User Manual
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ID NOW INSTRUMENT USER MANUAL ™
NAT-000
INITIAL ADMIN SETUP
Power on & loading
USB with Software Update
Software Update
Initial Admin Setup
User Login
Home
ID NOW Instrument User Manual
Admin password reset
Clock reset
HOME SCREEN MENUS Home
30/Jan/2018 10:12am
User ID
Run Test
Run QC Test
Review Memory
Preferences
Setup
Log Out
Home
Run Test
Run QC Test
Review Memory
Preferences
Setup
Patient Test Results
Language
Login
New User
QC Test Results
Sound
Users
User Name
Search Results
Brightness
Assay Preference
Import Users
Export Results
About
Patient Details
Export Users
Date
Early Detection, on/off
Export Logfile
Transmission Status
Logout
Time
AutoLogout
Network
Setup
Remote Mode
Status
Connectivity
AutoSending
QC Lockout
Lot Management
Auto Print
Reset to Factory Default
*The Connectivity Status options will only appear when the instrument has been configured by the Admin to specify the port and address of the ASTM LIS, HL7, or POCT server. ID NOW Instrument User Manual
CONTENTS Warnings and Safe Use... 4 1
Introduction... 6
1.1 1.2 1.3
Intended Use...6 Product Description...6 Instrument Specifications ...7 1.3.1 Instrument ...7 1.3.2 12V Power Supply...8 1.4 Unpacking... 8 1.5 Instrument Calibration... 8 1.6 Maintenance & Cleaning...9 1.7 Components...9
2
ID NOW Instrument at a Glance...10
3
Getting Started - Setup... 12
4
™
3.1 3.2 3.3 3.4 3.5 3.6 3.7
Initial Setup... 12 Instrument Status Light ... 12 User Interface... 12 Home Screen... 13 Navigation... 13 Onscreen Keyboard... 13 Admin Setup...14
Setup Menu... 17
4.1 Log In (Admin Access Only)... 17 4.2 Users... 18 4.3 Assay Preferences (Admin Access Only)...20 4.3.1 Sample Type Selection (Admin Access Only)...21 4.3.2 Early Detection (Admin Access Only)...21 4.4 Patient Details (Admin Access Only)... 22 4.5 Date (Admin Access Only)... 22 4.6 Time (Admin Access Only)... 22 4.7 Auto Logout (Admin Access Only)... 23 4.8 Network (Admin Access Only)... 23 4.9 Remote Mode (Admin Access Only)... 24
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4.10 Connectivity (Admin Access Only)... 24 4.11 Connectivity Setup Screen (Admin Access Only)... 25 4.11.1 IP Address (Admin Access Only)...25 4.11.2 Port Number (Admin Access Only)...25 4.11.3 Clear Settings (Admin Access Only)...25 4.12 Status Screen... 26 4.13 Auto-Sending Screen (Admin Access Only)... 26 4.14 Clear Sent History (Admin Access Only)... 26 4.15 QC Lockout (Admin Access Only or via POCT server) ... 26 4.16 Lot Management (Admin Access Only or via POCT server) ... 29 4.17 Auto Print (Admin Access Only) ... 31 4.18 Reset To Factory Default (Admin Access Only)... 31
5
6
7
Preferences Menu... 32
5.1 5.2 5.3 5.4 5.5
Language... 32 Sound... 32 Brightness... 33 About ... 33 Instrument Information... 33
Running a Test... 34
6.1 6.2 6.3 6.4
User Login... 34 Main Menu... 35 First Time Use... 35 Running A Test... 35
Running a QC test... 37
7.1 7.2
Run QC Test...37 QC Test Results... 38
8
Printing Test Results... 39
9
Review Memory...40
9.1
Patient Test Results...40 9.1.1 Actions Key...42 9.2 QC Test Results... 42 9.3 Search Results... 43 9.4 Export Results... 43 9.5 Export Logfile...44 2 ID NOW Instrument User Manual
10 Software Updates...45 11 Accessories... 47 11.1 Universal Printer... 47 11.2 Barcode Scanner... 47 11.3 ID NOW™ USB Drive... 47
12 Errors and Warnings...48
12.1 Errors...48 12.1.1 Power On & Loading Error...48 12.1.2 Initial Admin Setup Error...48 12.1.3 User Login Errors...49 12.1.4 Home Errors...51 12.1.5 Run Test / Run QC Test Errors...51 12.1.6 Printing Result Error...53 12.1.7 Review Memory Error...53 12.1.8 Search Results Error...54 12.1.9 Export Results & Export Logfile Errors...54 12.1.10 New User Errors...54 12.1.11 User Details Errors...55 12.1.12 Import Users Errors...56 12.1.13 Export Users Errors...56 12.1.14 Network Errors...56 12.1.15 Admin Password Errors...57 12.1.16 Miscellaneous Errors...58 12.2 Warnings... 59 12.2.1 Home Warnings...59 12.2.2 Run Test/Run QC Test Warnings...60 12.2.3 Setup Warnings...61 12.2.4 User Warnings...61
13 Symbols... 62 14 Ordering and Contact Information...64 15 Warranty... 65
ID NOW Instrument User Manual 3
