G4KD
CN.S
S V3
9/1
5
Technical Specifications
Dimensions and WeightAnalyzer H: 18 in, W: 12 in, D: 15 in, Wt: 44 lbsPAK H: 6.75 in, W: 10 in, D: 8 in, Wt: 8 lbs
Sample Volume150 µL BG*/Hct/Lytes**/Glu/Lac/CO-Ox or any subset of the
menu that includes CO-Ox100 µL CO-Ox/tBili only 65 µL BG/Hct/Lytes/Glu/Lac(micro mode) (capillary only)
*BG = pH, pCO2, pO2**Lytes = Na+, K+, Ca++, Cl–
Sample Type Heparinized whole bloodHeparinized plasma (tBili)
Time to ResultsAll tests without CO-Ox: 70 seconds from sample introductionAll tests with CO-Ox: 95 seconds from sample introductionSample capacity: 75 – 600 tests
Measurement MethodologyAmperometric: pO2, Glu, Lac, Creat‡
Potentiometric: pH, pCO2, Na+, K+, Ca++, Cl–, BUN,‡ measured tCO2
‡
Conductivity: HctOptical measurement following chemical lysing of the whole blood sample: CO-Ox, tBili‡ In development. Not currently saleable.
Interface ProtocolsASTM or HL7 enables data transmission to a laboratory, hospital or third-party information management system.
Measured Analytes Analyte Unit Measured Range†
pH n/a 6.80 – 8.00pCO2 mmHg 6 – 150pO2 mmHg 5 – 800Na+ mmol/L 100 – 200K+ mmol/L 0.2 – 20.0Ca++ mmol/L 0.10 – 5.00Cl– mmol/L 40 – 170Glu mg/dL 4 – 750Lac mmol/L 0.3 – 20.0Hct % 15 – 75tHb g/dL 3.0 – 23.0O2Hb % –10.0 – 110.0COHb % –10.0 – 110.0MetHb % –10.0 – 110.0HHb % –10.0 – 110.0tBili mg/dL 0.3 – 40 † The measured ranges reflect actual numeric value ranges the system can report.
Derived (Calculated) Parameters
BE(B)BE(ecf)tHb(c)Ca++ (7.4)Anion gapP/F ratiopAO2
CaO2
CvO2
p50
O2capsO2
sO2(c)HCO3
– stdHCO3
– (c)A-aDO2
paO2/pAO2
RICcO2
a-vDO2
Qsp/Qt (est)Qsp/Qt
Hct(c)
Worldwide LocationsUS, Canada, Latin America and South AmericaBrazil São Paulo +55-11-41543337br.werfen.comCanada Richmond Hill, ON +1-800-552-2025 x6115 instrumentationlaboratory.comColombia Bogotá +57(1)-616-7513Mexico Col. Granada +52-55-5262-1760ildiagnostics.comUruguay Montevideo +5982-481-81-33USA Bedford, MA +1-781-861-0710 instrumentationlaboratory.com
PacificAustralia Artarmon, Sydney +61-02-9098-0200China Shanghai +86-21-66308671Beijing +86-10-59756055cn.werfen.comHong Kong Hong Kong +852-2792-7773cn.werfen.comIndia New Delhi +91-490-29-550in.ilwerfen.comJapan Minato-ku, Tokyo +81-3-5419-1301jp.werfen.comKorea Seoul +82-2-5719246kr.werfen.comThailand Bangkok +66-271-226-28/9
Europe, Middle East, AfricaAustria Vienna +43-1-256-58-000at.werfen.comBenelux Belgium +32-2-7252052The Netherlands +31-76-5480100 benelux.werfen.comCzech Republic Prague +420-246-090-931cz.werfen.comFrance Le Pré Saint Gervais +33-182-30-86-00fr.werfen.comGermany Munich +49-89-909070de.werfen.com
Hungary Budapest +36-1-882-73-10hu.werfen.com Italy Milan +39-02-25221it.werfen.comLithuania Kaunas +370-37-313157lt.werfen.comPoland Warsaw +48-22-336-18-00
Portugal Carnaxide +351-214247312pt.werfen.comRussia Moscow +7-499-124-45-59ru.ilwerfen.com
Spain Barcelona +34-902-20-30-90es.werfen.comUK England +44-1925-810141uk.werfen.comFor all other countries visit international.werfen.com
The Instrumentation Laboratory logo, GEM, Premier, iQM and GEMweb are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies and may be registered in the United States Patent and Trademark Office and in other jurisdictions. All other product names, company names, marks, logos and symbols are trademarks of their respective owners. ©2015 Instrumentation Laboratory. All rights reserved.
