ID NOW Ref NAT-000 User Manual Rev 11 Jan 2020

INITIAL ADMIN SETUP

Power on & loading

USB with Software Update

Software Update

Initial Admin Setup

User Login

Home

ID NOW Instrument User Manual

Admin password reset

Clock reset

HOME SCREEN MENUS Home

30/Jan/2018 10:12am

User ID

Run Test

Run QC Test

Review Memory

Preferences

Setup

Log Out

Home

Run Test

Run QC Test

Review Memory

Preferences

Setup

Patient Test Results

Language

Login

New User

QC Test Results

Sound

Users

User Name

Search Results

Brightness

Assay Preference

Import Users

Export Results

About

Patient Details

Export Users

Date

Early Detection, on/off

Export Logfile

Transmission Status

Logout

Time

AutoLogout

Network

Setup

Remote Mode

Status

Connectivity

AutoSending

QC Lockout

Lot Management

Auto Print

Reset to Factory Default

*The Connectivity Status options will only appear when the instrument has been configured by the Admin to specify the port and address of the ASTM LIS, HL7, or POCT server. ID NOW Instrument User Manual

CONTENTS Warnings and Safe Use... 4 1

Introduction... 6

1.1 1.2 1.3

Intended Use...6 Product Description...6 Instrument Specifications ...7 1.3.1 Instrument ...7 1.3.2 12V Power Supply...8 1.4 Unpacking... 8 1.5 Instrument Calibration... 8 1.6 Maintenance & Cleaning...9 1.7 Components...9

2

ID NOW Instrument at a Glance...10

3

Getting Started - Setup... 12

4

™

3.1 3.2 3.3 3.4 3.5 3.6 3.7

Initial Setup... 12 Instrument Status Light ... 12 User Interface... 12 Home Screen... 13 Navigation... 13 Onscreen Keyboard... 13 Admin Setup...14

Setup Menu... 17

4.1 Log In (Admin Access Only)... 17 4.2 Users... 18 4.3 Assay Preferences (Admin Access Only)...20 4.3.1 Sample Type Selection (Admin Access Only)...21 4.3.2 Early Detection (Admin Access Only)...21 4.4 Patient Details (Admin Access Only)... 22 4.5 Date (Admin Access Only)... 22 4.6 Time (Admin Access Only)... 22 4.7 Auto Logout (Admin Access Only)... 23 4.8 Network (Admin Access Only)... 23 4.9 Remote Mode (Admin Access Only)... 24

ID NOW Instrument User Manual 1

4.10 Connectivity (Admin Access Only)... 24 4.11 Connectivity Setup Screen (Admin Access Only)... 25 4.11.1 IP Address (Admin Access Only)...25 4.11.2 Port Number (Admin Access Only)...25 4.11.3 Clear Settings (Admin Access Only)...25 4.12 Status Screen... 26 4.13 Auto-Sending Screen (Admin Access Only)... 26 4.14 Clear Sent History (Admin Access Only)... 26 4.15 QC Lockout (Admin Access Only or via POCT server) ... 26 4.16 Lot Management (Admin Access Only or via POCT server) ... 29 4.17 Auto Print (Admin Access Only) ... 31 4.18 Reset To Factory Default (Admin Access Only)... 31

5

6

7

Preferences Menu... 32

5.1 5.2 5.3 5.4 5.5

Language... 32 Sound... 32 Brightness... 33 About ... 33 Instrument Information... 33

Running a Test... 34

6.1 6.2 6.3 6.4

User Login... 34 Main Menu... 35 First Time Use... 35 Running A Test... 35

Running a QC test... 37

7.1 7.2

Run QC Test...37 QC Test Results... 38

8

Printing Test Results... 39

9

Review Memory...40

9.1

Patient Test Results...40 9.1.1 Actions Key...42 9.2 QC Test Results... 42 9.3 Search Results... 43 9.4 Export Results... 43 9.5 Export Logfile...44 2 ID NOW Instrument User Manual

10 Software Updates...45 11 Accessories... 47 11.1 Universal Printer... 47 11.2 Barcode Scanner... 47 11.3 ID NOW™ USB Drive... 47

12 Errors and Warnings...48

12.1 Errors...48 12.1.1 Power On & Loading Error...48 12.1.2 Initial Admin Setup Error...48 12.1.3 User Login Errors...49 12.1.4 Home Errors...51 12.1.5 Run Test / Run QC Test Errors...51 12.1.6 Printing Result Error...53 12.1.7 Review Memory Error...53 12.1.8 Search Results Error...54 12.1.9 Export Results & Export Logfile Errors...54 12.1.10 New User Errors...54 12.1.11 User Details Errors...55 12.1.12 Import Users Errors...56 12.1.13 Export Users Errors...56 12.1.14 Network Errors...56 12.1.15 Admin Password Errors...57 12.1.16 Miscellaneous Errors...58 12.2 Warnings... 59 12.2.1 Home Warnings...59 12.2.2 Run Test/Run QC Test Warnings...60 12.2.3 Setup Warnings...61 12.2.4 User Warnings...61

