epoc System Manual Rev 11

Page 1

System

Manual

IVD

Distributed by

Epocal Inc.

Alere North America, LLC

Emergo Europe

2060 Walkley Road

30 S. Keller Road, Suite 100,

Molenstraat 15, 2513 BH

Ottawa, Ontario,

Orlando, FL 32810 USA

The Hague, Netherlands

Canada K1G 3P5

Tel (US): (877) 441-7440

Tel: +31.70.345.8570

Tel: (613) 738-6192

Tel (outside US): (321) 441-7200 Fax: +31.70.346.7299

Fax: (613) 738-6195

Email: service@emergogroup.com

www.epocal.com

© 2015 Alere. All rights reserved. The Alere Logo, Alere, epoc, and Care-Fill are trademarks

of the Alere group of companies. All other trademarks referenced are trademarks of their

respective owners.

51000623 Rev: 12

Page 2

Patents

US D639956; US 6845327; US 6896778; US 7094330; US 7767068; US 7824529; US

7842234; US 8506778; additional patents pending.

51000623 Rev: 12

Page 4

Section

5

6

Title

Page

epoc Reader

5.1 Overview .................................................................................... 5-1

5.2 Power Requirements .................................................................... 5-2

5.3 Rechargeable Battery ................................................................... 5-3

5.4 Reader Status and Firmware Version .............................................. 5-3

5.5 Test Status ................................................................................. 5-4

5.6 Audible Signals ............................................................................ 5-4

5.7 Card Insertion Slot....................................................................... 5-5

5.8 Docking Pivot .............................................................................. 5-5

5.9 USB Maintenance Port .................................................................. 5-6

5.10 Motorized Mechanism ................................................................. 5-6

5.11 Wireless Module ......................................................................... 5-6

5.12 Barcode Scanner ........................................................................ 5-6

5.13 Thermal System ........................................................................ 5-7

5.14 Operating Environment ............................................................... 5-7

epoc Host

6.1 Overview .................................................................................... 6-1

6.2 Rechargeable Battery ................................................................... 6-1

6.3 Barcode Scanner ......................................................................... 6-1

6.4 Soft (Warm) and Hard (Cold) Reset ............................................... 6-2

6.5 Navigation .................................................................................. 6-2

6.6 Entering Text .............................................................................. 6-3

6.7 Date/Time Clock .......................................................................... 6-4

6.8 Status Indicators ......................................................................... 6-4

6.9 User Accounts ............................................................................. 6-5

6.10 epoc Host Application User Interface ............................................ 6-5

6.11 Startup Screen .......................................................................... 6-6

6.12 Login Screen ............................................................................. 6-6

6.13 Operational Modes ..................................................................... 6-7

6.14 Testing Mode ............................................................................. 6-7

6.15 Main Reader Screen ................................................................... 6-8

6.16 Reader Screen ........................................................................... 6-9

6.17 Reader Screen Pages .................................................................. 6-9

6.18 Test Results Page..................................................................... 6-10

6.19 Critical Values Actions .............................................................. 6-12

6.20 Test Information Page .............................................................. 6-13

6.21 Test Selection Page .................................................................. 6-13

6.22 Respiratory Therapy Parameters ................................................ 6-14

6.23 Age and Gender ....................................................................... 6-17

6.24 EDM Synchronization ................................................................ 6-17

6.25 Viewing Tests Mode .................................................................. 6-18

6.26 Viewing Electronic QC Mode ...................................................... 6-20

6.27 Viewing Thermal QA Mode......................................................... 6-21

6.28 Personal Options Page .............................................................. 6-22

51000624 Rev: 23

Table of Contents

Page 2 of 6

Page 5

Section Title

7

epoc Host Administration

Page

7.1 General ...................................................................................... 7-1

7.2 First Time Administrator Login ....................................................... 7-1

7.3 Limitations For Use ...................................................................... 7-1

7.4 Administrator Access .................................................................... 7-2

7.5 Windows Mobile Operating System................................................. 7-2

7.6 Administrator User Interface ......................................................... 7-3

7.7 Administrator Options .................................................................. 7-4

7.8 Barcode Options Page ................................................................ 7-10

7.9 EDM Options Page ..................................................................... 7-11

7.10 Card Options 1 ........................................................................ 7-11

7.11 Card Options 2 ........................................................................ 7-14

7.12 Personal Options Page .............................................................. 7-15

7.13 Software Upgrades ................................................................... 7-15

7.14 Set Date, Time, and Time Zone ................................................. 7-19

7.15 Reader Identifiers .................................................................... 7-19

7.16 Reader Configuration and Reader Software Upgrade ..................... 7-20

7.17 Dedicating Readers .................................................................. 7-21

7.18 Test Record Administration ....................................................... 7-22

8

epoc Enterprise Data Manager

8.1 Introduction ................................................................................ 8-1

8.2 Deployment ................................................................................ 8-1

8.3 Hardware and Software Requirements ............................................ 8-1

8.4 Installation ................................................................................. 8-2

8.5 epoc Database ............................................................................ 8-2

