Pentax EPK-i7010 Instructions For Use Manual page 2

INDICATION FOR USE:
The PENTAX Medical EPK-i7010 Video Processor is intended to be used with the PENTAX camera heads,
endoscopes, light sources, monitors and other ancillary equipments for endoscopic diagnosis, treatment and video
observation.
The PENTAX Medical EPK-i7010 includes a digital post-processing imaging enhancement technology (PENTAX
i-Scan™) and a optical imaging enhancement technology (OE). These imaging enhancement technologies are
intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace
histopathological sampling. i-Scan and OE are compatible with PENTAX video endoscopes.
DEVICE DESCRIPTION:
The PENTAX Medical EPK-i7010 video processor consists of a video system, integrated light source, monitor,
and ancillary equipment. This processor is intended for endoscopic diagnostic, treatment and video
observation.
The PENTAX Medical EPK-i7010 video processor contains two types of contrast enhancement techniques:
PENTAX i-Scan technology, and optical enhancement (OE) technology. PENTAX i-Scan technology is a digital
filter-based contrast enhancement technique, while OE technology combines the band limited light and the
digital processing.
PENTAX i-Scan technology has three modes, i-Scan 1, 2 and 3. i-Scan 1 enhances image topography and
edges and i-Scan 2 and 3 enhances the color tone of the image by dissecting and recombining the individual
red, green and blue (RGB) components of a white light image.
PENTAX i-Scan modes 1, 2, and 3, are intended to give the user an enhanced view of the texture of the mucosal
surface and blood vessels. i-Scan 1 provides the user with a view that sharpens surface vessels and enhances
surface texture of the mucosa. i-Scan 2 provides the user with increased visibility of blood vessels while also
providing the same enhancements to the mucosa achieved in i-Scan 1. i-Scan 3 provides the user with
increased visibility of blood vessels including dimly illuminated far-field regions while also providing the same
enhancement to the mucosa achieved in i-Scan 1. The user can select either white light image or i-Scan modes
by pressing a pre-programmed button on the scope, by using a pre-programmed foot pedal or by pressing a
keyboard button. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy
and is not intended to replace histopathological sampling.
The PENTAX Medical EPK-i7010 video processor is equipped with two optical filters placed inside Xenon lamp
light path to provide optical enhancement (OE), which combines the band limited light and the digital
processing. PENTAX OE technology has two modes, OE Mode1, 2.
In addition to i-Scan, OE Mode1 and 2 are intended to provide alternative methods to improve blood vessel
visibility (emphasizes mucosal microvasculature and fine mucosal structures) on the mucosal surface by
combination of band limited light illumination source. OE Mode1 uses a spectral filter that transmits band limited
green and blue light and is intended to provide the user with enhanced image of blood vessels and fine structure
of mucosa. OE Mode2 uses a different spectral filter that transmits band limited red, green and blue light and
is intended to provide the user with enhanced image of blood vessels and fine structure of mucosa in an image
closer to white light image.
The user can select either white light image or OE modes by pressing a pre-programmed button on the scope,
by using a pre-programmed foot pedal or by pressing a keyboard button. OE is intended to be used as an
optional adjunct following traditional white light endoscopy and is not intended to replace histopathological
sampling.