Service Manual - KENZA 450 - V 01-2016

Device of In Vitro Diagnosis for analyses of Medical Biology (Clinical Chemistry)
Only for professional use - Respect the legislation in force
Conform to the Directive 98/79/CE
Code GMDN: 15165
The photographs contained in this manual have only an explanatory function; therefore, some non-functional
features may not correspond to the device in question.
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INTRODUCTION
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This automated clinical analyser is an IVD medical equipment for indoor use and is based on the
colorimetric and turbidimetric measurement. Its main application is expected to be colorimetric
measurement, clinical chemistry testing, immuno testing and urine testing in clinical laboratories of
public hospitals and private clinics.
Using this Manual
This manual is for qualified technical personnel, who participated in the training course on the
instrument and has the requisite qualifications to carry out maintenance, repair, replacement and
alignment, treated in the various chapters.
Conventions Used in this User Manual
This section describes the conventional symbols used in this manual:
This symbol alerts the user to the presence of dangerous tensions and not
isolated within the instrument (risk of electric shock)
This symbol indicates a caution. Cautions indicate that appropriate care or

action must be taken
This symbol alerts the fluids used are biological fluids to be treated with care by
wearing adequate protections
A ground connection is needed
Important notes
Explanatory notes
List of abbreviations
Cal Calibrator LLD Liquid Level Detection
COM Serial port n/a Not applicable
Dil Diluent OD Optical Density
e.g For example OS Operative System
Kenza 450 Kenza 450 TX QC Quality Control
GUI Graphical User Interface P2P Pin to Pin
ISE Ion Selective Electrode Ref. Reference
LED Light Emitting Diode SD Standard Deviation
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Primary safety precautions
You should read the following safety precautions carefully before operating the system. If the
system is not operated according to the following precautions, the manufacturer or provider cannot
be liable for any damage or injury that might result. This chapter provides instructions on:
– Safe Use of the System.
– Installation Environment Precautions.
– System Labels and Displays.
– BIOLABO Guarantee.
Preventing Electric Shocks

– All circuit boards and electromechanical parts distributed inside the instrument are powered
with low voltage. Avoid putting your fingers in the area around the power outlet and the power
wiring of the switching power supply
Moving parts while in operations

– Do not open any cover while in operation. If someone touch sample probe, reagent probe,
washing arm, sample tray, reagent tray and reaction tray, it may cause injury.
– Do not put your fingers or hands into any holes or openings.
– When replacing the photometer lamp, turn off the power switch and allow at least five minutes
for the lamp to cool down. Touching the lamp before it is cool might result in burning.
– Observe the precautions on the system labels and in this service manual.
Preventing Eye Injury

– Do not look directly into the photometer lamp or any of the barcode readers while the system
is powered on. Light entering your eyes directly from the photometer lamp or the beam of
light from the barcode reader might result in eye damage.
Treating Waste Liquids

– The waste liquids and mixtures might require special treatment before being discarded. This
system is designed to discard the concentrated waste liquids (mixtures) and washing waste
liquids (washing water) separately. For proper waste disposal, refer to relevant local
authority guidelines.
Preventing Infection
– To avoid infection, always wear personal protective clothing when handling samples,
performing maintenance and coming in contact with waste.
– If infectious substances come in contact with your skin, flush the area and seek medical
advice.
– Wipe off any spilled contaminant immediately from the system.
– If any of the reagents or samples are accidentally swallowed, seek medical advice.
Correct Handling of Reagents, Calibrators and Control Serums

– Strictly follow any safety instructions supplied with reagents, calibrators and control serums.
Refer to the reagent manufacturer for any questions concerning the safe handling of any
material to be used on this system.
– Prepare reagents in accordance with the manufacturer’s instructions for use, paying particular
attention to any reconstitution, mixing and pre-treatment instructions.
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Preventing Damage to other Equipment and Facilities
– This system should have an independent power connection so that it cannot interfere with
other important electrical laboratory devices.
Handling Specimens
– The quality of the sample placed on the BIOLABO system is of paramount importance and all
efforts should be made to ensure it is of the highest quality. Numerous pre-analytical variables
exist and these should be accounted for before interpretation of the final result.
– Typical samples used on the BIOLABO system include serum, plasma, and urine. Other fluids
might not be suitable for analysis and care should be taken before analysis.
– All samples should be handled as if potentially infectious and protective clothing should be
worn at all times.
– Serum and plasma samples should be separated from blood cells as soon as possible to
reduce the risk of adulteration. Prior to analysis, samples should be free from suspended
matter such as fibrin. Any abnormal optical characteristics such as lipemia, icterus or
hemolysis should be noted. Results from such samples should be interpreted after
consultation with the applicable reagents instructions for use. Care should be taken to ensure
that any anticoagulants or collection devices that employ a barrier are compatible with the test
reagent being employed.
– Urine samples should be collected into appropriate preservatives and any suspended matter
removed by centrifugation prior to analysis.
– All samples should be protected from evaporation, contamination and, where applicable, light
(i.e. for bilirubin determination) prior to analysis.
Electromagnetic Wave and Noise Precautions

– Do not locate this system near equipment that generates extreme levels of noise.
– Never use, in the immediate vicinity, medical equipment that might malfunction due to the
effect of the electromagnetic waves.
Replacing Parts
– Calibration of system reagents is required after replacement of key parts such as syringes or
probes.
– Only use detergents (Wash Solution, Cleaning Solution etc.) of the type specified in this
manual to ensure optimum system performance.
Use of Consumables
– Only use BIOLABO approved consumables to ensure optimum system performance.
Setting Analysis Parameters

– Before using the system for the first time, you must set parameters such as the reagent and
sample quantity. Enter these parameters from the Settings Sheet provided with reagents, to
ensure optimum system performance.
Planned Maintenance Routines

– Have a planned maintenance routine for this system and follow the guidelines contained in
Chapter 6, “Maintenance”. If this system is not maintained in accordance with these
instructions, then optimum system performance and safe operation cannot be guaranteed.
– Have a maintenance routine for the computer software and hardware. This must include
frequently backing up data that contains analysis parameters and results history.
– The computer hardware should be dedicated to running the system software only.
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Performing Important Checks at Analysis
– Ensure system maintenance is performed adequately and repeat it if necessary.
– Check the quality of purified water.
– Check the calibration for abnormality.
– Check the quality control data.
– Check the individual analysis results for flags.
– Check the syringes and tubing for leaks.
– Check the samples for contaminants (dust, fibrin, etc.).
– Check the quantity of each sample and that no bubbles are present.
Installation Environment Precautions

It is very important to be aware of installation requirements. This section describes:
– Installation Environment. See chapter 2.
– Installation Space Requirements. See chapter 2.
Installation Environment
– Is located indoors and never more than 2000 m above sea level.
– Is not exposed to direct sunlight.
– Is clean and clear of dust.
– Has a flat floor that can support approximately 100 kg and is free of vibration.
– Has good ventilation. This system produces heat while operating.
– Has a temperature of between 18 and 32°C.
– During analysis. Air conditioning should be used if these conditions do not exist naturally, to
ensure optimum system performance.
– Has a humidity of between 40 and 80% RH, with no condensation.
System Labels and Displays

– The name of the instrument, power supply voltage, serial number and other information
regarding the KENZA 450 are shown on a label attached in the back.
BIOLABO warranty on product
The instrument is under warranty for 12 months from the date of shipment by BIOLABO.
The warranty will be cancelled in case of non-respect of use, cleaning, and maintenance
instructions, or in case of improper use of the instrument.
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T ABLE DES MATIERES
1. System configuration ................................................................................................................................. 10
1.1 Readout system ................................................................................................................................. 11
1.2 Photometer module ............................................................................................................................ 12
1.3 Readout cuvettes ............................................................................................................................... 12
1.4 Robotic system ................................................................................................................................... 13
1.5 Sampling arm ..................................................................................................................................... 13
1.6 Sample tray ........................................................................................................................................ 13
1.7 Reagent trays ..................................................................................................................................... 13
1.8 Washing arm ...................................................................................................................................... 13
1.9 Control system................................................................................................................................... 14
1.10 Block Diagram .................................................................................................................................... 15
1.11 Hardware error messages .................................................................................................................. 15
1.12 Interface board .................................................................................................................................. 16
1.13 ADC board .......................................................................................................................................... 17
1.14 Motor driver boards .......................................................................................................................... 17
1.15 Temperature & Level sensor control board ........................................................................................ 17
1.16 Power supply unit ............................................................................................................................... 18
1.17 Hydraulic system ................................................................................................................................ 18
1.18 Hydraulic Diagram ............................................................................................................................. 20
1.19 Technical specifications ..................................................................................................................... 21
2 Installation ................................................................................................................................................. 22
2.1 Unpacking .......................................................................................................................................... 23
2.2 Selecting a suitable location .............................................................................................................. 24
2.2.1 Installation environment ........................................................................................................... 25
2.2.2 Electrical requirements ............................................................................................................. 25
2.3 Preparation of the instrument .......................................................................................................... 26
2.3.1 Fluid connections....................................................................................................................... 27
2.3.2 Connection to the electrical outlet............................................................................................ 27
2.3.3 Connecting the computer.......................................................................................................... 28
2.3.4 Software installation.................................................................................................................. 28
2.4 Switching on the Kenza 450 TX.......................................................................................................... 28
3 Electronic Boards ....................................................................................................................................... 33
3.1 Interface Pcb...................................................................................................................................... 34
3.2 ADC Pcb ............................................................................................................................................. 35
3.3 Motor 1 Pcb ....................................................................................................................................... 36
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3.4 Motor 2 Pcb ....................................................................................................................................... 36
3.5 Motor 3 Pcb ....................................................................................................................................... 37
3.6 Temperature & level sensor Pcb ....................................................................................................... 38
4 Maintenance.............................................................................................................................................. 39
4.1 Preventive maintenance.................................................................................................................... 40
4.2 Removing the shell and lifting the work plan .................................................................................... 41
4.3 Checking the power supply ............................................................................................................... 43
4.4 Check of blowers ............................................................................................................................... 43
4.5 Mechanical settings ........................................................................................................................... 43
4.6 Replacement of needle and cleaner.................................................................................................. 45
4.7 Replacing the syringe glass and piston .............................................................................................. 45
4.8 Checking the accuracy of dispensed volume..................................................................................... 46
4.9 Cleaning and lubrication of mechanics ............................................................................................. 47
4.10 Check of the level sensor ................................................................................................................... 48
4.11 Washing System ................................................................................................................................ 49
4.12 Replacing the dryer stump ................................................................................................................ 50
4.13 Cleaning and check of the drain wells ............................................................................................... 50
4.14 Replacing the Readout cuvettes ......................................................................................................... 51
4.15 Replacing the lamp ............................................................................................................................. 51
4.16 Check and adjustments of the photometric reading ........................................................................ 52
4.17 Check and adjustments of temperature ........................................................................................... 53
4.18 Scheduled replacement ..................................................................................................................... 53
4.19 Replacements and Adjustments ........................................................................................................ 54
4.19.1 Replacing the Photodiode Pre-amplifier board ......................................................................... 54
4.19.2 Replacing the bearings of the filter wheel .................................................................................... 56
4.19.3 Lamp power supply adjustment ............................................................................................... 56
4.19.4 Adjusting the height of the needle ............................................................................................ 57
4.19.5 Cuvette positioning ................................................................................................................... 58
4.19.6 Adjustment of the washing arm ................................................................................................ 58
5 Parts Identification .................................................................................................................................... 60
6 Communication Protocol........................................................................................................................... 69
6.1 How to transmit and receive ............................................................................................................. 76
6.1.1 Communication controlled by the user ..................................................................................... 76
7 Table of Flags ............................................................................................................................................. 79
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Kenza 450 System Configuration- 1
1. S YSTEM CONFIGURATION
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Kenza 450 TX is an automatic analyser with microprocessor control, for clinical chemistry
and immunoturbidimetry analysis, available in the table-top version. The “Random Access”
operation mode allows rapidly running all the tests on a patient and printing the report,
without having to wait the routine to be completed. Moreover, you can add new patients,
even with STAT priority, whilst running the tests and, if necessary, repeat calibrations.
KENZA 450 TX analyser has been designed to achieve a throughput of 420 tests/hour.
The graphical interface has been designed to make all the functions of this appliance
simple and intuitive, as well as to provide flexibility as required by every laboratory. KENZA
450 TX is composed of the parts described in the following page.
1.1 Readout system

