Product Fact Sheet Added values XN-CBC and XN-DIFF

Transcription

1 Added values XN-CBC and XN-DIFF Clinical values Product name Reliable NRBC counts for all neonate and adult samples of low and high counting ranges enable immediate therapeutic action, e.g. for patients in ICU Highly sensitive detection of WBC abnormalities with improved flagging nomenclature guide to quick patient diagnosis Support of detection of inflammations or infections and in therapy monitoring of infections Added value XN-CBC Added value XN-DIFF Manufacturer information Sysmex Corporation Summary Specifications Feature Discrete mode Sampling mode Whole blood mode Analysis time Description CBC and CBC+DIFF Whole blood mode Low-WBC mode Pre-dilution mode 36 s XN-Series offers a high analytical level of screening by fluorescence flow cytometry for the counting/differentiation of white blood cells in CBC and DIFF mode. The advanced XN-CBC profile includes the counting of rare event cells as basophils and nucleated red blood cells in every measurement. It reports NRBC as low as 0./00 WBC. Furthermore, interferences from non-cellular particles such as lyse-resistant RBC or lipids are avoided.the XN instrument always reports automatically corrected WBC values if NRBC are present. The differential of the XN-Series includes the counting of immature granulocytes (IG) and provides high sensitivity detection of WBC abnormalities. Samples showing a low white blood cell concentration can be re-measured automatically in the special low WBC mode. This ensures obtaining reliable results of all parameters including the differential by an extended count sequence. An additional dedicated pre-diluted mode is designed for the analysis of capillary samples as only 20 μl of blood is required. Productivity values Decreased turn-around time (TAT) as no reflex testing for NRBC is needed in all profiles Reducing smears and potential manual errors by eliminating manual NRBC counts and by an improved flagging efficiency for WBC Always correct WBC values in neonate samples by autocorrection for NRBC Low-WBC mode Analysis time Pre-dilution mode Analysis time Dilution ratio Technologies Reflex testing optional available for Diagnostic parameters 4 s 40 s :7 Fluorescence flow cytometry Hydrodynamic focussed impedance measurement Light emitting diode (LED) photometry Adaptive cluster analysis system (ACAS) and special shape recognition analysis of each WBC subpopulation Myeloid and lymphatic information Critical PLT information Low-WBC mode XN-CBC (6, incl. NRBC) WBC White blood cell count NRBC%, NRBC# Nucleated red blood cells RBC Red blood cell count HGB Haemoglobin HCT Haematocrit MCV Mean corpuscular volume MCH Mean corpuscular haemoglobin MCHC Mean corpuscular haemoglobin concentration PLT Platelet count (PLT-I) Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 0/08/205 by Melanie Steffens - Page / 3

2 Product Name or Title XN-DIFF (2) Research parameters XN-CBC (6) XN-DIFF (28) Service parameters RDW-SD Red cell distribution width (standard deviation) RDW-CV Red cell distribution width (coefficient of variation) PDW Platelet distribution width MPV Mean platelet volume P-LCR Platelet large cell ratio PCT Plateletcrit NEUT%, NEUT# Neutrophils LYMPH%, LYMPH# Lymphocytes MONO%, MONO# Monocytes EO%, EO# Eosinophils BASO%, BASO# Basophils IG%, IG# Immature granulocytes Microcytic red blood cell ratio (MicroR) Macrocytic red blood cell ratio (MacroR) WBC-N BA-N#, BA-N% Total nucleated cell count WNR channel (TNC-N) Total nucleated cell count DIFF channel (TNC-D) WBC-D (TNC-D - NRBC#) High fluorescence lymphocyte count (HFLC#, HFLC%) NEUT#& (NEUT# - IG#) NEUT%& (NEUT% - IG%) LYMP#& (LYMPH# - HFLC#) LYMP%& (LYMPH% - HFLC%) Basophils analysed in the DIFF channel (BA-D#, BA-D%) Neutrophil granulation (NE-SSC) Neutrophil fluorescence (NE-SFL) Neutrophil FW scatter (NE-FSC) Lymphocyte SW scatter (LY-X) Lymphocyte fluorescence (LY-Y) Lymphocyte forward scatter (LY-Z) Monocyte side scatter (MO-X) Monocyte fluorescence (MO-Y) Monocyte forward scatter (MO-Z) Neutrophil side scatter width (NE-WX) Neutrophil fluorescence width (NE-WY) Neutrophil FW scatter width (NE-WZ) Lymphocyte side scatter width (LY-WX) Lymphocyte fluorescence width (LY-WY) Lymphocyte FW scatter width (LY-WZ) Monocyte side scatter width (MO-WX) Monocyte fluorescence width (MO-WY) Monocyte FW scatter width (MO-WZ) 29 (XN-CBC) and 6 (XN-DIFF) Linearity (whole blood mode) WBC RBC HGB HCT MCV NRBC# NRBC% NEUT% LYMPH% MONO% EO% BASO% IG% Precision (whole blood mode) WBC RBC HGB HCT MCV MCH MCHC RDW-SD RDW-CV PDW MPV P-LCR PCT PLT NRBC# NRBC% NEUT# NEUT% LYMPH# LYMPH% MONO# MONO% EO# Within ±3.0 % or ±0.20 x 0 3 /μl (0.00 to x 0 3 /μl) Within ±6.0 % (00.0 to x 0 3 /μl) Within ±.0 % (30.0 to x 0 3 /μl) Within ±2.0 % or ±0.03 x 0 6 /μl (0.00 to 8.00 x 0 6 /μl) Within ±4.0 % or ±0.06 x 0 6 /μl (8.0 to 8.60 x 0 6 /μl) Within ±2.0 % or ±0.2 g/dl (0.0 to 25.0 g/dl, 0.00 to 5.52 mmol/l) Within ±5.0 % or ±0.5 g/dl (25. to 26.0 g/dl, 5.53 to 6.4 mmol/l) Within ±3.0 % or ±.0 HCT (0.0 to 75.0 %) Within ±3 % or ±2.0 fl Within ±0.0 % or ±0.20 x 0 3 /μl (0.00 to x 0 3 /μl) Within ±20.0 % or ±2.0 NRBC % (0.0 to 600.0/00 WBC) Within ±3.0 NEUT% Within ±3.0 LYMPH% Within ±2.0 MONO% Within ±.0 EO% Within ±.0 BASO% Within ±.5 IG% 3.0 % or less (4.00 x 0 9 /L or more).5 % or less (4.00 x 0 2 /L or more).0 % or less.5 % or less.0 % or less 2.0 % or less 2.0 % or less 2.0 % or less 2.0 % or less 0.0 % or less 4.0 % or less 5.0 % or less 6.0 % or less 4.0 % or less (00 x 0 3 /μl or more) 25.0 % or less, or within ±0.2 x 0 3 /μl 25.0 % or less, or within ±.5 NRBC% (WBC 4.00 x 0 3 /μl or more) 8.0 % or less (.20 x 0 3 /μl or more) 8.0 % or less (30.0 NEUT% or more, WBC 4.00 x 0 3 /μl or more) 8.0 % or less (0.60 x 0 3 /μl or more) 8.0 % or less (5.0 LYMPH% or more, WBC 4.00 x 0 3 /μl or more) 20.0 % or less (0.20 x 0 3 /μl or more) 20.0 % or less (5.0 MONO% or more, WBC 4.00 x 0 3 /μl or more) 25.0 % or less, or within ±0.2 x 0 3 /μl Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 0/08/205 by Melanie Steffens- Page 2 / 3

