EUROLYSER CCA 180 MARKETING MANUAL

Transcription

1 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 Eurolyser to improve products as new techniques and components become available. Eurolyser 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: Page Instruments Description Page Clinical Evaluation G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

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

3 Specifications Throughput: 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: 340, 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: V, 50/60 Hz (autodetecting) G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

4 Specifications continued Measures: Dimensions: 810 x 550 x 550 (w x d x h) Weight: 28kg Environmental requirements: 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 Open system Direct Reading System Disposable Cuvettes Can use samples from primary tubes Lowest Total cost of Ownership (TCO) Benefit Reagents from any manufacturer can be used after a short application procedure No carryover problem as normally known from flow-cell systems same quality for each test no intermediate manual pipetting steps required Most cost effective solution on the market, if purchase price, consumables and maintenance cost are compared over the live span of the instrument G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

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

6 Features and Benefits continued Measurement System Feature LED technology Patented strange light compensation Benefit Maintenance free, low power consumption, no heat development independent from light environment 20 reading channels fast reading with flexible wavelength selection Linear order of reading channels Positive cuvette detection Temperature controlled more than 500 ABS Modules installed in the field in other OEM systems shortest handling distances maximised process safety optimised reaction environment, especially for kinetic evaluations approved quality Sample & Reagent Carousels Feature Inner carousel can be easily removed Inner carousel cooled (optionally) Outer carousel temp. controlled Positive position control Benefit Overnight refridgeration outside of the system enhanced shelf time of reagents optimised reaction environment maximum process safety G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

7 Competitive Analysis Parameter Eurolyser CCA 180 Vital Selectra 2 Vital Selectra E Throughput 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 positions Windows Software Yes no yes External PC Yes yes yes Test Positions 300, cont. loading 48 Cuvettes, cont. washing yes, 3 predefined positions 48 Cuvettes, cont. 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 calibrators 51 sample and / or calibrators Primary tubes Yes yes yes Sample identification external Barcode reader (optional) external Barcode reader (optional) Reagent cooling optional yes yes Reagent Pre-heating optional yes yes Mixing function yes yes yes 51 sample and / or calibrators external Barcode reader (optional) 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 Automatic Dilution if result out of range Syringes, pick and drop Syringes, pick and drop Syringes, pick and drop yes no no Pre-dilution yes yes yes Reading System 20 channel photometer with up to 20 wavelengths single channel photometer with filter wheel (8 filters max) single channel photometer with filter wheel (8 filters max) Light source LED Quartz Iodine, 20 Watt Quartz Iodine, 20 Watt Lambda Range nm nm 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, V, 50/60Hz no no G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

8 Competitive Analysis continued Parameter Eurolyser CCA 180 Cobas Mira Cobas Mira Plus Throughput 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 memory inbuilt PC with limited 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 calibrators Primary tubes yes yes yes Sample identification external Barcode reader (optional) PosID (optional) Reagent cooling optional optional optional Reagent Pre-heating optional yes yes Mixing function yes yes yes Liquiddetection both probes yes yes PosID (optional) Temp. Control yes, 37 C C C min. reaction volume 150µl 150µl 150µl Multi Reagent Tests 1 3 reagents 1 4 reagents 1 4 reagents Pipetting system Automatic Dilution if result out of range Syringes, pick and drop Syringes, pick and drop Syringes, pick and drop yes yes yes Pre-dilution yes yes yes Reading System 20 channel photometer with up to 20 wavelengths 1 channel photometer with filter wheel (5 pos) Light source LED Xenon Xenon 1 channel photometer with filter wheel (5 pos) Lambda Range nm nm 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, V, 50/60Hz no no G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

9 Competitive Analysis continued Parameter Eurolyser CCA 180 Bayer Express Plus Throughput 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 calibrators Primary tubes yes yes Sample identification external Barcode reader (optional) 40 secondary cups or 20 primary tubes yes 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 Automatic Dilution if result out of range Syringes, pick and drop Syringes, pick and drop yes Pre-dilution yes yes Reading System 20 channel photometer with up to 20 wavelengths Light source LED Halogen Lambda Range nm nm Measures W H D (kg) 810 x 550 x 550 (28) n.a. (77) Autosensing PSU yes, V, 50/60Hz no Halographic Reticle, 1 channel no G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

