xxviii Preface
This product is in conformity with the requirements of EC Council
directive MDD93/42/EEC on the approximation of the laws of the
Member States relating to medical devices. This product satisfies the
Class B 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.
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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.
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