3 Product Name or Title EO% BASO# BASO% IG# IG% Carry over (pre-dilution mode) WBC RBC HGB HCT PLT NRBC# NEUT# LYMPH# MONO# EO# BASO# Sample stability 8 hours 25.0 % or less, or within ±.5 EO% (WBC 4.00 x 0 3 /μl or more) 40.0% or less, or within ±0.06 x 0 3 /μl 40.0% or less, or within ±.0 BASO% (WBC 4.00 x 0 3 /μl or more) 25.0% or less or within ±0.2 x 0 3 /μl (IG# 0.0 x 0 3 /μl or more) 25.0% or less or within ±.5 IG% (IG% 2.0% or more, WBC 4.00 x 0 3 /μl or more).0 % or less.0 % or less.0 % or less.0 % or less.0 % or less 2.0 % or 0.02 x 0 3 /μl or less 2.0 % or 0.05 x 0 3 /μl or less 2.0 % or 0.05 x 0 3 /μl or less 2.0 % or 0.03 x 0 3 /μl or less 2.0 % or 0.03 x 0 3 /μl or less 2.0 % or 0.03 x 0 3 /μl or less HCT within +5.0 % MCV within +5.0 % 24 hours HCT within +8.0 % (in a refrigerator), within +5.0 % (stored at 8 to 26 C) MCV within +8.0 % (in a refrigerator), within +5.0 % (stored at 8 to 26 C) NRBC% within +0.0 % or ± 3.0/00 WBC IG% within ±2.0 % IG% 36 hours NEUT% within ±8.0 NEUT% LYMPH% within ±7.0 LYMPH% MONO% within ±3.0 MONO% EO% within ±3.0 EO% BASO% within ±.0 BASO% 48 hours PLT within +0% or ± 30 x 0 3 /μl NEUT% within ±8.0 NEUT% LYMPH% within ±7.0 LYMPH% MONO% within ±4.0 MONO% EO% within ±3.0 EO% BASO% within ±.0 BASO% 72 hours WBC within ±0.0% RBC within ±5.0% HGB within ±5.0% References: XN-Series IFU version February 204 Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 0/08/205 by Melanie Steffens- Page 3 / 3

4 Added value RET Early prognosis of therapy monitoring by advanced clinical parameters and their combinations (e.g. RET-He, Delta-H e, IRF) Article number ZE Media Kit RET RET application kit Product name Added value RET Specifications Feature Description Manufacturer information Sysmex Corporation Summary Since anaemia is one of the most common symptoms of many diseases and one of the most underestimated RBC disorders, knowing the erythropoietic status is of prime importance for many patients. Next to the pure count of reticulocytes, the XN-Series added value RET application provides the reticulocyte fractions (IRF, LFR, MFR, HFR) and additional information on the quality of the newly formed RBC by reporting the degree of the haemoglobinisation of the reticulocytes (RET-H e) and red blood cells (RBC-H e). The parameter Delta-H e is derived from the difference between these two parameters. Delta-H e values above the normal range may indicate an improvement in erythropoiesis, for example after EPO and/or iron therapy. In contrast, when Delta-H e values are below the normal range for longer periods, this may indicate the onset of anaemia. In addition, the added value RET application allows obtaining information about hypochromic and hyperchromic RBC, about microcytes and macrocytes as well as fragmentocytes and the automatic calculation of the reticulocyte production index (RPI). Productivity values Quick screening of the erythropoietic status Clinical values Reliable diagnosis of anaemic patients based on the complete picture of the erythropoiesis by qualitative and quantitative information Discrete mode (Depending on XN configuration) Sampling mode Technologies Diagnostic parameters * Research parameters (whole blood mode) CBC+RET CBC+DIFF+RET CBC+DIFF+WPC+RET CBC+DIFF+RET+PLT-F CBC+RET+PLT-F CBC+DIFF+WPC+RET+PLT-F Whole blood mode Low-WBC mode Pre-dilution mode Fluorescence flow cytometry RET% Reticulocyte percent RET# Reticulocyte count HFR High fluorescence ratio MFR Medium fluorescence ratio LFR Low fluorescence ratio IRF Immature reticulocyte fraction RET-H e Reticulocyte haemoglobin equivalent RBC-H e Red blood cell haemoglobin equivalent Delta-H e Difference between RET-H e and RBC-H e HYPO-H e Percent hypochromic red blood cells HYPER-H e Percent hyperchromic red blood cells * RBC-O Red blood cell count (optical) RET-Y RBC-X, RBC-Y IRF-Y FRC% Fragmented red blood cell percent FRC# Fragmented red blood cell count Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 20/04/207 by Michael Preukschas - Page / 2

5 Product Name or Title Service parameters 8 Linearity (whole blood mode) RET% RET# IRF LRF MFR HFR PLT-O RPI Reticulocyte production index RET-UPP RET-TNC PLT-O Within ±20% or ±0.30 RET% (0.00 to 30.00%) Within ±20% or ±0.050 x 0 6 /µl ( to x 0 6 /µl) Within ±30% or ±0.0 IRF% Within ±30% or ±0.0 LFR% Within ±30% or ±0.0 MFR% Within ±30% or ±5.0 HFR% Within ±7% or ±0 x 0 3 /µl (0 to 5,000 x 0 3 /µl) 48 hours at RT and 4 C PLT-O Within +5.0% *Availability of certain diagnostic parameters depends on the IPU software version. Please refer to the release notes of IPU software 2.2 for further information. References: XN-Series IFU version 6 November 206 RIAm: Regional IFU Amendment Sysmex XN series October 206 Precision (whole blood mode) RET% RET# IRF LFR MFR HFR RET-H e RBC-H e PLT-O Precision (pre-diluted mode) RET% RET# PLT-O Sample stability (whole blood mode) 24 hours at RT and 4 C RET% RET# IRF LFR MFR HFR RET-He RBC-He 5.0 % or less (RBC 3.00 x 0 6 /µl or more, RET%.00 to 4.00%) 5.0% or less (RBC 3.00 x 0 6 /µl or more, RET%.00 to 4.00%) 30.0% or less (RBC 3.00 x 0 6 /µl or more, RET%.00 to 4.00%, IRF 20.0% or more) 30.0% or less (RBC 3.00 x 0 6 /µl or more, RET%.00 to 4.00%, LFR 20.0% or more) 50.0% or less (RBC 3.00 x 0 6 /µl or more, RET%.00 to 4.00%, LFR 20.0% or more) 00.0% or less or within ±2.0 HFR% (RBC 3.00 x 0 6 /µl or more, RET%.00 to 4.00 %) 5.0% or less (RET# 0.02 x 0 6 /µl or more) 5.0% or less 6.0% or less (00 x 0 3 /µl or more) 35.0% or less (RBC 3.00 x 0 6 /µl or more, RET%.00 to 4.00 %) 35.0% or less (RBC 3.00 x 0 6 /µl or more, RET%.00 to 4.00 %) 3.0 % or less (00 x 0 3 /µl or more) ± 20.0% or within ±0.3 RET% ± 20.0% or within ±0.05 x 0 6 /µl ± 30.0 % or within ±0.0 IRF ± 30.0% or within ±0.0 LFR ± 30.0% or within ±0.0 MFR ± 30.0% or within ±5.0 HFR Within ± 8.0% (RET# x 0 6 /µl or more) Within ± 8.0% Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 20/04/207 by Michael Preukschas - Page 2 / 2

