epoc System Manual Rev 11

Patents US D639956; US 6845327; US 6896778; US 7094330; US 7767068; US 7824529; US 7842234; US 8506778; additional patents pending.

51000623 Rev: 12

Table of Contents Section 1

2 3

4

Title

Page

Introduction

1.1 epoc System Manual ... 1-1 1.2 Cautions ... 1-2 1.3 Warranty ... 1-2 1.4 Warranty Limitations ... 1-3 1.5 WEEE Compliance ... 1-3

epoc Blood Analysis System

2.1 System Overview... 2-1 2.2 Operation Overview ... 2-2

epoc System Operation

3.1 System Operation Overview ... 3-1 3.2 Turning ”ON” the epoc Reader ... 3-1 3.3 Turning ”ON” the epoc Host ... 3-2 3.4 Logging in to epoc Host Software Application ... 3-2 3.5 Running a Test on a Dedicated Reader ... 3-2 3.6 Alternate Means to Run a Test ... 3-3 3.7 Reader Electronic Internal QC Test ... 3-3 3.8 Reader Screen ... 3-4 3.9 Obtaining the Test Card ... 3-4 3.10 Inserting the Test Card ... 3-5 3.11 Calibration Sequence ... 3-6 3.12 Entering Patient Information (or Lot Number) and Test Selection ... 3-6 3.13 Using Barcode Scanner to Enter Patient ID ... 3-7 3.14 Collecting a Blood Sample ... 3-7 3.15 Timing of Sample Introduction ... 3-7 3.16 Sample Introduction ... 3-8 3.17 Test Completion... 3-9 3.18 Running Another Test ... 3-9 3.19 Closing the Test and Disconnecting the Reader ... 3-10 3.20 EDM Synchronization ... 3-10 3.21 Logging Out and Turning the Power ”OFF” ... 3-10 3.22 Multiple Reader Testing ... 3-11

epoc Test Cards

4.1 General Test Card Information ... 4-1 4.2 Test Card Physical Characteristics ... 4-1 4.3 Test Card Packaging, Storage, and Shelf Life... 4-2

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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

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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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Section 9

10

11

12

13

Title

Page

Quality Assurance

9.1 Overview ... 9-1 9.2 Recommended Quality Control for epoc System ... 9-1 9.3 Optional Quality Control for epoc System ... 9-3 9.4 Aqueous Fluid Handling ... 9-4 9.5 Value Assignment Datasheets ... 9-6

Care and Maintenance of epoc System

10.1 General Information ... 10-1 10.2 Care of the epoc System ... 10-1 10.3 Cleaning ... 10-1 10.4 Maintenance ... 10-2

Theory of Operation

11.1 epoc Host ... 11-1 11.2 epoc Reader ... 11-2 11.3 epoc Test Card ... 11-3 11.4 Sensor Module ... 11-4 11.5 Sensor Electrodes ... 11-6 11.6 Quality Control and epoc System ... 11-10 11.7 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 epoc Reader ... 13-1 13.2 epoc Reader Components ... 13-2 13.3 epoc Host (Socket) ... 13-3 13.4 epoc Host Accessories (for Socket) ... 13-4 13.5 epoc Host2 (Motorola) ... 13-5 13.6 epoc System Accessories ... 13-7 13.7 epoc System Compliance ... 13-7

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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

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Document / Revision List Title

Document Number

Revision

Cover Page

51000623

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Table of Contents

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01 - Introduction

51000625

08

02 - epoc Blood Analysis System

51000627

06

03 - epoc System Operation

51000635

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04 - epoc Test Cards

51000629

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05 - epoc Reader

51000631

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06 - epoc Host

51000632

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07 - epoc Host Administration

51000634

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08 - epoc Enterprise Data Manager

51001364

09

09 - Quality Assurance

51000636

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10 - Care and Maintenance of the epoc System

51000639

10

11 - Theory of Operation

51000628

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12 - BGEM Test Card Specifications

51000630

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13 - epoc Reader and Host Specifications

51000633

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14 - Troubleshooting and Error Messages

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15 - Glossary

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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

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

51003903

07

epoc System Manual, Master PDF

51004969

11

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Table of Contents

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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.

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Introduction

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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.

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Introduction

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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.

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Introduction

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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

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epoc Blood Analysis System

2-1

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.

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epoc Blood Analysis System

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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.

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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.

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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.

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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.

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Notch

3-4

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

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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. 51000635 Rev: 13

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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. 51000635 Rev: 13

epoc System Operation

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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.

