Gem Premier 4000 Decentralized Brochure - Werfen

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Advanced, simple, and revolutionary.Fully automated atthe touch of a button.INL-267 DECENT 8.5x11.indd 15/10/11 9:14 AM

GEM Premier 4000Brings complete automation to critical caretesting—at the touch of a button.Simply press GO!uuiQM: Automates quality assuranceGEMweb Plus Custom Connectivity:Automates information managementuMulti-use PAK: Automates maintenanceAutomation and quality care go hand in hand.Fully automated maintenance, quality control and information managementhelp to ensure patient safety and enhance patient care.INL-267 DECENT 8.5x11.indd 25/10/11 9:14 AM

Ultimate FlexibilityuStandardized platform for the lab and at the point-of-careuFull analyte menu and integrated CO-OximetryuAccepts a syringe, capillary tube or ampuleuMultiple menu and volume PAK configurationsPAK SizeMenu75150300450600†OnboardUse-lifeBlood Gas, Hct, tHb, O2Hb, HHb,MetHb, sO2, Total Bili*30 daysBlood Gas, Electrolytes, Hct, tHb, O2Hb,HHb, MetHb, sO2, Total Bili*30 daysBlood Gas, Electrolytes, Glu, Lac, Hct, tHb,O2Hb, HHb, MetHb, sO2, Total Bili*30 daysMenus with: Creat, BUN, measured tCO2 are in development.† Onboard use-life is 21 days.* Cartridges available with or without Total Bili.2INL-267 DECENT 8.5x11.indd 35/10/11 9:14 AM

Automated Quality AssuranceiQM: Intelligent Quality ManagementThe most accurate results, every time, for maximum efficiency andenhanced patient care.Automatically monitors all components. Provides continuous error detection and correction.iQM Continuous Model Error automatically detected, correctedand documented immediately Optimal test results ensured0ContinuousTimeTraditional QC (Manual or Auto) Eight-hour Model?!Time0QC IN8 hrsQC OUTTime! Error undetected? Questionable test results (all resultsfrom eight-hour period require review)Reduces Error Detection Time from Hours to Minutes1, 2iQMTraditional QC(Manual or Auto)pHpO2pCO23 mins3 mins3 mins 8 8 8hrshrshrsNa K 17 mins 3 mins 8hrs 8hrsCa GluLacHct3 mins11 mins6 mins3 mins 8 hrs 8 hrs 8 hrs 8 hrsStatistical presentation of an average error detection time with 95% confidence.“ iQM: a new standard for the future of QC.”– James Westgard, PhD, developer of the ‘Westgard Rules’3References:1. Westgard JO, Fallon KD, Mansouri S. Validation of iQM Active Process Control Technology. Point of Care, The Journal of Near-Patient Testing and Technology, 2003: Vol. 2, No. 1.2. Toffaletti JG, McDonnell EH, Ramanathan LV, Tolnai J, Templin R, Pompa L. Validation of a quality assessment for a blood gas and electrolyte testing. Clinica Chimica Acta,382 (2007) 65–70.INL-267 DECENT 8.5x11.indd 45/10/11 9:14 AM

FDA-cleared in 2002 for GEM Premier 3000, and again in 2006 forGEM Premier 4000, iQM is the only quality management systemdesigned to provide continuous monitoring of the analyticalprocess with real-time, automatic error detection, correctionand documentation of all corrective actions, replacing the useof traditional external quality controls.Positive Impact on Staff TimeiQM0 total hrsTraditionalManual QC16.5 total hrsManual Quality ControlManual TroubleshootingTraditionalAuto QCManual Documentation6.5 total hrs0Estimated Labor (hrs/mo/instrument)u Over 16 hours saved monthly20u Over 190 hours saved annuallyThis means:In a hospital with 8 GEM Premier 4000 analyzers, iQM can save over 1,500 hours annuallyIL’s patented iQM and all analyticalcomponents are included inside asingle-component, self-contained PAK.4INL-267 DECENT 8.5x11.indd 55/10/11 9:14 AM

