1. Technical Support Training Overview

2. 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

3. The epoc System enterprise Point of Care epoc Reader
epoc Host Mobile Computer
epoc BGEM Test Card
epoc Enterprise Data Manager

4. The epoc Wireless System
Remote workstation
LIS / HIS / EMR
Existing Wi-Fi Access Points
epoc™ Web-based
Data Manager

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. epoc BGEM Test Card

12. 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]

13. 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

14. 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

15. The Next Generation of POC Testing
Questions?