UM - ABBOTT - ID NOW Instrument

ID NOW
Instrument User Manual
NAT-000
ID NOW Instrument User Manual

Initial Admin Setup
USB with Power on

Software &
Update loading
Initial Admin
Software User Clock
Admin password
Update Login reset
Setup reset
Home

Home Screen Menus
Home 30/Jan/2018
User ID 10:12am
Run Run QC Review

Test Test Memory
Preferences Setup Log Out
Home
Run Run Review Preferences Setup Logout

Test QC Test Memory
Patient
Language New
Test Login
User
Results
QC Test Sound User

Users
Results Name
Search Brightness Assay Import

Results Preference Users
Export Export
About Date
Results Users
Early
Export
Time Detection,
Logfile
on/off
LIS Auto-
Status* Logout
Network
Remote
Setup
Mode
Connectivity Status
QC Auto-
Lockout
Sending
Lot
Management
Reset to
Factory
Default
*The "LIS /POCT Status" options will only appear when the instrument has been
configured by the Admin to specify the port and address of the LIS /POCT server.

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.............................................................. 16
4.1 Log In (Admin Access Only)...........................................................16
4.2 Users (Admin Access Only)............................................................17
4.3 Assay Preferences (Admin Access Only)........................................19
4.3.1 Sample Type Selection (Admin Access Only)..........................20
4.3.2 Early Detection (Admin Access Only)......................................20
4.4 Date (Admin Access Only)..............................................................21
4.5 Time (Admin Access Only)..............................................................21
4.6 Auto Logout (Admin Access Only)..................................................21
4.7 Network (Admin Access Only)........................................................22
4.8 Remote Mode (Admin Access Only)...............................................22
4.9 Connectivity (Admin Access Only).................................................23
4.10 LIS/POCT Setup Screen (Admin Access Only)..............................23
4.10.1 IP Address (Admin Access Only).........................................24
4.10.2 Port Number (Admin Access Only)......................................24
4.10.3 Clear Settings (Admin Access Only)....................................24
ID NOW Instrument User Manual 1
4.11 Status Screen................................................................................25
4.12 Auto-Sending Screen (Admin Access Only)..................................25
4.13 Clear Sent History (Admin Access Only).......................................25
4.14 QC Lockout (Admin Access Only) ................................................25
4.15 Lot Management (Admin Access Only) ........................................28
4.16 Reset To Factory Default (Admin Access Only).............................30
5 Preferences Menu................................................... 31
5.1 Language........................................................................................31
5.2 Sound.............................................................................................31
5.3 Brightness......................................................................................32
5.4 About .............................................................................................32
5.5 Instrument Information...................................................................32
6 Running A Test......................................................... 33
6.1 User Login......................................................................................33
6.2 Main Menu......................................................................................34
6.3 First Time Use................................................................................34
6.4 Running A Test...............................................................................34
7 Running A QC Test.................................................. 36
7.1 Run QC Test...................................................................................36
7.2 QC Test Results..............................................................................37
8 Printing Test Results............................................... 38

9 Review Memory....................................................... 39
9.1 Patient Test Results........................................................................39
9.1.1 Actions Key...............................................................................40
9.2 QC Test Results..............................................................................41
9.3 Search Results...............................................................................41
9.4 Export Results................................................................................42
9.5 Export Logfile.................................................................................43
2 ID NOW Instrument User Manual

10 Software Updates.................................................... 44
11 Accessories............................................................. 46
11.1 Alere™ Universal Printer..................................................................46
11.2 Barcode Scanner...........................................................................46
11.3 ID NOW USB Drive........................................................................46
12 Errors and Warnings............................................... 47

12.1 Errors.............................................................................................47
12.1.1 Power On & Loading Error.................................................47
12.1.2 Initial Admin Setup Error....................................................47
12.1.3 User Login Errors...............................................................48
12.1.4 Home Errors.......................................................................51
12.1.5 Run Test / Run QC Test Errors...........................................52
12.1.6 Printing Result Error...........................................................55
12.1.7 Review Memory Errors.......................................................55
12.1.8 Search Results Error..........................................................56
12.1.9 Export Results & Export Logfile Errors..............................56
12.1.10 New User Errors.................................................................57
12.1.11 User Details Errors.............................................................58
12.1.12 Import Users Errors............................................................59
12.1.13 Export Users Errors............................................................59
12.1.14 Network Errors...................................................................60
12.1.15 Admin Password Errors.....................................................61
12.1.16 Miscellaneous Errors..........................................................61
12.2 Warnings........................................................................................63
12.2.1 Home Warnings.................................................................63
12.2.2 Run Test/Run QC Test Warnings........................................64
12.2.3 Setup Warnings..................................................................65
12.2.4 User Warnings....................................................................66
13 Symbols.................................................................... 67
14 Ordering and Contact Information......................... 69
15 Warranty................................................................... 70

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.
C
Use 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

C
operates 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
C
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.
aution: Follow proper infection control guidelines for handling all

C
specimens 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

C
power 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.

aution: Position the unit with clear access to connectors. Keep
C
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.
aution: USB and Ethernet Interfaces. If intended for connection to

C
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.
aution: If any assay components are dropped, cracked, found to be

C
damaged or 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

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

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.

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
99 QC test results
Data storage
Memory allows search and retrieval
Archive or export via USB
12V DC from external AC/DC supplied
plug pack
Power Supply
DC Voltage fluctuation: ±10%
DC Current consumption: 12V DC, 3.0 Amps
8.15” W x 5.71” H x 7.64” D
Dimensions
207 mm W x 145 mm H x 194 mm D
Weight 3.0 kg
Indoor Use
15ºC to 30ºC (50ºF to 86ºF)
10% to 80% RH (non-condensing)
Operating
Environment 0 to 2000m (0 to 6,562 ft.) altitude
Pressure 0.763 bar (2000m) to 1.01 bar
(sea level)
IP20
15ºC to 30ºC (50ºF to 86ºF)

10% to 80% RH (non-condensing)
Storage Pressure 0.763 bar (2000m) to 1.01 bar
(sea level)
0 to 2000m (0 to 6,562 ft.) altitude

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.

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.
The ID NOW Instrument can be cleaned using 70% ethanol or 10% bleach
solution, on a damp, lint free cloth. 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

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

ID NOW Instrument, Back View
USB Connection Carrying Handle
Power
Connection
Power
Button Ethernet
Connection
USB Connection x 2

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 Hardware fault or shutting down
3.3 User Interface

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

3.4 Home Screen
Home Screen: Displays buttons for access to:
Home
User ID
30/Jan/2018
10:12am
• Run Test
• Run QC Test
Run Run QC Review
Test Test Memory
• Review Memory
• Preferences
• Setup (Admin Access Only)
• Log Out
The current set time and date is displayed in
Main Menu – Home Screen
the top right hand corner of the screen.
3.5 Navigation
Preferences Up & Down Arrows:
Language English Enable navigation to scroll
Sound Enabled through menus and increase/
Brightness 50% decrease setting values.
About Home:
Select Home at any time to
Example of Navigation Bar return to the Home screen.
3.6 Onscreen Keyboard
Q W E R T Y U I O P 1 2 3 4 5 6 7 8 9 0
A S D F G H J K L / : ; ( ) $ & @ “
# Z X C V B N M # + = . , ? ! ‘
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.

3.7 Admin Setup
Creating the Admin ID
Create Admin Password The instrument requires one Admin user to be

set up. The user-name is automatically set to
Q W E R T Y U I O P
‘Admin’, but the password must be chosen.
A S D F G H J K L Admin User Name: Admin
# Z X C V B N M 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.
Note: If the Admin password is forgotten the Admin must contact Abbott
Technical Support.
Setting the Date

Date Set the correct date using the up and down
arrow keys and the touch screen to move
between day, month and year.
3 / NOV / 2013
This screen will be displayed automatically
following creation of Admin Password.
OK Press OK to advance.
Setting the Time

Time Set the correct time using the up and down
arrow keys, and choose between a 12 Hour or
12 Hour 24 Hour
24 Hour display using the touch screen.
11 : 35 PM
This screen will be displayed automatically
once the date is set.
OK Press OK to advance.

Self Test
Self Test The instrument will now run a Self Test before
Running self test,
proceeding to the Home screen.
please wait ...
Self Test If the instrument lid is open, the instrument

Close lid to
will prompt to close the lid before running the
proceed. Self Test. The Self Test will not proceed until
the lid is closed.
Home
Home
User ID
30/Jan/2018
10:12am
When initial set-up is complete, the Home
screen will be displayed, with the current time
Run Run QC Review
Test Test Memory
and date shown in the top right, and User ID in
top left corner of the screen.
Preferences Setup Log Out 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.

