Thermo Scientific Konelab PRIME 60 and Konelab PRIME 30 Fully automated clinical chemistry systems For medium sized laboratories as a stand-alone instrument For high volume testing as a part of automated workcell Konelab PRIME 60: Capacity up to 600 tests/hour depending on workload 2 Konelab PRIME 30: Capacity up to 300 tests/hour depending on workload WORKCELL Automation • • • • 3 Single entry point without pre-sorting Minimizes the need of aliquots Workload balancing Centralized control over the system Continuously expanding test range • Over 80 carefully validated methods for • • • • • • Enzymes Substrates Electrolytes Specific proteins Drugs of Abuse Tests Therapeutic Drug Monitoring • CE marked applications can be complemented with user-definable tests 4 Product overview • Continuous access to samples, reagents and cuvettes • On-board capacity of • • • • 84 routine samples, 6 STAT samples 39 fixed calibrator & control samples 45 reagents in the refrigerated disk 600 cuvette storage positions in PRIME 30, 2100 in PRIME 60 • ISE option: K+, Na+, Cl-, • also Li+ and Ca2+ as optional extra • Interface to a sample track system 5 Operational efficiency • Automated sample pretreatment feature • Automatic sample clot detection • Versatile dilution features • Pre-dilution possibility • Post-dilution with both high and low secondary dilution ratios • Calibrator set made automatically from one stock calibrator for most specific proteins • Different sample types can be analysed at the same time • Important in drug monitoring and therapeutic control • Reflex testing • Saves time and money when finding out the specific test to be run 6 Productive, accurate analysis • User-safe and contamination free measurement • Proven, unique, single use 12-cell cuvette • Cost-effective due to low reaction volume • Only 100 to 250 l • Typically 120 - 200 l • Flexibility and long walk-away time • Cuvette storage enables up to 4 hours walk-away time • Continuous loading access without interrupting testing 7 Advanced design to facilitate routine work • Integrated workstation with touch screen • Enables a working posture with less physical strain • Ideal for limited space • Intuitive graphical user-interface • Provides fast guidance • Makes the analyser easy to use • Available in more than 15 language versions 8 Safe sample handling • Error free sample handling • Automatic sample identification, direct barcode reading and cup/ tube recognition • Bidirectional LIS interface for quick data transfer • Sample tubes • 5, 7 and 10 ml tubes • 0.5 and 2 ml sample cups • • Calibrators and controls • Cooled positions • Possibility to load also into segments 9 Automated sample pretreatment • Saves the operator time, e.g. by automating hemolyzation in HbA1c measurement • Improves quality by minimizing operator variation • Dedicated sample segment for whole blood samples • 10 For one segment hemolyzation takes about 10 min, total turnaround time about 30 min KUSTI - optional module for point-in-space dispensing • Making automatically an aliquot from the primary sample • Equipped with a 92-positions segment • While part of automated workcell requested tests processed autonomously • Sample is sent further to the next analyzer • Minimizing delays on the sample conveyor • Manual sample loading using segments possible at the same time 11 Automatic clot detection • To secure result integrity • Based on pressure differential technology • Both in sample and KUSTI dispensers • The pressure system is calibrated • By making a series of air aspirations, takes appr. 5 seconds, no extra solutions needed • At start up with sample dispenser • At every water wash with KUSTI • Operator is alarmed about clot • All requests are cancelled for that sample • Extra wash is performed for needles 12 Clot detection in sample dispenser • Pressure signals of succesful aspirations on sample dispenser • The pressure dives in an aspiration and returns through a maximum to the rest level 180 200 160 180 140 160 120 Pressure OK 140 100 120 80 • 2 - 15 µl SAMPLE aspirations 60 100 40 80 20 60 0 40 1 17 33 49 65 20 81 97 113 129 145 161 177 193 Time (ms) Clot 0 1 13 