System ONE-R
- For Research Use Only
- For Professional Users Only
- Not for Human Therapeutic Procedures
Safety classification and testing
System ONE-R is a CE marked research device compliant to the European Low Voltage Directive 2014/35/EU.
The system is designed and type tested in accordance with IEC 60601-1 – Part 1: General requirements for basic safety and essential performance and its relevant cascading sub standards.
The labelling has been adapted (compared to the type-tested version) for conditional release as a research-only device for use in with the relevant electrical mains input power cable. The mains power cable has been validated and approved according to internal procedures using calibrated and traceable equipment.
Final inspection before release has been performed based on guidelines and requirements for routine testing
Use environment
System ONE-R systems are suitable for use in the professional healthcare and laboratory facility environments.