6 Added value for the leucopoiesis Product Fact Sheet Added value for the leucopoiesis haematology wards, will benefit from a significant smear reduction. False-positive and false-negative rates are both optimised and flagging algorithms effectively support the identification of myeloid and lymphatic malignancies. Product name Added value WPC Manufacturer information Sysmex Corporation Summary High specificity in white precursor and pathological cells (WPC) analysis is provided with a dedicated measurement channel. It is dedicated for detecting malignant white blood cells with high specificity since they feature altered membrane characteristics. If the flags for Blasts/Abn Lympho? or both Atypical Lympho? and Blasts/Abn Lympho? are triggered by the WDF channel, the automated WPC analysis can turn these into one of four more specific flagging messages: Blasts? flag: indicates a suspected acute malignant disorder (e.g. acute leukaemias). Abn Lympho? flag: points to a suspected malignant disorder of lymphocytes (e.g. chronic leukaemias and lymphomas). Atypical Lympho? flag: points to a reactive disorder (e.g. infections or inflammations, allowing the characterisation of the state of the immune system. Negative : The high specificity of WPC analysis further filters out false-positive suspected malignant samples. The WPC analysis is triggered by a reflex testing after a positive detection in the CBC+DIFF mode. But for known special samples, e.g. from oncology wards, the profile may also be ordered initially. The WPC channel s high specificity is contributing further to improve the laboratory workflow after the sensitive screening for WBC abnormalities in the CBC+DIFF profile. Especially laboratories handling a large number of samples with such abnormalities, e.g. from oncology or The WPC channel further enables to use the optional XN Stem Cell mode. * * Only available after activation of XN Stem Cells license Productivity values Minimisation of the number of false-positive suspected malignant samples from the XN-DIFF, thus streamlining the diagnostic pathway by reduction of follow-up tests Confidence that the right smears are performed Decreased TAT time thanks to automatic reflex testing Clinical values Optimal differentiation between malignant and reactive samples and deeper insight into the immune response status once malignant conditions have been excluded Assuring that the right smears are done and no time is invested in false positive samples Faster follow-up of true pathological samples can become beneficial during the treatment process Article number ZE Media Kit WPC WPC precursor kit Specifications Feature Discrete mode (depending on XN configuration) Description CBC+DIFF+WPC CBC+DIFF+WPC+RET* CBC+DIFF+WPC+RET*+PLT-F* CBC+DIFF+WPC+PLT-F* *optional Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 28//206 by Telmo Costa - Page / 2

7 Added value for the leucopoiesis Sampling mode Technologies Whole blood mode Low WBC mode Capillary/pre-diluted mode Fluorescence flow cytometry Diagnostic parameters HPC% and HPC# Reflex testing Flagging information Sample stability whole blood mode Haematopoietic progenitor cell count only available after license activation (for more information refer to XN Stem Cells PFS) Automatically triggered by the XN-DIFF flag Blasts/Abn Lympho? Blasts? flag Abn Lympho? flag Atypical Lympho? flag Negative 24 hours at RT and at 4 C References: XN-Series Instructions for Use Revised January 206 Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 28//206 by Telmo Costa - Page 2 / 2

8 XN CHECK Product Fact Sheet XN CHECK Specifications Feature Concentration Description Available in three concentration levels named L, L2 and L3 to cover the abnormal low, normal and abnormal high concentration range. Product name XN CHECK Manufacture information Sysmex Corporation, Japan "Producer" on OEM-Basis: STRECK, U.S.A. Summary The XN CHECK is a control blood designed to fit specifically to the XN-Series and XN-L Series instrumentation thus allowing to thoroughly checking the analysers technical functions and reagent system. The material enables an effective and reliable internal and external quality control of the XN-Series and XN-L Series haematology system. Parameter Composition Application on Measurement mode Temperature of use Storage Period of use RBC, HGB, HCT, MCV, MCH, MCHC, RDW-SD, RDW-CV, MicroR, MacroR PLT(-I), PLT-F*, PDW, PCT, MPV, P- LCR, IPF (%,#)* WBC, WBC-D, WBC-P*, NEUT (%,#), LYMPH (%/#), MONO (%/#), EO (%,#), BASO (%,#), NRBC* (%/#), IG (%/#), HPC (%,#)*, AS-LYMP (%,#)* RET(%,#), HFR, MFR, LFR, IRF, RET- He, RBC-He, Hypo-He, Hyper-He, RBC- O, PLT-O * not on XN-L Series Stabilised human red blood cells, human white blood cells, a platelet and nucleated red blood cell component in a preservative medium. XN-Series and XN-L Series Control mode Room temperature 2-8 C before and after opening 8 weeks per lot Open vial stability 7 days if stored at 2-8 C. Volume 3.0 ml per vial Article number Article no. Item XN CHECK L XN CHECK L2 XN CHECK L3 XN CHECK L XN CHECK L2 XN CHECK L3 Quantity x 3.0 ml x 3.0 ml x 3.0 ml 8 x 3.0 ml 8 x 3.0 ml 8 x 3.0 ml Dead volume IFU (package insert).0 ml per vial The package inserts for XN CHECK are enclosed to the product as paper sheets in four languages only (English, French, Spanish, Portuguese). They are available in 23 languages for download on The clam shell labels of both products reflect that situation by displaying this website for download of package inserts. ZE XN CHECK / XN CHECK BF USB stick (for XN-L Series) Assay data Provided as assay mean and assay Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 05/0/207 by Sandra Valdmanis - Page / 2

