Abbott DIGIVAL LFR-024 User manual

LFR-024
USER MANUAL
DIGIVAL™

DIGIVAL™User Manual
DIGIVAL
User Manual

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DIGIVAL User Manual 1
Contents
1 Introduction .................................................................................. 5
1.1 Intended Use .............................................................................................. 5
1.2 Product Description................................................................................... 5
2 Warnings and Safe Use................................................................. 6
3 DIGIVAL™at a Glance ................................................................. 8
4 Getting Started - Setup................................................................ 9
4.1 Unpacking and inspection ...................................................................9
4.2 Installation and operating conditions..................................................9
4.3 Power up and first time login.....................................................................11
5 DIGIVAL™Touchscreen ..............................................................13
5.1 Home Screen.............................................................................................13
5.2 Navigation............................................................................................13
5.3 Barcode Scanner/Onscreen Keyboard.....................................................14
6 DIGIVAL™Calibration ...............................................................15
7 Settings Menu (Admin Access Only) ..................................17
7.1 Date and Time (Admin Access Only) ......................................................17
7.2 Access Control...........................................................................................18
7.2.1 Login (Admin Access Only)...................................................................... 18
7.2.2 Operators (Admin Access Only) ............................................................. 19
7.2.2.1 Add a New Operator .......................................................................... 19
7.2.2.2 To delete Operators, or to change their password.....................................20
7.2.3 Auto Log Out (Admin Access Only)....................................................... 23
7.2.4 Set the Admin Password........................................................................... 23
7.3 Test Settings .......................................................................................24
7.3.1 Additional fields.......................................................................................... 24
7.3.2 Auto Print................................................................................................... 25
7.3.3 QC Schedule.............................................................................................. 25
7.3.4 Assays.......................................................................................................... 27
7.3.5 Walk Away Mode ....................................................................................... 27
7.3.6 Lot Management........................................................................................ 28
7.3.7 Blacklist....................................................................................................... 30

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7.4 Connectivity ..............................................................................................31
7.4.1 Network Interface Settings ...................................................................... 31
7.4.1.1 Network Interface Settings - Method..................................................... 32
7.4.1.2 Network Interface Settings - Other Properties..................................... 32
7.4.2 Middleware Settings .................................................................................. 33
7.4.3 Auto Upload Results.................................................................................. 33
7.4.4 Sync Settings.............................................................................................. 34
7.4.5 Purge Test Results...................................................................................... 34
7.4.6 Positive Patient ID..................................................................................... 35
7.5 Administration ...................................................................................35
8 Preferences Menu....................................................................... 36
8.1 Synchronize Now................................................................................36
8.2 Language.............................................................................................37
8.3 Sound..................................................................................................37
8.4 Screen .................................................................................................37
8.5 About (DIGIVAL™Information).............................................................38
8.6 Legal Notices............................................................................................38
9 Reading a Test ............................................................................. 39
10 Reading a QC Test ......................................................................43
11 Printing Test Results...................................................................46
12 Test History ................................................................................. 47
13 Software Updates........................................................................50
14 Care and Cleaning....................................................................... 52
15 Accessories .................................................................................. 53
16 Errors and Warnings ...................................................................54
16.1 Errors.........................................................................................................54
E.1 Calibration Check Required ........................................................................... 54
E.2 Login Failed...................................................................................................... 54
E.3 Operator ID in Use......................................................................................... 54
E.4 Operator ID Invalid ........................................................................................ 54
E.5 Operator Not Certified.................................................................................. 54
E.6 Drawer Open .................................................................................................. 55
E.7 Test Device ID Invalid..................................................................................... 55
E.8 Test Type Not Supported............................................................................... 55