WARNINGS and SAFE USE The following warnings are to be used as an aide in risk mitigation. aution: Use only the power supply that is provided with the instrument. Use C the appropriate power supply for the region. The correct power supply is required to maintain the safety and electromagnetic compatibility of the system. aution: The power supply that is provided should only be used with the C ID NOW Instrument. aution: Hot Surfaces. The Sample Receiver holder in this instrument operates C at up to 60ºC (140ºF) and may cause contact burns or damage to materials in contact with this area. aution: Always operate this instrument on a clean, flat, level and stable surface C not in direct sunlight. Do not drop the instrument. Ensure that air flow to the ventilation openings located on the back and base of the instrument are not restricted. Caution: Never move the instrument while a test is in progress. aution: Follow proper infection control guidelines for handling all specimens C and related items. Properly dispose of all contaminated waste according to federal, state, and local requirements. aution: Risk of electrical shock. Do not operate the instrument or the power C supply if it has been opened, damaged or exposed to moisture, condensation or rain. aution: Do not disassemble or attempt to repair the ID NOW Instrument C or other accessories as there is a risk of damage to the instrument. This instrument does not contain serviceable parts and should be returned for repair. Disassembling the instrument will also void the warranty. aution: Only operate the instrument for its intended purpose and in C accordance with this user manual and warnings. If the instrument is used in a manner not specified in the user manual, protection provided by the equipment will be impaired. This instrument (including power supply) is designed to operate within the manufacturer’s specifications. Do not exceed the manufacturer specifications when in use.
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aution: Position the unit with clear access to connectors. Keep connected C cables clear of work areas such that tripping or catching will not pull the unit off its work bench. The mains socket outlet intended for use with ID NOW power supply should be located near the instrument and be readily accessible. Abbott recommends that cables are disconnected when not in use for an extended period. aution: USB and Ethernet Interfaces. If intended for connection to external C equipment, please ensure that interfaces of such equipment are separated from mains by double or reinforced insulation and present no risk of electrical shock. aution: If any assay components are dropped, cracked, found to be damaged or C open when received, DO NOT USE and discard. aution: Due to the high sensitivity of the assays run on the instrument, C contamination of the work area with previous positive samples may cause false positive results. Handle samples according to standard laboratory practices. Clean instruments and surrounding surfaces according to instructions provided in Section 1.6, Maintenance & Cleaning. aution: Once reacted, the Test Base contains large amounts of amplified C sample (Amplicon). Do not disassemble the Test Base and Transfer Cartridge. In the case of a positive sample this could lead to amplicon leakage and potential false positive ID NOW test results. aution: To avoid contamination, do not move the ID NOW Instrument during a C run or until all assay components have been removed from the instrument.
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1
INTRODUCTION
1.1
Intended Use
The ID NOW™ Instrument is a fluorescence-based instrument for the processing and analysis of ID NOW tests. This document describes the setup, configuration and operation of the ID NOW Instrument, which utilizes isothermal nucleic acid technology for the qualitative detection of a range of infectious diseases. It is intended to aid in the diagnosis of these diseases.
1.2 Product Description ID NOW utilizes isothermal nucleic acid amplification technology for the qualitative detection of infectious diseases. Consumables such as Test Bases and Sample Receivers are required to run each assay. The reaction tubes in the Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. ID NOW utilizes a pair of templates (similar to primers) for the specific amplification of the target nucleic acid and a fluorescently-labeled molecular beacon designed to specifically identify the amplified targets. To perform the assay, the Sample Receiver and Test Base are inserted into the ID NOW Instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, initiating target amplification. Heating, rotation and detection is provided by the instrument, with results automatically reported. Additional assay specific information and work flows are detailed in the respective product inserts.