4 Setup Menu
Home>Setup
Setup The Setup screen allows the Admin to
Login ID & Password Required
configure the instrument. Use the up and down
Users 99
arrows to scroll through menus.
Assay Preferences Settings are saved even when power is off.
Date 01/Dec/2017 Settings include:
• Login
• Users
Setup
• Assay Preferences
Time 1:13 pm
• Date
Auto-logout 5 min
• Time
Network 100.100.100.100
• Auto-logout
Remote Mode
• Network
• Remote Mode
Setup
• Connectivity
Connectivity
• QC Lockout
QC Lockout
• Lot Management
Lot Management
• Reset to Factory Default
Reset to Factory Default Chosen options are displayed to the right of
each setting.
4.1 Log In (Admin Access Only)

Home>Setup>Login
Log In Log In allows the Admin to choose User ID
password requirements to allow access to the
instrument.
User ID Only
User ID & Password If Users do not require passwords, select
‘User ID Only’ and press OK. If a password
OK 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.

4.2 Users (Admin Access Only)
Home>Setup>Users
Users Users
New User JAN
ADMIN CINDY
Import Users MARSHA
Export Users
The User Menu allows the Admin to add, delete and edit the list of
instrument users.
New User: Home>Setup>Users>New User

Enter User ID or Scan Enter the User ID (for example, the User’s
name), or scan User ID using an electronic
Q W E R T Y U I O P
barcode, then press .
A S D F G H J K L The User ID must be 2 to 20 characters and
# Z X C V B N M alphanumeric. User IDs are not case sensitive.
123
Enter Password If required, the instrument will prompt Admin to

enter the password and press .
Q W E R T Y U I O P Passwords are case-sensitive and must be
A S D F G H J K L alphanumeric. The password cannot contain
# Z X C V B N M spaces.
123
Note: A unique User ID is required for each user. If a duplicate User ID is

entered, the instrument will prompt to use a different ID. Only the Admin
can change a User’s password.
User Details: Home>Setup>Users

User Details Select a current User and press OK to view
User Name: James
User details, change User's password or to
delete the User.
Delete
OK

User Details The User’s password will be displayed,
User Name: James
and can be changed by pressing ‘Change
Password: 123password
Password’.
Change Password
Delete
OK
Enter Existing Password Enter existing password and press .

Then enter new password and press .
Q W E R T Y U I O P Passwords are case-sensitive and must be
A S D F G H J K L alphanumeric. The password cannot contain
# Z X C V B N M spaces.
123
Enter New Password Note: If the Admin user has been selected,
neither the password nor the delete button will
Q W E R T Y U I O P
be displayed on this screen.
A S D F G H J K L Press to return to the previous screen.
# Z X C V B N M
123
Deleting a User: Home>Setup>Users

User Details To delete a current User, press delete.
User Name: James
A warning will be displayed confirming to
Password: 123password
delete user.
Change Password Press OK to delete User and return to the
Delete Setup Users screen.
OK Press Cancel to return to the Users screen
without deleting the user.
Note: Deleting a User is permanent. Once deleted, the User profile
will be lost.
Test results already stored in the instrument performed by this User will not
be affected.

Export Users: Home>Setup>Users>Export Users
Export Users Export all configured users to a USB drive
Exporting users to USB device ...
connected to the instrument.
This user list can then be imported to another
ID NOW Instrument, to the same instrument
following a reset to factory settings or after
software upgrades.
Press OK to return to the Users screen.
Export Users
Exported 12 users.
OK
Import Users: Home>Setup>Users>Import Users

Import Users Import a complete user list that has been
Importing users from USB
exported from an ID NOW Instrument, using a
device... USB drive connected to the instrument.
Press OK to return to the User screen.
Note: Only Users exported from an ID NOW
Instrument can be imported.
Import Users
Imported 8 users.
OK
4.3 Assay Preferences (Admin Access Only)

Home>Setup>Assay Preferences
Select Test The Assay Preferences Menu allows the
ID NOW Assay 1
Enabled Admin to enable or disable a particular assay.
User Select
ID NOW Assay 2 Enabled The Admin can select the desired assay from
Swab
ID NOW Assay 3 Enabled the Select Test menu.

User Select

Home>Setup>Assay Preferences
Strep A Preferences When the Assay Enabled indicator is set to
on (default mode) the assay is selected and
Assay Enabled
will appear on the Assay menu choice. In this
example, Strep A is enabled.
Sample Type Swab
OK
4.3.1 Sample Type Selection (Admin Access Only)

Home>Setup>Assay Preferences> <Assay Name> >Sample Type
If the assay has more than one sample type available to them, the Admin will be
allowed to choose the applicable sample types for that assay on the instrument.
Sample Type - Flu A & B As an example, the Influenza A & B test is
shown.
Swab
Viral Transport Media

If Swab is selected, only the swab method will
Select Per Test be shown when running a test.
If Viral Transport Media (VTM) is selected, only
the VTM method will be shown when running
OK
a test.
Choose Select per Test if the instrument is intended to run both Swabs
and VTM samples. Users will be required to select the appropriate Sample
Type each time they run a test.
Press OK to save the settings and return to the Setup Menu.
4.3.2 Early Detection (Admin Access Only)

Home>Setup>Assay Preferences> <Assay Name>
Influenza A & B Preferences Some Assays offer an Early Detection feature:
The Early Detection feature allows a multi-
Assay Enabled
target assay to end as soon as a positive result
Early Detection Enabled
is detected in one of the targets. The second
target will not be reported.
Sample Type Swab
TO TURN ON EARLY DETECTION: ensure that
OK the Early Detection Enabled box is ticked.
TO TURN OFF EARLY DETECTION: ensure that
the Early Detection Enabled box is clear.

4.4 Date (Admin Access Only)
Home>Setup>Date
Date The Date Menu allows the Admin to set the
correct date.
Use the up and down arrow keys and the touch
3 / NOV / 2013 screen to change the date and move between
day, month and year.
Press OK to save the settings and return to the
OK Setup Menu.
4.5 Time (Admin Access Only)

Home>Setup>Time
Time The Time Menu allows the Admin to set the
correct time.
12 Hour 24 Hour
Use the up and down arrow keys and touch
11 : 35 PM
screen to change the time and choose
between a 12 Hour or 24 Hour display.
Cancel OK
Setup Menu.
4.6 Auto Logout (Admin Access Only)

Home>Setup>Auto-Logout
Auto-Logout The Auto-Logout Menu allows the Admin to
select when the instrument automatically logs a
User out after 5 minute and up to 60 minutes of
5 Min inactivity. Use the up and down arrow keys to
change Auto-Logout time in 5 minute intervals.
Cancel OK
Setup Menu.

4.7 Network (Admin Access Only)
Home>Setup>Network
Network The Network menu allows the Admin to
DHCP
configure the network settings on the
Static Instrument.
IP Address: 10.0.1.121
Subnet Mask: 255.255.0.0 Functions supported include:
Gateway: 10.0.1.121
DHS Address: 255.255.255.0 • Select between DHCP and Static IP
address assignment.
Cancel OK
• Configure IP Address.
Edit Addresses • Configure Subnet Mask.
IP Address 100.100.100.100 • Configure Gateway
Subnet Mask 255.255.255.0
• Configure DNS
Gateway 100.100.100.100
The default is DHCP. To switch to static IP, an
DNS Address 100.100.100.100
IP address, Subnet Mask, Gateway, or DNS
Cancel OK
Address must be entered manually using Edit
IP Address Addresses screen. The details will show on
10.0.1.121
right of screen, if set.
1 2 3 4 5 6 7 8 9 0 Press to save the settings and return to the
/ : ; ( ) $ & @ “ Setup Menu.
# + = . , ? ! ‘
ABC
Some networks require registration of a device before they are assigned

an IP address. Please consult with your Network Administrator or IT Help
Desk, as needed.
4.8 Remote Mode (Admin Access Only)

Home>Setup>Remote Mode
Remote Mode Remote Mode is currently not available for use
Remote Mode Enabled
by end users.
Client connections: 0
IP Address: 172.16.0.161
Cancel

4.9 Connectivity (Admin Access Only)
Records may be transmitted to a Laboratory Information System (LIS) or
Point of Care Data Management System (POC DMS).
Icons Icons appear at the upper right on certain

screens when LIS/POCT activity occurs.
The top icon indicates an activity is in progress.
The middle icon indicates a successful
LIS/POCT activity has completed. The bottom
icon indicates an error occurred during an
LIS/POCT activity.
Home>Setup>Connectivity
Connectivity The Connectivity Menu allows the Admin to
configure, edit, or control sending messages
ASTM LIS to a Laboratory Information System or the
POCT-1A Point of Care Data Management system via the
Ethernet network connection. Choose either
ASTM LIS or POCT-1A and press OK to select.
OK
Connectivity
Setup
Status nnn Unsent
Auto-Sending Enabled, 5 Min
Clear Sent History
4.10 LIS/POCT Setup Screen (Admin Access Only)

Home>Setup>Connectivity>Setup
Setup The Admin can set the IP Address and Port
IP Address 100.100.100.100
corresponding to the Laboratory Information
Port Number 51122
System or Point of Care Data Management
System.
Test Connection Success
Clear Settings Test Connection can be used to determine if

Cancel the instrument can reach a compatible server
at the configured address and port.
Changes to the IP Address and Port Number
are only persisted if the user presses the OK
button; Cancel will discard changes.

