Firma:              Beckman

Modell:            GenS

Kommentar:    Dokumente engl.

INTENDED USE

The COULTER® GEN • STM System, Figure 1.1, is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The GEN•S System provides automated complete blood count, leukocyte differential and Reticulocyte analysis.

The purpose of the GEN•S System is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, biochemical investigations, manual WBC differential or any other definitive test that helps diagnose the patient's condition.

PHYSICAL SPECIFICATIONS

Dimensions

Unit                                         Height*                Width*                  Depth*                 Weight

Analyzer                                  35.6 cm                99.1 cm                38.1 cm                49.9 k

                                               (14 in.)                  (39 in.)                  (15 in.)                  (110 Ib)

Diluter                                      50.8 cm                99.1 cm                55.9 cm                54.4 k

                                               (20 in.)                  (39 in.)                  (22 in.)                  (120 Ib)

Power                                      63.5 cm                38.1 cm                66.0 cm                56.7 k

Supply                                     (25 in.)                  (15 in.)                  (26 in.)                  (125 Ib)
* ±5.1 cm (2 in.)

Power

Input

Power Supply:                         90 - 264 Vac, 47 - 63 Hz

Workstation:                            90-135 Vac, 47-63 Hz or 180-265 Vac, 47-63 Hz

Consumption

1650 W (5500 BTU/h) maximum

Installation Category: per IEC 1010-1, Category II

Temperature

Ambient operating range for patient samples: 15.5 to 32°C (60 to 90°F)

Humidity

0 to 95% without condensation

Sample Stability

CBC/Diff Parameters

• Stored at room temperature, up to 24 hours after collection

• Stored between 2 and 8°C (35.6 and 46.4°F), up to 48 hours

  after collection

Reticulocyte Parameters

• Stored at room temperature (23.9°C or 75°F), up to 24 hours

  after collection

• Stored between 2 and 8°C (35.6 and 46.4°F), up to 72 hours

  after collection

Sample Storage

Room temperature (23.9°C, 75°F) up to 24 hours

Sample Type

Anticoagulated human whole blood

Recommended Anticoagulant

  K2EDTA or K3EDTA

COULTER ^® Gen-S Hematology Analyzer

The Beckman-Coulter GEN-S, a new generation hematology analyzer capable of providing a complete blood count, a five-part differential leukocyte count, and a reticulocyte count.

The Gen-S provides automated reticulocyte counts from closed vial sample aspiration to result transmission, and permits you to enjoy significant productivity gains. Compared to manual methods, each automated count saves up to 10 minutes of valuable operator time.

In addition, automated counts give you the assurance of greater accuracy.

The Gen-S represents a new generation fully automated hematology analyzer that can provide the laboratory with up to 34 blood count parameters: a complete blood count (CBC), a five-part differential leukocyte count (DLC), a complete reticulocyte count, and an automated CD4/CD8 count. Moreover, when abnormal leukocytes are present, the system generates different flags.

System Description

The Gen-S analyzer uses the Coulter Volume, Conductivity, Scatter (VCS) technology to probe hydrodynamically focused cells. Volume measurement is performed using the Coulter principle of electrical impedance. The high frequency conductivity provides information about cell size, internal structure, and density. A helium-neon laser and a multiple-angle light scatter provide information about a cell's internal structure, granularity, and surface morphology. VCS technology has proven effective on the Coulter STKS and MAXM analyzers. The GEN-S refines this technology through the use of the IntelliKinetic (Beckman trademark technology) application. This hardware and software system intelligently manages variations in the ambient laboratory temperature through automatic adjustments of reagent reaction temperature, exposure time, and delivery volumes.

Enhancement in instrument electronics works with the IntelliKinetic application to provide better data signals for the system algorithm to analyze. Collected data are analyzed by Coulter AccuGate software (version EASE 2, (Beckman trademark technology)), which contains adaptive statistical tools that assist in delineating overlapping populations including new suspect flags

(e.g., Ly blast for Lymphoblast suspect) and additional "research use only" parameters. DLC data can be presented in a multidimensional format.

·        A limited grouping of just four reagent packs that handle all your routine hematology testing needs

·        Three independent counts for WBC, RBC and Plt

·        Extended counting for cytopenic samples

·        Pulse editing technology for accurate cell volumes

·        High resolution histograms using 256 channels

·        Log-fitting platelet algorithm eliminates RBC interference

·        Sweep flow technology prevents recirculating red cells and improves platelet accuracy

·        Radio frequency (RF) energy penetrates the cell, information is gathered about the cell size and internal structure

Slidemaker GENS SM ^TM

The COULTER GEN S SM ^TM SlideMaker is intended for use as an optional peripheral to the COULTER GEN S ^TM System. The Slide maker creates a blood smear on a clean microscope slide using a segment of the blood sample aspirated by the GEN S System.

Physical Specifications

(See the GEN S System specifications for general specifictions that apply to both the GEN S System and the SlideMaker.)

Specification that apply only to the SlideMaker are listed here:

Dimensions:

Height:            45,7 cm (18in)

Width:                         61,0 cm (27in)

Depth:             61,0 cm (24in)

Weight:           45,8 kg (100lb)

Power:

Input:               90-264 Vac

                        48-62 Hz

Consumption: 350 W (Btu) maximum

Recommended Reagents

The GEN S SM SlideMaker uses the diluent and cleaning agent from the GEN S System:

▪ ISOTON®III diluent

▪ COULTER CLENZ® celaning agent

Sample Volume

Aspirated Volume:       250 µL maximum

Dispensed Volume:    4µL ±0,5 L

Slidestainer GenS ST ^TM

Working in conjunction with the GENS and GEN•S SMTM SlideMaker, the GENS STTM SlideStainer is a programmable laboratory device that is capable of delivering a variety of fixatives, stains, buffers and rinse solutions to whole blood films prepared on glass microscope slides. The flexibility of the GEN•S SlideStainer allows for the adaptation of a large range of currently popular stain methodologies depending upon the preferences of the user.

The GEN•S SlideStainer contains five baths with automatic reagent refill capabilities and a sixth warm air bath for the drying of the stained film following the staining process. Blood films produced by the GEN•S SlideMaker and contained in metal carriers are automatically transferred to the GEN•S SlideStainer by a robotic arm to the fixative, staining, buffer, rinse and drying positions at programmable intervals. Following the drying sequence the slide filled carriers are removed to a location on the stainer to await removal by the laboratorian

The stained whole blood film produced by the GENS SlideStainer, when inspected microscopically, can be used to help determine the hematological status of a patient. A stained blood film, in addition to allowing for the differentiation of white cells, facilitates the characterization of red cells and platelets as well as the identification of blood component anomalies.

Dimensions:

Height:            48.26 cm (19in.)

Width:                         58.42 cm (23in.)

Depth:             71.2 cm (28in.)