8.6 epoc Link Application.................................................................... 8-2

8.7 Using EDM Web Application ........................................................... 8-3

8.8 Blood Tests Page ......................................................................... 8-4

8.9 Blood Tests: Filtering Results ........................................................ 8-6

8.10 Blood Tests: Printing Results ....................................................... 8-6

8.11 Blood Tests: Exporting List of Tests to CSV File ............................. 8-8

8.12 QA Tests ................................................................................... 8-8

8.13 Reports: Electronic QC ................................................................ 8-9

8.14 Reports: Thermal QA .................................................................. 8-9

8.15 Reports: Usage Statistics .......................................................... 8-10

8.16 Reports: Patients List (ADT) ...................................................... 8-11

8.17 Inventory: Hosts ...................................................................... 8-11

8.18 Inventory: Readers .................................................................. 8-12

8.19 Inventory: Card Lots ................................................................ 8-13

8.20 Inventory: Printers ................................................................... 8-14

8.21 Users Page .............................................................................. 8-14

8.22 Groups Page............................................................................ 8-16

8.23 Host Settings .......................................................................... 8-17

8.24 Host Settings: Units ................................................................. 8-18

8.25 Host Settings: Ranges .............................................................. 8-19

8.26 Host Settings: Software Update ................................................. 8-20

8.27 Departments ........................................................................... 8-21

8.28 Configurations ......................................................................... 8-22

8.29 EDM Settings........................................................................... 8-24

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Table of Contents

Page 3 of 6

Page 6

Section

9

10

11

12

13

Title

Page

Quality Assurance

9.1

9.2

9.3

9.4

9.5

Overview .................................................................................... 9-1

Recommended Quality Control for epoc System ............................... 9-1

Optional Quality Control for epoc System ....................................... 9-3

Aqueous Fluid Handling ................................................................ 9-4

Value Assignment Datasheets ....................................................... 9-6

Care and Maintenance of epoc System

10.1

10.2

10.3

10.4

General Information ................................................................. 10-1

Care of the epoc System ........................................................... 10-1

Cleaning ................................................................................. 10-1

Maintenance ............................................................................ 10-2

Theory of Operation

11.1

11.2

11.3

11.4

11.5

11.6

11.7

epoc Host ............................................................................... 11-1

epoc Reader ............................................................................ 11-2

epoc Test Card ........................................................................ 11-3

Sensor Module ......................................................................... 11-4

Sensor Electrodes .................................................................... 11-6

Quality Control and epoc System ............................................. 11-10

References ............................................................................ 11-14

BGEM Test Card Specifications

12.1 General BGEM Test Card Specifications ..................................... ..12-1

12.2 Test Card Configuration and Use ................................................ 12-2

12.3 pH ......................................................................................... 12-8

12.4 pCO2 .................................................................................... 12-12

12.5 pO2 ...................................................................................... 12-16

12.6 Sodium (Na+) ....................................................................... 12-20

12.7 Potassium (K+) ..................................................................... 12-25

12.8 Ionized Calcium (Ca++) ......................................................... 12-29

12.9 Chloride (Cl-) ........................................................................ 12-34

12.10 Glucose (Glu) ...................................................................... 12-38

12.11 Lactate (Lac) ....................................................................... 12-47

12.11 Creatinine (Crea) ................................................................. 12-52

12.13 Hematocrit (Hct) .................................................................. 12-57

12.14 Calculated Values ................................................................. 12-61

epoc Reader and Host Specifications

13.1

13.2

13.3

13.4

13.5

13.6

13.7

51000624 Rev: 23

epoc

epoc

epoc

epoc

epoc

epoc

epoc

Reader ........................................................................... 13-1

Reader Components ........................................................ 13-2

Host (Socket) ................................................................. 13-3

Host Accessories (for Socket) ............................................ 13-4

Host2 (Motorola) ............................................................... 13-5

