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XE-5000TM

Automated Hematology System

Introduction

Excellent Performance · Reliable platform · Low sample volume requirements (minimum 40 L whole blood) · SNCS ready to provide maximum uptime · Low maintenance (<1 min user hands-on time per day) · Ranked by third party as highest vendor for reliability for 8 consecutive years in a row* *IMV Service Trak 2007

Reportable, diagnostic information from a single sample analysis · 6-part whole blood WBC differential (NE + Lymph + Mono + Eo + Baso + IG) with fluorescent NRBC count · Body fluid cell count and differential · Quantitative hematopoietic progenitor cell count (HPC) · Anemia evaluation parameter (RET-He) · Thrombopoietic activity assessment parameters (IPF) Easy-to-use · Intuitive software menus · On-board help key for rapid troubleshooting · Comprehensive quality control information · Barcoded reagent management Designed to be scalable, reliable and efficient the Sysmex XE-5000TM offers the medium to high volume labs an automated hematology system that can truly meet and exceed their expectations. The XE-5000 streamlines your workflow by providing rapid testing for up to 150 samples per hour, enabling a quick turnaround time. The Sysmex XE-5000 Automated Hematology System utilizes the power of fluorescent flow cytometry and hydrodynamic focusing technologies. Using a unique state-of-the-art, diode laser bench, Sysmex fluorescent flow cytometry provides the sensitivity needed for measuring and differentiating cell types in whole blood and body fluid samples. Fluorescent technology and hydrodynamic focusing enable the XE-5000 to consistently classify normal WBC, RBC and PLT populations from abnormal populations, thereby decreasing the number of manual processes.

Clinically Relevant Information

By utilizing these technologies, the Sysmex XE-5000 is able to provide the following clinically relevant, reportable parameters: · NRBC ­ Fluorescent NRBC count with excellent sensitivity and specificity · PLT-O ­ Fluorescent optical platelet count and traditional impedance PLT counting to improve accuracy of very low and very high PLT counts · Retic ­ Fluorescent reticulocyte count to significantly reduce manual confirmation methods and their inherent errors

· HPC ­ Quantitative hematopoietic progenitor cell count as a screen for the optimal presence of hematopoietic progenitor cells in peripheral blood and cord blood samples · RET-He ­ Reticulocyte hemoglobin equivalent to assist in anemia evaluation and management (e.g., functional iron deficiency anemia) · IPF ­ Immature platelet fraction (measurement of reticulated platelets) to monitor thrombopoietic activity of the marrow · IG ­ Immature granulocyte count to provide an automated, quantitative measure of immature WBCs Fluorescent Nucleated Red Blood Cells (NRBC%, #) are enumerated in a dedicated channel on the XE-5000. The NRBC parameter · Offers improved sensitivity · Provides rapid information for clinicians to assist in patient diagnosis and treatment decisions · Gives an automated correction of WBC and Diff results, resulting in less technical intervention and fewer errors due to manual calculations · Decreases false negative and false positive rates with better separation from WBCs and RBCs · Can be available with every CBC, providing more information to clinicians for prompt diagnosis and treatment Fluorescent Optical Platelet (PLT-O) is a complementary, reportable parameter to the impedance platelet count. The PLTO parameter · Offers improved accuracy on low platelet counts · Provides accurate counts when interferences are present and reduces manual intervention · Allows automated judgment for reporting PLT-O or impedance PLT through instrument settings, eliminating tech-to-tech decision variability

Advanced Parameters

Immature Platelet Fraction (IPF%) is a parameter used to assess thrombopoiesis. This parameter · Offers result accuracy and sensitivity · Assists clinicians with differentiation of platelet destruction or consumption seen in certain diseases like AITP (autoimmune thrombocytopenic purpura) and TTP (thrombotic thrombocytopenic purpura) · Provides rapid analysis for prompt clinical information that can potentially avoid invasive and costly procedures Fluorescent Reticulocyte Count Known as the "Gold Standard" reticulocyte testing parameter, the fluorescent reticulocyte count is available on the XE-5000. Sysmex was one of the first companies to provide on-board retic testing in a dedicated channel, which improved efficiencies in reticulocyte counting. With the use of fluorescent technology, the Retic count · Gives improved immature reticulocyte information for earlier diagnosis and treatment by clinicians · Eliminates common interferences from Howell-Jolly bodies, Pappenheimer bodies and immature reticulocytes to avoid manual counts Reticulocyte Hemoglobin Equivalent (RET-He) is a parameter used to measure information on the hemoglobin content of immature reticulocytes. The RET-He parameter · Provides rapid analysis and information at an earlier stage of RBC development for prompt clinical follow-up · Is used in the assessment of anemia and is an established parameter used in KDOQI (Kidney Disease Outcomes Quality Initiative) guidelines for assessing the initial iron status of patients · Offers result accuracy and sensitivity which helps to avoid costs associated with unnecessary drug treatment Hematopoietic Progenitor Cell Counts The Sysmex automated HPC count is substantially equivalent to CFU and CD34+. The HPC count · Provides quality screening information to better assist clinician with patient treatment course

