Intended Purpose – CardioMonitor Pro ECG-12¶

1. Intended Use¶

1.1 Purpose Definition¶

CardioMonitor Pro ECG-12 is intended for non‑invasive acquisition, display, analysis, and storage of the electrical activity of the heart (electrocardiogram) in adult patients and pediatric patients aged 2 years and above.

1.2 Clinical Application¶

The device is intended for:
- Routine resting ECG rhythm assessments
- Diagnostic support in cardiac rhythm disorders
- Intermittent monitoring of cardiac function
- Follow‑up of cardiology treatment / disease progression
- Pre‑operative cardiac risk evaluation

1.3 Scope of Use¶

Medical Disciplines:
- Cardiology
- Internal Medicine
- General Practice
- Emergency / Acute Care
- Preventive / Screening Medicine

Care Environments:
- Hospitals & clinics
- Physician offices
- Medical centers / outpatient facilities
- Rehabilitation facilities
- Mobile deployments (emergency service, home visit)

2. Target Patient Population¶

2.1 Inclusion Criteria¶

Adults: ≥18 years
Pediatrics: Children ≥2 years
Patients with suspected cardiovascular conditions
Patients under routine cardiac follow‑up

2.2 Exclusion Criteria¶

Infants / children <2 years
Patients with active implantable devices (special precautions required)
Patients with severe dermatological lesions at electrode sites

3. Clinical Benefit¶

3.1 Diagnostic Support¶

Arrhythmia detection: Identification of rhythm disturbances
ST segment analysis: Ischemia / infarction indication
QT interval assessment: Repolarization risk evaluation
Morphology analysis: Waveform / conduction assessment

3.2 Automated Interpretation¶

Computer‑assisted ECG evaluation
Standardized reporting per international guidelines
Signal quality control and artifact detection
Trend analysis for longitudinal follow‑up

4. User Profile¶

4.1 Intended Users¶

Primary Users:
- Cardiologists
- Internists
- General practitioners
- Residents in specialty training

Secondary Users:
- Qualified nursing staff / medical assistants
- Medical technical assistants

4.2 Qualification Requirements¶

Minimum Qualification:
- Completed medical degree OR
- Completed accredited training (assistant / MTA) with ECG instruction

Required Competencies:
- Fundamentals of electrocardiography
- Cardiovascular anatomy & physiology
- ECG interpretation & documentation
- Operation of medical diagnostic devices

5. Contraindications & Warnings¶

5.1 Contraindications¶

No absolute contraindications for performing a standard 12‑lead ECG with this device.

5.2 Relative Contraindications¶

Severe skin lesions at electrode sites
Extreme agitation or lack of cooperation
Morbid obesity (BMI >50) – may reduce signal quality

5.3 Warnings¶

Not intended for continuous monitoring
Do not rely as sole diagnostic method in life‑threatening emergencies
Pacemaker / ICD patients may exhibit pacing artifacts

6. Expected Clinical Advantages¶

6.1 Patient Benefits¶

Non‑invasive diagnostic modality
Rapid results enabling timely decisions
High precision through digital signal processing
Comfortable, ergonomic examination workflow

6.2 User Benefits¶

Intuitive operation
Automated interpretation reduces reporting time
Digital documentation & archiving efficiency
Mobile flexibility via battery operation

6.3 Quality Improvements¶

Standardized ECG acquisition per international norms
Reproducible quantitative measurements
Automatic signal quality assurance
Seamless IT infrastructure integration

7. Benefit–Risk Assessment¶

7.1 Clinical Risks¶

Overall risk profile considered very low:
- Non‑invasive (surface electrodes only)
- Meets IEC 60601-1 safety requirements
- No therapeutic energy delivery

7.2 Benefit–Risk Ratio¶

Benefit–risk ratio is clearly positive:
- High diagnostic value
- Minimal patient risk
- Supports evidence‑based therapy decisions
- Cost‑efficient diagnostic approach

Document Status: Effective from 2025-09-24
Version: 1.1.0 - Gültig ab: 17. November 2025- Erstellungsdatum: 17. November 2025- Letzte Überarbeitung: 17. November 2025Next Review: 2026-09-24

Letzte Überarbeitung: 19. November 2025Responsible Dept.: Medical Department
Nächste Überprüfung: 19. November 2026

Anhang D: Änderungshistorie¶

Datum	Version	Autor	Änderungen
19. November 2025	1.1.0	Unbekannt	Automatische Metadatenaktualisierung
17. November 2025	1.0.1	Unbekannt	Automatische Metadatenaktualisierung