Analizor

Eurolyser
EUROLYSER
High-tech Random
Access Clinical
Chemistry Analyzer
Most important
considerations …..
Accuracy
Reproducibility
Reliability
The Star ….
 Throughput up to 180 Tests/hour under
speed optimized condition
 Random Access as well as optimized
batch mode available
 Direct Reading System: No flow cell
 STAT available at anytime
Not Just Speed……
 2 independent needles for reagents and
samples
 Preheated Pipetting arms reduces
incubation time
 Faster washing of needles through
separate wash-stations
 Covers all kind of Biochemistry Tests including
Drug Assay, Immunoturbidimetric Assay
 Automatic pre and post-dilution: more choice
and accuracy for icteric or lipemic samples.
 Analysis Modes: End point, Kinetic, Initial Rate,
Multi point endpoint, Multipoint initial rate, and
Calculated methods
Really Flexible
 25 reagent positions
 50 sample positions
 25 primary tubes
 25 positions for serum cups
(controls, standards and samples)
 Removable Inner Carousel for
overnight refrigeration
 Outer Carousel: 300 test positions (75
x 4 cuvettes) with incubators.
 Primary tubes can be used instead of
sample cups.
Flexibility – another name of
user friendliness
 Microsoft Windows based extremely User

friendly Software with Online Helps
 Superb Graphic display
 Easily programmable module based
DETect Software
 Easy software up-gradations.
Genuinely Accurate
 Extremely Reliable Photometer with LED
technology
 Less than 1% CV
 Resolution: 0.0001 Abs
 Highest Linearity (0-3.000A): So it can measure high value
sample without dilution
 Highly accurate liquid handling system:
less than 2% CV for > 10 µl
 Special technology for Bubble & Foam Elimination
Genuinely Accurate
 High precision two Hamilton syringe pumps
controls the liquid system
 Performance over environment:
 Pre-heated pipettes
 Dip & Sip process: proper mixing of sample &
reagents
 Temperature control for reaction cuvettes
allows no temperature variation

So, highest quality of results due to proper
mixing, correct temperature maintenance of the
needles and reaction cuvettes
Independent probes: No
contamination
 2 independent stainless steel
probes dedicated for reagent and
sample: no contamination
 Sample: 2-200 μl in 1 μl steps
 Reagents: 1-1000 μl in 1 μl
steps: micro volumes save cost
and 1ul step allows proper ratio
of reagent and sample
No carryover, no clogging…
best results
 Independent liquid channels for sample
and reagent
 Dedicated wash stations for each probe:
No chance of carry over
 High pressure washing (1.4 bar): No
chance of clogging
 Back flush function: Proper Internal and
external washing
 Hence, more safety and most accurate
results
Software: user friendly
Reagents
on tray
Samples on
tray
Reagents
Software: more and
more…
 Display of status during process run
 Automated calibration and QC routines with L-J
curve
 Maximum 1day requires
to train a technician
 True open channel:
Other manufacturer’s
reagents can be
programmed
Overall value of money
 Extremely reliable LED system: No lamp
replacement
 Micro Volume of reagents
 Low water consumption: ½ lit/hr in
highest throughput
 Low Power Consumption: 150 VA only.
Most cost effective…..
 Minimized yearly maintenance
 Syringe pumps: No change of peristaltic
tubes
 High quality probes: No cost of tips
 Reliable Hardware inputs
Upgraded technology
 High precision independent pipettors
equipped with extremely precise
frequency based level sensors with
each probe.
 Microsoft Windows Based user
friendly software: NO DOS Based
software
DOS is command based and user
interpretations are more….
Upgraded technology
 Both Test wise or Patient Wise
reporting is possible
 Optional on-board cooling
 Infinite data-storage depending
on the size of hard disk
Service: The backbone
 Our Experience and Expertise
 Complete commitment
Multiple engineers trained in AUSTRIA
 All engineers well equipped with
knowledge as well as tools on instrument

servicing
 Highest availability of spares
The summary
Features Benefit
Easy operation Reagents can be used after an easy
application procedure
Direct Reading System No carryover problem as known in

flowcell systems
LED System Most reliable and cost effective, no

heating of reaction cuvettes
Two independent needles No carry over

no contamination
Use of primary tubes No intermediate manual pipetting steps

required
Low total cost of Ownership Most cost effective solution in the market
EUROLYSER CCA 180
MARKETING MANUAL
Notice
Every effort has been made to avoid errors in text and diagrams, however, Eurolyser Diagnostica
GmbH, assumes no responsibility for any errors which may appear in this publication.
It is the policy of Eurolab to improve products as new techniques and components become available.
Eurolab therefore reserves the right to change specifications at any time.
We would appreciate any comments on this publication.

