Product specification Measurement principles

• Product specification • Measurement principles • Conclusion

• Product specification • Measurement principles • Conclusion • • • External view General specification Reagents Sampling mode Control blood MTBF Customer maintenance Performances Directives and standards

External view Compact bench top system 42 cm Size: 14 x 12. 6 x 16. 5 in Weight: 14 kg / 30 lb 36 cm 32 cm

General specifications 8 parameters / 2 histograms WBC, RBC, Hgb, Hct, MCV, MCHC, Plt 18 parameters / 3 histograms WBC, RBC, Hgb, Hct, MCV, MCHC, Plt, RDW, MPV, Pct, PDW Lym, Mon, Gra (% & #)

Reagent pack or bottles Intuitive software Optional smart card reader Minipack or bottles

Onboard reagents 3 reagents • ABX Diluent • ABX Alphalyse or Lysebio • ABX Cleaner 2 options • Minipack • Bottles Minipack containing waste and reagents

Open or close tube 2 sampling modes Closed tube Throughput OT: 60 samples per hour CT: 55 samples per hour Open tube

Sampling tubes Up to 13 alphanumeric characters External bar-code reader Sampling holder

Sampling volume ABX patented the MDSS concept: Whole blood micro-sampling 10 µl Minimum sample volume in tube 50 µl No sampling valve No maintenance No clogging

Controls and calibrator Controls • ABX Minotrol 8 (Low, Normal, High) • ABX Minotrol 16 (Low, Normal, High) Calibrator • ABX Minocal Multi-language package insert CE marking

Environmental protection Fluids Liquid waste Solid waste 19 ml / sample 0, 31 g / sample Power Requirements Power supply Power consumption From 100 Vac to 240 Vac (50 HZ to 60 Hz) Maximum 150 VA Total number of active days for all active equipment MTBF = -------------------------------- = around 600 days Number of interventions for breakdown

Customer maintenance Automatic shut-down Stepper motors replace the old compressor concept -> No noise, no maintenance A double needle replace the old shear valve concept -> Small sampling volume without maintenance Liquid valve replace the old pinch valve concept -> No clogging, no maintenance

Directive and standards Directives 98/79/EC - IVD medical devices 89/336/EEC-EMC 72/23/EEC - Low voltage Standards IEC 1010 -1: 1990 + A 1: 1992 + A 2: 1995 EN 61326: 1997 + A 1 EN 61000 -3 -2: 1995 + A 1 + A 2: 1998 + A 14: 2000 EN 61000 -3 -3: 1995 CSA - C 22 - 2 No. 1010. 1 -92 UL 3101 -01: 1993

• Product specification • Measurement principle • Conclusion • • • RBC / PLT WBC HGB Flags and alarms Data management

Method & technologies RBC/PLT/WBC - Impedance method HGB - Spectro-photometry HCT - Measured MCV, MCHC - Calculated

RBC / PLT count Impedance method Behind the aperture, a Diluent flow avoids the re-circulation of cells. RBC/PLT mobile threshold

RBC / PLT count - Methods & technologies: RBC/PLT distribution RBC: Distribution curves on 256 counting channels from 30 fl to 300 fl. PLT: Distribution curves on 128 channels from 2 fl to a mobile threshold. This threshold moves according to the microcyte population present in the analysis area.

WBC count - Methods & technologies: WBC and differential measuring principles Histograms Distribution curves on 256 counting channels from 30 fl to 450 fl. Lymphocytes (30 f. L to 100 f. L) Monocytes (100 f. L to 150 f. L) Granulocytes (150 f. L to 450 f. L)

ICSH (International council for Standardization of Hematology) Cyanmethemoglobin is the reference method but contains Potassium cyanide. ABX customer can choose between 2 lyses. _ “Alphalyse” (Cyanmethemoglobin) _ “Lysebio” (cyanide free lyse) Principle: • Lyses all red blood cells • Photometry method

Flags and alarms Normal limits «H» : Result above upper set-up limit «L» : Result under lower set-up limit Default analysis “*” : Reject 3 counts were not correlated “$” : Reject 2 of 3 counts were correlated “!” : Reject HGB blank outside the limit

RBC/PLT Flags Morphology flag “MIC” Microcytes “SCH” Schizocytes or Platelet clumps “SCL” Small cells in the 2 and 3 fl area

WBC Flags Morphology flag “L 1” Plt aggregates NRBC Atypical Lymphocytes “M 2” Lymphoblast Myelocytes Abnormal Lymphocytes Basophilia “G 1” Eosinophilia Myelocytes Hypo-segmented neutrophils “G 2” Hyper-segmented neutrophils Lyse problem Old blood “G 3” Metamyelocytes Large immature cells

Data management RS 232 interface Smart card based memory (60 samples per card) Quality control With smart card : • Lowest and highest value • Mean • 2 SD, CV% • Levey-Jennings charts

• Product specification • Measurement principle • Conclusion

Strengths Easy to use Open tube or closed tube Optional reagent pack Sampling volume of 10 µl high reliability without routine maintenance Small reagent consumption Low power consumption Optional smart card reader for data storage and automated QC Alpha-numeric patient identification Automatic probe wipe More than 25 000 ABX MICROS are already installed world-wide

ABX Micros 60