BLADDERSCAN BVI 6100, Руководство по эксплуатации и техническому обслуживанию

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Operations & Maintenance Manual: Product Specifications
ELECTROMAGNETIC COMPATIBILITY
The BladderScan BVI 6100 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
60601‑2‑37. 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 systems, see
Essential Performance on page 1.
ELECTROMAGNETIC EMISSIONS
Table 12. Guidance and Manufacturer’s Declaration—Electromagnetic Emissions
The BladderScan BVI 6100 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 BladderScan BVI 6100 system uses RF energy only for 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 BladderScan BVI 6100 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 13. Guidance and Manufacturer’s Declaration —Electromagnetic Immunity
The BladderScan BVI 6100 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%.