Analyticon Biotechnologies AG Lichtenfels - Germany

Basics of Hematology Hemolyzer ®

Measuring Principles Laser light scatter technology for 5-part WBC differential Impedance measurement for WBC, RBC und PLT Light absorbance for measuring HGB 3-diff (H3) impedance only

Types of blood cells RBC: 95% of all blood cells PLT: ~4.8% of all blood cells WBC: ~0.2% of all blood cells NEU: 40-75% LYM: 20-45% MON: 2-8% EOS: 1-6% BAS: 0-1% 95% RBC 40-45% of Blodd volume = RBC (hematocrit) Neu ~ 40-75% of WBC target & destroy bacteria, virusses & fungi Lym ~ 20-45% of WBC (B-; T-; & NK-cells) identify & attack „invaders“ & infected/abnormal cells Mon ~ 2-8% of WBC Monophages (waste disposal) & dendritic cells (showcasing antigens to activate T-cells) Eos ~ 1-6% of WBC target mlticellular parasites Bas ~ 0-1% of WBC release histamin, involved in asthma & allergies

WBCs selectively shrank to nuclei Differential Lysing Process PLT & RBC LYM MON GRAN RBCs destroyed WBCs selectively shrank to nuclei

3-part Differential WBC Histogram PLT & RBC LYM MON GRAN & HGB

4-part Differential WBC Scattergram Eosinophiles Neutrophiles Basophiles cannot be reliably differentiated from the rest of the white blood cells Additional optical count is needed High angle forward scatter Complexity Monocytes Lymphocytes Size Low angle forward scatter RBC GHOST

Hemolyzer® 3

Hemolyzer® 3 Provides 20 parameters CBC including 3-part WBC differential 3 Histograms: WBC, RBC, PLT Throughput: 60 samples per hour 6 QC lots, Levey-Jennings diagrams Database capacity: 10,000 Only 3 reagents (cyanide-free) Automatic monitoring of reagent status

Hemolyzer® 3 Sample Volume: 25 μl (open tube sampling) Automatic clogging prevention Large, high resolution colour LCD Easy, intuitive operation Interfaces: RS232, USB Printout via internal thermal printer (optional also via external printer) Compact design: 350 x 490 x 385 mm Weight: 15 kg

Hemolyzer® 3: Maintenance Daily Maintenance Hemolyzer Hypocleaner is inserted as sample and “measured”

Hemolyzer® 3: Key Benefits Safe Operation The sample is being aspirated inside the analyzer, practically excluding the risk of injuries for the user High speed Results within 60 seconds Reliable Instrument Easy maintenance by the user

Hemolyzer® 3: Competitors Model Hemolyzer® 3 Cell-dyn® 1800 AC•T Diff AC•T Diff2 ABX Micros 60 Distributor Analyticon Abbott Beckman Coulter Horiba   WBC diff. 3 Number of parameters 20 18 Histograms WBC, RBC, PLT Throughput (PT/h) 60 50 60 (open); 55(closed) Sample volume [μl] 25 30 12 10 Open/Closed sampling ü/- ü/ü STAT Function ü Number of reagents Bar code reader optional Autoloader (capacity) - Colour display Touch Screen Internal printer RS-232/USB  ü/- Database capacity 10,000 250 1; 78 (with smart card) QC Levey-Jennings Levey-Jennings, IQAP Dimensions Size (WxDxH) [cm] 35x49x38.5 66x44x52 38x42x39 45x49x40 36x42x32 Weight [kg] 15 55 16 14 Operating temperature 15-35°C 18-30°C 16-34°C

Hemolyzer® 3: Competitors Model Hemolyzer® 3 M 16M/C/20M/C M 16S/20S CA 620 KX 21 Distributor Analyticon Medonic Sysmex   WBC diff. 3 Number of parameters 20 16/20 9/16/20 18 Histograms WBC, RBC, PLT Throughput (PT/h) 60 65 Sample volume [μl] 25 100 (open); 250 (closed) 300 125 50 Open/Closed sampling ü/- ü/ü (C only) ü/ü ü/optional STAT Function ü Number of reagents 2 Bar code reader optional Autoloader (capacity) - ü (2x20) Colour display Touch Screen Internal printer RS-232/USB  ü/ü Database capacity 10,000 220 QC Levey-Jennings Dimensions Size (WxDxH) [cm] 35x49x38.5 29x41x46 33x43x46 42x35x46 42x48x36 Weight [kg] 15 22 28 Operating temperature 15-35°C 18-32°C

