engen Laboratory Automation System System Components and Specifications

engen Laboratory Automation System System Components and Specifications

Pre-analytical Modules engen Controller (with TCAutomation Controller and Data Innovations Instrument Manager ) 1 Centralized platform for track functionality ++Monitors system performance ++Controls modules ++Error handling Sample management system ++LIS Connection ++Sample routing based on test requests and results ++Review and release of results ++Manages specimen storage and retrieval ++Real time data back up on second computer Track Design 2 Modular, flexible configuration ++Variety of conveyors and turns adapt to workflow and available space ++Option for multiple, duplicate modules Accommodates varying workload sizes Helps to optimize turnaround time Workload balances between multiple modules ++Track design can be implemented in phases Single Tube Entry Module 3 Provides single piece flow of sample for lean work processes ++Helps to optimize turnaround time ++Maximum throughput is 500 tubes/hour/module ++Multiple modules can be placed strategically Rack Entry/Combined Entry & Exit Module 4 Flexible Sample Entry and/or Exit Options ++Up to six user-definable drawers ++Sample transfer from rack to carrier and from carrier to rack ++Autoreceipt to time stamp sample arrival on track (depends on LIS) ++Pneumatic tube sample rack available ++Module can be positioned at point of arrival or accessioning and/or storage ++Multiple modules can be placed strategically along track based upon optimal workflow 1 2 3 4 5 6 7 8

Centrifuge Module 5 Automates loading and unloading of centrifuge ++3 Robotic Arms ++Load balancing with no balance tube required ++Centrifuge can be disconnected from module and function offline Multiple centrifuges can be placed on track ++System will load balance between centrifuges ++Centrifuges operate independently ++Centrifuges can be programmed to manage different sample types (i.e., chemistry vs. coagulation) User programmable ++Spin Time ++Temperature (range -20 to +40 C) ++G-force ++Batch size (maximum 96 tubes/spin) ++Automatic start after user definable time-out Decapper Flex Module 6 Aliquoter and Labeler Module 7 Automates cap removal process for lower risk of exposure vs. manual process ++Removes wide variety of caps Traditional rubber caps Screw caps ++Manages multiple tube sizes Identifies tube height and diameter From 13 x 75mm to 16 x 100mm ++Alerts user when waste bin is full (approximately 2500 caps) ++Recognizes problematic tubes: tubes without caps, broken tubes, stuck caps Prepares and fills secondary tubes from primary sample tube ++Disposable tips for sample metering ++Sample level and clot detection ++User-defined rules create up to 9 daughter tubes ++Automatic labeling with user-defined fields ++User-defined sorting to exit modules 9 10 11

Analytical Modules VITROS System Bypasses 8 Point in space sampling aspirates directly from track ++Aspirated samples released immediately to track for maximum efficiency ++Process STAT samples by limiting routine queue size + +VITROS Systems can be front loaded while track is in operation + +VITROS Systems remain available for use independent of track ++QC can be performed without interrupting the track Buffer Module 9 ++Samples remain on track awaiting result release ++Automatically rerouted for add-ons, repeats, reflex testing ++Minimizes sample traffic on conveyors during peak times ++Stores extra carriers for entry and/or exit module and centrifuge ++Capacity is 170 tubes Post Analytical Modules Recapper Module 10 Rack Exit Module 11 ++Caps primary sample tubes from 13 x 75mm to 16 x 100mm ++Caps TCA aliquoter secondary tubes ++Universal, plug style cap ++Individual capping for single-tube retrieval from storage ++Capped sample tubes can be decapped by decapper Flexible Exit options ++Up to 6 user-definable drawers ++Sample transfer from carrier to rack ++Sorting to a variety of racks including storage and some manufacturers analyzer racks ++Module can be positioned at point of storage ++Multiple modules can be placed strategically along track based upon optimal workflow ++Communicate rack barcode and storage position to the LIS ++Styrofoam storage racks can be put directly in refrigerator without re-racking Multi-tube Carrier Transfers tube along conveyor to modules ++Embedded Radio Frequency Identification (RFID) chip carries: Sample information STAT status Route to next module ++Barcode information downloaded to chip at entry point ++Minimizes multiple barcode reads on track ++Barcode information verified between barcode and carrier upon exit ++Enables real time sample tracking and routing