Eurolyser Diagnostica GmbH
Bayernstrasse 11a
5020 Salzburg, AUSTRIA
web: www.eurolyser.com
Page 1-17............Instruments Description

Page 18-22..........Clinical Evaluation
G. Bonecker Eurolyser CCA 180 Marketing Manual / Version 12.06 1

Instrument Description
EUROLYSER CCA 180 is a fully automated, random access Clinical Chemistry Analyser for wet
chemistry applications. It has an open structure, so that reagents from most manufacturers can be
used on the system.
EUROLYSER CCA 180 is computer controlled and uses the Software Package "DETect" for data
reduction and result evaluation. It is a dedicated walk away system.
EUROLYSER CCA 180 has been developed in a way as to maximise throughput at maximum
comfort, and at the same time to minimise maintenance efforts to be taken by the user.
EUROLYSER CCA 180 is fitted with a patented LED based, maintenance free linear photometer,
featuring 20 reading channels for individual wavelength selection and maximum flexibility.
Target customers for EUROLYSER CCA 180:
Small and middle size hospitals
Doctors offices
Lab – communities
Emergency rooms
Backup unit for big analysers in big reference labs
System Characteristics
Access Modes:
Random Access
Stat (immediate access and execution)
Analysis Modes:
Endpoint (Substrates)
Kinetic (Enzymes)
Initial Rate (fixed time kinetics)
Multipoint (non - linear tests)
Serum Blank
Bichromatic
Intermethode Calculation (LDL friedewald etc.)

Specifications
Throughput:
150 - 180 Tests/hr endpoint monoliquid
Liquid Handling:
2 independent Syringes: Sample: 1 - 250µl in 1µl steps
Reagent: 5 - 999µl in 1µl steps
Minimum reaction volume 180µl
High pressure washing
Autocleaning
Easy maintenance
Measurement System:
Maintenance Free !
Three year warranty on entire optical system!
Light sources: LED (light emmiting diode)
Detectors: Photodiodes
Temperature controlled
5 inbuilt photometers, 4 channels each
Standard filters: 365, 405, 505, 546 & 620nm (4 each)
Resolution: 0,0001 ABS
Accuracy: <1% CV at 1ABS / 405nm
Precision: + / - 0,5% at 1 ABS / 405nm
Temperature Control:
Optional Reagent cooling ambient minus 10°C (water circulation with external cooler)
Cuvette heating (electrical) in carousel and reading path: 37°C
Carousel:
25 reagent positions; 50 positions without serum cups
50 sample positions (random access) for samples, standards and controls
300 test positions (75 x 4 cuvettes)
Customized carousels available
Power Requirements:
85-264V, 50/60 Hz (autodetecting)

Specifications continued
Measures:
Dimensions: 810 x 550 x 550 (w x d x h)
Weight: 28kg
Environmental requirements:
18 - 35°C
10 - 90% relative Humidity
Options:
External ISE module for electrolytes
Handheld Barcode Reader for positive Sample ID
Reagent cooling
Disposables:
Cuvette block for 4 tests each
Reagent bottles
Serum Cups
Cleaning agent for System liquid
Special Cleaning Agent for weekly maintenance
Features & Benefits
General
Feature Benefit
Open system Reagents from any manufacturer can be used after
a short application procedure
Direct Reading System No carryover problem as normally known from
flow-cell systems
Disposable Cuvettes same quality for each test
Can use samples from primary tubes no intermediate manual pipetting steps required
Lowest Total cost of Ownership (TCO) Most cost effective solution on the market, if
purchase price, consumables and maintenance cost
are compared over the live span of the instrument

Features & benefis continued
Software Package DETect

ect
Feature Benefit
Windows (tm) based (XP or 2000) standardised Windows (tm) command sets, easy to
use standard Windows (tm) environment
Connected to EUROLyser via RS 232 no special PC – cards required
Multitasking while processing tests, PC can be used for other
issues
Clearly arranged working surface safe and easy to use
Definition Wizards for both, patient data and safe and easy to use
protocols
Flat menu structure easy to use and to understand
Status display during process run safe control of test status
Stat button with wizard function safe process of emergency samples
Automated sample dilution in case of “out of range” results, samples are re-
tested automatically
Adaptable data interface easy implementation in laboratory data
management systems
Automated calibration and QC routines maintains stable quality of test results
Instrument
Liquid Handling
Handling
Feature Benefit
Open structure, all parts easily accessible easy maintenance
High precision Syringe pumps and Membrane long life time, minimised precision drift compared
pumps to peristaltic pumps
Two independent high precision syringes, one No compromises in pipetting precision:
for sample and one for reagent pipetting.
- sample from 1µl up to 250µl in 1µl steps
- reagent from 5µl to 999 µl in 1µl steps
Min. reaction volume 180µl highest output from valuable reagents
Syringe modules are standard products as used approved quality
in high throughput pipetting robots
Pick- and Drop system minimised death volume
Stainless steel probes maximised life time, optimised washing results
Liquid detection (Sample & Reagent) process safety for full walk away operation
Both Probes heated minimised pre-incubation times
High pressure probe washing (sample & minimised carry over
reagent)