· Does not require additional reagents, sample volume or specific technical expertise, which reduces costs · Automates manual processes · Offers a rapid analysis versus conventional methods, thereby allowing for a prompt determination of optimal stem cell harvest time Immature Granulocyte Count (IG%, #) offers reportable, quantitative results for immature granulocytes (metamyelocytes, myelocytes and promyelocytes). The IG count · Offers result accuracy and sensitivity by reducing false positive and false negative rates and labor associated with manual smear review · Gives an automated count which improves accuracy and result consistency by reducing tech-to-tech variations in reporting manual differentials · Provides rapid analysis for improved turnaround time (TAT) when compared to manual differential counting

Improved Productivity & Efficiency

XE-5000 Body Fluid Mode: The XE-5000 analyzer includes a body fluid specific mode. This provides a reportable WBC, RBC, differential (polymorphonuclear and mononuclear) and a total count (TC-BF) for all common body fluid samples (CSF, synovial and serous). The analyzer applies proven fluorescent flow cytometry technology and performs an automatic background check to produce accurate counts from a single sample analysis. No sample pre-treatment, reagents or additional quality control material are needed. WBC and RBC counts are reportable to 3-decimal places, providing expanded sensitivity and linearity. The XE-5000 body fluid count and differential improve productivity and result turnaround time (TAT) and decreases manual technical intervention. SNCS The XE-5000 has SNCS (Sysmex Network Communications System), which helps your laboratory achieve maximum productivity. Linked to Sysmex Technical Assistance Center (TAC), SNCS is a remote management system that regularly and securely collects and monitors performance data from your Sysmex instrument (in this case, the XE-5000). SNCS provides quick proactive response to potential problems, reducing the number of unscheduled service calls and maximizing your system uptime. Improved Patient Care Sysmex analyzers, along with the XE-5000, include a capillary mode (pre-dilute analysis mode) which requires micro sample volume of 40L to provide quality clinical data, rapidly and consistently. The XE-5000 capillary mode can also provide the most comprehensive clinical results which includes CBC, 6-part differential, retic and NRBC. Productivity The system provides a throughput of up to 150 samples per hour, producing high quality results rapidly for clinicians to use in diagnosing and treatment decisions · The system is compatible with Sysmex automation platforms, providing solutions that can be scalable to meet needs of all laboratories · XE-5000 can also be used in conjunction with Sysmex MOLIS TM WAM , a rules-based hematology information system, which enhances sample and data workflow and improves turnaround time (TAT) The XE-5000 offers a comprehensive clinical testing menu for both whole blood and body fluids, providing accurate, precise and sensitive results. With its rapid throughput, your clinicians receive quality results to assist in management and diagnosis of diseases.

Principles & Technologies

Fluorescent Flow Cytometry: WBC-Diff, IG, NRBC, RET, IRF, PLT-O RF-DC method: HPC C-sheath-flow: PLT, RBC, HCT SLS-method: Hgb WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (Impedance and Fluorescent Optical) NEUT%, LYMPH%, MONO%, EO%, BASO%, NRBC%, NEUT#, LYMPH#, MONO#, EO#,

31 Whole Blood Reportable Parameters

BASO#, NRBC#, IG%, IG#, HPC#, RDW-SD, RDW-CV, MPV, RET%, RET#, IRF, RET-He, IPF

7 Body Fluid Reportable Parameters Throughput

WBC-BF, RBC-BF, MN%, MN#, PMN%, PMN# TC-BF# Whole Blood Mode 150 samples/h (max.) Body Fluid Mode 38 samples/h (max.) 200L / 130l (closed / open mode) 40L for capillary mode 10,000 samples (incl. graphics)

Sample Volumes Data Storage

(IPU: Information Processing Unit)

Quality Control

(Total QC Management)

Comprehensive QC files including "current" and "new" lot feature X-bar M file Online QC ASTM TM MOLIS WAM (HL7 & ASTM) 27.8 x 35.9 x 28 / 178 Sampler: 22.8 x 14.8 x 7.7 / 26 IPU: 18 x 17.6 x 5.3 / 24 Stand alone Sysmex HST-N, AlphaN Automation

Interfaces Dimensions / Weight Main unit:

wxhxd [in] / [lbs]

Configurations

Information

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