Fio V200 User Manual

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G01-LBL-01

R01

deki Reader v200 User Manual Release

Document - Released

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10 Oct 2017

DCO-MC-04OCT2017-001

DOCUMENT NUMBER:

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Signature Manifest

Document Number: G01-LBL-01 Revision: R01 Title: deki Reader v200 User Manual

All dates and times are in Eastern Standard Time.

Approval of V200 User Manual

Document Approval

Name/Signature Title Date Meaning/Reason

Roman Zastawny (RZ) VP, Diagnostics 05 Oct 2017, 11:11:09 AM Approved

Ian Fine (IF) Chief Technology Officer 10 Oct 2017, 03:09:06 PM Approved

QA Approval

Name/Signature Title Date Meaning/Reason

Bob Ray (BR) VP, RA & QA 05 Oct 2017, 11:39:32 AM Approved

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Deki™ Reader v200

User Manual

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Emergo Europe Prissessegracht 20 2541 AP The Hague The Netherlands

Fio Corporation 111 Queen Street East, Suite 500, Toronto, Ontario, M5C 1S2 Canada Office: 1.416.368.8882 | Email: [email protected]

Fio.com

Local Contact for Support:

© 2017 Fio Corporation. All rights reserved. Fio is a registered trademark. Deki and Fionet are trademarks of Fio Corporation. Android and Google are trademarks of Google Inc. Adobe and Acrobat are trademarks of Adobe Systems Inc.

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Contents

General Information ............................................................................. 1

Warning and precautions ...................................................................... 1

Environmental Precautions.................................................................... 1

Labels and Symbols ............................................................................... 2

Training requirements ........................................................................... 3

Introduction ......................................................................................... 4

Product description ............................................................................... 4

Intended Use......................................................................................... 4

Unpacking and Setup............................................................................. 4

Deki Reader and Accompanying Components ........................................ 4

Transporting the Deki Reader ................................................................ 5

Device at a Glance ................................................................................ 5

Deki Reader - Front View ....................................................................... 5

Deki Reader - Back View ........................................................................ 6

Operating the Deki Reader.................................................................... 6

Deki Reader setup ................................................................................. 6

Powering and charging the Deki Reader................................................. 7

Power and status indicators................................................................... 7

Powering on the Deki reader ................................................................. 8

Waking up the touchscreen ................................................................... 9

Hardware status icons ........................................................................... 9

Using the touchscreen..........................................................................10

Using the on-screen keyboard ..............................................................10

Logging in.............................................................................................11

Updating the date and time settings .....................................................11

Fio Launcher Screen .............................................................................13

Action Bar ............................................................................................13

Locking the Deki Reader during use ......................................................13

Logging out after use............................................................................13

Powering off the Deki Reader ...............................................................13

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Test Drawer .........................................................................................14

Using Rapid Diagnostic Tests with the Deki Reader ............................. 15

About the Analyzer Application.............................................................15

Managing Tests on the Worklist............................................................15

Adding Tests to the Worklist.................................................................16

Interpreting and Documenting Tests .....................................................18

Errors and Device Failures ....................................................................21

Error and Warnings............................................................................. 21

Errors...................................................................................................21

Warnings .............................................................................................21

Maintenance and Cleaning.................................................................. 22

Maintenance........................................................................................22

Cleaning...............................................................................................22

Cleaning the Deki Reader control strip .................................................22

Software Updates ............................................................................... 23

Appendices......................................................................................... 24

Appendix A: Analytical performance characteristics..............................24

Appendix B: Technical Specifications....................................................25

Appendix C: Operating, Storage and Handling Conditions .....................25

Appendix D: Recycling and disposal......................................................26

Appendix E: Notices.............................................................................26

Appendix E: Accessories .......................................................................27

Index .................................................................................................. 28

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General Information

Warnings and precautions

Failure to observe warnings and precautions listed in this manual may result in false test results, personal injury and/or damage to the Deki Reader.

