions, so-
called gestures.

Tap
Touching (tapping) an active area (icon, data
input field) will activate the corresponding
function, or open a sub-menu. For data input
fields, an on-screen keyboard is displayed at the
top or bottom quarter of the screen depending
on the position of the data input field.

Swipe
Icon-3 is able to display data that spans over
several screens (pages). Such pages are indicated
with small rectangles in the center near the top
half of the screen.
To switch (scroll) between such screens, you
need to perform a sweeping gesture by lightly
touching the screen at any point of the screen
showing data, and quickly sweep your finger in
the direction of the intended scrolling action (up,
down, left, right). The screen will be scrolled in
the requested direction.

Page 38 OMICON3_v34
Hold
To access functions related a specific area, or to
access special functions, you can touch and
hold a specific point on the screen. This action
will trigger displaying special local menus
offering services related to the contents of the
screen.

On-screen keyboard
When you select to enter data, an on-screen
keyboard will be displayed at the top or the
bottom quarter of the screen. The position of
the keyboard depends on the position of the
data input field to avoid covering the field with
the keyboard.

Page 39 OMICON3_v34
Data input
Alphanumeric input
Input fields are marked with an
underscore. Tapping into any field allows
editing data. The on-screen keyboard
will be displayed either in the top or in
the bottom quarter of the screen to
make sure that the input filed remains
visible.

The cursor is indicated by a light underscore below the character.

The on-screen keyboard allows changing symbols entered by changing the keys.
The keyboard can be changed by swiping left or right to reveal capital letters,
small letters and symbols.
SPACE adds a space at the cursor.
CLEAR deletes the entire field.
BACKSPACE erases the character left of the cursor.

External keyboard
If an external keyboard is connected to Icon-3, then keystrokes from the external
keyboard will be used to enter data into input fields. Always the English keyboard
layout is used to interpret keystrokes.

Page 40 OMICON3_v34
Barcode input
If an external barcode scanner is connected, then the read ID will be entered as
Sample ID for the consecutive measurement.
This function is only active if the measurement function is activated. Barcode
scanner data will not be interpreted as data for any other field.
To input barcodes:
- Make sure the analyzer is measurement mode (ready to start)
- scan the barcode with the handheld scanner
When a barcode has been recognized and interpreted, the bar-code will be
entered into the Sample ID input field.

Numeric input
Some data fields may require modification on a larger scale. For this purpose,
Icon-3 offers another intuitive setting method.

Symbols ---, -- and – buttons will have decreasing effect on first, second and the
third digit, respectively.
Symbols +, ++ and +++ buttons will have increasing effect on first, second and the
third digit, respectively.

Page 41 OMICON3_v34
Description of icons displayed

[Daily routine] Access measurement mode and results

[Management] Access point of maintenance functions

[Reagents] Reagent menu

[Options] Settings

[System] System administration utilities

[Home] Back to the Main menu

[WiFi] Wi-Fi network available

[WiFi] Wi-Fi network connected

[ETH] Wired network available

[PrinterThermal] Thermal Printer connected

[PrinterPCL] PCL5/PCL6 Printer connected

[Printer] Unknown Printer connected

[Loading…] The analyzer is busy

[QuestionMark] Measurement mode selection

[Gift] New results are available

[Vial] Available measurements in the pack.

[E-mail] Send selected records in an email.

Page 42 OMICON3_v34
 [TSF] Save records into TXT file (Tab Separated File)

[PDF] Save selected results into PDF file

[LIS] Send results to LIS

[Uncheck] Check/uncheck selected elements.

[Drop] Discard elements

[Reset/Load] Reset to original or default values./ Load data from external

USB drive

[Accept] Confirm and accept elements

[Print] Print selected records

[Eject] Remove tube from sampling rotor

[Read] Read (scan) QR code

[SelectionStart] Activates multi-selection

[SameDay] Selects records of a specific date

[SameSampleID] Selects records of a specific SampleID

[CV] Calculate CV of selected results

[Jump] Jumps to given date in records database

[LoadW] Load wallpaper

[SaveRAW] Save raw measurement data

Page 43 OMICON3_v34
 [ShutDown] Initiates shutdown sequence

[ClosePage] Closes context menu

[ERMode] Activates ER mode

[AdminMode] Deactivates ER mode

[Calibrate] Loads mean of parameters as calibration target (selected

records)

[LoadProfiles] Load Profiles

[SaveProfiles] Save Profiles

[AlarmClock] Automatic timer for specific actions is on. Tap for details.

[Full] External liquid container is full. Tap for details.

[Unsent] There are unsent records in the message queue (network error)

Page 44 OMICON3_v34
Setup
Icon-3 comes preprogrammed with the operating software, and has most its
options set to standard values, values that suits most laboratories.
However, you can customize these settings to make Icon-3 fit into your daily
routine even better. Here is a brief list of options that you are recommended to
adjust or verify to make the use of the analyzer simple and convenient.

Initial setup
Below is a recommended sequence of settings so that you can start using the
analyzer easily:
- choose a language for your analyzer
- practice gestures used on the screen
- set time and date
- set up your Laboratory information and measurement units
- set up your network and connectivity (email) (if available)
At the first startup a practice wizard starts where you can practice the usage of
analyzer (gestures, setting changes) and adjust date and time. You can skip each
stage; you can leave the setup wizard at any time. You can also (re)run the wizard
at any time later on.

Language
Icon-3 software supports various languages. The default is English. To change:

 [Customize]  (Page 2)
The second page of Options/Exterior will display the list of available languages.
Tap the checkbox to the right of the preferred language. All text displayed will
immediately be changed to the new language. Your changes are immediately
saved.

Page 45 OMICON3_v34
Time and date
Set time and date.

 [System Settings]  (Page 1)

Your changes are immediately saved.

Laboratory specific information (printout contents)

 [System Settings]  (Page 3)

Set the name of your laboratory or the text you want to appear on reports
generated by Icon-3.
Your changes are immediately saved.

Report output (email)

Icon-3 can produce reports ready to print and can send them to any recipient
you defined.

 [System Settings]  (Page 2)

You can also choose to create and print reports locally. For this, you need to
connect Icon-3’s dedicated thermal printer or a PCL5/PCL6 printer (via network
also supported).

Page 46 OMICON3_v34
Settings – Customize
Appearance
[Page1]
You can disable the visual feedback of
touchscreen gestures.
You can enable/disable audible touch
feedback.
You can change the background image.
To use Custom wallpaper, use “Custom”
setting, and load your wallpaper by accessing
local menu (tap-hold screen) and tapping the
“Load Wallpaper” icon.

The wallpaper file must reside on a USB memory device, named

“CustomWallpaper.png”. Resolution must be 800x1280 pixels.
Do not use clear white or clear yellow images: this will impair
screen readability.
Icon-3 will confirm the new wallpaper file or will display an error
message if the image is not of the right size, format, or it cannot be found in the
root folder of the USB memory device.

Page 47 OMICON3_v34
Languages
[Page2]
Language of the user interface can be
changes. Changes have an immediate effect.

Units
[Page3]
It also allows changing measurement units for
cell count (WBC, RBC, PLT), HGB, HCT/PCT.

Page 48 OMICON3_v34
System Settings
This menu allows setting operation related
parameters.

Date and time

[Page1]
This menu allows changing the current date
and time by pressing Done button.

Email settings
[Page2]
This screen provides fields to set e-mail
account parameters used for reporting:
- “Email to”: Default “To:” address
- Sender e-mail address (“From:”)
- “From:” email account password
It is necessary to define SMTP settings
(default provider is Google because of
compatibility issues).
For details, please consult your email
provider. Gmail may require enabling “less
secure apps” to allow the device to manage
emails.

Page 49 OMICON3_v34
Some examples:
- Yahoo: smtp.mail.yahoo.com; 465 port; SSL
- Google: smtp.gmail.com; 465 port; SSL
- Office365: smtp.office365.com; 587 port; STARTTLS
It is possible to choose to automatically generate and email the report in PDF
format.
Test the e-mail settings by tapping the “Test E-mail settings” button.

Network preferences
Icon-3 allows connection to networks
over Wi-Fi or cable. Some processes
may fail if they start communication
over the wrong interface.
Access Local Menu (tap-hold screen)
on Email settings page to change
Network preferences setting.
It is possible to choose which interface
(WIFI/Ethernet) to use for various
activities:
- Remote Access
- Email transmission
- LIS transmission
- Network printing
Preferences can only be applied if
both wired and wireless networks are
available.

Page 50 OMICON3_v34
Printout Settings
[Page3]
There is a possibility to define some
standard messages or comments to be
included in a report generated by the
analyzer.
It is possible to enter a header composed
of 5 lines that will be printed on all reports.
These five lines can be left, center or right
aligned.
Enabling “AutoPrint” will make Icon-3 print
reports after the results are available.
(Requires connection of a printer)
Icon-3 can use ESC/POS language for
unrecognized printers.
Defining printout signature(s) will make
Icon-3 print line(s) with the defined
value(s) on the bottom of page.
(Signature’s visibility on A4 formats
depends on corresponding setting.)
Icon-3 can be forced to use ESP/POS language for unrecognized printers.
WARNING
Forcing an incorrect language to a printer may result in scrambled
printouts, and empty pages, even one single symbol per page!

Page 51 OMICON3_v34
Printout Format
[Page4]
It is possible to choose between 4 different
printout formats.
Select which parameters you want to
appear on the printout, and the order of
appearance can also be customized.
Note: parameters cannot be moved within
parameter groups. Parameter groups are
separated by horizontal lines.
It can be chosen whether you want the PDF
reports to be colored or not, hide
histograms, hide technical flags, print the
technical data and show or not the
signatures on the printout.

Page 52 OMICON3_v34
Color output is available for PDF, color printing depends on printer and its driver
capabilities (PCL6).

Page 53 OMICON3_v34
Network Printing
[Page5]
It is possible to use a network printer as a
default printer – define the IP address and
Port (consult your system administrator or
printer manual for details) of the printer.
Select PCL5 or PCL6 language. Only these
languages are available for network
printing.
When all settings are made, you can print a
Test page to verify the setup.

WARNING
Forcing an incorrect language to a printer may result in scrambled
printouts, and empty pages, even one single symbol per page!
An incompatible printer may not even react to wrong messages,
this way you get no feedback about the incompatibility.

It is possible to use Print server (PrintServer software is available from Norma) as

a default printer. For more information, consult your distributor.
PrintServer allows the analyzer to use a remote PC (running Windows) and its
connected printer to print reports. You need to define the IP address and Port
(consult your system administrator) of the PC running the Print Server.
When all settings are made, test page can be printed to verify the setup.

Page 54 OMICON3_v34
Customization
[Page6]
Defining Comment 1-3 values will change
header of comment fields on printouts
and user interface as well.
QC charts include only 9 parameters
(WBC, LYM%, MID%, GRA%, RBC, HGB,
MCV, PLT ,MPV) if Short QC parameters
mode is selected.
Used Reagent volume: you can define the
volume (in Liters) of the external
container collecting waste liquid. When
the free volume drops below 0.3L, there
will be a Full container symbol in the
upper right corner of the screen. If you set
0 as volume, Icon-3 will not display a
warning at all.
Enabling QC measurement warning allows
the system to pop up a message about QC
measurement importance after every
daily startup.
Enabling Interpretation flagging option shows current interpretation flags for
results (screen, printouts).

