Appendix
Medical Standard
• Anyone who connects additional equipment to the signal input parts or signal output parts when
configuring a medical system is responsible for ensuring that the system complies with the
requirements of IEC/EN60601-1.
•
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 in which such effects
are avoided.
Classification of Equipment
- Electric shock protection type: Class I
- EMC class: EN60601-1-2:2015 Group 1 Class A
-
Medical device classification (EU): Class I
- Mode of operation: Continuous
-
IP class: IP32 (The IPx2 protection level is effective when the monitor is installed so it cannot be
put at a slant.)
25
Appendix