Introduction

Introduction

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 Introduction

2.1 Intended use

The Vitalab analyzer is an automatic chemistry analyzer, used in combination with certain reagents for in
vitro diagnostic measurement of analytes in samples of serum, plasma, urine and aqueous standard
solutions. The analyzer is designed as an ´open´ system. Most clinical chemistry tests that require a
photometric measurement can be adapted on the system. The Vitalab analyzer is intended for use in
clinical chemistry laboratories where the workload is of medium quantity. The analyzer has to be operated
by trained professionals.

Disclaimer:
Depending on the specific characteristics of the involved reagent kit, the results obtained from a clinical
chemistry system may vary. The test parameters for each test (and each reagent supplier), need to be
* *
developed by appropriate methods [for example using ECCLS or NCCLS guidelines] before the system
is used for actual measurements of patient samples. Vital Scientific N.V. takes no responsibility for
erroneous test results caused by reagent kits and/or test parameters that are not provided by Vital
Scientific N.V.

*
ECCLS = European Committee for Clinical Laboratory Standards
*
NCCLS = National Committee for Clinical Laboratory Standards (USA)

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2.2 System presentation

The Vitalab analyzer is a universal system. The price-performance-relation is optimized for small and
medium workload (up to 180 tests per hour, or even up to 270 tests per hour when the optional ISE unit is
used). It is easy to adapt the analyzer in any kind of laboratory.
In the main unit of the system, the actual analyzer, all liquid handling and measurements take place. A
separate computer controls the analyzer unit, collects the raw data and provides the user interface. A
cooling unit enables the system to ensure the precision of all ´on-board´ parameters. Environmental
compatibility and economic efficiency are guaranteed. Easy operation (menu and message control by
display), short training time as well as recording of sample and test data with barcode scanner reduce
personnel assignment and save a maximum of time.

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2.3 Analyzer
Note
In the screen texts system liquid is replaced by water.
The Vitalab analyzer is a PC-controlled clinical chemistry analyzer. It is designed as a random access full
selective patient-oriented system. The test parameters for 55 different tests can be programmed. The
analyzer can run simultaneously from 1 up to 26 tests. The analyzer has the following measurement
capabilities:

In the dual mode:

• Reagent absorbance (bichromatic) before sample addition.
• Kinetic 1 during 4,5 minutes after sample addition (can be used as slope blank for kinetic 2)
• Kinetic 2 during 4 minutes after reagent 2 addition.
• Kinetic 1 + 2 during 8.5 minutes after sample addition.
• Sample blank (bichromatic) before reagent 2 addition.
• End point (bichromatic) before reagent 2 addition.
• End point (bichromatic) 4.5 minutes or 11.5 minutes after sample addition or 6.5 minutes after R2
addition.
• Kinetic 1, kinetic 2 and kinetic 1 + 2 can contain a minimum measuring time or two points for two
point measurements.

In the mono mode:

• Reagent absorbance (bichromatic) before sample addition.
• Kinetic during 7 minutes after sample addition.
• End point (bichromatic) 11.5 minutes after sample addition.
• Kinetic can contain two points for two point measurements.
The different reagents are placed in a cooled reagent rotor. A pipette injects the reagents directly into the
reaction cuvettes. The cuvettes are incubated at 37°C, measured at the selected wavelength and washed
for re-use. Bichromatic measurements are possible for endpoint chemistries.
The cycle-time in the mono-reagent mode is 20 seconds, in which the analyzer can do up to 180
tests/hour (with the optional ISE unit 270 tests/hour). The cycle-time in the dual-reagent mode is 27
seconds, in which the analyzer can do up to 133 tests/hour (with the optional ISE unit 222 tests/hour).
Emergency and pediatric samples can be tested without interference of the routine workload.
The Vitalab analyzer is microprocessor controlled. All mechanical functions are driven and checked by
slave-processors. The operator has a constant view on the hardware status and performance of the
chemistries. When errors or flagged results occur, the Vitalab Analyzer offers an automatic re-run facility.
The re-run facility includes automatic sample reduction for high results. The results are printed patient-
oriented and in the analysis sequence. The print is held when a test is in evaluation or re-run. This
prevents mixing-up the analysis sequence. The operator can change the format of the result report. Prints
of calibration curves, reaction curves, Levey-Jennings plots, test methods, etc. are possible.

