Selenia User Guide
Chapter 1—Introduction
2 MAN-03270 Revision 003
1.1.1 Indications For Use
The Selenia Full Field Digital Mammography System generates digital mammographic
images that can be used for screening and diagnosis of breast cancer. The Selenia Full
Field Digital Mammography System is intended for use in the same clinical applications
as traditional screen-film mammographic systems. Mammographic images can be
interpreted on either hard copy film or the diagnostic review workstation.
1.1.2 Contraindications
There are no known contraindications.
1.1.3 Potential Adverse Effects
The following is a list of potential adverse effects that apply to mammography and are
also applicable to digital mammography using the Selenia.
• Excessive breast compression
• Excessive x-ray exposure
• Electric shock
• Infection
• Skin irritation, abrasions, or puncture wounds
1.2 Intended Use for the User Guide
Always refer to the User Guide for instructions on using the system.
1.3 Summary of Clinical Studies
This information is available in the document MAN-02233.
1.4 Product Complaints
Report any complaints or problem in the quality, reliability, safety, or performance of this
product to Hologic. If the device has caused or added to patient injury, immediately
report the incident to Hologic. (See the title page for contact information.)
1.5 Technical Support
Refer to the title page of this manual for contact information for product support.
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