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Technical Support Training Overview
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About Epocal Founded in 2001 by Dr. Imants Lauks Locations
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
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The epoc System enterprise Point of Care epoc Reader
epoc Host Mobile Computer epoc BGEM Test Card epoc Enterprise Data Manager
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The epoc Wireless System
Remote workstation LIS / HIS / EMR Existing Wi-Fi Access Points epoc™ Web-based Data Manager
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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
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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 mm Hg Sensor Electronics Amperometric, Potentiometric, Conductimetric Test Time 45 sec after sample injection
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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
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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
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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 Standard Lithium Ion Rechargeable Battery Operation on Battery Dependent upon battery and use, approximately 4 hours or 35 tests when connected with Reader. Operating Temperature 0 - 50° C Operating Humidity 95% RH non-condensing
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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
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epoc BGEM Test Card
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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]
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Test Menu Calculated Values HCO3 TCO2 BE ECF BE B sO2 Hb
Measured Values pH pCO2 pO2 Sodium Potassium Ionized Calcium Glucose Lactate Hematocrit Calculated Values HCO3 TCO2 BE ECF BE B sO2 Hb
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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
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The Next Generation of POC Testing
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