Active Device Use Case
The Active Device use case covers the safety-related parts of an active medical device: applied and accessible parts, moving parts and trapping zones, emergency stopping devices, alarms and protection devices. It links them to the Hazards, Hazardous Situations and Risk Control Measures of the Risk Management use case.
Knowledge Topics
The use case is active once your product contains these Knowledge Topics:
- Defibrillation-proof compliance
- Accessible / Applied Parts
- Trapping Zones
- Emergency Stopping devices
- Alarms
- Mechanical Protection Devices
- Means of Protection
These Knowledge Topics are optional. Add them to your product to enable the relations that use them:
- Moving Parts
- Hazard
- Risk Control Measures
- Hazardous Situation
Relationships
The diagram shows how the Knowledge Topics of this use case are connected. An arrow points from the source to the target Knowledge Topic. An arrow with two arrowheads marks a bidirectional relationship.
Each row is one trace column on the source Knowledge Topic. Allow Multiple shows whether a record can be linked to more than one target record. Bidirectional relations are also shown on the target Knowledge Topic.
| Source Knowledge Topic | Relation Name | Target Knowledge Topic | Allow Multiple | Bidirectional | Description |
|---|---|---|---|---|---|
| Defibrillation-proof compliance | Validates | Accessible / Applied Parts | Yes | No | Select the Accessible / Applied Parts that are validated by this Defibrillation proof compliance. |
| Accessible / Applied Parts | Contributes To | Hazardous Situation | Yes | No | Select the Hazardous Situations that this Accessible / Applied Part can contribute to. |
| Moving Parts | Can Cause | Hazard | Yes | No | Select the Hazards that can be caused by this Moving Part. |
| Trapping Zones | Can Cause | Hazard | Yes | No | Select the Hazards that can be caused by this Trapping Zone. |
| Secured by | Risk Control Measures | Yes | No | Select the Risk Control Measures that secure this Trapping Zone. | |
| Emergency Stopping devices | Stops | Moving Parts | Yes | Yes | Select the Moving Parts that are stopped by this Emergency Stopping Device. |
| Implements | Risk Control Measures | Yes | No | Select the Risk Control Measures that are implemented by this Emergency Stopping Device. | |
| Alarms | Implements | Risk Control Measures | Yes | No | Select the Risk Control Measures that are implemented by this Alarm. |
| Mechanical Protection Devices | Implements | Risk Control Measures | Yes | No | Select the Risk Control Measures that are implemented by this Mechanical Protection Device. |
| Means of Protection | Secures | Accessible / Applied Parts | Yes | No | Select the Accessible / Applied Parts that are secured by this Means of Protection. |
Integration with Other Use Cases
Knowledge Topics that belong to more than one use case connect those use cases. This use case shares Knowledge Topics with:
- Essential Performance – Means of Protection, Hazardous Situation
- Requirements – Risk Control Measures
- Risk Management – Hazard, Risk Control Measures, Hazardous Situation
- Software Engineering – Risk Control Measures, Hazardous Situation
- Summative Evaluation – Hazardous Situation
- Usability Engineering – Hazard, Hazardous Situation