Page 55 OMICON3_v34
Profiles
[Page7]
Minimum and maximum values can be set
for each measured parameters. Measured
values will be verified against these limits.
Icon-3 offers 8 slots (Human, Male,
Female, Profile 4-8). Swap between
profiles by swiping up/down.
All limits can be changed. You can define
custom names for Profile 4-8.
To backup/restore Profiles tap the “Load
Profiles” or “Save Profiles” icon by
accessing local menu (tap-hold screen).

Page 56 OMICON3_v34
LIS (Laboratory Information System)

[Page8]
Icon-3 is capable of transmitting reports
using HL7 v2.5 protocol to a host
computer.
This page allows setting HL7 server IP
address along with the communication
port.
Automatic transmission of results can be
enabled.
By enabling repeating of Sample ID as
Patient ID the transmitting report will
contain standard HL7 PID field which
includes the sample identification string.
Keeping HL7 connection open after
transmission can be enabled.
HL7 message format is depends on
selected version. For more information
requests for HL7 transmission protocol
document.
This page also allows setting up Remote Access parameters. For details, please
contact your Service Personnel.
With LIS resend option you can set when the software sould resend unsent LIS
messages (in every 1/4/24 hours or never).

Page 57 OMICON3_v34
Measurement Settings
The detector used for sample detection in open mode close to its operation limits
below HGB = 45 g/L. A very thin (low HGB) sample or a sample without particles
(not blood) can trigger this warning. To avoid these limitations, you can disable
the open mode sample (blood) sensor.

This way the system will use a preset volume of sample travel and will not use
sample sensor. The disabled OPEN sample detector is marked with red
highlighted BS (Blood Sensor) symbol on the top of the screen.

Page 58 OMICON3_v34
Setting up reagents
Icon-3 requires reagents to run. Connected
reagents can be managed from the
Reagents menu. Reagents menu has two
separate branches: one for packed and one
for individual (“Bulk”) reagents.

Reagent: Pack
Tap on the Reagent icon in the main menu
then select “Pack”.

A list of reagent pack will be displayed. The

active (currently used) pack will have a
green background. Inactive packs have no
coloring, expired or empty packs will have a
dark red background.
Swiping left on a row will bring up detailed
information about the pack: LOT number,
expiration, part (ordering) number, and
level of the pack with consumption data,
open bottle stability data (based on
installation date) and usage statistics.
Tap and hold any area of the screen to
display the local menu when reagent data
are displayed. Tap the “Deactivate” icon to
stop using a pack. Tap the “Activate” icon to
start using a pack.

Page 59 OMICON3_v34
To add reagent packs to the system:
Icon-3 offers entering reagent pack data
using the onboard camera. Norma provides
reagent packs with QR codes.
To activate QR code reading sequence:
- tap and hold any point on the
screen.
- tap the small camera icon. “Read
QR”
The screen will change, and you will see a
live image of what the camera “sees”. The
camera is located in the center of the letter
“o” in the “Icon” text at the top right corner
of the front panel.

Hold the QR code in front of the analyzer,

making sure that the code is not curved or
bent. The QR code should be located in the
center of the live image. The camera has a
fixed focus find the best distance to read
the QR.
Icon-3 will acknowledge the QR code with
an audible tone. The data will be entered as
a new reagent pack. If you scanned a code
that already exists, Icon-3 will show a
message.
To load codes from a USB flash drive, use
the “Load QR” icon.

Page 60 OMICON3_v34
Reagent: Individual Reagents
Tap on the “Reagent” icon in the main
menu and then select “Individual
Reagents”.
A list of individual reagents will be
displayed.
You can see the details of actual reagents
by tapping the row of a specific reagent.
The active (currently used) reagent will
have a green background. Inactive reagents
have no coloring, expired or empty entries
will have a dark red background.
Swiping left on a row will bring up detailed
information about the reagent: LOT
number, expiration, part (ordering)
number, and level of the container with
consumption data.

Tap and hold any area of the screen to

display the local menu when reagent data
are displayed. Tap the Deactivate icon to
stop using a reagent container. Tap the
Activate icon to (re-) start using a reagent
container.

Page 61 OMICON3_v34
To add individual reagents to the system:
Icon-3 offers entering reagent data using the
onboard camera. Norma provides individual
reagents with QR codes.
To activate QR code reading sequence:
- tap and hold any point on the
screen.
- tap the small camera icon.
The screen will change, and you will see a live
image of what the camera “sees”. The
camera is located in the center of the letter
“o” in the “Icon” text at the top right corner
of the front panel.

Hold the QR code in front of the analyzer,

making sure that the code is not curved or
bent. The QR code should be located in the
center of the live image. The camera has a
fixed focus find the best distance to read the
QR.
Icon-3 will acknowledge the QR code with an
audible tone. The data will be entered as a
new reagent pack. If you scanned a code that
already exists, Icon-3 will show a message.
To load codes from a USB flash drive, use the
“Load” icon.

Page 62 OMICON3_v34
Manual QR code entry
In some cases, the QR code could be damaged. In this situation the user can enter
the QR code data manually.
Activate local menu in reagent pack list menu or in diluent, lyse or system
solution list menu.
Enter all data located around QR code into the corresponding data field.
After that tap the button below the data to confirm data.
The analyzer will not allow more than three false data entries. The analyzer must
be restarted to try again.

Page 63 OMICON3_v34
Network Settings
You can make the most of Icon-3’s services if
you let it connect to a network with access to
the Internet, so that it can create and send
reports in emails, transmit data to your
laboratory information system and update
software when necessary.
Network availability is displayed in the top
row of the screen.
When Wi-Fi is available (a USB Wi-Fi adapter
is connected) then a little signal strength icon
appears in the top row.

When wired network is availabe, a network

plug icon is displayed.
Tapping on this icon brings up the list of
available wireless networks.
Tap on a network to access its details.
Tapping on the X in the row of a network will
remove it from the list of networks.

Page 64 OMICON3_v34
Wi-Fi settings
Network connectivity supports the following
encryption protocols:
- open
- shared
- WPA2 Personal
- WPA Personal
DHCP is always assumed for Wi-Fi.
If required, you can enter the password for
the network, and then tap “Join” to start
connecting.
For details on the network, please contact the
local network administrator.

Wired network settings

Access settings by tapping the network plug
icon in the top of the screen.
Actual settings are displayed in the lower half
of the screen. Enter your settings in the upper
half of the screen.
If DHCP is enabled, you do not need to specify
network related data.
If DHCP is not supported, please contact your
network administrator for settings.

Page 65 OMICON3_v34
Daily operation
Your daily routine will mostly consist of
powering on the analyzer, running samples
with unique sample ID’s and creating reports.
It is good laboratory practice to run QC material
on a daily basis to ensure and allow controlling
the performance of the analyzer on a day-to-
day basis.
You will most probably create reports of the
samples run and occasionally you will need to
find earlier results of individual patients.
All these tasks are outlined below to give you
an easy to follow guide and make laboratory
work routine and fun to do.

Power on
Icon-3 will mostly be waiting in stand-by mode.
Push the START button to wake up the analyzer,
the status ring on the top will change color.
The user interface will be displayed shortly, and
the analyzer is ready for work.
The fluidic system will always require initialization,
a programmed startup. This is indicated by a yellow analyzer in measurement
mode.
Tap the yellow icon to start the initialization.

Page 66 OMICON3_v34
Running samples
To start measurements, tap “Daily routine” and then tap „Sampling”.
It is recommended to verify the accuracy of measured parameters. The practical
method is running a QC measurement using control material.

Closed tube mode

The opening on top of Icon-3 for Closed vials is designed to receive
blood collection tubes of defined dimensions with caps on.

To avoid personal injury, do not put your finger into the opening.
Avoid placing objects different from a blood collection vial to avoid
damage to the analyzer.
Avoid putting tubes without caps into the sampling mechanics.

To run samples, you need to enter the “Daily routine” menu.

Enter the sample ID to the input field using the

on-screen keyboard or an external keyboard.
Select a profile by tapping the Profile list and
place the closed sample vial into the sample
opening on the top of the analyzer.

Page 67 OMICON3_v34
 Avoid putting more than one barcode label onto the blood
collection tube to avoid the tube getting stuck in the sampling
mechanics.
Icon-3’s sampling mechanics is equipped with a cap detector.
Cap detector operation may be impaired by additional labels put
on the sample vial, and Icon-3 may refuse to run such tubes.

Tapping the analyzer symbol in the center will start the measurement.
Icon-3 will lower the sample vial into the sampling mechanics and will take a
sample with its built-in cap piercing needle.
When the sample has been taken, the vial will be returned to the Operator.
Results will be available in a minute.
A new result will be indicated by a small icon in the lower right
corner of the screen. Tapping this icon will take you to the Results
screen and data will be displayed on the screen.

Page 68 OMICON3_v34
Open tube mode
To run samples in Open tube mode, the blood collection tube must
not have its cap on.
Always follow laboratory practice by wearing necessary protective
gear to avoid getting in contact with blood samples, which must be
treated as potentially biohazard material.

To run samples, you need to enter the “Daily routine” menu.

Enter the sample ID to the input field

using the on-screen keyboard or the
external keyboard. Select a profile by
tapping the Profile list.
Tap the “open mode” button.
Icon-3 will present the open sampling tip
above the START button.
Icon-3 is ready to run the sample in open
mode.
Guide the open vial so that the sampling
tip is immersed in the sample.
You can start the measurement by
tapping the color “Press To START” icon
on the screen.
Tapping the color symbol on the screen
will start the measurement, and Icon-3
will take the necessary amount of
sample from the vial.
After sampling is done, the analyzer will give a tone and the mechanical start
button will lit up in red color and the tip will be retracted and washed. You can
now take the sample vial away. Results will be available after a minute.

Page 69 OMICON3_v34
 During sampling, always pay attention to hold the vial parallel to
the flexible tip.

Never force the tip to bend in order to

avoid accidental contact with sample upon
retraction of the flexible tip.

A new result will be indicated by a small

icon in the lower right corner of the screen. Tapping this icon will
take you to the Results screen and data will be displayed on the
screen.

Page 70 OMICON3_v34
Results
Icon-3 can display results in two ways:
- in short form during measurement in the lower half of the screen;
- a full (detailed) view is accessible in “Results” (database)

Short (Quick) result

The results appear in the lower half of the screen. Only 10 parameters are
displayed. You can tap the values for details, and you can tap the histograms for
a zoomed view.
If flags are displayed, tap on the values to see flag messages.

Page 71 OMICON3_v34
Full result (Full screen)
Full, detailed results are available from the Main menu under “Daily routine”/
Results.
Flags are displayed written in yellow color.

Page 72 OMICON3_v34
Flags
The screen below intentionally contains an error flag (red flag).

Technical flags
Icon-3 is able to display technical warning flags. Flags can appear in various
locations, depending on significance and relevance. Flags by the Sample ID refer
to sampling or sample handling mistakes. Flags displayed in WBC and RBC groups
refer to parameter related irregularities. Technical flags rather give guidance for
the user, an indication of not operating the analyzer as recommended.
Flags have different levels of significance. Each flag has two confidence levels. As
long as results are not negatively influenced by the detected conditions, results
will be displayed along with the flags. As soon as severity of the problem goes
beyond safe result interpretation, and would impact readings, values will be
dashed out.