This system is composed of a photometer equipped with a rotor containing a set of
interference filters; an optical fiber connection and of a carousel containing 50 plastic
optical cuvettes. It is also equipped with an automatic optical cuvette washing-rinsing and
drying station for their next use.
The interference filters are installed on a rotor, which turns at a constant speed during the
readout, thanks to a DC motor. At the photometer outlet, a series of monochromatic
pulses are transmitted via the optical fiber connection to the cuvette carousel, where the
rays of light pass through each optical cuvette. It is important to notice that each cuvette
is crossed by a series of monochromatic light pulses, which allows measuring
transmittance at various wavelengths. These measurements are then selected
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according to the test parameters.

Once the transmitted light reaches the solid-state detector located on the opposite side
of the selected cuvette, it is converted into an electrical signal, which is then amplified
and sent to the A/D Conversion circuit.
1.2 Photometer module

The Kenza 450 TX photometer provides a series of light pulses with different
wavelengths, thanks to a rotor onto which are installed a set of interference filters. The
used light source is a halogen quartz lamp powered at 5.8 V. The produced light is
concentrated into a converging beam by a convex and plain-convex lenses unit and
passes through the filters, which turn at a constant speed; the train of light pulses is then
transmitted to the reading cuvettes via an optical fiber. The rotation of the filter carousel
occurs by means of a DC motor, while the rotation control and the synchronization for the
readout of every single filter are obtained via two pulse signals that result from the
passage of the specially shaped filter wheel through a pair of optical couplers.
The photometer is composed of the following components:
– A halogen quartz lamp with an adjusted and stabilized power supply, which emits light
in the visible, UV and near Infrared regions.
– A filter wheel that contains a set of 9 narrow band interference filters. By continuously
rotating during the readout, this filter carousel emits a train of monochromatic light
pulses. This way, it is possible to have a readout of the cuvettes with all the available
wavelengths. Moreover, the continuous rotation of the filter carousel allows dissipating
the heat absorbed by each filter, thus increasing their average life. The rotation phase
and speed are electronically controlled.
The wheel contains the following interference filters:
Position Nm Position Nm Position Nm

2 340 5 546 8 380
3 405 6 570 9 450
4 505 7 620 10 700
The position 1 of the filters wheel is closed to prevent the passage of the light
and measure the output voltage of the amplifier (offset) in the absence of signal
1.3 Readout cuvettes

The train of light pulses deriving from the photometer is transmitted to the readout
cuvette tray via an optical fiber. This rotating tray contains 50 plastic cuvettes with a 0.6
cm optical path, in which chemical reactions occur, after which the readout of the
absorbance related to the intensity of the colors developed during the reactions is
performed. A resistive system with electronic temperature control heats the air around
the cuvette tray, so that the induced temperature stabilizes the cuvette temperature at
37°C. The rotating movement of the loader is due to a stepper motor with a 360° rotation.
When in idle state, the cuvette tray is positioned so that cuvette 21 is in front of the ray of
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light.
1.4 Robotic system

The Kenza 450 TX robotic system involves all the mechanical parts related to fluid
sampling operations and to the placement of the reagents and samples necessary for
running the tests. The readout module is also integral part of this system.
1.5 Sampling arm

KENZA 450 TX is an instrument that operates in SIP & DIP mode; therefore, it uses
one single sampling arm for the aspiration and dispensing of the sample and reagent.
The arm is equipped with two bipolar stepper motors and it can move vertically as well
as rotating by 320° in order to place itself on samples, internal and external reagents,
on the readout cuvettes and on the drain and washing sump. The arm is also provided
with a capacitive level detector for detecting reagents and samples.
When the level detector does not detect any sample, the appliance emits a sound to
warn the operator that the sample is insufficient or missing.
1.6 Sample tray

The sample tray can operate in two different configurations. The tray contains 80
samples that can be arranged in 2 ml secondary cups or in primary tubes of size 75-100
mm / 12-13 mm. In both cases there are 8 further positions available for calibrators and
10 positions for control sera. Thanks to a bipolar stepper motor, the tray rotates
clockwise and anticlockwise by 360° and it moves for a preset number of steps, starting
from the reference position indicated by a photo-coupler and a flag. A barcode reader
optional detects the samples arranged in the primary tubes. The tray can be removed
from its housing by loosening the two fixing knobs.
1.7 Reagent trays

The reagent trays are provided with 30 positions for the insertion of as many plastic
containers containing the reagents necessary for running the tests. There are two
different types of containers, the single ones, which can contain 60 ml of reagent, the
double ones with two separate compartments, which can contain 17 ml and 40 ml
respectively. There are two trays, one is reserved to the reagent 1 while the other is
reserved to the reagent 2 and 3 if provided. The trays are provided with a cooling
system, which is constantly in operation even when the instrument is turned off but is
however connected to the power inlet. The stepper motor and the movement control
system is the same as those used for the sample tray.
1.8 Washing arm

The washing arm is a device located on the side of the readout module, which only
performs a vertical movement thanks to a stepper motor. The movement control is
carried out via two photo-couplers that detect the two extreme positions “high” and “low”.
On the head of the washing arm there are some tubes for introducing and sucking the
washing water, as well as a Teflon pad for drying the cuvette.
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1.9 Control system

Most of the electronic control system KENZA 450 is located in the rear of the unit. The
electronic boards are inserted into a metal cage with various slots and can be
accessed by removing the panel at the rear of the instrument. The microcontrollers
that are on some electronic boards can be identified by a label bearing the
microcontroller number and the software version. Microcontroller 0 (PCB interface)
communicates with all the other microcontroller in a unidirectional manner, since it can
require performing robotic movements or activating solenoid valves and suction
pumps. Only with micro 5 there is a bidirectional communication. For an easy
identification of these devices, please see the following table, which shows the
microcontrollers on each board and the associated command functions.
µ- Assembly Chip µ- Assembly Chip

contr. contr.
Motor 1 920126 (PN00045-4) Motor 2 920127 (PN00045-4)
µ1 Cuvettes carousel U7 µ6 Sample tray U7
µ2 R1 arm horizontal U14 µ7 R1 tray U14
µ3 R1 arm vertical U13 µ8 R1-R2 barcode U13
reader
µ4 R1 dilutor + valve U12 µ9 Sample dilutor + U12
valve
µ13 Washing arm U6 µ10 Washing dilutor + U6
valve
Motor 3 920128 (PN00045-4) ADC 920125 (PN0085-1)

µ11 Not used U7 µ5 ADC + filter motor U3
µ15 R2 arm horizontal U14
µ14 R2 arm vertical U13 Interface 920119 (PN 0083-1)
µ12 R2 dilutor + valve U12 µ0 Interface U12
µ16 R2 tray U6 µ17 ISE management U15
Temperature & level sensor 920131

(PN0075-1)
µSL Level sensor + antishock U4
R1-R2
Hereafter are the microcontrollers programmed with the same software revision:
µ4, µ9, µ10, µ12;
µ2, µ15;
µ3, µ14;
µ7, µ16
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1.10 Block Diagram
1.11 Hardware error messages

Micro 0 constantly communicates unidirectionally with the other microcontrollers. Only with micro 5 of
the ADC board the communication is bidirectional. If a robotic movement fails due to a mechanical
problem or electronic or accidental nature, you receive a message indicating the microcontroller
involved and the type of movement failed. It is a generic message that does not specify the primary
cause of the failure.
µC Movement Error Description

µ0 1 Computer cannot communicate with µController 0
µ1 1 µController 0 cannot communicate with µController 1 / Cuvettes Carousel
motor does not rotate or cannot find its home position
µ2 1 µController 0 cannot communicate with µController 2 / Horizontal Sampling
Arm R1 motor does not rotate or cannot find its home position
µ3 1 µController 0 cannot communicate with µController 3 / Vertical Sampling
µ4 1 µController 0 cannot communicate with µController 4 / Diluter R1 motor
does not rotate or cannot find its home position
µ5 1 µController 0 cannot communicate with µController 5 to activate or
deactivate the filters wheel
µ6 1 µController 0 cannot communicate with µController 6 / Samples Tray motor
µ7 1 µController 0 cannot communicate with µController 7 / Reagents Tray R1
µ8 1 µController 0 cannot communicate with µController 8 / Reagents Barcode
reader motor does not rotate or cannot find its home position
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µ9 1 µController 0 cannot communicate with µController 9 / Diluter Samples

µ10 1 µController 0 cannot communicate with µController 10 / Washing Diluter
µ12 1 µController 0 cannot communicate with µController 12 / Diluter R2 motor
µ13 1 µController 0 cannot communicate with µController 13 / Washing Arm
µ14 1 µController 0 cannot communicate with µController 14 / Vertical Sampling
µ15 1 µController 0 cannot communicate with µController 15 / Horizontal
Sampling Arm R2 motor does not rotate or cannot find its home position
µ16 1 µController 0 cannot communicate with µController 16 / Reagents Tray R2
µ3 2 µController 0 cannot communicate with µController 3 or cannot receive the
steps detected with the level detector R1
µ4 2 µController 0 cannot communicate with µController 4 for activation or
deactivation of diluter R1 valve
µ5 2 µController 0 cannot receive or transmit commands related to ADC from/to
µController 5
deactivation of samples diluter valve
deactivation of washing valve
deactivation of R2 diluter valve
µ13 2 µController 0 cannot communicate with µController 13 / Washing Arm
motor does not rotate or cannot find its lower position
µ14 2 µController 0 cannot communicate with µController 14 or cannot receive
the steps detected with the level detector R2
µ0 2 Computer cannot communicate with µController 0 or to read/write data on
EEPROM
µ0 3 Computer cannot communicate with µController 0 or transmit / receive data
to/from Barcode reader
1.12 Interface board