Automated Information ManagementGEMweb Plus Custom ConnectivitySystem-wide control from any networked analyzer or PC, customized for your hospital.The ONLY connectivity software to:PLUS:u Provide a single user-interfaceu Allows automatic review of analyzeru Allow system-wide control from anynetworked PC or GEM Premier 4000u Automate and customize operatorcertification and managementand PAK statusu Alerts operator to replace PAKu Offers patient history with delta versusprevious result with one keystrokeTrue web-based, bi-directionalcommunication, anywhere.5INL-267 DECENT 8.5x11.indd 65/10/11 9:14 AM

GEMwebAutomated, web-based information managementuSingle, graphic user-interfaceuBi-directional operator managementuRemote analyzer review and controluRemote iQM reviewuDemographic queryˇˇ1Menu2 (0)CARDIAC/UNIT1: SUPERVISOR Signed InGEM web Analyzer3SamplesManagementSelect button to lock or unlock the analyteReady450TestspHClCapCO 230DaysNa02/08/2010 14:49:24K HctpO 2Last Activity:- tBiliHHbtHbsO 2O 2 HbGluCOHbLacMetHb LockAnalyzerGEMweb Plus 100Everything GEMweb offers AND:uRemote global/area/analyzer system configurationuConsolidated:- Analyzer status and control- Operator management- iQM review- Patient information managementuSystem-wide sample lookup databaseuHIS and LIS order receiving and processingGEMweb Plus 200Everything GEMweb Plus 100 offers AND:uuˇˇ1Menu2GEM web ays515Tests19Days!Issue Exists (0)ICU/ICU1: SUPERVISOR Signed InGEM web PlusOnExam SettingsAutomated and customizable operator certification,including exams27DaysLab/Lab1Present aysiQM ActiveˇˇOnAnalyzers3444Tests (0)ICU/ICU1: SUPERVISOR Signed InRespTherapyPassing Score (0-100%)*l 80Total Number of Exam Questions: 20Advanced regulatory compliance managementSequential OrderRandom OrderSet the passing score as a percentage.Select ‘Sequential Order ’ or ‘Random Order ’ to set the exam question order.Selecting ‘Random Order ’ will randomly change the order of the questions.*RequiredXCancelOKGEMweb Plus 100 & 200 Customizable OptionsMore functionality, more flexibilityuReceipt of ADT transmissionsuAutomated point-of-care order creation6INL-267 DECENT 8.5x11.indd 75/10/11 9:14 AM

Automated MaintenanceSaves significant staff time and reduces trainingand documentation requirements.GEM PAK – The only single-component, multi-use cartridge on the market.uSelf-contained; includes all testing components: sensors, CO-Ox optical cell,lysing solution, Process Control Solutions, tubing, waste container and sampleruStored at room temperatureuEasy front-loadinguReplaced every 30 daysAutomates the most labor- and skill-intensive processes.uZero maintenance—just replace the disposablePAK monthly; no additional cartridge handling requireduOnly one PAK to inventory and manage, includingall solutions, sensors and quality controluImmediately detects errors—no hands-on troubleshooting requireduImmediately corrects errors—no hands-on corrective actions requireduRegulatory compliance reports generated automaticallyPAKs contain all componentsfor patient testing and are ideal forhigh- and low-volume testing.7INL-267 DECENT 8.5x11.indd 85/10/11 9:14 AM