13 Symbols... 62 14 Ordering and Contact Information...64 15 Warranty... 65

ID NOW Instrument User Manual 3

WARNINGS and SAFE USE The following warnings are to be used as an aide in risk mitigation.  aution: Use only the power supply that is provided with the instrument. Use C the appropriate power supply for the region. The correct power supply is required to maintain the safety and electromagnetic compatibility of the system.  aution: The power supply that is provided should only be used with the C ID NOW Instrument.  aution: Hot Surfaces. The Sample Receiver holder in this instrument operates C at up to 60ºC (140ºF) and may cause contact burns or damage to materials in contact with this area.  aution: Always operate this instrument on a clean, flat, level and stable surface C not in direct sunlight. Do not drop the instrument. Ensure that air flow to the ventilation openings located on the back and base of the instrument are not restricted. Caution: Never move the instrument while a test is in progress.  aution: Follow proper infection control guidelines for handling all specimens C and related items. Properly dispose of all contaminated waste according to federal, state, and local requirements.  aution: Risk of electrical shock. Do not operate the instrument or the power C supply if it has been opened, damaged or exposed to moisture, condensation or rain.  aution: Do not disassemble or attempt to repair the ID NOW Instrument C or other accessories as there is a risk of damage to the instrument. This instrument does not contain serviceable parts and should be returned for repair. Disassembling the instrument will also void the warranty.  aution: Only operate the instrument for its intended purpose and in C accordance with this user manual and warnings. If the instrument is used in a manner not specified in the user manual, protection provided by the equipment will be impaired. This instrument (including power supply) is designed to operate within the manufacturer’s specifications. Do not exceed the manufacturer specifications when in use.

4 ID NOW Instrument User Manual

 aution: Position the unit with clear access to connectors. Keep connected C cables clear of work areas such that tripping or catching will not pull the unit off its work bench. The mains socket outlet intended for use with ID NOW power supply should be located near the instrument and be readily accessible. Abbott recommends that cables are disconnected when not in use for an extended period.  aution: USB and Ethernet Interfaces. If intended for connection to external C equipment, please ensure that interfaces of such equipment are separated from mains by double or reinforced insulation and present no risk of electrical shock.  aution: If any assay components are dropped, cracked, found to be damaged or C open when received, DO NOT USE and discard.  aution: Due to the high sensitivity of the assays run on the instrument, C contamination of the work area with previous positive samples may cause false positive results. Handle samples according to standard laboratory practices. Clean instruments and surrounding surfaces according to instructions provided in Section 1.6, Maintenance & Cleaning.  aution: Once reacted, the Test Base contains large amounts of amplified C sample (Amplicon). Do not disassemble the Test Base and Transfer Cartridge. In the case of a positive sample this could lead to amplicon leakage and potential false positive ID NOW test results.  aution: To avoid contamination, do not move the ID NOW Instrument during a C run or until all assay components have been removed from the instrument.

ID NOW Instrument User Manual 5

1

INTRODUCTION

1.1

Intended Use

The ID NOW™ Instrument is a fluorescence-based instrument for the processing and analysis of ID NOW tests. This document describes the setup, configuration and operation of the ID NOW Instrument, which utilizes isothermal nucleic acid technology for the qualitative detection of a range of infectious diseases. It is intended to aid in the diagnosis of these diseases.

1.2 Product Description ID NOW utilizes isothermal nucleic acid amplification technology for the qualitative detection of infectious diseases. Consumables such as Test Bases and Sample Receivers are required to run each assay. The reaction tubes in the Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. ID NOW utilizes a pair of templates (similar to primers) for the specific amplification of the target nucleic acid and a fluorescently-labeled molecular beacon designed to specifically identify the amplified targets. To perform the assay, the Sample Receiver and Test Base are inserted into the ID NOW Instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, initiating target amplification. Heating, rotation and detection is provided by the instrument, with results automatically reported. Additional assay specific information and work flows are detailed in the respective product inserts.