This board is used for interfacing the instrument with an external management computer.
The instrument operates by means of three different managing software. The first and
highest level is represented by the Windows management software, which includes
the user interface. This software communicates through the serial port with the
interface board, which decodes the various instructions via an intermediate software
and manages the robotic movements and the cycle that controls the processes of the
instrument. The lowest level software is represented by the firmware configured in the
microcontrollers which provide to the direct management of the electro-mechanical
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parts and of each stepper motor. Micro 0 located on the Interface board directly
controls some solenoid valves, the suction pump, the drain sump and the vacuum
pump. Upon switching the instrument on, the management software receives all the
settings regarding the positioning of the robotic assemblies, as well as the various pre-
set functions stored in an EEprom of the interface board. The screen will briefly show the
data reception and then the main menu will appear. In case some of the settings have
not been carried out, the screen image below will appear, with the list of all the
instrument’s settings: those already made and those yet to be done.
1.13 ADC board

This board allows amplifying the electric signal coming from the photodiode pre-
amplifier located in the readout module and converting the analogue signal in a digital
one, which will be processed by the external management software.
The amplifier rest current gain level and offset level adjustments, as well as the filter
carousel motor rotation speed adjustment are carried out on this board. Moreover, this
board also houses some solenoid valve and discharge pump drivers.
1.14 Motor driver boards

There are three motor control boards onto which the microcontrollers and the stepper
motor drivers are installed. These boards use two PBL 3717 bipolar motor drivers for
each motor. Each board is provided with a quartz oscillator circuit for producing the
clock signal, which is necessary for a correct microcontroller operation. The control of
each robotic movement takes place by means of one or more optical sensors that
generate an impulsive signal with voltage levels between zero (LLL) and 5 volts (HLL).
The receipt or less of these signals by the microcontroller, confirm the success or
failure of the robotic movement. In case of failure the microcontroller warns micro zero
which in turn generates a message of alert. The message indicates which
microcontroller has had communication problems with micro zero therefore according
to the table above it is easy to know which is the robotic movement that has not been
successful. The indication given is very general because it does not specify what
caused the malfunction. In fact the cause of a malfunction robot can be many, because
there are several mechanical and electronic elements involved. It is up to the
technician to find out the cause and resolve it.
1.15 Temperature & Level sensor control board

This board includes all the electronic circuits that control the temperature in the various
sections of the instrument. The control system used is always based on the same
circuit configuration i.e., an operational amplifier with a reference threshold connected
to a temperature detection device. The control actuation systems, on the other hand,
vary according to the used heating or cooling elements. The board also includes a
microcontroller that has to oversee the functioning of the level sensor of the two
needles responsible for the aspiration of the reagents and the sample. This feature
also allows to measure the volume of reagent, present within each container. The
same microcontroller also controls the function anti-shock in case one of the two
needles bangs against a hard surface.
Parts of the instrument where there is the temperature control, are described below:
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– A circuit controls the temperature of the readout module, i.e., of the cuvettes; in
this case, an electrical resistance powered with 30V AC is also used as a heating
element. A safety thermostat, incorporated with the heater, interrupts the electrical
current in the event of excess temperature (70 °C).
– Another part of the circuit controls the cooling system of the reagent trays; in this case,
a Peltier cell cools a metal tray onto which the reagent vials are arranged.
– Part of the electronic system controls the reagent pre-heating. Also in this case, a Peltier
cell, in contact with a round support where the Teflon tube is wrapped, heats the reagent
during the sampling phase.
1.16 Power supply unit

The power supply unit is located under the electronic boards rack and it is composed of
one toroidal transformer, one switching power supply and one conventional stabilized
power supply. The latter through the secondary AC voltages provided by the
transformer, supplies the necessary voltage for powering the photometer lamp.
Transformer also supplies the 30V AC for the heating of the cuvettes and two AC
voltages for the Photodiode Amplifier. A section of the switching power supply is always
in operation once the power cable is connected, providing the +24V DC voltage for the
operation of the cooling modules, the ISE module and of some fans. The other sections
of the switching power supply provides the +5V, +12V, -12V, +24V DC voltages for all
the other parts of the instrument.
1.17 Hydraulic system

The hydraulic diagram of the Kenza 450 TX can be subdivided into three functional
areas:
– sampling of sample and reagents
– washing of cuvettes
– drain of washing liquids
Sampling of sample and reagents

The sampling system is based on three dilution modules, one for the sample and the
other two for reagent 1 and 2. Each one is equipped with a syringe of 1000 µL (500µL
for sample) powered by bipolar stepper motors, one solenoid valve installed onto the
module itself and a pre-heating device installed on the sampling arm (common for R1
and sample). Each sampling system operates in SIP & DIP mode. The sampling arm
places itself on the required reagent and the sampling probe lowers itself to withdraw
the established volume of reagent. The probe then rises up, while the arm rotates and
places itself on the sample tray in correspondence of the sample to be analysed. The
probe lowers itself and withdraws the established volume of the sample and then it
rises up again. Once this stage has been completed, the sampling arm rotates and
places itself on the readout carousel in the dispensing position. The probe descends
in the cuvette and dispenses the sample with the reagent. In this phase the mixing
between sample and R1 occurs naturally during dispensing.
Instead, if the use of a second and third reagent is preset, the sampling arm R2
withdraws the established volume of reagent and dispenses it into the same cuvette
containing R1+S. In the latter case, the overall mixing takes place by aspirating partly
the volume and then dispense it again into the cuvette. To start the chemical reaction
only inside of the cuvette, the sucked liquids are separated by gaps of air.
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The pre-heaters located on the sampling arms, raises the temperature of the reagents
up to approximately 30°C, thus allowing the sample-reagent mixture to quickly reach
37°C.
Washing and drain of liquids

After each sampling cycle, a cleaning system washes the external surface of the
sampling probes with a mixture of water and air, preventing any contamination of the
next sampling. The water flowing through the cleaner of the needle is driven by means
of one of the diaphragm pumps. For the same purpose, cycles of Prime driven from
the syringes, rinse the inner surface of the needles and the tubes of Teflon. The
washing water is in turn discharged into the washing wells. Two solenoid valves that
connect the well to the membrane pump allow its emptying.
Washing of cuvettes
The readout cuvettes are washed by means of a mechanical arm that, when lowered,
introduces some double needles in the cuvettes to fill them with water and then to
empty them. The filling phase of the cuvettes takes place by sucking water from the
tank by means of three syringes in PVC moved up and down by a single stepper motor,
inside a plexiglass body. With the action of three solenoid valves, the water is
dispensed into cuvettes and then sucked by means of two double body-diaphragm
pumps and discharged into the waste bottle. While the first three needles fill and
empty, the fourth needle must only drain and therefore prepare the cuvette for the final
drying. Instead, the first action taken by the first needle, is to empty the biological fluid
from the cuvette. At the choice of the user, this liquid is directed to a separate exhaust
line to be adequately treated. A specially shaped Teflon pad, connected to the vacuum
pump, dries the cuvettes that have been washed.
Service Manual 19
1.18 Hydraulic Diagram
Service Manual 20
1.19 Technical specifications

Operation principle Random Access
Readout mode OD optical density
STAT Function Possible entry of urgent samples at any time
Type of analysis End Point, Linear Regression for Kinetic reaction, Initial Rate (2 points Kinetic),
Bichromatic Reactions. Differential Reactions (with Sample Blank).
Type of calculation Factor, calibration curve
Sample tray 80 positions for samples cups and primary tubes 12-13mm x 75-100mm, barcode
identification available upon request, 8 positions for standards, 10 positions for controls,
Each position can house a STAT sample.
Reagent tray 1 tray for R1, 1 tray for R2-R3. Both trays are refrigerated. 30 positions for single reagent
(60mL) or double reagent (17mL+40mL); 60 positions for single reagents (double
container); optional adaptor for 5mL tube or Hitachi cup 2mL
Readout carousel 50 optical cuvettes (0.6 mm optical path). 5 steps automatic washing station.
Temperature controlled at 37°C +0.5°c -0°C
Optical System Photometer with 9 Interferences from 340 to 700nm (340-380-405-450-505-546-570-620-

700) bandwidth +/- 2nm with filters 340 and 380 and +/- 10nm with the remaining filters.
Linear Absorbance from 0.0005 Abs to 3.000 Abs
Throughput Max. 420 tests/hour; +480 tests/hour with ISE
Sampling system SIP & DIP sampling with capacitive level detector. Reagent pre-heating; Sampling
accuracy 1% for 1µl steps.
Connectivity External printer A4 size; RS232 serial port for connection to LIS
User interface Indication on Display regarding the sample loading list. Troubleshooting diagnostic
system.
Help on Line
Sample volume 2-100µL
External tanks Distilled water, waste liquids, cleaning solution
Operating Working temperature from 15° to 32°. Relative humidity Max. 70% at 32%
environment
Power supply Voltage 115/230 AC+/- 6% 240 AC upon request Frequency 50/60Hz Power 450 VA
Dimensions and 105(L)x 77(D) x 58 (H)cm-90 Kg

weight
Options Barcode reader for sample tubes and reagent containers
Service Manual 21
Kenza 450 Installation- 2
2 I NSTALLATION
Service Manual 22
The step of installation is extremely important as compliance with the rules and requirements listed
below, contributes to the optimal functioning of the analyser in the time. The main rules to be observed
are as follows:
– Selecting a suitable location
– Suitable environmental conditions
– Compliance with the electrical requirements
– Computer with appropriate features
– Windows operating system since Windows XP
2.1 Unpacking
The image below shows the packing of the Kenza 450 TX. Before unpacking the instrument check
the state of the crate and the impact indicator. Notify the carrier of any physical damage. If the
packaging is intact go ahead with the procedure of unpacking.
It is important to store the shipping crate of the instrument in anticipation of a future

displacement or to return the instrument in case of repair.
1. Remove all the clips used to close

the case by levering with a
screwdriver.
2. Remove the cover and lift the

protective material of the
instrument.
Service Manual 23
3. Raise the exterior wooden crate

with care.
4. The analyser is ready to be
installed. Reassemble the packing
crate and keep it for future use.
5. Check the equipment received
against the packing list enclosed
to ensure that the shipment is
complete. If the shipment appears
to be incomplete, notify your
distributor immediately.
2.2 Selecting a suitable location

The following figure shows the size of the Kenza 450 TX:
To ensure proper operation, put the Kenza 450 TX in a place that meets the following requirements:
 The bench must be vibration free and able to support the weight of the instrument, computer, LCD
display and printer (approximately 100 Kg). The space requirements will vary depending on the
configuration of the Kenza 450 TX and components. In fact the graphical interface of the Kenza
450 TX has been conceived for using a LCD display equipped with touch screen. The useful space
needed for positioning on a desk the Kenza 450 TX and other devices like computer, monitor and
printer, is shown in the drawing below:
Service Manual 24
 It is recommended to leave the space suggested at the sides and below the unit to allow proper
ventilation.
 The environment must be as free as possible from dust, mechanical vibrations, loud noises
and electrical interference.
 Avoid proximity to brush-type motors, flickering fluorescent lights and electrical contacts that
regularly open and close.
 Avoid placing the instrument in direct sunlight or in front of a source of heat or drafts.
2.2.1 Installation environment

