Global Point of Care
Just received your DIGIVAL™?
Follow the 4 easy steps: Installation, Run Calibration Check, Read QC Test, and Read Patient Sample to begin setting up your DIGIVAL. Click on each step below to reveal the instructions and get started.
When you have successfully installed your DIGIVAL, please let us know by clicking the button in the ‘Installation Complete’ section at the end of this guide.
In Step 1 you will unpack and check all contents for damage and familiarize yourself with DIGIVAL. Then set it up and log in for the first time.
Unpack you equipment and check contents for damage.
Check to make sure that the following components are included in the packaging:
A separate package contains:
LFR-000
LFR-024
DIGIVAL
Barcode scanner bracket
INLFR000
INLFR024
DIGIVAL User Manual
LFR-004
BinaxNOW™ Insert Tray Pack
OPR2001ZWU1-201
L22XWU1-200
Barcode scanner and holster
Power Supply
LFR-003
Calibration Check Card Pack
MCP181035
Printer
EQ004003
Abbott USB Memory Stick
When logging in for the first time you will need to:
a) Log In as Admin
b) Set the date
c) Set the time
d) Set the admin password
e) Create operator(s)
f) Set Walk Away or Read Now mode
g) Log out
a) Power up and Log in as “admin”.
b) Set the date.
c) Set the time.
d) Set the new Admin password.
Note: If the Admin password is forgotten the Admin must contact Abbott™ Technical Support.
e) Create operators
f) Set Walk Away or Read Now mode
g) Log Out
A Calibration Check must be performed before the first test can be processed and then at least every 30 days after initial calibration check.
a) Login
b) Select Calibration Check on the home screen
c) Remove Tray
Remove Insert Tray
Insert Calibration Check Card
d) Review Result
e) Replace Tray
NOTE: Return the calibration check card to the light-block bag in which in it was delivered. The calibration check card must always be stored in the light block bag when not in use.
BinaxNOW™ Influenza A & B Card 2 kits contain Influenza A & B Positive and Viral Negative Control Swabs. The Influenza A and B Positive Control swab should generate a positive result for both Influenza A and B when read by DIGIVAL the positive result will be displayed as Passed. These swabs will monitor the entire assay. Test these swabs with each new shipment received and once for each untrained operator. Other controls may be tested in order to conform with: local, state and/or federal regulations, accrediting groups, and/or, your lab’s standard Quality Control procedures.
When DIGIVAL is switched on, or after another Operator has logged out, the Scan or Enter Operator ID screen will be displayed. Enter the Operator ID using the barcode scanner or enter manually using the keyboard by pressing Abc. If a password is required (as specified by the Admin during setup) a prompt will appear to enter the password.
To Read QC test tap home > Read QC test
a) Scan or enter test device ID.
b) Select QC test to be run.
c) Refer to Package Insert for QC preparation and test procedure.
d) Enter QC standard ID, if configured. Home > Test Settings > QC Standard ID.
e) Insert test at appropriate time depending on Read Now or Walk away mode.
Read Now mode - At the read time indicated in assay instructions, open drawer, insert test device and close drawer.
Walk away mode - Once procedure is complete and the test device is securely closed, immediately open drawer, insert test device and close drawer. Reader will time the test completion for the user.
f) When test completes successfully remove test card.
g) Repeat Steps for each QC control needed.
NOTE:If the QC controls do not perform as expected, repeat the external control testing process. You may also contact your Supervisor or DIGIVAL Technical Support at 1.888.735.5317 for assistance before testing patient specimens. |
When DIGIVAL is switched on, or after another Operator has logged out, the Scan or Enter Operator ID screen will be displayed. Enter the Operator ID using the barcode scanner or enter manually using the keyboard by pressing Abc. If a password is required (as specified by the Admin during setup) a prompt will appear to enter the password.
1. Tap Read Test
a) Scan or enter the test device ID.
b) Scan or enter patient ID.
c) Confirm Patient and Test information. Patient information and Test Type cannot be edited once testing has begun.
d) Refer to the assay Package Insert for sample preparation and assay procedure.
e) Insert test device at the appropriate time depending on read mode.
Read Now mode - At the read time indicated in assay instructions, open drawer insert test device and close drawer.
Walk away mode - Once procedure is complete and the test device is securely closed, immediately open drawer, insert test device and close drawer. Digival will time the test completion for the user and read the result at the read time.
f) When test completes successfully, results are displayed on the screen with positive or negative results.
g) If optional printer is setup tap print to print the result.
h) Open the drawer and discard the test device.
DIGIVAL is maintenance-free and has no serviceable parts. In case of Digival failure or damage, contact Abbott Technical Support 1.888.735.5317
Cleaning the DIGIVAL surfaces and test device tray:
Clean the exterior DIGIVAL surfaces and the test device tray daily, and immediately after possible patient sample contamination. Use a lint free cloth and a 70% ethanol, 70% isopropanol or 10% bleach solution. Do not spray or pour solution directly onto the DIGIVAL when cleaning. Ensure no excess liquid is used when cleaning as it may damage the DIGIVAL.
Clean surrounding bench area. Clean DIGIVAL and surrounding area immediately after possible patient sample contamination.
If you need additional assistance you may request a call from technical services or call directly.
For immediate help, call technical services at 1.888.735.5317.
When you have successfully completed the online installation program, please let us know by clicking the button below.
To view the package insert and other helpful documents, click here.
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