Quidel Solana User manual

1
Solana User Manual

2
Quidel Corporation
Worldwide Headquarters
12544 High Bluff Drive
San Diego, CA 92130
United States
quidel.com
858.552.1100
MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

3
Table of Contents
Table of Contents .................................................................................................................................................... 3
General Information................................................................................................................................................ 5
Quidel Contact Information ................................................................................................................................ 5
Labels and Symbols ............................................................................................................................................. 5
Brief Warnings, Precautions and Limitations...................................................................................................... 7
Safety Precautions........................................................................................................................................... 7
Intended Use....................................................................................................................................................... 8
Product Description............................................................................................................................................. 8
System Components ........................................................................................................................................... 9
System Display .................................................................................................................................................... 9
Functional Description .......................................................................................................................................... 10
Hardware........................................................................................................................................................... 10
Set-up and Connection Procedures ...................................................................................................................... 12
Unpacking of Solana.......................................................................................................................................... 12
Placement of Solana.......................................................................................................................................... 12
Unlocking Solana............................................................................................................................................... 13
AC Power Connection........................................................................................................................................ 13
Plugging and Unplugging Solana ....................................................................................................................... 13
General Operation................................................................................................................................................. 14
Procedural Notes............................................................................................................................................... 14
Startup Solana ................................................................................................................................................... 15
Power Up....................................................................................................................................................... 15
User Login.......................................................................................................................................................... 16
Main Menu........................................................................................................................................................ 17
User Logout ....................................................................................................................................................... 17
System................................................................................................................................................................... 18
Settings.............................................................................................................................................................. 19
Workflow Settings ......................................................................................................................................... 19
Order Settings............................................................................................................................................ 20
Result Handling.......................................................................................................................................... 21
Device Settings .............................................................................................................................................. 21
Date and Time ........................................................................................................................................... 22
Language ................................................................................................................................................... 23
User Access Control................................................................................................................................... 23
Network Settings....................................................................................................................................... 26
Brightness.................................................................................................................................................. 29
Delete Patient Info in All Records.............................................................................................................. 30
Maintenance ..................................................................................................................................................... 30
Virena Status ................................................................................................................................................. 30
LIS Status ....................................................................................................................................................... 31
Software / Test Methods / Report Template................................................................................................ 32
Install Software Update............................................................................................................................. 32
Manage Methods ...................................................................................................................................... 33
Report Template........................................................................................................................................ 34
Event Log ....................................................................................................................................................... 34
Transport Lock............................................................................................................................................... 34
Start New Test....................................................................................................................................................... 35
Starting New Test (Test Selection: Autofill Mode Off)...................................................................................... 35

4
Starting New Test (Test Selection: Autofill Mode On) ...................................................................................... 37
One Test Per Run........................................................................................................................................... 37
Procedure to Run Different Assays in the Same Batch ................................................................................. 39
Assigning Sample Type and ID........................................................................................................................... 40
Auto Sample Order Off.................................................................................................................................. 40
Patient Samples......................................................................................................................................... 40
QC Samples................................................................................................................................................ 41
Auto Sample Order On .................................................................................................................................. 42
Patient Samples......................................................................................................................................... 42
QC Samples.................................................................................................................................................... 43
Test in Progress ................................................................................................................................................. 43
Sample Assignment or Editing Sample ID During the Run ................................................................................ 44
LIS Orders .............................................................................................................................................................. 45
LIS Order Assignment ........................................................................................................................................ 45
Review and Managing Results .............................................................................................................................. 49
View Results ...................................................................................................................................................... 49
Managing Results .............................................................................................................................................. 50
Shutdown .............................................................................................................................................................. 51
Maintenance and Cleaning ................................................................................................................................... 52
Troubleshooting .................................................................................................................................................... 52
Technical Specifications ........................................................................................................................................ 61
Mechanical Data and Hardware Features............................................................................................................. 61
Optics .................................................................................................................................................................... 62
Power Requirements of the Instrument ............................................................................................................... 62
Accessories.......................................................................................................................................................... 622