DIGIVAL User Manual 3
E.9 Test Device Expired ........................................................................................ 55
E.10 Tray Barcode Read Failure ........................................................................... 55
E.11 QC Test Required .......................................................................................... 55
E.12 Incorrect Tray................................................................................................. 56
E.13 Patient ID Invalid........................................................................................... 56
E.14 Test Device QR Code Read Failure ............................................................ 56
E.15 Test Device ID Mismatch ............................................................................. 56
E.16 Test Device Present....................................................................................... 56
E.17 Calibration Check Card Expired.................................................................. 56
E.18 Calibration Check Card QR Code Read Failure ....................................... 57
E.19 Password Invalid............................................................................................. 57
E.20 Password Mismatch ..................................................................................... 57
E.21 Update File Not Found................................................................................. 57
E.22 Network Error............................................................................................... 57
E.23 Test Upload Failed - Server ......................................................................... 57
E.24 Test History Export...................................................................................... 58
E.25 Operator Limit Reached.............................................................................. 58
E.26 Log Export Failed.......................................................................................... 58
E.27 Last Name Invalid ......................................................................................... 58
E.28 Date of Birth Invalid..................................................................................... 58
E.29 Drawer Open ............................................................................................... 58
E.30 Assay Add Error........................................................................................... 58
E.31 QC Lot Number Invalid................................................................................ 59
E.32 Operator Import Failed................................................................................ 59
E.33 Operator Export Failed................................................................................ 59
E.34 Multiple Update Files Found....................................................................... 59
E.35 Synchronization Failed - Network.............................................................. 59
E.36 Synchronization Failed - Server.................................................................. 59
E.37 Positive Patent ID Failed - General............................................................ 59
E.38 Assay Lot Number is Locked Out .............................................................. 60
E.39 Patient ID Lockout....................................................................................... 60
E.40 Patient Information Lockout ...................................................................... 60
E.41 Input Invalid ................................................................................................... 60
E.42 Barcode Invalid ............................................................................................. 60
E.43 Lot ID Add Failed......................................................................................... 60
E.44 Lots Import Failed........................................................................................ 60
E.45 Lots Exports Failed....................................................................................... 60

DIGIVAL User Manual
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16.2 Critical Errors ..................................................................................... 61
CE.1 Test Device Read Failure.............................................................................. 61
CE.2 Calibration Check Card Read Failure........................................................ 61
CE.3 DIGIVAL™Instrument Fault...................................................................... 61
CE.4 Update Failed............................................................................................... 61
16.3 Warnings............................................................................................. 61
W.1 Memory Almost Full ...................................................................................... 61
W.2 Memory Full................................................................................................... 61
W.3 Auto Log Out................................................................................................. 61
W.4 DIGIVAL™ Restart Required ....................................................................... 61
W.5 DIGIVAL™ Restart Required ....................................................................... 62
W.6 Delete All Test History ................................................................................. 62
W.6.1 Delete All Patient Tests............................................................................. 62
W.6.2 Delete All QC Tests................................................................................... 62
W.6.3 Delete All Calibration Checks.................................................................. 62
W.7 Factory Reset ................................................................................................ 62
W.8 Calibration Check Card Expiring................................................................. 62
W.9 Test Cancellation Attempt............................................................................ 63
W.10 Import All Operators................................................................................... 63
W.11 Patient ID unknown...................................................................................... 63
W.12 Patient Information is Incorrect ................................................................. 63
W.13 QC Test Recommended.............................................................................. 63
W.14 Low Battery .................................................................................................. 63
W.15 Power O Confirmation ............................................................................. 63
17 Symbols .......................................................................................64
18 DIGIVAL™Specifications...........................................................66
18.1 DIGIVAL™...............................................................................................66
18.2 Power Supply............................................................................................ 67
19 Warranty (EN) ............................................................................68
20 Ordering and Contact Information ...........................................70
20.1 Reorder numbers................................................................................70
20.2 Abbott Contact Information .............................................................70

DIGIVAL User Manual 5
1.1 Intended Use
The DIGIVAL™is a small bench top instrument to be used in conjunction with
Abbott rapid assays. It is intended for professional and laboratory use only.
This document describes the setup, configuration and operation of the DIGIVAL
for the qualitative detection of selected Abbott Rapid Tests. Please refer to each
specific package insert for details on running the individual tests.
1.2 Product Description
The DIGIVAL captures, interprets, and transmits results of select Abbott
Rapid Tests. It can be used in the laboratory and point of care settings. It is a
camera-based instrument that detects the presence and identity of a completed
rapid test, analyzes the test and control line, and displays the results (positive,
negative or invalid) on a display screen. Results can be printed using an accessory
printer connected via USB. In addition, patient test results can be uploaded to a
compatible data management system via Ethernet.
When a test is placed in the DIGIVAL, the DIGIVAL identifies the test device
type and type of assay by reading the barcodes. It then selects the appropriate
test parameters, performs the analysis, and reports results on the screen. Results
are stored in memory, and can be printed, if desired, on an optional printer. If
connected to a data management system, results are uploaded and are no longer
available in memory.
1 Introduction

