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BN II System

Confidence in plasma protein results

 

 BN II System

    The BN™ II System is an easy-to-use, reliable nephelometric analyzer that offers a broad range of protein assays. With assays available across multiple sample types, you can conveniently assess numerous disease states such as gammopathies, kidney diseases, neurology, and chronic alcohol abuse—on just one system.

    • Designed for mid- to high-volume plasma protein throughput
    • Broad menu from one source; more than 60 assay protocols available for determination of various sample types
    • Up to 100 samples onboard
    • Antigen-excess security for confidence in results
    • Connectivity options to Aptio® Automation and FlexLab Automation solutions
    • Assistance with clinical interpretation through our innovative range of assessment programs available for Protis® IT Solution1

    Features & Benefits

    As the first dedicated protein analyzer that can be connected to lab automation, the BN™ II System provides flexible options to meet the needs of the mid- to high-volume plasma protein lab. It uses nephelometric technology for protein determination and supports the clinical management of a variety of disease states, such as gammopathies, kidney diseases, neurology, and chronic alcohol abuse.

    Increased workflow efficiency:

    • Fully automated assay processing: from reading of sample tube bar codes to reporting of results
    • Average throughput up to 130 tests per hour2, and its high onboard capacity of up to 100 samples and 35 reagents provides a walkaway time of more than 2 hours
    • Wide measuring ranges enable fewer repeats
    • User-friendly software facilitates easy operation
    • Bidirectional host interface for convenient transfer of assay requests and results to the laboratory information system (LIS)

    Flexible, efficient operation

    • Continuous loading and reloading of samples and/or reagents without interrupting the system’s current workload
    • Random-access processing eliminates sample batching
    • Accommodates standard sample tubes as well as micro cups for low-volume samples, such as samples from pediatric patients

    Confident, consistent results

    • Confidence in results when analyzing samples with extremely high analytical concentrations
    • Optimized reaction conditions and assay-specific, automated pre-reaction protocols ensure valid results without operator intervention
    • Specimen level detection and positive barcode identification for samples, reagents, standards and controls to reduce human error

    Improved workflow efficiency through automation

    • Ability to connect to Aptio® Automation and FlexLab Automation solutions
    • Interface module transfers sample tubes from the track into the BN II racks and pushes the racks onboard the analyzer
    • Reduces manual interaction
    • Extends walkaway capability
    • Continuous access to reagents and consumables
    • Enables manual loading of specialty samples, when needed

    Innovative assay menu

    • Broad menu available from one source; over 60 assay protocols for management of various clinical indications
    • Routine and specialty assay consolidation
    • Innovative markers including monoclonal kappa and lambda free light chains (FLC), cystatin C, beta-trace protein (BTP), and carbohydrate-deficient transferrin (CDT)

    Enhanced result reporting with PROTIS IT Solution

    • PROTIS® Assessment Software1 assists with interpretation support for a wide range of clinical indications
    • PROTIS IT Solution data-management software manages online data transfer between the BN II System and LIS
    • All data at a glance including graphical presentation of results, calculation of specific algorithms, and result interpretation suggestions modifiable by the user

    Assays

    Polyclonal and Monoclonal Gammopathies/ Immune System
    β2-Microglobulin
    FLC kappa
    FLC lambda
    Ig/Light Chain, type kappa
    Ig/Light Chain, type lambda
    IgA
    IgG
    IgG subclasses 1-4
    IgM

    Kidney Disease
    α1-Microglobulin urine
    α2-Macroglobulin urine3
    β2-Microglobulin urine
    β-trace protein3
    Albumin urine
    Cystatin C serum
    FLC kappa urine
    FLC lambda urine
    Ig/Light Chain, type kappa urine3
    Ig/Light Chain, type lambda urine3
    IgG urine
    NGAL3
    Transferrin urine

    Inflammation
    α1-Acid Glycoprotein
    High-Sensitivity CRP(CardioPhase® hsCRP)
    Fibrinogen
    SAA3

    Autoimmune/Rheumatoid Diseases
    ADNase B
    ASL
    C3c
    C4
    CRP
    RF

    Cardiovascular Risk/Acute Cardiac Care
    Albumin urine
    Apo A-I
    Apo B
    Cystatin C
    Fibrinogen
    High- Sensitivity CRP (CardioPhase® hsCRP)
    Homocysteine
    Lp(a)
    Myoglobin

    Chronic Alcohol Abuse
    CDT
    Transferrin (for %CDT calculation)

