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General ophthalmic imaging including retinal, corneal, and external structures of the eye.

The Phoenix ICON system is an updated cart based retinal imaging system covering the design changes to date on the predicate device, Phoenix ICON. The Phoenix ICON GO retinal imaging system is a portable version of the predicate device, Phoenix ICON (K170527) including the design changes in the Phoenix ICON system. Both the Phoenix ICON and Phoenix ICON GO are wide-field, handheld, high resolution, real-time retinal imaging devices. They are intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye. The intended users of the Phoenix ICON and Phoenix ICON GO are clinical imaging technicians, ophthalmic technicians, nurses, and physicians. The devices may be used in hospitals, medical clinics, and physician's offices. The Phoenix ICON platform consists of either a cart based (Phoenix ICON) or portable (Phoenix ICON GO) control box used in conjunction with a hand-held camera (Handpiece) using interchangeable LED based light sources (White and Blue light). The Phoenix ICON cart contains an AC mains power attachment, a battery module, a keyboard interface, a monitor, and a computer with Phoenix ICON software. The Phoenix ICON GO contains a portable control box with battery function and has an interface for attachment to a specified laptop computer which runs the Phoenix ICON software. Both systems may be used with a Foot Pedal, White Light Module (standard), Blue Light Module (FA) and/or Diffuser accessory. The Phoenix ICON Handpiece contains a wide-field, high resolution camera is used in three (3) modes, External Imaging (White Light), Retinal Imaging (White Light), and Fluorescein Angiography (Blue Light). For external imaging, the Diffuser accessory is placed over the lens tip to diffuse the light and provide for images of the outer surfaces of the eye. Both Retinal Imaging and Fluorescein Angiography are performed with the glass lens of the Handpiece coupled to the cornea via an imaging gel. In these imaging methods, LED light is emitted into the eye to illuminate the retina for image capture. Both the Phoenix ICON and Phoenix ICON GO are software-controlled systems which can capture either video or still images and store them on the control box (Cart computer or GO laptop) for later review. The Phoenix ICON system may be connected to IT networks under IT supervision.

Skylife™ is intended for the treatment of neonatal unconjugated hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. Skylife™ must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. Skylife™ can be used in a clinical setting or in the home.

Skylife™ is a portable phototherapy light system that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. Skylife™ is designed to provide phototherapy treatment from underneath the baby. The system must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. Skylife™ utilizes blue LEDs to achieve intensities from 25 uW/cm²/nm to >55 uW/cm²/nm, emitting light in a narrow bandwidth between 430-475 nm. This light bandwidth corresponds to the spectral absorption of light by bilirubin. Skylife™ utilizes blue LEDs in this range to achieve peak intensities between 25 to 35, and over 55 uw/cm²/nm at low, high settings. Skylife™ at the Very High setting provides an average intensity of 56.3 uw/cm/nm over the treatment area with peak at 72.4 uw /cm-/nm. Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Phototherapy treatment of neonatal jaundice using Skylife™ can be applied at home or in a hospital. Skylife™ consists of the following components: Light bed and light modules, GelMat, disposable mattress cover (Cloud Swaddle), controller, and power supply.