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Warning: Failure to comply with the user manual could lead to inaccurate
results.
Caution: Use only the power supply that is provided with the DIGIVAL. Use
the appropriate adaptor on the provided power supply for the region. The
correct power supply is required to maintain the safety and electromagnetic
compatibility of the DIGIVAL.
Caution: Always operate the DIGIVAL on a clean, flat, level and stable
surface not in direct sunlight. Do not drop the DIGIVAL.
Caution: Never move the DIGIVAL 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. Clean DIGIVAL and surrounding
surfaces according to instructions provided in Section 14, “Care & Cleaning.”
Caution: Risk of electrical shock. Do not operate the DIGIVAL 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 DIGIVAL or other
accessories as there is a risk of damage to the DIGIVAL. The DIGIVAL does
not contain serviceable parts and should be returned for repair. Disassembling
the DIGIVAL will also void the warranty.
Caution: Only operate the DIGIVAL for its intended purpose and in
accordance with this user manual and warnings. If the DIGIVAL is used
in a manner not specified in the user manual, protection provided by the
equipment will be impaired. The DIGIVAL (including power supply) is
designed to operate within the manufacturer’s specifications. Do not exceed
the manufacturer specifications when in use.
Caution: Position the DIGIVAL with clear access to connectors. Keep
connected cables clear of work areas such that tripping or catching will not
pull the DIGIVAL o its work bench. The mains socket outlet intended for
use with DIGIVAL power supply should be located near the DIGIVAL 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.
2 Warnings and Safe Use

DIGIVAL User Manual 7
Caution: Do not immerse in water or cleaning solutions.
Caution: Clean only with indicated solutions.
Caution: Patient ID and Test Type cannot be edited once testing has begun.
Caution: Do NOT open the DIGIVAL drawer during testing. The test is not
saved until the completed result is displayed.
Caution: Do not reinsert test device once a result has been reported.
Caution: Do not remove the USB memory stick during the software update.
Caution: Care should be taken when handling the tests to avoid potential
contamination from debris such as lint, hair and other particulates as these
may cause false results.

DIGIVAL User Manual
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1
2
1
345
2
1
3 DIGIVAL™at a Glance
DIGIVAL™, Front View
1
Power On/O Button
2
Test Insert Tray
DIGIVAL™, Back View
1
Barcode scanner bracket location holes
2
USB port (x1)
3
Power connection
4
Ethernet
5
USB ports (x2)

DIGIVAL User Manual 9
4 Getting Started - Setup
4.1 Unpacking and inspection
Carefully open packages containing the DIGIVAL and barcode scanner.
Inspect the shipping boxes, DIGIVAL and barcode scanner for signs of
damage. If any equipment is damaged, notify Abbott immediately.
Check to make sure that the following components are included in the
packaging:
• DIGIVAL and power cord/adapter
• Barcode Scanner Bracket
• DIGIVAL User Manual
• DIGIVAL Quick Start Guide
• Abbott USB Memory Stick
A separate package contains:
• Barcode Scanner
• Barcode Scanner Holster and thumbscrew
• Test insert tray pack (assay specific)
• Calibration Check Card Pack
4.2 Installation and operating conditions
Cautions:
Always operate the DIGIVAL on a clean, flat, level and stable surface not in
direct sunlight. Do not drop the DIGIVAL.
Position the DIGIVAL with clear access to connectors. Keep connected
cables clear of work areas such that tripping or catching will not pull the
DIGIVAL o its work bench. The mains socket outlet intended for use
with DIGIVAL power supply should be located near the DIGIVAL and
be readily accessible. Abbott recommends that cables are disconnected
when not in use for an extended period. Use only the power supply that
is provided with the DIGIVAL. Use the appropriate power supply for the
region. The correct power supply is required to maintain the safety and
electromagnetic compatibility of the DIGIVAL.
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.

DIGIVAL User Manual
10
1. Place the DIGIVAL on a clean, flat, level and stable surface within reach
of an electrical outlet. Avoid placing the DIGIVAL in direct sunlight.
Allow sucient space to open and close the drawer and to connect the
accessories to the connection ports which are located at the back of the
DIGIVAL.
2. At first time use, allow the DIGIVAL to adjust to room temperature for at
least 30 minutes before using.
3. Connect the barcode scanner
holster to the bracket provided
with the DIGIVAL, using the
thumbscrew.
4. Connect the bracket assembly to
the back of the DIGIVAL.
5. Place the barcode scanner in the
holster and connect to the USB
port at the back of the DIGIVAL.
6. Connect printer to the USB port
at the back of the DIGIVAL.
(optional)
7. Connect the 12V power cord/
adapter to the DIGIVAL. Plug
the appropriate, country-specific
adapter into an appropriate
electrical outlet.

