S02 - ATTACHMENT 1 - SALIENT CHARACTERISTICS OTIS SYSTEM.docx

Attachment 1 – Salient Characteristics 36C24822Q0609

SALIENT CHARACTERISTICS OTIS MOBILE NEXT SYSTEM

Brand Name Optical Coherence Tomography

Manufacture: Abbott Laboratories Manufacturer Part #: 1014932

INTENDED USE/INDICATIONS FOR USE:

The OPTIS integrated measurement system offers wireless Fractional Flow Reserve (FFR) and Optical Coherence Tomography (OCT) with seamless integration into the cath lab and PCI workflow.

· Immediately access FFR and OCT during the Percutaneous Coronary Intervention (PCI)

· Control system functions in the sterile field and review images on the main cath lab monitor boom

· Co-registration linkage between anatomical OCT image data on angiography images

· Automated software features to inform all aspects of PCI planning

System must include the following Characteristics

· Mobile Next Console – Must contain engine, 32GB PC, keyboard, monitors, and power supply Easy to move by a single user. With boom monitor video connection Angiography system connection DICOM‡ server via Ethernet.

· Tableside Controller (TSC) – must provide OCT and FFR/RFR control at tableside Clamps to table rail in procedure room, with wireless + USB Connection to OPTIS Mobile Next (Bluetooth)

· Drive-motor and Optical Controller (DOC) – must drive the OCT imaging catheter that will provide OCT acquisition control, with an established connection with OPTIS™ Mobile Next Console

· Wi-Box System for FFR/RFR – must provide wireless aortic pressure with wireless connection to OPTI Mobile Next (Bluetooth)

· Connectivity Box – must contains the interface to the angio and boom video for the OPTI Mobile Next with a Boom monitor video connection Angiography system connection