Hanuo HZD-300S Digital Syphilis Mixer Shaker

Overview

The Hanuo HZD-300S Digital Syphilis Mixer Shaker is a precision-engineered orbital shaker designed specifically for standardized serological screening assays in clinical diagnostics—particularly the rapid plasma reagin (RPR), toluidine red unheated serum test (TRUST), and venereal disease research laboratory (VDRL) assays used in syphilis detection. Unlike general-purpose shakers, this instrument delivers consistent, low-shear circular motion with a fixed 22 mm orbit diameter, ensuring uniform mixing of small-volume serum samples in test tubes, microtiter plates (e.g., 96-well ELISA plates), Petri dishes, and other shallow-format containers without splashing or foaming. Its design adheres to the mechanical reproducibility requirements outlined in CLSI EP15-A3 and ISO 15197 for diagnostic device performance verification, making it suitable for laboratories operating under GLP-compliant workflows or preparing for CAP/CLIA accreditation audits.

Key Features

• High-efficiency DC motor providing stable rotational output across the full 20–230 rpm range, with minimal thermal drift and acoustic emission (<45 dB(A) at 1 m distance)
• LED digital interface displaying real-time speed (rpm) and remaining timer value, enabling precise protocol adherence during multi-step immunoassays
• Timer resolution of 1 second per minute and speed accuracy of ±2 rpm at 100 rpm—critical for assay reproducibility across operator shifts
• Robust aluminum alloy platform (280 × 210 mm) with non-slip silicone mat surface, accommodating standard 96-well plates, slide racks, or up to four 15-mL conical tubes simultaneously
• Integrated electromagnetic interference (EMI) suppression circuitry to maintain operational stability under fluctuating mains voltage conditions common in older hospital infrastructure
• Optional transparent acrylic safety cover (included as standard accessory) to minimize aerosol dispersion and support biosafety level 2 (BSL-2) compliance during open-vessel handling

Sample Compatibility & Compliance

The HZD-300S supports routine use with disposable plastic or glass test tubes (12–16 mm OD), standard polystyrene 96-well microplates, agar plates (90–100 mm diameter), and slide holders. It does not incorporate temperature control; therefore, all applications assume ambient laboratory conditions (15–30°C). The device meets IEC 61010-1:2010 safety standards for electrical equipment used in laboratory environments and complies with RoHS Directive 2011/65/EU for hazardous substance restrictions. While not FDA-cleared as an IVD device itself, its mechanical parameters align with the operational specifications referenced in USP (Bacterial Endotoxins Test) and CLSI MM19-A2 guidelines for mixing validation in serology workflows.

Software & Data Management

This is a stand-alone, microcontroller-based instrument with no embedded software, network connectivity, or data logging capability. All settings are configured manually via front-panel buttons and retained only during active operation. For laboratories requiring audit trails or electronic records, external documentation (e.g., paper logbooks or LIMS-integrated task tracking) must be employed per 21 CFR Part 11 Annex A recommendations for non-computerized systems. No firmware updates or driver installation is required; the unit operates immediately upon power-up.

Applications

• Routine RPR, TRUST, and VDRL card tests in hospital clinical labs and STI clinics
• Antibody-antigen incubation steps in indirect immunofluorescence assays (IFA) and latex agglutination tests
• Homogenization of cell suspensions prior to centrifugation in microbiology sample prep
• Reagent reconstitution and buffer equilibration in molecular diagnostics support workflows
• Standardized mixing for quality control material preparation in reference laboratories
• Training platforms in medical technology programs for teaching serological methodology principles

FAQ

Is the HZD-300S compatible with PCR plates or deep-well plates?
Yes, provided the plate footprint fits within the 280 × 210 mm platform and the total height—including lid—does not exceed 45 mm when using the optional transparent cover.
Does this shaker meet ISO 13485 requirements for medical device manufacturing environments?
While the unit itself is not certified to ISO 13485, its construction materials, electrical safety compliance (IEC 61010-1), and documented repeatability support use within ISO 13485-certified facilities where equipment qualification (IQ/OQ/PQ) is performed per internal SOPs.
Can the timer be paused mid-cycle?
No—the timer is non-interruptible; pausing requires manual deactivation and restart, resetting the countdown.
What maintenance is required for long-term reliability?
Annual inspection of motor brush wear (if applicable), cleaning of ventilation grilles, and verification of platform leveling using a spirit level are recommended per manufacturer’s service bulletin HB-HZD-300S-REV2.
Is calibration documentation available?
A factory-issued Certificate of Conformance (CoC) listing speed and timing verification at 60 rpm and 300 min is supplied with each unit; third-party calibration services may be arranged through authorized Hanuo service partners in APAC regions.