DIGIVAL User Manual 11
4.3 Power up and first time login
8. Power Up: With the power
connected, press the Power
Button on the front of the
DIGIVAL to power up and start
the DIGIVAL. The power button
lights up, and the Scan or Enter
Operator ID screen displays.
Once the instrument is running,
it may be turned o (shut down)
by pressing and holding the
Power Button for 10 seconds or
longer.
Figure 1: Power up screen
Note: The instrument is intended to be used with external power connected. A battery
with lightning symbol will appear when power is connected. When disconnected from
power, a battery symbol will appear with 3 (or less) bars, depending on remaining
charge. When battery level drops to 30%, a Warning message will appear.
To set up your system for the first time, follow the steps below.
• Log in as admin
• Set the date and time
• Set the admin password
• Create operator(s)
• Log out
• Log in as an operator
• Perform a calibration check
1. Log in as "Admin"
The first user to power up the system can log in as "admin." To log in:
Scan or Enter Operator ID: Enter 'Admin' as the login name.
Password: Enter 'admin' for the password.

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2. Set the date and time
To set the date and time, tap:
Settings>Set date and time
See Section 7.1, "Date and Time" for more detail.
3. Set the Admin password
To set the Admin password, tap:
Settings>Access Control>Admin password
Enter the new Admin password. See Section 7.2.4, "Set the Admin password" for
more detail.
4. Select operator login option
To select options, tap:
Settings>Access Control>Login
Select Operator ID only or Operator ID and Password. See section 7.2.1 for
more detail.
5. Create operator(s)
To create operator login permissions, tap:
Settings>Access Control>Operators>Actions>Add
Add at least one operator so that you can perform a Calibration Check. You can
return to this screen to add the rest of the sta at any time.
See Section 7.2.2.1, "Add a new Operator."
6. Log out as the admin
To log out, tap:
Home>Log Out
7. Log in as one of the newly created operators.
Scan or Enter Operator ID: Enter the operator login name and tap OK.
Password: If a password was specified in the Create operator screen, you will be
asked to enter your assigned password. Enter it and then tap OK.
8. Perform a Calibration Check
When the DIGIVAL is powered on for the first time it will require a calibration
check using the provided Calibration Check Card.
To start the check, tap:
Home>Calibration Check
Screen instructions guide you through the Calibration Check procedure. See
Section 6, "DIGIVAL Calibration" for more detail.

DIGIVAL User Manual 13
5 DIGIVAL™Touchscreen
Information can be entered into the DIGIVAL by tapping the appropriate
touchscreen keys, or by using the barcode scanner.
5.1 Home Screen
Figure 2: Home Screen
Home Screen: Displays buttons for access to:
• Read a Test – See Section 9, “Reading a Test”
• Read QC Test– See Section 10, “Reading a QC Test”
• Calibration Check– See Section 6, “DIGIVAL Calibration.”
• Test History– See Section 12, “Test History.”
• Settings (Admin only) – See Section 7, “Settings Menu.”
• Preferences– See Section 8, “Preferences Menu.”
• Log Out
The time, date and battery status are displayed in the top right hand corner of
the screen. The currently logged in Operator is displayed at the upper left of
the screen.
5.2 Navigation
Figure 3: Preferences menu with navigation bars
Tap navigation arrows to scroll through menus and advance to submenus.
Home: Tap the Home icon at any time to return to the Home Screen.

DIGIVAL User Manual
14
5.3 Barcode Scanner/Onscreen Keyboard
Two onscreen keyboards (QWERTY and Numeric) are used to enter specific
information into the DIGIVAL. Use the ?123 or Abc keys to switch between
the alphanumeric and numeric keypads. Information can be entered by tapping
the keypad keys or by scanning with the barcode scanner.
Read Test
Abc
? 123
ã
Ç
?
‚
Õß
,
Scan or Enter Test Device ID Step 1 of 9
Figure 4: QWERTY Keyboard
ABC
2/2
€
«
/
»"”“;&
‘
<
l_§{ }
!?
£$¥ %<>[ ]
Abc
Read Test
Step 1 of 9Scan or Enter Test Device ID
Figure 5: Numeric Keypad 1/2
ABC
1/2
1
@
,
~/\‘;:
*#+-=( )!?
234567890
Abc
Read Test
Step 1 of 9Scan or Enter Test Device ID
Figure 6: Numeric Keypad 2/2