9 XN CHECK range. Assay files Assay data is provided in electronic format for each lot and level of XN CHECK on CD-ROMs (for XN-Series) USB sticks (for XN-L Series & XN-Series). Assay data input Upload of assay data from assay CD-ROM (XN-Series) and assay USB stick (XN-L Series & XN- Series). Manual data input by manual typing. Manual bar code data input (for XN-L Series): read in assay data via the barcode reader External QC: SNCS IQAS Online Sysmex is offering the Sysmex Network Communication System (SNCS), which is an Internet based platform for online services. Part of SNCS is IQAS Online, which is based on the use of XN CHECK and XN CHECK BF and provides external quality control to continuously monitor the XN and XN-L Series performance range. That includes all diagnostic parameters as well as purely technical parameters (sensitivity parameters). Bornbarch, Norderstedt, Germany Phone Fax Last updated on 05/0/207 by Sandra Valdmanis - Page 2 / 2

10 XN-0 Product Fact Sheet XN-0 Product name Reagents for XN-CBC XN-0 with the standard Clinical Value applications SULFOLYSER Lysing reagent (politainer) to detect HGB 5 L Manufacturer information Sysmex Corporation AN BL253 Lysercell WNR Surfactant (paper pack) to detect WBC and NRBC Surfactant (politainer) to detect WBC and NRBC 4 L 5 L Summary As the analysis module of the XN-solution portfolio, the XN-0 delivers an efficient processing of the sample analysis. Its technical performance provides reliable and accurate test results by applying a maximum of six measurement channels. The XN-0 can process primary sample tubes in sampler and manual mode via the same aspiration line. Further, micro tube samples and body fluid samples (with the optional XN-BF application) can be measured in the manual mode immediately. Article numbers Instruments AP XN-0 complete Analysis module Reagents for dilution* AJ37080 BQ CELLPACK DST CELLPACK DST Concentrated diluent (politainer) for preparation by RPU Concentrated diluent (politainer) for preparation by RPU 20 L 0 L CT66628 CELLPACK DCL Diluent (politainer) 20 L CU CELLPACK DCL Diluent (politainer) 0 L * Either CELLPACK DCL or CELLPACK DST is connected CP06675 Reagents for XN-DIFF Fluorocell WNR Labelling reagent (cartridge) to detect WBC and NRBC 82 ml AW AL CV Lysercell WDF Reagents for XN-RET Fluorocell WDF Surfactant (paper pack) to obtain the WBC differential Surfactant (politainer) to obtain the WBC differential Labelling reagent (cartridge) to obtain the WBC differential 4 L 5L 42 ml BT96590 BN CELLPACK DFL Fluorocell RET Reagents for XN-PLT-F Surfactant (paper pack) to detect RET and PLT Labelling reagent (cartridge) to detect RET and PLT-O.5 L 2mL BT96590 CD CELLPACK DFL Fluorocell PLT Surfactant (paper pack) to detect RET and PLT Labelling reagent (cartridge) to detect PLT-F.5 L 2 ml Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 30//205 by Melanie Steffens - Page / 2

11 XN-0 Quality control Feature Description XN CHECK L Whole blood QC level for XN 8 x 3 ml Discrete mode profiles Standard: CBC (NRBC) XN CHECK L XN CHECK L XN CHECK BF L and L2 Whole blood QC level 2 for XN Whole blood QC level 3 for XN Body fluid QC level and 2 for XN 8 x 3 ml 8 x 3 ml 3 x 3 ml CBC (NRBC) + DIFF Optionals (depending on the configuration): CBC+RET CBC+DIFF+RET CBC+DIFF+RET+PLT-F CBC+RET+PLT-F XN CAL Calibrator material 3 x 3 ml CBC+PLT-F CBC+DIFF+PLT-F Body fluid Specifications Feature Number of diagnostic parameters* Number of research parameters* Description Standard: CBC+DIFF: 28 Optional: RET: 7 PLT-F: 2 BF: 7 Standard: CBC+DIFF: 34 Optional: RET: 5 PLT-F: 2 BF: * For further details please refer to the Product Fact Sheets (PFS) on Added Values available on the Sysmex Extranet Sampling mode Aspiration volume Sampler mode Manual open mode Manual closed mode Pre-dilution mode Micro analysis Body fluid mode Required sample volume Whole blood mode: Sampler mode Manual closed Manual open Pre-dilution mode: Manual open Body fluid mode: Manual closed Manual open Operative temperature Standard: Whole blood mode Low WBC mode Pre-dilution mode Optional: Body fluid mode 88 µl 88 µl 88 µl 70 µl 88 µl (micro tube) 88 µl ml ml 300 µl (regular tube) 60 µl (micro tube) 300 µl (regular tube) 40 µl (micro tube) ml 300 µl (regular tube) 60 µl (micro tube) 5 C to 30 C Operative humidity 30 % to 85 % Power requirement AC 00 to 240 V (50/60 Hz) Power consumption 270 VA or less Reference: XN IFU EU 05 Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 30//205 by Melanie Steffens - Page 2 / 2

12 XN-20 Product name Reagents for XN-CBC XN-20 with the standard applications SULFOLYSER Lysing reagent (politainer) to detect HGB 5 L Manufacture information Sysmex Corporation AN BL253 Lysercell WNR Surfactant (paper pack) to detect WBC and NRBC Surfactant (politainer) to detect WBC and NRBC 4 L 5 L Summary As the analysis module of the XN solution portfolio, the XN-20 provides reliable and accurate test results by applying a maximum of seven measurement channels, including one dedicated to white precursor cells (WPC). The XN-20 can process primary sample tubes in sampler and manual mode via the same aspiration line. Micro tube samples and body fluid samples (with the optional XN-BF application) can be measured in the manual mode immediately. Article numbers AE9796 XN-20 complete Analysis module Reagents for dilution* AJ37080 CELLPACK DST BQ CELLPACK DST Concentrated diluent (politainer) for preparation by RPU Concentrated diluent (politainer) for preparation by RPU 20 L 0 L CT66628 CELLPACK DCL Diluent (politainer) 20 L CU CELLPACK DCL Diluent (politainer) 0 L * Either CELLPACK DCL or CELLPACK DST is connected CP06675 Fluorocell WNR Reagents for XN-DIFF Labelling reagent (cartridge) to detect WBC and NRBC 82 ml AW AL Lysercell WDF CV Fluorocell WDF Reagents for XN-RET Surfactant (paper pack) to obtain the WBC differential Surfactant (politainer) to obtain the WBC differential Labelling reagent (cartridge) to obtain the WBC differential 4 L 5 L 42 ml BT96590 CELLPACK DFL BN Fluorocell RET Reagents for XN-PLT-F Surfactant (paper pack) to detect RET and PLT Labelling reagent (cartridge) to detect RET and PLT-O.5 L 2 ml BT96590 CELLPACK DFL CD Fluorocell PLT Surfactant (paper pack) to detect RET and PLT Labelling reagent (cartridge) to detect PLT-F.5 L 2 ml Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated: 26//205 - Page / 2