For more information, call 1.800.955.9525 or visit instrumentationlaboratory.com.
WerfenCorporate HeadquartersPlaza de Europa, 21–23 08908 L’Hospitalet de Llobregat Barcelona, Spain +34-93-4010101werfen.com
Instrumentation Laboratory Headquarters180 Hartwell Road Bedford, MA 01730 USA +1-781-861-0710 instrumentationlaboratory.com
Advanced, simple and revolutionary.
Automation and innovation at the touch of a button.
Instrumentation Laboratory
Our Passion. Your Results.Driven by our constant passion for innovation, IL has provided the most comprehensive and valuable diagnostic solutions for decades. From the launch of our first instrument, our integrated solutions continue to revolutionize Critical Care testing with more capabilities, more end-to-end automation and more flexibility.
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Now, automation is even better.
Automation and quality care go hand in hand.
Our advanced PLUS technology enables:
• Faster touch-screen responsiveness• Integrated wireless• Remote service
Complements other key features:iQM Automates quality assurance+GEMweb Plus Custom Connectivity Automates information management+Multi-use PAK Automates maintenanceq
Just press GO!
The GEM Family of Critical Care Testing Solutions
GEM Premier Analyzers GEMweb Plus Custom Connectivity
• GEM Premier 4000
• GEM Premier 3500
• GEMweb Plus 400
• GEMweb Plus 300
• GEMweb Plus Customizable Options
• GEMweb
Every member of the GEM Family delivers fast, accurate results, in the lab or at the point-of-care, for the very best patient care.
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Ultimate Flexibility• Standardized platform for the lab and at the point-of-care• Full analyte menu and integrated CO-Oximetry • Accepts a syringe, capillary tube or ampule• Multiple menu and volume PAK configurations
PAK Size
Menu 75 150 300 450 600† Onboard Use-life
Blood Gas, Hct, tHb, O2Hb, HHb, COHb, MetHb, sO2, tBili* 30 days
Blood Gas, Electrolytes, Hct, tHb, O2Hb, HHb, COHb, MetHb, sO2, tBili*
30 days
Blood Gas, Electrolytes, Glu, Lac, Hct, tHb, O2Hb, HHb, COHb, MetHb, sO2, tBili*
30 days
Menus with: Creatinine, BUN and measured tCO2 are in development.
* Cartridges available with or without tBili.† Onboard use-life is 21 days.
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References: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;2:1–7. 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.
2007 Jul;382(1–2):65–70.
“ iQM: a new standard for the future of QC.” – James Westgard, PhD, developer of the ‘Westgard Rules’
How iQM helps to improve patient careiQM continuously ensures the quality of test results with automatic error detection and correction. • Prevents the reporting of erroneous results
• Provides rapid, quality-assured test results with every sample, not just every 8 hours
• Identifies and reduces risks associated with testing processes
iQM: Intelligent Quality ManagementAutomated Continuous Quality Assurance
Continuous quality management vs. traditional QCiQM automatically performs continuous quality checks with every sample to detect any error patterns and correct them immediately. This reduces error detection time from hours to minutes compared with all other methods.
iQM reduces error detection time from hours to minutes.1,2
pH pO2 pCO2 Na+ K+ Ca++ Glu Lac Hct
iQM 3 mins 3 mins 3 mins 17 mins 3 mins 3 mins 11 mins 6 mins 3 mins
Traditional QC (Manual or Auto)
≥ 8 hrs ≥ 8 hrs ≥ 8 hrs ≥ 8 hrs ≥ 8 hrs ≥ 8 hrs ≥ 8 hrs ≥ 8 hrs ≥ 8 hrs
Statistical presentation of an average error detection time with 95% confidence.
Questionable test results
iQM Traditional QC (Manual or Auto)
Error automatically detected, correctedand documented immediately Error undetected
Quality-assured test results
VS.
iQM assures quality continuously All results from 8-hour period require review
0QC IN
8 hrsQC OUT
Time0 ContinuousTime
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FDA-Cleared Intended Use Statement:†
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.††
† Cleared in 2002 for GEM Premier 3000 system and again in 2006 for GEM Premier 4000 system. †† To ensure adherence to a total quality management system, please follow local, state and federal regulatory guidelines.
References: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;2:1–7. 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.
2007 Jul;382(1–2):65–70.
iQM: Intelligent Quality ManagementAutomated Continuous Quality Assurance
How iQM saves time and resourcesIt’s simple. Just insert the self-contained, maintenance-free GEM PAK and iQM does the rest.