4.10.1 IP Address (Admin Access Only)
Home>Setup>Connectivity Setup>IP Address
IP Address Note: This is for entering the IP address of
10.0.1.121
the LIS or POCT server, not of the ID NOW
1 2 3 4 5 6 7 8 9 0
instrument itself.
/ : ; ( ) $ & @ “
# + = . , ? ! ‘ delete
ABC Space
4.10.2 Port Number (Admin Access Only)

Home>Setup>Connectivity Setup>Port Number
Port Number
51122
1 2 3 4 5 6 7 8 9 0
/ : ; ( ) $ & @ “
# + = . , ? ! ‘ delete
ABC Space
4.10.3 Clear Settings (Admin Access Only)

Home>Setup>Connectivity Setup>Clear Settings
Warning Selecting OK will return LIS/POCT IP Address
and LIS/POCT Port Number to “Not Set” and
Are you sure you want to clear
all the current connection return to the Connectivity menu.
settings?
Cancel OK

4.11 Status Screen
Home>Setup>Connectivity Status
Status Status shows how many total records are
Unsent Results: 2
in memory and how many have not been sent
Total Results: 4 to the LIS/POCT server. This number includes
both QC test results and patient test results.
Test Connection Success
Test Connection tests connectivity to the server,
Send All Unsent
as seen under Connectivity Setup.
Back Stop
Send All Unsent sends all records to the server
that have not previously been successfully sent.
4.12 Auto-Sending Screen (Admin Access Only)

Home>Setup>Connectivity>Auto-Sending
Auto-Sending When Auto-Sending is enabled, the instrument
Auto-Sending
will regularly attempt to send all unsent records
to the LIS/POCT server at the configured
period. The available selections are 5 Minutes,
Auto-Send Period: 5 Min
15 Minutes, 30 Minutes, 1 Hour, and 1 Day.
OK
4.13 Clear Sent History (Admin Access Only)

Home>Setup>Connectivity>Clear Sent History
Clear Sent History erases the time and date record for all results sent
successfully.
This feature may be used if switching to a new laboratory information
system or if the user wants to re-transmit all test results.
4.14 QC Lockout (Admin Access Only)

Home>Setup>QC Lockout
The Admin can enable the QC Lockout function to ensure that a QC
negative and positive test must be run before patient testing is allowed on
each new assay lot.
Setup Select QC Lockout to configure QC Lockout
Connectivity
options.
QC Lockout
Lot Management
Reset to Factory Default

QC Lockout Select each assay from the QC Lockout menu
ID NOW Assay 1 Off
to configure QC Lockout.
ID NOW Assay 2 Off
ID NOW Assay 3 Off
QC Lockout - ID NOW Assay 1 The QC Lockout Menu allows the Admin to

configure QC lockout options for the assay
Warn Lockout Off selected.
Units Days
Select Off to disable QC Lockout (default)
Frequency 100 Select Lockout or Warn to prevent any patient
Cancel OK
tests being performed with a new lot until
negative and positive QC has passed for that
lot.
The QC Lockout function when enabled (warn
or lockout mode) also allows the Admin to
configure a testing interval for the assay
chosen (lot independent).
In the Lockout mode when the assay
frequency expires, the user will be prompted to
run a QC test for that particular assay before a
patient test can be run.
In the Warn mode, when the assay frequency
expires it will present the user with an option to
proceed.
Units are set as either days or number of tests
performed by pressing the units button.
Frequency can be set between 1-1000. (If
testing interval is not required set frequency at
1000 days.)
Press Frequency to proceed to the
touchscreen keypad.
Frequency To set the Frequency enter the number of days

1000
or tests. Press X to reselect or to confirm
1 2 3 4 5 6 7 8 9 0
and continue.
/ : ; ( ) $ & @ “
# + = . , ? ! ‘ delete
ABC Space

QC Lockout - ID NOW Assay 1 The screen will indicate selected Units and
Frequency. Press Cancel to return to previous
Warn Lockout Off screen. When parameters are set as desired,
press OK to confirm and continue.
Units Days
Frequency 100
Cancel OK
QC Lockout The QC Lockout screen will provide a summary

ID NOW Assay 1 Warn - 100 Tests
for each assay enabled on the instrument.
ID NOW Assay 2 Lockout - 30 Days
ID NOW Assay 3 Off
When the QC Lockout function is enabled (warn or lockout) the user will
be prompted to run QC negative and positive controls before a patient test
can be run. Alternatively, the user can change to a different lot (which has
had a valid QC negative and positive control associated with it.)
Run QC Test Both QC negative and QC positive tests must
Positive QC Test
generate valid results before the instrument
Negative QC Test
can run a patient test. Select Run QC Test and
follow the steps in Section 7.

4.15 Lot Management (Admin Access Only)
Home>Setup>Lot Management
This feature allows the Admin to review detailed Lot information.
Setup Select Lot Management to review QC test of
Connectivity
lots on instrument as well as to Export and/or
Import lots to and from instrument
QC Lockout
Lot Management
Reset to Factory Default
Lot Management Lot Management allows Admin to:

View All Lots • View All Lots on the instrument
Search Lots • Search for specific lots using assay,
Import QC Results date range, or status
Export QC Results • Import QC Results onto the instrument
from USB Drive
• Export QC Results on instrument to USB
Lot List
Drive
0123456 ID NOW Assay 1
Select View All lots to view a list of all lots
currently on the instrument. The Lot Status and
Assay will be visible.
Pos and Neg QC results passed
Incomplete Pos or Neg QC results
Pos or Neg or both QC results failed
Lots will be listed chronologically from newest
qualification to oldest.
Select Search Lots to search for a specific Lot
or all Lots run for a specific assay.
Lot - 0123456 Select a lot to see its details. In this example,
the Assay name as well as the Date and Time
Test Type: Influenza A & B
of its QC runs will be displayed. The Admin has
QC Neg DD/MMM/YYYY
the option to Lockout the chosen Lot here,
QC Pos DD/MMM/YYYY
regardless of current status. Press Cancel to
Lockout
return or OK to continue.
Cancel OK

Search Lots Enter Lot number or Assay name. Press OK to
continue.
Q W E R T Y U I O P
A S D F G H J K L
# Z X C V B N M delete
Cancel 123 Space OK
Export QC Results Chose Export QC Results to export all lots

on instrument.
Exporting lot QC Results
to USB device...
1. Enter USB drive
2. Select Export QC Results
This screen will appear to confirm export is in
process.
Export QC Results This screen confirms Export completed

successfully.
Exported 8 lot QC Results.
OK
Import QC Results Choose Import QC Results to import lots from

a USB drive that contains exported lot files.
Importing lot QC Results
to USB device...
1. Enter USB drive
2. Select Import QC Results
This screen will appear to confirm import is in
process.
Import QC Results This screen confirms Import completed

successfully.
Imported 12 lot QC Results.
Note: For any particular lot, information on
USB drive will replace information already
on the instrument.
OK

4.16 Reset To Factory Default (Admin Access Only)
Home>Setup>Reset to Factory Default
Setup Reset to Factory Default can be accessed
Time 1:13 pm
through the Setup screen and allows the Admin
to return the instrument to the default factory
Auto-logout 1 hour
settings.
Network 100.100.100.100
Remote Mode
Caution: This will delete all users, patient test results, and
QC results from the instrument. It is recommended that any
desired data be exported before performing this function.

5 Preferences Menu
Home>Preferences
Preferences Preferences allow the modification of the
Language English
instrument settings.
Sound Enabled Settings include:
Brightness 50% • Language
About • Sound
• Brightness
The About screen displays information about the instrument.

Chosen options are displayed to the right of each setting.
5.1 Language
Home>Preferences>Language
Language Warning Warning
English Active Change language? Language changed.

Reboot required.
Italiano XXXXXXX
Français
Deutsch
Cancel OK OK
Language allows the selection of a preferred language.

Select the desired language from the list. When prompted, press OK to
save the settings. The instrument will prompt to reboot the instrument for
languages to take immediate effect.
5.2 Sound
Home>Preferences>Sound
Sound The Instrument uses sound for the following
Keyboard Clicks On
functions:
Alerts On
• A click whenever the touch screen
is used.
• Tones will sound to indicate when the
Volume level: 80 instrument warm up routine is complete,
OK when the transfer cartridge is recognized,
and when the test is complete, as well as
for alerts and warnings.
Keyboard clicks and alert sounds can be turned on or off by using the
touch screen. Volume can be increased or decreased using the up and
down arrows.
Press OK to save the settings and return to the Preferences Menu.