System Accessories ......................................................... 13-7

System Compliance ......................................................... 13-7

Table of Contents

Page 4 of 6

Page 7

Section

Title

Page

14

Troubleshooting and Error Messages

15

Glossary

14.1 General ........................................................................ 14-1

14.2 Out-of-Range Results on the Test Card for Liquid Quality

Control or Calibration Verification .................................. 14-1

14.3 Failed Reader Electronic QC ............................................ 14-1

14.4 Failed Thermal QA ......................................................... 14-2

14.5 epoc Host Application Messages ....................................... 14-2

15.1 Symbols ....................................................................... 15-1

15.2 Terminology and Abbreviations ....................................... 15-2

Appendix A.

epoc Host Quick Start Guide (Socket SoMo 650)

Appendix B.

epoc Host2 Quick Start Guide (Motorola MC55A0)

Appendix C.

epoc Reader Quick Start Guide

Appendix D.

epoc Care-Fill™ Capillary Tube Package Insert

51000624 Rev: 23

Table of Contents

Page 5 of 6

Page 8

Document / Revision List

Title

Document

Number

Revision

Cover Page

51000623

12

Table of Contents

51000624

23

01 - Introduction

51000625

08

02 - epoc Blood Analysis System

51000627

06

03 - epoc System Operation

51000635

13

04 - epoc Test Cards

51000629

11

05 - epoc Reader

51000631

08

06 - epoc Host

51000632

14

07 - epoc Host Administration

51000634

15

08 - epoc Enterprise Data Manager

51001364

09

09 - Quality Assurance

51000636

15

10 - Care and Maintenance of the epoc System

51000639

10

11 - Theory of Operation

51000628

10

12 - BGEM Test Card Specifications

51000630

17

13 - epoc Reader and Host Specifications

51000633

11

14 - Troubleshooting and Error Messages

51000638

12

15 - Glossary

51000626

10

Appendix A. epoc Host Quick Start Guide (Socket SoMo 650)

51001684

07

Appendix B. epoc Host2 Quick Start Guide (Motorola MC55A0) 51005527

07

Appendix C. epoc Reader Quick Start Guide

51000848

04

Appendix D. epoc Care-Fill™ Capillary Tube Package Insert

51003903

07

epoc System Manual, Master PDF

51004969

11

51000624 Rev: 23

Table of Contents

Page 6 of 6

Page 9

01

Introduction

1.1 epoc System Manual

General

The epoc System Manual describes the proper use and operation of the epoc Blood Analysis

System. System operators and the system administrator should familiarize themselves with the

applicable sections in the manual prior to conducting testing.

All operators and the system administrator require training by Epocal authorized personnel prior

to conducting patient testing. This training is based upon the information contained in this

manual. The System Manual should be made available to the administrator and operators at all

times while the epoc Blood Analysis System is in use.

Organization of System Manual

The System Manual is organized into sections corresponding with the Table of Contents at the

front of the manual. Each section is controlled and maintained separately by the document and

revision number at the bottom of each page.

Section 2 “epoc Blood Analysis System” provides a brief description of the epoc System and its

major components.

Section 3 “epoc System Operation” describes the steps and necessary information for

performing a test, including sample collection and interpretation of test results.

Sections 4, 5 and 6 “epoc Test Cards”, “epoc Reader” and “epoc Host” describe the function

and construction details of the major system components.

Section 7 “epoc Host Administration” describes to the system administrator how to set up and

maintain key settings in the epoc Host application prior to releasing the system for patient use.

Requirements for ongoing administrative maintenance are also described.

Section 8 “epoc Enterprise Data Manager” describes how to set up and operate the optional

“epoc Data Manager”.

Section 9 “Quality Assurance” describes recommended and additional Quality Control and

Calibration Verification procedures used to verify the performance of the epoc System. These

procedures include internal, liquid, whole blood, calibration verification, and proficiency testing

quality control procedures. The rationale for the epoc System quality control is described in the

“Theory of Operation” section of this manual

Section 10 “Care and Maintenance of the epoc System” section describes the cleaning and

maintenance procedures.

Section 11 “Theory of Operation” contains the methodology, principles of operation and the

special merits and limitations of the epoc System.

Section 12 “BGEM Test Card Specifications” contains performance characteristics and

specifications for the test cards, including measurement ranges, limitations and interferences for

each analyte.

Section 13 “epoc Reader and Host Specifications” provides specifications for the entire system

and each of the major components as well as compliance information.

