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 />
Indicative priority M<strong>and</strong>atory<br />
Requirement No.: HSS31<br />
Name: Mounting of individual sensor components directly on the user’s skin<br />
Description: Less optimal, but more user friendly locations can be used.<br />
Reason / Comments:<br />
Indicative priority Desirable<br />
Requirement No.: HSS32<br />
Name: Placement of sensor components on the patient<br />
Description: All sensor components should be clearly marked in order to reduce the risk of placing<br />
sensors in incorrect measurement positions (e.g. mix left <strong>and</strong> right)<br />
Reason / Comments:<br />
Indicative priority M<strong>and</strong>atory<br />
Requirement No.: HSS33<br />
Name: Placement of sensor components on the patient<br />
Description: Preferably automated detection mechanisms to avoid the risk of incorrect placement<br />
Reason / Comments:<br />
Indicative priority Optional<br />
5.2.2.3 Other<br />
Requirement No.: HSS34<br />
Name: Physiological sensor biocompatibility issues<br />
Description: Sensors should not cause irritations/inflamatic responses or pain during the designated<br />
duration of <strong>CORBYS</strong> rehabilitation sessions.<br />
Sensors can be temporarily attached to the patient using e.g. medical grade adhesive tape<br />
Reason / Comments:<br />
Indicative priority M<strong>and</strong>atory<br />
Requirement No.: HSS35<br />
Name: Physiological sensor biocompatibility issues<br />
Description: EC Medical device st<strong>and</strong>ard biocompatibility testing of all materials interfacing the patient<br />
Reason / Comments:<br />
Indicative priority Optional<br />
Requirement No.: HSS36<br />
Name: Physiological sensor hygienic issues<br />
Description: Physiological sensor interfacing the patient’s skin directly should be possible to clean or<br />
replace from patient to patient:<br />
Single use probes<br />
Multiple use probes that have smooth surfaces <strong>and</strong> that can be cleaned in appropriate<br />
detergents<br />
Reason / Comments:<br />
Indicative priority M<strong>and</strong>atory<br />
Requirement No.: HSS37<br />
Name: Time required to mount or dismount all physiological sensors<br />
Description: For a trained user, it should be possible to mount all sensors within the maximum time<br />
required for the entire start-up <strong>and</strong> shut-down times targeted for the entire <strong>CORBYS</strong> system.<br />
Time allocated for the physiological sensor system alone is TBD.<br />
Reason / Comments: The consortium need to discuss this issue considering all the different procedures<br />
(adjustments, configurations, fixing of body <strong>and</strong> limbs, mounting of sensors, initiation of<br />
protocols) required prior to or after a therapy session.<br />
Indicative priority M<strong>and</strong>atory<br />
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