Service Manual

Norma Icon

Automated 3-part Hematology analyzer

NORMA Diagnostika GmbH

Hauptstrasse 7., Untertullnerbach, 3011, Austria
[email protected]

Issue date: 2015-MAR-23

Version: 1.2A7
page 2 / 106
Contents
Introduction................................................................................................................................................... 7
Who should read this manual ................................................................................................................... 7
Symbols used in the manual...................................................................................................................... 7
Disclaimer .................................................................................................................................................. 7
Symbols on the outside of the analyzer .................................................................................................... 8
Technical contact....................................................................................................................................... 8
Warranty ................................................................................................................................................... 8
Measurement technology ............................................................................................................................. 9
Impedance based cell counting ................................................................................................................. 9
Hematology parameters.......................................................................................................................... 10
3-part differentiation of White Blood Cells ......................................................................................... 10
The measurement process ...................................................................................................................... 10
Supported blood collection tubes ........................................................................................................... 11
Technical Specifications............................................................................................................................... 12
Description of the analyzer ..................................................................................................................... 13
Identifying parts of the analyzer ............................................................................................................. 14
Electronic components ............................................................................................................................ 15
Mechanical components ......................................................................................................................... 24
Hydraulic components ............................................................................................................................ 28
Electrical block diagram........................................................................................................................... 30
Fluidic system .......................................................................................................................................... 31
Reagent consumption ............................................................................................................................. 32
Reagent system ........................................................................................................................................... 33
Reagent pack ........................................................................................................................................... 33
Reagent bottles ....................................................................................................................................... 33
How does it work? ................................................................................................................................... 34
The measurement process .......................................................................................................................... 36
Installation ................................................................................................................................................... 43
User serviceable parts ............................................................................................................................. 43
Connecting peripheral devices ................................................................................................................ 44
Keyboard (optional) ............................................................................................................................. 44

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 Mouse (optional) ................................................................................................................................. 44
Bar code scanner (optional) ................................................................................................................ 44
USB flash drive (optional) .................................................................................................................... 44
USB Wi-Fi Dongle (optional) ................................................................................................................ 44
USB flash drive (optional) .................................................................................................................... 44
Service menu ............................................................................................................................................... 45
Service menu tree ................................................................................................................................... 45
Product ID screen ................................................................................................................................ 46
Sensors ................................................................................................................................................ 46
Stress ................................................................................................................................................... 47
Amplifier test ....................................................................................................................................... 47
Fluidic system ...................................................................................................................................... 48
Sample Rotor ....................................................................................................................................... 49
Service Activity #3 ............................................................................................................................... 50
Service settings .................................................................................................................................... 50
Maintenance ............................................................................................................................................... 52
User maintenance ................................................................................................................................... 52
Preventive maintenance ......................................................................................................................... 53
Service visit .............................................................................................................................................. 53
Software upgrade .................................................................................................................................... 54
Troubleshooting .......................................................................................................................................... 56
Error messages ........................................................................................................................................ 56
Technical Details of an error message ................................................................................................ 61
Collecting Diagnostic Information ........................................................................................................... 62
Diagnostic File...................................................................................................................................... 62
TSF files ................................................................................................................................................ 62
Raw measurement data ...................................................................................................................... 63
Technical flags (results) ........................................................................................................................... 64
Atypical 3part ...................................................................................................................................... 64
Distortion ............................................................................................................................................. 64
Improper Voltage ................................................................................................................................ 64
Inadequate Lysis .................................................................................................................................. 65

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 Noise .................................................................................................................................................... 65
Low sample volume ............................................................................................................................. 65
Overload (X) ......................................................................................................................................... 66
Range Exceeded .................................................................................................................................. 66
Unstable HGB ...................................................................................................................................... 66
Unstable HGB Baseline ........................................................................................................................ 66
Unstable Voltage ................................................................................................................................ 66
WBC Channel Dirty .............................................................................................................................. 66
Electrical problems .................................................................................................................................. 67
Mechanical problems .............................................................................................................................. 68
Hydraulic problems ................................................................................................................................. 69
Measurement problems .......................................................................................................................... 70
Entering QC target values manually ........................................................................................................ 71
Accessories .................................................................................................................................................. 73
Service ......................................................................................................................................................... 74
Outer Cover ............................................................................................................................................. 75
Electronic boards ..................................................................................................................................... 76
Mechanical modules ............................................................................................................................... 78
MAIN INJECTOR ................................................................................................................................... 78
Sample mixer and flexible sampling tip............................................................................................... 79
Disassembly procedures.............................................................................................................................. 80
Outer cover.............................................................................................................................................. 80
Electronic boards ..................................................................................................................................... 83
HVDCDC ............................................................................................................................................... 84
Amplifier .............................................................................................................................................. 84
FCTRL board(s) replacement ............................................................................................................... 85
Mechanical units ..................................................................................................................................... 87
Main Injector ....................................................................................................................................... 87
Mini Injector ........................................................................................................................................ 91
Sampling valve ..................................................................................................................................... 92
Sample mixer ....................................................................................................................................... 94
Measuring block ...................................................................................................................................... 97

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 Aperture probe voltage troubleshooting ............................................................................................ 97
Tubes ..................................................................................................................................................... 101
Testing procedures .................................................................................................................................... 102
Management menu / Maintenance ...................................................................................................... 102
Display and Touch screen ...................................................................................................................... 102
Testing the Display ............................................................................................................................ 102
Testing the Touch Sensitive Area ...................................................................................................... 102
START button ......................................................................................................................................... 103
Power board (SOURCE) ......................................................................................................................... 103
Manual (flexible) sampling tip ............................................................................................................... 103
Closed sampling..................................................................................................................................... 103
Sample mixer ......................................................................................................................................... 103
Shear / Sampling / Ceramic Valve ......................................................................................................... 104
Main Injector ......................................................................................................................................... 104
Mini Injector .......................................................................................................................................... 104
Valves .................................................................................................................................................... 104
Pump ..................................................................................................................................................... 104
Recommended set of tools ....................................................................................................................... 105

WARNING
Risk of personal injury. Movements of motors are controlled by limited current. Do not
override built-in safety measures, do not short circuit fuses
BIOHAZARD
Risk of biological infection, contamination
WARNING
The analyzer should only be operated without covers with extreme caution, moving
parts can cause injury. High Voltage board HVDCDC produces 180VDC.
Service marked components only when the power source is disconnected.
WARNING
Risk of personal injury. The ceramic shear valve has a sharp needle installed. Avoid
touching the needle

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Introduction
Norma Icon is a small, 60 tests/hour impedance based hematology analyzer for small to medium sized
laboratory use, performing 3-population analysis of human whole blood samples.

Icon is easy to use, uses low amounts of reagent for determining 20 hematology parameters.

Icon’s small footprint allows operating in space-constrained environments.

Who should read this manual

This manual is written for Service Engineers responsible for maintenance and troubleshooting of Norma
Icon, describing the structure of the analyzer, service and repair tasks. Reading this manual is intended to
provide confidence to keep the analyzer in good working condition and to ensure reliable and
dependable operation.

This manual is best used after having completed a training course about Norma Icon service tasks.

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

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 specification 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 actually delivered product.

Performance and reliability are never influenced by minor visual differences to the manual.

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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
Serial number

Technical contact
Icon 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 built-in safety measures might not work properly.

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 and service staff 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 comes with a 2 years manufacturer’s warranty against workmanship defects. Warranty claims
must be made through your local representative.

Warranty is void if any of the below can be identified:

- Intentional damage
- improper use, use against the instructions included in this manual
- irresistible natural disaster
- uncertified power supply, or unapproved peripheral has been connected to the analyzer
- repair by unauthorized staff
- damage can be rooted back to unreported shipping and/or installation induced activities.

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Measurement technology
Icon uses impedance (Coulter) method to measure the size of cells passing through an aperture. The
sampling system takes a small amount of whole blood from a closed or open sampling vial, and uses
diluent to create necessary dilution rates and adds lysing reagent to the solution to measure HGB and to
differentiate WBC. After the measurement process, critical sections of the tubing system are rinsed.

HGB value determination happens by measuring the rate of light absorption of the diluted and lysed
sample at 540nm.

Icon uses volumetric impedance method combined

with microfluidic photometrical measurement to
provide 22 hematology parameters of an aspirated
sample volume of 2.4ul of whole human blood
samples. The measurement cycle time is below 60
seconds yielding 60 tests/hour throughput.

Impedance based cell counting

Cells found in a blood sample have various sizes, (mostly) spherical shape with various diameters. The
size of these particles can be measured electronically.

A known direct current (I) is driven through a small opening (aperture) with known diameter
(comparable to the size of the particles, usually 70-100µm) separating two liquid compartments
containing the same conductive liquid. Particles are suspended in the conductive liquid.

When there is only liquid in the aperture, a certain electric resistance can be measured due to the
conductive characteristic of the liquid.

Particles (cells) do not conduct direct current. When a particle (red) passes through the aperture (yellow)
then the conductive cross section of the aperture filled with conductive liquid will decrease, and a
resistance different from that of the “empty” aperture can be registered over the liquid.

The change of resistance is proportional to the size of the non-conductive particle partially blocking the
aperture. The bigger the change, the bigger the particle passing through the aperture was.

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Hematology parameters
Parameter name Explanation Typical units

3 9
WBC White blood cell count 10 /µL & 10 /L
6 12
RBC Red blood cell count 10 /µL & 10 /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 %
3 9
Plt Platelet (thrombocyte) count 10 /µL & 10 /L
MPV Mean Platelet Volume fl
PCT Plateletcrit %
PDWsd/cv Red blood cell distribution width %
P-LCR% Platelet Large Cell Ratio %
ratio of PLT’s with volume above 12fl
compared to the total PLT count
3 9
P-LCC Platelet Large Cell Count 10 /µL & 10 /L
number of PLT’s with volume above 12fl
3 9
LYM# Lymphocyte count 10 /µL & 10 /L
3 9
MID# Mid cell count 10 /µL & 10 /L
3 9
GRA# Granulocyte count 10 /µL & 10 /L
LYM% Lymphocyte percentage (of WBC) %
MID% Mid cell percentage (of WBC) %
GRA% Granulocyte percentage (of WBC) %

3-part differentiation of White Blood Cells

Three-part white blood cell differential counts (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 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.

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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 10-15ul of blood, 2.4ul of which is used for the measurement. After
sampling, the sample vial is returned and ejected in the top of the vial holder.

A ceramic shear valve guarantees precise sampling volume. The 2.4ul of blood is mixed with isotonic
diluent to create a dilution of approximately 1:200 dilution rate (primary dilution). 3ul 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. The rest of the primary dilution is mixed with cyanide-free hemolysing reagent
and is aspirated into a syringe. The secondary dilution is aspirated into a second syringe.

