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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Operator’s Guide
2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Undiluted Bleach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Bleach Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Sodium Hydroxide Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Lowering the Thermal Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-24
Raising the Thermal Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-25
Cleaning All Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-31
Cleaning Bad Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-32
Removing and Installing Cuvette Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-33
Cleaning the Sample Probe and Drain . . . . . . . . . . . . . . . . . . . . . . . . . . 7-38
Replacing AC Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-52
Replacing DC Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-54
Alignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
General Alignment Information . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Alignment Offsets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Printing and Viewing Alignment Offsets . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Barcode Scanner Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Cuvette Ring Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
HM Module Alignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Aligning the Incubate Wheel to the Transfer Opening . . . . . . . . . . . . . 8-8
Aligning the Wash Wheel to the Incubate Wheel . . . . . . . . . . . . . . . . . 8-9
Aligning the Wash Probes to the Wash Wheel . . . . . . . . . . . . . . . . . . . 8-10
Aligning the Vessel Transfer Shuttle to the Incubate Wheel . . . . . . . . 8-11
Aligning the Vessel Transfer Shuttle to the Wash Wheel . . . . . . . . . . . 8-13
Aligning the Vessel Transfer Shuttle to Load . . . . . . . . . . . . . . . . . . . . 8-14
LOCI® Arm Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16
LOCI® Arm to Vessel Alignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16
LOCI® Arm to Detector Alignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17
Photometer Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19
R1 Reagent Probe Alignments . . . . . . . . . . . . . . . . . . . . . . . . . 8-20
R1 Reagent Arm to Drain Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-21
R1 Reagent Arm to Target (Cuvette) Alignment . . . . . . . . . . . . . . . . . . 8-22
R1 Reagent Arm to Reagent Tray Alignment . . . . . . . . . . . . . . . . . . . . . 8-24
R2 Reagent Probe Alignments . . . . . . . . . . . . . . . . . . . . . . . . . 8-25
R2 Reagent Arm to Drain Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-26
If a Coarse Adjustment (R2 Home Flag) is Needed . . . . . . . . . . . . . . . . . . . . . . . . . . 8-27
R2 Reagent Arm to Target (Cuvette) Alignment . . . . . . . . . . . . . . . . . . 8-28
R2 Reagent Arm to Reagent Tray Alignment . . . . . . . . . . . . . . . . . . . . . 8-29
2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Troubleshooting Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Help Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Specifying the Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Solving the Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
When You Call Us . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Remote Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Remote Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Chemistry Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
When to Troubleshoot Chemistry Problems . . . . . . . . . . . . . . . . . . . . . 9-6
How to Troubleshoot Chemistry Problems . . . . . . . . . . . . . . . . . . . . . . 9-6
One or more QC results are out of range. . . . . . . . . . . . . . . . . . . . . . . . 9-7
Inaccuracy—Result Obtained is Inconsistent With Patient History. . . . 9-7
Imprecision—Test Results are Not Reproducible. . . . . . . . . . . . . . . . . . 9-8
Printing Filter Data for a Test Result . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
System Check Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Resolving Miscellaneous System Check Error Conditions . . . . . . . . . . . 9-9
Asterisks Appear Next to a System Check Result . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Asterisks Appear instead of Max Diff, Mean, and SD Calculations . . . . . . . . . . . . . . 9-9
Probe Cleaner Failed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
No System Check Printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Unacceptable Photometer Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
Unacceptable Mean or SD for a Reagent Arm (R1, R2) . . . . . . . . . . . . . 9-10
To Enter a New ABS/CHK Carton Value: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11
Unacceptable Mean or SD for the Sampler . . . . . . . . . . . . . . . . . . . . . . 9-11
Unacceptable Mean or SD for the HM Wash System . . . . . . . . . . . . . . . 9-12
Unacceptable LOCI® Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14
Active System Errors Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14
Error Log Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-15
Software Error Troubleshooting Help . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16
IMT Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17
IMT Results Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17
For Na, K, or Cl results: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17
IMT Error Message Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17
Acceptable IMT values: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17
Customizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Selecting Instrument Options . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Select/Change an Instrument Option . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
System Configuration Menu Screen Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
CHK Flex Reagent Cartridge Information . . . . . . . . . . . . . . . . . 11-2
Calibration (or Verification) Setup Flow Chart . . . . . . . . . . . . . 11-3
Calibration (or Verification) Review Flow Chart . . . . . . . . . . . . 11-4
Help Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Operating Conditions Status Area Icons . . . . . . . . . . . . . . . . . . 11-6
Reagent Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
Cuvette Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7
UPS (Uninterruptible Power Source) . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7
Vessel Feeder Empty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8
Cuvette Film Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8
Reagent Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8
Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
Short Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
Check Needs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
Alarm Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10
Clot Check Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10
Keystroke Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-11
Operating Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12
Test Report Messages and Reference Range Indicators . . . . . . 11-13
Test Results with Test Report Messages . . . . . . . . . . . . . . . . . . . . . . . . 11-13
Test Results with Reference Range Indicators . . . . . . . . . . . . . . . . . . . . 11-13
Understanding Test Report Messages . . . . . . . . . . . . . . . . . . . 11-14
Abnormal Assay (abnl assay) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
HA1C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
Abnormal Reaction (abnl reaction) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15
Aborted Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15
Absorbance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15
Above Assay Range (above asy rng) . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-16
Antigen Excess (antign excess) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-16
Arithmetic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-16
Assay Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-16
Assay Range Diluted (assy rng/dilu) . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-17
Below Assay Range (below asy rng) . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-18
Calibration Expired (calib’n exp’d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-18
ClotCheck Err . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-18
Diluted. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-19
Hemoglobin (TBI and DBI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-19
Hemoglobin (TBIL and DBIL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-19
HI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-20
High ‘A’ Error (hig ‘A’ err) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-20
2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide About this Guide
This chapter describes the contents of the guide as well as manual review
forms and maintenance logs.
2011/09 1-1
About this Guide Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Intended Use
The Dimension® EXL™ with LM system and Dimension® EXL™ 200 system are in
vitro diagnostic devices that are intended to measure a variety of analytes in
human body fluids. The systems utilize photometric, turbidimetric,
chemiluminescence and integrated ion selective multisensor technology for
chemical and immunochemical applications for clinical use.
1-2 2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide About this Guide
2011/09 1-3
About this Guide Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Chapter Contains
4: Setup and Supplies Procedures for daily setup and meeting system
needs on the Dimension® EXL ™ system.
6: Calibration and Quality Control Procedures for reagent calibration and quality
control on the Dimension® EXL ™ system.
1-4 2011/09
Manual Review Documentation
Review Date Adopted Revised Title of Reviewer Reviewer Signature Notes
Use the notes column to document all revisions made to a method and/or any method revision levels sent by manufacturer.
Manuals must be reviewed by supervisor/lab manager at a minimum frequency of once per year per CLSI/NCCLS GP2-A5 guidelines.
Review Date Adopted Revised Title of Reviewer Reviewer Signature Notes
Use the notes column to document all revisions made to a method and/or any method revision levels sent by manufacturer.
Manuals must be reviewed by supervisor/lab manager at a minimum frequency of once per year per CLSI/NCCLS GP2-A5 guidelines.
Review Date Adopted Revised Title of Reviewer Reviewer Signature Notes
Use the notes column to document all revisions made to a method and/or any method revision levels sent by manufacturer.
Manuals must be reviewed by supervisor/lab manager at a minimum frequency of once per year per CLSI/NCCLS GP2-A5 guidelines.
Review Date Adopted Revised Title of Reviewer Reviewer Signature Notes
Use the notes column to document all revisions made to a method and/or any method revision levels sent by manufacturer.
Manuals must be reviewed by supervisor/lab manager at a minimum frequency of once per year per CLSI/NCCLS GP2-A5 guidelines.
Dimension® EXL ™ with LM and Dimension® EXL ™ 200
integrated chemistry system
ATTENTION!
Do Not Mark on these log sheets.
Use them as Masters to make copies as needed.
This package of Maintenance Log Masters contains 6 logs:
Log 1 - Daily Maintenance
Log 2 - Daily System Check - ABS
Log 3 - Daily System Check - CHK
Log 4- QuikLYTE® Results
Log 5- Weekly/Monthly Maintenance
Log 6- Instrument Log
• Record maintenance information in the appropriate columns of these maintenance logs as you
perform these procedures.
• Use the Instrument Log (Log 6) to record any maintenance you perform that is not part of scheduled
maintenance, such as Replacing the Source Lamp.
• Procedures for the scheduled maintenance listed in these logs are detailed in your Operator’s Guide.
Refer to these procedures as necessary.
• Complete documentation of maintenance procedures is beneficial in instrument and chemistry
troubleshooting.
The Dimension® EXL ™ system is designed to process clinical laboratory specimens, some of which may
be a potential biohazard. It is important to follow standard laboratory practice for protection from
biohazards when you place specimens on the instrument and when you perform maintenance and
troubleshooting procedures.
10
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31
LOCI®
Are all
Reagent 1 Reagent 2 Sampler HM RMS* Highest
wavelengths
Value
10
11
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14
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19
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Na K
53 to 53 to Bottle Bottle
Date -55 to -40 > 0.8 < 0.6 <1.4 <0.04 ≤ 1.0 Initials
65 65 Value Value
140.00 4.00
Weekly
Monthly
(HM)
* If more than 100 IMT samples are run daily, clean IMT System every 15 days.
** Instruments with RMS Only
^ Perform System Check after replacing HM pump heads
2011/09 2-1
Safety and Specifications Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Safety
General Safety
To operate the instrument, you must be proficient in its operation,
maintenance, and alignment procedures. To ensure safety, follow basic
precautions.
• Always wear gloves when operating the Dimension® EXL ™ system.
• Observe all warnings and cautions in the manual.
• Remove safety guards only if specifically instructed in the procedures.
Replace all guards after completing the procedures.
• Stow cables and tubing properly to eliminate tripping hazards.
• Use only specified cleaners on the Dimension® EXL ™ system. Using other
than the specified cleaners will cause imprecision in some methods.
• Review the Flex® reagent cartridge Instructions for Use (IFU) for specific
chemicals and safety information about the reagents in each method
cartridge.
• If the equipment is used in a manner not specified by the
manufacturer, the protection provided by the equipment may be
impaired.
Instrument Removal
Please contact a Siemens Healthcare Diagnostics service representative for any
instrument removal for repair or disposal.
Safety Notes
Warnings and cautions are included throughout this guide to emphasize
important and critical instructions.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Safety and Specifications
Safety Labels
Safety labels are affixed to the instrument to alert you to safety considerations.
Label Description
Potential Biohazard Indicates an area of the instrument that could have been in
contact with biohazardous materials. Do not handle the
contents or touch the area unless properly protected. Refer to
applicable laboratory procedures and to the guidelines set
forth by the Department of Labor (OSHA) 29CFR Part
1910.1030, Occupational Exposure to Bloodborne Pathogens:
Final Rule.
Pinch Hazard Indicates an area of the instrument where the operator can be
exposed to moving parts. Be careful around these parts when
performing diagnostic and maintenance operations with
safety shield removal.
Puncture Hazard Indicates an area of the instrument where the operator can be
exposed to a sharp tip that could puncture the skin. In
particular do not extend fingers under the guard over the
sample area during operation.
Burn Hazard Indicates a heated area of the instrument that can burn an
operator. Be sure to power off the instrument and let these
areas cool before touching them or performing diagnostic and
maintenance operations around them.
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Safety and Specifications Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Label Description
Protective Earth Terminal Indicates the terminal that connects the power supply line
external earth (ground) to the instrument.
Open Lid Indicates an area of the instrument where the operator can be
exposed to a closing lid. Be careful around these parts when
performing diagnostic and maintenance operations.
Crush Hazard Indicates an area of the instrument where the operator can be
exposed to moving parts. Be careful around these parts when
performing diagnostic and maintenance operations.
Link Symbol Indicates that the instrument is being operated from a remote
location.
Laser Label Indicates an area of the instrument where you can be exposed
to direct laser emissions. Do not look directly into the aperture
of the emitted laser beam. The maximum radiant power at the
aperture of the laser barcode reader is 1.0 milliwatt.
Printer Shelf Indicates the weight limit for the printer shelf. The shelf is in
the proper position when two clicks are heard, indicating that
both support brackets are locked into place.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Safety and Specifications
Label Description
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Safety and Specifications Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Symbols Key
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Safety and Specifications
Types of Shutdowns
There are two procedures for removing power from the Dimension® EXL ™
system: Controlled Power Shutdown and Emergency Power Shutdown. Use the
Controlled Power Shutdown when required for performing certain
maintenance procedures. Use the Emergency Power Shutdown when safety is
the primary reason for removing power.
The procedures in this section are for removing power from the Dimension®
EXL ™ system only. To remove power from the RMS only or from both the
Dimension® EXL ™ system and the RMS, see the RMS Operator’s Guide.
Controlled Removes power from all areas of the instrument except the compressor.
Before shutting the instrument down, performs a data backup to ensure
that all data and alignment files are saved. The Controlled Shutdown may
be required to perform maintenance procedures.
Emergency Removes power from the entire instrument. No data backup is performed
before power loss. Although the instrument performs an automatic data
backup every 15 minutes, any changes to files after the backup and before
the shutdown are not saved.
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Safety and Specifications Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
7. When the message "Do you really want to shutdown the computer?"
appears, touch option 1 or Alt/1 key.
8. Push the instrument main power switch to the down position.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Safety and Specifications
2. Turn OFF the UPS power by turning off the main power switch located at
the rear of the UPS, then press the UPS Off button at the front of the UPS.
The UPS will shutdown in approximately 30 seconds.
WARNING: You must press the UPS OFF button on the front of the UPS. If
you do not, full power is provided to the instrument by a fully-
charged UPS for 21 minutes, even after the power cord is
disconnected.
Figure 2-4: UPS Front and Rear
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Safety and Specifications Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Safety and Specifications
Installation Specifications
The Dimension® EXL ™ integrated chemistry system is installed by a qualified
Siemens representative. Installation includes a full checkout to ensure that the
equipment is fully operational.
Space Requirements For Dimension® EXL™ with LM System
Weight
1095 lb. (496 kg)
Dimensions
Length: 82 in. (161 cm)
Height: 66 in. (208 cm) (Height includes raised lids).
Depth: 41 in. (104 cm)
These dimensions are without the printer shelf elevated.
Add 18 in. (46 cm) to the length if the printer shelf is used.
Minimum Clearances
Left Side: 24 in. (60 cm)
Right Side: 3 in. (8 cm)
Rear: 5 in. (13 cm) beyond LOCI® module
The instrument requires 360-degree access and at least 36 in. (91 cm) of
working space on each side. Access to the rear of the instrument requires
moving it forward.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Safety and Specifications
Installation Specifications
The Dimension® EXL ™ integrated chemistry system is installed by a qualified
Siemens representative. Installation includes a full checkout to ensure that the
equipment is fully operational.
Space Requirements For Dimension® EXL™ 200 System
Weight
770 lb. (349 kg)
Dimensions
Length: 57 in. (140 cm)
Height: 66 in. (208 cm) (Height includes raised lids).
Depth: 41 in. (104 cm)
These dimensions are without the printer shelf elevated.
Add 16 in. (41 cm) to the length if the printer shelf is used.
Minimum Clearances
Left Side: 24 in. (60 cm)
Right Side: 3 in. (8 cm)
Rear: 5 in. (13 cm) beyond LOCI® module
The instrument requires 360-degree access and at least 36 in. (91 cm) of
working space on each side. Access to the rear of the instrument requires
moving it forward.
No leveling is required. However, a reasonably level floor is required for proper
operation. The two front casters of the instrument should be in their locked
position during operation.
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Safety and Specifications Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Power Requirements
Instrument Power Specifications
Maximum
Power
Nominal Line Line Voltage Nominal Line Continuous
Consumption
Voltage vac Range vac Frequency Hz Current,
WATTS
AMPS
Leakage Current
Leakage current complies with the requirements of CSA C22.2 No.1010.1 safety standards for
laboratory equipment in non-patient vicinity areas.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Safety and Specifications
Water Requirements
The Dimension® EXL ™ system requires an external source of CLSI Clinical
Laboratory Reagent Water or the use of Purified Water Diluent. The external
system that provides this deionized water must be connected to the water inlet
connector in the rear of the instrument. Maximum rate of water consumption
and maximum rate of liquid waste output is 0.53 gal. (2.0 L)/hr. Purified Water
Diluent is not recommended for use with the heterogeneous immunoassay
(HM) module.
Drain line check valves are installed to prevent back siphoning. Maintenance of
the disposal point is the responsibility of the operator. The disposal point
should be selected in accordance with local hazardous waste guidelines.
The purified water supply systems for the Dimension® EXL ™ system must
produce water to the specifications shown below. These specifications meet
the definition of CLSI Clinical Laboratory Reagent Water (Clinical Laboratory
Standards Institute, C3-A4, Vol. 26, No. 22). Water supply maximum valve
pressure is <55 psi.
1Not applicable to CLSI Clinical Laboratory Reagent Water (CLRW), but required for proper
instrument performance.
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Safety and Specifications Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Printer Shelf
Note: The printer shelf can support a maximum of 50lb.
(23kg)
The Dimension® EXL ™ instrument includes a shelf folded into the left side
which can hold the printer.
• To raise the shelf, grasp the lower edge and pull out and up until you hear
the supports click into position. Press slightly on the shelf to ensure the
supports are fully engaged.
• To lower the shelf, pull up on the release levers on both supports. Push the
shelf down and toward the instrument until it clicks into its storage
position.
Additional Requirements
Phone Line
A dedicated, direct phone line should be connected to the Dimension® EXL ™
system. Only the Dimension® EXL ™ system must use this phone line. Also, this
phone line must not be connected through a switchboard.
Specifications for this phone line are:
• Full Duplex – capable of two-way transmission.
• Standard phone jack connection – RJ11C or RJ11W (not new digital)
Host Interfacing
For host interfacing, a 9-pin female connector is required for hookup to the
male connector on the Dimension® EXL ™ system host communications port.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide System Overview
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System Overview Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide System Overview
Features
• Performs tests in random order.
• Uses the Siemens Flex® reagent cartridge and onboard cuvette
manufacturing system.
• Uses the Siemens exclusive QuikLYTE® integrated multisensor for
electrolyte testing.
• Performs up to 440 photometric chemistry tests and 187 IMT tests per hour
on serum, plasma, urine, or cerebrospinal fluid samples.
• Performs up to 167 heterogeneous immunoassays per hour.
• Performs automatic reflex testing.
• Performs automatic panic reruns.
• Uses various sizes and styles of primary sample tubes.
• Uses 1.5-mL sample cups.
• Uses 1-mL SSC on top of barcoded tubes for short volume samples.
• Holds up to 44 Flex® reagent cartridges in a non-CFC refrigeration system.
• Holds an additional 44 Flex® reagent cartridges with RMS installed
• Performs automatic reagent preparation.
• Has an easy-to-use computer.
• Has ten user-programmable panel keys.
• Has the ability to link with other Siemens analyzers (with or without
barcode generation capability) or with a Laboratory Information System
(LIS).
• Has the ability to produce calculated results.
• Has automatic rerun capability.
• Has automatic dilution for overrange samples.
• Performs an automatic dilution on urine patient and urine QC samples.
• Has capability to process user-defined methods.
• Has the ability to automatically remove reagent cartridges when these
cartridges are empty or their onboard life has expired.
• Provides for barcoded QC panel processing.
• Includes automated calibration setup and acceptance.
• Uses touchscreen monitor with visual/audio alerts.
• Uses the HIL feature to help determine usability of sample.
• Uses the Siemens exclusive LOCI® technology for processing
high-sensitivity immunoassays.
• The ability to detect clots during sample aspiration.
• Automated CHK System Check
2011/09 3-3
System Overview Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Clot check functionality adds additional system Error Codes. The new codes are
as follows:
• (864) Sample Probe Clot- unable to clear
• (865) Clot Check Error - sample aborted
• (866) Clot Check hardware failure
• (867) Clot Check Error - hanging clot detected
• (868) Sample probe failed to enter the drain
Follow the ALT/M troubleshooting steps in Dimension® software if any of these
errors occur. The clot check feature adds a new IMT port that includes a clot
check drain. Once the system detects a clotted sample, the contents of the
aspirated sample is not returned to sample container. The remaining sample is
flushed down the IMT clot check drain during the clot check recovery
sequence.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide System Overview
Clot check also includes a bypass feature. This feature permits the operator to
bypass clot check hardware and run the system without clot check
functionality if needed. Clot check must be de-configured within the software,
and bypass tubing must be installed.
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System Overview Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide System Overview
# Description
1 IMT Lid
2 Sample Area
3 LOCI® Module
4 HM Area
5 Reagent Lid
6 Touchscreen
7 IMT Area
8 Keyboard
9 Printer Shelf
10 RMS
11 Control Boards
12 Computer
14 Pump Panel
18 Reagent Area
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System Overview Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
# Description
3 IMT Port
5 Flush Solution
6 Standard A
7 Standard B
9 Sample Diluent
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide System Overview
# Description
2 Vessel Holder
5 Wash Probe 2
6 Wash Probe 1
7 Wash Pump 2
8 Wash Pump 1
9 Wash Wheel
10 Incubate Wheel
12 Vessel Shuttle
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System Overview Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
# Description
1 R2 Reagent Am
2 Reagent Tray
3 R1 Reagent Arm
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide System Overview
# Description
1 Thermal Chamber
3 Flow Meter
5 Compressor
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System Overview Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
# Description
1 Printer
2 Safety Label
3 Shelf
4 Supports
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide System Overview
# Description
1 LOCI® Arm
4 Power Supply
8 Vacuum Assembly
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System Overview Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Software Overview
Using the Keyboard
Figure 3-10: Keyboard Layout
Test Keys
Use the test keys to select tests and panels of tests.
Figure 3-11: Keyboard Test Keys
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide System Overview
Use the test keys to select tests and panels of tests. The test keys labeled P1
through P10 are the panel keys. By programming groups of frequently used
tests to these ten panel keys, you can request a panel of up to 20 tests with
a single keystroke. (See “Creating Panel Keys” on page 70 of Chapter 10:
Customizing). You can also customize which tests are on a test key. (See “Test
Key Assignments” on page 98 of Chapter 10: Customizing).
Figure 3-12: Test Key Panel Setup
Keyboard Overlays
Additional tests may be shown on the overlay above or below the test keys.
To select these tests, press the Alt key and the key indicated by the overlay. For
example, the TSHL test is on an overlay above the test keys:
Figure 3-13: Keyboard Overlays
Action Keys
Figure 3-14: Keyboard Action Keys
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System Overview Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Key Use
Stop The Stop key can be used only with the Control key. This key combination stops
all instrument operations in progress in a manner that will not damage the
instrument. All tests in progress are aborted; however, all scheduled tests are
retained in instrument memory. To resume operations, press the Reset key.
Pause The Pause key turns the sampler system off, preventing the photometric sample
arm from moving. Press the Pause key again to restart the sampler system.
Reset The Reset key is used to clear error messages on the screen. It initializes any
modules that are not being used and causes the instrument to resume
processing. This key is also used to resume operations after you use the
Control/Stop key combination to halt processing.
Run The Run key causes the instrument to look for and process any new samples. It
is equivalent to the F4: Run key on the Load List screen.
Function Keys
Figure 3-15: Keyboard Function Keys
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide System Overview
Keypad Keys
Figure 3-16: Keypad Keys
Key Use
Delete When entering information in a field, hold down the Shift key and press Delete to
delete all characters to the right of the cursor in a field.
Exit Press the Exit key to leave the screen that is currently on the display; the system
displays the previous screen.This key operates the same way as the Exit key on the
touchscreen.
Help Press the Help key at any time to get information about the screen that is on the
display or the functions of various keys on the keyboard that are used with that
screen. Use the PgUp and PgDn keys to move through the help screen
information. Press the Exit key to return to the instrument screen. The operation
of the Help key in combination with other keys is explained in “Help Keys” in the
Appendix. This key operates the same way as the Help key on the touchscreen.
Alarm Off When there is a problem with the system, an alarm sounds. Press the Alarm Off
key to turn off this alarm. Once the alarm has been turned off, you must press
Alarm Off again to enable the alarm.
Enter Press the Enter key after entering data to store what you entered in the current
field or to activate a command. This key operates the same way as the Enter key
on the touchscreen.
Numbers Use to enter numerical data. Numerical data can also be entered using the
Keyboard keys.
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System Overview Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
These keys, commonly referred to as arrow keys, move the cursor on the
screen up, down, right, and left. They operate the same way as the arrow keys
on the touchscreen.
The left and right arrow keys move the cursor from data field to data field on
the screen. When these keys are pressed with the Shift key, the cursor moves
one space to the right or left within that data field.
Keyboard Keys
Figure 3-18: Keyboard Keys
The keyboard keys are basically the same as on a standard computer keyboard.
Keys that have special functions when used in a data field are described below.
Key Use
Backspace Deletes the character immediately to the left of the cursor when entering/
editing data in a field.
Enter Stores what you entered in the current field or to activate a command.
\ Place the backslash key at the far left of a data field to delete the entire entry in
a data field.
Highlight a character in a data field and press the backslash key to delete all
characters to the right of the cursor.
Alt Used in combination with other keys, displays other screens or performs
routine functions. See “Keystroke Combinations” in the Appendix for a
description of the key combinations.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide System Overview
The Dimension® EXL ™ system display has several distinct areas in which a
specific type of information always appears. These areas are:
• Instrument Status
• Segment Status
• Operating Conditions Status
• Error Message
• Applications
• Message
• Functions Keys
• Alert Keys
This section describes these areas and the information they provide.
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System Overview Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Status Meaning
Initializing The system is starting up. You cannot process samples or access the
sample wheel until the system has finished initializing. The sample
wheel moves during initializing.
Processing The system is processing samples, the IMT system is being calibrated,
or photometric calibrations or reagent hydrations are being
performed.
Diagnostics Diagnostic software is being used. You cannot process samples when
this box displays “Diagnostics.” The instrument must be in “Standby” to
access the Diagnostic software.
Status Meaning
Sampler Busy The system is using the sample handler or the sample wheel.
Waiting... You pressed the Pause key while samples were processing. The system
is waiting for an appropriate place and time to stop the photometric
sampler system.
Waiting...60 The instrument is 60 seconds from pausing. This will count down the
number of seconds until the instrument is paused (“Waiting...59,”
“Waiting...58,” etc.).
Samplers Off Appears when you press the Pause key. The photometric sampler
system has stopped and will not move until the Pause key is pressed
again.
Moving Wheel... The instrument is within five seconds of accessing samples in the
sample area.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide System Overview
Status Meaning
IMT Paused All activity in the IMT system has been paused. The IMT system will not
move, prime, or calibrate unless you exit the screen or press a function
key.
IMT Calibrating The IMT system is running a calibration. IMT tests can be scheduled
and will be run when status changes to “IMT OK.”
Na, K, Cl One or more of the individual sensors failed calibration or has been
overridden. The color indicates the status of each:
green = calibrated
yellow = you have overridden the IMT method
red = not calibrated
IMT Not Calib The IMT system is not calibrated. You cannot process any IMT tests
until the IMT system is calibrated.
IMT Not Config The IMT system has not been configured. You cannot process IMT
tests.
Status Meaning
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System Overview Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
A segment box with a dash indicates that the instrument has scanned the
sample wheel and did not identify a lettered segment in that segment
position.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide System Overview
Applications Area
Below the error message area is the applications area, the largest and most
frequently used area of the screen. You enter or edit sample data and make
test requests in the applications area.
The title of the screen always appears in capital letters on the first line. Below
the title are various text and data fields that make up the screen.
The color of the words in the Application Area of any screen indicate whether
you can change the information in that field:
• Black indicates a text field. You cannot change its information.
• White indicates a data field. You can change its information.
Message Area
The message area is below the applications area. This area can contain the
following kinds of messages:
Prompt When the system needs additional information about a certain task, it
displays a message and waits for your response.
Example: “Please enter your password, then press Enter.”
Question The system displays query messages when action is required or if you
have forgotten to press a required key or perform a certain task.
Example: “Press Enter to enter data?”
The function keys area is located at the bottom of the screen. It contains two
rows of four boxes each. The titles on these eight boxes correspond to the
eight function keys, F1 through F8, on the keyboard.
The use of these keys is explained where needed in applicable procedures. For
example, if you are at the Operating Menu screen and want to enter sample
data, you would press the F1 function key on the keyboard, which corresponds
to the F1: Enter Data box on the Operating Menu screen.
The titles of function key boxes change as each new screen appears.
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System Overview Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Alert Keys
Five alert keys are displayed vertically on the left side of the screen. These keys
are normally gray but change color to alert you of a situation needing your
attention. Press the key to find out the reason for the alert.
Key Purpose
STAT Status Displays the STAT Samples screen. Shows the STAT requests that are in
process and the time until the result will be available, as well as
completed STATs and STATs requested but not yet begun.
Sample Alert Displays the Sample Alert screen. Shows rerun status of sample
requests which encountered exceptions while processing (autodilute,
reflex, panic repeats, process errors)
Supplies Displays the Reagent Cartridge Alerts screen. Shows Flex® reagent
cartridge lots which are nearing an operator-defined depletion
threshold. Warns you that it is time to load cartridges for specific
methods.
QC Alert Displays the QC Tests Out of Range screen. Shows the method, QC level
and high or low status of QC tests.
Calib Alert Displays the Calibration Alert screen. Shows onboard methods/lots and
the amount of time left to calibration expiration. Shows onboard lots
which have triggered configurable calibration alert criteria.
Key Purpose
Run When you press this key, the instrument looks for and processes new
samples. It is equivalent to the Run key on the keyboard or the F4: Run
key on the Load List screen.
Home Closes the currently displayed screen and returns to the Operating
Menu (Home) screen. It is equivalent to pressing the Shift/Exit
keystroke combination on the keyboard.
Enter Press the Enter key after entering data to store what you entered in the
current field or to activate a command. Performs the same functions as
the Enter key on the keyboard.
Exit Closes the currently displayed screen and returns to the previously
displayed screen. It is equivalent to the Exit key on the keyboard.
Arrow Keys Move the cursor from field to field on the screen displayed in the
Applications Area. They are equivalent to the arrow keys on the
keyboard.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Setup and Supplies
This chapter contains procedures for daily setup and meeting system needs on
the Dimension® EXL ™ system.
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Setup and Supplies Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Daily Setup
Overview
The Daily Setup procedure includes four tasks:
• Cleaning the sample area and emptying cuvette waste
• Daily Maintenance
• Running a System Check
• Recording the daily maintenance results
Complete these procedures using the following tools and supplies:
• Damp cloth
• Scissors
Note: Systems with RMS configured should refer to the RMS
Operator’s guide for additional Daily Setup tasks.
4. Put the segments back into the instrument. Close the reagent and IMT
lids.
5. Press Pause to restart the sampler system.
6. Open the middle cabinet door and cut the cuvette string about 12 inches
down from the instrument. Be sure to cut between two cuvettes to
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Setup and Supplies
WARNING: The cuvettes and the contents of the cuvettes may present a
biohazard or chemical hazard. Follow standard laboratory
procedures for protection from biohazards and chemicals
when performing maintenance and troubleshooting
procedures.
Daily Maintenance
1. Display the Daily Maintenance Routines screen by pressing:
F4: System Prep > F8: Daily Maint.
Note: If all System Check Means are failing, and ABS/CHK lots were
recently changed, the operator must enter the carton value
from the ABS/CHK carton end flap every time a new ABS/CHK
lot is used.
2. If F2: Check Counts appears as a function key, press the key to see the
System Counters screen and the additional required maintenance.
(See “Understanding the System Counters Screens” on page 7 of this
chapter).
3. If F3: Chk HM Counts appears as a function key, press the key to see
what HM maintenance is required. (See “Understanding the System
Counters Screens” on page 7 of this chapter).
4. If F4: Chk RMS Cnts appears as a function key, press the key to see what
RMS maintenance is required. (See “Understanding the RMS System
Counters Screen” in the RMS Operator’s Guide.)
Note: Additional maintenance items appear in red. Follow the
appropriate replacement procedure in this Operator's Guide.
Check the RMS Operator’s Guide for RMS Daily Maintenance
requirements.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Setup and Supplies
• * The temperature range listed here is of the HM ring itself, not the air bath or liquid in a reaction
vessel. In order to maintain a constant temperature inside the reaction vessel, the system
compensates for ambient temperature, thus varying the HM ring temperature. It is common for the
HM ring temperature to vary throughout the day in order to compensate for ambient temperature.
In this manner, the system is able to maintain the temperature of the liquid in the reaction vessel
between 36.5º C and 37.5º C.
• Numbers in brackets such as [37.0] mean that the temperature is not current. Dashes inside
brackets [--] mean that one or more requirements for monitoring temperature are not met, for
example, the lid may be open.
Mean SD
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Mean SD
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Setup and Supplies
System Needs
System needs include:
Adding:
• Reagent Cartridges
• IMT Consumables
• Cuvette Film Cartridges
Performing:
• Calibration/Verification on photometric methods, LOCI® methods, and the
IMT system
• Quality Control
Before beginning sample processing, the system checks to see if any reagents
or supplies are needed or if any process control functions (calibration or quality
control) need to be performed. However, tests that are ordered through the
automatic test ordering features of autodilute, autoreflex, and panic values do
not generate a system need and are not processed if reagents, supplies or
control functions are required.
When you press F2:Process Single from the Enter Sample Data screen, F4:Run
from the Load List screen, or the Run key, the system checks its needs (the
yellow Needs Check icon appears) for processing the requested tests.
• If no system needs are required, the system begins processing.
• If system needs are required, the red Check Needs icon appears. You must
satisfy the system needs listed or choose to ignore them. If you choose to
ignore system needs, tests that require those needs are not processed.
Tests are processed and reported only if you ignore QC needs.
The System Needs screen:
• Shows which system needs must be satisfied to process all samples on the
Load List. Samples with no system needs are scheduled for processing.
• Shows function keys only for those categories of supplies and procedures
that are needed.
