Pentax EPK-i7010 Instructions For Use Manual page 3

White light is captured from a 300 Watt xenon lamp housed in the PENTAX Medical EPK-i7010 video
processor. All visualization is done with the white light mode first. White light (BGR) illuminates the tissue and
transfers the captured light through the video scope or a charged coupled device (CCD). Note that the white
light visualization mode is always used first by the physician. For i-Scan image enhancement, the modification
of the combination of RGB components for each pixel occurs when the i-Scan function is turned on in the
PENTAX Medical EPK-i7010 video processor. The resulting i-Scan image is then displayed on the observation
monitor. For OE image enhancement, one of the two optical filters corresponding to Mode1 and Mode2 are
inserted into illumination light path when the OE function is turned on in the PENTAX Medical EPK-i7010 video
processor. The resulting OE image is then displayed on the observation monitor.
FUNCTIONS USED FREQUENTLY:
The functions used frequently on this equipment are the still image display function, image capture function,
white balance adjustment function, and patient information registration/display function.
APPLICATION:
Intended medical use: Observation of body cavities (Lighting and air/water supply through a connected
1
Patient populations:
2
Intended anatomical area (tissues/organs):
3
User:
4
Usage environment:
5
IMPORTANT:
This Instructions for Use (IFU) describes the recommended procedures for inspecting and preparing this video
processor prior to its use and the care and maintenance after its use. It does not describe how an actual procedure
is to be performed, nor does it attempt to teach the beginner the proper technique or any medical aspects
regarding the use of the equipment.
Failure to follow the instructions in this IFU may result in damage to and/or malfunction of the equipment.
If you have any questions regarding any of the information in this IFU or concerns pertaining to the safety
and/or use of this equipment, please contact your local PENTAX Medical service facility.
After the product has been delivered, promptly install, set up, and start using the equipment. Avoid storing the equipment
over an extended period of time without using.
TRADEMARKS:
• PENTAX is either registered trademark or trademark of HOYA Corporation.
• PENTAX Medical is the trademark of HOYA Corporation.
• Windows 7, Windows 7 Ultimate, Windows Media Player are either registered trademarks or trademarks of
Microsoft Corporation in the United States and/or other countries.
• All other product names mentioned in this IFU provided with this processor are registered trademarks or
trademarks of their respective manufacturers.
endoscope and monitor output of observed images from the endoscope itself)
Patients ranging from pediatric to adult (Patients who are considered suitable for the
application of equipment by the physician)
Pharynx; Larynx; Esophagus; Stomach; Duodenum; Small Intestine; Large Intestine;
Pancreatic and Biliary Duct; Trachea; Bronchial Tree; Ear; Nasal Passage; Kidney;
Renal Cavity; Renal Calyces; Urethra; Endometrial Canal (all require endoscope
connection)
An operator with experience, or an operator working under the supervision of
someone with experience
Hospitals, Ambulatory Surgery Centers, and Medical Clinics