User Manual Summary
The Welch Allyn Diagnostic Cardiology Suite is a prescription device intended for use by physicians, other licensed healthcare practitioners, and trained personnel to acquire, analyze, display, transmit, and print certain physiological signals. The device is designed to operate within the inherent capabilities of an off-the-shelf laptop or PC Windows operating system.
Indications for Use
The device is intended for use in medical clinics, physician offices, and hospital settings for the following purposes:
- Acquire, analyze, display, transmit, and print certain physiological signals
- Suport 12-lead diagnostic resting ECG and diagnostic spirometry applications
- Provide patient data management functions, including communication with electronic medical records systems
The device is not intended for use as a physiological vital signs monitor or in mobile medical environments.
Regulatory Information
This device has been cleared by FDA and is substantially equivalent to the Welch Allyn CardioPerfect Workstation Software (K082478) and the Welch Allyn RScribe (K120865) ECG systems.
The user manual provides detailed information on the device’s intended use, indications for use, contraindications, and safety precautions.
Manual:
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