Warnings

 Do not disassemble the Deki Reader.  Unplug the Deki Reader before cleaning.  Do not immerse the Deki Reader in water or cleaning solutions.

Biohazard precautions

 Use universal precautions and personal protective equipment when

using the Deki Reader and/or handling potentially biohazardous materials.

 Regularly maintain, clean, and decontaminate the Deki Reader (see

Maintenance and Cleaning section for more information)

Cautions

 For in vitro diagnostic use.  Use the Deki Reader for diagnostic purposes only if you are qualified

to do so.

 Do not move the Deki Reader while an RDT is in the drawer. Use only

the power supply that is provided with the instrument. Use the appropriate power supply for the region. The correct power supply is required to maintain the safety and electromagnetic compatibility of the system.

 Do not use the Deki Reader outside of allowable operating conditions

(see Appendix C for more information)

 The accuracy of the Deki Reader’s interpretation of RDT results

depends on the quality of the RDT used. It is the responsibility of the user to process the RDT according to the manufacturer’s instructions.

 The Deki Reader is a support tool that, in conjunction with the RDT,

provides information to aid in diagnosis; it is not intended to determine or recommend a course of action or treatment.



Environmental Precautions

 To protect the environment, the Deki Reader and lithium ion

batteries should be disposed of according to loc al regulations and procedures (see Appendix D for more information)

 Decontaminate the Deki Reader as per the cleaning and maintenance

instructions in this user manual prior to return or disposal (see Maintenance and Cleaning section for more information)

 The Deki Reader is being used outside of the control of the

manufacturer and distributor; therefore, results may be affected by environmental factors and/or user error.

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Labels and Symbols

The following symbols represent warnings, precautions, standards and compliances associated with use of the Deki Reader. These symbols may appear in this user manual, or the Deki Reader or any of its accompanying components.

SYMBOL EXPLANATION SYMBOL EXPLANATION

Caution: If not followed could result in injury to the operator

Consult the instructions for use

In vitro

diagnostic medical device Authorized representative in the European Community

Temperature limitation

Humidity limitation

Complies with Part 15 of the Federal Communications Commission (FCC) Rules

Date of Manufacture

ETL Symbol to be

inserted

Biohazard

Caution: If not followed could lead to erroneous results or damage to the device

CE Mark

Manufacturer

Serial number

Electrical safety tested and certified against international standards

Complies with the Waste Electrical and Electronic Equipment directive

Do not use if package is damaged

Positive Polarity Direct current

USB Ethernet

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Training requirements

Read this entire user manual before using the Deki Reader. Practice with the Deki Reader before using its results for diagnostic purposes. Failure to comply with these training requirements may lead to inaccurate results. Contact Support if you require additional Deki Reader training.

 Users are expected to be proficient in the use of RDTs

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Introduction

Product description

The Deki Reader is a battery -powered, camera-based instrument that aids in the interpretation of rapid diagnostic tests (RDTs). It can be used in laboratory and non -

laboratory settings (i.e. point of care settings). The Deki Reader’s Analyzer application

helps manage and document patient or samples IDs and allows the user to process a RDT in various modes including a step-by-step guidance mode. Following the insertion of a rapid test in the Deki Reader drawer a digital image of the RDT is captured. Image analysis algorithms are used to perform RDT identification followed by detection and analysis of control and test line are analyzed according to the validated configuration for the identified RDT. The reader also has the ability to detect certain RDT processing errors. In the end, the reader displays the results (positive, negative, invalid or error detected) on the display screen and stores the results in instrument memory. In addition, the results can be uploaded to the Fionet™ data management system. Once the results are uploaded they are no longer available on the reader. The Deki Reader operates using the Android™ platform and can host other non-medical apps.

Intended Use

The Deki Reader is an in vitro diagnostic device that captures, interprets, and transmits results from validated rapid diagnostic tests.