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1.3 Instrument Specifications 1.3.1

Instrument

Color Touch Screen

3.5” 10/100 Mbps Ethernet Port for Data Transfer

Communications

3 x USB Ports for data export, barcode reader and printer 999 patient test results

Data storage

99 QC test results Memory allows search and retrieval Archive or export via USB

Power Supply

12V DC from external AC/DC supplied plug pack DC Voltage fluctuation: ±10% DC Current consumption: 12V DC, 3.0 Amps

Dimensions Weight

8.15” W x 5.71” H x 7.64” D 207 mm W x 145 mm H x 194 mm D 3.0 kg Indoor Use

Operating Environment

15ºC to 30ºC (50ºF to 86ºF) 10% to 80% RH (non-condensing) 0m (1.01 bar) to 2000m (0.763 bar) IP20 15ºC to 30ºC (50ºF to 86ºF)

Storage

10% to 80% RH (non-condensing) 0m (1.01 bar) to 2000m (0.763 bar)

ID NOW Instrument User Manual 7

1.3.2

12V Power Supply

Rated input voltage:

100-240VAC

Rated input frequency:

50/60Hz

Rated input current:

1.2 Amps

Operating environment:

As per instrument

Storage environment:

As per instrument

Output voltage:

12V

Output current:

3.5 Amps

1.4 Unpacking Unpack the ID NOW Instrument and place on a clean, flat, level and stable surface within reach of an electrical outlet. The ID NOW Instrument has a carrying handle located on the back of the instrument for transport purposes. Use the carrying handle when removing the instrument from the box and when transporting short distances. Place instrument in a location where the air vents located in the back of the instrument will not be blocked. Avoid placing the instrument in direct sunlight. Inspect for any obvious signs of damage. Report any damage immediately to Abbott. Allow the instrument to equilibrate to room temperature for at least 30 minutes.

1.5 Instrument Calibration The ID NOW Instrument is factory calibrated and does not require any further calibration and verification. However, if the instrument was transported or moved, a performance check using ID NOW positive and negative controls is recommended to ensure proper functionality.

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1.6 Maintenance & Cleaning The ID NOW Instrument is maintenance-free and has no serviceable parts. In the case of instrument failure or damage, contact Abbott Technical Support. Acceptable cleaning agents include the following: •

70% ethanol - available in commercial wipes or on a damp, lint free cloth

•

10% bleach - on a damp, lint free cloth only

Do not spray or pour solution directly onto instrument when cleaning. Ensure no excess liquid is used when cleaning as it may damage the instrument. Abbott recommends that the exterior instrument surfaces and the surfaces visible under the open lid be cleaned daily. Clean surrounding bench area. Clean instrument and surrounding areas immediately after possible patient sample contamination. Do not disassemble the instrument for cleaning. Do not immerse in water or cleaning solutions. Do not clean with soap or other solutions.

1.7 Components The following items are supplied with the ID NOW Instrument: •

Power Supply and Adaptor

•

ID NOW Instrument User Manual

•

ID NOW Instrument Quick Start Guide

ID NOW Instrument User Manual 9

2 ID NOW INSTRUMENT at a GLANCE ™

ID NOW Instrument, Front View ™

Lid

LCD Color Display Screen

Test Base Holder

Sample Receiver Holder

Audio Speaker

LED Status Indicator

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ID NOW Instrument, Back View ™

USB Connection

Carrying Handle

Power Connection Power Button

Ethernet Connection

USB Connection x 2

ID NOW Instrument User Manual 11

3 GETTING STARTED - SETUP For unpacking and calibration, see Sections 1.4 and 1.5.

3.1 Initial Setup Connect the 12V power supply to the instrument. Plug the appropriate, country specific adapter into an appropriate electrical outlet.

Power Up: Once the power is connected, press and hold the Power Button on the right side of the instrument to power up and start the instrument. Once the instrument is running, it may be turned off (shut down) by pressing and holding the Power Button for 3 seconds or longer. If the unit is unattended for one hour, the instrument will switch to power save mode, and the screen will go black. Touch the screen to return the unit to active display operation.

3.2 Instrument Status Light The lower right side of the front panel of the ID NOW Instrument includes a white light. This light should illuminate immediately when the instrument is powered up. The light statuses are: State

Indication

Slow flash

Starting up/ heaters not at temperature

On solid

Heaters at temperature

Fast flash

Software updates, Hardware fault, or shutting down

3.3 User Interface All Operator interactions with the ID NOW Instrument are performed using the instrument touch screen.

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3.4 Home Screen Home Screen: Displays buttons for access to: Home

• • • • • •

30/Jan/2018 10:12am

User ID

Run Test

Run QC Test

Review Memory

Preferences

Setup

Log Out

Run Test Run QC Test Review Memory Preferences Setup (Admin Access Only) Log Out

The current set time and date is displayed in the top right hand corner of the screen.

Main Menu – Home Screen

3.5 Navigation

Up & Down Arrows:

Preferences Language

English

Sound

Enabled

Brightness

Enable navigation to scroll through menus and increase/decrease setting values.

50%

Home:

About

Select Home at any time to return to the Home screen.

