Olympus EVIDENT BX46 Clinical Microscope
| Brand | Olympus/EVIDENT |
|---|---|
| Origin | Japan |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | BX46 |
| Pricing | Upon Request |
Overview
The Olympus EVIDENT BX46 is a high-performance upright clinical microscope engineered for routine diagnostic pathology, cytology, and hematology applications in hospital laboratories and academic medical centers. Designed around a modular, ergonomic optical platform, the BX46 implements Olympus’ advanced UIS2 (Universal Infinity System) optical architecture—delivering diffraction-limited resolution, high color fidelity, and consistent contrast across all magnifications. Its core optical design follows Köhler illumination principles with a built-in 6V30W halogen illuminator and precision field/condenser diaphragms, ensuring uniform brightness and optimal signal-to-noise ratio for brightfield, phase contrast, and optional polarized light observation. The microscope’s rigid, low-vibration cast-aluminum stand and anti-scratch, anti-fungal coated optics support long-term stability and compliance with ISO 10993-5 biocompatibility requirements for clinical device surfaces.
Key Features
- Ergonomic inclined binocular head (30° tilt) with interpupillary adjustment (50–76 mm) and diopter compensation (±5 dpt) to reduce operator fatigue during extended examination sessions.
- Revolving nosepiece accommodating up to five objectives (standard configuration: 4×, 10×, 40×, 100× oil), all equipped with parfocal, parcentric correction and anti-reflective multi-layer coatings optimized for visible-light transmission (400–700 nm).
- Motorized or manual stage options available; standard mechanical stage features X-Y travel (76 × 52 mm), vernier scales (0.1 mm resolution), and specimen clip retention for glass slides and cytology brushes.
- Integrated LED-ready illumination base compatible with optional 3W white LED modules—supporting stable, flicker-free illumination with >50,000-hour lifetime and no warm-up delay.
- Compliant with IEC 61000-6-3 (EMC emissions) and IEC 61000-6-1 (EMC immunity), meeting essential safety requirements for Class I medical electrical equipment per IEC 60601-1.
Sample Compatibility & Compliance
The BX46 accommodates standard 1 mm-thick, 26 × 76 mm glass microscope slides and 22 × 22 mm coverslips. It supports routine histopathological sections (paraffin-embedded, H&E-stained), liquid-based cytology preparations (e.g., ThinPrep®), peripheral blood smears, bone marrow aspirates, and Gram-stained bacterial cultures. All optical components are certified free of hazardous substances per RoHS Directive 2011/65/EU. The system meets regulatory expectations for clinical microscopy under CLIA (Clinical Laboratory Improvement Amendments) and CAP (College of American Pathologists) accreditation programs. Optional accessories—including graduated eyepiece reticles, calibrated stage micrometers, and objective lens identification rings—enable traceable measurement protocols aligned with ISO/IEC 17025 documentation standards.
Software & Data Management
While the BX46 operates as a standalone optical instrument, it integrates seamlessly with third-party digital imaging systems via C-mount (23.2 mm) or optional trinocular port (22 mm). When paired with Olympus cellSens™ Entry or cellSens™ Standard software (sold separately), users gain access to image capture, annotation, measurement (length, area, particle count), and report generation with embedded metadata (objective magnification, exposure time, date/time stamp). All acquired data comply with DICOM Supplement 146 for pathology imaging workflows and support audit trails required under FDA 21 CFR Part 11 when deployed within validated laboratory information systems (LIS).
Applications
- Routine histopathology screening and sign-out of surgical specimens and biopsies.
- Hematology differential counts and morphology assessment of peripheral blood and bone marrow aspirates.
- Cytology evaluation including Pap smears, urine sediment analysis, and fine-needle aspiration (FNA) specimens.
- Mycology and microbiology workups using lactophenol cotton blue or Gram staining protocols.
- Quality control of immunohistochemistry (IHC) staining consistency prior to automated slide scanning.
FAQ
Is the BX46 compliant with FDA 510(k) clearance for clinical diagnostics?
Yes—the BX46 is classified as a Class I exempt medical device under 21 CFR 864.1850 and carries CE marking under the EU MDR (2017/745) for in vitro diagnostic use.
Can the BX46 be upgraded to support fluorescence observation?
No—fluorescence capability requires the BX43 or BX53 platform with dedicated excitation filter cubes and mercury/xenon lamp housings; the BX46 optical path is optimized exclusively for transmitted-light modalities.
What is the warranty coverage for the BX46 in North America?
Olympus EVIDENT provides a standard 2-year limited warranty covering parts and labor for defects in materials and workmanship, extendable to 3 years with registered service contract enrollment.
Does the BX46 support motorized focus or Z-stack acquisition?
Not natively—the BX46 features a coaxial coarse/fine focusing mechanism with 2 µm fine-focus graduation; motorized Z-control requires integration with an external motorized focus drive and compatible imaging software.
Are replacement objectives and condensers interchangeable with older BX41 or BX45 models?
Yes—all UIS2-series objectives, Abbe condensers (e.g., 1.25 NA), and centerable condenser modules maintain full mechanical and optical compatibility across the BX41/BX45/BX46 product line.