 For indoors use only
 Operating temperature 18°C to 32°C or (64.4°F to 89.6°F)
 Maximum relative humidity at 70% for temperature up to 32°C (87.8°F)
2.2.2 Electrical requirements

For proper operation and to obtain reliable results are essential the following electrical requirements:
 A properly grounded outlet supplying 200-240 V or 100-120 V, 50 to 60 Hz.
 Maximum fluctuation of voltage not exceeding 6% of the nominal value.
 The power outlet must be free of interfering electrical noise (less than 0.5V neutral to ground).
 It is recommended to connect the Kenza 450 TX to a dedicated line.
 In areas where the power network suffers frequent power outages, it is recommended the use
of an opportunely sized UPS equipment.
Service Manual 25
2.3 Preparation of the instrument
As a precaution, to avoid damage during transport, some moving parts of the instrument
are locked with screws and carefully shaped material that hinders their mobility. Follow
the instructions hereinafter to restore the operating conditions of the instrument.
 Remove the screw that blocks the

vertical movement of the arm.
 Open slightly the two parts of the cover,

pay attention to not force the screw
fixing the two parts. Place it from the
top and move it vertically. Help the
entry of both cable and tube.
 Put in the 4 screws supplied and

tighten by an Allen wrench of 2 mm.
Service Manual 26
2.3.1 Fluid connections
 Connect tubes and electrical connector
of the waste sensor (the shortest) to the
opportune inlets.
of the water to the opportune inlets. Fill
the container, previously rinsed, with
distilled water.
of the cleaning solution to the
opportune inlets.
 In case of use of a separate container
for biological liquids, connect the tube
and the electric connector to inlets
dedicated.
2.3.2 Connection to the electrical outlet

Connect the serial port of the Kenza 450 TX to the COM port of the computer with the serial cable
supplied.
The analyser is shipped with the voltage selector set to 200-240V. Change the setting if
the main voltage of your country is 110 AC V.
Connect the Kenza 450 TX to the power inlet with the power cable supplied.
If the power cable does not conform to local standards, replace it with one having the
same characteristics.
As soon as the power cord is connected to the power inlet, we can hear the noise due
to the fan of the cooling system independently from the status of the power switch.
Service Manual 27
2.3.3 Connecting the computer
For this procedure, it is assumed that Windows is already installed on the computer and all updates
were made. The same applies for the printer and for the touch screen if provided.
It is strongly recommended to disable the options to save energy that disable the hard drive
after a period of keyboard inactivity. It is recommended to disable the screen saver and turn
off the antivirus software.
Any computer with standard features can be used to control the Kenza 450 TX. The presence of at
least a serial port to connect the instrument to the computer and a CD reader to install the instrument’s
software is indispensable. The computer must be equipped with two serial ports in case the instrument
is connected to a LIS. All Windows OS, starting from Windows XP, are compatible with the instrument.
– Connect the serial port of the Kenza 450 to the serial port of the computer using the serial
cable P2P supplied.
– Connect the LCD display, keyboard, mouse and printer to the computer.
– Connect all the equipments to the power inlet.
2.3.4 Software installation

– Turn on the external computer and wait for the loading of Windows.
– Insert the CD with the software of the Kenza 450 into the CD reader. The CD is self-
installing therefore follow the instructions appearing on the monitor otherwise make double
click on “setup.exe”.
– For your convenience, create a shortcut on the desktop with the icon of the Kenza 450's
program.
2.4 Switching on the Kenza 450 TX

– Double click on the Kenza 450 TX icon then turn on the power switch and confirm with
Enter.
– The screen displays the following picture:
– The operator can select the automatic search of COM port (Search) or enter directly which
is the COM port connected to the Kenza 450 (manual selection).
Service Manual 28
– Start the receipt of mechanical settings stored inside the analyser.
– Reset of all robotic assemblies is carried out successfully.
If during the initialization, one or more settings are missing, a red screen with the list of
the settings to be performed is displayed.
The red screen is a warning for the user that is going to use the analyser. Make reference
to the Maintenance chapter and to the User Manual to perform the settings required.
Kenza 450 TX is shipped with all settings made and stored in an EEPROM of the
instrument.
Click the button Continue to set the main screen hereinafter shown.
Service Manual 29
The Kenza 450’s software was developed in a way which is simple and user friendly. This feature
minimizes the learning time and allows the user to use the analyser immediately. Every screen offers
different options which can be selected directly via left-click of the mouse or a touch of your finger.
Not casually, the GUI has been conceived expressly to favor the use of a touch screen. In the main
screen are easily identifiable:
– The two trays for the reagents and the carousel sample holder.
– The legend of the colors characterizes with specific color the type of reagent and sample,
diluent and cleaning solution of the ISE.
– The reagents within each tray, are marked with their code and the internal volume is indicated
by the color red if the reagent is insufficient for the tests pre-set. The blue, yellow and purple,
with a dual color intensity, respectively indicate the volume of R1, R2 and R3. The dual tone
indicates the volume level content.
– The numbering of the slots of the reagents tray is from 1 to 60. You can load 30 containers of
type C in the positions 1-30 or 30 double containers of type A and B in positions 1-60.
– The position 30 is reserved for the cleaning of the ISE (if present) while the position 60 to the
diluent used for the pre and post dilutions of samples.
Service Manual 30
– The carousel of samples hosts in the two outer rings 80 cups or primary tubes. Inside there
are two areas of different color: the blue one reserved for calibrators (8 positions) and the
green reserved for controls (10 positions).
– The bar at the top of the screen, besides the name of the producer and the user, displays the
software revision in use.
– Just below another bar displays the time and the current date (computer data), the COM port
of the computer connected and the "i" button that when clicked, displays information about
each software release issued. Furthermore, in the left part of the bar are visible messages
that warn the operator of an occurred condition that prevents the proper functioning of the
analyser and therefore requires operator intervention.
– At the bottom, is visible the bar with the buttons more frequently used.
– At the far right is visible a floating bar that when clicked shows a series of buttons used less
frequently.
– Finally there are the buttons "Calibration" and "Patient Entry" that lead directly to the screen
where you can set the calibrations and the one where you set up the patients.
To complete the installation you must execute the following steps:
 Restore the file with the most common assays that is stored in the archive. To do this step,
follow the procedure How to restore the file "Met4500.arc".
 Insert the reagent bottles in the slots of the two trays refrigerated.
 Execute a washing cycle of the cuvettes with the solutions IPO and Extra cleaning. To do this
step, follow the procedure How to wash the cuvettes.
How to restore the file "Met4500.arc
– Click Methods/Methods/Archive
– Double click on the folder "Methods"
– Double click on the folder "met4500"
– Click the file "Met4500.arc"
– Click the button "Restore", a message warns
that the methods in use will be replaced, click
Enter
– Click the Exit button to return to the grid of the
methods
Service Manual 31
After restoring the file "Met4500.arc" the two trays of the reagents appear as in the figure
 Load the container R1 of each pack in the assigned slot of the tray R1.
 Load the container R2 and R3 of each pack in the assigned slot of the tray R2.
How to wash the cuvettes
– From the main screen open the floating

bar.
– Click Washing / Ipo+Extra.
– It opens a window that asks you to
verify if the two solutions are at the
positions reserved for them.
Fill the two special containers with the solutions IPO and Extra. The washing cycle uses
25mL of each solution. Containers and solutions are provided with the instrument.
– Click the Enter key and the image

beside is displayed.
– The washing process will last around
20 minutes.
The installation phase is completed and the Kenza 450 is ready to start working.
Service Manual 32
Kenza 450 Electronic Boards- 3
3 E LECTRONIC B OARDS
Service Manual 33
This chapter contains information on the electronic boards used in the instrument and the functions
performed by each. The figure below shows the cage containing the electronic boards and their
placement. The card cage is accessible by removing the rear panel.
Each board is identified by a reference code that takes into account the electronic components and
of the printed circuit (layer). Boards with the same layer but with different components or different
programming of microcontrollers assume a different reference code.
3.1 Interface Pcb
Ref. 920119 - layer PN 0083-1
Item Ref. Adjustment Note
µ0 U12 Interface control
µ17 U15 Control of ISE and sample barcode

EEPROM U13 Stores the instrument settings
Potentiometer P1 7V Voltage reference for stepper motors
Potentiometer P2 9,6 V Voltage reference for stepper motors
Potentiometer P3 10,6 V Voltage reference for stepper motors
Service Manual 34
3.2 ADC Pcb
Ref. 920125 - layer PN 0085-1
Item Ref. Adjustment Note

Controls the rotation of the filter wheel and the digital
µ5 U3
processing of the photometric signal
Potentiometer P1 4.0-8.5 V Photometer Gain
Potentiometer P4 0.002-0.006 V Photometer Offset
V
Potentiometer P8 15 V Supply voltage of the photodiode Pcb
Potentiometer P6 -15 V Supply voltage of the photodiode Pcb
Potentiometer P10 35 ms Speed of the filter wheel
Relay RL Provides the voltage to the motor of the filter wheel
U17-U18-U26- Activate the needles valves, valves of diluters,
Drivers
U27-U28 vacuum pump
Service Manual 35
3.3 Motor 1 Pcb
Ref. 920126 - layer PN 0087-1
Item Ref. Assembly controlled Note
µ1 U7 Cuvettes carousel L5 optical sensor signaling
µ2 U14 R1+S arm rotation L4 optical sensor signaling
µ3 U13 R1+S arm vertical L3 optical sensor signaling
µ4 U12 R1 dilutor and electrovalve L2 optical sensor signaling
µ13 U6 Washing arm L1 optical sensor signaling

Jumper JP3-JP6-JP10-JP13- 7 V (VR0) provide the ref. voltage to drivers of
JP16 motors
Jumper JP2-JP5-JP9-JP12- 9,6 V (VR1) provide the ref. voltage to drivers of
JP15 motors
Jumper JP1-JP4-JP8-JP11- 10.6 V (VR2) provide the ref. voltage to drivers of
JP14 motors
3.4 Motor 2 Pcb

Same figure of Motor 1
Ref. 920127 - layer PN 0087-1
µ6 U7 Samples tray L5 optical sensor signaling
µ7 U14 R1 tray L4 optical sensor signaling
Barcode reader of
µ8 U13 L3 optical sensor signaling
reagents
Service Manual 36
µ9 U12 Sample dilutor and valve L2 optical sensor signaling
Washing dilutor and

µ10 U6 L1 optical sensor signaling
valves
JP16 motors
JP15 motors
JP14 motors
3.5 Motor 3 Pcb

Same figure of motor 1
Ref. 920128 - layer PN 0087-1

µ11 U7 Not used
µ15 U14 R2 arm rotation L4 optical sensor signaling
µ14 U13 R2 arm vertical L3 optical sensor signaling
µ12 U12 R2 dilutor and valve L2 optical sensor signaling
µ16 U6 R2 tray L1 optical sensor signaling
JP16 motors
JP15 motors
JP14 motors
Service Manual 37
3.6 Temperature & level sensor Pcb
Ref. 920131 - layer PN 0075-1
3.7
Item Ref. Control / regulation Led Note
µSL U4 Level sensor + shock sensor

L1-
Potentiometer P1 Temperature of preheater R1
L2
L3-
Potentiometer P2 Temperature of preheater R2
L4
Level sensor for needles R1 and
Potentiometer P3 Sensitivity adjustment
R2
Potenziometer P4 Not used
Potenziometer P5 Cooling temperature R2-R3 L9
cooling
Potenziometer P6 L8 Not used
Potenziometer P8 Temp. cuvettes carousel L11
Potenziometer P9 Cooling temperature R1 L10
Led L5 Level sensor R1 signaling level detected
Led Level sensor R2 signaling level detected

L6
Led L7 Not Used
Led L12 Not used
Led L13 Impact sensor R2 Signaling impact detected
Led L14 Impact sensor R1 Signaling impact detected
Service Manual 38
Kenza 450 Maintenance- 4
4 M AINTENANCE
Service Manual 39
This section describes the various preventive and corrective maintenance operations for the optimal
operation of the analyser. The table at the end of this chapter includes a list of spare parts subject to
wear, which must be replaced periodically. The diagnostic routines available to the maintenance
technician allow carrying out the following operations:
– Ordinary maintenance interventions for keeping the instrument efficient.

