Device Description – CardioMonitor Pro ECG-12¶
1. General Device Overview¶
TEST¶
1.1 Identification¶
Product Name: CardioMonitor Pro ECG-12
Model Number: CM-ECG-12-2025
Catalog / Article Number: ECG-12-001
Manufacturer: [Manufacturer Name]
Device Type: 12‑lead electrocardiograph (portable)
1.2 Regulatory Classification¶
- EU MDR Class: IIa (per MDR 2017/745)
- FDA Classification: Class II
- GMDN Code: 34060 (Electrocardiograph)
1.3 Summary¶
CardioMonitor Pro ECG-12 is a portable 12‑lead electrocardiograph for non‑invasive acquisition, display, and analysis of cardiac electrical activity in adult and pediatric patients (≥2 years). It provides high‑resolution ECG signals, automated interpretation, secure storage, and connectivity for clinical workflow integration.
2. Technical Specifications¶
2.1 Physical Characteristics¶
- Dimensions: 280 mm × 210 mm × 65 mm (L × W × H)
- Weight: 1.8 kg (without battery)
- Enclosure Material: Medical ABS, impact resistant
- Ingress Protection: IP42 (dripping water; solids >1 mm)
- Operating Temperature: +10 °C to +40 °C
- Storage Temperature: −20 °C to +60 °C
- Relative Humidity: 15% to 93% non‑condensing
2.2 Electrical Characteristics¶
- Power Supply:
- Internal Li‑Ion battery: 14.4 V, 2600 mAh
- External AC adapter: 100–240 V AC, 50/60 Hz
- Power Consumption: ≤25 W (peak)
- Operating Time: Up to 8 h continuous on full charge
- Charging Time: ~3–4 h (full cycle)
2.3 ECG Performance¶
- Leads: 12 simultaneous (I, II, III, aVR, aVL, aVF, V1–V6)
- Input Range: ±5 mV
- Resolution: 16 bit
- Sampling Rate: 1000 Hz per channel
- Bandwidth: 0.05 – 150 Hz
- Input Impedance: >10 MΩ
- CMRR: >100 dB @ 50/60 Hz
- Patient Leakage Current: <10 µA
- Baseline Noise: <15 µV (p‑p)
2.4 User Interface & Operation¶
- Display: 10.1" color TFT capacitive touchscreen, 1024×768 px
- Controls: Touch UI plus dedicated physical emergency keys
- Visualization: Real‑time simultaneous 12‑lead display
- Calibration: Automatic on system start
3. Functional Description¶
3.1 Primary Functions¶
- Continuous 12‑lead ECG acquisition
- Automated interpretation (AI‑assisted rhythm & morphology analysis)
- Internal storage (≥10,000 ECG records)
- Data transfer: Wi‑Fi, Bluetooth, USB
- Integrated thermal printer (instant reports)
- Visual & audible alarms for critical findings
3.2 Software Functions¶
- Automated measurements:
- Heart rate
- PR interval
- QRS duration
- QT/QTc
- ST segment deviation
- Rhythm & conduction disturbance detection
- Patient record management (longitudinal ECG trends)
- HIS / EMR integration (standards‑based interfaces)
3.3 Accessories & Consumables¶
- Standard electrode set (10 disposable adhesive electrodes)
- 12‑lead patient cable (color coded)
- Thermal paper roll 80 mm
- Padded carry case
- International AC power adapters
- Multilingual user manual
4. Intended Use¶
4.1 Clinical Indications¶
Designed for:
- Routine resting ECG examinations
- Diagnostic evaluation of suspected cardiac conditions
- Follow‑up of known cardiovascular disease
- Pre‑operative cardiac assessment
- Emergency / acute care support (intermittent use)
4.2 User Profile¶
- Trained healthcare professionals (physicians, nurses, medical assistants)
- Minimum qualification: Basic ECG acquisition & interpretation training
4.3 Patient Population¶
- Age: Adults & children ≥2 years
- Weight Range: 10–200 kg
- Care Setting: Inpatient and outpatient
5. Contraindications & Warnings¶
5.1 Contraindications¶
No absolute contraindications for standard 12‑lead ECG acquisition.
Relative considerations:
- Severe skin lesions at electrode sites
- Excessive body hair without adequate skin prep
5.2 Warnings¶
- Not intended for continuous monitoring (>30 min)
- Not for use inside MRI environment
- Do not use during active defibrillation procedures
- Electrical safety conform IEC 60601‑1
6. Quality Assurance & Validation¶
6.1 Conformity¶
- CE Mark: MDR 2017/745
- FDA 510(k): Clearance obtained (predicate device equivalence)
- Standards:
- IEC 60601‑1 (General safety)
- IEC 60601‑2‑25 (ECG devices)
- IEC 60601‑2‑51 (Ambulatory / Holter)
- ISO 13485 (QMS)
6.2 Clinical Evaluation¶
- Clinical validation >500 patient datasets
- Algorithm performance benchmarked vs. reference interpretations
- Sensitivity >95% (critical arrhythmias)
- Specificity >98% (normal rhythm classification)
7. Service & Support¶
7.1 Maintenance¶
- Preventive maintenance recommended every 12 months
- Calibration interval: 24 months
- Network‑delivered software / algorithm updates
7.2 Warranty & Support¶
- Hardware warranty: 2 years
- Software support lifecycle: 5 years
- 24/7 technical support hotline
8. Environmental Considerations¶
8.1 End‑of‑Life / Disposal¶
- Dispose according to WEEE regulations
- Batteries handled per local regulatory guidance
- Recyclable packaging materials
8.2 Sustainability¶
- RoHS compliant
- Energy‑efficient design (optimized power stages)
- Durable components for extended service life
Document Version: 1.0
Created: 2025-09-21
Next Review: 2026-09 (planned)
Author: [Name]
Approved By: [Name]
Anhang D: Änderungshistorie¶
| Datum | Version | Autor | Änderungen |
|---|---|---|---|
| 19. November 2025 | 1 | Unbekannt | feat: Add comprehensive device description for CardioMonitor Pro ECG-12. |
| 19. November 2025 | 0.1.0 | Unbekannt | Automatische Metadatenaktualisierung |
| 17. November 2025 | 0.0.1 | Unbekannt | Automatische Metadatenaktualisierung |