26
Appendix
Appendix
Medical Standard
•
It shall be assured that the final system is in compliance to IEC60601-1-1 requirement.
•
Power supplied equipment can emit electromagnetic waves, that could influence, limit or result in
malfunction of the monitor. Install the equipment in a controlled environment, where such effects
are avoided.
Classification of Equipment
- Type of protection against electric shock : Class I
- EMC class: EN60601-1-2:2015 Group 1 Class B
- Classification of medical device (MDD 93/42/EEC): Class I
- Mode of operation : Continuous
- IP Class : IP32