5
General Information
Quidel Contact Information
Website: quidel.com
Technical Support
Monday through Friday, 8:00 AM to 5:00 PM Eastern Standard Time
Tel: [phone] (in the United States);
858.552.1100 (outside the United States);
Fax: [phone]
E-mail: [e-mail] or contact your local distributor
Customer Service
Monday through Friday, 8:00 AM to 5:00 PM Eastern Standard Time
Tel: [phone] (in the United States);
858.552.1100 (outside the United States);
Fax: [phone]
E-mail: customerservic[email protected]

6
Labels and Symbols
Label
Description
Manufacturer
In vitro diagnostics
CE mark of conformity (Conformité Européenne)
Consult instructions for use
Authorized representative in the European Community
Temperature limitation
Directive 2002/96/EC on waste electrical and electronic equipment (WEEE)
Serial number
Catalog number
Information of particular importance
Warning! Indicates a hazardous situation, which if not avoided, could result in
injury to the Operator or a bystander (e.g., electrical shock or UV exposure).
Potential Biohazard! An agent of biological origin that has the capacity to
produce deleterious effects on humans, i.e. microorganisms, toxins, and
allergens derived from those organisms; and allergens and toxins derived from
higher plants and animals.
Caution! Indicates a situation, which if not avoided could result in damage to
the device or incorrect results.

7
Brief Warnings, Precautions and Limitations
Always operate Solana on a surface that is level, dry, and stable, and away from direct intense lighting.
Highly intense light and vibrations may influence results and must be avoided.
Never move Solana while in operation or in the unlocked position.
Do not expose Solana to strong electromagnetic radiation.
Do not use a power adapter other than the adapter provided with Solana.
Do not drop Solana as it could damage the unit.
Never place objects on top of Solana.
Never start testing without reaction tubes inserted.
Do not re-open/open the lid of the reaction tube once it has been closed.
Pouring liquids into testing wells can damage Solana.
Maintenance and decontamination of workspace and equipment should follow and be performed
according to established laboratory protocols and schedules.
Turn off Solana when not in use.
Safety Precautions
Solana is designed to provide safe and reliable operation when used in accordance with instructions in this
User Manual. If Solana is used in a manner not specified in the User Manual, the protection provided by the
equipment may be impaired.
All warnings and precautions should be followed to minimize personal injury or damage to the device.
Warning!
To reduce the risk of electrical shock:
Unplug Solana before cleaning.
Plug the device into an approved, properly installed receptacle.
Do not immerse in water or cleaning solutions.
Do not open instrument housing or disassemble the device.
Use the appropriate power cord for the region.
Failure to follow these warnings invalidates the warranty.
Potential Biohazard!
To reduce the risk of biohazard:
Treat specimens as potentially biohazardous material.

8
Dispose of used specimens in accordance with applicable local, regional, and national requirements.
Clean Solana per the Maintenance and Cleaning section prior to storage, transport, or disposal.
Seek specific training or guidance if you are not experienced with specimen collection and handling
procedures.
Use nitrile, latex, or other impermeable disposable gloves when handling patient specimens or known
positive samples.
Caution!
To reduce the risk of incorrect results:
Trained and qualified operators should operate Solana.
Refer to the assay-specific package insert for details on specific tests.
Use the assay kit before the expiration date.
To reduce the risk of Solana damage:
Solana is designed for countertop operation under normal laboratory conditions.
Solana is not designed to withstand moisture, extreme humidity, or extreme temperatures.
Solana is not designed to withstand severe shock or vibration.
Do not open instrument housing or disassemble the device.
Do not use bleach on the tube holder.
Failure to follow the precautions mentioned above invalidates the warranty.
To reduce the risk of environmental contamination:
If the inside of the Solana is contaminated, please contact Quidel Technical Support.
Clean Solana per the Maintenance and Cleaning section prior to return or disposal.
Dispose of Solana and accessories in accordance with local, regional, and national requirements.
Intended Use
Solana is a standalone instrument which is able to run up to 12 tubes of Solana diagnostic assays.
It should only be used according to the safety precautions outlined in the Brief Warnings, Precautions and
Limitations section. Solana is only compatible with Quidel Solana assays run by trained qualified personnel.
Product Description
Solana uses isothermal, helicase-dependent amplification and fluorescent, probe-based detection that is
illuminated by an ultraviolet (UV) and visible light source to generate specific results.
Each reaction tube contains an internal process control that is also read via fluorescence. This ensures that
amplification has occurred within the reaction tube to permit an accurate reading.

