51
Operations & Maintenance Manual: Product Specifications
0900‑5017‑ETEE REV‑05
ELECTROMAGNETIC COMPATIBILITY
The system is designed to be in compliance with IEC60601‑1‑2, which contains electromagnetic compatibility
(EMC) requirements for medical electrical equipment. The limits for emissions and immunity specified in this
standard are designed to provide reasonable protection against harmful interference in a typical medical
installation.
The system complies with the applicable essential performance requirements specified in IEC60601‑1
and IEC60601‑2‑18. Results of immunity testing show that the essential performance of the system is not
affected under the test conditions described in the following tables. For more information about the essential
performance of the system, see Essential Performance on page1.
ELECTROMAGNETIC EMISSIONS
Table 12. Guidance and Manufacturer’s Declaration—Electromagnetic Emissions
The system is intended for use in the electromagnetic environment specified below. The customer or the user
of the system should ensure that it is used in such an environment.
EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT – GUIDANCE
RF emissions
CISPR 11
Group 1
The system uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A
The system is suitable for use in all establishments other than
domestic and those directly connected to the public low‑voltage
power supply network that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC61000‑3‑2
Class A
Voltage fluctuations/
flicker emissions
IEC61000‑3‑3
In compliance
ELECTROMAGNETIC IMMUNITY
Table 13. Guidance and Manufacturer’s Declaration —Electromagnetic Immunity
The system is intended for use in the electromagnetic environment specified below. The customer or the user
of the system should ensure that it is used in such an environment.
IMMUNITY TESTS IEC60601 TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC ENVIRONMENT
– GUIDANCE
Electrostatic discharge
(ESD)
IEC61000‑4‑2
± 8kV contact
± 16kV air
In compliance
Floors should be wood, concrete,
or ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.