Technical Standards & Specifications
Comprehensive technical documentation for our 8-channel BrainBit EEG deception detection system. ISO 17025 compliant procedures, UKAS accreditation standards, and complete measurement traceability ensuring the highest levels of accuracy and reliability in the industry.
Quality Management & Compliance Status
Current Status: ISO 17025:2017 Quality Management System fully implemented
UKAS Accreditation: Application submitted September 2025 (Assessment pending)
Measurement Traceability: NPL-traceable calibration standards maintained
Equipment Classification: Medical-grade 8-channel BrainBit EEG system
Quality Assurance: Continuous monitoring and validation protocols active
8-Channel BrainBit EEG System Specifications
EEG Acquisition
| Parameter | Specification |
|---|---|
| Channels | 8 active electrodes |
| Sample Rate | 250 Hz (±0.01%) |
| Resolution | 24-bit ADC |
| Input Range | ±100 mV |
| Noise Floor | <0.5 μV RMS |
| CMRR | >110 dB |
Signal Processing
| Parameter | Specification |
|---|---|
| Bandwidth | 0.1 - 100 Hz |
| P300 Analysis | 250-600 ms window |
| Artifact Rejection | Automatic ±100 μV |
| Filter Type | Butterworth IIR |
| Processing Latency | <10 ms |
| Data Format | EDF+ compliant |
Performance Metrics
| Metric | Value |
|---|---|
| Detection Accuracy | 95.2% ±1.8% |
| Sensitivity | 94.7% (CI: 91.2-97.1%) |
| Specificity | 95.8% (CI: 92.5-98.2%) |
| False Positive Rate | 4.2% |
| Session Duration | 45-90 minutes |
| Reliability (α) | 0.94 |
Environmental & Safety
| Parameter | Specification |
|---|---|
| Operating Temp | 15-35°C |
| Humidity | 30-80% RH |
| EMC Compliance | IEC 60601-1-2 |
| Safety Standard | IEC 60601-1 |
| IP Rating | IP22 |
| Battery Life | 8+ hours |
Medical-Grade Equipment Configuration
8-Channel BrainBit EEG System
Medical-grade electroencephalography system specifically configured for P300 deception detection applications with full ISO 17025 compliance.
- 8 active gold-plated electrodes with impedance monitoring
- Wireless transmission with encrypted data protocols
- Real-time artifact detection and signal quality monitoring
- 24-bit ADC with 250Hz sampling rate for precise measurement
- Medical-grade isolation and patient safety protection
- Integrated calibration and self-test capabilities
- Professional software suite with P300 analysis algorithms
- Compatible with international EEG data standards (EDF+)
- Regulatory compliance: CE marked, FDA clearance pending
- Maintenance-free operation with automatic diagnostics
NPL-Traceable Calibration Process
Our comprehensive calibration procedure ensures measurement accuracy and traceability to national standards maintained by the National Physical Laboratory (NPL).
1
Pre-Calibration
System verification using NPL-traceable voltage standards with documented uncertainty budgets
2
Equipment Setup
Environmental conditioning and electrode impedance verification according to IEC 60601-2-26 standards
3
Signal Validation
Frequency response, noise floor, and linearity testing using precision signal generators
4
Performance Verification
P300 detection algorithm validation using standardized test protocols and reference datasets
5
Documentation
Complete calibration certificates with measurement uncertainty and traceability statements
6
Quality Assurance
Independent verification and release approval according to ISO 17025 procedures
Quality & Performance Metrics
±0.15%
Calibration Accuracy
95.2%
Detection Accuracy
<0.5μV
System Noise Floor
110dB
Common Mode Rejection
24-bit
ADC Resolution
250Hz
Sampling Rate
Measurement Uncertainty Budget:
- Calibration Standard Uncertainty: ±0.05% (k=2, 95% confidence)
- Environmental Factors: ±0.08% (temperature, humidity variations)
- System Repeatability: ±0.03% (multiple measurement variance)
- Combined Standard Uncertainty: ±0.10% (RSS combination)
- Expanded Uncertainty: ±0.20% (coverage factor k=2)
Validation & Verification:
- Inter-laboratory Studies: Participation in proficiency testing schemes
- Blind Testing: Independent validation using unknown samples
- Statistical Validation: Continuous monitoring of control charts
- Equipment Verification: Daily performance checks and trending
- Method Validation: Peer-reviewed publication and external review
Technical Documentation Repository
Complete technical documentation package supporting our quality management system and regulatory compliance framework.
Quality Manual v5.0
Complete QMS documentation including policies, procedures, and work instructions
View Summary
Technical SOPs v2.0
Standard Operating Procedures for equipment operation, calibration, and maintenance
View Summary
Equipment Specifications v9.0
Detailed technical specifications, performance characteristics, and validation data
View Summary
Calibration Procedures
NPL-traceable calibration methods with uncertainty calculations and traceability chains
View Summary
Risk Assessment
Comprehensive risk analysis including technical, operational, and clinical risk factors
View Summary
User Manual
Complete operator guide including setup, operation, troubleshooting, and safety procedures
View Summary
Management Reviews
Regular management system reviews, performance monitoring, and continuous improvement
View Summary
Corrective Actions
CAPA procedures for addressing non-conformities and implementing systematic improvements
View Summary
Professional Competence & Training
Technical Staff Qualifications:
- Lead Technical Officer: PhD Biomedical Engineering, 15+ years EEG experience
- Calibration Technicians: HNC Electronics, NPL-trained measurement specialists
- Quality Manager: MSc Quality Management, ISO 17025 Lead Assessor certified
- Clinical Specialists: Registered healthcare professionals with EEG certification
- Data Analysts: MSc Statistics/Psychology, P300 research background
Continuing Professional Development:
- Annual Training: 40+ hours per technician on latest methods and standards
- Conference Participation: International Society for Neurophysiological Monitoring
- Peer Review: Regular participation in technical working groups
- Research Collaboration: University partnerships for method development
- Professional Membership: Institute of Physics and Engineering in Medicine
External Validation:
- Peer Review Publications: 8 published papers in international journals
- Conference Presentations: 12 international conference presentations
- Industry Recognition: Innovation awards from technical societies
- Expert Testimony: Court-qualified expert witness status
- Regulatory Consultation: Advisor to standards development committees
Technology Roadmap & Future Development
Planned Enhancements (2025-2026):
- 16-Channel System: Enhanced spatial resolution with increased electrode density
- AI Integration: Machine learning algorithms for improved pattern recognition
- Real-time Analysis: Instantaneous P300 detection with live feedback
- Mobile Platform: Portable system for field deployment applications
- Cloud Analytics: Secure cloud-based analysis and reporting platform
Research & Development:
- Advanced Algorithms: Deep learning for enhanced pattern detection
- Multi-modal Integration: Combination with other physiological measures
- Population Studies: Large-scale validation across demographic groups
- Clinical Applications: Extension to medical diagnostic applications
- Regulatory Approval: FDA clearance and international medical device registration
Industry Collaboration:
- Academic Partnerships: Joint research with leading universities
- Technology Transfer: Licensing agreements with medical device manufacturers
- Standards Development: Participation in ISO/IEC working groups
- International Cooperation: Harmonization with global best practices
- Innovation Networks: Collaboration with technology incubators