– Stimulating and controlling the movements of the mechanical parts in case of malfunction.
– Mechanical and electronic adjustments following the replacement or removal of a mechanical
unit or of an electronic device.
4.1 Preventive maintenance

On average, it is recommended to perform preventive maintenance on the automatic analyser Kenza
450 TX every 6 months. This time frame is merely indicative, as it is strongly linked to the daily
workload supported by the instrument. At the discretion of the technical assistance, depending on the
stress undergone by the instrument, the distance in time between a PM and the next may be shorter.
The following table indicates the sequence of operations of control and maintenance, to be performed
with the instrument switched off and switched on in order to optimize the working time. Most of the
operations to be performed are detailed and accompanied with images.
Functionality Operation Action

Operations to be performed with the instrument OFF
General Visual inspection – Visually inspect inside the instrument to check

for leakage
Cleaning and lubrication of
Mechanical
Diluters, arms R1-R2, washing – Clean and lubricate the worm screw and the
assemblies sliding axes
arm
– Pull out one board at a time and clean the
Electronic boards Cleaning electrical contacts with a cloth moistened with
alcohol
Sampling system Replacement – Replacing the needle and cleaner (arm R1-R2)
Washing system Replacement – Replacing the stump
Reading system Replacement – Replacing the photometer lamp
Service Manual 40
Functionality Operation Action

Operations to be performed with the instrument ON
Ventilation Check – Checking the efficiency of each fan
– Measuring the voltages supplied by the switching
Power supply Voltage measurement power supply
– Measuring the lamp voltage
Electronic
– Checking the reference voltages on the Interface
Voltage measurement Pcb
boards
– Checking the ±15 V on the ADC Pcb
Needles alignments – Performing the mechanical settings
Sampling Check volume

– Checking the accuracy of the volume dispensed
system – Replacing the syringe
Level sensor
– Grounding of samples and reagents trays
– Check of the rest voltage
Alignment – Mechanical alignment of the washing station
Check the efficiency of the
Washing system washing – Perform a cycle of washing with water
Cleaning and Check of the drain
wells – Washing with hypochlorite and check of drainage
Replacement of the cuvettes – Replace the ring with the cuvettes

Cleaning of cuvettes – Execute a washing cycle with Ipo+Extra
Photometric reading and – Check the range and reproducibility of photometric
Reading system adjustments reading
– Speed adjustment
– Gain and offset regulation
– Equalization of filters
– Check cuvettes temperature
Temperature Check temperature and adjust – Check preheaters temperature
– Check cooling temperature of reagents trays
4.2 Removing the shell and lifting the work plan
Removing the shell
– Remove the shells which cover the two arms R1 and

R2
– Remove the 10 screws that secure the shell of the
instrument to the metal frame
Service Manual 41
– In front of the instrument, a hole in the bottom allows
disconnect the cable connecting the safety switch
– Lift the shell
– To operate with the instrument it is necessary to

simulate the connection with the safety switch. Use a
specially wired connector such as that shown in the
picture beside, otherwise provide a short circuit
between the two pins connecting the safety switch
Lifting the work plane
– Remove the samples tray A

– If you want to overturn the worktop, remove the
Screws that secure the work surface to the 3 spacers
shown in the figure (A-B-D) and the screws on the
sides (C)
– Separate the air vent shown in the figure from the
frame
– Lift the worktop from the back and lock it with the two
rods
Service Manual 42
4.3 Checking the power supply
– Once the work plan has been lifted it is easy

to access the power supplies of the
instrument
– The power supply consists of 5 sections that
provide the following stabilized voltages:
 +24 V ± 0.3 V (Cooling and ISE)
 + 24 V ± 0.3 V (Stepper motors)
 +12 V ± 0.2 V (Electronic circuits)
 -12 V ± 0.2 V (Analogic circuits)
 +5 V ± 0.2 V (Digital circuits)
– The section that provides 24 V to the
refrigeration system and to ISE, is active
regardless of the state of the power switch
4.4 Check of blowers
– Check the efficiency of the built-in fans within

the cooling modules
– Check the efficiency of the fan cooling the
power supply zone
– Check the efficiency of the cooling fans
integral parts of the Temperature & level
sensor Pcb
– Check the efficiency of the cooling fan lamp,
underlying the photometer assembly
4.5 Mechanical settings

Allow the centering horizontal and height adjustment of the needles in the various positions
assumed during the process of analysis. Perform the following steps:
Centering of needles
You can choose to make all the alignments in sequential form, or only that selected
– access the service menu, then click the button "Set Step" to display the following screen
Service Manual 43
– Open the drop-down menu shown in the figure and click the option "All Adjustments"
– Perform the centering of the needle in the various positions aligning with the two buttons "Plus"
and "Minus". Click Save to store each adjustment.
Rise from sample
– Click the "Ck Up Movement" and control the

portion of needle that stays out of the cleaner
– If necessary vary the steps up to meet the
required adjustment
– Change of steps is stored automatically
Descent on sample
– Place an empty sample cup in the position

S1 of the sample tray
– Click the button "Check Down Movement"
and control the gap of air between the tip of
the needle and the bottom of the cup
– If necessary change the steps up to meet the
required adjustment
– Change of steps is stored automatically
– Fill the cup with 150 µL of any reagent after
that click again the button "Check Down
Movement"
– This time the needle stops below the liquid
surface and the display appears the image
of the cup partially yellowed to simulate the
presence of serum. The test confirms the
correct functioning of the level sensor
Service Manual 44
4.6 Replacement of needle and cleaner
You must verify the integrity of the needle and the total absence of curves and humps. The two
components are tightly bound and it is often necessary to replace both. In fact, if the needle as a
result of an accidental bump bends, also damages the washer. The cleaner is equipped with a small
gasket that ensures the sliding of the needle and the hydraulic seal of the assembly. The loss of
sealing is cause of dripping of water
Replacement of the cleaner

– Loosen the Hallen screw by an hexagonal
key
– Pull down the cleaner after which disengage
from the tubes of water inlet and outlet
– Replace with the new spare part but replace
the needle before reposition the cleaner
Replacement of the needle

– The figure shows the interior of the
preheater and the position of the needle
inserted in the tube of Teflon
– Remove the hex nut fixing the needle to the
preheater
– Pull down the needle cannula
– Insert the new needle cannula gently
pushing it up to the upper limit
– Screw the hex nut with your fingers as much
as possible. Gently screw an additional 1/4
turn with the hex key
4.7 Replacing the syringe glass and piston
– Use the diagnostic routine to lower the dilutor piston

– Select the diluter and introduce a number of appropriate
steps (800 steps)
Service Manual 45
– Loosen the screws (detail 3) and push the piston (detail
1) upwards to disconnect it from the bracket.
– Remove the anchor (detail 2) and the syringe rotating the
upper metal part (detail 4) counterclockwise.
– Remove the Teflon seal from the syringe housing in the
Plexiglas unit (detail 5) using a pointed tool.
– Install a new Teflon seal.
– Insert a new piston in a new syringe dipping its tip in
distilled water to make the movement more fluid, then
screw the syringe and the piston back on in the housing
in the plexiglas unit (detail 5) (pay the most attention to
the inclination of the syringe, since the piston must center
the fixing collar without being forced (detail 3).
– Manually lower the syringe piston (detail 1) until it enters
in the bracket.
– Carry out a mechanical reset of the dilutor.
– Manually push the piston downwards and then upwards,
up to touch the manifold in plexiglass with the tip of the
piston.
– Tighten the screw that fixes the piston to the bracket
(detail 3)
Pay attention when tightening the screw; an excessive force could break the head of the
screw
– Put back the anchor (detail 2)

– to verify the correct filling of the syringe, the absence of air bubbles and water losses, run a few
cycles of Prime
4.8 Checking the accuracy of dispensed volume

It serves to verify the accuracy of the volume dispensed from syringes. If the accuracy of the volume
is ascertained, it says the proper functioning of all the elements involved as a syringe, valve, manifold,
plexiglass, tubes, preheater and needle. To perform the test, you need a 10-20 mL graduated cylinder
or a graduated tube with an equal volume. Perform the following steps:
Service Manual 46
– remove the preheater from the arm R1
– access the screen Service and click the
button "Prime"
– access the screen "Set Steps" and uncheck
the button "Double Diluter" (disable the
sample diluter)
– back to the screen "Service" then click
"Prime"
– put the needle tip in the graduated container
– select R1 then enter 5 cycles
– repeat again the previous step
– the measured volume within the container
must be approximately 10 ml (each cycle is
equivalent to 999 µL
– to test the syringe that sucks the sample
reactivate the button "Double Diluter"
– repeat the double sequence of primer (each
cycle dispenses 1500 µL)
– the measured volume within the container
must be approximately 15 ml
– Repeat the procedure for testing the syringe
dispensing R2 and R3
4.9 Cleaning and lubrication of mechanics
Diluter of reagents and sample
– Clean the worm screw and the axis of

support with a cloth soaked with alcohol.
Lubricate the two metal parts with a drop of
lubricating oil specific for mechanical gears.
Do not use grease or other substances that
can slow the movement
Service Manual 47
Washing Arm
– Clean the sliding axes with a cloth soaked

with alcohol. Lubricate the two metal parts
with a drop of lubricating oil specific for
mechanical gears. Do not use grease or
other substances that can slow the
movement
Sampling Arms
– Clean the sliding axes with a cloth soaked

with alcohol. Lubricate the two metal parts
with a drop of lubricating oil specific for
mechanical gears. Do not use grease or
other substances that can slow the
movement
4.10 Check of the level sensor