Features and Benefits continued
Measurement System
Feature Benefit
LED technology Maintenance free, low power consumption, no
heat development
Patented strange light compensation independent from light environment
20 reading channels fast reading with flexible wavelength selection
Linear order of reading channels shortest handling distances
Positive cuvette detection maximised process safety
Temperature controlled optimised reaction environment, especially for
kinetic evaluations
more than 500 ABS Modules installed in the field approved quality
in other OEM systems
Sample & Reagent Carousels

Feature Benefit
Inner carousel can be easily removed Overnight refridgeration outside of the system
Inner carousel cooled (optionally) enhanced shelf time of reagents
Outer carousel temp. controlled optimised reaction environment
Positive position control maximum process safety

Competitive Analysis
Parameter Eurolyser CCA 180 Vital Selectra 2 Vital Selectra E

Throughput 165 - 180 tests / hour up to 180 tests / hour up to 180 tests / hour
Random Access Yes yes yes
Open System Yes yes yes
Electrolytes (ISE) optional optional optional
Stat function yes, unlimited positions yes, 3 predefined po- yes, 3 predefined
sitions positions
Windows Software Yes no yes
External PC Yes yes yes
Test Positions 300, cont. loading 48 Cuvettes, cont. 48 Cuvettes, cont.
washing washing
Reagent Positions 25 á 50ml 24 á 25ml and 8 á 5ml 24 á 25ml and 8 á 5ml
Sample positions 50 sample and / or 51 sample and / or 51 sample and / or
calibrators calibrators calibrators
Primary tubes Yes yes yes
Sample identification external Barcode external Barcode external Barcode
reader (optional) reader (optional) reader (optional)
Reagent cooling optional yes yes
Reagent Pre-heating optional yes yes
Mixing function yes yes yes
Liquiddetection both probes both probes both probes
Temp. Control yes, 37°C yes, 37°C yes, 37°C
min. reaction volume 150µl 220µl 220µl
Multi Reagent Tests 1 – 3 reagents 1 or 2 reagents 1 or 2 reagents
Pipetting system Syringes, pick and drop Syringes, pick and drop Syringes, pick and drop
Automatic Dilution if yes no no
result out of range
Pre-dilution yes yes yes
Reading System 20 channel photometer single channel single channel
with up to 20 photometer with filter photometer with filter
wavelengths wheel (8 filters max) wheel (8 filters max)
Light source LED Quartz Iodine, 20 Watt Quartz Iodine, 20 Watt
Lambda Range 340 – 900 nm 340 – 620 nm 340 – 620 nm
Measures W H D (kg) 810 x 550 x 550 (28) 1150 x 540 x 550 (n.a.) 1150 x 490 x 560 (n.a.)
Autosensing PSU yes, 85 – 264 V, no no
50/60Hz

Competitive Analysis continued
Parameter Eurolyser CCA 180 Cobas Mira Cobas Mira Plus

Throughput 165 - 180 tests / hour 120 tests / hour 132 test / hour
Random Access yes yes yes
Open System yes yes yes
Electrolytes (ISE) optional optional optional
Stat function yes, unlimited positions yes yes
Windows Software yes no no
External PC yes inbuilt PC with limited inbuilt PC with limited
memory memory
Test Positions 300, cont. loading 75 (loader optional) 75 (loader optional)
Reagent Positions 25 á 50ml up to 30 up to 30
Sample positions 50 sample and / or 10 – 30 10 – 30
calibrators
Primary tubes yes yes yes
Sample identification external Barcode PosID (optional) PosID (optional)
reader (optional)
Reagent cooling optional optional optional
Reagent Pre-heating optional yes yes
Mixing function yes yes yes
Liquiddetection both probes yes yes
Temp. Control yes, 37°C 25 – 40°C 25 – 40°C
min. reaction volume 150µl 150µl 150µl
Multi Reagent Tests 1 – 3 reagents 1 – 4 reagents 1 – 4 reagents
Pipetting system Syringes, pick and drop Syringes, pick and drop Syringes, pick and drop
Automatic Dilution if yes yes yes
result out of range
Pre-dilution yes yes yes
Reading System 20 channel photometer 1 channel photometer 1 channel photometer
with up to 20 with filter wheel (5 with filter wheel (5
wavelengths pos) pos)
Light source LED Xenon Xenon
Lambda Range 340 – 900 nm 340 – 700 nm 340 – 750 nm
Measures W H D (kg) 810 x 550 x 550 (28) 730 x 580 x 640 (80) 730 x 640 x 58 (100)
Autosensing PSU yes, 85 – 264 V, no no
50/60Hz