Automation at the BedsideBringing Simplicity to the Point-of-CareStandardized lab-quality results and real-time connectivity for immediate decisionsanywhere in the hospital.CVORImmediate, precise testinguCO-Oximetry, the most accurate method to measureHemoglobin, is fully integrated, offering a completetest menuuMeasured Total Hemoglobin not affected by commonoperative variables, unlike conductive HematocritICUSaves time and enhances patient careuProvides complete oxygenation statusuOnly cartridge-based system to provide Lactate testingin a single sampleuComprehensive results in a single sample for fastclinical assessments and better outcomesuImmediately recalls patient information, enhancing safetyNICUFast, reliable results for tiny patientsuThe only cartridge-based system to offer Total BilirubinuAutomatic Fetal Hemoglobin detection and correctionuCapillary-tube sampling (65 µL)*uIdeal for nitric oxide therapy; no interference from use of Methylene BlueEDRapid, comprehensive testing**uOnly cartridge-based system to provide Lactate testing in a single sample—key to rapidimplementation of sepsis protocolutHb for triaging trauma-related blood lossuCOHb, MetHb to manage smoke inhalation treatmentuAdvanced GEMweb Plus connectivity—fully integrated, real-time information management*BG, Electrolytes, Metabolites, Hct IINL-267 DECENT 8.5x11.indd 9**Basic Metabolic Panel in development: BUN/Creat and measured tCO285/10/11 9:14 AM

Simple and flexible, it’s theautomatic choice for your hospital.The top choice of hospitals worldwide, the GEM Premier 4000 is advanced, simple,revolutionary and is fully automating critical care testing.Automated Quality AssuranceAutomated MaintenanceiQM ensures test quality—24 hours a day,seven days a week, providing continuouserror detection and correction.GEM PAKs contain all testing components, arereplaced every 30 days and require no refrigeration.Combined with automated detection, correction anddocumentation, the most labor- and skill-intensiveprocesses are eliminated, saving significant time.Automated Information ManagementGEMweb Plus Custom Connectivity offers truebi-directional communication anywhere—itautomates information management and providessystem-wide control from any networked PCor GEM Premier 4000.Automation at the BedsideFlexible cartridge test volumes and menu options,including a complete CO-Oximetry panel, andstandardized, lab-quality results and real-timeconnectivity for immediate decisions at the POC.Just press GO!9INL-267 DECENT 8.5x11.indd 105/10/11 9:14 AM

The GEM Family of Critical Care Testing SolutionsGEM PremierAnalyzersuuGEM Premier 4000GEM Premier 3500GEMweb PlusCustom ConnectivityGEMweb Plus 200GEMweb Plus 100u GEMweb Plus Customizable Optionsu GEMwebGEM ComplementaryProductsuuuuuGEMdrawGEM PCL PlusGEM OPLEvery member of the GEM Family delivers fast, accurate results,in the lab or at the point-of-care, for the very best patient care.Instrumentation LaboratoryOur Passion. Your Results.Driven by our constant passion for innovation, IL has provided the mostcomprehensive and valuable diagnostic solutions for decades. From the launchof our first instrument, our integrated solutions continue to revolutionizecritical care testing with more capabilities, more end-to-end automationand more flexibility.INL-267 DECENT 8.5x11.indd 115/10/11 9:14 AM