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2.3.2 Sample rotor

The positions in the sample rotor:
1 Blank
9 Calibrators
51 Samples (can also be used for controls en calibrators)
6 Pediatrics (in case of the optional ISE unit, one position is in use for the ISE activator).
3 Emergencies
4 Controls
1 Wash solution

All positions can contain primary tubes and Terumo 5 ml tubes. Also adapters for low volume containers
are supplied. An optional rotor for Kabe or Sarstedt 5 ml sample tubes is available. The sample rotor is
covered.

Sample pipette mechanism

The sample probe, equipped with a level detector, aspirates any volume between 1µl and 30 µl (in steps
of 0,1 µl). The probe dispenses it into the cuvette rotor and also mixes the reaction mixture. Before
sensing the sample the sample probe will take up an air bubble first. The probe is washed in- and outside
afterwards.

2.3.3 Reagent rotor

Note
For optimum cooling and to avoid waste of energy, cover unused positions during a test with
caps. The caps also prevent evaporation of the reagents.
The positions in the reagent rotor:
24 bottles of 25 ml
(or up to 5 bottles of 50 ml; a 50 ml bottle takes 2 positions of 25 ml bottles)
8 bottles of 8 ml
The reagent rotor compartment is cooled to approximately 12°C below ambient temperature. The rotor is
covered to protect light sensitive reagents and to isolate from ambient temperature.

Reagent pipette mechanism

The level detector in the reagent probe detects if sufficient reagent is present. A heating element in the
probe pre-heats the cooled reagents. Reagents must be prepared outside the analyzer. After the probe
transferred the aspirated volume of reagent into the cuvette rotor, the probe is washed in- and outside.
nd
After a 2 reagent is dispensed, the reagent probe mixes the reaction mixture.

2.3.4 Pipettes
Two syringes, a 1000 µl and a 100 µl, are used in combination with a valve block to pipette reagents and
samples. The pipette mechanisms are water-filled. Reagents and samples are aspirated with air bubble
separation.

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2.3.5 Cuvette rotor

Note
Replace the cuvette rotor when one of the eight wavelengths prints the message SD.ERR
after the rotor blank measurement. The quality and reliability is not guaranteed when the
cuvette rotor is not replaced.
The multi-use cuvette rotor contains 48 cuvettes, incubated at 37°C. The path length is 6.8 mm and the
minimum measuring volume is 220 µl. The cuvette rotor, special made for Vital Scientific, is covered by a
heated cover.
The rotor makes in the mono mode a complete revolution plus one extra step every 20 seconds. In mono
mode the analyzer can measure 22 kinetic points, an endpoint and a reagent blank at any of the 8
available wavelengths during a revolution. The rotor makes in the dual mode a complete revolution plus
one extra step in 27 seconds. In dual mode the analyzer can measure 21 kinetic points, an endpoint and
a reagent blank at any of the 8 available wavelengths during a revolution. In both cases, the value of the
reagent blank is used for various checks and the measurement of the endpoint can be bichromatic.
The maximum incubation time after sample addition is 11.5 minutes in mono mode and 11,25 minutes in
dual mode. The first kinetic point in the mono mode can be measured after 12 seconds, the last after 422
seconds. In the dual mode the first kinetic point can be measured after 24 seconds, the last after 519
seconds. After the last measurement, the rotor is washed and dried. To avoid drying-in of the rotor, the
reagent probe automatically fills the rotor with water.

2.3.6 Washing unit

The washing unit aspirates the reaction mixture after analysis and washes the cuvettes with 4 x 500 µl
water. The waste is disposed in a waste container. Separated waste, concentrated and diluted in two
containers, is available (ex-factory option only). The washing unit is equipped with liquid sensors to avoid
flooding the system with water.

