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Abbott ID NOW NAT-024 Instrument User Manual

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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
• IDNOW Instrument User Manual
• IDNOW 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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