Acute Care Diagnostics

The Intelligent Analyzer.

Assuring quality before, during and after sample
analysis­—for improved patient care.
 Improving patient c
Now that’s intellige
With the GEM Premier 5000 system:*
iQM2 provides real-time assurance
All-in-one, multi-use GEM PAK
offers advanced simplicity
GEMweb® Plus 500 Custom Connectivity
allows complete management
In the lab and at the point of care

*Not available in all countries.

2
care and efficiency.
ent.
Real-time quality assurance, everywhere
New iQM2 with IntraSpect™ technology provides intelligent analyzing—automated
quality assurance with every sample, continuously and in real time, unlike
traditional (auto or manual) quality control (QC) offerings.
Real-time detection
iQM2 performs continuous checks—before, during
and after every sample.
Immediate, automatic correction
Automatic documentation

Advanced simplicity, anywhere

• Self-contained GEM PAKs
• Available in different menu and test-volume configurations
• Allow ultimate flexibility for the needs of specific units
(e.g., ICU, NICU, CVOR, ED)
• 31-days† use-life and require no refrigeration
†
21-day onboard use-life for 600-test PAK.

30 different GEM PAK configurations available. 3

 iQM2: Real-time detection, correction and documentation
• Error detection reduced from hours to minutes
• A complete picture of quality for each and every sample
• Designed to mitigate risks in all phases of testing, from pre-analytical through post-analytical

iQM2 VS. Manual or Auto QC

Error automatically detected, corrected

and documented, immediately Error undetected

Quality-assured test results Questionable test results

0 Time Continuous 0 Time 8 hrs

QC IN QC OUT

iQM2 assures quality continuously All results from 8-hour period require review

Reduces error detection time from hours to minutes1,2 and detects transient sample-specific errors
that traditional QC methods miss.
pH pO2 pCO2 Na+ K+ Ca++ Cl- Glu Lac Hct tHb tBili
iQM2* (mins) 2 2 2 4.1 2 2 2 16.8 2 2 2 2
Traditional QC
≥8 hrs
(manual or auto)
Statistical presentation of an average error detection time with 95% confidence.

Automated, real-time assurance helps ensure accurate results with every sample
• Provides caregivers more time at the bedside
• Fast and quality-assured test results allow for immediate patient management decisions
• Eliminates unnecessary retesting, for higher patient and staff satisfaction

* Together with James Westgard, PhD, Instrumentation Laboratory established the methodology for optimizing high probability of error detection
and low probability of false rejection of drift limits. Method performance, in terms of mean and Standard Deviation, of measured Process Control
Solutions (PCS) values were obtained from the data of 276 GEM PAK cartridges used in Proof-of-Performance and external studies for the
GEM Premier 5000 analyzer.
4
How is it possible?
• iQM2 functions within a stable, closed analytical system
- Eliminates outside variables
- Ensures errors are known and limited
• Identifies errors through patented Pattern Recognition software
- Pattern Recognition is at the heart of iQM2 functionality
- Possible only with a stable, closed analytical system to which the user cannot introduce change
• Analyzes 5 levels of PCSs continuously to confirm sensor and PAK performance

All-in-one, multi-use GEM PAK

PCS E PCS C

PCS B PCS D PCS A Lysing

solution
Sensor card Waste bag Reference
solution

CO-Ox
optical cell

PAK contains all components

required for sample testing.

Continuous monitoring through 5 PCSs at Medical Decision Levels (MDL)

• PCSs are traceable to Clinical & Laboratory Standards Institute (CLSI) and National Institute
of Standards and Technology (NIST) primary standards
• Each PCS follows the same pathway as a patient sample and serves a specific function
in the iQM2 process
• Established target values monitor MDLs and ensure accuracy of results
• Monitoring MDLs is essential to ensure accuracy in clinical decisions, particularly in critically
ill patients (e.g., lactate MDL align with recommended values for treatment of sepsis)

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 Only iQM2 assures the integrity of every
sample in real time
The only continuous quality management system that checks sample integrity before,
during and after every sample analysis.
• Features patented Pattern Recognition technology in a single-cartridge, stable, closed system
• Auto-detects transient errors during sample analysis that other QC methods could miss
• Auto-documents all errors and corrections
• Generates operator- and sample quality-specific reports to help managers proactively support
quality improvement initiatives*
*Available through GEMweb Plus 500 Custom Connectivity.

