· The VMANX Disposable EEG Sensor is engineered for clinicalelectroencephalography (EEG) monitoring.
· They feature a three-layer composite structure, manufacturedrough precision printing, die-cutting, and assembly processe.
· The product meets stringent requirements for high signal fidelity,biocompatibility,and electrical safety.
· It is suitable for use in operating rooms, ICUs, and for dynamicEEG monitoring scenarios.
· Complies with the ISO 13485 Medical Devices QualityManagement System.
| Structural Design | ||
| Layer | Material/Process | Function |
| Top Layer | Medical PET Film+ Sceen-Printed Ag Conductive Layer | Medical Foam Adhesive (ISO 10993 Certified) |
| Middle Layer | Silver/Silver Chloride (Ag/AgCl) Sensing Electrode | Stable biopotential conversion, reduced polarization |
| Base Layer | Medical Foam Adhesive (ISO 10993 Certified) | Skin adhesion, pressure dispersion, comfort |
| Electrical Performance | |||
| Parameter | Test Condition | Specification | Standard |
| AC Impedance | 10Hz, electrode-skin interface | ≤5 kΩ(Typ.≤3 kΩ) | IEC 60601-2-26 |
| DC Offset Voltage | 200nA input bias current | s±100mV | ANSI/AAMI EC12 |
| Internal Noise | 0.5-100 Hz bandwidth | ≤2μVpp | IEC 60601-2-26 |
| Defibrillation Recovery | Post 5kV defibrillation | Recovery time ≤10 sec | IEC 60601-2-26 |
| Post-Defibrillation Voltage (30s) | Immediately after discharge | ≤100mV | IEC 60601-2-26 |
| Bias Current Tolerance | ±300 nA continuous input | Output drift ≤5% | ANSI/AAMI EC12 |
| Safety & Reliability | ||
| Parameter | Specification | Standard |
| Biocompatibility | ISO 10993 Series Compliant | ISO 10993-5,-10 |
| Cytotoxicity | Non-cytotoxic (Grade 0) | ISO 10993-5 |
| Skin Sensitization | Compliant | ISO 10993-10 |
| Dielectric Withstand | 5000 VAC,60s no breakdown | IEC 60601-1 |
| Inter-Electrode Resistance | ≤1Ω | Internal Standard |
| Manufacturing & Quality Control | |
| Electrode Printing: | High-precision screen printing, Ag layer thickness tolerance ±5μm |
| Die-Cutting : | Laser-guided precision,electrode aperture accuracy ±0.1mm |
| Assembly : | Class 100,000 cleanroom,ESD-controlled environment |
| In-process Testing: | Batch sampling for impedance, peel adhesion, bioburden |
| Sterilizatio: | Ethylene Oxide (EO), residuals ≤0.ppm (ISO 11135) |
| Compliance & Certifications | |
| Quality Management : | ISO 13485:2016 certified. |
| Regulatory Compliance : | EU CE Mark (MDR 2017/745), US FDA 510(k)listed |
| Environmental Standards: | RoHS 3.0, REACH SVHC compliant |
| Packaging & Storage | |
| Primary Package: | Sterile foil pouch, 1 sensor/pouch |
| Labeling : | UDI-DI, Lot number, Expiry date |
| Storage : | 15-30℃,<70% RH,avoid direct light |
| Shelf Life: | 24 months (unopened) |
Dongguan Zhongman Industrial Co., Ltd.
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