IFA AUTOMATION BEYOND HUMAN BOUNDARIES HELMED IFA PROCESSOR

IFA AUTOMATION BEYOND HUMAN BOUNDARIES HELMED IFA PROCESSOR

WHAT IS THE HELMED? The HELMED is a fully automated and open immunofluorescence processor capable of performing all IFA steps. It is suitable for Autoimmunity (room temperature) and it is the only system on the market that can process Infectious Serology slides (up to 40 C). This instrument is developed and manufactured in Germany in accordance with the highest manufacturing quality standards. HOW DOES IT SIMPLIFY YOUR WORKFLOW? Place your sample tubes and let the internal barcode reader automatically identify your sample ID. Use your worklist electronically without the need to transcribe long ID numbers. Select up to 4 different tests and include their lot, expiry dates and operator information for full traceability. Alternatively use one test only for large screenings EMA ANA HEp-2 ANA HEp-2 ndna rlks Select which tests you would like to run on each sample, or query the LIS to automatically obtain the tests to be performed on each sample. LIS Load the necessary reagents as indicated in the loading wizard and press run. All IFA steps will be processed automatically including the addition of mounting medium. Dilution Transfer Composite Mounting Medium Addition Export your worklist to the HELPS+ IFA Data Management software and complete the sample classification of your processed slides with a pattern library. Attach microscope images of a well to your sample results. HELPS+ IFA DATA MANAGEMENT SOFTWARE

MAIN FEATURES Easily change between different SAMPLE TUBE SIZES thanks to the already pre-programmed and uniquely barcoded HELMED RACKS. 9 different racks are available so that you can swap between different sample tube sizes. No tools required. Racks are simply held by magnets. 12 mm 13 mm 16 mm 12 mm 13 mm 12 mm 50 mm 100 mm 75 mm HELMED RACK REFERENCE 50 x 12 75 x 12 75 x 13 100 x 12 100 x 13 100 x 16 Sarstedt Microtube Sample numbers 1-50 REF. HEL-3540 REF. HEL-3553 REF. HEL-3013 REF. HEL-3509 REF. HEL-3505 REF. HEL-3512 REF. HEL-3029 REF. HEL-3507 Sample numbers 50-100 REF. HEL-3541 REF. HEL-3554 REF. HEL-3014 REF. HEL-3510 REF. HEL-3506 REF. HEL-3513 - - REF. HEL-3508 Reagent rack - - All of the above included REF. HEL-3542 REF. HEL-3555 REF. HEL-3015 REF. HEL-3517 REF. HEL-3518 REF. HEL-3516 - - REF. HEL-3519 Although programmed and validated to run with AESKUSLIDES yet the system is OPEN and allows almost any SLIDE to be programmed regardless of the manufacturer, including INFECTIOUS SEROLOGY. with incubation steps of 2hrs at 40 C (HELMED HTC Edition recommended for such extreme incubation steps). Optimal compact instrument with high Throughput up to: 20 x slides, 150 x samples, 4 tests per run. Minimal volume use. /Waste bottles are typically refilled/emptied normally once per week. Software available in 12 languages: Insufficient sample volume: skip or refill option. Chinese Czech English French German Greek Hungarian Italian Polish Portuguese Russian Spanish Large conjugate bottle option for large mono-test screenings (20ml conjugate vial allows for one full run with 20 slides). Export worklist to HELPS+ and record reading results electronically. Improved layout features: more detailed volumes information, slide number, printout report, more screen resolutions, sample remarks. Control Designer: share controls amongst your selected tests. Additional serurity: password protection for slide and test designer modules. Increased Temperature control: sample transfer initiates once the system has reached the setpoint temperature. Improved heat distribution in the chamber. Highly relevant for Infectious Serology slides where 37 C incubation steps are required for up to 2hrs. Full traceability of data

