Terms And Conditions; Declarations Of Conformity - NDS Zerowire G2 Instrucciones

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Terms and Conditions

8.1

Declarations of Conformity

FCC and Council Directives of European Standards
This device complies with Part 15 of FCC rules and 2017/745 Medical Device Regulation of European Union.
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 undesirable res-
ults.
1. Use the attached specified cables with the color monitor so as not to interfere with radio and television re-
ception. Use of other cable and adapters may cause interference with other electronic equipment.
2. This equipment has been tested and found to comply with the limits pursuant to FCC part 15 and
CISPR 11. 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.
IEC
This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2.
These limits are designed to provide reasonable protection against harmful interference in a typical medical
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 other devices in the vicinity.
FCC, Council Directives of European Standards, and IEC
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 your dealer or an experienced radio/TV technician for help.
Accessory equipment connected to this product must be certified according to the respective IEC Standards
(i.e., IEC 60950-1 or IEC 62368-1) for data processing equipment and IEC 60601-1 for medical equipment.
Furthermore, all configurations shall comply with the system standard, IEC 60601-1-1. Anyone who connects
additional equipment to the signal input part or signal output part configures a medical system and is there-
fore responsible that the system complies with the requirements of system standard IEC 60601-1-1. Whoever
is responsible for securing the unit to a system needs to ensure that the mounting equipment used with this
product complies to IEC standard 60601-1. If in doubt, consult the technical services department or your local
representative.
FCC
Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursu-
ant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful in-
terference 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.
Terms and Conditions
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