Central venous catheter navigation system(Sherlock 3CG+ Tip Confirmation System ) - India CDSCO Medical Device Registration

Product Information

The Sherlock 3CG+Tip Confirmation System (Site~Rite8 Ultrasound System) is indicated for navigation and positioning of central venous access devices (Site~Rite8 Ultrasound System) of at least 2 Fr in size. The Sherlock 3CG+ TCS provides real-time catheter tip location information by using catheter navigation technology along with the patient’s Cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for CVAD tip placement confirmation of approaches from the superior vena cava. In adult patients and in adolescents (Site~Rite8 Ultrasound System), the Sherlock 3CG+ TCS can be used with CVADs such as peripherally inserted central catheters (Site~Rite8 Ultrasound System), central venous catheters (Site~Rite8 Ultrasound System), implantable ports and hemodialysis catheters; in children (Site~Rite8 Ultrasound System), in infants (Site~Rite8 Ultrasound System), and in neonates (Site~Rite8 Ultrasound System), the Sherlock 3CG+ TCS can be used with PICCs and with centrally inserted central catheters (Site~Rite8 Ultrasound System). In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD’s indications and instructions for use. Limiting but not contraindicated situations for this method are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, Atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients who are easily identifiable prior to catheter insertion, the use of an additional method is required to confirm catheter tip location.