21 41 61 81 101 121 141 161 181 201 The clot message is sent if in aspiration maximum fails to reach the rest level or if the end pressure of the curve remains too far below the rest level Clot detection in KUSTI dispenser • Pressure signals of a succesful aspiration • In each sub-aspiration the pressure signal dives to a certain depth, but returns to the rest level between aspirations 140 120 100 80 Reject line 60 40 20 0 1 14 53 105 157 209 261 313 365 417 469 521 573 625 677 729 781 833 885 937 989 1041 1093 1145 1197 1249 1301 1353 • The clot message is sent if in aspiration the pressure dives deeper than in a successful aspiration Convenient reagent handling • Continuous monitoring possibility • Flagging of expired reagents • Determination of vial volume • Estimation of reagent sufficiency • Automatic bottle change-over increases the walk-away time • Possibility to run QC with every new bottle • Used reagent lots can be archived 15 Simultaneous electrolyte measurement • Direct measurement method used in Konelab • Generally considered the most accurate ISE method • Serum, plasma and urine samples • Direct or by manually pre-diluted urine sample • Micro volume electrodes for even smaller sample volumes • Sample volume of only 50 l is sufficient for Na+, K+ and Cl• Additionally 6 l if Li+, Ca 2+ or pH is required • Maintenance-free electrodes • Delivered ready-to-use 16 Proactive support • Minimal user maintenance tasks • About 5 min daily • Start up and Stand by procedures • Maintenance contracts • 6 and 12 months programs 17 Proven technology and experience • Konelab analyzers are supported with • Customized installation • Product training • Product & Application support • After-sales support • Maintenance contracts • Technical service 18 Confirmed quality • Quality system is certified according to the ISO 9001:2000 standard extended with the EN ISO 13485:2003 • Konelab Analyzer systems comply with the requirements of the In Vitro Diagnostic Medical Device Directive (IVDMDD) 19 Key benefits of Konelab analyzers • Easy to use • Clearly laid out, simple to navigate user interface • Automation and analyst efficiency • • • • • Once loaded, the analyzer will run without the assistance of the analyst Automatic dilution of an over range sample Automated sample pretreatment feature Reflex test possibility Clot detection • Different types of samples can be analysed at the same time • Important in drug monitoring and therapeutic control • Productivity • Low reagent volumes -> low cost per test, important in expensive tests • Quick daily start up • Minimal maintenance • User-safe and contamination free analysis • Disposable cuvettes 20 Key benefits of Konelab analyzers • Carefully selected methods and applications • • • • Over 150 CE-marked reagents Optimized kits serve laboratories of all sizes Liquid stable and ready for use System-specific multi-calibrators and controls • Flexible software • Easy method set-up • Special applications to be validated by the customer or distributor • Direct electrolyte measurement • The most accurate ISE method • Maintenance-free electrodes delivered ready-to-use • Full application and technical support 21 One reagent line to be used in all Konelab analyzers -1-Antitrypsin Apolipoprotein A1 and B Ceruloplasmin Complement C3 and C4 C-reactive protein Cystatin C High Sensitive CRP HbA1c Haptoglobin IgA, G and M Lipoprotein (a) Microalbuminuria Myoglobin Orosomucoid Prealbumin Rheumatoid factors Transferrin TDM Electrolytes Na, K, Cl Ca, pH Albumin Antistreptolysin O DoA (DAT) ACP ALP ALT/GPT AST/GOT Amylase Cholinesterase Dibucaine CK CK-MB Gamma-GT -HBDH LDH Lipase Specific Proteins Enzymes Substrates 22 Albumin Total and Direct Bilirubin Carbon Dioxide Calcium Cholesterol HDL and LDL Cholesterol Creatinine Glucose Iron Magnesium Phosphorus Total Protein Triglycerides U/CSF Protein Urea Uric Acid Amphetamine Barbiturates Benzodiazepines Cannabinoids Cocaine Metabolite Opiates Cotinine Ethyl Alcohol Methadone Propoxyphene Carbamazepine Phenobarbital Phenytoin Theophylline Valproic Acid Lithium Konelab PRIME 60 and PRIME 30 Operational efficiency and accurate results! 23