Page 73 OMICON3_v34
List of Technical Flags

Improper Voltage
Your analyzer might be operating outside the described
Meaning
environmental conditions.
Type RBC, WBC
Effect on result Results are NOT displayed.
Please observe environmental requirements. Maybe
Resolution
cleaning is due.

Inadequate Lysis
The sample could not react to the chemicals in the lysing
Meaning
reagent.
Type WBC
Effect on result WBC, Diff# and Diff% values are marked with *
Resolution Check Lyse in external tubes. Rerun the sample.

Noise
Meaning Only original reagents should be used with Icon-3.
Type WBC, RBC
Effect on result Results are NOT displayed.
Resolution Verify reagents.

Low sample volume

There was an inadequate quantity of sample in the
Meaning
sampling vial.
Type Technical
Effect on result Results are displayed.
Rerun the sample if possible. Please observe minimum
Resolution
sample volume guidelines.

Overload
Inadequate volume of reagents, or reagents improperly
Meaning
connected.
Type RBC, WBC
Effect on result Results are NOT displayed.
Resolution Verify right connection.

Page 74 OMICON3_v34
 Linearity Range Exceeded
The results are beyond the linearity range of the
Meaning
analyzer.
Type RBC, WBC
Effect on result Results are displayed.
Resolution Run the sample after 1:1 predilution.

Unstable HGB
Meaning Improper homogenization of sample.
Type HGB
Effect on result Results are NOT displayed.
Rerun the sample. If maintenance related cleaning
Resolution
actions have been omitted, please do them now.

Unstable HGB Baseline

Meaning HGB detection was unreliable.
Type HGB
Effect on result Results are NOT displayed.
If maintenance related cleaning actions have been
Resolution
omitted, please do them now.

Unstable Voltage
Inadequate sample kinked external tubes resulted in
Meaning
insufficient volume of reagents aspirated.
Type WBC
If the significance of the problem is LOW:
WBC, Diff# and Diff% values are marked with *
Effect on result
If the significance of the problem is HIGH:
Results are NOT displayed.
Please verify external reagent connections and rerun the
Resolution
sample.

Unstable Voltage
Inadequate sample kinked external tubes resulted in
Meaning
insufficient volume of reagents aspirated.
Type RBC
If the significance of the problem is LOW:
RBC, PLT and related values are marked with *
Effect on result
If the significance of the problem is HIGH:
Results are NOT displayed.
Please verify external reagent connections and rerun the
Resolution
sample.

Page 75 OMICON3_v34
 WBC Channel Dirty
Meaning Cleaning was omitted recently.
Type WBC
Effect on result WBC, Diff# and Diff% values are marked with *
Please clean the analyzer (“Open Cleaning”) and run a
Resolution
“Rinse” process

WBC Fallback
Inhomogeneous WBC concentration but evaluation has
Meaning
succeeded.
Type Technical
Effect on result Results are displayed only on technical view.
Resolution Rerun sample. Can be sample related.

3part Fallback
Inhomogeneous WBC concentration but evaluation has
Meaning
succeeded.
Type Technical
Effect on result Results are displayed only on technical view.
Resolution Rerun sample. Can be sample related.

Diff fallback
MID population is over 50% due to possible wrong
Meaning
distribution of high GRA population.
Type WBC
Effect on result WBC, Diff# and Diff% values are marked with *
Resolution Rerun sample. Can be sample related.

Blood Sensor Disabled

Meaning Open sampling blood sensor turned off by user.
Type Technical
Effect on result Results are displayed.
Resolution N/A

Page 76 OMICON3_v34
Interpretative Flags
This flagging function will display text if a given parameter is outside the normal
range. These flags will appear in the information box below the results.
Parameter Low flag High flag
WBC Leukopenia Leukocytosis
LYM Lymphopenia Lymphocytosis
GRA Granulocytopenia Granulocytosis
RBC Anemia Polycythemia
MCV Microcytosis Macrocytosis
MCHC Hypochromia Hyperchromia
RDW sd Anisocytosis
PLT Thrombocytopenia Thrombocytosis
MPV Microcytic PLT Macrocytic PLT

Page 77 OMICON3_v34
Reports
PDF
Icon-3 is able to send reports
ready to be printed via email or
is able to save reports to USB
Hard Disk, stick, etc.
Reports include all entered
patient data, along with
reported parameters,
histograms and additional
notes, comments created using
the analyzer during or after
analysis.

Note: if you choose to export one single result into one PDF file, then the
SampleID (if defined) will be added to the name of the PDF file. PDF export file
name is generated as follows: SampleID_DATE_TIME.PDF

Page 78 OMICON3_v34
Printer Thermal
Icon-3 is able to send report to
connected thermal printer. When
Icon-3 detects Thermal printer is
connected proper
symbol will be shown
on status bar.

A printer report looks as shown on

the image to the right.

It is possible to hide histograms

from the printout. For details, see
Settings / Printout.

Page 79 OMICON3_v34
Printer PCL5/6
Icon-3 is able to send report to
connected printer which is
capable to interpret PCL5/PCL6
printer language. When Icon-3
detects PCL5/PCL6 compatible
printer is connected
proper symbol will
be shown on status
bar.

A printer report looks as shown

on the image to the right.

It is possible to hide histograms

from the printout. For details,
see Settings / Printout.

Note: Icon-3 supports a limited set of printer languages. The printer must
support one of the following languages:
- PLC5
- PCL6
- ESC/POS
Printers not supporting the above printer languages will trigger a printer symbol
with a question mark on the screen, and will print scrambled reports, or a lot of
empty pages.
Icon-3 can force the ESC/POS language for unknown printers.

Page 80 OMICON3_v34
Power off
A regular power off can be initiated at any time. Processes that actually run the
fluidic system cannot be interrupted.
To power off, press and hold any point of the screen for 3 seconds. A quick menu
will be displayed offering various actions including shutdown (power off).

Shutdown will prepare the system for a longer period of inactivity. The process
takes about a minute, after which the system will automatically power off,
leaving Icon-3 ready to be disconnected from the mains if necessary.
To clean the piercing needle during Shutdown process run the specialized
Shutdown with Needle Clean process from Management menu. See Shutdown
options below:
1. Shutdown (Location: Management/Maintenance/General Menu)
The analyzer will perform the regular shutdown procedure by washing the
Sampling Tip, priming a small amount of Diluent and rinsing the Shear Valve.

Or in submenu:

Page 81 OMICON3_v34
2. Shutdown with Needle Clean (Location:
Management/Maintenance/General)
The analyzer will perform the regular shutdown procedure with the additional
needle cleaning. An empty control blood vial with 2-3 ml of iHClean (hypochlorite
solution) must be prepared in advance.

Page 82 OMICON3_v34
ER mode
Icon-3 is able to run in ER (“Emergency Room”) mode. In ER mode user has
limited access to user functions.
The user can access Sampling, Results and Maintenance functions. This mode
allows operating the analyzer in an environment where users do not deal with
analyzer setup on a daily basis. Settings are however accessible with a password.

ER Sampling
Same operations are available like
in the “Daily routine” menu
“Sampling” submenu with
restrictions:
- mandatory Sample ID
function could be activated
by service personnel
- Auto-increment option could
be disabled by service
personnel
- Open mode option could be
disabled by service
personnel
- calibration cannot be
accessed

Additional feature is automatic QC mode detection. If existing QC LOT identifier

is entered into SampleID field, Icon-3 will mark the upcoming measurement as
QC measurement.

ER mode behavior can be set up in Service Menu. For details, see next pages.

Page 83 OMICON3_v34
ER Results
Same operations are available like
in the “Daily routine” menu
“Results” submenu with
restrictions:
- calibration results are
unreachable
Possible options in ER mode
(Service Setting required)
- Forced Sample ID,
Operator ID
- Pre-mixing of sample in
closed mode
- Disable Profile selection
(Human limits will be
used)
- Hide “Reuse previous
sample data” button
- Hide 3-part results
- Automatic Rinse,
FastBlank
- Adjustable FastBlank limits for WBC, RBC and PLT values
- Sampling menu is automatically displayed after 5 minutes of inactivity
- Hide auto-increment option
- Hide open mode

Page 84 OMICON3_v34
Switching between ER and Admin mode
User can change between ER and Admin mode by accessing local menu (tap-hold
screen).

Switching from ER mode to

Admin mode requires a
password.
The password is a series of 6
(six) “Tap” gestures.

Page 85 OMICON3_v34
Calibration
Icon-3 as any laboratory analyzer can be calibrated. For this purpose, Icon-3
offers two ways to perform this task. Icon-3 arrives to your laboratory factory
calibrated.
Calibration is necessary if laboratory standards require it, or when maintenance
actions require you to do so. You may need to calibrate upon installing new
reagents.

Target values
Calibration is performed comparing the reported values of the analyzer to a
known specimen, or standard. Hematology analyzers have their own calibrator
materials called Hematology Calibrators.
A calibrator material is made by using human samples mixed with specially
treated particles to guarantee stable values for parameters over the stability
period of the calibrator material. All calibrator products come with a list of the
target values of calibrated parameters.
It is recommended to use calibrator material called NormaCal3.
These target values represent the standard to which your analyzer’s reported
values are compared.

Page 86 OMICON3_v34
Mode-to-mode calibration
Calibrating Open Sampling Mode to Closed Sampling Mode
This analyzer has two separate sampling modes and each mode
has its own set of calibration factors. These modes can and have to
be calibrated separately.

To make sure that the analyzer reports identical values for open and closed mode
sampling of the same sample, the following method is recommended:
1. Make sure that the analyzer has been calibrated in closed mode using
calibrator material.
2. Run a live (human) sample in closed mode 3 times.
3. Go to Results, and calculate the mean values of WBC, RBC, HGB, MCV,
RDWcv, PLT and MPV for the 3 repeated measurements.
4. Note (write down) these mean values.
5. Start an open mode calibration.
6. Enter the values that you wrote down previously as target values.
7. Run the same live (human) sample in open mode 3 times.
8. Accept the calibration.
9. The two sampling modes have been successfully calibrated to one
another, thus the analyzer will be able to report matching results for
human samples.
Note: Step 3 – 6 can be substituted by using “Calibrate”
function on selected measurements via accessing local
menu (tap – hold screen).

Page 87 OMICON3_v34
Automatic calibration
Icon-3 offers an automatic
calibration method to keep the
process as simple as possible.
The steps of automated calibration
are as follows:
- enter target values
- run the calibrator
material a specified
number of times
- accept the calibration
result
Icon-3 can calibrate the below
measured parameters:
- WBC, RBC and PLT count
- HGB, MPV, RDW and MCV
value
Check the box in front of
parameters you want to calibrate.
Enter target values either by defining the expected values of the calibrator found
on the accompanying insert or, scan the special barcode containing all these data
using Icon-3’s built-in camera.