5.3 Brightness
Home>Preferences>Brightness
Brightness The screen brightness may be adjusted using
the up and down arrows. The default and
Brightness
recommended setting is 50%.
Brightness Level: 30% Press OK to save the settings and return to the
Preferences Menu.
OK
5.4 About
Home>Preferences>About
About this Device Information about the instrument is
displayed here.
ID NOW Press Info to display further instrument
Serial No. BB8F3616 information.
Software © 2013-2018 Axxin, used under license.
All trademarks referenced are trademarks of either the
Abbott group of companies or their respective owners.
Back Info
5.5 Instrument Information

Home>Preferences>About>Info
About this Device The Info screen displays the following
Serial No: BB8F3616 information:
Baseboard Ver: 3 Core Ver: 4
FAM-3.0.8 ROX-3.0.8 Tray-4.1.0 Baseboard-2.00
Application Ver: 5.0.2
• Instrument Serial Number
IP Address: 172.16.0.16
MAC Address: 00:04:A3:E5:AB:F9 • Baseboard Version
Rev ID: d74c027fea3f
Update Number: 0553
Configuration: C.1.0.0
RAM: 255068 KB • Coreboard Version
Back
• Firmware Versions
• Application Version
• IP Address
• MAC Address
• Revision ID
• Software Update Number
• Total Memory (RAM)
• Assay Configuration

6 Running A Test
If the instrument is being used for the first time, it must be set up by the
Admin before a test can be run. For further details refer to Section 3 for
Admin setup.
• Refer to Section 4.2 to add Users.
• Refer to Section 5.1 to select language preferences.
6.1 User Login

Enter User ID or Scan When the instrument is switched on, or after
another User has logged out, the Enter User ID
Q W E R T Y U I O P
or Scan screen will be displayed.
A S D F G H J K L Enter the User ID, or scan using an electronic
# Z X C V B N M barcode reader, press to advance.
123
If a password is required (as specified by the
Enter Password
Admin during Setup), a prompt will appear to
enter the password. Press to advance.
Q W E R T Y U I O P
A S D F G H J K L
# Z X C V B N M
123
The instrument will automatically perform a Self Test.
Self Test:
Self Test The instrument will run a Self Test before
Running self test,
proceeding to the Home screen.
please wait ...
Self Test If the instrument lid is open, the instrument will

Close lid to
prompt to close the lid before running the Self
proceed. Test. The Self Test will not proceed until the lid
is closed.

6.2 Main Menu
Home
User ID
30/Jan/2018
10:12am
Once Self Test is complete, the Home screen
is displayed.
Run Run QC Review
Test Test Memory
6.3 First Time Use

Run QC Test When an assay or the instrument is used for
Positive QC Test
the first time the user is required to QC the
Negative QC Test
instrument by running both a QC negative and
QC positive external control before patient
testing is allowed.
Both QC negative and QC positive tests must generate valid results before
the instrument can run a patient test. Select Run QC Test and follow the
steps in Section 7.
6.4 Running A Test

From the Home screen, select Run Test.
Home 30/Jan/2018
User ID 10:12am
Run Run QC Review

Test Test Memory
Run Test Select the desired test from the list of assays
ID NOW Assay
available. Refer to Running a Test in the assay
specific ID NOW product insert for further
details.

Run Test Select your sample type.
Please Select Sample Type If the assay chosen has multiple sample types
to choose from, the user will be prompted to
Sample type 1 select their sample type.
Sample type 2
Enter or Scan Patient ID Enter Patient ID using on screen keyboard or

barcode scanner.
Q W E R T Y U I O P The Patient ID must be a minimum of 2 and
A S D F G H J K L maximum of 20 characters, is case-sensitive,
# Z X C V B N M and must be alphanumeric.
123 If the ID has been entered manually, press
when complete.
If the ID has been scanned and the Patient
ID is valid, if the barcode scanner is set up
to automatically advance, the instrument will
automatically advance to the next screen.
If the barcode scanner is not set up to
automatically advance, press .
Confirm Patient ID.

Run Test Check that the Patient ID information is correct
Patient ID:
and press OK to confirm.
10AX425
If the Patient ID is not correct, press Cancel to
return to the Enter Patient ID screen.
Cancel OK
Caution: Confirmation is required as Patient ID is not editable

once testing has commenced.
It is essential that the on-screen prompts are followed throughout

the testing process. See specific test product inserts for further
information.

7 Running A QC Test
ID NOW test kits contain Positive and Negative External Controls. When
an assay or the instrument is used for the first time, or when the software
is upgraded, the User is required to run both a positive and a negative
successful QC test before patient testing is allowed. See specific test
product inserts for further information regarding QC test frequencies.
Further controls may be tested in order to conform with local, state and/or
federal regulations, accrediting groups, or the lab’s standard Quality Control
procedures.
Select Run QC Test on the Home screen.
7.1 Run QC Test

Select the QC test to be run
Run QC Test Select the desired assay from the list of

ID NOW Assay
available assays.
Run QC Test Select and confirm a Positive or Negative QC

Positive QC Test
test. Confirm the test type to match the QC
Negative QC Test
sample intended for testing by pressing OK
and follow the on screen prompts to complete
testing.
If the incorrect QC test has been selected,
press Cancel to return to the QC Test Menu
Run QC Test screen.
Confirm test:
ID NOW Assay Test
Positive QC Test
Cancel OK

Enter or Scan QC Sample ID Enter or Scan QC Sample ID. Press to
confirm.
Q W E R T Y U I O P The QC Sample ID entered will be displayed.
A S D F G H J K L Press OK to confirm or cancel to reenter.
# Z X C V B N M
If it is not desired to enter or scan in the QC
123 sample ID leave blank and press to continue.
The QC test is run in the same manner as a
Run Positive QC Test
patient test.
QC Sample ID:
10AX425
For QC test procedure refer to the specific
test product inserts for running a test.
Cancel OK
7.2 QC Test Results

Positive QC Test Results Negative QC Test Results
1/Jan/2013 11:22am 1/Jan/2013 11:22am
User ID: Abbottuser1 Procedural User ID: Abbottuser1 Procedural
QC Sample ID: ######## Control Valid QC Sample ID: ######## Control Valid
Flu A/B Positive QC Pass Flu A/B Negative QC Pass
New Test Print New Test Print
QC test results will be displayed on the screen upon test completion.

These examples show positive and negative QC results for an Influenza
A & B Test.
QC Test Results When LIS/POCT has been configured, the
1/Jan/2013 11:22am status of each result is displayed on the QC
User ID: Abbottuser1 Procedural
QC Sample ID: ########
Sent: DD/MMM/YYYY hh/mm am/pm
Control Valid Test Results screen:
Flu A/B Negative QC Pass • Not Sent
• Queued for sending (as Not Sent, but
New Test Actions Auto-Sending is enabled, which will
eventually send the record)
• Connecting…
• Sending…
• Failed to send
• Failed to send, retrying…
• Sent (followed by the send date and time)
If a test result fails to transmit correctly, the instrument will attempt to send
it again up to 5 additional times, with a 30 second wait between attempts.

8 Printing Test Results
To print results, attach the Alere™ Universal Printer to the ID NOW Instrument.
See Section 11, Accessories, for further details and ordering information.
A single report for a single test

Influenza A & B Test of interest may be printed at the
completion of a test or from the
Patient ID: abcd123 review memory screen
Date: 12/Jul/2014 (Home>Review Memory).
Time: 11:22 AM
Attach the Alere Universal Printer
Influenza A: Positive to the instrument. Select Print. The
Influenza B: Negative instrument will print a report on a
Procedural Control Valid tear-off sticker.
Lot number: 0708530 The ID NOW Instrument will set the

default printer to the “connected”
Test ID: 1ef614e5-2283-43 printer if only one Alere Universal
30-a109-7df6e533b9d9 Printer is connected. If more than one
printer is connected, the instrument
User ID: admin will set the "first printer" connected
Instrument serial number: BAAC7715 printer as default.
It is recommended that the ID NOW
ID NOW Instrument is used with only one
connected Alere Universal Printer.
Abbott also recommends that only the Alere Universal Printer be used with
the ID NOW Instrument.