The syringes use air bubbles to homogenously mix the respective dilutions inside. A positive pressure
(max 200mBar) is generated in both syringes and measurements start. The positive pressure forces both
dilutions through their respective measuring heads composed of apertures of 70um and 100um 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.

As a final step, the system empties the measuring elements and is ready to take the next sample.

Supported blood collection tubes

Icon can process human whole blood samples from open or closed sample vials.

Icon’s closed tube mode supports the following closed sample vials:

- BD Vacutanier (13x75mm) or compatible,

- Greiner Vacuette (13x75mm) or compatible,
- Sarstedt Monovette (11..13x66mm) or compatible,

Please consult the Instructions for use of relevant primary sample tube types.

Icon requires a minimum of 300µl of primary blood to be present in the closed vial for safe sampling.

Icon’s open tube sampling supports any whole human blood collected in sample vials prefilled with
potassium-EDTA or prepared accordingly.

Icon’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 minimum 200ul.

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Samples must be thoroughly mixed and homogenized adhering to general blood sample collection
guidelines prior to analyzing them on Icon.

Technical Specifications
List of measured parameters: WBC, LYM, MID, GRN, LYM%, MID%, GRN%, HGB, RBC, HCT, MCV,
RDWsd/cv, MCH, MCHC, PLT, MPV, PCT, PDWsd/cv, PLCC, PLCR
Histograms: WBC, RBC, PLT
Sample volume: 9.6µl from open vial; 13µl from closed vial;
(actually processed: 2.4µl; with EDTA)
Throughput: 60 tests / hour (closed vial mode)
Measurement technology: Volumetric impedance measurement combined with
microfluidic chip
Precision: WBC: 3%, RBC: 2%, HCT: 3%, MCV: 2%, HGB: 2%, PLT 5%
Storage capacity: 100,000 test results including histograms and patient data
User interface: LCD, 10.1”, 1280 × 800 with capacitive touchscreen, portrait
Dimensions (HxWxD): 263 x 206 x 313 mm
Weight: 9.7 kg
Power: external power supply, 12 VDC, 5A (96-243VAC @ 47-64Hz).
Power consumption: Maximum 45W
Real time clock backup power Lithium battery: Maxell CR1220 (3V)
WARNING: Only qualified service personnel may replace the internal fuse and battery.

Reagent consumption Diluent: 5.0 ml / Lyse: 1.0 ml / System solution: 1.0ml

Storage conditions: Temperature: 10-40°C (59-82.4°F)
Humidity: 20-80% relative humidity
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.
Operating Environment Temperature: 15-28°C (59-82.4°F), Humidity: 20-80% relative
humidity
- Atmospheric pressure The analyzer is designed to be operated up to 3000m/1000ft
above sea level (atm. press. Min: 523mmHg/69.7kPa)
- Power: Stable (as per power supply specifications), usage of UPS is
recommended to overcome power system fluctuations
- Do not place the analyzer near a direct heat source or into direct sunlight
- The desk supporting the analyzer should be flat, horizontal and stable enough to support the
weight of the analyzer and its optional accessories
Operating the analyzer outside the above specified environmental conditions may impair
operation and may also cause erroneous results or faulty operation.

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Description of the analyzer
Icon is a small desktop analyzer with a small footprint. The front side of the analyzer is occupied by a
large touchscreen display. The right front side hosts an opening for a flexible sampling tip to support
sampling from open vials, and a button that serves as a power button and as a start (aspiration) button
for open vial sampling.

The top of the analyzer has a circular opening for closed vials.

Both the left and right sides are cover elements. There is no door to provide access to the internal
structures of the analyzer for the user.

The rear of the analyzer contains a power connector, ports for USB and Ethernet connections. The
bottom right corner of the rear plate has a reagent connector that allows connection of reagents
required for the operation of the analyzer.

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Identifying parts of the analyzer

Front and right side of Icon

1. Sample vial with closed tube

2. Status indicator ring
3. Front camera
4. Opening for open tube sampling tip (retracted)
5. POWER/START button
6. Display with touch screen

10

11

Left and rear side of Icon

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

page 14 / 106
Electronic components
SOURCE board

The source board is responsible for receiving input power from the analyzer’s dedicated external powers
supply. The power supply (SYS1443-6512-T3) provides 12V DC to the analyzer. The SOURCE board is
equipped with a 3.5A (SMD) fuse.

It is located below the opening intended for inserting a

closed vial sample. The light (white) ring surrounding
the hole in its center is the light-conductive plastic
“collar” of the open vial opening.

The SOURCE board also supplies power to all

components inside the analyzer through a so-called
LIN Bus providing 12V and a data communication
signal.

The SOURCE board also receives input and provides

visual (color) feedback through the START+LED board.

The source board is able to detect input power voltage. The SOURCE board can signal if there was a
problem with the input voltage from the power supply: the ring located around the closed vial on the
analyzer’s top cover can change its color.

Power level (V) Color of the top ring Note

8.0< No color No operation
<8.0-11.0< BLUE No operation
11.0-13.0 No color Normal operation
<13.0-24.0 RED No operation
24.0< No color Fuse blown

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FCTRL1, FCTRL2

Fluidic Controller boards (2 boards. These boards receive their power from the SOURCE board through
the LIN Bus. Each board can drive 2 stepper motors, can receive position signals (optical and/or
mechanical switches) and can control 6 electromagnetic valves. It is also able to drive a DC motor driven
peristaltic pump.

Location of the 2 FCTRL boards. White connectors

are the valve connectors. Each valve has two wires
(for the electromagnetic coil). Connectors are
labeled with their respective letters (see tubing
diagram).

Connection sequences of FCTRL1 and FCTRL2

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COLIBRI

COLIBRI is the CPU of the analyzer. It has the following peripheral connections:

- USB
- ETHERNET
- LVDS

LILIOM

This is the “motherboard” for the COLIBRI, providing physical connections towards peripheral devices.
The board has a battery installed to provide power for the real time clock. Always observe correct
polarity when replacing the battery.

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DHGB

Valve manifold (for single valve, valve not shown) and the DHGB board. The manifold has the 540nm LED
installed. (The images show TWO LED’s: one installed in the manifold of the WBC valve, one part of the
DHGB board)

It is a digital HGB module with an LED light source (540nm) installed in a valve manifold (connected via a
wire (red-black). The PCB has a light intensity detector, also containing the necessary control and
interpretation logic.

The socket is for the LIN bus connection.

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ETHERNET+USB SOCKETS (CONN)

These connectors are supplied from the COLIBRI through the LILIOM board. COLIBRI has 4 free to use
USB ports (2 of which are dedicated to the capacitive touch sensitive device and the built-in camera), and
one dedicated USB port to the DCENT controller board.

LCD – Display module – 1280x800 pixel, 10.1i, portrait (front and rear view below)

The display module receives signals from the COLIBRI through the
LILIOM board via an LVDS connection with LED backlight. The display
receives signals from the LILIOM board through a so-called LVDS flat
cable. This cable interfaces to the display through a red, T-shaped
adapter board.

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TOUCH-sensitive foil

A capacitive touch-sensitive film secured to the inside of the

front facing side of the top cover’s integrated transparent
panel. It has its own USB controller (not visible on the image)
connected to one of the USB ports on the COLIBRI through
the LILOM.

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CAMERA

A built-in USB camera to allow reading and

recognition of QR codes printed on reagent
packs.

START+LED

It serves as a measurement initiation push-button for open tube sampling and, visual (color) feedback of
open tube sampling process. It is located behind the START(power) button located on the right side
panel. It has SMD LED’s installed which serve as backlight for the START button.

page 21 / 106
HVDCDC

Delivers measuring voltage to the measuring blocks (APERTURES – 15-20VDC) and a cleaning voltage for
the APERTURES (180VDC)

DCENT

It is a controller interface between the COLIBRI and all moving and measuring equipment. It
communicates with motor, valve and measurement related elements via the LIN Bus. It also receives
treated analog signals from the amplifier modules and performs A/D conversion of measurement data.

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AMPLIFIER

Analog signal amplifier receiving signals from the measuring apertures. It contains two parallel
amplifiers, with two sockets for the electrodes in the measuring chambers.

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Mechanical components
SAMPLE MIXER

It is a disc shaped component with a circular opening on

its edge that receives closed sampling vials. The disc
performs a revolving movement, driven by a stepper
motor. The sample vial is secured in its position inside the
opening with a component similar to petals of a flower.
The top side of the sample mixer hosts an optical detector
which can decide whether a sampling tube is present and
whether it has a cap on. The closed vial is inverted during
the mixing process. The vial is prepared for cap piercing by
stopping it in an upside-down position right above the
piercing needle. The piercing needle is fixed, does not
move, the sample mixer pushes the cap of the vial ONTO
the needle, and pulls the vial along with its cap off of the
needle after sampling. After the sampling process, the vial
is rotated to the upright position and is returned back to the operator. For closed vial rotation and
sampling, the disc rotates anti-clockwise.

The mixer is built together with the open tube sampling’s flexible sampling tip. The tip is guided through
a pipe shaped metal tube. To present the flexible tip to the operator, the disc rotates clockwise. Anti-
clockwise rotation pulls the flexible sampling tip back into the analyzer’s body through a wash head
located near the opening for the flexible tip, inside the analyzer’s body.

MAIN INJECTOR

Main Injector is a double-syringe assembly operated by a stepper motor. The

motor drives a spiral axis, and moves the two glass syringes synchronously.

The glass syringes can be replaced individually. Pistons and glass tubes MUST be
replaced as a set.

The syringe module has an optical switch to sense reaching the zero position
which is used as a reference for the Fluidic Controller.

Tubes are connected by means of threaded, high pressure connections.

Injector#1 syringes are 10ml each. The syringes are installed with their ejection
points downwards.

page 24 / 106
MINI INJECTOR

Mini Injector is a small syringe dedicated to aspiration of micro-samples both from

closed and open vials. It is also equipped with optical switches to detect the
boundaries of physical movements.

Tubes are connected by means of threaded, high pressure connections.

WARNING
Risk of personal injury. Movements of motors are controlled by limited current. Do not
fool built-in safety measures, do not short circuit fuses
BIOHAZARD
Risk of biological infection, contamination
WARNING
The analyzer should only be operated without covers with extreme caution, moving
parts can cause injury. High Voltage board HVDCDC produces 180VDC
WARNING
Risk of personal injury. The ceramic shear valve has a sharp needle installed. Avoid
touching the needle

page 25 / 106
SAMPLING VALVE

It is a ceramic shear valve with two fixed disks and one moving disk in between
(capable of rotating 360°). The middle disk has through holes (of specific size and
volume) to connect the two fixed disks at specific locations. A washing belt
surrounds the central disk.