Competitive Analysis continued
Parameter Eurolyser CCA 180 Bayer Express Plus

Throughput 150 - 180 tests / hour 180 tests / hour
Random Access yes yes
Open System yes yes
Electrolytes (ISE) optional n.a.
Stat function yes, unlimited positions yes
Windows Software yes no
External PC yes inbuilt PC with limited memory
Test Positions 300, cont. loading up to 195
Reagent Positions 25 á 50ml up to 13
Sample positions 50 sample and / or 40 secondary cups or 20 primary tubes
calibrators
Primary tubes yes yes
Sample identification external Barcode yes
reader (optional)
Reagent cooling optional n.a.
Reagent Pre-heating optional n.a.
Mixing function yes yes
Liquiddetection both probes yes
Temp. Control yes, 37°C n.a.
min. reaction volume 150µl n.a.
Multi Reagent Tests 1 – 3 reagents n.a.
Pipetting system Syringes, pick and drop Syringes, pick and drop
Automatic Dilution if yes no
result out of range
Pre-dilution yes yes
Reading System 20 channel photometer Halographic Reticle, 1 channel
with up to 20
wavelengths
Light source LED Halogen
Lambda Range 360 – 900 nm 340 – 600 nm
Measures W H D (kg) 810 x 550 x 550 (28) n.a. (77)
Autosensing PSU yes, 85 – 264 V, no
50/60Hz

EUROLYSER CCA 180 - FAQ
General
Where is the Eurolyser made?

The Eurolyser is designed and manufactured in Austria, a member of the European Community.
Austria - like Germany - is known for it’s superior technical know how, highly skilled engineers and
high quality products (and of course - for it’s great musicians like Mozart, Schubert, Bruckner….)
The Eurolyser is not the cheapest analyser in its (bench top) class. How is it possible that the
instruments can offer the lowest cost per test?
test
Over the life span of the instrument more than 95% (!) of the test costs are determined by the
reagent consumption. Hence the instrument purchase price is not the most important factor – the
running cost determine if the system (instrument + reagent consumption + maintenance cost) is cost
effective. Due to its outstanding LED photometer the Eurolyser needs less reagent volume than any
other instrument in its class – which results in the lowest cost per test (also called: Total Cost of
Ownership)
Why is a LED (light emitting diode) based photometer better than a halogen lamp photometer?
LED’s have several advantages: they do not drift in wavelength, therefore they are much more
accurate. This accuracy in turn allows lower reading volume of reagents, which results in
tremendous cost savings for the user; LED’s generate no heat – no cooling fan is necessary, no dust
in the instrument, no energy wasted. Additionally, LED’s life span is 100.000 (!) times higher than the
life span of a halogen lamp – they are literally maintenance free! (which of course also results in
lower running cost
Does system have STAT facility?

Yes
What is the average "turn-

"turn-around" time for a STAT?
Depending on test type(s) and reagent manufacturer. STAT samples can be started immediately by a
dedicated software menu.
How many on-

on-line tests are resident in memory?
Unlimited, as the instrument is PC controlled. All protocols are stored on Hard disk or on network
drives, if PC is connected to network.
What are the different types of analysis methods that the instrument can handle, like specific
proteins ?
Eurolyser handles all kinds of tests, which are made under wet chemistry environment.

EUROLYSER CCA 180 FAQ continued
What is the sample processing capacity or throughput for end points/enzyme tests?
Throughput: more than 160 - 180 tests/hr. (End Point Mono Liquid) Sample throughput is depending
on how many tests are performed per sample. So you have to divide 160 - 180 by the number of
tests per sample to have the sample throughput.
How many test results can be held

held in memory at a time?
In principal, unlimited, as the instrument is PC controlled. All results can be exported to Harddisk or
on network drives, if PC is connected to network. However, the software provided by Eurolab is
not intended to act as a patient database. Recalling results is not possible.
Installation and Maintenance

What are the basic pre-
pre-installation requirements?
Table, mains power connection, a little time.
Does the system need any special facility like on-

on-line de-
de-ionised water supply, plumbing, draining
etc?
For optional reagent cooling system an external water cooler is required.
System liquid is DI or distilled water, mixed with standard cleaning agent, kept in external containers
connected to the instrument.
Calibration
What is
is the calibration frequency suggested ?
System is in optics absolutely stable, so that the calibration frequency only depends on the reagents
used. Eurolyser is an open system, so the calibration frequency depends on the reagents
manufacturer.
How many standards

standards can be used for linear calibration?
Up to 10
How many standards can be used for non-

non-linear calibration?
Up to 10
Can test be recalibrated with as well as without samples, or only during a run?
Calibration of the system is a completely separated “run” with only calibrators and controls.

Is it possible to store calibration data with graphical output?