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Setup and Supplies Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
2. Decide if you want to fill all or just some needs. Use the table
"Understanding System Needs" on the next page to make your decisions.
3. To fill a specific system need, press its function key to see what is
needed. Function keys appear only for system needs that must be filled
to run the Load List. For example, in the screen above, to see which
reagent cartridge needs to be added, press F1: Reagents and fill the
need by following the appropriate procedure from the table below.
Table 4-4: Function Keys
Function Key Press the function key and follow this procedure
F3: Cal/Ver See “When to Calibrate or Verify Photometric and LOCI® Methods”
on page 3 of Chapter 6: Calibration and Quality Control.
F4: IMT Consums See “Replacing IMT Consumables” on page 21 of this chapter.
F5: Ignore Needs See “Understanding System Needs” on page 11 of this chapter.
F7: Sys Counters To replace the cuvette film cartridge, press F3: Film Load and see
“Replacing the Cuvette Film Cartridge” on page 42 of Chapter 7:
Maintenance.
4. If after filling a system need, other system needs are still required, the
System Needs screen reappears and allows you to press another function
key to fill another need. If no additional system needs are required, the
system begins processing your samples.
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Cartridges Not enough reagent available to run all As many tests as possible are run for
the tests. the method.
Cuvette Cartridge Not enough film in the cuvette film As many tests as possible are run.
cartridge to make all the necessary
cuvettes.
IMT Consumable The QuikLYTE® sensor or a required IMT As many Na, K, Cl tests as possible
fluid does not have enough assays are run.
remaining to run all tests.
OR
The time remaining for the QuikLYTE® All Na, K, Cl tests are run.
sensor or a required IMT fluid has
expired.
IMT System The IMT system is not calibrated. An IMT calibration is scheduled. If it
fails, no Na, K, Cl tests are run.
QC QC for these lots has not been run All tests are run.
within the specified time period.
Photo Method Calibration status is “Expired” for these All tests are run, but a test report
reagent cartridges. message will appear on the report
slip.
OR
Calibration status is “Never Calibrated” Tests are not run and a test report
for these reagent cartridges. message appears on the report slip.
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Setup and Supplies Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Supplies Alert
When the Supplies alert key changes to yellow, press the key to display the
Reagent Cartridge Alerts screen.
Figure 4-3: Reagent Cartridge Alert Screen
The screen sample above demonstrates three different scenarios for a reagent
cartridge alert:
• ACP: a single ACP Flex® cartridge is on board and has only five tests
remaining, five fewer than the designated alert threshold of 10.
• ALB: multiple ALB Flex® cartridges are on board, all with the same lot
number. The “Tests Left” field shows the cumulative number of tests from
all ALB reagent cartridges.
• CHOL: multiple CHOL Flex® cartridges from two different lots are on board.
The threshold of 161 is compared to the cumulative number of “Tests Left”
from all CHOL reagent cartridges.
When a method appears on the Reagent Cartridge Alerts screen, load enough
reagent cartridges to exceed the “Alert At” threshold for the method (see
“Adding Reagent Cartridges” later in this section).
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Field Information
Lot Number The six-character (two letters and four numbers) manufacturing lot
number for the cartridge.
Calib Exp Date The date that the calibration for that lot expires.
System Exp Date The date after which the cartridge will not be used by the system and must
be discarded.
In Use YES (red) The cartridge is currently being hydrated or is being used by
the system to process a Load List or a System Check.
NO (white) The cartridge is not being used.
Note: All of the procedures for use of the function keys are in this
chapter.
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Setup and Supplies Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
If the automatic loader will not insert the cartridge into the instrument, the
loader light begins blinking and a blinking reagent manager icon appears on
the screen. Remove the cartridge from the loader. Press the Alt/R key
combination to see why the reagent did not load.
• If the reagent tray is full, remove a reagent cartridge from the instrument
to make room for an additional cartridge. See “Removing Reagent
Cartridges” on page 16 of this chapter.
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• If the reagent cartridge barcode could not be read, see “Manually Entering
a Reagent Cartridge Barcode” on page 15 of this chapter.
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Setup and Supplies Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
WARNING: Wait until the red loader light is blinking before placing hands
or fingers into the loader to remove a reagent cartridge.
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5. When prompted, press F2: Remove Data. Use F1: Verify All to verify the
entire inventory.
Replacing HM Consumables
Replacing HM Fluids
The HM module requires three fluids:
•chemistry wash
•reagent probe cleaner
•sample probe cleaner
The volume of chemistry wash, reagent probe cleaner, and sample probe
cleaner is monitored by a low level sensor in each bottle.
Note: Dilution Check In Use Stability: 6 months when stored closed
at 2º-8º C. Chemistry Wash Stability: Opened: 30 days.
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Setup and Supplies Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
CAUTION: Do not overfill the holder. Overfilling may cause jams in the
feeder. Use the red line on the holder as a guide for the maximum
reaction vessel limit.
WARNING: The used reaction vessels and waste container liner are
biohazards; use your laboratory’s safe biohazard waste
disposal procedures when discarding.
2. Place a new biohazard bag in the HM waste container. Make sure the bag
is fully open and conforms to the inside walls and bottom of the
container. Slide the waste container into its holder.
3. From the Operating Menu press:
F4: System Prep > F6: System Counters > F6: HM Counters.
4. Move the cursor to the Vessels in Waste field, and press the Enter key to
change the field to YES. Press F1: Store Changes.
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Diluent 39
Standard A 300
Standard B 57
Flush 90
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Setup and Supplies Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Flush 3000
5. Press F8: Store Changes. An IMT calibration is scheduled for any fluids
that were replaced, or when the operator exits the screen.
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WARNING: Do not pull the holder all the way forward or it may lock.
Forcing it back into position may cause damage.
3. Slide the used QuikLYTE® sensor out of the holder. Insert the new
QuikLYTE® sensor. Apply equal pressure on both sides of the sensor
holder to close it properly.
Figure 4-9: Insert QuikLYTE® Sensor
4. Press F7: Change Sensor. The screen updates with the maximum assays
and time for the new QuikLYTE® sensor.
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Setup and Supplies Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
5. Press F8: Store Changes. The system automatically primes the Salt
Bridge Solution and the IMT Condition and Dilution Check screen
appears.
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Setup and Supplies Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
3. If the Bias field does not correct to 0%, follow the steps below:
a. Replace the bottle of QuikLYTE® Sample Diluent.
b. Use a new bottle of Dilution Check solution to rerun the dilution
check.
4. Press F4: Run Dilchk to display the IMT Condition and Dilution Check
screen.
5. Press F2: Dilchk and then pour fresh Dilution Check solution into a new
sample cup. Place it in the assigned position indicated on the screen.
6. Press F5: Start.
7. After running the dilution check:
a. If the dilution check passes, record the results from the printout on
the QuikLYTE® Results log sheet and then run QC for Na, K, and Cl.
b. If the dilution check does not pass, refer to the appropriate
discussion in this section to resolve why the dilution check did not
pass.
c. If the bias still fails, and pressing F1: Correct Bias does not correct
it, contact the Technical Solutions Center: Inside U.S.:
1-800-441-9250; Outside U.S. Refer to the local support team.
Note: Acceptable IMT dilution check SD values: Na: < 1.4, K: <0.04.
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Setup and Supplies Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
1. Press F4: Run Dilchk to display the IMT Condition and Dilution Check
screen.
2. Press F2: Dilchk. Pour fresh Dilution Check solution into a new sample
cup. Place it in the assigned position indicated on the screen.
3. Press F5: Start.
4. After running the dilution check:
a. If the dilution check passes, record the results from the printout on
the QuikLYTE® Results log sheet and then run QC for NA, K, and Cl.
b. If the dilution check does not pass but all the results are complete,
refer to “Resolving a Failed Dilution Check ” on page 25 of this
chapter.
c. If the dilution check still does not process completely, contact the
Technical Solutions Center: Inside U.S.: 1-800-441-9250; Outside
U.S. Refer to the local support team.
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This chapter contains procedures for processing samples and obtaining test
results on the Dimension® EXL ™ system.
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Preparing Samples
Sample Preparation
Whichever type of sample container you use, ensure that the sample quality is
acceptable for processing before you load it into a segment. The sample
should be free of clots, fibrin strands, and other impurities that may affect
metering fluids through the instrument. There should be no air bubbles in the
sample container.
While the Dimension® EXL™ HIL feature can alert you to undesirable hemolysis,
icterus and lipemia in a serum or plasma sample, proper preparation is very
important. Follow the sample container manufacturer’s instructions and
specifications on proper storage and handling techniques for mixing, timing,
and centrifugation.
Types of Containers
The following types of sample containers can be used on the Dimension® EXL™
integrated chemistry system:
• Sample cup with lid.
• Small sample container (SSC) supplied by Siemens Healthcare Diagnostics.
• Unstoppered 5-mL, 7-mL, and 10-mL primary sample tube.
• Pediatric tubes of various sizes and capacities.
All sample containers require an adapter to load them into the sample wheel
segments except for the 10-mL primary sample tube.
When loading a 5-mL or 7-mL primary sample tube, use only the adapters that
were shipped with the Dimension® EXL™ system. Dimension® adapters are easy
to recognize: the 5-mL adapter is teal (blue-green) and the 7-mL adapter is
beige.
There are three colors of segments (black, yellow, and orange) available from
Siemens for use in loading sample containers onto the sample wheel. All of
these segments are identical except for their color. You may find it useful to
use the yellow and orange colored segments to:
• Designate SSC segments.
• Differentiate sample cup and tube segments.
• Identify STAT segments.
• Identify segments with calibrators and verifiers.
• Identify instruments by segment colors (in multi-instrument laboratories).
• Separate work from satellite or other labs.
Additional orange and yellow segments can be ordered in packages of three.
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• Sample cups must be placed into one of the adapters supplied by Siemens
to load them into a segment. Push the sample cup completely down onto
the adapter.
Figure 5-2: Sample Cup Adapters
# Description
3 Beige 7 mL Adapter
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Adapter* Adapter
D L
Size Color
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WARNING: Do not place an SSC on a sample tube that presents the SSC at
a higher position than the tube that was used to perform the
maximum depth alignment for the SSC. Failure to follow
these instructions can result in operator injury, exposure to
biohazardous samples, or damage to the instrument.
Figure 5-3: SSC Tube
# Description
2 1 mL
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2. Display the Sample ID and Computer Menu screen from the Operating
menu by pressing: F6: System Config > F4: Computer, and then enter
the inner diameter of the pediatric tube, and if required designate PED
segments.
3. Perform the sample probe maximum depth alignment using the pediatric
tube and adapter combination that sits the highest in the segment.
Note: This alignment relates only to mechanical movement of the
probe and does not prevent the probe from aspirating
separator gel or blood cells when serum/plasma volume is
insufficient. It is the operator’s responsibility to ensure that
there is sufficient sample for the requested tests.
4. Always test the pediatric tube configuration before using actual patient
samples in the pediatric tubes.
When using pediatric sample tubes:
• Follow the manufacturer’s recommendations for factors such as tube
storage temperature and orientation, clotting time, spin time, and RPMs.
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Field Enter
Patient ID Appears only if External Printer mode = Test Results Only and
the LIS Communications mode = OFF.
Dilution (if used) Use the arrow keys to move the cursor down to the Location field and
then over to the Dilution field.
Location (if used) Use the arrow keys to move the cursor to this field.
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Sample Processing and Test Results Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
4. Press F1: New Sample to store the sample information. A new Enter
Sample Data screen appears with the Position field automatically
updated to the next available position (if one exists) in that segment.
5. Repeat Step 2 through and Step 4 to enter more samples.
Field Explanation
Mode To select a different mode, press F7: Next Mode. The type of sample
container used with the sample. Possible modes are:
• Primary Tube
• Barcode Tube
• Sample Cup
• SSC Tube - If Configured
• Limited Cup - No Level Sense
Fluid To select a different sample fluid, press F8: Next Fluid. There are nine
sample fluid types to choose from: 4 Sample Fluids, and 5 QC Fluids.
Sample Fluids
• Serum
• Urine
• Plasma
• CSF/Blood
QC Fluids
• SerumQC1
• SerumQC2
• SerumQC3
• UrineQC1
• UrineQC2
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Field Explanation
Priority The system automatically sets the priority to Routine. To select a different priority,
press F4: Next Priority.
There are five priorities to choose from:
• Routine
• ASAP
• STAT
• QC
• XQC (Crossover QC)
When QC or XQC priority is selected, the sample fluid must be set to SerumQC1,
SerumQC2, SerumQC3, UrineQC1 or UrineQC2. If there are two Flex® reagent lots
of the method on board and they have been calibrated, QC will be performed on
both lots.
Volume This should be used for reference only. It shows how many µL of sample are
needed to run the tests requested. It does not include the dead volume of the
sample container.
Do not use the volume field to determine the amount of sample needed for
processing.
Dilution Enter a dilution factor in this field if you manually made a dilution of the sample.
Enter your manually made dilution factor as a whole number. Remember to check
the Method IFU for the proper diluent to use for that method.
For example, to make a times-10 dilution, you would dilute one part of sample
with nine parts of diluent. The dilution factor would be:
(1 + 9) / 1 = 10
You would enter 10 in the Dilution field.
Dilution limit is 1:99. The highest factor you can enter is 100.
When a dilution factor is entered, that sample will not be autodiluted by the
instrument, except in certain circumstances see “Automatic Dilutions” on
page 48 of Chapter 10: Customizing. To move the cursor to the Dilution field,
move it to the Location field and press the right arrow key.
Location This is a six character optional field. It might be used to indicate the location of the
patient in the hospital (wing 2 or rm 214) or to indicate some other type of helpful
sample identification information for your laboratory.
Tests Select tests by pressing a test key or a predefined panel key. Up to twenty tests can
be ordered for a sample.
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Sample Processing and Test Results Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Note: Reminder, all batch samples are run with a Routine priority.
1. Using the Enter Batch Sample Data screen, enter information in the
following fields:
• Position—segment letter and position number where you
will place the first sample of the batch.
• Batch ID—the unique identification number for the batch.
• Number of Samples to process—the number of samples in
the batch.
• Tests—use the test keys or panel keys P1–P10.
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To change Use
Note: All remaining sample positions for the batch are assigned
automatically to onboard segments alphabetically and
numerically beginning with the segment position entered in
the Position field.
3. Press F1: Assign Pos.
4. Repeat steps 1 through 3 to enter more batch samples.
Note: If onboard segments in the segment status area of the screen
are A, X, L, M, then the remaining samples are automatically
assigned to next available positions in the segment.
5. Press F3: Load List and use the Load List to load the samples in their
assigned segment positions.
6. Make a separate handwritten list of patient samples and their positions
on the segment wheel.
7. Press F4: Run or the Run key.
Note: To add single (non-batch) samples from the Enter Batch
sample Data screen, press F4: Enter Data.
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Sample Processing and Test Results Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Loading Samples
1. For samples without barcode labels, use the Load List screen to see the
segment position you assigned to each sample. After you enter the data,
press F3 to view the assignment. The words “New Samples” will be
displayed in the upper right-hand corner of the Load List screen. If they
are not, press F2: Next Status.
Note: Load List segment positions: c = Sample Cup, l = Limited Cup -
No Level Sense, t = Sample Tube, x = SSC.
Figure 5-5: Load List Screen
2. Ensure that any lids on sample cups are pressed down completely and
that all stoppers have been removed from sample tubes.
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WARNING: Do not place your hands in the sample wheel area while the
instrument is initializing or processing. You could injure
yourself or damage the instrument.
WARNING: Test tubes must be fully seated to the bottom of the adapter.
Give them a slight push before inserting the segment in the
instrument. Erroneous results can occur if a primary sample
tube is not completely seated in its segment position.
Do not touch tube or segment while the instrument is
operating.
Note: Barcode sample tubes will not appear on the Load List screen
until they are located on the instrument during the scan of
segments after pressing Run. LIS-downloaded, non-barcoded
samples do not appear on the Load List screen until they are
assigned a segment position. See “Processing Samples
Downloaded from an LIS” on page 20 of this chapter to
assign positions.
4. Position labels so that the barcode is visible in the opening of the
segment. They can then be read by the barcode scanners.
Figure 5-6: Barcode Label Positioning
5. Completely seat the segment in its position on the sample wheel. Do not
remove segments when the Moving Wheel Light is on or photometric
sampler status box displays Moving Wheel.
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Processing Samples
When the sample information is available and segments have been loaded into
the sample wheel, begin processing by selecting the appropriate option. Three
ways to begin processing samples are:
• Processing samples from Standby status
• Adding samples while the system is in Processing status
• Processing samples downloaded from an LIS
Select the option that is appropriate for your current workload.
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WARNING: Do not place hands in the sample wheel area while the
instrument is initializing or processing. You could injure
yourself or damage the instrument.
Figure 5-8: Moving Wheel Light
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Communications F6: System Config > F4: Computer > Mode Send ID/Receive
Set Up F4: Communications (or Send/Receive)
Sample ID/ F6: System Config > F4: Computer Sample Sample cup (or to the
Computer Menu Edit type of sample container
used most frequently).
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6. Repeat Step 2 through Step 5 until all required asterisked (**) samples
have been assigned positions and loaded.
7. Press the Run key on the keyboard or touchscreen to begin processing.
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Sample Processing and Test Results Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
From the Sample Status screen, check that the sample status category you
want to view appears in the brackets in the upper right-hand corner of the
screen. If this is not the appropriate status category, press F2: Next Status
until the required status category appears.
Status Meaning
Entered This sample’s data has been entered into a Load List, but you have not requested the
system to run this sample yet. This sample‘s data can still be edited before processing.
Ready This samples data has been entered into a Load List, the sample has been loaded into
the sample area, and you have requested the system to run this sample. This sample’s
data can still be edited before processing.
Begun The system has begun to process tests for the sample; some test results may be
available. You can see any completed tests by moving the cursor to the sample and
pressing F8: Test Results. Additional tests can be added to this sample even though
processing has already begun.
Done All tests for the sample have been processed; all test results are available. You can see
these results by moving the cursor to the samples and pressing F8: Test Results. This
sample can be edited and rerun.
Printed All tests for the sample have been processed; all test results have been sent to the
printer. This sample can be edited and rerun.
Report All tests for the sample have been processed; all test results have been sent to an
external host computer. This sample can be edited and rerun.
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Entered but not yet processing Not Started (if alert is active)
Entered (if alert is not active)
There are four display modes for the STAT Samples screen, depending on your
configuration See “Configuring the STAT Status Alert Key” on page 75 of
Chapter 10: Customizing. To change the display, press F3: Next Display.
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Sample Processing and Test Results Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Mode Displays
Show Processing Displays all STAT samples currently processing. The When
Available field is updated every five seconds. When a sample is
completed, it is removed from this list.
STATS Not Started Displays STAT samples entered but not started within a specified
time period.
Additional function keys on the STAT Samples screen can save you time by
displaying screens to research and resolve errors. To use the following function
keys, first move the cursor to an individual sample.
F1: Test Results Displays the Test Results screen. For additional information, see
"Displaying Test Results" later in this section.
F2: Edit/Rerun Displays the Enter Sample Data screen. For more information, see
"Editing and Rerunning a Sample" later in this section.
F5: Clear Alert Removes the yellow or red alert status from the selected sample and
the stat key.
F8: Complete Alert Available only when the STAT complete alert is configured for
Selectable. Highlight a sample which is processing or not started.
Press F8: Complete Alert. When processing is complete for the
highlighted sample, the alert is activated.
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Field Information
Meth The test method that is being rerun or reflexed for the sample.
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Use the Segment Status - All Segments screen shown below, to view the
processing status of segment positions for all segments. From the Segment
Status - On Board Segments screen, press F1: See All to view this screen. Use
this screen when pre-entering samples into segments that are not currently on
the instrument, or when the availability of segment positions is unknown.
Table 5-3: Letters and Colors Used for Sample Status
N No Data Red
E Entered White
R Ready Green
B Begun Yellow
P Printed Blue
P Processed Assay complete, vessel has been used and will be discarded.
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Sample Processing and Test Results Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
The dot on the screen above status position 1 and the line above position 23
correspond to the white alignment dot and the white alignment mark on the
incubate wheel itself. If there is a vessel listed on this screen that you need to
locate, use these two known reference points and refer to the illustration
below. Position/slot 1 is always the first slot counterclockwise from the white
alignment dot. All other positions/slots are numbered clockwise starting from
position/slot 1.
Figure 5-11: Incubate Wheel Position
# Description
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WARNING: Do not report a test result that appears on the printed test
report with a test report message whose meaning indicates
that it is non-reportable, even though a result may appear on
the printed report slip.
A test result line on the test report can display only one test report message. If
more than one message has affected the result, the instrument prints the
highest priority message. See “Test Report Message Priorities” on page 26 of
Chapter 11: Appendix. See “Test Results with Reference Range Indicators” on
page 13 of Chapter 11: Appendix for an alphabetical listing of all the test
report messages along with the appropriate operator action.
WARNING: Do not report a test result that appears on the printed test
report with a reference range indicator if it also appears with
a test report message whose meaning indicates that it is
non-reportable.
These reference range indicators appear next to a result according to the
ranges the laboratory has programmed for that method in the Method
Parameters screen. See “Entering Method Parameters” on page 45 of Chapter
10: Customizing. Remember to follow laboratory procedures for lp and hp
indicators.
HIL Index
The HIL index can alert you to potential interference from hemolysis, icterus,
and lipemia in a sample, where:
• H = hemoglobin resulting from lysis of red blood cells
• I = icterus resulting from endogenous bilirubin
• L = lipemia or turbidity caused by insoluble lipids
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When the HIL feature has been programmed (See “HIL Feature” on page 71 of
Chapter 10: Customizing), the instrument automatically pipets 20 µL of sample
into an empty cuvette along with system water. Spectral absorbance
measurements are used to generate a sample-specific HIL index. The HIL index
appears on the report slip as a three-digit value where:
• 1st digit = H index
• 2nd digit = I index
• 3rd digit = L index
Each index value correlates to an approximate concentration for each of the
potential interferents, as specified in this table:
Table 5-5: Concentration of Potential Interferents
H I L
Hemoglobin Bilirubin Intralipid ™
Index (mg/dL) (mg/dL) (mg/dL)
1 H 25 I2 L 25
If the following conditions are met, the test report displays the “HIL Interf”
message next to the affected test result:
• The HIL Operating Mode has been set to an “AUTO-ON” mode.
• A method with entered Alert Index values between 2 and 6 has been
processed on the sample.
• Any of the measured HIL index values (H, I or L) is greater than or equal to
the corresponding Alert Index value entered for that method.
If the “HIL Interf” message is displayed, follow your laboratory’s procedure for
reporting results when the sample is hemolyzed, icteric and/or lipemic.
If the maximum number of tests (36) has been ordered for a sample, HIL is not
processed.
Clot Check
A test result with a "ClotCheckErr" rest report message will not include a
numerical result. Any successfully completed test results from the same
sample cup will be displayed. Any tests that have not yet aspirated sample
from the same sample cup will be aborted, and have an "Aborted Test"
message associated with them. The figure below is an example of a test report
with a successful test result, a test result with a "ClotCheck Err" and the
subsequent aborted tests. Printed test results are not automatically reordered
to display clot check errors before aborted tests.
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The order for listing test results is configureable. Tests results can be printed
and displayed on the screen in the order they were processed or a customized
order. See “Selecting a Test Result Order” on page 97 of Chapter 10:
Customizing.
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The top header of the instrument printer’s test report can be customized with a
laboratory name. See “Configuring the Printer” on page 79 of Chapter 10:
Customizing.
Table 5-6: Test Report
Test Description
HIL Indicates the three indices for HIL measurement in the sample.
CA This indicates that two CA tests were requested and run on this sample.
crea These lowercase letters indicate that this method’s standard sample volume
was changed on the Method Parameters screen or the method was correlated.
See “Entering Method Parameters” on page 45 of Chapter 10: Customizing.
MG The result exceeded the assay range of the method. Although a result appears
with an "HI" test report message, it cannot be reported because of the "assay
range" non-reportable test report message.
VANC The result was above the assay range of the method and could not be
calculated. No result is reported with the "above asy rng" non-reportable test
report message.
CA The last line was automatically calculated by the instrument because more
than one CA test was run on the sample.
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Try using the asterisk (*) as a wild card when using F6: Search. See “Searching
for a Sample” on page 36 of this chapter. To see which segment position was
assigned to a sample, press F3: Position. To set up a customized order for
viewing and printing test results, see “Selecting a Test Result Order” on
page 97 of Chapter 10: Customizing.
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Search Examples
Table 5-7: Search Examples
Search Result
*Smith Samples that end with Smith. It would find: John Smith, 123-
Smith.
It would not find: John Smith-123, Smith-Jones.
123**9 Numbers that begin with 123, end with 9, and have two characters
between the 3 and 9.
It would find: 123649, 123AZ9, 123GB9, 1235W9.
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Screen Action
Load List Press Alt/L to display the Load List and press F2: Next Status to
access all. If the sample is still on the Load List, move the cursor to
the sample and press F8: Edit Sample.
Sample Status 1. Press F2: Next Status until the status category in the upper right
corner of the display changes to the status category of the
sample, if known or All.
2. Find the sample in this list by either moving the cursor to the
sample using the arrow keys or by pressing F3: Search and
entering the required search pattern.
2. The Enter Sample Data screen or the Add Tests screen will appear.
Change or add information. (If the Add Tests screen appears, you can
only add tests to the sample).
3. After you have edited the information:
a. Press F2: Process Single or the Run key to begin processing the
sample.
b. Press F3: Load List to enter the sample into the Load List. Then
press F4: Run or the Run key to begin processing all samples shown
on the Load List.
From the Enter Sample Data screen, you can also press F1: New Sample to
enter a new sample.
Note: If the status of the sample to be edited is Begun, the Add
Tests screen appears. You only can add tests to the sample or
change its priority. You cannot change the sample’s container
until it finishes processing.
Note: When the Enter Sample Data screen appears, a message
provides information about the sample to help you with
rerunning.
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Segment Selection
* Any segment currently appearing in the segment status box that has
samples with errors on it.
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3. Place the cursor on the sample to be edited on the Load List screen.
4. From the Load List screen press F8: Edit Sample.
5. F8: Edit Sample will display the Enter Sample Data screen with all
original tests displayed.
6. After editing the sample, press F2: Process Single or F3: Load List to
return to the Load List screen.
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Sample Troubleshooting
Resolving a Short Sample Detected
Figure 5-16: Short Sample Icon
When the short sample icon appears, the instrument also sounds the alarm
and displays the error message "No Sample Found During Level Sense". This
indicates that there is not enough sample in the sample container to perform
all the tests requested. You have three options:
• Add more of the same sample to the sample container.
• Reduce the number of tests on the sample using F8: Edit Sample.
• Transfer the sample into a different sample container using the procedures
below.
1. Press the Alt/L key combination to display the Load List screen. View the
list of samples that do not have enough fluid to perform the requested
tests.
Figure 5-17: Load List Short Samples
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Sample Processing and Test Results Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
2. In the screen above, position A6 has a “t” after it, indicating that sample is
currently in a tube. Sample container letter designations on the Load List
screen are:
a. t = sample tube
b. c = sample cup
c. x = SSC
d. p = pediatric tube
e. l = limited cup - no level sense
Table 5-2 indicates which procedure to use.
Table 5-2: Sample Container Procedures
Tube (with bar code) Short Sample – Primary Tube with a Bar Code
Tube (no bar code) Short Sample – Primary Tube without a Bar Code
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WARNING: Failure to place the sample cup into the same segment
position that the sample tube was in will cause erroneous
patient identification and erroneous results.
4. Press the Pause key.
5. From the Load List short sample screen, move the cursor to the short
sample. Press F8: Edit Sample to display the sample’s Enter Sample Data
screen. Press F7: Next Mode until the Mode field changes to "sample
cup".
6. Press F2: Process Single.
WARNING: Failure to place the sample cup into the same segment
position that the sample tube was in will cause erroneous
patient identification and erroneous results.
4. Press the Pause key.
5. From the Load List short sample screen, move the cursor to the short
sample. Press F8: Edit Sample to go to the sample’s Enter Sample Data
screen. Press F7: Next Mode until the Mode field changes to "sample
cup".
6. Press F2: Process Single.
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WARNING: Wait until all processing tests are completed and the
instrument is in Standby before opening the instrument lids
to troubleshoot this error code.
1. Press Reset.
2. Open the front instrument door and unlatch the pump panel door. The
clot check assembly is mounted to the underside of the sample wheel
hub.
3. Check the connector located on the left side of the clot check assembly
which is attached to the clot check transducer board for proper seating of
connector P1/J1.
4. Check the tubing for proper connections and water leaks. If there is a leak
and the tubing connections are secure, the clot check transducer board
needs to be replaced. Contact the Technical Solutions Center: Inside U.S.:
1-800-441-9250; Outside U.S. Refer to the local support team.
5. If the clot check transducer connections appear secure, inspect the clot
check transducer connections at the CAN board.
Note: These connections are located on the CAN board in the LOCI®
module at the back of the instrument.
6. Open the door of the LOCI® module (the CAN board is the silver box
immediately seen in the opening) and check all the connections on the
CAN board.
7. Check the baseline reading for the clot check transducer in the clot check
diagnostics screen.
8. From the main menu, press F7: Diagnostics > F1: Electromechanical >
F2: Sample System > F4: Clot Check.
9. In the clot check diagnostics screen, press F2: Run Test. Once the test is
complete, view the active baseline field. A standard reading is between
8,200-8,600 counts. A faulty transducer board will read less than 1,000
counts. A transducer board with no power will read approximately
32,000 counts.
10. If a defective clot check transducer board is suspected, the clot check
transducer may be bypassed until a Field Service Representative arrives.
See “Clot Check Bypass” on page 22 of Chapter 7: Maintenance.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Calibration and Quality Control
This chapter contains procedures for reagent calibration and quality control on
the Dimension® EXL ™ system.
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Calibration/Verification Overview
Calibration/verification is performed to maintain the accuracy of the
measurement processes for methods used on the instrument.
You calibrate nonenzyme methods and verify enzyme methods (except for
Lipase). Methods on the instrument are referred to as either photometric or
chemiluminescent methods except for Na, K, and Cl, which are processed on
the IMT system and therefore require the IMT system to be calibrated before
they can be processed. Calibrating the IMT system involves calibrating the
QuikLYTE® integrated multisensor for Na, K, and Cl.
For photometric methods, the Dimension® EXL ™ system uses the following
equations to convert an absorbance reading into concentration of analyte:
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Calibrating HA1C
To calibrate the HA1C method, refer to the “Calibrating the Hemoglobin A1c
(HA1C) Assay” procedure in the Hemoglobin A1c (HA1C) Kit Supplement.
Calibrating HB1C
To calibrate the HB1C method, refer to the Hemoglobin A1c (HB1C) Kit
Supplement.
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Calibration and Quality Control Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Calibration Alert
The Calib Alert key can be configured to change color when a calibrated lot
approaches or reaches its expiration date and when a Flex® cartridge is in
inventory but not calibrated. The threshold used (1 to 240 hours before
expiration) is operator-assigned and is the same for each method. See
“Configuring Calibration Alerts” in Chapter 10.
When the Calib Alert key is yellow, press it to display the Calibration Alert
screen:
Figure 6-1: Calibration Alert Screen
Field Information
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From the Calibration Alert screen, the operator can perform several tasks by
pressing the appropriate function key:
Table 6-2: Function Keys
Key Task
F1: Set Up and Run Highlight a method and press this key to display the
(see “Setting up and Running a Calibration” later in this chapter).
F2: Calib Review Press this key to display the Calibration Review screen when the alert
indicates auto-accept.
F3: Group Cals Press this key to display methods with calibrator alerts grouped by
Calibration Product.
F4: Config Alerts Press this key to toggle between displaying alerts or not displaying
alerts on the screen.
F5: Def Cal Product Press this key to enter a calibration product.
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Field Information
Lot If this is not the correct reagent lot number, press F1: Other Lot.
Status The calibration status of this lot for the method. A calibration for this lot cannot
be set up if its status is “Not Accepted”.
Calibrator Lot QCC PowerPak®: Lot number is automatically entered from previously defined
calibrator products.
Manual: Enter the calibrator lot number. The system uses the same calibrator
cup for methods which you type the exact same entry in the Calibrator
Product/Lot field. In this case, you will need to plays calibrator in only one set of
cups for each calibration setup.
Start at Position Enter the segment position where you will place the first cup. Do not use SSC
segments for calibrations.
Bottle Values QCC PowerPak®: Bottle values are automatically entered from previously
defined calibrator products.
Manual: Enter the bottle values from the calibrator product IFU in ascending
order (lowest to highest).
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Calibration and Quality Control Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Note: The status field for a method lot can be any of the following
options: Never Calibrated, In Progress, Not Accepted,
Calibrated, or Expired. A calibration cannot be set up for a
method if its status is “Not Accepted”. Accept or Reject the
calibration before proceeding.
4. Press F8: QC Yes/No to change the QC Levels fields to Yes.
5. Press F4: Assign Cups.
6. Repeat Step 2 through Step 5 to set up more methods for calibration.
7. Press F7: Load/Run to display the Load List screen and view a summary
of all the calibrations you have set up.
8. Load the samples as indicated on the Load List.
9. Press F4: Run or the Run key.
Note: After pressing Run, the Status field changes to “In Progress”.
When the calibration is finished, the Status field changes to
“Not Accepted”.
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Linear Logit
Intercept (b) 0.0 or clinically insignificant Intercept (b): 0.0 or clinically insignificant
Correlation Coefficient (r) 0.990 - 1.000 Correlation Coefficient (r): 0.990 - 1.000
Cancelling a Calibration
You can cancel a calibration only if it has been scheduled (F7: Assign Cups has
been pressed but you have not pressed F7: Load/Run,
F4: Run or the Run key). After a calibration is cancelled and rejected, the
Calibration Set Up screen Status field changes to “Rejected” for that lot. Since
the system will not use a reagent lot that has been rejected by the operator,
you need to recalibrate the lot.