Section 14 “Troubleshooting and Error Messages” should be referenced if problems arise during

the use of the epoc System.

Section 15 “Glossary” defines terms and acronyms used in the system manual.

51000625 Rev: 08

Introduction

1-1

Page 10

1.2 Cautions

Cautions are identified throughout the manual using the “Caution risk of danger”

or “Caution, consult accompanying documents” symbol. The operator and

administrator need to pay special attention to the instructions accompanying this

symbol to ensure that the epoc Blood Analysis System is used properly, reliably

and safely.

The “Biological risks” symbol is used in the manual to identify potential biological

risks associated with the handling of blood samples. Precautions, as stipulated by

the facility where the epoc System is utilized, must be taken to ensure that the

risk of transmitting blood borne pathogens is minimized.

Other symbols may also be used in the Operator’s Manual. The correct interpretation of

these symbols is located in the Glossary Section.

1.3 Warranty

Epocal Inc. (“Epocal”) warrants to the original customer that the medical equipment

manufactured by Epocal is free from defects in materials and workmanship, and under

normal and proper use conditions, for a period of one (1) full year from the date of

shipment. Upon receiving notice from the customer of any defects within this warranty

period, Epocal shall, at its option and sole discretion, either repair, replace or modify this

medical equipment or part thereof, which proves to be defective. Epocal shall repair or

replace software media and firmware which does not execute as intended due to such

defects. These replacements, repairs, or alterations will in no case extend the specified

herein warranty period. Epocal does not warrant that the operating of the software,

firmware or hardware shall be uninterrupted or error free.

If Epocal is unable, within a reasonable time, to repair, replace or modify any product to a

condition as warranted, the customer shall be entitled to a refund of the purchase price upon

return of the product to Epocal, together with a copy of the dated itemized purchase receipt

and the original packaging.

The test card warranty is limited to, and prorated in accordance with the “use by” date

indicated on the test card labeling. The customer must inform Epocal immediately upon

receipt if it is evident that the test cards were improperly stored or handled during

shipment. Epocal is not responsible for test cards that have been handled and stored outside

the specified requirements stated in the System Manual after delivery to the customer.

The warranty does not cover these parts that deteriorate, or which are in any case

considered consumables, or those parts or items, which by their nature are normally

required to be replaced periodically consistent with normal maintenance .

Note: Warranty rights may vary from state to state, province to province and country to

country.

51000625 Rev: 08

Introduction

1-2

Page 11

1.4 Warranty Limitations

The foregoing warranty shall not apply to defects resulting from:

1

6

7

8

Improper, inadequate, insufficient or negligent storage, care or maintenance by the

customer or an unauthorized person,

Misuse due to carelessness, negligence or inexperience,

Using accessories and/or consumables that are not approved by Epocal,

Unauthorized use of buyer-supplied hardware, software or interfacing,

Unauthorized repairs, modifications, misuse, or damage caused by disposable batteries,

or rechargeable batteries not supplied by Epocal,

Failure to use the device and accessories in accordance with operating instructions,

Operating outside of the environmental specifications of the product,

Improper site preparation or maintenance, or

9

Expiration of test card “use by” date.

2

3

4

5

NO OTHER WARRANTIES, EXPRESS OR IMPLIED, ARE MADE. EPOCAL WILL NOT BE LIABLE

FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING DIRECTLY OR

INDIRECTLY FROM THE FAILURE OF THE PRODUCT TO PERFORM IN ACCORDANCE WITH

SPECIFICATIONS.

Some states do not allow the exclusion or limitation of other express or implied warranties

or incidental or consequential damages, so the above limitations or exclusions may not

apply.

No agent or employee of Epocal is authorized to extend any other warranty or to assume for

Epocal any liability except as set forth above.

1.5 WEEE Compliance

Epocal Inc. complies with Directive 2002/96/EC of the European Parliament and of the

Council of 27 January 2003 on waste electrical and electronic equipment (WEEE).

Compliance is indicated on the epoc hardware using the Wheelie Bin symbol.

Customers should contact their epoc distributer or Epocal Inc., the manufacturer, to arrange

for disposal of their epoc electrical and electronic hardware at the end of product life.

Contact information is provided on the cover page of this instruction manual.