The static disks have threaded ports on their cylindrical faces that receive threaded high-pressure
connectors. The static disk has right angled tunnels inside connecting its side facing the central disk and
the threaded ports on its cylindrical face. The top disk has threaded holes on its top face to receive the
fixed piercing needle and the threaded connector of the flexible sampling tip.

The shear valve is driven by a stepper motor, equipped with a position encoder for precise position
detection.

The upper static disc has a threaded hole to receive the sampling needle with a pointy end. This needle
penetrates the caps of vials. Another threaded hole receives the flexible tip from the front of the
analyzer.

The shear valve is equipped with two ports (dedicated openings) for taking a closed and an open vial
sample. To ensure reliable sampling, and the guarantee the necessary sample quality, these dedicated
ports have optical sensors to detect presence of blood.

page 26 / 106
The static needle is cleaned by a washing head that is pushed
aside (off) the sampling needle during the upwards and
downwards movement of the vial held by the sample mixer
assembly.

The image on the right shows the spring-enforced washing head

bracket. The bracket is pushed down by the downward
movement of the closed vial. The washing head is not shown on
the image.

The flexible tip has its own washing head.

The sampling valve has three “belts” or

“loops” or “circles”.

Loop “S” carries sample (whole blood) either

from the fixed needle (closed vials) or from
the flexible tip (open vials) to the dilution
system.

Loop “D” carries 2nd sample from WBC dilution

process to the RBC diluting process.

Loop “C” is reserved for cleaning the space between the two fixed disks. This space is sealed by the
washing belt. This space can be primed and drained by the fluidic system.

The SAMPLING valve with the stepper motor and washing head comes as a module. Do not disassemble
the sampling valve module. In case of malfunction, please return it to the manufacturer for repair.

WARNING
Risk of personal injury. The ceramic shear valve has a sharp needle installed. Avoid
touching the needle

page 27 / 106
Hydraulic components
VALVES

Valves are grouped and are hosted by a manifold. The valves are
electromagnetic rocker valves with very low residual (dead) volumes.

The manifold has threaded holes to receive threaded high-pressure

tube connectors.

MEASURING BLOCK

The analyzer has two measuring apertures combined with measuring chambers. Each aperture is fixed
inside a plastic housing. The housing has threaded holes for secure tube connections.

Apertures are 70um and 100um (RBC, WBC). Purple color connectors represent RBC channel, yellow
color connectors represent WBC channel.

DROP (waste) chamber

This chamber is located beneath the measuring apertures and it receives liquids from the apertures.

page 28 / 106
APERTURE HOUSING

The aperture housing is made of two

pieces.

The LEFT side element TOP connector is

coming from the ceramic valve
(segment), the BOTTOM connector is
connected to the respective syringe.

The aperture is secured into the RIGHT

side element.

The LEFT and RIGHT elements are secured together by screws, sealing is provided by an O-ring in
between.

The black component is a one-way valve that provides a means to push substance (liquid) out through
the aperture, yet preventing backflow through the aperture.

The vertical drain tube exits into the DROP TRAY.

PERISTALTIC PUMP

The peristaltic pump is used to remove liquids from the analyzer’s tubing system (typically waste liquid)

The pump head is composed of two parallel tubes (liquid paths). The two paths operate in parallel.

TUBES

(Teflon) Tubes are equipped with threaded connectors

to withstand pressures and to provide error-free
connections. The tubes are sealed into their sockets with
special plastic elements..

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Electrical block diagram

Icon 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 PCB).

WARNING
Only qualified service personnel may replace the internal fuse.

The main controlling board hosts a computer module connected with the display and the touch sensitive
screen.

Motors and valves are controlled by a special board and measurement data processing is done by an
amplifier board.

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Fluidic system

Icon contains the following

key components:

Electronic boards (main

board, signal processing
boards, controller boards
for moving components,
display)

9 valves,

Motors (syringe movement,

ceramic valve movement,
pump, sample
mixer/sample unit),

Measuring assembly incorporating ruby apertures

The diagram can be found as an appendix to this manual.

There are no user serviceable components inside the analyzer.

Please do not attempt to open the external covers to avoid damage to the system and
avoid mechanical injury.

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Reagent consumption
Process Note Additional condition iSol (ml) iDil (ml) iLyse (ml)
Prime iSol Full prime, 1 cycle maximum 4,3 0,0 0,0
Prime iSol Full prime, 1 cycle Small injector DOWN 3,4 0,0 0,0
Prime iSol Full prime, 1 cycle After Prime iSol 3,5 0,0 0,0
Prime iSol Prime only, 1 cycle After Prime iSol 0,9 0,0 0,0
Prime iSol FILL only After Prime iSol 2,6 0,0 0,0
Prime iSol In each cycle Management/Prime 0,7 0,0 0,0
Prime iDil 1 cycle 0,0 1,0 0,0
Prime iDil In each cycle 0,0 1,0 0,0
Prime iLyse 1 cycle After Prime iDil 0,0 2,0 0,6
Prime iLyse In each cycle 0,0 0,0 0,6
Rinsing 0,0 4,6 0,6
Meas Close After flex tube has been retracted 0,9 6,4 1,1
Meas Close After Measure Closed vial 1,0 6,4 1,1
Meas Open After flex tube has been shown 1,4 6,5 1,1
Meas Open After Measure Open vial 1,4 6,5 1,1
Fast blank 0,0 2,5 0,4
Flex Tip Wash 0,9 0,0 0,0
Calib iSol 0,9 0,0 0,0
Calib iDil 0,0 0,8 0,0
Calib iLyse 0,0 0,1 0,3
SV Rinse 0,8 0,0 0,0
Closed Cleaning + 80uL external cleaner 0,3 0,0 0,0
Open cleaning + 4mL external cleaner 3,8 7,8 0,0

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Reagent system

Reagent pack
The Norma Icon reagent pack provides sufficient reagent to run
100 blood samples with the analyzer.

The pack contains all necessary reagents and a waste container.

The reagent pack is a single use consumable, with a special

connector preventing incorrect connection of reagents and the
analyzer.

Hematology reagent waste must be considered biohazard material. Always follow local
regulations regarding disposal of used consumables, and reagent.

Reagent bottles
Norma Icon is also suitable to run using reagents in individual, 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.

Each tube is equipped with a color ring indicating which bottle to connect it to.

Rear view (from tube side) of the reagent connector

Hematology reagent waste must be considered biohazard material. Always follow local
regulations regarding disposal of used consumables, and reagent.

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How does it work?
The following image will be used to walk you through processes and stages of operation. Below you will
find the fluidic diagram, where some parts (modules) are marked with color rectangles. You will also find
images of the analyzer without covers with the same color rectangles helping identify elements of the
fluidic system.

Elements marked with color rectangles can be found in the analyzer as indicated below:

Left (“sampling valve, sampler-mixer”) side Right (“syringes, measuring block”) side

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Elements of the fluidic system

The fluidic system of the analyzer can be separated into two parts. These two parts are separated by a
dotted line on the image above. Left is the “sampling” side, right is the “dilution/measurement” side.

Left side – sampling

This side uses Norma-iSol3 as a lubricating and sample moving liquid. Two positions of the SAMPLE loop
of the ceramic valve are located in this section. S1-S2-S3 are ports on the ceramic valve, that can be
connected by the specific opening on the central disk of the ceramic valve. When the central disk rotates
so that it connects the upper and lower disks at position S1, then the liquid (blood) aspirated into the
section located in the central disk can then be moved to an another port like S2.

For closed vial sampling, ceramic valve will be positioned to connect S1 ports, the blood sample will be
aspirated trough the piercing needle into the central section. This section is then moved to the position
when it connects S2. S2 ports are connected to elements in the “right” side of the fluidic system. This
way, symbolically, the shear valve literally “takes the sample” from the sampling system into the dilution
system (right side).

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The measurement process

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Installation
Note

Icon is a precision hematology analyzer. Incorrect handling or accidental falling of the

analyzer may damage parts inside and could influence performance.

1. Carefully remove Icon 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, 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.

Attention
If you experience any error, like smoke, immediately disconnect the power cord from the
power outlet.
Use a fire extinguisher if necessary.

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.

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

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

Mouse (optional)
Icon 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.

USB Wi-Fi Dongle (optional)

Offers connectivity options to wireless networks (sending measurement reports via email).

USB flash drive (optional)

You can connect a USB flash drive to save reports, archive settings and database content.

page 44 / 106
Service menu
The service menu is protected by a gesture code. To enter the menu, perform the following sweep
gestures on the large black area of the screen:

RIGHT-LEFT-RIGHT-RIGHT-TAP-TAP

The service menu will display system data, allow checking and changing ID’s of the instrument and built-
in modules. It also offers adjustments of some measurement related parameters. Do not change these
settings.

Service menu tree

- Product ID screen; information about the analyzer and its electronic components, boards
- Sensors; enable-disable-calibrate sensors
(5 sensors: diluent, lyse, system solution, closed sample, open sample )
- Stress; initiate cyclic background measurements to clean or verify cleanliness of the system
- Fluidic system; access and test components included in the fluidic system
- Sample Rotor; access and test sample rotor
- Amplifier test
- Service Settings;
- Additional tests
- ER mode settings

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Product ID screen
This screen shows information about the analyzer and its
electronic components, boards.

Each board has its ID, Serial number, Software/Firmware

version.

The boards listed are the ones that are connected to the
internal LIN bus. In the factory, all boards will receive the
serial number of the analyzer they are installed in.

Sensors
Sensors are optical sensors that detect light intensity (IR)
through sections of tubes inside the analyzer.

Enable-disable / calibrate sensors

(the system has 5 sensors: diluent, lyse, system solution,
closed sample, open sample)

Sample sensors (closed sample, open sample) cannot be

deactivated or calibrated in service level.

Calibration will reset and set sensors concerned by checking

empty and liquid-filled state of the relevant tube section.

Expected values: 15 - 40. A value of <15 indicates faulty

reagent sensor calibration. Auto-calibration will accept values
between 15 and 40. To set manual calibration has no
limitation.

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Stress
Initiate cyclic background measurements to clean or verify
cleanliness of the system.

Amplifier test
The histograms should show 2 big peaks, some smaller additional peaks are allowed. Values must fall
within the below ranges (values out of range are marked with ‘↑’,’ ↓’ and red color):

AMP-A0
MIN MAX
v1.2
Noise 0 25
Pulse 15838 15846
PulseNoise 0 25
Peak 206 219
Width 3 5,5
Length 122 122
Vmin 456 470
CH0 (RBC) Vmax 456 470
Noise 0 15
Pulse 15838 15846
PulseNoise 0 25
Peak 224 237
Width 2,5 6
Length 122 122
Vmin 456 470
CH1 (WBC) Vmax 456 470

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Fluidic system
Access and test components included
in the fluidic system.