1. From the Calibration Set Up screen, press F4: Cancel Calib.
2. Press the Exit key.
3. Press F3: Review Data.
4. Press the test key for the method you cancelled (be sure to check the lot
number).
5. Press F8: Reject Data and answer the prompt by pressing “y.”
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Calibration and Quality Control Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Key Function
F4: Plot Print Presents the information in a plot format and lets you print a hard
copy.
F6: See QC/Show HB Toggle key. SHOW HB is available only for HA1C/HB1C calibrations.
F7: Search Calib Displays calibration history for a Calibration ID that you specifiy.
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Calibration Troubleshooting
This topic describes troubleshooting for a calibration that has unacceptable
precision, calibration statistics or quality control.
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3. Check the information on the screen and make any changes to the fields
listed in the table below.
Table 6-5: Calibration Set-Up Screen
Field Information
Lot If this is not the correct reagent lot number, press F1: Other Lot.
Status The status of this lot for the method. A verification for this lot cannot be set up
if its status is “Not Accepted”.
Calibrator Lot QCC PowerPak®: Lot number is automatically entered from previously defined
verifier products.
Bottle Values QCC PowerPak®: Bottle values are automatically entered from previously
defined verifier products.
Manual: Enter the bottle values from the verifier product IFU in ascending
order (lowest to highest).
Note: To display tests setup for Auto Acceptance that do not auto
accept press Calib Alert. Highlight the method with
Auto-Accept alert. Select F2: Calib Review.
4. Press F8: QC Yes/No to change the QC Levels fields to Yes.
5. Press F4: Assign Cups.
6. Repeat Step 2 through Step 5 to set up more methods for verification.
7. Press F7: Load/Run to display the Load List screen and view a summary
of the verifications you have set up.
8. Load the samples as indicated on the Load List.
9. Press F4: Run or the Run key. After you press Run, the Status field
changes to “In Progress”.
Note: After the verification is run, the Status field changes to “Not
Accepted”.
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• If the verification statistics are acceptable, press F2: Accept Data (the
Status field on the screen changes to “Calibrated”).
• If the verification statistics are not acceptable, you must reject this
verification by pressing F8: Reject Data. See “Troubleshooting Verification
Statistics” on page 17 of this chapter to resolve the problem and rerun the
verification.
Cancelling a Verification
You can cancel a verification only if it has been scheduled (F7: Assign Cups
has been pressed but you have not pressed F7: Load/Run, F4: Run or the Run
Key). After cancelling and rejecting a verification, the Calibration Set Up screen
Status field changes to “Rejected” for that lot. Since the system will not use a
reagent lot that has been rejected, you will need to reverify this lot.
1. From the Calibration Set Up screen, press F4: Cancel Calib.
2. Press the Exit key.
3. Press F3: Review Data.
4. Press the method test key for the method you just cancelled (be sure to
check the Lot number).
5. Press F8: Reject Data. Answer the prompt by pressing “y.”
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Verification Troubleshooting
This topic describes troubleshooting for a verification that has unacceptable
precision, calibration statistics or quality control.
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4. You can elect to override a specific IMT method or troubleshoot the IMT
to resolve a failed IMT calibration. See “IMT Troubleshooting” on
page 17 of Chapter 9: Troubleshooting.
Note: To override a specific IMT method, use the arrow keys to
move the cursor box in the Override column to the required
method. Press the Enter key to change the field to “Yes”. If
you override the K method, the Na method will also be
overridden because the K method is required for accurate Na
results.
Electrolyte Coefficients
The following are the default coefficients used by the software when urine is
selected as the fluid type:
Table 6-7: Urine Default Coefficients
C0 C1
Na+ 0 1.0
K+ 0 1.0
Cl- 0 1.06
Indirect (diluted) C0 C1
K+ –0.2 1.05
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List Contents
Recommended Shows a list of reagent lots that are within X hours of their expiration date.
Lots You can set X using F4: Exp Period.
Same Product Shows all reagent lots that use the same calibrator/verifier product.
All Lots Shows all reagent lots that are in system memory.
Selected Lots Shows all reagent lots you have selected to be calibrated/verified from the
three status list screens listed above.
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Quality Control
Quality control (QC) is a system of checks to ensure that the instrument and its
associated materials meet with your laboratory’s acceptable standards of
performance. At Siemens Healthcare Diagnostics, quality control is carried out
through all phases of reagent and instrument production and assembly. This
ensures product quality and performance.
The laboratory is responsible for the proper functioning of the
Dimension® EXL ™ system after installation. Siemens assists in setting up the
instrument and ensures that the methods to be used initially are calibrated and
verified.
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Daily QC
Check the Dimension® EXL ™ system daily for proper performance by using one
of the System Check procedures found in Chapter 4: Setup and Supplies, and
by performing routine maintenance as described in
Chapter 7: Maintenance.
Each day you should also run two levels of quality control material of known
activity or concentration for each method you will run during that day. Record
the results of all control samples. If the results are outside laboratory
acceptable limits, investigate the cause immediately.
QC Materials
The quality control material used should not be the same material that was
used to calibrate or verify a method. This could cause an undetected error and
lead to inaccurate results.
Carefully follow the procedures provided by the manufacturer of the quality
control material for handling and reconstitution.
It is best to use a quality control material with a concentration (or activity) at a
clinical decision-making level (as used by your laboratory).
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Calibration and Quality Control Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Processing QC Samples
When you process a QC sample for a method, the system runs a test using each
Flex® reagent cartridge lot that is on the system for that method. All QC
samples, are processed like patient samples.
When your test results are complete, the QC status for that method becomes
valid, and the QC expiration time period begins. If you don’t process another
QC sample before the QC expiration time period is up, the QC status for that
method expires.
Using the Quality Control Status List screen, you can define the QC expiration
time period. For example, if you set the QC expiration time period for GLUC to
24 hours, the QC status of each lot of GLUC on the system will expire every
24 hours unless another GLUC QC sample is processed.
Crossover QC
Before using a new lot of QC material, you will want to perform crossover QC
tests on it. If you give a sample of the new lot of QC material a crossover QC
priority (XQC) on the Enter Sample Data screen, the system provides results for
the sample to use in calculating your new QC ranges for the new lot. However,
since the system does not compare these crossover QC results to the QC
ranges of the current lot number of QC material, these results do not affect the
QC status of the method. Crossover QC results are stored in the Method Review
files.
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Result Explanation
Error If an error occurs during QC processing which suppresses the result, the
method is flagged on this screen.
High The QC result is above the upper limit of the stored QC range.
Low The QC result is below the lower limit of the stored QC range.
Table 6-11 explains the tasks you can perform with the QC Alert function keys:
Table 6-11: QC Alert Function Keys
Key Task
F1: Test Results To view QC results, highlight the method and press this key. See
“Displaying Test Results” on page 35 of Chapter 5: Sample Processing and
Test Results.
F2: Edit/Rerun To rerun the QC, highlight the method and press this key. See “Editing and
Rerunning a Sample” on page 38 of Chapter 5: Sample Processing and Test
Results.
F3: Clear Alert To clear an alert (change key color from yellow to gray) without rerunning
the QC, highlight the method and press this key.
F4: Config Alert To set parameters for QC alerts, press this key. See “Configuring QC Alerts”
on page 78 of Chapter 10: Customizing.
F5: Define QC Product To display the Define QC Product screen, press this key. See “Defining QC
Products” on page 29 of this chapter.
F6: Group Alerts To group alerts with the same product definition, press this key. See
“Grouping QC Alerts” on page 33 of this chapter.
F7: Method Review To review the QC levels and applicable Westgard rule, highlight the method
and press this key. See “Reviewing QC Results” on page 68 of Chapter 10:
Customizing.
F8: Print To print the information on the screen, press this key.
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Calibration and Quality Control Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Entering QC Ranges
1. Press F5: Process Ctrl > F4: QC Ranges.
2. From the Quality Control Ranges screen, press the test key for the
method you want to edit.
3. Press the Lytes test key, then press F1: Next Method to see the K and Cl
methods.
4. For each QC level, enter the QC range (low and high), expected mean, or
expected SD as appropriate. The number of QC levels used determines
how many days of QC data can be stored in the software for a method.
Note: For the autoacceptance option you must enter a minimum of
two QC ranges.
Table 6-12: QC Levels
QC Levels Set for Each Method Days of QC Results Stored for Each Method
2 270 Days
3 180 Days
4 135 Days
5 108 Days
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Checking QC Status
An asterisk (*) to the left of the QC Expires column indicates that the QC for
that reagent lot has expired.
If the QC Alert option "Create a QC need when there is a QC Alert" is activated,
and a QC alert occurs, the QC Expires column does not display a date and time.
Defining QC Products
The Dimension® EXL ™ system will display up to 100 QC products. To display
this screen, press the QC Alert key, then press F5: Define QC Product.
1. Type the QC product name. Press Enter.
2. Type the product level. Press Enter.
3. Type the QC Lot number. Press Enter.
4. Use F3: Next QC Fld Lev to select a QC Level.
5. Use F4: Next Fluid to select the fluid appropriate for the product.
6. Change the Active QC and Cal fields with F5 and F6 if this product will be
active for daily QC and included with current calibrations. Press Enter.
7. Use the test keys to enter methods associated with the product.
8. Press F7: Store.
a. To enter additional levels of the product, change the product level,
QC fluid level and press F7: Store.
b. To define another QC product, press F1: New Product.
c. To view a list of defined products, display the Edit QC Products
screen.
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Calibration and Quality Control Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Editing QC Products
1. Display the Edit QC Products screen by pressing:
1. F5: Process Ctrl > F3: QC Status > F2: Edit QC Product.
Figure 6-5: Edit QC Products Screen
2. Highlight the product to edit and use the appropriate function keys to
make changes.
Table 6-13: Edit QC Product Function Keys
Key Function
F2: Delete Product Removes the highlighted product from the list.
F3: Sort by Prod/QC Fld/Fluid Toggles among choices for sorting the QC products list by product
name, QC fluid level, and fluid.
F6: Set QC Active/Set QC Inactv Toggles between activating and deactivating QC.
F7: Set Cal Active/Set Cal Inactv Toggles between activating and deactivating calibration.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Calibration and Quality Control
Defining QC Panels
Use this screen to create up to 50 different QC panel definitions with up to
36 methods in each. Each definition is associated with a specific sample
number, levels, fluids and methods. Panels are designed to run in small sample
(SSC) placed on barcoded tubes. Only SSCs can be placed in tubes. Sample
cups are not supported.
When an SSC with a panel ID is processed, the system completes the following
actions:
• Queries the LIS, if configured for the ID.
• Searches the QC panel database for a match.
Display the Define QC Panels screen by pressing:
F5: Process Ctrl > F3: QC Status > F6: Define QC Panels.
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Calibration and Quality Control Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Editing QC Panels
Use the Edit QC Panel screen to view a list of defined QC panels and to edit the
panel.
1. Display the Edit QC Panel screen by pressing the
F5: Process Ctrl > F3: QC Status > F7: Edit QC Panel
Table 6-14: Edit QC Panels Function Keys
Key Function
F2: Delete Panel Removes the highlighted panel from the list.
2. Highlight the panel you want to edit and press F1: Edit Panel to make
changes.
3. Move the cursor to field to be changed.
4. Type in the new QC product name or QC lot.
5. Use test keys to add tests and F2: Delete Test to remove tests.
Note: If adding tests to a panel always add to the product first.
6. Use the function keys to change Sample ID, QC Fluid Level and Priority.
7. Press F7: Store.
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Grouping QC Alerts
Use the QC Groups screen to combine methods with the same assigned QC
product and active QC alert into one sample ID and SSC. Using this feature lets
you run QC on a maximum number of methods in a minimum number of
sample cups or SSCs in barcoded tubes.
1. Press the QC Alert key.
2. Press F6: Group Alerts.
Figure 6-6: QC Groups Screen
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Maintenance
Chapter 7: Maintenance
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Maintenance Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Undiluted Bleach
All references to “undiluted bleach” in this guide refer to a product that meets
the following criteria:
• 5.25% sodium hypochlorite
• No additives
• No detergents
• No surfactants
• No fragrances
• Minimal impurities
Bleach Solutions
All references to a bleach solution, refer to a solution that is made by diluting
an undiluted bleach product that meets the criteria listed above with water.
For example, to create a 10% bleach solution, add 10 mL of undiluted bleach
to 90 mls of water to create 100 mL of 10% bleach solution.
All bleach solutions should be prepared fresh prior to use.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Maintenance
Weekly Maintenance
Only trained operators should perform this procedure.
Perform these tasks weekly, using the following supplies:
• Cotton swabs
• 0.1N sodium hydroxide
• Water
Cleaning HM Wash Probes and the R2 Reagent Probe
The HM wash station probes and the R2 reagent arm probe must be cleaned
weekly to remove any residue.
1. With the system in Standby, display the HM Pump Prime screen by
pressing: F4: System Prep > F7: Pump Prime > F6: HM...
Note: Navigating to the HM Pump Prime screen prevents any
automatic priming of the HM wash probes that may occur.
This is also the correct screen to prime the probes later in this
procedure.
2. Raise the IMT lid. Insert a long slender tool into the reagent lid latch.
Press firmly and raise the lid.
3. Dip a clean cotton swab in water and, beginning at the top of the probe,
wipe down the outside of both HM wash station probes.
Figure 7-4: Cotton Swab
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Maintenance Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
4. Turn the splined shaft on the R2 reagent arm until the R2 probe rises out
of the R2 reagent drain. Move the arm until you can access the R2 probe.
Figure 7-5: Splined Shaft
5. Dip a clean cotton swab in 0.1N sodium hydroxide and scrub the nut at
the top of the probe tube. Beginning at the top, wipe down the outside
of the R2 reagent probe.
Figure 7-6: R2 Reagent Probe
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Maintenance Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Monthly Maintenance
Only trained operators should perform these procedures.
The seven monthly maintenance procedures are:
• Cleaning the Clot Check Drain on the IMT Port
• Replacing IMT Pump Tubing
• Cleaning the IMT System
• Replacing Instrument Air Filters
• Styletting HM Wash Probes
• Replacing HM Pump Heads on wash station
• Cleaning the R2 and R3 Drains
The replacement procedures use tools and commonly replaced parts that are
provided in your Accessory Spare Parts kit. After using a spare part from this
kit, be sure to order a new one from Siemens Healthcare Diagnostics.
Cleaning the Clot Check Drain on the IMT Port
1. With the instrument in Standby press the Pause key and raise the IMT lid.
2. Fill a disposable pipette with undiluted bleach and dispense
approximately 1mL into the clot check drain 10 times. Allow the clot
check drain to empty itself before each subsequent addition of bleach.
Figure 7-7: Clot Check Drain
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# Description
2 Tubing X2
3 Tubing X
4 Pressure Plates
Note: Do not use the bottom tube position on the pump. The X
tubing goes around the top position of the pump and
connects to the straight (top) portion of the IMT pump.
7. Close the pressure plates.
8. Reinsert the pressure plates foot bar and turn it to lock in the pressure
plates.
9. Press Pause to restart the sampling system. Press F1: Prime Salt Bridge
solution.
10. Prime with Salt Bridge solution until the solution exits the IMT sensor and
is visible in the X2 tubing.
11. To return to the Operating Menu, press Home on the touchscreen or hold
down the Shift key and press Exit. The system automatically performs an
IMT pump alignment and IMT calibration.
12. Record completion of this procedure in the Monthly Maintenance Log.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Maintenance
CAUTION: You must replace the QuikLYTE® sensor after bleaching the IMT
system.
12. Replace the QuikLYTE® Integrated Multisensor. See “Replacing the
QuikLYTE® Integrated Multisensor” on page 22 of Chapter 4: Setup and
Supplies.
13. Record completion of this procedure in the Monthly Maintenance Log.
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Maintenance Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
CAUTION: When installing these filters, make sure that the air flow arrows
on the frame of each filter are pointing as indicated in Table 7-1.
Table 7-1: Replacing Air Filters
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Thermal Chamber This filter is located in the rear right corner of the instrument.
1. Pull the filter cover and filter off of the plastic frame. This filter does
not have any air flow arrows and cannot be installed backwards.
2. Remove all dust from the used filter (except the thermal chamber filter
Figure 7-11, which must be replaced) by washing with water and air
drying or by using a vacuum cleaner. You can reuse these filters next
month.
3. Record completion of these procedures in the Monthly Maintenance Log.
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# Description
4. Using a screwdriver, remove the plastic guard from the wash station by
loosening the two screws on the facing side until the guard can slide out
from under the screws.
5. Pass an IMT stylet completely through the aspirate probe of each wash
station probe to dislodge any obstructions/accumulations. Pass the stylet
down through the probe and pull the stylet out through the bottom of
the probe.
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# Description
1 Insert Stylet
2 Lip
3 Sleeve
4 Positioning Groove
5 Aspirate Probe
6 Dispense Probe
7. Reconnect the tubing to the probes. Table 7-1 on page 14 of this chapter
for more information.
8. Reinstall the bottom plastic guard onto the wash station.
9. Press F1: HM Wash Pump to prime the HM wash pump.
10. Perform a System Check.
11. Record completion of this procedure in the Monthly Maintenance Log.
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Maintenance Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Wash Station Raise the IMT and reagent lids. The aspirate and dispense pump heads are
located on the wash station frame. See Figure 7-15 of this chapter.
Probe Cleaner Open the front cabinet doors and the pump panel. The probe cleaner pump
heads are located on the top left side on the back of the pump panel assembly.
See Figure 7-16 on page 19 of this chapter.
# Description
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# Description
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b. Slide the pump head onto the shaft of the motor, allowing the
shipping plug to fall as the new pump head is installed. Snap the
pump head into place.
c. Reattach the tubing to the pump head.
CAUTION: The shipping plug (or “T”) must be inserted into the pump head
before installing onto the motor to prevent damage to the pump
rollers as the pump head is pushed onto the motor shaft.
6. Prime the fluid for the pump of the pump head that was replaced.
a. Type the number 3 in the CYCLES field.
b. Press Enter.
c. Press the appropriate function key for the fluid:
F1: HM Wash Pump.
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3. Move the probe away from its reagent drain by turning the top shaft of
the R3 reagent arm if RMS is installed, or move the R2 reagent arm
counterclockwise. Turn off vacuum to Dimension® EXL ™ system.
4. From the main menu press: F7: Diagnostics > F1: Electromechanical >
F6: Waterworks. Press F4: Vacuum On/Off twice to turn vacuum off.
5. Clamp off non-labeled drain line directly at R2 or R3 drains (if installed)
using the supplied hemostats. Place a paper towel under the probe.
6. Using a disposable plastic pipette filled with 100% bleach or sample
probe cleaner, insert pipette tip into the drain near to the bottom and
dispense the bleach into the drain unit until it starts to overflow. Make
sure you have a paper towel around the drain to catch any overflow.
7. Remove the pipette and fill drain until it just overflows.
8. Let bleach sit in drain for 5 minutes.
9. Un-clamp drain lines.
10. Press F4: Vacuum On/Off to turn system vacuum back on.
11. Go to Prime Pumps screen and press F1: Prime Water (10x).
12. Record completion of this procedure in the Monthly Maintenance Log.
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Maintenance Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Other Maintenance
Only trained operators should perform these procedures.
The procedures described in this section are for maintenance that is required
periodically or for troubleshooting.
Accessory Spare Parts Kit
The replacement procedures use tools and commonly replaced parts that are
provided in your Accessory Spare Parts kit. After you use a spare part from this
kit, be sure to order a new one from Siemens.
Clot Check Bypass
4. Select F1: Clot Config to access the Clot Check Configuration menu.
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Maintenance Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
CAUTION: Using a prying motion may cause damage to the release plate.
CAUTION: When lowering the thermal chamber, ensure the waste tubing on
top of the waste bottle is clear before lowering completely.
Figure 7-21: Release Thermal Chamber
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4. Raise the IMT lid. Insert a long slender tool into the reagent lid latch.
Press firmly and raise the lid. Place the digital thermometer probe in the
fourth cuvette hole at the sample access position and place the
thermometer in the sample segment area.
Figure 7-26: IMT Lid Raised
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Maintenance Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
5. Close the IMT and reagent lids. Ensure that all instrument doors and
panels are closed.
6. Wait until the cuvette Thermal Signal Acquisition Interval field counts
down to 0 and changes to YES. If all other cuvette fields are also YES,
read the temperature on the digital thermometer.
a. If the cuvette temperature on the thermometer is between 32°C
and 42°C, continue with Step 7.
b. If it is outside this temperature range, do not enter the
temperature. Contact the Technical Solutions Center: Inside U.S.:
1-800-441-9250; Outside U.S. Refer to the local support team.
7. Lift the IMT and reagent lids and remove the digital thermometer probe
and sleeve from the cuvette access hole. Close the instrument lids. Press
the space bar on the keyboard and wait until all the cuvette fields display
YES.
8. Press F2: Calib Cuvette. Enter the temperature from the digital
thermometer and press Enter. The instrument will now make cuvette
thermal adjustments automatically.
Note: The temperature appears in the message area of the screen
as it is entered, not at the bottom of the Cuvette column on
the screen.
Calibrating Reagent System Temperature
Use the following to complete this procedure:
• Digital thermometer
1. Display the Cuvette/Reagent Temperature Monitor and Calibration screen
by pressing: F4: System Prep> F5: Temp Monitor.
2. Wait until the reagent Thermal Signal Acquisition Interval field displays
YES. Press F5: Check Reagent and answer the message that appears.
Wait for the message to place the temperature probe in position before
continuing.
3. Raise the IMT lid. Insert a long slender tool into the reagent lid latch.
Press firmly and raise the lid. Place the digital thermometer probe in the
reagent tray temperature measurement hole.
Figure 7-28: Probe Hole
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4. Close the reagent lid and ensure that all instrument doors and panels are
closed.
Figure 7-29: Digital Thermometer Probe
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Maintenance Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Calibrating HM Temperature
Use the following to complete this procedure:
• Digital thermometer
Note: The instrument must be turned on for more than two hours
before a proper temperature calibration can be performed.
1. Display the Cuvette/Reagent Temperature Monitor and Calibration screen
by pressing F4: System Prep > F5: Temp Monitor.
2. Press F3: Check HM Incu and type “y” in response to the instrument
warm up prompt.
3. When the message to place the temperature probe appears, insert a long
slender tool into the reagent lid latch. Press firmly and raise the lid.
4. Place the digital thermometer probe in the temperature monitoring hole
of the HM thermal ring. This small hole is in the inside rim of the heater
ring at the 6 o'clock position. The HM wheel cover has an arrow
indicating the position.
Figure 7-30: Temperature Probe
5. Wait three minutes for the temperature to equilibrate and then read the
temperature on the digital thermometer. If the temperature is between
34° C -39° C, continue with Step 6. If the temperature is outside this
range, call the Technical Solutions Center: Inside U.S.: 1-800-441-9250;
Outside U.S. Refer to the local support team.
6. Remove the digital thermometer probe.
7. Press F4: Calib HM Incu. Enter the temperature from the digital
thermometer and press Enter.
Note: If the message “The value entered is outside the allowed
calibration range” appears in the message area of the screen after
you press Enter, and the temperature you tried to enter is within
the 35°C to + 41.0°C temperature range, contact the Technical
Solutions Center: Inside U.S.: 1-800-441-9250; Outside U.S. Refer
to the local support team.
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Maintenance Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
the cuvette window and install a new window from the Accessory Spare
Parts kit.
Note: A window must be in each position on the cuvette ring. Use
replacements in the accessory spare parts kit. If no
replacements remain in the kit, put the damaged window
back in the instrument. Do not leave any empty hole in the
cuvette ring.
6. Press any key. Wait for the message “Clean and replace window, then
press any key to continue” to appear. The instrument automatically
advances nine window positions before the message appears.
7. Remove, clean, and reinstall the window. Press any key. Repeat this step
until all windows are cleaned.
8. When you have cleaned all the windows, and they have been determined
to be clean by the instrument, the message “All windows have
successfully passed QC” appear and window QC ranges are printed.
9. Close the reagent area lid.
10. Press Home or Shift/Exit to return to the Operating Menu. Press the
Reset key to initialize the instrument.
11. Record completion of this procedure in the Instrument Log.
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8. When you have cleaned all the dirty windows and all the windows are
determined to be clean by the instrument, the message “All windows
have successfully passed QC” appears and window QC ranges are printed.
9. Close the reagent lid.
10. Press Home or Shift/Exit to return to the Operating Menu. Press the
Reset key to initialize the instrument.
11. Record completion of this procedure in the Instrument Log.
Note: To configure custom window check limits, use the “Check Bad
Limit” field. Enter the limit for the software to use in
determining whether a window is acceptable to use. Values
in this field can be between 10 and 35. The default value is
15. (The lower the limit, the more windows that will require
cleaning during this check, but in general windows will need
to be cleaned less frequently). The system indicates windows
that do not meet the defined limit with red “x”s. These
windows will be presented for cleaning.
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2. Tilt the handle towards you to grip the window and hold it in place. Pull
the extractor up to remove the window.
Figure 7-33: Using Cuvette Window Extractor Tool
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Maintenance Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
# Description
1 Check Valve
2 Waste Tubing
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3. Place the waste tubing into the sample cup. The bleach should be drawn
out of the cup within 3–4 seconds. If it is not, repeat this step with
additional cups of bleach until it does.
Figure 7-37: Clean Waste Tubing
4. Fill a sample cup with water and place the waste tubing in the cup to
flush any residual bleach from the waste line.
5. Connect the waste tubing to the pump tubing.
6. Calibrate the IMT.
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9. Repeat Step 7 and Step 8 three times. When you are finished, do not
push the sample probe into the drain.
10. Follow the prompt "Remove cup from segment position then press any
key".
11. Close the instrument lids. Press the Reset key.
12. Record completion of these procedures in the Instrument Log.
Cleaning the Water Bottle
Use this procedure if you periodically change the water bottle and must then
clean the used water bottle.
Complete this procedure using the following supplies:
• 10% bleach solution
• Spare water bottle
1. Fill the used water bottle with a 10% bleach solution.
2. Let the solution stand in the bottle at least one hour.
3. Thoroughly rinse the bottle out and then allow it to air dry.
4. Cover the top of the bottle and store the bottle until the water bottle is
replaced again.
Replacing the Cuvette Diaphragm
Complete this procedure using the following tool:
• Diaphragm (included with film canister)
1. With the instrument in Standby, raise the IMT lid. Insert a long slender
tool into the reagent lid latch. Press firmly and raise the lid.
2. Display the System Counters screen by pressing:
F4: System Prep > F6: Sys Counters. Press F2: Diaph Change.
3. Locate the cuvette diaphragm.
Figure 7-39: Cuvette Diaphragm
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4. Raise the barcode reader and unscrew the alignment bar thumbscrew.
Raise the alignment bar out of the way.
5. Unlock the U-seal solenoid assembly by pulling its curved locking bar to
the right. Move the assembly to the left and out of the way.
Figure 7-41: Curved Locking Bar
# Description
3 U-Seal Solenoid
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6. Pull the cuvette formation assembly away from the cuvette ring.
7. Remove the used cuvette diaphragm by lifting an edge and pulling it up
off the heat torch.
Figure 7-42: Cuvette Diaphragm
CAUTION: Do not pull the soft tip out of position while replacing the
diaphragm.
8. Install the new cuvette diaphragm. The circular hole should be toward
the bottom of the heat torch. The U-shaped notches should face toward
you. Be sure the diaphragm is pushed down completely.
Figure 7-43: New Cuvette Diaphragm
9. Push the cuvette formation assembly back into position next to the
cuvette ring.
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10. Put the U-seal solenoid assembly in its original position. Lock it in place
with the curved bar.
11. Position the alignment bar and tighten its screw.
12. Lower the barcode reader.
13. Press any key. When the prompt “Do you want to store the NEW system
information? (y/n)” appears, type y to update the System Counters
screen.
14. Close the reagent and IMT lids.
15. Record completion of this procedure in the Instrument Log.
Replacing the Cuvette Film Cartridge
1. With the system in Standby, display the Film Loading/Tension screen by
pressing: F4: System Prep > F6: Sys Counters > F3: Film Load.
Figure 7-44: Film Loading/Tension Screen
2. Open the cabinet doors. Remove the waste container. See “Cuvette Film
Diagram” on page 31 of Chapter 11: Appendix.
3. Use scissors to cut the right and left film strips on the used cuvette
cartridge between the cartridge and the baseplate. Leave at least six
inches of film hanging from the instrument.
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Note: Cuvette diaphragms are also shipped with the cuvette film
cartridge. Place the diaphragms in the Accessory Spare Parts
Kit.
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# Description
1 Film
4 Film
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# Description
8. Press F1: Load Film. Wait for the counter to reset to 12,000 and for
movement to stop.
9. After film loading is complete, check to see that there is no slack in the
film coming out of the cuvette film cartridge. If there is, press
F2: Tension.
10. Insert the waste container and close the cabinet door.
11. Record completion of this procedure in the Instrument Log.
Replacing the Cuvette Formation Spring, Tip and E-Clip
Complete this procedure using the following tools:
• Screwdriver
• Needlenose pliers
1. With the instrument in Standby, raise the IMT lid. Insert a long slender
tool into the reagent lid latch. Press firmly and raise the lid.
2. Display the Cuvette Diagnostics screen by pressing
F7: Diagnostics > F1: Electro/Mech > F4: Cuvette.
3. Press F4: U-Seal Solenoid to de-energize the U-Seal Solenoid.
Note: The large, flat, round plate on the end of the solenoid valve
moves away (de-energizes) from the rounded portion of the
valve, and may release air as it de-energizes.
4. Raise the barcode reader. Unscrew the alignment bar thumbscrew and
raise the alignment bar.
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5. Unlock the U-seal solenoid assembly by pulling its curved locking bar to
the right. Move the assembly to the left away from the cuvette ring.
Figure 7-50: Curved Locking Bar
# Description
3 U-Seal Solenoid
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6. Pull the spring toward the form plunger head and separate it from the
E-ring. Move the E-ring and plunger shaft slightly toward the spring (but
still separate from the spring). Use the needlenose pliers to pull out the
E-ring.
Figure 7-51: E-Ring
# Description
1 Plunger Shaft
2 Cuvette Diaphragm
3 E-Ring
7. Remove the cuvette diaphragm by lifting an edge and pulling it up off the
heat torch.
8. Remove the plunger shaft/tip from the form block.
Figure 7-52: Plunger Shaft
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Maintenance Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
9. If you are replacing the spring only, skip to Step 11. Otherwise, remove
the old soft tip from the plunger head. If the tip is broken, be sure to
remove the remaining part of the tip. Do not scratch the plunger head.
10. Install a new rubber tip on the plunger head. Make sure the bottom of
the rubber tip is flush with the plunger head. The bump on the rubber tip
should rest in the small cavity inside the metal plunger slot. If it does not,
use a small screwdriver to push it into position as shown below. Skip to
Step 16.
Figure 7-53: Plunger Head
# Description
2 Rubber Tip
11. Remove the old spring and place a new spring in the middle of the form
block.
12. Install the plunger shaft. Push the spring toward the plunger head and
away from the groove on the shaft.
13. Push the plunger forward slightly to expose the groove.
14. Install the E-ring, making sure not to crush the spring.
15. Replace the cuvette diaphragm. See “Replacing the Cuvette Diaphragm”
on page 39 of this chapter.
16. Reposition the U-seal solenoid near the cuvette ring and push the curved
locking bar into place.
17. Position the alignment bar and tighten its thumbscrew.
18. Lower the barcode reader.
19. Close the instrument lids. At the Cuvette Diagnostic screen, enter 20 and
press Enter. Press F1: Cycle to make 20 cuvettes.
20. Record completion of this procedure in the Instrument Log.
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6. Grip the sensor firmly and pull it straight down off its spring clip and post
and then disconnect P/J 32B.
7. Install the new cuvette ring sensor. Push the sensor completely up until it
snaps into place.
8. Raise the thermal chamber.
9. Restore power to the instrument following “Restoring Power After a
Controlled Shutdown” on page 8 of Chapter 2: Safety and Specifications
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# Description
1 Hexagonal Standoff
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Replacing AC Fuses
The AC fuse panel is located on the left side of the instrument.
1. Power down the instrument. See “Performing a Controlled Power
Shutdown” on page 7 of Chapter 2: Safety and Specifications.
2. Lift the printer shelf.
3. Using a screwdriver, turn the fuse holder to the left (counterclockwise) to
release the fuse from the instrument.
Figure 7-58: Fuse Panel
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Maintenance Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Replacing DC Fuses
1. Power down the instrument. See “Performing a Controlled Power
Shutdown” on page 7 of Chapter 2: Safety and Specifications.
2. Open the left front cabinet door. Locate the two vertical rows of fuses on
the card cage.
Figure 7-59: DC Fuses
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4. Unlock the U-seal solenoid assembly by pulling its curved locking bar to
the right. Move this assembly to the left and out of the way.
Figure 7-61: Curved Locking Bar
# Description
3 U-Seal Solenoid
5. Pull the cuvette formation assembly away from the cuvette ring.
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# Description
2 Screw
4 P/J13K
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9. Remove the screw that holds the heat torch assembly. Remove the heat
torch assembly from the instrument.
Figure 7-63: Torch Assembly
# Description
1 Screw
2 Assembly Removed
10. Install the new heat torch assembly by reversing the previous steps.
Note: The circular holes should face toward the bottom of the
cuvette diaphragm. The u-shaped notches should face
forward. Be sure the diaphragm is pushed down completely.
11. Restore power to the instrument following “Restoring Power After a
Controlled Shutdown” on page 8 of Chapter 2: Safety and Specifications.
12. Perform a System Check.
13. Record completion of this procedure in the Instrument Log.
Replacing the HM Incubate Wheel or Wash Wheel Home Sensor
Complete this procedure using the following tools:
• Screwdriver
• 9/64 T-handle Allen wrench
1. Power down the instrument. See “Performing a Controlled Power
Shutdown” on page 7 of Chapter 2: Safety and Specifications.
2. Raise the IMT lid. Insert a long slender tool into the reagent lid latch.
Press firmly and raise the lid.
