Transcript Slide 1
Technical Support Training Overview About Epocal • Founded in 2001 by Dr. Imants Lauks Inventor of Biosensor Technology • Locations Corporate HQ: Ottawa, Ontario, Canada USA HQ: Horsham, PA (Philadelphia) • The epoc Blood Analysis System Initial product development completed in Summer 2006 FDA 510k clearance for system & analytes in Sept 2006 • 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 2 level, electronic QC test upon each connection 8-hour electronic QC check – >8 hrs. since the last electronic QC check – Host disconnects from Reader upon card insertion – LED Indicators Amber – battery status indicator Green/Red – test status indicator 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 – 30C 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 pO2, Glucose, Lactate Potentiometric Comparison of the unknown voltage with a known voltage from a calibrated potentiometer. Ion selective electrodes: Sodium, Potassium, Ionized calcium, pH, pCO2 Conductimetric Measurement of the changes in the electrical conductivity of the solution (electrical resistance of blood). 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 SoMo 650-M Software Microsoft Windows Mobile (Version 5.0) EPOC Host Application Software, SP4 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 uL 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 SmartCard™ technology Multi-Analyte card incorporates PO2, PCO2, pH, Na, K, iCa, Hct, Glu, Lac, w/ additional calculated parameters – Cl, BUN, CREA expected end Q1/Q2 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 • • • • • • • • • • • • • • • pH pCO2 pO2 Sodium Potassium Ionized Calcium Glucose Lactate Hematocrit HCO3 TCO2 BE ECF BE B sO2 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 HL7 The Next Generation of POC Testing •Questions?