    Allergic Diseases
    IgE

    Nutritional Assessment
    Albumin
    CRP
    Ferritin
    Prealbumin
    RBP (retinol-binding protein)

    Coagulation Disorders
    AT-III
    Fibrinogen
    Plasminogen

    Anemia/Iron Metabolism
    Ferritin
    Haptoglobin
    Hemopexin
    sTfR
    Transferrin

    Complement Activity
    C1 Esterase Inhibitor
    C3c
    C4

    Blood-CSF Barrier Dysfunction
    Albumin
    Albumin CSF
    β-trace Protein3
    FLC kappa CSF3
    FLC lambda CSF3
    IgA
    IgA CSF
    IgG
    IgG CSF
    IgM
    IgM CSF

    Other Specialty Analytes
    α1-Antitrypsin
    α2-Macroglobulin serum
    Apo A-II3
    Apo E3
    Ceruloplasmin
    Fibronectin3

    Technical Specifications

    Measuring principle

    Nephelometry; measurement of the scattered light intensity in a fixed angle of 13 - 24 degrees

    Methods

    More than 60 programmed assay protocols

    Sample throughput

    Effective: Approx. 130 tests/hour depending on the assay mix
    Nominal: 225 tests/hour

    Analysis method

    Fixed-time kinetics, end-point measurement, VLin Integral

    Calibration

    Multi-point calibration

    Rack transport unit

    Racks for up to 8 standard or control vials
    Racks for up to 7 reagent vials
    Racks for up to 10 sample tubes

    Dilution unit

    2 frames for max. 264 dilution cups

    Size of sample tubes

    Diameter: 12 - 16 mm
    Height: 55 - 100 mm
    For pediatric samples:
    Conical microtubes with a maximum filling volume of 1.5 mL

    Barcode types

    Automatic reading of different barcode types:
    2/5 interleaved
    Codabar
    Code 39
    Code 93
    Code 128

    Reagent volume

    40 µL reagent consumption on average

    Sample dilution

    1 : 1 to 1 : 40,000

    Level detection

    For samples, standards, controls, reagents, and system liquid containers

    Reaction cuvettes

    60 reusable cuvettes

    Measuring temperature

    37 ± 1.5°C

    Light source

    Infrared high performance LED

    Wavelength

    840 ± 25 nm

    Detector

    Photodiode with integrated pre-amplifier

    Instrument dimensions and weight

    Analyzer dimensions (W x H with tubings x D)
    124 x 92 x 63 cm (49 x 36 x 25 in.)
    Computer dimensions (W x H x D)
    Approx. 19.7 x 19.7 x 3.6 cm (7.8 x 7.8 x 1.4 in)
    Depth with keyboard Approx. 74 cm (29 in.)4
    Printer dimensions (W x H x D)
    Approx. 41 x 27 x 37 cm (16 x 11 x 15 in.)4
    Total bench length Approx. 230 cm (90 in.)4
    Analyzer weight 150 kg (330 lb.)
    Terminal weight Approx. 7 kg (15.4 lb.)4

    Room environment

    Ambient temperature 
    15 to 32 °C (59 to 89 °F) 
    Relative humidity 
    Maintain between 30% and 85% (noncondensing) 
    Average thermal output 
    340 BTU/hr (100 W) in standby mode 
    975 BTU/hr (286 W) in operating mode 
    Water requirements 
    Deionized water, NCClS Type 2 
    Microbial count must not exceed 100 CFU/ml 

    Electrical installation requirements

    Voltage
    90–30 V
    190–260 V
    Power consumption
    <140 VA (stand-by-mode)
    <400 VA (operating mode)
    Host interfacing
    Download and host-query mode

    Computer and Printer

    Terminal 
    Apple Mac mini Computer
    Printer 
    Lexmark E260 D or DN or equivalent

    Connectivity

    RS232 bi-directional host interface
    Aptio® Automation and FlexLab Automation solutions
    CentraLink® Data Management System

    1

    Product availability varies by country. PROTIS IT Solution is not available for sale in the U.S.

    2

    Availability varies by country. Not available for sale in the U.S.

    3

    Connectivity to BN II System is under development. Not available for sale. Future availability cannot be guaranteed.

    4

    Not available for sale in the U.S.

    5

    Dependent on model

    6

    Sold separately

    The products/features (mentioned herein) are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Please contact your local Siemens Healthineers organization for further details.