Hemolyzer® 3: Competitors Model Hemolyzer® 3 BC 3000+ BC 3200 BC 3600 Distributor Analyticon Mindray   WBC diff. 3 Number of parameters 20 19 21 Histograms WBC, RBC, PLT Throughput (PT/h) 60 Sample volume [μl] 25 13 Open/Closed sampling ü/- -/ü ü/optional STAT Function ü Number of reagents 5 Bar code reader optional Autoloader (capacity) - Colour display Touch Screen Internal printer RS-232/USB ü/ü Database capacity 10,000 35000 40000 QC Levey-Jennings Dimensions Size (WxDxH) [cm] 35x49x38.5 39x46x40 39x46x42 45x40x45 Weight [kg] 15 28 Operating temperature 15-35°C 15-30°C

Hemolyzer® 3: Competitors Model Hemolyzer® 3 Celltac α MEK-6400/6410/6420 Mythic 18 H18 light Celly Plus Distributor Analyticon Nihon Kohden Orphee SFRI Biocode Hycel   WBC diff. 3 Number of parameters 20 18 Histograms WBC, RBC, PLT Throughput (PT/h) 60 63 Sample volume [μl] 25 30 9.8 9.6 10 Open/Closed sampling ü/- ü/ü STAT Function ü Number of reagents 4 Bar code reader optional Autoloader (capacity) - Colour display Touch Screen Internal printer RS-232/USB Database capacity 10,000 400 1,500 20,000 1,000 QC Levey-Jennings Dimensions Size (WxDxH) [cm] 35x49x38.5 23x45x38.3 25x34x35 33x43x38 32x35.2x36.8 Weight [kg] 15 9 23 9.5 Operating temperature 15-35°C 18-35°C

Hemolyzer® 5

Hemolyzer® 5 Provides 24 parameters CBC including 5-part WBC differential 2 Histograms: RBC, PLT 2 Scattergrams: 4-diff WBC, BASO Throughput: 60 samples per hour 6 QC lots, Levey-Jennings diagrams Database capacity: 100,000 Only 3 reagents (cyanide-free) Automatic monitoring of reagent status

Hemolyzer® 5 Sample Volume: 100 μl (open/closed, whole blood) Automatic clogging prevention Large colour LCD touch screen Easy, intuitive operation Autoloader (100 samples) optional Interfaces: RS232, USB Printout via external Microsoft® WindowsTM compatible printers

Hemolyzer® 5: Dimensions Compact design: 410 x 465 x 515 mm Weight: 35 kg (with autoloader: 49 kg)

Hemolyzer® 5: Autoloader Plug-In; can be added any time Based on linear racks Up to 100 samples (10 racks) Cap recognition and cap piercing Monovette®, Vacutainer®, Vacuette® Integrated barcode reader Integrated sample mixer Using the same sample needle

Hemolyzer® 5: 4-Diff Scattergram Eosinophiles Neutrophiles High angle forward scatter Complexity Monocytes Lymphocytes Size Low angle forward scatter RBC GHOST

Hemolyzer® 5: Basophile Scattergram in the 4-part differential the basophiles cannot be reliably differentiated from the rest of the white blood cells additional optical count is needed for basophiles in the WBC/HGB dilution all WBC’s are (over)lysed with the exception of the basophiles after the impedance count the WBC/HGB dilution is transferred to the optical head for BASO count

Hemolyzer® 5: Maintenance Daily Maintenance Hemolyzer Hypocleaner is inserted as sample and “measured” Regular Maintenance (depending on throughput) Cleaning of measurement head Cleaning of shear valve

Hemolyzer® 5: Key Benefits Safe Operation The sample is being aspirated inside the analyzer, practically excluding the risk of injuries for the user Patented Laser Technology High speed Results within 60 seconds Reliable Instrument Easy maintenance by the user Autoloader (100 samples) Upgrade can be done at any time

Hemolyzer® 5: Competitors Model Hemolyzer® 5 Cell-dyn® 3200 CS Cell-dyn® 3200 AL Cell-dyn® 3700 CS Cell-dyn® 3700 SL Distributor Analyticon Abbott   WBC diff. 5 Number of parameters 24 22 23 Histograms RBC, PLT Scattergrams 4diff (L-M-N-E), BAS WBC, RBC, PLT, RET WBC, RBC, PLT, Throughput (PT/h) 60 71 72 90 Sample volume [μl] 100 240 (closed); 150 (open) 240 (closed); 130 (open) 355 (AL); 240 (closed); 130 (open) Open/Closed sampling / STAT Function  Number of reagents 3 4 Bar code reader optional Autoloader (capacity) optional (100) -  (50)  (100) Standalone Touch Screen Internal printer RS-232/USB 1/4 /- Database capacity 100,000 10,000 QC Levey-Jennings Dimensions Size (WxDxH) [cm] 40x45x50 83x48x59 83x48x74 76x61x56 76x68x79 Weight [kg] 35 97 106 86 131