Example of Navigation Bar

3.6 Onscreen Keyboard

Q

#

W

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T

Y

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O

P

A

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D

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K

L

Z

X

C

V

B

N

M

1

#

2

3

4

5

6

7

8

9

0

/

:

;

(

)

$

&

@

“

+

=

.

,

?

!

‘

123

ABC

Onscreen QWERTY Keyboard & Numeric Keypad

The Onscreen QWERTY Keyboard & Numeric Keypad enable user input into the ID NOW Instrument. Press ‘123’ or ‘ABC’ to swap between text and number entry. Note: Barcode input will operate at any time in these screens and can add text as if entered via the onscreen keypad. Note: If Chinese language is selected, the Pinyin keyboard will be available. If Japanese is selected, Romaji will be available.

ID NOW Instrument User Manual 13

3.7 Admin Setup Creating the Admin ID Create Admin Password

Q

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The instrument requires one Admin user to be set up. The user-name is automatically set to ‘Admin’, but the password must be chosen. Admin User Name: Admin Admin Password chosen by Admin.

123

After power-up, the Create Admin Password screen will be displayed. The Admin user must type in their chosen password and press . Passwords are case-sensitive and must be alphanumeric. The password cannot contain spaces. Passwords must be 2-20 characters. The instrument will ask for confirmation of the password. If password is correct, press to advance to the next screen. If password is incorrect, press Cancel to return to the Create Admin Password screen. The Admin can set a rescue password in case the original is lost or forgotten.

Rescue Password Would you like to define a Rescue Password that can restore access if the Admin password is lost?

No

Yes

Use keyboard to enter the rescue password and reset password.

Recovery Key Please refer to user manual.

If rescue password is lost, an error screen will indicate 'Password Not Recognized'. Admin can choose 'Reset' and a Recovery Key will be automatically generated by the instrument.

Recovery Key: ####-####-####

Cancel

OK

Enter Reset Code [####-####-####]

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Contact Abbott Technical Support with the Recovery Key. A Reset Code will be provided. Use Keyboard to enter reset code and press to advance to Enter a New Password.

123

14 ID NOW Instrument User Manual

Setting the Date Set the correct date using the up and down arrow keys and the touch screen to move between day, month and year.

Date

3 / NOV / 2013

This screen will be displayed automatically following creation of Admin Password. OK

Press OK to advance.

Setting the Time Time 12 Hour

11 : 35

24 Hour

PM

Set the correct time using the up and down arrow keys, and choose between a 12 Hour or 24 Hour display using the touch screen. This screen will be displayed automatically once the date is set.

OK

Press OK to advance.

Self Test Self Test Running self test, please wait ...

Self Test Close lid to proceed.

The instrument will now run a Self Test before proceeding to the Home screen.

If the instrument lid is open, the instrument will prompt to close the lid before running the Self Test. The Self Test will not proceed until the lid is closed.

ID NOW Instrument User Manual 15

Home Home

30/Jan/2018 10:12am

User ID

Run Test

Run QC Test

Review Memory

Preferences

Setup

Log Out

When initial set-up is complete, the Home screen will be displayed, with the current time and date shown in the top right, and User ID in top left corner of the screen. Abbott recommends that the Admin selects Setup to finish configuring the instrument and to add additional users. See Section 4 for details.

Alternatively, the Admin can run a test by selecting Run Test. When an assay or the instrument is used for the first time, or following a software upgrade, the user is required to run both a positive and a negative successful QC test before patient testing is allowed. See Sections 6 and 7 for details. If not ready to continue set up or run tests, Abbott recommends that the Admin logs out by selecting Log Out.

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4 SETUP MENU Home>Setup Setup Login

ID & Password Required

Users

99

The Setup screen allows the Admin to configure the instrument. Use the up and down arrows to scroll through menus. Settings are saved even when power is off.

Assay Preferences

Settings include: • Login • Users • Assay Preferences • Patient Details • Date • Time • Auto-logout • Network • Remote Mode • Connectivity • QC Lockout • Lot Management • Auto-Print • Reset to Factory Default

Patient Details

Chosen options are displayed to the right of each setting.

4.1 Log In (Admin Access Only) Home>Setup>Login

Log In allows the Admin to choose User ID password requirements to allow access to the instrument.

Log In

User ID Only User ID & Password

OK

If Users do not require passwords, select ‘User ID Only’ and press OK. If a password is preferred, select ‘User ID & Password’ and press OK.

The selected option will apply to all Users with the exception of the Admin, who will always be required to use a password when logging on as ‘Admin’. If the system is changed from User ID & Password to User ID Only, existing passwords are retained in the event the Admin selects User ID & Password in the future. If the system is changed from User ID Only to User ID & Password, user passwords are set to ‘password’ as a default, if a password has not been set previously for the user. The Admin can change each User’s password individually, as needed. ID NOW Instrument User Manual 17