Procleix TIGRIS - Notices Regarding Samples; Reagent Notices

INTRODUCTION AND PRODUCT DESCRIPTION
PROCLEIX
®
TIGRIS System Operator’s Manual 1-5
Volume I: Operating the Instrument
Part # 902649EN Rev. A
Notices Regarding Samples
Reagent Notices
,
Caution: Mishandling samples may compromise assay results.
,
Caution: Do not run unapproved assay sample types on the PROCLEIX
®
TIGRIS System.
See the appropriate PROCLEIX
®
Assay package insert for allowable sample types.
,
Caution: Always handle specimens, calibrators, and PROCLEIX
®
TIGRIS Controls
cautiously and keep sample racks upright to prevent splashing or spilling.
,
Caution: Avoid touching the tops of specimens, calibrators, and PROCLEIX
®
TIGRIS
Controls during preparation and loading.
,
Caution: Processing a sample with less than the minimum sample volume can result in
errors (e.g., a Quantity Not Sufficient (QNS) error). The minimum sample volume includes
both the sample pipetting volume and the dead volume. For gel plasma separator tubes,
the minimum sample volume includes the sample pipetting volume and the buffer zone
volume.
,
Caution: Inspect all specimens, calibrators, and PROCLEIX
®
TIGRIS Controls for
undissolved particles, clots, foam, bubbles, or film. Do not attempt to use samples with
undissolved particles, clots, or foam on the system. Clots and foam may result in false level
sensing of liquid. An error message may not be generated. These conditions could
potentially cause an invalid run or a suspect bracket.
,
Caution: Use only the sample racks and sample tubes that are designed for use on the
PROCLEIX
®
TIGRIS System.
,
Caution: Ensure that all tubes are loaded straight and seated firmly in the sample rack.
Improperly loaded tubes may become unseated and pop out of the rack.
,
Caution: Do not place External Quality Controls (EQCs) in PROCLEIX
®
TIGRIS Control
positions.
,
Caution: Using sample barcodes with check digits is recommended to reduce the risk of
barcode misreads.
,
Caution: A misaligned or damaged barcode may cause system errors.
,
Caution: Handle all reagents, fluids, and solutions according to the instructions outlined in
this manual. Open reagents, fluids, and solutions carefully.
,
Caution: Do not use reagents or fluids that have exceeded their stability times or
expiration dates. Check the stability time and expiration date of all reagents prior to use.
,
Caution: The PROCLEIX
®
TIGRIS System software will not allow the use of any reagent
past the expiration date of the Master Lot, even if the individual expiration date has not yet
passed.
,
Caution: Inspect all packaged reagents, fluids, and consumables for damage before use.
Inspect Assay Reagents (ARs) for precipitate or foam. Avoid creating foam when handling
reagents. Do not use reagents with precipitate or foam.
,
Caution: Probe Reagents are photosensitive. Do not store Probe Reagents where they
could be exposed to direct light.
,
Caution: Do not load any reagents or other fluids into the PROCLEIX
®
TIGRIS System
that are not approved for use by Novartis Diagnostics.