System of Spinal Pedicle Screw-Rod System Torsional Fatigue Tester

Standard 

• YY/T 0857-2011 (China): Specifies torsional fatigue testing protocols for spinal pedicle screw-rod systems, including load ratios, frequency, and failure criteria.
• YY/T 1560-2017 (China): Defines methodologies for evaluating the fatigue strength of spinal implant assemblies under complex loading.
• ASTM F1717-18 (International): Standard test methods for spinal implant constructs in vertebrectomy models.
• ASTM F2706-19: Specifies static and fatigue testing requirements for occipito-cervical and occipito-cervico-thoracic spinal implants.

Product Advantages

1. Multi-Axis Torsion Control: Advanced electromagnetic actuators maintain R=-1 load ratio (fully reversed torsion) with ±0.05% accuracy.
2. 5 Million Cycle Endurance: Proven capability to complete YY/T 0857’s 5×10⁶-cycle fatigue test without calibration drift.
3. Dynamic Angle Control: 0.001° resolution ensures precise replication of physiological spinal motion.
4. Real-Time Fracture Detection: AI-powered acoustic emission monitoring identifies micro-cracks at sub-millisecond intervals.
5. Intuitive Workflow: 21.5” capacitive touchscreen with gesture control and pre-loaded SOPs for 10+ implant geometries.
6. Modular Environmental Chambers: Quick-swap pods for simulated physiological (-20°C to +50°C) and corrosive environment testing.

Product Features

• Electromagnetic Servo Motors: Dual-axis torsional actuators (±180° rotation, 50 Nm peak torque).
• 6-DOF Kinematic Simulation: Replicates natural spinal motion (flexion/extension ±20°, lateral bending ±15°, axial rotation ±10°).
• Dynamic Load Control: 0.1–5 Hz frequency range with programmable waveforms (sine, square, random, custom).
• Thermal-Mechanical Chamber: ±0.3°C temperature stability with integrated humidity control (10–95% RH).
• High-Speed Imaging Ready: Syncs with external cameras for full-field strain mapping (DIC optional upgrade).
• Safety System: Triple-redundant emergency stop, overload clutches, and laser-based specimen breakage detection.

技術パラメータ

Accessories

1. Spinal Implant Fixture Kit:
   • Self-centering pedicle screw clamps (4.5–7.5 mm diameter compatibility)
   • Rod-bending jigs with laser-aligned loading anvils
2. Thermal-Mechanical Chamber:
   • 20L capacity with rapid cooling/heating (15°C/min)
   • 316L stainless steel interior with HEPA filtration
3. TorsionMaster Pro Software:
   • Automated S-N curve generation and fatigue limit calculation
   • 21 CFR Part 11-compliant audit trail with blockchain timestamping
   • Remote monitoring via dedicated iOS/Android app
4. Operator Kit:
   • Calibrated torque wrench set (0.5–50 Nm)
   • Specimen alignment gauges (ASTM F1717 compliant)
5. Calibration Bundle:
   • NIST-traceable torque calibration weights
   • Angular encoder verification tool
6. Safety Kit:
   • Laser safety curtains
   • Acoustic enclosure with 30 dB noise reduction