Yes
Is the calibration process ‘automatic’ (as in Hitachi 912) or semi automatic - as in Vital Selectra II
Semi automatic
Software Flexibility
Are the test parameters alterable that is, is the system open?
Yes, the system is fully open.
Does the system have graphic facility for display of standard curves?
Yes
What are the various calculation methods that can

can be selected?
Linear, linear interpolation, logit/log 4 point, logit/log 5 point and exponent 5 point,
Spline,Point to Point,Point to Point extrapolated up to the ,iniarity limit.
Instrument
Is it possible to wash and reuse the analysis cuvettes?

It is not recommended to use cuvettes multiple times (although it is possible for a few times; please
note that washing the cuvettes may lead to wrong test results!)
Does the system optically check cuvettes before analysis?

It is possible to program a process blank which blanks every single cuvette. Furthermore when
running endpoint tests in bichromatic mode, this will subtract eventual optical influences caused by
the cuvettes.
What is the path length of the cuvette, or is it variable, based on pipetting volume?
The optical path is appr. 6,8 mm and not variable. The minimum volume required for proper
measurements is 180µl per test in total in order to fill the reading chamber of the cuvette.

How is the temperature controlled

controlled by peltier or thermostatic bath, and what is the stability in the
analyser area?
The reading path as well as the cuvette - carousel is heated by resistors, which are in a control circle
with temperature sensors. The system automatically maintains a stable temperature.
Sample / Reagent Handling
What is the type of the sample/reagent dispensing mechanism?

High Precision Syringe pumps. Pick and drop system (no flow through system)
What is the dispensing sample volume range?

1 - 250µl in 1µl steps
What is the dispensing reagent volume range?

What is the diluent volume range involved?

What are the technical specifications like carry-

carry-over, accuracy, precision etc. for the (a) sample (b)
reagent
re agent dispensing systems?
Zero carry over due to high pressure washing system between each sample / test.
Accuracy: < 1% at full stroke (at 250µl for sample syringe and 999µl for reagent syringe)
Precision: <= 0,05% CV at full stroke (at 250µl for sample syringe and 999µl for reagent syringe)
How many reagents can be kept on-

on-board at the same time?
25 different, in up to three different reagent bottle types. If no primary tubes are used the
instrument can handle up to 50 reagent positions
Is it possible to add new reagents, during analysis for new tests?

Yes, instrument will interrupt run upon request.
on--board cooling is offered ?

How many reagents are kept under refrigeration if on
all 25 positions. (Or 50 positions if nor primary tubes are used)

23°c?
What is the reagent cooling temperature reached, say at an ambient temperature of 23°
appr. 10°C below ambient
How many test reagents can be added automatically for a test - 2,3 or 4 ?
Up to 3.
What are the maximum number

number of samples that can be loaded and is it possible to have access
continuously for sample loading?
Up to 50 Samples. Yes, random access is possible.
What is the capacity and dead volume of the sample cup?

Sample cups are either primary sample tubes or serum cups (standardised). The carousel, however,
can be custom made for any diameter on primary tubes. Dead volume in Serum cups / primary tubes
is approximately 120µl
What are the volumes of the reagent containers and what are dead volumes?
The volume of the reagent containers is 50ml,20ml or 10ml (the dead volume is less approx 1 ml.)
Is it possible to use adapters for say different volumes say 30 or 35ml, 20 or15ml, or 3-
3-5ml for low
volume tests like CK-
CK-MB, amylase etc?
Yes, there is an adapter available as an option, which is placed in a reagent – bottle position of the
carousel. Iot helds a 4ml tube for small volumes.
Are the sample/reagent pick up direct like in ILab 600 (from Instrumentation Laboratory, USA) or
involving dead volume losses like in Hitachi 911 or 912?
The sample / reagent pipetting uses a “pick and drop” system with almost zero death volume.
Do the systems have pre- 37°°c before analysis?

pre-heating for sample and reagent probes to bring to 37
Yes, both probes are heated.
What are the different

different types of sample cups, (primary tube, open or closed tubes?) the system can
work with?
Pre-opened primary tubes or Serum cups. Carousel standardised for tubes with 15 mm and serum
cups with 10mm diameter. Custom made carousels can be ordered. Cap piercing is not possible.
How are the samples and reagents identified – by barcode reader or scanned across?
By optional, handheld barcode reader, connected to PC.

If bar code is used, what symbologies are used?

2 of 5, Code 39, Code 93, Code 128, Code 32, Code 39 CIP, EAN 128, EAN/UPC, Codabar
Measurement
What are the temperatures available for measurement and Incubation?

37°C.
What is the stability of temperature at set point?