Technical SpecificationsDimensions and WeightInterface ProtocolsAnalyzerH: 18 in, W: 12 in, D: 15 in, Wt: 44 lbsPAKH: 6.75 in, W: 10 in, D: 8 in, Wt: 8 lbsASTM or HL7 enables data transmission to a laboratory,hospital or third-party information management system.Measured AnalytesSample Volume150 µL100 µL65 µLBG*/Hct/Lytes**/Glu/Lac/CO-Ox or any subset of themenu that includes CO-OxCO-Ox/Total Bili onlyBG/Hct/Lytes/Glu/Lac(micro mode) (capillary only)BG pH, pCO2, pO2Lytes Na , K , Ca , Cl–***Sample TypeHeparinized whole bloodHeparinized Plasma (Total Bili)Time to ResultsAll tests without CO-Ox: 70 seconds from sample introduction95 seconds from sample introductionAll tests with CO-Ox:75 – 600 testsSample /dLmmol/L%g/dL%%%%mg/dLMeasured Range 6.80 – 8.006 – 1505 – 800100 – 2000.2 – 20.00.10 – 5.0040 – 1704 – 7500.3 – 20.015 – 753.0 – 23.0–10.0 – 110.0–10.0 – 110.0–10.0 – 110.0–10.0 – 110.00.3 – 40 The measured ranges reflect actual numeric value ranges the system can report.Measurement MethodologyAmperometric: pO2, Glu, Lac, Creat‡Potentiometric: pH, pCO2, Na , K , Ca , Cl–,BUN,‡ measured tCO2‡Conductivity:HctOptical measurementfollowing chemicallysing of the wholeblood sample:CO-Ox, Total Bili‡AnalytepHpCO2pO2Na K Ca Cl–GluLacHcttHbO2HbCOHbMetHbHHbTotal BiliBUN‡Creat‡tCO2‡In development. Not currently saleable.Derived (calculated) ParametersBE(B)BE(ecf)tHb(c)Ca (7.4)Anion gapP/F RatiopAO2CaO2CvO2p50O2capsO2sO2(c)HCO3– stdHCO3– (c)A-aDO2paO2/pAO2RICcO2a-vDO2Qsp/Qt (est)Qsp/QtHct(c)Werfen GroupWorldwide LocationsCorporate HeadquartersBarcelona, SpainTel. 34-93-4010101www.werfengroup.comInstrumentation LaboratoryHeadquartersBedford, MATel. 1-781-861-0710www.ilww.comUS, Canada, Latin America andSouth AmericaPacificEurope, Middle East,AfricaIL USABedford, MATel. 1-781-861-0710www.ilus.comWerfen Medical ChinaShanghaiTel. 86-21-32100745Werfen AustriaViennaTel. 43-1-2565800-0BeijingTel. 86 10 5975 6032IL BelgiumZaventemTel. 32-2-7252052www.il-be.comWerfen Medical BrazilSão PauloTel. 55 11 4154 3337IL CanadaRichmond Hill, ONTel. 1-800-552-2025x6115IL MexicoCol. GranadaTel. 52-55-5262-1760www.il-mexico.com.mxIzasa UruguayMontevideoTel. 59-82-4818133Werfen Hong KongHong KongTel. 852-27927773IL IndiaNew DelhiTel. 91-11-25191251IL JapanMinato-ku, TokyoTel. 81-3-5419-1301Werfen Medical KoreaSeoulTel. 82-2-571-9246www.werfenmedical.comComesa CzechPragueTel. 420-2-7816047IL FranceParisTel. 33-1-53338600www.il-france.frIL GermanyMunichTel. 49-89-909070www.il-ger.deIL The NetherlandsBredaTel. 31(0)-76-5480100www.il-nl.comIzasa PortugalCarnaxideTel. 351-21-4247300www.izasa.comComesa HungaryBudapestTel. 36-1-4392910 or 11IL RussiaMoscowTel. 7-495-9823723IL ItalyMilanTel. 39-02-25221www.il-italia.itIzasa SpainBarcelonaTel. 34-93-4010101www.izasa.comIL LithuaniaKaunasTel. 370-37-313157IL UKWarrington, CheshireTel. 44-1925-81-0141www.il-uk.comComesa PolandWarsawTel. 48-22-3361800Instrumentation Laboratory, Comesa and Izasa are companies of Werfen Group.For more information, call 1.800.955.9525or visit www.ilus.com.The Instrumentation Laboratory logo, GEM, Premier, iQM, GEMweb, and GEM PCL aretrademarks of Instrumentation Laboratory Company and/or one of its subsidiaries orparent companies, and may be registered in the United States Patent and TrademarkOffice and in other jurisdictions. All other product names, company names, marks,logos, and symbols are trademarks of their respective owners. 2011 Instrumentation Laboratory. All rights reserved.G4KDCN.SS 05/11INL-267 DECENT 8.5x11.indd 125/10/11 9:14 AM

In a hospital with 8 GEM Premier 4000 analyzers, iQM can save over 1,500 hours annually u Over 16 hours saved monthly u Over 190 hours saved annually FDA-cleared in 2002 for GEM Premier 3000, and again in 2006 for GEM Premier 4000, iQM is the only quality management system designed to provide continuous monitoring of the analytical

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