9 Review Memory
The ID NOW Instrument’s memory screens enable a user to search through
the stored data.
Select Review Memory from the Home menu screen.
Home>Review Memory
Review Memory Navigate through the instrument memory by
Patient Test Results
viewing a list of Patient Tests or QC Tests.
QC Test Results
Search Results
Export Results
Review Memory Patient and QC Test Results are exported in

Export Logfile
JSON format. A Logfile that records all the
Transmission Status
Pending instrument actions can also be exported.
nnn Unsent
The Status selection is accessible to all users

from this screen.
9.1 Patient Test Results

Home>Review Memory>Patient Test Results
Patient Test Results Select to choose what subset of test results
All
to view. Selecting "All" will display all of the
Influenza A & B
Patient Test Results on the instrument, whereas
choosing a specific assay will display only
Strep A
Patient Test Results that match that assay type.
Back
Patient Test Results 10 of 999

A list of all stored Patient Test Results will be
10AX4257 Strep A displayed, showing the first 8 characters of
14/NOV/2012 11:22 am
10AX8695 Influenza A & B the Patient ID. Use the up and down arrows to
13/NOV/2012 6:23 pm
Influenza A & B scroll through the list, and the touch screen to
10A45H56 14/NOV/2012 10:13 am
Strep A select and view a particular result.
WWWWWWWW 13/NOV/2012 11:22 am
Caution: Saved data should be archived regularly to prevent

loss. See Section 9.4, Export Results.

Test Results 10 of 999
Example of a Test Result, viewed in the
DD/MMM/YYYY 11:22am instrument memory.
Patient ID: 10AX425 Procedural
User ID: Abbottuser1 Control Valid
Flu A: Negative
Flu B: Positive
Back Print
Test Results When LIS/POCT has been configured, the

1/Jan/2015
Patient ID: 10AX425
11:22am connectivity status of each result is displayed
Procedural
User ID: Abbottuser1
Control Valid
on the Test Results screen:
Flu A: Negative
• Not Sent
Flu B: Positive
• Queued for sending (as Not Sent, but
New Test Actions Auto-Sending is enabled, which will
eventually send the record)
• Connecting…
• Sending…
• Failed to send
• Failed to send, retrying…
• Sent (followed by the send date and time)
If a test result fails to transmit correctly, the instrument will attempt to send
it again up to 5 additional times, with a 30 second wait between attempts.
9.1.1 Actions Key

Test Results When LIS/POCT has been configured, instead
Print
of Print, the Actions key is displayed.
Send Result This opens the Test Actions menu, which
contains Print (as before) and Send Result.
Send Result will send only the selected result.
Cancel It may also be used to send a result that was
QC Test Results previously sent.
Print
Send Result
Cancel

9.2 QC Test Results
Home>Review Memory>QC Test Results
QC Test Results Select to choose what subset of test results
All
to view. Selecting "All" will display all of the
Influenza A & B
QC Test Results on the instrument, whereas
choosing a specific assay will display only
Strep A
QC Test Results that match that assay type.
Back
QC Test Results 10 of 99
A list of all stored QC Test Results will be
Negative Strep A displayed, showing the date and time the test
14/NOV/2012 11:22 am
Negative Influenza A & B was run. Use the up and down arrows to scroll
13/NOV/2012 6:23 pm
Influenza A & B through the list, and the touch screen to select
Positive 14/NOV/2012 10:13 am
Strep A and view a particular result
Positive 13/NOV/2012 11:22 am
Negative QC Test Results 10 of 999 QC Test Results Examples of

01/Jan/2013 04:32 pm 1/Jan/2013 11:22 am QC Test Results,
User ID: Abbottuser1 Procedural User ID: Abbottuser1 Procedural
QC Sample ID: ######## Control Valid QC Sample ID: #######
Control Valid viewed in the
Flu A/B Negative QC Pass Flu A/B Negative QC Pass
instrument memory.
Back Print New Test Actions
9.3 Search Results

Home>Review Memory>Search Results
Search Results Use the Search Results function to search for
particular Patient Test Results.
Q W E R T Y U I O P The instrument will search Patient IDs and
A S D F G H J K L Date/Times, based on the text entered.
# Z X C V B N M
123
Patient Test Results 10 of 999

For example: Searching for the text “Jan”
10AX4257 Strep A will return any test results where the Patient
14/NOV/2012 11:22 am
10AX8695 Influenza A & B ID contains the text “Jan”, and also any test
13/NOV/2012 6:23 pm
Influenza A & B results that were obtained during the month
10A45H56 14/NOV/2012 10:13 am
Strep A of January.
WWWWWWWW 13/NOV/2012 11:22 am
A list of results matching the search criteria will be displayed and results
may be selected and viewed.
9.4 Export Results
Home>Review Memory>Export Results
Export Results To export results, for example when the
Exporting results to USB
instrument memory is full, a USB drive must be
device ... inserted into one of the instrument USB ports.
Individual test results are exported in JSON
format. A summary of all test results on the
instrument will be in CSV format.
Export Results After successfully exporting the results, the

Results successfully exported
instrument will give the option to delete all
to USB device. results stored in the instrument.
Delete local results?
Cancel OK
Caution: The ID NOW Instrument holds up to 999 patient

results and up to 99 QC test results. A warning will appear
prior to a full memory. Test and QC results must be exported before
the memory is full, or memory will be overwritten.
Export Results Archive saved data regularly to prevent loss.

Local results deleted.
OK

9.5 Export Logfile
Home>Review Memory>Export Logfile
Export Logfile If there is an issue using the instrument, Abbott
Exporting logfile to USB
Technical Support may request to export a
device ... Logfile and email it to them. Abbott Technical
Support will use the information in the log file
to assist with diagnosis of the issue.
Export Logfile To export Logfile, a USB drive must be inserted

Logfile exported.
into one of the instrument USB ports. Logfiles
are not readable by users. Send log files
to Abbott Technical Support to assist with
instrument diagnosis.
OK
Press OK to return to the Review Memory screen.

10 Software Updates
USB Software Update:
Caution: Stored test data and users may be deleted during the
software update process. Test results and users stored on the
ID NOW Instrument must be exported to an external formatted, USB Flash
Memory Drive prior to performing a software update. Users may be
reimported after the update.
Caution: DO NOT REMOVE USB DRIVE DURING SOFTWARE

UPDATE. USB Flash Memory Drive can be removed from the
ID NOW Instrument as per the software update sequence detailed below.
Update Sequence:
Step 1: Prior to software update, export test results and users stored on the
instrument.
Step 2: Turn the instrument off by pressing and holding the power button for
3 seconds or longer.
Step 3: Attach USB Flash Memory Drive with the required software update
(provided by Abbott) to the instrument via the USB port located on
the side of the instrument.
Step 4: Power up the ID NOW Instrument by pressing and holding the

power button. The instrument will automatically display the start-up
status bar. Follow the on-screen instructions to initiate the software
update.
Step 5: Press OK to install the configuration file. Warning

This step is necessary to enable any new Install configuration file?
Assay Types.
Press OK to install.
This will clear all Assay QC
Statuses.
Cancel OK
Step 6: When complete, the instrument will advance to the Login screen.
(Note: Due to a firmware update, the instrument may reboot on its
own. Repeat Step 5 if this occurs.)

Step 7: Remove the USB drive. Turn the instrument off by removing the
power cable from the instrument. (Do not use the power button
to power off the instrument.) Wait 10 seconds and then reattach the
power cable to the instrument. Power up the ID NOW Instrument by
pressing and holding the power button. The instrument will power
up as normal.
Prior to running an assay with the new software for the first time, the user
is required to run a positive and negative successful QC test before patient
testing is allowed. See Section 6.
If expected QC results are not obtained or you are unable to complete the
software update, please contact Abbott Technical Support.
Note: Only one USB drive may be present during the software update
process.

11 Accessories
Accessories for use with ID NOW Instrument are available separately:
• Alere Universal Printer
• Barcode Scanner
• ID NOW USB Drive
11.1 Alere™ Universal Printer

Order Number: 55115
Replacement Sticker Roll: 26333
Data Cable: EQ005002
Refer to Alere Universal Printer User Manual for more information. Abbott
recommends using the Alere Universal Printer with the ID NOW Instrument.
11.2 Barcode Scanner

Order Number: OPR2001ZWU1-201
Refer to the Barcode Scanner User Manual for more information. Only use
the Barcode Scanner provided by Abbott with the ID NOW Instrument.
11.3 ID NOW USB Drive

Order Number: EQ004001
Abbott recommends using the ID NOW USB Drive with the ID NOW Instrument.
Alternatively, other commercially available USB Flash Memory Drives can be

used. The USB must meet the following requirements:
• Formatted for FAT32, min 512 MB with only 1 partition.
• The USB Flash Memory Drive does not perform CD-ROM emulation.
• The USB Flash Memory Drive does not require proprietary software
loaded to run it.