The entire system (mechanical

components) can be forced into a
continuous initialization process. This
process will make every moving
component be verified against its
position boundaries (sensors) passing
all tests and control parameters. The
process can be interrupted.

Valves can be toggled on and off

individually.

The pump can be toggled on and off.

Mini Injector tests allow moving

(PUSH/PULL) the sampling injector
with a defined number of STEPS with a
set POWER. The state of the position
sensor is indicated by the “OPTO”
light. (green when active)

Main Injector tests allow moving

(PUSH/PULL) the sampling injector
with a defined number of STEPS with a
set POWER. The state of the position
sensor is indicated by the “OPTO” light. (green when active)

Shear Valve

SV TEST initiates testing the ceramic valve by moving it and verifying correct movement. During the
test, the system will check and display the backlash value. The BACKLASH value is the number of
steps the mechanics needs to get the central disc moved in the reverse direction.

Buttons “POS0-10-20-35-45-55” stand for positions of the central disc (number of steps). By moving
the disc to various positions, different sections of the top and bottom discs get connected.

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Sample Rotor
Access and test the sample rotor and
its functions.

INIT is starting an initialization process

of the sample rotor. SENSORS (cap and
vial) are disabled. Make sure there is
no vial in the sample rotor when
forcing an INIT sequence.

“PrePierce” turns the rotor upside

down.

“Piercing” pushes the vial onto the

sampling needle.

The number “Piercing Step” provides

parameters for the “Piercing”
operation. The rotor will push the vial
down by as many steps as what is
defined above. The downward
movement is limited by a micro-switch
to avoid damage to the mechanics.

“PostPierce” removes the vial from

the sampling needle.

“Release” returns the vial through the

opening on the top.

Statuses of sensors are indicated beneath the image of the sample rotor.

“Show Tip” will show the flexible sampling tip.

“Hide Tip” will retract the flexible sampling tip.

“Test #1” and “Test #2” will repeatedly perform the steps described on the screen.

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Service Activity #3
LED test executes a color (red-green-blue) test on
SOURCE LEDs and on the START button LEDs.

Valve test switches all valves on and off.

HGB test reads HGB sensor and displays last 5 values.

Optionally HGB LED could be switched on/off.

HGB temperature displays the actual temperature on

DHGB board. *

*= requires DHGB board 2.1 and DHGB firmware 2.4

Service settings
Open sampling setting defines length of the open mode
sampling travel path.

HGB offset defines the value of HGB offset.

Thin sampling tube marks whether the analyzer is built with

thin sampling tip.

Calibration password needed activates password protected

calibration.

IsDemo activates demo mode which eliminates fluidics

activities (Sampling Rotor keeps moving).

Custom Table Wizard enables the option to run custom

program tables from \USB HD\Programs directory.

Data defined in Distributor field appears in About menu as

Distributor value.

Clear Log clears log entries, merges user calibration factors to factory level (reset user calibration factors
to 1.0), deletes results and resets the default settings. These activities can be combined according to
checkboxes.

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ER mode settings

Enabling ‘Auto-increment option hidden’ checkbox hides auto-

increment option in ER mode.

Enabling ‘Open Mode hidden’ checkbox hides open mode

selector in ER mode.

Enabling ‘Forced SampleID’ checkbox requires mandatory

SampleID field in ER mode.

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Maintenance

User maintenance
The user should regularly clean the visible surface of the manual sampling position’s washing head. It
should happen with a damp cotton swab. Protective gloves should be worn to avoid contamination.

Also on a regular basis, the user should run a closed vial filled with concentrated cleaning solution. This
will clean the tubing system.

To clean the flexible sampling tip and the corresponding tubes, an open vial prefilled with concentrated
cleaning solution should be run as a sample.

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Preventive maintenance
Twice a year, or after every 8000 samples (whichever comes sooner), preventive maintenance actions
should be performed. The analyzer covers must be removed, and lubricant should be applied over the
following components:

- Main injector spiral axis

BIOHAZARD
Risk of biological infection, contamination
Always wear protective gloves when servicing the analyzer
WARNING
Risk of personal injury. The ceramic shear valve has a sharp needle installed. Avoid
touching the needle
- Gears of the sample mixer should be lubricated.

Operation of mechanical components should be verified:

- Flexible sampling tip mechanics

- Sample mixer
- Cleaning should be run on the system using external concentrated cleaning solution

Service visit
A service engineer should check and record the following data for statistical and analytical data:

- STATISTICS: number of samples, errors

- LOGS: user, error, measurement
- CONSUMPTION: reagent, reagent pack

A calibration should be run, and QC measurements must be performed after any service action that
concerned components in relationship with hydraulic system. (Tubes, apertures, chambers, tube
connections.)

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Software upgrade
You are going to need a USB Stick with at least 50MB free space.

The package is contained in a compressed .zip file. Download the Software Package from Norma’s
Download Section. A username and a password will be required.

Extract the downloaded file to a USB stick, making sure that (1) the folder structure is maintained, and
(2) the folder (“nectar”) is located in the root folder of a USB stick. The file should reside on the USB stick
as follows (screenshot from Windows7 Explorer)

Connect the USB Stick to a free USB port on the back of the analyzer.

Start the analyzer. Go to Supervision, About.

Swipe to “Upgrade” page (page3).

The SW will indicate that a USB upgrade is available (“Copy 0.1.306.0”).

Tap “Copy…”.

The SW will copy the new SW install package to the analyzer. When finished, the message “Copy…” will
change to “Done” and will become inaccessible.
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Power off and on the analyzer by pushing the START button for 4-5 seconds, until the analyzer powers
off. Press the START button again to power on.

The installation needs your confirmation. Tap “Yes”. A Safety Backup will be created, and Installation will
commence. The process will end within a minute. If there was any error during the upgrade, the analyzer
will revert to the old software, no data will be lost.

After a successful upgrade, the analyzer will automatically restart and the main menu will be displayed.
You can verify the successful upgrade by checking the software version under
“Supervision/About/Product Info”.

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Troubleshooting

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.

Mechanical Errors

Error message Reason for error Remedy

Shear Valve error. An error The ShearValve could not be Run Shear Valve Rinsing a couple
occurred while testing Shear moved from and to its zero times (Service Menu), then try
Valve backlash. position. The disks are again.
temporarily stuck together.
Mechanical error
An error occurred while The pump may be blocked or Operate the pump from the
attempting to use pump. faulty. service menu. Check electrical
connections, operation. Look for
blocked output.
Sampling Rotor error. An error Error (block) during operation. This is a 2 part message. Please
occurred while attempting to use go to Supervision/History/Error
Sampling Rotor (unspecified and check the rest of the
error). message. Go to Technical Details
of this section.
Sampling Rotor error. An error Error (block) during operation. This is a 2 part message. Please
occurred while attempting to use go to Supervision/History/Error
Sampling Rotor (Sampling Rotor and check the rest of the
invalid position). message. Go to Technical Details
of this section.
Valve error. An error occurred Internal SW structural problem. Check valve operation in service
while attempting to set valve. menu.

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Operation related errors

Error message Reason for error Remedy

Communication error. An error Possible network error Verify network connection.
occurred while sending an e-mail
(connection exception).
Control assay sheet already The QR code has already been Use another code or drop
exists. scanned. pervious entry.
Communication error. An error Possible network error The error is not critical. Verify
occurred while attempting to network connection.
download software upgrade file
(unspecified error).
Measurement error
QC LOT field cannot be empty. You left the QC LOT field empty. Fill in data.
QC with defined LOT already You scanned/defined a QC lot Review QC data, or drop
exists. that has already been defined. matching records in QC LOT list.
An error occurred while The code is wrong. Verify system ad QR code version
decoding QR code (invalid or requirements. Consult
broken QC code). TechSupport.
Reagent detection error. An
error occurred while attempting
to calibrate reagent sensor at
Diluent inlet.
Reagent detection error. An
error occurred while attempting
to calibrate reagent sensor at
Lyse inlet.
Reagent detection error. An
error occurred while attempting
to calibrate reagent sensor at
System Solution inlet.
Tube Detector warning (missing Error (block) during operation. This is a 2 part message. Please
condition). go to Supervision/History/Error
and check the rest of the
message. Go to Technical Details
of this section.
Tube Detector warning (insert A closed sample measurement Insert a vial and retry. If the
tube). was initiated without inserting a problem persists, check the
vial. operation of the tube sensors in
Service menu.
Tube Detector warning (remove An open sample measurement, Remove the vial and retry. If the
tube). or a procedure that uses the problem persists, check the
sample rotor was initiated while operation of the tube sensors in
a vial was left in the sample Service menu.
rotor.

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Error message Reason for error Remedy
Sampling Tip warning (active Error (block) during operation. This is a 2 part message. Please
open mode). go to Supervision/History/Error
and check the rest of the
message. Go to Technical Details
of this section.
Sampling Tip warning (inactive Error (block) during operation. This is a 2 part message. Please
open mode). go to Supervision/History/Error
and check the rest of the
message. Go to Technical Details
of this section.
User error
An error occurred while sending Email account data are incorrect Check account data, test email
an e-mail (username or password settings.
exception).

Electronic errors

Error message Reason for error Remedy

Camera error. An error occurred The camera failed. You will not Use manual mode or USB based
while activating camera. be able to scan QR codes with entry for inputting QR code data.
the camera. Contact TechSupport.
System (software) errors

Error message Reason for error Remedy

Database error. An error File system corrupted. The error is not critical. If the
occurred while attempting to system keeps running, inform
read/write database. TechSupport. If the system
freezes, reinstall the SW.
Database error. An error File system error. The error is not critical. If the
occurred while attempting to system keeps running, inform
create record in database. TechSupport. If the system
freezes, reinstall the SW.
Communication error. An error Internal SW error The error is not critical. Report to
occurred while attempting to TechSupport.
read/write ProductID.
Fluidics error. An unknown low- This is a 2 part message. Please
level error occurred while go to Supervision/History/Error
attempting to execute fluidics and check the rest of the
function. message. Go to Technical Details
of this section.
Fluidics error. An unknown error This is a 2 part message. Please
occurred while attempting to go to Supervision/History/Error
execute fluidics function. and check the rest of the
message. Go to Technical Details
of this section.

page 58 / 106
Error message Reason for error Remedy
Fluidics error. An unknown error This is a 2 part message. Please
occurred while attempting to go to Supervision/History/Error
get/set arguments of fluidics and check the rest of the
subsystem. message. Go to Technical Details
of this section.
Processing error. An error This is a 2 part message. Please
occurred while attempting to go to Supervision/History/Error
process raw measurement data. and check the rest of the
message. Go to Technical Details
of this section.
System error. An error occurred Internal SW error The error is not critical. Report to
while attempting to query active TechSupport.
QC LOT.
Communication error. An error Internal SW error The error is not critical. Report to
occurred while attempting to TechSupport.
open serial port.
System error. An error occurred Internal SW error The error is not critical. Report to
while attempting to play sound TechSupport.
file.
Communication error. An error Internal SW error The error is not critical. Report to
occurred while attempting to TechSupport.
print with thermal printer.
Reagent detection error. An
error occurred while attempting
to detect Diluent.
Exporting error. An error The USB storage device was not Try to reconnect the device or
occurred while attempting to connected or it is faulty. use another USB socket.
export Tab Separated File.
Communication error. An error
occurred while attempting to
send e-mail (unspecified error).
An error occurred while Internal SW error The error is not critical. Report to
attempting to set volume. TechSupport.
Software error Internal SW error The error is not critical. Report to
TechSupport.
System error Internal SW error The error is not critical. Report to
TechSupport.
System error. An error occurred Internal SW error The error is not critical. Report to
while attempting to initiate TechSupport.
system (unspecified error).
Reagent detection error. An Bubbles detected in tubing inside Verify external tubes for possible
error occurred while attempting analyzer. kinking. Verify tubes inside
to detect Lyse. analyzer for presence and origin
of bubbles.