13 XN-20 Reagents for XN-WPC CS42800 Lysercell WPC BU Fluorocell WPC Quality control Surfactant (paper pack) to be used in the WPC channel Labelling reagent (cartridge) to be used in the WPC channel XN CHECK L XN CHECK L XN CHECK L XN CHECK BF L and L XN CAL Specifications Feature Number of diagnostic parameters* Research parameters Whole blood QC level for XN Whole blood QC level 2 for XN Whole blood QC level 3 for XN Body fluid QC level and 2 for XN Calibrator material Description Standard: CBC+DIFF: 28 Optional: RET: 7 PLT-F: 2 BF: 7 Standard: CBC+DIFF: 34 Optional: RET: 5 PLT-F: 2 BF:.5 L 2 ml 8 x 3 ml 8 x 3 ml 8 x 3 ml 3 x 3 ml 3 x 3 ml * For further details please refer to the Product Fact Sheets (PFS) on Added Values available on the Sysmex Extranet Sampling mode Aspiration volume Sampler mode Manual closed Manual open Pre-dilution mode Micro analysis Body fluid mode Required sample volume Whole blood mode: Sampler mode Manual closed Manual open Pre-dilution mode: Manual open Body fluid mode: Manual closed Manual open Operative temperature CBC+DIFF+RET+WPC Optionals (depending on the configuration): CBC+RET+PLT-F CBC+DIFF+RET+PLT-F CBC+DIFF+RET+PLT-F+WPC CBC+PLT-F CBC+DIFF+PLT-F Body fluid Standard: Whole blood mode Low WBC mode Pre-dilution (PD) mode Optional: Body fluid mode 88 µl 88 µl 88 µl 70 µl 88 µl (micro tube) 88 µl ml ml 300 µl (regular tube) 60 µl (micro tube) 300 µl (regular tube) 40 µl (micro tube) ml 300 µl (regular tube) 60 µl (micro tube) 5 C to 30 C Operative humidity 30 % to 85 % Power requirement AC 00 to 240 V (50/60 Hz) Power consumption 270 VA or less Feature Discrete mode profiles Description Standard: CBC (NRBC) CBC (NRBC)+DIFF CBC+RET CBC+DIFF+RET Reference: XN IFU EU 05 Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 26//205 by Melanie Steffens- Page 2 / 2

14 XN-000 Product Fact Sheet XN-000 Pure The new XN-IPU (Information Processing Unit) eases operations, fully monitors the analyser performance 24/7 through continuous remote service and supports the accreditation of labs by ensuring i.e. full reagent traceability. Productivity values The first step into full automation: excellent productivity per square metre Decreased TAT through potential reduction of smears by diagnostic applications Clinical values Product name Standard routine testing supports detection of inflammations or infections and therapy monitoring of infections by reliably counted nucleated red blood cells (NRBC) and immature granulocytes (IG) Using the optional RET application reliable diagnosis of anaemic patients based on the complete picture of the erythropoiesis by qualitative and quantitative information becomes standard and early prognosis of therapy monitoring can be realised by advanced clinical parameters and their combinations (e.g. RET- He, IRF) Availabilty of results of high precision in clinically relevant concentration ranges and support in detection of inflammatory processes (e.g.by WBC-BF count completed by PMN, MN) by using the optional BF mode XN-000 Pure Manufacture information Sysmex Corporation Summary The XN-000 Pure provides the full flexibility of profiles in haematology testing. It targets at laboratories with small to medium workloads where 00 samples/h are suitable. The measurement of routine haematology profiles includes already advanced clinical parameters like nucleated red blood cells (NRBC) and immature granulocytes (IG). Equipped with an additional application for reticulocyte measurement, the XN RET APP, reticulocyte haemoglobin equivalent gives a complete picture and early prognosis of the patient s erythropoesis by quality and quantity information. Configurations N o. Name Application Description XN-000 [DIFF] 2 XN-000 [RET] XN-0 unit with a non-reflex sampler for CBC+DIFF screening Optional BF mode XN-0 unit with a non-reflex sampler for CBC+DIFF screening + RET Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 07/0/205 by Claudia Dahmen - Page / 3

15 XN-000 Main components Optional BF mode AP CM66038 AL89824 XN-0 Unit for haematology haematology screening testing for the unit configuration,2 Non-reflex sampler for XN-000 XN-000 supply parts (SA-0) Pneumatic unit Sampler main unit to be connected with XN-0 IFU, cables, tubes etc. External pneumatic unit for XN instruments Monitor arm Monitor arm to connect the IPU touch screen XN IPU Instrument processing unit to operate the analyser XN touch panel Specifications Feature Diagnostics parameters (whole blood) Research parameters (whole blood) Description Touch screen for XN IPU Up to 36 depending on the configuration (refer to PFS_XN-0 ) Up to 42 depending on the configuration (refer to PFS_XN-0 ) Diagnostics Up to 7 depending on the configuration parameters (BF) (refer to PFS_XN added value BF ) Research Up to depending on the configuration parameters (BF) (refer to PFS_XN added value BF ) Scattergram & histogram Discrete mode profiles Up to 5 scattergrams Up to 4 histograms (refer to PFS_XN-0 ) Technologies Fluorescence flow cytometry Hydrodynamic focussed impedance measurement Light emitting diode (LED) photometry Adaptive cluster analysis system (ACAS) and special shape Throughput CBC CBC+DIFF CBC+DIFF+RET CBC+RET Body Fluid analysis recognition analysis of each WBC subpopulation Up to 00 samples/hour Up to 00 samples/hour Up to 83 samples/hour Up to 83 samples/hour Up to 40 samples/hour (BF modus only) Sampler unit 5 racks (50 samples) loading capacity STAT function Reagent management Data storage Analysis registration function Samples (incl. graphics) Patient information Wards registered Doctors names registered Selective test orders Quality control files Reagent replacement history Maintenance history Approx. min by using the manual mode Always available 2,000 records 00,000 results (including histograms and scattergrams) 0,000 records 200 wards 2,000 records 2 discrete profiles (depending on the configuration) 99 files 300 plots x 94 files (L-J control) 300 plots x 5 files (XbarM control) 5,000 records 5,000 records Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 07/0/205 by Claudia Dahmen - Page 2 / 3

16 XN-000 Dimension Main unit (incl. sampler unit) Pneumatic unit Weight Main unit (incl. sampler unit) Pneumatic unit QC functions Xbar and or L-J Xbar M Interface Operative temperature Operative humidity Power requirement Main unit Sampler Pneumatic unit Power consumption Main unit Sampler Pneumatic unit 520x 840x 680 mm (WxHxD) 280x400x355 mm (WxHxD) Approx. 70 kg Approx. 7 kg 300 plots x 94 files (L-J control) 300 plots x 5 files (XbarM control) LP, DP, GP, host computer via LAN 5 to 30 C 30 to 85 % AC 00 to 240 V (50/60 Hz) AC 00 to 240 V +/-0 % AC 220 to 240 V (50/60 Hz) 270 VA or less 0 VA or less 50 Hz: 230 VA or less (00-7 V), 220 VA or less ( V) 60 Hz: 280 VA or less (00-7 V), 250 VA or less ( V) Reference: XN-000 IFU 302 Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 07/0/205 by Claudia Dahmen - Page 3 / 3

