GEM Premier 5000 with iQM2

GEM Premier 5000 is a state-of-the-art blood gas analyser for point-of-care and laboratory testing, from heparinised whole blood. The system brings a new level of intelligence to acute care diagnostics: it ensures quality continuously, in real time, before, during and after the analysis of each sample — not just at fixed intervals, as traditional quality control (manual or automatic) does.

The entire testing workflow is built around the single-use “all-in-one” GEM PAK cartridge, which contains all the necessary analytical and quality control components. The operator front-loads a single cartridge, with no maintenance and no refrigeration, and results are available in 45 seconds, including the quality checks. The system is designed to adapt to the specific needs of each department — ICU, neonatology, cardiovascular operating room, emergency — through different menu configurations and testing volumes.

iQM2 — active analytical process control

iQM2 is Werfen’s proprietary system for active control of the analytical process. Unlike classic quality control, it performs continuous checks before, during and after each sample, automatically detecting errors, correcting them and documenting them immediately. As a result, the error detection time drops from hours to minutes, and erroneous results no longer end up being reported.

The new IntraSpect™ technology adds a unique capability: it detects transient, sample-specific errors that traditional QC methods miss — such as micro-clots, micro-bubbles and interferences. During the measurement, IntraSpect collects and analyses 15 sensor readings in 15 seconds, identifying deviations in the signal’s shape and slope that indicate an abnormal sample.

A continuous cycle of 5 quality checks

• System Checks — verify the operation of the system’s vital components before each analysis.
• Sensor Checks — run 5 levels of Process Control Solutions (PCS) for real-time error detection.
• IntraSpect Checks — detect transient sample-specific errors (micro-clots, micro-bubbles, interferences).
• Pattern Recognition Checks — identify common errors (including micro-clots and interferences such as thiopental or benzalkonium chloride) and integrate automatic corrective actions.
• PCS Stability Checks — verify the stability of the PCS solutions and the integrity of the cartridge throughout its use.

The 5 PCS solutions are traceable to CLSI and NIST primary standards and are monitored at Medical Decision Levels (MDL), essential for the accuracy of clinical decisions in critical patients — for example, the decision levels for lactate are aligned with the values recommended in the treatment of sepsis.

GEM PAK — advanced simplicity at every point of care

The GEM PAK cartridge automates the most labour-intensive processes and includes all testing components: sensors, the CO-Ox optical cell, the lysing solution, the PCS solutions, the tubing, the waste bag and the sampling system. There is a single cartridge to manage in inventory, with no manual troubleshooting and no corrective actions on the part of the operator.

• Zero maintenance — a single single-use, multi-use cartridge is replaced monthly.
• Safety — the components are self-contained, and blood does not enter the analyser, limiting biohazard exposure for the operator and patient.
• No special requirements — easy front loading, room-temperature storage, no refrigeration.
• 31-day use duration (21 days for the 600-test cartridge) — only 12 cartridges per year at a constant volume of up to 450 samples/month.
• 30 GEM PAK configurations available, ideal for both high and low testing volumes.

Features that simplify operation

• Universal sampling — accepts tubes, syringes or capillaries.
• Illuminated sampling area — ensures correct insertion of the capillary or syringe.
• Barcode reader with motion detection — allows one-handed use.
• Smartcolor status bar — the analyser’s status at a glance.
• “i” button for iQM2 — displays the iQM2 status in real time.
• Custom Quick Start — programmable shortcuts that speed up testing.
• AutoPAK Validation — standardises the time to “ready-to-use” status.

Connectivity — GEMweb® Plus 500

The GEMweb Plus 500 Custom Connectivity software provides complete control over analysers, operators and data, through a simple and intuitive dashboard, accessible from any analyser, PC or tablet.

• Web access from any browser and real-time remote control, without interrupting testing.
• Automatic operator management, with multi-level authorisation and traceability of users and actions.
• A single database for accessing patient samples and historical results.
• Connection to iQM (GEM Premier 3500/4000) and iQM2 (GEM Premier 5000).
• Open connectivity, including to patient monitors, EHR/ADT systems and non-Werfen analysers.

Technical specifications

Sample type	Heparinised whole blood
Time to result	45 seconds (including quality checks)
Test volumes	75, 150, 300, 450, 600 tests/PAK
Cartridge use duration	31 days (21 days for the 600-test PAK)
Storage	Room temperature, without refrigeration
PAK configurations	30 available
Connectivity	GEMweb Plus 500; patient monitors, EHR, ADT

Measured analytes

pH, pCO2, pO2, Na+, K+, Ca++, Cl–, Glucose, Lactate, Haematocrit, tHb, O2Hb, COHb, MetHb, HHb, total bilirubin (tBili), sO2.

Derived (calculated) parameters

BE(B), BE(ecf), tHb(c), Ca++(7.4), Anion gap (AG), P/F ratio, pAO2, CaO2, CvO2, p50, O2cap, sO2(c), O2ct, HCO3– std, TCO2, HCO3–(c), A-aDO2, paO2/pAO2, RI, CcO2, a-vDO2, Qsp/Qt (est), Qsp/Qt, Hct(c).

Available menus

• Blood gases, Hct, tHb, O2Hb, HHb, COHb, MetHb, sO2, tBili
• Blood gases, Electrolytes, Hct, tHb, O2Hb, HHb, COHb, MetHb, sO2, tBili
• Blood gases, Electrolytes, Glucose, Lactate, Hct, tHb, O2Hb, HHb, COHb, MetHb, sO2, tBili

The PAK cartridges are available with or without total bilirubin (tBili).