51000625 Rev: 08

Introduction

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Page 12

02

epoc Blood Analysis System

2.1 System Overview

The epoc Blood Analysis System

o

Is a Portable Blood Analyzer comprised

of 3 components:



epoc Reader



epoc Host mobile computer



epoc Test Card

The epoc Reader

o

Is a Battery powered portable device

o

Has an internal barcode scanner

o

Has card slot for accepting test card

o

Reads epoc test cards during blood test

o

Has status indicators to inform user of test progress

o

Measures electrical signals from test card sensors

o

Transmits test results wirelessly via Bluetooth to the

epoc Host

The epoc Host

o

Is a Dedicated use mobile computer with epoc Host software application installed

o

Communicates wirelessly via Bluetooth with epoc Reader

o

Calculates analytical values from sensor data sent by epoc Reader

o

Displays test results

The epoc Test Card

o

Is a single-use device with port for blood sample introduction

o

Contains array of sensors on a Sensor Module

o

Contains calibration fluid within sealed reservoir

o

Generates electrical signals proportional to analyte concentrations in sample

o

Uses Barcode to identify Card Type, “Use By” Date, Serial and Lot Number

51000627 Rev: 06

epoc Blood Analysis System

2-1

Page 13

2.2 Operation Overview

A single blood test is performed in the following way:

1

Use epoc Host to establish wireless connection with an epoc Reader.

2

Obtain a new Test Card and remove from pouch.

3

Insert Test Card into Reader. The Reader reads the barcode on the card. “Use By” date

is checked and card lot number is linked to test result and any related patient data that

was entered.

4

Internal motor of the Reader is actuated to start the calibration process. This process

releases a calibration fluid in the card that flows across sensors within the card. User

has time to prepare the patient and draw the blood sample.

5

User introduces the sample into the Test Card upon completion of calibration.

6

Reader sends test data to the Host. Results are calculated and displayed on the Host in

about half a minute.

51000627 Rev: 06

epoc Blood Analysis System

2-2

Page 14

03

epoc System Operation

3.1 System Operation Overview

Follow set up instructions for the epoc Reader and epoc Host before conducting a

test.

Only use the Test Cards that have been properly stored.

To complete a test, the following steps are required:

1. Turn “ON” the epoc Reader and epoc Host.

2. Log in to epoc Host software application.

3. Discover the epoc Reader by connecting wirelessly from the epoc Host.

4. Begin the test sequence.

5. Insert a new Test Card into the epoc Reader.

6. Enter patient information, select tests and sample type (if applicable).

7. Introduce a blood sample into the Test Card.

8. Observe and possibly print the Test Results.

9. Remove the Test Card and discard it as biohazard waste.

Once logged in and connected to an epoc Reader, steps 5 through 9 above are required to

perform another test.

3.2 Turning “ON” the epoc Reader

Depress the Power Switch to turn “ON” the epoc Reader.

The Power LED will turn green indicating the epoc Reader

is “ON” and ready for use.

epoc Readers that are switched “ON” will be located by

the epoc Host and display on its main screen. Dedicated

Readers display on the screen regardless of whether or

not they are turned on. However, connection will be

successful only if they are ”ON.”

Power

Switch

Turn “OFF” any epoc Readers not in active use to

conserve battery power.

51000635 Rev: 13

epoc System Operation

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Page 15

3.3 Turning “ON” the epoc Host

The Power button of the epoc Host mobile computer starts and stops the device. Press the

Power button to wake up the epoc Host if the screen is blank.

The Soft Reset (Warm Reset) button reboots epoc Host application and displays the Login

page.

Note: Refer to the epoc Host Quick Start Guide to locate these buttons on your Host.

3.4 Logging in to epoc Host Software Application

After a soft (warm) reset or logging out, epoc Host software

application displays the Login Page.

Enter a valid User ID and Password and press the Login

button.

Note: User ID and Password requirements may vary depending

upon how the Administrator has set up the login requirements.

3.5 Running a Test on a Dedicated Reader

If the epoc Host is already configured to connect with a single

dedicated epoc Reader, the epoc Host will automatically

connect to that epoc Reader to run a blood test and begin the

Electronic QC Test.

A connection is cancelled by tapping the Cancel button.

51000635 Rev: 13

epoc System Operation

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3.6 Alternate Means to Run a Test

If the system administrator has configured the system for multiple dedicated epoc Readers,

all epoc Readers available for connection are listed. The Reader Icon displays the Reader

name and the serial number below.

can also be tapped to find (“discover”)

The Discovery icon

more Readers. Tapping the discovery icon when inactive will

initiate this discovery process. Tapping the discovery icon while

discovering will end the discovery process.