17 XN-350 Standard clinical values Standard routine CBC and DIFF testing delivers a great range of clinically relevant parameters. The DIFF testing supports the detection of infections and provides guidance for diagnosis and therapy monitoring of infections by reliably counting immature granulocytes (IG). Optional clinical values Product name XN-350 Manufacturer information Using the optional RET application, reliable diagnosis of anaemic patients, based on the complete picture of the erythropoiesis by qualitative and quantitative information becomes standard. Early prognosis for therapy monitoring can be realised by advanced clinical parameters and their combinations (e.g. RET- He, IRF). In addition, the RET application provides improved PLT count reliability due to an automated switching algorithm in the case of interferences such as RBC fragments, microcytic RBC or giant PLT etc. Sysmex Corporation Summary The XN-350 is a member of the XN-L Series and part of the XN-Class. Encompassing Sysmex Silent Design, high levels of performance and operability and proven Sysmex technology, the XN-350 provides full flexibility of profiles in haematology testing. Optional productivity values Using the optional BF application, availability of results with high precision in clinically relevant concentration ranges and support in detection of inflammatory processes (e.g.by WBC-BF count completed by PMN, MN) by using the optional BF mode becomes standard. Main components BOM Item Description Qty Reliable analysis and accurate WBC counts including differentials for leucocytopenic samples in L-WBC measurement mode. SE XN-350 XN-350 main unit including items listed in the table below Decreased TAT by using the Speed-up application due to increased throughput from 60 to 70 samples/hour. The following items are included in the BOM: Article No. Item Description Qty AW68382 XN-350 XN-350 main unit (excl.supply parts) Handheld BR Gryphon Handheld barcode reader (excl. cable for Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 02/2/206 by SVCMOSS - Page / 3

18 XN CAB-426 CABLE XN/XT/XS/UF- 000I CE ZE ZE00067 ZE connection to instrument) Cable for connection of handheld barcode reader to instrument XN-350/450 Supply parts (for SUPPLY PARTS detailed content see (EU) IFU) Perixx Keyboard Additional keyboard PERIBOARD- for service 505H PLUS [US] (international keyboard) XN-L PRBC FLAG LICENCE XN-L INSTALLATION KIT Optional components XN-L licence to activate the irbc? Flag, which is mandatory on each XN-L analyser Installation kit (incl. ZE XN-L EMBEDDED SOFTWARE-IPU MEDIAKIT, ZE XN-L Labelling KIT) ZE ZE00054 ZE ZE ZE XN-L BF licence XN-L licence for the BF mode XN-L RET licence XN-L L-WBC licence XN-L Speed-up licence AGED SAMPLE IDENTIFIER PU-7 COMPLETE 200V(white) ZE00032 VS933AV Extended IPU Media kit Extended IPU server hardware Standard XN-L licence for the RET channel XN-L licence for the low WBC mode XN-L licence for higher throughput XN-L software ASI Package, includes: ASI certificate, 3 APP stickers and a fixing template to place the stickers properly on the analyser Additional pneumatic unit for use at high altitude SW to interlink all Sysmex workplaces to improve sample and data workflow Computer hardware for the Extended IPU server XL50AV Extended IPU Computer hardware XN375ATAB B SE ZE client hardware Extended IPU TFT monitor Ext. IPU SQLSV 202 STD RT LIC 5 CAL Handheld BR GRYPHON Cordless complete Gryphon Desk- /Wall Holder AK ZE CM9547 Reagents Intake Tube ASSY NO. 2 Spout Kit FOR 5L POLITAINER Intake Tube ASSY NO. 70 for an Extended IPU client TFT monitor for Extended IPU server and client hardware SQL Server Licence for Extended IPU; CAL licence package including licences for 5 CALs Handheld cordless barcode reader as alternative for Wall holder for handheld barcode reader For connecting 20 L CELLPACK DCL (politainer) For connecting 5 L Sulfolyser (politainer) and 5L Lysercell WDF (politainer) For connecting 4 L Lysercell WDF (paper pack) and.5 L CELLPACK DFL (paper pack) Article no. Item Qty CU CELLPACK DCL 0 L SULFOLYSER x 500 ml SULFOLYSER 3 x 500 ml BG LYSERCELL WDF x 2 L AA FLUOROCELL WDF 2 x 22 ml CELLCLEAN x 50 ml CF CELLCLEAN AUTO 20 x 4 ml AR CELLPACK DFL x L CU92020 FLUOROCELL RET 2 x 2 ml Quality control and calibration Article no. Item Qty XN-L CHECK L 6 x 3 ml 2357 XN-L CHECK L2 6 x 3 ml XN-L CHECK L3 6 x 3 ml Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 02/2/206 by SVCMOSS - Page 2 / 3

19 XN XN Check L 8 x 3 ml XN Check L2 8 x 3 ml XN Check L3 8 x 3 ml 2350 XN Check BF 2 levels 3 x 3 ml XN CAL 3 x 3 ml ZE USB STICK XN-L CHECK ZE USB STICK XN Check/XN Check BF ZE USB STICK XN CAL Specifications Feature Description Standard parameters 28 Standard diagnostic parameters Optional parameters WBC, RBC, HGB, HCT, MCHC, MCH, MCV, PLT, RDW-SD, RDW-CV, MPV, PDW, P-LCR, PCT, MicroR, MacroR NEUT%, MONO%, EO%, BASO%, LYMPH%, IG%, NEUT#, MONO#, EO#, BASO#, LYMPH#, IG# 8 Optional diagnostic parameters RET%, RET#, IRF, LFR, MFR, HFR, RET-He, Delta-He, RBC- He, HYPO-He, and HYPER-He WBC-BF, RBC-BF, PMN%, PMN#, MN%, MN#, TC-BF# Research parameters 3 Research parameters TNC, TNC-C, TNC-D, WBC- C, WBC-D, NE-SSC, NE-SFL, NE- FSC, NRBC #, NRBC %, HFLC#, HFLC% FRC#, FRC%, RPI, RBC-O, HGB-O, MCHC-O, Delta-HGB, PLT-O HF-BF#, HF-BF%, NE-BF#, NE-BF%, LY-BF#, LY-BF%, MO- BF#, MO-BF%, EO-BF#, EO-BF%, RBC-BF-2 Technologies Fluorescence flow cytometry Hydrodynamic focused Throughput CBC CBC+DIFF CBC+RET CBC+DIFF+RET Body Fluid (BF) analysis Aspiration volume Manual mode Low WBC mode Pre-dilution mode Body fluid mode Data storage Samples (incl. graphics) Patient information Wards registered Doctors names registered Calibration log Quality control files Analysis registration function Reagent replacement history Maintenance history QC functions Xbar and or L-J XbarM Weight Dimensions Interface impedance measurement SLS Haemoglobin method Up to 60 (70 * ) samples/hour Up to 60 (70 * ) samples/hour Up to 35 samples/hour Up to 35 samples/hour Up to 30 samples/hour (BF mode only) With optional Speed-up Licence 25 µl 25 µl 70 µl 70 µl 00,000 (including histograms and scattergrams) 0, wards 200 names 20 records 99 files (300 plots per file) 2,000 records 5,000 records 5,000 records 300 plots x 96 files (L-J control) 300 plots x 3 files (XbarM control) Approx. 35 kg Approx. 450 (W) x Approx. 460 (D) x Approx. 50 (H) mm RS-232C, Ethernet (RJ45), 4x USB Operating system Embedded Microsoft Windows 7 with McAfee Security Operative temperature 5 to 35 C Operative humidity 20 to 85 % Noise level Power requirement Power consumption 60dB or less AC 00 to 240 V (50/60 Hz) 235 VA Reference: XN-L BO, GI & TS IFU 606 Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 02/2/206 by SVCMOSS - Page 3 / 3