Page 88 OMICON3_v34
Select measurement mode (open or closed tube sampling), insert the vial with
the calibrator material into Icon-3’s sample opening or immerse the flexible
sampling tip into the sample and press START.
Icon-3 will mix and run the sample and will calculate the mean values of the
measured parameters. The mean value will be used to calculate the calibration
factors using the formula below
𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑟𝑟𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡
𝐶𝐶𝐶𝐶𝐶𝐶𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝(𝑛𝑛𝑛𝑛𝑛𝑛) = ∗ 𝐶𝐶𝐶𝐶𝐶𝐶𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝(𝑜𝑜𝑜𝑜𝑜𝑜)
𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑟𝑟𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚
Each sample run will be listed on
the screen, with each parameter to
be calibrated.
Consequent measurements
(samples) will be displayed on small
Levey-Jennings charts, each sample
represented by a small dot. This
screen allows a quick overview of
the process, displaying calculated
Mean and CV values.
Highlighted samples can be deleted
(“Drop”) from the list of
measurements.
Red highlight indicates that
accepting these values would push
the calibration factor to its 30%
limit. Red highlight is intentional to
demonstrate error.
“Reset” will clear values and cancel
the calibration process.

Page 89 OMICON3_v34
Manual calibration
Icon-3 also offers the option to
enter calibration factors manually.
Possible values are 0.70 .. 1.30.
This way the operator can modify
calibration factors parameters
individually.
Manual calibration can be a much
faster method than the built-in
automatic calibration service, but
care must be taken when changing
parameters manually.

It is recommended to verify the effects of the manual calibration

by running specimens with known values of measured parameters.

Each calibration factor can range from 0.70 to 1.30 allowing a ±30% range for
adjustment.

Page 90 OMICON3_v34
QC – Quality Control
Icon-3, just like any laboratory analyzer needs verification of its performance
from time to time. For this purpose, Icon-3 offers the Quality Control service.
Quality Control is a built-in tool offering an easy method to track the
performance of Icon-3. Enabling QC measurement warning allows the system to
pop up a message about QC measurement importance after every daily startup.

Expected values
Quality Control is performed measuring the same specimen over a period of
time. Hematology analyzers have their own control material called Control
Blood.
Control blood is made by using human samples mixed with specially treated
particles to guarantee stable values for parameters over the stability period of
the control material. All control blood products come with a list of the expected
values of parameters.
Please always observe the package insert of the control material;
such products require storage in a refrigerator. Prior to using the
control material, it must reach optimal (room) temperature.
Always follow the instructions accompanying the control product.

These expected values represent the standard to which your analyzer’s reported
values are compared. It is recommended to use control material NormaCont3+,
developed specifically for Icon-3.
Recommendation to
perform Quality Control
measurements after
turning on the analyzer – a hint
message is displayed on the
measurement screen after the first
entry each day, to remind users to
verify the analyzer’s performance by
running QC measurement with
NormaCont3+ control blood.
This function can be switched on and off. (Location: Options/Customization)

Page 91 OMICON3_v34
Assay sheets
Icon-3 offers entering QC Assay values via
QC codes using the onboard camera.
Norma provides Assay Sheet values in QR
code form as well. To read the QR code,
you will have to print it then present it to
the analyzer as described below:
- To activate QR code reading
sequence, tap and hold any point
on the screen.
- Tap the small camera icon.
The screen will change, and you will see a
live image of what the camera “sees”. The
camera is located in the center of the
letter “o” in the “Icon” text at the top right
corner of the display.

Hold the printed sheet in front of the

analyzer, making sure that the sheet is not
curved or bent. The QR code should be
located in the center of the live image. The
camera has a fixed focus find the best
distance to read the QR.
Icon-3 will acknowledge the Assay Sheet
with an audible tone. The data will be
entered in the QC mode available for
measurement.
Make sure to show one QR code at once,
so that the SW can read data properly.

Page 92 OMICON3_v34
Assay sheet data can also be entered
manually.
The list of QC materials can be seen with a
manual entry point in the top row.
Banks can be selected as targets for
measurement by ticking the box in front of
the specific row.
Banks can be deleted by ticking the box in
front of the specific row and going to the
local menu and selecting “DROP”.
Tapping the first (top) row will enter the
screen where manual definition of
parameters is possible.

With manual entry you can define

expected values and tolerances along with
LOT ID and expiration date.
Your changes will only be saved if you tap
the “ACCEPT” icon. You can cancel data
entry by tapping the “RESET” icon and
discarding changes by tapping the HOME
icon in the top of the screen.
QC materials (banks) once saved, cannot
be edited. If you made a mistake and
corrections must be made, please delete
the actual QC bank and enter a new bank.

Page 93 OMICON3_v34
QC diagrams
Icon-3 can represent QC data in two views.
QC data are only shown if there are actual
QC measurements stored in the analyzer’s
memory.
One view lists data in a graph where values
of parameters are displayed against
measurements in sequence (time).
You can initiate a measurement by tapping
the analyzer icon on the screen.
New QC measurements will be displayed
on the chart.

The second view displays records and the

respective parameter values on a circular
diagram. (Access it by sliding up the
screen)
You can initiate a measurement by tapping
the analyzer icon on the screen.
New QC measurements will be displayed
on the chart.
Note: The number of displayed parameter
depends on QC Parameter setting
(Short/All).

Page 94 OMICON3_v34
QC reports
Icon-3 can print Levey-Jennings diagram via
thermal and PCL5/6 printer as well. To print
diagram tap “Print” button via accessing local
menu (tap – hold screen).

Page 95 OMICON3_v34
Database functions
Browsing records
The database allows browsing records listed in rows. Swiping (scrolling) gestures
can be used to access various views of the database.
The database is arranged into three separate sets of data:
- Samples, QC measurements and Calibration data, Fast Blanks, Recycle
Bin
- Within each set, you can browse by date
- Swiping LEFT will reveal more and more detailed data of the row,
record examined
↑ ↑ ↑
Human Date Record Details
↓ ↓ ↓
↑ ↑ ↑
QC Date Record Details
↓ ↓ ↓
↑ ↑ ↑
Results Calibration Date Record Details
↓ ↓ ↓
↑ ↑ ↑
Fast Blank Date Record Details
↓ ↓ ↓
↑ ↑ ↑
Recycle Bin Date Record Details
↓ ↓ ↓

Swiping the screen in the left or right direction will switch pages displayed.
Swiping the screen up or down will scroll the view up or down: you can scroll
between dates, groups of records and individual records.
All deleted records are moved to the Recycle Bin. Records in the Bin can be
restored.

Page 96 OMICON3_v34
Database context menu
Tapping and holding any point of the
screen in database view brings up a so-
called context menu screen.
The screen has operation related
functions in the top. The central region
has icons representing functions
related to actions corresponding to
database records.

Page 97 OMICON3_v34
Selecting records
By tapping “Same Day” you can select
records measured on the day of the
actual result.
By tapping “Same SID” you can select
records matching same SampleID of
the actual result.
Tapping “Selection Start” will allow multi-selection of results. You will be taken
back to the database table view. You can select the END of the selection by
ticking the box in front of any sample. All samples between the “first” (where
selection started) and the “last” (the one you ticked) will be selected.
Select All – the feature is available if
at least one record was selected.
The number of selected records will
be shown under the list of records. By
(un)ticking the box by the “3” of 3668
will deselect ALL records.

Moving to specific date in database

After selecting date with date
picker tap “Jump” button to move
the corresponding results in
database list. Icon-3 will execute
the jump operation only if
database contains records with
the selected date.

Page 98 OMICON3_v34
Selecting records between two dates
Follow the process below to select all records between two dates:
1. Tap local menu
2. Enter start date
3. Tap “Jump”
4. Select first record
5. Tap local menu
6. Tap “Selection start” - Checkbox of first record turns red
7. Tap local menu
8. Enter end date
9. Tap “Jump”
10. Select last record – All records between start and end dates will be
selected

Search (filtered view)

You can search for any string contained in Sample ID and in Comment1-3 fields.
You can start the search only from the database category view.

Tap the menu symbol, enter your search criteria. Enter minimum 2 characters.
Search function works on normal measurement results, including those in the
Recycle Bin.
Matching results will be displayed in a separate database view.

Page 99 OMICON3_v34
Managing data
Tap the corresponding icon to
activate the function:
- print results via
connected thermal or
PCL5/6 printer
- export results in TSF format to USB HD (Tab Separated File – ideal for
external processing)
- e-mail results in PDF format
- save reports in PDF format to USB HD
- save reports in raw data format to USB HD
- send results to LIS
- drop selected records into Recycle Bin
- CV% calculates CV data of selected results.

Managing data in Recycle Bin

Tap the corresponding icon to
activate the function:
- permanent delete
selected records
- restore selected records

Sending e-mail
To email, enter the address of the
recipient. Email settings are
available under Options menu
Functionality submenu.

Keeping “CC” checkbox selected will send a copy to the default email address (as
defined under email settings).

Page 100 OMICON3_v34

LIS transmission error
If the analyzer software was unable to send results to the configured HL7 server
(network error, server error), there will be an “unsent messages” icon displayed
at the top of the screen. The number on the icon will represent the number of
unsent messages. Unsent messages will be entered in a queue.

Tapping on this symbol will display a context menu.

The user can decide to resend all unsent messages anytime. (“Send”)
The user can also decide to empty the unsent results queue. (“Cancel all”)

The attempt to reestablish communication link and resend unsent messages

depends on relevant setting. This could be 1 / 4 / 24 hours or never. If the setting
is never the software will never resend unsent messages, but the user should
clear the queue.

Page 101 OMICON3_v34

Maintenance
Cleaning the analyzer
The outer cover of Icon-3 is made of plastic, and polycarbonate. The back plate
is made of stainless steel.
The external plastic parts can be cleaned with lint free cloths soaked in light
soapy water, or alcohol-based cleaning materials, typically alcohol-based
window, or computer display cleaning solutions.
Cleaning the stainless-steel back plate should be done using alcohol-based
cleaning materials, typically alcohol-based window, or computer display cleaning
solutions.
WARNING
Never make the system aspirate liquids with alcohol content.
Alcohol will damage internal plastic components.

Daily maintenance
- Clean outer surface
- Check reagent connector
Note: The analyzer will automatically force a sampling tip wash process to avoid
the flexible tip getting jammed in the open wash head due to low usage
frequency of the open sampling tip. This event is triggered every 48hrs. The
counter restarts with every open sampling tip operation. (e.g. if the user runs
open samples every day, the system will not clean the tip; if the user does not
run open samples, then the system will wash the tip every 48hrs.)

Weekly maintenance
- Open tube sampling tip: clean the bottom of the washing head with a
cotton swab
- See also at section Cleaning procedures of the fluidic system
below

Emergency procedures
- Cleaning
- Power off

Page 102 OMICON3_v34

Reagent pack replacement
- When a reagent pack is empty (because reagent credit ran out) then a
new pack must be installed.
- The process is supported by a wizard guiding you
through the process.
- To access the wizard, tap the local menu button or the
sample vial symbol on the screen and tap on the
reagent replacement icon.
- Follow the instructions on the
screen:
o Open new pack,
locate IFU with QR
code
o Remove caps, open
vial seals
o Move reagent tubes
from old pack to new
pack
o Empty waste and tap
the icon below to
reset waste counter

o Scan QR code
o Initiate auto-prime

Replacing reagent bottles

- In case of using bulk reagents, and one of the reagent containers
becomes empty, scan the QR code of a new bottle and connect the
bottle to the analyzer.