10 EUROLYSER CCA FAQ General eral 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? 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 ter 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 (!) 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-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 m 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. G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

11 EUROLYSER CCA 180 FAQ continued What is the sample processing capacity or throughput for end points/enzyme tests? Throughput: more than tests/hr. (End Point Mono Liquid) Sample throughput is depending on how many tests are performed per sample. So you have to divide by the number of tests per sample to have the sample throughput. How many test results can be b e 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 Eurolyser is not intended to act as a patient database. Recalling results is not possible. Installation and Maintenance What are the basic pre-installation requirements? Table, mains power connection, a little time. Does the system need any special facility like on-line 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 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 m standards can be used for linear calibration? Up to 10 How many standards can be used for 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. G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

12 EUROLYSER CCA 180 FAQ continued 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 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. G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

13 EUROLYSER CCA 180 FAQ continued How is the temperature re 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? 5-999µl in 1µl steps What is the diluent volume range involved? 5-999µl in 1µl steps What are the technical specifications like carry-over, accuracy, precision etc. for the (a) sample (b) ( reagent 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-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 sible to add new reagents, during analysis for new tests? Yes, instrument will interrupt run upon request. How many reagents are kept under refrigeration if on-board cooling is offered? all 25 positions. (Or 50 positions if nor primary tubes are used) G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

14 EUROLYSER CCA 180 FAQ continued What is the reagent cooling temperature reached, say at an ambient temperature of 23 c? 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 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 3-5ml 3 for low volume tests like 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-heating for sample and reagent probes to bring to 37 c c before analysis? Yes, both probes are heated. What are the 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. G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

15 EUROLYSER CCA 180 FAQ continued 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 and print-out, or only print-out is available? Both, display and printout Is there any 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 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 e 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 G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

16 EUROLYSER CCA 180 FAQ continued What is the linear range of the t photometer ( say to 2.300??) and reproducibility? nm OD nm OD What is the approximate life span of the lamp? The Eurolyser has a LED photometer; contrary to a halogene lamp (average life span hours), the LED system lasts forever (> 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. G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

17 CLINICAL EVALUATION Comparison Instrument : Hitachi 911 Brand of Chemistry : Roche 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 Eurolyser 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 Eurolyser CCA Hitachi Eurolyser CCA Hitachi Eurolyser CCA Hitachi Eurolyser CCA Hitachi Eurolyser CCA Hitachi Eurolyser CCA Hitachi Eurolyser CCA Hitachi Eurolyser CCA Hitachi Eurolyser CCA Hitachi Eurolyser CCA G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

18 Correlation: Cholesterol: Results: Pat. ID Hitachi Eurolyser CCA y = 1,0286x + 1,4643 R 2 = 0, Triglycerides Results: Pat. ID Hitachi Eurolyser CCA y = 1,0381x - 2,3851 R 2 = 0, Glucose Results: Pat. ID Hitachi Eurolyser CCA y = 1,0079x + 5,9655 R 2 = 0, G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

19 Correlation: Total Protein Results: Pat. ID Hitachi Eurolyser CCA y = 0,9601x + 0,3135 R 2 = 0, Uric Acid Results: Pat. ID Hitachi Eurolyser CCA C CA y = 1,0018x + 0,0226 R 2 = 0, Urea Results: Pat. ID Hitachi Eurolyser CCA y = 1,0049x - 1, R 2 = 0, G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

20 Correlation: GGT Results: Pat. ID Hitachi Eurolyser CCA y = 1,0427x - 1,4709 R 2 = 0, GOT Results: Pat. ID Hitachi Eurolyser CCA y = 0,9385x + 3,5133 R 2 = 0, Amylase Results: Pat. ID Hitachi Eurolyser CCA y = 0,9089x + 3,9401 R 2 = 0, G. Bonecker Eurolyser CCA 180 Marketing Manual / Version

21 Correlation: GPT Results: Pat. ID HitachiEurolyser CCA y = 0,9703x + 2, R 2 = 0, 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 Rep Rep Rep Rep Rep Rep Rep SD Avg 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 Rep Rep Rep Rep Rep SD Avg CV % 0.69% 1.67% 6.67% 3.67% 4.78% 1.25% 0.43% 0.60% 1.47% 1.23% 4.78% G. Bonecker Eurolyser CCA 180 Marketing Manual / Version