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Error message Reason for error Remedy
Reagent detection error. An Bubbles detected in tubing inside Verify external tubes for possible
error occurred while attempting analyzer. kinking. Verify tubes inside
to detect System Solution. analyzer for presence and origin
of bubbles.
Reagent system error. An error An already expired reagent was Use a new reagent.
occurred while attempting to scanned, and the user made an
activate reagent (already attempt to activate it.
expired).
System error. An error occurred Internal SW error The error is not critical. Report to
while attempting to modify TechSupport.
reagent’s tracking level.
System error. An error occurred Internal SW error The error is not critical. Report to
while attempting to query active TechSupport.
reagents (inactive or expired
reagents).
Reagent detection error. An Internal error. The system Please disable reagent sensors.
error occurred while attempting cannot interpret sensor data. Report problem to TechSupport.
to read reagent sensor data.
Firmware Error Internal SW error The error is not critical. Report to
TechSupport.

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Technical Details of an error message
A typical error message is composed of the error type, and error location. Error messages are displayed
in a small pop-up bubble in the lower right corner of the screen. Details listed below are only accessible
from the History / Errors section.

One example:
*Tap to release Error
The user will only see the first part of the message.
Technical details are only available from the Fluidics error. An unknown low-level error occurred
Supervision/History/Errors section. while attempting to execute fluidics function.

Motor: SamplingRotor
TestFM
TestSVPos / Executeprogram / DCent (DE_ID: 2)

Additional info will help determine the source and *Tap to release Error
type of the error. Here are the “fields” based on <Main error message>
which the errors can be classified.
<Source (component)>
These fields will be important to contact <Process>
TechSupport. <Process Section / SubProcess / Parameters>

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Collecting Diagnostic Information
Icon offers many ways to see the details of operation and to diagnose and resolve problems.

Diagnostic File
Available:

- Supervision/About/Page3:
o Diagnostics / USB Stick: Save (only active if a USB stick is connected)
o Diagnostics / Internet: Send (only active if internet (network) connection is available)

Purpose:

- Provide data about:

o Measured values, Histograms, Probe voltages, Flags
o Log events (error messages, operation, reagent data, system events)
o Calibration data, calibration factors
o QC performance
o Settings (excluding email account settings)
o System information (SW version, electronic modules)

Output:

- All the above are packed into a password protected ZIP file.
o The ZIP file (USB)
o An email to TechSupport with the ZIP file as attachment

TSF files
Available:

-Execution / Results / Local menu

Purpose:

- Provide data about:

o Measured values, Histograms, Probe voltages, Flags

Output:

- All the above are packed into a text file (Tab Separated values file Format)
- The file is a (TXT) file (ASCII) with header information.
- It can be processed in e.g. Microsoft EXCEL.
- Histograms, and curves are saved as strings (series of characters) in Base64 coded format
- For Base64 coding/Decoding, please see: http://www.base64decode.org/

page 62 / 106
Raw measurement data
Available:

- Special software tool.

- This tool is not provided by default.
- When necessary, you’ll be guided by TechSupport.
- You’ll need a USB stick to save data.

Purpose:

- Provide data for off line processing (running) of the actual measurements of the analyzer
- You can save raw data files (digital info) for selected days with the help of a small utility (not part
of Icon Software)

Output:

- A folder (typically saved on a USB stick) containing files with digital information about
measurements.

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Technical flags (results)
All flags can have a “weight” or “strength” ranging from 1 to 9. The weight affects how Iocn displays
measured values.

 1-2: There is no influence over results, flag is not displayed

 3-5: A flag is displayed. Results are displayed and are reliable. Flag indicates that the sample was
causing minor irregular events during the process, but the system is able to compensate or
tolerate them. Continuous presence of the flags though requires verification of various system
components, procedures.
 6-9: A flag is displayed. Results are dashed out - - -, because the algorithm could not evaluate the
sample within its safe operation zone. Rerunning the sample may help if the problem was
temporary. Continuous “heavy” flags require service visit, and verification of system elements.

Types of flags and description of triggering condition(s)

Atypical 3part
The processing algorithm found a WBC distribution that does not match standard criteria. Rerun the
sample.

Distortion
Cells passing through the aperture induce false or incorrect pulses. Most likely the aperture is leaking
and additional currents are causing false readings.

Improper Voltage
Probe voltage is outside its expected range. WBC probe voltage is OK around 350 +/- 30, RBC probe
voltage is OK 460 +/- 30. If these are outside the defined ranges, then it is either too cold or too warm to
operate icon. A partial clog can also increase probe voltages. It is not likely to have both probe voltages
elevated because of simultaneous clogging.

If voltages are above 800, then the aperture is not

connected to the amplifier, or the amplifier is damaged,
or the platinum and gold plated socket has contact
problems.

If probe voltages are below 20, then there is either a very

definite short circuit in the amplifier, or most likely it has
cable connection failure around the amplifier/HVDCDC.

Improper voltage can also be triggered by too low or too

high operating temperature.

Probe voltages are 330 and 460 (WBC, RBC) at 22°C. Every 1°C increase causes a 4 units decrease in
probe voltages. This means then 30/6 = 5 degrees difference in temperature will push the probe voltage
to its “edge”. Being there will not influence measurement results, but will trigger Improper Voltage flags
at a strength of 3-4. This is OK, and the analyzer can deal with it.

page 64 / 106
Inadequate Lysis
The number of cells passing through the aperture in the given
slice of time is decreasing. This can be caused by
inhomogeneous (lysed) sample, low (lysed) sample volume.

Both causes are rooted from inadequate amount of sample in

the WBC syringe. Most likely there are bubbles formed in the
system somewhere AFTER the LYS and DIL detectors.

- Look for loose connectors, damaged, leaking or

cracked aperture house.
- Check that LYS and DIL detectors are enabled and are
working.

Noise
This flag indicates that the measurement algorithm found “too many” PLT-like or smaller pulses during
measurement. This can really be PLT-s, but most likely these come from either physical particles or from
bubbles, microbubbles.

Bubbles (if stuck in the aperture house) can cause a periodic

vibration in the flow of the diluted sample through the
aperture and this vibration can be represented by small noise-
like pulses. These pulses will be displayed on the histogram like
a high peak in the beginning of the graph.

(External, intensive electronic pulses can also be represented

in the form of high peaks)

Physical particles will however be distributed over the

beginning of the graph more evenly.

Low sample volume

ICON has two sample detectors, one for each sampling mode. This flag is triggered when the actual
detector could not see blood sample present in the internal tube system.

Either the sampling was not successful (low volume) or the blood is too “thin” (diluted). Rerun the
sample.

If this flag keeps coming up, then you should verify the operation of the detector itself.

page 65 / 106
Overload (X)
This flag is typically displayed along with Improper Voltage or Noise flags. This indicates that there were
way too many pulses detected than what could be detected and analyzed.

Range Exceeded
This flags gets triggered when the analyzer is close to or beyond its limit of operation, limit of linearity.
Results will be dashed out when measured values go beyond 100 x 103 WBC/uL.

Unstable HGB
The HGB sections (partial HGB measurements) were
detected to have a fluctuation beyond normal ranges.
This means that the HGB concentration was not even
enough from section to section.

This can be caused by uneven mixing of the diluted

sample and lyse reagent, or by bubbles present in the
sample (low lyse volume, leakage in the system). The
same symptom is arising if the (diluted) WBC sample runs out before the measurement (of the diluted
WBC sample) is over.

Unstable HGB Baseline

This flag indicates presence of bubbles in the HGB head during HGB blank measurement. Look for
bubbles in the WBC syringe during sample preparation.

Unstable Voltage
The probe voltage was found to vary beyond
limit. During measurement the probe voltage
is steadily increasing. Some minor jumps are
allowed, but sudden changes in the value
indicate partial clogging of the aperture.
These jumps are triggering this flag with
different strength. The sample running out before the end of the measurement cycle will also trigger this
flag: air will be present on both ends of the aperture and no current can flow.

You may also check whether the glass syringes are securely tightened into their respective bases. A loose
connection may induce variations in the flow of the solution.

WBC Channel Dirty

WBC measurement will have fake pulses arising from the presence of contamination, “dirt” behind the
aperture. These contaminating particles can be removed by a cleaning (open cleaning) process.

page 66 / 106
Electrical problems
Symptom Possible cause Remedy
Instrument cannot be powered Power is not connected Connect power source, verify
on connections
Power voltage is too high, or too Measure power source output
low
Fuse is blown inside analyzer Locate source of the problem.
Replace fuse on SOURCE board
Indicator on top of the analyzer Power voltage is too high Use correct power supply
glows in RED color
Indicator on top of the analyzer Power voltage is too low Use correct power supply
glows in BLUE color
Instrument powers down during Fuse is blown inside analyzer Locate source of the problem.
operation Replace fuse on SOURCE board
Power system fluctuations Try to start the analyzer again
Use a UPS
Software error message Corrupted SW system. Rerun SW installation
Touch screen does not react to Faulty touch screen Check touch screen flat cable
gestures and USB cable
Connect an external mouse for
temporary operation
Uncertain operation of touch Faulty touch screen Check touch screen flat cable
screen and USB cable
Remove top cover, remove
display plate, and check for
stable capacitive surface
installation
Connect an external mouse for
temporary operation

page 67 / 106
Mechanical problems
Symptom Possible cause Remedy
Sample vial is stuck in sample Power outage during operation Start analyzer again, initiate
rotor measurement sequence
Sample vial is not lowered, Cap detector faulty Verify cap detector sensors
system reports missing tube
Sample vial is not returned to Vial is stuck on sampling needle Start analyzer again, initiate
operator measurement sequence
Grinding noise from inside of Mechanical blocking Open analyzer, look for faulty
analyzer module. Find obstacle. Remove
obstacle (sampling vial?)
Analyzer reports empty Too low blood sample volume Run vials with correct sample
measurements volume
Too high vacuum in sampling vial Uncap sample to remove
vacuum. Rerun sample.