engen Workcells A Simple Way to Start Automation 1 2 Key Features 1. Consolidated Workcell 2 VITROS 5,1 FS Chemistry Systems, 2 VITROS 3600 Immunodiagnostic Systems* 3 3. Immunoassay Workcell 2 VITROS 3600 Immunodiagnostic Systems* 2. Integrated Workcell 2 VITROS 5600 Integrated Systems* 4 4. Clinical Chemistry Workcell 2 VITROS 5,1 FS Chemistry Systems engen Systems minimize operator interventions and manual rework by automating: ++ Sample processing ++ Sample transport with intelligent routing ++ Automatic accessioning when sample is placed on the track (upon LIS capability) ++ Rules-based reflex and repeat testing ++ Result verification ++ Sample location storage and retrieval All engen Systems, from workcells to Total Lab Automation (TLA) feature: ++ Single entry point without pre-sorting ++ Workload balancing across instruments and pre-analytical modules ++ Centralized result verification ++ Rules-based routing Linear configuration of Integrated Workcell Performance Powered by engen Select Because every laboratory is different, engen Systems are all about flexibility right down to the software. engen Select offers flexible hardware configurations and flexible setup parameters within the software. Features ++ Pre-defined autoverification rules ++ Flexibility to modify pre-analytical routing + + Supports multiple VITROS Systems on track ++ Universal routing logic including request-based routing, result-based routing and workload balancing ++ Automatic aliquotting and sorting based on LIS requests ++ Automatic sample sorting completed/incompleted samples for storage ++ License options include Thin Client, audio-visual device and bi-directional integration to Ortho Clinical Diagnostics selected QC software Benefits * VITROS 5600 and VITROS 3600 with engen automation are subject to regulatory approval in local markets. ++ Rapid implementation ++ Minimally disruptive upgrades ++ Avoids extra costs and time related to software customization ++ Eliminates multiple LIS interventions and fees ++ Consistent sample turnaround time ++ Minimizes sample retrieval time ++ Minimizes operator interventions and manual sample handling

engen Laboratory Automation System Specification Module Maximum Tube Capacity Maximum Throughput (tubes/hr) Single Tube Entry 140 500 (released to the conveyor) Rack Entry or Rack Entry/Exit Centrifuge (with Hettich Rotanta) Tube Sizes in mm 576 500 13 x 75 to 16 x 100 dependent on rack 4 x 24 tubes/load 400 (depends on spin time) Decapper Flex 600 Bd Vacutainer, Greiner Vacuette, Terumo Venoject I, Terumo Venosafe : 13 x 75, 13 x 100, 16 x 100, Sarstedt Monovette : 13 x 65, 13 x 90, 15 x 75 Aliquoter/Labeler Appx. 200 secondary tubes/hour Perpendicular Bypass (VITROS 5,1 FS Chemistry System) Parallel Bypass (VITROS 5,1 FS Chemistry System, VITROS 3600 Immunodiagnostics System, VITROS 5600 Integrated System) Footprint (H,W,D) in mm Weight in kg 13 x 75 to 16 x 100 1150 x 600 x 790/965 1 145 1900 x 1200 x 325 790/965 1 /1515 2 13 x 75 and/or 13 x 100 1900 x 1200 x 790/965 1 /1375 5 485 Primary: 13 x 75 to 16 x 100 Secondary: 13 x 75 (screw cap type) 1600 x 600 x 790/965 1 /1375 4 205 1900 x 1500 x 790/965 1 /1515 2 475 50 13 x 75 to 16 x 100 1150 x 600/350 3 x 790/965 1 120 30 13 x 75 to 16 x 100 1150 x 600/450 3 x 475/650 1 120 Buffer 170 13 x 75 to 16 x 100 1150 x 600 x 790/965 1 145 Recapper 500 Bd Vacutainer, Greiner Vacuette, Terumo Venoject I, Terumo Venosafe : 13 x 75, 13 x 100, 16 x 100, Sarstedt Monovette : 13 x 65, 13 x 90 Rack Exit 576 (with standard TCA 24-position racks) 400 13 x 75 to 16 x 100 dependent on rack 1600 x 600 x 790/965 1 280 1900 x 1200 x 790/965 1 /1515 2 325 Conveyor 600 W 600 x D 175 19 Conveyor 900 W 900 x D 175 26 Conveyor 1200 W 1200 x D 175 32 Conveyor 1500 W 1500 x D 175 38 Conveyor 1800 W 1800 x D 175 44 Conveyor 2100 W 2100 x D 175 50 Conveyor 2400 W 2400 x D 175 56 U-Turn W 300 x D 175 8 L-Turn W 385 x D 385 20 Internal U-Turn W 600 x D 170 25 T-Turn W 600 x D 385 30 Z-Turn (left) W 600 x D 170/470 1 26 Z-Turn (right) W 600 x D 170/470 1 26 Remark: 1. with conveyor 2. with open drawer 3. width back/front 4. with open waste container 5. with the Centrifuge TCAutomation Operating Environment Supported Barcodes Code 128 Maximum 17 digits Code 39** (with or without check digit) Maximum 17 digits USS Codabar** (with check digit) Maximum 17 digits Interleaved 2 of 5** (with check digit) Maximum 17 digits **Using check digit is strongly recommended. Power Requirements Ambient Temperature Average Noise Output Humidity Power Consumption Operating Conditions 100 240V ±10%, 50 60Hz ±5% (module-specific) 15-32 C <65 db(a) per module 40-80% (non-condensing) 50 W 2000 W Total power consumption will depend on the modules present in each configuration www.orthoclinical.com All trademarks are property of their respective owners. Ortho-Clinical Diagnostics, Inc. 2010 CL11321 OCD9030715 January 2010