Once the desired Reader is displayed, press and hold its Reader Icon

to select it for

testing. A dropdown menu will be displayed. For a blood test, select Run blood test. For a

QA test (if authorized), select Run QA test.

You can also start a blood test by double-tapping the Reader Icon

.

3.7 Reader Electronic Internal QC Test

Connecting to an epoc Reader displays a Reader Screen unique to the epoc Reader’s serial

number. The Reader name is displayed on the bottom tab, with the serial number in

parentheses.

Every time a Host and Reader connect, the Reader begins a two-level Electronic QC Test.

Configuration data is sent by the Host to the Reader, and preparations begin for a test. After

completing the electronic QC test and configuration, the Reader Screen displays Insert

card to begin test, and the Test Status Indicator of the Reader turns and stays green.

8-Hour Electronic QC Check: The epoc Host checks that an Electronic QC Test has been

run within the past 8 hours. If a new Test Card is inserted after the epoc Host has been

connected to the Reader continuously for 8 hours or more, the Host will disconnect from the

Reader and inform the user they must reconnect to the Host to run another Electronic QC

Test.

51000635 Rev: 13

epoc System Operation

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3.8 Reader Screen

The epoc Host and epoc Reader are ready to begin a test by

inserting a Test Card.

The Reader Screen displays:

1. Type of test:

Blood test or

QA test.

2. Battery charge level of the Reader

.

3. Current Date and Time.

4. Patient ID or Lot Number field.

5. Additional tabs

for accessing other test

information entries that may be used to ensure a complete

test record. Requirements may vary according to the policy

of the healthcare institution.

Always verify that current date and time are correct before running a test. The

date and time displayed become part of the test record. Contact the administrator

prior to running a test if adjustment of the date and/or time is required.

The policy of the healthcare institution may require the user to select the

Analytes, Sample Type, and/or Hemodilution Correction Factor for testing.

If running Test Cards on the Use By date identified by the Hourglass Icon

on the bottom of the Test Card, allow sufficient time to complete the test before

midnight. Test results do not display after midnight of the Use By date.

3.9 Obtaining the Test Card

1. Select a properly stored Test Card.

2. Starting at the Notch, tear open the Test Card pouch as shown.

3. Carefully (read the cautions below) remove the Test Card from the

Test Card pouch.

4. Place the Test Card directly into the epoc Reader’s Card Insertion

Slot.

5. Discard the empty pouch.

51000635 Rev: 13

epoc System Operation

Notch

3-4

Page 18

Sensor Module’s contact surface

Never touch the Sensor Module’s

contact surface or Blood Sample

Entry Port.

Never place the Test Card on any

surface before running a test.

Always take the Test Card directly

from the pouch before inserting into

the Reader.

The Test Card pouch should be

opened only when conducting a

blood or QA test to assure a low

humidity environment for the Test

Card.

Blood Sample Entry Port

3.10 Inserting the Test Card

The epoc Reader must be placed on a stable horizontal surface, such as a tabletop,

prior to inserting the Test Card.

Never insert anything except a Test Card into the Reader’s Card Insertion Slot.

This side up

Position the Test Card with the Blue Label

side facing upwards and the Sensor Module

towards the Reader. Test Cards are “keyed”

using a notch in the corner to ensure correct

card orientation during insertion. Insertion of

a Test Card causes the Barcode Reader in the

Reader to turn “ON.”

Insert the Test Card into the Reader’s Card

Insertion Slot at the front of the Reader with

a smooth single motion to enable the

Barcode on the Card Label to be correctly

read by the Reader during insertion.

Continue inserting the Test Card until slight

resistance is felt. Push the Test Card past this point to “lock” it into

place. This is the final Test Card position. Avoid abrupt stops or

unevenness in speed during Test Card insertion.

Upon correct Test Card insertion, the Reader is configured for the card type indicated by the

Test Card Barcode. The Reader performs a series of card integrity checks. The Reader beeps

once, and the Test Status Indicator turns solid green to notify the user that the Test Card

has been successfully inserted.

51000635 Rev: 13

epoc System Operation

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Page 19

Any problem reading the Barcode (or any other error) causes the Test Status Indicator to

turn solid red. Check the Host for an error message and completely remove the Test Card

from the Reader. Reinsert the card for successful insertion confirmed by a solid green Test

Status Indicator.

3.11 Calibration Sequence

Once the Test Card is successfully inserted, a motorized

mechanism in the Reader can be heard as the calibration fluid

is released over the sensors within the Test Card. The Test

Status Indicator on the Reader flashes green to indicate the

start of the test calibration sequence. The Host confirms the

start of the test by entering the calibration mode and displaying

the calibration progress.