Page 103 OMICON3_v34

Cleaning procedures of the fluidic system
The Software will regularly ask for cleaning based on its built-in timers. You will
be asked from time to time to do the following:
- Running vial filled with cleaning solution *
- Aspiration of cleaning solution through sampling tip *
- Performing a “Rinsing” action to clean apertures *
- RBC cleaning – targets RBC aperture and related tube sections *
- SV Rinse – allows flushing the ceramic valve to ensure reliable operation
(this function is included in standard operation invisible to the User, yet
this process is necessary to avoid problems).
Frequent “Noise”, “Overload” and “WBC channel dirty” problems can be reduced
or eliminated by running “Open cleaning” and “Rinsing” functions.
*= these functions have frequency based on sample count or days elapsed. The
counters can be set by Service.
A practical sequence of cleaning is as follows:
Closed Cleaning – Open Cleaning – RBC Cleaning – Rinsing
You can follow the above cleaning procedures even on a daily basis.
Some cleaning processes will ask for cleaning solution. Use Norma-iHClean
solution with the provided black cap cleaning vials to keep the analyzer on its
best performance.

Software update
You can initiate loading the analyzer with a SW upgrade by tapping the proper
button in System menu / About submenu. Contact your Service team for details.

Page 104 OMICON3_v34

Management menu
Maintenance
Maintenance menu allows running processes
related to maintaining reliable operation:
- Priming, draining reagents
- Cleaning procedures
- Diagnostic functions
- Other functions

Prime & Drain

Swiping left on the Prime line of Maintenance
opens the Prime menu, where the user can
instruct the analyzer to aspirate, prime
reagents individually if necessary.
Drain All will drain the system without the
need to disconnect reagents.
Drain Full will drain the system and reagents
must be disconnected.

Page 105 OMICON3_v34

Cleaning
It is possible to run various cleaning
actions that help keeping the system in
good working conditions.
You can clean the closed and open
sampling paths, and you can initiate a
rinsing action which is designed to
flush and prime liquids in the
measuring system.
It is also possible to run RBC cleaning
and SV Rinse.
We recommend running RBC clean
after performing Open cleaning.

Page 106 OMICON3_v34

Other
These functions are used when the
analyzer is to be out of operation for a
longer period of time.
Preparing for shipment supports
draining and cleaning all tubing paths
inside so that the analyzer can be
transported or stored for a longer
time.
Shutdown will just turn the unit of
after a thorough preparation of the
system for unpowered state.
Shutdown with Needle Clean: the
analyzer, while running, will
eventually collect some spilled blood
from sample vials. This blood does not
interfere with results, does not cause
cross-contamination of results, but it
may cause faults in the needle
cleaning procedure. Dried blood may
obstruct operation of the needle
cleaning mechanism. The needle is not
accessible to the operator.
To avoid such problems, it is strongly recommended to use a needle cleaning vial
at the end of the daily routine.
Fill an empty black cap cleaning vial or control blood vial with 2-3ml of iHClean
and close the vial. Standard sample vials may not reach the areas of the needle
that need cleaning.
When you are ready to shut down the analyzer at the end of the day, insert the
vial to the sample opening and start the Shutdown with Needle Clean process.
The analyzer will use the vial to clean and rub the needle. The vial is left over the
needle for 20 seconds so that the cleaning liquid inside will dissolve eventually
dried blood. At the end of the process the cleaning vial will be returned to its top
position and will be ready to be removed.

Page 107 OMICON3_v34

Alarm Clock symbol
When automatic maintenance and management functions are enabled in Service
Menu, Icon-3 will display a green alarm clock symbol in the top of the screen.
Tapping on this symbol will display a screen which displays scheduled events.

Note the times and dates when specific functions can be initiated by the analyzer.

Page 108 OMICON3_v34

Diagnostics
Swiping left on the Diagnostics line of
Maintenance opens the Diagnostics
menu, where the user can instruct the
analyzer to run self-testing processes,
like a Fast Blank.
Fast Blank will run an empty
measurement with reduced reagent
usage to verify the cleanliness of the
system and of system reagents.
Fast Blank results are displayed in the
lower right corner of the screen
showing WBC, RBC and PLT results. HGB
values are NOT checked in a Fast Blank
test.

The same Fast Blank process is run during

initialization of the analyzer.
Icon-3 will accept FastBlank values if the
values are below the following thresholds:
WBC < 0.2; RBC < 0.05; PLT < 40
HGB blank is automatically performed
before each measurement.

Page 109 OMICON3_v34

Service
This menu is password protected
and it is only available for and
should be used by authorized
service personnel.

Page 110 OMICON3_v34

Supervision
History
History will list all user activity in a log,
grouped into activity types. You can review
Information, User action, Errors.

History details
Swiping left on a specific line of History will
show the details of a specific message. You
can sweep up and down to access further
pages, lines.

Page 111 OMICON3_v34

About menu
The About screen will display instrument
specific information, such as:
- Product name,
- Product ID,
- Language file version,
- SW version,
- Manufacturer name and address,
- Contact to your local service
personnel (Distributor).
You can start the setting wizard.
You can initiate Remote Management (refer
to your Service Personnel).

Page 2 of About displays information about

the functional modules in the system.
Page 3 allows accessing Software upgrade
and sending or saving diagnostic files
containing information for the technical
support.
Diagnostic file is often asked by the service
personnel in case of any misbehavior.
This system diagnostic file can be saved to a
USB pen drive or stick at this screen. It will
generate *.dgst file on the USB drive. In case
of a need send this file to the local support
for analysis.

Page 112 OMICON3_v34

Database capacity
The analyzer allows managing database
capacity and helps free up space as
necessary. Running 50 samples a day will
create about 50*250 = 12500 records over
a year. The system can easily store 40.000
records, yet system speed will gradually
drop as more and more records are stored.
This page offers deleting records by their
age. To avoid final loss of records, you can
choose to export the records selected for
deleting before they are actually deleted.
You can choose PDF or TSF (Text) export.
To allow exporting before deleting, you
need to connect a USB storage device.
It is also possible to empty the Recycle Bin.

Page 113 OMICON3_v34

Status bar

1 2 3 4 5 6 7
Statusbar contains status symbols and shortcut to main menu. Instrument
statuses are including following informations (from right to left):
1. home shortcut to return into main menu / ER mode displayed
2. alarm clock – automatic scheduling is on
3. progress symbol when fluidics action is in progress (animated)
4. printer symbol when printer is connected
a. 3 versions: PCL5/PCL6, ESC/POS, Unknown)
5. wireless network symbol when wireless USB dongle is connected
6. Ethernet connector symbol when wired network cable is connected
7. Available measurement count with messages:
a. Sample count based on actual reagent level
b. Expired
c. Inactive
D, S, L indicator, when a reagent sensor is disabled in Service menu
BS indicator, when sample movement is controlled by blood sensor
External container full symbol

Page 114 OMICON3_v34

Technical Specifications

Item Description, details

WBC, LYM, MID, GRA, LYM%, MID%, GRA%
Measured
RBC, HGB, HCT, MCV, RDWsd/cv, MCH, MCHC,
parameters
PLT, MPV, PCT, PDWsd/cv, PLC-R%, PLC-C
Measurement Volumetric impedance method for WBC and RBC
technology Photometric method for HGB at 540 nm
Histograms WBC, RBC, PLT
Sampling mode Closed and Open vial mode
Aspirated sample Closed vial: 38 µl
volume Open vial: 13 µl
Processed sample
2.5 µl
volume
Throughput 60 tests / hour
Precision (CV%) WBC < 3%, RBC < 2%, PLT < 5% MCV < 1%, HGB < 2%
40,000 (max.) test results including histograms and
Storage capacity
patient data
LCD, 10.1”, 1280 × 800 with capacitive touchscreen,
User interface
portrait orientation
English, Hungarian, Italian, Spanish, German,
Romanian, French, Greek, Turkish, Russian,
Languages
Slovenian, Polish, Portuguese, Chinese (Simplified),
Vietnamese, Bulgarian, Ukrainian, Bosnian
Connectivity 2 x USB ports, Ethernet, LIS (HL7)
Dimensions (HxWxD) 280 x 216 x 320 mm
Weight 8.7 kg
External power supply, 12 VDC, 5A (100-240 VAC
Power
50-60 Hz);
Power consumption Maximum 45W

Page 115 OMICON3_v34

 Reagents Diluent, Lyse, System Solution, iHClean (optional)
Reagent use per
Diluent Lyse SysSol
measurement cycle
Open mode: 5.0 ml 1.0 ml 2.0 ml
Closed mode: 4.9 ml 1.0 ml 1.0 ml

Shipping conditions Temperature: 2-50°C (37-122°F)

Temperature: 10-40°C (50-104°F)
Storage conditions
Humidity: 20-80% relative humidity
Operating Temperature: 15-32°C (59-90°F),
Environment Humidity: 20-80% relative humidity
Instrument is designed to be operated up to
Atmospheric
2500m/8200ft above sea level
pressure
(atm. press. min: 562mmHg/75kPa)

WARNING
Only qualified service personnel may replace the internal fuse and
the time keeping battery.
When not in use or relocating, always store the analyzer in its
original packaging to avoid physical damage.
Storing the analyzer outside the above specified environmental
conditions or outside its original packaging may impair operation
and may also cause erroneous or faulty operation.
Do not place the analyzer near a direct heat source or into direct
sunlight.
The desk supporting the instrument should be flat, horizontal and
stable enough to support the weight of the analyzer and
accessories.
Operating the analyzer outside the above specified environmental
conditions may impair operation and may also cause erroneous or
faulty operation.

Page 116 OMICON3_v34

Performance Data
Precision
Precision data are listed for primary and derived parameters for n>30 below:
Parameter CV% Conditions
WBC 3.0 2.0 < WBC < 20.0
HGB 2.0 100 < HGB < 240
RBC 2.0 3.0 < RBC < 6.0
MCV 1.0 70 < MCV < 100
PLT 5.0 100 < PLT < 800
MPV 2.0 5 < MPV < 15

Accuracy
Data listed below are from a comparative study with Abbott Cell-Dyn 3700:
R2 (CLOSED Conditions
Parameter
SAMPLING) (whitepaper)
WBC 0.96 1.0 < WBC < 20.0
HGB 0.97 100 < HGB < 240
RBC 0.97 3.0 < RBC < 6.0
MCV 0.98 70 < MCV < 100
PLT 0.96 100 < PLT < 800
MPV 0.96 5 < MPV < 15

Linearity
Below linearity claims were measured using hematology linearity kits.
Parameter Linearity range Unit Notes
WBC 0 – 100 10 /µl
3

HGB 0 – 250 g/l No flagging

RBC 0 – 8.0 106/µl
PLT (LoD) = 17;
PLT 17 – 1000 103/µl
No flag below LoD;

Page 117 OMICON3_v34

Display range of parameters
Parameter Display Limit Unit Notes
WBC 0-200 10 /µl
3

LYM 0-200 103/µl (1) WBC>0.1

LYM% 0-100 % WBC>0.1
MID 0-200 103/µl (1) WBC>0.1
MID% 0-100 % WBC>0.1
GRA 0-200 103/µl (1) WBC>0.1
GRA% 0-100 % WBC>0.1
HGB 0-500 g/l
RBC 0-12 106/µl
MCV 30-180 fl RBC>0.5
PLT 0-1000 103/µl
MPV 0-50 fl PLT>10
HCT 0-80 % MCV>30
RDWsd 1-100 fl RBC>0.5
RDWcv 1-50 % RBC>0.5
PCT 0-10 % PLT>20
PDWsd 1-20 fl PLT>10
PDWcv 1-100 % PLT>10
PLCC 0-1000 103/µl
PLCR 0-100% % PLT>20
MCH 0-50 pg MCV>30
MCHC 0-500 g/l MCV>30
Values measured below or beyond the linearity (measurement) limits listed
earlier in this document will be marked with < or > symbols. E.g. PLT = 1200 will
be displayed as: “PLT >1000” accompanied by a linearity range flag.
Note (1): display precision is 1 decimal digit for diff absolute counts; diff values
will receive an asterisk (“*”) flag if 0.1 < WBC < 1.0.

