BLADDERSCAN BVI 9400 - Bluetooth Wireless Technology; Electromagnetic Compatibility; Electromagnetic Emissions

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BLUETOOTH WIRELESS TECHNOLOGY
The Bluetooth
®
technology used in the BladderScan BVI9400 is compliant with:
• Bluetooth Specification as defined and approved by The Bluetooth Special Interests Group.
• Logo certification with Bluetooth wireless technology as defined by The Bluetooth Special Interest
Group.
ELECTROMAGNETIC COMPATIBILITY
The BladderScan BVI9400 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 BladderScan BVI9400 system complies with the applicable essential performance requirements specified
in IEC 60601‑1 and IEC 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9400 system, see Essential Performance on
page2.
ELECTROMAGNETIC EMISSIONS
Table 29. 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 BladderScan BVI9400 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9400 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