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Active devices for diagnosis
Body
Active devices for diagnosis are intended to supply information for the purpose of detecting, diagnosing, monitoring, or treating physiological conditions, states of health, illnesses, or congenital deformities.
These devices may be intended to:
- illuminate a patient's body in the visible spectrum
- supply energy that will be absorbed by a patient's body
- image in vivo distribution of radiopharmaceuticals in a patient
- allow direct diagnosis or monitoring of vital physiological processes of a patient
- monitor vital physiological parameters of a patient, where the nature of any variations monitored are of a kind that could result in immediate danger to the patient (for example, variations in cardiac performance, respiration, activity of the central nervous system)
- emit ionising radiation and to be used for diagnostic radiology
- control or monitor, or directly influence, the performance of a device that emits ionising radiation for diagnosis.
Examples of active devices for diagnosis
Magnetic resonance imaging equipment, diagnostic ultrasound, evoked response stimulators, gamma cameras, electronic thermometers, stethoscopes and blood pressure monitors, electrocardiographs, monitors/alarms for intensive care, biological sensors, oxygen saturation monitors and apnoea monitors.
Question
Which of the above intended purposes is relevant for your active device for diagnosis?