The Deki Reader is intended to be used as an aid to the interpretation of rapid tests that have been validated for use with the instrument. The Deki Reader is suitable for use in laboratory and non-laboratory (i.e. point of care) settings.

The Deki Reader is for professional use only.

The Deki Reader is intended to be used in accordance with the indications and instructions for use of its compatible rapid tests. Refer to each specific package insert

for details on running the individual tests.

Unpacking and Setup

Unpack the Deki Reader and its accompanying components on a clean, flat, level and stable surface. Ensure that all accompanying components have been provided with the Deki Reader (see list below) or contact Support if any items are missing or damaged. Visually inspect the outer packaging, the Deki Reader, and its accompanying components, and immediately report any obvious signs of damage to Support. Store the Deki Reader’s packaging for later use.

Deki Reader and Accompanying Components

Check to make sure that the following components are included in the packaging:

 Deki Reader  Deki Reader rechargeable battery  USB power adapter with international plugs  6 ft. (1.8m) cable  Deki Reader User Manual  Deki Reader Quick Start Guide

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Transporting the Deki Reader

The Deki Reader and its accompanying components may be carried in a specially designed travel bag (optional accessory). If the Deki Reader must be shipped, packag e the Deki Reader in its original packaging or contact Support for proper packaging.

Device at a Glance

Deki Reader - Front View

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Deki Reader - Back View

Operating the Deki Reader

Deki Reader setup

Locate the Battery access panel at the underside of the Deki Reader.

Move the slider to the “unlock “position and lift the panel to access the battery compartment Insert the battery provided in the Deki Reader packaging into the slot ensuring that the battery contacts line up with the pins in the battery compartment.

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Once the battery has been inserted into the device, close the access panel and move the slider to the “locked” position. Follow the steps below to charge the Deki Reader.

 Do not force the battery into the access panel as it is designed to be

inserted in one orientation only.

Powering and charging the Deki Reader

Open the cover at the back of the Deki reader to access device ports

To charge the Deki Reader connect the AC/DC adapter provided to the Power (DC) port at the back of the reader. Plug the other end into a power outlet.

 Do not move the Deki Reader while an RDT is in the drawer. Use only

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Power and status indicators

Status Indicator LED Colour Device Status

Device is not connected to a power source Device is plugged into a power source and the battery is fully charged

Device is power on, battery is charged

Device is power on, battery needs charging

Device is in standby mode, battery needs to be charged

External Power Indicator

Status Indicator

Off

Green (solid)

Off Device is powered off

Green (solid)

Green (flashing*) Device is in standby mode

Red (solid)

Red (flashing*)

Powering on the Deki reader

To power on the Deki Reader push the power button ( ) until you see the power indicator on the top of the device illuminate. If the device is connected to the AC/DC adapter the power indicator will already be illuminated, in this case push the power button ( ) until the Fio logo appears on-screen.

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Waking up the touchscreen

After a period of inactivity, the touchscreen will turn off automatically to preserve the Deki Reader’s battery life. To wake up the touchscreen, push the power button ( ) until you feel a “click” and immediately release it.

If you have trouble activating the Deki Reader:

1. Make sure the Deki Reader battery is charged; power & charging indicator is green.

2. If the charging indicator is red or is not illuminated, follow the instructions in the “Powering and charging the Deki reader” section of this document.

Hardware status icons

The status bar at the top of the screen provides information about cellular and wireless signal strength, battery charge level and time.

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Using the touchscreen

User your fingertip or a stylus to interact with items on the touchscreen in the following ways:

Gesture How it works What it does

Tap

Firmly and briefly tap on an item with your fingertip or stylus

Selects or activates on- screen items

Slide to scroll

Firmly and quickly drag your fingertip or stylus across the surface of the screen without pausing

Scrolls through on-screen items (for example, slide up or down across the screen to scroll through a list)

Using the on-screen keyboard

Use the on-screen keyboard to enter text whenever prompted:

At any time, press the hardware key to close the on-screen keyboard.