12 Errors and Warnings
This section provides troubleshooting steps for specific error and warning
codes. Once the steps listed below are executed, if the error or warning
persists, contact Abbott Technical Support. Contact numbers can be found
at the end of the User Manual.
12.1 Errors
[Note: These are arranged in order of the time they may appear in
the process]
12.1.1 Power On & Loading Error

Error: Please Set Clock
Error If the internal battery fails, the instrument will
lose the time and date.
Please Set Clock
There has been a clock Action: The Admin must log in and reset the
error. Please refer to user
manual.
date and time:
Home>Setup>Date; Home>Setup>Time.
OK
If this error occurs in a subsequent power up of the instrument, there may

be an on-going time and date fault.
12.1.2 Initial Admin Setup Error

Error: Invalid Password
Error Passwords must be 2 to 20 characters long,
are case-sensitive, and must be alphanumeric.
Invalid Password
Must be 2 to 20 characters.
The password cannot contain spaces.
Action: Choose a password that meets the
above criteria.
OK

12.1.3 User Login Errors
Error: User ID Not Recognized
Error The instrument does not recognize the User ID
entered.
User ID Not Recognized
Please try again. Action: Press OK to try again. If the error
persists, the Admin must log in to check that
the User ID has not been deleted. If it has, or if
OK this is a new User, the Admin must set up the
User ID:
Home>Setup>Users or
Home>Setup>Users>New User.
User IDs are not case sensitive.
Error: Password Not Recognized

Error The instrument does not recognize the
password entered.
Password Not Recognized
Please try again. Action: Press OK to try again. If the error
persists, the Admin can log in to check or
change the password: Home>Setup>Users.
OK
Note: Passwords must be 2 to 20 characters long, are case-sensitive, and

must be alphanumeric. The password cannot contain spaces.
Error: Firmware Communications Error

Error The instrument cannot conduct its Self Test.
Firmware Communications Error Action: Press OK to try again. If the error
Self Test cannot be conducted. persists, reboot the instrument by turning it off
Please refer to user manual.
Press OK to repeat test.
and on again.
If this error persists, tests cannot be run on
OK the instrument. However, stored data can be
viewed: Home>Review Memory.

Error: Rotor Hardware Fault
Error The instrument has failed its Self Test due to a
rotor fault.
Rotor Hardware Error
Self Test cannot be conducted. Action: Open the lid and ensure there are no
consumable parts or other items blocking
movements of the test rotor.
OK
If no obstruction is found and error persists, discontinue using the

instrument and contact Technical Services.
Error: Reading Error – Empty Well

Error The instrument has failed the Self Test due to
the empty wells having a high fluorescence
Reading Error - Empty Well
Self Test cannot be conducted.
reading.
Action: Ensure that the Test Base is not in the
Test Base holder, and press OK to try again.
OK If the Test Base is not present, clean the Test
Base well using a swab and ethanol and press
OK to try again.
If this error persists, tests cannot be run on the instrument. However,
stored data can be viewed: Home>Review Memory.

Error: Reading Error – High Side
Error The instrument cannot conduct its Self Test.
The instrument has failed its Self Test due to a
Reading Error - High Side
target in the instrument not providing sufficient
Please refer to user manual. response.
Action: Press OK to try again, press Home to
OK return to the Home menu. Without successfully
completing Self Test the user can review
results and instrument details but cannot run
a test.
Error: Discard Pieces for Self Test

Error The instrument cannot conduct its Self Test if
parts of the test are inside the instrument.
Discard Pieces for Self Test
Attach test base/transfer Action: Remove test pieces as shown under
cartridge onto sample receiver
and discard.
Running a Test, and press OK to try again.
OK
If this error persists or if there are no test pieces in the instrument, check
that there is not a foreign object or contamination obscuring the detector
window in the bottom of the sample receiver heater block as this may be
registered by the instrument as a sample receiver consumable being in
place.
Press OK to try again, press Home to return to the Home menu. Without
successfully completing Self Test the user can review results and
instrument details but cannot run a test.

12.1.4 Home Errors
Error: QC Test Failed
Error The QC test failed for the selected assay and
must be repeated successfully before patient
QC Test Failed
Please run a new QC Test.
samples can be tested.
Action: Press OK to return to the Home screen
and run a QC test again (Home>Run QC Test).
OK

Error: The Last Self Test Failed

Error The instrument’s last Self Test failed.
The Last Self Test Failed Action: Press OK to return to the Home
Please logout and try again. screen. Log out (Home>Logout) and try
logging in again.
If this error persists, tests cannot be run on
OK the instrument. However, stored data can be
viewed: Home>Review Memory.
Error: Access Denied

Error Only the Admin can access these settings.
Access Denied Action: Press OK to return to the Home
Only the administrator can screen.
access these settings.
Contact the Admin to access these settings.
OK

12.1.5 Run Test / Run QC Test Errors
Error: Configuration Not Installed
Error A configuration file has not been installed on
the instrument.
No configuration file installed.
Testing is locked out.
Action: Press OK to return to the Home
screen. Contact Abbott Technical Services.
OK
Error: Invalid Patient ID

Error Patient ID must be 2 to 20 characters long, are
not case-sensitive, and must be alphanumeric.
Invalid Patient ID
The Patient ID must be between
The Patient ID cannot contain spaces.
2 and 20 characters.
Action: Press OK to try again. If the error
persists while using the barcode scanner, enter
OK the patient ID manually.
Error: Barcode Not Recognized

Error The instrument has not recognized the barcode
on the Test Base and cannot start the testing
Barcode Not Recognized
process.
Action: Press OK to try again. The instrument
will ask to remove the Test Base. The
OK instrument will then perform a Self Test. Once
complete, try again using the same Test Base.
Discard Pieces
If the error persists, dispose of the Test Base
Remove test base and try a new Test Base.
from device and
discard.
Note: The barcode on the Test Base must face the back of the instrument
to be recognized.

Error: Timeout
Error The instrument has timed out during any of the
steps in the testing process. More than the
Timeout
Your test has timed out.
defined amount of time elapsed during one of
Please discard all pieces and the steps outlined below.
run a new test.
For example:
OK 1. Between inserting the Test Base and
inserting the Sample Receiver.
Discard Pieces 2. Between the completion of the warm up and
Remove test base the addition and confirmation of the sample
from device and
discard. 3. Between adding the sample and transferring
it from the Sample Receiver to the Test Base.
4. Between transferring the sample and closing
the lid.
Action: Press OK. Remove and dispose of all test pieces and repeat with a
new test. Follow the on-screen instructions closely.
Error: Lid Open

Error The lid must not be opened during the testing
process.
Lid Open
Test Cancelled. Action: Press OK. Remove and dispose of all
test pieces and repeat with a new test.
OK
Error: Test Failed

Error The test has encountered an unrecoverable
error.
Test Failed
Please run a new test. Action: Press OK. Remove and dispose of all
test pieces and repeat with a new test.
OK

Error - Invalid Frequency
Error If the User enters a non-numeric or numerical
value greater than 1000, for the QC frequency,
Invalid Frequency
Entry must be numeric between
this Error will appear.
1 and 1000.
Action: Press OK and enter a numeric value
between 1 and 1000.
OK
Error: QC Incomplete
Error For assays configured with QC Lockout set
to Warn or Lockout, this Error will appear
QC Incomplete
Lot [####] has no valid QC Run when a new patient test is attempted with a
history. Please complete a QC Run
for Lot [####] or run the test with
lot that does not have a valid QC Positive and
a different lot of consumables. Negative result.
OK Action: Select OK to stop the patient test and
proceed to conduct a QC run for the lot OR the
user must use a different lot of consumables
for the run.
Invalid Test Results

Test Results If a test completes but the instrument failed
7/Feb/2013 11:22am to determine a result, the test will display an
Patient ID: 10AX425
Invalid message for that result and will archive
Flu A: Invalid it in the instrument memory.
Flu B: Invalid
This example shows an Influenza A & B Invalid
New Test Print test result. Refer to the relevant Package Insert
for further details.
Repeat the test using new test pieces. An invalid test may occur due to:
• Patient sample interference.
• Instrument malfunction.
• Malfunction of one or more of the test pieces.

12.1.6 Printing Result Error
Error: Printer Not Found
Error The instrument has not recognized the printer.
Printer Not Found Action: If printer is not connected, connect it.
Please check your printer If it is connected, check the printer connection.
connection.
Press OK to try again.
If this error persists, completely unplug the
OK printer, reconnect to the instrument and press
OK to try again.
Confirm the printer power supply is connected and the printer is turned
on. Confirm printer power LED is illuminated. Confirm USB data cable is
connected at the printer and the instrument.
If the problem persists, remove USB connector at the instrument,
wait 10 seconds, and reconnect.
Repower the instrument and try again. The test result can be printed from
the Review Memory screen.
12.1.7 Review Memory Errors

No Results Saved
Patient Test Results Under Patient Test Results, this screen will be
No results saved.
displayed if the instrument has not yet been
used for patient testing or following export and
deletion of all results.
OK
QC Test Results Under QC Test Results, this screen will be

No results saved.
displayed if the instrument has not yet been
used or following export and deletion of all
results.
Action: Press OK to return to the Home
OK screen.

