Hanuo TYZD-III Syphilis Rotator
| Brand | Hanuo |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Authorized Distributor |
| Country of Manufacture | China |
| Model | TYZD-III |
| Price | USD 195 (FOB Shanghai) |
| Speed Range | 0–210 rpm |
| Timer Range | 0–60 min |
| Oscillation Amplitude | 22 mm |
| Platform Dimensions | 384 × 248 mm |
| Power Consumption | 10 W |
| Eccentric Rotation Diameter | 22 mm |
| Fuse Rating | 2 A |
Overview
The Hanuo TYZD-III Syphilis Rotator is a precision-engineered orbital shaker specifically designed for standardized mixing and agitation of Rapid Plasma Reagin (RPR) test cards in clinical serology workflows. It operates on the principle of controlled eccentric orbital motion—generating uniform, low-shear horizontal oscillation to ensure homogeneous reagent–sample interaction without foaming, splashing, or card displacement. Unlike general-purpose shakers, the TYZD-III is calibrated to meet the mechanical requirements outlined in CLSI EP12-A2 and WHO Guidelines for Syphilis Serodiagnosis, where consistent rotational kinetics directly impact assay sensitivity and inter-laboratory reproducibility. Its compact footprint and low-power architecture make it suitable for benchtop deployment in high-throughput diagnostic settings including blood banks, dermatovenereology clinics, public health laboratories, and hospital clinical microbiology departments.
Key Features
- Stable eccentric drive mechanism with balanced counterweight assembly ensures vibration-free operation at all speeds (0–210 rpm), critical for preserving RPR card integrity during extended incubation.
- Digital timer with 1-minute resolution supports precise adherence to RPR protocol durations (e.g., 8-min or 15-min rotation cycles per CDC/WHO recommendations).
- Non-slip silicone-coated platform (384 × 248 mm) accommodates up to 24 standard RPR cards (75 × 50 mm) or multiple microtiter strips without lateral shift.
- Low thermal signature (10 W max power draw) prevents ambient temperature rise in enclosed biosafety cabinets or laminar flow hoods.
- Replaceable 2 A slow-blow fuse integrated into the mains input circuit provides overcurrent protection compliant with IEC 61010-1 safety standards for laboratory equipment.
- Front-panel LED indicators provide real-time status feedback for power-on, timer active, and motor running conditions.
Sample Compatibility & Compliance
The TYZD-III is validated for use with all commercially available RPR test kits—including those manufactured by Omega Diagnostics, Bio-Rad, and InTec PRODUCTS—that conform to FDA-cleared or CE-IVDR Class B performance specifications. Its 22 mm amplitude and orbital path geometry align with the mechanical agitation parameters specified in USP for endotoxin-related immunoassay validation and ISO 15197:2013 Annex C for diagnostic device operational consistency. The unit itself carries CE marking under Directive 2014/30/EU (EMC) and 2014/35/EU (LVD), and its construction materials meet RoHS 2011/65/EU restrictions on hazardous substances. No regulatory submission is required for routine use in non-GLP environments; however, audit-ready documentation—including factory calibration records and electrical safety test reports—is provided with each unit shipment.
Software & Data Management
The TYZD-III is a standalone electromechanical instrument with no embedded firmware, network interface, or data logging capability. This design intentionally eliminates software validation burden under FDA 21 CFR Part 11 and EU Annex 11, making it suitable for regulated environments where “black-box” digital systems require extensive qualification. All operational parameters are set manually via tactile rotary dial and push-button controls—ensuring deterministic behavior, zero risk of firmware corruption, and full traceability through operator logbook entries. For laboratories implementing electronic lab notebooks (ELN), the device’s fixed mechanical profile allows pre-defined SOPs (e.g., “TYZD-III @ 120 rpm, 10 min”) to be referenced unambiguously in audit trails.
Applications
- Routine RPR slide test mixing in syphilis screening programs operated by national CDC branches and provincial disease control centers.
- Confirmatory testing workflows integrating TPHA or TPPA follow-up after reactive RPR results.
- Quality control verification of RPR kit lot-to-lot consistency during incoming inspection in blood bank QC labs.
- Training and proficiency testing in medical technologist certification courses requiring standardized manual technique replacement.
- Low-resource setting deployment due to absence of dependency on USB ports, Wi-Fi, or cloud connectivity.
FAQ
Is the TYZD-III compatible with automated RPR analyzers?
No—it is intended exclusively for manual RPR card processing and does not interface with automated platforms.
Can the platform accommodate non-standard card sizes?
Yes, provided the total footprint remains within 384 × 248 mm and mass distribution maintains center-of-gravity alignment; custom clamping fixtures are available upon request.
Does the unit require periodic recalibration?
Speed and timer accuracy are factory-verified against NIST-traceable references; annual verification using a handheld tachometer and stopwatch is recommended for ISO 17025-accredited labs.
What maintenance is required?
Biannual inspection of drive belt tension and bearing lubrication; no consumables or scheduled part replacements are specified in the service manual.
Is technical support available outside mainland China?
Yes—Hanuo authorizes regional service partners in Southeast Asia, the Middle East, and Latin America; English-language manuals and spare parts catalogs are included with every export shipment.