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Logging in

Enter login credentials using the on-screen keyboard by touching the relevant text box. Touch this icon to temporarily make the text in the password field visible.

Once the appropriate credentials are entered, touch this icon to complete the login process.

Updating the date and time settings

After logging in, you may be prompted to update the date and time settings before taking any other action – follow the instructions below to carry out this procedure. If the date and time settings are correct, you will be taken directly to the home screen (see next section).

Touch the green checkmark to continue onto the Android settings page

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Set date:

Set time:

Touch “Set date” and scroll through fields to set the current date. Touch “Done” to continue

Touch “Set time” and scroll through fields to set the current time. Touch “Done” to continue

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Set time zone:

Touch “Select time zone”. Scroll to the correct time zone in the list and touch the field to continue

Once the correct date, time and time zone have been set, touch the hardware key to go back to the home screen.

Fio Launcher Screen

To be completed

Action Bar

To be completed

Locking the Deki Reader during use

To be completed

Logging out after use

To be completed

Powering off the Deki Reader

Before switching the device off, ensure that there are no open worklists. To power off the Deki Reader push the power button ( ) for 2 – 3 seconds until you see the Power off menu appear on screen:

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Open

Touch the “Power Off” item to switch the device off.

Test Drawer

When promoted by the Deki Reader Analyzer application, you will need to place a rapid diagnostic test (RDT) in the Deki Reader’s test drawer for image capture and analysis. Follow on-screen messages when prompted for instructions on when to insert and remove RDTs.

Open:

To open the test drawer, press and release on the symbol located on the right side of the Deki Reader. If the drawer does not open completely, grasp the edge of the drawer and gently pull it out.

Close:

To close the test drawer, press the symbol firmly until the drawer is fully closed. Once you release pressure, the drawer will adjust outward slightly as the latch engages.

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Using Rapid Diagnostic Tests with the Deki Reader

About the Analyzer Application

The Deki Reader’s Analyzer application may be used to aid with the interpretation and documentati on of rapid diagnostic tests. This application can be launched in one of two ways:

 Directly, by tapping on the Deki Reader icon on

the Fio Launcher screen (shown right)

 Indirectly, via another application on the device Launching the application directly from the Fio Launcher screen will open the home screen of the Deki Reader’s Analyzer application (shown below). From here you can:

 Tap the Settings icon in the top left corner to

review or change the settings of the Deki Reader’s Analyzer application.

 Manage tests in progress on the device’s

Worklist.

 Tap the Add button in the bottom right corner to add a new test to the

device’s worklist.

Managing Tests on the Worklist

The Worklist within the Deki Reader’s Analyzer application may be used to manage multiple tests simultaneously. A Red or Yellow Countdown Timer is displayed beside a test when using the device timer to wait for its results. The timer starts off yellow and then turns red when it is almost done counting down . Tests with less time remaining appear higher on the worklist.

A Yellow Triangle is displayed beside any test that is in progress when not using the device timer to wait for its results. Test not identified is displayed below any test that has not yet been identified using the Select Test menu or by the device’s image recognition software. Audible Alerts, if enabled, will begin to sound

An audible alert can be disabled whenever an alert begins to sound b y tapping anywhere on the device’s touchscreen.

You may continue using the Deki Reader’s Analyzer application to aid with the interpretation and documentation of any rapid diagnostic test already on the device’s worklist by tapping anywhere on the test that you wish to select.

whenever a test with a countdown timer turns red.

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Adding Tests to the Worklist

Follow the instructions below to add a new test to the device’s worklist:

1. Tap the Add button in the bottom right corner of the home screen of the

Deki Reader’s Analyzer application.

2. Use the on-screen keyboard to enter an ID for the new test (if ID auto -

generation is not enabled on the Settings screen).

