ROTEM delta when every second counts

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1 Fast diagnosis enables goal-directed haemostasis therapies ROTEM delta when every second counts Easy and safe handling Fast therapeutic decisions Advanced diagnostic safety

2 ROTEM delta System ROTEM delta analyser The ROTEM delta haemostasis analyser measures kinetic changes of the clot elasticity of whole blood samples. It allows quantitative and qualitative assessment by measuring different parameters of the clot status of the blood sample. A comprehensive set of assays permits a differential diagnosis. A comprehensive reagent portfolio provides a differential diagnosis Liquid reagents The differential ROTEM - analysis can be performed at the patient s point of care and provides information about hyperfibrinolysis, dilutional coagulopathies, substitution of fibrinogen, factors or platelets as well as the control of heparin or protamine dosage. in-tem S Fast assessment of clot formation, fibrin polymerisation and fibrinolysis via the intrinsic pathway. r ex-tem ex-tem S Fast assessment of clot formation, fibrin polymerisation and fibrinolysis via the extrinsic pathway. fib-tem fib-tem S ROTEM analysis without platelets; qualitative assessment of fibrinogen status. ap-tem ap-tem S In-vitro fibrinolysis inhibition; fast detection of lysis when compared to EXTEM. hep-tem hep-tem S Data solutions Data transmission in real time to remote screens. ROTEM Connectivity Kit Data transmission to LIS/HIS incl. TEMogram and easy patient query. ROTEM Database Commander Data management of all connected ROTEM -systems on one computer. Information provided in-tem star-tem ROTEM Secure Viewer Single use reagents For specific detection of heparin (compared to INTEM). For recalcification of INTEM and EXTEM. Data solutionsinformation on-time where it is needed All test results are available in numerical and graphical formats. Transfer to LIS/HIS systems or real time transmission to defined PCs is possible. Data protection via integrated password at the user management is ensured.

3 Easy and safe handling The ROTEM delta haemostasis analyser offers multiple functions which enable easy and safe handling. Single use reagents for fast and reliable results Easy operation via touch screen Automated pipette for standardised volumes Integrated learn programme with treatment algorithms and case reports from experts Graphical, step by step instructions simplify the test performance Integrated troubleshooting for fast help Clear search function by separation of patient and control databases Graphical instructions Single use reagents Haas T, Spielmann N, Mauch J, Madjdpour C, Speer O, Schmugge M, Weiss M. Comparison of thromboelastometry (ROTEM ) with standard plasmatic coagulation testing in paediatric surgery. British Journal of Anaesthesia 2012 Jan; 108 (1): Literature Theusinger OM, Nürnberg J, Asmis LM, Seifert B, Spahn DR. Rotation thromboelastometry (ROTEM ) stability and reproducibility over time. Eur J Cardiothorac Surg Mar;37(3): Haas T, Spielmann N, Mauch J, Speer O, Schmugge M, Weiss M. Reproducibility of thrombelastometry (ROTEM ): Point-of-care versus hospital laboratory performance. Scand J Clin Lab Invest Jul;72(4):313-7.

4 Fast therapeutic decisions Schnelle therapeutische Entscheidungen In acute bleeding situations every second counts. Using the ROTEM delta haemostasis analyser fast therapeutic decisions can be made. First results are available within 5 to 10 minutes Easy therapeutic control using previous patient results as overlays 4 channels: differential diagnosis of coagulopathies Fast interpretation by overlay of standard curves over running results Simplified interpretation of results via colour coded TEMograms and highlighted abnormal parameter results ROTEM Data solutions enable a HIS/LIS connection for comprehensive data transfer Mobile use via the ROTEM trolley , alpha ML MCF A10 LI 30,95 Auslenkung Amplitude in in mm mm (Festigkeit) (Firmness) ROTEM analysis using the TEMogram 100 Gerinnungszeit Clotting time CFT CFT ClotGerinnselbildungszeit formation time alpha Alpha-angle alpha Alpha-Winkel A10 Amplitude 10 min. A10 Amplitude 10 after Min. nach MCF Maximum clot firmness Li30 Lysis index 30 min. after MCF Maximale ML Maximum Lysis Gerinnselfestigkeit CFT Time min Zeit in Min. TEMograms of the 4 channels Davenport R, Manson J, De ath H, Platton S, Coates A, Allard S, Hart D, Pearse R, Pasi KJ, Maccallum P, Stanworth S, Brohi K. Functional definition and characterization of acute traumatic coagulopathy. Crit Care Med Dec;39(12): Literature Schöchl H, Maegele M, Solomon C, Görlinger K, Voelckel W. Early and individualized goal-directed therapy for trauma-induced coagulopathy. Scand J Trauma Resusc Emerg Med Feb 24;20(1):15. Görlinger K: Coagulation management during liver transplantation (Gerinnungsmanagement bei Lebertransplantationen). Hämostaseologie 2006; 26 (Suppl. 1): S64-S76.

5 Advanced diagnosis safety The ROTEM delta haemostasis analyser offers the following functions which allow an advanced diagnostic safety. Differential diagnosis by the combination of up to 5 different assays Quality controls: ROTROL N (Level I); ROTROL P (Level II) The barcode scanner prevents the use of wrong or expired reagents Simple patient-id search function for fast and safe real time data transmission Temperature control of the sample assures exact test results The ball bearing stabilised technology of the ROTEMthromboelastometry enables instrument handling in a busy operating area oscillating axis (+- 4,75 ) LED light source ROTEM trolley mirror counterforce spring detector data processor ball bearing sensor pin cuvette + sample temperature controlled cuvette holder clot formation Tem Innovations GmbH ROTEM technology *Application example of ROTEM trolley. Weber CF, Görlinger K, Meiniger D, Herrmann E, Bingold T, Moritz A, Cohn LH, Zacharowski K. Point-of-care testing: A prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology 2012 Sept; 117 (3): Literature Larsen OH, Fenger-Eriksen C, Christiansen K, Ingerslev J, Sørensen B. Diagnostic Performance and Therapeutic Consequence of Thromboelastometry Activated by Kaolin versus a Panel of Specific Reagents. Anesthesiology 2011; 115:

6 ROTEM delta in the clinical setting Complicated bleeding situations can appear intra and post operatively. They can be life-threatening and always require immediate action. A fast differential diagnosis is the basis of a targeted therapy. The ROTEM -analysis offers reliable results within 5-10 minutes and gives information about the efficacy of the therapy. Additionally the ROTEM- analysis enables the monitoring and the adjustment of the therapy. Beside improving patient outcome ROTEM- guided therapy has shown that effective cost savings are possible. The ROTEM delta haemostasis analyser is CE marked, ISO certified and FDA approved. With more than 2000 installations worldwide and over 500 publications the ROTEM technology is proven and accredited in the clinical setting. info@tem-international.de Product folder 9/2012 Tem International GmbH Martin-Kollar-Strasse D Munich Telephone: +49 (0) Fax: +49 (0)

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