Grinding noise from inside of Wash head mechanics is dirty. See  closed wash head
analyzer and empty results, “Not Accompanied by grinding noise. maintenance.
Enough Blood…”
Leakage beneath analyzer Blocked shear valve Try cleaning.
Open analyzer, remove shear
valve and clean it. Check for
clean through holes and ports

Check connector, replace if

Leaking reagent connector necessary

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Hydraulic problems
Symptom Possible cause Remedy
Leakage from below analyzer Blocked shear valve Try cleaning.
Open analyzer, remove shear
valve and clean it. Check for
clean through holes and ports

Check connector, replace if

necessary
Leaking reagent connector
Instrument reports clogging Bad quality sample used Try to initiate a measurement.
Built in functions will try to
unclog needle and apertures.
Open analyzer, remove shear
valve and clean it. Check for
clean through holes and ports

Flexible sampling tube is not Tube has been pushed in by user Open analyzer. Realign tube.
pushed out during open tube Tube was broken by user, tube Open analyzer. Replace flexible
sampling cannot be pushed out tube module (pipe)
Leakage from the wash head of Clogging in washing head, salt Clean washing head.
the open tube sampling crystals Train user for user maintenance

page 69 / 106
Measurement problems
Symptom Possible cause Remedy
High BLANK values Contaminated reagents Replace reagents
Unearthed power outlet Install grounding for power
supply

Missing reagents, wrong results Reagent is out Replace reagents

Reagents are not connected Verify reagent connector
Reagent connector sealing Replace reagent pack, or replace
failure connector

Incorrect WBC differentiation Lysing reagent errors Check reagent connector

Low sample volume reported Too low blood sample volume Run vials with correct sample
volume
Too high vacuum in sampling vial Uncap sample to remove
vacuum. Rerun sample.
Leakage from rear reagent Reagent is out Replace reagents
connector Reagents are not connected Verify reagent connector
Reagent connector sealing Replace reagent pack, or replace
failure connector
Missing parameters Noise

page 70 / 106
Entering QC target values manually
1. Power on Icon.
2. Go to „Execution” / „Sampling”

3. Swipe left to access „Human/Control/Quality” Control screen

4. Tap „Quality Control”.
5. Tap „Add new…”

page 71 / 106
 6. Enter values form the assay sheet.
7. Enter LOT ID and Expiration date.

8. Accept your changes.

Once you ACCEPT the values you will not be able to change values.

page 72 / 106
Accessories
 external power supply
(SYS1443-6512-T3)

 power cord matching your standard power outlets

 reagent connector

 Operator’s manual

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

page 73 / 106
Service
Removal and installation procedures

WARNING
Risk of personal injury. Movements of motors are controlled by limited current. Do not
fool built-in safety measures, do not short circuit fuses
BIOHAZARD
Risk of biological infection, contamination.
Always wear protective gloves when servicing the analyzer.
WARNING
The analyzer should only be operated without covers with extreme caution, moving
parts can cause injury. High Voltage board HVDCDC produces 180VDC
WARNING
Risk of personal injury. The ceramic shear valve has a sharp needle installed. Avoid
touching the needle

page 74 / 106
Outer Cover
Icon’s outside covers are made of molded plastic. The top cover includes a bent polycarbonate sheet
with opening for closed tube insertion.

Side covers are secured with screws in the back of the analyzer. After removal of these screws, the side
covers can be removed as well. The right side cover has the start button built in.
(RED arrows indicate side cover screws)

The top cover is secured with screws on the upper rear edge of the analyzer, and three further screws on
the bottom front edge of the analyzer. The top cover has a bent polycarbonate plate and the display, and
computer module installed on. Additionally, the closed vial opening along with the power board is also
installed on the polycarbonate plate. The top cover has an additional screw fixing the top cover’s frame
to an internal metal plate. This screw becomes accessible after removal of the right side cover (cover
with START button)

(BLUE arrows indicate top cover screws)

page 75 / 106
Electronic boards

Motherboard (LILIOM) and CPU module (COLIBRI)

The motherboard that hosts the CPU module also resides on

the inside of the top cover’s front plane. (RED rectangle)

Touch

This board (GREEN rectangle) is the sensor board for the

capacitive touch-sensitive surface behind the front panel of
the analyzer. It is connected to the LILIOM board via a USB
cable.

Display (not visible, behind metal sheet)

The display module (RED rectangle, board is not visible,

resides BEHIND the metal plate) along with its controller
board, are installed on the inside of the top cover’s front
plane. Flat cables connect the display board and the
capacitive touch sensitive area to the respective controller
boards.

Washing head for manual sampling

The washing head of the manual sampling (flexible sampling tip) (BLUE rectangle) is fixed to the front
panel.

DCENT

This board is responsible for controlling motors and valves through the FCTRL boards. (YELLOW
rectangle)

page 76 / 106
Motor and valve controller modules (FCTRL1-2)

There are two identical boards positioned on top of one

another (YELLOW rectangle). These boards control stepper
motors and electromagnetic valves.

HVDCDC

This board is responsible for generating measuring voltage

and aperture cleaning voltage. (WHITE rectangle)

Amplifier modules, Amplifier interface

These boards (RED rectangle, boards are NOT visible,

behind metal casing) are responsible for receiving analog
signals and providing them to the DCENT board.

DHGB

This board (GREEN rectangle) is located below INJECTOR#1 and is responsible for getting HGB
measurements by detecting absorption of 640nm light from an LED by the means of a light intensity
detector.

page 77 / 106
Mechanical modules
MAIN INJECTOR
A stepper motor driven syringe pair. (WHITE rectangle)

A valve is located beneath each syringe. The WBC syringe

valve is combined with a HGB reading circuit (DHGB).

Peristaltic pump (RED RECTANGLE)

A DC motor driven pump used to remove liquids (waste) from

the analyzer through the waste nozzle of the reagent
connector.

Stepper motor of the sample mixer

(BLUE rectangle)

Apertures (YELLOW rectangle)

The analyzer has two APERTURES; 70um for RBC

and 100um for WBC counting. An aperture
house is made of two halves:

- one with the connections (from syringe

and from ceramic disc)
- the other with the aperture and with a
drop tube (and a one-way valve
incorporated)

The one way valve prevents aspiration of air

through the aperture during movement of the
sample to and from the syringe and the ceramic valve.

page 78 / 106
Sample mixer and flexible sampling tip
The sample mixer (GREEN rectangle) is a big Plexiglass disk
that receives the closed vial. It is operated by a stepper motor
behind the metal plate. The flexible sampling tip is also built
into the sample mixer with a bent copper pipe.

Valve module

The valve module (BLUE rectangle) hosts 7 electromagnetic

valves in a plastic manifold. Tubes are connected with
threaded connectors. Valves are controlled by FCTRL boards.

Shear valve

The shear valve (RED rectangle) is composed of three ceramic

disks and is operated by a stepper motor equipped with a
position encoder. Tubes are connected with threaded connectors. The shear valve’s upper (static) disk
has a sharp needle incorporated.

MINI INJECTOR

(ORANGE rectangle) This injector is operated by a stepper motor, and is responsible for aspirating
primary blood samples from closed or open vials.

Peristaltic pump

(YELLOW rectangle) This image shows the pump head only. The DC motor is located on the other side of
the metal plate.

Rear Reagent connector

(BLACK rectangle)

page 79 / 106
Disassembly procedures

Outer cover
Side covers are secured with screws in the back of the analyzer. After removal of these screws, the side
covers can be removed as well. The right side cover has the start button built in.
(RED arrows indicate side cover screws)

The top cover is secured with screws on the upper rear edge of the analyzer, and three further screws on
the bottom front edge of the analyzer. The top cover has a bent transparent plate and the display, and
computer module installed on. Additionally, the closed vial opening along with the power board is also
installed on the transparent plate. The top cover has an additional screw fixing the top cover’s frame to
an internal metal plate. This screw becomes accessible after removal of the right side cover (cover with
START button)

page 80 / 106
Remove the 6 screws indicated by blue arrows on the image above.

WARNING
Risk of damaging the analyzer if you fail to follow procedures described below.

The washing head of the flexible sampling tip is secured to the front panel. You may not simply lift the
top cover off, as this move can damage the flexible tip.

Prior to lifting the cover off, you need to remove the washing head AND the flexible tip.

Make sure the analyzer is off, or in an idle state.

Make sure the sampling tip arm is pushed back as far as possible.

Carefully turn the washing to arrange the two nozzles horizontally and away from the seat of the
washing head.

Gently pus the wash head back, taking the flexible tube with it.

Carefully get the flexible tube out of its track (be careful not to break or kink it).

Now you can pull the wash head off of the flexible tube.

page 81 / 106
The source board is secured to the inside of the top cover. Disconnect the GREEN power connector from
the source board.

Disconnect the LIN bus cables from the Source board to the Reagent sensor board

Disconnect the LIN bus cables from the DCENT board to the HGB board

Disconnect the network cable (blue connector) and network LED cable from the LILIOM board

Disconnect the 2 USB cables (blue connector) coming from the rear connectors from the LILIOM board

Now you may lift off the top cover.

page 82 / 106
Electronic boards
Boards are accessible after taking the top cover of the analyzer off. Before fully removing the top cover,
please make sure to disconnect the cable between the rear power socket and SOURCE board (situated
on the top of the cover).

Respective cables from the connector board and amplifier must be disconnected from the boards
located on the back of the cover.

The touch sensitive board is connected with ZIF flat cables. Take care when handling such cables and
connectors, these can get damaged easily.

ZIF connectors have a latch that must be disengaged prior to pulling the flat cable.

To reconnect a ZIF cable, make sure the latch is open, insert the flat cable with the handling-flap on top
as far as it goes (do not force the cable!), and close the latch.

page 83 / 106
HVDCDC

Connection to
AMPLIFIER

Disconnect cables, and remove screws securing the board to the vertical assembly plate.

Amplifier
Remove the chamber assembly, disconnect cables. Remove screws securing the amplifier to the
shielding plate of the amplifier board.

Connection to
Connection to HVDCDC (high
DCENT (control
voltage board)
board)

page 84 / 106
FCTRL board(s) replacement
Tools needed:

- Hex keys
- Allen key (6mm)

You will have to remove the left side of icon (the side without the power switch). The FCTRL boards
(responsible for motor and valve control) are located in the upper section.