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2.4 Computer control

Note
Only run the software in order to operate the analyzer. The use of other software might cause
failure in the communication between the analyzer and the computer.
An external computer provides the user interface to the analyzer. The software is Windows-based to save
a maximum of time. A keyboard or a barcode reader is necessary to enter data. The test results are
saved on the computer. The software provides a standard way of output on a printer, but the operator can
change the format of the result report. Test parameters, control results and calibration results are also
saved on the computer and ready for access any time.
It is possible to connect the analyzer to a lab data processing system (central processor/host computer).
If so, it is possible to enter test requests directly from the host computer. Also the test results can be
transferred to the host computer.

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2.5 Cooling unit

The analyzer is equipped with an external cooling unit. The cooling unit provides a constant temperature
of the reagents located on the rotor, keeping them fresh (as required by the application prescription).
When an acoustic signal is heard, the cooling liquid must be refilled. The control display shows the
temperature of the cooling liquid. The actual temperature of the reagents will be slightly higher. The user
cannot change the temperature setting of the cooling unit.

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2.6 Barcode reader

Caution
Switch off the computer before you install the barcode reader.
The barcode reader can be connected to the keyboard of the external PC. The reader is used for test
requisition and randomized loading of the samples. Most of the available barcodes can be read, but
Codabar gives the highest convenience. The Codabar start character is used to differentiate between
tests and profiles.

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2.7 Operation requirements

Only a qualified service technician may unpack the analyzer, cooling unit and other devices. Vital
Scientific N.V. does not take responsibility for damage or improper operation of the analyzer, when these
instructions are not observed. The analyzer is inspected and ready for use when it is handed over to the
user.
Use the analyzer in closed rooms. It must be placed on a flat, horizontal surface that is not subject to
vibrations. Avoid exposure to direct sunlight.
The electrical connection has to be grounded according to common regulations, to ensure proper
operation of the analyzer.
The analyzer is compliant with the requirements of the applicable EMC standards. Electronic equipment
that exceed the radiation limits defined in the EMC standards, like GSM and other handheld mobile
equipment, may affect proper operation of the equipment.
Note
This is a class A product. This product may cause interference in a domestic environment. In
this case the user may be required to take adequate arrangements.

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2.8 Move the analyzer

Please follow the instructions below when the instrument needs to be moved over a larger distance:
1. Switch off the analyzer, the computer and the cooling unit.
2. Disconnect all cables and tubes.
3. Remove the door of the syringe compartment by lifting it when fully opened.
4. Pull up the arms and place the arm protection tubes over the shafts. The arms are prevented from
going down.
5. Move the analyzer with at least 2 persons. Hold the instrument only by the metal frame on the
bottom.
6. Connect all cables and tubes again when the analyzer is in place.

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2.9 Performance and technical data

Performance
Throughput MONO MODE: 180 tests per hour (270 with optional ISE unit)
DUAL MODE: 133 test per hour (222 with optional ISE unit)
Accuracy Refer to note 1
Precision Refer to note 1
Programmable tests 55 per programmed reagent disc
Loadable tests 32
Quality control 3 per parameter, 15 controls programmable per reagent disc
Sample processing Entirely selective sample-oriented
Sample volume 1 to 30 µl per test

Sample system
Sample positions 51 patient samples
Emergency samples 3 positions
Calibrators 9 positions plus max. 51 patient sample positions
Pediatric samples 5 positions
ISE position 1
Blank position 1
Controls 4 positions plus max. 51 patient sample positions
Rinsing position 1
Sample tubes Primary/secondary tubes
Diameter: 13-16 mm
Height: max. 73 mm
Sample needle With level detector and integrated mixer
Pipetting capacity 1-30 µl (steps of 0.1 µl)
Syringe 100 µl
Adapter 6 (pediatric, sample rotor)

Reagent system
Reagent rotor 32 positions: 24 × 25 ml, 8 × 8 ml and 5 × 50 ml bottles possible
Volume/test Reagent 1: 110 – 399 µl, reagent 2: 0, 10 – 180 µl
Cooling Up to 12 °C below ambient temperature
Needle Pre-heated, with level detector and integrated mixer
Pipetting capacity 400 µl (steps of 1 µl)
Syringe 1000 µl
Adapter 8 (for 8 ml bottle in 25 ml position)