Page 118 OMICON3_v34

Carry-over
High-to-low carry-over performance of Icon-3.
Parameter Carryover %
WBC <1%
RBC <1%
HGB <1%
PLT <1%

List of measured parameters

Parameter Measured Calculated Calibrated
WBC X X
LYM, MID, GRA X X*
LYM%, MID%, GRA% X
RBC X X
HGB X X
HCT X
MCV X X
MCH X
MCHC X
RDWsd/RDWcv X X
PLT X X
MPV X X
PCT X
PDWsd/PDWcv X
PLC-R% X
PLC-C X X**
*calibrated by WBC factor
**calibrated by PLT factor

Page 119 OMICON3_v34

Known Limitations, interfering substances
Low PLT performance
Samples with extremely low PLT and (occasionally) elevated RBC counts may
report falsely elevated PLT count due to some RBC being falsely identified as PLT.
The possible interference can be detected if the RBC curve seems to reach into
the PLT region, especially with high (near upper limit of normal value) RBC
counts. In such cases, a manual smear should be used to verify the results.

PLT clumps
Some samples may contain PLTs that tend to form clumps and thus may be
reporting low PLT values in an otherwise normal sample. This may be caused by
the type of anti-coagulant or due to some medication that makes PLTs more
likely to form clumps. Incorrect sample collection or failure to follow mixing
immediately after taking the sample may also cause PLT clumps. If such condition
was assumed, make sure to mix the sample thoroughly before running it in the
analyzer again.
If clumps are suspected due to low PLT value, elevated MPV, indefinite valley
between RBC and PLT populations or pseudo populations present beyond the
RBC peak, then microscopic inspection of the sample is recommended. Please
note that accurate PLT counts cannot be achieved if clumps were present.

HGB interference
Determination of the HGB value in a sample is based on a photometric
measurement based on absorption of light of 540 nm wavelength through the
lysed blood sample. HGB is related to the amount of light detected by the
photometer. Any substance that may reflect or diffract light can have effect over
the amount of light detected by the photometer by changing the amount of light
detected. Lysis destroys RBC and leaves WBC and PLT in the solution. WBCs are
much less in number so that they would not influence the amount of light
detected by the photometer.
Particles (e.g. WBC) present in excess number will however act as tiny mirrors
suspended in the liquid (sample) and can influence the amount of light detected.
The analyzer is equipped with the necessary compensation algorithms to reliably
provide HGB values unaffected by WBC count.

Page 120 OMICON3_v34

Some factors that cannot be detected by the device and thus accounted for may
also interfere with the optical determination of HGB: lipemic samples where lipid
particles can interfere with light intensity detection; samples with e.g. high
bilirubin content may also have an incorrect HGB value determined due to the
possible color interaction.

Anti-coagulant used
The anti-coagulant used for treating the sample has one of the most influencing
effects over results. The right chemical, the correct amount and proper
homogenization are all key factors to a reliable result. Using a lower amount of
anti-coagulant may leave the sample partially clogged, resulting in PLT clumps;
extensive amounts will dilute the sample, and can boost cell aging and
degradation, some RBC may turn into burr-cells making MCV reading inaccurate.
PLT clumps, coagulation, unstable, varying cell counts may also be the side
effects. Not using anti-coagulant or using an improper sample collection vial may
result in radical fluctuation of parameter values.

Sample age
Sample age also has a significant effect on results. Samples should be analyzed
within 6 hours from sample collection. If samples cannot be analyzed within this
time frame, then they should be stored refrigerated (2-8°C). Samples analyzed
beyond 24 hours may suffer decrease in WBC and RBC counts, HCT value. HGB
usually remains stable, yet PLT value may increase as a consequence of degrading
blood cells.

Nucleated RBC (nRBC)

The name nRBC stands for nucleated RBC that are rarely present in blood
samples taken from healthy patients. These cells are unmatured RBC’s and are
found in the blood stream if there are some anomalies present in the process of
blood production. Having a nucleus, these cells will still be detected after lysis –
the nucleus may even remain in the size range of WBC. They may interfere with
LYM counts by representing an additional population below or around the cell
size of lymphocytes.

Page 121 OMICON3_v34

Electrical block diagram
Icon-3 is powered by an external power supply (input voltage range: 96-243VAC
@ 47-64Hz output: 12 VDC, 5A).
Internal fuse: 3.5A at Power Input (SOURCE board).
WARNING
Only qualified service personnel may replace the internal fuse
or the time keeping battery.

(External)
Power Supply
USB, SOURCE
ETHERNET (power)

MOTORx2
FCTRL I
VALVESx6
LILIOM
MOTORx2
COLIBRI FCTRL II VALVESx3
PUMP
DCENT DATA DHGB

DISPLAY PROCESSING
& CONTROL REAGSENS

TOUCH HIGH
AMPLIFIER
VOLTAGE
TOUCH CTRL

The main controlling board (Liliom) hosts a computer module (Colibri) which is
connected to the LCD and the touch screen, and to the USB/Ethernet ports.
Motors, pumps and valves are controlled by 2 special boards (FCTRL I & II).
The impedance measurement signals are processed by the amplifier, and the
DCENT board. DHGB board measures HGB.
SOURCE board receives and distributes power and displays analyzer status lights.
It is also connected to the START button board.

Page 122 OMICON3_v34

Fluidic diagram
Icon-3 contains the following key fluidic components:

- Electronic boards (main board, signal processing boards, controller

boards for moving components, display)
- 9 valves (A,B,D,H,I,N,R,S,W)
- A shear valve with sampling sections: S1-3, D4-5, C6
- Motors (syringe movement, ceramic valve movement, pump, sample
rotor/sample unit),
- Measuring assembly incorporating ruby apertures (100µm/70µm)
- Peristaltic pump (“PUMP”)
- Sample sensors (Open, Closed), reagent sensors: (Dil, Lyse, SysSol)

There are no user serviceable components inside the analyzer.

Do not attempt to open the external covers to avoid damage to

the system and avoid mechanical injury and can invalidate
warranty.

Page 123 OMICON3_v34

Reagent consumption
All values are in ml (milliliter). Values indicate worst case aspirated volumes.

Process iDil3 iLyse3 iSol3

Start-up (initial + wake up) 15.0 3.0 5.0
Start-up + FAST blank (typical
6.2 1.0 2.5
consumption)
Measure FAST blank 3.0 0.5 0.0
Measure CLOSED sample 4.9 1.0 1.0
Measure OPEN sample 5.0 1.0 2.0
Switch to OPEN mode (from CLOSED
0.0 0.0 1.0
mode)
Switch to CLOSED mode (from OPEN
0.0 0.0 1.0
Mode)
Closed Cleaning 3.0 0.0 0.0
Open Cleaning 13.0 1.0 3.0
RBC Cleaning 13.0 1.0 3.0
Rinsing (aperture prime) 3.0 0.0 1.0
System Solution cleaning 6.0 1.0 3.0
Shear valve rinse 0.0 0.0 2.0
Prime iDil 1.0 0.0 0.0
Prime iLyse 0.0 1.0 0.0
Prime iSol 0.0 0.0 3.0
Shut-down 2.0 0.0 2.0

Page 124 OMICON3_v34

Error messages
The software can report various errors in connection with results and operation.
Error messages are displayed in a small pop-up bubble in the lower right corner
of the screen. Errors have technical details which are useful when contacting
Technical Support.
Technical Support will ask for diagnostic files to facilitate problem resolution.
Either have the analyzer connected to the Internet or have a USB storage device
ready (formatted for FAT32 file system) for saving and emailing data.

Mechanical Errors
Error message Reason for error Remedy
Shear Valve error. An Mechanical Error Rerun operation. If
error occurred while persists, contact Service.
testing Shear Valve
backlash.
An error occurred while Pump not operating, Rerun operation. If
attempting to use pump. pump jammed. persists, contact Service.
Sampling Rotor error. An Mechanical error. Rerun operation. If
error occurred while persists, contact Service.
attempting to use Check whether closed
Sampling Rotor. mode sampling opening is
obstructed.
Sampling Rotor error. An Mechanical error, sensor Rerun operation. If
error occurred while induced. Flexible tip might persists, contact Service.
attempting to use have been obstructed Verify that tip can move
Sampling Rotor (Sampling moving in/out. freely.
Rotor invalid position).
Valve error. An error Valve controller Error Rerun operation. If
occurred while attempting persists, contact Service.
to set valve.
Shear valve recovery The shear valve had Confirm, and run
problems moving, but the initialization.
system resolved the error If possible, go to
Management /
Maintenance / Cleaning /
Shear valve rinse

Page 125 OMICON3_v34

Operation related errors
Error message Reason for error Remedy
Communication error. An No Internet access Consult network
error occurred while administrator.
sending an e-mail
(connection exception).
Control assay sheet You scanned a sheet that N/A
already exists. has been scanned
previously.
Communication error. An Network error. Consult network
error occurred while administrator.
attempting to download
software upgrade file
(unspecified error).
Communication error. An HL7 server did not reply Check cable connection;
error occurred while for a message. verify HL7 settings;
attempting to connect to verify HL7 server status.
HL7 server (IP address?
Port? Is the server
running? Firewall?)
Network error. An error There is no activity on the Check cable connection,
occurred while attempting network. check network status.
to connect of HL7 server Verify IP (address) settings
(Network cable is
unconnected?).
Measurement error General measurement Contact service with error
error. details.
QC LOT field cannot be You did not enter a LOT Enter a LOT ID.
empty. ID.
QC with defined LOT Verify LOT ID
already exists.
An error occurred while QR code faulty. Try scanning the sheet
decoding QR code (invalid again. If you fail, load data
or broken QC code). from a file. Contact tech
support for details.
Reagent detection error. Bubbles detected by Check that reagent
An error occurred while sensor. container is not empty.
attempting to calibrate
reagent sensor at Diluent
inlet.

Page 126 OMICON3_v34

 Error message Reason for error Remedy
Reagent detection error. Bubbles detected by Check that reagent
An error occurred while sensor. container is not empty.
attempting to calibrate
reagent sensor at Lyse
inlet.
Reagent detection error. Bubbles detected by Check that reagent
An error occurred while sensor. container is not empty.
attempting to calibrate
reagent sensor at System
Solution inlet.
Tube Detector warning Incorrect vial inserted in Insert a correct tube.
(missing condition). sample rotor.
Tube Detector warning No vial detected. Insert a tube, check for
(insert tube). compatibility.
Tube Detector warning A vial is detected in Remove sampling vial.
(remove tube). sample rotor, yet selected
action requires the vial to
be removed
Sampling Tip warning Sampling tip could not be Check for obstruction.
(active open mode). moved. Run “Eject” from local
menu.
Sampling Tip warning Sampling tip could not be Check for obstruction.
(inactive open mode). moved. Run “Eject” from local
menu.
User error A vial got blocked, or was Check for obstruction.
incorrectly inserted Run “Eject” from local
menu.
An error occurred while Incorrect email data Verify settings, contact
sending an e-mail specified, or unsupported network administrator.
(username or password email client was set up. Observe and follow
exception). network and email setting
instructions.
Sample aspiration error. The system registered a Service can check and
Please rerun the sample. possible blocked clean the relevant tubing
If the error persists, aspiration path (needle, or sections.
contact service flexible tip).