+/- 0,2 °C
Does the system display results

results and print-
print-out, or only print-
print-out is available?
Both, display and printout
Is there any on-

on-line washing facility for the reaction cuvettes?
No. We do not recommend to re-use cuvettes, since washing quality is very much depending on too
many different parameters. The cost for the cuvette per test is very low. Compare this price with
the cost for washing (liquid, power, time) and add a risk value for improperly washing results,
trouble shooting procedures caused by this. This rectifies to use best quality for each test.
Is it possible to 'repeat' measurement?

Yes
re--
Is it possible to dilute sample automatically, and rerun if substrate depletion occurs and re
measure?
Results which exceed the linearity limit of the chemistry are automatically re-tested. The first re-run
will be with lowered sample amount to increase the Linearity range. If still out of range, sample will
automatically be re-tested by adding double reagent volume additionally to the decreased sample
volume.
Optics
What is the type of optics employed - filters or grating or photodiode array system?
Interference filters
What is the wavelength accuracy and half bandwidth?

Accuracy: +/- 2nm Bandwidth: +/- 10nm

What is the linear range of the photometer

photometer ( say 0.000 to 2.300 ??) and reproducibility?
400 - 800nm 0 - 3.0 OD
360 - 400nm 0 - 2.5 OD
What is the approximate life span of the lamp?

The Eurolyser has a LED photometer; contrary to a halogene lamp (average life span 1.500 hours) ,
the LED system lasts forever (> 100.000 hours)
What are the unique features and benefits of the “patented linear type photometer” over
conventional type?
This photometer is fitted with LEDs as light sources, which make the system maintenance free. The
reading is disconnected from the other process steps, this means that during reading (e.g. kinetics),
the instrument continues pipetting.
It is connected to special electronics, which make it fully independent from ambient light. The 20
inbuilt photometers are in linear order, the cuvettes are moved like in a street through all 20
channels, and each cuvette is measured at the required position with the required wavelengths.

CLINICAL EVALUATION
Comparison Instrument : Hitachi 911

Brand of Chemistry : Roche
Testing
Testing period: August 2002
Person in charge: Dr. Thomas Pichler University of Salzburg
The patient sera used for this evaluation were provided by the Central lab of the Salzburg County
Hospital. The chemistry used was identical in brand as originally used by the State Hospital. The
testing was done within the facilities of Eurolab by an independent Biochemist (Dr. Pichler) from the
University of Salzburg. The results obtained have been directly compared to the original results from
the Central Lab.
Parameter: TP GLU UA CHO TRI UREA GOT GPT GGT AMYL

Unit: (g/dl) mg/dl mg/dl mg/dl mg/dl mg/dl U/l U/l U/l U/l
Wavelength: 546nm 505nm 546nm 505nm 505nm 365nm 365nm 365nm 405nm 405nm
Instrument: Patient
Hitachi 1 4.2 116 8.1 77 76 166 86 168 26 222
Eurolyser CCA 180 1 4.25 119.98 7.97 78.51 83.09 165 84.35 165.82 25.4 203.27
Hitachi 2 7.3 94 5.3 132 87 31 16 33 109 54

Eurolyser CCA 180 2 7.24 95.82 5.32 131.4 90.5 30.68 20.31 32.47 112.49 50.67
Hitachi 3 5.4 177 5.7 102 71 48 37 41 124 55

Eurolyser CCA 180 3 5.5 187.07 5.95 106.06 76.12 48.63 40.1 41.78 128.55 51.55
Hitachi 4 6.5 108 3.8 242 273 29 9 12 15 38

Eurolyser CCA 180 4 6.72 117.18 3.69 255.3 283.26 29.53 11.27 15.65 13.85 36.54
Hitachi 5 4.6 116 3.4 129 304 116 23 21 34 377

Eurolyser CCA 180 5 4.86 128.02 3.49 136.61 319.28 116.95 21.09 26.56 28.33 341.93
Hitachi 6 6.5 84 5 222 181 38 10 12 10 60

Eurolyser CCA 180 6 6.52 95.19 5.07 233.75 174.46 35.32 15.2 9.83 60.1
Hitachi 7 5.3 107 1.4 113 105 20 8 9 11 21

Eurolyser CCA 180 7 5.29 113.24 1.43 119.22 107.93 18.53 9.56 10.33 10.92 20.44
Hitachi 8 4.8 169 1.8 136 78 44 10 8 4 185

Eurolyser CCA 180 8 4.89 176.18 1.66 139.08 81.49 38.79 9.59 2.96 185.85
Hitachi 9 4.8 148 3.8 175 124 29 20 12 6 37

Eurolyser CCA 180 9 4.92 151.71 3.97 169.02 129.14 28.37 21.15
21 .15 12.66 4.57 35.53
Hitachi 10 4.9 115 3 179 95 22 7 5 18 38

