Indications, Warnings, and Risks
Indications For Use:
The SKOUT® system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance.
The SKOUT® system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT® suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT® is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT® is indicated for white light colonoscopy only.
Contradictions and Warnings:
- Do not use the SKOUT® system for any unintended uses, applications, or indications.
- The SKOUT® system is not intended to provide primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/ course of action for patients.
- Do not use the SKOUT® system for any malicious intent.
- Any subsequent clinical decisions made while using the SKOUT® system should be determined solely by the endoscopist.
- The SKOUT® system makes no judgment on if a potential polyp is adenomatous or neoplastic and cannot help with the decision to resect tissue. Users should rely on their medical training to make resection decisions.
- User over-reliance on the software notification rather than relying on their own clinical decisions may lead to false positives or false negatives. Please note that the device is an assistive tool and not a replacement for clinical decision-making.
- Only items that have been specified as part of the SKOUT® system or specified as being compatible with the SKOUT® system should be connected to any of the SKOUT® system components.
- This product should not be used in the presence of fluid that can come into contact with any of the electronic components or wiring.
- Do not attempt to open the device enclosure. There may be exposed wires or sensitive components inside which may cause a malfunction or electrical shock.
Fire or Explosion Risks
- Do not use the SKOUT® system in a highly oxygen-enriched environment, such as a hyperbaric chamber or oxygen tent.
- Do not use the SKOUT® system in the presence of flammable gaseous mixtures or in close proximity to flammable anesthetic gasses.
- Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should not be used closer than 30 cm (12 inches) to any part of the SKOUT® system, including cables specified by the manufacturer.
- Avoid the use of RFID technology near the SKOUT® system as it may lead to electromagnetic interference causing degradation in the essential performance of the SKOUT® system.
- Using the SKOUT® system in close proximity with other electrical equipment may result in electromagnetic interference problems. This can be mitigated by increasing the separation distance between the SKOUT® system and any nearby electrical equipment. If the SKOUT® system and the other equipment are in close proximity, both equipment should be observed to verify that they are operating normally.
- Potential use of electrocautery devices may cause electromagnetic interference and hence avoid concurrent use of the SKOUT® system and electrocautery devices.
- The SKOUT® system is not user repairable. Repairs must be performed only by a qualified service representative.
Connection and disconnections
- End users should not attempt to install, alter, or remove the SKOUT® system on their own, outside of the procedures outlined in this instructions for use.