Safety and Regulatory Information6H4866-02 11Section 1: Safety and Regulatory InformationIntroductionThe information contained herein is based on the experience and knowledge relating to the subject matter gained byCarestream Health prior to publication. No patent license is granted by this information.Carestream Health reserves the right to change this information without notice, and makes no warranty, express orimplied, with respect to this information. Carestream Health shall not be liable for any loss or damage, includingconsequential or special damages, resulting from any use of this information, even if loss or damage is caused byCarestream Health's negligence or other fault.CautionCautions point out procedures that you must follow precisely to avoid damage to the system or any of its components,yourself or others, loss of data or corruption of files in software applications.NoteNotes provide additional information, such as expanded explanations, hints, or reminders.ImportantImportant highlights critical policy information that affects how you use this guide and this productGeneral Safety Guidelines• This product is designed and manufactured to ensure maximum safety of operation. Operate and maintain it instrict compliance with the safety precautions and operating instructions contained in this guide.• This product meets all the safety requirements applicable to medical equipment. However, anyone attempting tooperate the system must be fully aware of potential safety hazards• There are no user serviceable parts in this system. The product must be installed, maintained, and serviced byqualified service personnel according to procedures and preventive maintenance schedules in the productservice guide. If your product does not operate as expected, contact your Service Representative.• The product in whole or in part may not be modified in any way without prior written approval from CarestreamHealth.• Personnel operating and maintaining this system should receive training and be familiar with all aspects ofoperation and maintenance.• To ensure safety, read all user guides carefully before using the system and observe all Cautions, “Importants”,and Notes located throughout the guide.• Keep this guide with the equipment. Reading this guide does not qualify you to operate, test, or calibrate thissystem.• Unauthorized personnel are not allowed access to the system.• If the product does not operate properly or fails to respond to the controls as described in this guide:– Follow the safety precautions as specified in this guide.– Stop using the system and prevent any changes to it.– Immediately contact the service office, report the problem, and await further instructions.• Use only legally marketed cassettes. Check periodically the quality of the cassettes, and replace if any defectsare apparent.• The images provided by this system are intended as tools for the trained user. They are explicitly not to beregarded as a sole incontrovertible basis for clinical diagnosis.• Be aware of the product specifications and of system accuracy and stability limitations. Consider these limitationsbefore making a decision based on quantitative values. If you have any doubts, consult the Sales Representative.• This system is Class I continuous operated stationary equipment without applied parts and has one signal input/output part.
