Bladder Volume Tester User’s Manual V1.02
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Chapter Sixteen Guidance and Manufacturer’s Declaration
This product complies with EMC test standard IEC 60601-1-2
Table 1 - Guidance and manufacturer’s declaration—electromagnetic emission
The equipment is intended for use in the electromagnetic environment specified below. The
customer or the user shall assure that they are used in such an environment.
Emission test Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
This equipment uses RF energy only for their
internal function. Therefore, their RF emissions are
very low and are not likely to cause any interference
in nearby electronic equipment.
RF emissions
CISPR 11
Class A
This equipment is suitable for use in all
establishments other than domestic, and may be
used in domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes, provided the following warning is heeded:
Warning: This equipment/system is intended for
use by healthcare professionals only. This
equipment/system may cause radio interference or
may disrupt the operation of nearby equipment. It
may be necessary to take mitigation measures, such
as reorienting or relocating the equipment or
shielding the location.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker
emissions IEC 61000-3-3
Complies
The use of inappropriate accessory will reduce the performance of the product.
Attention:
1. The use of the accessory, transducer or cable other than those specified may result in
increased emissions or decreased immunity of the system.
2. The system should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, the system should be observed to verify normal
operation in the configuration in which it will be used.
3. The system needs to be specifically for EMC protection, and need to be installed and
maintenance in the environment meeting the following provided EMC information.
4. The system may be interfered with by other equipment, even if that other equipment
complies with CISPR emission requirements.
5.
Prevent electromagnetic interference (Conducted Immunity). Due to technical limitations,
conducted immunity level is limited to 1 Vrms, conducted immunity level higher than 1
Vrms may cause the image display of the system interference and affecting the diagnosis
and measurement. We recommend the system away from the conduction noise source.
6. Operation of the system below minimum amplitude or value of patient physiological signal
may cause inaccurate results.
7. Portable and mobile communications equipment can affect the performance of the system.
See the following tables 1, 2, 3, 4.
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