CONTENTS 1. COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 2. WARNINGS AND PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 3. SYMBOLS AND ABBREVIATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 4. INTENDED USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 5. DOCK DESCRIPTION . . . . . . . . . . . . .
1. COMPONENTS The following items are supplied with the Silaris Dock. 1- Silaris Dock 1- AC Power Adaptor 1- AC Power Cord 1- Operator’s Guide 2. WARNINGS AND PRECAUTIONS • In Vitro Diagnostic Use Only • Do not block the air vents located on the rear and sides of the Silaris Dock. A minimum of 2 inches (5 cm) of clearance must be maintained. • Do not place the Silaris Dock in the vicinity of equipment that generates heat. Keep out of direct sunlight.
3. SYMBOLS AND ABBREVIATIONS The following symbols and abbreviations are used throughout the Operators Guide: AC – Alternating Electrical Current DC – Direct Electrical Current A – Amperes V – Electrical Voltage ~ SYMBOLS DEFINITION Alternating Current Direct Current Manufacturer MF Manufactured For IVD In Vitro Diagnostic Electronic equipment marked with this symbol should be disposed in electronic recycling waste. Biohazard – Potentially infectious materials. Precautions must be observed.
6. SPECIFICATIONS 6.1. DOCK POWER INPUT 12VDC ± 1VDC, 1A maximum OPERATING ENVIRONMENT Ambient Temperature: 15°C to 30°C (59 to 86°F) Relative Humidity: 20%-80%, non-condensing Altitude: Sea level to 8,000 feet DIMENSIONS 5.7 in (14.5 cm) H x 3.9 in (9.9 cm) W x 3.8 in (9.7 cm) D TOTAL WEIGHT (Dock, Power Supply, and Power Adaptor) < 1.4 lbs (619 g) ACCEPTIBLE TILT The Dock must be installed on a level surface, with an incline not to exceed 10 degrees.
7.1 EXTERIOR CLEANING PROCEDURE Cleaning of the exterior surfaces of the Silaris Dock and the immediate work area should be performed as necessary, no less than daily when in use. 1. 2. 3. 4. 5. 6. 7. 8. Unplug the power cord from the wall outlet and Dock. Close the Dock lid. Using a cleaning solution (10% bleach or 70% ethanol), or a germicidal disposable wipe (such as CaviWipes™), gently wipe the outer surfaces of the Dock, removing any debris.
.3 SHIPPING RETURN PROCEDURE Cleaning of the Silaris Dock must be completed prior to the return to Sekisui Diagnostics. Cleaning must be completed according the instructions provided. Please complete the information below and attach the completed record to the dock prior to return. Please complete the cleaning procedure following the instructions below: 1. 2. 3. 4. 5. 6. 7. Unplug the power cord from the wall outlet and Dock. Close the Dock lid.
. DOCK SET-UP Do not block the air vents located on the rear and sides of the Silaris Dock. A minimum of 2 inches (5 cm) of clearance must be maintained. Do not place the Silaris Dock in the vicinity of equipment that generates heat. Keep out of direct sunlight. The Dock must be maintained in an ambient temperature range of 15°C to 30°C (59 to 86°F) to operate properly. Place the Silaris Dock on a level, stable table or laboratory bench.
. DOCK OPERATION This section provides detailed instruction pertaining to the operation of the Silaris Dock only. It is not intended to be a comprehensive instruction for performing diagnostic tests. Such instructions are found packaged with the specific Silaris Test Kits. The Silaris Dock is capable of running a number of Silaris Tests. For the purpose of illustration, this section includes Dock messages specific to the Silaris Influenza A&B Test.
9.2. RUNNING THE TEST Per the test kit instructions, remove the foil tab from the Test Cassette. Immediately add the sample to the cassette sample port. The Silaris Dock will beep upon sensing the sample, and display “SAMPLE LOADED CLOSE LID.” SAMPLE LOADED CLOSE LID Close the lid, pressing it into place over the top of the Test Cassette until it clicks into its locked position. SAMPLE LOADED LID CLOSED NOTE: The Dock will beep once every second until the lid is closed.
9.2. RUNNING THE TEST Once the Test Cassette has been removed, the Dock will display the number of tests that have been run and the number remaining. NOTE: If fewer than 100 tests remain, the Silaris Dock will beep three times, and the display will remind the user to replace the unit. After a few seconds, the Dock will display “DOCK READY INSERT CASSETTE.” This indicates that the Silaris Dock is ready to run additional cassette if needed.
. TROUBLESHOOTING The Silaris Dock performs a number of different environmental tests before and during an assay run to ensure that the conditions will allow a successful assay. If any of these tests fail, an error code is displayed along with a brief notification of the type of failure. For example, if the Dock detects that a used Test Cassette has been inserted, an error code will be displayed for several seconds. This screen will be followed by a brief message describing the error.
12. TROUBLESHOOTING Error Code Displayed Error Description 06 CASS. NOT SEATED PROPERLY. RESEAT 07 TEST ABORTED! CASSETTE REMOVED INADEQUATE SAMPLE 08 09 REMOVE UNATTENDED CASS. 10 CASSETTE SEAL FAILED. REPLACE 11 DOCK EXPIRED REPLACE DOCK 12 TEST ABORTED! TILT ERROR!! 13 TEST ABORTED! POWER IS LOW 14 TEST ABORTED! FAN/COOLING FAIL 15 TEST ABORTED! FLOW ERROR Cause/Requested Actions When inserting the Test Cassette into the Dock, it must be pressed firmly into place.
APPENDIX 1: SHIPPING RETURN PROCEDURE Cleaning of the Silaris Dock must be completed prior to the return to Sekisui Diagnostics. Cleaning must be completed according the instructions provided. Please complete the information below and attach the completed record to the dock prior to return. Please complete the cleaning procedure following the instructions below: 8. Unplug the power cord from the wall outlet and Dock. 9. Close the Dock lid. 10.
MF Sekisui Diagnostics, LLC 6659 Top Gun Street San Diego, CA 92121, USA Tel: (781) 652-7800 www.sekisuidiagnostics.com Mesa Biotech, INC. 6190 Cornerstone Court East Suite 200 San Diego, CA 92121, USA www.mesabiotech.com M © 2018 Sekisui Diagnostics, LLC. All rights reserved. Silaris® is a registered U.S. trademark of Sekisui Diagnostics, LLC. Because every result matters™ is a trademark of Sekisui Diagnostics, LLC.