Product specification Software specification Performance Overview Reagents Controls

• Product specification • Software specification • Performance • • • Overview Reagents Controls Parameters Sampling Rack loader Methods & technologies Flags and alarms Customer maintenance Environmental protection

Overview Touch screen Reagent Compartment Rack Loader 10 racks of 10 tubes Processed Tubes Stat Sample Bay

Overview Compact bench top system No external computer is requested 12 inches 54 cm Size: 34. 1 x 23. 3 x 22 in Weight: 55 kg / 122 lb 57 cm 82 cm

Reagents 5 reagents ABX ABX + ABX Cleaner Biolyse Basolyse II Eosinofix Diluent Onboard reagents

Reagents ABX Pentra 80 provides : Cyanide free lyse Small cubitainer volumes Bar- codes, batch number, level count down, logs Waste level sensor

Control bloods CBC & 5 DIFF control bloods : Bar-codes, batch number, expire date, logs Target values uploaded by floppy disk Multi-language package insert CE marking

Parameters CBC Mode (12 Parameters) WBC, RBC, HGB, HCT, MCV, MCHC, RDW, PLT, MPV, PCT, PDW 5 DIFF Mode ( 26 Parameters) WBC, RBC, HGB, HCT, MCV, MCHC, RDW, PLT, MPV, PCT, PDW LYM, MON, NEU, EOS, BASO (% and #) ALY (Atypical Lymphocytes) (% and #) LIC (Large Immature Cells) (% and #) 80 samples per hour Manual or automatic CBC or DIF

Sampling ABX patented the MDSS concept: Whole blood micro-sampling 30 µl (CBC) 53 µl (CBC+DIFF) No sampling valve No maintenance No clogging Customised Dilution Ratio Extended linearity without manual intervention

sampling Automatic mode Random access 30 µl (CBC) 53 µl (CBC+DIFF) Manual (open or close) mode Internal and external bar-code reader

Rack loader Correction of tube height Position check Automatic correction of a wrongly positioned tube Automatic checking of tube presence Accurate rack identification to avoid errors on sample ID Rack identification

Rack loader Rotation swirling End-over-end mixing (reference method Tube identification Accurate tube identification to avoid errors on sample ID

Methods and technologies RBC/PLT - Impedance The impedance principle is based on the reference method HGB - Spectro-photometry HCT - Numeric integration WBC - Impedance & optical BASO - Impedance & specific lyse

Methods and technologies DHSS 1. Cytochemistry Lyses red blood cells Stains nuclei and cytoplasmic granules of leukocytes Fixes the leukocytes in their original state (48 hours post-draw stability) 2. Double hydrodynamic focusing Hydrodynamic focusing before and after the calibrated micro-aperture 3. Focused Flow Impedance Cell volume by impedance method 4. Light absorbance Analysis of the internal structure by measuring the light absorbance of cells

Methods and technologies RBC/PLT - Impedance The impedance principle is based on the reference method HGB - Spectro-photometry HCT - Numeric integration WBC - Impedance & optical BASO - Impedance & specific lyse

Product specification Methods & technologies Methods and technologies The determination of the 5 per differential uses : X -> Cellular volume Y ->Intensity of staining Eosinophils Large Immature Cells Neutrophils Lymphocytes Monocytes Atypical Lymphocytes

Methods and technologies RBC/PLT - Impedance The impedance principle is based on the reference method HGB - Spectro-photometry HCT - Numeric integration WBC - Impedance & optical BASO - Impedance & specific lyse

Flags and alarms General flags • “l” and “h” “L” and “H” “x” “!” (normal limit) (panic limit) (reject) (suspicion) • Pathologic messages RBC and PLT curves

Flags and alarms 5 per differential matrix 1 - Priority alarms ALY: (Atypical Lymphocytes) Atypical Lymphocytes Plasmocytes, hairy Cells LIC: (Large Immature Cells) Blasts, myelocytes Promyelocytes, Metamyelocytes

Flags and alarms 5 per differential matrix 2 - Separation alarms Nl: (Neutro-lympho) Hypo-segmented neutrophils Sezary cells, hairy cells Ne: (Neutro-eosino) Hyper-segmented neutrophils Hypo-granular eosinophils Mn: (Mono-neutro) Immature granulocytes, band cells

Flags and alarms 5 per differential matrix 3 - Zone alarms No: (Noise) Platelet aggregates, NRBCs Lysis resistant RBCs Ln: (Left-neutro) Cellular debris Ll, Ll 1: (Left-lympho) Platelet aggregates, NRBCs Rm: (Right-mono) Large monocytes, blasts Rn: (Right-neutro) Immature granulocytes

