BIO-FLASH Limited Release

Transcription

1 1st March / 1BF / MKT BIO-FLASH Limited Release Biokit is pleased to announce the Limited Release of the BIO-FLASH system, together with the first wave of eleven BIO-FLASH reagents in the field of Infectious Diseases (ID). This Limited Release is a sign of our confidence in the high quality experience that this new system can offer to you and your customers. This confidence is not only subjective, it is also supported by the CE mark registrations granted to all the components involved in the project (instrument, consumables, reagents, calibrators and controls). It is essential for Biokit to carefully monitor these first installations of the system in selected markets. Together with the partners involved in this launch, we want to ensure complete understanding of the system and the materials provided to final customers in order to assure a win win situation. We currently have an inventory available for shipping to affiliates and distributors especially chosen for the Limited Release. In order to guarantee first class supply in the future, we ask you to continue communicating any sales expectations, questions or comments that you may have so that we can be ready when the full release starts in few months. For this reason we encourage you to arrange calls through your Area Manager to discuss any situations with logistic implications. All Technical Services and Product Managers trained in our BIO-FLASH ID courses already have copy of the documents and marketing tools to support the Limited Release. BIOKIT S.A. Can Malé, s/n Lliçà d Amunt Barcelona, Spain Tel Fax Converting research into real solutions

2 Documents and marketing tools available: 1. Biokit video presentation 2. Biokit (Werfen) presentation (PPT) 3. BIO-FLASH video presentation 4. Biokit. Milestones in ID (PPT) 5. BIO-FLASH presentations (PPT) 5.1. Instrument Overview 5.2. ID Reagent Menu 5.3. User Training 5.4. User Maintenance 6. Understanding BIO-FLASH Reaction (PPT) 7. TORC, Hepatis and HIV insert sheets (PDF) 8. Library of Applications (TORC, SEROLOGY and Verification kits) 9. Tutorial: How to install applications (TORC and SEROLOGY Hep. and HIV-) 10. VERIFICATION CHECK (Excel) 11. Sample volumes (PPT) 12. Reagents presentation and performance summary (Excell) 13. SALESMAN DOSSIER (Word) 14. CAP TODAY June Automated immunoassay analyzers (PDF) 15. IA-ID Market Description (PPT) 16. BIO-FLASH Marketing Presentation (PPT) 17. ID Market Scenario EDMA (PPT) 18. BIO-FLASH Competitors (PPT) 19. Competitors Menu Study: Diasorin & Biomerieux (PPT) 20. Technical Information TORC and HEP+HIV RUBELLA: disease & tech. characteristics of the reagents (PPT) TOXOPLASMA: disease & tech. characteristics of the reagents (PPT) CMV: disease & tech. characteristics of the reagents (PPT) HBV: disease & tech. characteristics of the reagents (PPT) HCV: disease & tech. characteristics of the reagent (PPT) HIV: disease & tech. characteristics of the reagent (PPT) 21. Informative videos: TORC, Hepatitis and HIV 22. Copy of RGTS CE registration (PPT) 23. BIO-FLASH Brochure & specs (PDF) 24. Biokit Brochure (PDF) 25. BIO-FLASH poster (PDF) 26. MDSS (PDF) 27. BIO-FLASH Service Manual 28. BIO-FLASH. Quick reference guide 29. BIO-FLASH Operator s Manual 30. Technical bulletins (Word) 31. BIO-FLASH: Part list & Consumables 32. BIO-FLASH: Recommended Spare Part List 33. BIO-FLASH ID: Lockout Specs (Word) BIOKIT S.A. Can Malé, s/n Lliçà d Amunt Barcelona, Spain Tel Fax Converting research into real solutions

3 If you have not yet trained your Technical Service and/or Product Manager in the BIO-FLASH ID, let me take this opportunity to recommend you enrol them as soon as possible in the training courses scheduled for this year. Remember that in order to maintain the quality of these courses, the number of places is limited and admission will be by strict order of registration. Please contact Montse Armengol to obtain the registration form. Yours sincerely, Ricard Forns Marketing and Technical Services Director BIOKIT S.A. Can Malé, s/n Lliçà d Amunt Barcelona, Spain Tel Fax Converting research into real solutions