3. Using a screwdriver, remove the bottom plastic guard from the wash
station. The two screws on the guard only need to be loosened until the
guard can be slid from underneath them.
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WARNING: All reaction vessels removed from the wash wheel and
incubate wheel are biohazards. Dispose of them according to
your laboratory’s safe biohazard disposal procedures.
6. Unscrew the wash wheel locking knob and then use the knob to lift the
wash wheel out of the instrument.
Figure 7-64: HM Tower
# Description
2 Probe Thumbscrew
4 Wash Wheel
5 Incubate Wheel
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# Description
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WARNING: All reaction vessels removed from the wash wheel and
incubate wheel are biohazards. Dispose of them according to
your laboratory’s safe biohazard disposal procedures.
6. Unscrew the wash wheel locking knob. Use the knob to lift the wash
wheel out of the instrument.
Figure 7-66: HM Tower Wash Wheel
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8. Using a 9/64 T-handle Allen wrench, remove the three screws that hold
the magnet ring in the instrument. Lift the magnet ring out of the
instrument.
Figure 7-67: Magnet Ring Screws
9. Using a screwdriver, remove the two screws that hold the mixer
assembly sensor board to the mixer assembly.
Figure 7-68: Mixer Assembly Screws
# Description
1 Mixer #2
2 Mixer # 1
10. Lift the sensor board up until you can disconnect electrical connector
P/J 44B and remove the sensor board from the instrument.
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Figure 7-69: Wash Station Insert a long slender tool and raise
the IMT and reagent lids.
Figure 7-70: Pump Panel Open the front cabinet doors and the
pump panel.
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3. Disconnect the top and bottom tubing from the pump head at its
connectors.
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a. Insert the shipping plug (or “T”) that came with the pump head
completely into the front of the pump head.
b. Slide the pump head onto the shaft of the motor.
c. Reattach the tubing to the pump head.
CAUTION: The shipping plug (“T”) must be inserted into the pump head
before installing onto the motor to prevent damage to the pump
rollers as the pump head is pushed onto the motor shaft.
7. Install the new HM pump and motor assembly.
a. Insert and tighten two screws.
b. Connect the motor electrical connector.
c. Connect the tubing to the pump head.
8. Restore power to the instrument following “Restoring Power After a
Controlled Shutdown” on page 8 of Chapter 2: Safety and Specifications.
9. Prime the pump on the assembly that was replaced.
a. Display the Pump Prime screen by pressing:
F4 System Prep > F7: Pump Prime > F6: HM...
b. Type the number 3 in the CYCLES field.
c. Press Enter.
d. Prime the pump and motor assembly that was replaced by pressing
on one of the following:
1) F1: HM Wash Pump (chemistry wash)
2) F2: Reag Cleaner (reagent cleaner)
3) F3: Samp Cleaner (sample cleaner)
Note: If the wash station pump or motor assembly was replaced,
prime the chemistry wash. If the left pump motor assembly
on the pump panel was replaced, prime the reagent cleaner.
If the right pump and motor assembly on the pump panel,
prime the sample cleaner.
10. Perform a System Check.
11. Record completion of this procedure in the Instrument Log.
Replacing the HM Shuttle Home Sensor
Use the following tool to complete this procedure:
• Screwdriver
1. Power down the instrument. See “Performing a Controlled Power
Shutdown” on page 7 of Chapter 2: Safety and Specifications.
2. Using a screwdriver, remove the screw that holds the shuttle home
sensor to the instrument.
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# Description
2 P/J 48 E
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# Description
1 Cable Clamp
3. Using a 9/64 Allen wrench, remove the screw on the clamp that holds the
electrical cable for the switch.
4. Unplug electrical connector P/J 48C from the Vessel Transfer PC board.
Remove the vessel detect switch from the instrument.
5. Install the new vessel detect switch and reconnect P/J 48C.
6. Restore power to the instrument following “Restoring Power After a
Controlled Shutdown” on page 8 of Chapter 2: Safety and Specifications.
7. Perform a System Check.
8. Record completion of this procedure in the Instrument Log.
Replacing an HM Wash Probe
1. With the system in Standby, display the HM Pump Prime screen by
pressing: F4: System Prep > F7: Pump Prime > F6: HM...
Note: Navigating to the HM Pump Prime screen prevents any
automatic priming of the HM wash probes that may occur.
This is also the correct screen to prime the probes later in this
procedure.
2. Raise the IMT and reagent lids.
3. Disconnect the tubing from the wash probe.
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# Description
2 Probe Thumbscrew
4. Loosen the probe thumbscrew until you can lift the probe up and out of
the wash station. Discard the probe.
5. Position the new wash probe in the wash station so that its dispense
probe is toward the front edge of the wash station. Gently push the
probe all the way down until its lip contacts the probe holder.
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8. Align the wash probe to the wash wheel by completing the following
steps:
a. Display the HM Module Alignments screen from the Operating
Menu by pressing:
F7: Diagnostics > F3: Alignments > F6: HM Module.
b. Move the cursor to the Wash Probes to Wash Wheel field.
c. Press F7: Check Align.
Note: For more information, see “HM Module Alignments” on
page 8 of Chapter 8: Alignments.
9. Perform a System Check.
10. Record completion of this procedure in the Instrument Log.
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# Description
4. Using a flat blade screwdriver, remove the two screws that hold the
vacuum sensor tower to the station.
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5. Set the vacuum sensor tower to the side of the wash station as shown by
allowing it to hang.
CAUTION: Use caution when setting the tower aside so as not to disconnect
any tubing or electrical connections.
Figure 7-78: Vacuum Sensor
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6. Using a 5/64 Allen wrench, remove the screw that holds the wash probe
home sensor in the instrument.
7. Disconnect electrical connector P/J 45B. Remove the sensor from the
instrument.
8. Install the new wash probe home sensor. Reconnect P/J 45B.
9. Restore power to the instrument following “Restoring Power After a
Controlled Shutdown” on page 8 of Chapter 2: Safety and Specifications.
10. Align the wash probes to the wash wheel by completing the following
steps:
a. Display the HM Module Alignments screen from the Operating
Menu by pressing:
F7: Diagnostics > F3: Alignments > F6: HM Module.
b. Move the cursor to the Wash Probes to Wash Wheel field.
c. Press F7: Check Align.
Note: For more information, see “HM Module Alignments” on
page 8 of Chapter 8: Alignments.
11. Perform a System Check.
12. Record completion of this procedure in the Instrument Log.
Replacing HM Wash Probe Tubing
1. With the system in Standby, display the HM Pump Prime screen by
pressing: F4: System Prep > F7: Pump Prime > F6: HM...
Note: Navigating to the HM Pump Prime screen prevents any
automatic priming of the HM wash probes that may occur.
This is also the correct screen to prime the probes later in this
procedure.
2. Raise the IMT and reagent lids.
3. Disconnect and discard the following pieces of tubing.
Blue 2 (short) Wash Probe 2 aspirate (bent top) probe and vacuum sensor
Green 4 (short) Wash Probe 1 aspirate (bent top) probe and vacuum sensor
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WARNING: All reaction vessels removed from the wash wheel and
incubate wheel are biohazards. Dispose of them according to
your laboratory’s safe biohazard disposal procedures.
5. Unscrew the wash wheel locking knob. Use the knob to lift the wash
wheel out of the instrument.
6. Install the new wash wheel.
a. Place any of the three alignment holes in the wash wheel onto the
wash wheel alignment pin and push the wash wheel onto the
instrument.
b. Tighten the wash wheel locking knob.
c. Reinstall the HM cover.
d. Reinstall the guard onto the wash station.
7. Press Pause to restart sampling system.
8. Display the HM Module Alignments screen from the operating menu by
pressing: F7: Diagnostics > F3: Alignments > F6: HM Module.
a. Perform the three incubate and wash wheel alignments located in
the top half of the HM Module Alignments screen. For more
information, see “HM Module Alignments” on page 8 of Chapter 8:
Alignments.
9. Perform a System Check.
10. Record completion of this procedure in the Instrument Log.
Replacing IMT Miscellaneous Tubing
Complete this procedure using the following tool:
• 3/32 Allen wrench
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4. Refer to the label on the instrument lid to identify where tubing is located
within the IMT system. See the following pages for how to replace each
piece of tubing. The tubing to be replaced is labeled: R1, D1, D2, F1, F2,
X2, X3, W2, and Waste.
WARNING: The X2, X3, W2, and Waste tubing are biohazards. Follow your
laboratory’s safe biohazard waste disposal procedures to
discard this tubing.
5. After replacing all the tubing, return the QuikLYTE® multisensor interface
to its locked, upright position.
6. Press the Pause key. Prime the IMT system with Salt Bridge solution.
7. Run a condition/soak cycle.
8. Calibrate the IMT.
9. Record completion of this procedure in the Instrument Log.
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IMT Tubing
Figure 7-81: IMT Tubing Diagram
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Tubing Replacement
• 1: R1 attaches here
• 2: X1 attaches here
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Tubing Replacement
W 1. Using the 3/32 Allen wrench, remove the two screws that hold the IMT
port to the baseplate and lift the IMT port up until its solenoid valve is
accessible.
2. Disconnect and replace W2. W2 connects position 2 on the valve to the
bottom of the IMT port.
3. Reinstall the IMT port onto the baseplate using the two holes noted in
Figure 7-83.
4. Perform Sample Probe to the IMT Port Alignment. See “Sample Probe to
the IMT Port Alignment” on page 39 of Chapter 8: Alignments.
X3 Disconnect and replace this tubing. X3 Connects the IMT Pump to the filter
T-fitting.
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Tubing Replacement
Waste Disconnect and replace this tubing. The waste tubing connects to the waste
bottle inside the instrument cabinet.
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6. Lift the rotary valve motor off the valve body. Turn it over and remove
the rotary valve seal from the valve seal holder on the encoder assembly.
7. Press down firmly on the encoder assembly and ensure that it springs
back with a click sound. If it does not, contact the Technical Solutions
Center: Inside U.S.: 1-800-441-9250; Outside U.S. Refer to the local
support team.
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# Description
1 Motor
2 Encoder Assembly
3 Valve Seal
5 Valve Body
8. Clean the inside of the valve body with a gauze pad lightly moistened
with water.
9. Lubricate the new rotary valve seal with Krytox® grease. Place a
pinhead-sized drop of grease on your gloved forefinger. Gently rub your
gloved forefinger and thumb together, then rub both sides of the seal
between your thumb and forefinger.
CAUTION: Do not apply too much grease to the valve seal. The grease can
clog the slot opening in the seal.
10. Install the new rotary valve seal with the flat side against the valve seal
holder on the valve motor assembly. The X and the slot on the seal
should be visible.
11. Reinstall the motor assembly into the valve body using the four screws or
posts. Completely tighten these four screws using the needlenose pliers.
12. Reconnect the tubing to the Standard A and Standard B bags.
13. Prime Standard A, Standard B, and the Flush solution.
14. Calibrate the IMT.
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5. Using needlenose pliers, remove four screws or four posts at each corner
in the top of the IMT rotary valve.
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# Description
1 Motor
3 Valve Body
7. Using the 3/32 Allen wrench, remove two screws that secure the sensor
to the IMT Rotary Valve body.
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# Description
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4. Using the screwdriver, loosen the three captive screws that secure the R2
reagent arm to the instrument. (Move the R2 arm counterclockwise to
access and loosen captive screw number 3.)
5. Carefully lift the R2 reagent arm and set it aside. You do not need to
disconnect any tubing or electrical connectors.
Figure 7-95: R2 Reagent Arm Alignment Pin
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Note: The optical filter wheel has 10 filter positions that are
numbered at the center of the wheel. The wavelength of the
optical filter for each position is shown in the illustration.
7. Carefully lift the edge of the filter and remove it from the wheel. Holding
the filter by its sides, clean both surfaces with lens paper. If necessary,
use water to clean the filter.
CAUTION: Do not use paper towels to clean optical filters; they will damage
the filters by scratching them.
Figure 7-97: Optical Filters
8. Reinsert the filter into its correct position in the filter wheel. The arrow
on the side of the filter should point up. Then wipe the top surface of the
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optical filter with lens paper. Also wipe the top of any other filters you
may have touched inadvertently while inserting the filter.
WARNING: Make sure that the filter is replaced with the arrow pointing
up or it will not function properly.
Figure 7-98: Optical Filter
9. Position the alignment slot in the R2 reagent arm over the alignment pin
in the instrument baseplate. Tighten the captive screws. Reinstall the R2
reagent arm.
10. Restore power to the instrument following “Restoring Power After a
Controlled Shutdown” on page 8 of Chapter 2: Safety and Specifications.
11. Perform the R2 Reagent Probe Alignments procedure. See “R2 Reagent
Probe Alignments” on page 25 of Chapter 8: Alignments.
12. Perform a System Check.
13. Record completion of this procedure in the Instrument Log.
Note: You may want to confirm method performance by processing
QC samples for those methods that use the filter(s)
replaced/cleaned. See the method specific IFU for detailed
information on appropriate filters.
Replacing the Photometer Filter Wheel Dual Sensor
Complete this procedure using the following tool:
• Screwdriver
1. Power down the instrument. See “Performing a Controlled Power
Shutdown” on page 7 of Chapter 2: Safety and Specifications.
2. Raise the IMT lid. Insert a long slender tool into the reagent lid latch.
Press firmly and raise the lid.
3. Turn the bottom splined shaft on the R2 reagent arm to raise the reagent
probe out of the drain.
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4. Using the screwdriver, loosen the three captive screws that secure the R2
reagent arm to the instrument. (Move the R2 arm counterclockwise to
access and loosen captive screw number 3.)
5. Carefully lift the R2 reagent arm and set it aside. You do not need to
disconnect any tubing or electrical connections.
Figure 7-100: R2 Reagent Arm Alignment Pin
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6. Unplug P/J 34C. Remove the screw in the center of the S1 sensor and
remove the sensor from the instrument.
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# Description
1 R1 Reagent Arm
6. Install the new photometer home sensor and the R1 reagent arm by
reversing the previous steps.
7. Restore power to the instrument following “Restoring Power After a
Controlled Shutdown” on page 8 of Chapter 2: Safety and Specifications.
8. Perform Step 1 through Step 6 of the Photometer Alignment procedure.
See “Photometer Alignment ” on page 19 of Chapter 8: Alignments.
9. Perform a System Check and Daily QC.
10. Record completion of this procedure in the Instrument Log.
Replacing Printer Paper
1. Push the Cover Open lever on the right side of the printer. Lift the cover.
2. Remove any remaining paper.
3. Position the new paper roll so the paper comes out from the bottom. Pull
the leading edge of the paper over the front of the printer.
4. Push down both sides of the printer cover until you hear a click. If power
is on, the printer automatically advances and cuts the paper.
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# Description
3 Thumbscrew
6 HM (2500 µL)
Note: Synonyms used for these pumps: the 100 µL and 500 µL
pumps are also called metering or small pumps; the 2500 µL
pumps are also called flush or large pumps.
3. Remove the plastic shield on the rear of the pump assembly by loosening
the captive screw at the top of the shield.
4. Locate the sensor to be replaced and disconnect its connector.
5. Use the 5/64 hex wrench to remove the hex screw holding the sensor to
its bracket. Remove and discard the sensor.
6. Install the optical sensor on the bracket using the 2-56 x.25 hex screw.
Do not replace the plastic shield.
CAUTION: Do not overtighten the screw - you could damage the sensor.
7. Plug the optical sensor into the connector.
8. Check the syringe gap between the bottom of the syringe and the top of
the metal plunger using a folded piece (equal to four thicknesses) of
printer paper. This will set a gap of 0.005–0.010 inches. If the gap setting
is correct, you should be able to just barely slide this paper between the
bottom of the syringe and thetop of the metal plunger.
a. If the setting is correct, skip to Step 16.
b. If the setting needs adjustment, continue with Step 9.
9. Manually turn the pump lead screw in the direction shown in
Figure 7-104 until it cannot be turned any further.
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# Description
1 Optical Sensor
2 Locking Nut
3 Adjustment Screw
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11. Turn the adjustment screw until the syringe indicator light (LED) on the
front panel of the appropriate Motor Control Board in the card cage just
lights.
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# Description
1 Solenoid Valve A
2 Solenoid Valve C
3 Solenoid Valve B
4 Solenoid Valve F
5 Solenoid Valve D
6 Solenoid Valve G
7 Solenoid Valve E
8 Solenoid Valve H
6. Display the Pump Prime Menu screen and prime the appropriate pump.
a. From the Operating Menu, press:
F4: System Prep > F7: Pump Prime.
b. Move the cursor to the Cycles field and type 6 for the number of
cycles to be performed.
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c. Press the appropriate function key to begin priming the pump for
the solenoid valve that was replaced.
d. While priming, check for any tubing leaks. Continue priming the
pump until all the air is out of its tubing.
7. Perform a System Check and your Daily QC.
8. Record completion of this procedure in the Instrument Log.
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# Description
3 Thumbscrew
6 HM (2500 µL)
3. Remove the thumbscrew from the bottom bracket of the syringe. Use the
needlenose pliers to keep the syringe plunger from turning as you
unscrew this thumbscrew.
CAUTION: Use the needlenose pliers on the metal part of the syringe
plunger. Do not use pliers on the glass part of the syringe.
4. Press the pump assembly release button and pull the pump assembly
toward you.
5. Remove the plastic shield on the rear of the pump assembly by loosening
the captive screw at the top of the shield.
6. Manually turn the syringe’s pump lead screw in the direction shown in
Figure 7-109 until it cannot be turned any further.
Figure 7-109: Pump Lead Screws
7. Using the 7/64 Allen wrench, remove the screw from the top bracket of
the syringe.
8. Fit the new syringe into the upper bracket and loosely tighten the 7/64
Allen screw in the upper bracket.
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9. Pull the plunger down until it is snug in the bottom syringe bracket, then
completely tighten the thumbscrew. Use needlenose pliers to keep the
syringe plunger from turning as you tighten the thumbscrew with your
fingers.
CAUTION: Use the needlenose pliers on the metal part of the syringe
plunger. Do not use pliers on the glass part of the syringe.
10. Completely tighten the 7/64 Allen screw at the top of the syringe bracket.
11. Display the Pump Prime Menu screen and prime the appropriate pump.
a. From the Operating Menu, press:
F4: System Prep > F7: Pump Prime.
b. Move the cursor to the Cycles field and type 6 for the number of
cycles to be performed.
c. Press the appropriate function key to begin priming the pump for
the solenoid valve that was replaced.
d. While priming, check for any tubing leaks. Continue priming the
pump until all the air is out of its tubing.
12. Check the syringe gap between the bottom of the syringe and the top of
the metal plunger using a folded piece (equal to four thicknesses) of
printer paper. This will set a gap of 0.005–0.010 inch. If the gap setting is
correct, you should be able to just barely slide this paper between the
bottom of the syringe and thetop of the metal plunger.
a. If the gap setting is correct, skip to Step 19.
b. If a gap adjustment is required, continue with Step 13.
Figure 7-110: Syringe
# Description
1 Plunger
2 Syringe
3 Foot of Plunger
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13. Turn the pump lead screw in the direction shown in the illustration below
until it cannot be turned any further.
Figure 7-111: Lead Screws
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18. Using the 3/32 Allen wrench to keep the adjustment screw from turning,
tighten the locking nut using the 11/32 wrench.
After tightening this nut, perform another prime. Make a final check of
the gap to ensure that it did not move while you tightened the locking
nut. Continue with step 20.
19. Replace the shield on the rear of the pump assembly. Close the assembly.
20. Display the Pump Prime Menu screen and prime the appropriate pump.
a. From the Operating Menu, press:
F4: System Prep > F7: Pump Prime.
b. Move the cursor to the Cycles field and type 6 for the number of
cycles to be performed.
c. Press the appropriate function key to begin priming the pump for
the solenoid valve that was replaced.
d. While priming, check for any tubing leaks. Continue priming the
pump until all the air is out of its tubing.
21. Perform a System Check and your Daily QC.
22. Record completion of this procedure in the Instrument Log.
Replacing a Reagent Arm Radial Home Sensor
Complete this procedure using the following tools:
• Screwdriver
• 3/32 Allen wrench
The reagent arm radial home sensor is located midway along the reagent arm.
1. With the instrument in Standby, press the Pause key to stop the sampling
system.
2. Raise the IMT lid. Insert a long slender tool into the reagent lid latch.
Press firmly and raise the lid.
3. Turn the bottom splined shaft on the reagent arm to raise the reagent
probe out of the reagent drain.
4. Move the probe away from its reagent drain (by turning the top shaft of
the R1 reagent arm or moving the R2 reagent arm counterclockwise)
until you can easily access the sensor.
5. Disconnect P/J 20C for R1 (or P/J 80D for R2).
6. Using a screwdriver, remove the screw that holds the radial home sensor
to the reagent arm. Remove the sensor.
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CAUTION: Be careful not to damage any other connectors when cutting tie
wraps. Reapply new tie wraps from the Accessory Spare Parts Kit
after installing the new sensor. To locate the sensors on a reagent
arm, use the yellow and black wires as a guide to the sensor.
7. Install the new sensor by reversing the previous steps. Position the R1
sensor with the yellow and black wires at the top.
8. Press the Pause key to restart the sampling system.
9. Perform all the reagent arm alignments for the probe on which the
sensor was replaced. See “R1 Reagent Probe Alignments” on page 20 of
Chapter 8: Alignments. See “R2 Reagent Probe Alignments” on
page 25 of Chapter 8: Alignments. See R3 Probe Alignments in the RMS
Operator’s Guide.
10. Close the instrument lids.
11. Perform a System Check.
12. Record completion of this procedure in the Instrument Log.
Replacing a Reagent Arm Vertical Home Sensor
Complete this procedure using the following tools:
• Screwdriver
• 3/32 Allen wrench
The reagent arm vertical home sensor is located at the probe end of the
reagent arm.
1. With the instrument in Standby, press the Pause key to stop the sampling
system.
2. Raise the IMT lid. Insert a long slender tool into the reagent lid latch.
Press firmly and raise the lid.
3. Turn the bottom splined shaft on the reagent arm to raise the reagent
probe out of the reagent drain.
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4. Move the probe away from its reagent drain (by turning the top shaft of
the R1 reagent arm or moving the R2 reagent arm counterclockwise)
until you can easily access the sensor.
5. Disconnect P/J 20D for R1 or P/J 80B for R2.
Figure 7-113: Vertical Home Sensor
# Description
2 Cable Holder
CAUTION: Be careful not to damage any other connectors when cutting tie
wraps. Reapply new tie wraps from the Accessory Spare Parts Kit
after installing the new sensor.
6. Using a screwdriver, remove the screw that holds the vertical sensor to
the sensor housing bracket and remove the sensor from the reagent arm.
7. Install the new sensor by reversing the previous steps. Make sure the
sensor cable is placed into its cable holder. Close the instrument lids.
8. Press the Pause key to restart the sampling system.
9. Perform all the reagent arm alignments for the probe on which the
sensor was replaced. See “R1 Reagent Probe Alignments” on page 20 of
Chapter 8: Alignments. See “R2 Reagent Probe Alignments” on
page 25 of Chapter 8: Alignments.
10. Close the instrument lids.
11. Perform a System Check.
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4. Move the probe away from its reagent drain (by moving the R2 reagent
arm counterclockwise) until you can easily access the sensor.
5. Disconnect P/J 32D.
6. Using a screwdriver, remove the screw that holds the sensor to its
bracket. Remove the sensor from the instrument.
Figure 7-114: Rotational Home Sensor
7. Separate the metal clip from the old sensor and place it on the new
sensor.
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# Description
1 Metal Clip
2 Sensor
3 Bracket
8. Install the sensor by reversing the previous steps. Close the instrument
lids.
9. Press the Pause key to restart the sampling system.
10. Perform all the R2 reagent arm alignments. See “R2 Reagent Probe
Alignments” on page 25 of Chapter 8: Alignments.
11. Close the instrument lids.
12. Perform a System Check.
13. Record completion of this procedure in the Instrument Log.
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# Description
1 Ratchet Wrench
2 Offset Wrench
3 Open-End Wrench
1. With the instrument in Standby, press the Pause key. Raise the IMT and
reagent lids.
2. Turn the bottom splined shaft on the reagent arm to raise the reagent
probe out of the reagent drain.
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3. Move the probe away from its reagent drain (by turning the top shaft of
the R1 reagent arm or moving the R2 reagent arm counterclockwise)
until you can easily access its reagent probe tip.
4. Place a paper towel under the probe to prevent anything from falling into
a reagent cartridge while you are removing the probe tip.
5. Remove the probe tip and nut. You can remove the probe tip and nut by
using the 5/16 wrench with either the offset wrench or the ratchet
wrench.
a. Using the 5/16 wrench and the offset wrench:
1) Place the 5/16 wrench on the reagent probe body to keep it
from turning.
2) Slide the 1/4 end of the offset wrench up the reagent probe
and onto the probe tip nut.
3) Turn the offset wrench clockwise to loosen the probe tip nut.
Once loose, unscrew it with your fingers to remove the probe
tip and nut.
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# Description
1 Open-end Wrench
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# Description
1 Open-End Wrench
6. Insert a new reagent probe tip into a new probe tip nut. Screw the new
reagent probe tip onto the reagent probe body finger-tight.
Figure 7-120: Reagent Probe Tip
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# Description
1 Reagent Probe
2 Nut
7. Completely tighten the new reagent probe tip using the 5/16 open-end
wrench with offset wrench or ratchet wrench.
a. Using the ratchet wrench to tighten the probe tip:
1) Place the 5/16 wrench on the reagent probe body to keep it
from turning.
2) With the “Off” marking on the ratchet wrench facing up, slide
the 1/4 opening of the ratchet wrench up the reagent probe
and onto the probe tip nut.
3) Turn the ratchet wrench counterclockwise to completely
tighten the probe tip and nut to the probe body.
8. Close the instrument lids and press Pause to restart the sampling system.
9. Display the System Counters screen from the operating menu by
pressing: F4: System Prep > F7: Pump Prime.
10. Move the cursor box to the appropriate reagent probe tip field, and press
Enter to change the field from NO to YES. Press F1: Store Changes.
11. Prime the reagent pump by:
a. From the operating menu by pressing:
F4 System Prep > F7: Pump Prime.
b. Move the cursor to the Cycles field and type 3 for the number of
cycles to be performed.
c. Press the appropriate function key to begin priming the reagent
pump for the tip that was replaced.
12. Perform the Reagent Probe Alignments procedures,
see Chapter 8: Alignments
13. Perform your Daily QC.
14. Record completion of this procedure in the Instrument Log.
Replacing the Reagent Tray Home Sensor
Complete this procedure using the following tools:
• Screwdriver
• 9/64 Allen wrench
• 5/32 Allen wrench
1. Power down the instrument. See “Performing a Controlled Power
Shutdown” on page 7 of Chapter 2: Safety and Specifications.
2. Raise the IMT lid. Insert a long slender tool into the reagent lid latch.
Press firmly and raise the lid.
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3. Disconnect the two reagent tray drive motor connectors, P/J 50G and
P/J 3C. Remove all tubing clamps from the reagent tray drive bracket.
Figure 7-121: Reagent Tray Home Sensor
# Description
2 Bar
3 Tubing Clamps
4. Using the 9/64 Allen wrench, loosen the four screws that secure the drive
motor to its bracket. Slide the drive motor toward the front of the
instrument to disengage its gears.
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# Description
1 Motor Screws
2 Allen Screws
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# Description
1 Springbar
2 Sensor
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3. Open the front cabinet doors and remove the reagent tubing from the
left port of the reagent arm 500 µL syringe by pulling on the knurled
fitting. Unscrew the knurled fitting from the tubing. Save this knurled
fitting because you will be installing it on the new tubing later in this
procedure.
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# Description
1 Knurled Fitting
2 500 µL Syringe
Note: The knurled fittings in Step 3 and Step 4 are not the same.
The knurled fitting at the pump end of the sample tubing is
larger (and has a larger collar) than the knurled fitting at the
probe end. Be sure that you place the correct knurled fitting
onto the proper end of the tubing. This procedure will remind
you of this in later steps.
4. Disconnect the reagent tubing from the reagent probe by pulling on the
probe knurled fitting. Then unscrew the knurled fitting from the tubing
and pull the tubing through the spring guide. Save this knurled fitting,
because it is installed on the new tubing later in this procedure.
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# Description
1 Spring Guide
2 Knurled Fitting
5. Remove the tubing from tubing clamps or guides as necessary and pull it
up through the instrument. Discard the tubing.
6. Start from the reagent probe and thread the new tubing down through
the instrument to the reagent pump. Thread through tubing clamps and
guides as necessary.
a. Position the black wrappings (or stamped markings) on the reagent
tubing as shown in Figure 7-128.
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# Description
1 R2 Tubing
2 Tubing Clamps
3 R1 Tubing
4 Tubing Guide
5 Spring Clamp
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# Description
1 R1 Tubing
2 R2 Tubing
7. Attach the knurled fitting removed from the old tubing in Step 3 to the
pump end of the new tubing by screwing the fitting on by hand until
approximately 1/16 inch (1.5 mm) of the tubing extends past the fitting.
Press the tubing onto the 500 µL reagent syringe fitting.
Figure 7-130: 1/16” of Tubing
8. Install the new reagent tubing through the spring guide and onto the
reagent probe. Position the reagent tubing through the spring guide as
shown in Figure 7-131. To install the reagent tubing through the spring
guide:
a. Pull the tubing through the spring guide to position the black
wrapping (or stamped marking) as shown in Figure 7-131.
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# Description
1 Spring Guide
2 Metal Fitting
3 Knurled Fitting
4 2.25 Inches
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# Description
1 Ratchet Wrench
2 Offset Wrench
3 Open-End Wrench
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4. Remove the probe tip and nut using the 5/16 open-end wrench with
either the offset wrench or the ratchet wrench:
a. Using the 5/16 Open-End Wrench and the Offset Wrench:
1) Place the 5/16 wrench on the sample probe body to stabilize it
and prevent it from turning.
2) Slide the 1/4 end of the offset wrench up the sample probe
and onto the probe tip nut.
3) Turn the offset wrench clockwise to loosen the probe tip nut.
Once loose, unscrew it with your fingers to remove the probe
tip and nut.
Figure 7-134: Sample Probe and Offset Wrench
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5. Insert a new sample probe tip into a new probe tip nut and screw it onto
the sample probe body finger-tight.
6. Completely tighten the new sample probe tip using the 5/16 open-end
wrench with offset wrench or ratchet wrench.
a. To use a ratchet wrench to tighten the probe tip:
1) Place the 5/16 wrench on the sample probe body to keep it
from turning.
2) With the “OFF” marking on the ratchet wrench facing upward,
slide the 1/4 opening of the ratchet wrench up the reagent
probe and onto the probe tip nut.
3) Turn the ratchet wrench counterclockwise to completely
tighten the probe tip and nut to the probe body.
7. Close the instrument lids and press the Pause key to restart the sampling
system.
8. Display the System Counters screen from the Operating Menu by
pressing: F4: System Prep > F6: Sys Counters. Move the cursor box to
the Sample Probe Tip field.
9. Press Enter to change the field from NO to YES. Press F1: Store
Changes.
10. Prime the sample pump by:
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1. With the instrument in Standby, press the Pause key to stop the sampling
system.
2. Raise the IMT lid. Insert a strong slender tool into the reagent lid latch.
Press firmly and raise the lid.
3. Open both instrument doors and pull the sample tubing off the left port
of the 100-µL syringe.
Figure 7-136: Syringe Left Port
# Description
1 Left Port
2 To Sample Probe
3 100 µL Syringe
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4. Remove the plastic fitting from the end of this tubing. Keep it to place on
the new sample tubing later in this procedure.
5. Gently pull out on the sides of the sample cover and lift it off the probe
assembly.
Figure 7-137: Sample Cover Probe Assembly
6. Remove the sample tubing from the sample probe connection and pull
the tubing up through the instrument.
7. Press the black sheathed end of the new sample tubing onto the sample
probe connection.
8. Route the other end of the sample tubing down through the corrugated
black plastic conduit until it comes out the opening above the 100-µL
syringe.
9. Attach the plastic fitting onto the sample tubing and press the tubing
onto the left port of the 100-µL syringe.
10. Close the instrument lids and press the Pause key to turn on the
sampling system.
11. Prime the sample pump by:
a. From the Operating Menu press:
F4: System Prep > F7: Pump Prime.
b. Move the cursor to the Cycles field and type 3 for the number of
cycles to be performed.
c. Press F2: Sampler to begin priming the sample pump.
12. Check the sample tubing for leaks while the system is priming.
13. Perform a System Check and daily QC.
14. Record completion of this procedure in the Instrument Log.
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# Description
1 Left Port
2 To Sample Probe
3 100 µL Syringe
4. Remove the plastic fitting from the end of this tubing. Keep it to place on
the new sample tubing later in this procedure.
5. Open the pump panel to access the tubing on the end of the clot detector
board.
6. Slide the plastic sleeve back and remove the tubing from the right and
left sides of the clot check metal fittings. Remove the plastic sleeves from
both pieces of tubing before removing the tubings from the conduit.
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7. Remove the sample tubing from the 100µL syringe and pull through the
conduit.
8. At the sample probe, gently pull on the sides of the sample cover and lift
it off the probe assembly.
Figure 7-140: Sample Cover Probe Assembly
9. Remove the sample tubing from the sample connection and pull the
tubing up through the instrument.
10. Press the black sheathed end of the new sample tubing onto the sample
probe connection. Remove the plastic sleeves from the end of the sample
tubing.
11. Route the other end of the sample tubing down through the corrugated
black plastic conduit until it comes out of the opening on the left side of
the clot check board.
12. Slide the plastic sleeve onto the end of the tubing and slide the tubing
onto the clot check board fitting.
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13. Attach the sample tubing and press the tubing onto the left port of the
100 µL syringe.