3. Tap the Add button to the right of the text entry field.

4. Find the test that you want to run on the Select Test menu by scrolling

through the list of options, or using the Search bar.

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5. Tap the Green Check icon when you are ready to make your selection. Then

you will see the test appear on the device’s Worklist.

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Interpreting and Documenting Tests

The Deki Reader’s Analyzer application provides on-screen instructions to aid with the interpretation and documentation of rapid diagnostic tests. Instructions may be viewed in one of the following ways:

 Immediately after adding a new test to the device’s worklist

 After tapping on a test on the device’s worklist

 When launched from another application on the device

The instructions displayed depend on how the Test Workflow settings were configured before the test was added to the device’s Worklist. You may review and change these settings on the Settings screen. Changes to these settings will only apply to tests that are subsequently added to the device’s worklist.

Instructions for the test procedure are divided into three stages:

Preparing to Test

During this stage of the testing procedure these instructions will be seen:

 Check the test’s expiry date

 Label the test, and capture an image of the labelled test

 Remove the test from the drawer

Note: If the Timer was set to Off within the Test Workflow settings before the test was added to the device’s Worklist, then instructions for this stage of the test procedure will not be shown

Run Test

If the Timer was set to On within the Test Workflow settings before the test was added to the device’s Worklist, then the following instructions for this stage of the test procedure will be seen:

 Follow the test manufacturer’s instructions and start the device timer when

ready to wait for the test’s results

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 Wait for the test’s results

 Place the test in the drawer to capture an image of its results before the

timer finishes counting down

 Remove the test from the drawer to see the device’s interpretation of the

results, and/or to enter a visual interpretation of the results

If the Timer was set to Off within the Test Workflow settings before the test was added to the device’s Worklist, then the following instructions for this stage of the test procedure will be seen:

 Place the test in the drawer to capture an image of its results when ready

 Remove the test from the drawer to see the device’s interpretation of the

results, and/or to enter a visual interpretation of the results

Results

If Device Interpretation was set to Displayed within the Test Workflow settings before the test was added to the device’s Worklist, then during this stage of the test procedure you will see the device’s interpretation of the result for each test line (as shown in the example below).

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If you would like to view the image of the test’s results that was captured by the device: Tap on the area that says Review test image.

If you would like to enter a visual interpretation for the test’s results: Tap on the area that says Enter visual interpretation.

If you would like to end the test procedure: Tap on the Done button.

If you would like to exit the test procedure, but you would like to be able to return to the test’s results from the device’s worklist: Tap on the Exit icon in the top right corner.

If Visual Interpretation was set to Mandatory within the Test Workflow settings before the test was added to the device’s Worklist, then you will need to enter a visual interpretation before ending the test procedure (as shown below).

If Device Interpretation was set to Not Displayed or Off within the Test Workflow settings before the test was added to the device’s Worklist, then during this stage of the test procedure you will be prompted to enter a visual interpretation for the control line and each of the test’s lines, instead of seeing the device’s interpretation of the test’s results.

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Errors and Device Failures

During any of the three stages of the test procedure described above, you may encounter an error while interacting with the device, or the device may fail and require service from the Support team.

background of the test procedure screen will turn red (as shown in the example on the right). You will have the option to enter a visual interpretation of the results for the test in progress. The error code at the bottom right corner of the screen can help you troubleshoot the issue with a member of the Support team.

When you encounter an error, the background of the test procedure screen will turn yellow (as shown in the example on the left). You will see information about what went wrong and what you can do to resolve the issue, or an option to complete the test procedure in a different way (for example, by entering a visual interpretation of the test’s results if the device continues to fail to capture an image for analysis). The error code at the bottom right corner of the screen can help you troubleshoot the issue with a member o f the Support team. When you encounter a device failure that can only be resolved by the Support team, the

Error and Warnings

The following errors and warning may appear during your interact ion with the Deki Reader. The Deki Reader will provide an explanation of any error detected with instructions on what to do about the error. Below are answers to frequently asked questions about some of the most common errors detected by the Deki Reader and how to prevent or correct these errors.