12.1.7 Review Memory Errors
Error: Test Result Not Valid
Error The stored result has been corrupted and
cannot be viewed.
Test Result Not Valid
The selected test result has Action: Press OK to return to the list of test
become corrupted.
results.
OK
12.1.8 Search Results Error

No Results Found.
Search Results No results have been found matching the
No results found containing:
search criteria.
“AX10568”
Action: Press OK and try searching again
using new search criteria
OK
12.1.9 Export Results & Export Logfile Errors

Error: USB Drive Not Found
Error The instrument has not recognized the USB
drive.
USB Device Not Found
Please check your USB Device Action: If a USB drive is not connected,
connection.
connect it. If it is connected, check the
connection. If this error persists, try using a
OK different USB drive.
Press OK to return to the Review Memory
screen.
Error: Export Failed

Error The export was not successful.
Export Failed Action: Repeat the export process. If this error
Please try again. persists, try using a different USB drive.
Press OK to return to the Review Memory
screen.
OK

12.1.10 New User Errors
Error: Maximum Users Reached
Error A maximum of 999 users plus the Admin user
can be set up.
Maximum Users Reached
Please delete an existing user Action: Press OK to return to the User screen
before adding a new user.
to review the Users and delete Users no longer
needed. This will not affect saved data.
OK Note: The Admin cannot be deleted.
Error: Invalid User ID

Error The User ID is in an invalid format. It must be
2 to 20 characters and alphanumeric. User IDs
Invalid User ID
are not case sensitive.
Action: Press OK to try again. If the error
persists, enter the User ID manually.
OK
Error: User ID Already Exists

Error The User ID already exists.
User ID Already Exists Action: Press OK to try again. If this is a
Please use a different ID. different user, assign a unique User ID.
OK

Invalid Password
Action: Press OK to try again. Choose a
password that meets the above criteria.
OK

12.1.11 User Details Errors
Error: Password Not Recognized
password entered.
Password Not Recognized
Please try again. Action: Press OK to try again. Note that
passwords are case-sensitive. If error persists,
the Admin can log in to check or change the
OK password: Home>Setup>Users.

Invalid Password
above criteria.
OK

Error The instrument has not recognized the
USB drive.
USB Drive Not Found
Please check your USB connection. Action: If a USB drive is not connected,
connection.
OK If this error persists, use a different USB drive.
Error: Import Failed

Error The import was not successful.
Import Failed Action: Repeat the import process. If this error
Please try again. persists, ensure that the USB drive contains
the user list. If the error continues, try exporting
the user list again from the source ID NOW
OK Instrument, if available, and import again.
If error persists, export the list to a different USB drive and import again.

12.1.12 Import Users Errors
drive.
connection.
connection.
Error: Import Failed

Error The import was not successful.
Import Failed Action: Repeat the import process. If this error
Please try again. persists, ensure that the USB drive contains
the user list. If the error continues, try exporting
the user list again from the source ID NOW
OK Instrument, if available, and import again.
If error persists, export the list to a different USB drive and import again.
12.1.13 Export Users Errors

drive.
connection.
connect it now. If it is connected, check the
connection.
Error: Export Failed

Error The export was not successful.
Export Failed Action: Repeat the export process. If this
Please try again. error persists, ensure that the USB drive has
available memory.
If the error persists, use a different USB drive.
OK

12.1.14 Network Errors
Error: IP Address Invalid
IP Address entered.
IP Address Invalid
Please enter a valid IP Address. Action: Press OK to try again. The IP Address
must consist of four sets of numbers,
separated by “.” (i.e. 111.222.333.444).
OK
If this error persists, contact your Network Administrator or IT Help Desk

to ensure that the IP Address is correct. Press Cancel to return to the User
Settings screen or Home to return to the Home screen.
Error: Subnet Mask Invalid

Error The instrument does not recognize the Subnet
Mask entered.
Subnet Mask Invalid
Please enter a valid Subnet Action: Press OK to try again. The Subnet
Mask.
Mask must consist of four sets of numbers,
separated by “.” (i.e. 111.222.333.444).
OK
If this error persists, contact your Network Administrator or IT Help Desk to

ensure that the Subnet Mask is correct. Press Cancel to return to the User
Settings screen or Home to return to the Home screen.
Error: Network Error

Error The instrument encountered a network error
while trying to apply settings.
Network Error
Network settings not applied. Action: Select OK and the instrument will try
Press OK to refresh settings.
again.
Check the network connection, and apply the
OK changes again. If the error persists, reboot the
instrument by turning it off and then on again,
and attempt the changes again.

12.1.14 Network Errors
Error: Port Number Invalid
Error Valid ports are whole numbers between 1 and
65535, as configured and appropriate to the
Port Number Invalid
Please enter a valid Port
laboratory information system.
number
Action: Use a valid port number meeting the
criteria described above.
OK
12.1.15 Admin Password Errors

Error: User ID Not Recognized
Error The instrument does not recognize the Admin
ID entered.
User ID Not Recognized
Please try again. Action: Press OK to try again. Ensure that the
correct ID was entered. Admin ID: Admin.
OK

Invalid Password
above criteria.
OK
12.1.16 Miscellaneous Errors

Error: Critical Error
Error The software has encountered a critical error
and the application can only restart to recover.
Critical Error
Application has a critical error. Action: Press OK to reboot the instrument
Reboot required.
OK

12.1.16 Miscellaneous Errors
Error: Temperature Out of Range
Error The heater temperature is not at the required
temperature to perform a test.
Temperature Out Of Range
Test can not be conducted. Action: Make sure that the lid is closed
and wait 5 minutes for the heater to warm
the sample receiver and test base receiver.
OK Repeat the test. If the error persists, reboot the
instrument by turning it off and then on again.
Error: Reading Error – Low Side

Error The instrument has failed its Self Test due to a
target in the instrument not providing a correct
Reading Error - Low Side
response.
Action: Press OK to try again or press Home to
return to the Home menu. Without successfully
OK completing Self Test the user can review results
and instrument details but cannot run a test.
Error: Hardware Timeout

Error The instrument hardware encountered an
internal hardware response error.
Hardware Timeout
Test Cancelled. Please refer to Action: Repeat the test. If the error persists,
user manual. Reboot required.
reboot the instrument by turning it off and then
on again.
OK
Error: Installation Failed

Error There was an error during the installation of a
software update.
Configuration file cannot be
installed.
Action: Power off the instrument, insert the
USB containing the software update, power
the instrument back on.
OK If the issue persists, contact Abbott Technical
Services to obtain the latest version of
software.

12.2 Warnings
[Note: These are arranged in order of the time they may appear in the
process]
12.2.1 Home Warnings

Warning: Memory Almost Full
Warning The instrument can run only 50 more patient
tests or 9 more QC tests before the memory
Memory Almost Full
50 tests remain before
is full.
memory is full.
Action: Press OK to continue to run the current
test. With each additional test or QC test
OK carried out, a similar error will be displayed
showing the number of tests remaining. The
Admin must export the stored test results
before the memory is full, or results will be
overwritten. See Section 9.4, Export Results.
Warning: Memory Is Full

Warning The instrument can store up to 999 patient test
and 99 QC results, and is now full.
Memory Is Full
Please export results Action: To avoid overwriting stored data, the
otherwise tests will be over-
written.
Admin must export the data. See Section 9.4,
Export Results.
OK
Alternatively, Press OK to continue to run the current test.

Note that this will overwrite stored data.
Warning: Heater Not At Temperature

Warning The instrument has not yet reached the
required temperature.
Heater Not At Temperature
Please wait for heater to Action: Press OK to return to the Home screen
reach temperature.
and wait for the white light on the front of the
instrument to stop flashing before trying again.
OK
If the error persists, power off the instrument, disconnect the DC power
input connector, wait 10 seconds, reconnect and turn on the instrument.
When the white light on the front of the instrument stops flashing, try again.
If this error persists, tests cannot be run on the instrument. However, the
stored data can still be viewed: Home>Review Memory.