Eurolyser CCA 180 10 5.08 119 3.05 171.63 103.28 22 13.61 7.76 20.62 41.47

Correlation:
Cholesterol: Results:
Pat. ID Hitachi Eurolyser CCA 180 350
1 77 78.51
300
2 132 131.4
250
3 102 106.06
200
4 242 255.3
5 129 136.61 150
6 222 233.75 100
y = 1,0286x + 1,4643
7 113 119.22 50
R2 = 0,9966
8 136 139.08 0
9 175 169.02 0 100 200 300 400
10 179 171.63
Triglycerides Results:
Pat. ID Hitachi Eurolyser CCA 180
1 76 83.09 300
2 87 90.5 250
3 71 76.12 200
4 273 283.26
150
5 304 319.28
100
6 181 174.46 y = 1,0381x - 2,3851
7 105 107.93 50 R2 = 0,9861
8 78 81.49 0
9 124 129.14 0 50 100 150 200 250 300
10 95 103.28
Glucose Results:
200
1 116 119.98
2 94 95.82 150
3 177 187.07
4 108 117.18 100
5 116 128.02 y = 1,0079x + 5,9655
50
6 84 95.19 R2 = 0,9873
7 107 113.24 0
8 169 176.18 0 50 100 150 200
9 148 151.71
10 115 119

Correlation:
Total Protein Results:

1 4.2 4.25 7
2 7.3 7.24 6
3 5.4 5.5 5
4 6.5 6.72 4
3
5 4.6 4.86 y = 0,9601x + 0,3135
2
6 6.5 6.52 1 R2 = 0,9907
7 5.3 5.29 0
8 4.8 4.89 0 2 4 6 8
9 4.8 4.92
10 4.9 5.08
Uric Acid Results:

1 8.1 7.97 8
2 5.3 5.32
6
3 5.7 5.95
4 3.8 3.69 4
5 3.4 3.49 y = 1,0018x + 0,0226
2
6 5 5.07 R2 = 0,9958
0
7 1.4 1.43
0 2 4 6 8 10
8 1.8 1.66
9 3.8 3.97
10 3 3.05
Urea Results:
1 166 165
2 31 30.68 150
3 48 48.63
100
4 29 29.53
5 116 116.95 y = 1,0049x - 1,1837
50
6 38 35.32 R2 = 0,9985
7 20 18.53 0
8 44 38.79 0 50 100 150 200
9 29 28.37
10 22 22

Correlation:
GGT Results:
1 26 25.4 120
2 109 112.49 100
3 124 128.55 80
4 15 13.85 60
y = 1,0427x - 1,4709
5 34 28.33 40
20 R2 = 0,9976
6 10 9.83
7 11 10.92 0
8 4 2.96 0 50 100 150
9 6 4.57
10 18 20.62
GOT Results:
1 86 84.35 80
2 16 20.31
60
3 37 40.1
4 9 11.27 40
y = 0,9385x + 3,5133
5 23 21.09 20
R2 = 0,9909
6
0
7 8 9.56
0 20 40 60 80 100
8
9 20 21.15
10 7 13.61
Amylase Results:
400
1 222 203.27 350
2 54 50.67 300
3 55 51.55 250
4 38 36.54 200
150 y = 0,9089x + 3,9401
5 377 341.93 100
6 60 60.1 50 R2 = 0,9975
7 21 20.44 0
8 185 185.85 0 100 200 300 400
9 37 35.53
10 38 41.47

Correlation:
GPT Results:
1 168 165.82
2 33 32.47 150
3 41 41.78
4 12 15.65 100
5 21 26.56 y = 0,9703x + 2,6366
50
6 12 15.2 R2 = 0,9988
7 9 10.33 0
8 8 9.59 0 50 100 150 200
9 12 12.66
10 5 7.76
Repeatability:
Patient 1, all Parameters

GGT GOT GPT AMYL UREA CHO GLU TRI TP UA UREA
Kin. Kin. Kin. Kin I.R. EP EP EP EP EP I.R.
Rep 1 26.96 85.52 165.18 214.12 177.74 79.74 130.14 89.63 4.36 8.71 177.74
Rep 2 26.97 88.7 167.58 215.54 181.21 79.65 121.22 88.03 4.4 8.65 181.21
Rep 3 27.06 88.88 170.34 222.51 187 79.48 123.5 87.45 4.39 8.68 187
Rep 4 27.55 86.96 167.63 218.12 181 79.83 121.53 87.59 4.4 8.64 181
Rep 5 27.28 85.9 163.52 217.9 177.74 80.1 122.57 89.04 4.33 8.71 177.74
Rep 6 27.28 84.62 164.26 217.67 175.42 82.39 119.52 86.45 4.41 8.76 175.42
Rep 7 27.08 83.68 163.6 220.71 181.21 82.48 122.05 89.63 4.38 8.53 181.21
Rep 8 27.34 85.79 168.12 217.52 179.2 80.25 121.01 88.55 4.39 8.7 179.2
SD 0.19 1.72 2.33 2.48 3.25 1.19 3.02 0.99 0.02 0.06 3.25
Avg 27.19 86.26 166.28 218.01 180.07 80.60 122.69 88.11 4.38 8.67 180.07
CV % 0.71% 1.99% 1.40% 1.14% 1.81% 1.47% 2.46% 1.12% 0.56% 0.74% 1.81%
Patient 10, all Parameters pat low!