14. Remove the plastic sleeve from the end of the tubing and feed it through
the corrugated black plastic conduit until it comes out of the opening on
the right side of the clot check board
15. Slide the plastic sleeve on the end of the tubing.
16. Flare the sample tubing if needed. Flare the tubing by inserting the flare
tool from the Spare Parts kit into the end of the tubing that will be
slipped onto the fitting. Slide the tubing onto the clot check board fitting.
17. Close the instrument lids and press the Pause key to turn on the sampling
system.
18. Prime the sample pump by:
a. From the Operating Menu press:
F4: System Prep > F7: Pump Prime.
b. Move the cursor to the Cycles field and type 3 for the number of
cycles to be performed.
c. Press F2: Sampler to begin priming the sample pump.
19. Check the sample tubing for leaks while the system is priming.
20. Perform a system check and daily QC.
21. Record completion of this procedure in the Instrument Log.
Replacing Clot Check Transducer Board
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4. Slide the plastic sleeve from the end of each piece of tubing connected to
the board. Then slide each piece of tubing off of the metal fitting.
5. Unplug J1 from the P1 connector from the left side of the clot check
transducer board.
6. Unscrew the white fittings from the clear manifold on the clot check
board to access the captive screws.
7. Using a small flat head screwdriver, unscrew both captive screws located
on the underside of the bracket that mounts the board. Remove the
board from the bracket.
8. Install the new board. Orient the P1 connection to the left and mount the
board using the 2 captive screws.
9. Plug the J1 connector into the P1 connection on the left side of the
board.
10. Reinstall the sample tubing onto the board. Slide the tubing on the "To
Sample Arm" side on the left fitting, and slide the tubing on the "To
Pump" side on the right fitting.
11. Push the instrument main power switch into its up position.
12. At the console menu, select option 1 or press Alt/1 to start the system.
13. Prime the sample pump by:
a. From the Operating Menu press:
F4: System Prep > F7: Pump Prime.
b. Move the cursor to the Cycles field and type 3 for the number of
cycles to be performed.
c. Press F2: Sampler to begin priming the sample pump.
14. Inspect the clot check transducer board and sample tubing for leaks as
the system is priming.
15. Perform a system check and daily QC.
16. Record completion of this procedure in the Instrument Log.
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5. Using the 5/64 Allen wrench, remove the screw that holds the sensor to
the bracket.
6. Install the new sample wheel home sensor onto the bracket.
7. Install the sample wheel home sensor and bracket in the instrument.
8. Restore power to the instrument following “Restoring Power After a
Controlled Shutdown” on page 8 of Chapter 2: Safety and Specifications.
9. Perform the Barcode Scanner Alignment, see “Barcode Scanner
Alignment” on page 4 of Chapter 8: Alignments.
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WARNING: Wait about five minutes after turning off the instrument
power for the source lamp assembly to cool before continuing
this procedure.
2. Lower the cuvette thermal chamber, see “Lowering and Raising the
Thermal Chamber” on page 24 of this chapter.
3. Loosen the two captive thumbscrews that hold the source lamp assembly
in place.
Figure 7-145: Source Lamp Assembly
# Description
1 P/J 72B
2 Screws
4. Unplug the source lamp connector P/J 72 B located inside the cuvette
thermal chamber. Remove the source lamp assembly.
5. Install the new source lamp assembly by reversing Step 2 through Step 4.
Ensure the holes at the corners of the assembly align over the pins before
tightening the thumbscrews.
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5. Unlock the U-seal solenoid assembly by pulling its curved locking bar to
the right. Move this assembly to the left away from the cuvette ring.
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# Description
3 U-Seal Solenoid
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# Description
1 Tie Wrap
2 Tie Mount
3 P/J 13 L
7. The cable is looped around the tie wrap. With needlenose pliers, break
the tie wrap and remove it.
8. Using the screwdriver gently pry the U-Seal element off its metal frame.
Figure 7-149: U-Seal Element Connector
# Description
1 U-Seal Element
2 Pry Here
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# Description
1 Tie Wrap
2 Tie Mount
3 P/J 13 L
12. Pass the P/J 13L cable through the tie wrap loop and wrap it around once.
Connect P/J13L. Tighten the tie wrap around the cable enough to hold
but not pinch it. Cut off the excess tie wrap.
13. Reposition the U-seal solenoid near the cuvette ring and push the curved
locking bar into place.
14. Position the alignment bar and tighten its thumbscrew.
15. Lower the barcode reader.
16. Close the instrument lids.
17. Record completion of this procedure in the Instrument Log.
Replacing the Vacuum Pump Muffler Filter
1. With the instrument in Standby, open the instrument doors. Open the
pump assembly by pressing its release button.
2. Remove the chemistry wash and water bottle from the instrument to
access the vacuum pump muffler.
3. Unscrew the black plastic cover from the vacuum pump muffler by
turning it toward the rear of the instrument.
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# Description
1 Cover
2 Filter
4. Remove the old felt filter off of the vacuum pump fitting and replace it.
5. Record completion of this procedure in the Instrument Log.
Replacing the Water Bottle
1. With the system in Standby, open the instrument doors. Open the pump
panel assembly by pressing its release button.
2. Remove the water bottle from the instrument.
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3. Disconnect connector P/J 1A. Follow the cable that comes out of the hole
labeled LEVEL to locate P/J 1A.
Note: Disconnecting P/J 1A prevents the automatic water supply
valve on the instrument from opening when the dip tube
assembly is removed from the water bottle.
Figure 7-153: Water Bottle
4. Loosen the collar ring on the cap of the water bottle (the collar ring turns
without moving the cap). Remove the dip tube assembly and place it in
the spare water bottle.
5. Reconnect P/J 1A. Place the water bottle back in the instrument. The
water bottle should begin filling with water.
6. Wait until the water bottle is filled, and prime all system pumps:
a. From the Operating Menu press
F4: System Prep > F7: Pump Prime.
b. Move the cursor to the Cycles field and type 3 for the number of
cycles to be performed.
c. Press Enter.
d. Press F1: All to begin priming.
7. Document this replacement on the Instrument Log sheet.
8. Clean the used water bottle. See “Cleaning the Water Bottle” on page 39
of this chapter.
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3. Using a screwdriver, loosen the two captive screws (one at the very top
and one at the very bottom of the board faceplate).
Figure 7-154: Card Cage
# Description
1 Captive Screws
2 Square Handles
4. Use the square handles on the board faceplate to pull the board halfway
out of its slot and then firmly reseat it. The board will click when it seats
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completely into its connector. The faceplate of the board will be flush
with all other boards.
5. Tighten the two captive screws.
6. Restore power to the instrument following “Restoring Power After a
Controlled Shutdown” on page 8 of Chapter 2: Safety and Specifications.
Running a System Check Using ABS
Complete this procedure using the following tools and supplies:
• ABS reagent cartridge in the instrument
• Fresh ABS solution from the same lot of ABS as the ABS reagent cartridge
that is in the instrument
• Sample cup
• Transfer pipette
• Segment
1. With the instrument in Standby, display the System Check Load List
screen by pressing: F4: System Prep > F4: System Check.
2. Fill a sample cup with fresh ABS solution.
3. Using the System Check Load List screen, enter a segment position for
this sample cup and then place the cup in that position.
4. Close all instrument lids.
5. Press F1: Start.
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6. Acceptable ranges for the system check results are listed below. If the
System Check printout indicates that any of your results are not
acceptable, see “System Check Troubleshooting” on page 9 of Chapter 9:
Troubleshooting.
Note: To delete this System Check, press the Alt/S key combination
to go to the Segment Status screen.
Press F1: On Board > F4: Delete Sample and follow the
message prompts as they appear.
Note: If all System Check Means are failing, and ABS lots were
recently changed, the operator must enter the carton value
from the ABS carton end flap every time a new ABS lot is
used.
Table 7-1: System Check Specifications For ABS
Mean SD
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Maintenance Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Mean SD
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5.25 500 mL
6.00 438 mL
8.00 328 mL
10.00 263 mL
12.00 219 mL
15.00 175 mL
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c. Fill the bottles with deionized water and install the lid assemblies.
d. Agitate each bottle gently to rinse the bottom of the lids and the
float switch assemblies.
e. Cycle water through the system as described in step 3e through 3h.
f. Remove the bottles again as described in steps 5a and 5b. Discard
the contents.
g. Rinse the water bottle one more time with deionized water.
6. Reassemble the water and chemistry wash systems:
a. Install the water bottle and lid assembly on the instrument.
b. Change the Water In field from MANUAL to PLUMBED.
1) From Operating Menu, press F6: System Config.
2) Move the cursor down to “Water In”.
3) Enter a password.
4) Allow the system to fill the water bottle.
5) Press Enter to change from manual to plumbed.”
6) Install a new Chemistry Wash bottle and update the count.
7) Perform another system prime as described in steps 3e
through 3h. Set each prime cycle back to the original number.
7. From the System Counters screen, select the Clean Probe routine.
Condition the photometric sample probe by using a normal serum
sample instead of bleach for the fluid.
8. Perform Daily QC.
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Chapter 8: Alignments
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Alignments Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Alignment Offsets
Each component is set during manufacture to a specific position. To
compensate for slight manufacturing variations, your system’s components
are corrected to manufacturing specifications using “offset” values determined
when you align the component. This offset value can be positive, negative, or
zero.
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Alignments Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Alignments
F5: Bar Code Align to rerun the alignment. Compare the new
alignment values with the alignment limits noted in Step a
and Step b above.
2) If both alignments pass, skip to Step 7. If either alignment
fails, continue with Step e through Step g.
e. Loosen the two screws that attach the inner barcode scanner
bracket to the baseplate and rotate the scanner bracket fully
clockwise.
f. Retighten the screws and then press F5: Barcode Align to rerun the
alignment
Figure 8-2: Barcode Scanner Screws
g. compare the new alignment values with the alignment limits noted
in Step a and Step b above.
1) If both alignments pass, continue with Step 7. If both
alignments fail, contact the Technical Solutions Center: Inside
U.S.: 1-800-441-9250; Outside U.S. Refer to the local support
team.
7. Press Exit and follow the messages to remove the barcode labeled
sample tubes in segment #1, position #5 and position #6.
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Alignments Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
# Description
1 Cuvette Ring
2 Plunger
3 Cuvette Diaphragm
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8. Verify the alignment by pressing F1: Start and visually inspecting the
position of the cuvette ring. Repeat Step 7 if necessary. When the cuvette
ring is aligned, press Exit.
9. Close the reagent lid.
10. Perform the “Photometer Alignment ” on page 19 of this chapter.
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Alignments Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
HM Module Alignments
This procedure includes alignments of parts on the HM module. To completely
align the HM module, perform the following two alignments as well:
• Sample arm to incubate wheel
• R2 reagent arm to incubate wheel
Those two procedures align other parts of the Dimension® EXL ™ system to the
HM module. See their alignment procedures later in this chapter.
The HM module component alignments consist of the following:
• Incubate and Wash Wheel Alignments:
1. incubate wheel to transfer opening
2. wash wheel to incubate wheel
3. wash probes to wash wheel, and
• Vessel Transfer Shuttle Alignments:
1. vessel transfer shuttle to incubate wheel
2. vessel transfer shuttle to wash wheel
3. vessel transfer shuttle to load
The three incubate and wash wheel alignments must be performed in the
order that they are listed on the screen.
All six alignments listed above must be checked/performed to align the HM
module components. Use message prompts as they appear to help you with
each alignment.
1. With the instrument in Standby, raise the IMT lid. Insert a long slender
tool into the reagent lid latch. Press firmly and raise the lid.
2. See “Removing the HM Incubation Wheel Cover” on page 3 of Chapter 7:
Maintenance.
3. Display the HM Module Alignments screen by pressing:
F7: Diagnostics > F3: Alignments > F6: HM Module.
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press F7: Check Align, then F8: Accept. Continue to “Aligning the Wash
Wheel to the Incubate Wheel” on page 9 of this chapter.
Note: After visually performing an alignment, press
F7: Check Align and ensure that the component moves and
returns to the new alignment position.
Incubate Wheel to The edges of the transfer station and the incubate wheel slots are
Transfer Opening aligned with each other so that there is an unobstructed path into
the incubate wheel.
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Alignments Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Wash Wheel The white alignment mark on the wash wheel is aligned to the white
to Incubate Wheel alignment mark on the incubate wheel.
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screws that secure the wash probe holder to the wash probe
platform.
3) Move the top of the wash probe until its tip is within the
white alignment marks.
4) While keeping the tip from moving, tighten the two screws.
5) Press F7: Check Align and check the wash probe tip
alignment to the white dot.
Wash Probes The wash probe tips are centered over and above the white
to Wash Wheel alignment dots on the wash wheel.
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Vessel Transfer Shuttle The edges of the vessel guide on the end of the vessel transfer
to Incubate Wheel shuttle are centered around the top of the vessel in the incubate
wheel.
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Vessel Transfer Shuttle The left edge of the shuttle vessel guide on the end of the vessel
to Wash Wheel transfer shuttle is just touching the vessel in the wash wheel.
4. When this alignment is complete press F8: Accept and continue with
“Aligning the Vessel Transfer Shuttle to Load” on page 14 of this chapter.
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Alignments Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
# Description
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Alignments
Vessel Transfer Shuttle The vessel guide on the end of the vessel transfer shuttle is
to Load centered over the top of the vessel in the transfer station.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Alignments
Note: The HM wheel and the LOCI® arm will move through the
auto-align process. When complete, the instrument gives the
opportunity to manually adjust the alignment. In most
instances the alignment will not need to be manually
adjusted. Only during troubleshooting should this be used. To
manually adjust, use the function keys to move the
corresponding component.
5. Press F8:Accept when complete. If finished, exit to the main operating
screen and remember to remove the LOCI® alignment gauge.
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Alignments Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Note: The HM wheel and the LOCI® arm will move through the
auto-align process. When complete, the instrument gives the
opportunity to manually adjust the alignment. In most
instances the alignment will not need to be manually
adjusted. Only during troubleshooting should this be used. To
manually adjust, use the function keys to move the
corresponding component.
5. Press F8: Accept when complete. If finished, exit to the main operating
screen and remember to remove the LOCI® alignment gauge.
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Photometer Alignment
1. Ensure that all instrument doors and lids are closed.
2. Display the Photometer Alignment and Calibration screen by pressing:
F7: Diagnostics > F3: Alignments > F4: Photometer.
3. Press F3: Arm Align.
4. Press F1: Start. Do not touch any other keyboard keys until this
alignment has been completed.
5. When the message “New alignment is: (old value: ) Do you want
to store? (y/n)” appears, the alignment is complete. The alignment is in
progress when the screen plot at the right slowly appears.
Figure 8-16: Photometer Alignment Screen
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3. Visually align the probe using the function keys described on the screen.
4. When the probe is aligned, press F8: Accept.
Note: After visually performing an alignment, press
F7: Check Align and ensure that the component moves and
returns to the new alignment position.
Note: Continue with “R1 Reagent Arm to Target (Cuvette)
Alignment” on page 22 of this chapter.
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Alignments Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
4. If the probe is aligned correctly, the probe should be within the flat
circled tip in the center of the alignment gauge and above the gauge. If
an adjustment is needed, continue with Step 5; if the probe is aligned
correctly, skip to Step 6.
Note: You should be able to fit a piece of printer paper between the
probe tip and the gauge and be able to feel resistance
without ripping the paper.
5. Visually align the probe using the function keys described on the screen.
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Alignments Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
5. Visually align the probe using the function keys described on the screen.
6. When the probe is aligned, press F8: Accept..
7. Press Exit and follow the messages as they appear to remove the reagent
tray alignment gauge and return the reagent cartridge (if one was
removed) to its original slot in the reagent tray.
WARNING: If you removed a reagent cartridge, you must place the same
cartridge in the reagent tray slot from which you removed it.
8. Close the instrument lids.
Note: After visually performing an alignment, press
F7: Check Align and ensure that the component moves and
returns to the new alignment position.
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# Description
2. Use the 9/64 Allen wrench to turn the adjustment screw on the bracket in
the same direction (clockwise or counterclockwise) that the reagent
probe needs to be moved. One turn of the adjustment screw will move
the home flag which translates to the probe approximately one
millimeter.
3. Press F7: Check Align after each time the adjustment screw is turned.
When any part of the probe tip or securing nut is above the hole in the
cover of the drain, tighten the two alignment bracket screws.
4. Return to Step 3 of the “R2 Reagent Arm to Drain Alignment” procedure.
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Note: You should be able to fit a piece of printer paper between the
probe tip and the gauge and be able to feel resistance
without ripping the paper.
4. If the probe is aligned correctly, the probe should be within the flat
circled tip in the center of the alignment gauge and above the gauge.
5. If an adjustment is needed, continue with Step 6; if the probe is aligned
correctly, skip to Step 7.
6. Visually align the probe using the function keys described on the screen.
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the screen and repeat steps 4-6 above as you align the probe to two
more targets.
Note: Continue with “R2 Reagent Arm to Reagent Tray Alignment” .
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Alignments Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
WARNING: If you removed a reagent cartridge, you must place that same
cartridge in the reagent tray slot from which you removed it.
7. Replace the HM incubation wheel cover.
8. Close the instrument lids.
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Alignments Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
5. Use the right arrow key to move the cursor box to the Auto Loader mode.
6. Press F5: Insert Gauge and follow the messages as they appear on the
screen to insert the reagent tray alignment gauge into the instrument.
If you are prompted to remove a reagent cartridge, this same cartridge
must be placed into the instrument at the end of this procedure.
7. The alignment positions are described and shown Table 8-1.
Table 8-1: Alignment Positions
Auto Loader Press F6: Calib Loader. There is no alignment position to check. When
the automatic Flex® loader stops all movement, the alignment is
complete.
R1 Arm Press F1: Pos Gauge. The R1 probe should be above and centered within
the target circle on the gauge. Use the function keys described on the
screen to align to the alignment position.See Figure 8-24 on page 25 of
this chapter.
R2 Arm Press F1: Pos Gauge. The R2 probe should be above and centered within
the target circle on the gauge. Use the function keys described on the
screen to align to the alignment position. See Figure 8-27 on page 29 of
this chapter.
Note: You should be able to fit a piece of printer paper between the
probe tip and the gauge and be able to feel resistance
without ripping the paper.
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WARNING: If you removed a reagent cartridge, you must place that same
cartridge in the reagent tray slot from which it was removed.
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Alignments Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
# Description
1 Alignment Gauge
2 Adapter
2. Press F7: Check Align and follow the messages as they appear on the
screen to place the cup alignment gauge in the top of an adapter in
segment #1, position #1 (marked inside the sample area).
3. If the probe is aligned correctly, it should be positioned above the gauge
and within the target circle of the gauge.
Note: You should be able to fit a piece of printer paper between the
probe tip and the gauge and be able to feel resistance
without ripping the paper.
4. If an adjustment is needed, continue with Step 5; if the probe is aligned
correctly, skip to Step 6.
5. Visually align the probe using the function keys described on the screen.
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8. Press F7: Check Align and follow the messages on the screen to move
the cup alignment gauge into the top of an adapter in segment #1,
position #2.
9. If the probe is aligned correctly, it should be positioned just above the
gauge, within the target circle.
10. If an adjustment is needed, continue with step 9. If the probe is aligned
correctly, skip to step 10.
11. Visually align the probe using the function keys described on the screen.
12. When the probe is aligned, press F8: Accept.
13. Press Exit and follow the messages on the screen to remove the cup
alignment gauge.
Note: Continue with “Sample Probe to Drain Alignment” .
2. If the probe is aligned correctly, the probe should be centered above the
drain hole. If your instrument drain has two holes in it, align to the hole
that is closest to the reagent tray. If an adjustment is needed, continue
with Step 3. If the probe is aligned correctly, skip to Step 4.
3. Visually align the probe using the F1 and F2 function keys.
Note: Press F3: Probe Down for an improved view of the probe
position and to see if it is centered above the drain hole.
Note: After visually performing an alignment, press
F7: Check Align and ensure that the component moves and
returns to the new alignment position.
4. When the probe is aligned, press F8: Accept.
Note: Continue with “Sample Probe to the HM Incubate Wheel
Alignment” on page 38.
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Alignments Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Note: You should be able to fit a piece of printer paper between the
probe tip and the gauge and be able to feel resistance
without ripping the paper.
4. Visually align the probe using the function keys on the screen.
a. F1 and F2 move the sample probe clockwise and counterclockwise.
b. F3 and F4 move the sample probe up and down.
c. F5 and F6 move the incubate wheel clockwise and
counterclockwise.
5. When the probe is aligned, press F8: Accept.
6. Replace the HM incubation wheel cover
Note: Continue with “Sample Probe to the IMT Port Alignment” on
page 39
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4. Visually align the probe using the function keys on the screen.
a. F1 and F2 move the sample probe clockwise and counterclockwise.
b. F3 and F4 move the sample probe up and down.
5. After aligning, press F7: Check Align.
6. When the probe is aligned, press F8: Accept.
Note: Continue with “Sample Probe to the IMT Port Alignment” on
page 39.
Note: Sample Probe max depth alignment is required for initial
sample probe alignment, but is not routinely performed.
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Alignments Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
2. Move the box in the Max Depth in: field to the appropriate sample
container.
3. Press F7: Check Probe and follow messages as they appear to place the
appropriate container into the proper segment position. Any tube/sample
removed from segment #1 (marked inside the sample area) to insert the
container for alignment, will be placed back in its position later in this
procedure.
4. Set the correct probe depth using the F3 and F4 function keys. After
aligning, press F7: Check Align and ensure that the system moves and
returns to the new alignment position.
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Primary Tube Align to the primary tube that sits the highest in the segment. The bottom
edge of the nut on the sample probe should be even with the top of the
primary tube.
PED Align to the pediatric (PED) tube that sits highest in the segment. The sample
probe tip should be above the bottom of the pediatric (PED) tube.
SSC Align to the primary tube/SSC combination that sits the highest in the
segments. The sample probe tip should be above the bottom of the SSC. The
size of the sample tube used during this SSC alignment should now be used
with all SSC samples.
• For processing whole blood samples, always place the SSC in the same
size tube used for the SSC sample probe maximum depth alignment.
Refer to the method IFU for sample handling details.
• For processing serum and plasma, primary tube/SSC combinations that
present the SSC at a lower height may be used only if the SSC is filled with
a maximum of 1.0 mL of sample.
Note: You should be able to fit a piece of printer paper between the
probe tip and the gauge and be able to feel resistance
without ripping the paper.
Note: Before using a new tube size or type, all maximum depth
alignments should be checked.
Figure 8-39: Primary Tube
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Alignments Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
# Description
2 Probe
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Chapter 9: Troubleshooting
2011/09 9-1
Troubleshooting Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Troubleshooting Overview
This Troubleshooting chapter describes information to help you resolve
problems on the Dimension® EXL™ integrated chemistry system. The two main
components to troubleshooting are:
• Specifying the problem by obtaining all information related to it.
• Solving the problem.
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Help Keys
The Help keys provide information on:
• A specific screen
• What tasks can be performed on a screen
• What the function keys on that screen do
• A brief procedure for how to perform the tasks or a cross-reference to a
procedure in this Operator's Guide
Table 9-1 shows how to access Help screens.
Table 9-1: Help Screens
Alt/M Pressing the Alt and M keys simultaneously displays active error messages. It
does not display error messages that have been viewed and reset.
Help (from the Displays the screens where help for performing a task is available. The Quick
Operating Menu) Index includes the function key sequence to display the screens from the
Operating Menu.
Help (from any Displays information on how to use the screen and its function keys.
other screen)
Shift/Help If the cursor is in a field where you can enter data, pressing this key
combination displays acceptable entries for the field.
Alt/Help Displays a screen that explains how Help works and a list of the Alt key
combinations. Includes much of the same information that is provided in this
table.
Control/Help Creates a list of information for all operating condition icons. Scroll down on
this page to get information on a particular icon.
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Troubleshooting
Remote Access
The Technical Solutions Center (TSC) may ask permission to remotely access an
instrument using the instrument modem. There are two modes of access:
monitor and control. In monitor mode, the TSC specialist can look at files in the
instrument’s computer memory and/or see your screens. In control mode, the
TSC specialist can perform the same keyboard functions as the operator
standing at the instrument. The TSC specialist will give you specific directions
over the telephone to establish the remote link between your instrument and
the TSC.
Remote Control
WARNING: When taking control of an instrument, ensure that instrument
operators are aware that remote access may move
instrument components thereby presenting a hazard to the
operator.
Remote control is used with various types of VNC servers and/or KVM/IP
devices. When an instrument is engaged in a remote control session where
VNC software is resident on an instrument, a notification will be displayed:
“Exercise caution while performing activities involving the physical movement
of instrument modules. Please ensure that users stay clear of the instrument.”
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Troubleshooting Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Chemistry Troubleshooting
Instrument problems are evident when the system displays an error message.
Chemistry problems, however, may not display an error message and may
become evident only when test results are reviewed.
See “Understanding Test Report Messages” on page 14 of Chapter 11:
Appendix for details on how to interpret the messages accompanying test
results.
The following tips help prevent chemistry problems:
• Perform scheduled maintenance.
• Calibrate or verify a new lot of Flex® reagent cartridges before you run out
of the current lot.
• Check the expiration date of the calibrator/verifier in use.
• Use fresh quality control materials and check their expiration dates.
• Be sure that QC values are within the assay range identified for each
method.
• Check for interfering substances that may affect test results (see the
method IFU).
• Assure proper handling and preparation of samples (pretreatment,
preservative, etc.).
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Troubleshooting Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
4. Check the short sample load list for a possible short sample in the cup
that contains the ABS solution.
Stray light entering The reagent lid must be closed and all instrument side panels and
doors must be closed when a system check is processing.
Source lamp was installed This will be the cause only if you have just installed a new source
incorrectly lamp. Remove and reinstall the source lamp. See “Replacing the
Source Lamp” on page 136 of Chapter 7: Maintenance.
Optical filter is dirty or has Remove the specific optical filter that is failing, inspect it, and either
become delaminated clean or replace it. See “Replacing/Cleaning Optical Filters” on
page 87 of Chapter 7: Maintenance.
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Using a new lot of ABS/CHK and Display the Daily Maintenance screen and enter the value from
failing to enter ABS/CHK carton the ABS/CHK carton flap into the Carton Value field for the
flap value into the software ABS/CHK lot
Loose tubing on the reagent Check the tightness of all tubing connections on the R1 or R2
syringes. reagent pump panel.
Reagent probe is misaligned. Realign the reagent probe.See “R1 Reagent Probe Alignments”
on page 20 of Chapter 8: Alignments and See “R2 Reagent Probe
Alignments” on page 25 of Chapter 8: Alignments.
Crimped or pinched reagent Check if the reagent tubing is crimped (bent) or pinched.
tubing Replace any tubing that appears to be damaged.
Reagent probe tip is not Replace the probe tip. See “Replacing a Reagent Probe Tip” on
functioning properly. page 110 of Chapter 7: Maintenance.
Reagent syringe plunger tips Replace both the 500-µL and the 2500-µL reagent syringes on
are not functioning properly. the reagent pump panel for the appropriate pump. See
“Replacing a Pump Syringe” on page 101 of Chapter 7:
Maintenance.
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Not filling the sample cup with Look at the System Check printout and see what ABS/CHK Flex®
ABS from the same lot that the lot number was used for the System Check by the instrument.
instrument used for the System Ensure that you filled the sample cup with ABS from this same
Check. lot number.
Using an old ABS sample ABS sample older than one hour should be discarded and
replaced with a fresh ABS sample.
Using a new lot of ABS/CHK and Display the Daily Maintenance screen and enter the value from
failing to enter ABS/CHK carton the ABS/CHK carton flap into the Carton Value field for the
flap value into the software. ABS/CHK lot.
Loose tubing on the syringe. Check the tightness of all tubing connections on the sampler
pump panel.
Plugged sample probe or dirty Clean the sample probe and drain. See “Cleaning the Sample
sample drain Probe and Drain” on page 38 of Chapter 7: Maintenance.
Sample probe is misaligned. Realign the sample probe. See “Sample Probe Alignments” on
page 34 of Chapter 8: Alignments.
Loss of water to the sample This can be caused by crimped or pinched tubing, loose or
drain. disconnected water tubing, or a broken fitting on the bottom of
the sample drain. Replace any tubing that appears to be
damaged. Tighten (or replace) any loose sample water tubing. If
the sample drain fitting is broken, contact the Technical
Solutions Center: Inside U.S.:
1-800-441-9250; Outside U.S. Refer to the local support team.
Sample syringe plunger tips are Replace both the 100-µL and the 2500-µL sample syringes on
not functioning properly. the sample pump panel. See “Replacing a Pump Syringe” on
page 101 of Chapter 7: Maintenance.
Rerun the system check. If the system check continues to fail, follow the
troubleshooting items listed in this section as appropriate and then rerun the
system check.
The acceptable mean and SD for the HM wash system are:
Mean = 10% of the assay value listed on the end flap of the ABS/CHK carton
±4 mAU, SD 1.6
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High Mean for Wash Chemistry Wash Tubing Pinched Ensure that the tubing is not
Probe 1 or 2 pinched or cut.
High Mean for Wash Wash Probe Tubing Ensure that the wash probe
Probe 1 and 2 Disconnected tubing is connected to the
proper vacuum sensor.
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Error Messages
The Dimension® EXL™ integrated chemistry system has an area near the top of
the screen that is used only to show error messages. In addition, the system
software has two screens, Active System Errors and Error Log, that enable you
to review errors that have occurred.
When the system detects an error condition, it displays an error message in the
error message area, and the alarm sounds.
The system can display only one error message at a time. If more than one
error condition occurs at the same time, the system uses a priority ranking to
determine which one to display.
Some error messages will stop system processing; others will not. If system
processing stops, reset the instrument by pressing the Reset key to clear the
error message and resume processing.
An error message may have one or more minor error messages associated with
it. These minor error messages provide more specific information about why
the error occurred and are helpful with troubleshooting.
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The error log contains the last 50 major error messages. To print this log, press
F4: Print Log.
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IMT Troubleshooting
IMT Results Troubleshooting
If the IMT results are questionable and there is no error message indicated by
the instrument or test report slip, for example, any of the following issues may
have occurred:
• QC is out
• Failed delta check on the LIS
• Results are inconsistent for the patient‘s clinical picture
• Abnormal Anion gap
Follow the steps in this section to troubleshoot these situations.
1. Check for insufficient sample in the sample container.
2. Rerun the sample. If the results are still questionable, do the basic
troubleshooting steps below for Na, K, Cl results.
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Overview
The procedures in this chapter describe how to configure systems and reports
of the Dimension® EXL ™ system to meet the specific requirements of your
laboratory. Typically, these configurations are set at the time of installation
and may not need to be changed again. However, you may want to set up
configurations and do other customizing to meet day-to-day changes in
workload and laboratory operation.
Siemens Healthcare Diagnostics provides validated instructions for using
certain Emit® assays. Contact the Technical Solutions Center for a copy of the
application sheets.
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Field Meaning
Enter Sample Data Indicates which type of Enter Sample Data screen, NORMAL (single samples) or
Mode BATCH (batch samples), appears for entering patient sample information.
*RMS Option ON indicates that RMS module is used. OFF indicates that RMS module is not
Configured used. If RMS power is OFF, the words Automatic Cartridge Removal (see below)
appear as the field name.
*Automatic Rerun ON indicates that the instrument will rerun a test if there were instrument
errors during the initial test processing that were resolved by the instrument.
The test will be rescheduled without any operator intervention.
This field must be set to ON to use the Automatic Dilution, Automatic Repeat
for Panics and Automatic Reflex Testing.
*Automatic Dilution ON indicates that the system will rerun the test using a smaller sample volume
when autodilution conditions are met.
*Waste Out PLUMBED indicates that system chemistry wastes are automatically pumped to
an external waste collection system. MANUAL indicates that these wastes are
collected in the instrument waste bottle and must be emptied by the operator.
*Automatic Repeat ON indicates that an automatic rerun of a test will be run if the test result is
for Panics outside the panic values entered by the operator for that method. See
”Automatic Panic Rerun” in this chapter.
*Automatic Reflex ON indicates that an automatic reflex test will be run if the test result is outside
Testing the reflex limits entered by the operator for that method. See “Automatic
Reflex Testing” on page 12 of this chapter.
*HM Module
Configured YES indicates that the HM module is available for use. Both HM fields must be
set to ON.
*Automatic HM
YES indicates that reaction vessels will be loaded automatically by the system
Vessel Load to the reaction wheel. Both HM fields must be set to ON.
LOCI® Module ON indicates that the LOCI® module is available for use.
Configured
Clot Check ON activates clot check for samples and enables the software to take actions if
Configured a clot is detected.
OFF indicates that the instrument will not perform clot check when aspirating
samples. Only the hardware monitoring will be active. The clot check icon will
turn yellow.
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F1: Method Param Enter/view method-specific information for each method you run on
Dimension® EXL ™ system. See “Entering Method Parameters” on page 45 of
this chapter.
F2: Define Panels Create ten panels with up to 20 tests on each panel. All 20 tests can then be
requested with a single keystroke. See “Creating Panel Keys” on page 70 of this
chapter.
F3: Date/Time Change the date and time. To change the date and time:
1. Press F3: Date/Time.
2. In the Date field, type the day. Press F2: Next Month to select the month.
Then type the year.
3. Move the cursor to the Hour and Minute fields and enter the time. Use the
24-hour time convention for the hour.
4. If you want to display the date/time as MM-DD-YY rather than DD-MM-YY
as in Step 2 above, press the Enter key. Verify that the entered date and
time are correct.
5. Press F1: Store Change before exiting from this screen.
F4: Computer Set up the Dimension® EXL ™ system for your laboratory computer operations.
See “Entering Sample ID Information” on page 88 of this chapter.
To establish communications with an LIS:
1. Press F4: Computer, then press F4: Communications.
2. Move the cursor to each field on the screen and use the Enter key to
change its setting to the appropriate information for your laboratory.
3. Press F2: Store Changes to store changes before leaving this screen.
F5: IMT On / Off Configure the IMT system. Press this function key and the IMT status box at the
top of the screen will change appropriately. “IMT Not Config” in the box
indicates that the IMT is OFF. Any other wording in this box indicates that the
IMT is configured.