9
Solana then displays the test results to the user (e.g., Positive, Negative, Invalid) on the screen. These results
can be printed on an integrated or networked printer, saved on a USB flash drive, and/or sent to a LIS.
System Components
The following system components are supplied by Quidel:
Solana instrument
Power supply and cords
Ethernet cord
Dymo LabelWriter 450 printer
Dymo LabelWriter 450 printer labels
Stylus
To place an order, please contact or fax Quidel Customer Service.
Solana consumable assay reagent kits and External Quality Control materials are provided separately.
Contact Quidel Customer Service or visit the Quidel website for a list of approved Solana assays.
System Display
Solana has a 6 inch × 3.5 inch color touchscreen user interface.

10
Functional Description
Hardware
Figure 1, Figure 2, and Figure 3 identify the components of the Solana instrument.
Figure 1

11
Figure 2
Figure 3

12
Set-up and Connection Procedures
Unpacking of Solana
Inspect the shipping container for obvious damage prior to opening. Unpack the contents, placing Solana
upright on a dry, stable, and level surface. Carefully examine the Solana for damage. Check that all other
system components are provided (see System Components section) and are in good condition.
In case of damage or any missing parts, contact Quidel Technical Support.
Placement of Solana
The Solana is portable and can be moved to a suitable location for testing or storage.
When moving the instrument, lock the mechanical transport lock. See the Transport Lock section for
instructions on locking the unit and shutting down.
The Solana must be placed on a dry, stable, and level surface and within the operating conditions specified in
the Technical Specifications section. The location needs to be within reach of an appropriate wall electrical
outlet and other wired connections (e.g., Dymo printer). In addition, it should be placed with enough
surrounding space to perform the following functions:
Easily open and close the tube lid heater to insert or remove the reaction tubes
Access all connection ports on the back of the unit, such as the connector for the power supply, in case of
emergency or under abnormal operating conditions
The measured signal may change due to following:
Changes in ambient light levels
Contamination of the optical parts
Electromagnetic interference
Temperature changes
Mechanical movements (vibrations)
Do not place Solana in a location that is subject to vibrations, such as near machines that vibrate, shake,
or spin. Solana is a highly sensitive and precise optical device.
Do not place Solana near sources of intense light (e.g., direct sunlight). Solana has internal correction for
normal levels of ambient light, but highly intense light falling into the tube holder port may cause significant
interference with the measurement.
Do not place Solana directly next to a microwave or source of electromagnetic interference.
Do not expose Solana to ambient temperatures above 35C.

13
Unlocking Solana
Before powering up Solana, ensure the mechanical transport is unlocked. See Figure 3 for the location of
the transport lock.
To access the transport lock, place Solana on a stable surface. Facing the front of the device, tilt the device to
stand on its left side. Unlock the unit by sliding the lever to the unlocked position (see Figure 4).
Figure 4
AC Power Connection
Solana operates at: 100–240 VAC, 0.5 A, 50–60 Hz.
Use the provided power supply only. Use of a temporary power cord (e.g., extension cords, power strips) is
to be avoided.
Connect Solana to a properly installed electrical outlet.
Plugging and Unplugging Solana
With the flat side of the instrument connector facing down, plug the instrument connector into the power
port in the back of Solana (see Figure 5).
Plug the outlet connector to a properly installed electrical outlet.
Figure 5

