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Chapter 2: Safety and Regulatory

Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 2-25

Digital Detector Labels

Refer to the Digital Detector chapter for information on the Digital Detector labels.

Regulatory Requirements

Note: This equipment generates, uses, and can radiate radio frequency energy. The equipment may

cause radio frequency interference to other medical and non-medical devices and radio commu-

nications. To provide reasonable protection against such interference, this product complies with

emission limits for Group 1 Class A Medical Devices as stated in EN 60601-1-2. However, there is

no guarantee that interference will not occur in a particular installation.

Note: If this equipment is found to cause interference (which may be determined by switching the

equipment on and off), you (or qualified service personnel) should attempt to correct the problem

using one or more of the following measures:

- Reorient or relocate the affected devices.

- Increase the space separating the equipment and the affected device.

- Power the equipment from a source different from that of the affected device.

- Consult the point of purchase or the service representative for further suggestions.

Note: The manufacturer is not responsible for any interference caused either by the use of interconnect

cables other than those recommended or by unauthorized changes or modifications to this

equipment. Unauthorized changes or modifications could void the user’s authority to operate the

equipment.

Note: To comply with the regulations applicable to an electromagnetic interface for a Group 1 Class A

Medical Device, all interconnect cables to peripheral devices must be shielded and properly

grounded. The use of improperly shielded and grounded cables may result in the equipment

causing radio frequency interference in violation of the European Union Medical Device directive

and Federal Communications Commission regulations.

Note: Do not use devices which intentionally transmit radio frequency (RF) signals (cellular phones,

transceivers, or radio controlled products) in the vicinity of this equipment, as it may cause per-

formance outside the published specifications.

Keep the power to these type devices turned off when near the equipment.

The medical staff in charge of this equipment is required to instruct technologists, patients, and other

people who may be around this equipment, to fully comply with the above requirement.

Installation instructions for this device may be found in Optima XR200amx/220amx Installation Manual

5336113-1EN, which is included with this equipment.

This product complies with the following requirements:

Council Directive 93/42/EEC concerning medical devices when it bears the following CE marking of con-

formity:

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