Customer maintenance Only one automatic shut-down per day Stepper motors replace the old compressor concept -> No noise, no maintenance A double needle replace the old shear valve concept -> Small sampling volume w/o maintenance Liquid valve replace the old pinch valve concept -> No clogging, no maintenance

Environmental protection Liquid waste 32 ml / sample

Environmental protection Solid waste 1, 83 g / sample Product specification Environmental protection

Environmental protection Product specification Environmental protection Power Requirements Power supply From 100 Vac to 240 Vac (50 HZ to 60 Hz) Power consumption Maximum 230 VA

• Product specification • Software specification • • • Performance • • • System specification Worklist Results Data processing Validation station

System Colour LCD touch screen: 12 inches Windows XP Floppy disk CD ROM drive 1 x. RS 232 C, 2 x. USB port, 1 x Ethernet port Random access (DIFF or CBC mode) Onboard validation-station Onboard user manuel User defined flagging Several operator Ids (4 access levels) Real-time management of patient’s report Automatic re-run with user-defined dilution factor (CDR)

System Contextual toolbar Actions toolbar

System Mono or bi-directional connection: ASTM or ABX format Transfer of Demographic data Test data Blood type(man, woman, child) Tests requested (CBC, CBC/DIFF) Query Mode

System Qualify assurance management Bar-codes Lot number Expiration date Logs 24 QC files XB Levey-Jenning graphs

System Logs for : Maintenance Calibration Controls Errors Data Handling Patient record Settings Logs access by date Blank cycles Connection

Worklist Real time visualisation Easy to set up Maximum security Manual entry or host connection Demographic data, department. . . Comment

Result 26 parameters 3 histograms & 1 matrix Zoom capability User-defined printout header Pathological messages Comments

Data processing Status screen Result statistics Cycles counters Rack processing Reagent management Remaining level Lot number Bar-code Expired date

Data processing Virtual view from rack performed Rack number Tube position Color code for type test Access to patient data by tube touch

Validation station Automatic validation with user-defined : Flags Alarms Limits Delta check Old # D+ % DNew

Validation station On the same screen Patient history Run Re-run (w or w/o dilution) Patient report built from: Run Re-run Manual entry

Validation station Manual entry 5 Diff +Immature cells NRBC’s 100% diff control Automatic calculations Pathology level entry Comments entry

Validation station Archives management 10. 000 patient reports With curves and matrix Flags, comment Search capability by: Date or patient ID

• Product specification • Software specification • Performance • Linearity • Precision • Accuracy • Standards and Directives

Linearity Specifications - Performance Linearity limits were obtained and validated using the following dilution ratio: - WBC/LMNE 1/3 - RBC/HGB/PLT 1/2

Precision Parameters WBC RBC HGB HCT RDW PLT MPV NE% LY% MO% EOS% BAS% %CV <1. 5 % <1. 0 % <1. 5 % <2. 0 % <5. 0 % <3. 0 % <4. 0 % <8. 0 % <15. 0 % <20. 0 % Range 4. 0 - 11. 0 103 /µl 4. 0 - 6. 0 106 /µl 11. 0 - 18. 0 g/dl 35 - 55% 80 - 100 150 - 400 103 /µ 7. 6 - 10. 9 50 - 80% 25 - 50% 2 - 10% 0 - 5% 0 - 2%

Accuracy Parameters WBC RBC HGB HCT PLT Mean % difference <3 <3 <3 <4 <5 Mean difference 0. 2 0. 10 0. 3 1. 5 10

Standards and Directives 98/79/EC - IVD medical devices 89/336/EEC - EMC 73/23/EEC - Low voltage Standards IEC 61010 -1: 1990 + A 1: 1992 + A 2: 1995 EN 61326 : 1998 EN 61000 -3 -2 : 1995 EN 61000 -3 -3 : 1998 CSA - C 22. 2 No. 1010 -1 : 1992 UL 3101 -1 : 1993

• Product specification • Software specification • Performance • Features • Main features • Exclusive features

Main features Qualification & quantification of ALY and LIC Automatic and immediate rerun Real open tube and close tube for manual mode Real capillary mode (30 µl for CBC, 53µl for CBC+Diff) Integrated validation station Compact, simple, reliable (no shear valve, no compressor, only one PCB) Small reagent consumption Automatic shutdown cycle Low power consumption