Page 127 OMICON3_v34

 Error message Reason for error Remedy
Closed Wash Head The waste liquid Service needs to clean the
maintenance required. To aspiration inside the closed sampling module.
prevent damage to the system failed. To prevent Contact Service.
system, closed further damage to the
measurement mode is system, closed mode
disabled. Open mode is operation is disabled.
still available. Please Open mode remains
contact service. operable.
Closed Washing Head There is a mechanic jam Eject vial (if there was one
error. An error occurred inside the analyzer. To inside when the error was
while closing Washing prevent damage to the displayed) and contact
Head at Shear Valve. system, the analyzer service. The unit cannot
Contact Service without disables closed sampling be used until the failure is
executing any process mode. resolved.
except Eject Vial.

Electronic errors
Error message Reason for error Remedy
Camera error. An error The camera could not be Power off and on again. If
occurred while activating detected. the problem persists, use
camera. electronic files to load
data.
Contact service to
schedule a visit.

System (software) errors

Error message Reason for error Remedy
Database error. An error Software error, corrupted The system will try to
occurred while attempting file system. recover the error. If the
to read/write database. error persists, contact
Tech Support.
Database error. An error Software error, corrupted The system will try to
occurred while attempting file system. recover the error. If the
to create record in error persists, contact
database. Tech Support.

Page 128 OMICON3_v34

 Error message Reason for error Remedy
Communication error. An A key system element is Contact Tech Support.
error occurred while missing.
attempting to read/write
ProductID.
Fluidics error. An A key system element is Contact Tech support for
unknown low-level error missing or is guidance.
occurred while attempting malfunctioning.
to execute fluidics
function.
Fluidics error. An A key system element is Contact Tech support for
unknown error occurred missing or is guidance.
while attempting to malfunctioning.
execute fluidics function.
Fluidics error. An A key system element is Contact Tech support for
unknown error occurred missing or is guidance.
while attempting to malfunctioning.
get/set arguments of
fluidics subsystem.
Processing error. An error A key system element is Contact Tech support for
occurred while attempting missing or is guidance.
to process raw malfunctioning.
measurement data.
System error. An error A key system element is Contact Tech support for
occurred while attempting missing or is guidance.
to query active QC LOT. malfunctioning.
Communication error. An A key system element is Contact Tech support for
error occurred while missing or is guidance.
attempting to open serial malfunctioning.
port.
System error. An error A key system element is Contact Tech support for
occurred while attempting missing or is guidance.
to play sound file. malfunctioning.
Communication error. An The printer is not Connect the printer.
error occurred while connected. Contact Tech support for
attempting to print with A key system element is guidance.
thermal printer. missing or is
malfunctioning.

Page 129 OMICON3_v34

 Error message Reason for error Remedy
Reagent detection error. A key system element is Contact Tech support for
An error occurred while missing or is guidance.
attempting to detect malfunctioning.
Diluent.
Exporting error. An error No USB storage device Connect USB storage
occurred while attempting attached. device
to export Tab Separated A key system element is Contact Tech support for
File. missing or is guidance.
malfunctioning.
Communication error. An A key system element is Contact Tech support for
error occurred while missing or is guidance.
attempting to send e-mail malfunctioning.
(unspecified error).
An error occurred while A key system element is Contact Tech support for
attempting to set volume. missing or is guidance.
malfunctioning.
Software error A key system element is Contact Tech support for
missing or is guidance.
malfunctioning.
System error A key system element is Contact Tech support for
missing or is guidance.
malfunctioning.
System error. An error A key system element is Contact Tech support for
occurred while attempting missing or is guidance.
to initiate system malfunctioning.
(unspecified error).
Reagent detection error. A key system element is Contact Tech support for
An error occurred while missing or is guidance.
attempting to detect Lyse. malfunctioning.
Reagent detection error. A key system element is Contact Tech support for
An error occurred while missing or is guidance.
attempting to detect malfunctioning.
System Solution.
Reagent system error. An A key system element is Contact Tech support for
error occurred while missing or is guidance.
attempting to activate malfunctioning.
reagent (expired).

Page 130 OMICON3_v34

 Error message Reason for error Remedy
System error. An error A key system element is Contact Tech support for
occurred while attempting missing or is guidance.
to modify reagent’s malfunctioning.
tracking level.
System error. An error A key system element is Contact Tech support for
occurred while attempting missing or is guidance.
to query active reagents malfunctioning.
(inactive or expired
reagents).
Reagent detection error. A key system element is Contact Tech support for
An error occurred while missing or is guidance.
attempting to read malfunctioning.
reagent sensor data.
Firmware Error A key system element is Contact Tech support for
missing or is guidance.
malfunctioning.
Remote Management IP address of Access Contact Service for proper
error Server is incorrect, or a setup
Firewall blocks connection
Icon-3 recovered after A software error forced No action required.
internal error. You can the system to reinitialize Continue work. The
continue your work. the User Interface restart process will turn
the screen off and
standard startup
sequence is visible.
Database verified and A database error was No action required.
fixed. found at startup, and the
software could
successfully fix the
problem.

Page 131 OMICON3_v34

Troubleshooting
Measurement problems
Symptom Possible cause Remedy
High BLANK values Contaminated Replace reagents
reagents
Cold reagents Make sure reagents reached room
temperature
Unearthed power Connect power supply to grounded
outlet power outlet or connect ground to
Minor internal chassis of analyzer
contamination Repeat FastBlank 3-4 times
Missing reagents, One reagent is out Replace reagents
wrong results Reagents are not Verify reagent connector
connected Replace reagent pack, or replace
Reagent connector connector
sealing failure Prime reagents. Look for bubbles in the
tubes outside the analyzer
Incorrect WBC Lysing reagent Check reagent connector, prime Lyse
differentiation errors reagent 2-3 times.
Low sample Too low blood Run vials with correct sample volume
volume reported sample volume Make sure you run open sampling
Open mode correctly: remove vial only after Icon-3
signals to.

Closed mode Check minimum sample volume (300µl).

Run closed cleaning.
If the problem persists, contact Service
Leakage from rear Reagent connector Replace reagents
reagent connector sealing failure Verify reagent connector
Replace reagent pack, or replace
connector
Noise flags Bubbles are Run Rinsing 2-3 times
trapped inside (Management/Maintenance/Cleaning.
critical tubes.
Lysing flags Reagent Prime DIL and LYSE
(improper lysing) insufficiency If the problem persists, contact Service.

Page 132 OMICON3_v34

 Symptom Possible cause Remedy
Improper voltage Reagent Prime DIL and LYSE
insufficiency, or Run Rinsing, Open Cleaning functions
block inside the
If the problem persists, contact Service.
analyzer
Unstable voltage Reagent or sample Run Rinsing and Open cleaning.
insufficient. Partial Run RBC cleaning (if RBC/PLT values are
clogging of the affected)
system

Inform Service
Dirty WBC channel Electrodes “dirty”: Run Open cleaning
error buildup due to high
sample load

Electrical problems
Symptom Possible cause Remedy
Instrument cannot be Power is not connected Connect power source,
powered on Power voltage is too high, verify connections
or too low Replace / check power
Fuse is blown inside supply (is LED on?)
analyzer Contact Service
Indicator on top/front of Power voltage is too Replace power supply
the analyzer glows in RED high/low
or BLUE color BEFORE
power ON
Instrument powers down Power system fluctuations Try to start the analyzer
during operation again. Use a UPS.
Contact Service
Software error message Corrupted SW system. Contact Service
Touch screen does not Faulty touch screen Connect an external
react to gestures mouse for temporary
operation. Contact Service
Uncertain operation of Faulty touch screen Connect an external
touch screen mouse for temporary
operation. Contact Service

Page 133 OMICON3_v34

Mechanical problems
Symptom Possible cause Remedy
Sample vial is stuck in Power outage during Start analyzer again,
sample rotor operation initiate measurement
sequence
Oversized vial, vial stuck Go to local menu (HOLD
any point on the screen)
and initiate “Eject”
Mechanical error. Contact
Mechanical Problem Service

Sample vial is not Cap detector failure. Contact Service

lowered, system reports Use OPEN mode as
missing tube, yet tube and workaround
cap are present
Sample vial is not Vial is stuck on sampling Start analyzer again,
returned to operator needle initiate measurement
sequence.
Go to local menu (HOLD
any point on the screen)
and initiate “Eject”
Mechanical error (strong
Contact Service
noise)
Grinding noise from inside Mechanical blocking Try to rerun the
of analyzer operation.
If the problem persist,
then contact Service
Analyzer reports empty Too low blood sample Run vials with correct
measurements volume sample volume
Rerun sample.
Clogged sampling paths Contact Service
Leakage beneath analyzer Blocked sampling Try running system
valve/needle system cleaning.
If it still fails, contact
Service
Leaking reagent Check reagent connector
connector

Page 134 OMICON3_v34

Hydraulic problems
Symptom Possible cause Remedy
Instrument reports Bad quality sample used Try to initiate a
clogging measurement. Built in
functions will attempt to
unclog needle and
apertures.
Run system cleaning
(Open Cleaning).
If the problem persists,
contact Service

Flexible sampling tube is Tube has been pushed in Try to restart analyzer.
not pushed out during by user, or movement is
open tube sampling blocked.
Tube was bent/broken by
Contact Service
user, tube cannot be
pushed out
Leakage from the wash Clogging in washing head, Clean washing head.
head of the open tube salt crystals. Check external reagent
sampling Pump failure. tubes.
Kinked external waste If it still fails, contact
tube. Service

Page 135 OMICON3_v34

Network problems
Symptom Possible cause Remedy
Network error message at HL7 or email Verify HL7 / email
the end of every sample communication is enabled settings. Disable email
(forced) but (clear account data) or
settings/network does not clear HL7 settings
comply.
Remote Management Remote Management Contact Service for
error message data are incorrect correct settings
WIFI dongle not Driver error Check supported list of
recognized WIFI chipsets

Printer problems
Symptom Possible cause Remedy
Scrambled printout Incorrect printer model Use Printers with PLC5 or
ESC/POS language support
Empty pages printed Incorrect printer model Install compatible printer.
Contact Service for
instructions
Printer connected, but no Printer is not supported, Test the printer and USB
printer icon in top row of USP cable wrong cable with a PC.
Icon-3 screen Printer is OFF
Restart Icon-3.
Make sure to use the
same grounded electrical
outlet for Icon-3 and
peripherals.
Test USB sockets with an
external Keyboard or with
a USB stick (and try to
save diagnostic files to the
USB)

Page 136 OMICON3_v34

Directives and Standards
Icon-3 complies with the following directives and standards as listed below.
Directives
1. 98/79/EC on in vitro diagnostic medical devices (IVD)
2. 2011/65/EU on restriction of hazardous substances (ROHS)
3. 2014/30/EC on electromagnetic compatibility (EMC)
4. 2014/35/EC on low voltage (LVD)
on waste electrical and electronic equipment
5. 2012/19/EU WEEE
(WEEE)
Standards
Medical devices – Quality management systems
1. EN ISO 13485:2016
– Requirements for regulatory purposes
Performance evaluation of in vitro diagnostic
2. EN 13612:2002
medical devices
Medical devices – Application of risk
3. EN ISO 14971:2012
management to medical devices
Medical devices – Symbols to be used with
4. EN ISO 15223-1:2016 medical device labels, labelling and information
to be supplied – Part 1: General requirements
In vitro diagnostic medical devices – Information
5. EN ISO 18113-1:2011 supplied by the manufacturer (labelling) – Part 1:
Terms, definitions and general requirements
In vitro diagnostic medical devices – Information
supplied by the manufacturer (labelling) – Part 3:
6. EN ISO 18113-3:2011
In vitro diagnostic instruments for professional
use
Safety requirements for electrical equipment for
measurement, control, and laboratory use – Part
7. EN 61010-2-101:2002
2-101: Particular requirements for in vitro
diagnostic (IVD) medical equipment
Electrical equipment for measurement, control
and laboratory use – EMC requirements – Part 2-
8. EN 61326-2-6:2006
6: Particular requirements – In vitro diagnostic
(IVD) medical equipment
Medical device software – Software life-cycle
9. EN 62304:2006
processes

Page 137 OMICON3_v34

Declaration of Conformity

Manufacturer’s name: Norma Instruments Zrt.

