MC10 BioStamp nPoint - Page 56

56
BioStamp nPoint User Manual
• Investigator Portal, Investigator App, and/or Link App can’t connect to
MC10 MDDS;
• Erroneous data transfer between Investigator Portal, Investigator App,
and/or Link App and MC10 Cloud;
• Data corruption on MC10 Cloud due to foreseeable misuse (i.e. hacking);
• Investigator App or Link App can’t congure/control BioStamp Sensor;
• Link Hub cannot control/download BioStamp Sensor;
• Erroneous data transfer between BioStamp Sensor and Link Hub;
• Link App cannot control/download smart charger;
• Erroneous data transfer between Link App and Link Hub;
• Data corruption on smart charger due to foreseeable misuse (i.e. hack-
ing).
Connection of the system to an IT-network that includes other equipment
could result in previously unidentied risks to patients, operators, or third
parties. The responsible organization should identify, analyze, evaluate and
control these risks. Subsequent changes to the IT-network could introduce
new risks and require additional analysis. Changes to the IT-network include:
• changes in the IT-network conguration;
• connection of additional items to the IT-network;
• disconnecting items from the IT-network;
• update of equipment connected to the IT-network;
• upgrade of equipment connected to the IT-network.