D2.1 Requirements and Specification - CORBYS
D2.1 Requirements and Specification - CORBYS
D2.1 Requirements and Specification - CORBYS
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<strong>D2.1</strong> <strong>Requirements</strong> <strong>and</strong> <strong>Specification</strong><br />
Description: Within Consortium electronic systems are acceptable as long as they are tested <strong>and</strong> deemed<br />
safe for the <strong>CORBYS</strong> users (e.g. complete user shielding from 220V/50Hz).<br />
Reason / Comments: Comments:<br />
It is important to discuss local human subjects research requirements with respect to<br />
carrying out human subjects testing using “investigational” sensors <strong>and</strong> concepts like<br />
<strong>CORBYS</strong><br />
Keep in mind that the system should be safe for both patient <strong>and</strong> professionals<br />
Indicative priority M<strong>and</strong>atory<br />
Requirement No.: HSS25<br />
Name: Electrical measurement system safety<br />
Description: CE Medical device st<strong>and</strong>ard electrical safety<br />
Reason / Comments:<br />
Indicative priority Desirable<br />
Requirement No.: HSS26<br />
Name: Electrical measurement system safety<br />
Description: Medical device CE approvals on all sensor components (For a commercial product after<br />
<strong>CORBYS</strong>)<br />
Reason / Comments:<br />
Indicative priority Optional<br />
Requirement No.: HSS27<br />
Name: Sensor systems should not be invasive or excessively obtrusive<br />
Description: In vivo (implanted) sensor systems are not a part of the <strong>CORBYS</strong> physiological<br />
measurement system<br />
Sensor concepts probing human fluidic samples (blood, urine, saliva etc) are excluded<br />
Sensor concepts probing human body openings (such as rectal core temperature<br />
measurements <strong>and</strong> breath air gas analysis) are excluded<br />
Reason / Comments:<br />
Indicative priority M<strong>and</strong>atory<br />
Requirement No.: HSS28<br />
Name: Limitations in the range of acceptable users<br />
Description: Based on user safety concerns, the physiological measurements system might not be used on<br />
patient groups such as:<br />
� Patients with electronic implants<br />
� Patients with certain dermatologic conditions<br />
� Patients with limitations in cognitive capabilities<br />
� Others - to be decided<br />
Reason / Comments:<br />
Indicative priority M<strong>and</strong>atory<br />
Requirement No.: HSS29<br />
Name: Mounting <strong>and</strong> removal sensors on the patient<br />
Description: The physiological sensors will be mounted <strong>and</strong> removed by trained clinical rehabilitation<br />
professionals<br />
Reason / Comments: Usage scenario perspectives must be provided by clinical partners<br />
Indicative priority M<strong>and</strong>atory<br />
Requirement No.: HSS30<br />
Name: Mounting of individual sensor components directly on the user’s skin<br />
Description: Certain physiological sensors (for example electrode based) can be placed at optimum<br />
measurement locations, directly on the skin of the patient.<br />
Reason / Comments: Usage scenario perspectives must be provided by clinical partners :<br />
This requirement implies that some sensors will have to be placed under the patient’s layers<br />
of clothing, <strong>and</strong> possibly expose some body parts during mounting<br />
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