Errors

To be completed

Warnings

To be completed

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Maintenance and Cleaning

Maintenance

The Deki Reader is maintenance-free and has no user-serviceable parts. Only the drawer and battery are user-removeable. In the case of device failure or damage, contact Support.

Cleaning

The Deki Reader can be cleaned using 70% ethanol or 0.5% bleach, app lied using a damp, lint free cloth. Do not spray or pour solution directly onto the Deki Reader when cleaning. Ensure no excess liquid is used when cleaning as it may damage the device.

Fio recommends that the exterior instrument surfaces and the drawer interior surfaces be cleaned on a regular basis. The drawer can be removed for more extensive cleaning.

Ensure no excess liquid is used when cleaning as it may damage the device.

Clean the Deki Reader and surrounding areas immediately after possible patient sample contamination.

 Biohazard: Wear personal protective equipment and use universal

precautions while performing these procedures.

 Do not disassemble the Deki Reader.  Unplug the Deki Reader before cleaning.  Do not immerse the Deki Reader in water or cleaning solutions.  Do not spray or pour solution directly onto Reader when cleaning.  Do not immerse the Deki Reader in water or cleaning solutions.  Do not clean with soap, other solutions or other wipes.  Do not use laboratory wipes, such as Kimwipes®, as they may scratch

the display.

Cleaning the Deki Reader control strip

The Deki Reader incorporates an imaging control strip which is used to ensure that the camera system is working within allowable specifications. Occasionally the control strip may require cleaning. Follow the instructions below to clean the control strip.

1. Power off the Deki Reader

2. Remove drawer - turn the Deki Reader on its side and press and release on the symbol. Fully slide the drawer out.

3. Press the wings with your fingertips outwards and away from each other.

4. The drawer will easily slide out of the Deki Reader

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5. Using a dry lint-free swab or a lint-free tissue on the end of your finger, reach inside the Deki Reader and lightly wipe the top surface of the control strip

6. To insert the drawer back in, place the device on a flat surface and slide the drawer back in. Press symbol firmly until the drawer is fully closed.

Software Updates

Authorized device users may download and install software updates for applications available on the device. When you receive an on-screen message that a software update is available, follow the prompts to install the updates. If unable to complete the software update, please

contact Support.

 Ensure that you completed process all RDTs before attempting to

install a software update

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Appendices

Appendix A: Analytical performance characteristics

Method Comparison

The Deki Reader’s ability to detect the presence of coloured test lines, which represent positive rapid diagnostic test (RDT) results, was evaluated by means of patient sample testing at multiple sites*. The studies were designed to evaluate the Deki Reade r’s performance in interpreting RDT results compared to visual interpretation (human eye interpretation) by individual users. More than xxxx test lines from different RDT types were evaluated. The Deki Reader showed greater than xx% concordance between the human-eye interpretation of positive, negative or invalid RDT results.

 Contact Support if there appears to be a change in the performance of

the device (i.e. reduced concordance with visual interpretation).

Precision

Precision of the Deki Reader to quantitatively analyze test lines was determined using a single, custom designed cassette with two lines sprayed with colloidal gold on a nitrocellulose membrane. One line mimicked a test result of low intensity and the second line mimicked a test line of high intensity. The cassette was analyzed at x different sites representing the intended use environments on a total of six Deki Readers with x replicates per day, by x users over a x-day period.

