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CellaVision, CellaVision DM9600/DM1200

CellaVision, CellaVision DM9600/DM1200

Hematology analyzers, November 2017

Contact Information

CellaVision
Ken Childs
ken.childs@cellavision.com
2530 Meridian Parkway, Suite 300
Durham, NC 27713
919-806-4420


Name of instrument CellaVision DM9600/DM1200
First year installed in U.S./Outside U.S./No. of units sold in 2016 2004/2003/—
No. units installed in U.S./Outside U.S./List price —/—/~$135,000–$175,000
Test menu: • Chartable (standard menu: WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso) neut %&#, mono, lymph, eos, baso, segmented, bands, blast, promyelocytes, myelocytes, metamyelocytes, variant lymphocytes, plasma cells, giant platelets, platelet clumps, erythroblasts; RBC morphology pre-characterizations include anisocytosis, poikilocytosis, polychromasia, microcytosis, macrocytosis, hypochromia
• Laboratory
• Flags
FDA-cleared tests not clinically released
Tests not available but submitted for 510(k) clearance
Tests in development
Tests for research use only
Tests unique to analyzer analysis of cytocentrifuged samples, body fluids (reported parameters: neutrophils, eosinophils, lymphocytes, macrophages, including monocytes), other (basophils, lymphoma cells, atypical lymphocytes, blast cells, and tumor cells)
Differential method(s) used light microscopy, image analysis, and artificial neural networks
Analytical measurement range:
• WBC count/RBC count
• Hemoglobin/Platelet
• MCV (fL) or Hct (%)
•Reticulocytes
Precision:
• WBC count/RBC count
• Hemoglobin/Platelet
• MCV or Hct
Accuracy of automated differential compared with manual differential (per CLSI H20-A2) seg neut% y=0.97x+1.3, r= 0.987; lymph% y=0.97x + 1.2, r= 0.979; eos% y=1.01+0.1, r=0.960; mono% y=0.97+0.2, r=0.941; band neut% y=0.87x+0.1, r=0.917
Interfering substances:
• WBC
• RBC
• MCV or Hct
• Platelet
• Hemoglobin
Interfering substances: differential
Maximum CBCs per hour/Maximum CBCs and differentials per hour —/35 differentials
Minimum specimen volume open/Closed/Sample dead volume closed
Microsample capability
Prepares microscope slides automatically or flags problems for slide prep
Number of automatic slidemakers available/List price
Archives patient data/Previous patient results incl. with recent results yes/no
Maximum archived data accessible when system online unlimited
No. specimens for which numeric results saved in memory at once ~4,000
No. specimens for which histo/cytogram results saved in memory at once
Performs delta checks no
Tags and holds results for follow-up, confirmatory testing, or rerun
Parameters for flags for holding samples defined by user or vendor
Scattergram display: cell-specific color
Histogram display: color with thresholds
User interface can display choice of specimen or result information
LIS interface formats supported ASTM 1394
Information transferred on LIS interface numeric and flag results, instrument to LIS; patient demographics, orders, LIS to instrument—broadcast; host query for patient demographics and orders
LOINC codes transmitted with all results no
Sent in message to LIS no
Listing of machine codes and corresponding LOINC for each test yes (for peripheral blood)
Interface available or planned to automated specimen-handling system
Barcode symbologies read on specimen tube Codabar, codes 39 and 128, Interleaved 2 of 5, QR, DataMatrix
Accommodates barcode placement per CLSI standard AUTO02-A2
No. of cleaning or maintenance reagents/No. of routine liquid reagents none/1
Time required for daily, weekly, monthly maintenance daily: none; weekly: 5 minutes
Onboard diagnostics for troubleshooting/Limited to software problems yes/no
Manufacturer can perform diagnostics via modem no
Distinguishing features (supplied by company) fully automated slide handling and oiling available in two models for medium and large laboratories; performs peripheral blood and body fluid differentials; WBC and other nucleated cells classified into 18 different categories; RBC morphology characterized for six categories; network use allows remote review of blood smears and linking of multiple analyzers in multiple locations
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
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