Advanced, simple and revolutionary. Automation and innovation/media/il/docs/product/critical... · 2016-07-29 · 2. Toffaletti JG, McDonnell EH, Ramanathan LV, Tolnai J, Templin

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

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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


• 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.

29269-15_ILC-105_GEM4K_Brochure_Reprint_MECH2_Interior_V2.indd 2 10/6/15 3:26 PM

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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.


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


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


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11

The GEM Family of Critical Care Testing Solutions

GEM Premier Analyzers GEMweb Plus Custom Connectivity



• 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.



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.




creo

Documents

Advanced, simple and revolutionary. Automation and innovation/media/il/docs/product/critical... · 2016-07-29 · 2. Toffaletti JG, McDonnell EH, Ramanathan LV, Tolnai J, Templin