Hemolyzer® 5: Competitors Model Hemolyzer® 5 AC•TTM 5 Diff OV/CP AC•TTM 5 Diff AL HmX ABX Pentra (XL) 80 Distributor Analyticon Beckman Coulter Horiba   WBC diff. 5 Number of parameters 24 26 Histograms RBC, PLT WBC, RBC, PLT Scattergrams 4diff (L-M-N-E), BAS 4diff (L-M-N-E)  Throughput (PT/h) 60 80 75 Sample volume [μl] 100 53 (CBC + diff); 30 (CBC) 185 (closed); 125 (open) Open/Closed sampling / / (CP) STAT Function Number of reagents 3 Bar code reader optional Autoloader (capacity) optional (100) -  (100) Standalone  (OV)/-(CP) Touch Screen Internal printer  (laser) RS-232/USB 1/4 /2 Database capacity 100,000 10,000 5,000 QC Levey-Jennings IQAP Dimensions Size (WxDxH) [cm] 40x45x50 44.4x58x50.1 81.5x58x54 61.5x61.7x84.8 82x57x54cm Weight [kg] 35 36.2 55 94.5

Hemolyzer® 5: Competitors Model Hemolyzer® 5 BC 5300 BC 5380 BC 5500 BC 5800 Distributor Analyticon Mindray   WBC diff. 5 Number of parameters 24 27 29 Histograms RBC, PLT 3 Scattergrams 4diff (L-M-N-E), BAS 1 Throughput (PT/h) 60 80 (AL); 60 (manual) 90 Sample volume [μl] 100 20 (CBC + diff); 15 (CBC) 180 (closed); 120 (open) Open/Closed sampling / /- STAT Function  Number of reagents 6 Bar code reader optional Autoloader (capacity) optional (100) -  (30) optional (50) Standalone Touch Screen Internal printer RS-232/USB 1/4 /4 /5 Database capacity 100,000 40,000 QC Levey-Jennings Dimensions Size (WxDxH) [cm] 40x45x50 41x53x47 66.4x61.3x58.5 66.4x61.3x58.6 Weight [kg] 35 45 73 76

Hemolyzer® 5: Competitors Model Hemolyzer® 5 XS 800i XS 1000i XT 1800i/2000i Distributor Analyticon Sysmex   WBC diff. 5 Number of parameters 24 24/31 Histograms RBC, PLT Scattergrams 4diff (L-M-N-E), BAS  4diff, WBC/Baso, PLT, Ret (2000i) Throughput (PT/h) 60 60; AL: 52 80 Sample volume [μl] 100 20 85; 150 (AL) Open/Closed sampling / /- STAT Function Number of reagents 3 4 Bar code reader optional Autoloader (capacity) optional (100) - optional (20) Standalone Touch Screen Internal printer RS-232/USB 1/4 Database capacity 100,000 10,000 QC Levey-Jennings Dimensions Size (WxDxH) [cm] 40x45x50 32x50x41 32x40x41 53x63x50 Weight [kg] 35 52

Hemolyzer® 5: Competitors Model Hemolyzer® 5 Celltac E MEK-7222 Celltac E MEK-8222 Mythic 22 OT/CT Mythic 22 AL Distributor Analyticon Nihon Kohden Orphee   WBC diff. 5 Number of parameters 24 22 Histograms RBC, PLT  Scattergrams 4diff (L-M-N-E), BAS 5-diff Throughput (PT/h) 60 51 80 50(OT)/45(CT) Sample volume [μl] 100 55 (CBC + diff); 30(CBC) 56 (CBC + diff); 30 (CBC) 17 (OT)/20 (CT) 20 Open/Closed sampling / /optional / (CT only) STAT Function Number of reagents 3 Bar code reader optional Autoloader (capacity) optional (100) -  (50) Standalone Touch Screen Internal printer RS-232/USB 1/4 1/2 1/5 Database capacity 100,000 1,500 QC Levey-Jennings Dimensions Size (WxDxH) [cm] 40x45x50 61.3x58.3x55 25x34x35 48x40x40 38.2x48.5x52 Weight [kg] 35 55 11 25 38