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About Your Product
Product Description
The SDC3 is a computer-based unit that records, manages, and archives digital images and videos
of surgical procedures� The SDC3 simplies le management by recording surgical photos and
videos to compact digital media, such as CDs, DVDs, Compact Flash Cards, USB Hard Drive, or
USB storage devices, which can then be viewed from a personal computer, a DVD player, or from
the SDC3 itself� The SDC3 records images and videos on a built-in hard drive, where they can be
easily accessed after the surgical procedure� The media stored on the hard drive can be tagged
with patient-specic information and burned to digital media using a touchscreen control panel
located on the front of the unit� This media can also be sent at the push of a button to the Studio3
Media Server for long-term storage and browser-based accessibility�
Intended Use
The SDC3 is intended to electronically capture, transfer, store and display medical device
data independently of the functions or parameters of any connected medical device� It is also
intended to convert medical device data from one format to another in accordance with preset
specications� The SDC3 is intended for use as a secondary display for regulated medical devices
and is not intended to calculate or modify any received data or provide primary diagnosis or
treatment decisions� It is not intended for use for active patient monitoring�
The SDC3 is a non-sterile reusable device not intended for use in the sterile eld� The SDC3 is
intended for use by qualied physicians and qualied operating room personnel who have
complete knowledge of surgical procedures�
Indications
The SDC3 is indicated for use with compatible endoscopic and general surgery devices� The SDC3
can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic
surgery wherever a laparoscope/endoscope/arthroscope is indicated for use�
A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy,
laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node
dissection, laparoscopically assisted hysterectomy, laparoscopic and thoracoscopic anterior spinal
fusion, anterior cruciate ligament reconstruction, knee arthroscopy, shoulder arthroscopy, small
joint arthroscopy, decompression xation, wedge resection, lung biopsy, pleural biopsy, dorsal
sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass,
coronary artery bypass grafting where endoscopic visualization is indicated, and examination of
the evacuated cardiac chamber during performance of valve replacement�
SDC3 users are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic
surgeons, orthopedic surgeons, ENT surgeons, and urologists�
Contraindications
There are no known contraindications�
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