limits for a computing device in accordance with the specifications in Subpart J of Part 15 of FCC
Rules, which are designed to provide reasonable protection against such interference when
operating in a commercial environment. Operation of the equipment in a residential area is likely to
cause interference, in which case the user, at his own expense, will be required to take whatever
measures may be appropriate to correct the interference. If your imager does cause interference to
radio or television reception, you are encouraged to try to correct the interference by one or more
of the following measures:
•
Reorient the receiving antenna
•
Relocate the imager with respect to the receiver
If necessary, you should consult Codonics technical support or an experienced radio/television
technician for additional suggestions. You may find the following booklet prepared by the Federal
Communications Commission helpful:
How to Identify and Resolve Radio-TV Interference Problems
.
This booklet is
available from the U.S. Government Printing Office, Washington, D.C. 20402, Stock
No. 004-000-00345-4.
This product is in conformity with the requirements of EC Council directive MDR 2017/745/EU (CE)
on the approximation of the laws of the Member States relating to medical devices. This product
satisfies the Class A limits of IEC60601-1-2 and CISPR 11. A declaration of conformity with the
requirements of the Directive has been signed by the Director of Operations. Horizon is approved
for export via FDA Certificates to Foreign Government and registered as a medical device for import.
A current list of countries is available on request.
Guidance Regarding Electromagnetic Emissions and Immunity
Suitable Environments:
•
Horizon is intended for use in professional healthcare facility environments, including hospitals
and medical clinics.
•
Horizon has not been evaluated for use near HF surgical equipment. If use near HF surgical
equipment is desired, the user is responsible for verifying proper operation of the Horizon. If
Horizon does not perform correctly in this environment, move the Horizon farther from the
source of the electromagnetic disturbance.
•
Horizon has not been evaluated for use in emergency medical vehicles.
As a support device, Horizon does not provide essential performance.
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.
WARNING Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Horizon,
its cables, or accessories. Otherwise, degradation of the performance of this equipment could result.