GGT GOT GPT AMYL UREA CHO GLU TRI TP UA UREA
Kin. Kin. Kin. Kin I.R. EP EP EP EP EP I.R.
Rep 1 21.14 12.54 8.33 47.81 25.47 198.87 129.93 124.05 5.52 3.33 25.47
Rep 2 21.44 12.1 7.94 44.19 26.05 198.16 130.24 126.09 5.63 3.31 26.05
Rep 3 21.35 12.12 8.69 44.22 26.05 200.19 131.49 124.92 5.74 3.42 26.05
Rep 4 21.12 11.98 7.59 46.5 24.89 199.05 129.93 126.38 5.55 3.38 24.89
Rep 5 21.51 11.91 7.06 43.66 22.58 194.72 129.93 124.34 5.49 3.42 22.58
Rep 6 21.22 12.21 7.68 43.23 25.65 202.22 130.12 125.67 5.6 3.37 25.65
SD 0.15 0.20 0.53 1.65 1.20 2.48 0.56 0.75 0.08 0.04 1.20
Avg 21.30 12.14 7.88 44.94 25.12 198.87 130.27 125.48 5.59 3.37 25.12
CV % 0.69% 1.67% 6.67% 3.67% 4.78% 1.25% 0.43% 0.60% 1.47% 1.23%
1.23% 4.78%

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Eurolyser

 Microsoft Windows based extremely User

allows no temperature variation

knowledge as well as tools on instrument

Direct Reading System No carryover problem as known in

LED System Most reliable and cost effective, no

Two independent needles No carry over

Use of primary tubes No intermediate manual pipetting steps

We would appreciate any comments on this publication.

Page 1-17............Instruments Description

G. Bonecker Eurolyser CCA 180 Marketing Manual / Version 12.06 1

G. Bonecker Eurolyser CCA 180 Marketing Manual / Version 12.06 2

G. Bonecker Eurolyser CCA 180 Marketing Manual / Version 12.06 3

Features & Benefits

G. Bonecker Eurolyser CCA 180 Marketing Manual / Version 12.06 4

Software Package DETect

G. Bonecker Eurolyser CCA 180 Marketing Manual / Version 12.06 5

Sample & Reagent Carousels

G. Bonecker Eurolyser CCA 180 Marketing Manual / Version 12.06 6

Parameter Eurolyser CCA 180 Vital Selectra 2 Vital Selectra E

G. Bonecker Eurolyser CCA 180 Marketing Manual / Version 12.06 7

Parameter Eurolyser CCA 180 Cobas Mira Cobas Mira Plus

G. Bonecker Eurolyser CCA 180 Marketing Manual / Version 12.06 8

Parameter Eurolyser CCA 180 Bayer Express Plus

G. Bonecker Eurolyser CCA 180 Marketing Manual / Version 12.06 9

Where is the Eurolyser made?

Does system have STAT facility?

What is the average "turn-

How many on-

G. Bonecker Eurolyser CCA 180 Marketing Manual / Version 12.06 10

How many test results can be held

Installation and Maintenance

Does the system need any special facility like on-

How many standards

How many standards can be used for non-

G. Bonecker Eurolyser CCA 180 Marketing Manual / Version 12.06 11

Is it possible to store calibration data with graphical output?

What are the various calculation methods that can

Is it possible to wash and reuse the analysis cuvettes?

Does the system optically check cuvettes before analysis?

G. Bonecker Eurolyser CCA 180 Marketing Manual / Version 12.06 12

How is the temperature controlled

Sample / Reagent Handling

What is the type of the sample/reagent dispensing mechanism?

What is the dispensing sample volume range?

What is the dispensing reagent volume range?

What is the diluent volume range involved?

What are the technical specifications like carry-

How many reagents can be kept on-

Is it possible to add new reagents, during analysis for new tests?

on--board cooling is offered ?

G. Bonecker Eurolyser CCA 180 Marketing Manual / Version 12.06 13

What are the maximum number

What is the capacity and dead volume of the sample cup?

Do the systems have pre- 37°°c before analysis?

What are the different

G. Bonecker Eurolyser CCA 180 Marketing Manual / Version 12.06 14

If bar code is used, what symbologies are used?

What are the temperatures available for measurement and Incubation?

What is the stability of temperature at set point?

Does the system display results

Is there any on-

Is it possible to 'repeat' measurement?

What is the wavelength accuracy and half bandwidth?