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EN 60601-1 (IEC 60601-1)
Medical electrical equipment
Part 1: General requirements for safety
EN 60601-1-1 (IEC 60601-1-1)
Medical electrical equipment
Part 1-1: General requirements for safety
Collateral standard: Safety requirements for Medical electrical systems
EN 60601-1-2 (IEC 60601-1-2)
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic compatibility; Requirements and tests
Accessory equipment connected to the analog and digital interfaces must be in com-
pliance with the respective nationally harmonized IEC standards (i.e. IEC 60950 for
data processing equipment, IEC 60065 for video equipment, IEC 61010-1 for labora-
tory equipment, and IEC 60601-1 for medical equipment). Furthermore all configura-
tion should comply with the system standard IEC 60601-1-1. Anyone who connects
additional equipment to the signal input or signal output is configuring a medical sys-
tem, and is therefore responsible that the system complies with the requirements set
forth in standard IEC 60601-1-1. The unit is for exclusive interconnection with IEC
60601-1 certified equipment in the patient environment and IEC 60XXX certified
equipment outside of the patient environment. If in doubt, consult the technical ser-
vices department or your local representative.
FCC Class B
This equipment has been tested and found to comply with the limits for a Class B dig-
ital device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against harmful interfer-
ence when the equipment is operated in a residential environment. This equipment
generates, uses, and can radiate radio frequency energy. If not installed and used in
accordance with this user's manual, it may cause harmful interference to radio com-
munications.
Note that even when this equipment is installed and used in accordance with this
user's manual, there is still no guarantee that interference will not occur. If this equip-
ment is believed to be causing harmful interference to radio or television reception,
this can be determined by turning the equipment on and off. If interference is occur-
ring, the user is encouraged to try to correct the interference by one or more of the
following measures:
! Reorient or relocate the receiving antenna.