D2.1 Requirements and Specification - CORBYS

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D2.1 Requirements and Specification Reason / Comments: Comment: One important design challenge in order to make the system usable is to select a minimum sensor configuration that gives all essential information while allowing easy mounting and dismounting of a low number of sensor devices. Indicative priority Mandatory Requirement No.: HSS18 Name: Number of physiological sensor probes on the patients Description: For ease-of-use purposes, it will be desirable to combine several sensors into single devices, thereby reducing the experienced system complexity Reason / Comments: Indicative priority Desirable Requirement No.: HSS19 Name: Signal connection of physiological sensors to the CORBYS system Description: Sensor data signals will be sent through electrical wires/cables Reason / Comments: Indicative priority Mandatory Requirement No.: HSS20 Name: Signal connection of physiological sensors to the CORBYS system Description: For ease of use purposes, possibilities to make some sensor units transmit data using wireless communication protocols will be considered Reason / Comments: Indicative priority Optional 5.2.2 Non Functional Requirements 5.2.2.1 Performance Requirement No.: HSS21 Name: Intended duration of continuous usage of physiological sensors Description: Anticipation: A therapy session will last up to 2 hours Reason / Comments: Usage scenario perspectives must be provided by clinical partners. The intended duration of usage affect the sensor technologies to chose from Indicative priority Mandatory Requirement No.: HSS22 Name: Intended duration of continuous usage of physiological sensors Description: Anticipation: 8 hour sessions Reason / Comments: Indicative priority Desirable Requirement No.: HSS23 Name: Intended duration of continuous usage of physiological sensors Description: If CORBYS becomes a “community walker” gait assistance system, usage sessions could last from morning to evening. Reason / Comments: Indicative priority Optional 5.2.2.2 Safety and reliability Physiological sensors safety and comfort to use: Requirement No.: HSS24 Name: Electrical measurement system safety 32
D2.1 Requirements and Specification Description: Within Consortium electronic systems are acceptable as long as they are tested and deemed safe for the CORBYS users (e.g. complete user shielding from 220V/50Hz). Reason / Comments: Comments: It is important to discuss local human subjects research requirements with respect to carrying out human subjects testing using “investigational” sensors and concepts like CORBYS Keep in mind that the system should be safe for both patient and professionals Indicative priority Mandatory Requirement No.: HSS25 Name: Electrical measurement system safety Description: CE Medical device standard electrical safety Reason / Comments: Indicative priority Desirable Requirement No.: HSS26 Name: Electrical measurement system safety Description: Medical device CE approvals on all sensor components (For a commercial product after CORBYS) Reason / Comments: Indicative priority Optional Requirement No.: HSS27 Name: Sensor systems should not be invasive or excessively obtrusive Description: In vivo (implanted) sensor systems are not a part of the CORBYS physiological measurement system Sensor concepts probing human fluidic samples (blood, urine, saliva etc) are excluded Sensor concepts probing human body openings (such as rectal core temperature measurements and breath air gas analysis) are excluded Reason / Comments: Indicative priority Mandatory Requirement No.: HSS28 Name: Limitations in the range of acceptable users Description: Based on user safety concerns, the physiological measurements system might not be used on patient groups such as: � Patients with electronic implants � Patients with certain dermatologic conditions � Patients with limitations in cognitive capabilities � Others - to be decided Reason / Comments: Indicative priority Mandatory Requirement No.: HSS29 Name: Mounting and removal sensors on the patient Description: The physiological sensors will be mounted and removed by trained clinical rehabilitation professionals Reason / Comments: Usage scenario perspectives must be provided by clinical partners Indicative priority Mandatory Requirement No.: HSS30 Name: Mounting of individual sensor components directly on the user’s skin Description: Certain physiological sensors (for example electrode based) can be placed at optimum measurement locations, directly on the skin of the patient. Reason / Comments: Usage scenario perspectives must be provided by clinical partners : This requirement implies that some sensors will have to be placed under the patient’s layers of clothing, and possibly expose some body parts during mounting 33
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D2.1 Requirements and Specification - CORBYS

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