Sensitive imago 535 is equivalent to European device model 530. Their functionality is the same. The only distinctive feature consists in different requirements to device assembly. Engineering requirements for health testing devices in the USA fully correspond to those in the EU. With respect to the FDA norms, constituent elements of a device are under more strict control policy. Requirements to magnetic safety in the USA are different.
Model 535 is assembled meeting new quality management system ISO 9001 full adopted in 2013. The device has passed all required run-tests in countries of the EU. Medical factories management, manufacturing and scientific research works have been certified according to ISO 13485.
Specifications
- Class
- Business
- Manufacture
- Alfa-Med
- Software
- Life Stream
- Mains voltage
- ~110 V (±10%)
- Power-line frequency
- 60±1 hz
- Dimensions
- 200x250x95
- Net weight (kg)
- 1,0
- Gross weight (kg)
- 5,5