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Terms and conditions for the license of the software and operating manual, including copyright provisions.
Information on manual updates, trademark ownership, and authorization requirements for reprinting or copying.
Crucial warnings about device operation, potential hazards, and compliance with manual instructions for user and patient safety.
Key considerations for the analysis algorithm, ECG trace quality, and the necessity of cardiologist validation for results.
Patient categories excluded from device use, specifically those reporting discomfort or under the influence of impairing substances.
Important notes on patient preparation, electrode placement, managing ECG noise, and device compliance with standards.
Detailed explanation of symbols found on medical devices, labels, and in the user manual, including CE marking and disposal.
Information presented on the device label, such as product name, manufacturer, serial number, and regulatory certifications.
Outlines the scope of the manual, covering the Cubestress System and its intended use, referencing other product manuals.
Specifies that the manual is for professional healthcare operators with prior knowledge of medical procedures and terminology.
Defines the cardiovascular stress test application, including analysis of ECG signals and biometric data for cardiac function assessment.
Describes the components of the Cubestress System, including software, ECG acquisition units, computers, and optional peripherals.
Lists the relevant harmonised standards for medical devices, safety, EMC, and software, ensuring compliance and performance.
General| Manufacturer | Cardioline |
|---|---|
| ECG Channels | 12 |
| Connectivity | USB |
| Power Supply | AC power |
| Dimensions | Unspecified |
| Weight | Unspecified |
| Application | Stress testing for cardiac evaluation |
| Treadmill Control | Integrated treadmill control |
| Ergometer Control | Integrated ergometer control |