The calibration process takes approximately 165

seconds to complete. During this time, the user can

prepare the patient and obtain a blood sample.

The Reader must rest on a flat horizontal surface

without movement for the duration of the test.

3.12 Entering Patient Information (or Lot Number) and Test

Selection

The Patient ID and related information can be entered at any time during the test.

For a Blood Test, the Patient ID number is entered to identify the test results for the Test

Card used for the test.

For a QA Test (not shown), the QA fluid Lot Number is entered instead of the Patient ID.

on the Reader Screen to

Select the Test Information Tab

enter the patient information. The Administrator may require

Sample Type or Hemodilution entries.

Using the arrow , additional settings related to respiratory

therapy, age, and gender may be entered.

Patient information entered prior to completion of the test is

saved automatically with the test results when the test is

complete.

Patient information entered after the test is complete, but

before the next test starts, must be saved by tapping the Save

button.

The Test Information Page for performing QA test contains only the Comments field (not

shown).

If the Patient ID is not entered prior to completion of the test, the user is prompted to enter

the Patient ID when the test results are displayed.

51000635 Rev: 13

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Exercise care when entering Patient ID and other information. Ensure the correct

Reader is selected by verifying that the Reader name corresponds with the Reader

used to conduct the test.

on the Reader Screen to

Select the Test Selection Tab

select or deselect analytes to display in the test results. The

system administrator settings may require analyte selection

before results are displayed. Additional analytes may be selected

after test completion. Once test results are displayed, analytes

can no longer be de-selected.

3.13 Using Barcode Scanner to Enter Patient ID

Press the stylus in the Patient ID field. A cursor appears.

Activate the Barcode Scanner by pressing any of the Scan buttons on the epoc Host. The

Barcode Icon at the top of the screen indicates when the barcode scanner is ready to scan.

Point the light coming from the top of the Barcode Scanner towards the desired barcode

until a beep is heard. The scanner turns off. The scanned text appears in the field where the

cursor was left.

Warning: Never look directly at the laser light. Point the laser only at a barcode

and away from the eyes at all times.

The Patient ID may also be entered using the stylus and the Onscreen Keyboard

accessible from bottom of screen via the Text Input button.

3.14 Collecting a Blood Sample

Read information on Sample Collection in the BGEM Test Card Specifications section

of this Manual to ensure that blood samples are properly collected and handled for

testing.

3.15 Timing of Sample Introduction

After about 165 seconds of calibration the Test Status Indicator

stops flashing green indicating that the Test Card is ready to

receive a test sample.

The epoc Host displays the message, “Inject sample….”

The screen has a bar indicating the time remaining to introduce

a sample. The blood sample must be introduced into the Test

Card during this 450-second (or 7.5-minute) period.

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Introducing the sample too soon or too late will cause an error and abort the test.

A new Test Card must be inserted and the test procedure started again.

3.16 Sample Introduction

1. Hold the syringe barrel vertically between finger tips

and thumb (as shown in Figure 1).

Keep Syringe vertical and perpendicular to the Test

Card to avoid sample spillage.

Complete steps 2 and 3 below in one continuous motion to

ensure best performance of sample introduction.

2. Using slight downward pressure, secure the

syringe’s luer tip into the center recess of the blood

sample entry port of the Test Card. Rotate the

syringe up to 1/4 turn to ensure a good seal (as

shown in Figure 2).

Figure 1

The User should feel the syringe tip engage with the rubber

seal of Test Card entry port. Press the syringe with enough

downward force to engage the syringe tip with the blue rubber

seal.

3. While maintaining downward pressure, use index

finger of the other hand to steadily depress the

syringe plunger with a single, smooth, continuous

motion until prompted to stop (as shown in Figure

3).

The Reader provides an audible beep and the Test Status

Indicator flashes green indicating enough sample for analysis

was received. The Host also displays sample acceptance.

Figure 2

Learn to use the audio and visual feedback to perform this

step easily and reliably. A normal dispense operation takes

about 1 second or less.

Sample introduction should never exceed 2

seconds. Failure to heed the audio or visual prompts

may cause the sample to flow from the vent hole at

end of the Test Card waste chamber and possibly

into the epoc Reader.

Never attempt to clean inside the Reader.

Figure 3

Avoid rapid sample introduction because it can cause fluid segmentation. This

condition is detected by the system. The test is aborted, and the Host displays an

error message.

