Test Assured in Critical Care Diagnostics.Introducing the New GEM Premier 3500: Fast, reliable whole blood testing for your lab and hospital. ETC eM MALMO Deere MeL Ue Nace ULAVR- Tae MSC) Lay GEM Premier 3000, the GEM Premier 3500 offers new capabilities in an enhanced Ethyl mom Mo ec ZOU erm Ce Mes oil BUCe Lo Pe OM UCU COM mel ret LC} Celera tele CRU MLA mR EIRCOM a v SCG re remo ene eMC OSL CECB Rm Reem ela EUR R alee) Calais aa\ Ve M7 nem elt ea eum cues Renate Seen mcr aces most accurate results, every time. M7 SCOT Ul tas lui Rel Ace LOE information management and real-time communication Prete a ea eerie| Cree ey Cee ena con are replaced every 21 foe Ry Perr More versatility and flexibility for faster, easier, more efficient critical care testing. Self-Contained Cartridge PAKS > Non-refrigerated disposable PAKs include all components for patient testing, and are maintenance-free Intuitive Touchscreen > Basic operation learned in minutes—simply press ‘Go! and present sample > Easy-to-use, touchscreen displays and clear, concise menus simplify selection ‘and customization of parameters, and viewing of results GEMweb Connectivity, Enhanced with HL-7 > Allows wireless communication to LIS or HIS » Patient and quality results can be viewed remotely from any networked PC Enhanced Features > Larger sampling area with LED light facilitates sampling > Barcode scanner allows rapid data input iam > Monitors all testing processes and components while providing continuous error detection and correction, 24 hours a day, 7 days a week Complete Test Menu > Customized cartridges include blood gases, electrolytes, metabolites, and hemocrit, with optional CO-Oximetry! and coagulation'? modules Muttiple Cartridge Configurations Offer Flexibility and Cost-Efficiency Se Ce en (weeks) Bc, 5 4 het 5 i 250 3 300 3 0 3 00 2 86, 5 4 yes", 150 3 Re 300 3 Pee) 3 00 2 8 % 3 yes, 150 3 chy 300 3 450 3 00 2 = B= 00,20, eye a + SEMORM potable C-Ocnetr ‘tM PC Ps porate coagutin aayaerjQM—IL's patented, real-time, automated, continuous quality assurance system—helps to ensure optimal test results for enhanced patient care. Consistent Quality Assurance Improved Patient Care > Active, continuous, real-time quality > Automatically and continuously monitors, processing—even during use detects and corrects potential errors > Reduces error detection time when compared > Assesses functionality and initiates and to traditional OC documents corrective action > Ensures optimal quality control protocol > Prevents reporting of results when at all times, regardless of time of day or instrument tolerance limits are exceeded level of operator training > Helps ensure the quality and accuracy > Generates reports for regulatory compliance of each patient result > Continuously monitors and checks all critical components in real time = Sensors ~ Process Control Solutions ~ Failure Pattern Recognition software ~ Process stability Reduces Error Detection Time from Hours to Minutes"? im 3min 3min 33min 17min 3min | 3min 14min min 3 min Bh eBhr 2B hr BBhr BB hr “pte sin ‘Auto OC * Repent average ie toe etc ring sample processing Statistical pesetatin ofa ava rer detction tine with 95% onions [att ahr 2 Tefen 36, MetonralE, Raarsthan Tis Temp, Pomp Vion of ay atesmant or Bond gan lst testing. (ce nia Ate, 38 (2407) 6-78, 2 Westar J, Flin KD, Mansour. Vtiation of 0M Active Process Cont Techn Ponto ae, The Jour af Neo Fett etn a Technol 2002 2 osA published study, analyzing 10,550 patient samples, confirms iQM is not only valid in the research environment, but is also proven in the clinical setting.* Study Details Conducted to clinically validate the performance claims of 10M, as reported by Westgard et al.? 10,550 patient samples Four major teaching institutions Compared iQM-measured QC values to traditional QC results Calculated the average error detection time for each measured analyte Conclusions Study results were published in the peer-reviewed, laboratory reference journal, Clinica Chimica Acta, as follows: “The findings from our study confirm that (a) iQM precision in a clinical setting is comparable to that found in previous studies done in a research setting, (b) the improved precision of control material in iQM is likely because the internal control fluids are sealed and not susceptible to exposure from handling, and (c) the system detects and often corrects errars in specific samples that might not be reported by traditional analytical systems..iM provides quality control results comparable to or better than those obtained with traditional QC methods running on the GEM or other benchtop analyzers...Furthenmore, the error detection capabilities that function on every sample provide an additional safeguard against reporting erroneous results due to clots or interferences.” “ln ma aan Tt, Teg, eg tion qty ane Bnd pa ce ea Chimica Ata 382 (2007) 6570. 2, Werte, Fallon, Manca. Vdtion 0M Rtv Process Cont Techno Paint of Ca, Th Jourel of a Poot ting and Techy, 2003: Vl 2 Mo FDA-Cleared Intended Use ement “iQM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls.” * ter, Ptalogy a Labor Meine eco Won, elope of Weta Re:oa Raley Feet! Curd Duet ng detection and correction of Ces eto ee UR GEMweb connectivity software—integrated information management for complete control...throughout the hospital system. Now wireless. New wireless configuration option provides Request patient demographic information from mobility and greater flexibility for data the HIS/LIS management Connects to HIS/LIS via ASTM or HL-7 protocol Remotely view status for all networked analyzers, in real time Search and view patient and quality results on all networked analyzers from any networked PCUCU aes 0) Technical Specifications Rd Analyzer H: 17.5 in, W: 13 in, D: 11.8 in, Wt: 31.2 lbs re ee ee eR eee UCR 135pL BG", Het cartridges 135pL PON eee vee CN eed ie) cr BG, Lytes, Glu, Lac, Hct cartridges Soe ee eet os CU Heparinized whole blood encores All tests: 85 seconds from sample introduction Coy io acted Oe ee Fem CCL ere Ra aCe OR RY. 60-minute power interrupt allows transport ST Sed Electrode Chamber maintained at 37°C nominal pe tg 3 RS-232 Serial 1/0 Ports, 1 Parallel Printer Port, Seer nee LS Ceres as Complies with IEC 610101, IEC 61326, ISTA, BCLs eed Oe cn ec Hospital or third-party Information System via a wired or wireless connection. Den Ur Analyte Displayed Ranges Resolution pH 6.80 to 7.80 Corn con Err eT on Oey 1 mmHg my BOO ae Kk COO ae cat CST mee cc Eee, ee ET red CCU Saas Het Sas cu Fee eee Cee oun aoa Dee CoE Derived (calculated) Parameters Derived Analytes Displayed Ranges Resolution coos SO aoe come ae ne om 3.0 to 60.0 mmol/L 0.1 mmol/L BE(B) (in vitro) 30.0 to 30.0 mmol/L 0.1 mmol/L ECORI RE ma See ih res rt eae) OSCE mereSimple. Maintenance-free, multi-use, disposable cartridge CCPC esteem tee nace es i CST el ree ene ee B I CeL-(h PU err aU aT) fo) Tels EB aceasta Tem Cuc sua Weg Cee eset mme muster cael results, every time. 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