12.2.2 Run Test/Run QC Test Warnings
Warning: Incorrect Test Base
Warning A test base was inserted that does not match
the test type initially selected from the menu.
Incorrect Test Type
The Test Base inserted is Action: The test must be restarted. Remove
different from what was
selected.
the test base and close the lid to allow the
instrument to perform a self test. Restart the
OK test, as desired.
Discard Pieces
Remove test base

from device and
discard.
Warning: Stop Test

Warning The Home button was pressed during testing.
Testing cannot be stopped and then resumed
Stop Test
Do you want to stop this test?
after one or more test pieces have been placed
Results will be lost and pieces in the instrument.
cannot be reused.
Action: To continue testing, press Cancel. The
Cancel OK timeouts will continue counting even with this
screen displayed.
Discard Pieces
To cancel the test, press OK. Remove and
Remove test base dispose of all test pieces.
from device and
discard.
Warning: QC Frequency Exceeded

Warning If a frequency is set under warn within the QC
Lockout function, when the assay Frequency
QC Frequency Exceeded
Assay [####] has exceeded its expires and a user attempts to conduct
use Frequency. Would you like
to proceed without conducting
a patient test for that assay; this warning
a QC Run for Assay [####]? message will appear.
Cancel OK Action: Select OK to proceed with the run
or select Cancel to stop the patient test and
proceed to conduct a QC run for the assay.
12.2.2 Run Test/Run QC Test Warnings
Warning: QC Frequency Low
Warning For all assays; this warning message will
appear when the testing interval has been
QC Frequency Low
Assay [####] has [n] days/tests configured and the number of days remaining
before it will require a new QC has either reached 3 (unit set to days) or when
Run.
number of tests remaining is at 10%.
Action: Select OK to proceed with the run or
Cancel OK
select Cancel to stop the current patient test
and proceed to conduct a QC run for the assay.
Warning: Assay Locked Out

Warning If a frequency is set under lockout within
the QC Lockout function, when the assay
Assay Locked Out
Assay [####] is not valid for use at Frequency expires and a user attempts to
this time. Please conduct a QC Run conduct a patient test for that assay; this
for Assay [####].
warning message will appear.
Action: Proceed to conduct a QC run for the
OK
assay before a patient test can be run.
12.2.3 Setup Warnings

Warning: Time Updated
Warning If POCT DMS updates the date/time while
not on the Home screen, this message will
Time Updated
The system date/time has been
be visible the first time User returns to Home
updated by remote screen. Press OK to continue.
connectivity.
OK
Warning: Reboot Required

Warning This Warning will display in the Connectivity
sub-menu when switching between LIS and
Reboot Required
The connectivity type has
POCT Connectivity protocol types.
changed. Please reboot for
changes to take effect.

12.2.3 Setup Warnings
Warning: Reset Factory Default
Warning If the instrument is reset to factory default
settings, all Users, patient and QC results,
Reset Factory Default
Are you sure you want to
preferences and chosen settings, including
reset your device to factory language, will be lost.
default settings?
The instrument will start up as it did when first
Cancel OK received from the manufacturer, and can be
reconfigured by the Admin.
Abbott suggests exporting all user, patient and QC results to a USB drive
prior to resetting to factory default.
Press Cancel to return to the Setup menu. Press OK to reset to factory
default.
12.2.4 User Warnings

Warning: Delete User
Warning If a User is deleted, all data associated with the
User will be lost. However, stored data files will
Delete User
Are you sure you want to delete
not be affected.
user:
“James”
Action: Press OK to permanently delete the
user. Press Cancel to return to the Setup Users
Cancel OK screen
Warning: User List Updated

Warning After a User credential update by POCT DMS,
this message will be visible the first time User
User List Updated
The system user list has been
returns to Home screen. Press OK to continue.
updated by remote
connectivity.
OK

13 Symbols
USB 2.0 High Speed interface connector
Wired Ethernet, 10/100 Mb/s connector
DC Power connector, for connection with

12V DC
supplied external. Power Supply and Adaptor.
12VDC, 3.0 Amp maximum
Hot Surface
Biological Hazard
Caution, consult accompanying documents
Restriction of Hazardous Substances

Compliant
Waste Electrical and Electronic Equipment

Directive Compliant
Serial Number
In Vitro Diagnostics
EC REP

CE Mark
Manufacturer
On-Off Power Button
This device complies with part 15 of the FCC Rules. Operation is subject
to the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.

14 Ordering and Contact Information
Reorder numbers:
#NAT-000: ID NOW Instrument
OUS +1 321 441 7200
Technical Support
Advice Line
Further information can be obtained from your distributor, or by contacting
Technical Support on:
USA
+1 855 731 2288 [email protected]
Africa, Russia, CIS

Asia Pacific
Canada
Europe & Middle East

Latin America
+57 2 6618797 [email protected]

15 Warranty
Warranty (EN)
Limited 2 Year Warranty
Use of the ID NOW Instrument
The ID NOW Instrument is a fluorescence-based instrument for the

processing and analysis of ID NOW tests utilizing isothermal nucleic acid
amplification technology for the qualitative detection of infectious diseases.
Proper adherence to the instructions in the User Manual and package insert
are critical to proper operation.
WARNING: Failure to comply with the User Manual could lead to

inaccurate results.
Limited Warranty
Manufacturer guarantees to the original purchaser of the Instrument that
the Instrument is free from material defects for two years from the date of
purchase. This warranty does not guarantee the uninterrupted operation
of the Instrument. Manufacturer's only liability and Purchaser's exclusive
remedy under this warranty is that during the warranty period Manufacturer
shall replace or repair, at no charge, and at the Manufacturer's sole
discretion, any Instrument with a defective component. MANUFACTURER
MAKES NO OTHER WARRANTIES AND EXPRESSLY EXCLUDES ANY
IMPLIED WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT OR
FITNESS FOR A PARTICULAR USE.
There are no user-serviceable parts in the Instrument. Tampering with any

portion of the Instrument, abusing the Instrument or using the Instrument
in a manner inconsistent with its User Manual will void this warranty. This
warranty does not apply to any component that is damaged by improper
storage in environmental conditions outside the recommended range,
accident, or that is subject to alteration, misuse, tampering or abuse.
Purchaser must file a warranty claim in writing and within the applicable
warranty period to the Manufacturer.
Please contact Technical Support prior to returning any defective

components. Refer to Ordering and Contact Information section of the User
Manual for additional information.

MANUFACTURER'S ENTIRE LIABILITY IN CONNECTION WITH THE
INSTRUMENT, REGARDLESS OF THE LEGAL OR EQUITABLE BASIS OF
ANY CLAIM, IS LIMITED TO THE PURCHASE PRICE OF THE INSTRUMENT.
IN NO EVENT WILL MANUFACTURER BE LIABLE FOR ANY INCIDENTAL,
INDIRECT, SPECIAL, CONSEQUENTIAL, OR PUNITIVE LOSS OR
DAMAGES IN ANY WAY RELATED TO THE INSTRUMENT, OR ANY THIRD
PARTY CLAIMS, EVEN IF MANUFACTURER OR ITS DISTRIBUTORS ARE
AWARE OF THE POSSIBILITY OF SUCH CLAIM OR DAMAGES AND
NOTWITHSTANDING THE ESSENTIAL PURPOSE OF ANY REMEDY.

Alere Scarborough, Inc.
10 Southgate Road
Scarborough, Maine 04074 USA
www.alere.com
© 2018 Abbott. All rights reserved. All trademarks referenced are trademarks

of either the Abbott group of companies or their respective owners.
Software © 2018 Axxin, used under license.

All trademarks referenced are trademarks of their respective owners.
INNAT000 Rev. 9 2018/08

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ID NOW

Instrument User Manual

ID NOW Instrument User Manual

USB with Power on

ID NOW Instrument User Manual

Run Run QC Review

Preferences Setup Log Out

Run Run Review Preferences Setup Logout

QC Test Sound User

Search Brightness Assay Import

ID NOW Instrument User Manual

2 ID NOW Instrument At A Glance............................ 10

8 Printing Test Results............................................... 38

2 ID NOW Instrument User Manual

12 Errors and Warnings............................................... 47

ID NOW Instrument User Manual 3

 aution: Hot Surfaces. The Sample Receiver holder in this instrument

Caution: Never move the instrument while a test is in progress.

 aution: Follow proper infection control guidelines for handling all

 aution: Risk of electrical shock. Do not operate the instrument or the

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

4 ID NOW Instrument User Manual

 aution: USB and Ethernet Interfaces. If intended for connection to

 aution: If any assay components are dropped, cracked, found to be

 aution: To avoid contamination, do not move the ID NOW Instrument

ID NOW Instrument User Manual 5

This document describes the setup, configuration and operation of the

1.2 Product Description

6 ID NOW Instrument User Manual

10/100 Mbps Ethernet Port for Data Transfer

15ºC to 30ºC (50ºF to 86ºF)

ID NOW Instrument User Manual 7

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

1.5 Instrument Calibration

However, if the instrument was transported or moved, a performance check

8 ID NOW Instrument User Manual

Do not disassemble the instrument for cleaning.

Do not immerse in water or cleaning solutions.

Do not clean with soap or other solutions.

• Power Supply and Adaptor

ID NOW Instrument User Manual 9

LED Status Indicator

10 ID NOW Instrument User Manual

USB Connection Carrying Handle

ID NOW Instrument User Manual 11

3.1 Initial Setup

Power Up: Once the power is connected,

3.2 Instrument Status Light

Slow flash Starting up/ heaters not at temperature

On solid Heaters at temperature

Fast flash Hardware fault or shutting down

3.3 User Interface

12 ID NOW Instrument User Manual

3.6 Onscreen Keyboard

aution: Hot Surfaces. The Sample Receiver holder in this instrument

Caution: Never move the instrument while a test is in progress.

aution: Follow proper infection control guidelines for handling all

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

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

aution: USB and Ethernet Interfaces. If intended for connection to

aution: If any assay components are dropped, cracked, found to be

aution: To avoid contamination, do not move the ID NOW Instrument