The results are summarised in the table below:

Total Within-Reader Reader-to-Reader

High Negative CV Low Positive CV High Positive CV

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Appendix B: Technical Specifications

Dimensions Device: 260 mm D x 124 mm H x 113 mm W

Weight Device: 1.125 kg (1.375 kg with battery)

Power Supply Input: AC 100-240 V, 50-60 Hz

Battery  2-day operation

Communications  3G 800 / 850, 900

Display 5.0” TFT 24-bit WVGA with GorillaTMGlass User Interface Touchscreen Data Storage 1GB Flash memory

Packaged Box: 280 mm D x 148 mm H x 196 mm W

Packaged Box: 2.1 kg

Output: 5V / 2A

 User-replaceable  3.6 V 10.6 A/Hr  Rechargeable lithium-ion battery with built-in

protection

- AWS1700, 1900

- 2100 MHz

 Wireless network 802.11 b/g/n  Bluetooth 2.1 + EDR, 4.0 BLE  10/100 Mbps Ethernet port  2 x USB 2.0 ports

Removable Micro-SD Card Can store greater than 1,000 test results

Appendix C: Operating, Storage and Handling Conditions

Operating Conditions

 The Deki Reader is meant to be operated in a clean indoor environment  Operating Temperature: 5°C to 40°C  Operating Altitude: Up to 3,000 meters  Operating Relative Humidity: 5% to 90% (non-condensing)

Storage and Handling Conditions

 Storage and handling temperature: -20°C to 60°C

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Appendix D: Recycling and disposal

The Deki Reader operates on lithium-ion batteries and contains electronic components that should be recycled. Contact Support for proper disposal of the Deki Reader and/or its lithium-ion batteries. Disposal of old electrical and electronic equipment: The Waste Electrical and Electronic Equipment (WEEE) mark applies only to countries within the European Union and other countries with separate collection systems. The Deki Reader is labelled in accordance

you will help prevent potential negative consequences for the environment and human health that could otherwise be caused by inappropriate waste handling of this product.

with European Directive 2002/96/EC concerning waste electrical and electronic equipment. This symbol on the product or on its packaging indicates that this product is not to be treated as standard waste and thrown away. Instead, it shall be handed over to Support for the recycling of electrical and electronic equipment. By ensuring this product is disposed of correctly,

 Do not handle damage or leaking lithium-ion batteries  If the lithium-ion batteries need to be replaced, contact Support  The batteries should only be replaced by Support to ensure safety and

performance of the Deki Reader.

 Do not disassemble the Deki Reader

Note: The shipping box and packaging are recyclable; please do not dispose of them as waste.

Appendix E: Notices

The Deki Reader has been designed and manufactured to conform to the standards of safety and performance, including electromagnetic compatibility (EMC).

Notice for customers in the countries applying the European Union Directives:

The Deki Reader is compliant with the requirements of the following Standards: Essential requirements of Directive 98/79/EC for in vitro diagnostic medical devices; Safety requirements for electrical equipment, EN IEC 61010-1 & EN IEC 61010-2-101; Emission and immunity requirements of EN IEC 61326-1 & EN IEC 61326-2-6.

CE symbol goes here

North America

Compliant with UL 61010-1 & CAN/CSA C22.2 No. 61010-1. This Class B digital apparatus complies with Federal Communications Commission (FCC) CFR, Title 47, Part 15 subpart B and with Canadian ICES-003.

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ETL symbol goes here

NOTE:

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.

These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

 Reorient or relocate the receiving antenna.  Increase the separation between the equipment and receiver.  Connect the equipment into an outlet on a circuit different from that to

which the receiver is connected.

 Consult the dealer or an experienced radio/TV technician for help.

NOTICE:

This device complies with Part 15 of the FCC Rules and with Industry Canada licence- exempt RSS standard(s).

Operation is subject to the following two conditions:

1. This device may not cause harmful interference;

2. This device must accept any interference rec eived, including interference

that may cause undesired operation.

Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes:

1. l'appareil ne doit pas produire de brouillage, et

2. l'appareil doit accepter tout brouillage radioélectrique subi, même si le

brouillage est susceptible d'en compromettre le fonctionnement

NOTICE:

Changes or modifications made to this equipment not expressly approved by (manufacturer name) may void the FCC authorization to operate this equipment.