Operational Notices - Procleix TIGRIS Operator's Manual

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Operational Notices

Warning: Only properly trained personnel should operate the PROCLEIX
System.
Caution: Do not remove the covers. Only Novartis Diagnostics authorized personnel may
remove the covers of the PROCLEIX
Caution: Do not modify the PROCLEIX
Novartis Diagnostics authorized personnel may change the system. Do not add
accessories, or use supplies, including MTU Waste bags, or reagents that are not
authorized by Novartis Diagnostics.
Caution: To ensure accurate test results, follow all instructions in the appropriate
PROCLEIX assay package insert for use on the PROCLEIX
Caution: Follow the instructions in the operator's manual, on software screens, and in the
appropriate PROCLEIX Assay package insert for safe and effective use of the PROCLEIX
TIGRIS System.
Caution: Do not force a door open. Equipment doors will lock during operation.
Caution: Open the Waste Door fully before opening the Waste Drawer.
Caution: Do not shut off power to the CPU while the system is restarting or running.
Caution: Do not handle fluids over keyboard and related computer equipment as spills
may damage the system, thereby preventing operation and causing malfunction.
Caution: The operator must visually check the vacuum level of the PROCLEIX
System when loading the Target Capture Reagent to ensure that the system is operating
with a vacuum level that meets the requirements in "Vacuum Pressure Requirements" on
page 1-22. Contact a Novartis Diagnostics Technical Service Representative for assistance
if it does not.
Caution: Two primes are required if the instrument has not been used for three or more
days.
Caution: To prevent contamination or misalignment, avoid touching the Amplification and
HPA Pipettors when removing the AR Carousel and/or Cover.
Caution: The interpretation on the run report will not change for a specimen flagged with a
reject reason code. The Flags column must be carefully reviewed to identify specimens
with reject reason codes.
Caution: Do not include the Start/Stop characters (if present) when manually entering a
Sample ID – doing so will create a mismatch between the actual Sample ID and the ID on
the printed report.
Caution: DO NOT shut down the system using the computer power button—doing so may
cause unnecessary errors and possible database corruption.
Caution: Before closing the MTU Drawer, ensure that there is a gap between the last MTU
and the end of the drawer. Do not overload the MTU Drawer.
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Part # 902649EN Rev. A
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TIGRIS System.
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TIGRIS System hardware or software. Only
PROCLEIX
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TIGRIS System.
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TIGRIS System Operator's Manual
Volume I: Operating the Instrument
®
TIGRIS
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®
TIGRIS