The two needles aspiring the reagents and the sample, are able to detect the presence of the liquid
within the various containers. The change in capacitance between the needle and ground, is the
function used to determine the presence of the fluid. The electronics that controls the function is
placed either within the preheater as well in the board Temperature & Level Sensor. As preventive
maintenance, perform the following steps:
– The metal blade shown in the figure is the

connection element between the needle
and the electronic circuit. As the area
where is the electrical contact is exposed
to splashing of reagent or sample, keep
contact cleaned with a cloth soaked in
alcohol
Service Manual 48
– in stand-by, the measured voltage on the
blue wire (signal of the level sensor), must
be greater than 1 V
– measure the resistance of the tray against
ground
4.11 Washing System

Washing system plays an important role because its low efficiency affects the accuracy and
reproducibility of the results. The system must ensure the cleanliness of the following elements:
– inner and outer surfaces of the needles
– sampling tubes
– reaction and reading cuvettes
Outer and inner cleaning of needles

Internal cleaning of needles and tubes is realized through the flow of water controlled by the syringe.
The cleaning of the outer surface of the needle is ensured by the hydraulic seal of the cleaner and
the recirculation of the water inside it. Replace the cleaner on time according to the table of preventive
maintenance and check the correct water circulation through the use of diagnostics:
– access the screen "Service" to check the

correct water circulation
– "Probe Wash" section contains the
commands that let you turn on the aspiration
pump and switch the solenoid valves in
order to activate the flow of water inside the
washer
Cleaning and drying of the cuvettes

The washing station is composed of a mechanical arm that moves a support with 4 needles and a
dryer stump, between the position of stand-by (upper position) and the activation position (down
position). The first needle is single and has the task of emptying the cuvette from its biological content
sample-reagent and then fill it with water. The others are 3 twin needles that have to empty and fill
the cuvettes with water. The dryer stump of PVC must push the residual water towards the bottom of
the cuvette then sucked by the vacuum pump. The best way to verify the efficiency of the washing
system of the cuvettes is to perform a cycle of washing with water after which remove the cuvettes
from the housing to verify cleaning and drying.
Service Manual 49
– open the floating bar and click the button "Washing then H2O
(the process lasts approximately 10 minutes)
– during the washing process, check if there is overflow of water
– at the end of the process, remove the four screws shown in the
figure after which raise the support ring of the cuvettes
– Verify the cleaning and the drying of the cuvettes.
– The presence of water droplets on the walls of the cuvettes
indicates poor efficiency of the washing system. The possible
reasons may be
– The presence of water droplets on the walls of the cuvettes indicates poor efficiency of the
washing system. The possible reasons may be the following:
 poor alignment of the block needles + dryer stump (see par. 4.19.6)
 loss of efficiency of the dryer stump due to edges rounded or blackening of PVC
 Loss of efficiency of the vacuum pump
4.12 Replacing the dryer stump

– loosen the two screws indicated by the arrows
– pull up the dryer stump, replace it with the spare and reinsert
it into the slot
– align the washing station (see par. 4.19.6)
4.13 Cleaning and check of the drain wells

It is a preventive action in order to verify the operation of the drainage and prevent the obstruction of
the exhaust pipe.
– filling the wells with diluted sodium hypochlorite

at 2 % and let stand for 5 minutes
Service Manual 50
– access the screen "Service" and select "Waste /
Probe Wash. Pump ON" in "Probe Wash" section
– the activation of the drain pumps must quickly
empty the wells
4.14 Replacing the Readout cuvettes

This operation should be carried out every six months or every 40,000 tests. To
replace the readout cuvettes, proceed as follows:
– Remove the readout tray cover and move the sampling arm
so that it does not obstruct the removal of the cuvette
carousel.
– To remove the readout carousel, loosen the 4 fixing screws
(red arrows) in the center and lift with caution. When
removing, make sure that the carousel does not come into
contact with the washing system probes.
– Insert a new carousel with the relative cuvettes inside the
container and fix the four screws beck on. Make sure that
each cuvette is completely lowered and fixed to the plastic
wheel.
– Make sure that the carousel can rotate freely before putting
the cover back on.
– Carry out the readout of the filters to verify readout reproducibility and range.
Carry out a few washing cycles with Ipocleaning and Extracleaning solutions to
degrease the newly installed cuvettes thus preventing the formation of micro air
bubbles.
4.15 Replacing the lamp

– Disconnect the lamp Faston plugs from the power socket.
– Remove the 3 fixing screws on the lamp and remove it from
its housing.
– Insert a new lamp, avoiding to modify the bulb alignment and to
touch it with your fingers.
– Reinsert the 3 fixing screws.
– Connect the lamp Faston plugs to the power socket.
– Carry out the readout of the filters to verify readout
reproducibility and range.
Service Manual 51
If during the lamp replacement you accidently touch the lamp bulb with your fingers,
remove any impurity with acetone or ethyl alcohol.
4.16 Check and adjustments of the photometric reading

Allows to verify the value, stability and reproducibility of the photometric signal to the various
wavelengths
Before performing the check, be sure that the lamp is ON for at least 5 minutes and the
cuvettes have been washed with the two solutions Ipo and Extra
– access the screen "Service" and select

"Reading ADC"
– the Kenza 450 asks the cuvette to be
checked after which fills it with about 500 µL
of water and places it in front of the light beam
(usually cuvette 1 is selected)
– the picture shows the following data:
 Filters: the photometric readings at
different wavelength, converted to
digital and expressed in Volt.
 offset: is the output voltage of the
amplifier in the absence of the light
signal expressed in Volt
 Speed: is the speed of rotation of the
filter wheel expressed in ms
Range of the filters reading

– The range, which ensures the correct operation of the photometric system is 4 to 8.5 V. By adjusting
the gain of the signal, you may raise or lower the voltage value of all filters. If necessary, adjust with
P1 of the ADC board
Stability of reading
– Check the stability of the photometric reading, normally only the least two significant digits vary
continuously
Reproducibility of reading
– Repeat the ADC reading 3 times, each time selecting the same cuvette. Verify the reproducibility of
the displayed readings
Offset
– The reading range, which ensures the correct operation of the photometric system is 0,002 - 0,006.
If necessary, adjust with P4 of the ADC board
Speed of the filters wheel
– The speed of rotation of the filter wheel is 35 ms ± 0.1 ms. If necessary, adjust with P10 of the ADC
board
Service Manual 52
4.17 Check and adjustments of temperature
The temperature of the cuvette compartment, where the chemical reaction takes place, significantly
affects the result of some types of tests. The temperature of the reagents trays, determines the greater
or lesser stability of the reagent once on board of the instrument. Keep in mind that the temperature
measurements reported hereinafter, are influenced by the room temperature that in principle should
measure between 18°C and 24°C degrees
Cuvettes temperature
– remove the cover of the cuvette
– fill six cuvettes equidistant with 500 mL of distilled water
– put back the cover of the cuvettes
– be sure that the graphic displays the main screen (with this screen the cuvette carousel rotates
continuously favoring uniform heating of the cuvettes)
– Wait 20 minutes and then access the Service menu to stop the carousel and measure the
temperature of the water contained in the six cuvettes. The measured temperature has to be 37°C
+ 0.5 / -0.5°C
– If necessary, adjust the temperature with P8 of the board Temperature & Level Sensor. It is
advisable to turn the potentiometer with steps of 1/4 of turn allowing to the cuvettes to reach the
new temperature set. Turning clockwise the temperature increases
Preheater Temperature
– remove the cover of the cuvettes
– simulate the acceptance of 5 patients with a test each (it is advisable to select a test that uses a
single reagent)
– be ready to emerge the temperature probe into the cuvette where the reagent is dispensed
– the measured temperature has to be approximately between 29°C and 32°C
– If necessary, adjust the temperature with P1 (pre-heater R1) and P2 (pre-heater R2) of the board
Temperature & Level Sensor. Turning clockwise the temperature increases
Cooling Temperature
– remove the reagent tray

– Pour a few milliliters of water in the area
between the 4 screws shown in the figure
(the 4 screws securing the cooling module
below to the metal surface)
– wait 5 minutes before placing the
temperature probe in the water
– the measured temperature has to be
approximately between 1°C and 2°C -0°C
/ + 1.5°C
– if necessary, adjust the temperature with
P9 (tray R1) and P5 (tray R2) of the board
Temperature & Level Sensor. Turning
clockwise the temperature decrease
4.18 Scheduled replacement

The table summarizes the items subject to wear with the reference code and scheduled time for
replacement. Some of the items listed are used in multiple assemblies. Replacement is required for
all elements of the same kind
Service Manual 53
Preventive Maintenance
Check, adjustment and replacement Ref. 6 months 1 year
Replacement of the cuvettes 13-0055 √ √
Replacement of the photometer Lamp 13-0003 √
Replacement of the Syringe glass + piston 001542 √
Replacement of the syringe seal M000135 √
Replacement of the Probe cleaner MA000140 √ √
Replacement of the sampling probe 3-0021 √ √
Replacement of the Dryer stump 13-0052 √
4.19 Replacements and Adjustments

This chapter describes the procedures of replacement and adjustment of components and assemblies
normally not required by the operations of preventive maintenance.
4.19.1 Replacing the Photodiode Pre-amplifier board
The Photodiode Pre-amplifier board is located inside the readout carousel

in correspondence with the optical fiber. Usually, it does not need to be
replaced; however, an overflow from the cuvettes could damage the circuit.
Since the replacement requires time, to make sure that the board is really
faulty, carry out the following verifications:
Carry out an ADC readout and if the voltages appear unstable or equal to
0V, find out if the problem depends on the ADC system or is caused by the photodiode Pcb. This
verification can be made by connecting the positive pole of a 1.5V standard battery to the blue wire
and the negative pole to the brown wire of the connector shown in the figure.
This connector is part of the cabling and connects the photodiode board to the ADC board. It is located
in the lower compartment under the readout unit. The total absence or the instability of the signal
despite the insertion of the battery indicates a malfunction of the ADC board. If, on the other hand,
the fault is due to the photodiode pre-amplifier board, the filter readouts would have all equal value
and be stable; therefore, the fault that was pointed out would disappear. To access the photodiode
pre-amplifier board, proceed as follows:
– Turn the amplifier off, disconnect the power supply cable and
remove the external cover.
– Remove the optical fiber from its housing by loosening the fixing
grub screw on the cylindrical support (fig.1).
Service Manual 54
– Remove the four screws that fix the readout unit to the metal base
of the instrument.
– Lift the unit and disconnect the ground connection cable together
with the connectors of the optocoupler, Photodiode board and of
the heating element.
– Remove the eight screws that fix the cover of the cuvettes housing
and remove both the cuvettes and the cover.
– Remove the collar and the cylindrical support of the optical fiber.
– Remove the three screws that fix the external band to the base of
the readout unit and remove the band.
– Remove the three fixing screws and carefully lift the heating ring.
For an easier movement, remove the cabling fixing the band.
– Remove the two fixing screws and remove the photodiode

preamplifier board.
– Insert the photodiode of the new board in its housing, making sure
that the surface of the photodiode is clean. If necessary, use a soft
cloth to clean the surface.
– Reassemble the readout module, repeating the previous actions
in reverse order.
– Carry out the checks and adjustments required for following this
replacement. For this purpose, please refer to the Replacements
& Adjustments flow chart in Chapter. 4.19.4.
Service Manual 55
4.19.2 Replacing the bearings of the filter wheel
– Turn the instrument off and disconnect the power cable

