Ins titut für Chem o - und B iosensorik

Automated monitoring vs. single point testing

Around the clock on-line monitoring

Real-time blood analysis

Superior sampling process

Self-Calibration

Improved safety and patient care

BlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Idee und Vorentwicklung im Rahmen eines Projektes des Ministerium für Wirtschaft und Mittelstand, Energie und Verkehr des Landes Nordrhein-Westfalen

Produktentwicklung in Industriekooperation

Ins titut für Chem o - und B iosensorik

Click&Test: T - Connector with adapter

Click&Test: Single use disposable Multi-Sensor-Cartridge

Click&Test: Reusable Console

Click&Test: Monitor Display and Store Data Management

BlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

The Click&Test System consists:

• Fast, safe, simple

• Superior patient management

• Cost effectiveness

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Extracorporal Blood Circle

Standard Solution 1 Standard Solution 2W aste

M1 M2 M3

Monitor and Control Device

Reference ChannelW aste Channel

Reference

Containment Chip

MultianalytContainment Chip

Schematic view of Click&Test

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Operations with cardiopulmonary bypass

Dialysis

Hemofiltration

High volume transfusions

Organ transplantations

postoperative care

Quality control of culture medium

Tissue engineering

Clinical Applications

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Heart surgery centers

Transplantation centers

Intensiv care units (ICU)

Emergency departments

Center of treatment of burnings

Modern tissue culture laboratories

Potential Customers

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Operationen mit der Herz-Lungen-Maschine (HLM) in den deutschen Herzzentren 2000

326 238 253 147

15590

72894

4737 4649

Herzklappenfehler koronare Herzerkrankungen angeborene Herzfehler sonstige Indikation0

10000

60000

70000

80000

Za

hl d

er

Op

era

tion

en

Art der Operation

Operationen mit HLM 2000 Veränderung gegenüber 1999

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

341.179 Operationen mit der Herz-Lungen-Maschine (HLM) in Europa 1999

Deutschland 96.906

Frankreich 43.000

Großbritanien 38.152

Italien 34.000

Spanien 17.000

Niederland 14.150

Belgien 12.492

Polen 14.061

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Containment Technology

Silicon technology

Membrane technology

Microsystem technology

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Containment TechnologyFeatures

Suitable for mass production

Suitable for miniaturisation

Substance-detecting sensor components securely anchored

Simple housing and connection methods using through-contacted sensors

Potential for development as multianalyte sensor and as sensor array

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Containment Technology

Cross-sectional view of a containment sensor

Cross-sectional view of a flow through chip

flow channel

containment

glass

silicon chip

Encapsulation

silicon chip active membrane

active surface of the sensor

gold electrode

•Potentiometric ion sensors

•Amperometric enzyme sensors

•Amperometric microbial sensors

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Potentiometric ion - selective sensors

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

AgSiO2

SiO2

Potentiometric ion - selective sensor

•(a) SEM micrograph showing a containment element with patterned silver electrode for use in potentiometric sensors

•(b) SEM micrograph showing the membrane surface of the potassium sensor

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Containment sensors for medical diagnosticsAnalysis of blood electrolytes

Potassium K+

Calcium iCa2+

pH

Sodium Na+

Hematocrit

SaO2

Hemoglobin

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Containment sensors for medical diagnostics

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Containment sensors for medical diagnostics

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Containment sensors for medical diagnostics

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Containment sensors for medical diagnostics

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Containment sensors for medical diagnostics

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Containment sensors for medical diagnostics

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Containment sensors for medical diagnostics

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

• Segment of the potential-time plot of a three point calibration of a long-term experiment for potassium, sodium, calcium, and pH taken simultaneously in two flow-through cells coupled in series

Measurements and results

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Measurements and results

•Reproducibility and stability of the potential difference between two standard calibration solutions ( U = U [cal.3] - U[cal.1]) during 125h

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Preclinical measurements and results

•Potential-time plot of potassium concentration as measured during an extracorporal animal blood circulation run

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

0 10 20 30 40 50 60

80

120

160

200

240

280

pH - Sensor

Sodium sensor

Potassium sensor

Whole BloodStandard 2

Time in minutes

Standard 1

Sen

sor

sign

al in

mV

Preclinical measurements and results

•Potential-time plot of simultaneous on-line monitoring by a sensor chip integrated with three different sensor elements used in whole blood measurement

Ins titut für Chem o - und B iosensorikBlutmonitorMulti-Sensor-Cartridge-SystemClick&Test

Preclinical measurements and results

•Correlation of K+ measurements of 18 human whole blood samples as obtained by our on-line monitoring system and by the clinical laboratory blood gas/electrolyte analyzer RADIOMETER ABL 625