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?