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4.3 Test Card Packaging, Storage, and Shelf Life 4.3.1 Packaging Each single use Test Card is packaged by the manufacturer into a card pouch, which also contains one (1) strip of desiccant. Fifty (50) card pouches are packed into boxes of 50 cards. Quantities of 50 Card Boxes are packed into larger shipping cartons.

4.3.2 Shipping Controls Note: epoc Test Cards are shipped by the distributors using validated shipping containers. Only approved shipping and handling procedures must be followed. Test Card shipping cartons include two (2) Temperature Monitors, which change color when the shipping temperature is outside the specified range. A Low Temperature Monitor turns red below 2° C. A High Temperature Monitor turns red above 30°C. Temperature monitors must be checked when Test Cards are received to verify that the temperature limits were not exceeded during shipment. If one or both of the temperature monitors indicate any RED, place the card shipment on “Hold” and isolate from possible use. Contact Technical Services. High Temperature Monitor

Low Temperature Monitor

FAIL: Cards Stored above 30°C

FAIL: Cards Stored below 2°C

PASS: All 3 windows are white

PASS: Window is white

Temperature Monitors

Shipping Carton Box of 50 Test Cards

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Never use Test Cards shipped outside the specified temperature limits (2°-30°C). Never subject Test Cards to excessive shock (dropping, throwing, shaking) during shipping and handling. Note: epoc Test Cards should be stored at room temperature (15°-30° C), but they may be transported by the distributors at lower temperatures (2°-30°C), provided transportation times do not exceed eight (8) days.

4.3.3 Card Pouch

Card Pouch

The card pouch contains one (1) Test Card and one (1) strip of desiccant. A tear notch is used to tear open the pouch.

Tear Notch

Test Card Desiccant Strip

4.3.4 Test Card Storage Always store Test Cards at room temperature (15°-30°C). The shipping boxes are not to be used for storage. It is the responsibility of the customer facility to constantly maintain the temperature above 15° and below 30°C. The temperature monitors are for shipping use only. The card pouches provide a low humidity environment for card storage. The card pouch should be opened and the Test Card removed only when conducting blood or QA testing. Never store Test Cards outside of the card pouch or near intense light or heat sources. Never subject Test Cards to excessive shock (dropping, throwing, shaking) during storage. 51000629 Rev: 11

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4.3.5 Removing Cards from the Card Pouch Never use a Test Card if the card pouch seal has been compromised in any way. The low humidity threshold within the pouch may have been exceeded. For a blood or QA test, a Test Card must be taken directly from the card pouch. Never place a Test Card on any surface prior to use.

4.3.6 Test Card Use Cards brought from a warmer or colder storage environment (even within the same building) must be allowed to adjust to the same temperature as the testing room ambient temperature before use. The testing environment, epoc Reader, and epoc Test Cards must all be at the same temperature before conducting any testing. Strong mechanical shocks to the card container may induce bubbles in the Test Cards. Never drop or otherwise mechanically stress the Test Cards or pouches.

4.3.7 Test Card Shelf Life All epoc Test Cards have a limited shelf life. Test cards must be used before the end of the Use By date printed on each Test Card. Shelf life is affected if Test Cards are stored outside specified storage temperature limits. The Use By date is encoded into the Barcode on each Test Card. The epoc Reader will reject any Test Card past the Use By date on the Test Card. The Use By date is based upon continuous storage of the Test Cards between 15° and 30°C.

“Use by” date

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05

epoc Reader

5.1 Overview The epoc Reader is a simple-to-use raw-signal acquisition peripheral. The Reader and Host mobile computer together comprise all of the subsystems generally found in a traditional blood analyzer that operates on single use sensors and reagents. The Reader has a card slot for accepting a Test Card, and an Electro-Mechanical Actuation Assembly for engaging the Test Card after it is inserted into the Card Slot. When the internal Motor Drive is activated, a Push Pin in the Reader breaks the Valve in the Test Card and drives Plungers causing the Calibration Fluid to flow across the Sensor Module. The Reader includes circuits for amplifying, digitizing and converting the raw sensor signals to a wireless transmittable Bluetooth format. At the rear of the Reader is a Docking Pivot with a slot for the epoc Host. The Docking Pivot provides a charging connection for the Host battery. The epoc Reader has no user serviceable parts, with the exception for the lithium battery and battery door. Never disassemble the Reader or place any foreign objects into the Card Insertion Slot or the Docking Pivot.