The two boards are located above one another. The outer board has a JUMPER installed on its row of
pins. This is FCTRL2. The board below does NOT have a JUMPER. This is FCTRL1. (The JUMPER defines
FCTRL 1/2 role).

FCTRL board – no JUMPER installed over row of pins  FCTRL1

page 85 / 106
The description of connections is shown below. Not all connectors are labeled, however.

Procedure of replacement:

- Remove FCTRL2 (4 screws)

- Move the connectors from the OLD board to the replacement provided
- (Make sure to use FCTRL2, equipped with a JUMPER)
- Remove FCTRL1 (4 spacers – allen key or socket wrench: 6mm recommended)
- Move the connectors from the OLD board to the replacement provided
- (Make sure to use FCTRL1, the board without the JUMPER)
- Install FCTR1 using spacers
- Install FCTRL2 using screws

No programming or adjustment is required.

Test operation.

page 86 / 106
Mechanical units
Main Injector

Motor A B C D Valve HGB head+valve

The above image shows the Main Injector without the glass syringes. The two valves (and the DHGB
board) are visible on the right side (these are actually located UNDER the injector unit)

Disconnect tubes and cables. Remove screws securing the injector to the back plate of the analyzer.

Removal of syringes:

- Make sure the analyzer’s left side cover is removed

- The analyzer should be ON
o If it is not possible, you will have to move the moving plate (by its threaded axis) manually: twist
the axis manually.
- Go to Service, page displaying Pneumatic Functions, Big Injector section
- Press “Test NI Opto” to make sure the piston is in the bottom position
- Set steps: 1000. Tap „PULL”. This will move the syringes up so that you can remove them later on.
- Remove the screw from the RBC syringe’s plunger rod.
- Unscrew the RBC syringe.
- Remove the screw from the WBC syringe’s plunger rod.
- Unscrew the WBC syringe. Do not interchange syringes.

page 87 / 106
Installation of syringes:

- Match the length of the syringe so that the rod’s length allows
installing the fixing screw
- Install the WBC syringe, tighten using your index fingers. Do
not use tools.
- Align the piston rod’s opening a (orange arrow) little bit above
the threaded hole on the moving plate (green arrow)
- (Yellow arrow = opto pin  “Test NI Opto”)
o Move the rod by putting in the screw and pulling on
the screw itself, OR
o If you have to TWIST the rod to align its hole with the
moving plate, ALWAYS secure the syringe by hand
against untwisting while turning the axis. Not doing
so will release the threaded end of the syringe, and
will cause leakage at the bottom of the syringe,
resulting in:
 Leakage
 Repro problems
 HGB head and valve failure
- Tighten the TOP screw manually.
- Repeat the same procedure for the RBC syringe

NEVER try to manually tighten syringes with the piston rods secured to the moving plate.

When both syringes have been installed:

- Move the syringe up/down 200 steps 2-3 times (push/pull)

- Tighten the screws on the top of the piston rods manually.
- Verify the zero position by using the “TEST NI OPTO” function.
- Make sure the NI OPTO value is between 30 and 40, stable, not changing.
- Run a few prime Diluent functions to check if leakage is not seen.

page 88 / 106
HGB head replacement
Approximate time: 89pprox.. 30mins

Tools needed:

- HEX keys 2, 2.5, 3mm

- Wrench 10, 13mm

Procedure:

- Remove the left side cover (the one without the power button) (3 screws in the rear of the
analyzer)
- Power on Icon
- Go to Service Menu, and navigate to the page showing Valves, Injector, Sampling valve (page4)
- Make sure the injector is moved up
o use the “PULL” button at the Injector several times, so that you can see a 15-20mm gap
between the top of the glass syringe and the moving part of the injector

-
1.Fig 2. Fig

page 89 / 106
- Locate the WBC syringe (left syringe)
- Remove the thumb screw from the plunger.
(3.fig orange arrow)
- Unscrew the bottom of the syringe,
to remove it from its socket
- Take out the syringe, place it on a safe surface.
The syringe is made of glass.
Take care not to break it.
Do not disassemble the syringe and
the plunger

3. Fig

4. Fig

- Remove 3pcs of the Syringe Unit holder screws, except the top left one (3.Fig red arrow), which
has to be only loosened. By this way, you can tilt out the bottom of the syringe unit a little bit for
more space to the replacement.
- Locate the HGB board and its manifold (identical to the part you received)
- Disconnect the LIN cable (BLUE-RED-BLACK) (4.fig orange arrow)
- Remove the 2 screws from the top to release the HGB head-manifold-valve assembly.
- Remove the White and the Yellow plastic tube connectors.
- The HGB head – manifold – valve assembly will be in your hands.
- Use the 2 screws to dismount the valve from the manifold.
- Make sure not to lose the sealing element (3 o-rings, connected)
- Use the wrench to remove the Nut, Grounding Ring then the stainless steel Grounding Screw.
- Grab the replacement HGB head-manifold assembly.
- Use the wrench to reinstall the Grounding screw. Carefully tighten the screw to reach a sealed
connection but not crack the manifold! Reinstall the Grounding Ring and the Nut as well.
Tighten the Nut with caution, the nut can tilt the whole screw assembly more and can cause
cracking of the manifold.
- Install the valve over the new HGB head-manifold assembly. Do not forget to install the O-rings.
- Make sure to align the valve and the connectors and the screws, otherwise you’ll experience
leakage and incorrect behavior.

page 90 / 106
 - Reconnect the White and Yellow tube connectors.
- Reinstall the HGB head under the syringe (2 screws)
- Reinstall the mounting screws of the syringe unit.
- Reinstall the syringe (twist it in). Tighten it with your hand only. Do not use tools!
- Install the thumb screw in the top. Tighten it with your hand only. Do not use tools!
- Install the LIN cable
You are done!
- Power on Icon.
- Test operation (run measurements). Check the HGB head for possible leakage!

Mini Injector

Syringe Piston (not visible) Motor Opto sensor (position)

Disconnect tubes and cables. Remove screws securing the injector to the back plate of the analyzer.

The Mini Injector is a precision syringe with a highly polished stainless steel piston. The motor (linear
actuator) has a resolution of …/step.

Sealing between the syringe and the piston is ensured by a spring with rubber sealing surface.

page 91 / 106
Sampling valve

The MIX chamber is fixed to the Sampling valve (marked by white arrow).

WARNING
Risk of personal injury. The ceramic shear valve has a sharp needle installed. Avoid
touching the needle
Disconnect tubes and cables. Remove screws (2 screws) securing the sampling valve to the bottom plate
of the analyzer. Pull out the sampling valve towards the right side of the analyzer.

ATTENTION
The SAMPLING valve with the stepper motor and washing head is one module and
needs precise position adjustments. Please DO NOT DISASSEMBLE the sampling valve
module. In case of malfunction, please return it to the manifacturer for repair.

page 92 / 106
Closed Wash head cleaning
There are two levels to this problem:
1: you can hear cracking noise during sampling, and everything (sampling) works OK
2: you hear this cracking noise during sampling and you receive an error about “Not enough Blood…”

Reason:
The stainless plate (with hole in the center for the needle) on the black thing MUST slide easily on the
white part (teflon). By sliding and moving down it will push the wash head aside.
“Bang” (rather repeating cracking noise from the stepper motor) comes because the wash head (teflon)
cannot easily slide out and down from below the steel plate.

Solution:
IF there is blood/salt on the bottom of the steel plate, then it becomes sticky, and the teflon piece cannot
slide off. Clean the bottom of the steel plate and the top of the wash head. (Push down black thing with
hand, hold wash head by hand, release black part. Now you can clean both surfaces with a cotton swab)

If you receive “Not enough blood…” error, then it is very dirty, the tube gets blocked on the way down, and
the needle takes sample from the air or from the rubber plug of the sampling vial.

Clean the wash head and steel plate, and test it with your hand for easy movement.

Teflon is smooth enough, no greasing is required.

page 93 / 106
Sample mixer
WARNING
Risk of personal injury. The ceramic shear valve installed beneath the sample mixer
has a sharp needle installed. Avoid touching the needle
First remove the sampling valve.

Disconnect tubes and cables. Carefully pull out the flexible sampling tip from its wash head. (See process
at removal of Top cover)

Remove screws securing the sample mixer to the vertical assembly plate of the analyzer (4 screws).
Pull out the sampling valve towards the right side of the analyzer.

ATTENTION
The SAMPLE MIXER is one module and needs precise position adjustments. Please DO
NOT DISASSEMBLE the sample mixer module. In case of malfunction, please return it
to the manufacturer for repair.

Open Wash head (flexible tip) adjustment

The open wash head is designed to clean the flexible tip after taking sample from an open vial.

The tip (flexible tube) is connected to the sampling valve. An optical (blood) detector is checking for the
presence of sample. The tip is guided through a plastic “arm” (green arrow) that guides the tip into its
“track” (blue arc). The tip then is guided through the open wash head (inside yellow circle).

The arm (and the tip) should come out in a very smooth way (yellow arrows). The arm has 4 positions:

page 94 / 106
- BACK: the sample rotor pushes it against the rear micro-switch during flushing the content of the
tip into the wash head. The PUMP must be ON during this process to avoid leakage of sample or
System Solution
- IN: the sample rotor is barely touching the rear micros-witch. This is the IDLE position of the tip.
- MOVING/UNKNOWN: the tip is either moving, or is in an intermediate position.
- OUT: the sample rotor pushes it against the rear micro-switch. This is the position for aspirating
the sample. The sample rotor HOLDS the tip in this position

page 95 / 106
There is one position that requires adjustment and verification. This is the BACK position. This can be
verified manually.

- Open the right side cover (the one with the start button)
- Icon must be off, sample motor in top position.
o To make sure it is in the top: power on ICON, when the menu is displayed: press and
hold the screen at any (e.g. black) area to reveal a second menu. Select “Eject”. This will
force ICON to reset the sample rotor.
o After this, simply pull out the power connector.
- With ICON off, (and sample rotor in “up” position (sample vial opening is on top) verify that you
can manually (carefully) push out the flexible tip (move the white part that holds the flexible tip)
- If it comes out OK, then inspect the flexible tip, whether it is kinked, broken, etc. anywhere.
- If it is OK, then move it back and forth to make sure the micro switches are activated (you can
hear them “click”).
- If you find it all OK, then later on you can power on Icon and verify flexible tip arm operation
from the Software (Service Menu)

Verify that the end of the tip is in the right position:

+: (system solution from mini injector) - : vacuum (pump)

- Move the white plastic arm to the rear position (switch triggered/pushed)
- Use a little water to wet the open washing head (yellow circle)
- The end of the tip should be visible in between the two nozzles(“OK”).
o If the tip is beyond the lower nozzle (case A), then the tip will lose some drops of liquid
(sample or system solution) during the washing process.
o If the tip is beyond the upper nozzle (case B), then the tip may “jump out” of the wash
head and can be damaged.

