a cost-effective point of care solution for the entire healthcare enterprise1

November 20101. A Patient-centred Approach. June 2009 Advance For Respiratory Care & Sleep Medicine

epoc® blood analysis:

Contents:

• System components• Test card analytes• Features and benefits• Sample requirements• How to perform a test• Wireless capabilities

• Operational specifications

• QC requirements• Navigating through the

reader screens• Quality Controls

epoc® System

• epoc® Host Mobile Computer

• epoc® Reader

• epoc® BGEM Test Card

epoc® System:

epoc® Data Manager (server-based)

epoc® Host Components

•Touch screen for navigation, using stylus•Barcode scanner•Battery-powered for portability

epoc® Test Cards: Smartcard Technology

TEST CARD - BOTTOM

Measurement region

Sensor module: sensor surface

valve

Blood waste chamber

Sealed calibrator reservoir

Sample entry port

TEST CARD - TOP

Sensor module: contact surface

Test Panel type

Bar Code

epoc® BGEM Test Card Analytes

Test Menu – Calculated Values

Test Cards

• Easy to use• Room temperature storage• ~92uL WB sample• Integrated calibration and quality checks• Results in about 30 seconds after patient sample addition• Bar-coded for error-free panel identification, lot number,

expiry and inventory records• 12 analyte capacity on one test card

epoc® Reader Components

• Host:• Integrated, modular barcode scanner

• Wireless Communication - Bi-directional communication with epoc Data Manager &

Readers via Wi-Fi and Bluetooth

• Flexible epoc Host Software:

–Reference and critical ranges by sample type

–Respiratory and vent parameters

–Automated Critical result handling

–Automated Reporting (read back)

–Operator / Patient / QC lockouts

Features

• Reader:• Patient test time of ~30 seconds • Automated, internal equivalent QC• No maintenance• Offers portable or fixed functionality • A/C Power or Rechargeable Battery• Sensor electronics:

• Amperometric- measures current• Conductometric- measures conductivity• Potentiometric- measures voltage

• Bluetooth technology built-in

Features

• epoc Data Management (EDM) software:• Web-based (accessible via any network)

• Manages the entire epoc system (reports, inventory management, can be interfaced)

Features

Sample requirements

• >92 µL sample (non-volumetric)• Whole blood

• Arterial, venous, capillary

• Syringes or evacuated tubes for sample collection• Evacuated tubes not recommended for ABGs

• Without anticoagulant or with lithium, sodium, or balanced heparin

• Must use balanced heparin if analyzing iCa

• epoc Care-Fill capillary tubes with balanced heparin (90 µL)

epoc® Test Process:• Scan operator ID and enter password• Insert test card into reader to start calibration (165 sec)• Data entry (scan patient ID, enter patient temp, vent data,

etc.)• Collect blood sample (whole blood from arterial, venous or

capillary sources)• Introduce sample into card (within 5 min of calibration)• View result (after 30-second test time)• Transmit result to EDM and LIS via WiFi (1-2 seconds)

epoc® Wireless Communication

EPOC™ Web-basedData Manager

Remote workstation

LIS / HIS Existing Wi-Fi Access Points

Operational Specifications

• Operation: AC or rechargeable battery• Operating temperature: 15° to 30° C• Relative humidity: 85% non-condensing• Barometric pressure: 400 – 825 mmHg• Operation on fully-charged battery: ~50

cards• Time to recharge Reader: ~4 hours

QC requirements

• Verification of Newly Received Test Cards• Cards shipped to Australia with temperature monitors

• Verification of Reader Performance• When a connection between the Reader and the

Host is established, an electronic self-check is performed.

• If the connection is still established after 8 hours, the Host will disconnect from the Reader. Upon reconnect, another self-check will be performed.

• Every device is calibrated prior to specimen testing, eliminating the need for daily controls.

• External controls are run when a new lot is started and every 30 days thereafter or as required.

Navigating through the Reader Screens

Log In and Start Up Screens

• Start Up Screen –upon reset of Host (initiates program, reads files & configures software)

Main Reader Screen

• ‘Lock’ icon (dedicated readers always listed)• EDM Sync appears only when Host configured to EDM (exchange info)

Indicators

Navigation

• Lightly press stylus on Reader icon or list for menu

• Tap for selection

Reader Screen

• Print not enabled during test• Save button enabled after test complete. Info entered after test saved.• Close Reader connection button – cancel test and close connection

epoc® Host Application User Interface

• Tool bar (Bottom of screen)• Screens (Bottom – Connected Readers + Open Test Record)• Multiple Pages (Upper left- Tabs. Greyed out=Not for Use)

Test Pages

•2nd ID•Hemodilution (hematocrit correction)

•Sample (Unknown, arterial, venous, mixed venous, cord, capillary)

•Temp (patient body temp for pH, pCO2 & pO2 corrected values)

•Test Selection (Select all, Clear all, Gases, Electrolytes)

•Test in Progress (progress bar)•Test Results (Measured, Calculated,Corrected)

Additional Test Information Pages

Additional Test Information Pages cont.

