Firma:              Sysmex

Modell:            SE 9500

Kommentar:   Dokumente engl. (für ID. 13860)

INTRODUCTION

The Sysmex© SE-9500 is a technically advanced, computerized, fully automated hematology analyzer with many features, for in vitro diagnostic use in clinical laboratories. The SE-9500 provides accurate screening for patients whose hematologic abnormalities indicate the need for further testing. In addition, it can contribute to diagnosis, patient monitoring and judgment of treatment effectiveness.

The SE-9500 has the capability of analyzing up to 120 samples per hour, and displays 6 different types of data patterns -- WBC 3 differential, immature cell scattergrams, and cell size distribution curves for eosinophils, basophils, red blood cells and thrombocytes, as well as 23 analysis data parameters on the DMS (data management system) screen.

Chapter 1 is an introduction to this manual, major system components, system operation and other general considerations. This chapter should be read before operating the SE-9500. Chapter 1 contains the following subjects:

Manual Organization

A description of the Operator's Manual and explanation of important informational headings.

System Overview

An introduction to the main elements of the SE-9500 analyzer, including a description of the options available to enhance the instrument's operation.

Safety Summary

Covers major safety considerations when using and servicing the SE-9500.

Operational Summary

A summary of the operating procedures for each mode, the DMS screen display, names and functions of keyboard keys, etc.

Installation

Includes space requirements, necessary equipment, installation environment and other essential information to be reviewed before installation of the SE-9500.

Instrument Specifications

The instrument's specifications are given in a reference table.

SYSTEM OVERVIEW

The purpose of the SE-9500 is to provide accurate results an 23 parameters and to detect samples that present an abnormality. To assist the laboratory in the screening of abnormals, the SE-9500 analyzes and processes the data obtained from the analyzer unit, and the DMS displays and prints either a POSITIVE or a NEGATIVE message for each sample. A NEGATIVE message signifies that parameter values for the sample are within acceptable limits and the sample does not require any additional verification of those values. A POSITIVE message signifies that the sample is not within the acceptable limits and requires further review and investigation. Proper use of the instrument requires laboratory to establish the acceptable limits for results.

The SE-9500 uses four detector blocks and four types of reagent to analyze the WBC populations. In the DIFF detector block, lymphocyte, granulocyte and monocyte cells are treated with diluent and lyse reagents are analyzed using the Radio Frequency (RF) and Direct Current (DC) detection methods. The WBC detector block uses a mixture of diluent and lyse reagents and the DC detection method to determine the number of WBCs. Eosinophil and Basophil determinations are performed by the EO and BASO detector blocks respectively, using the DC detection method and a cell-specific lysing reagents. RBCs and PLTs are analyzed by the RBC detector block using the sheath-flow DC detection method. HGB determination is performed using the SLS hemoglobin (or Cyanmethemoglobin) detection method. Also, the immature cell information is determined qualitatively by the IMI detector block using the RF­DC detection method.

The SE-9500 consists of five major systems.

• Main Unit                      Houses the hydraulic and electronic system for analysis and their          control components.

• Sampler Unit                Consists of a mixer, cap piercer unit which supplies samples to the       Main Unit.

• DMS                             Processes and displays data obtained from the Main Unit.

• Pneumatic Unit            Supplies the required pressure and vacuum for analysis.

• Power Supply Unit       Supplies power to the Main Unit.

Sysmex SE-9500 Hematology Analyzer

System Specifications

Parameters                             WBC, NEUT%, LYMPH%, MONO%, EO%, BASO%,         NEUT#, LYMPH#, MONO#, EO#, BASO#, RBC, HGB, HCT,       MCV, MCH, MCHC, RDW-SD, RDW-CV, PLT, PDW, MPV, P-      LCR

Throughput                              Approximately 120 samples per hour

                                               (CBC + Diff: Approx. 120 seconds per sample. CBC:        Approx. 70 seconds per sample)

Principles                                RF/DC Detection Method (MONO, GRAN, IMI)

                                               DC Detection Method (WBC, LYMPH, EO, BASO)

                                               Sheath-Flow DC Detection Method (RBC, PLT)

                                               SLS Hemoglobin Method or Cyanmethemoglobin Method (HGB)

                                               Cumulative Pulse Height Detection Method (HCT)

                                               MCV (Calculated from RBC and HCT)

                                               MCH (Calculated from RBC and HGB)

                                               MCHC (Calculated from HCT and HGB)

                                               NEUT (Calculated from WBC, EO, BASO, LYMPH,           MONO)

Sample Volume Required       Sampler Mode               Approximately 250 µL

                                               Closed Mode                  Approximately 250 µL

                                               Manual Mode                  Approximately 100 µL

                                               Capillary Mode               Over 40 µL

Data Storage Capacity:           Cell size distribution data (with graphs): for 10,000 samples

                                               Scattergrams                 for 10,000 samples

                                               Patient information         for 5,000 patients

                                               Order information          for 1,000 samples

Dimensions                             Main Unit & Sampler Unit        Approx. 720 x 636 x 820

H x W x D (mm)                      Power Supply Unit      Approx. 215 x 285 x 325

                                               Pneumatic Unit           Approx. 390 x 340 x 500

                                               Data Management System (DMS)     Approx. 486 x 472 x 618

Power Requirement                117 VAC ± 10%, 220 VAC ± 10%, 240 VAC ± 10% (50 or 60          Hz)

Power Consumption               Power Supply Unit (Main & Sampler Unit):

                                               117 VAC, 50 Hz (or 60 Hz) 820 VA

                                               220 VAC, 50 Hz (or 60 Hz) 870 VA

                                               240 VAC, 50 Hz (or 60 Hz) 870 VA

                                               Pneumatic Unit:

                                               400 VA, 50 Hz (or 60 Hz)

                                               Data Management System: 600 VA, 50 Hz (or 60 Hz)

Temperature                           Approx. 1196 kcal/h (4743 BTU/h)

Compensation Required         (Excluding DMS and printers)

Protection Type                       I Class I equipment

RAM 1

Accurate

► more than 30.00 RBC's per cycle are analyzed: highest precision even at low reticulocyte ► concentrations allows monitroing of patient treatment and therapy.

► Optimum light source for particle analysis by high power argon laser

► Golden Standard technology for reticulocyte analysis

► Fixed volume: absolute counting eliminates need for system calibration

► QC material with IQAS support (International Quality Assurance System)

Innovative parameter

► Platelet (O) as verification option for PLT-count accuracy in extremely pathological samples.

► IRF parameter for monitoring patient treatment

Easy to operate

► Fully automated with autosampler

► Sample identification by barcode

► Review support by download of patient demographics from HOST computer

► Rapid patient oriented validation with cumulative data review display

Principle & Technologies

Flow Cytometry with argon laser

Two detection wavelengths

Cetl RNA/DNA stain:

Auramine-0 (Fluorochrome)

Parameters

RET %, RET#, RBC, LFR, MFR, HFR

Research Mode: PLT(0)

Throughput

72 -119 samples/h

Sample Volume

100 µl (manual mode)

250 µl (auto mode)

  40 µl (capillary mode)

Data Storage

10.000 samples, including scattergramns and histograms

Communication

Bi-directional

Quality Control

16 flies with 180 data-points

Interfaces

Serial: HOSE Computer, Line Printer

Parallel: Data- and Graphic Printer

Dimensions (WxDxH, mm)

Weights (kg)   Main Unit                      400x505X720/46

                        Laser Unit                    222X290X216/23

Power Supply Unit      221x285x148/8,7

Pneumatic Unit            222x290x216/16,5

Configurations

Requires operation connected

with AMS main unit (SE-9000/9500)