• Manages quality in a closed system; everything is self-contained (and no refrigeration necessary)
• Eliminates outside variability
• Eliminates maintenance
• Keeps documentation just a click away
Continuous quality management vs. traditional QCiQM continuously automates nearly all labor- and skill-intensive processes, giving clinical staff more time at the bedside to care for patients. And, by providing continuous automated quality management with no operator intervention, iQM reduces annual labor costs per instrument compared with traditional quality control.
Calculate the savings with iQM.
198 hrs/instrument = staff time saved$4,950/instrument = cost saved
Ask your IL representative for a customized time, resources and storage savings calculation.
Example in a hospital with 8 GEM Premier instruments:198 X 8 = 1,584 staff hrs/year and $4,950 X 8 = $39,600/year
Annual Labor/Instrument*
Positive impact on staff time Positive impact on hospital costs
iQM TraditionalManual QC
TraditionalAuto QC
0total hrs
78 total hrs
198total hrs
iQM TraditionalManual QC
TraditionalAuto QC
$0
$1,950
$4,950
Annual Cost/Instrument*
Manual QC Labor costs for manual QC, troubleshooting and documentation**
Manual troubleshooting
Manual documentation
* Data on file, IL. ** At hourly rate of $25/hr.
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Integrated wireless for seamless communication to the LIS or HIS.
Delivers automated quality assurance and regulatory compliance, while significantly reducing staff time.
Provides intuitive, customizable control of instruments and operators—from any GEM Premier 4000 analyzer or PC The ONLY connectivity software to provide:
• Single-interface simplicity. The only solution to feature the same intuitive interface when accessed on an analyzer or a PC
• Flexible customization. Fully customizable to individual hospital configurations and needs—by individual GEM Premier analyzer, department or globally
• Unprecedented control. System-wide control from any networked PC or GEM Premier, regardless of location
Plus:
• Allows automatic review of analyzer and PAK status
• Alerts operator to replace PAK
• Offers patient history with delta versus previous result with one keystroke
• Consolidates iQM reports, operator competency, audit logs and positive patient ID
GEMweb Plus Custom ConnectivityAutomated Information Management
The only information management system with a single user interface for both analyzers and PCs
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GEMweb Plus 400Everything GEMweb Plus 300 offers AND:
• Automated administration of operator certification exams• Advanced regulatory audit logs for compliance
Home
ICU/ICU1: SUPERVISOR Signed In
ConnectedGEMweb® PlusMenu
Audit Log
CloseShow PDFPDF
ViewClear
Criteria * Required
Patient Record AmendmentsAccess Points:
All
Auditing Operator ID:
All
Patient ID:
All
Patient First Name:
All
Patient Last Name:
All
Date Time Frame:
24 Hours
* Date From:
03/15/2012
* Date To:
03/15/2013
Patient Record Access
System Access
System Configuration Changes
Security and Operator Management
GEMwebWeb-based information management, including:
• Intuitive user interface, accessible from any networked analyzer or PC• Complete operator management• Remote access to analyzer status and control• Remote review of iQM reports
GEMweb Plus 300Everything GEMweb offers AND:
• System-wide control from any analyzer or PC
• Consolidated: - Analyzer/PAK status and control - iQM review - Patient information management
- Sample database - Operator management
• Remote system configurationNEW: • Operator download• eSignature capability• Expanded report menu
ManagementSamplesAnalyzers321
MenuICU/ICU1: SUPERVISOR Signed In
ConnectedGEMweb® Plus
!iQM Active Disconnected Issue Exists
444Tests
27Days
NICU/NICU1Ready
112Tests
25Days
CVOR/CVOR1Ready
215Tests
20Days
ER/ER1Analyzing
437Tests
27Days
ICU/ICU1Ready
438Tests
23Days
PICU/PICU1Aspirating
312Tests
18Days
RT/RT1Ready
515Tests
19Days
Lab/Lab1Present Sample
GEMweb Plus Custom ConnectivityAutomated Information Management
GEMweb Customizable OptionsEverything made easier
• Receipt of ADT transmissions, including positive patient ID verification
• Automated and customizable point-of-care order creation (solicited and unsolicited) and order download
The only information management system with a single user interface for both analyzers and PCs
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PAKs contain all components for patient testing and are ideal for high- and low-volume testing.
