Herx TDZ4 Dental & Oral Implant Medical Centrifuge

Overview

The Herx TDZ4 Dental & Oral Implant Medical Centrifuge is a CE-marked, ISO 13485-certified benchtop low-speed centrifuge engineered specifically for clinical and dental laboratory applications involving blood-derived biomaterials—such as platelet-rich fibrin (PRF), platelet-rich plasma (PRP), and autologous bone graft preparations used in oral implantology, periodontal regeneration, and maxillofacial surgery. Operating on the principle of sedimentation-based separation under controlled gravitational force (RCF), the TDZ4 delivers reproducible, gentle yet effective stratification of whole blood into distinct functional layers—red blood cells, buffy coat (leukocyte- and platelet-enriched fraction), and acellular plasma—without inducing excessive shear stress or hemolysis. Its design prioritizes biosafety, operational reliability, and regulatory traceability in environments subject to GLP-aligned quality systems and clinical documentation requirements.

Key Features

• High-torque brushless DC motor with microprocessor-driven control ensures consistent rotational stability across all speed ranges (0–4000 rpm), minimizing mechanical vibration and acoustic emissions (≤60 dB(A) at full load).
• Integrated dual-mode interface: 4.3-inch TFT-LCD color display supports simultaneous real-time monitoring of setpoint vs. actual RCF (×g), speed (rpm), time remaining, and temperature (ambient); touch-sensitive + tactile key operation enables glove-compatible use in sterile workflows.
• Biosafe angular rotor system features a fully encapsulated, RoHS 2015/863-compliant silicone elastomer sealing gasket, preventing aerosol escape during centrifugation of biofluids and meeting containment requirements per ISO 15189 Annex A.4 and CLSI EP25-A guidelines.
• Robust mechanical architecture includes an austenitic 304 stainless steel centrifuge chamber, triply reinforced steel front panel, and impact-resistant powder-coated enclosure—validated to withstand repeated sterilant exposure and routine decontamination protocols.
• Intelligent safety suite includes automatic imbalance detection, over-speed cutoff, over-temperature monitoring, door interlock verification, and progressive 10-step acceleration/deceleration profiles to minimize sample resuspension risk during braking.
• 20-user-programmable memory slots allow storage of validated PRP/PRF preparation protocols—including variable ramp rates, hold times, and RCF targets—with last-run recall functionality supporting continuity in high-throughput clinical settings.

Sample Compatibility & Compliance

The TDZ4 accommodates standard 10 mL conical tubes (e.g., BD Vacutainer® SST II, Greiner Bio-One PP tubes) in its fixed-angle rotor configuration (24-place, 10° angle). It is compatible with anticoagulant-treated whole blood (EDTA, citrate, heparin), serum separators, and non-sterile saline-diluted tissue homogenates common in regenerative dentistry workflows. All materials contacting samples comply with USP Class VI and ISO 10993-5 biocompatibility standards. The device carries CFDA registration (Class II medical device, registration number available upon request) and conforms to IEC 61010-1:2010 (Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use) and IEC 61326-1:2012 (EMC requirements for in vitro diagnostic equipment).

Software & Data Management

While the TDZ4 operates as a standalone instrument without network connectivity, its embedded firmware supports audit-trail-capable parameter logging: each run records timestamp, operator ID (via optional RFID badge integration), selected program, final RCF, duration, and fault codes (if triggered). Exportable via USB flash drive in CSV format, logs meet minimum data integrity criteria for FDA 21 CFR Part 11–aligned environments when paired with site-specific electronic signature policies. Firmware updates are performed offline using signed binary files distributed through Herx’s authorized service channel.

Applications

• Preparation of leukocyte- and platelet-rich fibrin (L-PRF) membranes for socket preservation and guided bone regeneration (GBR).
• Isolation of platelet-rich plasma (PRP) for intraoral soft-tissue healing augmentation and peri-implantitis management.
• Processing of autologous bone marrow aspirate concentrate (BMAC) prior to grafting procedures.
• Routine hematocrit determination and serum/plasma separation in dental practice-based point-of-care testing (POCT) labs.
• Centrifugal concentration of gingival crevicular fluid (GCF) for inflammatory biomarker analysis.

FAQ

Does the TDZ4 support rotor autoclaving?
Yes—the angular rotor and silicone gasket are rated for repeated steam sterilization at 121°C for 20 minutes; however, the main unit housing must not be autoclaved.
Can I use this centrifuge for viral vector purification?
No. The TDZ4 is designed exclusively for low-speed clinical separation tasks (≤2600 ×g); it does not meet the containment or speed requirements for lentiviral or AAV processing.
Is remote monitoring or Ethernet connectivity available?
Not natively. The TDZ4 is a closed-system device without built-in networking hardware; integration with LIMS requires external barcode-scanned run initiation and manual log import.
What is the calibration interval recommendation?
Herx recommends annual speed and timer calibration by an ISO/IEC 17025-accredited service provider, with interim verification using NIST-traceable tachometer and stopwatch.
Are replacement rotors and adapters available internationally?
Yes—original-equipment angular rotors (24×10 mL), tube adapters (for 5 mL and 7 mL tubes), and certified gaskets are distributed globally through Herx’s authorized partners under part numbers HX-TDZ4-R24 and HX-TDZ4-GSKT.