Ameda Pearl Mode D'emploi page 23

14.2 Electromagnetic Compatibility
IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC COMPATIBILITY (EMC) This electrical
medical equipment needs special precautions regarding EMC and shall be put into service according to the EMC
information provided in this user manual. The equipment conforms to IEC 60601-1-2 for both immunity and
emissions. Nevertheless, special precautions need to be observed. This equipment is intended for Home Healthcare
environment.
The essential performance of the Ameda Pearl Electric Breast Pump is to maintain user-selected levels of
pump speed and vacuum pressure not to exceed 250mmHg + 25mmHg. The pump was tested for immunity to
electromagnetic disturbances and passed according to this criteria.
!
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
! WARNING: Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
TABLE 1
Guidance and declaration of manufacturer-electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
Emissions test
Radiated emissions
CISPR 11
Conducted emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/flicker emissions
IEC 61000-3-3
FCC STATEMENT
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This
device may not cause harmful interference, and (2) this device must accept any interference received, including
interference that may cause undesired operation.
Caution: changes or modifications to this device not expressly approved by Ameda may void the user's authority
to use the device.
Note:
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part
15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference
in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular installation. If this equipment does
cause harmful interference to radio or television reception, which can be determined by turning the equipment
off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
Note:
This equipment has been tested and found to comply with the immunity test levels in AIM 7351731 Rev. 2.0
(2017), Medical Electrical Equipment & System Electromagnetic Immunity Test for RFID Readers.
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Compliance
Group 1, Class B
Group 1, Class B
Class A
Complies
Electromagnetic environment - guidance
The device uses RF energy only for its
internal function. Therefore, its emissions
are very low and are not likely to cause
any interference in nearby electronic
equipment.
The device is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes.