mesabiotech Accula Dock Manual

Accula™ Dock
Operator’s Guide
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Mesa Biotech, Inc.
Customer Support
6190 Cornerstone Court East, Suite 220
San Diego, CA 92121
858-800-4929
I. Contact Information
MManufacturer
Mesa Biotech, Inc.
Customer Support
6190 Cornerstone Court East,
Suite 220
San Diego, CA 92121
858-800-4929
yEU Authorized Representative
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Distribution For a complete listing of distributors, contact
Mesa Biotech, Inc. or visit www.mesabiotech.
com/distributors
II. Warranty
Mesa Biotech™ warrants that Accula™ Docks purchased through Mesa Biotech or from an authorized
distributor shall be free from defects in material and workmanship for a period of one year from the date
of purchase or 1,500 tests, whichever comes first.The warranty shall not extend beyond 3 years from the
date of shipment to an authorized distributor.Misuse of the Accula™ Dock, including exposure to harmful
chemicals, environmental extremes beyond the equipment ratings in this Guide, or mishandling may render
the warranty null and void.
Ill. Intended Use
The Accula Dock is a reusable platform, used in conjunction with an Accula Test Cassette to run in vitro
diagnostics assays.
C V
61010
Preface
© Copyright 2016, Mesa Biotech, Inc. All rights reserved. The information contained in this document may
be subject to change without notice. Neither this document, nor any part therein, may be reproduced in any
form or by any means, without the express written permission of Mesa Biotech, Inc.
Any questions regarding the contents of this Operator’s Guide may be directed to the address below, or to
your local Mesa Biotech representative.
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lV. Trademarks and Patents
This product may be covered by one or more U.S. and/or foreign patents or pending patent applications.
See www.mesabiotech.com/patents for details.
KimWipe™ is a trademark of Kimberly Clark Corporation.
CaviWipes ™ is a trademark of Metrex Research, LLC.
V. Symbols and Abbreviations
The following symbols are used throughout this manual:
Symbol Denition
~Alternating Current
Direct Current
MManufacturer
yAuthorized representative in the European Community.
N WEEE – Electronic equipment marked with this symbol are subject to European Union Directive
2002/96/EC (WEEE), and cannot be disposed of in the municipal waste system.
FBiohazard – Potentially infectious materials. Precautions must be observed.
YConsult the instructions for use for important cautionary information such as warnings and precautions
that cannot, for a variety of reasons, be presented on the medical device itself
VFor In Vitro Diagnostic Use
Informational note.
The following symbols are used throughout this manual:
AC – Alternating Electrical Current
DC – Direct Electrical Current
A – Amperes
V – Electrical Voltage
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VI. Warnings and Precautions
YDo not block the air vents located on the rear and sides of the Accula™ Dock. A minimum
of 2 inches (5 cm) of clearance must be maintained.
YDo not place the Accula™ Dock in the vicinity of equipment that generates heat. The Dock
must be maintained in an ambient temperature range of 15°C to 30°C (59 to 86°F) to
operate properly.
YTo reduce the risk of damage to the unit, avoid use of sprays in the vicinity of the
Accula™Dock.
YUse only the supplied power adapter with the Accula™ Dock (MeanWell Part Number
GSM25B12-P1J). This component has been tested and certified for use. If a replacement
power supply is needed, please contact your Mesa Biotech distributor.
VII. Disposal and Shipping
All electronic products must be disposed of separately from the municipal waste system.
FA used Accula™ Dock may be biologically contaminated. Prior to disposal, or shipping for
service, the Dock must be thoroughly cleaned.
NThe Accula™ Dock is covered under European Directive 2002/96/EC (WEEE), and must
therefore be disposed of at collection facilities designated by government or local
authorities. For more information regarding disposal of the Dock, please contact your
Mesa Biotech distributor.
To decontaminate the Dock prior to disposal:
1. Unplug the DC power connector from the back of the Accula™ Dock.
2. Open the lid of the Dock by depressing the lid latch button and pulling the lid to the open position.
3. If there is a Cassette inserted into the Dock, remove it by firmly grasping and pulling it upward.
4. Soak the entire Dock in a 10% bleach solution for at least 10 minutes. Ensure that the Dock is fully
submerged in the solution, and that the entire interior of the Dock is flooded. It is recommended to
maintain an upright orientation of the Dock in order to allow entrapped air to escape through the
cassette slot.
5. Remove the Dock from the bleach solution. Turn the Dock upside down to drain the solution from the
interior. Allow the Dock to dry.
6. Dispose of the Dock as electronic waste in accordance to local regulations.
If for any reason, it becomes necessary to return a Dock to Mesa Biotech or one of its distributors, prior
to packaging please carefully follow the exterior cleaning procedure detailed in section D. Maintenance,
Cleaning the Accula™ Dock.
A. System Description and Specications
The Accula™ Dock is an electronic module which executes in vitro diagnostic tests on compatible Accula
Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all
electrical systems, controls and logic necessary to orchestrate in vitro diagnostic tests within the inserted
Test Cassette.
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Upon insertion of a Cassette, the Dock will detect and identify the Cassette type. After the user transfers
a clinical test sample into the Test Cassette and closes the Dock lid, embedded firmware in the Dock will
control fluid flow of the sample into the various chambers of the Test Cassette, apply controlled voltage
signals to the various Cassette heaters (monitored by sensors within the Dock), and provide visual status
to the user with critical information such as estimated time to read, and various error states, should they
beencountered.
Dock Specications
• Power input: 12VDC ± 1VDC, 1A maximum
• Environmental (operating temp, altitude, humidity)
° Ambient Temperature: 15°C to 30°C (59 to 86°F)
° Relative Humidity: 20%-80%, non-condensing
° Altitude: Sea level to 8,000 feet
The Accula™Dock is not to be used in direct sunlight.
• Acceptable tilt – The Dock must be installed on a level surface, with an incline not to exceed
10degrees.
• Dimensions: 5.7 in (14.5 cm) H x 3.9 in (9.9 cm) W x 3.8 in (9.7 cm) D
• Weight (including Dock, Power Adapter, and US Power Cord: < 1.4 lbs (619 g)
• Useful life: 3,000 tests.
AC Adapter Specications
Power input: 100-240VAC, 50/60Hz
Power Output: 12VDC, 2.08A, 25W maximum
Y
Use only power cords provided by Mesa Biotech type H03VVH2-F, 2 x 0.75mm² or type SPT-
2, 2 x 18AWG, 60°C, with connector type C7 and approved plugs from EU, US, Canada, and
other countries as may be applicable.
B. Installation
YDo not block the air vents located on the rear and sides of the Dock. A minimum 2 inches (5
cm) of clearance must be maintained.
YDo not place the Dock in the vicinity of equipment that generates heat. The Dock must
be maintained in an ambient temperature range of 15°C to 30°C (59 to 86°F) to operate
properly.
1. Place the Accula™ Dock on a level, stable table or laboratory bench. To ensure proper function, allow
at least 2 inches (5 cm) of clearance around the Dock. Do not place it near equipment that will give
offheat.
2. Insert the round DC connector of the adapter into the Dock as shown below. Connect the power cord
to the AC adapter, and then insert the power cord plug into the electrical outlet.
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This system does not use a ground connection. Depending on your type of AC outlet,
there may be an unused ground pin showing. This is normal and expected.
3. Once the Accula™ Dock is connected to power, it will initialize automatically. The unit will beep,
followed by a series of brief messages on the display. (The image below is for illustration purposes
only. Your firmware P/N, version, and ambient temperature may differ)
Immediately after displaying the final message, the unit will beep twice, which indicates that the Dock is
ready to use.
C. Operation
This section provides detailed instruction pertaining to the operation of the Accula™ Dock only. It is not
intended to be a comprehensive instruction for performing diagnostic tests. Such instructions are found
packaged with the specific test kits.
The Accula™ Dock is capable of running any of a number of in vitro diagnostic tests offered by Mesa
Biotech. For the purpose of illustration, this section includes Dock messages specific to the Flu A/Flu B Test.
Inserting the Test Cassette
Each Test Cassette may only be used once. Sensors in the Dock will not allow the assay to
run if the cassette has already been inserted.
1. Remove the Test Cassette from the foil pouch by tearing off the top of the pouch starting at the
notches in the pouch.
2. Open the lid of the Dock by depressing the black lid latch button and pulling the lid to the
openposition.
3. Insert the Test Cassette into the slot with the cassette label facing toward the front of the Dock. The
sample port (covered with a foil tab) on the top of the cassette should be accessible to the user. Fully
depress the Test Cassette into the Dock until it ‘clicks’ into position. The Accula™ Dock will measure
the temperature of the cassette and display it as shown in the example below:
CASSETTE
TEMPERATURE: 24C
FIRMWARE
P/N 210405 V2.7
AMBIENT
TEMPERATURE: 25C
DOCK READY
INSERT CASSETTE
MESA BIOTECH, INC.
MOLECULAR POC
1.
2.
3.
4.
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If the cassette has been properly inserted, the display will identify the type of test that is supported by
the cassette, for example:
FLU A/FLU B
CASS. INSERTED
If the display shows an error, refer to Section
E - Troubleshooting for additional information.
4. After a few seconds the display will prompt the user to add the sample to the cassette sample port:
ADD SAMPLE
THEN CLOSE LID
The Test cassette is now ready to accept the sample.
To avoid contamination, do not remove the foil tab
covering the cassette sample port until you are ready to add the sample.
Running the Assay
After starting the test, avoid bumping, tilting, or otherwise disturbing the Accula™
Dock, as this may cause the test to abort.
1. Per the test kit instructions, remove the foil tab from the Test cassette and immediately add the sample
to the cassette sample port. The Accula™ Dock will beep upon sensing the sample, and display:
SAMPLE LOADED
CLOSE LID
The Dock will then beep once every second until the lid is closed.
2. Close the lid, pressing it into place over the top of the Test Cassette until it clicks into its locked
position. The Dock will then display:
SAMPLE LOADED
LID CLOSED
The Dock will verify that the Test Cassette has been sealed. Once verified it will initiate the test
anddisplay:
CASSETTE SEALED
TEST STARTED
During the test, the Dock will display an estimated time to completion. For example:
TEST RUNNING
REMAINING: 25:15
The remaining time is an estimate of the time required to run the assay. The actual time
remaining is determined by a number of factors, including ambient temperature, altitude,
and the type of assay being run.
During a test run, you will hear the whir of a fan and flow of air through the Dock. This is
perfectly normal behavior, and is not indicative of a Dock malfunction.
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3. Allow the assay to run to completion before moving or disturbing the Accula™ Dock. The internal fan
will turn on periodically during the assay. This is normal and expected. When the assay is finished, the
remaining time will be 00:00, and the Accula™ Dock will display:
TEST COMPLETE
READ RESULTS
4. The Dock will beep every two seconds until the Test Cassette is removed.
5. Remove the Test Cassette by pressing the latch button and pulling the lid open. Firmly grasp the top
of the Test Cassette and pull straight up until the Test Cassette is removed from the Dock. The results
of the assay may be immediately read. For instructions interpreting results, please refer to the test kit
instructions.
Once the Test Cassette has been removed, the Dock will display the number of tests that have been
run and the number remaining. For example:
RUN COUNT: 1113
REMAINING: 1887
6. If fewer than 100 tests remain, the Accula™ Dock will beep three times, and the display will remind
the user to replace the unit. For example:”
REPLACE DOCK
IN 56 TESTS
7. After a few seconds, the Dock will display:
DOCK READY
INSERT CASSETTE
8. This indicates that the Accula™ Dock is ready to run another assay.
Reading the Test Results
Please refer to instructions provided with each assay test kit.
Re-programming the Dock
Periodically new tests are developed which require new programming for the Accula™ Dock. In order to
support these new tests, the Dock firmware must be updated. This is a very simple process, by following
these easy steps:
1. Apply power to the Accula™ Dock as indicated in Section B – Installation. The Dock will automatically
initialize and display:
DOCK READY
INSERT CASSETTE
2. Insert the latest Programming Cassette (denoted by red top) into the Dock as instructed in Section C
above (Inserting the test cassette). The Dock will sense the Programming Cassette and display:
PROGRAMMING
CASSETTE READY
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Followed by:
PROGRAMMING
WAIT FOR REBOOT
3. The Dock’s display will turn off for a few seconds while the unit reboots and reprograms its embedded
firmware. Once the display turns on, verify that the new firmware revision is correctly reported. (The
image below is for illustration purposes only. Your firmware P/N and version may differ):
FIRMWAREP/N
210438-EN REV A
4. The display will prompt you to remove the Programming Cassette:
REMOVE PROGRAM-
MING CASSETTE
Once the Programming Cassette is removed, the Accula™ Dock will restart with the new
firmwareinstalled.
D. Maintenance
Cleaning the Accula™ Dock
Regular cleaning of the Accula™ Dock is recommended. The Dock should be cleaned every day that it is
used, and prior to disposal or shipment or servicing.
FA used Dock may be biologically contaminated. Prior to disposal, or shipping for service, the
Dock must be thoroughly cleaned.
YTo reduce the risk of damage to the unit, avoid use of sprays in the vicinity of the Dock.
YPrior to cleaning the Accula™Dock, disconnect the power supply. This will help to prevent
damage to the unit.
Mesa Biotech recommends cleaning the Dock each day it is used with CaviWipes™ germicidal disposable
wipes, (EPA Registration No: 46781-8). The cleaning procedure below has been validated using these wipes.
CaviWipes™ germicidal disposable wipes contain the following active ingredients:
• Isopropanol: 17.2% and
• Diisobutyl-phenoxy-ethoxyethyl dimethyl benzyl ammonium
chloride: 0.28%.
For information on purchasing CaviWipes™ germicidal wipes, contact your authorized distributor.
If Cavi Wipes are unavailable, other cleaning solutions may be used such as 10% bleach, or 70% ethanol.
Procedure:
1. Unplug the power cord from the Dock.
2. Close the Dock lid.
3. Using a CaviWipes™ germicidal disposable wipe, gently wipe the outer surfaces of the Dock, removing
any gross debris. Do not press the wipe against the open vents of the back or sides of theDock.
4. Using a new CaviWipe, wipe the front of the Dock twice top to bottom, then twice left to right. Follow
this procedure for the back, top and bottom of the Dock.
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5. Do not let liquid accumulate near any opening. Make sure no liquid enters the dock.
6. Leave the Dock “wet” for at least 3 minutes.
7. With a fresh dry cloth (like a Kimwipe™) remove any residual moisture.
8. Allow the unit to dry for at least 10 minutes prior to re-connecting the power cord for the AC Adapter.
YDo not open the Dock lid during the cleaning procedure.
YDo not insert the cleaning wipe into the cassette slot. This may cause damage to the unit.
YDo not use solvents other than those recommended above.
YDo not let liquid accumulate in or around Dock vents.
YEnsure that the Dock lid is closed prior to cleaning.
Troubleshooting
The Accula™ 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:
ERROR! CODE 05
This screen will be followed by a brief message describing the error:
CASSETTE ALREADY
USED! REPLACE!
Listed below are the different error codes with an explanation of the causes and remedies for each.
Error
Code Displayed Error Description Cause/Remedy
01 ALTITUDE OUT OF
VALID RANGE
The maximum operational altitude is 8000 feet (2438 meters) above sea level. The Dock will check the altitude on its
initial power up and not continue if the altitude range has been exceeded. To continue, the Dock must be re-located to an
altitude below 8000 feet.
02 TEMPERATURE OUT
OF VALID RANGE
DOCK: The valid ambient operating temperature range of the Dock is 59-86°F (15 – 30°C). This is checked during power
up and whenever the Dock is reset. Move the Dock to an acceptable ambient temperature environment and let it sit for at
least 5 minutes to acclimate.