4 Course interest: Please indicate what specific course you would like to attend Course date : Course location: Biokit Barcelona Participant Company Participant Country Name of Participant address Last Name Cellular phone during your stay in Spain Experience level with Lab instrumentation Years of experience Instruments used Beginner Intermediate Advanced Training sessions will be conducted in English It is recommended that each attendant brings a laptop The training administrator will arrange for hotel accommodations when flight confirmation has been provided Attendants are financially responsible for hotel accommodations and expenses INTERESTING ISSUES TO DISCUSS DURING VISIT COMMENTS

5 SOFTWARE Chemiluminescence Analyzer Intuitive operator interface Easy-to-follow pictograms for routine tasks Extremely reduced learning curve Quick view of the run status in real time Multiple accesses to database information Configurable patient report Levey-Jennings QC charts Consumption statistics User-friendly manual, computer based and contextual help Touch screen interface INFECTIOUS DISEASES MENU: Toxo IgG Toxo IgM Rubella IgG Rubella IgM CMV IgG CMV IgM HCV HIV-1+2 HBsAg anti-hbc anti-hbs Under development Syphilis Chagas HTLV HIV Ag/Ab HBeAg anti-hbe HSV I IgG HSV II IgG HSV IgM Lliçà d Amunt - Barcelona - Spain Tel.: (34-93) Fax: (34-93) biokit@biokit.com REGISTERED FIRM /10/08 ed. 4/2011

6 only opened by the instrument when the reagent probe is ready to pipette one of the reagents. The rest of the time it is closed. This reduces reagent evaporation and dust contamination and, together with the refrigeration system, provides excellent on board reagent stability. Reagent cartridges have a barcode which includes the Master Calibration Curve, used for calibrating the entire reagent lot. This Master Calibration Curve together with reagent stability reduces reagent usage and hands-on operation time. 6 Sample Probe: Used to pipette samples and diluents. The sample probe is equipped with a Clot Detection system based on pressure differential technology. This ensures accurate sampling is a fully automated, benchtop, random access and multiparametric immunoassay system. and prevents false negative results due to fibrin clots. The needle also has a Liquid Level Sensor including Crash Detection. Magnetic particle separation with flash chemiluminescent detection delivers exceptional clinical performance, offering immunoassays with high sensitivity and extremely large dynamic ranges. SYSTEM DESCRIPTION 1 Safety Covers: The sample and reagent modules are protected by lockable covers, that increase operation safety and reduce the effect of the external environment on the instrument, minimizing 2 Cuvette Loader Module: The exclusive cuvette loader system can contain up to 280 disposable cuvettes organized in 20 columns with 14 cuvettes per column. These columns are automatically separated into individual cuvettes and transferred into the incubator module. The cuvette loader controls the number of available cuvettes on-board and displays a warning message when the supply is low. New cuvettes can be added to this module at any time. tubes, providing a total capacity of 30 samples on-board. A variety of primary or aliquot sample tubes, cups and false bottom tubes can be accommodated in the rack sectors. The flexibility of the instrument makes it possible to work with STAT, automated rerun, reflex tests and calculated testing minimizing operator handling. The sample rack sectors configuration allows continuous sample loading, which facilitates workflow efficiency. The sample probe is coated with a ceramic compound which, together with the cleaning solution, reduces the carry-over below 0.1 ppm. 7 Reagent Pipettor: Used for aspirating and dispensing intermediate reagents and the reagent with magnetic particles. This probe is also coated with a ceramic compound to prevent carry-over contamination between reagents, and has a Liquid Level Sensor including Crash Detection. 8 Distributor/Incubator: The distributor module provides slots the evaporation of samples and reagents and helping to maintain temperature control. The BIO-FLASH instrument will not operate if any of the access covers remain open. 3 Sample Module: The sample carrousel is designed to hold up to 6 rack sectors, each one capable of accommodating 5 sample 4 Reagent Module: Up to 20 reagent cartridges can be held in the reagent carrousel, which is cooled to 4ºC. for up to 46 reaction cuvettes, and incubates all the reaction steps to 37ºC. The distributor s rotation system ensures a quickchange of the cuvette position between the cuvette loader, MagWash station, dispense positions and Luminometer. The reagent cartridges are carried by the carrousel to designated locations where the reagent pipettor can operate. 9 Magnetic Wash Station: The MagWash station is an arc- The reagent module mixes the innermost vial of the cartridge to ensure homogenization of magnetic particles while the reagent is aspirated. This ensures exceptional precision in result generation. shaped array with 8 wash stations located inside the incubator module. This station carries out the separation of magnetic particles from other reaction liquids. 5 Reagent Cartridges: The innovative reagent cartridge includes 10 Luminometer: The Luminometer receives the processed all necessary reagents in four sealed tubes with a piercing cover. To start using the reagents, simply push the cover, which opens the tube s seal. Once this is done, reagent cartridges are ready to be inserted into the instrument and ready for operation. samples and activates them with trigger reagents to obtain a flash chemiluminescent signal. The measurement device is a photomultiplier tube that translates light into electrical signals. The reagent cartridge cover also has a mobile system that is