F6: Select Printer Configure the printer, creating the header and setting paper specifications for
printed test reports, and if applicable, creating a custom format for an external
printer. See “Configuring the Printer” on page 79 and “Customizing an External
Printer Report” on page 80 of this chapter.
F7: Password Change the system password. To do this, press this function key and follow the
messages as they appear on the screen.
F8: More Options Displays the System Configuration Secondary Menu screen.
1. Press F1: Clot Config.
2. Press F8: Temperature
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Conifguration Description
Field Meaning
Translate Clot OFF is the default selection and allows Clot Check Err to be transmitted
Check LIS Error through the LIS.
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3. Move the cursor box to the Reflex fields and enter the less than (<) and
greater than (>) limits that will trigger the reflex test. You can enter any
limits, even those that are within the “normal” results for the method.
You can have one-sided limits by entering only one of these fields.
4. With the cursor box now positioned to the right of the Run field, press
the test key for the method you want to reflex automatically when the
test result is outside the reflex limits you entered in the previous step.
Only one reflex test is permitted per method.
Low and high limits The result is outside this range, either above or below it.
WARNING: As with any sample run on the Dimension® EXL ™ system, you
must ensure that there is enough sample in the sample
container to run not only the requested tests but also any
subsequent reflex tests that may be automatically run.
6. To set up a reflex test for another method, press any arrow key to move
the cursor out of the Run field, then press the test key for the next
method.
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Low and high limits The result is outside this range, either above or below it.
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Note: A result with a high panic value on the test report slip has the
letters ”hp“ after it (or ”lp“ for a low panic value). Since two
results are shown because of the automatic panic rerun,
mean, SD, and CV for these results also appear on the test
report. All results are sent to the host computer.
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Why was
Test test run? Test Result
1 - CA Original test 13.1 exceeds both the panic and reflex limits for CA.
2 - CA Hp rerun This test was run because the 1 - CA result exceeded the
from 1-CA panic limits for CA.
3 - PHOS Reflex test This test was run because the 1 - CA exceeded the reflex
from 1-CA limits for CA.
This test was run because the 3-PHOS 1.2 result exceeds
reflex limits for PHOS. No additional reflex testing will be
4 - MG Reflex test done for 4-MG because in this example the MG method did
from 3-PHOS not have a reflex test specified.
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5. Press F8: Store. Only those calculated results that are turned on will have
their changes stored.
Note: If the calculated result always appears with a Hi or Lo error
message, check the Interval field entry for that result. If a
calculated result is turned on but no interval is entered, all
reporting of that calculated result will contain a Hi or Lo error
because the system will use 0.0 - 0.0 as the interval.
Table 10-1: Calculated Results Equations and k Values
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k2 = 0.056
k2 converts GLUC/GLU results reported in mg/dL to millimolar
OSMO Calculated
Osmolality concentration. If GLUC/GLU is reported in mmol/L, then k2 = 1.0
k3 = 0.36
k3 converts BUN results reported in mg/dL to millimolar
concentration. If BUN is reported in mmol/L, then k3 =1.0
9
The number 9 is a constant to account for all other osmotically
active solutes present in the solution.
The OSMO calculated result uses either the GLUC or GLU result in
the equation, whichever was run on the sample.
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An unused Reference Interval fluid field, such as CSF/Blood for the BUN
method, may contain the reference interval for a calculated result.
TP CSF/Blood GLOB
TU CSF/Blood FTI
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Calibration Configuration
Define Calibration Product
You can store 150 calibrator products on the instrument.
To display the Define Calibration Products screen, press the Calib Alert key on
the touchscreen, then press F5: Define Calibration Product. Display the
screen from the Operating Menu by pressing:
F5: Process Ctrl > F1: Calibration. Enter Password. Press F5: Def Cal Product.
To enter data on this screen, you can either scan the calibration product
barcode or enter data manually.
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2. Highlight the product you want to edit. Press F1: Edit Product to display
the Define Calibration Products screen.
3. Use the appropriate function keys to make changes.
Table 10-2: Function Keys
Key Function
F1: New Product Use to clear the screen and enter additional products.
F2: Delete Method Use to remove the highlighted method from the list.
F3: Chg Prod Name Use to enter a different name in the Cal Product field.
F4: Chg Prod Lot Use to enter a different lot number in the Cal Lot field.
F5: Chg Prod Exp Use to enter a different date in the Product Expiration field.
4. To add tests to the product, use the test keys, then enter the bottle
values in the appropriate Level fields. Use appropriate units when
entering values.
5. Press F7: Store.
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Parameter Meaning
Max Neg Bias Maximum allowable negative bias (residual) for each calibrated
level.
Max Pos Bias Maximum allowable positive bias (residual) for each calibrated
level.
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Key Function
F6: PRNT ALL PARMS Prints all parameters for all methods listed on the screen in
alphabetical order.
F7: PRNT SEL PARMS Prints parameters for the highlighted method.
F8: Print Act List Prints the list displayed on the screen.
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Correlations
Some situations may require that the Dimension® EXL ™ system and an
alternate system or method provide comparable results. It is suggested that
the alternate method be correlated to provide the same results as the
Dimension® EXL ™ system. If, however, you find it necessary to correlate your
Dimension® EXL ™ system to the alternate method, the Correlation feature
provides a way to adjust results by applying slope and intercept values derived
from a correlation between the two methods.
The correlation feature uses simple linear regression to calculate the
correlation curve y = mx + b where x is the expected result and y is the
observed result. When you store the correlation curve, the applied slope (mA)
and intercept (bA) are calculated as mA = 1/m and bA = -b/m. The applied slope
and intercept, stored in the Correlation Entry screen, are used to calculate a
correlated result using the following equation:
correlated result = (mA)(uncorrelated result) + bA
When the correlation is performed offline, the applied slope and intercept
values (as calculated above) are entered in the Correlation Entry screen.
Correlation is applied only to patient samples and QC. Correlation is not
applied to calibration; therefore, do not adjust calibrator bottle values when
you calibrate a correlated method.
Correlation Study
A split sample correlation study should be run using at least 20 patient samples
spread throughout the assay range of the method. Do not use quality control
material or calibrators as the sample. You will use the observed results from
the study to calculate slope and intercept values for the method.
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After storing the applied slope and intercept, be sure to establish new QC
ranges for the method.
Note: When correlating a method, the reference interval, panic
values, reflex values, and quality control ranges may change.
Field Enter
Sample Sample ID
Note: When entering data, only the same number of decimal places
as shown on the Method Parameters screen for a method are
permitted.
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4. After entering all the sample results, press F7: Show Correl'd. The screen
now shows the expected and correlated data (calculated using the
observed data and the regression statistics), and a linear regression plot
for the correlated data.
5. Review the information on this screen.
a. expected and correlated values should now be nearly identical.
b. statistics should be close to the following:
slope = 1.000
intercept = 0.000
r = 1.000
6. Decide if the information on this screen is acceptable for your laboratory
operations.
a. If the information is acceptable, skip to Step 7.
b. If the information is not acceptable, continue with Step 8.
Note: To delete all data (expected and observed (from the cursor to
the end of the list); place the cursor on the line where the first
data entry mistake occurs and press F4: Delete To End.
7. Look for possible discrepant result pairs. Delete discrepant result pairs as
you determine necessary. To delete a discrepant result pair:
a. Press F7: Show Observed
b. Move the cursor to the result pair line.
c. Press F3: Delete Line.
d. Press F7: Show Correl’d.
e. Return to Step 5.
8. Press F6: Correlated To and enter the name of the method or instrument
to which you are correlating the Dimension® EXL ™ system.
9. Press F7: Show Observed, then F8: Print to produce a report of the data
you entered. You will not be able to view this data after you store the
correlation.
10. Press F7: Show Correl'd. Press F8: Print to produce a report of the
correlated data.
11. Press F3: Accept Corr to store the information for the method.
12. Press Exit to view the Correlation Entry screen. The system-calculated
slope and intercept for the method will now appear on this list, along
with Date Correlated or Correlated Name.
If you press F5: Show Cor Date, the “Correlated To” column changes to
“Date Correlated”.
13. Confirm that the assay range from the Siemens method IFU is entered in
the Method Parameters screen.
14. Establish and enter new reference interval, panic values, and reflex limits
for the correlated method.
15. Establish new QC ranges for the correlated method. The slope and
intercept from the correlation will now be applied to all samples,
including QC, in order to maintain the “Correlated To” status.
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Removing a Correlation
If you no longer want to use the correlation data for a method, simply change
the slope and intercept values to 0 (zero):
1. Display the Correlation Entry screen.
2. Type your password and press Enter.
3. Move the cursor to the method, or press the test key for the method.
4. Enter 0 for the slope value. Press Enter.
5. Enter 0 for the intercept value. Press Enter.
6. Press F2: Store.
7. Confirm that the assay range from the Siemens method IFU is entered in
the Method Parameters screen.
8. Establish and enter new reference interval, panic values, and reflex limits
for the method.
9. Establish new QC ranges for the method.
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Correlation Date
The F5 function key on the Correlation Entry screen, toggles the display
between “Correlated To” and “Date Correlated”. Pressing F5: Show Cor Date,
shows the correlation date where applicable.
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Cursor Keys Move the cursor to the method you want to hydrate and then
enter the number of tests you want to hydrate.
Test Keys Press the test key for the method you want to hydrate and
then enter the number of tests you want to hydrate.
Panel Keys Press a predefined panel key, P1–P10, and then enter how
many times you want this panel to be hydrated.
Pre-programmed Setup Lists Press F1: Load Setup 1 or F2: Load Setup 2 for your
preprogrammed setup list.
3. Press Enter.
4. Repeat Step 1 through Step 3 until you have entered all your hydrations.
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ONLY Hydrations will be performed only on each day through the next
Friday. After that Friday, you need to return to the
Mon to Fri Inventory/Hydration screen and reactivate the hydration period.
ONLY Hydrations will be performed only on each day through the next
Sunday. After that Sunday, you need to return to the
Mon to Sun Inventory/Hydration screen and reactivate the hydration period.
WEEKLY Hydrations will be performed each day until you to change the
hydration period.
3. Move the cursor to the hour and minute fields. Enter the time for the
hydration to begin. Remember to use the 24-hr clock convention.
4. Move the cursor to the right. Use the Enter key to select WEEKLY or
ONLY. See the table above for how this field works with the Day field.
5. Move the cursor to the Activated field. Press the Enter key. The Activated
field changes to On and the Timer Countdown field indicates the time
remaining until hydration begins.
Note: If a Timed Hydration is scheduled, and F4: Hydrate Now is
pressed, the entire pre-programmed setup will begin to
hydrate.
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4. Select F1: Clot Config to access the Clot Check Configuration menu.
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4. Select F1: Clot Config to access the Clot Check Configuration menu.
Figure 10-13: Clot Check Configuration Menu
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1. With the instrument in Standby, press the Pause key to stop the
sampling system.
2. Insert a long slender tool to raise the reagent lid.
3. Open both instrument doors to remove the existing clot check tubing.
Remove the sample tubing from the left port of the 100 µL syringe.
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# Description
1 Left Port
2 To Sample Probe
3 100 µL Syringe
4. Remove the plastic sleeve from the end of the tubing. Set this fitting
aside for use later in the procedure.
5. Open the pump panel to access the tubing on the end of the clot check
board.
6. Slide the plastic sleeve back and remove the tubing from both sides of
the clot check fittings. Remove the plastic sleeves from both pieces of
tubing before removing the tubings from the conduit.
Figure 10-15: Clot Check Tubing
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7. Remove the sample tubing from the 100 µL syringe and pull through the
conduit.
8. At the sample probe, gently pull out on the sides of the sample cover and
lift it off the probe assembly.
Figure 10-16: Sample Probe Cover Assembly
9. Remove the sample tubing from the sample probe connection and pull
the tubing up through the conduit.
10. Using clot check bypass tubing, press the black sheathed end of the new
sample tubing onto the sample probe connection. Remove the plastic
sleeves from the end of the sample tubing.
11. Route the other end of the sample tubing down through the corrugated
black plastic conduit until it comes out of the opening on the left side of
the clot check board.
12. Route the tubing through the right side of the conduit all the way
through the 100 µL syringe.
Figure 10-17: Clot Check Conduit
13. Attach the sample tubing onto the left port of the 100 µL syringe.
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14. Close the instrument lids and press the Pause key to turn on the
sampling system.
15. Display the Pump Prime menu. Move the cursor to the Cycles field. Type
3 for the number of prime cycles to be performed. Press Enter. Press
F2: Sampler.
16. Check the sample tubing for leaks while the system is priming.
17. Perform a system check and daily QC.
18. Record completion of this procedure in the Instrument Log.
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IMT Configuration
You can customize two items related to IMT processing for your laboratory's
needs:
• Include ECO2 in Lytes test method key
• Specify the time interval for IMT bleach/condition soak
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Calibration Vol This field cannot be changed. It appears under the Standard Vol field
only for those methods (such as C3, C4, IGA, IGG, IGM) that must use
this volume for their calibrations.
Auto Dilute Vols Use the keyboard or keypad to enter values for both serum/plasma
and urine samples. Refer to the tables on the pages that follow for
the recommended autodilute AD sample volumes for each
autodilute method.
Intervals Use the keyboard or keypad to enter the upper and lower limits for
the reference, assay range, and panic intervals for a fluid.
• Reference Intervals:
May be adjusted according to laboratory normal
population.
• Assay Intervals:
Set by Siemens. Only use assay intervals published in
each method’s IFU.
• Panic Intervals:
Can be set using upper and lower limits or can be single
sided. Enter a lower limit to automatically rerun test
results that are lower than this limit. Enter a higher limit
to automatically rerun t est results that are higher than
this limit.
Reflex If < or > Use the keyboard or keypad to enter a less than and/or greater than
value which, if exceeded, will trigger the automatic reflex test
entered in the Run field.
Run Use the test keys to enter the method you want to be automatically
reflexed if the test result for this method is outside the reflex limits
entered in the Reflex If field. Only one method can be entered in this
Run field.
LOT ID and (C0 - C4) The lot ID and calibration coefficients (C0-C4) are entered
automatically in these fields by the software following the
calibration/verification of the lot. Some coefficients are constant for
certain methods. Refer to the method IFU for more information. The
instrument can hold a maximum of two lot numbers per method in
system memory.
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Automatic Dilutions
The instrument can perform two types of automatic dilutions:
• Automated Urine Dilutions (AUD) – for BUN, CREA, PHOS, and URCA
• Autodilute (AD) – user programmable for urine and serum/plasma samples
Autodilute (AD)
Once you enter the autodilute Method Parameters and configure the system to
autorerun and autodilute, the Dimension® EXL ™ system automatically
performs sample dilutions whenever the calculated result is above the assay
range, or the absorbance of the sample and reagent exceeds the upper
absorbance limit for the method. To perform the automatic dilution, the
system aspirates a reduced sample volume (similar to the way you would make
a manual dilution). The dilution ratios are based on incremental sample
volume adjustments.
The Dimension® EXL™ system does not perform dilutions based on the Dilution
field on the Enter Sample Data screen – this field is used for your convenience
when you want the instrument to calculate the results of your manual
dilutions. (If a number is entered in the Dilution field, the Dimension® system
will not autodilute the sample.) For HCG and LHCG and the above AUD only,
entering a number in the Dilution field will not disable automatic dilution.
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To configure the Dimension® EXL ™ system autodilute feature, you must first
activate both the autodilute and autorerun features on the System
Configuration screen.
1. If either the Automatic Rerun or Automatic Dilution fields is off, move the
cursor to the field and press Enter to change the setting to ON.
2. When both fields are on, press F1: Method Parameters. Type your
password and press Enter.
3. Press the test key of the first method to edit and highlight the first
autodilute volume field.
4. Enter the proper autodilute volume for each sample type. Press F4: Store
Param's or F5: Store & Print before exiting or choosing the next method.
Note: To use the Autodilute (AD) feature, the Autorerun and
Autodilute fields on the System Configuration Menu screen
must both be set to ON.
Note: If the instrument automatically dilutes a sample, the word
“Diluted” appears next to the method on the printout. If the
ample was diluted and the result is still above the assay
range for the method, the message “assy rng/dilu” will appear
next to the method. In this case a manual dilution should be
performed to determine the correct result.
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Standard Recommended
Dilution Other Qualified AD
Method Sample AD Sample
Factor Sample Volumes (µL)
Volume (µL) Volume (µL)
CA 5 2 2.5 3, 4
GLU 3 2 1.5 —
GLUC 3 2 1.5 —
MALB 17 2 8.5 —
UCFP 10 5 2.0 —
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AHDL 3 2 1.5 —
ALB 5 2 2.5 3, 4
ALC 3 2 1.5 —
ALDL 3 2 1.5 —
ALP 7 3 2.3 2, 4
ALTI 35 10 3.5 —
AMY 14 7 2.0 12
AST 40 20 2.0 2, 5, 10
BUN 3 2 1.5 —
CA 5 3 1.7 2, 4
CCRP 12 2 6.0 —
CHOL 3 2 1.5 —
CK 14 7 2.0 2, 3, 4, 9
CKI 14 2 7 —
CRBM 3 2 1.5 —
CREA 20 10 2.0 5, 8, 15
CRP 3 2 1.5 —
a = The HCG and LHCG methods use an additional 10-fold dilution prior to taking the auto
dilute sample. Therefore a 2 µL autodilute sample for HCG or LHCG is equivalent to a 1:200
dilution. The instrument does calculations automatically.
b = For autodiluted HCG and LHCG results > 200,000 mIU/mL [IU/L], prepare a manual
dilution and enter the appropriate dilution factor on the Enter Sample Data Screen. The
instrument does calculations automatically.
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DBI 10 5 2.0 —
DBIL 31 10 3.1 5, 15
EZCR 6 2 3 —
FERR 40 2 20.0 —
GENT 3 2 1.5 —
GLU 3 2 1.5 —
GLUC 3 2 1.5 —
HCG,a,b 40 2 200.0b —
IBCT 25 12 2.0 —
IGA 10 2 5.0 —
IGG 10 2 5.0 —
IGM 10 2 5.0 —
IRON 40 20 2.0 —
LA 4 2 2.0 3
LDH 14 7 2.0 2, 3, 4, 8, 9, 10
LDI 8 2 4 —
LHCGa,b 40 2 200.0b —
LIDO 6 2 3.0 —
LIP 4 2 2.0 —
LIPL 3 2 1.5 —
LMMB 60 30 2.0 —
MBI 20 5 4 —
MMB 60 30 2.0 —
MYO 20 2 10.0 —
PHNO 4 2 2.0 3
PHOS 3 2 1.5 —
PTN 4 2 2.0 3
SAL 15 5 3.0 8, 10
a = The HCG and LHCG methods use an additional 10-fold dilution prior to taking the auto
dilute sample. Therefore a 2 µL autodilute sample for HCG or LHCG is equivalent to a 1:200
dilution. The instrument does calculations automatically.
b = For autodiluted HCG and LHCG results > 200,000 mIU/mL [IU/L], prepare a manual
dilution and enter the appropriate dilution factor on the Enter Sample Data Screen. The
instrument does calculations automatically.
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T4 16 4 4.0 3,5,7,10
TBI 10 5 2.0 —
TBIL 28 14 2.0 4, 7, 20
TGL 4 2 2.0 —
THEO 4 2 2.0 3
TOBR 3 2 1.5 —
TP 15 8 1.9 5, 7, 10
TPSA 40 2 20 —
UCFP 10 5 2.0 —
URCA 17 5 3.4 —
VALP 3 2 1.5 —
a = The HCG and LHCG methods use an additional 10-fold dilution prior to taking the auto
dilute sample. Therefore a 2 µL autodilute sample for HCG or LHCG is equivalent to a 1:200
dilution. The instrument does calculations automatically.
b = For autodiluted HCG and LHCG results > 200,000 mIU/mL [IU/L], prepare a manual
dilution and enter the appropriate dilution factor on the Enter Sample Data Screen. The
instrument does calculations automatically.
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WARNING: As with any sample run on the Dimension® EXL ™ system, you
must ensure that there is enough sample in the sample
container to run not only the requested tests but also any
subsequent reflex tests that may be automatically run.
Reduced Recommended
Dilution
Method Sample Volume AD Sample
Factor
(µL) Volume (µL)
ALT 20 10 2
ALTI 20 10 2
AMY 10 5 2
AST 20 10 2
CREA 15 10 1.5
DBIL 13 7 1.9
GGT 15 10 1.5
TBIL 12 6 2
TP 10 5 2
URCA 10 5 2
WARNING: As with any sample run on the Dimension® EXL ™ system, you
must ensure that there is enough sample in the sample
container to run not only the requested tests but also any
subsequent autodiluted tests that may be automatically run.
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Fluid Press F5: QC/Patient for patient results or QC results (as indicated by the type
of fluid that appears in the Fluid field). After selecting patient or QC results,
press F6: Next Fluid to see another fluid type.
(Specific Lot) Press F1: Set Period/Lot and type an asterisk (*) followed by the lot ID
number and press Enter. To return to viewing results for all lots of the
method, press F1: Set Period/Lot, type an asterisk (*) and press Enter.
4. Press F3 to select the view of this information you want to see. Three
views are available: a Result listing, a Histogram plot, and a
Levey-Jennings–type plot. Continue pressing F3 to move from one view
to another.
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Field Meaning
Result Test result (units are those appearing in the Units field).
Lot The lot ID of the Flex® reagent cartridge used to process the test.
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Asterisks (*) indicate that the data point has been deleted by the operator and
is not used in the information at the top of the screen.
When a patient fluid is selected, > and < signs indicate that the data point is
greater than (>) or less than (<) the limits shown in the Interval field.
When a QC fluid is selected, the > and < signs indicate that the data point
exceeds the rule (>) or is lower than the rule (<) shown in the Rule field.
Answer
Message
If the Fluid Type Is To Print Out
1 2
Patient The summary information (the top half of the screen). The Y N
summary information and supporting data for the method
and fluid combination. N
Histogram Plot
To create a histogram plot, five results are required for the method/fluid
combination. Each result must fall within the time period and the specific
reagent cartridge lot that appear on the top line of the screen.
From the Results Listing view, press F3: See Histogram.
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2. Press F5: QC/Patient until a patient fluid appears in the Fluid field.
•A green + is a result that is within the values in the Interval
field.
•A red x is a result that is outside the values in the Interval field.
•A blue * is a result that has been deleted by the user.
3. To see the result value and date for a specific point, press the right or left
arrow key to move a marker onto the point. The data for that point will
appear in the Marker field. A greater-than or less-than sign after the date
in this field indicates that the point exceeds (>) or is lower than (<) the
limits shown in the Interval field.
Printing L-J Patient Information
To print the L-J plot (only the last 31 data points can be printed), press
F8: Print.
To print the entire screen (all data points will be printed), hold down the Alt
key and press the letter P.
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Both of these printouts only use the system printer; they will not print to an
external printer.
Levey-Jennings QC Results Plot
QC plots are created using the ACTUAL mean and SD values unless you enter
EXPECTED mean and SD values, in which case the expected values are used to
create the plots.
1. From the Histogram Plot view, press F3: See L-J Plot (or from the L-J
Patients Results view, press F5: QC/Patient until a QC fluid appears in the
Fluid field).
2. Press F5: QC/Patient until a QC fluid appears in the Fluid field.
•A green + is a result that does not violate the rule in the Rule
field.
•A red x is a result that violates the rule in the Rule field.
•A blue asterisk * is a result that has been deleted by the user.
The mean for the data appears as a solid line in the center of the plot and
its value is listed on the scale at the left side of the plot. The dashed lines
above and below the mean are lines of standard deviation (either ±1 SD,
±2 SD, or ±3 SD).
The values shown on the scale at the left side of the plot are ±1, ±2, and
±3 SD based on the value shown in the SD field at the top of the screen.
For example, the mean shown in the screen above is 81.3 and the SD is
6.39; therefore the scale has ±1 SD or 87.7 (81.3 + 6.39) and 74.9 (81.3
– 6.39) respectively as its next values.
3. To see the result value and date for a specific point, press the right or left
arrow key to move a marker onto the point. The data for that point will
appear in the Marker field. A greater-than or less-than sign after the date
in this field indicates that the point exceeds (>) or is lower than (<) the
limits shown in the Interval field.
Changing the SD on the screen:
To reposition the dashed SD line to ±1, ±2, or ±3 SD:
1. Press the up or down arrow key. The dashed SD line is repositioned;
however, the SD values at the top of the screen do not change.
To change SD:
1. Press F4: Set Interval.
2. At the prompt, enter an SD level between 1.0 and 4.0. (You can select a
decimal SD by entering the letters SD after the decimal, for example, 2.5
SD.)
3. Press Enter.
The Interval, In, and Out field values at the top of the screen and the colored
data points will change to reflect this new SD; however, the dashed SD lines on
the screen remain at ±2 SD.
Printing L-J QC Information
To print the 2SD plot, press F8: Print.
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To print other SD plots that you have created on the screen, hold down the Alt
key and press the letter P.
Any deleted results on these printouts will appear as either an up or down
arrow, depending on whether the deleted result was above or below 2 SD.
Both of these printouts only use the system printer; they will not print to an
external printer.
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Field Meaning
Fluid The fluid for the patient or QC results shown on the screen. Use F5: QC/Patient
to go from patient to QC results and vice versa. Use F6: Next Fluid to display
results for another fluid. Only patient fluids that have been assigned ranges on
the Method Parameters screen will appear. Only QC fluids that have been
assigned ranges on the Quality Control Ranges screen will appear.
[dates] Time period brackets. If there is nothing entered in the brackets, all results in the
test result buffer for the method and fluid combination appear on the screen. If
the brackets contain a time period, only the results for that time period are
shown on the screen.
If a time period is entered, all screens (patient and QC) will display only results
that fall within this time period. This time period will remain in use on all
Method Review screens until you delete it or change it. Use F1: Set Period/Lot
as discussed under “Method Review Screen—Function Keys” later in this chapter
to enter a time period in this field.
Tests The total number of results in the test result buffer that match the method and
fluid on the screen (and, if specified, are within the specific time frame or are for
the specific reagent cartridge lot ID or crossover QC).
(Tests) In The number and percentage of results in the Tests field that are within the
Interval field shown on the screen.
(Tests) Out The number and percentage of results in the Tests field that are outside the
Interval field shown on the screen.
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Field Meaning
Interval The interval to which results are compared to determine the numbers and
percentages shown in the In and Out fields.
When a patient fluid is selected, the interval from the Method Parameters screen
for that method and fluid appears. When a QC fluid is selected, the interval from
the Quality Control Ranges screen for that method and fluid appears.
This interval field can be changed using F4: Set Interval as discussed under
“Method Review Screen—Function Keys” later in this chapter.
Units Results units. These units are taken from the Method Parameters screen for the
method.
Expected Mean Value only appears when QC results are selected. The value that appears (if any)
was entered by the operator on the Quality Control Ranges screen. The
expected mean is typically based on historical laboratory studies conducted on
that method. See “Entering QC Ranges” later in this chapter.
Expected SD Value only appears when QC results are selected. The value that appears (if any)
was entered by the operator on the Quality Control Ranges screen. The
expected SD is typically based on historical laboratory studies conducted on that
method. See “Entering QC Ranges” later in this chapter.
Actual Mean The actual mean is calculated using all the Tests field results. (It is not calculated
using only the In field results.)
Actual SD The actual standard deviation is calculated using all the Tests field results. (It is
not calculated using only the In field results.)
CV % The coefficient of variation percentage is calculated using all the Tests field
results. (It is not calculated using only the In field results.)
Rule The rule or constraint against which the results are compared. Each result is
compared to the Interval field to determine whether it exceeds or is below the
interval. This field is always “High/Low Interval” for patient results. For QC
results, in addition to High/Low Interval, one of six “Shewhart Rules” can be
selected. See a list of these rules and their meanings in “Rules Field Definitions”
later in this chapter.
Marker: ( ) This field contains the result and the date of the result corresponding to the
position of the marker on Levey-Jennings–like plots. See the “Levey-Jennings
Plots” discussion earlier in this chapter.
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F1: Set Period/Lot Used to enter a specific time period in Same as patient results. Also
brackets [ ] and a specific reagent allows crossover QC data to be
cartridge lot ID in the parentheses ( ) selectively displayed inside the
fields in the upper right corner of the parentheses ( ).
screen. See “Method Review Screen —
Fields” on page 62 of this chapter.
F2: delete Result Patient results cannot be deleted. This Deletes the QC result where the
(F2: Un-Delete) function key is disabled when patient cursor is positioned on the Data
results are displayed. screen or where the marker is
(Function key F2 is positioned on the L-J like QC plot.
always Delete For more information on deleting
unless the cursor and un-deleting results using this
or marker is function key, see “Reviewing QC
positioned on a Results” on page 68 of this chapter.
data point that has
been deleted).
F3: See Data Used to display the results as a list, a Same as patient results.
(F3: See histogram, or a Levey-Jennings like
Histogram) plot. These views must be displayed in
(F3: See L-J Plot) sequential order.
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F4: Set Interval Used to select results within a specific Same as patient results. Also
user-defined interval/ To enter a new allows a decimal SD to be entered.
range in the Interval field, press F4: Set See “Levey-Jennings Plot Views” on
Interval and at the prompt enter the page 59 of this chapter.
low range for the new interval and then
the high range. Press Enter after each
entry. The In and Out fields will update
automatically based on the new range.
Note: When Using
F4: Set Interval, all
Method Review Screens
for this method/fluid
combination will use
this interval.
Note: The Interval field shows
the new interval as the
result histogram and L-J
plot views are displayed
for the method and
fluid combination. It
reverts to the
appropriate intervals
from the Method
Parameters screen upon
exiting and reentering
the Review screen or
when another patient
fluid or method is
selected.
F5: QC/Print Used to change displayed results from Same as patient results.
patient to QC and vice versa.
F6: Next Fluid Used to display results for the next Used to display results for the next
patient fluid type. QC fluid type.
F7: Show mAU Used to toggle result units between Does not appear on the QC display.
Show Conc mAUs and concentration units. When
mAU’s are selected, the Interval field
will always be
0.0 - 9999.9 (The mAU information is
typically used for troubleshooting).
F7: Next Rule Does not appear on the patient results Used to change the Rule field
display. selection. There are 7 possible rule
selections, 6 of which are
Shewhart Rules. See “Rules Field
Definitions” on page 67 of this
chapter.
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F8: Print Used to print out results information Same as patient results.
appearing at the top of the screen using
the system printer. (This does not print
to an external printer).
1. Press F8: Print.
2. Answer the prompt with a Y to
print out only the information
listed at the top of the screen, or
with an N to print out a report that
contains all the individual results
in that method’s test results buffer
on this instrument.
3. Press Enter.
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High/Low Interval Any result that falls outside the range listed on the Quality Control Ranges
screen for that fluid.
any point > 2 sd Any result that falls outside ±2 standard deviations from the mean. This is
termed a “warning” rule and requires further evaluation to judge whether
the data presents a problem.
any point > 3 sd Any result that falls outside ±3 standard deviations from the mean. A
violation of this rule suggests systematic error.
two consecutive > 2 sd Two consecutive results that fall outside ±2 standard deviations from the
mean. A violation of this rule suggests systematic error.
four consecutive > 1 sd Four consecutive results that fall outside ±1 standard deviation from the
mean. A violation of this rule suggests systematic error.
two consecutive > 4 sd The absolute difference between two consecutive results is greater than
or equal to 4 standard deviations. A violation of this rule suggests random
error.
ten consecutive Ten consecutive results above or below the mean. An above/below mean
violation of this rule suggests systematic error.
Note: These rules use the expected mean and SD values, unless
actual mean and SD values are entered. If entered, the actual
values are used to create the plots. These rules consider only
results “within” a given material and not across materials. To
review results across materials, print out a plot of both levels
and then visually examine them.
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Reviewing QC Results
When reviewing QC results, you may want to view the data without including
all of the data points. You can delete specific QC results.
Any deleted results are not included in or used to calculate the values in the
fields at the top of a Method Review QC screen. These results are not
permanently deleted from the QC test result buffer, so they can be undeleted.
Note: Patient results cannot be deleted.
2. To undelete a deleted result, move the cursor to the result and press
F2: Un-Delete.
2. To undelete a deleted result, move the cursor to the result and press
F2: Un-Delete. When a result is undeleted, it is compared against the
current rule in the Rule field and becomes a red x or a green +
accordingly.
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Connection Between the QC Results Listing Screen and QC L-J Plot View
Any deleted/undeleted result made on the Results Listing screen is also
deleted/undeleted on the L-J plot view and vice versa.
The result appears on the Results Listing screen with an asterisk (*) in the far
left column to indicate that it has been deleted. If the deleted result also
exceeds the current rule shown on the display, a > appears in the left column.
If the result is lower than the current rule, a < appears in the left column.
A deleted result is not used in any of the calculations shown at the top of the
screen. Therefore, when a result is deleted, the Tests, In, Out, Actual Mean,
Actual SD, and % CV fields all change accordingly.
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HIL Feature
Note: If the Dimension® EXL™ system is connected to an LIS, ensure
that the LIS is able to receive results for tests it did not request
originally. Check with your local LIS consultant.
The HIL feature, which is based on the spectral characteristics of a serum or
plasma sample, provides an index that can alert you to potential interference
from hemolysis, icterus, and lipemia in the sample, where:
H = hemoglobin resulting from lysis of red blood cells
I = icterus resulting from endogenous bilirubin
L = lipemia or turbidity caused by insoluble lipids
The HIL feature can be programmed to run automatically in an Operating
Mode that best suits the needs of your laboratory, or by request on individual
samples. Once programmed, the instrument automatically pipets 20 µL of
sample into an empty cuvette along with system water. Spectral absorbance
measurements, taken at 405nm (hemoglobin), 452nm (bilirubin), and 700nm
(turbidity), are used to generate a sample-specific HIL Index. The HIL Index
appears on the report slip as a three-digit value where:
• 1st digit = H index
• 2nd digit = I index
• 3rd digit = L index
Each index value correlates to an approximate concentration range in mg/dL
for each of the potential interferents, as specified in Table 10-2. HIL is not
processed if the maximum of 36 tests for a sample are ordered.
