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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.

Technical Parameters

ParameterSpecification
Max. Torsional Moment ±50 Nm (1 Nm resolution)
Angular Range ±180° (0.001° resolution)
Frequency Range 0.1–5 Hz (0.01 Hz increments)
Load Ratio (R) -1 to 0.1 (adjustable)
Temperature Control -20°C to +50°C (PT1000 sensors)
Humidity Control 10–95% RH (non-condensing)
Data Sampling Rate 100 kHz (synchronized across 16 channels)
Power Requirements 220V/110V ±10%, 50/60Hz, 2,500W
Dimensions (W×D×H) 1,800 × 1,200 × 2,100 mm
Weight 1,100 kg (including environmental chamber)
Noise Level <65 dB (A-weighted)

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


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