Only iQM2 conducts a continuous cycle of 5 quality checks—more than any other blood gas system

Sensor
Checks
System
Only iQM2 has IntraSpect technology
Checks
Detects sample-specific errors during sample
measurement that traditional QC methods
IntraSpect
could miss (e.g., micro-clots, micro-bubbles,
Checks
interferences). If missed, these errors may affect
PCS current or future sample integrity.
Stability
Checks Pattern
Recognition
Checks

Quality management with every second of analysis: iQM2 in real time

System System IntraSpect During Sample

Sensor Checks Pattern Checks
Checks Checks Technology IntraSpect Checks
Sensor reading (mV)

15 checks in
15 seconds
PCS B
(Confirmed
corrective action)
PCS B
(Baseline)
PCS B
(Baseline) PCS A
(Confirmed
PCS B corrective action)
(Below baseline) PCS S
45 125 (Above baseline) PCS A
(Baseline)

Sample Reaction Sample iQM2 sensor check iQM2 corrective actions

aspiration stabilizer measurement period (post sample measurement) to resolve errors

Time (seconds)

6
Only iQM2 offers complete automation
of sample quality management
Performs auto-detection, -correction and -documentation, plus sample-handling reports, tailored
training programs and certification—uniquely improve quality and management.*
*Reports available through GEMweb Plus 500 Custom Connectivity.

1 Real-time error detection 2 Real-time auto-detection and

-correction of transient errors 3 Auto-documentation of
corrective actions applied

Sample handling
reports traceable
to operator or
clinical setting
(from GEMweb Plus 500
Custom Connectivity)

FDA-cleared technology
“ iQM2 manages the quality control process, replacing external quality control.”
— US Food and Drug Administration

7
 GEM PAK: Advanced simplicity at every point of care
Automates the most labor- and skill-intensive processes.
• Zero maintenance—just replace the disposable, all-in-one, multi-use PAK monthly;
no additional cartridge-handling required
- Includes all testing components: sensors, CO-Ox optical cell, lysing solution,
PCSs, tubing, waste bag and sampler
- Only 1 PAK to inventory and manage
- No hands-on troubleshooting or corrective actions required
• Ensures patient and operator safety
- All components are self-contained, limiting operator biohazard exposure
- No blood enters the analyzer, limiting infection exposure for patient and operator
• Ultimate simplicity—no special requirements
- Easy front-loading
- Room-temperature storage; no refrigeration required
- Replaced every 31 days—only 12 PAKs per year*
- Ideal for high- and low-volume testing

Annual Cartridge Utilization Comparison†

All-in-one, multi-use cartridge (room temp) ≈ 60/year

Solution cartridge

Sensor cartridge

QC cartridge
≈ 40/year

12/year

2-cartridge 3-cartridge
system system

*Assumes constant test volume of 450 samples/month or less.

†
 ased on 1 analyzer with annual sample volume ≈ 4,800
B
and QC requirement of 3 times/day. Data on file, IL.
Requires refrigeration.

GEM PAK contains all analytical and

quality control components.
8
Management and compliance simplified
GEMweb Plus 500 Custom Connectivity provides customizable connectivity and automated functionality
for complete control of analyzers, operators and data oversight.

Simple, intuitive dashboard, accessible from any analyzer, PC or tablet.