Table 10-2: HIL
H I L
Index
Hemoglobin (mg/dL) Bilirubin (mg/dL) Intralipid ™ (mg/dL)
1 H ≤ 25 I ≤ 2 L ≤ 25
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The following general conditions are required for HIL to be run automatically:
• Sample must be serum or plasma.
• Sample must be undiluted (dilution does not eliminate spectral
interference).
• Operating mode must be set to ON or AUTO-ON.
• If the operating mode is AUTO-ON, Alert Index values between 2 and 6
must be entered in the HIL Setup screen.
• Sample Mode must be primary tube, bar code tube, sample cup or SSC (as
specified in the selected operating mode).
• HIL will not run automatically in the "limited cup - no level sense" (sample
volume may be limited).
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HIL Setup
To set up the HIL feature, select an Operating Mode. The selections for
operating modes are listed in Table 10-3. If the mode is "AUTO-ON -Tubes,
Cups, SSCs" or "AUTO-ON -Tubes, Cups", you must also enter HIL Alert Index
values.
WARNING: As with any sample run on the Dimension® EXL ™ system, you
must ensure that there is enough sample in the sample
container to run not only the requested tests but also any
subsequent tests that may be automatically run.
To specify parameters for HIL setup:
1. With the instrument in Standby, display the HIL Setup screen by pressing:
F5: Process Ctrl > F8: More Options > F6: HIL Setup. A password is
required.
2. Press F1: Next Mode to display the Operating Mode that best suits your
laboratory's needs. Press F2: Store.
Table 10-3: Operating Modes
Operating Modes
AUTO-ON -Tubes, Cups, HIL is run automatically when a method with an alert index between 2 and
SSC's 6 is requested and the sample mode is primary tube, bar code tube, sample
cup or SSC. The test report displays the "HIL Interf" message for an affected
method if any of the measured HIL index values is greater than or equal to
the corresponding Alert Index for that method.
AUTO-ON Tubes, Cups HIL is run automatically when a method with an alert index between 2 and
6 is requested and the sample mode is primary tube, bar code tube or
sample cup. The test report displays the "HIL Interf" message for an affected
method if any of the measured HIL index values is greater than or equal to
the corresponding Alert Index for that method.
ON HIL is run automatically and reported for all serum and plasma samples
when the sample mode is primary tube, bar code tube, sample cup or SSC.
The test report does NOT display the "HIL Interf" message for an affected
method.
OFF HIL is not run automatically for any sample. However, you can request HIL
by including it in the list of tests requested by LIS or by pressing the HIL test
key when ordering tests manually. The test report displays the HIL index,
but does NOT display the "HIL Interf" message for an affected method.
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e. To deactivate the HIL feature for a method, enter zero (0) in all the
Alert Index fields for that method.
f. To prevent inappropriate flagging of samples which are not
hemolyzed, icteric or lipemic, the system does not accept an Alert
Index value of 1.
4. When all required HIL Alert Index values are entered, press F2: Store. To
view a list of methods and HIL Alert Index values:
a. Press F5: Show All to display all HIL eligible methods.
b. Press F5: Show Active to display only methods with stored alert
indexes.
5. To print a list of methods and HIL Alert Index values, press F4: Print.
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You can configure the STAT Status feature to alert you to any or all of these
conditions. To configure the alerts:
1. Press the STAT Status alert key to display the STAT Samples screen.
Figure 10-24: STAT Samples Screen
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3. Move the cursor to the required field. Press the Enter key until your
choice is displayed or type the required number for time fields, then
press Enter. When finished, press Exit.
Field Choices
Sound audio alarm when any STAT OFF alarm will never sound
alert is triggered ON alarm will sound for all configured alerts
Alert when a STAT sample is OFF alert key will not turn yellow when sample processing is
available finished.
ALWAYS alert key will turn yellow when any STAT sample is
finished processing.
SELECTABLE allows you to select a specific sample and press the
F8: Complete Alert key:
• If the sample line is white (alert OFF) when you press F8, it
turns yellow while processing and blue when finished.
• If the sample line is yellow when you press F8, it turns white
(alert OFF).
Alert when a STAT sample is OFF alert key will not turn red when sample processing is finished
available but has an error with no with an error and no result
result ON alert key will turn red when sample processing is finished with
an error and no result
Alert when a STAT has been OFF alert key will not turn red for samples not started
entered but not run in a specified ON alert key turns red if a sample does not start processing within
time the specified time period
Time from STAT entry to alert - in Can be used only if the previous entry is ON. Enter the number of
minutes minutes (1 - 60) a STAT request can wait before the Not Started
alert is triggered.
Time for STAT alerts to be Enter the number of minutes (1 - 120) that an alert will be
displayed - in minutes displayed on the STAT Samples screen. After the time has elapsed,
the information is removed from the display.
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Configuring QC Alerts
1. Press the QC Alert key. On the screen that appears, press F4: Config
Alerts.
2. For each parameter, move the cursor to the required field and press
Enter to toggle between ON and OFF
3. If you turn ON the Alert when QC expires, enter a number between 1 and
240 to define the time interval for expiration.
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Field Explanation
Report Title This creates the header that appears on your printed test report.
Enter a title for your report (up to 30 characters).
System Printer Indicates the status of the system printer. Press F1: Sys Printer to
select another status.
Spacing between reports Enter the number of centimeters of blank paper you want between
printed test reports.
Minimum number of lines Enter how many test result lines will appear in all test reports.
External Printer Indicates the status of the external printer. Press F2: Ext Printer to
select another status.
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Header Description
Report Title & Banner The date and time the report was printed are placed on the last line of the
label.
Patient Header The label section fields can be chosen from any information on the Enter
Information Sample Data Screen
Test Result Line - Header This section consists of only two lines, both use the same line and column
positioning data. This section sets the headers for the data.
Test Result Line - Data The Data Item column contains results information that can be selected for
the report.
Note: The field “Chemistry” means that the full name of the method
(i.e., Triglyceride) will be printed on the report; the field “Test”
means that the method abbreviation will appear on the
report.
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The above settings should produce the output shown in Figure 10-26.
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Note: Follow the dashed lines to view how the line and column
specifications relate from the format to your printout. An
example of how the Line and Column fields relate is shown
for the Hospital field.
Note: Use “-1” in the Column field to prevent printing. This prevents
the “Test” labels from appearing on the printout. In the
example in Figure 10-26, the user wanted to print the full
“Chemistry” name but not the abbreviation.
Note: To align the title entries use spaces. The “^^^^” in
Figure 10-26 indicate spaces added using the space bar to
center the titles.
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Each Dimension® EXL ™ integrated chemistry system can collect its absorbance
readings by method and lot of reagent, and then use this data to establish
instrument-specific limits for that method. Any test result that exceeds these
limits on the particular Dimension® EXL ™ instrument will generate an
“abnormal assay” (abnl assay) flag on the test results printout. If this occurs,
the result should not be reported and the sample should be rerun. This feature
is not available for all methods.
The Result Monitor screen is divided into two sections. The left side (Limits) is
used to activate a method and to enter/change method-specific limits.
Periodically, as a result of internal testing, Siemens may communicate
revisions to the Result Monitor limits. The right side (Accumulated Results) will
be filled in by the instrument for each method that has been activated.
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Limits Side
Includes an A column and a B column, depending on whether the methods use
one or two monitoring checks. The fields in each column define the limit using
either percentage or SD limits. Above Mean Factor numbers are given as a
percentage factor of the mean absorbance result. For example, an upper limit
of 1.20 indicates that the flag will be set if an individual results monitor is
greater than 120% of the mean. (A lower limit of 0.75 indicates a limit set at
75% of the mean.) For the Mean Plus/Minus SD fields, the number entered is
the factor times the SD to define the limit around the mean. For example, a
Mean Plus/Minus SD factor of 6 indicates that the limits are 6 SDs above and
below the mean absorbance value.
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Method A B A B A B
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Method A B A B A B
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The Bar Code Configuration section is used to read and interpret the barcode
system used by your laboratory and to set certain instrument actions when the
barcode is read. This section is also where you indicate whether to translate
certain LIS method names to Dimension® EXL ™ system method names. Turn
these functions on as needed for your LIS compatibility.
The Test Scheduling and Reporting section is used to define information about
test priority scheduling and test reporting on the instrument.
Note: System configurations have already been set to meet
laboratory requirements during instrument installation. Do
not change any instrument option with out laboratory
supervisor approval.
Table 10-6: Sample ID Information Fields
Field Explanation
Default Fluid The Fluid field on blank Enter Sample Data screens defaults to this entry.
Use F8: Next Setting to select other fluids.
Sample Edit Indicates the type of sample container that will be assigned to all
downloaded samples that are assigned segment positions by the
operator from the Sample Status screen. Use F8: Next Setting to select
a sample container type.
If this field is set to No Default, sample positions cannot be assigned for
downloaded samples using the Sample Status screen.
Pediatric Tube Segments Indicates those segments that have been configured for Pediatric tubes.
Move the cursor to this field, press F5: Add Segs, enter the segment
letters and press Enter, then press F7: Store. The Mode field on the
Enter Sample Data screen defaults to PED Tube when positions in these
segments are entered.
PED Tube I.D. (mm) The inside diameter in millimeters of the PED tube used by the
laboratory.
SSC Indicates segments that have been configured for SSC use. Move the
cursor to this field, press F5: Add Segs, and use the keyboard to enter
the segment letters. Press Enter, then F7: Store. The Mode field on the
Enter Sample Data screen defaults to SSC when positions in these
segments are entered.
SSC I.D. (mm) The inside diameter in millimeters of the SSC. The inside diameter of the
SSC is 8 mm.
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Field Explanation
Priority Panel (schedule) Allows specific tests within samples to be given a higher scheduling
priority than the sample itself. This enables critical tests to be processed
in a STAT-like manner while the remainder of the tests for the sample
are processed with the priority given on the Enter Sample Data screen
(or downloaded through a host computer). When a priority panel
schedule is requested on a sample, the system raises the priority of the
tests in the designated panel one level above the other tests requested
on that sample. NOTE: The priority scheduling option is not active for QC
samples or samples that include multiple test requests of the same
method. All tests in the priority panel must be ordered for scheduling to
occur.
Enter the number of the panel key that you have defined for priority
scheduled tests. Then select “STAT only” or “All samples.”
• If “STAT only” is selected, the priority panel is performed only on
samples that were entered as STAT.
• If “All samples” is selected, the priority panel is performed on all
samples, regardless of their priority.
Priority Panels:
The Priority Panel (schedule) and Priority Panel (report) fields do not
need to have the same information in them. You could define different
panels for use in each of these fields. For example, you could define a
priority panel (schedule) of ACP so it would be scheduled first, and
define the priority panel (report) to be GLU and LYTES so that these two
results print out as soon as they are available.
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Field Explanation
Priority Panel (report) Enables the system to print a test report for a sample as soon as all the
tests in the panel are completed.
All tests in the priority panel must be ordered for the report to print.
Before enabling priority panel reporting, you must ensure that the host
computer is capable of receiving two reports for the same sample. If you
are not sure of this, check with your local host computer consultant.
In addition, when the remaining tests of the sample are completed,
another report is prepared that includes all tests (including the priority
panel tests) requested on the sample. The priority of the priority panel
report printout is STAT, so that it can be distinguished from the final
sample report.
Download Pretreats Indicates whether or not samples with pretreatment tests can be
downloaded from your laboratory LIS. Use F2: Pretreats to select YES or
NO.
Bar Code Label Format The format of the barcode used by your laboratory. Use F8: Next
Setting for other formats recognized by the system.
Label Length The field length of the barcodes used by your laboratory. This field can
be zero or a number from 3 to 12.
Leading Zeros Indicates whether or not the system recognizes zeros that precede a
barcode. If YES is selected, you must enter all the zeros that precede the
barcode when entering a Sample No. on the Enter Sample Data screen.
Use F3: Zero's Yes/No to make your selection.
Translate TCO2 to ECO2 If turned ON, the system interprets an LIS request for test method TCO2
as a request for test method ECO2.
Translate Low Volume If turned ON, the system interprets LIS requests for test methods HCG,
Test Method Names MMB and TNI as requests for LHCG, LMMB, and LTNI when you use
reduced test Flex® reagent cartridges for those methods.
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Fields Explanation
Total Results Includes all patient tests that produced a reportable result. Test results
with an “aborted test,” “no reagent,” or “not calibrated” processing
message are not counted because they did not consume reagent.
Conditional Results Includes all patient tests that produced a reportable result and included
an error code with the result (any processing messages except for those
listed above in Total Results). The Conditional Results count is included in
the Total Results count.
QC/Calib Includes all QC and Calibration tests that produced a printed result and
consumed reagent. The QC/Calib count is not included in the Total
Results count.
Last Saved The count that was in the Total Results column when F8: Save Counts
was last pressed.
Tests Since Last Save The difference between the Total Results column and the Last Saved
column.
Last Save Date The date and time when F8: Save Counts was last pressed.
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SerumQC1
SerumQC2
QC level
SerumQC3
UrineQC1
UrineQC2
Prod Name The name entered by the operator in the Patient Name field (on Enter Sample Data
screen) or downloaded from the LIS.
QC Lot # The lot number entered by the operator in the Sample No. field (on Enter Sample
Data screen) or downloaded from the LIS.
Flex Lot # Lot number of the Flex® reagent cartridge used in the QC run.
Note: LYTE will appear in this field for Na, K, and Cl.
Inst ID Unique identifier entered in the Instrument ID field in the Communication Set Up
screen.
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Patient Name Name of the patient entered in the ENTER DATA screen or downloaded from LIS.
Sample No. Sample number entered on the ENTER DATA screen or downloaded from LIS.
Inst ID Unique identifier entered in the Instrument ID field in the Communication Set Up
screen.
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# Description
1 Keys 1-10: Four test methods can be assigned to each of these keys.
Note: If fewer than 20 methods are run in the laboratory, you can
program a test method to position 1 on test keys 1-10 and
16-25. Tests can be selected without having to use Shift,
Control or Alt keys as well.
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User-Defined Methods
This section contains all the information needed to understand and operate
the User-Defined Method feature on the Dimension® EXL ™ integrated
chemistry system. With this feature you can define your own methods using
reagents that are not purchased from Siemens. You define these methods by
choosing the characteristics that fully describe an analysis. Up to ten methods
can be defined and stored.
Siemens provides validated instructions for using certain Emit® assays. Contact
the Technical Solutions Center for the method-specific Application Sheet.
Methods defined with the User-Defined Methods feature are requested for
sample processing in the same way that Siemens methods are requested. They
can be processed along with Siemens methods in random, batch, or profile
modes.
Before using User-Defined Methods, you should be familiar with the basic
operation of the Dimension® EXL ™ system because the procedures for
calibrating, performing quality control, and running patient samples are the
same as for Siemens methods.
To program and run a user-defined method, you will need to perform the
following 12 steps in sequence:
1. Enter the method reaction parameters on the “Identifying the Method” on page 102
User-Defined Method screen. “Defining the Reagent and Sample Deliveries” on
page 103
“Defining the Photometry Reading Times” on
page 105
“Defining the Flex® Cartridge Configuration” on
page 106
2. Program your calculations on the template “Defining the Calculation” on page 108
and calculation screens.
5. Store the method reaction parameters and “Storing a User-Defined Method” on page 110
calculation routine.
7. Enter the method parameters under the “Entering User-Defined Method Parameters” on
System Configuration screen. page 110
9. Load a Flex® reagent cartridge. “Loading the Flex® Cartridge” on page 111
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Customer Responsibility
The Customer assumes all responsibility for the selection of the proper
reagents and entering the proper test parameters, use of the proper test
protocol, correctness of the test results, and any associated errors or
omissions.
Warranty
SIEMENS EXPRESSLY DISCLAIMS ALL WARRANTIES WITH RESPECT TO THIS
USER-DEFINED METHODS PRODUCT WHETHER EXPRESS OR IMPLIED,
INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
Since Siemens does not manufacture the reagents that our customers may use
in the user-defined Flex® reagent cartridge, the warranty for the Dimension®
EXL ™ integrated chemistry system does not extend to the performance of
user-defined reagents (including user-defined test results or standard
Dimension® EXL ™ system test results that are affected by user-defined
testing), their effect on the system operation and types and frequency of
maintenance, or their effect on operator safety.
WARNING: Never assign the same name to more than one method.
This could result in erroneous or misleading test results.
4. Press F1: Next Select. to select a mode.
5. Press F1: Next Select to select a standard curve.
Table 10-8: Method Identification Fields
Field Information
Channel Ten channels (numbers 1–10) are available for user programming.
Name User-defined method names always start with an X. You can add
up to three additional alpha-numeric characters (XABC, XAB1,
etc.). Each user-defined method must have a different name.
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Reagent Delivery R1
1. Enter a delivery time (in seconds) for the reagent to be delivered. The
delivery time for R1 is preset and cannot be changed.
2. Select a component (Component 1) for the reagent delivery by pressing
F1: Next Select.
3. Enter the volume of Component 1 to be added to the cuvette.
4. If your method requires more than one component, repeat steps 2 and 3
for Components 2 and 3 as necessary.
5. Enter the volume of chase to follow the reagent delivery.
6. Select a mix level for the reagent delivery by pressing F1: Next Select.
Note: All methods must specify a volume for at least one
component of R1.
Sample Delivery
1. Enter the volume of sample to be added to the cuvette. Sample volumes
can range from 2 µL to 60 µL.
2. Enter the volume of chase to follow the sample delivery.
3. Select a mix level for the sample addition by pressing F1: Next Select.
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Field Explanation
Component A component is a reagent that is stored in a well of the Flex® cartridge. The
cartridge may contain up to five different components, but a component may
be stored in more than one well. You may add as many as three components in
any single reagent delivery. Components are designated by the letters A–E and
correlate to well positions 1–5 in the Flex® cartridge. Refer to “Filling a Flex®
Cartridge” for details on specifying the location of components within a
cartridge. No order of use or delivery is implied by these letters.
Volume Enter volume in increments of whole µL. The total sample volume delivered
(including chase) must be less than 100 µL. Total volume, V, in the cuvette
(includes reagent, chase, and sample volumes) must be between 350 and 500
µL. We recommend that you use at least 15 µL of chase per reagent delivery to
ensure that the reagents are adequately washed from the probe.
Chase Chase is a diluent (water) supplied by the instrument to flush the reagent lines,
sample probes, or systems after an addition. Enter any amount of chase
(water) that is consistent with the volume limitations described above and the
mix strength described below.
Mix Describes how vigorously to mix the reagent components (or sample) and
chase. GENTLE, MODERATE, STRONG, or NONE are the available choices. The
mix strength involves a combination of how long the solution is mixed, how
much energy is used, and how many pulses are applied. For gentle mixes, the
ultrasonics pulse for longer times at a lower energy level, while strong mixes
occur over a shorter time period with a higher energy level.
When selecting a mix level you should:
• be careful to prevent foaming.
• consider the chemical properties (such as viscosity) of the reagents and
sample.
The reagent chase volume must be at least 20 µL when a reagent mix is
requested. The sample chase volume must be at least 10 µL when a sample
mix is requested.
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1. Enter a time (in seconds) for the first photometry reading (P1).
P2 0 (zero) to 675 seconds, but must be later than the first reading (P1).
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1. Enter the component location for each well in the Flex® cartridge by
putting the letter identification of the component under the appropriate
cartridge configuration number (well number 1, 2, 3, 4, 5, or 6) where it
is located in the Flex® cartridge.
a. To do this, position the cursor in the parentheses under the well
number and press F1: Next Select until the proper letter appears.
2. Enter the number of tests for each well. The total number of tests must
be equal for each component (but not necessarily for each well) within a
Flex® cartridge.
3. Enter the Well Life, which is the number of hours that each well will
remain stable after the well has been punctured by the reagent probe.
WARNING: The Well Life, On-Board Life, and Calibration fields should be
carefully determined prior to routine use of a user-defined
method.
4. Enter the On-Board Life, which is the number of hours that the Flex®
cartridge remains stable after it has been placed in the instrument.
5. Enter how often this method must be calibrated (in hours).
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Field Explanation
Component Reagent component designation and well location. Reagent components can
be located in one or more wells. Nominal Flex® cartridge dead volume is 200
µL per well when used with a user-defined method. The maximum volume of
each well is 4.0 mL.
Relates to the number of test volumes in a cartridge well. This is the number of
tests available for all components in a cartridge. For example:
CARTRIDGE CONFIG 1 2 3 4 5
6
COMPONENT A B B C
NUMBER OF TESTS 20 10 10 20
Number of Tests Notice that, as required, components A, B, and C each have a total of 20 tests
available.
Well Life The number of hours that a reagent (a component in a given well) remains
stable after the well has been punctured by the instrument. This can be up to
760 hours. The default time is 72 hours.
On-Board Life The number of hours that reagents in a cartridge remain stable after the
cartridge has been placed on the instrument. This can be a maximum of
760 hours. The default time is 720 hours (or 30 days).
The instrument maintains the cartridge at 2°–8°C as with all other reagents.
Calibration The maximum number of hours allowed between calibration. This can be a
maximum of 8760 hours (or 365 days). The default time is 2160 hours
(or 90 days). Calibration will remain valid within the same lot number of a
method, as with Siemens chemistries.
Note: You can assign up to 99 tests per well in the Flex® cartridge.
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Field Explanation
Measuring Filter 293, 340, 383, 405, 452, 510, 540, 577, 600, 700, or NONE.
Blanking Filter 293, 340, 383, 405, 452, 510, 540, 577, 600, 700, or NONE.
Depletion Factor The instrument calculates a P1/P2 rate and a P2/P3 rate. If these rates differ
from each other by more than a given percentage (the depletion factor you
entered), an absorbance error message will appear on the printed test
results. A depletion factor must be entered on three-point calculation
templates.
Dilution Indicates the weighting factor or multiplier that compensates for the dilution
of the sample. This applies when sample or reagent is added between
photometry readings.
For example:
• R1 (at –60.0 seconds) involved the addition of 370 µL to the cuvette.
• P1 is at –30.0 seconds (the volume in the cuvette is 370 µL at this time).
• S1 (30 µL) the addition of 30 µL of sample occurred at 0.0 seconds.
• P2 is 65.0 seconds after the sample was added
(Total volume in the cuvette is now 370 + 30 = 400 µL.)
The dilution value is 400 µL divided by 370 µL (1.081).
The dilution value may be positive or negative. An undiluted sample would
have a dilution value of:
• 0 or 1.0 for a rate method
• 1.0 for an end point method
Initial Optical No limitations. Enter an IOD (in mAU) in the numerical field.
Density (IOD) Next to this field are parentheses where you must indicate if you want an
absorbance error message to be printed on the test results report. Select
BELOW if you want the message to appear when results fall below the IOD
you entered. Select ABOVE if you want the message to appear when results
fall above the IOD you entered. Select INACTIVE if you do not want a
message to be printed.
Final Optical No limitations. Enter an FOD (in mAU) in the numerical field.
Density (FOD) Next to this field are parentheses where you must indicate if you want an
absorbance error message to be printed on the test results report. Select
BELOW if you want the message to appear when results fall below the FOD
you entered. Select ABOVE if you want the message to appear when results
fall above the FOD you entered. Select INACTIVE if you do not want a
message to be printed.
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CAUTION: Do not try to use an eight-well Flex® cartridge because this will
damage the reagent probe.
Field Information
Method Enter the same name that you have already assigned to this method on
the Method Parameters screen
Sequence number A unique, five-digit number. This number must be different for all
reagent cartridges for this method.
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To Request This
User-Defined Test Press this Key Combination
Method
X01 Control/GGT
X02 Control/GLU
X03 Control/LDH
X04 Control/LYTES
X05 Control/NA/K
X06 Control/PHOS
X07 Control/TBIL
X08 Control/TP
X09 Control/TRIG
X10 Control/URCA
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Field Explanation
Method () The method name appears in this field when the method is selected. The
description “6 well” for the Flex® cartridge is always displayed within the
parentheses.
Filters The 3-digit fields to describe the wavelengths to be graphed on the kinetics
screen.
1st field Shows which single wavelength to display on the graph. Press F6: Filter
Display to change this field. If you want to display more than one
wavelength, choose “bic” for bichromatic, or “---” to display all ten
wavelengths.
2nd and 3rd fields Initially show the Measuring Filter and Blanking Filter wavelengths you
chose when programming the method. These wavelengths appear on the
graph if you chose “bic” for the 1st field. To change the first wavelength,
press F3: 1st Bichrome; to change the second, press F4: 2nd Bichrome.
If a single wavelength or all ten wavelengths are chosen, these last two
fields display the wavelengths programmed into the method. Changing
them does not affect what is displayed on the graph. If you choose
turbidimetric mode when identifying your method, an asterisk (*) follows
the Filters field until the kinetics reaction has started. After the kinetics
reaction has started, the running time of the assay follows the Filters field
regardless of which mode is selected.
Scale mAU Describes the absorbance scale (in mAU) of the y-axis.
Filename A file name appears in the Filename field when the data is archived. For
user-defined methods, the file name is always “kinetics.ar” and the system
saves the most recent study. Press F5: Archive Data to archive the data.
Marker You can display up to two markers (blue vertical lines, x and o) on the graph.
You can also move these markers during the reaction but only to the point
where the reaction has progressed. Move the cursor to the Marker field and
press Enter to select the marker(s) that you wish to view or move. Use the
arrow keys to move the marker(s) that you have selected. You can continue
to select and move markers throughout the reaction process.
mA, bic dmA mAU with respect to a bichromatic reaction, specifically the change (delta)
in mAU, x and o.
mA/min With respect to bichromatic reactions, this is the change (delta) in mAU per
minute.
Note: Changing filters using F3, F4, and F6 does not affect the
programmed method. They only change the wavelengths
displayed on the Method Kinetics screen that you are
viewing, but do not change what has been programmed in
the method itself.
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Cartridge Configuration:
Well #
Component
#tests/well
Reaction Kinetics:
Reaction Timeline
Event
Time
Volume: Component 1
Component 2
Component 3
(Reminder: Volume in the cuvette must be >350 µL whenever a photometer reading is programmed.)
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CAUTION: Do not load the Flex® cartridge into the automatic loader until
this prompt appears.
6. Observe the messages as the method reaction progresses.
After the time clock has started, you can stop the reaction at any time by
pressing F1: Stop Assay.
You can also change the filter display during the reaction and the graph
automatically updates to the new wavelengths.
7. After the reaction is complete, you can:
a. Choose a print option:
1) Press Control/P key combination for a printout of the screen.
2) Press F8: Print (with 1 or 2 wavelengths displayed) for a
graph of the active wavelength.
3) Press F8: Print (with all wavelengths displayed) for a
complete data dump of all readings for all wavelengths.
4) Make note of any data that you want to edit into the
User-Defined Methods screen for that method.
8. Press Exit to leave the Method Kinetics screen. The instrument prompts
you to remove the investigative-use Flex® cartridge.
9. Remove and discard the investigative-use Flex® cartridge.
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Programming Terms
The Dimension® EXL™ instrument user-defined software application provides a
versatile method of specifying how raw photometric data is transformed prior
to conversion to analyte concentration through the method’s standard curve.
Examples of simple transformations would include bichromatic endpoints and
two-point rates. More complex transformations include polychromatic sums,
volume-corrected blanking for endpoint reactions, and checking for substrate
depletion through comparison of early/late reaction rates.
The capability provided by the transformation program is similar to the
functionality provided by a four-function calculator. The four common
arithmetic functions—add, subtract, divide, multiply—are provided, as well as
parentheses. Twenty-six temporary memory registers are provided for the
storage of intermediate results. Functions are available for calculating
monochromatic and bichromatic rates and endpoints from the raw
photometric data arrays.
Programming Structure
All programs must have a left brace ({) as the first character and a right brace
(}) as the last. At least one RETURN statement is required to forward
meaningful results from the calculation.
Enclosed within the braces are program statements. Statements are used to
assign intermediate results to registers, test logical conditions, set error codes,
and return transformed mAU to the system.
Implementation
The MAU Calculation screen provides the 25 lines in which to enter a
transformation program. The input is in the form of a simple programming
language, which provides functions to retrieve raw data from the photometric
data arrays, algebraic statements to transform that data mathematically, and
test statements (if/else) that can be used to set error flags. In addition, there
are 26 registers labeled A–Z that can be used for temporary storage of
intermediate results. The final result is RETURNED for input into the standard
curve transformation.
For instance, the program
1. {
2. A = BICH(P1,340NM,383NM);
3. RETURN A;
4. }
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Statements
Statements can take any of the following forms:
• register = numerical expression;
• SET errorcode ERROR;
• RETURN numerical expression;
• { statement1; statement2; ...; statement N; }
• IF (logical expression) statement
• IF (logical expression) statement ELSE statement
Examples of these types of statements appear below and on the next page.
register = numerical expression
This statement is used to assign an intermediate result to a register. Register
can be any of the 26 general registers A,B,C...X,Y,Z. Numerical expressions are
described later.
SET errorcode ERROR
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This statement is used to set error codes on the report slip. Accepted values for
errorcode are ABSORBANCE, ARITHMETIC, MEASUREMENT, and REACTION.
For simplicity, the last error set is the one that is forwarded for publication.
Therefore, the programmer can establish error precedence. If an arithmetic
error is detected by the system, the system will automatically forward an
ARITHMETIC error with no numerical result.
RETURN numerical expression
This statement is used to forward a transformed mAU to the system. The
numerical expression is frequently a register, but may be any numerical
expression (refer to “Expressions” later in this chapter). Once a RETURN
statement is encountered in a program, no further statements are executed.
{ statement1; statement2; ...; statement N; }
The statement syntax is a compound statement, used to group several
statements. This syntax is most useful when multiple simple statements must
be executed as a group, as within the context of an IF or IF/ELSE statement.
IF (logical expression) statement
This statement is used to test logical conditions and execute a statement if the
logical condition is TRUE. IF statements are most often used to conditionally
execute SET errorcode ERROR statements, as in this substrate depletion
scenario:
1. {
2. A = RATE(P1,P2,340NM,383NM);
3. B = RATE(P2,P3,340NM,383NM);
4. IF (B < 0.80 * A) {
5. SET ABSORBANCE ERROR;
6. RETURN A;
7. } ELSE {
8. RETURN B;
9. }
10. }
The first statement calculates the rate of reaction between readings P1 and P2,
and assigns it to register A. The second statement calculates the rate between
readings P2 and P3, and assigns it to register B. The IF statement will flag an
absorbance error (if the later rate is less than 80% of the earlier rate) and
RETURN the value of the early rate as the transformed mAU value. Otherwise,
no error is set, and the later rate in register B is returned.
Note that the TRUE clause of the IF/ELSE statement contains a compound
statement, which is used to group the SET and RETURN statements into a
single clause.
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Expressions
Two classes of expressions are possible, depending on the kind of value
produced by the expression. The first class, referred to as numerical
expressions, produce numerical results that can be assigned to registers or
returned as values. The other class, called logical expressions, produce logical
results from Boolean operations. Logical expressions are used exclusively
within IF statements. The output of a logical expression cannot be used to
assign values to registers, nor can it be returned.
Numerical Expressions
Numerical expressions allow the user to combine values from function calls,
registers, and constants together using the arithmetic operators *, /, +, and – .
The precedence of these operators corresponds to common usage, where *
and / have the same precedence, and are evaluated as encountered in
left-to-right order; + and – have lower precedence than * and /, and are also
evaluated in left-to-right order. Operator precedence and evaluation order can
be modified through use of parentheses, which can be nested. The following
are valid expressions:
(a) A + (B + C) * D
(b) (A + B) * 0.5
(c) MAU(P1,340NM) – MAU(P1,383NM)
(d) A/B * RATE(P1,P2,340NM,510NM)
The resulting value from a numerical expression is usually assigned to a
register or returned:
(e) RETURN A + (B + C) * D;
(f) C = (A + B) * 0.5;
(g) Z = MAU(P1,340NM) – MAU(P1,383NM);
(h) RETURN A/B
* RATE(P1,P2,340NM,510NM);
Note that assignment and return statements are always terminated by a
semicolon. Also, expressions may be broken into multiple lines to enhance
readability as in (h) above.
In addition to assignment (=) and being RETURNED, the value of a numerical
expression may be used in a comparison operation within a logical expression
(refer to Logical Expressions discussion below).
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Logical Expressions
Logical expressions are used within IF statements, which allow a statement or
group of statements to be executed when the logical expression evaluates to
TRUE.
Logical expressions are composed of comparison operations, combined
together using the AND and OR operators. (No NOT operator is provided, since
the comparison operations can be structured to effect the NOT operator).
Comparison operators include > (greater than) , < (less than), and two equal
signs == (equal to). Numerical expressions serve as operands for these
comparison operators. (Note that testing for equality is strongly discouraged,
since floating point calculations often experience rounding errors, which cause
equality comparisons to fail.)
Several AND and OR operators may appear within a logical expression. The
AND operator has higher precedence than the OR operator. The default
precedence and order of evaluation may be altered using parentheses. For
example:
(a) A>B
TRUE if register A is greater than register B.
(b) A > B AND C/D < 0.5
TRUE if register A exceeds register B, and C/D is less than 0.5.
(c) A > 100.0 OR B < 100.0 AND A/B > 0.50
TRUE if either of the two the conditions listed below tests TRUE:
(1) register A exceeds 100.0 or
(2) register B is less than 100.0 and the ratio of register A to
register B exceeds 0.50.
Note that in example (c) the AND operator has precedence over the OR
operator; the AND operation is tested first, despite the fact that it is the
rightmost operator.
The operators AND and OR are lower in precedence than the arithmetic *, /, –,
and + operators. Consequently, there is no need to use parentheses to
surround numerical expressions in comparison operations.