Screens when Running a Patient Sample

Calibration process takes approx. 165 secs

Screens when Running a Patient Sample cont.

Timing of Sample Introduction

• After calibration, message displayed to insert sample• Bar indicates time remaining• Sample must be introduced within 5mins

Screens when Running a Patient Sample cont.

Critical Values Action

• Reporting of critical range failure

• On screen at the time of event

• Simple drop-down menu• Simplifies reporting• Assures compliance• Unique feature• Requested by customer

Basis for epoc® Measurements

Potentiometric – Measures voltage• Ion selective electrodes

• Sodium• Potassium• Ionized calcium• pH• pCO2

• Nernst equation is used to convert the voltage into the assay values

• epoc measures either current, voltage, or conductance

Amperometric – Measures current• pO2• Glucose

Conductometric – Measures conductivity• Hematocrit

Quality Controls

Overview• Reader/Host Quality Controls

Barcode Scanner

Thermal System

Operating Environment

iQC

• Test Card Quality ControlsCard Temperature Monitors

Verification of card shipment

• External Liquid Quality Controls• What QCs do I run

• How often

• How to run controls

36

Reader/Host Quality Control

Barcode Scanner

Section 5.12: Barcode Scanner 37

Reader/Host Quality Control

Thermal System

Section 5.13: Thermal System 38

Reader/Host Quality Controls

Operating Environment• Temperature

Internal ambient temperature monitor

15°C – 30°C

• Atmospheric pressure

Internal barometric pressure sensor400 – 825 mmHg

• Relative humidity

Electronic QC checks leakage current

Humidity must be <85% at 30°C

Section 5.14: Operating Environment 39

Reader/Host Quality Controls

3 phases of Internal QC testing (iQC)

• InitialisationPerformed upon connection and at start of test

before calibration

• In-CalibrationPerformed after the calibrator is delivered to the

sensor array

•During Sample MeasurementMonitor procedure and sample integrity

Section 11.6.2: Overview of epoc System Internal QC (iQC) 40

Test Card Quality Controls

Section 4.2.2: Shipping Controls as shipped from Canada. 41

Card Temperature Monitors

External Liquid Quality Controls

Verification of Card Shipment

From each lot analyse 2 levels of fluid controls in duplicate on any verified reader.

Section 9.2.1: Verification of newly Received Test Cards 42

External Liquid Quality Controls

Control Fluids•Bio-Rad Liquichek Blood Gas Plus EGL

• Level 1 and Level 3• Used for BGEM

•Eurotrol BGEM• Level 1 and Level 3• Used for BGEM

•Mission Diagnostics Hematocrit• Level A and Level B• Used for Hematocrit

Section 9.2.3: Control Fluids 43

External Liquid Quality Controls

FrequencyAs per verification of card shipment:

• With each shipment cards must be analysed in duplicate with 2 levels on any verified reader.

(Take average, compare to Value Assignment Datasheets)

In keeping with any accrediting

bodies, federal, state/territory

guidelines

AACB WP, AACB QC/QA Draft Guidline (April ‘10) 44

External Liquid Quality Controls

Precautions• Follow manufacturer's storage instructions• Allow equilibration (4 hours min)

• For Blood Gas QC• Handle fluid carefully• Once opened analyse immediately • Multiple tests only if using multiple readers

• Hematocrit QC• Not gas sensitive

45Section 9.4: Aqueous Fluid Handling

External Liquid Quality Controls

Procedure

Tests must be run as ‘QA test’QA test results are stored separately from Blood Test Results in epoc Data Manager.

• Shake ampoule - 5 to 10 secs• Hold at tip and at bottom with forefinger and thumb• Tap, if necessary• Snap ampoule off at neck• Immediately transfer into syringe• Transfer into test card

46Section 9.4.6: Procedure

External Liquid Quality Controls

Procedure (con’t)

Recommendations•1mL or 3mL sterile syringe•16-20 gauge blunt (drawing up) needles

•Draw 1mL from bottom of ampoule

•If air bubble present, do not invert syringe

47Section 9.4.7: Procedure

External Liquid Quality Controls

Value Assignment Datasheet

• Contain Target values, ranges.

• Never use values/ranges from pack insert

48Section 9.5: Value Assignment Datasheet

External Liquid Quality Controls

Value Assignment Datasheet

49Section 9.5: Value Assignment Datasheet

Thank you.

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