WHAT DOES A HELMED BRING TO YOUR LAB? STANDARDIZATION HELMED Provides standarisation eliminating the inconcistency that can be attributed to human intervention and distraction. It improves time management and minimizes transcription errors with the built-in internal barcode reader and LIS interface. (HELMED user, Australia) LET THE HELMED DO THE MANUAL IFA WORK SO THAT YOU CAN FOCUS ON WHAT REALLY MATTERS. Loading is performed in a matter of minutes and hands-on time in IFA processing is eliminated. The IFA experts can concentrate on slide reading. HELMED vs MANUAL 00:00 00:15 00:30 00:45 01:00 01:15 01:30 01:45 02:00 02:15 02:30 HELMED PROCESS TIME MANUAL PROCESS TIME 01:46 02:05 TOTAL PROCESS TIME Same conditions: 16 slides, 54 samples, IFA titration identical runs HELMED PROCESS TIME COMPETITOR PROCESS TIME 2h 32m 5h 16m 00:00:00 01:12:00 02:24:00 03:36:00 04:48:00 06:00:00 Sample BC reading Placing dilution tubes / MTP Software (dilution selection etc.) Sample dilution Transfer & 1st incubation Conjugate addition & incubation Mounting medium addition THROUGHPUT Capacity for 20 slides, 4 different tests and up to 150 samples per run. Although the HELMED is a very compact instrument the throughput is high. See example of the process time comparison between a competitor and the HELMED with the exact same conditions (i.e. samples, slides, dilutions etc.). Main reasons for the time differences between HELMED and competitor instrument: No Barcode reader vs HELMED S Built-in Internal Barcode reader. Use of multiple sample pre-dilution tubes vs use of 2 MTP for pre-dilutions in the HELMED. Needing several unnecessary serial dilutions to reach a final dilution vs needing maximum 2 serial dilutions to reach any final titer (up to 1/25600) in the HELMED. Two needle system vs HELMED s unique 3 needle system (the 3rd retractable needle provides an independent reagent pipetting channel allowing wash and conjugate addition to be performed simultaneously). ELECTRONIC WORKLISTS WITH FULL TRACEABILITY There is no need to fill in so many IFA worksheets (one per slide) and write down manually all patient sample IDs, dilutions etc. The barcode reader and LIS communication enables you to go paperless without the worry of traceability, dilutions etc. HELMED INFECTIOUS SEROLOGY & AUTOIMMUNITY IN ONE SYSTEM IFA s up to 40 C for up to 2hrs per step The HELMED HTC Edition (Humidity & Temperature Controlled) is a special HELMED version that has been designed with new chassis modifications that include tight seals and a deep ring to hold distilled water. This allows to successfully process IFA incubations at high temperature of up to 40 C and 2hrs per step by simulating the right environment of a moist chamber eliminating the risk of sample evaporation. By maintaining the optimum humidity and temperature levels Infectious Serology slides can now be also automated as the substrates are not dried during this demanding process. DEEP RING to be filled with a sponge and distilled water in order to keep humidity during incubation at optimum levels. NEW TIGHT SEALS special chassis modification brings improved H&T distribution in the chamber

STANDARDIZE YOUR IFA ROUTINE TESTING WITH FULL TRACEABILITY 1 LIS 12:15 pm 5 HELPS+ worklist Paperless environment Image pattern library ANA Hep-2 Knowledge database Attach real images to your IFA sample results Select follow-up steps : IFA titration, EIA, BLOT, RIA 12:12 pm 4 FROM YOUR LIS AND BACK TO LIS Paperless environment Electronic worklists Electronic results with pictures No transcription Full traceability Pattern library Cost and time savings 3 2 Electronic worklist 9:00 am Or create a manual worklist and select test manualy if LIS is not available in your lab. 9:10 am IFA Reading (Image capture) LED light source means: 30k hrs without lamp replacements No light intensity variation Optional c-mount camera 11:42 am (for 54 samples, 16 slides with high titrations) Automatic IFA Processing Standardization High throughput Reproducibility AESKUSLIDES THE IFA PRODUCT LINE Simplify your routine autoimmunity sample screening with the AESKUSLIDES. The Immunofluorescence (IFA) product line from AESKU.DIAGNOSTICS is designed to fit in with the lab automation needs HEp-2 cells ndna ANCA Cytoplasmic Jo-1 like Kinetoplast positive panca Ethanol EMA KS/LKS (rat, mouse) HEp-2 cells IgA Endomysium positive AMA like pattern on kidney Nucleoplasm coarse speckled