To move the tip in the arm: remove the 3 screws that hold the plexi-glass, and carefully move the tip in
the required direction. After adjustment, verify the position again.

page 96 / 106
Measuring block
The measuring block becomes accessible after removing the left side cover of the analyzer (3 screws on
the back plate).

The measuring block is covered by a shielding plate.

Remove two screws to remove the shied and to access the apertures. (The cable is secured with star-
washers for secure electronic contact). The aperture has a platinum electrode installed. This electrode
connects to a gold-plated socket on the amplifier board.

There are two apertures. The left side aperture is for RBC and PLT, the right side aperture is for the WBC
measurement.

Each aperture is fixed to the stand with one screw. The drip tub is located beneath the two apertures.

To access the amplifier board, the entire block needs to be removed.

Aperture probe voltage troubleshooting

- Probe voltage is reported extra low (15-25)
- This can be caused by
o Aperture (leaking, broken)
o Amplifier
o Processor board
o Cabling

Identify and locate the potentially faulty components

page 97 / 106
 - Open Icon’s left side (the side without the switch)
- Locate the measuring unit (apertures) (1)
- Remove shielding of apertures (2) (remove aperture shielding)
- Locate RBC aperture house (3)
- Locate DCENT (control, processor) board (4)
- Locate cable (flat cable) (5)
1
2
3
4
5

Check before moving on:

- Check that the flat cable is correctly installed on the amplifier board
o (accessible after removal of 2 screws fixing measuring module to the base plate)
o Image on next page…

- Look for presence or traces of liquid inside

page 98 / 106
 - If such traces are found, then please take a picture and send it to me.
- Do not stop the fault location, please continue it.

Search for location of fault

- Power on Icon, Start a measurement

- Disconnect flat cable from DCENT board

- Run a measurement (empty vial)

- Probe voltages should be reported low, but stable, typically: 0-6. In this Case: DCENT is OK

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 - Reconnect flat cable, Run a measurement
- Probe voltages should again be „wrong”: 15-25 (cable is OK)

- Remove RBC aperture from measuring block:

o Remove screw that holds aperture against measuring block
o Pull off the aperture, leave it in its place.
o Make sure that the platinum electrode does not contact its socket.
o The bottom tube should be in the waste tank to avoid spills during measurements.

- Run a measurement
- Probe voltages should be >800. If so, Amplifier is OK.

Here is the “matrix” to decide which component is wrong:

Aperture Cable ProbeV Fault at

ON ON LOW: 15-25 ?
ON OFF LOW: 15-25 DCENT
ON OFF 0-6 ??
OFF ON LOW: 15-25 AMPLIFIER
OFF ON >800 APERTURE

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Tubes

Each tube that is installed with a threaded connector

has a so-called FERRULE on it. A ferrule is a sealing
element that minimizes dead volume around the tube
and is compressed upon tightening of the threaded
connector.

A ferrule, once installed over a tube doesn’t need

replacement unless visible damage can be seen on the
ferrule itself (broken rings). A ferrule that can be
“rotated” along the longitudinal axis of the Teflon tube is
still sealing well enough.

Assembly process of a threaded connector equipped with a ferrule.

1. Make sure that the end of the Teflon tube is flat, cut at a right angle.
2. Put on the threaded connector with its conical opening facing the end of the Teflon tube
3. Put on the ferrule so that its flat end (“collar”) is facing the end of the Teflon tube.
4. Push the end of the tube into its threaded socket
5. Push the threaded connector AND the ferrule towards the threaded hole.
6. Start tightening the threaded connector, making sure to exert a static, yet gentle force on the
Teflon tube so that its flat end is continuously pushed against the bottom of the threaded hole.
7. During the tightening process, the threaded connector will be harder and harder to be twisted.
This is when the ferrule is being compressed over the Teflon tube.
8. When the twisting becomes very hard, then you reached the end of the thread, and the ferrule is
already installed over the Teflon tube.
9. You are done.

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Testing procedures

Management menu / Maintenance

Maintenance menu allows verification of mechanical components inside the analyzer.

Each mechanical component (valves, motors) of the analyzer is accessible and operable from this screen.

Actions available for an individual component become active and available upon tapping the symbol of
the component on the screen.

Display and Touch screen

The touch sensitive area is secured to the inside of the Plexiglas cover with durable glue tapes.

Do not remove the tape unless necessary (replacement of touch sensitive device).

When absolutely necessary, the tapes must be peeled off and new tapes must be applied. Prior to
installation of the new touch sensitive area, make sure that obstacles, dust is removed using an anti-
static cloth. Avoid scratching the inside of the Plexiglas cover, as it may result in visible scratches.
Scratches will not influence operation but will result in a reduced aesthetics of the user interface.

The touch sensitive device is connected to its controller board with a sensitive, ZIF flat cable. The cable
has a reinforced handle flap, however avoid extreme force when inserting the cable to its socket.

The display must be reinstalled by making sure that spacing between the touch sensitive surface and the
display is kept by using the spacing elements. Do not over tighten the securing screws to avoid damage
to the instrument’s cover elements.

Testing the Display

1. Connect all cables.
2. Power on the analyzer.
3. Verify that the backlight operates (a small light line at the bottom of the display)
4. Verify that image is displayed (startup screen, main menu)

Testing the Touch Sensitive Area

The system needs time to calibrate the capacitive touch sensitive surface. This may take up to 10
seconds, and the screen may seem non-responsive to your touches, gestures.

1. Touch random points of the screen

2. Each touch is acknowledged by a set of concentric circles at the location of the touch.
a. This feature may be disabled in the software.
b. To enable it, connect an external USB mouse and navigate to the relevant setting
c. Then try again
3. Observe that the acknowledgement symbols appear under your fingertips.
4. Test “hold” gesture.
5. Test “swipe” gesture.

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START button
1. Operation of the START button must be performed with the power connected.
2. Pressing the START button must initiate the power on cycle.
3. This is accompanied by the border of the START button displaying various colors.

Power board (SOURCE)

1. Operation of the SOURCE board must be performed with the power connected.
2. Pressing the START button must initiate the power on cycle.
3. The top ring of the power board (SOURCE) will display colors when the analyzer is preparing the
internal mechanics for operation.

Manual (flexible) sampling tip

1. With the right cover plate removed, you can observe operation.
2. Go to Management / Maintenance.
3. Initiate pushing out the sampling tip.
4. Initiate retracting the sample tip.

Closed sampling
1. With the right cover plate removed, you can observe operation.
2. Go to Management / Maintenance.
3. Start operation without a vial inserted.
a. The vial will be lowered then retuned.
b. The sample mixer should not move.
4. Start operation inserting a vial without cap.
a. The vial will be lowered then retuned.
b. The sample mixer should not move.
5. Insert a vial with a cap.
a. The mixing and piercing operation will be carried out.

Sample mixer
1. With the right cover plate removed, you can observe operation.
2. Go to Management / Maintenance.
3. Activate the Sample mixer verify movements.
a. You may need to insert an empty sampling vial to allow operation

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Shear / Sampling / Ceramic Valve
1. With the right cover plate removed, you can observe operation.
2. Go to Management / Maintenance.
3. Activate the shear valve initiate and verify movements.

Main Injector
1. With the left cover plate removed, you can observe operation.
2. Go to Management / Maintenance.
3. Activate the Main injector, initiate and verify movements.

Mini Injector
1. With the right cover plate removed, you can observe operation.
2. Go to Management / Maintenance.
3. Activate the Main injector, initiate and verify movements.

Valves
1. With the left cover plate removed, you can observe operation.
2. Go to Management / Maintenance.
3. Activate valves in question, initiate and verify operation (toggle on/off).

Pump
1. With both the right and left cover plates removed, you can observe operation.
2. Go to Management / Maintenance.
3. Activate the pump, initiate and verify operation (toggle on/off).

page 104 / 106

Recommended set of tools

Hex keys (1.0; 1.5;2.0;2.5;3.0 [mm])

preferred with a handle

Spanners (6mm, 10mm, 13mm)

Pliers

Cutter (for cutting tubes)

Tweezers

page 105 / 106

Change log

Version Change Sections Affected Date Edited by

1.0D Original version All 2013-11-27 CsMagyar
1.0E Spare part Part-numbers added Spare parts – pp36-37 2013-11-28 CsMagyar
SW version reference removed Front page – p1
1.0F High voltage symbol added to list of symbols P4 2013-12-05 CsMagyar
Battery and fuse replacement warning added P11, p18, p23
model NAME  model TYPE P2
High voltage parts to be serviced only when no power P4
Tubing diagram updated, 79 valves P21
1.1A Testing procedures added pp36-38 2013-12-06 CsMagyar
Consecutive sections moved (Spare parts) Pp36-37  pp39-40
Consecutive sections moved (Change log) Pp38  pp-41
1.1B Disassembly procedures added P37-39 2013-12-11 CsMagyar
Consecutive sections moved
1.1C Model types revised P2 2013-12-13 CsMagyar
1.1D Revision01 ALL 2014-03-13 CSMagyar
1.1e TODO LIST UPDATED ALL 2014-03-18 CSMagyar
TODO sections added
1.1E2 PptDocx; images added (component identification) 2014-03-19 CsMagyar
Service menu images updated
1.1F2 Images added / updated ALL 2014-04-25 CsMagyar
1.1F2a Consumption (diluent) corrected P11 2014-04-27 CsMagyar
1.1G Finetuning – service menu descriptions 2014-05-06 CsMagyar
1.1g2 Add sw upgrade, errors, disassembly processes 2014-05-08 CsMagyar
1.2a1 Add troubleshooting details, FCTRL pin descriptions, HGB … 2014-07-18 CsMagyar
removal, Recommended tools, Reorganize chapters
(Service, disassembly)
1.2a2 Technical flags added 2014-07-23 CsMagyar
Open wash head and tip adjustment added 2014-07-24 CsMagyar
Spare part list removed
1.2a3 Consumption: cleaner volumes added 2014-07-31 CsMagyar
1.2a4 Aperture troubleshooting 2014-08-25 CsMagyar
FCTRL boards replacement procedure
1.2a5 Service Menu – ClearLog page, info…, screens updated Pp46-51 2014-09-16 CsMagyar
Unstable voltage resolution additions P66
Big Injector syringe removal P87
Amplifier test limits added P47
1.2a6 Service password P45 2015-03-23 ATremmel,
Pictures, sensors information P46 JCsikós
Service tests P50
Service settings P51
ER mode settings P55
Update pictures P71
1.2A7 Approved changes 15-3-23 CsMagyar

***

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