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Measurement Station
Cuvette rotor Multi use disposable rotor with 48 positions
Path length 6.8 mm
Minimum volume 220 µl
Wash station fully automatic with overflow-level detector
Cuvette rinsing 4 × 500 µl system liquid
Light source Halogen lamp 12V 20W
Wavelength 340, 376, 405, 436, 505, 546, 578, and 620 nm
Wavelength uncertainty +/- 2 nm
Spectral half-width value 10 +/- 2 nm
Measuring range -0.1 to 3.0 Abs.
Temperature 37 °C ± 0.2 °C
Cycle time 20 sec. (MONO MODE)
27 sec. (DUAL MODE)

Minimum PC Requirements
CPU Intel Pentium 133 MHz
RAM 32 MB
Monitor VGA Monitor 640 x 480 pixel
Hard Disk 1 GB
Floppy Disk drive 3.5” (1.44 MB)
Additional drive CD-ROM drive
Operating system Windows 98 Second Edition or 2000
Serial ports 1 for analyser, 1 for host*, 1 for printer 2*
Parallel port 1 for printer

* depending on options used

Cooling unit
Weight (empty) 19.6 kg
Weight (filled) Approx. 23 kg
Required space 84 cm²
Dimensions (cm) 24W × 37H × 35L
Coolant 3.5 l, glycol-based
System Closed circulation
Connection Mains connector
Power consumption 340 VA max.
At operating voltage 110 or 230 VAC (device-dependent)
Line frequency 50/60 Hz

Barcode reader
Version Hand device
Technology CCD
Barcodes UPC-A +2, +5
UPC-E +2, +5
EAN-13 +2, +5
EAN-8 +2, +5
Code 39
Code 93
Code 128
Codabar
Code 2 out of 5
Code 2 of 5 interleaved
MSI/Plessey

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Note 1: Accuracy and precision

The chemical performance of clinical chemistry analyzers, in terms of accuracy and imprecision, depend
on the following: the characteristics of the instrument; the measurement techniques and the materials
used. Therefore, the chemical performance characteristics of a clinical chemistry analyzer can only be
established and postulated in terms of: the analyte; the specific reagent kit and calibrator(s) used; the
type and constitution of the specimens involved; etc.
The Vitalab analyzers are designed as open systems. ´Open´ implies that most clinical chemistry tests
and techniques that require photometric measurement, can be adapted on the system. Only the test
parameters for a specific test need to be adjusted. The user needs to establish the required test
parameter settings to achieve satisfactory results, utilizing appropriate methods. The methods are
preferably based on international guidance documents, for example ECCLS or NCCLS guidelines.
Vital Scientific N.V. does not suggest or propose any particular reagents, calibrators and/or controls on
their analyzers from a specific manufacturer. Obtain information on the performance characteristics from
the selected reagent distributor and/or manufacturer. Various reagent manufacturers have performed
performance studies on the Vitalab series in combination with their reagent kits. Therefore, they have
application sheets available for various analytes. The required information usually can be obtained from
the reagent package inserts. Please contact your local representative and/or reagent manufacturer for
further information on the chemical performance of their reagents on Vitalab analyzers.

Disclaimer
Vital Scientific N.V. assumes no responsibility for erroneous test results caused either by the reagent kits
and/or calibrators or for inadequate use and determination of test parameters.

2.9.2 Analyzer Technical Data

Dimensions and weight

Width 115 cm
Depth 56 cm
Height 49 cm
Weight Approx. 85 kg

Power requirements
Line Voltage 110/240 V nominal, tolerance 10%
Line Frequency 50/60 Hz
Power Consumption 320VA
Installation category II (in accordance with IEC664)

Environmental requirements
Ambient temperature 15 to 32 °C
Max. relative humidity 85 % RH max.
Pollution degree 2 (in accordance with IEC 664)

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