technical support training overview. about epocal founded in 2001 by dr. imants lauks inventor of...
TRANSCRIPT
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
epoc™ Web-basedData Manager
Remote workstation
LIS / HIS / EMR
Existing Wi-Fi Access Points
The epoc Wireless System
• 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
epoc Reader Features
OperationAC 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 ElectronicsAmperometric, Potentiometric, Conductimetric
Test Time 45 sec after sample injection
Sensor Electronic Methodologies
AmperometricMeasurement 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
ConductimetricMeasurement of the changes in the electrical conductivity of the solution (electrical resistance of blood).
Hematocrit
epoc Reader
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
HardwareMobile Computer,
Socket SoMo 650-M
SoftwareMicrosoft Windows Mobile (Version 5.0)
EPOC Host Application Software, SP4
Battery Standard Lithium Ion Rechargeable Battery
Operation on BatteryDependent 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
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
• pH• pCO2• pO2• Sodium• Potassium• Ionized Calcium• Glucose• Lactate• Hematocrit
Calculated Values
• 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?