Abbott ID NOW NAT-024 Instrument User Manual

NAT-024

INSTRUMENT USER MANUAL

ID NOW

™

ID NOW Instrument User Manual

ID NOW

™

Instrument User Manual

USB with

Software

Update

Home

Clock

reset

User

Login

Software

Update

Power on

&

loading

Initial

Admin

Setup

Admin

password

reset

INITIAL ADMIN SETUP

ID NOW Instrument User Manual

HOME SCREEN MENUS

Home

User ID

30/Jan/2018

10:12am

Run

Test

Run QC

Test

Review

Memory

Preferences Setup Log Out

ID NOW Instrument User Manual

*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.

Patient

Test

Results

Review

Memory

Export

Logle

Export

Results

Search

Results

QC Test

Results

Logout

Home

Run

QC Test

Run

Test

Export

Users

Import

Users

User

Name

New

User

Remote

Mode

Auto-

Logout

Network

Time

Date

Patient

Details

Users

Login

Setup

Preferences

About

Brightness

Sound

Language

Assay

Preference

Transmission

Status

Setup

Status

Auto-

Sending

Connectivity

Lot

Management

Auto Print

Reset to

Factory

Default

Early

Detection,

on/o

QC

Lockout

ID NOW Instrument User Manual 1

CONTENTS

Warnings and Safe Use ............................................................... 4

1 Introduction .......................................................................... 6

1.1 Intended Use ...................................................................................................6

1.2 Product Description .......................................................................................6

1.3 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

3.1 Initial Setup ................................................................................................... 12

3.2 Instrument Status Light .............................................................................. 12

3.3 User Interface ............................................................................................... 12

3.4 Home Screen ................................................................................................ 13

3.5 Navigation .....................................................................................................13

3.6 Onscreen Keyboard ...................................................................................... 13

3.7 Admin Setup .................................................................................................14

4 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

4.10 Connectivity (Admin Access Only) ..........................................................24

2 ID NOW Instrument User Manual

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.5 QC Lockout (Admin Access Only or via POCT server) ........................ 26

4.16 Lot Management (Admin Access Only or via POCT server) ................ 28

4.17 Auto Print (Admin Access Only) ..............................................................30

4.18 Reset To Factory Default (Admin Access Only)....................................... 31

5 Preferences Menu .............................................................. 32

5.1 Language ....................................................................................................... 32

5.2 Sound ............................................................................................................ 32

5.3 Brightness ..................................................................................................... 33

5.4 About ........................................................................................................... 33

5.5 Instrument Information............................................................................... 33

6 Running a Test ....................................................................34

6. User Login.....................................................................................................34

6.2 Main Menu ................................................................................................... 35

6.3 First Time Use .............................................................................................. 35

6.4 Running A Test ............................................................................................. 35

7 Running a QC Test ............................................................. 37

7.1 Run QC Test .................................................................................................37

7.2 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

ID NOW Instrument User Manual 3

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

4 ID NOW Instrument User Manual

The following warnings are to be used as an aide in risk mitigation.

Caution: 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.

Caution: The power supply that is provided should only be used with the

IDNOW Instrument.

Caution: Hot Surfaces. The Sample Receiver holder in this instrument operates

at up to 60ºC (140ºF) and may cause contact burns or damage to materials in

contact with this area.

Caution: Always operate this instrument on a clean, flat, level and stable surface

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.

Caution: Follow proper infection control guidelines for handling all specimens

and related items. Properly dispose of all contaminated waste according to

federal, state, and local requirements.

Caution: Risk of electrical shock. Do not operate the instrument or the power

supply if it has been opened, damaged or exposed to moisture, condensation or

rain.

Caution: Do not disassemble or attempt to repair the ID NOW Instrument

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.

Caution: Only operate the instrument for its intended purpose and in

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.

WARNINGS and SAFE USE

ID NOW Instrument User Manual 5

Caution: Position the unit with clear access to connectors. Keep connected

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.

Caution: USB and Ethernet Interfaces. If intended for connection to external

equipment, please ensure that interfaces of such equipment are separated from

mains by double or reinforced insulation and present no risk of electrical shock.

Caution: If any assay components are dropped, cracked, found to be damaged or

open when received, DO NOT USE and discard.

Caution: Due to the high sensitivity of the assays run on the instrument,

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.

Caution: Once reacted, the Test Base contains large amounts of amplified

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.

Caution: To avoid contamination, do not move the IDNOW Instrument during a

run or until all assay components have been removed from the instrument.

6 ID NOW Instrument User Manual

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.

1 INTRODUCTION

ID NOW Instrument User Manual 7

1.3 Instrument Specifications

1.3.1 Instrument

Color Touch Screen 3.5”

Communications

10/100 Mbps Ethernet Port for Data Transfer

3 x USB Ports for data export, barcode reader and

printer

Data storage

999 patient test results

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

8.15” W x 5.71” H x 7.64” D

207 mm W x 145 mm H x 194 mm D

Weight 3.0 kg

Operating

Environment

Indoor Use

15°C to 30°C (50°F to 86°F)

10% to 80% RH (non-condensing)

0m (1.01 bar) to 2000m (0.763 bar)

IP20

Storage

15°C to 30°C (50°F to 86ºF)

10% to 80% RH (non-condensing)

0m (1.01 bar) to 2000m (0.763 bar)

8 ID NOW Instrument User Manual

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.

ID NOW Instrument User Manual 9

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

• 70% isopropanol - 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

10 ID NOW Instrument User Manual

ID NOW

™

Instrument, Front View

2 ID NOW

™

INSTRUMENT at a

GLANCE

Lid

Test Base

Holder

Sample Receiver

Holder

LED Status Indicator

LCD Color

Display Screen

Audio

Speaker

ID NOW Instrument User Manual 11

ID NOW

™

Instrument, Back View

USB Connection

Power

Button

USB Connection x 2

Ethernet

Connection

Carrying Handle

Power

Connection

12 ID NOW Instrument User Manual

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.

ID NOW Instrument User Manual 13

3.4 Home Screen

Home Screen: Displays buttons for access to:

Home

User ID

30/Jan/2018

10:12am

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

Preferences

Language

Sound

Brightness

English

Enabled

50%

About

Example of Navigation Bar

Up & Down Arrows:

Enable navigation to scroll through

menus and increase/decrease

setting values.

Home:

Select Home at any time to return

to the Home screen.

3.6 Onscreen Keyboard

QWERTYUI

#ZXCVBNM

OP

ASDFGH JKL

123

12345678

#+=. ,?!‘

90

/:;()$&@ “

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.

14 ID NOW Instrument User Manual

3.7 Admin Setup

Creating the Admin ID

QWERTYUI

#ZXCVBNM

OP

ASDFGH JKL

123

Create Admin Password

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.

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.

Rescue Password

Yes

No

Would you like to dene a Rescue

Password that can restore access

if the Admin password is lost?

The Admin can set a rescue password in case the

original is lost or forgotten.

Recovery Key

OKCancel

Please refer to user manual.

Recovery Key:

####-####-####

Use keyboard to enter the rescue password and reset

password.

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.

QWERTYUI

#ZXCVBNM

OP

ASDFGH JKL

123

Enter Reset Code

[####-####-####]

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.

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Abbott ID NOW NAT-024 Instrument User Manual

Abbott ID NOW NAT-024 Instrument User Manual

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