Indicators:

Membrane Switch Layout

Docking Pivot

epoc Reader – Front View

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Maintenance Port (covered)

epoc Reader AC Adaptor

epoc Reader – Rear View Power Jack

5.2 Power Requirements The Reader operates on a rechargeable battery inside the Reader. The Reader can be operated on battery power only or while the battery is being charged using the AC Adapter provided with the Reader. The AC Adapter plugs into the Power Jack located at the rear of the Reader. Use only the AC Adapter, as specified in “epoc Reader and Host Specifications” section of the epoc System Manual. Exercise caution if using an Extension Cord or Power Bar for use with the Reader AC Adaptor. These devices may void the product safety certification if not appropriately certified or approved for medical use. Never remove the AC Adapter from an electrical outlet by pulling the cord or by pulling it out at an angle. Otherwise, the plug may break and potentially be left in the electrical outlet. Should the plug ever break in the electrical outlet, remove the broken plug from the wall while wearing electrical safety gloves. This adds extra protection to the user from electric shock.

The Power Button is located on the Membrane Switch. Press the button to power up the Reader. The Power Indicator turns solid green indicating that the Reader is “ON.” Press and hold the Power Button for several seconds to turn ‘OFF’ the Reader when not in use to conserve battery power. The AC Adapter recharges the Reader when the Reader is either “ON” or “OFF.”

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5.3 Rechargeable Battery The epoc Reader contains a Lithium Ion Rechargeable Battery. The battery and the door to the battery compartment may be replaced by the user. Please refer to the Care and Maintenance of the epoc System section of the epoc System Manual for instructions on replacing the battery and the battery door. Fully charged, the Reader can process about fifty (50) Test Cards before recharging. If the Reader is left ‘ON’ for prolonged periods of time between tests, this amount will be reduced.

When the Reader is charging, the amber battery status indicator will flash. When charging is complete, this indicator will stay solid amber. When the indicator is off, it indicates that the AC Adaptor is not connected and the Reader is operating on battery power. It requires approximately four (4) hours to recharge a fully discharged Reader Battery.

5.4 Reader Status and Firmware Version Use the epoc Host to obtain the Reader status. Use “Tools”  “Status” when connected to the Reader or press on a Reader icon from the Main Reader Screen and tap “Status” on menu that appears. The epoc Reader Status is displayed. The third tab

provides the Reader firmware version.

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5.5 Test Status The Test Status Indicator informs the user of the test status. When the indicator is “OFF” the Reader is not connected to a Host. When a Host first connects to a Reader, the indicator will turn solid green to inform the user that the Reader is ready for use. When the indicator begins to flash green, it indicates that the Reader is busy processing and the user should wait. When the Indicator turns solid red, it notifies the user of an error condition. The required user action is determined from the context of the test.

Solid Green when:

Required User Action

Test card is first inserted

Fully insert card

Calibration is complete

Inject sample

Test is complete. Results are available

Remove card

Reader is being paged (slow flash with beeps)

No action required

Solid Red when: Error has occurred

Check the Host for further action

5.6 Audible Signals The epoc Reader uses a “beeping” sound to provide user feedback. Audible Signal Normal Beep

Interpretation Test Card is first inserted and Card Barcode is successfully read. Adequate sample has been introduced into Test Card OR Sample introduction window has timed out

Quick Beeps

Calibration is complete and test sample may be introduced

Long Beeps

Reader is paged from a Host

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5.7 Card Insertion Slot The epoc Reader has a Card Slot for inserting the Test Card. Within the Card Slot there is a Card Entry Switch, a Barcode Scanner, an Electrical Contact for contacting the Test Card Sensor Module upon insertion, and a Thermal Subsystem for heating the card’s measurement region to 37oC during the test. The Test Card has a Notch, allowing only a correctly orientated Test Card insertion into the Card Slot. A properly orientated card requires minimal force for insertion and encounters minimal resistance up to full insertion.

Card Insertion Slot

Notch in Test Card

Never force a Test Card into the Card Slot. If correctly orientated, the Test Card should enter easily with minimal effort. Never insert any object other than a Test Card into the Card Slot. Never use a Test Card that may be contaminated (wet or with foreign material attached). Avoid placing the Test Card on any surface prior to test. Insert Test Card directly from the Test Card Pouch and insert into the Card Slot.

5.8 Docking Pivot The Docking Pivot provides a physical link between the epoc Reader and epoc Host. A pocket in the Docking Pivot accepts the blade section of the Host Cradle. When docked in the open position, the Host sits with its Screen at 15 degrees from vertical. When in the closed position, the Host is rotated flat against the top surface of the Reader, an internal spring latch provides a holding force, and an edge of the Cradle fits into a pocket in the Reader cover preventing removal of the Host. An Internal Spring contact in the Docking Pivot makes an electrical connection to the Host via Contact Strips on the surface of the Cradle Blade. When docked to a Reader connected to the AC Adapter, the Host Battery is recharged through this connection.

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