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 ................................................................................................................................... 6
Quidel Contact Information ................................................................................................................................ 6
Labels and Symbols ............................................................................................................................................. 7
Brief Warnings, Precautions and Limitations...................................................................................................... 8
Safety Precautions........................................................................................................................................... 8
Intended Use..................................................................................................................................................... 10
Product Description........................................................................................................................................... 10
System Components ......................................................................................................................................... 10
System Display .................................................................................................................................................. 10
Functional Description.............................................................................................................................. 11
Hardware........................................................................................................................................................... 11
Set-up and Connection Procedures............................................................................................................ 13
Unpacking of Solana.......................................................................................................................................... 13
Placement of Solana.......................................................................................................................................... 13
AC Power Connection........................................................................................................................................ 14
Plugging and Unplugging Solana....................................................................................................................... 14
Locking and Unlocking Solana........................................................................................................................... 15
Transport Lock............................................................................................................................................... 15
Startup Solana................................................................................................................................................... 17
Power Up ....................................................................................................................................................... 17
General Operation.................................................................................................................................... 18
Procedural Notes............................................................................................................................................... 18
User Login.......................................................................................................................................................... 19
User Logout ....................................................................................................................................................... 20
Main Menu........................................................................................................................................................ 21
System ..................................................................................................................................................... 22
Settings.............................................................................................................................................................. 22

4
Workflow Settings ......................................................................................................................................... 23
Order settings............................................................................................................................................ 23
Result Handling.......................................................................................................................................... 24
Device Settings .............................................................................................................................................. 25
Date and Time ........................................................................................................................................... 25
Language ................................................................................................................................................... 26
User Access Control................................................................................................................................... 26
Network Settings....................................................................................................................................... 29
Brightness & Sleep Mode.......................................................................................................................... 32
Delete Patient Info in All Records.............................................................................................................. 33
Maintenance ..................................................................................................................................................... 33
Virena Status ................................................................................................................................................. 34
LIS Status ....................................................................................................................................................... 34
Software / Test methods / Report Template................................................................................................. 35
Install software update.............................................................................................................................. 36
Manage methods ...................................................................................................................................... 36
Report template ........................................................................................................................................ 37
Event Log ....................................................................................................................................................... 37
Start New Test.......................................................................................................................................... 39
Starting New Test (Test Selection: Autofill Mode Off)...................................................................................... 39
Starting New Test (Test Selection: Autofill Mode On) ...................................................................................... 40
One Test Method Per Run.............................................................................................................................. 40
Procedure to Run Different Test Methods in the Same Batch....................................................................... 41
Assigning Sample Type and ID........................................................................................................................... 43
Auto Sample Order Off .................................................................................................................................. 43
Manual Entry of Patient Samples.............................................................................................................. 44
Barcode Entry of Patient Samples............................................................................................................. 44
Entry of Patient Samples When Using Virena ........................................................................................... 45
Correcting an Erroneous Sample ID Entry................................................................................................. 45
Auto Sample Order On................................................................................................................................... 45

5
QC Samples.................................................................................................................................................... 46
Manual Entry of Patient Samples.............................................................................................................. 46
Barcode Entry of Patient Samples............................................................................................................. 46
Entry of Patient Samples When Using Virena ........................................................................................... 46
Correcting an Erroneous Manual Sample ID Entry.................................................................................... 47
Correcting an Erroneous Barcoded Sample ID Entry................................................................................. 47
Test in Progress ................................................................................................................................................. 47
Sample Assignment or Editing Sample ID During the Run................................................................................ 48
LIS Orders................................................................................................................................................. 50
LIS Order Assignment........................................................................................................................................ 50
Review and Managing Results................................................................................................................... 53
View Results ...................................................................................................................................................... 53
Managing Results.............................................................................................................................................. 54
Shutdown................................................................................................................................................. 56
Maintenance and Cleaning........................................................................................................................ 57
Troubleshooting ....................................................................................................................................... 58
Technical Specifications ............................................................................................................................ 68
Mechanical Data and Hardware Features......................................................................................................... 68
Optics................................................................................................................................................................. 69
Power Requirements of the Instrument ........................................................................................................... 69
Accessories........................................................................................................................................................ 69
A symbols glossary can be found at quidel.com/glossary

6
General Information
Quidel Contact Information
Website quidel.com
If you have any questions regarding the use of this product, please contact Quidel Technical Support at
1.800.874.1517 (in the U.S.) or [e-mail]. If outside the U.S., further information can be
obtained from your distributor, or directly from Quidel at one of the numbers listed below. Reference
quidel.com to see more options for Support.
Country
Phone
E-Mail Address
Europe, Middle East and Africa
[phone] (main)
0 1800 200441 (toll free)
[e-mail]
Austria
[phone]
France
0 (805) 371674
Germany
[phone]
Netherlands
0 800 0224198
Switzerland
0 800 554864
United Kingdom
0 800 3688248
Italy
[phone]
North America, Asia-Pacific, Latin America
858.552.1100
[e-mail]
Canada
437.266.1704 (main)
888.415.8764 (toll free)
[e-mail]
China
0400 920 9366 or
[phone]
chinatechnicalser[email protected]m

7
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
Part 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.

8
Brief Warnings, Precautions and Limitations
NOTE: Within this document, text in bolded, purple-colored font indicates hyperlinks in the electronic
document. The word “Solana” is interchangeable with the word “instrument” or “device” throughout
this manual.
◼Always operate Solana on a surface that is level, dry, and stable, away from direct intense lighting.
◼Operation of Solana should occur at room temperatures between 15°C to 35°C.
◼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. Avoid spilling bleach in the well as this can cause
corrosion of the internal parts, which can cause failure of the instrument.
◼Maintenance and decontamination of workspace and equipment should follow and be performed
according to established laboratory protocols and schedules. Quidel does not require preventative
maintenance for the instrument as a requirement.
◼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. Should the Solana instrument need to be moved for bench-top cleaning,
please engage the transport lock prior to doing so. See Transport Lock section for details.
◼Plug the device into an approved, properly installed receptacle or Universal Power Supply.
◼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.

9
Potential Biohazard!
To reduce the risk of biohazard:
◼Treat specimens as potentially biohazardous material.
◼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 well-fitting 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.

10
Intended Use
Solana is a stand-alone 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.
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, label printer, saved on a USB flash drive, and/or sent to
a Laboratory Information System (LIS).
System Components
The following system components are included:
◼Solana instrument
◼Power supply and cords
◼Ethernet cord
◼Dymo LabelWriter 450 printer
◼Dymo LabelWriter 450 printer labels
◼Stylus
◼Workflow tray
◼Transport rack
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.