Saves time at the point-of-careSelf-contained and simple
• All analytical components in a single, closed system—sensors, CO-Ox optical cell, lysing solution, Process Control Solutions, tubing, waste bag and sampler
• Stored at room temperature
• Easy front-loading
• Replaced every 30 days
Automates the most labor- and skill-intensive processes
• Zero maintenance—just replace the disposable PAK monthly; no additional cartridge handling required
• Only one PAK to inventory and manage, including all solutions, sensors and quality control
• Immediately detects errors—no hands-on troubleshooting required
• Immediately corrects errors—no hands-on corrective actions required
• Regulatory compliance reports generated automatically
GEM PAKAutomated Maintenance
Point-of-Care Testing Automation at the Bedside
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Brings simplicity to the point-of-careStandardized lab-quality results and real-time connectivity for immediate decisions anywhere in the hospital.
GEM PAKAutomated Maintenance
Point-of-Care Testing Automation at the Bedside
* BG, Electrolytes, Metabolites, Hct
CVORImmediate, precise testing
• CO-Oximetry, the most accurate method to measure Hemoglobin, is fully integrated, offering a complete test menu
• Measured Total Hemoglobin not affected by common operative variables, unlike conductive Hematocrit
ICUSaves time and enhances patient care
• Provides complete oxygenation status
• Only cartridge-based system to provide Lactate testing in a single sample
• Comprehensive results in a single sample for fast clinical assessments and better outcomes
• Immediately recalls patient information, enhancing safety
NICUFast, reliable results for tiny patients
• The only cartridge-based system to offer Total Bilirubin
• Automatic Fetal Hemoglobin detection and correction
• Capillary-tube sampling (65 µL)*
• Ideal for nitric oxide therapy
EDRapid, comprehensive testing
• Only cartridge-based system to provide Lactate testing in a single sample
• tHb for triaging trauma-related blood loss
• COHb, MetHb to assist in smoke-inhalation treatment
• Advanced GEMweb Plus Custom Connectivity—intuitive, customized control from any GEM Premier 4000 analyzer or PC
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Just press GO!
The top choice of hospitals worldwide, the GEM Premier 4000 is advanced, simple, revolutionary and is fully automating Critical Care testing. Automated Continuous Quality Assurance
iQM ensures test quality—24 hours a day, seven days a week, providing continuous error detection and correction.
Automated Information Management
GEMweb Plus Custom Connectivity offers true bi-directional communication anywhere—it automates information management and provides system-wide control from any networked PC or GEM Premier 4000.
Automated Maintenance
GEM PAKs contain all testing components, are replaced every 30 days and require no refrigeration. Combined with automated detection, correction and documentation, the most labor- and skill-intensive processes are eliminated, saving significant time.
Automation at the Bedside
Flexible cartridge test volumes and menu options, including a complete CO-Oximetry panel, and standardized, lab-quality results and real-time connectivity for immediate decisions at the POC.
Simple and flexible, it’s the automatic choice for your hospital
29269-15_ILC-105_GEM4K_Brochure_Reprint_MECH2_Interior_V2.indd 9 10/6/15 3:26 PM
11
The GEM Family of Critical Care Testing Solutions
GEM Premier Analyzers GEMweb Plus Custom Connectivity
• GEM Premier 4000
• GEM Premier 3500
• GEMweb Plus 400
• GEMweb Plus 300
• GEMweb Plus Customizable Options
• GEMweb
Every 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 Laboratory
Our Passion. Your Results.Driven by our constant passion for innovation, IL has provided the most comprehensive and valuable diagnostic solutions for decades. From the launch of our first instrument, our integrated solutions continue to revolutionize Critical Care testing with more capabilities, more end-to-end automation and more flexibility.
G4KD
CN.S
S V3
9/1
5
Technical Specifications
Dimensions and WeightAnalyzer H: 18 in, W: 12 in, D: 15 in, Wt: 44 lbsPAK H: 6.75 in, W: 10 in, D: 8 in, Wt: 8 lbs
Sample Volume150 µL BG*/Hct/Lytes**/Glu/Lac/CO-Ox or any subset of the
menu that includes CO-Ox100 µL CO-Ox/tBili only 65 µL BG/Hct/Lytes/Glu/Lac(micro mode) (capillary only)
*BG = pH, pCO2, pO2**Lytes = Na+, K+, Ca++, Cl–
Sample Type Heparinized whole bloodHeparinized plasma (tBili)
Time to ResultsAll tests without CO-Ox: 70 seconds from sample introductionAll tests with CO-Ox: 95 seconds from sample introductionSample capacity: 75 – 600 tests
Measurement MethodologyAmperometric: pO2, Glu, Lac, Creat‡
Potentiometric: pH, pCO2, Na+, K+, Ca++, Cl–, BUN,‡ measured tCO2
‡
Conductivity: HctOptical measurement following chemical lysing of the whole blood sample: CO-Ox, tBili‡ In development. Not currently saleable.