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1.3 Instrument Specifications 1.3.1
Instrument
Color Touch Screen
3.5” 10/100 Mbps Ethernet Port for Data Transfer
Communications
3 x USB Ports for data export, barcode reader and printer 999 patient test results
Data storage
99 QC test results Memory allows search and retrieval Archive or export via USB
Power Supply
12V DC from external AC/DC supplied plug pack DC Voltage fluctuation: ±10% DC Current consumption: 12V DC, 3.0 Amps
Dimensions Weight
8.15” W x 5.71” H x 7.64” D 207 mm W x 145 mm H x 194 mm D 3.0 kg Indoor Use
Operating Environment
15ºC to 30ºC (50ºF to 86ºF) 10% to 80% RH (non-condensing) 0m (1.01 bar) to 2000m (0.763 bar) IP20 15ºC to 30ºC (50ºF to 86ºF)
Storage
10% to 80% RH (non-condensing) 0m (1.01 bar) to 2000m (0.763 bar)
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1.3.2
12V Power Supply
Rated input voltage:
100-240VAC
Rated input frequency:
50/60Hz
Rated input current:
1.2 Amps
Operating environment:
As per instrument
Storage environment:
As per instrument
Output voltage:
12V
Output current:
3.5 Amps
1.4 Unpacking Unpack the ID NOW Instrument and place on a clean, flat, level and stable surface within reach of an electrical outlet. The ID NOW Instrument has a carrying handle located on the back of the instrument for transport purposes. Use the carrying handle when removing the instrument from the box and when transporting short distances. Place instrument in a location where the air vents located in the back of the instrument will not be blocked. Avoid placing the instrument in direct sunlight. Inspect for any obvious signs of damage. Report any damage immediately to Abbott. Allow the instrument to equilibrate to room temperature for at least 30 minutes.
1.5 Instrument Calibration The ID NOW Instrument is factory calibrated and does not require any further calibration and verification. However, if the instrument was transported or moved, a performance check using ID NOW positive and negative controls is recommended to ensure proper functionality.
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1.6 Maintenance & Cleaning The ID NOW Instrument is maintenance-free and has no serviceable parts. In the case of instrument failure or damage, contact Abbott Technical Support. Acceptable cleaning agents include the following: •
70% ethanol - available in commercial wipes or on a damp, lint free cloth
•
10% bleach - on a damp, lint free cloth only
Do not spray or pour solution directly onto instrument when cleaning. Ensure no excess liquid is used when cleaning as it may damage the instrument. Abbott recommends that the exterior instrument surfaces and the surfaces visible under the open lid be cleaned daily. Clean surrounding bench area. Clean instrument and surrounding areas immediately after possible patient sample contamination. Do not disassemble the instrument for cleaning. Do not immerse in water or cleaning solutions. Do not clean with soap or other solutions.
1.7 Components The following items are supplied with the ID NOW Instrument: •
Power Supply and Adaptor
•
ID NOW Instrument User Manual
•
ID NOW Instrument Quick Start Guide
ID NOW Instrument User Manual 9
2 ID NOW INSTRUMENT at a GLANCE ™
ID NOW Instrument, Front View ™
Lid
LCD Color Display Screen
Test Base Holder
Sample Receiver Holder
Audio Speaker
LED Status Indicator
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ID NOW Instrument, Back View ™
USB Connection
Carrying Handle
Power Connection Power Button
Ethernet Connection
USB Connection x 2
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3 GETTING STARTED - SETUP For unpacking and calibration, see Sections 1.4 and 1.5.
3.1 Initial Setup Connect the 12V power supply to the instrument. Plug the appropriate, country specific adapter into an appropriate electrical outlet.
Power Up: Once the power is connected, press and hold the Power Button on the right side of the instrument to power up and start the instrument. Once the instrument is running, it may be turned off (shut down) by pressing and holding the Power Button for 3 seconds or longer. If the unit is unattended for one hour, the instrument will switch to power save mode, and the screen will go black. Touch the screen to return the unit to active display operation.
3.2 Instrument Status Light The lower right side of the front panel of the ID NOW Instrument includes a white light. This light should illuminate immediately when the instrument is powered up. The light statuses are: State
Indication
Slow flash
Starting up/ heaters not at temperature
On solid
Heaters at temperature
Fast flash
Software updates, Hardware fault, or shutting down
3.3 User Interface All Operator interactions with the ID NOW Instrument are performed using the instrument touch screen.
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3.4 Home Screen Home Screen: Displays buttons for access to: Home
• • • • • •
30/Jan/2018 10:12am
User ID
Run Test
Run QC Test
Review Memory
Preferences
Setup
Log Out
Run Test Run QC Test Review Memory Preferences Setup (Admin Access Only) Log Out
The current set time and date is displayed in the top right hand corner of the screen.
Main Menu – Home Screen
3.5 Navigation
Up & Down Arrows:
Preferences Language
English
Sound
Enabled
Brightness
Enable navigation to scroll through menus and increase/decrease setting values.
50%
Home:
About
Select Home at any time to return to the Home screen.