The Reader automatically analyzes the test sample. The analysis process takes about half a

minute.

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3.17 Test Completion

Once the analysis is complete, the epoc Host displays the Test Results from the Reader

Screen (tab

on the left).

The Patient ID must be entered before the test results are

displayed. Once saved, the Patient ID textbox and Save button

are disabled again.

When the Reader has completed a test, the Test Status Indicator

on the Reader will flash green, indicating the Test Card can be

removed. The motorized mechanism is heard briefly as the

calibration fluid plungers are disengaged.

Remove the card from the Reader and dispose of it using

appropriate biohazard precautions.

Always wear protective gloves when removing a Test Card from the Reader.

Never reuse a Test Card. Test Cards are for single use only.

3.18 Running Another Test

After removing the used Test Card, the Reader’s Test Status Indicator will turn solid green,

indicating that the Reader is ready to perform another test.

Repeat the same procedure to complete another test.

Starting a new test permanently saves the previous test record. Changes to that

test are no longer possible.

If the system is configured to allow data recall on incomplete

tests, the question Recall data from previous test? may

appear in place of the Patient ID entry. The user can select

Yes or No to proceed. If neither option is selected before the

test ends, the previous test data will not be recalled.

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3.19 Closing the Test and Disconnecting the Reader

When all testing with the Reader is complete and all data entries are made, the test is

closed by tapping on the Red X

at the top right to close the Reader Screen for that

Reader. Disconnecting a Reader does not affect the connection or test status of other

Readers already discovered or connected.

Closing the test and disconnecting the Reader permanently saves the test and

changes to that test are no longer possible.

3.20 EDM Synchronization

For epoc Enterprise Data Manager (EDM) users only:

After disconnecting all Readers from running tests, test results

can be sent to the EDM by pressing the EDM synchronization

button

on the Host. The epoc Host also retrieves

configuration information such as operator lists by using this

feature. Synchronizing with the EDM may also be accessed

from the Tools menu, lower left corner.

The Administrator may configure the epoc Host to synchronize

upon closing a test.

In this configuration, the EDM

synchronization procedure occurs immediately after the Reader

Screen is closed at the end of a test.

3.21 Logging Out and Turning the Power “OFF”

Log out of the epoc Host Application when finished testing and

viewing test results. Select “Tools,” then “Logout” on the

menu at the bottom left corner of the screen, or press the

. Use the Power button on the Host to

Logout button

turn the device ”OFF.”

Note: Upon epoc Host logout, users will be notified of expiring

user account privileges. Notifications to users begin at 30

days before the expiration date.

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The Reader automatically powers “OFF” after 20 minutes of idle time to conserve battery

power, but only if:

a) The Reader is NOT plugged in

AND

b) The Reader is NOT connected to a Host.

3.22 Multiple Reader Testing

The epoc System allows multiple Readers to connect to a single Host and run multiple tests

simultaneously. The Host displays a unique Reader Screen for each Reader connected to a

Host. Up to seven (7) Readers can be connected to a Host at the same time. Up to four (4)

of these Readers can perform tests concurrently.

Discover all required Readers using the Host before running multiple tests. Discovery is not

permitted while the Host is connected to one or more Readers. Disconnect all connected

Readers before attempting to discover additional Readers.

Once discovered, a Reader can be connected to the Host at any time. Connect to each

Reader at any time before starting a test on each Reader. Run tests for each Reader using

the same instructions for running a test as when using a single Reader.

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04

epoc Test Cards

4.1 General Test Card Information

A Test Card is comprised of an array of sensors on a sensor module mounted in a creditcard sized fluidic housing with a sample entry port, and a sealed calibrator fluid reservoir.

Measurement region

Sensor module:

contact surface

Sensor module:

sensor surface

Test panel type

Valve

Blood waste chamber

Sealed calibrator

reservoir

Barcode

Sample entry port

Test Card – TOP

Test Card – BOTTOM

Refer to BGEM Test Card Specifications Section of this Manual for more information.

4.2 Test Card Physical Characteristics

Size

L86 mm × W54mm × H1.4mm

Weight

6.3 ± 0.3 grams

Materials

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Co-polyester body;

Polypropylene adhesive labels;

Polyethylene-coated aluminum foil;

Water-based calibration fluid;

Fiberglass-reinforced epoxy tape with an array of nickel-gold-coated copper

electrodes.

epoc Test Cards

4-1