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Beckman Coulter, DxH Connected Workcell


Beckman Coulter, DxH Connected Workcell

Hematology analyzers, November 2017

Contact Information


Beckman Coulter

Matthew Rhyner
mnrhyner@beckman.com
11800 SW 147th Ave.
Miami, FL 33196
305-380-3800


Name of instrument DxH Connected Workcell
First year installed in U.S./Outside U.S./No. of units sold in 2016 2014/2014/—
No. units installed in U.S./Outside U.S./List price 100/200/$690,000
Test menu: • Chartable (standard menu: WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso) standard menu (left) plus: IRF, MPV, MRV, NRBC %&#, RDW-CV, RDW-SD, automated retic #, retic %; body fluids: total nucleated count and RBC count for synovial, serous, CSF fluids and slidemaking
• Laboratory
• Flags suspect, system, and exception messages for samples requiring review
FDA-cleared tests not clinically released
Tests not available but submitted for 510(k) clearance
Tests in development
Tests for research use only body fluid mononuclear %&#, body fluid polymorphonuclear %&#, early granulated cells %&#, high light scatter reticulocytes %&#, low hemoglobin density, microcytic anemia factor, mean sphered cell volume, plateletcrit, platelet distribution width, reticulocyte distribution width, more
Tests unique to analyzer
Differential method(s) used Automated Intelligent Morphology using volume, conductivity, and five angles of light scatter, digital signal processing, advanced algorithm applications, high-definition cellular resolution, DataFusion
Analytical measurement range:
• WBC count/RBC count 0.050–400.000/0.005–8.500
• Hemoglobin/Platelet 0.10–25.50/3.0–3,000.0
• MCV (fL) or Hct (%) 0.00–85.00 (Hct) for operating range, 50.00–150.00 (MCV) for measuring range
•Reticulocytes 0.000–30.000
Precision:
• WBC count/RBC count ≤3.0%/≤1.5%
• Hemoglobin/Platelet ≤1.5%/≤3.5%
• MCV or Hct ≤1.0% (MCV)
Accuracy of automated differential compared with manual differential (per CLSI H20-A2) neut= ±2.0; lymph, mono= ±3.0; eso, baso= ±1.0 (or 10%, whichever is greater)
Interfering substances:
• WBC precipitated elevated proteins, cryoglobulin, fragmented white cells, agglutinated white cells, lyse-resistant red cells, giant platelets, platelet clumps, unlysed particles >35 fL in size
• RBC very high WBC count, high concentration of very large platelets, autoagglutinins
• MCV or Hct very high WBC count, high concentration of very large platelets, autoagglutinins
• Platelet platelet clumps, white cell fragments, very small red cells, red cell fragments, giant platelets, electronic noise
• Hemoglobin severe lipemia, heparin, certain unusual RBC abnormalities that resist lysing
Interfering substances: differential elevated triglycerides, precipitated elevated proteins, hypogranular granulocytes, agranular granulocytes, lyse-resistant red cells, very small or multipopulation lymphocytes
Maximum CBCs per hour/Maximum CBCs and differentials per hour up to 300/up to 300
Minimum specimen volume open/Closed/Sample dead volume closed 165 µL/165 µL/300–400 µL
Microsample capability yes
Prepares microscope slides automatically or flags problems for slide prep yes
Number of automatic slidemakers available/List price —/DxH SMS $165,000
Archives patient data/Previous patient results incl. with recent results —/no
Maximum archived data accessible when system online 90,000 standalone
No. specimens for which numeric results saved in memory at once 90,000 standalone
No. specimens for which histo/cytogram results saved in memory at once 90,000
Performs delta checks yes
Tags and holds results for follow-up, confirmatory testing, or rerun yes
Parameters for flags for holding samples defined by user or vendor yes
Scattergram display: cell-specific color yes
Histogram display: color with thresholds yes
User interface can display choice of specimen or result information yes
LIS interface formats supported CLSI LIS01-A2
Information transferred on LIS interface numeric and flag results, histograms and scatterplots, instrument to LIS; patient demographics, orders, LIS to instrument—broadcast; host query for patient demographics and orders (available with release of workcell)
LOINC codes transmitted with all results no
Sent in message to LIS no
Listing of machine codes and corresponding LOINC for each test no
Interface available or planned to automated specimen-handling system Beckman Coulter
Barcode symbologies read on specimen tube Codabar, codes 39 and 128, Interleaved 2 of 5, NW7
Accommodates barcode placement per CLSI standard AUTO02-A2 yes
No. of cleaning or maintenance reagents/No. of routine liquid reagents 7/9
Time required for daily, weekly, monthly maintenance automated shutdown programmable with <1 minute user time daily
Onboard diagnostics for troubleshooting/Limited to software problems yes/no
Manufacturer can perform diagnostics via modem yes
Distinguishing features (supplied by company) DxH Workcell automation solutions reduce turnaround time without the need for track-based automation; Automated Intelligent Morphology (AIM) provides three independent counts for RBC, WBC, PLT; blast flagging by cell lineage; reliable MVP with few interferences and reliable hemoglobin with few interferences
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