20 XN-450 Standard clinical values Standard routine CBC and DIFF testing delivers a great range of clinically relevant parameters. The DIFF testing supports the detection of infections and provides guidance for diagnosis and therapy monitoring of infections by reliably counting immature granulocytes (IG). Optional clinical values Product name XN-450 Manufacturer information Sysmex Corporation Summary The XN-450 is a member of the XN-L Series and part of the XN-Class. Encompassing Sysmex Silent Design, high levels of performance and operability and proven Sysmex technology, the XN-450 provides full flexibility of profiles in haematology testing. Using the optional RET application, reliable diagnosis of anaemic patients, based on the complete picture of the erythropoiesis by qualitative and quantitative information becomes standard. Early prognosis for therapy monitoring can be realised by advanced clinical parameters and their combinations (e.g. RET- He, IRF). In addition, the RET application provides improved PLT count reliability due to an automated switching algorithm in the case of interferences such as RBC fragments, microcytic RBC or giant PLT etc. Using the optional BF application, availability of results with high precision in clinically relevant concentration ranges and support in detection of inflammatory processes (e.g.by WBC-BF count completed by PMN, MN) by using the optional BF mode becomes standard. Optional productivity values Reliable analysis and accurate WBC counts including differentials for leucocytopenic samples in L-WBC measurement mode. Main components BOM No. Item Description Qty SE00062 XN-450 XN-450 main unit including items listed in the table below Decreased TAT by using the Speed-up application due to increased throughput from 60 to 70 samples/hour. The following items are included in the BOM: Article No. Item Description Qty BM XN-450 XN-450 main unit (excl. supply parts) Handheld BR Gryphon Handheld barcode reader (excl. cable for Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 02/2/206 by SVCMOSS - Page / 3

21 XN CAB-426 CABLE XN/XT/XS/UF- 000I CE ZE ZE00067 ZE connection to instrument) Cable for connection of handheld barcode reader to instrument XN-350/450 Supply parts (for SUPPLY PARTS detailed content see (EU) IFU) Perixx Keyboard Additional keyboard PERIBOARD- for service 505H PLUS [US] (international keyboard) XN-L PRBC FLAG LICENCE XN-L INSTALLATION KIT Optional Components XN-L licence to activate the irbc? Flag, which is mandatory on each XN-L analyser Installation kit (incl. ZE XN-L EMBEDDED SOFTWARE-IPU MEDIAKIT, ZE XN-L Labelling KIT) ZE ZE00054 ZE ZE ZE XN-L BF licence XN-L licence for the BF mode XN-L RET licence XN-L L-WBC licence XN-L Speed-up licence AGED SAMPLE IDENTIFIER PU-7 COMPLETE 200V(white) ZE00032 VS933AV Extended IPU Media kit Extended IPU server hardware Standard XN-L licence for the RET channel XN-L licence for the low WBC mode XN-L licence for higher throughput XN-L software ASI Package, includes: ASI certificate, 3 APP stickers and a fixing template to place the stickers properly on the analyser Additional pneumatic unit for use at high altitude SW to interlink all Sysmex workplaces to improve sample and data workflow Computer hardware for the Extended IPU server XL50AV Extended IPU Computer hardware XN375ATAB B SE ZE client hardware Extended IPU TFT monitor Ext. IPU SQLSV 202 STD RT LIC 5 CAL Handheld BR GRYPHON Cordless complete Gryphon Desk- /Wall Holder AK ZE CM9547 Reagents Intake Tube ASSY NO. 2 Spout Kit FOR 5L POLITAINER Intake Tube ASSY NO. 70 for an Extended IPU client TFT monitor for Extended IPU server and client hardware SQL Server Licence for Extended IPU; CAL licence package including licences for 5 CALs Handheld cordless barcode reader as alternative for Wall holder for handheld barcode reader For connecting 20 L CELLPACK DCL (politainer) For connecting 5 L Sulfolyser (politainer) and 5 L Lysercell WDF (politainer) For connecting 4 L Lysercell WDF (paper pack) and.5 L CELLPACK DFL (paper pack) Article no. Item Qty CU CELLPACK DCL 0 L SULFOLYSER x 500 ml SULFOLYSER 3 x 500 ml BG LYSERCELL WDF x 2 L AA FLUOROCELL WDF 2 x 2 ml CELLCLEAN x 50 ml CF CELLCLEAN AUTO 20 x 4 ml AR CELLPACK DFL x L CU92020 FLUOROCELL RET 2 x 2 ml Quality control and calibration Article no. Item Qty XN-L CHECK L 6 x 3 ml 2357 XN-L CHECK L2 6 x 3 ml XN-L CHECK L3 6 x 3 ml Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 02/2/206 by SVCMOSS - Page 2 / 3

