Consumables Notices; Limitations - Procleix TIGRIS Operator's Manual

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Consumables Notices

Caution: Do not apply excessive force to the MTU waste bag while handling. If
mishandling occurs, inspect the waste bag for puncturing, remove any protruding tips while
following Universal Precautions, and place the entire bag and contents into a new bag.
Caution: Press bag down firmly against sides of the MTU Waste Container to ensure that
there are not wrinkles or air pockets that might catch an MTU as it is discarded.
Caution: Make sure that the Tiplet Waste Bag is flat against the sides of the container so
that the sensors will recognize the presence of the bag when the door is closed.
Caution: Do not re-use pipette tips, Multi-Tube Units (MTUs), or MTU Tiplets. Use only
tips, MTUs, MTU Waste Covers and MTU Waste Deflectors that are supplied by Novartis
Diagnostics. Use of unapproved consumables may compromise assay or analyzer
performance.
Caution: Avoid touching the tops or bottoms of pipette tips.
Caution: Load only full pipette tip trays. Do not insert individual pipette tips into the trays.
The system tracks which tip positions it has used and will not use individually inserted tips.
Caution: Use the cardboard box to load MTUs. Do not touch individual MTUs or MTU
Tiplets or load them individually by hand.
Caution: Do not switch the caps or bottle positions of the two liquid waste containers.
Replace each container in the proper position with its appropriate cap.

Limitations

♦
The sample barcodes are not tracked between multiple PROCLEIX
♦ The positive specimen test algorithm is not performed automatically at the PROCLEIX TIGRIS
System level. See the appropriate PROCLEIX Assay package insert for further instructions.
♦ The positive pool resolution is not automatically performed at the PROCLEIX TIGRIS System
level. See the appropriate PROCLEIX Assay package insert for further instructions.
♦ It is the responsibility of each user to assure that the LIS data transfer is properly validated
with the LIS system at each site.
♦ The last line of the LIS export file contains a Cyclic Redundancy Checksum (CRC) tag that can
be used in a computer program to verify the file contents. Novartis Diagnostics Technical
Service can provide instructions to LIS programmers on verification of the CRC tag.
♦
Results verification subsequent to LIS transmission is the responsibility of each user to
properly validate.
♦
The performance of the PROCLEIX TIGRIS System has not been determined for altitudes
above 7355 feet (2242 m).
♦
The PROCLEIX TIGRIS System has not been validated to run on a network domain. It must
not be configured to log on to a network domain. Contact Novartis Diagnostics Technical
Service for more information about network configuration.
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Part # 902649EN Rev. A
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TIGRIS Systems.
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PROCLEIX TIGRIS System Operator's Manual
Volume I: Operating the Instrument