Siemens TS2000, Service Manual, Page: 13 / 65

TS2000 Service Manual RD7409290-0 Rev. F
2-3
discomfort or sensation. Since the system does not use radiation, it
allows for more frequent and consistent monitoring of the patient
condition. Over a twelve-year period (with the original prototype
device) and 16,000 clinical examinations, there were no reports of
harm or adverse side affects to the patient or the operator.
TS2000 uses a totally different method of detecting breast disease than
mammography, combining the results of T-Scan with those of
mammography may increase the overall sensitivity and/or specificity.
Similarly, by combining the results of T-Scan with the Clinical Breast
Exam, the diagnostic accuracy of the CBE as performed by primary
care physicians should be dramatically improved and quantified for
more reliable pre-mammographic screening. The overall outcome of
using the T-Scan system should reduce the rate of missed tumors and
unnecessary biopsies, and their associated financial and emotional
costs.
2.1.3 Comparison with Other Methods of Breast
Examination
NOTE:
TS2000 should always be used in conjunction with
other methods of breast examination (CBE,
mammography, ultrasound) and not as a stand-alone
device.
Mammography detects breast disorders by using radiation to identify
variation in tissue density. In contrast,
TS2000 uses no ionizing
radiation and detects changes in electrical impedance. Because
TS2000 uses a totally different method of detecting breast disease than
mammography, combining the results of TS2000 with those of
mammography may increase overall sensitivity and/or specificity of
diagnosis.
Similarly, pre-mammographic screening by means of clinical breast
exam (CBE) can be made more accurate when CBE is used in
conjunction with T-Scan.
SPB7-520.840.01.01.02