Description

SDC3 Product Description

The SDC3 is a computer-based unit that records, manages, and archives digital images and videos of surgical procedures. The SDC3 simplifies file 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-specific 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.

SDC3 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 specifications. 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 field. The SDC3 is intended for use by qualified physicians and qualified operating room personnel who have complete knowledge of surgical procedures.

SDC3 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 fixation, 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, and plastic surgeons, orthopedic surgeons, ENT surgeons, and urologists.

SDC3 Contraindications

There are no known contraindications.