Verathon GlideScope - ELECTROMAGNETIC COMPATIBILITY; ELECTROMAGNETIC EMISSIONS; ELECTROMAGNETIC IMMUNITY

69
Operations & Maintenance Manual: Product Specifications
ELECTROMAGNETIC COMPATIBILITY
The system is designed to be in compliance with IEC60601‑1‑2:2007, 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 IEC60601‑1 and
IEC60601‑2‑18. 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 page1.
ELECTROMAGNETIC EMISSIONS
Table 16. 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
IEC61000‑3‑2
Class A
Voltage fluctuations/
flicker emissions
IEC61000‑3‑3
Complies
ELECTROMAGNETIC IMMUNITY
Table 17. 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 IEC60601 TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC ENVIRONMENT
– GUIDANCE
Electrostatic discharge
(ESD)
IEC61000‑4‑2
± 6 kV contact
± 8 kV 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%.
Electrical fast transient/
burst
IEC61000‑4‑4
± 2 kV for power supply
lines
± 1 kV for input/output
lines
In compliance
Mains power quality should be
that of a typical commercial or
hospital environment.