7 Specifications Type Operation modes Time to first result Throughput Samples Sample loading Tube type Sample ID Capacity Dilutions Flash chemiluminescence Random access & batch mode STAT function < 30 minutes 64 tests/hour for typical assays Continuous loading Primary tubes of varying sizes; - Tubes: Outside diameter between 10-16mm, lenght between mm - Cup-on-tube and micro cup (1.5 ml) Positive sample identification with barcode; Code 128, Code 39, Codabar (NW7), Interleave 2 of 5 30 positions Sample pre-dilution and post-dilution (re-run) available. Reflex tests. Sampling Probe Specific reagents Reaction cuvettes Washing station Incubation Sample volume Level sense Cleaning Carry over Available Assays Identification Storage temperature On board reagents stability Cuvettes type Cuvettes on board Capacity of washing bottles Incubation temperature From 10µl to 200µl (assay dependent) Capacitance liquid level sensor with clot detection. Internal and external < 0.1 ppm 20 on board reagent cartridges Positive barcode ID On board refrigerated 4ºC. > 2 months for typical assays Disposable cuvettes work stations 5 litres 37ºC ± 0.5ºC Detector Detector Emited light High performance photo multiplier Isoluminol 420 nm Calibration Type Master curve Working curve Calibrators Master curve by test and lot specific Up to 12 points, barcoded Calculated from master curve and 2 calibrators Barcoded vials QC Others Connectivity requirements Power consumption Electrical requirements Instrument size Weight Noise level Ambient conditions Working area dimensions Radiated energy Electromagnetic compatibility (EMC) Levey-Jennings charts Barcoded control vials ASTM compliant RS-232 or TCP-IP with batch and host query, bi-directional 115VAC at 5.5 amps and 230VAC at 2.75 amps VAC with electrical variations of up to ± 10% on the nominal supply and with supply frequencies of Hz Height 50 cm (19.7 inches) Height with Reagent Cover Open 60 cm (23,6 inches) Width 84 cm (33 inches) Depth 61 cm (24 inches) Aprox. 80 Kg (176 Ibs) 60 dba mesured from the front (1meter of distance) Temperature 15ºC - 30ºC Relative humidity 5% - 85% (non-condensing) Barometric range mmhg Width of table > 51cm (20 inches) Height of table 92 cm (36 inches) Lenght of table 150 cm (59 inches) aprox. 600 WATTS (2.050 BTU per hour) Class A Lliçà d Amunt - Barcelona - Spain. Tel.: (34-93) Fax: (34-93) biokit@biokit.com

8 Simple to use No reagent handling: self-contained, ready-to-use, precalibrated reagent cartridges Integrated barcode reader for reagent cartridges and samples Cartridges refrigerated at 4ºC and stable up to more than 2 months onboard Calibrators & controls barcoded Easy rack-loading system accommodates up to 30 samples Windows interface and touchscreen, flat LCD monitor with intuitive prompts Fast and efficient Up to 20 reagent cartridges onboard Available 24 hours/day, 7 days/week Up to 64 tests/hour Time to first result: ~ 30 minutes Random or batch sample processing Continuous sample loading Clot detection STAT function Highly accurate Automated chemiluminiscent technology boosts accuracy and sensitivity Each assay is precalibrated to assure accuracy and standardization High sensitivity (isoluminol) No optical interference Reliability Automatic reflex testing Automatic results validation Westgard multi-rules Levey-Jennings charts Lliçà d Amunt - Barcelona - Spain. Tel.: (34-93) Fax: (34-93) biokit@biokit.com