BLADDERSCAN BVI 3000 - ELECTROMAGNETIC COMPATIBILITY; ELECTROMAGNETIC EMISSIONS & IMMUNITY

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ELECTROMAGNETIC COMPATIBILITY
BladderScan BVI 3000 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 specied in this standard are designed to provide reasonable protection against harmful interference in
a typical medical installation.
In addition, the BVI 3000 detects outside interference and displays RESCAN instead of a volume
measurement if the detected interference is of sufcient magnitude to possibly compromise measurement
accuracy. If you experience this display repeatedly, see the entry "Rescan (Interference)" in the procedure
Troubleshoot an Error Message on page 42.
The BladderScan BVI 3000 system complies with the applicable essential performance requirements specied
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 BladderScan BVI 3000 system, see Essential Performance on page 1.
ELECTROMAGNETIC EMISSIONS
Table 11. Guidance and Manufacturer’s Declaration—Electromagnetic Emissions
The BladderScan BVI 3000 system is intended for use in the electromagnetic environment specied below. The
customer or the user of the BladderScan BVI 3000 system should assure that it is used in such an environment.
EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT – GUIDANCE
RF emissions
CISPR 11
Group 1
The BladderScan BVI 3000 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 BladderScan BVI 3000 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 uctuations/
icker emissions
IEC 61000‑3‑3
Complies