22 XN XN Check L 8 x 3 ml XN Check L2 8 x 3 ml XN Check L3 8 x 3 ml 2350 XN Check BF 2 levels 3 x 3 ml XN CAL 3 x 3 ml ZE USB STICK XN-L CHECK ZE USB STICK XN Check/XN Check BF ZE USB STICK XN CAL Specifications Feature Standard parameters (whole blood) Optional parameters Description 28 Standard diagnostic parameters WBC, RBC, HGB, HCT, MCHC, MCH, MCV, PLT, RDW-SD, RDW-CV, MPV, PDW, P-LCR, PCT, MicroR, MacroR NEUT%, MONO%, EO%, BASO%, LYMPH%, IG%, NEUT#, MONO#, EO#, BASO#, LYMPH#, IG# 8 Optional diagnostic parameters RET%, RET#, IRF, LFR, MFR, HFR, RET-He, Delta-He, RBC- He, HYPO-He, and HYPER-He WBC-BF, RBC-BF, PMN%, PMN#, MN%, MN#, TC-BF# Research parameters 3 Research parameters TNC, TNC-C, TNC-D, WBC- C, WBC-D, NE-SSC, NE-SFL, NE- FSC, NRBC #, NRBC %, HFLC#, HFLC% FRC#, FRC%, RPI, RBC-O, HGB-O, MCHC-O, Delta-HGB, PLT-O HF-BF#, HF-BF%, NE-BF#, NE-BF%, LY-BF#, LY-BF%, MO- BF#, MO-BF%, EO-BF#, EO-BF%, RBC-BF-2 Technologies Fluorescence flow cytometry Hydrodynamic focused Throughput CBC CBC+DIFF CBC+RET CBC+DIFF+RET Body Fluid (BF) analysis Aspiration volume Manual mode Low WBC mode Pre-dilution mode Body fluid mode Data storage Samples (incl. graphics) Patient information Wards registered Doctors names registered Calibration log Quality control files Analysis registration function Reagent replacement history Maintenance history QC functions Xbar and or L-J XbarM Weight Dimensions Interface impedance measurement SLS Haemoglobin method Up to 60 (70 * ) samples/hour Up to 60 (70 * ) samples/hour Up to 35 samples/hour Up to 35 samples/hour Up to 30 samples/hour (BF mode only) With optional Speed-up Licence 25 µl 25 µl 70 µl 70 µl 00,000 (including histograms and scattergrams) 0, wards 200 names 20 records 99 files (300 plots per file) 2,000 records 5,000 records 5,000 records 300 plots x 96 files (L-J control) 300 plots x 3 files (XbarM control) Approx. 35 kg Approx. 450 (W) x Approx. 460 (D) x Approx. 440 (H) mm RS-232C, Ethernet (RJ45), 4x USB Operating system Embedded Microsoft Windows 7 with McAfee Security Operative temperature 5 to 35 C Operative humidity 20 to 85 % Noise level Power requirement Power consumption 60dB or less AC 00 to 240 V (50/60 Hz) 235 VA Reference: XN-L BO, GI & TS IFU 606 Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 02/2/206 by SVCMOSS - Page 3 / 3

23 XN-550 Optional productivity values Reliable analysis and accurate WBC counts including differentials for leucocytopenic samples in L-WBC measurement mode. Decreased TAT by using the Speed-up application due to increased throughput from 60 to 70 samples/hour. Standard clinical values Product name XN-550 Manufacturer information Standard routine CBC and DIFF testing delivers a great range of clinically relevant parameters. The DIFF testing supports the detection of infections and provides guidance for diagnosis and therapy monitoring of infections by reliably counting immature granulocytes (IG). Sysmex Corporation Optional clinical values Summary The XN-550 is a member of the XN-L Series and part of the XN-Class. Encompassing Sysmex Silent Design, high levels of performance and operability and proven Sysmex technology, the XN-550 provides full flexibility of profiles in haematology testing. Additionally, the built-in Rerun & Reflex and Intelligent Rack Sampling functionalities provide a more streamlined workflow and a decrease in the sample turnaround time. Using the optional RET application, reliable diagnosis of anaemic patients, based on the complete picture of the erythropoiesis by qualitative and quantitative information becomes standard. Early prognosis for therapy monitoring can be realised by advanced clinical parameters and their combinations (e.g. RET- He, IRF). In addition, the RET application provides improved PLT count reliability due to an automated switching algorithm in the case of interferences such as RBC fragments, microcytic RBC or giant PLT etc. Standard productivity values Superb performance and decreased TAT through an integrated IPU rule set for automated Rerun and Reflex testing Using the optional BF application, availability of results with high precision in clinically relevant concentration ranges and support in detection of inflammatory processes (e.g.by WBC-BF count completed by PMN, MN) by using the optional BF mode becomes standard. Decreased TAT through automatic measurement of raised bottom tubes (RBT) by Intelligent Rack Sampling. Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 02/2/206 by SVCMOSS - Page / 4

24 XN-550 Main components BOM No. Item Description Qty SE XN-550 XN-550 main unit including items listed in the table below The following items are included in the BOM: BD XN-550 XN-550 main unit with 2 sampler adapter with the capacity of 0 samples each. (excl. supply parts) Handheld BR Gryphon CAB-426 CABLE XN/XT/XS/UF- 000I AH72969 ZE ZE00067 ZE Handheld barcode reader (excl. cable for connection to instrument) Cable for connection of handheld barcode reader to instrument XN-550 Supply parts (for SUPPLY PARTS detailed content see (EU) IFU) Perixx Keyboard Additional keyboard PERIBOARD- for service 505H PLUS [US] (international keyboard) XN-L PRBC FLAG LICENCE XN-L INSTALLATION KIT Optional Components XN-L licence to activate the irbc? Flag, which is mandatory on each XN-L analyser Installation kit (incl. ZE XN-L EMBEDDED SOFTWARE-IPU MEDIAKIT, ZE XN-L Labelling KIT) ZE ZE00054 ZE XN-L BF licence XN-L RET licence XN-L L-WBC licence XN-L licence for the BF mode XN-L licence for the RET channel XN-L licence for the low WBC mode ZE XN-L Speed-up XN-L licence for ZE ZE00032 VS933AV XL50AV XN375ATABB SE ZE AK ZE CM9547 Reagents licence AGED SAMPLE IDENTIFIER PU-7 COMPLETE 200V(white) Media kit Extended IPU Extended IPU server hardware Extended IPU client hardware Extended IPU TFT monitor Ext. IPU SQLSV 202 STD RT LIC 5 CAL Handheld BR GRYPHON Cordless complete Gryphon Desk- /Wall Holder Intake Tube ASSY NO. 2 Spout Kit FOR 5L POLITAINER Intake Tube ASSY NO. 70 higher throughput XN-L software ASI Package, includes: ASI certificate, 3 APP stickers and a fixing template to place the stickers properly on the analyser Additional pneumatic unit for use at high altitude SW to interlink all Sysmex workplaces to improve sample and data workflow Computer hardware for the Extended IPU server Computer hardware for an Extended IPU client TFT monitor for Extended IPU server and client hardware SQL Server Licence for Extended IPU; CAL licence package including licences for 5 CALs Handheld cordless barcode reader as alternative for Wall holder for handheld barcode reader For connecting 20 L CELLPACK DCL (politainer) For connecting 5 L Sulfolyser (politainer) and 5 L Lysercell WDF (politainer) For connecting 4 L Lysercell WDF (paper pack) and.5 L CELLPACK DFL (paper pack) Article no. Item Qty CU CELLPACK DCL 0 L Bornbarch, Norderstedt, Germany Phone Fax info@sysmex-europe.com Last updated on 02/2/206 by SVCMOSS - Page 2 / 4