Technical Support Training Overview
About Epocal • Founded in 2001 by Dr. Imants Lauks v Inventor of Biosensor Technology • Locations Corporate HQ: Ottawa, Ontario, Canada v USA HQ: Horsham, PA (Philadelphia) v • The epoc Blood Analysis System Initial product development completed in Summer 2006 v FDA 510 k clearance for system & analytes in Sept 2006 v • epoc – enterprise point of care
The epoc System • enterprise Point of Care – epoc Reader – epoc Host Mobile Computer – epoc BGEM Test Card – epoc Enterprise Data Manager
The epoc Wireless System Remote workstation LIS / HIS / EMR Existing Wi-Fi Access Points epoc™ Web-based Data Manager
epoc Reader • Features – Communicates bi-directionally with epoc Host via Bluetooth® technology – Automated, internal equivalent QC ü 2 level, electronic QC test upon each connection ü 8 -hour electronic QC check – >8 hrs. since the last electronic QC check – Host disconnects from Reader upon card insertion – LED Indicators ü Amber – battery status indicator ü Green/Red – test status indicator ü Green – power indicator
epoc Reader Features Operation AC Power or Ultralife Lithium Ion Rechargeable Battery 4 hrs to charge Battery Life 50 test cards Stand-By Battery Time 30 hours with fully charged battery Recharge During Use Yes Operating Temperature 15 – 30 C Storage Temperature 0 – 45 C Barometric Pressure 400 -825 mm Hg Sensor Electronics Amperometric, Potentiometric, Conductimetric Test Time 45 sec after sample injection
epoc Reader Sensor Electronic Methodologies Amperometric Measurement of an electrical current used to determine the concentration of the analyte ü p. O 2, Glucose, Lactate Potentiometric Comparison of the unknown voltage with a known voltage from a calibrated potentiometer. ü Ion selective electrodes: Sodium, Potassium, Ionized calcium, p. H, p. CO 2 Conductimetric Measurement of the changes in the electrical conductivity of the solution (electrical resistance of blood). ü Hematocrit
epoc Host Mobile Computer • Features – “We’re wireless!” – Integrated Barcode Scanner – Bi-directional communication with epoc Data Manager & Readers via Wi-Fi and Bluetooth – Customizable epoc Host Software: • Patient test results, parameters, vitals • Respiratory & vent parameters • Reference & critical result ranges • Automated Critical result handling and reporting • Operator / Patient / QC lockouts
epoc Host Mobile Computer Features Hardware Mobile Computer, Socket So. Mo 650 -M Software Microsoft Windows Mobile (Version 5. 0) EPOC Host Application Software, SP 4 Battery Operation on Battery Operating Temperature Operating Humidity Standard Lithium Ion Rechargeable Battery Dependent upon battery and use, approximately 4 hours or 35 tests when connected with Reader. 0 - 50° C 95% RH non-condensing
epoc BGEM Test Card Features – A single-use, self-calibrated test • Quality Assured PRIOR to inserting sample – 92 u. L sample, fresh whole blood • Arterial, venous or capillary • Syringes, evacuated tubes, or EPOC Care-Fill capillary tubes – – Barcoded for improved safety and total quality assurance Room temperature storage for 8 months Incorporates Smart. Card™ technology Multi-Analyte card incorporates PO 2, PCO 2, p. H, Na, K, i. Ca, Hct, Glu, Lac, w/ additional calculated parameters – Cl, BUN, CREA expected end Q 1/Q 2 2011
epoc BGEM Test Card
Test Duration • 165 second calibration cycle • Maximum of 7 ½ minutes to inject sample after completion of calibration • 35 seconds to results after sample injection • 44 seconds for aqueous material [QC]
Test Menu Measured Values Calculated Values • • • • p. H p. CO 2 p. O 2 Sodium Potassium Ionized Calcium Glucose Lactate Hematocrit HCO 3 TCO 2 BE ECF BE B s. O 2 Hb
epoc Enterprise Data Manager (EDM) • Features – A web-based Data Management System – Accessible via any networked computer – Centralized control of decentralized testing – Manages the entire epoc System • Regulatory / Hospital compliance & performance reporting • Operator administration • Reader and Host management & customization by group – Export data to MS Excel • Customize reference & critical result ranges • Easily interfaced to hospital LIS/HIS via industry standard HL 7
The Next Generation of POC Testing • Questions?
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