03 TEMPERATURE OUT
OF VALID RANGE
CASSETTE: The valid operating temperature range of the Test Cassette is 59-86°F (15 – 30°C). This is checked as
soon as a Test Cassette is inserted into the Dock. Insure that the Test Cassette temperature is valid, and re-insert it into
theDock.
04 UNKNOWN TYPE
OF CASSETTE
This error is caused when the Test Cassette is not recognized by the Dock. The most likely reason for this would be that
the latest program revision has not been installed into the Dock. See section C: Operation, Re-programming the Dock
above.
It is also possible that the Test Cassette is not firmly seated into the Dock. In this case, remove the Test Cassette, wait a
couple of seconds, and re-insert it, pressing it firmly into position.
05 CASSETTE ALREADY
USED! REPLACE!
Each Test Cassette may only be used one time. Even if a test does not complete, that Test Cassette may not be used again
if the previous test was started or if the lid was closed.
06 CASS. NOT SEATED
PROPERLY. RESEAT
When inserting the Test Cassette into the Dock, it must be pressed firmly into place. If this error occurs, remove the Test
Cassette, wait a couple of seconds, and re-insert it, ensuring that the Test Cassette has come to a firm stop. If this error
continues after trying multiple Test Cassettes, contact your distributor to replace the Dock.
07 TEST ABORTED!
CASSETTE REMOVED
This error occurs when a Test Cassette has been removed before the assay test has been completed. To avoid this error
and guarantee accurate testing, the Test Cassette must not be removed until the test is complete. See section C. Running
the Assay above.
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Accula™ Dock Operator’s Guide US IVD
60058-A 10
Error
Code Displayed Error Description Cause/Remedy
08 INADEQUATE
SAMPLE
This error will occur if the lid is closed before the sample is loaded into the Test Cassette. To avoid this error, never close
the lid before sample addition. If a sample was added but not detected, discard that Test Cassette and insert a new Test
Cassette. Ensure the sample is at room temperature. Ensure sufficient sample volume is added to the Test Cassette.
09 REMOVE
UNATTENDED CASS.
Each Test Cassette must be used in a timely manner when removed from its protective pouch. If the Test Cassette has
been sitting in the Dock for more than 5 minutes, the test will abort and the Test Cassette must be discarded.
10 CASSETTE SEAL
FAILED. REPLACE
If this error occurs, replace the Test Cassette and run the test again. If this failure repeats, contact your distributor and
replace the Dock.
11 DOCK EXPIRED
REPLACE DOCK When the Dock has completed 1500 runs, this error will appear. Contact your distributor to purchase a replacement Dock.
12 TEST ABORTED!
TILT ERROR!!
The Dock must be kept level at all times when operating. Do not bump, lift, or tilt the Dock during operation. If this error
occurs the test is aborted and must be re-run with a new Test Cassette.
13 TEST ABORTED!
POWER IS LOW
The Dock’s power supply voltage has fallen below acceptable limits. The run is aborted and another run is not allowed to
start until the power supply voltage is within acceptable limts.
14 TEST ABORTED!
FAN/COOLING FAIL
The Dock is not temperature cycling as expected. This may be caused by a fan malfunction, or a problem with the liquid
flow inside the Test Cassette. The run is aborted and must be re-run with a new Test Cassette. If this error happens
repeatedly, the Dock must be replaced.
15 TEST ABORTED!
FLOW ERROR
The Dock is not heating properly during temperature cycling. This is indicative of a problem inside the Test Cassette with
fluid flow.The test is aborted and must be re-run with a new Test Cassette.
Other Warnings:
The following messages are informational, and do not indicate an error in the Dock or test.
CLOSE LID
REMAINING: 21:15
While opening the lid during a test will not pause or abort the test, it is not recommended. If this warning
occurs, close the lid and let it remain closed until the completion of the test.
REPLACE DOCK
IN 99 TESTS
When 100 or fewer tests of the recommended life time usage of 1500 tests remain, this warning will be
displayed after every completed test. Contact your distributor to purchase a new Dock before this number
approaches zero.
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