Headquarters: Papírgyár u. 58-59., 1038 Budapest, Hungary
Business premise: Arany János u. 11-13., 3530 Miskolc,
Hungary

We, Norma Instruments Zrt., do herewith declare under our sole responsibility
that the CE marked In Vitro Diagnostic Medical Device

Norma Icon-3 Automated 3-part Hematology Analyzer

is in conformity with the Essential Requirements of Annex I and with the

requirements listed in Annex III by the Directive 98/79/EC on in vitro diagnostic
medical devices (IVD Directive),
and is in conformity with the requirements of the harmonized quality
management system of EN ISO 13485:2016.

Errata
This manual is under continuous revision and improvement. The sections listed
below are known to describe functions focusing on convenience of use that
may not yet be available in your analyzer.
Missing descriptions or functions do not impair the operation of the analyzer.
References:
- 98/79 EN Directive
- pubmed.org
- eurlex.eu

Page 138 OMICON3_v34

Revision history
Version Release Change Sections Date Edited by
Affected
1.1N V10 Original version All 2013-11-25 CsMagyar
1.1O Electronic block diagram updated p42 2013-11-29 CsMagyar
1.1P Battery type changed, power consumption added, only P41 2013-12-04 CsMagyar
service may replace internal battery. P42
Fuse rating changed, Electrical Block Diagram updated, Only P43
Service may replace the internal fuse.
Tubing system drawing updated, 79 valves
1.2A V11 Reagent bottle cap assembly P15 2014-03-06 CsMagyar
1.2B Menu system (basic tree) applied Mar10 state 2014-03-11 CsMagyar
Barcode scanner, onscreen kb
Database screen layouts (relative)
1.2c Screenshot updates start All 2014-03-25 CsMagyar
Todo resolution, troubleshooting added
1.2gb Proof take1 All 2014-04-24 CsMagyar
1.2gc Reagent connector drawing review P16 2014-04-25 CsMagyar
1.2gd Consumption (diluent) corrected P46 2014-04-27 CsMagyar
1.2h Error messages added P49 2014-04-07 CsMagyar
1.2h2 Email setup P29 2014-05-08 CsMagyar
1.2j1 Updated profiles; measurement screen (profiles are visible); 2014-05-15 CsMagyar
reagent consumption updated; qc lj and radar chart
1.2j2 V12 Added warning about limited lifetime of closed vial caps P12 2014-08-19 CsMagyar
1.2j3 Added mode-to-mode calibration; P39 2014-08-27 CsMagyar
Screenshots, descriptions updated (SW version 0.1.348.0) P21
1.2j4 Intended Use added P8 2014-09-18 CsMagyar
Standby states revised, power modes and power off revised P17-18
Reagent open stability updated P18
Specifications revised P51
Reagent tubes can be made shorter upon installation P16
Troubleshooting revision P56-
1.2j5 Added interpretation of histograms P10 2014-10-09 CsMagyar
Custom wallpaper option P27
New icons: Load wallpaper, Save RAW data P25
AutoPrint option P28
Network setup: gateway option available P32
“WBC channel dirty” resolution clarified (Technical flags) P37
Thermal printer printout updated P38
Results (Database) context menu screenshot updated P45
Reag bottle replacement, remote SW upgrade removed in P46
this manual revision. P46
Cleaning frequency, P53
Hydraulic diagram updated (sensors, etc.)
1.2j6 V13 Added description of correct sample vial position in open P35 2015.01.06 CsMagyar
mode
1.3a Icons update P24-25 2015.02.20 Jcsikós,
Printout settings: signature option, technical data P28 Atremmel
Customization, Profiles and LIS settings P29 CsMagyar
Reagents information: open bottle stability and usage P30
statistics P36
Quick result parameter’s number P38-39
Result printout formats P40-41
ER mode introduced P42
Mode-to-mode calibration: calibrate function P46
QC report printout formats P47
Fast Blank type is available in Results (Database) P48
Selection mode by SampleID P49
Jump to date function P50
Open cleaning request based on measurement count P54
Statusbar information
Necessary screenshot changes P13
Place reagents on the same level as Icon

Page 139 OMICON3_v34

 Version Release Change Sections Date Edited by
Affected
1.3b Performance details added (new page) P56 2015.02.24. CsMagyar
1.3b2 V14 1.3a changes confirmed ALL 2015.03.11. CsMagyar
1.3b4 ER maintenance pictures and description P40 2015.06.15. Atremmel
LIS settings changed P29
1.3b5 Added FastBlank limits P53 2015.07.01. CsMagyar
1.3b6 Repaginated to A5 format (use page#x2 for older ref) ALL 2015.07.20. CsMagyar
Added: About/remote management access P43, P86
Added: top/front LEDs indicate power supply failure P100
1.3b7 SW version update FP 2015.08.17 CsMagyar
Printer support (languages) description added P60
Cleaning procedures (RBC, SV) added to std process P79
RBC clean and SV rinse added (+screenshot) P81
Troubleshooting updated P99-104
1.3b8 V15 3part population interpretation amended (more details) P7 2015-9-24 CsMagyar
1.3b9 Menu tree revised P27 2015-12-08 CsMagyar
Used icons updated P35
Printout settings revised P41
Settings/Customization: external reagent container volume P42
ER mode details P62
Calibration text review P65
Status bar updated P87
Troubleshooting review (SV block and SV recovery added) P94-99
1.3b10 V16 Correction of nr. of parameters P2 2015.12.11 CsMagyar
1.3b11 V17 SW version, manual revision and date changed FP 2016.02.03 CsMagyar
FB does not measure HGB P83
HGB vs. FB clarification (FB removed from explanation (see P57
above)) P10
HGB blank measured in every sample
1.3.3 V18 SW version, release date FP 2016.03.22 CsMagyar
Warranty section excludes duration P5 …
ER mode settings can be changed in Service P64 2016.03.31
Cleaning process clarifications P80
FB screenshot updated P83
HGB blank measured in every sample
Reagent consumption updated, Revised formatting (all) P93
1.3.31 V19 Added warm-reset message – 0.3.712.0 P99 2016.04.19. CsMagyar
Added details to Cleaning (sequence, even daily P80,82
application)
1.3.322 V20 Error messages added PP96-97 2016.05.04. CsMagyar
1.3.323 V21 Warranty: SW modification exclusion added P5 2016.05.27 CsMagyar
Unsent messages (LIS) and related Icons, screens P79*
HL7 and network related error messages P96
1.3.324 V22 Added open mode sensor disabling option description and P44* 2016.06.01 CsMagyar
screenshot
1.3.325 V23 POC application added to Intended Use 2016.06.16 CsMagyar
1.3.326 V24 Operator’s manual removed from accessory list 2016.09.23 CsMagyar
FastBlank limits description reviewed P85 2016.11.21
1.3.327 V25 Warranty section: list of excluded parts added P5 2017.01.13. CsMagyar
1.3.330 V26 Wash head – SV protection messages P98 2017.02.15 CsMagyar
WBC diff display precision 1 decimal digit P92
1.3.331 V27 PLCC, PLCR are available on the limits page P42 2017.03.09 CsMagyar
1.34 V28 Min. sample volumes, pierceable cap and related things p11 2017.10.16 CsMagyar
External power supply version changed

Page 140 OMICON3_v34

 Version Change Sections Edited Revised
Affected date by date by
v29 Main menu  1-tap operation 271117 CSM 220118 AT
1.35 List of supported Wi-Fi dongles, images of p17-18 220118 AT
optional accessories updated
Email “sender address”  default CC address p41 220118 AT
Printout formats added p43 220118 AT
PDF file name includes SID p62 220118 AT
FlexTip cleaning in every 48hrs (max) p84 220118 AT
Linearity ranges (PLT) corrected p94 220118 AT
Diff values 0.1—1.0, diff values receive * mark p95 230118 BM
Known Limitations added p96-98 230118 BM
Database autofix error message added p108 220118 AT
Revision section extended rev 150118 CSM 230118 BM
V30 Technical specifications corrected
1.36 Measurement technology p4
The measurement process p9
2019.01.17 TD 2019.01.17 CSM
Technical Specifications p93
Performance Data p95
Reagent consumption p102
V31 Updating SW pictures all
1.37 2019.03.11 RM 2019.03.14 CSJ
Tech. flags WBC & 3part fallback implemented p61
V32 Updated SW pictures all 2020.08.06 TA, 2020.08.14 GYA
Sampling modes in menu tree; Page name of RM,
p37 TD
System settings and About in menu tree
External keyboard information p40
Hint function description removed p42
Active Wi-Fi icon added; printer icon description
p42
and TSF function updated
Setting wizard short description added p45
Report output and date/time updated p46
Email settings updated; SMTP settings added;
p49
Network preferences added
Printout settings updated p51
Printout format updated p52
Network printing added p54
QC measurement warning setting added;
p55
Interpretation flagging setting added
Profiles page index updated p56
LIS page index updated, resend option added p57
Manual QR code entry added p63
List of Technical Flags revised p74
Interpretative flags added p77
PCL6 option added p80
Shutdown with Needle Clean added p81
ER mode settings updated p84
QC measurement warning added p91
Recycle Bin added p96
Select all added p98
Search (filtered view) added p99
Managing data in Recycle Bin added p100
LIS transmission error (resend option) updated p101
Shutdown with Needle Clean added p107
Database capacity added p113
PCL6 and Blood Sensor indicator added p114

ASTM option removed p115

Page 141 OMICON3_v34

 Black cap cleaning vials added as a new p21, 22,
v33 2020.10.02 TD 051020 MCS
accessory 106, 104
p36, p38,
p57, p79,
v34 Picture replacement 2020.11.27 TA 2020.11.27 TD
p80, p94,
p95

Page 142 OMICON3_v34