Interface ProtocolsASTM or HL7 enables data transmission to a laboratory, hospital or third-party information management system.
Measured Analytes Analyte Unit Measured Range†
pH n/a 6.80 – 8.00pCO2 mmHg 6 – 150pO2 mmHg 5 – 800Na+ mmol/L 100 – 200K+ mmol/L 0.2 – 20.0Ca++ mmol/L 0.10 – 5.00Cl– mmol/L 40 – 170Glu mg/dL 4 – 750Lac mmol/L 0.3 – 20.0Hct % 15 – 75tHb g/dL 3.0 – 23.0O2Hb % –10.0 – 110.0COHb % –10.0 – 110.0MetHb % –10.0 – 110.0HHb % –10.0 – 110.0tBili mg/dL 0.3 – 40 † The measured ranges reflect actual numeric value ranges the system can report.
Derived (Calculated) Parameters
BE(B)BE(ecf)tHb(c)Ca++ (7.4)Anion gapP/F ratiopAO2
CaO2
CvO2
p50
O2capsO2
sO2(c)HCO3
– stdHCO3
– (c)A-aDO2
paO2/pAO2
RICcO2
a-vDO2
Qsp/Qt (est)Qsp/Qt
Hct(c)
Worldwide LocationsUS, Canada, Latin America and South AmericaBrazil São Paulo +55-11-41543337br.werfen.comCanada Richmond Hill, ON +1-800-552-2025 x6115 instrumentationlaboratory.comColombia Bogotá +57(1)-616-7513Mexico Col. Granada +52-55-5262-1760ildiagnostics.comUruguay Montevideo +5982-481-81-33USA Bedford, MA +1-781-861-0710 instrumentationlaboratory.com
PacificAustralia Artarmon, Sydney +61-02-9098-0200China Shanghai +86-21-66308671Beijing +86-10-59756055cn.werfen.comHong Kong Hong Kong +852-2792-7773cn.werfen.comIndia New Delhi +91-490-29-550in.ilwerfen.comJapan Minato-ku, Tokyo +81-3-5419-1301jp.werfen.comKorea Seoul +82-2-5719246kr.werfen.comThailand Bangkok +66-271-226-28/9
Europe, Middle East, AfricaAustria Vienna +43-1-256-58-000at.werfen.comBenelux Belgium +32-2-7252052The Netherlands +31-76-5480100 benelux.werfen.comCzech Republic Prague +420-246-090-931cz.werfen.comFrance Le Pré Saint Gervais +33-182-30-86-00fr.werfen.comGermany Munich +49-89-909070de.werfen.com
Hungary Budapest +36-1-882-73-10hu.werfen.com Italy Milan +39-02-25221it.werfen.comLithuania Kaunas +370-37-313157lt.werfen.comPoland Warsaw +48-22-336-18-00
Portugal Carnaxide +351-214247312pt.werfen.comRussia Moscow +7-499-124-45-59ru.ilwerfen.com
Spain Barcelona +34-902-20-30-90es.werfen.comUK England +44-1925-810141uk.werfen.comFor all other countries visit international.werfen.com
The Instrumentation Laboratory logo, GEM, Premier, iQM and GEMweb are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies and may be registered in the United States Patent and Trademark Office and in other jurisdictions. All other product names, company names, marks, logos and symbols are trademarks of their respective owners. ©2015 Instrumentation Laboratory. All rights reserved.
For more information, call 1.800.955.9525 or visit instrumentationlaboratory.com.
WerfenCorporate HeadquartersPlaza de Europa, 21–23 08908 L’Hospitalet de Llobregat Barcelona, Spain +34-93-4010101werfen.com
Instrumentation Laboratory Headquarters180 Hartwell Road Bedford, MA 01730 USA +1-781-861-0710 instrumentationlaboratory.com
Advanced, simple and revolutionary.
Automation and innovation at the touch of a button.
Instrumentation Laboratory
Our Passion. Your Results.Driven by our constant passion for innovation, IL has provided the most comprehensive and valuable diagnostic solutions for decades. From the launch of our first instrument, our integrated solutions continue to revolutionize Critical Care testing with more capabilities, more end-to-end automation and more flexibility.
29269-15_ILC-105_GEM4K_Brochure_Reprint_MECH_Covers_Press_V2.indd 1 10/9/15 4:28 PM