Example of Navigation Bar
3.6 Onscreen Keyboard
Q
#
W
E
R
T
Y
U
I
O
P
A
S
D
F
G
H
J
K
L
Z
X
C
V
B
N
M
1
#
2
3
4
5
6
7
8
9
0
/
:
;
(
)
$
&
@
“
+
=
.
,
?
!
‘
123
ABC
Onscreen QWERTY Keyboard & Numeric Keypad
The Onscreen QWERTY Keyboard & Numeric Keypad enable user input into the ID NOW Instrument. Press ‘123’ or ‘ABC’ to swap between text and number entry. Note: Barcode input will operate at any time in these screens and can add text as if entered via the onscreen keypad. Note: If Chinese language is selected, the Pinyin keyboard will be available. If Japanese is selected, Romaji will be available.
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3.7 Admin Setup Creating the Admin ID Create Admin Password
Q
#
W
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A
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The instrument requires one Admin user to be set up. The user-name is automatically set to ‘Admin’, but the password must be chosen. Admin User Name: Admin Admin Password chosen by Admin.
123
After power-up, the Create Admin Password screen will be displayed. The Admin user must type in their chosen password and press . Passwords are case-sensitive and must be alphanumeric. The password cannot contain spaces. Passwords must be 2-20 characters. The instrument will ask for confirmation of the password. If password is correct, press to advance to the next screen. If password is incorrect, press Cancel to return to the Create Admin Password screen. The Admin can set a rescue password in case the original is lost or forgotten.
Rescue Password Would you like to define a Rescue Password that can restore access if the Admin password is lost?
No
Yes
Use keyboard to enter the rescue password and reset password.
Recovery Key Please refer to user manual.
If rescue password is lost, an error screen will indicate 'Password Not Recognized'. Admin can choose 'Reset' and a Recovery Key will be automatically generated by the instrument.
Recovery Key: ####-####-####
Cancel
OK
Enter Reset Code [####-####-####]
Q
#
W
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Contact Abbott Technical Support with the Recovery Key. A Reset Code will be provided. Use Keyboard to enter reset code and press to advance to Enter a New Password.
123
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Setting the Date Set the correct date using the up and down arrow keys and the touch screen to move between day, month and year.
Date
3 / NOV / 2013
This screen will be displayed automatically following creation of Admin Password. OK
Press OK to advance.
Setting the Time Time 12 Hour
11 : 35
24 Hour
PM
Set the correct time using the up and down arrow keys, and choose between a 12 Hour or 24 Hour display using the touch screen. This screen will be displayed automatically once the date is set.
OK
Press OK to advance.
Self Test Self Test Running self test, please wait ...
Self Test Close lid to proceed.
The instrument will now run a Self Test before proceeding to the Home screen.
If the instrument lid is open, the instrument will prompt to close the lid before running the Self Test. The Self Test will not proceed until the lid is closed.
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Home Home
30/Jan/2018 10:12am
User ID
Run Test
Run QC Test
Review Memory
Preferences
Setup
Log Out
When initial set-up is complete, the Home screen will be displayed, with the current time and date shown in the top right, and User ID in top left corner of the screen. Abbott recommends that the Admin selects Setup to finish configuring the instrument and to add additional users. See Section 4 for details.
Alternatively, the Admin can run a test by selecting Run Test. When an assay or the instrument is used for the first time, or following a software upgrade, the user is required to run both a positive and a negative successful QC test before patient testing is allowed. See Sections 6 and 7 for details. If not ready to continue set up or run tests, Abbott recommends that the Admin logs out by selecting Log Out.
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4 SETUP MENU Home>Setup Setup Login
ID & Password Required
Users
99
The Setup screen allows the Admin to configure the instrument. Use the up and down arrows to scroll through menus. Settings are saved even when power is off.
Assay Preferences
Settings include: • Login • Users • Assay Preferences • Patient Details • Date • Time • Auto-logout • Network • Remote Mode • Connectivity • QC Lockout • Lot Management • Auto-Print • Reset to Factory Default
Patient Details
Chosen options are displayed to the right of each setting.
4.1 Log In (Admin Access Only) Home>Setup>Login
Log In allows the Admin to choose User ID password requirements to allow access to the instrument.
Log In
User ID Only User ID & Password
OK
If Users do not require passwords, select ‘User ID Only’ and press OK. If a password is preferred, select ‘User ID & Password’ and press OK.
The selected option will apply to all Users with the exception of the Admin, who will always be required to use a password when logging on as ‘Admin’. If the system is changed from User ID & Password to User ID Only, existing passwords are retained in the event the Admin selects User ID & Password in the future. If the system is changed from User ID Only to User ID & Password, user passwords are set to ‘password’ as a default, if a password has not been set previously for the user. The Admin can change each User’s password individually, as needed. ID NOW Instrument User Manual 17