Pentax EG-2990i Instructions For Use Manual page 3

Product Overview
These instruments photograph the subject of observation using a solid-state image sensor located at the endoscope tip under the
light transmitted from the processor/light source. The target of the observation is monitored by the physician using the endoscopic
image displayed on the video monitor. The endoscopic procedure is performed by inserting biopsy forceps and other endoscopic
accessories into the instrument channel inlet on the control body.
The bending section angulates in the intended direction and angle by operating the Angulation Control Knobs, air and water is fed
from the distal end of the endoscope by operating the Air/Water Feeding Valve, and air or fluids can be suctioned from the distal
end of the endoscope by operating the Suction Control Valve.
Indication for Use
These instruments are intended to be used with a PENTAX video processor (including light source), documentation equipment,
monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery
within the upper digestive tract including the esophagus, stomach, and duodenum.
Application
Medical purpose: Provide images for optical visualization, recording, and/or diagnostic aid.
Patient populations: Adults and pediatrics who have been determined by the physician to be appropriate candidates for the use of
these instruments.
Intended anatomical area: Upper gastrointestinal tract (the esophagus, stomach, and duodenum)
User: Medical doctors (experts approved by the medical safety officer to perform endoscopic examinations at each medical facility)
Place of use: Medical facility
Functions Used Frequently
The frequently used functions in this model are as follows:
• Angulation capability using control knob
• Remote control operation using remote buttons
• Air/Water feeding function
• Suctioning function
Removable Components
OF-B118 Water jet connector cap
OF-B120 Suction control valve
OF-B161 Suction Channel Selector (for EG-3890TK only)
OF-B188 Air/Water feeding valve
OF-B190 Inlet seal
OE-C12 Water jet check valve adapter
Notes
Read this Instructions for Use (IFU) before operating, and save this book for future reference. Failure to read and thoroughly
understand the information presented in this IFU, as well as those developed for ancillary endoscopic equipment and
accessories, may result in serious injury including infection by cross contamination to the patient and/or user. Furthermore,
failure to follow the instructions in this IFU or the companion Instructions for Use (reprocessing) may result in damage to, and/or
malfunction of, the equipment.
It is the responsibility of each medical facility to ensure that only well educated and appropriately trained personnel, who are
competent and knowledgeable about the endoscopic equipment, antimicrobial agents/processes and hospital infection control
protocol be involved in the use and the reprocessing of these medical devices. Known risks and/or potential injuries associated
with flexible endoscopic procedures include, but are not limited to, the following: perforation, infection, hemorrhage, burns and
electric shock.
This IFU describes the recommended procedures for inspecting and preparing the equipment prior to 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. For the cleaning and maintenance after its use, please refer to the
separate Instructions for Use (reprocessing).
The text contained in this IFU is common for various types/models of PENTAX endoscopes and users must carefully follow only
those sections and instructions pertaining to the specific instrument models appearing on the front cover.
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 service facility.
Sterility Statement
These endoscopes identified in this IFU are reusable semi-critical devices. Since they are packaged non-sterile, they must be
high-level disinfected or sterilized BEFORE initial use. Prior to each subsequent procedure, they must be subjected to an