Simplify POCT Centralize POCT

• Simple web access from any browser • Single unified database to access patient
• Optimized interface for access from analyzer samples and historical results
and tablet devices • Data connection to iQM on GEM Premier 3500/
• Easy at-a-glance dashboard 4000 and GEM Premier ChemSTAT™ systems
• Real-time remote management of analyzer • Data connection to iQM2 on GEM Premier
configuration without testing interruption 5000 systems
• Total automated management of operators with • Customizable to multiple connection types,
multi-level authorization and traceability of users, including patient monitors, HIS/LIS and ADT
actions and competence • Open connectivity, including select non-IL
analyzers‡

LIS = Laboratory Information System • HIS = Hospital Information System • ADT = Admission, Discharge, Transfer • POCT = Point-Of-Care Testing
Contact your local Werfen representative for information on non-IL device connection details and availability.
‡

9
 What’s different about the GEM Premier 5000 system?

Advanced Simplicity
outside

Custom Quick Smartcolor status bar

Start sampling Analyzer status at a glance
Programmed shortcuts
expedite testing Fast time to result
45 seconds including
Illuminated quality checks
sampling area
i-button for iQM2
Ensures proper capillary
Conveys real-time
or syringe insertion
iQM2 status

Universal sampling
Accepts tubes, syringes
Motion-detection
or capillaries
barcode reader
Enables one-hand use

Real-Time Assurance
inside
with IntraSpect technology
Provides a complete picture of quality
for each sample

AutoPAK Validation
Standardizes time-to-ready state

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Improve patient care and efficiency
Improved patient care Improved efficiency
• Rapid, quality-assured test results with • Automates analyzer and operator management
every sample, not just every 8 hours • Manages quality in self-contained GEM PAKs
• Identifies and reduces risks associated • Eliminates outside variability
with testing processes before, during and
• Eliminates maintenance
after every sample
• Menu- and volume-specific GEM PAKs allow
• Prevents the reporting of erroneous results
customization tailored to unit needs
• Enables staff to spend less time maintaining/
• Allows system-wide control from any analyzer or PC
troubleshooting and more time at the
patient’s bedside • Keeps documentation just a click away

Ask your IL representative for a customized

time, resource and savings calculation.

A complete solution for improved patient care and efficiency.

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Technical Specifications
Quantitative Measured Derived (Calculated) Parameters
Analytes
BE(B) pAO2 O2ct RI
Analyte Unit
BE(ecf) CaO2 HCO3– std CcO2
pH n/a
pCO2 mmHg tHb(c) CvO2 TCO2 a-vDO2
pO2 mmHg Ca++ (7.4) p50 HCO3– (c) Qsp/Qt (est)
Na+ mmol/L Anion gap (AG) O2cap A-aDO2 Qsp/Qt
K+ mmol/L sO2(c) paO2/pAO2
P/F ratio Hct(c)
Ca++ mmol/L
Cl – mmol/L Flexible Customization
Glu mg/dL
Lac mmol/L Test volumes: 75, 150, 300, 450, 600†
Hct %
tHb g/dL Menu
O2Hb % Blood Gas, Hct, tHb, O2Hb, HHb, COHb, MetHb, sO2, tBili‡
COHb %
MetHb % Blood Gas, Electrolytes, Hct, tHb, O2Hb, HHb, COHb, MetHb, sO2, tBili‡
HHb %
Blood Gas, Electrolytes, Glu, Lac, Hct, tHb, O2Hb, HHb, COHb, MetHb, sO2, tBili‡
tBili mg/dL
sO2* % †
Onboard use-life is 31-days, except 600-test PAK, which is 21-days.
‡
PAKs available with or without tBili.
*sO2 = O2Hb/O2Hb+HHb.

Real-time assurance and advanced simplicity. Now that’s intelligent.

1. Westgard JO, et al. Validation of iQM active process control technology. Point Care. 2003;2:1–7.
2. Toffaletti JG, et al. Validation of a quality assessment of blood gas and electrolyte testing. Clin Chim Acta. 2007;382:65–70.

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