14
To unplug the unit, hold the instrument connector (Figure 6) and unplug from the instrument port. Do not
unplug by pulling on the cord.
Figure 6
General Operation
Procedural Notes
Within this document, text in bolded, purple-colored font indicates hyperlinks in the electronic document.
The default user ID and password for the Administrator is “Admin” and “admin”, respectively. Passwords
should be changed and managed in accordance with your organization’s procedures. A temporary (valid for 24
hours) Administrator-level password can be obtained by contacting Quidel Technical Support.
Solana has a touchscreen display. Touch the icon to select the option. To type information, touch the entry
field to activate the touchscreen keypad and touch the keys on the screen.
Touch the green checkmark button to confirm/save changes, selections, or actions on most screens.
Touch the red stop button to cancel/exit changes, selections, or processing on most screens.
Touch the Home button to go to the Main Menu.
Buttons that are grayed out represent actions that are not available. For example, the network button
is grayed out because Solana is not connected to the network.
Solana goes to sleep after 20 minutes in idle mode. Press and hold the power button to activate Solana.
After 2 hours in idle mode, Solana turns off.

15
Startup Solana
Power Up
Before powering up, make sure the mechanical transport lock is unlocked (see Unlocking Solana
section).
Press and hold the power button (Figure 1) for approximately 2 seconds.
The display screen lights up with the Quidel logo. The system boots up and the power indicator light turns
green.
If a message to unlock the transport lock is displayed (Figure 7), touch the button after confirming
the unit is unlocked. Note: This message does not appear if the unit was powered down using normal
shutdown procedures (shutdown without locking the device).
Figure 7
During bootup, Solana displays a self-check screen (Figure 8). An internal check is performed to ensure that
values from internal reference standards are within a defined range. Solana compares internal settings with an
internal solid fluorescence standard. In case of a failure, please refer to the Troubleshooting section.

16
Figure 8
User Login
If User Access Control is turned On, the login screen is displayed (Figure 9) and the user must enter the User ID
and Password to proceed to the Main Menu. If User Access Control is turned Off, login is not required and the
Main Menu appears. See Main Menu section below. Refer to the User Access Control section for details on
modifying this feature.
Type in the User ID and Password information.
Alternatively, scan a barcode with user ID.
Touch the Enter (return) key to enter the settings.
The Main Menu (Figure 10) appears if the login information entered is correct and the instrument passes
internal calibration.
Figure 9

17
Main Menu
The following choices are available on the Main Menu (Figure 10).
New Test: to start a new test
Review Results: to show the results of completed tests
System: to change the workflow and device settings, access maintenance features, and retrieve
instrument information
LIS Orders (if LIS server connection is On): to view LIS orders received
User Log-out
Figure 10
The options are described in separate sections below.
User Logout
If User Access Control is On, each user should log out after use.
Touch the logout icon in the Main Menu (Figure 10).
Touch the button to confirm logout (Figure 11).

18
Figure 11
System
There are 3 choices on the System menu (Figure 12).
Settings
Maintenance
Info
Figure 12
The Info option displays the instrument software version, Linux version, device serial number and build.
Changes to Settings and Maintenance are saved and applied to subsequent uses of the device. It is suggested
to review System: Settings prior to using Solana the first time.

19
Settings
There are two types of settings (Figure 13):
Workflow Settings
Device Settings
Figure 13
Workflow Settings
Within Workflow Settings, the following can be configured (Figure 14):
Order Settings
Result Handling
Figure 14

20
Order Settings
Within Order Settings, the following can be configured (Figure 15).
Test Selection Autofill
Sample Ordering Auto Sample Order
Figure 15
Test Selection: The default autofill setting is Off. See Start New Test sections for more information on test
selection.
Autofill Off –This option allows the user to select the test method first, then assign the selected test to
individual sample tubes, in any order. Selection of a test does not need to be repeated for each tube.
Autofill On –This option allows the user to select the tubes first, then assign the test method by selecting the
test one time.
To change the displayed setting, touch the On/Off icon.
Touch the button to confirm the selection.
Sample ordering: The default Auto Sample Order is Off. See Assigning Sample Type and ID section for more
information on sample ordering.
Auto Sample Order Off –This option allows the user to assign a single sample ID to multiple tubes. The sample
ID entry does not need to be repeated for each tube.
Auto Sample Order On –This option allows the user to automatically assign a sample ID to the next tube. This
setting is helpful when scanning in barcodes for patient specimens in sequential order.
To change the displayed setting, touch the On/Off icon.
Touch the button to confirm the selection.