HELMED TECHNICAL SPECIFICATIONS Sample capacity: IFA: With barcode: up to 120 without barcode: 150 Sample identification: Built-in multi-type barcode reader for sample detection and identification IFA Slide capacity: Up to 20 slides IFA test capacity: Up to 4 different tests with 4 different substrates and 4 different conjugates per slide Samples & reagents support: Customized multi-format extractable racks Slide support: 26.1 x 76.1 mm (25 mm and 26mm slide thickness within the same run) Standard sample rack tube size: 75 mm to 100 mm / 13mm diameter tubes and microtubes (2ml) IFA sample dilution capacity: Free titration ratio programmable from 1:1 to 1:25.600 One step dilution: 1:1 thru 1:160 using a MTP well Two steps dilution: 1:161 thru 1:25.600 using MTP wells Dilution fluid: User choice of wash solution or dedicated diluent solution in the carousel Positions available for IFA sample dilution: 192 (performed in 2x96 MTP) Pippeting station: 3 low carbon stainless steel needles. 2 fixed and one retractable The 3rd retractable needle provides an independent reagent pipetting channel One peristaltic pump for aspiration of fluids One peristaltic pump for slide well and MTP well washing 0ne 50 μl syringe 0ne 1 ml syringe Level detection: Continuous level tracking by Conductivity Precision: CV <3% @ 5 μl CV <1% @ 10 μl Minimum sample volume pick-up: 1 μl Minimum sample volume required: 50 μl Reagents capacity: Modular racks with dynamic allocation of positions Several reagent rack can be combined in the outer ring, each of them with capacity for 16 reagent and controls bottles solutions: 2 different wash solution type: Free slide and well wash programming (well by well wash) Incubator: For slides and MTP programmable from RT to 40 C Software requirements: PC (not included) with 32 & 64 bits compatible processor. Runs on Windows Vista, 2000 & XP, Windows 7 PC communication port: Bidirectional USB LIS link: Uni-directional. HELMED can query LIS to automatically select test & dilution Conforms to ASTM standards Bi-directional with the HELPS+ IFA data management software Modularity: Up to 3 HELMED systems controlled by a single PC Programming: User-friendly software interface including an intuitive easy to use slide & test designer that supports different slide thickness, different well formats, multiple substrates in the same slide, multiple sample dispensing points and multiple number of well rows within the same slide Certifications: CE mark and FDA approved Power consumption: Without incubator: 50 Watt max. With incubator: 250 Watt max. Power supply: Input: 100-240 Volt, 50-60 Hz Dimensions: 57cm x 62cm x 75cm Instrument weight: 25 kg HELMED INSTRUMENT MODELS / APPLICATION Autoimmunity Infectious Serology (short incubation steps) Infectious Serology (long incubation steps) HELMED Classic (REF. HEL-1000) HELMED Classic (REF. HEL-1000) + Incubator ring (REF. HEL-3511) HELMED HTC Edition (REF. HEL-1600) VERSION 003: 2011-09-14 AESKU SYSTEMS THE DIAGNOSTIC AUTOMATION COMPANY AESKU.SYSTEMS GmbH & Co. KG MIKROFORUM RING 3 55234 WENDELSHEIM GERMANY TEL: +49-6734-96270 FAX: +49-6734-9627-27 SALES@AESKU.COM WWW.AESKU-SYSTEMS.COM