STATEMENTS AND DECLARATIONS:
1. MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information provided in
the ACCOMPANYING DOCUMENTS
2. Wireless communications equipment such as wireless home network devices, mobile
phones, cordless telephones and their base stations, walkie-talkies can affect this
equipment and should be kept at least a distance d = 3,3 m away from the equipment.
(Note. As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell
phone with a maximum output power of 2 W yields d = 3,3 m at an IMMUNITY LEVEL of
3 V/m)
3. The manufacturer are available for request of circuit diagrams, component part lists,
descriptions ,calibration instructions ,or other information that will assist service
personnel to repair those parts of the device
4. Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
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.
5. Guidance and manufacturer’s delclaration
Guidance and manufacture’s declaration – electromagnetic emission
The
[EQUIPMENT or SYSTEM] i
s
intended for use in the electromagnetic environment specified below. The customer of
the user of the
[EQUIPMENT or SYSTEM]
should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment –
guidance