– Remove the external cover
– Remove the 4 screws that fix the photometer to the frame
– Remove the two optical sensors
– Disconnect the motor, remove the lamp connection terminal
and the ground connection (yellow arrows)
– Once free, lay the photometer on the table
– Remove the 3 screws that fix the motor to the unit
– Remove the 4 screws that fix the optical section to the

assembly
– Remove the fan and the filter wheel cover
– Remove the screw that fixes the filter wheel by locking the
rotation axis with a screwdriver
– Extract the filter wheel, the rotation axis, the two bearings and
the spacer in this order
– Replace the faulted bearings with new ones of the same type
and reassemble the photometer by carrying out the same
operations in reverse order
– With the replacement of the bearings, we recommend
checking and, if necessary, replace the filters wheel motor
– Once the bearings have been replaced, carry out the checks
4.19.3 Lamp power
and adjustments supply
as in adjustment
paragraph ?
–
– To adjust the lamp voltage, connect the two voltmeter probes
in parallel to the lamp wires. Adjust the voltage by turning the
potentiometer shown in the picture.
– All adjustments must comply with the specifications below
Service Manual 56
Board Test Point Specificatio

PCB 920080 Lamp connector ns ±
+ 5.8V
P1 0.2V
4.19.4 Adjusting the height of the needle
– Disconnect the power cord and remove the external cover of

the instrument; lift the worktop and fix it with its special rods
– Turn the instrument
– The figure at the side shows the part below the work plane of
the sampling arm. When in idle state, the position of the needle
in the cleaner is determined by the position of the flag (1) locked
to the transmission belt. The early or late arrival of the flag
within the optical sensor (2), determines the position of the
needle in the cleaner
There are 24V in the board containing the optical detector and the solderings to the
robotic cable therefore it is advisable the maximum attention to prevent short circuits
Service Manual 57
– Loosen the two locking screws and move the flag up or down
to lift or to lower the sampling probe
– Tighten the flag screws and carry out a mechanical reset.
– After each adjustment, do a reset mechanic before assessing
the position of the needle
– Make sure that the position of the needle in the cleaner meets
the specifications shown in the figure. If not, repeat the
alignment procedure
4.19.5 Cuvette positioning
– The top right part of the mechanical set-up menu allows the
aligning of the cuvette in front of the light beam. Should the
number of steps inside the box be modified, the position of the
cuvette will change as well. The alignment consists in the
centering of the cuvette in front of the light beam produced by
the photometer and brought into place through the optical fiber
(red arrow). The two screws used to fix the fiber and its support
(yellow arrows) can be taken as a reference, or you can carry
out a direct visual check of the cuvette through the optical fiber
duct.
The different alignment of the cell requires the revision of the alignment of the washing
station.
4.19.6 Adjustment of the washing arm

The alignment of the washing arm is to adjust the vertical position of the stump and its centering inside
the cuvette. The vertical alignment is achieved when the arm comes down and the stump lightly
touches the bottom of the cuvette. Instead, the horizontal centering is achieved if the shape of the
stump is equidistant from the four walls of the cuvette. The optimal centering allows the push toward
the bottom of the residual water adhering to the walls.
Service Manual 58
Vertical Adjustment
– Remove the washing arm cover and loosen the 2 fixing screws
of the dryer stump (1)
– remove the piston and replace it with the spare
– once the stump is replaced, it is necessary to adjust the height
and centering the stump into the cuvette
– tighten the two screws as much as needed to prevent the fall
of the stump but such to allow the vertical movement
– lower the washing arm by hand allowing the entering of the
stump into the cuvette
– reset the mechanic then lower the arm using the software
routines
– push the stump down to ascertain that just skims the bottom of
the cuvette and then tighten the two screws
– make sure that when the stump is going to skim the bottom of
the cuvette, the three needles (2) lift approximately of a few
millimeters. It is a detail that confirms the correct adjustment
Horizontal Adjustment
– Lower the arm up to stop the stump to the top of the cuvette in
order to verify if it is perfectly centered
– if you need to make an adjustment, loosen the screws (3)
securing the block containing the needles and stump
– move the block up to center the stump and the needles inside
the respective cuvette then tighten the screws
– once tightened the screws recheck the adjustment. During the
descent the stump must center the the cuvette without the
– perform
slightest atouch
cycle of washing with water and at end of the cycle remove the ring of the cuvettes
from its housing to check the perfect drying
Service Manual 59
Kenza 450 Parts Identification- 5
5 P ARTS I DENTIFICATION
Service Manual 60
3 1 4 1
4 2
Part Ref. Description Note

1 MA000151 Sampling arm
2 MA000164 Samples Tray for tubes 12x100 +
tubes 12x75 + cups
3 MA000014 Dilutor assembly

4 22-0005 Preheater + antishock
Service Manual 61
Below the working plane
5 8 8 7 6 9 6
6 7

5 13-0033 Vacuum pump
6 13-0071 Samples tray; reagents tray (R1-R2);
cuvettes carousel; dilutors
7 22-0029 Sampling arm horizontal movement (R1-
R2)
8 13-0029 Sampling arm (R1-R2) vertical
movement
9 19-0004 Cooling assembly
Service Manual 62
12
14
15
16
17
10
11 13 10
00
10 13-0049 Membrane pump double body
11 001501 Barcode reader
12 13-0070 SMC electrovalve
13 M001678 Washing manifold in plexiglass
14 M001437 Diluter manifold in plexiglass
15 Syringe glass + piston 500 µL
16 001542 Syringe glass + piston 1000 µL
17 M001679 Piston for washing dilutor
Service Manual 63
18 2 21
18 19 1 20
9 0
1
18 000921 Optocoupler one hole fixing
19 000922 Optocoupler 90°
20 001128 Belt of sampling arm Vertical movement
21 22-0014 Robotic cable
Service Manual 64
22 23 24 25 26 27 28 29

22 M001593 Waste well
23 13-0052 Dryer stump assembly
24 MA000140 Needle cleaner
25 22-0026 Sampling needle
26 13-0003 Lamp
27 22-0010 Photometer assembly
28 13-0004 Filters wheel motor
29 000998 Optical fiber
Service Manual 65
40 39 38
31 30 32 33 34 35 36 37

30 000966 Filters wheel bearing
31 19-0015 24 V fan
32 OEM000124 Filter 700 nm
33 000116 Filter 340 nm
34 000117 Filter 405 nm
35 000119 Filter 505 nm
36 000120 Filter 546 nm
37 000121 Filter 570 nm
38 000128 Filter 620 nm
39 OEM000725 Filter 380 nm
40 000900 Filter 450 nm
Service Manual 66
41

41 11-0027 SMC electrovalve
47
43 44 45 46

43 001299 Toroidal transformer
44 920112 Lamp power supply
45 001482 +5V, +12 V, -12 V, +24 V switching power
supply
46 001004 Power socket + fuseholder + mains filter
47 000751 110-240 voltage selector
Service Manual 67
48 49 50
51 52 53

48 920126 Motor drive 1 Pcb
51 920119 Interface Pcb
52 920125 ADC Pcb
53 920131 Temperature & level sensor Pcb
Service Manual 68
Kenza 450 Communication Protocol- 6
6 C OMMUNICATION P ROTOCOL
Service Manual 69
The computer which controls the Kenza 450 analyser, can establish a bidirectional connection with
an external computer. You can choose two modalities for the data exchange:
Use a connection RS232 (crossover wiring cable)
Use local path sharing (LAN connection)
COM port data transmission

In case of connection RS232, the Kenza 450’s PC needs at least 2 COM ports, the first one to control
the instrument, the second one to connect to the LIS
RS 232 Serial Data cable

The RS232 serial cable wiring has to match to the indications of the following diagram:
LIS COM port COM

(Laboratory Kenza 450
Interface 25 Analyser
9 pin 9 pin 25 pin
System) pin
3 2 Transmiss. /Receive 2 3
2 3 Receive /Transmiss. 3 2
5 7 Base 5 7
Com port setting

Baud
Data # bits Stop bit Parity bit Handshaking Input Len
Rate
Val. 19200 8 1 no 0 1
Protocol Data Layer

The protocol data link layer uses the following transmission control code
Transmission Transmission
Explanation
control code control code
(name)
<STX> 2(02h) Code to show the beginning of text.
<ETB> 23(17h) Code to show the interruption of text.
<ETX> 3(03h) Code to show the end of text
<ENQ> 5(05h) Enquiry
<ACK> 6(06h) Acknowledge
<NAK> 21(15h) Not acknowledge
<EOT> 4(04h) End of transmission
[FN] Frame number ASCII numbers from 0 to 7. The first frame begins with 1
[C1][C2] Checksum
Data String Description

Each string, either in reception or in transmission, is composed as follows:
STX data BCC ETX

Data are only ASCII printable characters included between ASCII 32 and 255. BCC is the two
character of lowered Hexadecimal notation for less significant 8 bits of the algebraic checksum of
all the characters of data string.
Data Transmission Flow
If LIS wants to send data to the Instrument, it must send the character ENQ. If the Instrument is in
Service Manual 70
reception mode, it responds with ACK, then LIS st ar t s t o send data strings.
Below is a receiving communication diagram (LIS - Instrument):
LIS Analyser Kenza 450
If the Instrument has to send results string to LIS, it must first send an ENQ to establish serial
connection. The LIS responds with ACK. Until ACK is not received, the instrument sends an ENQ
every 10 seconds until the timeout condition is reached. Below is a transmitting communication
diagram (Instrument – LIS):
LIS Analyser Kenza 450
String format
Below are the details relative to the construction of strings from/to the Instrument,
indicating name and length of fields making them up.
Separators are not utilized within data strings.
Service Manual 71
It is necessary to distinguish two cases on the basis of length of the field Pat.ID:
• 9 character Pat. ID:
When transmission is from LIS to Instrument the data to be use are the following:
i. Pat. ID: 9 char
ii. Patient name : 30 char
iii. Species (gender) : 32 char
iv. Test name : 3 char (for each test required)
When transmission is from Instrument to LIS the data to be use are the following:
i. Pat. ID: 9 char
iii. Species (gender) : 32 char
iv. Test name : 3 char (for each test required)
v. Test result : 9 char e.g. “1234.5678” (for each test required)
Data string format
Patients Data String (Lis  Instrument):
To be considered for the calculation of the BCC
Tests
<STX> Pat. ID Sample Name Species BCC <ETX>
Required
1 char 9 char 30 char 32 char 3 char 2 char 1 char
Up to 96 different tests
Tests Test
<STX> Pat. ID Sample Name Species BCC <ETX>
Required Result
1 char 9 char 30 char 32 char 3 char 9 char 2 char 1 char
8 character Pat. ID:
When transmission is from LIS to Instrument the data to be use are the following:
i. Pat. ID: 8 char
iii. Test name : 3 char (for each test required)
When transmission is from Instrument to LIS the data to be use are the following:
i. Pat. ID: 8 char
iii. Test name : 3 char (for each test required)
iv. Test result : 9 char e.g. “1234.5678” (for each test required)
Service Manual 72
Data string format
Patients Data String (LIS Instrument):
<STX> Sample ID Sample Name Requested BCC <ETX>

test
1 char 8 char 30 char 3 char 2 char 1 char
Results Data String (Instrument  LIS):
Requested Test
<STX> Sample ID Sample Name BCC <ETX>
test Result
1 char 8 char 30 3 char 9 char 2 char 1 char
char
No separator character is provided between the fields composing the strings. The result
is codified in the following format: xxxx.xxxx (9 characters including comma/period).
Example communication string

id 8 CHAR LIS  KENZA 450
<STX>15011501DOE JOE BUNCRENA LI ASTALTxx<ETX>
ID 8 CHAR KENZA 450  LIS (RESULT DATA)
<STX>15011501DOE JOE BUN0030.0000CRE0003.2000NA 0050.0000LI

0045.0000AST0025.0000ALT0031.0000xx<ETX>
id 9 CHAR LIS  KENZA 450

<STX>150115001DOE JOE MALE BUNCRENA LI ASTALTxx<ETX>
ID 9 CHAR KENZA 450  LIS (RESULT DATA)
<STX>150115001DOE JOE MALE BUN0030.0000CRE0003.2000NA

0050.0000LI 0045.0000AST0025.0000ALT0031.0000xx<ETX>
NOTE. Xx have to be replaced with the bcc code
Service Manual 73
File exchange mode
It’s possible the data exchange sharing the folders Datai and Dataio of the installation program folder.
The Kenza 450's program can read the datafiles stored in the DATAI folder with the extension xlm or
csv and can produce a file for each completed sample in the folder DATAIO according to the format
set in the menu
It’s fundamental that the administrator of Kenza 450's computer gives the LIS the
permission for the reading and writing of data in the folder DATAI as well the permission
for the only reading of the folder DATAIO. If not, the LIS can’t read neither write the data
File format CSV (Comma Separated values).

The field separator is “;”
Export file
The filename exported by the Kenza 450 and stored in the folder DATAIO has extension csv and is
formed by the date, time and id of the patient.: YYYY+Month+Day+Hour 24+
Minutes+Seconds+Patient Id”
For example “20131223114545131223001.csv”
The information stored in the file are:
Data and time of last result
Sample ID
Specie (Gender)
Patient Name
For each test required
Test name
Sign (“ “,”<”,”>”) none, less than, greater than
Result value
Units of measure
Result flag
Range minimum
Range Maximum
At the end of the file

string EOP (end of patient)
Import file
The folder is DATAIN and the files must have the extension ".csv"
The information stored in the file are
Data and time of sending
Patient ID
Specie (Gender)
Patient Name
For each test required
Test name
Example Output csv files
2013-12-23T11.45.45;131223001;Man;John ;GL ;584; ;mg/dl ; R OD HI FL
;60;110;BUN;1;<;mg/dl ; OD ;10;50;CRE;0,01;<;mg/dl ; OD ;0,3;1,4;EOP
Using XML file

The file name has extension “.xml” and follows the xml version=1.0 and use encoding=utf-8
For the export

This file is stored in the folder DATAIO located in the program folder.
Service Manual 74
The name is formed by the date, time and the ID of the patient: YYYY+Mont+Day+Hour 24+
Minutes+Seconds+Patient Id”
For example “20131223114545131223001.xml”
The tag and the attribute used are:

Tag Attrib Description
<lab-result> Device version Name of device , software version
<date> Date of report
<patient-id> Patient number
<species> Specie name
<patientname> Patient Name
<results> Set of patient results
<param> Parameters tested
<name> Test name
<value> Result value
<valuetext> Sign of result value
<unit> Measurement unit
<flag> Flags of result
<min> Range min
<max> Range max
For the export the files have to be stored in the DATAI folder stored in program folder. The file name
has to have the xml extension. The only information read from input xml file are:
Tag Description
<patient-id> Patient number
<species> Specie name
<patient-name> Patient Name
<results>
<param> Parameters tested
<name> Test name
Example OUTPUT XML file:

<?xml version="1.0" encoding="UTF-8" ?>
- <lab-result device="Kenza 450 Rel. 2.11 LIS" version="1.0">
<date>200001010100</date>
<patient-id>0021</patient-id>
<patientname>John Doe</patientname>
<species>Man</species>
- <results>
- <param>
<name>GL</name>
<value>0,00</value>
<valuetext />
<unit>mg/dl</unit>
<flag />
<min>50</min>
<max>120</max>
</param>
- <param>
<name>CRE</name>
Service Manual 75
<value>0</value>
<valuetext />
<unit>mg/dl</unit>
<flag />
<min>0,9</min>
<max>1,2</max>
</param>
</results>
</lab-result>
6.1 How to transmit and receive

The Kenza 450's software sends and receives patients’ data on decision of the user or in real-time
mode.
6.1.1 Communication controlled by the user

To start the data transmission in manual mode, access the mask for the patients acceptance where
through the button "Data transfer" is possible to access the menu for reception and transmission of
data. You can send to LIS all the patients’ results available or only a subset selected. You can also
receive new patients from LIS.
Side bar
for
Kenza 450
In manual modality you need to click the button "Data Transfer" to access the menu "data transfer".
Here you find two buttons which allow you to send all the patients data or only a subset or receive
new data from LIS
If the Lis sends the same patient twice, the Kenza 450 recognizes 2 different samples.
Real time communication

In modality "real time" the software continuously hears for data input when the instrument is in idle
mode. The check stops only during the execution of the analysis and when the operator enters the
Service Manual 76
mask for the manual acceptance of patients. During the routine every time all the tests of a patient
are completed, the software checks if the LIS is ready for receiving data.
Scheme of automatic communication on the basis of different states of the program
End of Click on
routine Patient
Routine Idle :
execution Main screen
Start
Exit
Analysis
Kenza 450's
software
Manual
patient entry
When a patient is Every 10 seconds the The automatic

Communication completed, software sends Kenza 450's software communication with LIS is
to/from all the results to LIS checks if there are data disabled but the operator
LIS from LIS, if yes, it receives can manually send or
the patients data receive data
How set the software

Setting of parameters for communication
1. On the main screen click the button below
2. Enter the password and then click the button below
3. The following screen is displayed:
Service Manual 77
Set here the COM port used to communicate with

the LIS (only id8 or id 9 protocols)
Set the Realtime Lis if you want automatic sending of

Set the protocol to be used results as soon available and continuous polling for
incoming data.
The software uses the COM port only for ID8 and ID9 protocol.
In all other cases it writes in the folder DATAIO and reads in the
folder DATAI both positioned in the main program folder
Service Manual 78
Kenza 450 Annex- 1
7 T ABLE OF F LAGS
Service Manual 79
Kenza 450 Annex- 1
Sometimes, close to the results, there are some letters named "flags" which indicate to the operator,
important details concerning the test just run. It follows a table with all flags and their specific meaning.
Flag Meaning Notes
FT Low Fit Valid for kinetic tests – It means that the readout points of a kinetic
reaction do not follow a linear trend. Consequently the "FIT", an
index that indicates the quality of the chemical reaction, becomes
lower than 1
VR Wrong reaction direction direction of the reaction is incorrect or the readings of the optical
density do not follow the preset direction
R Repeated It appears next to the result of a test that has been repeated
RD Repeated with dilution It appears next to the result of a test that has been repeated with
dilution
ES Substrate exhaustion Valid for kinetic tests and Initial rate – the reagent substrate was
exhausted quickly before carrying out the first readout
LO Low value The result is below the reference lower limit
HI High value The result is above the reference value higher limit
FL Out of linearity limit The result is above the preset linearity limit – it is recommended
repeating the test with dilution
FC Out of calibration curve In case of calibration multipoint, the result is above the maximum or
below the minimum calibration point
BHI High reagent blank OD Next to the reagent blank OD – the OD is above the preset reagent
blank range
BLO Low reagent blank OD Next to the reagent blank OD – the OD is below the preset reagent
blank range
For results close to 0 or negative, the result displayed will be 1

NV Not valid preceded by many decimal numbers as those specified in the
method parameters (1-0.1-0.01-0.001-0.0001) followed by the code
NV
<B Below blank The result is below the reagent blank range
Service Manual 80
Kenza 450 Annex- 1
NOTES
Service Manual 81
Kenza 450 Annex- 1
Service Manual 82

Service Manual - KENZA 450 - V 01-2016

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Device of In Vitro Diagnosis for analyses of Medical Biology (Clinical Chemistry)

Only for professional use - Respect the legislation in force

Conform to the Directive 98/79/CE

Code GMDN: 15165

Using this Manual

Conventions Used in this User Manual

This section describes the conventional symbols used in this manual:

This symbol indicates a caution. Cautions indicate that appropriate care or

A ground connection is needed

Preventing Electric Shocks

Moving parts while in operations

Preventing Eye Injury

Treating Waste Liquids

Correct Handling of Reagents, Calibrators and Control Serums

Electromagnetic Wave and Noise Precautions

Setting Analysis Parameters

Planned Maintenance Routines

Installation Environment Precautions

System Labels and Displays

BIOLABO warranty on product

1.1 Readout system

according to the test parameters.

1.2 Photometer module

The photometer is composed of the following components:

Position Nm Position Nm Position Nm

1.3 Readout cuvettes

1.4 Robotic system

1.5 Sampling arm

1.6 Sample tray

1.7 Reagent trays

1.8 Washing arm

1.9 Control system

µ- Assembly Chip µ- Assembly Chip

Motor 3 920128 (PN00045-4) ADC 920125 (PN0085-1)

Temperature & level sensor 920131

1.10 Block Diagram

1.11 Hardware error messages

µC Movement Error Description

µ9 1 µController 0 cannot communicate with µController 9 / Diluter Samples

1.12 Interface board

1.13 ADC board

1.14 Motor driver boards

1.15 Temperature & Level sensor control board

1.16 Power supply unit

1.17 Hydraulic system

Sampling of sample and reagents

Washing and drain of liquids

1.18 Hydraulic Diagram

1.19 Technical specifications

Readout mode OD optical density

STAT Function Possible entry of urgent samples at any time

Type of calculation Factor, calibration curve

Optical System Photometer with 9 Interferences from 340 to 700nm (340-380-405-450-505-546-570-620-

Throughput Max. 420 tests/hour; +480 tests/hour with ISE

Sample volume 2-100µL

External tanks Distilled water, waste liquids, cleaning solution

Dimensions and 105(L)x 77(D) x 58 (H)cm-90 Kg

It is important to store the shipping crate of the instrument in anticipation of a future

1. Remove all the clips used to close

2. Remove the cover and lift the

3. Raise the exterior wooden crate

2.2 Selecting a suitable location

2.2.1 Installation environment

2.2.2 Electrical requirements