Functions
There are several functions that are useful for extracting data from the raw
photometer data arrays. In all cases, arguments must be supplied to the
function that tells the system which photometric reading(s) and which
wavelength(s) are of interest. Photometric readings are specified as P1, P2, P3,
or P4 and correspond to the readings specified on the User-Defined Method
screen. Wavelengths are specified as 293NM, 340NM, 383NM, 405NM,
452NM, 510NM, 540NM, 577NM, 600NM, or 700NM. In addition, the value
---NM is accepted as a null wavelength specifier, which indicates that no
wavelength is desired.
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RATE(Pw, Px, yyyNM, zzzNM) returns the rate of reaction (mAU/min) between photometric
readings Pw and Px for the bichromatic difference of
wavelength yyyNM minus wavelength zzzNM.
Note that there is no explicit monochromatic rate function. In order to obtain a monochromatic rate,
the null wavelength specifier should be used:
RATE(Pw, Px, yyyNM, ---NM) returns the monochromatic rate of reaction (mAU/min)
between photometric readings Pw and Px for the wavelength
yyyNM.
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The sample syringe can accommodate only 100 µL of total volume. You must
reduce either the sample or chase volume.
The system must be in STANDBY before attempting to STORE any changes.
Upon entry, or in response to pressing F4: Store, the system checks to be sure
no assays are in process. Since storing data may affect assays that are in
process, the system will not store new parameters until the system returns to
Standby.
The third reagent delivery must fall within the interval <60...920
seconds>.
In order to easily access the reagent delivery stations, reagent deliveries should
fall within this time interval. Deliveries are excluded between 257.3 and 389.3
seconds, since the cuvette cannot be accessed during this time. However,
there is opportunity for access during the interval 389.3 to 461.3 seconds,
which has an undesirable side effect of requiring the system to index cuvettes
until the cuvette enters an accessible zone. The system will accept a reagent
delivery during this interval, although it may sometimes result in wasted
cuvettes.
The third reagent delivery must follow the second by at least 30 seconds.
The reagent delivery system requires time to complete each delivery cycle. R2
and R3 reagent deliveries are precluded from being within 30 seconds of each
other.
The well aliquots total for each component must be the same (and
non-zero).
The number of aliquots for each reagent component identified must be the
same. It is not necessary that the number of aliquots for all components A, B,...
be the same in each well. However, the total of all the A component aliquots in
all A wells must equal the number of B aliquots in all B wells.
There are no current changes to undo. Do you wish to NULL the entire
record?
This message appears when F6: Undo Changes is pressed and there are no
current changes made to the channel. If the user enters Y, the channel is
initialized. Otherwise, the operation is aborted.
This password is not correct. You will not be permitted to STORE any
changes.
The user is prompted for the system password upon entry into User-Defined
Methods. If no password or an incorrect password is entered, this message is
presented to the user. If an invalid password is entered, anþattempt to store
using F4: Store will again result in a prompt for password, at which time
correct entry of the system password will permit data to be stored.
Undo current changes to this channel?
This message appears when F6: Undo Changes is pressed. If the user enters N,
the undo operation is aborted.
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Expiration: Refer to carton for expiration date of individual unopened reagent cartridges. Once
unwrapped, cartridges are stable for 30 days.
There are numerous distinct tests processed during a system check, each using
a different fluid delivery sub-system. For each test, the absorbance difference
between two wavelengths of Ponceau S diluted as sample or reagent are
measured by a two-filter (510, 600 nm) endpoint technique. The results of
these determinations must meet the specifications given in the specific
Operator’s Guide. If these conditions are not met, a system malfunction may
be indicated. Refer to the specific Operator’s Guide for troubleshooting
information.
Test Condition
Temperature 37º C
As part of daily maintenance, use the System Check procedure to process CHK
reagent. The routine will process 5 replicates of a variety of tests, which verify
that sampler and reagent fluidic performance is within specified limits.
Instruments with HM Systems are configured to run an automated system
check that does not require manual preparation of CHK fluid.
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Help Keys
The Help keys provide help on:
• a specific screen
• what tasks you can perform from that screen
• what the Function keys on that screen do
• some cases, a brief procedure for how to perform the tasks
The various help opportunities are listed below.
Alt/M Pressing the Alt and M keys simultaneously displays error messages
that are active. It does not display error messages that have been
viewed and reset.
Help The Quick Index. The Quick Index is a listing of specific tasks and
(From the Operating Menu) how to display the screens where help on performing that task is
available. The Quick Index includes the Function Key sequence to
display those screens from the Operating Menu.
Help Displays information on how to use the screen and the function keys
(From Any Other Screen) that are currently on the display.
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Reagent Temperature
Icon Description
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Cuvette Temperature
Icon Description
Icon Description
A red ON inside this icon indicates that power to the instrument has
just been interrupted and the UPS is in use. An intermittent alarm
also sounds, changing the word to LOW when the instrument is
preparing to shut down before the UPS loses all power. The UPS is
recharged when normal electric power is restored. If LOW appears
continuously while the instrument is connected to the wall outlet,
contact the Technical Solutions Center: Inside U.S.:
1-800-441-9250; Outside U.S. Refer to the local support team.
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Icon Description
The reaction vessel sensor, located near the top of the vessel feeder
chute, is not detecting a reaction vessel. Add reaction vessels to the
holder or check for a vessel jam in the vessel transfer system.
Icon Description
Reagent Manager
Icon Description
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Printer
Icon Description
Short Sample
Icon Description
One or more sample containers in the current Load List does not
have enough sample volume to run all its requested tests. Hold
down the Alt key and press L to view a list of these short samples.
See “Resolving a Short Sample Detected” on page 41 of Chapter 5:
Sample Processing and Test Results.
Check Needs
Icon Description
The yellow Needs Check icon appears when the system is checking
itself for any needs to process the Load List.
If the red Check Needs icon appears, the system has found needs
that require operator attention before samples can be processed.
Hold down the Alt key and press N to display the System Needs
screen to see which needs are required. To fill these system needs,
see “Responding to System Needs” on page 9 of Chapter 4: Setup
and Supplies.
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Alarm Status
Icon Description
The alarm has been turned off by the operator. If an error condition
occurs, the alarm will not sound; however, a message indicating the
reason for the alarm appears in the error message area.
Icon Description
Indicates that the Clot Check Error sample aborted error has
occurred. It shares the same location as the printer icon. If both a
printer icon and a clot check icon need to be displayed, the screen
will flash from one icon to the other.
Indicates that the Clot Check feature is turned off. It shares t he same
location as the printer icon. If both a printer icon and a clot check
icon needs to be displayed, the screen will flash from one icon to the
other.
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Keystroke Combinations
To use a keystroke combination, hold down the first key and press the second
key.
Control/Stop Stops all operations in progress in a manner that will not damage the
instrument. All tests in progress are aborted. However, all scheduled tests are
retained in instrument memory. To resume operations, press the Reset key.
Shift/Delete When entering information in a field, hold down the Shift key and press Delete
to delete all characters to the right of the cursor in a field.
Shift/Exit Moves you from the current screen directly to the Operating Menu.
Shift/--> When entering information in a field, hold down the Shift key and press the
right or left arrow key to move the cursor one space to the left or right. This
does not delete any information in the field.
Alt/L Takes you directly to the Load List – Short Samples screen. To display the All
and New Samples views, press F2: Next Status.
Alt/M Displays an explanation and troubleshooting information for the error message
that is on the screen.
Alt/P Prints out the entire screen appearing on the display. You cannot display any
other screen until this printing is complete. This does not affect instrument
processing.
Alt/R When the reagent manager icon appears in the Operating Conditions Status
area of the screen, press Alt/R to see information on why the icon appeared.
Alt/S Displays the Segment Status screen from which you can view the status of
either the segment positions currently loaded on the instrument (On Board
Segments view) or all segments (All Segments view).
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Operating Passwords
Operating Passwords are passwords that let you customize the instrument
operation to your work.
To start or stop using a password, display the System Configuration Menu
screen. Press F7: Password and type the password exactly as it appears below.
SHOWCL A chloride test is automatically requested when the Na/K test key is pressed. This
does not require additional sample.
ignoredup The software will not process samples on the instrument that have duplicate
barcode IDs.
However, there may be special situations where you must run a load list with
samples that have the same barcode ID.
You can do this using the special password “ignoredup” (short for “ignore
duplicates”). Any samples that have the same barcode ID will now be run.
DATA Turns on Method Diagnostic Data and allows you to print filter data for test
result troubleshooting with the Technical Solutions Center,
see Chapter 8: Alignments
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WARNING: Do not report a test result that appears on the printed report
with a message indicating that the result is
NON-REPORTABLE.
A test result line on the test report can display only one test report message. If
more than one test report message has affected the result, the instrument
prints the highest priority message. See “Test Report Message Priorities” on
page 26 of this Appendix.
WARNING: Do not report a test result that appears on the printed test
report with a reference range indicator if it also appears with
a test report message indicating that the result is
NON-REPORTABLE.
These reference range indicators appear next to a result according to the
ranges you have programmed for that method in the Method Parameters
screen. See “Entering Method Parameters” on page 45 of Chapter 10:
Customizing. Remember to follow laboratory procedures for lp and hp
indicators.
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HA1C
Explanation:
The Abnormal assay message indicates that the expected absorbance was not
met for a specific cuvette. A shift in absorbance may have occurred after
source lamp replacement or maintenance on/replacement of the cuvette
windows.
What to Do:
This result cannot be reported. If the Abnormal Assay message was obtained
after source lamp replacement or maintenance on/replacement of the cuvette
windows, it may be necessary to reset the HA1C Result Monitor baseline using
the Zero Data function key. Contact the Technical Solutions Center.
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Aborted Test
Explanation:
An action by either the operator or instrument aborted this test.
What to Do:
Rerun the test.
Absorbance
Explanation:
The MAU at the measurement wavelength exceeded 2000.
What to Do:
Rerun the sample. If the error occurs on the rerun, it may be due to optical
interference.
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Arithmetic
Explanation:
This error is associated with nonlinear (logit) methods only. This error occurred
in result calculations because the change in absorbance was less than the C0
or greater than C0 + C1.
What to Do:
If on a patient sample, the concentration is either very high or very low. Rerun
the sample or contact the Technical Solutions Center: Inside U.S.:
1-800-441-9250; Outside U.S. Refer to the local support team. If QC has also
shifted low, change the R2 reagent pump 2500 µL syringe, cancel the well in
use and prepare new reagent.
Assay Range
Explanation:
The result is above or below the method assay range listed in Method
Parameters on the instrument. Can be either low or high.
What to Do:
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If the result is LOW, analyte values may be depressed below the assay range
because the patient sample has very little or no concentration of the analyte,
insufficient sample, is falsely depressed because of interfering substances, or
there was an instrument system failure. Each laboratory should establish its
own protocol for addressing the "Below Assay" test report message before
reporting the result as less than the established clinical reportable range. The
procedure should check:
• The sample container has sufficient usable sample for the tests ordered.
• The sample container was placed in the appropriate segment and cup
position.
• Verify instrument function.
If no obvious reason for the low analyte result is found, or the result is
inconsistent with the available clinical information and prior tests, you can
confirm the accuracy of the result with additional testing such as:
• If the result is a negative number, perform a 50% recovery of a known
standard or QC material to confirm that there was no activity in the sample,
that there was enough sample volume used by the instrument, and that
there was no system malfunction. See “50% Recovery of a Known Standard
Using a Sample” on page 24 of this Appendix.
• If the result is below the reportable assay range, prepare and run a mixture
of the sample with a known standard or QC material to confirm that there
was low activity in the sample below the assay range, that there was
enough sample volume used by the instrument, and that there was no
system malfunction. See “50% Recovery of a Known Standard Using a
Sample” on page 24 of this Appendix.
If the result is HIGH, check the method IFU to determine if the sample can be
diluted. If yes, manually dilute the sample (see IFU for recommended diluent)
and rerun the test. Make the smallest dilution possible to bring the result down
into the assay range. Enter the dilution factor as a whole number on the Enter
Sample Data screen and the instrument will multiply the result by this factor.
See “Dilution of a Sample” on page 23 in this Appendix.
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ClotCheck Err
Explanation:
A test result with a "ClotCheck Err" test report message will not include a
numerical result. Any successfully completed test results from the same
sample cup will be displayed. Any tests that have not yet aspirated sample
from the same sample cup will be aborted and will have an "Aborted Test"
message associated with them.
What to Do:
For all clot check errors follow the Alt/M troubleshooting steps in the
Dimension EXL ™ software or refer to See “Resolving Clot Check Errors” on
page 45 of Chapter 5: Sample Processing and Test Results.
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Diluted.
Explanation:
The test has been autodiluted.
What to Do:
If test result is printed, the result (which exceeds the assay range) may be
reported.
If no test result is printed, the result did not exceed the assay range. Do the
following:
• Ensure that sufficient sample volume was available in the sample
container.
• Verify the sample quality (fibrin, air bubbles, etc.).
• Rerun the test.
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If a TBIL and a DBIL are ordered together and the TBIL result contains a
non-reportable test report message or error condition, the DBIL test will be
aborted.
What to Do:
If only a TBIL was ordered, report the TBIL result.
If both TBIL and DBIL were ordered, together or separately, report the TBIL
result. Follow your laboratory’s procedures for reporting DBIL results when the
sample is hemolyzed.
WARNING: Do not report a DBIL result while the TBIL for the sample is
still running because the hemoglobin error can appear only
after the TBIL result is complete.
HI
Explanation:
Result is higher than the reference interval.
What to Do:
Result may be reported.
11 - 20 2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Appendix
What to Do:
If your system is set up to perform automatic dilutions, refer to “Automatic
Dilutions” in the Customizing section for possible reasons why autodilution
was not performed.
HIL Interf
Explanation:
One or more of the HIL indexes for the method is equal to or greater than the
HIL Alert Index entered during HIL Setup.
What to Do:
Follow your laboratory’s procedures for reporting results when the sample is
hemolyzed, icteric, and/or lipemic.
hp
Explanation:
Result is higher than the panic interval.
What to Do:
Follow your laboratory’s procedure for panic values that are out of range.
LO
Explanation:
Result is lower than the reference interval.
What to Do:
Result may be reported.
2011/09 11 - 21
Appendix Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
lp
Explanation:
Result is lower than the panic interval.
What to Do:
Follow your laboratory’s procedure for panic values that are out of range.
Measurement
Explanation:
During photometric measurement, the system detected an insignificant
software timing error.
What to Do:
Rerun sample.
• If this error recurs for a photometric method, a problem may exist in the
instrument measurement system. Call the Technical Solutions Center.
• If this error recurs for an IMT method, troubleshoot the IMT error message.
No Reagent
Explanation:
There is no reagent cartridge on the reagent tray for this method.
What to Do:
Load a new reagent cartridge into the instrument. If you had previously loaded
a reagent cartridge but did not obtain any results, check for and troubleshoot
any reagent preparation errors listed on the Error Log screen.
Process Error
Explanation:
An error occurred that prevented the system from determining the result.
What to Do:
If this error message appears in the message field on the screen, press Alt/M
and follow the steps that appear. If it does not appear in the message field, go
to the Error Log screen. Move the cursor to the error, press F5: More Info, and
follow the steps to resolve it. To navigate to the Error Log screen from the
Operating Menu, press F5: Process Ctrl > F6: Error Log.
11 - 22 2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Appendix
Temperature
Explanation:
This message appears when one of the following modules is outside of
temperature range: cuvette, HM incubation wheel, LOCI® reader module.
What to Do:
Check the operating conditions status area for a temperature icon.
If a cuvette temperature icon is present in the status area, calibrate the cuvette
system temperature. If an HM temperature icon is present in the status area,
calibrate the HM temperature. If a LOCI® temperature icon is present, call the
Technical Solutions Center.
Dilution Examples
This section contains three examples of dilutions and how they are used to
resolve samples with test report messages.
Dilution of a Sample
When a test result exceeds the assay range for a method, the Dimension® EXL™
instrument will automatically dilute the sample (based on the AutoDilute Vols
field on the Method Parameters screen) and rerun the test.
If the test result still exceeds the assay range the printed test report will
contain the message “assy rng/dilu” indicating that the instrument diluted the
sample and the result is still above the assay range for the method.
You will now need to make a manual dilution of the sample and rerun it. If the
sample can be diluted, make the smallest dilution possible to bring the result
down into the assay range. Make a dilution slightly greater than what was
done by the instrument.
To run this diluted sample, enter the number 5 in the Dilution field on the
Enter Sample Data screen and the instrument will multiply the result by this
factor for you.
2011/09 11 - 23
Appendix Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
For Example:, the “assy rng/dilu” test report message was printed next to the
GLU method on the printed test report. According to the volume programmed
in the Method Parameters screen for the GLU method, the instrument made a
1:1.5 dilution. According to the Method IFU, water can be used to dilute the
sample.
11 - 24 2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Appendix
Prepare a 1:2 dilution of a known standard using the formulas below. If the
ALC test result for this mixture matches the concentration of ALC in the known
standard, then a “0” may be reported for the original sample.
To run this mixture, enter the number 2 in the Dilution field on the Enter
Sample Data screen and the instrument will multiply the result by this factor
for you.
2011/09 11 - 25
Appendix Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
11 - 26 2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Appendix
Mains supply 115 ±10% VAC or 230 ±10% VAC, 50/60 Hz, 100+/-10% VAC
Pollution Degree Degree 2, normal indoor laboratory environment. Air contains only
non-conductive pollutants with occasional condensation.
Barcode Scanner
The barcode scanner uses Class I LEDs (light-emitting diodes), and is not
hazardous to your eyes.
WARNING: The Dimension® EXL ™ system should not be used next to any
Industrial Scientific and Medical (ISM) equipment that must
functionally produce RF energy (e.g., Diathermy Equipment).
2011/09 11 - 27
Appendix Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Instrument Labels
HM Wash Diagram
11 - 28 2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Appendix
2011/09 11 - 29
Appendix Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
11 - 30 2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Appendix
2011/09 11 - 31
Appendix Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
11 - 32 2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Index
A
About this Guide 1-1
How this Guide is Organized 1-4
About this guide
Using this Guide 1-3
Air Filters
Replacing 7-12
Alert Keys 10-75
Configuration Calibration Alerts 10-78
Configuring QC Alerts 10-78
Configuring STAT Status 10-75
Configuring the Supplies Alert 10-77
Alignments 8-1
Barcode Scanner 8-4
Cuvette Ring 8-6
General Information 8-2
HM Module 8-8
LOCI® Arm 8-16
Offsets 8-2
Printing and Viewing 8-3
Photometer 8-19
R1 Reagent Probe 8-20
R2 Reagent Probe Alignments 8-25
Reagent Tray Alignment 8-31
Sample Probe 8-34
Appendix 11-1
Calibration (Verification) Review Flow Chart 11-4
Calibration (Verification)Setup Flow Chart 11-3
General Code Compliance Information 11-27
Help Keys 11-5
Instrument Labels 11-28
Keystroke Combinations 11-11
Operating Conditions Status Area Icons 11-6
Operating Passwords 11-12
Test Report Messages and Reference Range Indicators 11-13
2011/09 12 - 1
Index Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
C
Calculated Results 10-17
Calibration 6-2
Alerts 10-78
Calibration Alert 6-4
Configuration
Definine Calibration Auto Acceptance Parameters 10-23
Definine Calibration Product 10-21
Edit Calibration Product 10-21
Entering Data Manually 10-21
Scanning Barcode Data 10-21
Cuvette System Temperature 7-26
Group 6-6
Alerts 6-6
HA1C 6-3
HB1C 6-3
HM Temperature 7-30
IMT 6-19
Electrolyte Coefficients 6-20
IMT System 6-2
Overview 6-2
Photometric and LOCI® Methods 6-3, 6-7
Cancelling Calibration 6-9
Reviewing and Accepting Results 6-8
Setting Up and Running a Calibration 6-7
Viewing History 6-10
Reagent System Temperature 7-28
Review Flow Chart 11-4
Setup Flow Chart 11-3
Troubleshooting 6-11
Calibration Statistics 6-11
Precision of Calibration Results 6-11
Quality Control 6-12
Urine Drugs of Abuse Methods 6-3
User-Defined Methods 10-112
Using Status Lists 6-21
Create a List of Methods 6-21
Create a Reminder List for Expiring Calibrations 6-22
Removing Calibrations from Instrument Memory 6-23
Verifying Photometric Methods 6-13
Calibration and Quality Control 6-1
Calibrating Photometric and LOCI® Methods 6-7
Calibrating the IMT System 6-19
Calibration Troubleshooting 6-11
Calibration/Verification Overview 6-2
Group Calibration Alerts/Run Calibration Group 6-6
12 - 2 2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Index
2011/09 12 - 3
Index Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
D
Daily Setup 4-2
Checking for Other Maintenance 4-3
Cleaning the Sample Area and Emptying Cuvette Waste 4-2
Managing Offboard Reagent Lots 4-7
Overview 4-2
Recording Daily Maintenance Results 4-4
Running a System Check 4-4
Understanding the System Counters Screen 4-7
Decontamination 7-148
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Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Index
E
Entering and Running Batch Samples 5-14
Entering Sample Data 5-11
Entering Sample Data Screen Fields 5-12
Error Messages 9-14, 10-123
Active System Errors Screen 9-14
Error Log Screen 9-15
Software Error Troubleshooting Help 9-16
User-Defined List 10-123
F
Flex®
Cartridge Configuration 10-106
Cartridge Configuration Fields 10-107
Filling a Cartridge 10-110
Loader Home Sensor 7-50
Loading Cartridge 10-111
Presence Sensor Board 7-51
Fuses 7-52
Replacing AC 7-52
Replacing DC 7-54
G
General Instrument Care and Cleaning 7-2
Clearing Jams 7-2
Materials for Cleaning 7-4
Opening the LOCI® Access Lid 7-3
Opening the Reagent Lid 7-2
Removing the HM Incubation Wheel Cover 7-3
H
Heat Torch Assembly 7-54
Help Keys 9-3, 11-5
HIL 10-71
Alert Index Values 10-72
Setup 10-73
Histogram Plot 10-57
Printing Information 10-58
HM Consumables 4-17
Replacing HM Fluids 4-17
HM Incubate Wheel 7-57
HM Incubation Wheel Cover 7-3
HM Module
Alignments 8-8
HM Pump 7-62
HM Pump Heads
Replacing 7-18
HM Shuttle Home Sensor 7-65
HM Vessel Detect Switch 7-66
HM Wash
Diagram 11-28
HM Wash Probe 7-67, 7-70
Tubing 7-72
2011/09 12 - 5
Index Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
I
IMT
Cleaning the System 7-11
Configuration 10-43
Bleach/Condition Soak Interval 10-44
ECO2 Test Method 10-43
Miscellaneous Tubing 7-74
Pump Tubing 7-9
Rotary Valve Seal 7-79
Rotary Valve Sensor 7-82
Rotary Valve Tubing 7-84
Tubing Diagram 7-76, 11-29
Waste Tubing 7-36
IMT Consumables 4-21
Replacing IMT Fluids 4-21
Replacing the QuikLYTE® Integrated Multisensor 4-22
Resolving a Failed Dilution Check 4-25
Running a Dilution Check 4-24
IMT Troubleshooting 9-17
Error Message 9-17
IMT Results 9-17
IMT Tubing 7-76
Installation Specifications 2-11, 2-13
Additional Requirements 2-16
Host Interfacing 2-16
Phone Line 2-16
External Uninterruptible Power Source 2-16
Power Requirements 2-14
Instrument Power Specifications 2-14
Leakage Current 2-14
Printer Shelf 2-16
Room Temperature Requirements 2-15
Space Requirements For Dimension® EXL ™ 200 System 2-13
Dimensions 2-13
Minimum Clearances 2-13
Weight 2-13
Space Requirements For Dimension® EXL ™ with LM System 2-11
Dimensions 2-11
Minimum Clearances 2-11
Weight 2-11
Water Requirements 2-15
Instrument Labels 11-28
Cuvette Film Diagram 11-31
HM Wash Diagram 11-28
IMT Tubing Diagram 11-29
Pump Panel Tubing Diagram 11-30
Instrument Options 10-3
Select/Change 10-3
System Configuration Menu Function Keys 10-5
12 - 6 2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Index
L
Laboratory Data 10-93
Understanding Data Fields 10-94
Levey-Jennings Plot 10-59
Patient Results 10-59
Printing L-J Patient Information 10-59
Printing L-J QC Information 10-60
QC Results Plot 10-60
Load Errors 5-39
Load List Errors 5-40
Loading Samples 5-16
LOCI®
Arm Alignment 8-16
Arm to Detector Alignments 8-17
Arm to Vessel Alignments 8-16
Insert 7-86
Vacuum Cup 7-87
M
Maintenance 7-1
General Instrument Care and Cleaning 7-2
Monthly Maintenance 7-8
Other Maintenance 7-22
Weekly Maintenance 7-5
Major Components of the Dimension® EXL ™ system
Major Components of the HM Area 3-9
Major Components of the IMT Area 3-8
Major Components of the LOCI® Module 3-13
Major Components of the Printer Area 3-12
Major Components of the Reagent Area 3-10
Major Components of the Thermal Chamber Area 3-11
Materials for Cleaning 7-4
Bleach Solutions 7-4
Sodium Hydroxide Solutions 7-4
Undiluted Bleach 7-4
Method Kinetics 10-113
Screen 10-113
Screen Fields 10-114
Using 10-117
Method Parameters 10-45
Automatic Dilutions 10-48
Autodilute 10-48
Automated Urine Dilutions 10-48
User-Defined Methods 10-110
Method Review 10-55
Histogram Plot 10-57
Levey-Jennings Plot Views 10-59
Method Review Screen Fields 10-62
Method Review Screen Function Keys 10-64
Results Listing View 10-56
2011/09 12 - 7
Index Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
O
Offboard Reagent Lots 4-7
Operating Passwords 11-12
Optical Filters 7-87
Other Maintenance 7-22
Accessory Spare Parts Kit 7-22
Calibrating Cuvette System Temperature 7-26
Calibrating HM Temperature 7-30
Calibrating Reagent System Temperature 7-28
Checking 4-3
Cleaning Cuvette Windows 7-31
Cleaning the IMT Waste Tubing 7-36
Cleaning the Sample Probe and Drain 7-38
Cleaning the Water Bottle 7-39
Clot Check Bypass 7-22
Decontamination 7-148
Lowering and Raising the Thermal Chamber 7-24
Replace Sample Tubing (Clot Check Configured) 7-129
Replacing a Pump Limit Sensor 7-94
Replacing a Pump Solenoid Valve 7-98
Replacing a Pump Syringe 7-101
Replacing a Reagent Arm Radial Home Sensor 7-105
Replacing a Reagent Arm Vertical Home Sensor 7-106
Replacing a Reagent Probe Tip 7-110
Replacing an HM Pump and Motor Assembly 7-62
Replacing an HM Wash Probe 7-67
Replacing Clot Check Transducer Board 7-131
Replacing Fuses 7-52
Replacing HM Wash Probe Tubing 7-72
Replacing HM Wash Wheel 7-73
Replacing IMT Miscellaneous Tubing 7-74
Replacing Printer Paper 7-93
Replacing Sample Tubing 7-127
Replacing the Cuvette Diaphragm 7-39
Replacing the Cuvette Film Cartridge 7-42
Replacing the Cuvette Formation Spring Tip and E-Clip 7-45
Replacing the Cuvette Ring Sensor 7-49
Replacing the Flex® Loader Home Sensor 7-50
Replacing the Flex® Presence Sensor Board 7-51
Replacing the Heat Torch Assembly 7-54
Replacing the HM Incubate Wheel or Wash Wheel Home Sensor 7-57
Replacing the HM Mixer Assembly PC Board 7-60
Replacing the HM Shuttle Home Sensor 7-65
12 - 8 2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Index
P
Panel Keys 10-70
Pediatric Tubes
Using 5-7
Performing Power Shutdowns and Startups 2-7
Important Power Safety Information 2-7
Performing a Controlled Power Shutdown 2-7
Performing an Emergency Shutdown 2-8
Restoring Power After a Controlled Shutdown 2-8
Restoring Power After an Emergency Shutdown 2-10
Types of Shutdowns 2-7
Controlled 2-7
Emergency 2-7
Photometer
Alignment 8-19
Filter Wheel Dual Sensor 7-90
Home Sensor 7-92
Photometric Methods
Verification
Cancelling 6-16
Reviewing and Accepting Results 6-15
Setting Up and Running 6-13
Preparing Samples 5-2
Checking for Adequate Sample Volume 5-9
Placing Barcode Labels on Sample Tubes 5-8
Sample Preparation 5-2
Types of Containers 5-2
Using Pediatric Tubes 5-7
2011/09 12 - 9
Index Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Q
QC
Alerts 10-78
Reviewing Results 10-68
User-Defined Methods 10-112
Quality Control 6-24
Crossover QC 6-26
Daily QC 6-25
Defining QC Panels 6-31
Defining QC Products 6-29
Editing QC Panels 6-32
Editing QC Products 6-30
Entering Ranges 6-28
Grouping Alerts 6-33
New Reagent and Control Lots 6-25
Previously Defined QC Product 6-31
Processing Samples 6-26
Program 6-24
QC Materials 6-25
Review 6-25
Setting Expiration Period and Checking Status 6-28
Urine Drugs of Abuse Methods 6-26
Using Alert Key 6-27
R
R1 Reagent Arm
Delivery 10-103
Drain Alignment 8-21
Reagent Tray Alignment 8-24
Target Cuvette Alignment 8-22
R1 Reagent Probe 8-20
R2 Reagent Arm
Drain Alignment 8-26
HM Incubate Wheel Alignment 8-30
Probe Alignments 8-25
Reagent Arm Rotational Home Sensor 7-108
12 - 10 2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Index
S
Safety and Specifications 2-1
Safety 2-2
Biohazard and Probe Safety 2-2
Instrument Removal 2-2
General Safety 2-2
Safety Labels 2-3
Safety Notes 2-2
Symbols Key 2-6
Sample
Delivery 10-103
Sample ID 10-88
Sample Probe
Alignments 8-34
Cup 8-36
Cuvette 8-35
Drain 8-37
HM Incubate Wheel 8-38
2011/09 12 - 11
Index Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
12 - 12 2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Index
Reset 3-16
Run 3-16
Stop 3-16
Cursor Movement Keys 3-18
Keyboard Keys 3-18
3-18
Alt 3-18
Backspace 3-18
Enter 3-18
Tab 3-18
Keypad Keys 3-17
Alarm Off 3-17
Delete 3-17
Enter 3-17
Exit 3-17
Help 3-17
Numbers 3-17
PgDn 3-17
PgUp 3-17
Test Keys 3-14
Keyboard Overlays 3-15
Using the Touchscreen 3-19
Additional Touchscreen Keys 3-24
Alert Keys 3-24
Applications Area 3-23
Error Message Area 3-22
Function Keys Area 3-23
Instrument Status Area 3-19
Date and Time Box 3-21
IMT System Status Box 3-21
Photometric Sampler Status Box 3-20
Processing Status Box 3-20
Message Area 3-23
Operating Conditions Status Area Icons 3-21
Segment Status Area 3-22
Status Area Icons 11-6
Alarm Status 11-10
Check Needs 11-9
Clot Check Status 11-10
Cuvette Film Cartridge 11-8
Cuvette Temperature 11-7
Printer 11-9
Reagent Manager 11-8
Reagent Temperature 11-6
Short Sample 11-9
UPS 11-7
Store Laboratory Data 10-93
System Check
Running 7-145
System Check Troubleshooting
9-9
Resolving Miscellaneous System Check Error Conditions 9-9
Unacceptable LOCI® Ranges 9-13
Unacceptable Mean or SD for a Reagent Arm 9-10
2011/09 12 - 13
Index Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
T
Test Counters 10-92
Test Keys 10-98
Assignments 10-98
Programming 10-100
Test Report 5-33
Messages 11-14
Abnormal Assay 11-14
Abnormal Reaction 11-15
Aborted Test 11-15
Above Assay Range 11-16
Absorbance 11-15
Antigen Excess 11-16
Aritmetic 11-16
Assay Range 11-16
Assay Range Diluted 11-17
Below Assay Range 11-18
12 - 14 2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Index
2011/09 12 - 15
Index Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
U
Understanding the System Counters Screen 4-7
Dimension® EXL ™ System Counters Screen 4-7
HM System Counters Screen 4-7
UPS (Uninterruptible Power Source) 11-7
U-Seal Element 7-138
User-Defined Methods 10-101
Calibration and QC 10-112
Customer Responsibility 10-102
Defining Flex® Cartridge Configuration 10-106
Defining Photometry Reading Times 10-105
Allowable Time Ranges 10-105
Defining Reagent and Sample Deliveries 10-103
Reagent and Sample Delivery Fields 10-104
Reagent Deliveries R2 and R3 10-104
Reagent Delivery R1 10-103
Sample Delivery 10-103
Defining the Calculation 10-108
Writing 10-108
Entering Method Parameters 10-110
Error Messages List 10-123
Filling a Flex® Cartridge 10-110
Flex® Cartridge Configuration Fields 10-107
Identifying the Method 10-102
Loading the Flex® Cartridge 10-111
Predefined Calculation Template 10-108
Fields 10-109
Programming Structure 10-118
Expressions 10-121
Functions 10-122
IF ELSE Statement 10-121
Implementation 10-118
Logical Expressions 10-122
Numerical Expressions 10-121
Statements 10-119
Programming Terms 10-118
Reviewing Method Kinetics 10-113
Running 10-112
Storing a Method 10-110
Warranty 10-102
Worksheet 10-127
Using this Guide
College of American Pathologists 1-3
For Additional Help 1-3
V
Vacuum Pump Muffler Filter 7-141
Verifcation Troubleshooting 6-17
Precision of Results 6-17
Quality Control 6-18
Statistics 6-17
12 - 16 2011/09
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Index
W
Wash Wheel Home Sensor 7-57
Water Bottle 7-39, 7-142
Weekly Maintenance 7-5
Cleaning HM Wash Probes and the R2 Reagent Probe 7-5
2011/09 12 - 17
Index Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
12 - 18 2011/09